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CorMedix(CRMD)2026年第2四半期決算説明会:売上高は1億190万ドルに到達、EBITDAガイダンスを上方修正

TradingKeyAug 14, 2026 8:12 AM
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CorMedixの2026年第2四半期は、連結売上高が1億190万ドル、純利益が2,600万ドルと大幅な増収増益を記録した。主力のDefenCathは全米上位5大透析事業者すべてとの供給体制を確立し、7月の発注量も予想に沿って推移している。通期売上高見通しを据え置く一方、調整後EBITDA予想は1億2,500万〜1億4,000万ドルに引き上げた。また、Rezzayoの第3相試験が主要評価項目を達成し、第3四半期中のsNDA提出に向け準備が進められている。四半期末の現金等は2億5,670万ドルとなり、堅固な財務基盤を維持している。

AI生成要約

主なポイント

  • CorMedixが発表した2026年第2四半期の連結売上高は1億190万ドルとなり、2025年第2四半期の3,970万ドルから増加しました。DefenCathが6,610万ドル、買収したMelintaのポートフォリオが3,580万ドルを寄与しました。
  • 調整後EBITDAは前年同期の2,240万ドルから5,870万ドルに増加しました。純利益は2,600万ドルで、基本1株当たり利益(EPS)は0.33ドル、希薄化後1株当たり利益は0.29ドルでした。
  • 同社は2026年通期の売上高見通し(3億2,500万〜3億4,500万ドル)を据え置く一方、調整後EBITDAの見通しを1億2,500万〜1億4,000万ドルに引き上げました。
  • CorMedixは別の大型人工透析事業者とDefenCathの複数年供給契約を締結し、全米上位5社の人工透析提供事業者のすべてをカバーすることになりました。数百か所のクリニックが参加すると見込まれるパイロットプログラムが2026年第3四半期に開始される予定です。
  • 侵襲性真菌症予防を目的としたRezzayoの第3相ReSPECT試験は、FDAの主要評価項目を達成しました。CorMedixとMundipharmaは、2026年第3四半期に予定されている適応追加申請(sNDA)の提出に向け協力しています。
  • 四半期末時点の現金および現金同等物は計2億5,670万ドルとなり、2026年上半期の営業キャッシュフローは1億2,860万ドルに達しました。

主要財務実績

指標2026年第2四半期2025年第2四半期解説
連結売上高1億190万ドル3,970万ドル買収したMelintaポートフォリオの全四半期分を含む
DefenCath 売上高6,610万ドル成長は主に2025年中頃の大手透析顧客の導入が牽引
Melintaポートフォリオ売上高3,580万ドルMelintaは2025年8月に買収
営業費用3,420万ドル1,830万ドル統合後のコスト基盤拡大を主因として約87%増加
研究開発費670万ドル240万ドルDefenCathのTPNプログラムを含む人件費および臨床試験費用の増加
販売・マーケティング費用1,240万ドル640万ドルポートフォリオ拡大に伴う人件費およびマーケティング費用の増加により約95%増加
一般管理費1,510万ドル950万ドル弁護士費用の予想保険補填に関連する420万ドルの減少額を含む
純利益2,600万ドル1,980万ドル2026年第2四半期には1,270万ドルの法人税費用が含まれる
希薄化後EPS0.29ドル0.28ドル報告された純利益に基づく
調整後EBITDA5,870万ドル2,240万ドル売上高の伸長および統合されたポートフォリオからの貢献を反映
現金及び現金同等物2億5,670万ドル2026年第2四半期末時点の残高
営業キャッシュフロー(上半期)1億2,860万ドル4,970万ドル前年同期比で大幅増

事業および業績の動向

DefenCathとTDAPA終了後の移行

CorMedixによると、7月のDefenCathの発注量は、2026年業績見通しの前提となっているTDAPA終了後の想定と一致していました。大手人工透析事業者における発注量は安定した一方、中小事業者では一部減少が見られたものの、いずれも経営陣の予想通りでした。

今回の新たな複数年契約により、CorMedixは全米上位5社の人工透析提供事業者のすべてと商業供給体制を構築したことになります。直近の顧客は初回収注を行い、2026年第3四半期にパイロットプログラムを開始する予定です。経営陣は、同パイロットプログラムには数百のクリニックが参加し、2027年には利用拡大の可能性があると試算しています。

CorMedixはまた、2026年第3四半期および第4四半期の価格設定に対応するため、主要顧客との契約を変更しました。一部の変更には2027年の価格および数量のコミットメントが含まれており、償還制度の移行期における見通しが改善しました。

メディケア・アドバンテージ(民間医療保険)との契約締結は、引き続き長期的な成長の焦点となっています。経営陣によると協議は進展しているものの、契約サイクルが長くなる可能性があると指摘しています。なお、同社の2026年業績見通しにはメディケア・アドバンテージからの貢献は含まれていません。

第4四半期に開催される米国腎臓学会(ASN Kidney Week)およびIDWeekにおいて、DefenCathに関する追加のリアルワールドエビデンスが発表される予定です。予定されている発表には、U.S. Renal Care研究の最終結果や、クロルヘキシジン抗菌キャップを併用したDefenCathに関する外部研究、ならびにtPA使用削減に伴う潜在的な臨床的・経済的メリットに関する研究が含まれています。

Rezzayo 予防プログラム

第3相ReSPECT試験は、90日時点での真菌非感染生存率というFDAの主要評価項目を達成し、事前定義された許容範囲内で標準的な抗真菌療法に対する非劣性を示しました。経営陣はまた、投与量の変更、中止、または治験脱落に至る治療起因の有害事象を含む、副次的な安全性評価項目全体においても良好な結果が得られたと言及しました。

FDAとの新薬承認申請前(pre-NDA)協議を経て、CorMedixはMundipharmaと協力し、2026年第3四半期中に侵襲性真菌症予防におけるRezzayoの適応追加申請(sNDA)を提出できるよう支援を進めています。2026年第4四半期には、1つ以上の医学会でさらなる第3相データが発表される予定です。

現在、米国での新薬承認(NDA)はMundipharmaが保有しています。両社の合意に基づき、予防適応症に関する追加申請が承認された後、所有権はCorMedixに移管される予定です。

DefenCath TPN試験

CorMedixは、一部の除外基準を絞り込むための治験実施計画書(プロトコル)の改訂を提出し、第3相完全高カロリー輸液(TPN)試験のための追加施設を開設しました。経営陣は引き続き2028年の試験完了を見込んでいます。

経営陣による業績見通し

2026年通期業績見通しレンジ(範囲)状況
連結売上高3億2,500万〜3億4,500万ドル据え置き
DefenCath 売上高1億7,500万〜1億9,500万ドル据え置き
調整後EBITDA1億2,500万〜1億4,000万ドル上方修正
現金支出営業費用1億4,500万〜1億5,500万ドルレンジ縮小。株式報酬などの非現金支出費用を除く

経営陣は、DefenCathの売上高が通期見通しレンジの中央から上限付近に向かって推移していると述べました。同社は、TDAPA終了後の発注パターンに関する見通しがより明確になり次第、業績見通しを再検討する予定です。

Rezzayoの承認可能性に関連する計画投資には、15〜20名の商用および医療分野の追加人員が含まれる見込みです。これらの費用はすでに現金支出営業費用の見通しに反映されています。

リスクと主な注視点

  • 特に中小規模の人工透析事業者において、TDAPA終了後の発注に関する見通しは依然として限られています。
  • 新たに契約した大手人工透析事業者による拡大の時期および規模は、初期パイロットプログラムの結果に依存します。
  • メディケア・アドバンテージの契約サイクルは長く、経営陣は2026年業績見通しにこれに関連する貢献を織り込んでいません。
  • 最終的な末期腎不全(ESRD)償還ルールは、電話会議で議論された提案中の四半期メカニズムとは異なる可能性があります。
  • Rezzayoの最終的な予防適応症のラベル(添付文書記載範囲)は依然としてFDAの審査対象であり、経営陣は最終的な範囲についての見通しをまだ得ていません。
  • Rezzayoの申請および規制当局による承認時期は、適時の申請提出およびFDAによる受理に依存します。

アナリストQ&Aの要点

  • 新規人工透析事業者のパイロットプログラム:経営陣は、初期のDefenCathパイロットプログラムが数百のクリニックを対象とする可能性があると試算しましたが、2027年における潜在的な影響を定量化するのは時期尚早であると述べました。
  • 当四半期の数量:7月の数量は大手事業者間で安定していましたが、中小顧客では一部減少が見られました。経営陣は、普及拡大とメディケア・アドバンテージ契約を主な数量成長のレバーとして挙げました。
  • Rezzayoに関する市場のフィードバック:第3相データの完全なセットがまだ公表されていないため、CorMedixは広範な市場調査をまだ実施していません。2026年第4四半期により多くのデータが見込まれています。
  • 営業費用のランレート:経営陣は、意図的なコスト削減策を講じてはいないと述べました。第2四半期の一般管理費は、主に2026年第1四半期に発生した弁護士費用に関連する270万ドルを含む、420万ドルの保険償還金クレジットにより縮小されました。
  • 商業インフラ:経営陣は、TDAPA終了後の償還期間を前に、DefenCathの販売およびマーケティングインフラを削減する措置は講じられていないことを確認しました。

決算説明会文字起こし全文


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

Today's conference call is being recorded. [Operator Instructions] At this time, I would like to turn the conference call over to Dan Ferry from LifeSci Advisors. Please go ahead.

質疑応答

Daniel Ferry

Good morning, and welcome to the CorMedix Second Quarter 2026 Earnings and Corporate Update Conference Call. Leading the call today is Joseph Todisco, Chairman and Chief Executive Officer of CorMedix. We're joined by Elizabeth Masson-Hurlburt, EVP and Chief Operating and Commercial Officer, and Susan Blum, EVP and Chief Financial Officer. In addition, Beth Zelnick Kaufman, EVP and Chief Legal and Compliance Officer and Corporate Secretary, and Dr. Matt David, EVP and Chief Business Officer, are on the line and will be available during the Q&A session.

Before we begin, I would like to remind everyone that during the call, management may make what are known as forward-looking statements within the meaning set forth in the Private Securities Litigation Reform Act of 1995. These statements are statements other than statements of historical fact regarding management's expectations, beliefs, goals, and plans, about the company's prospects and future financial position.

Actual results may differ materially from the estimates and projections on which these statements are based due to a variety of important factors, including the risks and uncertainties described in greater detail in CorMedix filings with the SEC, which are available free of charge at the SEC's website or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in these forward-looking statements. An investor should not place undue reliance on these statements. CorMedix does not intend to update these forward-looking statements, except as required by law.

During this call, the company will discuss certain non-GAAP [indiscernible] on Form 8-K, filed with the SEC. This information is also available on the Investor Relations section of CorMedix's website. At this time, it is now my pleasure to turn the call over to Joseph Todisco, Chairman and Chief Executive Officer of CorMedix. Joe, please go ahead.

Joseph Todisco

Thank you, Dan. Navigate the evolving post-TDAPA landscape, meaningfully advancing our high-value pipeline, highlighted by the positive Phase 3 ReSPECT data for Rezzayo, and now working collaboratively with Mundipharma towards their submission of the sNDA for Rezzayo in the prophylaxis of invasive fungal disease. And lastly, deploying our capital in a disciplined manner to drive long-term value for shareholders while building an increasingly diversified and resilient business.

We announced this morning second quarter consolidated revenue of $101.9 million and adjusted EBITDA of $58.7 million. Susan will provide more granular details of second quarter financial results. Today we also announced that we've signed a multi-year commercial supply agreement for DefenCath with an additional large dialysis organization, or LDO. With this agreement, CorMedix now has commercial supply agreements in place with all 5 of the top dialysis providers in the U.S.

The newly signed LDO has placed an initial order and will initially begin a pilot of DefenCath in the third quarter of this year with a potential opportunity to expand utilization in 2027. We view the signing of this agreement as an important milestone and validation of DefenCath's clinical value proposition with the largest providers in the U.S. dialysis market.

Turning to guidance, we are reaffirming our full-year 2026 revenue guidance with a range of $325 million to $345 million, and raising our full-year adjusted EBITDA guidance to a new range of $125 million to $140 million. We will revisit guidance as the year progresses and as we gain additional visibility into post-TDAPA ordering patterns. While we're only a few weeks into the third quarter, DefenCath order volumes in July have tracked consistent with the post-TDAPA forecast underlying our financial guidance.

In addition to the new LDO agreement, we have signed contract amendments with our major customers covering third and fourth quarter 2026 pricing and in some instances pricing and volume commitments for 2027. These amendments give us improved visibility into pricing and utilization through year-end and are designed to keep patients on therapy through the reimbursement transition. We continue to focus significant internal resources on the DefenCath growth strategy through Medicare Advantage contracting, and I'm pleased with the progress of those discussions. Contracting cycles with these plans can be lengthy, and we have not assumed a contribution for Medicare Advantage in our 2026 guidance. Continually, Medicare Advantage represents a meaningful long-term growth avenue for DefenCath.

DefenCath's clinical value and its potential for meaningful downstream cost savings continue to be supported by a growing body of real-world evidence that our partners are publishing, and we anticipate additional data presentations this fall at the American Society of Nephrology's Kidney Week and at IDWeek.

Turning to our pipeline, we now have top-line results from the ReSPECT study, a Phase 3 clinical study evaluating Rezzayo for the prophylaxis of invasive fungal disease in adult immunosuppressed patients, or IFD. Assuming timely submission and FDA acceptance of the filing, we would anticipate agency action in the first half of the year, including the anticipated addition of 15 to 20 positions across both commercial and medical. These investments are sized to allow us to move quickly at approval while preserving flexibility if regulatory timelines shift and are already reflected in our narrowed full-year cash OPEX guidance of $145 million to $155 million. As a reminder, our cash OPEX guidance excludes non-cash charges such as stock-based compensation.

I would now like to turn the call over to our Chief Operating and Commercial Officer, Elizabeth Masson-Hurlburt, to provide an update on clinical activities. Liz, please go ahead.

Elizabeth Masson-Hurlburt

Thank you, Joe, and good morning, everyone. As Joe mentioned, we were pleased to announce preliminary top-line results of the ReSPECT study at the end of April, and following a constructive pre-NDA meeting with the FDA, are working diligently with our partner, Mundipharma, in support of their submission of the sNDA for Rezzayo in prophylaxis in the third quarter.

As a reminder, the ReSPECT study met its primary endpoint for FDA of fungal-free survival at day 90, showing non-inferiority versus the standard antifungal regimen, or SAR, meeting the pre-specified non-inferiority margin. In addition, results showed a favorable profile across multiple secondary endpoints, most notably in treatment-emergent adverse events leading to dose reduction, interruption or withdrawal of study drugs, and study discontinuation.

As we stated previously, the objective with the ReSPECT study was to show comparable efficacy to standard of care while also demonstrating a favorable overall safety profile with regard to drug-drug interactions and toxicity. We believe the study has achieved this objective and that the results position Rezzayo, if approved, as a differentiated option for prophylaxis of IFD with a meaningful potential commercial opportunity. It's important to remember that this was a global study conducted by our partner, Mundipharma, who owns global IP rights and will pursue regulatory approvals outside of the United States.

Mundipharma is currently the holder of the U.S. NDA and under the terms of our agreement, transfers ownership of the NDA to CorMedix following approval of an sNDA for the prophylaxis indication, at which point CorMedix would own and control the U.S. assets. Under our agreement, the parties must work together on the publication of data and submissions to FDA. In terms of data publication, we currently expect additional data from the Phase 3 ReSPECT study to be published later this year at 1 or more medical conferences during the fourth quarter.

Turning to DefenCath, we also expect additional real-world evidence to be published in the fourth quarter, with multiple abstracts having been submitted to both ASN and IDWeek. Assuming acceptance, these publications will present the final results from the U.S. Renal Care real-world evidence study, which, at interim analysis, showed a meaningful impact on infection-related hospitalizations and catheter-related bloodstream infections, as well as 2 other external studies. The first will highlight the demonstrated efficacy of DefenCath when used in combination with chlorhexidine antimicrobial caps. The second is expected to highlight the clinical and economic benefits of DefenCath in the outpatient hemodialysis setting related to a meaningful reduction in tPA use by facilities.

All combined, we expect that these data will add to the growing body of evidence supporting the clinical and pharmacoeconomic value of DefenCath. Shifting gears to our Phase 3 TPN study, we recently submitted a protocol amendment to FDA that narrows certain exclusion criteria, which we believe can support increased enrollment in the coming months. And we have additionally activated additional sites. We will continue to update investors on our progress as we move through the year, and we continue to expect study completion in 2028. I would now like to turn the call over to Susan to discuss the company's second quarter financial results and financial position. Susan? Thank you.

Susan Blum

Thank you, Liz, and good morning, everyone. We are pleased to announce our second quarter results which reflect strong execution across the business, continued demand for DefenCath, and the contribution from the acquired Melinta portfolio. As a reminder, because the Melinta acquisition closed in August 2025, the second quarter of 2026 is a full quarter of Melinta operations, while the second quarter of 2025 did not. Accordingly, year-over-year comparisons are heavily influenced by the broader product portfolio and cost structure of the combined company. We also filed our Form 10-Q this morning, and I encourage investors to review it for additional details and important disclosures.

Turning to the numbers, second quarter 2026 consolidated revenue was $101.9 million, compared with $39.7 million in the second quarter of 2025. Second quarter revenue included $66.1 million in sales of DefenCath and $35.8 million in revenue associated with the acquired Melinta portfolio. DefenCath sales increased year-over-year largely due to the onboarding of a large dialysis customer in mid-2025. Operating expenses were $34.2 million in the quarter, compared with $18.3 million in the second quarter of 2025, an increase of approximately 87%.

The increase of $15.9 million over the prior year period was driven primarily by the contribution of operating expenses from the Melinta acquisition for the full quarter and reflects the larger combined company. Research and development expenses were $6.7 million in the second quarter of 2026, compared with $2.4 million for the same period in 2025. The increase was due primarily to higher personnel and clinical trial services in support of ongoing clinical programs, including pediatric studies for several [indiscernible] and continued investments in the development of DefenCath for the TPN indications.

Sales and marketing expense increased approximately 95% to $12.4 million in the second quarter of 2026 from $6.4 million in the second quarter of 2025. The increase was due primarily to higher personnel costs associated with a larger product portfolio and related marketing programs. General and administrative expenses increased approximately 59% to $15.1 million in the second quarter of 2026 from $9.5 million in the second quarter of 2025. The increase was driven by higher costs associated with operating as a combined company following [indiscernible], including branded prescription drug fees and higher personnel, information technology, legal, and facilities costs. G&A expenses in the quarter also reflects a reduction to expense of $4.2 million, which represents the amount of expected insurance reimbursement of legal fees incurred by the company to support its ongoing securities litigation.

Of the $4.2 million credit reported in the second quarter, $2.7 million is the amount of credit that the company has incurred related to legal fees that were incurred in prior periods. On the bottom line, CorMedix recorded net income of $26.0 million, or $0.33 and $0.29 per basic and diluted share, respectively, in the second quarter of 2026, compared with net income of $19.8 million, or $0.29 and $0.28 per basic and diluted share, respectively, in the second quarter of 2025. In addition to net revenue and operating expenses, EPS was impacted by income tax expense of $12.7 million, as well as non-operating income and expenses net of approximately $4.2 million associated with the mark-to-market of marketable equity securities and contingent consideration, which reflects the approximate fair value of future milestone and royalties payable to former Melinta shareholders.

On a non-GAAP basis, adjusted EBITDA was $58.7 million for the second quarter of 2026, compared with adjusted EBITDA of $22.4 million in the second quarter of 2025. This adjusted EBITDA metric excludes non-cash items such as depreciation, amortization, and non-GAAP. We ended the second quarter with $256.7 million in cash and cash equivalents for this quarter.

For the first 6 months of 2026, net cash provided by operating activities was $128.6 million, compared with $49.7 million for the first 6 months of 2025. As Joe mentioned, we are confident in our fiscal year 2026 financial guidance, which includes full-year 2026 consolidated revenue of $325 million to $345 million, full-year DefenCath revenue guidance of $175 million to $195 million, and revised full-year adjusted EBITDA guidance of $125 million to $140 million. We continue to believe we are well positioned with a strong balance sheet, meaningful cash generation, and the financial flexibility to support our operating priorities, pipeline development, and shareholder value.

Joseph Todisco

We have a lot of opportunity ahead of us. CorMedix has built meaningful momentum through the first half of 2026 across all 3 pillars of our investment thesis. First, DefenCath continues to perform in line with our internal expectations at the TDAPA expiration, demonstrating durable underlying utilization, which we believe positions the franchise to remain a meaningful value generator following the reimbursement transition. Second, we're advancing a pipeline of high-value late-stage opportunities, including Rezzayo for prophylaxis and DefenCath in TPN, which could meaningfully expand our long-term revenue opportunity.

And third, we have delivered significant profitability in cash generation over the last year. $277.8 million of adjusted EBITDA over the trailing 12 months, and $267 million of combined cash and investments at quarter end allows us to reinvest in growth and pursue business development opportunities. We remain confident in our outlook for this year and our past sustained growth and profitability beyond it. This concludes our prepared remarks, and I'll ask the operator to open up now for questions.

We will now begin the question and answer session.

Operator

[Operator Instructions] Our first question comes from Roanna Ruiz with Leerink. Please go ahead.

Roanna Ruiz

Hi, guys. This is Anna on for Roanna. Thanks so much for taking our question and congrats on the progress. I just wanted to check in on how the new multi-year agreement with the LDO is expected to impact your 2027 expectations and if you could give any color on how long it takes for a new site to reach this steady state production in line with other operators.

Joseph Todisco

Okay, thanks, Anna. So we just recently signed that agreement and they're rolling out a pilot. We're waiting to see kind of actually what they're looking for and we're hopeful for additional utilization. So once we get better visibility, we'll be in a position probably to talk more about 2027. There's a lot of variables that go into 2027 guidance. I don't expect we'll be in a position to comment on it until either late this year or early next year. So there's just a lot of pushes and pulls. We don't have any cause now to either adjust the top or bottom of that guidance, but as we move through the year and we get better visibility, we can provide updates.

Roanna Ruiz

Sure, thanks. And is any of that LDO pilot included in the 2026 guidance?

Joseph Todisco

No, no, right now it's, well obviously it's tracking the revenue, so it's within the revenue that we're seeing from the pilot is within our existing guidance. And for DefenCath, we are right now tracking to the kind of mid-top part of the DefenCath guidance. So let's see where we go through the year. And as I said, we'll update as we go.

Operator

Great. Thanks so much. Our next question comes from Leonid Timoshev with RBC Capital Markets. Please go ahead.

Leonid Timoshev

Hey, guys. Thanks for taking my question. I want to ask on maybe if you can comment on what you're seeing in terms of volume growth in the existing channels thus far in this quarter, just given that we're in the post-TDAPA period now. And then related to that, just as a follow-up, how are you thinking about how you're going to be able to do that?

Joseph Todisco

So, look, in terms of volume growth, I think what we're seeing in July is really kind of stabilized volumes with the larger players, which is what we expected, and some attrition with the really small players, which is also what we expected, with some adoption and or Medicare Advantage contracting. I think we're cautiously optimistic we're making good progress. That, you know, perhaps we have something in place that takes effect early next year and starts to really impact the DefenCath volumes. Those are really the 2 levers that I see, you know, from the DefenCath standpoint. Now, the final ESRD rule, obviously they put out the proposed rule. It was a little bit different than what we were expecting in terms of the quarterly mechanism. I expect there's going to be a lot of comment on that. Not sure if that's actually what will make it into the final rule, but we'll expect the final rule.

Operator

Our next question comes from Jason Butler with Citizens JMP. Please go ahead.

Jason Butler

Hi, thanks for taking the questions. First one, can you give any more color on the size or scope of the pilot study being conducted by the new LDO? And then for Rezzayo and profi, can you talk about, you know, since you had the Phase 3 results, the feedback you're getting from potential prescribers, just what the results are? Perception to that data has been as you think about a potential label expansion. Thank you.

Joseph Todisco

Yes, look, right now the size and scope of the pilot, we've shifted initial order. We think it's a couple hundred clinics. We'll see where we can go from there. I don't want to get out over my skis on the pilot yet, Jason. So right now we're really happy to have finally gotten that LDO kind of over the hump and to the point of commercialization. So we're taking that 1 day by day. On the Rezzayo profi, the full data set is not yet out, so we really haven't been able to conduct a robust market research. As we said in the script, we are working with our partner, Mundipharma. We would expect it to be published later in the fourth quarter at 1 or more medical conferences. And once we have that data...

Operator

Great, thank you. Our next question comes from Serge Belanger with Needham & Company. Please go ahead. Thank you.

Serge Belanger

Hi, good morning. Thanks for taking the question. I guess first on the new LDO, first, congratulations. It's just a pilot program. I guess my question is why did the LDO decide to enter an agreement now? Now when the product has been available for 2 years and I know the company had some meaningful efforts to sign them up. Secondly, on Rezzayo, following your FDA meeting, just curious what your expectations are for potential labeling of the product. I believe a Phase 3 trial was conducted in allogeneic HSCT patients. Curious if you'll be able to address the broad patient population that could benefit from Rezzayo. Thanks.

Joseph Todisco

Thanks, Serge. Look, on the new LDO, I really can't speak to the motivations of the company. Obviously, we have built a wealth of real-world evidence around the clinical efficacy and the pharmacoeconomic benefits of DefenCath, and as I said, we're happy that now they are choosing to begin implementation of DefenCath. On Rezzayo, look, it's going to be a label review issue. So until we work through this process, just coming out of the pre-NDA meeting, we don't have yet visibility of what the final label will be.

Operator

Our next question comes from Brandon Folkes with H.C. Wainwright. Please go ahead.

Brandon Folkes

Hi, thanks for taking my question and congrats on the progress. Maybe just 1 from me. Can you just talk about the SG&A in the quarter and the updated guidance? Did you take any actions in the quarter, you know, whether it's especially on the sales and marketing infrastructure, right, just on DefenCath or the existing Melinta portfolio, just any color there on the expense discipline on the SG&A line. Thank you.

Joseph Todisco

Thanks, Brandon. I'll let Susan comment. We didn't take any deliberate actions. We're obviously trending a little bit light on the expense side. Some of the staffing, some of that we're bringing on or is coming in later in the year. But, yes.

Susan Blum

Also, we did, and we disclosed this in our Form 10-Q, we had a reduction of G&A for $4.2 million in the quarter. It's reflecting artificially low because of that. $2.7 million of that was incurred primarily in Q1 of 2026. So we added the deductible under our insurance policies for the litigation costs. So we were able to claim the reimbursement of those, and that's what we reported in the second quarter. So it essentially eliminated those litigation legal fees that we had incurred in Q1 and in Q2 during the second quarter. So if you think about the run rate for expenses it would be maybe it would be $2.7 million higher because of what we reversed from prior periods.

Brandon Folkes

That makes sense. It does. And then just to confirm, so, you know, there's been no action from the Department of Health on the DefenCath sales and marketing infrastructure ahead of sort of the lower re-embedding period? No, there have been no actions taken in the company. Perfect. Thank you very much and congrats on the progress. Thank you.

Operator

This concludes our question and answer session. Thank you for attending today's presentation. You may now disconnect.

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