CorMedix (CRMD) 2026年第二季法說會：營收達1.019億美元，上調EBITDA指引

重點摘要

• CorMedix 公布 2026 年第二季合併營收為 1.019 億美元，高於 2025 年第二季的 3,970 萬美元。DefenCath 貢獻了 6,610 萬美元，而收購的 Melinta 產品組合則貢獻了 3,580 萬美元。
• 調整後 EBITDA 從去年的 2,240 萬美元增加至 5,870 萬美元。淨利為 2,600 萬美元，或基本每股盈餘 0.33 美元、稀釋每股盈餘 0.29 美元。
• 公司重申 2026 全年營收指引為 3.25 億至 3.45 億美元，並將調整後 EBITDA 指引上調至 1.25 億至 1.4 億美元。
• CorMedix 與另一家大型洗腎機構簽署了 DefenCath 的多年供應協議，使其涵蓋範圍拓展至美國前五大洗腎服務提供商。預計將於 2026 年第三季啟動涵蓋估計數百家診所的試點計畫。
• 用於預防侵入性真菌疾病的 Rezzayo 第三期 ReSPECT 研究達到 FDA 主要終點。CorMedix 與 Mundipharma 正全力支援預計於 2026 年第三季遞交的新藥補充申請 (sNDA)。
• 截至季末，現金及現金等價物總計為 2.567 億美元，而 2026 年前六個月的營運現金流達到 1.286 億美元。

核心財務結果

業務與營運表現

DefenCath 與 TDAPA 後過渡期

CorMedix 表示，7 月 DefenCath 的訂單量符合其 2026 年指引所依據的 TDAPA 後假設。大型洗腎服務提供商的訂購量已趨於穩定，而較小型提供商則出現一些流失，兩者均符合管理層的預期。

這項新的多年期協議意味著 CorMedix 目前已與美國所有前五大洗腎服務提供商達成商業供應安排。最新客戶已下達初始訂單，並計劃於 2026 年第三季啟動試點。管理層估計該試點可能涵蓋數百家診所，並有機會在 2027 年擴大使用規模。

CorMedix 還修改了與主要客戶的合約，以涵蓋 2026 年第三季和第四季的定價。部分修訂內容包含 2027 年的定價與採購量承諾，從而提高了在給付過渡期間的可見度。

聯邦醫療保險優勢方案 (Medicare Advantage) 合約仍是長期的成長焦點。管理層表示討論正在推進中，但指出簽約週期可能較長。公司的 2026 年指引未計入 Medicare Advantage 的任何貢獻。

預計將於第四季的美國腎臟學會腎臟週 (ASN Kidney Week) 和 IDWeek 上發表更多 DefenCath 的真實世界證據。預計簡報的內容包括 U.S. Renal Care 研究的最終結果，以及探討 DefenCath 搭配氯己定 (chlorhexidine) 抗菌帽，以及其因減少 tPA 使用而帶來的潛在臨床與經濟效益的外部研究。

Rezzayo 預防計畫

第三期 ReSPECT 研究達到了 FDA 規定的第 90 天無真菌存活率主要終點，證明在預先設定的邊界內不劣於標準抗真菌療法。管理層還提到次要安全性終點表現良好，包括導致劑量調整、撤回或終止研究的治療期間不良事件。

在與 FDA 舉行 sNDA 前會議後，CorMedix 正與 Mundipharma 合作，以支援在 2026 年第三季提交 Rezzayo 用於預防侵入性真菌疾病的補充新藥申請 (sNDA)。預計將於 2026 年第四季的一場或多場醫學會議上展示更多第三期數據。

Mundipharma 目前擁有美國 NDA。根據兩家公司的協議，在預防適應症的補充新藥申請 (sNDA) 獲批後，所有權將轉移給 CorMedix。

DefenCath TPN 研究

CorMedix 遞交了方案修訂案，以縮窄某些排除條件，並為其全靜脈營養 (TPN) 第三期研究啟動了更多試驗中心。管理層仍預計該研究將於 2028 年完成。

管理層指引

管理層表示，DefenCath 的表現朝向全年營收範圍的中上區間邁進。隨著對 TDAPA 後訂購模式的能見度提高，公司計劃重新檢視指引。

與 Rezzayo 潛在獲批相關的計畫投資包括預計增加 15 至 20 個商業及醫療職位。這些成本已反映在現金營業費用指引中。

風險與關鍵觀察點

• 對 TDAPA 後訂購情況的可見度仍然有限，尤其是在較小型洗腎服務提供商方面。
• 新簽約的大型洗腎機構擴大採購的時間與規模，將取決於其初始試點計畫的結果。
• Medicare Advantage 簽約週期較長，且管理層在 2026 年指引中假設未有相關貢獻。
• 最終的 ESRD (末期腎臟病) 給付規則可能與電話會議中討論的提議季度機制有所不同。
• Rezzayo 最終的預防適應症標籤仍需經 FDA 審查，管理層目前尚無法預知其最終範圍。
• Rezzayo 的送件與監管審查時程取決於及時提交以及 FDA 的受理。

分析師問答亮點

• 新洗腎服務提供商試點計畫：管理層估計初始 DefenCath 試點計畫可能涵蓋數百家診所，但表示要量化對 2027 年的潛在影響還為時過早。
• 當季銷售量：7 月份較大型服務提供商的銷售量維持穩定，而較小型客戶則有所流失。管理層將更廣泛的採用與 Medicare Advantage 簽約視為銷售量成長的主要槓桿。
• Rezzayo 市場回饋：由於完整的第三期數據集尚未公開，CorMedix 尚未進行廣泛的市場研究。預計將於 2026 年第四季獲得更多數據。
• 營業費用年化率：管理層表示並未採取刻意的成本削減行動。第二季 G&A 費用因 420 萬美元的保險給付折抵而減少，其中包括主要與 2026 年第一季產生的法律費用相關的 270 萬美元。
• 商業化基礎設施：管理層確認在 TDAPA 後給付期到來之前，並未採取任何削減 DefenCath 銷售與行銷基礎設施的行動。

電話會議完整逐字稿

完整財報電話會議逐字稿

管理層陳述

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.

分析師問答

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.