코메딕스(CRMD) 2026년 2분기 실적발표: 매출 1억 190만 달러 기록, EBITDA 가이던스 상향

주요 핵심 요약

• 코메디엑스(CorMedix)는 2026년 2분기 연결 매출이 1억 1,90만 달러로, 2025년 2분기의 3,970만 달러에서 증가했다고 발표했습니다. 디펜캐스(DefenCath)가 6,610만 달러를 기여했으며, 인수한 멜린타(Melinta) 포트폴리오가 3,580만 달러를 기여했습니다.
• 조정 EBITDA는 전년 동기의 2,240만 달러에서 5,870만 달러로 증가했습니다. 순이익은 2,600만 달러로, 기본주당순이익(EPS)은 0.33달러, 희석주당순이익은 0.29달러를 기록했습니다.
• 회사는 2026년 전체 매출 가이던스를 3억 2,500만 달러~3억 4,500만 달러로 재확인했으며, 조정 EBITDA 가이던스는 1억 2,500만 달러~1억 4,000만 달러로 상향 조정했습니다.
• 코메디엑스는 또 다른 대형 투석 기관과 디펜캐스 다년 공급 계약을 체결하여 미국 5대 투석 제공업체 모두를 커버하게 되었습니다. 약 수백 개의 클리닉이 참여하는 시범 프로그램이 2026년 3분기에 시작될 예정입니다.
• 침습성 진균 질환 예방을 위한 레짜요(Rezzayo)의 임상 3상 ReSPECT 연구가 FDA의 1차 평가변수를 충족했습니다. 코메디엑스와 문디파마(Mundipharma)는 2026년 3분기로 예정된 적응증 추가 승인 신청(sNDA) 제출을 지원하고 있습니다.
• 분기 말 기준 현금 및 현금성 자산은 총 2억 5,670만 달러였으며, 2026년 상반기 영업활동 현금흐름은 1억 2,860만 달러에 달했습니다.

핵심 재무 실적

사업 및 영업 성과

디펜캐스 및 TDAPA 종료 후 전환

코메디엑스는 7월 디펜캐스 주문량이 2026년 가이던스의 기반이 된 TDAPA 종료 후 가정과 일치했다고 밝혔습니다. 대형 투석 제공업체 간 주문량은 안정화된 반면, 소형 제공업체에서는 일부 감소세를 보였으며, 이는 모두 경영진의 예상과 일치했습니다.

이번 신규 다년 계약으로 코메디엑스는 미국 5대 투석 제공업체 모두와 상업적 공급 계약을 체결하게 되었습니다. 신규 고객사는 초기 주문을 완료했으며 2026년 3분기에 시범 프로그램을 시작할 계획입니다. 경영진은 이 시범 프로그램에 수백 개의 클리닉이 참여할 수 있으며, 2027년에는 사용 확대 가능성이 있다고 추정했습니다.

코메디엑스는 또한 주요 고객사들과의 계약을 수정하여 2026년 3분기 및 4분기 가격 책정을 반영했습니다. 일부 수정안에는 2027년 가격 및 물량 약정이 포함되어 있어 환급 전환기 동안의 가시성을 개선했습니다.

메디케어 어드밴티지(Medicare Advantage) 계약 체결은 장기적인 성장 중점 분야로 남아 있습니다. 경영진은 논의가 진행 중이지만 계약 주기 기간이 길어질 수 있다고 지적했습니다. 회사의 2026년 가이던스에는 메디케어 어드밴티지의 기여분이 포함되어 있지 않습니다.

4분기 미국신장학회(ASN) 키드니 위크 및 IDWeek에서 디펜캐스의 추가적인 실사용 근거(RWE)가 발표될 예정입니다. 발표 계획에는 U.S. Renal Care 연구의 최종 결과와 클로르헥시딘 항균 캡을 사용한 디펜캐스 연구, 그리고 tPA 사용 감소와 관련된 임상적 및 경제적 잠재적 이점이 포함됩니다.

레짜요 예방 프로그램

임상 3상 ReSPECT 연구는 90일 시점의 진균 미감염 생존율이라는 FDA 1차 평가변수를 충족하여 사전 설정된 오차 범위 내에서 표준 항진균제 요법 대비 비열등성을 입증했습니다. 경영진은 또한 투여량 변경, 중단 또는 연구 중단으로 이어진 치료 후 발생 이상사례(TEAE)를 포함하여 2차 안전성 평가변수 전반에서 우수한 특성을 보였다고 언급했습니다.

FDA와의 사전 NDA 미팅에 이어, 코메디엑스는 2026년 3분기 중 침습성 진균 질환 예방을 위한 레짜요의 적응증 추가 승인 신청(sNDA) 제출을 지원하기 위해 문디파마와 협력하고 있습니다. 추가 임상 3상 데이터는 2026년 4분기 하나 이상의 의학 학술대회에서 발표될 예정입니다.

문디파마는 현재 미국 NDA 소유권을 보유하고 있습니다. 양사의 계약에 따라 예방 적응증에 대한 sNDA 승인 후 소유권이 코메디엑스로 이전됩니다.

디펜캐스 TPN 연구

코메디엑스는 특정 제외 기준을 축소하기 위해 프로토콜 개정안을 제출했으며, 임상 3상 전정맥영양(TPN) 연구를 위한 추가 임상시험 기관을 활성화했습니다. 경영진은 2028년에 연구가 완료될 것으로 계속 예상하고 있습니다.

경영진 가이던스

경영진은 디펜캐스 매출이 연간 매출 전망 범위의 중간에서 상단 수치를 향해 순조롭게 진행 중이라고 밝혔습니다. 회사는 TDAPA 종료 후 주문 패턴에 대한 가시성이 더 확보됨에 따라 가이던스를 재검토할 계획입니다.

레짜요의 잠재적 승인과 관련된 투자 계획에는 약 15~20개의 추가 상업 및 의학 관련 직무 신설이 포함되어 있습니다. 이러한 비용은 현금 영업 비용 가이던스에 이미 반영되어 있습니다.

리스크 및 주요 관전 포인트

• TDAPA 종료 후 주문에 대한 가시성은 특히 소형 투석 제공업체 사이에서 여전히 제한적입니다.
• 신규 계약을 체결한 대형 투석 기관의 확장 시기와 규모는 초기 시범 프로그램 결과에 달려 있습니다.
• 메디케어 어드밴티지 계약 주기는 길며, 경영진은 2026년 가이던스에 관련 기여분이 없다고 가정했습니다.
• 최종 ESRD 환급 규정은 실적 발표 통화에서 논의된 제안된 분기별 메커니즘과 다를 수 있습니다.
• 레짜요의 최종 예방 적응증 라벨은 FDA의 검토 대상이며, 경영진은 아직 최종 범위에 대한 가시성을 확보하지 못했습니다.
• 레짜요 제출 및 규제 일정은 적시 제출 및 FDA 접수 여부에 달려 있습니다.

애널리스트 Q&A 주요 내용

• 신규 투석 제공업체 시범 프로그램: 경영진은 초기 디펜캐스 시범 프로그램이 수백 개의 클리닉을 커버할 수 있을 것으로 추정했으나, 2027년의 잠재적 영향을 수치화하기에는 아직 이르다고 밝혔습니다.
• 당해 분기 물량: 7월 물량은 대형 제공업체 사이에서 안정적이었던 반면, 소형 고객사에서는 일부 감소가 나타났습니다. 경영진은 보다 광범위한 채택과 메디케어 어드밴티지 계약 체결을 주요 물량 성장 동력으로 꼽았습니다.
• 레짜요 시장 반응: 코메디엑스는 전체 임상 3상 데이터 세트가 아직 출간되지 않았기 때문에 광범위한 시장 조사를 수행하지 않았습니다. 2026년 4분기에 더 많은 데이터가 공개될 예정입니다.
• 영업 비용 런레이트: 경영진은 의도적인 비용 절감 조치를 취하지 않았다고 밝혔습니다. 2분기 일반관리비(G&A)는 주로 2026년 1분기에 발생한 법률 비용과 관련된 270만 달러를 포함해 420만 달러의 보험 상환 크레딧으로 인해 감소했습니다.
• 상업 인프라: 경영진은 TDAPA 종료 후 환급 기간에 앞서 디펜캐스의 판매 및 마케팅 인프라를 줄이기 위한 어떠한 조치도 취하지 않았음을 확인했습니다.

실적 발표 콘퍼런스 콜 전문

전체 실적 발표 컨퍼런스 콜 녹취록

경영진 발표

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.

질의응답

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.