Q2 2026 CorMedix Inc Earnings Call
Speaker #1: 6th century to France, and I told that fantastically to just call her when we're done so she can be part of whatever debrief.
Elizabeth Hurlburt: I told Beth that if we could just call her when we're done so she can be part of whatever debrief.
Speaker #2: Good morning, and welcome to the CorMedix second quarter 2026 earnings and corporate update conference call. Today's conference call is being recorded. There will be a question and answer session at the end of today's presentation, and instructions on how to ask a question will be given at that time.
Operator: Good morning, and welcome to the CorMedix second quarter 2026 earnings and corporate update conference call. Today's conference call is being recorded. There will be a question and answer session at the end of today's presentation, and instructions on how to ask a question will be given at that time. At this time, I would like to turn the conference call over to Dan Ferry from LifeSci Advisors. Please go ahead.
Operator: Good morning, and welcome to the CorMedix Q2 2026 earnings and corporate update conference call. Today's conference call is being recorded. There will be a question and answer session at the end of today's presentation, and instructions on how to ask a question will be given at that time. At this time, I would like to turn the conference call over to Dan Ferry from LifeSci Advisors. Please go ahead.
Speaker #2: At this time, I would like to turn the conference call over to Dan Ferry from LifeSci Advisors. Please go ahead.
Speaker #3: Good morning, and welcome to the CorMedix second quarter 2026 earnings and corporate update conference call. Leading the call today is Joe Todisco, Chairman and Chief Executive Officer of CorMedix.
Dan 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. He is joined by Elizabeth 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 by the company's prospects and future financial position.
Dan 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. He is joined by Elizabeth 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 by the company's prospects and future financial position.
Speaker #3: Needed joined by Liz Hurlbert, EVP and Chief Operating and Commercial, Chief excuse me, Commercial Officer, and Susan Blum, EVP and Chief Financial Officer. In addition, Beth Zelnikoffen, 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.
Speaker #3: 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 meeting set forth in the private securities litigation reform act of 1995.
Speaker #3: These statements are statements other than statements of historical fact regarding management's expectations, beliefs, goals, and plans by the company's prospects, and future financial position.
Speaker #3: Action 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.
Dan Ferry: 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, and investors 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 measures of its performance. GAAP to non-GAAP financial reconciliations and supplemental financial information are provided in CorMedix's earnings release and the current report on Form 8-K filed with the SEC. This information is also available on the investor relations section of CorMedix's website.
Dan Ferry: 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, and investors 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 measures of its performance. GAAP to non-GAAP financial reconciliations and supplemental financial information are provided in CorMedix's earnings release and the current report on Form 8-K filed with the SEC. This information is also available on the investor relations section of CorMedix's website.
Speaker #3: These 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, and investors should not place undue reliance on these statements. CorMedix does not intend to update these forward-looking statements except as required by law.
Speaker #3: During this call, the company will discuss certain non-GAAP measures of its performance, GAAP to non-GAAP financial reconciliations and supplemental financial information are provided in CorMedix earnings release and the current report on Form 8K filed with the SEC.
Speaker #3: This information is also available on the investor relations section of CorMedix website. At this time, it is now my pleasure to turn the call over to Joe Todisco Chairman and Chief Executive Officer of CorMedix.
Dan Ferry: 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.
Dan Ferry: 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.
Speaker #3: Joe, please go ahead.
Speaker #4: Thank you, Dan. Good morning, everyone, and thank you for joining us on this call. In the second quarter, we continued to execute on our core strategic initiatives.
Joseph Todisco: Thank you, Dan. Good morning, everyone, and thank you for joining us on this call. In the Q2, we continued to execute on our core strategic initiatives: solidifying DefenCath's market position as we navigate the evolving post-TDAPA landscape, meaningfully advancing our high-value pipeline, highlighted by the positive phase III 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. Lastly, deploying our capital in a disciplined manner to fuel sustainable growth and new business development opportunities. We believe this combination of commercial execution, pipeline progression, and strategic capital allocation positions CorMedix to drive long-term value for shareholders while building an increasingly diversified and resilient business. We announced this morning Q2 consolidated revenue of $101.9 million and adjusted EBITDA of $58.7 million. Susan will provide more granular details of Q2 financial results.
Joe Todisco: Thank you, Dan. Good morning, everyone, and thank you for joining us on this call. In the Q2, we continued to execute on our core strategic initiatives: solidifying DefenCath's market position as we navigate the evolving post-TDAPA landscape, meaningfully advancing our high-value pipeline, highlighted by the positive phase III 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. Lastly, deploying our capital in a disciplined manner to fuel sustainable growth and new business development opportunities. We believe this combination of commercial execution, pipeline progression, and strategic capital allocation positions CorMedix to drive long-term value for shareholders while building an increasingly diversified and resilient business. We announced this morning Q2 consolidated revenue of $101.9 million and adjusted EBITDA of $58.7 million. Susan will provide more granular details of Q2 financial results.
Speaker #4: Solidifying DefendCat's market position as we navigate the evolving posted Apple landscape, meaningfully advancing our high-value pipeline, highlighted by the positive phase three respect data for Rosio, and now working collaboratively with Mundipharma towards their submission of the SMDA for Rosio in the prophylaxis of invasive fungal disease.
Speaker #4: And lastly, deploying our capital in a disciplined manner to fuel sustainable growth and new business development opportunities. We believe this combination of commercial execution, pipeline progression, and strategic capital allocation positions CorMedix to drive long-term value for shareholders.
Speaker #4: 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.
Speaker #4: Susan will provide more granular details of second quarter financial results. Today, we also announced that we have signed a multi-year commercial supply agreement for DefendCat with an additional large dialysis organization, or LDO.
Joseph Todisco: Today, we also announced that we have 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 five of the top dialysis providers in the US. The newly signed LDO has placed initial order and will initially begin a pilot of DefenCath in the Q3 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 US 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.
Joe Todisco: Today, we also announced that we have 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 five of the top dialysis providers in the US. The newly signed LDO has placed initial order and will initially begin a pilot of DefenCath in the Q3 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 US dialysis market. Turning to guidance, we are reaffirming our full year 2026 revenue guidance with a range of $325 to 345 million and raising our full year adjusted EBITDA guidance to a new range of $125 to 140 million.
Speaker #4: With this agreement, CorMedix now has commercial supply agreements in place with all five of the top dialysis providers in the U.S. The newly signed LDO has placed an initial order and will begin a pilot of DefenCath in the third quarter of this year, with a potential opportunity to expand utilization in 2027.
Speaker #4: Review the signing of this agreement as an important milestone and validation of DefendCat's clinical value proposition with the largest providers in the US dialysis market.
Speaker #4: 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 to $140 million.
Speaker #4: We will revisit guidance as the year progresses and as we gain additional visibility into posted APA ordering patterns. While we're only a few weeks into the third quarter, DefenCath's order volumes in July have tracked consistent with the posted APA forecast underlying our financial guidance.
Joseph Todisco: We will revisit guidance as the year progresses and as we gain additional visibility into post-TDAPA ordering patterns. While we are only a few weeks into the Q3, 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 Q3 and Q4 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 DefenCath's growth strategy through Medicare Advantage contracting, and I am pleased with the progress of those discussions to date. Contracting cycles with these plans can be lengthy, and we have not assumed a contribution from Medicare Advantage in our 2026 guidance.
Joe Todisco: We will revisit guidance as the year progresses and as we gain additional visibility into post-TDAPA ordering patterns. While we are only a few weeks into the Q3, 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 Q3 and Q4 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 DefenCath's growth strategy through Medicare Advantage contracting, and I am pleased with the progress of those discussions to date. Contracting cycles with these plans can be lengthy, and we have not assumed a contribution from Medicare Advantage in our 2026 guidance.
Speaker #4: In addition to the new LDO agreement, we have signed contract amendments with our major customers covering third and fourth Turning to guidance, we quarter 2026 pricing and in some instances pricing and volume commitments for 2027.
Speaker #4: 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 DefendCat's growth strategy through Medicare Advantage contracting, and I'm pleased with the progress of those discussions to date.
Speaker #4: Contracting cycles with these plans can be lengthy, and we have not assumed a contribution from Medicare Advantage in our 2026 guidance. We continue to believe Medicare Advantage represents a meaningful long-term growth avenue for DefendCat.
Joseph Todisco: We continue to believe 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 announced this morning that we anticipate the submission of the sNDA for REZZAYO in prophylaxis in the Q3 of this year. This follows last quarter's announcement of positive preliminary top-line clinical trial results from the ReSPECT study, a phase III clinical study evaluating REZZAYO for the prophylaxis of invasive fungal disease in adult immunosuppressed patients undergoing allogeneic bone and marrow transplant.
Joe Todisco: We continue to believe 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 announced this morning that we anticipate the submission of the sNDA for REZZAYO in prophylaxis in the Q3 of this year. This follows last quarter's announcement of positive preliminary top-line clinical trial results from the ReSPECT study, a phase III clinical study evaluating REZZAYO for the prophylaxis of invasive fungal disease in adult immunosuppressed patients undergoing allogeneic bone and marrow transplant.
Speaker #4: DefendCat'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 ID Week.
Speaker #4: Turning to our pipeline, we announced this morning that we anticipate the submission of the SMDA for Rosio in prophylaxis in the third quarter of this year.
Speaker #4: This follows last quarter's announcement of positive preliminary top-line clinical trial results from the RESPECT study, a Phase 3 clinical study evaluating Rosio for the prophylaxis of invasive fungal disease in adult immunosuppressed patients undergoing allogeneic bone and marrow transplant.
Speaker #4: We believe these results position Rosio, if approved, to become an attractive option for clinicians in the prophylaxis of invasive fungal disease or IFD. Assuming timely submission and FDA acceptance of the filing, we would anticipate agency action in the first half of 2027.
Joseph Todisco: We believe these results position REZZAYO, if approved, to become an attractive option for clinicians in the prophylaxis of invasive fungal disease or IFD. Assuming timely submission and FDA acceptance of the filing, we would anticipate agency action in the H1 of 2027. As we begin to prepare our commercial infrastructure for a potential launch of REZZAYO for prophylaxis, we expect to incur incremental spend in the back 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 to $155 million. As a reminder, our cash OPEX guidance excludes non-cash charges such as stock-based compensation.
Joe Todisco: We believe these results position REZZAYO, if approved, to become an attractive option for clinicians in the prophylaxis of invasive fungal disease or IFD. Assuming timely submission and FDA acceptance of the filing, we would anticipate agency action in the H1 of 2027. As we begin to prepare our commercial infrastructure for a potential launch of REZZAYO for prophylaxis, we expect to incur incremental spend in the back 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 to 155 million. As a reminder, our cash OPEX guidance excludes non-cash charges such as stock-based compensation.
Speaker #4: As we begin to prepare our commercial infrastructure for potential launch of Rosio for prophylaxis, we expect to incur incremental spend in the back half of the year, including the anticipated addition of 15 to 20 positions across both commercial and medical.
Speaker #4: These investments are sized to allow us to move quickly in approval while preserving flexibility of regulatory timeline shift and are already reflected in our narrowed full year cash op x guidance of $145 to $155 million.
Speaker #4: As a reminder, our cash operating expense guidance excludes non-cash charges such as stock-based compensation. I would now like to turn the call over to our Chief Operating Commercial Officer, Liz Herlbert, to provide an update on clinical activities.
Joseph Todisco: I would now like to turn the call over to our Chief Operating Commercial Officer, Elizabeth Hurlburt, to provide an update on clinical activities. Liz, please go ahead.
Joe Todisco: I would now like to turn the call over to our Chief Operating Commercial Officer, Elizabeth Hurlburt, to provide an update on clinical activities. Liz, please go ahead.
Speaker #4: Liz, please go ahead.
Speaker #5: 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, our working diligently with our partner Mundipharma in support of their submission of the FNDA for Rosio in prophylaxis in the third quarter.
Elizabeth 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. Following a constructive pre-NDA meeting with the FDA, we are working diligently with our partner, Mundipharma, in support of their submission of the sNDA for REZZAYO in prophylaxis in Q3. 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 the treatment of emergent adverse events leading to dose reduction, interruption, or withdrawal of study drug and study discontinuation.
Liz 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. Following a constructive pre-NDA meeting with the FDA, we are working diligently with our partner, Mundipharma, in support of their submission of the sNDA for REZZAYO in prophylaxis in Q3. 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 the treatment of emergent adverse events leading to dose reduction, interruption, or withdrawal of study drug and study discontinuation.
Speaker #5: 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.
Speaker #5: In addition, results showed a favorable profile across multiple secondary endpoints, most notably in the treatment of emergent treatment emergent adverse events leading to dose reduction, interruption or withdrawal of study drugs, and study discontinuation.
Speaker #5: As we've 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.
Elizabeth Hurlburt: As we have 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 is 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 US 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 US asset.
Liz Hurlburt: As we have 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 is 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 US 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 US asset.
Speaker #5: We believe the study has achieved this objective, in that the results position Rosio, if approved, as a differentiated option for prophylaxis of IFD, with a meaningful potential commercial opportunity.
Speaker #5: 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.
Speaker #5: Mundipharma is currently the holder of the US NDA and, under the terms of our agreement, transfers ownership of the NDA to CorMedix following approval of an FNDA for the prophylaxis indications.
Speaker #5: At that point, CorMedix would own and control the US assets. Under our agreement, the parties must work together on the publication of data and any submissions to the FDA.
Elizabeth Hurlburt: Under our agreement, the parties must work together on the publication of data and any submissions to FDA. In terms of data publication, we currently expect additional data from the phase III ReSPECT Study to be published later this year at one or more medical conferences during Q4. Turning to DefenCath, we also expect additional real-world evidence to be published in Q4, 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 two other external studies.
Liz Hurlburt: Under our agreement, the parties must work together on the publication of data and any submissions to FDA. In terms of data publication, we currently expect additional data from the phase III ReSPECT Study to be published later this year at one or more medical conferences during Q4. Turning to DefenCath, we also expect additional real-world evidence to be published in Q4, 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 two other external studies.
Speaker #5: In terms of data publication, we currently expect additional data from the phase three respect study to be published later this year at one or more medical conferences during the fourth quarter.
Speaker #5: Turning to DefendCat, we also expect additional real-world evidence to be published in the fourth quarter with multiple abstracts having been submitted to both ASN and ID Week.
Speaker #5: Assuming acceptance, these publications will present the final results from the US 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 two other external studies.
Speaker #5: The first will highlight the demonstrated efficacy of DefendCat when used in combination with chlorhexidine antimicrobial caps. The second is expected to highlight the clinical and economic benefits of DefendCat in the outpatient hemodialysis setting, related to a meaningful reduction in TPA use by facilities.
Elizabeth Hurlburt: The first will highlight the demonstrated efficacy of DefenCath when used in combination with chlorhexidine antimicrobial caps, and 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 III 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.
Liz Hurlburt: The first will highlight the demonstrated efficacy of DefenCath when used in combination with chlorhexidine antimicrobial caps, and 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 III 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.
Speaker #5: All combined, we expect that these data will add to the growing body of evidence supporting the clinical and pharmacoeconomic value of DefendCat. Shifting gears to our phase three 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.
Speaker #5: 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.
Speaker #5: I would now like to turn the call over to Susan to discuss the company's second quarter financial results and financial position. Susan?
Elizabeth Hurlburt: I would now like to turn the call over to Susan to discuss the company's Q2 financial results and financial position. Susan?
Liz Hurlburt: I would now like to turn the call over to Susan to discuss the company's Q2 financial results and financial position. Susan?
Speaker #6: Thanks, Liz, and good morning, everyone. We are pleased to announce our second-quarter results, which reflect strong execution across the business, continued demand for DefendCat, and the contribution from the acquired Melinta portfolio.
Susan Blum: Thanks, Liz, and good morning, everyone. We are pleased to announce our Q2 results, which reflect strong execution across the business, continued demand for DefenCath, and a contribution from the acquired Melinta portfolio. As a reminder, because the Melinta acquisition closed in August 2025, Q2 2026 includes a full quarter of Melinta operations, while Q2 2025 does 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, Q2 2026 consolidated revenue was $101.9 million, compared with $39.7 million in Q2 2025. Q2 revenue included $66.1 million in sales of DefenCath and $35.8 million in revenue associated with the acquired Melinta portfolio.
Susan Blum: Thanks, Liz, and good morning, everyone. We are pleased to announce our Q2 results, which reflect strong execution across the business, continued demand for DefenCath, and a contribution from the acquired Melinta portfolio. As a reminder, because the Melinta acquisition closed in August 2025, Q2 2026 includes a full quarter of Melinta operations, while Q2 2025 does 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, Q2 2026 consolidated revenue was $101.9 million, compared with $39.7 million in Q2 2025. Q2 revenue included $66.1 million in sales of DefenCath and $35.8 million in revenue associated with the acquired Melinta portfolio.
Speaker #6: As a reminder, because the Melinda acquisition closed in August 2025, the second quarter of 2026 includes a full quarter of Melinda operations. While the second quarter of 2025 does not.
Speaker #6: 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.
Speaker #6: 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 DefendCat and $35.8 million in revenue associated with the acquired Melinda portfolio.
Speaker #6: DefendCat 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%.
Susan Blum: 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 Q2 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 Q2 2026, compared with $2.4 million for the same period in 2025.
Susan Blum: 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 Q2 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 Q2 2026, compared with $2.4 million for the same period in 2025.
Speaker #6: The increase of $15.9 million over the prior year period was driven primarily by the contribution of operating expenses from the Melinda acquisition for the full quarter and reflects the larger combined company.
Speaker #6: 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 brands, and continued investment in the development of DefendCat for the TPN indication.
Susan Blum: The increase was due primarily to higher personnel and clinical trial services in support of ongoing clinical programs, including pediatric studies for several brands and continued investment in the development of DefenCath for the TPN indication. Selling and marketing expense increased approximately 95% to $12.4 million in Q2 2026, from $6.4 million in Q2 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 Q2 2026, from $9.5 million in Q2 2025. The increase was driven by higher costs associated with operating as a combined company following the acquisition, including branded prescription drug fees and higher personnel, information technology, legal, and facilities costs.
Susan Blum: The increase was due primarily to higher personnel and clinical trial services in support of ongoing clinical programs, including pediatric studies for several brands and continued investment in the development of DefenCath for the TPN indication. Selling and marketing expense increased approximately 95% to $12.4 million in Q2 2026, from $6.4 million in Q2 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 Q2 2026, from $9.5 million in Q2 2025. The increase was driven by higher costs associated with operating as a combined company following the acquisition, including branded prescription drug fees and higher personnel, information technology, legal, and facilities costs.
Speaker #6: Selling 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.
Speaker #6: 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.
Speaker #6: The increase was driven by higher costs associated with operating as a combined company following the acquisition, including branded prescription drug fees and higher personnel, information technology, legal, and facilities costs.
Speaker #6: G&A expenses in the quarter also reflect 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.
Susan Blum: G&A expenses in the quarter also reflect 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 recorded in Q2, $2.7 million 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 Q2 2026, compared with net income of $19.8 million or $0.29 and $0.28 per basic and diluted share, respectively, in Q2 2025.
Susan Blum: G&A expenses in the quarter also reflect 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 recorded in Q2, $2.7 million 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 Q2 2026, compared with net income of $19.8 million or $0.29 and $0.28 per basic and diluted share, respectively, in Q2 2025.
Speaker #6: Of the $4.2 million credit recorded in the second quarter, $2.7 million related to legal fees that were incurred in prior periods. On the bottom line, CorMedix recorded net income of $26.0 million.
Speaker #6: Or $33.29 per basic and diluted share, respectively, in the second quarter of 2026, compared with net income of $19.8 million, or $29.28 per basic and diluted share, respectively, in the second quarter of 2025.
Speaker #6: 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 Melinda shareholders.
Susan Blum: 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 Q2 2026, compared with adjusted EBITDA of $22.4 million in Q2 2025. This adjusted EBITDA metric excludes non-cash items such as depreciation, amortization, stock-based compensation, interest and other income and expenses net, taxes, and certain non-recurring items. We ended Q2 with $256.7 million in cash and cash equivalents.
Susan Blum: 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 Q2 2026, compared with adjusted EBITDA of $22.4 million in Q2 2025. This adjusted EBITDA metric excludes non-cash items such as depreciation, amortization, stock-based compensation, interest and other income and expenses net, taxes, and certain non-recurring items. We ended Q2 with $256.7 million in cash and cash equivalents.
Speaker #6: 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.
Speaker #6: This adjusted EBITDA metric excludes non-cash items such as depreciation, amortization, stock-based compensation, interest in other income and expenses net, taxes, and certain non-recurring items.
Speaker #6: We ended the second quarter with $256.7 million in cash and cash equivalents. For the six months of 2026, net cash provided by operating activities was $128.6 million, compared with $49.7 million for the first six months of 2025.
Susan Blum: For the six months of 2026, net cash provided by operating activities was $128.6 million, compared with $49.7 million for the first six 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 creation. I will turn the call back to Joe for closing remarks. Joe?
Susan Blum: For the six months of 2026, net cash provided by operating activities was $128.6 million, compared with $49.7 million for the first six 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 to 345 million, full year DefenCath revenue guidance of $175 to 195 million, and revised full year adjusted EBITDA guidance of $125 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 creation. I will turn the call back to Joe for closing remarks. Joe?
Speaker #6: 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 DefendCat revenue guidance of $175 million to $195 million, and revised full year adjusted EBITDA guidance of $125 million to $140 million.
Speaker #6: 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 creation.
Speaker #6: And now I will turn the call back to Joe for closing remarks. Joe?
Speaker #1: Thank you, Susan. I'm confident in where the company stands today and the opportunity ahead of us. CorMedix has built meaningful momentum through the first half of 2026 across all three pillars of our investment thesis.
Joseph Todisco: Thank you, Susan. I am confident where the company stands today and in the opportunity ahead of us. CorMedix has built meaningful momentum through H1 2026 across all three 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 are 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. Third, we have delivered significant profitability and 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, which allows us to reinvest in growth and pursue business development opportunities.
Joe Todisco: Thank you, Susan. I am confident where the company stands today and in the opportunity ahead of us. CorMedix has built meaningful momentum through H1 2026 across all three 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 are 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. Third, we have delivered significant profitability and 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, which allows us to reinvest in growth and pursue business development opportunities.
Speaker #1: First, DefendCat continues to perform in line with our internal expectations as to DAPA expiration, demonstrating durable underlying utilization, which we believe positions the franchise to remain a meaningful value generator following the reimbursement transition.
Speaker #1: Second, we are advancing a pipeline of high-value late-stage opportunities, including Rizeva for prophylaxis and DefendCat and TPN. Which could meaningfully expand our long-term revenue opportunity.
Speaker #1: And third, we have delivered significant profitability and 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.
Speaker #1: This allows us to reinvest in growth and pursue business development opportunities. We remain confident in our outlook for this year, as well as our past sustained growth and profitability beyond it.
Joseph Todisco: We remain confident in our outlook for this year and our path to sustained growth and profitability beyond it. This concludes our prepared remarks. I'll ask the operator to open up now for questions.
Joe Todisco: We remain confident in our outlook for this year and our path to sustained growth and profitability beyond it. This concludes our prepared remarks. I'll ask the operator to open up now for questions.
Speaker #1: This concludes our prepared remarks, and I'll ask the operator to open up now for questions.
Speaker #2: We will now begin the question and answer session. To ask a question, you may press star then 1 on your touch-tone phone. If you are using a speakerphone, please pick up your handset before pressing the keys.
Operator: We will now begin the question and answer session. To ask a question, you may press star then one on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. Our first question comes from Roanna Ruiz with Leerink. Please go ahead.
Operator: We will now begin the question and answer session. To ask a question, you may press star then one on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. Our first question comes from Roanna Ruiz with Leerink. Please go ahead.
Speaker #2: If at any time your question has been addressed and you would like to withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster.
Speaker #2: Our first question comes from Roanna Ruiz with Lerank. Please go ahead.
Speaker #4: 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.
[Analyst] (Leerink): 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 the steady-state production in line with other operators. I have a follow-up.
[Analyst] (Leerink): 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 the steady-state production in line with other operators. I have a follow-up.
Speaker #4: 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.
Speaker #4: And I have a follow-up.
Speaker #1: Okay. Thanks, Anna. So we've 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.
Joseph Todisco: Okay. Thanks, Anna. We just recently signed that agreement, and they're rolling out a pilot. We're waiting to see actually what they're looking for, and we're hopeful for additional utilization. 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. 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.
Joe Todisco: Okay. Thanks, Anna. We just recently signed that agreement, and they're rolling out a pilot. We're waiting to see actually what they're looking for, and we're hopeful for additional utilization. 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. 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.
Speaker #1: 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 27 guidance.
Speaker #1: 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.
Speaker #1: 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.
Speaker #4: Sure. Thanks. And is any of that LDO pilot included in the 2026 guidance?
[Analyst] (Leerink): Sure, thanks. Is any of that LDO pilot included in the 2026 guidance?
[Analyst] (Leerink): Sure, thanks. Is any of that LDO pilot included in the 2026 guidance?
Speaker #1: No, no. Right now, it's—well, obviously, it's tracked in the revenue, so the revenue that we're seeing from the pilot is within our existing guidance.
Joseph Todisco: No. Right now, obviously, it is tracking the revenue, so the revenue that we are seeing from the pilot is within our existing guidance. For DefenCath, we are right now tracking to the mid-top part of the DefenCath guidance. Let us see where we go through the year, as I said, we will update as we go.
Joe Todisco: No. Right now, obviously, it is tracking the revenue, so the revenue that we are seeing from the pilot is within our existing guidance. For DefenCath, we are right now tracking to the mid-top part of the DefenCath guidance. Let us see where we go through the year, as I said, we will update as we go.
Speaker #1: And right, for DefendCat, we are right now tracking to the kind of mid-top part of the DefendCat guidance. So let's see where we go through the year and, as I said, we'll update as we go.
Speaker #4: Great. Thanks so much.
[Analyst] (Leerink): Great. Thanks so much.
[Analyst] (Leerink): Great. Thanks so much.
Speaker #2: Our next question comes from Leonid Temeshev with RBC Capital Markets. Please go ahead.
Operator: Our next question comes from Leonid Timashev with RBC Capital Markets. Please go ahead.
Operator: Our next question comes from Leonid Timashev with RBC Capital Markets. Please go ahead.
Speaker #5: Hey guys, thanks for taking my question. I wanted to ask if you can comment on what you're seeing in terms of volume growth in the existing channels thus far.
Leonid Timashev: Hey, guys. Thanks for taking my question. I want to ask, maybe if you can comment on what you are seeing in terms of volume growth in the existing channels thus far in this quarter, just given that we are in the post-TDAPA period now. Related to that, just as a follow-up, how are you thinking about the potential for the final ESRD guidance to increase the payment? Thanks.
Leonid Timashev: Hey, guys. Thanks for taking my question. I want to ask, maybe if you can comment on what you are seeing in terms of volume growth in the existing channels thus far in this quarter, just given that we are in the post-TDAPA period now. Related to that, just as a follow-up, how are you thinking about the potential for the final ESRD guidance to increase the payment? Thanks.
Speaker #5: In this quarter, just given that we're in the post-DAPA period now, and then related to that, just as a follow-up, how are you thinking about the potential for the final ESRD guidance to increase the payment?
Speaker #5: Thanks.
Speaker #1: All right. Thanks, Leo. 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.
Joseph Todisco: All right. Thanks, Leo. Look, in terms of volume growth, I think what we are 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. I think to really see volume growth in DefenCath, one of two things can happen. The new LDO is going to have to come in meaningfully with some adoption and/or Medicare Advantage contracting. I think we are cautiously optimistic we are making good progress that perhaps we have something in place that takes effect early next year and starts to really impact DefenCath volumes. Those are really the two levers that I see from a DefenCath standpoint. The final ESRD rule, obviously, they put out the proposed rule.
Joe Todisco: All right. Thanks, Leo. Look, in terms of volume growth, I think what we are 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. I think to really see volume growth in DefenCath, one of two things can happen. The new LDO is going to have to come in meaningfully with some adoption and/or Medicare Advantage contracting. I think we are cautiously optimistic we are making good progress that perhaps we have something in place that takes effect early next year and starts to really impact DefenCath volumes. Those are really the two levers that I see from a DefenCath standpoint. The final ESRD rule, obviously, they put out the proposed rule.
Speaker #1: Which is what we expected, and some attrition with the really small players, which is also what we expected. I think to really see volume growth in DefendCat one of two things is going to happen.
Speaker #1: The new LDO is going to have to come in meaningfully with some adoption and/or Medicare Advantage contracting. I think we're cautiously optimistic. We're making good progress.
Speaker #1: That, perhaps, we have something in place that takes effect early next year and starts to really impact DefenCath volumes. Those are really the two levers that I see from the DefenCath standpoint.
Speaker #1: 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.
Joseph Todisco: It was a little bit different than what we were expecting in terms of the quarterly mechanism. I expect there is going to be a lot of comment on that. Not sure if that is actually what will make it into the final rule. We will expect the final rule in November, and then we will adjust accordingly.
Joe Todisco: It was a little bit different than what we were expecting in terms of the quarterly mechanism. I expect there is going to be a lot of comment on that. Not sure if that is actually what will make it into the final rule. We will expect the final rule in November, and then we will adjust accordingly.
Speaker #1: I expect there's going to be a lot of comment on that. Not sure if that's what actually what will make it into the final rule, but we'll expect the final rule in November, and then we'll adjust accordingly.
Speaker #2: Our next question comes from Jason Butler with Citizens. Please go ahead.
Operator: Our next question comes from Jason Butler with Citizens. Please go ahead.
Operator: Our next question comes from Jason Butler with Citizens. Please go ahead.
Speaker #6: 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?
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? Then for REZZAYO and prophy, can you talk about, since you have the phase III results, the feedback you are getting from potential prescribers, just what the reception to that data has been as you think about a potential label expansion. Thank you.
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? Then for REZZAYO and prophy, can you talk about, since you have the phase III results, the feedback you are getting from potential prescribers, just what the reception to that data has been as you think about a potential label expansion. Thank you.
Speaker #6: And then for Rizeva, and Profi, can you talk about, since you have the phase three results, the feedback you're getting from potential prescribers? Just what the reception to that data has been as you think about a potential label expansion.
Speaker #6: Thank you.
Speaker #1: Yeah. Look, right now, the size and scope of the pilot, we've shipped an initial order. We think it's a couple hundred clinics. We'll see where we can go from there.
Joseph Todisco: Yeah. Look, right now, the size and scope of the pilot, we have shipped an initial order. We think it is a couple of hundred clinics. We will see where we can go from there. I do not want to get out over my skis on the pilot yet, Jason. So right now, we are really happy to have finally gotten that LDO over the hump and to the point of commercialization. So, we are taking that one day by day. On REZZAYO PROFI, the full data set is not yet out, so we really have not 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 Q4 at one or more medical conferences.
Joe Todisco: Yeah. Look, right now, the size and scope of the pilot, we have shipped an initial order. We think it is a couple of hundred clinics. We will see where we can go from there. I do not want to get out over my skis on the pilot yet, Jason. So right now, we are really happy to have finally gotten that LDO over the hump and to the point of commercialization. So, we are taking that one day by day. On REZZAYO PROFI, the full data set is not yet out, so we really have not 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 Q4 at one or more medical conferences.
Speaker #1: I don't want to get out over my skies on the pilot yet, Jason. So we're just right now, we're really happy to have finally gotten that LDO kind of over the hump and to the point of commercialization.
Speaker #1: So we're taking that one day by day. On Rizeva, Profi, the full data set is not yet out. So we really haven't been able to conduct a robust market research.
Speaker #1: As we said in the script, we are working with our partner Monday Pharma. We would expect it to be published later in the fourth quarter at one or more medical conferences.
Speaker #1: And once we have that data available, we'll be able to have more substantive discussions around the data itself with clinicians.
Joseph Todisco: Once we have that data available, we will be able to have more substantive discussions around the data itself with clinicians.</seg <seg id="3">Great. Thank you.
Joe Todisco: Once we have that data available, we will be able to have more substantive discussions around the data itself with clinicians.</seg <seg id="3">
Jason Butler: Great. Thank you.
Speaker #6: Great. Thank you.
Jason Butler: Great. Thank you.
Jason Butler: Great. Thank you.
Speaker #2: Our next question comes from Serge Balangé with Needham & Company. Please go ahead.
Operator: Our next question comes from Serge Belanger with Needham & Company. Please go ahead.
Operator: Our next question comes from Serge Belanger with Needham & Company. Please go ahead.
Speaker #7: Hi, good morning. Thanks for taking the question. First, on the new LDO—first, congratulations. Even though it's just a pilot program, my question is, why did the LDO decide to enter into an agreement now, when the product's been available for two years?
Serge Belanger: Hi, good morning. Thanks for taking the question. I guess first on the new LDO, first, congratulations, even if it's just a pilot program. I guess my question is why did the LDO decide to enter an agreement now when the product's 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 III 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.
Serge Belanger: Hi, good morning. Thanks for taking the question. I guess first on the new LDO, first, congratulations, even if it's just a pilot program. I guess my question is why did the LDO decide to enter an agreement now when the product's 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 III 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.
Speaker #7: And I know the company had some meaningful efforts to sign them up. Secondly, on Rizeva, following your FDA meeting, just curious what your expectations are for potential labeling of the product?
Speaker #7: I believe the phase three trial was conducted in allogeneic HSCT patients. Curious if you'll be able to address the broad patient population that could benefit from Rizeva.
Speaker #7: Thanks.
Speaker #1: Yeah, no, thanks, Serge. Look, on the new LDO, I really can't speak to the motivations of the company. In terms of timing, obviously, we have built a wealth of real-world evidence around the clinical efficacy and the pharmaco-economic benefits of DefenCath.
Joseph Todisco: Yeah. Thanks, Serge. Look, on the new LDO, I really can't speak to the motivations of the company in terms of timing. 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. Thanks.
Joe Todisco: Yeah. Thanks, Serge. Look, on the new LDO, I really can't speak to the motivations of the company in terms of timing. 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. Thanks.
Speaker #1: And as I said, we're happy that now, right, they are choosing to begin implementation of DefenCath. On Rezeva, look, it's going to be a label review issue.
Speaker #1: So, until we work through this process, we don't—just coming out of the pre-NDA meeting—we don't yet have visibility of what the final label will be.
Speaker #7: Thanks.
Speaker #2: Our next question comes from Brandon Folks with HC Wainwright. Please go ahead.
Operator: Our next question comes from Brandon Folks with H.C. Wainwright. Please go ahead.
Operator: Our next question comes from Brandon Folks with H.C. Wainwright. Please go ahead.
Speaker #5: All right. Thanks for taking my question, and congrats on the progress. Maybe just one from me. Can you just talk about the SG&A in the quarter and the updated guidance?
Brandon Folkes: Hi. Thanks for taking my question, and congrats on the progress. Maybe just one 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, especially on the sales and marketing infrastructure, just on DefenCath or the existing Melinta Therapeutics portfolio? Just any color there on the expense discipline on the SG&A line. Thank you.
Brandon Folkes: Hi. Thanks for taking my question, and congrats on the progress. Maybe just one 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, especially on the sales and marketing infrastructure, just on DefenCath or the existing Melinta Therapeutics portfolio? Just any color there on the expense discipline on the SG&A line. Thank you.
Speaker #5: Did you take any actions in the quarter? Whether it's especially on the sales and marketing infrastructure, right, just on DefendCat's or the existing Melinda portfolio, just any color there on the expense discipline on the SG&A line?
Speaker #5: Thank you.
Speaker #1: No, 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 that we're bringing on is coming in later in the year.
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 that we're bringing on is coming in later in the year, but
Joe 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 that we're bringing on is coming in later in the year, but
Speaker #1: But yeah.
Susan Blum: Yeah. 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. So it's reflecting artificially low because of that. $2.7 million of that was incurred primarily in Q1 of 2026. So we had hit 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 Q2. So it essentially eliminates those litigation legal fees that we had incurred in Q1 and in Q2 during the Q2. So if you think about the run rate for expenses, it would be maybe $2.7 million higher because of what we reversed from prior periods. Does that make sense?
Susan Blum: Yeah. 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. So it's reflecting artificially low because of that. $2.7 million of that was incurred primarily in Q1 of 2026. So we had hit 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 Q2. So it essentially eliminates those litigation legal fees that we had incurred in Q1 and in Q2 during the Q2. So if you think about the run rate for expenses, it would be maybe $2.7 million higher because of what we reversed from prior periods. Does that make sense?
Speaker #3: Yeah. And 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.
Speaker #3: So it's reflecting artificially low because of that. 2.7 million of that was incurred primarily in Q1 of 2026. So we edit the deductible under our insurance policies for the litigation costs.
Speaker #3: So we were able to claim the reimbursement of those, and that's what we recorded in the second quarter. So it essentially eliminates those litigation legal fees that we had incurred in Q1 and in Q2 during the second quarter.
Speaker #3: 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.
Speaker #3: Does that make sense?
Speaker #5: Thanks, it does. And then, just to confirm, there's been no actions taken on the DefendCat sales and marketing infrastructure ahead of the lower reimbursement period?
Brandon Folkes: It does. Then just to confirm, so there's been no actions taken on the DefenCath sales and marketing infrastructure ahead of the lower reimbursement period?
Brandon Folkes: It does. Then just to confirm, so there's been no actions taken on the DefenCath sales and marketing infrastructure ahead of the lower reimbursement period?
Speaker #3: No. There have been no actions taken in the company. No.
Susan Blum: No.
Joseph Todisco: No.
Susan Blum: No.
Joe Todisco: No.
Susan Blum: There's been no actions taken in the company. No, we're-
Susan Blum: There's been no actions taken in the company. No, we're-
Joseph Todisco: No.
Joe Todisco: No.
Speaker #1: No.
Speaker #5: Perfect. Thank you very much, and congrats on the progress.
Brandon Folkes: Perfect. Thank you very much, and congrats on the progress.
Brandon Folkes: Perfect. Thank you very much, and congrats on the progress.
Speaker #1: Oh, thank you.
Joseph Todisco: Oh, thank you.
Joe Todisco: Oh, thank you.
Operator: This concludes our question and answer session. Thank you for attending today's presentation. You may now disconnect.
Operator: This concludes our question and answer session. Thank you for attending today's presentation. You may now disconnect.
