CorMedix Inc.

Good day and welcome to the Core Medics Inc. Second Quarter 2025 Financial Results Conference Call. All participants will be in listen-only mode. Should you need assistance, please email conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To draw your question, please press star then two. Please note this event is being recorded. Now I'll turn the conference over to Daniel Ferry, Managing Director of Lifestyle Advisors. Please go ahead.

Good morning and welcome to the Core Medics Second Quarter 2025 Earnings and Corporate Update Conference Call. Leading the call today is Joe Sidisco, Chief Executive Officer of Core Medics. And he is joined by Dr. Matt Damon, Executive Vice President of CFO. In addition, Beth Zelnick-Kaufman, EVP and Chief Legal and Compliance Officer. Liz Hurlburt, EVP and Chief Clinical Strategy and Operations Officer. And Erin Mystery, EVP and Chief Commercial 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 meeting set forth in the Private Securities and Litigation Reform Act of 1995. These statements are statements other than statements of historical facts 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 Core Medics filings at the SEC, which are available free of charge at the SEC's website or upon request from Core Medics. Core Medics may not actually achieve the goals or plans described in these forward-looking statements. Investors should not place undue reliance on these statements. Core Medics 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. Gap to non-GAAP financial reconciliations and supplemental financial information are provided in Core Medics earnings release and the current report on Form 8K filed with the SEC. This information is available on the Investor Relations section of Core Medics website. At this time, it's now my pleasure to turn the call over to Joe Tadisco, Chief Executive Officer of Core Medics. Joe, please go ahead. Joe, please go ahead.

Thank you, Dan. Good morning, everyone, and thank you for joining us on this call. Today, concurrent with our second quarter earnings announcement, Core Medics announced the acquisition of Malinta Therapeutics in a combination cash and stock transaction. This deal is transformational for Core Medics, creating a fully diversified specialty pharmaceutical company with a broad portfolio of commercial and pipeline products concentrated in the acute care and anti-infectives areas. The Malinta product portfolio and existing operational infrastructure are highly synergistic with Core Medics current commercial portfolio and sales deployment and also provides an exceptional complement to future potential expanded indications for our lead product, DefendCas. I would like to congratulate Christine Miller, Malinta Therapeutics President and CEO and her team on building such a high performing organization with deep expertise in the hospital acute care and infectious disease arena. From a financial standpoint, Malinta adds to Core Medics a stable base of revenue for which we are currently guiding full year 2025 Malinta revenue between $125 and $135 million dollars spread across multiple assets, including six commercial stage products in the acute care and infectious disease space. We see opportunities for growth from both the existing commercial assets as well as their lead pipeline drug opportunity, a potential expanded indication for Rezio for the prophylaxis of invasive fungal diseases in adult patients undergoing allogeneic blood and marrow transplantation. In terms of key highlights of the transaction, the acquisition is expected to be near-term accretive with double digit EPS accretion in 2026 and we are forecasting that will drive mid to long-term revenue and cash flow growth. The addition of the pipeline opportunity of Rezio's expanded indication for prophylaxis provides a valuable growth driver of future revenue and we estimate that if approved peak annual sales potential in this indication could exceed $200 million. In the combined company, we also expect to capture significant near-term operating expense synergies estimated in the range of $35 to $45 million, which will foster near-term EBITDA growth and EPS accretion. We have already submitted the necessary filings to the Federal Trade Commission in order to comply with the Hartscout-Rodino Act, otherwise known as HSR, and we expect to close this transaction as early as September 1st, pending regulatory approval and other customary conditions of closing. The deal was structured as a combination of cash and stock with Deerfield Management Company to receive $40 million of the upfront purchase price in the form of CorMedx equity. Deerfield has also subscribed to $35 million of the $150 million debt offering executed concurrently with the transaction, which was used to fund the cash portion of the purchase price. We are excited to have Deerfield as a long-term investor in the new combined company, given their long history as an investor in Malinta and in the healthcare space. On a pro forma basis, we are guiding to full year combined 2025 revenue of $305 to $335 million, with $180 to $200 million of contribution from DefendCathNet sales. In addition, we are guiding to pro forma, fully synergized adjusted EBITDA for 2025 in the range of $150 to $170 million. Turning now to the CorMedx business and our second quarter updates, we were excited to announce a few weeks ago that our LDO customer initiated purchases of DefendCath, and we can now confirm that they have initiated utilization in patients beginning in early July. Based upon feedback from the LDO, their rollout plan involved a limited clinic rollout for the month of July to establish workflow practices and a system-wide rollout that is taking place this week across all of their more than 2,000 clinics. We expect a system-wide rollout to initially target approximately 6,000 patients. However, we do not yet have visibility from the LDO into the pace for that rollout. As we get more information and better visibility from our LDO partner, we will update investors accordingly. On the clinical front, we have made great progress on our phase three study for DefendCath in the reduction of CLABSI in adult patients receiving parental nutrition through a CVC. We now have multiple sites up and running and patients enrolled, and we are on track to complete the study and submit the NDA in the late 2026 to early 2027 timeframe. We have also begun enrollment in our pediatric study for the reduction in CRBSI in pediatric patients undergoing hemodialysis through a CVC, with the first patient expected to begin dosing in August. Lastly, we have made the decision to perform an interim analysis of our real-world evidence study with U.S. Renal Care and hope to be in a position to provide interim data by the end of 2025. This is significant as we aim to evaluate patient outcomes and the impact of DefendCath utilization on the cost of patient care, infection rates, hospitalizations, and mortality. All metrics that are critical to our goal of making DefendCath the standard of care for the reduction of bloodstream infections in patients getting hemodialysis through a CVC. I'd now like to turn the call over to Matt to discuss the company's second quarter financial results and financial position. Matt?