KORU Medical Systems, Inc.

Greetings, and welcome to Colroom Medical Systems' third quarter 2025 earnings conference call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note, this conference is being recorded. I will now turn the conference over to Louisa Smith, Head of Investor Relations. Thank you. You may begin.

Thank you, Operator, and good afternoon, everyone. Joining me on the call today are Linda Tharby, President and CEO of KORU Medical Systems, and Tom Adams, Chief Financial Officer. Earlier today, KORU released financial results for the third quarter ended September 30, 2025. A copy of the press release is available on the company's website. I encourage listeners to have our press release in front of them, which includes our financial results and commentary on the quarter. Additionally, we will use slides to support further commentary in today's call, which are also available on the investor relations section of our website. During this call, we will make certain forward-looking statements regarding our business plans and other matters. These comments are based on our predictions and expectations as of today. Actual events or results could differ materially due to risks and uncertainties, including those mentioned in the associated press release and our most recent filings with the SEC. We assume no obligation to update any forward-looking statements. During the call, management will also discuss certain non-GAAP financial measures. You will find additional disclosures, including reconciliations of these non-GAAP measures with comparable GAAP measures in our press release the accompanying investor presentation, and SEC filings. For the benefit of those listening to the replay, this call was held and recorded on Wednesday, November 12, 2025, at approximately 4.30 p.m. Eastern Time. Since then, the company may have made additional comments related to the topics discussed. I'd now like to turn the call over to Linda Tharby, President and CEO. Linda, please go ahead.

Thank you, Louisa. Good afternoon, everyone, and thank you for joining today's earnings call. I'll begin with some commentary on our third quarter highlights and strategic progress, and then Tom will review our financial results before we open the call for questions. During the third quarter, we delivered strong results, accelerating revenue growth, outstanding performance in our core immunoglobulin business, new additions to our PST pipeline, and continued progress towards sustained profitability. We achieved our second consecutive quarter with more than $10 million in revenue, representing 27% year-over-year growth. The key growth driver was our core subcutaneous immunoglobulin, or SCIG, business, which grew 30%, driven by international expansion, continued global share gains, and strong underlying patient growth. While we saw some quarterly shifts in purchasing patterns between domestic and international markets, both underlying businesses remain robust. Tom will provide additional details on the shift in geographic mix. From a strategic standpoint, we advanced several important initiatives this quarter. We recently announced two new PST collaborations, underscoring our commitment to expanding our pipeline, broadening our label, and reaching additional patient populations. I'll share more detail on those collaborations during our pipeline discussion. We also made meaningful progress toward our goal of expanding into oncology infusion centers, successfully completing a US-based oncology study that validated CORA's value proposition in this market. We remain on track for a 510 filing by the end of 2025. On the financial front, we delivered gross profit growth of 21% year over year, achieved positive adjusted EBITDA, and generated positive cash flow. To reflect our confidence in the business and continued execution, we are raising our full year revenue guidance to $40.5 to $41 million, representing growth of approximately 20% to 22%. and we are reaffirming our guidance for gross margins and cash flow from operations. Now turning to our U.S. SCIG business, which represents our largest recurring revenue base. As shown on slide four, external forecasts project SCIG market growth of approximately 9% annually over the next five years, outpacing the IVIG segment. This growth outlook is supported by several key factors. First, an increasing number of new patients are being diagnosed and treated with SCIG as their first line therapy. With approximately 20% market penetration today, SCIG still has significant headroom for expansion in the broader immunoglobulin therapy market. Second, we're seeing broader diagnosis of secondary immunodeficiency, or SID, driven by an aging population, higher prevalence of chronic illnesses, and increased use of immunosuppressive treatments, such as chemotherapy and CAR-T cell therapy. Importantly, we're also seeing growing clinical activity in the SID area, which could ultimately support new reimbursement coverage and add further momentum to SCIG adoption. Finally, pharma partners continue to invest heavily in the SCIG space. through device innovation such as pre-filled syringes and a strong pipeline of clinical trials and label expansions. Our leadership position in this category remains very strong. U.S. end-user demand and sales to specialty pharmacies are at or above market growth rates, reflecting solid execution and the continued health and momentum of our U.S. SCIG business. Now turning to international, which continues to be one of the most exciting areas for our accelerated growth potential. Over the past year, we've grown our international market share from roughly 10% to 15 to 20% of the underlying $60 million OUS SCIG market. We see further growth potential in several key areas. First, the shift to pre-filled syringes in Europe. This represented the majority of our growth this quarter, The efforts to convert a market from vials to pre-filled syringes using our freedom infusion system, including both the pump and consumables, have been very successful. By simplifying administration steps, our system makes it easier for patients to use and for healthcare professionals to train them. Several additional EU countries are planning similar conversions, and our innovation pipeline, combined with strong alignment with pharma partners, positions us well to further penetrate the top European markets. At the same time, we continue to grow infusion set sales in markets that still primarily use vials. Overall, we feel very confident about our international momentum. We are targeting to accelerate our overall market share from the mid-teens into the 40% range, representing a $10 to $20 million opportunity over the next several years. This next slide highlights our progress with IG pharma partners. Today, we have seven active collaborations across all four major IG manufacturers, which continue to drive core growth alongside their new drug, device, and indication expansion. Commenting on changes from last quarter, we saw two previously announced collaborations push their launch dates into 2027. We have updated our pipeline accordingly. Importantly, we don't see this as having any material impact on current projected revenue. Highlighted in green on the bottom row is our most recent collaboration, which we announced last week. This is particularly exciting because the relationship with this drug manufacturer expands our potential into the broader patient populations for an IG drug where we currently hold a lower global share position. Overall, these IG collaborations are a key driver of both share gains and geographic expansion in the subcutaneous market, reinforcing our strategy of partnering with pharma companies to accelerate adoption and growth. Turning now to new drugs outside of IG, we currently have nine active collaborations with four potential new drugs expected to be added to our system by the end of 2026. Recent updates to this pipeline are highlighted in green on the slide. First, a rare disease candidate has been pushed by one quarter to Q1 2026, following FDA requests for additional testing data. We do not expect this to materially impact our timeline or 2026 revenue opportunity. Second, we are seeing expanded commercial potential for an additional Ampavelli indication, a prior clear drug. which we are currently supporting in phase three trials. Finally, we recently announced our collaboration with Forecast Ortho, supporting their clinical trials for treatments that address complications from joint replacement surgeries. This marks our first opportunity in the orthopedic space and adds approximately 140,000 potential infusions. We estimate that the non-IG drugs in our pipeline with an anticipated launch date between now and 2027 have a commercial potential for CORU of up to $10 million by the end of 2028. With a clinical pipeline of more than 95 drugs exceeding 10 mLs across the pharma landscape, we continue to actively pursue additional assets to expand and strengthen our pipeline. This quarter, we also continue to advance our entry into the oncology infusion space. Currently, there are seven subcutaneous oncology drugs administered in infusion clinics using manual syringe push, which requires nurses to stand over patients and inject highly viscous drugs over a period of five to 10 minutes. Following our successful EU study where 97% of nurses preferred the Freedom Edge infusion system over manual syringe administration, we launched a US pilot study in Q2 which concluded in Q3. In total, five oncology infusion clinics participated, administering two leading oncology drugs. The results were very encouraging. We achieved a 100% success rate in administration and met all safety requirements. We also observed high satisfaction among nurses and patients with improvements in physical strain and patient comfort using the freedom system compared to manual syringe push. Importantly, 70% of nurses reported the ability to multitask, including treating other patients, adding the potential for improved clinic workflow efficiency. Our value proposition continues to resonate across all sites studied. We are progressing in collaboration with one of the seven oncology drugs and remain on track for a 510 case submission to the FDA, either in Q4 of this year, subject federal timing, or in Q1 2026, with anticipated commercial market entry in the second half of 2026. The total addressable market for oncology infusion consumables is significant, projected to grow from approximately 60 million in 2025 to 138 million by 2030. We are being very diligent about our market entry and regulatory strategy, ensuring that when we enter oncology, we do so in a way that supports patients, providers, and long-term growth. Overall, I'm extremely proud of the team's execution and the strong momentum we built across our business during the first three quarters. With robust growth in our U.S. and international markets, meaningful pipeline progress, and strategic advances across both IG and non-IG opportunities were well positioned. With that, I'll turn the call over to Tom to review our financial results and share our updated guidance for 2025.