KORU Medical Systems, Inc.

Greetings and welcome to CORU Medical Systems' second quarter 2026 earnings conference call. At this time, all participants are on 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. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Louisa Smith. Thank you. You may begin.

Thank you, operator, and good afternoon, everyone. Joining me on the call today are Adam Kalbermatten, President and CEO, and Tom Adams, CFO. Earlier today, KORU released financial results for the second quarter ended June 30, 2026. 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, August 5, 2026. at approximately 4.30 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 Adam. Please go ahead.

Thank you, Louisa, and good afternoon, everyone. I'll begin with commentary on this quarter's highlights and strategic progress. Tom will then speak to our financial performance and the current assumptions around guidance before we open the line for questions. This is my first quarter reporting as CEO. and I want to start by saying how excited I am about the company's position and the opportunities that lie ahead for KORU. Today, we are the global leader in large volume subcutaneous infusion devices for drug delivery, serving the at-home infusion needs of roughly 60,000 chronic and recurring IG patients through our Freedom Infusion System. The broad market opportunity for subcutaneous IG administration continues to shift from hospitals to infusion centers and increasingly into the home. Coru continues to be positioned as a direct beneficiary of that shift by providing an easy to use and differentiated way for patients to deliver their therapies outside the clinical setting. My focus as CEO is on extending our leadership position as the broader drug landscape follows this shift towards alternate sites of care focused on subcutaneous infusion versions versus IV. We are constantly assessing opportunities to bring more drugs onto our label and improve our technology. To achieve this, our fundamental strategy remains focused on scaling our industry-leading mechanical platforms while selectively integrating smart capabilities that complement our core devices. By adding data-driven smart connectivity into our existing infusion systems, as is our intention with this quarter's technology asset acquisition, we aim to provide an enhanced level of support for the patients who want it while offering valuable data-driven insights to our pharmaceutical and specialty pharmacy partners. This approach allows us to preserve the simple, trusted, mechanical experience that patients rely on while building the foundational capabilities to lead the drug delivery market as it gradually adopts connected health solutions. I'm pleased with our performance in Q2, delivering $12 million in revenue, representing growth of 18% for the quarter and 20% for the first half of the year. This momentum is built on the strong, predictable foundation of our recurring IG patient base coupled with our proven ability to capture new patient starts and actively expand our market share both in the U.S. and internationally across both home and alternate site clinical environments. Financially, we executed well. We improved gross margin by nearly 200 basis points above our 2026 range, and notably, we delivered positive net income for the first time since 2019, a major milestone in KORU's strategic evolution and further evidence of our ability to drive profitable growth. As I step into the CEO role, we are actively building upon this momentum. Our foundational three pillar strategy remains our central focus and we are executing against it with a heightened sense of urgency, scale, and vision. Looking at our growth pillars on the domestic side, we grew our core business more than 12% year over year, which is heavily supported by patient retention and continued market share gains with new patient starts in a growing population. Our domestic business continues to remain strong and has been growing at or above expectations in the market quarter after quarter. On Restego, we continue to see adoption with new patient starts and are receiving strong feedback from both clinicians and patients. We view Restego as a contributor to our domestic business, but more importantly, as a strategic validation of our platform's capability to deliver innovative non-IG chronic therapies. We are highly encouraged by this ongoing expansion which further reinforces our ability to successfully diversify our clinical indications and expand our addressable patient footprint. Internationally, we grew the business by 59% year over year. This strong performance was driven by high volumes of both pumps and consumables, which was fueled by sales to distributors who are supporting the conversion of patients into pre-filled syringe formats. Along with strong momentum from new patients starts within our established international market. Looking ahead to the back half of this year, we remain highly focused on executing our international expansion, though we expect our near-term international core growth to moderate as we navigate some specific regional launch dynamics. As we continue to build out our presence in newer pre-filled syringe markets, some markets may take longer to ramp than we initially anticipated. In tender markets, we win the pharma practically overnight. In other markets like the U.S., where we win every new patient start as our distributors methodically convert from vial to PFS one by one, it may take a little bit more time. In our Q1 call, we noted that our growth rates in these newer regions can be variable as we deepen our local market knowledge and expand our capabilities. It is crucial for the long-term health of the business that we establish the right distribution and reimbursement pathways. Unlocking this opportunity is simply taking us a little longer than forecasted in our assumptions. While this pacing may impact the international core growth rate in the short term, we remain encouraged by the progress in these markets as the foundational pieces fall into place. We also remain confident in the size of the overall international pre-filled syringe market opportunity and are bullish in our long-term ability to capture significant market share internationally. Building the right commercial and regulatory foundation in these new conversion markets takes time. but we are highly disciplined and diligent at the outset so that we are positioned to maintain permanent market leadership in the future. In our PST business, we continue to systematically advance our established programs while initiating early-stage discussions with new potential pharmaceutical partners. Because many of these collaborations are designed to navigate the multi-year pharmaceutical development pathway, they serve as the engine for fueling our long-term growth pipeline. Biogen's recent acquisition of Apellis is an example of this. There may be some challenges to the timing and magnitude of near-term clinical trial activity as they work through standard post-acquisition integration activities, but remain focused on a long-term partnership and supporting their clinical development pipeline as their subcutaneous infusion programs advance. Turning to some strategic updates, we are pleased to announce our acquisition of a connected monitoring technology asset, which we believe will enhance the patient experience, deepen our value proposition, give us a meaningful new capability in generating real-time data insights and assist us in entering new clinical trials with pharmaceutical partners. Ultimately, the technology will support a better day-to-day experience for patients in addition to providing specialty pharmacies and pharmaceutical companies real-world evidence across the patient base. Additionally, we believe this will be a key differentiator of the best-in-class KORU mechanical platform in our PST business for partners will have real-time insights into dosing data during clinical trials. This capability will be valuable because precise adherence tracking and real-world data capture are vital for ensuring trial integrity, accelerating regulatory approval timelines, and ultimately generating the robust evidence required to secure favorable payer reimbursement upon commercialization. This is a multi-year build for us, but we are very excited to have the technology and see it as an important building block for how we position our platform going forward. It reflects the broader approach we intend to take as we keep expanding the KORU platform and remain thoughtful about the right opportunities that have potential to strengthen our market positions. Turning to an important emerging catalyst for our core SCIG business, I want to highlight the continued industry advancements we are seeing within secondary immunodeficiency, or SID, Today, SID market growth is expanding beyond the broader SIG market, largely driven by patients who develop immunodeficiencies following treatments with immunosuppressive drugs such as chemotherapy or cell therapies for various cancers and autoimmune conditions. To address this growing unmet need, major pharmaceutical players have made SID a clinical priority, with several ongoing pivotal clinical trials expected to reach their endpoints over the next 12 to 18 months. As these trials conclude, and Skig Manufacturers expand their active marketing efforts to hematologists and oncologists, we anticipate a significant expansion in reimbursement coverage domestically for secondary immunodeficiencies. For CORU, this represents a new incremental high-growth patient population. Because our platform is already a trusted standard of care for subcutaneous IgE delivery, we are perfectly positioned to capture this volume and meaningfully broaden our total addressable market with these new indications as they come online. Turning to our regulatory pipeline, I would like to provide an update on our two recent 510 submissions, Fezgo and Defiroxime. First, regarding our broader oncology strategy and our submission for use of the Freedom System with Fezgo, we've made a strategic decision to pivot our focus towards alternative molecules for our initial entry into the US and withdraw our application from the FDA for Fezgo in the US. Following productive conversations with the agency, there are specific considerations with the Fezgo label that are making pursuing other high volume oncology biologics more favorable to our oncology strategy in the U.S. Our conviction in the oncology market remains unchanged. It's a core strategic priority where we see a large opportunity for COVID. Simultaneously, we continue to advance our international oncology initiatives, including with Fezgo, which we view as a highly compelling long-term growth driver bolstered by the strong insights and positive nursing studies we've already generated in Europe, such as our work in Denmark last year. While we refine our U.S. oncology pathway, our regulatory momentum in other non-IG therapies remains strong. As a reminder, KORU officially submitted a 510K application for the clearance of the Freedom Infusion System with deferoxamine at the end of the first quarter. That application remains active, and our team is engaged in productive, collaborative discussions with the FDA as we navigate the standard review process. We're committed to getting deferoxamine on label and believe it will unlock an estimated 200,000 annual U.S. infusions and further solidify our platform's expansion into non-IG therapies. Regarding our new product pipeline, we remain on track with our target for a 510K submission by the end of next year for our next generation pump, which we're calling Freedom 360. In the second quarter, we completed the final stages of the development process for Freedom360, which were steps that had represented the greatest area of risk in the development timeline. With that critical milestone now behind us, we are confident in our U.S. submission timing. I am proud of the team's execution and the robust growth we demonstrated across the business this quarter. Stepping back, our fundamental strategy remains rooted in our three growth pillars, but as CEO, my mandate is to actively accelerate our execution against them. I am more energized by the magnitude of the opportunities ahead of us today than I was on day one. We are successfully transforming KORU from a highly reliable mechanical device manufacturer into a dominant digitally enabled drug delivery platform. Whether it is preparing for our upcoming Freedom360 launch, advancing our international and oncology roadmaps, or integrating digital connected health capabilities, we are deliberately widening our competitive moat. We have a clear, disciplined strategy to drive sustainable, profitable growth and deliver significant long-term value to our shareholders and the patients we serve. With that, I'll turn it over to Tom to walk through financials.