KORU Medical Systems, Inc.

Greetings. Welcome to the KORU Medical Systems third quarter 2026 earnings 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, Investor Relations. Thank you, Louisa. You may begin.

Thank you, operator, and good afternoon, everyone. Joining me on the call today are Adam Kalbermatten, President and Chief Executive Officer of KORU Medical Systems, and Tom Adams, Chief Financial Officer. Earlier today, KORU released financial results for the third quarter ended September 30th, 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 Tuesday, November 10, 2026, 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 Adam Kalbermatten, CEO. Adam, please go ahead.

Thank you, Louisa, and good afternoon, everyone. I'll first begin with commentary on this quarter's business highlights before handing the call over to Tom to discuss financial results and our updated guidance. Before diving into the results, I want to make several points. KORU has an incredible opportunity ahead of it, and we are working hard to capture it. I don't want to get ahead of ourselves, but I'd like to note the following. First, we are executing on the core business. As we guided in our Q2 call, are top line growth slowed in Q3 and we are on track to deliver high teens growth in Q4. We continue to grow our recurrent patient base ahead of the market and have made business profitability improvements and are pleased with the results. New initiatives take time and we are working on some big things that could significantly expand our patient base. We are progressing the business along multiple strategic dimensions opening new geographies, getting new drugs on label, addressing new indications, and adding new technologies. If we execute on these strategic priorities, the business will inflect. I won't put a precise date on that today, but in the meantime, you should expect us to run a healthy, profitable, growing business. Now I will dive into Q3. Revenue was $11.6 million. up 11% year over year, with margins expanding to 65.2%. Our top line this quarter reflects the timing we discussed last call. Our domestic core continued to perform well, while timing in international markets moderated our growth. What I want you to take away from this quarter is not the top line alone, but the quality of the underlying results and the direction we are heading. We achieved our second consecutive quarter of positive net income, and adjusted EBITDA made tangible progress on every strategic pillar we previously outlined that will drive our next phase of growth. With our current recurring revenue scale, profitability profile, and cash balance, we will fund the business while continuing to invest in growth. This quarter, we delivered proof points that will continue to fuel our growth. We signed new distribution partnerships in both Europe and Africa. Three U.S. specialty pharmacies are now dispensing KORU products to support the home administration of Restivio. And our new drug pipeline advanced across SEIG and oncology. KORU continues to be the global leader in large volume subcutaneous drug delivery. supporting the ongoing shift toward patient-administered therapies and home-based care in healthcare systems around the world. The IG market continues to grow in the high single digits annually, and our strategic priorities remain focused on bringing more drugs onto our label and capturing even larger markets, including patients with secondary immunodeficiencies, oncology, and rare disease indications. Let me discuss each in turn. We consistently deliver above-market growth domestically, and this quarter was no exception, with $8.1 million in domestic core revenues. KORU remains the market-leading solution in the United States, and we continue to see new patient starts in existing accounts while also onboarding new accounts. a strong underlying recurrent patient profile, and our ability to win new patient starts in an expanding IG market all contribute to our consistently strong top-line results. Specialty pharmacy sales of Restigio contributed to the increase in domestic core revenues. In the quarter, three US specialty pharmacies started dispensing KORU products for the home care of the drug, two of which use the complete KORU system and one using just our needle set. We expect Restigio to drive growth within the specialty pharmacy channel as new patient starts increase. We see the total Restigio market potential growing to around 100,000 infusions over the next three to five years. Internationally, our geographic expansion strategy continues to gain traction. and I am very excited about what we are accomplished this quarter. We signed a new sales and distribution agreement with a partner in one of Europe's largest markets to further support new patient starts across multiple countries with large patient populations. We received our first order under that newly signed sales and distribution agreement and expect to start seeing the benefits in the fourth quarter. This partnership is especially beneficial because of their position as a wholesaler, home care provider, and pharmacy within the healthcare system. All these components together create an integrated service network that will now use the KORU Freedom Infusion System. This positions us for continued scalable growth, focusing on new patient starts. In another exciting international milestone, We signed a sales and distribution agreement with a new partner in Africa and shipped our initial order this quarter. This is a meaningful step in broadening our global footprint and bringing subcutaneous infusion therapy to an entirely new patient population. Each new market we enter strengthens our foundation for long-term international growth. And the momentum we are building is exactly what we hope to see. As a reminder, international markets differ in how the device supplier is chosen for the health system. In tender-based markets, pharmaceutical companies bid to supply their pharmaceutical asset, and as part of that tender, they select which device will be used to deliver it. Winning the pharma relationship effectively wins the device volumes as well. This differs from distributor-based markets where there is no central tender Home care companies and hospitals drive the device decision independently, which means growth comes account by account rather than through a single tender win. KORU is active in both models. As anticipated, while our international sales slowed slightly as we navigated our launch into a competitive distributor-based market, the opportunity for growth in under-penetrated international markets remain intense. with the help of our new relationships, we will continue to build our revenues in OUS markets. We expect fourth quarter international performance to be strong. Partnerships like the additions in Europe and Africa are laying the foundations to strategically unlock these markets abroad and efficiently. We will continue with that same disciplined approach to the international markets and we'll keep looking for additional partnership opportunities that will drive enhanced market access internationally. Turning to our pipeline. You can think of our strategy here as focused on three elements. First, bringing additional drugs onto our label. Second, enhancing our existing technology. And three, building the foundation for connected health. I'll walk through where each of these stands today, starting with new drugs and novel therapies. As it relates to new drugs on label, as mentioned before, I want to make sure we manage expectations as these are closely tied to our pharmaceutical partnerships. We continue to make progress with existing commercial and additional pharma development partners, and the opportunities that we're working on are highly sensitive and other partners. Many involve multi-billion dollar drug assets and these opportunities are highly competitive. As a result, I will only share further detail when our pharma partners are prepared to disclose more information publicly or when we have launched a commercial partnership. We do have specific updates to share on one partnership across facilitated subcutaneous therapies. As many of you might have seen, detailed results from a pivotal 2-3 trial of an investigational facilitated subcutaneous immunoglobulin 20% therapy were presented by Takeda at ECID last month. The trial met its primary endpoint, and the data showed that compared with Hycuvia, the therapy delivered the same IgG dose in half the volume with infusion times shortened by more than 40% for a single infusion site while maintaining up to once monthly dosing. This is a compelling profile for patients and it reinforces the broader industry shift towards subcutaneous administration in the home setting. exactly the trend KORU is positioned to support. On the enzyme replacement therapy program in our pipeline, another promising milestone was reached. Patients are being dosed with the KORU Freedom Infusion System in our pharmaceutical partner's phase three clinical trial for this investigational drug. It has an estimated patient population of approximately 5,000 patients. Stead consistent progress like this is exactly what we want to see as these programs advance. Another pharmaceutical partner is approaching a phase three trial of their nephrology asset with the execution of a follow-on statement of work to support international clinical trials this quarter. The drug has an estimated patient population of approximately 10,000 patients and is a great signal of the growing scope in ambition of these collaborations. As a reminder, these collaborations are designed to navigate the multi-year pharmaceutical development pathway. While they often start with KORU providing clinical trial devices, we look at them as opportunities to serve as the engine fueling our long-term growth pipeline. We have also initiated discussions and provided samples with several new pharmaceutical companies. The pipeline is building just as we envisioned. Our 510K application for deferoxamine is still under review with the FDA. As you may recall, this drug is an iron chelating treatment, and the current infusion of this drug is with the CoRoot pump, which has been used off-label in the past. We are pursuing this label independent of a pharmaceutical partnership. We anticipate it will be a contributor in 2027 and beyond. We believe clearance could come in the near term, though timing rests with the agency, and we remain fully committed to getting deferoxamine on label. We are optimistic about where we stand and are excited about the next steps. Our conviction in oncology continues to be strong, and we believe this market represents a long-term growth inflection opportunity for KORU. We are mindful that these drugs represent high-value strategic assets to our pharma partners. And while we're making progress, we cannot provide explicit commentary on the details. We plan to share further details in the first half of 2027. On secondary immunodeficiency, we continue to expect pivotal trial endpoints toward the end of 2027. Many of those trials use SCIG drugs already on our CORU label. We are tracking them closely and speaking with pharma partners so that we are ready with the right channel and approach as US indications come online. Our focus is on disciplined execution against each of these pharmaceutical programs, and we plan to update you as we reach each milestone. As you can see, has a robust pipeline backing an already strong and continuously growing recurring core business. On the internal product development front, there is a great deal to be excited about. We continue to make excellent progress on our Freedom360 Next Generation pump, and we are finishing the final touches on our regulatory submission, which remains firmly on track for the end of the year. This is a significant milestone for the company, and the team has done an outstanding job getting us to where we are today. We believe Freedom360 will be a great addition to the portfolio, especially for the patients who have doses requiring multiple pre-filled syringes. Last quarter, we highlighted the acquisition of a connected monitoring technology asset. While it is still early, we now have functional prototypes that enable productive discussions with the pharmaceutical and specialty pharma companies. We are encouraged by these discussions and believe the technology will enhance the patient experience, deepen our value proposition, and provide meaningful real-time data insights to our pharmaceutical and specialty pharmacy partners. initial feedback from these partners is enthusiastic and very positive. They are helping us shape our connected vision for the future. Stepping back, the story of this quarter is simple. A growing business that is above market growth with the second consecutive quarter of positive net income and EBITDA. A live specialty pharmacy channel for Restigio a new distribution partnership unlocking Europe and another unlocking Africa, and a pipeline spanning facilitated SCIG, oncology, and connected health that widens our competitive moat every quarter. The foundation is built, the momentum is real, and we are executing with discipline. I am proud of this team and more confident than ever in the path we are on. With that, I'll turn the call over to Tom to discuss financial results. Tom? Thanks, Adam.