KORU Medical Systems, Inc.

Hello and welcome to the Kourou Medical System's second quarter 2025 financial results conference call and webcast. At this time, all participants are in listen-only mode. The question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would now like to turn the conference over to Louisa Smith of the Gilmartin Group. Please go ahead.

Thank you, Judith, and good afternoon, everyone. Joining me on the call today are Linda Tharby, President and CEO of Coru Medical Systems, and Tom Adams, Chief Financial Officer. Earlier today, Coru released financial results for the second quarter and did June 30th, 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 you, which includes our financial results as well as 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 included in 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 6, 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 strategic vision and the opportunity ahead in the large volume subcutaneous drug delivery market, followed by highlights from the second quarter. Tom will then review our financial results before we open the call for your questions. Let me start with the big picture. CORU is a leader in the large volume subcutaneous drug delivery market, with the freedom system being cleared for use with the first drug in 2017. We are well-positioned to capitalize on the accelerating shift from hospital IV-based treatments to more convenient subcutaneous therapies delivered at home and in infusion clinics. Today, our freedom system serves approximately 45,000 patients, primarily on IG therapy for chronic conditions, providing a strong, stable base of recurring revenue. We are also focused on expanding beyond SEIG where we currently have 10 active opportunities and many more we are pursuing to bring new drugs onto our Freedom Infusion platform. Over the past decade, healthcare has begun to shift from the hospital to infusion clinics to the home, and Quoro is uniquely positioned to capitalize. We are cleared for use with all SCIG drugs on the market, Between subcutaneous and IV formulations, we estimate that the opportunity for drug delivery devices for IG therapy is approximately $450 million, with only 20% penetrated by subcutaneous formulations. Beyond IG, there are currently more than 50 drugs in development that are formulated at volumes of greater than 10 ml. Requiring a specialized drug delivery solution, a significant opportunity that aligns with CORU's core competencies in large volume drug delivery. Our strategy is based on three growth pillars, depending on growing our core domestic business where we are the market leader and have the opportunity to increase penetration, expanding internationally where sub-Q penetration is higher and we have share growth opportunity, and enabling the delivery of additional drug therapies to reach more patients. Now turning to our results for the second quarter, We reached a historic milestone in Q2 with over $10 million in revenue. Revenue grew over 20% with continued momentum across all three strategic growth pillars. Our domestic core business continues to outperform a growing SEIG market, and we are seeing significant acceleration and international expansion with over 30% growth. Our pharma services and clinical trial segment also saw strong growth driven by clinical supply agreements. We continue to expand our patient base through market share gains with recurring revenues from chronic SCIG patients. Further, the FDA recently approved an expanded indication for Mpivelli, a non-SCIG drug already on our label for C3G and primary IC MPGN, creating further opportunities. We also submitted a 510K ahead of schedule for a rare disease biologic. another milestone in our strategy to bring more non-IG drugs onto the Freedom platform. Following our success in the EU, we have also initiated a US-based oncology pilot program with over 50 patients enrolled at six infusion centers across four different subcutaneous oncology drugs. Insights from this pilot will help with data generation to inform our strategic decisions around pursuit of the oncology opportunity. which we look forward to updating you on in the coming quarters. We also advanced our goals towards profitability this quarter with Q2 cash usage of $600,000. This was driven by the trifecta of strong revenue growth, sustained gross margin performance, and disciplined capital allocation that is delivering meaningful operating leverage. And finally, I'm excited to announce that Adam Calbermatten has joined CORU as Chief Commercial Officer. bringing 20 years of success in leading drug delivery partnerships across pharma and biotech in both large and small cap companies. Adam will be instrumental in further acceleration of our global commercial and PSD strategies. Two weeks in, he has hit the ground running. Let's take a closer look at performance across our three strategic pillars, starting with our core business results. Our domestic core business continue to outperform strong SCIG market growth fueled by market share gains and key accounts. The addition of the new label expansion for Mpavelli will provide an opportunity to further grow our patient base. Internationally, we continue to deliver significant growth fueled by expansion into new geographies and our first prefilled syringe market conversion in Europe, an early step in what we believe is a much larger long-term strategy. We expect even further contribution from our pre-fill efforts in the back half. You'll notice we've updated our pipeline slide distinguishing between core IG opportunities and new drugs added to our label. I'll cover the latter on the next slide. We believe this view more clearly illustrates how device innovation, label expansion, and strategic collaborations are driving share gains and targeted geographic expansion for our core IG business. Within our IG partnerships, we made two key advances this quarter. First, we completed all pump and consumable registrations in Japan, paving the way for sales alongside two leading IG therapies. We expect to realize sales in the back half of this year. The final step, clearance of our flow controller with the third IG drug, is expected in 2026. In addition, one of our IG drug collaborations progressed to a combined phase two, three trial. More broadly, we continue to make strong progress across our IG device and drug partnerships with a major milestone on the horizon, multiple anticipated clearance for our next generation pump in 2026, which will unlock new market share and geographic expansion opportunities. Moving to our third growth pillar, we continue to see good progress in our opportunity to enable the delivery of more drugs and ultimately bring more patients to our platform. Our pipeline includes five new drugs that we expect to be commercialized on our Freedom Infusion platform by the end of 2026, and 10 total pipeline drugs. A mix of independent 510 submissions and formal pharmaceutical collaborations. Notably, we named two drugs we are pursuing independently. Defroxamine for ion chelation and vancomycin, an antibiotic, with both now expected to receive clearance by 2026. In total, these two drugs represent approximately 1 million total infusions, of which we expect to realize about 500,000 in incremental revenue next year. Through our relationships with specialty pharmacies, we're in the process of identifying and potentially pursuing additional drugs that fit into this category to drive additional annual infusions into our core business. As noted in my opening remarks, the FDA recently approved an expanded indication for Amphibeli. representing approximately 100,000 annual infusions. We estimate Coro's opportunity to be around 20,000 of those infusions. We've also submitted ahead of schedule a 510K per rare disease biologic representing 40,000 annual infusions. We hope to receive clearance on this by the end of this year. A revised total addressable market for new drugs now stands at approximately 1.8 billion. based on estimated patient populations and dosing schedules and ASPs from our prior 2.2 billion. As our new drug pipeline continues to evolve, we will assess each therapy's infusion volume to determine core serviceable opportunity. We are encouraged by our robust and growing pipeline with some near-term commercial opportunities. Moving to product development. Our initiatives are progressing well and will be drivers of near-term growth. I'm pleased to report that we launched our Phase 1 flow controller in Q2 ahead of schedule. Phase 2 flow control submission is expected by the first half of 2026 and will provide enhanced performance and expanded label indications that will expand our access to new patients in new markets. Our next-gen Pump development is on track with a 510K submission expected by Q4 of 2025 to Q1 of 2026. This pump will accommodate all available pre-filled syringes, will be vial and syringe compatible, and offer patients improved mobility and usability. We now expect to file a 510K for our new consumable sets in the second half of 2026. allowing us the time and opportunity to incorporate further market feedback. We do not expect this to have any negative impact on revenue figures in 2025 or 2026. We are prioritizing the pump development, a decision that has the potential to accelerate our international growth. Overall, I'm very pleased with the momentum we built in the first half of the year and remain confident in our ability to carry this trajectory through the remainder of 2025. We've established a strong foundation to execute across all of our growth pillars, and our teams continue to deliver steady, focused progress every day. With that, I'll turn the call over to Tom to walk through our financial results and share our updated 2025 guidance.