KORU Medical Systems, Inc.

and Chairman, greetings and welcome to the Koro Medical Systems third quarter earnings conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star and zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Louisa Smith from Investor Relations. Please go ahead.

Thank you, Ryan, and good afternoon, everyone. Joining me on the call today are Linda Tharby, President and CEO of Cobru Medical Systems, and Tom Adams, Chief Financial Officer. Earlier today, Cobru released financial results for the third quarter ended September 30th, 2024. 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, 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 13th, 2024, 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 Sarby, President and CEO. Linda, please go ahead.

Thank you, Louisa. Good afternoon, everyone, and thank you for joining us today. I'll begin with commentary on our third quarter results and related business updates, followed by Tom, who will review our financials and 2024 guidance before we open the lineup for your questions. We are very pleased with our third quarter results, delivering strong top-line growth and increased operating leverage as we continue to progress on our near and long-term goals. Our third quarter revenues totaled $8.2 million, representing growth of 17% over the prior year period and marking third consecutive quarter of double-digit revenue growth. We had very good performance across all of our businesses, with our overall core business growing by double digits as we once again outpaced SCIG market growth and entered new geographic regions. Novel therapies had a strong quarter with an increased number of new collaborations and clinical trial orders compared to the prior year. We also delivered strong operational results with gross profit growing 19% year-over-year and gross margin improving 140 basis points to 63.4%. Our ending cash balance of $8.8 million was ahead of expectation and represents a 60% reduction in year-to-date cash usage as compared to the same period of 2023. Throughout the year, we have consistently delivered double-digit growth with a disciplined use of cash, which we anticipate to continue through the fourth quarter. As a result, we are pleased to be raising our revenue and gross margin guidance for the second time this year. In addition to increasing our year-end cash balance targets, Tom will review the details and assumptions surrounding our increased guidance in his commentary. Moving to the next slide, we continue to make progress in each pillar of our underlying growth strategy to protect and grow our domestic core SCIG business, to expand internationally, and to broaden our relevance with novel therapies. In domestic core, we saw double-digit growth of 12% and delivered the company's highest quarterly revenues to date. as we continue to outpace a healthy and growing SCIG market, which grew in the high single-digit range for the seventh consecutive quarter. We are consistently winning new patient starts and achieving share gains as subcutaneous administration expands across the overall IG market. We are executing well within the domestic core business and are investing in product innovation to drive growth and expand our current market share. We now expect a 510K submission for our next generation device to occur in mid 2025 rather than the fourth quarter of 2024. Please note that the change in timing of this submission will have no material impact on our 2025 revenues, as we had previously been anticipating a limited launch in late 2025. Moving to international, we saw 5% growth in the quarter, which excluding residual effects of the Q2 BSI stocking orders, international growth would have normalized to about 25%. We believe that our customers have worked through the last of this excess inventory, and ordering patterns will normalize going forward. Our international segment remains strong with 38% year-to-date growth, supported by several significant and sustainable growth drivers. IG growth outside of the U.S. remains robust, And as additional countries and regions expand their SCIG therapy indications, we expect to see a continued increase in our consumables volume, driven by a growing patient base and share gain. Additionally, we are leveraging further growth opportunities as our commercial team diligently works to expand our presence into new geographies, as well as by driving increased penetration in existing markets. Novel therapies had a very strong quarter, and we remain excited by the prospect of six commercial drug launches within our pipeline by 2026. This quarter's revenues represented growth of 276% over the prior year. Novel therapies revenues typically fluctuate by nature due to the timing of partnership projects, and with the increased diversity and number of collaborations as well as a steady progression in clinical trials. We expect more consistent revenues moving forward in this business. As it relates to the oncology and infusion clinic opportunity, we were pleased to recently present favorable data about the use of chorus regimen pump versus manual syringe administration. I'll discuss this a bit further in an upcoming slide. And finally, we're also updating the timing of our five-tenths case submission for a rare disease biologic from our original expectations, which is directly related to the delayed product submission that I discussed a few moments ago. We now anticipate this filing to happen sometime in 2025. The clearance for use with this drug will be important for us as it will grant CORU its first entry into the infusion clinic setting, a significant milestone for the company. Again, we don't anticipate the delay to have material impacts on next year's revenue and remain committed to a timely submission as we work closely in collaboration with our pharmaceutical partners. Moving to our pipeline slide, these represent each of our 16 current collaborations within novel therapies and the current stage of development for each. In total, these 16 collaborations cover a broad base of disease states and patients and we estimate that the drugs, devices, and expanded geographies covered here represent a total addressable market of about 2.7 billion across a global population of more than 2 million patients. Each of these collaborations represents the opportunity to add more drugs on our label and generate commercial revenues following their launch and or device clearance. Of the 16 collaborations in our pipeline, we have six either new drug, device, or geographic opportunities that are expected to launch by 2026 and serve as near-term catalysts for our business. Of these six potential launches, three are in our IG business, which we expect to drive share gains. The rare disease biologic in 2025 will be an expanded market entry to the infusion clinic, and our oncology biologic, which we anticipate by the end of 2025, is potentially impactful given the large patient population. We continue to make meaningful progress with all of our partners for our existing collaborations while simultaneously working to expand the pipeline beyond these 60 opportunities and add more drug indications to our prospective portfolio. And finally, in alignment with our ecology strategy, we are pleased to present at POD, the Partnerships in Drug Delivery Conference, the results of a nursing preference study to assess administration of subcutaneous oncology biologic drugs using manual syringe administration versus the core reagent edge infusion system. The manual syringe method is the standard care for the approximate 2.5 million global oncology biologic infusions performed today. It requires a nurse to apply constant pressure on a syringe for close to 10 minutes in order to deliver highly viscous drugs, causing potential pain and discomfort for both patients and nurses while simultaneously limiting nurse workflow and efficiency. This paired with the trend of an increased number of large volume oncology drugs transitioning to subcutaneous formulations creates a significant opportunity for an improved delivery method within the infusion centers. Our study, presented at POD in October, observed over 3,000 subcutaneous infusions of an oncology biologic with a core freedom edge system from a total of 33 nurses who had previously administered the same drug using the manual push method. The study yielded favorable results versus manual push with 97% of nurses reporting increased patient interaction, 81% experiencing less hand pain, 91% finding the Coral Pump easier to use and more time efficient, and 73% noting they observed less patient pain during their drug infusion. Each of these data points culminated in 97% of the nurses within the study recommending the Coral Freedom Edge system over the currently used manual push method with efficient use and less discomfort being the main reasons for choice. We are encouraged by these results, which add to the evidence that chloro pumps may deliver substantial value to patients and nurses in an infusion center setting. While this is the first of many steps in our journey to enter the oncology and clinic market, we are eager to continue our efforts, capitalize on this opportunity, and address the multiple pain points that could be solved with our pumps. Before I turn it over to Tom, I'll close by reiterating that we are very pleased with our results. which represented another quarter of consistent double-digit growth, improving operating leverage, and solid execution across the board. With this, we are confident in raising our outlook for the rest of the year and expect a strong end to 2024. I'll now turn the call over to Tom to discuss financial results and the specifics of our guidance increase.