Ladies and gentlemen, greetings, and welcome to the KORU 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. 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 KORU Medical Systems, and Tom Adams, Chief Financial Officer. Earlier today, KORU Medical Systems released financial results for the third quarter ended September 30, 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 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 many 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 13, 2024, at approximately 4:30 p.m. EST. 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 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 line 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 the third consecutive quarter of double-digit revenue growth. We had very good performance across all 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 expectations 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 target, 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, expand internationally, and 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 IT 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 510(k) 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've 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 remained strong with 38% year-to-date growth, supported by several significant and sustainable growth drivers. IG growth outside of the US 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 a 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 Infusion Clinic opportunity, we were pleased to recently present favorable data about the use of KORU FreedomEdge pump versus manual syringe administration. I'll discuss this a bit further in an upcoming slide. And finally, we are also updating the timing of our 510(k) 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 be KORU's first entry into the Infusion Clinic setting, a significant milestone for the company. Again, we don't anticipate the delay to have a material impact on next year's revenue and remain committed to a timely submission as we work closely in collaboration with our pharmaceutical partner. 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 of 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 to 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 biologics, which we anticipate by the end of 2025 is potentially impactful given the large patient population. We continue to make meaningful progress with all our partners for our existing collaborations while simultaneously working to expand the pipeline beyond these 16 opportunities and add more drugs and indications to our prospective portfolio. And finally, in alignment with our oncology strategy, we are pleased to present at PODD, the Partnerships and Drug Delivery Conference, the results of a nursing preference study to assess administration of subcutaneous oncology biologic drugs using manual syringe administration versus the KORU FreedomEdge Infusion System. The manual syringe method is the standard of care for the approximate 2.5 million global oncology biologic infusions performed today. It requires a nurse to apply constant pressure on the 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 infusion centers. Our study presented at PODD in October, observed over 3,000 subcutaneous infusions of an oncology biologic with the KORU FreedomEdge 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 KORU 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 accumulated in 97% of the nurses within the study recommending the KORU FreedomEdge 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 KORU pumps may deliver substantial value to patients in nursing and infusion center settings, as this is the first of many steps in our journey to enter the oncology and clinic market. We are eager to continue our efforts to 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.

Thanks, Linda. We delivered strong performance with the third consecutive quarter of double-digit top-line revenue growth. Net revenues for the third quarter were $8.2 million, a 17% increase over the prior year period. Our domestic core revenues were $6.4 million, representing growth of 12% year-over-year and 10% year-to-date, and we continue to outpace the underlying IG market. This growth was driven by new patient starts and continued account penetration. Our international core business grew 5% year-over-year and 38% year-to-date with $1.1 million in quarterly revenue, driven by consumable growth in new and existing markets and strong performance in new geographies. As Linda mentioned, we believe customers have worked through the excess inventory purchased as a result of the earlier BSI notice that has since been resolved and will return to normal order patterns in Q4. Normalizing for this excess inventory, international core growth would have been approximately 24% in the quarter. Novel Therapies revenue totaled $600,000 and represented 276% growth year-over-year or a 46% growth year-to-date. This was driven by progress on NRE, non-recurring engineering services work for six collaborations compared to two in the prior year, as well as strong product sales in support of customer clinical trials. Moving on, we have consistently delivered gross margins above 60% through the year. And in the third quarter, we reported gross margins of 63.4%, representing a 140 basis point improvement over the prior year. This increase was driven by improved NRE margins resulting from bringing engineering and development activities in-house as well as an increase in ASPs from contractual price increases. The growth in gross margin was partially offset by changes in product sales mix. On the cash, as of September 30, we had a cash balance of $8.8 million, representing cash usage of $1.7 million in the quarter. This cash usage amount was in line with our expectations that we guided to in the second quarter call, knowing that we would be making certain investments in the quarter. Of this $1.7 million usage, the biggest contributors were a net loss of $800,000, excluding non-cash items, as well as $700,000 of investing activities, which were driven largely by capital purchases for our new consumables product line. Additionally, we had $200,000 of usage from working capital, which was primarily driven by higher inventory due to advancing our purchases for macroeconomic supply chain mitigations, such as the eastern seaboard dock strike and hurricanes in the Southern US. Looking ahead, our cash remains on track to reach cash flow breakeven in the fourth quarter, and we now anticipate ending the year with a cash balance of at least $8.8 million. Year-to-date, we've substantially reduced our cash burn with only $2.7 million of usage, a 60% improvement when compared to 2023. The key contributors, which I will get into more on the next slide are consistent improvements across the P&L and balance sheet for both the quarter and the full year. And as a reminder, we still have zero debt on our balance sheet and continue to have access to a $10 million long-term credit facility that is available to us as a reserve for potential strategic and growth investments. As I mentioned on the prior slide, on a year-to-date basis, we are performing well across the entire P&L and balance sheet. Our top line revenue growth has been impressive at 15% and the 560 basis points of margin expansion is a testament to the strong results our commercial and operations team have achieved. These improvements paired with disciplined operating expense management have driven operating leverage and led to a 20% improvement in lower reported net losses, as well as 29% and 60% improvements to our EPS and cash burn, respectively. We plan to continue this disciplined management in the fourth quarter and beyond as we stay focused on top line growth, improved leverage, cash flow breakeven in Q4, and operational cash flow positivity in 2025. Following our third quarter results, we are raising our revenue guidance for the second straight quarter and raising guidance across all three of our metrics. We are increasing our revenue growth target to a range of $32.750 million to $33.250 million or 15% to 17% growth from our prior range of $32 million to $32.5 million or 12% to 14% growth. We are increasing our gross margin guidance to 62% to 63% from our prior range of 61% to 62% as our manufacturing efficiencies and improved novel therapies profitability have been able to overcome the inflationary pressure we have seen in our supply chain. As for cash flow, we are increasing our ending cash balance to $8.8 million from $8 million after performing ahead of plan in revenue and gross margins as well as improvements in working capital. Given the stronger revenue performance, OpEx will finish slightly higher at $24.5 million to $25 million expense exclusive of stock comp versus $23.5 million to $24 million we have previously guided. We will reach cash flow breakeven in Q4 and will be cash flow positive, exclusive of capital expenditures for the full year of 2025.

Thanks, Tom. The third quarter was another great quarter of execution towards both our short and long-term goals. We once again grew double-digits and delivered strong performance in each of our businesses. We continue to be a market leader within our domestic core as we win new accounts, SCIG further penetrates the market, and we add to our recurring patient base. We are seeing accelerated growth in international core as we expand our presence in new geographies, and our novel therapies pipeline is robust, the diverse pipeline collaborations, and opportunities to add revenues in the near-term. All in all, I'm excited about our momentum as we expect to finish the year strong, setting us up for a solid 2025. I'd like to close by thanking the entire KORU team for their hard work as we continue on our journey toward creating the best drug delivery solutions for our customers and patients. Operator, you may now open the line for questions.

Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. The first question comes from Frank Takkinen from Lake Street Capital Markets. Please go ahead.

Great. Thanks for taking the questions and congrats on all the progress in the quarter. Linda, I was hoping we could start with a little bit more color on the next-generation pump being pushed out a little bit. Can you just give us a little bit of insight into what happened exactly with that? And then once that is submitted, can you give us kind of an overview of how you expect that to be cleared and then the launch plans thereafter?

Sure. The delay was primarily related to our consumables. We still plan to launch our new pump in early 2025. As we evaluated our overall product development, we recognized the challenges and decided to take extra time to ensure we gather all necessary data for our 510(k) submission. We are confident that we will meet our timeline in 2025, specifically by mid-year. Initially, we did not anticipate a broad launch in 2025, but rather a rollout towards the end of the year. Therefore, we do not expect any significant impact on our revenues. We remain confident in the studies and research we've conducted with patients and healthcare providers regarding the benefits of this product, which include greater convenience and comfort for patients. One positive outcome of the delayed launch is that it allows us to potentially launch the consumable alongside the pump simultaneously, which we believe will offer substantial advantages for our commercial team and our customers.

Okay. That's helpful. And then maybe shifting over to kind of the last piece you were talking about just the commercial team. Can you remind us where we stand with sales reps, territories? And then give us a taste for kind of hiring aspirations as you look forward?

Sure. So I just want to remind everyone, one of the greatest things about our business model is that a lot of our demand in the form of scripts for subcutaneous therapy are driven by pharmaceutical companies. So the reps there do the work with the docs to generate the script, which then goes to specialty pharmacies. Here in the US, we have expanded our overall commercial sales force, adding recently another new person internally. We have about five people in total in the US covering our key account base. About five of our customers purchase upwards of 60% of our volume, so we have fantastic relationships with them, which we focus on. Outside the US, we work with a very talented group of distributors, 26 in total, and our Chief Commercial Officer just led a very engaging distribution meeting last week internationally. Their comments are pretty fired up about the progress we're making and the work we're doing there, so we work closely with the distributor network outside the US.

Okay. That's helpful. And then maybe just for my last one, and I'm sure there's going to be some reluctance to speak to it with any great detail. But as we look towards the end of 2024, maybe give us some initial thoughts on 2025 about key items that are going to be driving growth. I think right now, the Street has something like 15% growth. Any reaction to that based on what your core business is doing and some of the new initiatives that are coming down the pipeline?

Yeah. So yeah, clearly, you pegged it right. I'm not going to comment on 2025. We are in the midst of putting all that together. In terms of specific numbers, we will be commenting on that in early 2025. What I would say is let's think about all the things that drive the company and the progress we're making. You see our US core business, which is the biggest part of our business, basically doubling their growth from where they were a year ago. A healthy IG market is helping, but the share gains that we're driving on a day-to-day basis are impressive to see. So that feels great when the biggest part of your business is now growing double digits. So kudos to that team. Second is obviously international. We continue to expand into new markets, opening up another new market this past quarter in Austria. Of course, we have the Japan launch, which we'll see most of the work happening there in 2025, along with some of the additional markets that we entered this year, including Turkey, etc. So just lots of momentum happening in our international business. Finally, Novel Therapies, I mentioned in the call, in my prepared comments that we're starting to see a lot more consistency in those revenues. We've got now a number of new collaborations, a number of products entering clinical trials, and an overall increased number. We believe that our overall Novel Therapies business should show some nice growth as well. Basically, you have all three parts of that portfolio performing at peak, some of them getting their best quarters of revenues that we've seen, and so that's a great way to end the year, and I'll repeat mix is still good as we think about 2025.

Got it. That's great. Thanks and congrats again.

Thank you.

Thank you. The next question comes from the line of Chase Knickerbocker from Craig-Hallum Capital Group. Please go ahead.

Good afternoon. Thank you for taking my questions. Linda, I want to start by asking both my questions upfront. I would like to understand the 510(k) filings for the two drugs we expect next year. Will these filings happen concurrently with the next-generation device? Is there a timeline we should consider for when those drug filings are made after the device filings? Do they need to be approved first, or can they be filed at the same time? Additionally, I would appreciate some general commentary on the SCIG market for the quarter and your expectations for Q4 regarding supply and market dynamics. What are you observing in the market so far? Thank you.

Right. All right, Chase. That was a lot. Thanks, first, on the congratulations on the quarter. So let me start with the two launches, and I'll piece them both parts. So the first launch next year that we're anticipating is an Infusion Clinic entry with a rare disease biologic. That, we had, coupled with our consumables launch, and so we anticipate those two coming fairly close hand-in-hand in terms of the filing for both would be submitted in parallel at the same time, and we expect that to occur by mid-2025. The oncology biologic, we are currently assessing plans, but we anticipate the launch of that product by the end of 2025, and that is not dependent on any of our current product line, new product assumptions, that one can be delivered with and we anticipate delivering it with our current legacy product platform that we have. The second part of the question was on the general market, the overall SCIg market, we feel great both here in the U.S. and internationally. I think if you look at the two biggest players in the market, Takeda and CSL, and you look at their reported results. They are reporting strong double-digit growth, which is great to see. We are tracking ahead overall. The market here in the U.S. is growing in the high single digits. We're performing ahead of that market, which we feel great about. We see all strong underlying generators for demand in that marketplace, so increasing movements to subcu therapy, overall strong supply in the marketplace, and overall increases in the number of patients being diagnosed every single quarter, which are all strong underlying drivers. That's a recurring patient base. They are chronic, and once they come into our pump and into our system, they are on the product for life. So overall, we feel very good about where we sit with that market. I think I got them all.

Thank you. The next question comes from the line of Anderson Shack from B. Riley Securities. Please go ahead.

Hi. This is Anderson on for Kyle. Congrats on the great quarter and thank you for taking our questions. So first, do you have any updates on the prefilled syringe adoption? Your core business growth outpaced the overall SCIg market again, is this the main driver here?

So first, prefilled syringe adoption continues to be, as we anticipated about 30% of the overall market now converted to a prefilled presentation. Overall, that is for us a vial to prefilled syringe; it's basically trading a customer from a vial to a prefilled syringe. I think the longer-term opportunity for us and for the total market is can prefills drive an increased number of patients on subcu therapy. I would say that the overall reasons for our increased market share, for our growth in the U.S. market are more about market share gains. Yes, some of it may have to do with the fact that we have great clinical training experts and reps that are able to support the conversion to prefills, but also just all of the day-to-day efforts we're doing with our key accounts. So hopefully, that answers the question on prefills.

Great. Thank you. And then how is commercialization in Japan progressing? Do you have any updates on your distributor and pharmaceutical company programs there?

What I would say is the team is doing a great job working with the pharmaceutical partners in that market. So both the two leading IG manufacturers, we are working in close collaboration with. We are still working out the final details of our distribution in that market, and we anticipate sales early in 2025. That is a top 10 IG market, so should be very positive for us.

Great. Thank you for taking my questions and congrats again. I'll jump back in the queue.

Thanks, Anderson.

Thank you. The next question comes from Caitlin Croning from Canaccord Genuity. Please go ahead.

Hi. Thanks for taking my questions and congrats on a great quarter. Just starting with the macro issues, Tom, I think you pointed to them with the hurricanes and the port strike. Is that something you guys are seeing an impact on or expecting potentially to see an impact on?

Hi, Caitlin. No impact on that. What we actually did during the quarter was our inventory amounts we purposely grew just in anticipation of those weather events as well as the dock strike. So we showed some growth in inventory on our balance sheet, which we expect to come back down here in the fourth quarter.

Got it. That makes sense. And then just any updates on the SCHOTT partnership and any early R&D synergies there?

Yes. So first, I would say that the teams are meeting regularly. I know that the team just met with them this past quarter at their headquarters in Europe. The again, I'll just highlight that the two advantages that we felt would come out of the partnership are starting to materialize. The first one is potential synergy and ensuring that the use of their prefilled syringe with our pump is optimized for the best patient experience. The second is collaboration and our pipeline opportunities. I know that we have progressed well on both of those fronts, so I'll remain excited about the potential for that partnership to position our devices as combined devices as the best in the marketplace, and secondly, to drive further collaborations in our novel therapies pipeline.

Great. Thanks for taking my questions.

Thanks, Caitlin.

As there are no further questions, I would now hand the conference over to Linda Tharby for her closing comments.

Just want to thank the KORU team again for a great third quarter, and thanks to all for listening in today.

Thank you.

Thanks, operator.

Thank you. The conference of KORU Medical System has now concluded. Thank you for your participation. You may now disconnect your lines.