Greetings, and welcome to the KORU Medical Systems Second Quarter 2024 Earnings 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. Thank you. You may begin.

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 second quarter ended June 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, August 7, 2024, at approximately 4:30 p.m. EST. Since then, the company may have made additional comments related to the topics discussed. Linda, please go ahead.

Thank you, Louisa. Good afternoon, everyone, and thank you for joining us today. I will begin with our second-quarter results and key business updates, followed by Tom, who will review our financials and 2024 guidance, before turning it back to me for closing comments. Following the prepared remarks, we will open the line for questions. In quarter two, we continued our strong momentum and delivered another quarter of record revenues as we executed on our 2024 milestones and progressed towards Vision 2026. Second-quarter revenues were $8.4 million, a 22% growth over the same period in 2023. Core business revenues grew 20% driven by SCIG market growth, share gains, and geographic expansion. Our Novel Therapies business, which serves as a business development pipeline for new drugs on our FREEDOM platform, also had a strong quarter as we progressed several of our collaborations closer to commercialization. This included successful feasibility results for an oncology biologic collaboration that we announced in Q1 and the entry into a Phase 3 trial for an expanded nephrology indication for an existing drug. Additionally, in June, we received the long-awaited regulatory clearance for our FreedomEdge infusion system for use in Japan, an important milestone in our international core business that will further expand our global reach and growth. From an operations standpoint, we continued our focused efforts on cash flow breakeven with progress on multiple fronts. Higher revenues combined with gross margins above 60% and further improvement in our operating efficiencies and working capital led to an overall reduction in net loss and brought us closer to our projected fourth-quarter cash flow breakeven. Progress against all of these milestones gives us confidence to raise our 2024 full-year revenue and gross margin guidance ranges and reaffirm our cash guidance. Before moving on to additional highlights, I'd also like to provide an update on the recent announcement about how we are refining our corporate organization structure. This past month, we announced the promotion of Chris Pazdan, our SVP of Operations, to the role of Chief Operating Officer. This new role brings together all of our key functions under one leader providing the focus and alignment needed to drive delivery on our pivotal product and program growth and operational targets. In his three years with KORU, Chris has proven himself as a transformative business leader, has consistently delivered results, and I'm confident he will continue to have tremendous impact on our success. Moving on to our key business results, I'll review highlights from each of our strategic growth pillars, protecting and growing our core domestic SCIg business, expanding internationally, and broadening our relevance with the addition of new labels in our Novel Therapies business. Within domestic core, we saw strong double-digit revenue growth of 14% over the prior year and continue to outpace a healthy SCIg market that’s growing mid to high-single-digits. We accomplished this through increased penetration in new and existing accounts with both pumps and consumables. We also saw double-digit end-user sales growth, an indication of strong customer demand for our products. The underlying IG market recorded a sixth quarter of sequential growth, indicating an increase in new patient starts. We continue to see our pharma partners drive prefilled syringe adoption, a more convenient option for patients, and the fastest-growing segment within SCIg. We expect to continue our momentum with a new product 510(k) submission in Q4 aimed at improving comfort and convenience for our patient base. Moving to international, we had a very strong quarter, finishing at 46% year-over-year growth excluding distributor stocking; which Tom will elaborate further on during his remarks. We saw growth in the plus 20% range. Strong performance was driven by underlying IG market growth, increased penetration in current markets, and new indications and expansion into new markets. As previously mentioned, we also received regulatory clearance for FreedomEdge in Japan, which will provide further upside in 2025 and beyond as we see continued subcutaneous market development. In our Novel Therapies business development efforts, we are focused on growing the number of drugs on our FREEDOM Infusion platform. We currently have 16 pipeline collaborations to date, including three signed this year. This quarter, we successfully passed feasibility for a prior announced commercialized oncology biologic. This is exciting as we anticipate that we will file a 510(k) for this product in 2025. In addition, we progressed to Phase 3 trials for a new nephrology indication for a currently marketed drug, and we have a rare disease biologic, which is in development phase and remains on track for a 510(k) submission by the end of the year. This will enable our first entry into infusion clinics, a prime new market for core growth. And finally, we also announced during the quarter an agreement with SCHOTT Pharma, the world leader in large-volume prefilled syringes, to optimize and grow the market for large-volume drug delivery. I want us to take a few moments to dive deeper into the U.S. SCIg market, our largest market where we hold the leadership position, and discuss what we see as continued future growth drivers. The graph illustrates the overall patient growth in IG, combining both IV and subcutaneous, as well as the growth in SCIg. A few notes to highlight: overall SCIg growth is projected in the mid to high single digits and is expected to increase in penetration, with SCIg growth outpacing the overall IG market growth. We have a recurring patient base of just over 30,000 patients in the U.S. Most of these patients have a chronic disease and will be on our pump for their lifetime, creating a large recurring revenue stream through the sale of consumables. In addition, there are multiple near-term catalysts that have the ability to expand our U.S. patient base. One of the primary opportunities we see is the market-wide shift towards SCIg as a preferred therapy. The IG pharmaceutical companies are making investments in their subcutaneous portfolios. A recent highlight from the quarter was the FDA approval of an expanded label for an SCIg drug, XEMBIFY, to include treatment-naive patients with primary immunodeficiency. The significance of this is that to date, the FDA has required the start of IV therapy prior to the start of subcutaneous therapy. This approval means the healthcare provider can put the patient directly on SCIg. In addition, the CIDP market, which counts for about 10% of our overall patient base, continues to grow with new diagnosis and a new delivery option PFS, which makes it more convenient for this high-volume dexterity-challenged patient to move to SCIg therapy. KORU’s emphasis on our key accounts and partnerships focuses on leadership in clinical practice and innovation in SCIg devices, which will continue to ensure we remain a preferred partner for customers and patients. Moving on to international, we are pleased with our 40% growth this quarter and wanted to provide some insight into what we see as a continued geographic expansion opportunity ahead of us. There's approximately $60 million of SCIg TAM in markets outside of the U.S., altogether representing a larger TAM than the U.S. market alone. We are currently marketed in 25 countries worldwide. But as you see in the graphic, our overall penetration into these markets has been relatively low. Our strategy is to continue to work with pharmaceutical companies and distribution partners on tailored device and patient programs to both increase our penetration in current markets and drive increased penetration into new SCIg markets. Our recent entry into Japan is one of these examples. We look forward to continuing our geographic expansion efforts and believe it represents an attractive opportunity for growth. The next slide represents our Novel Therapies pipeline. 16 collaborations in total, each one an opportunity to place a new drug on our label or expand existing drugs or innovations into new indications, which in total is a 2.1 million global patient population opportunity. The outlook highlights indicate the prior mentioned progress within the quarter, including the first clearance of FreedomEdge in Japan, progression of our oncology asset collaboration, and our expanded nephrology indication moving into a Phase 3 trial. In total, we now have six opportunities for new drugs to be cleared for use with the KORU platform by 2026, creating a path to a $10 million to $20 million of annualized commercial revenue potential at the end of 2026. We are very pleased with our progress we made this quarter on multiple fronts. Double-digit growth in our core business, continued progress in our Novel Therapies pipeline, and increased operating leverage through focused execution from our team. I will now turn the call over to Tom to review our financial results.

Thank you, Linda, and thanks to everyone joining us this afternoon. We are very pleased with our second quarter results as we saw another quarter of double-digit top-line growth and a record revenue-setting quarter. Net revenues for the second quarter were $8.4 million, a 22% increase compared to the prior year period. Our domestic core revenue grew 14% with net revenues of $6.2 million driven by higher consumable volumes as a result of new patient starts and share gains. Our international core business grew 46% year-over-year with revenues of $1.6 million driven by an improved IG supply versus the prior year, increased penetration in CIDP and SID-approved indications, and continued geographic expansion. The 46% growth rate for international core included about $300,000 of accelerated shipments as a result of residual effects from the BSI appeal that we discussed last quarter. Normalized growth excluding these orders was approximately 20%. Our Novel Therapies revenue, which we consider to be KORU pre-commercial launch collaboration revenue for services and clinical trial products, was $600,000, a 50% improvement compared to the prior year, driven by the completion of three clinical trial orders for our pipeline collaborations. We continue to diversify our customer base and pipeline collaborations as we work on additional agreements that will bolster our future core commercial business. Our first quarter gross margin improved to 65%, an 890 basis point increase compared to the prior year. As indicated on the bar graph on the right, the strong improvement was largely due to manufacturing efficiencies driven by the consolidation of our U.S. manufacturing sites. This marks the fourth consecutive quarter that we have achieved margins greater than 60%, and we continue to leverage operational excellence to identify and realize manufacturing improvements and efficiencies across our operations. Additionally, we have seen improved gross margins in Novel Therapies from our sales mix with higher levels of clinical trial orders, and in the U.S. core business, we recognize year-over-year increases in average selling price. I'd like to note that in the quarter, gross margin was positively impacted by a $140,000 inventory valuation adjustment that resulted in about 160 basis points of margin improvement that we do not expect to recur in the second half of the year. Moving on to cash, as of June 30, we had an ending cash balance of $10.5 million, representing cash usage of $300,000 in the quarter. The overall level of cash usage in the quarter was partially driven by net losses of $200,000, which excludes non-cash items of stock compensation, depreciation, and amortization. This was an improvement of $1.9 million over the prior year. In addition, we used $300,000 of cash to invest in capital equipment for our new production lines and we paid for our financing line for our D&O insurance. Partially offsetting these uses of cash were improvements in working capital of $300,000 with respect to our inventory levels, and we also brought down accounts receivable, driven by the same strength in the quarter. As we look ahead, our cash and cash flow targets remain on track and we are substantially reducing our cash burden since last year. In the first half of the year, we had cash usage of $1 million. We expect the second half cash usage to be higher than our first half with peak spending coming in Q3, driven by the majority of our capital investment outlay for our new production line and the related R&D project spending on innovation to bring new products to market. We remain confident that we will end the year with a greater than $8 million cash balance, as well as being cash flow breakeven in the fourth quarter. I would also like to remind everyone that the ending cash balance of at least $8 million is exclusive of our undrawn $10 million credit facility that is being reserved for strategic growth capital. Moving on to 2024 guidance, when we originally set our guidance, we noted some key growth drivers that would enable our success. Those being mid to high-single-digit SCIg market growth, three new Novel Therapies collaborations, and underlying prefilled syringe penetration of 20% to 25%. Now that we have two quarters behind us, we have delivered against our Novel Therapies milestones and are seeing a very healthy SCIg market with increasing prefilled syringe demand. We are raising our revenue and gross margin guidance. We expect the following for the remainder of the year: revenues of $32 million to $32.5 million, up from the prior range of $31.2 million to $30.2 million and representing 12% to 14% growth over the prior year. And please note, we mentioned in our commentary on international sales that we saw growth levels in the second quarter that we do not anticipate to be recurring. Our updated guidance accounts for international sales normalizing for the rest of the year. As for gross margins, we now expect the full-year gross margin to be between 61% and 62%. While we anticipate more pressure on margin from expanding into lower ASP regions, we continue to face inflationary pressure with our supply chain. We have managed to hold and improve our margin internally with additional manufacturing efficiencies and improved sales mix, margin, and Novel Therapies. Lastly, I mentioned before we expect to finish with an ending cash balance of more than $8 million, which includes approximately $23.5 million to $24 million in operating expenses. This ending balance is exclusive of stock compensation and includes the expectation that we will reach cash flow breakeven in the fourth quarter of 2024. Our credit facility reserve remains available to us for strategic growth opportunities but is not included in our estimates for the 2024 ending cash balance. With that, I will now turn the call back to Linda for closing remarks.

Thanks, Tom. This quarter we continued to execute on our business strategy, saw strong results as we did so, and we'll continue this focus in the back half. We grew double digits, outperforming a growing U.S. SCIg market, and expanded our international reach. Our Novel Therapies business development efforts are becoming increasingly relevant as multiple pipeline drugs approach approval for use on our platform, a critical inflection point for the business. We expect to see continued differentiation of KORU in our Freedom Infusion platform with a submission for a new product and a new drug by the end of 2024. We also made meaningful progress in our operating leverage towards our goal of cash flow breakeven by the end of the year. This strength across each of our strategic business areas generated record revenues and gives us the confidence to reiterate each of our 2024 milestones highlighted. These milestones are indicators of our progress towards our longer-term Vision 2026 goals. Our first-half momentum is encouraging as we continue in our journey to transform the company into a global leader in large-volume subcutaneous drug delivery. In closing, I'd like to thank everyone on the KORU Medical team for the hard work they do every day to create a superior patient experience and drive value for each of our stakeholders. Operator, I will now turn the call over for Q&A.

Thank you. We will now be conducting a question-and-answer session. First question we have is from Caitlin Croning of Canaccord Genuity. Please go ahead.

Hi, congrats on the great quarter, and thanks for taking the questions. Just to start, you mentioned prefilled syringe penetration being a driver of revenue guidance. Given you raised the revenue guidance, where is prefilled syringe penetration at this point? And jumping off of that, how is the progress on the 50 ml prefilled syringe launch earlier this year?

So, thanks for the congrats. We're excited by the progress this quarter. Specifically related to prefilled syringes, as you are aware, the leader in the U.S. market, CSL, has launched now their entire prefilled syringe platform, which is compatible with our KORU devices. The market uptake is getting stronger through Q2 as their intention is to move their entire platform over to prefilled syringes by the end of the year. So we anticipate, again for us, this is a one-on-one driver from vials to prefills where we're seeing that conversion. We think that the longer-term potential around prefilled syringes is the opportunity to bring more patients into the category as it's an easier format for the patient to use versus vials. So excited overall by our continued progress in the U.S. market, and prefilled syringes is a format change for us.

Got it. Okay. And congrats on the Japan clearance. Do you plan to pursue CUVITRU clearance in other geographies as well?

I'm sorry, I missed the back end of that question.

Do you plan to pursue CUVITRU clearance in other geographies other than Japan, because I believe that that's the first clearance you've had for that drug.

We are cleared for CUVITRU usage today, which is a specific drug. We are cleared for that drug, specifically in the U.S. Market and broadly internationally for that drug. So, the significance overall for Japan is just the entry into the Japan market. Yes, we did receive clearance with CUVITRU. We also received clearance, though, with CSL's Hizentra drug in that market, which accounts for about 95% of the overall Japanese market. So the significance for us obviously is Japan is a top 10 overall IG market, and we would anticipate that we will look for more significant approvals, specifically in Latin America and Asia Pacific for CUVITRU in the future.

Great. Thanks for taking the questions.

The next question we have is from Frank Takkinen of Lake Street Capital. Please go ahead.

Hey, this is Nelson Cox on for Frank. Thanks for taking the questions and great to see all the progress. I wanted to start with the expanded label for XEMBIFY allowing patients to go straight to SCIg. I heard you mentioned it in the prepared remarks, but can you just walk us through that a bit more and how we should think about this impacting your business in the market overall?

Sure. Great question, and thank you for the note of congratulations. So, all of the existing subcutaneous IG labels today call for healthcare providers to start the patient on an initial dose of IV therapy before progressing to SCIg therapy. Those labels have been in existence for well over a decade now. And so the significance of this is Grifols, with their XEMBIFY label, was the first drug manufacturer to go after a label that allowed them to go straight to SCIg. While this was becoming the standard of practice, it certainly was off-label usage. We anticipate that this will just make it a much easier progression to go directly to SCIg. If I had a crystal ball, I'd love to give you an idea of what that might look like. But I think we're just going to have to see what happens in the coming quarters, relative to healthcare practitioner use, and we will be sure to update you on that.

Perfect. And then, maybe just following up on Japan. Can you kind of talk about the strategy there and following the approval in July, how should we think about you guys entering that geography? And do you intend to go direct or will you need to do any other work to ensure access?

Yeah. So, we are still working to set up both our distributor and pharmaceutical company program. So we do have an existing distributor relationship, but all of the details, we're still working through. We see Japan as a significant market. We believe it'll be over time one of our top 10 markets for IG. We believe that it will largely be a consumables play initially, and this is largely an electronic pump market. So we will be focusing on the use of our consumables in that market and we don't see a big number in 2024, but see it adding about 5% to our overall growth number in 2025 for international.

Great. Thanks, guys and congrats again.

Thank you.

The next question we have is from Chase Knickerbocker of Craig Hallum Capital Group. Please go ahead.

Good afternoon. Thanks for taking the questions and I just want to pass along my congratulations as well. Maybe just first from me. Linda, if you had to say what's driving predominantly the outperformance here in the first half of the year, would you say it's more new patient starts or subcutaneous conversions from IV? Thanks.

So, I would say it's a combination. I mean, the performance of the overall subcutaneous IG market is driving new patient starts but certainly the growth in the front half, the performance in our international and domestic core businesses are doing incredibly well, as well as our business development efforts in Novel Therapies. So strength in all three is what we see driving the front half growth.

And maybe just on kind of the prefilled benefit that we could get from CSL canceling the vials. Do you think we've seen some of that benefit already, as part of the outperformance in the first half, maybe a benefit from some increased kind of prefilled conversion, or maybe just some thoughts there? Thanks.

Yeah, I think the prefilled launch is going per our internal plans to date. I think we will see more upside as we get into some of our new product innovations, one of them I mentioned coming towards the back half of the year, and the other one coming in 2025, which are tailored to benefit the prefilled users. So I think we'll see more then. And I think the first half is performing as per our expectations.

Yeah. So it sounds like overall SCIg market growth expectations are kind of unchanged. Things are going as you expected. Maybe just speak to guidance implying a little bit of a step down sequentially from here in revenue from the first half of the year into the second half. Should we think of this as kind of conservatism or is there some seasonality we should think about this year?

Yeah. So thank you. Great question. So, yes, Q3 traditionally we see a bit of a slowdown both here in the U.S. and internationally as vacations tend to slow down overall new patient starts, both from the healthcare provider perspective and from the patient perspective. The second thing is, as Tom mentioned to you, we had this $300,000 that was pulled into quarter two accelerated due to the prior issue with the BSI regulatory clearance, which we've since cleared. And then finally, we always have to consider timing of Novel Therapies revenues that is our intention to complete earlier, but working together with our pharmaceutical collaborations sometimes takes longer than we expected. So I think we look at all three of those things. And, of course, I wouldn't call it conservative, but I would say that we certainly hope that we have opportunities to outperform in the back half with both further international penetration and Novel Therapies collaboration timing.

Got it. And then just lastly for me, Linda. That was helpful. Can you share any plans you have regarding the commercialization of these new Novel Therapies? You will be launching them into the infusion clinics that provide patient-administered Novel Therapies, including the oncology asset and the rare disease treatment. Could you discuss how you plan to target that market and any early commercial strategies? Thanks.

Yeah. So, sure. With any of our launches on our label, the most important early partnership we have is with the pharmaceutical company itself. So we work closely with them on their launch plans and ensuring that we understand their targeted messaging, and we work with them to figure out where the right target and call points, whether that's a country or a specific clinic. So that's first, and we'll continue those efforts on those new drugs we talked about. Second, we have many of the specialty pharmacies that we work with today servicing the rare disease drug that I referenced, which we'll plan to file by the end of Q4. And then for oncology, we expect that we will work with a distributor specializing in oncology clinics for that market. But we're in the process of finalizing our commercialization plans for our launch with that drug. Thank you.

The next question we have is from an analyst of B. Riley Securities. Please go ahead.

Hi. This is Anderson on for Kyle. Congratulations on the great quarter and thank you for taking our questions. So first, do you have any updates on the potential expansion into Canada? I know there were some delays initially, but how is that study progressing and when should we expect to see approval here?

Yeah. So, we continue our discussions with the pharmaceutical partners in those markets. So that is progressing extremely well. The launch is really contingent upon our launch of a couple of new products, and we expect those to be completed in early 2025, so likely see a launch into Canada occur in that 2025 timeframe.

Okay. Great. Thank you. And then could you just give us some more color on the SCHOTT pharmaceutical collaboration? Will they be developing new therapies for use on the Freedom Pumps? And just how should we think about potential revenue contribution from this collaboration?

So first, I'll just reiterate that SCHOTT is the world's largest prefilled device manufacturer. So quite excited to announce this partnership. The partnership will focus on the use of our Freedom system platform and their prefilled syringes. We will focus on pipelines and looking at who we're working with jointly to ensure that the end customer, which is the pharmaceutical customer, is getting the best service of a combined device, which includes our Freedom platform and their prefilled device. We think there will be many advantages to the convenience and time required to infuse with prefilled syringes with this platform. We intend to do this at joint conferences and joint business calls, etc., with both companies. So too early to talk about commercial potential. We're just at the start of the collaboration, but I would expect to have more of an update on that in 2025.

Okay. Great. Thank you. That's all from us.

Ladies and gentlemen, we have reached the end of the question-and-answer session. And with that, we conclude today's conference call. Thank you for joining us. You may now disconnect your lines.