KORU Medical Systems, Inc.

Greetings and welcome to the Corrie Medical System's 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. If anyone should require operator assistance during the conference, please press star and then zero on your telephone keypad. 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 Coru Medical Systems, and Tom Adams, Chief Financial Officer. Earlier today, Coru Medical Systems released financial results for the second quarter and to 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. Eastern Time. 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 III 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 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 a promotion of Chris Pasden, 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 am 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 drugs on our label, our novel therapies business. Within domestic core, we saw a 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 a double-digit end-user sales growth, an indication of strong customer demand for our products. The underlying IG market recorded a six-quarter of sequential growth, indicating an increase in new patient starts. We continue to see our pharma partners drive pre-filter adoption, a more convenient option for patients, and the fastest-growing segment within SEIG. We expect to continue our momentum with a new product 510K 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 prior mentioned, we also received regulatory clearance for Freedom Edge in Japan that will provide further upside in 2025 and beyond as we see continued subcutaneous market development. In our novel therapy business development efforts, we are focused on growing the number of drugs on our Freedom Infusion platforms. 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 510K for this product in 2025. In addition, we progressed to phase three 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 510K submission by the end of the year. This will enable our first entry into infusion clinics, a prime new market for core root growth. And finally, we also announced during the quarter an agreement with Schott Pharma, the world leader in large volume pre-filled syringes, to optimize and grow the market for large volume drug deliveries. I wanted to take a few moments to dive deeper into the U.S. SCIG market, our largest market where we hold a 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 sub-Q, 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 it's 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 race 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 a 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, Zembify, to include treatment-naive patients with primary immunodeficiency. The significance of this is that to date, the FDA had 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. CORA's emphasis on our key accounts and partnerships, focus on leadership and clinical practice, and innovation in SCIG devices 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're 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 SEIG markets. Our recent entry to 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. Sixteen 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 yellow highlights indicate the prior mentioned progress within the quarter, including the first clearance of Freedom Edge in Japan, progression of our oncology asset collaboration, and our expanded nephrology indication moving into a phase three trial. In total, we now have six opportunities for new drugs to be cleared for use with the core platform by 2026, creating a path to $10 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 CORU pre-commercial launch collaboration revenue for services and clinical trial products, was $600,000, a 50% improvement compared to 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 prices. I'd like to note that in the quarter, gross margin was positively impacted by $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 the cash as of June 30th, 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, $300,000, with respect to our inventory levels, and we also brought down by a strong revenue quarter, which was partially offset by 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 a 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 started guidance, we noted some key key growth drivers that would enable our success, those being mid- to high-single-digit SCIG market growth, three new novel therapy collaborations, and underlying pre-filled 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 pre-filled 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 to $30.2 million, and representing 12% to 14% growth over 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 a full year gross margin 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 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 24. Our credit facility reserve remains available to us for strategic growth opportunities what is not included in our estimates for 2024 ending cash balance. With that, I will now turn the call back to Linda for closing remarks.

Thanks, Tom. This quarter, we continue 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 that we will 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 break even by end of 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 to a global leader in large volume subcutaneous drug delivery. In closing, I'd like to thank everyone on the Corps of 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 the question and answer session. If you would like to ask a question, please press star and then 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star and then 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. The first question we have is from Caitlin Cronin of Canaccord Genuity. Please go ahead.

Hi, congrats on the 3rd quarter and thanks for taking the questions. Just to start, you mentioned pre-filled syringe penetration being a driver of the revenue guidance. Given you raised the revenue guidance, where is pre-filled syringe penetration at this point? And jumping off of that, how is the progress on the 50 mil pre-filled syringe launch earlier this year?

So thanks for the congrats. We're excited by the progress this quarter. Specifically related to pre-filled syringes, as You are aware the leader in the U.S. market, which is CSL, has launched now their entire prefilled syringe platform, which is compatible with our core 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 pre-fills where we're seeing that conversion. We think that the longer-term potential around pre-filled 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 results. Continued progress in the U.S. market and pre-filled syringes is a format change for us.

Got it. Okay. And, you know, congrats on the Japan clearance. Do you plan to pursue QVIC2 clearance in other geographies as well?

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

Do you plan to pursue Cubitru clearance in other geographies other than Japan? Because I believe that that's the first clearance you've had for that drug.

For Cubitru specifically?

Mm-hmm.

Oh, or is it just more expanded geographies? Okay.

I was asking about that.

Sorry, Caitlin. Go ahead.

No, no, no. I mean, I was asking just about Cubitru specifically, since I don't believe you are cleared in other regions for that drug. But, I mean, if you want to talk about the broader pubic expansion as well, that's great.

We are cleared for Cubitru usage today, which is a KEDA drug. We are cleared for that drug specifically in the U.S. market and broadly internationally. for that drug. So the significance overall for the Japan is just the entry into the Japan market. Yes, we did receive clearance with Cubitru. We also received clearance though with CSL's Hyzentra drug in that market, which composed 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-Pac, for CubaTrue in the future.

Great. Thanks for taking the questions.

The next question we have is from Frank Takanan 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 Zimbify, allowing patients to go straight to SCIG. Heard you mention 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, sure. Great question, and thank you for the note of congratulations. So, all of the existing subcutaneous Ig labels today call for the healthcare provider 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 GRIFFELS with their Zembify 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. So 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 this will be, we are still working to set up both our distributor and pharmaceutical company programs. 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 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.

Ladies and gentlemen, just a reminder, if you would like to ask a question, you're welcome to press star and then one. The next question we have is from Chase Knickerbocker of Craig Callum 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 sub-Q 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 You know, certainly the growth in the front half, the performance in our international and our domestic core businesses are doing incredibly well, as well as, you know, our business development efforts and novel therapies. So strength in all three is what we see driving the front half growth.

And maybe just on kind of the pre-filled 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 kind of outperformance in the first half, maybe a benefit from some increased kind of pre-filled conversion? Or, you know, maybe just some thoughts there. Thanks.

Yeah, I think the pre-filled 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 that 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 pre-filled 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, you know, overall market growth expectations are kind of unchanged. You know, 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, you know, 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 NT collaboration time.

Got it. And then just last for me, Linda, that was helpful. Maybe speak to kind of any plans that you have from a commercialization perspective on these new novel therapies that are going to be launching into, you know, you guys are going to be launching into the infusion clinics here that deliver those patient-administered novel therapies, the oncology asset and the rare disease. Maybe just speak to kind of how you guys expect to kind of target that market, maybe early commercial plans. 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, many of the specialty pharmacies that we work with today service 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 who focuses and specializes in oncology clinics. for that market. But we're in the process of finalizing our commercialization plans for that drug launch.

For our launch with that drug. The drug is already there. Thank you. The next question we have is from Anderson Skok of Burali 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 in 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 shot 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, you know, first I'll just reiterate that Schott is the world's largest prefilled device manufacturer in the world, so quite excited to announce this partnership. The partnership will focus on the use of our Freedom System platform with their, you know, with their pre-filled 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 pre-filled device. We think there will be many advantages to the convenience and time required to infuse with pre-filled syringes with this platform. We intend to do this at joint conferences, joint business calls, et cetera, between the two 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 line.