KORU Medical Systems, Inc. (KRMD) Earnings Call Transcript & Summary

Good morning, everyone. We're excited to have you here for our second Investor Day and our first in 2 years. For those of you who have made the trip to beautiful Mahwah, New Jersey, welcome. I'd like to ask, how many of you were at our former site? Okay. So about 1/4 of the room. So this building, and we're not going to talk a lot today about the foundational investments we've made and the capabilities within it, but this building and the capabilities in it are really the springboard for everything we're going to talk about today. So when you are the world's leading large-volume subcutaneous delivery system, and you aspire to put many new pharmaceutical products onto that system, you need to do several things exceptionally well. First, you need to have a site where employees are excited to come to work every day. Check. Second, you need to have a site where your engineers and marketing teams can have beautiful lab spaces to work in so that they can dream and engineer the products of the future. We're going to show you some of those today. Check. Third, you need to have a site where your manufacturing teams can then take those products. They can pilot scale manufacture them; they can move them into manufacturing; and then distribute them to all of your customers. Check. And finally, when pharmaceutical companies are giving you their drug assets to put into your systems, their billion dollar assets, you need to be sure you have facility that can meet the exacting standards of those companies passing their audits, which are sometimes more exacting than the FDA's audits and you need to do that repeatedly. And we've done that now multiple times. So check. So thank you to all of our investors and analysts for your support today. We've been really hard at work and we're excited to share everything we progressed over the last couple of years. These are our forward-looking statements. So today, we're going to go into 4 areas: First, I want to talk about the broad opportunity that is subcutaneous drug delivery as we see a major movement from the hospital into the home. Second, we're going to talk about accelerating our revenue growth in both our core business in U.S. and International and also expanding with Novel Therapies. We're going to talk a lot about sustaining our differentiation through our product portfolio. You'll be able to touch and feel some of the new products that we're excited to be bringing to market. We're going to then talk about how does all of this relate to financial and other goals that we've set for the company. Along the way, we're going to hear from both the patient and an expert immunologist, and then we'll save lots of time for Q&A. So before I get started, to do anything that we've talked about today requires an experienced team of individuals who have the kind of attitude and drive that they take to their jobs every single day. And I'm excited to introduce both the team that will be presenting with me today and the team that helps do what we do every single day. These are an experienced team. When we built this team, we thought about 2 things. We are a medical device company, and we deal with pharmaceutical companies. So nearly every single person on this team has years of credibility in both spaces. So all of you know, Tom Adams, our Chief Financial Officer; Ken Miller, he's our newly appointed Chief Commercial Officer; Brian Case, our Chief Technology Officer; Chris Pazdan, our Senior Vice President of Operations, who is responsible for quality, regulatory and our project management office as well as operations; Brent Rutland who's bringing us -- you can give a little wave, Brent, who is bringing us world-class new capabilities in clinical and medical therapy; and Brian Herzog, who leads the group that assigns all of those collaborations relative to pharmaceutical companies who's got multiple years in dealing with pharmaceutical companies and drug delivery development. So let me begin with our opportunity. So today, we are the world's leading subcutaneous infusion system for delivery in the home. In a moment, you're going to hear from a patient about how we transform patients' lives with that delivery system. And we're going to talk about the journey not only in the home but also an emerging new opportunity in the clinic, which we're going to roll out today for the first time. So with that, let me spend a moment and introduce you to Christina. Christina is a KORU Medical patient for about 5 years. She was diagnosed with her condition after a series of about 10 to 15 infections where she had been to doctors multiple times, and her primary care physician finally said, "You've had over 10 infections in the course of this past year." She was in college at the time and they put her on IV therapy. She had to take a day out of her life. She got very sick and couldn't attend classes for 2, 3 days at a time. And so the very thing that she thought would make her better was actually not feeling so great in the first week. Her doctor at that point said, "I'm going to introduce you to a new system, which is a subcutaneous infusion system that you can do in the home." So we're going to hear her story with KORU Medical. We're going to hear it. We've rehearsed this a million times. But these things happen. So.

It was here.

Okay. Maybe I'll make sure that this is going to work.

Yes. And it did. [Presentation]

Hi. My name's Christina, and I'm a FREEDOM60 patient. With IVIg, you'll get a big dose, and then those will taper off until the next 3 weeks and then you get another big dose. So you get a lot of highs and lows. And in the highs, your body is trying to fight it so you get things like headaches. Really you almost feel like flu-like symptoms, sometimes for 2 or 3 days afterwards. Part of why I switched to subcutaneous immunoglobulin therapy was because you don't have these high highs and low lows because you get it once a week. I didn't have to go to an infusion center or a doctor's office. I am able to do it at home. Most subcu patients are able learn how to self-administer their medication. And you don't get those peaks and troughs with the IgG levels. But more importantly, it's so much easier to work into your life. So with the FREEDOM60 system, one, the pump is not this crank up, crank down. It is, you turn a button and it just loads itself. And I can literally just sit it down and not have to do anything with it. It works all by itself. It's also a system that I can take with me if I'm traveling. I just take the supplies that I have in the pump, put it in a bag and I'm able to take it on a plane, take it on a road trip. And I've actually done my infusion like during a road trip because I'm just kind of sitting there, and I could just let it infuse and by the time I get to wherever I was going, wherever I get to my destination, my infusion is done. Like, one, I made it through school. I made it through nursing school in the middle of a pandemic. But that just -- I had that determination. And being able to do my infusions on my own time, especially in school, it was around clinicals, around class, I was working nights as a tech at the hospital and I was -- never missed my infusions because they were just so easy for me to do at home. Yes, because this is more than just a company providing the device. They want to see that this device is improving our quality of life, in addition to our quantity of life because this is lifesaving, lifelong medication for patients with primary immunodeficiencies. So to know that they're even working on the future because I'll be on this for the rest of my life and the fact that they're just moving every day to try to make this process even just a little bit easier is amazing.

So, today, there are 30,000 Cristinas around the world and primarily, in one drug class, which is subcutaneous immunoglobulin. So now if I can get my slides back up, I'm going to take you into the broader opportunity that is subcutaneous delivery. I don't know if we can get that header off.

Yes. It's going to come off in a second.

Okay. So overall, we see a tremendous movement of health care from hospital to the home. Why is that occurring? Three reasons. First, you see with nursing shortages, the opportunity to move care into the home to be done directly by the patient saves costs. Second, you heard from Cristina and the many documented outcomes, the clinical efficacies are better with subcutaneous versus IV infusion. And finally, you hear from Christina, the patients prefer subcutaneous delivery, over 90% as studied in many different areas. So today, there are 15 launched drugs in subcutaneous drug therapy. The majority of those, as we talked about, are in immunoglobulins and administered in home. But there's another 1/2 which are subcutaneous and delivered within the [ play ] that we're going to talk about in a few moments. The pace of those launches has been expanding dramatically over the last 5 years. In addition, you see about 23 new drugs in Phase II and Phase III that are in large volume or above 10 mL, a space that KORU is the leader in today. So overall, what does this create for us? About a $2.5 billion addressable market; about 30% of that in our global SCIg business, which has lots of legs to grow as it's only about 20% penetrated today; and a very big opportunity with many new drugs coming to market in this area. So overall, what you see is a market that is growing at double digits, a market that has lots of legs for the future as we see many new drugs coming into the space. So we believe we're very well positioned to capitalize on this opportunity for 4 primary reasons: first of all, we see accelerating growth in our profitable Core business; we have the opportunity to expand that into many new drug platforms; third, we continue to differentiate with the new product portfolios I'll roll out today; and finally, we feel we have a pathway to profitability. So let's dive into this first area, accelerating growth in our Core business. Today, we have a leading U.S. share position with over 2 million patient infusions per year. As you heard from Christina, those patients are all chronic, meaning it's a recurring revenue base with today about 30,000 patients on the system. We have a low-cost go-to-market model. After we work with the pharmaceutical companies on the up-front process to get that drug on to our label, they do all of the hard work at the physician level to generate that demand for subcutaneous therapy. And the patient is serviced through specialty pharmacies. They do the hard work to ensure that the initial training is done by nurses in the home. And in that Core business, we had opportunities for expansion. Ken's going to talk about new countries. He'll talk about new markets and with our new product platforms. So it's a natural extension. If you're a pharmaceutical company and you are developing new drugs, you've got enough risk with about 18% from Phase I making it to the end of the pipeline. So the last thing you want to do is take a risk with your drug delivery device platform. That's why the KORU system is such a natural extension. So we have a clinic-ready commercial platform that is scalable on delivering 10 mLs up to 100 mLs, we can scale our platforms to all of those drug delivery devices. It's reimbursed so that you know you have a pathway to market. We have a robust pipeline. We've announced 15 collaborations to date with multiple new launches planned, potential launches by 2026, and we're going to talk about a new in-clinic opportunity and where we've seen 8 drugs launched since 2016. So overall, the commercial opportunity. You take $2.5 billion, you reduce it by the drug development risk, you reduce it by the pharma companies' risk, overall, we see an $80 million potential with what we've built to date, just what's in our close collaborations by 2031. In order to do that, you have to ensure you have a differentiated product portfolio. Today, prefills are one of the biggest new trends in drug delivery, and we are the only FDA-approved platform. We have multiple new innovations that we're going to show you today, and we've designed all of those around a patient-centric portfolio. And finally, we have a pathway to profitability. We appreciate this was a chosen investment strategy to invest in Novel Therapies to realize the potential for the company to be several hundred million dollars over time. So our pathway to profitability is dependent on a couple of things. Number one is our revenue outlook and projection. You'll see us ramp this over time as we introduce those new products and those new innovations, and those new drugs to market. We have a disciplined operating and capital expense program where we expect that our EBITDA margins will be positive by the end of next year and growing to plus 10% by 2026. So overall, you see a profitable Core business that has many attractive opportunities for growth, the opportunity to extend that leadership position into new drugs and new markets. We'll extend that with our product portfolio, and we'll show you today a pathway to profitability. So we take our commitments very seriously. I said the last time was a couple of years ago. So we just wanted to do a progress update and say how are we doing. So we promised 20% revenue CAGR. Today through 2023, we're at about 10% revenue CAGR. We achieved 19% last year. So the first year, we came out of the grades very strong. Obviously, this year with some timing in our Novel Therapies business and a little bit of a slower market in Ig, we get to this 10% space. We promised five Phase III trials. I'll talk you through some of those today. I'll talk you through when we expect report outs from some of those, but we're -- we have 2 in progress today. We promised 1 commercialized NT drug indication. That's what it's all about, commercializing these drugs. So we've completed 1 in '22, and we're actually ahead of track where we see 2 to 5 potential by 2026. We promised 8 new drugs and product indications, and we've now completed 4. And we promised a $1.3 billion TAM. And today, we see more than double that outlook. Ultimately, where does this land? A $60 million revenue by 2026 and several hundred million dollar company by 2031. So 2 years in, I'm very proud of the progress that we've made after a lot of hard work in this team. Now my clicker is not working. There we go. So I'm going to bring up Ken Miller, who is our new Chief Commercial Officer. I think Ken has an exciting story to tell about how we're going to elevate growth in our Core.

Thank you, Linda. Thank you. Good morning, everyone. How's everyone doing? Well, I'm going to turn it up a little bit and I'm going to turn it up a little bit. I'm really excited to take a few minutes to chat with you and discuss how we're going to accelerate growth and realize our Vision 26. So why don't we jump right into it? We've got 3 strategies. Well, first, let me just start by saying we've got a healthy and growing Core business. But we've got 3 strategies that are going to help us accelerate growth and realize our Vision 26. The first is that we're going to leverage the adoption of prefilled syringes. Second, we're going to maximize our innovation to differentiate our products from the competition and grow share. And third and last but not least, we're going to drive deeper penetration into our international markets. Let me take a moment to double-click on each of those. First of all, as it relates to PFS, prefilled syringes are preferred 97% of the time when patients are taking subcutaneous infusion therapy. Therefore, we're going to win new patient starts, both in the U.S. and internationally. This gives us the unique opportunity to convert competitive products to the KORU system because the KORU system is preferred 78% of the time when used with PFS over any other product. And last but not least, it gives us the opportunity to move into exciting new spaces like CIDP, where prefill syringes are the ideal platform to help those patients optimize their therapy. Let's talk about innovation. Linda and team have invested in refreshing our entire portfolio so that we can continue to differentiate ourselves from the competition. This gives us the unique opportunity to not only win here in the U.S., but also internationally, where we compete with electronic pumps. Our innovation platform has been specifically designed to be able to meet the needs of patients today and into the future. And the work that Brent and team are doing to generate clinical evidence to support our differentiation will truly help us to accelerate growth. And last but not least, is probably the area that I'm most excited about. I've only been here for about 30 days officially, but I spent 2 weeks in Europe, and I had an opportunity to travel all around Western Europe to meet with both our distributors as well as our key customers. And we've got a great business there and a great team. We've been growing double digits over the last couple of years, but there's a huge untapped population, even in the markets that we play in today. We are growing tremendously in markets like the Nordic region. We've got new opportunities in France and in Italy, but we are just starting to penetrate in those markets, as well as there are several large markets like Canada, Japan and Australia, where we don't play today, and we've got an opportunity to grow. I'll talk more about each one of these strategies as I roll through my presentation, but I wanted to give you the highlights that there are 3 clearly defined strategies that will propel our growth. We'll do this by leveraging commercial excellence as well as our collaboration with our pharma partners to deliver $45 million to $50 million by 2026 and realize that $60 million that Linda mentioned earlier. Well, let's step back and let's take a look at the market because a fast and healthy growing market truly help us to continue to grow. You guys know better than me that prior to the pandemic, the overall SCIg market was growing in the double digits. However, we got off to a little slower start in the market this year. In fact, the market started growing in the first quarter at around 3%, but we've seen continued accelerated growth quarter after quarter. As you can see depicted on the slide, in Q2, the SCIg market grew to about 4.5%. And here in Q3, it grew just shy of 8%. We've seen sequential continued growth across all menus, whether they be in the specific indications like PID and CIDP or in prefilled syringes. And we project that this growth will continue into Q4. In fact, we believe that the year will end with the SCIg market in the high single digits, let's say, 6% to 7% and continue into 2024 and beyond. We have put a relatively conservative market growth projection in our budget for 2024. We're targeting that about 6%, but there's a true opportunity for that to continue to grow way above that. But let me take a moment just to talk about CIDP as well as prefill syringes. First, CIDP. As you can see, it's one of the fastest-growing segments within SCIg, and it is a very unique opportunity for us. Patients that suffer from CIDP need a very large dose of Ig to be able to manage their condition. Therefore, each of the patients that we're able to acquire and bring on to our platform are valued at 2x versus a PID patient. And now prefilled syringes. Earlier, I HAD mentioned that one of our strategies is to leverage the adoption of prefilled syringes in the marketplace to continue to propel our growth. As you can see depicted here in this slide, PFS is the fastest-growing segment within SCIg. And that just enables us to continue to win those new patients and grow our share in the marketplace. So let's double-click on PFS. Because as you may know, we recently received FDA clearance. We are the first and only device that is cleared to be used in combination with the Hizentra 50 mL syringe, and this gives us the unique opportunity to get ahead of the competition and gain share of category because there is no other platform that is available to patients. Second, as I mentioned, the Freedom system is preferred 78% of the time over the competition when used in conjunction with PFS. But in addition to that, the Freedom system reduces the time and the complexity of managing SCIg when using a PFS. We'll leverage our partnership with our pharma partners to be able to change clinical practice and drive more accelerated adoption of PFS. And last but not least, and I don't want to steal Brian's thunder, our future portfolio of pumps are designed specifically to meet the needs of the growing PFS market, which we will tell you more about in a few months. So let's take a look at the numbers. Well, on the left-hand side, you see a graph, which takes a look at the historical penetration of PFS as well as our projection on where PFS is going to go. We project that PFS will penetrate the marketplace or be adopted to about 50% by the end of 2024 or into 2025. What are some of the major drivers of that adoption? Obviously, CSL getting the 50 mL PFS approved in the U.S. early next year. But the real fact of the matter is that greater than 70% of patients on SCIg require a dose greater than 50 milliliters. So this device is primed and ready to be adopted by the population. I mentioned earlier, nearly 80% of patients prefer the Freedom system when used with PFS. And last but not least, we feel confident that we can accelerate the growth of our share category in the U.S. with PFS to greater than 80% adoption of new patient starts. All in all, this is going to support our continued growth in '24, '25 and '26. Innovation. Linda and Tom have made the strategic decision to invest in innovation and refresh our entire portfolio to meet the growing needs of this population. So we'll be launching 3 new products over the next 2 years to meet those growing needs. We're really excited about the opportunity to meet the needs of both providers and patients as well as deliver on our promise of comfort, convenience at the right cost. I don't want to steal Brian's thunder because he's got a bunch of great stuff to share with you about our innovation. But we know that these 3 new innovative products will help us to continue to grow here in the U.S. as well as around the globe. But last but not least, only got 2 slides left, gang, and this is probably where I'm most excited because of the untapped potential in our international markets. As I mentioned, in the Nordic region, we are doing extremely well, whether it be in Copenhagen or in Finland. We have greater than 80% share in both of those areas. But there are several other Western Europe markets where we have less than that. And so we've got a huge opportunity to drive penetration in the markets in which we play in today in terms of winning new patient starts as well as converting from the competition. Brian will tell you a little more about it, but we clearly believe that we've got an advantage over ePumps. We've got no batteries, no alarms. It's easy to start like Christina said. And so we believe that we've got a value proposition at a cost of about 20% less than ePumps that will definitely meet the needs of the markets in Western Europe. I'm not going to hit on PFS anymore. Only thing that I'll highlight is the fact that in our international markets, we have very intimate relationships with all of our pharma partners in each local geography. We're collaborating on training, promotion as well as other go-to-market initiatives. Expanding into targeted adjacencies. While in Europe on my tour, I had the good fortune on visiting with some hospitals and seeing our system used in hematology and neurology where patients and nurses saw the advantage of the simplicity of our system, the comfort and ease of use. And so I know that there's a huge opportunity for us to move into these SID and CIDP markets in Europe and accelerate our growth. Expand geographic right? So we've only been playing primarily in the Western Europe market. But there are huge opportunities beyond that, in particular, in Canada and Australia, which are 2 of the 10 largest markets around the world as well as entry into Japan. In fact, we filed for regulatory clearance in Japan, and we anticipate to receive clearance in the first half of 2024, which will definitely help us to continue to grow outside of the U.S. So let's just take a quick look at the numbers. Again, that dark green bubble that you see on this slide is where we play today. We currently have about a 13% share outside of the U.S. Therefore, there is continued opportunity for us to continue to penetrate and grow. But again, in those markets where we don't play today, there's about a $10 million opportunity for us to bring our platform and system to be able to increase our share of category and profitability across the company. We believe that this expansion into international markets will allow us to double our revenue internationally over the next 3 years. Well, I'm really excited to be here. I know that we've got an opportunity to grow in the SCIg market, but I'd like to pass it back to Linda, so she can tell you how we're going to expand our targeted addressable market with Novel Therapies.

Great. Thank you, Ken. So great to have Ken at work. You probably see someone of his natural enthusiasm for the market. And what's very important in the work that he's doing with his team is ensuring that when we launch those new Novel Therapies drugs, we have a home and high market share positions in both the U.S. and internationally to bring those products into. Also our Head of U.S. Sales is here and I had a chance to catch up this morning. First question I asked him, guess. How's prefills going? So I just wanted to let you know that prefills will officially be launched in January of 2024. However, we have a lot of orders and backlog. So that's great news. And, Rob, keep going, and I'm sorry I took you out of the market today. So I'm going to talk now about -- go a little deeper on Novel Therapies and why we're so excited here. So several of you have asked me, why KORU? Why do people think about KORU when they're looking at drug delivery? So what I talked to you about before is that when you're taking a $1 billion asset that you have planned for the future, you want -- you have a lot of risk in that drug delivery development cycle. So you want to be sure that whatever partner you go with has a sustainable platform for the future and today presents 0 risk. That is what KORU offers. So today, we're a proven platform, 30,000 patients on the system. Patients want fast delivery. If you look at our delivery times relative to our competition's, we deliver at one of the fastest platforms today, about 10 mLs per minute. What does that relate to? Our patients can do their deliveries in anywhere from 10 minutes to up to about 30 minutes. We have broad compliance. We actually just purchased. I was hoping -- or didn't purchase but got access to 10 years of retrospective patient data on our SCIg users. So how are they adhering and how are they compliant? Brent promises me that data will be available. But that is great data. We know today, we believe our stick rates are well above 80%, that people don't switch off SCIg once they get on to it. And we know that our compliance rates to therapy, we believe are well above 70%, generally, compliance rates are somewhere in the 50% range. So very excited to get our compliance data. We offer a platform that is simple to use, mechanical system, it's low cost, and it's sustainable because it's reuseable. And finally, we can get these companies into the clinic within a matter of a month, if they want to use our current system. And if they want to customize it, we can get them into the clinic right away and then work on that customization over time. So once you get the product to market, that really is 10% of the battle. They worked 10 years to get the product to market, but the other 90% is ensuring that your partner has commercial access. So we're approved and marketed in 35 countries. We have a separate reimbursement code. So no need to worry about do I have to take more money out of the pocket to pay for this. It is fully reimbursed today. And finally, we have an established channel with several thousand nurses that are trained in our products. I'm not going to get into the next generation. Brian will, but we're excited. We've done a lot of patient research over the course of the last couple of years. We've been working hard, and we're excited. And we were able to preview our next generation at a recent show and are very excited. It's generated a lot of new interest in KORU and where we're going. So I talked earlier about those 23 new drugs in development. And this slide is exciting in a lot of different ways. First, just looking from left to right here. You see that it's not just immunology, but there are many other new drugs that are looking at subcutaneous development. The exciting part is that only 2 of the 23 are IV-to-subcu formulation. What does that mean? That 21 drugs are thinking their first format will be subcutaneous only. That's a major shift where people always launched an IV and then went to subcu. Second, we see that if I looked at the total platform between 10 and 20 mL, which is our sweet spot, plenty of new opportunities in that space. Phase III represents close to 60%. What does that mean for all of you? It means a faster-to-market opportunity for us. And the last column really shows that a substantial amount of those assets are in non-Ig spaces. So incredible opportunities for us outside of Ig. Now this slide, hopefully, all of you are becoming familiar with. But what's really important to us because of the overall failure rate and new drug collaborations is that we get as many shots on goal as possible. So overall, today, we talked about 15 collaborations in total. We've got 18 new opportunities that we're working on outside of that. And what has all of that done? It's expanded our overall TAM from that $480 million to about $2.5 billion. Now these are in different phases. You see here in the bottom, Phase II and Phase III. Most of our IG assets involved are all in Phase III development. So it's projecting a strong Core business because we're working with all of those pharma companies on their assets for tomorrow. And then we also have many new spaces to go into. What I've never done is taken you through so how does this amount to a revenue number. So let me walk you through 3 examples from that pipeline. First is a hematology asset. This one, I think I can talk about. It's a company called Kira Pharmaceuticals. Most of our companies do not want us to talk because they have no desire to have anybody know what they're working on outside of their publicly reported clinical trials. They'll be reporting out on interim results from their Phase II next week at a major hematology conference. This is a very big patient population. That's how we generate our TAMs. But then we take that, we look at the number of infusions per year, we discount it for percentage diagnosed. We discount it for the percentage treated with the drug, and we discount it for the overall drug development risk. Today, these are at full potential of -- all 3 of these assets made it to market. So what does peak mean? Peak is generally 5 years after the drug launch. So this one in '27, we would see that peak in '32, but that's a $40 million asset. Endocrinology, this company, I can't name, but they are entering their Phase III trials early next year. This is a drug that serves a very rare patient population as the only drug available to date, the only help for the patients suffering from this condition. They also do about 2 infusions per week. We estimate about 600,000 infusions per year. And this one will hit their peak year in that '31 time frame or about $11 million in opportunity. And this final one is an interesting story. I haven't yet announced this collaboration because we generally start working with these companies, and I've said to the team, we now need to get the agreement signed and documented before we're actually exchanging product. But these legal entities within pharma take a long time to come. So I hope to be announcing this one soon. But this is a neurology product. It's a launched product. It's actually a product that's used in the clinic today for nurse administration. 50,000 patients, and they do 24 infusions per year. Again, all of these are chronic conditions. We estimate about 200,000 infusions per year and the overall potential of that one is about $4 million. So as we think about this, you see many new sources of revenue gain for the company here. Between '23 and '25, it will continue to be driven by immunology and neurologies or SCIg indications, through geographic expansion, through expanded indications of our partner, and we have one nephrology asset that we believe will make it to market prior to that. But you see as that pipeline, as time goes on, time becomes our best friend, you see the multiple new opportunities that we could have for new drug launches. So what does that mean? If we take that and we risk reduce it for many of those things I talked about earlier, take the total patient population, reduce it for number diagnosed, reduce it for overall share of that pharmaceutical company, we get to about $80 million revenue potential by 2031. I think what's important to note is that we've been at this for 2 years, and we've created a potential here that is more than close to triple the size of the company that we are today. And when they get to peak year revenues, it's about a $250 million commercial opportunity. So that is with -- everything I just talked about was for our current collaborations, which are for drug therapies that are delivered subcutaneously in the home. This slide shows us 15 indications I talked about earlier. We love to see a green on here because all of these are the KORU assets today. We see today, there are 2 competitive assets Enable, which was just launched, and we share that with Empaveli. We have the whole franchise globally, and they lead -- or projected to lead here in the U.S. And then Furoscix, which is outside of our administration range, but that is a West pharmaceutical. So remember, we're 10 mLs and above. So in-clinic nurse administration, what does that mean? So a patient -- and these are markets we don't serve today. But what you see is the overall pace of innovation between '28 (sic) [ 2018 ] and '23, you see a lot of new drugs going in. And you see a lot of gray boxes. So within the movement from the hospital to the home, there's an infusion clinic. In those infusion clinics, there are nurses that are administering therapy and all of these ones in gray have one thing in common. Most of them, 95% of them except one are oncology assets. Second is they use a manual push-syringe method. So when the drug delivery companies were in their clinical phases, so think about this anywhere from 2016 all the way up to 2020 before they launched these drugs, what product did they have available, was a manual push method, so before KORU really began this journey for Novel Therapies and getting all of these on here. So a manual push method, I'm going to talk to. We've been doing some clinical research in Europe, and I'll talk you through what these look like. So today, we see this as about a $40 million total opportunity. If we realistically look at that and say we're not going to get every clinic, we're not going to get every drug, that's about a $10 million for KORU opportunity. So what happens today is a nurse has to take 2 to 6 pounds of force, and we're going to let you feel what 2 to 6 pounds of force feels like today. So they're taking this, they're pushing this through a manual syringe, they're trying to do it evenly at an even dose so that the patient is getting the dose in the right way, and it takes them about 5 to 7 minutes. Doesn't feel like a lot of time, but think about what that's like to try and push this in over 5 to 7 minutes. So what we've seen in our initial trial sites is that there are tremendous problems with nursing satisfaction. So they struggle from a dexterity perspective with doing multiple injections per day. Many of them report pain and tiredness of the hand in trying to do that. The push is inconsistent, so are these drugs being delivered in a way that delivers them at an even flow rate? And it's difficult to engage the patient while they're pushing. What they're real trying to do is make sure the patient is okay, is everything okay. And what they're more concerned about is, am I doing this administration properly. For patients, we put them back on manual push, and they ask to go back to our FreedomEdge system. So for them, they had fewer reported pain incidents with manual push. So today, all of these drugs are opportunities. They're approved drugs, which is fantastic. There's no risk in those approved drugs. So what we have to do, obviously, to get these approved, is we need an FDA approval. Today, any work we do is an off-label indication, and we can't have Rob and his team go out and commercially switch those as much as possible. We need to show some clinical proof because a manual push method is -- our system will be a little bit more expensive. So we need to show the clinical proof. And obviously, we need to build a commercial opportunity -- commercial capability to get there. But we see a tremendous opportunity for these in-clinic drugs. Will they make it to the home over time? We're not worried about that. We have a system today that we can administer these drugs in [indiscernible]. So what are our milestones that we think about for Novel Therapies? First of all, increasing that overall pipeline. We showed you 23 assets that was a new -- we subscribe to a database to get those assets, but ensuring that we focus on increasing that pipeline, shots on goal is incredibly important to us. Second is closing those Phase III assets we talked about in in-home administration and then focused on the in-clinic opportunities. And finally, increasing our pre-commercial and commercial revenues through execution on our innovation agenda. So we expect, as I said, 2 to 5 commercialized drugs. We have a couple of those that we know about today, the one that's already launched that I talked about, and we're expecting one of our 3 Phase III trials to make it to market. And then we're expecting of those in-clinic oncology that we'll get 3 of those assets, so not quite 1/2 of those across the line. Novel Therapies is a business that by nature because clinical trials take a little longer, we're projecting today about a $10 million revenue opportunity by 2026. And then the commercial potential beyond that with just what we have signed today at about $80 million. So in order to do all of what we talked about for Novel Therapies, I hope you feel as I do, tremendous area of progress for the company that we've made with overall drugs in development and getting those on to our platform. In order to keep that interest over time, you need to show pharma companies that you're investing in your future. So with that, I'm going to turn it over to Brian who's going to talk about our product portfolio.

Thank you. Good afternoon, everybody. My name is Brian Case, Chief Technology Officer. All right. So we've been at this for about an hour. So the human body's good for a little bit less than an hour sitting down, so we'll go a little bit off script. I'm going to ask you guys really quick that they take a step up, I want you guys, quick little stretch. Please humor me. I want you guys ready and excited about this. All right. Now we're ready. Thank you very much. All right. Now we're in. We got this. So again, very excited to have the opportunity to speak to you today. So thank you. Putting the patient first always, it's a fundamental belief that we have that drives our mission to be experts in the design, development and manufacturing and the patient-centric drug delivery systems. Our patients deserve that commitment and our pharma partners expect it. That is the reason we've aggressively invested in R&D 5x over the last 5 years to deliver on our innovation, to drive market expansion and to strengthen our competitiveness. As part of that investment, we've built best-in-class R&D procedures, which have been recognized by regulatory bodies and our pharma partners. In our most recent 50 mL PFS indication 510(k) approval, we were able to do that in a very impressive 119 days. So it was wonderful to get recognized by the FDA on the great work that we're doing. We have also built out the talent into the organization. We built expertise in engineering, quality, regulatory and medical affairs. This year, we will produce more clinical evidence on our product than we ever did in the history of the company. We presented that information in posters and white papers at key conferences. So thank you, Brent. By bringing that talent in-house, we can reduce reliance on our outside partners, and then we can also reduce the development cost. We've also been aggressively investing in protecting our intellectual property. Right now, we have over 70 global patents globally and that we are in the process of -- with 20 patent applications that are pending with more to come with our innovations. We are providing customer-focused solutions to accelerate product growth, and we're doing this in 3 key innovation areas: comfort, convenience and connected. We've used the latest human factors and usability techniques to better understand the patient journey. We've done multiple interviews with patients like Christina to better understand how they're feeling, what they're thinking and what they're doing throughout the infusion process. This allows us the opportunity to better understand areas for improvement and where we can make that patient experience better. So the 3 areas that we focused on comfort, what the patient's looking to do is to reduce patient and anxiety. They're looking for user-friendly designs. So when you think of certain patient conditions or their dexterity challenges, like patients with CIDP or other comorbidities, they have strength issues, so they're worried about that. On the convenience side, they're looking at fewer steps, minimizing the complexity of the procedure. Reducing the potential for error. What's amazing, that's something that causes a lot of patient anxiety is the concern that they've done something right. And then most patients, surprisingly, not all, are looking for faster infusion times. On the connectivity side, this is a combination of patient and doctor. They're looking for efficient ways to collect procedural data and do analysis. They want early identification of potential problems. And then they want to also be able to have that data to improve their clinical decision making. We've used all of that patient research to reengineer every part of our infusion system to make the best solution for patients and providers. 85% of our patients want a more comfortable needle. So we've made -- we've reduced the needle size. We've improved the needle geometry. We developed a proprietary lubrication technique. And as we get closer to launch, I'll be very excited to present some of the exceptional data that we've been able to collect on the improvement in this performance. When you think about reducing the number of steps or the complexity of the steps, we've reengineered the connectors and the caps to make them more ergonomic for those dexterity challenged patients. We also looked at improving or added color codings to the connectors to make sure that we -- the patient doesn't do any misassemblies and reduces the patient anxiety. We've also integrated the adhesive into the needles, the butterfly needle as this reduces the complexity of placing the needle. And then what we've also done is optimize the infusion set offerings. And what we're also going to do is provide a simplified tool that will help them select the optimal infusion set to get the fastest procedure time. Our studies suggest that they can see a reduction of over 20 minutes in the procedure time with the optimized infusion set. Our latest patient study, I'm very proud of this statistic, when you look at it, said 100 patient surveyed believe that the new infusion set would improve their experience, 100%. When we designed this infusion set, we made sure that it was truly a platform solution and that it will be easily customized for our Novel Therapy patients. Our pioneered subcutaneous delivery into the home with our FREEDOM60 and our FreedomEdge. Both of those pumps are simple, easy to use and use a mechanical constant-force spring. When patients are doing their delivery, they can -- the place in which they do their injection site, there is a different amount of medication will be absorbed at different rates. So again, that's dependent on the patient. That's also dependent on the infusion site. So there can be situations where they'll see buildup and pressure at that infusion site. So what's elegant about our solution in our constant-force spring is that we don't push harder. We don't increase the pressure at the site. Unlike electronic pumps that are more expensive and more complicated, when they see a situation where the tissue builds up in pressure, they push hard. And so it generates more and more pressure, which makes the procedure uncomfortable and also has the potential for site leakages. So based on this fact, what we're doing with our next-generation SCIg pump is we're building on that constant-force spring technology. We also are big believers in the benefit that prefill syringes can bring with up to 80% reduction in the drug preparation step. As Linda mentioned, we have demos set up. We'll give you the opportunity what it's like to take a high viscus solution, take it from a vial and pull it. We'll let you guys experience that. And when you do that, I want you to think about those patients that have dexterity challenges and also have strength challenges and understand that patient experience. So with our new Ig pump, it will be a single pump then will be able to accommodate a variety of doses and all different syringe options, and will be able to maintain the equivalent flow with just one infusion set. So that's the magic. It's being able to maintain that equivalent flow with that one infusion set. And we're going to do that automatically. There will be no -- from a patient standpoint, all they will need to do is take any of their different syringes, place it in the pump, close the lid and they're ready to go. No complicated programming step, no complicated drug transfer step. We believe that with the improvement of this patient experience, there is opportunity to bring more treatments into the home and to potentially improve patient compliance. Also by having one pump, we believe we will reduce the cost and complexity to the specialty pharmacy by minimizing their inventory and also reducing their training. As Linda said, novel therapy is our biggest opportunity. We have a broad range of an existing product portfolio that can be clinic ready quickly and help our pharma partners get faster time to market. We are also building out a future novel therapy platform that will focus on 3 key areas: baggage and accessories, pumps and infusions. And this will all vary based on the form of partner and also their patient needs. When you think of packaging accessories, for patient convenience, we're going to provide a patient procedure kit. For the pharma partners that have not moved to prefill syringe yet, we're going to offer a vial transfer device that will simplify that complicated drug transfer step. For the pumps, we're going to offer a simple small, customizable pump that would be specific to a particular drug indication, will have the ability to add tracking sensors and connectivity. On the infusion side, as I mentioned, it's a platform solution, so we can easily customize it based on the drug characteristics, and it will be compatible with our new needle inserter for those to minimize or hiding the needle and also to automate the placement of the needle. And this will help patients that experience needle phobia or needle dread. We're very excited about all these products, but we also want to make sure that we're helping our pharma partners meet their sustainability goals. So when you look at our portfolio, the majority of our products are reusable. We believe the best way to be sustainable is to be reusable. So our pipeline of product solutions support our objectives. They increase market penetration, they help us gain market share and they accelerate growth. When you look at our SCIg product portfolio, we are extremely excited about the recent approval for a 50 mL and getting that to market. As Ken mentioned, 70% of the patients have doses that are higher than 50 mL. This opens up an enormous patient population to benefit from prefilled syringes. We are also building a best-in-class infusion set focused on patient comfort and convenience. We have a revolutionary Ig pump that will be one pump for any dose, any syringe size that will automatically select it without any programming and it will maintain that equivalent flow rate with one infusion set. On the Novel Therapy side, we will have customized best-in-class infusion sets that will be compatible with our needle inserter. And as I mentioned on the novel therapy pump, simple, easy to use, highly customizable to one particular drug class and that will have the capability of adding connectivity. So we're very excited about getting these products to market. We're very excited about getting these into our patient hands so they can experience the benefit of our innovations. With that, we're going to try another video. So I'm going to introduce Bob Geng, he is a certified immunologist and the associated Professor at University of California and San Diego. [Presentation]

The overwhelming response that I get from patients, my patients, regarding their experience with the KORU infusion pump and the entire subcu infusion system has been overwhelmingly positive. And it has to do with several major principles. And these principles are simplicity, tolerability as well as affordability. I think these are critical elements. It's not an electronic pump, and because of that, the cost of the pump is much lower than compared to the electronic pumps now in the market. And I think for a lot of patients, that matters because many patients' insurances will not cover the electronic pumps. Two, is that because of the simplicity nature that it is really based on a wind-up spring technology, that it's really not going to be something that someone can really mess up on, that there's not a whole lot of buttons that are associated, there's not a whole lot of different settings that you can make a mistake on and I think the simplicity of this is the elegance and the patients can be able to load the syringe on and be able to set the apparatus in motion and not have to worry about it. We are giving the patients a really tolerable experience that my patients are not complaining of excessive amounts of swelling or pain in the area during infusion because the principle of dynamic equilibrium that's achieved through the KORU pump system. And I think that this is, in some ways, intuitive as well because if you enjoy the experience, if it's not overly burdensome, then you're going to want to be able to repeat it. If it's a process that's going to be onerous and something that causes discomfort or dislike and a patient that's non-intuitive for the patient, then they're most likely not going to want to repeat it. And if you have that desire to not want to repeat it, their compliance is going to fall. And that's where KORU really shines because it's able to create and really pioneer because it was the first one that came out with this system for subcutaneous delivery, they really pioneered something that's tolerable and be able to innovate towards it and design something that's cost-effective and provides patients with a pleasant experience to minimize the burden of treatment as much as possible in order to show that adherence approach. I think it's really the ingenuity of KORU that is going to drive not just your company but also the entire field forwards. And I think that what is spearheading, what is driving the direction of that innovation and what's driving the direction of the innovation is a patient-centric trajectory. I think that's really important that ultimately, we're looking at how do we improve the patient experience. These things are going to translate into better adherence to people who are already on therapy, but also help to relieve some of the concerns in patients who are in the contemplative stages of going to subcutaneous drug delivery because they may be concerned about the potential of what does it mean that I have to do it myself? Is this going to increase the burden of treatment for me? Is this going to make my life more difficult? What if I'm not doing it right? What if I'm causing myself more pain? So all these different elements are trying to improve the infusion experience, trying to simplify the process. So through simplicity, we're trying to achieve greater tolerability. I think the future of subcutaneous drug delivery is bright and I that the direction that we're moving is going to be further and further away from IV delivery. Because at the end of the day, it's very hard to achieving this access for a lot of individuals. So people don't want to have to rely on the infusion center. We don't want to have to rely on infusion nurses. And we don't have to want to rely on patients making sure that they can always find good venous access every single time. The obvious answer is that we have to go towards an easier mode of delivery.

Clearly, we're spending a lot more on innovation than we are on IT technology here and it's [indiscernible]. So I'm Tom Adams, I'm the CFO of the company. And I'm here to put a bow on a lot of these great presentations that were just given over the last hour and change, remembering that our OUS U.S. business is a strong recurring profitable business and our Novel Therapies business is one of our -- a new business over the last 1.5 years, which is a lot of promising, has a huge promising future and potential. So the first slide that I'd like to show here is our pathway to $60 million. So when you look at this slide here, $28.3 million is our latest estimate for this year, and we have a clear pathway to grow to $60 million plus, inclusive of some opportunities that I'll be discussing here in just a few moments. When you look at the first box here, we go from left to right, if you look at the U.S. Core business of around $13 million to $17 million, you can think about that in 4 buckets: market growth, 6%, 8%, 10% over the 3-year period; the prefill syringe adoption that Ken mentioned; our new product introductions that we will be launching between consumables and pumps; and then finally, the SCIg formulations that our Ig partners will be launching over the next 3 years. From an OUS perspective, you see the growth rate of $6 million to $8 million here. That is also market growth of 5% as well as expansion. Expansion, expansion, expansion's what you heard in Ken's presentation within our key EU markets and then globally, it's in new markets, as well as prefill adoption of working with our pharmaceutical partners overseas in our European markets. Novel Therapies. Novel Therapies will primarily be driven in the next 3 years by our NRE activities, our nonrecurring engineering services that we provide today as well as clinical trial products that we deliver to our pharmaceutical partners. That will be the bulk of that money as well as one or two commercial launches that Linda mentioned on our pipeline slide occurring between 2025 and 2026 time line. And then finally, in the last bucket is the really exciting opportunity of the infusion clinics. And as Linda mentioned, we see a $40 million opportunity in that space. And we expect to benefit in that space over the next 3 years by getting more drugs on our labels. And helping the clinics out going from a manual push to transitioning to a pump inside the clinics. So again, about $31 million plus, more than doubling our sales from where we are today over the next 3-year period. As we step into gross margin and we look at our profile today, we are at about a 58% to 60% gross margin that we expect on the full year. That's about a 400 basis point improvement from where we landed in 2022. You can see a nice projection of gross margin improvements through the 3-year period. And really, what it's going to come down to, to get these gross margin improvements are continuing to look at our manufacturing footprint, take advantage of outsourcing opportunities where we see fit and we see a lower-cost location. Secondly, within our NRE space, our nonrecurring engineering service, we spent a lot of money bringing in the capabilities that Brian just mentioned in-house. That's going to give us a nice margin improvement on our NRE efforts as we service those clients with our own skill and our own capabilities versus spending a lot more money outside with consultants. Productivity and efficiency gains. We have 2 plants today. We have one in Mahwah, where we manufacture our pumps and consumables and then we also have our third-party contract manufacturers. We will continue to work with these, with our manufacturing folks and ensure productivity and efficiency gains to also improve our margin over the 3-year period. And then finally, with all these new products and the new features that we are launching, we do expect to see premiums in the marketplace and improve our ASPs with those new consumable sets and new pump delivery systems. Moving over to a disciplined investment strategy. So this slide is all about where we were and where we're going and talking about operating leverage. So in 2023 and even before 2023, we spent a lot of our investments, and we chose to spend a lot of our investments to invest back into the business. And that was in new facilities, new manufacturing spaces, new R&D labs to support Novel Therapies and those are pharmaceutical partners as well as G&A, right, new leadership teams, and new capabilities to bring in-house to run our new business model. As we look forward, those dollars that were allocated are changing. We have all the major investments from our -- that we used to build our foundation behind us. Now we're moving towards investing in marketing, investing in growth drivers basically, marketing, sales, these are clinic opportunities, OUS expansion. So we are shifting our investments, and we're also, at the same time, shrinking the base to get that operating leverage. So if you think about it from a leverage standpoint, fixed costs will remain relatively flat. And where we do spend our dollars will be in more of the variable type of spending that is aligned with our sales growth. So we're excited about the shifts that we're making and where we're going from an investment standpoint. From a cash flow perspective. So today, we expect to -- as we have delivered on our guidance, we expect to be -- have $10.5 million worth of cash in bank at the end of the year, which implies lower than a $6.9 million negative cash generation. As we look through the next few periods, we expect to improve that significantly next year with a much lower negative cash-generation burn. And then finally, the most important thing on the slide is the cash breakeven in Q4 of 2024. So we firmly are confident that we expect to hit that right before the end of the year in fourth quarter. And how we're going to get there and how we're going to transition into these positive cash flows, it's going to be about revenue growth back into the double digits that you just saw with our CAGRs. It's going to be that continued gross margin expansion, and it's going to be about spending in the right areas that support and drive growth. We will be targeting an EBITDA margin of 10%. And when you take into an account an adjusted EBITDA, we subtract out things like stock-based compensation, you could expect a much larger EBITDA margin on an adjusted basis, [to ] not adding back about $3 or so million to those vendors. So we feel very good about our cash position, where we're going and the trajectory of our cash over the next 3-year period. So I'll wrap it up here with our 2026 financial profile. What I have done here is listed our 2022 guidance in comparison to where we're going to be by the end of 2026. You can see revenue more than doubling to $60 million, and that's going to be based on executing our strategies that we just discussed, winning some NT, some additional NT opportunities. And of course, a market that's stable and growing. Gross margin expansion, as mentioned, we continue to progress in our gross margin activities within our manufacturing footprint and within pricing and seeing nice stick. Operating leverage, we expect operating leverage to improve, as mentioned, by reducing our operating expenses as we grow our revenues and really benefiting from some nice operating leverage over the course of the 3-year period. EBITDA will turn positive by about $7 million. And again, digging out some adjustments, you can expect a higher EBITDA on unadjusted basis. And then finally, our cash balance. As I mentioned, we will see a little bit of a dip over the next period, but then we're going to shoot out of that. Out of that will be plus -- will be greater than $15 million on a cash basis. So again, we feel very good, strong about these financial projections, and we're excited with what we've heard from the team here and our vision for '26 going forward. Thank you. I'll turn it back over to Linda to wrap this up.

Right. Thank you, Tom. Okay. So a couple of slides, and then we're going to have all of you ask us questions on what you've heard today. So let's come back before we ended on our Vision '26 commitments. So we talk about a 20% revenue CAGR. You'll see that increasing over time. Obviously, next year, what we've set out initially and talked about on our last call, you'll see next year somewhere in that 12% to 15% range. And then as we get our new products out, we get some more Novel Therapies collaborations and expand geographically. You'll see that increasing to that 25% range. 5 Phase III trials, which we had. Again, we have 2 in progress today. We have 1 launch drug. So with that, we're confident to reiterate that we'll have 5 Phase III trials. Why are those so important? Because they're one step closer to a launch. Commercialized NT drug indications. We're looking to increase that to 3 commercialized new drug opportunities by '26. Where do we get that from? We today, as I talked about, have 2 Phase III trials. That's with kind of one of those succeeding. I talked about the partnership that we hope to announce within the next month or so that is already a launch drug. So that would be 2. And then we're counting on getting one of those infusion clinic opportunities into our pipeline. So we think a fairly reasonable 3 commercializing drug indications. 8 new products. We've got 4 of those behind us already that we've done to date, not quite 2 years in. With the pipeline of everything that Brian talked about, we expect to have 8 new products/drug indications by the end of the period. And we've already achieved the $2.5 billion TAM. Remember, some drugs will fail. So we've got work to do to maintain that because we're not expecting that every drug that's in our funnel now will make it out the other side. And essentially reiterating our revenue commitment. So overall, just sitting back and watching the story today, 5 key messages, which very excited. A lot of hard work over the last 2 years. I've been here now just about 2.5 years. Site didn't exist. The leadership of the organization didn't fit. We had no Novel Therapies pipeline. We had no innovation. I remember sitting down and saying, hey, show me innovation. We had 2 engineers, and we had about $400,000 sitting in the bank. So thank you, again, for all of your [ support ] because it allows us to do this. First of all, you see significant macro tailwinds in the movement of health care to the home. Those slides on the number of new drugs that are coming to market are third-party data or not data from KORU on file. So you see a large and sustainable and growing market and the pace of those introductions are repeated. We're fortunate that we don't have to depend on just launching a new drug or somebody else's success. We have a very profitable Core business today, both here in the U.S. that we're looking to expand internationally. That gives us then the reputation and the credence to put several new drug entities onto our pump platform with Novel Therapies. We feel confident in our ability to do that because of what we're going to show you in a very few moments, a very differentiated product portfolio. And then finally, given that recurring Core business and all of those investments that are behind us in R&D, we've got a lot of that work recurring behind us in this building, we see a very viable pathway to profitability. So thank you. Appreciate all the support to date. Now the fun starts. Here's what I'm going to suggest. We'll Q&A. Maybe we can pause for a moment. How is everybody feeling on a bio break? How many need bio? Anybody? We're good. All right. Let's go. So maybe I'll ask the team. We'll pull our chairs over and we'll start with Q&A and then we'll head over and Brian and his team are going to take you through the numbers [indiscernible].

Okay. So I'll start by fielding the question and maybe, Caitlin, did I see you go first? I'll know if a show of hands. How about that?

Well, thank you for presenting today. And just maybe to start on competition. You mentioned new entrants into the market, Enable Injections. I know you're only competing with them on Empaveli at this moment, but maybe you can just address the potential threat competitively that they provide also from a form factor dosage standpoint and how you're addressing that?

Sure. So great question. So first, I would say that overall, as we see new entrants come to market, we're actually excited by that because I think new entrants will put more credence to the opportunity for subcutaneous delivery in the home. We haven't put that expanded factor into any of our numbers. But overall, we see our platform versus Enable, I would say, first and foremost, is speed of delivery time. Because of the technology going through 1 ported needle, we feel that our speed of delivery time should be more than it was. Second, and this has already proven out, SOBI, which is the commercialized partner for Empaveli, Aspaveli in Europe, has chosen to not launch with the Enable platform because it's not a sustainable platform from their perspective. You throw that device away every single time as well possibly as the transfer device. Third would be our cost. So as I talked about, fully reimbursed platform. The pharmaceutical company, we believe that we're sometimes somewhere between 2x and 5x more cost effective than that platform. And we believe that -- and I'll use this statistic. So 15 years ago, I ran a diabetes business on a global basis. And a pump, an on-body pump was launched and my board said, they're going to take all our business away tomorrow. Well, 15 years later, what percentage of patients are still on an on-body platform in diabetes? 60%. So we believe that it's a patient choice and we love patient choice. We think that's important for patients. We believe that it is a nice little product. But we believe that for all the reasons I just described that we'll have a great platform. They also -- just maybe one other thought I would say to you is that they have a platform today that is for 20 mL. We believe the limits of our system are around 25 mL. If you go above that, you're going to need to wear several devices on their body. And we know that 70% of patients in Ig today are about safety. So we feel really good about our Core Ig business. Thank you. Great question. Go ahead, Alex.

All right. Excellent. Thanks for the presentation. Maybe just to start on the subcutaneous Ig market. Obviously, we've seen the weaknesses throughout the year. Have you seen things improve in the last several months? Maybe speak to what else you incurred in the market around why the weakness even occurred in the first place? And I get what you're seeing recently.

Yes. So clearly, I'm going to hand this over to Ken to field this question on our SCIg market. But clearly, what we showed today, if the smile wasn't big enough, right, halfway through the year, we've seen steady progressions each quarter and seeing that number at 7.7% in quarter 3 was very exciting for us. It's what we've been talking about. It's what the pharma companies have been talking about. I'll let Ken go to what are the underlying drivers of that and why do we see that continue.

Yes. I think looking forward, why we're so confident that [ likely ] we'll continue to grow and grow healthily, I think one that we have 4 drugs now approved for subcutaneous infusion. And since the pandemic, we have 2 new drugs. So I believe overall Ig supply is much stronger. I believe the pharma partners have bounced back in terms of plasma donations since the pandemic. And all of that is enabling greater transition from IV into subcutaneous. I believe what slowed down the early part of the year is just less infections and less diagnosis. So while we're in 2020 and 2021, we were in a sheltering place situation. Therefore, folks were not getting out of the home, getting those infections like Christina, and therefore, not getting diagnosed. And as Linda indicated, with Christina, it takes 10 to 15 infections before you actually get diagnosed. And so, therefore, we think we're starting to see that increase in infection rate, the flu rates in '22 to '23 as well as another strong flu season this year will lead to continued higher infections, which will lead to higher diagnosis, which will lead to continued growth. And last but not least, I believe that the prefilled syringe opportunity will accelerate that movement from IV into subcu. As Linda indicated on our first slide, the subcu market is only penetrated by about 20% today. So there's significant untapped potential for those patients to move over to subcutaneous therapy. Both Cristina and the KOL that spoke with us today spoke about those benefits. So that's why we're optimistic for continued accelerating growth in the market.

And if I could just ask a follow-up to that on the prefill piece. Did CSL endorse your 48%, 50% penetration in the next several years? And on the prefill side, you talked about a backlog of orders happening even before we've seen the launch. Maybe expand on that.

Yes. As it relates to our partnership and collaboration, I think we all agree that because of the fact that 70% of the patients require a dose of greater than 50 mLs or more, both CSL and ourselves are optimistic that the penetration and adoption of PFS will significantly accelerate next year. Once PFS first came to the marketplace and we got approved for our 20 mL prefilled syringe, the market tripled. Right now today, it's about 13% penetrated. We would anticipate that it will triple again. And your second part of your question, Alex, was?

So why are we optimistic around the backlog of orders.

Oh, the backlog, the backlog of prefilled.

Yes, the backlog, we're really excited. I believe Rob and team have already started to take some fleet orders. I believe both our distributors and our SPs are excited about the opportunity to adopt prefill syringes into their clinics as well as provide them to their patients. So once January hits, we're going to be ready and available for when CSL commercializes their prefilled syringe.

And we've been very -- what I would say -- or, again, what's the end game driving the consumable sales. So we're looking at things that we're doing in the marketplace that ensure that everyone who wants access can bring those [indiscernible]. I do want to couch that we're changing therapy here, that today, obviously, the majority of the market is on vials. So this will require a lot of work by Brent and his team to be training in the field on that clinical practice change. But clearly, both with 20 mL and now what we see with 50, we're excited about that. Jason?

Yes. Helpful presentation. everyone. I really appreciate it. I do want to build on Alex's question there on the market. I think, Ken, you suggested that you're looking at something 6% or 6% to 7% for 4Q and for SCIg market. And then that continuing, but you're conservative with that 6%, but then also looking at 6%, 8%, 10%, which actually is an acceleration. So actually, it sounds like you're getting more aggressive with the out-year outlook. So maybe help us with the underlying assumptions. Like what builds to the confidence here as we sit today? Is it what you're seeing real time? And then also what contributes to the assumptions you're making on modeling out 6%, 8%, 10% for market growth?

Yes. So overall, I think 6%, we feel it's where we're right now, okay? So that number, as we go into next year, we want to make sure that our base is sat at an appropriate level. When we see proof that, that is accelerating, we did in quarter 3, but it's only one quarter, so we want to see before we maintain a couple of quarters of that before we start to [indiscernible]. Everything I would just say that Ken repeated earlier in terms of prefills, we believe that overall, new patient diagnosis is increasing because of the increased infection. I hate to say it, I woke up this morning with a tough throat. Part of me said, "Gee, bad day" and part of me said, "Yes, there's a lot of infections going on. It's going to drive increased diagnosis." But 2 years in a row of strong flu seasons, I think is going to be great. And then you just look at the investor presentations and the earnings of our big pharmaceutical companies in subcu development, they're all talking about subcu as being the way into the future, so that's exciting. And one thing we haven't touched on at all, I believe in tipping points, right? You get to a point in a market where there's a certain percentage of KOLs that are on subcutaneous therapy. We know that PID, which is primary immunodeficiency, which Christina has, the majority of our patient base, 85%, we know today, 40% to 50% of those patients are on subcutaneous therapy. We believe once that number gets to that 50% to 60%, you'll start to see a tipping point and CIDP, which Ken mentioned, prefills are prime for those users. They only represent today under 10% of our total user base. So seeing a tremendous potential there.

Just one follow-up and maybe a little bit related here, but you are a little bit short of where you thought you'd be for 2023. But you're keeping that $60 million in place, which is then resulting, just the way the math works, in a higher CAGR over -- when we look '24 to '26. So what's filling the void, I guess that -- is it the in-clinic revenue? Or is there something else that you're adjusting the assumptions on versus where you would have been a couple of years ago?

Yes. Two major adjustment changes. The first one, you picked up which is in the in-clinic opportunity. We feel is a new opportunity we didn't understand. We've done a lot of research and work in that area. We've tested in clinics already that saw the value prop. So a lot of work ahead of us. Some might have said, well, hold up, you're saying $40 million, you're putting 3 to 5. We've still got work to do to get those drugs approved, but that is a big new opportunity for us that I'm hoping presents an opportunity to outperform. The other area we've gotten far more aggressive is in our International expansion. So if you look at what we had in the prior plan was getting better in the markets we play in today. So getting better in Germany, getting better in France, getting better in Poland, et cetera, getting better in Spain. It didn't have those major expansions. And those markets, we talked about are 3 of the top 10 markets around the globe. So with prefills and our leg-up, that is providing us a tremendous piece. CSL, in particular, will plan on extending that brand around the globe. And because we're the only one with a prefilled system, that is expanding our potential globally. So those would be the 2 big ones that provide that upside opportunity. Michael, No? I'm sorry. Bill? Bill? Can I call you Bill or William or?

William.

William, sorry.

No problem. It's fine. William Wood, B. Riley Securities. So two if I may from us. The first, you're obviously expanding into the clinic. And I was curious sort of what you're seeing with the prefilled syringe uptake in the clinic, how you see that driving that? And if I -- maybe an alternative way to prove -- suggest that or state that, in the clinic, you have an experienced staff and available syringes and equipment, obviously, other medical devices. And could this actually provide a barrier of entry where they prefer fillable syringes, maybe using the mechanical pump, obviously? And then additionally, does management become less important with your new pump becoming available with sort of a one size fits all?

Yes. So most of the administrations we see -- and maybe adds on to Jason's question. Most of the opportunities that we see in that clinic are somewhere between 7 and 15 mLs of therapy. So overall, I think when our new pump launches, we think that will be because if you want 7, we can engineer it to 7. The good news is the innate technology that sits inside of that pump is a platform we've had in the market and have patented technologies on. What we've changed is the exterior to make it easier for a nurse or a patient to use. But if we talk about that in-clinic opportunity. So today, the nurse is going to get the drug drawn from the pharmacy. She'll already have that prepared and ready to go, whether it's in a prefill or not. What the real advantage is, is getting them away from that manual push, that challenge that is trying to get that into the patient every single time. And, so what we've got to do is show that nurses are more satisfied. Satisfied nurses mean they want to stay with that clinic more with nursing shortages, and we have to show that, that patient gets equal or better outcomes with our drug delivery technologies.

Very helpful. Just actually to follow up. You've obviously have 2 pumps and one for Novel, one for KORU. They both seem to deliver on multiple dose sizes as well as prefilled or filled, I guess. And I'm assuming both are mechanical base. What's -- I guess a little bit more understanding of why the need for 2 if they sort of seem to do the both the same?

Sure. Great question. Trust me, our Board questions a bit on that one every single time. So today, we have a SCIg market and the differentiation in that market is that it's a weight based. So those patients, I go to a pharmacy and those patients are anywhere from 5 mLs of therapy up to 150 mLs of therapy. So now my pharmacist's at the counter. And I'm sitting there and saying, "Okay, do I dose it with FreedomEdge? Do I dose it with a FREEDOM60?" Wait a minute. They have -- they require 65. That's going to require a 50 and then it's going to require a 15. So I can use a prefill for part, but then I have to draw. So why did we need to do something for SCIg independently? It's a weight-based format. We've taken all of the mystery out. The patient goes to the counter. It doesn't matter if you're 5 mL or 150. We're going to give them our new pump, and it's going to work across vials or prefills. The engineering Brian and his team has taken all the mystery and put it into that pump for SCIg. We don't need that complexity for Novel Therapies. Most of our Novel Therapies patients, so there's a size and a weight trade-off when you go to that. Brian's going to show you our initial prototype for our new SCIg pump. But for Novel Therapies, they're a set dose. So they're 7 mL administration once a week or a 10 mL administration once a week or a 15-mL. So with that set, those allowed us to make it much smaller and easier to use for Novel Therapies. We also added on opportunities for electronic tracking. And the other thing that we did, very unique, is we made a proprietary consumable system with that. Why is that important? It means we get a 100% match of that consumable with our policy. But the good news is the same technology that's inside is used across both platforms. So we didn't have that mechanical technology that we use. Why is that important? It's cost-effective. It's simpler for the patient. There's no valves. There's no alarms, et cetera, are going off, so.

And proven.

And proven. Thank you. Frank?

Yes. So when you were talking about Vision 2026 and that bridge to $60 million, you called out $13 million to $17 million of U.S. Core. My assumption is the majority of that is a lot of the 50-milliliter opportunity. But can you maybe break out some of the different pieces of that U.S. Core? Particularly maybe CIDP, if there's any like price opportunity or price expectation with the new pump? I'm assuming it's priced dose, so 7 to 20-milliliter growth, but try to kind of bridge us in that $13 million to $17 million given that's the biggest chunk of that growth to $60 million.

Okay. So how about we do this? We'll talk about what drives the majority. As you know, we went a step closer today at giving you some numbers in terms of Core and International and Novel Therapies, but we're not going to guide by each area of what we do. But I would say, overall, prefills will be the #1 driver of that growth. Again, it's through share positioning. And then as we get to our next-generation pump and our next-generation consumable, you can expect to see some ASP improvement, but also more stickiness between that pump and the consumable set with our patient base. So a one-to-one match of the consumable only being available to use with that pump. So that would be #2. And then the third piece is obviously just increased penetration relative to the current accounts that we're in today, with both the innovation platform. So it's a mix of all 3. We'll do a better job as we get to our in year to describe the specific that will line. And, Ken, did you want to add or Tom?

And on top of that, we mentioned the market growth, Frank, the 6%, 8%, 10%. And then also, if you remember with this pipeline slide, on the top section of that pipeline slide, there's a lot of launches for new indications on the SCIg front. So that will also add market share gains on that front as well.

Okay. And then maybe just one follow-up on the pump and new infusion set. Though there's some price opportunity, it sounds like as well as maybe some manufacturing efficiencies. Can you maybe just talk about gross margin expectations from those 2 and how those could help the margin profile?

Yes, sure. So our new consumable set will have -- we'll come out with new features. We expect there'll be some premiums in the market. I can't get specific for competitive reasons on what those prices increases will be. But certainly, when you walk around and you see the new consumables, that's generally just the first advanced feature. So we expect to see some premiums in the marketplace driven by those. And then with respect to the pump, our new pump will be universal pump. It will allow to -- it allow for specialty pharmacies to not have to stock up on 2 different pumps because it will be a one-size-fits-all pump and that'll also bring opportunities in the marketplace to also receive higher ASPs on our product line. And then from a manufacturing perspective, of course, scale is always something that we're looking at. And so as we continue to grow our business, we do have tiered scale relationships with our outsource manufacturers. So we expect to receive some volume tier scale pricing as well as improvements locally in our manufacturing here in Mahwah on our pumps through our continuous improvement and operational efficiency gains.

Yes. Maybe just 2 additional thoughts on that. So first is we will be looking at rationalizing our SKU base on our consumables pretty dramatically when we launch our new consumables platform. We understand much better now than we did when we went into this space close to a decade ago because of the work that Brent's been doing on what actual clinical practice is. So we see a major opportunity to reduce our SKU base, which will also drive increased manufacturing efficiencies. Chris reminds us of that every day. And then the second piece is that we will have the opportunity to have 100% stickiness between our platform. So today, we believe we lose about 20% to our competitors. And the sum of the improvements in the needle and the clinical plans we think we'll have, we're expecting to gain some from that, increasing that overall stick rate per pump.

I want to push back on the International side. Sorry, Ken. International, I think we've been talking about this for a while on CSL and all the others are in the international market selling. Has [ that trend ] the other drugs there for some time. So really, what is the -- what drives the expansion for KORU in those markets? Is it really the prefilled launches and your on-label prefills so that's what really drives it? Is it doing some more investment, whether it be people actually in those countries, and that helps there? Like what really gets the growth going in International?

Yes. I really believe that it's all of those things that you just mentioned. One is continuing to leverage our partnerships with our pharma partners in key geographies. Two, I do believe that our innovation and new products that we'll be bringing to the marketplace will allow us to differentiate ourselves and show the superiority of the Freedom platform over ePumps. So let me just step back, Alex, and say that the market is there. Unfortunately, we don't have that market, but our competition does. But we believe that we have a superior platform today as well as what's in the pipeline. We believe that we've got very strong partnerships and relationships with our pharma partners which the ePump manufacturer does not have, as well as we believe that our innovation is going to drive that deeper penetration. So not just to win in Western Europe where we play today, and I think that we've shown best practices in terms of the sheer category gains that we have in the Nordic region like in Copenhagen, or in Sweden -- I mean, or in Finland. But I believe there are other opportunities, whether it be in Canada, whether it be in Australia or in Japan, that representative fresh opportunities for us to continue.

Okay. Got it. And then the approvals for the new pumps, obviously, there's 2 different pumps. So the Ig pump, what are some of the time lines there for approval? And then on the Novel Therapies department, same question, added on, are any of your drug companies partners using that pump today in their clinical trials?

So the approval on the SCIg pump, we expect to have it either -- well, I'm going to say, when me expect to file for a 510(k) because the FDA is out of our hands, well, we expect to file that by the end of next year or early into '25. So you can anticipate that our average time has been 120 days. I would say, the good news is we've got a predicate on file, right? This isn't -- again, why do I keep coming back to that mechanical system that's being used inside? We're doing some very difficult things from an engineering perspective in trying to accommodate any syringe size with what we've done with this system. But we believe end of '24, early '25. And then on the Novel Therapies pumps, we today are -- this year, what we'll do is we'll put -- what we did was work on the form factor. Now we've got to put the internal system into that form factor, which will complete this year. We have a -- and what we've done because of our 510(k) pathway, it's easy for us to take a transition from you were using our Edge or our 60 and you're now converted into this new system. So we have -- we won our goals this year. Our goal that we'd set for ourselves is now multiple new pharmaceutical companies that are interested in that new Novel Therapies pump and committed in a signed contract. Brian hopes to deliver the first one over the course of the next quarter on that one.

By the end of this year?

So we would have multiple new that we hope to have by the end of this year that have committed to a partnership with us on that Novel Therapies pump. We hope to announce our first one within the next quarter. William?

Just a quick follow-up. On your -- you had mentioned that you have multiple launches coming this year that could potentially -- that are currently in sort of a Phase II, Phase III. I guess they'd be in Phase III. Typically, indications are vastly different in size [ we could pretend ] for vastly different opportunities. When we're thinking about these Phase III trials that are nearing completion and they get to commercial with launch, should we be thinking about these all roughly the same size? Or are these actually quite different in size as they may or may not hit the margin?

Yes. So first, I just want to say that we didn't say multiple new launches this year. We said by the end of '26. So I want to make sure that we're all saying the same thing here, that near term, we'll focus more on our new products and things like 50 mL, things like our new consumables, et cetera. But I think what you mean by size is the size of the opportunity, the number of patients. Yes. In the data that I show on the overall Novel Therapies pipeline -- can you just grab the -- from the -- I'll just go back for a minute. What you see is that they have many different patient sizes. No. Sorry, I just want to go back to a slide. I apologize, Brian.

No worries.

So all right. There we go. So these are all, as you see, different patient population types. They're all in different phases between Phase II and Phase III. We'll get better at, and you've heard me do this today. I talked about -- for example, I talked about the endocrinology. We expect that to enter Phase III. So you'll see me start to update on our regular earnings calls. This one has now entered a Phase III trial. So hopefully, we can report that in quarter 1 of '24. For example, I showed you today that hematology asset, where I said they're going to report out their Phase II results. So that's how we'll stay with you in terms of reporting our progress. And then, obviously, these patient bases, we take -- everyone is a unique case, where we take the patient population; how many infusions do we expect per year; what do we expect the competitive environment for that drug to look like; what do you expect our win rate to look like? So it takes you from this $2.5 billion TAM into about that $200 million range that I talked about at peak, if all of these launch. We're talking about $80 million as the [indiscernible] number. So the more shots we have in goal here the better. And the one thing we can't control is whether or not these drugs make it to success. But we know that the ones in Phase III (sic), 30% chance, we know the ones in Phase III, 70% chance. So we report positive Phase IIs, woohoo, that's great news for us. Because once they get to Phase III, we get a much bigger opportunity. So that's why my last slide also focused those in-clinics that are already approved, that's a great opportunity for us because the risk -- the biggest risk we have as a business is the risk of the drug succeeding or not. And then, Frank, just to your earlier question, what I was referring to is why do we also see increasing growth in immunology and neurology, all these ones above represent new indications, represent new drugs they're bringing to market or represent new geographies they're getting into. So that's why you see that accelerated growth in our subcutaneous business.

And one for Tom. Appreciate the gross margin trajectory that you're laying out here. I'll ask a silly question maybe. Why wouldn't it be better? If you're getting 25% CAGR over the next 3 years, you should have some pretty good leverage, fixed cost leverage. So is there just more variable cost here in the structure than I realized or are you being conservative? Like could it be where we'll normally be? I'm just curious.

Sure. Over the next couple of years, we're launching a lot of products, right? So within those launches, you do have start-up costs and manufacturing. Linda also mentioned that we are looking to phase out our legacy products as well. So you have some inefficiencies that are built into the plan simply because you're starting up and it's not easy to start up, so you have inefficiencies there. I believe that we do -- we have upside in the back end of the year, but we have to just see how the market treats us and how certain other factors go with respect to our launch plans and really some of our pricing planning in the outer years.

Maybe just 2 other things to add. More geographic expansion. I'm sure all of you know this from other companies you [ acquire ], what's the highest priced device market in the world? The U.S. by a large factor. We're expecting some price pressure as we expand geographically. And then what's not in our plan today, and we'll look at this based upon our success in the market, but automation, which Chris has already put together a plan where it could significantly accelerate. That's going to require capital investment. So we've got to see how this goes, and then that could be a plan. I'd love nothing more than for us to say we're on our plan seating, and we've launched a couple of these new drugs be able to go say, okay, now we're at 25%, 30% where we're positive cash flow, positive EBITDA. Do we need to invest more then back into those business to go after some of those expanded margin opportunities?

Great question.

Okay. So thank you. Hopefully, you're as excited as we are about everything we rolled out. Now we've got 2 options for you. I think our Head of Operations will come and we'll do a building tour, if you like. But first, we want to walk over and show you some of the products that we've talked about earlier. Thank you again.