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Okay, so good morning everyone. I'm Tom Adams, CFO of Koro Medical. Happy to be here today. I am going to show a couple slides just to give an overview of our company, what Koro does, Koro at a glance, strategic initiatives, and then talk a little bit about our long-range plan. So I'll start off here with a short slide deck so slide one so what does Koro do we enable simplify enhance the delivery of large volume subcutaneous drugs into the home in the clinic so we are a player that since COVID and the shift over from intravenous hospital settings to subcutaneus therapy we are the home delivery device so we We play in the home infusion space and also with the infusion clinics. Our platform, which is our Freedom Infusion System today, it's primarily used by about 60,000 patients. These are chronic recurring patients that require subcutaneous immunoglobulin drug therapy treatments. We are expanding our market beyond the CIG. So not only are we on this, but we have current collaborations. We have, today, eight collaborations where we work closely with our pharmaceutical companies to really bring new drugs onto our platform. So that requires working with them, getting their drugs, testing their product, and then submission via 510 to FDA or MDR through the EU. We are leveraging a low-cost go-to-market by basically serving pharmaceutical companies. We specify pharmaceutical companies in the home care networks as well as distributors. If you look at our company at a glance, we have about 60,000 patients globally, which covers nine drugs that are on our label through 30 countries. Our guidance right now is about 47.5 to 48.5. So we've been running at about a 19% CAGR, which I'll go through in a few slides. year our growth is around 15 to 18% cash balance on the balance sheet 8.3 million we're located in Mahwah New Jersey and really what our model is as I mentioned we work upstream with pharmaceutical companies we obtain their drugs we test them and we submit to FDA for use on our delivery system if you look at what our products actually are. This is a picture of the Freedom system. We have the Freedom 60 and the Freedom Edge, which are two pumps, and we actually have another one under development as our next generation pump. These pumps work together with the infusion sets that you see listed below, such as a needle set and a tubing set, which basically attaches to the patient and delivers the drug. And again, these drugs are delivered into home space by chronic patients roughly about once per week. If you look at the movement of healthcare from hospital to the home, we are driving a large subcontinuous infusion opportunity. So if you think about the SCIG opportunity, which is largely our base of our business today but we are moving towards this non-ig opportunity which are all the other drugs there's about 95 drugs out there in development by pharmaceutical companies which we're you know which we are actively uh targeting and working with to get these new drugs on our label so that's our strategy from an overall company and then as you look at our strategic growth pillars. We have a core business which is around 80% of our business and we continue to pick up market share. We're around 60 to 65% market share in the U.S. We are expanding international so we have a lower share in international with a lot of room to grow for market expansion and then finally as I mentioned enabling more drugs onto our platform gives us more outreach for for more patients out there looking at our financial highlights you can see over the last couple years we've grown nicely with about a 19% CAGR and this is largely driven by again defending our share in the US but also expanding internationally so we've had a we've done a nice job with respect to revenue if you look at our first half of the year you know we're up about 20% growth year-over-year. Gross margin has been picking up at around 63%. Our OpEx, we have a nice leverage platform. We don't need a lot of feet on the street to sell our products. We work basically through specialty, specialty pharmacies and distribution. So we have nice leverage scale as we grow our top line. We don t need to add as much on the on the bottom lines. Our net losses have been pared down over the last few years. We just had a first quarter of the net income positivity just in Q2, and our adjusted EBITDA is positive at about 900,000 first half of the year. From a cash perspective, we burned some cash in the last few years, but we're now at the point where we are no longer burning significant cash. We had reinvested back into the business, back into our footprint, and now we're starting to see some returns on our investment coming through this year and also in future years to come. As we look at our execution and our key strategic progress, again, as I mentioned, Q2 revenue was about $12 million and it represented about 18% growth. Our net income was about a 222% improvement over the prior year. So again, we had net income in the black for the first time since 2019. So we've made that inflection point on net income. We acquired a connected and monitoring digital asset to potentially strengthen patient support. So what this means is it's a technology that allows us to better control the adherence and use of our pump, which we believe that data monitoring will be important for our future across our product platform going forward our q2 gross margins hit 65% so we expect we we actually lifted our gross margins for the rest of the year we've done some nice work with the contract manufacturing supplier obtaining a five-year multi multi-year contract with a significant margin expansion on cost of goods we withdrew our 510 application we had a 510 application for Fezgo, which was an oncology product. It wasn't a significant product in our portfolio, but we withdrew it due to a label requirement on the IFU. We entered in, again, we entered into an updated supplier agreement supporting our long-term operational strategy and gross margin expansion. So, as I mentioned earlier, with volumes moving upward the last couple years we've been able to obtain and secure a longer-term favorable supply agreement with that with our contract manufacturer and then finally we narrowed our year-over-year revenue guidance to forty seven and a half to forty eight point five million to account for our PFS conversion PFS is a pre-filled syringe conversion we are we're doing well with it and we're very excited about the opportunity. We are just a little slower in Europe simply because of the market dynamics and the time to convert patients in some countries over in Europe. Then finally last slide here is just really looking at the future and our strategic growth plans. Fundamentally we have a large growing market for SC drug devices, and we maintain the leading market share in the U.S. Again, we have a recurring revenue from about 60,000 patients, and most of these patients are chronic on our system, and continue to grow that position of patients. We have new strategic catalysts in SID, which we feel is going to be a nice tailwind for us. in the future as SID gets reimbursement out there in late in 2027. And we have eight non-IG pipeline drugs with Restiguia as one of them and a few others that are near term, you know, single base hit opportunities, but they allow us to establish a footprint in the clinical setting as well as what we already have, which is the home setting. When we stand back and look at the long-term financial goals, we expect to be a $100 million revenue company. So we've doubled in the last few years in terms of revenue, the last three or four years. We expect to achieve about $100 billion. We expect double-digit revenue CAGR to continue and accelerate our gross margins. So as I mentioned, we just signed a new supplier agreement, and we're doing a lot of things with continuous improvement to, you know, really maintain that plus 65% gross margin profile. And then, of course, you know, at least 20% EBITDA margins. So with $100 million in revenue, we should be able to maintain these long-term financial goals. And that is it, Caitlin. Great. Thanks, Tom. Maybe just touching on a few of the points that you highlighted, oncology continues to be a major focus for you guys, particularly with Fesgo, although you noted the withdrawal of the 510K for use of Fesco with Freedom Edge in the Maybe just a little more color on the withdrawal and why it's still a viable option for pursuing OUS. Sure. So the withdrawal of Fezgo was really related to a specific issue on the label, particularly on the FezGo product. It really didn't have anything to do with the safety and efficacy of our pump platform. Fez Go was really a pilot for us. It was an early entry. It didn't really have a significant market share, but we had the drug at hand. We had the collaboration, so we were using that as an initial go-to-market. The other molecules, while we were waiting for the Fesco submission, we learned a lot about the oncology space. And in the meantime, we're working to secure a much larger opportunity. So we were very excited about the space and getting into that oncology field with our learnings from Fesco, so we feel pretty good about it going forward. And I think you noted on the call as well that Fesgo was a larger opportunity internationally. Can you maybe just quantify how large the Fes-go opportunity was, US versus OUS, and then just broadening out, as you talked about, there's other oncology drugs within this TAM. speak to how broad the actual overall TAM is and, you know, which of those you could pursue for your label? Sure, sure. So that's correct. So with Fezgo, it was specific to the U.S. So we do feel that there's still an opportunity to launch in the EU with this drug. And so we are continuing to pursue that. With the opportunity in itself, it's, you There's about 4 million infusions, so we're looking at a $60 million TAM overall, which is growing at a pretty good pace. So we expect it to grow over the next four years or so up to about 140 million TEM opportunities. So we continue to move forward in the oncology space. We think we're a very attractive alternative simply because today the space uses hand or manual push, where we believe that our mechanical pump serves an unmet need to patients. So we feel that we can take advantage of that space, and that's why we're working with other partners to actively pursue entries. So once again, a small hiccup with the U.S. physical submission, but we feel pretty confident going forward. And, you know, do you expect this change to delay the timing of the U.S. oncology entry? Well, I would say slightly. Like I've been mentioning, we've been working in sync with another potential partner. We're hoping to have some good news to share on the November earnings call, where we are in terms of that strategy. But But that, you know, because of the size versus the smaller size of the Fesco, if we can work quickly and get it filed per our timelines, we don't think there'll be such a substantial miss from what we lost in Fesgo. And just on that point, any extra work that needs to be done to get a new submission together for a different molecule, such as studies or anything else? Yeah, so great question, Caitlin. So the way it works typically is you secure a commitment, you receive the drug from our partners, we do testing, we test for potency, biocompatibility, and there's a number of tests, flow rates, and then once we achieve the results that are desired or required per the specs, we then submit. And typically from an FDA perspective, it's between 90 and 120 days of approval time. So once we secure, or if the opportunity comes alive, that's how the timeline will play out. And I think oncology was one of your infusion clinic opportunities, along with the recently on-label Restigo. Maybe talk to that launch and your go-to-market approach in the infusion clinics side of care. Yeah, so it's exciting. Again, we were primarily a home care company where our patients were taking the infusions at home. With the approval of the Restigio, now we are in the clinics, so nurses are using it. So we've been very active. Restigios is a nice drug. It's grown 65% in 2025, so it continues to do well. So we are there with supporting nurses. Our sales team is there. It's primarily in a similar channel from an end-to-end process. And so we're familiar with that channel, Caitlin, and so we continue to work it through. And it's a single, it's not a home-run type of drug, but we do see some nice incremental sales from Restigio. And you also called out on the earnings call Biogen's acquisition of Apellis, which is the maker of M-Pavelli, S-Pavilli, which you also have on label. Apellis was working on expanded indications for the drug. How are you viewing the potential for disruption from this acquisition on the R&D timeline there? Sure. Anytime a large pharmaceutical company buys another one, they typically put everything on hold until they can evaluate, and then they make decisions. We don't anticipate this having any major impact on our PST revenues, which is where those revenues are slotted as we support their clinical trials. So it's, you know, no impact to our PSt business. We're still guiding between $2.5 and $3 million in our Pst. And then turning to international, you noted it's been a big contributor to results over the past year or so as you penetrate the PFS opportunity in Europe. And you also pointed to a more measured growth trajectory versus the kind of more lumpier results that you've previously seen. Can you speak to the dynamics here and why your expectation for the pace of growth has changed? Sure, sure. So Europe is, as we all know in this room, Europe is many different countries. And it's not globally centralized from a company management perspective. perspective, and what I mean by that is a drug company management perspective. Reimbursements are different in each country. Some countries are tender markets where reimbursement really isn't involved, and the pharmaceutical company converts the market very swiftly, and in other countries are more reimbursement markets that take a little bit more time, and there's more complexities in terms of setting up a new market launch, such as the PFS and the mechanical pump to go with it. So we're taking them one by one. And so what we've learned is these more complex companies are taking a little bit more time for us. We're really excited about the opportunity. We just think this is a timing delay as we get our pieces in place and set up the foundation. So we see this revenue shift more towards 2027 as opposed to 2026. That was the reason for our call down, which was primarily isolated and international. U.S. business was humming right along with that quarter-over-quarter sequential growth. And you launched in Japan recently. Anything related to that in the guidance change and just how the launch is going there? Yeah, launch is slow going. Japan is a complex market. It's hospital-driven. It's a hospital- driven market, so it takes a little time to penetrate into that market, and you have to set up distribution and importation and a little bit more complexities, but it's moving along, and we continue to see growth there. And so we're still excited about the opportunity. It's just a little slower than we had anticipated. Maybe just turning to financials, speak to the opportunity for just the continued margin expansion in the short and the long term and what levers you can pull to improve. but I know you mentioned the supply agreement. Anything else there? Yeah, so there's a few things. I would start with the supply argument. Again, with the last couple of years, we grew last year 22%. The year before that, 18% growth. So with that comes a lot of volume. So we've been able to leverage that volume that we've given to our key suppliers and basically turn that into a new favorable agreement for us and for them as they're getting the benefit of the volume. So that's come along nicely. and we're seeing some nice couple hundred percentage points from that. And then obviously pricing. I mean, we still have some nice good stick in the U.S. market where we're a dominant player. We're a 60% to 65% market share, so we continue to see that annual stick. So I think those two things in combination are helping us with some nice margin improvements. And then as you move into a new chapter where you call them PFTs, call them novel therapies, are transitioning to becoming part of your core portfolio. Is there any change in the cadence or composition of your spending going forward? No, I mean, I think, you know, with our spending, every opportunity is different. You know, from an R&D perspective, you know, we will continue to innovate and we, especially with the new acquisition of the technology. We will continue to innovate that into our next generation product portfolio. We will continues to work with our pharma partners. Sometimes, some of the drugs are more complex than others and require more resources, but I don't expect major shifts from what we've been spending. We'll still keep a percentage of sales on our R&D efforts. And then just turning to the core business and the potential SID opportunity, maybe just talk about that. How is that different from SEIG and what's the go-to-market strategy there? Yeah, SID is coming around the corner. I think there's four clinical trials out there to get reimbursement and SID. It's a huge market opportunity. We believe it's a nice tailwind that reimbursement will be approved. I think the clinicals are completed sometime in late 27. So we feel there's a Nice upswing with respect to new patients coming onto our platform, especially once that reimbursements occurs. And so we're excited about it. We're going to be ready for it. It's the same drugs. So all the drugs that are being used today on our platform for PID and CIDP will be available now for SID. And there'll be a lot more patients. So again, it's hard to know exactly how many patients per se, because it's not chronic. It could be temporary. People go on it. People are on it for a longer time. But there's a massive amount of patients that'll enter into that population once reimbursement is established so we're really excited about that in the years to come any questions from the audience yeah great great question thank you so the freedom 360 is our next generation pump what that's going to do is it brings versatility it allows several different sizes of pre-filled syringes to be used today there's no alternative for that so there's different pumps for different sizes so it it provides a lot of flexibility it allows for less inventory to be held on shelves at specialty pharmacy so we're excited about it the the submission timing is still this year so we expecting a second-half submission and then a a typical 90 to 120-day FDA approval, so for the U.S. market. And then ultimately for MDR in the European market will be sometime later in 2027. Okay, great. And then, Tom, anything you want to leave the audience in the last minute that we have about the business and trajectory going forward? Yeah, I'm excited for the business, clearly. You know, we've been growing very well. You know, you can see double digits the last couple of years, as I mentioned, 22% and 18%. You know we have a lot of excitement. We had a little bit of a timing delay in the EU with the pre-filled syringe conversion, but the opportunity is great and it's there. I also am very excited about the oncology opportunity. We do think it's an unmet need in the space, and we feel confident that we will get into that space. And so I'll leave it, I'll leave it with that, so thank you. Thanks Tom. Thank you everyone.