Christopher Arapoff, CeQur - Insulin-Delivery Device | LSI USA '24

Christopher Arapoff  0:03  
Good morning. It's great to be here. I'm actually standing in place of our CEO, Brad paddock who had to go to London this week. But it's fun to play bread per day. But it's, it's really, it's really an opportunity, great opportunity for breast secure to again share what we're doing with our very simple, innovative product. Our mission is to simplify the lives of people with diabetes. Diabetes is a big condition that that all of you know. And we're doing it in a very elegant way where we're really changing the way people get insulin into them. And so we'll spend some time today talking not only about the problem that we are solving, we are an early stage, commercial company. So we have started our commercial journey, but also give you a sense as to where we are and where we think this company can go. But we've got a very significant leadership team, as I mentioned, led by Brad paddock as well as rich Mott, a range of expertise both in the medtech pharma and direct to consumer space. And this team has evolved over the last couple of years. And we're now we're at a place where the foundational building blocks in the organization are there. And it's about scaling the organization to the next level. So secure is a Swiss based company. But our headquarters are here in the US all activities today are US based are based out of Greenville, South Carolina, high speed manufacturing in Columbia, South Carolina with redundancy in Tijuana, Mexico. The company has a three day wearable bolus only insulin delivery supply, it is filled with rapid acting insulin, it is applied to the body and people can dose insulin whenever they need to by squeezing two buttons on the side. And each squeeze delivers two units of insulin and I'll get into who it's intended to serve in a minute. But the product was originally acquired by secure from Johnson and Johnson who had acquired it from collibra Medical back when j&j was in the diabetes business, when they exited, secure, acquired the asset, and has been building it to commercialization. Since that time, we did close $115 million series financing in 21. More recently, a $50 million convertible note, we've been using those funds to stand up the high speed manufacturing, build the commercial team, and I'll show you some of the progress on that. We did pilot launch the product in the US. Right during COVID, which was interesting. With five salespeople that team is now built. And we plan to expand that even further this year and 24 and beyond. We had revenue last year of about $6 million predicting 14 to 15 this year and 40 The year after that. So we're in a very fast ramp phase of our of our organization. So the the problem that we aim to solve for isn't overly complicated. Insulin has been around for over 100 years, it is far and away the best glucose lowering agent that exists, the problem is getting it into people that need it. So for people that have type one diabetes, their motivation to doses is fairly significant because they needed to live for the type two population. And there are a lot of type two patients who have transitioned through the care continuum to needing mealtime insulin, that patient population is more challenging. They generally are prescribed insulin pens or vials. And getting them to take the doses that they're supposed to when they eat is challenging. And the data is very clear that a large percentage of them don't two thirds to 75% of people with type two diabetes that need insulin never get to the ADA standard of 7%, a one C or lower, very high percent. And it's not because the insulin will work. It's just not getting it into them. And there's all kinds of data and statistics about why but they just don't many people just don't take it out of the home. And all these reasons why they don't take it raises a one C and leads to the overall complications of diabetes. The fact of the matter is that dosing insulin every day when you eat is incredibly challenging. Think about all of you, you've been here at this meeting, you had breakfast, you'll probably have snacks, you'll go to the bar and maybe have a drink every time you consume carbohydrates as opposed to dose. The reality is for people with type two, hypoglycemia isn't an issue. They just don't. And so the adherence is the challenge, they have to inject over 1000 times a year. An application of a very elegant simple wearable is really a solution to the problem. And so we have brought this product to market, the physician and patient enthusiasm around the product is been very, very good. It's just a very simple, elegant wearable that people have under their clothing. You apply it that can be dose through your clothing. I could be wearing one right now and dose 10 units of insulin and nobody would know So it's very comfortable to wear, it's waterproof to click, it click delivers two units every time. So if you need six units of insulin, you'd squeeze it three times. It's been studied. And I'll show you some of the data on the on the studies, people will use it, their adherence is higher, overall glucose control is better. There are a range of safety features that are built into it when it's empty, the buttons lock, and so and there is no, there's no batteries, no electronics, it's a simple manual insulin delivery supply. So when the product is brought to the FDA for clearance, the FDA recognizes that it's different than what existed today. It's not a pen. It's not a continuous subcutaneous insulin infusion pump. And so they gave it actually its own unique characterization or own its own category. It's a wearable on body insulin delivery supply. And so it's really been helpful to have this differentiation because we don't intend to compete with insulin pumps. Insulin pumps are wonderful tools. For people that want that sort of technology. They're welcome to them, many type ones do a lot of type twos do not only about 5%, five to 7% of all of the insulin taking type two patients want an insulin pump, there's just a lot of technology. And so it fits a very specific patient population. And the data has clearly shown that people liked the product. And I'll show you some of that result in a minute. It's been robustly studied one of the benefits of having the product been acquired by j&j a number of years ago, as they put a lot of effort into developing some of the early commercial work some of that being clinical trials. So there's a very good large randomized, controlled clinical trial that was completed. That showed you put people on the patch versus the pen, and you get very meaningful a one C reductions. And again, this isn't complicated, just getting insulin into them. And so in the RCT, there was a very meaningful 1.7%, a one C drop for patients that used the patch that was borne out in 24 weeks, which was the study endpoint. But also, the study carried out to 44 weeks for durability. And it showed that they continued to maintain that reduced agency 63% of the patients actually got to the ADA goal. You may recall, when I started that I mentioned two thirds to 75% of people to type two diabetes using insulin never get to goal. So again, this is just another it's a way for people to get to that Ada goal that they've never been able to get to before. Additionally, in this study, there was a subset of patients that were using blinded continuous glucose monitoring. And at baseline, their time and range, which has become a very, very good marker and how well people are doing again, the time the ideal range is in that gray bar is where you want people to be it was less than 50% of baseline. And we 24 and improved 50% over seven to 74.1%, which lines up with the with the current consensus that defines a clinical target for time and range. There's also been recently some real world evidence data that's been put that's been done. And that evidence that real world evidence mirrors the RCT data that people using the product have very meaningful reductions in a one C, they get that reduction, not just because of using just because of using the patches, not about using CGM. So on the right hand side of this graph, it's also patients that had CGM or didn't. And there's meaningful reductions, regardless of whether they use continuous glucose monitoring or not. I mentioned a little bit about patients. The preference there's there's been surveys completed that have asked patients, which do you prefer your previous therapy or your secure simplicity, overwhelmingly, and these numbers are very, very high for med tech products. Patients significantly prefer this wearable approach to an insulin pen. Not only do the patients actually have high preference for it, but clinicians do as well. And it's very important to consider most of these patients that really are our addressable market that type two MDI patients are treated by primary care physicians, these are not health care providers that prescribe insulin pumps for a variety of reasons. The patient base that can be served by this is really being treated by a group of physicians that a at high satisfaction found the product very simple to train and teach. So it's a very large market. I know most of you are probably very familiar with the size of the diabetes space.

Our commercial strategy is up and running. We've expanded to 40 plus salespeople that's predicted to double this year. The reimbursement plan is entirely 100% pharmacy benefit has been very, very good. The pharmacy benefit manager uptaken plans 70% of the plans have put this on a formulary and with average pays being very low less than $50. And we have other marketing activities around ATP awareness and digital outreach and social media that's bringing awareness to the product. So we have a high speed automated manufacturing line in Greenville, South Carolina capable on this predict particular line of producing up to $300 million worth of product per year with the ability to add components to it to make it an even larger capacity. And we have a unique opportunity we are working in playing in a space that has huge upside more people coming in and having diabetes and transitioning to needing insulin, a very small percentage of the people that were focused on wanting or using an insulin pump. We have the capex investment in the in the green in the South Carolina line that gives us the ability to get to 65% gross margin. And we're starting to see these commercial metrics really model for a very large scale. So I'm happy to speak with any of you afterwards. Take any questions and thank you for your time.