Video Transcription
Frans Cromme 00:03
Good afternoon, we're switching gears a little here. You've heard a couple of talks around surgical; I'm going to talk about diabetes and how inventive engineering can improve quality of life and thus clinical outcomes. Diabetes is probably a disease known to you, with over 500 million people now diagnosed with diabetes, type one and two combined, mostly in the Western world, which is a significant amount, and more than 30 million people of those are in continuous use of insulin. It's quite surprising that only 2 million, so less than 10% of those insulin-dependent patients, actually are on insulin pumps because insulin pumps have been shown to improve clinical outcomes, and yet the vast majority are still on pen applications multiple times a day. That 2 million users represent today a little over 4 billion in market value on purely insulin pumps. So that excludes the insulins or needles or anything else, just the pumps, and that is now starting to accelerate. Let me show you why. There are two trends that are really making a big change at the moment. One of them is the arrival of wearable technology, which is where we play as well with OmniPod, a wearable, disposable pump made by Insulet. This is a dramatic improvement. This is wearable technology that really takes away the burden and the stigma that these large conventional pumps have that you have to wear either in your pocket or on your belt. The other thing that further drives acceleration is what we call AID or automated insulin delivery. This is the technical capability of combining a continuous glucose monitor (CGM) sensor, like you see with the Dexcom sensor all the way on the right, with your pump, and then dosing software that reads out the sensor every couple of minutes and adapts the instructions to the pump, essentially an artificial pancreas that takes away about 90 to 95% of the decisions that somebody with insulin-dependent diabetes has to make on a daily basis, and on average, that's about 200 decisions a day. So if you're a type one diabetic and self-administering insulin about 200 times a day, you have to think, "Am I grabbing another cookie? Do I sit on the bike rather than walk to work?" Every time you need to calculate in your head, "What does that do to my blood glucose levels?" These automated systems essentially today only require you to input your carbs and your meals; the rest is fully automated. Over time, with improvements of these algorithms and good pumps, that will be fully automated as well, so a massive improvement in quality of life for these 30 million people. Today, the market has three very strong players: Medtronic used to dominate this space with 80% market share. They were the market leaders 20 years ago, and two new players, also US-based, have really come over the last couple of years: Tandem, now around 25% market share with a far better user experience of their conventional pump and a very good automated system, still a conventional large pump, and OmniPod, as mentioned before, made by Insulet, which is a fully disposable, wearable system. Especially OmniPod, a full patch pump, is the one that drives the market growth at the moment. So essentially, only two players and a few other players at the fringes make this a very open space for new players to come in, which is where we play.
So we've developed a system called Kaleido. As you can see, it's worn by the models, also a wearable pump you wear on your skin. It's available in 10 beautiful colors, and I'll explain to you why in a minute. You wear it on your skin next to your infusion set. It's available, as the other systems now, as an automated system; the clinical term is hybrid closed-loop systems, and our whole proposition in engineering is geared towards personalization and flexibility. Why? Because no one is the same, and if you have a Medtronic pump, you have to follow certain rigors and rhythms. OmniPod is a fully disposable pump which you can't move on your body if your infusion site isn't working for you. So we've taken into account some of these challenges from our competitors and designed something that is more personable. You can choose where you want to wear your pump. You want to wear it on your skin, right next to the infusion set? Do you take the longer tubing so you can wear the pump, for example, in your pocket or in your bra, depending on what works for you? You can choose the choice of cannula length, which is depending on your fat tissue. The colors sound like a minor detail, but this is a massive difference for patients. You get to choose two pumps with two different colors, and it literally allows people to personalize the therapy because you will wear this thing 24/7 for the rest of your life. So why does it have to be black and ugly? That's our design philosophy.
Last but not least, we also decided to strategically partner with Diabeloop. This is also a disruptive French company that has developed a real smart self-dosing algorithm that does that calculation to predict where your insulin is going to go, reaches out to the sensor, and gives instructions to our pump. The reason we work with them is that they have the same design philosophy. With them, you can also personalize your meal announcements. For example, there are no standards, so it's really a personalized approach to the end user. Technically, there are three areas where we're different. One is size and weight. It is really small. If you compare it to the Medtronic pump, all these pumps hold the same amount of insulin, about 2 ml, for three days of therapy, where the Medtronic pump is 125 grams filled. So that's a massive difference compared to the conventional, and that makes wearability and ease of use easier. The second key element is accuracy. Most smaller pumps actually give way on their accuracy because most of the pumps are science-based principles. We have a different pumping mechanism, which is also where our IP sits and our protection. Essentially, the pump sits at the top of the cartridge, and a tiny piston, which is motored by the pump, pushes into the cartridge and dispenses 0.5 microliters in these little pulses. You can see in the animation that actually determines the speed of dosing. The graph on the right shows you the accuracy, and you can see that compared to some of the other pumps, the box plot on the Kaleido pump system is extremely narrow. That is particularly important with these self-learning algorithms because you have a consistent dose-response curve. So it's very small, it's very accurate, and at the same time, it is very low cost of goods and environmentally friendly.
Our North Star still is OmniPod with nearly half a million users, but that's a fully disposable pump, so you throw away a pump with a printed circuit board and two batteries every three days. Our pumps last for four years, and the only thing you throw away are simple pieces of plastic that you weld together with ultrasound. That also means that the amount of capital required to scale this is a fraction of what competitors have used, which, of course, is important for our investors because we can get to cash flow positivity far quicker than some of the others. So we've now launched. We've worked over the last 10 years to really get this right, especially on manufacturing scaling. I'll talk about that in a minute. We're live with a full commercial launch since the end of last year. We have around 2000 users in the Netherlands, France, and Germany. Germany, being the second largest insulin market in the world after the US, is really key for us, and we see a very, very good uptake at the moment. So the plan is to go to two and a half to 3000 users this year, up to eight to nine next year, and then duplicate that with direct sales forces in the field. So we now already have a significant commercial team driving this while we scale manufacturing, and it drives a revenue stream this year of seven to eight million, and next year over 20 million. So truly in a growth phase.
This has been our largest challenge, which is manufacturing scaling. So real quick for the sake of time, but this is where most insulin pumps have tripped over and failed. We spent a lot of time and effort over the last couple of years to get our manufacturing lines well, and now, with over 200,000 user days, we see that the product is robust, it comes off the lines, and we're ready to scale further. As said by everyone, and it's always true, you don't do this yourself if you don't have a brilliant team. So we got a very nice blend of talent: disruptive innovators like Tim, who's the founder and the inventor of the technology, who is still with us, working on next-gen, but others who are far more experienced in scaling FDA submissions and commercialization. And on the bottom is our investor base, last but not least. Now, with these proven scaling points behind us, with 2000 users and mature manufacturing processes, we're ready to scale and expand. So we're now raising Series D, a 40 to 50 million round to further expand across countries in Europe, get our next-gen system ready, including a pediatric indication, and submit that to the FDA for a full 2027 launch in the largest market in the world. And then do that through automation of our production. With that, and two seconds on the clock, I'd like to thank you for your attention. Thank you.
