Ypsomed Holding AG (SWX:YPSN)
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H1 21/22

Nov 4, 2021

Thomas Kutt
Head of Investor Relations, Ypsomed

Call. Joining me today are Simon Michel, CEO, and Niklaus Ramseier, CFO. Our press release, report, and presentation discussing our financial performance are also available in the Media and Investor section of our website. With that, I will turn the call to Simon. Simon, please.

Simon Michel
CEO, Ypsomed

Thank you, Thomas. Good morning, good afternoon, ladies and gentlemen. Welcome to our half year’s 2021/2022 results conference call. Let me start by setting the stage and spending a minute on our strategy, and just taking a minute on telling you again on where we are and what our focus is. In both our segments, delivery systems and diabetes care, we have a very strong home care and self-care focus. Not only that, in both segments, we have increased our activities in digitization, in bringing more and more digital assets into the game. In both segments, we have extended our efforts on lean management, lean production in order to stay affordable for our clients worldwide.

In both segments, we have been able to close smart partnerships over the past half year in the space of delivery systems, for instance, with SCHOTT and Lonza in the space of diabetes care in the area of algorithms. When we look at our strategy, we have our four pillars, innovation, access, responsibility, and our platforms. It's important to know that the growth drivers and our purpose are intact. Chronic conditions, not only diabetes, but also Alzheimer, asthma, cardiovascular, migraine, are growing, and through the aging of the population, more and more people are affected to them. One out of two adults actually suffer from a chronic condition. Our purpose is to bring self-care, self-management to home in order for patients, people with chronic conditions to leverage, enhance their quality of life.

Climate change is a topic that is reality, and we have to act. I am 100% convinced that corporations can go into a leader position here and make a change out of Switzerland, for instance, by exporting technology solutions. Ypsomed is a leader in this space, in the space of medical devices, and we'll show you what we have done over the past six months with a clear target to become net zero. Access to biosimilars is a growth driver. More drugs are broadly available, which is important. Our purpose is to be the company that brings those products globally, also to countries where there is less resources available. Last but not least, of course, innovation and digital health.

Modern liquid drugs, more and more drugs have to be injected, and through digitization, we can finally work on adherence in order to support better therapy outcome. We have waited so long, but now with the asset of digitization, we can bring better care for people in self-care situations. Let me highlight a couple of elements, and I will dig in all of those elements a bit deeper during our coming 30 minutes. On YpsoPump, as you know, we have launched Assist with CGM Dexcom integrated. We are proud to announce YpsoMate On, our connected auto-injector. I will show you that. We have a very clear view together with Eli Lilly on the FDA path towards the U.S. market. We have been able to launch an auto-injector in the space of psoriasis. On responsibility and engagement, we are a founding member.

Actually, we are the initiator of the Alliance to Zero to deliver carbon at zero products to big pharma biotech. We have changed to renewable power since mid-2021, and we're also proud of that we have a really stable and reliable supply chain. We had no interruption over the past 18 months. We're always able to deliver, which is an excellent situation. We are in a comfortable situation where we have to expand capacity, both in Burgdorf, and we've also decided to build a factory in Mainland China. With that, I would like to spend a bit on our fundamentals, and then, of course, the figures. Our products are vital, and in both delivery systems and diabetes care, we talk about recurring business models. Once a company works with Ypsomed, they usually stay with Ypsomed.

Once a patient is on a pump, they continue to order the infusion sets and their supply. We continue to invest in new platform offerings, especially in the field of digitization. This is why we continue to invest and to execute our strategy. We invest in innovation, we invest in capacities, and we invest in our people. Important to see, and I'm actually quite happy, is that we finally spent more money on R&D and software and less money on concrete and machines. It's actually a good sign. Our total half year CapEx spending of around CHF 50 million, we're going to increase in the second half, end up with roughly CHF 110 million CapEx for the full year investment side. It shows that we have a clear focus towards R&D intangible assets and software.

This is exactly where I want to see Ypsomed delivering more building and spending efforts on products. We've also been investing in people, I've told you, over the past 18 months during the pandemic since the outset, 164 new jobs, so over 10% additional jobs. It shows we are very robust situation. We actually were able to hire a lot of very good people from other companies that join our team, our family, and we are able to grow, as you see, in all areas in Switzerland and abroad. Our key figures turnover, we have seen it this morning, 12%. On injection systems, over 13%. We are at the moment at roughly 18,000 pumpers with an EBIT of CHF 10.5 million for H1. Over CHF 20 million additional revenues in the first half year.

It is clearly showing that we have not been affected by COVID. It is clearly the result of our efforts on platform side on both delivery system and diabetes care. This is what we see on slide 11 here, that we have been able to deliver growth in all three segments. Ypsotec, so others is growing Diabetes Care and Delivery Systems. Let us now dig into the different segments, and I would like to start with Delivery Systems. Now I mentioned it is a recurring business model, so obviously introduced products continue to order. It's also important to mention we were able to launch new products, especially for UCB and Novartis in the space of psoriasis, a new field for us, auto-injectors YpsoMate that we're able to ship. We continue to have a good performance on project business.

We have been able to sign roughly 30 new contracts since the beginning of the new business year. An excellent track record, actually another record year again on delivery system side, closing new contracts, new deals for new indications. 13.2% injection system growth year-on-year, both in pens and auto-injectors and project revenue. Has always been driving the growth on the turnover side. Devices for clinical studies, devices for clinical trials that have supported here. More and more studies are starting, and of course this is very lucrative for us on that end. On contract manufacturing for Sanofi, a small decline, but actually on the EBIT bottom line, no real effect. Important for us obviously is our own devices, injection systems.

We have discussed last year the slightly weaker second half year, 2021, due to some delayed shipments of new drugs during the pandemic. We have clearly uptake now 118. That's what we have estimated half a year ago. This is not only the elements which have been missing in the second half of 2021, it's actually real growth. This is why we can really increase also our turnover estimation for the second half year. You will see in the guidance in a minute that we're actually increasing our turnover for injection systems to 30% in the second half year on average 20% for the full year. Really continue to grow in the space of own pens and own auto-injectors. Let us move to diabetes care.

Obviously, also here, we have a recurring business model with the consumables, the infusion sets, which is very robust. Now, COVID has slowed us down. Clearly, we have discussed that. But it's not only COVID, it's also our missing loop features that slows us down to bring new patients on the pump. This is why we have spent a lot of effort on that end. I'm very pleased to announce that we have found a strong partner with an existing CE mark loop app that will talk to our pump, so we can introduce looping already June-ish, July-ish, summer-ish 2022. Being much faster than originally expected. We see that not only patients, but especially also larger clinics are really demanding pumps that loop, even though a majority is still not using it.

It is a feature that patients want in the future. We have to bring this solution to the market, and I believe we have a good solution here ready to ship. Of course, apart from the loop program, it's our collaboration with Eli Lilly, a large program, full focus program. I'm pleased to say that this works very smooth and very well. Now turnover level, we have an increase. It's also due to development services. We sell, we have project revenues. We have a commercial sales increase of 9%, which is obviously not enough, but it is an increase. Test strips and diagnostics roughly stayed the same. A needle decrease we had in the U.S. mainly because of Walmart, but this is what we have announced to you already half a year ago.

Outlook-wise, we raised the expectation, we raised the guidance for the full year. I've mentioned to you the 20% growth in injection systems. It's even a much stronger second half year we see in pens, auto-injectors and projects. For the full year, we give a guidance of towards CHF 30 million EBIT operating profit. From CHF 18 million-CHF 27 million, we increase to towards CHF 30 million. We will see what the euro is doing. Over the past days, it has been a bit up and down. Now this will have an effect of maybe CHF 1 million-CHF 2 million. We will see how long this weak euro will stay remaining still. Despite of this, we can expect an EBITDA of roughly CHF 30 million.

With that, ladies and gentlemen, I would like to spend some time on our four strategic pillars, and I would like to start with innovation and digital health and just talk about a topic which is really important for us, for today and also in the future. This is the topic of adherence. You are very well aware that a majority of patients doesn't take good care because we are humans, we forget things, we are not able to do it. Then especially in the chronic disease area, this is of course a big, big issue. Huge costs, huge patient suffering out of bad adherence. Not because they don't understand how to use devices, but because they don't do it, and we really have to support them. We know we can only do that through digitization.

Now, the reason why people don't adhere enough are very diverse, but a lot of elements can be enhanced by giving better devices, better solutions in the hands of patients, and doctors, and nurses. This is why we bring connectivity into our systems. We have introduced to you already two years ago, SmartPilot. SmartPilot is an add-on that talks to the phone and to the phone to the cloud. We collect therapy relevant data such as date, time, successful injection, et cetera. Also temperature. This data is then supplied to the cloud and the disease management, the doctor. We also support on the application. We support the patient, especially with injections that you only do once per month or once per week. It's not such frequent things like insulin.

We support the patient on what he has to do to clean the site, to prepare yourself, put the auto-injector down on your belly and keep it on your skin until everything is in, not to have wet shots and taking the device out. Really strong support. Also safety elements. We can check if the medication has expired, if it's too cold, if it's too warm, and all these things. We gather all this data and put it in the hands of the patient, of the doctor, but also in the hands of disease managers in big pharma companies. I'm really proud to say that we have gone an important step forward here and present a new platform design. We call it YpsoMate On. YpsoMate On is the first prefilled disposable, fully connected auto-injector that we present to our clients.

It's a basic device that has connectivity built in through IoT. The nice thing is that you don't really have to pair anymore. The device finds the application itself. It talks directly, and it connects directly without the interaction of the patient. That's really important because patients always are a missing puzzle here, a missing element that can make mistakes. Now this doesn't happen anymore with YpsoMate On. The second good thing is that we leverage the existing YpsoMate platform, so we don't have to change our machines, our assembly lines. We can build YpsoMate On on our YpsoMate infrastructure because the team has just added a small feature. This is the electronic piece on the back of the device, including a very small sensors that measure what has happened.

They give a visual indication to the patient if it's okay to pull out the device. It has a Bluetooth connection that connects and sends the data from the device to the smartphone and the cloud. Very neatly done. What is also nice and I'm also very proud of is that the team has achieved to actually implement our sustainable thinking. It's our guideline on design level already, on concept development level already, that we built-in recycling capabilities early on. In the future, if devices have to come back because they have to be recycled, it's easy to disassemble, to separate the electronics from the plastic pieces. Inherent in our design is the sustainability element. With that, Ypsomed is the first and only company worldwide that can offer the full spectrum of connectivity devices in the autoinjector space.

Both SmartPilot, if you want to have more guidance, if you want to have more patient support, and then the simple naked IoT device that connects and ships the data. This is an interesting offering. We are having discussions here with our clients on that. With that, I would like to move to access and expansion. I have brought one slide for you on the mylife Loop. The mylife Loop program for pump here in Europe, because this is what is important for us over the coming three years. What is going to happen. We have launched mylife Assist, as you know. mylife Assist integrating the Dexcom G6 signal. It's available in a couple of countries here in Europe. We are rolling out more and more countries as we talk.

Beginning of the year, January-ish, we are launching mylife Dose, finally, which gives the ability to dose your bolus from your phone directly. You don't have to take the pump out anymore. It's a safe connection with a higher standard of cybersecurity that enables the bolus from your phone. What we have achieved and what we are already going to launch in June is mylife Loop, an interoperable app of a third party. I will announce the name in December-ish, maybe January. It's a third party app that is talking to our pump. It's fully connected. It will steer the pump, it will loop the pump. The good thing, it's already a solution that is available CE mark in Europe. It's not broadly available yet, but we will make it broadly available. It's going to steer our pump.

It's important that Ypsomed is pulling up and coming up to Tandem and Medtronic here delivering loop features for patients and users of insulin pumps, and that's an important step. In mid 2023, we're going to deliver the TypeZero solution with Dexcom, as we have planned for a long time. We think we cannot wait. We have to bring it now. We have to bring this solution to our patients. Let us move to delivery systems, and I would just like to focus on one topic, which is the move from IV to subcutaneous formulations. Now it's clear that drugs have to be injected, no longer pills. Molecules become more and more complex.

It's also clear that more and more drugs go biosimilars of patents, so more companies are working on hormones and MAbs, and we are delivering devices. The new trend is really the trend from IV to subcutaneous. More and more drugs are moving from hospital to home. This is exactly where Ypsomed is in. This is our business. This is a self-care business, and this is what we are delivering. One good example, of course, is COSENTYX. COSENTYX is a drug that supports and relieves people with the condition of psoriasis. Psoriasis is a skin disease that is mainly inherited. You have red spots with silvery scales around. It's extremely itchy. It comes and goes, but it's a lifelong condition, and you can really treat it only with medications such as COSENTYX.

UCB mentioned has a great formulation here, and we are proud to say that Ypsomed is now here partnering with Novartis on this drug, delivering a great solution with one injection per month. On an excellent new solution. For us, a new field that you see here, we are now moving also more and more in new fields, in new disease areas, in new indications. We have presented to you last year, asthma and migraine as the indications. Now we have psoriasis, the first device is coming. If we move on, and dare to look a bit outside and dare to talk a bit about our pipeline and the deals we have signed and the projects we are working on. As you know, we are working at the moment at over 100 device projects in parallel.

Many of them are in new disease areas. Obesity obviously is a big topic where Ypsomed will play a major role in delivering devices. Alzheimer is a big topic with two to three big players, where Ypsomed will play an important role to deliver the device, to bring the application to people with Alzheimer at home. People no longer need to go through IV at the hospital, but to really deliver the drug at home through auto-injectors. Many more diseases are coming also in the space of oncology, and it really shows that Ypsomed is not a diabetes-only company. We are really a company that delivers drugs and that delivers successful therapies. That's exactly where we are focusing on the whole spectrum of liquid drugs and people with chronic conditions.

With that, I move to platforms and operational excellence because all of that is only possible because we continue to invest in new platforms. As you see on that slide, we have added two new platforms, YpsoMate Zero and YpsoMate On. In the space of auto-injectors, we are obviously also increasing our activities in the space of YpsoDose. Large volume injectors is our first project, running very well. It's a new device class that will bring us revenue product in the market in 2025-ish. That's the next big step for Ypsomed with larger volumes. The logic on how we work remains the same since the inception of our platform strategy. Ypsomed continues to do upfront investments in R&D. We continue to invest in manufacturing infrastructure.

Once a client comes to us, once they have a new drug, when they have a new project, they start at the level where the risk is much, much lower, and their time to clinic is much, much shorter. The same principle applies as we have started with that over 10 years ago, also for new platforms. When I have told you about our 30 new projects that we have signed over the past seven months, 70% of them are actually from existing customers. We are now working with 27 out of the top 30 pharma companies worldwide, and if they have a need of a new device, if they have a new molecule, they simply order a new project, which makes it, for both sides, extremely efficient. Now, those new devices, those new projects, of course, force us to invest in capacity.

This is why in the board, we have decided to order another large line for Ypsomed. We have talked about that in the last call, which will be installed in Schwerin. Two weeks ago, we have decided to order a large line for UnoPen, so for disposable pens, mainly for insulin, that will be also installed in Schwerin, tripling our current volume from roughly 40 million to over 100 million pens in that space. UnoPen will be an important platform also in the future. We have also decided to invest in our own site in China, mainly because Chinese clients demand to become closer to China. There's a new model from central government called the volume-based procurement model, which is actually supporting Chinese pharma companies.

I have a strong feeling, and especially if I talk to our colleagues in China, if we do not become Chinese, we will not ship devices anymore in 10 years. It's a clear step for us towards this very important market. We have now over 20 projects in China ongoing. We are number one company that to deliver pens to China, and this market is just starting with open checklist. It's just, I mean, it's just starting on biosimilar side, on natalizumab, on Enbrel, on more and more and more drugs that are going to be delivered to people in China, Mainland China. Ypsomed will play a crucial role here. We have the final selection of the site ahead of us in Shanghai or Suzhou area in the coming weeks.

We're slowly coming to an end here, and I would like to finish with our activities in sustainability. I've explained to you Ypsomed Zero last call. It's a clear commitment to first substitute and then compensate. Substitution means we continue to research, to do R&D in new materials, to try to exchange material types with material that has less carbon footprint. We will always remain with some carbon trapped, obviously, because it's a device, and this we will have to offset in the future with certificates. We have also decided to only consume electricity and power from renewable sources as of this year. In Switzerland, obviously, that's not that difficult. We have a high amount of water energy, but for the rest of the energy we need, we are buying certificates to be 100% clean on that space.

You may have read what is also important is we have been launching Alliance to Zero. It's a club, it's an association of players in our space, the whole value chain from glass manufacturers, rubber manufacturers, fillers, logistics partners, but also of course, obviously Ypsomed, the company that delivers the device. Our promise is to deliver to the whole chain, to the whole organization, to the whole chain and whole customer pharma customer side solutions without carbon net zero. With that, ladies and gentlemen, I would like to come to an end and would like to summarize what I've explained to you over the past minutes. Now, I'm proud to say that we have delivered. Our H1 is according to our expectations and that we are able to increase the guidance for the full year.

We clearly show that delivery systems works well, that we deliver on our platform strategy and that we even increase our reach through entering new indications. On diabetes care, we have also shown very clearly that we deliver, that we have a clear path towards Loop and a clear commitment towards our partner, Eli Lilly in the U.S., with a clear view to start that business in 2023 with our partner, Eli Lilly. Thank you very much. With that, ladies and gentlemen, I would like to hand the word back to Thomas. If you have questions, we are still around. Please feel free. Thank you for your trust and interest.

Thomas Kutt
Head of Investor Relations, Ypsomed

Simon, thank you. Thank you very much for this very interesting presentation and explanation to not actually only our figures, but also about our strategy and main topics we are focusing and drivers and fundamentals. I'm now looking really forward to the questions of our audience. Gabriela, may I ask you to open the lines for questions?

Operator

Yes, thank you, Thomas. Ladies and gentlemen, you have now the opportunity to ask questions by dialing star fourteen on your telephone keypad. At your turn, you will hear a short announcement saying unmuted on your line. Star one four for questions. Please dial star one four for questions. We have no questions at the moment.

Thomas Kutt
Head of Investor Relations, Ypsomed

Yes. Gabriela, so I would like to say, thanks for your support and kind help with this conference call. Of course,

Operator

Sorry, Thomas. We have one question.

Thomas Kutt
Head of Investor Relations, Ypsomed

Okay, please.

Operator

Now.

Thomas Kutt
Head of Investor Relations, Ypsomed

Go ahead.

Speaker 4

Well, yes. Hello. My name is Michael Riester from Broker.ch. Hello, can you hear me?

Thomas Kutt
Head of Investor Relations, Ypsomed

Hello. Hello. Hi. Hi, Michael.

Speaker 4

Hi. Hello. Yeah, I just one question. I've seen that you want to introduce the YpsoPump now in the U.S. in 2023. As I understood, the last guidance today was 2022. Can you explain a little bit why you have this, why you have changed this planning?

Simon Michel
CEO, Ypsomed

Thank you Michael for the question. Obviously, we are here in a very close collaboration with Eli Lilly, and Eli Lilly is driving here. At the end of the day, it has to be one strong proposition and this is what we are working towards. In the end of the day, we may have a delay or a small shift on delivering pumps of a couple of months, but it's much more important that we deliver the whole file towards the FDA together in a strong manner. It's quite complex because it's not only elements from Ypsomed on the pump side, it's also elements from Eli Lilly that have to be delivered together as a package.

We have decided together to go that way and have a strong one-step clearance here with the FDA in 2023.

Speaker 4

If I may ask second question. You mentioned two times the UCB that they also have a strong product for psoriasis. But I'm not sure if you mentioned it. You are also delivering the Ypsomed for UCB or just for Novartis?

Simon Michel
CEO, Ypsomed

No. It's actually I just picked Novartis. Both companies have existing drugs out there. Actually, I cannot recall the name of the UCB drug, but we are delivering auto-injectors for both Novartis and UCB.

Speaker 4

Okay. Understood. Okay. Thank you very much.

Simon Michel
CEO, Ypsomed

Okay. Maybe just one, I would like to add one comment. You can refer to our half-year report, semi-annual report. There we have a very nice report about our collaboration with UCB and the drug and the formulation. They are now approved, and we are very proud and feel privileged to provide the device. I think the pump question on Mr. Riester's questions here from [MainFirst] is actually quite relevant, you know. On the other hand, if you look at our coming two, three years, our strong focus, and this is what we have to work on, is Europe. I mean, our duty is very clear, our job is very clear. We have to double in delivery systems and bring diabetes care to net zero in two and a half, three years.

This is exactly what we are working towards. I've always been extremely clear that U.S. is not part of that becoming healthy. We have to become healthy also without the U.S. The U.S. is on top of that. It is kind of the growth driver for Ypsomed as of 2023, 2024. I mean, what is important to mention here is that we have a very clear view how we deliver pumps and loop systems to our clients, to our patients, in Europe here over the coming 24 months. Okay. Any other questions?

Operator

No, there are no more questions.

Simon Michel
CEO, Ypsomed

Excellent. Okay. Thank you, Gabriela. Thank you, Thomas. Thank you, Michael, for your support in explaining our performance. So if you have any further questions, of course, I'm here to support you. I'm always at your disposal for further discussions. For today, I wish you a nice day. Gabriela, may I kindly ask you to close the lines.

Operator

The conference recording has been stopped. Dear participant, your conference call has come to an end. Thank you for attending. Goodbye.

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