Transcription
Mano Iyer 0:06
Thank you very much. All right. Wonderful to be here. It's such a talented and distinguished group of investors, perhaps best to start on the far end with Murielle, if you wouldn't mind, introduce yourself and your, great, thank you.
Murielle Thinard McLane 0:18
Thanks, Mano. Murielle Thinard McLane, I'm a director at Intuitive Ventures. So we're the strategic venture capital arm of intuitive and we invest in series A and B, we have $100 million asset under management, a Series A and B in medtech, broadly, digital health and diagnostic, really looking at expanding the ecosystem of minimally invasive care. I'm actually an operator and an entrepreneur by background so I've been in your seat.
Janke Dittmer 0:49
Hi there, my name is Janke Dittmer. I'm General Partner at Gilde Healthcare lead the European Health Tech activities. So that's medtech, digital health, diagnostics, and life science tools. We are transatlantic venture and growth capital fund with two and a half billion under management. We just raised our six fund close to 700 million euros. And I think you know, being transatlantic is very close to our heart as our investment thesis we have an office in in Boston and representatives across the US. In Health Tech, we invest about one half of our funds in the US and the rest in Europe. I'm originally a scientists turned entrepreneur turned corporate venture capitalist, a bit of consulting in between now for for 12 years been doing this. And as you will find out to have some history actually with some of the people on the panel here.
Sasha Berger 1:49
Well. Good afternoon. My name is Sasha, I'm a general partner TVM. TVM Capital is a fund with with a long history. We also in this business for 40 years. Right now we're investing out of half a billion dollar fund with a transatlantic team. So team members in North America and in Europe, I personally based in Munich, and we're investing a significant portion of that capital into devices, and other late stage opportunities and diagnostics and digital health. Typically 10 to 20 million would be our preferred ticket size. And my background is in chemistry, and finance. And I've spent 10 years in different industry roles before joining TVM seven years ago.
Mano Iyer 2:44
Thank you Sasha. I'm an American has been bouncing around Europe for a long time. So not sure where home is anymore physically based just out of Amsterdam right now. With Sofinnova. So we're 50 year old venture capital firm but 500 companies invested since 1972. 2.5 billion Euros assets under management right now. 100 active portfolio companies, six different funds from early stage medtech to late stage life sciences, including industrial biotech and a new exciting digital medicine fund, my partner Simon Turner's on a couple of panels here. So exciting new opportunities there, I think is everyone's looking at digital these days. So want to make this useful for everyone. I'm an entrepreneur at heart. So most of my career doing that, and want to build off of the friends on the previous panel to expand the scope from from Europe, to the US as well. And maybe the caveat here is obviously we know that neither the Europe nor the US are homogeneous from a cultural standpoint, personality standpoint, or healthcare delivery model standpoint. But let us proceed to grossly oversimplify things, just from a show of hands from an audience standpoint, who's who's raising money right now? It's anyone raising money? Alright, half the audience is in denial because you're actually always raising money. You just don't know. How many folks are in Europe, from Europe and keep your hands up. How many people are having a hard time raising money and okay, well just want to get a sense of things. Just from my entrance to lunch about an hour ago, I bumped into four different I think entrepreneurs and I got the full range of the markets not so bad. The markets, okay, the markets harsh, and I'm not sure what the market is right now. So we'd love to ask all of you your perspective, obviously, we came out of 10 12 13 years of exciting growth, you know, had easy money, SPACS, you know, the world was going really well up until 2021. We ran into a wall of, you know, inflation, insolvent, bank insolvency, you know, global political issues and so forth. But you just announced your funds, we're all actively investing out of funds. So what's what's the state of investing in your perspective and medtech and Murielle you might have You're you're with intuitive it's a, it's an internal fun, but maybe we can talk a bit about your perspective, you're being the only one in the US at the moment.
Yeah. So for us, I would say we shouldn't say we love it. But it's actually as a Strategic Fund, we tend to be more conservative, maybe that's some of the froth that we've seen in the last few years. So this has been a great time, we've been very active. And so we continue to invest and see a lot of really, really good deals. So we'd say, there is money. Most of our portfolio, we have nine portfolio companies right now, five of them raised this year, we've seen them having no problem raising, even at better evaluation unexpected. So money is there, it's really about presenting differentiated ideas to people like us. And I would say, as a strategic being in a more rational timeframe, from an investor standpoint, is really helpful. And you'll see, we're working with a lot of active people, such as people on the panel, and as long as you're presenting correctly, your idea, you'll you'll you'll find interest, it may take a little longer. Rounds are closing taking, we're taking a little more time and due diligence. But the rational money is here and here to stay.
Janke, you've done a wonderful job raising funds difficult times easier times. Now, again, COVID. And this year, you guys have done an amazing job raising funds. What's your perspective? Now you've I mean, you've invested in early, late US/EU things change for you.
Janke Dittmer 6:36
I think raising, raising a fund is always difficult, right? That's for sure. But if I compare the four fundraising that I've I've done in 2009, and 2015 16, and then 2020. And today, clearly, the 2009-11 was the hardest. Even though we already this was our third fund, we had a long history as an institution at the time. I think the 2016, one was the second hardest. And it turned out to be very good vintage. The 2020 race was the easiest by far. I think for the first time doing it all by zoom, we were done in three months, you know, raising over 400 million. And this time, I think it became harder again, but I think there's still money out there. So that's on the, on the fun side. For the for the companies, I think we are in a very unique situation where there's entrapreneurs out there that actually don't really remember the the old times good or bad, but the normal times. And if if I kind of just cut out the 6 trillion that were injected into the US economy between 2020 and 22. And look at the effect of that, which could no go nowhere, except for a few sectors, including health care. If you take that anomaly out, we're sort of back to sort of the old normal. So we're back on top of the good times of pre pre COVID. But it's not treating every sub sector equally. I think that's really important. And even within medtech, which is what this conference is all about. I think it's become a lot more selective. I think in 2021 2020, we saw a lot of companies get get financed. And now I think the really good companies are still finding it not too difficult, it's competitive. But if you have difficulties in your your your business model, you don't have reimbursement lined up, you know, it's it's it's really challenging, then the fundraising has become much more challenging for those companies
Mano Iyer 9:04
Just covered the rest of the panel, new topics, but we'll come back to that. Such what's your perspective here?
Sasha Berger 9:09
Actually, I think that's, that's totally awesome. My perspective, the markets are more rational maybe these days to to the common as Janke said. Before I think there were a few years of irrational markets. So everyone was was chasing deals, it was extremely competitive valuations were not necessarily based by fundamentals. So we had a challenging time also investing because we were we're not moving with the flow, so to say so, for us. Getting back to let's say more normal markets actually is a is easier now. discussing with founders next steps being and rational about spendings. How to how to invest cash rich and all those elements, which were basically not a point for discussion two years ago, because the next IPO was just half a year away. So I don't think it's a bad time today. But I fully agree with Janke, it's become more selective. So those companies who are fulfilling a lot of these typical criteria will will find investors, it may take a bit longer, but they will find them. And for those companies, which were maybe more, more ambitious more, and have not standard business plans and elements, which which are certainly more risky. That that's, that's more challenging to find a broader set of investors these days.
Mano Iyer 10:57
So you've all touched on, obviously, the entrepreneurs from some standpoint, we can dive into that a little bit. I mean, from a and of course, building on the previous panel, you know, the cultural differences here. I mean, we're so to juxtapose EU versus us. And I mean, there's imagine some some elements of valuation here. Right? And the discussions you're having, and what you find is an attractive investment to make. And do you feel like there are differences you've experienced in as you talk to founder CEOs of these companies? And is that part of the challenge from from a valuation standpoint, or other cultural differences? Do you think that you found have come up in these discussions more recently, that may be different from from before, or characteristics of these conversations, I don't know if Yanke, I'll go back to you,
Janke Dittmer 11:41
I'm happy to start be a little bit provocative. We have the story that, you know, when we have companies pitch should at our office, and this European entrapreneur, you come out with, you know, totally drained of energy, and you think like, oh well, it's going to be really hard for these guys. And then someone, you know, in the maybe the associate in the room and sing but you know, that IP that they have, I think that could be really key. And somebody else will say well, but the clinical data, I think they were really smart about how they set up their RCT. And I think they're gonna get there and then think, well, it's actually not so bad. Let's have another look at it. And then you got the American company are present, and we're going out fully energized. Wow, super, super presentation really impressive. And then you walk out to the meeting. And then again, the same associate said, but did you look at the IP, right? And you know, what about that reimbursement code, there is a code, but no, you have to toggle and it's never going to work, right. And the whole thing sort of starts crumbling down. So I think sometimes it would be good to have sort of more of that sort of optimistic spirit on the European presentations, entrapreneurs being more daring, you know, more aggressive in their growth plans. And, you know, inject sometimes a little bit more realism in the the sort of slick presentations we see from the US. That's the stereotype, it is surprisingly true still, although especially in digital health, which we also invest in, we see that there is a new generation of super international leaders that are much less distinguishable. But entrapreneurs, in medtech are much more mature. And that this distinction is still very, very much alive.
Mano Iyer 13:34
I mean, when the challenges here from traditional medtech digital health, if you will, is the experience of the team, right? I think there has been there's been a dearth of that really senior executive talent in Europe for a long time. I think that's changing. It's improving in different pockets around Europe. Of course, we have the pockets, you know, in the US, I mean, Murielle, what are you seeing, as you invest? You know, from from a US based fund here, how do you think about, you know, as you invest in teams in US versus in Europe, and how do you kind of compare contrast the experience that you're seeing?
So medtech, digital different. I would say, first of all, so I'll echo what Vijay said. So the in the digital health ecosystem, it tends to be very young CEOs that are in Europe and want to conquer the world or conquer pan Europe. And they're usually we have discussions of what that may mean over time, and that they may not be the CEO forever. And that's a really important part of our evaluation criteria is seeing who can take the company to where and how willing are they to work with us to kind of get to the next expansion. On the medtech side. In Europe, there's there's an ecosystem that's been here for a long time on the technical side. And the question then becomes how do you augment that to go to the US so it's not sufficient to just have one employee in the US they're just a commercial, and it's not how success has been built? So again, lots of discussion of how they thinking about the US and for us, it's about how the team can grow to the US market. And how can we help them think about it, particularly around, you know, regulatory, which the panel refuse panel was talking about, and then also from KOL, and sort of go to market deployment.
I mean, from an entrepreneur standpoint, maybe I can bring up my own experience here, which actually had with Janke, Gilde, about four or five years in, we received a term sheet or we had a framework for a term sheet in place. And, you know, when I started the company, I had an honest conversation with Antoine at Sofinnova, saying, well, at some point, I may not be the right person to run this company. That's okay. And then over the course of the next few years, you have many near death experiences, and you're humbled in many ways, and, and what what was left of my ego was further trampled upon when you know, Gilde said, Well, you know, we'll invest in record, but I think we need to find a better CEO or a better wasn't the right word, I think, you know, someone with more experience, which I think was appropriate, and it was absolutely fair, right, and looking ahead, and what was needed for the company was someone who had that commercial experience and looking ahead to raise a lot of money likely in the public markets. But when it actually hits you in the face, it's it's a different situation than when you're trying to think about it and plan for it upfront. So I'm curious I mean, conversations you've had I know Murielle, you came in actually, you brought in as someone with with operating experience, right to replace the existing CEO? So are you having these conversations with your with your, you know, potential investments or investments and with with founders, or CEOs who you think may need to be replaced in the future, and it's a very sensitive topic and a challenging one out Sacha, you face this?
Sasha Berger 16:32
Of course, I think every investors face that. And as you say, it's a very sensitive topic, for obvious reasons. So what we try to do is have an open conversation before we invest, because I mean, that's part of the thesis. So to say that we we also well review the the management team and the capabilities and then see what from our perspective would be a good way forward. And at these tests, at that point, the willingness of people to either step back or step aside, it must not necessarily be that that you leave the company, right, but maybe that you just step aside, and you bring on board somebody else who can, who can take on the company for the next the next development phase and bring it to the next value inflection points. And that works good or are not so good. And that's also an indicator whether we want to invest or not. So if that is already complicated, when you talk about it, then most likely will not be easy if you're in the company, so that most likely we will rather shy away from it. But maybe just from going back to that European versus US perspective, sometimes there's that's the great idea to to have a European company entering the US market. And as I said before, you need people on the ground and the US so maybe hire a US CEO for that type of operation. That can be very good. We had examples in the past where it actually worked extremely well. But it's it's also challenging them from an intra company cultural perspective, right, having someone who's maybe brought in was a bit detached sitting in the US trying to move that company to become more us focused is not an easy task. So on paper that sounds great, because it does everything right it's it's the the European r&d and basics and the US capital markets focused CEO but that's too often just the dream to be honest, then then reality to make that happens. So
Mano Iyer 18:56
Janke, have you have you experienced it as you've I mean, you've built a scaled companies from Europe to the US. I mean, what's been what's your perspective here?
Janke Dittmer 19:04
There's no formula for making it happen. I think the old adage, if you want to really understand the market, you need to immerse yourself and it's still true. So I've admired founders who have basically packed their bags and said, Okay, I need to go to the CEO. I'm actually going to move there. And by and large. I mean, they, they did pretty well in doing so and learning. The other part is like the the sort of courageous conversations that need to go on at the board level and in a one on ones with the founders before you invest while you invest. I think we've come out of a period that was very founder friendly, where I think some investors have shied away from those conversations. And it's not always easy in the best interests of the company and the founder, actually, themselves. So I think this is something that for the entrepreneurs in the room, it's important to look out for that you don't have someone who just agrees with you, but you know, basically brings, you know, in that situation sort of truth to power, you know, that's really important that somebody is authentic tells you something that you may not want to hear at that point in time. But then you find a solution together, whether it's via, you know, coaching, or support, you know, like, sometimes you have a really good CEO, but he can't take the company all the way, well, then you put in an executive chairman, and you put in a COO next to them, who've done it before. And together, the three of them can actually make it or you basically have a Chief Commercial Officer, who kind of becomes the external face of the company and more of COO who's the internal face of the company. So all of those creative options are possible. What I've seen in the last few years, though, is that there's increasing maturity of the entrepreneurs in Europe, where they actually realize that maybe they're not the right kind of profile to scale up the company, and they come to that conclusion, because they're large shareholder, they want to be successful, they want the company to be successful. And that makes the transition, you know, much more collaborative. You know, ultimately, as I think there is data showing that 90% of the early stage CEOs will not be the right CEOs for the scale up. And I think just speaking that out is not failure, right? You've taken the company to where it is, today. That's a great achievement. And now it's a different stage, maybe you can stretch yourself, put a lot of the company CEOs and founders that I've worked with actually don't like the scale up phase anymore. So, you know, it's, it's actually very different. So I think that's a very important conversation to have. And, you know, if you have none of those conversations, right now, you need to maybe think about getting other investors into your board.
Mano Iyer 22:11
It's actually really well said, and I have to close the loop on our story. I mean, I think it was the best decision I ever made to step back and find someone who had a lot more experience, I learned a ton from him, Andy Weiss. And we can mentor to me, and I realized, I really love early stage med tech, and then the governance of is critical in building and scaling a company, but maybe that wasn't necessarily for me. So it's difficult in the moment. But I mean, I think having that objectivity as an investor is critical and being able to engage in those difficult conversations, everyone, maybe we can shift to business models, to some degree, it feels like, and you've touched on a little bit with regards to, you know, there's there's a lot more money now in Europe, you know, through grants and other aspects and just venture capital funds investing, of course, during the intro, they mentioned a lot more money is being raised in the United States. But from a traditional, say, medical device, therapeutic standpoint, you know, the model is to go do your first in human study in the East, East east part of Europe, at least the countries that are open, and then go to the US because the US is open, it's you know, it's a centralized market. It's FDA is very friendly. And MDR is great and messy. And then if you get through that process and gets CE marked, you still need to navigate, you know, country by country reimbursement, right. So Europe is not homogenous anymore. I mean, is that is that the model? I mean, what's the what's the counter view? What's the what's a better model? What are you seeing as you as you look for investments in these areas?
Yeah, so we're seeing a lot of that model those days, frankly, and the one of the thing that we've seen though, is a lot of European companies think they can take their first in human from US, from sorry, Eastern Europe, and then bring it to the US and say, Hey, we can use some of that, and in reality, no, it's it's early signal, but then you need to replicate everything back. So there's still you know, sort of that that hurdle or that education that we're seeing. But by and large, for us, we're seeing a lot of companies that are bypassing Europe and going directly to US. And frankly, because of where we are also, US market is one that we look very, that we'll look up, it's how that company will scale in the US. And reimbursement is an interesting one, because people tend to think, well, the US is one market, right? It's not, far from that. And you can go at it different ways, depending on where you're selling to Health System, IDN or you're selling to so at risk system, are you selling to Medicare, or is it going to be a private payer? So there's a lot of education that needs to happen as well as our as the companies are going to tell us that they may think about how they position themselves, both on the digital frankly, on the medtech side.
Janke, you have experienced you're also right in terms of these traditions kind of medtech therapeutic business models, which what's your experience up until now? And how are you concerned? From a valuation standpoint? You know, how do you how do you think about investing? For at what stage? That? What are the clear? What are the clear milestones, if you will? And I don't know, what's the role of strategics? If you want to kind of throw that into the mix here?
Janke Dittmer 25:17
Yeah, I mean, it's a big question. But I think over time, you see a back and forth here. So when, when I entered the VC world, the FDA was really difficult. And, you know, everyone tried to avoid the FDA as long as possible, and, you know, try to maybe be can be acquired on based on European approval, European revenue. And actually, a lot of medtech investors when we went back into health tech and medtech actually exited the space, because they felt like this is this is impossible. So that's not so long ago, right? We're talking 15 years. And, and now it's, we're in a different phase where, through, you know, all sorts of questionable reasons, you know, you can't fight fraud with with regulation, in my view, but you know, we are and ending up with a bunch of rules in Europe that are almost as tough as the US in some ways, maybe even tougher, and then a lot of execution challenges that hopefully are transitory in nature, that we don't have enough notified bodies. And there's less predictability right now in terms of the pathway length in Europe, then they use their there ever used to be in the US, right, even in the worst times. So we've come to a point where recently, we had a company proposed to us that they would go to Europe first. And they got a lot of pushback, right, you know, so what's the investment case around it? It's really sad. As a European citizen, I feel like you know, we're letting down patients all over Europe, because they're not going to have the newest and the latest devices in five years time. This cannot remain like that. It's just we have to do something. I'm convinced that we'll find a way to make the pendulum swing, swing back. But for now, right, it's really difficult, I cannot advise a company to go into this sort of uncertain adventure in Europe, when the market is bigger and more straightforward. And there's an EFS and there is a breakthrough designation, and all sorts of accelerated paths to go to the to the US. I think at one point, I think the strategics will come in. And then I hope that will happen soon, where they say, well, most medical device technologies will not be profitable only on the basis of either the US or Europe alone. We need to be transatlantic. And I think that thinking will will, will come back. And if you haven't done anything on MDR, for for last five years comes the time of acquisition. Today, they don't argue that way. But I think in the future, there will come a point where they say, well, you haven't done your homework, we're going to basically pay less. So we cannot forget about Europe. And I would urge people to to keep it at the back of their mind. But it's it's a temporary crisis that we're in right now.
Mano Iyer 28:25
Do you find it other that there's so much money now that is being invested in Europe, and countries are giving so much money in grants, but there doesn't seem to be tracing of where that money is spent? Because ultimately, if everything is going to the US then it isn't benefiting European citizens? Right. And there seems to be a disconnect between the folks who are making those grant decisions and and ultimately seeing where, you know, accountability for where the money spent. But I mean, you think it's temporary accounts reviewed with regards to MDR? Does anyone see clarity on the horizon with regards to what's happening from a regulatory standpoint? Optimism folks. Well, but there's also an element there younger that you touched on with regards to what therapies are you actually creating, right? And how does that get implemented in different healthcare systems, and that's where it can also be country, by country and even within the United States is different. I think from a traditional, you know, medtech therapeutic standpoint, maybe it's clear diagnostics can be challenging digital health. I don't know if there is an established model yet. I heard I think Scott Huenneskens is I think he's in the, in the audience. I think he had a really nice quote, on podcast recently. He's saying, you know, one of the major frictions in his career was the challenge of making good choices versus economic choices, right, Scott? I hope I got that right. of you know, just because you have a you have a good therapy doesn't mean it's economically viable for the hospital and I think it took 20 years for volcano to to get adopted. And so there's also that do you have that assessment in your mind? In your investment thesis when you're kind of looking at these models, you know, from from a traditional metrics standpoint or digital health standpoint, you know, how do you think about it? Since digital health is still still new, right, you've got, you're lacking on the IP side up front. And on the back end, you don't have the exits, you don't have the clinical validation yet. Do you want to tackle the medtech side?
Janke Dittmer 30:19
I'm happy to do that, although also covered digital, of course. But, you know, I think 10 years ago, most people talked about regulation, and how to get FDA approval. And there was very little attention to market access reimbursement, especially in the early phase, I think has completely changed. It's almost like the first question, the second question that comes up in a presentation nowadays is like, how does that fit into the current reimbursement landscape? How does the business model work? How the incentives aligned, and I think it's, it's, it's really good, because we have to be realistic, right, we want to have a profound impact on patients lives, we want to make patients lives better. But if you have a therapy that the system has no way to pay for, it's never going to get to patients. So technologically, may be very effective and very functional. But if you don't have a way to bring it to patients, it's never going to fly. So it's just as important as the clinical data is to do your homework on the reimbursement side. And, of course, you know, it could be that you have to create new codes that you have get new coverage, new new payment models. But you know, you better start early, because those things really take a long time, you better build them into your clinical trial design that you have a healthcare economic studies that have alongside it. And it may be even satisfies both US payers, not just you know, CMS and private, but also European payers requirements, so that you don't have to do everything sequentially. And I think they are we've made a lot of strides forward, the industry as a whole, and investors have become a lot less naive about, you know, how to get paid.
Mano Iyer 32:05
So I think you just spoke to, you know, the need for a lot of money. Right. So maybe bring this back in last couple of minutes. We have back to back to the beginning with regards to the need for large amounts of capital. And I think, obviously, there's major headwind now with regards to, you know, US markets being challenged. I mean, there have been some some IPOs, think recent SPAC, so money has been raised in Europe. I think I know that we had discussion preparing for this with regards to what the the European public market system should be like. And I think there's there's there's different views here. I mean, so should you want to comment, I mean, with regards to your views on public markets, that the availability of an IPO market and really being able to build and scale companies here in Europe, I think you've got, of course, the large strategics in the United States for a long time now. And you haven't had that presence here in Europe. But don't we want that? Do we need that for the long term viability of of our, you know, of our medtech ecosystem?
Sasha Berger 33:06
Yes, we do. But I'm the same as Yanke said, I think we, we all have to be realistic and opportunistic, and work with the environment we're we're working in right now. So yes, I mean, there's there's, there needs to be things done. And there are activities ongoing with the respective regulatory bodies. But I mean, we have to work with the environment we're in. And so I think the best advice is to take the chances which are there and not complain about what could be right? If If so, that's not very entrepreneurial, so yeah.
Mano Iyer 33:45
To create the future, right isn't our job to create the future and create the environment that we need? So I don't know, other views on?
Janke Dittmer 33:52
So I think we need to definitely upgrade the European capital markets. There is some nice beginnings with Euronext, NASDAQ Nordic and but it's not enough, and we're not competitive with the US there. And it's a real disadvantage in the good times that we've had. But even in the in the in the bad times. At the same time, I think it's not so bleak. No arm has shown there is actually an open IPO market right now. If you think big, if you get companies to scale scale that is predictable. You can go public even today. Whether it's a good idea to be public company, that's another question, but you can actually raise a lot of money there. In the US, I think in Europe, we need to really improve things to compete.
Mano Iyer 34:40
Great, thank you. I think we're wrapping up. I think the panel is open for questions. We might hang out after this. If anyone has questions. Any final advice for folks in the audience?
Murielle Thinard McLane 34:50
I'll go back to what Yanke was saying around incentives and alignment. I think that's really, really important, at least in the US to understand it and it's not straightforward being in digital If you're selling to employers are at risk, they have insurers have lives for two and a half years. Something to keep in mind when you're designing your product. When you sell into hospitals, how are you going to use like for the OR how much are you going to create some profitability and in addition to reimbursement so I think as you're looking at US investors, that's one of the first question. We'll look at IP behind. We'll look at the regulatory environment, of course, but how do you align incentives across the ecosystem is really important.
Mano Iyer 35:32
Great point. Thank you. Stay Hungry. Stay Foolish. Thanks, everyone. Enjoy the show enjoyed Barcelona. Thank you, everyone.
Mano Iyer, a serial entrepreneur whose ties with Sofinnova Partners stretch back more than 15 years, rejoined the firm in October, 2022. As a Venture Partner, Mano investigates global medical device investment opportunities across the Sofinnova Partners platform of strategies, with a particular focus on helping the firm’s in-house medtech accelerator, Sofinnova MD Start, incubate world-class companies
Mano Iyer, a serial entrepreneur whose ties with Sofinnova Partners stretch back more than 15 years, rejoined the firm in October, 2022. As a Venture Partner, Mano investigates global medical device investment opportunities across the Sofinnova Partners platform of strategies, with a particular focus on helping the firm’s in-house medtech accelerator, Sofinnova MD Start, incubate world-class companies
Dr. Sascha Berger is a Partner at TVM Capital, based in Munich, Germany. TVM Capital is one of the transatlantic Life Science Venture Capital pioneers, investing with teams in Europe and North America. Sascha joined TVM Capital in 2016, helped to raise the current $480M fund, and works closely with entrepreneurs and founders to advance promising pharmaceutical assets, medtech, diagnostic, and digital health technologies to the next value inflection points. Sascha is a passionate VC, a Boston Consulting Group alumnus, and has an academic background in chemistry and finance.
Dr. Sascha Berger is a Partner at TVM Capital, based in Munich, Germany. TVM Capital is one of the transatlantic Life Science Venture Capital pioneers, investing with teams in Europe and North America. Sascha joined TVM Capital in 2016, helped to raise the current $480M fund, and works closely with entrepreneurs and founders to advance promising pharmaceutical assets, medtech, diagnostic, and digital health technologies to the next value inflection points. Sascha is a passionate VC, a Boston Consulting Group alumnus, and has an academic background in chemistry and finance.
Entrepreneurial investor with experience in: Growth Capital, Venture Capital, Corporate Venturing, Entrepreneurship, General Management, Strategic Marketing, Strategy, Business Development, Innovation Management, Research & Development; in the following Industries: Medical Devices, MedTech, (In vivo, In vitro, Molecular, Companion) Diagnostics, Digital Health(care), Healthcare IT, Consumer Health, High Tech, CleanTech / Renewable Energy
Entrepreneurial investor with experience in: Growth Capital, Venture Capital, Corporate Venturing, Entrepreneurship, General Management, Strategic Marketing, Strategy, Business Development, Innovation Management, Research & Development; in the following Industries: Medical Devices, MedTech, (In vivo, In vitro, Molecular, Companion) Diagnostics, Digital Health(care), Healthcare IT, Consumer Health, High Tech, CleanTech / Renewable Energy
Vijay offers a unique perspective as Optum's only medical doctor turned investment banker and VC.
Before Optum Ventures, Vijay was a life science partner with Catapult’s GM&C Life Sciences Fund leading and managing investments across life sciences with a specialist focus on digital health. Vijay has invested in data driven companies targeting respiratory health, complications of diabetes, patient safety, consent and education.
Prior to this, he was chief investment officer at a health care IP commercialisation company focused on digital health, diagnostics and therapeutics investments. He was previously a health care investment banker at Peel Hunt and Piper Jaffray, looking after listed health care clients as well as undertaking IPO, M&A, private placement and secondary fundraising transactions.
Vijay began his career in medicine and worked as a doctor for the NHS. He qualified from Guy’s Kings and St. Thomas Medical School in London and holds a MBBS in Medicine and a B.S. in Development Neurobiology.
Vijay offers a unique perspective as Optum's only medical doctor turned investment banker and VC.
Before Optum Ventures, Vijay was a life science partner with Catapult’s GM&C Life Sciences Fund leading and managing investments across life sciences with a specialist focus on digital health. Vijay has invested in data driven companies targeting respiratory health, complications of diabetes, patient safety, consent and education.
Prior to this, he was chief investment officer at a health care IP commercialisation company focused on digital health, diagnostics and therapeutics investments. He was previously a health care investment banker at Peel Hunt and Piper Jaffray, looking after listed health care clients as well as undertaking IPO, M&A, private placement and secondary fundraising transactions.
Vijay began his career in medicine and worked as a doctor for the NHS. He qualified from Guy’s Kings and St. Thomas Medical School in London and holds a MBBS in Medicine and a B.S. in Development Neurobiology.
Transcription
Mano Iyer 0:06
Thank you very much. All right. Wonderful to be here. It's such a talented and distinguished group of investors, perhaps best to start on the far end with Murielle, if you wouldn't mind, introduce yourself and your, great, thank you.
Murielle Thinard McLane 0:18
Thanks, Mano. Murielle Thinard McLane, I'm a director at Intuitive Ventures. So we're the strategic venture capital arm of intuitive and we invest in series A and B, we have $100 million asset under management, a Series A and B in medtech, broadly, digital health and diagnostic, really looking at expanding the ecosystem of minimally invasive care. I'm actually an operator and an entrepreneur by background so I've been in your seat.
Janke Dittmer 0:49
Hi there, my name is Janke Dittmer. I'm General Partner at Gilde Healthcare lead the European Health Tech activities. So that's medtech, digital health, diagnostics, and life science tools. We are transatlantic venture and growth capital fund with two and a half billion under management. We just raised our six fund close to 700 million euros. And I think you know, being transatlantic is very close to our heart as our investment thesis we have an office in in Boston and representatives across the US. In Health Tech, we invest about one half of our funds in the US and the rest in Europe. I'm originally a scientists turned entrepreneur turned corporate venture capitalist, a bit of consulting in between now for for 12 years been doing this. And as you will find out to have some history actually with some of the people on the panel here.
Sasha Berger 1:49
Well. Good afternoon. My name is Sasha, I'm a general partner TVM. TVM Capital is a fund with with a long history. We also in this business for 40 years. Right now we're investing out of half a billion dollar fund with a transatlantic team. So team members in North America and in Europe, I personally based in Munich, and we're investing a significant portion of that capital into devices, and other late stage opportunities and diagnostics and digital health. Typically 10 to 20 million would be our preferred ticket size. And my background is in chemistry, and finance. And I've spent 10 years in different industry roles before joining TVM seven years ago.
Mano Iyer 2:44
Thank you Sasha. I'm an American has been bouncing around Europe for a long time. So not sure where home is anymore physically based just out of Amsterdam right now. With Sofinnova. So we're 50 year old venture capital firm but 500 companies invested since 1972. 2.5 billion Euros assets under management right now. 100 active portfolio companies, six different funds from early stage medtech to late stage life sciences, including industrial biotech and a new exciting digital medicine fund, my partner Simon Turner's on a couple of panels here. So exciting new opportunities there, I think is everyone's looking at digital these days. So want to make this useful for everyone. I'm an entrepreneur at heart. So most of my career doing that, and want to build off of the friends on the previous panel to expand the scope from from Europe, to the US as well. And maybe the caveat here is obviously we know that neither the Europe nor the US are homogeneous from a cultural standpoint, personality standpoint, or healthcare delivery model standpoint. But let us proceed to grossly oversimplify things, just from a show of hands from an audience standpoint, who's who's raising money right now? It's anyone raising money? Alright, half the audience is in denial because you're actually always raising money. You just don't know. How many folks are in Europe, from Europe and keep your hands up. How many people are having a hard time raising money and okay, well just want to get a sense of things. Just from my entrance to lunch about an hour ago, I bumped into four different I think entrepreneurs and I got the full range of the markets not so bad. The markets, okay, the markets harsh, and I'm not sure what the market is right now. So we'd love to ask all of you your perspective, obviously, we came out of 10 12 13 years of exciting growth, you know, had easy money, SPACS, you know, the world was going really well up until 2021. We ran into a wall of, you know, inflation, insolvent, bank insolvency, you know, global political issues and so forth. But you just announced your funds, we're all actively investing out of funds. So what's what's the state of investing in your perspective and medtech and Murielle you might have You're you're with intuitive it's a, it's an internal fun, but maybe we can talk a bit about your perspective, you're being the only one in the US at the moment.
Yeah. So for us, I would say we shouldn't say we love it. But it's actually as a Strategic Fund, we tend to be more conservative, maybe that's some of the froth that we've seen in the last few years. So this has been a great time, we've been very active. And so we continue to invest and see a lot of really, really good deals. So we'd say, there is money. Most of our portfolio, we have nine portfolio companies right now, five of them raised this year, we've seen them having no problem raising, even at better evaluation unexpected. So money is there, it's really about presenting differentiated ideas to people like us. And I would say, as a strategic being in a more rational timeframe, from an investor standpoint, is really helpful. And you'll see, we're working with a lot of active people, such as people on the panel, and as long as you're presenting correctly, your idea, you'll you'll you'll find interest, it may take a little longer. Rounds are closing taking, we're taking a little more time and due diligence. But the rational money is here and here to stay.
Janke, you've done a wonderful job raising funds difficult times easier times. Now, again, COVID. And this year, you guys have done an amazing job raising funds. What's your perspective? Now you've I mean, you've invested in early, late US/EU things change for you.
Janke Dittmer 6:36
I think raising, raising a fund is always difficult, right? That's for sure. But if I compare the four fundraising that I've I've done in 2009, and 2015 16, and then 2020. And today, clearly, the 2009-11 was the hardest. Even though we already this was our third fund, we had a long history as an institution at the time. I think the 2016, one was the second hardest. And it turned out to be very good vintage. The 2020 race was the easiest by far. I think for the first time doing it all by zoom, we were done in three months, you know, raising over 400 million. And this time, I think it became harder again, but I think there's still money out there. So that's on the, on the fun side. For the for the companies, I think we are in a very unique situation where there's entrapreneurs out there that actually don't really remember the the old times good or bad, but the normal times. And if if I kind of just cut out the 6 trillion that were injected into the US economy between 2020 and 22. And look at the effect of that, which could no go nowhere, except for a few sectors, including health care. If you take that anomaly out, we're sort of back to sort of the old normal. So we're back on top of the good times of pre pre COVID. But it's not treating every sub sector equally. I think that's really important. And even within medtech, which is what this conference is all about. I think it's become a lot more selective. I think in 2021 2020, we saw a lot of companies get get financed. And now I think the really good companies are still finding it not too difficult, it's competitive. But if you have difficulties in your your your business model, you don't have reimbursement lined up, you know, it's it's it's really challenging, then the fundraising has become much more challenging for those companies
Mano Iyer 9:04
Just covered the rest of the panel, new topics, but we'll come back to that. Such what's your perspective here?
Sasha Berger 9:09
Actually, I think that's, that's totally awesome. My perspective, the markets are more rational maybe these days to to the common as Janke said. Before I think there were a few years of irrational markets. So everyone was was chasing deals, it was extremely competitive valuations were not necessarily based by fundamentals. So we had a challenging time also investing because we were we're not moving with the flow, so to say so, for us. Getting back to let's say more normal markets actually is a is easier now. discussing with founders next steps being and rational about spendings. How to how to invest cash rich and all those elements, which were basically not a point for discussion two years ago, because the next IPO was just half a year away. So I don't think it's a bad time today. But I fully agree with Janke, it's become more selective. So those companies who are fulfilling a lot of these typical criteria will will find investors, it may take a bit longer, but they will find them. And for those companies, which were maybe more, more ambitious more, and have not standard business plans and elements, which which are certainly more risky. That that's, that's more challenging to find a broader set of investors these days.
Mano Iyer 10:57
So you've all touched on, obviously, the entrepreneurs from some standpoint, we can dive into that a little bit. I mean, from a and of course, building on the previous panel, you know, the cultural differences here. I mean, we're so to juxtapose EU versus us. And I mean, there's imagine some some elements of valuation here. Right? And the discussions you're having, and what you find is an attractive investment to make. And do you feel like there are differences you've experienced in as you talk to founder CEOs of these companies? And is that part of the challenge from from a valuation standpoint, or other cultural differences? Do you think that you found have come up in these discussions more recently, that may be different from from before, or characteristics of these conversations, I don't know if Yanke, I'll go back to you,
Janke Dittmer 11:41
I'm happy to start be a little bit provocative. We have the story that, you know, when we have companies pitch should at our office, and this European entrapreneur, you come out with, you know, totally drained of energy, and you think like, oh well, it's going to be really hard for these guys. And then someone, you know, in the maybe the associate in the room and sing but you know, that IP that they have, I think that could be really key. And somebody else will say well, but the clinical data, I think they were really smart about how they set up their RCT. And I think they're gonna get there and then think, well, it's actually not so bad. Let's have another look at it. And then you got the American company are present, and we're going out fully energized. Wow, super, super presentation really impressive. And then you walk out to the meeting. And then again, the same associate said, but did you look at the IP, right? And you know, what about that reimbursement code, there is a code, but no, you have to toggle and it's never going to work, right. And the whole thing sort of starts crumbling down. So I think sometimes it would be good to have sort of more of that sort of optimistic spirit on the European presentations, entrapreneurs being more daring, you know, more aggressive in their growth plans. And, you know, inject sometimes a little bit more realism in the the sort of slick presentations we see from the US. That's the stereotype, it is surprisingly true still, although especially in digital health, which we also invest in, we see that there is a new generation of super international leaders that are much less distinguishable. But entrapreneurs, in medtech are much more mature. And that this distinction is still very, very much alive.
Mano Iyer 13:34
I mean, when the challenges here from traditional medtech digital health, if you will, is the experience of the team, right? I think there has been there's been a dearth of that really senior executive talent in Europe for a long time. I think that's changing. It's improving in different pockets around Europe. Of course, we have the pockets, you know, in the US, I mean, Murielle, what are you seeing, as you invest? You know, from from a US based fund here, how do you think about, you know, as you invest in teams in US versus in Europe, and how do you kind of compare contrast the experience that you're seeing?
So medtech, digital different. I would say, first of all, so I'll echo what Vijay said. So the in the digital health ecosystem, it tends to be very young CEOs that are in Europe and want to conquer the world or conquer pan Europe. And they're usually we have discussions of what that may mean over time, and that they may not be the CEO forever. And that's a really important part of our evaluation criteria is seeing who can take the company to where and how willing are they to work with us to kind of get to the next expansion. On the medtech side. In Europe, there's there's an ecosystem that's been here for a long time on the technical side. And the question then becomes how do you augment that to go to the US so it's not sufficient to just have one employee in the US they're just a commercial, and it's not how success has been built? So again, lots of discussion of how they thinking about the US and for us, it's about how the team can grow to the US market. And how can we help them think about it, particularly around, you know, regulatory, which the panel refuse panel was talking about, and then also from KOL, and sort of go to market deployment.
I mean, from an entrepreneur standpoint, maybe I can bring up my own experience here, which actually had with Janke, Gilde, about four or five years in, we received a term sheet or we had a framework for a term sheet in place. And, you know, when I started the company, I had an honest conversation with Antoine at Sofinnova, saying, well, at some point, I may not be the right person to run this company. That's okay. And then over the course of the next few years, you have many near death experiences, and you're humbled in many ways, and, and what what was left of my ego was further trampled upon when you know, Gilde said, Well, you know, we'll invest in record, but I think we need to find a better CEO or a better wasn't the right word, I think, you know, someone with more experience, which I think was appropriate, and it was absolutely fair, right, and looking ahead, and what was needed for the company was someone who had that commercial experience and looking ahead to raise a lot of money likely in the public markets. But when it actually hits you in the face, it's it's a different situation than when you're trying to think about it and plan for it upfront. So I'm curious I mean, conversations you've had I know Murielle, you came in actually, you brought in as someone with with operating experience, right to replace the existing CEO? So are you having these conversations with your with your, you know, potential investments or investments and with with founders, or CEOs who you think may need to be replaced in the future, and it's a very sensitive topic and a challenging one out Sacha, you face this?
Sasha Berger 16:32
Of course, I think every investors face that. And as you say, it's a very sensitive topic, for obvious reasons. So what we try to do is have an open conversation before we invest, because I mean, that's part of the thesis. So to say that we we also well review the the management team and the capabilities and then see what from our perspective would be a good way forward. And at these tests, at that point, the willingness of people to either step back or step aside, it must not necessarily be that that you leave the company, right, but maybe that you just step aside, and you bring on board somebody else who can, who can take on the company for the next the next development phase and bring it to the next value inflection points. And that works good or are not so good. And that's also an indicator whether we want to invest or not. So if that is already complicated, when you talk about it, then most likely will not be easy if you're in the company, so that most likely we will rather shy away from it. But maybe just from going back to that European versus US perspective, sometimes there's that's the great idea to to have a European company entering the US market. And as I said before, you need people on the ground and the US so maybe hire a US CEO for that type of operation. That can be very good. We had examples in the past where it actually worked extremely well. But it's it's also challenging them from an intra company cultural perspective, right, having someone who's maybe brought in was a bit detached sitting in the US trying to move that company to become more us focused is not an easy task. So on paper that sounds great, because it does everything right it's it's the the European r&d and basics and the US capital markets focused CEO but that's too often just the dream to be honest, then then reality to make that happens. So
Mano Iyer 18:56
Janke, have you have you experienced it as you've I mean, you've built a scaled companies from Europe to the US. I mean, what's been what's your perspective here?
Janke Dittmer 19:04
There's no formula for making it happen. I think the old adage, if you want to really understand the market, you need to immerse yourself and it's still true. So I've admired founders who have basically packed their bags and said, Okay, I need to go to the CEO. I'm actually going to move there. And by and large. I mean, they, they did pretty well in doing so and learning. The other part is like the the sort of courageous conversations that need to go on at the board level and in a one on ones with the founders before you invest while you invest. I think we've come out of a period that was very founder friendly, where I think some investors have shied away from those conversations. And it's not always easy in the best interests of the company and the founder, actually, themselves. So I think this is something that for the entrepreneurs in the room, it's important to look out for that you don't have someone who just agrees with you, but you know, basically brings, you know, in that situation sort of truth to power, you know, that's really important that somebody is authentic tells you something that you may not want to hear at that point in time. But then you find a solution together, whether it's via, you know, coaching, or support, you know, like, sometimes you have a really good CEO, but he can't take the company all the way, well, then you put in an executive chairman, and you put in a COO next to them, who've done it before. And together, the three of them can actually make it or you basically have a Chief Commercial Officer, who kind of becomes the external face of the company and more of COO who's the internal face of the company. So all of those creative options are possible. What I've seen in the last few years, though, is that there's increasing maturity of the entrepreneurs in Europe, where they actually realize that maybe they're not the right kind of profile to scale up the company, and they come to that conclusion, because they're large shareholder, they want to be successful, they want the company to be successful. And that makes the transition, you know, much more collaborative. You know, ultimately, as I think there is data showing that 90% of the early stage CEOs will not be the right CEOs for the scale up. And I think just speaking that out is not failure, right? You've taken the company to where it is, today. That's a great achievement. And now it's a different stage, maybe you can stretch yourself, put a lot of the company CEOs and founders that I've worked with actually don't like the scale up phase anymore. So, you know, it's, it's actually very different. So I think that's a very important conversation to have. And, you know, if you have none of those conversations, right now, you need to maybe think about getting other investors into your board.
Mano Iyer 22:11
It's actually really well said, and I have to close the loop on our story. I mean, I think it was the best decision I ever made to step back and find someone who had a lot more experience, I learned a ton from him, Andy Weiss. And we can mentor to me, and I realized, I really love early stage med tech, and then the governance of is critical in building and scaling a company, but maybe that wasn't necessarily for me. So it's difficult in the moment. But I mean, I think having that objectivity as an investor is critical and being able to engage in those difficult conversations, everyone, maybe we can shift to business models, to some degree, it feels like, and you've touched on a little bit with regards to, you know, there's there's a lot more money now in Europe, you know, through grants and other aspects and just venture capital funds investing, of course, during the intro, they mentioned a lot more money is being raised in the United States. But from a traditional, say, medical device, therapeutic standpoint, you know, the model is to go do your first in human study in the East, East east part of Europe, at least the countries that are open, and then go to the US because the US is open, it's you know, it's a centralized market. It's FDA is very friendly. And MDR is great and messy. And then if you get through that process and gets CE marked, you still need to navigate, you know, country by country reimbursement, right. So Europe is not homogenous anymore. I mean, is that is that the model? I mean, what's the what's the counter view? What's the what's a better model? What are you seeing as you as you look for investments in these areas?
Yeah, so we're seeing a lot of that model those days, frankly, and the one of the thing that we've seen though, is a lot of European companies think they can take their first in human from US, from sorry, Eastern Europe, and then bring it to the US and say, Hey, we can use some of that, and in reality, no, it's it's early signal, but then you need to replicate everything back. So there's still you know, sort of that that hurdle or that education that we're seeing. But by and large, for us, we're seeing a lot of companies that are bypassing Europe and going directly to US. And frankly, because of where we are also, US market is one that we look very, that we'll look up, it's how that company will scale in the US. And reimbursement is an interesting one, because people tend to think, well, the US is one market, right? It's not, far from that. And you can go at it different ways, depending on where you're selling to Health System, IDN or you're selling to so at risk system, are you selling to Medicare, or is it going to be a private payer? So there's a lot of education that needs to happen as well as our as the companies are going to tell us that they may think about how they position themselves, both on the digital frankly, on the medtech side.
Janke, you have experienced you're also right in terms of these traditions kind of medtech therapeutic business models, which what's your experience up until now? And how are you concerned? From a valuation standpoint? You know, how do you how do you think about investing? For at what stage? That? What are the clear? What are the clear milestones, if you will? And I don't know, what's the role of strategics? If you want to kind of throw that into the mix here?
Janke Dittmer 25:17
Yeah, I mean, it's a big question. But I think over time, you see a back and forth here. So when, when I entered the VC world, the FDA was really difficult. And, you know, everyone tried to avoid the FDA as long as possible, and, you know, try to maybe be can be acquired on based on European approval, European revenue. And actually, a lot of medtech investors when we went back into health tech and medtech actually exited the space, because they felt like this is this is impossible. So that's not so long ago, right? We're talking 15 years. And, and now it's, we're in a different phase where, through, you know, all sorts of questionable reasons, you know, you can't fight fraud with with regulation, in my view, but you know, we are and ending up with a bunch of rules in Europe that are almost as tough as the US in some ways, maybe even tougher, and then a lot of execution challenges that hopefully are transitory in nature, that we don't have enough notified bodies. And there's less predictability right now in terms of the pathway length in Europe, then they use their there ever used to be in the US, right, even in the worst times. So we've come to a point where recently, we had a company proposed to us that they would go to Europe first. And they got a lot of pushback, right, you know, so what's the investment case around it? It's really sad. As a European citizen, I feel like you know, we're letting down patients all over Europe, because they're not going to have the newest and the latest devices in five years time. This cannot remain like that. It's just we have to do something. I'm convinced that we'll find a way to make the pendulum swing, swing back. But for now, right, it's really difficult, I cannot advise a company to go into this sort of uncertain adventure in Europe, when the market is bigger and more straightforward. And there's an EFS and there is a breakthrough designation, and all sorts of accelerated paths to go to the to the US. I think at one point, I think the strategics will come in. And then I hope that will happen soon, where they say, well, most medical device technologies will not be profitable only on the basis of either the US or Europe alone. We need to be transatlantic. And I think that thinking will will, will come back. And if you haven't done anything on MDR, for for last five years comes the time of acquisition. Today, they don't argue that way. But I think in the future, there will come a point where they say, well, you haven't done your homework, we're going to basically pay less. So we cannot forget about Europe. And I would urge people to to keep it at the back of their mind. But it's it's a temporary crisis that we're in right now.
Mano Iyer 28:25
Do you find it other that there's so much money now that is being invested in Europe, and countries are giving so much money in grants, but there doesn't seem to be tracing of where that money is spent? Because ultimately, if everything is going to the US then it isn't benefiting European citizens? Right. And there seems to be a disconnect between the folks who are making those grant decisions and and ultimately seeing where, you know, accountability for where the money spent. But I mean, you think it's temporary accounts reviewed with regards to MDR? Does anyone see clarity on the horizon with regards to what's happening from a regulatory standpoint? Optimism folks. Well, but there's also an element there younger that you touched on with regards to what therapies are you actually creating, right? And how does that get implemented in different healthcare systems, and that's where it can also be country, by country and even within the United States is different. I think from a traditional, you know, medtech therapeutic standpoint, maybe it's clear diagnostics can be challenging digital health. I don't know if there is an established model yet. I heard I think Scott Huenneskens is I think he's in the, in the audience. I think he had a really nice quote, on podcast recently. He's saying, you know, one of the major frictions in his career was the challenge of making good choices versus economic choices, right, Scott? I hope I got that right. of you know, just because you have a you have a good therapy doesn't mean it's economically viable for the hospital and I think it took 20 years for volcano to to get adopted. And so there's also that do you have that assessment in your mind? In your investment thesis when you're kind of looking at these models, you know, from from a traditional metrics standpoint or digital health standpoint, you know, how do you think about it? Since digital health is still still new, right, you've got, you're lacking on the IP side up front. And on the back end, you don't have the exits, you don't have the clinical validation yet. Do you want to tackle the medtech side?
Janke Dittmer 30:19
I'm happy to do that, although also covered digital, of course. But, you know, I think 10 years ago, most people talked about regulation, and how to get FDA approval. And there was very little attention to market access reimbursement, especially in the early phase, I think has completely changed. It's almost like the first question, the second question that comes up in a presentation nowadays is like, how does that fit into the current reimbursement landscape? How does the business model work? How the incentives aligned, and I think it's, it's, it's really good, because we have to be realistic, right, we want to have a profound impact on patients lives, we want to make patients lives better. But if you have a therapy that the system has no way to pay for, it's never going to get to patients. So technologically, may be very effective and very functional. But if you don't have a way to bring it to patients, it's never going to fly. So it's just as important as the clinical data is to do your homework on the reimbursement side. And, of course, you know, it could be that you have to create new codes that you have get new coverage, new new payment models. But you know, you better start early, because those things really take a long time, you better build them into your clinical trial design that you have a healthcare economic studies that have alongside it. And it may be even satisfies both US payers, not just you know, CMS and private, but also European payers requirements, so that you don't have to do everything sequentially. And I think they are we've made a lot of strides forward, the industry as a whole, and investors have become a lot less naive about, you know, how to get paid.
Mano Iyer 32:05
So I think you just spoke to, you know, the need for a lot of money. Right. So maybe bring this back in last couple of minutes. We have back to back to the beginning with regards to the need for large amounts of capital. And I think, obviously, there's major headwind now with regards to, you know, US markets being challenged. I mean, there have been some some IPOs, think recent SPAC, so money has been raised in Europe. I think I know that we had discussion preparing for this with regards to what the the European public market system should be like. And I think there's there's there's different views here. I mean, so should you want to comment, I mean, with regards to your views on public markets, that the availability of an IPO market and really being able to build and scale companies here in Europe, I think you've got, of course, the large strategics in the United States for a long time now. And you haven't had that presence here in Europe. But don't we want that? Do we need that for the long term viability of of our, you know, of our medtech ecosystem?
Sasha Berger 33:06
Yes, we do. But I'm the same as Yanke said, I think we, we all have to be realistic and opportunistic, and work with the environment we're we're working in right now. So yes, I mean, there's there's, there needs to be things done. And there are activities ongoing with the respective regulatory bodies. But I mean, we have to work with the environment we're in. And so I think the best advice is to take the chances which are there and not complain about what could be right? If If so, that's not very entrepreneurial, so yeah.
Mano Iyer 33:45
To create the future, right isn't our job to create the future and create the environment that we need? So I don't know, other views on?
Janke Dittmer 33:52
So I think we need to definitely upgrade the European capital markets. There is some nice beginnings with Euronext, NASDAQ Nordic and but it's not enough, and we're not competitive with the US there. And it's a real disadvantage in the good times that we've had. But even in the in the in the bad times. At the same time, I think it's not so bleak. No arm has shown there is actually an open IPO market right now. If you think big, if you get companies to scale scale that is predictable. You can go public even today. Whether it's a good idea to be public company, that's another question, but you can actually raise a lot of money there. In the US, I think in Europe, we need to really improve things to compete.
Mano Iyer 34:40
Great, thank you. I think we're wrapping up. I think the panel is open for questions. We might hang out after this. If anyone has questions. Any final advice for folks in the audience?
Murielle Thinard McLane 34:50
I'll go back to what Yanke was saying around incentives and alignment. I think that's really, really important, at least in the US to understand it and it's not straightforward being in digital If you're selling to employers are at risk, they have insurers have lives for two and a half years. Something to keep in mind when you're designing your product. When you sell into hospitals, how are you going to use like for the OR how much are you going to create some profitability and in addition to reimbursement so I think as you're looking at US investors, that's one of the first question. We'll look at IP behind. We'll look at the regulatory environment, of course, but how do you align incentives across the ecosystem is really important.
Mano Iyer 35:32
Great point. Thank you. Stay Hungry. Stay Foolish. Thanks, everyone. Enjoy the show enjoyed Barcelona. Thank you, everyone.
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