BoB@JPM: Brian Hilberdink, Boehringer Ingelheim

On this week's episode of the Business of Biotech, Brian Hilberdink, President of U.S. Human Pharma at Boehringer Ingelheim, returns to the show during the J.P. Morgan Healthcare Conference, and following his departure from LEO Pharma (see episode 164). Brian talks about new opportunities in obesity, the benefits of private ownership in funding early science, Boehringer's deal strategy, using AI to improve commercialization efforts, and the FDA's selection of zongertinib (in patients with HER2-mutant NSCLC) for the Commissioner's National Priority Voucher program.    

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Chapters

• 0:00 Setting The Stage At JPM
• 1:47 LEO Pharma Lessons And Wins
• 5:17 Breaking Into Dermatology Relationships
• 8:58 Why Return To Big Scale At BI
• 12:36 Leading Across Many Disease Areas
• 16:07 Career Move From LEO To BI
• 19:10 Culture: Danish Roots, German Scale
• 23:09 Private Ownership And Long-Range R&D
• 27:56 CKD Awareness And Market Conditioning
• 31:10 Role Scope: Run The U.S. Business
• 34:05 2026 Data And Obesity Strategy
• 38:08 Why Drug Launches Miss And How To Fix
• 42:03 AI Shaping Commercial Decisions

Transcript

Setting The Stage At JPM

Ben Comer 0:03

Welcome back to the Business of Biotech on location at the JP Morgan Healthcare Conference. I'm your host, Ben Comer, Chief Editor at Life Science Leader, and today I'm speaking with Brian Hilberdink, president of U.S. Human Pharma at Boehringer Ingelheim, the world's largest, the world's largest privately held biopharmaceutical company with development programs in cardiorenal metabolic disease, CNS disease, immunology and respiratory diseases, oncology and retinal health. Did I mess any, Brian? I I think you covered it. Okay. Brian is making his second appearance on the business of biotech. He spoke with the show's founding host, Matt Pillar, back in the summer of 2023, and at that time was working to grow LEO Pharma's presence in the United States as the lead of LEO's U.S. operations. I'm looking forward to catching up with Brian today about his time at LEO and jump to Boehringer in February of last year. Uh, what lessons and learnings he brings with him from LEO to Boehringer, his strategy for growing Boehringer's U.S. business, and what issues or market dynamics he's monitoring in the U.S. Thank you so much for coming back on the show, Brian. Yeah, thanks for having me, Ben. I'm excited to do this. Um, Behringer or Boehringer. Do you say it both ways? Think about depending on if you're German and in Germany or in the U.S. I know it's a mouthful. Think burr, like I'm called Boeinger.

Brian Hilberdink 1:34

Buringer. Yeah. Burringer. Okay. Yeah. And I know for years in the industry, people just refer to us as BI. Yeah. But we're really trying to brand, and we're really proud of the history and heritage. So it's burr.

Ben Comer 1:47

I've heard Beringer and Bohringer, but not Berringer. So now I have a third uh pronunciation, and it's that's the right one, it sounds like. So I'll uh I think so. I'll do the best I can. I'll do the best I can. Um, I mentioned your previous role, O'Brien, at Leo Pharma. Um, but before that, you worked for 26 years at Novo Nordisk, a Danish company that has done uh fairly well in recent years with a product called semaglutide. Some folks uh listening may have heard of it. At the time you left, you were vice president of sales uh following a transition of Novo Nordisk's commercial model. You joined LEO, another Danish company, as head of the U.S. and as a member of the global executive team in 2023, I believe. Um picking up perhaps where Matt uh left off, what can you say about your experiences uh at Leo? Um, you probably learned a lot about the dermatology segment, for one thing.

Brian Hilberdink 2:45

I did. Um, Leo Pharma is a focused medical dermatology company and also, interesting enough, a privately held company that goes all the way back to 1908. Not as old as Burger, but an old historic company that actually made insulin on behalf of Novo Nordisk going back to 1923. So all those years at Novo, I knew about the history between Novo and Leo. And Leo was a company that was in need of a boost. Uh, actually, we refer to it as a transformation to really turn the U.S. business into the primary growth driver. It's the single largest pharmaceutical market, particularly in medical dermatology. And that was my mission. And the idea was to try to grow the company ahead of a planned IPO. Fantastic experience, fantastic colleagues, uh, great mission that the company's on. And I'm incredibly proud of the work that we did and Leo continues to do in terms of expanding the portfolio. So going beyond a uh anchor product, which was a biologic for atopic dermatitis, being able to add a uh first in-class uh pen jack inhibitor that's been made into a topical, the first jack for medical dermatology without a box warning for chronic hand eczema. Because I think his site had one of those too, but it has a black box warning. It does have a box warning and it's also not indicated for chronic hand eczema. So I think the fact that uh, you know, this is a unique area and a disease that impacts as many as 10% of people, I mean, uh it can be so debilitating that effectively you can't use your hands. So Leo being able to come forward to the marketplace with a treatment for that really provides new hope. And then also recently, they added a Boehringer Ingelheim product actually to their portfolio for a disease called generalized postular psoriasis. Even though it has psoriasis in the name, it's a horribly debilitating disease that can actually uh be fatal. It's an ultra-rare disease. And uh Boehringer, uh, which is you're gonna hear about is an innovation powerhouse in terms of just being able to develop molecules across multiple disease states, like you already commented on, made the determination that it would be in the better hands of a focused medical dermatology company like Leo than it would be for Boehringer to continue to market it alone. So kind of an interesting shared history for me. Yeah um, you know, kind of being on both sides of that transaction, but ultimately uh super happy now to be at uh Boehringer Ingelheim.

Ben Comer 5:17

Uh, what is different about uh commercialization in the dermatology space versus maybe some other therapeutic areas, would you say?

Brian Hilberdink 5:25

I think dermatologists are very interesting people. Nobody uh accidentally becomes a dermatologist, right? They were all number one in their um medical schools and made the decision to be in dermatology. Um I think dermatology, it is a very much you'll hear from every single derm, it's very much relationship driven. And I felt very much when I was at Leo, I had to very much be the, you know, kind of face of the company. I go to a lot of different derm conferences and get to know a lot of the dermatologists and just understand, you know, what their various business models were and how we could best partner with them so they could make effective clinical decisions.

Ben Comer 6:04

How did you approach that? Because I assume you probably didn't work with a lot of dermatologists previously prior to joining Leo. I mean, are you are you just uh a really good at small talk? I know I'm not, uh, but I'm just wondering how you kind of break into that segment if, you know, they didn't know you before that.

Brian Hilberdink 6:23

Lots of really talented people at that company who broke our introductions. But it also means that I accumulated a lot of air miles and uh went to a lot of conferences. And I did go to a lot of meetings. And at the end of the day, I started as a sales rep many years ago. And when I run into a stranger and they ask me what I do, I typically say I'm in pharmaceutical sales. Because at the end of the day, I think we're always we're always selling. And in this case, it was, you know, selling the prospect of what Leo Pharma could do. Not too dissimilar. When I'm at Burringer Engelheim, now I'm, you know, kind of selling what this company is all about. And the reason why I'm so excited about this podcast, and the reason why I ultimately went to Burringer is because I'm really happy with the work at Leo. Really great that it's on a growth trajectory. And, you know, it's a company that I hope your followers continue to follow as they continue to do great things and treat patients that wouldn't otherwise be treated with these medical dermatology conditions. But man, there was a tug to get back to big size and scale. When I looked at the pipeline, when I looked at the commitment that Burr Runner makes to research and development, and just looking at that potential, that if we can now line that pipeline and innovation up with just having the right commercial ambition. And again, not saying that anything is broken or dysfunctional on Burr Runner. On the contrary, it's been a very successful company. But I think with all of the launches coming up, there's an opportunity to kind of hit that next gear and to really have people understand that Burr Ringer isn't just innovative from what we do in our labs, but also innovative in our go-to-market approach, also innovative in terms of how we prioritize the patient and put them at the center and make a significant difference. And that to me is super exciting, especially in disease states like obesity and type 2 diabetes, chronic kidney disease, interstitial lung disease, getting back into oncology. I mean, just to mention a few.

Ben Comer 8:16

Yeah. Well, is have you found it difficult to have to um navigate all of those different therapeutic areas? As you said, Burring are, you know, is active in quite a number of therapeutic areas. Now, you're not going to see physicians face to face, I don't think, in your in your new role. But how do you manage that? Uh, just the the fact of so many different uh disease areas with, you know, very different dynamics, different kinds of physicians. Um all of that. Yeah.

Why Return To Big Scale At BI

Brian Hilberdink 8:45

I mean, first off, I do try to meet with I do try to get to conferences. Obviously, I can't hit all of them. Um, you know, I have a clear comfort area in cardiometabolic giving all of those years at Open Nordisk and you know, kind of some some deep knowledge of some of those disease states. But one of the things that I'm really blessed to have at Berringer is some great scientists and just great colleagues and people who do deeply understand the disease state. My job is to make sure that I basically um, you know, get out of their way, help enable them, find out what's going to make you most successful. When we have an innovation in a disease state like interstitial lung disease, I mean, we have a history and heritage in respiratory and pulmonary diseases. I think the question I ask as a leader is what's going to take us to that next threshold? What's going to help you to be able to help providers to help their patients? That's my job, not being an expert on everything there is to know about interstitial lung disease. I'm getting there though. I mean, I do enjoy and getting to know a lot of pulmonologists using that example. But yeah, you have to kind of prioritize. My job is also ultimately enabling everyone at Burringer to be the best version of themselves.

Ben Comer 9:55

So you felt that pull uh while you were at Leo. How did it actually come? And and maybe um through that the product that that went from uh from Burringer to Leo. I mean, was it was there an introduction made there? Um, how how did it actually come to pass that you went from Leo to Burringer?

Brian Hilberdink 10:13

Yeah, the the whole Leo Burr Runner thing was more of a happy coincidence. And okay. I was in the prospect that Leo of basically meeting with everyone who had a dermatology product. I'm super active at meetings like JP Morgan to kind of, you know, speed date with as many companies as possible, find out who has a medical dermatology asset. And Burrunner was a company that we approached, and by the way, just super impressive through all of those interactions. But no, it was just more through my own contacts in the industry, an opportunity came up that their human pharma uh president position came up. And as I started to have conversations with individuals uh within the company, again, just that thought of getting back into obesity cardiorenambolic. I don't want to say mission accomplished at Leo, but there was a great management team with place, a ready-made, great successor for my position. Um, you know, with the full support of the CEO and the chairman of the board of Leo Pharma, consulted with them in terms of, you know, I got this opportunity. Yeah. I kind of made the decision that, you know, listen, I got lots of runway, but I kind of also thought at my um age and stage of career, how many more shots do I get to be able to lead at large size and scale? So um, again, it was very much, you know, through the front door. I still have a ton of respect for Leo. What a great opportunity. And I'm so grateful for that opportunity between Nova Nordisk and Burreimer because it truly meant that I needed to run the entire enterprise. When you are a smaller company, when the company's been losing money and you try to get back into being cash flow positive, which is a situation the company's in now, you need to turn over every stone. You need to understand every aspect of the business. Now, being able to take some of that philosophy and applying it at scale, I think it makes me much better at doing this job now than if I didn't have that experience. Interesting.

Leading Across Many Disease Areas

Ben Comer 12:02

Um, you're Canadian by birth, uh, but you've spent a bulk of your career working um for the US in the US for Danish companies, um, Leo and Novo, obviously. Uh Beringer is a German biopharmaceutical company. Um, and you're getting close to, uh I think you're getting close to your one-year anniversary uh with uh with Buringer. I'm curious to hear what you might say about the cultural differences between your previous Dutch colleagues or excuse me, Danish colleagues and and your new German ones, maybe as it pertains to commercializing drugs, but uh I'll leave it wide open for you.

Brian Hilberdink 12:38

Yeah, I'm gonna I also lived and worked in in Denmark for eight years over two different routines. Oh, okay. So it's a it's a culture and a country that I'm very familiar with. But and interestingly enough, you mentioned Dutch. My last name is Dutch. I'm first generation Canadian. My parents were Dutch immigrants to Canada. So I guess I was made to somehow be in these Nordic-type cultures. The thing about Burr Runner is yes, it is a driving company, but it's actually highly globalized. It's highly national, similar to Nova Nordisk. And also what Leo is trying to do as well, our global leadership team was very diverse. So when I think about the composition of the executive committee, when I think about the board of directors, when I think about the diversity of experience in headquarters in Burr Runner, it's really dealing with a global company as opposed to it really, you know, feeling like a German company. But uh, the one thing that is really consistent about Berrunner, about Leo, about Novan Nordisk, and I never want to be on the wrong side of this equation, it's a patient-centric focus, highly ethical companies, highly research and innovation-based. And that to me, it's it's I've always been the person who, you know, we've all been to dinner parties where somebody wants to bash the innovative pharmaceutical. And I always want to be that person to say, let me explain the company I work for. Yeah. And I can do that, you know, uh, feel really good about representing Burr Runner Ogeheim. And, you know, in the past I've been fortunate enough to work for companies that truly do embrace taking that patient-centric approach. Um but then there is one aspect that's unique about Burringer that does kind of differentiate it. I guess Leo was there because it's privately held, but also though was planning for an IPO, so we acted more like we're publicly traded. Burringer is a privately held company. The largest uh farm in a privately held farm in the market. Right working. Yeah. And as a result of that ownership structure, we can really take a long-range view. The company's been around 140 years, and we talk about how we focus on health for generations. We don't have to stand in front of analysts judging us on a quarterly basis, talking about how the earnings are going. Company's very healthy, by the way, but we can make a decision in terms of the you know, EBIDAL level that we want to run at, the level of investment that we put in research and development, which by the way exceeded 27% last year. At our size of scale, doing 27% plus focus in research and development is almost unprecedented. And we can do that because the idea is that we want to continue to focus on basic discovery. We want to continue to have as many assets as possible in early development. So as we know, there's a lot of attrition. It just means that we have more shots on goal to be able to pull these products through the full development process and ultimately get innovation to patients. And it's a really great sustainable model. And I think that that's something that is very unique about this company and something I'm very proud to represent.

Career Move From LEO To BI

Ben Comer 15:35

That makes a lot of sense. You know, I I've always thought about science, as everyone knows, is an unpredictable uh endeavor. And yet public companies um, you know, have to execute, have to try to hit their projections every single quarter, uh, regardless of what happens uh in a clinical trial that's maybe unexpected or any number of uh of external factors that can impact uh a company's development and commercialization efforts. Um so that that makes sense to being able to take the long view, not being as pressed, you know, to every quarter deliver a certain specific thing. Um, but are there would you say are there any downsides uh to being a and maybe there aren't, I don't know, but are there any downsides to being a private company versus a public one?

Brian Hilberdink 16:22

It's it's yeah, you you you could say if you don't like the culture, it's not going to change. Just because that culture has been ingrained for 140 years. Fortunately, I love the culture and it's a really good fit for me, and I think it's a really good fit, you know, for the more than 50,000 employees that we have globally. Um I I I really do believe that we are set up for the long run. I mean, like I said, we've been around 140 years. There's no intention of the company going public. Um, and and I think maintaining this long-range focus is ultimately something that is is good for patients. I think it's not just even innovation and research and development, it's the approach that we can also take in terms of how we can help to condition markets, how we can help to define disease states. As an example, we're putting a lot of resources behind a campaign on chronic kidney disease. There are more than 35 million Americans that live with elevated microalbenuria. It's something that you can test for with a simple urine test. But when people go for a um standard metabolic panel blood test, it doesn't show up because you need to do a urine test. It costs like 12 bucks to do this test. If you have elevated microalbenuria way before your kidney function starts to decrease as measured through EGFR, it means that you have a high risk of endothelial dysfunction. This is a modifiable risk factor at the same threshold as hypertension or LVL cholesterol. Now, this is an area of interest in us, but we're really committed to banging the drum to you know get the public narrative out there to get tested. We have this campaign that's running on television television now called Detect the SOS. Now, if I was at a publicly traded company and we had a bad quarter of results, you know, knock on what ever happens at Burr Runner, but if let's just say you have to issue a profit warning because your you know earnings are coming in a lot lower, that's where you need to start leveraging the cost base. Doing things like, you know, public awareness campaigns and research and development, those are some of the easy cuts to do. Yeah, right. That easy cut isn't happening at Burr Runner because we're, again, focused on the future. We're focused on the long run. So it continues to be business as usual. So that to me, I think, is really unique and I I just see it as an advantage.

Culture: Danish Roots, German Scale

Ben Comer 18:40

We had the CEO of uh ProKidney um on the show, which is a really interesting company, but uh he he kind of hammered it home to me how really how bad uh kidney failure is, uh, just in the context of dialysis and what it means for patients' lives who, you know, have kidney failure, chronic kidney failure, and uh it it makes it almost impossible to to do most things um when you're having to go into get dialysis multi multiple times a week. Um I wanted to ask about your uh chief responsibilities at Buringer as its US uh head. Um are you involved in things like uh prioritizing clinical programs, or are you are you still now at JP Morgan, you know, talking to everyone looking for potential uh acquisition targets or partners? Um give me a sense of um of your job at Burring. So my job is to run the business.

Brian Hilberdink 19:36

Okay. Um we have a uh innovation unit, which you could say uh runs in parallel with the human pharma business unit. Obviously, I work in close collaboration with them. And we have quite a few representatives here from that innovation unit that are specifically in business development looking for different assets.

Ben Comer 19:53

The innovation unit is globally centered, or is it based in in the US or uh both. Okay.

Brian Hilberdink 19:59

So it is it is Globally centered, but we have a large presence in the U.S. Okay. We do a lot of basic research in Ridgefield, Connecticut, where our US uh campus is a very significant uh footprint. So we have a team here that is uh talking to a lot of different companies trying to find assets, particularly um early development assets, uh, a lot of preclinical. Um our thought process is um, you know, again, let's take that long-range focus. We don't need to be competing downstream for an asset that's completed phase two development and get into a bidding war with other pharma companies. Let's fill up the funnel. Let's get as many assets as possible. Again, let's take as many shots on goal as well. Play some bets. So we can then bring those through the clinical development program, and we can define the clinical development program, which we have a lot of expertise on. Right. And then, you know, with the hope that we're going to get some of them through to the end. I think the recent approvals that we have, those are um both uh uh JASCAD and interstitial lung disease and and uh her nexios, uh non-small cell lung cancer with a HERTI mutation, those are actually both assets discovered at Berberner. In-house. In-house. So, I mean, we do have this really good history of being able to discover, but also a good history of being able to get assets fairly early in development and then defining the clinical development path. But back to what I do on a daily basis, it's really running the business. Okay. It's how do I take, you know, this great innovation that's coming from what we refer to as our innovation unit and define the go-to-market approach, making sure that we're ready to launch products for markets that products that are in the market, are we executing against the things that we said we would do? How do we know we're moving the needle on things like raising awareness and chronic kidney disease? Are we fully prepared for entry with our future obesity drug? Those are more the things that occupy my time.

Ben Comer 21:48

Okay. Um what opportunities or or challenges, Brian, um, do you find most enticing? I guess in the context of your your role at Buringer and thinking about the the company's strategy for 2026?

Private Ownership And Long-Range R&D

Brian Hilberdink 22:03

Um, well, I mean, right now we have uh two products that we've we've just launched. We have one in interstitial lung disease, and we have one in uh, as I mentioned, in non-small cell lung cancer. So I would say it's more of an opportunity than a challenge, but as you know, uh the early uh launch phase really dictates what that lifetime potential of the brand is. So making sure that it's clear of the decks, let's do whatever we can in order to make sure that we can get these products off to a good start. Yeah. And uh knock on wood, but so far, so good. The polynology community and the oncology community is responding very positively so far to the fact that, you know, we do have these new products coming to market. 2026 is also the year that we will be releasing a lot of data from our very robust obesity and liver health program. So we will enter into that anti-obesity mash space in 2027. So making sure that when we do release the data, that again we're we're managing the story and the narratives, you'll hear me say over and over again that I'm not going to be competing against Nova Nortis, Ganela, Lily. I'm gonna compete against clinical inertia. Let's recognize the fact that there's a hundred million Americans living with obesity, and yet there's less than 10% that are getting an evidence-based pharmacological treatment. And I'm not saying that all 100 million need to be treated with pharmacological therapy, but it feels like obesity is at this tipping point. It's like type 2 diabetes 25 years ago. We used to blame the patient for giving themselves type 2 diabetes. Now we know it's a complex metabolic disease. Can we not get there with obesity and stop shaming the patient and also focusing on going way beyond pounds on the scale and talking about metabolic health? So 2026 is going to be the year that we need to start shaping the narrative because Burringer is not knowing yet in the obesity space. If we do this podcast next year at JPM and we're still not knowing, I haven't done my job. Okay.

Ben Comer 23:59

Yeah, I I I saw uh David Rick speak during Eli Lilly's presentation uh at the conference yesterday, and he he mentioned the fact that um for uh folks who are prescribed uh one of Eli Lilly's uh GLP1 drugs for obesity, um, on average they've tried uh at least 30 different dietary and exercise interventions that haven't worked uh for those uh patients. So uh so it's not like something hasn't been tried, you know, um, before they are ultimately given those prescriptions, which I thought was um was interesting. I I also wanted to pick up on something you mentioned about, you know, preparing for a successful launch and driving a successful launch. You know, there's this statistic that's bandied around a lot by executives. I've spoken to um that, you know, 50% uh of drugs, new launch drugs, do not meet um their expectations. Uh why do you think that is? And um, you know, what what can you do to try to increase those odds, you know, of success with a newly launched product?

Brian Hilberdink 25:04

Yeah, I mean, it a lot of it depends on the disease state that you share, right? So if you're talking rare disease, the number one mistake is underestimating or overestimating the epidemiology. So just understanding the prevalence of the disease and the challenge it can be for healthcare professionals to identify a patient who's living with that disease and to get them treated. Okay. Another common area that uh can be a stumbling block is can patients get access to your product? Because we can go through that whole clinical development program. We can develop a beautiful label, we can have great messages, but if patients ultimately don't have access to it in the form of uh insurance coverage or even if it's a cash pay offer as we're seeing more and more. So we need to constantly think about what's that right balance. Of course, we need to recoup the investment that we put into it, but to try to understand what's that right price threshold in order to get reimbursement, but also again, make it a viable, sustainable product. Um, and then last but not least, I mean, just it just good old-fashioned competition and share avoids, particularly if you're going into the primary care space. So who are the big players? Um, what is already, you know, well entrenched in physicians' minds. I mean, it's interesting going back to my experience at Leo Pharma, what a great lesson learned. Because it's one thing to be Novanordisk or Berber Engelheim, where you do have resources. Try competing when you are very much the small company and you're going up against big juggernaut companies that are doing lots of direct-to-consumer advertising and they're outgutting you maybe 20 to one from a sure voice. Have established relationships with LBT Opinion. Exactly. So then you need to kind of figure out, okay, what can I realistically accomplish? What's my go-to-market approach? Which segment can I own? And this is where, like I said, I'm so grateful for that experience because I kind of feel like those lessons learned are actually great lessons to take over to Burranger. So again, as we approach these new markets, just because we have size of scale doesn't mean that we need to follow the same template of every other company. Can we be a little bit smarter? Can we segment the audience differently? Can we find different areas to differentiate the brand? If you're not differentiated, why is someone going to move off of what their current gold standard is? So I mean it sounds like kind of marketing model one, but we forget these lessons. And it's important to remember drugs do not sell themselves. As good as they may be, as important and innovative to help patients, if there isn't the right plan to put around it to pull it through, it's never going to get lifted off the ground.

CKD Awareness And Market Conditioning

Ben Comer 27:33

Yeah. Um access obvious. I'm glad you mentioned that because that's obviously a key aspect of whether a drug is going to make it to a patient or not, regardless of how good it is. Um thinking back to, you know, uh Eli Lilly now, it sounds like Medicare Part D is going to potentially start covering um their GLP one for weight loss. So uh that that'll be interesting to see. Um, but I want to ask you next, uh Brian, a question about AI. Uh it's an inescapable aspect of life in 2020, uh regardless of industry or profession. Uh, what can you say about how AI is changing product promotion, sales, and and marketing, if in fact it is?

Brian Hilberdink 28:15

It it it if it isn't, it should be because it's gone beyond just table stakes. I mean, if you're not embracing AI, you are behind the game. And I I do believe when you think about the ability of the synthesize data, I just talked about different go market, go-to-market approaches. How do you segment? Um, how do you adjust when you are on market? If you think about a launch, if it isn't going according to plan, what adjustments do you make? Being able to have real-time information on different providers, understanding patients' experience, you know, as they're trying to navigate things like reimbursement. These are things with the right AI tools that are in place so you can have real-time access to information, and with that information, be able to adjust the approach you take. So, this is something that we very much embraced at Berliner. We've made a very significant investment in AI. And, you know, it's it's a process. Yeah. Uh, and it it it takes some change management uh because it means changing the way we work and going from developing, you know, pivot tables full of data to understanding how to write a good query. Yeah. Right. And getting curious about questions that I can ask that are now possible to extract that information. So uh we actually built an AI innovation team that is continuing to look at piloting different ideas and you know, either fail fast or scale it up. And we're doing more scale it up than fail fast and learning very quickly in this space.

Ben Comer 29:41

Yeah, that's really interesting. I was curious if if Buringer had a kind of overarching AI strategy or if it was more of a kind of business unit to business unit effort. But it sounds like I think it has to be overarching.

Brian Hilberdink 29:53

Yeah. And uh and that's where it is in a in a centralized function that can help provide uh support to the entire enterprise. Uh and that way too, we can build economies of scale, we can get learning. Of course, we're in an industry that's highly regulated, so we need to make sure that we're doing it with the right compliance boundaries. So uh we are learning as we go, but it's uh it's a worthy experiment, that's for sure. Yeah.

Ben Comer 30:16

And changing day to day. And changing exactly. Um what uh um Beringer uh Beringer, excuse me. Uh uh has been pretty active on the deal front uh in in the last year as head of U.S. Pharma. Uh are you you're definitely involved in that decision-making process, uh, I I would assume. Um yeah, certainly.

Role Scope: Run The U.S. Business

Brian Hilberdink 30:39

Uh, you know, the U.S. is involved in every decision that the company makes from a strategy standpoint. Okay. You know, we have representation directly on the executive team of the company in order to make sure that we always pull through that U.S. perspective. Um, our new chairman and uh CEO as of July, uh Shoshank Despondi, he always talks about the U.S. first mentality and always taking that lens of is this going to work in the U.S.? And therefore, let's get consultation from people that are in the U.S. Also, what's interesting at Burrurger, when you ask what's it like working for the Germans, well, a lot of the people I'm dealing with on the other side are actually Americans. So, you know, our head of our uh cardiometabolic uh therapy area, for example, is uh someone who previously worked in the U.S. Uh the person heading up the obesity brand globally is someone who was actually uh uh you know responsible for the Jardin and Sales Organization as well. Okay. So we're doing a really good cross-pollination of pulling in this US perspective into the global team. So everything we do goes through the same strategic frame. I have to say that's a real strength in the company, is just really good cross-atlantic collaboration.

Ben Comer 31:49

Uh, what kinds of uh deals and partnerships are you interested in now, I guess, um looking forward? Is it, you know, complementary portfolios, uh new therapeutic areas? Can you give me a sense of that?

2026 Data And Obesity Strategy

Brian Hilberdink 32:01

Yeah, I I again I think we start with looking at the therapy areas that we're in. But when you're talking about cardiorenal metabolic, inclusive of obesity and mesh, you're talking in pretty broad space. It's a big space, yeah. Yeah. So I think we can still say that chronic kidney disease, uh, we're developing an asset uh uh in that space. But again, it's not just gonna be one asset that patients are gonna need. We want to be able to provide multiple tools and providers toolbox to be able to ultimately provide um uh good metabolic health. In obesity, I look forward to a day where there's 20 different obesity treatments on the marketplace. Uh again, similar to type 2 diabetes, when you think about the fact that, you know, we once treated patients with metformin and insulin and sulfur and Laureas. Now you look at all the various agents that are being used, including SGLT2s and GOP1s. Well, I think that that's where we're also getting in the obesity space. So we're looking for additional assets, and we have that already in our pipeline, but continue to scale for other obesity assets. Um, interstitial lung disease is ultimately an uh inflammation disease with a lot of carryover into rheumatology. So you could kind of say, how do we now look at adjacencies to interstitial lung disease already working with pulmonologists? But can we start maybe moving into rheumatology as well because of the carryover? That's an audience that is in a good position to be identifying patients with interstitial lung disease. Could we potentially put something else in our reps bag in the future that appeals to that audience? So I think it's constantly thinking about adjacencies to current therapy areas. You did mention another one which I haven't talked about yet, which is something maybe on the other side of 2030, and that's eye health. That's not necessarily an adjacency to anything we have, although you could say we start with retinopathy, there is a strong link to type 2 diabetes. But I think that's what's really cool about Burringer is that we got these fantastic scientists who, quite frankly, shouldn't be caught up with commercial commercialization. They shouldn't be thinking about the go-to-market approach, but they should be thinking about is new pathways, new targets, innovate, come up with something that's new and transformational. Then what the commercial team will determine is is this something that we should take forward? Does it fit into our existing portfolio? Or do we do like what we did with Sky Rizzy, which is actually developed in Ridgefield, Connecticut, and say at that point in time, what do we know about psoriasis and what do we know about some of the other conditions and indications that it treats that someone like Abby is a better partner for it? Um Spavigo was another example that was outlicensed to uh Leo Pharma. I mean, again, developed by Berringer, gave it a gave it a try, but ultimately thought I think it could be in better hands with someone who's focused on that disease state.

Ben Comer 34:51

Um, because it's such a uh a hot area, I want to ask you just a question about obesity. And I'm not familiar, I have to say, with uh with Buringer's um uh obesity candidate, but is the approach in obesity to try to kind of go after uh there's obviously two giants in in the space, uh Nova Nordisk and Eli Lilly. Do you go after a kind of niche uh obesity use, something downstream uh from just kind of simple basic obesity? Uh do you compete on price? You know, how do you think about uh positioning of an obesity product? Yeah, I yeah, so all of the above are considerations, okay?

Brian Hilberdink 35:31

And it has to start off with let's get our clinical data. Uh and as I mentioned before, that we're gonna have a clinical data report out in 2026, and that's largely going to inform where what areas we can best differentiate on. Um unfortunately, there's not a shortage of patients living with obesity that are under treated. No, there's not. And um, you know, I I do feel like again, I I would love to get to a dialogue that we talk about going beyond pounds on the scale and really talking about metabolic health and starting to really redefine what does metabolic health mean. So again, I think uh a conversation for a future podcast, yeah. That's an intriguing one. I would I'm uh happy to come back and talk more about that in the future.

Ben Comer 36:14

Yeah, let's let's do that. Um I want to uh in our last kind of um segment here of this conversation, Brian, I want to ask uh some questions about JP Morgan um and your kind of uh broader outlook. Although I do have one question that's more specific to a Behringer um uh product, but that I'll get to in a second. But for it uh in the context of JP Morgan, for me, the conference kind of helps to set the agenda uh for for the coming year. Um, what's your sense of the mood uh this year at JP Morgan, maybe compared with last year?

Brian Hilberdink 36:49

I would say uh more optimistic. Um I've been at JP Morgan in the past when it's been literally and figuratively ready. Yeah. It's sunny too. It's sunny outside last year. We can walk between meetings and uh not get soaked. But I also feel like that's almost symbolic of uh it does feel like some clouds have lifted. Um, you know, I think that uh companies have found ways to navigate through some of these policy changes. Um, I think from economic indicators, I think that people are feeling a little more bullish. We're hearing about an appetite for IPOs, we're hearing about an appetite for bigger investments. So I think on the whole, uh, I feel like there's there's quite a bit of optimism in the air here at JP Morgan.

Ben Comer 37:33

What are uh some of the key, I guess, remaining uncertainties uh regarding commercialization in the U.S.? What would you say there?

Why Drug Launches Miss And How To Fix

Brian Hilberdink 37:41

Well, I'm I I I made reference to you know some of the policy uh changes that have been navigated. Yes. And, you know, a number of companies, including Burr Runner, have um, you know, agreed to these MFN uh deals. Yeah. Uh it does mean moving more manufacturing into the US, potentially means much more investment into the U.S. But I also think that there's greater certainty now in terms of how to navigate and and move forward. Um, we've heard the administration talk about uh potentially now looking at different ways that the PBMs work. We don't know what that means exactly. But I think what we do know is we've been able to get through this. Um, you know, I won't go into politics, but I think that if you just reflect and say, you know, we have an environment that we can operate in and there's, you know, the potential for much more investment in the United States, it seems like we're moving in a in in in the right direction.

Ben Comer 38:34

Right. Absolutely. Um, that's my sense as well. It's it seems much more optimistic uh this year and and pretty much all of my conversations uh so far while I've been here. Um I I promised to ask you about, or I said I was gonna ask you about a uh a Buringer um product uh that that kind of relates to to this discussion. Um uh Beringer was awarded the FDA commissioner's uh national priority voucher uh for uh zonguritinib? Zogurtinib. Zogurtinib, okay. Um in patients with uh with her two mutant um non-small uh non-small cell lung cancer. Um can you uh uh give me a sense of kind of how that happened or or um, you know, I don't know if uh if you participated in the in those meetings at all, um, but uh give me a sense of you know how that selection was made um and and what it means.

Brian Hilberdink 39:24

I think the agency has um made oncology and a lot of rare diseases a priority. And they've been talking uh for quite a long time about trying to find different expedited ways to be able to get innovative products to patients much faster. And I have to applaud the FDA for um coming up with a short list of candidates, which we didn't partition for. Um, and then we received notification that our drug, so uh Lizokurtnib, also known by the brand name Hernexios, uh, that for an indication for non small cell lung cancer with The HERTI mutation in first line, meaning not previously treated, um, received this commissioner's voucher. And that commissioner's voucher, once you pass screening, is an approval window of one to two months. So pretty much even though, yeah, even though oncology can get approved with phase one data and follow this rolling RTOR process, it probably expedited approval by about six months, which is pretty remarkable because I can tell you by joining Burringer, learning about this disease state, I've also had the opportunity to meet patients that are living with non-small lung cancer uh with a CERT mutation. And we talk internally on okay, well, what could be the size of this product? And, you know, does it ever have blockbuster potential if we move into other tumors or whatever? I'll tell you, for these patients, it is a blockbuster. For these patients, it has the opportunity to be a game changer because it offers it offers hope. And I think anything that we can do to have products that could help provide hope and give clinicians another opportunity, particularly living with cancer. Uh, and if the agency can support getting those products to the marketplace faster, that's a good day.

Ben Comer 41:07

Yeah, absolutely. And um, as you mentioned, the the commissioner's priority review valve or priority review program uh reduces the um the evaluation to one to two months. I think that was announced um, I want to say in November, is that right? So is it any any day now? Like literally, literally any day now, we're expecting to get that approval.

Brian Hilberdink 41:29

So uh it is already on the market for second line. This is the first line indication. And uh yeah, it it literally could come any day now.

Ben Comer 41:38

That's kind of a short runway to get up to speed for the for the launch for that. Uh so you've probably been, I I would assume, pretty busy, you know. The team's busy, but the team is already out there.

AI Shaping Commercial Decisions

Brian Hilberdink 41:47

And second line. The team has already been out there in second line. So again, patients that have been previously treated um have the opportunity to add on her Nexios. Now, of course, uh if we can move it into first line. So it is building on the momentum that's already been established, the relationships that we already have with oncologists. And again, that's where the team and the company made the investment in going out and getting the right team, the right people. They've been out there building relationships. Uh, so we're ready to go.

Ben Comer 42:13

All right. Well, uh final question: your top priorities for JP Morgan uh this year, and maybe uh top priorities for uh for 2026.

Brian Hilberdink 42:22

So, top priority for JP Morgan is really to help get the Burr Ranger name out there. Um, we're a company that uh again is privately held. We're not doing investor meetings, um, but we are here to talk about the fact that this is a special company, this is a different kind of company. And in 2026, we are going to be releasing quite a bit of data in obesity. Um, and we want people to understand that we got a plan behind this. Um, I want to find platforms to talk about things like chronic kidney disease and have people ask, well, what are we doing about it? How can I help? Um, so by creating a platform and getting it out there that you know, Burringer is a very innovative company that's been around a very long time, but we're also going to be known as a commercial powerhouse. The first words I said when I came to Burrow Ringer literally flew to Newark Airport, which apparently is not the best airport if you want to get up to Connecticut, got in the car, uh, got myself up to Bridgefield, got out of the car, made myself to the auditorium. First four words are I love to launch. And that's exactly what I want to do at Burrow Ranger is launch and launch well and be able to bring this innovation to the patients that could benefit from it. And I want the whole world to know that. So JP Morgan is a fantastic platform to get that story out.

Ben Comer 43:44

Fantastic. Well, um, Brian, thank you so much for uh for coming back on the show. I really appreciate it. My pleasure. Anytime, and maybe uh we can we can book that date to share JP. Let's do that. Yeah, let's do that. Awesome. Uh we've been speaking with Brian Hilberdink, president of U.S. Human Pharma at Beringer Engelheim. Beringer, Ingelheim. I'm Ben Comer, and you've just listened to the Business of Biotech. Find us and subscribe anywhere you listen to podcasts, and be sure to check out our weekly video cast of these conversations every Monday under the Business of Biotech tab at life science leader.com. We'll see you next week, and thanks as always for listening.