NewAmsterdam Pharma Company CMD 2026
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Good morning, everybody. Thank you for joining us today for our Annual Investor Day. I'm pleased to have Michael Davidson, our CEO, John Kastelein, our Chief Scientific Officer, and BJ Jones, our Chief Commercial Officer, here with us today speaking, along with many members of our team. Ian Somaiya will also be available for questions afterwards for the presentation. Before we get started, the fun part, we will be making forward-looking statements today. I would advise everyone to please read our forward-looking statement page, either here in the room or also available online at this time. As we mentioned, today, we'll have Michael going through a general corporate update and introduction. We'll have John presenting the science. We'll go back to Michael for an update on PREVAIL, as well as some of the updates on AD, and then BJ will be going through commercial.
At this time, I'd like to have Michael come up and join us.
Michael? Thank you, Matt, and thanks everyone for being here.
We're very excited to share with you our science and corporate update. For us, this is our third Investor Day, Science Day, and for John and I, it's one of our favorite days of the year. We get a chance to talk to you about what we're doing at New Amsterdam, all our achievements. Of course, for us, the most exciting thing about the company is developing new science, helping patients. We really want to share with you all our insights and where we are and look forward to your comments and questions afterwards. We have a new mission statement that I'd like to review with you.
Our mission is to hold a new standard of care for people living with cardiometabolic disease by challenging connections with courage, transferring deep biologic insights into meaningful patient impact, and delivering with rigor, precision, and purpose. This is how New Amsterdam built to go beyond. We have thought about all this, each word, and what it means for us. Of course, we always believe in our other motto, which is expect more. We believe obicetrapib is the type of drug that you can expect more when it comes to delivering better patient outcomes and improvements across multiple disease modalities. I'd like to start, as all of you know, I still see patients four days a month at University of Chicago. I run the lipid clinic. This is a patient of mine, Frank, who's been with me for almost 40 years.
I bring this up because when Frank came to see me for the first time at age 36, he had super high cholesterol, LDL. He had diabetes, very bad family history. I just saw him in the clinic a week ago, and he looks great. 76. He's lost a lot of weight. His diabetes is pretty much gone. He's got a very low LDL and no evidence of clinical cardiovascular disease. This to me is the inspiration that drives me, and I think in many ways helps me encourage all our great advancements we have in New Amsterdam and motivates us to make sure that we can deliver better medicines to make a difference in people's lives. So let's talk about the New Amsterdam value proposition. We have good clinical expertise. That's been our background. John and I have been in this field for 40 plus years.
I think, as you'll hope to see in our discussion today, we designed our clinical development program to maximize success, especially PREVAIL. A lot of learnings have gone into how we went about designing PREVAIL and the modifications we made in the PREVAIL trial. Most important of all is the success of PREVAIL and how that will build value for both New Amsterdam and for patients. Obicetrapib, of course, we're blessed with a great drug. This drug not only lowers LDL, but has multiple effects on many different biomarkers of cardiovascular risk. Of course, we're very excited about the new data on Alzheimer's prevention that we believe is going to be a hallmark of this drug going forward. Now, the unmet need is something that we focus on all the time.
Like I said, I still see patients, and if you read JAMA this week, they have a great article about the global impact of high LDL, and 6 million lives lost, 90 million morbidity events every year due to high LDL. If you look at the maps, the U.S. population, the LDL levels have basically flatlined. They have not changed in more than 20 years. The mortality rates haven't changed. If not, they're going up. We're all excited about all these new therapies, GLP-1s and so forth, but we all know that based on the data, heart attack rates are the same or climbing. Stent PCI rates are climbing. So heart disease continues to be the leading cause of death, and LDL levels that are elevated is the main contributor to that.
I'm excited to have BJ share with you the great additions to the team that we've had in the last few months of remarkable people, some of them here today. We appreciate if you have a chance to meet them and hear about their backgrounds, because it is a phenomenal team that we're developing across the company. Now, KOL support continues to build. We've had MSLs in the field for more than two years now, and the feedback we're getting from the KOL community is really very encouraging and inspires us to keep going and to prove the benefits of obicetrapib across the disease spectrum. Our CMC team, we don't talk about this too often, but it's a phenomenal team. They just won the Green Chemistry Challenge Award, which is like the Nobel Prize of manufacturing.
We're very proud of that team and all they've accomplished. I think the most important thing for the value creation is they develop a very robust supply chain for obicetrapib and the fixed-dose combination in preparing us for launch in Europe and across the world. The final point, again, is where we are moving forward as a company, and we're really excited to share with you where we're going today and into the next few months. The accomplishments, just to highlight for you the key things across all our data with BROADWAY and BROOKLYN and TANDEM, building out our team and doubling in size. We're now more than 100 people and opening up a new office in Elkins Park of Philadelphia, along with our office in Miami and Amsterdam.
Of course, we've been blessed with securing a large amount of financing on our cash balance of $678 million, which gives us plenty of cash to launch this drug when the time comes. Let me give you a few important kind of key takeaways from the market itself. Again, I have this insight in my own practice of what's going on, and I think we can say that the market is growing. You heard today even from Amgen about the growth, 37% globally, 50% growth in REPATHA in the last year. This is incredible growth in the lipid market. The guidelines have been revised recently to go back to goals, 55 LDL for the very high-risk patients.
That's a huge number of patients that are going to be added to the number of patients that need to be treated to get to the adequate levels to reduce cardiovascular risk. The other important attributes are the FDA guidelines, sorry, the FDA labeling that they're allowing now for lipid drugs is getting broader, and payers are responding to that. We've seen a much more broader access for all the LDL-lowering therapies. Though for us, this represents a market, and BJ will go into more detail later. This is a market that's growing robustly. The guidelines changing. It still hasn't reached the impact it's going to have. New entries in the market is going to grow the market even more.
We feel we're really in a great position with obicetrapib to really do very well, and I'm very confident that the drug will launch exceptionally well across the world. We're excited about our first regulatory recognition from the CHMP, have recommended for approval by the EMA. For John and I, in particular, just focus on John. We've been working on CETP inhibitors for 25 years, and to have the first one approved by a major regulatory body, we think is a huge milestone, and we're very proud of this accomplishment, working with our Menarini partners. Therefore, we're all set to potentially get approved on Europe in the very near future. A very exciting time for us with this regulatory recognition.
Now for the science update, where we're going, and like I said, this is our favorite day of the year for us to get in front of all of you and talk about what NewAmsterdam is developing around the obicetrapib, as well as what other things that we're considering when it comes to how to differentiate this therapy from all other LDL-lowering treatments. Now I'd like to turn it over to John to go through that science. Thanks, everybody. I'll be back.
Here's John. Like the Terminator.
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