Good afternoon, everyone, and welcome to the 44th Annual JP Morgan Healthcare Conference here in San Francisco. My name is Alex Kramer, and I'm an Investment Banking Associate on our Healthcare Investment Banking team. It is my pleasure to welcome our next presenting company, Catalyst Pharma. Today's presentation will be given by Rich Daly, President and CEO of the company. Following Rich's prepared remarks, there will be some time for Q&A. We ask that you hold any questions you have until that time. And with that, it is my pleasure to turn the mic over to Rich.
Thank you, Alex. And I just want to say thank you to JP Morgan for the invitation. It's a pleasure to be here with you and to meet the investors and the bankers and the community that's interested in rare diseases. So thank you very much. Obviously, safe harbor statements, I think you're all familiar with that. So who is Catalyst Pharmaceuticals? Catalyst is a commercial-stage biopharmaceutical company focused on rare diseases. And we look to in-license, purchase, and then develop, if necessary, products for the use in rare diseases. We're really proud of our legacy, and we're really proud of how we do business. We're going to spend some time talking about that today. So when we look at the opportunity in rare diseases, really, we have two molecules that we use. One is FIRDAPSE for Lambert-Eaton myasthenic syndrome.
It's the only evidence-based product that's approved for use in Lambert-Eaton myasthenic syndrome, or LEMS. You'll be hearing about LEMS a little bit. And then AGAMREE. AGAMREE is a differentiated steroid for use in Duchenne muscular dystrophy. And some very interesting data has come out of Europe recently, which we're really excited about, which supports our opportunities here and supports the improved care of patients. So we are forging new paths. That's our goal, is to forge new paths to support those individuals living with rare diseases. And we really have a growth-through-patient-first approach. We really look at the approach, how we can best serve the patient. And we'll talk specifically about that, actually, on the next slide. We have bespoke patient programs that ensure that patients not only can get on therapy, stay on therapy, and optimize their dose.
We have a 90% compliance rate with our medicines because of our approach through a specialized pharmacy hub and a third-party logistics provider. We're a recognized partner for value. We do a significant amount of business development. 90% of our acquisitions that we looked at in 2025 were inbound. In other words, people were looking at us saying, "This is a company that performs. This is a company that delivers." We are really proud of that statistic. Since the commercialization of the company, we've had a 37% CAGR. Again, looking at building on that as we go forward. For AGAMREE, which has been on the market since March of 2024, we have a 224% growth of that product through September 30th of 2025. Sorry.
One of the things we're really proud of, and I think causes a little bit of consternation in some of the conversations we have, is we're a profitable company. We're a commercial company in rare, and we're profitable. That's rare. We're really proud of our ability to manage our business really effectively. We have more than $700 million in cash, no funded debt, and we have the ability, as a buy-and-build organization, to spend more than $1 billion in acquisitions. We'll talk specifically about what we're targeting when it comes to the acquisitions or licensing or partnerships. How do we serve the patient community? We look at it as a threefold opportunity. One, we have an industry-leading hub, our patient services hub, best-in-class patient support. Then we also look at a high-touch specialty pharmacy. This is our program called Catalyst Pathways.
When we look at the crossover, the Venn diagram that you see on the screen, it becomes really important. We look at free bridge medication. From the time a patient is diagnosed and enters our system, we give them free bridge medication. If the patient can't get insurance coverage, we guarantee them insurance coverage through appropriate programs by working with our field-based assets that report to the company and working through the pharmacy. We have personalized insurance navigation through the hub and through what I call our patient advocacy liaisons. Then we have broad co-pay programs for those patients who are potentially in government services. We actually direct them through the hub to better services for better insurance coverage, rather. This high-touch specialty pharmacy. I talked before about the 90% retention rate in our patients.
As a pharmacist, as a healthcare practitioner, they can actually reach out to the patient and help the patient appropriately titrate the drug, stay on the drug, and address any questions, and actually work with physicians. And we'll talk specifically about how they do that with the LEMS physicians, the neurologists. Obviously, we have healthcare practitioner education, excuse me, and then direct-to-patient outreach, where we actually will call those patients and ensure that they actually get the prescription they need and then can titrate appropriately. One of the things we're really proud of is our patient advocacy and the patient support that we provide. We have these patient access liaisons that we have in the field that work with patients through permission marketing.
So they actually get permission from the patients, and that helps the patients understand the disease because it's so frustrating for rare patients to actually understand their disease. Typically, for us and our patients, especially on Lambert-Eaton myasthenic syndrome, the diagnostic journey is more than four years, from first symptom to actually understanding their disease and getting on therapy. We have a patient ambassador program. These are patients that are actually on the drugs that we have, and they'll talk peer-to-peer with the patients who are considering it. Again, arm's-length transaction. We stay away from it. The patient's actually free to speak as they deem appropriate. And then we also partner with independent patient advocacy groups to be sure that they have the support that they need to get the information out about our therapies.
So we have a clear and focused acquisition strategy to supplement our organic growth. So we have two arms of it, organic and inorganic. The inorganic growth is the business development that we seek. And so we look at rare disease products across diverse areas. We are therapeutically agnostic and modality agnostic because we believe that the infrastructure that the company has to support the patient and the physician and the provider, I'm sorry, the provider and the caregiver, namely the parent, we think those are applicable to all therapeutic areas. We are looking for immediately accretive or nearly immediately accretive opportunities because we want to continue to build our P&L, build the strength of the company so that we can actually generate more cash to get access to more patients or more products, rather, to help more patients.
We are also expanding our mandate to look at products that are in development. By working with companies that actually have products that are past proof of concept, we can then take a look and see if those products will fit our portfolio. We seek opportunities with a peak sales of up to $500 million. The reason for this is the way we describe it is that once you get above the $500 million threshold, different people show up at the auction, different companies. While we have a really strong balance sheet and a really strong income line, we want to be sure that we are one of the strongest folks at the table when we do, in fact, go for it. We are looking for U.S. and ex-U.S. worldwide rights for our products, the products that we are investigating.
So a little bit more detail, proven business development engine. So we've acquired all of our products, obviously, and developed FIRDAPSE and then had a partner, a licensor, in Santhera for AGAMREE. So we have established infrastructure that is a plug-and-play infrastructure. We can put those products in, get them out of the market, and actually get them to patients rapidly and support those patients. Demonstrated success in launching. I talked about the statistics around AGAMREE. Wonderful launch, tremendous opportunity to improve the care of patients with Duchenne's, but also the sustained growth of FIRDAPSE. We've had 15%-20% growth for almost the entire life of the product. And we all know about decreasing increases over time. You would expect products to slow in their growth. FIRDAPSE, on a bigger base, continues to grow at 15%-20% per quarter. It's astounding.
It mostly is because of the commercial and medical outreach we do in identifying patients. We'll go a little bit deeper into that. As I talked about already, end-to-end patient access programs. We want to make sure the patient has the support they need to make the best decision they can for themselves and along with their healthcare provider. Then adept at extending value. We look at opportunities for extending the value. Typical lifecycle management, looking to build on the success we've had with the products we already have access to. As I mentioned before, financial flexibility. With $700 million, no funded debt, and dropping roughly about $60 million to the bottom line every quarter, we have a lot of flexibility. Very, very strong P&L and a really well-managed company. Excuse me. These are the products that we have. Talked about it.
FIRDAPSE is the only evidence-based treatment for the therapy for the treatment of LEMS, Lambert-Eaton myasthenic syndrome, and we believe that this market has an addressable market in excess of $1 billion, so we're really excited about this one. AGAMREE, equally excited. A newer product for us, as I mentioned. Novel corticosteroid. Again, the addressable market here is $1 billion. The fundamental difference in these two markets is for FIRDAPSE, we are the only player, and there's an opportunity for us to really excel here, and then for AGAMREE, we are one of three players in this market space, but again, we believe we have a different story and a differentiated story to tell. FYCOMPA is for treatment of epilepsy, extended patient preference, driving durable revenue performance following generic entrants.
We had generic entrants come into the space in June of last year, and the performance of the product has been outstanding. Typically, there's a stickiness that's generally associated with epilepsy products. There's another product that went generic a month before us, and we have outperformed that product by two times with generic incursion. So really strong performance. So let's break down our markets. So we'll talk about Lambert-Eaton myasthenic syndrome. It's a debilitating nerve communication issue, nerve muscle communication opportunity for patients to improve. We believe there are between 3,600 and 5,400 patients here. And all of the information I'm going to share with you is at the lower end. We always assume the most conservative base. So we're going to talk about 3,600 patients. 50% of these patients have Lambert-Eaton myasthenic syndrome associated with a cancer, typically small cell lung cancer.
And we have a pool of about 500 patients that we've identified on their diagnostic journey. We do this through market intel, competitive intel, machine learning, and artificial intelligence. And 50% of our patients every month, every quarter, come from that pool of patients. This is a prospecting market. So having to stay out in front of these patients and understand where they're coming, this is what's generating this continuous growth of 15%-20%. So breaking these two markets down, this is really a story of one molecule, two separate markets. And we have equal focus on both markets. Idiopathic LEMS is Lambert-Eaton myasthenic syndrome not associated with cancer. And this is typically treated in a neurologist's office. Estimated prevalence, as we said, 50/50 split between these two, so about 1,800 new diagnoses per year. So this is the potential new diagnoses.
In iLEMS or idiopathic LEMS, it's about 150. In cancer-associated LEMS, it's about 900 per year. The life expectancy of these two populations is quite different. You would expect a cancer patient with small cell lung cancer, a devastating diagnosis, to not live as long. There's interesting opportunities here to actually work through all the oncology practices that are out. We believe the accessible market population is about 80%. Patients who are newly diagnosed might not have significant physical issues and might not demand therapy. Patients who are well advanced in their disease process might be too far along. We're, again, taking a conservative view of this market opportunity. The success we've had so far and the 15%-20% growth with such a small population of patients, really, you're looking at market penetration on iLEMS of only 30%.
There is significant upside here. On the cancer-associated side, we've made tremendous leaps in the last year on our ability to reach this patient population. We expect this to be a real growth driver for us and a value driver. How are we going to attack these markets? Let's talk about idiopathic LEMS for a second. You'll see the same structure here. We have four basic steps that we're trying to accomplish in growing this market and helping patients who are suffering and frustrated, help them get the best therapy they possibly can. We talked about the ongoing patient discovery and looking for those patients and sourcing those patients. We have that opportunity. Myasthenia gravis is number two. It is the number one misdiagnosis for this disease.
And with all of the noise that's going on in the marketplace around FcRns and the direct-to-consumer advertising, we think this is a tremendous opportunity. More patients will be diagnosed with myasthenia gravis and therefore misdiagnosed. And so the next step, we're looking to increase the rates of diagnosis by getting reflex testing done at national labs. So if you come up negative on your myasthenia gravis diagnosis for a blood test, you should automatically get a reflex test for a VGCC test, which helps determine if the patient actually does have LEMS. And so now our focus is on we've checked off the first two boxes. We're focused on box number three, and then growing the awareness of testing throughout the community. So being sure that there is actually reflex testing that is going on. So that's the LEMS portion of our business.
On the cancer-associated LEMS portion of our business, we have a similar structure as well. We got streamlined testing, what Jeff Del Carmen, our Chief Commercial Officer, calls frictionless testing. Previous to our arrangement with a national lab, a patient would, if the physician thought they were going to be diagnosed or wanted them to have a blood test, they would have to go to a distant site, have the blood drawn, come back with the results for the physician. Now we have frictionless testing. The blood is drawn in the office and picked up. This applies actually to both markets, which has really been quite helpful on the idiopathic side. National Comprehensive Cancer Network, or NCCN, updated their guidelines in July to include not only how to diagnose LEMS in a cancer setting, but also that FIRDAPSE is the only evidence-based medicine for the treatment of LEMS.
Boxes one and two are checked off. Now we're working with large, high-control oncology practices to take the NCCN guidelines and translate them into local clinical practice so that they are following their own care pathways in their practices, and then forging a relationship with these practices to do ongoing education as well. We're starting to see a significant uptake here. The testing of VGCC tests, the trend in it, is increasing 9% per month or per quarter, rather, for the last two years. We are gaining traction, and we're really excited about this opportunity. Translating now to Duchenne muscular dystrophy and the AGAMREE, I think everybody here knows the story, rare life-threatening neuromuscular disorder. There are between 11,000 and 13,000 boys, young men who have this disease. 95% of them are typically diagnosed.
Hold this in juxtaposition to the LEMS market, where patients are not diagnosed. They are frustrated. They have a long diagnostic journey. Here, the diagnostic journey is quite quick. And we also see opportunities for newborn testing as well, which should accelerate that. The challenge is that 90% of patients have been on a corticosteroid at some point, but today, only 70% are. This speaks to a gap in the offering that corticosteroids could provide to patients. So there's a wide market gap here. So AGAMREE is a differentiated, uniquely positioned to a differentiated profile, uniquely positioned to address the unmet clinical need. A patient that takes a steroid from diagnosis and takes it continuously will walk for two and a half to three years longer than a patient that does not take steroids. The challenge with steroids is their adverse events.
We want patients to take steroids, but we also want them to be healthy. We'll talk about that a little bit more. So AGAMREE is clinically proven to work. It's equally efficacious to prednisone. It has the potential for significant reduction in steroid-induced adverse events. And we're seeing this play out in the marketplace and the feedback we get from physicians. And the recent addition to the DMD testing to the recommended uniform screening panel by U.S. HHS, or Department of Health and Human Services, could drive earlier diagnosis of these patients, which we think is absolutely outstanding. So we're really excited about this because, again, getting them on a steroid that could be safer for them could create real benefit. So how do we achieve AGAMREE's full potential? So we have a multifaceted approach. We have a strong clinical profile with outstanding acceptance.
90% of the top 100 centers of excellence have used at least one, have diagnosed and treated at least one patient, so we have good penetration here, and we needed to leverage this to further drive HCP awareness, so we have breadth, and now we need to go for depth, so 85% conversion from branded and generic, so there's prednisone and deflazacort, two products that are out on the market, and we're getting 90% of our conversion from those. Our patients are coming as conversions from those two products. 10% are naive. When we first launched the product, we assumed we would go for patients with deflazacort, which was a branded product, just prior to our launch. Turns out we're playing in 100% of the market, which is tremendous upside for us, and then we have to realize the full potential.
We're conducting a phase one study to look at the translational dose between prednisone and AGAMREE, and we're also looking at the immunosuppressive potential for it because other diseases outside of Duchenne's, it would be great to have a steroid that you take long-term in the rare space without immunosuppression, and there's some really interesting data, as I said, that's just recently come out of Europe, so again, looking at the opportunity to evaluate the long-term safety benefits, and we're doing the SUMMIT study, open label, five-year study with up to 250 DMD patients across approximately 25 centers. Real-world evidence, we're looking for a number of parameters. One, improved behavior. Being on a steroid is challenging from the behavioral aspect, especially for young boys and young men. Stature and growth. Long-term steroids, traditional steroids actually suppress growth. They also hurt bone formation.
So you have shorter young men, which is a really big issue in the space for young boys. And then bone health, you can have increased fractures. And then cardiovascular health is the long-term issue, the true long-term issue for this. And this is what most patients with DMD actually die of, is cardiovascular issues. But there's also cataracts, too. And so we're looking for a summit to help us uncover how this might work out for patients, be better for patients. The last product we have is FYCOMPA, and as we mentioned, differentiated epilepsy product, but it actually faced generic incursion the first half of last year, late in the first half. And then actually, its oral solution actually experienced generic incursion in December, but continues to outperform and really do quite well given the dynamics you see in epilepsy.
So here's the performance of the company, as you can see, 17.4% growth third quarter on third quarter, and then a 25.6% growth. So the company continues to do a phenomenal job in execution from a medical and commercial standpoint. And our products, obviously, we're going to expect to see FYCOMPA decline, but we're looking at both products actually taking up the mantle and growing faster and resulting in better growth for the company. So we get asked all the time about guidance and what are you going to do. And we want to just give a high-level update on how the company has done. So for 2025, we actually updated guidance late in the year, and we are looking at achieving the upper end of guidance here. So we're really excited about that.
And then going product by product with FIRDAPSE, we have a very tight range that we held to at our most recent update, and we are going to be within the range, which, again, great performance here. And in AGAMREE, given all the choppiness in this market, you see with Elevidys and other things that are going on, and we don't compete with Elevidys, but obviously, the parents were very concerned about what was going on. So we were looking to make a statement that, hey, this is a good and safe product. It became very challenging for us. And really, here we're looking at or slightly exceeding the upper end of guidance. So again, very exciting for us. And then FYCOMPA, I talked about upper end of guidance here, and we raised the guidance on FYCOMPA late in the year.
As I mentioned several times, because Mike Kalb is very proud of this, as are all of we, but we have $700 million in cash and no funded debt, which gives us the opportunity to really be quite aggressive in the business development space and in investing in the existing products and the lifecycle management of the products. The achievements I'll just go through really quickly. FIRDAPSE, NCCN guidelines we talked about, settled patent litigation with Teva and Lupin for FIRDAPSE. FIRDAPSE launched in Japan. We have a sublicensee in Japan, DyDo. They launched AGAMREE. Sustained continued demand. The product is performing very, very well. We advanced the SUMMIT study, which is critical to the success of differentiating the product in the market. And then we have a sublicensee in Canada, Kye Pharmaceuticals. This is the first product approved in Canada for the treatment of Duchenne muscular dystrophy.
Then on the 26 priorities, pursue immediately or nearly immediately accretive acquisitions. And again, look for that opportunity to work with products that have established proof of concept. FIRDAPSE continue to roll out the NCCN guidelines to those large, high-control oncology practices and advance patient identification on the idiopathic side of LEMS. Again, where 50% of new patients start, greater than 50% of new patients starts. And then protect our FIRDAPSE IP. We have one last defendant, Hetero, and we're looking to defend it. On the AGAMREE drive deeper, as I said, we've gone broad. Now we need to go deep and evaluate lifecycle management opportunities to begin to actually move backward into the development of drugs and develop our capabilities to develop. And then leverage the DMD, our RUSP, which is the recommendation for infantile or newborn testing, and then continue to advance the SUMMIT study.
So with that, I'll take questions.
Thanks. So I'm going to have a few questions, and then we'll open it up to the audience. And then we have some in the audience as well, so no worries. So I'm just going to ask a few, and then. So I guess just first on FIRDAPSE, can you provide some more detail around the two markets that you described, both the cancer-associated and idiopathic LEMS? I think it said $1 billion opportunity. So can you just talk about how you think about the size of those sort of, it's a billion combined, but what is the split between them?
So roughly, they're about the same size. If you were to have, if we were to achieve the market, actually, the cancer-associated LEMS side is slightly bigger, but they're almost split 50/50, but just slightly bigger. So yeah.
Then I guess staying on that, and you mentioned at the end, just with Hetero being the last remaining litigant, can you just talk about your confidence in the IP there and if that goes to trial?
Sure, so I'll give you a time frame. We have a hearing with the magistrate later this month, and then the trial is set to go in late March, and the 30-month stay is set to end in May. However, if the judge doesn't have enough time between the trial and the extension or the 30-month stay ending, he can actually extend it if he wants to, so that's the time frame. Our confidence is really, really high. We had four filers. One was not a first filer, so we have three first filers. Teva was the first to settle, and Teva is a very sophisticated company. They saw the IP.
They had the opportunity, and they decided to settle. And under the agreement we had with them, they could come in in February of 2035. So we have nine years of life left with already having seven years of life in the product. So we're really excited about that. Lupin settled for the same time frame. And again, we're really confident in our intellectual property estate around FIRDAPSE.
And then just one more for me. So just on BD, I know you talked about it at the outset. You mentioned looking at some clinical stage opportunities. Can you just give us a little bit more detail around those expanded parameters that you've put in place and how you think this approach will impact your business development activity and assessments?
Yeah. So we have to look at the capital markets and what's happening with the capital markets.
So in the last two years, the capital markets, as we all know, have been very, very tight. So a company like ours that can actually partner with or license from another company, we have really strong opportunity because of the strength of our balance sheet and our ability to execute. As the markets get a little bit looser and loosen up, we see that this could present a challenge for us. So about a year ago, we started working on how do we get back into the pipeline? How do we move so that we can actually have future-oriented milestones we can talk to with investors and patients? And so we see that opportunity with both FIRDAPSE and the AGAMREE. And we believe that bringing those assets in and developing those capabilities and developing those products gives us an opportunity to have a much more future-oriented story.
So we widen the aperture. We believe that our skills and our capabilities are applicable, as I said earlier, to any therapeutic area because about what any patient group would want is about 90% the same therapeutic area to therapeutic area in the rare space. They want a lot of support. They need that drug delivered on time. They want to talk to other patients. And our infrastructure is there. And we believe we have an industry-leading infrastructure to do that.
I think we have an audience question.
Thank you. Very interesting comments. I have a question about the difference across the three products in pricing, what your assumptions were when you were developing those products. I noticed the first one, you said, has no competition. It seemed like the revenue guidance was roughly three times that of the other segments.
I assume that's reflected in there because they're all about a $1 billion total addressable market. But I'm curious, what did you learn along the way for the life cycles of these different drugs when you were relying on your own assumptions and then when you got to the payer discussions, particularly because it's a very different game in rare disease than it is elsewhere?
Absolutely. Yeah. Great points. Been in the industry for 30 years, 35 years, and I think it's really important to pay attention to what the payers tell you. And so as an example with the AGAMREE, we knew that deflazacort or deflazacort, we're going to have generic entry of deflazacort in the DMD market prior to our launch. So we spoke with 17 decision-makers about what should we do and how should we do it. And we took their guidance. And we see almost no pushback.
You have typical step therapy that's there. But I think listening to the payers and understanding the payer perspective here, and when we do business development, we actually go out and we talk to payers as we're thinking about what products we might bring into the organization. So I think the lessons learned are the payers. We want to make this as easy for the patients as possible. We don't want to create a barrier for patient utilization. We think we all win. The difference in their sales right now is you have a launch curve for AGAMREE, which is still going up, and FIRDAPSE is doing quite well, but had a six-year head start, five to six-year head start. So you're seeing just basic history and the relative size of the two products.
To be really clear, in DMD, I'm not sure that with three other players in the space, I'm not sure that a AGAMREE can achieve the same level of success financially that you would have for a solo player in the marketplace. But again, we want to differentiate the product, show that it has potential to be the best, and then continue that. Thank you.
Maybe I'm sorry. Maybe I missed this in your presentation, but you are acquiring already approved drugs. Is that right? Or are you developing them in clinical trials yourself?
So currently, we developed FIRDAPSE ourselves. We did the development of the product. Today, our strategy is to acquire immediately accretive or nearly immediately accretive. So think of products that are on the market or products that are actually in development.
So as an example, AGAMREE, we acquired the license to AGAMREE while it was post the FDA NDA filing. So we're willing to actually now move backward and take on appropriate risk, we believe.
So why is a company willing to sell it to you? Are they?
That's a great question.
Do they think that they can't develop the market or they don't have the capital to do it? I really am interested in how you're acquiring these products and when you acquire them, number one. The second question is there are a lot of new technologies coming along for DMD, epilepsy, and so forth that are pretty exciting. How are you going to compete with those?
Sure. So first question, why would somebody want to partner with us? Right?
Sell to you.
Well, they may sell it to us. So for instance, we bought FYCOMPA.
Are you buying 100% of the drug? Are you?
We did. For FYCOMPA, we did. And then the other products, we actually licensed from somebody else. So when you look at it, it may be a change in strategic direction. So I think with FIRDAPSE, the reason why we got that was the company had a change in strategic direction. That happens all the time. With AGAMREE, AGAMREE is developed by a Swiss company with not a very strong presence. It had a commercial presence, very small in the U.S. But when they look at what would it take versus what kind of cash they have, they may say the better issue, the better opportunity for us is to actually license this product out. So think about companies that have enough cash to maybe launch but not sustain the launch because launch is typically two to three years.
Or they don't have a footprint in the U.S., and they want to get into the U.S. and establish something in the U.S. So it could be a starter for them to just generate revenue for the company. So that's typically what we see. And then your second question. On the new technologies coming along for DMD, epilepsy, and so forth. So we look at CNS, and one of the reasons why we increased the aperture was because all of the growth is coming in movement disorders. And those opportunities are much bigger than $500 million peak. So that's why we're looking at other areas. When we talk about DMD, to your question, steroids are the foundation therapy. You can see gene therapy coming in. You can see other therapies coming in.
But that patient is going to be on a steroid, we hope a better steroid, and we look for that opportunity. Epilepsy is not a rare condition. We got access to FYCOMPA as a way to improve our cash flow so that we could buy products, build our balance sheet, and go forward. We got great talent. We got great people with that acquisition as well. And that was an acquisition. But our goal is we don't see ourselves in epilepsy in the future. It's very crowded. 90% is generic. High science cells. We love the people we got with it because they're highly qualified, but it's not a long-term play for us. Thank you. Sure.
And then I guess just one to stick on the BD point a little bit. In your presentation, it said 100-plus BD assessments in 2025.
I guess, is that saying you looked at 100-plus potential BD opportunities? And then a question related to that would be, I guess, what did you see as the main reasons why you might not have pursued a particular opportunity?
Sure. So Preethi and I talk about this all the time. Preethi is our head of Business Development and Strategy. We look at three high-level filters first. The first filter is, is the product differentiated, and is there a high unmet need? The second one is we have to be able to earn money. Otherwise, there's no point in servicing patients, right? So we want to be sure that it's a profitable venture for us. And the third element, which I think is typically undervalued in alignments or associations with other companies, licensing or acquisition, is culture and fit. And so we did evaluate at some level 135.
Some went much deeper. Sometimes when you're talking to a company, they'll say, "We believe that the product is differentiated, and it's an unmet medical need. You get into the data room, and it's maybe not as good as proposed." Or to the second point about being able to be profitable on that product, sometimes people have very interesting valuations about what they think they should get for their product. And so we have to be thoughtful and say, "That may be good for somebody else, but we can't go down that road." And then the third one is you get very far down the line, and you learn a lot about your partner, and you say, "I realize we're at the altar, but I can't really marry you. I'm opting out." And that does happen from time to time. It's very rare because you don't get that far.
You typically learn a lot about somebody before you get that far.
So it really just hinges on those three pillars you talked about.
Yeah.
Are the three sort of biggest screening mechanisms, and then from there, it's sort of.
Right. And then we go down, and we talk to payers, and we say, "Okay, is it realistic to do this? What's going to happen with the reimbursement schema?" And always going and diving into the deep and looking at the FDA minutes or FDA communications because we may have a view of our product, but the FDA may have a different view, and we want to know that. So before we do the deal. So there's a lot it goes a lot more goes into it.
Thank you very much. Thanks for your time.