Good afternoon, everyone. Welcome to the Jefferies Global Healthcare Conference. My name is Brett Gallagher with the investment banking team. It's now my pleasure to introduce Richard Daly, CEO, and Steven Miller, Chief Scientific Officer, Catalyst Pharmaceuticals. Thank you.
Well, thank you, Brett. Thank you, everyone, for taking the time out of your busy schedule of meetings to learn more about Catalyst. I'm joined today by Richard Daly, the CEO of Catalyst, and we'll both be available for questions at the end of the presentation. Before I proceed, I'll be making forward-looking statements and future predictions, and I just want to refer you to all of our SEC filings for detailed descriptions of all the risks that are associated with our business. Catalyst is a growing rare disease company that is differentiated by commercial success and our products, a strategic portfolio expansion. We have a highly qualified leadership team with decades of experience in the pharmaceutical industry and a strong financial position, which has helped to fuel our growth through acquisition.
We have a diversified portfolio that consists of two classes of products. The first that I'll be talking about is the neuromuscular franchise that consists of Firdapse and our recently acquired Agamree. And, I'll then be talking about Fycompa, our epilepsy medication. So moving on to the neuromuscular franchise, our flagship product is Firdapse for the treatment of Lambert-Eaton myasthenic syndrome, and I'll have more to say about that syndrome in just a moment. This is a clinically proven therapy that maintains muscle strength and mobility. Most patients who begin therapy respond well to treatment and remain on treatment when they respond. It was approved in the U.S. in November 2018, launched in the first quarter of 2019. It's approved for patients six years of age and older and has orphan drug exclusivity through 2025.
It also has a strong intellectual property estate, providing durability for the product with IP protection through 2037. There's a total of nine patents for this product, six of which are listed in the FDA's Orange Book. Well, Lambert-Eaton myasthenic syndrome is an autoimmune condition that causes profound muscle weakness in the proximal musculature of the shoulder and hip girdle, but in worse cases, can affect all the musculature, and in the very worst cases, can even cause respiratory depression or failure. This disease is. It exhibits symptoms of weakness that prevent patients from getting out of a chair, getting out of a car, walking upstairs, picking up their children, working in the kitchen and putting a can of soup on the top shelf. It's just a number of impacts on quality of life. It also affects ambulation.
Many of these patients have to use walkers or are even wheelchair-bound. It has a unique epidemiological characteristic in that 50% of the LEMS patients also have a comorbidity of small cell lung cancer. Put another way, 3% of the small cell lung cancer patient will develop LEMS during the course of their small cell lung cancer. It affects both men and women equally, and like all autoimmune conditions, it occurs later in life. Well, let me discuss the market potential of Firdapse for just a moment. It has a prevalence of somewhere between 3,600 and 5,400 patients. I mentioned the epidemiology, where half of those patients have a comorbidity of small cell lung cancer. This is somewhat of a prospecting market. We have to carefully search for the patients. The doctors have difficulty diagnosing those patients.
We have to work with the physicians to ensure that the patients—that the doctors are well educated about the condition and that they appropriately diagnose the patients. LEMS patients, in fact, are often misdiagnosed or underdiagnosed or not diagnosed at all and have a difficult journey, and we have made tremendous headway in terms of patient education and physician education to improve the diagnosis rate. In addition to that, in 2019, there was a VGCC antibody test that was approved so that patients... I'm sorry, that doctors had access to an FDA-approved test that is the definitive diagnosis for Lambert-Eaton myasthenic syndrome. In addition to that, we also provide that test for free to patients, should their insurance not cover it or if they don't have insurance.
Well, the growth opportunities for LEMS are going to continue to come from expanded LEMS education for healthcare providers related to testing and diagnosis of the condition, which will lead to more patients that are eligible for treatment. We also have a number of patients that are already diagnosed. The diagnostic journey for the patients is long and complex, and patients who are diagnosed sometimes don't immediately get on therapy for a number of reasons. And, we continue to work on making sure those patients are ultimately put on Firdapse therapy. And finally, we recently had just a few days ago, a supplement approved for increasing the maximum daily dosage from 80 mg per day to 100 mg per day. And 40% of the current patient population is on 80 milligrams per day, the previous maximum daily dose.
Over a period of several quarters, we expect the number of patients to increase, that will be taking 90 or perhaps 100 mg. Overall, we believe that the average daily dose across the entire treated patient population will increase about 5%-10% over the next several quarters. Well, next, I want to talk a little bit about global expansion. Firdapse is approved in Canada, was approved in July 2020. It has a prevalence of about 300 people in Canada, about 1/10 the size of the US. Our partner, who markets that product in Canada, is KYE Pharmaceuticals. The drug has innovative data exclusivity to 2028, and that exclusivity also prevents any applications from being accepted by Health Canada until 2026 that reference our data.
We also have a partner in Japan, DyDo Pharma, who is currently developing the product for that market and will ultimately, market and sell that product in Japan upon approval. DyDo recently filed the NDA in December 2023 in Japan, has a 9-month priority review, and if approved, that drug will be launched in the first half of 2025. The prevalence of patients in Japan is about 1,200 patients, about 40% of the size of the U.S., and those products oral, but, rare disease products in Japan, are granted 10 years of market exclusivity. There's also a unique feature of our license agreement for Firdapse, in that upon the filing of an NDA in Japan, it unlocks the remainder of the Asia-Pacific and Latin American territories.
We are currently seeking partners for commercializing the product in a number of other countries in that territory. Next, I'd like to move on to Duchenne muscular dystrophy, which is the indication for the recently approved and recently launched Agamree product, the most recent addition to our product portfolio. It's the most common form of muscular dystrophy and it's characterized by profound progressive muscle dysfunction that leads to loss of ambulation, respiratory failure, and ultimately to cardiovascular failure and an early death of these patients. It manifests in early childhood and usually diagnosed between the ages of three and five, but due to some hospitals that have routine genetic testing of newborns, it can be diagnosed as early as at birth.
There's a high unmet need for treatments to restore function in these patients, and in addition to that, there are some efficacious treatments that have difficult side effects profiles, and there is an unmet need for a safer drug for those patients as well. Steroids represent the foundation for the treatment of DMD and current steroids that are available to those patients prior to the approval of Agamree had both short and long-term adverse events that precluded doctors from using the drugs as they should have to treat these patients. Quite often, patients start on steroids and later reduce or stop dosing or take dosing holidays. Quite often, physicians prescribe suboptimal doses to try to balance the progression of the DMD disease with the rather difficult side effects that are associated with the older generation of steroids.
Patients also discontinued therapy earlier. The ideal steroid would be a steroid that has this efficacious and has minimal adverse events, which would encourage physicians to start patients earlier, keep them on therapy, use an optimal dose, and patients would stay on therapy longer to hopefully minimize the progression of their DMD. Well, Agamree, we believe, meets this need or has the potential to meet this need. Of steroids, as I said, are the backbone of DMD therapy. The clinical studies demonstrated that there's proven efficacy, tolerability, safety, and ease of use. It has equivalent efficacy to prednisone, but the clinical trials showed that there are a number of adverse event benefits for this drug.
We believe that the product long-term will result in better bone health and growth, and improvements in patient behavior were also observed during the clinical trials. DMD has a prevalence of about 11,000-13,000 patients in the United States. The diagnosis rate is very high. This is very different than the Firdapse market, which is more or less a prospecting market. All the patients are more or less known, and the physicians who treat them are identified. As it says here, 95% of all the patients are diagnosed. At any given point within their diagnostic and treatment journey of these patients, 90% of them will have been on steroids or are currently on steroids. And at any given snapshot in time, 70% of that 11,000-13,000 patients are on active steroid therapy.
This highlights the fact that it is, in fact, the backbone of DMD therapy. Well, the product is now commercially available. It is approved for patients two years of age or older. It was approved in October 2023 and launched in March 2024. It may increase the ambulation duration and mobility, and some of that is yet to be seen. We have a study running called the Summit Study, where we will be collecting long-term data on both the benefits and the adverse events of the drug. We have, this represents an expanded neuromuscular franchise with minimal incremental investment in the sales and marketing efforts. Basically, the sales staff that sells Firdapse calls on the same institutions that are the centers of excellence for the treatment of DMD.
It's an elevator ride or a short walk down the hall to call on first the Firdapse physicians and then the DMD physicians. The product has orphan drug designation, which offers seven years of market exclusivity and has patents that protect it to 2046, six of which are listed in the FDA's Orange Book. Next, I'd like to move on to the epilepsy franchise. This is a first-in-class commercial epilepsy asset that's a mature asset. It's been on the market for quite a few years. We acquired the rights to this drug in January of 2023. The franchise team, the sales and marketing teams were part of the acquisition, and that franchise team was fully engaged under Catalyst management by May of 2023.
The neuromuscular franchise call point actually shares about 45% overlap with the call points that this sales team calls on. It, they don't sell each other's products, but they certainly have the ability to pass leads on to one another, again, giving us more synergy and efficiency in the sales and marketing for the entire portfolio. It has a compelling net product contribution. That was one of the major considerations in the acquisition of this product. It is not a rare disease product, but it was the right product at the right time for us and made a lot of financial sense. And we also seek to expand into rare epilepsies, and that was the strategic benefit of acquiring this product and, more importantly, acquiring the sales of the franchise sales force that came with it.
Fycompa is approved for the treatment of partial onset and primary generalized seizures, and also partial onset epilepsy without convulsions. Well, This is the only AMPA receptor antagonist on the market. It gives doctors a fairly unique mechanism of action to try for the treatment of epilepsy, and it has, it's well-tolerated, has minimal drug-drug interactions and no contraindications. And as I said, from the description of the indication on the previous slides, it has a very broad spectrum of efficacy. It has simple once-a-day dosing, which is primarily due to the fact that it's got a very long half-life, and this relieves the anxiety of breakthrough seizures for patients if they miss a dose or miss their dosing time. And also, it just confers the convenience of taking an epilepsy medication once a day.
It has a 70% retention rate in patients, and the seizure freedom rate is 72% when used adjunctively with other epilepsy medications. This product has patent exclusivity until May of 2025. With regard to the, it was an attractive market opportunity. It's a high unmet medical need. Epilepsy is the fourth most common neurological condition in the United States. There's 3.4 million patients in the U.S., 470,000 of them are children. There's 150,000 new patients each year in the U.S., and 30%-40% of all the people with epilepsy still fail to reach complete control of their epileptic condition with the current available medications, so there's still room for improvement.
And again, this medication, with its unique mechanism of action, gives doctors the opportunity to try another drug in their armamentarium of therapies for epilepsy. Well, there's also... I mentioned that there was a strategic reason for the acquisition of the, this epilepsy product and the sales force that came with it, and that is that, over time, physicians and researchers have been elucidating the mechanism behind epilepsy. And as they determine what the specific genetic defects or, anatomical defects are that are associated with epilepsy, they are finding not only specifically what those causes are, but what the optimum therapy is for those causes. And so the epilepsy business is evolving into a precision medicine business or, more specifically, a rare disease business composed of multiple rare epilepsies.
And so that was the strategic basis for the acquisition because we are, after all, a rare disease company, and so this seemed like an optimal acquisition in that regard, as well as for the good financial reasons that we acquired it. Next, I'd like to talk about our portfolio. First of all, it's not very interesting in the earlier stages. As you can see, all these bars go all the way to FDA approved. But it does point something out that I'd like to highlight. First, you can see the initial approval of Firdapse. Later on, we expanded the label for Firdapse to include the pediatric patients, and just a few days ago, we received approval to expand the label of Firdapse from a maximum daily dose of 80 to 100 milligrams per day.
This highlights our ongoing efforts for not only acquiring new products that make sense for Catalyst, but then once in our hands, making, ensuring that we can expand the use of that product in every way possible, whether it's added indications or geographic expansion that I also went through just a few slides ago. With regard to Fycompa, also an approved medication, and it was late in its development life cycle. It is a mature product, and there was no time to add more indications or do label changes, but we have actually continued to work with researchers to add publications that are disseminated by our MSLs to improve the sales of Fycompa.
And finally, Agamree's a brand-new product for us, and we are currently evaluating the potential for new indications and whether or not new indications will be formal clinical trials and label changes or publications or both. And we'll be looking for other ways to expand the label of Agamree as well. So next, let me highlight some of the financial aspects of Catalyst business. First, you can see year over year, Firdapse increased from $58 million-$67 million for the first quarter, year over year. Fycompa increased from $28 million-$30 million in the first quarter, year over year. I recognize that that's a more modest growth, but honestly, that's what you expect from a more mature product. Now, Agamree doesn't have any increase year over year. It was just approved recently and only launched just a couple of months ago.
So we'll have more to say about its growth in the coming years. I also want to point something out. You'll notice on this plot that it says $1 million for the first quarter. The thing that I want to point out, keep in mind, that's only for the last two weeks of the first quarter, and those two weeks included not only the launch of the product, filling prescriptions, and getting insurance adjudication, all of that took place, and we managed to make $1 million in revenues for this product. I think that it bodes well for the future of this product, and I would encourage all of you to keep an eye on this one because we think it's got great growth potential.
So the total revenues for Catalyst quarter-over-quarter were $85 million-$99 million. This next slide has a lot of the same information on it, but the column I'd like to direct your attention to is the percent change column. You can see the overall net product revenue for the whole company increased 15%, and we've been doing that many quarters in a row. The Firdapse net product revenue increased sixteen-- about 16%. Fycompa, modest growth, but it's still growth, 9.5%. And again, Agamree, no % growth to tell you about yet, but there will be. There's one other thing I'd like to highlight on this slide. You can see we have both GAAP net income and non-GAAP net income.
Because of the GAAP rules and the impact of those rules on how you account for both amortization of acquisitions, as well as R&D expenses associated with acquiring products that are not yet approved, the GAAP—the non-GAAP income is actually a better indicator of how the company is performing, and I would encourage you to review that, to refer to that figure when assessing Catalyst. I'd also like to point out our financial position. You can see we have $310 million in cash. If you review past quarterly reports, you'll see that we drop approximately $20-$25 million to the bottom line per quarter, so that cash will continue to grow. And finally, one last thing I want to point out. You can see the graph on the right has the continued growth.
You can see the organic growth of Firdapse there in the blue bars. You can see the added revenue from Fycompa, and you can see that little, tiny green slice over there on the last column, that's Agamree. That is the one that I expect to increase significantly over time. This slide is our value drivers. In the interest of time, I'm just gonna concentrate on the anticipated 2024 milestones. First, we published our 2023 ESG annual report and got a good score. I recognize that that does not contribute to revenues and profits, but what it does do is highlight the fact that we're a good corporate citizen and who's well managed. We also been pursuing strategic expansion and lifecycle plans, and that is where the acquisitions came from, and those acquisitions will not be our last.
We continue to review things and plan for future acquisitions as well. We're pursuing global partnerships to expansion plans. We received approval for the increase in the maximum daily dose for Firdapse just recently. We expect a nine-month review and approval in late fall for the Japanese NDA, and then launch next year. We continue to seek opportunities to enhance our IP estate. In fact, two of the patents for Firdapse actually were issued this year. We have commenced the U.S. commercial launch of Agamree, which I just went through on the previous slides. So the last thing I want to go over is our growth initiatives. We are building on our momentum.
We are evaluating as many products as we can, looking for appropriate products to add to our pipeline to grow through acquisition at this point in time. We explore many commercial add-on assets, both in the U.S. and globally. We have a lot of synergistic experience to foster the innovations. We have a staff that has decades of experience in all aspects of the pharmaceutical industry and can harness that, not only for the operational excellence of the company itself, but also for the evaluation of these assets, because it's important to make sure that the assets are technically good assets, and they have good IP, and that the regulatory structure is correct, and that we'll be able to ultimately commercialize them, and that they'll be good drugs for patients. Because if they're not good drugs, nobody's gonna wanna buy them, no matter what we do.
We seek partnerships to accelerate growth in new therapeutic areas, and we are doing geographical expansion. And finally, we have a strong balance sheet that reinforces executing on these opportunities. The bottom line is that even if we find a great opportunity, we have to make sure we have a big enough checking account to actually acquire the assets. And so overall, we're well-positioned for continued long-term growth, like the growth I've already showed you on the previous slides. And so with that, I want to thank you for your time. And we have a few minutes to take questions. Rich is here, our CEO, who can take some, or perhaps I will. So with that, we can open it for questions. I think we have no questions, so I want to thank all of you again for taking the time-