Good afternoon. I want to thank Jefferies for the opportunity and to present today. We are really excited about being here and looking forward to your comments and questions. Obviously, the usual and standard State Farmer. Catalyst is a buy-and-build, commercially focused organization with all of its business in the United States. We look for opportunities to acquire products and commercialize them. Our business model is one where we reduce risk, and we operate exceptionally well in the commercial space in the US, and we will show you some examples of that. Our focus is on rare disease and working with rare disease communities. One of the things that we do that is a little bit different and a little bit more intense than most rare companies is we have an incredible patient support program.
When you think about the patient support program, the thing that you should focus on is the opportunity to get the patient on, keep the patient on the drug, and optimize the therapy for the patient's benefit. This becomes really important in the rare disease community where there's not a lot of support for patients. One of the things we do, we have patient access liaisons. This is a group of field-based folks who really work with the patients in a permission marketing kind of way. The patients express an interest in working with some because of the challenges they've had in getting diagnosed, and we see a lot of success here. We also have patient ambassadors. These are patients who volunteer to help with other patients, and we have a very robust network there. A core to our belief is access to therapy.
Once a patient on a Catalyst drug starts on a Catalyst rare drug, regardless of their ability to pay, we keep them on. Some of you may have heard about the Change Healthcare cybersecurity attack last year. We saw that right away because we have a proprietary pharmacy. We got the note from the pharmacies that the patients were not getting reimbursed, and our decision at the time was to give those patients drug immediately. One of our drugs, Firdapse, is used for Lambert-Eaton myasthenic syndrome. In some cases, patients who stop taking that drug for a couple of days will lose the ability to walk. It is really important that we make that patient promise, and this is the core of who we are. As it turns out, for the Change Healthcare situation, we were reimbursed 100% for all of that.
We didn't know it at the time, but that's our commitment, and that's one of the things that makes us different in the space. We look for the opportunity to do a lot of healthcare provider education as well, and then we provide free testing. In the LEMS space, VGCC test is critically important to diagnosing a patient, and we offer that up. It's a relatively inexpensive test in the US. It's about $65. Interestingly enough, when Marino was presenting in the previous session, the number one misdiagnosis for Lambert-Eaton myasthenic syndrome is myasthenia gravis. We see a lot of opportunity with all the success of targeted therapies in the myasthenia gravis space. More patients will get diagnosed, which is good. More patients will get treated, but some of those patients will not have myasthenia gravis and, in fact, have LEMS.
We see this as a great opportunity. What do we do? As I said, we are patient-centric, commercially focused. This is a risk mitigation strategy for us as a company. We do no R. We do not do D, and we just take products to market because we are willing to take the commercial risk for the opportunity. The two main pillars of our business are optimizing our commercial portfolio and then business development as well. We will talk about some optimization opportunities. We are a company that really focuses on operational excellence as well, and we have proven capabilities. We have had successful launches in the space, and we continue to seek opportunity to work with other companies to launch their products. In fact, more than 90% of our business development assessments are inbound because of the reputation of the company. We are financially flexible. We have a strong balance sheet.
We are a profitable company in the rare space, which is, in and of itself, rare, and so we're really proud of that. We work exceptionally well to deliver for shareholders. We talked about organic growth. We look for the operation here and acquisition-focused growth. We're always looking for products to apply our model. Our model, again, is really focused on that field-based team, not only in sales but in patient support, but also in the support that's behind that. What's really important here and what most people do not see in the rare space is the patient support between the hub, the patient hub, the specialty pharmacy, and the 3PL, the third-party logistics provider. We bring that all together, and we actually service the patient community quite well.
We launched in 2019 with Firdapse, and we've added a couple of products since then, and you can see a 37% compound annual growth rate. We have three products right now. Firdapse is the only evidence-based medicine on the market in the US for the treatment of Lambert-Eaton myasthenic syndrome. We'll talk a little bit more about each of these in a moment, but we have Agamree, which is a novel corticosteroid for the treatment of Duchenne muscular dystrophy. And then we have Fycompa, which is a drug for epilepsy, and the solid dose of that went generic in May of this year, and the product has actually outperformed expectations even in the face of generic competition. If you are familiar with the epilepsy space, you know that patients are stickier in that space, and so this is a really good space to be in.
We're actually able to replace the revenue lost here with the growth in the other two products. Let's talk about LEMS for a second. LEMS is a very limited community in the US, ultra-orphan, in fact. Between 3,600-5,400 patients might have LEMS, and it's a really interesting market because about 50% of those patients have cancer-associated LEMS, typically with small-cell lung cancer. 50% are idiopathic, not associated with LEMS, and we'll talk a little bit more about that in a second. One of the things that's really intriguing about this market is how do you find patients? This is a prospecting market, so you have to keep at it. The average physician in the US sees one LEMS patient in their entire career, so it's very challenging.
What we've done and what our team has done under the commercial leadership of Jeff Del Carmen is actually create a pool of patients who are on a diagnostic journey, and we prioritize those, and we reprioritize, and we look at the hyper-list, the hyper-prioritized list. When we see those patients coming through, this is through data and artificial intelligence and machine learning, we are able to identify where those patients might be. We talk to the physician, and we talk to them about what LEMS actually looks like because its differential diagnosis is different, as you might imagine, from myasthenia gravis, although frequently confused with myasthenia gravis. We have a pool of over 500 patients, and every month, every quarter, every year, 50% of our patients come from this pool.
It's an incredibly efficient system, and the commercial team has done a wonderful job at identifying patients. Our key growth drivers here for Firdapse are really just optimizing the daily dose. Patients generally start at a 30 mg dose, and then they don't progress in their dosing in the scale-up. They should go up 5 mg every three days. We've instituted pharmacy programs to call the patient, see how they're doing, and that's actually working out. It's a newer program for us, working out quite well, and accelerating the diagnosis of LEMS, again, with the free testing, helping the physician understand what's happening there, but also unlocking the growth opportunity in cancer-associated LEMS. We'll talk a little bit more about that. This product, at today's prices with addressable market in the United States, has about a $1 billion opportunity here. This is a phenomenal opportunity for us.
We've settled with three litigants in our patent case. We have one left to go, and we've settled with the three litigants to February of 2035. With nine years of commercial life left, we are really excited about this. We have no problems with getting approval. We have high retention here because it's a highly symptomatic condition, so patients, when they are treated and the drug is effective, they stay on the drug and they refill. We talked about the enhanced support already. Let's break the market down. We talked about this 50/50 split between idiopathic and cancer-associated LEMS. About 1,800 patients. Life expectancy on the idiopathic side is unaffected. These patients live a normal lifespan. On the oncology side, things get really intriguing. There are about 1,800 patients. A small-cell lung cancer patient will live about nine months.
Interestingly enough, a small-cell lung cancer patient with LEMS lives about 17 months. Nobody knows why, but the data are out there. Each year, there are about 150 patients on the idiopathic side that are diagnosed or could be diagnosed, and there are about 900 on the cancer LEMS side. We see the addressable market is about 80%, so we take those who are diagnosed but really are asymptomatic and perhaps those who are diagnosed and might not experience a benefit of the drug, and we take those off, and we look at the opportunities, about 80% in both. Our market penetration on the idiopathic side is 30%, and this is the prospecting side of the market. Very challenging, but we have good systems to support it and support growth there.
The cancer-associated LEMS, we only penetrate about 10% of this market to date, and we are working with group purchasing organizations in the US to actually get more testing done and more treatment. This is an oncology-based therapy at its core. What we're seeing here in the US, three group purchasing organizations control about 80% of all oncology practices, and we are targeting the high-control, high-volume practices to institute testing, and we've been very successful in bringing this forward. What are we doing? We talked about the 50%, I'm sorry, the 500 patients on the idiopathic side. Again, generalized myasthenia gravis is a tremendous opportunity for Catalyst and for Firdapse. We refer to this as the best money we never spent. You see all this direct-to-consumer activity in the US.
Diagnosis rates are increasing, and we see an opportunity to actually use that as a strong tailwind for us. We increased the diagnosis rates, and we talked about VGCC testing, and then growing awareness of the updated testing protocols. On the cancer side, we've done a lot of work to build this up, and we look at this as a well-thought-out four-step approach. First is to get frictionless testing. Prior to our engagement with national labs in the US, a patient would get a blood draw in an office, or say they would get a diagnosis. They would have to leave the office, go to a distant site, let's say Quest Diagnostics is a big lab provider in the US, and they would have to get the blood test. The patient would get the blood test back and have to go. We've taken that away.
We've done a deal, cut a deal with Quest Diagnostics to do the testing and the pickup in the office. Makes it very convenient, frictionless. NCCN guidelines are the driver of therapy in the US and elsewhere as well in the world, and we have worked tirelessly over the last three years to update the NCCN guidelines as it relates to small-cell lung cancer should LEMS be suspected. This August, we actually got approval for an updated NCCN guideline, which states that you should do a VGCC test, and Firdapse is the only evidence-based medicine for the treatment of LEMS. The next two steps we are working to accomplish, which is embedding these changes in the care pathways, again, focused on high-control, high-volume accounts, and then working on education to drive the adherence to those guidelines.
On the DMD side, switching to Agamree, DMD has been in the news a lot lately. The way you should think about steroids for DMD, if you're not familiar, steroids are the foundational therapy. They are the drug that other drugs get added to, not the drug that gets added. What you're looking at is a lot of activity out there in this space, but steroids are the way to go. A patient who takes steroids consistently will walk for two and a half years longer than a patient who does not. Getting a patient on steroids is really important. The challenge with the market you see here, 95% of these patients are diagnosed. This is not a prospecting market. 250 physicians operate in 100 centers of excellence in the United States. We know where the patients are. The challenge is the therapy that's available.
90% of patients have been on a steroid, but only 70% remain on a steroid. That speaks to a yawning gap in what's happening in the marketplace. What could we do better? We recently, the innovator of the drug, our licensor, Santhera out of Switzerland, came out with a study, a five-year study with 111 patients looking at the potential difference in standard-of-care steroids and Agamree, and what they found was that patients who are on steroids have smaller stature. They don't grow as much. They have weaker bones. They have higher fractures, and they develop cataracts. On all three of those elements, Agamree was superior to standard-of-care. We're really excited about this opportunity. You can see the growth drivers here. We've penetrated 100% of the top 45 centers and 90% of all centers with at least one prescription.
This product's only been on the market for less than two years. So the transition of existing corticosteroid treatment is 85%. So there are four products on the market here: Prednisone, which is generic, Emflaza, which is a brand in the US, and Emflaza generic. So while this product, this opportunity is also a billion-dollar opportunity, we are playing with three other players. So when we talk about the potential for the product versus what you see on the screen here, potential for the market, it's much different than Firdapse. We're very excited about this product. We're very excited about the uptake, and we think all else being equal, we should get our fair share. However, the data we're seeing from things like the Guardian Trial, which I just spoke about, indicate that this product might be superior to standard-of-care steroids. So what are we doing about that?
The label in Europe is very robust. The label in Canada is very robust. The label in the US is a little bit less robust. We have started the summit trial to actually test for these benefits: behavior benefits, stature, bone health, and also cardiovascular and cataracts. The number one cause of death for a patient with Duchenne muscular dystrophy is cardiovascular. We are looking at this over five years. This is 250 patients, not subjects. These are paying patients we will track for five years. Also, since it is an open-label study against standard-of-care, historic standard-of-care, we can be looking at the data as we need to without sacrificing alpha. We are excited about this, and this study is currently enrolling patients. We have Fycompa, as I mentioned, great therapy, the only drug in its class on the market, and actually has greater sticking power than originally thought.
Unfortunately, it did go generic. The solid dose went generic in June, and then the liquid dose will go generic in December. Again, outperforming expectations significantly. When we look at this, we're exploring all sorts of synergistic opportunities. We're disease area agnostic. Our business development efforts are very, very strong, and we're looking at differentiated therapies that can make a difference for patients. We want immediately accretive or nearly immediately accretive opportunities because, obviously, we're a commercial organization, and we want to be moving forward as aggressively as possible. These are all things we've talked about: established track record, exceptional commercial capabilities, best-in-class support programs, and deep expertise with these communities, which matters. This is our performance. As you can see here, total net product revenue grew 17.4%, and year-over-year, the first nine months, we've grown 25.6%.
Really outstanding performance on the part of the company, and we're really proud of this. As we mentioned earlier, compound annual growth rate of 35%. We updated guidance in our most recent analyst call, and we're looking at $565–585 million in top line. We updated guidance on Fycompa and Agamree in the call, and we are holding guidance on Firdapse. We're really proud, again, of this performance. Breaking it down a little bit further, you can see that the growth rates you see here and the growth year over year on net income, GAAP, non-GAAP earnings per share, and diluted earnings per share. The company has performed really well.
Again, we're a profitable company in the rare and orphan space in the US, and we have $689.0 million of cash on the balance sheet, which we intend to use for the acquisition of products or partnerships. We have no funded debt. I think the company's in a very, very strong position to act aggressively in the marketplace and continue to grow. We look at the achievements for 2025, quarter two or year to date, I should say. Obviously, the 15.3% in total revenue, obviously different than the net or the product revenue. We settled the litigation with Lupin. As I mentioned, we settled three out of the four. On August 6, we got updated NCCN guidelines, and we announced the share repurchase, a 15-month program where we can do as much as $200 million.
We believe this is a really prudent thing to do and does not impede our ability to actually do deals. We have a strong balance sheet. We have strong cash flow, and we are really looking forward to actually returning that value to the shareholders. Our sub-licensee in Canada got approval for Agamree. Hard to believe that Agamree is the first product approved in Canada for the treatment of Duchenne muscular dystrophy. That, to me, is amazing. On the priorities, obviously, we want to accelerate the education and promotion in the oncology space. We think this is a phenomenal driver of value for us and for patients, and we want to protect our intellectual property, which is really important to us.
We have one outstanding litigant or defendant, I should say, and we want to settle those cases, but we're going to do so in a way that benefits us and our shareholders as well. Drive sustained organic growth. We've got that opportunity with the 500 patients we talked about, and then pursue synergistic assets through our business development activities. Again, fully enroll the summit study. We're looking forward to doing that as quickly as possible. Thank you. Happy to take any questions. Thanks for your time. Appreciate it.