My name is Pavan Patel, and I'm one of the Biopharma Equity Research Analysts at B of A. I'm joined today by Rich Daly, CEO, and Steve Miller, Chief Operating Officer and Chief Scientific Officer of Catalyst Pharmaceuticals. I guess we'll start off today more, you know, high-level, strategy questions. First, can you speak to how actively the company is engaged in finding another BD deal, and how important is it to have an asset to mitigate any near-term FYCOMPA-related generic headwinds?
Well, Pavan, thank you. I want to thank B ofA for the invitation to be here today. So we're really appreciative. So thank you very much for the support that the bank's given us. So on the strategy, you know, we're looking at the opportunity to go into, stay in the orphaned space, obviously, and spend our time looking at opportunities to broaden our opportunities in the space beyond CNS. We like the opportunities that we see out there, and we are deeply engaged in multiple conversations with many, many bankers, sorry, I apologize for that.
No, it's okay.
Many, many companies for the opportunity to build our portfolio. We are a buy-and-build company. We've done a really good job of buying assets and integrating them into the business, and then executing on the assets that we have. We're really excited about FIRDAPSE. We've done a really good job there. The growth there is phenomenal. It's double-digit, 15%-20% year-over-year for five years. FYCOMPA was a great asset for us. It's a solid player. And then we look at the launch of AGAMREE, and we're really excited about that. So we continue to look in that space, and we see ourselves as an orphaned company looking to expand beyond CNS as well.
Maybe can you walk us through the criteria in terms of deal sizing?
Sure.
The stage of the assets and the therapeutic areas that you're looking for? And then the second part of the question is, you know, in what time horizon do you think you're going to move beyond the buy-and-build stage as a company and move into developing R&D capabilities?
Great, great questions. So, we want to buy assets that are immediately accretive or nearly immediately accretive. We want to build on that income statement and build the balance sheet. So we look at things that are either on market, the NDA is filed, or the NDA is about to be filed. So phase 3 is pretty much over and done. So we're mitigating our clinical risk. We're willing to take on reasonable regulatory risk. And then we really understand the commercial space, so we're willing to take that risk on because we understand that, and we face that risk really well. Moving beyond those things and moving further back into the pipeline, Steve and his team did a great job of developing FIRDAPSE.
We had a development organization at one time, and we did that really, really well to bring that product to market. And again, you look at the way that product was developed and delivering 15%-20% growth for five years in a row, that's phenomenal. So we want to work our way back into the pipeline again at the appropriate time because we believe that there are inflection opportunities there that will help drive the value of the company. But right now is not our time. We still need to build that diversity and opportunity in our income statement and so that we have that stability across the entire income statement so we can feel a lot more comfortable taking what we believe is measured risk from a development standpoint. We're not there yet. So time frame to be measured.
I think, you know, another asset acquisition, another, digest it, see where we stand, and go from there.
Last question on BD before we move on to the product portfolio. In terms of deal sizing, I mean, we see the cash on the balance sheet and the cash flow generation, but, are you willing to take on any debt to, you know, flex, in terms of deal sizing? I guess Pat's philosophy was that he was averse to debt, but do you have a similar, sort of view on that?
Yeah. You know, so when you're a startup company, obviously, you know, I think you want to be very, very, conservative in your approach to how you run the business. I give kudos to Pat. What a phenomenal job. What an absolutely phenomenal job he and Steve did in shepherding the company through some very challenging times. I think the leadership that he showed, in, in, over the years in bringing the company to where it is. I mean, if you did a screen on companies that were, CNS, orphan, and profitable, I think you might find one. And that's us. Pat did a great job. Pat's obviously our chairman of the board now, and we've had a number of conversations. We have about $300 million on the balance sheet right now, and we want to put that money to use.
Would we go higher than that? Could we take on debt? The answer is yes. Absolutely, we would do that. For the right deal at the right time, we would absolutely do that. Yes.
Perfect. Let's get into the product portfolio. So AGAMREE, this is the newest product that you guys have added to your portfolio. And you had launched the product on March 13th.
Right.
Can you speak to the pre-launch efforts and the number of unsolicited requests for patients to get onto AGAMREE, and how do you expect that to benefit early revenue generation?
Sure. So yes, no, and yes. So, so I can speak to the early marketing efforts. We did an early enrollment starting December 1st, and we got a number of patients engaged with us. We did our early earnings announcement on December, sorry, on February 29th, and we gave guidance for the product and launching because we saw what was happening with the product and the interest in the product and where the patients were coming from. So Duchenne's, there's not an opportunity to grow this market. This is a cannibalization opportunity. And so we saw where they were coming from. We saw a lot of parameters about the patients, and we had a lot of confidence about what was happening in the marketplace. So, we were really excited about that.
We have not given guidance or not given any indication of the numbers of patients. So that's the no part of it. I apologize for that. What was the third part of your question?
I guess, I don't know. The third part of the question was.
Sorry.
How do you expect that to benefit early revenue generation?
So, so great. We had about $1.2 million in revenue in the first two weeks of the product or the last two weeks of the quarter of the product launch. And so really excited about that. We see these patients rolling through very quickly, and we're getting approval for these patients. And we're really excited about that because of the potential benefits we think this can bring for the patients and their families and the communities in which they live. We think there's a lot of opportunity here. But we also saw physicians being very conservative in letting their patients enroll in the program, this pre-commercial launch program, because they didn't want the patients to be disappointed.
So they said, "Wait till the product actually launches, even though the product is approved, and we'll let you enroll in this program." And what we said and we were very clear about this, we expected first-quarter sales to be very thin. That's something I said probably 100 times. It was expected to be very thin. But then we expected to step up in the second quarter. And so we really saw this once the product was launched, was announced, we saw a significant step up in enrollments. And so we expect this to carry over into the second quarter and beyond. So we're really excited about that.
So longer term, like, do you expect can you describe where you expect patients to come from, whether that's prednisone or EMFLAZA? And how does the generalization of EMFLAZA impact your outlook on the launch for AGAMREE?
Great. So, because of this, pre-enrollment, we did, we have great insight into where the patients are coming from. Again, a cannibalization market. So 47% of the patients who were pre-enrolled prior to the launch of the product were from EMFLAZA. 41% were from prednisone, and 10% were naive. Or the remainder, I should say, were naive. So the opportunity there is really interesting because we expected it mostly to come from EMFLAZA, but there's a lot of interest in potentially in products that might be potentially better than what's on the market. So we're really excited about that opportunity. So as we go through this, we see that, you know, there's this opportunity to improve the standard of care. And so we want to take this and help the patients get better, so.
Maybe I'll turn to Steve next.
Sure.
In terms of AGAMREE's clinical profile, what aspects do you think differentiate it the most in the treatment landscape?
Well, during the clinical trials, it was observed by the physicians and the patients and caregivers in that trial. Anecdotally, they observed much better behavioral patterns from the children who were taking the drug. It's a little too short to observe growth, but there were some comments about growth. And generally, they observed less side effects that were corticosteroid kinds of side effects. And it's a result of all those observations that both the caregivers and the doctors are very optimistic about the future for AGAMREE and are willing to give it a try.
Is there any additional data that you might, you know, publish or present, in terms of a head-to-head versus prednisone on bone biomarkers and stature?
I think most of the data versus prednisone has already been published. We are actually starting a study called the Summit Study that will run for at least five years in which we will collect data from a number of patients who will be treated with AGAMREE. The purpose of that study is to collect additional safety data so that we can periodically update our label. The study will be conducted in accordance with the FDA's guidances on the use of real-world data to amend and expand your product label.
Great. Let's move to FIRDAPSE next. Maybe in terms of the small-cell lung cancer opportunity within LEMS, can you speak to the baseline contribution and how you expect that to evolve moving forward?
Sure. So, about 25% of the patients on FIRDAPSE in our FIRDAPSE patient pool come from small-cell lung cancer. We recently, last year got the testing for small-cell for LEMS added to the NCCN guidelines. And we're working with NCCN to get FIRDAPSE added to the guidelines as well because FIRDAPSE is the only approved product. So we expect that to grow over time.
Can you speak to what drives the assumption or the guidance that, you know, FIRDAPSE is going to grow 15%-20% year-over-year?
Sure. So this is a prospecting market. So we look for certain market markers in the market as to what physicians are doing. So, the average physician will treat one LEMS patient in their entire career. So it's not like you can go to IQVIA and find, you know, which physicians are the top deciles. Or, like, that's not the way this market works. But we look for markers, and then we create a pool of 50 patients who are on the treatment journey. And we have a patient pool of 500 who are in the journey. And we go out and talk to those physicians based on the markers that we find. And then as those patients progress through their journey, we actually help the physician identify that they actually have LEMS, not myasthenia gravis, which is a common misconception and misdiagnosis.
We help the physician to get them onto the appropriate therapy. If it's FIRDAPSE, great. Half of our patients every year come from this patient pool of 500.
And so how do you, how does the sales force go out and improve either diagnosis or treatment rates? And what are the levers that they pull? I mean, I guess the first thing that comes to mind is the antibody testing.
Well, we actually offer free antibody testing for those patients who simply don't have the proper insurance that pays for it. Most of the time, it's paid for by insurance. It is an antibody test for the antibody that is actually the cause of LEMS. And the physicians basically are trained both through a number of non-personal promotion items as well as interactions with our medical science liaisons who help the doctors understand that this is how you diagnose the patients, and upon diagnosis, the treatment for LEMS is FIRDAPSE.
Then moving on to the legal, you know, you know, the legal stuff that's going on, what's the next milestone in the ongoing suit with the Markman that might come up in the near term?
Yeah. The next thing that would happen in the progress of these suits is what's called a Markman construction hearing, which should be in the near future. There's not a lot I can say about ongoing litigation. I'll just tell you that we recognize that it can give cause some uncertainty in the minds of investors. We're working hard to bring this to as quick a conclusion as possible, and as favorable a manner to Catalyst as possible.
Yeah. And then for the method patent, how common is it that the doctors are determining dosing regimens based on NAT metabolism status? You know, I guess, you know, this is an issue that we've seen come up, whether these dose optimization schemes are actually even used in common, commonly in practice.
Well, because the dosing administration section of the insert sheet has a low starting dose, they're effectively practicing the invention with every patient.
Okay. Then, on the second method patent covering methods of detecting drug degradation, is it safe to say that you think generics need to copy the patent, or they'll produce a product that will fail to show equivalence due to the degradation issue?
Well, the specific degradant that's called out in those patents is a Amifampridine dimer that can be formed in a number of formulations. So the generic innovators, the generic developers of FIRDAPSE are going to have to develop formulas that don't develop that impurity.
Yeah, so we have a minute left. I guess I want to go back to the strategy. You know, you stated that you're going to go out there and acquire another asset. So in terms of the therapeutic areas that you've had a few months at least now to go out and do these screens. Maybe if you could share what therapeutic areas excite you the most, and what you're seeing out there in the landscape.
So obviously, we like CNS a lot. Well, that's an area we concentrate in. But we also are looking to expand because we want to be sure that we're covering the opportunities that exist. And we don't want to compete in a space where we can't, obviously, compete with the bigger players. We're, we're looking for smaller opportunities. So we like cardiometabolic. We like immuno-oncology as an example of smaller spaces too. We believe that the structure that we have as a company is one that enables us to compete across the board.
Great. With that, I think we're at time. I want to thank everyone for attending. Thank you, Rich.
Thank you.
And Steve.
Thank you for having me.
My name is Mike Ryskin, and I'm on the Bank of America Life Science Tools and Diagnostics team. I'm excited to welcome our next speaker. We're joined by Sam Raha, Chief Operating Officer of Myriad Genetics. We're going to have a quick presentation from Sam. Okay? Thanks so much.
All right. Thanks for coming.
Yep. All right. Maybe I have a dual mic here. Hello, everyone. Happy to have the opportunity to provide you with an update on Myriad Genetics, our recent Q1 results, as well as what lies ahead. First, for your enjoyment, the customary Safe Harbor Statements. Let me start with an overview of Myriad. We are a leading molecular diagnostics company and a precision medicine company, focused on oncology, prenatal health, and mental health. We are a pioneering company with a history of over 30 years of breast cancer diagnostics. We're deeply rooted in science and medicine with over 1,000 publications, and counting. Last year, we served over 1.4 million patients by working with over 50,000 healthcare providers. Now, we've also delivered multiple consecutive quarters of strong revenue growth, including Q1. I'll get into that in a moment, while having industry-leading gross margins as well as a healthy balance sheet.
Let me dive into Q1. We're off to a good start thanks to all the contributions from colleagues across Myriad. We posted strong results and are looking forward to the full year. Revenue in the quarter, we delivered 12% revenue growth, including 2% contribution from ASP improvement. For the full quarter, positive EBITDA adjusted of $4 million. Pardon me. Along with EPS, or I should say, loss of $0.01 per share, both of which are material improvements from first quarter of 2023, just as planned. Now, looking to deliver on our business and financial objectives, we are making good progress on our strategic priorities for the year, including the integration of assets we acquired from Intermountain Precision Genomics, including optimizing our focus on EMR integrations, on the reorganization of our international operations that we announced last year last week. Pardon me.
I will also tell you that we're seeing early wins from our, from the market competitive dislocation, though we expect really the impact of that to be in the second half of this year and going into 2025. We're also excited here on the, the last column of the slide, to be working on and launching a stream of new products, in, in the coming quarters. More on that in a moment. You might have also heard that recently, the FDA announced its ruling on LDTs, and we believe that we're well-positioned to operate within that new framework.
Now, in order to deliver on our mission of increasing health and well-being for all and our objectives of sustained double-digit profitable growth, we're focused on four pillars, if you will: science and innovation, always keeping that in the forefront, and utilizing technology to improve the efficiency and productivity of our operations, scalability and operating excellence when it comes to commercial lab operations, all our supporting functions, and always at the heart of it is elevated customer experience, and doing that digitally and by other means. And all of this, our pillars are focused excuse me, are informed by our deep understanding of what healthcare providers are most interested in. And you can see it here on this slide.
You know, there's no substitute for clinical utility, and validity, having the right breadth of products, which is something we've been continuing to improve on, including the Intermountain Precision Genomics recent acquisition, turnaround time, supported by our Labs of the Future initiative, ease of use all the way from learning about our products, ordering, through getting, getting testing reports. Now, we're excited about serving these healthcare providers and actually the overall markets that we're that we're participating in, and based on a strong portfolio of products that we bring. The key takeaway from this slide is that we are playing in attractive, sizable markets which have good growth, and we have an opportunity not only to grow with the market but to really accelerate growth and grow into some of these spaces.
I'll note that, in three of these eight segments, we are actually the, the market leader, and in other three, we're, we're within top three. The opportunity for growth and, and our double-digit profitable growth is enabled by these attractive markets that we're that we're serving. I want to take the next several slides and go just a little bit deeper on oncology. Now, cornerstone of our portfolio, is hereditary cancer testing, a particular product called MyRisk. Now, along with the volume growth that you see on this slide, we've had very strong revenue growth, multiple consecutive quarters, and in fact, 16% revenue growth in the quarter for hereditary cancer testing. We attribute that to a combination of the reputation that we have in the market being a leader, along with, the, the focus, for our sales team getting ever better and delivering the messaging on our differentiation.
We're also starting to see some, you know, early, market dislocation, all of which, presents us with an opportunity for continued growth. I'll tell you that, we believe, though, hereditary cancer is the cornerstone, and though it's a mature market, there's a lot of opportunity ahead for, for continued growth. What you see on this slide are the two subsegments of hereditary cancer testing on the left-hand side, the unaffected market, right-hand, the affected, market. Just if you look at the unaffected side alone, there are more than 50 million women that qualify, based on guidelines for hereditary cancer testing every year. And there's a significant percentage of those women that are not getting tested today. So we are seeking out through our analytics, and better identifying, who those women are and finding ways to, to serve those, those women.
Part of how we're reaching this new subsegment, if you will, underserved segment, is looking at where imaging is done today. This includes major imaging centers such as Walmart and SimonMed Imaging. These are partnerships that we've established to have better access and to serve patients at where they are. The takeaway from the slide is this continues to be a large market where we see robust growth opportunity for quarters and years to come. Now, our MyRisk test is differentiated in a number of ways. One thing I want to talk about is RiskS core. Now, core to our focus as a company is increasing access to genetic-based tests. Risk score is actually a polygenic RiskS core. It's the only one of its kind for breast cancer that was developed and validated with multiple ancestries in mind.
By leveraging this, you get better, you know, better diagnosis, prognosis, and diagnosis of individuals who should be screened and should have follow-on treatments, because based on their familial history. This is both a competitive differentiator for us at Myriad as well as a way that we're really expanding access to genetic-based diagnostics for a broad set of population. I want to talk now about our excitement for a number of new products that are on the horizon. First, in oncology, through the acquisition of Intermountain Precision Genomics assets, we are now offering Precise Tumor. This is a comprehensive genomic profiling assay that helps doctors in therapy selection based on more than 520 genes that are assayed. This is something now fully within our control.
We've already improved the turnaround time for what was, in more than 50% of the case, more than 21 days, down to 90% of the time within 14 days. Early next year, in the first half, we're looking forward to building on Precise Tumor and bringing Precise Liquid to market. This is similar tests in terms of content but starts with blood. And increasingly, as you know, there's a trend where oncologists are, you know, when tumor tissue is not available, and even in the instances where patients are better served with starting with blood in a more non-invasive way, this is becoming a popular path. We're excited about that. Then let me talk about Precise MRD. We're very excited about this, the product that's under development. You know, at the core of our product is a differentiation based on sensitivity.
We use a whole genome sequence-based approach for tumor selection and follow it up with a smaller subset of targets that we look at for the ongoing monitoring. The sensitivity of our assay is shown to be 10 times more sensitive than many of the commonly available MRD tests that are on the market that are ahead of us. And this is important because for many cancers, they're low-shedding. That means there's very small amounts of nucleic acids that are available in the circulating blood. You think about breast, you think about bladder, you think about prostate and other cancers. And we believe that there will be a medical need and a medical opportunity to differentiate. We are making progress.
We announced last year a number of collaborations with MD Anderson, with Memorial Sloan Kettering recently, a large collaboration to work on a cohort of 1,000-plus patients across 12 cancers, with a Japanese collaborator. We're looking forward to sharing some results coming up at ASCO in a few weeks, and then starting pharma partnership work within this year. We will have an early product in the first phase available at the end of 2025, the broader commercial launch in 2026. Now, transitioning to the right-hand side of this slide, we're also excited about Women's Health, you know, our expanded carrier screening product, FirstGene, Foresight, pardon me. We are anticipating the ACOG guideline update. We're ready for that.
We have a product which will expand from 176 genes to more than 250 genes, which will address all the newly updated ACOG genes that are coming out. We're looking to launch that within the next quarter. FirstGene is going to be a novel and differentiated assay which will bring together both NIPS, non-invasive prenatal screening, with expanded carrier screening to really add value to the provider, to the patient. In many cases, the father isn't available, as well as improved economics for us to drive, you know, both access and better margin. Really quickly again, the FDA announced just a couple of weeks ago updated regulation, the new rule related to LDTs. What I tell you is we are very well-positioned based on our deep experience with the FDA. We have two on-market FDA-approved tests.
We have a strong quality management system experience with our regulatory and quality organizations. Every single test that we have on market is CAP, CLIA, and New York State approved. It's not without work that lies ahead, and it's early days. We believe we're very well-positioned to serve the market and differentiated from many labs based on the experience and capabilities that we have here. A quick recap of first quarter, as you, as you've heard me say, 12% revenue growth while at the same time decreasing our operating expenses in a deliberate fashion, by 4%. Based on the strong results in Q1, we have recently reiterated our guidance for the full year.
As you can see, $820-$840 on the revenue side, which is 9%-11% growth, while at the same time, in a very disciplined fashion, growing our operating expenses, at half, about half that rate for the full year, delivering adjusted positive EBITDA as well as adjusted positive EPS. To summarize, for Myriad Genetics, we are very excited about the road ahead. We feel like we're serving attractive markets that have a profile of growth, as well as opportunity based on our products for us to serve. We have new products which will allow us to not only participate but to take share, enter into new areas.
Based on the combination of our experience, of our portfolio, and our focus on disciplined execution, we look forward to our journey and being a billion-dollar revenue company, in 2026, while delivering adjusted profitability, EBITDA, and cash flow starting at the end of this year. Thank you very much.