All right, perfect. Sounds good. Thanks, everyone, for joining us here at the Microcap Rodeo. My name is Robert Blum, handling investor relations with Aytu BioPharma, and with us is Ryan Selhorn, the Chief Financial Officer. We're going to do this in a little bit of a fireside chat style event here, so I'm going to throw some questions over to Ryan here, and we'll leave a little bit of time at the end if there's any questions from the audience. Ryan, thanks so much for participating here. Let's start off. Aytu BioPharma trades on the Nasdaq, ticker symbol AYTU. For those not familiar, provide everyone with a high-level overview of the company if you could.
Yeah, absolutely. Thanks for having me. So, the business started in 2015 by Josh Disbrow and his twin brother, Jarrett Disbrow, as a specialty pharmaceutical company. They had previously exited successfully another company called Arbor Pharmaceuticals, sold for about $1 billion, and decided to try to do it again. So, we are a commercial pharma business that specializes in ADHD and pediatric products. We are about a $66 million product, with about $58 million of that representing our ADHD business. And one of the key differentiators of our business, not only do we have 40 sales reps, but we also have a program called A2Rx Connect. And how this works is there's a big disconnect between doctors, payers, pharmacies, and manufacturers in kind of who gets incentivized from a compensation standpoint.
We have kind of streamlined that to partner with 1,000 pharmacies to ensure patients get access to our prescriptions and don't have to pay an exorbitant amount of a deductible. We partner with them to ensure that the prescription goes through and that they're paying no more than $50. In addition, the pharmacy will profit as well, typically about a $20-$25 profit when these prescriptions are not covered. This is our core business. We are about a $9 million EBITDA business, just about cash flow break-even, maybe slightly above that on a quarterly basis. The real excitement of our business happened in June when we decided to license a new product in the major depressive disorder space, MDD, called Exxua, that we were excited about.
We just raised $15 million to help with that launch of the product that will happen later this year.
Yeah, let's, as you mentioned, exciting new opportunity here for Exxua. For those maybe not familiar with it, describe what the product is utilized for.
Yep, absolutely. So, Exxua is a novel, first-in-class treatment for major depressive disorder. If you're not familiar with the depression market, about a $22 billion market. And most of it is served, about 60% of it is served with SSRIs or SNRIs, which are more common names like Prozac, Zoloft, Lexapro, Cymbalta. We are different in that the SSRIs and SNRIs focus on all different receptors within the brain. This new product, Exxua, is a new class of treatment that focuses on the 5-HT1A receptor alone. And this receptor is associated with mood. One of the biggest challenges that the depression market has are the side effects of the drugs on the market today. So, most products out on the market today have sexual dysfunction associated with them and weight change, specifically weight gain, and very specific to the SSRIs.
The Exxua product that we're about to launch does not have either one of those side effects. There's nothing written on the label or in the PI that would indicate that there's any sexual dysfunction or weight change. In fact, Exxua, in some of the trials that we've done, actually improves the sexual function and desire in patients. While this is not an approved claim, the data is peer-reviewed, and there are publications that we can point to in the public domain, so we plan to do so so that clinicians can understand the difference between our product and what's on the market.
Talk a little bit more about the market. You talked about the SSRIs, SNRIs, some of the products that are out there, but there's a number of recent products that have launched as well. Characterize, maybe in general, the MDD market and some of the companies that are in it right now?
Absolutely. So, as I mentioned, the market is about a $22 billion market. There are 340 million prescriptions of depression medication annually just in the United States. And these SSRIs and SNRIs represent about 60% of those prescriptions. So, there's literally a prescription for every person in the United States, plus some leftover. The market itself is fairly genericized with the brands that I mentioned earlier. But there are a few new brands that have come out recently and have had significant success in the past few years. These are Trintellix by Takeda Pharmaceuticals, Auvelity by Axsome, and Spravato by J&J. They've seen great side effects, sorry, they've seen great growth from a revenue standpoint, but all three of them all have the same side effects that I referenced earlier from a sexual dysfunction and a weight gain standpoint.
And even, in fact, Trintellix, they have about two million prescriptions last year, and their sexual side effects are in the range of 29%-34%. So, that's pretty high for this type of drug. Additionally, Auvelity dosed twice daily. And so, our drug only has is once daily done typically in the evenings with food. So, from a consumer compliance standpoint, we think we'll have some success there as well.
Now, let's talk about the upcoming launch, right? So, you acquired the rights to this in June. You're getting ready to launch here by the end of the calendar year, so the end of December 2025 here. Talk about some of the activities that are going into the preparation for launch here.
Yep. Yeah, and so, just to be clear, so Exxua is an FDA-approved product at this point. So, we're just working on finalizing the product manufacturing, packaging, validation, labeling, sterilization, and then getting it to our third-party logistics provider, all which takes some time. So, following this June license agreement being finalized, we're anticipating that we'll be able to get product to the wholesalers by November or December of this year. In addition, we brought on Dr. Gerwin Westfield as a senior vice president of our scientific affairs. We haven't had a scientific affairs individual previously in the recent time under our ADHD. But Dr. Westfield actually was employed by Aytu just during the pandemic and slightly thereafter. So, what we're glad to welcome him back is he's a big leader in the field. He contributed to a Nobel Prize, and he's working on peer-reviewed publications, key opinion leader engagement.
We're really excited about the feedback that he's already received from the general public on this. Additionally, we plan to and are in the process of redefining our sales territories from an alignment and physician perspective. We will call on primarily psychiatrists. The benefit is we currently call on about 60% of the same psychiatrists across the market that this depression drug will focus on. There won't be a significant amount of change, but definitely a focus on key areas in psychiatry. Additionally, government payers, one area that is little known, is that government payers are required by law to cover depression. There are six protected classes under Medicaid and Medicare, and depression is one of them. We're anticipating, and what we see from our competitors is that 30%-40% of the market will go through government payers.
And with that, we are holding off negotiating with commercial payers at the moment until we can see what the impact would be. Some of our competitors haven't negotiated or only have one contract with commercial payers. It does look promising from a gross-to-net standpoint. Other than that, we're working on branding, promotional aspect, engaging with consultants on our materials, and making sure that we have a clear message to clinicians and psychiatrists on what our product can do and how it's differentiated in the market.
Let's transition here to ADHD just for a moment. Again, sort of a base business that you've been operating there for a number of years very successfully. There's a well-known patent or settlement out there that you've talked about in detail most recently at your earnings call here yesterday.
That was yesterday.
Talk a little bit about why you believe the impact from the entry there is maybe not as much as what might be in similar situations.
Yep, absolutely. Yeah. So, just to be clear, Teva has activated the ANDA in the Orange Book, which is an indicator that they are planning to come to market with a competing product, a generic version of our product. But yeah, there are probably three, maybe four reasons why we don't think that their impact will be as large as other generic entrants in other products. First off, we did just launch our own generic on September 2nd. So, we are now in the market with both a branded product and a generic product and have seen good response to our generic product as well. So, that should help mitigate some of the competition with pharmacies and with payers. And as of right now, just to be clear, Teva hasn't entered the market from a commercialization standpoint.
We believe that they will in the coming months, but we aren't sure what that timing looks like. One of the main reasons that we're comfortable with kind of how we sell is due to this Rx Connect program that I referenced earlier. Rx Connect is basically 1,000 pharmacies that we've negotiated with that we work hand in hand with to make sure that they are compensated appropriately, to make sure that the patient receives the prescription that was prescribed and that the patient is not paying an exorbitant rate.
One of the issues that doctors face today is when they prescribe medication. A lot of times these patients will come back after visiting their pharmacy saying, "This wasn't covered under my insurance," or, "I need to pay $300, $400 for it, and that's too much." Doctors are burdened with this effort to have to go back and represcribe, or there needs to be a prior authorization that they need to fill out forms. We've cut out all of those pieces. If a prescription is not covered, we have a mechanism with our pharmacy in this agreement where we will reduce the price to the patient to make sure that they currently pay no more than $50.
Additionally, a lot of times pharmacies are underwater with a lot of these drugs that aren't covered, and we ensure that they will have a profit on our product. So, the pharmacy is encouraged to fulfill the prescription. The doctor is encouraged that when they prescribe the ADHD medication that it won't come back to them with a complaining customer, and we get the sale of the prescription. So, this is not something that we believe Teva will typically go to your big box stores of CVS and Walgreens. And only about 15% of our prescriptions come from there.
All right. I want to just in the interest of some time here, let's come back to Exxua here. Surveys, Josh Disbrow, the Chief Executive Officer, his experience all seems to indicate the opportunity for extremely strong adoption. For those that maybe didn't hear the earnings call yesterday, can you share a little bit of the real-world narrative that's out there? Maybe share with everyone here some of the surveys that have been conducted by some of the investment analysts and others out there as well.
Yep. So, just for some background, so Josh started his career as a pharmaceutical sales rep. So, he's very familiar with discussing with practitioners on new medication. So, he spent two full days in Houston, one of our territories, traveling around with one of our sales reps and met with 20 different psychiatrists just to get a flavor for their reaction to a new drug on the market, their challenges with the market, and how they prescribe. And all 20 of them focused the conversation on the fact that all of their drugs have sexual dysfunction impacts and the weight gain, and that's the biggest complaint that they get from their customers. And they don't have an alternative solution for that.
So, when they did hear that our drug has neither one on the package insert, they were ecstatic about it and immediately said that they had at least one or two patients right out of the gate that they would prescribe and change just for those factors alone. So, a lot of excitement with the psychiatrists. They all said that they would prescribe it and were looking forward to the launch, actually wanted to start prescribing it right away. And so, this kind of reconfirmed another independent research market research process that we went through with a third party where they did something similar with another 20 psychiatrists and asked them about their receptiveness to a new product, and especially one without sexual dysfunction and weight gain, and got a resounding yes, we would definitely prescribe.
And thirdly, Lake Street, a bank that we did our last capital raise with and does our research. Our research analyst is a research analyst for us now. They independently reached out to another group of 20 psychiatrists and did a 10-question survey about the market and the challenges of it. And we got similar responses across the board that they would all be willing to prescribe, and we're excited about it. So, the reception has been tremendous. Everyone is looking forward to this new product on the market in the next six to nine months.
All right. Let's advance here just a little bit. Walk us through the modeling, if we could, here for Exxua, right? You sort of product launch coming up here at the end of this calendar year. Walk us through some of the expectations here throughout the rest of this year and what people should be looking for.
Yep. So, how it typically works is we plan to launch officially in November or December of this year, this calendar year. And that will primarily be just what we call load-in, where we'll be selling to distributors and wholesalers. So, there won't be much revenue in the next upcoming quarter. Then, the first calendar quarter of 2026, our sales reps will be trained up and will be out on the market pitching to all the psychiatrists about this product and introducing it to the market. We may see some prescription level, but usually there is about a quarter of that it takes to kind of get them to understand the product and understand how to prescribe it. So, it's really not until the June quarter, second calendar quarter, that we'll start seeing some real kind of meaningful revenue going forward.
That's the expectation, and that will help us to understand what the trajectory of this product really could be. From a cost standpoint, gross margins on Exxua will be about 67%-68%. Most of it is related to a royalty that is part of the license agreement. And then we do have an upfront fee that we did pay of about $3 million. We paid that back in June. We'll pay another $3 million a year from launch date. And then we do have milestones that start at $100 million and go up from there. So, then all of those fees will be considered an intangible asset and just amortized over the life of the drug.
Additionally, we'll spend about another $10 million of operating expenses to help get this launched, which about $6 million or $7 million of that are one-time costs with consultants as we get our marketing materials up and running, and then a little bit on kind of people. Like I said, we hire a new VP of scientific affairs, and we'll have a handful of additional sales reps.
A couple of minutes left here. You just reported fiscal year 2025 results, meaning you guys have a June year-end. Maybe those that didn't get a chance to look at them, maybe give us a high-level overview of the quarter.
Yep, so for the year, we did $66.4 million in revenue, which is a slight increase from our previous year. Adjusted EBITDA is about $9.2 million. This is our third year in a row that we have positive adjusted EBITDA. A lot of changes in the business over the last two years. Our OpEx has decreased significantly. As I may have mentioned, we were in a number of different businesses, including a consumer health business. We had a development-stage asset. We were manufacturing our own product. All of that is now gone. We've divested it or shut that down in 2024, and so the last two quarters are kind of more indicative from an operating expense standpoint of where we'll be. From a cash flow burn standpoint, from an operation standpoint, we burned about $2 million of cash. We were cash flow positive in the fourth quarter.
We think we're on a good trajectory with the base business with the ADHD and the pediatric portfolio to now layer in this new product with Exxua and go from there.
All right, and maybe in the final couple of minutes here, balance sheet.
Oh, yes, so cash-wise, as of June 30th, we were sitting at $31 million in cash. We had $18 million in cash as of March. As I mentioned, we did raise $16 million gross or just under $15 million net in June. That raise was led by Nantahala Capital and Stonepine Capital and a handful of new healthcare investors, so we do have a number of institutional investors that are very long in this business. To the extent of fully diluted, they represent just over 60% of our stock, and they are not selling. They believe in this new product and are excited about it. Additionally, we topped off our loan.
We had a term loan of about $11 million that we moved back up to $13 million, really used those proceeds to pay off some fixed payment arrangement that was high-interest debt that we needed to get off the balance sheet. So, overall, our balance sheet is looking a lot cleaner today than it did just a year or two ago, and we're poised for this new launch.
Final takeaways here for investors.
Yeah. I think the next year, we're kind of heads down with this new launch and trying to get this thing off the ground running. I think, unfortunately, it won't be until the June quarter that you really kind of see what this product can do. But I think once we get started with it, it's very easy to do the math that this could very quickly be a $50 million business, Exxua alone, in a year from now. Well, we don't actually guide, but when you do the math of the number of prescriptions out there and the opportunity with the lack of side effects, we're very excited. The entire team is excited to grow this.
Did I hear a question? Was it a question, Jeff? Go ahead.
Yeah. It ranges. Like I mentioned, Trintellix has about a 30% rate of sexual dysfunction. Some of the SSRIs are lower. They're kind of in the 10% range. So, it may not sound like a big number, but when you're talking about 300 million prescriptions, it adds up pretty quickly.
Yes.
When the major drugs were made, they actually increased the feeling, and they numb up the genitals. Some people can't even feel it. I mean, that woman that said that she had a lockdown there, and then the guy said that she had all these feelings, it's not even a matter of erectile dysfunction. It literally makes them numb. I'm not sure why. I don't think they actually know why. But it really puts down the sexual feeling, and you can't really measure. I think it's probably more than $50 million.
Yes.
Yeah. I mean, that obviously is our hope. Yeah. I think a lot of these have, they go after a number of neurotransmitters to try to implicate the mood piece of it, where this one is just going after the one 5-HT1A transmitter that you could look up that is focused on mood. So, we think that that's the differentiator from a sexual standpoint and the weight gain. But you're absolutely right. Every psychiatrist that we talk to says that's the biggest complaint, and patients, they would much rather not have the sexual effects and still be depressed and get off the pill than the alternative. So, that's kind of the excitement here.
All right, well, go ahead, Jeff, one more.
Yeah. So, we licensed it from a company called Fabre-Kramer. They're essentially two individuals that are running the business. It has a long history. It's been going through in and out of trials for the past 20-plus years and passed hands with Merck and a number of different players in and out. They got it approved in 2023. Some of the hair on it, which isn't really a big deal to us, is it only has a five-year runway from a patent standpoint. So, the patents will expire late 2030 or early 2031. So, the bigger players in our market aren't interested in something that short. So, that's probably the biggest piece of it.
Now, we are working hard to already figure out how we can tweak the drug to extend the patent life, and we're talking with different companies about that. So, I think hopefully we can kind of figure out a way to extend the patents for a number of years, assuming that it is as successful as we think it will be.
All right. Thank you, everyone. Thank you very much, Ryan. Appreciate your time.
Excellent. Thank you, everyone.