AYTU BioPharma, Inc. Common Stock Lytham Partners Fall 2026 Investor Conference
Review the key takeaways and the transcript of this earnings call.
Transcript
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All right. Hello, everyone, and thank you all for joining us during the Litham Partners Fall 2026 Investor Conference. Again, my name is Robert Blum, Managing Partner here at Litham Partners, and up next, Josh Disbrow, Chief Executive Officer; and Ryan Selhorn, Chief Financial Officer at Aytu BioPharma. We'll be taking us through the company's slide presentation. As a reminder, Aytu trades under the ticker symbol AYTU on the NASDAQ. Josh, Ryan, thanks so much for participation today. The floor is all yours.
Thank you, Robert. Great to be here, and great to be speaking with some investors today. If you're hearing this story for the first time, you're certainly hearing this story about Aytu at a really important and exciting time as we just released last week some exciting results for our full-year fiscal 26 and our fiscal fourth quarter, which we'll talk about here in a little bit at Aytu. We say we make medicines made for life, and we take that very seriously and have a portfolio of really important medications inclusive of a new antidepressant called Exua that we've recently launched and which is doing really well in the market. Just as a reminder, we may be making some forward-looking statements, and we may reference some non-GAAP information during the course of our presentation here. As I mentioned, we've got a portfolio of commercial products. We are a commercial-stage specialty pharmaceutical company. We specifically focus on commercializing differentiated brands in central nervous system conditions, and those brands are highlighted by Exua, which again is an antidepressant that we've recently launched and is really a first-in-class medication that stands apart from any other treatment on the market. And again, we'll talk about it.
We also have a base business that consists of some mature ADHD brands called Adzenis and Cotempla, and then a line of pediatric products. And these products all in, over the last 12 months, when you look at the 12 months ending June 30, think of that as about a 57, 58 million dollar portfolio of products highlighted by the ADHD brands. The ADHD brands have been de-emphasized in favor of Exua, which we've recently launched, as I said, and so you can see some of the decline there. That's attributable to both that lack of focus as well as one of the products, Adzenis, does have a generic competitor, which has been on the market for actually quite a while now, yet that competitor has only generated about 20% market share. So products are actually still holding on, still relatively sticky and will really continue, we think, to provide a really solid foundation as we drive growth of Exua and get the company to profitability and cash flow. And some of that stickiness is really attributable to a program that we've developed in-house that's called Aytu Arx Connect, and this is a second-to-none in-house developation access program that enables patients seamless and simple and easy access to our medications.
We put all of our medications on this platform, and when physicians prescribe our products, they'll typically send it to one of our preferred pharmacy partners, typically an independent pharmacy in their local area, and those pharmacies really take it from there to enable a seamless transaction and a guaranteed copay to, in the case of Exua, never exceed $50, which is also the case for our ADHD medications. So it's a program and a process that really enables stickiness and enables longevity. Patients come back month after month after month. These pharmacies are great at running prior authorizations. They're really good at hand-holding and really running through the process that insurance companies today require when getting branded medications prescribed and ultimately dispensed. So it provides patients and prescribers a light, predictable, hassle-free, and affordable access to all of our medications, and this is a program that, again, we've developed in-house from scratch; it's got a lot of bells and whistles, it's heavily backended through a data analytics platform, and ultimately we are provided with fantastic insights down to the prescription level to see pricing, to see reimbursement, and a host of other things to really give us great insight into the profitability profile of each of our prescriptions and, of course, we're able to follow on a de-identified basis patient demographics to understand refill rates and stickiness and for sure these patients are ultimately significantly more sticky when coming into the program and utilizing one of our pharmacies versus just a regular way retail pharmacy.
And physicians love it because it makes their lives easy and they can actually prescribe a brand and not have to worry about some of the dreaded hassles, including callbacks and so forth and so on. And so this is really some of the secret sauce that has enabled the success of both our legacy products, as well as our newly launched product Exua. To complement that infrastructure, we've got a full commercial infrastructure, inclusive of about 40 territories around the country. We've recently undergone a small expansion such that we've now crept out a little bit west and have put territories in Colorado and Arizona and an additional territory or two in California. And so we're sort of making our way to a nationwide geographic spread and really are covering the waterfront. We cover a significant chunk of the depression market now, given the fact that that's our focus and our chief commercial effort. And so but we have a unique element in that we work with a contract sales organization and we're able to essentially try before we buy and we have sort of a rolling rollout with reps that come on through a contract sales organization and as those reps get up to speed and begin to get some success, we have the option, not the requirement, but the option to bring those reps on as full-time W2/A2 employees.
And we've done that already with our first tranche. We're looking at our second tranche of reps and have really had good success evaluating these reps and again kind of a rent or try before you buy scenario and some of these reps in real time have come on board and become some of our higher performing in-house reps. And so we intend to do that. It's a great way to cut the risk, minimize the expense, and ultimately identify the very best reps before you bring them on board on a full-time basis as an A2 employee. So now really moving to, you know, what is and will continue to be the centerpiece of our commercial efforts, and that's Exua. And it truly is an entirely new way to treat major depressive disorder. It's a first-in-class product; it is not a selective serotonin reuptake inhibitor, so it's not an SSRI like Lexapro or like Prozac. It is what's called a 5-HT1A agonist. So it does truly stand alone in that it is a first and only 5-HT1 agonist ever approved for the treatment of major depressive disorder or depression. It's got strong efficacy in multiple clinical studies inclusive of, of course, two phase three pivotal studies done with hundreds of patients each and thousands of patients studied over the course of the development of this product over many years.
It's ultimately a product that works differently than anything else on the market. It does not broadly inhibit serotonin reuptake. It activates a single serotonin receptor, the 5-HT1A or more simply the 1A. And by virtue of only targeting that 1A receptor, an agonizing it both presynaptically and postsynaptically, it turns on the key mood centers in the brain, without having any of the off-target effects. And most notably, it does not cause any sexual side effects, and it does not cause any statistically significant weight gain. Those are two of the most problematic side effects associated with antidepressants today, and the fact that Exua causes neither really makes it stand apart. So it's this novel mechanism of action that really has gotten physicians and patients excited about having something new for the first time in many years, and something that really does work differently. Importantly, this is a huge market. 22 billion dollars, 21 million patients annually, almost 350 million prescriptions of antidepressants prescribed in the US alone every single year. So it's a big market. It continues to grow. And this is a product that's patented through at least 2030 with the opportunity for additional indications and additional IP.
And really, really unique in this market, a handful of markets in the US really have mandated coverage from the government through the Medicare Modernization Act. So patients that are treated for major depressive disorder, essentially have open access on government plans. So that's Medicaid, Medicare, Tricare, et cetera. And that's a significant chunk of this market, 30 to 40 percent of the depression market is covered by government payer plans. And so that has an opportunity to really help us and be what we call gross tenets or our net selling price so when you think about the opportunity from a commercial perspective, if you lay side by side our ADHD portfolio with this product Exua, you're talking about pricing power five to seven times higher in this category specifically with Exua. So really a unique opportunity from a commercial perspective. And by the way, we are seeing that reimbursement come in very, very strong. We're seeing approval rates on both the commercial and the government side come in well. And so a lot of positive things to talk about with respect to Exua. And most notably, the fact that when you're talking about a product like this, it's not a product that treats small niche of patients.
When patients are interviewed and when you look at clinical studies, up to 72 percent of patients complain of treatment emergent sexual side effects. That means sexual side effects or sexual dysfunction caused by their antidepressant and that's a huge number. Within the top five of almost every psychiatrist list of issues with the SSRIs, sexual dysfunction is in that top five. As is weight gain and 65 percent of patients will complain of weight gain and that's seen broadly across multiple studies. There's also a component of anxiety that accompanies depression. And because of this unique mechanism of action, again, it agonizes or upregulates the 5-HT1A serotonin receptor that also has impact on relieving anxiety symptoms. In fact, the only other 5-HT1A approved by the FDA historically is an anti-anxiety agent, but it never demonstrated efficacy in major depressive disorder. So when we bring this mechanism of action up with psychiatrists all over the country, they very often get the connection that, okay, I see that it's indicated for major depressive disorder, but why wouldn't it also hit some of the anxiety symptoms as well? And the answer is it does when you look at those subscales and when you look at standalone anxiety as well.
So really important that you potentially get a one-two punch with this product that again, it's indicated for MDD in adults, but has some impact elsewhere most notably on some of the anxiety components of the disease. Clearly, this product had to demonstrate efficacy. As was seen in two randomized placebo-controlled studies, conducted all over the United States at some major centers. These studies were actually conducted many years ago. But it's important to note that you get early separation from placebo. You see within really two weeks of initiation and really one week post-titration, initiation, you are getting substantial reduction in major depressive disorder symptoms. And that's obviously sustained throughout the full three-week study. And so really important to see. Importantly as well, when you look at the anxiety components, you see separation even earlier at about one week which is essentially as titration is still underway. And so you're getting great benefit with respect to symptomatic improvement and you're getting it relatively quickly, which is something that physicians don't necessarily expect in the context of major depressive disorder treatments. And again, very important that this is the only product in the category that does not carry a warning around the risk of sexual dysfunction and demonstrates no significant weight gain.
And so that's really important. And a very good tolerability profile with only 7 percent of patients discontinuing treatments. And when you look at things that are noteworthy in the PI, like nausea, and dizziness, a very, very small percentage withdrew from the studies as a result of those. So really not problematic, demonstrating that they're very mild and transient in nature, which is exactly what we're seeing in the real world. So that's really important. So to sum up, Exua, it's got a very clear profile, a very clear position in the market and very clear differentiation in that it's truly one of the only products out there that's novel again, it's not an SSRI, it doesn't bathe the brain in serotonin. And numb the body. Again, no impact on sexual function, weight neutral, once daily dosing, which is favorable to one of the competitors that's recently launched over the last few years called Auvelity. And so it really does stand apart, has a really nice market position, and we're really seeing the evidence of that as we look at prescriptions as well as factory shipments. Both of these are important because we base our revenue off of shipments.
And so it's important that we note those to lead investors to a more logical conclusion in terms of what potential revenue is. But really what we look at on a day-to-day basis is underlying demand, which is prescription demand. And you can see since launching the product in mid to late December, really, really nice trajectory and a nice uptick here in August, which really tends to be a slow month as we sort of enter the dog days of summer. And I will say we're really looking at a nice September with prescriptions almost reaching 400 prescriptions for the week ending September the 4th. So as we're speaking here today, some of the most recent data that we've seen demonstrating an even continued climb. And that's really been with some reoptimation of our reoptimization of our Salesforce with which we spoke to on our earnings call last week. Real quickly before I hand it to Ryan, also have a legacy portfolio. These are products that have been stable, relatively speaking, and really think can continue to really drive significant revenue and support the business as we launch and grow Exua. You can see even with us pulling promotion of the entire portfolio, particularly on the ADHD side, have remained relatively stable.
Yes, prescriptions are down, but really demonstrating the stickiness of that is afforded by the RxConnect platform. And so it's something that excites us to know that both TRXs are hanging on relatively speaking and pricing actually has held on very, very well. So with that, let me hand it over to Ryan and we can wrap things up. Ryan? Thanks, Josh. Returning to our financial performance, fiscal 2026, net revenue is approximately $57.6 million, reflecting our contributions from our established ADHD and pediatric portfolios as well as the initial launch of Exua.
While revenue was lower than prior years as we navigated generic competition in ADHD and invested in the Exua launch, we believe these investments positioned the company for future growth. On the profitability side, adjusted EBITDA was a loss of 3.7 million in fiscal 2026. So importantly, this results reflects deliberate investments in the commercialization of Exua including Salesforce expansion, market access initiatives, promotional activities designed to establish the brand, in the large and growing MDD market. As we move forward, our objective is to leverage our existing commercial infrastructure that drive the continued Exua prescription growth and improve operating leverage across the organization. We believe the combination of a growing Exua franchise and a disciplined expense management creates a compelling path towards enhanced financial performance over time. Looking at our balance sheet, we ended fiscal 2026 with $26.3 million in cash and cash equivalents. And $61.8 million in total current assets. Our total liabilities were approximately $69.7 million, including $17 million of borrowings comprised of our term debt, which is amortized monthly, and revolving credit facility with availability of up to $14 million.
Overall, we believe our balance sheet provides the resources necessary to support the continued commercial expansion of Exua while maintaining financial flexibility and disciplined capital allocation. Our focus remains on maximizing the value of our existing portfolio, driving Exua growth, and creating long-term value for shareholders. I'd like to thank everyone for their interest in A2. And at this time, I turn it back over to Robert.
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