Aytu BioPharma, Inc. (AYTU) Q1 2026 Earnings Report, Transcript and Summary

Greetings. Welcome to the Aytu BioPharma Fiscal 2026 Q1 Earnings Call. [Operator Instructions] Please note, this conference is being recorded. I will now turn the conference over to your host, Robert Blum with Investor Relations. You may begin.

All right. Thank you very much, and good afternoon, everyone. As the operator indicated during today's call, we will be discussing Aytu Biopharma's fiscal 2026 first quarter operational and financial results for the period ended September 30, 2025. Joining us on today's call is Aytu's Chief Executive Officer, Josh Disbrow; and Ryan Selhorn, the company's Chief Financial Officer. At the conclusion of today's prepared remarks, we'll open the call for a question-and-answer session. I'd like to remind everyone that today's call is being recorded. A replay of today's call will be available by using the telephone numbers and conference ID provided in the press release issued earlier today or by utilizing the link on the company's website under Events and Presentations. Finally, I'd also like to call to your attention the customary safe harbor disclosure regarding forward-looking information. The conference call today will contain certain forward-looking statements, including statements regarding the goals, strategies, beliefs, expectations and future potential operating results of Aytu Biopharma. Although management believes these statements are reasonable based on estimates, assumptions and projections as of today, these statements are not guarantees of future performance. Time-sensitive information may no longer be accurate at the time of any telephonic or webcast replay. Actual results may differ materially as a result of risks, uncertainties and other factors, including, but not limited to, the factors set forth in the company's filings with the SEC. Aytu undertakes no obligation to update or revise any of these forward-looking statements. With that said, let me turn the call over to Josh Disbrow, Chief Executive Officer of Aytu Biopharma. Josh, please proceed.

Thank you, Robert, and welcome, everyone. I'm excited to be speaking with you on the heels of a very positive and highly productive first quarter. Let's jump into the high-level highlights. First off, net revenue for the quarter was $13.9 million. This was above our expectations as our ADHD portfolio has really continued to perform well. In fact, the ADHD portfolio net revenue was essentially up 10% compared to the year ago period when excluding the onetime commercial rebate benefit we received a year ago. ADHD revenue was also up on a sequential basis. At a time when investors perhaps had expected a pullback in ADHD sales due to the threat of a generic launch and our shifting focus to EXXUA launch preparations, we are actually experiencing net revenue growth. This is quite impressive and really reinforces our long-held belief on the added stickiness and positive economic benefits that are inherent in our Aytu RxConnect platform through which I'll remind you, approximately 85% of our branded ADHD prescriptions are dispensed. I'll dive into this more in a moment. But first and perhaps even more important is that the EXXUA launch remains on track to occur by the end of calendar '25. With significant advancements being made to ensure success, including KOL engagement, sales force training, product positioning, messaging, campaign development and pricing, payer assessments and integration within RxConnect. We continue to believe EXXUA is a game-changing opportunity for Aytu and the past few months have really reinforced that belief. Let's dive into our EXXUA launch execution initiatives in more detail. First off, we're finalizing product manufacturing, labeling, serialization and shipment to the company's third-party logistics provider with the initial shipments on track for delivery in December of '25. In many ways, this has been the biggest gating item to launch and it remains on track. We are nearing completion of sales force training and have our formal launch meeting scheduled to take place in January of '26. That said, leading up to the launch meeting, our reps are and will continue to be in the field talking with and preparing physicians and setting up appointments, et cetera, with the full sales force launching products stocking, following launch stocking and the launch meeting. The product positioning, preparation of the promotional campaign, inclusive of promotional materials, refinement of physician messaging and development of patient support materials is also nearing completion. We are implementing a comprehensive promotional program, whereby we're establishing a clear positioning for EXXUA based on its attributes, the competitive landscape and ultimately where we believe we can win with the product. We have completed refinement of the sales territory alignments with physician targeting also essentially complete. We are maintaining a sales force of approximately 40 people, the same as what we have had historically with ADHD, but have altered some territories to ensure maximum reach while also aligning with where market access is expected to be strongest and prescribing potential is expected to be the highest. Remember, for government payers, major depressive disorder has nearly universal coverage as this condition is a federally mandated protected class, whereby MDD prescriptions must be covered. This government segment represents approximately 30% to 40% of MDD covered lives depending on the geography. So with the 30% to 40% of the antidepressant category covered by virtue of this protected status, we are aligning sales territories appropriately to ensure optimal patient access with respect to both government and commercial payers. Further to that point, we've also established product pricing that is in line with or at a premium to other unique psychiatric treatments. We are also finalizing integration of EXXUA into our Aytu RxConnect patient access platform. We expect to drive distribution through and dispensing from our RxConnect network pharmacies as we do now with our ADHD portfolio. This will enable us to gain strong insights on reimbursement and coverage rates to help guide selective and smart payer contracting, which we will consider as the product launch gets underway. Employing RxConnect will also help ensure minimal friction with new prescribers of EXXUA as it relates to coverage and the typical barriers they face when prescribing new brands. And the final key launch activity has been the ramp-up in our key opinion leader engagement. EXXUA has a long history of peer-reviewed publications. And that was added to recently by yet another peer-reviewed article discussing gepirone and the class of 5HT1 agonists. Further, we recently attended our first medical conference, the Neuroscience Education Institute Fall conference in Colorado Springs. The response to EXXUA was tremendous. Led by our Senior Vice President of Scientific Affairs, Dr. Gerwin Westfield, we will continue to be proactive in our broader education of EXXUA to the medical community and engagement with the scientific community. Finally, as most of you likely saw, we were successful in getting the EXXUA method of use patent for EXXUAs extended to September of 2030. The patent extension further expands upon the new chemical entity exclusivity period. Beyond the 2030 date, we are engaged in discussions to expand upon the existing intellectual property through various potential life cycle management approaches, which might extend exclusivity beyond 2030. This is all to say we are laser-focused on the successful commercial launch of EXXUA as we focus on positively impacting the lives of an estimated 21 million Americans with major depressive disorder. Our entire team is beyond thrilled as we collectively believe EXXUA is quite simply transformational for Aytu. Turning back quickly to the ADHD portfolio. As most of you know, there has been a long since negotiated Paragraph IV settlement agreement with Teva, whereby they were allowed to enter the market with a generic to Adzenys back on September 1. As we sit here today on November 13, more than 2 months after they were eligible to have entered, they have yet to launch. We talked about this during our last earnings call. But to quickly summarize, it's been our long-standing belief that the impact to our ADHD franchise, even if Teva does enter, will not be as significant as you might see with other products sold via traditional retail distribution. The reasons for this are multifold, but include: one, the fact that, again, approximately 85% of our ADHD prescriptions run through our RxConnect platform, not through regular way retail like CVS or Walgreens. This system is quite unique and dramatically alters the normal way in which generics might try to compete on pricing and spread. Two, the ADHD category is already a highly genericized market with minimal switching. Opportunities have existed for many years to prescribe and fill alternatives like generic Adderall XR, yet we've held a consistent share of the market for multiple years. Third, the gross to nets on our ADHD portfolio are already below what industry observers might expect when generics typically enter the market. Price erosion has already largely occurred by virtue of the fact that we discount significantly to overcome patient pricing objections in a highly genericized market. This is to say that the substitution impact and transition to a generic price -- a generic market and subsequently to a generic price is not nearly as high as you might see in other situations. And fourth, we launched our own authorized generic of Adzenys on September 2. This AG will serve as an important offensive tool in what we believe will help us maintain a material share of the Adzenys market, irrespective of a potential generic entry by having a truly equivalent version of a product available that is sold as a generic. And importantly, our AG is already off to a very good start, representing a significant share of the prescriptions after just 2 months on the market. We know it's still early. But we continue to believe that anyone's projections of a worst-case scenario for a broader impact to our ADHD franchise are unlikely, but clearly we will continue to monitor things. One more quick note before I turn it over to Ryan to review the financials in more detail. As some of you may have seen, on October 31, the FDA put out a communication regarding their position on fluoride-containing drugs and some potential regulatory action. This has been anticipated for some time. And we've communicated this to you during past calls. We continue to monitor the situation, but note importantly that Aytu has not received any direct communication from the agency seeking action on our fluoride products. Even in the event FDA ultimately pursues any action, it's important to note that this is a very small portion today of our overall business. During the quarter, fluoride products amounted to only about $300,000 in revenue. And importantly, our infant drops product line represents only approximately $1.4 million when looking at the trailing 12-month period ending September 30. So any potential impact will not have a sizable impact on our financials given that any agency action would likely center only on the fluoride liquid drops for the youngest patients. Also importantly, following the FDA's October 31 communications on fluoride supplementation, the American Dental Association issued yet another press release that clearly supports supplementation and the association doubled down and continue with the recommendation to continue with fluoride supplementation in areas where fluorinated water either doesn't exist or has inadequate levels of fluoride. Again, we'll continue to monitor the situation. With that, let me turn the call over to Ryan to go into more detail on the financials. I'll then make a few closing comments and look to address any questions you might have. Ryan?

Thank you, Josh. Let's jump right into it. Let's start on the revenue line. Net revenue for the quarter was $13.9 million compared to $16.6 million for the prior year. As mentioned in the press release, the year ago quarter included a onetime benefit due to an accrued rebate liability settlement related to the ADHD portfolio of $3.3 million, which resulted in an increase in the Q1 fiscal 2025 net revenue of $3.3 million. We highlighted this item last year as well. Excluding the rebate on an apples-to-apples basis, net revenue would have actually increased 5% compared to the year ago quarter. Breaking net revenue down, the ADHD portfolio net revenue was $13.2 million compared to $15.3 million in the prior year period. Excluding the rebate, the year ago quarter would have been $11.9 million, highlighting net revenue increasing for our ADHD portfolio of about 10% on an equivalent basis. The increase is attributable partially to product price increases during the past year and improved gross to net, offset by a decrease in total prescriptions. The pediatric portfolio was $0.7 million for the first quarter compared to $1.3 million last year. The change in net revenue is attributable to manufacturing delays with one of our suppliers, which we are in the process of being resolved as well as multivitamin product returns and a broader deemphasis in marketing toward the pediatric portfolio in anticipation of the recent actions by the administration and the FDA. Gross margin was 66% during the quarter compared to 72% last year. Again, the rebate here flowed entirely through the gross profit line as well. So on an equivalent basis, gross margin during the year ago period would have been 65%. So we actually saw gross margin improvement from the year ago period when excluding the rebate. Turning to OpEx. Operating expenses, excluding amortization of intangible assets and restructuring costs, was $10.2 million in the first quarter compared to $11.2 million in the prior year period. This $10.2 million figure also includes about $100,000 in depreciation and stock compensation. So the cash OpEx number is about $10.1 million. The decrease is primarily a result of continued cost reduction efforts and improved operational efficiencies as part of the company's overall strategic realignment, offset by increased EXXUA launch investments. When you look at the modeling of expenses going forward, we anticipate that our baseline total operating expense level, inclusive of amortization and depreciation, will remain at about that $10 million per quarter. Then added to that, we will have an incremental investment of about $10 million on the launch of EXXUA this fiscal year. So all in, that is about a $50 million OpEx number for the fiscal 2026. Importantly, of the $10 million of EXXUA investment this year, about $6 million of that is sort of onetime items, such as training development, commercial and medical affairs consultants and campaign and marketing materials development. The bulk of this spend will be in our December and March ending quarters from a onetime perspective. Going forward, we will certainly adjust our spend as the ramp of EXXUA continues, but think of our exiting the fiscal year at about $11.4 million quarterly normalized run rate with about $0.5 million of that in noncash expenses. Assuming gross margins in this mid to high 60% range, that puts our breakeven at about $17.3 million of net revenue per quarter all in, including EXXUA spends. Cash breakeven would be $16.6 million per quarter. For the quarter, we reported a net income of $2 million or $0.21 net income per share basic compared to net income of $1.5 million or $0.24 net income per share basic in the prior year period. The fiscal 2026 and fiscal 2025 first quarter results were impacted by derivative warrant liability gains of $3.8 million and $2.9 million respectively, primarily due to a change in the company's stock price. And as mentioned earlier, the prior year first quarter benefited by $3.3 million due to the rebate liability adjustment, which directly increased net income. I'll touch on the warrant liability in a moment. But this is largely due to the prefunded warrants issued in the EXXUA transaction. Finally, adjusted EBITDA was a negative $0.6 million for the first quarter of fiscal 2026 compared to a positive $1.9 million in the year ago period. The change primarily relates to the benefit we received in the year ago period from the rebate as well as EXXUA launch investments, which took place in the first quarter of this year. Now turning to the balance sheet. Cash and cash equivalents were $32.6 million at September 30, 2025. This compares to $31 million at June 30, 2025. A couple of other small notes on the balance sheet. We continue to pay down some higher interest liabilities during the quarter, namely the Tris fixed payment arrangement. You will see that the other current liabilities line went from $3.4 million in June to $0.2 million this quarter. This has resulted in a substantial decrease in interest expense from $1 million in the prior year quarter to $0.5 million in the current year quarter. While we don't anticipate $0.5 million of savings each quarter, we should see continued savings throughout the fiscal 2026. The rest of the balance sheet is pretty much in line with where it was last quarter. Circling back to my comment on the derivative warrant liability gain. As you may recall, the financing transaction we completed in connection with the EXXUA acquisition was basically a straight common stock deal, but it did have prefunded warrants issued due to ownership percentage blockers. This does cause gyrations to the income statement based on the movement of our stock price, which creates gains or losses to the derivative warrant liabilities line each quarter. On the balance sheet, those warrants are treated as liability until they are converted to common shares, at which time they will move to additional paid-in capital. During the quarter, there were 935,000 prefunded warrants exercised, which effectively added $2.1 million to [ APIC ]. As we sit today, there are 10.2 million common shares outstanding, plus an additional 9.4 million prefunded warrants outstanding, which effectively puts us at 19.6 million shares outstanding. Before I turn it back over to Josh, to reconfirm what we communicated last September -- late September during our call at year-end, let me spend a few minutes walking through some of the assumptions we have on EXXUA for the remainder of the year. To be clear, there have been no changes to what we mentioned during the last call. I simply want to make sure anyone that missed it has the information handy. So as discussed, we plan to launch EXXUA in the fourth quarter of calendar 2025, which is our second fiscal quarter of 2026 or the December 2025 ending quarter. This will be the initial product load-in. We would not expect there to be any significant revenue to report during the second fiscal quarter. The launch will continue into the March 2026 quarter where we expect to see some initial ramp in revenue, but the real story is expected to occur during the June 2026 quarter and beyond. From a gross margin perspective, as a reminder, we have a 28% royalty on EXXUA in addition to a true-up on cost of goods sold. Just think of it in essence as a 31% cost of goods sold or 69% gross contribution margin. We do anticipate some fixed expenses to be incurred in cost of goods sold following the launch. However, the upfront fee, post-launch fee and any milestone payments will be reported as an intangible asset and amortized to the operating expenses starting once we launch the product. As I noted earlier, from an OpEx perspective, we expect to invest approximately $10 million in the initial launch of EXXUA here in fiscal 2026. This was well defined in the plans heading into the product acquisition and financing that we conducted. And we expect this puts us in a good cash position as EXXUA begins to ramp as we exit fiscal 2026. As always, happy to go over any details during Q&A. With that, Josh, let me turn it back over to you.

Thanks, Ryan. I want to make sure we leave time for questions. Let me wrap up here quickly and then I'll turn it over to you for questions. Simply put, we are on the cusp of bringing to market what we believe is a game-changing opportunity for major depressive disorder. Every physician survey conducted, whether by us or independently, has shown almost universally that once available, physicians have patients for whom they will prescribe EXXUA due to its effectiveness in treating the symptoms of depression without inducing critical side effects such as sexual dysfunction and weight gain. As I've said in the past, nowhere in the package insert are the words sexual dysfunction mentioned, a claim virtually no other MDD pharmaceutical treatment can make. We think this is critical. Further, EXXUA is weight neutral and doesn't increase anxiety to additional product features we and our survey prescribers view as extremely valuable and also distinct from many other treatment options. And while we think the peak sales for this product are extremely high. The reality is that even if this does a fraction of what many of the competing products in the market do or if we receive just a fraction of the scripts written that our ADHD drugs have, this is a huge opportunity for Aytu and for our shareholders. The coming months are very exciting for Aytu. We're laser-focused on the launch and success of EXXUA and look forward to getting this into the hands of physicians in the months to come. As always, I want to thank everyone participating on today's call. We'll now be happy to answer any questions. Operator?

[Operator Instructions] Your first question for today is from Thomas Flaten with Lake Street Capital.

Congrats on the quarter. Josh, I was wondering if you could comment on how significant or maybe how many territories were affected by the realignment? And then part 2 of that question is, how are you thinking about the incentive comp plan post EXXUA launch?

Yes, good questions. Thank you -- just writing those down. Thanks for those questions, Thomas. How many territories affected? In whole or in part off the top of my head, it's probably no more than about 1/3 of the territories have been maybe altered or reshaped. We have gone denser in some areas where we fully expect substantially better coverage than we have for ADHD meds and actually really favorable coverage. So I think of it as probably about 1/3 in one way, shape or form. Some were modestly affected a few ZIP codes here or there. Others were more materially affected, but probably in that range. In terms of IC very rich IC plan still being finalized. But we will certainly incentivize very, very heavily around EXXUA, activating new psychiatrists, getting new offices set up and then obviously rewarding for going deeper within those prescribers as well. So incentivized to get them turned on and initially utilizing EXXUA and then obviously, incentives to get repeat prescribing as they identify more and more patients. So we will be hyper focused. As we've said in the past, this will be a strict psychiatry play. So we'll be in offices that are housing psychiatrists and psychiatry nurse practitioners and PAs. And that's really where the density of the prescribing for the brands in this category happens. So that's the right place to be.

And then if I may, one more. What have you been doing prelaunch with respect to payer engagement? Is that something you've been doing? And what expectations do you have for coverage improving beyond the kind of protected Medicare component of it?

Yes. Good questions. So for us, first, second and third, around anything related to particularly commercial payers for us is wait and see. We're not going to proactively contract so as to jeopardize best price that we'll have afforded to us on the government side. As you know, with the mandate to cover antidepressants, we'll have, we think, a pretty wide open field, particularly in at least a handful of states. And we'll be able to have access -- open access with the standard 23.1% rebate to the Medicaid plans in particular. So as we think about that and we think about the portion of the business that that is likely to represent, call that 30% to 40% depending on the geography, we want to be very judicious in how we think about contracting on the commercial side so as not to reset that best price. So that is all to say, we have done assessments. We do have had some light engagement with commercial payers. We are reluctant to do anything at the outset until we get a sense for exactly what coverage rate looks like, exactly what the lay of the land is, and we'll have that access through RxConnect. And so that having been said, if you look at precedent products, a good one of which is Auvelity marketed by Axsome Therapeutics, as you know, that product enjoys 100% coverage on the government side and, last we checked, in the range of 70% coverage on the commercial side. And that's with what we perceive to be very limited direct contracting, perhaps with one PBM. And so using that as a bit of a guidepost, we will be very judicious. But we would still, out of the gate, expect enormously better coverage for EXXUA than we have for our ADHD meds and of course, just higher price points in general when you look at net pricing by virtue of the coverage on both the commercial and the government side. So hopefully, that answers your question. But we are not one to go out and announce a bunch of deals with payers that frankly may not be worth the paper they're written on. We'd rather take it one step at a time, utilize the RxConnect mechanisms to optimize reimbursement on the pharmacy front while obviously minimizing the co-pay and the hassle on the patient front. So that's how we'll approach it. Not to say we'll never contract. We'll certainly look at it, but we'll be very judicious. But I want to make sure we approach it in the right way.

Your next question for today is from Naz Rahman with Maxim Group.

Congrats on the progress. I understand you haven't initiated the full launch yet. But thus far, how much of your target prescriber market have you reached out to? And what kind of feedback have you gotten from that prescriber market thus far?

Yes. Good question. I would say probably second question first, which is nearly universally positive when you look at the doctors that are -- that we're most actively engaged with. The sweet spot for us in terms of targets is psychiatrists in our footprint that are already comfortable with our products and with RxConnect. And when you overlay sort of those 3 criteria, you get an overwhelmingly positive response. In terms of the percentage of the market that we've reached out to, still relatively small by virtue of the fact that we're trying to be hyper focused in the areas where we know we can be successful. Again, these are physician customers that are already fans of ours. They already prescribed Adzenys and Cotempla in many cases to the tunes of hundreds of prescriptions a week or -- sorry, a month or a quarter and thousands over the course of a year. And so that's really where we want to start. And we think by really kind of tripling down and not trying to spread ourselves all over and try to be all things to all people, let's be very focused and very concentrated with who we think will be the most likely to prescribe. And these are doctors, again, in our geographies, like our products, utilized our pharmacy partners. They also prescribed the newer products like Auvelity and Trintellix and Spravato. And so you put all those things together and we think that's going to lead to a relatively highly accelerated launch and then we'll expand out from there.

That was helpful. And based on the feedback you have gotten thus far from limited physicians. Have you been able to build out what a target patient profile might look like or what kind of patients that these physicians might initially treat or attempt to treat with EXXUA?

We have and this is part of our communications and part of our materials. But it's a younger patient in the prime of their life seeking to improve their life. And by virtue of that, minimize the side effects they may be experiencing on current medications. So we would rightly be targeting patients that have been on a therapy or 2 or 3 and remain dissatisfied largely due to the side effects they're experiencing with respect to sexual dysfunction and weight gain. And before they would go to another therapy that maybe has less incidence of sexual side effects, we would insert ourselves in there and say for that younger patient -- when I say younger, 18 to 50, I just turned 50, so I'd like to think of myself as still in that demographic. Those are patients ideally suited to be switched from an SSRI or an SNRI that again might be working to some degree, but it's leaving them dissatisfied from a side effect perspective. So that's the type of profile that we'll be starting with. Again, we want to be very specific. We don't want to go in and ask a physician for all of his or her patients. That's not realistic. It's not going to be really allowable by virtue of just the market dynamics and just the standardization of care given that 99 times out of 100 patients will start on SSRI or SNRI and the payers, by the way, will require that. And so we'll be looking for that switch after that. And honestly, even if we get the switch after that switch or after the switch after that, that is a huge funnel of patients to be starting with even if we're talking third, fourth, fifth, sixth or even later line. So just such a big market opportunity with 340-plus million prescriptions annually. And at the price point that we would anticipate netting. That's a huge opportunity for us even if it's used much later line.

[Operator Instructions] Your next question is from Ed Woo with Ascendant Capital.

Yes. Congratulations on all the progress. My question specifically is on your supply chain. How quickly and flexible are you to ramp up if demand is greater than you expect? And what is your leverage opportunity -- margin opportunity to get if you do get to a certain scale in terms of your margin expansion?

I'll take the first one, Ed, and hand the second one to Ryan in terms of margin expansion. I would say, generally speaking, we have flexibility. We are working through a contract manufacturer. But there is enough supply produced for, I would say, an outsized forecast even versus what we have as a base case. So we could -- we have enough produced sitting in bulk; not yet packaged, but sitting in bulk. That's multiples higher than our first 24-month forecast. And our first 24-month forecast, I wouldn't call conservative. So we have adequate supply to scale as needed. There's also API already in hand to enable us to accelerate production of sort of a second run. So plenty of product to get us started, plenty of product to ramp, again, by multiples in the event that we need to. And in terms of opportunities for margin expansion, maybe, Ryan, you can just share generally how the margin works and kind of the sales level at which we would potentially start to see a reduction in royalty.

Yes, absolutely. So as I mentioned, we have a 28% royalty. So that's not obviously related to the manufacturing of the product. But that will drop down to 24% once we hit about $1.3 billion in active sales. The actual cost of the product is only about -- we're projecting about 2% of the net revenue per product per unit. So it's pretty small to begin with. If we were to size up the batches, there's a little bit of efficiency. But it's not an expensive drug to produce in the out-front.

We have reached the end of the question-and-answer session. And I will now turn the call over to management for closing remarks.

Thanks very much, everyone, for joining us on today's call. Very excited about the progress we're making as we are on the precipice of launching EXXUA. The next time we'll talk will be in February, at which time we fully expect to be in the field, having announced our full commercial launch. So until that time, we'll be very busy getting things ready and again, continue to have a high level of excitement around this opportunity to help these many millions of patients fighting major depressive disorders. So with that, thanks again for joining. And we look forward to updating you after our second quarter wraps up on our quarterly call in February. Thanks very much and have a good evening.

This concludes today's conference. And you may disconnect your lines at this time. Thank you for your participation.