Aytu BioPharma, Inc.

Greetings. Welcome to the A2 Biopharma Fiscal 2026 Q1 Earnings Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press Store 0 on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to your host, Robert Bloom, 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 A2 Biopharma's fiscal 2026 first quarter operational and financial results for the period ended September 30, 2025. Joining us on today's call is A2's Chief Executive Officer, Josh Disbrow. and Ryan Sohorn, 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 your attention to 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 A2 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. Action 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. A2 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 A2 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 one-time 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 actual launch preparations, we were 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 A2RS Connect 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 Exua launch remains on track to occur by the end of calendar 25, with significant advancements being made to ensure success, including KOL engagement, Salesforce training, product positioning, messaging, campaign development, and pricing, payer assessments, and integration within RxConnect. We continue to believe Exua is a game-changing opportunity for A2, and the past few months have really reinforced that belief. Let's dive into our actual 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 Salesforce 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 Salesforce launching product 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 Exua 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 Exua into our A2 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 Exua as it relates to coverage and the typical barriers they face when prescribing new brands. And the final key launch activity has been to ramp up in our key opinion leader engagement. Exua has a long history of peer-reviewed publications, and that was added to recently by yet another peer-reviewed article discussing Jepperon and the class of 5HD1 agonists. Further, we recently attended our first medical conference. the Neuroscience Education Institute Fall Conference in Colorado Springs. The response to Exua 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 Exua to the medical community and engagement with the scientific community. Finally, as most of you likely saw, we were successful in getting the Exua method of use patent for Exuas 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 lifecycle management approaches, which might extend exclusivity beyond 2030. This is all to say we are laser-focused on the successful commercial launch of Exua 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 Exua is quite simply transformational for A2. Turning back quickly to the ADHD portfolio. As most of you know, there has been a long since negotiated paragraph four settlement agreement with Teva, whereby they were allowed to enter the market with a generic to Adzenis back on September the 1st. As we sit here today on November 13th, more than two 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 longstanding 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 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 Adzenis on September the 2nd. This AG will serve as an important offensive tool in what we believe will help us maintain a material share of the Adzenis market irrespective of a potential generic entry by having a truly equivalent version of the 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 two 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 broader impact or 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 31st, 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 A2 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 30th. 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 31st communications on fluoride supplementation, the American Dental Association issued yet another press release that clearly supports supplementation, and the association doubled down and continued with their recommendation to continue with fluoride supplementation in areas where fluoridated 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.