Joshua Disbrow
Analyst · Lake Street
Thanks, Robert, and welcome, everyone. I'm very pleased to be speaking with you today following what has been an exciting first partial quarter of commercial launch activity for EXXUA. As we've discussed, EXXUA represents a significant new opportunity for Aytu. It's the first and only selective serotonin 5-HT1A receptor agonist ever approved by the FDA for the treatment of major depressive disorder in adults. And EXXUA is already demonstrating very solid growth trajectory within the MDD category. During our last call and during our Investor Day back in January, we spent meaningful time on the market opportunity, the clinical rationale, the unmet need in MDD and the strategy behind our commercial launch. Today, I want to focus more directly on execution and some of the things we're seeing with respect to early adoption. Simply said, while we are still very early in the launch, the fundamentals we are seeing are highly encouraging, and the launch is progressing very well. So let's dive in. As most of you are aware, we moved from initial commercial availability in our second fiscal quarter in December into a more formalized launch phase during our third fiscal quarter. EXXUA was made commercially available back in mid-December. The initial tranche of the sales organization completed training in January, while broader field deployment of the full 40-plus sales representatives didn't actually begin until late February, early March. That timing is important. While Q3 was our first meaningful commercial quarter, it was still only a partial quarter of full sales support and commercial deployment, with roughly 1/3 of the sales force only getting into the field in March. So we're just getting started. The most important point here, though, is that physicians are already writing EXXUA. Patients are beginning therapy and very early refill activity is already becoming evident. In Q3, more than 1,300 prescriptions were written for EXXUA. The monthly progression is particularly encouraging with prescriptions increasing from about 200 in January to about 400 in February to over 700 in March. That type of sequential growth is exactly what we hope we would see in the early stage of a launch as awareness builds, our representatives increase their reach and frequency and as physicians begin to identify patients who may be appropriate for EXXUA. Importantly, that momentum has continued. In April, we saw over 920 prescriptions written, up from the 700 in March. That's a 26% month-over-month sequential growth rate. Further, we shipped over 1,300 units shipped in April, which is 51% sequential growth, and that's more than the prescriptions generated in the entire first quarter. While it's early, and we will avoid over extrapolating from any short period term of data that continued month-over-month acceleration clearly demonstrates that physician interest is building and that the launch is getting traction. We're also encouraged by the breadth of early prescriber adoption. During the quarter, more than 450 unique prescribers wrote EXXUA prescriptions. That is meaningful because our initial focus call universe is approximately 3,500 to 4,000 highly targeted prescribers. So at this very early stage, already 10% to 13% of our target universe has written EXXUA. And yet again, we're just getting started in building a solid base of physician adoption. We believe this points to a substantial opportunity ahead as the sales force actively increases as our access initiatives mature and as peer-to-peer in rep-based education expands. As most of you know, unit sales and prescription counts are not the same measure. Units reflect product moving through the channel and into distribution networks and ultimately into pharmacies, while prescriptions reflect what physicians rather are writing for patients. In a launch, those numbers can move at different rates because of channel stocking, titration pack and full prescription ordering, refill timing, et cetera. With that said, during Q3, gross unit sales were 3,335 units, consisting of 1,807 30-count units or full 30-day prescriptions and 1,500 titration units. Since launch, total gross unit sales are 3,881 units, consisting of just under 2,030 count bottles at 1,991 and 1,890 titration units. So again, highly encouraging numbers at this very early stage. When we look at the combined picture, we see a launch that is doing what we expected it to do. Physicians are beginning to prescribe, patients are starting and staying on therapy, titration packs are being utilized, channel partners are ordering and they're already reordering product. Very importantly, refills are beginning to come through, and we're seeing momentum build month over month over month. Taking a step back, a key reason we're encouraged by the launch is that the elements of our launch plan are now moving into the market and functioning as they had been designed. We built this launch to be disciplined, efficient and scalable. Initially, we are not trying to outspend larger competitors. Instead, we're being very disciplined by focusing on the prescribers most likely to understand the unmet need, evaluate EXXUA's differentiated profile, value our access programs and become early adopters. Our sales organization is specifically prioritizing high-value, high-prescribing psychiatry practices. Our customer targeting has been informed by market data, branded therapy adoption behavior, existing Aytu relationships and insights gained from our RxConnect platform. We believe that this is the right approach for EXXUA at this stage. The product will not benefit from broad, unfocused promotion at this important time. Right now, it needs focused engagement with clinicians who treat high numbers of MDD patients every day and who understand the limitations of existing therapies and are looking for new treatment options. The phased deployment of the sales team has also been intentional. With only a partial quarter of full sales force support, the early prescription and prescriber numbers are even more encouraging. We believe there remains meaningful room for growth through increased reach and frequency and, of course, execution against the target universe that's already been identified. Again, this is just the beginning without a full quarter of promotion even in the books yet. Aytu RxConnect has been and will continue to be a core pillar of the EXXUA launch. Our objective is to remove friction for both prescribers and patients, particularly in the early months when coverage policies and payer processes are still developing. Through RxConnect, commercially insured patients have a predictable and supported pathway to access EXXUA, including a no-cost, 14-day titration pack and guaranteed access through the early treatment period for commercially insured patients specifically. That allows clinicians and patients to evaluate the medicine based on clinical response rather than on early administrative or payer-driven barriers. This is particularly important in major depressive disorder, where patients and physicians need confidence that therapy can be initiated and continued long enough to assess response and tolerability. By reducing uncertainty at the point of prescribing, RxConnect helps align our commercial model with real-world clinical needs. We're also seeing our channel partners execute well. The more than 3,300 units sold during the quarter demonstrates preparedness across the distribution network to support the current prescription demand along with the growth we're seeing. The early launch period is not only about demand generation, it is also about making sure that when a physician prescribes EXXUA and a patient is ready to begin therapy, that product is available and the process is smooth. The qualitative feedback from the field remains consistent with the launch thesis we had laid out previously. Physicians understand that many patients with MDD do not achieve adequate outcomes with existing therapies or struggle with tolerability issues that can affect adherence. EXXUA gives these patients and these clinicians a differentiated option with a novel mechanism of action, and that message is clearly resonating. As it relates to physician adoption, that will build methodically as it always does. Physicians often start by identifying specific patient types where they believe EXXUA may be especially relevant or in some cases, patients who have been through a long list of antidepressants already and they're simply searching for something new. Our job is to continue educating, supporting access and building confidence through clinical experience. The fact that hundreds of prescribers have already written EXXUA gives us confidence that this process is working well and that even very challenging patients, in fact, are reporting positive results. We're also highly encouraged by the early refill activity. Refills are an important proof point because they demonstrate that initial prescriptions are progressing into continued therapy. The base of patients is still relatively small, but the presence of refill activity, together with growth in titration utilization and sequential prescription increases clearly demonstrates that prescribing is picking up and that EXXUA is beginning to establish a role in the treatment of MDD. Most importantly, the patient feedback we're hearing from our prescribers is nothing short of outstanding. Phrases from even difficult patients like "lifechanging" and a specific patient saying, "He has never felt this good in his entire life." are coming through at this point almost daily. Yet again, we're just getting started. We're highly confident we'll continue to hear more and more of these patient success stories. As we move ahead, our priorities are clear. First, we will continue increasing prescriber calls within the initial target prescriber universe. We are only again at the beginning of that process. And our current prescriber base represents a small, a tiny fraction of the opportunity we have identified and an even smaller fraction of who will ultimately be prescribing EXXUA. Second, we will continue leveraging RxConnect to support access and reduce friction. We expect access, reimbursement, gross-to-net and refill dynamics to all become clearer as the launch matures, and we'll remain disciplined in adapting our approach based on the data. By the way, the early signs on both coverage and reimbursement rates are extremely positive across both commercial and government payer channels, we're seeing solid and increasingly good coverage of EXXUA among commercial plans and Medicaid and Medicare scripts are making up an increasing portion of the overall script load. It remains early, but many of the positive payer dynamics we've spoken about prelaunch are, in fact, bearing out. Third, we will continue investing in scientific engagement, KOL development, peer-to-peer programs and publication and medical congress activity. We believe EXXUA has a differentiated profile and the more physicians understand where EXXUA fits into their prescribing, the more opportunity we have to grow. We had a significant presence at a major psychiatric conference last weekend, the Neuroscience Education Institute Spring Congress. And as expected, interest and feedback and follow-up from the conference attendees was excellent. Finally, we will maintain commercial discipline by aligning investment with performance and using cash flows from the legacy business to support the highest growth opportunity in the company, and that is clearly EXXUA. Turning now briefly to our legacy portfolios. ADHD net revenue was $9.1 million in the quarter compared to $15.4 million in the prior year period. As expected, the decrease was primarily driven by a strategic shift in sales force focus late last summer towards EXXUA and some impact from the introduction of generic competition for Adzenys as well. Despite the overall shift in promotional priorities, the ADHD portfolio remains a very important contributor to Aytu and given the lack of commercial support currently behind the brands, we continue to view the portfolio as profitable and durable on a stand-alone basis. The uptake of the third-party generic against Adzenys has been quite low, which has been encouraging with only achieving about 14% market share through 4-plus months of market availability. This tells us that the protective characteristics of the RxConnect program are proving protective given relatively little erosion as a percentage of the overall scripts written within the RxConnect ecosystem. The vast majority of decline due to the generic is coming from outside the RxConnect ecosystem. So things are working as we had expected and as we had designed. Our Pediatric Portfolio generated just under $1 million of net revenue in the quarter compared to $3.1 million in the prior year period. We continue to efficiently service our pediatric products and believe that while small, these mature products will continue to be durable sources of profitable revenue. Overall, the legacy business continues to provide an important foundation as we transition the company towards the larger CNS opportunity, clearly represented by EXXUA. Our goal is to balance disciplined investment in EXXUA with continued cash generation from the existing business and the existing base business does generate cash even at these levels and even at lower levels. In summary, we're very pleased with the first meaningful quarter of EXXUA launch activity. We generated $2.4 million of revenue specifically for EXXUA, saw more than 1,300 prescriptions written in the quarter, had more than 450 unique prescribers write the product, sold more than 3,300 units into the channel during the quarter and saw great momentum and continued growth into April with almost 1,000 prescriptions generated. Importantly, this was achieved with only a partial quarter of full sales force support and with only a small percentage of our initial target universe writing prescriptions. We're still very early. I can't emphasize that enough. There will be normal launch variability as market, payer access, prescribing and refill dynamics all settle out, but the proof points we have in hand are encouraging, and they reinforce our conviction that EXXUA can become a significant treatment option for patients living with major depressive disorder and a very meaningful growth driver for Aytu. With that, let me turn the call over to Ryan to review the financials in more detail. Ryan?