Josh Disbrow
Analyst · Maxim Group. Your line is live
Thank you, Robert and welcome everyone. I'm pleased to be speaking with you again this quarter. During the second fiscal quarter, we successfully returned both our ADHD and pediatric portfolios to positive sequential prescription growth. The first such occurrence in which both portfolios exhibited sequential growth since late 2022. Our commercial team has done a great job navigating the various dynamics of the macro landscape for our addressable markets with our sales team increasing physician demand as we also drive improvement in payer coverage and broadened distribution and dispensing. And we're doing this while continuing to leverage the benefits of our first-in-class Aytu RxConnect platform. I'll touch more on both our ADHD and Pediatric market trends in a moment. This positive commercial momentum runs parallel to our corporate optimization initiatives, driving efficiencies within our operating structure with at least $2 million in future cost savings expected annually. This cost savings we recently announced is in addition to the significant OpEx reductions we're already realizing as a result of the transformation we have undergone in the last two years, inclusive of pausing pipeline spending, discontinuing our consumer health operations and exiting our manufacturing operations. Our focus going forward is on our profitable prescription business and leveraging the unique capabilities of our commercial infrastructure in the Aytu RxConnect platform, while also pursuing additional in-licensed or acquired products, I'll touch more on that as well momentarily. Even before the full realization of our optimization savings takes hold, we reported our seventh consecutive quarter of positive adjusted EBITDA and second consecutive quarter of net income. And we remain on track to drive the business to positive cash flows. In fact, our cash balance at the end of December was $20.4 million, which was up slightly from $20.1 million at the end of September. All told, I'm very pleased with the continued progress made during the second quarter and the outlook for the rest of the fiscal year. Let's jump into the script numbers, trends and outlook for each of our portfolio areas, starting with ADHD. For the quarter, scripts for the ADHD portfolio were slightly over 99,000, which compares to just under 99,000 in the first quarter and compared to 111,000 in Q2 of last year. From a top line perspective, ADHD net revenue was $13.8 million in Q2 compared to $15.3 million in Q1 fiscal 2025 and compared to $16.6 in Q2 of last year. We went into great detail last quarter discussing the commercial re-pickup we had that boosted ADHD net revenue. But I want to once again call this out as it highlights the improvement we saw during this quarter on an apples-to-apples net revenue basis. As you'll likely recall, last quarter, we resolved a multiyear rebate dispute with a payer over unauthorized commercial rebates on our ADHD products, which had previously reduced our net revenue in prior periods, and for which we have been carrying a gross to net accrual. We resolved that last quarter and the resolution resulted in a onetime increase in net revenue of $3.3 million during the first quarter and a reduction of that liability we've been carrying on our balance sheet for the past few years. If you back out the $3.3 million from Q1's net revenue, ADHD net revenue would have been $11.9 million. So, the $13.8 million we just reported in Q2 on approximately 99,000 scripts compares very favorably with $11.9 million in net revenue on also about 99,000 scripts in Q1. So our per script net price actually increased sequentially. ADHD net revenue was up 16% sequentially on an apples-to-apples basis, excluding a one-time item. This highlights an improvement in our gross to net, which given our business model is somewhat to be expected heading into the final quarter of the calendar year. Looking more broadly at the ADHD stimulant market, we continue to see conditions returning to a more normalized state following the series of significant market-wide stimulant shortages commencing in early 2023 and that impacted the supply of products like Adzenys XR and other ADHD stimulant meds. As I've discussed, fortunately, Aytu supply was never impacted and we, therefore, realize some short-term and long-term benefits from the shortages others were facing. With the market more normalized, the short-term benefit we had has made the comps a bit difficult on a year-over-year basis. But as I mentioned a moment ago, the sequential trends are once again quite positive and we are above the base levels from just a few years ago as many patients that were moved over to Adzenys or Cotempla have stayed on longer term. I'll transition now over to the Pediatric Portfolio. As we've communicated for the last few quarters, within Pediatrics, we were impacted by a variety of payer changes. Initially, we saw the impact when a large payer stop covering a big portion of Pediatric multivitamins affecting the entire multivitamin class. This was exacerbated further as we had some fairly concentrated dispensing areas where this payer has a large market share. Our antihistamine was affected similarly by a payer change in an area where we had a pretty significant concentration of prescribers with that product largely covered by Medicaid. Fast forward, we've been focused on diversifying the prescriber base and improving payer coverage for both franchises, multivitamins, as well as with our antihistamine franchise. In particular, we've focused on expanding areas of promotion, diversifying our base of dispensing pharmacies and bringing on several state Medicaid plans that we hadn’t had covering our products before. So as opposed to having all of our eggs in the proverbial one or two baskets, we are in many more states today that are covering our products, and this improvement has largely occurred over just the last six or so months. With that, Q2, is really the first quarter that we started to realize the benefits of this improved coverage and access with materially better public and commercial coverage for our Pediatric brands. We've also deployed sales representatives and shifted resources to our Pediatric products. Previously, Pediatric sales were conducted with a much smaller group of sales specialists that focused on promoting these products. We've now shifted our sales force's product mix, providing for better balance and more impactful product penetration and specifically with increased emphasis on the Pediatric products across much of the sales force. As you saw in the press release, we're seeing dividends already and are very encouraged by our latest Rx and net revenue trends. During Q2, Pediatric portfolio net revenue was up 86% sequentially as scripts increased materially. We're not yet back to where we were a few years ago, but I'm pleased with the positive trends over the last two quarters and a $10 million annualized run rate for these products when you look at this current quarter. We're continuing to see good momentum as we again implement on our three key strategies: improve coverage, diversify the base of fee prescribers and diversify and increase the promotional footprint with the sales force. More broadly, we remain focused on continuing to leverage our flagship best-in-class patient access platform, Aytu RxConnect, which we believe is a significant differentiator for the company and one that enables us to stand apart from the competition and truly benefit patients. Indulge me for just a moment to hop on my Healthcare ecosystem, soapbox here. In today's healthcare environment, it's simply not enough as a pharmaceutical company to go to a prescriber and offer better clinical solution. You've got to solve the entire problem for the patient, which of course, includes the clinical benefits, but you absolutely have to solve for the pervasive payer access challenges, that impact patients, pharmacies and physicians alike. Patients today can walk into a neighborhood, Walgreens, CVS or Walmart and frankly, have no idea whether they're going to get the product that they were prescribed, if it is going to be received in a timely manner and if and when they can get it, what price they're going to pay when it comes to an out-the-door all-in cash pay, whether that's in the form of a co-pay, whether they're paying cash or whatever the case might be. The US Pharmaceutical Distribution and Payment System is very opaque. The market lacks transparency and consistency, and that's where Aytu RxConnect comes in. This is a proprietary soup to nuts, so to speak, top-to-bottom program that we've developed in-house here at Aytu. Its value-add, protects the dispensing pharmacy, provides confidence to the prescriber, caps patient cash outlays and reduces their hassles and ultimately allows patients to get that branded prescription at an affordable, predictable price. RxConnect involves, among other things, a network of about 1,000 pharmacies with whom we work around the country. Most of these are independent pharmacies in local geographies that do an excellent job for patients and prescribers and are often well established and well recognized in the respective communities. They're small businesses that work very hard to serve patients well and go above and beyond and deliver high levels of service for patients. The other part of our network is two regional grocery chains that are very customer-centric, provide excellent service and work directly with us to adequate stocking of our products and to make them more available. So as mentioned, when we sell our products, we obviously sell physicians on the benefits they offer their patients from a clinical standpoint, and then equal parts tell them that if they will send these prescriptions to one of these partner pharmacies, they will get the full benefits of RxConnect, which include everything up to, including a co-pay, not to exceed $50 for patients that are commercially insured and when covered, the co-pay, by the way, is often $0. We essentially underwrite the prescription in cases where it's not covered or there's a step edit or a prior authorization that may prevent access. And even in cases where there is a prior authorization, our partners can help obtain that okay, thus taking much of that burden off the physician’s office. This helps the patient first and foremost, get the product they were prescribed at a price that's predictable affordable. It also helps physicians know that their patient is getting the prescription as prescribed and on time. As a reminder, these are products that you're going to take routinely, month after month for many, many years, potentially for the rest of your life. o it solves this significant issue today where you can walk into your chain pharmacy. And next month, you may pay a different price than you paid this month, and that's the way CBMs have designed it to be opaque and to make it very challenging for patients. And so with RxConnect, we have freed up physicians to prescribe our brands without fear of the dreaded callback from a pharmacy saying either we don't have it, we can't get it or even worse, the parent of a patient calling back saying that was ridiculous, crazy high co-pay that was way beyond what I expected or my means. We cut through all of that. For the first time with RXConnect, we have put the prescribing power back into the hands of the physicians and the patients. And that's why with RXConnect, we believe at Aytu, we can succeed. And for us, success is winning for prescribers, for patients and for pharmacies alike. And that's what we're working to achieve for these stakeholders every single day. The Aytu RXConnect program develops our products really is the game changer that enables these products to stay in the part. And we think this will be a key differentiator as we look to the future of our ADHD franchise, our Pediatric franchise and dovetails into what the future of Aytu has the ability to look like. On that note, as we look at the mid and long term, we first and foremost need to focus on the continued organic growth of our ADHD and Pediatric portfolios, and cost containment initiatives with the goal of driving towards our goal of positive cash flows. Beyond that, we also expect inorganic growth, understanding that Aytu has been built through a series of strategic transactions. Throughout our history, we have shown that we are adept at identifying smallest yet valuable assets that maybe don't fit at a particular organization and have become non-strategic. So we see tremendous opportunity to leverage our infrastructure capabilities and expertise and to diversify our portfolio by in-licensing or acquiring assets like these. Of course, we'll be smart about it and look to pick these assets up as attractively as possible. For now, the appetite is for smallish tuck-in assets that we that we can bolt on and fit within our commercial footprint in our low cost. And then hopefully, as generate free cash flows, we can also start to look at incrementally larger opportunities in the not-too-distant future as well. Ultimately, our goal in this area is to continue to bolster the portfolio, diversify the revenue base further and allow us to continue to leverage our high-performing commercial infrastructure. Let me now turn the call over to Ryan to review the financials in more details, after which I'll provide a few closing comments, and we can take your questions. Ryan?