Aytu Biopharma, Inc Q1 FY2022 Earnings Call

Good afternoon and thank you for joining us for the Aytu BioPharma First Quarter Fiscal 2022 Financial Results Call. With me this afternoon, our Aytu's Chairman and Chief Executive Officer, Josh Disbrow, and Chief Financial Officer Richard Eisenstadt. Aytu BioPharma issued a press release earlier today with the details of the Company's operational and financial results for the fiscal first quarter of 2022. A copy of the press release is available on the news page of the Company's website aytubio.com. I would 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 earnings press release. In addition, a webcast will be accessible live and archived in Aytu's website within the Investors section under the Events and Presentations at aytubio.com. 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, November 15th, 2021, 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 included 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. And I'd now like to turn the call over to Aytu Chairman and CEO, Josh Disbrow.

Thanks, Matt. Good afternoon, everyone, and thanks for joining us today. Our fiscal Q1 was among our strongest quarters to date. A quarter during which we continued our post-merger integration activities, operated our newly integrated sales force, and made substantial headway advancing our pipeline programs. From a commercial perspective, I'm happy to report that we posted a very strong quarter, growing revenue 62% compared to the same period last year. These net revenues of $21.9 million represent our second highest revenue quarter in history. This growth is attributable to the realization of the newly combined product portfolio scale, following our merger with Neos, along with organic growth achieved over the same period last year across our Rx and consumer health businesses. It's important to note that our Q1 falls in July, August, and September, with a significant portion of that quarter falling in the ADHD markets during the low months of July and August. Despite just going through that low point in the year, we posted a strong revenue number and have seen solid growth during the ADHD back-to-school season. On our last call, we projected that fiscal '22 would be a year of substantial progress, and we're off to an excellent start. We successfully executed across our business and have many anticipated value-driving milestones on the horizon, all of which I look forward to discussing in more detail throughout this call. We're excited about where Aytu Biopharma stands today. As we continue to build momentum through growth in revenues from our prescription and consumer health product portfolios, maximize our newly integrated commercial infrastructure and merger synergy plan, and advance our exciting late-stage therapeutics pipeline, including rare disease asset AR101. Let me start the highlights from this quarter with a review of our commercial businesses on the Rx side, where our products compete in large therapeutic categories with approximately $24 billion in total addressable markets across five prescription therapeutic areas. We operate an efficient commercial model. Again, this quarter was the first full quarter during which we operated our fully integrated Aytu and Neos Salesforce with 50 sales specialists: 40 of which are CNS-aligned sales specialists promoting Adzenys XR-ODT, Cotempla XR-ODT, and ZolpiMist; and 10 of which are pediatric-aligned sales specialists promoting our pediatric Rx products, headlined by Poly-Vi-Flor and Tri-Vi-Flor. This recently completed sales force integration represents a significant part of the $15 million in merger synergy savings we've discussed and expect to realize as this fiscal year progresses. Our prescription brands address large and growing markets. We expect Adzenys and Cotempla to drive future growth for our CNS-focused portfolio, targeting the 70-plus million prescription ADHD market. Our prescription multivitamins Poly-Vi-Flor and Tri-Vi-Flor are expected to be the primary growth drivers for the pediatric-focused portfolio. This quarter, combined prescriptions for ADHD brands, Adzenys and Cotempla grew 12% compared to the same period last year. Adzenys prescriptions grew 15% compared to the same period last year. Importantly, since the end of the first fiscal quarter, we began capturing even more momentum. Not only did we achieve an all-time high in weekly prescriptions for Adzenys XR during the week ended October 15, but also in multiple weeks throughout October, we reached approximately 5,000 prescriptions for that brand. These numbers speak to the strong growth of the adult ADHD market, as well as the execution we're having in the field. While the pediatric ADHD market is certainly up from last year, it has not completely returned to pre-pandemic levels as the adult market has. That said, Cotempla XR prescriptions have approached all-time high levels, particularly as we hit interim report card time and the critical parent-teacher conferences for kids. Simply put, we're hitting our stride with the ADHD brands. This quarter, we also reported year-over-year revenue growth of 8% for our prescription multivitamin, reaching an all-time high in weekly prescriptions for Poly-Vi-Flor chewable tablets. That product line has also hit its stride as we continue to focus a core team of our sales specialists on growing our multivitamin franchise. To showcase our strong growth in this segment, our prescription antihistamine Karbinal ER grew 46% over the same period last year. This quarter marked the first full quarter with our newly rebranded Aytu RxConnect patient access program, which was formed from the consolidation of the Neos and Aytu patient access programs. We have added the Aytu legacy products to the Neos legacy RxConnect program to now have all core brands on this nationwide pharmacy and patient support platform. This expansion enabled substantial leverage to our program as our Rx brands are now integrated. Through innovative design and favorable economics, RxConnect enables affordable, predictable patient access. When physicians prescribe Aytu brands for any commercially-covered patients, their hassles are dramatically reduced, and patient co-pays are predictable. This program gives us a distinct market advantage, enabling us to refine our pharmacy network, bring additional assets onto the platform, and drive prescription refills at a higher rate than might ordinarily be achieved. RxConnect is quite simply a game-changer for us and an efficient way for patients and physicians to access our branded products. At a time when patient co-pays are anything but predictable, the RxConnect program truly stands out. During this quarter, we saw growth of RxConnect as a percentage of prescriptions going through our network of pharmacies and we're pleased with the quick progress we've made in integrating the full RxConnect product portfolio into the program. Going forward, we expect to see increasing revenue across our ADHD and pediatric prescription products, and expect to grow the consumer health division through organic sales growth and new product introductions. Much of that growth is anticipated to be driven by e-commerce and the expected launch of various new OTC medicines through recently signed exclusive distribution agreements with an OTC manufacturer. For our consumer health brands, we grew our revenues 3% over the same period last year to $8 million. This growth is notable as we grew year-over-year, even when last summer's e-commerce purchasing was transiently high due to the peak of the global pandemic when people were staying home and driving online shopping to levels not previously seen. Despite that large e-commerce uptick last summer, we still saw growth over that previous level this year. The growth of the e-commerce segment is important because this portion of the consumer business has lower relative consumer acquisition costs and is thus quite scalable. We believe this platform should scale to profitability as we add additional products onto it, and again, the addition of new consumer health products remains part of our growth plan along with continued organic growth moving forward. Turning now to our development pipeline. I'll start with Healight. Healight is a first-in-class ultraviolet light-based endotracheal catheter, initially targeting the treatment of severe respiratory infections in mechanically ventilated hospitalized patients. We licensed global rights to the Healight technology platform last year from Cedars-Sinai Medical Center for all respiratory applications. We announced published data from two journal publications that we believe point to the potentially groundbreaking efficacy of this anti-infective platform. These data demonstrated that UVA light reduces cellular cytokine release from human endotracheal cells infected with coronavirus and that UVA light catheter therapy is associated with a significant reduction in SARS-CoV-2 viral load, and importantly, improvement in clinical outcomes for mechanically ventilated COVID-19 patients. We remain on track to initiate a randomized sham-controlled study evaluating the safety and treatment effects of Healight in patients with SARS-CoV-2 who have been newly integrated onto mechanical ventilation. This study will be conducted at a leading academic hospital in Barcelona, Spain, and is expected to enroll 40 patients. The primary endpoint of this study is the change in viral load in endotracheal tube aspirates between days 0 and the last day of treatment between treated and untreated patients. Following the completion of enrollment, we expect to report top-line data in the first half of calendar year 2022. The data we've reported continue to demonstrate the profound commercial opportunity for Healight with potential applications to diseases outside of COVID, such as ventilator-associated pneumonia, severe influenza, and other difficult-to-treat infections. We are excited to explore the depth of Healight's potential and are already planning our first study outside of COVID-19, focusing on ventilator-associated pneumonia. We expect that proof-of-concept study to also commence this quarter. Our pipeline is highlighted by AR101, a pivotal study-ready new chemical entity that targets the treatment of the pediatric-onset rare disease, Vascular Ehlers-Danlos Syndrome (VEDS). VEDS is a rare genetic disorder typically diagnosed in childhood and characterized by arterial aneurysm, dissection, and rupture. There are currently no FDA-approved treatments for VEDS. VEDS is easily diagnosed with a genetic test confirming the COL3A1 mutation, and approximately 6,000 patients in the U.S. have VEDS, making the targeting of these patients straightforward in terms of clinical trial enrollment and, if approved, ultimately locating and treating those patients. In September, we announced the formation of a scientific advisory board consisting of leading experts in rare genetic pediatric disease, chaired by Dr. Hal Dietz of Johns Hopkins, who has conducted groundbreaking research to date supporting AR101 in VEDS. With the formation of and frequent interaction with this advisory board, the Company is well positioned to execute on the development of AR101 for the patients who desperately need this treatment. We've held numerous advisory board meetings as we continue to evolve the protocol and study plans, as well as identify prospective study sites. We are currently pursuing orphan drug designation from both the FDA and EMEA with the goal of receiving this status in the first half of calendar year 2022. We plan to launch a pivotal study, referred to as the PREVENT trial of AR101 in patients with VEDS, with an enrollment of approximately 260 COL3A1 positive patients, who will be randomized one-to-one. The primary endpoint of this study is the reduction of fatal or non-fatal arterial events, such as ruptures, dissections, and pseudoaneurysms. We expect to study patients taking standard background medications like beta blockers and ARBs with and without enzymes, imaging those patients every six months over a 30-month treatment period. We're planning on an interim analysis and will also capture secondary endpoints, including safety measures. We expect to initiate the study in the first half of 2022 and fully enroll the study in Q1 of 2023. We've also held numerous patient advocacy group events around VEDS in support of Ehlers-Danlos, specifically including the Ehlers-Danlos Society, the VEDS Movement, Fight VEDS, and Annabelle's Challenge. All these organizations are highly engaged with us and have been instrumental in assisting with patient site identification and providing support for VEDS patients and the overall VEDS community. With that, I will now turn the call over to Rich for some additional financial highlights.

Thank you, Josh, and thank you everyone for joining us this afternoon. As of September 30th, 2021, we had $40.6 million in cash equivalents and restricted cash. Our borrowing on the revolver at the end of September was only $4.5 million versus $7.9 million at June 30th, 2021. Revenue for the fiscal quarter ended September 30th, 2021, was $21.9 million, compared to $13.5 million in the same quarter in 2020, a year-over-year increase of 62%. Net revenue from the consumer health division for the three months ended September 30th, 2021, was $8 million compared to $7.8 million in the same quarter last year, representing over 3% year-over-year growth. The third calendar quarter is historically a low quarter for the consumer health business, and as Josh mentioned, we're pleased to continue growing this business over the transient spike we experienced last year during the pandemic. Net revenue for the prescription division for the three months ended September 30th, 2021, was $13.9 million, up from $5.8 million in the same quarter last year. This concludes our second full quarter of ADHD revenue. As Josh mentioned, July is historically the slowest month of the year for ADHD prescriptions before rebounding in August and particularly September with the start of the back-to-school season. The market did see a slightly slower return to the back-to-school prescriptions compared to prior years, particularly in the methylphenidate market, as several schools had delayed reopenings and continued remote learning. Gross profit for the three months ended September 30th, 2021, was $12.5 million versus $9.5 million for the same months in 2020. This was the highest quarterly gross profit posted in the history of the Company. Gross margin rebounded to 57%, as previously projected, following the full expensing last quarter of the ADHD-written-up inventory costs following the Neos acquisition. For the first fiscal quarter of 2022, the net loss was $27.9 million, or $1.9 per share, compared to $4.3 million, or $0.35 per share for the same period last year. The net loss reflects an impairment charge of $19.5 million, resulting from an assessment of the carrying value of the Company's assets in light of the recent decline in stock price. Adjusting for the impairment charge and the related tax effect, the net loss for the quarter would otherwise have been approximately $8.5 million or $0.33 per share. I will now turn the call back over to Josh for some additional commentary.

Thank you, Rich. As you can see, we've made significant headway toward value creation as a leading specialty pharmaceutical company with a growing developing pipeline. Going forward, we are committed to focusing on growing revenues from our core Rx business, supported by revenues from our consumer health business and building our pipeline led by AR101 and Healight. As we continue our trajectory, we expect to identify and potentially bring in accretive complementary products in late-stage pipeline opportunities to further expand our business. For Healight, we remain on track to initiate our study in Spain shortly with top-line data expected in the first half of 2022, and we're initiating a proof-of-concept study in ventilator-associated pneumonia. For AR101, IND submission preparations and study site identification and qualification are underway for the planned pivotal clinical trial, which we expect to start in 2022. As I previously stated, we believe we have the right products to drive our growth. We have a driven team and a highly focused sales force, and we have a therapeutic pipeline with real potential. We have strong momentum at the moment. We're really proud of where we stand today and look forward to updating you on our progress. I'll now turn the call back over to the Operator for Q&A.

Certainly, your first question is coming from Jennifer Kim from Cantor Fitzgerald. Your line is live.

Hey everyone, thanks for taking my questions. I have a couple here. First, just on R&D. I think you mentioned for Healight you're also exploring a study outside of COVID. Can you just clarify if there will be two studies this year, and how we should think about the costs of that going into our R&D modeling? And then my second question is for the quarter, how much of the revenue came from the ADHD products?

Thank you, Jennifer. I'll take the first one, and thanks for your questions. With respect to R&D and Healight, we are anticipating starting a study in ventilator-associated pneumonia, Jennifer, which will be a pre-clinical animal study based in the same hospital that we'll be conducting the COVID study. We expect to kick that off shortly. That's relatively nominal in terms of the overall costs, and that will simply establish proof-of-concept concerning UVA light catheters' ability to eradicate the pathogens that are most typically associated with ventilator-associated pneumonia. That's a straightforward study, low cost, and will primarily be exploratory. In terms of a timeline, we expect to kick that off this quarter, and results from that study will likely be available in the first half of calendar 2022.

Jennifer, the ADHD portfolio generated approximately $9.7 million in the quarter.

Great, thanks. And historically, since this is a little secret for ADHD, what does the quarter-over-quarter growth look like as you get into that back-to-school season historically?

Yeah, so normally the two lowest quarters of the year are June and September. The June quarter was $10.6 million and the September quarter was $9.6 million. Historically, we see significant growth in the fourth fiscal quarter due to the back-to-school effects. We typically see a 30%-35% what I call peak-to-trough reduction in revenue between May and July.

That's helpful. Thanks, guys.

Thank you.

Thank you. There are no further questions in the queue. I will now hand the conference back to Josh Disbrow for closing remarks. Please go ahead.

Thank you, Matt, and thanks everyone for joining us today on the call. We're really pleased with the progress we've made to date, and we look forward to updating you on our progress in our next call. Until then, have a good evening. Thanks again.