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Aytu BioPharma, Inc. (AYTU)

Q1 2022 Earnings Call· Mon, Nov 15, 2021

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Transcript

Operator

Operator

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 that 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.

Josh Disbrow

Management

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% of 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 big chunk of that quarter falling in the ADHD markets, low months of July and August. And despite having just gone through that low point in the year, we posted a strong revenue number and have been -- have seen solid growth during the ADHD back-to-school season. On our last call, we projected that fit -- fiscal '22 will 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 what Aytu pharma -- 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 yield like and rare disease asset AR101. Let me start the highlights from this quarter with a review…

Richard Eisenstadt

Management

Thank you, Josh. And thank you everyone for joining us this afternoon. At 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 core $4.5 million versus $7.9 million at June 30th, 2021.That 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 3 months ended September 30th, 2021 was $8 million compared to $7.8 million in the same quarter last year. A growth of over 3% year-over-year. Third calendar quarter is historically low quarter for the consumer health business, and as Josh has mentioned, we're pleased to continue growing this business over a transient spike last year into the pandemic. Net revenue for the prescription division for the 3 months ended September 30, 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 as compared to prior years, particularly in the methylphenidate market as a number of schools had delayed reopenings and continued remote learning. Gross profit for the 3 months ended September 30th, 2021 was $12.5 million versus $9.5 million for the 3 months ended September 30th, 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, Net loss was $27.9 million or a $1.9 per share as compared to $4.3 million for $0.35 per share, for the same period last year. Net loss reflects an impairment charge of $19.5 million, resulting from an assessment the carrying value of the Company's assets in light of the recent decline in stock price. Adjusting out 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. Josh.

Josh Disbrow

Management

Thank you, Rich. So as you can see, we've made significant headwind 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 consumers health business and building our pipeline, led by AR101 and Healight As we carry on with our trajectory, we expect to continue to identify and potentially bring in accretive complementary products in late-stage pipeline opportunities into 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 and we expect to start that trial 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 Salesforce, 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. Matt.

Operator

Operator

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

Jennifer Kim

Analyst

Hey everyone, thanks for taking my questions. I have a couple of 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 such a case that there will be 2 studies this year, and then how we should think about the costs of that going into our R&D modeling. And then my second question is for the quarter, the ADHD products, how much of the revenue came from those products?

Josh Disbrow

Management

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 ammonia, Jennifer, to pre -clinical animal study, based in the same hospital that we'll be conducting, expected kick that off shortly. That's relatively nominal, in terms of the overall costs, and that will truly just establish proof-of-concept in terms of UVA light catheters ability to eradicate the pathogens that are most typically associated with ventilator associated ammonia. That's a relatively low cost, relatively straightforward study to get done, so it'll really be exploratory. It does, in -- from a timeline perspective, again, expect to kick that off here, this quarter. Until we get it underway and understand the relative ease with which we can get the animals dose, so to speak, we won't necessarily report out exactly when, but I would expect it's a study that will take us less than 5 to 6 months. Realistically, first half of calendar 22, we would expect to see results from that.

Richard Eisenstadt

Management

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

Jennifer Kim

Analyst

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?

Richard Eisenstadt

Management

Yeah. So normally the 2 lowest quarters of the year or the mar -- June quarter and September quarter. So the June quarter was 10.6 and the -- like I just mentioned the September quarter 9.6 is normally -- fairly significant growth in the fourth fiscal quarter because, we've had the back-to-school October is usually a big -- as Josh had mentioned, report cards, first parent teacher conference. It's usually a second spike for ADHD. It's usually tremendous growth. I don't have the exact percentage. There's usually a 30%-35%, what I call peak to trough. So between May and July, a reduction in revenue, about 35%

Jennifer Kim

Analyst

That's helpful. Thanks, guys.

Josh Disbrow

Management

Thank you.

Operator

Operator

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.

Josh Disbrow

Management

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