Aytu BioPharma, Inc. (NASDAQ:AYTU) Q1 2024 Earnings Call Transcript

Aytu BioPharma, Inc. (NASDAQ:AYTU) Q1 2024 Earnings Call Transcript November 14, 2023

Aytu BioPharma, Inc. beats earnings expectations. Reported EPS is $-0.00148, expectations were $-0.04.

Robert Blum: Good afternoon, everyone, and thank you for joining us for Aytu BioPharma’s Fiscal 2024 First Quarter Financial Results Conference Call for the period ended September 30, 2023. Joining us on today’s call is Aytu’s CEO, Josh Disbrow, and the company’s Chief Financial Officer, Mark Oki. At the conclusion of today’s prepared remarks, we’ll open the call for 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 earnings press release issued earlier today. Finally, I’d also like to call your attention to the customary safe Harvard 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, 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 including 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.

With that said, I’d like to turn the event over to Josh Disbrow, Chief Executive Officer of Aytu BioPharma. Josh, please proceed.

Josh Disbrow: Thank you, Roger, and thanks, everyone for joining us. I’m once again excited to be speaking with you today following yet another quarter that showed positive results from the initiatives we’ve undertaken in position Aytu. It’s a specialty pharmaceutical company focused on commercializing novel therapeutics, and it’s continuing proof that we’re clearly executing on our plan. I’m thrilled with the team’s progress across the board, and I believe we’ve put ourselves in the best position we’ve ever been in as a company. I’m happy to share that this was our second consecutive quarter of company-wide positive adjusted EBITDA, and the fifth out of the last six quarters of positive adjusted EBITDA for our Rx segment, which is where our focus is now and going forward.

The deliberate strategic plan we undertook to place the company on a financial pathway to sustainability started initially about a year ago when we indefinitely suspended our clinical programs to minimize R&D expenses until such time that we can fund those efforts either with internally generated cash flow or through a strategic partnership. It then continued in June of this year when we announced that we would focus our commercial efforts exclusively on our growing and positive adjusted EBITDA Rx segment. We did this while de-emphasizing our consumer health segment and winding down those unprofitable operations and potentially monetizing it. As we progress along this path, our Rx segment composed of our ADHD and pediatric products becomes the go-forward business.

We are laser-focused on growing prescriptions, increasing Rx revenue and driving EBITDA and cashflow. Positive EBITDA is our calling card, and we’re executing on that front. Further, we’re growing prescriptions while also reducing OpEx, which we’ve done. This is all part of our measured plan, and I’m proud of our results. During the first quarter, our ADHD brands’ prescriptions grew an impressive 28% over the first quarter of last year, which is a testament to the commercial team’s strong execution and our ability to effectively leverage our innovative Aytu RxConnect patient access platform. From a revenue standpoint, ADHD net revenue aligned closely with script growth, increasing 31% to $15.1 million compared to $11.6 million in the year ago quarter.

We’re also focusing on driving manufacturing efficiencies and improving OpEx and margin improvement. Overall, margins during the first quarter improved to 67% compared to 65% in the year ago first quarter. And as Mark will share shortly, our operating expenses are down materially. In the coming quarters, our ADHD products will benefit from the recent FDA approvals of the Cotempla XR-ODT and Adzenys XR-ODT manufacturing site transfer prior approval supplements or PAS. These two PAS approvals allow us now to ramp up manufacturing and our contract manufacturer for ADHD brands and will be a key driver of further gross margin improvement as we get at Adzenys and Cotempla fully transitioned. As I touched on the past few quarters, the trends we talked about within the ADHD category continue to persist, including the supply disruptions for generic Adderall XR and various methylphenidate products and several stimulant products have been discontinued altogether as of late.

At least three generic manufacturers have discontinued their Adderall XR generics in the past few months and another large generic manufacturer is no longer marketing its extended release methylphenidate, so the problem continues. Just last month, I read a TIME Magazine article titled, One year later, where’s all the Adderall? In the article, it highlights that October 12 marked one year since the FDA’s formal announcement that pharmaceutical manufacturers weren’t able to produce enough Adderall and other stimulants. This continuing dislocation has forced many of the 40-plus million ADHD patients nationwide to encounter refilled delays or depleted pharmacy inventories and importantly, we continue to hear of these issues daily still. Without adequate access to these important meds, this large patient group continues to suffer from an inability to manage their ADHD symptoms, and this really wreaks havoc on a patient’s day-to-day functioning.

Overall, eight drug manufacturers have reported shortages of amphetamine, which also means that other major ADHD medications are now in short supply after prescribers turn to other treatment options for their patients. And again, some manufacturers have discontinued their stimulants altogether. As these shortages have continued, our team has done an exceptional job meeting the demands of patients having maintained supply to meet the growing demand for both Adzenys and Cotempla. As a reminder, Adzenys, the only approved extended release ODT and amphetamine for the treatment of ADHD is approved as bioequivalent to Adderall XR. So our brand is well positioned to continue to capture additional share as the amphetamine mixed salt shortage remains.

Cotempla is the only approved extended release ODT methylphenidate for the treatment of ADHD, which competes against Concerta and other methylphenidates and again, those products are experiencing shortages and discontinuations. We expect the ongoing ADHD supply situation to likely continue for the foreseeable future in some form or fashion. And with that, this creates a continuing opportunity for more and more patients and prescribers to get experience with Adzenys and Cotempla such that once they’ve tried our medicines in conjunction with an improved patient experience through Aytu RxConnect, they’ll continue on these meds. And I should say, as it relates specifically to RxConnect, that it’s not enough to simply have better products that fill a clinical need, which by the way we believe ours are and do.

Today you need to couple your unique products, features and benefits with an improved experience for patients, caregivers, clinicians and their staff. One that brings predictability, consistency, transparency, convenience and cost effectiveness. And with Aytu RxConnect, that’s what we bring. And that’s how we’re winning with our products in today’s competitive environment. Our Aytu RxConnect patient support program stands alone as truly best-in-class and when clinicians and patients experience it, they like it. The growth we’re seeing with our ADHD brands has been a testament to our manufacturing team’s focus on meeting increased demand while managing the transition to the CMO, as well as our commercial team’s strong execution and ability to showcase the benefits of our brand, and of course, our innovative Aytu RxConnect patient access platform.

We believe more growth is in store for the ADHD brands given the ongoing ADHD stimulant disruptions. Our sales force’s execution increases in new ADHD diagnoses and the continued refinement of our commercial tactics that complement and surround Aytu RxConnect. Within pediatrics, as communicated last quarter, we were impacted by payer changes that impacted net revenue and scripts. Scripts were down 24% sequentially, although importantly, are still up over 2022 levels. However, due to timing of customer ordering, revenues attributable to the multivitamin line decreased more appreciably. Scripts are stabilizing from the payer change and once we’ve worked through the unit shipment slack in the system due to what was in the channel pre-payer change, we expect to get back to growth.

Payer changes are a fact of life in pharma and not something that is unexpected to us or something that we don’t know how to deal with to the contrary. Also, often when we experience a negative change with one payer, we’ll see positive change from another payer that often stands to offset it. We’re seeing that here recently picking up coverage for the multivitamins with a different payer and that is now starting to pay dividends. That is to say we fully expect that we’ll get back to growth. Again, even with the payer impact, our multivitamin Q1 scripts are up over 15% from the fiscal ‘22 quarterly Rx average, and that’s before we’ve begun to realize the benefits of many of the commercial strategies we’re putting into place. And I’ll remind you, inclusive of the ADHD brands, our overall Rx portfolio was up 13%, from a script count standpoint over the same quarter last year.

We’ve implemented numerous strategies to further penetrate pediatric prescriptions from current writers and broaden our overall prescriber base in both new and existing geographies. Our expectation is for both script and revenue improvement in the pediatrics business to occur in the coming quarters. Again, the largest revenue impact in pediatrics is attributed to the timing of customer ordering and that’s being worked through. Our initiatives to drive long-term shareholder value in the company by focusing on our Rx segment and the planned wind down of our consumer health segment are progressing according to plan. I personally couldn’t be more optimistic about how well we’re positioned. Our Rx segment had its segment adjusted EBITDA remain healthy at $2.4 million for the quarter, which when coupled with the improvement for the wind down of our Consumer Health segment and the discontinuation of our pipeline R&D activities saw our combined company-wide adjusted EBITDA improve by 32%.

Adjusted EBITDA is a critical performance metric as we move forward and I’m happy to say that adjusted EBITDA continues to hold strong with five of the last six quarters positive for the Rx segment and now two consecutive positive quarters company-wide. Our balance sheet remains strong with $20 million in cash at the end of September ‘23 and with a keen focus on driving growth and profitability in our Rx segment, I believe we’re well positioned for success going forward. With that, let me now turn the call over to Mark to run through the numbers and some more detail. Mark?

A scientist in a lab coat holding a vial filled with a blue glowing liquid, representing the clinical-stage biopharmaceutical company’s research in rare diseases.

Mark Oki: Thank you, Josh, and welcome to everyone joining us on this call. Let’s take a closer look at the financials starting with revenue. Net revenue for the first quarter of fiscal 2024 was $22.1 million down compared to the 2023 first quarter of $27.7 million, and directionally where we expected to see revenue given the wind down of the Consumer Health segment and the corresponding revenue decline associated with that. Looking at the segment contributions, net revenue from Rx product sales in the 2024 fiscal first quarter was $17.8 million compared to $18.7 million in the same quarter last year. Our ADHD products logged a 31% net revenue growth to $15.1 million in the 2024 first quarter against $11.6 million in last year’s light quarter.

This continued ADHD sale gains reflected consistent sales force execution, the implementation of numerous commercial strategies, and market share gains related to the ongoing manufacturing and supply issues at large providers of ADHD products. Our quarterly ADHD written prescriptions were up 20% year-over-year and provide a bit of insight into our short-term future revenues. Moving on to our prescription pediatric portfolio, which experienced a 61% decrease in net revenue to $2.61 million in our 2024 fiscal first quarter compared to $6.6 million in 2023. As Josh previously noted, this decline resulted largely from timing-related ordering of our prescription multivitamins following a pair change. If we normalize pediatric revenue to reflect actual prescription demand once the supply chain slack realigns to prescription demand, pediatric Rx driven demand revenue would have been in the $4.4 million range, with a corresponding increase to adjusted EBITDA of approximately $1.5 million.

We are confident that we will be able to return these multivitamin products to growth trends over the next few quarters. And again, even in the face, this time-based revenue impact on multivitamins, we remained adjusted EBITDA positive for the quarter and now have posted two consecutive adjusted EBITDA positive quarters as a company. Adjusted EBITDA is our critical performance metrics, and we’re pleased with our results. As we announced this past June, we are in the process of a wind down of the Consumer Health segment with a focus on improving corporate profitability. For the 2024 first quarter, net revenue from Consumer Health was $4.3 million compared to $9 million in the same quarter a year ago, a decrease of 52%. Our goal is to continue to sell through inventory with a goal of converting inventory to cash and ceasing consumer health operations by the end of fiscal 2024.

Obviously, should a buyer for this segment materialize during the process, then we’d prefer to sell off either a portion of or all of the operations. But as we continue the wind down, the likelihood of any partial or full segment sale decreases. Overall, we expect the segment to be approximately adjusted EBITDA neutral, over the next few quarters into the company’s fiscal year end. As we noted previously, we continue to have a small amount of other prescription revenue both this year and last, and reflects discontinued Rx products which continue to gradually tail off. In the 2024 first quarter, other revenue dropped to $124,000 versus last year’s first quarter of $509,000. As we move forward, we would expect these amounts to continue to decrease and ultimately stop.

Gross margins improved to 67% in the first quarter compared to 65% of net revenues in the quarter a year ago. The 2024 first quarter gross margins were positively impacted as ADHD sales continued to a strong growth, which provided for better overhead utilization at the Grand Prairie facility, along with significantly reduced lower margin consumer health sales. However, even though margins improved year-over-year, gross margins were negatively impacted by the above described decline in our higher margin pediatric products portfolio. As we have commented in each quarter, our business growth — our business gross margin percentages can and do vary both due to both seasonal and other factors. Additionally, we continue to progress with the manufacturing outsourcing of our ADHD products.

A few weeks ago, the company received FDA approval of the Cotempla PAS. This approval enables us to transfer the manufacturing of Cotempla to the company’s third-party manufacturer and follows a similar milestone for Adzenys which received PAS approval this past spring. With both Adzenys and Cotempla PAS approvals now in hand, we expect to begin the initial ramp-up of contract manufacturing of Adzenys and Cotempla in this current quarter. We expect that this production transfer to the contract manufacturer, coupled with our planned exiting of operations at the Grand Prairie, Texas manufacturing facility should allow us to realize enhanced margin improvement in these ADHD products beginning in calendar 2024. While we are focused on enhancing margins, we continue to be mindful of the underlying patient needs.

We are committed to a consistent and orderly transition of production to the new manufacturing facility over the coming months to ensure adequate inventory is available to meet the strong prescription growth experience for both Adzenys and Cotempla. Operating expenses, excluding impairment expense, changes in contingent consideration and amortization of intangible assets were $15 million in the 2024 first quarter compared to $18.5 million in the same period a year ago. This 19% decrease reflects our continued emphasis on cost reductions and the ramp down of sales and marketing expense related to the Consumer Health segment. Research and development expenses were $604,000 in the first quarter of 2024 compared to $1.1 million in the 2023 light quarter.

Net loss for the first quarter of 2024 was $8.1 million or $1.48 per share compared to $701,000 or $0.28 per share for the same quarter last year. The primary factor for this jump was the swing in non-cash expense related to the gain or loss on derivative warrant liabilities, which gyrated from a $2.2 million gain in the first quarter of last year to a $5.9 million loss this year, a result of the increase in our stock price. Even with this quarter’s net loss, we generated a solid positive adjusted EBITDA this quarter of $2.2 million compared to $1.7 million in last year’s first quarter, an improvement of 32%. Cash and cash equivalents on June 30, 2023 were $20 million compared to $23 million in June 30, 2023. We’re comfortable with this capital level and believe that our balance sheet provides us with good foundation to fall through on all of our corporate changes, which we believe will lead us from positive adjusted EBITDA to profitability.

As many of you already know, we don’t give forward guidance. We have slimmed down our product lines and now just focus on our Rx products. We received FDA PAS approvals to transition all of our ADHD production from our underutilized Grand Prairie plant to our outsourced and efficient manufacturing partner. We continue to be excited about how Aytu is positioned for fiscal 2024 and beyond. With that, let me turn it back over to Josh.

Josh Disbrow: Thanks, Mark. Let me just conclude where I started. I’m pleased with the results generated following the initiatives we have undertaken to position Aytu as a growing specialty pharmaceutical company focused on commercializing our novel therapeutics and providing patients with a much improved access experience. We are executing and I’m proud of the work the entire team has done to get us into this strong position. Our ADHD revenue, which represents the substantial majority of our go-forward business, was up 31% and was driven by the commercial team’s strong execution and our ability to effectively leverage our innovative Aytu RxConnect platform. We have some work to do to fully address the impact from the payers surrounding pediatrics and we’re addressing it in real time.

But as PEDS represents a relatively small component of our overall business and had a comparatively small impact on our overall business, particularly when you put the revenue decline in context around order timing and the normalization as we’ve spoken to. And again, even with that order timing issue and the corresponding revenue impact, we’ve reported our second consecutive quarter of company-wide positive adjusted EBITDA. And again, the fifth of the last six quarters of positive adjusted EBITDA specifically for our Rx segment. With 20 million in cash on the balance sheet, initiatives in place to drive script growth and continuing improvement in our gross margin and OpEx and you couple that with a wind down of our consumer product segment that’s happening now, I believe the profile of Aytu is becoming increasingly attractive to investors.

I mentioned this last quarter, but it bears repeating. I understand the path here at Aytu has not always been straight, as it’s not for almost every company. And not every quarter is going to set records, but in the long run, and as we execute on all the initiatives we’ve described, we will position Aytu as a strong operating company that drives meaningful cash flow. To that end, our focus and our objectives are clear, and we believe that there’s a great opportunity going forward to drive shareholder value. We’re laser-focused on that. I appreciate everyone’s support and commitment to the future of Aytu and I thank you for your time today. With that, I’ll be happy to answer any questions.

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Q&A Session

Operator: Thank you. At this time, we will be conducting a question-and-answer session. [Operator Instructions] The first question comes from Naz Rahman with Maxim Group. Please proceed.

Naz Rahman: Hi, everyone. Thanks for taking my question and congrats on all the progress. I actually have several questions if you don’t mind. So first, I just want to start on the pediatric business, the multivitamin business specifically. Obviously, you said that you have the one-time impact due to payer changes, and you expect to return to growth. But when you return to growth, do you expect to return to like the same level of sales you were previously seeing like in the $6 million, $7 million range? Or do you just expect to return a growth from these levels?

Josh Disbrow: TBD now is, but I would say generally speaking, I’m optimistic about at some point in the future being able to get back to where we were. And as I mentioned, sometimes when one payer change happens to the negative, you can get a positive on the other and we did see some improvement in an area outside of kind of our traditional footprints, so to speak, and that’s starting to pay some dividends. So I’d like to think, and I think we collectively believe we can kind of get back to those historical levels, maybe not immediately, maybe not in the next quarter or two, but I think over the long term, yeah, I think we can get back to that being kind of in that range. It’s not going to maybe be, again, in an immediate context, but pretty optimistic that we can grow our way through it.

I mean, look, I mean, fiscal ‘23, which for us ended back in June, was a significant growth year. And so even with this sort of drawback, so to speak, I mean, we’re comfortably kind of at fiscal ‘22 levels. And so again, how quickly do we get back to those levels? We need to continue to work through some things. And again never sort of a straight line. These changes, while you don’t necessarily anticipate them in real time, you anticipate them in general. And the team really has done a good job putting a lot of things in place to get us back to growth. So I’m optimistic that in the long run, yeah, we can get back to those types of levels.

Naz Rahman: Thanks. That was very helpful. Now on the ADHD, I actually have several questions here if you don’t mind. The first thing is on a high level, you talked about your script growth. Could you provide some more color and commentary on your prescriber growth? How much are you seeing additional prescriber growth versus just increase in scripts written per prescribers?

Josh Disbrow: We’re seeing both, Nas, which is great, a real sign of health across the business. We’re seeing new prescribers come in at higher levels. I mean, that really started, essentially earlier part of this calendar year, really actually at the beginning of the calendar year, we saw a significant uptick in the number of prescribers and we’re seeing those prescribers increase their prescribing as they get more comfortable and then we are seeing existing prescribers go broader as well as not just in response to the shortages but as they’re getting more comfortable with RxConnect and the conveniences that offers. So we’re really — it’s great to see it’s a combination of both which is really what you want to see. So yeah, it’s and I don’t necessarily quantify it other than to say it’s sort of healthy, healthy parts, not necessarily equal parts, but healthy parts, sort of both components of going deeper within the current prescribers and then, of course expanding into new prescribers.

And that applies to areas where we have sales representation within our footprint as well as in areas outside of our footprint, which is encouraging to see that prescribers are finding their way towards Adzenys, Cotempla irrespective of any direct contact and that’s by virtue of some of the indirect non-personal things that we’re doing to bring in prescribers outside of our established geographies.

Naz Rahman: Got it. That was very helpful. So due to the shortages, relatively recently, there were members of Congress that were, like, inquiring or investigating both the DEA and the FDA regarding the shortages. I believe the FDA and the DEA released a joint letter that they found or stated that manufacturers only sold 70% of their allocated quota and there was about a billion of additional authorized doses that were in produced or shipped. Do you have any comments or thoughts around what’s going on here in terms of these inquiries and what also like shields Aytu from these issues or does it?

Josh Disbrow: So yeah, a lot to unpack there, Naz, and I appreciate the question. You’re exactly right. There’s been a significant amount of scrutiny to both the FDA as well as the DEA around this issue. And what I’ll tell you is the other companies that we’ve spoken to do not have any excess quota. They’re not sitting on any excess quota. There may be some manufacturers that are not being forthcoming, but I can tell you, as it relates specifically to us at Aytu, we’re using every bit of quota that we request. We’re obviously going back and getting incremental requests for additional quota, and we’ve been successful in getting that. So we’re using every single bit that we can get allocated to us. And really the genesis of it is pretty straightforward from my perspective, Nas.