Aytu BioPharma, Inc. (NASDAQ:AYTU) Q4 2023 Earnings Call Transcript

We’ll be opportunistic, we’ll be thoughtful, and we’ll do what’s right for the business as it relates to whether to contract and if so, to what degree. But we have had conversations with payers. It’s to some degree a result of the movement of our products. It’s also an artifact of sort of the landscape within ADHD. And some of the products going generic, some of the products potentially approaching the loss of exclusivity, we think they may present some opportunities to engage with payers. But we certainly are not at the point of making any decisions with respect to engaging in a formal sense. Payor rebating is an art unto itself. Sometimes you don’t get what you pay for. And so we want to be very conscientious about how we think about contracting, if at all.

What’s great here is we really have underlying the entire portfolio, RxConnect, and I like to describe RxConnect as a sort of underwriting we do ourselves. We can take payers really out of the mix entirely by virtue of the fact that we guarantee a maximum co-pay. For example, with the ADHD brands, if a patient has commercial insurance, those patients will pay no more than $50, irrespective of whether they met their deductible, whether it’s a prior authorization, a step edit, and so forth. It is a guaranteed no more than $50. And we’ve got a similar program set up with the pediatric product, particularly with the multivitamins. So we can work with the payers, we can work alongside of them, we can work around them in the event that they have negative coverage policies or don’t have our products on formulary.

And even in the events when they do have them on formulary, if they for some reason get removed or there’s a block that gets put in place, we can really step around all of that through the dynamics of RxConnect. So that having been said, I think we’ve given ourselves good leverage by virtue of the momentum we’re creating in the field with the ADHD brands and the pediatric brands and would expect to continue to have fruitful discussions with payers, and we’ll have the ability to decide how we want to take those discussions.

Naz Rahman: Thank you, that was very insightful. And my last question, so obviously your growth has been driven by stimulant shortages. Could you sort of give us some color on, I guess, your confidence on being able to successfully obtain API on getting acceptable or sufficient quota from the DEA so you can continue to service your ADHD operations?

Josh Disbrow: Yeah, in short, Naz, we’re very confident. Neos in all of their history, and now with our combined history following the acquisition of Neos 2.5 years ago, we’ve never stocked out. We’ve always been successful in securing the API that we need even in the face of increasing demand. It is iterative. The DEA is willing to work with you. It is not a, here’s your annual supply and you’ll never get any more. We in real time, certainly monthly and in some cases more frequently than that, will go back and request additional quota. We’ve got the demand trends. They look at our prescription data. They look at sales to customers. And they can see very clearly that these are real sales going to real customers, and there’s a real need.

So we’ve been able to secure API. We just got new API released from the DEA here recently. Our contract manufacturer has already secured their initial — some initial allocation of API on Adzenys since we’ve begun to shift some manufacturing to them. So we’re comfortable. People have asked us, look, if you continue to rise at this level, can you continue to satisfy the level of demand that’s resulted from this gap in the market? And the short answer is yes, we believe we can. These products have collectively less than 1% of the market. So it’s a relatively small piece when you look at the aggregate quota that gets allocated out there across all stimulant brands and generics. That having been said, if we only “got to” 2% of the market, that would obviously double our revenues.

That’s still a relatively small piece of the overall pie. And the DEA has been very collaborative. One little anecdote I’d like to share is we — our Vice President of Manufacturing and Supply, her spouse is employed by the DEA, has been an agent for many, many years. There’s an element of comfort, familiarity, and certainly not to suggest that that helps us necessarily in any unique way. But certainly there’s a level of familiarity with the people that are there in the Texas facility granting quota. We just had a very successful review by the DEA actually over the last couple of months. So, relationship is good there and certainly feel highly confident in being able to continue to secure more and more quota.

Naz Rahman: Thank you, that was very helpful. And thanks for taking my questions. And once again, congrats on the record year.

Josh Disbrow: Thanks very much, Naz.

Operator: Thank you. [Operator Instructions] The next question is coming from [indiscernible] from Stonegate Healthcare. Alan, your line is live.

Unidentified Analyst: Hi, thanks for taking the question and congratulations again on your performance this year with Rx and pediatric sectors. My questions are surrounding your transition away from the Consumer Health segment and R&D, as well as your plans to outsource manufacturing. Could you expand on what sort of impact these changes will have on margins and revenues over the next year?

Josh Disbrow: Yeah, good question. Mark, you can jump in here. But generally speaking, most of the drag on our margin has been on those two pieces as we spoke to significant negative EBITDA on the Consumer piece over the trailing 12 months and actually higher when you go back to the trailing 24 months. And then R&D was a significant drag as well and, Mark, maybe you can put some numbers to it, but it’s — if you look at the company on a go-forward basis and really treat Aytu as the Rx segment, you’re looking at a significantly EBITDA positive company on a go-forward basis. The Rx segment had positive net income from operations or positive income from operations when you look at it from a P&L perspective. And so those — it’s going to be addition by subtraction.