Sign in

You're signed outSign in or to get full access.

Aytu Biopharma - Earnings Call - Q2 2025

February 12, 2025

Executive Summary

  • Q2 FY25 revenue was $16.2M, down vs Q2 FY24 ($18.7M) and slightly below Q1 FY25 ($16.6M); gross margin fell to 66% on high-cost ADHD inventory from the shuttered Grand Prairie facility.
  • Net income was $0.8M (basic EPS $0.13; diluted EPS $(0.26)) driven by a $3.0M derivative warrant gain from a lower stock price; adjusted EBITDA was $1.3M (7th straight positive).
  • ADHD revenue was $13.8M (down YoY; up 16% sequential on an adjusted basis excluding a $3.3M Q1 one-time) and Pediatric revenue rebounded to $2.4M (+86% QoQ), with first simultaneous sequential RX growth in both portfolios since late 2022.
  • Management reiterated at least $2M annualized OpEx savings, gross margin normalization toward low-to-mid 70% as high-cost inventory sells through, and continued pursuit of tuck-in BD; expects revenue and adjusted EBITDA growth from current levels as it strives for positive cash flow.
  • Consensus estimates (S&P Global) were unavailable at query time, so we cannot quantify beats/misses this quarter.*

What Went Well and What Went Wrong

What Went Well

  • Pediatric portfolio re-accelerated: net revenue rose 86% sequentially to $2.4M as coverage and distribution broadened; management cited organic drivers, not one-time effects.
  • ADHD pricing/gross-to-net improved sequentially: on ~99k scripts, ADHD net revenue was $13.8M vs an apples-to-apples $11.9M in Q1 ex one-time rebate, reflecting stronger net price realization.
  • Profitability optics improved: seventh consecutive quarter of positive adjusted EBITDA ($1.3M) and second straight quarter of net income, supported by cost controls and a $3.0M derivative warrant gain.

What Went Wrong

  • Gross margin compression to 66% (from 78% YoY) due to higher-cost ADHD inventory as production transitioned out of the Grand Prairie facility; normalization expected after sell-through.
  • YoY revenue decline to $16.2M (from $18.7M) driven by lower ADHD sales YoY amid normalized stimulant supply and tough comps, partially offset by Pediatric growth.
  • Operating income swung to a $1.7M loss from $3.1M income in Q2 FY24; adjusted EBITDA declined YoY to $1.3M from $5.5M as lower revenue and gross margin pressure outweighed OpEx savings.

Transcript

Operator (participant)

Good day, everyone, and welcome to the Aytu BioPharma Fiscal 2025 Q2 earnings call. At this time, all participants have been placed on a listen-only mode. If you have any questions or comments during the presentation, you may press Star one on your phone to enter the question queue at any time, and we will open the floor for your questions and comments after the presentation. It is now my pleasure to turn the floor over to your host, Robert Blum. Sir, the floor is yours.

Robert Blum (Managing Partner)

All right. Thank you very much, and good afternoon, everyone. As the operator indicated, during today's call, we will be discussing Aytu BioPharma's fiscal 2025 second quarter operational and financial results for the period ended December 31, 2024. Joining us on today's call is Aytu's Chief Executive Officer, Josh Disbrow, and Ryan Selhorn, the company's Chief Financial Officer. At the conclusion of today's prepared remarks, we will open the call for a 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 teleconference numbers and conference ID provided in the press release issued earlier today or by utilizing the link on the company's website under Events and Presentations. 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, 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, let me turn the call over to Josh Disbrow, Chief Executive Officer of Aytu BioPharma. Josh, please proceed.

Josh Disbrow (CEO)

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 script 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 broaden distribution and dispensing. We are 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 $2 million in 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 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 all 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 towards 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 million in Q2 of last year.

We went into great detail last quarter discussing the commercial rebate 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 multi-year 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 had been carrying a gross to net accrual. We resolved that last quarter, and the resolution resulted in a one-time increase in net revenue of $3.3 million during the first quarter and a reduction of that liability we had been carrying on our balance sheet for the past few years. If you backed out the $3.3 million from Q1's net revenue, ADHD net revenue would have been $11.9 million.

The $13.8 million we just reported in Q2 on approximately 99,000 scripts compares very favorably with the $11.9 million in net revenue on also about 99,000 scripts in Q1. Our per-script net price actually increased sequentially. ADHD net revenue was up 16% sequentially on an apples-to-apples basis, excluding the one-time item. This highlights an improvement in our gross to nets, 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 that impacted the supply of products like Adderall XR and other ADHD stimulant meds. As I've discussed, fortunately, Aytu's supply was never impacted, and we therefore realized 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're above the baseline 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 stopped 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. 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 of the last two quarters and the $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 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 a 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 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 payment, whether that's in the form of a copay, whether they're paying cash, or whatever the case might be. The U.S. 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 their 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 ensure adequate stocking of our products and to make them more available. 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 includes everything up to including a copay not to exceed $50 for patients that are commercially insured, and when covered, the copay, 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.

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 and affordable. It also helps the physician 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. It solves this significant issue today where you can walk into your area chain pharmacy and next month you may pay a different price than you paid this month, and that's the way PBMs have designed it to be opaque and to make it very challenging for patients.

With RxConnect, we have freed up physicians to prescribe our brands without fear of the dreaded callback from a pharmacy saying either we do not have it, we cannot get it, or even worse, the parent of a patient calling back saying that was a ridiculous, crazy high copay that was way beyond what I expected or beyond 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. That is why with RxConnect, we believe at Aytu we can succeed. For us, success is winning for prescribers, for patients, and for pharmacies alike, and that is what we are working to achieve for these stakeholders every single day.

The Aytu RxConnect program that envelops our products really is the game changer that enables these products to stand apart, 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 smallish yet valuable assets that maybe don't fit at a particular organization and have become non-strategic.

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 can bolt on and that fit within our commercial footprint and our low cost. Hopefully, as we 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 detail, after which I'll provide a few closing comments and we can take your questions. Ryan.

Ryan Selhorn (Senior VP, Finance and Controller)

Thank you, Josh. Before we look at the numbers, I want to try to give a big picture overview of where the company stands financially as we enter the calendar 2025 and are more than halfway through our fiscal 2025 year. The company has made huge strides both operationally and financially in the last few years, but it's still a bit difficult to see our progress because of some of the lingering noise. If you will indulge me as well, I would like to remind our stockholders and listeners of our achievements over the last few years and provide a glimpse of where we think we can go in the not-too-distant future. To get to this point, we shuttered our clinical development program, saving $20-$30 million in R&D expenditures. We powered down and ultimately sold off our cash-consuming consumer health business.

We spent over two years methodically working through the regulatory processes, demonstrating bioequivalence of our ADHD brands, and ultimately outsourcing the manufacture of these products from our underutilized and expensive Grand Prairie facility. In conjunction with these things, we continued to cut overhead while still investing in the growth of our business. If you look back to two years ago, for the six months ended December 31, 2022, we incurred $15.3 million in G&A expenses and today have reported $9.6 million for the same period in fiscal 2025, a reduction of 37%. Additionally, we incurred sales and marketing expenses for the six months ended December 31, 2022, of $20.7 million compared with the current six-month period of $10.9 million, or a 47% reduction for a combined reduction of $15.5 million, or approximately $31 million annualized. This represents a reduction across SG&A of 43% on an annualized basis.

These strategic changes allowed us to generate positive adjusted EBITDA and keep our cash level steady, providing us with flexibility and optionality. More importantly, as Josh mentioned, these changes have teed us up both to grow and ultimately generate free cash flows. The noise I mentioned a moment ago includes things like working through higher-cost ADHD inventory manufactured at our now-shuttered Grand Prairie facility, one-time restructuring expenses related to our optimization, accounting reclassifications, and the reinvigoration of our pediatric Rx business. As we continue to work through these items over the next few quarters, our expectations are that we will see ADHD sales once again rise with the market growth, see pediatric sales regain lost sales, and build out revenue in new territory, see gross profit margins continue to improve toward the low to mid-70% range, and see operating margins reflect our reduced headcount, leaner management structure, and outsourced manufacturing.

Let's now move to the numbers, and please note that our second fiscal quarter financial results are detailed in both our press release and Q2 fiscal 2025 Form 10-Q that we issued earlier today. Our second quarter net revenue was $16.2 million, down from $18.7 million in the year-ago second fiscal quarter. The ADHD portfolio net revenue decreased 17% to $13.8 million versus $16.6 million in Q2 fiscal 2024, reflecting normalization of the ADHD stimulant supply chain following market shortages through much of fiscal 2024. On a sequential basis, as Josh touched on, excluding the payer resolution we entered into last quarter, which resulted in a one-time increase in our Q1 fiscal 2025 net revenue of $3.3 million, ADHD net revenue increased 16% sequentially. On the pediatric side, net revenue was $2.4 million versus $2.1 million in Q2 of last year.

As Josh noted, we are pleased with our pediatric results, which showed a rebound year over year. I will also note that the sequential quarterly numbers are up approximately 86%. This pediatric net revenue improvement demonstrates the continued rebound of the product group from the year-ago comparable quarter when the payer changes that impacted scripts began. The turnaround was first visible last quarter as the sales and marketing programs we implemented gained steam, reflecting both a recapture of lost share and our expansion into new geographies. Gross margin for the second quarter was 66% compared to 78% in Q2 of last year. As I noted last quarter and just a moment ago, the outsourcing of production out of Grand Prairie to a contract manufacturer is creating noise in the current quarter gross margin, which will most likely continue for the next several quarters.

As a reminder, as a part of the switch to contract manufacturing, we needed to reduce our in-house production while simultaneously ramping up ADHD production at the contract manufacturer. Unfortunately, this type of manufacturing handoff decreased its gross margin on ADHD inventory manufactured in Grand Prairie as fewer units were manufactured and therefore fewer units had to bear greater amounts of facility and associated overhead costs. Thus, these higher inventory costs now moving through the channel reflect the planned underutilization of Grand Prairie facility as we transitioned ADHD product manufacturing from inside to outside sourcing. We anticipate incurring the higher cost of sales until we have sold through this higher-cost internally manufactured product. This process is expected to be completed in the coming quarters, and the more normalized gross margin should be evident going forward.

In addition, we expect gross margins to benefit from the rebound in pediatric sales, which traditionally have carried the highest margins in our product mix. Looking at the quarter's operating expenses, excluding amortization of intangible assets and restructuring costs, we were down slightly to $10.2 million from $10.5 million last year. The decreased operating expenses is a result of the continued cost reduction efforts and the improved operational efficiencies we have discussed. Please remember that the OpEx number I just mentioned from a year ago excludes this consumer health business as it has been moved to discontinued operations. If you were to look at the actual OpEx from the year-ago quarter, the savings are even more pronounced. Put differently, looking at just the G&A on a trailing 12-month basis, excluding the consumer health business, we have enacted over $7 million in savings.

On the sales and marketing side, it is an additional $2.5 million for a total of $9.5 million in real savings, which ultimately lowers our revenue break-even level substantially. Net income for the second quarter of fiscal 2025 was $0.8 million, or 13 cents net income per share basic and 26 cents net loss per share diluted, compared to a net loss of $0.2 million, or 4 cents net loss per share basic and diluted in the prior year period. The fiscal 2025 second quarter results were impacted by $3 million of derivative warrant liability gain due primarily to the decrease in the company's stock price compared to a derivative warrant liability loss of $0.6 million in the second quarter of fiscal 2024. For the quarter, our adjusted EBITDA was a positive $1.3 million against last year's quarter of $5.5 million.

A major change here is the impact from the gross margins discussed due to the exit of the manufacturing facility, as well as the decrease in the ADHD net revenue. A full reconciliation of adjusted EBITDA is included in the press release. Turning now to the balance sheet, cash and cash equivalents at December 31, 2024, were $20.4 million compared to $20.1 million at September 30, 2024. We continue to maintain our receivables at a healthy level while we look to optimize our inventories via the timely deliveries from our various outsourced manufacturers. On the liability side of the ledger, we are in full compliance with all our debt covenants. Also, as a reminder, our term note amortizes monthly, so we continue to pay down our outstanding principal balance, which has decreased to $12.1 million as of December 31, 2024.

As we have commented on periodically, our business's gross margin percentages can and do vary due to both seasonal and other factors. I want to remind all listeners that while we are reviewing the second fiscal quarter 2025 results, we are currently operating in the third fiscal quarter, which, of course, began January 1 with the new calendar year. Many, if not most, planned participants today, as well as the consumers of our products or their parents, have had their annual insurance deductibles reset starting at the beginning of the new year. As such, we expect to experience a greater use of our Aytu RxConnect price protection program in Q3 fiscal 2025, which historically lowers our gross-to-net margin.

Please remember that this value add is part of our normal seasonality and part of our business model, and those gross-to-net adjustments improve throughout the calendar year as families meet their deductibles and our need to provide the out-of-pocket backstop subsidies decreases. With that, let me turn it back over to Josh.

Josh Disbrow (CEO)

Thanks, Ryan. Let me just wrap things up by saying that we have successfully implemented a multi-year strategic realignment to focus on a profitable prescription business and leverage the unique capabilities of a now streamlined organization. These changes have resulted in the growth of our novel commercialized prescription therapeutics while also driving positive adjusted EBITDA and approaching profitability. With positive operational trends in place, we remain focused on seeking opportunities to leverage our commercial infrastructure in the Aytu RxConnect platform while we pursue additional in-licensed or acquired products. We continue to expect net revenue and adjusted EBITDA growth from current levels as we strive for positive cash flows. I'm pleased with the significant progress made and look forward to the continued execution of our strategy in the quarters and years to come.

As always, I'd like to thank the entire team at Aytu for their hard work and dedication in delivering for both patients and for stockholders. I'm very proud of the progress that we've made collectively. With that, thanks to everyone participating on today's call. We'll now be happy to answer any questions.

Operator (participant)

Certainly. Everyone at this time will be conducting a question-and-answer session. If you have any questions or comments, please press Star one on your phone at this time. We do ask that while posing your question, please pick up your handset if you're listening on speakerphone to provide optimum sound quality. Once again, if you have any questions or comments, please press Star one on your phone. Your first question is coming from Naz Rahman from Maxim Group. Your line is live.

Naz Rahman (Stock Analyst)

Hi everyone. Congrats on the quarter, and thanks for taking our questions. I have a few. I'll first just start on the ADHD franchise. It looks like the franchise on a quarterly basis has been hovering around this $14-$15 million quarterly rate for the last several quarters. Seeing how the similar shortages or the effect of similar shortages on meal rating somewhat, do you think the franchise could return to generating $16-$17 million anytime soon? What do you think is the pathway or their strategy to get there?

Josh Disbrow (CEO)

Yeah, thanks, Naz, for your question, and appreciate you being on. We absolutely do anticipate growth, and the notion of $16-$17 million a quarter we think is very feasible. Certainly, there has been some regression to the mean, so to speak, as the market has normalized. If we just keep up with market growth and just gain any share, we'll be back into kind of that $16-$17 million range. Confident about that and equally confident about the pediatric products continuing to grow and get back significantly closer to where they were prior to some of the payer changes.

Naz Rahman (Stock Analyst)

Got it. That was helpful. On the pediatric business, a few questions here. The first one is, obviously you're seeing growth again in the peds business, but were there any one-time effects in the second quarter or any outside orders or any outside effects you saw in the second quarter? In terms of products, which product did you see have the largest impact in the quarter?

Josh Disbrow (CEO)

Yeah, good question. No, no one-time effects. This is organic. We can look at prescription growth that corresponds pretty well with our net revenue increases, some variability in gross to net, as you know, just based on seasonality and various factors. Yeah, we're seeing good old-fashioned organic growth as a result of these initiatives that we put into place. In terms of the largest driver of that, the antihistamine franchise is the largest driver of the growth. In fact, when you look at Karbinal ER, for example, it's at the highest level of prescription since all the way back in Q2 of 2024, so essentially the better part of a year plus the Karbinal ER franchise has not seen that. Pediatric multivitamins, we believe, have certainly bottomed out.

While they haven't grown back to where we'd like them to be, certainly I think we've seen bottom and have started to kind of move back up. Yeah, Karbinal ER is driving most of that growth back.

Naz Rahman (Stock Analyst)

Got it. Continuing on the peds, I believe in your prepared remarks, you said you expanded coverage, including state coverage. Could you talk a little bit about the dynamics in terms of Medicaid coverage in different states? Are you seeing, I guess, the same levels in reimbursement or different types of frictions in all the additional states you expanded to and how you're working through that process?

Josh Disbrow (CEO)

Yeah, happy to. When we say we picked up coverage, we have picked it up on a pretty broad-based sense. Certainly commercial as well. When you look at the state payers, the dynamics are distinct, but we do not actively seek state-level contracts. We have a national CMS rebate agreement, as most companies have. Based on just some of the strategies we have employed, we have been able to get relatively broad-based coverage. Each state kind of makes their own decision in the context of what products they pick up, how they treat brands, how they monitor and manage those. What I will say prior to the payer change, our Medicaid coverage was relatively limited and very concentrated in really just a couple of states where we concentrated most of our sales efforts.

Following some of these changes that we put into place, we have multiplied the coverage and the number of states that have the antihistamine franchise now covered. In terms of the rebates, in terms of the percentage deductions back to the states, they're all the same, essentially. We don't have any supplemental rebates in place with any particular state that drives the gross-to-nets down. We are able to actually have pretty healthy margins on that Medicaid reimbursed business. The fact that we have diversified so much more and we're in so many more states now than two, we really are significantly less reliant on any one state continuing to cover it at the same way. When I say that, I mean covering it without, say, prior authorization, which is often the case with brands.

In a good handful of states, we have open coverage without any requirements for step edits or prior authorization. Excited about that. We're really just beginning to scratch the surface in some of the states where we hadn't been before. As I mentioned in my prepared remarks, we've shifted some resources. We put sales representatives into states where, again, we picked up coverage. We've added the antihistamine franchise into their, what we call, POA plan of action, such that they are now responsible for promoting Karbinal ER. I think we're at the early stages. Frankly, this growth is coming at a time when we're really out of season. We're not even out of winter yet. We expect good things as we head into the spring allergy season.

Naz Rahman (Stock Analyst)

Got it. That was helpful. During your prepared remarks, I believe you said you expect to have an additional $2 million in cost savings. I just want to clarify that statement. Where is that additional $2 million coming from, or is that $2 million the savings you extracted previously?

Josh Disbrow (CEO)

No, we would expect that, and Ryan, please jump in here, but we would expect that on top of what has generally been realized and start to realize some of that here in this current quarter in March. That is $2 million kind of on an annualized basis. That is largely coming out of G&A. Really think of that as a quarter, $500,000 on a quarterly basis, kind of starting in and around this quarter and going out from there. Ryan, if you have anything to add to that, feel free to jump in.

Ryan Selhorn (Senior VP, Finance and Controller)

Right. Now, this is basically the result of some of the actions that we've taken in this past quarter and the second quarter with some additional headcounts from G&A and kind of slimming down some of the contracted services that we have. That is kind of where we'll start seeing the benefit going forward into Q3 and Q4.

Naz Rahman (Stock Analyst)

Got it. I guess I'll ask one last question. On the business development front, could you sort of provide more color on where you are in the process in terms of a potential tuck-in or larger acquisition? I guess where are you guys in terms of talk, and what have been the gating factors to potentially closing a deal?

Josh Disbrow (CEO)

Yeah, what I'll say, Naz, is in active discussions and pretty excited about some opportunities as we kind of take the next step with some of these parties. I'll caveat that with, look, deals take time, and they're unpredictable all the way to the 11th hour and into signing day. You continue to say they're never done until they're done. We are, I would say, in active discussions under CDA and certainly at the point of sort of modeling these opportunities. What I'll say further to that is we're looking at a cross-section of opportunities across CNS/psychiatry and in pediatrics, understanding, of course, we touch both areas. We're looking initially and most preferentially at opportunities that we think we can secure with small or no upfronts. Those are difficult to sometimes pull off, but we're optimistic that we may be able to do that.

We obviously are looking at things that we think have good upside, and we'll be creative, of course. That having been said, we're not in a position to take big dollars off the balance sheet to go pay big upfronts. We want to be open-minded for the right types of opportunities. We're in active negotiations. Excited about what we have in our sights. I can't say there's anything imminent in terms of any kind of an announcement, but certainly at a point of bringing in internal resources to really start fulsome evaluation of these opportunities. Don't want to put a timeline on it. Hard to say exactly when that could happen. Happy to say that I think the environment for the types of things that we're looking at is improving. Yeah, we're optimistic that maybe we can get something done here.

Naz Rahman (Stock Analyst)

Thanks for taking my questions. Once again, congratulations on the quarter.

Josh Disbrow (CEO)

Thanks, Naz.

Operator (participant)

Thank you. Once again, everyone, if you have any questions or comments, please press star, then 1 on your phone. Please hold while we poll for questions.

Robert Blum (Managing Partner)

Matthew, while we wait to see if there's any further questions, we have just a couple of offline questions. I think that Naz didn't yet hit on Josh and Ryan, so I'll just bring a couple of these up here. First off, any updates on some of the legal issues that were mentioned on some of the earlier calls?

Josh Disbrow (CEO)

Yeah, thanks, Robert. Yeah, I'm happy to say for the first time in a very long time that all of the shareholder litigation that would have started several years ago is now behind us. As was mentioned and footnoted in the 10-Q, both the Witmer class action suit as well as the Revive Investing case in which Aytu was named as a nominal defendant, they've been resolved, one of which was really settled for some governance changes, which we've discussed in the past, and payment of attorney's fees. The most recent one, the Revive Investing case, went through a jury trial and was found in favor of the defendant. That case has reached a final verdict pending any appeals, which we don't think is realistic. Happy to say on that front that we are that we're sort of finished with all those matters.

Robert Blum (Managing Partner)

Okay, great. Ryan, perhaps this one's on your side, and I think Naz touched on it briefly, but maybe just expand on in terms of a go-forward expense level basis. You mentioned the additional $2 million in savings, but maybe expand upon that to extrapolate what sort of the go-forward expense level looks like.

Ryan Selhorn (Senior VP, Finance and Controller)

Yep. Happy to do so. Yeah, this will piggyback off of Naz's question. Obviously, our management team is very focused on controlling the future operating expenses, especially those that do not impact the top-line revenue results. We believe we have finally completed all the material costs associated with our restructuring and optimization plans. Going forward, I do not anticipate any material additions to the restructuring expense line in our financials as we have had in the previous quarters. Additionally, with the final headcount reductions that we made last quarter, I do expect to see some additional benefits on our operating expense level in Q3 and Q4. To provide a little bit of perspective, we reduced net headcount by 12 individuals just at the tail end of the second quarter, which will definitely impact the future quarters going forward.

Additionally, there's been a few remaining contracts related to our previous pipeline that have been finalized in early Q3. More savings there as well. Hopefully that expands on kind of the overall savings. I'm confident that the third and fourth quarter will kind of demonstrate a true optimized operating expense level that should allow us to grow the top-line results without much incremental costs, especially at the G&A level.

Robert Blum (Managing Partner)

Okay. Very good. Fantastic. Ryan, Josh, it doesn't appear as though we have any more questions on the live portion of the call. Josh, I guess I'll turn it back over to you for any closing remarks.

Josh Disbrow (CEO)

Great. Thanks, Robert. Thanks, Naz, for your questions. Thanks to everyone for your participation on today's call. Again, as always, I thank the entire Aytu team for their hard work and all they're doing to help us get in this position to help deliver for patients and for stockholders. Reiterate the fact that I'm very proud of what we have accomplished. Really excited about the future, particularly as some of these opportunities that I loosely referred to continue to sort of percolate out there. Thanks again for your participation on the call. We look forward to sharing our results with you next quarter. Until that time, have a good evening. Thank you again.

Operator (participant)

Thank you. Everyone, this concludes today's event. You may disconnect at this time and have a wonderful day. Thank you for your participation.