Okay, our next presentation is coming from Aytu BioPharma. Presenting from the company is the Chief Executive Officer, Josh Disbrow. Josh, please proceed.
Thanks, Robert. Thanks, everyone, for being here. Thanks to Planet Microcap for having Aytu to the conference. Looking forward to sharing with you some of the latest that we've undertaken here. As Robert said, Aytu BioPharma, NASDAQ ticker symbol AYTU. The company was founded just about 10 years ago by myself and two other gentlemen, and we've made a lot of progress, particularly over the last few years, as we've undertaken a fairly substantial transformation to really streamline the organization and focus on what we believe can be the most profitable aspect of our business, which is our prescription business, which is what I'll be speaking about here today. As a reminder, maybe making some forward-looking statements along the way.
If you're hearing the story for the first time, you're certainly catching it, I think, at the right time when we've undertaken some significant endeavors to really right-size the company and focus on our prescription business, which has been really the strongest piece of our business over the last several years. We've completed a multi-stage strategic realignment to do just that, focused on the prescription pharmaceutical business. We've really turned the company around in that we've essentially had a transition from a negative burn in 2021, 2022, to consistently positive EBITDA over the last two plus years, really almost every quarter since the transformation began, we've been posting positive EBITDA.
That transition started, and I should take a step back and say the company perhaps was doing a little bit too much if you look back, say, three or four years ago where we had the prescription business, which has really been our bread and butter from the beginning since our founding. Along the way, we picked up some acquisitions inclusive of a consumer health business. We made an acquisition that brought on the ADHD brands back in 2021. With that came a manufacturing facility, which was quite large. We also endeavored to initiate a clinical trial for a rare disease. Long story short, that was probably a little bit too much for the company to digest and really effectively execute on. Along the way, we essentially cut out R&D. We've now essentially stopped that spending entirely and suspended the pipeline development.
We have shut down the Grand Prairie manufacturing facility that was making the ADHD meds in favor of a contract manufacturer. We sold out the consumer health unit back in the middle of 2025, such that when you look at where the company is today, it is, again, a streamlined, clean, and tidy prescription-only business whose hallmark is very specifically ADHD and pediatric brands. These are brands that compete in large markets. The brands have been growing, particularly in the case of the ADHD brands. Had a little bit of a setback with our pediatric product line, which I'll speak to. All in all, the company is positioned now at $60 million in annualized revenue when you look at over the trailing 12 months and consistent EBITDA quarter after quarter.
One of the calling cards of the company is not just our unique brands in ADHD and pediatrics, but equal parts our patient access program, which we call A2Rx Connect. It's an in-house developed program that enables seamless transactions for a patient getting prescriptions for branded medications, which is not nearly as easy as it needs to be for U.S. healthcare consumers today. We've cut through all the noise that is created by the PBMs and many of the large chain retailers to create a seamless, easy process for patients to get the A2 prescriptions without hassle at a predictable low price month after month after month, as long as they have commercial insurance. We've got a commercial sales team of about 40 sales reps covering most of the major markets in the U.S. and covering the lion's share of the ADHD category.
We also have brought on two licensees outside of the U.S., one in Canada, one in Israel. We are always on the hunt for new acquisitions, one of which we have recently launched with a product called Metadate CD. All along the way, we have maintained or grown our commercial business while reducing OPEX materially year over year over year, such that OPEX is now at the lowest it has been in quite some time. Couple that with a fully outsourced manufacturing play and the company is lean, mean, focused, and really focused on driving growth from here. We would suggest it is a very compelling valuation if you look at us from where we sit today, +$61 million in trailing 12 revenue, consistent EBITDA, 70%+ gross margins.
Enterprise value to EBITDA is quite low, so we think it's an opportunity to take a look, particularly when you consider our cash on hand as of December was just over $20 million. A good time to be looking at the company. Our brands, as I've alluded to, compete in the categories of attention deficit hyperactivity disorder, ADHD, and we have the two only orally disintegrating tablet formulations of stimulants, extended release stimulants, that is. Adzenys XR-ODT is a quick dissolve, dissolves very rapidly in the mouth and lasts a full 12 hours. It competes with the likes of Adderall XR, if you're familiar with that. At a time when patients can intermittently struggle to find their Adderall XR prescriptions at a Walgreens or a neighborhood pharmacy, we've never had a stockout.
We're able to consistently fill the gap that was fairly pervasive about a year ago, has started to abate a bit. What you're seeing now is more of a normalized growth curve for our Zenith product, which competes very favorably in that category. Cotempla is a methylphenidate, also an orally disintegrating tablet. Again, works very quickly. Within an hour, patients are experiencing symptom relief, lasts a full 12 hours. That product competes with the likes of Concerta and Ritalin LA, Focalin LA, if you've heard of those. We have a line of pediatric products that is largely our antihistamine, which we call Karbinal. It's a long-acting 12-hour antihistamine. It's a workhorse that, frankly, works when many others don't. Patients that have tried and failed Claritin and others, Karbinal is great for long-standing allergies, post-nasal drip, and a whole host of things.
We have a line of pediatric multivitamins called Poly-Vi-Flor and Tri-Vi-Flor, which are proprietary branded multivitamins that compete in the sodium fluoride category. These are products that are prescribed in areas that do not fluoridate the water supply. If you have paid attention to any of the news clippings recently, there is an increasing number of municipalities that are opting to no longer fluoridate the municipal water supply. The entire state of Utah, in fact, Governor Cox just signed legislation banning fluoride in the water supply in the state of Utah. That represents a good opportunity for these products as they are used to supplement patients that live in areas where they do not put fluoride in the water supply. We have had consistent growth, particularly on the ADHD portfolio. The large line is the combined ADHD products.
The darker teal is Zenith, and the green is Cotempla. Cotempla has just been a solid workhorse product for us. Competes in a more competitive category, so it's really just been steady, consistent contributor kind of over the last several years. At Zenith, it has been a nice growth product for us. That is important because Zenith competes in the larger of the two markets. There are far more amphetamine prescriptions written than methylphenidate, and this competes very favorably with the likes of Adderall XR. You can see we had a nice little tick up in fiscal 2023, which would have been the 12 months ending June of 2024. That was largely due to a pretty significant outage of Adderall XR generics.
It is nice to see that we are actually still growing out of that, despite the fact that the market has really kind of returned to supply steady state, and there are not really as many shortages. What patients have found is many patients that got switched from, say, Adderall XR to an Adzenys XR-ODT product really liked it. They liked the fact that it is kind of a smoother existence through the day. You do not quite get the hammer that you do in the morning with Adderall XR. Sometimes patients get a real high, and then it really drops off in the afternoon such that they need a booster dose. With our product at Adzenys, it really is steady state, consistent, and smooth throughout the full 12-hour day. Our pediatric portfolio, you can see, really had significant growth.
We did experience a downdraft by virtue of one of the large payers in the tri-state area ceasing payment and reimbursement for pediatric multivitamins, which is sort of a statement unto itself. That having been said, we've begun to put many pieces in place to really enable the pediatric portfolio to get back to growth. We had a really nice quarter. If you look at the December quarter, that portfolio got back to about $2.5 million in net sales. That was up from the preceding quarter of under $1 million. Significant growth quarter to quarter. We haven't yet posted our March numbers yet. We'll release those here in the next couple of few weeks. We'll obviously share what we have there, but we're confident that the pediatric products have kind of bottomed out.
They're now back to some level of growth and at least some level of stability such that all told now you've got a portfolio that's contributing over $60 million over the last 12 months. And that's an EBITDA number in the +$6 million range. But really, if you look at kind of the quarterly EBITDA numbers for the company over the last several quarters, it's between $1 million on the low side and $3 million-$4 million a quarter on the high side. So blended, we still are kind of in the +$8 million annualized EBITDA run rate. So not quite to the point of building cash, not quite cash flow break even.
We believe with continued growth and with the OPEX line coming in where it is now, which we'll show you is significantly lower than where it had been, we think we're positioned now to move into profitability. As I mentioned, revenues in the +$60 million range, the lion's share of that, vast majority of that is, of course, the ADHD product lines, which is, again, Adzenys and Cotempla. Smaller piece of that is the pediatric product lines. That $6.3 million trailing 12 was a bit deceiving because the last quarter was north of $2.5 million in net revenue. We would suggest that $6.3 million is something annualizing closer to +$8 million when you look at last quarter. We are looking forward to posting our results for the March quarter here coming up in the middle of May.
I mentioned one of our hallmarks and one of our calling cards is A2Rx Connect. This is really a second to none patient access program that no other company does and certainly does not do it anywhere close to the way we do it. We truly backstop these prescriptions and essentially serve as the underwriter such that patients that are prescribed our brands and specifically Adzenys, Cotempla, we guarantee that if the physician sends it to a partner pharmacy and they attempt to run it through commercial insurance, those patients will never pay more than $50 for a monthly prescription, which in today's environment is a very, very low copay, competitive with many generics and way more cost-effective than many brands. In some cases, patients, in fact, will pay $0 if their insurance plan covers it.
Patients are guaranteed an out-of-pocket on a monthly basis of no more than $50 and sometimes as low as zero. Our pharmacy partners are incentivized in many, many ways to ensure that they're running the patient's insurance correctly, that they're giving the patient the best opportunity to get that claim covered. They're incentivized to do that in many ways, inclusive of, of course, the economics that they earn on their fill fees. That's all by design. Ultimately, this is supported by a network of about 1,000 pharmacies that are all over the country, even in places where we don't have sales reps present. The partner pharmacies really act as our liaison between us, the company, our sales reps, and to the physician. The physician office enjoys working with these pharmacy partners because they know the patients are going to get high-level care.
This is very high-touch, white-glove service. These are not your neighborhood Walgreens. These are true neighborhood, family-owned, independent pharmacies, small businesses operating in their communities. They want to do the very best they can to retain these patients, give them the best service, ensure the lowest level of copay, and fight against the PBMs to ensure that these patients are getting the best bang for their buck for the insurance premiums they're paying for. We have sales reps that will go out to these physicians, ask the physicians to prescribe our medications, talk about this program. It's a one-two punch. The clinical benefits of these rapidly acting, quick-dissolved medications last a full 12 hours, dissolve in the mouth. You don't have to worry about water. You can take it on the go.
You can get them at a guaranteed price not to exceed $50 per month. In this category, that's unheard of. It's one of the ways a small company like us has been able to compete in a very large, heavily genericized category. We have all kinds of back-end analytics, all kinds of ways to have great visibility into every prescription such that we know how much the pharmacy is making. By the way, we guarantee that the pharmacy never loses money anytime they transact one of our brands. No other company does that. It engenders a great deal of loyalty from the physician because he or she is not getting the callbacks from the pharmacy saying that they do not have it or the copay is too high or it is on back order.
By the way, we've never had a back order in these products' history. The pharmacies love it because they have guaranteed economics. They have economics that they know will never be underwater. They're variable such that their economics improve when the patient's economics improve vis-à-vis a lower copay. That's all set up by design. We often can step around the big three wholesalers, which tend to extract a fair amount of value from the value chain by taking fairly high fees from branded manufacturers. 85%+ of our prescriptions of our ADHD brands are dispensed from pharmacies that order from us directly. That means the lion's share of those prescriptions that flow through our network are protected because the economics are protected across the supply chain, across the value chain, so to speak, such that the pharmacists are incentivized.
They want to fill a brand. They want to fill these brands because they know, again, their economics are fixed. These brands are reliable. This manufacturer backstops it for the patients to ensure they're not getting overburdened with the copay they can't afford. This is what I was referring to earlier. 85%+ of our core brands, and really most notably our ADHD brands, are dispensed through a partner pharmacy, which again means this is not a pharmacy like a Walgreens where they don't know Aytu BioPharma from Adam. They would just as soon not do business with us. When we're dealing with the local pharmacy, whether it's a regional, a small pharmacy, as we have several here in Las Vegas, we have several in Phoenix, we have several all over the West Coast where, frankly, we don't even have reps.
They love working with us because, again, they know the economics are there. They know that they're going to be taken care of from that perspective. They know they've got a company that's standing behind it to ensure that these patients are getting the most affordable copay. Actually, while it might sound like our economics would be worse orchestrating a program this way and essentially underwriting the prescriptions and discounting it, it's actually just the opposite. While the patients do end up getting lower out-of-pocket costs, we actually see an increase in refills. Actually, our gross to nets in many cases are higher when they run through the network versus when I say gross to nets, that's the net selling price after all the deductions from the list price. Refills are increased. Patients' out-of-pockets actually go lower. Pharmacies actually benefit.
They actually make a higher margin. Of course, we end up making a higher margin. Everybody wins. Most importantly, the patient gets the branded prescription they were prescribed as opposed to something that was prescribed and then switched at the pharmacy level, which happens all day, every single day across the U.S. We've got a 40+ person sales force that hovers between 40 and 45 reps in most of the major markets. We're not in every state, as you can see. There's still room to grow up into the upper Midwest, up into the Northwest, Rocky Mountains, even further up into portions of the Northeast. These reps are out there every single day interfacing with psychiatrists, pediatricians, primary care physicians.
Any prescriber who sees a lot of ADHD patients, we're in those offices and we're selling them on equal parts the benefits of our drugs along with the benefits of this really unique patient support program called A2Rx Connect. I can't emphasize enough, no one does the program like we do it. No one truly backstops their prescription and essentially steps in to take the responsibility on their own shoulders. In the event that those prescriptions aren't covered, we will eat that. We will take that loss for the benefit of that patient getting on therapy and that physician continuing to prescribe our brands over and over and over again. That's the name of the game for us. Find loyal prescribers that like the products, like the program, like the company, and they'll continue to write these products preferentially anytime they have an ADHD patient.
As I mentioned, we've begun to expand outside the U.S. We've just signed on over the last year and a half a couple of partners, one that has responsibility for Israel and the Palestinian Authority called Madomi Pharma. They're working through the Israeli Ministry of Health to get the product registered. No material sales there yet, but we would expect in the near term to start to see some movement there. Lupin Pharmaceuticals Canada, frankly, we're really excited about this. The Canadian market for ADHD is significant, well over CAD 1 billion. That's substantial. Lupin's fairly substantial as a branded manufacturer in Canada. They have the exclusive license to take both of our products, Adzenys and Cotempla, into the Canadian marketplace. Relatively early stages there, just working through the early stages of the regulatory process.
This isn't necessarily near term, but I'd say in the next 24 months or so, both of these should start to pay some dividends and bear a little bit of fruit. Excited about those opportunities. Really, for us, we've got a diversified approach here. We've got obviously a very strong presence in the U.S., and we're driving growth with our core brands, again, primarily the ADHD brands. We are starting to see some pickup from the pediatric brands as well, Karbinal and the multivitamins. We've just launched our first, what I'll call non-A2 product called Metadate CD. We've licensed this brand from a generic manufacturer and have just started to get this out into the marketplace, have put it into our A2Rx Connect network, and it's starting to show some early signs of growth, which we're excited about.
Very little rep support for that product, by the way. That's largely an A2Rx Connect play where we're putting it into the channel. We're optimizing the economics, and we're ensuring that patients are getting a trusted brand into their hands at a price that they can afford. With that, we've got a real asset. We've got a commercial infrastructure in the U.S. that has access to a big network of pharmacies, has access to thousands and thousands of prescribers, mostly in the psychiatry space. Again, we call in psychiatrists, but we also call on really anyone that sees a high volume of ADHD patients. With that, we're looking for bolt-on acquisitions that we can acquire relatively inexpensively. Medikate CD, for example, we acquired for $0 upfront.
We got it as just a license where we pay a royalty on sales, and we pay a transfer price to the manufacturer. Those are the types of deals that we think we can pull in here in the relative near to midterm as we grow. Obviously, as we get to higher levels of cash flow, true cash flow, we'll be able to not just reinvest that into the current business to grow our existing portfolio, but obviously, we expect to be able to acquire additional bolt-on assets that complement both of our A2Rx Connect network and our capabilities there, as well as our footprint and our therapeutic call points, which is largely in the psychiatric space. To find other assets in that psych space, we think could be important. For us, revenue has really been sort of solid in that it's been growing.
Some stabilization, you can see obviously a little bit of a downtick. That's almost entirely attributable to the pediatrics business. We do expect that business to come back to some degree. Even with modest growth on the ADHD side, if we can just get the pediatric products to a third or halfway to where they had been at their peak, this is a business that's +$75 million . What I'll say, people have asked us kind of what's our break-even point. $16 million a quarter is kind of break-even. We're almost there. We're basically right at a break-even level. If you look at our OpEx going forward, true OpEx from a cash perspective annualized is something like $40 million. That's not including D&A, so you need to add a little bit there.
Realistically speaking, with our margins of, call it low 70% range at just a little bit north of $60 million annualized, that's a business that's beginning to cash flow. We're right there knocking at the door of that. As I mentioned, OpEx has come down materially from where it had been. We cut out a lot of pieces of the business that was burning cash, cut out manufacturing, cut out R&D, sold off the consumer business such that now all-in trailing 12-month OpEx is about $42 million. That number does include D&A. It's actually even a little bit lower than that when you talk about true cash uses. Again, call it a $40 million spend rate on a trailing 12 basis. Again, if you say low 70% margins, we're essentially profitable at that level. +$20 million in cash at the end of December.
When you look at shares, real shares in terms of common shares is a little bit less than this, but we have some pre-funded warrants that takes really basically our, I would call it actualized or common share equivalents to something like 8.2 million outstanding. We do have some warrants, many of which are out of the money that takes us fully diluted to about 12.3 million. Other than that, pretty straightforward. We do not have any preferreds. We do not have any real significant bells and whistles, pretty regular way warrants. Again, most of those are out of the money. Long story short, a lot has happened over the last few years to align us to get ourselves to profitability. We have grown organically. We have had some benefits of market factors, but we are back to really realizing growth from an organic perspective.
Pediatric portfolio is back to demonstrating growth, strong cash position. We're really not burning very much cash at all. Ultimately, we're looking for additional assets to bolt on to the portfolio that fit within the A2Rx Connect platform as well as within our capabilities as an organization that calls on psychiatrists and ADHD specialists. We're always looking for new assets, two licensing deals with Lupin and Madomi outside the U.S. to further bolster and diversify our revenue streams. Again, we're focused on the Rx business, having really shut down all those things that essentially were burning cash, and we think probably we're not going to add value in the immediate term. Sorry, I ran a little bit late there, but if there's any questions, we can take those.
Yeah, just talk a little bit about what type of an acquisition might make sense for you, given the infrastructure that you've built, the A2Rx Connect platform.
Yeah, the sweet spot, the real bullseye, I think for us would be a psychiatric asset that is near to market or on market, something that we can walk into a psychiatrist's office and have sort of a multi-part detail. I'm an old drug rep, having called on physicians for the first few years of my career. You typically have time for two or three conversations. To be able to sell the ADHD meds and then to be able to talk about another asset, something like an antidepressant, an antipsychotic, something for bipolar disorder, or another ADHD med, things like that would really be in the sweet spot.
We could also look at non-psych-related assets if they fit within the RxConnect sort of algorithm. Branded medications that potentially compete in generic categories where pharmacists really want to dispense the brand. We could go one of two ways. It gives us a relatively open mandate, but those are the two ways we would look at.
Maybe talk a little bit about the macro trends both on the ADHD side as well as the fluoride. You mentioned some of the political factors at play, especially surrounding fluoride.
Yeah, many of you have heard that RFK in particular is not a big fan of fluoridation. There has been a big movement afoot for many years, but this happened way before RFK even became a thought of being Secretary of HHS. There has been movement for years around getting fluoride out of the municipal water supplies.
If that happens, and by the way, as I mentioned, Utah just banned fluoride in the water supply. If that happens, it only stands to benefit us and our fluoride franchise. That actually could be a benefit. Some people have asked about how are your ADHD meds affected by virtue of any potential threat of tariffs. What I'll say is de minimis. There'd be a de minimis effect. All of our products, by the way, are manufactured in the U.S. Very little input from Chinese API suppliers, very little supply at all from overseas. All of our APIs for ADHD meds are 100% manufactured here. Minimal impact from any tariffs from that perspective.
Any additional questions? Great. Thank you very much, Josh.
Thanks for the time.