I would now like to hand the conference over to Mr. Tom Duthy, Investor Relations. Please go ahead.
Thank you, Harmony, and thank you everyone for joining today's call with Mayne Pharma and DistributeRx executives. It's certainly an exciting period for Mayne Pharma with the launch of DistributeRx this week, as announced on ASX yesterday, 10th of March, 2026. If I could have the next slide, please. This is our important disclaimer. We will be making forward-looking statements on today's call. Investors are encouraged to read this disclaimer before making any form of investment decision. Next slide, please. The agenda today is quite straightforward. We have six modules. I will shortly be introducing our esteemed speakers today, who will then provide some background on Mayne Pharma, who for those investors who are less familiar with our story and our journey thus far into our DistributeRx launch this week.
We will then provide a U.S. healthcare primer and what is the market need for business like DistributeRx as part of overall Mayne Pharma's journey through this disintermediation process that we've been undertaking for a number of years now, and that will be captured in module four today. Finally, we will present the DistributeRx business model and the opportunity for DistributeRx moving forward as part of Mayne Pharma. We'll finish today with some investor Q&A. I might add that we have received a significant number of questions ahead of today's call. We thank investors for them. If we do not get through those questions in their entirety, noting the one-hour duration of today's call, we will certainly make every effort to respond to those questions after the presentation today. Next slide, please.
It's my pleasure to introduce our three speakers today. We have Mr. Aaron Gray, who's the Chief Executive Officer of Mayne Pharma. Our investors will be very familiar with Aaron, having recently been the Chief Financial Officer of Mayne Pharma. We have Daniel Moore from DistributeRx. He is the President of DistributeRx. We have Meredith Gambill, who's Vice President of Sales and Marketing at DistributeRx. Both persons will be familiar with Mayne investors from an investor education webinar we undertook in 2025, and we're delighted that they are able to join us today to talk about DistributeRx. With that, I would now like to hand the call over to Aaron Gray. Please go ahead, Aaron.
Thank you, Tom, and thanks everybody for joining. This is a journey that's been underway for a long time. Mayne Pharma has been talking about disintermediation since before I joined the company, for at least five years. This launch really is something different. This launch is the full launch of a wholly owned company, a Mayne Pharma wholly owned company, which is DistributeRx, which really brings the advantage to Mayne and to others based upon all of the work that's been done by the Mayne Pharma team, understanding what moves drugs through the channel and what are the relative issues that various methods of getting products to patients creates. Next slide, please.
By way of background, some folks may not be familiar with Mayne Pharma, so I've got a few slides here just to talk who we are quickly before I turn it over to the DistributeRx leadership team. Next slide, please. Mayne Pharma. Mayne Pharma is an ASX-listed specialty pharmaceutical company. We are comprised of three business units: our women's health unit, our dermatology unit, and our international unit. Those three business units have basically come to be after a path of transformation that the company's been on over a significant amount of time. Company currently trades at approximately 0.5x trailing twelve-month sales, something that we're working to change. We are continuing to try and drive investor and shareholder value in the company. Next slide, please.
This slide shows a snapshot of our various segments. This is the proportion that each segment contributes to our total revenue from our fiscal year 2025 result, and then our segment contribution. Segment contribution is given by gross margin minus direct OpEx, so it's a reasonable proxy for EBITDA of each individual segment. As you can see, the single largest segment that we have is women's health. Women's health is comprised of four branded women's health products. This is now the single largest contributing segment to our company with respect to contribution, in large part because of the growth of those assets and because of the margin profile of those products. Fiscal year 2025 was a pretty good year for Mayne Pharma.
We returned in spite of significant distraction based on some legal wrangling that we had, which I'm sure most folks are familiar with. We returned a 76% increase compared to the PCP on the direct contribution of these businesses. We are a growth company. We are focused on growth, and we are focused on profitable growth. Next slide, please. This is a view of how our physical locations break down. We have our manufacturing facility, our CDMO in Salisbury, Australia, which is also the head of commercial efforts. We have salespeople distributed throughout Australia focused on commercializing our products as well as products we manufacture, as well as products that we in-license. In the United States, we have our global headquarters in Raleigh, North Carolina, where the Mayne Pharma and the DistributeRx logo are.
Likewise, we have our sales team distributed out throughout the United States in geographically to where the customers are located. We have our Adelaide Apothecary, our wholly owned pharmacy that's licensed in all 50 states, located in Lexington, Kentucky. Next slide, please. This is a breakdown of the revenues. That first line, United States, obviously is the largest number, the single largest contributor to our revenue, and it's been the highest growth driver. This is really comprised of the dermatology business unit and the women's health business unit. The rest of the revenues that we derive, Australia, New Zealand, AUD 42 million, Canada, AUD 20 million, Europe and Asia, respectively, those are through out-licensed agreements, and those are all run through our international business. We have a total of AUD 408.1 million in sales.
This was fiscal 2025, with 467 employees, roughly split evenly between the United States and Australia. Next slide, please. Mayne Pharma in 2026. Mayne Pharma has been on a journey to transform from a retail generics-focused company to a differentiated branded company. This slide highlights the volumes that we realize coming from branded products versus generic products and how the gross margin has developed across the years. That gross margin has developed because of the increase in the overall mix of branded relative to generic products. It is also developed because of some of the things that the Mayne Pharma team has created with respect to the channel. Really very proud of the team, great accomplishment, and we have more work to do. We have more room to grow, and we have more work to do.
Next slide, please. Disintermediation. We've talked a lot about disintermediation. It's not the easiest word to say in the world. But basically what it is, there's a thing in pharma, in U.S. pharma, only U.S. pharma to the best of my knowledge, called gross to net. Gross to net is the difference between what you sell your product for and what you ultimately recognize as revenue. Much of the difference between those two is intermediaries or different people that you have to pay for different reasons. This could include wholesalers, this could include payers, it could include PBMs. It includes dispensing out of pharmacies, it includes patient support and copay. This is a significant topic for all U.S. pharma companies to manage. Gross to net is the single largest topic that most companies have to manage.
Unless it's a very well-covered product or a rare orphan disease type product, gross to net is greater than 50% of most companies' revenues. For Mayne Pharma in fiscal year 2025, our gross revenues were approaching AUD 1.4 billion, and our net revenues, as you saw, were just north of AUD 400 million. Managing that AUD 1 billion between is really what Mayne Pharma has had to work to become good at and to really understand all of the different levers, all of the different dynamics, and really figure out how to survive and how to thrive in the environment. Disintermediation started as, I would say, an enabler for the company to be able to survive and now has actually become a business model, hence the launch that you all are attending here today. Next slide, please. Disintermediation.
What are some of the benefits? From a manufacturer perspective, there's a benefit for inventory. Through our disintermediation, we've partnered with specialty pharmacies and of course, as I mentioned, we own our own pharmacy licensed in all 50 states. That gives us higher control over inventory. That means that we are closer to the script volumes. We are closer to the person that is actually dispensing the medicine to the patient. That gives us the ability to understand when inventory levels are developing in a direction that may not be productive. Those partners, the specialty pharmacies and our own pharmacy, of course, have different rates of return. If we manage the inventory, we have different risk of return.
Product returns are extremely expensive because you have to basically pay back to one of the wholesalers the entire value, in many cases more than the value, that you actually were paid for the product to begin with. Another benefit, it gives us a stronger negotiating position with the spec pharmacy versus the wholesaler. You've got a pharmacy whose focus is serving patients and providing patients access to products. That's the same focus that we have. We have common goals. We understand each other, and we come up with, I think, a relatively balanced way of arranging transactions with our pharmacy partners. Less intermediaries drives lower fees in totality. Having fewer folks with their hand out along the access chain really drives differentiated outcomes for Mayne Pharma.
This allows us to realize profitability on cash scripts where many businesses cannot make money on cash scripts. It allows us to realize better outcomes than perhaps some of the alternatives. Beyond Mayne Pharma, there's also some direct benefit to patients. Daniel can talk a bit more about some of the challenges that patients face with their medications, but one of which is one of the big challenges that I hope many of you have not experienced, is transparent and predictable costs. In many cases, when your doctor writes a prescription, neither you nor the doctor have any idea what that is going to cost.
Even if you are an insurance expert or work for the insurance company, it's unlikely that you will know what that is going to cost because there are so many different factors that come together to determine what you're going to pay for that medication. In some cases, you might actually end up paying, even though you have insurance coverage, more than the actual cost of the medication. Another patient benefit, greater certainty on copay arrangements. There's not a lot of fluidity in terms of if you get it on formulary from this, under this plan, it's reimbursed at X. If you get it somewhere else, it's Y.
It's a very uncertain system today left to its own devices. There are some products you simply can't get access to, and there are some products that based upon the different options, which you don't have transparency to. Keep in mind, you have no idea which one is the best for you, both in terms of being able to get the product and in terms of being able to understand transparently what you're going to pay for the product. There's a direct benefit with rates of fulfillment. So many patients abandon scripts. That means your doctor writes a script, and the script never gets filled. There's a lot of reasons for that. Sometimes patients can't actually get the medicine. It's not available, even though it should be made available. There are substitutions.
Patients have tried medications, and there's an attempt to substitute different medications that maybe don't work for that patient, so they walk away from it. In many cases, there's uncertainty or cost barriers that prevent people from being able to take their medications. Finally, it's simpler for repeats. That's good for the patient and good for the manufacturer because obviously higher repeats translates to higher volume. It's a more efficient approach for the patient. It is a leaner approach when they go to get their medication, and out of this, everybody wins. Next slide, please. I think here I turn it over to Mr. Moore. Daniel.
Thank you, Aaron. Appreciate it. Thank you all for joining. I'm gonna take you through, let's title a U.S. healthcare primer, which is really an explanation of some of the intermediaries that Aaron discussed before. By way of background, Daniel Moore, I've been with the parent company, Mayne Pharma, for almost 11 years now. I've been here from the beginning of the journey on disintermediation and super excited about this launch of DistributeRx. Next slide, please. Some key terms, pharmacy benefit manager, PBMs. These, what have become very large entities, specifically these three that are examples here, they control over 80% of drugs dispensed in the U.S., in terms of covered lives. They're setting drug coverage and negotiating prices.
They're not just negotiating with downstream pharmacies, they're also negotiating obviously with manufacturers for rebates and discounts. You know, these guys are for-profit entities, so any discount that we provide obviously doesn't all translate to the patient. It's one key inefficiency that we talk about here specifically with DistributeRx. Pharmacy service administration organization or PSAO. They represent pharmacies to negotiate and administrate contracts with payers. This includes, you know, reimbursement, network participation. The three entities you see to the right, McKesson, Cardinal Health, and Cencora. Cencora was formerly AmerisourceBergen. These are the three large wholesalers. They are wrapping up a bunch of services for independent pharmacy and providing those to retailers.
Again, for-profit entities all in the Fortune 10, I believe, of U.S. companies. Massive organizations that the service they provide is not free of charge, and therefore, it impacts the patient downstream. Group purchasing organization or GPO. These exist in all sorts of industries. In pharmaceuticals, you can see Premier, Inc., HCA Healthcare, and Vizient, Inc. are large players. This really impacts hospital sales and institutional drug purchases, but they're aggregating buying power to negotiate lower prices. Again, this tends to impact manufacturers in terms of lower pricing. Once again, you know, a for-profit organization that's passing savings on to their members that doesn't necessarily translate into the patient's out-of-pocket cost. A formulary. This is really set by the PBM.
This is what determines whether a drug's covered or not, what the patient pays in terms of a copay. You know, oftentimes tiered. You know, used to be pretty simple two-tiered system here in the U.S.. Now we're five and six tiers across copays. Some of these are denominated in whole dollars, you know, 15, 25, 30 dollar copay. Others are a percentage of the list price of the drug, that a patient's responsible for, before their insurance kicks in. What we've seen in the U.S. market is a very large prevalence, specifically over the last seven or eight years, of patients being pushed into high-deductible plans, principally by their employer, because it's more cost-effective for the employer. This means that patients are responsible for a large amount of their drug cost up front.
If you don't have serious underlying conditions, oftentimes you'll never meet that deductible, even though you could spend $2, $3, up to $5,000 per year. It's really pushing the burden on patients, even though they have insurance. The high-deductible plan's really catastrophic coverage in case you have a serious medical condition that arises during a plan year. Probably the most important one you'll find most prevalent in Google, especially lately, is direct to patient. Tons of pharma companies are trying to figure this out, trying to provide cash pricing. I'm sure you've seen TrumpRx in their attempt to provide transparent cash pricing to patients. The three entities are obviously large pharma companies that are participating in this today.
I think it's a great initiative, but some of the plans that have been developed are limited in terms of the true price benefit you can provide the patient. A lot of these direct-to-patient plans run on the same rails as insurance coverage, which means there's still intermediaries between that manufacturer and the patient, even though it's categorized as direct to patient, which is why you'll see some pricing still, you know, north of $150 per month for a chronic med. It's still a direct price, but it's not necessarily affordable for most patients. What we'll get into with DistributeRx is how we're managing that and how we're really taking the next step in direct to patient through our wholly owned channel. Next slide, please.
This is a visual of all the entities I just talked about. You can see all the various points between the manufacturer and the patient. All these points in the middle, the key part here is they're all profit takers, ultimately. These are not-for-profit entities. It's not a government entity that's just single payer and ultimately self-funded. What happens there is if you start with a $100 drug. The manufacturer has a 70% gross to net, so they command $30. Well, by the time it gets to the patient, the patient may be paying $75 or $80, 'cause the bulk of that, the discount didn't make its way there.
Mayne Pharma and the patient would be far better off if we could just sell the product directly for $50, which is in essence what we've created here, with an opportunity to still access the most profitable prescriptions that run through this spiderweb of a system. Next slide, please. As stated, our model's efficient and profitable. We've spent a lot of time trying to figure out how to make this work. Ultimately, we're removing as many intermediaries as possible, while providing insurance coverage as an option for patients on the front end. Our process is simple. If a drug's not covered, we don't ship it through a wholesaler. It never gets in front of a PBM.
It goes directly to our pharmacy, and a patient transacts directly with the manufacturer for cash. It's efficient. We review prescriptions through our channel, oftentimes inside of 30 seconds from receipt, so patients have clear understanding of what they're gonna pay. The providers that we call on understand exactly what patients are gonna be expected to pay in a worst-case scenario, so they can have transparent cost conversations at the point of care. As I noted, it's direct, meaning there's not three people between us and the patient. The product goes directly to our pharmacy and shipped directly to patient. It creates less delays, greater adherence, incredibly high customer satisfaction. Next slide, please. Our solution, apologies, we wanted to make this simple, but I also wanted it to be clear in terms of what actually happens.
In this model, you can see DistributeRx working alongside manufacturers. Mayne Pharma obviously would be a manufacturer client of DistributeRx. We're helping to inform clinicians through our sales team that Meredith manages of the offer that we have on a wide variety of products. Obviously, that would be Mayne Pharma products, but we carry as of today, over 200 dermatology products. Patients have a tremendous portfolio to access for any of their mild to moderate or in some cases, severe diseases. We will continue to provide that service to Mayne Pharma and other manufacturers. What happens after we talk to clinicians. They have a clear understanding of what patients may pay with insurance or without.
Every patient is eligible to utilize our service. That prescription is e-prescribed to CoAssist, which is our front-end pharmacy that does all the electronic benefits verification and adjudication. A patient's insurance is checked to see if they have coverage. If they do have coverage, that prescription is transferred to a contracted pharmacy and dispensed to a patient at a very low cost, oftentimes $0 out-of-pocket. If the patient doesn't have coverage for that drug, the prescription is transferred directly to Adelaide Apothecary, where we transact with that patient for cash. No insurance is required, and they oftentimes get that product in 2-3 days after the initial prescription is written.
As we stated earlier, Adelaide Apothecary is a wholly owned subsidiary of Mayne Pharma, so we interact directly with them, from Mayne Pharma and consign inventory there, for dispensing direct to patients. That transaction is 100% between the manufacturer and the patient. That's a key distinction of our model versus some others, as that transaction is not governed by any oversight from the federal government in the United States. The OIG has put out recent guidance that clarifies this fact. What that means is this price that we provide to patients does not impact best price. It does not impact other rebates, specifically government rebates.
Therefore, we can have a very aggressive price that meets patients where they are and allows us to remain profitable, even at relatively low costs in terms of an out-of-pocket expense. Next slide, please. This is just an overview of our corporate structure. Just to reiterate, Adelaide Apothecary, DistributeRx, and our commercial arm in the U.S., Mayne Pharma Commercial LLC, are all 100% subsidiaries of the Mayne Pharma Group. Next slide. How big is this opportunity? Which I'm sure is a question, and I know it's a question on many of your minds. While Aaron will remind me that we do not provide guidance, we can talk some about the market and how things are shifting, to paint a picture of what this opportunity looks like for Mayne. Next slide, please.
As I went through, the problem here is obviously deep consolidation and vertical integration across PBMs and pharmacies that's created a very complex model that's not great for manufacturers, including Mayne Pharma, but also not predictable for patients. Our goal is to reduce the friction between Mayne Pharma and the intermediaries, but also for patients and providers, so that they have clarity around what drugs are gonna cost, and they can have that conversation at the point of care. Ultimately, this reduces profit leakage from the time the product leaves the manufacturer before it hits the patient. In terms of the market size, it's estimated that the cash pay market is gonna grow to $252 billion by 2030.
In 2024, patients paid through copay and out-of-pocket costs for drugs over $800 billion in the United States. It's a fairly significant shift to cash pay, that's already well underway. There's a tremendous amount of consumer adoption of digital pharmacy and home delivery. This has historically been a very small portion of the market in the United States, that has accelerated, largely likely due to the COVID-19 pandemic from 2020, but continues to grow, even now. It's important to note our investment into DistributeRx to date is roughly half a million dollars in U.S.. We are utilizing staff, headcount, knowledge, infrastructure, from the legacy dermatology business, formerly, you know, identified as PPD in our financial statements. Next slide, please.
Just a visual of the problems in the system. Aaron spoke a lot about unfilled prescriptions. We see this as the number one opportunity here is patients had intent, they had prescribers that wanted them to get a product and this number is. It's very difficult to understand exactly what it is in the U.S. market. It's at least 30% of prescriptions, if not, you know, significantly higher. Clearly an opportunity not just for Mayne Pharma, but for patients to seek and receive better therapy or better treatment than the current system allows. Obviously, there's a tremendous profit uplift for manufacturers to remove the intermediaries between themselves and patients. Pharmacies are also losing money on transactions today, where reimbursement has been cut, and they can't fill prescriptions.
We have a solve for that inside of the DistributeRx infrastructure for our contracted pharmacies as well. There's a tremendous amount of formulary exclusions. What formulary exclusions means are branded or even generic drugs that are blocked from a plan, meaning you have no way to get coverage if you're a patient that carries that type of insurance through a certain PBM. This number was less than 100 drugs in 2016 and is in 2025 estimated to be almost 800 drugs across the top three PBMs on every formulary. A massive amount of patients that can't access the therapies that their providers want them to have. This is leading to an expanded cash market. Patients are more comfortable paying cash. They seek savings opportunities.
GoodRx is a massive discount program here in the U.S.. They have tremendous utilization because patients are very accustomed to their insurance potentially not being the best price for the drug they wanna acquire. Next slide, please. Key takeaways for Mayne from our journey on disintermediation so far. From a revenue perspective, we have an 83% CAGR since FY 2023 on cash-paying prescriptions. This continued growth we expect to accelerate as a result of the launch of DistributeRx and a sales team focused on specifically this effort. 59% of our volume as a group in first half fiscal year 2026 went through the non-wholesale channel, meaning outside of the traditional model that most pharma companies utilize.
This is a capital-light opportunity, which leads to it being highly scalable. We're very confident that we have the infrastructure to execute near term, and any infrastructure needs over the long term are gonna drive minimal cost expansion for the business. Next slide, please. Just a little timeline of our journey. Adelaide Apothecary was founded in 2021, so almost five years ago, or a little over five years ago, actually. We had our first prescription flow through there. We acquired the women's health portfolio from TherapeuticsMD. We included that on this slide because TherapeuticsMD had a very unique go-to-market strategy with vitaCare prescription services.
We obviously utilized that in the early days, and we were obviously well on our way, but also saw some of the things that maybe we would wanna do to improve our infrastructure. It actually gave us pause on a few things that we needed to iron out from a legal and regulatory perspective. It was a great opportunity for us to learn what others had maybe done before us. Then we launched a pilot in 2024 with GoodRx as a partner on that pilot. They had purchased the vitaCare business prior to our acquisition of the TherapeuticsMD products.
That has led us to this moment in 2026, where we have a tremendous amount of growth that has already occurred inside of this business. Really excited about not just our platform, but the macro trends of where the market's going because we think we have a solution that's fit for purpose. Next slide, please. Getting into the details of DistributeRx. Next slide. At its core, this is about prescription access made simple. We partner with manufacturers, providers, and pharmacies to improve patient access and offer predictable pricing. Predictability is huge, not just in our market research, but also in our customer data. People like knowing what they're gonna pay. They don't like being surprised. We don't always have the best price, but people love the fact that it's predictable.
There are no strings attached. What we say is what we do. It's been a very strong signal that we're moving in the right direction. Next slide, please. The operational arms of DistributeRx, I'm gonna cover the first two, manufacturer services and pharmacy services, and then I'll hand it over to my colleague, Meredith Gambill, to cover the customer-facing services. Moving to the next slide, diving into manufacturer services. This is a huge opportunity for us. The team that's responsible for manufacturer services is the same team that worked inside of the Mayne Pharma Group to do all of these tasks on behalf of Mayne Pharma. We've created additional bandwidth through this team with improved data and analytics and tools so that now they can serve other manufacturers as well.
It's really a big key to how scalable this business is, that we'll be able to provide these services at the same level we had historically to Mayne, but also contract with other manufacturers to utilize the services of DistributeRx. This is pharmacy network establishment, refill programs, patient adherence solutions. There's pharmacy monitoring solutions to understand how various pharmacies are reporting or performing across the country. And then obviously access to our full-service cash pharmacy at Adelaide Apothecary, which we can discuss on the next slide. Adelaide Apothecary, the main advantage is patients have timely access to the exact treatment their providers prescribed with a predictable price. There's no PA prior approval requests that have to be completed with their PBMs. They know exactly what they're gonna pay when they show up at the pharmacy.
They get live consulting with one of our pharmacists or technicians about the drugs they've been prescribed. We can serve patients in all 50 states and Washington, D.C., which is a very rare phenomenon in the U.S.. Pharmacy licensing is determined on a state-by-state basis, so it's a very complex process, but it sets us apart from others in this space. The real opportunity here is what's happening in the cash pay market. It's doubled in the last three years, and even insured patients frequently pay cash when their plan doesn't cover medication. 61% of insured individuals paid out-of-pocket for a prescription in 2022, and that's obviously continuing to grow. Only 25% of Mayne Pharma's dermatology prescriptions were covered in September 2025.
That means 75% of this business is effectively cash pay from a Mayne Pharma derm perspective. We don't see the macro trends changing. We see more prescriptions potentially being uncovered, and therefore patients will be forced to pay cash. We have an opportunity and an offering that meets them right where they are and allows them to have a transparent option that's predictable for their drug spend. With that, we can go to the next slide. I'll hand it over to Meredith Gambill, our VP of Sales and Marketing.
Okay. Thank you, Daniel. For a bit of context-
That's cut out, Daniel. You might need to cover on that one.
Sure. No problem. I'm sure Meredith will be right back. She'll be furious with her internet provider. The customer-facing service of DistributeRx is really about where our sales team comes in. The customer here, we're talking about clinicians, so doctors in the United States. What we're really trying to do is show them that there is a way for their patients to understand pricing at the point of care. They can get certainty around the product they're gonna receive, and that product will be delivered, whether covered or uncovered, at the convenience of their own home. Meredith, I see you're back, so I'll turn it back over to you.
All right. Great. Thank you, Daniel. For a bit of context, I've worked in dermatology since around 2009 and have spent much of that time working very closely with dermatology practices. What that experience has shown me is that many of the access challenges that Daniel went through, that Aaron talked through, they describe and what they describe are most felt by the patient and.... [inaudible]
Daniel, you might have to cover, I think. It's pretty intermittent, Meredith at the moment for us.
Sure. No problem. Meredith, I'll just let you investigate and come back when you're ready. The beauty of this service, you know, talked about product certainty, but it also prescriptions are reviewed automatically. It's reviewed very quickly, as said earlier, often inside of 30 seconds. A patient will submit a prescription into our channel. They get a coverage outcome almost, like I said, instantaneously, and they know exactly what's gonna happen at the pharmacy. They receive communication almost immediately as well, so they're really a white glove service in terms of patient facing here from our pharmacy and pharmacy partners. Next slide, please. So why dermatology?
Obviously, Mayne has a long history in this space, but we also notice that there's incredibly high patient demand. You have motivated patients that are seeking treatment, but those motivations are often met with significant access challenges due to the pricing practices that we noted earlier. Insurance coverage continues to decline, but prescribers wanna prescribe branded products. Oftentimes, they're writing a branded product. They're choosing where they have to send it, hoping that it's covered. What we're able to provide is, again, clear, consistent access with a predictable outcome, for that patient. From a timeline perspective, we launched our pilot in October 2023.
This was in high-need dermatology practices, places that didn't have options from a pharmacy standpoint that were really working in the best interest of the clinician and the patient. We saw very strong results in the three months leading into January 2024. When we rolled this out nationally to our entire field team as an option, one of many options of pharmacies that they could utilize that held our products. In 2025, we engaged with a large group of clinicians to get feedback on how the channel was working for them. We identified several areas of improvement and also identified that these clinicians saw clear value and they love the transparency and the speed with which patients could get the products they need. Next slide, please.
Meredith, do you wanna try again? Oh, she's on mute. What we're seeing
Can you?
Yeah, give it a shot.
Okay. I am so sorry. I have full service, and I have no idea. This is a slide I am very proud of, and we'll see. If it cuts out, then we'll just cut me out. I would say with any new healthcare solution, the most important question is simple: Do physicians actually use it? In dermatology, the answer is yes. What we've seen in dermatology is strong adoption and sustained engagement. You can see there on the screen, since launch, we've seen meaningful traction, so over 39,000 prescriptions fulfilled, 37,000 patients served, and more than 3,800 active prescribers in dermatology. Beyond the data, clinician feedback has been very consistent, as reflected in the quote shown here.
Physicians value the simplicity of the workflow, transparent pricing, and the ability to prescribe confidently knowing their patients can access the medication. All in all, these signals show this isn't just early adoption, it is sustained physician engagement. Next slide, please. All right. Lastly, you know, it's helpful to consider how our solution compares to other options in the U.S. market. There are several well-known pharmacy models today, so you can see, you know, including national specialty hubs, Amazon Pharmacy, and Mark Cuban's Cost Plus Drugs. Each offers certain capabilities. None bring together all the elements required to fully solve prescription access challenges. Some services offer fulfillment, but limited prior authorization support. Others focus primarily on pricing, but lack integration with physician workflows. Independent pharmacies may offer expertise in specific therapeutic areas, but often, you know, they lack national scale.
The question is: What differentiates DistributeRx is that it integrates these capabilities within a single solution. We bring together prescription fulfillment, home delivery, prior authorization support, transparent pricing, dermatology expertise, insurance independence, and national scalability all within a single integrated solution. Daniel mentioned earlier, you know, importantly, we also operate our own cash pharmacy through Adelaide Apothecary, which allows us to maintain consistent pricing and greater control over the patient experience. Rather than just solving one piece of the problem, DistributeRx is designed to address the entire prescription access workflow. What you've seen here and what you've been able to hear from me in the last couple of slides, thankfully, is really, you know, this is the early deployment in DistributeRx and dermatology, especially where access challenges are significant and where we're already seeing strong traction.
As we continue to scale this solution, the opportunity is to extend this model across additional therapeutic areas. All right. With that, I'll hand it back to you, Tom, for Q&A. Thank you.
Thank you. Thanks, Meredith. If you could, next slide. Thank you. That's good. I'll start with some questions that were asked in advance of the webinar today, and then I will turn over to Harmony for some dial-in Q&A that I see has popped up. The first question I think nicely dovetails, Meredith, into the message you just provided, which is: Can you comment on the barriers to entry for new or existing competitors that DistributeRx's disintermediation initiatives will provide?
Sure. I can take that one. One of the key things is obviously the pharmacy, Adelaide Apothecary. The journey to you know being able to provide this solution nationally was one that took several years. There's just no shortcuts to several of these states, and the laws are constantly changing. Our pharmacists there do a great job of staying abreast of what needs to be done. They have a ton of experience in the space, obviously, as well. I think you also have to have an, you know, experience in the therapeutic area where you start. Obviously, Mayne been in dermatology for some time. The time is really a big factor, just based on the pharmacy alone.
The other piece is, if you look at the larger side of pharma, right? The three logos that we showed earlier from a direct-to-patient perspective, they're looking to launch billion-dollar drugs. If they're not launching billion-dollar drugs and billion dollars in net sales of those drugs, their company's not too excited. This is the opportunities in the millions, especially early on. There's no shortcut to get to a billion dollars here. It's gonna take time. How interested those players are gonna be to start from the ground up and really lay, you know, take the time to do it, we'll see.
We do think this is a massive opportunity, especially given the trends in the market, but it all starts with one prescription, which is not that exciting for a lot of entities that are, you know, looking to build something like this if they wanna build it the right way.
Thank you. The second question relates to the scalable growth profile for DistributeRx over the next 6-12 months, and if there were some certain milestones, Daniel, that you would see as important, for financial investors in Mayne Pharma, particularly over the next 6-12 months. How should we sort of track the scale and the growth within DistributeRx?
Yeah, absolutely. I mean, patient pay dollars is one thing that I think is critical, right? Just the dollars of prescriptions. It'll fall in line with the number of scripts we grow through this channel. Obviously, another key metric that we wanna track is the number of adopters, and we've defined that as somebody that sends 20 prescriptions in any quarter. We need people believing in this solution at scale, not just dabbling with it. That's an important metric to follow. I think just looking at the macro trends of the U.S. market, right? Is something gonna come out and dramatically, you know, create PBM reform or some massive change-up? People have been talking about this for well over 20 years now, and we're still kinda stuck in this very fragmented system.
I'm not bullish on that happening, but that's something to monitor and I think with our government so focused on cash pricing right now, I think we're in an ideal position to take advantage of the macro trend.
I think that comment again fits nicely with the next question. If we were to cast our eye forward 2-5 years for DistributeRx, who in your view are the most logical strategic partners or potential acquirers in this market across the value chain that you've eloquently articulated earlier on, Daniel?
Sure. Look, I'm reluctant to mention companies by name, just because, you know, if I end up getting it right, you'll think that I'd already sold it before I said it. That's just simply not the reality. I do think larger manufacturers at scale will be very interested in this. If you think about the direct cash pricing today that you see, at least I see it in advertising here in the U.S. all the time, that's not their net price, that patients are paying. They're paying fees on top of that. Probably somewhere between 10%-25% even of the direct-to-patient drug pricing you're seeing, an intermediary is taking that away.
Somebody at the big end of town, large pharma, they may see this as a massive, you know, opportunity just to push their products into here, and recoup that 10%-25% that they're losing. Any retailer that's involved at scale nationally in pharmacy may be interested in this. It's a unique way to partner with manufacturers and really provide a solution to customers. I mean, pharmacy's always been a way to try to attract customers for grocers, or you see Amazon doing it, as well, so a big retailer. Potentially somebody that's another, you know, disruptor in the space. There's all sorts of healthcare disruption in the U.S.. This really provides, you know, a platform, if there's somebody there.
For right now, our primary and total focus is executing this with the best of our ability to you know accrue that return back to the Mayne Pharma Group. We have a roadmap that builds this out well beyond 2-5 years of how we wanna go to market. I'm excited to be here and share it and you know generate as much as we can for our current shareholders 'cause we think this is a tremendous opportunity for our parent company.
Great. We have a question before I turn to a phone dial-in briefly, which is sort of the bifurcation of branded versus generic. The question is what impact is expected for Mayne's current branded portfolio? I will just dovetail another part to that from a certain other question, if I may, and that is, you know, if we were to call out, you know, which of our branded products in women's health or dermatology are most sensitive to improved patient access and reduced product abandonment, such as returns or even a lack of prescription fill, are we able to sort of make, you know, any comments there on those sorts of dynamics with our branded portfolio under this model?
I can. I mean, I think the branded business in dermatology, the biggest impacts are gonna be those that are the biggest products for Mayne Pharma. You know, RHOFADE's been our flagship product since we acquired it in October 2023. That product still has the same abandonment issues and coverage issues that we talk about in the slide. So our performance there, year to date or life to date includes those issues. So if we can improve that, from DistributeRx, you know, as a service to Mayne Pharma, that obviously is gonna improve the earnings of Mayne Pharma. So in derm, you know, it's RHOFADE, DORYX, TWYNEO, and EPSOLAY, that would be the top four. And then in women's health, it's the same, although I do wanna make a point of distinction.
The DistributeRx team at launch, we're not calling on OBGYNs. We're not in those offices. There is a solution that is available to the Mayne Pharma Group for that, but we don't have reps in those offices just because it would be a little bit much for our reps to call on both. It is something we're assessing for future plans once we get further into the launch.
Okay. Thank you, Daniel. Just one final one, which again, I think dovetails nicely into what you've just mentioned, and that being, is the DistributeRx team new headcount or existing staff with new titles?
Yeah. This is all existing staff with new titles, so it's pretty much a lift and shift of our PPD organization, our dermatology-focused sales team, to focus on DistributeRx. Which is great because they have relationships with practices. As our general counsel said recently, we don't lobotomize people, so they're still gonna have these relationships. They can still walk in and be very familiar, and it gives us a head start with our launch. From a commercial side, we brought a few folks over from the commercial operations team to provide services back to Mayne from DistributeRx. It gives us great continuity. Obviously, we're all familiar with one another, and there was no real hiccup with our recent launch.
Thank you. Harmony, I might turn over to you for any phone-related questions. Thank you.
Thank you. We do have an audio question from Andrew Goodsall from MST Marquee. Andrew, please go ahead.
Oh, thanks very much. Just trying to understand, obviously the rollouts.
Yeah.
Well underway with derm. Just trying to understand how dependent DistributeRx is on adding pharmacies or clinicians using CoAssist, and how challenging it is to add those pharmacies or clinicians.
Yeah, yeah. I can answer it. I can take that question. From a pharmacy perspective, there's a network of north of 400 pharmacies that Mayne Pharma and ultimately DistributeRx is now consulting with Mayne Pharma on this, that's in their specialty pharmacy network. Those pharmacies operate across women's health and dermatology as well as other specialties. From a clinician standpoint, the responsibility rests on the sales rep.
You know, we have those relationships in place obviously from cutting this team over, from being product-focused in dermatology to now access-focused, through DistributeRx. I don't see a strong reliance on us adding pharmacies. The sales reps are obviously trying to engage with clinicians, share the solution, and get buy-in, to ultimately write products into DistributeRx.
Just trying to understand the pharmacy or the specialty pharmacy, is there any particular incentive for them here? On the flip side, obviously under PBMs, they've been pretty disincentivized. Yeah, just trying to understand the play for them.
Yeah. From an independent pharmacy standpoint, you know, we've historically provided direct pricing, which is a little bit better than they can purchase from wholesalers. They're accessing a better price. From Mayne's perspective, historically, the price that we sell direct is better than the price less the distribution fee to the wholesaler. It's a win-win scenario, with the added benefit that the returns from our independent pharmacy network are effectively zero. Therefore it's much more predictable in terms of the gross to net outcomes there. From a PBM standpoint, I mean, there's one lever as a manufacturer to pull with a PBM, and that's to provide a bigger discount. That's a race to the bottom and not a sustainable path.
We have engaged with PBMs in our history at Mayne at times when it was the best possible commercial outcome. Ultimately, you can only pay rebates for so long until you realize you're not making profit. We've engaged cautiously. We try to, you know, be competitive in the marketplace so that we're not excluded. We're not gonna do it to the detriment of our profitability.
Final one from me. Would you ever look to add non-Mayne drugs to the list? I guess just trying to understand if there's a broader opportunity you-
Absolutely. Our manufacturer services team is actively engaging in conversations with a number of dermatology companies right now. But even before that, we have, like I said, we have over 200 different dermatology products that we offer through Adelaide Apothecary. You know, 175 of those are accessed from third parties. Right now we're principally engaging with distributors and wholesalers on generic products. But we're actively working to add a number of brands to our solution as well.
That's great. Thank you. Appreciate it.
Thank you. There are no further phone questions at this time. I'll now hand the conference back to Tom.
Okay. Thank you, Harmony. We have had a number of questions relating to what is the sort of revenue EBITDA growth potential for DistributeRx. I will sort of consolidate them to the obvious question to Aaron Gray, CEO. Aaron, do you wanna make any comments on the potential for this business from a revenue EBITDA contribution scale at this stage?
Yeah, thanks, Tom. There's a couple of ways the company. Obviously, owning DistributeRx means that Mayne Pharma has a share and owns the profits of DistributeRx. To the extent that DistributeRx supports other manufacturers, that whatever that revenue stream, that profit stream looks like would be part of the consolidated business. There's benefits directly to any products that Mayne Pharma sells. We currently sell four major women's health brands. We currently sell 31 dermatology products that are Mayne Pharma products, and we sell over 170 non-Mayne Pharma products through our pharmacy. There's several ways we benefit. We benefit by adding those non-Mayne products and partnering with other manufacturers. We also benefit when Mayne Pharma products are handled by DistributeRx. What we've shown through looking at several studies, the answer to the question as usual in this business is, it depends.
What we've shown looking at several different sets of math is that we have on average about a 14% of revenue, gross profit average by moving product through our channel compared to the alternative. To the extent we don't direct scripts, but to the extent that we provide the best outcome, to the extent that that is the best outcome for the patient and the prescriber, that is what we expect to realize as we migrate more volumes over to DistributeRx.
Thank you. This is an ancillary question, I guess, just on the gross to net that we've called out at the beginning of the call and through the presentation. Does improving the gross to net with DistributeRx result in increases to the amounts payable to TherapeuticsMD under our license agreement with them?
Yes, it would, because improvements to the gross to net would increase the net revenues, which of course increases the gross profit. Whatever the royalty agreement states as a percentage of net revenues, that would also then accrue to the partner who holds the other side of the license agreement.
Thank you. Just again, I think we've covered this, but I will ask it nonetheless, Aaron, maybe for you and Daniel. The investor asks, what level of prescription volume is DistributeRx breakeven or EBITDA positive from a group perspective?
We believe we're not giving guidance, but there's a significant opportunity here. There's significant growth that we're seeing. Break even is not far away for this business.
Thank you.
Actually, sorry, Tom. Just to add.
Go ahead.
Because we didn't add significant incremental costs, the earnings that dermatology or the legacy dermatology business yields is still there, right? We're not further damaging our profitability through increasing the OpEx by launching this business as a group.
Right. There was a question that was directed towards yourself and Meredith, Daniel. If you could explain the relationship, and I think we have covered it, but it's worth reinforcing this, I think. The relationship between CoAssist Pharmacy and Adelaide Apothecary, and what percentage, I assume this may relate to script volume from the investor, what percentage is likely to be directed through the latter?
Sure. CoAssist is a vendor of us. They run an adjudication service. It's best in class. They have a long history in specialty pharmacy, what I consider capital S specialty pharmacy. Very high cost, high touch drugs. We're using a technology-enabled solution that allows for the speed of the benefits check through them, which is far more cost-effective for us at DistributeRx. We expect from a coverage perspective, based on where we are in dermatology, 70%-80% of these products and prescriptions will end up at Adelaide Apothecary. Don't read that as 70%-80% of the dermatology business is going to Adelaide Apothecary, but 70%-80% of the DistributeRx prescriptions will end up at Adelaide or patients will pay cash.
Thank you. If you were to choose one problem in particular on the U.S. channel, which one would you say has been the biggest problem that you are solving with DistributeRx and also entwined in there as sort of the overall disintermediation initiatives at Mayne Pharma? Could you cite one of the, or the problem that you believe is the most pertinent problem for DistributeRx that we're providing a solution for?
Yeah. Look, I'll give you mine. I'm happy for Meredith to provide hers as well. For me, it's patient affordability and predictability. As a consumer, there's nothing more frustrating than going to the doctor, knowing what your copay is gonna be for the visit, getting a prescription, and having no idea what it's gonna cost. There's no table to look it up, that your insurance provides. It's not consistent every month. It can change. That part to me is infuriating as a consumer. That's the biggest hurdle we're solving. Patients are happy to pay cash. They just wanna know what they're expected to pay, and not be surprised when they get to the cash register in a pharmacy. I think that's the biggest one from my perspective.
I could echo that. I think too, Tom, you know, when you think about just how complicated the US healthcare system is, unfortunately, where a patient, to Daniel's point, can't expect to get a prescription and have it easily fulfilled. Where that's why I think sometimes a gap between, you know, Australia and the US where it is so complex that a patient does not know the cost and oftentimes you see, you know, the unfilled prescription. Over 900 million prescriptions go unfilled annually. You look at these numbers and it's like, how are patients not filling their prescriptions? It's due to cost and the unpredictability around that. So when you can get closer to the patient, you allow that control for you as a manufacturer.
Now, you know, separately, as I think about DistributeRx and that opportunity, it truly is to be able to come in and provide that predictability for a patient that clinicians need in order to prescribe and get therapy in patients' hands.
Thanks, Meredith. In the interest of time, I think we've got maybe one to two questions that we can field, before we will need to close today's call. Question, Aaron, and Daniel pertains to the capital light scenario we presented for DistributeRx with a circa half a million dollar investment from Mayne into DistributeRx to date. The investor was interested, you know, overall from a disintermediation perspective over the timeline we presented, knowing what we know and the learned experience we have. Do we have a sense of, you know, what has been the sunk investment over that period to get to where we are today? And is that, in its own right, a barrier for entry for new competitors that they may face to set up something like this?
You know, we've been talking about DistributeRx, Adelaide Apothecary, so on and so forth. If you could maybe make a comment there, either Aaron or Daniel or both.
Yeah, Thank you.
Daniel , please jump in.
Sure.
There's a significant amount of investment. Standing up the pharmacy, getting the licensing, putting in place the software, putting in place the brick-and-mortar, negotiating supply contracts, et cetera. That is all a very complex, very time-consuming thing. A lot of what has been learned and put together as a value add under DistributeRx has been the product of lots of pain that we've learned in a very difficult fashion through every time we've had a. Maybe not every time, but many times we've had a gross to net surprise. We've had unilateral contract term changes. We've had boluses of returns come in. All of these different things have basically helped to sharpen the Mayne Pharma approach towards reaching our patients.
Really, I would say absolutely it's a barrier because it's not just setting up the infrastructure, understanding the interface into the EHR, understanding where the script flows and how to keep it compliant from a legal and regulatory perspective, protect the patient health information, et cetera. It's also then what does good look like and what is an optimal path here. How do we design this? What is a patient likely to pay? What is a walk-away point? Really bringing that expertise of not just the systematic, the patient experience, but also all of the barriers that have happened in the past and how to overcome them. Daniel, something to add?
Yeah, I completely agree. There's a lot of time, you know, effort and funds that have gone into building this business. To your point, Aaron, most of those things that we did from a Mayne Pharma Group perspective were in response to a problem we identified, and we started accruing the benefit of that within the group once we made that change. The specialty pharmacy network is one instance. Our refill adherence programs that we've run historically. There's a number of things that we've done in response to issues that have popped up to benefit the group and, you know, stabilize that business. I also, you know, from my perspective, one of the bigger barriers to this is just time.
You can't do it quickly. To Aaron's point, there's no roadmap for this. There's no clear cut. Like, if you wanna stand up a commercial pharmaceutical company in the U.S., there's hundreds of examples that have done this and done it well. We've paved a new path here. We've done it with a tremendous amount of experience inside of the company from various entities. There's no straight line to get this done quickly, and I think that's one of our biggest barriers to entry. Even if others enter, right? When you look at what we expect this market to be in 2030, this is a $250 billion market.
I think that estimate is conservative, based on the acceleration we're seeing from Eli Lilly and Novo Nordisk down this path. The drug pricing environment in the United States is active and changing rapidly. It all favors, you know, DistributeRx and anybody else that wanted to compete in this space, and we think we're well-positioned to get, you know, more than our fair share here, based on what we've built.
I think from an investor perspective, yeah, we've called out those trends through the deck today. Investors will note the product mix between traditional wholesale and non-wholesale is trending towards non-wholesale for both women's health and derm. It's leading to improvement in the gross margin, and we're seeing accretion in gross margin from FY 2024 through to first half of 2026. I think the growth in margin and then the mix effects leading to higher contribution is self-evident of that strategy starting to bear reasonably strong fruit. With that, Aaron, I'm going to ask you one more very macro question which hopefully ties everything in today in a rather neat manner. That is, you know, how does DistributeRx fit within Mayne's overall strategy?
How should we think about the strategy evolving over the next 12-24 months? Once you've answered that, please feel free to add any concluding remarks, and we'll conclude today's call. Really just a macro strategy perspective.
Yep. Thanks, Tom. I appreciate it. We compete in two spaces that are not super attractive to others. That's part of what makes them attractive to us. Women's health has been largely ignored, and dermatology, especially small molecule medical derm, is unloved from a payer perspective. The traditional pharma model is to sell product with coverage in order to be able to afford to lose money selling product for cash. That's what we've turned on its head. We can make money on cash prescriptions. It fits very well with our strategy. It's been critical for us to be able to squeeze out additional margin points. When you think about the size of the gross to net opportunity that's there, it's $1 billion from fiscal year 2025 just for Mayne Pharma. That number grows as our revenues grow.
That number grows as our product representation grows. The ability to refine a bit, realize what are meaningful gains based on, you know, what may feel like small changes is pretty powerful. There's a lot of companies who deal with, and one can look back at the history of the women's health products. Many companies simply cannot make a go of it because they're not able to get enough coverage. They're not able to get their products out there. There's not enough margin left to promote the products. Given the trends, the macro trends in the U.S. healthcare market, which is higher cost insurance, higher deductibles, more exclusions from formulary, it's certain that there's going to be more patients paying cash. Many patients pay more for a covered script than they would if it were a cash transaction.
That is not an uncommon phenomenon, given all the parties that Daniel showed. From a Mayne Pharma strategy perspective, this is right within our strategy and in fact has been created in part to help the company survive for the spaces that we compete in. There are other areas that suffer from the same thing. Lots of them. It's not just the 800 drugs that Daniel mentioned. There are multiple types of treatment. There's lots of volume that is simply cash script or that is abandoned altogether. This is about an access program. It can improve access for many different products.
It's really, I would say it has opportunities for Mayne Pharma to continue to improve our performance of the products that we have, but also adding other products into the channel, I think presents a very interesting opportunity. Again, thanks everybody for joining. Just a quick wrap up. Really proud of the Mayne Pharma team to get to this point. Daniel and Meredith have poured blood, sweat, and tears into this, along with a bunch of other folks whose names aren't here, but folks, please do know that you are just as important to this. This is a very important moment for Mayne Pharma as we launch what is, yes, a wholly owned Mayne Pharma subsidiary, but it's also a completely new business model for Mayne Pharma. It's an enabler, but it also drives significant value standalone.
Thank you, Aaron. Harmony, I will turn it back to you to close the webinar today. Thank you everyone for joining.
Thank you. That does conclude our conference for today. Thank you for participating. You may now disconnect.