Thanks, Matt. And good morning, everyone. Thank you for your time today. Yeah, look, as Matt touched upon, Avecho has spent really the last six years driving a proprietary cannabidiol capsule towards TGA registration in Australia, and the final major piece of data we need to submit to the TGA is a pivotal phase III clinical trial result for the management of insomnia. Now, a couple of weeks ago, we announced that we had completed recruitment of all the patients that we needed for an interim analysis, which will be the first look that we get to as to how the trial and the product is working. We will get the results of that interim analysis in June, which will be huge.
Look, today I'm just gonna give you a brief overview of the product, the unique commercial opportunity that we're targeting, the large pharma partner that we've already locked in place, and the impending phase III result, which makes for a very exciting time for both the company and our shareholders. Sorry, I'm just trying to flip the slide. This is a very brief snapshot of where we sit at the minute. We've got sufficient cash in the bank to get us to and past our interim analysis in June with a lot left over. With success in June, we anticipate a number of attractive opportunities for us moving forward. Now, we've got a large allocation of options at the moment.
These all expire unfortunately prior to the result of our interim analysis, which will be in June. The options expire in May. Now, the stock itself has seen an increase in interest over the last year after the pharmaceutical validation of Sandoz licensing the product, and we expect to see this accelerate over the coming months as we head towards this interim analysis, as there are not many phase III clinical trial companies valued at AUD 30 million, and even fewer with a pharmaceutical company backing them prior to results being available. At this stage, a re-rate looks inevitable.
Very highly experienced management and board across, you know, averaging over 25 years experience in healthcare, biotech and related industries, with proven track record spanning early-stage biotech exits all the way through to some of the largest pharmaceutical companies in the world. Truly, it is not by chance that we have managed to develop a proprietary world-first product and progress it all the way into pivotal phase III trial and pharmaceutical licensing within 5 years. This is my one slide, I guess, summary for those of you new to the story. As mentioned, we have developed a proprietary cannabidiol or CBD capsule for insomnia. Now, the capsule is enhanced using our own technology called TPM. TPM increases drug absorption, so you have products that work better.
This capsule is in a pivotal phase III clinical trial right now with an indication of insomnia. Most of you will know what insomnia is. I guess the thing that not everyone recognizes is how big an indication it is, so 10%-30% of the population. There is a unique opportunity in Australia, which is both strategic and lucrative, which we'll talk about, around TGA approval of this product. We will never run out of patients. In Australia alone, there's already 9.5 million people with sleep problems. Around the world, it's over 200 million. I guess the luxurious piece for me now about this story is that last year, we licensed this program to Sandoz, so the world's largest pharmaceutical generics company.
Sandoz heard the story you're about to hear, and they agreed, and on the back of that, they licensed the rights to Australia with very, very attractive commercial terms for us. Look, there's a whole lot of upcoming milestones, which are big-ticket inflection points. We'll have our interim analysis results in June. We expect to see further licensing deals for different geographies, and then there's phase III trial completion and TGA submission and all the good stuff that biotechs strive for over many years. Before talking about the product, just a couple of additional points, I guess, on the indication. As I said, major problem worldwide now, insomnia. You all know what it is. As I say, 10%-30% of the population, over 200 million people around the world.
The additional bit to add, I guess, is that in addition to being a primary indication all of its own, insomnia is also a symptom of a range of other disorders, very specifically mental health and psychiatric disorders. The problem when we've been talking to U.S. psychiatrists is that the first thing that they would ideally do with their depressed patients is treat their sleep, but they are unable to prescribe sedatives for depressed patients for fear that they'll use those to try and self-harm and maybe commit suicide. You can't overdose on CBD. It's a very, very safe molecule and potentially adds a lot of value beyond straight insomnia, but to the growing mental health market around the world. Which now brings us to cannabidiol. CBD is the major non-psychoactive component of medicinal cannabis.
Very clear from the outset to say we are not a cannabis company. We are not medicinal cannabis. We are biotech pharma, and we are building this product for pharmaceutical registration. At the moment in the world, there is only one pharmaceutical CBD product. It is called Epidiolex. It's the product pictured here. It was developed by GW Pharmaceuticals in the U.K., and it is approved for rare childhood epilepsy. It's an orphan drug, which gives you a fast track for FDA approval, but it also means once you're approved, you don't have many patients to treat. Now, the really interesting thing about Epidiolex is that despite being rarely prescribed, it was acquired, or GW Pharmaceuticals was acquired for $7.2 billion in 2021. This was a big wake-up call because we'd been telling the industry forever that we needed to develop pharmaceutical cannabinoids.
No one believed us. This acquisition happened, and suddenly everyone turned to look at pharmaceutical CBD, but we had a multi-year head start on everyone. Now, Epidiolex itself is interesting to me for three reasons. The first is it's a terrible product. It's just CBD dissolved in sesame oil, with alcohol and strawberry flavor. No one wants to drink sesame oil as a medicine. We all want tablets and capsules and pharmaceutically recognized dosage forms. The second piece is that the absorption of CBD from this product is poor. Epidiolex states that only 6% of the CBD from this product is ever absorbed into your bloodstream, so you're wasting 90% of what you purchase. Lastly, GW Pharma did randomized placebo-controlled trials to prove that CBD would work for epilepsy.
What they also proved is it has a common side effect of sleepiness. They've already proven it works for sleep, and their side effect is essentially the treatment for my indication. Now, there are no pharmaceutical CBD products approved anywhere in the world for insomnia, but sleep remains one of the most common indications that consumer and medicinal cannabis CBD products are prescribed for. This is really the reason we stepped into the space. I'm not sure if you can see this cursor or not, but as I say, we have this proprietary technology called TPM, which increases drug solubility and drug absorption. Now, what you're looking at in this vial here, this is CBD. The drug itself is an oil. This vial is mostly water. Oil and water don't mix, and so you're left with this insoluble precipitate.
This vial is exactly the same, just with a little bit of our TPM added. Our TPM forms these nanoparticles that encapsulate and solubilize the drug. Whenever we see this kind of profile, it doesn't matter what the drug is, we know we can increase drug absorption. That's exactly what you see here in this graph. This is the absorption of CBD into the bloodstream of dogs in the U.K. at the same lab that GW Pharma did all their dog work for Epidiolex. This blue line is the CBD appearing in the bloodstream after a single dose of Epidiolex. The red line is Epidiolex again, just if you dissolve some of our TPM into it. The addition of our TPM to Epidiolex increases absorption by about 400%.
Once we saw this kind of data, we set out to build a better Epidiolex. Epidiolex 2.0 product in a physician patient-preferred dosage form, so we turned it into a capsule. Full pharmaceutical capsule, three-year stability, increased absorption over Epidiolex and the other CBD products for commercial differentiation and patent protection and better differentiation. To shoot for a huge indication, so not an orphan drug that doesn't have many patients. Shoot for an indication that affects 10%-30% of the planet. Remember, this product was acquired for $7.2 billion. Now we've advanced that product all the way to a phase III clinical trial. Now, I know this is a wall of text. You don't have to read it. I'll just walk you through a couple of the key items.
We built the world's largest randomized placebo-controlled insomnia trial looking at cannabidiol, this is the biggest one in the world. It was developed using the FDA and the European guidance documents so that we could submit it to the FDA and Europe and all the rest. There's really three things to draw your attention to. We have three treatment groups. We've got placebo, two doses of CBD. Patients take the capsule every night before bed over eight weeks. We have two primary endpoints, the insomnia severity and sleep efficiency. We only need one of them to work, the way we've built the trial, for it to be a successfully completed phase III trial. We've got two bites of the cherry here, and both of these are different aspects of sleep.
If CBD works one way, one of them will catch it. If it works the other way, the other one will. It gives us two bites of the cherry for success. The other piece is we have an interim analysis, which is a huge deal. We were targeting 519 patients in total. After 210, the statisticians would look at the data and say, "Look, a, there were two outcomes of that.
First was futility, where they say, 'You know, despite all your best efforts, CBD is not working for sleep. Save shareholder money. Don't dose another 300 patients, and look for an additional indication that CBD will work for." What was more likely is they would say, "Yes, CBD is working, and based on how well it's working, you need to dose another 300, 350, 400, whatever it is." This would allow us to amend the patient numbers to hit exactly the number of patients we require for statistical significance and success. It's a huge ticket item. The big one is that, for a trial like this, we're all scared of the placebo effect. We know every patient on the trial will improve, even when they're not on study drug, because trials like insomnia or anxiety or pain where you ask patients how they feel, everyone improves.
The art is to design a trial in such a way that you can see your drug groups improve more than your placebo group. What we have is what's called a placebo run-in. Everyone on our trial is on placebo for the first two weeks. They just don't know they're on placebo, and we assess their sleep at the end of that two weeks, and if their sleep significantly improves, thanks for your time. You're off the trial. We remove all the high placebo responders before we start recording the data, and that is gonna be the differentiating feature that helps this trial succeed. Now, this Australian opportunity, it's rare that you'll hear an Australian biotech CEO talk about Australia. We don't care in general because it's only 27 million people. We're always focusing on the U.S.
There's a unique opportunity here which is too good to refuse. Essentially what it is that our government now allows CBD to be registered as an over-the-counter medicine. Now, they've done this in response to rampant over-prescribing of the medicinal cannabis sector, which they are very angry about, to incentivize drug development. They've said if you do your phase III clinical trials, you prove CBD works, and you get it registered with the TGA, they would allow it to be registered as an over-the-counter medicine. What's an over-the-counter medicine? That's one of those medicines you can walk into any pharmacy in the country and buy direct from the pharmacist. You don't need to pay to see a GP, pay to get a prescription. Direct access to the entire adult population of the country.
Huge commercial advantage over prescription medicines, including medicinal cannabis, and Australians spend AUD 5 billion a year on OTC. When the government announced this, a bunch of companies ran for the opportunity. We were the only biotech. Everyone else was medicinal cannabis. They all failed, and we are now subsequently the only one left in the race. With that in mind, given how desperate the TGA is for one of these to succeed, they. We went in and met. We walked them through our phase III protocol and submission strategy. They said the whole program was well thought and robust. They had no recommended changes, so we could start knowing that if the trial works, it would be acceptable. Subsequently, New Zealand has copied it. Canada is looking at the same thing.
If we are successful, this product becomes the second-registered pharmaceutical product behind Epidiolex. Now, this Australian opportunity alone, so when there's 10%-30% of the population, there's 9.5 million potential patients in Australia with sleep problems. But because you don't need a prescription, we know the pain patients will walk in and buy it. We know the anxiety patients will walk in and buy it. Menopause, osteoarthritis, just cannabis curious. There'll be a whole lot of patients that walk in and buy this product. Now, initial independent forecasts were that this product makes $125 million year one just for Australia. Subsequent business cases, including Sandoz's, are much higher. Globally, insomnia is above $5 billion. When you think that this could be thrown at mental health, mental health is already above $370 billion around the world.
We're building this product at the perfect time. Which brings us to my new partner. As investors now, you have the luxury of knowing that the world's largest pharmaceutical generics company has done due diligence on everything that I just said. If you don't know who Novartis are, Swiss listed multinational, market cap $34 billion, over $11 billion in revenue, 1,500 approved medicines, and they treat over 1 billion patients a year globally. Now my product is in their stable. This is the company that will be pushing my product. I could not have asked for a better partner. The really great thing for you to understand is that this was a big deal for them.
They did four months of due diligence because Sandoz don't do cannabinoids, Sandoz don't do drug development, and Sandoz don't do branded medicines, and this is all three of those things. The reason they could not afford to say no was that their business case says that this could be the largest pharmaceutical product in Australian history, which is obviously an exciting thing for all of us. The deal that we did, Sandoz got the exclusive rights to Australia. They do have first right of refusal to global territories, but for the rights to Australia, they gave us $3 million upfront last year, which was about AUD 5 million. There's $16 million of milestone payments prior to the first commercial sales. We'll get 14%-19% royalties on net sales.
Avecho controls the manufacturing, so Sandoz places an order with me and pays me, and then I'll pay the manufacturer. I get a 7.5% management fee on all the manufacturing. Their year one order is gonna be about $64 million, so I'll add 7.5% on top of that. Sandoz's conservative business case sees Avecho getting $20 million-$50 million every year that this is on market just for Australia. Obviously transformational, but Australia's really just the start. The first pharmaceutical deal is always the hardest. Now that that one's done, the rest of the world knows. The U.S. is 30 times bigger market, Europe's 20 times, China's 10 times. This is where the conversation will start, and I am in conversations with a whole range of pharmaceutical companies for a whole range of-