So I'm Nikhil Lalwani, President and CEO of ANI, and welcome again to the presentation, and thank you for joining us this afternoon. These are forward disclaimers about the forward-looking statements. ANI Pharmaceuticals. We have rare disease business, a generics business, and an established brands business that drives robust, profitable growth. Our purpose is serving patients, improving lives. Our key growth drivers include rare disease business, with Purified Cortrophin Gel as the lead asset, and expansion through focused M&A, which I will speak about later. Our generics business, with enhanced R&D capability and supply reliability, and established brands business. To give you a sense of our financial strength and using guidance, the midpoint of guidance, numbers from the midpoint of our guidance, Q3 guidance, which we had a couple of weeks ago, we're $473 million in estimated revenues for 2023.
That's a 49.5% year-on-year growth over the same period. A 133.6% adjusted non-GAAP EBITDA growth over the prior year, and we have about $193 million of cash on our balance sheet as of September 30, 2023, and we generated year to date about $74 million in cash flow from operations. A quick snapshot of our Q3 highlights. We had continued strong momentum in our lead rare disease asset, Purified Cortrophin Gel, with 22% quarter-on-quarter growth, doing revenues of $30 million. Our strong R&D organization delivered five new product launches, this is on the generic side, and filed three new ANDAs and two new 505(b)(2) applications. We continued responding to pharmaceutical shortages facing the U.S. market through operational excellence and U.S. manufacturing footprint. Just a bit more color around the numbers.
We did $132 million in Q3 revenues, $36 million in adjusted non-GAAP EBITDA, $1.27 in Q3 diluted non-GAAP EPS, and as I spoke about before, we generated $74 million in year-to-date cash. And then our generics, established brands, and other revenues contributed $102 million, which is 43% year-on-year growth. So strong growth across the board and strong financials. These enabled us to raise guidance for the third quarter in a row. We've raised our full- year guidance to $468 million-$478 million of revenues. We've raised the adjusted non-GAAP EBITDA guidance to $128 million-$133 million, and the adjusted non-GAAP EPS to $4.29-$4.57.
Very importantly, our Cortrophin Gel guidance, we increased that from $90-$100 million to $100-$107 million, which represents 140%-157% growth. When you look at ANI over a three-year journey since 2021, we've had very strong top-line growth, going from $216 million to $468-$478 million, compounded annual growth rate of 48%. And this growth has come across our business units, right? You see the rare disease business going from 0 in 2021 to $100-$107 in 2023, to our lead asset, Purified Cortrophin Gel. And then you see the generics, established brands and other, growing 34%-35% between 2022 to 2023. So strong growth across our business segments.
And that growth in top line has also resulted in profitability growth. On the left-hand side, you'll see that there's gross profit increase across the years at a 54% CAGR, going from $126 million in 2021 to $295 million-$305 million at a 63%-63.8% guidance range for gross profit, and this is adjusted non-GAAP gross margin that we're speaking about. And you'll see that the pull-through to EBITDA happened once the rare disease infrastructure was leveraged, right? So we spent about $49 million in SG&A for Cortrophin, our lead asset. And in the first year, our sales were closer to $42 million.
In the second year, we've increased our SG&A about 10%, and our revenues, as we've spoken about a couple of times, going to $100 million-$107 million, right? So, 10% increase in SG&A, almost more than doubling of the sales of the lead asset. And that EBITDA pull-through, you see where we go from $56 million of EBITDA in 2022 to $128 million-$133 million in EBITDA in 2023. Let me tell you a little bit more about our rare disease business, starting with our lead asset. Primary growth engine for the future will be the rare disease business. Our lead asset, Purified Cortrophin Gel, had continued strong momentum in the third quarter of 2023, with record new patient starts and new cases initiated.
We saw growth across all our targeted specialties of neurology, nephrology, and rheumatology, and we also saw continued growth in new prescribers and unique prescribers. An interesting new trend that we've seen is that we'd like to share: there are also prescribers that are writing Cortrophin for the first time that are naive to ACTH therapy. Right out of the gate, we had, you know, we went and spoke to prescribers that were not naive to ACTH therapy, but we're seeing increasing number of prescribers who are naive, who are also writing Cortrophin Gel for the first time. The ACTH market has posted six consecutive quarters of year-over-year growth after many, many quarters of decline.
The company's efforts to increase awareness of ACTH therapy for appropriate patients has helped in this area, and the number of patients, very importantly, the number of patients on therapy today remains significantly lower than the patients on therapy a few years ago, providing opportunity for ANI to serve patients in need. Earlier this quarter, we also announced the FDA approval and commercial availability of the new 1 mL vial size of Cortrophin Gel. When we launched Cortrophin Gel, we launched it in a 5 mL vial size. This is the only approved purified corticotropin indicated for the treatment of acute gouty arthritis flares. We received a specific J-code to support physician administration of the 1 mL vial. The 5 mL vial is self-administered by patients at home.
We have an established and proven rare disease platform with an experienced leadership team and a very experienced sales force too, with a proven track record. Obviously, you see that in the numbers. And the infrastructure and capabilities in our platform is across medical affairs, patient support, specialty pharmacy distribution, and market access, everything that you would look to see in a rare disease platform. And the numbers on the right-hand side show you our quarterly trend. We went from $16 million in the first quarter to $24 million, 50% growth, and then to $29.7 million in the third quarter. Equally important, the ACTH class, there are two drugs in the ACTH class. This class has shown, after many quarters of market decline, year-over-year quarterly unit growth for six consecutive quarters, right?
And this is really compared, you know, pretty much since we launched. We launched in January of 2022. So, and as I said before, that the number of patients being treated today is still much lower than the number of patients that were being treated four years ago, four or five years ago, and so there is significant opportunity for ANI to serve patients in need. We will expand on our rare disease business through M&A. We've been looking actively to buy a rare disease, another rare disease asset or assets. We raised about $86 million earlier this year through a secondary equity offering, right? The net proceeds were about $80 million.
The first priority, and this just shows you the systematic approach we've taken, priority one is to look for assets in rare disease assets, in our priority therapeutic areas of neurology, nephrology, rheumatology, and pulmonology. Priority two is to look at rare disease assets in other therapeutic areas that can leverage the rest of the infrastructure we have, the specialty pharmacy distribution, the market access, medical affairs, patient support, hub services, et cetera. We then look at the assets. We filtered it by assets' peak revenue potential, then looked at the patent protection, you know, and wanting it to give a significant runway for that, and also the deal actionability. We've initiated pre-diligence on several assets, and we'll look forward to working towards deal execution.
But this is our systematic approach to expanding the scope and scale of our rare disease business. Let me tell you about our generics business. Superior R&D capabilities and operational excellence helps us drive growth in generics. If you look at the numbers on the right-hand side, you'll see that our generics business went from, you know, a quarterly run rate of $53 million, starting the year and ending in Q3 of 2023. We've done $70.6 million in the third quarter, right? So even quarter-on-quarter growth, you see from $63 million to $70 million, and that's on the back of a strong R&D engine and operational excellence. I'll tell you a little bit more about it. So we have a superior pipeline and new product launch execution engine. We've increased the R&D investment with a focus on niche opportunities.
We filed 6 new ANDAs and three 505(b)(2) NDA applications. We've retained the top 12 ranking in number of NDA approvals. We're number two in competitive generic therapy approvals in the U.S. And our key, you know, we have—you have listed here the key 2023 launches. In generics, it's also very important to keep driving cost excellence. We have innovative strategies to reduce cost of raw materials and finished goods, lean and entrepreneurial mentality towards all spend, all corporate spend. And we also have an analytical facility in Chennai, India. While our manufacturing is entirely U.S.-based, we have an analytical facility and development facility in Chennai, India, that we leverage with over 60 skilled colleagues.
We pride ourselves and keep working towards retaining our reputation as a reliable supplier, and we ensure reliability of supply by having a strong compliance and audit history, maintaining adequate inventory levels, and also the fact that we, at any given point, you know, are two days away from any distribution center of our customers, right? Because both our manufacturing facilities are in the U.S., our sites are in the U.S. We have the ability to respond to shortages arising from supply chain disruptions. We have done that consistently throughout 2023 and even prior to that, and the timely response that we've done makes us a partner of choice for our customers. This shows you our U.S.-based manufacturing footprint. There are two main sites in Baudette, Minnesota, and East Windsor, New Jersey.
You see that in Baudette, Minnesota, we have two sites, two plants there. One is a controlled substances facility. We can also do hormonal products there, which is the facility in the blue, and then we have the Main Street facility where we, which does the larger volume of manufacturing that we do. On the right-hand side, you see the East Windsor, New Jersey facility. We're proud to share that we have a strong GMP track record with successful audits across all of our facilities, and it shows you the status in green, highlighted in green, for our manufacturing facilities. We've also invested recently in expanding the New Jersey site to support the growth of our generics business, and we see that capacity coming online in about early 2024.
We've invested about $5-$6 million through the year in the year-to-date CapEx. You'll see that for the expansion of the New Jersey site. That's the experienced leadership team we have, with proven track records and broad industry expertise, the ability to drive both the rare disease business, which is the primary growth driver for the company, as well as the generics business. So in summary, we have a strong and growing rare disease business. Which is expected to be the largest driver of future growth. Our lead asset, Purified Cortrophin Gel, forecasted at $100-$107 million in 2023 sales, with significant opportunity for future growth and focused M&A efforts to expand the scope and scale of our rare disease business.
We have a robust and nimble generics business delivering growth, through demonstrated R&D excellence in filings and launch execution, and providing reliability of supply with U.S.-based manufacturing and a strong GMP track record. Our financial strength is highlighted by or a few highlights of our financial strength is the $193 million in unrestricted cash on our balance sheet, $74 million of year-to-date cash flow generated from operations. The $473 million in estimated revenue from in 2023, representing 49.5% growth. That's again at the midpoint of our 2023 guidance. $130.5 million in adjusted non-GAAP EBITDA for 2023, again, representing 133.6% year-over-year growth compared to the midpoint of guidance. And we have an experienced, purpose-driven team.
Dedicated employees with deep expertise, as I mentioned, in rare disease and generics and established brands. Purpose-driven, serving patients, improving lives, and strong cross-functional collaboration, driving success. To end, we just recently celebrated our 10-year anniversary of being listed on the NASDAQ. That's me with the ANI team ringing the bell. With that, happy to answer any questions you all may have, and thank you again for your time.
If you have any questions, please raise your hand and I will bring the microphone to you.
Sure. I can hear you.
It's for the brook. Yeah.
What is the IP protection for the Cortrophin Gel?
Yeah. We have—t his drug was approved in the 1950s and was taken off the market in the 1980s. ANI bought this drug from Merck and has spent time and effort over 5 years to bring the drug back to the market. We have, to this point, from an IP perspective, obviously, for a drug that was approved in the 1950s, there's not IP from the 1950s, but we are taking steps to have patents around our product. Yeah. Thank you.
Any more questions? Then this concludes our session. Thank you, everyone.
Thank you, everybody, for your time.