Joining us for this presentation by ANI Pharmaceuticals. I hope you're having a good conference. This is our standard disclaimer regarding forward-looking statements, and I'm pleased to be here to share with you the story of ANI, and where we are and where we're going. So when you think of ANI, we have three different business lines. Our growth is driven by rare disease and generics. That's driving robust, profitable growth, and then our established brands business adds strong cash flow. When you think of overall ANI, and these are 2023 numbers, we had $487 million in sales in 2023, which represented a 54% year-over-year growth, 140% adjusted non-GAAP EBITDA growth, and we ended the year with about $229 million of cash.
Actually, that's the number as of March 31, 2024, and $119 million of cash flow generated from operations in 2023. ANI has delivered robust, strong growth since 2021. When you look at the total company, we have a 35% CAGR from 2021, where we had about $216 million in sales to the current year, 2024, where the guidance is $520 million-$542 million. And then a critical driver of our growth has been our rare disease business, where our lead asset, Purified Cortrophin Gel, was launched in January 2022, and we did $42 million in the first year of sales, and our guidance for the current year is $170 million-$180 million of sales.
So that's a significant driver, significant amount of growth that has come from the rare disease business, and we expect the rare disease business to be the largest driver of growth going forward. When you think of our profitability, you'll see that we've had strong EBITDA and gross profit growth across the same time period. And the growth in EBITDA is driven by the top-line growth, which is driving gross profit growth, as well as operating leverage that we're getting on our rare disease business as we move in the subsequent years since the launch year of 2022. When you look at Q1, this is to recap and then share some new information regarding Q1 performance. We had steady gains in Q1 in our lead rare disease asset, Cortrophin Gel, across the indications that we had launched with, which are neuro-- rheumo...
Sorry, nephrology, rheumatology, and neurology, as well as the new indications of pulmonology and ophthalmology. We also spoke about, you know, the dynamic between Q4 and Q1. So in Q4 to Q1, we had seen a... We see an expected dip in sales, but then we spoke about the strong momentum going into Q2, which was driven, or the lead indicator we shared was that we had the highest number of new patient starts in the month of April, and we're happy to share that we've- that momentum has continued, and we also have the highest number of new patient starts in May, higher than the number of new patient starts in April. So the momentum for Cortrophin continues. We did about $37 million in sales in Cortrophin in Q1.
Total company sales in Q1 was $137 million, which was an all-time record, and also the adjusted non-GAAP EBITDA was $38 million, also an all-time high. We were also able to leverage our new product launch execution for our generics business, where we launched 6 new products, and operational excellence and U.S.-based manufacturing footprint to drive good performance in our generics business. So the second segment, which is generics, established brands, and others, did $100 million in sales in Q1. So that's just a recap of our Q1 performance. It's in line with what we had, you know, what we had expected when we gave the full year guidance of $520 million-$542 million at the on the, at the February 29 Q4 call.
Our full year guidance for 2024, so this is ANI in numbers, $520 million-$542 million in total company revenues. Cortrophin Gel will account for $170 million-$180 million, which is, 52%-61% growth over the prior year of $112 million. And an adjusted non-GAAP EBITDA of $135 million-$145 million was our guidance, and then adjusted non-GAAP EPS of $4.26-$4.67. Let me tell you a little bit about, ANI rare disease and the story behind our lead asset, Cortrophin Gel, and why we believe it's a long-term sustainable growth story for us. So Cortrophin Gel is a purified Cortrophin, a treatment option for patients struggling with certain chronic autoimmune disorders.
It has limited competition with only one other ACTH product in the market, and this product has been on the market for decades and has been the only ACTH product on the market for decades. The long-term sustainability of Cortrophin Gel is driven by the fact that there are high barriers to entry for other products. In 2024, we'll show this on a slide later on, when you add our guidance and the competitor's guidance, you'll see that the total market is about $580 million-$590 million. Prior to us launching in 2021, it was a $600 million market.
But what's even more important to know is in 2017, which is a few years before that, it was a $1.2 billion market, the ACTH category, and that's what we found interesting. That's when we went to Merck and purchased the NDA from Merck and spent all these years to bring it back to market and launched the drug in January 2022. It's approved for multiple indications. We initially launched into the therapeutic areas of neurology, nephrology, and rheumatology, and then recently expanded into pulmonology and ophthalmology. And look, we've reintroduced a much-needed patient and physician choice into the U.S. ACTH market, which for many, many years had, you know, decades, actually, multiple decades, had only had one ACTH product.
So a little more information regarding the lead asset and the momentum that we have with Purified Cortrophin Gel. We see continued prescription growth for the specialties that we launched with, which is rheumatology, neurology, and nephrology. The prescription growth is through existing prescribers and new prescribers, and we have had the highest number of new patient starts, as I said earlier, both in the months of April and then subsequently in the month of May. We're also gaining traction in the three new areas that we have launched over the last year. Last year, we had started with a sales force in pulmonology, a smaller sales force. We've expanded that, so we were in one geographical region. We've added a second geographical region in pulmonology, and we saw the highest number of new patient starts in pulmonology in Q1.
We also deployed a targeted ophthalmology sales force in the latter part of Q1 and early part Q2. That sales force is off and has gained strong traction. And then we launched a 1 ml vial size of Cortrophin Gel during Q4 of 2023, which is the only ACTH therapy approved for acute gouty arthritis. So we're seeing traction in the new therapeutics, these three new therapeutic areas that we've invested in. We're also looking to expand the ACTH market, right? You'll see in a second, the number of patients on therapy today on ACTH are substantially lower than the number of patients on therapy several years ago when the category was over $1 billion. What you'll see is that we have built a strong rare disease platform.
We want to leverage that rare disease platform to expand the scope and scale of our rare disease business, and we'll talk you through, you know, what is the specific priorities as we're thinking through this M&A approach. You see the quarterly cadence on the rare disease revenues on the right-hand side of this chart, and you see that there's a steady climb, and there's just that Q4 to Q1 dynamic that I spoke about, both in 2022 to 2023, as well as 2023 to 2024. But other than that, we've had just a, a strong, performance, growth in, Cortrophin Gel. So the ACTH market, right? This was $1.2 billion in 2017.
In 2019, it was $953 million, and then in the year prior to our launch, it went down to $594 million, approximately $600 million. You see the significant degrowth of -19% and -23%. Well, since we've launched, right, the degrowth first decelerated to -6% and -4%, and then in this year, 2024, if you add our guidance and the competitor's guidance, you'll see, we'll see 8%-10% growth, getting back to the 2021 ACTH category numbers. So we believe that there is, the ACTH market is returning as an overall category back to growth, and that Cortrophin Gel remains on a strong multi-year growth trajectory.
The reason to believe is the number of patients that are on therapy today that can benefit from ACTH therapy are significantly lower than the number of patients that were on therapy many years ago when the category was much larger. Tell you a little bit more about our M&A efforts in rare disease. We're looking at two sets of priorities. Priority one is looking at assets in our therapeutic areas that we currently have sales force going into. So call point synergy, neurology, nephrology, rheumatology, pulmonology, and ophthalmology, rare disease assets in those areas. Priority two are rare disease assets in other therapeutic areas that may require a small sales force, but leverage the rest of our rare disease infrastructure, such as medical affairs, market access, patient support, specialty pharmacy distribution.
So those are the two sort of priorities in terms of indications and types of assets, rare disease. And then second filter is looking at assets, peak year revenue forecast, right? We wanna make sure that we're buying something that is we can absorb with the capital structure we have, which I'll detail in a second. Having patent protection that that goes out, you know, multiple years, right, to give us a multiple year growth opportunity, as well as sustainable growth, and then deal actionability. We have initiated, and based on those, then we'll initiate due diligence and drive execution. We have a strong balance sheet to support the rare disease business development.
This shows, this chart shows evolution of our balance sheet, but if we look at Q1 2024, which is as of March 31, we ended the quarter with approximately $229 million of cash on the balance sheet, gross debt of about $293 million, but a net leverage of half a turn of EBITDA. Yeah, given the last twelve months, adjusted non-GAAP EBITDA was $138 million. So we do believe we have a strong balance sheet to support the rare disease business development.
Turning now to our generics business, the growth in the high single-digit, low double-digit growth that we expect to see in our generics business and have been delivering in our generics business will come from superior R&D capabilities and operational excellence, and let me tell you a little bit more about it. We have a robust pipeline and new product launch execution, right? We've launched six new products in the year. Actually, six new products in Q1, and then a couple of products in Q2 already. We also had a competitive generic therapy approval with the exclusivity attached to it. We're number two ranked in CGT or competitive generic therapy approvals, and a top 15 in terms of number of approvals. These are just in facts that tell you about the strength of our R&D organization and capabilities.
We are increasing our 2024 R&D spend to deliver new launches that fuel the single, high single-digit, low double-digit growth. So that's part one, right? Superior R&D execution. The second part is strong operational backbone and US-based manufacturing footprint. During 2023 alone, our generics business supplied over 1.5 billion doses to American patients. We have an excellent compliance track record across our three manufacturing sites in Baudette, Minnesota, and East Windsor, New Jersey. And in Q1 2024, we expanded capacity in our New Jersey site to add about 16 new process rooms and a new quality control lab. The New Jersey site also had an audit in January 2024, where we had zero 483s. So our track record across our manufacturing sites has been very strong, and we have an entirely U.S.-based manufacturing footprint.
In generics, it's very important to continue focusing on cost excellence, and we're systematically and relentlessly approaching reduction in costs of raw materials, finished goods, and all and have a very lean approach to how we think of a corporate spend for the generics business. Lastly, we ensure that, you know, as an organization, we are nimble and able to respond to opportunities that may arise due to supply shortages faced by and disruptions faced by other suppliers, and we're able to play our role in providing medicines to patients in need.
Look, the reliability and our track record of being able to step in to situations like these, and, you know, we do so by maintaining enough inventory levels of raw materials as well as of finished goods, and are able to move fast as an organization, makes us a partner of choice for key customers. On the right-hand side, you see the trajectory of our generics business on a quarterly basis, and, you know, as I said before, we look to deliver high single digit, low double-digit growth in 2024 and beyond. This gives you an overview of our manufacturing facilities. Two of our manufacturing facilities, which are our original ANI facilities are in Baudette, Minnesota, and then we had a new facility in East Windsor, New Jersey.
Well, new, it's three years old, and it came to us through the acquisition of Novitium, and we've expanded the manufacturing capacity there, as I just spoke about, where we've added, you know, 16 new process rooms, seventeen new manufacturing suites, and a new, QC lab. And we have a strong, track record. Our Baudette, Minnesota site was inspected in November of 2022 and had, you know, a VAI status, which is a, you know, an, an approval status essentially. And then we also had a DEA inspection at the site in August 2023, that also went very well. And the New Jersey site, to reiterate, had a FDA inspection in the January of 2024 and had a strong, uh. And had no 483s, no observations, right?
So US-based manufacturing footprint, we believe it does give us a competitive edge at any given point. You know, for most customers, their distribution centers are, you know, a couple of days away from our, from our 3PL warehouse. I joined as CEO in September of 2020, and we've built an executive leadership team with proven track records and broad industry expertise to drive the rare disease and the generics business. And we have a strong leadership team in place to carry the company's continued journey going forward. So in summary, we have a strong and growing rare disease business, which will be the largest driver of our growth. Our lead asset, Purified Cortrophin Gel, our guidance for the year is-...
$170 million-$180 million of sales, which is 52%-61% growth over the prior year, and we're having focused M&A efforts to expand the scope and scale of our rare disease business. We have a robust and nimble generic segment delivering growth, high single-digit to low double-digit growth, and that's driven by demonstrated R&D excellence and reliability of supply, driven by operational excellence, as well as a U.S.-based, U.S.-based manufacturing footprint with a strong GMP track record. We have strong financial strength, $229 million of unrestricted cash, $119 million of cash flow that was generated from operations in 2023.
When you think of, you know, our guidance for the year, again, $520 million-$542 million in revs, $135 million-$145 million in adjusted non-GAAP EBITDA, and $4.26-$4.67 in adjusted non-GAAP EPS. Last but not the least, we have an experienced and purpose-driven team. You know, I spoke a lot about the, the numbers and the strategic initiatives, but the most important thing that everybody at ANI Pharmaceuticals does is serving patients and improving lives. So thank you for your time, and I'm happy to take questions if there are any. Yeah, Serge?
State of the generic industry, I saw one of your generic competitors. You stated your view of the generic industry. We saw one of your competitors earlier saying there's a deep need for, you know, volumes. Production is low. Supply, manufacturing capacity is low in the U.S. Are you seeing the same thing?
I think that there is, the bulk of drugs that are supplied, generic drugs that are supplied in the U.S. are from overseas. That's clear, and I do believe that we have a competitive edge having, all our manufacturing sites in the U.S., and that does give us a competitive edge.