Good afternoon, everyone. My name is Dave Risinger, and I cover diversified biopharmaceuticals for Leerink Partners. It's very much my pleasure to introduce the next session with ANI Pharmaceuticals. I wanted to welcome the company's CEO, Nikhil Lalwani, who has joined us today for the discussion. You know, in engaging with you, Nikhil, it's been interesting to learn more about your background and how you've been able to drive such strong performance at the company. So before you go into your brief presentation, if you could just share a little bit more on, you know, your background and the change that you've been able to affect at the company, and then we can take it from there.
Perfect. Good afternoon, everybody, and thank you for joining the session with ANI Pharmaceuticals. Thank you, David, for having us. You know, just quick background on myself. I've been President CEO of ANI since September of 2020. Prior to joining ANI, I held multiple leadership roles at a global biopharmaceutical company called Cipla, and prior to that, I was an associate principal at McKinsey & Company. I'm thrilled to share with you about ANI, but of course, we'll start with our standard disclaimer on Forward-Looking Statements. ANI. Our purpose is to serve patients, improve lives. We have a rare disease and generics business that are our key growth drivers and an established brands business that generates stable and strong cash flows.
When you look at the size and scale, we did $487 million in revenues last year, which was about a 54% year-over-year growth and a 140% in adjusted EBITDA growth over the previous year. We generated $119 million of cash flow from operations and completed the year at about $221 million of cash on the balance sheet at the end of the year. So a strong balance sheet, financial strength to support the key growth drivers, the rare disease business, which has Purified Cortrophin Gel as the lead rare disease asset, and our generics business, with our enhanced R&D capability that drives the new product launch execution and supply reliability.
Our 2024 guidance for revenues, we guided to $520 million-$542 million for total company revenues, which is 7%-11% growth over the previous year. Cortrophin Gel, our lead rare disease asset, which we will tell you more about. We estimate, we give guidance for $170 million-$180 million of sales, which is 52%-61% growth over the previous year, and our adjusted Non-GAAP EBITDA guidance was $135 million-$145 million, and adjusted Non-GAAP EPS guidance was $4.26-$4.67.
When you look at the growth curve or the revenue growth curve for ANI, you've seen that we've delivered consistently since 2021, 2021, a 35%, compounded annual growth rate, and there's strong momentum across all our business segments. We have a 105% CAGR across our rare disease business since launch in 2022, and for our generics, established brands, and others, an 18% CAGR since 2021. When we break down the year-on-year growth for our business between 2023 and 2024, you'll see the rare disease primary growth driver with Cortrophin Gel growing from $112 million in 2023 to $170 million-$180 million. And then generics, which did $269 million in 2023, having high single-digit, low double-digit growth expectations in 2024.
Established brands, you know, we had supply tailwinds that we benefited from for the full year in 2023, and we've assumed that these supply tailwinds will only continue. These supply tailwinds that we are seeing will only continue for the first quarter in 2024. That's what's assumed in the guidance. So our total for generics, established brands, royalties, and others is 350-362 for a full company revenue guidance of $520 million-$542 million. But let's tell you more about rare disease. ANI's primary growth asset, primary growth engine with our lead asset, Purified Cortrophin Gel. This is a product we launched in January 2022. We continue to see strong momentum for this asset in our initially targeted areas.
Initially, we targeted three specialties for this asset: neurology, nephrology, and rheumatology. We've seen record number of new patient starts and new cases initiated in the fourth quarter of 2023. We also see growth in the new cases initiated, as well as, as I said, new patient starts. We've also seen growth across both the existing prescribers and new prescribers... In fact, the new patient starts accelerated in Q4, and we recorded our strongest sequential growth, sequential growth rate in new patient starts in the Q4 of 2023. So just strong momentum within the initially targeted specialties at launch. We've also expanded into new areas. You know, in the second quarter of last year, we launched a small sales force in pulmonology. In 2024, we're expanding that to a second region. We're also launching a small new pilot sales team for ophthalmology.
That's a new area. In the fall of last year, we also launched for the first time a 1 ml vial for the treatment of acute gouty arthritis flares. And in fact, we've received a specific J-code, and physicians can now administer these to patients in outpatient center settings, or, of course, for the appropriate patients presenting with these types of flares. We've also continued to improve ACTH awareness. Since we launched, for seven quarters consecutively, we have had unit growth quarter-on-quarter, year-over-year. And that is a significant achievement when you contrast it with what had happened prior to our launch, where there had been quarter-on-quarter decline for several quarters. We're now in a position where we can leverage our rare disease platform to expand the scope and scale of our rare disease business.
On the one hand, we can look at the initially targeted specialties of neurology, nephrology, rheumatology, and find assets through M&A and in-licensing that can add, you know, that our sales force can carry. We can also find assets, and we're also actively looking for assets, that can leverage the rest of our rare disease platform, which includes specialty pharmacy distribution, market access, medical affairs, and other parts of the rare disease operational backbone, patient support, that can be leveraged for therapeutic areas that may be outside of the ones that I just spoke about. So the full year guidance for our lead asset is $170 million-$180 million, a 52%-61% growth over the prior year.
Rare disease, we believe, will be the primary growth driver and the source of largest growth for ANI going forward. As we talked about, that, you know, we are entering into new therapeutic areas. So pulmonology, we're expanding our sales force. We're adding a second region. We're also adding a small targeted sales force in ophthalmology for Cortrophin. We're also taking steps, this is something I haven't spoken about, to enhance the support and remove pain points for patients starting on ACTH and their healthcare providers. So we're investing in R&D. We're investing R&D dollars and in medical affairs to support the patient journey. And then finally, as I was speaking about, we're looking actively to expand the scope and scale of our rare disease business through M&A and in-licensing.
Let's turn next to our next key growth driver, which is our generics business. The key drivers for our generics business are our superior R&D capabilities and the operational excellence that drives the growth in generics. Our robust pipeline and new product launch execution enabled us to file 20 new products in 2023 and launch 11 products in the same year. We retain a top 12 ranking in the number of ANDA approvals and the ranking of second in the number of competitive generic therapy approvals. We believe R&D is a key area of strength for our company and a key enabler of our future growth. We also have a strong operational backbone and a U.S.-based manufacturing footprint that enables us to be a partner of choice for our customers and for patients in need.
In 2023, we supplied over 1.5 billion doses to patients in need across the U.S. We have an excellent track record with the FDA across sites. Most recently, our site in New Jersey had both a pre-approval inspection as well as a pharmacovigilance inspection, and they passed both with zero 483s and no observations. We've also initiated a capacity expansion at our site in New Jersey to support the growth of our generics business, and that capacity expansion is almost complete and will be operational in this quarter. We remain focused on cost excellence, both for our raw materials, but also on all corporate spend. As you know, driving cost excellence is also an important part of being successful and sustainable in the generics business.
Lastly, we've been able to be nimble as an organization, and our operational excellence has enabled us to serve patient needs when there are drug shortages, right? We've heard a lot about the drug shortages facing the U.S. market, and we've done our part, leveraging our U.S.-based manufacturing footprint and operational excellence to address these shortages. Our guidance for 2024 is to deliver high single-digit, low double-digit growth over the previous year of $269.4 million. In summary, we have a strong and growing rare disease business, which will be the primary driver and the largest expected driver of future growth... Our lead asset is forecasted to do $170 million-$180 million in sales in 2024, which is 52%-61% growth.
We also have a robust and nimble generics business, where that business will deliver high single-digit, low double-digit growth on a $270 million-ish base. So we have strong financial strength to back both these key growth drivers. We have $221 million of unrestricted cash as of December 31st, 2023. We generated $119 million of cash from operations in 2023, and we are looking forward to taking this journey forward to achieve our purpose of serving patients, improving lives. Thank you.
Great. Thanks very much for that overview. So you obviously have had tremendous success with Cortrophin and good momentum continuing. But to step back, could you just contextualize for us the ACTH market units sold in 2023 versus, you know, where it was at the peak, so we have a sense for, you know, the opportunity to continue to build that market? And obviously, you can even go beyond the peak, but just if you could start by contextualizing that, and I have some follow-ons.
Sure. Thank you, David. So, let me just start with sales. In 2017, the ACTH market was $1.2 billion in sales. In 2019, it was about $950 million in sales, and then in the year before we launched, which was in 2021, it was $590 million approximately in sales. Since we've launched in 2022 and 2023, and obviously, I'm making assumptions for 2023 based on what the competitor said in their Q3 earnings, the market has finally flattened. The decline has stopped in terms of sales overall, and it is now about $560 million, both in 2022 and 2023. With us doing $42 million in 2022 and then a hundred and twelve million in 2023.
Then going back to your question on number of units, you know, there are two different sources of data, but if you look at units and compare it with 2019, which is the year in which the overall market sales was $950 million, the number of units is right around half of what the units are today, or were in 2023. And when you compare with number of patients, and this is, of course, based on claims data, one source of claims data. When you look at the number of patients, our best understanding is that the number of patients that are on therapy are substantially lower than 25% of patients that... Sorry, substantially lower than 50% of patients that were on therapy at the time of the peak in 2017.
So overall, we believe that there are several patients in need and a large opportunity to expand the ACTH market and continue serving patients in need.
Excellent. Thank you very much. So with respect to your efforts to drive the franchise, could you please provide some more color?
Sure. So I think we're, you know, we're doing a few different things to drive the Cortrophin Gel franchise. We obviously believe that we're in early days for this franchise, and the steps we're taking include... Well, number one, expanding our sales force, and we're expanding our sales force in two areas. One is in pulmonology, where we had launched a small sales force in the previous year. We're expanding that and adding another sales force or another geographical region for pulmonology. Second, we're launching a small sales force for ophthalmology. In addition to these two steps, we're also doing some investments in R&D and medical affairs to one, delineate the... And we're working with top physicians and scientists to delineate the Cortrophin Gel activity and mechanism of action to support treatment decisions.
Number two, to continue to support the patient journey and enhance patient convenience and remove pain points. These are steps that we're taking to invest in the Cortrophin Gel journey and the Cortrophin Gel franchise. I think beyond that, for our rare disease franchise, we're actively looking for M&A and in-licensing efforts to expand the scope and scale of our rare disease business.
Great. That's very helpful. So looking ahead, what are the biggest growth opportunities by disease state or area?
Yeah. You know, we're fortunate that there's, you know, just given the amount of headroom we have in the category and where we are, you know, going back to your first question, David, we believe that there is opportunity across both our initially targeted specialties of rheumatology, nephrology, neurology, as well as our newer areas of pulmonology, ophthalmology, and gout. And again, when I say gout, I mean acute gouty arthritis flares. So we think that there's opportunities across both. If you take another lens with, there's growth opportunities both with new prescribers as well as existing prescribers. There are, you know, we've seen tremendous uptake with new prescribers that are naive to ACTH therapy too, and that they are seeing the value of ACTH therapy for appropriate patients in need.
Excellent. So with respect to acute gouty arthritis, as you mentioned, it's a 1 ml presentation versus the regular 5 ml. So could you describe the pricing differential and comment on the sales potential for this indication?
Sure. So, the listed price is for the 1 ml vial $6,995 or right around $7,000. And then, you know, in terms of the presentation, first of all, we are the only ACTH therapy or Purified Cortrophin Gel is the only ACTH therapy approved for the treatment of acute gouty arthritis flares. I think we've launched with the 1 ml indication, 1 ml vial, because that is the presentation that is most appropriate, given the dosing that is needed for acute gouty arthritis flares.
We have been able to secure a separate J-code for the, for the 1 ml vial and, been able to, you know, set up so that physicians can now administer the drug to patients that present with that need, of acute gouty, gouty arthritis flares in the outpatient setting. So, you know, it's early days in the, in the launch for this product, for, for this presentation, and we look forward to sharing more as the launch evolves.
Excellent. And then just thinking about the competitive dynamics, Mallinckrodt has been through a lot, but they obviously are recognizing that they are losing share. So could you just comment on, I don't know, their activities and whether they're changing any of their behavior?
Yeah. Look, our competitor is focusing on, you know, increasing awareness of their ACTH therapy. And as I said before, that, you know, the real opportunity for both companies is to continue serving more patients, right? The number of patients being treated today with ACTH therapy, appropriate patients being treated with ACTH therapy, is substantially lower than where it was many years ago, or sorry, a few years ago. And so I think both companies are really just focused on increasing awareness of their individual ACTH therapies. Yeah.
Okay. And then you, you touched on it, but could you expand a little bit more on, you know, your vision for rare disease M&A?
Yeah, sure. Yeah, this is something that we've, we're spending a fair amount of time on. We want to expand the scope and scale of our rare disease business. You know, priority one for us is to find assets that, leverage our current, current sales force. So they would go into the specialties primarily of neurology, rheumatology, and nephrology. Of course, we've also added, ophthalmology and pulmonology. So those are the, you know, sales force, sort of, leverage, right? So that's our priority one.
We've also been looking, and we've opened up the aperture a little bit to look at priority two assets, which is rare disease assets that leverage the rest of our rare disease backbone, which is specialty pharmacy distribution, market access, medical affairs, hub, patient support, so the rest of the, you know, the backbone of our rare disease business. We are looking for assets that are commercial or close to commercial, that have patent life that gives us at least a few years of runway, you know, and exclusivity. We are also looking at assets that, you know, add meaningful scope and scale, so from a size perspective, and then, of course, we want them to be actionable. So that's how we think about rare disease M&A.
Okay, thank you for that context. So then, maybe we should pivot to the generics business-
Sure
... which continues to perform very well. And diversification of your operation is obviously a key strength. So could you speak to that level of diversification and then also talk about the pipeline's diversification as well?
Sure. So, and thank you for that question. Yes, David, I agree that our diversification of our generics business is a real strength. We have over 100 product families that we sell for a total of $270 million in sales and or $269.4 million in sales in 2023. Our largest product is, you know, approximately 3% of total company revenues, approximately 6%ish of the generics revenues. And so, you know, there is no, you know, limited concentration or lesser concentration. And then when you, when you look at our pipeline, you know, we launched 11 products last year. We filed 20 new products.
You can expect that, you know, we will launch between 10-15 products each product families each year, and that'll support the growth aspiration that we have of high single-digit, low double-digit growth for our generics business. I think, you know, for those that are newer to the generics industry, you know, there's the base business that we have, and that sees a certain amount of erosion. You've obviously heard from the larger players that the erosion that folks are seeing is mid single-digits or mid to high single- digits.
And, you know, we factored that in and then say to deliver high single- digit, low double-digit total growth, the value from our new launches, which is basically, if I take 2024 as an example, value from launches in 2023, annualize in 2024, plus the value from new product launches in 2024, must make up for that erosion and then grow. And we've also been doing this for a while, and can deliver, you know, high single- digit, low double-digit growth. For context, in 2023, we delivered 28% growth versus the prior year. So we did $269.4, the year before was $210. And, you know, at that point, we did benefit from some supply tailwinds.
But to be clear, our 2024 guidance of high single-digit, low double-digit growth does not take into account any benefit from supply tailwinds to deliver the number.
Can you just talk a little more about the supply tailwinds? How many products, you know, what's the magnitude? Any additional perspective you can provide?
Yeah. I mean, it impacted multiple products positively in 2023, and, you know, we think that. And again, you know, I think the larger players in the industry and the customers are the best sort of, you know, commentators on this, and they've said that this is a trend, that the macro trend will continue for some period of time. And we need to play our part, right, of as a U.S.-based manufacturing player and, you know, to serve patients in need and address these shortages and help address these shortages whenever we can. Having said that, there is variability, and so in 2024, our guidance, total company guidance and our generics guidance, of high single-digit, low double-digit, does not assume any benefits from supply tailwinds.
Excellent. And then maybe you could comment also a little bit beyond 2024.
Sure.
You obviously have... And, I guess you could approach it however you'd like, but I'd love to hear about the generics business specifically, and then, you know, the company in total as well.
Sure. So, I think that, you know, beyond 2024, we're gonna continue evolving the scope and scale of our rare disease business, as I told you, with our lead asset. You know, you can see already by the end of 2024, and going into 2025, you know, more than 50% of revenues of ANI will come from branded products, and, you know, a big component of that will be rare diseases from the rare disease business. And that is very much the direction in which we are headed. Having said that, our generics business continues to deliver strong growth and is a key growth driver for us, and we'll continue to invest in fueling that growth. To fuel the generics growth of high single-digit, low double digit, we need to keep investing in R&D.
And you obviously, you've seen that in the guidance for this year's numbers. We are investing more to support growth, support new product launches from a, you know, from the generics business. We're investing more in R&D, and we'll continue to do that, and that'll be the key sort of driver of, growth of the generics business.
Excellent. And then, we're almost out of time, but one final question on, you know, something you touched on, is R&D for Cortrophin. I'm sure you may not want to reveal all of your secrets, but, if you could provide some more color on that, that would be helpful.
Yeah, we try to find a balance between sharing information that is helpful for investors and not showing our competitor all our cards, especially now that they probably don't have to comment as much publicly. So, yeah, we'll come back and share more when we have more to share.
Okay, excellent. Well, that's serving you just fine, keeping things close to your vest. So, we'll look forward to disclosures when they're appropriate. Thanks so much for being here.
Thank you.
Really appreciate you taking the time.
Thank you, David, and thank you to the investors for being here. I really appreciate it.
Excellent.
Thank you, sir.
Thanks.
Thank you.