Get going here with our next session. Thank you everyone again for joining us for the Guggenheim Biotech Conference this year and for day two. Next up in this room, we have ANI Pharmaceuticals. I'm Vamil Divan, by the way, if you don't know me, one of the pharma analysts—biopharma analysts here. Joined up here by Nikhil Lalwani, who's the President and CEO of ANI Pharma. Thanks so much for joining us today. We're gonna do a fireside chat format, so I have some questions I'm gonna go through. If anyone in the audience wants to ask a question, please feel, raise your hand, and we can get your question in as well.
But, maybe just, especially for people who may be a little bit newer to the story around ANI Pharma, obviously, been a pretty exciting time these last couple years here. If you can just sort of give an overview of the company, the key sort of business segments that you're focused on and some of the key metrics in terms of recent performance. I know you haven't reported fourth quarter yet, but just at least through the third quarter of 2023.
Sure. Thank you, Vamil, and, you know, great to be here, and thank you all for taking the time to join this session at the Guggenheim Biotechnology Conference. Yeah, so ANI, we're building a high-growth biopharmaceutical company that's focused on serving patients, improving lives. Our rare disease business will be the largest driver of we forecast will be the largest driver of ANI's growth. We launched our lead rare disease asset, Purified Cortrophin Gel, in January of 2022, and issued guidance in Q3 2023, that we would do $100 miilion-$107 million in 2023 sales, which represents about 140%-157% growth over the prior year.
For those that are new to Purified Cortrophin Gel, it is a therapeutic that is used to treat certain autoimmune indication- exacerbations of certain autoimmune indications, such as multiple sclerosis and rheumatoid arthritis, and also, in some situations, also for nephrotic syndrome. It is used for, you know, for patients that are or may be appropriate as an alternate treatment option for patients that are refractory to corticosteroids. So that's our rare disease business and our lead asset.
We also plan to expand the scope and scale of our rare disease business through M&A in 2024, adding an asset or assets that will leverage either our sales force, with call point synergy or the rest of our well-established now rare disease platform, with specialty pharmacy distribution, market access, medical affairs, patient support, you know, medical and the entire back, backbone of the rare disease platform. And then our legacy businesses and generics and established brands continue to generate strong cash flow for us on the back of fueled by a high-performing generics R&D engine and innovative commercial initiatives. And then from a numbers perspective, the guidance we gave in at the Q3 earnings was revenues of $468 million-$478 million, about 50% revenue growth over the prior year.
Adjusted non-GAAP EBITDA of $128 million-$133 million, which is about 129%+ growth over the prior year. And then the adjusted non-GAAP EPS of $4.29-$4.57, which is 200%+ growth over the prior year. So that's a bit of an overview of ANI. I'm happy to talk more.
Yeah. Okay, so let's dig a little deeper into Cortrophin, as you mentioned, the-
Yep.
Surprise, where we were both excited and one of the main sort of growth drivers going forward. So just can you... You mentioned the $100-$107 million guidance for 2023. It's almost the second full year on the market. Where are the key areas that you've seen the progress and the uptake sort of to date? You know, kind of what would you highlight in terms of launch and what, what's gone well there?
Sure. Yeah, you know, we've seen growth across existing prescribers as well as new prescribers in our core sort of therapeutic-targeted specialties, right, of neurology, nephrology, and rheumatology. We saw a record number of new patient starts in the third quarter of 2023. We've also, you know, done a small launch into pulmonology with a dedicated sales force, and that has. We've seen strong physician response on that. So that has also been a good area of growth for us. And then in the fall of 2023, we launched and made commercially available a 1 mL vial for the treatment of acute gouty arthritis flares.
And, you know, it's early days into that launch, so there are multiple different growth factors, as you will see, for Cortrophin Gel that we are excited about. And when you think of the ACTH market as a whole, right, this was a market that was declining for the last few years. But since ANI has launched, and the efforts that we have made to increase awareness of Cortrophin and ACTH therapy have yielded results. For six quarters in a row, there has been unit growth quarter-on-quarter, year-on-year, according to IQVIA data, right? And, you know, if you think of where we are today, the number of patients being treated on with ACTH therapy is significantly lower than the number of patients being treated with ACTH therapy a few years ago.
I think that that gives us a significant opportunity to, to serve, of course, the appropriate patients. Yeah.
Yes, I want to touch on that a little bit. So obviously, there's one main competitor that you're dealing with-
Yep
... in this market. You mentioned the market seems to have recovered from what it was going through before. So where do you see the growth coming from, sort of going forward? Is it more... Is it specific therapeutic areas, specific indications, where you think the growth is gonna come from? Is it more expanding the market, getting new prescribers to write, or maybe just getting ones who wrote it before, to rewrite now, you know, after maybe-
Yeah.
Taking some time off? How do you see the market evolving?
Yeah. Yes, I think, you know, we are in a fortunate position where there is growth opportunities across each of the areas that you spoke about. We definitely see that there are prescribers that wrote ACTH therapy before, that have reduced the amount they were writing or had stopped, and there continues to be an opportunity, additional opportunity with sort of reengaging them and, you know, adding that therapeutic for appropriate patients, in their, you know, treatment paradigms. We also have had success, you know, bringing ACTH therapy to prescribers who are naive, who have been naive to ACTH therapy.
And then, you know, going back to your question on targeted specialties, look, there's opportunity across all the three targeted specialties of neurology, nephrology, and rheumatology, as well as, in the area that we started, you know, a small, dedicated sales force with, which is in pulmonology. And then when we think of, you know, what are we trying to achieve overall? We're trying to bring ACTH therapy to as many appropriate patients, and, you know, we see that this is not a share capture game versus the one competitor, but really about, you know, growing the number of patients that can benefit from this therapy. And knowing that, you know, a few years ago, the number of patients that were benefiting from this therapy was significantly higher than where we are today.
Okay, so then, a couple of follow-up questions, and these are things we get often from investors. So you still, you've had, you know, good success, over $100 million in, you know, in your second year, but still relatively minor share compared to the competitor. Based on what you're seeing in the market, based on the uptake you're having, is there any reason why you shouldn't be able to at least sort of split the market with the competitor? Is there, do we think that you may be able to get more than that? And again, we've seen this market be over a billion-dollar market, you know, back several years ago.
Is there any reason to think that this, we shouldn't get back to at least close to that level, whether it's from a, you know, physician side, payer side, anything that you'd sort of point to? Because I think our estimates are over $300 million dollar peak sales. I know you guys haven't given guidance, but it feels like there's a lot of room to potentially go here.
Yeah. No, look, we agree with the fact that there is significant room for growth, and the way we've characterized it prior is that we are in early days of our launch. We obviously try to strike the balance between sharing information that is helpful to investors as well as competitively sensitive. And so, you know, what I can say is that, you know, from what we've seen for appropriate patients, there is really, you know, no reason why this therapy can't, you know, help-ACTH therapy can't help, sort of, cannot help the appropriate patients in need, right? And the number today is significantly lower than what it was four years ago. Yeah.
Okay. Maybe shifting gears then. You mentioned, you know, one of your main priorities is building this rare disease business-
Yep.
You know, Cortrophin being sort of the lead asset here. So maybe you can just talk a little bit about kinda how you're, you know, looking at the landscape, what sorts of assets might be of interest, whether it's size or therapeutic area?
Yeah. Yeah, thank you. So our priority one is to add a rare disease asset or assets that leverage our existing sales force. Our existing sales force details into, you know, the specialties of rheumatology, neurology, and nephrology. So an asset that, and also a small, dedicated sales force into pulmonology. So an asset that or assets that can be, you know, beneficial in these specialties. Priority two is to add assets, rare disease assets, that leverage the rest of our rare disease platform, such as, you know, our patient support, hub services, medical affairs, specialty pharmacy distribution, market access, you know, so the rest of our infrastructure.
We've applied several parameters as we've been looking, and we've made good progress as we've been looking for M&A targets. The first parameter is, you know, we do wanna add a commercial asset or an asset that's very close to commercialization. At this point, we do not want clinical risk. So that's one. Second is, having, you know, enough IP runway, right? So, a protected asset that has, you know, at least 7+ years of IP runway. And then from a, you know, from a revenue peak sales perspective, assets that will be meaningful additions to the scope and scale of our rare disease business, and you already know, you know, we've spoken about our lead asset, Cortrophin Gel, and the scope and scale there, right?
We wanna add assets that are meaningful. Then finally, right, it's all great to do this exercise, but if it's not actionable, that's not very helpful. Yeah, we're making good progress, but this is how we're thinking about, you know, the M&A in 2024 for our rare disease business.
Okay. Again, just in terms of, you mentioned a couple times, so it is this year that we should expect at least one announcement?
Yeah. Look, I think, from-
Assuming you find out-
Yeah, exactly. So I think organically, that we have significant headroom for growth. So ANI is under no pressure to do an M&A, right? We are, you know, we have significant headroom for growth across business lines. So we wanna do the right deal, not just a deal. However, having said that, yes, we, with the progress we've made, we could see ourselves getting a deal done in 2024.
Okay. And how are you thinking about in terms of, you mentioned a little bit around the size and scale, in terms of funding the, the deal? I know you guys did a raise last year, or maybe you could talk about, you know, equity, cash, debt. How are you thinking about financing?
Sure. Yeah, so ANI's balance sheet is strong. You know, based on the guidance we gave in Q3 of 2023, you can assume that we'll have more than $200 million + of cash on the balance sheet. With the strong performance in EBITDA over 2023, we've de-levered and are at a net leverage of less than one. And I think that both of these sort of gives us significant flexibility in terms of our ability to fund an acquisition that is, you know, meaningful to adding scope and scale to our rare disease business, without straining our balance sheet. The only other thing I would add is that...
Yeah, so sorry, on the cash, cash flows, we did do the $80 million net proceeds from the equity raise last year, but we also generated over $100 million of cash based on guidance-
Mm-hmm
... in 2023. Right? So that gives us, again, that gives us confidence that we, you know, our overall business is generating a healthy amount of cash to continue to fuel our aspiration, and that obviously keeps building quarter on quarter. And then the last thing to add is, you know, in the past, ANI has used a mix of debt and equity for the right acquisition. So if there is a need, I think that is something we may use. Again, you know, we wanna, again, do the right acquisition for ANI that builds the scope and scale of our rare disease business, and enhances the high growth transformational journey that we're on.
Okay, that's good. Maybe one, just going back to Cortrophin before we move on to the other segments. You mentioned the 1 mL vial-
Yes
... that you launched recently. Just could you kind of, focus on that launch, you know, that offering and any highlights on, you know, the progress you've had with that launch so far?
Yeah. So I, it's early days on that launch. We've launched the 1 mL vial specifically from a dosing perspective. It is appropriate for acute gouty arthritis flares, which is an indication that we have that the competitor does not have. And I think what we can talk about at this point is that we do have a unique J code, and that also enables the administration by the physicians and supports that for the 1 mL vial. The 5 mL vial is largely used on a self-administered basis. Again, we've gotten strong, you know, favorable physician response for use of Cortrophin for acute gouty arthritis flares.
But in terms of dimensionalizing it and the scope and scale of the opportunity, I think it's early days for us, and we'll come back and share more. But, you know, we are glad that we took the step to, you know, to bring the 1 mL, a new presentation of Cortrophin Gel to the market, for acute gouty arthritis flares. Yeah.
Okay. So maybe now let's shift to the other two segments. So first, generics.
Yeah.
Maybe you can just sort of give an update on kind of the progress you've made there, obviously, the Novitium acquisition.
Yeah.
And just the outlook, what's gonna drive... How should we think about the growth there? I think that's a market, at least for us and a lot of people. It's a little bit tougher to sort of-
Yeah
- predict how things are gonna play out.
Yeah. Yeah, look, it's a legacy business of ANI. The generics business is one that we grew through BD for the most part. When I joined as CEO three and a half years ago, we made an acquisition of Novitium to add an organic or to add, you know, our own R&D team and engine. That team is continuing to deliver, and based on sort of superior R&D execution, as well as which results in new product launches for our generics business, as well as strong overall operational execution, which is key to success in the generics business. We see ourselves in high single digits, low double digits type growth for the generics franchise.
Okay, and then established brands, I think, that had, you know, very strong performance so far in 2023. Similar questions on how to, how to think about that, maybe more-
Yeah
... from a strategic perspective and then from an outlook perspective.
Yeah, I think established brands, the new assets will come through opportunistic BD, and we continue to look for those. But the scope and scale of those is, you know, dramatically different from what we're talking about for rare disease. And again, from a capital allocation perspective, we should be clear that rare disease is the primary focus area for ANI at this time, and expanding scope and scale of the rare disease business. So you know, at established brands, we've continued to deploy unique and innovative commercial initiatives to expand that franchise, but more to come on that, yeah.
Okay. And then in terms of R&D, I guess, how do you think about it, maybe again, strategically, you have three very sort of different businesses, in terms of the way the spend is going now-
Yeah
... how we should think about future?
Yeah, sure. So I think two main areas. One is generics growth, right? If you think about our generics business, all we're doing there is fueling the R&D. That's the giving new product launches for the generics business. And then the second area is initiatives for our rare disease franchise. So at that, at this point, you know, things that we may be looking at for Cortrophin, for things beyond Cortrophin. So I think, you know, early days on that, but, you know, looking at largely on stuff for Cortrophin, R&D spend, whether it's lifecycle management, whether it's other things for Cortrophin. Yeah.
Okay. All right, I know you guys just, I think, this week announced you'll be reporting your fourth quarter at the end of the month, and obviously getting guidance and all that with that. But maybe recognizing that's still to come, just a sense of how we should think about the outlook for ANI overall for the next year, next 3-5 years. What, what's your-
Yeah.
-vision?
Yeah, look, you know, overall, ANI is well-positioned to be a high-performing, sorry, high-growth biopharmaceutical company with rare disease as the, you know, as the, we believe, as the largest driver of absolute ANI growth. We will be happy to share further progress on February twenty-ninth at 8:30 A.M. at our earnings call on, you know, further update from Q3. But look, you know, rare disease with our lead asset, Purified Cortrophin Gel, as well as expanding the scope and scale through rare disease M&A, will be the largest driver of ANI's growth. We believe, and we'll be happy to share more at the earnings. Yeah.
Okay. Maybe one other question we get from investors, I think, because there are sort of three different businesses here, all having their own, you know, positive drivers. Again, looking longer term, is there value and synergies to having these all under one umbrella? How do you think about that?
Yeah.
-in rare diseases? Sort of the focus of how do the generics and established brands fit in three, four, or five years from now?
Yeah. Yeah, look, this is a good question, and, you know, and one that we, we keep thinking about. At this point, you know, from a capital allocation perspective, we're clear that the, the large spend will be on rare disease M&A and will continue to fuel the growth of our rare disease business. At some point in the future, there, it may make sense to, you know, to not have both these on the same platform. But it's, again, it's very early days, for that type of a discussion. Yeah.
Okay. Okay, why don't we, in the interest of time, let's, leave it there. I know you have some more meetings. Thanks so much again for joining us at the conference, and look forward to following the progress.
Yeah. Thank you, Vamil.
Yeah.
Thank you, everybody.