Hey, good afternoon, everyone, and welcome again to the thirty-fifth annual Piper Sandler Healthcare Conference. This is David Amsellem again from the pharma team here at Piper, and our next company is ANI Pharmaceuticals, and we have Nikhil Lalwani here with us, CEO. Thanks so much for joining us. And, before we get into questions, I'll just turn it over to you to make some brief introductory remarks and then, lots to talk about with the business.
Sure.
We'll try to cover a lot of ground in 25 minutes, but I'll turn it over to you, and thanks again.
Yeah. Thank you, David. Thank you for having us, and welcome, everybody, and thank you for taking the time to join our session. We're ANI Pharmaceuticals. We're trying to build a sustainable biopharma company that's serving patients, improving lives. Two main growth drivers for ANI, our Rare Disease business with Purified Cortrophin Gel as the lead asset. We're in the second year of our launch, and we'll obviously tell you more as we go along. And we're building, we're increasing the scope and scale of our Rare Disease business through M&A efforts to, you know, to add an asset that can leverage the rare disease infrastructure that we have, right? And, by infrastructure, I mean, you know, a sales force that currently details into rheumatologists, nephrologists, neurologists, and also a small dedicated sales force into pulmonologists.
So that's one leverage. And the second leverage is to leverage the rest of our Rare Disease platform. We have in place, you know, market access, medical affairs, specialty pharmacy distribution, patient support, hub services, you know, a full-fledged rare disease infrastructure. So looking at assets that can leverage that platform. Part of the Rare Disease platform. The second main growth driver for us is our Generics business.
Mm-hmm.
A couple of years ago, we bought Novitium, which is a strong organic R&D engine. You know, this year, we'll continue to deliver growth on the basis of the strong R&D that we have. Our R&D engine is ranked number two in the country with Competitive Generic Therapy approvals.
Mm-hmm.
That those are, you know, approvals for generic drugs where there's less than three-
Mm-hmm
... existing generics in the market. So just a strong generics R&D engine.
Mm-hmm.
And so a combination of these two, the Rare Disease and the Generics, is positioned us well to deliver sustainable future growth. So yeah.
That's great. Great intro, and I'll start with a high-level question about just strategic priorities. So obviously, there's the Rare Disease business, but I wanted to get a sense for where you are regarding M&A and bolting on assets that could bolster your Rare Disease business. And then secondly, how large of a transaction or transactions would you contemplate?
Sure. So, as I mentioned, before, that we're looking at two priority areas. Priority one is into assets that have call points into nephrologists, neurologists, and rheumatologists-
Mm-hmm
... in the rare disease space. And priority two is call points outside of those three indications, but, you know, still leverage the rest of our rare disease infrastructure. We then have filtered it by looking at assets with peak sales, and we're calibrating the size of deal that we can do by-
Mm-hmm
... calibrating what's the peak sales forecast-
Mm-hmm
... for these assets. We've looked at assets that have patent life, at least with five to six plus years of runway on it.
Mm-hmm.
We're looking at commercial assets. You know, and then you look at all of those. You filter for deal actionability.
Mm-hmm.
We've made very good progress. We obviously did a secondary equity raise to raise funds to support this M&A, and we made very good progress. We've looked at multiple different assets, and you know, are on track to expand the scope and scale of our Rare Disease business with an M&A.
Okay, that's helpful. In terms of, you know, debt capital and just, you know, thinking about the cap structure, I mean, how high would you lever up to?
Yeah. So historically, ANI has maintained a net leverage of below three, pretty much since 2018, except in 2022, when... which was the launch year for Cortrophin Gel.
Mm-hmm.
Historically, we've also used a mix of debt and equity to fund strategic imperatives.
Mm-hmm.
For example, the acquisition of Novitium-
Mm-hmm
... we used a mix of debt and equity, and that philosophy towards, you know, net leverage and towards, using a mix of debt and equity to fund strategic imperatives will continue. I will tell you that we have strong financial strength, right? I should have covered that in our overview. We have about $193 million of cash sitting on the balance sheet as of 30th September . We had reported that we had generated about $74 million of cash from operations.
Mm-hmm.
Right? So, you know, that's a cash position that is sort of supporting, you know, and giving us firepower to go do this M&A, too.
Do you have any appetite for assets outside of the rare disease brand umbrella?
Not at this time. Our priority one and two is Rare Disease.
Mm-hmm.
Because I think that's the, that's the area that we, or business model or areas that we know how to compete in.
Mm-hmm.
Having said that, you know, we would go many more steps down the field and there comes a transaction that is a branded, you know, which has patent life, which has-
Mm-hmm.
Peak sales in the area that we're looking, the zip code of what we're looking for.
Sure.
But it's not rare. I would imagine we would consider something like that, but it would have to be in the call points that we currently go to, so rheumatology and nephrology and neurology.
Got it.
Yeah.
What about an ex-U.S. expansion? How big of a priority is that?
So not at this time.
Okay.
You know, we have some limited generic sales into ex-U.S. through partners, but, you know, our focus is entirely in the U.S. We have a significant opportunity organically and inorganically in the U.S. Of course, when we do the, rare disease M&A, if there are assets that have potential outside the U.S., we will maximize that. We have enough people around the management team that have strong ex-U.S. experience, including myself.
Mm-hmm.
-that will be able to capture those opportunities.
Okay, and then the last question about strategic priorities: What about expansion of the base Generics business via M&A? Is that something that you're prioritizing?
Capital allocation is obviously a very important discussion and decision for us. At this time, you know, we've prioritized rare disease M&A-
Mm-hmm
... as the area for primary capital allocation. And for Generics, we are funding our growth by investing in organic R&D-
Yeah
and some opportunistic tuck-in deals on the BD side, but primarily through organic R&D.
Yeah. So let's talk about ACTH.
Yeah.
I wanted to start with just an overview of the commercial infrastructure. I know you talked about the different physician specialties that you're targeting. I guess a couple of questions is, one is, you know, is the sales organization right sized? And then number two is just talk about the headcount you have that's focused on the different specialties.
Yeah
... which of these specialties, you know, take more priority over others, if that's the case?
Sure. So, we obviously try to find a balance between sharing information that is helpful to investors and information that is competitively sensitive.
Understood.
Having said that, I think what we can share is that we have a sales force of highly experienced rare disease expertise, right? Folks that have been in the rare disease area for a long period of time, multiple President's Club winners-
Mm-hmm
... and really know how to engage on rare disease products. We, our sales force, majority of our sales force is currently detailing across, in their region, across nephrology, rheumatology, and neurology.
Mm-hmm.
We launched a small dedicated pulmonology sales force-
Mm-hmm
... earlier in the year, and that's gaining momentum. But that's where we are today. Yeah.
Okay. Do you envision more expansion down the road in terms of the headcount?
Look, we'll obviously continue evaluating, you know, ROI-positive initiatives. I think if you look at our SG&A spend and how that's increased minimally over the years versus the increase in sales, you know, we saw leverage from the existing sales force. It's something that we'll keep evaluating as we go forward.
Yeah. So I wanted to ask a few questions on-
Yeah
... ACTH commercial dynamics. So first, can you talk about where your new starts are coming from? Are these patients that are, who are naive to ACTH? Are they switchers from Acthar? Is it a mix of both?
Yeah, so, we've actually in Q3 reported record new patient starts and record new cases initiated.
Mm-hmm.
The growth we saw was across all three, you know, prioritized therapeutic areas-
Mm-hmm
... which is neurology, rheumatology, and nephrology. We also saw pulmonology gaining momentum. We've also seen a continued increase in the number of repeat prescribers, and increase in the increased coverage from prescribers who were naive to ACTH therapy.
Hmm, okay.
We believe that our, you know, our efforts in increasing awareness of ACTH therapy and providing an alternative option that provides greater access to patients has played a significant role in, you know, growing the ACTH market after years of decline.
Yeah.
The category has seen quarter-on-quarter unit growth for six quarters in a row.
Mm-hmm
... ever since we launched. Even today, the number of patients that are being treated with ACTH therapy is significantly lower than were being treated, you know, many years ago.
Mm.
And, so that, you know, that, gives us significant opportunity to, you know, to serve more patients.
Yeah. So this isn't... I guess if I'm thinking about this correctly, this isn't really about you pulling patients from Acthar, but really trying to, I guess, grow the pie, so to speak. And it's not, certainly not where it was years ago, but the idea is that you've had a shrinking pie for a while. The goal is to grow it, and this isn't really a zero-sum game versus Acthar.
Yes, absolutely. We definitely-
Mm-hmm.
Our aspiration is to serve more and more patients.
Yeah.
As I said, the number of patients that are on therapy today, ACTH therapy today, are significantly lower than they were a few years ago.
Yeah.
We so see no reason why, you know, we can't get back to there and even beyond, to serve patients. Again, this is for appropriate patients' need.
Mm-hmm.
Yeah, so finding those appropriate patients.
... Okay. Where have you gotten the most traction? Is it nephrology, neurology, or immunology? And I guess, you know, putting pulmonology aside, 'cause it's pretty new. Of the three core therapeutic areas, I mean, what, which one has the biggest portion of the mix?
Yeah. Well, first, I just want to see if anyone from Mallinckrodt is in the audience. I'm just kidding. No, I think we've seen traction across all three. Yeah, it's a joke.
I'm having Acthar flashbacks, you know, and covering the-
Yeah.
-the Mallinckrodt years.
So, no, we've seen traction across all three. I think that there's an underserved patient population across all three-
Yeah
Indications, basically.
Okay. What about treatment duration and patient persistence? I know that the duration of treatment courses varies according to the therapeutic setting, but can you just talk about which settings have the longest treatment courses and therefore the most valuable?
Yeah. So, I think a couple of things. First is the dosing and frequency varies, as you noted, across-
Mm-hmm
... specialties.
Mm-hmm.
It also varies, you know, the prescribers know best what's right for the patient that's sitting in front of them.
Mm-hmm.
But if you talk about an aggregate from publicly available information, what you see is the number of vials per patient is between 6 vials-9 vials.
Mm-hmm.
It's being lower for neurology, so-
Yep
Multiple sclerosis patients and higher for the others.
Yep, okay.
Yeah.
That makes sense. What about payer dynamics? So, you know, I know for years, Mallinckrodt, you know, there was consistent headwinds regarding the payer landscape, and that was a big reason why utilization was declining. So with your product, what do payer dynamics look like? You know, and also, can you talk to pricing dynamics relative to Acthar?
Yeah. So, providing an alternative ACTH therapy, and getting that therapy to as many prescribers and appropriate patients is a sort of a core effort of ours.
Mm-hmm.
And to that end, we engage with PBMs and payers right out of the gate, or in fact, even before we launched, and have, you know, created access for patients in need, for appropriate patients in need. With regards to pricing, we launched at a discount to
Mm-hmm
... to the other ACTH therapy. Since then, they took one price increase, and then in a few months after we launched, and then for both drugs on January 1, 2023, both competitors took a 3% price increase.
Yep.
So yeah, that's the pricing dynamics as it currently stands. So today, on a WAC basis, we're still significantly lower than the competitor product.
Got it. Okay. Have you-- Can you say how much lower?
It's in the 23.5% range.
Okay.
Yeah.
So kind of standard for, you know... I'm not gonna call you a generic entrant, but a, you know, a single entrant in a -
Two NDAs, two brand products in the same-
Right
-category.
Yeah.
Yeah.
Got it. Okay, that's helpful. So I know you had the new indication, acute gouty arthritis flares, and that's with the 1 mL vial. Let's just talk about broadly how you look at the impact and that indication and that opportunity.
Yeah. So a couple of things. I think this is an indication that we have that is not an indication that the competitor has.
Right.
We believe that the 1 mL vial, right, we obviously invested to get a 1 mL vial, this new size vial size-
Mm-hmm
-because that's what's appropriate for acute gouty arthritis flares-
Mm-hmm
-which is what our product is indicated for. It's early days in the launch. You know, we'll share more as the days go by.
Sure.
But it is a launch that we are excited about, and although at this time, we're leveraging the same sales force, right? So the same sales force that's going into-
Immunology, rheumatology?
Rheumatology, correct.
Yeah.
That's right.
How do you think about that opportunity, you know, in a market that is... You know, gout is not that well served, particularly with patients with chronic repetitive flares. So, I mean, do you have a sense of, you know, what you think the sales opportunity, you know, could be, or how, what's the extent to which that can drive an acceleration and growth for the franchise?
Yeah, look, it's, again, it's early days of the launch.
Yeah.
We'll share more as, you know, as the days go by. Gout obviously is not a rare disease.
Sure.
Right? We're talking about very specific patients that have acute gouty arthritis flares.
Mm-hmm.
We'll try and dimensionalize that as we go along. We've done the exact same thing as we went with the Cortrophin Gel launch-
Got it
-across the primary indications, and we'll do the same, as the weeks and months go by.
Okay. Just taking a step back, so this—I think of the product as more essentially a brand. So with that in mind, how should we think about the impact of the ACTH product on, you know, corporate growth and operating margins over time as the footprint of the product expands?
Yeah, I think the corporate growth and operating margins will improve directionally. You know what Steve, our CFO, always says, that you know the established, the older brands that we sell have the highest gross margin.
Yep.
The generics are at the other end-
Mm-hmm.
And then Cortrophin Gel is somewhere in between.
Okay. And then can you talk about your IP runway and how do you think about potential barriers to generics?
Okay, you know, the ACTH brand drug was $1.2 billion in 2017.
Yeah.
So generics have been making a run at this for some period of time. We believe it is a very complex drug to genericize, and as to the best of our understanding, most efforts are either dwindling or stopped.
Mm-hmm.
As far as IP runway goes, you know, we are taking steps in that direction. Obviously, our drug was approved, you know, many, many decades ago.
Right.
But we are taking steps to add IP protection to our product.
Okay, but to be clear, you, you're not aware of any filers, you know, any generic ANDA filers, anything like that?
Yes, that's correct.
Got it.
Or, or even, you know, programs that are in the sort of meaningful timeframe.
Got it.
Yeah.
Okay. So let's switch gears in the few minutes we have left to the Generics business and just lay the land, how many ANDAs are in the pipeline, how many are in development? And just also walk us through your dosage form, the dosage forms that are in the pipeline and also in development.
Yeah. So I think directionally, you can think of ANI. I think historically we've launched... And when I say ANI, it's now ANI plus Novitium, the business-
Mm-hmm.
-we acquired. You know, launching between 12-20 products a year, I think will directionally go more towards 12-18-
Mm.
Type products. The relative size of the products will go bigger, as you know, as we now have a much larger, you know, Generics business.
Mm-hmm.
You have to, you know, from new products, get the growth that will offset the erosion that you see in the base products, right?
Mm-hmm.
In terms of capability, I think we do most dosage forms other than injectables and respiratory. So we do tablets, capsules, creams, gels.
Mm-hmm.
Hormonal products, controlled substances. I think we've got facility in Baudette, Minnesota that does our hormonal products. Our entire company-owned manufacturing footprint is in the U.S.-
Mm-hmm.
in East Windsor, New Jersey, and Baudette, Minnesota. We've just expanded or, or expanding, this year, we've spent about $5 million-$6 million on CapEx, expanding the New Jersey facility-
Mm-hmm.
and adding capacity there.
What's your outlook for 2024 in terms of how many ANDAs or 505(b)(2)s or both, that you're expecting to submit? And, you know, any major approvals or potential approvals next year that you're excited about?
Yeah. So I think, directionally, 12-15, 16 approvals is-
Mm.
or products that we'd consider launching. Sometimes we bring back older products where there's a market need, right?
Mm-hmm.
Where multiple people have exited. So that's something that we also do.
Mm-hmm.
But that's directionally what we would say. And in terms of, you know... Sorry, what was the second part of your question?
Sorry, any specific approval?
Oh, yeah. No, I think that, you know, we have a mix-
Entry to market opportunities.
Yeah.
Yeah.
There are products that are interesting, but not anything that's sort of outsized versus the relative size of our portfolio.
Okay.
So nothing that would necessarily expand margins markedly or-
Our new products will be at better margins-
They will be.
than the base, right.
Okay.
But-
Okay.
We don't have, you know, one or two products that are, let's say, a $100 million product or a $70 million- product-
Sure.
That's coming down the pipe. Yeah.
Got it. Okay. You've talked about shortages in the past.
Yeah.
Pretty recently, actually. So I guess if you can talk to specific products of yours that have benefited from shortages, and how could market shortages impact your business next year?
Yeah. So we've, you know, market shortages that we've talked about, come from three trends, which we believe will persist or are persisting. One, is that FDA audits at, foreign manufacturing sites, right?
Mm-hmm.
They are persisting, and the outcomes are not great, unfortunately. It's taking companies time to remediate those observations that come back, and then for the FDA-
Mm-hmm.
-to come back in and, inspect and say everything's okay.
Mm-hmm.
Second is, you know, there's obviously other generic companies that have had financial issues.
Sure.
Right? And then third is, there are product-specific issues or product-specific tailwinds that we've... So these are the three sort of market trends-
Mm.
We think, and more than just us, the larger generic players, as well as if you'd ask customers, think that this market trend will continue for some period of time.
Mm-hmm.
We've seen benefits from these, both in our Generics and established brands business.
Mm.
In 2023-
Mm-hmm.
We expect some of these tailwinds to continue, and we expect that some of these... And again, these are some opportunities come on and then they go off.
Mm-hmm.
and other opportunities come on. So at a product-specific level, the mix of products changes from time to time.
Sure.
Probably not great to share what's appropriate right now.
Sure.
Yeah.
But to be clear, though, this isn't something that's going away. This is something that should have an impact, in a good way, on your business going forward.
We believe so. I think that-
Yeah
... our ability, and this is not, you know, this is not, this is something that we prepare well for. We have a great GMP status at all our manufacturing sites.
Mm-hmm.
We maintain adequate finished goods and API inventory levels.
Mm-hmm.
-to ensure that we can service, and then we move fast, right? When a customer has a shortage, we are able to move fast and meet the additional demand, and we've been able to do so successfully, and therefore, we're counted on as a reliable supplier. And so when these sorts of issues come up, or even if there are regular jumbos that come up-
Mm.
They, you know, the customers, we're a preferred partner of theirs.
Right. And to be-
We work hard to retain that reputation.
And to be clear, you have sufficient capacity to be able to-
Correct.
-to handle shortages.
Absolutely.
Okay.
As I told you, we've enhanced our capacity at the New Jersey site to even take on more.
Great.
Yeah.
Okay. Well, looks like we're out of time, but thank you, Nikhil, and thank you in the audience.
Yeah. Thank you, Dave.
Okay.
I appreciate it. Thank you.