ANI Pharmaceuticals, Inc. H.C. Wainwright 28th Annual Global Investment Conference

Thank you. Thank you, Brandon.

Sure. Good afternoon, everybody, and thank you for being here and joining us. ANI is a fast-growing, profitable biopharmaceutical company where we are accelerating our transformation into a leading rare disease company. Our rare disease business is approaching approximately 60% of our sales in 2026. We have two assets with durability and growth. Our lead asset, Purified Cortrophin Gel, is approved across multiple indications, 20 plus, of which we focus on six or seven. It is a tough drug to genericize. We have IP that goes into 2043. Most importantly, we have a significant unmet medical need, which a large addressable patient population that we are just scratching the surface on in terms of addressing. Similarly, ILUVIEN is an intravitreal implant that is made of fluocinolone acetonide. It is indicated for diabetic macular edema and chronic non-infectious uveitis affecting posterior segment of the eye.

It also operates in large addressable markets and has a multi-year growth opportunity, and there are significant barriers to genericization. Both our rare disease assets have significant growth and durability. We also have a generics business, which is high performing. It has been delivering strong growth over the past four to five years. It is on the back of strong R&D capability, operational excellence. We have three manufacturing facilities in the U.S. We have 95% of our sales coming from products that are manufactured in the U.S. We are able to invest about 10% of sales into our generics business into R&D and deliver 10 to 15 new launches that drives the success of our generics business.

Overall, we have a strong, high-performing business with two platforms, our strong rare disease business, which is where our focus is for capital allocation, and then our foundational generics business that generates EBITDA and cash flows that drives that we can reinvest into rare disease.

Sure. Great question. I think first, just to explain what Cortrophin is. It's a naturally derived product drug that is made from the pituitary glands of porcines. It's used in several autoimmune indications. It is shown to bind with, on an in vitro basis, with all five cell surface proteins called melanocortin receptors, and so it has a non-steroidal pathway. It was believed to have a non-steroidal pathway of action. It's used for alleviation of symptoms related to exacerbations that patients have with multiple autoimmune indications, such as multiple sclerosis, rheumatoid arthritis, nephrotic syndrome and many more autoimmune indications. What we find is when you look at the addressable market, it's a late-line therapy for use in these diseases where disease-modifying therapies have not worked, and that the appropriate patients are patients that have a high side effect profile to steroids or are refractory on steroids.

It's really a late-line treatment. We believe the addressable market across indications is approximately 1 million patients. And we're scratching the surface between us and the competitor in terms of the number of patients that are being served with ACTH therapy. As an example of what we mean by addressable market, if we take acute gouty arthritis flares, there are 10 million patients roughly that have acute gouty arthritis flares. Many of them have flares that resolve on their own. Then there's a number of them that take more oral treatments such as prednisone, colchicine, et cetera, and have their flares resolve. There's a small subset of patients that have, those flares are that bad that they need injectable treatments to have the flares resolve. And that 285,000 is what we consider as our addressable market. So not the 10 million, but 285,000.

If you replicate this analysis across our leading indications, then that number adds up to about 1 million patients. So going back to your question, which is beyond the quarterly cadence, what is really the driver of growth in this market is really the unmet need of these 1 million patients, that the addressable market and us, our ability to reach these patients, and service them. And serve them, sorry. Fantastic.

Sure. When we started the year, our initial guidance was on $540 million to $575 million. in Q1, we had a headwind with insurance reverifications where there was a large number of patients that needed insurance reverification, and that was exacerbated further by weather-related delays. As a result, our Q1 performance at $75 million was short of our initial expectations when we gave the guidance. Having said that, we delivered 53% quarter-on-quarter growth and delivered $117 million in Q2.

When we looked at our Q2 earnings, when you add Q1 and Q2, about $192 million, we looked at what is coming in the back half. Essentially, we found that we could basically get to where we had thought the back half would be when we give the initial guidance, but not in excess of that to make up for what we fell short of in the first half. That is why we adjusted the guidance down 5%, from $540 million to $575 million, to $520 million to $540 million.