Good day, everyone, and welcome to today's ANI Pharmaceuticals Inc Third Quarter 2024 Earnings Results Call. Please note that this call is being recorded. After the speakers' opening remarks, there will be a question-and-answer session. [Operator Instructions] It is now my pleasure to turn the conference over to Lisa Wilson. Please go ahead.

Thank you, Todd. Welcome to ANI Pharmaceuticals Q3 2024 earnings results call. This is Lisa Wilson, Investor Relations for ANI. With me on today's call are Nikhil Lalwani, President and Chief Executive Officer; Steve Carey, Chief Financial Officer; and Chris Mutz, Senior Vice President and Head of ANI's Rare Disease business. You can also access the webcast of this call through the Investors section of the ANI website at anipharmaceuticals.com. Before we get started, I would like to remind everyone that any statements made on today's conference call that express a belief, expectation, projection, forecast, anticipation, or intent regarding future events and the company's future performance may be considered forward-looking statements as defined by the Private Securities Litigation Reform Act. These forward-looking statements are based on information available to ANI Pharmaceuticals management as of today and involve risks and uncertainties, including in those noted in our press release issued this morning and our filings with the SEC. Such forward-looking statements are not guarantees of future performance. Actual results may differ materially from those projected in the forward-looking statements. ANI specifically disclaims any intent or obligation to update these forward-looking statements except as required by law. The archived webcast will be available for 30 days on our website, anipharmaceuticals.com. For the benefit of those who may be listening to the replay or archived webcast, this call was held or recorded on November 8th, 2024. Since then ANI may have made announcements related to the topic discussed, so please reference the company's most recent press releases and SEC filings. And with that, I'll turn the call over to Nikhil Lalwani.

Thank you, Lisa. Good morning, everyone, and thank you for joining us. Today, I'll start by discussing our third-quarter performance and highlights. You'll then hear from Chris Mutz, ANI's Head of Rare Disease. After Chris provides additional color on the progress of this segment of our business, including the integration of Alimera, Steve will review the quarter and our updated guidance in more detail. Following our remarks, we'll take your questions. It's an exciting time here at ANI. And we're continuing to execute well this year against our purpose of serving patients, improving lives. In addition, our team delivered record performance during the quarter. For our lead rare disease asset, Cortrophin Gel and our generics business. We also put a new, more efficient and effective capital structure in place and completed the acquisition of Alimera on September 16. As you've heard me outline previously, Alimera is highly synergistic to our Rare Disease business. And we believe our proven commercial execution capabilities can further unlock the potential for ILUVIEN and YUTIQ to growing and durable assets, as well as accelerate the growth of Cortrophin Gel in ophthalmology. Integration remains one of our key priority areas, and I'm pleased with our progress to date. In particular, we have a 45-person combined ophthalmology sales force who have been cross-trained and promoting all three products since mid-October. In addition, we have successfully retained talented Alimera employees and taken actions to ensure we are on track to capture over 10 -- capture $10 million of synergies in 2025. The Alimera acquisition is transformative for our Rare Disease business. We expect the transaction to create substantial shareholder value driving $35 million to $38 million in adjusted non-GAAP EBITDA in 2025, inclusive of the approximately $10 million of identified cost synergies and high single-digit to low double-digit…

Thank you, Nikhil, and good morning, everyone. I'm looking forward to telling you a bit more about the exciting things happening in our Rare Disease business. First, Cortrophin. We are pleased with the strong demand trends for Cortrophin Gel during the third quarter, which included continued momentum in adding new prescribers and robust growth of existing prescribers. Importantly, we saw demand growth across all targeted specialties of neurology, rheumatology, nephrology, pulmonology, and ophthalmology. Our ophthalmology sales team in particular drove significant growth in prescriptions and new patient starts in the third quarter, further reinforcing our confidence in the potential of the expanded team, which is now bolstered by the addition of the former Alimera reps and new reps we hired to complete the 45-person integrated ophthalmology sales force. As Nikhil mentioned, we believe Cortrophin Gel remains on a strong multi-year growth trajectory and the company has been taking important steps to further strengthen the Cortrophin Gel franchise. Over the past 18 months, we've launched dedicated sales teams in pulmonology and ophthalmology, and with the Alimera acquisition, we now have an expanded sales team in ophthalmology. Moving now to our efforts toward improving patient and physician experience and convenience. We are pleased to announce that we've completed the development of a pre-filled syringe offering for Cortrophin Gel and submitted a supplemental NDA for FDA approval in late October. We believe the pre-filled syringe will provide further benefits to patients and physicians by reducing the steps needed for self-administration and are excited about the potential for this new offering that we plan to launch in the first half of 2025. We are also exploring other ideas to enhance the convenience for patients starting on Cortrophin Gel and the healthcare providers who treat them. And as a reminder, in the fourth quarter of…

Thanks, Chris, and good morning to everyone on the call. I'll review our third-quarter results and then discuss our updated 2024 guidance. ANI generated third-quarter revenues of $148.3 million, up 13% over the prior year period. Revenues from Cortrophin Gel reported in our Rare Disease segment were $52.6 million, up 77% from the prior year period, driven primarily by increased volume on a record number of new patient starts. Based upon the continued strong execution of the rare disease team in driving growth, we are raising our full-year Cortrophin Gel revenue guidance to $196 million to $200 million. The acquisition of Alimera closed on September 16th and therefore, our third-quarter financial statements reflect approximately two weeks of revenue and expense activity. We are reporting combined revenues from these products under the heading, ILUVIEN and YUTIQ, which contributed $3.9 million of revenues to our rare disease segment during the two-week period. Revenues for our Generics, established brands, and other segment were $91.9 million, a decrease of 10% over the prior year period. Generic revenues for the quarter were $78.2 million, an increase of 11% over the prior year period, driven by increased volumes on contributions from new product launches in 2024 and the full-year impact of products launched in 2023. Net revenues for established brands and other were $13.7 million in the quarter, a decrease of 57% over the prior year, which was in line with our expectations. Starting today, when I speak to our operating expenses for purpose of this earnings call, I will be referring to our non-GAAP expenses, which are detailed on Table 3 in our press release. Generally, our non-GAAP operating expense excludes depreciation and amortization, stock-based compensation and certain costs related to litigation and M&A activity. Please refer to Table 3 for a reconciliation to our…

Thank you, Steve. The continued strong performance of our business in the third quarter underscores the strength of our strategy and highlights our solid execution. And we're excited about the potential of the new expanded Rare Disease business. We now have multiple growing and durable commercial rare disease assets and an augmented sales team covering the specialties of ophthalmology, neurology, nephrology, rheumatology, and pulmonology. We look forward to seeing many of you in person later this month at Guggenheim's Inaugural Healthcare Innovation Conference in Boston, and the Jefferies London Healthcare Conference. Thank you all for joining us today. Operator, please open the line for questions.

The floor is now open for your questions. [Operator Instructions] Our first question will come from David Amsellem with Piper Sandler. Please go ahead.

Thanks. So, I have a couple of questions. First, can you talk about the payer landscape for Cortrophin Gel and how that has evolved, if it has evolved at all? And how that looks compared to Acthar Gel? So that's number one. Number two is, you've talked about the ACTH market returning to growth. But I'm wondering out loud how much of your business is coming from practitioners who are moving away from Acthar Gel versus practitioners who are just new to the category. So can you help us understand the mix there for your product? And then lastly, on the generics business, you've had a steady cadence of new launches. I guess my question here is, what does that mean for '25? How are you thinking about the pace of new launches and the extent to which you can continue to grow your generics business moving forward? Thank you.

Good morning, David, and thank you for your questions. I'll try to take them one by one. So the first question on the payer landscape in -- for Cortrophin and the ACTH category. Look, we try to find a balance between sharing information that is relevant for investors and not revealing competitively sensitive information. So we maintain strong relationship with our partners in the market access space and believe that there is recognition of the value that Cortrophin brings to this class. And as you think about the payer landscape, I think the most important mark -- impactful market access change next year will be the increased affordability for seniors through the Medicare out-of-pocket cap along with the smoothing mechanisms for that out-of-pocket. And our patient support team is prepared to educate patients and physicians about these new options, which we believe should improve patient access. When -- your second question regarding our growth and where does it come from existing prescribers or new prescribers? I think the way I would look at it is when you look at total growth of ANI, we've been in the market for three years now. And have achieved the growth that we have, right, most recently growing from $112 million in 2023 to a guidance of $196 million to $200 million in 2024. That growth has come from both overall market growth, as well as share growth. And so when you sort of bring that down to the prescriber level, we're seeing both. We're seeing growth with share with prescribers that used to use the competitive product, as well as new prescribers that have been unique to PC to Cortrophin Gel. And the other thing to just highlight is, there are indications that ANI has that the competitor does not have, including acute gouty arthritis flares. So as you think about the overall ACTH market, which if you take our guidance and the competitor's guidance implies more than 20% growth year-on-year. And what the potential is and why we believe Cortrophin has a strong multi-year growth trajectory, there's also beyond just the existing or the number of patients that were there on therapy a few years ago, but also the additional indications that we have that the competitor does not have. So that's on the second question on the drivers of our growth in Cortrophin. And then on your third question on the cadence of new launches for generics and what does that imply for the trajectory for our generics business. We -- our strong R&D team, along with the operational excellence and our US-based manufacturing footprint with a strong FDA compliance track record will continue to deliver a cadence of new launches and we believe that the combination of these different factors will enable the ANI generics business to grow in the high-single-digits, low double-digit range going forward as we have delivered over the past few years. Thank you, David.

Thank you.

Thank you. Our next question will come from Gary Nachman with Raymond James. Please go ahead.

Thanks. Good morning. So for ILUVIEN and YUTIQ, the guidance of $30 million to $32 million is from the close of Alimera on September 16. So if I back out $4 million in the third quarter, it's $26 million to $28 million for the fourth quarter. Is that a reasonable quarterly run rate to think about going into next year? And then just talk about with the integration in place, how you plan to accelerate those products and if we could see growth next year. And also how much you think the NEW DAY data could help potentially if it's positive, I guess, in terms of combination use.

Great. Good morning, Gary, and thank you for your questions. Yeah. So your first question on ILUVIEN and YUTIQ and the Q4 implied guidance. Look, since the deal closing, the commercial organization has been in a period of transition. We've hired and now have in place 45 ophthalmology dedicated sales reps across the country. Some representatives have seen realignment of their territories. In addition, we've invested the time to cross-train this team across all three products; ILUVIEN, YUTIQ and Cortrophin. And post-training, the combined sales team has been in -- has been promoting all three products since mid-October. So the Q4 guidance reflects this period of transition. And we are confident that the underlying demand for ILUVIEN and YUTIQ are aligned with our expectations and expect to achieve our growth goals for these assets. So you -- we would expect growth over this run rate in 2025 and we remain confident that the Alimera acquisition to add incremental $35 million to $38 million in incremental EBITDA in 2025 and anticipate it to drive high single-digit to low double-digit accretion in adjusted non-GAAP EPS. And then on the NEW DAY study, I'll turn that over to Chris to answer your question regarding the impact of the NEW DAY study. I will just say that from our perspective, the double-digit growth that we've -- or the growth expectations that we have for ILUVIEN and YUTIQ have not hinged and neither did our deal model hinge on a positive readout of the NEW DAY study. Having said that, we look forward to updating you regarding as we get the top-line results towards the end of quarter one and beginning of quarter two, the implications of that on the commercial -- the commercial implications of that on the growth trajectory for ILUVIEN. But Chris, would you like to add anything?

Yeah. So as mentioned previously, the NEW DAY clinical trial is designed to generate prospective data evaluating ILUVIEN as baseline therapy in the treatment of DME and really compare it to current standard of care with anti-VEGF injections. We think this study really has a significant opportunity for people to revisit how they're taking care of DME patients. Certainly, anti-VEGF therapy has been the standard of care in early DME and patients generally receive multiple anti-VEGF treatments before physicians consider ILUVIEN for those patients. And I think from the feedback we've been getting from the retina community is that this is going to be the data that has been needed really to reconsider the way that has -- the approach that has been taken in taking care of these patients and really that the combination therapy of ILUVIEN plus an anti-VEGF could potentially have a role based on this data.

Okay.

Thank you, Gary.

And then just -- yeah. No. And then just on Cortrophin, I know it's pretty early days, but are you seeing a real benefit yet within ophthalmology from the combined sales team with Alimera, what sort of impact do you expect in the coming year, specifically in ophthalmology? And then just with the pre-filled syringe available, I think you said in the first half of next year, how much of a benefit you think that'll be from a convenience standpoint to help Cortrophin overall? Thanks.

Yes. Well, thank you for both those questions again, Gary. Regarding the pre-filled -- so I'll take your second question first, which is the pre-filled syringe. This is a new offering that we're bringing to the market for patients to make it easier for patients that have -- to increase the patient convenience versus when using the vial to make it -- make the easier from an administration standpoint to use our pre-filled syringe. So we do believe that this will be helpful for patients. This new offering will have an impact for patients that have, increased their convenience while using the -- while administering the vials. So I think that's the first -- so, I guess that was your second question. And then regarding your question on the impact of PCG in ophthalmology, look, it's early days, right? We just said that the combined ophthalmology sales team is in the market since mid-October promoting all three products. And the early signs are positive and we remain confident that there will be growth of Cortrophin in ophthalmology with this combined sales force and what the early signs are promising. But again, it's been a few weeks and we look forward to sharing further updates as we guide towards 2025 and inform on the updates on the progress made in this part of the business. Thank you, Gary.

Okay. Great. Thank you. Yeah. Thank you.

Thank you. Our next question will come from Vamil Divan with Guggenheim Securities. Please go ahead.

Great. Thanks for taking my questions. So two if I could. So one, a little bit of a different angle on the Cortrophin questions are asked before. You've continued to sort of beat and raise on this product through the course of this year. Can you maybe just talk about what parts are doing better? Is it more from a certain segments? Is it volume? Is it price or what's been driving the upside over the course of 2024, just as we again sort of think about how to model it out for next year? And then the second question, I want to make sure I caught something you said in your prepared remarks correctly. And there's something around rare disease being the biggest segment or biggest unit in 2025? If you can just clarify that that's what you said. And then when you're comparing that, are you comparing that to just generics on its own, or are you comparing it to generics, established brands, and other altogether as a segment? Thank you.

Yeah. Good morning, Vamil, and thank you for your question. Regarding growth in Cortrophin, I think first you asked whether it's volume versus price? It's a majority of the growth, almost all of the growth comes from growth in volumes. And where does that growth in volumes come from? We see growth across therapeutic areas, both the ones we focused on at launch; neurology, nephrology, and rheumatology, as well as the newer areas of ophthalmology, gout, and pulmonology. And we also see robust prescribing demand across both existing prescribers and new prescribers, as I had answered in the question for David upfront. So that's where the -- we're seeing growth sort of pretty much across the board. And then the second -- your clarification on rare disease, we're seeing the rare disease as the largest driver of growth for ANI as a company going forward. So that clarifies that part of the question. Thank you, Vamil.

Okay. All right. Thank you.

[Operator Instructions] Our next question comes from Les Sulewski with Truist Securities. Please go ahead.

Hey, this is Jeevan (ph) on for Les. Thanks for taking our questions. So as you look back on the recent Alimera acquisition and potentially consider future M&A, I'm just curious what learnings you take away from the transaction, if any, to prevent similar situations in regards to timely closure in the future. Thank you.

Yeah. Good morning, Jeevan, and thank you for your question. Yeah, I think that's just a great question regarding learnings. I think that as we look to look to pursue other M&A activities, I think we kind of remain focused on what is strategically aligned and important for ANI. So the Alimera acquisition is a highly synergistic acquisition. It helps continue to expand the scope and scale of our rare disease business, which is right in line with what we had been saying from day one, actually, for almost over a year. And that's something that we have been pursuing. So sort of sticking to our strategy, that's one lesson that we want to continue gathering forward. And then the second is, as you do an acquisition, there are bumps along the way and to make sure that we can continue to stay and work through the challenges. And what -- and those challenges may vary from acquisition to acquisition. And to ensure that we understand the challenge, that we have the capability, experience, and expertise to address the challenge and to move forward from there. And we believe that with the Alimera acquisition, there is a challenge related to the supply of YUTIQ that has come up and we are well-positioned to address that challenge, right, by what we have been working closely with EyePoint since the deal signing to address the issues on the warning letter, and that the work with and the collaboration and engagement with EyePoint has become even closer since we closed the deal. And we remain confident that there will be -- that EyePoint will satisfactory address the points raised by the FDA. In fact, they've been giving updates on the same as they've gone along. And we anticipate no impact on continuity of YUTIQ supply to patients in need. And look, it is standard practice for ANI to work towards creating redundancies in supply chain for high-value products. Accordingly, we are taking steps to increase supply security for both ILUVIEN and YUTIQ. So going back to your question, Jeevan, there will be bumps along the way as we do acquisitions and make sure that the experience and expertise that we have, we bring that to bear. In this case, it was related to supply. It may be something else in a future acquisition. And look, we have significant capability and expertise in this area, given the three plants we run in the U.S. with strong FDA compliance track records and our experience in addressing points like these jointly with our suppliers. So those are the lessons that I would stick into our strategy and making sure that when bumps come along the way that we understand the bumps and address them. Thank you, Jeevan.

Great. Thank you.

Thank you. At this time, I show no further questions in queue. I will turn the call back to Nikhil Lalwani for closing remarks.

Yeah. Thank you, everybody, for joining our call, and thank you for your interest in ANI. We look forward to continue updating you on our progress. And look forward to seeing you at the conferences that we have coming up and engaging with you as we move forward. Thank you.

Thank you. This does conclude the ANI Pharmaceuticals, Inc third quarter 2024 earnings results call. You may disconnect your line at this time, and have a wonderful day.