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M&A Announcement

Jun 24, 2024

Operator

Good day and welcome to the ANI Pharmaceuticals Conference to discuss acquisition of Alimera Sciences. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question-and-answer session. You may register to ask a question at any time by pressing Star 1 on your telephone keypad. You may remove yourself by pressing Star 2. Please note today's call will be recorded, and I'll be standing by if you should need any assistance. It is now my pleasure to turn the call over to Lisa Wilson. Please go ahead.

Lisa Wilson
Head of Investor Relations, ANI Pharmaceuticals

Thank you, Todd. This is Lisa Wilson of In-Site Communications, investor relations for ANI. With me on today's call are Nikhil Lalwani, President and Chief Executive Officer, Chris Mutz, Head of Rare Disease, and Steve Carey, Chief Financial Officer. 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 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 and recorded on June 24, 2024. Since then, ANI may have made announcements related to the topics discussed, so please reference the company's most recent press releases and SEC filings. With that, I'll turn the call over to Nikhil Lalwani.

Nikhil Lalwani
President and CEO, ANI Pharmaceuticals

Thank you, Lisa.

Lisa Wilson
Head of Investor Relations, ANI Pharmaceuticals

Nikhil?

Nikhil Lalwani
President and CEO, ANI Pharmaceuticals

Yes. Thank you, Lisa. Could we move to slide 4, please? Lisa?

Lisa Wilson
Head of Investor Relations, ANI Pharmaceuticals

You're on slide four.

Nikhil Lalwani
President and CEO, ANI Pharmaceuticals

Okay. Thank you. Thank you, Lisa, and good morning, everyone. Thank you for joining our call today to discuss ANI's proposed acquisition of Alimera Sciences, Inc. I'm delighted to share with you details of this important transaction for the company, both strategically and financially, and one that we believe will meaningfully expand the scope and scale of our rare disease business by adding two durable commercial assets with significant growth potential in a key strategic therapeutic area of ophthalmology. Next slide, please. Starting with the agenda of topics we'll cover today, first, I'll provide an overview of the transaction and the strategic rationale for our acquisition. Our head of rare disease, Chris Mutz, will then discuss Alimera's products and commercial opportunity in more detail. Stephen Carey, our Chief Financial Officer, will lay out the financial overview and details of the transaction and will close it out with a Q&A.

I'll begin first with an overview of the transaction and the strategic rationale for our acquisition. We move to slide 7, please. With approximately 160 global employees, Alimera Sciences' mission is to improve the retinal health of patients through the long-term treatment of chronic diseases. The company has two commercial assets. ILUVIEN is used to treat diabetic macular edema, or DME, the leading cause of vision loss in diabetic patients. YUTIQ is used to treat chronic non-infectious uveitis affecting the back of the eye. Both products have a unique mechanism of action and are the only long-term durable therapies available that can reduce disease recurrence to extended disease control. Alimera has been driving double-digit growth for ILUVIEN and YUTIQ and has shared 2024 revenue guidance of $105 million.

The company has a commercial presence across 21 countries and an active clinical development program with readouts expected in 2024 and 2025 that could help drive broader utilization of ILUVIEN and YUTIQ. ANI has agreed to acquire all outstanding shares of Alimera for $5.50 per share in cash, plus up to $0.50 per share in potential CVR payments based on the achievement of certain net revenue targets in 2026 and 2027. The transaction values Alimera at approximately $381 million in upfront consideration. The acquisition will be funded using a combination of cash on hand and incremental debt. ANI has obtained $280 million of committed financing from J.P. Morgan and Blackstone, which will be completed within the bounds of our existing credit agreement. We expect the transaction to close in late Q3 2024, subject to customary closing conditions, including receipt of required regulatory approvals and approval by Alimera shareholders.

Next slide, please. ANI has a proven track record of delivering strong growth with 35% CAGR since 2021, when we delivered $216 million in revenues to our 2024 revenue guidance of $520 million-$542 million prior to this acquisition. During this period, we have successfully integrated and delivered strong results from the acquisition of Novitium. Equally important for today's discussion, we achieved approval for and launched our lead rare disease asset, Purified Cortrophin Gel, and built a rare disease organization and supporting infrastructure from scratch. For Cortrophin Gel, our guidance for 2024 is $170 million-$180 million in sales, putting us on track to deliver approximately 105% CAGR since launch in 2022.

Once Alimera is integrated into ANI, we will have three commercial assets and an expanded rare disease commercial team covering the specialties of ophthalmology, neurology, nephrology, rheumatology, and pulmonology, and a highly leverageable global infrastructure spanning over 20 countries. With Alimera, ANI's rare disease segment would account for approximately 45% of total company revenues on a pro forma 2024 basis, and we expect it to be the largest driver of the company's future growth. Next slide, please. The acquisition of Alimera will significantly improve the scope and scale of our rare disease business, with potential for substantial shareholder value creation. The acquisition will solidify the rare disease business as the largest driver of future growth. The transaction will add approximately $105 million of highly durable branded pro forma revenues and increase our geographic diversification with Alimera's established ex-US footprint, including direct operations in Europe.

ILUVIEN and YUTIQ are durable commercial assets with patent protection, high barriers to genericization, and significant future upsides. Both assets have attractive growth profiles with long runways to reach peak sales, and we believe that we can use our proven rare disease infrastructure and excellent commercial execution to unlock additional growth. Long-term clinical studies, real-world use, and ongoing trials provide a strong foundation for ILUVIEN and YUTIQ. Clinical readouts for ILUVIEN and YUTIQ are expected in later 2024 and early 2025 and have the potential to accelerate utilization of ILUVIEN and YUTIQ. Late last year, we identified ophthalmology as a key strategic market for Cortrophin Gel, which led us to establish a dedicated ophthalmology sales team in the first quarter. Alimera represents a highly synergistic complement to this priority therapeutic area.

With the acquisition of Alimera, ANI will have a nationwide sales force of approximately 48 reps dedicated to ophthalmology, which will extend our reach and ability to effectively promote all our products for difficult-to-treat late-line patients with limited therapeutic options. The transaction and our strong execution thereafter have the potential for substantial shareholder value creation. We expect high single-digit to low double-digit accretion in 2025, adjusted non-GAAP EPS, and substantial accretion thereafter. We anticipate additional $35-$38 million in 2025, adjusted non-GAAP EBITDA, inclusive of approximately $10 million in identified cost synergies. In addition to the $35-$38 million mentioned, we believe there is additional EBITDA contribution expected from accelerated growth of Cortrophin Gel within ophthalmology.

We plan to finance the transaction through a combination of cash on hand and debt while maintaining a strong balance sheet with anticipated 3.2x pro forma net leverage upon closing and significant organic delevering in 2025. Next slide, please. The acquisition of Alimera is aligned with the M&A strategy we've laid out over the past several quarters. Specifically, this transaction will expand the scope and scale of our rare disease business, strengthen one of our priority therapeutic areas, ophthalmology, which is a key area for our lead rare disease asset, Cortrophin Gel, and the overall ACTH market. And the deal gives ANI two durable assets with double-digit growth. Importantly, we expect ILUVIEN and YUTIQ to be durable given their patent protection and high barriers to genericization. Next slide, please.

Slide 11 illustrates what the combined company would look like on a pro forma 2024 basis, with total net revenues of $625-$647 million and rare disease revenues of $275-$285 million. These graphs represent a starting point as we expect to drive continued strong growth for Cortrophin Gel, ILUVIEN, and YUTIQ, as well as potential upside from revenue synergies through our stellar commercial execution capabilities. Next slide, please. ANI's rare disease business focuses on patients who are not well served by other therapies, whether this means addressing a disease that affects a small percentage of the population or underserved patients of a high-prevalence disease. ILUVIEN and YUTIQ align very well with ANI's rare disease business focus. Next slide, please. Let me tell you a little bit more about ILUVIEN and YUTIQ.

ILUVIEN treats diabetic macular edema, or DME, a chronic disease that is the leading cause of vision loss in patients greater than 4% of diabetic patients. Lisa, could we move to the next slide, please? Slide 13. Sorry for that. Just one second. Lisa, can you confirm that you're on slide? Okay. Thank you. Let me tell you a little bit more about ILUVIEN and YUTIQ. ILUVIEN treats diabetic macular edema, or DME, a chronic disease that is the leading cause of vision loss in diabetic patients. More than 4% of diabetic patients develop clinically significant macular edema. DME causes blurred vision in the early stage and may cause cumulative damage over the long term. YUTIQ treats chronic non-infectious uveitis, a disease affecting the posterior segment, an inflammation of the eye that often affects working-age adults and can lead to pain, visual impairment, and vision loss.

Both products are sustained-release intravitreal implants that deliver a continuous therapeutic microgram, submicrogram dose of the corticosteroid fluocinolone for up to 36 months, allowing for extended disease control. I'd now like to turn the call over to Chris Mutz, our head of rare disease, to discuss these products in more detail. Chris?

Christopher Mutz
Head of Rare Disease, ANI Pharmaceuticals

Thank you, Nikhil. Next slide, please. I'm pleased to be here today to share the commercial opportunity of bringing ILUVIEN and YUTIQ into ANI's rare disease business. Once the transaction is complete, we'll have three commercial products with durable growth and our ophthalmology specialty.

These three products are ILUVIEN, which treats DME in the United States and is also authorized to treat DME and non-infectious uveitis affecting the posterior segment, or NIU-PS, in 17 European countries in the Middle East. YUTIQ for the treatment of NIU-PS in the United States. And, of course, our lead product at ANI Pharmaceuticals, Cortrophin Gel, which treats, among other indications, severe acute and chronic allergic and inflammatory conditions affecting the eye and its adnexa. Each of these products alone has demonstrated strong growth in their own right, and when combined, will propel us forward for many years to come. Next slide, please. ILUVIEN and YUTIQ are highly complementary to our recent commercial launch into ophthalmology with Cortrophin Gel. Alimera recently expanded its U.S. commercial team by approximately 20%-35 field sales specialists.

I'm excited to say that after the acquisition of Alimera, we will be able to expand our reach with a combined sales team of approximately 45 sales specialists. This will enable us to call on over 3,600 ophthalmologists for the highest priority across all three products. In our analysis, we found significant overlap between ANI's and Alimera's ophthalmology call points, with at least a 50% overlap among the ophthalmologists with the highest prescribing potential. Our combined team will have increased reach and frequency, driving greater awareness of the products and identification of patients that can benefit from treatment. In addition, our complementary patient support capabilities will allow us to streamline our activities and will ensure more patients have access to therapy. Next slide, please. Both ILUVIEN and YUTIQ are positioned for robust top-line growth.

Both are, in fact, already double-digit growth assets, and we believe bringing them under our umbrella will unlock additional value. Having a sales force that can promote all three products will accelerate growth, and we expect the customer overlap I mentioned to generate commercial efficiencies. Our success with Cortrophin Gel has demonstrated our ability to identify difficult-to-treat later-line patients like those who can benefit from ILUVIEN and YUTIQ. In addition, Alimera has ongoing clinical research and real-world evidence generation, and we expect the results to further demonstrate the benefit of ILUVIEN and YUTIQ. Next slide, please. The market opportunity for ILUVIEN in DME in the United States is significant, representing more than 50,000 underserved patients. Anti-VEGF therapy, and VEGF stands for vascular endothelial growth factor, are considered the mainstay DME treatment, and steroids are usually reserved for patients who are not well served by anti-VEGF therapy.

Providers typically cycle through anti-VEGF treatments, usually multiple anti-VEGF treatments, which doesn't always end in success given the multifactorial nature of inflammation. As shown in this slide from our market research, an estimated 75,000 patients have a suboptimal response even after treatment with multiple anti-VEGF therapies, and of those, 70% respond positively to a steroid trial. ILUVIEN is an ideal treatment option for these patients. Of those 50,000 patients, notably, less than 5,000 patients received ILUVIEN in 2023. This opportunity supports our confidence in achieving sustainable growth for ILUVIEN in the U.S. market. Next slide, please. Long-term clinical studies, real-world evidence, and ongoing trials provide a strong foundation for ILUVIEN and YUTIQ. The body of clinical data is expected to continue to grow, and we're looking forward to the data, in particular, expected in late 2024 and early 2025 from two studies. The New Day study is particularly exciting.

The clinical trial is the largest head-to-head comparison to date of any corticosteroid therapy versus an anti-VEGF therapy in the treatment of newly diagnosed patients with DME. Alimera expects top-line results from this study in the first quarter of 2025. An important second study of note, the synchronicity study, is an open-label study of YUTIQ in patients with macular edema associated with NIU-PS. Alimera anticipates top-line results in the second half of 2024. We really believe both of these studies could provide additional data on the benefits of continuous microdosing for retinal diseases and have the potential to accelerate utilization of ILUVIEN and YUTIQ. Next slide, please. The acquisition of Alimera is a truly meaningful step forward in our ongoing efforts to expand the scope and scale of our rare disease business.

ILUVIEN and YUTIQ are highly complementary to ANI's business, but this transaction also brings ANI something we have not had previously: an international footprint with direct marketing operations in several countries outside the U.S. and high-quality partnerships in key geographic regions. Alimera generates today, in 2023, approximately 30% of revenue ex-U.S. and delivered 20% year-on-year growth. Next slide, please. I'd now like to turn the call over to Steve Carey, our Chief Financial Officer, to provide a financial overview and transaction details.

Stephen Carey
CFO, ANI Pharmaceuticals

Thank you, Chris. Yes, thank you, Chris. And if we could please advance to slide number 22. Slide number 22 lays out the financial details of the proposed transaction. The transaction values Alimera at approximately $381 million in upfront consideration.

We expect to acquire Alimera for $5.50 per share in upfront cash consideration, plus a CVR worth up to a total of $0.50 per share based upon the achievement of certain net revenue targets in 2026 and 2027. ANI will also repay $72.5 million of Alimera debt net of the estimated Alimera cash at the time of close, which we approximate to be $11 million. Potential payouts of the CVR are based upon achieving certain levels of revenue in 2026 and 2027 that are above our base case scenario. They are comprised of up to $0.25 per share measured on 2026 revenue performance for ILUVIEN and YUTIQ between $140 million and $150 million, and up to $0.25 per share measured on 2027 revenue performance for ILUVIEN and YUTIQ between $160 million and $175 million.

The CVRs begin to pay out once the low end of the hurdle is achieved and cap out at the high end of the hurdle. They pay ratably within these earn-out bands. If achieved, the 2026 portion of the CVR would pay out in the first quarter of 2027, and the 2027 portion of the CVR would pay out in the first quarter of 2028. The maximum $0.50 per share payout under the CVR, if fully achieved, approximates $29 million. The acquisition will be funded using a combination of ANI cash on hand and incremental debt. ANI has obtained $280 million of committed financing from J.P. Morgan and Blackstone to fund the deal. Following completion of the transaction, ANI expects pro forma net leverage of 3.2 turns at the time of close, with rapid deleveraging thereafter from a combination of growth and cash flow generation.

As Nikhil mentioned, we expect to realize approximately $10 million of cost synergies and single, excuse me, and high single-digit to low double-digit EPS accretion in 2025. These metrics do not include additional Cortrophin revenue synergies, which we expect to achieve. The transaction is expected to close in late third quarter of 2024, subject to customary closing conditions, including receipt of required regulatory approvals and approval by Alimera shareholders. If we could please advance to slide 23. With that, the team and I would like to turn the call over to the operator and open up the Q&A session. Thank you. The call is now open for your questions.

Operator

If you would like to ask a question at this time, please press Star 1 on your telephone keypad. You may remove yourself at any time by pressing Star 2.

Once again, if you would like to ask a question at this time, please press Star 1. Our first question will come from Gary Nachman with Raymond James. Please go ahead.

Gary Nachman
Analyst, Raymond James

Hey, guys. Good morning. This is Dennis on for Gary. Thank you for taking our questions and congrats on the acquisition. Just first, previously, you had highlighted that M&A was at the top of your corporate priorities. Now that this acquisition is announced, can you just run through what your corporate priorities look like now and where debt repayment sits in that list? And then I've got a couple of follow-ons after that.

Nikhil Lalwani
President and CEO, ANI Pharmaceuticals

So thank you, Dennis. And thank you for joining the call.

Look, at this point, in the near term, ensuring that we first close this acquisition, integrate the acquisition, and drive the rare disease business, and continuing to expand rare disease as the largest driver of ANI's growth is at the top of our priorities. And as you're well aware, we also have a genetics business that's delivering high—that we believe can deliver high single-digit, low double-digit growth, and coming from investment in R&D for the genetics business as well as operational excellence. So I would say those are the top two corporate priorities.

Gary Nachman
Analyst, Raymond James

Okay, great. And then you mentioned that both Alimera assets have high barriers to generic. But can you just talk a bit more about the IP estate for both products that got you comfortable with the long-term revenue potential? And then you also highlighted that this transaction expands the footprint ex U.S.

Do you expect international to be a large growth driver moving forward, and will you be focused on expanding that even more post-acquisition? Thanks so much.

Nikhil Lalwani
President and CEO, ANI Pharmaceuticals

Yeah, thank you. Thank you again. So look, we spent a lot of time evaluating potential generic pathways, and we believe that the drug device dosage form, the regulatory complexity, and the associated cost of development are significant barriers to entry. So that's on the question of genericization, and that's why we believe that these assets are durable and have longevity. And then to your second question on international expansion, one of the benefits of this transaction is the addition of an international footprint outside the U.S. As we mentioned, as Chris mentioned, approximately 30% of Alimera's revenues comes from countries outside the U.S., including direct marketing operations in Europe. And that gives us an international footprint that we could leverage in the future.

Gary Nachman
Analyst, Raymond James

Okay. Thanks so much. And congrats again. Thank you.

Operator

Thank you. Our next question will come from Les Sulewski with Truist Securities. Please go ahead.

Les Sulewski
Analyst, Truist Securities

Good morning. Thank you for taking my questions and congrats on the transaction. I have three questions here. Just remind us, I guess, on the IP duration and any potential royalties that are due on ILUVIEN and YUTIQ. Then second, just talk about payer coverage and the landscape there. Then third, on label expansion potentiality. You did mention abbreviated retinal path. What is the sizing potential there? And is there any potential for these products to pursue other indications such as wet or dry AMD?

Nikhil Lalwani
President and CEO, ANI Pharmaceuticals

Thank you. Yeah. Good morning and thank you, Liz, for your question.

So the first question on IP, as I just mentioned, we spent a fair bit of time evaluating the IP landscape as well as the pathway to generic entry, as you would expect. We have a little bit of expertise in that area, and we believe that the drug device dosage form, the regulatory complexity, and the associated cost of development are significant barriers to entry. With regards to the royalty, I'll let Steve answer that question. But before I do that, just to sort of keep going myself, your question regarding the payer coverage. Both the payer coverage and reimbursement is currently excellent for ILUVIEN and YUTIQ. And of course, as you would expect, we will evaluate options to improve the coverage and reimbursement so more patients can get access to these important therapies.

Patient support is one of our strong suits at ANI with Cortrophin Gel, and we look forward to building upon that with ILUVIEN and YUTIQ. Regarding the label expansion to other indications, we're not prepared to speak at this time about our plans in that area. But I'll hand it to Steve to just talk about your question on royalties that are due on the products.

Les Sulewski
Analyst, Truist Securities

Yes. Thanks, Nikhil, and thanks, Liz.

Christopher Mutz
Head of Rare Disease, ANI Pharmaceuticals

Yeah. And as part of the deal, we will step into the shoes of Alimera in terms of both the royalty structure that is due on the products as well as the contingent consideration payouts that are part of Alimera's acquisition of YUTIQ last year.

Operator

Thank you. Our next question will come from Oren. Our next question will come from Oren Livnat with H.C. Wainwright. Please go ahead.

Oren Livnat
Analyst, H.C. Wainwright

Thank you. I have a couple.

Just first, can you help us understand the difference between these two products? I understand they're both steroid intravitreal implants. I'm not sure how different they are. Also, differential pricing across these two products and different indications, presumably. And just, I guess, help us understand looking forward for growth opportunities across these products and indications. You have a slide calling out DME market dynamics, not so much for the uveitis indication. On the other hand, my understanding is uveitis is more of a, I guess, orphan indication such that it would go in your rare disease business. Or are you looking at DME in the same way since it's sort of like late-line therapy and basically treating it like a rare disease launch? And I follow up to that.

Nikhil Lalwani
President and CEO, ANI Pharmaceuticals

Sure. Thank you. Your question, I think your latter question regarding the growth. So we'll separate it.

So in DME, there are, as Chris mentioned, right, there are over 50,000 patients who are candidates for ILUVIEN, even when just considering later lines of therapy, right? So these are patients for which multiple iterations or multiple anti-VEGFs may not have been effective, and they have responded positively to steroid trial. And last year, fewer than 5,000 of these patients were initiated on ILUVIEN therapy, right? We believe a newly combined sales team of 45+ reps will be able to increase the reach and frequency for ILUVIEN. And then for YUTIQ, as you mentioned, that in uveitis affecting the posterior segment, there is a very high unmet need for safe and effective therapies. And the significant growth that has been seen in YUTIQ since launch reflects that high unmet need.

Your first question, look, ILUVIEN treats DME, right, a chronic disease that is the leading cause of vision loss in diabetic patients. And YUTIQ treats chronic non-infectious uveitis, right, which is a disease affecting the posterior segment and inflammation of the eye that often affects working age adults and can lead to pain, visual impairment, and vision loss. I believe you have some follow-on questions, Oren. Pricing difference?

Oren Livnat
Analyst, H.C. Wainwright

Yeah. Well, first, is there a substantial pricing difference across those two products and indications?

Nikhil Lalwani
President and CEO, ANI Pharmaceuticals

We are not speaking to sort of pricing difference and gross nets at this time.

Oren Livnat
Analyst, H.C. Wainwright

Okay. And you call out the clinical trials, which sound like they're more commercial differentiation and support objectives there.

Can you, I guess, qualify how important those are to your growth assumptions, base case, or upside optionality there in terms of what results you want or need to see there to support the sustained growth of these products? And I have one last follow-up after that.

Nikhil Lalwani
President and CEO, ANI Pharmaceuticals

Thanks. Sure. Yeah. Thanks, Oren. Yeah. Look, long-term clinical studies and real-world evidence already provide a strong foundation for ILUVIEN and YUTIQ. And this body of clinical data is expected to continue to grow with both the new day study as well as synchronicity. The new day is particularly exciting because it's the largest head-to-head comparison to date of any corticosteroid therapy and anti-VEGFs in the treatment of newly diagnosed patients with DME, so using it earlier in the treatment algorithm. Our deal model does not count on positive readouts and positive readouts from this study.

There is, as I said, there's already long-term clinical studies and real-world evidence that provide a strong foundation. Of course, as the Alimera team who has been working so hard on the new DME studies and the execution of that study, they strongly believe that this will accelerate, right? This will provide additional data on the benefits of continuous microdosing for retinal diseases and will accelerate utilization of ILUVIEN. But that is not factored in our deal model. That is an upside to the deal model for us. Okay.

Oren Livnat
Analyst, H.C. Wainwright

And just lastly, just separate from when you talk about durability of the growth profile of these assets, separate from generic risk or direct generic risk, can you just talk about the landscape competitively in later-line DME therapy or even first line and how that might affect the population that potentially falls to your line of therapy, whether it's gene therapy and development or others? How should we think about it? Is there anything we need to watch out for positively or negatively that might affect that in the competitive landscape?

Nikhil Lalwani
President and CEO, ANI Pharmaceuticals

Yeah. Look, there is still a high unmet need both in DME as well as NIU-PS. And there are new therapies in development to address those needs. But look, we see ILUVIEN and YUTIQ as durable assets that will have a place in the treatment armamentarium.

Oren Livnat
Analyst, H.C. Wainwright

All right. I appreciate it. We'll catch up with you on a follow-up.

Nikhil Lalwani
President and CEO, ANI Pharmaceuticals

Thank you, Oren.

Operator

Thank you. As a reminder, if you would like to ask a question, please press star one at this time. Our next question comes from Tim Chiang with Capital One. Please go ahead.

Timothy Chiang
Analyst, Capital One

Hi, thanks. Nikhil, Stephen, I just had a couple of questions. Could you comment on just what the gross margin profile for these two products are? Are they comparable to your gross margins in the mid-60s at this point?

Nikhil Lalwani
President and CEO, ANI Pharmaceuticals

Okay. Good morning. And thanks for the question. The addition of these products into ANI's portfolio will be a benefit to the company's aggregate gross margin profile. And these products are significantly higher gross margin profile than the company's average.

Timothy Chiang
Analyst, Capital One

Okay. Great. And then I know you had a line about the overlap in terms of the ophthalmologists that prescribe Cortrophin and then the ophthalmologists that prescribe YUTIQ and ILUVIEN.

Could you talk a little bit about how you're going to capitalize on that? Also, how do you sort of co-market all of these products in one bag to the ophthalmologist? Is Cortrophin still going to be the first detail?

Stephen Carey
CFO, ANI Pharmaceuticals

Yeah. Thank you for that question, Tim. And I'll start, and then Chris can jump in. I mean, look, as Chris mentioned in his remarks, there is more than 50% overlap between high-potential prescribers of Cortrophin and ILUVIEN/YUTIQ. And one of the things that Chris and his team have proven over the past three years is our ability to look at these high-potential, look at the prescriber landscape, but also look at late-line treatment options for underserved patients or for patients who can benefit from other therapeutic options. And we plan to bring that approach and build on all the work that the Alimera team has done, right?

Again, as we talked about, you would have picked up that our game plan right now is the Alimera team has about they increased their sales force to about 35 reps, so increased it by 20% to about 35 reps. Our plan is to combine the smaller team that we had launched for ophthalmology earlier this year and then basically have approximately a 45% sales team that carries all three products, right? Cortrophin, ILUVIEN, and YUTIQ. I'll turn it over to Chris to see if he wants to add anything.

Christopher Mutz
Head of Rare Disease, ANI Pharmaceuticals

Yeah. No, I think the other advantage that we have really is a very robust set of data from physician prescribing as well as patient data that we marry together to really understand at the physician level across those targets that we'll be focusing, where our conversations should be focused on in terms of what products.

So I think we feel comfortable, and with a very skilled sales team as well, we feel comfortable really thinking about this on a physician-by-physician level as a starting point. And we think these three products really give a tremendous advantage when the sales representative, sales specialist in front of the physician, that they're going to have a patient that would be appropriate for one of these three products.

Timothy Chiang
Analyst, Capital One

Okay. Great. And I guess just maybe one la st question is, obviously, anti-VEGFs, they're widely prescribed, but they do have some shortfalls. A lot of patients can't tolerate them for long periods of time. It seems like the Alimera products, they're pretty long-acting products, right? I mean, could you just, I mean, in your due diligence, could you just talk about what drove your interest in these long-acting products?

And where do you see the longer-term opportunity here in terms of what do you see peak sales potential for these two drugs?

Nikhil Lalwani
President and CEO, ANI Pharmaceuticals

Yeah. So I can start, and Chris, you can step in. So I think, and thank you again for your question, Tim. Look, we're not speaking to exact peak sales potential at this time, but as we had mentioned during our prepared remarks, that we see a long runway for both products and significantly higher growth potential and consequently peak sales for both these products. And as we've talked about a couple of times, the durability of these assets, the long-acting nature of both products is a differentiator, right, and plays an important role for serving patients for whom other therapeutic options are needed in the respective disease states.

Going back to your question of sort of what made us interested, look, this acquisition is exactly in line with the M&A strategy that we've been speaking about for the past several quarters, right? It expands scope and scale of our rare disease business. It's in a priority therapeutic area, which is one that overlaps with Cortrophin, i.e., ophthalmology. And then it also gives us two growing and durable assets. And look, in terms of going forward, what this does for us is it gives ANI two growth vectors, right? Rare disease that we always had, and then also in ophthalmology, even within rare disease. So that's the sort of strategic rationale behind the deal. Obviously, we've spoken in great detail about the potential for substantial shareholder value creation from this deal, right?

Whether it be the expected high single-digit to low double-digit accretion in 2025, adjusted non-GAAP EPS, and substantial accretion thereafter, the additional $35 million-$38 million in 2025 adjusted non-GAAP EBITDA, which is inclusive of approximately $10 million in cost synergies. But there's additional EBITDA contribution from accelerated growth of Cortrophin Gel in ophthalmology, which is not included in these numbers, right? So there's potential for substantial shareholder value creation and strategically aligned with our plan. So Chris, would you like to add anything?

Christopher Mutz
Head of Rare Disease, ANI Pharmaceuticals

No, I think you covered it well.

Timothy Chiang
Analyst, Capital One

Thanks. And maybe just one last question, if I may. It's just that there are some additional studies that you're inheriting, right? I mean, are you going to continue to spend on R&D for some of these programs to support both YUTIQ and ILUVIEN?

Nikhil Lalwani
President and CEO, ANI Pharmaceuticals

Yeah. I think we're not prepared to comment on this at this time.

Obviously, we've just signed the deal. We're focused on closing and integration. The Alimera team will continue to do the great work that they have done, right? Rick and team have done a tremendous job building this ophthalmology franchise. We will look forward and are humbled to have the opportunity to carry their good work forward.

Timothy Chiang
Analyst, Capital One

Okay. Great. Thanks. Thanks, Tim.

Operator

Thank you. At this time, it appears we have no further questions in queue. I would like to turn the call back to Nikhil Lalwani for any additional or closing remarks. Yeah.

Nikhil Lalwani
President and CEO, ANI Pharmaceuticals

Thank you, Todd. Thank you again, everyone, for joining our call today to discuss ANI's proposed acquisition of Alimera Sciences. As you have heard, we were delighted to share the details of this important transaction and look forward to updating you as we move forward. Thank you so much.

Operator

This does conclude today's call.

We thank you for your participation. You may disconnect at any time.

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