ANI Pharma (ANIP) Q3 2026 Earnings Call Transcript

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DATE

Thursday, Nov. 5, 2026

CALL PARTICIPANTS

• President and Chief Executive Officer - Nikhil Lalwani
• Senior Vice President and Chief Financial Officer - Stephen Carey
• Senior Vice President and Head of ANI's Rare Disease Business - Christopher K. Mutz
• Chief Medical Officer - Gary Powell
• Investor Relations - Irina Rivkind Koffler

TAKEAWAYS

• Total Net Revenue -- $290.8 million, representing 28% growth year over year driven by rare disease, brand royalties, and generic portfolio performance.
• Rare Disease Net Revenue -- $160.9 million, increasing 36% year over year as the company continues its transformation into a rare disease-focused organization.
• Purified Cortrophin Gel Revenue -- $138.7 million, up 36% year over year primarily due to increased volume and the initial return on investment from the gout indication expansion.
• Generics Revenue -- $104.5 million, growing 11% year over year behind strong market demand, commercial outperformance, and new product launches.
• ILUVIEN Net Revenue -- $22.3 million, up 34% year over year reflecting volume growth in the U.S. and international segments and favorable timing of international shipments.
• Non-GAAP Gross Margin -- 61.8%, an increase of 2.6 percentage points from the prior year period due to a favorable shift in product mix and royalty revenue contributions.
• Adjusted Non-GAAP EBITDA -- $82.3 million, a 40% increase year over year reflecting top-line growth and favorable gross margin trends.
• Adjusted Non-GAAP Diluted EPS -- $2.70, compared to $2.04 in the prior year period.
• Full Year 2026 Revenue Guidance -- $1.085 billion to $1.125 billion, narrowed from the previous range of $1.08 billion to $1.14 billion.
• Revised Cortrophin Gel Guidance -- $480 million to $500 million, lowered from $520 million to $540 million to account for specialty pharmacy network capacity constraints and slower gout patient conversion.
• Revised Adjusted EBITDA Guidance -- $290 million to $300 million, raised from the previous range of $285 million to $300 million based on year-to-date profitability.
• Revised Non-GAAP EPS Guidance -- $9.37 to $9.71, an increase from the previous range of $9.19 to $9.69.
• Egetis Therapeutics Acquisition Offer -- $560 million, representing an enterprise value of approximately $434 million net of proceeds from a priority review voucher sale.
• Emcetate Annual Peak Sales Potential -- Over $300 million, according to management estimates for the treatment of MCT8 deficiency in its approved indication.
• Emcetate Pricing -- $950,000, representing the estimated annualized wholesale acquisition cost based on a $74,000 price per pack of 60 tablets and average daily dosing.
• Cash and Liquidity -- $420.8 million in unrestricted cash as of Sept. 30, 2026, representing a $135.2 million increase since the end of 2025.
• Operating Cash Flow -- $83.8 million in the third quarter, which management noted as a record for the company.
• Share Repurchase Activity -- $20 million, representing the year-to-date repurchase of 275,000 shares under a $100 million authorized program.
• Harmony Biosciences Royalty Revenue -- $11.5 million, consisting of $9.5 million in royalties from Wakix sales and $2 million from a development milestone.
• Generic Product Launches -- 16 products, representing the total number of generic launches year-to-date.
• Pro Forma Net Leverage -- 2.7 times, the expected trailing 12-month leverage ratio following the closing of the Egetis acquisition.
• Gout Prescriber Growth -- 67%, representing the quarter-over-quarter increase in new prescribers in the gout expansion segment.
• Gout Patient Funnel -- Twofold, representing the growth in new patient cases initiated in the third quarter compared to the second quarter.

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RISKS

• Lalwani stated, "Cortrophin Gel net revenues came in lighter than we expected when we outlined guidance last quarter," noting that high demand for gout treatment pressured specialty pharmacy network capacity and slowed processing times for multiple indications.
• Carey warned that the Egetis acquisition is expected to be "dilutive to adjusted non-GAAP EPS in year 1 driven by investments to support the U.S. commercial launch."
• Lalwani noted that while gout demand is high, primary care and podiatrist offices are ramping up ACTH enrollment capabilities "longer than we had anticipated," creating a bottleneck in revenue conversion.

SUMMARY

ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) reported third quarter results that demonstrated 28% year-over-year revenue growth and announced a strategic offer to acquire Egetis Therapeutics for $560 million to expand its rare disease portfolio. Management lowered full year revenue guidance for Cortrophin Gel due to specialty pharmacy capacity constraints and slower-than-anticipated conversion of a doubling patient funnel in the gout segment. The company reported record quarterly operating cash flow of $83.8 million and raised its full year adjusted EBITDA and non-GAAP EPS guidance based on generic segment outperformance and improved margins. The Egetis acquisition brings Emcetate, the first approved treatment for MCT8 deficiency, which management expects will achieve peak annual sales exceeding $300 million.

• The company intends to fund the Egetis acquisition using $300 million in cash on hand and up to $300 million in new debt via a bridge financing facility with JPMorgan.
• Management reported that 60 U.S. patients are already receiving Emcetate through an expanded access program, providing a clear starting point for the commercial launch.
• ANI Pharmaceuticals identified a potential addressable market of 285,000 patients for acute gouty arthritis flares, a segment management described as significantly underpenetrated.
• The company reported that over 100 U.S. patients have been genetically confirmed with MCT8 deficiency, a condition with a median life expectancy of 35 years and no prior approved therapies.
• Lalwani noted that despite the guidance revision for Cortrophin Gel, the product is still expected to deliver year-over-year growth of over 40% at the midpoint of the revised range.
• The company announced positive 24-month data from the SYNCHRONICITY clinical trial for ILUVIEN in chronic non-infectious uveitis, which management is leveraging to increase market share among retina specialists.

INDUSTRY GLOSSARY

• ACTH: Adrenocorticotropic hormone, a therapeutic category used for various inflammatory and autoimmune conditions including acute gouty arthritis.
• EAP: Expanded Access Program, a potential pathway for patients with serious diseases to access investigational or newly approved medicines outside of clinical trials.
• MCT8 Deficiency: A rare X-linked genetic disorder that affects thyroid hormone transport, leading to severe intellectual and physical disabilities.
• NIU-PS: Non-infectious uveitis of the posterior segment, a chronic inflammatory eye disease.
• SEK: Swedish Krona, the currency used for the Egetis Therapeutics acquisition price calculation.
• Tiratricol: The active ingredient in Emcetate, a small molecule thyroid hormone receptor agonist.
• WAC: Wholesale Acquisition Cost, the list price for a pharmaceutical product as sold to wholesalers or direct purchasers.

Full Conference Call Transcript

Operator: Thank you. Good day, everyone, and welcome to today's ANI Pharmaceuticals, Inc. Third Quarter 26 Earnings Results Conference Call. Please note this event is being recorded. After the speakers' prepared remarks, there will be a Q&A session. To ask a question, please press star then 1 on your telephone keypad. If you would like to withdraw your question, please press star then number 2 on your telephone keypad. It is now my pleasure to turn the conference over to Irina Rivkind Koffler.

Irina Rivkind Koffler: Thank you, Keith. Welcome to ANI Pharmaceuticals third Quarter 26 Earnings Results Call. This is Irina Rivkind Koffler, Investor Relations for ANI. With me on today's call are Nikhil Lalwani, President and Chief Executive Officer Stephen Carey, senior vice president and chief financial officer Christopher K. Mutz, senior vice president and head of ANI's rare disease business and Gary Powell, Chief Medical Officer. Earlier this morning on November 5, 26, we released our results in the third quarter 26 via a press release that is available on our website. This call is also available via webcast and is accompanied by a slide deck that can be accessed by going to the Events section of the Investors page of our website.

During this call, we will also be discussing the terms and conditions of ANI's offer to acquire outstanding securities of Aegidus Therapeutics, which ANI announced this morning. Please refer to the transaction website at www.biopharmaoffer.com and the 8-Ks filed by ANI this morning that includes further information about the offer, including important considerations for holders of Aegidus Securities in The United States. Before we begin, I would like to remind you that we will be making forward looking statements and discussing certain non GAAP measures. Forward looking statements are subject to substantial risks and uncertainties, speak only to the call's original date, and we take no obligation to update or revise any of the statements.

During this call, we will also refer to certain non GAAP financial measures to describe our performance and have provided a reconciliation to the most directly comparable GAAP financial measures within the materials that accompany this call. The archived webcast will be available for 1 year on our website anipharmaceuticals.com. Okay. Turning to the agenda for today's call. Nikhil will provide an overview of our corporate strategy and Q3 performance, followed by an overview of our offer to acquire Aegidus Therapeutics. Gary will dive into more detail on MCT8 deficiency and MCT's mechanism of action. Christopher will discuss the commercial opportunity for and will also provide an update on our rare disease business.

Lastly, Steve will discuss our Q3 financial results and 2020 guidance. And with that, I will turn the call over to Nikhil Lalwani.

Nikhil Lalwani: Thank you, Irina. Good morning, everyone, and thank you for joining us. We are now on slide 7. At the start of 2026, we set out 3 strategic priorities designed to position ENI for long term growth. These include first, accelerating ANI's transformation into a leading rare disease company, Second, driving continued excellence in generics R&D and operations, And third, executing a disciplined capital allocation strategy. At ANI, we take pride in our virtuous cycle of growth. In which our generics and brands business generate meaningful cash flows to support our rare disease business. We are making meaningful progress against each of these priorities including with today's offer, to acquire Aegidus Therapeutics.

Before we dive into the details regarding the Aegidus offer, I want to talk you through our third quarter results at a high level and our updated guidance. Turning to Slide 8, For the third quarter, we generated $290.8 million of total for the overall business, up 28% year over year. And adjusted EBITDA of $82.3 million up 40% year over year. Rare disease net revenues grew 36% year-over-year, and we saw continued growth in generics, up 11% year-over-year. Moving to Slide 9, while we delivered strong overall results on the top and bottom line, I want to address our Cortrophin performance.

We have been clear that our goal for Cortrophin is to maximize its multiyear growth opportunity by building on the momentum in our existing specialties and by expanding our organization to capture the sizable and unique opportunity in acute gouty arthritis flares. In the third quarter, Cortrophin Gel net revenues came in lighter than we expected when we outlined guidance last quarter at $138.7 million This was primarily driven by 2 factors. First, for the Gal expansion team, we had strong demand generation in the third quarter, with a large funnel of new patient cases which doubled compared to the 2nd quarter, highlighting physician interest and a large volume of appropriate patients.

The significant volume of new gout cases put pressure on our specialty pharmacy network capacity, impacting the amount of cases that were processed for gout and also for our existing specialties of neurology, nephrology, rheumatology, ophthalmology, and pulmonology. Secondly, we increased our new prescriber base in the gout expansion by 67% compared to the prior quarter. The primary care and podiatrist offices naive to ACTH are ramping up their capabilities in navigating the Cortrophin enrollment to fulfillment process. This ramp has taken a bit longer than we had anticipated. This dynamic, coupled with the impact to our specialty pharmacy network capacity, that I just mentioned, resulted in longer than expected conversion of new gout cases to patients on therapy.

Christopher will walk you through the significant steps we have already taken to address these dynamics. This is a key priority for us in the near term, and we are already seeing improvements in getting both gout and existing specialty patients onto therapy. That said, we are revising our 2026 Cortrophin Gel net revenue guidance to $480 million to $500 million compared to $520 million to $540 million previously. Importantly, this represents year over year growth of over 40% at the mid point on this revised guidance range. And nothing we have seen changes our conviction in the gout opportunity or in the strong multiyear growth potential of Cortrophin across indications.

With respect to ILUVIEN, we demonstrated strong year-over-year revenue growth of 34%. We plan to leverage the new synchronicity study data presented at AAO in October with a focus on the retina specialist community. To return ILUVIEN to growth across global markets. With 3 quarters under our belt, we are also tightening the guidance ranges for total company net revenue, adjusted non GAAP EBITDA, and raising adjusted non GAAP EPS. Our 2026 guidance reflects significant top and bottom line growth and the strength and diversification of our business in particular, the continued outperformance of our generics business. Steve will walk you through the details later. As you can see on slide 10, year to date, we have launched 16 generics.

We also continue to hold the number 2 position in overall CGT filings. And approvals. We are proud of our team's operational execution as it was able to seize multiple opportunities and benefit from strong market demand to deliver another outstanding quarter with generics revenue of $104.5 million up 11% year-over-year. In terms of our third priority, disciplined capital allocation, we are continuing to invest in organic growth. Most visibly in the gout expansion and continuing to put a high single digit percentage of generics revenues into generics R&D. We also repurchased $20 million in shares under the share repurchase program that was authorized by our board in May. Reflecting our confidence in ANI's future. Steve will provide more details.

And finally, today, we also announced the offer to acquire Aegidus Therapeutics. Turning to slide 11. Throughout the year, we have said that we are actively evaluating opportunities to expand our rare disease business, with a focus on attractive commercial stage or newer commercial assets with durable IP that leverage our organizational capabilities. Aegidus meets each of these objectives. First and foremost, this transaction builds on our mission of serving patients improving lives, which is really at the core of everything we do at ANI. We have followed the Aegidus team closely, and we have been deeply impressed by their commitment to patients with MCT8 deficiency to the families who care for them. This is a devastating condition.

Children are born with it. Families provide around the clock care. And until very recently, there was no approved treatment. As we bring Aegidus into ANI, our commitment is to honor that work to ensure that the patients and care. Caregivers have the support they need to access the first and only approved treatment for MCT8 deficiency. Second, it expands the scope and scale of our rare disease business, broadening our commercial footprint into an additional rare disease call point with a product that has the potential to generate annual peak sales of over $300 million, in its approved indication.

Third, it has a new durable goat driver emcetate is the first and only approved treatment in The EU and US for peripheral thyrotoxicosis associated with MCT8 deficiency. This is a rare disease. Impacting more than 1 thousand patients in The US alone. We will endeavor to facilitate patient diagnosis and bring this therapeutic to the appropriate patients in need. Fourth, it leverages our resources and existing rare disease expertise and infrastructure to support emcetate's commercial launch. Our commercial organization brings deep rare disease experience along with patient support, market access, and specialty pharmacy capabilities that we have built over the past 5 years with Cortrophin and ILUVIEN.

We believe we can leverage our resources and capabilities to maximize the reach and impact of emcetate in 1 of the most underserved patient communities. Fifth, it strengthens our R&D capabilities adding additional development and regulatory expertise in rare disease, along with a potential pipeline opportunity for MCT in RTH beta a separate rare indication. And finally, it diversifies our revenue base and enhances our long term growth and profitability profile. Turning to Slide 12. M Cetate represents an ideal product to add to our portfolio. Gary will speak to the disease, in more in more detail shortly. Emcetate was approved in Europe in February 2025, and in The US in September 2026.

Emcetate became commercially available in The US last week on October 27. We estimate that approximately 1 in 70 thousand males are impacted by MCT8 deficiency globally. Today, more than a hundred US patients have been genetically confirmed and approximately 60 US patients are already receiving emcetate 20 expanded access program or EAP. This EAP gives us a clear starting point for The US launch with a significant opportunity to identify, diagnose, and treat additional appropriate patients over time. emcetate has durable growth runway supported by new chemical entity exclusivity orphan drug exclusivity in both The US and The EU, an Orange Book listed patent extending into mid-2045.

We believe we have put forward an attractive offer that allows Aegis shareholders to realize the forward looking value of emcetate and we are pleased with the unanimous support we have received from the Aegidus board of directors and significant shareholders controlling approximately 42% of shares. Slide 13 outlines the financial terms. We are offering to acquire Aegidus for a total equity consideration of $560 million. This represents an enterprise value of approximately $434 million net of the $95 million in cash proceeds that Aegis has agreed to receive from the sale of its pediatric rare disease priority review voucher which was announced yesterday. This is an all cash deal.

And we will fund it through a combination of existing cash on hand and up to $300 million in debt surrounded by new committed bridge financing facility from JPMorgan. Upon closing of the deal, expect trailing 12 month pro forma net leverage to be approximately 2.7x. From a financial perspective, the deal enhances our growth profile. With emcetate in the early launch phase, we believe we can maximize its reach by leveraging our resources and rare disease infrastructure. That said, we do expect it to be diluted to adjusted non GAAP EPS in year 1 driven by investments to support the U.S. commercial launch.

We expect the deal to close in late 26 or early 27, subject to customary closing conditions. And with that, I will turn the call over to Dr. Gary Powell our chief medical officer, to provide an overview of MCT deficiency. Gary?

Analyst: Thank you, Nikhil, and good morning, everyone. And I am very pleased to be joining today's call to introduce you all to MCT8 deficiency and also to MCT8. MCT8 deficiency is a rare endocrinologic disease, and it is characterized by 2 somewhat conflicting or contrasting conditions. 1 is hypothyroidism in the central nervous system that can be quite severe. And at the same time, peripheral thyrotoxicosis. On slide 15, you will see that MCT deficiency is caused by mutation in the SLC16A2 gene that is located on the X chromosome, and this encodes MCT 8, which is also known as the monocarboxylate transporter 8. This is a protein that carries thyroid hormone into the cells.

Because it is located on the X chromosome, it is X linked, and it affects almost entirely males. And as and with an estimated birth incidence of approximately 1 in 70 thousand births. This gene was only identified in 2004 as the genetic cause of MCT8 deficiency. So this is a relatively newly characterized disease. What makes it so distinctive, as I mentioned, is that patients are both hypothyroid, in the CNS and hyperthyroid in the periphery. When these patients do not have a functioning MCT8 transporter, the active thyroid hormone t 3 cannot enter specific target cells. And in the brain, this leaves the brain deprived of thyroid hormone.

However, in the peripheral tissues, T3 is able to enter those tissues through other transporters it is not MCT reliant, and therefore circulating t 3 levels are high. In the brain, the brain keeps sensing that there is no-- no T3. It keeps making more t 3 to get to the brain. But that t 3 is only becoming toxic in the periphery. This persistent thyrotoxicosis in the periphery causes damage in tissues such as the heart and muscle. So these symptoms of MCT8 start very early, and become noticeable often at 3 to 6 months of age when children begin to miss normal developmental milestones.

Delay in diagnosis means that they are typically diagnosed around age 2, and these thyroid hormone lab tests show a characteristic pattern of elevated t 3, and then that can be confirmed by genetic testing of MCT8. This is a very severe life shortening condition that is characterized by profound intellectual and physical disabilities that are compounded across different organ systems requiring lifelong chronic 24 hour often care. Median life expectancy is about 35 years, and as many as 30 percent of patients die in childhood. A frequent cause of mortality is sudden death, which is likely linked to the underlying cardiac abnormalities from the thyrotoxicosis.

Based on this birth incidence and this life expectancy, we ask estimate that there are more than 1 thousand people living with MCT8 deficiency in The US today. More than 100 of these patients have been genetically identified to date, and as Nikhil already said, there was no prior approved treatment for MCT8 deficiency until emcetate came along. So turning to slide 16, we are going to talk a little bit about the profound intellectual and physical disabilities that come with MCT deficiency. there is extreme burden to the patients and caretakers for MCT8 deficiency. On the left, you will see the effects of low thyroid hormone in the central nervous system. This results in a global developmental delay.

It affects speech, cognition, and delayed myelination of the central nervous system can lead to epilepsy. And then neuromuscular and skeletal symptoms such as hypotonia, or low body tone, dystonia, and spasticity. Most patients are unable to sit or walk independently, and many are unable to swallow because they do not have the coordination of those muscles. You look on the right, you will see the effects of the excess thyroid hormone in the rest of the body as well. These include cardiovascular effects, so elevated systolic blood pressure, resting tachycardia, or elevated heart rate.

Premature atrial contractions leading to cardiac arrhythmias, and then GI symptoms such as reflux, malabsorption, inability to swallow, as we mentioned, and then recurrent pulmonary sections based on aspiration, they are not able to swallow, and a hypermetabolic state which ultimately leads to failure to thrive when patients have low body weight, poor heat intolerance, and also increased perspiration. This failure to gain weight is associated with a poor prognosis, and an increased death in this patient population. So this peripheral thyrotoxicosis is a central driver of morbidity in this disease state.

On slide 17, we will take a look at the mechanism of action, which I briefly went through earlier. emcetate is a small molecule thyroid hormone receptor agonist. what is important is that it enters cells independently of the MCT8 transporter. It restores thyroid hormone signaling in MCT8 dependent tissues, including the brain, and so it acts where T3 cannot normally reach. And then second, because it is reaching the brain, it reduces the elevated serum T3 levels that are being produced in the periphery and cause thyrotoxicosis in the body. On slide 18, we can show that emcetate's FDA approval was supported by robust clinical evidence, and there were 2 key studies that were involved.

First is called Retriact, and this was a 30 day randomized, double blind, placebo controlled withdrawal study So patients who are already taking emcetate were randomized either to continue treatment or to switch to placebo. In the patients switched to placebo, total t 3 thyroid hormone rose about 1.5x faster than in those patients who continued on the emcetate therapy. Half of the patients on placebo, 4 out of 8 patients, needed rescue because their T3 then rose above the normal range. Compared with only 1 of 7 who were receiving emcetate therapy. Every patient switched to placebo had a larger increase in T3, than any patient who received emcetate. Excuse me.

The second set of evidence comes from the TRIAC trial 1, which was a 12 month open label study. So in this study, mean total T3 fell from 323 to 180 nanograms per deciliter. Which is a highly significant reduction in t 3. Key clinical markers of thyrotoxicosis also improved, including systolic blood pressure, and heart rate with both decreased, and importantly, body weight for age also increased. On slide 19, we will see that there are other 3 independent sources of real world evidence which also support these clinical trials. They are not included in The U. S. Prescribing information.

These 3 studies include the Erasmus Medical Center cohort study, which followed patients for up to 6 years and examined the effect of M. Acetate on T3 as well as clinical markers of thyrotoxicosis. there is the EMC survival study, which examined treated versus untreated patients in a cohort of more than 600 individuals, which is by far the largest MCT patient cohort to be ever studied. This real world retrospective study compared treated versus untreated patients based on survival, and we expect findings of these studies to be published by the Erasmus Medical Center in the near term. And finally, we have data from The US expanded access program as compared with prior clinical studies.

With that, thank you for listening. I will turn the call over to Christopher K. Mutz to discuss our planned commercial strategy for emcetate. Christopher?

Christopher K. Mutz: Thank you, Gary, and good morning, everyone. I will begin on Slide 21. This potential transaction offers a compelling ultra rare disease opportunity to serve patients and improve lives in an area of tremendous unmet need and in the therapeutic area where our team has extensive background. Number of us on ANI's commercial team came from Alexion, where we focused on patient identification and facilitating access for ultra rare disease medicines including for the launches of Soliris in PNH and aHUS and Strensiq in hypophosphatasia.

We bring the experience and capabilities required for the emcetate launch, and we are excited to join our colleagues at Aegidus to begin engaging with this physician community as well as the patients and families whose lives have been so profoundly impacted by MCT8 deficiency. Part of the transaction, we would be acquiring the established Aegidus commercial presence with built in prescriber, payer, and patient advocacy relationships and look forward to leveraging the resources that ANI can contribute to accelerate the identification and treatment of patients who can benefit from emcetate.

It is a real testament to the team at Aegidus that as of today, nearly 300 patients around the world are being treated with emcetate when you combine The US expanded access program the global managed access program. Our first commitment is ensuring these patients, their families, and caregivers have our support to continue emcetate treatment. Turning to slide 22. Emsatate was approved in Europe in February 2025, and by the FDA on September 28, 2026, as the first and only therapy for MCT8 deficiency. From a commercial standpoint, 2 key features stand out. First, the label is broad. emcetate is indicated for the treatment of peripheral thyrotoxicosis in adults and pediatric patients with MCT8 deficiency with no age restriction.

So every patient with a confirmed diagnosis is eligible for treatment. emcetate enters the category where there are no FDA approved alternatives, and has durable patent protection into mid-2020. This exclusivity gives us significant runway to invest in commercial operations to bring this important therapy to more patients in need. Commercial product is already available in the US, and Aegidus is engaging with physicians on prescriptions, enrollment, and access so that the EAP patients can transition to reimbursed medication. Turning to slide 23. Of the more than 1 thousand patients who are living with MCT deficiency in The US, over 100 have been diagnosed and validated by the Aegidus team.

These are actively managed patients with a confirmed mutation and an identified treating physician. That is an unusually strong starting point for an ultra rare disease launch. Of those patients, about 60 are receiving emcetate today through the expanded access program, and the rest have been diagnosed and identified but are not yet on therapy. The EAP patients are concentrated at 17 sites across the country with more than 65 percent managed across just 6 centers. These sites give us a focused place to start, and the physicians there have become reference points for colleagues who identify new patients.

It is truly remarkable how much impact the Aegidus team has already had in engaging this patient and physician community, and we believe that we can keep identifying and helping many more patients over time. Turning to slide 20 4. This launch brings together complementary strengths, Aegidus has built a dedicated US launch team with commercial and medical employees already hired and onboarded, including key account managers and regional medical directors in each territory. And I plan to supplement this team with our additional resources and scale to drive higher awareness of the MCT8 deficiency and new availability of an FDA approved treatment. Aegidus has already established a patient support program with PantherRx rare.

A leading specialty pharmacy well known for its expertise in rare disease launches. The company also has strong relationships with patients, caregivers, and advocacy groups. ANI brings a rare disease team with extensive expertise in ultra rare indications infrastructure to identify niche patient populations, and proven capabilities in securing market access and navigating reimbursement. We also bring the resources to fully support the launch and maximize emcetate's potential. The launch will be initially focused on the following priorities. First, securing payer coverage. Aegidus has engaged payers well ahead of approval, including the 3 largest pharmacy benefit managers and more than a third of state Medicaid plans.

Because there is nothing else approved for MCT deficiency, we expect there to be a path to access and reimbursement from both commercial and Medicaid payers and we will leverage ANI's expertise in patient support ensure patients who are prescribed emcetate can access it. Second, the effort will focus on converting patients from the expanded access program to commercial drug. Continuity of care is a top priority. Aegidus has already initiated significant activities to accomplish this goal, and we look forward to continuing their momentum into 2027 post close.

Beyond those EAP patients, we will work with the physicians and target sites to expand the population of patients on treatment, starting with the diagnosed patients who are not yet on therapy, many due to logistical or other limitations of the EAP program. Finally, we will work to increase awareness of emcetate and MCT8 deficiency to drive higher diagnosis. Both for patients living with the disease today and for those newly born with it each year. With a small team established preapproval, Aegidus has successfully found patients through medical conferences, field engagement, and data analytics. Our increased investment in patient identification capabilities and scale will extend that reach. Ultra rare disease, an approved therapy often changes the diagnostic picture.

Physicians now have a reason to test for this ultra-rare disease. Aegidus has seen this firsthand in Germany where the number of identified patients had doubled in the first 15 months after launch, and similar patterns have been seen in comparable ultra rare disease launches in The U. S. With that, let me turn to our third quarter commercial update for Cortrophin and Iluvien. Moving now to Slide 25 and the overall opportunity for Cortrophin Gel. the overall market is expected to grow 28% in 2026 to reach approximately $1.3 billion in sales with Cortrophin expected to grow 38% to 44% year over year in 2026.

Cortrophin had strong multiyear growth potential with addressable patient populations across indication significantly underpenetrated as shown on slide 26. There are a large number of prescribers and patients who are naive to the ACTH category across all therapeutic areas, And I am steadily reaching this segment both with our specialty indications and with our gout expansion in primary care and podiatry. We have been encouraged by the continued demand we are seeing in the field remain confident in the significant multiyear growth trajectory for Cortrophin. We detail our third quarter performance on Slide 27. Starting with existing specialties, we continue to drive momentum for this segment of our core Cortrophin business.

We have strong demand across indications and momentum has continued into October with the highest number of new cases initiated. Turning to our gout expansion. Demand trends and leading indicators remain strong. In the third quarter, we increased the breadth of prescribing with a 67% increase in prescribers over the second quarter. We also saw increased depth of prescribing with 40 percent of all primary care and podiatry prescribers initiating 2 or more cases. This translated into demand with a doubling in new cases initiated. While we are encouraged by these demand trends, as Nikhil noted, sales came in lighter than expected driven by 2 factors.

First, the significant demand generated by our new gout expansion team along with the demand momentum in existing specialties pressured our specialty pharmacy network capacity. For reference, the number of new cases initiated in 5 months since the gout expansion in May is approximately 85% higher than the 5 preceding months. Highlighting the magnitude of demand we are seeing. Simply put, the significant increase in volumes created a bottleneck in our network. This led to slower reimbursement processing in gout cases as well as cases in our existing specialties. Second, in the gout expansion, we observed a longer than expected conversion of new cases initiated to patients on therapy.

Our gout expansion is focused on primary care physicians and podiatrists, most of whom are new to ACTH. These practices are still building familiarity with Cortrophin enrollment to fulfillment and need additional support compared to our specialist customers as they are ramping up. We have taken concrete actions to improve our specialty pharmacy network capacity, Specifically, we have strengthened the support and collaboration at existing specialty pharmacies. In addition, we have expanded our specialty pharmacy network to service regional areas of especially high demand. Importantly, we are actively evaluating further expansions to support the growth in 2027 and beyond.

In parallel, we have expanded our patient support team to further support the primary care and podiatry offices that are naive to ACTH. Our team is providing them with resources to navigate the enrollment for fulfillment process for Cortrophin. While it will take some time to realize the full benefits from these efforts, we are encouraged that we are seeing early signs of improving fulfillment trends with record volumes for existing specialties in October. In the latter portion of Q3 and into early Q4, we are already seeing modest improvements in time to first fill, showing that our efforts to improve revenue conversion are having impact.

We expect these positive conversion trends to continue throughout the quarter, We remain confident in the significant multiyear growth runway for Cortrophin. I am proud of the entire Cortrophin team and the rapid improvements we have made to our overall infrastructure, which will generate continued momentum in 2027. On slide 28, turning to our retina franchise, continue to make progress to support a global return to growth for ILUVIEN delivered $22.3 million of revenue or 34% year over year growth in the third quarter. In addition, the combined ophthalmology retina sales team has been performing extremely well with Cortrophin, with Cortrophin volumes doubling year over year.

As part of our continued focus on the long term growth opportunity for ILUVIEN, we announced the positive top line results from the phase 4 open label synchronicity clinical trial in non-infectious uveitis of the posterior segment (NIU-PS) along with 24 month data from secondary endpoints that were recently presented at the American Academy of Ophthalmology. These results are particularly relevant for retina specialists who see a large population of uveitis patients that are consistent with the patients treated in synchronicity and we had a strong favorable response to the data at AAO from the prescriber community. Our sales and marketing teams are already leveraging the synchronicity results.

In the field to build an increasing share of voice amongst retina specialists treating chronic noninfectious uveitis of the posterior segment. With that, I will now turn the call over to Steve to discuss our financials.

Stephen Carey: Thanks, Christopher, and good morning to everyone on the call. Now I will review our third quarter results and 2020 guidance in more detail. Starting with slide 30. ANI total net revenues were $290.8 million in the third quarter, up 28% over the prior year period. These revenue gains reflect strong year over year growth across ANI's diversified business, led by growth of our rare disease unit, brand royalties, and continued strong performance within our generics portfolio. Revenues from Cortrophin Gel in the third quarter were $138.7 million, up 36% from the prior year period driven by increased volume and the initial return on our investment behind the gout indication.

ILUVIEN net revenues were $22.3 million in the third quarter, growing 34% from the prior year period. This performance reflects underlying growth in both the U.S. and international segments as well as favorable year over year timing of revenues in certain international markets. In January, we entered into a transaction with Harmony Biosciences. We recognized $11.5 million of associated revenues in the third quarter consisting $9.5 million of royalty income on sales of Wakix, and $2 million of revenue associated with the remainder of our $10 million development milestone transaction. Looking forward, we expect to continue generating low single digit royalty income from sales of WAKIX under the terms of the license.

Revenues for our generics in the third quarter were $104.5 million, an increase of 11% versus the prior year. Driven by continued strength in the partner generic launch that commenced in the third quarter of 2025, contribution from new product launches, and commercial and operational outperformance. Turning to slide 31. Non GAAP cost of sales increased 20% to $111 million in the third quarter of 26 compared to the prior year period. Non GAAP gross margin in the third quarter was 61.8%,, an increase of approximately 260 basis points from the prior year period, driven by product mix and the favorable impact of the Harmony royalty revenue.

Non GAAP research and development expenses increased 4.7% to $12.3 million in the third quarter, primarily due to phasing of generics R&D spend. Non GAAP selling, general, and administrative expenses increased 32.4% to $84.2 million in the third quarter driven by our gout expansion for Cortrophin, as well as an overall increase in activities to support the ongoing growth of our business, Adjusted non GAAP diluted earnings per share was $2.70 for the third quarter, compared to $2.04 per share in the prior year period. Adjusted non GAAP EBITDA for the third quarter was $82.3 million up 40% compared to the prior year, driven by revenue gains and favorable gross margin trends.

We ended the third quarter with $420.8 million in unrestricted cash, up $135.2 million as compared to 12/31/2025. Cash flow from operations was a record $83.8 million in the third quarter and $198.8 million on a year to date basis, exceeding in the first 9 months of this year cash from operations versus the full year of 2025. This creates significant optionality for our company as we deploy our capital to create shareholder value. As of 09/30/2026, we had $616.9 million in principal value of outstanding debt, inclusive of our senior convertible notes and term loan.

At the end of the third quarter, our gross leverage was 2.2x and our net leverage was 0.7x our trailing 12 months adjusted non GAAP EBITDA of $283.2 million We are in a strong financial position to fund the proposed transaction of Aegidus. We plan to use approximately $300 million of our cash on hand and up to 300 million in debt supported by a new committed bridge financing facility with JPMorgan. Upon closing of the deal, which is expected in late 2 thousand 26 to early 2 thousand 27, expect trailing 12 month pro forma net leverage of approximately 2.7 times.

And while we expect the transaction to be dilutive to adjusted EBITDA and non GAAP EPS in year 1, driven by the initial launch phase of emcetate we then expect to deliver delever driven by both ongoing strength in our legacy business as well as emerging profitability resulting from the acquisition. In May, our board authorized a share repurchase program of up to $100 million. Year to date, we have repurchased 275 thousand shares for $20 million. At an average purchase price of approximately $72.54. Of this amount, $7.5 million was purchased as of the September 30 balance sheet date. Turning to slide 32. With 3 quarters of actuals in the books, we are updating our 2026 financial guidance ranges.

Our guidance outlined on Slide 32 is as follows. We expect 2026 total company net revenue of $1.085 billion to $1.125 billion, representing 25% year over year growth. We are revising our guidance for Cortrophin Gel net revenue to $480 million to $500 million to account for the reasons discussed by both Nikhil and Christopher this morning. We are also raising our ILUVIEN net revenue guidance to $80 million to $85 million based upon our improved outlook for the remainder of the year. We expect fourth quarter revenues from our generics and Other segment to be relatively similar to the third quarter revenues posted this morning.

Based on the strong profitability demonstrated over the first 9 months, we are raising adjusted non GAAP EBITDA to $290 million to $300 million. We are also raising our non GAAP earnings per share to be between $9.37 and $9.71 per share. We now expect adjusted gross margin to be in the range of 60.3% to 61%, based on favorable product mix, as I explained earlier. We anticipate between 21.5 million and 21.8 million shares outstanding for the purpose of calculating full year non GAAP diluted EPS and full year US GAAP effective tax rate of approximately 27% to 29%. With that, I will turn the call back to Nikhil.

Nikhil Lalwani: Thank you. Operator, could you please open it up for questions?

Operator: Yes. Certainly. We will now begin the Q&A session. To ask a question, you may press star then 1 on your telephone keypad. If you are using a speakerphone, pick up your handset before pressing the keys. If at any time you are requesting a question and you would like to withdraw it, please press star then 2. At this time, we will pause momentarily to assemble the roster. And today's first question comes from Vamil Divan with Guggenheim Securities.

Analyst: Great. Thank you for taking the questions. Congrats on the deal. You announced. So maybe if I could ask 1 question on the Cortrophin side and then 1 related to the acquisition. So on Cortrophin, I appreciate what you are saying around the delays in the revenue conversion. What I am trying to understand is if that did not take place and if revenue converted the way you expected, would you have reached the guidance that you had expected for the quarter and for the full year? Because we are following the prescription trends in IQVIA, looks like there is a little bit of slowdown there too.

So I am just trying to understand how much of it is volume versus more of this revenue conversion. And then on the acquisition, I am just-- not familiar with the company you acquired, so still learning it a little bit on the fly here. I am trying to understand the pricing side. It sounds like the price in The US will be sort of $900 thousand range. Also, seeing in Europe, it is $200 thousand. So I am trying to understand if you could talk about the commercial opportunity in U.S. versus ex-U.S. and then the sort of this difference in the pricing dynamics.

Is that any sort of issue given the current discussions around MFN, or would the pricing need to be adjusted in any way to reflect ex-U.S. pricing versus US? Thank you.

Nikhil Lalwani: Yep. Good morning, Vamil, and thank you for your questions. So your first question on the Cortrophin guidance revision. So as I said, importantly, we are seeing strong demand momentum Demand at the top of the funnel is strong across both existing specialties and the gout expansion. And As a reference, we said that the number of new cases initiated in the 5 months since the gout expansion in May is approximately 85 percent higher than the 5 preceding months. And so the answer to your question on you know, if we had not had the revenue conversion you know, dynamics that we have had, would we have achieved the Q3 guidance? Absolutely.

So we are just calibrating as we go forward. And, you know, Christopher spoke about the initiatives that we put in place. So there are. The updated guidance does not assume the full benefits of those efforts. And we have calibrated the impact of those efforts. Although we have seen early improvements already, right, in the time to therapy or time to first fill in late Q3, early Q4. And we also talked about, in Q4, in the existing specialties, we continue to have strong demand with the highest number of new cases initiated. Your second question regarding Aegidus pricing. Yeah. On that, with emcetate, Aegidus set the wholesaler acquisition cost for emcetate.

At $74 thousand per pack of 60 tablets. And based And based on their average daily dose of approximately 740 micrograms, observed in the TRIAC trial 1 and as described in The US prescribing information, that equates to the annualized wholesale acquisition cost of approximately $950 thousand. And you know, the pricing across The US and ex US takes into account that MCT 8 deficiency is an ultra rare condition. Over 1 thousand patients estimated in The US. Right? And many more patients outside The US. 1 in 70 thousand males is the expected or estimated incidence. Or prevalence And so emcetate price reflects the value it brings to patients in families who until now had no approved treatment option.

And MCT deficiency, as you know, is a severe life shortening disease for which there was no approved therapy with a median life expectancy of about 35 years. Approximately 30 percent of the patients dying in childhood the persistent thyrotoxicosis putting real strain on the heart and the body as Gary had outlined. So the label showed that the label showed that emcetate lowered elevated T3 levels and improved key markers of thyrotoxicosis, and the label covers patients of all ages they can be treated from diagnosis. And lastly, the pricing is in line with other ultra rare disease indications. Thank you, Vamil. Thank you.

Operator: The next question comes from Yuchen Ding with Jefferies.

Analyst: Hi, good morning. Thanks for taking our questions. I have several on the Aegidus acquisition. So you have 60 patients in the U.S. EAP program. So that already implies $60 million run rate, assuming, you know, the $950 thousand U.S. price? And how quickly can you convert the EAP to commercial drugs? And I also have some follow ups.

Nikhil Lalwani: Yeah. So as you correctly pointed out, that there are actually there are 60 patients on the EAP program. And there is 100 patients that the Aegidus team has genetically. Has identified and genetically validated. So our, you know, first priority is to ensure that the 60 EAP patients well-- first priority is to ensure coverage, right, as Christopher had laid out, and then to ensure that these 60 EAP patients are transitioning to the commercial drug program, then also that we are getting the additional patients that have been validated but not treated that they get on treatment. And ensuring, I think most importantly, the continuity of care Right?

For these patients that have been on the EAP program and also on, you know, global managed access program, right, as a reference. There are 300 patients that are globally across the managed access program and the EAP program in The US that are being treated with emcetate today. And then coming back to your sort of questions on implications for revenue, we look forward to sort of talking about the progress as the deal moves to close. And then we talk about 2027 performance. We are not giving 2027 revenue guidance at this time for MCT. Thank you. Got it.

And then as a follow-up, so pricing is certainly weight based in your $950 thousand estimate sort of reflects the 20 kilogram patient, and maybe that is around 3 to 4 years of age. But I am curious about the age distribution of the patients that are out there if there could be a focus on some, you know, sort of the older and heavier patients. And then finally, you know, I appreciate there are around hundreds of patients identified in The US, but how are you going to identify more if there is a registry in The US for this disease? Thanks so much. Sure. So on the focus look. We said that the median life age.

Median life age right now is 35 years. And so you know, there are 100 patients identified so far. there is over 1 thousand patients. That we that we believe that are there. We estimate in The US that have MCT deficiency. I will let Christopher talk about how when there is an available therapeutic, for rare. In a rare disease, then, you know, how the diagnosis expands. But on the age distribution which is your second question, you know, in terms of our focus, I think, look, we wanna get this treatment to all patients that are appropriate.

The earlier we can get it to the treatment to the patients that are you know, younger, like Gary talked about, the onset of symptoms early on and then the impact can be persistent. Right? So as much as we can get it to pediatric patients, but also to the adult patients, So our focus is to just get it to the appropriate patients. Right? In need. And then I will let Christopher touch upon the you know, the. How the. How efforts that Aegidus has already been making. it is really impressive what Aegidus team has already done patients, caregivers, and families, and the foundations. To increase the awareness.

But I will let Christopher talk about, you know, how that will expand the diagnose pool. Christopher?

Christopher K. Mutz: Yeah. Thanks, Nikhil, and thanks for the question. I think there is a huge opportunity now to just really invest in significant disease education first of all. I think oftentimes, you know, it is our expectation, I think and I think the Aegidus team as well that these patients are being seen by, pediatric neurologists, pediatric endocrinologists, maybe even medical geneticists, but people are not contemplating a diagnosis of MCT8, 1, because as Gary said, it is a newer disease entity, but 2, because, you know, there is no FDA approved treatment, right?

So I think really, really emphasizing and investing in disease education in the appropriate specialties where we think these kids and these patients are going to be showing up, is going to be kind of first and foremost. I think the other piece is, you know, there are advanced analytics now using claims data. And, triangulating claims data, with specific patient populations that have-- we think are going to be enriched for potentially misdiagnosed patients. So patients that actually do have MCT but are now being diagnosed as, maybe, cerebral palsy. For example, and those are patients that, you know, I think just as an example where we would focus our efforts as well.

But really, it is about disease education. it is about ensuring that physicians now know there is an FDA approved treatment and that you know, there is a real reason and a call to action for testing, right, these patients.

Nikhil Lalwani: Perfect. Thanks so much. Thank you.

Operator: Thank you. And the next question comes from David Amsellem with Piper Sandler.

Analyst: Hi. This is Nikhila on for David. Thank you for taking our question. First, regarding the bottlenecks in the specialty pharmacy network, how long do you expect these to persist, and can you quantify how much Cortrophin business you have lost? Or how much demand has not been converted to business due to the constraints at the moment? that is number 1. And number 2 on the payer access front, as the ACTH category continues to grow, can you speak to how access dynamics may evolve here? Thank you.

Nikhil Lalwani: Yeah. Morning, and thank you for your questions. So on the specialty pharmacy I think that what I would say is the demand generation was very significant. Right? With an 85% increase in the number of new cases initiated over the previous 5 months. Right, in the last 5 months over the previous 5 months. And that put pressure on our specialty pharmacy network We have already done a number of things. Right? We have strengthened the support and collaboration at the existing specialty pharmacies. Also expanded our specialty pharmacy network to service the regional areas of especially high demand. Right? And we are actively evaluating further expansion to support the future growth in 2027.

And so we are starting to see the impact of that right, already with the with the conversion to. Of revenue patients to therapy. Right? Of. And you can see that in the earlier time to fill that we are seeing for patients in the latter part of Q3 and the early part of Q4. In addition to the specialty pharmacy network, we have also expanded our patient support team to further support the primary care and podiatry that are naive to ACTH, And our team is providing them with resources to navigate the enrollment to fulfillment process.

So both these efforts, right, or sets of initiatives are having significant impact on the improvement of the revenue conversion, and we will continue to see the impact of that into the rest of Q4 and beyond. And then your second question on ACTH category. Right? There is no significant change in the access Right? We continue to work on the improved access for the ACTH category. As you can see in the growth of the overall category between us and our competitor, that, you know, more appropriate patients in need are getting the needed ACTH. Therapy. And, you know, we look forward to continuing to work on improving the access for ACTH therapy. Thank you for your questions.

Thank you.

Operator: And the next question comes from Ekaterina Knyazkova of JPMorgan.

Katerina: Thanks so much. So 2 quick questions on Cortrophin Gel. Can you just talk a little bit more about the feedback you have been getting on the gout rollout and the response you are seeing from PCPs? Kind of putting aside the pharmacy bottleneck piece just how is underlying demand coming in versus your expectations? And then second part is, so now that some PCPs are using the product, is there an opportunity to get them to use the product in other indications as well? And what could that opportunity look like? Thank you.

Nikhil Lalwani: Sure. Good morning, Ekaterina, and thank you for your question. So the demand generation in gout has been very strong. Right? both in depth and breadth. In Q3, the depth of the breadth of prescribing expanded with a 67% increase in the number of prescribers. Right? So more prescribers. And remember, this community of prescribers is largely naive to ACTH. So these are all prescribers that are using ACTH for the first time. So there is a 67% increase in the prescribers quarter on quarter, right, versus the second quarter. Second, we saw the increased depth of prescribing.

Now with 40% of our prescribers, across primary care and podiatry initiating 2 or more cases, And overall, this translated into demand much higher demand with the doubling of the number of new cases initiated in Q3 versus Q2. So the demand is very strong. For. In the in the gout expansion. And then you brought up an interesting second point, which is when you go into primary care. When our when our reps are going into the primary care and podiatry offices, they begin the conversation with gout. But sometimes the conversation also goes into other indications that Cortrophin is indicated for.

Of course, it is know, it is focused on what is in the label, and we are seeing utilization of ACTH for other indications that Cortrophin is currently indicated for. As we make progress in that area, we will we will update you on the progress. Thank you, Ekaterina. Thanks.

Operator: Thank you. Next question comes from Gary Nachman with Canaccord Genuity.

Gary Nachman: Thanks. Good morning. So first on Cortrophin. So on the specialty pharmacy network dynamic, I am curious if that bottleneck could have been anticipated at all. Based on your initial expectations for growth in demand, particularly from gout. So how surprised you were by this dynamic And will you be revisiting the extent of the primary care and podiatry expansion at all if it becomes more challenging in that space. And then I have 1 on emcetate.

Nikhil Lalwani: Sure. Good morning, Gary, and thank you for your questions. Look, the specialty pharmacy network, we had you know, we had anticipated that there will be a significant. We obviously knew that there would be an expected increase in demand. Demand generation. The demand generation was significantly in excess of what we had originally anticipated. And also, you know, the issue is also impacted by the fact that you know, the prescribers-- the podiatrists and primary care physicians-- are new and they are ramping up their capabilities in the Cortrophin enrollment to fulfillment process. So both these dynamics together is what caused the revenue conversion dynamic that we have seen. We had invested in additional patient support services.

We had also invested in additional expansion of our specialty pharmacy network. But this those, we still saw bottlenecks in revenue conversion. And we are investing more. We are adding more resources in patient support and expanding our specialty pharmacy network to deal with the significantly higher demand. And look, you know, we obviously understand the issues with the adjustment in the guidance. However, you know, the demand generation is very strong and the conversion of patients to therapy, it is a question of when, not if. That brings me to the second question, We think the gout expansion has been successful.

And that we need to keep-- and we are investing in operational initiatives to keep improving the conversion to patients on therapy. So, you know, I think your question also went into, are you considering other expansions at this point Not really. At this point, we are focused on, you know, closing out 26. By getting these operational initiatives to deliver the Q4 Cortrophin guidance. And continue with momentum into 2027. And obviously closing the Aegidus acquisition. Back to you, Gary.

Gary Nachman: Yep. Okay. Yeah. The latter part of the question was really more just if you would reconsider the extent of the expansion that you did in primary care and podiatry if you know, that ends up being a more challenging space.

Nikhil Lalwani: But, you know, maybe that is just gonna take a little bit more time. No. I. We do not think that we would reconsider the extent of expansion. Okay. In fact, the success we are seeing right, and the question that Ekaterina asked earlier about potential you know, or usage even beyond gout at these offices. Makes us think about not now, but at some point in the future, Right? When, you know, when we have continued to make progress, think about, you know, we are only reaching a handful of primary care physicians and podiatrists. Right? But you know, several moons down, there is a huge opportunity. I mean, listen.

The ACTH market, Gary, as we have as we have outlined, right, is the addressable patient population is much, much larger than anything that we are addressing today between us and the competitor. And we feel confident that nothing has changed regarding the significant opportunity for appropriate patients with ACTH. But with treatment to get treatment through ACTH. Thank you, Gary.

Gary Nachman: Okay. Alright. that is helpful. Yeah. And then just on MCT. So you know, when considering the net valuation, of the deal at around $430 million, just what is the time to peak of the $300 million for the product? So what is what is factored in there? It implies about 1 thousand patients based on the pricing that you said over time. And there is only a thousand plus in The US. So how much will ex US contribute to that? And then just also, what is the administration like? For Entity? So how easy is it to treat these patients once you identify them at those concentrated sites? And how long do they typically stay on drug?

Is it indefinitely? Thanks.

Nikhil Lalwani: Sure. So I will take the first question. Which is you know, we will advise you on the progress that we are making on the. On MCT revenues as we as the deal closes and we move forward. At this time, we are not giving a time to peak sales. Right? The drug was approved a few weeks ago and we are obviously. as Christopher highlighted, it is tremendous that the Aegidus team already has 100 patients that have been validated but untreated. Oh, sorry. 60 of whom are on the EAP. And there is over 100 that are validated but untreated in aggregate.

So my point is that and, you know, as the as the disease awareness expands, the number of diagnosed patients and then we will treat those patients. We will talk about the trajectory and the ramp as we make that progress. I will let Christopher answer your question on the administration. That happens at home for these patients. And, you know, and the time that they stay on therapy. Christopher?

Christopher K. Mutz: Yeah. Sure. I think that is 1 of the-- when you think about this disabled disease population and the care that these patients need, I think the fact that this is this is a tablet, right, and that patients do not have to travel for infusions, is a real advantage. And so we have heard that from the Aegidus team. And so patients are able to take this orally as a tablet. it is also available to be liquefied. So if there is a g tube being used, it is it is able to be provided through a g tube and kind of in a liquid form as well. And patients stay on therapy Yeah.

Nikhil Lalwani: And, Gary, your. The second part of your question, patients stay on therapy throughout their life. So this is taken daily. 1, you know, based on their weight, dosing-- the dosing it is a scored tablet. So the dosing is adjusted based on the age. Sorry. The weight of the patient. Mhmm. Okay. Thanks. Thank you.

Operator: And the next question comes from Daniel Krizay with Leerink Partners.

Daniel: Great. Thank you. Thank you. Good morning. Just wanted to ask sort of the increase in demand that you are seeing in gout. Is that coming from, you know, more docs that are choosing to use Cortrophin Gel? Or is it more that they are using it more to treat more flares on a per prescriber basis? Just anything you could share there would be super helpful. Thank you.

Nikhil Lalwani: Yes. Good morning and thank you for your question, Daniel. I think that if I understood your question correctly, it is being used for acute gouty arthritis flares. So this is to deal with the exacerbations that come when the patients have these flares. it is used to treat the exacerbations, and it is you know, when other treatment options are. So it is a late line therapy that is being used when other treatment options are not working for that patient because it has a different mechanism of action. So hope that answers your question, Daniel.

Daniel: Maybe I will try to refine it here in the fall. Like, when we think about the expansion into primary care and podiatry, and, obviously, led to a lot more demand than you anticipated. Is that because you are seeing more doctors sign up to use the therapy, or are they just using it to treat more patients than you anticipated?

Nikhil Lalwani: And I can explain it well, I will I will start with-- got it. Sorry. Yeah. No. I understand your question, Daniel. So you know, we will start with the. From the about 10 million patients that have gout, believe the addressable market for acute gouty arthritis flares is about 285 thousand patients. And we have been you know, serving a very. The. that is significantly underpenetrated So our expansion into primary care and podiatry was to reach more patients Right? And almost all of these private care physicians and podiatrists are naive to ACTH. So they have not been using ACTH before.

And so what is happened with this expansion is we are able to reach more patients through these new prescribers. Right? More than half of prescribers overall for Cortrophin are folks that have. Are prescribers that have never used. That were naive to ACTH, and that number is only going to grow and has grown with this gout expansion. Right? Even within this gout expansion quarter on quarter, we talked about there is a 67% growth in the number of new prescribers between Q3 versus Q2. So the increased demand is coming from reaching new prescribers and therefore reaching more patients in that large addressable patient population that is significantly under penetrated. Very helpful. Thank you. Thanks. Thank you, Daniel.

Operator: Thank you. And the last question from Brandon Folkes with H. C. Wainwright.

Brandon Folkes: Hi. Thanks for taking my question. I want to just follow-up on the Cortrophin specialty pharmacy comments. You know, can you just elaborate on that? You know? What is the demand you saw in gout contemplated in your initial 2026 guidance? It would seem so. if we look at kind of the revenue pull through now.

So can you just help us think about is gout actually a much bigger part of the pie today than perhaps you had thought of in your initial 26 guidance, and then the other side of that is, you know, how are the legacy indications holding up And then maybe you know, along those lines, you know, there is been a few external factors in 2026 on core Cortrophin. Can you just elaborate on the internal levers you have to pull in terms of 2027? And how you limit the external factors as well in 2027.

Nikhil Lalwani: Sure. Good morning, Brandon, and thank you for your questions. Look, we have strength across both the existing specialties as well as the gout expansion. The existing specialties continue to have strong demand across indications, right, across the core indications that we have in neurology, nephrology, rheumatology, and also in ophthalmology and pulmonology and they have. Those existing specialists continue to have strong momentum And the data point we shared is that momentum has continued into October, with the highest number of new cases initiated. Gout, the demand trends are stronger than we had anticipated at the time of launch. Right? Having said that, the revenue conversion is at this time lower than what we had originally anticipated.

So gout is not a bigger part of the pie than when we had originally anticipated in the initial guidance. Right? Having said that, again, we have very strong demand generation in terms of revenue conversion. it is a question of when, not if. And then very importantly, which goes into the. Your third question, we are already taken steps there and are beginning to see the impact of the initiatives. Both on the specialty pharmacy network capacity as well as on the expansion of our patient support. To support the learning curve of the gout PCPs and podiatrists that are newer to the to the Cortrophin enrollment to fulfillment process.

And then if you zoom out and say going into 2027, you know, the. We have already activated a number of different levers. You know, to support the significant strong growth going into 2027. Right? So starting from Q1, right, we are. Well, this year, we have this issue with insurance reverifications. We obviously learned from that. We benchmarked how companies much bigger than us deal with insurance reverifications with 5x, 10x the volumes. We have added dedicated resources, we have strengthened our patient support systems, our CRM, Right? So that is already in motion. So you know, in Q1, those. That internal lever has already been pulled. Those dedicated resources are already working through the reverifications.

That are that are gonna be coming up for Q1. And then to support the demand generation, right, we are expanded. We have. We already expanded the patient support the specialty pharmacy network. When we did the gout expansion, but we have done it even more. Right? We have seen that was not enough, and we have expanded it even more both the specialty pharmacy network capacity as well as the patient support and the field reimbursement that supports the conversion to therapy. Thank you, Brandon.

Brandon Folkes: Great. Thanks very much. May I ask 1 just on the acquisition, obviously, congratulations on that. You know, to get to the peak sales figure, you know, we assume an expansion of the currently diagnosed patients. You know? So can you just elaborate on what the challenge has been in getting patients diagnosed in this indication? And do you have a sense of where those patients are receiving treatment, the undiagnosed patients, where they are getting treatment today? Thank you.

Nikhil Lalwani: Yeah. So as with most ultra rare conditions, there is, you know, there is. When there is no treatment available, diagnosis rate tends to be lower as there is greater awareness and, you know, there is significant efforts being made by the patients, by the caregivers, by the foundation, and many-- there is-- And by the Aegidus team. Right? It is truly impressive what the Aegidus team has done. Right, with increasing the awareness, obviously, by developing this therapy, Right? And there is over 300 patients across the globe that are being treated with emcetate even today. And you know, you are seeing the impact of their efforts even in Germany, right?

Where within the course of a year, they have doubled the number of patients diagnosed you know, versus when they launched after approval in February 2025. So a number of different initiatives, Christopher spoke to some of them. We will come together to both support to increase the awareness and support the diagnosis of the appropriate patients. And we have seen this, when you look at analogs, of ultra rare indications, you see this time and again.

That as awareness of the disease increases, when there is an available therapeutic, you know, you realize that there are a lot more patients that can benefit from this therapy because there is an awareness of the of the disease and of an available therapeutic to the patients and caregivers. And you know, at the end of the day, that is what is most important. Right? Getting this therapy, right, the first and only approved therapy for this debilitating condition of MCT8 deficiency. And that is what we will be focused on. Thank you, Brandon. Right. Thank you very much.

Operator: Thank you. This concludes our Q&A session. I will turn the conference back over to Nikhil Lalwani for any closing comments.

Nikhil Lalwani: Thank you, Keith. Turning to Slide 34. In closing, we are making progress on the transformation into a leading rare disease company. The offer to acquire Aegidus Therapeutics represents a compelling opportunity to bring a first in class therapy to a profoundly underserved patient population while enhancing our future growth and profitability profile. We have taken swift action to improve our performance with Cortrophin Gel, and remain confident in the multi year growth opportunity. We also continue executing in generics, and we have been deploying capital in a disciplined manner to create shareholder value. Through the remainder of the year, we are focused on executing our strategic priorities achieving our 2026 financial guidance, and positioning ANI for long term growth.

Thank you everybody for joining us. Thank you, operator.

Operator: Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect your lines.

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