Cuộc gọi công bố kết quả kinh doanh quý 3/2026 của ANI Pharmaceuticals (ANIP): Hạ định hướng Cortrophin, nâng triển vọng EBITDA

Những điểm nhấn chính

• ANI Pharmaceuticals ghi nhận doanh thu thuần quý 3/2026 đạt 290,8 triệu USD, tăng 28% so với cùng kỳ năm trước, trong khi EBITDA điều chỉnh (non-GAAP) tăng 40% lên 83,3 triệu USD.
• Doanh thu Cortrophin Gel tăng 36% lên 138,7 triệu USD nhưng thấp hơn kỳ vọng của ban lãnh đạo do các hạn chế về công suất của hệ thống nhà thuốc chuyên khoa cùng thời gian tiếp nhận kéo dài đã làm chậm tiến độ xử lý đơn thuốc.
• ANI đã hạ dự báo doanh thu Cortrophin Gel năm 2026 xuống 480 - 500 triệu USD từ mức 520 - 540 triệu USD trước đó. Tại điểm giữa của khung dự báo điều chỉnh, doanh thu vẫn sẽ tăng trưởng hơn 40% so với cùng kỳ năm trước.
• Công ty đã nâng dự báo EBITDA điều chỉnh (non-GAAP) năm 2026 lên 290 - 300 triệu USD và dự báo EPS điều chỉnh (non-GAAP) lên 9,37 - 9,71 USD.
• ANI đã công bố kế hoạch chào mua toàn bộ bằng tiền mặt đối với Egetis Therapeutics với giá trị vốn cổ phần là 560 triệu USD. Giao dịch này sẽ bổ sung Emcitate, liệu pháp đầu tiên và duy nhất được phê duyệt tại Mỹ và EU để điều trị nhiễm độc giáp ngoại biên liên quan đến thiếu hụt MCT8.
• Ban lãnh đạo cho biết thương vụ mua lại dự kiến sẽ làm pha loãng EPS điều chỉnh (non-GAAP) trong năm đầu tiên do chi phí đầu tư cho việc ra mắt tại Mỹ. Tỷ lệ đòn bẩy ròng danh nghĩa (pro forma) dự kiến vào khoảng 2,7 lần tại thời điểm hoàn tất giao dịch.

Dữ liệu tài chính cốt lõi

ANI kết thúc quý với 420,8 triệu USD tiền mặt không bị hạn chế sử dụng và 616,9 triệu USD nợ gốc. Tỷ lệ đòn bẩy ròng đạt 0,7 lần so với EBITDA điều chỉnh (non-GAAP) trượt 12 tháng là 283,2 triệu USD.

Kết quả kinh doanh và hoạt động

Nhu cầu Cortrophin vẫn duy trì mạnh mẽ nhưng tiến độ xử lý đơn thuốc chậm lại

Ban lãnh đạo cho rằng việc chuyển hóa doanh thu từ Cortrophin yếu hơn kỳ vọng xuất phát từ hai hạn chế trong khâu vận hành.

Thứ nhất, số lượng bệnh nhân mới tăng mạnh sau khi mở rộng sang điều trị bệnh gút. Số ca điều trị được khởi tạo trong 5 tháng sau đợt ra mắt vào tháng 5 cao hơn khoảng 85% so với 5 tháng trước đó, gây áp lực lên công suất của hệ thống nhà thuốc chuyên khoa ở cả mảng bệnh gút lẫn các chuyên khoa hiện hữu.

Thứ hai, các phòng khám đa khoa ban đầu và chuyên khoa bàn chân nhìn chung còn mới mẻ với liệu pháp ACTH, do đó cần được hỗ trợ nhiều hơn trong việc tiếp nhận bệnh nhân, thủ tục bồi hoàn bảo hiểm và giao nhận thuốc. Điều này đã kéo dài khoảng thời gian từ lúc khởi tạo ca bệnh cho đến khi bệnh nhân bắt đầu quá trình điều trị.

Các chỉ số cơ bản đối với mảng bệnh gút vẫn rất khả quan. Số lượng bác sĩ kê đơn tăng 67% so với quý trước, 40% bác sĩ kê đơn thuộc chuyên khoa đa khoa ban đầu và bàn chân đã khởi tạo ít nhất 2 ca bệnh, và tổng số ca bệnh gút mới đã tăng gấp đôi so với quý 2.

ANI đã mở rộng mạng lưới nhà thuốc chuyên khoa, gia tăng nguồn lực hỗ trợ bệnh nhân và tăng cường hợp tác với các nhà thuốc hiện có. Ban lãnh đạo ghi nhận sự cải thiện khiêm tốn về thời gian cấp phát đơn đầu tiên vào cuối quý 3 và đầu quý 4, đồng thời sản lượng tháng 10 đạt mức kỷ lục ở các chuyên khoa hiện hữu.

ILUVIEN và thuốc generic hỗ trợ chiến lược đa dạng hóa

ILUVIEN mang lại 22,3 triệu USD doanh thu trong quý 3, tăng 34%. ANI dự kiến sử dụng kết quả từ nghiên cứu Synchronicity giai đoạn IV để tăng cường tiếp cận với các bác sĩ chuyên khoa võng mạc đang điều trị viêm màng bồ đào phân đoạn sau mạn tính không do nhiễm trùng.

Doanh thu thuốc generic đạt 104,5 triệu USD, tăng 11%. ANI đã ra mắt 16 sản phẩm generic từ đầu năm đến nay và cho biết công ty tiếp tục duy trì vị trí thứ hai về tổng số hồ sơ nộp và được phê duyệt liệu pháp generic cạnh tranh.

Thương vụ mua lại Emcitate giúp mở rộng danh mục thuốc điều trị bệnh hiếm

ANI đã đưa ra đề nghị mua lại Egetis Therapeutics với giá 560 triệu USD tiền mặt. Ban lãnh đạo ước tính giá trị doanh nghiệp vào khoảng 434 triệu USD sau khi tính đến 95 triệu USD tiền mặt mà Egetis đã đồng ý nhận từ việc bán phiếu đánh giá ưu tiên cho bệnh nhi hiếm gặp.

Giao dịch dự kiến sẽ được tài trợ bằng khoảng 300 triệu USD tiền mặt hiện có và tối đa 300 triệu USD nợ vay được hỗ trợ bởi khoản tín dụng bắc cầu đã cam kết từ J.P. Morgan. Giao dịch dự kiến sẽ hoàn tất vào cuối năm 2026 hoặc đầu năm 2027, tùy thuộc vào các điều kiện thông thường.

Emcitate đã được EU phê duyệt vào tháng 2/2025 và được Mỹ phê duyệt vào tháng 9/2026. Thuốc bắt đầu được thương mại hóa tại Mỹ vào ngày 27/10/2026. ANI ước tính có hơn 1.000 người tại Mỹ mắc chứng thiếu hụt MCT8. Hơn 100 bệnh nhân tại Mỹ đã được xác nhận bằng xét nghiệm di truyền, trong đó có khoảng 60 bệnh nhân đang tiếp nhận Emcitate thông qua chương trình mở rộng quyền tiếp cận thuốc.

Ban lãnh đạo ước tính Emcitate có thể đạt doanh số đỉnh điểm hàng năm hơn 300 triệu USD cho chỉ định đã được phê duyệt, nhưng chưa đưa ra mốc thời gian cụ thể để đạt mức đỉnh này. Sản phẩm được hưởng quy chế độc quyền thuốc hiếm tại Mỹ và EU cùng một bằng sáng chế đã đăng ký có hiệu lực kéo dài đến giữa năm 2045.

Dự báo của ban lãnh đạo

Ban lãnh đạo dự kiến doanh thu quý 4 từ thuốc generic và các sản phẩm khác sẽ tương đối tương đương với quý 3. Dự báo điều chỉnh cho Cortrophin đã tính đến sự cải thiện kỳ vọng từ các sáng kiến vận hành, nhưng chưa tính đến toàn bộ lợi ích từ các sáng kiến này.

Rủi ro và các yếu tố cần theo dõi

• Tăng trưởng số ca điều trị Cortrophin đã vượt quá công suất của mạng lưới nhà thuốc chuyên khoa của ANI, làm chậm trễ quy trình xử lý bồi hoàn bảo hiểm và thời gian bắt đầu điều trị.
• Các phòng khám đa khoa ban đầu và chuyên khoa bàn chân cần được hỗ trợ nhiều hơn so với các phòng khám chuyên khoa khác trong việc tiếp nhận bệnh nhân và giao nhận Cortrophin.
• Công ty đã hạ triển vọng cả năm của Cortrophin bất chấp các chỉ số nhu cầu vẫn mạnh mẽ, khiến tỷ lệ chuyển hóa giao nhận thành công trở thành thước đo thực thi then chốt cho quý 4 và năm 2027.
• Thương vụ mua lại dự kiến sẽ làm tăng tỷ lệ đòn bẩy ròng danh nghĩa lên khoảng 2,7 lần và dự kiến sẽ làm pha loãng EPS điều chỉnh (non-GAAP) trong năm đầu tiên.
• Đà tăng trưởng thương mại của Emcitate phụ thuộc vào phạm vi chi trả của bảo hiểm, việc chuyển đổi các bệnh nhân thuộc chương trình mở rộng tiếp cận và việc chẩn đoán thêm các bệnh nhân thiếu hụt MCT8.

Điểm nhấn phiên hỏi đáp với các nhà phân tích

Các nhà phân tích tập trung nhiều vào việc liệu việc hạ dự báo Cortrophin phản ánh nhu cầu suy yếu hay do sự chậm trễ trong khâu chuyển hóa đơn thuốc. Ban lãnh đạo khẳng định nhu cầu vẫn duy trì mạnh mẽ và cho biết nếu không gặp các hạn chế trong khâu xử lý đơn thuốc, ANI đã đạt được kỳ vọng trước đó trong quý 3. Công ty xem vấn đề chuyển hóa chỉ mang tính thời điểm, đồng thời thừa nhận rằng các nỗ lực cải thiện vận hành sẽ cần thời gian để phát huy toàn bộ hiệu quả.

Về mảng bệnh gút, ban lãnh đạo cho biết nhu cầu tăng cao chủ yếu nhờ các bác sĩ kê đơn mới tiếp cận được những bệnh nhân trước đây chưa từng được điều trị. ANI không có kế hoạch thu hẹp nỗ lực mở rộng ở các phòng khám đa khoa ban đầu và chuyên khoa bàn chân, đồng thời tiếp tục nhận định thị trường ACTH vẫn còn mức độ thâm nhập rất thấp.

Các câu hỏi về Emcitate xoay quanh định giá, việc xác định bệnh nhân và đà tăng trưởng thương mại. Ban lãnh đạo viện dẫn chi phí mua buôn hàng năm (WAC) tại Mỹ vào khoảng 950.000 USD dựa trên liều dùng trung bình hàng ngày ghi nhận trong các nghiên cứu lâm sàng. Công ty dự định ưu tiên khả năng tiếp cận bảo hiểm chi trả, chuyển đổi khoảng 60 bệnh nhân thuộc chương trình mở rộng tiếp cận tại Mỹ sang liệu pháp thương mại và tăng cường chẩn đoán thông qua đào tạo y khoa cho bác sĩ và phân tích dữ liệu.

ANI không đưa ra dự báo doanh thu năm 2027 cho Emcitate cũng như mốc thời gian để đạt tiềm năng doanh số đỉnh điểm ước tính của sản phẩm. Ban lãnh đạo cho biết Emcitate được dùng hàng ngày theo liều lượng dựa trên cân nặng, và có thể dùng dưới dạng viên nén hoặc dạng lỏng qua ống thông dạ dày (G-tube).

Toàn văn biên bản cuộc gọi công bố kết quả kinh doanh

Toàn văn cuộc gọi công bố kết quả kinh doanh

Phần trình bày của ban lãnh đạo

Operator

I think this should be start. Sorry, thank you. Good day, everyone, and welcome to today's ANI Pharmaceuticals, Inc. Third Quarter 2026 Earnings Results Conference Call. Please note this event is being recorded. After the speaker's prepared remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press the star key followed by one on your telephone keypad. would like to withdraw your question please press star then number two on your telephone keypad Now my pleasure to turn the conference over to Irina Koffler.

Unknown Speaker

Thank you, Keith. Welcome to ANI Pharmaceuticals' third quarter 2026 earnings results call. This is Irina 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, Chris Mutz, Senior Vice President head of ANI's rare disease business, and Mary Pao, chief medical officer. Earlier this morning, on November 5, 2026, we released our results for the third quarter 2026 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 Aegida Therapeutics, which ANI announced this morning. Please refer to the transaction website at www.biopharma-offer.com and the 8K filed by ANI this morning. further information about the offer, including important considerations for holders of Aegida 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 one 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 Aegis Therapeutics. Mary will dive into more detail on MCT8 deficiency and MCT8's mechanism of action. Chris will discuss the commercial opportunity for MCAT and will also provide an update on our rare disease business.

Lastly, Steve will discuss our Q3 financial results and 2026 guidance. And with that, I'll 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 seven. At the start of 2026, we set out three 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 Alimera 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 eight, for the third quarter, we generated 290.8 million of total revenues 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 growth in generics up 11% year over year. Moving to slide nine. While we delivered strong overall results on the top and bottom line, I want to address our Cortrophin performance. We've been clear that our goal for Cortrophin is to maximize its multi-year 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, Cortofin gel net revenues came in lighter than we expected when we outlined guidance last quarter at 138.7 million. This was primarily driven by two factors. First, for the gout expansion team, we had strong demand generation in the third quarter with a large funnel of new patient cases, which doubled compared to the second 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 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. Chris 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 fulfill 480 million to 500 million compared to 520 to 540 million previously. Importantly, this represents year-over-year growth of over 40% at the midpoint on this revised guidance range. And nothing we have seen changes our conviction in the gout opportunity or in the strong multi-year growth potential of cotrophin across the board. 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 three 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 outpouring performance 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 two 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, discipline 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 Alimera Sciences.

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 near 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 and 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 EGIDIS into ANI, our commitment is to honor that work to ensure that the patients and 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 growth driver, Emcitate. Emcitate is the first and only approved treatment in the EU and US for peripheral thyrotoxicosis associated with MCT8 deficiency. is a rare disease, impacting more than 1,000 patients in the US alone, and 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 Empsitate'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 five years with Cotrofen. and Illuvien. We believe we can leverage our resources and capabilities to maximize the reach and impact of MCITATE in one 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 MCITATE 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, MCITATE represents an ideal product to add to our portfolio. Mary will speak to the disease in more detail shortly. MCITATE was approved in Europe in February, 2025 and in the US in September, 2026. MCITATE became commercially available in the US last week on October 27th. We estimate that approximately one in 70,000 males are impacted by MCT8 deficiency globally. Today, more than 100 US patients have been genetically confirmed and approximately 60 US patients are already receiving MCT8 through an expanded access program or 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. MCT8 has durable growth runway supported by new chemical entity exclusivity, orphan drug exclusivity in both the US and the EU, and 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 MCITATE, and we are pleased with the unanimous support we have received from the Aegis Board of Directors and significant shareholders controlling approximately 42% of shares. Slide 13 outlines the financial terms. We are offering to acquire EGITAS 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 EGDIS 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 backstopped by new committed bridge financing facility from J.P. Morgan. Upon closing of the deal, we expect trailing 12-month pro forma net leverage to be approximately 2.7x. From a financial perspective, the deal enhances our growth profile.

With MCIT 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 dilutive to adjusted non-GAAP EPS in year one, 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. With that, I'll turn the call over to Dr. Mary Powell, our Chief Medical Officer, to provide an overview of MCT8 deficiency. Mary?.

Unknown Speaker

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

Because it's located on the X chromosome, it's X linked and in fact, almost entirely males, and as and with an estimated birth incidence of approximately 1 in 70,000 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 high hypothyroid in the CNS and hyperthyroid in the periphery. When these patients don't have a functioning MCT8 transporter, the active thyroid hormone T3 cannot enter specific target cells. And in the brain, this leaves the brain deprived of thyroid hormone. However, in the peripheral tissue, tissues, T3 is able to enter those tissues through other transporters.

It's not MCT8 reliant and therefore circulating T3 levels are high. In the brain, the brain keeps sensing that there is no T3 and keeps making more T3 to get to the brain, but that T3 is only becoming toxic in the periphery. This persistent thyrotoxicosis in the periphery causes damage in tissues such as heart and muscle. So these symptoms of MCT-8 start very early and become noticeable often at three to six months of age when children begin to miss normal developmental milestones. Delay in diagnosis means that they're typically diagnosed around age two, and these thyroid hormone lab tests show a characteristic pattern of elevated T3, and then that can be confirmed by genetic testing of MCT8. This is a very severe life-shortening condition that's characterized by profound intellectual disability. physical disabilities that are compounded across different organ systems requiring lifelong chronic 24-hour often care. The median life expectancy is about 35 years, and as many as 30% 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 estimate that there are more than 1,000 people living with the MCT8 deficiency in the U.S. 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 MCT8K. So, turning to slide 16, we're going to talk a little bit about the profound intellectual and physical disabilities that come with MCT deficiency. There's extreme burden to the patients and caretakers. for MCT8 deficiency. On the left, you'll 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 temperature body tone, dystonia, and spasticity. Most patients are unable to sit or walk independently, and many are unable to swallow because they don't have the coordination of those muscles. If you look on the right, you'll 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 infections secondary to aspiration because they're not able to swallow, and a hypermetabolic state. which ultimately leads to failure to thrive when patients have low body weight, poor heat tolerance, and also increased perspiration. This failure to gain weight is associated with a poor prognosis and an increased death in this patient population. This peripheral thyrotoxicosis is a central driver of morbidity in this disease state. On slide 17, we'll take a look at the mechanism of action, which I briefly went through earlier.

Emcitate is a small molecule thyroid hormone receptor agonist. What's 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 8, we can show that MCITATE's FDA approval was supported by robust clinical evidence, and there are two key studies that were involved. First is called Triac, and this was a 30-day randomized double-blind placebo-controlled withdrawal study. So patients who were already taking MCITATE were randomized either to continue treatment or to switch to placebo.

In the patients switched to placebo, total T3 thyroid hormone rose about one and a half times faster than in those patients who continued on the MCITATE therapy. Half of the patients on placebo, four out of eight patients, needed rescue because their T3 then rose above the normal range compared to with only one of seven who were receiving. MCITATE THERAPY. EVERY PATIENT SWITCHED TO PLACEBO HAD A LARGER INCREASE IN T3 THAN ANY PATIENT WHO RECEIVED MCITATE. Excuse me. The second set of evidence comes from the TRIAC trial one, which was a 12 month open label study. So in this study, mean total T3 fell from 323 to 118 nanograms per deciliter, which is a highly significant reduction in T3. Key clinical markers of fire. thyrotoxicosis also improved, including systolic blood pressure and heart rate, with both decreased. And importantly, body weight for age also increased.

In slide 19, we'll see that there are other three independent sources of real-world evidence which also support these clinical trials. They are not included in the U.S. prescribing information. These three studies include the Erasmus Medical Center cohort study, which followed patients for up to six years and examined the effect of Emcitate on T3 as well as clinical markers of thyrotoxicosis. There's the EMC survival study, which examined treated versus untreated patients in a cohort of more than 600 individuals, which is by far the largest. the largest MCT8 patient cohort to be ever studied. This real world retrospective study compared treated versus untreated patients based on survival, and we expect the findings of these studies to be published by the Erasmus Medical Center in the future. 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 Chris Mutz to discuss our planned commercial strategy for MCITATE. Chris?.

Christopher Mutz

Thank you, Mary, and good morning, everyone. I'll 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. of us on ANI's commercial team came from Alexion, where we focus 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 MCITATE launch, and we are excited to join our colleagues at Agios to begin engaging with this physician community, as well as the patients and families whose lives have been so profoundly impacted by MCT8 deficiency. As part of the transaction, we would be acquiring the established EGITIS 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 MCIT-8. It is a real testament to the team at EGITIS that as of today, nearly 300 patients around the world are being treated with MCITATE when you combine the U.S. Expanded Access Program with the Global Managed Access Program. Our first commitment is ensuring these patients, their families, and caregivers have our support to continue MCITATE treatment.

Turning to slide 22, MCITATE was approved in Europe in February 2025 and by the FDA on September 28, 2026 as the first and only therapy for MCT-8 deficiency. From a commercial standpoint, two key features stand out. First, the label is broad. Emcitate 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. MCT8 enters a category where there are no FDA-approved alternatives and has durable patent protection into mid-2045. This exclusivity gives a significant runway to invest in commercial operations to bring this important therapy to more patients in need. Commercial product is already available in the U.S., and Egetis 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 1,000 patients who are living with MCTH deficiency in the U.S., over 100 have been diagnosed and validated by the EGDS 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 MCTH. 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% managed across just six 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 EGID 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 24, this launch brings together complementary strengths. Aegis has built a dedicated U.S. launch team with commercial and medical affairs employees already hired and onboarded, including key account managers and regional medical directors in each territory. ANI plans to supplement this team with our additional resources and scale to drive higher of MCT8 deficiency and the new availability of an FDA-approved treatment. Aegidus has already established a patient support program with Panther RxRare, 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 MCT8's potential. The launch will be initially focused on the following priorities. First, securing payer coverage, easy Takeda has engaged payers well ahead of approval, including the three 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'll leverage ANI's expertise in patient support to ensure patients who are prescribed MCT can access it. Second, the effort will focus on converting patients from the Expanded Access Program to commercial drug. Continuity of care is the top priority. EGIS 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 MCT8 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 of established pre-approval, EAE has successfully found patients through medical conferences, field engagement, and data analytics. Increased investment in patient identification capabilities and scale will extend that reach. In ultra rare disease, an approved therapy often changes the diagnostic picture because physicians now have a reason to test for this ultra rare disease. Agios has seen this firsthand in Germany, where the number of identified patients 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 cortofen and alluvium.

Moving now to slide 25 and the overall opportunity for cortofen gel. The overall ACTH market growth is robust, and the market is expected to grow 28% in 2026 to reach approximately $1.3 billion in sales, with cortofen expected to grow 38% to 44% year-over-year in 2026. Thank you. Cortofen has strong multi-year growth potential with addressable patient populations across indications 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 are steadily reaching this segment, both with our specialty indications and with our gout expansion into prescribers. primary care, and podiatry. We've been encouraged by the continued demand we are seeing in the field and remain confident in the significant multi-year growth trajectory for Cortofen. We detail our third quarter performance on slide 27. Starting with existing specialties, we continue to drive momentum for this segment of our Cortrophin business. 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% of all primary care and podiatry prescribers initiating two 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 two factors. First, the significant demand generated by our new gout expansion team, along with the demand momentum and existing specialties, pressured our specialty pharmacy network capacity. For reference, number of new cases initiated in the five months since the gout expansion in May is approximately 85% higher than the five 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 and gout cases as well as cases in our existing specialties second in the gout expansion we observe a longer than expected conversion of new cases initiated to pay 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've taken concrete actions to improve our specialty pharmacy network capacity. Specifically, we have strengthened the support and collaboration of existing specialty pharmacies. In addition, we've expanded our specialty pharmacy network to service regional areas of especially high demand. Importantly, we are actively evaluating further expansion to support the growth in 2027 and beyond. We've 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 and 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 it's early Q4, we're 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. remain confident in the significant multi-year growth runway for Cortrophin. I'm 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, we continue to make progress to support a global return to growth for Iluvien and deliver 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 Luvian, we announced the positive top-line results from the Phase IV Open Label Synchronicity Clinical Trial in NIUPS, 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, non-infectious uveitis of the posterior segment. With that, I will now turn the call over to Steve to discuss our financials.

Stephen Carey

financials. Thanks, Chris, and good morning to everyone on the call. Now I'll review our third quarter results and 2026 guidance in more detail. Starting with slide 30, A&I 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, 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 licensing transaction with Harmony Biosciences.

We recognized 11.5 million of associated revenues in the third quarter, consisting of 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 WACICs 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 and commercial and operational outperformance. Turning to slide 31, non-GAAP cost of sales increased 20% to 111 million in the third quarter of 2026 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. Thank you. 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 Krystexxa, 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 83.3 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 December 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 nine 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 September 30th, 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 2.2 times and our net leverage was 0.7 times our trailing 12-month adjusted non-GAAP EBITDA of 283.2 million. We are in a strong financial position to fund the proposed transaction of AGITAS. 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 J.P. Morgan. Upon closing of the deal, which is expected in late 2026 to early 2027, we 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 one, driven by the initial launch phase of Emcitate, We then expect to de-lever driven by both ongoing strength in our legacy business as well as emerging profitability resulting from the acquisition. In May, our board authorized the share repurchase program of up to 100 million. TO DATE WE HAVE REPURCHASED 275,000 SHARES FOR $20 MILLION AT AN AVERAGE PURCHASE PRICE OF APPROXIMATELY 72.7 MILLION. $72.54.

Of this amount, 7.5 million was purchased as of the September 30th balance sheet date. Turning to slide 32. With three-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. Thank you. 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 Chris this morning. We are raising our Luby and 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 nine months, we are raising adjusted non-GAAP EBITDA to 290 million to 300 million. We're 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 U.S. GAAP effective tax rate of approximately 27% to 29%. With that, I'll turn the call back to Nikhil. Thank you.

Operator

Operator, could you please open it up for questions? Yes, certainly. We will now begin the question and answer session. To ask a question, you press star then 1 on your telephone keypad. If you are using a speakerphone, please pick up your phone your handset before pressing the keys. If any time your question has been addressed and you'd like to withdraw it, please press star then two. This time we will pause momentarily to assemble the roster. And today's first question comes from Bill Devon with Guggenheim Securities.

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Vamil Divan

Great, thank you for taking the questions. Congrats on the deal you announced. Maybe if I could ask one question on the Cortrophin side and then one related to the acquisition. So on Coach Rolfe, I appreciate what you're saying around the delays and the revenue conversion. What I'm 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 as we're following the prescription trends and IQVIA looks like there's a little bit of a slowdown there too. and how much of its volume versus more of this revenue conversion. And then the acquisition, I'm just not familiar with the company here quite, so still learning it a little bit on the fly here. I'm trying to understand the pricing side.

It sounds like the price in the US. be sort of the 900,000 range. We're also seeing in Europe it's around 200,000. So I'm trying to understand, maybe if you could talk about the commercial opportunity US versus XUS, and then the sort of 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 XUS?.

Nikhil Lalwani

pricing versus US. Thank you. Yes. Good morning, Vamil, and thank you for your questions. So your first question on the the Cutrofen 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 five months since the gout expansion in May is approximately 85% higher than the preceding five months. And so the answer to your question on if we had, not had the revenue conversion dynamics that we've had, would we have achieved the Q3 guidance? Absolutely.

And so we're just calibrating as we go forward and, you know, Chris spoke about the initiatives that we put in place, so the updated guidance does not assume a full benefits of those efforts and we've 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 right and we also talk 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 EGIDA's pricing, Yes, on that, EGIDIS set the wholesaler acquisition cost for MCIT at 74,026 per pack of 60, right? And based on their average daily dose of approximately 740 micrograms observed in the TRIAC trial 1 and as described in the TRIAC trial 2, they were able to get a total of 740 micrograms the U.S. prescribing information that equates to the annualized wholesale acquisition cost of approximately 950,000. And the pricing across the US and ex-US takes into account that MCT8 deficiency is an ultra-rare condition with over 1,000 patients estimated in the US, right? and many more patients outside the US. One in 70,000 males is the expected... or estimated incidence or prevalence. And so Emcitate's price reflects the value it brings to patients and families who until now had no approved treatment option. And MCT8 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. and approximately 30% of the patients dying in childhood and the persistent thyrotoxicosis putting real strain on the heart and the body as Mary had... outlined. So the label showed that the MCT8 lowered elevated T3 levels and improved key markers of thyrotoxicosis.

And the label covers patients of all ages, so they can be treated from diagnosis. And lastly, the pricing is in line with other ultra-rare disease indications.

Operator

Thank you, Vamo. Thank you. And the next question comes from Dennis Ding with Jefferies.

Yuchen Ding

Hi, good morning. Thanks for taking our questions. I had several on the agitas acquisition. So, you know, you have 60 patients in the U.S. EAP program. So wouldn't that already imply a 60 million run rate, assuming the one over the 950,000 U.S. price? And how quickly can you convert the EAP patients to commercial drugs? And I also have some follow-ups. Yep.

Nikhil Lalwani

So, as you correctly pointed out, that there are actually 60 patients on the EAP program, And there's 100 patients that the GEDIS team has genetically 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 Chris had laid out, and then to ensure that these 60 the EAP patients are transitioning to the commercial drug program, and 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 U.S. that are being treated with Emcitate 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 closure, and then we talk about 2027 performance. We are not giving 2027 revenue guidance at this time for MCT8. Thank you, Dennis.

Yuchen Ding

Got it. And then as a follow-up, so pricing is certainly weight-based, and the 950,000 estimate sort of reflects the 20-kilogram patient, and maybe that's around three to four years of age. But I'm curious about the age distribution of the patients that are out there, and if there could be a focus on some, you know, sort of the older and heavier patients. patients. And then finally, you know, I appreciate there are around 100 patients identified in the U.S., but how are you going to identify more if there's a registry in the U.S. for this disease? Thanks so much.

Nikhil Lalwani

Sure. So on the focus, we said that the median life age right now is 35 years. And so, you know, there are 100 patients identified so far. There's over 1,000 patients that we, that are, you know, you know, we believe that are there, we estimate, in the US that have MCT8 deficiency. I'll let Chris talk about how, when there is an available therapeutic for in a rare disease, then, you know, how the diagnosis expands. But on the age distribution question, which was your second question, In terms of our focus, I think, look, we want to get this treatment to all patients that are appropriate. Earlier we can get it to the patients that are younger, Mary talked about the onset of symptoms early on and then the impact can persisting, 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 in need.

And then I'll let Chris touch upon the, you know, how the, how efforts that the EDG team has already been making. It's really impressive what the EDG team has already done with patients, caregivers, and families and the foundations to increase the awareness. But I'll let Chris talk about, you know, how that will expand the diagnosis pool. Chris?.

Christopher Mutz

Yes, thanks, Nikhil, and thanks for the question. I think there's a huge opportunity now to just really invest in significant disease education first of all. I think oftentimes, you know, it's our expectation, and I think the EGDS team as well, that these patients are being seen by pediatric neurologists, pediatric endocrinologists, maybe even medical geneticists, but people aren't contemplating. a diagnosis of MCT8, 1, because as Mary said, it's a newer disease entity, but two, because, you know, there's no FDA-approved treatment, right? So, I think really, really emphasizing and investing in disease education and the appropriate specialties where we think these 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's, There are advanced analytics now using claims data and triangulating claims data with specific patient populations that we think are going to have enriched for potentially misdiagnosed patients, so patients that actually do have MCT8 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, you know, really it's about disease education. It's about ensuring that physicians now know there's an FDA-approved treatment.

And that, you know, there's a real reason and a call to action for testing, right, these patients. Perfect. Thanks so much.

Operator

Thank you, Dennis. Thank you. And that's Professor Dave Windley. I'm with Piper Sandler.

David Amsellem

Hi, this is Naoki 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 Korlym business you've lost or how much demand has not been converted to business due to the constraints at the moment? number one, and number two 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

Yes, good morning and thank you for your questions. So, you know, on the specialty pharmacy, I think that what I 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 five months, right, in the last five months over the previous five months, and that put pressure on our specialty pharmacy network We've already done a number of things. We've strengthened the support and collaboration at the existing specialty pharmacies. We also expanded our specialty pharmacy network to service the regional areas of especially high demand. And we're 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 of revenue patients to therapy, right? And you can see that in the earlier time to fill that we're seeing for patients in the latter part of Q3 and the early part of Q4. In addition to the specialty pharmacy network, we've also expanded our patient support team to further support the primary care and podiatry offices 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'll 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 more appropriate patients in need are getting the needed ACTH therapy. and we look forward to continuing to work on improving the access for ACTH therapy. Thank you for your questions.

Operator

Thank you. And the next question comes to Katerina Naksilova with J.P. Morgan.

Ekaterina Knyazkova

Thanks so much. So two quick questions on Potrufin Gel. So can you just talk a little bit more about the feedback you've been getting on the gout rollout and the response you're seeing from PCPs? You know, kind of putting aside the pharmacy bottleneck piece, just how is underlying demand, you know, coming in versus your expectations? And then second part is, so now that, you know, some PCPs are using the product in gout, 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, both in depth and breadth. In Q3, the breadth of prescribing expanded with a 67% increase in the number of prescribers, so more prescribers and 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's 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 two or more cases.

And overall, this translated into demand, you know, much higher demand with the doubling of the number of new cases initiated in Q3 versus Q2. So the demand is very strong in the gout expansion. And you brought up an interesting second point, which is when you go into primary care, 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's focused on what's in the label and we are seeing utilization of ACTH for other indications that Cortrophin is currently indicated to. As we make progress in that area, we will update you on the progress. Thank you, Katrina. Thanks.

Operator

Thank you. The next question comes from Gary Nachman with Canaccord Genuity.

Gary Nachman

Thanks. Good morning. So first a couple on Cortrophin. So on the specialty pharmacy network dynamic, I'm 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 one on Krystexxa.

Nikhil Lalwani

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

But despite those, we still saw bottlenecks in revenue conversion. And we're investing more. We're 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, the demand generation is very strong and the conversion of patients to therapy, it's a question of when, not if, right? Which brings me to the second question. We think the Gout expansion has been successful and that we need to keep, and we're 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're focused on closing out 26 getting these operational initiatives to deliver the 4Q or full year guidance and continue with momentum into 2027 and obviously closing the Aegis acquisition.

Gary Nachman

Back to you, Gary. Yes. Okay. Yes, 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. But, you know, maybe that's just going to take a little bit more time. No, we do not think that we would reconsider the extent of the expansion. Okay.

Nikhil Lalwani

In fact, the success we're 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 we have continued to make progress, they think about, we're only reaching a handful of primary care physicians and podiatrists, but several moons down, there is a huge opportunity. I mean, listen, the ACTH market, Gary, as we've outlined, right, is the addressable patient population is much, much larger than anything that we're addressing today between us and the competitor, and we feel confident that nothing has changed regarding the significant opportunity for a appropriate patients with ACTH to get treatment through ACTH. Thank you, Gary. Okay. All right. That's helpful. Yes. And then just on ACTH, so when considering the net valuation of the deal at around 430 million, just what's the time to peak of the 300 million for the product, so what's factored.

Gary Nachman

in there. It implies about a thousand patients based on the pricing that you said over time. and there's only 1,000 plus in the US. So how much will XUS contribute to that? And then just also what's the administration like for ansatibat? 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'll take the first question, which is, you know, we will advise you on the progress that we're making on the on MCOT revenues as we as the deal closes and we move forward. this time we're not giving a time to peak sales right the drug was approved a few weeks ago and we're obviously as you know as Chris highlighted it's tremendous that the Egetis team already has a hundred patients that have been validated but untreated sorry 60 of whom are on the EAP and there's over a hundred that are validated but untreated, right, in aggregate. So, my point is that, and, you know, as the, disease awareness expands, the number of diagnosed patients will expand and then we'll treat those patients. We'll talk about the trajectory and the ramp as we make that progress. I'll let Chris answer your question on the administration that happens at home for these patients. and the time that they stay on therapy. Chris? Yes.

Christopher Mutz

Yes, sure. I think that's one of the, when you think about this disabling disease population and the care that these patients need. I think the fact that this is this is a tablet, right, and that patients don't have to travel for infusions is a real advantage. And so we've heard that from the Aegis team. And so patients are able to take this orally as a tab. It's also available to be liquefied, so if there's a G-tube being used, it's able to be provided through.

Nikhil Lalwani

through G-tube and kind of in a liquid form as well. And patients stay on therapy. Yes. And Gary, the second part of your question, patients stay on therapy, throughout their life. So this is taken daily, based on their weight, the dosing, It's a scored tablet, so the dosing is adjusted based on the weight of the patient.

Operator

Thank you. And the next question is from Daniel Clark with Leerink Partners. Okay, thanks.

Daniel Christopher Clark

Great, thank you. Good morning. Just wanted to ask sort of, you know, the increase in demand that you're seeing in gout. Is that coming from, you know, more docs that are choosing to use Cortrophin Gel or is it more that they're using it more to treat more flares on a per prescriber basis? Just anything you could share there would be super helpful. Thank you. Yes, good morning and thank you for your question.

Nikhil Lalwani

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's used, to treat the exacerbations and it's, you know, when other treatment options are, so it's 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.

Daniel Christopher Clark

I hope that answers your question, Daniel. Maybe I'll try to refine it here in the follow up. Like when we think about the expansion into primary care and podiatry, and obviously that's led to a lot more demand than you anticipate. Like, is that because you're seeing more doctors sign up to use the therapy or are they just using it to treat more patients than then you anticipated? And if I didn't explain it well, I'll- Okay, got it. Got it.

Nikhil Lalwani

Sorry, yes, I understand your question, Daniel. So we'll start with from the about 10 million patients that have gout, we believe the addressable market for acute gouty arthritis flares is about 285,000 patients. And we have been serving a very... significantly under-penetrated. So our expansion into primary care and podiatry was to reach more patients, and almost all of these primary care physicians and podiatrists are naive to ACTH, so they've not been using ACTH before. And so what's happened with this expansion is we're able to reach more patients through these new prescribers, right? More than half of prescribers overall for quatrophin 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's a 67% growth 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 underpenetrated.

Operator

Very helpful. Thank you. Thank you, Daniel. Thank you. And the next question is from Ram Selvaraju with HC Wainwright.

Unknown Speaker

Hi, thanks for taking my question. If you want to just follow up on the Cortrophin specialty pharmacy comments, you know, can you just elaborate on that, you know, Was 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 a much bigger part of the pie today than perhaps you had thought of? in your initial 2026 guidance, and then the other side of that is, you know, how are the legacy indications holding up? And then maybe along those lines, there's been a few external factors in 2026 on Krystexxa. 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 of we have in neurology, nephrology, rheumatology, and also in ophthalmology and pulmonology. And they've uh those existing specialties continue to have strong momentum. And the data point we shared is that uh that momentum has continued. 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's a question of when, not if. And then very importantly, which goes into your third question. We're already taking steps 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 gouts PCPs and podiatrists that are, you know, newer to the Krystexxa enrollment to fulfillment process. And then if you zoom out and say going into 27... You know, 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, where this year we had this issue with insurance re-verifications, we obviously learned from that. We benchmarked how companies much bigger than us deal with insurance re-verifications with 5X, 10X the volumes. We've added dedicated resources. We've strengthened our patient support systems, our CRM, right? So that's already in motion.

So, you know, in Q1, that internal lever has already been pulled. Those dedicated resources are already working through the re-verifications that are going to be coming up for Q1. And then to support the demand generation, right, we are expanded, we already expanded the patient support and the specialty pharmacy network when we did the gout expansion, but we've done it even more. We've seen that that was not enough and we've 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.

Unknown Speaker

Thank you, Brandon. Great. Thanks very much. May I ask one just on the acquisition? Obviously, congratulations on that. To get to the peak sales figure, we assume an expansion of the currently diagnosed pay 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're getting treatment today? Thank you.

Nikhil Lalwani

Yes. So, as with most ultra rare conditions, there is, you know, when there is no treatment available, the diagnosis rate tends to be lower as there's greater awareness and, you know, there's significant efforts being made by the patients, by the caregivers, by the foundation, many... And by the Aegis team, right? It is truly impressive what the Aegis team has done, right? with increasing the awareness, obviously by developing this therapy, right? And there's over 300 patients across the globe that are being treated with Emcitate even today. And you're seeing the impact of their efforts even in Germany, right? Where within the course of a year, they've doubled the number of patients diagnosed, you know, versus when they launched after approval in February of 2025. A number of different initiatives, Chris spoke to some of them, will come together both to support, to increase the awareness and support the diagnosis of the appropriate patients. And we've seen this, you know, when you look at analogues 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's an awareness 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's most important, right? Getting this therapy, right, the first and only approved therapy for this debilitating condition of MCT8 deficiency and that's what we will be focused on. Thank you, Brandon.

Operator

All right. Thank you very much. Thank you. And this concludes our question and answer session. I will turn the conference back over to Nikhil Lawani 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 Aeglea 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've taken swift action to improve our performance with Ibuprofen gel and remain confident in the multiyear 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're focused on executing our strategic priorities, achieving our financial guidance and positioning ANI for long-term growth. Thank you everybody for joining us.

Operator

Thank you, Operator. Thank you. The conference has now concluded. Thank you for attending today's presentation. We now disconnect your lines.

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