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 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 Koffler.

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 Muth, Senior Vice President and Head of ANI's Rare Disease Business, and Mary Pao, Chief Medical Officer. Earlier this morning on November 5th, 2026, we released our results in 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 A&I this morning that include 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, anifarmaceuticals.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 Ajita Therapeutics. Mary will dive into more detail on MCTA deficiency and MCTA's mechanism of action. Chris will discuss the commercial opportunity for MCTA 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.

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 ANI 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 virtual 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 EGIDIS 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 revenues for the overall business, up 28% year-over-year, and adjusted EBITDA of $83.3 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 nine, while we delivered strong overall results on the top and bottom line, I want to address our cortofin performance. We've been clear that our goal for cortofin 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, cortofan 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 cortofan 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 cortofan gel net revenue guidance to 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 cortofin across indications. With respect to Illuvian, 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 alluvium 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-gap EBITDA, and raising adjusted non-gap 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 genetics 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 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 AGITAS 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 Aegidus 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 MCTA 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, MCTAID. MCTAID is the first and only approved treatment in the EU and U.S. for peripheral thyrotoxicosis associated with MCTA deficiency. This is a rare disease, impacting more than 1,000 patients in the U.S. 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 MCIT'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 Alluvian. 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, MC-8 represents an ideal product to add to our portfolio. Mary will speak to the disease in more detail shortly. MC-8 was approved in Europe in February 2025 and in the U.S. in September 2026. MC-8 became commercially available in the U.S. last week on October 27th. We estimate that approximately 1 in 70,000 males are impacted by MCT8 deficiency globally. Today, more than 100 U.S. patients have been genetically confirmed and approximately 60 U.S. patients are already receiving MCT8 through an expanded access program or EAP. This EAP gives us a clear starting point for the U.S. launch with a significant opportunity to identify, diagnose, and treat additional appropriate patients over time. MCAT 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 Aegidus shareholders to realize the forward-looking value of MCAT, 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. Site 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 Aegidus has agreed to receive from its 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, 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 diluted to adjusted non-GAAP EPS in year one, driven by investments to support the US commercial launch. We expect the deal to close in late 26 or early 27, subject to customary closing conditions. And with that, I'll turn the call over to Dr. Mary Pao are Chief Medical Officer to provide an overview of MCT8 deficiency. Mary?

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 MCT8. 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 8. This is a protein that carries thyroid hormone into the cells. Because it's located on the X chromosome, it's X-linked and infects almost entirely males 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 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 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 and 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 MCT8 came along. So turning to slide 16, we're going to talk a little bit about the profound intellectual and physical disabilities that come with MCT8 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 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 based on 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 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'll take a look at the mechanism of action, which I briefly went through earlier. MCT8 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 eight, we can show that MCT8's FDA approval was supported by robust clinical evidence, and there's two key studies that were involved. First is called the TRIACT, and this was a 30-day randomized double-blind placebo-controlled withdrawal study. So patients who were already taking MCT 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 MCT 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 MCT therapy. Every patient switched to placebo had a larger increase in T3 than any patient who received MCT. 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 118 nanograms per deciliter, which is a highly significant reduction in T3. 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. 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 mCetate on T3 as well as clinical markers of virus toxicosis. 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 MCT 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. And finally, we have data from the U.S. 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?

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. A number 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 Solaris and PNH and HUS and Sorenzic and Hypophosphatasia. We bring the experience and capabilities required for the MCTate 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. As 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 MCT8. It is a real testament to the team at Aegis that as of today, nearly 300 patients around the world are being treated with Emsutate 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 Emsutate treatment. Turning to slide 22. MCT8 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, two key features stand out. First, the label is broad. MCT8 is indicated for the treatment of peripheral therotoxicosis in adults and pediatric patients with MCT8 deficiency with no age restriction. So every patient with a confirmed diagnosis is eligible for treatment. MCSAID 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 EGDS 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 MCT8 deficiency in the U.S., over 100 have been diagnosed and validated by the eGITIS 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 MCT8 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 Aegis 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 EGDS 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. And I plan to supplement this team with our additional resources and scale to drive higher awareness of MCTA deficiency and the new availability of an FDA-approved treatment. EGDS 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 MCTA's potential. The launch will be initially focused on the following priorities. First, securing payer coverage. EGDS 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 MCTA 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 MCTA 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. 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 MCTA and MCTA 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 pre-approval, Aegidus has successfully found patients through medical conferences, field engagement, and data analytics. ANI's increased investment in patient identification capabilities and scale will extend that reach. An ulcerative disease and approved therapy often changes the diagnostic picture because physicians now have a reason to test for this ulcerative disease. Aegidus 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 ulcer or 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. Cortrophin has strong multi-year growth potential with addressable patient populations across indications significantly under-penetrated 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 into 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 Cortrophin. We detail our third quarter performance on slide 27. Starting with existing specialties, we continue to drive momentum for this segment of our cortofin 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% 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 in the five preceding months, highlighting the magnitude of demand we are seeing. Simply put, this 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 Cortofin enrollment 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 expansions to support the growth in 2027 and beyond. In parallel, 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 fulfillment process for Cortrofen. 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 multi-year growth runway for Cortofen. I'm proud of the entire Cortofen 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 Luvian, and 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 cortofen, with cortofen 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 to 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.

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 A&I's diversified business, led by growth of our rare disease unit, brand royalties, and continued strong performance within our generics portfolio. Revenues from Cortofengel 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. Alluvian 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 Wakex, 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 Wacix 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 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. 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. Nongap selling, general, and administrative expenses increased 32.4% to $84.2 million in the third quarter, driven by our gout expansion for cortofin, 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 Thank you for joining us. We are in a strong financial position to fund the proposed transaction of EGITUS. 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 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 MCITATE, 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. Year-to-date, we have repurchased 275,000 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 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. We are revising our guidance for cortofan 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 alluvian 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 are also raising our non-GAAP earnings per share to be between $9.37 and 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-gap 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, could you please open it up for questions?

Yes, certainly. We will now begin the question-and-answer session. To ask a question, you may press star then 1 on your telephone keypad. If you are using a speakerphone, Please pick up 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. At this time, we will pause momentarily to assemble the roster. And today's first question comes from Bill Devon with Kusenheim Securities.

Great. Thank you for taking the questions. Congrats on the deal you announced. Maybe if I could ask one question on the Cortropin side and then one related to the acquisition. So on Court 12, 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 expected for the quarter and for the full year? Because as we're following the prescription trends in IQV, it looks like there's a little bit of a slowdown there, too. So I'm just trying to understand how much of it's volume versus more of this revenue conversion. And then the acquisition, I'm just, you know, not I'm trying to understand the pricing side. It sounds like the price in the U.S. would 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 can talk about the commercial opportunity U.S. versus ex-U.S. 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 pricing versus US?

Thank you. Good morning, Vamu, and thank you for your questions. So your first question on the Kotrofen 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 Chris spoke about the initiatives that we've 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 in the time to therapy or time to first fill in late Q3, early Q4 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 Aegidus pricing. Yeah, on that, Aegidus set the wholesaler acquisition cost for MCT 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 U.S. prescribing information, that equates to the annualized wholesale acquisition cost of approximately $950,000. And, you know, the pricing across the U.S. and ex-U.S. takes into account that MCT88 deficiency is an ultra-rare condition with over 1,000 patients estimated in the U.S., right, and many more patients outside the U.S. One in 70,000 males is the expected or estimated incidence or prevalence. And so MCTA's price reflects the value it brings to patients and families who until now had no approved treatment option. And MCTA 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 pyrotoxicosis putting real strain on the heart and the body as Mary had outlined. So the label showed that the MCT lowered elevated T3 levels and improved key markers of pyrotoxicosis 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. Thank you, Vamo.

Thank you. And the next question comes from Dennis Deng with Jefferies.

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, you know, 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. So, as you correctly pointed out, that there are actually, there are 60 patients on the EAP program, and there's 100 patients that the GEDIS 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 Chris had laid out. and then to ensure that these 60 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 for these patients that have been on the EAP program and also on global managed access program. 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 MCT8 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.

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. 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.

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 estimate in the U.S. that have MCTA deficiency. I'll let Chris talk about how when there is an available therapeutic in a rare disease, then how the diagnosis expands. But on the age distribution question, which is your second question, in terms of our focus, I think, look, we want to get this treatment to all patients that are appropriate. The earlier we can get it to the patients that are, you know, younger, right, 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, right, in need. And then I'll let Chris touch upon the You know, how the efforts that the EGDIS team has already been making. It's really impressive what the EGDIS 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 diagnosed pool. Chris?

Yeah, 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. Oftentimes, you know, it's our expectation, I think, and I think the Adjida 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 MCT81 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 is Thank you for joining us today. 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. Thank you, Dennis.

Thank you. And that's Professor David Ansel. I'm with Piper Sandler.

This is now Keon 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 control from business you've lost or how much demand has not been converted to business due to the constraints at the moment? That's 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 fall here? Thank you.

Yeah. Good morning and thank you for your questions. So, you know, 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 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've 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 already 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. Both these efforts 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, there is no significant change in the access. 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. And the next question comes to Katerina Naksilov of JP Morgan.

Thanks so much. So two quick questions on Pertrofen 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.

Sure. Good morning, Katrina, 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 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 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, 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 cortofin 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 cortofin is currently indicated to. As we make progress in that area, we will update you on the progress. Thank you, Dr. Trina.

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

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 MCAT.

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, 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 cotrophin enrollment to fulfillment process. So both these dynamics together is what caused the revenue conversion dynamic that we've seen. 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, 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 GATT expansion has been successful and that we need to keep, you know, 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, you know, closing out 26th. by getting these operational initiatives to deliver the 4Q cortofin guidance and continue with momentum into 2027 and obviously closing the agitis acquisition. Back to you, Gary.

Yeah, 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. 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. In fact, the success we're seeing and the question that Ekatrina asked earlier about potential or usage even beyond gout at these offices makes us think about not now, but at some point in the future when we continue to make progress, we're only reaching a handful of PrimaCare physicians and podiatrists, right? But, you know, 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 appropriate patients with ACTH. to get treatment through ACTH. Thank you, Gary. Okay. All right.

That's helpful. Yeah. And then just on MCTA. So, you know, 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 in there? It implies about 1,000 patients based on the pricing that you said over time, and there's only 1,000 plus in the U.S. So how much will XUS contribute to that And then just also, what's the administration like for MCT? 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.

Sure. So I'll take the first question, which is, you know, we will advise you on the progress that we're making on MCT revenues as the deal closes and we move forward. At this time, we're not giving a time to peak sales. The drug was approved a few weeks ago, and we're obviously, as Chris highlighted, it's tremendous that the Adidas team already has 100 patients that have been validated but untreated, sorry, 60 of whom are on the EAP, and there's over 100 that are validated but untreated, right, in aggregate. So my point is that as the disease awareness expands, the number of diagnosed patients will expand and then we'll treat those patients. But 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?

Yeah, sure. I think that's one of the – when you think about this disabled disease population and the care that these patients need, I think the fact that 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 a G-tube and kind of in a liquid form as well.

And patients stay on therapy... 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. Okay, thanks.

Thank you. And the next question is from Daniel Clark with Learing Partners.

Oh, great. Thank you. 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 cord stroke and 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.

Yeah, 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'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. I hope that answers your question, Daniel.

Maybe I'll try to refine it here in the fall. When we think about the expansion into primary care and podiatry, and obviously that's led to a lot more demand than you anticipated, 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 you anticipated? Okay, got it, got it.

Sorry. Yeah, I understand your question, Daniel. So, you know, we'll start 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, that's significantly under-penetrated. So our expansion into primary care and podiatry was to reach more patients, right? 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 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. Even within this gout expansion, quarter on quarter, we talked about there's 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.

Thank you, Daniel. Thank you. And the next question is from some random folks with J.C. Reinright.

Hi. Thanks for taking my question. If you want to just follow up on the cortropin specialty pharmacy comments, can you just elaborate on that? 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? Then 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, you know, along those lines, you know, there's been a few external factors in 2026 on cortropin. 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? 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 those existing specialties continue to have strong momentum and the data point we shared is that 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 then when we had originally anticipated in the initial guidance. 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 gout PCPs and podiatrists that are newer to the Cutrofen enrollment to fulfillment process. And then if you zoom out and say going into 27, we have already activated a number of different levers to support the significant strong growth going into 2027. So starting from Q1, 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. So that's already in motion. So 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, 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. 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 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. Yeah.

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, 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's over 300 patients across the globe that are being treated with MCTate even today. And, you know, you're seeing the impact of their efforts even in Germany, where within the course of a year, they've doubled the number of patients diagnosed versus when they launched after approval in February of 2025. So 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, 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 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. At the end of the day, that is what's most important, getting this therapy, the first and only approved therapy for this debilitating condition of MCTA deficiency. And that's what we will be focused on. Thank you, Brandon.

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 Lalwani for any closing comments.

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 DeJesus 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 Coprofen 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're 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. Thank you. The conference has now concluded. Thank you for attending today's presentation.

We now disconnect your lines.