Amneal (AMRX) Q2 2026 Earnings Call Transcript

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DATE

Thursday, July 30, 2026 at 8:30 a.m. ET

CALL PARTICIPANTS

• Head of Investor Relations - Anthony DiMeo
• Co-Founder and Co-Chief Executive Officer - Chirag Patel
• Co-Founder and Co-Chief Executive Officer - Chintu Patel
• Chief Financial Officer - Anastasios Konidaris
• Specialty - Joe Renda
• Chief Legal Officer - Jason Daly

TAKEAWAYS

• Revenue -- $796 million, up 10% year over year driven by broad-based momentum across all three business segments.
• Adjusted EBITDA -- $206 million, up 12% year over year reflecting strong revenue growth and disciplined expense management.
• Adjusted EPS -- $0.30, up 20% year over year due to higher profitability and lower interest expense.
• Affordable Medicines Revenue -- $490 million, up 13% year over year driven by complex generics, Women's Health products, and injectables.
• Specialty Revenue -- $149 million, up 17% year over year reflecting strong uptake of CREXONT, UNITHROID, and BREKIYA.
• AvKARE Revenue -- $157 million, down 4% year over year as growth in government channels was offset by declines in the low-margin distribution business.
• Adjusted Gross Margin -- 46.2%, up 60 basis points year over year due to favorable product mix and operating efficiencies.
• 2026 Revenue Guidance -- $3.1 billion to $3.2 billion, representing an increase of $50 million from previous expectations.
• 2026 Adjusted EBITDA Guidance -- $750 million to $780 million, reflecting an increase of $10 million despite anticipated flood impacts.
• 2026 Adjusted EPS Guidance -- $0.96 to $1.06, raised by $0.01 following successful debt repricing and improved profitability.
• Capital Expenditures Guidance -- $150 million, increased from $110 million to support U.S. injectable expansion and Women's Health demand.
• New Product Revenue -- $45 million in the second quarter, contributed by recent launches in ophthalmology and urology.
• Debt Repricing Savings -- 50 basis points reduction on a $2.084 billion Term Loan B, expected to save $12 million in annual interest.
• Kashiv Financial Benefits -- $400 million to $500 million in expected value through tax incentives and the elimination of milestone and profit-sharing obligations.
• Biosimilar Manufacturing Capacity -- 26,000 liters by late 2026, with planned expansion to 75,000 liters by 2028 through the Kashiv acquisition.
• Generic Pipeline -- 12 to 15 high-value complex ANDA filings planned for the remainder of 2026, including two inhalation products.
• Iohexol Opportunity -- $50 million plus potential annual revenue once the full SKU portfolio and capacity expansion are complete in 2027.
• GLP-1 Supply Timeline -- 2030, with facilities expected to be operational by 2029 to support the Pfizer partnership.
• First Half Performance -- 7% revenue growth, 16% adjusted EBITDA growth, and 27% adjusted EPS growth compared to the first half of the prior year.

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RISKS

• Chintu Patel stated, "the Gujarat region experienced a severe rainfall and flooding, which impacted one of our facilities in India," resulting in an estimated $20 million negative impact on the 2026 outlook.
• Chirag Patel stated, "XOLAIR is towards very late end of the year or could spill into the January 5," indicating the potential for a key biosimilar launch to move into the following fiscal year.

SUMMARY

Management reported that Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) is currently in its most transformative period, characterized by a strategic pivot toward a fully integrated global biosimilars platform. The company is advancing its acquisition of Kashiv BioSciences to capitalize on an estimated 118 biologics losing exclusivity in the United States over the next decade. Management raised its full-year financial guidance for the second time this year, citing strong performance in the Specialty and Affordable Medicines segments and successful debt repricing. Strategic investments are being directed toward complex dosage forms, including transdermals and sterile injectables, to address market demand and drug shortages.

• Co-CEO Chintu Patel noted the Brookhaven, New York site was selected for the "FDA's PreCheck Pilot Program," an initiative alongside companies like Eli Lilly to strengthen U.S. drug manufacturing resiliency.
• The biosimilar strategy involves a portfolio mix where 75% of products focus on targeted lower-competition molecules and 25% address larger market opportunities.
• Co-CEO Chirag Patel attributed the success of the CREXONT launch to clinical data showing "3 or more hours of 'Good on' time per day" for Parkinson's patients compared to prior therapies.
• Management stated that 80% of CREXONT prescriptions are currently originating from general neurologists, supporting the goal of making it a first-line treatment.
• The company plans to triple its manufacturing capacity for estrogen patches by 2027 to meet increased demand following updated FDA guidance in the Women's Health category.
• Management confirmed that the company's net leverage is projected to fall below 3.0x by 2028 as cash flow from the Kashiv integration and new product launches scales.
• CFO Konidaris noted that the increased capital expenditure budget of $150 million is specifically aimed at capitalizing on near-term market demand for injectables and transdermal products.

INDUSTRY GLOSSARY

• 505(b)(2): A regulatory pathway for drug approval that allows the FDA to rely on existing data from previously approved drugs.
• ANDA: Abbreviated New Drug Application, the formal process for obtaining approval to market a generic drug in the United States.
• Biosimilar: A biologic medical product that is highly similar to an already approved biological medicine and has no clinically meaningful differences.
• GLP-1: Glucagon-like peptide-1, a class of medications primarily used to treat type 2 diabetes and obesity.
• Iohexol: A radiographic contrast medium used in X-ray imaging and CT scans.
• Lanreotide: A peptide medication used for the treatment of acromegaly and certain neuroendocrine tumors.

Full Conference Call Transcript

Operator: Good morning, and welcome to the Amneal Pharmaceuticals Second Quarter 2026 Earnings Call. I will now turn the call over to Amneal's Head of Investor Relations, Tony DiMeo.

Anthony DiMeo: Good morning, and thank you for joining Amneal Pharmaceuticals second quarter 2026 earnings call. Today, we issued a press release reporting Q2 results. The earnings press release and presentation are available on the IR page of amneal.com. Certain statements made on this call regarding matters that are not historical facts, including, but not limited to, management's outlook or predictions, are forward-looking statements that are based solely on information that is now available to us. Please see the sections entitled Cautionary Statements on Forward-Looking Statements in our press release and presentation for factors that may impact future performance. We also discuss non-GAAP measures. Information on use of these measures and reconciliations to GAAP are in the earnings release and presentation.

On the call today are Chirag and Chintu Patel, Co-Founders and Co-CEOs; Tasos Konidaris, CFO; Joe Renda for Specialty; and Jason Daly, Chief Legal Officer. I will now hand the call over to Chirag.

Chirag Patel: Thank you. Good morning, everyone. Amneal is in the midst of the most transformative period in our company's history. We are growing as one of the America's leading Affordable Medicines businesses with an increasingly diversified and high-impact medicines portfolio, including Specialty brands, biosimilars, GLP-1s and complex generics across dosage forms such as transdermals and injectables. As we execute our strategy, we are building a larger, more impactful Amneal. That continued momentum is reflected in our second quarter results, where the company delivered revenue of $796 million, adjusted EBITDA of $206 million and adjusted EPS of $0.30. At the halfway point of the year, we are pleased to once again raise our 2026 outlook.

This year reflects our seventh consecutive year of top and bottom line growth. As a purpose-driven company, we have a tremendous opportunity to help the next era of Affordable Medicines here in the United States and globally by expanding access for patients and providers. While Amneal has always been growth-oriented, the scale of the opportunity in front of us today has never been greater. With that, let me touch on key growth opportunities. First, in Affordable Medicines, our base business remains strong, resilient and growing with highly relevant and in-demand therapies. In Women's Health, demand for transdermal patches increased following the revised FDA guidance late last year. We are increasing our capacity.

Looking forward, our pipeline remains focused on high-value opportunities such as lanreotide where complexity, reliable supply, customer relationship and executions are key. Second, in biosimilars, we're building a new large growth platform for Amneal. With the pending acquisition of Kashiv, we would become a fully integrated global biosimilar player from development to commercial supply. And the timing is incredibly compelling. The U.S. biosimilars market is entering a major growth cycle driven by an unprecedented wave of biologics losing exclusivity, streamlined regulatory pathways, attractive commercial structures emerging, including private labels and accelerating market adoption.

Over the next decade, 118 biologics are expected to lose exclusivity in the United States alone, with relatively limited development expected for most molecules, accordingly, we see a broad set of biosimilar opportunities with limited competition that can support reliable and repeatable value creation. Amneal is well positioned to capitalize on these opportunities. Approximately 75% of our biosimilar portfolio will be focused on targeted lower competition while 25% will address larger market opportunities. That mix gives us significant growth potential and meaningful upside. Biosimilars align with our commercial strength as well. Through private label and customer relationship, we can bring products to market efficiently, leveraging our leading U.S. retail and institutional presence, channel access and scale.

This is a national extension of our Affordable Medicines strategy. Overall, biosimilars are the next major growth area for Amneal and fit directly in our mission, expanding access, providing affordability and building a durable long-term growth platform. Third, in Specialty, we have a differentiated branded product portfolio. CREXONT continues to gain traction and recent Phase IV data reinforces its potential to become a first-line treatment option for Parkinson's patients. Also, BREKIYA continues to see very strong uptake in its first several quarters on the market as it addresses an important unmet need for migraine and cluster headache sufferers.

Fourth, in distribution, AvKARE continues to provide diversification and access to important government and institutional channels, representing a meaningful opportunity to grow this business over time. In summary, we are incredibly excited about the ongoing strategic evolution of Amneal and highly confident in our ability to sustain this momentum going forward. I'll now turn it over to Chintu.

Chintu Patel: Thank you, Chirag, and good morning, everyone. I would like to thank our Amneal team for another quarter of very strong execution. Our team continues to deliver across operations, quality, supply chain, R&D, commercial execution and customer service. This consistency allows us to grow while also building towards the next generation of opportunities such as Specialty, biosimilars and GLP-1s. Let me begin with an update on one of our manufacturing sites in India. One week ago, the Gujarat region experienced a severe rainfall and flooding, which impacted one of our facilities in India. Most importantly, all Amneal employees are safe and accounted for. We expect a limited impact on a select number of products.

We look to resume operation within the next few weeks. I will provide an update on 3 areas: first, the strength of our operating platform; second, the strategic fit and capabilities Kashiv brings in biosimilar; and third, the continued momentum across our pipeline. First, in operation, our global high-quality manufacturing and supply chain capabilities remain a core competitive advantage. If you walk into an Amneal facility today, it looks remarkably different than just several years ago. Through digitization, automation and deploying AI tools in different areas, we are unveiling our next generation of manufacturing and quality while also driving continued efficiencies. Strategically, we have built a broad operational network with deep expertise across dosage forms. This matters more than ever.

Patients, providers and all stakeholders of the health care system are focused on the quality, reliability and resiliency of the pharmaceutical supply chain. We are excited to expand our capabilities and capacity in complex dosage forms, including transdermals, sterile injectables and long-acting depots, enabling Amneal to increase our volumes and drive very meaningful near-term growth. Our scale, leading U.S. manufacturing footprint and strong technical capabilities positions us to deliver reliable, high-quality supply while addressing important market needs and drug shortages. To that point, we are pleased to share that Amneal's Brookhaven New York site was recently selected as 1 of only 7 companies in the FDA's PreCheck Pilot Program, alongside other leading companies such as Eli Lilly and Regeneron.

The program is intended to advance U.S. drug manufacturing and strengthen supply chain resiliency by allowing earlier FDA engagement on facility readiness and support access to critical medicine. For Amneal, it is an important recognition of our robust U.S. manufacturing, particularly as we expand into sterile injectable manufacturing here in the U.S. over the next few years. Second, we are very excited about the Kashiv acquisition, which will add the in-house biologics capabilities we need to succeed in biosimilars. The end-to-end capabilities will span cell line and clone development, protein characterization, process development, clinical execution, regulatory expertise and scaled biologics manufacturing in India and U.S.

Kashiv is a biologics platform built over a decade with deep scientific expertise across monoclonal antibodies, fusion proteins, cytokines, [ microbial ] products and other complex modalities. Kashiv's drug substance capacity is expected to expand from approximately 26,000 liters by the end of 2026 to approximately 75,000 liters by 2028. With Kashiv, we will be able to do it all in biologics. Kashiv brings the science, development and manufacturing engine and Amneal brings the U.S. commercial engine with our leading retail position and channel expertise. This is a powerful combination. Together, this combined model will allow us to advance multiple molecules at the same time, make smart portfolio decisions, move quickly and capture more economics across the value chain.

With our current and future biosimilar capacity, we are well positioned to supply a meaningful share at launch with excess capacity to respond to market demand as needed. In addition, the combined pipeline of over 20 biosimilar programs supports a meaningful number of new launches over time. We are very excited about upcoming biosimilar opportunities for XOLAIR, ORENCIA, CIMZIA and Nplate, which are attractive molecules with significant market potential and relatively limited competition. We believe each has the potential to become a meaningful growth driver. Longer term, the pipeline extends well into the 2030s, providing substantial runway for growth. Third, turning to our Affordable Medicines pipeline.

We are in the midst of the most concentrated and impactful wave of high-value new launches in our company's history. Importantly, it is not just the number of launches that matters, it is the value, complexity and durability of these products. This momentum is the result of choices we made many years ago. We deliberately prioritized complex generics and differentiated dosage forms, including injectables, ophthalmics, inhalation products, drug device combinations, 505(b)(2) opportunities and other non-oral solid dosage forms, where technical complexity and execution create long-term durable value. Our recent approvals and upcoming launches show the strategy is working.

This includes the recent approval of romidepsin in oncology, additional strengths of presentation of iohexol and ready-to-use sodium bicarbonate, our latest 505(b)(2) injectables, along with potential approval of lanreotide in Q3. Each product reflects the high-impact opportunities that we have been building towards and demonstrate the strength of our Affordable Medicines pipeline. And the wheel of innovation continues to turn with another 12 to 15 high-value complex ANDA filings planned this year, including 2 more metered-dose inhalation products. These opportunities exemplify Amneal's core strength, strong R&D, complex manufacturing, deep customer relationships and a track record of reliable supply. We are using the same playbook that built our Affordable Medicines business and applying it to biosimilars.

In Specialty, we are pleased with the continued strong performance of CREXONT and BREKIYA. These successful product launches reflect our ability to develop new medicines, build brands and bring forward therapies that improve patient care. For CREXONT, the real-world evidence for Parkinson's patients is very compelling. We recently shared data from our first Phase IV open-label study that showed patients converting to CREXONT had 3 or more hours of "Good on" time per day versus RYTARY and other carbidopa/levodopa therapies and a meaningful improvement in system -- in symptom control. In Q4, we are starting a new Phase IV study looking at the impact of CREXONT on treatment-naive patients recently diagnosed with PD and disease progression.

More broadly, we are building on this Specialty foundation with additional R&D pipeline opportunities. While CREXONT and BREKIYA are key growth drivers today, they represent the beginning of a broader Specialty pipeline that we are advancing and we look to share more in the future. Taken together, we are well positioned for continued growth and remain laser-focused on executing across our key operational, commercial and pipeline opportunities. I will now hand it over to Tasos.

Anastasios Konidaris: Thank you, Chintu, and good morning, everyone. The second quarter played out as expected with revenue growth accelerating and broad-based momentum building across our business. Consequently, we are very pleased with our continued strong financial performance and ability to raise our 2026 outlook again this quarter, reflecting the strength and diversification of our business, a number of key growth drivers and the success of the business model we have strategically built over several years. We expect this momentum to continue through the balance of 2026 and into 2027 and beyond. For the second quarter, total net revenue was $796 million, up 10%. Adjusted EBITDA was $206 million, up 12%, and adjusted EPS was $0.30, up 20%.

Our results were driven by strong execution across our 3 business segments, favorable product mix and operating expense discipline. In the second quarter, Affordable Medicines delivered revenue of $490 million, up 13%, reflecting the strength of our broad-based complex portfolio, including our Women's Health products, injectables and higher naloxone sales. In addition, new product launches added $45 million to second quarter revenue growth, including 2 recently launched products, one in ophthalmology and one in urology. Our Specialty revenue was $149 million, up 17%, driven by continued momentum in CREXONT, UNITHROID and BREKIYA, all ahead of expectations.

Moving on to AvKARE, where second quarter revenue was $157 million, down 4%, similar to the first quarter as growth in the government channel was offset by the low-margin distribution business as we expected. As we have said in the past, we remain focused on the unique value we provide in the government channel and continue to expand AvKARE's profitability. Moving down the P&L. Our second quarter adjusted gross margin was strong at 46.2%, up 60 basis points year-over-year, reflecting favorable mix and continued operating efficiencies. Adjusted EBITDA grew 12% due to strong revenue growth, gross margin expansion and disciplined expense management.

From an adjusted EPS perspective, the second quarter grew 20%, reflecting the adjusted EBITDA growth and lower interest expense. Let me take a moment to acknowledge the strength of our first half financial performance with total revenues up 7%, adjusted EBITDA up 16%, and adjusted EPS growth of 27%. Furthermore, I'm pleased to report that we recently repriced our $2.4 billion (sic) [ $2.084 billion ] Term Loan B due in 2032 and reduced our interest expense by 50 basis points, which equates to $12 million in annual interest expense savings. Given the strength of our business, we're very pleased to raise our full year 2026 guidance against this quarter.

We're increasing our revenue outlook by $50 million to $3.1 billion to $3.2 billion with high single-digit growth expected in both Specialty and Affordable Medicines. Also, we're raising our adjusted EBITDA guidance by $10 million between $750 million and $780 million, reflecting strong revenues and higher gross margin. This guidance includes an estimated $20 million of negative impact anticipated as a result of the recent flood in our India facility, as Chintu mentioned earlier on. From an EPS perspective, we're increasing our guidance by $0.01 between $0.96 and $1.06 due to our higher profitability and lower interest expense following our most recent successful debt repricing.

From a CapEx perspective, we're increasing our expectations from about $110 million to about $150 million to capitalize on multiple near-term opportunities that we see in the marketplace, such as greater market demand for our Women's Health products and injectable expansion in the U.S. Finally, we're maintaining our operating cash flow guidance. Turning to Kashiv for a second. We're entering the transaction from a position of strength, supported by a diverse set of growth drivers, strong cash flow and disciplined balance sheet management. This progress was further validated in April when we received a one-notch credit rating upgrade in our most recent successful Term Loan B repricing. As we have outlined, the Kashiv transaction is compelling both strategically and financially.

First, the acquisition enable us -- enables us to be a leader in the multibillion-dollar global biosimilars market that is growing rapidly. Second, we expect to capture $400 million to $500 million in financial benefits driven by tax and local incentives as well as eliminating milestone and profit-sharing obligations. Third, we see a clear path to deleveraging with net leverage below 3x by 2028. We expect the Kashiv transaction to close over the next few weeks, pending shareholder vote tomorrow and satisfaction of closing conditions. With that, I will turn the call back to Chirag.

Chirag Patel: Thank you, Tasos. Our Q2 results demonstrate the strength of Amneal's diversified business and the momentum across our growth platforms. We are delivering strong performance today with more significant opportunities ahead than any point in our company's history. The pending Kashiv acquisition is a natural extension of our strategy that will create a fully integrated global biosimilar platform, provide us access to a very large market opportunity and establish a major new long-term growth pillar. We are excited about the future and the substantial value creation ahead. Our goal remains clear to become America's #1 Affordable Medicines company and a leading global provider of essential medicines because innovation only matters when it reaches the patient.

With that, let's open the call for Q&A.

Operator: [Operator Instructions] Your first question is from the line of Glen Santangelo from Barclays.

Glen Santangelo: Yes, just 2 quick ones for me. Chirag, I think I heard you said you're still expecting the timing for lanreotide to be 3Q. And if memory serves me correct, the biosimilar for XOLAIR, you're expecting later in the fourth quarter. And so I'm just kind of curious as to maybe what you have included in your -- in the second half fiscal '26 guide for these launches? And then my second question is really around Kashiv. I think at the time of the deal, you said you're expecting to have 6 commercial biosimilars in the market by 2027 with a $14 billion TAM.

I was just wondering if you could just give us more -- an update on the timing and maybe a little bit more transparency into which launches will be more meaningful here?

Chirag Patel: So, lanreotide is on its way. That's what we feel as of today. It has official goal date in Q3. So that we have included some of the forecast number, but not probably the market...

Anastasios Konidaris: Very conservative on that.

Chirag Patel: Conservative is included. And XOLAIR is towards very late end of the year or could spill into the January 5. So nothing is included for XOLAIR for this year. And in Kashiv BioSciences, or your question on the 6 commercial biosimilars, as you know, we market ALYMSYS, RELEUKO, FYLNETRA. We are launching Prolia and XGEVA and look forward to launch XOLAIR sometimes next year, hopefully very early. So that becomes the 6 biosimilars commercialized by next year and more to follow there on in '27, '28, '29, very exciting pipeline.

Operator: Your next question comes from Chris Scott with JPMorgan.

Ekaterina Knyazkova: This is Ekaterina on for Chris. Just 2 questions from us. So first, just on tariffs, your thoughts on some of these recent headlines from the administration. How should we think about potential impact both for Amneal and the industry? And have there been any discussions between generic manufacturers and the administration since the announcement? And then second question is just on CREXONT. It seems like another very strong quarter for the product. Just any interesting trends you guys are seeing in terms of where uptake is coming from or anything else you're kind of seeing in that market?

Chirag Patel: As you know, Amneal has a very vast manufacturing network in the United States. We always look and also expanding our capacity in the United States in sterile and patches as well. As far as the recent announcement, we look forward for more information and we'll collaborate with administration as we move forward. Your second question on CREXONT, we're seeing 80% of the scripts coming from general neuro, which wasn't the case for RYTARY, and that continues to happen. As you know, 80% prescription are written by the general neurologist. So very exciting. The Phase IV data is exciting as well, well received and the script trend is -- keep going up every week.

And it's truly a needed therapy for the Parkinson's patient, and our goal will be to make that a first-line therapy replace the immediate release product.

Operator: Your next question comes from David Amsellem from Piper Sandler.

David Amsellem: So a couple for me. First on iohexol with the additional SKUs approved, can you talk about how big of an opportunity that could be, not just this year, but also in '27, if you can quantify that and your views on how long that could be a situation where there's limited competition? And a similar question on lanreotide. Can you just level set for us to the extent you get approved, how long that could be a limited competition situation? And then lastly, on your Specialty business and particularly neurology, what's your appetite for adding assets where you can leverage your existing commercial infrastructure in neuro?

Chintu Patel: So iohexol is a very complex product, and it requires very good supply chain control and a manufacturing footprint. We are very excited with the new SKUs that are getting approved. We are expecting other 1 or 2 more strengths to get approved by end of the year. So I think going into next year, we'll complete the entire basket because it has multiple strength. Same time, we have increased our capacity this year, and we look forward to capitalize on the full market potential next year. From a quantification perspective, we think this is a $50-plus million opportunity, maybe more going forward, and we have secured a very good supply chain. Regarding lanreotide, it's the same thing.

It's a very complex manufacturing. As you know, it's a drug device combination. It's a peptide. It's a very unique formulation. So it has lots of multiple barriers of entry from coming into the market. We have a dedicated site and facility. We are controlling our in-house supply chain. So we are very positive and optimistic on staying a market leader upon the launch in Q3 as anticipated. So lanreotide, and we have inventory to go, we have perfected the manufacturing. So we look forward to lanreotide launch in Q3 of this year.

Chirag Patel: Great. And I'll take the second one on the Specialty M&A potential. As we have stated before, company's focus and goal will turn to the Specialty side going from next year and many years to come after that. We have a full mass and great infrastructure for small molecule and large molecule with the pending Kashiv acquisition. So we'll keep investing in our internal growth, R&D and CapEx for affordable medicines and not take our eyes off. It's a great business. Even the existing business is growing remarkably with the new pipeline launches, the Women's Health, with the lidocaine expansion, with the injectable expansion in the United States. I mean we could not even supply more.

So that is just a very positive sign. And as you know, David, that would be positive because the 90% scripts are written using generics product and always the complex products are run in shortages, and we are there to support that. So very excited about that. And biosimilars, we have enough and we will keep expanding with CapEx. Now with excess cash and other means, we would be focusing on CNS assets. Our team is looking at it. And we are also looking at oncology assets. We'll be adding a pipeline internally and externally, and we'll share with you when we are ready.

Operator: Your next question comes from Ash Verma with UBS.

Ashwani Verma: Congrats on the progress here. So I had 2 questions on both individual products. Maybe just on like lanreotide. So yes, you've been reiterating like 3Q as an approval and launch. Just help us understand if there could be like any gating items from FDA side on granting the approval? Have you had any kind of like a late-cycle review meeting recently? Any back and forth with the FDA that you can talk about? And then on iohexol, so this one, yes, so you're building out the SKU portfolio. Obviously, like is the adoption of iohexol contingent on you having first all the SKUs?

Or can we start to see meaningful revenue contribution from what you have right now and then it sort of like builds out from the later dosing after that? So if you can give any comment on that, that would be great.

Chintu Patel: On the lanreotide, I'll take the first one. We responded to all the queries of FDA very -- with very comprehensive response. We are very optimistic. As of today, we haven't had any negative feedback from FDA. So we believe no news is a good news. It is under priority review, as FDA understand, it's an unmet need. So we remain very, very optimistic about 3Q launch, and we have inventory to go upon the approval of the product immediately. On iohexol, our strategy was to get all the SKUs together. So our R&D has completed all the work.

And it's not necessary to have all the SKUs, but I think we took a strategic position so that we can get a bigger bite at the market share. And also we are expanding the capacity. So in '26, iohexol does not have meaningful revenue, but in '27 onwards, it will add substantial revenue growth.

Operator: Your next question comes from Matt Dellatorre with Goldman Sachs.

Matthew Dellatorre: Congrats on the strong quarter. Maybe stepping back a bit, Chirag, you kicked off the call highlighting how Amneal is in the most transformative period in the company's history. I think the 2 big things that come to mind here is obviously the recent biosimilars integration and also the Pfizer GLP-1 partnership. I know you discussed the biosimilar side a bit already, but maybe just walk us through what you're most focused on with respect to both of these programs over the next 6 to 12 months. And then what would you maybe highlight beyond these programs that you're most [ as you ] start paying attention to?

And then just on the Affordable Medicines side, you guys have highlighted a significant pickup in demand for estrogen patches post the recent black box removal for those types of products. Maybe just walk us through how large is that market potential there? And how much is Amneal positioned to capture?

Chirag Patel: Great. I'll start with Affordable Medicines, the existing business, as I said, we're very -- the most excited since last 7 years. We used to be -- used to have this kind of excitement in -- from 2010 to 2018, and those times have come back. Existing -- the 2 reasons, the existing products, huge demand for the patches, estrogen patches, and we make them right here in New Jersey and expansion is underway 24/7. Our teams are working. We were fortunate to work with the equipment supplier to bring the equipment earlier, and we look to triple the capacity by next year. So it's a huge addition in revenue. Also, we are expanding lidocaine that is also in shortage.

So that demand is going up as well, the patches, hormonal -- I mean, sorry, the lidocaine patches. So with patches, with ophthalmics in high demand, with even the regular products being in a high demand and new product launches, Affordable Medicines could add -- it's a bigger range, but it could add $1 billion to $2 billion of new revenue from now to 2030. So that we are very excited with our existing pipeline, new product launches and the in-line products. So amazing times coming up in Affordable Medicines category. Biosimilars, we've spoken enough, a huge growth opportunity. Now let's -- in Specialty, CREXONT keep expanding, BREKIYA is breaking the records and UNITHROID is Steady-Eddie growth.

So we expect these 3 brands to continue to grow. On top of it, the organic pipeline would be revealed within probably in first quarter next year. And we will also look to be active in potential partnership, acquisitions of branded products that fits our commercial infrastructure and fits our -- the category we play in and we'll keep expanding, and we may add oncology assets as well, since we have the biosimilar oncology team already, more market knowledge over the last 3 years. So that's very exciting news on Specialty, and we look to share that as we have that information. On GLP-1 peptides, Pfizer's results are good on clinical trials and our partnerships moving extremely well.

We look to expand the partnership and our -- both plants are coming up as fast as they can and should be operational 2029 and '30, and we look to start supplying in 2030. And also, we have evaluated the markets that we are -- we have given the exclusive commercial rights like India and Egypt, and those are looking good as well. So very excited on a GLP-1 peptide opportunity. And also with this large infrastructure, it opens up for additional manufacturing of peptides as well as finished products for either other branded companies or in the future, some generics products.

Chintu Patel: On biosimilar, Matt, I just want to add in the next 6, 12 months, we are very much focused on integrating Kashiv and also advancing our pipeline on abatacept, Nplate and CIMZIA. Our goal is to -- because R&D is going to be key, and that's what Amneal is always shining. So Kashiv and enhanced R&D capabilities where we can file 3 or 4 biosimilars a year, which is potentially possible. And new into biologics, we are also looking into different platforms within the biologics and look at some new drug device combination within the biologics to come out with kind of a 505(b)(2) biosimilar. So we are just focused on biosimilars.

There are plenty of products to go advancing our pipeline and infrastructure and some of the 505(b)(2s) within the biosimilars.

Chirag Patel: Yes, I think we answered.

Operator: We have reached the end of the Q&A session. I will now turn the call back to Co-CEO, Chirag Patel, for closing remarks.

Chirag Patel: Well, thank you very much, everybody, and have a great Thursday. Take care.

Operator: This concludes today's call. Thank you for attending. You may now disconnect.

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