Amneal Pharmaceuticals Q3 2026 Earnings Call Transcript

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Provided by Quartr
November 3, 2026

Key Takeaways

  • Positive Sentiment: Strong Q3 performance: Revenue rose 10% to $863 million, adjusted EBITDA increased 30% to $207 million, and adjusted EPS grew 53% to $0.26, prompting Amneal to raise its 2026 revenue, EBITDA, and EPS guidance.
  • Positive Sentiment: Affordable medicines revenue increased 19% to $547 million, supported by women’s health transdermal patches, new product launches, and biosimilar orders. The recently launched lanreotide generated approximately $7 million in late-September sales, with management expecting substantially higher revenue in Q4 and targeting 30%–40% market share.
  • Positive Sentiment: The completed Kashiv acquisition gives Amneal integrated biosimilar development, manufacturing, and commercialization capabilities. Management expects $400 million–$500 million of financial benefits over time and recently secured $60 million in New Jersey tax credits tied largely to biosimilar-related expansion.
  • Positive Sentiment: Specialty products continued to gain momentum, with CREXONT adding approximately 400 prescribers monthly and BREKIYA tracking ahead of expectations. Management expressed confidence that both products could reach the middle to high end of its long-term outlook.
  • Negative Sentiment: Operating cash flow guidance was reduced by $25 million at the midpoint to $325 million–$375 million because Amneal is building finished-goods inventory to meet demand and expects some collections to shift into Q1 2027. Net leverage was 3.0 times adjusted EBITDA after the Kashiv acquisition, with year-end leverage expected to rise to 3.6 times.
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Earnings Conference Call
Amneal Pharmaceuticals Q3 2026
00:00 / 00:00

There are 12 speakers on the call.

Operator

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

Speaker 1

Good morning, and thank you for joining Amneal Pharmaceuticals Third Quarter 2026 Earnings Call. Today, we issued a press release reporting Q3 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.

Speaker 1

I will now hand the call over to Chirag.

Speaker 2

Thank you, Tony. Good morning, everyone. Today, Amneal is a stronger, more diversified company than ever before, with a portfolio focused on high-value products designed to drive durable growth. We've expanded across specialty, biosimilars, and complex products while building the capabilities and capacity to drive these businesses long term. 2026 marks our seventh consecutive year of top and bottom line growth, a track record that stands out in the industry. Our third quarter performance reflects that progress, with revenue of $863 million, up 10%, adjusted EBITDA of $207 million, up 30%, and adjusted EPS of $0.26, up 53%. The breadth of our portfolio and the depth of our pipeline give us confidence that we are still early in realizing Amneal's full potential. Let me highlight the progress across our key growth areas. First, in biosimilars, we closed the Kashiv transaction in Q3.

Speaker 2

Amneal now has the end-to-end capabilities to succeed in biosimilars, R&D, manufacturing, and commercial in-house. Now it is all about execution. From a macro perspective, we have access to a large and growing biosimilar market with approximately $234 billion of U.S. biologic sales losing exclusivity over the next decade. At the same time, streamlined regulatory pathways, new commercial models such as private labels, and accelerating market adoption are creating a major inflection point for the U.S. biosimilar industry. Against this backdrop, our portfolio strategy is deliberately differentiated, balancing targeted lower competition molecules with a select number of broader biologic opportunities. We believe this approach positions Amneal to capture attractive economics and sustain long-term value creation. For Amneal, biosimilars are a natural extension of our purpose, making key medicines more accessible and affordable while building a durable growth platform.

Speaker 2

Biologics accounts for more than half of U.S. drug spending, yet represents only 5% of total prescriptions, highlighting the significant affordability and access challenge. We believe we can help address that gap and create value for patients. Second, complex generics remains a core strength with a proven track record of execution. We have an expanding diversified portfolio of high-demand complex therapies, including women's health, transdermal patches, and important new injectable products approvals such as lanreotide, romidepsin, and iohexol. Across dosage forms, these are significant opportunities for sustained growth. We have strategically evolved our portfolio toward high-value complex products where our science, manufacturing capabilities and capacity, reliable supply, and customer relationships set us apart. Third, in specialty, our key brands are performing very well. Two years after launch, CREXONT for Parkinson's disease continues to gain share.

Speaker 2

This is being driven by positive patient experience and compelling clinical evidence with more than three additional hours of good on time per day versus other therapies. BREKIYA is also gaining strong traction in migraine and cluster headache, performing ahead of our expectations this year. We see our specialty segment becoming considerably large over time. Fourth, AvKARE remains important aspect of our business that provides diversification and access to government and institutional channels for our high-value products, including biosimilars in the future. Fifth, we are advancing our GLP-1 collaboration with Pfizer, as construction of our new dedicated GLP-1 manufacturing facilities for both drug substance and drug product remain on track for 2028. Taken together, Amneal has a fundamentally stronger and more diversified growth profile than ever before, with more growth engines, more innovation, and more opportunities ahead.

Speaker 2

Our focus is on the execution, delivering across each of these areas, converting that potential into results. We believe the momentum of 2026 positions us very well for continued high growth in 2027 and beyond. With that, I'll turn it over to Chintu.

Speaker 3

Thank you, Chirag, and good morning, everyone. I want to thank the entire Amneal team, which continues to execute at a high level. Their strong performance enables us to pursue increasingly ambitious opportunities while continuing to deliver across our existing businesses. Since our last call, we closed the Kashiv transaction in August. The combined team is working as one across development, manufacturing, and commercialization to build our biosimilar business. As we shared on our Q2 call, one of our India facilities experienced flooding back in late July. The team worked tirelessly to limit the impact, and we are pleased to share that operations have fully resumed. In addition, in September, we received FDA approval for lanreotide, a high-value complex injectable. Let me focus on four areas. First, integrating Kashiv and advancing our biosimilar pipeline. Second, our global operational strategy. Third, our R&D portfolio. And fourth, growing our specialty business.

Speaker 3

First, in biosimilar, we now have the end-to-end capabilities, from cell line and clone development to clinical execution, regulatory expertise, biologics manufacturing, and commercialization. Kashiv brings the science, development, and biologics manufacturing, while Amneal brings commercial scale, channel expertise, and customer relationships. Together, we can move faster, plan effectively, and capture more value, reinforcing biosimilars as a key long-term growth pillar for Amneal. The combined platform is designed to make disciplined portfolio decisions, advance multiple molecules in parallel, and create a repeatable path from R&D through commercialization. Our biosimilars manufacturing footprint in New Jersey and India is expanding, which enables us to work on a growing number of biosimilar R&D programs and also meet commercial demand. Our biosimilars pipeline is focused on early-to-market global opportunities, where we are targeting being first or second to launch.

Speaker 3

We built this playbook and executed it well in complex generics, and we are now applying it to biosimilars. Second, in operations, our priorities remain clear: quality, reliability, and resiliency. Across our global manufacturing and supply chain network, we continue to deepen our capabilities and capacity in complex generics, sterile injectables, and biosimilars. Our facilities have transformed in recent years through digitization, automation, and AI-enabled tools. We are advancing our manufacturing capabilities and quality while improving efficiency. At the same time, we are scaling capacity for our key growth areas, including significant expansion for women's health transdermal patches this year, new U.S. sterile injectable capabilities by 2028, expanding our complex injectable capacity for key programs like lanreotide and risperidone, building out our two new GLP-1 facilities, and increasing biosimilar capacity to support our pipeline. These initiatives are designed to meet increasing market demand and drive meaningful new growth.

Speaker 3

This broad operational platform is differentiated in the industry. Our large manufacturing footprint across 20 global facilities and technical expertise position Amneal well to deliver reliable supply, address important market needs, and pursue new growth opportunities at the same time. Third, turning to our complex generics pipeline, we continue to convert many years of R&D hard work into significant commercial products. Complex generics build this company, and we are not slowing down. That strategy is visible in the differentiated portfolio, spanning injectables, ophthalmics, inhalation, transdermal, drug device combinations, 505(b)(2) products, and other dosage forms. Recent approvals are important proof points. Recent approvals include key complex generics and 505(b)(2) products, such as lanreotide, romidepsin RTU, sodium bicarbonate IV bag, and additional strengths and presentations of iohexol. These products expand our portfolio into large, attractive markets and demonstrate our ability to develop, manufacture, and commercialize increasingly complex medicines in-house.

Speaker 3

Looking ahead, we are advancing a deep pipeline of long-acting injectable, 505(b)(2), and inhalation programs. We continue to have the most CGT approvals in the U.S. pharmaceutical industry. One year ago, on our Q3 call, we highlighted 20 key launches across 2025 and 2026 that we believed would propel our affordable medicines business to a new level. Today, almost all are now approved and launched. Looking forward, we see a next wave of new product launch opportunities between 2027 and 2029, particularly new sterile injectables and bag products. This gives us high confidence that growth in affordable medicines will continue to stay elevated in the years ahead. Importantly, this is not a one-time launch cycle. It reflects the innovation engine we have built over many years and the steady conversion of those programs into successful commercial launches.

Speaker 3

Specifically, inhalation is a new growth platform that we have been building. Last year, we received our first two approvals, PROAIR and QVAR. Looking ahead, we are targeting five additional MDI and soft mist approvals over the next three years. We see inhalation as a new vector of growth for the business. Fourth, in specialty, we are very pleased with the continued performance of CREXONT and BREKIYA. The strength is visible not only in higher revenues, but also in prescription trends, physician adoption, and the growing number of patients benefiting from these impactful therapies. For CREXONT, we continue to build on the clinical and real-world evidence supporting its differentiated profile in Parkinson's disease treatment landscape. We are pursuing second phase IV study, evaluating its effect on disease progression.

Speaker 3

As awareness and physician experience expand, the opportunity remains clear to expand CREXONT's reach among the 700,000 patients in the U.S. on carbidopa-levodopa therapy. Beyond CREXONT and BREKIYA, we are advancing additional 505(b)(2) and novel R&D programs to build a broader specialty platform focused on differentiated medicines that improve patient outcomes. Across our businesses, our formula remains the same: strong science, quality first, robust planning, care for customers and patient, and disciplined execution. The progress made in 2026 and the catalyst ahead gives us very strong confidence heading into 2027. With that, I will turn it over to Tasos.

Speaker 4

Thank you, Chintu, and good morning, everyone. I am very pleased to share our third quarter exceptional financial results, which are a testament to our strategic choices and strength of execution. Revenue of $863 million increased 10%, adjusted EBITDA of $207 million increased 30%, and adjusted EPS of $0.26 increased 53%. Our growth profile remains very strong due to the relevancy and complexity of our broad product portfolio, as well as the fact that we play in large and growing markets. As a result, we are very pleased to once again increase our 2026 financial guidance and expect strong momentum in 2027 and beyond. In the third quarter, affordable medicines delivered revenue of $547 million and grew 19%. This reflects growth across our three channels of retail, injectables, and government.

Speaker 4

From a product perspective, growth was mainly driven by our women's health transdermal patches, new product launches, which added $54 million in the quarter, and favorable timing of a large biosimilar customer order, which added about $40 million. It is worth noting that lanreotide made a very small contribution in Q3, as we launched in late September. However, we are already seeing terrific uptake and expect much larger contribution of lanreotide in subsequent quarters as we fulfill substantial market demand. Specialty revenue was $150 million, up 20%, driven by continued growth across CREXONT, BREKIYA autoinjector, and UNITHROID. Strong underlying trends and smart execution across these three brands support continued growth into future years. AvKARE revenue was $165 million, down 17%, as expected, due to the non-repeating nature of a large product introduction in the third quarter of last year, where revenue grew 25%.

Speaker 4

Putting this one factor aside, AvKARE revenue in the quarter was stable, while adjusted EBITDA was up double digits as our team continues to prioritize profitability over simple revenue growth. Moving down the P&L, Q3 adjusted gross margin was 43.2%, up 50 basis points year-over-year, reflecting favorable mix. Adjusted EBITDA grew 30% due to strong revenue growth and disciplined expense management. Q3 adjusted EPS grew 53%, reflecting higher adjusted EBITDA and lower interest expense. It is important to note that our year-to-date financial performance is also extremely strong, with revenues up 8%, adjusted EBITDA up 20%, and adjusted EPS up 34%. As a result, we are very pleased to update our full year 2026 guidance. Revenue is increased by $50 million at the midpoint of the new range of $3.15 billion to $3.25 billion.

Speaker 4

Adjusted EBITDA is increased by $43 million at the midpoint of the new range between $800 million and $815 million. Adjusted EPS is also increased by $0.05 at the midpoint of the new range of $1.04 and $1.08. Finally, operating cash flow is slightly down by $25 million at the midpoint of the new range of $325 million to $375 million. The operating cash flow adjustment is driven by timing and reflects our decision to increase internal finished goods inventory to satisfy strong revenue demand and timing of some collections being pushed to Q1 of 2027. From a balance sheet perspective, net leverage was 3.0 times adjusted EBITDA as of Q3, reflective of closing the Kashiv acquisition.

Speaker 4

We expect to finish 2026 at 3.6 times adjusted EBITDA, in line with year-end 2025, and continue to feel confident of being below 3 times adjusted EBITDA by 2028. Let me now finish with our Kashiv acquisition, where the integration is progressing very well. As you may recall, in addition to the large market opportunity this deal represented, we also highlighted $400 million to $500 million in expected financial benefits driven by elimination of profit-sharing obligations and various tax incentives. We feel very confident about capturing these benefits, and I am happy to share two recent proof points. First, our newly launched product, lanreotide, was originated at Kashiv, and as a result of the acquisition, Amneal now gets to keep 100% of this product's profits. Second, last week, we secured $60 million in tax credits from the New Jersey Economic Development Authority.

Speaker 4

Large part of these benefits relates to the manufacturing expansion in support of the Kashiv acquisition and the future biosimilars product roadmap. In summary, we are extremely pleased with our strong results, increased financial outlook for 2026, and the strong momentum for continued growth in 2027 and beyond. With that, I will turn the call back to Chirag.

Speaker 2

Thank you, Tasos. Our Q3 results reflect the breadth and depth of Amneal. We are executing well across our growth pillars, complex generics, biosimilars, specialty, and AvKARE, with GLP-1 continue to advance very well. Since our last call, we closed the Kashiv transaction to create an integrated biosimilars platform. We received important approvals, including lanreotide, and our specialty brands, CREXONT and BREKIYA, continue to drive uptake. These are tangible achievements, and there is more ahead. The strength we are delivering in 2026, combined with our upcoming catalysts and pipeline, gives us confidence in continued strong growth in 2027 and beyond. Our goal remains clear, to become America's number one affordable medicines company and a leading provider of essential medicines globally. With that, let's open the call for Q&A.

Operator

We will now begin the question and answer session. Please limit yourself to one question and one follow-up. If you would like to ask a question, please press star one to raise your hand. To withdraw your question, press star one again. We ask that you pick up your handset when asking a question to allow for optimum sound quality. If you are muted locally, please remember to unmute your device. Please stand by while we compile the Q&A roster. Your first question is from Les Sulewski with Oppenheimer. Your line is now open. Please go ahead.

Speaker 5

Hey, this is Jeevan on for Les. Thanks for taking our questions. Could you clarify the revenue book for lanreotide in 3Q, and what are you seeing on early metrics from initial stocking versus patient demand? As a follow-up, I think the FDA only approved the 120 milligram syringe. Are the 60 and 90 milligram strengths filed, and when could they be approved? Thank you.

Speaker 4

Yeah. Gene, this is Tasos. Welcome. Number one is, we launched the 300 lanreotide in Q3, actually, very late in September. The revenue was very small, about $7 million. You can expect multiple times of that in Q4. As we think about continued growth of the product throughout next year and beyond, our team is aiming at about 30%-40% market share. With that, let me pass it on to Chintu for part two.

Speaker 3

Yeah. Thank you. On other two strengths, 60 and 90, our post-approval supplement is ready, and we will be filing both the strengths in this quarter and expect the launch in the second half of next year.

Speaker 2

Most of the sales in this strength.

Speaker 3

Yeah, 90% of the sales are in the 120 milligram strength. Yeah.

Speaker 4

Thank you, Chintu.

Speaker 3

Thank you.

Operator

Your next question is from David Amsellem with Piper Sandler. Your line is now open. Please go ahead.

Speaker 6

Hey, thanks. On XOLAIR, can you talk about when in 2027 you think you'll be in a position to launch? Just remind us what has to happen in order to be in a position to launch. Then secondly, on XOLAIR, how are you thinking about competitive dynamics and how impactful it could be in 2027 to the extent that you say one or two biosimilars on the market? Then just another quick question on BREKIYA, that seems to be ramping nicely. Can you talk about access dynamics and how you're thinking about the trajectory of that product going forward? Thanks.

Speaker 2

David, good morning. XOLAIR, we have a goal date early next year, and we are in active discussion, which I cannot give you more detail, on a patent settlement and a date. We expect to launch in second half next year, towards late. On the competition side, as you know, Celltrion is in the market. We expect to be the second. Teva has filed the product as well. It is an excellent molecule, large demand. We are already working with customer channels on various customer channels to maximize our opportunity here for years to come, as well as we have the approval in MHRA and a positive opinion from EMA for XOLAIR, which we expect the final approval in late November, and launch again according to the patent settlement, which we will let you know when we strike. Very excited about XOLAIR. Let us talk about BREKIYA.

Speaker 2

BREKIYA, we are getting good 50%, 60% conversion, and it is a much needed drug. We are not getting too many payers blocked yet, so let the uptake happen, and then we will worry about the coverage. Right now, it is going through fine. Thank you.

Speaker 6

Thanks.

Operator

Your next question is from Chris Schott with J.P. Morgan. Your line is now open. Please go ahead.

Speaker 7

Thanks so much. This is Ekaterina on for Chris. On your 2030 outlook, it seems like you are expecting very healthy top line growth. Just how much of that is coming from affordable medicines versus specialty and AvKARE? Then can you help us also bridge from the top line to your EPS number? Just any key assumptions in terms of margins or anything like that you are kind of embedding in that 2030 outlook. Then second question is around Dodie and women's health. Just latest trends you are seeing for the product and your expectations for 2027. How big can this become once you have some of the additional kind of capacity come online? Thanks.

Speaker 4

Tasos, you take this one. Hey, Ekaterina. Good morning. You may have to repeat a couple of those questions. I am fast, but you are even faster than me. As we think about 2030, just to kind of ground everyone, what we said was we expect the revenue to go from about $3.1 billion this year, right, $3.1 billion to $3.2 billion, to about $4.3 billion to $4.5 billion. So that is an incremental over a billion dollars of growth. The majority of that growth is going to come from our affordable medicines space, and primarily from biosimilars. That was a key impetus for us to kind of, for the Kashiv acquisitions. Since we announced, the biggest majority of that calling, as I said before, is going to come from affordable medicines, and within affordable medicines, biggest chunk biosimilars.

Speaker 4

You heard us a lot about the growing businesses such as women healthcare, transdermal patches that are growing, as well around our injectable business. So those are the other components within affordable medicines that we expect to grow. AvKARE, we expect that will continue to grow. I think we had this year a little bit of a reset from a revenue perspective, as we did prioritize our low margin distribution channel. But adjusted EBITDA is up 26% this year, just to kind of give you a flavor. So we continue to see a huge runway of AvKARE, primarily as they enter play bigger player within the government channel and passing through more biosimilar products. So we are working closely with them about developing a strategic roadmap of biosimilars within the government channel, and that roadmap obviously is going to include Amneal products as well as other third parties.

Speaker 4

I think that covers the revenue. Can you just tell me what were the other question around margins and maybe bottom line growth?

Speaker 7

Yeah, just kind of what are you embedding in just in terms of gross margins and any other kind of key assumptions as you kind of think about bridging from the revenue to the EPS?

Speaker 4

Great. So great question. One of the things that we have done over the last few years is focus on increasing our gross margins. As an example, you can see our year-to-date as an example. Amneal gross margins are up 300 basis points as an example. And gross margin for the business this year, we are probably going to be total Amneal probably at about 46.5% compared to about 45.5% last year. So solid growth rate in terms of gross margins. As we think about 2030, gross margins will improve further, and they are going to improve further for a number of different reasons. Number one is, biosimilars in general have a higher gross margin than the rest of our business, and with the acquisition of Kashiv, now we are able to keep all 100% of those economics.

Speaker 4

That acquisition and biosimilars being a key growth driver bodes well from a mixed perspective, number one. Number two, for many years now, we continue to focus on our complex generics, Amneal medicines. Part of the reason we did that was, number one, we saw a big market opportunity, number one. Simply the comparative dynamics in that space is better. And number three, the average price point and profitability for those products is higher than what will be for a typical oral generic. And the third thing is, our teams work day and night to continue to drive operating efficiencies. So everyone is basically doing more with less and increasing our efficiency rates, and there is a lot of internal effort that our CEOs are leading in terms of embedding AI more and more in our day-to-day operations.

Speaker 4

Over the course of time, as we think about 2030, we see revenue growth accelerating, margins continue to improve, and this is what is going to drive substantial bottom line growth rates as well as reducing debt over the course of time.

Speaker 2

Great, Tasos. Chirag, I am going to add a couple of things. Since we are talking about now to 2030, then I think it for the overall, for all the questions, I guess, this is very important. Our base business is growing actually. So we are very excited due to the women's health HRT, we have built out the capacity. We are building out even more capacity. We are completely in the know of the demand. We are working with HHS and FDA as well. And we would provide you more details in our February call, but it is a significant opportunity. And we are fulfilling a key need out there on women's health. So day and night work has been done by our Piscataway, New Jersey team, and expansion has already happened, and more is coming. So significant opportunity in the base business, which we never had it before.

Speaker 2

You can refer to slide 5 in our presentation that shows you that $1.2 billion of revenue on a base business in 2019 has only gone down by $200 million to $1 billion this year. There is no such thing as leaky buckets on these products. These are needed products. Some goes down, some go up, 300 products portfolio. Now, we are predicting that our base business will grow. Second, we have next wave, as my brother mentioned on his script, next wave of launches, which are all in complex generics. We are building out a sterile manufacturing facility in New York. We got a PreCheck program. We are converting the compounded drug into approved products. Such a big need for the hospitals. We are a purpose-driven company, correct? We are partnering with hospitals to solve that supply from India and Brookhaven, New York.

Speaker 2

Long-acting depot injections continue to gain traction. Risperidone, octreotide is coming. Inhalation, we mentioned two approved, more are coming. Ophthalmic is ramping up. So no shortage of small molecule drugs coming up in next four years. Biosimilars on top of that are also coming. Excited about launching denosumab, both presentation in mid-next year, then XOLAIR, and then continue to, we have disclosed some of the pipeline assets. They are fantastic, and expect us to do more and more in biosimilars. Specialty is also growing because of continued growth of CREXONT. We are probably not even halfway there, Joe, right? We will keep growing the scripts. AvKARE is growing on where it needs to grow high growth areas such as biosimilars, specialty, and complex generics, taking full advantage of our U.S. manufacturing capabilities.

Speaker 3

International grows because of the biosimilars partnership internationally. We will be doing more. India, we have launched our own label. Small business today will grow in the future, and we are partnering in, and more further partnering South America, Europe, Middle East, Canada. So international, which today is only $40 million-$50 million business, expect to grow significantly as well. So we are extremely excited about from now to 2030.

Operator

Your next question is from Ash Verma with UBS. Your line is now open. Please go ahead.

Speaker 8

Hey, good morning. This is Bea on behalf of Ash. One question from us. For the iohexol, can you help us understand the overall opportunities and how that contributes to your 2026 and 2027 sales? Do you need the full SKU portfolio on the different dosing to maximize this launch? How is the conversation going with the IDN on the contracting? Thank you.

Speaker 3

On iohexol, we now have filed all the SKUs, and we will be covering the entire breadth of the iohexol product. It is a complex product. Still, we are the only generic. We work very hard to increase our capacity and the cost efficiency. Going into 2027, we feel pretty good about iohexol as being a key growth driver, and our commercial teams are working with hospitals and other channels to increase our market share with having the full basket. The iohexol would be a good product for us as we have the more capacity, all the SKUs, and we have strong resilient supply chain now on iohexol.

Operator

Your next question is from Matt Dellatorre from Goldman Sachs. Your line is now open. Please go ahead.

Speaker 9

Great. Thanks for the questions, and congrats on the progress. On the Pfizer partnership, could you just give us an update on the status of that, and share any more color on development progress, manufacturing preparedness, and also kind of how meaningful of an opportunity this could be to Amneal long term? On the specialty side, I know you have pointed in the past to higher confidence and maybe the higher end of your long-term CREXONT and BREKIYA guidance. Just curious what your latest thinking was there. Thanks so much.

Speaker 3

Good morning, Matt. How are you? Pfizer, excellent partnership, going really well. Both teams are doing fantastic. They just had 12 people visiting our facilities, which are under construction. They are awestruck by how awesome it is, fully digitized, AI-based. The capacity is huge, obviously. It is latest and greatest lines, fully automated through the packaging, inspection. It is amazing site, amazing partnership. We will complete the construction in late 2028 to 2029. We should start commercialize for Pfizer in their territory, all territories basically. We are working through the final touches of how the future partnership would look like on our co-marketing. We have given access to 18 markets exclusively, so we are evaluating how do we market that with now Pfizer. We are interested in marketing a brand, not generic.

Speaker 3

That is where the Pfizer partnership and also those two sites we are building will be able to take other business from other big pharma or even from Amneal Biosciences, Kashiv's products, wherever it comes from. Amazing site. So we are very excited to have this big potential, and we will share more detail as we make great progress. What was the second?

Speaker 10

CREXONT and BREKIYA.

Speaker 3

CREXONT and BREKIYA. Joey, would you like to chime in?

Speaker 10

Yeah, absolutely. We are really, really pleased, Matt, with the response we have seen in the market with CREXONT. We continue to add new prescribers every month, around 400 or so we are adding in monthly, and our TRXs are continuing to grow at a substantial pace. We are very confident in the guidance we have given longer term, probably to the middle part or maybe even the higher end of that guidance based on our current trends. We are very confident there. BREKIYA autoinjector, as we talked about earlier, the expansion that we did earlier this year has really enabled that product to really grow. We have already doubled the expectations for the tracking of how we are performing this year. We anticipate next year to probably also come close to doubling our performance from this year.

Speaker 10

The response from the market for BREKIYA autoinjector has been very positive, and the expansion, as I mentioned, that we did enables us to get into more of the key headache prescribers that have been very, very responsive so far. The per-patient carton use also has also been a very substantial part of that accelerated growth with BREKIYA autoinjector. We actually are very confident in that, probably going beyond what our current expectations are from a guidance standpoint.

Speaker 9

Great. Thanks for all the color.

Speaker 10

Great. Thank you, Matt.

Operator

Your next question is from Daniel Clark with Leerink Partners. Your line is now open. Please go ahead.

Speaker 11

Great. Thank you. Good morning. Just wanted to ask how you are thinking about the lanreotide opportunity in Europe here. I believe you have a pending approval. So just curious if you could frame next steps and potentially how that could impact results. Thank you.

Speaker 3

Yeah. Hi, Daniel. Good morning. Yes, we have filed our product in Europe, and we are expecting action in the third quarter next year. We have built capacity to address both the U.S. demand and Europe. It is a substantial product and volume in Europe, so we are very excited about the European opportunity also.

Operator

There are no further questions at this time, and we have reached the end of the Q&A session. I will now turn the call back to Chirag Patel for closing remarks.

Speaker 3

Well, thank you everybody for listening. Have a great day. Thank you.

Speaker 10

Thank you.

Operator

This concludes.

Speaker 3

Thanks, everyone.

Operator

today's call. Thank you so much for attending. You may now disconnect.

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