암닐 파마슈티컬스(AMRX) 2026년 3분기 실적 발표 콘퍼런스 콜: 가이던스 상향

핵심 요약

• 암닐 파마슈티컬스(Amneal Pharmaceuticals, AMRX)는 2026년 3분기 매출이 전년 동기 대비 10% 증가한 8억 6,300만 달러를 기록했다고 발표했습니다. 조정 EBITDA는 30% 증가한 2억 700만 달러, 조정 EPS는 53% 상승한 0.26달러를 기록했습니다.
• 보편적 의약품(Affordable Medicines) 부문 매출은 여성 건강용 경피 흡수 패치, 신제품 출시로 인한 5,400만 달러, 대형 바이오시밀러 고객사 주문의 시점상 수혜 약 4,000만 달러에 힘입어 전년 동기 대비 19% 증가한 5억 4,700만 달러를 기록했습니다.
• 전문의약품(Specialty) 부문 매출은 크렉손트(CREXONT), 브레키야(BREKIYA) 자가투여 주사기, 유니스로이드(UNITHROID)의 성장에 힘입어 20% 증가한 1억 5,000만 달러를 기록했습니다. 반면 에이브케어(AvKARE) 부문 매출은 전년 동기의 대규모 신제품 도입에 따른 기저효과로 17% 감소한 1억 6,500만 달러를 기록했습니다.
• 경영진은 2026년 연간 매출, 조정 EBITDA, 조정 EPS 가이던스를 상향 조정했습니다. 새로운 가이던스 범위는 각각 31억 5,000만~32억 5,000만 달러, 8억~8억 1,500만 달러, 1.04~1.08달러입니다.
• 회사는 카시브(Kashiv) 인수 작업을 완료하여 개발, 제조 및 상업화를 아우르는 통합 바이오시밀러 플랫폼을 구축했습니다. 경영진은 바이오시밀러가 2030년 매출 전망치인 43억~45억 달러 달성에서 가장 큰 성장 비중을 차지할 것으로 예상하고 있습니다.
• 9월 말 출시된 란레오티드(Lanreotide)는 약 700만 달러의 매출을 올렸습니다. 경영진은 4분기 매출이 이보다 수 배 더 높아질 것으로 예상하며, 장기적으로 30%~40%의 점유율을 목표로 하고 있습니다.

주요 재무 실적

연초 대비 누적으로는 매출이 8% 증가했고, 조정 EBITDA는 20%, 조정 EPS는 34% 성장했습니다.

사업 및 운영 실적

보편적 의약품 부문이 성장에 가장 크게 기여했습니다. 신제품이 분기 매출 5,400만 달러를 더했고, 대형 바이오시밀러 고객사의 주문이 시점상 수혜를 보며 약 4,000만 달러를 기여했습니다. 여성 건강용 경피 흡수 패치 역시 주요 성장 동력으로 유지되었으며, 경영진은 수요 대응을 위해 추가 생산 능력을 확충 중이라고 밝혔습니다.

9월 말 출시된 란레오티드는 3분기 실적 기여도가 미미했습니다. 그러나 초기 채택률이 호조를 보이고 있어 후속 분기에는 기여도가 확대될 것으로 회사는 전망했습니다. 암닐은 2026년 4분기 중 60mg 및 90mg 용량에 대한 승인 후 변경 신청(post-approval supplements)을 제출할 계획이며, 경영진은 2027년 하반기 출시를 목표로 하고 있습니다. 경영진에 따르면 현재 승인된 120mg 용량은 용량 기준 전체 시장의 약 90%를 차지합니다.

암닐은 또한 이오헥솔(iohexol) 포트폴리오를 확장했습니다. 회사는 모든 품목(SKU)의 허가 신청을 완료하고 생산 능력을 확충하는 한편 제품 공급망을 강화했다고 밝혔습니다. 경영진은 이오헥솔이 2027년의 핵심 성장 동력이 될 것으로 기대하고 있습니다.

전문의약품 부문의 크렉손트는 매달 약 400명의 신규 처방 의사를 계속 확보하고 있습니다. 경영진은 처방 성장이 장기 전망치의 중간에서 상단 수준을 뒷받침한다고 밝혔습니다. 브레키야는 2026년 당초 기대치의 약 2배 수준으로 추이하고 있으며, 경영진은 2027년 실적이 2026년 수준의 두 배에 달할 수 있다고 덧붙였습니다.

경영진에 따르면 카시브 인수 통합 작업이 순조롭게 진행되고 있습니다. 암닐은 이제 란레오티드 이익의 100%를 취하게 되었으며, 뉴저지 경제개발청(NJEDA)으로부터 6,000만 달러 규모의 세액 공제를 확보했습니다. 회사는 수익 배분 의무 해소 및 세제 혜택 확보를 통해 4억~5억 달러의 재무적 이익이 발생할 것이라는 기존 전망을 재확인했습니다.

화이자와의 협력을 위한 전용 GLP-1 원료의약품 및 완제의약품 생산 시설 건설은 2028년 완공을 목표로 차질 없이 진행 중입니다. 암닐은 이번 파트너십에 18개 시장에 대한 독점권이 포함되어 있으며, 양사가 향후 공동 마케팅 협약도 검토 중이라고 밝혔습니다.

경영진 가이던스

경영진은 영업활동 현금흐름 전망치가 낮아진 원인으로 수요 대응에 필요한 완제품 재고 증가와 2027년 1분기로 이월된 대금 회수 시점을 꼽았습니다.

카시브 인수 영향으로 3분기 말 순레버리지 비율은 조정 EBITDA 대비 3.5배를 기록했습니다. 경영진은 2026년 말 레버리지 비율을 3.6배로 예상하고 있으며, 2028년까지 3배 미만으로 낮출 수 있다는 자신감을 유지했습니다.

경영진은 2026년 약 31억~32억 달러 대비 2030년 매출 전망치를 43억~45억 달러로 재확인했습니다. 회사는 추가 성장의 대부분이 바이오시밀러를 필두로 한 보편적 의약품 부문에서 나올 것으로 예상합니다. 또한 경영진은 바이오시밀러 및 복합 제네릭의 비중 확대, 카시브 인수 실익 전액 귀속, 운영 효율화 등을 통해 매출총이익률이 개선될 것으로 기대하고 있습니다.

리스크 및 주요 관전 포인트

• 3분기 보편적 의약품 매출 중 약 4,000만 달러는 대형 바이오시밀러 고객사 주문의 시점상 수혜가 반영된 결과입니다.
• 영업활동 현금흐름 전망치는 재고 투자 및 대금 회수의 2027년 1분기 이월로 인해 하향 조정되었습니다.
• 에이브케어 매출은 수익성이 낮은 유통 사업의 우선순위를 낮추기로 한 결정의 영향이 지속되고 있으나, 경영진은 3분기 조정 EBITDA가 두 자릿수 성장률을 기록했다고 밝혔습니다.
• 암닐의 졸레어(XOLAIR) 바이오시밀러 출시 시점은 특허 합의 논의 결과에 달려 있습니다. 경영진은 현재 2027년 하반기 후반부 출시를 예상하고 있습니다.
• 카시브 인수 이후 순레버리지 비율이 상승했으며, 조정 EBITDA 대비 3배 미만으로의 디레버리징(부채 감축) 목표 시점은 즉각적인 달성이 아닌 2028년으로 설정되어 있습니다.

애널리스트 Q&A 주요 내용

경영진은 암닐의 졸레어 바이오시밀러가 셀트리온 제품에 이어 미국 시장에 두 번째로 진입하는 제품이 될 것으로 예상하며, 2027년 하반기 후반 출시 가능성을 보고 있습니다. 회사는 영국 허가를 획득했으며 유럽의약품청(EMA)의 긍정적 의견을 수령해 2026년 11월 말 유럽 최종 승인을 기대하고 있습니다.

란레오티드의 경우 암닐은 장기적으로 30%~40%의 점유율을 목표로 하고 있습니다. 회사는 해당 제품의 유럽 허가 신청도 완료했으며 2027년 3분기 규제당국의 조치를 기대하고 있으며, 미국과 유럽 수요 모두를 충족시킬 수 있는 생산 능력을 갖추고 있습니다.

경영진은 바이오시밀러가 2030년까지 매출 성장의 가장 큰 비중을 차지할 것이라고 밝혔습니다. 이 외에도 여성 건강 제품, 주사제(sterile injectables), 장기 지속형 주사제 프로그램, 흡입제, 안과 제품, 전문의약품 및 에이브케어의 정부 채널 확장 등이 성장 기여 요인으로 예상됩니다.

실적 발표 컨퍼런스 콜 전문

전체 실적 발표 컨퍼런스 콜 녹취록

경영진 발표

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.

Anthony DiMeo

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.

I will now hand the call over to Chirag.

Chirag Patel

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 have 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. 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 label 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.

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. 2 years after launch, CREXONT for Parkinson's disease continues to gain share. This is being driven by positive patient experience and compelling clinical evidence with more than 3 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 an 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, 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.

Chintu Patel

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 enable 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.

Also, 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 4 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.

First, in biosimilar, we now have the end-to-end capabilities from cell line and clone development through 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, run 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 to commercialization.

Our biosimilars manufacturing footprint in New Jersey and India is expanding, which enable 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. 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 2 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.

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 strength 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.

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 believe 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 injectable 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 onetime launch cycle. It reflects the innovation engine we have built over many years and the steady conversion of those programs into successful commercial launches.

Specifically, innovation is a new growth platform that we have been building. Last year, we received our first 2 approvals ProAir and QVAR. Looking ahead, we are targeting additional MDI and soft mist approvals over the next 3 years. We see innovation 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 treatment landscape. We are pursuing second Phase IV study evaluating its effect on disease progression as awareness and physician experience expand, the opportunity clearly 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 patients and disciplined execution. The progress made in 2026 and the catalysts ahead gives us very strong confidence heading into 2027.

With that, I will turn it over to Tasos.

Anastasios Konidaris

Thank you, Chintu. And good morning, everyone.

I'm 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 growth product portfolio as well as the fact that we play in large and growing markets. As a result, we're 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 3 channels of retail, injectables and government.

From a product perspective, growth was mainly driven by 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're 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 3 brands support continued growth into future years.

AvKare revenue was $165 million, down 17% as expected due to the nonrepeating nature of a large product introduction in the third quarter of last year, where revenue grew 25%. 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're very pleased to update our full year 2026 guidance. Revenues increased by $50 million at the midpoint of the new range of $3.15 billion to $3.25 billion. 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 3.5x adjusted EBITDA as of Q3, reflective of closing the Kashiv acquisition. We expect to finish 2026 at 3.6x adjusted EBITDA, in line with year-end 2025 and continue to feel confident of being below 3x 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'm happy to share 2 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. Large part of these benefits relates to the manufacturing expansion in support of the Kashiv acquisition and the future biosimilars product road map.

In summary, we're 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'll turn the call back to Chirag.

Chirag Patel

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 health care 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 #1 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. [Operator Instructions] Your first question is from Les Zalewski with Oppenheimer.

질의응답

Unknown Analyst

This is [ Jean ] on for Les.

Could you clarify the revenue book for lanreotide in 3Q? And what are you seeing on early metrics from initial stocking versus patient demand?

And then 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?

Anastasios Konidaris

This is Tasos. Number one is we launched lanreotide in Q3 actually, very late in September. The revenue was very small, about $7 million, right? You can expect multiple times of that in Q4. And as we think about kind of continued growth of the product throughout next year and beyond, our team is aiming at about 30% to 40% market share.

With that, let me pass it on to Chintu for part 2.

Chintu Patel

Yes. Thank you.

So on other 2 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.

Anastasios Konidaris

So most of the cells in these strengths.

Chintu Patel

Yes, the 90% of the strengths are in the 120-milligram strength.

Operator

Your next question is from David Amsellem with Piper Sandler.

David Amsellem

So on XOLAIR, can you talk about when in '27 you think you'll be in a position to launch? And just remind us what has to happen in order to be in a position to launch?

And then secondly, on XOLAIR, how are you thinking about competitive dynamics and how impactful it could be in '27 to the extent that you, say, one or 2 biosimilars on the market?

And 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?

Chirag Patel

XOLAIR, we have a goal date early next year, and we are in active discussion, which I cannot give you more detail on the patent settlement than a date, but we expect to launch in second half next year towards late and we on the competition side, as you know, Celltrion is in the market. We expect to be the second. And then Teva has filed the product as well.

It's an excellent molecule, large demand. We're already working with customer channels on various customer channels to maximize our opportunity there 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'll let you know when we strike. So very excited about XOLAIR.

Let's talk about BREKIYA. So BREKIYA, we're getting good 50%, 60% conversion, and it's a much needed drug. We're not getting too many payers blocked yet, so let the uptake happen and then we'll worry about the coverage. But right now, it's going through fine.

Operator

Your next question is from Chris Schott with JPMorgan.

Ekaterina Knyazkova

This is Ekaterina on for Chris.

So on your 2030 outlook, it seems like you're expecting very healthy top line growth. Just how much of that is coming from Affordable Medicines versus Specialty and AvKARE? And 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 that you're kind of embedding in that 2030 outlook?

And then second question is around [indiscernible] Women's Health. Just latest trends you're seeing for the product and your expectations for '27. How big can this become once you have some of the additional kind of capacity come online?

Anastasios Konidaris

I may have to repeat a couple of those questions. I'm fast, but you're 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's an incremental over $1 billion of growth. The majority of that growth is going to come from our Affordable Medicines space and primarily from Biosimilars, okay? That was a key impetus for the Kashiv acquisition

Now 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, but also you heard us a lot about the growing businesses such as women's health care 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 deprioritize 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're working closely with them about developing a strategic road map of biosimilars within the government channel. And that road map obviously is going to include Amneal products as well as other third parties. So I think that covers the revenue.

Can you just tell me what will be the other question around margins and maybe bottom line growth?

Ekaterina Knyazkova

Yes. 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?

Anastasios Konidaris

So great question. So one of the things that we have done over the last few years is focus on increasing our gross margins. So as an example, you can see our gross -- year-to-date as an example, Affordable gross margins are up 300 basis points as an example. And gross margin for the business this year, we're 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're going to improve further for a number of different reasons. Number one is as biosimilars in general, have a higher gross margin than the rest of our business, and with the acquisition of Kashiv, now we're able to keep all 100% of those economics. So that acquisition and Biosimilars being a key growth driver bodes well from a mix perspective, number one.

Number two, for many years now, we continue to focus on our complex generics for the Women's Health. So part of the reason we did that was, number one, is we saw a big market opportunity, number one; simply the competitive 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 busy kind of 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.

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

Chirag Patel

This is Chirag. I'm going to add a couple of things. So since we are talking about now to 2030, and I think for the overall for all the questions, I guess, this is very important. So 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're building out even more capacity. We are completely in the know of the demand. We're working with HHS and FDA as well. And we would provide you more details in our February call, but it's 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. If you can refer to the 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.

So 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're predicting that our base business will grow.

Second, we have the next wave, as my brother mentioned on his script, next wave of launches, which are all in Complex Gx. We're 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. And we're a purpose-driven company, correct? So we are partnering with hospitals to solve that supply from India and Brookhaven, New York.

Long-acting depot injections continue to gain traction. Risperidone, octreotide is coming, inhalation, we mentioned 2 approved, more are coming, ophthalmics ramping up. So no shortage of small molecule drugs coming up in next 4 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 that are fantastic and expect us to do more and more in Biosimilars.

Specialty is also growing because of continued growth of CREXONT. I mean we're probably not even halfway there, right? We keep growing the scripts.

And then AvKARE is growing on where it needs to grow high-growth areas such as Biosimilars, Specialty and Complex Gx, taking full advantage of our U.S. manufacturing capabilities.

And international grows because of the Biosimilars partnership internationally, we'll be doing more. India, we have launched our own label. Small business today will grow in the future. And we're further partnering in 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're extremely excited about from now to 2030.

Operator

Your next question is from Ash Verma with UBS.

Unknown Analyst

This is [ Bea ] on behalf of Ash. So one question from us.

For the iohexol, can you help us understand the overall opportunities and how that contributes to your '26 and '27 sales? And do you need the full SKU portfolio on the different dosing to maximize this launch? And then how is the conversation going with the IND on the contracting?

Chintu Patel

So on iohexol we now have filed all the SKUs and 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. So 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.

So 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.

Matthew Dellatorre

Congrats on the progress. Maybe 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 then also just how meaningful of an opportunity you think this could be to Amneal long-term?

And then on the Specialty side, I know you've pointed in the past to higher confidence in maybe the higher end of your long-term CREXONT and BREKIYA guidance. So just curious what your latest thinking was there.

Chintu Patel

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 and greatest lines, fully automated through the packaging inspection. It's amazing site, amazing partnership.

We will complete the construction in late '28 to '29, we should start commercialize for Pfizer in all territories basically. And 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're evaluating how do we market that with now Pfizer. We're interested in marketing a brand, not generic.

So that is where the Pfizer partnership and also those 2 sites we are building, we'll be able to take other business from other big pharma or even from Amneal Biologics, Kashiv's products, wherever it comes from amazing sites. So we're very excited to have this big potential, and we'll share more detail as we make great progress.

Chirag Patel

CREXONT and BREKIYA.

Chintu Patel

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

Joe Renda

Yes, absolutely. We're really, really pleased, Matt, with the response we've seen in the market with CREXONT. We continue to add new prescribers every month, around 400 or so we're adding monthly, and our TRxs are continuing to grow at a substantial pace. So we're very confident in the guidance we've given longer term, probably to the middle part, maybe even the higher end of that guidance based on our current trends. So we're very confident there.

And BREKIYA autoinjector, as we talked about earlier, the expansion that we did earlier this year has really enabled that product to really grow. We've already doubled the expectations for tracking of how we're performing this year. We anticipate next year to probably also come close to doubling our performance from this year. So 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.

And the per patient carton use also has also been a very substantial part of that accelerated growth with autoinjector. So we actually are very confident in that probably going beyond what our current expectations are from a guidance standpoint.

Operator

Your next question is from Daniel Clark with Leerink Partners.

Daniel Christopher Clark

Just wanted to ask how you're thinking about the lanreotide opportunity in Europe here. I believe you have a pending approval. But just curious if you could frame next steps and potentially how that could impact results?

Chintu Patel

Yes, we have filed our product in Europe, and we are expecting action in the third quarter next year. And 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.

Chirag Patel

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

Chintu Patel

Thank you.

Anthony DiMeo

Thanks everyone.

Operator

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