What are your thoughts on recent tariff headlines and potential impact? What trends are you seeing in CREXONT uptake?

Amneal has extensive U.S. manufacturing and will collaborate with the administration on tariffs. For CREXONT, 80% of scripts are from general neurologists, which is a positive trend, and Phase IV data is well-received, driving continued script growth. “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.”

Can you quantify the opportunity for iohexol and lanreotide, and how long they might remain limited competition? What is your appetite for adding Specialty assets, particularly in neurology?

Iohexol is a $50M+ opportunity, with additional SKUs expected by year-end and meaningful revenue in FY27. Lanreotide is a complex product with high barriers to entry, and Amneal expects to be a market leader upon Q3 launch. The company will focus on CNS and oncology assets for Specialty M&A, leveraging existing infrastructure. “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.”

Are there any gating items from the FDA for lanreotide approval, given the Q3 launch reiteration? Is iohexol adoption contingent on having all SKUs, or can meaningful revenue start now?

Amneal is optimistic about lanreotide's Q3 launch, having responded to all FDA queries with no negative feedback. For iohexol, while not strictly necessary, the strategy is to have all SKUs for a larger market share, with meaningful revenue expected in FY27 rather than FY26. “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.”

AMRX

Amneal (AMRX) Q2 FY26 earnings call: guidance and Q&A

Earnings call· Jun 2026 (Q2 FY26)· Health Care· Jul 30, 2026

Source: earnings call transcript

Executive summary

Amneal Q2 FY26 — Strong Performance, Raised Outlook, and Strategic Transformation

Amneal Pharmaceuticals delivered strong Q2 FY26 results, driven by momentum in Affordable Medicines and Specialty segments, leading to a raised full-year outlook. The company is undergoing a transformative period, focusing on biosimilars through the Kashiv acquisition, expanding its complex generics portfolio, and advancing its Specialty pipeline, including a GLP-1 partnership, to become a leader in affordable and essential medicines.

Highlights

Total net revenue grew 10% year-over-year to $796 million.
Adjusted EBITDA increased 12% year-over-year to $206 million.
Adjusted EPS rose 20% year-over-year to $0.30.
Full-year 2026 revenue outlook raised by $50 million to $3.1 billion - $3.2 billion.
Full-year 2026 adjusted EBITDA guidance raised by $10 million to $750 million - $780 million.

Concerns

AvKARE revenue decreased 4% year-over-year to $157 million, due to the low-margin distribution business.
India facility flood is estimated to have a $20 million negative impact on full-year 2026 guidance.

Guidance & targets

Category	Target	Timeline	Confidence
Full-year 2026 Total Net Revenue	$3.1 billion to $3.2 billion high materiality	FY26	High
Full-year 2026 Adjusted EBITDA	$750 million to $780 million high materiality	FY26	High
Full-year 2026 Adjusted EPS	$0.96 to $1.06 high materiality	FY26	High
Full-year 2026 Capital Expenditure	~$150 million medium materiality	FY26	High
Full-year 2026 Operating Cash Flow	Maintained medium materiality	FY26	High
Net Leverage Ratio	Below 3x high materiality	FY28	High
Lanreotide Launch Timing	Q3 FY26 high materiality	Q3 · FY26	High
XOLAIR Biosimilar Launch Timing	Very late end of FY26 or early FY27 high materiality	FY26/FY27	Medium
Kashiv Drug Substance Capacity Expansion	~75,000 liters medium materiality	FY28	High
Biosimilar Filings per Year	3-4 biosimilars a year medium materiality	Ongoing	Medium
Affordable Medicines New Revenue	$1 billion to $2 billion high materiality	Now to 2030 · FY30	High
Estrogen Patch Capacity	Triple capacity medium materiality	Next year · FY27	High
GLP-1 Supply Operational Timing	2029 and '30 high materiality	CY29-CY30	High
GLP-1 Supply Start	2030 high materiality	CY30	High

Segment performance

Segment	Revenue	YoY	QoQ	Margin
Affordable Medicines Reflecting the strength of the broad-based complex portfolio, including Women's Health products, injectables, and higher naloxone sales. New product launches contribution to Q2 revenue: $45 million	$490 million	13%	—	—
Specialty Driven by continued momentum in CREXONT, UNITHROID, and BREKIYA, all ahead of expectations.	$149 million	17%	—	—
AvKARE Growth in the government channel was offset by the low-margin distribution business.	$157 million	-4%	—	—

Deals & partnerships

Kashiv BioSciences Acquisition to build a fully integrated global biosimilar platform, spanning development to commercial supply.

Adds in-house biologics capabilities, including cell line and clone development, protein characterization, process development, clinical execution, regulatory expertise, and scaled biologics manufacturing in India and U.S. Expected to close pending shareholder vote and closing conditions.

Pfizer Partnership for GLP-1 peptides.

Partnership is moving extremely well, with plans to expand. Both manufacturing plants are expected to be operational in 2029 and 2030, with supply starting in 2030. Exclusive commercial rights in markets like India and Egypt are looking good.

Risks & headwinds

India facility flood impact Full-year 2026

$20 million negative impact

Mitigation:Expect to resume operation within the next few weeks; limited impact on select products.

AvKARE low-margin distribution business Q2 FY26

Revenue down 4% year-over-year

Mitigation:Company remains focused on the unique value in the government channel and expanding profitability.

What to watch in Q3 FY26

Lanreotide Approval and Launch

Q3 FY26

Current Official goal date in Q3 FY26

Target Approval and commercial launch

Why it matters

This is a high-value, complex generic with significant market potential and high barriers to entry, expected to be a meaningful growth driver.

So, lanreotide is on its way. That's what we feel as of today. It has official goal date in Q3.

Find out whether AMRX delivers this. Inve re-checks your case every morning.

Q&A highlights

What is the expected timing for lanreotide and XOLAIR biosimilar launches, and what is included in the H2 FY26 guidance? Can you update on the 6 commercial biosimilars by 2027 and which will be most meaningful?

Lanreotide is expected in Q3 FY26 with conservative forecast included. XOLAIR biosimilar is late FY26 or early FY27, with no revenue included for this year. The 6 commercial biosimilars by 2027 include existing ALYMSYS, RELEUKO, FYLNETRA, plus upcoming Prolia, XGEVA, and XOLAIR.

“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... 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.”

asked by Glen Santangelo · answered by Chirag Patel

2 min read 6 chapters

Detailed narrative

Strategic Transformation and Growth Drivers

Amneal is undergoing a significant transformative period, aiming to become a leading provider of affordable medicines. The company is focused on diversifying its portfolio across Specialty brands, biosimilars, GLP-1s, and complex generics. This strategy leverages Amneal's strong R&D, manufacturing, and commercial capabilities to expand patient access and affordability, driving sustained momentum and growth.

Biosimilars Platform Expansion with Kashiv Acquisition

The pending acquisition of Kashiv is a cornerstone of Amneal's strategy to build a fully integrated global biosimilar platform. This integration will provide end-to-end capabilities from cell line development to commercial supply, positioning Amneal to capitalize on the upcoming wave of biologics losing exclusivity. The combined pipeline includes over 20 biosimilar programs, with significant opportunities identified for XOLAIR, ORENCIA, CIMZIA, and Nplate.

Affordable Medicines Momentum and Pipeline

Amneal's base Affordable Medicines business demonstrates strong resilience and growth, driven by high demand for transdermal patches, including Women's Health products and lidocaine, and injectables. The company's pipeline is concentrated on high-value, complex generics such as lanreotide and iohexol. Amneal plans 12-15 high-value complex ANDA filings this year, including metered-dose inhalation products, reflecting a deliberate strategy to prioritize technically challenging dosage forms.

Specialty Portfolio Performance and Future Expansion

The Specialty segment continues its strong performance, with CREXONT for Parkinson's disease gaining significant traction, supported by compelling Phase IV data. BREKIYA is also experiencing robust uptake for migraine and cluster headaches. Amneal plans to expand its Specialty pipeline through internal R&D and potential M&A, particularly in CNS and oncology assets, leveraging its established commercial infrastructure.

Manufacturing and Supply Chain Resilience

Amneal emphasizes its global, high-quality manufacturing and supply chain capabilities, enhanced by digitization, automation, and AI tools. The company's Brookhaven, NY site was selected for the FDA's PreCheck Pilot Program, acknowledging its robust U.S. manufacturing and efforts to strengthen supply chain resiliency, especially for sterile injectables. This focus ensures reliable, high-quality supply and addresses market needs and drug shortages.

Financial Performance and Outlook

The second quarter saw strong financial performance with double-digit growth in revenue, adjusted EBITDA, and adjusted EPS, leading to a raised full-year 2026 outlook. The company successfully repriced its Term Loan B, reducing annual interest expense by $12 million, and is targeting net leverage below 3x by 2028. These financial strengths support strategic investments and continued growth initiatives.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.