ALVO

Regulatory and Facility Milestones

• Completed comprehensive facility and quality system improvements at the Reykjavik manufacturing site, enabling resubmission of four US BLAs for Symphony, Symphony Aria, ILEA, and Prolia/Xgeva biosimilars in June 2026.
• FDA closed the May 2026 GMP surveillance inspection of the Reykjavik facility with a Voluntary Action Indicated (VAI) classification; the site remains FDA-approved, and all prior inspection observations have been addressed.
• FDA confirmed 6-month standard review goal dates for the BLA resubmissions, with approval decisions expected in Q4 2026.

Commercial Update

• Five biosimilars now contribute to product revenue, up from two at the start of 2026, creating a more diversified growth platform.
• AVT02 (Humira biosimilar) holds the number two position in the US adalimumab biosimilar market, where total biosimilar penetration has grown to over 60%; demand remains strong despite first half supply constraints.
• ABT04 (Stellara biosimilar) has reached ~60% biosimilar penetration in the US Ustekinumab market, faster than industry penetration for Humira; the product remains well-positioned in both the US and Europe.
• ABT05 and ABT06 are already launched in over 10 major European markets; ABT05 launched in Japan in July 2026 as the only approved golimumab biosimilar there, while ABT06 launched in Japan earlier in 2026 with strong early uptake.
• The company is evaluating direct commercialization of selected pipeline products in the US, while retaining its primary B2B partner model for global market entry.

Pipeline Development

• Alvotech maintains one of the largest internally developed biosimilar pipelines in the industry, with over 30 candidates in development, prioritizing large market opportunities with high scientific barriers.
• European MAA for both intravenous (ABT16) and subcutaneous (ABT80) Entivio biosimilars has been validated and is under review; the US BLA for ABT16 is accepted, with a US BLA for ABT80 expected to be submitted shortly, and approval decisions targeted for 2027.
• ABT29 (ILEA high-dose biosimilar) is on track for European regulatory submission in 2026; the global first-in-class clinical trial for the US is progressing, with a US submission targeted for 2028, positioning the product as one of the first ILEA-HD biosimilars to market.

Financing

• Completed an oversubscribed equity financing in June 2026, generating $165 million in gross proceeds, and secured an additional $75 million term loan facility drawn in Q3 2026, for total new capital of $240 million.
• The financing attracted 20 new specialized healthcare investors, expanding and diversifying the company's shareholder base while increasing financial flexibility to support pipeline investment and launch preparations.

• Management reaffirmed full-year 2026 guidance of $650 to $700 million in total revenue, representing double-digit year-over-year growth from 2025, and $180 to $220 million in adjusted EBITDA.
• Q3 2026 is expected to see a gradual rebound in product revenue, with Q4 2026 projected to be the strongest quarter of the year as manufacturing output normalizes and supply builds for partner shipments; late 2026 approvals are not expected to contribute meaningfully to 2026 revenue.
• Full-year 2026 total R&D spend is projected to be approximately $200 million, with 50% of spend capitalized, and R&D expense expected to be split roughly evenly between H2 2026's two quarters.
• The company expects healthy balance sheet deleveraging in 2027, and a stronger margin profile entering 2027 as facility improvements are completed and manufacturing throughput normalizes.

Alvotech has five product biosimilar segments contributing to revenue: AVT02 (Humira biosimilar), AVT04 (Stellara biosimilar), ABT05 (Golimumab biosimilar), ABT06 (ILIA low-dose biosimilar), and Prolea/Xgeva biosimilar. No separate absolute revenue or contribution percentage is provided for individual segments. Aggregate total product revenue for the first half of 2026 was $106 million, representing 50% of total first half revenue of $212 million. The remaining 50% of first half revenue ($106 million) came from licensing and milestone revenue. For Q2 2026 alone, total revenue was $106 million, which was flat sequentially relative to Q1 2026 and down 39% year-over-year. Gross margin for Q2 2026 was 51%, and product margin was 6%, down 17 basis points year-over-year, impacted by product mix and facility improvement activities. Adjusted EBITDA for Q2 2026 was $23 million, down 32% year-over-year. For the first half of 2026, gross margin was 54% (broadly consistent with 55% in H1 2025), product margin was 8%, and adjusted EBITDA was $47 million (22% margin), compared to $54 million adjusted EBITDA (18% margin) in H1 2025.

• Reported revenue variability can occur between periods due to the B2B business model, dependence on partner order timing, inventory movements, and product supply availability.
• US launch timing for ABT05 and ABT06 remains contingent on successful regulatory approval and resolution of ongoing patent litigation, with outcomes expected in Q4 2026 but no guarantee of timely resolution.
• Biosimilar development carries inherent individual program risk related to technical, regulatory, competitive, and intellectual property uncertainties, managed via a broad portfolio approach.
• A confidential commercial and contractual provision was recorded in Q2 2026, with no further details provided due to commercial sensitivity.

Q: What is the impact of Biofera's issues on your ABT05 golimumab biosimilar in Europe and beyond, and which US assets are still unpartnered?

A: Alvotech and its European partner are well-positioned with sufficient supply to gain market share, already holding ~15% share and growing in Europe. The company is optimistic the disruption will drive long-term European growth, and it is prepared as a first-wave entrant for US approval in Q4 2026. Several pipeline assets remain unpartnered, with active licensing discussions ongoing, and updates expected for the market through Q3 and Q4 2026.

Q: Have there been any outstanding FDA requests on the recent BLA resubmissions, and what is the confidence in a Q4 2026 launch for the Symphony biosimilar?

A: The FDA has acknowledged all four BLA resubmissions as complete responses to prior action letters and confirmed 6-month standard review timelines aligned with the company's expectations. Approval is still expected in Q4 2026, with a decision in the ongoing patent litigation also expected that quarter; management feels strongly about its IP position and is prepared for launch following resolution.

Q: What is the expected US launch window for ABT16 (Entivio biosimilar), and is 2026 full-year R&D spend still on track to hit ~$250 million?

A: An approval decision for ABT16 is expected in early 2027, and management is comfortable with its IP position, expecting to pursue a near-term launch given its early filing positioning relative to competitors. Total full-year 2026 R&D spend is now projected at ~$200 million with 50% capitalized, with R&D expense split evenly between Q3 and Q4 2026.

Q: How much licensing/milestone revenue is included in H2 guidance, and what are the submission timelines for AVT80 and ABT29?

A: Guidance includes a healthy mix of product revenue and milestone revenue, with new licensing milestones expected in H2 2026, weighted heavily toward Q4. ABT29 (ILEA-HD) will be submitted in Europe in 2026, with US submission expected in 2028. US submission of AVT80 (subcutaneous Entivio) is expected to be announced imminently.