AUTL

Commercial Launch of OCASL (Obicel/Capsule) in the U.S. and UK

• U.S. commercial launch is performing far ahead of original full-year 2026 expectations: the company already exceeded its full-year target of 80 authorized U.S. treatment centers by mid-year 2026, with additional centers continuing to be added through the second half. The company now projects ending 2026 with 90+ activated U.S. centers, prioritizing expansion in underserved regions to improve patient access across the U.S.
• UK commercial launch, started in early 2026, has shown strong initial adoption, with 20 authorized centers expected by the end of 2026 and a good footprint across England (market access for Scotland is still in process).
• Real-world clinical data from the ROCA consortium presented at the Tandem meeting has validated positive physician experience with the product, creating strong momentum for broader adoption. Physician interest has grown enough to support investigator-sponsored trials of OCASL in first-line ALL treatment, which are already underway.

Manufacturing and Gross Margin Progress

• The company has completed the first phase of establishing robust, consistent high-quality commercial product supply, and has now shifted focus to process optimization, efficiency gains, and volume scaling.
• Consolidation of both commercial and clinical manufacturing at the company's Nucleus facility in the UK increased total batch volume, spreading fixed manufacturing costs across more output and driving a sharp improvement in gross margins. The first clinical production at the Nucleus facility was completed in Q2 2026, further improving per-batch cost economics.
• Gross margin improved from negative in Q4 2025 to 6% in Q1 2026, reaching a healthy 55% in Q2 2026, with continued improvement expected towards a long-term target of 65-70% gross margin for the mature OCASL business.
• Management continues to optimize all steps of the manufacturing and supply chain, from raw material intake to final product release, to deliver additional efficiency gains. Further automation of the manufacturing process is planned over the next 12-15 months.
• Current manufacturing capacity is sufficient to meet expected demand for both adult and pediatric ALL for the foreseeable future. The company can mobilize additional clean room capacity if needed, but will delay this expansion to avoid unnecessary idle capacity and increased operating costs.

Pipeline and Clinical Development

• Multiple upcoming clinical data catalysts are scheduled through the end of 2026 and 2027, building on the commercial foundation of OCASL in adult ALL and expanding into new oncology and autoimmune indications:
  • End of 2026: Long-term follow-up data for the Carlyle study in systemic lupus erythematosus will be presented at the ACR conference; additional analysis from the Felix study will be released; initial data from the Auto8 phase 1 study (BCMA CD19 targeting for light chain amyloidosis) will be available.
  • Q1 2027: First safety, PKPD, biomarker, and early clinical data from the Bobcat phase 1 study in progressive multiple sclerosis will be presented at the ACTRMS meeting, with data from 12 patients expected. Additional data with longer follow-up from 18 patients is expected in H2 2027 to inform next steps for the program.
  • End of 2027: Enrollment completion and first data from the Catalyst pivotal study in pediatric ALL is expected, with regulatory filing targeted for late 2027/early 2028. Phase 2 data from the Lumina study in lupus nephritis is expected in 2028.

Financing Update

• The company closed a 5-year senior credit facility with Perceptive Advisors for up to $250 million in aggregate principal. $75 million was drawn at closing in July 2026, with an additional $25 million available for 6 months post-closing, and a further $150 million available in tranches upon achievement of pre-specified revenue milestones. This financing provides sufficient cash runway into Q2 2028 to support all planned pipeline and commercial milestones.

• Full-year 2026 net product revenue guidance for OCASL was upwardly revised from the original range of $120-$135 million to a new range of $140-$150 million.
• Gross margins for OCASL are expected to continue improving through the remainder of 2026 and beyond, with a long-term target of 65-70% for the mature adult ALL business, which management expects to reach within approximately 12 to 18 months.
• R&D spending is expected to remain roughly stable, in the mid-to-high $20 million per quarter range, with limited quarter-to-quarter variability tied to clinical production timing. No significant sustained ramp-up or reduction in R&D spending is expected in the near term.
• SG&A spending after adjusting for one-time 2026 restructuring charges (which are mostly completed) is expected to remain in the mid-to-high $30 million per quarter range, with only incremental increases from typical inflation.
• Autolus expects to reach 90+ authorized U.S. treatment centers for OCASL by the end of 2026, and approximately 20 authorized centers in the UK by the end of 2026.

Autolus has only one commercial product segment, OCASL (Obicel/Capsule) for adult relapsed refractory B-cell acute lymphoblastic leukemia (ALL). In Q2 2026, OCASL generated total net product revenue of $45.7 million, a 74% increase from $26.2 million in Q1 2026 and a 118.7% increase from $20.9 million in Q2 2025. For the first half of 2026, cumulative net OCASL revenue reached $71.9 million. Revenue is overwhelmingly generated in the U.S. market, with the UK (launched in early 2026) contributing only a minor share. Cost of sales for Q2 2026 was $20.5 million, down from $24.4 million in Q2 2025. Gross margin for OCASL improved to 55% in Q2 2026, up from 6% in Q1 2026 and negative gross margins in all prior 2025 quarters. Research and development (R&D) expense was $27.9 million in Q2 2026, roughly flat from $27.4 million in Q2 2025. Selling, general, and administrative (SG&A) expense increased to $41.2 million in Q2 2026 from $30.3 million in Q2 2025, driven by commercialization costs and one-time termination expenses from a April 2026 restructuring. Operating loss for Q2 2026 was $43.8 million, an improvement from an operating loss of $61.2 million in Q2 2025. Net loss for Q2 2026 was $39.1 million, an improvement from a net loss of $47.9 million in Q2 2025. As of June 30 2026, Autolus held $201.6 million in cash, cash equivalents and marketable securities.

All forward-looking statements, including clinical trial results, regulatory timelines, revenue projections, and margin improvement targets, are subject to inherent risks and uncertainties that could cause actual results to differ materially from current expectations. These risks are detailed in the company's press release and SEC filings, available on the Autolus website. Key risks highlighted by the company's activities include: potential quarter-to-quarter revenue fluctuations due to seasonality, slower-than-expected physician adoption at newly activated centers, delays in clinical trial enrollment or data readout, and unfavorable clinical trial results that could impact program progression. The company also faces the risk of unexpected manufacturing cost increases if capacity is expanded too early before demand materializes.

Q: The high end of the updated full-year revenue guidance implies a slight sequential decline from Q2's $45.7 million revenue. Is this due to conservatism, seasonality, or other one-time factors?

A: The Q2 revenue jump was in part driven by increased patient registrations following the positive real-world data release at the Tandem meeting, which boosted Q2 sales. Management notes that some seasonal quarter-to-quarter fluctuation is expected, and the updated guidance includes a reasonable element of prudence, while still reflecting a strong underlying foundation for the full year.

Q: Given gross margins already reached 55% in Q2, how should the margin trajectory look for the rest of the year, and when is the 65-70% target expected to be hit?

A: The Q2 jump reflected volume gains from consolidating commercial and clinical manufacturing at the Nucleus facility, plus broader operational efficiency improvements across the manufacturing process. These efficiency efforts will continue. Management reaffirms the 65-70% target for the mature ALL business, which it expects to reach within the next 12 to 18 months.

Q: Is OCASL growth coming from taking market share from existing CAR-T products or growing the overall market? Can you maintain the current strong sales pace?

A: The primary growth driver is expanding the overall CAR-T market rather than just taking share from competitors. A large share of OCASL patients have been patients that were previously not considered suitable candidates for CAR-T therapy, which is visible in the ROCA real-world data. Management confirms continued strong demand and is confident in the full-year guidance, and is optimistic about further momentum into 2027, while expecting some normal quarter-to-quarter fluctuation.

Q: What is the current UK launch contribution to Q2 revenue, and what is the expected trajectory for the rest of the year?

A: The UK has approximately one-sixth the population of the U.S., so its long-term revenue contribution is expected to reflect that ratio. At this early stage of launch, UK contribution is currently less than 10% of U.S. sales. Launch momentum is positive, with around 20 activated centers expected by year-end (covering most of England, with market access ongoing in Scotland), and the company expects this momentum to continue through the second half of 2026.

Q: Of the 80+ activated U.S. centers, how many have already treated patients, and is the time between activation and first treatment accelerating? What is the status of automation in manufacturing?

A: The vast majority of activated centers have already treated patients. Early centers had prior clinical trial experience with OCASL, so the transition to treatment was very fast. Newly added centers are mostly new to the product, so the pace of transition to first treatment is steady rather than accelerating. The manufacturing process is already substantially automated; further high-level automation changes are planned over the next 12-15 months, with efficiency gains already being realized across the entire supply chain.