Revenue recognition for AUCATZYL, potential impact of tariffs on AUCATZYL, CAR-T persistence and autoimmune disease, manufacturing success rate and turnaround time, patient access programs and COGS are the key contradictions discussed in
Therapeutics' latest 2025Q1 earnings call.
AUCATZYL Launch and Revenue:
-
reported
$9 million in recognized
revenue for the first quarter of 2025.
- The revenue growth was driven by the successful launch of AUCATZYL in the U.S., with 39 authorized centers and 90% of total U.S. medical lives covered.
Geographic Expansion Strategy:
- The company received conditional marketing authorization for AUCATZYL from the MHRA in the UK and is preparing for launch in Germany.
- This expansion is part of a strategic plan to increase access to additional markets beyond the initial U.S. launch.
Financial Results and Operational Costs:
- The cost of sales totaled
$18 million, including the cost of all commercial AUCATZYL products delivered.
- This increase in costs was largely due to the sales value of products delivered but not yet administered and ongoing manufacturing expenses following AUCATZYL approval.
Clinical Trial and Product Pipeline Expansion:
- Autolus aims to treat 30 patients in a Phase 2 lupus nephritis trial and three patients at a 100 million cell dose in the CARLYSLE study.
- These clinical trial expansions are part of the company's plan to explore the utility of obe-cel in
consolidation settings and autoimmune diseases like lupus nephritis and multiple sclerosis.
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