Autolus Therapeutics' Q3 2025: Contradictions Emerge on Revenue Recognition, Gross Margins, CMS Coding, and CAR-T Growth

Date of Call: November 12, 2025

Financials Results

• Revenue: $21.1M in Q3 2025, compared with $20.9M in Q2 2025; $51.0M for the first 9 months ended Sept 30, 2025

Guidance:

• ASH: expect pediatric Phase I and CARLYSLE SLE data plus FELIX analyses to be presented.
• Start Phase II portion of pediatric CATULUS and initiate pivotal LUMINA trial in lupus nephritis with first patient expected before year-end.
• First patient expected in ALARIC (light chain amyloidosis, UCL collaboration) before year-end.
• BOBCAT (progressive MS) Phase I started and first patient dosed in October.
• Strategic focus: drive adult ALL market share, improve margins via manufacturing/operational efficiencies, and expand into new indications.

Business Commentary:

* Commercial Launch and Market Access: - Autolus Therapeutics achieved $21.1 million in net sales in the third quarter, with $7.6 million in deferred revenue, indicating significant product availability for upcoming quarters. - The launch was successful due to achieving market leadership, broad market access, and reliable product delivery, with a well-established infrastructure.

• Manufacturing and Operational Efficiency:
• The manufacturing success rate was above 90%, ensuring reliable product supply and patient access for more than 90% of U.S. covered lives.

• Autolus is focusing on optimizing operations, leveraging investments in infrastructure, and data collection to streamline processes and drive efficiencies.

• CAR-T Market Penetration:

• In the centers active in treating relapsed/refractory B-ALL patients, the CAR-T market penetration increased to approximately 20%.

• This growth is attributed to physicians' positive experience with obe-cel, leading to increased adoption and potential for further relationship building and uptake.

• Clinical Trials and Product Pipeline:

• Autolus is initiating a potential pivotal study in pediatric ALL and advancing trials in lupus nephritis and multiple sclerosis.
• The expansion of the product pipeline is supported by positive data from ongoing trials, including the significant improvement seen in lupus nephritis patients.

Sentiment Analysis:

Overall Tone: Positive

• Management: "We had a very good quarter, and I think we're off to an excellent launch" and reported "$21.1 million in net sales" with "$7.6 million" deferred revenue; highlighted "manufacturing success rate well above 90%" and "patient access for more than 90% of U.S. covered lives." CFO: cash position "$367.4 million... well capitalized" to fund launch and pivotal trials.

Q&A:

• Question from Asthika Goonewardene (Truist Securities): Can you talk about current patient flow and what proportion shifted from previously planned Tecartus treatments to AUCATZYL?
  Response: Many treated patients were not previously considered for CAR‑T; launch is expanding penetration and use is consistent across centers, supporting further uptake as centers gain experience.

• Question from Gil Blum (Needham & Company): For pediatric patients, is differentiation similar to adults (safety) or how are you positioning obe‑cel in pediatrics?
  Response: Focus is on high‑risk pediatric patients (many ineligible for CAR‑T); obe‑cel shows favorable safety/efficacy in children and reliable product access is key to adoption.

• Question from Salim Syed (Mizuho Group): What drove Q3's roughly flat performance vs Q2 given ATC increases and deferred revenue — any seasonality or pent‑up demand? And how are you handling D&A in COGS?
  Response: A CMS reimbursement/coding change and trade‑policy adjustments created a Q2–Q3 enrollment lag; deferred revenue indicates manufactured product awaiting Q4 infusion; depreciation and amortization are included in COGS under standard accounting and not separately broken out.

• Question from Yanan Zhu (Wells Fargo): Where will CAR‑T share growth come from in relapsed/refractory B‑ALL, any frontline consolidation seen, and updated view on autoimmune competitive landscape vs bispecifics?
  Response: Growth will come from increasing CAR‑T penetration within existing centers (current ~20%); frontline use is unlikely near‑term without data/label changes; autoimmune data are encouraging but heterogeneous — obe‑cel positions well for severe patients based on safety and efficacy.

• Question from Sam on behalf of James (Deutsche Bank): Can you provide more color on the data you expect to present at ASH?
  Response: ASH will include pediatric Phase I poster (~20 patients), expanded CARLYSLE PD/immune‑reset and safety data, and FELIX analyses linking product phenotype and 3‑month persistence to longer‑term outcomes.

• Question from Yuxi Dong (Jefferies): Have you had regulatory interactions with the FDA regarding the pediatric pivotal trial and what would qualify it as pivotal?
  Response: We reviewed Phase I data and trial design with FDA and COG; FDA agreed on the high‑risk pediatric population, study size and data needs, providing clarity to proceed with a pivotal Phase II cohort.

• Question from Madeleine Stone (William Blair): Timelines for completing the pediatric pivotal cohort and what is the total market opportunity across adult and pediatric ALL?
  Response: Addressable pediatric population ~1,000 patients (≈500 U.S.) with an initial reachable few hundred; Phase II is starting now with follow‑up in 2027 and potential data late‑2027 to early‑2028.

• Question from Shyam Kotadia (Goldman Sachs): Given the CMS coding impact, were Q3 results above/below expectations and how should we think about AUCATZYL sales for 4Q and trajectory into 2026?
  Response: Q3 dynamics were consistent with prior guidance that a CMS‑driven lag would affect Q2–Q3; late‑Q3 activity recovered and deferred revenue supports Q4 infusions, but no Q4 guidance provided due to year‑end seasonality; company expects to enter a growth phase in 2026 without specific targets disclosed.

• Question from Simon Baker (Rothschild & Co Redburn): Deferred revenue was $7.6M — how typical is that and what are the underlying COGS trends/timeline for gross margin improvement?
  Response: Deferred revenue reflects products shipped to centers but not yet infused due to scheduling/clinical delays; COGS is noisy early in launch but margins should improve as volumes rise and manufacturing/operational efficiencies and automation reduce per‑batch costs over time.

Contradiction Point 1

Revenue Recognition and Enrollment Patterns

It involves the impact of CMS coding changes on revenue recognition and patient enrollment patterns, which directly affect company revenue and financial projections.

What is the outlook for AUCATZYL through 2026? - Shyam Kotadia (Goldman Sachs Group, Inc., Research Division)

2025Q3: Q3 dynamics were impacted by CMS coding changes, and Q4 sales will be influenced by seasonality and holidays. - Christian Itin(CEO)

If a patient receives only the first infusion, will the company recognize remaining revenue? Can the company achieve positive gross profit by year-end 2023 or 2024? - Matthew Christopher Phipps (William Blair)

2025Q2: The CMS decision affected administrative processes at medical centers, leading to delays in patient enrollment. - Robert F. Dolski(CFO)

Contradiction Point 2

Gross Margin Improvements

It involves statements regarding gross margin improvements, which are critical financial indicators for investors.

How typical is the deferred revenue balance, and is there any improvement in gross margin? - Simon Baker (Rothschild & Co Redburn, Research Division)

2025Q3: COGS are noisy due to initial manufacturing setup not fully utilized. We expect cost Improvements as volumes increase and efficiencies improve. - Christian Itin(CEO)

What happens if a patient only receives the first infusion? Can the remaining revenue be recognized? Will the company achieve a positive gross profit by year-end 2023 or 2024? - Matthew Christopher Phipps (William Blair)

2025Q2: Gross margin is improving due to volume, with an expectation of continued movement in the right direction in the second half of the year. - Robert F. Dolski(CFO)

Contradiction Point 3

Impact of CMS Coding Changes on Revenue Recognition

It affects the revenue recognition process for a key product, AUCATZYL, which could influence financial reporting and investor expectations.

What caused the flat performance of AUCATZYL between Q2 and Q3? Are you seeing seasonality in the business now? - Unknown Analyst (Mizuho Group)

2025Q3: The impact from CMS changed reimbursement policies affected the second and third quarters. - Christian Itin(CEO)

Regarding AUCATZYL's April 1 coding update, was the $9 million revenue in Q1 2025 triggered by initial dosing or full split dose completion? - James Shin (Deutsche Bank)

2025Q1: CMS's coding update for AUCATZYL impacts revenue recognition. The timing between the first and second administration is typically 9 days. - Christian Itin(CEO)

Contradiction Point 4

CAR-T Market Share Growth Opportunities

It pertains to the company's growth strategy and market positioning, which are crucial for investors' understanding of the company's competitive landscape.

What are the drivers for CAR-T market share growth? How is the current competitive landscape in autoimmune diseases based on recent industry data? - Yanan Zhu (Wells Fargo Securities, LLC, Research Division)

2025Q3: Growth opportunities are substantial in existing centers with 20% market share. - Christian Itin(CEO)

How many Tecartus patients are eligible for AUCATZYL? What caused the 20% QoQ decline in Tecartus sales in 1Q? - Karina Rabayeva (Truist)

2025Q1: We believe there is a good chance that a substantial portion of the Tecartus market in mantle cell lymphoma could migrate to AUCATZYL. - Christian Itin(CEO)

Contradiction Point 5

Deferred Revenue and Product Costs

It involves clarification on the nature of deferred revenue and its relationship with product costs, which are critical financial metrics.

How typical is the deferred revenue balance, and is there any improvement in gross margin? - Simon Baker (Rothschild & Co Redburn, Research Division)

2025Q3: Deferred revenue reflects products manufactured but not yet infused. - Christian Itin(CEO)

Could you clarify how canceled orders and patient access programs affected COGS? Does obe-cel's greater persistence in autoimmune diseases make it unique compared to other CAR-T therapies? - Matthew Phipps (William Blair)

2025Q1: Deferred revenue represents product sales value, not cost. - Rob Dolski(CFO)