What changed in this filing

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Item 7. Management’s Discussion and Analysis

2026-03-27 compared with 2025-03-20 · 206 added, 137 removed, 313 unchanged (52% of the section changed)

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dollars at that or any other exchange rate as of that or any other date.

Autolus, AUCATZYL and our other trademarks or service marks appearing in this report are our property.

Solely for convenience, the trademarks and trade names in this report are referred to without the ® and TM symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto.

Products or service names of other companies mentioned in this report may be trademarks, trade names or service marks of their respective owners.

We are an early commercial-stage biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer and autoimmune diseases.

Using our broad suite of proprietary and modular T cell programming technologies, we are engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize target cells, break down their defense mechanisms and attack and kill these cells.

We believe our programmed T cell therapies have the potential to be best-in-class and offer patients substantial benefits over the existing standard of care, including the potential for cure in some patients.

We believe our programmed T cell therapies have the potential to be best-in-class and to offer patients substantial benefits over the existing standard of care, including the potential for cure in some patients.

Since our inception, we have incurred significant operating losses.

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As of December 31, 2025, we had an accumulated deficit of $1,386.8 million.

Based on our current commercial and development plans, we believe our existing cash and cash equivalents of $227.4 million and marketable securities of $360.6 million at December 31, 2024, will be sufficient to fund our current and planned operating expenses and capital expenditure requirements through at least the next twelve months from the date of this Annual Report.

The forecast of cash resources is forward-looking information that involves risks and uncertainties, and the actual amount of our revenues and expenses, which we have based on assumptions that may prove to be wrong and could prove to be significantly higher than we currently anticipate, could vary materially and adversely as a result of a number of factors.

Based on our current commercial and development plans, we believe our existing cash and cash equivalents of $104.1 million and available for sale debt securities ( “ marketable securities ” ) of $196.6 million at December 31, 2025, will be sufficient to fund our current and planned operating expenses and capital expenditure requirements through at least the next twelve months from the date of this Annual Report.

This forecast of cash resources is forward-looking information that involves risks and uncertainties, and the actual amount of our revenues and expenses, which we have based on assumptions that may prove to be wrong and could prove to be significantly higher than we currently anticipate, could vary materially and adversely as a result of a number of factors.

Management does not know whether additional financing will be on terms favorable or acceptable to us when needed, if at all.

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Recent Developments

• AUCATZYL U.S.

• AUCATZYL was approved by the FDA for the treatment of adult patients with relapsed and refractory B-cell acute lymphoblastic leukemia on November 8, 2024.

• In December 2024, the National Comprehensive Cancer Network® (NCCN) added AUCATZYL to its Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for the treatment of adult patients with r/r B-ALL.

commercial launch progresses on track, with 33 centers authorized as of March 19, 2025 (versus the Company’s initial target of 30 by the end of Q1 2025), covering approximately 60% of the target U.S.

patient population

• Autolus continues to expect to complete authorization of 60 treatment centers by the end of 2025, covering approximately 90% of the target patient population

AUCATZYL launch:

• We reported net product revenue of $74.3 million for the year ended December 31, 2025, driven by sales in the United States.

• Following a successful National Institute for Health and Care Excellence (NICE) evaluation in the United Kingdom, AUCATZYL launched in the United Kingdom in December 2025 and is now available under routine commissioning.

• Data from the Real-World Outcomes Collaborative for CAR T in Adult ALL (“ROCCA”) Consortium database evaluating patient characteristics, toxicity and response after real-world administration of AUCATZYL was presented at the American Society of Hematology (“ASH”) Annual Meeting in December 2025 and the TANDEM meeting in February 2026.

Real-world data show improvements in both safety and efficacy compared to the FELIX clinical trial that was the basis for regulatory approvals.

The ROCCA Consortium registry covers approximately 60% of U.S.

commercial patients at a data cutoff of January 5, 2026.

Obe-cel updates:

Obecabtagene autoleucel (obe-cel) in relapsed / refractory (r/r) adult ALL – FELIX Study

• Obe-cel is under regulatory review in both the EU and the U.K., and the Company expects to receive notification of approval status from the MHRA and EMA in second half of 2025

• Post period, Autolus submitted obe-cel for appraisal by the U.K.

National Institute for Health and Care Excellence ( “ NICE ” ), and a decision is expected at the time of a potential MHRA approval

• Autolus has presented updated data on obe-cel in adult ALL at the Society of Hematologic Oncology ( “ SOHO ” ) meeting in August 2024, the Lymphoma, Leukemia & Myeloma Congress in October 2024, the American Society of Hematology ( “ ASH ” ) Meeting in December 2024, and post-period at TANDEM 2025.

The data presented at these conferences builds on previously published obe-cel data, highlighting its tolerability and long-term responses.

In addition, a health economic cost model has been presented, directly comparing the cost of serious adverse events across various comparable CAR-T cell therapies.

Obe-cel in B-cell mediated autoimmune diseases

• The Phase 1 dose confirmation study ( “ CARLYSLE ” ) in refractory SLE patients is ongoing, with all six patients dosed.

Autolus will present the initial data from this trial and development plans at its R&D event being held on April 23, 2025, and its are targeting the second half of 2025 for the presentation of full data with longer term follow-up.

Obe-cel data in r/r B-ALL

• Preliminary data from the CATULUS Phase 1 trial of obe-cel in pediatric relapsed or refractory r/r B-ALL patients were presented at the ASH Annual Meeting in December 2025.

Obe-cel demonstrated high remission rates in pediatric patients with high-risk r/r B-ALL with overall response rate (ORR) of 95.5%.

Low rates of high-grade cytokine release syndrome (“CRS”) and immune effector cell-associated neurotoxicity syndrome (“ICANS”) were observed, consistent with obe-cel’s adult safety profile.

The Phase 2 portion of the trial is underway and Autolus expects to have the trial fully enrolled in the first half of 2027.

• In October 2025, the FDA granted regenerative medicine advanced therapy (“RMAT”) designation to obe-cel for the treatment of pediatric patients with r/r B-ALL.

The RMAT designation is a program created under the 21st Century Cures Act to accelerate development and regulatory review of regenerative medicine therapies, including cell therapies, intended to treat serious or life-threatening diseases.

Obe-cel in lupus nephritis ( “ LN ” )

• Data from the ongoing Phase 1 CARLYSLE trial in patients with severe refractory systemic lupus erythematosus were reported at the American College of Rheumatology Convergence 2025 and the ASH Annual Meeting.

All patients show deep B-cell depletion after infusion, suggesting an immune reset.

No ICANS or high-grade CRS were observed in the nine patients evaluable for safety.

• Data support progressing obe-cel as a treatment for LN and 50 million cells was selected as the recommended Phase 2 dose.

• We have previously aligned with the FDA on a Phase 2 trial design in LN and potential registrational path to approval.

The LUMINA trial is now enrolling.

Obe-cel in progressive multiple sclerosis ( “ MS ”)

• We have advanced obe-cel into initial clinical development to explore treatment in progressive MS.

The first patient in the Phase 1 BOBCAT trial was dosed in October 2025.

The Phase 1 trial, expected to include up to 18 adult patients, will determine the safety, tolerability, and preliminary efficacy of obe-cel in participants with refractory progressive forms of MS.

Initial data from the Phase 1 trial are expected to be reported at the end of 2026.

AUTO8 in AL-Amyloidosis

• The first patient was dosed in the Phase 1 ALARIC trial evaluating AUTO8 in light-chain amyloidosis and initial data is expected to be reported at the end of 2026.

Early stage pipeline programs and collaborations:

• Clinical programs AUTO8 and AUTO6NG are progressing, and the Company is planning updates for programs at its R&D event which will be held on April 23, 2025.

• BioNTech’s product option for AUTO1/22 was not exercised as a result of BioNTech’s pipeline prioritization, and has expired as of February 8, 2025.

• Autolus’ translational programs with UCL continue to fuel its early-stage pipeline, providing a cost-efficient path to development to support long-term growth

• In November 2025, Moderna announced that the first patient has been dosed in a Phase 1/2 study of mRNA-2808, an investigational mRNA-based T-cell engager for participants with relapsed or refractory multiple myeloma.

mRNA-2808 utilizes Autolus’ proprietary binder that was licensed to Moderna in 2022.

Strategic Financing Agreements

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We will pay BioNTech a low single-digit percentage of annual net sales of obe-cel products, including revenues from sales of AUCATZYL, which may be increased up to a mid-single digit percentage in exchange for milestone payments of up to $100 million in the aggregate on achievement of certain regulatory events for specific new indications upon BioNTech's election.

We expect to make initial payments of the revenue interest to BioNTech in 2025.

During the year ended December 31, 2025, we made quarterly payments of the revenue interest to BioNTech in an aggregate amount of $1.5 million

Manufacturing and Commercial Agreement

Under the terms of the License Agreement, we have granted BioNTech the option to negotiate a joint manufacturing and commercial services agreement pursuant to which we and they may access and leverage each other’s manufacturing and commercial capabilities, in addition to our commercial site network and infrastructure, with respect to certain of each parties’ CAR T products, including BioNTech’s product candidate BNT211 (the “Manufacturing and Commercial Agreement”).

The term of this option expired in August 2025, 18 months following execution of the License Agreement.

Securities Purchase Agreement, Registration Rights Agreement and Letter Agreement

Concurrently with the execution of the License Agreement, we and BioNTech entered into a Securities Purchase Agreement (the “Purchase Agreement”) pursuant to which we issued and sold 33.3 million ADSs to BioNTech at $6.00 per ADS for aggregate gross proceeds of $200.0 million.

In the event that we and BioNTech enter into the Manufacturing and Commercial Agreement described above within 18 months of the initial closing under the Purchase Agreement, BioNTech will purchase additional ADSs, not to exceed 15.0 million ADSs, for an aggregate purchase price of up to $20.0 million.

The total number of ADSs that may be issued to BioNTech is subject to additional limitations and restrictions.

BioNTech also has the right to purchase equity securities sold by us in bona fide financing transactions in amounts that are based on BioNTech maintaining specified ownership thresholds following such financing transactions.

We agreed to register those shares as described in the Registration Rights Agreement.

Pursuant to the Letter Agreement, BioNTech also has the right to appoint a non-executive director of the Company and to purchase equity securities sold by us in bona fide financing transactions in amounts that are based on BioNTech maintaining specified ownership thresholds following such financing transactions.

Pursuant to the Blackstone Collaboration Agreement, Blackstone agreed to pay the Company up to $150.0 million to support the c ontinued development of obe-cel, as well as next generation product therapies of obe-cel in B-cell malignancies.

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The Company considers the achievement of the specified regulatory milestone as probable when actually achieved (i.e., when the contingency resolves).

During the year ended December 31, 2025, we made quarterly payments of the revenue interest to Blackstone in an aggregate amount of $2.8 million.

Financial Operations Overview

Product Revenue, Net

As of December 31, 2025, our product revenue comprised of sales of AUCATZYL in the U.S.

We use Cardinal Health 105, LLC (“Cardinal Health”) as an agent to deliver the Company's product, AUCATZYL, to Authorized Treatment Centers (“ATCs”).

The ATCs are responsible for the treatment of the patient including administration of the product which occurs in two separate doses.

Cardinal Health is obligated to pay us for the product upon the delivery and acceptance of the product at the ATC within standard payment terms.

The ATC is obligated to pay Cardinal Health for the product upon receipt and acceptance of the product and is entitled to a credit, in certain circumstances, including when the patient is not administered one or both doses.

On April 1, 2025, the Centers for Medicare and Medicaid Services (“CMS”) included AUCATZYL in their published Healthcare Common Procedure Coding System coding determinations and Hospital Outpatient Prospective Payment System payment rates, formalizing reimbursement for patients on government programs.

The CMS policy splits the therapeutic dose of AUCATZYL into two administrations for coding and billing purposes.

We account for product revenues pursuant to the provisions of ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”).

Under ASC 606, the Company recognize revenue when the customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services.

To determine revenue recognition for arrangements we determine are within the scope of ASC 606, we perform the following five steps:

(i) identify the contract(s) with a customer;

(ii) identify the performance obligations in the contract;

(iii) determine the transaction price, including variable consideration, if any;

(iv) allocate the transaction price to the performance obligations in the contract;

and (v) recognize revenue when (or as) the entity satisfies a performance obligation.

We only apply the five-step model to contracts when it is probable that we will collect the consideration to which it is entitled in exchange for the goods or services it transfers to the customer.

We have determined that the patient is the customer pursuant to ASC 606 in the arrangement.

We have identified a single performance obligation which is satisfied when the patient has received its final dose of the product.

The Company records an accounts receivable on the balance sheet when product sales are invoiced and the final dose of the product has been administered to the patient.

In the quarter ended December 31, 2025, we revised our revenue recognition policy to conclude the patient is the customer in the transaction and that revenue should not be recognized until the administration of the final dose to the patient.

We had previously recognized a portion of the transaction price as revenue upon the first dose and the remainder of the transaction price as revenue upon the second dose.

Further, we had recorded accounts receivable and deferred revenue upon delivery of the product to the ATC.

The impact of our revised revenue recognition policy was not considered material to any previously issued financial statements.

Product revenue, net of gross-to-net deductions, is recognized only to the extent that a significant reversal in the amount of cumulative revenue recognized is not probable of occurring when the uncertainty associated with gross-to-net deductions is subsequently resolved.

Product revenue is recognized net of estimated rebates and chargebacks, patient travel assistance and patient co-pay assistance deductions.

These deductions to product revenue are referred to as gross-to-net deductions and are estimated and recorded in the period in which the related product revenue occurs.

Gross-to-net deductions

Rebates and chargebacks

Rebates and chargebacks are based on contractual arrangements or statutory requirements and include amounts due to payors and healthcare providers under various programs.

These amounts may vary by payor and individual plans.

Providers qualified under certain programs can purchase our products through our third-party logistics partner at a discount.

Our third party logistics partner then charges the discount back to us.

Rebates and chargebacks are estimated primarily based on product sales, including pricing, historical and estimated payor mix, setting of care and discount rates, among other inputs, which require significant estimates and judgment.

We assess and updates our estimates each reporting period to reflect actual claims and other current information.

Our wholly-owned subsidiary in the United States also participates in programs with government entities, the most significant of which are the covered entities under the 340B Drug Pricing Program (the “340B Program”), the U.S.

Department of Defense (the “DoD”), and the US.

Department of Veterans Affairs (the “VA”), whereby pricing on products is extended below list price to participating entities.

These entities purchase products at the lower program price then charge the Company the difference between their acquisition cost and the lower program price.

The price differential is accrued for as part of the gross to net liabilities and will be reflected as a reduction to accounts receivable, net when actual chargeback is processed and applied.

Our wholly-owned subsidiary in the United States further participates in state government Medicaid programs and the DoD's Tricare program.

All discounts and rebates provided through these programs are included in the Company's Medicaid and Tricare rebate accrual.

The estimated amount of unpaid or unbilled rebates are to be recognized and presented as a liability.

Patient Travel, Lodging and Meal Assistance

Travel, lodging, and meal assistance represents financial assistance to qualified patients and their caregiver, reimbursing them for certain travel, lodging, and meal expenses required during their treatment.

We expense the actual expenses made during the period and accrue the estimated unreported or unrecorded expenses at period end.

Patient Co-Pay Assistance

Co-pay assistance represents financial assistance to qualified patients, assisting them with cost sharing obligations for our product based on benefit design structure required by insurance.

Our accrual for copay is based on an estimate of claims and the cost per claim that we expect to receive associated with qualified patients that exist at each reporting period.

License Revenue

We account for our revenue pursuant to the provisions of ASC Topic 606 .

We have one product approved for commercial sale but have not generated any revenue from commercial product sales through the period covered by this Annual Report.

Rather, our total revenue to date has been generated principally from license agreements.

During the year ended December 31, 2024, we entered into various license agreements which included non-refundable upfront license fees, options for future commercial licenses, payments based upon achievement of clinical development and regulatory objectives, payments based upon achievement of certain levels of product sales, and royalties on licensed product sales .

We account for our revenue pursuant to the provisions of ASC 606 .

As of December 31, 2025, we have entered into various license agreements which included non-refundable upfront license fees, options for future commercial licenses, payments based upon achievement of clinical development and regulatory objectives, payments based upon achievement of certain levels of product sales, and royalties on licensed product sales .

In determining the appropriate amount of revenue to be recognized in relation to each license agreement, we perform the following steps:

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Contingent Research Milestone Payments

ASC Topic 606 constrains the amount of variable consideration included in the transaction price in that either all, or a portion, of an amount of variable consideration should be included in the transaction price.

ASC 606 constrains the amount of variable consideration included in the transaction price in that either all, or a portion, of an amount of variable consideration should be included in the transaction price.

The variable consideration amount should be included only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved.

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Cost of Sales

Cost of sales represents production costs including raw materials, employee-related expenses, including salaries, related benefits, travel and share-based compensation expense for employees engaged in commercial manufacturing functions, external manufacturing costs including outsourced professional expenses services, allocated facilities costs, depreciation and other expenses, and other costs incurred in bringing inventories to their location and condition prior to sale.

Cost of sales represents production costs including raw materials, employee-related expenses, including salaries, related benefits, travel and share-based compensation expense for employees engaged in commercial manufacturing functions, external manufacturing costs including outsourced professional expenses services, allocated facilities costs, depreciation and other expenses, royalties payable to third-parties and other costs incurred in bringing inventories to their location and condition prior to sale.

Cost of sales also includes the cost of all commercial product which is recognized as cost of good sold upon final administration to the patient, any cancelled orders, and product related to the patient access program.

Cost of sales may also include costs related to excess or obsolete inventory adjustment charges and amortization expense of intangible assets

Cost of sales for a newly launched product does not include the full cost of manufacturing until the initial pre-launch raw materials inventory is depleted.

Thus, the cost of sales as a percentage of net sales of AUCATZYL for the year ended December 31, 2025 was affected by use of the initial pre-launch raw materials inventory, which was previously expensed as research and development expense, and is referred to as zero cost inventories.

We estimate cost of sales as a percentage of net product revenue and will continue to be positively impacted as we sell products which includes some raw material inventory that was previously expensed prior to the FDA approval.

Research and Development Expenses, Net

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We also expect to incur additional expenses related to milestone, royalty payments and maintenance fees payable to third parties with whom we have entered into license agreements to acquire the rights related to our product candidates.

After consultation, we have been advised by HMRC that any sale of our obe-cel CAR T therapy to U.K.

customers in the future will be considered an exempt supply from a U.K.

VAT perspective.

Consequently, we have assessed and restricted the amount of U.K.

VAT we have historically reclaimed and will continue to do so in the future.

The restriction will be based on the estimated U.K.

market turnover as a percentage of global turnover.

We currently expect revenue from U.K.

customers to only represent a small proportion of our overall activity.

If the proportion of revenue from U.K.

customers increases this would further restrict the amount of U.K.

input VAT recovered.

After consultation, we have been advised by HMRC that any sale of our obe-cel CAR T therapy to United Kingdom customers in the future will be considered an exempt supply from a United Kingdom VAT perspective.

Consequently, we have assessed and restricted the amount of United Kingdom VAT we have historically reclaimed and will continue to do so in the future.

The restriction will be based on the estimated United Kingdom market turnover as a percentage of global turnover.

We currently expect revenue from United Kingdom customers to only represent a small proportion of our overall activity.

If the proportion of revenue from United Kingdom customers increases this would further restrict the amount of United Kingdom input VAT recovered.

Included in research and development expenses is historical irrecoverable input VAT previously claimed on research and development expenses and subsequently reversed.

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Any changes in the outcome of any of these variables with respect to the development of our product candidates in clinical development could mean a significant change in the costs and timing associated with the development of these product candidates.

For example, if the European Medicines Agency (“EMA”), the FDA, or another regulatory authority were to delay our planned start of clinical trials or require us to conduct clinical trials or other testing beyond those that we currently expect or if we experience significant delays in enrollment in any of our planned clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development of that product candidate.

For example, if the European Medicines Agency (“EMA”), national competent authorities of EU Member States, as applicable, the FDA, the MHRA, or another regulatory authority were to delay our planned start of clinical trials or require us to conduct clinical trials or other testing beyond those that we currently expect or if we experience significant delays in enrollment in any of our planned clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development of that product candidate.

Commercialization of our product candidates will take several years and millions of dollars in development costs.

Research and Development Tax Credits

Research and development expenditure is presented net of reimbursements from reimbursable tax and expenditure credits from the U.K.

As a company that carries out extensive research and development activities, we benefit from the SME regime and, to the extent that our projects are grant funded, the RDEC regime .

The benefits from U.K.

research and development tax credits are recognized in the statements of operations and comprehensive loss as a reduction of research and development expenses and represents the sum of the research and development tax credits recoverable in the U.K.

The SME program has been particularly beneficial to us, as under such program the trading losses that arise from our qualifying R&D activities can be surrendered for a cash rebate of up to 33.35% of qualifying expenditure incurred prior to April 1, 2023 and decreasing to 18.6% after April 1, 2023.

Government also enacted further changes to the SME regime effective from April 1, 2023 (with some amendments effective for accounting periods commencing after April 1, 2024) which included the introduction of a new rate for R&D intensive companies of 27%.

Qualifying expenditures largely comprise employment costs for research staff, consumables, outsourced contract research organization costs and utilities costs incurred as part of research projects for which we do not receive income.

A large proportion of costs in relation to our pipeline research, clinical trials management and manufacturing development activities, all of which are being carried out by our subsidiary Autolus Limited, are eligible for inclusion within these tax credit cash rebate claims.

Under the RDEC program, tax credits for qualifying R&D expenditure incurred prior to April 1, 2023 are granted at a headline rate of 13% and can generate cash rebates of up to 10.5% of qualifying R&D expenditure.

The headline rate of RDEC increased to 20% on April 1, 2023 and can generate cash rebates of up to 15% on qualifying R&D expenditure incurred from this date.

Amendments to the current SME and RDEC programs contained in the Finance Act 2024 (unless limited exceptions apply) introduce restrictions on the tax relief that can be claimed for expenditure incurred on sub-contracted R&D activities or externally provided workers, where such sub-contracted activities are not carried out in the U.K.

or such workers are not subject to U.K.

payroll taxes, and (ii) merge the SME and RDEC programs into a single scheme which would generate net cash benefit of up to 15% of the qualifying expenditure for profit making companies and up to 16.2% for loss making companies.

These changes take effect from periods commencing after April 1, 2024.

In the accounting period ended December 31, 2024, we met the conditions of the SME regime, but we could also make claims under the RDEC regime to the extent that our projects are grant funded.

In addition, based on the relevant tax legislation, we may meet the conditions of the R&D intensive scheme.

From January 2025, we will not qualify as a small or medium-sized enterprise under the SME program, based on size criteria concerning employee headcount, turnover and gross assets.

However, we may make a claim under the merged RDEC regime for periods ending December 31, 2025.

It should be noted, however, that the types of qualifying expenditure in respect of which we may make claims under the RDEC regime are more restricted than under the SME regime (for example, it may be the case that certain subcontracted costs in respect of which claims may be made under the SME regime do not qualify for relief under the RDEC regime).

Research and development expenditure is presented net of reimbursements from reimbursable tax and expenditure credits from the United Kingdom government.

As a company that carries out extensive research and development activities, we benefit from the Research and Development tax incentives provided by United Kingdom tax legislation.

The specific provisions available to claim under vary year on year dependent on the criteria met.

The benefits from United Kingdom research and development tax credits are recognized in the statements of operations and comprehensive loss as a reduction of research and development expenses and represents the sum of the research and development tax credits recoverable in the United Kingdom.

The SME program has been particularly beneficial to us as under such program the trading losses that arise from our qualifying R&D activities can be surrendered for a cash rebate of up to 33.35% of qualifying expenditure incurred prior to April 1, 2023 and decreased to 18.6% after April 1, 2023.

The United Kingdom government enacted changes to the SME regime effective from April 1, 2023 which included the introduction of a new rate for R&D intensive companies of 27%.

Qualifying expenditures largely comprise of employment costs for research staff, consumables, outsourced contract research organization costs and utilities costs incurred as part of research projects for which we do not receive income.

A large proportion of costs relate to our pipeline research, clinical trials management and manufacturing development activities, all of which are being carried out by our subsidiary Autolus Limited, are eligible for inclusion within these tax credit cash rebate claims.

Under the RDEC program, the headline rate for qualifying R&D expenditure is 20% and can generate cash rebates of up to 15% on qualifying R&D expenditure.

Amendments to the current SME and RDEC programs contained in the Finance Act 2024 (unless limited exceptions apply) introduce (i) restrictions on the tax relief that can be claimed for expenditure incurred on sub-contracted R&D activities or externally provided workers, where such activities are not carried out in the United Kingdom or such workers are not subject to United Kingdom payroll taxes, and (ii) merge the SME and RDEC programs into a single scheme which would generate net cash benefit of up to 15% of the qualifying expenditure for profit making companies and up to 16.2% for loss making companies.

These changes apply to periods commencing after April 1, 2024.

In the accounting period ended December 31, 2025, we will not qualify for relief under the SME program, based on size criteria concerning employee headcount, turnover and gross assets.

However, we may make a claim under the merged RDEC regime, as detailed above.

Selling, General and Administrative Expenses

Selling, general and administrative expenses consist primarily of salaries, related benefits, travel and share-based compensation expense for personnel in executive, finance, legal and other administrative functions.

Included in general and administrative expenses is historical irrecoverable input VAT previously claimed on general and administrative expenses and subsequently reversed.

We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support the planned development of our product candidates.

Selling, general and administrative expenses also include allocated facility-related costs, patent filing and prosecution costs and professional fees for marketing, insurance, legal, consulting, accounting, termination benefits and related charges, audit services, gains and losses on disposal of property and equipment and impairment of operating lease right of use assets and related property and equipment.

Included in selling, general and administrative expenses is historical irrecoverable input VAT previously claimed on selling, general and administrative expenses and subsequently reversed.

We anticipate that our selling, general and administrative expenses will increase in the future as we increase our headcount to support the planned development of our product candidates.

We anticipate an increase in salaries and related benefits as a result of our preparation for commercial operations, especially as it relates to the sales and marketing of AUCATZYL and our other product candidates.

We have experienced, and expect to continue to experience, increased expense with being a public company, including increased accounting, audit, legal, regulatory and compliance costs associated with maintaining compliance with Nasdaq listing rules and SEC requirements, director and officer insurance premiums, as well as higher investor and public relations costs.

Additionally, should we fail to maintain our status as a foreign private issuer, we would expect to incur increased expenses to remain compliant with applicable SEC and Nasdaq requirements.

Loss on disposal of property and equipment

Loss on disposal of property and equipment primarily consists of losses arising from the disposal of all categories of property and equipment.

Impairment of operating lease right-of-use assets and related property and equipment

Impairment of operating lease right-of-use assets and related property and equipment consists primarily of impairment losses arising from the impairment of leased properties and leasehold improvements that are currently not be utilized by us.

We have experienced, and expect to continue to experience, increased expense with being a public company, including increased accounting, audit, legal, regulatory and compliance costs associated with maintaining compliance with Nasdaq listing rules and the SEC requirements, director and officer insurance premiums, as well as higher investor and public relations costs.

Additionally, should we fail to maintain our status as a foreign private issuer, we would expect to incur increased expenses to remain compliant with the applicable SEC and Nasdaq requirements.

Other Income, Net

Other income (expense), net consists primarily of sublease income and gains or losses arising from the termination of leases.

Foreign exchange (losses) gains, net

Foreign exchange (losses) gains, net consist of foreign currency transaction gains and losses arising from transactions denominated in foreign currencies.

Other income, net consists primarily of sublease income and gains or losses arising from the termination of leases.

Foreign Exchange Gains (Losses), Net

Foreign exchange gains (losses), net consist of foreign currency transaction gains and losses arising from transactions denominated in foreign currencies.

Interest Income

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Interest Expense, Net

Interest expense, net consists primarily of interest expense arising from amortization of the liabilities related to future royalties and milestones, pursuant to our collaboration agreements with Blackstone and BioNTech, using the effective interest rate method.

Interest expense, net consists primarily of interest expense arising from amortization of the liabilities related to future royalties and milestones, pursuant to our collaboration agreements with BXLS V - Autobahn L.P, (“Blackstone”) and BioNTech SE (“BioNTech”), using the effective interest rate method.

On a quarterly basis, we assess the expected present value of the future Blackstone and BioNTech payments under the Blackstone Collaboration Agreement and BioNTech Agreements which may be received by us and future royalties and sales milestone payments to Blackstone and BioNTech which may be paid by us.

To the extent the amount or timing of such receipts or payments is materially different than our previous estimates we record a cumulative catch-up adjustment to the liabilities related to future royalties and milestones.

The adjustment to the carrying amount is recognized as an adjustment to interest expense in the period in which the change in estimate occurred.

Income Tax (Expense) Benefit

We are subject to corporate taxation in the U.K., U.S., Germany and Switzerland.

Adjustments to increase or decrease the carrying amount are recognized as an adjustment to interest expense, net in the period in which the change in estimate occurred.

Income Tax Expense

We are subject to corporate taxation in the United Kingdom, United States, Germany and Switzerland.

Due to the nature of our business, we have generated losses since inception.

Our income tax (expense) benefit recognized represents the sum of income tax payable or receivable in the U.K.

and in the U.S.

Our income tax (expense) benefit recognized represents the sum of income tax payable or receivable in the United Kingdom and in the United States.

Un-surrendered U.K.

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Selling, general and administrative expenses (131,874) (101,723) (30,151) 30 %

Loss on disposal of leasehold improvements (223) (3,791) 3,568 (94) %

Impairment of operating lease right-of-use assets and related property and equipment

(414) (382) (32) 8 %

Loss from operations

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515 220 295 134 %

Foreign exchange (losses) gains, net

Foreign exchange gains (losses), net

2,163 (989) 3,152 (319) %

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Net loss before income tax (285,556) (219,134) (66,422) 30 %

Income tax (expense) benefit

(1,528) 19 (1,547) (8142) %

Income tax expense (1,972) (1,528) (444) 29 %

$ (287,528) $ (220,662) $ (66,866) 30 %

Product Revenue, Net

During the year ended December 31, 2025, we generated product revenue, net amounting to $74.3 million, from the sale of AUCATZYL in the United States.

We did not generate any product revenue for the year ended December 31, 2024, as AUCATZYL was approved by the FDA for commercial use on November 8, 2024 and was not launched in the U.S.

market until 2025.

License Revenue

License revenue amounting to $10.1 million for the year ended December 31, 2024 related to license revenue recognized pursuant to the License and Option Agreement with BioNTech.

License revenue of $1.7 million for the year ended December 31, 2023 primarily related to the execution of the Cabaletta Bio Inc.

(“Cabaletta”) Option and License Agreement, which included recognition of a non-refundable license fee and license revenue from an investee of Syncona Portfolio Limited, which is a holder of more than 10% of our share capital.

License revenue amounting to $1.1 million for the year ended December 31, 2025 related primarily to license revenue recognized pursuant to the License and Option Agreement with Moderna.

During the year ended December 31, 2025, we were notified by Moderna of the achievement of a clinical milestone of $1.0 million relating to one of our proprietary binders that was licensed in 2022.

License revenue of $10.1 million for the year ended December 31, 2024 primarily related to license revenue recognized pursuant to the License and Option Agreement with BioNTech.

Cost of Sales

Cost of sales amounting to $11.4 million was recognized from November 8, 2024, the date of the FDA approval of AUCATZYL, to December 31, 2024, consisting primarily of salaries and other employment related costs, including share-based compensation expense, for employees engaged in manufacturing activities related to AUCATZYL, as well as outsourced professional services.

Cost of sales increased by $85.0 million to $96.4 million for the year ended December 31, 2025 from $11.4 million for the year ended December 31, 2024 relating to increase in salaries and other employment related costs, including share-based compensation expense, for employees engaged in manufacturing activities related to AUCATZYL, as well as outsourced professional services.

It also consisted of direct production costs relating to commercial product manufactured, and allocated facility costs including maintenance, depreciation, utilities and rent.

Research and Development Expenses

Cost of sales was recognized from November 8, 2024, the date of the FDA approval of AUCATZYL.

Certain manufacturing expenses incurred prior to AUCATZYL receiving the FDA approval were classified as research and development expenses, resulting in zero cost related to inventory.

If cost of sales included previously expensed inventories, the total cost of sales with these manufacturing costs included would have increased by approximately $8.7 million for the year ended December 31, 2025.

Research and Development Expenses, Net

The following tables provide additional detail on our R&D expenses (in thousands):

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Direct research and development expenses

B cell malignancies (Obe-cel, AUTO1/22 & AUTO3)

B cell malignancies (Obe-cel & AUTO1/22)

$ 13,807 57 %

Other projects (AUTO4, AUTO5, AUTO6, AUTO7 & AUTO8)

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40,769 26,373 14,396 55 %

Research and development expense and unallocated costs:

Indirect research and development expenses and unallocated costs:

Personnel related (including share-based compensation)

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19,651 37,734 (18,083) (48) %

Total research and development expenses

Total Research and Development Expenses, Net

$ 117,689 $ 138,436 $ (20,747) (15) %

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research and development tax credits

Research and development expenses increased by $7.9 million to $138.4 million for the year ended December 31, 2024 from $130.5 million for the year ended December 31, 2023 primarily due to:

• an increase of $12.0 million in salaries and other employment related costs including share-based compensation expense, which was mainly driven by an increase in the number of employees engaged in research and development activities;

• an increase of $3.6 million in clinical trial costs, manufacturing costs and material transportation costs relating to research and development activities;

• a decrease of $5.2 million in legal fees and professional consulting fees in relation to our research and development activities;

• a decrease of $2.2 million related to our information technology infrastructure and support for information systems related to our research and development activities and facilities offset by an increase in depreciation and amortization related to property and equipment;

• an increase of $0.3 million in U.K.

R&D tax credits (decrease in R&D expense) due primarily to an increase in qualifying research and development expenditures related to the SME scheme.

Research and development expenses, net decreased by $20.7 million to $117.7 million for the year ended December 31, 2025 from $138.4 million for the year ended December 31, 2024 primarily due to:

• a decrease of $22.2 million related to our information technology infrastructure, support for information systems, facility costs and depreciation, including the allocation of expense from research and development to cost of sales and inventories related to commercial manufacturing following the FDA approval of AUCATZYL in November 2024;

• a decrease of $19.3 million in salaries and other employment related costs including share-based compensation expense, which was mainly driven by the reallocation of employees to commercial manufacturing activities included in cost of sales and inventories;

• a decrease of $15.1 million in U.K.

R&D tax credits (increase in R&D expense) due primarily to a decrease in qualifying research and development expenditures;

• an increase of $4.4 million in research and development activities including, clinical manufacturing costs, clinical CRO costs and other related activities;

• an increase of $1.3 million in legal fees and professional consulting fees in relation to our research and development activities.

Selling, General and Administrative Expenses

Selling, general and administrative expenses increased by $30.2 million to $131.9 million for the year ended December 31, 2025 from $101.7 million for the year ended December 31, 2024 primarily due to:

• an increase of $29.1 million in salaries and other employment related costs including share-based compensation expenses, which was mainly driven by an increase in the number of employees engaged in general and administrative activities;

• an increase of $22.1 million in commercial readiness costs including legal and professional fees due to increased commercial readiness activities being undertaken;

• an increase of $3.1 million in information technology infrastructure and support for information systems and facility costs relating related to the conduct of corporate and commercial operations and the increase in space utilized for general and administrative activities and related to general office expenses.

Loss on Disposal of Property and Equipment

For the year ended December 31, 2024, a loss on disposal of $0.2 million was recognized related to a manufacturing facility in Stevenage, U.K that we exited.

For the year ended December 31, 2023, we recognized a loss on disposal of property and equipment of $3.8 million related to fixed assets no longer being utilized in the manufacturing facility exited in Stevenage, United Kingdom.

Foreign Exchange (Losses) Gains, Net

Foreign exchange (losses) gains, net decreased to a loss of $1.0 million for the year ended December 31, 2024 from a gain of $2.6 million for the year ended December 31, 2023.

• an increase of $20.4 million in salaries, other employment related costs and termination benefits including share-based compensation expenses, which was mainly driven by an increase in the number of employees engaged in general and administrative activities;

• an increase of $6.9 million in information technology infrastructure and support for information systems, facility costs, depreciation and impairment on right of use assets and related property and equipment relating to the conduct of corporate and commercial operations including increase in space utilized for these activities;

• an increase of $2.9 million in commercial costs, including legal and professional fees due to increased activity in support of U.S.

and international market access;.

Foreign Exchange Gains (Losses), Net

Foreign exchange gains (losses), net increased to a gain of $2.2 million for the year ended December 31, 2025 from a loss of $1.0 million for the year ended December 31, 2024.

The (loss)/gain arises on a variety of items, including on U.S.

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Interest Income

Interest income increased to $32.4 million for the year ended December 31, 2024, as compared to $13.5 million for the year ended December 31, 2023.

The increase in interest income of $18.9 million primarily relates to higher account balances associated with our cash, cash equivalents and marketable securities during the year ended December 31, 2024 as compared to the year ended December 31, 2023.

Interest income decreased to $19.0 million for the year ended December 31, 2025, as compared to $32.4 million for the year ended December 31, 2024.

The decrease in interest income of $13.4 million primarily relates to lower aggregate balances and yield associated with our cash, cash equivalents and available-for-sale securities during the year ended December 31, 2025 as compared to the year ended December 31, 2024.

Interest Expense, Net

Interest expense, net decreased to $9.3 million for the year ended December 31, 2024 as compared to $45.1 million for the year ended December 31, 2023.

Interest expense, net decreased by $35.8 million primarily due to changes in the assumptions used in the valuation of the Collaboration Agreement with Blackstone and the BioNTech License and Option Agreement for the year ended December 31, 2024 compared to the year ended December 31.

Interest expense, net increased to $36.7 million for the year ended December 31, 2025 as compared to $9.3 million for the year ended December 31, 2024.

Interest expense, net increased by $27.4 million primarily due to changes in the assumptions used in the valuation of the Collaboration Agreement with Blackstone and the BioNTech License and Option Agreement for the year ended December 31, 2025 compared to the year ended December 31, 2024.

Income Tax Expense

Income tax expense increased to $2.0 million for the year ended December 31, 2025 as compared to $1.5 million for the year ended December 31, 2024.

Income tax expenses increased by $0.4 million primarily due to an increase in Autolus Inc.'s taxable income due to the recognition of product revenue, net and related intra-group recharges during the year ended December 31, 2025 compared 2024.

Liquidity and Capital Resources

Since our inception, we have not generated any commercial product revenue and have incurred operating losses and negative cash flows from our operations.

Since our inception, we have incurred operating losses and negative cash flows from our operations.

We expect to incur significant expenses and operating losses for the foreseeable future as we market AUCATZYL and advance our other product candidates through preclinical and clinical development and seek regulatory approval and pursue commercialization of any additional approved products.

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As of November 8, 2024, we have one product approved for commercial sale in the United States, AUCATZYL, of which the first commercial sale of AUCATZYL in the United States was made during January 2025.

We have funded our operations to date primarily with proceeds from government grants, sales of our equity securities, through public offerings and pursuant to our at-the-equity market facility, through U.K.

research and development tax credits and receipts from the SME and RDEC schemes, out-licensing arrangements and strategic collaboration and financing agreements.

We have funded our operations to date primarily with proceeds from government grants, sales of our equity securities including ADSs, through public offerings and pursuant to our at-the-market equity facility, through U.K.

research and development tax credits and receipts from the SME and RDEC schemes, out-licensing arrangements, strategic collaboration agreements and sale of our commercial product.

From our inception in 2014 through December 31, 2025 , we have raised an aggregate of $1.8 billion from these capital sources.

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Net cash used in operating activities $ (283,568) $ (206,271)

Net cash used in investing activities (394,552) (10,986)

Net cash provided by (used in) financing activities

589,554 (883)

Net cash provided by (used in) investing activities 158,458 (394,552)

Net cash (used in) provided by financing activities (4,339) 589,554

Effect of exchange rate changes on cash, cash equivalents and restricted cash 6,279 (261)

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During the year ended December 31, 2025, operating activities used $283.6 million of cash, resulting from our net loss of $287.5 million, and net cash used resulting from changes in our operating assets and liabilities of $52.0 million, partially offset by non-cash charges of $55.9 million.

The non-cash charges related to interest expense accrued and cumulative catch-up adjustment of $36.4 million, share-based compensation of $14.4 million, inventory reserves and write-offs of $12.3 million, depreciation and amortization of $9.8 million and an impairment of operating lease right-of-use assets and related property and equipment of $0.3 million, which is offset by amortization of available-for-sale securities of $8.2 million, non-cash operating lease expense of $5.7 million, foreign exchange differences of $3.1 million and deferred income tax movement of $0.3 million.

Net cash used in operating activities resulting from changes in our operating assets and liabilities for the year ended December 31, 2025 consisted primarily of an increase in inventories of $40.2 million, an increase in accounts receivable of $24.1 million and an increase in increase in prepaid expenses and other current and non-current assets of $4.6 million, offset by an increase of $14.6 million in operating lease liabilities, an increase in accounts payable of $1.3 million, and an increase in accrued expenses and other liabilities of $1.0 million,

During the year ended December 31, 2024, operating activities used $206.3 million of cash, resulting from our net loss of $220.7 million, and net cash used resulting from changes in our operating assets and liabilities of $23.6 million, partially offset by non-cash charges of $38.0 million.

The non-cash charges related to interest expense accrued and cumulative catch-up adjustment of $8.9 million, share-based compensation of $15.5 million, depreciation and amortization of $7.6 million, non-cash operating lease expense of $4.7 million, foreign exchange differences of $1.9 million, impairment of operating lease right-of-use assets and related property and equipment of $0.4 million, loss on disposal of leasehold improvements of $0.2 million, and loss on termination of operating lease of $0.2 million which is partially offset by accretion of available-for-sale securities of $1.2 million and a deferred income tax movement of $0.2 million.

Net cash used in operating activities resulting from changes in our operating assets and liabilities for the year ended December 31, 2024 consisted primarily of an increase in accrued expenses and other liabilities of $11.9 million, an increase in accounts payable of $1.6 million, offset by a $32.5 million increase in prepaid expenses and other current and non-current assets, an increase in inventories of $4.2 million, and a decrease in a $0.4 million in operating lease liabilities.

During the year ended December 31, 2023, operating activities used $145.6 million of cash, resulting from our net loss of $208.4 million, partially offset by net cash used resulting from changes in our operating assets and liabilities of $0.3 million and non-cash charges of $62.5 million.

The non-cash charges related to interest expense accrued and cumulative catch-up adjustment of $45.0 million, share-based compensation of $11.2 million, depreciation and amortization of $6.6 million, non-cash operating lease expense of $4.1 million, loss on disposal of leasehold improvements of $3.8 million, impairment of operating lease right-of-use assets and related property and equipment of $0.4 million and loss on termination of operating lease of $0.1 million which is partially offset by foreign exchange differences of $7.6 million and a deferred income tax movement of $1.0 million.

Net cash used in operating activities resulting from changes in our operating assets and liabilities for the year ended December 31, 2023 consisted primarily of a decrease in a $13.6 million in operating lease liabilities and a decrease in accounts payable of $0.5 million, offset by a $12.4 million decrease in prepaid expenses and other current and non-current assets, a decrease in long-term deposits of $0.9 million and an increase in accrued expenses and other liabilities of $1.0 million.

Net Cash Used In Investing Activities

Net Cash Provided By (Used In) Investing Activities

During the year ended December 31, 2025, net cash provided by investing activities was $158.5 million , including proceeds from maturities and redemptions of marketable securities:

available-for-sale debt securities of $428.2 million, offset by, purchases of marketable securities:

available-for-sale securities of $242.6 million, purchases of property and equipment of $19.0 million, and acquisition of intangible assets of $8.1 million.

During the year ended December 31, 2024, we used $394.5 million of cash in investing activities, including purchases of marketable securities of $359.7 million, purchases of property and equipment of $22.1 million, and acquisition of intangible assets of $12.7 million.

During the year ended December 31, 2023 , we used $11.0 million of cash in investing activities which consisted primarily of purchases of property and equipment.

Net Cash Provided By (Used In) Financing Activities

During the year ended December 31, 2024, net cash provided financing activities was $589.6 million related to net aggregate proceeds raised from the BioNTech Agreements, our underwritten offering of ADSs and a Blackstone Development Payment paid by Blackstone to us upon the FDA approval of AUCATZYL.

During the year ended December 31, 2023, net cash used in financing activities was $0.9 million which pertains primarily to payments of equity issuance costs relating to a prior equity financing transaction..

Net Cash (Used In) Provided By Financing Activities

During the year ended December 31, 2025, net cash used in financing activities was $4.3 million related to revenue share payments.

During the year ended December 31, 2024, net cash provided by financing activities was $589.6 million related to net aggregate proceeds raised from the BioNTech Agreements, our underwritten offering of ADSs and a Blackstone Development Payment paid by Blackstone to us upon the FDA approval of AUCATZYL.

Funding Requirements

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Our future funding requirements will depend on and could increase significantly as a result of many factors, including:

• our ability to continue to execute our commercialization strategies for AUCATZYL and, if approved, our other product candidates;

• our ability to continue to execute our commercialization strategies for AUCATZYL and, if approved, any of our other product candidates for which we may receive regulatory approval;

• the scope, progress, outcome and costs of our clinical trials and other research and development activities;

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• the extent to which we in-license or acquire additional product candidates or technologies.

research and development tax credits and receipts from the SME and RDEC schemes, out-licensing agreements, or strategic collaboration agreements.

Until such time, if ever, that we can generate product revenue sufficient to achieve profitability, we expect to finance our cash needs through a combination of public or private equity offerings, reimbursable United Kingdom research and development tax credits and receipts from the RDEC scheme, out-licensing agreements, or strategic collaboration agreements.

To the extent that we raise additional capital through the sale of equity, the ownership interest of existing shareholders will be diluted.

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Payments due upon cancellation consist only of payments for services provided or expenses incurred, including noncancellable obligations of our service providers, up to the date of cancellation.

As of December 31, 2024, our unconditional purchase obligations for capital expenditures totaled $17.5 million and included signed orders for capital equipment and capital expenditure for construction and related expenditure relating to our properties in the U.K.

and the United States.

As of December 31, 2025, our unconditional purchase obligations for capital expenditures totaled $1.8 million and included signed orders for capital equipment and capital expenditure for construction and related expenditure relating to our properties in the United Kingdom.

We expect to incur the full amount of these obligations within one year.

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These payments include (i) an upfront payment of $50 million and (ii) up to $100 million payable based on the achievement of certain specified clinical, manufacturing and regulatory milestones (each such payment, a “Blackstone Development Payment” and collectively, the “Blackstone Development Payments”).

In exchange for the Blackstone Development Payments, we agreed to make payments to Blackstone (the “Revenue Share Payments”) equal to a mid-single digit royalty, subject to the Aggregate Cap (as defined in the Blackstone Collaboration Agreement) on payments under the Blackstone Collaboration Agreement, based on net sales anywhere in the world of (i) Collaboration Products in B-cell malignancies, (ii) subject to certain conditions set forth in the Blackstone Collaboration Agreement, its CD19 and CD22 CAR T cell investigational therapy product candidate known as AUTO3 in B-cell malignancies, and (iii) certain Collaboration Products to the extent developed or commercialized in indications other than a B-cell malignancy (“Obe-cel Franchise Products”).

We are also obligated to make payments (the “Sales Milestone Payments”), subject to the Aggregate Cap, if certain cumulative net sales levels are achieved.

We are also obligated to make payments, subject to the Aggregate Cap, if certain cumulative net sales levels are achieved.

In November 2021, the upfront payment of $50 million was paid by Blackstone upon execution of the Blackstone Collaboration Agreement.

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Similarly, the BioNTech Liability is measured based on our current estimates of the timing and amount of expected future royalty expected to be paid over the estimated term of the agreement.

Milestone payments (“BioNTech Milestone Payments”) pursuant to the BioNTech License and Option Agreement are payable upon BioNTech's election, and therefore have not been included in the determination of the effective interest rate or in the measurement of the liability.

Milestone payments pursuant to the BioNTech License and Option Agreement are payable upon BioNTech's election, and therefore have not been included in the determination of the effective interest rate or in the measurement of the liability.

The liabilities are amortized using the effective interest rate, resulting in recognition of interest expense over the estimated term of the agreement.

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The excess or deficit of estimated present value of future royalty, milestone payments and the future Blackstone Development Payment received over the carrying amount is recognized as a cumulative catch-up adjustment within interest expense, net using the effective interest rate.

Expected rebate and chargeback percentage for product revenue deductions

Since approval of AUCATZYL in the United States in November 2024, we have a short history of actual rebate claims or chargebacks, and such information may have limited predictive value.

We use the expected value method to estimate expected rebate and chargeback percentages for revenue deductions, which considers the likelihood of a rebate or chargeback being applicable to sales.

The proportion of sales subject to a rebate or chargeback is inherently uncertain and estimates are based on internal assumptions, which may change as we develop more product experience, and third-party data, which we assess for reliability and relevance.

We are subject to state government Medicaid programs and other qualifying federal and state programs in the United States requiring rebates to be paid to participating state and local government entities, depending on the eligibility and circumstances of patients treated with AUCATZYL.

Our wholly-owned subsidiary in the United States also participates in programs with government entities, the most significant of which are the DoD and the VA, and other parties, including covered entities under the 340B Program, whereby pricing on AUCATZYL is extended below list price to participating entities, including ATCs.

These entities are entitled to purchase AUCATZYL at the lower program price by charging the Company the difference between their acquisition cost and the lower program price.

Estimating expected rebate and chargeback percentages for revenue deductions is judgmental due to the time delay between the date of the sale to ATCs and the subsequent dates on which we are able to determine actual amounts of chargebacks and rebates.

We form estimates of the 340B Program, the DoD and the VA chargeback deductions by analyzing sell-through data relating to the hospital mix of onward sales made by ATCs.

For Medicaid and Tricare, we form estimates based on information obtained from claims received, historical and estimated payor mix, setting of care, discount rates and other industry data, and external health coverage statistics.

Judgment is applied to consider the relevance and reliability of information used to make these estimates.

Total product revenue deductions for the year ended December 31, 2025 of $7.6 million were related to critical estimates subject to significant estimation uncertainty and judgment, as described above.

We recorded $5.0 million within accrued expenses and other current liabilities in the consolidated balance sheet related to these deductions as of December 31, 2025.

We believe our expected values of accruals reported in the consolidated balance sheet are materially appropriate;

however, due to the uncertainties and judgments outlined above, it is possible eventual amounts could significantly differ to these estimates.

Recently Issued Accounting Pronouncements

A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2, “Summary of Significant Accounting Policies,” to our consolidated financial statements included in in this Annual Report.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis