Autolus Therapeutics plc
For the period ended Dec 31, 2024. Filed Mar 20, 2025.
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FY2024 · Filed Mar 20, 2025
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Notes to Consolidated Financial Statements F-
Notes to Consolidated Financial Statements
Note 1. Nature of the Business
Autolus Therapeutics plc (with its subsidiaries, collectively, “Autolus” or the “Company”) is an early commercial-stage biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer and autoimmune diseases. Using its broad suite of proprietary and modular T cell programming technologies, the Company is 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. The Company believes its 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. On November 8, 2024 Autolus was notified by the U.S. Food and Drug Administration (the “FDA”) that its biologics license application (“BLA”) was approved, allowing for the marketing of AUCATZYL (obecabtagene autoleucel, also known as obe-cel) in the US for the treatment of adult patients (18 years and older) with r/r B-ALL. Obe-cel is under regulatory review in both the European Union (the “EU”) and the United Kingdom (the “U.K.”) for the treatment of r/r B-ALL, with marketing authorization submissions accepted by the European Medicines Agency (“EMA”) in April 2024, and the U.K. Medicines and Healthcare products Regulatory Agency (“MHRA”) in August 2024. The Company expects to receive notification of approval status from these authorities in the second half of 2025. The commercial launch and first sale of AUCAZTYL in the US occurred in January 2025.
Autolus Therapeutics plc is registered in England and Wales. Its registered office is The MediaWorks, 191 Wood Lane, London, W12 7FP, United Kingdom.
The Company is subject to risks and uncertainties common to companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. The Company’s product candidates currently under development will require significant additional research and development efforts, including preclinical and clinical testing and regulatory approval, prior to commercialization. Although AUCATZYL has been granted marketing approval in the US by the FDA, the Company will continue to incur significant additional costs to commercialize it. These efforts will require significant amounts of capital, as well as additional personnel, infrastructure, and compliance capabilities. Even if the Company’s product development efforts for obe-cel and its other product candidates are successful, it is uncertain when, if ever, the Company will become profitable.
The Company is a public limited company incorporated under the laws of England and Wales, and qualifies as a “foreign private issuer,” as such term is defined in Rule 405 under the Securities Act of 1933, as amended (the “Securities Act”), and Rule 3b-4 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and, therefore, is not subject to the same requirements that are imposed upon U.S. domestic issuers by the Securities and Exchange Commission (the “SEC”). The Company has decided to voluntarily file periodic reports, such as annual reports on Form 10-K, quarterly reports on Form 10-Q, and current reports on Form 8-K on U.S. domestic issuer forms, which are more detailed and extensive in certain respects, and which must be filed more promptly than the forms currently required for foreign private issuers. Although the Company has voluntarily chosen to file periodic reports and current reports on U.S. domestic issuer forms, the Company will maintain its status as a foreign private issuer and is not subject to certain other requirements imposed on U.S. domestic issuers including its officers, directors, and principal shareholders are not subject to the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange Act.
On February 6, 2024 (the “Execution Date”), the Company concurrently entered into a (i) Securities Purchase Agreement (the “BioNTech Securities Purchase Agreement”), (ii) a Registration Rights Agreement (the “BioNTech Registration Rights Agreement”), (iii) a Letter Agreement (the “BioNTech Letter Agreement”) and (iv) a License and Option Agreement (the “BioNTech License and Option Agreement”), collectively called the “BioNTech Agreements”, with BioNTech. The BioNTech Agreements were entered into and in contemplation of one another and, accordingly, the Company assessed the accounting for these agreements in the aggregate. The following descriptions of the BioNTech Agreements do not purport to be complete and are qualified in their entirety by reference to the full text of such agreements.
(i) BioNTech Securities Purchase Agreement
Pursuant to the BioNTech Securities Purchase Agreement the Company sold to BioNTech ADSs, each representingone ordinary share with a nominal value of $0.000042 per share, of the Company (the “Ordinary Shares”) in a private placement transaction (the “Private Placement”). On February 13, 2024, the Company completed the Private Placement of 33,333,333 ADSs(the “Initial ADSs”), representing 33,333,333 Ordinary Shares at an offering price of $6.00 per Initial ADS. Aggregate net proceeds to the Company, after underwriting discounts and offering expenses, were $193.8 million.
In the event that BioNTech and the Company enter into a Manufacturing and Commercial Services Agreement (as defined below) within 18 months of the initial closing of the Private Placement, BioNTech will purchase additional ADSs (the “Subsequent ADSs” and, together with the Initial ADSs, the “Private Placement ADSs”), not to exceed 15,000,000 ADSs, for an aggregate purchase price of up to $20.0 million. The total number of Subsequent ADSs that may be issued is subject to additional limitations and restrictions.
The BioNTech Securities Purchase Agreement contains customary representations, warranties, and covenants of each of the Company and BioNTech.
(ii) BioNTech Registration Rights Agreement
Pursuant to the BioNTech Registration Rights Agreement the Company agreed to file a registration statement with the SEC to register the resale of the Private Placement ADSs.
(iii) BioNTech Letter Agreement
The BioNTech Letter Agreement provides BioNTech with certain additional rights and subjects BioNTech’s investment in the Company to certain restrictions. BioNTech received the right to nominate a director to the Company’s board of directors. If BioNTech acquires beneficial ownership of at least 30% of the issued and outstanding Ordinary Shares of the Company (including in the form of ADSs) within five years of the Execution Date, BioNTech will have the right to designate an additional director who shall be independent. BioNTech’s director nomination rights shall automatically terminate upon BioNTech’s ownership of Ordinary Shares dropping below certain specified percentages. Additionally, BioNTech has the right to purchase equity securities sold by the Company in bona fide financing transactions in amounts that are based on BioNTech maintaining specified ownership thresholds following such financing transactions.
Subject to specified exceptions, BioNTech may not sell the Private Placement ADSs without the Company’s approval for a period ofsix months following the applicable closing date for such ADSs.
The BioNTech Letter Agreement terminates upon the earlier of (a) the later of (i) February 6, 2027 and (ii) such time as no securities of the Company are held by BioNTech or its affiliates and (b) the consummation of a change of control transaction involving the Company.
(iv) BioNTech License and Option Agreement
The Company, through its wholly owned subsidiaries, Autolus Limited and Autolus Holdings (U.K.) Limited, entered into the BioNTech License and Option Agreement with BioNTech pursuant to which the Company granted to BioNTech:
an exclusive, worldwide, sublicensable license (the “Binder License”) to certain binders and to exploit products that express in vivo such binders (collectively, the “Binder Licensed Products”), and
several time-limited options (the “Options”) to acquire additional rights to specified clinical-stage product candidates, binders and technologies of the Company, described in more detail below:
an option to obtain exclusive rights to co-fund development costs of the Company’s development-stage programs AUTO1/22 and AUTO6NG (“Product Options”), in return for agreed upon economic terms, including an option exercise fee, milestone payments and a profit-sharing arrangement for each such product candidate, with additional options to co-promote or co-commercialize each such product candidate. The product option for AUTO1/22 was not exercised and has expired as of February 8, 2025;
an option to obtain an exclusive worldwide license to exploit products that express certain additional binders in vivo or, with respect to certain binders, in an antibody drug conjugate (the “Binder Option”);
an option to obtain a co-exclusive worldwide license to exploit products that express in vivo the Company’s modules for activity enhancement, with a non-exclusive right, in certain agreed instances, to exploit products that include Company’s modules for activity enhancement but do not express in vivo such modules (the “Activity Enhancement Option”); and
an option to obtain a non-exclusive worldwide license to exploit products that contain the Company’s safety switches (the “Safety Switch Option” and, together with the Binder Option and the Activity Enhancement Option, the “Technology Options”).
In consideration for the Binder License and the Technology Options, BioNTech made an initial payment to the Company of $10.0 million. In the event that all Options are fully exercised, the Company would be eligible to receive maximum aggregate payments of up to $582.0 million pursuant to the License Agreement. This maximum amount includes the potential milestone payments for the Binder Licensed Products described below, all option exercise fees and potential milestone payments for licenses to optioned products and technologies, and additional payments that BioNTech may pay to the Company for an increased revenue interest with respect to the Company’s product candidate obe-cel as described below.
The option exercise fee for each Technology Option is a low seven-digit amount. Each of the Activity Enhancement Option and the Safety Switch Option must be exercised with respect to a given biological target or combination of targets. There is a cap on the total option exercise fee if multiple options are exercised with respect to a given target. There is also a cap on milestone payments across all agreements entered into as the result of BioNTech exercising one or more of the Technology Options and a cap on the royalty rate payable on any given product for which multiple Options are exercised.
Under the License Agreement, BioNTech has also agreed to financially support the expansion of the clinical development program and planned commercialization of obe-cel (through a revenue sharing arrangement). In exchange for the grant of rights to future revenues from the sales of obe-cel products, BioNTech made an upfront payment to us of $40.0 million. The Company 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 $100.0 million in the aggregate on achievement of certain regulatory events for specific new indications upon BioNTech's election. The Company expects to make initial payments of the revenue interest to BioNTech in 2025.
Manufacturing and Commercial Services Agreement
Under the terms of the BioNTech License and Option Agreement, the Company has agreed to grant BioNTech the option to negotiate a joint manufacturing and commercial services agreement pursuant to which the parties may access and leverage each other’s manufacturing and commercial capabilities, in addition to Autolus’ 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 Services Agreement” or “MCSA”). The MCSA, if entered into, would also grant BioNTech access to the Company’s commercial site network and infrastructure.
The Company concluded there were four freestanding financial instruments arising from the execution of the BioNTech Agreements, comprising:
the Initial ADSs representing ordinary shares purchased pursuant to the BioNTech Securities Purchase Agreement;
the potential Subsequent ADSs representing ordinary shares that may be purchased pursuant to the BioNTech Securities Purchase Agreement;
the BioNTech License and Option Agreement, and
the MCSA.
The Subsequent ADSs are classified as a forward instrument contingent on the MCSA being executed. As of December 31, 2024, the MCSA had not been entered into. The forward instrument has an inconsequential market value as the exercise price approximates the Company’s stock price on the last trading day prior to the signing date of the MCSA. Consequently, the initial proceeds arising from the purchase of Initial ADSs pursuant to the BioNTech Securities Purchase Agreement will not be separately allocated to this freestanding financial instrument at inception of the BioNTech Agreements. Furthermore, as the MCSA has yet to be entered into no consideration will be allocated to this freestanding financial instrument at inception of the BioNTech Agreements.
Within the BioNTech License and Option Agreement, there are a number of embedded features which have each been assessed for freestanding financial instrument accounting in accordance with Accounting Standards Codification (“ASC”) 480–Distinguishing Liabilities from Equity. Although these embedded features are separately exercisable, they lack legal detachability and, therefore, the BioNTech License and Option Agreement is accounted for asone freestanding financial instrument. However, each embedded feature is assessed for derivative accounting in accordance to ASC 815–Derivative and Hedging(“ASC 815”).
The Company analyzed how it should account for the host contract (i.e., the BioNTech License and Option Agreement) as the Binder License represents an agreement with customer for goods and services and therefore should be accounted for under ASC 606 –Revenue from Contracts with Customers(“ASC 606”). However, as the other embedded features of the BioNTech License and Option Agreement fall under the scope of other topics that specify how to initially measure the contract (i.e., ASC 470 –Debt(“ASC 470”)), the Company determined that the host contract should not be accounted for and initially measured pursuant to ASC 606. Furthermore, the Company determined the host contract (the BioNTech License and Option Agreement) met the scope exception of ASC 815-10-15-59(d) and therefore should not be accounted for as a derivative under ASC 815 but instead be accounted for as a debt financial instrument in accordance with ASC 470.
Thefour units of accounting were recorded at fair value upon initial recognition and will not be subsequently measured at fair value. The Company allocated the total gross proceeds arising from the BioNTech Securities Purchase Agreement (i.e., the Initial ADSs representing ordinary shares), and the BioNTech License and Option Agreement among thefour units of accounting on a relative fair value basis at the time of the transaction as follows:
| Units of Accounting | Gross proceeds (in millions) | Initial fair value (in millions) | Allocated consideration based on relative fair value (in millions) | Net allocated consideration based on relative fair value after transaction costs*(in millions) |
|---|---|---|---|---|
| Initial ADSs, representing ordinary shares | $200.0 | $200.0 | $200.0 | $193.8 |
| Subsequent ADSs, representing ordinary shares | $— | $— | $— | $— |
| BioNTech License and Option Agreement | $50.0 | $50.0 | $50.0 | $47.9 |
| Liabilities related to future royalties and milestones, net (Obe-cel Product Revenue Interest) | $40.0 | $40.0 | $40.0 | $38.3 |
| License Revenue (Binder License) | $10.0 | $10.0 | $10.0 | $9.6 |
| MCSA | $— | $— | $— | $— |
| Total | $250.0 | $250.0 | $250.0 | $241.7 |
| * In addition, the total shared transaction costs of $8.3 million, relating to the BioNTech Agreements have been allocated to the four units of accounting on a relative fair value basis. | ||||
Note 2. Summary of Significant Accounting Policies
Basis of Presentation
The consolidated financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) and are presented in U.S. dollars. All intercompany accounts and transactions between the Autolus Therapeutics plc and its subsidiaries have been eliminated upon consolidation.
Going concern
In accordance with Accounting Standards Codification (“ASC”) 205-40, Going Concern, the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the consolidated financial statements are issued. Management considers that there are no conditions or events, in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern for a period of at least one year from the date the consolidated financial statements are issued.
The Company has incurred losses of $220.7 million and$208.4 million for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, the Company had an accumulated deficit of$1,099.2 million. The Company has funded its operations to date primarily with proceeds from the sale of its equity securities, including ADSs, licensing and collaboration arrangements and strategic financing. As the Company continues to incur losses, the transition to profitability is dependent upon the successful development, approval and commercialization of its product candidates and achieving a level of revenues adequate to support its cost structure. Even if the Company's planned regulatory submissions for its products are approved, and the Company is successful in its commercialization efforts, additional funding will be needed before the Company is expected to reach cash breakeven.
Use of estimates
The preparation of consolidated financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of income and expenses during the reporting periods. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the accrual for research and development expenses, share-based compensation including assessing the probability of meeting performance conditions, income taxes, initial fair value of warrants, and present value of liabilities related to future royalties and milestones, net including the related interest expense and cumulative catch-up adjustment, lease term of the Company’s manufacturing facility (“The Nucleus”), incremental borrowing rates related to the Company’s leased properties and allocation of transaction price using the relative standalone selling price. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from those estimates.
Segment Information
The Company’s chief operating decision maker (the “CODM”), its Chief Executive Officer and Executive Team members, manages the Company’s operations on an integrated basis for the purpose of appropriately allocating resources. When evaluating the Company’s financial performance, the CODM reviews total revenue, total expenses and expenses by function and makes decisions using this information on a global basis. The Company and the CODM view the Company’s operations and manage its business as a single operating and reportable segment, which is the business of developing and commercializing CAR T therapies.
Foreign Currency Translation
The reporting currency of the Company is in U.S. dollars. The Company has determined that its functional currency of the ultimate parent company, Autolus Therapeutics plc, is British Pound Sterling. The functional currency of each subsidiary’s operations is the applicable local currency. Monetary assets and liabilities denominated in currencies other than the Company’s functional currency are translated into the functional currency at rates of exchange prevailing at the balance sheet dates. Non-monetary assets and liabilities denominated in foreign currencies are translated into the functional currency at the exchange rates prevailing at the date of the transaction. Translation adjustments are not included in determining net income (loss) but are included in foreign currency translation to other comprehensive loss, a component of shareholders’ equity.
The Company recorded a foreign exchange loss of $1.0 million and a foreign exchange gain of $2.6 million for the years ended December 31, 2024 and 2023, respectively, which are included in foreign exchange (losses) gains in the consolidated statements of operations and comprehensive loss.
Fair Value Measurements
The Company uses valuation approaches that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines the fair value based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in of the following levels:
Level 1 — Quoted prices in active markets for identical assets or liabilities.
Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly.
Level 3 — Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability.
The carrying amounts reported in the consolidated balance sheet for cash and cash equivalents, restricted cash, prepaid expenses and other assets, accounts payable and accrued expenses and other liabilities approximate their fair value because of the short-term nature of these instruments.
Cash and cash equivalents
The Company considers all highly liquid investments with a maturity at acquisition date of three months or less to be cash equivalents. Cash and cash equivalents comprise cash balances, money market funds, commercial paper, U.K. government gilt, debt securities issued by foreign government and US treasury bills. Cash equivalents are primarily accessible on demand and have a weighted average maturity date of less than three months.
Restricted Cash
The Company's restricted cash consists of cash providing security for corporate credit cards, rental deposits relating to the sub-lease of facilities to third parties and cash deposited with a financial institution for the incorporation of the Company's newly incorporated Swiss subsidiary.
Marketable securities: available for sale debt securities
The Company invests excess cash balances in marketable debt securities. The Company classifies investments in marketable debt securities as available-for-sale. Management determines the appropriate classification of its investments in available-for-sale debt securities at the time of purchase and reevaluates such designation as of each reporting date. The Company reports available-for-sale debt securities at fair value at each balance sheet date, and includes any unrealized holding gains and losses (the adjustment to fair value) in accumulated other comprehensive income (loss), a component of shareholders’ equity. Realized gains and losses are determined using the specific-identification method, and are included in other income, net in the consolidated statements of operations and comprehensive loss. Interest income and amortization of premiums and discounts at acquisition are included in Interest income. The Company classifies available-for-sale debt securities as current or non-current based on management’s intentions.
The Company evaluates securities for impairment at the end of each reporting period. Impairment is evaluated considering numerous factors, and their relative significance varies depending on the situation. Factors considered include whether a decline in fair value below the amortized cost basis is due to credit-related factors or non-credit-related factors, the financial condition and near-term prospects of the issuer, and the Company's intent and ability to hold the investment to allow for an anticipated recovery in fair value. A credit-related impairment is recognized as an allowance on the balance sheet with a corresponding adjustment to earnings. Any impairment that is not credit- related is recognized in other comprehensive income (loss), net of applicable taxes.
Inventories, net
The Company commences capitalization of inventory once regulatory approval is received. Until this date, the Company expenses all such costs as incurred as research and development expenses. The Company capitalizes material costs, labor and applicable overheads that are incurred in the production of its commercial product. Inventory that can be used for either clinical, research or commercial purposes is classified initially as inventory. Inventory that is subsequently used in clinical trials or research activities is expensed once it has been used for research and development purposes.
On November 8, 2024, the Company received FDA approval for AUCATZYL and commenced capitalization of inventory from this date. There is no pre-launch inventory recognized on the balance sheet as of December 31, 2024.
Inventories are measured at the lower of cost or net realizable value, with cost determined using weighted average method for different components of inventory. The Company reviews the recoverability of inventory at each reporting period to determine any changes to net realizable value arising from excess, slow-moving or obsolete inventory. If net realizable value is lower than cost, the inventory will be written down to net realizable value and an impairment charge will be recognized in cost of sales.
Accounts receivable
Accounts receivable are recorded at the invoiced amount and do not bear interest. Amounts collected on accounts receivable are included in net cash used by operating activities in the consolidated statements of cash flows. Accounts receivable are recorded within prepaid expenses and other current assets on the balance sheet.
Property and Equipment, net
Property and equipment are recorded at cost and depreciated or amortized using the straight-line method over the estimated useful lives of the respective assets. As of December 31, 2024 and 2023, the Company’s property and equipment consisted of office equipment, lab equipment, furniture and fittings, and leasehold improvements.
Depreciation is computed using the straight-line method over the estimated useful lives of the related assets. The following table provides the range of estimated useful lives used for each asset type:
| Office equipment | 3 years |
|---|---|
| Lab equipment | 5 to 10 years |
| Furniture and fittings | 5 years |
| Leasehold improvements | shorter of the lease term or the estimated useful life of the asset |
Assets under construction consist of costs incurred with leasehold improvements and, once placed into service, will be depreciated over the shorter of the lease term or the estimated useful life of the asset. Upon retirement or sale, the cost of assets disposed of, and the related accumulated depreciation, are removed from the accounts and any resulting gain or loss is included in the statement of operations and other comprehensive loss.
Repairs and maintenance expenditures, which are not considered improvements and do not extend the useful life of property and equipment, are expensed as incurred. The Company routinely evaluates the useful life attributed to its assets.
Impairment of Long-Lived Assets
The Company evaluates an asset for potential impairment when events or changes in circumstances indicate the carrying value of the asset may not be recoverable. Recoverability is measured by comparing the carrying value of the asset to the expected future net undiscounted cash flows that the asset is expected to generate. If such asset is considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying value of the asset exceeds the fair value.
Intangibles
Milestone payments made to third parties either on or subsequent to regulatory approval are capitalized as an intangible asset and amortized over the remaining useful life of the product. During the year ended December 31, 2024 the Company recognized a license milestone payment $12.5 million as an intangible asset due to the technology having alternative future use in research and development projects at the time of the payment. The minimum annual royalties have been expensed as incurred.
Implementation Costs in a Cloud Computing Arrangement
The Company’s cloud computing arrangements primarily comprise hosting arrangements which are service contracts, whereby the Company gains remote access to use enterprise software hosted by the vendor or another third party on an as-needed basis for a period of time in exchange for a subscription fee. Implementation costs for cloud computing arrangements are capitalized if certain criteria are met and consist of internal and external costs directly attributable to developing and configuring cloud computing software for its intended use. These capitalized implementation costs are presented in the consolidated balance sheet in prepaid expenses and other assets, current and non-current, and are generally amortized over the fixed, non-cancellable term of the associated hosting arrangement on a straight-line basis.
Leases
At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present. Most leases with a term greater than one year are recognized on the balance sheet as right-of-use assets, lease liabilities and, if applicable, long-term lease liabilities. The Company has elected not to recognize on the balance sheet, leases with terms of one year or less. Instead, these lease payments are recognized in the statements of operations on a straight-line basis over the lease term. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected remaining lease term. However, certain adjustments to the right-of-use asset may be required for items such as incentives received, initial direct costs, or prepayments.
The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rates, which are the rates incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment.
In accordance with the guidance in Topic 842, Leases(“ASC 842”), components of a lease should be split into three categories: lease components (e.g., land, building, etc.) and non-lease components (e.g., common area maintenance, consumables, etc.). Many of the Company's leases contain variable non-lease components such as maintenance, taxes, insurance, and similar costs for the spaces it occupies. The Company expenses the variable lease payments in the period in which it incurs the obligation to pay such variable amounts and will be included in variable lease costs in the leases footnote disclosure. Then the fixed and in-substance fixed contract consideration (including any related to non-components) must be allocated based on the respective relative fair values to the lease components.
For new and amended leases, the Company has elected the practical expedients to account for the lease and non-lease components for leases for classes of all underlying assets and allocate all of the contract consideration to the lease component only. The Company determined the underlying lease to be the predominant component, and therefore, the entire agreement was accounted for under ASC 842.
The Company identified and assessed the following significant assumptions in recognizing its right-of-use assets and corresponding lease liabilities during the adoption of ASC 842:
As the Company's leases do not provide an implicit rate, it estimated the incremental borrowing rate for each lease based on a yield curve analysis, utilizing the interest rate derived from the fair value analysis of its existing leases and adjusting it for factors that appropriately reflect the profile of secured borrowing over the lease term. For leases existing as of the adoption date, the Company has utilized its incremental borrowing rate based on the remaining lease term as of the adoption date. For leases that commenced after the adoption date, the Company determined the incremental borrowing rate based on the lease term as determined at the commencement date of the lease.
The expected lease terms include both contractual lease periods and, when applicable, cancellable option periods where failure to exercise such options would result in an economic penalty.
Since the Company elected to account for the classes of underlying assets and its associated non-lease components as a single combined lease component, all contract consideration was allocated to the combined lease component.
Accrued Research and Development Expenses
As part of the process of preparing consolidated financial statements, the Company is required to estimate accruals for research and development expenses. This process involves reviewing and identifying services which have been performed by third parties on the Company’s behalf and determining the value of these services. In addition, the Company makes estimates of costs incurred to date but not yet invoiced, in relation to external clinical research organizations and clinical site costs. The Company analyzes the progress of clinical trials, including levels of patient enrollment; invoices received and contracted costs, when evaluating the adequacy of the accrued liabilities for research and development. The Company makes judgments and estimates in determining the accrued balance in any accounting period.
Liabilities related to future royalties and milestones, net and related interest expense accrued on liabilities related to future royalties and milestones, net and cumulative catch-up adjustment
The Company accounted for the Blackstone Collaboration Agreement (“Blackstone Collaboration Agreement Liability”) and the BioNTech Obe-cel Product Revenue Interest, (“BioNTech Liability”) as liabilities measured at amortized cost based on an effective interest rate determined at the outset of the arrangement. The Blackstone Collaboration Agreement Liability is measured based on the Company's current estimates of the timing and amount of expected future royalty and milestone payments to be paid and the Blackstone Development Payments expected to be received over the estimated term of the agreement. Similarly, the BioNTech Liability is measured based on the Company's 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.
The liabilities are amortized using the effective interest rate, resulting in recognition of interest expense over the estimated term of the agreement. Each reporting period the Company assesses the estimated probability, timing and amount of the future expected royalty, milestone payments, over the estimated term. If there are changes to the estimates, the Company recognize the impact to the liability’s amortization schedule and the related interest expense using the catch-up method. The imputed rate of interest on the unamortized portion of the Blackstone Collaboration Agreement Liability was approximately 15.80% as of December 31, 2024 and 2023, respectively. The imputed rate of interest on the unamortized portion of the BioNTech Liability was approximately 28.70% as of February 6, 2024, the execution date of the BioNTech Agreements and December 31, 2024 respectively.
The Company's estimate of the probability, timing and amount of expected future royalties and milestones to be paid by the Company, considers significant unobservable inputs. These inputs include regulatory approval, the estimated patient population, estimated selling price, estimated sales volumes, estimated peak sales and sales ramp, timing of the expected launch and its impact on the royalties as well as the overall probability of success. Additionally, the transaction costs associated with the liability will be amortized to interest expense over the estimated term of the agreements.
The carrying amount of the Blackstone Collaboration Agreement Liability and BioNTech Liability is based on the Company's estimate of the future royalties, milestones to be paid to Blackstone by the Company and the expected Blackstone Development Payment to be received over the life of the arrangement as discounted using the initial effective interest rate. On a quarterly basis, the Company assesses the amount and timing of expected royalty using a combination of internal projections and forecasts from external sources. 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.
The Company will recognize the relevant portion of royalties or sales milestones due to Blackstone and BioNTech upon the commercialization of AUCATZYL or other products as a decrease to the applicable liabilities, with a corresponding reduction in cash.
The Company accounts for its revenues pursuant to the provisions of ASC Topic 606, Revenue from Contracts with Customers (“ASC Topic 606”). The Company has no products approved for commercial sale and have not generated any revenue from commercial product sales. The revenue to date has been generated principally from out-licensing agreements with a small number of the Company's customers.
In determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation.
License Fees and Multiple Element Arrangements
If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, upfront fees allocated to the license at such time as the license is transferred to the licensee and the licensee is able to use, and benefit from, the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligations to determine whether the combined performance obligations are satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, upfront fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.
Appropriate methods of measuring progress include output methods and input methods. In determining the appropriate method for measuring progress, the Company considers the nature of service that the Company promises to transfer to the customer. When the Company decides on a method of measurement, the Company will apply that single method of measuring progress for each performance obligation satisfied over time and will apply that method consistently to similar performance obligations and in similar circumstances.
Customer Options
If an arrangement is determined to contain customer options that allow the customer to acquire additional goods or services, the goods and services underlying the customer options that are not determined to be material rights are not considered to be performance obligations at the outset of the arrangement, as they are contingent upon option exercise. The Company evaluate the customer options for material rights, or options to acquire additional goods or services for free or at a discount. If the customer options are determined to represent a material right, the material right is recognized as a separate performance obligation at the outset of the arrangement. The Company allocate the transaction price to material rights based on the relative standalone selling price, which is determined based on any identified discount and the probability that the customer will exercise the option. Amounts allocated to a material right are not recognized as revenue until, at the earliest, the option is exercised.
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. 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. The assessment of whether variable consideration should be constrained is largely a qualitative one that has two elements: the likelihood of a change in estimate, and the magnitude thereof. Variable consideration is not constrained if the potential reversal of cumulative revenue recognized is not significant, for example.
If the consideration in a contract includes a variable amount, the Company will estimate the amount of consideration in exchange for transfer of promised goods or services. The consideration also can vary if the Company’s entitlement to the consideration is contingent on the occurrence or non-occurrence of a future event. The Company considers contingent research milestone payments to fall under the scope of variable consideration, which should be estimated for revenue recognition purposes at the inception of the contract and reassessed ongoing at the end of each reporting period.
The Company assesses whether contingent research milestones should be considered variable consideration that should be constrained and thus not part of the transaction price. This includes an assessment of the probability that all or some of the milestone revenue could be reversed when the uncertainty around whether or not the achievement of each milestone is resolved, and the amount of reversal could be significant.
U.S. GAAP provides factors to consider when assessing whether variable consideration should be constrained. All of the factors should be considered, and no factor is determinate. The Company considers all relevant factors when assessing whether variable consideration should be constrained
Royalty Revenue
For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
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 may also include costs related to excess or obsolete inventory adjustment charges and amortization expense of intangible assets.
Research and Development Costs
Research and development (“R&D”) costs are expensed as incurred. R&D expenses consist of costs incurred in performing R&D activities, including salaries, share-based compensation and benefits, depreciation expense, third-party license fees, external costs of outside vendors engaged to conduct clinical development activities, clinical trials, costs to manufacture clinical trial materials and certain tax credits associated with research and development activities. Upfront and milestone payments to third parties for in-licensed products or technology which has not yet received regulatory approval and which does not have alternative future use in R&D projects or otherwise are expensed as incurred.
U.K. Research and Developments Tax Credits
As a company that carries out extensive R&D activities, the Company benefits from research and development tax credits in the U.K. The Company claims U.K. research and development tax credits under the regimes for small or medium-sized enterprises (“SME R&D tax credit”), and U.K. Research and Development Expenditure Credit (“RDEC”), to the extent that the Company's projects are grant funded.
The U.K. research and development tax credits are fully refundable to the Company and are not dependent on current or future taxable income. As a result, the Company records the entire benefit from the U.K. research and development tax credits as a benefit, which is included in net loss before income tax and accordingly, not reflected as part of the income tax provision. If, in the future, any U.K. research and development tax credits generated are needed to offset a corporate income tax liability in the U.K., that portion would be recorded as a benefit within the income tax provision and any refundable portion not dependent on taxable income would continue to be recorded as a reduction of research and development expenses.
Patent Costs
The Company expenses patent prosecution and related legal costs as they are incurred and classifies such costs as general and administrative expenses in the accompanying statements of operations and comprehensive loss.
Interest income arises on the Company's cash and cash equivalents including money market funds, short-term deposits and marketable securities classified as available for sale debt securities.
Share-Based Compensation
The Company recognizes share-based compensation expense for equity awards based on the grant date fair value of the award. The Company recognizes share-based compensation expense for awards granted to employees and non-employees that have a graded vesting schedule based on a service condition only on a straight-line basis over the requisite service period for each separately vesting portion of the award as if the award was, in substance, multiple awards (the “graded-vesting attribution method”), based on the estimated grant date fair value for each separately vesting tranche. For equity awards with a graded vesting schedule and a combination of service and performance conditions, the Company recognizes share-based compensation expense using a graded-vesting attribution method over the requisite service period when the achievement of a performance-based milestone is probable, based on the relative satisfaction of the performance condition as of the reporting date. For performance conditions related to regulatory approvals those regulatory approvals are deemed probable when actually achieved. The Company has elected to account for forfeitures of stock options when they occur by reversing share-based compensation expense previously recognized, in the period the award is forfeited, for an award that is forfeited before completion of the requisite service period.
The fair value of each share option grant is estimated on the date of grant using the Black-Scholes option pricing model. See Note 15,“Share-Based Compensation”, for the Company’s assumptions used in connection with share option grants made during the periods covered by these consolidated financial statements.
Assumptions used in the option pricing model include the following:
| •Expected volatility. | The Company historically lacked company-specific historical and implied volatility information for the Company's ADSs for expected terms greater than 6.08 years. Up to June 30, 2024, the Company used a combination of the historical volatility of the ADSs and also the expected share volatility based on the historical volatility of publicly traded peer companies. From July 1, 2024, the Company used its own historical regarding the volatility of its own traded ADS price. |
|---|---|
| •Expected term. | The expected term of the Company’s share options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. |
| •Risk-free interest rate. | The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods that are approximately equal to the expected term of the award. |
| •Expected dividend. | Expected dividend yield of zero is based on the fact that the Company has never paid cash dividends on ordinary shares and does not expect to pay any cash dividends in the foreseeable future. |
| •Fair value of ordinary shares. | The fair market value of the Company’s ADSs underlying the share option is equal to the closing price of the ADSs on the Nasdaq Global Select Market on the date the grant is approved by the Compensation Committee or a delegate of the Compensation Committee. |
Income Taxes
The Company accounts for income taxes under the asset and liability method which includes the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the Company’s financial statements. Under this approach, deferred taxes are recorded for the future tax consequences expected to occur when the reported amounts of assets and liabilities are recovered or paid. The provision for income taxes represents income taxes paid or payable for the current year plus deferred taxes. Deferred taxes result from differences between the financial statements and tax bases of the Company’s assets and liabilities and are adjusted for changes in tax rates and tax law when changes are enacted. The effects of future changes in income tax laws or rates are not anticipated.
The Company is subject to income taxes in the United Kingdom, the United States, Germany and Switzerland. The calculation of the Company’s tax provision involves the application of tax law in multiple jurisdictions and requires judgement and estimates.
The Company evaluates the realizability of its deferred tax assets at each reporting date, and establishes a valuation allowance when it is more likely than not that all or a portion of its deferred tax assets will not be realized.
The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income of the same character and in the same jurisdiction. The Company considers all available positive and negative evidence in making this assessment, including, but not limited to, the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies. In circumstances where there is sufficient negative evidence indicating that the Company’s deferred tax assets are not more likely than not realizable, the Company establishes a valuation allowance.
The Company uses a two-step approach for recognizing and measuring uncertain tax positions. The first step is to evaluate tax positions taken or expected to be taken in a tax return by assessing whether they are more likely than not sustainable, based solely on their technical merits, upon examination, and including resolution of any related appeals or litigation process. The second step is to measure the associated tax benefit or each position as the largest amount that the Company believes is more likely than not realizable. Differences between the amount of tax benefits taken or expected to be taken in the Company’s income tax returns and the amount of tax benefits recognized in its financial statements represent the Company’s unrecognized income tax benefits, which it either records as a liability or reduction of deferred tax assets.
Un-surrendered U.K. losses may be carried forward indefinitely to be offset against future taxable profits, subject to numerous utilization criteria and restrictions. The amount that can be offset each year is limited to £5.0 million plus an incremental 50% of United Kingdom taxable profits.
Comprehensive Loss
The Company follows the provisions of the Financial Accounting Standards Board (“FASB”) ASC Topic 220, Comprehensive Income, which establishes standards for the reporting and display of comprehensive income and its components. Comprehensive gain or loss is defined to include all changes in equity during a period except those resulting from investments by owners and distributions to owners.
Net Loss per Share
Basic and diluted net loss per ordinary share is determined by dividing net loss by the weighted average number of ordinary shares outstanding during the period. For all periods presented, the outstanding but unvested restricted shares, unvested restricted stock units (“RSU”), share options and warrants have been excluded from the calculation, due to their effects being anti-dilutive in nature. Therefore, the weighted average shares outstanding used to calculate both basic and diluted loss per share are the same for each period presented. Refer to Note 16, “Net Loss Per Share”.
Concentration of Credit Risk
Financial instruments that subject the Company to credit risk consist primarily of cash and cash equivalents, restricted cash and marketable securities: available-for-sale debt securities. The Company places cash and cash equivalents and restricted cash with established financial institutions with strong credit ratings. The Company holds significant amounts of cash and cash equivalents that are in excess of federally insured limits in various currencies, placed with one or more financial institutions for varying periods according to expected liquidity requirements. The Company's cash and cash equivalents are held with multiple banks and financial institutions. Management monitors the credit rating of those banks and financial institutions on a regular basis. The Company has no significant off-balance-sheet risk or concentration of credit risk, such as foreign exchange contracts, options contracts, or other foreign hedging arrangements.
Recently Issued Accounting Pronouncements
In January 2025, the FASB issued ASU 2025-01—Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date, to clarify the effective date of ASU No. 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. FASB clarified that all public business entities should initially adopt the disclosure requirements in the ASU 2024-04 in the first annual reporting period beginning after December 15, 2026, and interim reporting periods within annual reporting periods beginning after December 15, 2027. The Company is currently assessing the effect of this ASU on its consolidated financial statements and related disclosures.
In November 2024, the FASB issued ASU 2024-03—Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, to improve the disclosures about entity’s expenses. The amendments apply to all public business entities. The ASU is effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027 with early adoption permitted. The Company is currently assessing the effect of this ASU on its consolidated financial statements and related disclosures.
In March 2024, the FASB issued ASU 2024-02—Codification Improvements—Amendments to Remove References to the Concepts Statements, that contains amendments to the Codification that remove references to various FASB Concepts Statements. This effort facilitates Codification updates for technical corrections such as conforming amendments, clarifications to guidance, simplifications to wording or the structure of guidance, and other minor improvements. The amendments are effective for public business entities for fiscal years beginning after December 15, 2024, with early adoption permitted. Early application of the amendments in this ASU is permitted for all entities, for any fiscal year or interim period for which financial statements have not yet been issued (or made available for issuance). If an entity adopts the amendments in an interim period, it must adopt them as of the beginning of the fiscal year that includes that interim period. The Company is currently assessing the effect of this ASU on its consolidated financial statements and related disclosures.
In March 2024, the FASB issued ASU 2024-01—Compensation—Stock Compensation (Topic 718): Scope Application of Profits Interest and Similar Awards, to improve GAAP by adding an illustrative example that includes four fact patterns to demonstrate how an entity should apply the scope guidance in paragraph 718-10-15-3 to determine whether a profits interest award should be accounted for in accordance with Topic 718, Compensation—Stock Compensation. For public business entities, the amendments in this ASU are effective for annual periods beginning after December 15, 2024, and interim periods within those annual periods. Early adoption is permitted for both interim and annual financial statements that have not yet been issued or made available for issuance. If an entity adopts the amendments in an interim period, it should adopt them as of the beginning of the annual period that includes that interim period. The Company does not expect the adoption of ASU 2024-01 to have a material effect on its financial statements and related disclosures.
In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures. This ASU improves the transparency of income tax disclosure by requiring consistent categories and greater disaggregation of information in the rate reconciliation, and income taxes paid disaggregated by jurisdiction. This guidance is effective for the Company for the year beginning January 1, 2025, with early adoption permitted. The Company intends to adopt the guidance in the fiscal year beginning January 1, 2025. The Company does not expect the adoption of ASU 2023-09 to have a material effect on its financial statements and related disclosures.
In November 2023, the FASB issued Accounting Standards Update (ASU) 2023-07, Segment Reporting: Improvements to Reportable Segment Disclosures. This ASU modified the disclosure and presentation requirements primarily through enhanced disclosures of significant segment expenses and clarified that single reportable segment entities must apply Topic 280 in its entirety. The amendments should be applied retrospectively to all prior periods presented in the financial statement. The Company adopted the guidance in its Annual Report on Form 10-K for the year ended December 31, 2024 and additional disclosures have been included in Note 22.
Note 3. Revenue
Product revenue, net
On November 8, 2024 the Company was notified by the FDA that the Company’s BLA was approved, allowing for the marketing of AUCATZYL in the US for the treatment of adult patients with r/r B-ALL. The Company has not recognized product revenue during the year ended December 31, 2024.
License revenue
License revenue by geographical location for the years ended December 31, 2024 and 2023 comprised of the following (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| License revenue | ||
| United Kingdom | $— | $346 |
| United States | — | 1,352 |
| Europe | 10,120 | — |
| Total License revenue | $10,120 | $1,698 |
License and Option Agreement with BioNTech
See Note 1 for a description of the BioNTech License and Option Agreement, under which the Company recognized revenue during the year ended December 31, 2024. For further details on the terms and accounting treatment considerations for the BioNTech Agreement, refer to following notes to these consolidated financial statements:
Note 1, “Nature of the Business”
Note 2, “Summary of Significant Accounting Policies”
Note 12, “Liabilities Related to Future Royalties and Milestones, Net”
Note 14, “Shareholders’ Equity”
Note 20, “Commitments and Contingencies”
As the BioNTech License and Option Agreement has been accounted for asone freestanding financial instrument with various embedded features, including the Binder License and related transfer of know-how, Technology Options, and Product Options, the Company is required to consider if the embedded features are required to be bifurcated from the host contract and therefore accounted for as a separate derivative. The Company concluded the Binder License and related transfer of know-how, Technology Options, and Product Options meet the scope exception set out in ASC 815-10-15-59(d) and therefore not accounted for as derivatives under ASC 815.
Binder License
The Company applied ASC 606 to account for the Binder License and related know-how as functional intellectual property. The Binder License and related transfer of know-how were not distinct from one another and must be combined as a performance obligation, as BioNTech requires the know-how to derive benefit from the license. Based on these determinations, the Company identifiedone combined distinct performance obligation at the inception of the BioNTech License and Option Agreement.
The Company further determined the consideration received included in the transaction price at contract inception, is to be allocated to theone combined performance obligation. The Company determined that the performance obligation was recognized at a point-in-time, upon the delivery of the transfer of know-how and Binder License to BioNTech. The Company recognized total license revenue of $10.1 million (net of foreign exchange differences), related to the BioNTech License and Option Agreement during the year ended December 31, 2024.
The Company is eligible to receive milestone payments of up to $32.0 million in the aggregate upon the achievement of specified clinical development and regulatory milestones for each Binder Licensed Product that achieves such milestones. The Company is also eligible to receive a low single-digit royalty on net sales of Binder Licensed Products, subject to customary reductions, which are subject to specified limits. The royalty will be increased if BioNTech, its affiliates or sublicensees commercialize a Binder Licensed Product in an indication and country in which the Company or its affiliates or licensees also commercializes a product containing the same binders. Under the BioNTech License and Option Agreement, BioNTech is solely responsible for, and has sole decision-making authority with respect to, at its own expense, the exploitation of Binder Licensed Products. Milestone payments and royalty payments are regarded as variable consideration andwill be evaluated under the most likely amount method. Milestone payments and royalty payments were not included in the transaction price, as these amounts were fully constrained as of December 31, 2024.
Technology Options
The Company applied ASC 606, considering particularly the accounting guidance related to any options granted to customers to purchase additional goods or services at a future date as this could provide a material right to the customer. A material right is a promise embedded in a current contract that should be accounted for as a separate performance obligation. The Company determined the Technology Options were not offered at a significant and incremental discount. Accordingly, the Technology Options granted to BioNTech do not represent a material right and, therefore, were not a performance obligation at the outset of the arrangement. The Technology Option exercise fee equates to the standalone selling price of the technologies underlying each option and consequently, the transaction price of $10.0 million was not allocated to the Technology Options’ performance obligation. No Technology Options were exercised during the year ended December 31, 2024.
Product Options
As the Product Options are precluded from being accounted for under ASC 815 due to the scope exception, management considered the terms of the Product Options and concluded that they should be accounted for as a gain contingency under the scope of ASC 450- Contingencies(“ASC 450”). The Product Options, unlike the Technology Options, are 1) still subject to negotiation as to the specific activities to be performed by each party, which will be determined and agreed before the Product Options can be exercised, and 2) have not been exercised upon signature of the BioNTech License and Option Agreement. As a result, Product Options are not accounted for under to ASC 606, and no recognition is required under ASC 450, until the Product Options are exercised. No Product Options were exercised during the year ended December 31, 2024.
Research, Option and License Agreement with Cabaletta
On January 9, 2023, the Company entered into an Option and License Agreement (the “Cabaletta Agreement”) with Cabaletta Bio Inc. (“Cabaletta”), pursuant to which the Company granted to Cabaletta a non-exclusive license to research, develop, manufacture, have manufactured, use, and commercialize products incorporating the Company's safety switch technology (the “RQR8 technology”). Upon the execution of the Cabaletta Agreement, the Company made available the RQR8 licensed know-how to Cabaletta for a non-refundable license fee of $1.2 million. The Company has no further material performance obligations related to the Cabaletta Agreement.
The Company further granted to Cabaletta the option to expand the rights and licenses granted under the Cabaletta Agreement to include the research, development, manufacture, use, or commercialization of licensed products up to a predetermined number of target options upon payment of an option exercise fee.
The Company identified the following material promises relating to the granting of a non-exclusive license for research, development, manufacturing and commercialization activities as well as the initial transfer of know-how and information to Cabaletta. The Company determined the option exercise fee is not offered at a significant and incremental discount. Accordingly, the option granted to Cabaletta does not represent a material right and, therefore, is not a performance obligation at the outset of the arrangement. The Company determined that the granting of the research license and the initial transfer of know-how were not distinct from one another and must be combined as a performance obligation, as Cabaletta requires the know-how to derive benefit from the license. Based on these determinations, the Company identifiedone distinct performance obligation at the inception of the contract.
The Company further determined that the license fee payable constituted the entirety of the consideration included in the transaction price at contract inception, which was allocated to theone performance obligation. The amount of the transaction price allocated to the performance obligation is recognized as or when the Company satisfies the performance obligation. The Company determined that the performance obligation was recognized at a point-in-time, upon the delivery of the transfer of know-how and research license to Cabaletta. The Company recognized total license revenue of $1.2 million related to the Cabaletta Agreement for the year ended December 31, 2023. No license revenue was recognized related to the Cabaletta Agreement for the year ended December 31, 2024.
Upon execution of the Cabaletta Agreement, the transaction price included only the $1.2 million non-refundable license fee payable to the Company. The Company may receive further payments upon the exercise of the options for licensed targets, the achievement of certain development and sales milestones, as well as royalty payments based on net sales of each product covered by the licensed intellectual property.
The future milestones, which represent variable consideration, will be evaluated under the most likely amount method, and were not included in the transaction price, as these amounts were fully constrained asof December 31, 2024. For the year ended December 31, 2024 and 2023, the Company has not recognized any variable consideration with regards to the development milestones and sales-based milestones with its customers as they are deemed not probable.
For the years ended December 31, 2024 and 2023, the Company hasnot recognized any royalty revenue from the license agreements that were executed in the current and prior periods.
Note 4. Interest Expense, Net
Interest expense, net consisted of the following (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Interest expense accrued on liabilities related to future royalties and milestones, net (refer to Note 12) | $39,510 | $19,892 |
| Cumulative catch-up adjustment arising from the liabilities related to future royalties and milestones, net (refer to Note 12) | (30,644) | 25,107 |
| Other interest expense | 428 | 68 |
| $9,294 | $45,067 | |
Note 5. Fair value measurements
The following tables present information about the Company’s financial assets measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values (in thousands):
| December 31, 2024 | ||||
|---|---|---|---|---|
| Aggregate estimated fair value | Quoted Prices in Active Markets for Identical Assets (Level 1) | Significant Other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | |
| Assets classified as cash equivalents: | ||||
| Money market funds | $113,447 | $113,447 | $— | $— |
| Commercial paper | 14,301 | — | 14,301 | — |
| Debt Securities issued by Foreign Government | 54,897 | — | 54,897 | — |
| U.K. Government Gilts | 29,358 | — | 29,358 | — |
| US Treasury Bills | 7,989 | 7,989 | — | — |
| $219,992 | $121,436 | $98,556 | $— | |
| Assets classified as marketable securities: available-for-sale debt securities | ||||
| Commercial paper | $21,141 | $— | $21,141 | $— |
| Corporate debt securities | 151,124 | — | 151,124 | — |
| Debt Securities issued by Foreign Government | 72,012 | — | 72,012 | — |
| U.K. Government Gilts | 69,295 | — | 69,295 | — |
| US Treasury Bills | 47,071 | 47,071 | — | — |
| $360,643 | $47,071 | $313,572 | $— | |
| $580,635 | $168,507 | $412,128 | $— | |
| December 31, 2023 | ||||
|---|---|---|---|---|
| Total | Quoted Prices in Active Markets for Identical Assets (Level 1) | Significant Other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | |
| Assets classified as cash equivalents: | ||||
| Money market funds | $184,635 | $184,635 | $— | $— |
| $184,635 | $184,635 | $— | $— | |
The Company estimates the fair value of available-for-sale debt securities using actual trade and indicative prices sourced from third-party providers on a daily basis to estimate the fair value. If observed market prices are not available (for example securities with short maturities and infrequent secondary market trades), the securities are priced using a valuation model maximizing observable inputs, including market interest rates.
As of December 31, 2024 and 2023, the Company did not have non-financial assets measured at fair value on a recurring basis. During the years ended December 31, 2024 and 2023, there were no transfers between levels.
Note 6. Marketable Securities: Available-For-Sale Debt Securities
As of December 31, 2024, the Company has the following investments in available-for-sale debt securities, which are categorized as marketable securities: available-for-sale debt securities on the balance sheet depending on their maturity at acquisition (in thousands):
| Remaining contractual maturity | Amortized cost | Gross unrealized gains | Gross unrealized losses | Aggregate estimated fair value | |
|---|---|---|---|---|---|
| Marketable securities: available-for-sale debt securities: | |||||
| Commercial paper | within 1 year | $21,145 | $3 | $(7) | $21,141 |
| Corporate debt securities | within 1 year | 91,853 | 5 | (70) | 91,788 |
| Debt Securities issued by Foreign Government | within 1 year | 72,056 | — | (44) | 72,012 |
| U.K. Government Gilts | within 1 year | 69,320 | — | (25) | 69,295 |
| US Treasury Bills | within 1 year | 29,663 | 12 | — | 29,675 |
| Corporate debt securities | 1 to 5 years | 59,530 | — | (194) | 59,336 |
| US Treasury Bills | 1 to 5 years | 17,393 | 7 | (4) | 17,396 |
| Total | $360,960 | $27 | $(344) | $360,643 | |
There wereno available-for-sale debt securities as of December 31, 2023.
The number of securities held by the Company and aggregate fair value (in thousands) and in an unrealized loss position as of December 31, 2024 are as follows (in thousands):
| Number of securities held | Gross unrealized losses | Fair market value of investments in an unrealized loss position | |
|---|---|---|---|
| Marketable securities: available-for-sale debt securities in a continuous loss position for less than 12 months: | |||
| Commercial paper | 3 | $(6) | $8,944 |
| Corporate debt securities | 41 | (264) | 133,078 |
| Debt Securities issued by Foreign Government | 5 | (45) | 72,012 |
| U.K. Government Gilts | 3 | (25) | 69,295 |
| US Treasury Bills | 4 | (4) | 9,905 |
| Total | 63 | $(355) | $356,957 |
The aggregated net unrealized loss on available-for-sale debt securities in the amount of $0.3 million has been recognized in accumulated other comprehensive loss in the Company's consolidated balance sheet as of December 31, 2024.
At December 31, 2024, the Company held 63 marketable securities: available-for-sale debt securities out of its total investment portfolio that were in a continuous unrealized loss position. As of December 31, 2024, no allowance for expected credit losses has been recognized in relation to securities in an unrealized loss position. The related unrealized losses are not severe, have been for a short duration and are due to normal market, exchange rate fluctuations and all securities have an investment-grade credit rating. The Company neither intend to sell these investments nor conclude that the Company are more-likely-than-not that it will have to sell them before recovery of their carrying values. The Company also believe that it will be able to collect both principal and interest amounts due to the Company at maturity.
There were no amounts reclassified out of other comprehensive income (loss), net of tax during the year ended December 31, 2024.
Note 7. Inventories, Net
Inventories consisted of the following (in thousands):
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Raw materials | $1,956 | $— |
| Work in progress | 16 | — |
| Finished goods | 140 | — |
| Consumables | 2,026 | — |
| Total inventories, net | $4,138 | $— |
There wereno inventory write-downs recorded for the year ended December 31, 2024.
Note 8. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following (in thousands):
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Research and development claims receivable | $38,242 | $19,209 |
| Prepayments | 15,212 | 8,638 |
| VAT receivable | 5,996 | 2,771 |
| Accrued interest income | 2,566 | 999 |
| Deferred cost | 2,320 | 1,787 |
| Other assets | 1,571 | — |
| Lease and lease deposit receivable | 930 | 938 |
| Other receivable | 491 | 516 |
| Accounts receivable | 15 | 109 |
| Total prepaid expenses and other current assets | $67,343 | $34,967 |
Note 9. Property and Equipment, Net
Property and equipment, net consisted of the following (in thousands):
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Lab equipment | $41,728 | $32,232 |
| Office equipment | 6,330 | 3,777 |
| Furniture and fittings | 2,359 | 2,360 |
| Leasehold improvements | 14,116 | 12,728 |
| Assets under construction | 19,638 | 12,539 |
| Less: accumulated depreciation | (34,618) | (28,774) |
| Total property and equipment, net | $49,553 | $34,862 |
Depreciation expense recorded for the years ended December 31, 2024 and 2023 was $7.6 million and $6.6 million, respectively.
Note 10. Intangible Assets, Net
The following table summarizes the carrying amount of the Company's intangible assets, net of accumulated amortization (in thousands):
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Licensed IP rights | $12,535 | $— |
| Less: accumulated amortization | (162) | — |
| Total intangibles assets, net | $12,373 | $— |
Amortization expense was $0.2 million andnil for the year ended December 31, 2024 and 2023, respectively. The estimated aggregate amortization expense expected to be recorded in respect of this asset for each of the five years ended 2029 is $1.1 million annually.
Note 11. Accrued Expenses and Other Liabilities
Accrued expenses and other liabilities consisted of the following (in thousands):
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Compensation and benefits | $19,681 | $14,757 |
| Research and development costs | 13,372 | 19,825 |
| Professional fees | 9,075 | 4,466 |
| Other accrued expenditure | 6,075 | — |
| VAT payable | 3,594 | — |
| Other liabilities | 479 | 533 |
| Total accrued expenses and other liabilities | $52,276 | $39,581 |
Research and development costs have decreased primarily due to a reduction in clinical trials related costs relating to the Company's product candidate obe-cel.
Note 12. Liabilities Related to Future Royalties and Milestones, Net
The following table summarizes the carrying amount of the Company's liabilities related to future royalties and milestones, net (in thousands):
| Amount in thousands | |
|---|---|
| Balance at December 31, 2022 | $125,900 |
| Interest expense accrued on liabilities related to future royalties and milestones, net | 19,892 |
| Cumulative catch-up adjustment | 25,107 |
| Balance at December 31, 2023 | $170,899 |
| Initial recognition of BioNTech liability | 38,335 |
| Proceeds from Blackstone Development Payments received | 30,000 |
| Interest expense accrued on liabilities related to future royalties and milestones, net | 39,510 |
| Cumulative catch-up adjustment | (30,644) |
| Balance at December 31, 2024 | $248,100 |
The following table summarizes the current versus non-current split of the liabilities related to future royalties and milestones, net (in thousands):
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Current portion of liabilities related to future royalties and milestones, net | $3,500 | $— |
| Non-current portion of liabilities related to future royalties and milestones, net | 244,600 | 170,899 |
| Total liabilities related to future royalties and milestones, net | $248,100 | $170,899 |
Blackstone Agreements
On November 6, 2021, the Company concurrently entered into the following agreements with BXLS V - Autobahn L.P, (“Blackstone”) collectively called the “Blackstone Agreements”:
(i) Strategic Collaboration and Financing Agreement, (the “Blackstone Collaboration Agreement”);
(ii) Securities Purchase Agreement (the “Blackstone Securities Purchase Agreement”) - refer to Note 14. “Shareholders' Equity”;
(iii) Warrant Agreement (the “Blackstone Warrant”) - refer to Note 13, “Warrants"; and
(iv) a Registration Rights Agreement (the “Blackstone Registration Rights Agreement”).
The Blackstone Agreements were entered into and in contemplation of one another and, accordingly, the Company assessed the accounting for these agreements in the aggregate.
Blackstone Collaboration Agreement
Pursuant to the Blackstone Collaboration Agreement, Blackstone agreed to pay the Company up to $150 million to support the continued development of obe-cel, as well as next generation product therapies of obe-cel in B-cell malignancies. 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 November 2021, the upfront payment of $50 million was paid by Blackstone upon execution of the Blackstone Collaboration Agreement. In December 2022, two Blackstone Development Payments were paid by Blackstone of $35 million each as a result of (i) the joint steering committee’s review of Autolus’ interim analysis of pivotal FELIX Phase 2 clinical trial of obe-cel in relapsed/refractory (“r/r”) adult Acute Lymphoblastic Leukemia (“B-ALL”) and (ii) achievement of a pre-agreed manufacturing milestone as a result of completion of planned activities demonstrating the performance and qualification of the Company’s obe-cel’s manufacturing process. In December 2024, the remaining $30 million Blackstone Development Payment was paid to the Company on the approval of AUCATZYL by the FDA. The Company considers the achievement of the specified regulatory milestone as probable when actually achieved (i.e., when the contingency resolves).
In exchange for the Blackstone Development Payments, the Company 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”). The Company is also obligated to make payments (the “Sales Milestone Payments”), subject to the Aggregate Cap, if certain cumulative net sales levels are achieved.
The Company, and all of its subsidiaries have provided, and all of its future subsidiaries will provide, a guaranty to Blackstone of its obligations under the Blackstone Collaboration Agreement. In addition, the Company granted a security interest in its subsidiary Autolus Limited to Blackstone in certain intellectual property and financial assets of the Company and its subsidiaries. The security interest terminated in January 2025 upon the first commercial sale of AUCATZYL in the U.S. (such time, the “Release Time”).
The Blackstone Collaboration Agreement contains certain restrictive negative covenants that also expired upon the Release Time.
Termination of the Blackstone Collaboration Agreement by Blackstone due to certain breaches of the Blackstone Collaboration Agreement or other actions by the Company will require the Company to make liquidated damage payments to Blackstone in excess of the Blackstone Development Payments.
The Company has accounted for the Blackstone Collaboration Agreement as a liability primarily due to the Company's significant continuing involvement in generating the royalty stream. The Company will recognize the relevant portion of royalties or sales milestones due to Blackstone upon the commercialization of AUCATZYL or other products as a decrease to the applicable liabilities, with a corresponding reduction in cash.
On February 6, 2024, the Company concurrently entered into the BioNTech Agreements.
For further details on the terms and accounting treatment considerations for these contracts, refer to following notes to these interim condensed consolidated financial statements:
Note 1, “Nature of the Business”
Note 2, “Summary of Significant Accounting Policies”
Note 3, “Revenue”
Note 14, “Shareholders’ Equity”
Note 20, “Commitment and Contingencies”
Under the BioNTech License and Option Agreement, BioNTech has agreed to financially support the expansion of the clinical development program and planned commercialization of obe-cel. In exchange for the grant of rights to future revenues from the sales of obe-cel products, including AUCATZYL, BioNTech made an upfront payment to the Company of $40.0 million. The Company will pay BioNTech a low single-digit percentage of annual net sales of obe-cel products, which may be increased up to a mid-single digit percentage in exchange for milestone payments of up to $100.0 million in the aggregate on achievement of certain regulatory events for specific new indications upon BioNTech's election.
As the BioNTech License and Option Agreement has been accounted for asone freestanding financial instrument with various embedded features, (e.g. the Obe-cel Product Revenue Interest, milestone payments and royalties), the Company is required to consider if these embedded features are required to bifurcated from the host contract and therefore accounted for as a separate derivative. The Company determined the host contract to be debt-like and therefore the embedded features were analyzed pursuant to a debt host contract. The Company concluded the BioNTech License and Option Agreement (the host contract) should not be accounted as a derivative in accordance with ASC 815-10-15-59(d) but rather as a debt instrument under ASC 470.
The Company has accounted for the Obe-cel Product Revenue Interestas a liability primarily due to the Company’s significant continuing involvement in generating the royalty stream. In February 2024, the Company initially recognized the BioNTech Liability at $38.3 million being the face value less debt issuance costs. Once the Company commences commercial sales of AUCATZYL that generate royalties, which the Company expect will occur in the first quarter of 2025, the Company will recognize the portion of royalties paid to BioNTech as a decrease to the liability with a corresponding reduction in cash.
The carrying amount of the BioNTech Liability is based on the Company’s estimate of the future royalties to be paid to BioNTech to be received over the life of the arrangement as discounted using an effective interest rate. The excess or deficit of estimated present value of future royalties over the initial carrying amount, is recognized using the cumulative catch-up method within interest expense, net using the initial effective interest rate. The imputed rate of interest on the unamortized portion of the BioNTech Liability was approximately 28.70% as of February 6, 2024 and December 31, 2024,
Note 13. Warrants
On November 6, 2021, in connection with the Blackstone Agreement, pursuant to the Blackstone Warrant, the Company issued Blackstone a warrant to purchase up to 3,265,306 ADSs representing 3,265,306 of the Company's ordinary shares, at an exercise price of $7.35 per ADS. The Blackstone Warrant is exercisable in whole or in part until November 6, 2026.
The Blackstone Warrant mechanism does not create any obligation to transfer cash to the investor but a fixed amount of ordinary shares upon exercise. Therefore, the Company has accounted for the Blackstone Warrant as equity-classified instruments (recognized within additional paid-in capital), per ASC 815-40. The assessment considered whether the warrants were freestanding financial instruments, met the definition of a liability or whether the warrants met all of the requirements for equity classification, including whether the warrants were indexed to the Company’s own shares, among other conditions for equity classification.
The fair value of each Blackstone Warrant issued was estimated on the date of issuance using the Black-Scholes option pricing model. The assumptions used in the Black Scholes option pricing model relating to the Blackstone Warrant issued in 2021 included the following:
| •Expected volatility. | The Company lacks company-specific historical and implied volatility information for our ADSs for expected terms greater than 3.5 years. Therefore, the Company uses a combination of the historical volatility of its ADSs and also the expected share volatility based on the historical volatility of publicly traded peer companies and expect to continue to do so until such time as the Company has adequate historical data regarding the volatility of its own traded security price. |
|---|---|
| •Expected term. | The expected term of the Company’s warrants has been determined utilizing the contractual term of the warrants. |
| •Risk-free interest rate. | The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of granting of the warrant for time periods that are approximately equal to the expected term of the award. |
| •Expected dividend. | Expected dividend yield of zero is based on the fact that the Company has never paid cash dividends on ordinary shares and does not expect to pay any cash dividends in the foreseeable future. |
| •Fair value of ordinary shares. | The fair value of each ordinary share was based on the closing price of the Company's publicly traded ADSs as reported on date of issuance. |
The assumptions used in the Black-Scholes option pricing model to determine the fair value of the warrants issued to Blackstone as at November 6, 2021 were as follows:
| Expected warrant life (years) | 5 |
|---|---|
| Risk-free interest rate | 1.04% |
| Expected volatility | 80.23% |
| Expected dividend yield | 0% |
The Company determined the initial fair value of the Blackstone Warrant using the Black-Scholes option pricing model to be $10.7 million on November 6, 2021. As the Blackstone Warrant is classified as equity, it will not be remeasured at each reporting date.
Note 14. Shareholders’ Equity
Ordinary Shares
Each holder of ordinary shares is entitled to one vote per ordinary share and to receive dividends when and if such dividends are recommended by the Board of Directors (the "Board")and declared by the shareholders. As of December 31, 2024, the Company has not declared any dividends.
The Company has obtained shareholder approval to allot additional ordinary shares for a period offive years from June 2024 (being the date on which the Company's shareholders, at the Company's Annual General Meeting of Shareholders, approved an ordinary resolution containing the relevant authorization), up to a maximum nominal amount of $8,400, which authorization will need to be renewed upon expiration (i.e., at least every five years) but may be sought more frequently for additional five-year terms (or any shorter period).
As of December 31, 2024, the Company’s issued capital share consisted of (i)266,121,689 ordinary shares, with a nominal value of $0.000042 per share, (ii)34,425 deferred shares, with a nominal value of £0.00001 per share, (iii)88,893,548 B deferred shares, with a nominal value of £0.00099 per share and (iv)one C deferred share, with a nominal value of £0.000008. Each issued share has been fully paid.
Restricted Stock Units
At December 31, 2024, restricted stock unit awards for 3,648 ordinary shares had vested but the underlying shares had not been issued. However, these vested restricted stock unit awards have been included in the calculation of the Company’s outstanding shares at December 31, 2024 as they are considered issuable for little or no cash consideration. Subsequent to December 31, 2024, all of the underlying ordinary shares were issued.
Initial Public Offering ("IPO") and Impact of Corporate Reorganization
On June 18, 2018, Autolus Therapeutics Limited re-registered as a public limited company and its name was changed from Autolus Therapeutics Limited to Autolus Therapeutics plc.
On June 26, 2018, the Company closed its IPO. Upon the closing of the IPO, each separate class of ordinary shares of Autolus Therapeutics plc was converted into a single class of ordinary shares of Autolus Therapeutics plc as described further below.
Prior to the Company’s June 2018 reorganization and IPO, the Company had issued series A preferred shares, ordinary B shares, and ordinary C shares to fund its operations and upon the completion of the IPO, the different classes of shares were converted into a single class of ordinary shares on a 3.185-for-1 basis and created various classes of deferred shares.
The following deferred share classes were created:
Deferred Shares - The 34,425 deferred shares, aggregate nominal value less than $1.00, existed in Autolus Limited and were re-created in Autolus Therapeutics plc as part of the share exchange to place Autolus Therapeutics as the ultimate parent entity. The Company was required to replicate the shares to ensure the existing share has the correct nominal value to ensure stamp duty mirroring relief is available on the subsequent share for share exchange. These deferred shares have no voting rights.
Deferred B Shares - The deferred shares were the product of the reorganization of the series A preferred shares and ordinary B shares into ordinary shares. The nominal residual value was utilized by management as the required £50,000 of share capital to re-register Autolus Therapeutics Limited as Autolus Therapeutics plc. The resulting 88,893,548 deferred shares, aggregate nominal value of $118,000, is presented as a separate class of equity on the balance sheet and statement of shareholder’s equity. These deferred B shares have no voting rights.
Deferred C Share - The deferred share, nominal value less than $1.00, was created when the shares in the Company were redenominated from pounds sterling to U.S. Dollars as part of the capital reduction to deal with rounding issues that would otherwise have unbalanced the company’s nominal share capital. This deferred C share has no voting rights.
February 2024 Underwritten Offering
On February 12, 2024, the Company completed an underwritten offering of 58,333,336 ADSs representing 58,333,336 ordinary shares at an offering price of $6.00 per ADS. Aggregate net proceeds to the Company, after underwriting discounts and offering expenses, were$326.8 million.
BioNTech Securities Purchase Agreement
Concurrently with the execution of the BioNTech License and Option Agreement (see Note 1 and Note 3), the Company and BioNTech entered into the BioNTech Securities Purchase Agreement pursuant to which the Company sold ADSs, each representingone ordinary share, to BioNTech in a Private Placement transaction. On February 13, 2024, the Company completed the Private Placement of 33,333,333 ADSs representing 33,333,333 ordinary shares at an offering price of $6.00 per ADS. Aggregate net proceeds to the Company, after underwriting discounts and offering expenses, were$193.8 million.
In the event that BioNTech and the Company enter into the MCSA within 18 months of the initial closing of the Private Placement, BioNTech will purchase up to 15,000,000 ADSs for an aggregate purchase price of up to $20.0 million, subject to additional limitations and restrictions.
Note 15. Share-Based Compensation
In February 2017, the Board adopted the 2017 Share Option Plan, or the 2017 Plan. The 2017 Plan was set to expire on February 21, 2027. The 2017 Plan provided for the grant of potentially tax-favored Enterprise Management Incentives, or EMI, options to the Company's U.K. employees and for the grant of options to its U.S. employees.
In June 2018, the Company’s the Board and shareholders approved the 2018 Equity Incentive Plan, or the 2018 Plan. The initial maximum number of ordinary shares that may be issued under the 2018 Plan was 3,281,622. This number consists of 3,025,548 new ordinary shares and 256,074 ordinary shares that would have otherwise remained available for future grants under the 2017 Plan. The number of ordinary shares reserved for issuance under the 2018 Plan will automatically increase on October 1st of each year, for a period of not more thanten years, commencing on October 1, 2018 and ending on (and including) October 1, 2027, by an amount equal to the lesser of (i)4% of the total number of ordinary shares outstanding on September 30th of the same calendar year or (ii) such fewer number of ordinary shares as the board of directors may designate prior to the applicable October 1st date.
The updated maximum number of ordinary shares that may be issued under the 2018 Plan is 32,943,013 as of December 31, 2024. As of December 31, 2024,11,464,845 ordinary shares were available for future grant. The total shares issued under the 2018 Plan may be authorized but unissued shares, shares purchased on the open market, treasury shares or ADSs.
Share options granted under the 2018 Plan and 2017 Plan, as well as restricted shares granted as employee incentives, typically vest over afour-year service period with 25% of the award vesting on the first anniversary of the commencement date and the balance vesting monthly over the remaining three-years, unless the award contains specific performance vesting provisions.
Share options granted under the 2018 Plan and 2017 Plan generally expireten years from the date of grant. For certain senior members of management and directors, the Board has approved an alternative vesting schedule.
Share Option Valuation
The assumptions (see Note 2) used in the Black-Scholes option pricing model to determine the fair value of the share options granted to employees and directors during the years ended December 31, 2024 and 2023 were as follows:
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Expected option life (years) | 3.14 to 6.08 | 5.19 to 6.08 |
| Risk-free interest rate | 3.56% to 4.86% | 3.37% to 4.86% |
| Expected volatility | 79.48% to 83.87% | 83.25% to 85.51% |
| Expected dividend yield | 0% | 0% |
Share Options
The table below summarizes Company's share option activity during the year ended December 31, 2024.
| Number of Options | Weighted- Average Exercise Price per share | Weighted- Average Remaining Contractual Term (Years) | Aggregate Intrinsic Value (1)(in thousands) | |
|---|---|---|---|---|
| Outstanding as of December 31, 2023 | 17,956,385 | $5.64 | 8.35 | $48,968 |
| Granted | 4,283,550 | 4.09 | — | 62 |
| Exercised | (216,835) | 2.78 | — | 482 |
| Forfeited | (962,370) | 3.29 | — | 113 |
| Expired | (306,414) | 8.55 | — | 7 |
| Outstanding as of December 31, 2024 | 20,754,316 | $5.41 | 7.78 | $1,536 |
| Exercisable as of December 31, 2024 | 11,050,183 | $7.34 | 6.91 | $708 |
| Vested and expected to vest as of December 31, 2024 | 20,754,316 | $5.41 | 7.78 | $1,536 |
| (1) Aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair value of common stock for those options in the money as of December 31, 2024 | ||||
The total intrinsic value of options exercised was $0.5 million and $0.01 million, for the years ended December 31, 2024 and 2023, respectively. The aggregate intrinsic value of share options is calculated as the difference between the exercise price of the share options and the fair value of the Company’s underlying ordinary shares for those share options that had exercise prices lower than the fair value of the Company’s underlying ordinary shares. The total fair value of share options vested (including performance-based share options) amounted to $12.9 million and $11.4 million, for the years ended December 31, 2024 and 2023, respectively.
The weighted average grant-date fair value of share options granted was $2.96 and $1.69 per option for the years ended December 31, 2024 and 2023, respectively.
As of December 31, 2024, the total unrecognized compensation expense related to unvested share options without performance conditions was $11.4 million, which the Company expects to recognize over a weighted average vesting period of 2.98 years.
Performance based share options
The Company didnot grant share options with a specified regulatory performance condition during the year ended December 31, 2024,15,000 performance-based share options were forfeited or expired. In addition, during the year ended December 31, 2024,573,850 performance-based share options vested upon the achievement of the relevant regulatory milestone.
During the year ended December 31, 2023, the Company granted 107,600 share options with a specified regulatory performance condition. No performance-based share options were forfeited during the year ended December 31, 2023. In addition, during the year ended December 31, 2023,478,750 performance-based share options vested upon the achievement of the relevant regulatory milestone.
As of December 31, 2024 and 2023, all the performance condition related to these performance-based share options were met. As a result, $2.9 million and $1.0 million share-based compensation expense was recognized for the years ended December 31, 2024 and 2023, respectively.
Restricted Stock Units
An RSU award represents the right to receive one of the Company’s ADSs upon vesting of the RSU. The fair value of each RSU award is based on the closing price of the Company’s ADSs on the date of grant. In March 2021, the Company awarded RSU awards with service conditions that vest over afour-year service period with 25% on the first anniversary of the grant date, and the balance vesting quarterly over the remaining three-years.
In July 2023, the Company granted 90,000 RSU awards with a performance condition related to a specified regulatory milestone. These performance-based RSU awards have vested upon achievement of the related performance condition.
The following is a summary of the Company's RSU activity for the 2018 Plan for the year ended December 31, 2024:
| Number of restricted units | Weighted average grant date fair value | |
|---|---|---|
| Unvested and outstanding at December 31, 2023 | 116,436 | $3.43 |
| Vested | (82,848) | 3.08 |
| Forfeited | (1,176) | 6.20 |
| Unvested and outstanding at December 31, 2024 | 32,412 | $4.22 |
As of December 31, 2024, there was less than $0.1 million of unrecognized share-based compensation expense related to unvested RSUs without performance conditions, which are expected to be recognized over a weighted average period of 1.26 years.
The total fair value of share RSU awards vested (including performance-based RSU awards) amounted to $0.5 million and $1.3 million for the years ended December 31, 2024 and 2023, respectively.
Performance-based RSU awards
During the year ended December 31, 2024, the Company didnot grant RSU awards with performance conditions.
During the year ended December 31, 2023, the Company granted 90,000 RSU awards with performance condition related to a specified regulatory milestone. These performance-based RSU awards also vested during the year upon the achievement of the relevant regulatory milestone. This resulted in the recognition $0.2 million share-based compensation expense during the year ended December 31, 2023.
As of December 31, 2024 there wasno unrecognized share-based compensation expense relating to performance based RSU awards.
During the year ended December 31, 2024,3,648 RSU awards vested but were not issued as of December 31, 2024, and as such are not included in the Company's outstanding shares at December 31, 2024. The shares corresponding to these RSUs awards were issued in January 2025.
Share-based compensation expense
Share-based compensation expense recorded as research and development expenses, selling, general and administrative expenses and cost of sales is as follows (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Research and development expenses | $5,593 | $6,777 |
| Selling, general and administrative expenses | 9,622 | 4,473 |
| Cost of sales | 260 | — |
| Capitalized to intangible assets, net / property and equipment | (3) | (46) |
| Total share-based compensation expense | $15,472 | $11,204 |
Note 16. Net loss per share
Basic and diluted net loss per share attributable to ordinary shareholders was calculated as follows (in thousands, except share and per share amounts):
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Numerator | ||
| Net loss | $(220,662) | $(208,383) |
| Net loss attributable to ordinary shareholders - basic and diluted | $(220,662) | $(208,383) |
| Denominator | ||
| Weighted-average number of ordinary shares used in net loss per share - basic and diluted | 255,161,038 | 173,941,926 |
| Net loss per share - basic and diluted | $(0.86) | $(1.20) |
For all periods presented, outstanding but unvested RSUs, share options and warrants have been excluded from the calculation, because their effects would be anti-dilutive. Therefore, the weighted average number of ordinary shares used to calculate both basic and diluted loss per share are the same for all periods presented.
The following potentially dilutive securities have been excluded from the calculation of diluted net loss per share due to their anti-dilutive effect:
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Unvested RSUs | 32,412 | 116,436 |
| Share options | 20,754,316 | 17,956,385 |
| Warrants | 3,265,306 | 3,265,306 |
| Total | 24,052,034 | 21,338,127 |
Note 17. License Agreements
University College London Business Ltd. (UCLB) License
In September 2014, the Company entered into an exclusive license agreement (the “License”) with UCL Business Ltd. (“UCLB”), the technology transfer company of University College London (“UCL”), to obtain licenses to certain technology rights in the field of cancer therapy and diagnosis. In March 2016, the License was amended to include additional rights.
As part of the consideration for the License in September 2014, the Company issued 1,497,643 ordinary shares to UCLB. The Company paid upfront fees of £0.3 million and issued an additional 313,971 ordinary shares to UCLB when the License was amended in March 2016.
In March 2018, the License was further amended and restated to include a license to the Company's product candidate, obe-cel, for which UCL is conducting Phase 1 clinical trials in pediatric and adult ALL patients. The Company paid an upfront fee of £1.5 million for consideration for the amended and restated License and paid the additional £0.35 million in connection with UCLB's transfer of clinical data to the Company in December 2020. No equity was issued as part of the upfront fee consideration.
In October 2020, the License was further amended and restated to reflect the Company's election to have various patent rights assigned to the Company, and to include a license to new technology and further licenses to obe-cel for which UCL is conducting Phase 1 clinical trials in primary CNS Lymphoma patients.
Additionally, the Company may be obligated to make payments to UCLB under the amended and restated License upon the initiation of certain clinical activities in an aggregate amount of £0.18 million, the receipt of specified regulatory approvals in an aggregate amount of £37.5 million, the start of commercialization in an aggregate amount of £18.0 million, and the achievement of net sales levels in an aggregate amount of £51.0 million, as well as royalty payments based on possible future sales resulting from the utilization of the licensed technologies. On a per-product basis, these milestone payments range from £1.0 million to £18.5 million, depending on which T cell programming modules are used in the product achieving the milestone. On November 8, 2024 the Company was notified by the FDA that the Company’s BLA was approved, allowing for the marketing of AUCATZYL in the US for the treatment of adult patients (18 years and older) with r/r B-ALL. Consequently, the Company paid a regulatory milestone payment of £10.0 million to UCLB.
Under the terms of the license, the Company has the right to grant sub-licenses to third parties, subject to certain restrictions. If the Company receives any income in connection with such sublicenses, it must pay UCLB a percentage of the income allocable to the value of the sublicensed intellectual property rights ranging from the low twenties to mid-single digits percent, decreasing based on the development expenses incurred by the Company and the passage of time. During the year ended December 31, 2024, $0.1 million was payable to UCLB by the Company relating to the income allocable to the value of the sublicensed intellectual property rights. UCLB has retained the right to use the licensed T cell programming modules for academic research purposes at UCL and with other academic institutions, subject to certain restrictions.
Upon commercialization of any of the Company’s products that use the in-licensed patent rights, the Company will be obligated to pay UCLB a flat royalty for each licensed product ranging from the low- to mid-single digits, depending on which technologies are deployed in the licensed product, based on worldwide annual net sales of each licensed product, subject to certain reductions, including for the market entry of competing products and for loss of patent coverage of licensed products. The Company may deduct from the royalties payable to UCLB one-half of any payments made to a third party to obtain a license to such third party’s intellectual property that is necessary to exploit any licensed products. Once net sales of a licensed product have reached a certain specified threshold, the Company may exercise an option to buy out UCLB’s rights to the remaining milestone payments, royalty payments, and sublicensing revenue payments for such licensed product, on terms to be negotiated at the time.
The License expires on a product-by-product and country-by-country basis upon the expiration of the royalty term with respect to each product in each country. The Company may unilaterally terminate the license agreement for any reason upon advance notice to UCLB. Either party may terminate the License for the uncured material breach by the other party or for the insolvency of the other party. If UCLB terminates the License following the Company’s insolvency or the Company’s material breach of the License, or if the Company terminates the License unilaterally, all rights and licenses granted to the Company will terminate, and all patent rights and know-how transferred to the Company pursuant to the License will revert back to UCLB, unless and to the extent the Company has exercised its option to acquire ownership of the licensed patent rights. In addition, UCLB has the right to negotiate with the Company for the grant of an exclusive license to the Company’s improvements to the T cell programming modules the Company has licensed on terms to be agreed upon at the time.
Miltenyi Biotech B.V. & Co. KG
In September 2023, the Company entered into a non-exclusive sublicense agreement with Miltenyi Biotech B.V. & Co. KG (“Miltenyi”) under which the Company will have the right to develop, manufacture and use Miltenyi's or affiliates' sublicensed products. Under the agreement, the Company is obligated to make specified payments to Miltenyi upon the achievement of certain regulatory and clinical milestones. The Company recognized $0.4 million in aggregate relating to an upfront license payment and milestone payments that were deemed probable during the year ended December 31, 2023. There were no additional milestone payments deemed probable during the year ended December 31, 2024.
Note 18. Income Taxes
Loss before income tax benefit (expense) is as follows (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| U.K. | $(221,661) | $(209,766) |
| U.S. | 2,108 | 1,082 |
| Switzerland and Germany | 419 | 282 |
| Net loss before income taxes | $(219,134) | $(208,402) |
The components of income tax benefit (expense) are as follows (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| U.S. | ||
| Federal | $(1,228) | $(859) |
| State and local | (24) | (5) |
| U.K. | 8 | — |
| Switzerland and Germany | (459) | (104) |
| Total current tax expense | (1,703) | (968) |
| U.S. | ||
| Federal | (140) | 1,002 |
| State and local | 4 | (15) |
| U.K. | — | — |
| Switzerland and Germany | 311 | — |
| Total deferred tax benefit | 175 | 987 |
| Total income tax (expense) benefit | $(1,528) | $19 |
The Company recorded an income tax expense of $1.5 million and income tax benefit of less than $0.1 million, for the years ended December 31, 2024 and 2023, respectively.
Deferred tax assets consisted of the following at December 31, 2024 and 2023 (in thousands):
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Deferred tax assets: | ||
| Other differences | $18,761 | $14,834 |
| Tax losses | 136,406 | 104,534 |
| Fixed assets | 5,069 | 6,653 |
| Total deferred tax assets | 160,236 | 126,021 |
| Valuation allowances | (156,997) | (122,958) |
| Net deferred tax asset | $3,239 | $3,063 |
The movements in the deferred tax asset valuation allowance consisted of the following at December 31, 2024 and 2023 (in thousands):
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Valuation allowance as of January 1, | $(122,958) | $(95,955) |
| Decrease in valuation allowance through net loss | (36,670) | (21,245) |
| Foreign currency translation adjustments | 2,631 | (5,758) |
| Valuation allowance as of December 31, | $(156,997) | $(122,958) |
A reconciliation of income tax benefit at the U.K statutory corporate income tax rate to the income tax benefit is as follows (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Net loss before taxes | $(219,134) | $(208,402) |
| U.K. statutory tax rate | 25.0% | 23.5% |
| Income tax benefit at U.K. statutory tax rate | 54,783 | 48,974 |
| Tax-exempt reimbursable tax credits included within research and development expense | 4,934 | 4,589 |
| Non-deductible expenses | (26,810) | (31,268) |
| Adjustments in respect of prior years | 2,316 | (96) |
| Valuation allowance changes affecting the provision for income taxes | (36,670) | (21,245) |
| Other, net | (175) | (961) |
| Foreign rate differential | 94 | 26 |
| Total income tax (expense) benefit | $(1,528) | $19 |
| Current income tax expense | $(1,703) | $(968) |
| Deferred income tax benefit | $175 | $987 |
| Effective rate of income tax | 0.7% | —% |
The Company is headquartered and has subsidiaries in the United Kingdom. Additionally, the Company has subsidiaries in the United States, Germany and Switzerland. The Company incurs tax losses in the United Kingdom. The U.K. corporate income tax rate for the year ended December 31, 2024 was 25%, and was 23.5% for the years ended December 31, 2023. On April 1, 2023, the U.K government increased and enacted the corporate rate from 19% to 25%. The Company’s subsidiary in the United States has generated taxable profits due to a service agreement between the Company’s subsidiaries in the United States and the United Kingdom. The U.S. federal corporate income tax rate was 21% for the years ended December 31, 2024 and 2023.
Deferred tax assets resulting from loss carryforwards, fixed assets and retirement benefits, with total deferred tax assets increasing by $0.2 million in 2024. The Company has recorded a valuation allowance against the net deferred tax asset where the recoverability due to future taxable profits is unknown. The $3.2 million deferred tax asset balance is related to the Company's U.S. subsidiary entity.
At December 31, 2024, the Company had U.K. trading losses carryforward of $545.6 million. These losses are carried forward indefinitely under local law, but are subject to numerous utilization criteria and restrictions.
As required by the authoritative guidance on accounting for income taxes, the Company evaluates the realizability of deferred tax assets at each reporting date. Accounting for income taxes guidance requires that a valuation allowance be established when it is more likely than not that all or a portion of the deferred tax assets will not be realized. In circumstances where there is sufficient negative evidence indicating that the deferred tax assets are not more likely than not realizable, the Company establishes a valuation allowance.
The Company operates in multiple jurisdictions with complex tax and regulatory environment and its tax returns are periodically audited or subjected to review by tax authorities. The following table summarizes tax years that remain subject to examination by tax jurisdiction as of December 31, 2024:
| Jurisdiction | Open Tax Years Based on Originally Filed Returns |
|---|---|
| United Kingdom | 2022 - 2023 |
| United States | 2020 - 2023 |
Research and development U.K. tax credits
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 Small Medium Enterprise regime has been particularly beneficial to the Company, as under such program the trading losses that arise from the Company's 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. The U.K. 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 the Company do not receive income. A large proportion of costs in relation to the Company's pipeline research, clinical trials management and manufacturing development activities, all of which are being carried out by the Company's wholly owned 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.
During the year ended December 31, 2024, the Company met the conditions of the SME regime, but it could also make claims under the RDEC regime to the extent that its projects are grant funded.
In the accounting period to December 2023, based on the relevant tax legislation, the Company considered that it met the conditions of the R&D intensive scheme, and have made a claim on this basis. This is subject to agreement by the U.K. tax authority who, based on their non-statutory guidance, considers the basis for calculating whether a company meets the intensive criteria includes expenditure which is in conflict with the tax legislation. The position is uncertain and the legislation is currently untested in the U.K. courts. If the Company's claim is unsuccessful, normal SME relief will be available and there will be a material reduction in the value of the tax credit obtained (18.6% as opposed to 26.97% net benefit).
From January 2025, the Company does 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, the Company may make a claim under the merged RDEC regime beginning with periods ending December 31, 2025. It should be noted, however, that the types of qualifying expenditure in respect of which the Company 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).
R&D tax credits of $19.7 million and $19.5 million were recognized for the years ended December 31, 2024 and 2023, respectively, and are recorded as offsets to research and development expense in the Company's consolidated statement of operations and comprehensive loss.
Note 19. Leases
Operating Leases
Since September 2017, the Company has had an arrangement with Cell Therapy Catapult Limited to lease manufacturing suites at the Cell and Gene Therapy Catapult manufacturing center in Stevenage, United Kingdom. In March 2023, the Company and Cell Therapy Catapult Limited mutually agreed: (i) to terminate the lease relating to the leased manufacturing suite which originally had a lease term until February 2025, (ii) to extend the lease term ofone of the remaining manufacturing suites from June 2023 to August 2024, and (iii) to extend the lease term of a third manufacturing suite leased by the Company from September 2023 to August 2024. The Company recognized a lease termination loss of $0.1 million, which is included in other income, net on the consolidated statement of operations and comprehensive loss for the year ended December 31, 2023, related to the manufacturing suite terminated and exited on March 31, 2023. In addition, during the year ended December 31, 2023, the Company recognized a loss on disposal on leasehold improvements of $3.8 million arising from the manufacturing suite terminated and exited on March 31, 2023. In August 2024, one of the leased manufacturing suites ended and the Company exited the suite. In September 2024, the Company extended the lease term from August 2024 to December 2026 for the remaining manufacturing suite.
In February 2019, the Company agreed to enter into afifteen-year lease for manufacturing space units located in Enfield, United Kingdom, provided that the landlord completed the required leasehold improvements described in the agreement. The Company executed these lease agreements for 3 manufacturing space units, each forfifteen-year lease terms upon such completion. The leases commenced in February 2019, with the option to terminate the lease in February 2029. In addition to base rent, the Company is obligated to pay its proportionate share of building operating expenses and real estate taxes in excess of base year amounts. These costs are considered to be variable lease payments and are not included in the determination of the lease’s right-of-use asset or lease liability. In March 2021, one of the units was split in two separate units and the Company surrenderedone of those units back to the landlord. The Company has no further obligations for the surrendered unit and the right of use asset and lease liability which were recorded for this unit were written off during the year ended December 31, 2021. In October 2021, the Company subleasedtwo of thethree remaining units to third parties with lease terms ending in February 2029 and October 2026, respectively. Refer to “Sublease agreements” below for further details. The Company completed an asset impairment analysis of the right-of-use lease concluding the undiscounted cash flows exceeded the carrying value as of December 31, 2024 which resulted the recognition of a $0.4 million impairment of operating lease right-of-use assets and related property and equipment.
In September 2021, the Company also entered into a lease agreement for 2,762 square feet of laboratory and office space in Gaithersburg, Maryland, with a term until March 2024. In September 2023, the Company extended the original lease term to March 2027.
On September 19, 2023, the Company entered into a 20-year lease agreement with the landlord for The Nucleus. The Company made fit-out costs in other areas of the building which may be required to be removed at the end of the lease term. On September 10, 2024, the Company completed a variation of the lease for the manufacturing facility, related to additional works at the site. The landlord will provide funding for certain specified improvements to the facility (the “Works”), which the Company commits to undertake on a mutually agreed schedule. Funding received for the Works done are deemed lease incentives in accordance to ASC 842. Once the Works are complete, the rental payments under the lease will be increased according to a specified formula for the remainder of the lease term. The deed of variation does not affect the lease term, which continues to run for 20 years from September 19, 2023.
The following table shows the lease balance sheet classification of leases for the years ended December 31, 2024 and 2023 (in thousands):
| As of December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Assets | ||
| Operating lease right-of-use assets, net | $55,498 | $60,791 |
| Liabilities | ||
| Current | ||
| Operating lease liabilities, current | 2,998 | 5,053 |
| Non-current | ||
| Operating lease liabilities, non-current | 49,631 | 47,914 |
| Total lease liabilities | $52,629 | $52,967 |
The following table shows the lease costs for the years ended December 31, 2024 and 2023 (in thousands):
| Year ended December 31, | ||||
|---|---|---|---|---|
| Lease costs · Statement of Operations classification · 2024 · 2023 | ||||
| Operating lease costs | Operating expenses: research and development | $6,642 | $6,340 | |
| Variable costs | Operating expenses: research and development | 1,281 | 1,041 | |
| Short term lease costs | Operating expenses: research and development | 258 | 786 | |
| Operating lease costs | Operating expenses: general and administrative | 1,393 | 956 | |
| Variable costs | Operating expenses: general and administrative | 318 | 51 | |
| Short term lease costs | Operating expenses: general and administrative | 117 | 90 | |
| Operating lease costs | Operating expenses: cost of sales | 558 | — | |
| Variable costs | Operating expenses: cost of sales | 64 | — | |
| Total lease costs | $10,631 | $9,264 | ||
| Year ended December 31, | ||
|---|---|---|
| Other information | 2024 | 2023 |
| Cash paid for amounts included in the measurement of lease liabilities: | ||
| Operating cash outflows from operating leases (in thousands) | $4,258 | $10,407 |
| Weighted-average remaining lease term - operating leases (in years) | 15.9 years | 16.0 years |
| Weighted-average discount rate - operating leases | 8.15% | 7.44% |
Future fixed payments for non-cancellable operating leases in effect as of December 31, 2024 are payable as follows:
| Operating Leases | |
|---|---|
| Maturity of lease liabilities for the years ending December 31, | (in thousands) |
| 2025(1) | $(1,931) |
| 2026(1) | 8,049 |
| 2027 | 8,352 |
| 2028 | 7,637 |
| 2029 | 5,745 |
| Thereafter | 77,421 |
| Total lease payments | 105,273 |
| Less: imputed interest | (52,644) |
| Present value of lease liabilities | $52,629 |
| (1) Includes lease incentives from The Nucleus lease variation amounting to $10.2 million and $0.9 million, for the year ended December 31, 2025 and 2026, respectively. | |
Note 20. Commitments and Contingencies
Contractual obligations
In July 2022, the Company renegotiated a master services agreement (the “Adaptive Master Services Agreement”) with Adaptive Biotechnologies Corporation (“Adaptive”), under which Adaptive's assay is used to analyze patient samples from r/r B-ALL patients. During the year ended December 31, 2023, the Company recognized all contractual milestones relating to this contract. Under the then-current agreement, the Company would be obligated to make specified payments to Adaptive upon the achievement and receipt of certain regulatory approvals and achievement of commercial milestones in connection with the Company’s use of the Adaptive assay.
In previous periods, the Company has entered into agreements with certain advisory firms. The Company is obligated to make specified payments upon the achievement of certain strategic transactions involving the Company. During the year ended December 31, 2024, the Company paid a fee under these agreements.
The Company has estimated the probability of the Company achieving each potential milestone in relation to the agreements with UCLB, Miltenyi and its agreements with certain advisory firms in accordance with ASC 450. The Company considers the regulatory approval, commercial milestones and execution of collaboration agreements probable when actually achieved. Furthermore, the Company recognizes expenses for clinical milestones when their achievement is deemed probable. The Company concluded that, as of December 31, 2024, there were no other milestones or contingencies for which the likelihood of achievement was currently probable.
Capital Commitments
As of December 31, 2024, the Company’s unconditional purchase obligations for capital expenditure totaled $17.5 million and included signed orders for capital equipment and capital expenditure for construction and related expenditure relating primarily to its properties in the United Kingdom. The Company expects to incur the full amount of these obligations within one year.
Master Supply Commitments
In March 2018, the Company entered into a long-term supply agreement with Miltenyi Biotec GmbH, or Miltenyi, for the supply of Miltenyi’s CliniMACS Prodigy instruments, reagents and disposables for the manufacture of the Company's programmed T cell therapies for commercial, preclinical and clinical use as well as support services. The supply agreement sets forth procedures to ensure continuity of supply to the Company of Miltenyi’s products, both during the clinical phase and any future commercial phase of the Company's product candidates. After the initialten-year term of the agreement, the Company hastwo separate options to renew the agreement, each for an additional five-year term. The Company has a three-month firm commitment to purchase to reagents and disposables pursuant to the agreement.
As of December 31, 2024, the Company’s unconditional purchase obligations for reagents and disposables totaled $0.6 million, which the Company expects to incur within one year.
Distribution Commitments
The Company entered into an Exclusive Distribution Agreement, effective as of April 25, 2024 (the “Effective Date”), with Cardinal Health 105, LLC (“Cardinal Health”). Pursuant to, and subject to the terms and conditions of, the Exclusive Distribution Agreement, the Company engaged Cardinal Health as its exclusive third-party logistics distribution agent for sales of AUCATZYL in the US. The Exclusive Distribution Agreement runs for an initial term ofthree years following commercial launch and automatically renews for additional terms ofone year each, unless either party elects not to renew. Under the terms of the Exclusive Distribution Agreement, the Company must pay to Cardinal Health a one-time start-up fee, and a monthly account management fee upon the Company's commercial launch of AUCATZYL, and other fees for various services, including post-launch program implementation, information systems, warehouse operations and financial services.
BioNTech License and Option Agreement - Product Options gain contingency
As the Product Options within the BioNTech License and Option Agreement were an embedded feature within a freestanding financial instrument, the Company assessed if the Product Options should be accounted for as a derivative under ASC 815. However, the Company determined the Product Options met the scope exception for derivative accounting under ASC 815 and therefore should be accounted for a gain contingency under the scope of ASC 450. As of December 31, 2024, Product Options were not exercised and therefore no amounts were recognized.
Refer to Note 12, “Liabilities Related to Future Royalties and Milestone, Net” for further details about the BioNTech's Obe-cel Product Revenue Interest.
Legal Proceedings
From time to time, the Company may be a party to litigation or subject to claims incident to the ordinary course of business. Regardless of the outcome, litigation can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources and other factors. The Company was not a party to any litigation and did not have contingency reserves established for any liabilities as of December 31, 2024 and 2023.
Indemnification Agreements
In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnification. The Company’s exposure under these agreements is unknown because they involve claims that may be made against the Company in the future. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. However, the Company may record charges in the future as a result of these indemnification obligations.
In accordance with the indemnification agreements entered into with relevant individuals in accordance with the Company’s Articles of Association, the Company has indemnification obligations to its directors, officers and members of senior management for certain events or occurrences, subject to certain limits, while they are serving at the Company’s request in such capacity. There have been no claims to date under these indemnification agreements, and the Company has director and officer insurance that may enable it to recover a portion of any amounts paid for future potential claims.
SME R&D tax credit
In the accounting period to December 2023, based on the relevant tax legislation, the Company had met the conditions of the R&D intensive scheme, and therefore submitted its corporate tax return on this basis. This is subject to agreement by the U.K. tax authority who, based on their non-statutory guidance, considers the basis for calculating whether a company meets the intensive criteria includes expenditure which is in conflict with the tax legislation. The position is uncertain and the legislation is currently untested in the U.K. courts. If the Company's claim is unsuccessful, normal SME relief will be available and there will be a material reduction in the value of the tax credit obtained (18.6% as opposed to 26.97% net benefit). Should the uncertainty be resolved in the Company’s favor, this would result in a gain and accounted for a gain contingency under the scope of ASC 450.
Note 21. Employee Benefit Plans
In the United Kingdom, Germany and Switzerland, the Company makes contributions to defined contribution pension schemes on behalf of its employees. The Company expensed $2.7 million and $2.0 million in the years ended December 31, 2024 and 2023, respectively.
In the United States, the Company has established a defined contribution savings plan under Section 401(k) of the Internal Revenue Code. The plan covers substantially all U.S. employees who meet minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pre-tax basis. The Company matches employee contributions up tofour percent of the employee’s annual salary. The Company expensed $1.0 million and $0.4 million in contributions in the years ended December 31, 2024 and 2023, respectively. The Company pays all administrative fees related to the plan.
Note 22. Segment reporting
Long-lived assets
Long-lived assets (excluding intangibles, deferred tax and financial instruments) were located as follows (in thousands):
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| United Kingdom | $104,160 | $94,033 |
| United States of America | 891 | 1,620 |
| Total long-lived assets | $105,051 | $95,653 |
For the year ended December 31, 2024, the Company recognized an impairment of long-lived assets relating to the operating lease right-of-use assets and related property and equipment of $0.4 million related to a leased property in Enfield, United Kingdom. For the year ended December 31, 2023, the Company recognized an impairment loss on operating lease right-of-use assets and related property and equipment of $0.4 million related to a leased property in Stevenage, United Kingdom.
Revenue
Revenue recognized by geographic area are disclosed in Note 3,“Revenue”.
Major customers
During the year ended December 31, 2024,100% of the Company’s license revenues were generated from BioNTech. For the year ended December 31, 2023,76% and 20% of the Company's license revenues were primarily generated from Cabaletta and an investee of Syncona Portfolio Limited, respectively.
Segment profit or loss
The table below is a summary of the segment profit or loss, including significant segment expenses (in thousands):
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| License Revenue | $10,120 | $1,698 |
| Less operating expenses: | ||
| Research and clinical development | (37,831) | (50,585) |
| Product delivery | (89,815) | (60,290) |
| Commercial and Medical affairs | (55,219) | (14,955) |
| Support functions | (66,300) | (48,809) |
| Other segment expenses, net (1) | (2,381) | (6,760) |
| Total operating expenses | (251,546) | (181,399) |
| Operating loss | (241,426) | (179,701) |
| Other income, net | 220 | 222 |
| Foreign exchange (losses) gains | (989) | 2,639 |
| Interest income | 32,355 | 13,505 |
| Interest expense, net | (9,294) | (45,067) |
| Income tax (expense) benefit | (1,528) | 19 |
| Segment and consolidated net loss | $(220,662) | $(208,383) |
| (1) Other segment expenses, net include U.K. research and development tax credits, depreciation, amortization and share-based compensation expenses. | ||
Note 23. Related Party Transactions
Blackstone
On November 6, 2021, the Company concurrently entered into the Blackstone Agreements. Refer to Note 12, “Liabilities Related to Sales of Future Royalties and Milestones, Net”, Note 13, “Warrants” and Note 14, "Shareholders Equity”. Subsequent to the execution of the Blackstone Agreements, Blackstone became a related party as Blackstone owns more than 10% of the Company's outstanding voting securities and is therefore one of the principal owners of the Company. In addition, Blackstone received the right to nominateone director to the board of directors of the Company; William Young was appointed to the Company's board of directors as Blackstone’s designee pursuant to this right.
As of December 31, 2024, the carrying amount of the Blackstone Collaboration Agreement liability was $211.6 million, which included aggregated accrued interest expense and cumulative catch-up adjustment, of $10.7 million and $45.0 million for the years ended December 31, 2024 and 2023, respectively. Refer to Note 12,“Liabilities Related to Sales of Future Royalties and Milestones, Net” for further details.
In February 2024, the Company concurrently entered into the BioNTech Agreements. Upon the execution of the BioNTech Agreements, BioNTech became a related party of the Company. BioNTech owns more than 10% of the Company’s outstanding voting securities and is therefore one of the principal owners of the Company. In addition, BioNTech has the right to nominateone director to the Board of Directors of the Company which BioNTech has not yet exercised.
As of December 31, 2024, the carrying amount of the BioNTech Liability was $36.5 million which included aggregated accrued interest expense and cumulative catch-up adjustment of $(1.8) million for the year ended December 31, 2024. Refer to Note 12, “Liabilities Related to Sales of Future Royalties and Milestones, Net” for further details.
Investee of Syncona Portfolio Limited
The Company entered into a collaboration agreement in 2020 with an investee of Syncona Portfolio Limited, a holder of more than 10% of the Company's share capital. The terms of the agreement include a non-refundable license fee, payments based upon achievement of clinical development and regulatory objectives, and royalties on product sales. During the year ended December 31, 2023, the Company received variable consideration arising from the achievement of a development milestone amounting to $0.4 million. Consequently, the Company recognized license revenue of $0.4 million. The Company didnot recognize any license revenue for the year ended December 31, 2024.
2024 Underwritten Offering
In connection with our February 2024 underwritten offering, certain of our related parties purchased our ADSs from the underwriters at the public offering price of $6.00 per ADSs, and on the same terms as other investors in registered direct offering. The following table summarizes purchases of ADS by our related parties:
| Related party | ADSs purchased | Total purchase price (in millions) |
|---|---|---|
| Fidelity Management & Research Company, LLC (1) | 5,808,333 | $34.9 |
| Deep Track Capital, LP (2) | 3,750,000 | $30.0 |
(1) Fidelity Management & Research Company, LLC was a holder of more than 5% of our share capital as of December 31, 2024.
(2) Deep Track Capital, LP was a holder of more than 5% of our share capital as of December 31, 2024.
Note 24. Subsequent Events
The Company evaluated subsequent events through March 20, 2025, the date on which these consolidated financial statements were issued. The Company has concluded that no subsequent event has occurred that requires disclosure.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.