QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Not applicable | |||||||||||
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | ||||||||||
(Address of principal executive offices) | |||||||||||
(Registrant's telephone number, including area code) |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
* |
* | Not for trading, but only in connection with the listing of the American Depositary Shares on The Nasdaq Stock Market LLC. |
Large accelerated filer | ☐ | Accelerated filer | ☐ | ||||||||
☒ | Smaller reporting company | ||||||||||
Emerging growth company |
Item 1. Financial Information | |||||
Note | March 31, 2025 | December 31, 2024 | ||||||||||||||||||
Assets | ||||||||||||||||||||
Current assets: | ||||||||||||||||||||
Cash and cash equivalents | $ | $ | ||||||||||||||||||
Marketable securities - Available-for-sale debt securities | 7 | |||||||||||||||||||
Restricted cash | ||||||||||||||||||||
Accounts receivable, net | ||||||||||||||||||||
Inventories, net | 8 | |||||||||||||||||||
Prepaid expenses and other current assets | 9 | |||||||||||||||||||
Total current assets | ||||||||||||||||||||
Non-current assets: | ||||||||||||||||||||
Property and equipment, net | 10 | |||||||||||||||||||
Intangible assets, net | 11 | |||||||||||||||||||
Prepaid expenses and other non-current assets | ||||||||||||||||||||
Operating lease right-of-use assets, net | ||||||||||||||||||||
Long-term deposits | ||||||||||||||||||||
Deferred tax asset | ||||||||||||||||||||
Total assets | $ | $ | ||||||||||||||||||
Liabilities and shareholders’ equity | ||||||||||||||||||||
Current liabilities: | ||||||||||||||||||||
Accounts payable | $ | $ | ||||||||||||||||||
Accrued expenses and other liabilities | 12 | |||||||||||||||||||
Deferred revenue | ||||||||||||||||||||
Operating lease liabilities, current | ||||||||||||||||||||
Liabilities related to future royalties and milestones, net - current | 15 | |||||||||||||||||||
Total current liabilities | ||||||||||||||||||||
Non-current liabilities: | ||||||||||||||||||||
Operating lease liabilities, non-current | ||||||||||||||||||||
Liabilities related to future royalties and milestones, net - non-current | 15 | |||||||||||||||||||
Other long-term payables | ||||||||||||||||||||
Total liabilities | ||||||||||||||||||||
Commitments and contingencies | 17 | |||||||||||||||||||
Shareholders’ equity: | ||||||||||||||||||||
Ordinary shares, $ | ||||||||||||||||||||
Deferred shares, £ | ||||||||||||||||||||
Deferred B shares, £ | ||||||||||||||||||||
Deferred C shares, £ | ||||||||||||||||||||
Additional paid-in capital | ||||||||||||||||||||
Accumulated other comprehensive loss | ( | ( | ||||||||||||||||||
Accumulated deficit | ( | ( | ||||||||||||||||||
Total shareholders’ equity | ||||||||||||||||||||
Total liabilities and shareholders’ equity | $ | $ |
Three Months Ended March 31, | ||||||||||||||||||||
Note | 2025 | 2024 | ||||||||||||||||||
Revenue: | 3 | |||||||||||||||||||
Product revenue, net | $ | $ | ||||||||||||||||||
License revenue | ||||||||||||||||||||
Total revenue, net | ||||||||||||||||||||
Cost and operating expenses: | ||||||||||||||||||||
Cost of sales | ( | |||||||||||||||||||
Research and development expenses, net | ( | ( | ||||||||||||||||||
Selling, general and administrative expenses | ( | ( | ||||||||||||||||||
Loss on disposal of property and equipment | ( | |||||||||||||||||||
Loss from operations | ( | ( | ||||||||||||||||||
Other income (expense): | ||||||||||||||||||||
Other income (expenses), net | ( | |||||||||||||||||||
Foreign exchange gain (losses), net | ( | |||||||||||||||||||
Interest income | ||||||||||||||||||||
Interest expense | 4 | ( | ( | |||||||||||||||||
Total other expenses, net | ( | ( | ||||||||||||||||||
Net loss before income tax | ( | ( | ||||||||||||||||||
Income tax (expense) benefit | ( | |||||||||||||||||||
Net loss | ( | ( | ||||||||||||||||||
Other comprehensive income (loss): | ||||||||||||||||||||
Foreign currency exchange translation adjustment | ||||||||||||||||||||
Unrealized holding gains on available-for-sale debt securities, net of tax of $ | ||||||||||||||||||||
Total other comprehensive income, net of tax | ||||||||||||||||||||
Total comprehensive loss | $ | ( | $ | ( | ||||||||||||||||
Basic and diluted net loss per ordinary share | 5 | $ | ( | $ | ( | |||||||||||||||
Weighted-average basic and diluted ordinary shares | 5 |
Ordinary Shares | Deferred Shares | Deferred B Shares | Deferred C Shares | Additional Paid in Capital | Accumulated other comprehensive loss | Accumulated deficit | Total Shareholders' Equity | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at December 31, 2024 | $ | $ | $ | $ | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-based compensation expense | — | — | — | — | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Vesting of restricted stock unit awards net of shares withheld to cover tax withholding | — | — | — | — | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other comprehensive income | — | — | — | — | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | — | — | — | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at March 31, 2025 | $ | $ | $ | $ | $ | $ | ( | $ | ( | $ |
Ordinary Shares | Deferred Shares | Deferred B Shares | Deferred C Shares | Additional Paid in Capital | Accumulated other comprehensive loss | Accumulated deficit | Total Shareholders' Equity | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at December 31, 2023 | $ | $ | $ | $ | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Issuance of ordinary shares, net of issuance costs | — | — | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-based compensation expense | — | — | — | — | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Vesting of restricted stock unit awards net of shares withheld to cover tax withholding | — | — | — | — | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Exercise of share options | — | — | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other comprehensive income | — | — | — | — | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | — | — | — | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at March 31, 2024 | $ | $ | $ | $ | $ | $ | ( | $ | ( | $ |
Three Months Ended March 31, | |||||||||||
2025 | 2024 | ||||||||||
Cash flows from operating activities: | |||||||||||
Net loss | $ | ( | $ | ( | |||||||
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||
Depreciation on property and equipment | |||||||||||
Amortization of intangible assets | |||||||||||
Loss on disposal of property and equipment | |||||||||||
Share-based compensation net of amounts capitalized | |||||||||||
Interest expense accrued on liabilities related to future royalties and milestones, net | |||||||||||
Accretion of available-for-sale securities | ( | ||||||||||
Foreign exchange differences | ( | ||||||||||
Non-cash operating lease expense | |||||||||||
Deferred income tax | ( | ||||||||||
Changes in operating assets and liabilities: | |||||||||||
Decrease (increase) in prepaid expenses and other current assets | ( | ||||||||||
Decrease in prepaid expenses and other non-current assets | |||||||||||
Increase in inventories, net | ( | ||||||||||
Increase in accounts receivable, net | ( | ||||||||||
Increase in accounts payable | |||||||||||
Increase in deferred revenue | |||||||||||
Decrease in accrued expenses and other liabilities | ( | ( | |||||||||
Increase (decrease) in operating lease liability | ( | ||||||||||
Net cash used in operating activities | ( | ( | |||||||||
Cash flows from investing activities: | |||||||||||
Acquisition of property and equipment | ( | ( | |||||||||
Purchases of marketable securities: available-for-sale debt securities | ( | ||||||||||
Maturity / redemption of marketable securities: available-for-sale debt securities | |||||||||||
Net cash used in investing activities | ( | ( | |||||||||
Cash flows from financing activities: | |||||||||||
Proceeds of issuance of ordinary shares | |||||||||||
Payments of equity issuance costs | ( | ||||||||||
Proceeds from the exercise of share options | |||||||||||
Proceeds from liabilities related to future royalties and milestones, net | |||||||||||
Payments of issuance costs related to the liabilities related to future royalties and milestones, net | ( | ||||||||||
Net cash provided by financing activities | |||||||||||
Effect of exchange rate changes on cash, cash equivalents and restricted cash | ( | ||||||||||
Net (decrease) increase in cash, cash equivalents and restricted cash | ( | ||||||||||
Cash, cash equivalents and restricted cash, beginning of period | |||||||||||
Cash, cash equivalents and restricted cash, end of period | $ | $ | |||||||||
Three Months Ended March 31, | |||||||||||
2025 | 2024 | ||||||||||
Unaudited supplemental cash flow information | |||||||||||
Cash paid for income taxes | $ | $ | |||||||||
Unaudited supplemental non-cash flow information | |||||||||||
Property and equipment purchases included in accounts payable or accrued expenses | $ | $ | |||||||||
Leased assets obtained in exchange for operating lease liabilities | $ | $ | |||||||||
Capitalized share-based compensation, net of forfeitures | $ | $ | |||||||||
Capitalized implementation costs included in accrued expenses | $ | $ | |||||||||
Equity issuance costs included in accounts payable and accrued expenses | $ | $ | |||||||||
Liability issuance costs included in accounts payable and accrued expenses | $ | $ | |||||||||
Reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets: | |||||||||||
Cash and cash equivalents | $ | $ | |||||||||
Restricted cash | |||||||||||
Total cash, cash equivalents and restricted cash | $ | $ |
Three Months Ended March 31, | ||||||||||||||
2025 | 2024 | |||||||||||||
Product revenue, net | ||||||||||||||
United States of America | $ | $ | ||||||||||||
Total Product revenue, net | $ | $ |
Rebates | Chargebacks | Total | ||||||||||||||||||
As of December 31, 2024 | $ | $ | $ | |||||||||||||||||
Provisions relates to sales in the period | ||||||||||||||||||||
Credits and payments made | ( | ( | ||||||||||||||||||
As of March 31, 2025 | $ | $ | $ |
Three Months Ended March 31, | ||||||||||||||
2025 | 2024 | |||||||||||||
License revenue | ||||||||||||||
Europe | $ | $ | ||||||||||||
Total License revenue | $ | $ |
Three Months Ended March 31, | ||||||||||||||
2025 | 2024 | |||||||||||||
Interest expense accrued on liabilities related to future royalties and milestones, net | $ | $ | ||||||||||||
Cumulative catch-up adjustment arising from the liabilities related to future royalties and milestones, net | ||||||||||||||
Other interest expense | ||||||||||||||
Total interest expense | $ | $ |
Three Months Ended March 31, | |||||||||||
2025 | 2024 | ||||||||||
Numerator | |||||||||||
Net loss | $ | ( | $ | ( | |||||||
Net loss - basic and diluted | $ | ( | $ | ( | |||||||
Denominator | |||||||||||
Weighted-average number of ordinary shares used in net loss per share - basic and diluted | |||||||||||
Basic and diluted net loss per ordinary share | $ | ( | $ | ( |
Three Months Ended March 31, | |||||||||||
2025 | 2024 | ||||||||||
Unvested restricted stock units | |||||||||||
Share options | |||||||||||
Warrants | |||||||||||
Total potentially dilutive securities |
March 31, 2025 | |||||||||||||||||||||||
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 | $ | $ | $ | $ | |||||||||||||||||||
Debt Securities issued by Foreign Government | |||||||||||||||||||||||
$ | $ | $ | $ | ||||||||||||||||||||
Assets classified as marketable securities: available-for-sale debt securities | |||||||||||||||||||||||
Commercial paper | $ | $ | $ | $ | |||||||||||||||||||
Corporate debt securities | |||||||||||||||||||||||
Debt Securities issued by Foreign Government | |||||||||||||||||||||||
United Kingdom Government Gilts | |||||||||||||||||||||||
United States Treasury Bills | |||||||||||||||||||||||
$ | $ | $ | $ | ||||||||||||||||||||
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 | $ | $ | $ | $ | |||||||||||||||||||
Commercial paper | |||||||||||||||||||||||
Debt Securities issued by Foreign Government | |||||||||||||||||||||||
United Kingdom Government Gilts | |||||||||||||||||||||||
United States Treasury Bills | |||||||||||||||||||||||
$ | $ | $ | $ | ||||||||||||||||||||
Assets classified as marketable securities: available-for-sale debt securities | |||||||||||||||||||||||
Commercial paper | $ | $ | $ | $ | |||||||||||||||||||
Corporate debt securities | |||||||||||||||||||||||
Debt Securities issued by Foreign Government | |||||||||||||||||||||||
United Kingdom Government Gilts | |||||||||||||||||||||||
United States Treasury Bills | |||||||||||||||||||||||
$ | $ | $ | $ | ||||||||||||||||||||
March 31, 2025 | ||||||||||||||||||||||||||||||||
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 | $ | $ | $ | ( | $ | ||||||||||||||||||||||||||
Corporate debt securities | within 1 year | ( | ||||||||||||||||||||||||||||||
Debt Securities issued by Foreign Government | within 1 year | ( | ||||||||||||||||||||||||||||||
United Kingdom Government Gilts | within 1 year | |||||||||||||||||||||||||||||||
United States Treasury Bills | within 1 year | ( | ||||||||||||||||||||||||||||||
Corporate debt securities | 1 to 5 years | ( | ||||||||||||||||||||||||||||||
United States Treasury Bills | 1 to 5 years | |||||||||||||||||||||||||||||||
Total | $ | $ | $ | ( | $ |
December 31, 2024 | ||||||||||||||||||||||||||||||||
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 | $ | $ | $ | ( | $ | ||||||||||||||||||||||||||
Corporate debt securities | within 1 year | ( | ||||||||||||||||||||||||||||||
Debt Securities issued by Foreign Government | within 1 year | ( | ||||||||||||||||||||||||||||||
United Kingdom Government Gilts | within 1 year | ( | ||||||||||||||||||||||||||||||
United States Treasury Bills | within 1 year | |||||||||||||||||||||||||||||||
Corporate debt securities | 1 to 5 years | ( | ||||||||||||||||||||||||||||||
United States Treasury Bills | 1 to 5 years | ( | ||||||||||||||||||||||||||||||
Total | $ | $ | $ | ( | $ |
March 31, 2025 | ||||||||||||||||||||
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 | $ | ( | $ | |||||||||||||||||
Corporate debt securities | ( | |||||||||||||||||||
Debt Securities issued by Foreign Government | ( | |||||||||||||||||||
United States Treasury Bills | ( | |||||||||||||||||||
Total | $ | ( | $ |
December 31, 2024 | ||||||||||||||||||||
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 | $ | ( | $ | |||||||||||||||||
Corporate debt securities | ( | |||||||||||||||||||
Debt Securities issued by Foreign Government | ( | |||||||||||||||||||
United Kingdom Government Gilts | ( | |||||||||||||||||||
United States Treasury Bills | ( | |||||||||||||||||||
Total | $ | ( | $ |
March 31, | December 31, | |||||||||||||
2025 | 2024 | |||||||||||||
Consumables | $ | $ | ||||||||||||
Raw materials | ||||||||||||||
Work in progress | ||||||||||||||
Finished goods | ||||||||||||||
Total inventories, net | $ | $ |
March 31, | December 31, | ||||||||||
2025 | 2024 | ||||||||||
Research and development claims receivable | $ | $ | |||||||||
Prepayments | |||||||||||
VAT receivable | |||||||||||
Deferred cost | |||||||||||
Accrued interest income | |||||||||||
Other assets | |||||||||||
Lease and lease deposit receivable | |||||||||||
Other receivables | |||||||||||
Total prepaid expenses and other current assets | $ | $ |
March 31, | December 31, | ||||||||||
2025 | 2024 | ||||||||||
Lab equipment | $ | $ | |||||||||
Office equipment | |||||||||||
Furniture and fixtures | |||||||||||
Leasehold improvements | |||||||||||
Assets under construction | |||||||||||
Less: accumulated depreciation | ( | ( | |||||||||
Total property and equipment, net | $ | $ |
March 31, | December 31, | |||||||||||||
2025 | 2024 | |||||||||||||
Licensed IP rights | $ | $ | ||||||||||||
Software licenses | ||||||||||||||
Less: accumulated amortization | ( | ( | ||||||||||||
Total intangibles assets, net | $ | $ |
March 31, | December 31, | ||||||||||
2025 | 2024 | ||||||||||
Compensation and benefits | $ | $ | |||||||||
Research and development costs | |||||||||||
Other accrued expenditure | |||||||||||
Professional fees | |||||||||||
VAT accrual | |||||||||||
Other liabilities | |||||||||||
Rebates, chargebacks and returns | |||||||||||
Total accrued expenses and other liabilities | $ | $ |
Three Months Ended March 31, | |||||||||||
2025 | 2024 | ||||||||||
Research and development expenses | $ | $ | |||||||||
Selling, general and administrative expenses | |||||||||||
Cost of sales | |||||||||||
Capitalized to intangibles, net / property and equipment, net | ( | ( | |||||||||
Total share-based compensation expense | $ | $ |
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, 2024 | $ | $ | ||||||||||||||||||||||||
Granted | ||||||||||||||||||||||||||
Forfeited | ( | |||||||||||||||||||||||||
Expired | ( | |||||||||||||||||||||||||
Outstanding as of March 31, 2025 | $ | $ | ||||||||||||||||||||||||
Exercisable as of March 31, 2025 | $ | $ | ||||||||||||||||||||||||
Vested and expected to vest as of March 31, 2025 | $ | $ | ||||||||||||||||||||||||
(1) Aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair value of ordinary shares for those options in the money as of March 31, 2025. |
Number of restricted units | Weighted average grant date fair value | |||||||||||||
Unvested and outstanding at December 31, 2024 | $ | |||||||||||||
Vested | ( | |||||||||||||
Forfeited | ( | |||||||||||||
Unvested and outstanding at March 31, 2025 | $ |
March 31, | December 31, | ||||||||||
2025 | 2024 | ||||||||||
Balance at January 1 | $ | $ | |||||||||
Initial recognition of BioNTech liability | |||||||||||
Proceeds from Blackstone Development Payments received | |||||||||||
Interest expense accrued on liabilities related to future royalties and milestones, net | |||||||||||
Cumulative catch-up adjustment | ( | ||||||||||
Total liabilities related to future royalties and milestones, net | $ | $ |
March 31, | December 31, | ||||||||||
2025 | 2024 | ||||||||||
Current portion of liabilities related to future royalties and milestones, net | $ | $ | |||||||||
Non-current portion of liabilities related to future royalties and milestones, net | |||||||||||
Total liabilities related to future royalties and milestones, net | $ | $ |
Three Months Ended March 31, | ||||||||||||||
2025 | 2024 | |||||||||||||
Operating lease costs | $ | $ | ||||||||||||
Variable costs | ||||||||||||||
Short term lease costs | ||||||||||||||
Total lease costs | $ | $ | ||||||||||||
Three Months Ended March 31, | ||||||||||||||||||||
Other information | 2025 | 2024 | ||||||||||||||||||
Cash paid for amounts included in the measurement of lease liabilities: | ||||||||||||||||||||
Operating cash (inflows) outflows from operating leases(1) | $ | ( | $ | |||||||||||||||||
(1) Includes lease incentives received during the three months ended March 31, 2025 relating to our Nucleus facility lease. | ||||||||||||||||||||
Three Months Ended March 31, | ||||||||||||||||||||
2025 | 2024 | |||||||||||||||||||
Weighted-average remaining lease term - operating leases | ||||||||||||||||||||
Weighted-average discount rate - operating leases | % | % |
2025(1) | $ | |||||||||||||
2026(1) | ||||||||||||||
2027 | ||||||||||||||
2028 | ||||||||||||||
2029 | ||||||||||||||
Thereafter | ||||||||||||||
Total lease payments | ||||||||||||||
Less: imputed interest | ( | |||||||||||||
Present value of lease liabilities | $ | |||||||||||||
(1) Includes lease incentives from the Nucleus facility lease variation amounting to $ |
March 31, | December 31, | |||||||||||||||||||
2025 | 2024 | |||||||||||||||||||
United Kingdom | $ | $ | ||||||||||||||||||
United States of America | ||||||||||||||||||||
Total long-lived assets | $ | $ |
March 31, | March 31, | ||||||||||
2025 | 2024 | ||||||||||
Product Revenue, net | $ | $ | |||||||||
License Revenue | |||||||||||
Less operating expenses: | |||||||||||
Research and clinical development | ( | ( | |||||||||
Product delivery | ( | ( | |||||||||
Commercial and Medical affairs | ( | ( | |||||||||
Support functions | ( | ( | |||||||||
Other segment expenses, net (1) | ( | ( | |||||||||
Total operating expenses | ( | ( | |||||||||
Operating loss | ( | ( | |||||||||
Other income, net | ( | ||||||||||
Foreign exchange (losses) gains | ( | ||||||||||
Interest income | |||||||||||
Interest expense, net | ( | ( | |||||||||
Income tax (expense) benefit | ( | ||||||||||
Segment and consolidated net loss | $ | ( | $ | ( | |||||||
(1) Other segment expenses, net include United Kingdom research and development tax credits, depreciation, amortization and share-based compensation expenses. |
Three Months Ended March 31, | Change | Change | |||||||||||||||||||||
2025 | 2024 | (in thousands) | (in percentage) | ||||||||||||||||||||
Revenue: | |||||||||||||||||||||||
Product revenue, net | $ | 8,982 | $ | — | $ | 8,982 | 100 | % | |||||||||||||||
License revenue | — | 10,091 | (10,091) | (100) | % | ||||||||||||||||||
Total revenue, net | 8,982 | 10,091 | (1,109) | (11) | % | ||||||||||||||||||
Cost and operating expenses: | |||||||||||||||||||||||
Cost of sales | (17,951) | — | (17,951) | 100 | % | ||||||||||||||||||
Research and development expenses, net | (26,734) | (30,671) | 3,937 | (13) | % | ||||||||||||||||||
Selling, general and administrative expenses | (29,534) | (18,177) | (11,357) | 62 | % | ||||||||||||||||||
Loss on disposal of property and equipment | (3) | — | (3) | 100 | % | ||||||||||||||||||
Loss from operations | (65,240) | (38,757) | (26,483) | 68 | % | ||||||||||||||||||
Other income (expense): | |||||||||||||||||||||||
Other income (expenses), net | 129 | (300) | 429 | (143) | % | ||||||||||||||||||
Foreign exchange gains (losses), net | 1,181 | (1,305) | 2,486 | (190) | % | ||||||||||||||||||
Interest income | 6,137 | 6,933 | (796) | (11) | % | ||||||||||||||||||
Interest expense, net | (10,143) | (19,269) | 9,126 | (47) | % | ||||||||||||||||||
Total other income (expense), net | (2,696) | (13,941) | 11,245 | (81) | % | ||||||||||||||||||
Net loss before income tax | (67,936) | (52,698) | (15,238) | 29 | % | ||||||||||||||||||
Income tax (expense) benefit | (2,225) | 8 | (2,233) | (27913) | % | ||||||||||||||||||
Net loss | $ | (70,161) | $ | (52,690) | $ | (17,471) | 33 | % |
Three Months Ended March 31, | Change (in thousands) | Change (in percentage) | |||||||||||||||||||||
2025 | 2024 | ||||||||||||||||||||||
Direct research and development expenses | |||||||||||||||||||||||
B cell malignancies (Obe-cel & AUTO1/22) | $ | 10,643 | $ | 4,309 | $ | 6,334 | 147 | % | |||||||||||||||
Other projects (AUTO4, AUTO5, AUTO6, AUTO7 & AUTO8) | 168 | 168 | — | — | % | ||||||||||||||||||
Total direct research and development expense | $ | 10,811 | $ | 4,477 | $ | 6,334 | 141 | % | |||||||||||||||
Indirect research and development expenses and unallocated costs: | |||||||||||||||||||||||
Personnel related (including share-based compensation) | $ | 13,396 | $ | 15,403 | (2,007) | (13) | % | ||||||||||||||||
Indirect research and development expense* | 2,527 | 10,791 | (8,264) | (77) | % | ||||||||||||||||||
Total research and development expenses | $ | 26,734 | $ | 30,671 | $ | (3,937) | (13) | % | |||||||||||||||
* Indirect research and development expense is net of United Kingdom research and development tax credits |
Three Months Ended March 31, | |||||||||||
2025 | 2024 | ||||||||||
Net cash used in operating activities | $ | (75,565) | $ | (40,514) | |||||||
Net cash used in investing activities | (59,547) | (533) | |||||||||
Net cash provided by financing activities | — | 561,441 | |||||||||
Effect of exchange rate changes on cash, cash equivalents and restricted cash | 3,558 | (1,185) | |||||||||
Net (decrease) increase in cash, cash equivalents and restricted cash | $ | (131,554) | $ | 519,209 |
Exhibit number | Description | |||||||||||||||||||||||||||||||
101.INS* | Inline XBRL Instance Document | |||||||||||||||||||||||||||||||
101.SCH* | Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents | |||||||||||||||||||||||||||||||
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
+ | Indicates management contract or compensatory plan. | ||||
† | Certain portions of the exhibit (indicated by asterisks) have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K. The registrant hereby undertakes to furnish supplementally a copy of any omitted exhibit or schedule upon request by the SEC. | ||||
# | Certain exhibits and schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The registrant hereby undertakes to furnish supplementally a copy of any omitted exhibit or schedule upon request by the SEC. | ||||
* | Filed herewith | ||||
** | This certification is being furnished solely to accompany this Quarterly Report on Form 10-Q pursuant to 18 U.S.C. Section 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing of the registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date hereof, regardless of any general incorporation language in such filing. | ||||
Autolus Therapeutics plc | ||||||||||||||
Date: | May 8, 2025 | By: | /s/ Christian Itin, Ph.D. | |||||||||||
Name | Christian Itin, Ph.D. | |||||||||||||
Title: | Chief Executive Officer | |||||||||||||
(On Behalf of the Registrant and as Principal Executive Officer) | ||||||||||||||
Date: | May 8, 2025 | By: | /s/ Robert Dolski | |||||||||||
Name | Robert Dolski | |||||||||||||
Title: | Chief Financial Officer | |||||||||||||
(Principal Financial Officer and Principal Accounting Officer) |
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Optionholder: | |||||
Date of Grant: | |||||
Vesting Commencement Date: | |||||
Number of Shares Subject to Option: | |||||
Exercise Price (Per Share) (US$): | |||||
Total Exercise Price (US$): | |||||
Expiration Date: |
Autolus Therapeutics plc By: Signature Title: Date: | Optionholder: Signature Date: |
Participant: | |||||
Date of Grant: | |||||
Vesting Commencement Date: | |||||
Number of Restricted Share Units/Shares: |
Vesting Schedule: | Subject to Participant’s Continuous Service through each applicable vesting date, the RSUs shall vest as follows: [___________] |
Issuance Schedule: | Subject to any change on a Capitalization Adjustment, one Share will be issued for each Restricted Share Unit that vests at the time set forth in Section 6 of the Award Agreement. |
ATTACHMENTS: | Restricted Share Unit Agreement (including the Appendix) and 2025 Inducement Plan |
1. | I have reviewed this Quarterly Report on Form 10-Q of Autolus Therapeutics plc; | |||||||
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; | |||||||
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; | |||||||
4. | The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: | |||||||
(a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | |||||||
(b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; | |||||||
(c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | |||||||
(d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and | |||||||
5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): | |||||||
(a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and | |||||||
(b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: May 8, 2025 | /s/ Christian Itin, Ph.D. | ||||
Name: Christian Itin, Ph.D. | |||||
Title: Chief Executive Officer | |||||
(Principal Executive Officer) |
1. | I have reviewed this Quarterly Report on Form 10-Q of Autolus Therapeutics plc; | |||||||
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; | |||||||
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; | |||||||
4. | The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: | |||||||
(a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | |||||||
(b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; | |||||||
(c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | |||||||
(d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and | |||||||
5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): | |||||||
(a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and | |||||||
(b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: May 8, 2025 | /s/ Robert Dolski | ||||
Name: Robert Dolski | |||||
Title: Chief Financial Officer | |||||
(Principal Financial Officer) |
(1) | The Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, to which this Certification is attached as Exhibit 32.1 (the “Periodic Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and |
(2) | The information contained in the Quarterly Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Date: May 8, 2025 |
/s/ Christian Itin, Ph.D. | /s/ Robert Dolski. | |||||||
Name: Christian Itin, Ph.D. | Name: Robert Dolski | |||||||
Title: Chief Executive Officer | Title: Chief Financial Officer | |||||||
(Principal Executive Officer) | (Principal Financial Officer) |
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)(Parenthetical) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2025 |
Mar. 31, 2024 |
|
Income Statement [Abstract] | ||
Unrealized holding losses on available-for-sale debt securities, net of tax | $ 0 | $ 0 |
Unaudited Condensed Consolidated Statements of Shareholders’ Equity - USD ($) |
Total |
Ordinary shares |
Deferred Class A Shares |
Deferred Class B Shares |
Deferred Class C Shares |
Common shares
Ordinary shares
|
Common shares
Deferred Class A Shares
|
Common shares
Deferred Class B Shares
|
Common shares
Deferred Class C Shares
|
Additional Paid in Capital |
Accumulated other comprehensive loss |
Accumulated deficit |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Beginning balance (in shares) at Dec. 31, 2023 | 174,101,361 | 34,425 | 88,893,548 | 1 | ||||||||
Beginning balance at Dec. 31, 2023 | $ 111,474,000 | $ 8,000 | $ 0 | $ 118,000 | $ 0 | $ 1,018,902,000 | $ (28,992,000) | $ (878,562,000) | ||||
Stockholders' Equity | ||||||||||||
Issuance of ordinary shares, net of issuance costs (in shares) | 91,666,669 | |||||||||||
Issuance of ordinary shares, net of issuance costs | 520,617,000 | $ 4,000 | 520,613,000 | |||||||||
Share-based compensation expense | 2,286,000 | 2,286,000 | ||||||||||
Vesting of restricted stock unit awards net of shares withheld to cover tax withholding (in shares) | 57,524 | |||||||||||
Exercise of share options (in shares) | 102,469 | |||||||||||
Exercise of share options | 285,000 | 285,000 | ||||||||||
Other comprehensive income | 58,000 | 58,000 | ||||||||||
Net loss | (52,690,000) | (52,690,000) | ||||||||||
Ending balance (in shares) at Mar. 31, 2024 | 265,928,023 | 34,425 | 88,893,548 | 1 | ||||||||
Ending balance at Mar. 31, 2024 | 582,030,000 | $ 12,000 | $ 0 | $ 118,000 | $ 0 | 1,542,086,000 | (28,934,000) | (931,252,000) | ||||
Beginning balance (in shares) at Dec. 31, 2024 | 266,125,337 | 34,425 | 88,893,548 | 1 | 266,121,689 | 34,425 | 88,893,548 | 1 | ||||
Beginning balance at Dec. 31, 2024 | 427,325,000 | $ 12,000 | $ 0 | $ 118,000 | $ 0 | 1,555,593,000 | (29,174,000) | (1,099,224,000) | ||||
Stockholders' Equity | ||||||||||||
Share-based compensation expense | 2,876,000 | 2,876,000 | ||||||||||
Vesting of restricted stock unit awards net of shares withheld to cover tax withholding (in shares) | 3,648 | |||||||||||
Other comprehensive income | 11,068,000 | 11,068,000 | ||||||||||
Net loss | (70,161,000) | (70,161,000) | ||||||||||
Ending balance (in shares) at Mar. 31, 2025 | 266,141,411 | 34,425 | 88,893,548 | 1 | 266,125,337 | 34,425 | 88,893,548 | 1 | ||||
Ending balance at Mar. 31, 2025 | $ 371,108,000 | $ 12,000 | $ 0 | $ 118,000 | $ 0 | $ 1,558,469,000 | $ (18,106,000) | $ (1,169,385,000) |
Nature of the Business |
3 Months Ended |
---|---|
Mar. 31, 2025 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of the Business | 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 United States 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 United States for the treatment of adult patients (18 years and older) with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (“r/r B-ALL”). The commercial launch and first sale of AUCATZYL in the United States occurred in January 2025. The United Kingdom Medicines and Healthcare products Regulatory Agency (“MHRA”) granted AUCATZYL conditional marketing authorization in April 2025, and Autolus anticipates commercial launch in the United Kingdom in the second half of 2025. Obe-cel is under regulatory review in the European Union (the “EU”) for the treatment of r/r B-ALL, with marketing authorization submission accepted by the European Medicines Agency (“EMA”) in April 2024, and the Company expects to receive notification of approval status from the EMA in the second half of 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. The Company also expects to incur significant additional costs as it expands its commercialization efforts for AUCATZYL. 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 United States 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 United States 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 United States domestic issuer forms, the Company will maintain its status as a foreign private issuer and is not subject to certain other requirements imposed on United States 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.
|
Summary of Significant Accounting Policies |
3 Months Ended |
---|---|
Mar. 31, 2025 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited condensed consolidated interim financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X, and are presented in US dollars. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. The condensed consolidated balance sheet at December 31, 2024, has been derived from the audited consolidated financial statements at that date but does not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. The significant accounting policies used in the preparation of these unaudited condensed consolidated interim financial statements are consistent with those discussed in Note 2, “Summary of Significant Accounting Policies” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on March 20, 2025 (the “Annual Report”). The information included in these unaudited condensed consolidated interim financial statements should be read in conjunction with the audited consolidated financial statements and the related notes thereto as of and for the year ended December 31, 2024, included in the Annual Report. These condensed consolidated interim financial statements include all adjustments, consisting of normal recurring adjustments, which, in the opinion of management, are necessary to fairly state the Company’s financial position as of March 31, 2025, and the results of its operation and cash flows for the three-month period ended March 31, 2025. The interim results and cash flows are not necessarily indicative of results and cash flows that may be expected for the year ending December 31, 2025. Going Concern The Company has incurred recurring losses since its inception, including net losses of $70.2 million and $52.7 million for the three months ended March 31, 2025 and 2024, respectively. The Company had an accumulated deficit of $1,169.4 million and $1,099.2 million as of March 31, 2025 and December 31, 2024, respectively. The Company expects to continue to generate operating losses in the foreseeable future. The Company’s inability to raise additional capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies. There can be no assurances, however, that the current operating plan will be achieved or that additional funding will be available on terms acceptable to the Company, or at all. The Company expects that its cash and cash equivalents and marketable securities of $95.8 million and $420.8 million, respectively, as of March 31, 2025, will be sufficient to fund the Company’s operations for at least twelve months from the issuance date of these unaudited condensed consolidated interim financial statements and accordingly they have been prepared on a going concern basis. 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 current and future commercialization efforts, additional funding may be needed before the Company is expected become profitable. Use of Estimates The preparation of condensed consolidated interim financial statements in conformity with U.S. 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, 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, incremental borrowing rates related to the Company’s leased properties, allocation of transaction price using the relative standalone selling price relating to license revenue and the estimated expected rebate and chargeback percentage for revenue deductions related to product revenue, net. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from those estimates. Expected rebate and chargeback percentage for product revenue deductions Since approval of AUCATZYL in November 2024, Autolus has a short history of actual rebate claims or chargebacks, and such information may have limited predictive value. The Company uses the expected value method to estimate expected rebate and chargeback percentages for revenue deductions, which considers the likelihood of a rebate or chargeback being applicable to sales. The proportion of sales subject to a rebate or chargeback is inherently uncertain and estimates are based on internal assumptions, which may change as it develops more product revenue experience, and third-party data, which we assess for reliability and relevance. The Company is subject to state government Medicaid and TriCare programs and other qualifying federal and state programs in the United States requiring rebates to be paid to participating state and local government entities, depending on the eligibility and circumstances of patients treated with AUCATZYL. The Company's wholly-owned subsidiary in the United States also participates in programs with government entities, which are the US Department of Defense (the “DoD”), the US Department of Veterans Affairs (the “VA”) and TriCare, and other parties, including covered entities under the 340B Drug Pricing Program (the “340B Program”), whereby pricing on AUCATZYL is extended below list price to participating entities, including Authorized Treatment Centers (“ATCs”). These entities are entitled to purchase AUCATZYL at the lower program price by charging the Company the difference between their acquisition cost and the lower program price. Estimating expected rebate and chargeback percentages for revenue deductions is judgmental due to the time delay between the date of the sale to ATCs and the subsequent dates on which we are able to determine actual amounts of chargebacks and rebates. We form estimates of the 340B Program, the DoD and the VA chargeback deductions by analyzing sell-through data relating to the hospital mix of onward sales made by ATCs. For Medicaid and other rebates, the Company forms estimates based on information obtained from claims received, historical and estimated payor mix, setting of care, discount rates and other industry data, and external health coverage statistics. Judgment is applied to consider the relevance and reliability of information used to make these estimates. The Company's total accrued product revenue deductions as of March 31, 2025 were $0.5 million, including amounts of $0.3 million for the critical estimates subject to greater estimation uncertainty and judgments described above. These are included within accrued expenses and other current liabilities in the condensed consolidated balance sheet as of March 31, 2025. 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. Inventories, Net The Company commences capitalization of inventory once regulatory approval for a product candidate is received. Prior to regulatory approval, 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 for AUCATZYL from this date. There is no pre-launch inventory recognized on the balance sheet as of March 31, 2025 and December 31, 2024. Inventories are measured at the lower of cost or net realizable value, with cost determined using a 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. Consumables consist of materials used primarily in the quality acceptance testing of AUCATZYL and cleaning of the Company’s commercial manufacturing facility and research and development facilities. Raw materials inventory consists of completed materials purchased directly from third party suppliers. Work in progress inventory consists of materials manufactured either by the Company or at contract manufacturing organizations that are either partially manufactured or fully manufactured but are pending quality acceptance release. Finished goods are completed and quality approved drug products that are either awaiting shipment or are in-transit and therefore have not been delivered to the ATCs. Product revenue, net Product revenue The Company accounts for its revenues pursuant to the provisions of ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). The Company has identified a single performance obligation which is satisfied upon delivery of the product to the authorized treatment centers. However, the performance obligation is constrained by the right of return/ credit eligibility which expires when a patient is dosed. The Company recognizes revenue from product sales when the customers’ ability to either cancel the order or request a refund has ceased when the product is administered to the patient. Revenues from product revenue, net of gross-to-net deductions, are recognized only to the extent that a significant reversal in the amount of cumulative revenue recognized is not probable of occurring when the uncertainty associated with gross-to- net deductions is subsequently resolved. Product revenues are recognized net of estimated rebates and chargebacks, patient travel assistance and patient co-pay assistance deductions. These deductions to product revenue are referred to as gross-to-net deductions and are estimated and recorded in the period in which the related product revenue occur. Gross-to-net deductions Rebates and chargebacks Rebates and chargebacks are based on contractual arrangements or statutory requirements and include amounts due to payors and healthcare providers under various programs. These amounts may vary by payor and individual plans. Providers qualified under certain programs can purchase the Company's products through our third-party logistics partner at a discount. Our third-party logistics partner then charge the discount back to the Company. Rebates and chargebacks are estimated primarily based on product sales, including pricing, historical and estimated payor mix, setting of care and discount rates, among other inputs, which require significant estimates and judgment. The Company assesses and updates its estimates each reporting period to reflect actual claims and other current information. The Company's wholly-owned subsidiary in the United States also participates in programs with government entities, the most significant of which are the DOD, the VA and TriCare, and other parties, including covered entities under the 340B Program, whereby pricing on products is extended below list price to participating entities. These entities purchase products at the lower program price then charge the Company the difference between their acquisition cost and the lower program price. Accounts receivable is reduced for the estimated amount of unprocessed charge-back claims attributable to a sale. The Company's wholly-owned subsidiary in the United States further participates in state government Medicaid programs and the Tricare program requiring discounts and rebates to participating government entities. All discounts and rebates provided through these programs are included in the Company's Medicaid and Tricare rebate accrual. The estimated amount of unpaid or unbilled rebates are to be recognized and presented as a liability. On April 1, 2025, the Centers for Medicare and Medicaid Services (“CMS”) included AUCATZYL in their published Healthcare Common Procedure Coding System (“HCPCS”) coding determinations and Hospital Outpatient Prospective Payment System (“OPPS”) payment rates, formalizing reimbursement for patients on government programs. The CMS policy splits the therapeutic dose of AUCATZYL into two administrations for coding and billing purposes. The Company is working with the treatment centers on implementing the coding and payment policy from CMS and is assessing any potential impact on the timing of revenue recognition and the amount of rebates or chargebacks. Patient Travel, Lodging and Meal Assistance Travel, lodging, and meal assistance represents financial assistance to qualified patients and their caregiver by reimbursing certain travel, lodging, and meal expenses incurred during their treatment. Accrual for these expenses is based on an estimate of qualified patients that the Company expects to receive this assistance at each reporting period. Patient Co-Pay Assistance Co-pay assistance represents financial assistance to qualified patients, assisting them with cost sharing obligations for the Company's product based on benefit design structure required by insurance. The Company's accrual for copay is based on an estimate of claims and the cost per claim that the Company expects to receive associated with qualified patients that exist at each reporting period. 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 foreign exchange gain of $1.2 million and foreign exchange loss of $1.3 million for the three months ended March 31, 2025 and 2024, respectively, which are included in foreign exchange (gains) losses in the unaudited condensed Consolidated Statements of Operations and Comprehensive Income (Loss). Recently Issued Accounting Pronouncements In March 2025, the FASB issued ASU 2025-02, Liabilities (Topic 405): Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 122. (“ASU 2025-02”) which amends the Accounting Standards Codification to remove the text of SEC Staff Accounting Bulletin (“SAB”) 121 “Accounting for Obligations to Safeguard Crypto-Assets an Entity Holds for its Platform Users” as it has been rescinded by the issuance of SAB 122. ASU 2025-02 is effective immediately and on a fully retrospective basis to annual periods beginning after December 15, 2024. It is not expected to have an impact on the Company’s consolidated financial statements. 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 adopted ASU 2024-02 on January 1, 2025 and will apply ASU 2024-02 prospectively to all new transactions recognized on or after the adoption date. The adoption of ASU 2024-02 did not have material effect on the Company's condensed consolidated financial statements and related disclosures for the three months ended March 31, 2025. 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 adopted ASU 2024-01 on January 1, 2025. The adoption of ASU 2024-01 did not have material effect on the Company's condensed consolidated financial statements and related disclosures for the three months ended March 31, 2025. 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 does not expect the adoption of ASU 2023-09 to have a material effect on condensed consolidated financial statements and related disclosures for the three months ended March 31, 2025. Unless otherwise discussed, the impact of recently issued standards that are not yet effective are not expected to have a material impact on the Company’s consolidated financial statements and disclosures.
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Revenue |
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Revenue from Contract with Customer [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue | 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 United States for the treatment of adult patients with r/r B-ALL. Product revenue, net recognized after estimated deductions for rebates, chargebacks and returns for the three months ended March 31, 2025, and 2024, is presented in the table below by geographical location (in thousands):
During the three months ended March 31, 2025, 100% of the Company's product revenue, net was generated through the Company's agent Cardinal Health 105, LLC (“Cardinal Health”) from ATCs on behalf of patients. Accounts receivable from contracts with customers Accounts receivable as of March 31, 2025 and December 31, 2024 was $14.3 million and less than $0.1 million, respectively. An allowance for lifetime expected credit losses on accounts receivable is measured using historical credit loss experience, conditions at the end of each reporting period, and reasonable and supportable forecasts that affect collectability. Expected credit losses as of March 31, 2025 and December 31, 2024 were immaterial. Accruals for rebates, chargebacks and returns Current and non-current accruals for rebates and chargebacks as of March 31, 2025 were as follows (in thousands):
License revenue, net License revenue for the three months ended March 31, 2025, and 2024, is presented in the table below by geographical location (in thousands):
Major customers The Company did not recognize any license revenue during the three months ended March 31, 2025. During the three months ended March 31, 2024, 100% of the Company’s license revenues were generated from BioNTech. License and Option Agreement with BioNTech On February 6, 2024, the Company concurrently entered into the BioNTech Agreements. For further details on the terms and accounting treatment considerations for the BioNTech Agreement, refer to following notes to these interim condensed consolidated financial statements: •Note 2, “Summary of significant accounting policies” •Note 13, “Shareholders’ equity” •Note 15, “Liabilities related to future royalties and milestones, net” •Note 17, “Commitments and contingencies” As the BioNTech License and Option Agreement (as defined below) has been accounted for as one 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, Derivatives and Hedging (“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 identified one 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 the one 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 three months ended March 31, 2024. No license revenue was recognized during the three months ended March 31, 2025. 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 and will 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 March 31, 2025 and 2024, respectively. Technology Options As the Binder Option and the Activity Enhancement Option, the (“Technology Options”) are outside the scope of ASC 815, the Company considered other relevant accounting guidance to apply to this component of the BioNTech License and Option Agreement. The Company therefore 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 three months ended March 31, 2025 and 2024, respectively. Product Options As the option to obtain exclusive rights to co-fund development costs of the Company’s development-stage programs AUTO1/22 and AUTO6NG (“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 ASC 606, and no recognition is required under ASC 450, until the Product Options are exercised. No Product Options were exercised during the three months ended March 31, 2025 and 2024, respectively. The product option for AUTO1/22 was not exercised and has expired as of February 8, 2025.
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Interest Expense, Net | Interest Expense, Net Interest expense consisted of the following (in thousands):
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Net Loss Per Share |
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Net Loss Per Share | Net Loss Per Share Basic and diluted net loss per share was calculated as follows (in thousands, except share and per share amounts):
For all periods presented, outstanding but unvested restricted stock units, 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 is 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:
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Fair Value Measurements |
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Fair Value Measurements | 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 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 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 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. 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):
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 observable market prices are not available (such as for securities with short maturities and limited second market activity), the securities are priced using a valuation model that maximizes the use of observable inputs, such as market interest rates. As of March 31, 2025 and December 31, 2024, the Company did not have non-financial assets measured at fair value on a recurring basis. During the three months ended March 31, 2025 and the year ended December 31, 2024, there were no transfers between fair value levels.
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Marketable Securities: Available-For-Sale Debt Securities |
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Mar. 31, 2025 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investments, Debt and Equity Securities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Marketable Securities: Available-For-Sale Debt Securities | Marketable Securities: Available-For-Sale Debt Securities As of March 31, 2025 and 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):
The number of securities held by the Company and aggregate fair value (in thousands) and in an unrealized loss position as of March 31, 2025 and December 31, 2024 are as follows (in thousands):
The aggregated net unrealized loss on available-for-sale debt securities in the amount of $0.1 million has been recognized in accumulated other comprehensive loss in the Company's condensed consolidated balance sheet as of March 31, 2025. At March 31, 2025, the Company held 37 marketable securities: available-for-sale debt securities out of its total investment portfolio that were in a continuous unrealized loss position. As of March 31, 2025, 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 intends to sell these investments nor has concluded that it will more-likely-than-not have to sell them before recovery of their carrying values. The Company also believes 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 three months ended March 31, 2025. There were no available-for-sale debt securities as of December 31, 2024.
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Inventories, Net |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2025 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventories, Net | Inventories, Net Inventories consisted of the following (in thousands):
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Prepaid Expenses and Other Current Assets |
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Mar. 31, 2025 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Prepaid Expenses and Other Current Assets | Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following (in thousands):
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Property and Equipment, Net |
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Mar. 31, 2025 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property, Plant and Equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property and Equipment, Net | Property and Equipment, Net Property and equipment, net consisted of the following (in thousands):
Depreciation expense for the three months ended March 31, 2025 and 2024 was $2.0 million and $1.8 million, respectively.
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Intangible Assets, Net |
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Goodwill and Intangible Assets Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Intangible Assets, Net | Intangible Assets, Net The following table summarizes the carrying amount of the Company's intangible assets, net of accumulated amortization (in thousands):
Amortization expense was $0.3 million and nil for the three months ended March 31, 2025 and 2024, respectively. The estimated annual amortization expense related to this asset is $1.1 million for each of the five years ending in 2029.
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Accrued Expenses and Other Liabilities |
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Payables and Accruals [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accrued Expenses and Other Liabilities | Accrued Expenses and Other Liabilities Accrued expenses and other liabilities consisted of the following (in thousands):
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Shareholders’ Equity |
3 Months Ended |
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Mar. 31, 2025 | |
Equity [Abstract] | |
Shareholders’ Equity | 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 Company’s board of directors and declared by the shareholders. As of March 31, 2025, the Company has not declared any dividends. Restricted Stock Units At March 31, 2025, restricted stock unit awards for 16,074 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 March 31, 2025 as they are considered issuable for little or no cash consideration. Subsequent to March 31, 2025, 12,500 of the underlying ordinary shares were issued. 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 3 and Note 15), the Company and BioNTech entered into the BioNTech Securities Purchase Agreement (as defined below) pursuant to which the Company sold ADSs, each representing one ordinary share, to BioNTech in a private placement transaction (the “Private Placement”). 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 a joint manufacturing and commercial services agreement 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.
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Share-Based Compensation |
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Share-Based Payment Arrangement [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-Based Compensation | Share-Based Compensation The following table summarizes the total share-based compensation expense included in the unaudited condensed Consolidated Statements of Operations and Comprehensive Income (Loss) (in thousands):
Share Options The table below summarizes Company’s share option activity during the three months ended March 31, 2025:
The weighted average grant-date fair value of share options granted was $1.34 per share option for the three months ended March 31, 2025. The weighted average grant-date fair value of share options granted was $4.53, per share option for the three months ended March 31, 2024. The total intrinsic value of share options exercised was nil for the three months ended March 31, 2025. The total intrinsic value of options exercised was $0.3 million for the three months ended March 31, 2024. As of March 31, 2025, the total unrecognized compensation expense related to unvested share options without performance conditions was $22.2 million, which the Company expects to recognize over a weighted average vesting period of 3.51 years. Restricted Stock Units The table below summarizes Company’s restricted stock unit (“RSU”) awards activity during the three months ended March 31, 2025:
As of March 31, 2025, there was less than $0.1 million of unrecognized share-based compensation expense related to unvested RSUs without performance conditions, which is expected to be recognized over a weighted average period of 1.07 years.
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Liabilities Related to Future Royalties and Milestones, Net |
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Investments, Debt and Equity Securities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Liabilities Related to Future Royalties and Milestones, Net | 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):
The following table summarizes the current versus non-current split of the liabilities related to future royalties and milestones, net (in thousands):
During the three months ended March 31, 2025 and 2024, interest expense on liabilities related to future royalties and milestones, net amounted to $10.1 million and $8.4 million, respectively. During the three months ended March 31, 2025 and 2024, cumulative catch-up adjustment (included in interest expense) amounted to nil and $10.9 million, respectively. Blackstone Collaboration Agreement On November 6, 2021, the Company concurrently entered into the following agreements with BXLS V - Autobahn L.P, (“Blackstone”): (i) Strategic Collaboration Agreement (the “Blackstone Collaboration Agreement”), (ii) Securities Purchase Agreement (the “Blackstone Securities Purchase Agreement”), (iii) Warrant Agreement (the “Blackstone Warrant”) and (iv) Registration Rights Agreement (the “Blackstone Registration Rights Agreement”). The Blackstone Collaboration Agreement, the Blackstone Securities Purchase Agreement, the Blackstone Warrant and the Blackstone Registration Rights Agreement are collectively referred to as the “Blackstone Agreements”. The Blackstone Agreements were entered into and in contemplation of one another and, accordingly, the Company assessed the accounting for the Blackstone Agreements in the aggregate. For further details on the terms and accounting treatment considerations for these contracts, please refer to following notes to the Company’s consolidated financial statements contained in the Company’s Annual Report: •Note 2, “Summary of significant accounting policies” •Note 12, “Liabilities related to future royalties and milestones, net” •Note 13, “Warrants” •Note 14, “Shareholders’ equity” In November 2021, the upfront payment of $50.0 million was paid by Blackstone upon execution of the Blackstone Collaboration Agreement. In December 2022, two Blackstone Development Payments were paid by Blackstone of $35.0 million each as a result of (i) the joint steering committee’s review of the Company’s interim analysis of pivotal FELIX Phase 2 clinical trial of obe-cel in r/r 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. On November 8, 2024, the Company was notified by the FDA that the Company has been granted marketing approval for AUCATZYL for the treatment of adult patients (18 years and older) with r/r B-ALL. The remaining $30.0 million of Blackstone Development Payments are now payable to the Company as a result of such approval. BioNTech Agreements On February 6, 2024, the Company concurrently entered into a (i) Securities Purchase Agreement (the “BioNTech Securities Purchase Agreement”), (ii) Registration Rights Agreement, (iii) Letter Agreement and (iv) 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. For further details on the terms and accounting treatment considerations for these contracts, please refer to following notes to the Company’s consolidated financial statements contained in the Company’s Annual Report: •Note 1, “Nature of the business” •Note 2, “Summary of significant accounting policies” •Note 3, “Revenue” •Note 12, “Liabilities related to future royalties and milestones, net” •Note 14, “Shareholders’ equity” •Note 20, “Commitments and contingencies” Obe-cel Product Revenue Interest Under the BioNTech License and Option Agreement, BioNTech has agreed to financially support the expansion of the clinical development program for, and planned commercialization of obe-cel. In exchange for the grant of rights to future revenues from the sales of obe-cel products, 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. The Company has accounted for the Obe-cel Product Revenue Interest as 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. 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 carrying amount of the Blackstone Collaboration Liability and 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 using the initial effective interest rate. The imputed rate of interest on the unamortized portion of the Blackstone Collaboration Liability and BioNTech Liability was approximately 15.80% and 28.70% as of March 31, 2025, respectively. 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. To the extent the present value of such payments is greater or less than its initial estimates or the timing of such payments is materially different than its original estimates, the Company will adjust the amortization of the BioNTech Liability using the cumulative catch-up method.
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Leases |
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Leases | Leases Operating leases - Lessee The Company leases certain office space, laboratory space, and equipment. 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. The Company’s costs as a lessee for the three months ended March 31, 2025 and 2024 were as follows (in thousands):
Supplemental cash flow information for the three months ended March 31, 2025 and 2024 were as follows (in thousands):
The weighted average remaining lease term and weighted average discount rate of operating leases as of March 31, 2025 and 2024 were as follows:
The maturities of operating lease liabilities as of March 31, 2025 were as follows (in thousands):
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Commitments and Contingencies |
3 Months Ended |
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Mar. 31, 2025 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Contractual obligations In July 2022, the Company renegotiated a 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 three months ended March 31, 2024, the Company paid a fee under these agreements. There were no fees paid or payable to strategic advisory firms during the three months ended March 31, 2025 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 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 March 31, 2025, there were no other milestones for which the likelihood of achievement was currently probable. Capital Commitments As of March 31, 2025, the Company’s unconditional purchase obligations for capital expenditures totaled $16.4 million and included signed orders for capital equipment and capital expenditures for construction and related expenditures relating to its properties in the United Kingdom and United States. The Company expects to incur the full amount of these obligations within one year. Master Supply Commitments As of March 31, 2025, the Company’s unconditional purchase obligations with Miltenyi Biotec GmbH for reagents and consumables totaled $2.9 million, which the Company expects to incur within one year. BioNTech Agreements 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 March 31, 2025 and December 31, 2024, Product Options were not exercised and therefore no amounts were recognized. Refer to Note 15, “Liabilities related to future royalties and milestones, net” for further details about the BioNTech Agreements. 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 March 31, 2025 and December 31, 2024. 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 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 United Kingdom tax authority. The tax authority based on their non-statutory guidance, included some expenditure in the calculation of whether a company meets the R&D intensive scheme, which is in conflict with the criteria in the tax legislation. The position is uncertain and the legislation is currently untested in the United Kingdom 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.
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Segment Reporting |
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Segment Reporting [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Segment Reporting | Segment Reporting Long-lived assets Long-lived assets (excluding intangibles, deferred tax and financial instruments) were located as follows (in thousands):
Revenue Revenue recognized by geographic area are disclosed in Note 3, “Revenue”. Segment profit or loss The table below is a summary of the segment profit or loss, including significant segment expenses (in thousands):
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Related Party Transactions |
3 Months Ended |
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Mar. 31, 2025 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Related Party Transactions Blackstone Agreements In November 2021, the Company concurrently entered into the Blackstone Agreements. As of the execution of the Blackstone Agreements, Blackstone became a related party of the Company, as Blackstone became the owner of more than 10% of the Company’s outstanding voting securities. In addition, Blackstone received and exercised its right to nominate one director to the board of directors of the Company and is therefore considered to be one of the principal owners of the Company. As of March 31, 2025, the carrying amount of the Blackstone Collaboration Agreement Liability was $219.4 million which included aggregated cumulative non-cash interest expense and cumulative catch-up adjustment of $7.8 million. As of December 31, 2024, the carrying amount of the Blackstone Collaboration Agreement Liability was $211.6 million which included aggregated cumulative non-cash interest expense (including cumulative catch-up adjustments), of $10.7 million. Refer to Note 15, “Liabilities related to future royalties and milestones, net” for further details. BioNTech Agreements 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 nominate one director to the board of directors of the Company which BioNTech has not yet exercised. As of March 31, 2025, the carrying amount of the BioNTech Liability was $38.8 million which included aggregated cumulative interest expense and cumulative catch-up adjustment of $2.3 million. As of December 31, 2024, the carrying amount of the BioNTech Liability was $36.5 million which included aggregated cumulative non-cash interest expense (including cumulative catch-up adjustments), of $1.8 million. Refer to Note 15, “Liabilities related to future royalties and milestones, net” for further details.
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Subsequent Events |
3 Months Ended |
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Mar. 31, 2025 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events The Company evaluated subsequent events through May 8, 2025, the date on which these unaudited condensed consolidated financial statements were issued. The United Kingdom Medicines and Healthcare products Regulatory Agency (“MHRA”) granted AUCATZYL conditional marketing authorization on April 25, 2025, and the Company anticipates commercial launch in the United Kingdom in the second half of 2025.
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Pay vs Performance Disclosure - USD ($) $ in Thousands |
3 Months Ended | |
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Mar. 31, 2025 |
Mar. 31, 2024 |
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Pay vs Performance Disclosure | ||
Net loss | $ (70,161) | $ (52,690) |
Insider Trading Arrangements |
3 Months Ended |
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Mar. 31, 2025 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Summary of Significant Accounting Policies (Policies) |
3 Months Ended |
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Mar. 31, 2025 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated interim financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X, and are presented in US dollars. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. The condensed consolidated balance sheet at December 31, 2024, has been derived from the audited consolidated financial statements at that date but does not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. The significant accounting policies used in the preparation of these unaudited condensed consolidated interim financial statements are consistent with those discussed in Note 2, “Summary of Significant Accounting Policies” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on March 20, 2025 (the “Annual Report”). The information included in these unaudited condensed consolidated interim financial statements should be read in conjunction with the audited consolidated financial statements and the related notes thereto as of and for the year ended December 31, 2024, included in the Annual Report. These condensed consolidated interim financial statements include all adjustments, consisting of normal recurring adjustments, which, in the opinion of management, are necessary to fairly state the Company’s financial position as of March 31, 2025, and the results of its operation and cash flows for the three-month period ended March 31, 2025. The interim results and cash flows are not necessarily indicative of results and cash flows that may be expected for the year ending December 31, 2025.
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Going Concern | Going Concern The Company has incurred recurring losses since its inception, including net losses of $70.2 million and $52.7 million for the three months ended March 31, 2025 and 2024, respectively. The Company had an accumulated deficit of $1,169.4 million and $1,099.2 million as of March 31, 2025 and December 31, 2024, respectively. The Company expects to continue to generate operating losses in the foreseeable future. The Company’s inability to raise additional capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies. There can be no assurances, however, that the current operating plan will be achieved or that additional funding will be available on terms acceptable to the Company, or at all. The Company expects that its cash and cash equivalents and marketable securities of $95.8 million and $420.8 million, respectively, as of March 31, 2025, will be sufficient to fund the Company’s operations for at least twelve months from the issuance date of these unaudited condensed consolidated interim financial statements and accordingly they have been prepared on a going concern basis. 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 current and future commercialization efforts, additional funding may be needed before the Company is expected become profitable.
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Use of Estimates | Use of Estimates The preparation of condensed consolidated interim financial statements in conformity with U.S. 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, 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, incremental borrowing rates related to the Company’s leased properties, allocation of transaction price using the relative standalone selling price relating to license revenue and the estimated expected rebate and chargeback percentage for revenue deductions related to product revenue, net. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from those estimates. Expected rebate and chargeback percentage for product revenue deductions Since approval of AUCATZYL in November 2024, Autolus has a short history of actual rebate claims or chargebacks, and such information may have limited predictive value. The Company uses the expected value method to estimate expected rebate and chargeback percentages for revenue deductions, which considers the likelihood of a rebate or chargeback being applicable to sales. The proportion of sales subject to a rebate or chargeback is inherently uncertain and estimates are based on internal assumptions, which may change as it develops more product revenue experience, and third-party data, which we assess for reliability and relevance. The Company is subject to state government Medicaid and TriCare programs and other qualifying federal and state programs in the United States requiring rebates to be paid to participating state and local government entities, depending on the eligibility and circumstances of patients treated with AUCATZYL. The Company's wholly-owned subsidiary in the United States also participates in programs with government entities, which are the US Department of Defense (the “DoD”), the US Department of Veterans Affairs (the “VA”) and TriCare, and other parties, including covered entities under the 340B Drug Pricing Program (the “340B Program”), whereby pricing on AUCATZYL is extended below list price to participating entities, including Authorized Treatment Centers (“ATCs”). These entities are entitled to purchase AUCATZYL at the lower program price by charging the Company the difference between their acquisition cost and the lower program price. Estimating expected rebate and chargeback percentages for revenue deductions is judgmental due to the time delay between the date of the sale to ATCs and the subsequent dates on which we are able to determine actual amounts of chargebacks and rebates. We form estimates of the 340B Program, the DoD and the VA chargeback deductions by analyzing sell-through data relating to the hospital mix of onward sales made by ATCs. For Medicaid and other rebates, the Company forms estimates based on information obtained from claims received, historical and estimated payor mix, setting of care, discount rates and other industry data, and external health coverage statistics. Judgment is applied to consider the relevance and reliability of information used to make these estimates. The Company's total accrued product revenue deductions as of March 31, 2025 were $0.5 million, including amounts of $0.3 million for the critical estimates subject to greater estimation uncertainty and judgments described above. These are included within accrued expenses and other current liabilities in the condensed consolidated balance sheet as of March 31, 2025.
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Segment Information | 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.
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Inventories, Net | Inventories, Net The Company commences capitalization of inventory once regulatory approval for a product candidate is received. Prior to regulatory approval, 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 for AUCATZYL from this date. There is no pre-launch inventory recognized on the balance sheet as of March 31, 2025 and December 31, 2024. Inventories are measured at the lower of cost or net realizable value, with cost determined using a 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. Consumables consist of materials used primarily in the quality acceptance testing of AUCATZYL and cleaning of the Company’s commercial manufacturing facility and research and development facilities. Raw materials inventory consists of completed materials purchased directly from third party suppliers. Work in progress inventory consists of materials manufactured either by the Company or at contract manufacturing organizations that are either partially manufactured or fully manufactured but are pending quality acceptance release. Finished goods are completed and quality approved drug products that are either awaiting shipment or are in-transit and therefore have not been delivered to the ATCs.
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Product revenue, net | Product revenue, net Product revenue The Company accounts for its revenues pursuant to the provisions of ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). The Company has identified a single performance obligation which is satisfied upon delivery of the product to the authorized treatment centers. However, the performance obligation is constrained by the right of return/ credit eligibility which expires when a patient is dosed. The Company recognizes revenue from product sales when the customers’ ability to either cancel the order or request a refund has ceased when the product is administered to the patient. Revenues from product revenue, net of gross-to-net deductions, are recognized only to the extent that a significant reversal in the amount of cumulative revenue recognized is not probable of occurring when the uncertainty associated with gross-to- net deductions is subsequently resolved. Product revenues are recognized net of estimated rebates and chargebacks, patient travel assistance and patient co-pay assistance deductions. These deductions to product revenue are referred to as gross-to-net deductions and are estimated and recorded in the period in which the related product revenue occur. Gross-to-net deductions Rebates and chargebacks Rebates and chargebacks are based on contractual arrangements or statutory requirements and include amounts due to payors and healthcare providers under various programs. These amounts may vary by payor and individual plans. Providers qualified under certain programs can purchase the Company's products through our third-party logistics partner at a discount. Our third-party logistics partner then charge the discount back to the Company. Rebates and chargebacks are estimated primarily based on product sales, including pricing, historical and estimated payor mix, setting of care and discount rates, among other inputs, which require significant estimates and judgment. The Company assesses and updates its estimates each reporting period to reflect actual claims and other current information. The Company's wholly-owned subsidiary in the United States also participates in programs with government entities, the most significant of which are the DOD, the VA and TriCare, and other parties, including covered entities under the 340B Program, whereby pricing on products is extended below list price to participating entities. These entities purchase products at the lower program price then charge the Company the difference between their acquisition cost and the lower program price. Accounts receivable is reduced for the estimated amount of unprocessed charge-back claims attributable to a sale. The Company's wholly-owned subsidiary in the United States further participates in state government Medicaid programs and the Tricare program requiring discounts and rebates to participating government entities. All discounts and rebates provided through these programs are included in the Company's Medicaid and Tricare rebate accrual. The estimated amount of unpaid or unbilled rebates are to be recognized and presented as a liability. On April 1, 2025, the Centers for Medicare and Medicaid Services (“CMS”) included AUCATZYL in their published Healthcare Common Procedure Coding System (“HCPCS”) coding determinations and Hospital Outpatient Prospective Payment System (“OPPS”) payment rates, formalizing reimbursement for patients on government programs. The CMS policy splits the therapeutic dose of AUCATZYL into two administrations for coding and billing purposes. The Company is working with the treatment centers on implementing the coding and payment policy from CMS and is assessing any potential impact on the timing of revenue recognition and the amount of rebates or chargebacks. Patient Travel, Lodging and Meal Assistance Travel, lodging, and meal assistance represents financial assistance to qualified patients and their caregiver by reimbursing certain travel, lodging, and meal expenses incurred during their treatment. Accrual for these expenses is based on an estimate of qualified patients that the Company expects to receive this assistance at each reporting period. Patient Co-Pay Assistance Co-pay assistance represents financial assistance to qualified patients, assisting them with cost sharing obligations for the Company's product based on benefit design structure required by insurance. The Company's accrual for copay is based on an estimate of claims and the cost per claim that the Company expects to receive associated with qualified patients that exist at each reporting period.
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Foreign Currency Translation | 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 foreign exchange gain of $1.2 million and foreign exchange loss of $1.3 million for the three months ended March 31, 2025 and 2024, respectively, which are included in foreign exchange (gains) losses in the unaudited condensed Consolidated Statements of Operations and Comprehensive Income (Loss).
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Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In March 2025, the FASB issued ASU 2025-02, Liabilities (Topic 405): Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 122. (“ASU 2025-02”) which amends the Accounting Standards Codification to remove the text of SEC Staff Accounting Bulletin (“SAB”) 121 “Accounting for Obligations to Safeguard Crypto-Assets an Entity Holds for its Platform Users” as it has been rescinded by the issuance of SAB 122. ASU 2025-02 is effective immediately and on a fully retrospective basis to annual periods beginning after December 15, 2024. It is not expected to have an impact on the Company’s consolidated financial statements. 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 adopted ASU 2024-02 on January 1, 2025 and will apply ASU 2024-02 prospectively to all new transactions recognized on or after the adoption date. The adoption of ASU 2024-02 did not have material effect on the Company's condensed consolidated financial statements and related disclosures for the three months ended March 31, 2025. 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 adopted ASU 2024-01 on January 1, 2025. The adoption of ASU 2024-01 did not have material effect on the Company's condensed consolidated financial statements and related disclosures for the three months ended March 31, 2025. 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 does not expect the adoption of ASU 2023-09 to have a material effect on condensed consolidated financial statements and related disclosures for the three months ended March 31, 2025. Unless otherwise discussed, the impact of recently issued standards that are not yet effective are not expected to have a material impact on the Company’s consolidated financial statements and disclosures.
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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 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 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 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.
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Revenue (Tables) |
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Schedule of Revenue by Geographical Location | Product revenue, net recognized after estimated deductions for rebates, chargebacks and returns for the three months ended March 31, 2025, and 2024, is presented in the table below by geographical location (in thousands):
License revenue for the three months ended March 31, 2025, and 2024, is presented in the table below by geographical location (in thousands):
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Schedule of Accruals for Rebates and Chargebacks | Current and non-current accruals for rebates and chargebacks as of March 31, 2025 were as follows (in thousands):
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Interest Expense, Net (Tables) |
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Schedule of Interest Expense, Net | Interest expense consisted of the following (in thousands):
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Net Loss Per Share (Tables) |
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Schedule of Basic and Diluted Net Loss Per Share | Basic and diluted net loss per share was calculated as follows (in thousands, except share and per share amounts):
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Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The following potentially dilutive securities have been excluded from the calculation of diluted net loss per share due to their anti-dilutive effect:
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Fair Value Measurements (Tables) |
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Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Fair Value Measurements, Recurring and Nonrecurring | 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):
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Marketable Securities: Available-For-Sale Debt Securities (Tables) |
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Mar. 31, 2025 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investments, Debt and Equity Securities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Available-for-Sale Securities by Significant Investment Category | As of March 31, 2025 and 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):
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||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Amount of Gross Unrealized Losses and Estimated Fair Value for Available-for-Sale Securities in an Unrealized Loss Position by Length of Time | The number of securities held by the Company and aggregate fair value (in thousands) and in an unrealized loss position as of March 31, 2025 and December 31, 2024 are as follows (in thousands):
|
Inventories, Net (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2025 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Inventories | Inventories consisted of the following (in thousands):
|
Prepaid Expenses and Other Current Assets (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2025 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consisted of the following (in thousands):
|
Property and Equipment, Net (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2025 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property, Plant and Equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Property and Equipment, Net | Property and equipment, net consisted of the following (in thousands):
|
Intangible Assets, Net (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2025 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Goodwill and Intangible Assets Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Carrying Amount of Intangible Assets | The following table summarizes the carrying amount of the Company's intangible assets, net of accumulated amortization (in thousands):
|
Accrued Expenses and Other Liabilities (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2025 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Payables and Accruals [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Accrued Expenses and Other Liabilities | Accrued expenses and other liabilities consisted of the following (in thousands):
|
Share-Based Compensation (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2025 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-Based Payment Arrangement [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Share-based Compensation Expense | The following table summarizes the total share-based compensation expense included in the unaudited condensed Consolidated Statements of Operations and Comprehensive Income (Loss) (in thousands):
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Schedule of Stock Options | The table below summarizes Company’s share option activity during the three months ended March 31, 2025:
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Schedule of Restricted Stock Units | The table below summarizes Company’s restricted stock unit (“RSU”) awards activity during the three months ended March 31, 2025:
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Liabilities Related to Future Royalties and Milestones, Net (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2025 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investments, Debt and Equity Securities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Liability Related Debt Arising Financial Agreement | The following table summarizes the carrying amount of the Company's liabilities related to future royalties and milestones, net (in thousands):
The following table summarizes the current versus non-current split of the liabilities related to future royalties and milestones, net (in thousands):
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Leases (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2025 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Leases [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Lease Cost | The Company’s costs as a lessee for the three months ended March 31, 2025 and 2024 were as follows (in thousands):
Supplemental cash flow information for the three months ended March 31, 2025 and 2024 were as follows (in thousands):
The weighted average remaining lease term and weighted average discount rate of operating leases as of March 31, 2025 and 2024 were as follows:
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Schedule of Lease Maturity | The maturities of operating lease liabilities as of March 31, 2025 were as follows (in thousands):
|
Segment Reporting (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2025 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Segment Reporting [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Long-Lived Assets by Geographic Location | Long-lived assets (excluding intangibles, deferred tax and financial instruments) were located as follows (in thousands):
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Schedule of Segment Profit or Loss, Including Significant Segment Expenses | The table below is a summary of the segment profit or loss, including significant segment expenses (in thousands):
|
Summary of Significant Accounting Policies - Narrative (Details) - USD ($) $ in Thousands |
3 Months Ended | ||
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Mar. 31, 2025 |
Mar. 31, 2024 |
Dec. 31, 2024 |
|
Marketable Securities [Line Items] | |||
Net loss | $ (70,161) | $ (52,690) | |
Accumulated deficit | (1,169,385) | $ (1,099,224) | |
Cash and cash equivalents | 95,799 | 758,529 | 227,380 |
Marketable securities | 420,776 | $ 360,643 | |
Foreign currency gain (loss) | 1,181 | $ (1,305) | |
Total accrued product revenue deductions | 500 | ||
AUCATZYL and 340B Program | |||
Marketable Securities [Line Items] | |||
Total accrued product revenue deductions | $ 300 |
Revenue - Schedule of Revenue by Geographical Location (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2025 |
Mar. 31, 2024 |
|
Product revenue, net | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | $ 8,982 | $ 0 |
Product revenue, net | United States | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 8,982 | 0 |
License revenue | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 0 | 10,091 |
License revenue | Europe | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | $ 0 | $ 10,091 |
Revenue (Details) |
3 Months Ended |
---|---|
Mar. 31, 2025
USD ($)
| |
Customer Refund Liability, Current and Non-current [Roll Forward] | |
As of December 31, 2024 | $ 0 |
Provisions relates to sales in the period | 468,000 |
Credits and payments made | (129,000) |
As of March 31, 2025 | 339,000 |
Rebates | |
Customer Refund Liability, Current and Non-current [Roll Forward] | |
As of December 31, 2024 | 0 |
Provisions relates to sales in the period | 332,000 |
Credits and payments made | (129,000) |
As of March 31, 2025 | 203,000 |
Chargebacks | |
Customer Refund Liability, Current and Non-current [Roll Forward] | |
As of December 31, 2024 | 0 |
Provisions relates to sales in the period | 136,000 |
Credits and payments made | 0 |
As of March 31, 2025 | $ 136,000 |
Interest Expense, Net (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2025 |
Mar. 31, 2024 |
|
Banking and Thrift, Interest [Abstract] | ||
Interest expense accrued on liabilities related to future royalties and milestones, net | $ 10,138 | $ 8,390 |
Cumulative catch-up adjustment arising from the liabilities related to future royalties and milestones, net | 0 | 10,870 |
Other interest expense | 5 | 9 |
Total interest expense | $ 10,143 | $ 19,269 |
Net Loss Per Share - Schedule of Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2025 |
Mar. 31, 2024 |
|
Numerator | ||
Net loss | $ (70,161) | $ (52,690) |
Net loss - basic | (70,161) | (52,690) |
Net loss - diluted | $ (70,161) | $ (52,690) |
Denominator | ||
Weighted-average number of ordinary shares used in net loss per share - basic (in shares) | 266,126,548 | 222,170,707 |
Weighted-average number of ordinary shares used in net loss per share - diluted (in shares) | 266,126,548 | 222,170,707 |
Earnings Per Share | ||
Net loss per share - basic (in usd per share) | $ (0.26) | $ (0.24) |
Net loss per share - diluted (in usd per share) | $ (0.26) | $ (0.24) |
Net Loss Per Share - Schedule of Anti-dilutive Securities (Details) - shares |
3 Months Ended | |
---|---|---|
Mar. 31, 2025 |
Mar. 31, 2024 |
|
Antidilutive Securities | ||
Total potentially dilutive securities (in shares) | 33,760,361 | 21,042,674 |
Unvested restricted stock units | ||
Antidilutive Securities | ||
Total potentially dilutive securities (in shares) | 16,250 | 45,719 |
Share options | ||
Antidilutive Securities | ||
Total potentially dilutive securities (in shares) | 30,478,805 | 17,731,649 |
Warrants | ||
Antidilutive Securities | ||
Total potentially dilutive securities (in shares) | 3,265,306 | 3,265,306 |
Marketable Securities: Available-For-Sale Debt Securities - Narrative (Details) $ in Thousands |
Mar. 31, 2025
USD ($)
security
|
Dec. 31, 2024
USD ($)
security
|
---|---|---|
Debt Securities, Available-for-Sale, Unrealized Loss Position [Line Items] | ||
Aggregated unrealized loss on available-for-sale debt securities | $ 91 | $ 344 |
Number of securities held | security | 37 | 56 |
Debt Securities, Available-for-Sale | ||
Debt Securities, Available-for-Sale, Unrealized Loss Position [Line Items] | ||
Aggregated unrealized loss on available-for-sale debt securities | $ 100 |
Inventories, Net - Schedule of Inventories (Details) - USD ($) $ in Thousands |
Mar. 31, 2025 |
Dec. 31, 2024 |
---|---|---|
Inventory Disclosure [Abstract] | ||
Consumables | $ 4,756 | $ 2,026 |
Raw materials | 3,046 | 1,956 |
Work in progress | 5,431 | 16 |
Finished goods | 1,414 | 140 |
Total inventories, net | $ 14,647 | $ 4,138 |
Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands |
Mar. 31, 2025 |
Dec. 31, 2024 |
---|---|---|
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Research and development claims receivable | $ 41,790 | $ 38,242 |
Prepayments | 13,719 | 15,212 |
VAT receivable | 5,500 | 5,996 |
Deferred cost | 2,420 | 2,320 |
Accrued interest income | 2,349 | 2,566 |
Other assets | 1,621 | 1,571 |
Lease and lease deposit receivable | 960 | 930 |
Other receivables | 423 | 491 |
Prepaid expenses and other current assets | $ 68,782 | $ 67,328 |
Property and Equipment, Net - Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands |
Mar. 31, 2025 |
Dec. 31, 2024 |
---|---|---|
Property, Plant and Equipment | ||
Less: accumulated depreciation | $ (37,689) | $ (34,618) |
Total property and equipment, net | 57,970 | 49,553 |
Lab equipment | ||
Property, Plant and Equipment | ||
Property and equipment, gross | 43,718 | 41,728 |
Office equipment | ||
Property, Plant and Equipment | ||
Property and equipment, gross | 6,534 | 6,330 |
Furniture and fixtures | ||
Property, Plant and Equipment | ||
Property and equipment, gross | 2,434 | 2,359 |
Leasehold improvements | ||
Property, Plant and Equipment | ||
Property and equipment, gross | 14,566 | 14,116 |
Assets under construction | ||
Property, Plant and Equipment | ||
Property and equipment, gross | $ 28,407 | $ 19,638 |
Property and Equipment, Net - Narrative (Details) - USD ($) $ in Millions |
3 Months Ended | |
---|---|---|
Mar. 31, 2025 |
Mar. 31, 2024 |
|
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 2.0 | $ 1.8 |
Intangible Assets, Net - Schedule of Carrying Amount of Intangible Assets (Details) - USD ($) $ in Thousands |
Mar. 31, 2025 |
Dec. 31, 2024 |
---|---|---|
Finite-Lived Intangible Assets | ||
Less: accumulated amortization | $ (507) | $ (162) |
Total intangibles assets, net | 12,475 | 12,373 |
Licensed IP rights | ||
Finite-Lived Intangible Assets | ||
Intangibles assets, gross | 12,935 | 12,535 |
Total intangibles assets, net | 12,475 | 12,373 |
Software licenses | ||
Finite-Lived Intangible Assets | ||
Intangibles assets, gross | $ 47 | $ 0 |
Intangible Assets, Net - Narrative (Details) - USD ($) |
3 Months Ended | |
---|---|---|
Mar. 31, 2025 |
Mar. 31, 2024 |
|
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Amortization of intangible assets | $ 285,000 | $ 0 |
Finite-lived intangible asset, expected amortization, year one | 1,100,000 | |
Finite-lived intangible asset, expected amortization, year two | 1,100,000 | |
Finite-lived intangible asset, expected amortization, year three | 1,100,000 | |
Finite-lived intangible asset, expected amortization, year four | 1,100,000 | |
Finite-lived intangible asset, expected amortization, year five | $ 1,100,000 |
Accrued Expenses and Other Liabilities (Details) - USD ($) |
Mar. 31, 2025 |
Dec. 31, 2024 |
---|---|---|
Payables and Accruals [Abstract] | ||
Compensation and benefits | $ 15,854,000 | $ 19,681,000 |
Research and development costs | 12,682,000 | 13,372,000 |
Other accrued expenditure | 7,505,000 | 6,075,000 |
Professional fees | 7,195,000 | 9,075,000 |
VAT accrual | 3,709,000 | 3,594,000 |
Other liabilities | 2,375,000 | 479,000 |
Rebates, chargebacks and returns | 339,000 | 0 |
Total accrued expenses and other liabilities | $ 49,659,000 | $ 52,276,000 |
Share-Based Compensation - Share-Based Compensation Allocation (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2025 |
Mar. 31, 2024 |
|
Share-based Compensation Arrangement by Share-based Payment Award | ||
Total share-based compensation expense | $ 2,867 | $ 2,284 |
Research and development expenses | ||
Share-based Compensation Arrangement by Share-based Payment Award | ||
Total share-based compensation expense | 998 | 450 |
Selling, general and administrative expenses | ||
Share-based Compensation Arrangement by Share-based Payment Award | ||
Total share-based compensation expense | 1,732 | 1,836 |
Cost of sales | ||
Share-based Compensation Arrangement by Share-based Payment Award | ||
Total share-based compensation expense | 146 | 0 |
Capitalized to intangibles, net / property and equipment, net | ||
Share-based Compensation Arrangement by Share-based Payment Award | ||
Total share-based compensation expense | $ (9) | $ (2) |
Share-Based Compensation - Narrative (Details) - USD ($) $ / shares in Units, $ in Millions |
3 Months Ended | |
---|---|---|
Mar. 31, 2025 |
Mar. 31, 2024 |
|
Share-based Compensation Arrangement by Share-based Payment Award | ||
Options exercised (aggregate intrinsic value) | $ 0.0 | $ 0.3 |
Share options | ||
Share-based Compensation Arrangement by Share-based Payment Award | ||
Weighted average grant date fair value (in usd per share) | $ 1.34 | $ 4.53 |
Share based compensation not yet recognized for unvested shares | $ 22.2 | |
Share based compensation not yet recognized for unvested shares vesting period (in years) | 3 years 6 months 3 days | |
Unvested restricted stock units | ||
Share-based Compensation Arrangement by Share-based Payment Award | ||
Share based compensation not yet recognized for unvested shares vesting period (in years) | 1 year 25 days | |
Share based compensation not yet recognized for unvested shares other than options | $ 0.1 |
Share-Based Compensation - Restricted Stock Units (Details) - Unvested restricted stock units |
3 Months Ended |
---|---|
Mar. 31, 2025
$ / shares
shares
| |
Number of restricted units | |
Unvested and outstanding beginning balance (in shares) | shares | 32,412 |
Vested (in shares) | shares | (16,074) |
Forfeited (in shares) | shares | (88) |
Unvested and outstanding ending balance (in shares) | shares | 16,250 |
Weighted average grant date fair value | |
Unvested and outstanding beginning balance (in usd per share) | $ / shares | $ 4.22 |
Vested (in usd per share) | $ / shares | 4.67 |
Forfeited (in usd per share) | $ / shares | 6.20 |
Unvested and outstanding ending balance (in usd per share) | $ / shares | $ 3.77 |
Liabilities Related to Future Royalties and Milestones, Net - Schedule of Changes Related to Future Royalties and Milestones (Details) - USD ($) $ in Thousands |
3 Months Ended | 12 Months Ended |
---|---|---|
Mar. 31, 2025 |
Dec. 31, 2024 |
|
Liability, Future Revenue, Rollforward [Abstract] | ||
Balance at January 1 | $ 248,100 | $ 170,899 |
Initial recognition of BioNTech liability | 0 | 38,335 |
Proceeds from Blackstone Development Payments received | 0 | 30,000 |
Interest expense accrued on liabilities related to future royalties and milestones, net | 10,137 | 39,510 |
Cumulative catch-up adjustment | 0 | (30,644) |
Total liabilities related to future royalties and milestones, net | 258,237 | 248,100 |
Liability, Future Revenue [Abstract] | ||
Current portion of liabilities related to future royalties and milestones, net | 4,800 | 3,500 |
Non-current portion of liabilities related to future royalties and milestones, net | 253,437 | 244,600 |
Total liabilities related to future royalties and milestones, net | $ 258,237 | $ 248,100 |
Leases - Lease Cost (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2025 |
Mar. 31, 2024 |
|
Lease Cost | ||
Operating lease costs | $ 2,172 | $ 2,098 |
Variable costs | 496 | 544 |
Short term lease costs | 15 | 101 |
Total lease costs | $ 2,683 | $ 2,743 |
Leases - Supplemental cash flow information (Details) - USD ($) |
3 Months Ended | |
---|---|---|
Mar. 31, 2025 |
Mar. 31, 2024 |
|
Cash paid for amounts included in the measurement of lease liabilities: | ||
Operating cash (inflows) outflows from operating leases | $ (2,163,000) | $ 1,725,000 |
Leases - Schedule of Weighted Average Remaining Lease Term and Weighted Average Discount Rate of Operating Leases (Details) |
Mar. 31, 2025 |
Mar. 31, 2024 |
---|---|---|
Leases [Abstract] | ||
Weighted-average remaining lease term - operating leases | 16 years 1 month 6 days | 16 years |
Weighted-average discount rate - operating leases | 8.16% | 7.44% |
Leases - Schedule of Maturity Payments (Details) - USD ($) $ in Thousands |
Dec. 31, 2026 |
Dec. 31, 2025 |
Mar. 31, 2025 |
---|---|---|---|
Lessor, Lease, Description [Line Items] | |||
2025 | $ 120 | ||
2026 | 8,522 | ||
2027 | 8,625 | ||
2028 | 7,884 | ||
2029 | 5,929 | ||
Thereafter | 79,890 | ||
Total lease payments | 110,970 | ||
Less: imputed interest | (53,262) | ||
Present value of lease liabilities | $ 57,708 | ||
Forecast | |||
Lessor, Lease, Description [Line Items] | |||
Incentive to Lessee | $ 700 | $ 6,300 |
Commitments and Contingencies - Narrative (Details) - USD ($) |
3 Months Ended | |
---|---|---|
Mar. 31, 2025 |
Dec. 31, 2024 |
|
Loss Contingencies [Line Items] | ||
Agreement term (in years) | 1 year | |
Loss contingency accrual | $ 0 | $ 0 |
Reduction in the value of the tax credit obtained | 18.60% | |
Reduction in the value of the tax credit obtained, net benefit | 26.97% | |
Capital Addition Purchase Commitments | ||
Loss Contingencies [Line Items] | ||
Unconditional purchase obligations for capital expenditures | $ 16,400,000 | |
Master Supply Commitments | ||
Loss Contingencies [Line Items] | ||
Unconditional purchase obligations for capital expenditures | $ 2,900,000 |
Segment Reporting - Schedule of Long-Lived Assets by Geographic Location (Details) - USD ($) $ in Thousands |
Mar. 31, 2025 |
Dec. 31, 2024 |
---|---|---|
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Total long-lived assets | $ 114,220 | $ 105,051 |
United Kingdom | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Total long-lived assets | 113,534 | 104,160 |
United States of America | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Total long-lived assets | $ 686 | $ 891 |
Related Party Transactions - Narrative (Details) |
3 Months Ended | 12 Months Ended | ||||
---|---|---|---|---|---|---|
Mar. 31, 2025
USD ($)
|
Mar. 31, 2024
USD ($)
|
Dec. 31, 2024
USD ($)
|
Feb. 28, 2024
director
|
Dec. 31, 2023
USD ($)
|
Nov. 30, 2021
director
|
|
Related Party Transaction | ||||||
Number of directors | director | 1 | 1 | ||||
Contract with customer, liability | $ 219,400,000 | |||||
Accrued interest | 7,800,000 | |||||
Carrying amount of liability | 258,237,000 | $ 248,100,000 | $ 170,899,000 | |||
Non-cash interest expense, catch-up | 0 | $ 10,900,000 | ||||
Blackstone Collaboration Agreement | ||||||
Related Party Transaction | ||||||
Carrying amount of liability | 211,600,000 | |||||
Non-cash interest expense, catch-up | 10,700,000 | |||||
BioNTech Liability | ||||||
Related Party Transaction | ||||||
Carrying amount of liability | 38,800,000 | 36,500,000 | ||||
Non-cash interest expense, catch-up | $ 2,300,000 | $ (1,800,000) | ||||
Blackstone | Autolus | ||||||
Related Party Transaction | ||||||
Ownership percentage by noncontrolling owners (in percent) | 10.00% |
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