QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |||||
For the quarterly period ended | |||||
OR | |||||
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |||||
For the transition period from to |
Not Applicable | |||||
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | ||||
(Address of principal executive offices) (Zip code) | + (Registrant’s telephone number) |
Title of each class | Trading symbol(s) | Name of each exchange on which registered | ||||||||||||
Large accelerated filer | ☐ | Accelerated filer | ☐ | |||||||||||||||||
☒ | Smaller reporting company | |||||||||||||||||||
Emerging growth company |
March 31, 2025 | December 31, 2024 | ||||||||||
ASSETS | |||||||||||
Current assets | |||||||||||
Cash and cash equivalents | $ | $ | |||||||||
Accounts receivable, net | |||||||||||
Inventory | |||||||||||
Prepaid expenses | |||||||||||
Other current assets | |||||||||||
Total current assets | |||||||||||
Property and equipment, net | |||||||||||
Operating lease right-of-use assets | |||||||||||
Other long-term assets | |||||||||||
Total assets | $ | $ | |||||||||
LIABILITIES AND SHAREHOLDERS’ (DEFICIT) EQUITY | |||||||||||
Current liabilities | |||||||||||
Accounts payable | $ | $ | |||||||||
Accrued expenses and other current liabilities | |||||||||||
Total current liabilities | |||||||||||
Deferred royalty obligation, long-term | |||||||||||
Senior secured term loans | |||||||||||
Operating lease liabilities, long-term | |||||||||||
Other long-term liabilities | |||||||||||
Total liabilities | |||||||||||
Commitments and contingencies (See Note 12) | |||||||||||
Shareholders’ (deficit) equity | |||||||||||
Common shares, at CHF | |||||||||||
Issued shares: | |||||||||||
Additional paid-in capital | |||||||||||
Treasury shares | ( | ( | |||||||||
At March 31, 2025: | |||||||||||
Accumulated other comprehensive loss | ( | ( | |||||||||
Accumulated deficit | ( | ( | |||||||||
Total shareholders’ (deficit) equity | ( | ( | |||||||||
Total liabilities and shareholders’ (deficit) equity | $ | $ |
ADC Therapeutics SA |
For the Three Months Ended March 31, | |||||||||||
2025 | 2024 | ||||||||||
Revenue | |||||||||||
Product revenues, net | $ | $ | |||||||||
License revenues and royalties | |||||||||||
Total revenue, net | |||||||||||
Operating expense | |||||||||||
Cost of product sales | ( | ( | |||||||||
Research and development | ( | ( | |||||||||
Selling and marketing | ( | ( | |||||||||
General and administrative | ( | ( | |||||||||
Total operating expense | ( | ( | |||||||||
Loss from operations | ( | ( | |||||||||
Other income (expense) | |||||||||||
Interest income | |||||||||||
Interest expense | ( | ( | |||||||||
Other, net | ( | ||||||||||
Total other expense, net | ( | ( | |||||||||
Loss before income taxes | ( | ( | |||||||||
Income tax expense | ( | ( | |||||||||
Loss before equity in net losses of joint venture | ( | ( | |||||||||
Equity in net losses of joint venture | ( | ||||||||||
Net loss | $ | ( | $ | ( | |||||||
Net loss per share | |||||||||||
Net loss per share, basic and diluted | $ | ( | $ | ( | |||||||
Weighted average shares outstanding, basic and diluted |
ADC Therapeutics SA |
For the Three Months Ended March 31, | |||||||||||
2025 | 2024 | ||||||||||
Net loss | $ | ( | $ | ( | |||||||
Other comprehensive (loss) income: | |||||||||||
Remeasurement of defined benefit pension liability | ( | ||||||||||
Foreign currency translation adjustment | ( | ||||||||||
Other comprehensive income (loss) before share of other comprehensive loss in joint venture | ( | ||||||||||
Share of other comprehensive loss in joint venture | ( | ||||||||||
Other comprehensive income (loss) | ( | ||||||||||
Total comprehensive loss | $ | ( | $ | ( |
ADC Therapeutics SA |
(in thousands, except share amounts) | Number of shares | Common shares, par value | Additional paid-in capital | Number of shares (held or received)/delivered | Treasury shares | Accumulated other comprehensive (loss) income | Accumulated deficit | Total | ||||||||||||||||||||||||||||||||||||||||||
January 1, 2025 | $ | $ | ( | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||||||||||||||||||||||||||
Loss for the period | — | — | — | — | — | — | ( | ( | ||||||||||||||||||||||||||||||||||||||||||
Remeasurement of defined benefit pension liability | — | — | — | — | — | ( | — | ( | ||||||||||||||||||||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||
Other comprehensive income before share of other comprehensive loss in joint venture | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||
Share of other comprehensive loss in joint venture | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||
Total other comprehensive income | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||
Total comprehensive income (loss) for the period | — | — | — | — | — | ( | ( | |||||||||||||||||||||||||||||||||||||||||||
Vestings of RSUs | ( | — | — | |||||||||||||||||||||||||||||||||||||||||||||||
Issuance of shares, 2022 Employee Stock Purchase Plan | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||
Share-based compensation expense | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||
— | — | |||||||||||||||||||||||||||||||||||||||||||||||||
March 31, 2025 | $ | $ | ( | $ | ( | $ | ( | $ | ( | $ | ( |
(in thousands, except share amounts) | Number of shares | Common shares, par value | Additional paid-in capital | Number of shares (held or received)/delivered | Treasury shares | Accumulated other comprehensive (loss) income | Accumulated deficit | Total | ||||||||||||||||||||||||||||||||||||||||||
January 1, 2024 | $ | $ | ( | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||||||||||||||||||||||||||
Loss for the period | — | — | — | — | — | — | ( | ( | ||||||||||||||||||||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | — | — | ( | — | ( | ||||||||||||||||||||||||||||||||||||||||||
Other comprehensive loss before share of other comprehensive loss in joint venture | — | — | — | — | — | ( | — | ( | ||||||||||||||||||||||||||||||||||||||||||
Share of other comprehensive loss in joint venture | — | — | — | — | — | ( | — | ( | ||||||||||||||||||||||||||||||||||||||||||
Total other comprehensive loss | — | — | — | — | — | ( | — | ( | ||||||||||||||||||||||||||||||||||||||||||
Total comprehensive loss for the period | — | — | — | — | — | ( | ( | ( | ||||||||||||||||||||||||||||||||||||||||||
Vestings of RSUs | — | — | ( | — | — | |||||||||||||||||||||||||||||||||||||||||||||
Exercise of options | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||
Issuance of shares, 2022 Employee Stock Purchase Plan | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||
Share-based compensation expense | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||
— | — | |||||||||||||||||||||||||||||||||||||||||||||||||
March 31, 2024 | $ | $ | ( | $ | ( | $ | ( | $ | ( | $ | ( |
ADC Therapeutics SA |
For the Three Months Ended March 31, | |||||||||||
2025 | 2024 | ||||||||||
Cash flows used in operating activities | |||||||||||
Net loss | $ | ( | $ | ( | |||||||
Adjustments to reconcile net loss to net cash used in operations: | |||||||||||
Share-based compensation expense | |||||||||||
Accretion expense of deferred royalty obligation | |||||||||||
Cumulative catch-up adjustment, deferred royalty obligation | ( | ( | |||||||||
Write-downs of inventory | |||||||||||
Depreciation | |||||||||||
Amortization of operating lease right-of-use assets | |||||||||||
Share of results in joint venture | |||||||||||
Warrant obligations, decrease in fair value | |||||||||||
Amortization of debt discount, senior secured term loan | |||||||||||
Other | ( | ||||||||||
Changes in operating assets and liabilities: | |||||||||||
Accounts receivable, net | ( | ||||||||||
Inventory | ( | ( | |||||||||
Prepaid expenses and other current assets | ( | ||||||||||
Other long-term assets | ( | ||||||||||
Accounts payable | ( | ( | |||||||||
Accrued expenses and other current liabilities | ( | ( | |||||||||
Operating lease liabilities | ( | ( | |||||||||
Other long-term liabilities | ( | ||||||||||
Net cash used in operating activities | ( | ( | |||||||||
Cash flows used in investing activities | |||||||||||
Payment for purchases of property and equipment | ( | ( | |||||||||
Net cash used in investing activities | ( | ( | |||||||||
Cash flows provided by financing activities | |||||||||||
Proceeds from share issuance under stock purchase plan | |||||||||||
Proceeds from the exercise of stock options | |||||||||||
Net cash provided by financing activities | |||||||||||
Net decrease in cash and cash equivalents | ( | ( | |||||||||
Exchange gains (losses) on cash and cash equivalents | ( | ||||||||||
Cash and cash equivalents at beginning of period | |||||||||||
Cash and cash equivalents at end of period | $ | $ | |||||||||
Supplemental Cash Flow Information: | |||||||||||
Interest paid | $ | $ | |||||||||
Interest received | |||||||||||
Payments made under royalty financing transaction | |||||||||||
Supplemental Non-Cash Investing and Financing Activities: | |||||||||||
Capital expenditures recorded in Accounts payable and other current liabilities | |||||||||||
ADC Therapeutics SA | ||
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS | ||
(Unaudited) | ||
(in thousands, except per share amounts) |
(in thousands) | March 31, 2025 | December 31, 2024 | ||||||||||||
Work in progress | $ | $ | ||||||||||||
Finished goods | ||||||||||||||
Total inventory, net | $ | $ |
(in thousands) | March 31, 2025 | December 31, 2024 | ||||||||||||
Leasehold improvements | $ | $ | ||||||||||||
Laboratory equipment | ||||||||||||||
Office equipment | ||||||||||||||
Hardware and computer software | ||||||||||||||
Less: accumulated depreciation | ( | ( | ||||||||||||
Property and equipment, net | $ | $ |
(in thousands) | March 31, 2025 | December 31, 2024 | ||||||||||||
Accrued R&D costs | $ | $ | ||||||||||||
Accrued payroll and benefits | ||||||||||||||
Gross-to-net sales adjustments, short-term | ||||||||||||||
Operating lease liabilities, short-term | ||||||||||||||
Other | ||||||||||||||
$ | $ |
Three Months Ended March 31, | ||||||||||||||
2025 | 2024 | |||||||||||||
Contractual interest expense | $ | $ | ||||||||||||
Amortization of debt discount | ||||||||||||||
Total | $ | $ |
2025 (remainder) | $ | |||||||
2026 (commencing third quarter) | ||||||||
2027 | ||||||||
2028 | ||||||||
2029 | ||||||||
Total | $ |
As of | As of | ||||||||||
March 31, 2025 | December 31, 2024 | ||||||||||
Exercise price in $ | |||||||||||
Share price in $ | |||||||||||
Risk-free interest rate | % | % | |||||||||
Expected volatility | % | % | |||||||||
Expected term (years) | 0.14 years | 0.39 years | |||||||||
Dividend yield | |||||||||||
Black-Scholes value in $ |
(in thousands) | ||||||||
Liability balance at January 1, 2024 | $ | |||||||
Less: royalty payments | ||||||||
Plus: interest expense | ||||||||
Less: cumulative catch-up adjustment, Other, net | ||||||||
Liability balance at December 31, 2024 | ||||||||
Less: royalty payments | ||||||||
Plus: interest expense | ||||||||
Less: cumulative catch-up adjustment, Other, net | ||||||||
Liability balance at March 31, 2025 | $ |
Three Months Ended March 31, | ||||||||||||||
(in thousands) | 2025 | 2024 | ||||||||||||
Net periodic benefit cost: | ||||||||||||||
Service cost | $ | $ | ||||||||||||
Interest cost | ||||||||||||||
Expected return on plan assets | ( | ( | ||||||||||||
Amortization of prior service cost | ( | ( | ||||||||||||
Amortization of actuarial losses | ||||||||||||||
Net periodic benefit cost | $ | $ |
Three Months Ended March 31, | ||||||||||||||
(in thousands) | 2025 | 2024 | ||||||||||||
Types of goods and services | ||||||||||||||
Product revenues, net | $ | $ | ||||||||||||
License revenues | ||||||||||||||
Royalties | ||||||||||||||
Total revenue | $ | $ | ||||||||||||
Customer Location | ||||||||||||||
U.S. | $ | $ | ||||||||||||
EMEA(1) | ||||||||||||||
Total revenue | $ | $ |
(in thousands) | Discarded Drug Rebate | Other Adjustments | Total | |||||||||||||||||
Balance as of January 1, 2024 | $ | $ | $ | |||||||||||||||||
GTN accruals for current period | ||||||||||||||||||||
Prior period adjustments | ( | ( | ( | |||||||||||||||||
Credits, payments and reclassifications | ( | ( | ||||||||||||||||||
Balance as of March 31, 2024 | $ | $ | $ | |||||||||||||||||
Balance as of January 1, 2025 | $ | $ | $ | |||||||||||||||||
GTN accruals for current period | ||||||||||||||||||||
Prior period adjustments | ( | ( | ( | |||||||||||||||||
Credits, payments and reclassifications | ( | ( | ( | |||||||||||||||||
Balance as of March 31, 2025 | $ | $ | $ |
(in thousands) | March 31, 2025 | December 31, 2024 | ||||||||||||
Accounts receivable, net | $ | $ | ||||||||||||
Other current and non-current liabilities | ||||||||||||||
$ | $ |
Three Months Ended March 31, | ||||||||||||||
2025 | 2024 | |||||||||||||
McKesson | % | % | ||||||||||||
AmerisourceBergen Corporation(1) | % | % | ||||||||||||
Cardinal Health | % | % |
Three Months Ended March 31, | ||||||||||||||
(in thousands) | 2025 | 2024 | ||||||||||||
Deferred royalty obligation interest expense | $ | $ | ||||||||||||
Effective interest expense on senior secured term loan facility | ||||||||||||||
Interest expense | $ | $ |
Three Months Ended March 31, | ||||||||||||||
(in thousands) | 2025 | 2024 | ||||||||||||
Deerfield warrant obligation, change in fair value expense | $ | $ | ( | |||||||||||
Cumulative catch-up adjustment, deferred royalty obligation | ||||||||||||||
Exchange differences loss | ( | ( | ||||||||||||
R&D tax credit gain | ||||||||||||||
Other, net | $ | $ | ( |
Weighted average strike price per share (in $ per share) | Number of awards | Weighted average remaining life in years | Aggregate Intrinsic Value (in $ thousands) | |||||||||||||||||||||||
Outstanding as of December 31, 2024 | $ | $ | — | |||||||||||||||||||||||
Granted | ||||||||||||||||||||||||||
Forfeited | ( | |||||||||||||||||||||||||
Expired | ( | |||||||||||||||||||||||||
Outstanding as of March 31, 2025 | $ | $ | — |
Three Months Ended March 31, | ||||||||||||||
2025 | 2024 | |||||||||||||
Share price, in $ | ||||||||||||||
Strike price, in $ | ||||||||||||||
Expected volatility, in % | ||||||||||||||
Award life, in years | ||||||||||||||
Expected dividends | ||||||||||||||
Risk-free interest rate, in % |
Number of awards | Weighted average grant date fair value (in $ per share) | ||||||||||
December 31, 2024 | $ | ||||||||||
Granted | |||||||||||
Vested | ( | ||||||||||
Forfeited | ( | ||||||||||
March 31, 2025 (1) | $ |
Three Months Ended March 31, | ||||||||||||||
(in thousands, except share and per share amounts) | 2025 | 2024 | ||||||||||||
Net loss | $ | ( | $ | ( | ||||||||||
Weighted average number of shares outstanding | ||||||||||||||
Basic and diluted loss per share | $ | ( | $ | ( |
Three Months Ended March 31, | ||||||||||||||
2025 | 2024 | |||||||||||||
2019 Equity Incentive Plan - Share Options | ||||||||||||||
Inducement Plan - Share Options | ||||||||||||||
2019 Equity Incentive Plan - RSUs | ||||||||||||||
Conditional Share Capital Plan - RSUs | ||||||||||||||
Outstanding warrants | ||||||||||||||
Three Months Ended March 31, | ||||||||||||||
2025 | 2024 | |||||||||||||
Total revenues, net | $ | $ | ||||||||||||
Significant operating expenses: | ||||||||||||||
Cost of product sales | ( | ( | ||||||||||||
Research and development(1) | ( | ( | ||||||||||||
Selling and marketing(1) | ( | ( | ||||||||||||
General and administrative(1) | ( | ( | ||||||||||||
Share-based compensation | ( | ( | ||||||||||||
Total operating expenses | ( | ( | ||||||||||||
Loss from operations | ( | ( | ||||||||||||
Other segment items(2) | ( | ( | ||||||||||||
Net loss | $ | ( | $ | ( |
Three Months Ended March 31, | |||||||||||||||||||||||
(in thousands, except percentages and per share) | 2025 | 2024 | Change | % Change | |||||||||||||||||||
Revenue | |||||||||||||||||||||||
Product revenues, net | $ | 17,404 | $ | 17,848 | $ | (444) | (2.5) | % | |||||||||||||||
License revenues and royalties | 5,629 | 205 | 5,424 | N/A | |||||||||||||||||||
Total revenue, net | 23,033 | 18,053 | 4,980 | 27.6 | % | ||||||||||||||||||
Operating expense | |||||||||||||||||||||||
Cost of product sales | (2,061) | (2,510) | 449 | (17.9) | % | ||||||||||||||||||
Research and development | (28,928) | (25,735) | (3,193) | 12.4 | % | ||||||||||||||||||
Selling and marketing | (10,553) | (11,390) | 837 | (7.3) | % | ||||||||||||||||||
General and administrative | (9,955) | (12,031) | 2,076 | (17.3) | % | ||||||||||||||||||
Total operating expense | (51,497) | (51,666) | 169 | (0.3) | % | ||||||||||||||||||
Loss from operations | (28,464) | (33,613) | 5,149 | (15.3) | % | ||||||||||||||||||
Other income (expense) | |||||||||||||||||||||||
Interest income | 2,054 | 2,948 | (894) | (30.3) | % | ||||||||||||||||||
Interest expense | (12,230) | (12,496) | 266 | (2.1) | % | ||||||||||||||||||
Other, net | 203 | (2,595) | 2,798 | (107.8) | % | ||||||||||||||||||
Total other expense, net | (9,973) | (12,143) | 2,170 | (17.9) | % | ||||||||||||||||||
Loss before income taxes | (38,437) | (45,756) | 7,319 | (16.0) | % | ||||||||||||||||||
Income tax expense | (165) | (163) | (2) | 1.2 | % | ||||||||||||||||||
Loss before equity in net losses of joint venture | (38,602) | (45,919) | 7,317 | (15.9) | % | ||||||||||||||||||
Equity in net losses of joint venture | — | (687) | 687 | (100.0) | % | ||||||||||||||||||
Net loss | $ | (38,602) | $ | (46,606) | $ | 8,004 | (17.2) | % | |||||||||||||||
Net loss per share, basic and diluted | $ | (0.36) | $ | (0.56) | $ | 0.20 | (35.7) | % |
Three Months Ended March 31, | ||||||||||||||
(in thousands) | 2025 | 2024 | Change | |||||||||||
ZYNLONTA | $ | 14,370 | $ | 14,999 | $ | (629) | ||||||||
ADCT-601(1) | 2,035 | 3,324 | (1,289) | |||||||||||
Preclinical product candidates and research pipeline | 7,762 | 3,691 | 4,071 | |||||||||||
Other discontinued programs(2) | 1,052 | 1,984 | (932) | |||||||||||
Not allocated to specific programs(3) | 2,717 | 2,287 | 430 | |||||||||||
Share-based compensation expense (reversal) | 992 | (550) | 1,542 | |||||||||||
Research and development expenses | $ | 28,928 | $ | 25,735 | $ | 3,193 |
Three Months Ended March 31, | |||||||||||||||||
(in thousands) | 2025 | 2024 | Change | ||||||||||||||
External costs and overhead | $ | 4,627 | $ | 5,812 | $ | (1,185) | |||||||||||
Employee expenses(1) | 5,690 | 6,218 | (528) | ||||||||||||||
Share-based compensation expense (reversal) | 236 | (640) | 876 | ||||||||||||||
Selling and marketing expenses | $ | 10,553 | $ | 11,390 | $ | (837) |
Three Months Ended March 31, | |||||||||||||||||
(in thousands) | 2025 | 2024 | Change | ||||||||||||||
External costs and overhead | $ | 3,712 | $ | 5,877 | $ | (2,165) | |||||||||||
Employee expenses(1) | 5,050 | 4,806 | 244 | ||||||||||||||
Share-based compensation expense | 1,193 | 1,348 | (155) | ||||||||||||||
General and administrative expenses | $ | 9,955 | $ | 12,031 | $ | (2,076) |
Three Months Ended March 31, | |||||||||||||||||
(in thousands) | 2025 | 2024 | Change | ||||||||||||||
Deerfield warrant obligation, change in fair value expense | — | $ | (3,068) | $ | 3,068 | ||||||||||||
Cumulative catch-up adjustment, deferred royalty obligation | 12 | 263 | (251) | ||||||||||||||
Exchange differences loss | (90) | (37) | (53) | ||||||||||||||
R&D tax credit gain | 281 | 247 | 34 | ||||||||||||||
Total | $ | 203 | $ | (2,595) | $ | 2,798 |
Three Months Ended March 31, | |||||||||||||||||
(in thousands) | 2025 | 2024 | Change | ||||||||||||||
Share of Overland ADCT BioPharma net loss | $ | — | $ | (687) | $ | 687 |
Three Months Ended March 31, | |||||||||||||||||
(in thousands) | 2025 | 2024 | Change | ||||||||||||||
Net cash (used in) provided by: | |||||||||||||||||
Operating activities | $ | (56,334) | $ | (44,095) | $ | (12,239) | |||||||||||
Investing activities | (264) | (531) | 267 | ||||||||||||||
Financing activities | 271 | 356 | (85) | ||||||||||||||
Net change in cash and cash equivalents | $ | (56,327) | $ | (44,270) | $ | (12,057) |
Incorporation by Reference | ||||||||||||||||||||
Exhibit No. | Description | Form | File No. | Exhibit No. | Filing Date | |||||||||||||||
3.1 | 10-K | 001-39071 | 3.1 | March 27, 2025 | ||||||||||||||||
31.1* | ||||||||||||||||||||
31.2* | ||||||||||||||||||||
32.1* | ||||||||||||||||||||
32.2* | ||||||||||||||||||||
101.INS | XBRL Taxonomy Instance Document | |||||||||||||||||||
101.SCH | XBRL Taxonomy Extension Schema Document | |||||||||||||||||||
101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document | |||||||||||||||||||
101.DEF | XBRL Taxonomy Extension Definition Linkbase Document | |||||||||||||||||||
101.LAB | XBRL Taxonomy Extension Label Linkbase Document | |||||||||||||||||||
101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document | |||||||||||||||||||
104 | Cover Page Interactive Data File (embedded with the Inline XBRL document and contained in Exhibit 101) |
ADC Therapeutics SA | |||||||||||
/s/ Ameet Mallik | |||||||||||
Date: May 14, 2025 | By: | Ameet Mallik | |||||||||
Chief Executive Officer | |||||||||||
(Principal Executive Officer) | |||||||||||
/s/ Jose Carmona | |||||||||||
Date: May 14, 2025 | By: | Jose Carmona | |||||||||
Chief Financial Officer | |||||||||||
(Principal Financial Officer) | |||||||||||
/s/ Lisa Kallebo | |||||||||||
Date: May 14, 2025 | By: | Lisa Kallebo | |||||||||
Corporate Controller and Chief Accounting Officer | |||||||||||
(Principal Accounting Officer) | |||||||||||
Date: | May 14, 2025 | Ameet Mallik Chief Executive Officer |
Date: | May 14, 2025 | /s/ Jose Carmona Jose Carmona Chief Financial Officer |
Date: | May 14, 2025 | /s/ Ameet Mallik Ameet Mallik Chief Executive Officer |
Date: | May 14, 2025 | /s/ Jose Carmona Jose Carmona Chief Financial Officer |
QO&5P!_LVMNI_,1YK@_%GQ#\3^.IED\0:]J&KE?NK=7#
M.J_[JYP/P%9<>AZE(X1-/NG;^ZL+$_RKI-#^#?CKQ)/'%IOA'6;@R' ?[%(B
M?B[ *![DTXTL)A_?C&,?.R1$L1F.-7LY3G/RO)_@<=6WX-\%ZSX_\06VBZ#8
MRZAJ%P<+'&.%'=F/15'
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - SFr / shares |
Mar. 31, 2025 |
Dec. 31, 2024 |
---|---|---|
Statement of Financial Position [Abstract] | ||
Common shares, par value (in CHF per share) | SFr 0.08 | SFr 0.08 |
Common shares issued (in shares) | 101,759,684 | 101,606,376 |
Common shares outstanding (in shares) | 99,178,286 | 98,861,402 |
Treasury shares (in shares) | 2,581,398 | 2,744,974 |
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2025 |
Mar. 31, 2024 |
|
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (38,602) | $ (46,606) |
Other comprehensive (loss) income: | ||
Remeasurement of defined benefit pension liability | (42) | 0 |
Foreign currency translation adjustment | 371 | (78) |
Other comprehensive income (loss) before share of other comprehensive loss in joint venture | 329 | (78) |
Share of other comprehensive loss in joint venture | 0 | (30) |
Other comprehensive income (loss) | 329 | (108) |
Total comprehensive loss | $ (38,273) | $ (46,714) |
Description of Business and Organization |
3 Months Ended |
---|---|
Mar. 31, 2025 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business and Organization | Description of Business and Organization ADC Therapeutics is a commercial-stage global pioneer in the field of antibody drug conjugates (“ADCs”) committed to advancing its proprietary ADC technology platform to transform the cancer treatment paradigm for patients with hematologic malignancies and solid tumors. Since its inception, the Company has devoted its resources to developing a validated and differentiated technology platform with multiple payloads, linkers and conjugation chemistry, enabling the design of next-generation potent ADCs with an enhanced therapeutic index. The Company generates sales from its flagship product, ZYNLONTA, which was granted accelerated approval by the Food and Drug Administration (“FDA”) in the U.S. for the treatment of relapsed or refractory diffuse large B-cell lymphoma (“DLBCL”) in the 3L setting and has also been granted conditional approval from the European Commission, conditional approval from the China National Medical Products Administration and conditional approval by Health Canada. Additionally, the Company is seeking to expand ZYNLONTA into new indications and earlier lines of therapy while pursuing our early-stage solid tumor programs. The Company was incorporated on June 6, 2011 under the laws of Switzerland, with its registered office located at Route de la Corniche 3B, 1066 Epalinges, Switzerland. The Company has two wholly-owned subsidiaries: ADC Therapeutics America, Inc. (“ADCT America”), which was incorporated in Delaware, USA on December 10, 2014 and ADC Therapeutics (UK) Ltd (“ADCT UK”), incorporated in England on December 12, 2014. The Company and its two subsidiaries form the ADCT Group (the “Group”). All references to “ADC Therapeutics,” “the Company", “we,” “us,” and “our” refer to ADC Therapeutics SA and its consolidated subsidiaries unless otherwise indicated.
|
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 preparation and principles of consolidation These accompanying unaudited condensed consolidated financial statements, which include the accounts of the Company and its wholly-owned subsidiaries, have been prepared following the requirements of the U.S. Securities and Exchange Commission for interim reporting. As permitted under those rules, certain footnotes and other financial information that are normally required by U.S. generally accepted accounting principles, or U.S. GAAP, can be condensed or omitted. All intercompany transactions and balances have been eliminated in consolidation. The information included in this Quarterly Report on Form 10‑Q should be read in conjunction with our annual audited consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10‑K for the year ended December 31, 2024. In the opinion of management, these condensed consolidated financial statements have been prepared on the same basis as the annual audited consolidated financial statements and include all adjustments, consisting only of normal recurring adjustments, considered necessary for the fair statement of our financial position and operating results. The results for the three months ended March 31, 2025 are not necessarily indicative of the results to be expected for the year ending December 31, 2025, for any other interim period or for any future period. The Company’s significant accounting policies have not changed substantially from those previously described in the Company’s Annual Report on Form 10‑K for the year ended December 31, 2024. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures in the consolidated financial statements and accompanying notes. Management bases its estimates on historical experience and on assumptions believed to be reasonable under the circumstances. Actual results could differ materially from those estimates. Recent Accounting Pronouncements Issued but not yet adopted In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The ASU requires the annual financial statements to include consistent categories and greater disaggregation of information in the rate reconciliation, and income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for the Company’s annual reporting periods beginning in January 2025. Adoption is either with a prospective method or a fully retrospective method of transition. Early adoption is permitted. The Company is currently evaluating the effect that adoption of ASU 2023-09 will have on its consolidated financial statements. The Company does not anticipate adoption of this standard will have a material impact on our financial results but may result in enhanced or expanded 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 Disclosure. The ASU requires disaggregation, in the notes to the financial statements, of certain cost and expense captions presented on the face of the Company’s interim and annual financial statements. ASU 2023-09 is effective for fiscal years beginning in January 2027 and interim periods beginning January 2028, with early adoption permitted. Adoption may be applied prospectively or retrospectively. The Company is currently evaluating the effect that adoption of ASU 2024-03 will have on its consolidated financial statements.
|
Fair value measurements |
3 Months Ended |
---|---|
Mar. 31, 2025 | |
Fair Value Disclosures [Abstract] | |
Fair value measurements | Fair value measurements The carrying amount of Cash and cash equivalents, Accounts Receivable, net and Accounts payable is a reasonable approximation of fair value due to the short-term nature of these assets and liabilities. Financial liabilities that are not measured at fair value on a recurring basis include our senior secured term loan and deferred royalty financing obligation. The carrying value of our senior secured term loan approximates fair value as these borrowings are based on variable market rates. The fair value of our deferred royalty obligation was $312.0 million as of both March 31, 2025 and December 31, 2024 and is based on our current estimates of future royalties expected to be paid over the estimated life of the royalty purchase agreement which are level 3 inputs. The Deerfield warrants are measured at fair value on a recurring basis and are classified as Level 2. As of March 31, 2025 and December 31, 2024 the value of the Deerfield warrants was $0. Fair values must be estimated at the end of each reporting period with regard to the Deerfield warrants. The approach to valuation follows the fair value principle, and the key input factors are described for the Deerfield warrants in Note 9, "Deerfield warrants." A Black-Scholes model was used to calculate the fair values. There were no transfers between the respective levels during the period.
|
Inventory |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2025 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory | Inventory As of March 31, 2025 and December 31, 2024 inventory consisted of the following:
|
Property and equipment |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2025 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property, Plant and Equipment [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property and equipment | Property and equipment Property and equipment as of March 31, 2025 and December 31, 2024 consisted of the following:
|
Income taxes |
3 Months Ended |
---|---|
Mar. 31, 2025 | |
Income Tax Disclosure [Abstract] | |
Income taxes | Income taxes Income tax expense for the three months ended March 31, 2025 was $0.2 million relative to loss before income taxes of $38.4 million. The income tax expense for the three months ended March 31, 2024 was $0.2 million relative to loss before income taxes of $45.8 million. The expense for the three months ended March 31, 2025 and 2024 was the result of income generated by our UK operations for which tax expense has been recognized based on a full year estimated income tax liability, and the inability to recognize benefit on losses in the U.S. and Switzerland. We retain a full valuation allowance against all deferred tax assets, and each reporting period, we evaluate the need for a valuation allowance on our deferred tax assets by jurisdiction and adjust our estimates as more information becomes available.
|
Accrued expenses and other current liabilities |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2025 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accrued expenses and other current liabilities | Accrued expenses and other current liabilities Accrued expenses and other current liabilities consist of the following:
|
Senior secured term loan facility |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2025 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Debt Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Senior secured term loan facility | Senior secured term loan facility On August 15, 2022, the Company, ADCT UK and ADCT America entered into the Loan Agreement, pursuant to which the Company may borrow up to $175.0 million principal amount of secured term loans, including (i) a First Tranche and (ii) Future Tranches. On August 15, 2022, the Company drew down $120.0 million principal amount of term loans under the Loan Agreement. On August 15, 2022, the Company also issued to the lenders under the Loan Agreement warrants to purchase an aggregate of 527,295 common shares, which warrants have an exercise price of $8.30 per share. Each warrant is exercisable, on a cash or a cashless basis, at the option of the holder at any time on or prior to August 15, 2032. The warrants are freestanding financial instruments that are indexed to the Company’s common stock and meet all other conditions for equity classification under ASC 480 and ASC 815. Accordingly, these warrants are recognized in equity and accounted for as a component of additional paid-in capital at the time of issuance. On August 15, 2022, the Company also entered into the Share Purchase Agreement with the lenders under the Loan Agreement to purchase 733,568 common shares of the Company. For the three months ended March 31, 2025 and 2024, the Company recorded interest expense on the senior secured term loan in the amount of $3,785 and $4,403, respectively, which was recorded in interest expense in the unaudited condensed consolidated statements of operations. The effective interest rate (“EIR”) at March 31, 2025 was 16.15%. The following table provides a summary of the interest expense for the Company’s senior secured term loan for the three months ended March 31, 2025 and 2024:
The amount at which the senior secured term loan is presented as a liability in the unaudited condensed consolidated balance sheets represents the net present value of all future cash outflows associated with the loan discounted at the EIR. The carrying value of the senior secured term loan is $113.8 million and $113.6 million as of March 31, 2025 and December 31, 2024, respectively. Contractual payments due under our senior secured term loans, including exit fees are as follows (in thousands):
|
Deerfield warrants |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2025 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other Liabilities Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deerfield warrants | Deerfield warrants Pursuant to the Exchange Agreement with Deerfield entered into on August 15, 2022, the Company issued warrants to purchase an aggregate of 4,412,840 common shares. The warrants consist of warrants to purchase an aggregate of 2,631,578 common shares at an exercise price of $24.70 per share and warrants to purchase an aggregate of 1,781,262 common shares at an exercise price of $28.07 per share. Each warrant is exercisable, on a cash or a cashless basis, at the option of the holder, at any time on or prior to May 19, 2025. The warrant obligation, which is included in other long-term liabilities in the unaudited condensed consolidated balance sheets, is remeasured to fair value at the end of each reporting period. Changes in the fair value losses of the warrant obligation at the end of each period are recorded in the unaudited condensed consolidated statements of operations. During the three months ended March 31, 2025 and 2024, the Company recognized expense of $0 and $3,068, respectively, as a result of changes in the fair value of the warrant obligation. This amount was recorded to Other, net in the unaudited condensed consolidated statements of operations. The fair value of the warrant obligation as of March 31, 2025 and December 31, 2024 was $0. See Note 14, "Other income (expense)" for further information. The Company valued the Deerfield warrant obligation using a Black-Scholes option-pricing model. Key inputs for the valuation of the warrant obligation as of March 31, 2025 and December 31, 2024 were as follows:
|
Deferred royalty obligation |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2025 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other Liabilities Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deferred royalty obligation | Deferred royalty obligation On August 25, 2021, the Company entered into a royalty purchase agreement with certain entities managed by HCR for up to $325.0 million. Under the terms of the agreement, the Company received gross proceeds of $225.0 million upon closing (the “First Investment Amount”) and received an additional $75.0 million during the year ended December 31, 2023 upon the first commercial sale of ZYNLONTA in the United Kingdom or any European Union country (the “Second Investment Amount”) and together with the First Investment Amount, the “Investment Amount”). The table below provides a rollforward of the Company’s debt obligation relating to the royalty purchase agreement.
|
Pension and post-retirement benefit obligations |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2025 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Retirement Benefits [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Pension and post-retirement benefit obligations | Pension and post-retirement benefit obligations The pension plan for Swiss employees is a defined benefit pension plan. The Company contracted with the Swiss Life Collective BVG Foundation based in Zurich for the provision of occupational benefits. All benefits in accordance with the regulations are reinsured in their entirety with Swiss Life SA within the framework of the corresponding contract. This pension solution fully reinsures the risks of disability, death and longevity with Swiss Life. Swiss Life invests the vested pension capital and provides a 100% capital and interest guarantee. The pension plan is entitled to an annual bonus from Swiss Life comprising the effective savings, risk and cost results. Although, as is the case with many Swiss pension plans, the amount of ultimate pension benefit is not defined, certain legal obligations of the plan create constructive obligations on the employer to pay further contributions to fund an eventual deficit; this results in the plan nevertheless being accounted for as a defined benefit plan. The net periodic benefit cost for the three months ended March 31, 2025 and 2024 is as follows:
The components of net periodic benefit cost are included in operating expense on the unaudited condensed consolidated statements of operations.
|
Commitments and contingencies |
3 Months Ended |
---|---|
Mar. 31, 2025 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and contingencies | Commitments and contingencies Manufacturing Commitments Some of our inventory components require long lead times to manufacture. Therefore, we make long-term investments in our supply chain in order to ensure we have enough drug product to meet current and future revenue forecasts. Third party manufacturing agreements include non-cancelable obligations related to the supply of ZYNLONTA and the company’s product candidates. There have been no material changes related to our non-cancelable obligations under these arrangements as disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024. Contingent liabilities From time to time, we may be involved in various legal matters generally incidental to our business. Although the results of litigation and claims cannot be predicted with certainty, after discussion with legal counsel, we are not aware of any matters for which the likelihood of a loss is probable and reasonably estimable and which could have a material impact on our consolidated financial condition, liquidity, or results of operations.
|
Revenue |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2025 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue from Contract with Customer [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue | Revenue The table below provides a disaggregation of revenues by type and customer location for the three months ended March 31, 2025 and 2024:
(1) Europe, the Middle East and Africa Product revenues, net The table below provides a rollforward of the Company’s accruals related to the gross-to-net (“GTN”) sales adjustments for the three months ended March 31, 2025 and March 31, 2024:
The table below provides the classification of the accruals related to the GTN sales adjustment included in the Company’s unaudited condensed consolidated balance sheets as of March 31, 2025 and December 31, 2024.
Customers from which we derive more than 10% of our total product revenues for the three months ended March 31, 2025 and 2024 are as follows:
(1) AmerisourceBergen also operates under the name Cencora License revenues On July 8, 2022, the Company entered into exclusive license agreement with Sobi for the development and commercialization of ZYNLONTA for all hematologic and solid tumor indications outside of the U.S., greater China, Singapore and Japan. Under the terms of the agreement, the Company is eligible to receive regulatory and net sales-based milestones. In March 2025, the Company recognized $5.0 million in license revenue upon ZYNLONTA’s conditional approval by Health Canada for the treatment of relapsed or refractory DLBCL after two or more lines of systemic therapy.
|
Other income (expense) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2025 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other Income and Expenses [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other income (expense) | Other income (expense) Interest Income Interest income includes interest received from banks on our cash balances. Interest income was $2.1 million and $2.9 million for the three months ended March 31, 2025 and 2024, respectively. Interest Expense The components of Interest expense for the three months ended March 31, 2025 and 2024 are as follows:
Other, net The components of Other, net for the three months ended March 31, 2025 and 2024 are as follows:
|
Share-based compensation |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2025 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-Based Payment Arrangement [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-based compensation | Share-based compensation The Company has adopted various share-based compensation incentive plans. Under these plans the Company may at its discretion grant to the plan participants, such as directors, certain employees, and service providers awards in the form of restricted shares and restricted share units (“RSUs”), share options, share appreciation rights, performance awards and other share-based awards. The 2019 Equity Incentive Plan was adopted in November 2019 while the Conditional Share Capital Plan and the Inducement Plan were adopted in December 2023. 2019 Equity Incentive Plan In November 2019, the Company adopted the 2019 Equity Incentive Plan. Under the 2019 Equity Incentive Plan, the Company may at its discretion grant to plan participants, such as directors, certain employees and service providers, awards in the form of restricted shares and RSUs, share options, share appreciation rights, performance awards and other share-based awards. The Company has reserved 17,741,355 common shares for future issuance under the 2019 Equity Incentive Plan (including share-based equity awards granted to date less awards forfeited). As of March 31, 2025, the Company has 1,382,040 common shares available for the future issuance of share-based equity awards. As of March 31, 2025 and December 31, 2024, the cumulative amount recorded as a net increase to additional paid-in capital within equity on the unaudited condensed consolidated balance sheets in respect of the 2019 Equity Incentive Plan was $162,554 and $160,945, respectively. The amounts of expense (reversal) recognized for all awards for services received during the three months ended March 31, 2025 and 2024 were $1,609 and $(981). Conditional Share Capital Plan In December 2023, the Company adopted the Conditional Share Capital Plan. Under the Conditional Share Capital Plan, the Company may at its discretion grant to plan participants, such as directors, certain employees and service providers, awards in the form of restricted shares and RSUs, share options, share appreciation rights, performance awards and other share-based awards. The Company has reserved 8,000,000 common shares for future issuance under this plan. On February 13, 2025 the Company issued its 2025 annual equity award under the Conditional Share Capital Plan, which was approved by the Compensation Committee of the Board of Directors and by the Board of Directors for the senior management team, consisted of 5,015,765 RSUs. No share options were issued in connection with this award. As of March 31, 2025, the Company has 1,429,378 common shares available for the future issuance of share-based equity awards. As of March 31, 2025 and December 31, 2024, the cumulative amount recorded as a net increase to additional paid-in capital within equity on the unaudited condensed consolidated balance sheet in respect of the Conditional Share Capital Plan was $3,512 and $2,964. The amounts of expense for all awards recognized for services received during the three months ended March 31, 2025 and 2024 was $548 and $1,063. Inducement Plan In December 2023, the Company adopted the Inducement Plan. Under the Inducement Plan, the Company may at its discretion grant to any employee who is eligible to receive an employment inducement grant in accordance with NYSE Listed Company Manual 303A.08. The maximum number of common shares in respect of which awards may be granted under the Inducement Plan is 1,000,000 common shares (including share-based equity awards granted to date, less awards forfeited), subject to adjustment in the event of certain corporate transactions or events if necessary to prevent dilution or enlargement of the benefits made available under the plan. Equity incentive awards under the Inducement Plan may be granted in the form of options, share appreciation rights, restricted shares, restricted share units, performance awards or other share-based awards but not “incentive stock options” for purposes of U.S. tax laws. As of March 31, 2025, the Company has 323,600 common shares available for the future issuance of share-based equity awards under this plan. As of March 31, 2025 and December 31, 2024, the cumulative amount recorded as a net increase to additional paid-in capital within equity on the unaudited condensed consolidated balance sheet in respect of the Inducement Plan was $817 and $554. The amounts of expense for all awards recognized for services received during the three months ended March 31, 2025 and 2024 was $263 and $0. Share Options Pursuant to the 2019 Equity Incentive Plan, the Conditional Share Capital Plan and Inducement Plan (the “Share-based Compensation Plans”), the Company may grant share options to its directors, certain employees and service providers working for the benefit of the Company at the time. The exercise price per share option is set by the Company at the fair market value of the underlying common shares on the date of grant, as determined by the Company, which is generally the closing share price of the Company’s common shares traded on the NYSE. The awards generally vest 25% on the first anniversary of the date of grant, and thereafter evenly on a monthly basis over the subsequent three years. The contractual term of each share option award granted is ten years. Under the grant, the options may be settled only in common shares of the Company. Therefore, the grants of share options under the 2019 Equity Incentive Plan and Inducement Plan have been accounted for as equity-settled under US GAAP. As such, the Company records a charge for the vested portion of award grants and for partially earned but non-vested portions of award grants. This results in a front-loaded charge to the Company’s unaudited condensed consolidated statements of operations and a corresponding increase to additional paid-in capital within equity on the unaudited condensed consolidated balance sheets. The expense (reversal) recognized for services received during the three months ended March 31, 2025 and 2024 was $1,129 and $(1,434), respectively. Movements in the number of awards outstanding under the Plans described above and their related weighted average strike prices are as follows:
As of March 31, 2025, 6,332,858 awards are vested and exercisable out of the total outstanding awards of 10,643,768 common shares. As of March 31, 2025, the weighted average strike price and weighted average remaining life for vested and exercisable awards is $11.96 and 6.64 years, respectively. Awards outstanding as of March 31, 2025 have expiration dates through 2035. The weighted average grant date fair value of the awards granted during the three months ended March 31, 2025 was $1.43. The aggregate intrinsic value of vested and exercisable options was zero. As of March 31, 2025, the unrecognized compensation cost related to 4,310,913 unvested share options expected to vest was $6.1 million. This unrecognized cost will be recognized over an estimated weighted-average amortization period of 1.49 years. The fair values of the options granted under the 2019 Equity Incentive Plan and the Inducement Plan were determined on the date of the grant using the Black-Scholes option-pricing model. The fair values of the options granted during the three months ended March 31, 2025 and 2024 were determined on the date of grant using the following assumptions:
Expected volatility is historical volatility of our common stock. The award life for options granted was based on the time interval between the date of grant and the date during the ten-year life after which, when making the grant, the Company expected on average that participants would exercise their options. RSUs Pursuant to the Share-based Compensation Plans, the Company may grant RSUs to its directors, certain employees and service providers working for the benefit of the Company at the time. The awards generally vest annually over a period of to three years commencing on the first anniversary of the date of grant. The RSUs may be settled only in common shares of the Company. Therefore, the grant of RSUs under both the 2019 Equity Incentive Plan and Conditional Share Capital Plan have been accounted for as equity-settled under US GAAP. As such, the Company records a charge for the vested portion of award grants and for partially earned but non-vested portions of award grants. This results in a front-loaded charge to the Company’s unaudited condensed consolidated statements of operations and a corresponding increase to additional paid-in capital within equity on the unaudited condensed consolidated balance sheets. The expense recognized for services received during the three months ended March 31, 2025 and 2024 is $1,291 and $1,516, respectively. The following table summarizes the RSU awards outstanding as of March 31, 2025:
(1) Includes 6,570,622 RSUs outstanding in connection with the Conditional Share Capital Pan. The total fair value of RSU awards vested (as measured on the date of vesting) during the three months ended March 31, 2025 was $260. Employee Stock Purchase Plan In June 2022, the Company adopted the 2022 Employee Stock Purchase Plan (“ESPP”), which allows eligible employees to purchase designated shares of the Company's common shares at a discount, over a series of offering periods through accumulated payroll deductions. The Company offers the ESPP to employees twice a year with each having a six-month offering period. The first offering period is generally from January 1st through June 30th and the second offering period is from July 1st through December 31st. The grant date is the first day of each offering period. The ESPP is not available for enrollment during the first offering period from January 1, 2025 through June 30, 2025. The expense recognized related to the ESPP during the three months ended March 31, 2025 and 2024 is $0 and $76, respectively.
|
Loss per share |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2025 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Earnings Per Share [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Loss per share | Loss per share The basic loss per share is calculated by dividing the net loss attributable to shareholders by the weighted average number of shares in issue during the period, excluding common shares owned by the Company and held as treasury shares, as follows:
For the three months ended March 31, 2025 and 2024, basic and diluted loss per share are calculated on the weighted average number of shares issued and outstanding and also include the Pre-funded warrants issued in connection with the 2024 Equity Offering. The calculation excludes shares to be issued under the Share-based Compensation Plans, the Company’s Deerfield warrants and shares to be issued under the 2022 ESPP as the effect of including those shares would be anti-dilutive. See Note 8, “Senior secured term loan facility,” Note 9, “Deerfield warrants”, and Note 15, “Share-based compensation,” for further information. Potentially dilutive securities that were not included in the diluted per share calculations because the effect of including them would be anti-dilutive were as follows:
|
Segment reporting |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2025 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Segment Reporting [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Segment reporting | Segment reporting The Company is managed and operated as one reportable segment, which includes all global activities related to the development and commercialization of targeted ADC cancer therapies. The determination of a single reportable segment is consistent with the consolidated financial information regularly provided to the Company’s CODM, which is its chief executive officer. The CODM uses loss from operations and consolidated net loss for purposes of assessing performance, making operating decisions, allocating resources and planning and forecasting for future periods. The CODM allocates resources and plans for the long-term growth of the Company based on the Company's available cash resources, forecasted cash flow, and expenditures on a consolidated basis, as well as an assessment of the probability of success of its research and development activities. Resource allocation and long-term growth decisions are informed by budgeted and forecasted expense information, along with actual expenses incurred to date. The measure of segment assets is reported on the consolidated balance sheets as total assets. The following table is the summary of the segment profit or loss information, including the significant expense categories for the three months ended March 31, 2025 and 2024, respectively:
(1)Excludes share-based compensation (2)Includes Other expense, net, Income tax expense and Equity in net losses of joint venture
|
Pay vs Performance Disclosure - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2025 |
Mar. 31, 2024 |
|
Pay vs Performance Disclosure | ||
Loss for the period | $ (38,602) | $ (46,606) |
Insider Trading Arrangements |
3 Months Ended |
---|---|
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 |
---|---|
Mar. 31, 2025 | |
Accounting Policies [Abstract] | |
Basis of preparation and principles of consolidation | Basis of preparation and principles of consolidation These accompanying unaudited condensed consolidated financial statements, which include the accounts of the Company and its wholly-owned subsidiaries, have been prepared following the requirements of the U.S. Securities and Exchange Commission for interim reporting. As permitted under those rules, certain footnotes and other financial information that are normally required by U.S. generally accepted accounting principles, or U.S. GAAP, can be condensed or omitted. All intercompany transactions and balances have been eliminated in consolidation. The information included in this Quarterly Report on Form 10‑Q should be read in conjunction with our annual audited consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10‑K for the year ended December 31, 2024. In the opinion of management, these condensed consolidated financial statements have been prepared on the same basis as the annual audited consolidated financial statements and include all adjustments, consisting only of normal recurring adjustments, considered necessary for the fair statement of our financial position and operating results. The results for the three months ended March 31, 2025 are not necessarily indicative of the results to be expected for the year ending December 31, 2025, for any other interim period or for any future period. The Company’s significant accounting policies have not changed substantially from those previously described in the Company’s Annual Report on Form 10‑K for the year ended December 31, 2024.
|
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures in the consolidated financial statements and accompanying notes. Management bases its estimates on historical experience and on assumptions believed to be reasonable under the circumstances. Actual results could differ materially from those estimates.
|
Recent Accounting Pronouncements | Recent Accounting Pronouncements Issued but not yet adopted In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The ASU requires the annual financial statements to include consistent categories and greater disaggregation of information in the rate reconciliation, and income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for the Company’s annual reporting periods beginning in January 2025. Adoption is either with a prospective method or a fully retrospective method of transition. Early adoption is permitted. The Company is currently evaluating the effect that adoption of ASU 2023-09 will have on its consolidated financial statements. The Company does not anticipate adoption of this standard will have a material impact on our financial results but may result in enhanced or expanded 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 Disclosure. The ASU requires disaggregation, in the notes to the financial statements, of certain cost and expense captions presented on the face of the Company’s interim and annual financial statements. ASU 2023-09 is effective for fiscal years beginning in January 2027 and interim periods beginning January 2028, with early adoption permitted. Adoption may be applied prospectively or retrospectively. The Company is currently evaluating the effect that adoption of ASU 2024-03 will have on its consolidated financial statements.
|
Inventory (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2025 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Inventory | As of March 31, 2025 and December 31, 2024 inventory consisted of the following:
|
Property and equipment (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2025 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property, Plant and Equipment [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Property, Plant and Equipment | Property and equipment as of March 31, 2025 and December 31, 2024 consisted of the following:
|
Accrued expenses and other current liabilities (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2025 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consist of the following:
|
Senior secured term loan facility (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2025 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Long-Term Debt Instruments | The following table provides a summary of the interest expense for the Company’s senior secured term loan for the three months ended March 31, 2025 and 2024:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Maturities of Long-Term Debt | Contractual payments due under our senior secured term loans, including exit fees are as follows (in thousands):
|
Deerfield warrants (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2025 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other Liabilities Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Fair Value Measurement Inputs and Valuation Techniques | Key inputs for the valuation of the warrant obligation as of March 31, 2025 and December 31, 2024 were as follows:
|
Deferred royalty obligation (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2025 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other Liabilities Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Royalty Purchase Obligation | The table below provides a rollforward of the Company’s debt obligation relating to the royalty purchase agreement.
|
Pension and post-retirement benefit obligations (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2025 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Retirement Benefits [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Net Benefit Costs | The net periodic benefit cost for the three months ended March 31, 2025 and 2024 is as follows:
|
Revenue (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2025 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue from Contract with Customer [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Disaggregation of Revenue | The table below provides a disaggregation of revenues by type and customer location for the three months ended March 31, 2025 and 2024:
(1) Europe, the Middle East and Africa The table below provides a rollforward of the Company’s accruals related to the gross-to-net (“GTN”) sales adjustments for the three months ended March 31, 2025 and March 31, 2024:
The table below provides the classification of the accruals related to the GTN sales adjustment included in the Company’s unaudited condensed consolidated balance sheets as of March 31, 2025 and December 31, 2024.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Product Revenue by Customer | Customers from which we derive more than 10% of our total product revenues for the three months ended March 31, 2025 and 2024 are as follows:
(1) AmerisourceBergen also operates under the name Cencora
|
Other income (expense) (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2025 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other Income and Expenses [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Interest Expense | The components of Interest expense for the three months ended March 31, 2025 and 2024 are as follows:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Other, Net | The components of Other, net for the three months ended March 31, 2025 and 2024 are as follows:
|
Share-based compensation (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2025 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-Based Payment Arrangement [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Share-Based Payment Arrangement, Option, Activity | Movements in the number of awards outstanding under the Plans described above and their related weighted average strike prices are as follows:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions | The fair values of the options granted during the three months ended March 31, 2025 and 2024 were determined on the date of grant using the following assumptions:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Share-Based Payment Arrangement, Restricted Stock Unit, Activity | The following table summarizes the RSU awards outstanding as of March 31, 2025:
(1) Includes 6,570,622 RSUs outstanding in connection with the Conditional Share Capital Pan.
|
Loss per share (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2025 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Earnings Per Share [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Loss per Share | The basic loss per share is calculated by dividing the net loss attributable to shareholders by the weighted average number of shares in issue during the period, excluding common shares owned by the Company and held as treasury shares, as follows:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Potentially Dilutive Securities Excluded from Earnings Per Share Calculation | Potentially dilutive securities that were not included in the diluted per share calculations because the effect of including them would be anti-dilutive were as follows:
|
Segment reporting (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2025 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Segment Reporting [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Segment Reporting Information, by Segment | The following table is the summary of the segment profit or loss information, including the significant expense categories for the three months ended March 31, 2025 and 2024, respectively:
(1)Excludes share-based compensation (2)Includes Other expense, net, Income tax expense and Equity in net losses of joint venture
|
Description of Business and Organization (Details) |
3 Months Ended |
---|---|
Mar. 31, 2025
subsidiary
| |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Number of subsidiaries | 2 |
Fair value measurements (Details) - USD ($) $ in Thousands |
Mar. 31, 2025 |
Dec. 31, 2024 |
---|---|---|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Deferred royalty obligation, fair value | $ 312,000 | $ 312,000 |
Deerfield Warrants | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Deerfield obligation, fair value | $ 0 | |
Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Deerfield obligation, fair value | $ 0 |
Inventory - Schedule of Inventory (Details) - USD ($) $ in Thousands |
Mar. 31, 2025 |
Dec. 31, 2024 |
---|---|---|
Inventory Disclosure [Abstract] | ||
Work in progress | $ 17,238 | $ 18,338 |
Finished goods | 209 | 49 |
Inventory | $ 17,447 | $ 18,387 |
Inventory - Narrative (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2025 |
Mar. 31, 2024 |
|
Inventory Disclosure [Abstract] | ||
Write-downs of inventory | $ 1,246 | $ 748 |
Property and equipment - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands |
Mar. 31, 2025 |
Dec. 31, 2024 |
---|---|---|
Property, Plant and Equipment [Line Items] | ||
Property and equipment | $ 10,953 | $ 10,395 |
Less: accumulated depreciation | (5,797) | (5,320) |
Property and equipment, net | 5,156 | 5,075 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | 3,989 | 3,873 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | 4,817 | 4,415 |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | 994 | 970 |
Hardware and computer software | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | $ 1,153 | $ 1,137 |
Property and equipment - Narrative (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2025 |
Mar. 31, 2024 |
|
Property, Plant and Equipment [Abstract] | ||
Depreciation | $ 342 | $ 331 |
Income taxes (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2025 |
Mar. 31, 2024 |
|
Income Tax Disclosure [Abstract] | ||
Income tax expense | $ 165 | $ 163 |
Loss before income taxes | $ 38,437 | $ 45,756 |
Accrued expenses and other current liabilities (Details) - USD ($) $ in Thousands |
Mar. 31, 2025 |
Dec. 31, 2024 |
---|---|---|
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Accrued R&D costs | $ 18,722 | $ 20,523 |
Accrued payroll and benefits | 4,509 | 13,600 |
Gross-to-net sales adjustments, short-term | 8,192 | 15,697 |
Operating lease liabilities, short-term | 1,368 | 1,371 |
Other | 9,411 | 11,249 |
Accrued expenses and other current liabilities | $ 42,202 | $ 62,440 |
Senior secured term loan facility - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | |||
---|---|---|---|---|
Aug. 15, 2022 |
Mar. 31, 2025 |
Mar. 31, 2024 |
Dec. 31, 2024 |
|
Debt Instrument [Line Items] | ||||
Issuance of shares (in shares) | 733,568 | |||
Senior secured term loans | $ 113,823 | $ 113,632 | ||
Loan Agreement Warrants | ||||
Debt Instrument [Line Items] | ||||
Securities called by warrant (in shares) | 527,295 | |||
Warrant exercise price (in dollars per share) | $ 8.30 | |||
Loan Agreement | ||||
Debt Instrument [Line Items] | ||||
Interest expense on debt | 3,785 | $ 4,403 | ||
Line of Credit | Loan Agreement | Secured Debt | ||||
Debt Instrument [Line Items] | ||||
Face amount | $ 175,000 | |||
Long-term debt | $ 120,000 | |||
Interest expense on debt | $ 3,785 | $ 4,403 | ||
Debt effective interest rate | 16.15% |
Senior secured term loan facility - Schedule of Interest Expense (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2025 |
Mar. 31, 2024 |
|
Debt Instrument [Line Items] | ||
Amortization of debt discount, senior secured term loan | $ 191 | $ 503 |
Loan Agreement | ||
Debt Instrument [Line Items] | ||
Total | 3,785 | 4,403 |
Loan Agreement | Line of Credit | Secured Debt | ||
Debt Instrument [Line Items] | ||
Contractual interest expense | 3,594 | 3,900 |
Amortization of debt discount, senior secured term loan | 191 | 503 |
Total | $ 3,785 | $ 4,403 |
Senior secured term loan facility - Schedule of Maturities (Details) - Loan Agreement $ in Thousands |
Mar. 31, 2025
USD ($)
|
---|---|
Debt Instrument [Line Items] | |
2025 (remainder) | $ 0 |
2026 (commencing third quarter) | 3,090 |
2027 | 9,330 |
2028 | 12,480 |
2029 | 99,840 |
Total | $ 124,740 |
Deerfield warrants - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | |||
---|---|---|---|---|
Aug. 15, 2022 |
Mar. 31, 2025 |
Mar. 31, 2024 |
Dec. 31, 2024 |
|
Class of Warrant or Right [Line Items] | ||||
Deerfield warrant obligation, change in fair value expense | $ 0 | $ (3,068) | ||
Fair Value, Inputs, Level 2 [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Deerfield obligation, fair value | 0 | |||
Deerfield Warrants | ||||
Class of Warrant or Right [Line Items] | ||||
Debt conversion, warrants issued (in shares) | 4,412,840 | |||
Deerfield warrant obligation, change in fair value expense | $ 0 | $ (3,068) | ||
Deerfield obligation, fair value | $ 0 | |||
Deerfield Warrants | Warrants, Tranche One | ||||
Class of Warrant or Right [Line Items] | ||||
Debt conversion, warrants issued (in shares) | 2,631,578 | |||
Warrant exercise price (in dollars per share) | $ 24.70 | |||
Deerfield Warrants | Warrants, Tranche Two | ||||
Class of Warrant or Right [Line Items] | ||||
Debt conversion, warrants issued (in shares) | 1,781,262 | |||
Warrant exercise price (in dollars per share) | $ 28.07 |
Deferred royalty obligation - Narrative (Details) - USD ($) $ in Millions |
12 Months Ended | |
---|---|---|
Aug. 25, 2021 |
Dec. 31, 2023 |
|
Other Liabilities Disclosure [Abstract] | ||
Royalty purchase agreement | $ 325.0 | |
Proceeds from royalties | $ 225.0 | $ 75.0 |
Deferred royalty obligation - Schedule of Royalty Obligation (Details) - USD ($) $ in Thousands |
3 Months Ended | 12 Months Ended |
---|---|---|
Mar. 31, 2025 |
Dec. 31, 2024 |
|
Deferred Royalty Obligation [Roll Forward] | ||
Beginning balance | $ 326,659 | $ 309,613 |
Less: royalty payments | 1,376 | 5,384 |
Plus: interest expense | 8,445 | 33,608 |
Less: cumulative catch-up adjustment, Other, net | 12 | 11,178 |
Ending balance | $ 333,716 | $ 326,659 |
Pension and post-retirement benefit obligations - Narrative (Details) |
3 Months Ended |
---|---|
Mar. 31, 2025 | |
Retirement Benefits [Abstract] | |
Capital and interest guarantee | 100.00% |
Pension and post-retirement benefit obligations - Schedule of Net Periodic Benefit Cost (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2025 |
Mar. 31, 2024 |
|
Retirement Benefits [Abstract] | ||
Service cost | $ 188 | $ 164 |
Interest cost | 25 | 38 |
Expected return on plan assets | (65) | (59) |
Amortization of prior service cost | (42) | (41) |
Amortization of actuarial losses | 5 | 0 |
Net periodic benefit cost | $ 111 | $ 102 |
Revenue - Schedule of Disaggregation of Revenues (Details) - USD ($) $ in Thousands |
1 Months Ended | 3 Months Ended | |
---|---|---|---|
Mar. 31, 2025 |
Mar. 31, 2025 |
Mar. 31, 2024 |
|
Disaggregation of Revenue [Line Items] | |||
Total revenues, net | $ 23,033 | $ 18,053 | |
U.S. | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues, net | 17,404 | 17,848 | |
EMEA | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues, net | 5,629 | 205 | |
Product revenues, net | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues, net | 17,404 | 17,848 | |
License revenues | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues, net | $ 5,000 | 5,000 | 0 |
Royalties | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues, net | $ 629 | $ 205 |
Revenue - Schedule of Concentration Risk by Customer (Details) - Revenue Benchmark - Customer Concentration Risk |
3 Months Ended | |
---|---|---|
Mar. 31, 2025 |
Mar. 31, 2024 |
|
McKesson | ||
Disaggregation of Revenue [Line Items] | ||
Concentration risk percentage | 34.00% | 43.00% |
AmerisourceBergen Corporation | ||
Disaggregation of Revenue [Line Items] | ||
Concentration risk percentage | 42.00% | 38.00% |
Cardinal Health | ||
Disaggregation of Revenue [Line Items] | ||
Concentration risk percentage | 24.00% | 19.00% |
Revenue - Narrative (Details) - USD ($) $ in Thousands |
1 Months Ended | 3 Months Ended | |
---|---|---|---|
Mar. 31, 2025 |
Mar. 31, 2025 |
Mar. 31, 2024 |
|
Disaggregation of Revenue [Line Items] | |||
Total revenues, net | $ 23,033 | $ 18,053 | |
License revenues | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues, net | $ 5,000 | $ 5,000 | $ 0 |
Other income (expense) - Narrative (Details) - USD ($) $ in Millions |
3 Months Ended | |
---|---|---|
Mar. 31, 2025 |
Mar. 31, 2024 |
|
Other Income and Expenses [Abstract] | ||
Interest income | $ 2.1 | $ 2.9 |
Other income (expense) - Schedule of Interest Expense (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2025 |
Mar. 31, 2024 |
|
Debt Instrument [Line Items] | ||
Deferred royalty obligation interest expense | $ 8,445 | $ 8,093 |
Interest expense | 12,230 | 12,496 |
Loan Agreement | ||
Debt Instrument [Line Items] | ||
Effective interest expense on senior secured term loan facility | $ 3,785 | $ 4,403 |
Other income (expense) - Schedule of Other, Net (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2025 |
Mar. 31, 2024 |
|
Debt Instrument [Line Items] | ||
Deerfield warrant obligation, change in fair value expense | $ 0 | $ 3,068 |
Cumulative catch-up adjustment, deferred royalty obligation | 12 | 263 |
Exchange differences loss | (90) | (37) |
R&D tax credit gain | 281 | 247 |
Other, net | 203 | (2,595) |
Deerfield Warrants | ||
Debt Instrument [Line Items] | ||
Deerfield warrant obligation, change in fair value expense | $ 0 | $ 3,068 |
Share-based compensation - Schedule of Option Activity (Details) - $ / shares |
3 Months Ended | 12 Months Ended |
---|---|---|
Mar. 31, 2025 |
Dec. 31, 2024 |
|
Weighted average strike price per share (in $ per share) | ||
Beginning balance (in dollars per share) | $ 8.69 | |
Granted (in dollars per share) | 1.76 | |
Forfeited (in dollars per share) | 2.97 | |
Expired (in dollars per share) | 21.11 | |
Ending balance (in dollars per share) | $ 8.66 | $ 8.69 |
Number of awards | ||
Beginning balance (in shares) | 10,697,288 | |
Granted (in shares) | 46,800 | |
Forfeited (in shares) | (63,587) | |
Expired (in shares) | (36,733) | |
Ending balance (in shares) | 10,643,768 | 10,697,288 |
Additional Disclosures | ||
Weighted average remaining life in years | 7 years 3 months 21 days | 7 years 6 months 21 days |
Share-based compensation - Schedule of RSU Activity (Details) - Restricted Stock Units |
3 Months Ended |
---|---|
Mar. 31, 2025
$ / shares
shares
| |
Number of awards | |
Beginning balance (in shares) | 3,106,310 |
Granted (in shares) | 5,015,765 |
Vested (in shares) | (153,308) |
Forfeited (in shares) | (53,769) |
Ending balance (in shares) | 7,914,998 |
Weighted average grant date fair value | |
Beginning balance (in dollars per share) | $ / shares | $ 1.81 |
Granted (in dollars per share) | $ / shares | 1.61 |
Vested (in dollars per share) | $ / shares | 6.60 |
Forfeited (in dollars per share) | $ / shares | 1.35 |
Ending balance (in dollars per share) | $ / shares | $ 1.59 |
Conditional Share Capital Plan - RSUs | |
Number of awards | |
Ending balance (in shares) | 6,570,622 |
Loss per share - Schedule of Loss per Share (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2025 |
Mar. 31, 2024 |
|
Earnings Per Share [Abstract] | ||
Net loss | $ (38,602) | $ (46,606) |
Weighted average number of shares outstanding, diluted (in shares) | 107,202,374 | 82,552,322 |
Weighted average number of shares outstanding, basic (in shares) | 107,202,374 | 82,552,322 |
Net loss per share, diluted (in dollars per share) | $ (0.36) | $ (0.56) |
Net loss per share, basic (in dollars per share) | $ (0.36) | $ (0.56) |
Segment reporting - Additional Information (Details) |
3 Months Ended |
---|---|
Mar. 31, 2025
segment
| |
Segment Reporting [Abstract] | |
Number of reportable segments | 1 |
Segment reporting - Schedule of Segment Reporting Information, by Segment (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2025 |
Mar. 31, 2024 |
|
Segment Reporting Information [Line Items] | ||
Total revenues, net | $ 23,033 | $ 18,053 |
Total operating expense | (51,497) | (51,666) |
Loss from operations | (28,464) | (33,613) |
Net loss | (38,602) | (46,606) |
Reportable Segment | ||
Segment Reporting Information [Line Items] | ||
Total revenues, net | 23,033 | 18,053 |
Cost of product sales | (2,061) | (2,510) |
Research and development | (27,936) | (26,285) |
Selling and marketing | (10,317) | (12,030) |
General and administrative | (8,762) | (10,683) |
Share-based compensation | (2,421) | (158) |
Total operating expense | (51,497) | (51,666) |
Loss from operations | (28,464) | (33,613) |
Other segment items | (10,138) | (12,993) |
Net loss | $ (38,602) | $ (46,606) |
TA[%'_8UT0\JBMGXW-8*Y_S*=5"5;N-)K?F6W K)ZZXB_,0
M-H .8_)T0]:D;748U8P&?LK^L6;%+X3?5JA,/8SQ%&2@5_3 10<)?N#*9W'HL2B(
MQ@?HQ:VH,=&+#XKZCD2]YH_@689=*,7+A:#?_[JXU4:!F_Q[E_"6]F@W;0R=
M5WK%4_'V"&)#"W4OCLZ_^DN8!*\/<#YJ.1\=HOXB(WT>)?:/I6#OX08O']F2
M:\:S:F5@T3U7LJHUT_LVRC(%Y4%DL57.2^VS3V!^Q )-O./"CA:EM@M^&M>X@$?0/^JM-#-_H!!: 5=4<"0A3[S59+E>V'@7\)-"
MJT[&R%:R%^+93C8D\0(K! PR;0G8/ YP#XQ9D-'XW3.]84N;>#H^TK^ZVDTM
M>ZS@7K!?E.@R\3YXB$".&Z9WHOT&?3TSR\L$4^X7M5UL]-%#6:.TJ/ID8U!1
MWCWQ2W\.)PF&##B+1 &JEKD5-MWV8]L&$"[&:Q)EMH/WWLQV(*$T?D_8E\;7O.3[GQKD>
M;"E[X#F 0(]E4?&AD0M1GYLFSW(H,>_1&BJYLJ2LQ$*&;&7RF@%>:%!9F(YE
M!6:)267$ STW8_& KD5!*I@QQ-=EB=G3!11T.S1L8S]Q1U:Y4!-F/*CQ"E(0
MW^L9DY'9LBQ("14GM$(,ED-C9)\G@A?QU2[E4U,\M.OZ%DG*=7R>B\VD+4/
M1H\"Q*JG,R#8)HAOE
M,=A/SE:E>,GK!D/<:1% J&A1M##/T&;:WF/=R:;?V+3OMS3=Z[>;:WIXK+HW
M9,C-+E3:[L;@'/<1?>"ZS3+IKBL/:@YQ:OX86VZ'M<+P:1J'TL%3MXKAUMT1
M LCB#9G]5R;4U\ANM[N$3^N[Y_WQ^@:/"UJFT)V:5C =#7Y\W1.NOA77BV#+
M>!-=VH![;7S,\8\$.3Z ]RN+[T:SX #=OR:G_P!02P,$% @ \("N6A&A
M+?=I!P KQ, !@ !X;"]W;W)K
/%F-EG$5".:Q6DKEW)'GD\UXVC]QI:N12"U
MP[#,B!G%GI4C^F9 Y]]!S^&ML]0$^,-66'V+SUC))"??R[G)3Q*^53Z%^?D9
MY+/\X@3??$IO'OGFI]-[KW;P6H?2N-!YA$_712#/'\0_QU(>&!?'&:5)KL)6
ME;A*N L"^@=,UL]_.W\Q>WE"[V+2NSC%_L/K^/]H>-H [KB' P+W,%##ML8C
M0CM<'
^) KB
MH=+&7XS*$.K3R<1G)572CVU-!B>%=94,6+KUQ->.9!Z5*CV93Z?'DTHJ,UJ>
MQ[T;MSRW3=#*T(T3OJDJZ797I.WV8C0;=1NW:ET&WI@LSVNYICL*?]8W#JM)
MCY*KBHQ7U@A'Q<7H
(&P*91A6@&_F1U4KFWOAB&Y;?P.W3T1%2
MKT4FB@6(W^:__[A:'BE]HKRML#;[M'JI
MRY?MMY)\(97TC1/)B=*(:[J#>4:IMF+;9A#=K"1G6R)WP(_2"G*ALJF%'$,XL_&Y5S*
M ".;G+22/]KBN6>VGEZ)+R7 U82W(:M;V&QI/VN8LBN^EOP>75C8LJ4FF0A;
MM,.ZTX9?>\2G&_;MQ<4U83&VDOUHL_"*T)HN,1>W08(&!AJ0Y&VVGG?5:".-
M\A"VJN01H$_R4$IEY6E_OQX20#U):@'KW(XJ.)LK,.=I7I$+.G8<3@V]]DD<
MUP;^%,*IOH+8Y98/9)QC^8+ CN@&8?('#F4:9'EJ:/*[YH/0"Z-F2 )]6SPZ
M&0YU/N! UM9M5JQ-2=N4+[4!G5I];7R78M)^K:BBIN"' !0B9R4
ML*;W7K@ Y(4^EF'9=.>@"8R")1>6HWE>K?4K]M.AY1T@A@J8?;&Y/F'?#]G>
MHJ0$OH1$*7(Y%R@N(0&[6"R46"!870&F2.BM4_8CX;8]Q"RK6H-@^H3]T%$%
M)__:JF:@)O"3&0L#+YE-O&@Z91-_G 9\N#H-?O6H5'H3Q(V2KPIE&+?--4X
MB_S9A!TGT!9.)R?L\F$%20_NAGX8LN,X\29QO(N-@1,@#PGQ,(J]28(\Q&&'
MA]V%8N+%<>1-Q]-VJ*-:-$##NJQ(12(X18-_IL(0Z7I)XSCS+@L][#Q4JQ[T
M&&)D:\7 M!A&>_ANQF(8&Z$_2VA!XB
!"9T;)(O K@:6)!QR*,RV.EZI3W*I[UEIS*XL'1_JX??=BGT 9;(N0MB9+3L?&<%69&F<#M>]' AV5^B1;X4,&5T]8J2QBK4/E)
MB=XI0)JAJ#N]>_@]@&ZY5"&;X%(_6$A&?M *GTI<)$DP+.YP-Q62Z%+UHC8>
MA1*6)$7!L2VF/OURW8