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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
| | | | | |
☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
| For the quarterly period ended June 30, 2024 |
OR |
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
| For the transition period from to |
Commission File Number: 001-39071
ADC Therapeutics SA
(Exact name of registrant as specified in its charter)
| | | | | |
Switzerland | Not Applicable |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
| |
Biopôle Route de la Corniche 3B 1066 Epalinges Switzerland (Address of principal executive offices) (Zip code) |
+41 21 653 02 00 (Registrant’s telephone number) |
N/A
(Former name or former address, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
| | | | | | | | | | | | | | |
Title of each class | | Trading symbol(s) | | Name of each exchange on which registered |
Common Shares, par value CHF 0.08 per share | | ADCT | | The New York Stock Exchange |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| | | | | | | | | | | | | | | | | | | | |
Large accelerated filer | | ☐ | | Accelerated filer | | ☒ |
Non-accelerated filer | | ☐ | | Smaller reporting company | | ☒ |
| | | | Emerging growth company | | ☐ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The number of common shares outstanding was 96,647,450 as of August 1, 2024.
Table of Contents
Unless otherwise indicated or the context otherwise requires, all references in this Annual Report to “ADC Therapeutics,” “ADCT,” the “Company,” “we,” “our,” “ours,” “us” or similar terms refer to ADC Therapeutics SA and its consolidated subsidiaries.
FORWARD-LOOKING STATEMENTS
This Quarterly Report contains statements that constitute forward-looking statements. All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding our future catalysts, results of operations and financial position, business and commercial strategy, market opportunities, products and product candidates, research pipeline, ongoing and planned preclinical studies and clinical trials, regulatory submissions and approvals, research and development costs, projected revenues and expenses and the timing of revenues and expenses, timing and likelihood of success, as well as plans and objectives of management for future operations are forward-looking statements. Many of the forward-looking statements contained in this Quarterly Report can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate,” “will” and “potential,” among others.
Forward-looking statements are based on our management’s beliefs and assumptions and on information available to our management at the time such statements are made. Such statements are subject to known and unknown risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to:
•the substantial net losses that we have incurred since our inception, our expectation to continue to incur losses for the foreseeable future and our need to raise additional capital to fund our operations and execute our business plan;
•our indebtedness under the loan agreement and guaranty (the “Loan Agreement”) with certain affiliates and/or funds managed by each of Oaktree Capital Management, L.P. and Owl Rock Capital Advisors LLC, as lenders, and Blue Owl Opportunistic Master Fund I, L.P., as administrative agent, and the associated restrictive covenants thereunder;
•the purchase and sale agreement (the “HCR Agreement”) with certain entities managed by HealthCare Royalty Management, LLC (“HCR”) and its negative effect on the amount of cash that we are able to generate from sales of, and licensing agreements involving, ZYNLONTA and on our attractiveness as an acquisition target;
•our ability to complete clinical trials on expected timelines, if at all;
•the timing, outcome and results of ongoing or planned clinical trials, whether the Company sponsored trials or through investigator initiated trials, and the sufficiency of such results;
•undesirable side effects or adverse events of our products and product candidates;
•our and our partners’ ability to obtain and maintain regulatory approval for our product and product candidates;
•our and our partners’ ability to successfully commercialize our products;
•the availability and scope of coverage and reimbursement for our products;
•the complexity and difficulty of manufacturing our products and product candidates;
•the substantial competition in our industry, including new technologies and therapies;
•the timing and results of any early research projects and future clinical outcomes;
•our reliance on third parties for preclinical studies and clinical trials and for the manufacture, production, storage and distribution of our products and product candidates and certain commercialization activities for our products;
•our ability to obtain, maintain and protect our intellectual property rights and our ability to operate our business without infringing on the intellectual property rights of others;
•our estimates regarding future revenue, expenses and needs for additional financing;
•the size and growth potential of the markets for our products and product candidates potential product liability lawsuits and product recalls;
•our ability to identify and successfully enter into strategic collaborations for research or licensing opportunities in the future;
•and those identified in the “Item 1A. Risk Factors” section contained in this Quarterly Report and our Annual Report on Form 10-K, and in our other reports filed with the U.S. Securities and Exchange Commission (the “SEC”), from time to time thereafter.
Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise.
In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements.
PART I: FINANCIAL INFORMATION
Item 1. Financial Statements
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(in thousands, except share amounts)
| | | | | | | | | | | | | |
| | | June 30, 2024 | | December 31, 2023 |
ASSETS | | | | | |
Current assets | | | | | |
Cash and cash equivalents | | | $ | 300,119 | | | $ | 278,598 | |
Accounts receivable, net | | | 22,868 | | | 25,182 | |
Inventory | | | 15,191 | | | 16,177 | |
Prepaid expenses and other current assets | | | 17,181 | | | 16,334 | |
Total current assets | | | 355,359 | | | 336,291 | |
| | | | | |
Property and equipment, net | | | 5,483 | | | 5,622 | |
Operating lease right-of-use assets | | | 9,685 | | | 10,511 | |
Interest in joint venture | | | 260 | | | 1,647 | |
| | | | | |
Other long-term assets | | | 992 | | | 711 | |
| | | | | |
Total assets | | | $ | 371,779 | | | $ | 354,782 | |
| | | | | |
LIABILITIES AND SHAREHOLDERS’ EQUITY | | | | | |
Current liabilities | | | | | |
Accounts payable | | | $ | 10,708 | | | $ | 15,569 | |
Accrued expenses and other current liabilities | | | 46,924 | | | 52,101 | |
| | | | | |
Total current liabilities | | | 57,632 | | | 67,670 | |
| | | | | |
Deferred royalty obligation, long-term | | | 316,211 | | | 303,572 | |
Senior secured term loans | | | 113,673 | | | 112,730 | |
Operating lease liabilities, long-term | | | 9,309 | | | 10,180 | |
Other long-term liabilities | | | 6,624 | | | 8,879 | |
Total liabilities | | | 503,449 | | | 503,031 | |
Commitments and contingencies (See Note 13) | | | | | |
Shareholders’ equity (deficit) | | | | | |
Common shares, at CHF 0.08 par value | | | 8,233 | | | 7,312 | |
Issued shares: 99,453,858 at June 30, 2024 and 89,041,946 December 31, 2023; outstanding shares: 96,469,641 at June 30, 2024 and 82,293,137 at December 31, 2023 | | | | | |
Additional paid-in capital | | | 1,279,296 | | | 1,180,545 | |
Treasury shares | | | (239) | | | (541) | |
At June 30, 2024: 2,984,217 and December 31, 2023: 6,748,809 | | | | | |
Accumulated other comprehensive loss | | | (338) | | | (93) | |
Accumulated deficit | | | (1,418,622) | | | (1,335,472) | |
Total shareholders’ equity (deficit) | | | (131,670) | | | (148,249) | |
| | | | | |
Total liabilities and shareholders’ equity (deficit) | | | $ | 371,779 | | | $ | 354,782 | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(in thousands, except share and per share amounts)
| | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | For the Three Months Ended June 30, | | For the Six Months Ended June 30, | | |
| | | 2024 | | 2023 | | 2024 | | 2023 | | |
Revenue | | | | | | | | | | | |
Product revenues, net | | | $ | 17,030 | | | $ | 19,197 | | | $ | 34,878 | | | $ | 38,150 | | | |
License revenues and royalties | | | 380 | | | 86 | | | 585 | | | 125 | | | |
Total revenue, net | | | 17,410 | | | 19,283 | | | 35,463 | | | 38,275 | | | |
Operating expense | | | | | | | | | | | |
Cost of product sales | | | (1,217) | | | (1,132) | | | (3,727) | | | (1,105) | | | |
Research and development | | | (24,295) | | | (31,342) | | | (50,030) | | | (69,717) | | | |
Selling and marketing | | | (10,701) | | | (14,456) | | | (22,091) | | | (29,807) | | | |
General and administrative | | | (10,238) | | | (12,002) | | | (22,269) | | | (27,505) | | | |
Total operating expense | | | (46,451) | | | (58,932) | | | (98,117) | | | (128,134) | | | |
Loss from operations | | | (29,041) | | | (39,649) | | | (62,654) | | | (89,859) | | | |
Other income (expense) | | | | | | | | | | | |
Interest income | | | 3,253 | | | 2,372 | | | 6,201 | | | 4,547 | | | |
Interest expense | | | (12,679) | | | (10,309) | | | (25,175) | | | (20,600) | | | |
Other, net | | | 2,754 | | | (5,067) | | | 159 | | | (4,234) | | | |
| | | | | | | | | | | |
Total other expense, net | | | (6,672) | | | (13,004) | | | (18,815) | | | (20,287) | | | |
Loss before income taxes | | | (35,713) | | | (52,653) | | | (81,469) | | | (110,146) | | | |
Income tax (expense) benefit | | | (234) | | | 4,498 | | | (397) | | | 3,980 | | | |
Loss before equity in net losses of joint venture | | | (35,947) | | | (48,155) | | | (81,866) | | | (106,166) | | | |
Equity in net losses of joint venture | | | (597) | | | (767) | | | (1,284) | | | (2,130) | | | |
Net loss | | | $ | (36,544) | | | $ | (48,922) | | | $ | (83,150) | | | $ | (108,296) | | | |
Net loss per share | | | | | | | | | | | |
Net loss per share, basic and diluted | | | $ | (0.38) | | | $ | (0.60) | | | $ | (0.93) | | | $ | (1.33) | | | |
Weighted average shares outstanding, basic and diluted | | | 95,691,245 | | 81,471,127 | | 89,121,783 | | 81,140,287 | | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(Unaudited)
(in thousands)
| | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | For the Three Months Ended June 30, | | For the Six Months Ended June 30, | | |
| | | 2024 | | 2023 | | 2024 | | 2023 | | |
Net loss | | | $ | (36,544) | | | $ | (48,922) | | | $ | (83,150) | | | $ | (108,296) | | | |
| | | | | | | | | | | |
Other comprehensive (loss) income: | | | | | | | | | | | |
Remeasurement of defined benefit plan | | | (81) | | | (40) | | | (81) | | | (79) | | | |
Currency translation differences | | | 17 | | | 170 | | | (61) | | | 311 | | | |
Other comprehensive (loss) income before share of other comprehensive loss in joint venture | | | (64) | | | 130 | | | (142) | | | 232 | | | |
Share of other comprehensive loss in joint venture | | | (73) | | | (444) | | | (103) | | | (700) | | | |
Other comprehensive loss | | | (137) | | | (314) | | | (245) | | | (468) | | | |
| | | | | | | | | | | |
Total comprehensive loss | | | $ | (36,681) | | | $ | (49,236) | | | $ | (83,395) | | | $ | (108,764) | | | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY (DEFICIT)
(Unaudited)
For the Three and Six Months Ended June 30, 2024
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
(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 | |
April 1, 2024 | | | 89,041,946 | | | $ | 7,312 | | | $ | 1,181,020 | | | (6,264,720) | | | $ | (502) | | | $ | (201) | | | $ | (1,382,078) | | | $ | (194,449) | | |
Loss for the period | | | — | | | — | | | — | | | — | | | — | | | — | | | (36,544) | | | (36,544) | | |
Remeasurement of defined benefit pension liability | | | — | | | — | | | — | | | — | | | — | | | (81) | | | — | | | (81) | | |
Foreign currency translation adjustment | | | — | | | — | | | — | | | — | | | — | | | 17 | | | — | | | 17 | | |
Other comprehensive loss before share of other comprehensive loss in joint venture | | | — | | | — | | | — | | | — | | | — | | | (64) | | | — | | | (64) | | |
Share of other comprehensive loss in joint venture | | | — | | | — | | | — | | | — | | | — | | | (73) | | | — | | | (73) | | |
Total other comprehensive loss | | | — | | | — | | | — | | | — | | | — | | | (137) | | | — | | | (137) | | |
Total comprehensive loss for the period | | | — | | | — | | | — | | | — | | | — | | | (137) | | | (36,544) | | | (36,681) | | |
Vestings of RSUs | | | — | | | — | | | (22) | | | 254,899 | | | 22 | | | — | | | — | | | — | | |
Exercise of options | | | — | | | — | | | 40 | | | 25,604 | | | 1 | | | — | | | — | | | 41 | | |
| | | | | | | | | | | | | | | | | | |
Issuance of shares, underwritten offering, net of transaction costs | | | 10,411,912 | | | 921 | | | 59,345 | | | 3,000,000 | | | 240 | | | — | | | — | | | 60,506 | | |
Issuance of warrants, underwritten offering, net of transaction costs | | | — | | | — | | | 36,925 | | | — | | | — | | | — | | | — | | | 36,925 | | |
Share-based compensation expense | | | — | | | — | | | 1,988 | | | — | | | — | | | — | | | — | | | 1,988 | | |
| | | 10,411,912 | | | 921 | | | 98,276 | | | 3,280,503 | | | 263 | | | — | | | — | | | 99,460 | | |
June 30, 2024 | | | 99,453,858 | | | $ | 8,233 | | | $ | 1,279,296 | | | (2,984,217) | | | $ | (239) | | | $ | (338) | | | $ | (1,418,622) | | | $ | (131,670) | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | |
(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 | | | 89,041,946 | | | $ | 7,312 | | | $ | 1,180,545 | | | (6,748,809) | | | $ | (541) | | | $ | (93) | | | $ | (1,335,472) | | | $ | (148,249) | | |
Loss for the period | | | — | | | — | | | — | | | — | | | — | | | — | | | (83,150) | | | (83,150) | | |
Remeasurement of defined benefit pension liability | | | — | | | — | | | — | | | — | | | — | | | (81) | | | — | | | (81) | | |
Foreign currency translation adjustment | | | — | | | — | | | — | | | — | | | — | | | (61) | | | — | | | (61) | | |
Other comprehensive loss before share of other comprehensive loss in joint venture | | | — | | | — | | | — | | | — | | | — | | | (142) | | | — | | | (142) | | |
Share of other comprehensive loss in joint venture | | | — | | | — | | | — | | | — | | | — | | | (103) | | | — | | | (103) | | |
Total other comprehensive loss | | | — | | | — | | | — | | | — | | | — | | | (245) | | | — | | | (245) | | |
Total comprehensive loss for the period | | | — | | | — | | | — | | | — | | | — | | | (245) | | | (83,150) | | | (83,395) | | |
| | | | | | | | | | | | | | | | | | |
Vestings of RSUs | | | — | | | — | | | (42) | | | 502,929 | | | 42 | | | — | | | — | | | — | | |
Exercise of options | | | — | | | — | | | 72 | | | 31,988 | | | 2 | | | — | | | — | | | 74 | | |
Issuance of shares, 2022 Employee Stock Purchase Plan | | | — | | | — | | | 305 | | | 229,675 | | | 18 | | | — | | | — | | | 323 | | |
Issuance of shares, underwritten offering, net of transaction costs | | | 10,411,912 | | | 921 | | | 59,345 | | | 3,000,000 | | | 240 | | | — | | | — | | | 60,506 | | |
Issuance of warrants, underwritten offering, net of transaction costs | | | — | | | — | | | 36,925 | | | — | | | — | | | — | | | — | | | 36,925 | | |
Share-based compensation expense | | | — | | | — | | | 2,146 | | | — | | | — | | | — | | | — | | | 2,146 | | |
| | | 10,411,912 | | | 921 | | | 98,751 | | | 3,764,592 | | | 302 | | | — | | | — | | | 99,974 | | |
June 30, 2024 | | | 99,453,858 | | | $ | 8,233 | | | $ | 1,279,296 | | | (2,984,217) | | | $ | (239) | | | $ | (338) | | | $ | (1,418,622) | | | $ | (131,670) | | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY (DEFICIT)
(Unaudited)
For the Three and Six Months Ended June 30, 2023
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
(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 | |
April 1, 2023 | | | 89,041,946 | | | $ | 7,312 | | | $ | 1,174,879 | | | (8,014,180) | | | $ | (645) | | | $ | 1,669 | | | $ | (1,154,793) | | | $ | 28,422 | | |
Loss for the period | | | — | | | — | | | — | | | — | | | — | | | — | | | (48,922) | | | (48,922) | | |
Remeasurement of defined benefit pension liability | | | — | | | — | | | — | | | — | | | — | | | (40) | | | — | | | (40) | | |
Foreign currency translation adjustment | | | — | | | — | | | — | | | — | | | — | | | 170 | | | — | | | 170 | | |
Other comprehensive income before share of other comprehensive loss in joint venture | | | — | | | — | | | — | | | — | | | — | | | 130 | | | — | | | 130 | | |
Share of other comprehensive loss in joint venture | | | — | | | — | | | — | | | — | | | — | | | (444) | | | — | | | (444) | | |
Total other comprehensive loss | | | — | | | — | | | — | | | — | | | — | | | (314) | | | — | | | (314) | | |
Total comprehensive loss for the period | | | — | | | — | | | — | | | — | | | — | | | (314) | | | (48,922) | | | (49,236) | | |
Vestings of RSUs | | | — | | | — | | | (88) | | | 1,014,215 | | | 88 | | | — | | | — | | | — | | |
Share-based compensation expense | | | — | | | — | | | 1,118 | | | — | | | — | | | — | | | — | | | 1,118 | | |
| | | — | | | — | | | 1,030 | | | 1,014,215 | | | 88 | | | — | | | — | | | 1,118 | | |
June 30, 2023 | | | 89,041,946 | | | $ | 7,312 | | | $ | 1,175,909 | | | (6,999,965) | | | $ | (557) | | | $ | 1,355 | | | $ | (1,203,715) | | | $ | (19,696) | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | |
(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, 2023 | | | 89,041,946 | | | $ | 7,312 | | | $ | 1,166,414 | | | (8,399,419) | | | $ | (679) | | | $ | 1,823 | | | $ | (1,095,419) | | | $ | 79,451 | | |
Loss for the period | | | — | | | — | | | — | | | — | | | — | | | — | | | (108,296) | | | (108,296) | | |
Remeasurement of defined benefit pension liability | | | — | | | — | | | — | | | — | | | — | | | (79) | | | — | | | (79) | | |
Foreign currency translation adjustment | | | — | | | — | | | — | | | — | | | — | | | 311 | | | — | | | 311 | | |
Other comprehensive income before share of other comprehensive loss in joint venture | | | — | | | — | | | — | | | — | | | — | | | 232 | | | — | | | 232 | | |
Share of other comprehensive loss in joint venture | | | — | | | — | | | — | | | — | | | — | | | (700) | | | — | | | (700) | | |
Total other comprehensive loss | | | — | | | — | | | — | | | — | | | — | | | (468) | | | — | | | (468) | | |
Total comprehensive loss for the period | | | — | | | — | | | — | | | — | | | — | | | (468) | | | (108,296) | | | (108,764) | | |
| | | | | | | | | | | | | | | | | | |
Vestings of RSUs | | | — | | | — | | | (111) | | | 1,269,106 | | | 111 | | | — | | | — | | | — | | |
Issuance of shares, 2022 Employee Stock Purchase Plan | | | — | | | — | | | 414 | | | 130,348 | | | 11 | | | — | | | — | | | 425 | | |
Share-based compensation expense | | | — | | | — | | | 9,192 | | | — | | | — | | | — | | | — | | | 9,192 | | |
| | | — | | | — | | | 9,495 | | | 1,399,454 | | | 122 | | | — | | | — | | | 9,617 | | |
June 30, 2023 | | | 89,041,946 | | | $ | 7,312 | | | $ | 1,175,909 | | | (6,999,965) | | | $ | (557) | | | $ | 1,355 | | | $ | (1,203,715) | | | $ | (19,696) | | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(in thousands)
| | | | | | | | | | | | | |
| For the Six Months Ended June 30, |
| 2024 | | 2023 | | |
Cash used in operating activities | | | | | |
Net loss | $ | (83,150) | | | $ | (108,296) | | | |
Adjustments to reconcile net loss to net cash used in operations: | | | | | |
Deferred income taxes | — | | | (5,172) | | | |
Share-based compensation expense | 2,146 | | | 9,192 | | | |
Accretion expense of deferred royalty obligation | 13,790 | | | 5,346 | | | |
Amortization of debt discount, senior secured term loan | 943 | | | 1,503 | | | |
Cumulative catch-up adjustment, deferred royalty obligation | (526) | | | 5,288 | | | |
Write-downs of inventory | 1,036 | | | 780 | | | |
Depreciation | 657 | | | 536 | | | |
| | | | | |
Amortization of operating lease right-of-use assets | 1,024 | | | 999 | | | |
| | | | | |
Share of results in joint venture | 1,284 | | | 2,130 | | | |
| | | | | |
| | | | | |
Warrant obligations, increase (decrease) in fair value | 838 | | | (636) | | | |
| | | | | |
| | | | | |
Other | (240) | | | 18 | | | |
Changes in operating assets and liabilities: | | | | | |
Accounts receivable, net | 2,314 | | | 49,089 | | | |
Inventory | (50) | | | (2,400) | | | |
Other current assets | (859) | | | 4,930 | | | |
Other long-term assets | (287) | | | 200 | | | |
Accounts payable | (6,083) | | | (687) | | | |
Accrued expenses and other short-term liabilities | (5,732) | | | (15,588) | | | |
| | | | | |
Operating lease liabilities | (1,028) | | | (714) | | | |
Other long-term liabilities | (3,017) | | | 3,102 | | | |
Net cash used in operating activities | (76,940) | | | (50,380) | | | |
Cash flows from investing activities | | | | | |
Payment for purchases of property and equipment | (561) | | | (2,228) | | | |
Net cash used in investing activities | (561) | | | (2,228) | | | |
Cash flows provided by financing activities | | | | | |
Proceeds from common shares, 2024 Equity Offering, net of transaction costs | 61,731 | | | — | | | |
Proceeds from 2024 Pre-Funded Warrants, net of transaction costs | 36,925 | | | — | | | |
Proceeds from deferred royalty transaction, net of transaction costs | — | | | 73,102 | | | |
Proceeds from share issuance under stock purchase plan | 323 | | | 425 | | | |
Proceeds from the exercise of stock options | 74 | | | — | | | |
Net cash provided by financing activities | 99,053 | | | 73,527 | | | |
Net increase in cash and cash equivalents | 21,552 | | | 20,919 | | | |
Exchange (losses)/gains on cash and cash equivalents | (31) | | | 150 | | | |
Cash and cash equivalents at beginning of period | 278,598 | | | 326,441 | | | |
Cash and cash equivalents at end of period | $ | 300,119 | | | $ | 347,510 | | | |
Supplemental Cash Flow Information: | | | | | |
Interest paid | $ | 7,874 | | | $ | 7,522 | | | |
Interest received | 7,635 | | | 5,167 | | | |
Payments made under royalty financing transaction | 2,569 | | | 6,230 | | | |
| | | | | |
Supplemental Non-Cash Investing and Financing Activities: | | | | | |
Transaction costs recorded in Accounts payable and other current liabilities | 1,225 | | | — | | | |
Capital expenditures recorded in Accounts payable and Accrued expenses and other current liabilities | — | | | 270 | | | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
| | |
|
ADC Therapeutics SA |
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS |
(Unaudited) |
(in thousands, except per share amounts) |
1.Description of Business and Organization
ADC Therapeutics is a leading, commercial-stage global pioneer in the field of antibody drug conjugates (“ADCs”) committed to advancing its proprietary ADC technology platform to transform the 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 and targets, a robust next-generation research and development toolbox, and specialized end-to-end capabilities. The Company generates sales from its flagship product, ZYNLONTA, which is currently approved in the U.S. for the treatment of relapsed or refractory diffuse large B-cell lymphoma (“DLBCL”) in the third-line setting and has also been granted conditional marketing authorization in Europe. Additionally, the Company is seeking to expand ZYNLONTA into earlier lines of therapy and indolent lymphomas, and is committed to advancing its portfolio and pipeline through its continued research, development, regulatory and commercialization activities.
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 three wholly-owned subsidiaries: ADC Therapeutics America, Inc. (“ADCT America”), which was incorporated in Delaware, USA on December 10, 2014, ADC Therapeutics (UK) Ltd (“ADCT UK”), which was incorporated in England on December 12, 2014 and ADC Therapeutics (NL) B.V. which was incorporated in the Netherlands on February 25, 2022. The Company and its three 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 unaudited condensed consolidated subsidiaries unless otherwise indicated.
2.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, 2023.
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 and six months ended June 30, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024, 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, 2023.
The Company is managed and operated as one business segment, focused on the global development and commercialization of targeted ADC cancer therapies. A single management team that reports to the chief operating decision-maker, the Chief Executive Officer, comprehensively manages and allocates resources at the global corporate level. Accordingly, the Company views its business and manages its operations as a single operating segment.
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 unaudited condensed 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.
Going Concern
We are responsible for evaluating, and providing disclosure of uncertainties about, our ability to continue as a going concern. As of June 30, 2024, we had cash and cash equivalents of $300.1 million. Based on our evaluation, we concluded there is no substantial doubt about our ability to continue as a going concern within one year from the date the unaudited condensed consolidated financial statements were issued.
Recent Accounting Pronouncements
New accounting pronouncements which have been adopted
There are no accounting pronouncements that the Company has recently adopted.
Issued but not yet adopted
In November 2023, the FASB amended guidance in ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The revised guidance requires that a public entity disclose significant segment expenses regularly reviewed by the chief operating decision maker (CODM), including public entities with a single reportable segment. The amended guidance is effective for fiscal years beginning in January 2024 and interim periods beginning January 2025 on a retrospective basis. Early adoption is permitted. The Company is currently evaluating the effect that adoption of ASU 2023-07 will have on its consolidated financial statements.
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.
3.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. The estimated fair value of debt is based on Level 2 inputs, including our understanding of current market rates we could obtain for similar loans.
The Deerfield warrants, which are measured at fair value on a recurring basis, were as follows as of June 30, 2024 and December 31, 2023:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
(in thousands) | | Total | | Quoted prices in active markets for identical assets and liabilities (Level 1) | | Other observable inputs (Level 2) | | Significant unobservable inputs (Level 3) |
June 30, 2024: | | | | | | | | |
Deerfield warrant obligation | | $ | 1,134 | | | $ | — | | | $ | 1,134 | | | $ | — | |
| | | | | | | | |
Total | | $ | 1,134 | | | $ | — | | | $ | 1,134 | | | $ | — | |
| | | | | | | | | | | | | | | | | | | | | | | | | | |
(in thousands) | | Total | | Quoted prices in active markets for identical assets and liabilities (Level 1) | | Other observable inputs (Level 2) | | Significant unobservable inputs (Level 3) |
December 31, 2023: | | | | | | | | |
Deerfield warrant obligation | | $ | 296 | | | $ | — | | | $ | 296 | | | $ | — | |
| | | | | | | | |
Total | | $ | 296 | | | $ | — | | | $ | 296 | | | $ | — | |
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 10, "Deerfield warrants." A Black-Scholes model was used to calculate the fair values.
There were no transfers between the respective levels during the period.
4.Inventory
As of June 30, 2024 and December 31, 2023 inventory consisted of the following:
| | | | | | | | | | | | | | |
(in thousands) | | June 30, 2024 | | December 31, 2023 |
| | | | |
Work in progress | | $ | 15,123 | | | $ | 16,095 | |
Finished goods | | 68 | | | 82 | |
Total inventory, net | | $ | 15,191 | | | $ | 16,177 | |
Inventory write-downs of $288 and $1,036 were recognized for the three and six months ended June 30, 2024, respectively, and $727 and $780 were recognized for the three and six months ended June 30, 2023, respectively, and charged to cost of product sales in the Company’s unaudited condensed consolidated statements of operations.
5.Property and equipment
Property and equipment as of June 30, 2024 and December 31, 2023 consisted of the following:
| | | | | | | | | | | | | | |
(in thousands) | | June 30, 2024 | | December 31, 2023 |
Leasehold improvements | | $ | 3,905 | | | $ | 3,953 | |
Laboratory equipment | | 4,154 | | | 3,652 | |
Office equipment | | 977 | | | 1,119 | |
Hardware and computer software | | 1,138 | | | 1,173 | |
| | | | |
| | 10,174 | | | 9,897 | |
Less: accumulated depreciation | | (4,691) | | | (4,275) | |
Property and equipment, net | | $ | 5,483 | | | $ | 5,622 | |
Depreciation expense was $326 and $657 for the three and six months ended June 30, 2024, respectively, and $273 and $536 for the three and six months ended June 30, 2023, respectively.
6.Interest in joint venture
On December 14, 2020, the Company formed a new joint venture company, Overland ADCT BioPharma, with Overland Pharmaceuticals (“Overland”) to develop and commercialize ZYNLONTA, and three of the Company’s ADC product candidates, ADCT-601, ADCT-602 and ADCT-901 (collectively, the “Licensed Products”), in greater China and Singapore (the “Territory”).
The table below provides a rollforward of the Company’s interest in Overland ADCT BioPharma as of June 30, 2024 and December 31, 2023.
| | | | | | | | |
(in thousands) | | |
Interest in joint venture | | |
January 1, 2023 | | $ | 7,613 | |
Share of comprehensive loss in joint venture | | (5,966) | |
December 31, 2023 | | $ | 1,647 | |
Share of comprehensive loss in joint venture | | (1,387) | |
June 30, 2024 | | $ | 260 | |
7.Income taxes
Income tax expense for the three and six months ended June 30, 2024 was $0.2 million and $0.4 million, respectively, relative to loss before income taxes of $35.7 million and $81.5 million, respectively. The income tax benefit for the three and six months ended June 30, 2023 was $4.5 million and $4.0 million, respectively, relative to loss before income taxes of $52.7 million and $110.1 million, respectively. The expense for the three and six months ended June 30, 2024 is 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. Whereas the benefit for the three and six months ended June 30, 2023 was the result of income generated in the U.S. and UK. The decrease in income for the US operations is due to a change in the Company operating and transfer pricing model which was implemented in October 2023. 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.
8.Accrued expenses and other current liabilities
Accrued expenses and other current liabilities consist of the following:
| | | | | | | | | | | | | | |
(in thousands) | | June 30, 2024 | | December 31, 2023 |
Accrued R&D costs | | $ | 18,304 | | | $ | 24,902 | |
Accrued payroll and benefits | | 8,088 | | | 12,693 | |
| | | | |
Gross-to-net sales adjustments, short-term | | 8,180 | | | 1,543 | |
Operating lease liabilities, short-term | | 1,415 | | | 1,467 | |
Other | | 10,937 | | | 11,496 | |
| | $ | 46,924 | | | $ | 52,101 | |
9.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 and six months ended June 30, 2024, the Company recorded interest expense on the senior secured term loan in the amount of $4,413 and $8,816, respectively, and $4,480 and $9,020 for the three and six months ended June 30, 2023, respectively, which was recorded in interest expense in the unaudited condensed consolidated statements of operations. The effective interest rate (“EIR”) at June 30, 2024 was 16.83%.
The following table provides a summary of the interest expense for the Company’s senior secured term loan for the three months ended June 30, 2024 and 2023:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three months ended June 30, | | Six months ended June 30, |
| | 2024 | | 2023 | | 2024 | | 2023 |
Contractual interest expense | | $ | 3,973 | | | $ | 3,807 | | | $ | 7,873 | | | $ | 7,517 | |
Amortization of debt discount | | 440 | | | 673 | | | 943 | | | 1,503 | |
Total | | $ | 4,413 | | | $ | 4,480 | | | $ | 8,816 | | | $ | 9,020 | |
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 $113.7 million and $112.7 million as of June 30, 2024 and December 31, 2023, respectively.
Contractual payments due under our senior secured term loans, including exit fees are as follows (in thousands):
| | | | | | | | |
2024 (remainder) | | $ | — | |
2025 | | — | |
2026 | | 3,090 | |
2027 | | 9,330 | |
2028 | | 12,480 | |
Thereafter | | 99,840 | |
Total | | $ | 124,740 | |
10.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 (gains or losses) of the warrant obligation at the end of each period are recorded in the unaudited condensed consolidated statements of operations.
During the three and six months ended June 30, 2024, the Company recognized income (expense) of $2,230 and $(838), respectively, and $20 and $636 for the three and six months ended June 30, 2023, respectively, as a result of changes in the fair value of the warrant obligation. The fair value of the warrant obligation as of June 30, 2024 and December 31, 2023 was $1,134 and $296, respectively. The increase in fair value of the warrant obligation from December 31, 2023 to June 30, 2024 was primarily due to the increase in the fair value of the underlying shares during the respective period. This amount was recorded to Other, net in the unaudited condensed consolidated statements of operations. See note 16, "Other income (expense)" for further information.
The Company used a third-party valuation firm to assist in calculating the fair value of the Deerfield warrant obligation, using the Black-Scholes option-pricing model. Key inputs for the valuation of the warrant obligation as of June 30, 2024 and December 31, 2023 were as follows:
| | | | | | | | | | | |
| As of | | As of |
| June 30, 2024 | | December 31, 2023 |
Exercise price in $ | 24.70 and 28.07 | | 24.70 and 28.07 |
Share price in $ | 3.16 | | | 1.66 | |
Risk-free interest rate | 5.1 | % | | 4.6 | % |
Expected volatility | 140.6 | % | | 116.0 | % |
Expected term (months) | 10.7 months | | 16.7 months |
Dividend yield | — | | | — | |
Black-Scholes value in $ | 0.27 and 0.23 | | 0.07 and 0.06 |
11.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.
| | | | | | | | |
(in thousands) | | |
Liability balance at January 1, 2023 | | $ | 222,277 | |
Plus: Additional proceeds from the sale of future royalties | | 75,000 | |
Less: Transaction costs | | 1,898 | |
Less: royalty payments | | 8,709 | |
Plus: interest expense | | 27,915 | |
Less: cumulative catch-up adjustment, Other, net | | 4,972 | |
Liability balance at December 31, 2023 | | 309,613 | |
| | |
Less: royalty payments | | 2,569 | |
Plus: interest expense | | 16,359 | |
Less: cumulative catch-up adjustment, Other, net | | 526 | |
Liability balance at June 30, 2024 | | $ | 322,877 | |
12.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 and six months ended June 30, 2024 and 2023 is as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three months ended June 30, | | Six months ended June 30, |
(in thousands) | | 2024 | | 2023 | | 2024 | | 2023 |
Net periodic benefit cost: | | | | | | | | |
Service cost | | $ | 183 | | | $ | 275 | | | $ | 347 | | | $ | 447 | |
Interest cost | | 37 | | | 75 | | | 75 | | | 149 | |
Expected return on plan assets | | (59) | | | (83) | | | (118) | | | (165) | |
Amortization of prior service cost | | (40) | | | (40) | | | (81) | | | (79) | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
Net periodic benefit cost | | $ | 121 | | | $ | 227 | | | $ | 223 | | | $ | 352 | |
The components of net periodic benefit cost are included in operating expense on the unaudited condensed consolidated statements of operations.
13.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, 2023.
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 unaudited condensed consolidated financial condition, liquidity, or results of operation.
14.Shareholders’ equity
2024 Equity Offering
In May 2024, the Company completed an underwritten offering of equity securities in which 13,411,912 of the Company’s common shares were sold to public investors at a price of $4.90 per share and pre-funded warrants (the “2024 Pre-Funded Warrants”) to purchase 8,163,265 of the Company’s common shares were sold to public investors at a price of $4.81 per pre-funded warrant, which equals the per share 2024 Equity Offering price, less the CHF 0.08 exercise price for each pre-funded warrant (collectively, the “2024 Equity Offering”). Gross proceeds from the 2024 Equity Offering were approximately $105.0 million, and, after giving effect to $7.6 million of transaction costs related to the offering, net proceeds were approximately $97.4 million.
The 2024 Pre-Funded Warrants are exercisable, on a cash basis (or, if there is no registration statement and current prospectus covering the issuance of the shares upon exercise, then on a cashless basis), at the option of the holder after the date of issuance until the tenth anniversary of their original issuance. At any time during the last 90 days of the term, the holder may exchange the Pre-Funded Warrant for, and we will issue, a new pre-funded warrant for the number of common shares then remaining under the Pre-Funded Warrant. The Pre-Funded Warrants have certain limitations on exercise, including (i) any exercise must be for at least 50,000 common shares (or, if less, the remaining common shares available for purchase under the Pre-Funded Warrants), (ii) a holder cannot exercise for any amount that would cause such holder’s beneficial ownership of our common shares to exceed 9.99% (or 19.99% with 61-days’ notice to us), and (iii) cashless exercise is not available in certain circumstances as specified in the Pre-Funded Warrants. The warrants contain customary anti-dilution adjustments and will entitle holders to receive any dividends or other distributions paid on the underlying common shares prior to their expiration on an as-exercised basis.
Accounting for the 2024 Equity Offering and Pre-Funded Warrants
The Company has accounted for the common shares and 2024 Pre-funded Warrants described above each as freestanding financial instruments.
The common shares were issued from the Company’s share capital and treasury shares at par value. The common shares were recorded as $60.5 million to equity for the issuance of the common shares, net of transaction costs accrued and paid, and an increase in cash and cash equivalents.
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, including the warrant holders cannot require “net cash settlement” in a circumstance outside of the Company’s control, and there is sufficient authorized and unissued shares to settle the warrants. Accordingly, these warrants are recognized as $36.9 million in equity and accounted for as a component of additional paid-in capital at the time of issuance, net of transaction costs paid, and an increase in cash and cash equivalents.
Transaction costs have been allocated to the warrants and the common shares based on the relative fair value method. Transaction costs associated to the warrants and common shares have been deducted from the respective instrument in equity.
15.Revenue
The table below provides a disaggregation of revenues by type and customer location for the three and six months ended June 30, 2024 and 2023:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three months ended June 30, | | Six months ended June 30, |
(in thousands) | | 2024 | | 2023 | | 2024 | | 2023 |
Types of goods and services | | | | | | | | |
Product revenue, net | | $ | 17,030 | | | $ | 19,197 | | | $ | 34,878 | | | $ | 38,150 | |
| | | | | | | | |
Royalties | | 380 | | | 86 | | | 585 | | | 125 | |
Total revenue | | $ | 17,410 | | | $ | 19,283 | | | $ | 35,463 | | | $ | 38,275 | |
| | | | | | | | |
Customer Location | | | | | | | | |
U.S. | | $ | 17,030 | | | $ | 19,197 | | | $ | 34,878 | | | $ | 38,150 | |
EMEA(1) | | 380 | | | 86 | | | 585 | | | 125 | |
| | | | | | | | |
Total revenue | | $ | 17,410 | | | $ | 19,283 | | | $ | 35,463 | | | $ | 38,275 | |
(1) Europe, the Middle East and Africa
Product revenue, net
The table below provides a rollforward of the Company’s accruals related to the GTN sales adjustments for the three and six months ended June 30, 2024:
| | | | | | | | | | | | | | | | | | | | |
(in thousands) | | Discarded Drug Rebate | | Other Adjustments | | Total |
Balance as of April 1, 2024 | | $ | 9,393 | | | $ | 3,768 | | | $ | 13,161 | |
GTN accruals for current period | | 1,858 | | | 3,759 | | | 5,617 | |
Prior period adjustments | | — | | | (791) | | | (791) | |
Credits, payments and reclassifications | | — | | | (3,479) | | | (3,479) | |
Balance as of June 30, 2024 | | $ | 11,251 | | | $ | 3,257 | | | $ | 14,508 | |
| | | | | | |
Balance as of January 1, 2024 | | $ | 7,391 | | | $ | 3,946 | | | $ | 11,337 | |
GTN accruals for current period | | 3,904 | | | 8,217 | | | 12,121 | |
Prior period adjustments | | (44) | | | (1,020) | | | (1,064) | |
Credits, payments and reclassifications | | — | | | (7,886) | | | (7,886) | |
Balance as of June 30, 2024 | | $ | 11,251 | | | $ | 3,257 | | | $ | 14,508 | |
The table below provides a rollforward of the Company’s accruals related to the GTN sales adjustments for the three and six months ended June 30, 2023:
| | | | | | | | | | | | | | | | | | | | |
(in thousands) | | Discarded Drug Rebate | | Other Adjustments | | Total |
Balance as of April 1, 2023 | | $ | 1,316 | | | $ | 3,046 | | | $ | 4,362 | |
GTN accruals for current period | | 1,485 | | | 4,298 | | | 5,783 | |
Prior period adjustments | | — | | | (229) | | | (229) | |
Credits, payments and reclassifications | | — | | | (4,182) | | | (4,182) | |
Balance as of June 30, 2023 | | $ | 2,801 | | | $ | 2,933 | | | $ | 5,734 | |
| | | | | | |
Balance as of January 1, 2023 | | $ | — | | | $ | 3,746 | | | $ | 3,746 | |
GTN accruals for current period | | 2,801 | | | 8,598 | | | 11,399 | |
Prior period adjustments | | — | | | (877) | | | (877) | |
Credits, payments and reclassifications | | — | | | (8,534) | | | (8,534) | |
Balance as of June 30, 2023 | | $ | 2,801 | | | $ | 2,933 | | | $ | 5,734 | |
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 June 30, 2024 and December 31, 2023.
| | | | | | | | | | | | | | |
(in thousands) | | June 30, 2024 | | December 31, 2023 |
Accounts receivable, net | | $ | 2,424 | | | $ | 2,403 | |
Other current and non-current liabilities | | 12,084 | | | 8,934 | |
| | $ | 14,508 | | | $ | 11,337 | |
Customers from which we derive more than 10% of our total product revenues for the three and six months ended June 30, 2024 and 2023 are as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three months ended June 30, | | Six months ended June 30, |
| | 2024 | | 2023 | | 2024 | | 2023 |
McKesson | | 37 | % | | 38 | % | | 40 | % | | 38 | % |
AmerisourceBergen Corporation | | 35 | % | | 37 | % | | 36 | % | | 37 | % |
Cardinal Health | | 28 | % | | 25 | % | | 24 | % | | 25 | % |
16.Other income (expense)
Interest Income
Interest income includes interest received from banks on our cash balances. Interest income was $3.3 million and $6.2 million for the three and six months ended June 30, 2024, respectively, and $2.4 million and $4.5 million for the three and six months ended June 30, 2023, respectively.
Interest Expense
The components of Interest expense for the three and six months ended June 30, 2024 and 2023 are as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | Three months ended June 30, | | Six months ended June 30, |
(in thousands) | | | | | | | | 2024 | | 2023 | | 2024 | | 2023 |
| | | | | | | | | | | | | | |
Deferred royalty obligation interest expense | | | | | | | | $ | 8,266 | | | $ | 5,829 | | | $ | 16,359 | | | $ | 11,575 | |
Effective interest expense on senior secured term loan facility | | | | | | | | 4,413 | | | 4,480 | | | 8,816 | | | 9,020 | |
Other interest expense | | | | | | | | — | | | — | | | — | | | 5 | |
Interest expense | | | | | | | | $ | 12,679 | | | $ | 10,309 | | | $ | 25,175 | | | $ | 20,600 | |
Other, net
The components of Other, net for the three and six months ended June 30, 2024 and 2023 are as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | Three months ended June 30, | | Six months ended June 30, |
(in thousands) | | | | 2024 | | 2023 | | 2024 | | 2023 |
Deerfield warrant obligation, change in fair value income (expense) | | | | $ | 2,230 | | | $ | 20 | | | $ | (838) | | | $ | 636 | |
Cumulative catch-up adjustment income (expense), deferred royalty obligation | | | | 263 | | | (5,417) | | | 526 | | | (5,288) | |
| | | | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |
Exchange differences (loss) gain | | | | (59) | | | 15 | | | (96) | | | (37) | |
R&D tax credit | | | | 320 | | | 315 | | | 567 | | | 455 | |
Other, net | | | | $ | 2,754 | | | $ | (5,067) | | | $ | 159 | | | $ | (4,234) | |
17.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 June 30, 2024, the Company has 4,806,185 common shares available for the future issuance of share-based equity awards.
As of June 30, 2024 and December 31, 2023, 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 $157,773 and $157,906, respectively. The amounts of expense (reversal) recognized for all awards for services received during the three and six months ended June 30, 2024 were $848 and $(133), respectively, and $1,010 and $8,987 during the three and six months ended June 30, 2023, respectively.
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. As of June 30, 2024, the Company has 2,833,459 common shares available for the future issuance of share-based equity awards.
As of June 30, 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 $2,357. The amounts of expense for all awards recognized for services received during the three and six months ended June 30, 2024 was $975 and $2,038, respectively.
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 June 30, 2024, the Company has 688,800 common shares available for the future issuance of share-based equity awards under this plan.
As of June 30, 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 $95. The amounts of expense for all awards recognized for services received during the three and six months ended June 30, 2024 was $95 under this plan.
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 and six months ended June 30, 2024 was $689 and $(745), respectively, and $(715) and $4,066 during the three and six months ended June 30, 2023, respectively.
Movements in the number of awards outstanding under the Plans described above and their related weighted average strike prices are as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | 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, 2023 | | $11.00 | | 10,744,406 | | | 8.14 | | $ | — | |
Granted | | 3.83 | | 540,400 | | | | | |
Forfeited | | 10.50 | | (428,200) | | | | | |
Expired | | 32.53 | | (866,595) | | | | | |
Exercised | | 2.62 | | (31,988) | | | | | |
Outstanding as of June 30, 2024 | | $9.23 | | 9,958,023 | | | 7.77 | | $ | — | |
As of June 30, 2024, 4,910,379 awards are vested and exercisable out of the total outstanding awards of 9,958,023 common shares. As of June 30, 2024, the weighted average strike price and weighted average remaining life for vested and exercisable awards is $14.18 and 6.93 years, respectively. Awards outstanding as of June 30, 2024 have expiration dates through 2034. The weighted average grant date fair value of the awards granted during the six months ended June 30, 2024 was $3.02. The aggregate intrinsic value of vested and exercisable options was zero. As of June 30, 2024, the unrecognized compensation cost related to 5,047,644 unvested share options expected to vest was $9.8 million. This unrecognized cost will be recognized over an estimated weighted-average amortization period of 1.53 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 Company used a third-party valuation firm to assist in calculating the fair value of the award grants per participant.
The fair values of the options granted during the three and six months ended June 30, 2024 and 2023 were determined on the date of grant using the following assumptions:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | Three months ended June 30, | | Six months ended June 30, |
| | | | 2024 | | 2023 | | 2024 | | 2023 |
Share price, in $ | | | | 3.31-4.71 | | 1.96-2.38 | | 1.69-4.86 | | 1.96-5.45 |
Strike price, in $ | | | | 3.31-4.71 | | 1.96-2.38 | | 1.69-4.86 | | 1.96-5.45 |
Expected volatility, in % | | | | 95 | | 75-80 | | 95 | | | 75-80 |
Award life, in years | | | | 6.08 | | 6.08 | | 6.08 | | 6.08 |
Expected dividends | | | | — | | | — | | | — | | | — | |
Risk-free interest rate, in % | | | | 4.24-4.54 | | 3.56-4.02 | | 3.75-4.54 | | 3.39-4.13 |
During the three and six months ended June 30, 2023, the expected volatility was based on the Company’s historical volatility and selected volatility determined by median values observed among other comparable public companies. Beginning in the third quarter of 2023, the Company’s expected volatility is no longer determined by values observed among other comparable companies and is now based on the Company’s historical volatility. 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 two 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 and six months ended
June 30, 2024 is $1,229 and $2,745, respectively, and $1,725 and $4,921 during the three and six months ended June 30, 2023, respectively.
The following table summarizes the RSU awards outstanding as of June 30, 2024:
| | | | | | | | | | | |
| Number of awards | | Weighted average grant date fair value (in $ per share) |
| | | |
| | | |
| | | |
| | | |
December 31, 2023 | 6,533,843 | | | $2.03 |
Granted | 280,000 | | | 3.16 |
Vested | (502,929) | | | 9.17 |
Forfeited | (521,038) | | | 1.88 |
June 30, 2024 (1) | 5,789,876 | | | $1.48 |
(1) Includes 5,166,541 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 six months ended June 30, 2024 was $2.1 million.
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 expense recognized related to the ESPP during the three and six months ended June 30, 2024 is $70 and $146, respectively, and $108 and $205 during the three and six months ended June 30, 2023, respectively.
18.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 and pre-funded warrants outstanding during the period, excluding common shares owned by the Company and held as treasury shares, as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three months ended June 30, | | Six months ended June 30, | | |
(in thousands, except per share amounts) | | 2024 | | 2023 | | 2024 | | 2023 | | |
Net loss | | $ | (36,544) | | | $ | (48,922) | | | $ | (83,150) | | | $ | (108,296) | | | |
Weighted average number of shares outstanding | | 95,691,245 | | | 81,471,127 | | | 89,121,783 | | | 81,140,287 | | | |
Basic and diluted loss per share | | $ | (0.38) | | | $ | (0.60) | | | $ | (0.93) | | | $ | (1.33) | | | |
For the three and six months ended June 30, 2024 and 2023, basic and diluted loss per share is calculated on the weighted average number of shares issued and outstanding and excludes shares to be issued under the Equity Incentive Plan 2019, Conditional Share Capital Plan, Inducement Plan, the Company’s warrant agreements and 2022 ESPP as the effect of including those shares would be anti-dilutive. See note 9, “Senior secured term loan facility,” note 10, “Deerfield warrants”, note 14, “Shareholders’ equity”, and note 17, “Share-based compensation expense,” 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: | | | | | | | | | | | | | | | | |
| | Six months ended June 30, | | |
| | 2024 | | 2023 | | |
2019 Equity Incentive Plan - Share Options | | 9,269,223 | | | 11,293,279 | | | |
Inducement Plan - Share Options | | 688,800 | | | — | | | |
2019 Equity Incentive Plan - RSUs | | 623,335 | | | 1,108,899 | | | |
Conditional Share Capital Plan - RSUs | | 5,166,541 | | | — | | | |
Outstanding warrants | | 4,940,135 | | | 4,940,135 | | | |
| | | | | | |
| | 20,688,034 | | | 17,342,313 | | | |
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements, including the notes thereto, included in this Quarterly Report, as well as our audited consolidated financial statements, including the notes thereto, included in our Annual Report on Form 10-K. The following discussion includes forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those anticipated in these forward-looking statements. See “Forward-Looking Statements.”
Business Overview
ADC Therapeutics is a leading, commercial-stage global pioneer in the field of antibody drug conjugates (“ADCs”).
Our goal is to be a leading ADC company that transforms the lives of those impacted by cancer. To achieve this, we are focused on unlocking the potential value of our robust ADC portfolio across two pillars of growth: hematology and solid tumors. We are a pioneer in the ADC field with specialized end-to-end capabilities unique to ADCs including a validated technology platform, a growing next-generation research & development toolbox and a proven track record that includes an approved and marketed product. We aim to expand our portfolio and accelerate the development of our pipeline through targeted investments and in collaboration with strategic partners. In this way, we plan to pursue multiple targets in parallel, enabling us to prioritize and ensure a disciplined capital allocation strategy while advancing the most promising candidates in both hematologic and solid tumors.
In the hematology space, our flagship product, ZYNLONTA, a CD19-directed ADC, received accelerated approval from the U.S. Food and Drug Administration (“FDA”) and conditional approval from the European Commission for the treatment of relapsed or refractory diffuse large B-cell lymphoma (“DLBCL”) after two or more lines of systemic therapy. We have a direct commercialization model in the US to help drive growth of ZYNLONTA. Outside the US, we continue to advance the development and commercialization of ZYNLONTA through strategic partnerships. We are seeking to continue expanding ZYNLONTA internationally, and into earlier lines of DLBCL and other indolent lymphomas, including follicular lymphoma (“FL”) and marginal zone lymphoma (“MZL”) as a single and combination agent of choice through our LOTIS-5 confirmatory Phase 3 clinical trial and LOTIS-7 Phase1b clinical trial as well as through investigator-initiated trials (“IITs”) at leading institutions. In addition, we are investigating a CD-22 targeted compound, ADCT-602, in a Phase 1/2 investigator-initiated study in relapsed or refractory B-cell acute lymphoblastic leukemia.
In the solid tumor space, our clinical-stage pipeline consists of ADCT-601 (mipasetamab uzoptirine) targeting AXL as a single agent and/or in combination in sarcoma, pancreatic, and NSCLC. Our pre-clinical stage pipeline includes a portfolio of next generation investigational ADCs targeting Claudin-6, NaPi2b, PSMA and ASCT2. Investigational New Drug (IND) enabling studies are in progress for ADC targeting NaPi2b and Claudin-6 programs while PSMA and ASCT2 targeting ADCs are in drug candidate selection stage and are expected to be completed this year. In addition, we are advancing research with a range of payloads, linkers and conjugation technologies against undisclosed targets.
Recent Developments
Hematology
In April 2024, the Company provided an update on the progress of the LOTIS-7 trial in hematology and on its technology platform capabilities, research and development activities and pipeline in the solid tumor space. In addition, in May 2024, IIT data was presented on ZYNLONTA in MZL.
LOTIS-7
On April 4, 2024, The Company announced the completion of dose escalation in LOTIS-7, a Phase 1b open-label clinical trial evaluating ZYNLONTA® (loncastuximab tesirine-lpyl) in combination with bispecific antibodies glofitamab or mosunetuzumab in heavily pre-treated patients with relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL).
In the dose escalation portion (Part 1) of LOTIS-7, no dose-limiting toxicities (“DLTs”), no or low-grade cytokine release syndrome (“CRS”) and no immune effector cell-associated neurotoxicity syndrome (“ICANS”) were observed across all patients when ZYNLONTA was administered in combination with glofitamab or mosunetuzumab. Additionally, after the first investigator assessment, evidence of anti-tumor activity (complete response or partial response) was observed among the majority of patients, with mixed histologies including DLBCL, follicular lymphoma (“FL”) and marginal zone
lymphoma (“MZL”). In addition, as of April 19, 2024, initial safety findings showed that the majority of CRS events seen were grade 1 (6 out of 18 patients) or grade 2 (2 of 18 patients), with no CRS greater than grade 2 observed in either combination arm. Furthermore, all grade 2 events responded to Tocilizumab/corticosteroids with no requirement for pressors or ICU management. Based on the data from Part 1, all three dose levels (90, 120 and 150 µg/kg) have now been cleared and enrollment in Part 2 dose expansion is ongoing with ZYNLONTA administered in combination with glofitamab at the 120 µg/kg and 150 µg/kg dose levels in 2L+ DLBCL.
The early data from Part 1 of the LOTIS-7 trial highlight the potential combinability of ZYNLONTA with bispecifics in lymphoma patients and continued progression of this trial in 2L+ DLBCL patients. The Company believes LOTIS-7 demonstrates the potential for ZYNLONTA plus bispecifics to enable broader accessibility in community settings, and based upon the current data and coupled with the potential for additive or synergistic efficacy with this combination, we are encouraged about the potential opportunity to expand the use of ZYNLONTA in DLBCL in the future where there remains high unmet need.
LOTIS-7 is a Phase 1b global multicenter, multi-arm study in patients with relapsed or refractory B-cell non-Hodgkin lymphoma including Part 1 (dose escalation) and Part 2 (dose expansion). The three dosing arms include ZYNLONTA plus polatuzumab vedotin, ZYNLONTA plus glofitamab, and ZYNLONTA plus mosunetuzumab T-cell-engaging bispecific monoclonal antibodies (“BsAbs”). Enrollment in LOTIS-7 includes Part 1 of the study with a 3+3 dose escalation in 3L/3L+ heavily pre-treated patients with ZYNLONTA doses starting at 90 µg/kg and then proceeding to 120 µg/kg and 150 µg/kg. The dose-limiting toxicity period has now been cleared across all three dose levels.
The following table sets forth the Grade 3 and Grade 4 adverse events (AE), regardless of relatedness, for the LOTIS-7 Part 1 dose escalation as of April 19, 2024:
| | | | | | | | | | | | | | | | | | | | |
Patients Treated | | Arm E (Lonca+Glofit) | | Arm F (Lonca+Mosun) | | Total |
| N=9 | | N=9 | | N=18 |
Patients with any Grade AE | | 9 (100%) | | 9 (100%) | | 18 (100%) |
Patients with any Grade 3/4 AE | | 3 (33.3%) | | 5 (55.5%) | | 8 (88.8%) |
Patients with Grade 3/4 Hematologic AE | | 2 (22.2%) | | 4 (44.4%) | | 6 (33.3%) |
Lymphopenia | | 1 (11.1%) | | 0 | | 1 (5.5%) |
Neutropenia | | 1 (11.1%) | | 3 (33.3%) | | 4 (22.2%) |
Thrombocytopenia | | 1 (11.1%) | | 0 | | 1 (5.5%) |
Anemia | | 0 | | 3 (33.3%) | | 3 (16.6%) |
Patients with Grade 3/4 Non-hematologic events | | 1 (11.1%) | | 3 (33.3%) | | 4 (22.2%) |
Hypertension worsened | | 1 (11.1%) | | 0 | | 1 (5.5%) |
Bronchiectasis | | 0 | | 1 (11.1%) | | 1 (5.5%) |
Bronchitis | | 0 | | 1 (11.1%) | | 1 (5.5%) |
Decompensation cardiac | | 0 | | 1 (11.1%) | | 1 (5.5%) |
Pneumonia pseudomonal | | 0 | | 1 (11.1%) | | 1 (5.5%) |
Sepsis | | 0 | | 1 (11.1%) | | 1 (5.5%) |
*A patient may have more than one adverse event.
The following table summarizes serious adverse events (SAE), regardless of relatedness, for the LOTIS-7 Part 1 dose escalation as of April 19, 2024:
| | | | | | | | | | | | | | | | | | | | |
Patients Treated | | Arm E (Lonca+Glofit) | | Arm F (Lonca+Mosun) | | Total |
| N=9 | | N=9 | | N=18 |
Patients with any SAE | | 1 (5.5%) | | 5 (5.5%) | | 6 (33.3%) |
Cytokine release syndrome* | | 1 (5.5%) | | 4 (44.4%) | | 5 (27.7%) |
Grade per ASTCT Criteria | | (grade 1) | | (grade 1 or 2) | | (grade 1 or 2) |
Sepsis | | 0 | | 1 (11.1%) | | 1 (5.5%) |
Dyspnea | | 0 | | 1 (11.1%) | | 1 (5.5%) |
Bronchiectasis | | 0 | | 1 (11.1%) | | 1 (5.5%) |
Bronchitis | | 0 | | 1 (11.1%) | | 1 (5.5%) |
Decompensation cardiac | | 0 | | 1 (11.1%) | | 1 (5.5%) |
Pneumonia pseudomonal | | 0 | | 1 (11.1%) | | 1 (5.5%) |
CRP increased | | 0 | | 1 (11.1%) | | 1 (5.5%) |
*CRS expressed as number of patients with at least 1 CRS event. 2 patients experienced multiple Grade 1 CRS events. 5 of 8 patients experiencing CRS coded SAE based on whether hospitalization required and/or prolonged.
MZL
Initial data from an investigator-initiated Phase 2 clinical trial evaluating ZYNLONTA® (loncastuximab tesirine-lpyl) for the treatment of relapsed/refractory (r/r) MZL were presented on May 4, 2024, at the Lymphoma Research Foundation’s 2024 Marginal Zone Lymphoma Scientific Workshop by the trial’s lead investigator, Izidore Lossos, MD, Professor, Director, Lymphoma Program at the Sylvester Comprehensive Cancer Center, University of Miami. The 50-patient single-arm, open-label Phase 2 multicenter study is currently being conducted at the Sylvester Comprehensive Cancer Center at University of Miami and City of Hope, and led by Izidore Lossos. This study is evaluating the safety and efficacy of 6 cycles of ZYNLONTA across 18 weeks in patients with r/r MZL previously treated with ≥1 line of systemic therapy (www.clinicaltrials.gov identifier NCT05296070). As of the data cutoff date of March 30, 2024, 15 patients were evaluable. Of these 15 patients evaluated, 13 achieved a complete response (“CR”) and one patient achieved a partial response (“PR”). All patients who achieved responses had maintained them at the time of the data cutoff with the longest responder reaching approximately 20 months.
In this study, according to the lead investigator, ZYNLONTA was generally well tolerated and safety was consistent with the known profile with two patient discontinuations. One patient discontinued after cycle 2 and a second patient discontinued after cycle 4 due to a toxicity which fully resolved upon discontinuation of treatment. Both of these patients remain in CR at 10 and 6 months respectively.
MZL is a rare, indolent non-Hodgkin lymphoma (“NHL”) and the third most common NHL subtype. In the United States, there are an estimated 3,000 - 4,000 r/r MZL patients treated with systemic anti-cancer regimens annually. There are few FDA-approved therapies for MZL. With existing treatment options, despite patients achieving durable responses, high unmet medical need remains with <30% CR for 2L+ NCCN preferred treatments. Achievement of complete response to treatment represents the strongest predictor of positive outcomes in MZL. As this investigator-initiated trial progresses, with the expected number of sites expanding to 5 to help accelerate trial enrollment, assuming the results continue to be positive, the Company plans to potentially pursue a regulatory pathway and compendia strategy in parallel as soon as sufficient data are available. We believe the total addressable 2L+ MZL patient population has a potential peak market value of approximately $500 million, which assumes a total addressable population and average net price for ZYNLONTA in 2030 with a CAGR ~2% and ~3% respectively, and average cycles expected in MZL. The potential expansion in MZL contributes to the overall ZYNLONTA growth strategy in NHL.
Solid Tumors
Research Strategy, Platform and Pipeline
Our solid tumor research strategy is focused on three key elements. First, we have identified areas of high unmet need that currently feature high use of chemotherapy. Second, we are pursuing targets within these tumor types that are amenable to an ADC approach. And third, we are utilizing our deep knowledge and broad toolkit to optimize the design of ADCs that fit with our first two criteria.
On April 9, 2024, the Company hosted a virtual Research Investor Event featuring presentations from Ameet Mallik, Chief Executive Officer, and Patrick van Berkel, PhD, Chief Scientific Officer, sharing details on this strategy and highlighting recent updates and the Company’s novel exatecan-based antibody drug conjugate platform.
As shared during this event, our four lead candidates have a differentiated profile based on a novel, proprietary linker approach to tracelessly release exatecan and a high therapeutic index, which reflects the proprietary design of our ADCs.
Our Napi2b and Claudin-6 targeting ADCs are in IND-enabling studies and our PSMA and ASCT2 targeting ADCs are in drug candidate selection stage which we expect to complete this year. The Company expects to select and sponsor one targeted drug candidate for advancement toward IND enabling activity.
Details include:
•Claudin-6 and NaPI2b: As recently presented at the American Association for Cancer Research (“AACR”) Annual Meeting from preclinical studies supporting the future clinical development two of our lead candidates GB01-VA-PL2202 targeting Claudin-6 and NaPi2b-PL2202 targeting NaPi2b. These preclinical studies demonstrated the Company’s novel, exatecan-based ADCs, targeting Claudin-6 and NaPi2b, were well tolerated with potent and specific in vitro and in vivo anti-tumor activity. Based on these results, we believe a Claudin-6 directed ADC and a NaPi2b directed ADC have the potential for high impact in platinum-resistant ovarian cancer and non-small cell lung cancer.
•PSMA: With PSMA-PL2202, we are developing an optimized ADC directed against a validated target with high potential impact in metastatic castrate resistant prostate cancer.
•ASCT2: And with ASCT2-PL2202, we are designing an optimized ADC directed against a novel target with high potential impact in many indications including - but not limited to - colorectal cancer and non-small cell lung cancer.
Beyond this, we are further diversifying our toolbox with drugs with other Mode of Actions, including other DNA damaging agents and immunomodulators and focus on conjugation technology to develop dual conjugate ADCs based on two different drugs with orthogonal modes of action.
2024 Equity Offering
In May 2024, the Company completed an underwritten offering of equity securities in which 13,411,912 of the Company’s common shares were sold to public investors at a price of $4.90 per share and pre-funded warrants (the “2024 Pre-Funded Warrants”) to purchase 8,163,265 of the Company’s common shares were sold to public investors at a price of $4.81 per pre-funded warrant, which equals the per share 2024 Equity Offering price, less the CHF 0.08 exercise price for each pre-funded warrant (collectively, the “2024 Equity Offering”). Gross proceeds from the 2024 Equity Offering were approximately $105.0 million, and, after giving effect to $7.6 million of transaction costs related to the offering, net proceeds were approximately $97.4 million.
The 2024 Pre-Funded Warrants are exercisable, on a cash basis (or, if there is no registration statement and current prospectus covering the issuance of the shares upon exercise, then on a cashless basis), at the option of the holder after the date of issuance until the tenth anniversary of their original issuance. At any time during the last 90 days of the term, the holder may exchange the Pre-Funded Warrant for, and we will issue, a new pre-funded warrant for the number of common shares then remaining under the Pre-Funded Warrant. The Pre-Funded Warrants have certain limitations on exercise, including (i) any exercise must be for at least 50,000 common shares (or, if less, the remaining common shares available for purchase under the Pre-Funded Warrants), (ii) a holder cannot exercise for any amount that would cause such holder’s beneficial ownership of our common shares to exceed 9.99% (or 19.99% with 61-days’ notice to us), and (iii) cashless exercise is not available in certain circumstances as specified in the Pre-Funded Warrants. The Pre-Funded Warrants contain customary anti-dilution adjustments and will entitle holders to receive any dividends or other distributions paid on the underlying common shares prior to their expiration on an as-exercised basis. For additional information, see our Current Report on Form 8-K filed with the SEC on May 8, 2024.
Results of Operations
Three Months Ended June 30, 2024 Compared to Three Months Ended June 30, 2023
The following table summarizes our results of operations for the three months ended June 30, 2024 and 2023:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, |
(in thousands, except percentages and per share) | 2024 | | 2023 | | Change | | % Change |
Revenue | | | | | | | |
Product revenues, net | $ | 17,030 | | | $ | 19,197 | | | $ | (2,167) | | | (11.3) | % |
License revenues and royalties | 380 | | | 86 | | | 294 | | | 341.9 | % |
Total revenue, net | 17,410 | | | 19,283 | | | (1,873) | | | (9.7) | % |
| | | | | | | |
Operating expense | | | | | | | |
Cost of product sales | (1,217) | | | (1,132) | | | (85) | | | 7.5 | % |
Research and development | (24,295) | | | (31,342) | | | 7,047 | | | (22.5) | % |
Selling and marketing | (10,701) | | | (14,456) | | | 3,755 | | | (26.0) | % |
General and administrative | (10,238) | | | (12,002) | | | 1,764 | | | (14.7) | % |
Total operating expense | (46,451) | | | (58,932) | | | 12,481 | | | (21.2) | % |
Loss from operations | (29,041) | | | (39,649) | | | 10,608 | | | (26.8) | % |
| | | | | | | |
Other income (expense) | | | | | | | |
Interest income | 3,253 | | | 2,372 | | | 881 | | | 37.1 | % |
Interest expense | (12,679) | | | (10,309) | | | (2,370) | | | 23.0 | % |
Other, net | 2,754 | | | (5,067) | | | 7,821 | | | (154.4) | % |
Total other expense, net | (6,672) | | | (13,004) | | | 6,332 | | | (48.7) | % |
| | | | | | | |
Loss before income taxes | (35,713) | | | (52,653) | | | 16,940 | | | (32.2) | % |
Income tax (expense) benefit | (234) | | | 4,498 | | | (4,732) | | | (105.2) | % |
Loss before equity in net losses of joint venture | (35,947) | | | (48,155) | | | 12,208 | | | (25.4) | % |
Equity in net losses of joint venture | (597) | | | (767) | | | 170 | | | (22.2) | % |
Net loss | $ | (36,544) | | | $ | (48,922) | | | $ | 12,378 | | | (25.3) | % |
| | | | | | | |
| | | | | | | |
Net loss per share, basic and diluted | $ | (0.38) | | | $ | (0.60) | | | $ | 0.22 | | | (36.7) | % |
Revenue
Product Revenues, net
We generate product revenue through the sale of ZYNLONTA in the United States. Revenue is recognized when control is transferred to the customer at the net selling price, which includes reductions for gross-to-net (“GTN”) sales adjustments such as government rebates, chargebacks, distributor service fees, other rebates and administrative fees, sales returns and allowances and sales discounts. In the long term, we expect that our product revenue will increase as we execute our business strategy, although our product revenue may fluctuate from period to period based on a number of factors, including patient demand, as well as the timing, dose and duration, of patient therapy and customers’ buying patterns and gross-to-net deductions. We may also experience variability in GTN sales adjustments as a percentage of gross sales due to additional information and actual experience such as actual rebate and return rates.
Product revenues, net, was $17.0 million for the three months ended June 30, 2024 as compared to $19.2 million for the three months ended June 30, 2023, a decrease of $2.2 million, or 11.3%. The decrease is primarily driven by lower sales volume, partially offset by a higher selling price.
License revenues and royalties
We generate license revenue and royalties from our strategic agreements for the development and commercialization of ZYNLONTA and other product candidates outside of the United States. Under these agreements, we receive upfront payments and are eligible for certain milestone payments and royalties. We are unable to predict the timing and amounts of
license revenue and royalties as meeting milestones is subject to many factors outside of our control and we have limited control over our partners’ commercialization efforts.
Royalties were $380 thousand for the three months ended June 30, 2024 as compared to $86 thousand for the three months ended June 30, 2023.
Operating Expenses
Cost of Product Sales
Cost of product sales primarily includes direct and indirect costs relating to the third-party manufacture and distribution of ZYNLONTA, royalties payable to a collaboration partner based on net product sales of ZYNLONTA and inventory write-downs. We expect that cost of product sales will increase on an absolute basis as product revenue increases and as we sell through pre-approval inventory that was previously expensed prior to commercialization under U.S. GAAP. Factors such as inflation may also increase our cost of product sales as a percentage of product revenue if we are not able to increase the price at which we sell ZYNLONTA to offset such increases in our cost of product sales.
Cost of product sales were $1.2 million for the three months ended June 30, 2024 as compared to cost of product sales of $1.1 million for the three months ended June 30, 2023 an increase of $0.1 million, or 7.5%. While product sales decreased, the increase in cost of product sales was primarily driven by higher commercial shipping and storage costs during the three months ended June 30, 2024 as compared to the three months ended June 30, 2023.
Research and Development Expenses
The following table summarizes our research and development expenses for our major development programs for the three months ended June 30, 2024 and 2023:
| | | | | | | | | | | | | | |
| Three Months Ended June 30, |
(in thousands) | 2024 | | 2023 | Change |
ZYNLONTA | $ | 12,150 | | | $ | 16,540 | | $ | (4,390) | |
Cami | 265 | | | 3,243 | | (2,978) | |
ADCT-601 | 4,520 | | | 2,548 | | 1,972 | |
ADCT-602 | 419 | | | 472 | | (53) | |
ADCT-901 | 692 | | | 2,272 | | (1,580) | |
ADCT-212 | — | | | 1,811 | | (1,811) | |
Preclinical product candidates and research pipeline | 3,706 | | | 2,538 | | 1,168 | |
Not allocated to specific programs(1) | 2,135 | | | 1,979 | | 156 | |
Share-based compensation expense (reversal) | 408 | | | (61) | | 469 | |
Research and development expenses | $ | 24,295 | | | $ | 31,342 | | $ | (7,047) | |
(1) Includes third-party contracting and employee expenses, as well as expense for preclinical research, storage, shipping and lab consumables that span multiple programs.
Research and development expense consists primarily of employee related expenses, including share-based compensation expense; costs for production of preclinical and clinical-stage product candidates by CMOs; fees and other costs paid to contract research organizations in connection with the performance of preclinical studies and clinical trials; costs of related facilities, materials and equipment; external costs associated with obtaining intellectual property; depreciation; and upfront fees and achieved milestone payments associated with R&D collaboration arrangements.
Our R&D expenses were $24.3 million for the three months ended June 30, 2024 as compared to $31.3 million for the three months ended June 30, 2023, a decrease of $7.0 million, or 22.5%, primarily due to lower spend on ZYNLONTA R&D as discussed in more detail below, a reduction of costs associated with Cami development as the program was discontinued, other productivity and cost savings initiatives and focused investment toward prioritized development programs.
ZYNLONTA
Research and development expenses for ZYNLONTA were $12.2 million for the three months ended June 30, 2024 as compared to $16.5 million for the three months ended June 30, 2023, a decrease of $4.4 million. The decrease was primarily due to lower clinical trial costs for LOTIS 3, LOTIS 5, LOTIS 6 and LOTIS 7, as well as lower professional fees
related to ZYNLONTA for the three months ended June 30, 2024 as a result of productivity initiatives and portfolio prioritization.
Cami
Research and development expenses for Cami were $0.3 million for the three months ended June 30, 2024 as compared to $3.2 million for the three months ended June 30, 2023, a decrease of $3.0 million. The decrease was primarily due to our evaluation of FDA feedback and decision to stop the program.
ADCT-601
Research and development expenses for ADCT-601 were $4.5 million for the three months ended June 30, 2024 as compared to $2.5 million for the three months ended June 30, 2023, an increase of $2.0 million. The increase is primarily attributable to higher patient enrollment and progress towards the completion of the study.
ADCT-901
Research and development expenses for ADCT-901 were $0.7 million for the three months ended June 30, 2024 as compared to $2.3 million for the three months ended June 30, 2023, a decrease of $1.6 million. The decrease is primarily attributable to lower clinical trial costs. We have re-prioritized the R&D pipeline to focus resources on the most advanced, lower risk value-generating programs and have therefore stopped investing on this preclinical program.
ADCT-212
Research and development expenses for ADCT-212 were nil for the three months ended June 30, 2024 as compared to $1.8 million for the three months ended June 30, 2023, a decrease of $1.8 million. The decrease is primarily attributable to a decrease in expenses related to IND enabling analytical work. We have re-prioritized the R&D pipeline to focus resources on the most advanced, lower risk value-generating programs and have therefore stopped investing on this preclinical program.
Preclinical product candidates and research pipeline
Research and development expenses associated with our preclinical product candidates and research pipeline were $3.7 million for the three months ended June 30, 2024 as compared to $2.5 million for the three months ended June 30, 2023, an increase of $1.2 million. The increase is primarily attributable to increased spending on our research strategy, platform and pipeline initiatives including Claudin-6, Napi2b, PSMA and ASCT2.
Share-based compensation
Share-based compensation expense was $0.4 million for the three months ended June 30, 2024 as compared to an expense reversal of $0.1 million for the three months ended June 30, 2023, an increase of $0.5 million. The increase was primarily driven by the expense reversal associated with forfeitures of awards recognized during the three months ended June 30, 2023 in connection with employee terminations and the workforce reduction announced and put into effect during the second quarter of 2023.
Selling and Marketing Expenses
The following table summarizes our selling and marketing expenses for the three months ended June 30, 2024 and 2023:
| | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, |
(in thousands) | 2024 | | 2023 | | Change |
External costs and overhead | $ | 4,850 | | | $ | 8,329 | | | $ | (3,479) | |
Employee expenses(1) | 5,654 | | | 6,746 | | | (1,092) | |
Share-based compensation (reversal) expense | 197 | | | (619) | | | 816 | |
Selling and marketing expenses | $ | 10,701 | | | $ | 14,456 | | | $ | (3,755) | |
(1)Excludes share-based compensation expense.
Selling and marketing costs (“S&M”) are expensed as incurred and are primarily attributable to commercialization of ZYNLONTA in the United States. S&M includes employee costs and share-based compensation expense for commercial employees and external costs related to commercialization (including professional fees, communication costs and IT costs, travel expenses and depreciation of property and equipment). We expect our S&M expenses to decrease as a percentage of revenue over time as we have transitioned to being a commercial-stage public organization and implemented a new go-to-market model in 2023 to help drive growth and optimize local area influence.
Selling and marketing expenses were $10.7 million for the three months ended June 30, 2024 as compared to $14.5 million for the three months ended June 30, 2023, a decrease of $3.8 million or 26.0%. The decrease in external costs and overhead was primarily attributable to $3.8 million in lower spend on marketing and advertising expenses as a result of reduced spending initiatives within the US, partially offset by $0.3 million in higher travel and IT expenses. The decrease in employee expenses was primarily due to lower wages and benefits of $0.8 million primarily due to decreased headcount, as well as lower recruitment costs of $0.3 million. The increase in share-based compensation expense of $0.8 million was primarily driven by the expense reversal associated with forfeitures of awards recognized during the three months ended June 30, 2023 in connection with employee terminations and the workforce reduction announced and put into effect during the second quarter of 2023.
General and Administrative Expenses
The following table summarizes our general and administrative expenses for the three months ended June 30, 2024 and 2023:
| | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, |
(in thousands) | 2024 | | 2023 | | Change |
External costs and overhead | $ | 3,897 | | | $ | 5,570 | | | $ | (1,673) | |
Employee expenses(1) | 4,958 | | | 4,634 | | | 324 | |
Share-based compensation expense | 1,383 | | | 1,798 | | | (415) | |
General and administrative expenses | $ | 10,238 | | | $ | 12,002 | | | $ | (1,764) | |
(1)Excludes share-based compensation expense.
General and administrative expense includes employee expenses (including share-based compensation expense) for general and administrative employees, external costs (including, in particular, professional fees, legal costs associated with maintaining patents and other intellectual property, communications costs and IT costs, facility expenses and travel expenses), depreciation of property and equipment, depreciation of right-of-use assets and amortization of intangible assets.
General and administrative expenses were $10.2 million for the three months ended June 30, 2024 as compared to $12.0 million for the three months ended June 30, 2023, a decrease of $1.8 million, or 14.7%. The decrease in external costs and overhead was primarily related to lower legal and audit fees of $1.2 million, insurance costs of $0.3 million and IT expenses of $0.2 million. The increase in employee expenses was primarily due to higher wages and benefits and recruitment costs. The decrease in share-based compensation expense was primarily due to fluctuations in our share price, as well as forfeitures of awards in connection with employee terminations.
Other Income (Expense)
Interest Income
Interest income includes interest received from banks on our cash balances. Our policy is to invest funds in a variety of capital preservation instruments, which may include all or a combination of cash and cash equivalents, short-term and long-term interest-bearing instruments, investment-grade securities, and direct or guaranteed obligations of the U.S. government.
Interest income was $3.3 million for the three months ended June 30, 2024 as compared to $2.4 million for the three months ended June 30, 2023, an increase of $0.9 million. The increase was due to higher average cash balances.
Interest Expense
Interest expense is primarily related to the accretion of our deferred royalty obligation with HCR and the senior secured term loan facility. Interest expense was $12.7 million for the three months ended June 30, 2024 as compared to $10.3 million for the three months ended June 30, 2023, an increase of $2.4 million, or 23.0%. The increase was related to higher accretion of our deferred royalty obligation with HCR as a result of the $73.1 million, net of transaction costs, received in
June 2023 upon the first commercial sale of ZYNLONTA in the United Kingdom or any European Union country, which increased the liability.
Other, net
Other, net consists primarily of changes in the fair value (gains or losses) of the Deerfield warrant obligation; and cumulative catch-up adjustments related to our deferred royalty obligation.
Other, net for the three months ended June 30, 2024 and 2023 included the following:
| | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, |
(in thousands) | 2024 | | 2023 | | Change |
| | | | | |
Deerfield warrant obligation, change in fair value income | 2,230 | | | $ | 20 | | | $ | 2,210 | |
Cumulative catch-up adjustment income (expense), deferred royalty obligation | 263 | | | (5,417) | | | 5,680 | |
Exchange differences (loss) gain | (59) | | | 15 | | | (74) | |
R&D tax credit | 320 | | | 315 | | | 5 | |
Total | $ | 2,754 | | | $ | (5,067) | | | $ | 7,821 | |
Deerfield Warrant Obligation, Change in Fair Value Income
Pursuant to an Exchange Agreement with Deerfield entered into on August 15, 2022, the Company issued warrants to Deerfield to purchase an aggregate of 4,412,840 common shares. The Deerfield warrant obligation has been recorded at its initial fair value at the time the agreement was entered into on August 15, 2022 and is remeasured to fair value at the end of each reporting period. The income of $2.2 million and nil as a result of changes in the warrant obligation for the three months ended June 30, 2024 and 2023, respectively, was primarily due to the decrease in fair value of the underlying shares during the respective periods.
Cumulative catch-up adjustment income (expense), deferred royalty obligation
We periodically assess the expected payments to HCR based on our underlying revenue projections and to the extent the amount or timing of such payments is materially different than our initial estimates we will record a cumulative catch-up adjustment to the deferred royalty obligation. The adjustment to the carrying amount is recognized in Other, net as an adjustment in the period in which the change in estimate occurred. The cumulative catch-up adjustment income (expense) was $0.3 million for the three months ended June 30, 2024 as compared to $(5.4) million for the three months ended June 30, 2023, a change of $5.7 million. The change was primarily due to revised revenue forecasts incorporated into the valuation model in 2023, which revisions were primarily attributable to the Company’s updated strategic and development plans.
Income Tax (Expense) Benefit
We are subject to corporate taxation in Switzerland. We are also subject to taxation in other jurisdictions in which we operate, in particular, the United States and the United Kingdom, where our two wholly-owned subsidiaries are incorporated. We recorded an income tax (expense) benefit of $(0.2) million for the three months ended June 30, 2024 as compared to $4.5 million for the three months ended June 30, 2023, primarily driven by our US operations and transfer pricing model which was implemented in the fourth quarter of 2023.
Equity in Net Losses of Joint Venture
| | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, |
(in thousands) | 2024 | | 2023 | | Change |
Share of Overland ADCT BioPharma net loss | $ | (597) | | | $ | (767) | | | $ | 170 | |
We recorded our proportionate share of Overland ADCT BioPharma’s net loss of $0.6 million and $0.8 million for the three months ended June 30, 2024 and 2023, respectively. The decrease in Overland ADCT BioPharma's net loss for the six months ended June 30, 2024 as compared to the six months ended June 30, 2023 was primarily attributable to lower R&D costs as the BLA submitted by Overland ADCT BioPharma has been accepted and granted priority review by the NMPA.
Six Months Ended June 30, 2024 Compared to Six Months Ended June 30, 2023
The following table summarizes our results of operations for the six months ended June 30, 2024 and 2023:
| | | | | | | | | | | | | | | | | | | | | | | |
| Six Months Ended June 30, |
(in thousands, except percentages and per share) | 2024 | | 2023 | | Change | | % Change |
Revenue | | | | | | | |
Product revenues, net | $ | 34,878 | | | $ | 38,150 | | | $ | (3,272) | | | (8.6) | % |
License revenues and royalties | 585 | | | 125 | | | 460 | | | 368.0 | % |
Total revenue, net | 35,463 | | | 38,275 | | | (2,812) | | | (7.3) | % |
| | | | | | | |
Operating expense | | | | | | | |
Cost of product sales | (3,727) | | | (1,105) | | | (2,622) | | | 237.3 | % |
Research and development | (50,030) | | | (69,717) | | | 19,687 | | | (28.2) | % |
Selling and marketing | (22,091) | | | (29,807) | | | 7,716 | | | (25.9) | % |
General and administrative | (22,269) | | | (27,505) | | | 5,236 | | | (19.0) | % |
Total operating expense | (98,117) | | | (128,134) | | | 30,017 | | | (23.4) | % |
Loss from operations | (62,654) | | | (89,859) | | | 27,205 | | | (30.3) | % |
| | | | | | | |
Other income (expense) | | | | | | | |
Interest income | 6,201 | | | 4,547 | | | 1,654 | | | 36.4 | % |
Interest expense | (25,175) | | | (20,600) | | | (4,575) | | | 22.2 | % |
Other, net | 159 | | | (4,234) | | | 4,393 | | | (103.8) | % |
Total other expense, net | (18,815) | | | (20,287) | | | 1,472 | | | (7.3) | % |
| | | | | | | |
Loss before income taxes | (81,469) | | | (110,146) | | | 28,677 | | | (26.0) | % |
Income tax (expense) benefit | (397) | | | 3,980 | | | (4,377) | | | (110.0) | % |
Loss before equity in net losses of joint venture | (81,866) | | | (106,166) | | | 24,300 | | | (22.9) | % |
Equity in net losses of joint venture | (1,284) | | | (2,130) | | | 846 | | | (39.7) | % |
Net loss | $ | (83,150) | | | $ | (108,296) | | | $ | 25,146 | | | (23.2) | % |
| | | | | | | |
| | | | | | | |
Net loss per share, basic and diluted | $ | (0.93) | | | $ | (1.33) | | | $ | 0.40 | | | (30.1) | % |
Revenue
Product Revenues, net
We generate product revenue through the sale of ZYNLONTA in the United States. Revenue is recognized when control is transferred to the customer at the net selling price, which includes reductions for gross-to-net (“GTN”) sales adjustments such as government rebates, chargebacks, distributor service fees, other rebates and administrative fees, sales returns and allowances and sales discounts. In the long term, we expect that our product revenue will increase as we execute our business strategy, although our product revenue may fluctuate from period to period based on a number of factors, including patient demand, as well as the timing, dose and duration, of patient therapy and customers’ buying patterns and gross-to-net deductions.
Product revenues, net, was $34.9 million for the six months ended June 30, 2024 as compared to $38.2 million for the six months ended June 30, 2023, a decrease of $3.3 million, or 8.6%. The decrease is primarily attributable to lower sales volume, partially offset by a higher price. The decrease in product revenues is also attributable to higher GTN deductions primarily due to a higher discarded drug rebate accrual for the six months ended June 30, 2024 compared to the six months ended June 30, 2023. We expect to continue experiencing these higher level of GTN sales adjustments as a percentage of gross sales, and may also experience variability in GTN sales adjustments due to additional information and actual experience such as actual rebate and return rates.
License revenues and royalties
We generate license revenue and royalties from our strategic agreements for the development and commercialization of ZYNLONTA and other product candidates outside of the United States. Under these agreements, we receive upfront payments and are eligible for certain milestone payments and royalties. We are unable to predict the timing and amounts of license revenue and royalties as meeting milestones is subject to many factors outside of our control and we have limited control over our partners’ commercialization efforts.
Royalties were $0.6 million for the six months ended June 30, 2024 as compared to $0.1 million for the six months ended June 30, 2023.
Operating Expenses
Cost of Product Sales
Cost of product sales primarily includes direct and indirect costs relating to the third-party manufacture and distribution of ZYNLONTA, royalties payable to a collaboration partner based on net product sales of ZYNLONTA and inventory write-downs. We expect that cost of product sales will increase on an absolute basis as product revenue increases and as we sell through pre-approval inventory that was previously expensed prior to commercialization under U.S. GAAP. Factors such as inflation may also increase our cost of product sales as a percentage of product revenue if we are not able to increase the price at which we sell ZYNLONTA to offset such increases in our cost of product sales.
Cost of product sales were $3.7 million for the six months ended June 30, 2024 as compared to cost of product sales of $1.1 million for the six months ended June 30, 2023. The increase is primarily attributable to a $1.1 million batch cancellation fee, a $0.6 million increase in our excess inventory reserve and higher stability, shipping and storage costs of $0.6 million recognized during the six months ended June 30, 2024, as well as a $0.3 million manufacturing credit received from a contract manufacturer which was recorded as a reduction to cost of product sales for the three months ended June 30, 2023.
Research and Development Expenses
The following table summarizes our research and development expenses for our major development programs for the six months ended June 30, 2024 and 2023:
| | | | | | | | | | | | | | |
| Six Months Ended June 30, |
(in thousands) | 2024 | | 2023 | Change |
ZYNLONTA | $ | 27,149 | | | $ | 35,768 | | $ | (8,619) | |
Cami | 930 | | | 8,989 | | (8,059) | |
ADCT-601 | 7,844 | | | 4,517 | | 3,327 | |
ADCT-602 | 723 | | | 807 | | (84) | |
ADCT-901 | 1,621 | | | 3,814 | | (2,193) | |
ADCT-212 | 86 | | | 4,099 | | (4,013) | |
Preclinical product candidates and research pipeline | 7,397 | | | 4,893 | | 2,504 | |
Not allocated to specific programs(1) | 4,422 | | | 3,789 | | 633 | |
Share-based compensation (reversal) expense | (142) | | | 3,041 | | (3,183) | |
Research and development expenses | $ | 50,030 | | | $ | 69,717 | | $ | (19,687) | |
(1) Includes third-party contracting and employee expenses, as well as expense for preclinical research, storage, shipping and lab consumables that span multiple programs.
Research and development expense consists primarily of employee related expenses, including share-based compensation expense; costs for production of preclinical and clinical-stage product candidates by CMOs; fees and other costs paid to contract research organizations in connection with the performance of preclinical studies and clinical trials; costs of related facilities, materials and equipment; external costs associated with obtaining intellectual property; depreciation; and upfront fees and achieved milestone payments associated with R&D collaboration arrangements.
Our R&D expenses were $50.0 million for the six months ended June 30, 2024 as compared to $69.7 million for the six months ended June 30, 2023, a decrease of $19.7 million, or 28.2%, primarily due to lower spending on ZYNLONTA and Cami programs, as discussed below and focused investment toward prioritized development programs.
ZYNLONTA
Research and development expenses for ZYNLONTA were $27.1 million for the six months ended June 30, 2024 as compared to $35.8 million for the six months ended June 30, 2023, a decrease of $8.6 million. The decrease was primarily due to lower clinical trial costs for LOTIS 3, LOTIS 5, LOTIS 6 and LOTIS 7, as well as lower professional fees related to ZYNLONTA for the six months ended June 30, 2024 as a result of productivity initiatives and portfolio prioritization.
Cami
Research and development expenses for Cami were $0.9 million for the six months ended June 30, 2024 as compared to $9.0 million for the six months ended June 30, 2023, a decrease of $8.1 million. The decrease was primarily due to our evaluation of FDA feedback and decision to stop the program.
ADCT-601
Research and development expenses for ADCT-601 were $7.8 million for the six months ended June 30, 2024 as compared to $4.5 million for the six months ended June 30, 2023, an increase of $3.3 million. The increase is primarily attributable to higher patient enrollment and progress towards the completion of the study.
ADCT-901
Research and development expenses for ADCT-901 were $1.6 million for the six months ended June 30, 2024 as compared to $3.8 million for the six months ended June 30, 2023, a decrease of $2.2 million. The decrease is primarily attributable to lower clinical trial costs. We have re-prioritized the R&D pipeline to focus resources on the most advanced, lower risk value-generating programs and have therefore stopped investing on this preclinical program.
ADCT-212
Research and development expenses for ADCT-212 were $0.1 million for the six months ended June 30, 2024 as compared to $4.1 million for the six months ended June 30, 2023, a decrease of $4.0 million. The decrease is primarily attributable to a decrease in expenses related to IND enabling analytical work. We have re-prioritized the R&D pipeline to focus resources on the most advanced, lower risk value-generating programs and have therefore stopped investing on this preclinical program.
Preclinical product candidates and research pipeline
Research and development expenses associated with our preclinical product candidates and research pipeline were $7.4 million for the six months ended June 30, 2024 as compared to $4.9 million for the six months ended June 30, 2023, an increase of $2.5 million. The increase is primarily attributable to increased spending on our research strategy, platform and pipeline initiatives including Claudin-6, Napi2b, PSMA and ASCT2.
Share-based compensation
Share-based compensation expense reversals were $0.1 million for the six months ended June 30, 2024 as compared to expense of $3.0 million for the six months ended June 30, 2023, a decrease of $3.2 million. The decrease was primarily driven by fluctuations in our share price as well as forfeitures of awards in connection with employee terminations.
Selling and Marketing Expenses
The following table summarizes our selling and marketing expenses for the six months ended June 30, 2024 and 2023:
| | | | | | | | | | | | | | | | | |
| Six Months Ended June 30, |
(in thousands) | 2024 | | 2023 | | Change |
External costs and overhead | $ | 10,662 | | | $ | 15,689 | | | $ | (5,027) | |
Employee expenses(1) | 11,872 | | | 14,030 | | | (2,158) | |
Share-based compensation (reversal) expense | (443) | | | 88 | | | (531) | |
Selling and marketing expenses | $ | 22,091 | | | $ | 29,807 | | | $ | (7,716) | |
(1)Excludes share-based compensation expense.
Selling and marketing costs (“S&M”) are expensed as incurred and are primarily attributable to commercialization of ZYNLONTA in the United States. S&M includes employee costs and share-based compensation expense for commercial employees and external costs related to commercialization (including professional fees, communication costs and IT costs, travel expenses and depreciation of property and equipment). We expect our S&M expenses to decrease as a percentage of revenue over time as we have transitioned to being a commercial-stage public organization and implemented a new go-to-market model in 2023 to help drive growth and optimize local area influence.
Selling and marketing expenses were $22.1 million for the six months ended June 30, 2024 as compared to $29.8 million for the six months ended June 30, 2023, a decrease of $7.7 million or 25.9%. The decrease in external costs and overhead was primarily attributable to $5.3 million in lower spend on marketing and advertising expenses as a result of reduced spending initiatives within the US, partially offset by higher travel and IT expenses of $0.3 million. The decrease in employee expenses was primarily due to lower wages and benefits of $1.9 million primarily due to decreased headcount, as well as lower recruitment costs of $0.2 million. The decrease in share-based compensation expense of $0.5 million was primarily due to fluctuations in our share price as well as forfeitures of awards in connection with employee terminations.
General and Administrative Expenses
The following table summarizes our general and administrative expenses for the six months ended June 30, 2024 and 2023:
| | | | | | | | | | | | | | | | | |
| Six Months Ended June 30, |
(in thousands) | 2024 | | 2023 | | Change |
External costs and overhead | $ | 9,774 | | | $ | 10,507 | | | $ | (733) | |
Employee expenses(1) | 9,764 | | | 10,935 | | | (1,171) | |
Share-based compensation expense | 2,731 | | | 6,063 | | | (3,332) | |
General and administrative expenses | $ | 22,269 | | | $ | 27,505 | | | $ | (5,236) | |
(1)Excludes share-based compensation expense.
General and administrative expense includes employee expenses (including share-based compensation expense) for general and administrative employees, external costs (including, in particular, professional fees, legal costs associated with maintaining patents and other intellectual property, communications costs and IT costs, facility expenses and travel expenses), depreciation of property and equipment, depreciation of right-of-use assets and amortization of intangible assets.
General and administrative expenses were $22.3 million for the six months ended June 30, 2024 as compared to $27.5 million for the six months ended June 30, 2023, a decrease of $5.2 million, or 19.0%. The decrease in external costs and overhead was primarily related to lower insurance and IT costs of $1.0 million, partially offset by higher legal and audit fees of $0.3 million. The decrease in employee expenses was primarily due to lower wages and benefits of $1.4 million partially offset by higher recruitment costs of $0.3 million. The decrease in share-based compensation expense was primarily due to fluctuations in our share price as well as forfeitures of awards in connection with employee terminations.
Other Income (Expense)
Interest Income
Interest income includes interest received from banks on our cash balances. Our policy is to invest funds in a variety of capital preservation instruments, which may include all or a combination of cash and cash equivalents, short-term and long-term interest-bearing instruments, investment-grade securities, and direct or guaranteed obligations of the U.S. government.
Interest income was $6.2 million for the six months ended June 30, 2024 as compared to $4.5 million for the six months ended June 30, 2023, an increase of $1.7 million or 36.4%. The increase was due to higher yields received on our cash deposits during the six months ended June 30, 2024 and higher average cash balances.
Interest Expense
Interest expense is primarily related to the accretion of our deferred royalty obligation with HCR and the senior secured term loan facility. Interest expense was $25.2 million for the six months ended June 30, 2024 as compared to $20.6 million for the six months ended June 30, 2023, an increase of $4.6 million, or 22.2%. The increase was related to higher accretion of our deferred royalty obligation with HCR as a result of the $73.1 million, net of transaction costs, received in June 2023 upon the first commercial sale of ZYNLONTA in the United Kingdom or any European Union country, which increased the liability.
Other, net
Other, net consists primarily of changes in the fair value (gains or losses) of the Deerfield warrant obligation; and cumulative catch-up adjustments related to our deferred royalty obligation.
Other, net for the six months ended June 30, 2024 and 2023 included the following:
| | | | | | | | | | | | | | | | | |
| Six Months Ended June 30, |
(in thousands) | 2024 | | 2023 | | Change |
| | | | | |
Deerfield warrant obligation, change in fair value (expense) income | (838) | | | $ | 636 | | | $ | (1,474) | |
Cumulative catch-up adjustment income (expense), deferred royalty obligation | 526 | | | (5,288) | | | 5,814 | |
Exchange differences loss | (96) | | | (37) | | | (59) | |
R&D tax credit | 567 | | | 455 | | | 112 | |
Total | $ | 159 | | | $ | (4,234) | | | $ | 4,393 | |
Deerfield Warrant Obligation, Change in Fair Value (Expense) Income
Pursuant to an Exchange Agreement with Deerfield entered into on August 15, 2022, the Company issued warrants to Deerfield to purchase an aggregate of 4,412,840 common shares. The Deerfield warrant obligation has been recorded at its initial fair value at the time the agreement was entered into on August 15, 2022 and is remeasured to fair value at the end of each reporting period. The (expense) income of $(0.8) million and $0.6 million as a result of changes in the warrant obligation for the six months ended June 30, 2024 and 2023, respectively, was primarily due to the (increase) decrease in fair value of the underlying shares during the respective periods.
Cumulative catch-up adjustment income (expense), deferred royalty obligation
We periodically assess the expected payments to HCR based on our underlying revenue projections and to the extent the amount or timing of such payments is materially different than our initial estimates we will record a cumulative catch-up adjustment to the deferred royalty obligation. The adjustment to the carrying amount is recognized in Other, net as an adjustment in the period in which the change in estimate occurred. The cumulative catch-up adjustment income (expense) was $0.5 million for the six months ended June 30, 2024 as compared to $(5.3) million for the six months ended June 30, 2023, a change of $5.7 million. The change was primarily due to revised revenue forecasts incorporated into the valuation model in 2023, which revisions were primarily attributable to the Company’s updated strategic and development plans.
Income Tax Expense (Benefit)
We are subject to corporate taxation in Switzerland. We are also subject to taxation in other jurisdictions in which we operate, in particular, the United States and the United Kingdom, where our two wholly-owned subsidiaries are incorporated. We recorded an income tax (expense) benefit of $(0.4) million for the six months ended June 30, 2024 as compared to $4.0 million for the six months ended June 30, 2023, primarily driven by our US operations and transfer pricing model which was implemented in the fourth quarter of 2023.
Equity in Net Losses of Joint Venture
| | | | | | | | | | | | | | | | | | | |
| Six Months Ended June 30, | | |
(in thousands) | 2024 | | 2023 | | Change | | |
Share of Overland ADCT BioPharma net loss | $ | (1,284) | | | $ | (2,130) | | | $ | 846 | | | |
We recorded our proportionate share of Overland ADCT BioPharma’s net loss of $1.3 million and $2.1 million for the six months ended June 30, 2024 and 2023, respectively. The decrease in Overland ADCT BioPharma's net loss for the six months ended June 30, 2024 as compared to the six months ended June 30, 2023 was primarily attributable to lower R&D costs as the BLA submitted by Overland ADCT BioPharma has been accepted and granted priority review by the NMPA.
Liquidity and Capital Resources
As of June 30, 2024, we had cash and cash equivalents of $300.1 million and believe that our current cash position and capital resources are sufficient to fund our operation and meet capital requirements for at least the next twelve months from the date of this report.
We had an accumulated deficit of $1,418.6 million as of June 30, 2024, and our operations have historically been funded primarily through equity offerings, debt financings and royalty financing arrangements.
We plan to continue to fund our operating needs through our existing cash and cash equivalents, revenues from sales of ZYNLONTA, potential milestone and royalty payments under our licensing agreements and additional equity financings, debt financings and/or other forms of financing, as well as funds provided by collaborations. We are continuously exploring strategic collaborations, business combinations, licensing opportunities or similar strategies for clinical development and commercialization of ZYNLONTA and/or our product candidates. However, we may be unable to obtain such financing, licensing and collaboration arrangements on favorable terms, if at all.
Sources of Liquidity and Capital Resources
To date, we have financed our operations primarily through equity financings, convertible debt and senior secured term loan financings, and additional funds provided by collaborations and royalty financings and sales of ZYNLONTA in the United States. For a description of the Loan Agreement, HCR Agreement and other license and collaboration agreements, see “Item 1. Business - Material Contracts” in our Annual Report.
In May 2024, the Company completed an underwritten offering which resulted in net proceeds of approximately $97.4 million. See “Recent Developments.”
Uses of Capital Resources
Our primary uses of capital are, and we expect will continue to be, research and development expenses, selling and marketing expenses, compensation and related expenses, interest and principal payments on debt obligations and other operating expenses. We expect to incur substantial expenses as we continue to devote substantial resources to research and development and marketing and commercialization efforts, in particular to grow ZYNLONTA in the 3L+ DLBCL setting, continue to study and advance ZYNLONTA in earlier lines of therapy and in combinations to potentially expand our market opportunity and further develop our pipeline and our ADC platform. Cash used to fund operating expenses is impacted by the timing of when we pay expenses, as reflected in the change in our outstanding accounts payable and accrued expenses, as well as the timing of collecting receivables from the sale of ZYNLONTA and paying royalties related to our deferred royalty obligation.
Cash Flows
The following table summarizes our cash flows for the six months ended June 30, 2024 and 2023:
| | | | | | | | | | | | | | | | | |
| Six Months Ended June 30, |
(in thousands) | 2024 | | 2023 | | Change |
Net cash (used in) provided by: | | | | | |
Operating activities | $ | (76,940) | | | $ | (50,380) | | | $ | (26,560) | |
Investing activities | (561) | | | (2,228) | | | 1,667 | |
Financing activities | 99,053 | | | 73,527 | | | 25,526 | |
Net change in cash and cash equivalents | $ | 21,552 | | | $ | 20,919 | | | $ | 633 | |
Net Cash Used in Operating Activities
Net cash used in operating activities was $76.9 million for the six months ended June 30, 2024 as compared to $50.4 million for the six months ended June 30, 2023, an increase of $26.6 million. The increase in cash used in operating
activities on a period over period basis was primarily due to the receipt of the $50.0 million in Sobi license milestone during the six months ended June 30, 2023 which was recognized in revenue in December 2022 upon approval of the Marketing Authorisation Application by the European Commission for ZYNLONTA in third-line DLBCL, partially offset by the lower net loss for the period of $25.1 million attributable to a decrease in operating expenses and the timing of cash payments and receipts.
Net Cash Used in Investing Activities
Net cash used in investing activities was $0.6 million for the six months ended June 30, 2024 as compared to $2.2 million for the six months ended June 30, 2023, a decrease of $1.7 million. The decrease in net cash used in investing activities relates to timing of purchases of property and equipment.
Net Cash Provided by Financing Activities
Net cash provided by financing activities was $99.1 million for the six months ended June 30, 2024 and primarily related to the net proceeds received from the completion of the Company’s 2024 Equity Offering in May 2024. Net cash provided by financing activities was $73.5 million for the six months ended June 30, 2023 and primarily related to the proceeds received under the deferred royalty obligation with HCR upon the first commercial sale of ZYNLONTA in the United Kingdom or any European Union country.
Off-Balance Sheet Arrangements
During the periods presented, we did not have, and we do not currently have, any off-balance sheet arrangements.
Contractual Obligations and Commitments
There have been no material changes from the contractual obligations and commitments previously disclosed in our Annual Report.
Critical Accounting Estimates
The preparation of our unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in our unaudited condensed consolidated financial statements. There have been no material changes to the significant accounting estimates previously disclosed in our Annual Report.
Recently Issued and Adopted Accounting Pronouncements
Refer to Note 2 to our unaudited condensed consolidated financial statements for recently adopted accounting pronouncements and recently issued accounting pronouncements not yet adopted as of the date of this Quarterly Report.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
We are not required to provide the information required by this Item 3 as we are a smaller reporting company.
Item 4. Controls and Procedures
Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has performed an evaluation of the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act) as of the end of the period covered by this report, as required by Rule 13a-15(b) under the Exchange Act. Based upon this evaluation, our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has concluded that, as of the end of the period covered by this Quarterly Report, our disclosure controls and procedures were effective in ensuring that the information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified by the SEC’s rules and forms, and that the information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Changes in Internal Control Over Financial Reporting
There were no changes to internal control over financial reporting during the period covered by this report that would have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II: OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, we may be subject to various legal proceedings and claims that arise in the ordinary course of our business activities. The results of litigation and claims cannot be predicted with certainty. As of the date of this Quarterly Report, we do not believe that we are party to any claim or litigation, the outcome of which would, individually or in the aggregate, be reasonably expected to have a material adverse effect on our business.
Item 1A. Risk Factors
Below we are providing, in supplemental form, additions to our risk factors as previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023.
We do not control the conduct of current or any potential future investigator-initiated clinical trials, and the data from such trials is not subject to our review or quality control.
We have provided clinical data from an investigator-initiated Phase 2 clinical trial of ZYNLONTA for the treatment of relapsed/refractory marginal zone lymphoma. In the future, we may provide clinical data from this and other investigator-initiated clinical trials. We do not control the design or administration of such trials, nor the submission, approval or maintenance of any regulatory and institutional filings required to conduct such trials. Furthermore, we have limited or no rights to audit, review or apply quality control procedures to the clinical data generated from such trials. As a result, we have no control over the conduct of such trials and the timing of any data releases from such trials and we cannot be certain that such trials are or will be conducted in accordance with applicable regulatory requirements or that the clinical data provided to us by the investigators of such trials are accurate, reliable or complete. There can be no assurance regarding the outcome or timing of any IITs, including whether such trials will meet their respective endpoint and whether severe adverse events will occur during the trials. In addition, positive preliminary results in any ongoing IIT may not be predictive of results in the completed trial.
Our articles of association provide that the competent court with jurisdiction over our registered office in Switzerland will be the exclusive forum for shareholder suits against us, members of our board of directors or members of our executive committee.
Our articles of association provide that the competent court with jurisdiction over our registered office in Switzerland will be the exclusive forum for shareholder suits against us, members of our board of directors or members of our executive committee; provided that the foregoing provision does not apply to claims brought to enforce a duty or liability created by the Securities Act or the Exchange Act or any claim for which the courts in the United States have exclusive jurisdiction. This forum selection provision may impose additional litigation costs on shareholders in pursuing any such claims, particularly if the shareholders do not reside in or near Switzerland and limit a shareholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us, members of our board of directors or members of our executive committee, which may discourage lawsuits against us, members of our board of directors and members of our executive committee, although our shareholders will not be deemed to have waived our compliance with federal securities laws and the rules and regulations thereunder.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Recent Sales of Unregistered Securities
There were no sales of unregistered equity securities during the period covered by this report.
Issuer Purchases of Equity Securities
There were no purchases of our equity securities by or on behalf of us or any affiliated purchaser during the period covered by this report.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosure
Not applicable.
Item 5. Other Information
Insider Trading Arrangements
None of our directors or officers adopted or terminated a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement during the period covered by this report.
Item 6. Exhibits
Exhibits
The exhibits listed below are filed with or incorporated by reference into this Quarterly Report.
| | | | | | | | | | | | | | | | | | | | |
| | | Incorporation by Reference |
Exhibit No. | Description | | Form | File No. | Exhibit No. | Filing Date |
3.1 | | | 6-K | 001-39071 | 99.1 | June 14, 2023 |
4.1 | | | 8-K | 001-39071 | 4.1 | May 8, 2024 |
10.1* | | | | | | |
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) | | | | | |
* Filed herewith.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| | | | | | | | | | | |
| | ADC Therapeutics SA |
| | | /s/ Ameet Mallik |
Date: August 6, 2024 | | By: | Ameet Mallik |
| | | Chief Executive Officer |
| | | (Principal Executive Officer) |
| | | |
| | | | | | | | | | | |
| | | /s/ Jose Carmona |
Date: August 6, 2024 | | By: | Jose Carmona |
| | | Chief Financial Officer |
| | | (Principal Financial Officer) |
| | | |
| | | | | | | | | | | |
| | | /s/ Lisa Kallebo |
Date: August 6, 2024 | | By: | Lisa Kallebo |
| | | Corporate Controller and Chief Accounting Officer |
| | | (Principal Accounting Officer) |
| | | |
EXHIBIT 10.1 Execution Version US-DOCS151619295.4 SECOND LIMITED WAIVER TO LOAN AGREEMENT AND GUARANTY THIS SECOND LIMITED WAIVER TO LOAN AGREEMENT AND GUARANTY (this “Waiver”) is entered into effective as of June 24, 2024 (the “Effective Date”) among ADC THERAPEUTICS SA, a company formed under the laws of Switzerland (the “Borrower”), each of the Borrower’s Subsidiaries party hereto, the Lenders party hereto and BLUE OWL OPPORTUNISTIC MASTER FUND I, L.P. (formerly known as Owl Rock Opportunistic Master Fund I, L.P.), a New York limited partnership, in its capacity as administrative agent and collateral agent for itself and the Lenders (in such capacity, the “Agent”). WITNESSETH: WHEREAS, the Borrower, each of the Borrower’s Subsidiaries party thereto from time to time, the Agent and the Lenders party thereto from time to time are parties to that certain Loan Agreement and Guaranty, dated as of August 15, 2022 (as amended, restated, amended and restated, supplemented or otherwise modified from time to time prior to the date hereof, the “Loan Agreement”; unless otherwise defined herein, all capitalized terms used herein that are defined in the Loan Agreement shall have the meanings given such terms in the Loan Agreement); WHEREAS, the Agent and the Lenders allege as follows: certain Defaults and/or Events of Default have occurred and are continuing under the Loan Agreement as a result of a breach the requirements of (i) the definition of “Excluded Subsidiary” of the Loan Agreement with respect to the Borrower’s failure to notify Agent with respect to the dissolution of ADC NL, (ii) Section 7.13(b) of the Loan Agreement with respect to the Borrower’s failure to join ADC NL to the applicable Loan Documents and provide such other documents required therefor within the time period specified therefor in such Section, (iii) Section 7.15 of the Loan Agreement with respect to the Borrower’s failure to notify the Agent promptly of the Defaults described in forgoing clauses (i) and (ii) and (iv) any Events of Default solely arising from the existence of the Defaults and/or Events of Default described in the foregoing (clauses (i), (ii), (iii) and (iv) collectively, the “Specified Defaults”); WHEREAS, the Loan Parties have requested that the Agent and the Lenders agree to waive the Specified Defaults; NOW THEREFORE, in consideration of the premises contained herein, and for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto, intending to be legally bound, hereby agree as follows: SECTION 1. Limited Waiver. Subject to the satisfaction or waiver in writing of each of the conditions set forth in Section 2 below and in reliance upon the representations, warranties, covenants and agreements of the Loan Parties contained in this Waiver, the Agent and the Lenders party hereto hereby agree to (x) waive the Specified Defaults and (y) waive the accrual of interest at the Default Rate as a result of the Specified Defaults. Nothing contained in this Section 1 or otherwise in this Waiver is, or shall be deemed to be: (i) a consent to, or waiver of, any other action or inaction of the Borrower or any other Loan Party that constitutes (or would constitute) a violation of or a departure from any provision of the Loan Agreement or any other Loan Document, or which constitutes (or would constitute) a Default or Event of Default (other than the Specified
2 US-DOCS151619295.4 Defaults), (ii) except as set forth in this Section 1, constitute a waiver of any right or remedy of the Agent or any Lender under the Loan Agreement or any other Loan Document (all such rights and remedies being expressly reserved by the Agent and the Lenders); or (iii) establish a custom or course of dealing or conduct between the Agent or any Lender, on the one hand, and the Loan Parties on the other hand. SECTION 2. Conditions Precedent. The effectiveness of this Waiver is subject to satisfaction of each of the following conditions precedent: 2.1 Executed Waiver. Agent shall have received counterparts of this Waiver duly executed by the Borrower, the other Loan Parties and each of the Lenders. 2.2 Absence of Defaults. No Default or Event of Default, other than the Specified Defaults, shall have occurred and be continuing immediately prior to giving effect to this Waiver, and no Default or Event of Default shall have occurred and be continuing immediately after giving effect to this Waiver. 2.3 Representations and Warranties. The representations and warranties set forth in Section 2 of this Waiver shall be true and correct; and 2.4 Fees and Expenses. The Borrower shall have paid all reasonable and documented out-of-pocket fees, costs and expenses due and payable to the Agent and each Lender and reimbursement of Agent’s and each Lender’s current expenses reimbursable pursuant to Section 11.12 of the Loan Agreement, including all reasonable and documented out-of-pocket expenses of the Agent and the Lenders incurred in connection with this Waiver (including the Agent’s and the Lenders’ legal fees and expenses reimbursable pursuant to Section 11.12 of the Loan Agreement). SECTION 3. Representations and Warranties. In order to induce the Agent and the Lenders to enter into this Waiver, each of the Borrower and the other Loan Parties hereby represent and warrants to the Agent and the Lenders that: 3.1 Accuracy of Representations and Warranties. Each of the representations and warranties of the Loan Parties set forth in Section 5 of the Loan Agreement (except that the date “December 31, 2021” in Section 5.4 shall be deemed to be “December 31, 2023”) and in the other Loan Documents are true and correct in all material respects (or, if such representation or warranty is already qualified as to materiality or Material Adverse Effect, in all respects) with the same effect as though made on and as of the date hereof, except to the extent such representations and warranties expressly relate to an earlier date; provided that the applicable representation and warranties set forth in Section 5 of the Loan Agreement shall be qualified so as to exclude each of the relevant matters disclosed to the Agent and Lenders party hereto prior to the Effective Date. 3.2 No Conflicts. Each Loan Party’s execution, delivery and performance of this Waiver (i) have been duly authorized by all necessary corporate action of such Loan Party, (ii) will not result in the creation or imposition of any Lien upon the Collateral, other than Permitted Liens and the Liens created by the Loan Agreement and the other Loan Documents, (iii) do not violate any provisions of such Loan Party’s constitutional documents, trust deeds, or other Organizational Documents (as applicable), bylaws or other equivalent governing document, or any law,
3 US-DOCS151619295.4 regulation, order, injunction, judgment, decree or writ to which such Loan Party is subject, and (iv) do not violate any material contract or agreement, including any Material Agreements, or require any material consent or approval of any other Person which has not already been obtained. The individual or individuals executing this Waiver are duly authorized to do so. 3.3 Enforceability. This Waiver constitute a legal, valid and binding obligation of each Loan Party party hereto, enforceable against each such Loan Party in accordance with its terms, except as the enforcement hereof may be limited by insolvency, bankruptcy, reorganization, moratorium or other similar applicable laws affecting creditors rights generally or by general equitable principles (whether considered in a proceeding in equity or at law). SECTION 4. Miscellaneous. 4.1 Confirmation and Effect. The provisions of the Loan Agreement shall remain in full force and effect in accordance with its terms following the effectiveness of this Waiver, and, except as expressly set forth herein, this Waiver shall not constitute a waiver of any provision of the Loan Agreement or any other Loan Document. 4.2 Parties in Interest. All of the terms and provisions of this Waiver shall bind and inure to the benefit of the parties hereto and their respective successors and assigns. 4.3 Counterparts; Electronic Execution. This Waiver may be executed in any number of counterparts, and by different parties hereto in separate counterparts, each of which when so delivered shall be deemed an original, but all of which counterparts shall constitute but one and the same instrument. Delivery of an executed counterpart of a signature page of this Waiver by facsimile, portable document format (.pdf) or other electronic transmission will be as effective as delivery of a manually executed counterpart hereof. The words “execution,” “execute”, “signed,” “signature,” and words of like import in or related to any document to be signed in connection with this Waiver and the transactions contemplated hereby (including without limitation assignments, assumptions, amendments, waivers and consents) shall be deemed to include electronic signatures, the electronic matching of assignment terms and contract formations on electronic platforms approved by Agent, or the keeping of records in electronic form, each of which shall be of the same legal effect, validity or enforceability as a manually executed signature or the use of a paper-based recordkeeping system, as the case may be, to the extent and as provided for in any applicable law, including the Federal Electronic Signatures in Global and National Commerce Act, the New York State Electronic Signatures and Records Act, or any other similar state laws based on the Uniform Electronic Transactions Act and/or any other similar, applicable laws of the jurisdiction of formation, organization or incorporation, as applicable, of any Loan Party. 4.4 Entire Agreement. This Waiver and the other Loan Documents constitute the entire agreement and understanding of the parties hereto in respect of the subject matter hereof and thereof, and supersede and replace in their entirety any prior proposals, term sheets, non-disclosure or confidentiality agreements, letters, negotiations or other documents or agreements, whether written or oral, with respect to the subject matter hereof or thereof. EACH LOAN PARTY ACKNOWLEDGES, REPRESENTS AND WARRANTS THAT IN DECIDING TO ENTER INTO THIS WAIVER AND THE OTHER LOAN DOCUMENTS OR IN TAKING OR NOT
4 US-DOCS151619295.4 TAKING ANY ACTION HEREUNDER OR THEREUNDER, IT HAS NOT RELIED, AND WILL NOT RELY, ON ANY STATEMENT, REPRESENTATION, WARRANTY, COVENANT, AGREEMENT OR UNDERSTANDING, WHETHER WRITTEN OR ORAL, OF OR WITH AGENT OR THE LENDERS OTHER THAN THOSE EXPRESSLY SET FORTH IN THIS WAIVER AND THE OTHER LOAN DOCUMENTS. 4.5 Severability. Whenever possible, each provision of this Waiver shall be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Waiver shall be prohibited by or invalid under such law, such provision shall be ineffective only to the extent and duration of such prohibition or invalidity, without invalidating the remainder of such provision or the remaining provisions of this Waiver. 4.6 Loan Document. The parties hereto acknowledge and agree that this Waiver is a Loan Document. 4.7 Governing Law; Consent to Jurisdiction and Venue; Mutual Waiver of Jury Trial. THIS WAIVER AND THE RIGHTS AND OBLIGATIONS OF THE PARTIES HEREUNDER SHALL BE GOVERNED BY, AND CONSTRUED AND ENFORCED IN ACCORDANCE WITH, THE LAW OF THE STATE OF NEW YORK, EXCLUDING CONFLICT OF LAWS PRINCIPLES THAT WOULD CAUSE THE APPLICATION OF LAWS OF ANY OTHER JURISDICTION. Sections 11.10 and 11.11 of the Loan Agreement are hereby incorporated by reference as if fully set forth in this Waiver mutatis mutandis. 4.8 Confidential Information. Agent and the Lenders party hereto acknowledge that this Waiver shall constitute “Confidential Information” for the purposes of the Loan Agreement. [Signature Pages Follow]
[Signature Page to Second Limited Waiver to Loan Agreement and Guaranty] IN WITNESS WHEREOF, the parties hereto have caused this Waiver to be duly executed by their respective authorized officers on the date and year first above written. Name:Title: GUARANTORS:ADC THERAPEUTICS (UK) LIMITEDBy: /s/ Patrick Van BerkelName: Patrick Van Berkel Title: Director ADC THERAPEUTICS AMERICA, INC.By: /s/Ameet MallikName: Ameet Mallik Title: President and Chairman of the Board BORROWER:ADC THERAPEUTICS SA By: /s/ Ameet Mallik Ameet Mallik Chief Executive Officer
[Signature Page to Second Limited Waiver to Loan Agreement and Guaranty] AGENT: BLUE OWL OPPORTUNISTIC MASTER FUND I, L.P. By: Blue Owl Opportunistic GP, LLC its General Partner By: /s/ Meenal Mehta Name: Meenal Mehta Title: Authorized Signatory
[Signature Page to Second Limited Waiver to Loan Agreement and Guaranty] LENDERS: OR OPPORTUNISTIC DL (C), L.P. By: OR Opportunistic DL (C) GP, LLC its General Partner By: Owl Rock Capital Group LLC its Sole Member By: /s/ Meenal Mehta Name: Meenal Mehta Title: Authorized Signatory BLUE OWL OPPORTUNISTIC MASTER FUND I, L.P. By: Blue Owl Opportunistic GP, LLC its General Partner By: /s/ Meenal Mehta Name: Meenal Mehta Title: Authorized Signatory
[Signature Page to Second Limited Waiver to Loan Agreement and Guaranty] OAKTREE SPECIALTY LENDING CORPORATION By: Oaktree Fund Advisors, LLC Its: Investment Advisor By: /s/ Matthew Stewart Name: Matthew Stewart Title: Managing Director By: /s/ Mary Gallegly Name: Mary Gallegly Title: Managing Director
[Signature Page to Second Limited Waiver to Loan Agreement and Guaranty] OAKTREE AZ STRATEGIC LENDING FUND, L.P. By: Oaktree AZ Strategic Lending Fund GP, L.P. Its: General Partner By: Oaktree Fund GP IIA, LLC Its: General Partner By: Oaktree Fund GP II, L.P. Its: Managing Member By: /s/ Matthew Stewart Name: Matthew Stewart Title: Authorized Signatory By: /s/ Mary Gallegly Name: Mary Gallegly Title: Authorized Signatory
[Signature Page to Second Limited Waiver to Loan Agreement and Guaranty] OAKTREE STRATEGIC CREDIT FUND By: Oaktree Fund Advisors, LLC Its: Investment Advisor By: /s/ Matthew Stewart Name: Matthew Stewart Title: Managing Director By: /s/ Mary Gallegly Name: Mary Gallegly Title: Managing Director
[Signature Page to Second Limited Waiver to Loan Agreement and Guaranty] OAKTREE DIVERSIFIED INCOME FUND, INC. By: Oaktree Fund Advisors, LLC Its: Investment Advisor By: /s/ Matthew Stewart Name: Matthew Stewart Title: Managing Director By: /s/ Mary Gallegly Name: Mary Gallegly Title: Managing Director
[Signature Page to Second Limited Waiver to Loan Agreement and Guaranty] OAKTREE LSL HOLDINGS EURRC S.À R.L., a private limited liability company (société à responsabilité limitée) governed by the laws of the Grand Duchy of Luxembourg, having its registered office at 26A, boulevard Royal, L-2449 Luxembourg, Grand Duchy of Luxembourg and registered with the Luxembourg Trade and Companies Register (Registre de Commerce et des Sociétés, Luxembourg) under number B263341. Flora VERRECCHIA By: /s/ Martin Eckel /s/ Flora Verrecchia Name: Martin Eckel Title:Manager Manager
[Signature Page to Second Limited Waiver to Loan Agreement and Guaranty] OAKTREE LSL FUND HOLDINGS EURRC S.à r.l. 26A, boulevard Royal L-2449 Luxembourg R.C.S Number: B269245 By: /s/ Martin Eckel Name: Martin Eckel Title: Manager By: /s/ Flora Verrecchia Name: Flora VERRECCHIA Title: Manager
Exhibit 31.1
CERTIFICATION UNDER SECTION 302
I, Ameet Mallik, certify that:
1.I have reviewed this Quarterly Report on Form 10-Q of ADC Therapeutics SA;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report;
4.The company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the company and have:
a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b.Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c.Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d.Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the company’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting; and
5. The company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the company’s auditors and the audit committee of the company’s board of directors (or persons performing the equivalent functions):
a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the company’s ability to record, process, summarize and report financial information; and
b.Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting.
| | | | | | | | |
Date: | August 6, 2024 | /s/ Ameet Mallik Ameet Mallik Chief Executive Officer |
Exhibit 31.2
CERTIFICATION UNDER SECTION 302
I, Jose Carmona, certify that:
1.I have reviewed this Quarterly Report on Form 10-Q of ADC Therapeutics SA;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report;
4.The company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the company and have:
a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b.Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c.Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d.Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the company’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting; and
5. The company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the company’s auditors and the audit committee of the company’s board of directors (or persons performing the equivalent functions):
a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the company’s ability to record, process, summarize and report financial information; and
b.Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting.
| | | | | | | | |
Date: | August 6, 2024 | /s/ Jose Carmona Jose Carmona Chief Financial Officer |
Exhibit 32.1
CERTIFICATION UNDER SECTION 906
The certification set forth below is being submitted in connection with ADC Therapeutics SA’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 (the “Report”) for the purpose of complying with Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code.
I, Ameet Mallik, the Chief Executive Officer of ADC Therapeutics SA, certify that:
1.the Report fully complies with the requirements of Section 13(a) or 15(d) of the Exchange Act; and
2.the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of ADC Therapeutics SA.
| | | | | | | | |
Date: | August 6, 2024 | /s/ Ameet Mallik Ameet Mallik Chief Executive Officer |
Exhibit 32.2
CERTIFICATION UNDER SECTION 906
The certification set forth below is being submitted in connection with ADC Therapeutics SA’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 (the “Report”) for the purpose of complying with Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code.
I, Jose Carmona, the Chief Financial Officer of ADC Therapeutics SA, certify that:
1.the Report fully complies with the requirements of Section 13(a) or 15(d) of the Exchange Act; and
2.the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of ADC Therapeutics SA.
| | | | | | | | |
Date: | August 6, 2024 | /s/ Jose Carmona Jose Carmona Chief Financial Officer |
v3.24.2.u1
Cover - shares
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6 Months Ended |
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Jun. 30, 2024 |
Aug. 01, 2024 |
Cover [Abstract] |
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ADC Therapeutics SA
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Entity Incorporation, State or Country Code |
V8
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Entity Address, Address Line One |
Biopôle
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Entity Address, Address Line Two |
Route de la Corniche 3B
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Entity Address, Country |
CH
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41
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21 653
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Title of 12(g) Security |
Common Shares, par value CHF 0.08 per share
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ADCT
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v3.24.2.u1
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Current assets |
|
|
Cash and cash equivalents |
$ 300,119
|
$ 278,598
|
Accounts receivable, net |
22,868
|
25,182
|
Inventory |
15,191
|
16,177
|
Prepaid expenses and other current assets |
17,181
|
16,334
|
Total current assets |
355,359
|
336,291
|
Property and equipment, net |
5,483
|
5,622
|
Operating lease right-of-use assets |
9,685
|
10,511
|
Interest in joint venture |
260
|
1,647
|
Other long-term assets |
992
|
711
|
Total assets |
371,779
|
354,782
|
Current liabilities |
|
|
Accounts payable |
10,708
|
15,569
|
Accrued expenses and other current liabilities |
46,924
|
52,101
|
Total current liabilities |
57,632
|
67,670
|
Deferred royalty obligation, long-term |
316,211
|
303,572
|
Senior secured term loans |
113,673
|
112,730
|
Operating lease liabilities, long-term |
9,309
|
10,180
|
Other long-term liabilities |
6,624
|
8,879
|
Total liabilities |
503,449
|
503,031
|
Commitments and contingencies (See Note 13) |
|
|
Shareholders’ equity (deficit) |
|
|
Common shares, at CHF $0.08 par value Issued shares: 99,453,858 at June 30, 2024 and 89,041,946 December 31, 2023; outstanding shares: 96,469,641 at June 30, 2024 and 82,293,137 at December 31, 2023 |
8,233
|
7,312
|
Additional paid-in capital |
1,279,296
|
1,180,545
|
Treasury shares At June 30, 2024: 2,984,217 and December 31, 2023: 6,748,809 |
(239)
|
(541)
|
Accumulated other comprehensive loss |
(338)
|
(93)
|
Accumulated deficit |
(1,418,622)
|
(1,335,472)
|
Total shareholders’ equity (deficit) |
(131,670)
|
(148,249)
|
Total liabilities and shareholders’ equity (deficit) |
$ 371,779
|
$ 354,782
|
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CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - SFr / shares
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Statement of Financial Position [Abstract] |
|
|
Common shares, par value (in CHF per share) |
SFr 0.08
|
SFr 0.08
|
Common shares issued (in shares) |
99,453,858
|
89,041,946
|
Common shares outstanding (in shares) |
96,469,641
|
82,293,137
|
Treasury shares (in shares) |
2,984,217
|
6,748,809
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.24.2.u1
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Revenue |
|
|
|
|
Product revenues, net |
$ 17,030
|
$ 19,197
|
$ 34,878
|
$ 38,150
|
License revenues and royalties |
380
|
86
|
585
|
125
|
Total revenue, net |
17,410
|
19,283
|
35,463
|
38,275
|
Operating expense |
|
|
|
|
Cost of product sales |
(1,217)
|
(1,132)
|
(3,727)
|
(1,105)
|
Research and development |
(24,295)
|
(31,342)
|
(50,030)
|
(69,717)
|
Selling and marketing |
(10,701)
|
(14,456)
|
(22,091)
|
(29,807)
|
General and administrative |
(10,238)
|
(12,002)
|
(22,269)
|
(27,505)
|
Total operating expense |
(46,451)
|
(58,932)
|
(98,117)
|
(128,134)
|
Loss from operations |
(29,041)
|
(39,649)
|
(62,654)
|
(89,859)
|
Other income (expense) |
|
|
|
|
Interest income |
3,253
|
2,372
|
6,201
|
4,547
|
Interest expense |
(12,679)
|
(10,309)
|
(25,175)
|
(20,600)
|
Other, net |
2,754
|
(5,067)
|
159
|
(4,234)
|
Total other expense, net |
(6,672)
|
(13,004)
|
(18,815)
|
(20,287)
|
Loss before income taxes |
(35,713)
|
(52,653)
|
(81,469)
|
(110,146)
|
Income tax (expense) benefit |
(234)
|
4,498
|
(397)
|
3,980
|
Loss before equity in net losses of joint venture |
(35,947)
|
(48,155)
|
(81,866)
|
(106,166)
|
Equity in net losses of joint venture |
(597)
|
(767)
|
(1,284)
|
(2,130)
|
Net loss |
$ (36,544)
|
$ (48,922)
|
$ (83,150)
|
$ (108,296)
|
Net loss per share |
|
|
|
|
Net loss per share, basic (in dollars per share) |
$ (0.38)
|
$ (0.60)
|
$ (0.93)
|
$ (1.33)
|
Net loss per share, diluted (in dollars per share) |
$ (0.38)
|
$ (0.60)
|
$ (0.93)
|
$ (1.33)
|
Weighted average shares outstanding, basic (in shares) |
95,691,245
|
81,471,127
|
89,121,783
|
81,140,287
|
Weighted average shares outstanding, diluted (in shares) |
95,691,245
|
81,471,127
|
89,121,783
|
81,140,287
|
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v3.24.2.u1
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Statement of Comprehensive Income [Abstract] |
|
|
|
|
Net loss |
$ (36,544)
|
$ (48,922)
|
$ (83,150)
|
$ (108,296)
|
Other comprehensive (loss) income: |
|
|
|
|
Remeasurement of defined benefit plan |
(81)
|
(40)
|
(81)
|
(79)
|
Currency translation differences |
17
|
170
|
(61)
|
311
|
Other comprehensive (loss) income before share of other comprehensive loss in joint venture |
(64)
|
130
|
(142)
|
232
|
Share of other comprehensive loss in joint venture |
(73)
|
(444)
|
(103)
|
(700)
|
Other comprehensive loss |
(137)
|
(314)
|
(245)
|
(468)
|
Total comprehensive loss |
$ (36,681)
|
$ (49,236)
|
$ (83,395)
|
$ (108,764)
|
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- DefinitionOther Comprehensive Income (Loss) Before OCI, Equity Method Investment, Net Of Tax, Portion Attributable to Parent
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v3.24.2.u1
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY (DEFICIT) - USD ($) $ in Thousands |
Total |
Common stock |
Additional paid-in capital |
Treasury stock |
Accumulated other comprehensive (loss) income |
Accumulated deficit |
Beginning balance (in shares) at Dec. 31, 2022 |
|
89,041,946
|
|
|
|
|
Beginning balance at Dec. 31, 2022 |
$ 79,451
|
$ 7,312
|
$ 1,166,414
|
$ (679)
|
$ 1,823
|
$ (1,095,419)
|
Treasury stock, beginning balance (in shares) at Dec. 31, 2022 |
|
|
|
(8,399,419)
|
|
|
Increase (Decrease) in Stockholders' Equity [Roll Forward] |
|
|
|
|
|
|
Loss for the period |
(108,296)
|
|
|
|
|
(108,296)
|
Remeasurement of defined benefit pension liability |
(79)
|
|
|
|
(79)
|
|
Foreign currency translation adjustment |
311
|
|
|
|
311
|
|
Other comprehensive (loss) income before share of other comprehensive loss in joint venture |
232
|
|
|
|
232
|
|
Share of other comprehensive loss in joint venture |
(700)
|
|
|
|
(700)
|
|
Other comprehensive loss |
(468)
|
|
|
|
(468)
|
|
Total comprehensive loss |
(108,764)
|
|
|
|
(468)
|
(108,296)
|
Vestings of RSUs |
0
|
|
(111)
|
$ 111
|
|
|
Vestings of RSUs (in shares) |
|
|
|
1,269,106
|
|
|
Issuance of shares, 2022 Employee Stock Purchase Plan |
425
|
|
414
|
$ 11
|
|
|
Issuance of shares, 2022 Employee Stock Purchase Plan (in shares) |
|
|
|
130,348
|
|
|
Share-based compensation expense |
9,192
|
|
9,192
|
|
|
|
Common stock, increase (decrease) (in shares) |
|
0
|
|
1,399,454
|
|
|
Stockholders' equity, excluding OCI, increase (decrease) |
9,617
|
$ 0
|
9,495
|
$ 122
|
|
|
Ending balance (in shares) at Jun. 30, 2023 |
|
89,041,946
|
|
|
|
|
Ending balance at Jun. 30, 2023 |
(19,696)
|
$ 7,312
|
1,175,909
|
$ (557)
|
1,355
|
(1,203,715)
|
Treasury stock, ending balance (in shares) at Jun. 30, 2023 |
|
|
|
(6,999,965)
|
|
|
Beginning balance (in shares) at Dec. 31, 2022 |
|
89,041,946
|
|
|
|
|
Beginning balance at Dec. 31, 2022 |
$ 79,451
|
$ 7,312
|
1,166,414
|
$ (679)
|
1,823
|
(1,095,419)
|
Treasury stock, beginning balance (in shares) at Dec. 31, 2022 |
|
|
|
(8,399,419)
|
|
|
Ending balance (in shares) at Dec. 31, 2023 |
82,293,137
|
89,041,946
|
|
|
|
|
Ending balance at Dec. 31, 2023 |
$ (148,249)
|
$ 7,312
|
1,180,545
|
$ (541)
|
(93)
|
(1,335,472)
|
Treasury stock, ending balance (in shares) at Dec. 31, 2023 |
(6,748,809)
|
|
|
(6,748,809)
|
|
|
Beginning balance (in shares) at Mar. 31, 2023 |
|
89,041,946
|
|
|
|
|
Beginning balance at Mar. 31, 2023 |
$ 28,422
|
$ 7,312
|
1,174,879
|
$ (645)
|
1,669
|
(1,154,793)
|
Treasury stock, beginning balance (in shares) at Mar. 31, 2023 |
|
|
|
(8,014,180)
|
|
|
Increase (Decrease) in Stockholders' Equity [Roll Forward] |
|
|
|
|
|
|
Loss for the period |
(48,922)
|
|
|
|
|
(48,922)
|
Remeasurement of defined benefit pension liability |
(40)
|
|
|
|
(40)
|
|
Foreign currency translation adjustment |
170
|
|
|
|
170
|
|
Other comprehensive (loss) income before share of other comprehensive loss in joint venture |
130
|
|
|
|
130
|
|
Share of other comprehensive loss in joint venture |
(444)
|
|
|
|
(444)
|
|
Other comprehensive loss |
(314)
|
|
|
|
(314)
|
|
Total comprehensive loss |
(49,236)
|
|
|
|
(314)
|
(48,922)
|
Vestings of RSUs |
0
|
|
(88)
|
$ 88
|
|
|
Vestings of RSUs (in shares) |
|
|
|
1,014,215
|
|
|
Share-based compensation expense |
1,118
|
|
1,118
|
|
|
|
Common stock, increase (decrease) (in shares) |
|
|
|
1,014,215
|
|
|
Stockholders' equity, excluding OCI, increase (decrease) |
1,118
|
|
1,030
|
$ 88
|
|
|
Ending balance (in shares) at Jun. 30, 2023 |
|
89,041,946
|
|
|
|
|
Ending balance at Jun. 30, 2023 |
$ (19,696)
|
$ 7,312
|
1,175,909
|
$ (557)
|
1,355
|
(1,203,715)
|
Treasury stock, ending balance (in shares) at Jun. 30, 2023 |
|
|
|
(6,999,965)
|
|
|
Beginning balance (in shares) at Dec. 31, 2023 |
82,293,137
|
89,041,946
|
|
|
|
|
Beginning balance at Dec. 31, 2023 |
$ (148,249)
|
$ 7,312
|
1,180,545
|
$ (541)
|
(93)
|
(1,335,472)
|
Treasury stock, beginning balance (in shares) at Dec. 31, 2023 |
(6,748,809)
|
|
|
(6,748,809)
|
|
|
Increase (Decrease) in Stockholders' Equity [Roll Forward] |
|
|
|
|
|
|
Loss for the period |
$ (83,150)
|
|
|
|
|
(83,150)
|
Remeasurement of defined benefit pension liability |
(81)
|
|
|
|
(81)
|
|
Foreign currency translation adjustment |
(61)
|
|
|
|
(61)
|
|
Other comprehensive (loss) income before share of other comprehensive loss in joint venture |
(142)
|
|
|
|
(142)
|
|
Share of other comprehensive loss in joint venture |
(103)
|
|
|
|
(103)
|
|
Other comprehensive loss |
(245)
|
|
|
|
(245)
|
|
Total comprehensive loss |
(83,395)
|
|
|
|
(245)
|
(83,150)
|
Vestings of RSUs |
0
|
|
(42)
|
$ 42
|
|
|
Vestings of RSUs (in shares) |
|
|
|
502,929
|
|
|
Exercise of options |
$ 74
|
|
72
|
$ 2
|
|
|
Exercise of options (in shares) |
31,988
|
|
|
31,988
|
|
|
Issuance of shares, 2022 Employee Stock Purchase Plan |
$ 323
|
|
305
|
$ 18
|
|
|
Issuance of shares, 2022 Employee Stock Purchase Plan (in shares) |
|
|
|
229,675
|
|
|
Issuance of shares, underwritten offering, net of transaction costs |
60,506
|
$ 921
|
59,345
|
$ 240
|
|
|
Issuance of shares, underwritten offering, net of transaction costs (in shares) |
|
10,411,912
|
|
3,000,000
|
|
|
Issuance of warrants, underwritten offering, net of transaction costs |
36,925
|
|
36,925
|
|
|
|
Share-based compensation expense |
2,146
|
|
2,146
|
|
|
|
Common stock, increase (decrease) (in shares) |
|
10,411,912
|
|
3,764,592
|
|
|
Stockholders' equity, excluding OCI, increase (decrease) |
$ 99,974
|
$ 921
|
98,751
|
$ 302
|
|
|
Ending balance (in shares) at Jun. 30, 2024 |
96,469,641
|
99,453,858
|
|
|
|
|
Ending balance at Jun. 30, 2024 |
$ (131,670)
|
$ 8,233
|
1,279,296
|
$ (239)
|
(338)
|
(1,418,622)
|
Treasury stock, ending balance (in shares) at Jun. 30, 2024 |
(2,984,217)
|
|
|
(2,984,217)
|
|
|
Beginning balance (in shares) at Mar. 31, 2024 |
|
89,041,946
|
|
|
|
|
Beginning balance at Mar. 31, 2024 |
$ (194,449)
|
$ 7,312
|
1,181,020
|
$ (502)
|
(201)
|
(1,382,078)
|
Treasury stock, beginning balance (in shares) at Mar. 31, 2024 |
|
|
|
(6,264,720)
|
|
|
Increase (Decrease) in Stockholders' Equity [Roll Forward] |
|
|
|
|
|
|
Loss for the period |
(36,544)
|
|
|
|
|
(36,544)
|
Remeasurement of defined benefit pension liability |
(81)
|
|
|
|
(81)
|
|
Foreign currency translation adjustment |
17
|
|
|
|
17
|
|
Other comprehensive (loss) income before share of other comprehensive loss in joint venture |
(64)
|
|
|
|
(64)
|
|
Share of other comprehensive loss in joint venture |
(73)
|
|
|
|
(73)
|
|
Other comprehensive loss |
(137)
|
|
|
|
(137)
|
|
Total comprehensive loss |
(36,681)
|
|
|
|
(137)
|
(36,544)
|
Vestings of RSUs |
0
|
|
(22)
|
$ 22
|
|
|
Vestings of RSUs (in shares) |
|
|
|
254,899
|
|
|
Exercise of options |
41
|
|
40
|
$ 1
|
|
|
Exercise of options (in shares) |
|
|
|
25,604
|
|
|
Issuance of shares, underwritten offering, net of transaction costs |
60,506
|
$ 921
|
59,345
|
$ 240
|
|
|
Issuance of shares, underwritten offering, net of transaction costs (in shares) |
|
10,411,912
|
|
3,000,000
|
|
|
Issuance of warrants, underwritten offering, net of transaction costs |
36,925
|
|
36,925
|
|
|
|
Share-based compensation expense |
1,988
|
|
1,988
|
|
|
|
Common stock, increase (decrease) (in shares) |
|
10,411,912
|
|
3,280,503
|
|
|
Stockholders' equity, excluding OCI, increase (decrease) |
$ 99,460
|
$ 921
|
98,276
|
$ 263
|
|
|
Ending balance (in shares) at Jun. 30, 2024 |
96,469,641
|
99,453,858
|
|
|
|
|
Ending balance at Jun. 30, 2024 |
$ (131,670)
|
$ 8,233
|
$ 1,279,296
|
$ (239)
|
$ (338)
|
$ (1,418,622)
|
Treasury stock, ending balance (in shares) at Jun. 30, 2024 |
(2,984,217)
|
|
|
(2,984,217)
|
|
|
X |
- DefinitionOther Comprehensive Income (Loss) Before OCI, Equity Method Investment, Net Of Tax, Portion Attributable to Parent
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v3.24.2.u1
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
12 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Cash used in operating activities |
|
|
|
|
|
Net loss |
$ (36,544)
|
$ (48,922)
|
$ (83,150)
|
$ (108,296)
|
|
Adjustments to reconcile net loss to net cash used in operations: |
|
|
|
|
|
Deferred income taxes |
|
|
0
|
(5,172)
|
|
Share-based compensation expense |
|
|
2,146
|
9,192
|
|
Accretion expense of deferred royalty obligation |
|
|
13,790
|
5,346
|
|
Amortization of debt discount, senior secured term loan |
|
|
943
|
1,503
|
|
Cumulative catch-up adjustment, deferred royalty obligation |
(263)
|
5,417
|
(526)
|
5,288
|
|
Write-downs of inventory |
288
|
727
|
1,036
|
780
|
|
Depreciation |
326
|
273
|
657
|
536
|
|
Amortization of operating lease right-of-use assets |
|
|
1,024
|
999
|
|
Share of results in joint venture |
597
|
767
|
1,284
|
2,130
|
|
Warrant obligations, increase (decrease) in fair value |
|
|
838
|
(636)
|
|
Other |
|
|
(240)
|
18
|
|
Changes in operating assets and liabilities: |
|
|
|
|
|
Accounts receivable, net |
|
|
2,314
|
49,089
|
|
Inventory |
|
|
(50)
|
(2,400)
|
|
Other current assets |
|
|
(859)
|
4,930
|
|
Other long-term assets |
|
|
(287)
|
200
|
|
Accounts payable |
|
|
(6,083)
|
(687)
|
|
Accrued expenses and other short-term liabilities |
|
|
(5,732)
|
(15,588)
|
|
Operating lease liabilities |
|
|
(1,028)
|
(714)
|
|
Other long-term liabilities |
|
|
(3,017)
|
3,102
|
|
Net cash used in operating activities |
|
|
(76,940)
|
(50,380)
|
|
Cash flows from investing activities |
|
|
|
|
|
Payment for purchases of property and equipment |
|
|
(561)
|
(2,228)
|
|
Net cash used in investing activities |
|
|
(561)
|
(2,228)
|
|
Cash flows provided by financing activities |
|
|
|
|
|
Proceeds from common shares, 2024 Equity Offering, net of transaction costs |
|
|
61,731
|
0
|
|
Proceeds from 2024 Pre-Funded Warrants, net of transaction costs |
|
|
36,925
|
0
|
|
Proceeds from deferred royalty transaction, net of transaction costs |
|
|
0
|
73,102
|
|
Proceeds from share issuance under stock purchase plan |
|
|
323
|
425
|
|
Proceeds from the exercise of stock options |
|
|
74
|
0
|
|
Net cash provided by financing activities |
|
|
99,053
|
73,527
|
|
Net increase in cash and cash equivalents |
|
|
21,552
|
20,919
|
|
Exchange (losses)/gains on cash and cash equivalents |
|
|
(31)
|
150
|
|
Cash and cash equivalents at beginning of period |
|
|
278,598
|
326,441
|
$ 326,441
|
Cash and cash equivalents at end of period |
$ 300,119
|
$ 347,510
|
300,119
|
347,510
|
$ 278,598
|
Supplemental Cash Flow Information: |
|
|
|
|
|
Interest paid |
|
|
7,874
|
7,522
|
|
Interest received |
|
|
7,635
|
5,167
|
|
Payments made under royalty financing transaction |
|
|
2,569
|
6,230
|
|
Supplemental Non-Cash Investing and Financing Activities: |
|
|
|
|
|
Transaction costs recorded in Accounts payable and other current liabilities |
|
|
1,225
|
0
|
|
Capital expenditures recorded in Accounts payable and Accrued expenses and other current liabilities |
|
|
$ 0
|
$ 270
|
|
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v3.24.2.u1
Description of Business and Organization
|
6 Months Ended |
Jun. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Description of Business and Organization |
Description of Business and Organization ADC Therapeutics is a leading, commercial-stage global pioneer in the field of antibody drug conjugates (“ADCs”) committed to advancing its proprietary ADC technology platform to transform the 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 and targets, a robust next-generation research and development toolbox, and specialized end-to-end capabilities. The Company generates sales from its flagship product, ZYNLONTA, which is currently approved in the U.S. for the treatment of relapsed or refractory diffuse large B-cell lymphoma (“DLBCL”) in the third-line setting and has also been granted conditional marketing authorization in Europe. Additionally, the Company is seeking to expand ZYNLONTA into earlier lines of therapy and indolent lymphomas, and is committed to advancing its portfolio and pipeline through its continued research, development, regulatory and commercialization activities.
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 three wholly-owned subsidiaries: ADC Therapeutics America, Inc. (“ADCT America”), which was incorporated in Delaware, USA on December 10, 2014, ADC Therapeutics (UK) Ltd (“ADCT UK”), which was incorporated in England on December 12, 2014 and ADC Therapeutics (NL) B.V. which was incorporated in the Netherlands on February 25, 2022. The Company and its three 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 unaudited condensed consolidated subsidiaries unless otherwise indicated.
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v3.24.2.u1
Summary of Significant Accounting Policies
|
6 Months Ended |
Jun. 30, 2024 |
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, 2023.
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 and six months ended June 30, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024, 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, 2023.
The Company is managed and operated as one business segment, focused on the global development and commercialization of targeted ADC cancer therapies. A single management team that reports to the chief operating decision-maker, the Chief Executive Officer, comprehensively manages and allocates resources at the global corporate level. Accordingly, the Company views its business and manages its operations as a single operating segment.
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 unaudited condensed 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.
Going Concern
We are responsible for evaluating, and providing disclosure of uncertainties about, our ability to continue as a going concern. As of June 30, 2024, we had cash and cash equivalents of $300.1 million. Based on our evaluation, we concluded there is no substantial doubt about our ability to continue as a going concern within one year from the date the unaudited condensed consolidated financial statements were issued.
Recent Accounting Pronouncements
New accounting pronouncements which have been adopted
There are no accounting pronouncements that the Company has recently adopted.
Issued but not yet adopted
In November 2023, the FASB amended guidance in ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The revised guidance requires that a public entity disclose significant segment expenses regularly reviewed by the chief operating decision maker (CODM), including public entities with a single reportable segment. The amended guidance is effective for fiscal years beginning in January 2024 and interim periods beginning January 2025 on a retrospective basis. Early adoption is permitted. The Company is currently evaluating the effect that adoption of ASU 2023-07 will have on its consolidated financial statements. 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.
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v3.24.2.u1
Fair value measurements
|
6 Months Ended |
Jun. 30, 2024 |
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. The estimated fair value of debt is based on Level 2 inputs, including our understanding of current market rates we could obtain for similar loans.
The Deerfield warrants, which are measured at fair value on a recurring basis, were as follows as of June 30, 2024 and December 31, 2023: | | | | | | | | | | | | | | | | | | | | | | | | | | | (in thousands) | | Total | | Quoted prices in active markets for identical assets and liabilities (Level 1) | | Other observable inputs (Level 2) | | Significant unobservable inputs (Level 3) | June 30, 2024: | | | | | | | | | Deerfield warrant obligation | | $ | 1,134 | | | $ | — | | | $ | 1,134 | | | $ | — | | | | | | | | | | | Total | | $ | 1,134 | | | $ | — | | | $ | 1,134 | | | $ | — | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | (in thousands) | | Total | | Quoted prices in active markets for identical assets and liabilities (Level 1) | | Other observable inputs (Level 2) | | Significant unobservable inputs (Level 3) | December 31, 2023: | | | | | | | | | Deerfield warrant obligation | | $ | 296 | | | $ | — | | | $ | 296 | | | $ | — | | | | | | | | | | | Total | | $ | 296 | | | $ | — | | | $ | 296 | | | $ | — | |
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 10, "Deerfield warrants." A Black-Scholes model was used to calculate the fair values. There were no transfers between the respective levels during the period.
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- DefinitionThe entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.
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v3.24.2.u1
Inventory
|
6 Months Ended |
Jun. 30, 2024 |
Inventory Disclosure [Abstract] |
|
Inventory |
Inventory As of June 30, 2024 and December 31, 2023 inventory consisted of the following: | | | | | | | | | | | | | | | (in thousands) | | June 30, 2024 | | December 31, 2023 | | | | | | Work in progress | | $ | 15,123 | | | $ | 16,095 | | Finished goods | | 68 | | | 82 | | Total inventory, net | | $ | 15,191 | | | $ | 16,177 | |
Inventory write-downs of $288 and $1,036 were recognized for the three and six months ended June 30, 2024, respectively, and $727 and $780 were recognized for the three and six months ended June 30, 2023, respectively, and charged to cost of product sales in the Company’s unaudited condensed consolidated statements of operations.
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v3.24.2.u1
Property and equipment
|
6 Months Ended |
Jun. 30, 2024 |
Property, Plant and Equipment [Abstract] |
|
Property and equipment |
Property and equipment Property and equipment as of June 30, 2024 and December 31, 2023 consisted of the following: | | | | | | | | | | | | | | | (in thousands) | | June 30, 2024 | | December 31, 2023 | Leasehold improvements | | $ | 3,905 | | | $ | 3,953 | | Laboratory equipment | | 4,154 | | | 3,652 | | Office equipment | | 977 | | | 1,119 | | Hardware and computer software | | 1,138 | | | 1,173 | | | | | | | | | 10,174 | | | 9,897 | | Less: accumulated depreciation | | (4,691) | | | (4,275) | | Property and equipment, net | | $ | 5,483 | | | $ | 5,622 | |
Depreciation expense was $326 and $657 for the three and six months ended June 30, 2024, respectively, and $273 and $536 for the three and six months ended June 30, 2023, respectively.
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v3.24.2.u1
Interest in joint venture
|
6 Months Ended |
Jun. 30, 2024 |
Equity Method Investments and Joint Ventures [Abstract] |
|
Interest in joint venture |
Interest in joint venture On December 14, 2020, the Company formed a new joint venture company, Overland ADCT BioPharma, with Overland Pharmaceuticals (“Overland”) to develop and commercialize ZYNLONTA, and three of the Company’s ADC product candidates, ADCT-601, ADCT-602 and ADCT-901 (collectively, the “Licensed Products”), in greater China and Singapore (the “Territory”). The table below provides a rollforward of the Company’s interest in Overland ADCT BioPharma as of June 30, 2024 and December 31, 2023. | | | | | | | | | (in thousands) | | | Interest in joint venture | | | January 1, 2023 | | $ | 7,613 | | Share of comprehensive loss in joint venture | | (5,966) | | December 31, 2023 | | $ | 1,647 | | Share of comprehensive loss in joint venture | | (1,387) | | June 30, 2024 | | $ | 260 | |
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v3.24.2.u1
Income taxes
|
6 Months Ended |
Jun. 30, 2024 |
Income Tax Disclosure [Abstract] |
|
Income taxes |
Income taxes Income tax expense for the three and six months ended June 30, 2024 was $0.2 million and $0.4 million, respectively, relative to loss before income taxes of $35.7 million and $81.5 million, respectively. The income tax benefit for the three and six months ended June 30, 2023 was $4.5 million and $4.0 million, respectively, relative to loss before income taxes of $52.7 million and $110.1 million, respectively. The expense for the three and six months ended June 30, 2024 is 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. Whereas the benefit for the three and six months ended June 30, 2023 was the result of income generated in the U.S. and UK. The decrease in income for the US operations is due to a change in the Company operating and transfer pricing model which was implemented in October 2023. 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.
|
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- DefinitionThe entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.
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v3.24.2.u1
Accrued expenses and other current liabilities
|
6 Months Ended |
Jun. 30, 2024 |
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: | | | | | | | | | | | | | | | (in thousands) | | June 30, 2024 | | December 31, 2023 | Accrued R&D costs | | $ | 18,304 | | | $ | 24,902 | | Accrued payroll and benefits | | 8,088 | | | 12,693 | | | | | | | Gross-to-net sales adjustments, short-term | | 8,180 | | | 1,543 | | Operating lease liabilities, short-term | | 1,415 | | | 1,467 | | Other | | 10,937 | | | 11,496 | | | | $ | 46,924 | | | $ | 52,101 | |
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- DefinitionThe entire disclosure for supplemental balance sheet disclosures, including descriptions and amounts for assets, liabilities, and equity.
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v3.24.2.u1
Senior secured term loan facility
|
6 Months Ended |
Jun. 30, 2024 |
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 and six months ended June 30, 2024, the Company recorded interest expense on the senior secured term loan in the amount of $4,413 and $8,816, respectively, and $4,480 and $9,020 for the three and six months ended June 30, 2023, respectively, which was recorded in interest expense in the unaudited condensed consolidated statements of operations. The effective interest rate (“EIR”) at June 30, 2024 was 16.83%.
The following table provides a summary of the interest expense for the Company’s senior secured term loan for the three months ended June 30, 2024 and 2023:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three months ended June 30, | | Six months ended June 30, | | | 2024 | | 2023 | | 2024 | | 2023 | Contractual interest expense | | $ | 3,973 | | | $ | 3,807 | | | $ | 7,873 | | | $ | 7,517 | | Amortization of debt discount | | 440 | | | 673 | | | 943 | | | 1,503 | | Total | | $ | 4,413 | | | $ | 4,480 | | | $ | 8,816 | | | $ | 9,020 | |
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 $113.7 million and $112.7 million as of June 30, 2024 and December 31, 2023, respectively.
Contractual payments due under our senior secured term loans, including exit fees are as follows (in thousands):
| | | | | | | | | 2024 (remainder) | | $ | — | | 2025 | | — | | 2026 | | 3,090 | | 2027 | | 9,330 | | 2028 | | 12,480 | | Thereafter | | 99,840 | | Total | | $ | 124,740 | |
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- DefinitionThe entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.
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v3.24.2.u1
Deerfield warrants
|
6 Months Ended |
Jun. 30, 2024 |
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 (gains or losses) of the warrant obligation at the end of each period are recorded in the unaudited condensed consolidated statements of operations.
During the three and six months ended June 30, 2024, the Company recognized income (expense) of $2,230 and $(838), respectively, and $20 and $636 for the three and six months ended June 30, 2023, respectively, as a result of changes in the fair value of the warrant obligation. The fair value of the warrant obligation as of June 30, 2024 and December 31, 2023 was $1,134 and $296, respectively. The increase in fair value of the warrant obligation from December 31, 2023 to June 30, 2024 was primarily due to the increase in the fair value of the underlying shares during the respective period. This amount was recorded to Other, net in the unaudited condensed consolidated statements of operations. See note 16, "Other income (expense)" for further information.
The Company used a third-party valuation firm to assist in calculating the fair value of the Deerfield warrant obligation, using the Black-Scholes option-pricing model. Key inputs for the valuation of the warrant obligation as of June 30, 2024 and December 31, 2023 were as follows:
| | | | | | | | | | | | | As of | | As of | | June 30, 2024 | | December 31, 2023 | Exercise price in $ | 24.70 and 28.07 | | 24.70 and 28.07 | Share price in $ | 3.16 | | | 1.66 | | Risk-free interest rate | 5.1 | % | | 4.6 | % | Expected volatility | 140.6 | % | | 116.0 | % | Expected term (months) | 10.7 months | | 16.7 months | Dividend yield | — | | | — | | Black-Scholes value in $ | 0.27 and 0.23 | | 0.07 and 0.06 |
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v3.24.2.u1
Deferred royalty obligation
|
6 Months Ended |
Jun. 30, 2024 |
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. | | | | | | | | | (in thousands) | | | Liability balance at January 1, 2023 | | $ | 222,277 | | Plus: Additional proceeds from the sale of future royalties | | 75,000 | | Less: Transaction costs | | 1,898 | | Less: royalty payments | | 8,709 | | Plus: interest expense | | 27,915 | | Less: cumulative catch-up adjustment, Other, net | | 4,972 | | Liability balance at December 31, 2023 | | 309,613 | | | | | Less: royalty payments | | 2,569 | | Plus: interest expense | | 16,359 | | Less: cumulative catch-up adjustment, Other, net | | 526 | | Liability balance at June 30, 2024 | | $ | 322,877 | |
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v3.24.2.u1
Pension and post-retirement benefit obligations
|
6 Months Ended |
Jun. 30, 2024 |
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 and six months ended June 30, 2024 and 2023 is as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three months ended June 30, | | Six months ended June 30, | (in thousands) | | 2024 | | 2023 | | 2024 | | 2023 | Net periodic benefit cost: | | | | | | | | | Service cost | | $ | 183 | | | $ | 275 | | | $ | 347 | | | $ | 447 | | Interest cost | | 37 | | | 75 | | | 75 | | | 149 | | Expected return on plan assets | | (59) | | | (83) | | | (118) | | | (165) | | Amortization of prior service cost | | (40) | | | (40) | | | (81) | | | (79) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Net periodic benefit cost | | $ | 121 | | | $ | 227 | | | $ | 223 | | | $ | 352 | |
The components of net periodic benefit cost are included in operating expense on the unaudited condensed consolidated statements of operations.
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v3.24.2.u1
Commitments and contingencies
|
6 Months Ended |
Jun. 30, 2024 |
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, 2023. 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 unaudited condensed consolidated financial condition, liquidity, or results of operation.
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v3.24.2.u1
Shareholders' equity
|
6 Months Ended |
Jun. 30, 2024 |
Equity [Abstract] |
|
Shareholders' equity |
Shareholders’ equity 2024 Equity Offering
In May 2024, the Company completed an underwritten offering of equity securities in which 13,411,912 of the Company’s common shares were sold to public investors at a price of $4.90 per share and pre-funded warrants (the “2024 Pre-Funded Warrants”) to purchase 8,163,265 of the Company’s common shares were sold to public investors at a price of $4.81 per pre-funded warrant, which equals the per share 2024 Equity Offering price, less the CHF 0.08 exercise price for each pre-funded warrant (collectively, the “2024 Equity Offering”). Gross proceeds from the 2024 Equity Offering were approximately $105.0 million, and, after giving effect to $7.6 million of transaction costs related to the offering, net proceeds were approximately $97.4 million.
The 2024 Pre-Funded Warrants are exercisable, on a cash basis (or, if there is no registration statement and current prospectus covering the issuance of the shares upon exercise, then on a cashless basis), at the option of the holder after the date of issuance until the tenth anniversary of their original issuance. At any time during the last 90 days of the term, the holder may exchange the Pre-Funded Warrant for, and we will issue, a new pre-funded warrant for the number of common shares then remaining under the Pre-Funded Warrant. The Pre-Funded Warrants have certain limitations on exercise, including (i) any exercise must be for at least 50,000 common shares (or, if less, the remaining common shares available for purchase under the Pre-Funded Warrants), (ii) a holder cannot exercise for any amount that would cause such holder’s beneficial ownership of our common shares to exceed 9.99% (or 19.99% with 61-days’ notice to us), and (iii) cashless exercise is not available in certain circumstances as specified in the Pre-Funded Warrants. The warrants contain customary anti-dilution adjustments and will entitle holders to receive any dividends or other distributions paid on the underlying common shares prior to their expiration on an as-exercised basis.
Accounting for the 2024 Equity Offering and Pre-Funded Warrants
The Company has accounted for the common shares and 2024 Pre-funded Warrants described above each as freestanding financial instruments.
The common shares were issued from the Company’s share capital and treasury shares at par value. The common shares were recorded as $60.5 million to equity for the issuance of the common shares, net of transaction costs accrued and paid, and an increase in cash and cash equivalents.
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, including the warrant holders cannot require “net cash settlement” in a circumstance outside of the Company’s control, and there is sufficient authorized and unissued shares to settle the warrants. Accordingly, these warrants are recognized as $36.9 million in equity and accounted for as a component of additional paid-in capital at the time of issuance, net of transaction costs paid, and an increase in cash and cash equivalents. Transaction costs have been allocated to the warrants and the common shares based on the relative fair value method. Transaction costs associated to the warrants and common shares have been deducted from the respective instrument in equity.
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- DefinitionThe entire disclosure for equity.
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v3.24.2.u1
Revenue
|
6 Months Ended |
Jun. 30, 2024 |
Revenue from Contract with Customer [Abstract] |
|
Revenue |
Revenue The table below provides a disaggregation of revenues by type and customer location for the three and six months ended June 30, 2024 and 2023: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three months ended June 30, | | Six months ended June 30, | (in thousands) | | 2024 | | 2023 | | 2024 | | 2023 | Types of goods and services | | | | | | | | | Product revenue, net | | $ | 17,030 | | | $ | 19,197 | | | $ | 34,878 | | | $ | 38,150 | | | | | | | | | | | Royalties | | 380 | | | 86 | | | 585 | | | 125 | | Total revenue | | $ | 17,410 | | | $ | 19,283 | | | $ | 35,463 | | | $ | 38,275 | | | | | | | | | | | Customer Location | | | | | | | | | U.S. | | $ | 17,030 | | | $ | 19,197 | | | $ | 34,878 | | | $ | 38,150 | | EMEA(1) | | 380 | | | 86 | | | 585 | | | 125 | | | | | | | | | | | Total revenue | | $ | 17,410 | | | $ | 19,283 | | | $ | 35,463 | | | $ | 38,275 | |
(1) Europe, the Middle East and Africa
Product revenue, net The table below provides a rollforward of the Company’s accruals related to the GTN sales adjustments for the three and six months ended June 30, 2024:
| | | | | | | | | | | | | | | | | | | | | (in thousands) | | Discarded Drug Rebate | | Other Adjustments | | Total | Balance as of April 1, 2024 | | $ | 9,393 | | | $ | 3,768 | | | $ | 13,161 | | GTN accruals for current period | | 1,858 | | | 3,759 | | | 5,617 | | Prior period adjustments | | — | | | (791) | | | (791) | | Credits, payments and reclassifications | | — | | | (3,479) | | | (3,479) | | Balance as of June 30, 2024 | | $ | 11,251 | | | $ | 3,257 | | | $ | 14,508 | | | | | | | | | Balance as of January 1, 2024 | | $ | 7,391 | | | $ | 3,946 | | | $ | 11,337 | | GTN accruals for current period | | 3,904 | | | 8,217 | | | 12,121 | | Prior period adjustments | | (44) | | | (1,020) | | | (1,064) | | Credits, payments and reclassifications | | — | | | (7,886) | | | (7,886) | | Balance as of June 30, 2024 | | $ | 11,251 | | | $ | 3,257 | | | $ | 14,508 | |
The table below provides a rollforward of the Company’s accruals related to the GTN sales adjustments for the three and six months ended June 30, 2023: | | | | | | | | | | | | | | | | | | | | | (in thousands) | | Discarded Drug Rebate | | Other Adjustments | | Total | Balance as of April 1, 2023 | | $ | 1,316 | | | $ | 3,046 | | | $ | 4,362 | | GTN accruals for current period | | 1,485 | | | 4,298 | | | 5,783 | | Prior period adjustments | | — | | | (229) | | | (229) | | Credits, payments and reclassifications | | — | | | (4,182) | | | (4,182) | | Balance as of June 30, 2023 | | $ | 2,801 | | | $ | 2,933 | | | $ | 5,734 | | | | | | | | | Balance as of January 1, 2023 | | $ | — | | | $ | 3,746 | | | $ | 3,746 | | GTN accruals for current period | | 2,801 | | | 8,598 | | | 11,399 | | Prior period adjustments | | — | | | (877) | | | (877) | | Credits, payments and reclassifications | | — | | | (8,534) | | | (8,534) | | Balance as of June 30, 2023 | | $ | 2,801 | | | $ | 2,933 | | | $ | 5,734 | |
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 June 30, 2024 and December 31, 2023.
| | | | | | | | | | | | | | | (in thousands) | | June 30, 2024 | | December 31, 2023 | Accounts receivable, net | | $ | 2,424 | | | $ | 2,403 | | Other current and non-current liabilities | | 12,084 | | | 8,934 | | | | $ | 14,508 | | | $ | 11,337 | |
Customers from which we derive more than 10% of our total product revenues for the three and six months ended June 30, 2024 and 2023 are as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three months ended June 30, | | Six months ended June 30, | | | 2024 | | 2023 | | 2024 | | 2023 | McKesson | | 37 | % | | 38 | % | | 40 | % | | 38 | % | AmerisourceBergen Corporation | | 35 | % | | 37 | % | | 36 | % | | 37 | % | Cardinal Health | | 28 | % | | 25 | % | | 24 | % | | 25 | % |
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- DefinitionThe entire disclosure of revenue from contract with customer to transfer good or service and to transfer nonfinancial asset. Includes, but is not limited to, disaggregation of revenue, credit loss recognized from contract with customer, judgment and change in judgment related to contract with customer, and asset recognized from cost incurred to obtain or fulfill contract with customer. Excludes insurance and lease contracts.
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v3.24.2.u1
Other income (expense)
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6 Months Ended |
Jun. 30, 2024 |
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 $3.3 million and $6.2 million for the three and six months ended June 30, 2024, respectively, and $2.4 million and $4.5 million for the three and six months ended June 30, 2023, respectively. Interest Expense
The components of Interest expense for the three and six months ended June 30, 2024 and 2023 are as follows: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three months ended June 30, | | Six months ended June 30, | (in thousands) | | | | | | | | 2024 | | 2023 | | 2024 | | 2023 | | | | | | | | | | | | | | | | Deferred royalty obligation interest expense | | | | | | | | $ | 8,266 | | | $ | 5,829 | | | $ | 16,359 | | | $ | 11,575 | | Effective interest expense on senior secured term loan facility | | | | | | | | 4,413 | | | 4,480 | | | 8,816 | | | 9,020 | | Other interest expense | | | | | | | | — | | | — | | | — | | | 5 | | Interest expense | | | | | | | | $ | 12,679 | | | $ | 10,309 | | | $ | 25,175 | | | $ | 20,600 | |
Other, net
The components of Other, net for the three and six months ended June 30, 2024 and 2023 are as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three months ended June 30, | | Six months ended June 30, | (in thousands) | | | | 2024 | | 2023 | | 2024 | | 2023 | Deerfield warrant obligation, change in fair value income (expense) | | | | $ | 2,230 | | | $ | 20 | | | $ | (838) | | | $ | 636 | | Cumulative catch-up adjustment income (expense), deferred royalty obligation | | | | 263 | | | (5,417) | | | 526 | | | (5,288) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Exchange differences (loss) gain | | | | (59) | | | 15 | | | (96) | | | (37) | | R&D tax credit | | | | 320 | | | 315 | | | 567 | | | 455 | | Other, net | | | | $ | 2,754 | | | $ | (5,067) | | | $ | 159 | | | $ | (4,234) | |
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v3.24.2.u1
Share-based compensation
|
6 Months Ended |
Jun. 30, 2024 |
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 June 30, 2024, the Company has 4,806,185 common shares available for the future issuance of share-based equity awards.
As of June 30, 2024 and December 31, 2023, 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 $157,773 and $157,906, respectively. The amounts of expense (reversal) recognized for all awards for services received during the three and six months ended June 30, 2024 were $848 and $(133), respectively, and $1,010 and $8,987 during the three and six months ended June 30, 2023, respectively. 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. As of June 30, 2024, the Company has 2,833,459 common shares available for the future issuance of share-based equity awards. As of June 30, 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 $2,357. The amounts of expense for all awards recognized for services received during the three and six months ended June 30, 2024 was $975 and $2,038, respectively. 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 June 30, 2024, the Company has 688,800 common shares available for the future issuance of share-based equity awards under this plan. As of June 30, 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 $95. The amounts of expense for all awards recognized for services received during the three and six months ended June 30, 2024 was $95 under this plan. 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 and six months ended June 30, 2024 was $689 and $(745), respectively, and $(715) and $4,066 during the three and six months ended June 30, 2023, respectively. Movements in the number of awards outstanding under the Plans described above and their related weighted average strike prices are as follows: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 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, 2023 | | $11.00 | | 10,744,406 | | | 8.14 | | $ | — | | Granted | | 3.83 | | 540,400 | | | | | | Forfeited | | 10.50 | | (428,200) | | | | | | Expired | | 32.53 | | (866,595) | | | | | | Exercised | | 2.62 | | (31,988) | | | | | | Outstanding as of June 30, 2024 | | $9.23 | | 9,958,023 | | | 7.77 | | $ | — | |
As of June 30, 2024, 4,910,379 awards are vested and exercisable out of the total outstanding awards of 9,958,023 common shares. As of June 30, 2024, the weighted average strike price and weighted average remaining life for vested and exercisable awards is $14.18 and 6.93 years, respectively. Awards outstanding as of June 30, 2024 have expiration dates through 2034. The weighted average grant date fair value of the awards granted during the six months ended June 30, 2024 was $3.02. The aggregate intrinsic value of vested and exercisable options was zero. As of June 30, 2024, the unrecognized compensation cost related to 5,047,644 unvested share options expected to vest was $9.8 million. This unrecognized cost will be recognized over an estimated weighted-average amortization period of 1.53 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 Company used a third-party valuation firm to assist in calculating the fair value of the award grants per participant. The fair values of the options granted during the three and six months ended June 30, 2024 and 2023 were determined on the date of grant using the following assumptions: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three months ended June 30, | | Six months ended June 30, | | | | | 2024 | | 2023 | | 2024 | | 2023 | Share price, in $ | | | | 3.31-4.71 | | 1.96-2.38 | | 1.69-4.86 | | 1.96-5.45 | Strike price, in $ | | | | 3.31-4.71 | | 1.96-2.38 | | 1.69-4.86 | | 1.96-5.45 | Expected volatility, in % | | | | 95 | | 75-80 | | 95 | | | 75-80 | Award life, in years | | | | 6.08 | | 6.08 | | 6.08 | | 6.08 | Expected dividends | | | | — | | | — | | | — | | | — | | Risk-free interest rate, in % | | | | 4.24-4.54 | | 3.56-4.02 | | 3.75-4.54 | | 3.39-4.13 |
During the three and six months ended June 30, 2023, the expected volatility was based on the Company’s historical volatility and selected volatility determined by median values observed among other comparable public companies. Beginning in the third quarter of 2023, the Company’s expected volatility is no longer determined by values observed among other comparable companies and is now based on the Company’s historical volatility. 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 two 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 and six months ended June 30, 2024 is $1,229 and $2,745, respectively, and $1,725 and $4,921 during the three and six months ended June 30, 2023, respectively.
The following table summarizes the RSU awards outstanding as of June 30, 2024: | | | | | | | | | | | | | Number of awards | | Weighted average grant date fair value (in $ per share) | | | | | | | | | | | | | | | | | December 31, 2023 | 6,533,843 | | | $2.03 | Granted | 280,000 | | | 3.16 | Vested | (502,929) | | | 9.17 | Forfeited | (521,038) | | | 1.88 | June 30, 2024 (1) | 5,789,876 | | | $1.48 |
(1) Includes 5,166,541 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 six months ended June 30, 2024 was $2.1 million. 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 expense recognized related to the ESPP during the three and six months ended June 30, 2024 is $70 and $146, respectively, and $108 and $205 during the three and six months ended June 30, 2023, respectively.
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Loss per share
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6 Months Ended |
Jun. 30, 2024 |
Earnings Per Share [Abstract] |
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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 and pre-funded warrants outstanding during the period, excluding common shares owned by the Company and held as treasury shares, as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three months ended June 30, | | Six months ended June 30, | | | (in thousands, except per share amounts) | | 2024 | | 2023 | | 2024 | | 2023 | | | Net loss | | $ | (36,544) | | | $ | (48,922) | | | $ | (83,150) | | | $ | (108,296) | | | | Weighted average number of shares outstanding | | 95,691,245 | | | 81,471,127 | | | 89,121,783 | | | 81,140,287 | | | | Basic and diluted loss per share | | $ | (0.38) | | | $ | (0.60) | | | $ | (0.93) | | | $ | (1.33) | | | |
For the three and six months ended June 30, 2024 and 2023, basic and diluted loss per share is calculated on the weighted average number of shares issued and outstanding and excludes shares to be issued under the Equity Incentive Plan 2019, Conditional Share Capital Plan, Inducement Plan, the Company’s warrant agreements and 2022 ESPP as the effect of including those shares would be anti-dilutive. See note 9, “Senior secured term loan facility,” note 10, “Deerfield warrants”, note 14, “Shareholders’ equity”, and note 17, “Share-based compensation expense,” 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: | | | | | | | | | | | | | | | | | | | Six months ended June 30, | | | | | 2024 | | 2023 | | | 2019 Equity Incentive Plan - Share Options | | 9,269,223 | | | 11,293,279 | | | | Inducement Plan - Share Options | | 688,800 | | | — | | | | 2019 Equity Incentive Plan - RSUs | | 623,335 | | | 1,108,899 | | | | Conditional Share Capital Plan - RSUs | | 5,166,541 | | | — | | | | Outstanding warrants | | 4,940,135 | | | 4,940,135 | | | | | | | | | | | | | 20,688,034 | | | 17,342,313 | | | |
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v3.24.2.u1
Summary of Significant Accounting Policies (Policies)
|
6 Months Ended |
Jun. 30, 2024 |
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, 2023.
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 and six months ended June 30, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024, 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, 2023. The Company is managed and operated as one business segment, focused on the global development and commercialization of targeted ADC cancer therapies. A single management team that reports to the chief operating decision-maker, the Chief Executive Officer, comprehensively manages and allocates resources at the global corporate level. Accordingly, the Company views its business and manages its operations as a single operating segment.
|
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 unaudited condensed 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
New accounting pronouncements which have been adopted
There are no accounting pronouncements that the Company has recently adopted.
Issued but not yet adopted
In November 2023, the FASB amended guidance in ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The revised guidance requires that a public entity disclose significant segment expenses regularly reviewed by the chief operating decision maker (CODM), including public entities with a single reportable segment. The amended guidance is effective for fiscal years beginning in January 2024 and interim periods beginning January 2025 on a retrospective basis. Early adoption is permitted. The Company is currently evaluating the effect that adoption of ASU 2023-07 will have on its consolidated financial statements. 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.
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v3.24.2.u1
Fair value measurements (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Fair Value Disclosures [Abstract] |
|
Schedule of Fair Value, Liabilities Measured on Recurring Basis |
The Deerfield warrants, which are measured at fair value on a recurring basis, were as follows as of June 30, 2024 and December 31, 2023: | | | | | | | | | | | | | | | | | | | | | | | | | | | (in thousands) | | Total | | Quoted prices in active markets for identical assets and liabilities (Level 1) | | Other observable inputs (Level 2) | | Significant unobservable inputs (Level 3) | June 30, 2024: | | | | | | | | | Deerfield warrant obligation | | $ | 1,134 | | | $ | — | | | $ | 1,134 | | | $ | — | | | | | | | | | | | Total | | $ | 1,134 | | | $ | — | | | $ | 1,134 | | | $ | — | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | (in thousands) | | Total | | Quoted prices in active markets for identical assets and liabilities (Level 1) | | Other observable inputs (Level 2) | | Significant unobservable inputs (Level 3) | December 31, 2023: | | | | | | | | | Deerfield warrant obligation | | $ | 296 | | | $ | — | | | $ | 296 | | | $ | — | | | | | | | | | | | Total | | $ | 296 | | | $ | — | | | $ | 296 | | | $ | — | |
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v3.24.2.u1
Inventory (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Inventory Disclosure [Abstract] |
|
Schedule of Inventory |
As of June 30, 2024 and December 31, 2023 inventory consisted of the following: | | | | | | | | | | | | | | | (in thousands) | | June 30, 2024 | | December 31, 2023 | | | | | | Work in progress | | $ | 15,123 | | | $ | 16,095 | | Finished goods | | 68 | | | 82 | | Total inventory, net | | $ | 15,191 | | | $ | 16,177 | |
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v3.24.2.u1
Property and equipment (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Property, Plant and Equipment [Abstract] |
|
Schedule of Property, Plant and Equipment |
Property and equipment as of June 30, 2024 and December 31, 2023 consisted of the following: | | | | | | | | | | | | | | | (in thousands) | | June 30, 2024 | | December 31, 2023 | Leasehold improvements | | $ | 3,905 | | | $ | 3,953 | | Laboratory equipment | | 4,154 | | | 3,652 | | Office equipment | | 977 | | | 1,119 | | Hardware and computer software | | 1,138 | | | 1,173 | | | | | | | | | 10,174 | | | 9,897 | | Less: accumulated depreciation | | (4,691) | | | (4,275) | | Property and equipment, net | | $ | 5,483 | | | $ | 5,622 | |
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v3.24.2.u1
Interest in joint venture (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Equity Method Investments and Joint Ventures [Abstract] |
|
Schedule of Equity Method Investments |
The table below provides a rollforward of the Company’s interest in Overland ADCT BioPharma as of June 30, 2024 and December 31, 2023. | | | | | | | | | (in thousands) | | | Interest in joint venture | | | January 1, 2023 | | $ | 7,613 | | Share of comprehensive loss in joint venture | | (5,966) | | December 31, 2023 | | $ | 1,647 | | Share of comprehensive loss in joint venture | | (1,387) | | June 30, 2024 | | $ | 260 | |
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v3.24.2.u1
Accrued expenses and other current liabilities (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
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: | | | | | | | | | | | | | | | (in thousands) | | June 30, 2024 | | December 31, 2023 | Accrued R&D costs | | $ | 18,304 | | | $ | 24,902 | | Accrued payroll and benefits | | 8,088 | | | 12,693 | | | | | | | Gross-to-net sales adjustments, short-term | | 8,180 | | | 1,543 | | Operating lease liabilities, short-term | | 1,415 | | | 1,467 | | Other | | 10,937 | | | 11,496 | | | | $ | 46,924 | | | $ | 52,101 | |
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v3.24.2.u1
Senior secured term loan facility (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
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 June 30, 2024 and 2023:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three months ended June 30, | | Six months ended June 30, | | | 2024 | | 2023 | | 2024 | | 2023 | Contractual interest expense | | $ | 3,973 | | | $ | 3,807 | | | $ | 7,873 | | | $ | 7,517 | | Amortization of debt discount | | 440 | | | 673 | | | 943 | | | 1,503 | | Total | | $ | 4,413 | | | $ | 4,480 | | | $ | 8,816 | | | $ | 9,020 | |
|
Schedule of Maturities of Long-Term Debt |
Contractual payments due under our senior secured term loans, including exit fees are as follows (in thousands):
| | | | | | | | | 2024 (remainder) | | $ | — | | 2025 | | — | | 2026 | | 3,090 | | 2027 | | 9,330 | | 2028 | | 12,480 | | Thereafter | | 99,840 | | Total | | $ | 124,740 | |
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v3.24.2.u1
Deerfield warrants (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Other Liabilities Disclosure [Abstract] |
|
Schedule of Fair Value Measurement Inputs and Valuation Techniques |
Key inputs for the valuation of the warrant obligation as of June 30, 2024 and December 31, 2023 were as follows: | | | | | | | | | | | | | As of | | As of | | June 30, 2024 | | December 31, 2023 | Exercise price in $ | 24.70 and 28.07 | | 24.70 and 28.07 | Share price in $ | 3.16 | | | 1.66 | | Risk-free interest rate | 5.1 | % | | 4.6 | % | Expected volatility | 140.6 | % | | 116.0 | % | Expected term (months) | 10.7 months | | 16.7 months | Dividend yield | — | | | — | | Black-Scholes value in $ | 0.27 and 0.23 | | 0.07 and 0.06 |
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v3.24.2.u1
Deferred royalty obligation (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
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. | | | | | | | | | (in thousands) | | | Liability balance at January 1, 2023 | | $ | 222,277 | | Plus: Additional proceeds from the sale of future royalties | | 75,000 | | Less: Transaction costs | | 1,898 | | Less: royalty payments | | 8,709 | | Plus: interest expense | | 27,915 | | Less: cumulative catch-up adjustment, Other, net | | 4,972 | | Liability balance at December 31, 2023 | | 309,613 | | | | | Less: royalty payments | | 2,569 | | Plus: interest expense | | 16,359 | | Less: cumulative catch-up adjustment, Other, net | | 526 | | Liability balance at June 30, 2024 | | $ | 322,877 | |
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v3.24.2.u1
Pension and post-retirement benefit obligations (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Retirement Benefits [Abstract] |
|
Schedule of Net Benefit Costs |
The net periodic benefit cost for the three and six months ended June 30, 2024 and 2023 is as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three months ended June 30, | | Six months ended June 30, | (in thousands) | | 2024 | | 2023 | | 2024 | | 2023 | Net periodic benefit cost: | | | | | | | | | Service cost | | $ | 183 | | | $ | 275 | | | $ | 347 | | | $ | 447 | | Interest cost | | 37 | | | 75 | | | 75 | | | 149 | | Expected return on plan assets | | (59) | | | (83) | | | (118) | | | (165) | | Amortization of prior service cost | | (40) | | | (40) | | | (81) | | | (79) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Net periodic benefit cost | | $ | 121 | | | $ | 227 | | | $ | 223 | | | $ | 352 | |
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v3.24.2.u1
Revenue (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
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 and six months ended June 30, 2024 and 2023: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three months ended June 30, | | Six months ended June 30, | (in thousands) | | 2024 | | 2023 | | 2024 | | 2023 | Types of goods and services | | | | | | | | | Product revenue, net | | $ | 17,030 | | | $ | 19,197 | | | $ | 34,878 | | | $ | 38,150 | | | | | | | | | | | Royalties | | 380 | | | 86 | | | 585 | | | 125 | | Total revenue | | $ | 17,410 | | | $ | 19,283 | | | $ | 35,463 | | | $ | 38,275 | | | | | | | | | | | Customer Location | | | | | | | | | U.S. | | $ | 17,030 | | | $ | 19,197 | | | $ | 34,878 | | | $ | 38,150 | | EMEA(1) | | 380 | | | 86 | | | 585 | | | 125 | | | | | | | | | | | Total revenue | | $ | 17,410 | | | $ | 19,283 | | | $ | 35,463 | | | $ | 38,275 | |
(1) Europe, the Middle East and Africa The table below provides a rollforward of the Company’s accruals related to the GTN sales adjustments for the three and six months ended June 30, 2024:
| | | | | | | | | | | | | | | | | | | | | (in thousands) | | Discarded Drug Rebate | | Other Adjustments | | Total | Balance as of April 1, 2024 | | $ | 9,393 | | | $ | 3,768 | | | $ | 13,161 | | GTN accruals for current period | | 1,858 | | | 3,759 | | | 5,617 | | Prior period adjustments | | — | | | (791) | | | (791) | | Credits, payments and reclassifications | | — | | | (3,479) | | | (3,479) | | Balance as of June 30, 2024 | | $ | 11,251 | | | $ | 3,257 | | | $ | 14,508 | | | | | | | | | Balance as of January 1, 2024 | | $ | 7,391 | | | $ | 3,946 | | | $ | 11,337 | | GTN accruals for current period | | 3,904 | | | 8,217 | | | 12,121 | | Prior period adjustments | | (44) | | | (1,020) | | | (1,064) | | Credits, payments and reclassifications | | — | | | (7,886) | | | (7,886) | | Balance as of June 30, 2024 | | $ | 11,251 | | | $ | 3,257 | | | $ | 14,508 | |
The table below provides a rollforward of the Company’s accruals related to the GTN sales adjustments for the three and six months ended June 30, 2023: | | | | | | | | | | | | | | | | | | | | | (in thousands) | | Discarded Drug Rebate | | Other Adjustments | | Total | Balance as of April 1, 2023 | | $ | 1,316 | | | $ | 3,046 | | | $ | 4,362 | | GTN accruals for current period | | 1,485 | | | 4,298 | | | 5,783 | | Prior period adjustments | | — | | | (229) | | | (229) | | Credits, payments and reclassifications | | — | | | (4,182) | | | (4,182) | | Balance as of June 30, 2023 | | $ | 2,801 | | | $ | 2,933 | | | $ | 5,734 | | | | | | | | | Balance as of January 1, 2023 | | $ | — | | | $ | 3,746 | | | $ | 3,746 | | GTN accruals for current period | | 2,801 | | | 8,598 | | | 11,399 | | Prior period adjustments | | — | | | (877) | | | (877) | | Credits, payments and reclassifications | | — | | | (8,534) | | | (8,534) | | Balance as of June 30, 2023 | | $ | 2,801 | | | $ | 2,933 | | | $ | 5,734 | |
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 June 30, 2024 and December 31, 2023.
| | | | | | | | | | | | | | | (in thousands) | | June 30, 2024 | | December 31, 2023 | Accounts receivable, net | | $ | 2,424 | | | $ | 2,403 | | Other current and non-current liabilities | | 12,084 | | | 8,934 | | | | $ | 14,508 | | | $ | 11,337 | |
|
Schedule of Product Revenue by Customer |
Customers from which we derive more than 10% of our total product revenues for the three and six months ended June 30, 2024 and 2023 are as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three months ended June 30, | | Six months ended June 30, | | | 2024 | | 2023 | | 2024 | | 2023 | McKesson | | 37 | % | | 38 | % | | 40 | % | | 38 | % | AmerisourceBergen Corporation | | 35 | % | | 37 | % | | 36 | % | | 37 | % | Cardinal Health | | 28 | % | | 25 | % | | 24 | % | | 25 | % |
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v3.24.2.u1
Other income (expense) (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Other Income and Expenses [Abstract] |
|
Schedule of Interest Expense |
The components of Interest expense for the three and six months ended June 30, 2024 and 2023 are as follows: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three months ended June 30, | | Six months ended June 30, | (in thousands) | | | | | | | | 2024 | | 2023 | | 2024 | | 2023 | | | | | | | | | | | | | | | | Deferred royalty obligation interest expense | | | | | | | | $ | 8,266 | | | $ | 5,829 | | | $ | 16,359 | | | $ | 11,575 | | Effective interest expense on senior secured term loan facility | | | | | | | | 4,413 | | | 4,480 | | | 8,816 | | | 9,020 | | Other interest expense | | | | | | | | — | | | — | | | — | | | 5 | | Interest expense | | | | | | | | $ | 12,679 | | | $ | 10,309 | | | $ | 25,175 | | | $ | 20,600 | |
|
Schedule of Other, Net |
The components of Other, net for the three and six months ended June 30, 2024 and 2023 are as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three months ended June 30, | | Six months ended June 30, | (in thousands) | | | | 2024 | | 2023 | | 2024 | | 2023 | Deerfield warrant obligation, change in fair value income (expense) | | | | $ | 2,230 | | | $ | 20 | | | $ | (838) | | | $ | 636 | | Cumulative catch-up adjustment income (expense), deferred royalty obligation | | | | 263 | | | (5,417) | | | 526 | | | (5,288) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Exchange differences (loss) gain | | | | (59) | | | 15 | | | (96) | | | (37) | | R&D tax credit | | | | 320 | | | 315 | | | 567 | | | 455 | | Other, net | | | | $ | 2,754 | | | $ | (5,067) | | | $ | 159 | | | $ | (4,234) | |
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v3.24.2.u1
Share-based compensation (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
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: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 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, 2023 | | $11.00 | | 10,744,406 | | | 8.14 | | $ | — | | Granted | | 3.83 | | 540,400 | | | | | | Forfeited | | 10.50 | | (428,200) | | | | | | Expired | | 32.53 | | (866,595) | | | | | | Exercised | | 2.62 | | (31,988) | | | | | | Outstanding as of June 30, 2024 | | $9.23 | | 9,958,023 | | | 7.77 | | $ | — | |
|
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions |
The fair values of the options granted during the three and six months ended June 30, 2024 and 2023 were determined on the date of grant using the following assumptions: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three months ended June 30, | | Six months ended June 30, | | | | | 2024 | | 2023 | | 2024 | | 2023 | Share price, in $ | | | | 3.31-4.71 | | 1.96-2.38 | | 1.69-4.86 | | 1.96-5.45 | Strike price, in $ | | | | 3.31-4.71 | | 1.96-2.38 | | 1.69-4.86 | | 1.96-5.45 | Expected volatility, in % | | | | 95 | | 75-80 | | 95 | | | 75-80 | Award life, in years | | | | 6.08 | | 6.08 | | 6.08 | | 6.08 | Expected dividends | | | | — | | | — | | | — | | | — | | Risk-free interest rate, in % | | | | 4.24-4.54 | | 3.56-4.02 | | 3.75-4.54 | | 3.39-4.13 |
|
Schedule of Share-Based Payment Arrangement, Restricted Stock Unit, Activity |
The following table summarizes the RSU awards outstanding as of June 30, 2024: | | | | | | | | | | | | | Number of awards | | Weighted average grant date fair value (in $ per share) | | | | | | | | | | | | | | | | | December 31, 2023 | 6,533,843 | | | $2.03 | Granted | 280,000 | | | 3.16 | Vested | (502,929) | | | 9.17 | Forfeited | (521,038) | | | 1.88 | June 30, 2024 (1) | 5,789,876 | | | $1.48 |
(1) Includes 5,166,541 RSUs outstanding in connection with the Conditional Share Capital Pan.
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v3.24.2.u1
Loss per share (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
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 and pre-funded warrants outstanding during the period, excluding common shares owned by the Company and held as treasury shares, as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three months ended June 30, | | Six months ended June 30, | | | (in thousands, except per share amounts) | | 2024 | | 2023 | | 2024 | | 2023 | | | Net loss | | $ | (36,544) | | | $ | (48,922) | | | $ | (83,150) | | | $ | (108,296) | | | | Weighted average number of shares outstanding | | 95,691,245 | | | 81,471,127 | | | 89,121,783 | | | 81,140,287 | | | | Basic and diluted loss per share | | $ | (0.38) | | | $ | (0.60) | | | $ | (0.93) | | | $ | (1.33) | | | |
|
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: | | | | | | | | | | | | | | | | | | | Six months ended June 30, | | | | | 2024 | | 2023 | | | 2019 Equity Incentive Plan - Share Options | | 9,269,223 | | | 11,293,279 | | | | Inducement Plan - Share Options | | 688,800 | | | — | | | | 2019 Equity Incentive Plan - RSUs | | 623,335 | | | 1,108,899 | | | | Conditional Share Capital Plan - RSUs | | 5,166,541 | | | — | | | | Outstanding warrants | | 4,940,135 | | | 4,940,135 | | | | | | | | | | | | | 20,688,034 | | | 17,342,313 | | | |
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v3.24.2.u1
Fair value measurements (Details) - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Deerfield warrant obligation |
$ 1,134
|
$ 296
|
Total |
1,134
|
296
|
Quoted prices in active markets for identical assets and liabilities (Level 1) |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Deerfield warrant obligation |
0
|
0
|
Total |
0
|
0
|
Other observable inputs (Level 2) |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Deerfield warrant obligation |
1,134
|
296
|
Total |
1,134
|
296
|
Significant unobservable inputs (Level 3) |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Deerfield warrant obligation |
0
|
0
|
Total |
$ 0
|
$ 0
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Jun. 30, 2024 |
Dec. 31, 2023 |
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment |
$ 10,174
|
$ 9,897
|
Less: accumulated depreciation |
(4,691)
|
(4,275)
|
Property and equipment, net |
5,483
|
5,622
|
Leasehold improvements |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment |
3,905
|
3,953
|
Laboratory equipment |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment |
4,154
|
3,652
|
Office equipment |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment |
977
|
1,119
|
Hardware and computer software |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment |
$ 1,138
|
$ 1,173
|
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3 Months Ended |
6 Months Ended |
12 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
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|
|
|
|
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|
|
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|
|
|
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|
$ (767)
|
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|
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|
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|
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260
|
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$ 1,647
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|
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|
|
|
|
|
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|
|
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|
$ 7,613
|
7,613
|
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|
|
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|
|
(5,966)
|
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$ 260
|
|
$ 260
|
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3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Income Tax Disclosure [Abstract] |
|
|
|
|
Income tax (expense) benefit |
$ 234
|
$ (4,498)
|
$ 397
|
$ (3,980)
|
Loss before income taxes |
$ 35,713
|
$ 52,653
|
$ 81,469
|
$ 110,146
|
v3.24.2.u1
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Jun. 30, 2024 |
Dec. 31, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
|
Accrued R&D costs |
$ 18,304
|
$ 24,902
|
Accrued payroll and benefits |
8,088
|
12,693
|
Gross-to-net sales adjustments, short-term |
8,180
|
1,543
|
Operating lease liabilities, short-term |
1,415
|
1,467
|
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10,937
|
11,496
|
Accrued expenses and other current liabilities |
$ 46,924
|
$ 52,101
|
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|
3 Months Ended |
6 Months Ended |
|
|
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Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
May 31, 2024 |
Dec. 31, 2023 |
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
Warrant exercise price (in dollars per share) |
|
|
|
|
|
$ 0.08
|
|
Issuance of shares (in shares) |
733,568
|
|
|
|
|
|
|
Senior secured term loans |
|
$ 113,673
|
|
$ 113,673
|
|
|
$ 112,730
|
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 |
|
4,413
|
$ 4,480
|
8,816
|
$ 9,020
|
|
|
Line of Credit | Loan Agreement | Secured Debt |
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
Face amount |
$ 175,000
|
|
|
|
|
|
|
Long-term debt |
$ 120,000
|
|
|
|
|
|
|
Interest expense on debt |
|
$ 4,413
|
$ 4,480
|
$ 8,816
|
$ 9,020
|
|
|
Debt effective interest rate |
|
16.83%
|
|
16.83%
|
|
|
|
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v3.24.2.u1
Senior secured term loan facility - Schedule of Interest Expense (Details) - Loan Agreement - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Debt Instrument [Line Items] |
|
|
|
|
Total |
$ 4,413
|
$ 4,480
|
$ 8,816
|
$ 9,020
|
Line of Credit | Secured Debt |
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
Contractual interest expense |
3,973
|
3,807
|
7,873
|
7,517
|
Amortization of debt discount |
440
|
673
|
943
|
1,503
|
Total |
$ 4,413
|
$ 4,480
|
$ 8,816
|
$ 9,020
|
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v3.24.2.u1
Deerfield warrants - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands |
|
3 Months Ended |
6 Months Ended |
|
|
Aug. 15, 2022 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
May 31, 2024 |
Dec. 31, 2023 |
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
Warrant exercise price (in dollars per share) |
|
|
|
|
|
$ 0.08
|
|
Deerfield warrant obligation, change in fair value income (expense) |
|
|
|
$ (838)
|
$ 636
|
|
|
Deerfield warrant obligation |
|
$ 1,134
|
|
1,134
|
|
|
$ 296
|
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 income (expense) |
|
2,230
|
$ 20
|
(838)
|
$ 636
|
|
|
Deerfield warrant obligation |
|
$ 1,134
|
|
$ 1,134
|
|
|
$ 296
|
Warrants, Tranche One | Deerfield Warrants |
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
Warrants, Tranche Two | Deerfield Warrants |
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
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Jun. 30, 2024
$ / shares
|
Dec. 31, 2023
$ / shares
|
Share price in $ |
|
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Class of Warrant or Right [Line Items] |
|
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Warrants, measurement input |
3.16
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1.66
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Risk-free interest rate |
|
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Class of Warrant or Right [Line Items] |
|
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0.051
|
0.046
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|
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Class of Warrant or Right [Line Items] |
|
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1.406
|
1.160
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|
|
Class of Warrant or Right [Line Items] |
|
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Warrants, term |
10 months 21 days
|
16 months 21 days
|
Dividend yield |
|
|
Class of Warrant or Right [Line Items] |
|
|
Warrants, measurement input |
0
|
0
|
Minimum | Exercise price in $ |
|
|
Class of Warrant or Right [Line Items] |
|
|
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24.70
|
24.70
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|
|
Class of Warrant or Right [Line Items] |
|
|
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0.27
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0.07
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|
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|
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28.07
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28.07
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6 Months Ended |
12 Months Ended |
Jun. 30, 2024 |
Dec. 31, 2023 |
Deferred Royalty Obligation [Roll Forward] |
|
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Beginning balance |
$ 309,613
|
$ 222,277
|
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|
75,000
|
Less: Transaction costs |
|
1,898
|
Less: royalty payments |
2,569
|
8,709
|
Plus: interest expense |
16,359
|
27,915
|
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526
|
4,972
|
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1 Months Ended |
3 Months Ended |
6 Months Ended |
May 31, 2024
USD ($)
$ / shares
shares
|
Jun. 30, 2024
USD ($)
|
Jun. 30, 2024
USD ($)
|
Jun. 30, 2023
USD ($)
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
Warrant exercise price (in dollars per share) | $ / shares |
$ 0.08
|
|
|
|
Proceeds from common shares, 2024 Equity Offering, net of transaction costs |
|
|
$ 61,731
|
$ 0
|
Issuance of warrants, underwritten offering, net of transaction costs |
|
$ 36,925
|
$ 36,925
|
|
2024 Pre-Funded warrant |
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
Class of warrent or right, exchange term (in days) |
90 days
|
|
|
|
Class of warrant or right, outstanding (in shares) | shares |
50,000
|
|
|
|
Beneficial ownership maximum term (in days) |
61 days
|
|
|
|
2024 Pre-Funded warrant | Minimum |
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
Beneficial ownership (as a percent) |
0.0999
|
|
|
|
2024 Pre-Funded warrant | Maximum |
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
Beneficial ownership (as a percent) |
0.1999
|
|
|
|
2024 Equity Offering |
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
Sale of stock, issued (in shares) | shares |
13,411,912
|
|
|
|
Sale of stock, price (in dollars per share) | $ / shares |
$ 4.81
|
|
|
|
Sale of stock, amount |
$ 105,000
|
|
|
|
Sale of stock, transaction costs |
7,600
|
|
|
|
Proceeds from common shares, 2024 Equity Offering, net of transaction costs |
97,400
|
|
|
|
Additional paid in capital |
60,500
|
|
|
|
Issuance of warrants, underwritten offering, net of transaction costs |
$ 36,900
|
|
|
|
2024 Equity Offering | Common Stock |
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
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$ 4.90
|
|
|
|
2024 Equity Offering | 2024 Pre-Funded warrant |
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
Sale of stock, issued (in shares) | shares |
8,163,265
|
|
|
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v3.24.2.u1
Revenue - Schedule of Disaggregation of Revenues (Details) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Disaggregation of Revenue [Line Items] |
|
|
|
|
Revenues |
$ 17,410
|
$ 19,283
|
$ 35,463
|
$ 38,275
|
U.S. |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Revenues |
17,030
|
19,197
|
34,878
|
38,150
|
EMEA |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Revenues |
380
|
86
|
585
|
125
|
Product revenue, net |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Revenues |
17,030
|
19,197
|
34,878
|
38,150
|
Royalties |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Revenues |
$ 380
|
$ 86
|
$ 585
|
$ 125
|
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v3.24.2.u1
Revenue - Schedule of GTN Product Revenue, Net (Details) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
|
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Gross To Net Sales Adjustment Rollforward [Roll Forward] |
|
|
|
|
|
Balance as of April 1, 2024 |
$ 13,161
|
$ 4,362
|
$ 11,337
|
$ 3,746
|
|
GTN accruals for current period |
5,617
|
5,783
|
12,121
|
11,399
|
|
Prior period adjustments |
(791)
|
(229)
|
(1,064)
|
(877)
|
|
Credits, payments and reclassifications |
(3,479)
|
(4,182)
|
(7,886)
|
(8,534)
|
|
Balance as of June 30, 2024 |
14,508
|
5,734
|
14,508
|
5,734
|
|
Gross To Net Sales Adjustment [Abstract] |
|
|
|
|
|
Accounts receivable, net |
2,424
|
|
2,424
|
|
$ 2,403
|
Other current and non-current liabilities |
12,084
|
|
12,084
|
|
8,934
|
Gross to net sales adjustment |
14,508
|
5,734
|
14,508
|
5,734
|
11,337
|
Discarded Drug Rebate |
|
|
|
|
|
Gross To Net Sales Adjustment Rollforward [Roll Forward] |
|
|
|
|
|
Balance as of April 1, 2024 |
9,393
|
1,316
|
7,391
|
0
|
|
GTN accruals for current period |
1,858
|
1,485
|
3,904
|
2,801
|
|
Prior period adjustments |
0
|
0
|
(44)
|
0
|
|
Credits, payments and reclassifications |
0
|
0
|
0
|
0
|
|
Balance as of June 30, 2024 |
11,251
|
2,801
|
11,251
|
2,801
|
|
Gross To Net Sales Adjustment [Abstract] |
|
|
|
|
|
Gross to net sales adjustment |
11,251
|
2,801
|
11,251
|
2,801
|
7,391
|
Other Adjustments |
|
|
|
|
|
Gross To Net Sales Adjustment Rollforward [Roll Forward] |
|
|
|
|
|
Balance as of April 1, 2024 |
3,768
|
3,046
|
3,946
|
3,746
|
|
GTN accruals for current period |
3,759
|
4,298
|
8,217
|
8,598
|
|
Prior period adjustments |
(791)
|
(229)
|
(1,020)
|
(877)
|
|
Credits, payments and reclassifications |
(3,479)
|
(4,182)
|
(7,886)
|
(8,534)
|
|
Balance as of June 30, 2024 |
3,257
|
2,933
|
3,257
|
2,933
|
|
Gross To Net Sales Adjustment [Abstract] |
|
|
|
|
|
Gross to net sales adjustment |
$ 3,257
|
$ 2,933
|
$ 3,257
|
$ 2,933
|
$ 3,946
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Other income (expense) - Schedule of Interest Expense (Details) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Debt Instrument [Line Items] |
|
|
|
|
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$ 8,266
|
$ 5,829
|
$ 16,359
|
$ 11,575
|
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0
|
0
|
0
|
5
|
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12,679
|
10,309
|
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|
20,600
|
Loan Agreement |
|
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|
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|
|
|
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|
$ 4,480
|
$ 8,816
|
$ 9,020
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3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Debt Instrument [Line Items] |
|
|
|
|
Deerfield warrant obligation, change in fair value income (expense) |
|
|
$ 838
|
$ (636)
|
Cumulative catch-up adjustment income (expense), deferred royalty obligation |
$ 263
|
$ (5,417)
|
526
|
(5,288)
|
Exchange differences (loss) gain |
(59)
|
15
|
(96)
|
(37)
|
R&D tax credit |
320
|
315
|
567
|
455
|
Other, net |
2,754
|
(5,067)
|
159
|
(4,234)
|
Deerfield Warrants |
|
|
|
|
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|
|
|
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$ 838
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$ (636)
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v3.24.2.u1
Share-based compensation - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands |
1 Months Ended |
3 Months Ended |
6 Months Ended |
12 Months Ended |
Jun. 30, 2022 |
Nov. 30, 2019 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Share-based compensation expense |
|
|
$ 1,988
|
$ 1,118
|
$ 2,146
|
$ 9,192
|
|
Awards vested and exercisable (in shares) |
|
|
4,910,379
|
|
4,910,379
|
|
|
Outstanding (in shares) |
|
|
9,958,023
|
|
9,958,023
|
|
10,744,406
|
Weighted average strike price (in dollars per share) |
|
|
$ 14.18
|
|
$ 14.18
|
|
|
Weighted average remaining life |
|
|
|
|
6 years 11 months 4 days
|
|
|
Weighted average grant date fair value (in dollars per share) |
|
|
$ 3.02
|
|
$ 3.02
|
|
|
Nonvested (in shares) |
|
|
5,047,644
|
|
5,047,644
|
|
|
Unrecognized compensation costs |
|
|
$ 9,800
|
|
$ 9,800
|
|
|
Share Options |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Expense recognized |
|
|
689
|
(715)
|
$ (745)
|
4,066
|
|
Employee Stock Option |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Vesting percentage |
|
25.00%
|
|
|
|
|
|
Vesting period |
|
3 years
|
|
|
|
|
|
Award life for options granted |
|
10 years
|
|
|
|
|
|
Unrecognized share-based compensation cost, period of recognition |
|
|
|
|
1 year 6 months 10 days
|
|
|
Restricted Stock Units |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Fair value of shares vested |
|
|
|
|
$ 2,100
|
|
|
2019 Equity Incentive Plan |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Common shares reserved for future issuance (in shares) |
|
17,741,355
|
|
|
|
|
|
Share-based compensation expense |
|
|
|
|
157,773
|
|
$ 157,906
|
Expense recognized |
|
|
$ 848
|
1,010
|
$ (133)
|
8,987
|
|
2019 Equity Incentive Plan | Share Options |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Common shares reserved for future issuance (in shares) |
|
|
4,806,185
|
|
4,806,185
|
|
|
2019 Equity Incentive Plan | Restricted Stock Units |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Expense recognized |
|
|
$ 1,229
|
1,725
|
$ 2,745
|
4,921
|
|
2019 Equity Incentive Plan | Restricted Stock Units | Minimum |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Vesting period |
|
2 years
|
|
|
|
|
|
2019 Equity Incentive Plan | Restricted Stock Units | Maximum |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Vesting period |
|
3 years
|
|
|
|
|
|
Conditional Share Capital Plan |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Common shares reserved for future issuance (in shares) |
|
|
2,833,459
|
|
2,833,459
|
|
8,000,000
|
Share-based compensation expense |
|
|
|
|
$ 2,357
|
|
|
Expense recognized |
|
|
$ 975
|
|
$ 2,038
|
|
|
Inducement Plan - Share Options |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Common shares reserved for future issuance (in shares) |
|
|
688,800
|
|
688,800
|
|
|
Share-based compensation expense |
|
|
|
|
$ 95
|
|
|
Expense recognized |
|
|
$ 95
|
|
95
|
|
|
Maximum shares available for grant (in shares) |
|
|
|
|
|
|
1,000,000
|
2022 ESPP |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Expense recognized |
|
|
$ 70
|
$ 108
|
$ 146
|
$ 205
|
|
2022 ESPP | Employee Stock |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Offering period |
6 months
|
|
|
|
|
|
|
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v3.24.2.u1
Share-based compensation - Schedule of Option Activity (Details) - $ / shares
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2024 |
Dec. 31, 2023 |
Weighted average strike price per share (in $ per share) |
|
|
Beginning balance (in dollars per share) |
$ 11.00
|
|
Granted (in dollars per share) |
3.83
|
|
Forfeited (in dollars per share) |
10.50
|
|
Expired (in dollars per share) |
32.53
|
|
Exercised (in dollars per share) |
2.62
|
|
Ending balance (in dollars per share) |
$ 9.23
|
$ 11.00
|
Number of awards |
|
|
Beginning balance (in shares) |
10,744,406
|
|
Granted (in shares) |
540,400
|
|
Forfeited (in shares) |
(428,200)
|
|
Expired (in shares) |
(866,595)
|
|
Exercised (in shares) |
(31,988)
|
|
Ending balance (in shares) |
9,958,023
|
10,744,406
|
Additional Disclosures |
|
|
Weighted average remaining life in years |
7 years 9 months 7 days
|
8 years 1 month 20 days
|
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v3.24.2.u1
Share-based compensation - Schedule of Stock Option Valuation Assumptions (Details) - $ / shares
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
Strike price (in dollars per share) |
|
|
$ 3.83
|
|
Employee Stock Option |
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
Expected volatility, in % |
95.00%
|
|
95.00%
|
|
Award life, in years |
6 years 29 days
|
6 years 29 days
|
6 years 29 days
|
6 years 29 days
|
Expected dividends |
0.00%
|
0.00%
|
0.00%
|
0.00%
|
Risk-free interest rate, in %, minimum |
4.24%
|
3.56%
|
3.75%
|
3.39%
|
Risk-free interest rate, in %, maximum |
4.54%
|
4.02%
|
4.54%
|
4.13%
|
Employee Stock Option | Minimum |
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
Share price (in dollars per share) |
$ 3.31
|
$ 1.96
|
$ 1.69
|
$ 1.96
|
Strike price (in dollars per share) |
3.31
|
$ 1.96
|
1.69
|
$ 1.96
|
Expected volatility, in % |
|
75.00%
|
|
75.00%
|
Employee Stock Option | Maximum |
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
Share price (in dollars per share) |
4.71
|
$ 2.38
|
4.86
|
$ 5.45
|
Strike price (in dollars per share) |
$ 4.71
|
$ 2.38
|
$ 4.86
|
$ 5.45
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v3.24.2.u1
Share-based compensation - Schedule of RSU Activity (Details) - Restricted Stock Units
|
6 Months Ended |
Jun. 30, 2024
$ / shares
shares
|
Number of awards |
|
Beginning balance (in shares) |
6,533,843
|
Granted (in shares) |
280,000
|
Vested (in shares) |
(502,929)
|
Forfeited (in shares) |
(521,038)
|
Ending balance (in shares) |
5,789,876
|
Weighted average grant date fair value |
|
Beginning balance (in dollars per share) | $ / shares |
$ 2.03
|
Granted (in dollars per share) | $ / shares |
3.16
|
Vested (in dollars per share) | $ / shares |
9.17
|
Forfeited (in dollars per share) | $ / shares |
1.88
|
Ending balance (in dollars per share) | $ / shares |
$ 1.48
|
Conditional Share Capital Plan - RSUs |
|
Number of awards |
|
Ending balance (in shares) |
5,166,541
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v3.24.2.u1
Loss per share - Schedule of Loss per Share (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Earnings Per Share [Abstract] |
|
|
|
|
Net loss |
$ (36,544)
|
$ (48,922)
|
$ (83,150)
|
$ (108,296)
|
Weighted average number of shares outstanding, diluted (in shares) |
95,691,245
|
81,471,127
|
89,121,783
|
81,140,287
|
Weighted average number of shares outstanding, basic (in shares) |
95,691,245
|
81,471,127
|
89,121,783
|
81,140,287
|
Net loss per share, diluted (in dollars per share) |
$ (0.38)
|
$ (0.60)
|
$ (0.93)
|
$ (1.33)
|
Net loss per share, basic (in dollars per share) |
$ (0.38)
|
$ (0.60)
|
$ (0.93)
|
$ (1.33)
|
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v3.24.2.u1
Loss per share - Schedule of Potentially Dilutive Securities Excluded from Earnings Per Share Calculation (Details) - shares
|
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Antidilutive securities (in shares) |
20,688,034
|
17,342,313
|
2019 Equity Incentive Plan | Employee Stock Option |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Antidilutive securities (in shares) |
9,269,223
|
11,293,279
|
2019 Equity Incentive Plan | Restricted Stock Units |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Antidilutive securities (in shares) |
623,335
|
1,108,899
|
Inducement Plan - Share Options |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Antidilutive securities (in shares) |
688,800
|
0
|
Conditional Share Capital Plan - RSUs |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Antidilutive securities (in shares) |
5,166,541
|
0
|
Outstanding warrants |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Antidilutive securities (in shares) |
4,940,135
|
4,940,135
|
X |
- DefinitionSecurities (including those issuable pursuant to contingent stock agreements) that could potentially dilute basic earnings per share (EPS) or earnings per unit (EPU) in the future that were not included in the computation of diluted EPS or EPU because to do so would increase EPS or EPU amounts or decrease loss per share or unit amounts for the period presented.
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