ADC Therapeutics SA 6-K, filed Aug 9, 2022
ADC Therapeutics SA (ADCT)
6-K
2022-08-09
For: 2022-06-30
View Original
Added on
April 07, 2026
About this 6-K
ADC Therapeutics SA filed this 6-K on August 9, 2022.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of August 2022
Commission File Number: 001-39071
(Exact name of registrant as specified in its charter)
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
| Form 20-F | ☒ | Form 40-F | ||||||||||||||||||
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
INCORPORATION BY REFERENCE
This Report on Form 6-K (other than Exhibit 99.3 hereto), including Exhibits 99.1 and 99.2 hereto, shall be deemed to be incorporated by reference into the registration statements on Form F-3 (Registration Nos. 333-256686 and 333-256807) of ADC Therapeutics SA and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
SIGNATURE
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 | ||||||||
| By: | /s/ Jennifer Creel | |||||||
| Name: | Jennifer Creel | |||||||
| Title: | Chief Financial Officer | |||||||
| Date: August 9, 2022 | ||||||||
EXHIBIT INDEX
| Exhibit Number | Description | ||||
| 99.1 | |||||
| 99.2 | |||||
| 99.3 | |||||
| 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 (formatted as Inline XBRL and contained in Exhibit 101) | ||||
Exhibit 99.1
Unaudited IFRS Condensed Consolidated Interim Financial Statements as of and for the three and six months ended June 30, 2022.
Condensed Consolidated Interim Balance Sheet | |||||
1
ADC Therapeutics SA
Condensed Consolidated Interim Statement of Operations
(in KUSD except for per share data)
| For the Three Months Ended June 30, | For the Six Months Ended June 30, | |||||||||||||||||||||||||||||||
| Note | 2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||||||||||
| Product revenues, net | 5 | |||||||||||||||||||||||||||||||
| License revenue | 3, 5 | |||||||||||||||||||||||||||||||
| Total revenue | ||||||||||||||||||||||||||||||||
| Operating expense | ||||||||||||||||||||||||||||||||
| Cost of product sales | 7 | ( | ( | ( | ( | |||||||||||||||||||||||||||
| Research and development expenses | 7 | ( | ( | ( | ( | |||||||||||||||||||||||||||
| Selling and marketing expenses | 7 | ( | ( | ( | ( | |||||||||||||||||||||||||||
| General and administrative expenses | 7 | ( | ( | ( | ( | |||||||||||||||||||||||||||
| Total operating expense | ( | ( | ( | ( | ||||||||||||||||||||||||||||
| Loss from operations | ( | ( | ( | ( | ||||||||||||||||||||||||||||
| Other income (expense) | ||||||||||||||||||||||||||||||||
| Financial income | 16 | |||||||||||||||||||||||||||||||
| Financial expense | 13, 14, 16 | ( | ( | ( | ( | |||||||||||||||||||||||||||
| Non-operating income | 8 | |||||||||||||||||||||||||||||||
| Total other income (expense) | ( | |||||||||||||||||||||||||||||||
| Loss before taxes | ( | ( | ( | ( | ||||||||||||||||||||||||||||
| Income tax benefit (expense) | ( | ( | ||||||||||||||||||||||||||||||
| Net loss | ( | ( | ( | ( | ||||||||||||||||||||||||||||
| Net loss attributable to: | ||||||||||||||||||||||||||||||||
| Owners of the parent | ( | ( | ( | ( | ||||||||||||||||||||||||||||
| Net loss per share, basic and diluted | 18 | ( | ( | ( | ( | |||||||||||||||||||||||||||
The accompanying notes form an integral part of these condensed consolidated interim financial statements (Unaudited)
2
ADC Therapeutics SA
Condensed Consolidated Interim Statement of Comprehensive Loss
(in KUSD)
| For the Three Months Ended June 30, | For the Six Months Ended June 30, | |||||||||||||||||||||||||||||||
| Note | 2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||||||||||
| Net Loss | ( | ( | ( | ( | ||||||||||||||||||||||||||||
| Other comprehensive (loss) income | ||||||||||||||||||||||||||||||||
| Items that will not be reclassified to profit and loss | ||||||||||||||||||||||||||||||||
| Remeasurement of defined benefit pension liability | 2 | |||||||||||||||||||||||||||||||
| Total items that will not be reclassified to profit and loss | ||||||||||||||||||||||||||||||||
| Items that may be reclassified to profit and loss | ||||||||||||||||||||||||||||||||
| Currency translation differences | ( | ( | ||||||||||||||||||||||||||||||
| Total items that may be reclassified to profit and loss | ( | ( | ||||||||||||||||||||||||||||||
| Other comprehensive income for the period | ||||||||||||||||||||||||||||||||
| Total comprehensive loss for the period | ( | ( | ( | ( | ||||||||||||||||||||||||||||
| Total comprehensive loss attributable to: | ||||||||||||||||||||||||||||||||
| Owners of the parent | ( | ( | ( | ( | ||||||||||||||||||||||||||||
The accompanying notes form an integral part of these condensed consolidated interim financial statements (Unaudited)
3
ADC Therapeutics SA
Condensed Consolidated Interim Balance Sheet
(in KUSD)
| Note | June 30, 2022 | December 31, 2021 | ||||||||||||||||||||||||||||||
| ASSETS | ||||||||||||||||||||||||||||||||
| Current assets | ||||||||||||||||||||||||||||||||
| Cash and cash equivalents | 9 | |||||||||||||||||||||||||||||||
| Accounts receivable, net | ||||||||||||||||||||||||||||||||
| Inventory | 10 | |||||||||||||||||||||||||||||||
| Other current assets | ||||||||||||||||||||||||||||||||
| Total current assets | ||||||||||||||||||||||||||||||||
| Non-current assets | ||||||||||||||||||||||||||||||||
| Property, plant and equipment | ||||||||||||||||||||||||||||||||
| Right-of-use assets | 13 | |||||||||||||||||||||||||||||||
| Intangible assets | 11 | |||||||||||||||||||||||||||||||
| Interest in joint venture | 12 | |||||||||||||||||||||||||||||||
| Deferred tax asset | ||||||||||||||||||||||||||||||||
| Other long-term assets | ||||||||||||||||||||||||||||||||
| Total non-current assets | ||||||||||||||||||||||||||||||||
| Total assets | ||||||||||||||||||||||||||||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||||||||||||||||||||||||||
| Current liabilities | ||||||||||||||||||||||||||||||||
| Accounts payable | ||||||||||||||||||||||||||||||||
| Other current liabilities | ||||||||||||||||||||||||||||||||
| Lease liabilities, short-term | 13 | |||||||||||||||||||||||||||||||
| Current income tax payable | ||||||||||||||||||||||||||||||||
| Convertible loans, short-term | 14 | |||||||||||||||||||||||||||||||
| Total current liabilities | ||||||||||||||||||||||||||||||||
| Non-current liabilities | ||||||||||||||||||||||||||||||||
| Convertible loans, long-term | 14 | |||||||||||||||||||||||||||||||
| Convertible loans, derivatives | 14 | |||||||||||||||||||||||||||||||
| Deferred royalty obligation, long-term | 16 | |||||||||||||||||||||||||||||||
| Deferred gain of joint venture | 12 | |||||||||||||||||||||||||||||||
| Lease liabilities, long-term | 13 | |||||||||||||||||||||||||||||||
| Defined benefit pension liabilities | 2 | |||||||||||||||||||||||||||||||
| Total non-current liabilities | ||||||||||||||||||||||||||||||||
| Total liabilities | ||||||||||||||||||||||||||||||||
| Equity attributable to owners of the parent | ||||||||||||||||||||||||||||||||
| Share capital | ||||||||||||||||||||||||||||||||
| Share premium | ||||||||||||||||||||||||||||||||
| Treasury shares | ( | ( | ||||||||||||||||||||||||||||||
| Other reserves | 2, 15 | |||||||||||||||||||||||||||||||
| Cumulative translation adjustments | ( | |||||||||||||||||||||||||||||||
| Accumulated losses | ( | ( | ||||||||||||||||||||||||||||||
| Total equity attributable to owners of the parent | ||||||||||||||||||||||||||||||||
| Total liabilities and equity | ||||||||||||||||||||||||||||||||
The accompanying notes form an integral part of these condensed consolidated interim financial statements (Unaudited)
4
ADC Therapeutics SA
Condensed Consolidated Interim Statement of Changes in Equity
(in KUSD)
For the Three and Six Months Ended June 30, 2022
| Note | Share Capital | Share Premium | Other Reserves | Treasury Shares | Cumulative Translation Adjustments | Accumulated Losses | Total Equity | ||||||||||||||||||||||||||||||||||||||||
| April 1, 2022 | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||
| Loss for the period | — | — | — | — | — | ( | ( | ||||||||||||||||||||||||||||||||||||||||
| Remeasurement of defined benefit pension liability | 2 | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
| Translation adjustment | — | — | — | — | ( | — | ( | ||||||||||||||||||||||||||||||||||||||||
| Total other comprehensive income (loss) | — | — | — | ( | — | ||||||||||||||||||||||||||||||||||||||||||
| Total comprehensive income (loss) for the period | — | — | — | ( | ( | ( | |||||||||||||||||||||||||||||||||||||||||
| Share-based compensation expense | 15 | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
| Total transactions with owners | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||
| June 30, 2022 | ( | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||
| Note | Share Capital | Share Premium | Other Reserves | Treasury Shares | Cumulative Translation Adjustments | Accumulated Losses | Total Equity | ||||||||||||||||||||||||||||||||||||||||
| January 1, 2022 | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||
| Loss for the period | — | — | — | — | — | ( | ( | ||||||||||||||||||||||||||||||||||||||||
| Remeasurement of defined benefit pension liability | 2 | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
| Translation adjustment | — | — | — | — | ( | — | ( | ||||||||||||||||||||||||||||||||||||||||
| Total other comprehensive income (loss) | — | — | — | ( | — | ||||||||||||||||||||||||||||||||||||||||||
| Total comprehensive income (loss) for the period | — | — | — | ( | ( | ( | |||||||||||||||||||||||||||||||||||||||||
| Exercise of options and vestings of RSUs | — | ( | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
| Share-based compensation expense | 15 | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
| Total transactions with owners | ( | — | — | ||||||||||||||||||||||||||||||||||||||||||||
| June 30, 2022 | ( | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||
5
ADC Therapeutics SA
Condensed Consolidated Interim Statement of Changes in Equity
(in KUSD)
For the Three and Six Months Ended June 30, 2021
| Note | Share Capital | Share Premium | Other Reserves | Treasury Shares | Cumulative Translation Adjustments | Accumulated Losses | Total Equity | ||||||||||||||||||||||||||||||||||||||||
| April 1, 2021 | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||
| Loss for the period | — | — | — | — | — | ( | ( | ||||||||||||||||||||||||||||||||||||||||
| Translation adjustment | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
| Total other comprehensive income | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
| Total comprehensive income (loss) for the period | — | — | — | — | ( | ( | |||||||||||||||||||||||||||||||||||||||||
| Issuance of shares to be held as treasury shares | — | — | ( | — | — | ||||||||||||||||||||||||||||||||||||||||||
| Exercise of options | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||
| Share-based compensation expense | 15 | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
| Total transactions with owners | ( | — | — | ||||||||||||||||||||||||||||||||||||||||||||
| June 30, 2021 | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||
| Note | Share Capital | Share Premium | Other Reserves | Treasury Shares | Cumulative Translation Adjustments | Accumulated Losses | Total Equity | ||||||||||||||||||||||||||||||||||||||||
| January 1, 2021 | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||
| Loss for the period | — | — | — | — | — | ( | ( | ||||||||||||||||||||||||||||||||||||||||
| Translation adjustment | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
| Total other comprehensive income | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
| Total comprehensive income (loss) for the period | — | — | — | — | ( | ( | |||||||||||||||||||||||||||||||||||||||||
| Issuance of shares to be held as treasury shares | — | — | ( | — | — | ||||||||||||||||||||||||||||||||||||||||||
| Exercise of options | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||
| Share-based compensation expense | 15 | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
| Total transactions with owners | ( | — | — | ||||||||||||||||||||||||||||||||||||||||||||
| June 30, 2021 | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||
The accompanying notes form an integral part of these condensed consolidated interim financial statements (Unaudited)
6
ADC Therapeutics SA
Condensed Consolidated Interim Statement of Cash Flows (in KUSD)
| For the Six Months Ended June 30, | |||||||||||||||||
| Note | 2022 | 2021 | |||||||||||||||
| Cash used in operating activities | |||||||||||||||||
| Loss for the period | ( | ( | |||||||||||||||
| Adjustments for non-monetary items: | |||||||||||||||||
| Share-based compensation expense | 15 | ||||||||||||||||
| Impairments of Assets | 7 | ||||||||||||||||
| Depreciation of property, plant and equipment | |||||||||||||||||
| Amortization of intangible assets | 11 | ||||||||||||||||
| Depreciation of right-of-use assets | 13 | ||||||||||||||||
| Gain from reversal of inventory impairment charges | 10 | ( | |||||||||||||||
| Share of results in joint venture | 8, 12 | ||||||||||||||||
| Deferred income taxes | ( | ||||||||||||||||
| Change in defined benefit pension liability | |||||||||||||||||
| Convertible loans, derivatives, decrease in fair value | 8, 14 | ( | ( | ||||||||||||||
| Financial income | 16 | ( | ( | ||||||||||||||
| Financial expense | 14, 16 | ||||||||||||||||
| Exchange differences | ( | ( | |||||||||||||||
| Operating loss before working capital changes | ( | ( | |||||||||||||||
| Decrease (increase) in accounts receivable, net | ( | ||||||||||||||||
| Increase in inventory | ( | ( | |||||||||||||||
| Decrease (increase) in other current assets | ( | ||||||||||||||||
| Increase in accounts payable | |||||||||||||||||
| Increase in income taxes | |||||||||||||||||
| Decrease in other liabilities and other payables | ( | ( | |||||||||||||||
| Cash used in operating activities | ( | ( | |||||||||||||||
| Interest paid | ( | ( | |||||||||||||||
| Interest received | |||||||||||||||||
| Interest expense on lease obligations | 13 | ||||||||||||||||
| Interest paid under royalty financing transaction | 16 | ( | |||||||||||||||
| Taxes paid | ( | ( | |||||||||||||||
| Net cash used in operating activities | ( | ( | |||||||||||||||
| Cash used in investing activities | |||||||||||||||||
| Payment for purchase of property, plant and equipment | ( | ( | |||||||||||||||
| Payment for purchase of intangible assets | 11 | ( | ( | ||||||||||||||
| Payment for deposits | ( | ||||||||||||||||
| Net cash used in investing activities | ( | ( | |||||||||||||||
| Cash (used in) provided by financing activities | |||||||||||||||||
| Proceeds from convertible loans, net of transaction costs | 14 | ||||||||||||||||
| Proceeds from the exercise of stock options | |||||||||||||||||
| Principal portion of lease obligation payments | 13 | ( | ( | ||||||||||||||
| Net cash (used in) provided by financing activities | ( | ||||||||||||||||
| Net decrease in cash and cash equivalents | ( | ( | |||||||||||||||
| Exchange (losses) / gain on cash and cash equivalents | ( | ||||||||||||||||
| Cash and cash equivalents at beginning of the period | |||||||||||||||||
| Cash and cash equivalents at end of the period | |||||||||||||||||
| Supplemental Non-Cash Investing Information | |||||||||||||||||
| Capital expenditures recorded in Accounts payable | |||||||||||||||||
The accompanying notes form an integral part of these condensed consolidated interim financial statements (Unaudited)
7
ADC Therapeutics SA | ||
Notes to the Condensed Consolidated Interim Financial Statements (Unaudited) – in KUSD except for share and per share data
1.Corporate information
ADC Therapeutics SA (the “Company” or “ADCT”) was incorporated on June 6, 2011 under the laws of Switzerland. The registered office of the Company is located at Route de la Corniche 3B, 1066 Epalinges, Switzerland. The Company controls 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”).
The Group is focused on the development of antibody drug conjugates (“ADCs”), including research, development, human clinical trials, regulatory approval and commercialization. On April 23, 2021, the U.S. Food and Drug Administration (“FDA”) approved ZYNLONTA for the treatment of relapsed or refractory diffuse large B-cell lymphoma (“DLBCL”) and the Company commenced recognizing revenue upon the sale of ZYNLONTA during the second quarter of 2021. ADCs are drug constructs which combine monoclonal antibodies specific to particular types of cells with cytotoxic molecules or warheads which seek to kill any cancer cell to which the ADC attaches. ADCs have extensive potential therapeutic applications in cancer.
These unaudited condensed consolidated interim financial statements were authorized for issue by the Board of Directors on August 9, 2022.
Going concern basis
ADCT is a commercial-stage company developing innovative therapeutics. The Group is exposed to all risks inherent in establishing and developing its business, including the substantial uncertainty that current projects will succeed. The Group’s success may also depend on its ability to:
•establish and maintain a strong patent position and protection;
•develop, gain regulatory approval and commercialize drug products;
•enter into collaborations with partners in the pharmaceutical industry;
•acquire and retain key personnel; and
•acquire additional funding to support its operations.
Since its incorporation, the Group has primarily funded its growth through capital increases and additional funds provided by research collaborations, license agreements, the issuance of the Company’s common shares, the issuance of convertible loans, and proceeds from a royalty purchase agreement (see notes 14, “Convertible loans” and 16, “Deferred royalty obligation”). During the first quarter of 2022 and third quarter of 2022, the Company entered into exclusive license agreements with Mitsubishi Tanabe Pharma Corporation ("MTPC") and Swedish Orphan Biovitrum AB ("Sobi"), respectively, for the development and commercialization of ZYNLONTA for all hematologic and solid tumor indications in Japan and all territories outside the U.S., greater China, Singapore and Japan, respectively. The Group does not have recourse to bank loans. As a result, the Group is not exposed to liquidity risk through requests for early repayment of loans, other than, pursuant to the convertible loans, it must maintain a balance of at least USD 50 million in cash and cash equivalents at the end of each quarter.
As of June 30, 2022, the Group’s cash and cash equivalents amounted to USD 376.8 million (December 31, 2021: USD 466.5 million).
Management believes that the Group has sufficient financial resources to cover its operating costs for at least the next 12 months from the date of issuance of these unaudited condensed consolidated interim financial statements and, as a result, is presenting these unaudited condensed consolidated interim financial statements of the Group on a going concern basis.
8
COVID – 19
The Group continues to monitor the COVID-19 pandemic and its impact to operations. The Group is commercializing ZYNLONTA using hybrid launch plans. Recently, the Company has seen an increase in face-to-face interactions with physicians, which it believes is a key pillar of its continued success in driving the adoption of ZYNLONTA through ongoing dialogs with the healthcare provider community on ZYNLONTA's differentiated product profile. The Group is in close contact with its principal investigators and clinical sites, which are located in jurisdictions affected by the COVID-19 pandemic and is assessing the impact of the COVID-19 pandemic on its clinical trials, expected timelines and costs on an ongoing basis. In response to the spread of COVID-19, the Group has also modified its business practices based on local guidelines. At this time, Group employees are meeting with investigators and site staff in person as allowed by institutions. The Group continues to closely monitor the potential effects of the COVID-19 pandemic on its clinical trials, commercialization efforts and supply chain, and will work closely with its clinical trial sites and principal investigators, contract research organizations, customers and distributors and contract manufacturing partners to mitigate such impact. As the COVID-19 pandemic continues to evolve, the Group believes the impact to its operations, operating results, cash flows, liquidity and financial condition will be primarily driven by the severity and duration, the impact on the U.S. and global economies, the timing, the availability, and acceptance and effectiveness of vaccines and treatments, particularly against emerging variants of the novel coronavirus, and the scope and effectiveness of national and local governmental responses to the pandemic. Those primary drivers are beyond the Group’s knowledge and control, and as a result, the ultimate impact of the COVID-19 pandemic on the Group's results of operations, cash flows and financial position for the remainder of 2022 and thereafter cannot be reasonably predicted. However, on the basis of the risk mitigation measures undertaken, the Group has concluded that there is no material uncertainty that may cast a significant doubt upon the Group’s ability to continue as a going concern.
2.Basis of preparation
Statement of Compliance
These unaudited condensed consolidated interim financial statements as of and for the three and six months ended June 30, 2022 have been prepared in accordance with International Accounting Standard 34 Interim Financial Reporting (“IAS 34”) and should be read in conjunction with the audited consolidated financial statements as of and for the year ended December 31, 2021.
Functional and reporting currency
These unaudited condensed consolidated interim financial statements are presented in United States Dollars (“USD” or “$”), which is the Company’s functional currency and the Group’s reporting currency.
A subsidiary of the Company, ADCT UK, has a functional currency of the British Pound (“GBP”). The following exchange rates have been used for the translation of the financial statements of ADCT UK:
| Six Months Ended June 30, | |||||||||||
| 2022 | 2021 | ||||||||||
| USD / GBP | |||||||||||
| Closing rate, GBP 1 | |||||||||||
| Weighted average exchange rate, GBP 1 | |||||||||||
9
Basis of Consolidation
The unaudited condensed consolidated interim financial statements incorporate the financial statements of the Company and entities controlled by the Company which are the same as those contained in the audited consolidated financial statements as of and for the year ended December 31, 2021.
Use of estimates and judgements
The preparation of the unaudited condensed consolidated interim financial statements in conformity with IAS 34 requires management to make judgements, estimates and assumptions that affect the application of accounting policies and the reported amounts of assets and liabilities, income and expense. Actual results may differ from these estimates.
Estimates are based on management’s knowledge of current events and actions that the Company may undertake in the future. Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimate is revised if the revision affects only that period, or in the period of the revision and future periods if the revision affects both current and future periods.
As a result of increases in interest rates, the Company assessed the impact of utilizing a higher discount rate, 2.0 %, in its most recent pension obligation actuarial valuation performed as of December 31, 2021. The use of a higher discount rate resulted in a decrease of KUSD 3.6 million to its Defined benefit pension liabilities with a corresponding offset to Other comprehensive loss. The reduction in its Defined benefit pension liability was capped at the fair value of the Company’s pension plan assets. The Company expects to perform its annual actuarial valuation in conjunction with its fiscal year ending December 31, 2022.
Other income (expense)
For periods prior to December 31, 2021, individual components of Non-operating income (expense) were reported separately within the statement of operations. Prior periods have been recast to conform to the current period presentation. See Note 8, “Non-operating income (expense)” for further information.
3.Significant accounting policies
The accounting policies applied by the Company in these unaudited condensed consolidated interim financial statements are the same as those applied by the Company in its audited consolidated financial statements as of and for the year ended December 31, 2021 and have been applied consistently to all periods presented in these unaudited condensed consolidated interim financial statements, except for the following:
Revenue Recognition
License Arrangements
On January 18, 2022, the Company entered into an exclusive license agreement with MTPC for the development and commercialization of ZYNLONTA for all hematologic and solid tumor indications in Japan. In previous years, the Company had generated revenue from the sale of its product candidates and service revenues from a license and collaboration arrangement. See note 5 “License Revenue” for further information on the MTPC arrangement.
The Company recognizes revenues from license fees for intellectual property (IP) either at a point in time or over time. The Company must make an assessment as to whether such a license represents a right-to-use the IP (at a point in time) or a right to access the IP (over time). The Company recognizes revenue for a right-to-use license immediately if the licensee can begin to use and benefit from the IP upon commencement of the license term and the Company has no further obligations in the context of the IP. A license is considered a right to access the IP when the Company undertakes activities during the license term that may significantly affect the IP, which directly exposes the customer to any positive or negative
10
effects arising from such activities. These activities do not result in the immediate transfer of a good or service to the customer. As such, revenues from the right to access the IP are recognized over time.
The Company may enter into agreements with multiple performance obligations. Performance obligations are identified and separated when the other party can benefit from the license on its own or together with other resources that are readily available, and the license is separately identifiable from other goods or services in the contract.
Transaction prices for out-license arrangements may include fixed up-front amounts as well as variable consideration such as contingent development and regulatory milestones, sales-based milestones and royalties. The most likely amount method is used to estimate contingent development and regulatory milestones because the ultimate outcomes are binary in nature. Variable consideration is included in the transaction price only to the extent that it is highly probable that a significant reversal in the amount of cumulative revenue will not occur when the uncertainty associated with the variable consideration is subsequently resolved. To the extent arrangements include multiple performance obligations that are separable, the transaction price assigned to each distinct performance obligation is reflective of the relative stand-alone selling price when sold separately or estimated stand-alone selling price on the basis of comparable transactions with other customers when such goods or services are not sold separately. The residual approach is the method used to estimate a stand-alone selling price when the selling price for a good or service is highly variable or uncertain.
In determining the transaction prices, sales milestones and royalties attributable to licenses are excluded from the variable consideration guidance and recognized at the later of when the subsequent sales transaction occurs, or the satisfaction or partial satisfaction of the performance obligation to which some or all of the royalty has been allocated.
There are no new IFRS standards, amendments to standards or interpretations that are mandatory for the financial year beginning on January 1, 2022, that are relevant to the Group and that have had any impact in the interim period. New standards, amendments to standards and interpretations that are not yet effective, which have been deemed by the Group as currently not relevant, are not listed here.
4.Financial risk management
4.1Financial risk factors
The Group’s activities are exposed to a variety of financial risks: market risk (including changes in the Company’s share price, exposure to fluctuation in currency exchange rates and exposure to interest rate movements), credit risk and liquidity risk.
The unaudited condensed consolidated interim financial statements do not include all financial risk management information and disclosures required in the annual financial statements, and should be read in conjunction with the Group’s consolidated financial statements as of December 31, 2021. In relation to the royalty purchase agreement with entities managed by Healthcare Royalty Management, LLC ("HCR"), the Company is obligated to pay interest in the form of royalties in connection with certain net sales and licensing revenue. As the effective interest rate on the deferred royalty obligation does not depend on market performance, the exposure to interest rate and market risk is deemed low. See note 16, “Deferred royalty obligations” for further information. There have been no material changes in financial risk management since year-end.
4.2Fair value estimation
At June 30, 2022, the carrying amount is a reasonable approximation of fair value for the following financial assets and liabilities:
•Cash and cash equivalents
•Trade accounts receivable
•Trade accounts payable
In the six months ended June 30, 2022, there were no significant changes in the business or economic circumstances that affected the fair value of the Group’s financial assets and financial liabilities.
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Fair values must be estimated at each grant date with regard to awards under the ADC Therapeutics SA 2019 Equity Incentive Plan (the “Equity Incentive Plan 2019”) and with regard to the convertible loan conversion option derivative related to the first tranche and second tranche of the convertible loans. The approach to valuation follows the grant date fair value principle, and the key input factors are described for the share-based compensation awards in note 15, “Share-based compensation” and for the convertible loan derivatives in note 14, “Convertible loans”. Commonly accepted pricing models (Hull and Goldman Sachs) have been used to calculate the fair value of the convertible loan derivatives. The valuation of the embedded derivative in the first tranche and second tranche are classified as pertaining to level 3 of the valuation hierarchy set out below.
The different levels of the valuation hierarchy have been defined as follows:
(a)Level 1: quoted prices (unadjusted) in active markets for identical assets or liabilities;
(b)Level 2: inputs other than quoted prices that are observable for the asset or liability, either directly (for example, as prices) or indirectly (for example, derived from prices);
(c)Level 3: inputs for the asset or liability that are not based on observable market data.
There were no transfers between the respective levels during the period.
The embedded derivative conversion feature associated with the first and second tranche of the Company’s convertible loans (see note 14, “Convertible loans”) are re-measured to fair value at each reporting date. The Company utilizes a risk free rate, an implied bond yield and a selected volatility in determining the fair value of its embedded derivatives.
A hypothetical 10 % increase (decrease) in the risk-free rate as of June 30, 2022 would have increased (decreased) the derivative value associated with the first tranche of our convertible loans by KUSD 30 and (KUSD 29 ). A hypothetical 10 % increase (decrease) in the implied bond yield as of June 30, 2022 would have increased (decreased) the derivative value associated with the first tranche of our convertible loans by KUSD 79 and (KUSD 18 ). A hypothetical 10 % increase (decrease) in the selected volatility as of June 30, 2022 would have increased (decreased) the derivative value associated with the first tranche of our convertible loans by KUSD 1,254 and (KUSD 1,105 ).
A hypothetical 10 % increase (decrease) in the risk-free rate as of June 30, 2022 would have decreased the derivative value associated with the second tranche of our convertible loans by KUSD 18 and KUSD 22 . A hypothetical 10 % increase (decrease) in the implied bond yield as of June 30, 2022 would have decreased the derivative value associated with the second tranche of our convertible loans by KUSD 8 and KUSD 36 . A hypothetical 10 % increase (decrease) in the selected volatility as of June 30, 2022 would have increased (decreased) the derivative value associated with the second tranche of our convertible loans by KUSD 671 and (KUSD 803 ).
5.Revenue recognition
Product revenue
On April 23, 2021, the Company received FDA accelerated regulatory and marketing approval for ZYNLONTA and launched in the U.S. shortly thereafter. To date, the Company’s only source of product revenue, which commenced during May 2021, has been sales of ZYNLONTA only in the U.S. Product revenues, net were KUSD 17,291 and KUSD 33,789 for the three and six months ended June 30, 2022, respectively. Product revenues, net were KUSD 3,760 for both the three and six months ended June 30, 2021. The Company records its best estimate of gross-to-net ("GTN") sales adjustments to which customers are likely to be entitled.
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| Three months ended June 30, | Six months ended June 30, | |||||||||||||||||||||||||
| (in KUSD) | 2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||||
| Beginning balance | ||||||||||||||||||||||||||
| GTN sales adjustments for current year sales | ||||||||||||||||||||||||||
| GTN sales adjustments for prior year sales | ( | |||||||||||||||||||||||||
| Credits, payments and reclassifications to Accounts payable | ( | ( | ( | ( | ||||||||||||||||||||||
| Ending balance as of June 30, | ||||||||||||||||||||||||||
The table below provides the classification of the accruals related to the GTN sales adjustment included in the Company’s unaudited condensed consolidated interim balance sheet as of June 30, 2022 and December 31, 2021.
| (in KUSD) | As of June 30, 2022 | As of December 31, 2021 | ||||||||||||
| Accounts receivable, net | ||||||||||||||
| Other current liabilities | ||||||||||||||
Accounts receivable
As the Company’s inventory is no longer held on consignment by the Company’s third-party logistics and distribution provider and as a result of receiving a permanent J-code for ZYNLONTA, the Company’s payment terms currently range from 30 days to 90 days.
License revenue
On January 18, 2022, the Company entered into an exclusive license agreement with MTPC for the development and commercialization of ZYNLONTA for all hematologic and solid tumor indications in Japan. Under the terms of the agreement, the Company received an upfront payment of USD 30 million and may receive up to an additional USD 205 million in milestones if certain development and commercial events are achieved. The Company will also be entitled to receive royalties ranging in percentage from the high teens to the low twenties based on net sales of ZYNLONTA in Japan. MTPC will conduct clinical studies of ZYNLONTA in Japan and will have the right to participate in any global clinical studies by bearing a portion of the study costs. In addition, the Company will supply ZYNLONTA to MTPC for its drug development and commercialization under a supply agreement.
The MTPC license arrangement includes a license and a performance obligation to supply product. The license and supply obligations are accounted for as separate performance obligations as they are considered distinct because MTPC can benefit from the license on its own or together with other resources that are readily available, and the license is separately identifiable from other goods or services in the contract.
The Company completed significant development work which resulted in FDA approval of ZYNLONTA in the U.S. for the treatment of relapsed or refractory DLBCL. As a result, the up-front license fee is recognized immediately at the time of license execution, as MTPC can use and benefit from the IP and the Company has no further performance obligation with respect to the IP upon commencement of the license term.
Although contingent development milestone amounts are assessed each period for the likelihood of achievement, they are typically constrained and recognized when the uncertainty is subsequently resolved for the full amount of the milestone and will be classified as license revenue. Sales milestones and royalties are recognized when the subsequent sales occur and classified as license revenue.
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6.Segment information
14
7.Operating expense
The following table provides the unaudited condensed consolidated interim statement of operation classification of our total operating expense:
| (in KUSD) | Three months ended June 30, | Six months ended June 30, | |||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
Cost of product sales | |||||||||||||||||||||||
| R&D | |||||||||||||||||||||||
External costs (1) | |||||||||||||||||||||||
Employee expense (2) | |||||||||||||||||||||||
| R&D expenses | |||||||||||||||||||||||
| S&M | |||||||||||||||||||||||
External costs (3) | |||||||||||||||||||||||
Employee expense (2) | |||||||||||||||||||||||
| S&M expenses | |||||||||||||||||||||||
| G&A | |||||||||||||||||||||||
External costs (1) | |||||||||||||||||||||||
Employee expense (2) | |||||||||||||||||||||||
| G&A expenses | |||||||||||||||||||||||
| Total operating expense | |||||||||||||||||||||||
(1) Includes depreciation expense
(2) Includes share-based compensation expense
(3) Includes depreciation expense for Property, plant and equipment for the three and six months ended June 30, 2022. All other depreciation expense was not material for the three and six months ended June 30, 2022. All depreciation expense was not material for the three and six months ended June 30, 2021.
The increase in Cost of product sales in the three and six months ended June 30, 2022, was primarily associated with USD 1.7 million of impairment charges related to the manufacturing of antibodies that was not within the company's specifications. In addition, Cost of product sales increased due to a full half-year of sales activity in 2022 as compared to the same periods in 2021 due to the commencement of ZYNLONTA sales in May 2021.
As a result of FDA approval of ZYNLONTA in April 2021, the Company reversed KUSD 6,752 of previously recorded impairment charges during the three and six months ended 2021, relating to inventory costs incurred for the manufacture of product prior to FDA approval. External costs increased primarily as a result of higher chemistry, manufacturing and controls ("CMC") expense due to manufacturing activities to support the ADCT-212 program during the three and six months ended June 30, 2022 as well as our continued clinical trials to expand the potential market opportunities for ZYNLONTA in earlier lines of therapy and new histologies, advance Cami to support a BLA submission and build our pipeline. Employee expense increased primarily due to higher employee headcount.
The increase in S&M expenses in the three and six months ended June 30, 2022 was primarily due to increased professional expenses relating to the commercial launch of ZYNLONTA. Employee expense decreased due to lower share-based compensation expense.
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8.Non-operating income (expense)
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||||||||||||||||||
| (in KUSD) | Note | 2022 | 2021 | 2022 | 2021 | |||||||||||||||||||||||||||
| Convertible loans, derivatives, change in fair value income | 14 | |||||||||||||||||||||||||||||||
| Convertible loans, derivatives, transaction costs | — | (148) | — | (148) | ||||||||||||||||||||||||||||
| Share of results with joint venture | 12 | ( | ( | ( | ( | |||||||||||||||||||||||||||
| Exchange differences gain (loss) | ( | |||||||||||||||||||||||||||||||
| R&D tax credit | ||||||||||||||||||||||||||||||||
| Non-operating income | ||||||||||||||||||||||||||||||||
Convertible loans, derivatives, change in fair value income (expense)
Changes in derivative fair values are explained in note 14, “Convertible loans”. Pursuant to the Facility Agreement with Deerfield, the Company drew down the first tranche of the convertible loans amounting to USD 65 million on May 19, 2020. Additionally, in connection with the FDA approval of ZYNLONTA, the Company drew down the second tranche of convertible loans amounting to USD 50 million.
Convertible loans, derivatives, transaction costs
The transaction costs of the embedded derivatives associated with the draw-down of the second tranche of the convertible loans on April 23, 2021 were charged directly to the unaudited condensed consolidated interim statement of operations. No such transaction costs were charged in fiscal year 2022.
Share of results with joint venture
In connection with the formation of Overland ADCT BioPharma in December 2020, the Company recorded its proportionate share of Overland ADCT BioPharma’s net loss. See note 12, “Interest in joint venture”.
Exchange differences
Also included in non-operating income (expense) are favorable or unfavorable Exchange differences. The Company is exposed to foreign exchange risk arising from various currency exposures, primarily with respect to British pounds, Euros and Swiss francs. Exchange differences represent gain or (loss) based on favorable or unfavorable changes in foreign currencies.
R&D tax credit
The Company recognizes as income (expense) amounts received and receivable by its subsidiary, ADCT UK, under the United Kingdom’s R&D Expenditure Credit scheme (“UK R&D Credit Scheme”). The grants represent 12% of eligible expenditure. The claims are payable through the tax system, as a refund of corporation tax or of other taxes, including income tax and social security payments deducted at source from qualifying (research) employees’ payroll and VAT. The relevant amounts have been therefore presented net in the balance sheet. As the credit is independent of ADCT UK’s taxable profit, is clearly designed to incentivize companies to invest in R&D activities and is itself taxable income, the Group has recognized the income as government grants within non-operating income (expense) and not as a credit to income tax expense.
16
9.Cash and cash equivalents
10.Inventory
Inventory as of June 30, 2022 and December 31, 2021 consisted of the following:
| (in KUSD) | As of June 30, 2022 | As of December 31, 2021 | ||||||||||||
| Work in process | ||||||||||||||
Finished goods (1) | ||||||||||||||
| Total inventory | ||||||||||||||
11.Intangible assets
Licenses classified as definite-lived intangible assets are amortized over their useful lives, which are determined on the basis of the expected pattern of consumption of the expected future economic benefits embodied in the licenses and which therefore commence only once the necessary regulatory and marketing approval has been received for the product candidates to which they relate. The Company classifies its licenses relating to product candidates for which regulatory approval has not been received as indefinite-lived intangible assets and did not recognize amortization expense relating to these licenses.
Internal development costs are classified as indefinite-lived intangible assets and are expected to be capitalized if they meet the criteria for recognition of an internally generated intangible asset, usually when marketing approval has been achieved from a regulatory authority in a major market. The Company began to capitalize internal development costs for
17
ZYNLONTA as an internally generated intangible asset upon the FDA approval in the U.S. and if certain recognition criteria were met.
During the six months ended June 30, 2022, the Company capitalized the following license fees paid or accrued to third parties as intangible assets:
Milestone Payments
•An amount of KUSD 500 paid upon the dosing of a specific number of patients in the first in-human clinical study related to an antibody the Company acquired from a third party to be used in research, development, manufacturing and commercialization. The amount was capitalized as an indefinite-lived intangible asset; and
•An amount of KUSD 195 paid upon the successful completion of in-vivo efficacy studies related to a license with a third party to use their specific binding proteins in the development, manufacturing and commercialization of products. The amount was capitalized as an indefinite-lived intangible asset.
During the six months ended June 30, 2021, the Company capitalized the following as intangible assets:
Milestone Payments
• An amount of KUSD 1,050 paid upon the successful completion of a pre-clinical toxicology study and IND submission related to an antibody the Company acquired from a third party to be used in research, development, manufacturing and commercialization. The amount was capitalized as an indefinite-lived intangible asset; and
• An amount of KUSD 600 paid upon final regulatory approval of ZYNLONTA related to a license agreement with a third party to use their technology to research, develop, manufacture and commercialize products. The amount was capitalized as a definite-lived intangible asset and will be amortized over its estimated useful life of 14 years based on the expected patent life, which includes an extension period that the Company believes is highly probable of being granted. This estimated useful life does not include additional patent protection that may be granted under applications filed but not yet approved other than the extension period discussed above.
License Payments
• An amount of KUSD 250 paid relating to a license agreement with a third party to acquire an antibody to be used in research, development, manufacturing and commercialization. The amount was capitalized as an indefinite-lived intangible asset.
18
The table below provides a rollforward of the Company’s intangible assets as of June 30, 2022 and 2021.
| (in KUSD) | Indefinite lived | Definite lived | |||||||||||||||||||||||||||
| Cost | Licenses | Internal development costs | Licenses | Software | Total | ||||||||||||||||||||||||
| January 1, 2022 | |||||||||||||||||||||||||||||
| Additions | |||||||||||||||||||||||||||||
| Exchange differences | ( | ( | |||||||||||||||||||||||||||
| June 30, 2022 | |||||||||||||||||||||||||||||
| Accumulated Amortization | |||||||||||||||||||||||||||||
| January 1, 2022 | ( | ( | ( | ( | |||||||||||||||||||||||||
| Amortization charge | ( | ( | ( | ||||||||||||||||||||||||||
| Exchange differences | |||||||||||||||||||||||||||||
| June 30, 2022 | ( | ( | ( | ( | |||||||||||||||||||||||||
| Net book amount as of June 30, 2022 | |||||||||||||||||||||||||||||
| Cost | |||||||||||||||||||||||||||||
| January 1, 2021 | |||||||||||||||||||||||||||||
| Additions | |||||||||||||||||||||||||||||
| Transfers | ( | ( | ( | ||||||||||||||||||||||||||
| June 30, 2021 | |||||||||||||||||||||||||||||
| Accumulated Amortization | |||||||||||||||||||||||||||||
| January 1, 2021 | ( | ( | ( | ||||||||||||||||||||||||||
| Amortization charge | ( | ( | ( | ||||||||||||||||||||||||||
| June 30, 2021 | ( | ( | ( | ( | |||||||||||||||||||||||||
| Net book amount as of June 30, 2021 | |||||||||||||||||||||||||||||
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12.Interest in joint venture
On December 14, 2020, the Company announced the formation of a new joint venture company, Overland ADCT BioPharma, with Overland Pharmaceuticals (“Overland”), a fully integrated biopharmaceutical company backed by Hillhouse Capital. Overland ADCT BioPharma will develop and commercialize one of the Company’s ADC products, ZYNLONTA, and three of the Company’s ADC product candidates, ADCT-601, ADCT-602 and ADCT-901, in greater China and Singapore. The table below provides a rollforward of the Company’s interest in Overland ADCT BioPharma as of June 30, 2022 and 2021, respectively.
| (in KUSD) | ||||||||
| Interest in joint venture | ||||||||
| January 1, 2022 | ||||||||
| Share of results in joint venture | ( | |||||||
| June 30, 2022 | ||||||||
| January 1, 2021 | ||||||||
| Share of results in joint venture | ( | |||||||
| June 30, 2021 | ||||||||
As of June 30, 2022, the deferred gain of USD 23.5 million arising from the Company’s contribution for its equity investment in the joint venture remained unchanged from December 31, 2021. The Company’s carrying value of its investment in a joint venture increases or decreases in relation to the Company’s proportionate share of comprehensive income or loss of the joint venture. When the Company’s share of losses of a joint venture exceeds the Company’s interest in that joint venture less the carrying value of the deferred gain described above, the Company ceases to recognize its share of further losses. Additional losses are recognized only to the extent that the Company has incurred legal or constructive obligations or made payments on behalf of the joint venture.
The tables below provide summarized financial information for Overland ADCT BioPharma that is material to the Company. The following information reflects the amounts presented in the financial statements of Overland ADCT BioPharma and not the Company’s share of those amounts.
| (in KUSD) | As of | |||||||||||||||||||||||||
| Summarized Balance Sheet | June 30, 2022 | December 31, 2021 | ||||||||||||||||||||||||
| Cash and cash equivalents | ||||||||||||||||||||||||||
| Prepaid and other current assets | ||||||||||||||||||||||||||
| Intangible assets | ||||||||||||||||||||||||||
| Total liabilities | ||||||||||||||||||||||||||
| Net assets | ||||||||||||||||||||||||||
| Summarized Statement of Comprehensive Loss | Three months ended June 30, | Six months ended June 30, | ||||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||||||||||||
| Operating expenses | ||||||||||||||||||||||||||
| Net loss | ||||||||||||||||||||||||||
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13.Leases
The table below provides a rollforward of the Company's right-of-use assets as of June 30, 2022 and 2021, respectively.
| (in KUSD) | ||||||||||||||||||||
| Right-of-Use Assets | Properties (Offices) | Vehicles | Total | |||||||||||||||||
| Cost | ||||||||||||||||||||
| January 1, 2022 | ||||||||||||||||||||
| Exchange difference | ( | ( | ||||||||||||||||||
| June 30, 2022 | ||||||||||||||||||||
| Accumulated depreciation | ||||||||||||||||||||
| January 1, 2022 | ( | ( | ( | |||||||||||||||||
| Depreciation charge | ( | ( | ( | |||||||||||||||||
| Exchange difference | ||||||||||||||||||||
| June 30, 2022 | ( | ( | ( | |||||||||||||||||
| Net book amount as of June 30, 2022 | ||||||||||||||||||||
| Cost | ||||||||||||||||||||
| January 1, 2021 | ||||||||||||||||||||
| Additions | ||||||||||||||||||||
| Lease termination | ( | ( | ||||||||||||||||||
| Exchange difference | ||||||||||||||||||||
| June 30, 2021 | ||||||||||||||||||||
| Accumulated depreciation | ||||||||||||||||||||
| January 1, 2021 | ( | ( | ( | |||||||||||||||||
| Depreciation charge | ( | ( | ( | |||||||||||||||||
| Lease termination | ||||||||||||||||||||
| Exchange difference | ( | ( | ||||||||||||||||||
| June 30, 2021 | ( | ( | ( | |||||||||||||||||
| Net book amount as of June 30, 2021 | ||||||||||||||||||||
Depreciation of right-of-use assets have been charged to the following categories in the unaudited condensed consolidated interim statement of operations. Depreciation expense for S&M expenses was not material for any of the periods presented.
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||||||||||||
| (in KUSD) | 2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||||
| R&D expenses | ||||||||||||||||||||||||||
| G&A expenses | ||||||||||||||||||||||||||
21
The table below provides a rollforward of the Company's lease liabilities as of June 30, 2022 and 2021, respectively.
| (in KUSD) | ||||||||||||||||||||
| Lease liabilities | Properties (Offices) | Vehicles | Total | |||||||||||||||||
| January 1, 2022 | ||||||||||||||||||||
| Cash outflow (including interest) | ( | ( | ( | |||||||||||||||||
| Interest | ||||||||||||||||||||
| Exchange difference | ( | ( | ( | |||||||||||||||||
| June 30, 2022 | ||||||||||||||||||||
| January 1, 2021 | ||||||||||||||||||||
| Additions | ||||||||||||||||||||
| Cash outflow (including interest) | ( | ( | ( | |||||||||||||||||
| Interest | ||||||||||||||||||||
| Exchange difference | ( | ( | ( | |||||||||||||||||
| June 30, 2021 | ||||||||||||||||||||
| June 30, 2022 | ||||||||||||||||||||
| Lease liabilities (short-term) | ||||||||||||||||||||
| Lease liabilities (long-term) | ||||||||||||||||||||
| Total lease liabilities | ||||||||||||||||||||
| June 30, 2021 | ||||||||||||||||||||
| Lease liabilities (short-term) | ||||||||||||||||||||
| Lease liabilities (long-term) | ||||||||||||||||||||
| Total lease liabilities | ||||||||||||||||||||
14.Convertible loans
Facility agreement
On April 24, 2020, the Company entered into a USD 115 million Facility Agreement with Deerfield Partners, L.P. and certain of its affiliates (“Deerfield”). Pursuant to such agreement, Deerfield agreed to extend senior secured convertible term loans to the Company in two separate disbursements:
(i)an initial disbursement of convertible loans in the amount of USD 65 million upon the completion of the initial public offering (“IPO”), and satisfaction of certain other conditions (the “first tranche”) and
(ii)a subsequent disbursement of convertible loans in the amount of USD 50 million upon the receipt of regulatory approval for ZYNLONTA, and satisfaction of certain other conditions (the “second tranche”).
The outstanding principal amount of the convertible loans is due to be repaid in full on May 19, 2025. However, any conversion of the convertible loans into common shares shall be deemed a repayment of the principal amount of the convertible loans so converted.
The convertible loans bear interest at a rate of 5.95 % per annum, based on a 360-day year, with interest payable quarterly in arrears commencing July 1, 2020 and July 1, 2021 for the first tranche and second tranche, respectively.
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Upon any payment of the convertible loans or conversion of the convertible notes, whether upon redemption or at maturity or at any other time, the Company will be required to pay an exit charge equal to 2.0 % of the amount of the loans so paid or converted.
The Company’s obligations under the Facility Agreement are guaranteed by the Company’s wholly owned subsidiaries and secured by a perfected, first-priority security interest in substantially all of the Company’s and its wholly owned subsidiaries’ personal property, including its intellectual property and the equity ownership interests directly and indirectly held by the Company in its wholly owned subsidiaries and joint venture.
In accordance with the terms of the convertible notes, both the holders and the Company may elect to redeem the notes upon the occurrence of a major transaction and successor major transaction, respectively, as discussed in the Company’s annual report for the period ended December 31, 2021 on Form 20-F.
The Facility Agreement contains various covenants, including a requirement to retain USD 50 million in cash and cash equivalents as of the end of each fiscal quarter.
First tranche - Initial disbursement of convertible loans
The Company has accounted for the first tranche of convertible loans amounting to USD 65 million issued on May 19, 2020 as comprising two components: an embedded conversion option derivative and a loan.
Valuation of derivative embedded in first tranche
Since issuance, the embedded conversion option derivative is marked-to-market on a quarterly basis. During the three and six months ended June 30, 2022, the Company recognized income of KUSD 8,860 and KUSD 18,378 , respectively, as a result of changes in the fair value of the embedded derivative. During both the three and six months ended June 30, 2021, the Company recognized income of KUSD 5,512 and KUSD 20,780 , respectively. The fair value of the embedded derivative associated with the first tranche was KUSD 4,848 and KUSD 23,226 as of June 30, 2022 and December 31, 2021, respectively. The decreases in the fair value of the embedded derivative during the three and six months ended June 30, 2022 and 2021 was primarily due to the decrease in the fair value of the underlying shares from December 31, 2021 to June 30, 2022 and from December 31, 2020 to June 30, 2021, respectively, which were charged directly to the unaudited condensed consolidated interim statement of operations. See note 8, "Non-operating income (expense)" for further information.
The Company used an independent valuation firm to assist in calculating the fair value of the embedded conversion option derivative, which is based on the mean of values derived from application of the Hull and Goldman Sachs convertible bond pricing models. Key inputs for the valuations as of June 30, 2022 and December 31, 2021 were as follows:
| As of | |||||||||||
| June 30, 2022 | December 31, 2021 | ||||||||||
Exercise price at | |||||||||||
Forced conversion price, in USD (1) | |||||||||||
| Share price in USD | |||||||||||
| Risk-free interest rate | % | % | |||||||||
| Expected volatility | % | % | |||||||||
| Expected term | |||||||||||
| Dividend yield | |||||||||||
| Recovery rate | % | % | |||||||||
| Implied bond yield | % | % | |||||||||
(1) In accordance with the terms of the convertible loans, under certain circumstances the Company has the right to force conversions of the convertible notes on and after the one- and three-year anniversaries of the date on which it has received regulatory approval of ZYNLONTA as discussed in the Company’s annual report for the period ended December 31, 2021 on Form 20-F.
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Residual convertible loan
The loan bears interest at a rate of 5.95 % per annum, based on a 360-day year, with interest payable quarterly in arrears commencing on July 1, 2020. For the three and six months ended June 30, 2022, the Company recorded interest expense related to the interest payable on the residual convertible loan (net of the value of the embedded conversion option derivative) in the amount of KUSD 2,313 and KUSD 4,532 , respectively. For the three and six months ended June 30, 2021, the Company recorded interest expense on the residual convertible loan (net of the value of the embedded conversion option derivative) in the amount of KUSD 2,060 and KUSD 4,042 , respectively. The Company’s interest expense is based on the implied effective interest rate, which was computed at inception at 23 %.
The amount at which the convertible loan is presented as a liability in the unaudited condensed consolidated interim balance sheet represents the net present value of all future cash outflows associated with the loan discounted at the implied effective interest rate. The net present value of those cash outflows occurring within 12 months of the balance sheet date discounted at the same rate is presented as a short-term liability. The remainder of the amount is presented as a long-term liability. The carrying value of the convertible loan was KUSD 45,451 as of June 30, 2022, of which KUSD 3,629 was the current portion of the liability. The carrying value of the convertible loan was KUSD 42,874 as of December 31, 2021, of which KUSD 3,631 was the current portion of the liability.
Second tranche - Accounting for subsequent disbursement of convertible loans prior to FDA approval
Draw-down of the second tranche of the convertible loans was mandatory upon the April 23, 2021 receipt of regulatory approval for ZYNLONTA. Prior to drawing down the second tranche, the Company accounted for the second tranche as a derivative. The Company performed a valuation of the derivative immediately prior to the April 23, 2021 approval of ZYNLONTA, which resulted in a mark-to-market adjustment and recognition of KUSD 4,263 of expense and KUSD 1,638 of income for the three and six months ended June 30, 2021, respectively. The increase in fair value of the derivative from April 1, 2021 through immediately prior to the April 23, 2021 FDA approval was primarily due to the increase in the fair value of the underlying shares as well as utilizing a 100% probability of achieving regulatory approval of ZYNLONTA, which was charged directly to the unaudited condensed consolidated interim statement of operations. The decrease in fair value of the derivative during the six months ended June 30, 2021 is primarily due to the decrease in the fair value of the underlying shares from December 31, 2020 to immediately prior to the April 23, 2021 FDA approval, which was charged directly to the unaudited condensed consolidated interim statement of operations. The fair value of the derivative associated with the second tranche as of both June 30, 2022 and December 31, 2021 was nil as the derivative was accounted for as an embedded conversion option derivative upon the draw-down of the subsequent disbursement. See “Second tranche - Accounting for subsequent disbursement of convertible loans after FDA approval” below and note 8, "Non-operating income (expense)" for further details.
The Company used an independent valuation firm to assist in performing a fair value assessment of the derivative liability, which is based on the mean of values derived from application of the Hull and Goldman Sachs convertible bond pricing models. Key inputs for the valuation as of April 23, 2021 (prior to FDA approval of ZYNLONTA) was as follows:
| As of | ||||||||
| April 23, 2021 | ||||||||
Exercise price at | ||||||||
Forced conversion price, in USD (2) | ||||||||
Share price in USD (3) | ||||||||
| Risk-free interest rate | % | |||||||
Expected volatility (4) | % | |||||||
| Expected term | ||||||||
| Dividend yield | ||||||||
| Recovery rate | % | |||||||
| Implied bond yield | % | |||||||
(1) The conversion price for the second tranche of convertible notes is the lesser of (i) 150 % of the IPO price and (ii) 120 % of the average of the volume-weighted average prices of the Company’s common shares on each of the 15 trading days
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immediately prior to the disbursement date of the second tranche, but in no event less than a floor equal to 81 % of the IPO price.
(2) In accordance with the terms of the convertible loans, under certain circumstances the Company has the right to force conversions of the convertible notes on and after the one- and three-year anniversaries of the date on which it received regulatory approval of ZYNLONTA, as discussed in the Company’s annual report for the period ended December 31, 2021 on Form 20-F.
(3) The Company utilized the opening share price on April 23, 2021 for the valuation of the derivative immediately prior to the FDA approval of ZYNLONTA.
(4) The expected volatility utilized for the pre-FDA approval valuations was higher than the post-approval valuations due to a change in the peer group. Prior to the FDA approval of ZYNLONTA, the Company utilized a peer group primarily comprised of clinical-stage companies. Upon receipt of FDA approval of ZYNLONTA, the Company updated the peer group to primarily comprise of commercial-stage companies, which lowered the expected volatility assumption utilized in the post-FDA approval valuations.
Second tranche - Accounting for subsequent disbursement of convertible loans after FDA approval
Upon receipt of FDA approval of ZYNLONTA, the Company accounted for the second tranche of convertible loans amounting to USD 50 million issued on May 17, 2021 as comprising two separate components: an embedded conversion option derivative and a loan.
Valuation of derivative embedded in second tranche
Upon receipt of FDA approval of ZYNLONTA, the Company used an independent valuation firm to assist in calculating the initial fair value of the entire instrument, including the embedded conversion option derivative. The fair value of the embedded conversion option derivative component was based on the mean of values derived from application of the Hull and Goldman Sachs convertible bond pricing models. Key inputs for the subsequent valuation of the embedded conversion option derivative as of June 30, 2022 and December 31, 2021, including both components described above, were as follows:
| As of | ||||||||||||||
| June 30, 2022 | December 31, 2021 | |||||||||||||
Exercise price in USD (1) | ||||||||||||||
Forced conversion price, in USD (2) | ||||||||||||||
| Share price in USD | ||||||||||||||
| Risk-free interest rate | % | % | ||||||||||||
| Expected volatility | % | % | ||||||||||||
| Expected term | ||||||||||||||
| Dividend yield | ||||||||||||||
| Recovery rate | % | % | ||||||||||||
| Implied bond yield | % | % | ||||||||||||
(1) The conversion price for the second tranche of convertible notes is the lesser of (i) 150 % of the IPO price and (ii) 120 % of the average of the volume-weighted average prices of the Company’s common shares on each of the 15 trading days immediately prior to the disbursement date of the second tranche, but in no event less than a floor equal to 81 % of the IPO price. The conversion price for the second tranche of the convertible notes as of June 30, 2022 and December 31, 2021 was based on 120 % of the average of the volume-weighted average process of the Company’s shares on each of the 15 trading days prior to the disbursement date.
During the three and six months ended June 30, 2022, the Company recognized income of KUSD 5,595 and KUSD 11,932 , respectively, as a result of changes in the fair value of the embedded derivative. The fair value of the embedded derivative
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associated with the second tranche was KUSD 2,789 as of June 30, 2022. The decrease in fair value of the embedded derivative is primarily due to the decrease in the fair value of the underlying shares from December 31, 2021 to June 30, 2022. During both the three and six months ended June 30, 2021, the Company recognized expense of KUSD 1,012 as a result of changes in the fair value of the embedded derivative after the April 23, 2021 approval date. The increase in fair value of the embedded derivative during this period is primarily due to an increase in the fair value of the underlying shares from April 23, 2021 to June 30, 2021. The fair value of the embedded derivative associated with the second tranche was KUSD 14,721 as of December 31, 2021. See note 8, "Non-operating income (expense)" for further information.
Convertible loan
The loan bears interest at a rate of 5.95 % per annum, based on a 360-day year, with interest payable quarterly in arrears commencing on July 1, 2021. For the three and six months ended June 30, 2022, the Company recorded interest expense related to the interest payable on the convertible loan (net of the value of the embedded conversion option derivative) in the amount of KUSD 813 and KUSD of 1,616 , respectively, based on the implied effective interest rate, which was computed at inception at 6.7 %. For both the three and six months ended June 30, 2021, the Company recorded interest expense related to the interest payable on the convertible loan (net of the value of the embedded conversion option derivative) in the amount of KUSD 390 based on the implied effective interest rate.
As described above, the Company used an independent valuation firm to assist in calculating the initial fair value of the entire instrument, including both components. The convertible loan is subsequently measured at its amortized cost in accordance with IFRS 9. The amount at which the convertible loan is presented as a liability in the unaudited condensed consolidated interim balance sheet represents the net present value of all future cash outflows associated with the loan discounted at the implied effective interest rate. The net present value of those cash outflows occurring within 12 months of the balance sheet date discounted at the same rate is presented as a short-term liability. The remainder of the amount is presented as a long-term liability. The carrying value of the convertible loan was KUSD 50,966 as of June 30, 2022, of which KUSD 2,944 was the current portion of the liability. The carrying value of the convertible loan was KUSD 50,854 as of December 31, 2021, of which KUSD 2,944 was the current portion of the liability.
Other
In connection with the receipt of the USD 50 million subsequent disbursement, the establishment of the embedded derivative and residual loan associated with the subsequent disbursement and elimination of the aforementioned derivative immediately prior to FDA approval of ZYNLONTA, the Company recorded a gain of KUSD 1,816 during the three and six months ended June 30, 2021, which was recorded in Convertible loans, derivatives, change in fair value income (expense) in the unaudited condensed consolidated interim statement of operations. See note 8, "Non-operating income (expense)" for further information.
On June 4, 2021, in accordance with the Facility Agreement, the Company filed a registration statement to register 5,558,318 common shares, being the maximum number of shares that could potentially be issuable upon conversion of the full amount of the convertible notes issued under the Facility Agreement to the extent that the holders of the convertible notes elect to convert into the Company's common shares or if the Company forces conversion.
15.Share-based compensation
Equity Incentive Plan 2019
In November 2019, the Company adopted the Equity Incentive Plan 2019. Under the Equity Incentive Plan 2019, 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 restricted share units (“RSUs”), share options, share appreciation rights, performance awards and other share-based awards. The Company has reserved 13,820,000 common shares for future issuance under the Equity Incentive Plan 2019 (including share-based equity awards granted to date less awards forfeited). As of June 30, 2022, the Company has 1,769,901 common shares available for the future issuance of share-based equity awards. On March 7, 2022, the Company issued its annual equity award, which was approved by the Compensation Committee of the Board of Directors and consisted of 1,867,076 share options and 570,340 RSUs. On May 11, 2022, the Company issued a special retention award to select employees, which was approved by the Compensation Committee of the Board of
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Directors and consisted of 1,298,700 RSU's. As of June 30, 2022, the Company has only granted share options, RSUs and performance awards under the Equity Incentive Plan 2019.
As of June 30, 2022, the cumulative amount recorded as an increase to Other Reserves within equity in the unaudited condensed consolidated interim balance sheet of the Equity Incentive Plan 2019 was KUSD 123,194 . An amount of KUSD 512 was withheld for tax charges during the three months ended March 31, 2022. There were no amounts withheld for tax charges during the three months ended June 30, 2022. The amount of expense for all awards recognized for services received during the three and six months ended June 30, 2022 were KUSD 13,818 and KUSD 27,728 , respectively, and for the three and six months ended June 30, 2021 were KUSD 18,267 and KUSD 32,218 , respectively.
Share Options
Pursuant to the Equity Incentive Plan 2019, 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 Equity Incentive Plan 2019 have been accounted for as equity-settled under IFRS 2. 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 interim statement of operations and a corresponding increase to Other Reserves within equity on the unaudited condensed consolidated interim balance sheet.
The expense recognized for services received during the three and six months ended June 30, 2022 was KUSD 8,450 and KUSD 18,965 , respectively. The expense recognized for services received during the three and six months ended June 30, 2021 was KUSD 15,315 and KUSD 28,007 , respectively.
The following table summarizes the share option awards outstanding as of June 30, 2022:
| Average strike price per share in USD | Number of awards | Weighted average remaining life in years | |||||||||||||||
| December 31, 2021 | |||||||||||||||||
| Granted | |||||||||||||||||
| Forfeited | ( | N/A | |||||||||||||||
| June 30, 2022 | |||||||||||||||||
Awards outstanding as of June 30, 2022 and December 31, 2021, expire through 2032. The options granted during 2022 include the Company’s annual equity award discussed above. The grant-date fair value of the options relating to the annual equity awards was USD 8.85 per share. As of June 30, 2022, 3,073,399 awards are vested and exercisable out of the total outstanding awards of 9,297,044 common shares. The weighted average strike price and weighted average remaining life for vested and exercisable awards is USD 25.76 and 7.87 years, respectively.
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The fair values of the options granted were determined on the date of the grant using the Black-Scholes option-pricing model. The Company used an independent 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, 2022 were determined on the date of the grant using the following assumptions:
| Three Months Ended | Six Months Ended | ||||||||||
| June 30, 2022 | June 30, 2022 | ||||||||||
| Share price, in USD | |||||||||||
| Strike price, in USD | |||||||||||
| Expected volatility | |||||||||||
| Award life | |||||||||||
| Expected dividends | |||||||||||
| Risk-free interest rate | |||||||||||
The expected volatility was based on the Company’s historical volatility and selected volatility determined by median values observed among other comparable public companies.
The award life is 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 Equity Incentive Plan 2019, 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 three years commencing on the first anniversary of the date of grant. The special retention awards discussed above vest 50 % and the remainder at the six-month and one year anniversaries, respectively, of the grant date. Under the grant, the RSUs may be settled only in common shares of the Company. Therefore, the grants of RSUs under the Equity Incentive Plan 2019 have been accounted for as equity-settled under IFRS 2. 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 interim statement of operations and a corresponding increase to Other Reserves within equity on the unaudited condensed consolidated interim balance sheet.
The expense recognized for services received during the three and six months ended June 30, 2022 was KUSD 5,368 and KUSD 8,763 , respectively. The expense recognized for services received during the three and six months ended June 30, 2021 was KUSD 2,952 and KUSD 4,211 , respectively.
| Number of awards | Weighted average grant date fair value | ||||||||||
| December 31, 2021 | |||||||||||
| Granted | |||||||||||
| Vested | ( | ||||||||||
| Forfeited | ( | ||||||||||
| June 30, 2022 | |||||||||||
The RSUs granted during 2022 include the annual equity award and special retention award discussed above, which had grant date fair values of $14.00 and $6.93 , respectively.
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Share-based Compensation Reserves
The movement in the Share-based Compensation Reserves (included in Other reserves within equity) is as follows:
| Three months ended | Six months ended | ||||||||||||||||||||||
| (in KUSD) | June 30, 2022 | June 30, 2021 | June 30, 2022 | June 30, 2021 | |||||||||||||||||||
| Equity Incentive Plan 2019 - Share Options | |||||||||||||||||||||||
| Equity Incentive Plan 2019 - RSUs | |||||||||||||||||||||||
| Tax and social charge deductions - Incentive Plan 2019 | ( | ||||||||||||||||||||||
| Total | |||||||||||||||||||||||
16.Deferred royalty obligation
On August 25, 2021, the Company entered into a royalty purchase agreement with HCR for up to USD 325.0 million of which the Company received gross proceeds of USD 225.0 million during 2021 and is eligible to receive an additional USD 100.0 million upon the occurrence of certain commercial milestones.
The table below provides a rollforward of the Company’s debt obligation relating to the royalty purchase agreement.
| (in KUSD) | ||||||||
| January 1, 2022 | ||||||||
| Less: royalty payments | ||||||||
| Plus: interest expense | ||||||||
| Less: cumulative catch-up adjustment, Financial income (expense), net | ||||||||
| June 30, 2022 | ||||||||
| January 1, 2021 | ||||||||
| Proceeds from the sale of future royalties | ||||||||
| Less: transaction costs | ||||||||
| Less: royalty payments | ||||||||
| Plus: interest expense | ||||||||
| Plus: cumulative catch-up adjustment, Financial expense | ||||||||
| December 31, 2021 | ||||||||
The Company recorded a liability relating to the initial gross proceeds received less transaction costs. The Company will record additional liabilities upon the receipt of eligible amounts when such contingent events occur. To determine the accretion of the liability related to the deferred royalty obligation, the Company is required to estimate the total amount of future royalty payments and estimated timing of such payment to HCR based on the Company's revenue projections. Based on the Company's initial revenue projections, the Company used an independent valuation firm to assist in determining the total amount of future royalty payments and estimated timing of such payment to HCR using an option pricing Monte Carlo simulation model. The amount ultimately received by the Company will be accreted to the total amount of the royalty payments necessary to extinguish the Company’s obligation under the agreement, which will be recorded as interest expense over the life of the royalty purchase agreement. The estimate of this total interest expense resulted in an effective interest rate of 10 %. As royalty payments are made to HCR, the balance of the debt obligation will be effectively repaid over the life of the royalty purchase agreement.
Based on the Company's periodic review, the exact amount and timing of repayment is likely to be different each reporting period as compared to those estimated based on the Company's initial revenue projections. A significant increase or decrease in actual net sales of ZYNLONTA compared to the Company’s revenue projections, and regulatory approval and commercialization of Cami, as well as ZYNLONTA in other indications as well as licensing revenue could change the royalty rate and royalty cap due to HCR, which could materially impact the debt obligation as well as interest expense associated with the royalty purchase agreement. Also, the Company’s total obligation to HCR can vary depending on the
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17.Related parties
Parties are considered to be related if one party has the ability, directly or indirectly, to control the other party or exercise significant influence over the other party in making financial and operating decisions.
A.T. Holdings II Sàrl (“AT Holdings II”) is a shareholder in the Company. AT Holdings II is in turn ultimately wholly owned by Auven Therapeutics Holdings, L.P. (“ATH”), a limited partnership registered in the British Virgin Islands. ATH’s General Partner is Auven Therapeutics General L.P., which itself is a limited partnership whose General Partner is Auven Therapeutics GP Ltd. The manager of ATH is Auven Therapeutics Management L.L.L.P. (“ATM”).
Based on the Company’s contribution and equity interest in Overland ADCT BioPharma, certain of the Company’s employees serve on its board of directors.
Services provided by the Company to related parties
The Company provides registered office and other simple administrative services to three subsidiaries of ATH. The amounts invoiced for the three and six months ended June 30, 2022 and recovered through G&A expenses, amounted to nil and KUSD 1 , respectively (three and six months ended June 30, 2021: KUSD 1 and KUSD 2 , respectively).
As contemplated by the license agreement with Overland ADCT BioPharma, Overland ADCT BioPharma has elected to participate in certain of the Company’s global clinical trials, in exchange for which it reimburses the Company for a portion of the cost of those trials. Overland ADCT BioPharma also reimburses the Company for certain expenses in connection with technology transfer and assistance of clinical personnel. During the three and six months ended June 30, 2022, the Company incurred KUSD 876 and KUSD 1,196 , respectively, of clinical trial and service costs to be reimbursed by Overland ADCT BioPharma, which is recorded as a reduction of R&D expenses in the Company’s unaudited condensed consolidated interim statement of operations (three and six months ended June 30, 2021: KUSD 790 ).
In addition, the Company entered into a supply agreement with Overland ADCT BioPharma whereby the Company provides Overland ADCT BioPharma clinical supply for use in trials. For the three and six months ended June 30, 2022, nil and KUSD 45 , respectively, of clinical supply was provided to Overland ADCT BioPharma which is recorded as a reduction of R&D expenses in the Company’s unaudited condensed consolidated interim statement of operation. There were no such sales to Overland ADCT BioPharma during the three and six months ended June 30, 2021.
Related party balances
The Company had a related party receivable balance with Overland ADCT BioPharma of KUSD 876 and KUSD 789 as of June 30, 2022 and December 31, 2021, respectively. There were no trade accounts payable with related parties as of June 30, 2022 and December 31, 2021.
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Key management compensation
The compensation of key management is shown below:
| Three months ended June 30, | Six months ended June 30, | ||||||||||||||||||||||
| (in KUSD) | 2022 | 2021 | 2022 | 2021 | |||||||||||||||||||
| Salaries and other short-term employee costs | |||||||||||||||||||||||
| Pension costs | |||||||||||||||||||||||
| Share-based compensation expense | |||||||||||||||||||||||
| Other compensation | |||||||||||||||||||||||
| Total | |||||||||||||||||||||||
During the second quarter of 2022, there was an organizational realignment of certain key management as a result of the appointment of the Company's new CEO. The key management compensation for the three and six months ended June 30, 2022 reflects the new management structure, while the comparable prior periods have not been recast to conform to the current structure.
18.Loss per share
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
| (in KUSD, except per share amounts) | 2022 | 2021 | 2022 | 2021 | |||||||||||||||||||
| Loss attributable to owners | ( | ( | ( | ( | |||||||||||||||||||
Weighted average number of shares outstanding | |||||||||||||||||||||||
| Basic and diluted loss per share | ( | ( | ( | ( | |||||||||||||||||||
For the three and six months ended June 30, 2022 and 2021, basic and diluted loss per share are calculated on the weighted average number of shares issued and outstanding and exclude shares to be issued under the Equity Incentive Plan 2019, as the effect of including those shares would be anti-dilutive.
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:
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
| Equity Incentive Plan 2019 - Share Options | |||||||||||||||||||||||
| Equity Incentive Plan 2019 - RSUs | |||||||||||||||||||||||
| Conversion of the principal amount of convertible loans into the Company’s common shares | |||||||||||||||||||||||
19.Events after the reporting date
The Company has evaluated its subsequent events through August 9, 2022, the date the financial statements were available to be issued, and has concluded that there are no subsequent events requiring disclosure in the financial statements, other than those described below.
During July 2022, the Company entered into exclusive license agreement with Sobi for the development and commercialization of ZYNLONTA for all hematologic and solid tumor indications outside of the U.S., greater China, Singapore and Japan. Under the terms of the agreement, the Company received an upfront payment of USD 55 million and is eligible to receive up to USD 382.5 million in regulatory and net sales-based milestones, including USD 50 million upon approval of a Marketing Authorisation Application by the European Commission for ZYNLONTA in third-line DLBCL. The Company will also receive
31
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Exhibit 99.2
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
This management’s discussion and analysis is designed to provide you with a narrative explanation of our financial condition and results of operations. You should read this discussion and analysis in conjunction with our unaudited condensed consolidated interim financial statements, including the notes thereto, as of and for the three and six months ended June 30, 2022 included as Exhibit 99.1 to the Report on Form 6-K to which this discussion and analysis is included as Exhibit 99.2. You should also read this discussion and analysis in conjunction with our audited consolidated financial statements, including the notes thereto, included in our Annual Report on Form 20-F for the year ended December 31, 2021.
Our unaudited condensed consolidated interim financial statements were prepared in accordance with International Accounting Standard 34, Interim Financial Reporting. Our audited consolidated financial statements were prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board (“IFRS”). None of our financial statements were prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”). The terms “dollar,” “USD” or “$” refer to U.S. dollars and the term “Swiss franc” and “CHF” refer to the legal currency of Switzerland, unless otherwise indicated. We have made rounding adjustments to some of the figures included in this discussion. Accordingly, any numerical discrepancies in any table between totals and sums of the amounts listed are due to rounding.
Unless otherwise indicated or the context otherwise requires, all references in this discussion and analysis to “ADC Therapeutics” or “ADCT,” the “Company,” “we,” “our,” “ours,” “us” or similar terms refer to ADC Therapeutics SA and its consolidated subsidiaries.
Overview
We are a commercial-stage biotechnology company improving the lives of cancer patients with our next-generation, targeted antibody drug conjugates (“ADCs”) for patients with hematologic malignancies and solid tumors. We develop our ADCs by applying our decades of experience in this field and using both next-generation pyrrolobenzodiazepine (“PBD”) technology to which we have proprietary rights for our targets as well as novel antibody constructs and payloads.
By leveraging our R&D strengths, our disciplined approach to target selection and our preclinical and clinical development strategy, we have created a diverse and balanced portfolio and research pipeline. Our hematology franchise comprises one approved product (ZYNLONTA, formerly known as loncastuximab tesirine or Lonca) and two clinical-stage product candidates, camidanlumab tesirine (“Cami” and previously known as ADCT-301) and ADCT-602. Our solid tumor franchise comprises three clinical-stage product candidates, Cami, ADCT-601 (mipasetamab uzoptirine) and ADCT-901, and two preclinical product candidates, ADCT-701 and ADCT-212.
Our flagship product, ZYNLONTA, received accelerated approval from the FDA on April 23, 2021 for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (“DLBCL”) not otherwise specified, DLBCL arising from low-grade lymphoma, and also high-grade B-cell lymphoma. The broad patient population included in the label is a key point of differentiation for ZYNLONTA. In a pivotal Phase 2 clinical trial for the treatment of relapsed or refractory DLBCL, ZYNLONTA demonstrated significant clinical activity across a broad population of heavily pre-treated patients, achieving a 48.3% overall response rate (“ORR”) and a 24.8% complete response rate (“CRR”), while maintaining a manageable tolerability profile. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients with high-grade B-cell lymphoma and patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. In the most recent data cut as of March 1, 2021, patients who received ZYNLONTA had a median duration of response (“DoR”) of 13.4 months for all responders, and the median DoR was not reached for patients with a complete response. We believe that ZYNLONTA has a current addressable patient population of approximately 6,000 patients in the United States, and our experienced commercial organization is unlocking this market opportunity by engaging physicians regarding ZYNLONTA’s differentiated product profile. Shortly after approval, ZYNLONTA was added to the NCCN Clinical Practice Guidelines for Oncology (NCCN Guidelines) with a Category 2A recommendation for third-line-plus DLBCL patients, which reflects the broad label and the differentiated profile of ZYNLONTA.
To further expand the market opportunity for ZYNLONTA and maximize its commercial potential, we are conducting LOTIS-5, a confirmatory Phase 3 clinical trial of ZYNLONTA in combination with rituximab that, if successful, we believe
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will serve as the basis for a supplemental BLA (“sBLA”) for ZYNLONTA for the treatment of relapsed or refractory DLBCL in second-line transplant-ineligible patients. We have completed the safety-run in portion of this trial with 20 patients dosed, and we are now enrolling the randomized phase of the trial. The combination appears to be well tolerated, we did not observe any safety events materially different from those observed in prior clinical trials, and the initial data suggests the agents are additive in terms of efficacy. In addition, we have initiated LOTIS-9, a Phase 2 clinical trial of ZYNLONTA in combination with rituximab in previously untreated unfit or frail patients with DLBCL who are not eligible for R-CHOP. Finally, we have also initiated LOTIS-7, a Phase-1b clinical trial of ZYNLONTA in combination with other anti-cancer agents in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. The first patient was dosed with ZYNLONTA in combination with polatuzumab vedotin.
We are committed to providing global access to ZYNLONTA to patients who may benefit from treatment. In Europe, our Marketing Authorisation Application (“MAA”) for ZYNLONTA for the treatment of relapsed or refractory DLBCL has been validated by the European Medicines Agency (“EMA”), which enabled the evaluation process by the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) to begin. On September 13, 2021, we received Orphan Drug Designation in the European Union for ZYNLONTA for the treatment of DLBCL, which was granted by the European Commission based on a positive opinion issued by the EMA Committee for Orphan Medicinal Products. We expect the European Commission regulatory decision by the first quarter of 2023.
In China, our joint venture with Overland Pharmaceuticals, Overland ADCT BioPharma (CY) Limited, is continuing to advance the development of ZYNLONTA and has completed enrollment in a pivotal Phase 2 clinical trial of single-agent ZYNLONTA for the treatment of relapsed or refractory DLBCL in China. This local pivotal study mirrors our ongoing global pivotal Phase 2 clinical trial of ZYNLONTA and its results are intended to support the potential registration of ZYNLONTA in China. In addition, the first patient has been dosed in China as part of our LOTIS-5 confirmatory Phase 3 clinical trial. In Japan, we entered an exclusive license agreement with Mitsubishi Tanabe Pharma Corporation (“MTPC”) for the development and commercialization of ZYNLONTA for all hematologic and solid tumor indications. We entered an exclusive license agreement with Swedish Orphan Biovitrum AB (“Sobi”) for the development and commercialization of ZYNLONTA for all hematologic and solid tumor indications in Europe and all other jurisdictions outside of the U.S., Japan, greater China and Singapore.
Our next clinical-stage product candidate, Cami, has demonstrated significant clinical activity across a broad population of heavily pre-treated patients with Hodgkin Lymphoma (“HL”), while maintaining a tolerability profile that we believe is manageable. We are evaluating Cami in a 117-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory HL. Patients had a median of six lines of prior systemic therapy. As of November 1, 2021, interim data from 117 patients showed a 70.1% ORR and a 33.3% CRR and a tolerability profile that we believe is manageable. Patients who received Cami had a median DoR of 13.7 months for all responders, and a median DoR of 14.5 months for patients with a complete response. We are preparing for a potential BLA submission for Cami and plan to have a pre-BLA meeting with the FDA in September 2022. We expect to submit the complete BLA for Cami in HL to the FDA in the second half of 2023. We are also evaluating Cami in a Phase 1b clinical trial as a novel immuno-oncology approach for the treatment of various advanced solid tumors. This clinical trial is currently enrolling patients and evaluates Cami in combination with pembrolizumab, a checkpoint inhibitor, to better understand its potential as both a monotherapy and in combination.
In addition to ZYNLONTA and Cami, we have multiple clinical and pre-clinical stage products. ADCT-901 is a novel, first-in-class candidate targeting KAAG-1 for the treatment of patients with advanced solid tumors. The Phase 1 trial is currently in dose escalation. We are conducting a Phase 1b trial for ADCT-601 (mipasetamab uzoptirine), targeting AXL, as a single agent and in combination with gemcitabine in patients with selected advanced solid tumors. Finally, we are completing IND enabling work for our ADCT-701 (targeting DLK-1) and ADCT-212 (PSMA) programs.
Impact of the COVID-19 Pandemic
As the COVID-19 pandemic continues to evolve, we believe its impact to our operations, operating results, cash flows, liquidity and financial condition will be primarily driven by its severity and duration, its impact on the U.S. and global economies and the timing, the availability, acceptance and effectiveness of vaccines and treatments, particularly against emerging variants of the novel coronavirus, and the scope and effectiveness of national and local governmental responses to the pandemic. Those primary drivers are beyond our knowledge and control, and as a result, the ultimate impact of the COVID-19 pandemic on our results of operations, cash flows and financial position for the remainder of 2022 and thereafter cannot be reasonably predicted. We are conducting our operations in compliance with official guidance and containment measures related to the pandemic, and we are working proactively with our partners and other stakeholders to take steps to mitigate any negative impact of the COVID-19 pandemic on our operations. Our employees are meeting with investigators and site staff in person as allowed by institutions.
•Clinical Programs: We continue to closely monitor the potential effect of the COVID-19 pandemic on our clinical trials, as well as the supply of our product candidates and will work closely with our clinical trial sites, contract
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research organizations and contract manufacturing partners to mitigate any such impact. The ultimate impact of the COVID-19 pandemic is highly uncertain and subject to change.
•Commercial Launch of ZYNLONTA: We have built our launch plans for ZYNLONTA specifically to mitigate to the best of our ability the impact of the ongoing COVID-19 pandemic. Our Commercial and Medical Affairs teams prepared for a hybrid launch. Face-to-face interactions with physicians are a key pillar of our continued success in driving the adoption of ZYNLONTA through ongoing dialogs with the healthcare provider community on ZYNLONTA's differentiated product profile. Access to physicians continued to improve in May and June. The ultimate impact of the COVID-19 pandemic is highly uncertain and subject to change.
Recent Developments
Recent Transactions
In July 2022, we entered an exclusive license agreement with Swedish Orphan Biovitrum AB (“Sobi”) for the development and commercialization of ZYNLONTA for all hematologic and solid tumor indications outside of the U.S., greater China, Singapore and Japan. Under the agreement, we received an upfront payment of USD 55 million and are eligible to receive up to USD 382.5 million in regulatory and net sales-based milestones, including USD 50 million upon the approval of a MAA by the European Commission for ZYNLONTA in third-line DLBCL, as well as tiered royalties ranging from mid-teens to the mid-twenties based on net sales of ZYNLONTA in the licensed territories, subject to certain adjustments. Sobi will also contribute 25 percent of clinical trial costs for select global ZYNLONTA trials, up to a cap of USD 10 million per year. For further information on the license agreement, see our Report on Form 6-K filed with the SEC on July 11, 2022.
Clinical Program Updates
ZYNLONTA
LOTIS-9. On July 20, 2022, we announced that the first patient has been dosed in LOTIS-9, a Phase 2 clinical trial evaluating ZYNLONTA in combination with rituximab in previously untreated unfit/frail patients with DLBCL. The primary objectives of the Phase 2 clinical trial are to assess the efficacy of a response-adapted treatment of Lonca-R in unfit participants with previously untreated DLBCL and to assess the tolerability and efficacy of a response-adapted treatment of Lonca-R in frail participants with previously untreated DLBCL who are unlikely to tolerate the usual combination treatment with R-CHOP. For further information on LOTIS-9, see our Report on Form 6-K filed with the SEC on July 20, 2022.
LOTIS-7. On June 29, 2022, we announced that the first patient has been dosed in LOTIS-7, a Phase 1b clinical trial evaluating ZYNLONTA in combination with other anti-cancer agents in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. The first arm of the LOTIS-7 open-label, multi-center, multi-arm Phase 1b trial will evaluate the safety and activity of ZYNLONTA in combination with polatuzumab vedotin in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. The trial will include multiple arms in two parts – a dose escalation part and a dose expansion part.
LOTIS-6. We have decided to terminate the LOTIS-6 trial. The Phase 2 clinical trial was designed to evaluate the efficacy of ZYNLONTA compared to idelalisib in patients with relapsed or refractory follicular lymphoma (“FL”). Due to the withdrawal of idelalisib as a treatment for relapsed or refractory FL in the United States, this trial is no longer feasible or relevant. We continue to believe in ZYNLONTA's potential as a treatment for FL and we plan to explore opportunities for novel combinations with ZYNLONTA in FL.
Cami
On June 10, 2022, we announced results from the ongoing pivotal Phase 2 clinical trial of Cami in relapsed or refractory HL. The single-arm, multicenter, open-label clinical trial is evaluating Cami in 117 patients with r/r Hodgkin lymphoma who have received ≥3 prior lines of treatment (≥2 lines if ineligible for hematopoietic stem cell transplantation, HSCT). Patients received a median of 6 prior lines of systemic therapy. The efficacy and safety findings are summarized below:
•ORR of 70.1% and CR rate of 33.3% in patients with a median of 6 prior treatments
•Median duration of response (DOR) was 13.7 months and median progression-free survival (PFS) was 9.1 months; patients who achieved a CR had a median DOR of 14.5 months
•14 patients received HSCT following treatment with Cami
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•The most common grade ≥3 treatment-emergent adverse events in ≥5% of patients were: thrombocytopenia (9.4%), anemia (8.5%), hypophosphatemia (7.7%), neutropenia (7.7%), maculopapular rash (6.8%) and lymphopenia (5.1%)
•8/117 patients developed Guillain-Barré syndrome/polyradiculopathy. GBS symptoms could be mitigated with careful medical intervention.
ADCT-601
On July 27, 2022 we announced that the first patient has been dosed in the Phase 1b clinical trial evaluating ADCT-601 (mipasetamab uzoptirine) targeting AXL. The Phase 1b open-label, dose-escalation and dose-expansion clinical trial evaluates the safety and tolerability of ADCT-601 as a single agent and in combination with gemcitabine in patients with selected advanced solid tumors. The first arm of the trial will enroll approximately 18 patients with sarcoma, a tumor resistant to current available cancer treatments in which AXL is overexpressed.
Corporate Updates
On June 30, 2022, at our annual general meeting, our shareholders elected Ameet Mallik and Jean-Pierre Bizzari to our board of directors. Mr. Mallik and Dr. Bizzari’s biographical information is contained in our Report on Form 6-K filed with the U.S. Securities and Exchange Commission on June 30, 2022.
On July 1, 2022, David Gilman joined our company as our Chief Business & Strategy Officer. Mr. Gilman is responsible for all business development and portfolio strategy efforts globally. From April 2019 to June 2022, Mr. Gilman was a partner with ClearView Healthcare Partners. From May 2018 to April 2019, he served as the Global Head of Portfolio Strategy and Business Development of Novartis Oncology. Prior to that, he was a Managing Director with The Frankel Group and Huron Consulting Group. Mr. Gilman holds an M.B.A. from the Texas McCombs School of Business. There are no family relationships between Mr. Gilman and any of our directors or executive officers.
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Results of Operations
Comparison of the Three Months Ended June 30, 2022 and 2021
The following table summarizes our results of operations for the three months ended June 30, 2022 and 2021:
| Three Months Ended June 30, | |||||||||||||||||||||||
| in KUSD | 2022 | 2021 | Change | ||||||||||||||||||||
| Product revenues, net | 17,291 | 3,760 | 13,531 | ||||||||||||||||||||
| Total revenue | 17,291 | 3,760 | 13,531 | ||||||||||||||||||||
| Operating expense | |||||||||||||||||||||||
| Cost of product sales | (2,266) | (121) | (2,145) | ||||||||||||||||||||
| Research and development expenses | (48,537) | (39,533) | (9,004) | ||||||||||||||||||||
| Selling and marketing expenses | (17,659) | (15,221) | (2,438) | ||||||||||||||||||||
| General and administrative expenses | (18,240) | (19,367) | 1,127 | ||||||||||||||||||||
| Total operating expense | (86,702) | (74,242) | (12,460) | ||||||||||||||||||||
| Loss from operations | (69,411) | (70,482) | 1,071 | ||||||||||||||||||||
| Other income (expense) | |||||||||||||||||||||||
| Financial income | 16 | 15 | 1 | ||||||||||||||||||||
| Financial expense | (8,801) | (2,555) | (6,246) | ||||||||||||||||||||
Non-operating income (1) | 12,875 | 693 | 12,182 | ||||||||||||||||||||
| Total other (expense) income | 4,090 | (1,847) | 5,937 | ||||||||||||||||||||
| Loss before taxes | (65,321) | (72,329) | 7,008 | ||||||||||||||||||||
| Income tax benefit (expense) | 947 | (240) | 1,187 | ||||||||||||||||||||
| Net loss | (64,374) | (72,569) | 8,195 | ||||||||||||||||||||
(1) Prior to December 31, 2021, individual components of Non-operating income were reported separately within the statement of operations. Prior periods have been recast to conform to the current period presentation. See Note 8, “Non-operating income (expense)” to the unaudited condensed consolidated interim financial statements for further information.
Notable items other than revenue from product sales and license revenue impacting the results of operations for the three months ended June 30, 2022 and 2021 included:
| Three Months Ended June 30, | |||||||||||||||||||||||
| in KUSD | P&L Classification | 2022 | 2021 | Change | |||||||||||||||||||
| Impairment of assets | Cost of product sales | 1,862 | — | 1,862 | |||||||||||||||||||
| Share-based compensation | Research and development (“R&D”) expenses | 4,844 | 5,687 | (843) | |||||||||||||||||||
| Share-based compensation | Selling and marketing (“S&M”) expenses | 1,671 | 2,721 | (1,050) | |||||||||||||||||||
| Share-based compensation | General and administrative (“G&A”) expenses | 7,303 | 9,859 | (2,556) | |||||||||||||||||||
| Fair value adjustment of Facility Agreement derivatives | Non-operating income | 14,455 | 2,053 | 12,402 | |||||||||||||||||||
| Share of Overland ADCT BioPharma net loss | Non-operating income | 1,917 | 1,169 | 748 | |||||||||||||||||||
| Effective interest on the first and second tranche convertible loans | Financial expense | 3,126 | 2,450 | 676 | |||||||||||||||||||
| Accretion expense of deferred royalty obligation | Financial expense | 5,545 | — | 5,545 | |||||||||||||||||||
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Revenue
Product revenue
On April 23, 2021, we received accelerated approval from the FDA for ZYNLONTA for the treatment of relapsed or refractory DLBCL and launched in the U.S. shortly thereafter. To date, our only source of product revenue, which commenced during May 2021, has been from sales of ZYNLONTA. Product revenues, net increased to USD 17.3 million for the three months ended June 30, 2022 from USD 3.8 million for the three months ended June 30, 2021, an increase of USD 13.5 million due to a full quarter of sales activity in the second quarter of 2022. Our revenue may fluctuate from period to period based on a number of factors including, but not limited to, patient demand, as well as the timing, dose and duration of patient therapy and customers’ buying patterns, including their building of inventory.
Cost of sales
Cost of product sales increased to USD 2.3 million for the three months ended June 30, 2022 from USD 0.1 million for the three months ended June 30, 2021, an increase of USD 2.1 million primarily associated with USD 1.7 million of impairment charges related to the manufacturing of antibodies that did not meet our specifications. The specification issues did not, and are not expected to, impact the company’s ability to supply commercial product. In addition, cost of product sales increased due to a full second quarter of sales activity in 2022 as compared to the comparable period in 2021 due to the commencement of ZYNLONTA sales in May 2021. Cost of product sales primarily consisted of direct and indirect costs relating to the manufacture of ZYNLONTA from third-party providers of manufacturing, distribution and logistics services, intangible asset amortization expense, impairment charges and royalties paid to a collaboration partner based on net product sales of ZYNLONTA.
R&D expenses
The following table summarizes our R&D expenses for the three months ended June 30, 2022 and 2021:
| Three Months Ended June 30, | |||||||||||||||||
| in KUSD | 2022 | 2021 | Change | ||||||||||||||
External costs 1 | 30,175 | 21,983 | 8,192 | ||||||||||||||
Employee expense 2 | 18,362 | 17,550 | 812 | ||||||||||||||
| R&D expenses | 48,537 | 39,533 | 9,004 | ||||||||||||||
1 Includes depreciation expense
2 Includes share-based compensation expense
Our R&D expenses increased to USD 48.5 million for the three months ended June 30, 2022 from USD 39.5 million for the three months ended June 30, 2021, an increase of USD 9.0 million, or 22.8%. As a result of FDA approval of ZYNLONTA in April 2021, the Company reversed KUSD 6,752 of previously recorded impairment charges during the three months ended June 30, 2021, relating to inventory costs incurred for the manufacture of product prior to FDA approval. External costs increased primarily as a result of higher chemistry, manufacturing and controls ("CMC") expense due to manufacturing activities to support the ADCT-212 program during the three months ended June 30, 2022 as well as our continued clinical trials to expand the potential market opportunities for ZYNLONTA in earlier lines of therapy and new histologies, advance Cami to support a BLA submission and build our pipeline. Employee expense increased primarily due to higher employee headcount.
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The following table summarizes our R&D expenses for our major development programs for the three months ended June 30, 2022 and 2021:
| Three Months Ended June 30, | ||||||||||||||||||||
| in KUSD | 2022 | 2021 1 | Change | |||||||||||||||||
| ZYNLONTA | 19,875 | 15,564 | 4,311 | |||||||||||||||||
| Cami | 8,681 | 8,108 | 573 | |||||||||||||||||
| ADCT-602 | 285 | 252 | 33 | |||||||||||||||||
| ADCT-601 | 1,808 | 3,312 | (1,504) | |||||||||||||||||
| ADCT-901 | 1,300 | 1,809 | (509) | |||||||||||||||||
| Preclinical product candidates and research pipeline | 8,355 | 2,782 | 5,573 | |||||||||||||||||
| Not allocated to specific programs | 3,389 | 2,019 | 1,370 | |||||||||||||||||
| Share-based compensation expense | 4,844 | 5,687 | (843) | |||||||||||||||||
| R&D expenses | 48,537 | 39,533 | 9,004 | |||||||||||||||||
1 Prior to June 30, 2022, share-based compensation expense was allocated to the major development programs and preclinical product candidates and research pipeline. Prior periods have been recast to conform to the current period presentation.
R&D expenses for our major development programs will fluctuate from period to period primarily due to the nature and timing associated with the various lifecycle stages of each program, including but not limited to early R&D activities; manufacturing of clinical drug product; clinical trial activity; costs associated with the regulatory approval process; and manufacturing costs associated with commercialization activities prior to the receipt of regulatory approval.
As a result of FDA approval of ZYNLONTA in April 2021, the Company reversed KUSD 6,752 of previously recorded impairment charges during the three months ended June 30, 2021, relating to inventory costs incurred for the manufacture of product prior to FDA approval. R&D expenses related to ZYNLONTA increased due to the undertaking of clinical trials to expand the potential market opportunities for ZYNLONTA in earlier lines of therapy and histologies, which was partially offset by lower CMC expenses due to the absence of pre-launch commercial supply activities that were performed during the three months ended June 30, 2021.
The increase in R&D expenses related to Cami was primarily due to higher personnel costs and CMC expenses as various development activities to support ongoing clinical trial activity occurred during the three months ended June 30, 2022. This increase was partially offset by a decrease in clinical trial activity as the pivotal Phase 2 trial for HL entered into the follow-up stage.
The decrease in R&D expenses related to ADCT-601 was primarily due to lower CMC expenses partially offset by higher clinical expenses.
The increase in R&D expenses related to Preclinical product candidates and research pipeline was primarily due to higher expenses related to IND-enabling work for ADCT-212 and the continued advancement of our preclinical pipeline during the three months ended June 30, 2022.
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S&M expenses
The following table summarizes our S&M expenses for the three months ended June 30, 2022 and 2021:
| Three Months Ended June 30, | |||||||||||||||||
| in KUSD | 2022 | 2021 | Change | ||||||||||||||
External costs 1 | 9,259 | 5,726 | 3,533 | ||||||||||||||
Employee expense 2 | 8,400 | 9,495 | (1,095) | ||||||||||||||
| S&M expenses | 17,659 | 15,221 | 2,438 | ||||||||||||||
1 Includes depreciation expense relating to Property, plant and equipment. All other depreciation expense was not material for the three months ended June 30, 2021.
2 Includes share-based compensation expense.
Our S&M expenses increased to USD 17.7 million for the three months ended June 30, 2022 from USD 15.2 million for the three months ended June 30, 2021, an increase of USD 2.4 million, or 16.0%. External costs increased primarily as a result of higher professional expenses relating to the commercial launch of ZYNLONTA. Employee expense decreased primarily as a result of lower share-based compensation expense.
G&A expenses
The following table summarizes our G&A expenses for the three months ended June 30, 2022 and 2021:
| Three Months Ended June 30, | |||||||||||||||||
| in KUSD | 2022 | 2021 | Change | ||||||||||||||
External costs 1 | 5,880 | 5,872 | 8 | ||||||||||||||
Employee expense 2 | 12,360 | 13,495 | (1,135) | ||||||||||||||
| G&A expenses | 18,240 | 19,367 | (1,127) | ||||||||||||||
1 Includes depreciation expense
2 Includes share-based compensation expense
Our G&A expenses decreased to USD 18.2 million for the three months ended June 30, 2022 from USD 19.4 million for the three months ended June 30, 2021, a decrease of USD 1.1 million, or 5.8%. Employee expense for the three months ended June 30, 2022 decreased to USD 12.4 million primarily as a result of lower share-based compensation expense.
Other income (expense)
The following table summarizes our other income for the three months ended June 30, 2022 and 2021:
| Three Months Ended June 30, | ||||||||||||||||||||
| in KUSD | 2022 | 2021 | Change | |||||||||||||||||
| Financial income | 16 | 15 | 1 | |||||||||||||||||
| Financial expense | (8,801) | (2,555) | (6,246) | |||||||||||||||||
| Non-operating income | 12,875 | 693 | 12,182 | |||||||||||||||||
| Total other income (expense) | 4,090 | (1,847) | 5,937 | |||||||||||||||||
Financial income
Our financial income for the three months ended June 30, 2022 was virtually flat as compared to the three months ended June 30, 2021.
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Financial expense
Our financial expense increased to USD 8.8 million for the three months ended June 30, 2022 from USD 2.6 million for the three months ended June 30, 2021. The increase was primarily due to interest expense related to the accretion of our deferred royalty obligation with HCR and the interest on the convertible loans, calculated at their respective implied effective interest rate. Financial expense for the three months ended June 30, 2021 did not include interest expense relating to the deferred royalty obligation with HCR as the transaction was entered into during August 2021. Our accounting of these expenses is explained in note 16, “Deferred royalty obligation” and note 14, “Convertible loans”, respectively, to the unaudited condensed consolidated interim financial statements.
Non-operating income (expense)
Convertible loans, derivatives, change in fair value income (expense)
Changes in convertible loans, derivatives, change in fair value was income of USD 14.5 million and USD 2.1 million for the three months ended June 30, 2022 and 2021, respectively. Pursuant to the Facility Agreement with Deerfield, we drew down the first and second tranches of the convertible loans amounting to USD 65 million and USD 50 million on May 19, 2020 and May 17, 2021, respectively. The increase in income as a result of changes in convertible loans, derivatives and change in fair value for the three months ended June 30, 2022 and 2021 was primarily due to the decrease in the fair value of the underlying shares. Our accounting for these changes in our derivative fair values is explained in note 14, “Convertible loans” to the unaudited condensed consolidated interim financial statements.
Share of Results with Joint Venture
We recorded our proportionate share of Overland ADCT BioPharma’s net loss of USD 1.9 million and USD 1.2 million for the three months ended June 30, 2022 and 2021, respectively. Our share of ADCT BioPharma's net loss increased as ADCT BioPharma expanded its clinical trial activities. See note 12, “Interest in joint venture” within the notes to the unaudited condensed consolidated interim financial statements for further details.
Exchange differences
Due to our international operations, we are exposed to foreign exchange risk arising from various currency exposures, primarily with respect to British pounds, Euros and Swiss francs. Our exchange differences represent gain or (loss) based on favorable or unfavorable changes in foreign currencies. Favorable changes in foreign currencies resulted in a gain of USD 0.2 million for the three months ended June 30, 2022, as compared to a loss of USD 0.2 million for the three months ended June 30, 2021.
R&D Tax Credit
We recognize amounts received and receivable by our subsidiary, ADC Therapeutics (UK) Limited, under the United Kingdom’s R&D Expenditure Credit scheme. For the three months ended June 30, 2022 and 2021, we recognized income of KUSD 114 and KUSD 199, respectively, in connection with our R&D tax credits. See note 8, “Non-operating income (expense)” within the unaudited condensed consolidated interim financial statements for further details.
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Income tax expense
We recorded an income tax benefit of KUSD 947 and income tax expense of KUSD 240 for the three months ended June 30, 2022 and 2021, respectively. On the basis of our projections of future taxable income, we recognized KUSD 4,576 of a deferred income tax benefit related to R&D tax credits and temporary differences related to our U.S. subsidiary during the three months ended June 30, 2022. The net income tax benefit recorded is primarily the result of current income tax benefit derived in the U.S. from its foreign-derived intangible income deduction. This benefit reduces our effective rate from the statutory rate of 21% in the U.S. We did not recognize any deferred tax assets during the three months ended June 30, 2021 as we had not yet received approval of ZYNLONTA. Our current income tax expense was KUSD 3,629 and KUSD 240 for the three months ended June 30, 2022 and 2021, respectively, and is primarily due to our internal arrangements to reimburse our foreign subsidiaries in the U.S. and the United Kingdom for the services they render to our parent company in Switzerland. Commercial sales in the U.S. also contributed to the current period income tax expense. Ultimately, the net profit at each subsidiary is subject to local income tax.
In estimating future taxable income, management develops assumptions including the amount of future net revenue and pre-tax operating income and the implementation of feasible and prudent tax planning strategies. These assumptions require significant judgment about the forecasts of future taxable income and are consistent with the plans and estimates we are using to manage the underlying business. Management notes that its projections of future taxable profits rely on currently enacted law and are subject to revision if the U.S. legislates new tax law. As such, changes in tax laws and rates could also affect recorded deferred tax assets and liabilities in the future. We record the effect of a tax rate or law change on our deferred tax assets and liabilities in the period of enactment. Future tax rate or law changes could have a material effect on our financial condition, results of operations or cash flows.
Comparison of the Six Months Ended June 30, 2022 and 2021
The following table summarizes our results of operations for the six months ended June 30, 2022 and 2021:
For the Six Months Ended June 30, | |||||||||||||||||
| in KUSD | 2022 | 2021 | Change | ||||||||||||||
| Product revenues, net | 33,789 | 3,760 | 30,029 | ||||||||||||||
| License revenue | 30,000 | — | 30,000 | ||||||||||||||
| 63,789 | 3,760 | 60,029 | |||||||||||||||
| Operating expense | |||||||||||||||||
| Cost of product sales | (2,795) | (121) | (2,674) | ||||||||||||||
| Research and development expenses | (97,489) | (78,705) | (18,784) | ||||||||||||||
| Selling and marketing expenses | (36,029) | (29,132) | (6,897) | ||||||||||||||
| General and administrative expenses | (37,251) | (36,949) | (302) | ||||||||||||||
| Total operating expense | (173,564) | (144,907) | (28,657) | ||||||||||||||
| Loss from operations | (109,775) | (141,147) | 31,372 | ||||||||||||||
| Other income (expense) | |||||||||||||||||
| Financial income | 18,324 | 30 | 18,294 | ||||||||||||||
| Financial expense | (18,018) | (4,555) | (13,463) | ||||||||||||||
Non-operating income (1) | 26,317 | 21,923 | 4,394 | ||||||||||||||
| Total other income | 26,623 | 17,398 | 9,225 | ||||||||||||||
| Loss before taxes | (83,152) | (123,749) | 40,597 | ||||||||||||||
| Income tax benefit (expense) | 2,117 | (347) | 2,464 | ||||||||||||||
| Net loss | (81,035) | (124,096) | 43,061 | ||||||||||||||
(1) Prior to December 31, 2021, individual components of Non-operating income (expense) were reported separately within the statement of operations. Prior periods have been recast to conform to the current period presentation. See Note 8, “Non-operating income (expense)” to the unaudited condensed consolidated interim financial statements for further information.
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Notable items other than revenue from product sales and license revenue impacting the results of operations for the six months ended June 30, 2022 and 2021 included:
| Six Months Ended June 30, | |||||||||||||||||||||||
| in KUSD | P&L Classification | 2022 | 2021 | Change | |||||||||||||||||||
| Impairment of assets | Cost of product sales | 1,862 | — | 1,862 | |||||||||||||||||||
| Share-based compensation | R&D expenses | 9,788 | 8,556 | 1,232 | |||||||||||||||||||
| Share-based compensation | S&M expenses | 3,709 | 4,682 | (973) | |||||||||||||||||||
| Share-based compensation | G&A expenses | 14,231 | 18,980 | (4,749) | |||||||||||||||||||
| Fair value adjustment of Facility Agreement derivatives | Non-operating income | 30,310 | 23,222 | 7,088 | |||||||||||||||||||
| Share of Overland ADCT BioPharma net loss | Non-operating income | 4,419 | 1,696 | 2,723 | |||||||||||||||||||
| Effective interest on the first and second tranche convertible loans | Financial expense | 6,148 | 4,432 | 1,716 | |||||||||||||||||||
| Cumulative catch-up adjustment of deferred royalty obligation | Financial income | 18,288 | — | 18,288 | |||||||||||||||||||
| Accretion expense of deferred royalty obligation | Financial expense | 11,687 | — | 11,687 | |||||||||||||||||||
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Revenue
Product revenues
On April 23, 2021, we received accelerated approval from the FDA for ZYNLONTA for the treatment of relapsed or refractory DLBCL and launched in the U.S. shortly thereafter. To date, the Company’s only source of product revenue, which commenced during May 2021, has been from sales of ZYNLONTA. Product revenues, net increased to USD 33.8 million for the six months ended June 30, 2022, from USD 3.8 million for the six months ended June 30, 2021, an increase of USD 30.0 million, due to a full half-year of sales activity in 2022. Our revenue may fluctuate from period to period based on a number of factors including, but not limited to, patient demand, as well as the timing, dose and duration of patient therapy and customers’ buying patterns, including their building of inventory.
License revenue
On January 18, 2022, we entered into an exclusive license agreement with MTPC for the development and commercialization of ZYNLONTA for all hematologic and solid tumor indications in Japan. Under the terms of the agreement, we received an upfront payment of USD 30 million, which was recorded as license revenue within the unaudited condensed consolidated interim statement of operations. See note 5, "Revenue recognition" to the unaudited condensed consolidated interim financial statements for further information.
Cost of sales
Cost of product sales increased to USD 2.8 million for the six months ended June 30, 2022 from USD 0.1 million for the six months ended June 30, 2021, an increase of USD 2.7 million primarily associated with USD 1.7 million of impairment charges related to the manufacturing of antibodies that did not meet our specifications. The specification issues did not, and are not expected to, impact the company’s ability to supply commercial product. In addition, cost of product sales increased due to a full half-year of sales activity in 2022 as compared to the comparable period in 2021 due to the commencement of ZYNLONTA sales in May 2021. Cost of product sales primarily consisted of direct and indirect costs relating to the manufacture of ZYNLONTA from third-party providers of manufacturing, distribution and logistics services, intangible asset amortization expense, impairment charges and royalties paid to a collaboration partner based on net product sales of ZYNLONTA.
The following table summarizes our R&D expenses for the six months ended June 30, 2022 and 2021:
| Six Months Ended June 30, | |||||||||||||||||
| in KUSD | 2022 | 2021 | Change | ||||||||||||||
External costs 1 | 59,343 | 46,289 | 13,054 | ||||||||||||||
Employee expense 2 | 38,146 | 32,416 | 5,730 | ||||||||||||||
| R&D expenses | 97,489 | 78,705 | 18,784 | ||||||||||||||
1 Includes depreciation expense
2 Includes share-based compensation expense
Our R&D expenses increased to USD 97.5 million for the six months ended June 30, 2022 from USD 78.7 million for the six months ended June 30, 2021, an increase of USD 18.8 million, or 23.9%. As a result of FDA approval of ZYNLONTA in April 2021, the Company reversed KUSD 6,752 of previously recorded impairment charges during the six months ended June 30, 2021, relating to inventory costs incurred for the manufacture of product prior to FDA approval. External costs increased primarily as a result of higher chemistry, manufacturing and controls ("CMC") expense due to manufacturing activities to support the ADCT-212 program during the six months ended June 30, 2022 as well as our continued clinical trials to expand the potential market opportunities for ZYNLONTA in earlier lines of therapy and new histologies, advance Cami to support a BLA submission and build our pipeline. Employee expense increased primarily due to higher employee headcount.
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The following table summarizes our R&D expenses for our major development programs for the six months ended June 30, 2022 and 2021:
| Six Months Ended June 30, | |||||||||||||||||
| in KUSD | 2022 | 2021 1 | Change | ||||||||||||||
| ZYNLONTA | 40,165 | 34,805 | 5,360 | ||||||||||||||
| Cami | 18,378 | 17,384 | 994 | ||||||||||||||
| ADCT-602 | 578 | 791 | (213) | ||||||||||||||
| ADCT-601 | 4,442 | 5,329 | (887) | ||||||||||||||
| ADCT-901 | 2,689 | 3,897 | (1,208) | ||||||||||||||
| Preclinical product candidates and research pipeline | 15,458 | 4,300 | 11,158 | ||||||||||||||
| Not allocated to specific programs | 5,991 | 3,643 | 2,348 | ||||||||||||||
| Share-based compensation | 9,788 | 8,556 | 1,232 | ||||||||||||||
| R&D expenses | 97,489 | 78,705 | 18,784 | ||||||||||||||
1 Prior to June 30, 2022, share-based compensation expense was allocated to the major development programs and preclinical product candidates and research pipeline. Prior periods have been recast to conform to the current period presentation.
R&D expenses for our major development programs will fluctuate from period to period primarily due to the nature and timing associated with the various lifecycle stages of each program, including but not limited to early R&D activities; manufacturing of clinical drug product; clinical trial activity; costs associated with the regulatory approval process; and manufacturing costs associated with commercialization activities prior to the receipt of regulatory approval.
As a result of FDA approval of ZYNLONTA in April 2021, the Company reversed KUSD 6,752 of previously recorded impairment charges during the six months ended June 30, 2021, relating to inventory costs incurred for the manufacture of product prior to FDA approval. R&D expenses related to ZYNLONTA increased due to the undertaking of clinical trials to expand the potential market opportunities for ZYNLONTA in earlier lines of therapy and histologies, which was partially offset by lower CMC expenses due to the absence of pre-launch commercial supply activities that were performed during the six months ended June 30, 2021.
The increase in R&D expenses related to Cami was primarily due to higher personnel costs and CMC expenses as various development activities to support ongoing clinical trial activity occurred during the six months ended June 30, 2022. This increase was partially offset by a decrease in clinical trial activity as the pivotal Phase 2 trial for HL entered into the follow-up stage.
The decrease in R&D expenses related to ADCT-601 was primarily due to lower CMC expenses partially offset by higher clinical expenses.
The decrease in R&D expenses related to ADCT-901 was primarily due to lower CMC expenses and preclinical expenses.
The increase in R&D expenses related to Preclinical product candidates and research pipeline was primarily due to higher expenses related to IND-enabling work for ADCT-212 and the continued advancement of our preclinical pipeline during the six months ended June 30, 2022.
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S&M expenses
The following table summarizes our S&M expenses for the six months ended June 30, 2022 and 2021:
| Six Months Ended June 30, | |||||||||||||||||
| in KUSD | 2022 | 2021 | Change | ||||||||||||||
External costs 1 | 18,170 | 11,016 | 7,154 | ||||||||||||||
Employee expense 2 | 17,859 | 18,116 | (257) | ||||||||||||||
| S&M expenses | 36,029 | 29,132 | 6,897 | ||||||||||||||
1 Includes depreciation expense relating to Property, plant and equipment. All other depreciation expense was not material for the six months ended June 30, 2021.
2 Includes share-based compensation expense.
Our S&M expenses increased to USD 36.0 million for the six months ended June 30, 2022 from USD 29.1 million for the six months ended June 30, 2021, an increase of USD 6.9 million, or 23.7%. External costs increased primarily as a result of higher professional fees for the launch of ZYNLONTA. Employee expense decreased primarily as a result of lower share-based compensation expense.
G&A expenses
The following table summarizes our general and administrative expenses for the six months ended June 30, 2022 and 2021:
| Six Months Ended June 30, | |||||||||||||||||
| in KUSD | 2022 | 2021 | Change | ||||||||||||||
External costs 1 | 13,519 | 10,605 | 2,914 | ||||||||||||||
Employee expense 2 | 23,732 | 26,344 | (2,612) | ||||||||||||||
| G&A expenses | 37,251 | 36,949 | 302 | ||||||||||||||
1 Includes depreciation expense
2 Includes share-based compensation expense
Our G&A expenses increased to USD 37.3 million for the six months ended June 30, 2022 from USD 36.9 million for the six months ended June 30, 2021, an increase of USD 0.3 million, or 0.8%. G&A expenses increased primarily due to higher professional fees associated with the license agreement entered into with MTPC. Employee expense for the six months ended June 30, 2022 decreased to USD 23.7 million primarily as a result of lower share-based compensation expense.
Other income (expense)
The following table summarizes our other income and expense for the six months ended June 30, 2022 and 2021:
| Six Months Ended June 30, | |||||||||||||||||
| in KUSD | 2022 | 2021 | Change | ||||||||||||||
| Financial income | 18,324 | 30 | 18,294 | ||||||||||||||
| Financial expense | (18,018) | (4,555) | (13,463) | ||||||||||||||
| Non-operating income | 26,317 | 21,923 | 4,394 | ||||||||||||||
| Total other income | 26,623 | 17,398 | 9,225 | ||||||||||||||
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Financial income
Our financial income increased to KUSD 18,324 for the six months ended June 30, 2022 from KUSD 30 for the six months ended June 30, 2021. The increase was primarily related to the cumulative catch-up adjustment to the deferred royalty obligation with HCR based on the Company's 2022 strategic planning decisions including updated development plans and updated valuation model. See note 16, “Deferred royalty obligation” to the unaudited condensed consolidated interim financial statements.
Financial expense
Our financial expense increased to USD 18.0 million for the six months ended June 30, 2022 from USD 4.6 million for the six months ended June 30, 2021. The increase was primarily due to interest expense related to the accretion of our deferred royalty obligation with HCR and the interest on the convertible loans, calculated at their respective implied effective interest rate. Financial expense for the six months ended June 30, 2021 did not include interest expense relating to the deferred royalty obligation with HCR as the transaction was entered into during August 2021 or the interest expense on the second tranche of the convertible loans as it was drawn down in May 2021. Our accounting of these expenses is explained in note 16, “Deferred royalty obligation” and note 14, “Convertible loans”, respectively, to the unaudited condensed consolidated interim financial statements.
Non-operating income (expense)
Convertible loans, derivatives, change in fair value income (expense)
Changes in convertible loans, derivatives, change in fair value was income of USD 30.3 million and USD 23.2 million for the six months ended June 30, 2022 and 2021, respectively. Pursuant to the Facility Agreement with Deerfield, we drew down the first and second tranches of the convertible loans amounting to USD 65 million and USD 50 million on May 19, 2020 and May 17, 2021, respectively. The increase in income as a result of changes in convertible loans, derivatives and change in fair value was primarily due to the decrease in the fair value of the underlying shares. Our accounting for these changes in derivative fair values is explained in note 14, “Convertible loans”, to the unaudited condensed consolidated interim financial statements.
Share of Results with Joint Venture
We recorded our proportionate share of Overland ADCT BioPharma’s net loss of USD 4.4 million and USD 1.7 million for the six months ended June 30, 2022 and 2021, respectively. Our share of ADCT BioPharma's net loss increased as ADCT BioPharma expanded its clinical trial activities. See note 12, “Interest in joint venture” within the notes to the unaudited condensed consolidated interim financial statements for further details.
Exchange differences
Due to our international operations, we are exposed to foreign exchange risk arising from various currency exposures, primarily with respect to British pounds, Euros and Swiss francs. Our exchange differences represent income or (loss) based on changes in foreign currencies. Favorable and unfavorable changes in foreign currencies resulted in a gain of USD 0.3 million for the six months ended June 30, 2022 as compared to a gain of USD 0.2 million the six months ended June 30, 2021, respectively.
R&D Tax Credit
We recognize amounts received and receivable by our subsidiary, ADC Therapeutics (UK) Limited, under the United Kingdom’s R&D Expenditure Credit scheme. For the six months ended June 30, 2022 and 2021, we recognized income of USD
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0.1 million and USD 0.4 million, respectively, in connection with our R&D tax credits. See note 8, “Non-operating income (expense)” within the unaudited condensed consolidated interim financial statements for further details.
Income tax expense
We recorded an income tax benefit of KUSD 2,117 and income tax expense of KUSD 347 for the six months ended June 30, 2022 and 2021, respectively. On the basis of our projections of future taxable income, we recognized KUSD 8,432 of a deferred income tax benefit related to R&D tax credits and temporary differences related to our U.S. subsidiary during the six months ended June 30, 2022. The net income tax benefit recorded is primarily the result of current income tax benefit derived in the U.S. from its foreign-derived intangible income deduction. This benefit reduces our effective rate from the statutory rate of 21% in the U.S. We did not recognize any deferred tax assets during the six months ended June 30, 2021 as we had not yet received approval of ZYNLONTA. Our current income tax expense was KUSD 6,315 and KUSD 347 for the six months ended June 30, 2022 and 2021, respectively, and is primarily due to our internal arrangements to reimburse our foreign subsidiaries in the U.S. and the United Kingdom for the services they render to our parent company in Switzerland. Commercial sales in the U.S. also contributed to the current period income tax expense. Ultimately, the net profit at each subsidiary is subject to local income tax.
In estimating future taxable income, management develops assumptions including the amount of future net revenue and pre-tax operating income and the implementation of feasible and prudent tax planning strategies. These assumptions require significant judgment about the forecasts of future taxable income and are consistent with the plans and estimates we are using to manage the underlying business. Management notes that its projections of future taxable profits rely on currently enacted law and are subject to revision if the U.S. legislates new tax law. As such, changes in tax laws and rates could also affect recorded deferred tax assets and liabilities in the future. We record the effect of a tax rate or law change on our deferred tax assets and liabilities in the period of enactment. Future tax rate or law changes could have a material effect on our financial condition, results of operations or cash flows.
Liquidity and Capital Resources
Since inception, we have incurred significant net losses. To date, we have financed our operations primarily through equity financings, including our initial public offering and follow-on offering, convertible debt financings, and additional funds provided by collaborations and royalty financings. As of June 30, 2022, we had cash and cash equivalents of USD 376.8 million. We have an at-the-market (“ATM”) offering program, pursuant to which we may sell our common shares with an aggregate offering price of up to USD 200.0 million. There have been no shares sold under the ATM program to date. We plan to continue to fund our operating needs through our existing cash and cash equivalents, revenues from the sale 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 also continuously engaged in discussions to establish value-maximizing strategic collaborations, business combinations, acquisitions, licensing opportunities or similar strategies for clinical development and commercialization of ZYNLONTA and/or our product candidates.
Our primary uses of capital are, and we expect will continue to be, R&D expenses, S&M expenses, compensation and related expenses, interest payments on debt obligations and other operating expenses. We expect to incur substantial expenses in connection with the advancement of clinical trials, including pivotal and confirmatory clinical trials, regulatory submissions for our products, product candidates and research pipeline, and the commercialization of ZYNLONTA. 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.
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Cash Flows
Comparison of the Six Months Ended June 30, 2022 and 2021
The following table summarizes our cash flows for the six months ended June 30, 2022 and 2021:
| (in KUSD) | Six months ended June 30, | ||||||||||||||||
| Net cash (used in) provided by: | 2022 | 2021 | Change | ||||||||||||||
| Operating activities | (86,892) | (113,159) | 26,267 | ||||||||||||||
| Investing activities | (2,137) | (3,505) | 1,368 | ||||||||||||||
| Financing activities | (510) | 49,308 | (49,818) | ||||||||||||||
| Net change in cash and cash equivalents | (89,539) | (67,356) | (22,183) | ||||||||||||||
Net cash used in operating activities
Net cash used in operating activities decreased to USD 86.9 million for the six months ended June 30, 2022 from USD 113.2 million for the six months ended June 30, 2021, a decrease of USD 26.3 million, or 23.2%. The decrease was primarily due to the receipt of the USD 30 million upfront payment from MTPC, partially offset by increased cash expenditures in the period related to operating expenses in advancing development of our pipeline and the continued commercialization of ZYNLONTA.
Net cash used in investing activities
Net cash used in investing activities decreased to USD 2.1 million for the six months ended June 30, 2022 from USD 3.5 million for the six months ended June 30, 2021, a decrease of USD 1.4 million, or 39.0%. The decrease was primarily due to lower capital expenditures and lower intangible asset acquisitions, partially offset by security deposits made during the six months ended June 30, 2022. See note 11, “Intangible assets” to the unaudited condensed consolidated interim financial statements for further information.
Net cash (used in) provided by financing activities
Net cash (used in) provided by financing activities decreased to USD (0.5) million for the six months ended June 30, 2022 compared to USD 49.3 million for the six months ended June 30, 2021. The decrease was primarily due to the receipt of the second tranche of convertible loans under the Facility Agreement during the six months ended June 30, 2021. See note 14, "Convertible loans" to the unaudited condensed consolidated interim financial statements for further information.
Operating Capital Requirements
We expect our expenses, including R&D, S&M, manufacturing and distribution costs, to increase in connection with our ongoing activities, particularly as we continue to commercialize ZYNLONTA, undertake confirmatory and other clinical trials for ZYNLONTA and continue the development of, and seek regulatory approval for, our product candidates. Accordingly, we may need to obtain additional funding in connection with our continuing operations.
As of June 30, 2022, we had cash and cash equivalents of USD 376.8 million. Based on our current business plan, we believe that our existing cash and cash equivalents, forecasted revenue from ZYNLONTA and receipt of forecasted royalty and milestone payments under our license agreements and royalty purchase agreement with HCR will enable us to fund our operating expenses and capital expenditure requirements into early 2025. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect. Our future capital requirements will depend on many factors, which are outlined in our Annual Report on Form 20-F for the year ended December 31, 2021 and our subsequent filings with the SEC, as well as actual versus forecast demand for ZYNLONTA. In addition, we may seek to raise additional capital through debt and equity financings, license agreements and other arrangements and combinations thereof that we believe are in our best interest.
Off-Balance Sheet Arrangements
As of June 30, 2022 and during the periods presented, we did not have, and we do not currently have, any off-balance sheet arrangements.
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Quantitative and Qualitative Disclosures about Market Risk
During the periods presented, there were no significant changes to our quantitative and qualitative disclosures about market risk from those described in the section in our Annual Report on Form 20-F for the year ended December 31, 2021 titled “Item 11. Quantitative and Qualitative Disclosures About Market Risk” with the exception of a hypothetical 10% increase (decrease) in our share price as of June 30, 2022. A hypothetical 10% increase (decrease) in our share price as of June 30, 2022 would have increased (decreased) the derivative values associated with the first tranche and second tranche by USD 1.1 million (USD 1.1 million) and USD 0.6 million (USD 0.6 million), respectively.
We do not believe that inflation had a material effect on our business, financial condition or results of operations. If our costs were to become subject to significant inflationary pressures, we may not be able to fully offset such higher costs through price increases. Our inability or failure to do so could harm our business, financial condition or results of operations.
Critical Accounting Policies and Significant Judgments and Estimates
There have been no material changes to the significant accounting policies and significant judgments and estimates from those described in the section in our Annual Report on Form 20-F for the year ended December 31, 2021 titled “Item 5. Operating and Financial Review and Prospects—E. Critical Accounting Estimates”, other than those described in note 2, “Basis of preparation” and note 3, “Significant accounting policies” to our unaudited condensed consolidated interim financial statements.
Recent Accounting Pronouncements
See note 3, “Significant accounting policies”, to our unaudited condensed consolidated interim financial statements for a description of recent accounting pronouncements applicable to our unaudited condensed consolidated interim financial statements.
Cautionary Statement Regarding Forward-Looking Statements
This discussion contains statements that constitute forward-looking statements. All statements other than statements of historical facts contained in this discussion, including statements regarding our future results of operations and financial position, business and commercial strategy, potential market opportunities, products and product candidates, research pipeline, ongoing and planned preclinical studies and clinical trials, regulatory submissions and approvals, 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 discussion 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 appear in a number of places in this discussion and include, but are not limited to, statements regarding our intent, belief or current expectations. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to 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, those identified under the section in our Annual Report on Form 20-F for the period ended December 31, 2021 titled “Item 3. Key Information—D. Risk Factors” and in our subsequent filings with the SEC. These forward-looking statements include, among others:
•our expectations regarding revenues derived from sales of ZYNLONTA;
•the commencement, timing, progress and results of our R&D programs, preclinical studies and clinical trials;
•the timing of investigational new drug application (“IND”), BLA, sBLA, marketing authorization application (“MAA”) and other regulatory submissions with the FDA, the European Medicines Agency (“EMA”) or comparable regulatory authorities in other jurisdictions;
•the proposed development pathway for ZYNLONTA and Cami, and our other product candidates, and the acceptability of the results of clinical trials for regulatory approval by the FDA, EMA or comparable regulatory authorities in other jurisdictions;
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•assumptions relating to the identification of serious adverse, undesirable or unacceptable side effects related to our products and product candidates;
•the timing of and our ability to obtain and maintain regulatory approval for our product and product candidates;
•our plan for the commercialization of ZYNLONTA and, if approved, for Cami;
•the manufacture and supply of our products and product candidates;
•our expectations regarding the size of the patient populations amenable to treatment with our products and, if approved, product candidates, as well as the treatment landscape of the indications that we are targeting with our products and product candidates;
•assumptions relating to the rate and degree of market acceptance of ZYNLONTA and any other approved products;
•the pricing and reimbursement of ZYNLONTA and any other approved products;
•our ability to identify and develop additional product candidates;
•the ability of our competitors to discover, develop or commercialize competing products before or more successfully than we do;
•our competitive position and the development of and projections relating to our competitors or our industry;
•our estimates of our expenses, revenues, capital requirements, cash runway and need for or ability to obtain additional financing;
•our ability to raise capital when needed in order to continue our R&D programs or commercialization efforts;
•our ability to identify and successfully enter into strategic collaborations or licensing opportunities in the future, and our assumptions regarding any potential revenue that we may generate under current or future collaborations or licensing arrangements;
•our ability to obtain, maintain, protect and enforce intellectual property protection for our products and product candidates, and the scope of such protection;
•ability to operate our business without infringing, misappropriating or otherwise violating the intellectual property rights of third parties;
•our expectations regarding the impact of the COVID-19 pandemic;
•our expectations regarding the impact of the current conflict between Russia and Ukraine, including resulting sanctions and changes in commodities prices, on our business and industry and the financial markets;
•our ability to attract and retain qualified key management and technical personnel;
•our expectations regarding the effectiveness of our internal controls over financial reporting; and
•our expectations regarding the time during which we will be a foreign private issuer.
These forward-looking statements speak only as of the date of this discussion and are subject to a number of risks, uncertainties and assumptions described under the section in our Annual Report on Form 20-F for the year ended December 31, 2021 entitled “Item 3. Key Information—D. Risk Factors” and in our subsequent filings with the SEC. 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. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. 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
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factors and uncertainties. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, 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 discussion, 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.
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Exhibit 99.3

ADC Therapeutics Reports Second Quarter 2022 Financial Results
and Provides Business Updates
and Provides Business Updates
ZYNLONTA® (loncastuximab tesirine-lpyl) net sales of $17.3 million in the second quarter of 2022
Ex-U.S. ZYNLONTA license agreement with Sobi® facilitates global patient access
and extends cash runway into early 2025
Company to host conference call today at 8:30 a.m. EDT
Lausanne, Switzerland, August 9, 2022 – ADC Therapeutics SA (NYSE: ADCT) today reported financial results for the second quarter ended June 30, 2022 and provided business updates.
“The ZYNLONTA® launch is advancing steadily as we continue to increase awareness and advocacy. There is significant opportunity ahead and we have a focused plan in place to achieve continued growth in the coming quarters,” commented Ameet Mallik, Chief Executive Officer of ADC Therapeutics. “Our pipeline of hematology and solid tumor programs is progressing well with impressive Cami Phase 2 data in Hodgkin lymphoma presented at the EHA Congress in June. Our recent license agreement with Sobi® in Europe gives us worldwide access for ZYNLONTA. We have a strong cash runway extending into early 2025 which makes us well-positioned to execute on our key objectives.”
Recent Highlights and Developments
Corporate Update
•Announced an exclusive license agreement with Swedish Orphan Biovitrum AB (Sobi) for the development and commercialization of ZYNLONTA for all hematologic and solid tumor indications outside of the United States, greater China, Singapore and Japan.
•Appointed David Gilman as Chief Business & Strategy Officer.
•Elected veteran oncology drug developer Jean-Pierre Bizzari, MD, and CEO Ameet Mallik to the Company’s Board of Directors.
Hematology Franchise
ZYNLONTA (loncastuximab tesirine-lpyl)
•ZYNLONTA generated net sales of $17.3 million in the second quarter of 2022.
•Initiated LOTIS-9, the Phase 2 clinical trial of ZYNLONTA in combination with rituximab in unfit or frail first-line diffuse large B-cell lymphoma (DLBCL) patients.
•Initiated LOTIS-7, the Phase 1b clinical trial of ZYNLONTA in combination with other anti-cancer agents.
•Terminated LOTIS-6, the Phase 2 clinical trial of ZYNLONTA in patients with relapsed or refractory follicular lymphoma.
•The Overland ADCT BioPharma joint venture enrolled the first patient in China in the global LOTIS-5 confirmatory Phase 3 clinical trial of Lonca and rituximab in second-line or later transplant ineligible DLBCL patients.
•Overland ADCT Biopharma completed enrollment of the single-agent bridging study in third-line+ DLBCL, which forms the basis for submission of a marketing application in China.
Cami (camidanlumab tesirine) in Hodgkin lymphoma
•Released results from the Phase 2 Hodgkin lymphoma (HL) registrational trial at the European Hematology Association (EHA) 2022 Congress in June. These results showed an overall response rate (ORR) of 70%, a complete response (CR) rate of 33% and a median duration of response (DOR) of 13.7 months. Safety data confirmed the manageable tolerability of Cami in these patients.
Solid Tumor Franchise
ADCT-601 (targeting AXL)
•Initiated the Phase 1b combination trial in multiple solid tumors
Upcoming Expected Milestones
Hematology Franchise
ZYNLONTA
•Present LOTIS-5 safety lead-in data at an upcoming medical meeting in 2H 2022
•Receive a regulatory decision for third-line DLBCL from the Committee for Medicinal Products for Human Use (CHMP), a committee of the European Medicines Agency (EMA), by 1Q 2023.
Cami
•Meet with the U.S. Food and Drug Administration (FDA) for HL pre-Biologics License Application (BLA) meeting in September 2022
•Complete BLA submission for HL to the FDA in 2H 2023
Solid Tumor Franchise
Cami (targeting CD25)
•Preliminary results of safety and clinical activity are anticipated in 2023 for the Phase 1b solid tumor trial of Cami in combination with pembrolizumab
ADCT-901 (targeting KAAG1)
•Preliminary results of safety and tumor response for the Phase 1 dose escalation trial in multiple solid tumors are anticipated in 2023
Second Quarter Financial Results
Cash and Cash Equivalents
Cash and cash equivalents were $376.8 million as of June 30, 2022, compared to $466.5 million as of December 31, 2021.
Product Revenue
Product revenue (net) was $17.3 million for the quarter, compared to $3.8 million for the same quarter in 2021. Net revenues are for U.S. sales of ZYNLONTA, which received accelerated approval from the FDA on April 23, 2021.
Cost of product sales
Cost of product sales was $2.3 million for the quarter, compared to $0.1 million for the same quarter in 2021, an increase of $2.1 million associated with $1.9 million of impairment charges primarily related to the
manufacturing of antibodies that was not within the Company's specifications. The specification issues did not, and are not expected to, impact the Company’s ability to supply commercial product. In addition, cost of product sales increased due to a full second quarter of sales activity in 2022 as compared to the same period in 2021 due to the commencement of ZYNLONTA sales in May 2021.
Research and Development (R&D) Expenses
R&D expenses were $48.5 million for the quarter ended June 30, 2022, compared to $39.5 million for the same quarter in 2021. As a result of FDA approval of ZYNLONTA in April 2021, the Company reversed $6.8 million of previously recorded impairment charges during the three months ended June 30, 2021, relating to inventory costs incurred for the manufacture of product prior to FDA approval. In addition, R&D expenses increased due to clinical activities to expand ZYNLONTA’s potential market opportunities in earlier lines of therapy and advance the Company’s portfolio of solid tumor programs.
Selling and Marketing (S&M) Expenses
S&M expenses were $17.7 million for the quarter ended June 30, 2022, as compared to $15.2 million for the same quarter in 2021. The increase in S&M expenses is related to the ongoing launch of ZYNLONTA.
G&A Expenses
G&A expenses were $18.2 million for the quarter ended June 30, 2022, compared to $19.4 million for the same quarter in 2021. G&A expenses decreased primarily due to lower share-based compensation expense.
Net Loss and Adjusted Net Loss
Net loss was $64.4 million, or a net loss of $0.84 per basic and diluted share, for the quarter ended June 30, 2022. This compares to a net loss of $72.6 million, or a net loss of $0.95 per basic and diluted share, for the same quarter in 2021. The decrease in net loss for the quarter ended June 30, 2022, as compared to the same period in 2021, was primarily due to higher product revenue, partially offset by the increase in cost of product sales, R&D and S&M expenses. In addition, net loss decreased for the second quarter of 2022 as a result of income arising from changes in the fair value of derivatives associated with our Deerfield Facility Agreement, partially offset by higher interest expense associated with the deferred obligation with Healthcare Royalty Partners.
Adjusted net loss was $56.3 million, or an adjusted net loss of $0.73 per basic and diluted share, for the quarter ended June 30, 2022. This compares to $53.7 million, or an adjusted net loss of $0.70 per basic and diluted share, for the same quarter in 2021.
Conference Call Details
ADC Therapeutics management will host a conference call and live audio webcast to discuss second quarter 2022 financial results and provide a company update today at 8:30 a.m. Eastern Time. To access the conference call, please register here. Registrants will receive the dial-in number and unique PIN. It is recommended that you join 10 minutes before the event, though you may pre-register at any time. A live webcast of the call will be available under “Events and Presentations” in the Investors section of the ADC Therapeutics website at www.ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call.
About ZYNLONTA® (loncastuximab tesirine-lpyl)
ZYNLONTA® is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.
The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.
About ADC Therapeutics
ADC Therapeutics (NYSE: ADCT) is a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs). The Company is advancing its proprietary PBD-based ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors.
ADC Therapeutics’ CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) is approved by the FDA for the treatment of relapsed or refractory diffuse large b-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in development in combination with other agents. Cami (camidanlumab tesirine) is being evaluated in a pivotal Phase 2 trial for relapsed or refractory Hodgkin lymphoma and in a Phase 1b clinical trial for various advanced solid tumors. In addition to ZYNLONTA and Cami, ADC Therapeutics has multiple ADCs in ongoing clinical and preclinical development.
ADC Therapeutics is based in Lausanne (Biopôle), Switzerland and has operations in London, the San Francisco Bay Area and New Jersey. For more information, please visit https://adctherapeutics.com/ and follow the Company on Twitter and LinkedIn.
ZYNLONTA® is a registered trademark of ADC Therapeutics SA.
Use of Non-IFRS Financial Measures
In addition to financial information prepared in accordance with IFRS, this document also contains certain non-IFRS financial measures based on management’s view of performance including:
•Adjusted net loss
•Adjusted net loss per share
Management uses such measures internally when monitoring and evaluating our operational performance, generating future operating plans and making strategic decisions regarding the
allocation of capital. We believe that these adjusted financial measures provide useful information to investors and others in understanding and evaluating our operating results in the same manner as our management and facilitate operating performance comparability across both past and future reporting periods. These non-IFRS measures have limitations as financial measures and should be considered in addition to, and not in isolation or as a substitute for, the information prepared in accordance with IFRS. When preparing these supplemental non-IFRS measures, management typically excludes certain IFRS items that management does not believe are indicative of our ongoing operating performance. Furthermore, management does not consider these IFRS items to be normal, recurring cash operating expenses; however, these items may not meet the IFRS definition of unusual or non-recurring items. Since non-IFRS financial measures do not have standardized definitions and meanings, they may differ from the non-IFRS financial measures used by other companies, which reduces their usefulness as comparative financial measures. Because of these limitations, you should consider these adjusted financial measures alongside other IFRS financial measures.
The following items are excluded from adjusted net loss and adjusted net loss per share:
Shared-Based Compensation Expense: We exclude share-based compensation expense from our adjusted financial measures because share-based compensation expense, which is non-cash, fluctuates from period to period based on factors that are not within our control, such as our stock price on the dates share-based grants are issued. Share-based compensation expense has been, and will continue to be for the foreseeable future, a recurring expense in our business and an important part of our compensation strategy.
Certain Other Items: We exclude certain other significant items that we believe do not represent the performance of our business, from our adjusted financial measures. Such items are evaluated by management on an individual basis based on both quantitative and qualitative aspects of their nature. While not all-inclusive, examples of certain other significant items excluded from our adjusted financial measures would be: changes in the fair value of derivatives and the effective interest expense associated with the Facility Agreement with Deerfield, transaction costs associated with debt or equity issuances that are expenses pursuant to IFRS, and the effective interest expense and a cumulative catch-up adjustment associated with the deferred royalty obligation under the royalty purchase agreement with HealthCare Royalty Partners.
See the attached Reconciliation of IFRS Measures to Non-IFRS Measures for explanations of the amounts excluded and included to arrive at the non-IFRS financial measures.
Forward-Looking Statements
This press release contains statements that constitute forward-looking statements. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations and financial position, business and commercialization strategy, market opportunities, products and product candidates, research pipeline, ongoing and planned preclinical studies and clinical trials, regulatory submissions and approvals, 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. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including those described in our filings with the U.S. Securities and Exchange Commission. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this document speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any
change in events, conditions, or circumstances on which such statements are based unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
ADC Therapeutics SA
Condensed Consolidated Interim Statement of Operations (Unaudited)
(in KUSD except for share and per share data)
| For the Three Months Ended June 30, | For the Six Months Ended June 30, | |||||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||||||||||||
| Product revenues, net | 17,291 | 3,760 | 33,789 | 3,760 | ||||||||||||||||||||||
| License revenue | — | — | 30,000 | — | ||||||||||||||||||||||
| Total revenue | 17,291 | 3,760 | 63,789 | 3,760 | ||||||||||||||||||||||
| Operating expense | ||||||||||||||||||||||||||
| Cost of product sales | (2,266) | (121) | (2,795) | (121) | ||||||||||||||||||||||
| Research and development expenses | (48,537) | (39,533) | (97,489) | (78,705) | ||||||||||||||||||||||
| Selling and marketing expenses | (17,659) | (15,221) | (36,029) | (29,132) | ||||||||||||||||||||||
| General and administrative expenses | (18,240) | (19,367) | (37,251) | (36,949) | ||||||||||||||||||||||
| Total operating expense | (86,702) | (74,242) | (173,564) | (144,907) | ||||||||||||||||||||||
| Loss from operations | (69,411) | (70,482) | (109,775) | (141,147) | ||||||||||||||||||||||
| Other income (expense) | ||||||||||||||||||||||||||
| Financial income | 16 | 15 | 18,324 | 30 | ||||||||||||||||||||||
| Financial expense | (8,801) | (2,555) | (18,018) | (4,555) | ||||||||||||||||||||||
| Non-operating income (expense) | 12,875 | 693 | 26,317 | 21,923 | ||||||||||||||||||||||
| Total other income (expense) | 4,090 | (1,847) | 26,623 | 17,398 | ||||||||||||||||||||||
| Loss before taxes | (65,321) | (72,329) | (83,152) | (123,749) | ||||||||||||||||||||||
| Income tax benefit (expense) | 947 | (240) | 2,117 | (347) | ||||||||||||||||||||||
| Net loss | (64,374) | (72,569) | (81,035) | (124,096) | ||||||||||||||||||||||
| Net loss attributable to: | ||||||||||||||||||||||||||
| Owners of the parent | (64,374) | (72,569) | (81,035) | (124,096) | ||||||||||||||||||||||
| Net loss per share, basic and diluted | (0.84) | (0.95) | (1.05) | (1.62) | ||||||||||||||||||||||
ADC Therapeutics SA
Condensed Consolidated Interim Balance Sheet (Unaudited)
(in KUSD)
| June 30, 2022 | December 31, 2021 | |||||||||||||
| ASSETS | ||||||||||||||
| Current assets | ||||||||||||||
| Cash and cash equivalents | 376,778 | 466,544 | ||||||||||||
| Accounts receivable, net | 20,863 | 30,218 | ||||||||||||
| Inventory | 14,650 | 11,122 | ||||||||||||
| Other current assets | 12,151 | 17,298 | ||||||||||||
| Total current assets | 424,442 | 525,182 | ||||||||||||
| Non-current assets | ||||||||||||||
| Property, plant and equipment | 3,596 | 4,066 | ||||||||||||
| Right-of-use assets | 6,094 | 7,164 | ||||||||||||
| Intangible assets | 14,575 | 13,582 | ||||||||||||
| Interest in joint venture | 36,817 | 41,236 | ||||||||||||
| Deferred tax asset | 34,040 | 26,049 | ||||||||||||
| Other long-term assets | 899 | 693 | ||||||||||||
| Total non-current assets | 96,021 | 92,790 | ||||||||||||
| Total assets | 520,463 | 617,972 | ||||||||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||||||||
| Current liabilities | ||||||||||||||
| Accounts payable | 13,019 | 12,080 | ||||||||||||
| Other current liabilities | 52,384 | 50,497 | ||||||||||||
| Lease liabilities, short-term | 909 | 1,029 | ||||||||||||
| Current income tax payable | 799 | 3,754 | ||||||||||||
| Convertible loans, short-term | 6,573 | 6,575 | ||||||||||||
| Total current liabilities | 73,684 | 73,935 | ||||||||||||
| Non-current liabilities | ||||||||||||||
| Convertible loans, long-term | 89,844 | 87,153 | ||||||||||||
| Convertible loans, derivatives | 7,637 | 37,947 | ||||||||||||
| Deferred royalty obligation, long-term | 204,423 | 218,664 | ||||||||||||
| Deferred gain of joint venture | 23,539 | 23,539 | ||||||||||||
| Lease liabilities, long-term | 5,990 | 6,994 | ||||||||||||
| Defined benefit pension liabilities | — | 3,652 | ||||||||||||
| Total non-current liabilities | 331,433 | 377,949 | ||||||||||||
| Total liabilities | 405,117 | 451,884 | ||||||||||||
| Equity attributable to owners of the parent | ||||||||||||||
| Share capital | 6,445 | 6,445 | ||||||||||||
| Share premium | 981,818 | 981,827 | ||||||||||||
| Treasury shares | (119) | (128) | ||||||||||||
| Other reserves | 133,480 | 102,646 | ||||||||||||
| Cumulative translation adjustments | (358) | 183 | ||||||||||||
| Accumulated losses | (1,005,920) | (924,885) | ||||||||||||
| Total equity attributable to owners of the parent | 115,346 | 166,088 | ||||||||||||
| Total liabilities and equity | 520,463 | 617,972 | ||||||||||||
ADC Therapeutics SA
Reconciliation of IFRS Measures to Non-IFRS Measures (Unaudited)
(in KUSD except for share and per share data)
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
| in KUSD (except for share and per share data) | 2022 | 2021 | 2022 | 2021 | |||||||||||||||||||
| Net loss | (64,374) | (72,569) | (81,035) | (124,096) | |||||||||||||||||||
| Adjustments: | |||||||||||||||||||||||
| Share-based compensation expense (i) | 13,818 | 18,267 | 27,728 | 32,218 | |||||||||||||||||||
| Convertible loans, derivatives, change in fair value income (ii) | (14,455) | (2,053) | (30,310) | (23,222) | |||||||||||||||||||
| Convertible loans, first and second tranche, derivatives, transaction costs (iii) | — | 148 | — | 148 | |||||||||||||||||||
| Effective interest expense on convertible loans (iv) | 3,126 | 2,450 | 6,148 | 4,432 | |||||||||||||||||||
| Deferred royalty obligation interest expense (v) | 5,545 | — | 11,687 | — | |||||||||||||||||||
| Deferred royalty obligation cumulative catch-up adjustment income (v) | — | — | (18,288) | — | |||||||||||||||||||
| Adjusted net loss | (56,340) | (53,757) | (84,070) | (110,520) | |||||||||||||||||||
| Net loss per share, basic and diluted | (0.84) | (0.95) | (1.05) | (1.62) | |||||||||||||||||||
| Adjustment to net loss per share, basic and diluted | 0.11 | 0.25 | (0.04) | 0.18 | |||||||||||||||||||
| Adjusted net loss per share, basic and diluted | (0.73) | (0.70) | (1.09) | (1.44) | |||||||||||||||||||
| Weighted average shares outstanding, basic and diluted | 76,911,713 | 76,728,714 | 76,866,968 | 76,725,210 | |||||||||||||||||||
(i)Share-based compensation expense represents the cost of equity awards issued to our directors, management and employees. The fair value of awards is computed at the time the award is granted, including any market and other performance conditions, and is recognized over the vesting period of the award by a charge to the income statement and a corresponding increase in other reserves within equity. See note 15, “Share-based compensation” to the unaudited condensed consolidated interim financial statements. These accounting entries have no cash impact.
(ii)Change in the fair value of the convertible loan derivatives results from the valuation at the end of each accounting period of the derivatives associated with the convertible loans. See note 14, “Convertible loans” to the unaudited condensed consolidated interim financial statements. There are several inputs to these valuations, but those most likely to result in significant changes to the valuations are changes in the value of the underlying instrument (i.e., changes in the price of our common shares) and changes in expected volatility in that price. These accounting entries have no cash impact.
(iii)The transaction costs allocated to the convertible loan first and second tranche derivative represent actual costs. These are not expected to recur on an ongoing basis.
(iv)Effective interest expense on convertible loans relates to the increase in the value of our convertible loans in accordance with the effective interest method. See note 14, “Convertible loans” to the unaudited condensed consolidated interim financial statements.
(v)Deferred royalty obligation interest expense and cumulative catch-up adjustment relates to the accretion expense on our deferred royalty obligation pursuant to the royalty purchase agreement with HCR and changes in the expected payments to HCR based on a periodic assessment of our underlying
revenue projections. See note 16, “Deferred royalty obligation” to the unaudited condensed consolidated interim financial statements.
CONTACTS:
Investors
Eugenia Litz
Eugenia Litz
ADC Therapeutics
Eugenia.Litz@adctherapeutics.com
+44 7879 627205
Amanda Hamilton
ADC Therapeutics
ADC Therapeutics
amanda.hamilton@adctherapeutics.com
+1 917-288-7023
Media
Mary Ann Ondish
ADC Therapeutics
maryann.ondish@adctherapeutics.com
Mary Ann Ondish
ADC Therapeutics
maryann.ondish@adctherapeutics.com
+1 914-552-4625