ADC Therapeutics SA
For the period ended Jun 30, 2024. Filed Aug 6, 2024.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2024 · Filed Aug 6, 2024
Extracted filing text, with the paragraph anchors used by the comparison.
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Table of Contents
| PART I: FINANCIAL INFORMATION | 1 |
|---|---|
| Condensed Consolidated Balance Sheets (Unaudited) - June 30, 2024 and December 31, 2023 | 1 |
| Condensed Consolidated Statements of Operations (Unaudited) - Three and six months ended June 30, 2024 and 2023 | 2 |
| Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - Three and six months ended June 30, 2024 and 2023 | 3 |
| Condensed Consolidated Statements of Changes in Shareholders’ Equity (Deficit) (Unaudited) - Three and six months ended June 30, 2024 and 2023 | 4 |
| Condensed Consolidated Statements of Cash Flows (Unaudited) - Six months ended June 30, 2024 and 2023 | 6 |
| Notes to the Condensed Consolidated Financial Statements (Unaudited) | 7 |
| Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations | 22 |
| Item 3. Quantitative and Qualitative Disclosures About Market Risk | 37 |
| Item 4. Controls and Procedures | 37 |
| PART II: OTHER INFORMATION | 38 |
| Item 1. Legal Proceedings | 38 |
| Item 1A. Risk Factors | 38 |
| Item 2. Unregistered Sales of Equity Securities and Use of Proceeds | 38 |
| Item 3. Defaults Upon Senior Securities | 39 |
| Item 4. Mine Safety Disclosures | 39 |
| Item 5. Other Information | 39 |
| Item 6. Exhibits | 39 |
| Signatures | 40 |
Unless otherwise indicated or the context otherwise requires, all references in this Annual Report to “ADC Therapeutics,” “ADCT,” the “Company,” “we,” “our,” “ours,” “us” or similar terms refer to ADC Therapeutics SA and its consolidated subsidiaries.
FORWARD-LOOKING STATEMENTS
This Quarterly Report contains statements that constitute forward-looking statements. All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding our future catalysts, results of operations and financial position, business and commercial strategy, market opportunities, products and product candidates, research pipeline, ongoing and planned preclinical studies and clinical trials, regulatory submissions and approvals, research and development costs, projected revenues and expenses and the timing of revenues and expenses, timing and likelihood of success, as well as plans and objectives of management for future operations are forward-looking statements. Many of the forward-looking statements contained in this Quarterly Report can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate,” “will” and “potential,” among others.
Forward-looking statements are based on our management’s beliefs and assumptions and on information available to our management at the time such statements are made. Such statements are subject to known and unknown risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to:
the substantial net losses that we have incurred since our inception, our expectation to continue to incur losses for the foreseeable future and our need to raise additional capital to fund our operations and execute our business plan;
our indebtedness under the loan agreement and guaranty (the “Loan Agreement”) with certain affiliates and/or funds managed by each of Oaktree Capital Management, L.P. and Owl Rock Capital Advisors LLC, as lenders, and Blue Owl Opportunistic Master Fund I, L.P., as administrative agent, and the associated restrictive covenants thereunder;
the purchase and sale agreement (the “HCR Agreement”) with certain entities managed by HealthCare Royalty Management, LLC (“HCR”) and its negative effect on the amount of cash that we are able to generate from sales of, and licensing agreements involving, ZYNLONTA and on our attractiveness as an acquisition target;
our ability to complete clinical trials on expected timelines, if at all;
the timing, outcome and results of ongoing or planned clinical trials, whether the Company sponsored trials or through investigator initiated trials, and the sufficiency of such results;
undesirable side effects or adverse events of our products and product candidates;
our and our partners’ ability to obtain and maintain regulatory approval for our product and product candidates;
our and our partners’ ability to successfully commercialize our products;
the availability and scope of coverage and reimbursement for our products;
the complexity and difficulty of manufacturing our products and product candidates;
the substantial competition in our industry, including new technologies and therapies;
the timing and results of any early research projects and future clinical outcomes;
our reliance on third parties for preclinical studies and clinical trials and for the manufacture, production, storage and distribution of our products and product candidates and certain commercialization activities for our products;
our ability to obtain, maintain and protect our intellectual property rights and our ability to operate our business without infringing on the intellectual property rights of others;
our estimates regarding future revenue, expenses and needs for additional financing;
the size and growth potential of the markets for our products and product candidates potential product liability lawsuits and product recalls;
our ability to identify and successfully enter into strategic collaborations for research or licensing opportunities in the future;
and those identified in the “Item 1A. Risk Factors” section contained in this Quarterly Report and our Annual Report on Form 10-K, and in our other reports filed with the U.S. Securities and Exchange Commission (the “SEC”), from time to time thereafter.
Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise.
In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.