ADC Therapeutics Reports Second Quarter 2026 Financial Results and Provides Operational Updates
ADC Therapeutics Reports Second Quarter 2026 Financial Results and Provides Operational Updates |
| [13-August-2026] |
Second quarter 2026 net product revenue of $18.6 million; cash and cash equivalents of $219.1 million as of June 30, 2026 LOTIS-7, LOTIS-5 and MZL IIT data submitted for presentation at ASH Company evaluating regulatory path for ZYNLONTA® to obtain full approval and advance into earlier lines of DLBCL following LOTIS-5 pre-sBLA meeting Company to host conference call today at 8:30 a.m. EDT LAUSANNE, Switzerland, Aug. 13, 2026 /PRNewswire/ -- ADC Therapeutics SA (NYSE: ADCT) today reported financial results for the second quarter ended June 30, 2026, and provided recent operational updates.
ZYNLONTA® commercial performance as a monotherapy in 3L+ diffuse large B-cell lymphoma (DLBCL) in the second quarter of 2026 continued to be broadly in line with recent quarters. Abstracts for LOTIS-5, LOTIS-7 and MZL IIT data have all been submitted to the 68th American Society of Hematology (ASH) Annual Meeting and Exposition and will be submitted for publication as well as potential compendia inclusion. The Company anticipates growth starting in 2027. Recently, the Company held a pre-supplemental Biologics License Application (sBLA) meeting with the U.S. Food and Drug Administration (FDA), during which the LOTIS-5 data was discussed. Following FDA meeting feedback regarding the benefit-risk observed in the LOTIS-5 trial, the Company is assessing the best regulatory path forward. Beyond this, enrollment in LOTIS-7 is now complete, and these data support the Company's belief that ZYNLONTA plus glofitamab demonstrates the most compelling combination data generated to date in 2L+ DLBCL with a safety profile generally consistent with prior LOTIS-7 disclosures. Based on this potentially practice-changing LOTIS-7 data, the Company is assessing a Phase 3 trial for the combination of ZYNLONTA plus glofitamab. As the Company continues to commercialize ZYNLONTA in the 3L+ DLBCL setting, we will work closely with the FDA to determine how to best obtain full approval and to advance ZYNLONTA combinations into earlier lines of therapy in DLBCL. "We are pleased by our second quarter performance, which reflects continued commercial momentum and strong operational discipline through ongoing cost reduction efforts. Over the course of this year, we have released LOTIS-5 data and completed the LOTIS-7 trial. With these data now in hand, we believe that ZYNLONTA plus glofitamab offers an opportunity to take a leading second-line plus position, in the context of the evolving competitive landscape, solidifying ZYNLONTA as a foundational therapy in DLBCL," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "Additionally, following the FDA pre-sBLA meeting for the LOTIS-5 trial, we are assessing regulatory approaches to determine the best path forward." "As we work to advance ZYNLONTA into earlier lines of DLBCL, we remain confident that ZYNLONTA will continue to play a meaningful role for patients with B-cell malignancies, in the 3L+ DLBCL setting, and through potential compendia inclusion starting in 2027," said Mohamed Zaki, M.D., Ph.D., Chief Medical Officer of ADC Therapeutics. "We look forward to the presentation of the LOTIS-5, LOTIS-7 and MZL investigator-initiated trial data later this year and expect submission for publication. In addition, we expect to submit LOTIS-7 and MZL data to the FDA for Breakthrough Designation." Second Quarter 2026 Operational Updates and Upcoming Milestones LOTIS-5 pre-sBLA meeting held; Company evaluating regulatory path forward. In June 2026, the Company announced topline results from the LOTIS-5 Phase 3 confirmatory trial of ZYNLONTA in combination with rituximab, which met the trial's primary endpoint of progression-free survival (PFS). The Company submitted full data to ASH. The Company recently held a pre-sBLA meeting with the FDA. During this meeting, the FDA noted substantial concerns regarding the benefit-risk or verification of clinical benefit observed in this trial based on the imbalance in Grade 5 events, when assessed in the context of a marginal treatment benefit. Following this meeting, the Company is assessing the best regulatory path forward and plans to provide an update on regulatory strategy and timing in the near future. ZYNLONTA remains available under accelerated approval as a monotherapy in 3L+ DLBCL and the Company plans to continue to commercialize in this setting. LOTIS-7 trial completed enrollment. The LOTIS-7 Phase 1b trial evaluating ZYNLONTA in combination with the bispecific antibody glofitamab (COLUMVI®) in patients with r/r DLBCL completed enrollment of 100 patients at the selected 150 µg/kg starting dose of ZYNLONTA. Of note, consistent with other glofitamab trials, the protocol for LOTIS-7 recommends prophylaxis (including vaccinations) for viral, fungal, and bacterial infections (including PJP and herpesvirus), which was not a part of the LOTIS-5 protocol. The Company submitted LOTIS-7 data to ASH, which continues to demonstrate potential best-in-class bispecific combination data with a safety profile generally consistent with prior LOTIS-7 disclosures. The Company is preparing to submit the complete trial results for publication, which will then be submitted to compendia. The Company is also evaluating a regulatory pathway for this combination and plans to submit for Breakthrough Therapy designation (BTD) this year. Announced strategic reorganization to support ZYNLONTA growth opportunities and regulatory priorities. ADC Therapeutics implemented an approximately 17 percent workforce reduction globally and estimates that the reorganization will generate annualized estimated cost savings of approximately $10 million. The reduction is driven by the expected completion of the LOTIS-5 and LOTIS-7 trials this year, as well as operational efficiencies. With these changes, the Company is resourced to deliver on its key clinical, regulatory, and manufacturing activities while maintaining its full externally facing medical affairs and commercial footprint to support ZYNLONTA. Investigator-Initiated trials (IITs) evaluating ZYNLONTA in additional B-cell malignancies continue to advance. The University of Miami Sylvester Comprehensive Cancer Center-led multi-center Phase 2 trials of ZYNLONTA in combination with rituximab to treat r/r follicular lymphoma (FL) and ZYNLONTA as a monotherapy to treat marginal zone lymphoma (MZL) are ongoing. Updated MZL data were submitted to ASH and the Company anticipates presentation of this data before the end of the year, with publication and compendia submission to follow. The Company also anticipates presentation of updated FL data in Q2 2027. The Company intends to assess potential regulatory pathways and plans to submit for BTD for MZL. Second Quarter 2026 Financial Results Product Revenues: Net product revenues were $18.6 million and $38.7 million for the second quarter and six months ended June 30, 2026, as compared to $18.1 million and $35.5 million for the same periods in 2025. The quarter-over-quarter increase was driven by higher price. The increase for the six-month period was primarily driven by volume increase, which reflects the normal variability in customer ordering patterns, as well as higher price. License Revenues and Royalties: License revenue and royalties were $0.6 million for the second quarter and $1.4 million for the six months ended June 30, 2026, as compared to $0.8 million and $6.4 million for the same periods in 2025. The decrease for the six-month period was primarily driven by a prior-year milestone received from our partner. Cost of Product Sales: Cost of product sales was $2.3 million and $6.0 million for the second quarter and six months ended June 30, 2026, as compared to $0.8 million and $2.9 million for the same periods in 2025. The increase in cost of product sales was primarily attributable to a $1.1 million increase for the second quarter and a $2.5 million increase for the six-month period in certain personnel costs. This reflects a change in focus of these personnel from research and development clinical supply activities to commercial manufacturing activities. Research and Development (R&D) Expense: R&D expense was $17.4 million and $37.2 million for the second quarter and six months ended June 30, 2026, as compared to $30.1 million and $59.0 million for the same periods in 2025. The decrease in R&D costs was primarily driven by a reduction in spending on discontinued programs and completion of the IND-enabling activities for our PSMA-targeting ADC. The decrease was also driven by a shift of certain personnel costs totaling $1.7 million for the quarter and $3.8 million for the six-month period to cost of product sales ($1.1 million QoQ/$2.3 million YoY), inventory capitalization, and selling and marketing expense, reflecting a change in focus of these personnel from research and development activities toward commercial manufacturing and fulfillment activities. Selling and Marketing (S&M) Expense: S&M expense was $12.6 million and $25.3 million for the second quarter and six months ended June 30, 2026, as compared to $10.1 million and $20.7 million for the same periods in 2025. The increase period-over-period was primarily due to higher marketing and advertising expenses and higher wages and benefits. General & Administrative (G&A) Expense: G&A expense was $9.7 million and $19.6 million for the second quarter and six months ended June 30, 2026, as compared to $8.8 million and $18.8 million for the same periods in 2025. The increase period-over-period was primarily due to increased professional and IT expenses, partially offset by lower wages and benefits. Restructuring, impairment and other related costs: In connection with the strategic reorganization and workforce reduction announced in June 2026, we incurred employee severance and related benefit costs of $2.7 million for the second quarter and six months ended June 30, 2026. In connection with the strategic reprioritization and restructuring plan announced in June 2025, we incurred $13.1 million in restructuring and impairment costs for the second quarter and six months ended June 30, 2025, which consisted of $6.7 million in employee severance and related benefit costs, and $6.4 million in non-cash impairment of assets in connection with the close down of the UK facility. Total Operating Expenses and Adjusted Total Operating Expenses: Total operating expenses were $44.7 million and $90.8 million for the second quarter and six months ended June 30, 2026, as compared to $63.0 million and $114.5 million for the same periods in 2025, a reduction of 29% and 21%, respectively. On a non-GAAP basis, total adjusted operating expenses were $37.2 million and $80.1 million for the second quarter and six months ended June 30, 2026, as compared to $47.8 million and $96.9 million for the same periods in 2025, a reduction of 22% and 17.3%, respectively. The reduction in total adjusted operating expenses was primarily driven by lower R&D expenses. Net Loss and Adjusted Net Loss: Net loss for the second quarter and six months ended June 30, 2026, was $16.6 million or $49.5 million, or a net loss of $0.11 and $0.32 per basic and diluted share, as compared to a net loss of $56.6 million and $95.2 million, or a net loss of $0.50 and $0.86 per basic and diluted share, for the same periods in 2025. On a non-GAAP basis, adjusted net loss for the second quarter and six months ended June 30, 2026, was $16.3 million or $36.0 million, or a net loss of $0.11 and $0.23 per basic and diluted share, as compared to a net loss of $28.7 million and $52.6 million, or a net loss of $0.25 and $0.48 per basic and diluted share, for the same periods in 2025. The lower net loss and adjusted net loss were primarily due to lower operating expenses, and on a per basic and diluted share basis, by a higher number of weighted average shares outstanding. Net loss was also favorably impacted by the change in fair value of warrants and the cumulative catch-up adjustment of the Company's deferred royalty obligation. Cash and Cash Equivalents: As of June 30, 2026, cash and cash equivalents were $219.1 million, compared to $261.3 million as of December 31, 2025, a change primarily driven by cash used in operations. The Company has an expected cash runway at least into 2028. Conference Call Details ADC Therapeutics management will host a conference call and live audio webcast to discuss first quarter 2026 financial results and provide a company update today at 8:30 a.m. EDT. 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 & Presentations" in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call. About ADC Therapeutics ADC Therapeutics' CD19-directed ADC ZYNLONTA received accelerated approval by the FDA and conditional approval from the European Commission 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 and in earlier lines of therapy. Headquartered in Lausanne (Biopôle), Switzerland, with operations in New Jersey, ADC Therapeutics is focused on driving innovation in ADC development with specialized capabilities from clinical to manufacturing and commercialization. Learn more at adctherapeutics.com and follow us on LinkedIn. Use of Non-GAAP Financial Measures In addition to financial information prepared in accordance with U.S. Generally Accepted Accounting Principles (GAAP), this document also contains certain non-GAAP financial measures based on management's view of performance including: Adjusted total operating expenses 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-GAAP 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 GAAP. When preparing these supplemental non-GAAP measures, management typically excludes certain GAAP items that management does not believe are indicative of our ongoing operating performance. Furthermore, management does not consider these GAAP items to be normal, recurring cash operating expenses; however, these items may not meet the GAAP definition of unusual or non-recurring items. Since non-GAAP financial measures do not have standardized definitions and meanings, they may differ from the non-GAAP 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 GAAP financial measures. The following items are excluded from adjusted total operating expenses: Share-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. Restructuring, Impairment and Other Related Costs: We exclude from our adjusted financial measures costs associated with our execution of certain strategies and initiatives to streamline operations, achieve targeted cost reductions or reprioritize research and development activities. These costs may include employee severance, contract termination costs, facility closing and exit costs, asset impairment charges (which are non-cash) and other costs that we believe do not represent the performance of our business or have a direct correlation to our ongoing or future business operations. The following items are excluded from adjusted net loss and adjusted net loss per share: Share-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: restructuring, impairment and other related costs, changes in the fair value of warrant obligations and the effective interest expense associated with the senior secured term loan facility and the effective interest expense and cumulative catch-up adjustments associated with the deferred royalty obligation under the royalty purchase agreement with HealthCare Royalty Partners. See the attached Reconciliation of GAAP Measures to Non-GAAP Measures for explanations of the amounts excluded and included to arrive at the non-GAAP financial measures. About ZYNLONTA® The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have 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 and in the European Union under conditional 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. Please see full prescribing information including important safety information about ZYNLONTA at www.ZYNLONTA.com. ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy. Forward-Looking Statements
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SOURCE ADC Therapeutics SA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Company Codes: NYSE:ADCT | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||












