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    ADCT
    Earnings call· Jun 2026(Q2 FY26)

    ADC Therapeutics SA Q2 FY26 earnings call ADCT

    Aug 13, 2026 Source

    Executive summary

    ADC Therapeutics Q2 FY26 — ZYNLONTA Performance and Pipeline Updates

    ADC Therapeutics reported consistent commercial performance for ZYNLONTA monotherapy in Q2 FY26, while navigating regulatory uncertainty for its LOTIS-5 trial due to FDA concerns. The company is actively pursuing a breakthrough designation and assessing a Phase III trial for its LOTIS-7 combination, which showed compelling data. A strategic reorganization is expected to yield significant cost savings, supporting a healthy cash runway into 2028.

    Highlights

    5

    • ZYNLONTA net product revenues were $18.6 million in Q2 FY26, broadly in line with recent quarters.

    • LOTIS-7 completed enrollment of 100 patients at the selected dose level of ZYNLONTA plus glofitamab.

    • LOTIS-7 data submitted to ASH demonstrates compelling combination data with a safety profile generally consistent with prior disclosures.

    • Strategic reorganization implemented in June resulted in annualized cost savings of approximately $10 million.

    • Ended Q2 FY26 with a healthy cash balance of $219.1 million, maintaining cash runway at least into 2028.

    Concerns

    2

    • FDA noted substantial concerns regarding the benefit-risk or verification of clinical benefit observed in the LOTIS-5 trial, leading to an assessment of the regulatory path forward.

    • The second quarter of 2026 included a one-time expense related to the strategic reorganization.

    Guidance & targets

    6
    CategoryTargetConfidence
    Cash runway
    At least into 2028
    high materiality
    High
    LOTIS-7 Breakthrough Designation submission
    Submit for breakthrough designation
    high materiality
    High
    MZL Breakthrough Designation submission
    Submit for breakthrough designation
    medium materiality
    High
    LOTIS-5 Compendia inclusion
    Potential compendia inclusion
    medium materiality
    Medium
    LOTIS-7 Compendia inclusion
    Potential compendia inclusion
    medium materiality
    Medium
    Follicular Lymphoma (FL) data presentation
    Anticipated in the second quarter of 2027
    medium materiality
    High

    Segment performance

    1
    SegmentRevenueYoYQoQMargin
    ZYNLONTA Monotherapy (Third-line plus DLBCL)
    Commercial performance continued to be broadly in line with recent quarters, demonstrating a well-established profile of rapid, deep, and durable efficacy with manageable safety. No impact on sales observed from LOTIS-5 disclosure.
    Net product revenues: $18.6 millionNet product revenues (Q2 2025): $18.1 millionPatients treated in U.S. since 2021: ~5,000
    		$18.6M———

    Operational metrics

    14
    ZYNLONTA Net Product Revenues
    $18.6Mvs $18.1M in Q2 FY25
    Q2 FY26

    Commercial performance continued to be broadly in line with recent quarters.

    Cost of Product Sales
    $2.3Mvs $0.8M in Q2 FY25
    Q2 FY26

    Increase primarily driven by a change in focus of personnel from R&D clinical supply activities to commercial manufacturing activities.

    Cost of Product Sales (6 months YTD)
    $6Mvs $2.9M for same period in 2025
    6 months ended June 30, 2026

    Increase primarily driven by a change in focus of personnel from R&D clinical supply activities to commercial manufacturing activities.

    Total Operating Expenses (GAAP)
    $44.7M
    Q2 FY26

    Includes a one-time expense related to strategic reorganization.

    Total Adjusted Operating Expenses (non-GAAP)
    $37.2Mdown 22% over prior year
    Q2 FY26

    Primarily driven by lower R&D expenses.

    Annualized Cost Savings
    $10M
    Annualized

    Resulting from strategic reorganization and workforce reduction of approximately 17%.

    Net Loss (GAAP)
    $16.6Mvs $56.6M in Q2 FY25
    Q2 FY26

    Q2 FY26 included a one-time expense related to reorganization; Q2 FY25 included restructuring, impairment, and related costs.

    Adjusted Net Loss (non-GAAP)
    $16.3Mvs $28.7M in Q2 FY25
    Q2 FY26

    Lower net loss primarily due to lower operating expenses.

    Cash and Cash Equivalents
    $219.1Mvs $231M as of March 31, 2026
    As of June 30, 2026

    Change primarily driven by cash used in operations.

    Patients treated with ZYNLONTA (U.S.)
    ~5,000
    Since FDA accelerated approval in 2021

    Refers to ZYNLONTA monotherapy in the third-line plus DLBCL setting.

    LOTIS-7 Patient Enrollment
    100
    Completed enrollment

    Enrollment completed for the Phase Ib trial combining ZYNLONTA with glofitamab in second-line plus DLBCL patients.

    Workforce Reduction
    17%
    June 2026

    Part of a strategic reorganization to achieve operational efficiencies and cost savings.

    LOTIS-7 Grade 5 Events (prior disclosure)
    ~4%
    Prior disclosure (December)

    Refers to the last disclosure on 49 patients, indicating a low percentage of Grade 5 events.

    LOTIS-5 Grade 5 Infections Type
    —
    LOTIS-5 trial

    The primary type of infections observed in LOTIS-5 were bacterial, which prophylaxis could play a role in mitigating.

    Industry KPIs

    5
    MetricValueDetails
    Pipeline read out calendarLOTIS-5, LOTIS-7, MZL data submitted for presentation at ASH; FL data anticipated Q2 2027
    Product franchise net sales$18.6MUSD
    Regulatory approvals filingsLOTIS-5 pre-sBLA meeting with FDA; LOTIS-7 breakthrough designation submission planned; MZL breakthrough designation expected
    Clinical trial efficacy safety dataLOTIS-5 met primary endpoint of progression-free survival; LOTIS-7 demonstrates compelling combination data with consistent safety
    Cumulative patients uptake since launch~5,000patients

    Risks & headwinds

    2
    FDA concerns regarding LOTIS-5 benefit-riskOngoing

    Substantial concerns noted by FDA

    Mitigation: Assessing regulatory path forward, including additional data, risk management options, or modifications to potential label.

    One-time expense related to strategic reorganizationQ2 FY26

    Included in Q2 FY26 GAAP net loss

    Mitigation: Strategic reorganization implemented to achieve annualized cost savings of approximately $10 million.

    What to watch in Q3 FY26

    5

    LOTIS-5 regulatory path update

    Future update
    CurrentAssessing path forward after FDA concerns
    TargetClear regulatory strategy and timing

    Why it matters

    Determines the future of ZYNLONTA's full approval in second-line DLBCL.

    We plan to provide an update on regulatory strategy and timing in the future.

    Q&A highlights

    5

    Given the FDA's concerns on LOTIS-5, was there any discussion about maintaining the accelerated approval status for ZYNLONTA monotherapy?

    The FDA's discussions and concerns were solely related to the LOTIS-5 trial (ZYNLONTA in combination), not the single-agent ZYNLONTA. The company remains confident in the monotherapy's accelerated approval status and is committed to working with the FDA for full approval.

    “So there was no feedback at all about the single agent. So we remain confident that the monotherapy will stay on the market. We'll continue to have accelerated approval.”

    asked by Eric Schmidt · answered by Ameet Mallik

    2 min read5 chapters

    Detailed Narrative

    01

    ZYNLONTA Commercial Performance

    ZYNLONTA's commercial performance in Q2 FY26 remained broadly in line with recent quarters, with net product revenues of $18.6 million. The company remains confident in ZYNLONTA's role as a differentiated single-agent treatment option for third-line plus DLBCL patients. Since its FDA accelerated approval in 2021, ZYNLONTA monotherapy has been used to treat approximately 5,000 patients in the U.S., establishing its profile of rapid, deep, and durable efficacy with manageable safety.

    02

    LOTIS-5 Regulatory Path Forward

    The Phase III confirmatory study, LOTIS-5, met its primary endpoint of progression-free survival. However, following a pre-sBLA meeting in early August, the FDA expressed substantial concerns regarding the benefit-risk or verification of clinical benefit observed in the trial. ADC Therapeutics is now assessing the regulatory path forward, considering additional data, risk management options, or modifications to the potential label to address FDA concerns. The full LOTIS-5 data has been submitted for presentation at ASH and is being prepared for publication and compendia submission.

    03

    LOTIS-7 Data and Future Potential

    Enrollment for the Phase Ib LOTIS-7 trial, combining ZYNLONTA with glofitamab in second-line plus DLBCL patients, was completed with 100 patients at the 150 micrograms per kg dose. The company believes the data demonstrates compelling combination efficacy with a safety profile consistent with prior disclosures, noting the protocol included prophylaxis measures not present in LOTIS-5. The data has been submitted to ASH, and the company plans to submit for breakthrough designation this year and is assessing a Phase III trial to position ZYNLONTA plus glofitamab as a leading second-line therapy.

    04

    Indolent Lymphoma Pipeline Progress

    For multicenter investigator-initiated trials of ZYNLONTA in indolent lymphomas, updated marginal zone lymphoma (MZL) data was submitted to ASH, with publication and compendia submission to follow. The company expects to submit for breakthrough designation for MZL. Updated follicular lymphoma (FL) data is anticipated in Q2 2027, also with plans for publication and compendia submission.

    05

    Strategic Reorganization and Financial Position

    In June, ADC Therapeutics announced a strategic reorganization, including a workforce reduction of approximately 17% and other operational efficiencies. These changes are expected to result in annualized cost savings of approximately $10 million, while maintaining the necessary resources for clinical, regulatory, manufacturing, and commercial activities. The company ended Q2 FY26 with a cash and cash equivalents balance of $219.1 million, providing an expected cash runway at least into 2028.

    AI-generated summary of the company’s earnings call. Not investment advice.