You should refer to the company's second quarter earnings release for information and reconciliation of historical non-GAAP measures with the comparable GAAP financial measures. These changes are expected to help position our company for long-term growth with significantly reduced operating expenses. With LOTIS-7, we estimate we can expand the total opportunity for ZYNLONTA in DLBCL to $500 million-$800 million in peak revenue with regulatory approval and Compendia listing.

We believe the indolent lymphomas opportunity could provide additional peak revenue of $100 million-$200 million with regulatory approval and Compendia listing, primarily driven by MZL. The first half net product revenue was $35.5 million compared to $34.9 million during the first half of 2024. The increase in net loss for the quarter is primarily attributable to one-time restructuring and impairment costs and higher R&D expenses.

First, can you walk us through your Salesforce growth plan and timeline as you expect to unlock a much larger TAM with the strong response data outcomes of the LOTIS trial?

What went well
  • Net product revenues of ZYNLONTA were $18.1 million in the second quarter and $35.5 million in the first half, both slightly higher than the prior-year periods, showing the drug maintained its place as a treatment option for third-line-plus DLBCL despite the entry of the bispecific class.
  • LOTIS-7 data (ZYNLONTA plus glofitamab) presented at EHA and ICML showed an overall response rate of 93.3% and a complete response rate of 86.7% across 30 efficacy-evaluable large B-cell lymphoma patients, with 25 of 26 complete responders remaining in CR at the April 2025 cutoff versus a 47%-62% CR benchmark for other bispecific combinations.
  • The company completed a $100 million private placement, extending its expected cash runway into 2028; cash and equivalents rose to $264.6 million at June 30 from $194.7 million at March 31.
  • A strategic reprioritization focused resources on ZYNLONTA and the preclinical PSMA-targeting ADC, discontinuing other solid-tumor preclinical programs and planning to shut the U.K. facility and reduce the global workforce by roughly 30%, positioning the company for significantly reduced operating expenses.
  • LOTIS-5 enrollment was completed and remained on track to reach the pre-specified number of progression-free survival events by year-end; the safety lead-in had shown an 80% ORR and 50% CR with no new safety signals.
  • The Phase II marginal zone lymphoma investigator-initiated trial showed an 85% ORR and 69% CR, supporting the indolent-lymphoma expansion thesis.
What went wrong
  • GAAP net loss widened to $56.6 million ($0.50 per share) from $36.5 million ($0.38) a year earlier, driven by $13.1 million of restructuring and impairment costs ($6.7 million severance plus $6.4 million non-cash impairment tied to the U.K. facility closure) and higher R&D.
  • Non-GAAP total operating expenses rose about 8% year over year to $47.8 million, primarily on higher R&D for LOTIS-5, LOTIS-7 and PSMA IND-enabling activities.
  • Roche's receipt of a complete response letter for glofitamab (the STARGLO study) in second-line DLBCL introduced uncertainty into the 2L bispecific landscape, prompting analyst questions about read-through to ADC's own program.
  • The core third-line-plus monotherapy remains a mature, roughly $70 million annual run-rate business with limited near-term growth until label expansion is achieved.

Guidance Changes

MetricPeriodCurrent guidance
Cash runwayForwardExtended into 2028 following the $100 million private placement
LOTIS-5 confirmatory readoutH1 2026Top-line data to follow; sBLA submission anticipated in H1 2026 and potential approval in H1 2027
LOTIS-7 next updateH2 2025Expansion to 100 patients at 150 ug/kg; additional data update in H2 2025 and FDA engagement
PSMA-targeting ADCEnd of 2025On track to complete IND-enabling activities by year-end
ZYNLONTA U.S. peak revenue frameworkLong-termLOTIS-5 $200-300M; total DLBCL with LOTIS-7 $500-800M; indolent lymphomas $100-200M; combined $600M-$1B, each assuming approval and compendia listing

Performance Breakdown

MetricYoYNote
Net product revenue +6.5% (to $18.1M from $17.0M) Stable third-line-plus DLBCL demand as ZYNLONTA held its market position against bispecifics.
First-half net product revenue +1.7% (to $35.5M from $34.9M) Broadly flat underlying demand in the approved monotherapy indication.
GAAP net loss Widened to $56.6M / $0.50 (from $36.5M / $0.38) One-time restructuring and impairment charges of $13.1M plus higher R&D spend.
Non-GAAP operating expenses +8% (to $47.8M) Higher R&D on LOTIS-5, LOTIS-7 and PSMA IND-enabling activities.
Cash and equivalents $264.6M (up from $194.7M at Mar 31) Net proceeds from the $100 million private placement, partly offset by operating cash use.

Earnings Call Themes & Trends

TopicPrevious mentionCurrent periodTrend
Balance sheet and cost resetFunding constraints$100M PIPE plus a ~30% workforce reduction and U.K. site closure reset the cost base and pushed cash runway into 2028.—
LOTIS-7 combination potentialEarly combination data93.3% ORR / 86.7% CR positions ZYNLONTA plus glofitamab as a potential best-in-class combination among complex therapies in 2L+ DLBCL.—
DLBCL market segmentationNew frameworkTwo segments: complex therapies (CAR-T, transplant, bispecifics) versus broadly accessible therapies (ADCs, mAbs, chemo); estimated 60/40 split in 3L+ and ~25/75 in 2L.—
Peak revenue opportunityIntroducedManagement framed a $600M-$1B U.S. peak revenue opportunity across LOTIS-5, LOTIS-7 and indolent lymphomas.—
Pipeline beyond ZYNLONTARefocusedPreclinical PSMA-targeting ADC advanced toward IND while other solid-tumor programs were discontinued.—

Q&A Summary

Michael Schmidt (Guggenheim) asked how Roche's glofitamab complete response letter (STARGLO) could affect the 2L DLBCL market and ADC's trial collaboration, and how mature overall survival would be for LOTIS-5 by year-end.
Management said it could not comment on the specifics of Roche's CRL but remained confident in the unmet need in 2L+ DLBCL and in LOTIS-5's design (a large, 1:1 randomized 420-patient study with lower Asia enrollment than STARGLO and an encouraging safety run-in); it added that OS maturity at the final PFS analysis was hard to predict and would be clearer at readout.
Eric Schmidt (Cantor) asked what ADC hopes to learn from its FDA discussions on LOTIS-7 and how/where it would disclose the next LOTIS-7 data.
Management said it is expanding LOTIS-7 to 100 patients at 150 ug/kg, pursuing a publication and compendia strategy, and will engage the FDA on potential paths (2L or front line) as data mature; it had not decided whether the next update would be a corporate announcement or a medical congress, weighing the ability to show a more robust dataset.
Leonid Timashev (RBC) asked how ZYNLONTA fits into indolent lymphomas and the bar for NCCN inclusion in marginal zone and follicular lymphoma.
Management said the ~50-patient MZL trial should be sufficient (the last NCCN-added agent, pirtobrutinib, was based on 36 patients), that a 40%+ CR rate would be a meaningful improvement over the ~29% standard of care, and that strong single-agent efficacy and tolerability mean it does not currently see a need to add a bispecific in that setting.
Sudan Loganathan (Stephens) asked about the sales-force growth plan, any commercial collaboration with Roche, and LOTIS-5's role in the 2L landscape.
Management said its field force already covers ~90% of the DLBCL opportunity and would add incremental commercial and medical resources ahead of launch; there is no planned commercial or medical collaboration with Roche, and it will not promote LOTIS-7 off-label (compendia first), while LOTIS-5 remains central to the broadly accessible segment.

More on ADC Therapeutics SA

Reported 2025-08-12 · figures from the ADC Therapeutics SA Q2 2025 earnings call.

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