You should refer to the company's third quarter earnings release for information and reconciliation of historical non-GAAP measures to the corporate GAAP financial measures. We believe LOTIS-5 has the potential to lift peak annual revenue for ZYNLONTA to $200-$300 million as we expand into the second-line setting. With LOTIS-7, we estimate we can expand the total opportunity for ZYNLONTA in DLBCL to $500-$800 million in peak annual revenue with both regulatory approval and compendia listing. The first segment includes complex therapies which require unique infrastructure and expertise to handle logistical requirements and patient management.

The second segment comprises more broadly accessible therapies which all physicians can administer in the outpatient setting and includes ADCs, monoclonal antibodies, and chemotherapy. We continue to be disciplined in our capital allocation towards potential value creation while driving efficiencies across the portfolio. Could you also give some qualitative comments on the pace of revenue ramp-up once you have those potentially positive data or approval in hand? I think you were asking about the milestones and then also the revenue inflection.

If you think of the revenue ramp-up for those two following compendia inclusion and approvals, which we expect for both the first half of 2027, we expect revenues to ramp up subsequent to that. Obviously, we're hoping with efficacy improvements, you actually gain share, and that's what leads to the guidance of $200 million-$300 million.

What went well
  • Updated Phase II follicular lymphoma investigator-initiated trial data (ZYNLONTA plus rituximab) presented at the 22nd International Workshop on Non-Hodgkin Lymphoma showed a 98.2% overall response rate and an 83.6% complete response rate across 55 efficacy-evaluable patients, with median PFS not reached after 28 months and a 93.9% 12-month PFS.
  • The company secured a $60 million private placement in October led by TCGX with participation from Redmile Group and existing investors, taking pro forma cash to roughly $292.3 million and reinforcing a cash runway at least into 2028.
  • Non-GAAP total operating expenses fell 12.1% year over year to $45 million on lower R&D, with sales and marketing spend stable, reflecting disciplined capital allocation.
  • GAAP net loss narrowed to $41 million ($0.30 per share) from $44 million ($0.42) a year earlier on lower R&D and G&A expenses.
  • ZYNLONTA held its established share in third-line-plus DLBCL despite a more competitive environment, and PSMA-targeting ADC IND-enabling activities remained on track for year-end completion.
What went wrong
  • Net product revenue declined to $15.8 million from $18 million a year earlier, reflecting variability in customer ordering patterns and marking one of the softest quarters of the past two years.
  • The approved third-line-plus indication remained essentially flat, with the meaningful revenue inflection dependent on LOTIS-5 approval not expected until 2027.

Guidance Changes

MetricPeriodCurrent guidance
LOTIS-7 updateBefore end of 2025Clinical update on all efficacy-evaluable patients with a minimum six months of follow-up via a corporate announcement; enrollment to ~100 accelerating post-EHA/ICML
LOTIS-5 confirmatory readoutH1 2026Top-line data in H1 2026; sBLA, potential approval and compendia inclusion in H1 2027
Indolent lymphoma programsEnd 2026 - mid 2027Additional conference data by lead investigators; regulatory and compendia strategies to be assessed
Cash runwayForwardAt least to 2028, reinforced by the $60 million October financing
ZYNLONTA U.S. peak revenue frameworkLong-termReaffirmed: LOTIS-5 $200-300M, total DLBCL $500-800M, indolent lymphomas $100-200M

Performance Breakdown

MetricYoYNote
Net product revenue -12.2% (to $15.8M from $18.0M) Variability in customer ordering patterns; broadly in line with the two-year quarterly run rate despite a soft print.
Non-GAAP operating expenses -12.1% (to $45M) Lower R&D expense with stable sales and marketing spend.
GAAP net loss Narrowed to $41M / $0.30 (from $44M / $0.42) Lower R&D and G&A expenses.
Cash and equivalents $234.7M (pro forma ~$292.3M) $60 million October private placement lifted pro forma cash; compares with $250.9M at Dec 31, 2024.

Earnings Call Themes & Trends

TopicPrevious mentionCurrent periodTrend
Indolent lymphoma expansionMZL and FL IITsFollicular lymphoma IIT delivered a 98.2% ORR / 83.6% CR; management sees MZL as higher unmet need with less competition and FL as more competitive.—
Balance sheet strength$100M June PIPEAdded a $60M October PIPE (TCGX/Redmile) for pro forma cash of ~$292.3M and a runway at least to 2028.—
Cost disciplineRestructuring completedNon-GAAP opex down 12.1% year over year with a leaner cost base after the H2 reprioritization.—
Revenue variabilityQuarter-to-quarter lumpinessCustomer ordering patterns drove a soft $15.8M quarter, reinforcing that the growth story depends on 2L label expansion.—
Commercial durabilityShare maintenanceZYNLONTA maintained its ~10% third-line-plus share despite bispecific competition, supporting the monotherapy base case.—

Q&A Summary

Eric Schmidt (Cantor) asked about the accelerated LOTIS-7 enrollment, how many patients would be in the year-end update, and whether the ~100-patient target could be reached sooner.
Management said interest and enrollment accelerated after the EHA/ICML update, that it still targets roughly 100 patients (now expected to complete in H1 2026, faster than originally planned), and that the year-end update would cover all efficacy-evaluable patients with at least six months of follow-up -- more than the original 20/20 but not the full 100 -- to provide more stable depth and durability data.
Clara Dong / Jenna Lee (Jefferies) asked when ZYNLONTA sales would inflect and how quickly revenue would ramp after positive data or approval.
Management pointed to LOTIS-5 top-line in H1 2026 and approval around H1 2027, with LOTIS-7 publication/compendia between end-2026 and H1 2027, and said that -- as with bispecific and Polivy launches -- the majority of the ramp typically occurs in the first two years post-approval or compendia listing.
Leonid Timashev (RBC) asked how neatly the community-versus-academic split maps to LOTIS-5 (broadly accessible) and LOTIS-7 (complex therapies) and how the sales force would be balanced.
Management pushed back on a strict community/academic dichotomy, saying bispecifics are used across all academic and the more sophisticated community centers, that LOTIS-7 will be used wherever patients are suitable and facilities can administer it, and that LOTIS-5 (R-based regimen) retains a large role for patients unsuitable for immune-based therapy or lacking access.
Sudan Loganathan (Stephens) asked what each share point is worth in 2L versus 3L+ and whether follicular lymphoma data would take share from bispecifics or T-cell therapies.
Management sized ~12,000 2L and ~6,000 3L+ U.S. patients, said durations extend from ~3 cycles (monotherapy) to 5-6 cycles in combination at a net price in the low $20,000s per vial-course, so holding ~10% share in 2L would take the ~$70M run-rate business to just over $200 million; it added MZL has higher unmet need and less competition than the more crowded follicular lymphoma setting.

More on ADC Therapeutics SA

Reported 2025-11-10 · figures from the ADC Therapeutics SA Q3 2025 earnings call.

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