Today we issued a press release announcing our fourth quarter and full year 2025 financial results and business updates. You should refer to the company's fourth quarter full year 2025 earnings release for information and reconciliation of historical non-GAAP measures to the comparable GAAP financial measures. These are centered around final data disclosures, approval and compendia inclusion, and ultimately delivering growth. peak revenue opportunity of $600 million-$1 billion, assuming compendia inclusion and regulatory approval, with a highly leveraged cost structure, providing us with broader opportunities to invest in complementary hematology assets.

We undertook a strategic reprioritization to focus resources on ZYNLONTA expansion opportunities, positioning the company for long-term growth with significantly reduced operating expenses. We believe LOTIS-5 has the potential to lift peak annual revenue for ZYNLONTA to $200 million-$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 million-$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 include ADCs, monoclonal antibodies, and chemotherapy. On a full year basis, net product revenues were $73.6 million versus $69.3 million in 2024, with an underlying volume broadly flat. Total operating expenses were $41 million and $202.9 million for the fourth quarter and full year ended December 31, 2025, respectively. On a non-GAAP basis, total adjusted operating expenses were $39.4 million and $181.3 million for the quarter and full year ended December 31, 2025, respectively.

What went well
  • Fourth-quarter net product revenue rebounded strongly to $22.3 million (from $16.4 million a year earlier), driven by customer ordering patterns and the activation of new accounts; full-year 2025 net product revenue was $73.6 million versus $69.3 million in 2024.
  • GAAP net loss narrowed sharply, to $6.4 million ($0.04 per share) in Q4 from $30.7 million ($0.29), and to $142.6 million ($1.12) for the full year from $157.8 million ($1.62).
  • The December LOTIS-7 update showed a 90% best overall response rate and a 78% complete response rate across 49 efficacy-evaluable patients with a minimum of six months of follow-up, with the combination remaining generally well tolerated.
  • The company reduced its operating cost structure by approximately 50% through the strategic reprioritization; full-year non-GAAP operating expenses fell 6% to $181.3 million and Q4 non-GAAP opex fell 15% to $39.4 million.
  • It ended 2025 with $261.3 million of cash and an expected runway at least into 2028, having completed $100 million (June) and $60 million (October) PIPE financings.
  • An amendment to the HealthCare Royalty (HCR) agreement reduced the change-of-control payment, adding strategic flexibility while preserving a still-strong gross margin given low-to-mid-single-digit COGS.
What went wrong
  • Underlying sales volume was broadly flat year over year, with full-year revenue growth driven mostly by net price rather than demand, and quarterly revenue remained lumpy (Q3 low of $15.8M, Q4 high of $22.3M).
  • The company remained deeply loss-making, and management reiterated that a meaningful revenue inflection is not expected until 2027 following LOTIS-5 approval and compendia inclusion.

Guidance Changes

MetricPeriodCurrent guidance
LOTIS-5 top-lineQ2 2026Top-line data in Q2 2026; full publication by year-end 2026; sBLA by year-end; compendia/publication H1 2027; confirmatory approval mid-2027
LOTIS-7 full dataEnd of 2026Full data at a medical meeting and publication by end of 2026; pursue compendia inclusion and assess regulatory strategy
Indolent lymphoma dataEnd 2026 - mid 2027Additional data at medical conferences; regulatory and compendia strategies to be assessed
2026 revenueFY2026Expected broadly in line with recent years until new indications contribute in 2027
R&D expense2026-2027Expected to decline as LOTIS-5 winds down and LOTIS-7 passes its enrollment peak
Cash runwayForwardAt least into 2028

Performance Breakdown

MetricYoYNote
Q4 net product revenue +36% (to $22.3M from $16.4M) Customer ordering patterns and activation of new accounts drove a strong quarter after a soft Q3.
FY2025 net product revenue +6% (to $73.6M from $69.3M) Underlying volume broadly flat; growth driven mainly by net price.
Q4 GAAP net loss Narrowed to $6.4M / $0.04 (from $30.7M / $0.29) Higher cumulative catch-up gain on the deferred royalty obligation and reduced R&D.
FY2025 GAAP net loss Narrowed to $142.6M / $1.12 (from $157.8M / $1.62) Lower R&D and a royalty catch-up gain, partly offset by restructuring and impairment charges.
FY2025 non-GAAP operating expenses -6% (to $181.3M); Q4 -15% (to $39.4M) Reduced spending across all major income-statement lines following the ~50% cost-structure reduction.
Cash and equivalents $261.3M (from $250.9M at Dec 31, 2024) Two PIPE financings ($100M June, $60M October) more than offset operating cash use.

Earnings Call Themes & Trends

TopicPrevious mentionCurrent periodTrend
Three horizons for value creationStrategy resetManagement framed value creation around final data disclosures, approval/compendia inclusion, and delivering growth toward a $600M-$1B U.S. peak revenue opportunity.—
LOTIS-7 maturing dataset30-patient EHA/ICML dataDecember update on 49 patients showed 90% best ORR / 78% CR with a minimum six-month follow-up, supporting best-in-class combination potential.—
Cost structure reductionRestructuring underwayOperating cost structure cut ~50%; FY non-GAAP opex down 6% and Q4 down 15%, with further R&D declines expected in 2026-2027.—
Capital and royalty flexibilityHCR obligationAn amended HealthCare Royalty agreement reduced the change-of-control payment, improving strategic flexibility while preserving strong product gross margin.—
Revenue durability vs. inflectionFlat monotherapy base2025 volume broadly flat; management expects 2026 revenue in line with recent years and a genuine inflection only from 2027 on LOTIS-5 approval.—

Q&A Summary

Maury Raycroft (Jefferies) asked how PFS events are tracking against the 262 required to trigger the LOTIS-5 top-line analysis, whether the readout could slip to Q3, and what would be included.
Management said it is confident in Q2 timing, expects to hit the required events, and will disclose the primary PFS endpoint plus mature secondary endpoints and key safety tables at top-line, reserving deeper sub-analyses for later publication.
Michael Schmidt (Guggenheim) asked whether the ~$200-300 million 2L projection (assuming ~10% share) is too conservative given Monjuvi's move toward front line and softer bispecific data, and about crossover/overall survival in LOTIS-5.
Management said maintaining its ~10% third-line-plus share into 2L would translate to about $300 million, with potential upside if the final clinical profile is differentiating, and that a positive PFS result without detriment to OS and an overall favorable benefit-risk profile would make for a strong FDA submission.
Alexa (for Eric Schmidt, Cantor) asked whether the ~$10 million sequential drop in R&D represents the go-forward run rate.
CFO Jose Carmona said R&D will fluctuate quarter to quarter but is generally expected to trend down through 2026 and 2027 as LOTIS-5 winds down and LOTIS-7 passes its enrollment peak, assuming the current trial slate.
Sudan Loganathan (Stephens) asked about capital-allocation priorities given the amended HCR agreement and the deferred royalty and term-loan obligations, and about the pre-launch marketing strategy.
Management said current cash runway guidance funds all ongoing LOTIS-5, LOTIS-7 and IIT activity plus incremental pre-launch commercial and medical investment; the HCR amendment adds strategic flexibility by reducing the change-of-control payment, and the ~90% DLBCL field-force coverage means only incremental commercial and MSL additions are needed ahead of a mid-2027 LOTIS-5 approval.

More on ADC Therapeutics SA

Reported 2026-03-10 · figures from the ADC Therapeutics SA Q4 2025 earnings call.

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