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.
| Metric | Period | Current guidance |
|---|---|---|
| LOTIS-5 top-line | Q2 2026 | Top-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 data | End of 2026 | Full data at a medical meeting and publication by end of 2026; pursue compendia inclusion and assess regulatory strategy |
| Indolent lymphoma data | End 2026 - mid 2027 | Additional data at medical conferences; regulatory and compendia strategies to be assessed |
| 2026 revenue | FY2026 | Expected broadly in line with recent years until new indications contribute in 2027 |
| R&D expense | 2026-2027 | Expected to decline as LOTIS-5 winds down and LOTIS-7 passes its enrollment peak |
| Cash runway | Forward | At least into 2028 |
| Metric | YoY | Note |
|---|---|---|
| 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. |
| Topic | Previous mention | Current period | Trend |
|---|---|---|---|
| Three horizons for value creation | Strategy reset | Management 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 dataset | 30-patient EHA/ICML data | December 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 reduction | Restructuring underway | Operating 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 flexibility | HCR obligation | An amended HealthCare Royalty agreement reduced the change-of-control payment, improving strategic flexibility while preserving strong product gross margin. | — |
| Revenue durability vs. inflection | Flat monotherapy base | 2025 volume broadly flat; management expects 2026 revenue in line with recent years and a genuine inflection only from 2027 on LOTIS-5 approval. | — |