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.
| Metric | Period | Current guidance |
|---|---|---|
| LOTIS-7 update | Before end of 2025 | Clinical 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 readout | H1 2026 | Top-line data in H1 2026; sBLA, potential approval and compendia inclusion in H1 2027 |
| Indolent lymphoma programs | End 2026 - mid 2027 | Additional conference data by lead investigators; regulatory and compendia strategies to be assessed |
| Cash runway | Forward | At least to 2028, reinforced by the $60 million October financing |
| ZYNLONTA U.S. peak revenue framework | Long-term | Reaffirmed: LOTIS-5 $200-300M, total DLBCL $500-800M, indolent lymphomas $100-200M |
| Metric | YoY | Note |
|---|---|---|
| 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. |
| Topic | Previous mention | Current period | Trend |
|---|---|---|---|
| Indolent lymphoma expansion | MZL and FL IITs | Follicular 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 PIPE | Added a $60M October PIPE (TCGX/Redmile) for pro forma cash of ~$292.3M and a runway at least to 2028. | — |
| Cost discipline | Restructuring completed | Non-GAAP opex down 12.1% year over year with a leaner cost base after the H2 reprioritization. | — |
| Revenue variability | Quarter-to-quarter lumpiness | Customer ordering patterns drove a soft $15.8M quarter, reinforcing that the growth story depends on 2L label expansion. | — |
| Commercial durability | Share maintenance | ZYNLONTA maintained its ~10% third-line-plus share despite bispecific competition, supporting the monotherapy base case. | — |