Release Date: March 27, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- ADC Therapeutics SA (ADCT, Financial) achieved commercial brand profitability with ZYNLONTA in the competitive third-line plus DLBCL space.
- The company completed enrollment in the pivotal Phase 3 LOTIS-5 trial and reported promising initial data from the LOTIS-7 trial.
- ADCT achieved a double-digit reduction in operating expenses for the second consecutive year, strengthening its financial position.
- The company ended 2024 with $251 million in cash and cash equivalents, providing a cash runway into the second half of 2026.
- Promising Phase 2 data from investigator-initiated trials in indolent lymphomas suggest potential for significant market opportunities.
Negative Points
- ZYNLONTA's net product revenues remained flat year-over-year, indicating challenges in revenue growth.
- The competitive landscape in the third-line plus DLBCL market remains intense, with new entrants like Pfizer's ADCETRIS posing potential challenges.
- Despite progress, the company reported a net loss of $157.8 million for the full year 2024.
- The market for ZYNLONTA in indolent lymphomas is estimated to be $100 million to $200 million, which may be considered modest.
- The company faces uncertainty regarding the timing and outcome of regulatory approvals and compendia listings for its pipeline products.
Q & A Highlights
Q: Can you provide details on the LOTIS-7 update expected in Q2?
A: We haven't disclosed the specific forum or exact timing within Q2 for sharing the LOTIS-7 data. However, we are on track to enroll 40 patients in the dose expansion in the second quarter. We will share safety and efficacy data on a portion of those patients in Q2 and data on all 40 patients in the second half of the year. - Ameet Mallik, CEO
Q: How do you view the impact of Pfizer's ADCETRIS approval on ZYNLONTA's market position?
A: The approval of ADCETRIS plus R-squared in the third-line setting is expected to have limited impact. Physicians have multiple options, and based on our market research, any use of ADCETRIS is likely to replace older regimens like R-squared or R-based chemo in the third-line plus DLBCL setting. - Ameet Mallik, CEO
Q: What is the market opportunity for ZYNLONTA in indolent lymphomas?
A: Based on compelling data presented in marginal zone lymphoma and follicular lymphoma, we believe the peak opportunity for ZYNLONTA in indolent lymphomas will be in the $100 million to $200 million range, assuming regulatory approval and compendia listing. - Ameet Mallik, CEO
Q: How does the LOTIS-5 trial impact your strategy for LOTIS-7?
A: LOTIS-5 and LOTIS-7 are complementary approaches addressing different patient needs. LOTIS-5 offers a non-systemic chemo combination with favorable safety and convenience, while LOTIS-7 aims to be the preferred bispecific combination in second-line plus DLBCL. Both approaches allow us to cater to patients who can't access or are not suitable for CAR-T or bispecific therapies. - Ameet Mallik, CEO
Q: What are the benchmarks for LOTIS-5 to be considered competitive in terms of efficacy and safety?
A: For LOTIS-5, a complete response rate north of 40% would be differentiated. The study is powered to show a two-month difference in PFS compared to R-GemOx, which typically has a PFS of three to four months. We are encouraged by the safety run-in data showing an overall response rate of 80% and a complete response rate of 50%. - Ameet Mallik, CEO
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
