ADC Therapeutics SA Q3 FY2024 earnings call

• Focused on execution and commercial strategy, securing ZYNLONTA as a treatment option for third-line plus patients with DLBCL.
• LOTIS-5 Phase III confirmatory study of ZYNLONTA in combination with rituximab in second-line plus DLBCL nearing completion, full enrollment expected by end of year, data expected by end of 2025.
• LOTIS-7 Part 2 dose expansion of ZYNLONTA plus glofitamab combination arm in second-line plus DLBCL to have interim data including safety and efficacy in December, additional data in first half of 2025.
• 2 key investigator-initiated trials on ZYNLONTA in indolent lymphomas to be presented at ASH meeting in December.
• Discontinued Phase Ib ADCT-601 program in solid tumors, prioritizing exatecan-based platform in solid tumors with IND-enabling studies ongoing and one target expected to move toward IND in 2025.
• Continues to explore potential partnership opportunities.

Third quarter net product revenues increased to $18 million, bringing year-to-date ZYNLONTA revenues to $52.9 million. ZYNLONTA's net product revenues were $18.0 million for the third quarter and $52.9 million for the first 9 months of 2024 compared to $14.3 million and $52.4 million for the same periods in 2023. ZYNLONTA contributes significantly to the company's revenue, with third quarter revenue making up a portion of the total and year-to-date showing growth.

• Enrollment in LOTIS-5 expected to be completed by end of 2024, data from LOTIS-5 expected by end of 2025 once prespecified number of events is reached.
• Interim data from LOTIS-7 Part 2 dose expansion expected in December, additional data in first half of 2025.
• Key potential value-driving milestones before end of 2024 include completion of enrollment in LOTIS-5 and initial efficacy and safety data from LOTIS-7 Part 2 dose expansion in December as well as presentation of updated indolent lymphoma Phase II IIT data at ASH.
• Cash and cash equivalents of $274.3 million at end of third quarter expected to fund operations into mid-2026 based on current plans.

• Forward-looking statements are subject to known and unknown risks and uncertainties, actual results could differ materially. Risks are identified and described in the accompanying slide presentation and in the company's filings with the SEC.
• Competition in the market, such as from bispecific antibodies, which have penetrated the market and taken market share.

Q: Could you comment a little bit more about the commercialization of ZYNLONTA in its approved indication?

A: Since bispecifics launched over a year ago, they've penetrated significantly in academic and third-line settings, with more referrals between community and academic. ZYNLONTA's volume is relatively stable with 50-50 mix between community and academic, and anticipates an $80-plus million peak sales potential in the current indication.

Q: On the LOTIS-7 data later this year, what is a positive result here? What are you looking for in this initial data for LOTIS-7?

A: Hopes to see overall response rates and CR and PR rates competitive with other bispecific combinations, and continued improvement in the overall rates and severity of CRS, including no high-grade CRS.

Q: Coming back to AXL601 and sort of the solid tumor opportunity. Is there anything you learned from your decision to give this a quick hook?

A: When doing dose escalation, saw initial clinical activity, but during dose optimization expansion phase, couldn't sustain efficacy with favorable tolerability profile, leading to decision to discontinue the program as benefit risk wasn't there.

Q: Can you be a little bit more specific on time lines for a next solid tumor IND filing and/or partnership conclusion discussion?

A: Shifted solid tumor strategy towards newer payloads, already picked one program progressing towards IND, timing not given yet, likely a 2025 event; between drug candidate selection until IND, takes about 18 months on average.

Q: For ZYNLONTA sales, could you quantify the magnitude or percent increase in net pricing?

A: Take twice a year price increases in low single digit, compounded annually is mid-single digit roughly.

Q: For LOTIS-7 trial, what kind of synergy you expect from this combo, particularly on durability front? And are there any community centers involved for this ongoing trial?

A: Hope to see additive or synergistic efficacy, and the trial is in academic centers and large community centers, testing in a representative sample of second-line plus patients.

Q: On LOTIS-7, what would the data need to look like to be considered as a meaningful improvement from bispecific or bispecific plus chemo?

A: Hopes to see no high-grade CRS (Grade 3 and Grade 4) and strong efficacy, improving on both dimensions versus bispecific monotherapy.

Q: What should we be expecting for the indolent lymphoma update at ASH? And what are the sizes of this data set that will be needed for the compendia listing? And time line?

A: Expect updated data in presentations at ASH, for MZL data set size can be around 36-50 patients, for FL 100-patient study; timing, further updates at ASH with enrollment not in control, but continues due to high unmet need in both settings