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ADC Therapeutics(ADCT) - 2024 Q1 - Quarterly Results
2024-05-06 10:29
Financial Performance - ZYNLONTA® net sales reached $17.8 million in Q1 2024, a 7% increase from Q4 2023 but a 6% decrease from Q1 2023[3] - Total operating expenses decreased by 25% (adjusted total operating expenses decreased by 16%) compared to Q1 2023[1] - Net loss decreased to $46.6 million in Q1 2024 from $59.4 million in Q1 2023, driven by lower operating expenses[13] - Adjusted net loss was $31.1 million in Q1 2024, compared to $41.8 million in Q1 2023[13] - Total revenue for Q1 2024 was $18.053 million, a decrease of 5% compared to $18.992 million in Q1 2023[27] - Net loss for Q1 2024 was $46.606 million, an improvement from $59.374 million in Q1 2023[27] - Adjusted net loss for Q1 2024 was $31.147 million, compared to $41.759 million in Q1 2023[31] - Adjusted net loss per share for Q1 2024 was $0.38, compared to $0.52 in Q1 2023[31] - Total operating expenses decreased by 25% to $51.666 million in Q1 2024 from $69.202 million in Q1 2023[27] - Adjusted total operating expenses decreased by 16% to $51.508 million in Q1 2024 from $61.128 million in Q1 2023[30] - ZYNLONTA® product revenues decreased to $17.848 million in Q1 2024 from $18.953 million in Q1 2023[27] Cash Position and Runway - Cash and cash equivalents were $234.3 million as of March 31, 2024, with cash runway expected to extend into Q4 2025[8] - Cash and cash equivalents decreased to $234.285 million as of March 31, 2024, from $278.598 million as of December 31, 2023[28] - The company expects its cash runway to extend into the beginning of Q4 2025[24] Research and Development - LOTIS-7 dose escalation completed and expansion initiated in 2L+ DLBCL, with no dose-limiting toxicities observed[3][4] - Initial Phase 2 data from 15 MZL patients showed 13 complete responses (CR) and 1 partial response (PR)[4] - ADCT-601 Phase 1b trial continues enrollment in pancreatic cancer monotherapy arm, with additional data updates expected in H2 2024[5][7] - R&D expenses decreased to $25.7 million in Q1 2024 from $38.4 million in Q1 2023, primarily due to reduced investment in camidanlumab tesirine (Cami)[10] - Research and development expenses decreased to $25.735 million in Q1 2024 from $38.375 million in Q1 2023[27] - Preclinical data on Claudin-6 and NaPi2b targeting ADCs demonstrated potent anti-tumor activity and tolerability[5]
ADC Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Updates
Newsfilter· 2024-05-06 10:10
ZYNLONTA® (loncastuximab tesirine-lpyl) net sales of $17.8 million in 1Q 2024; total operating expenses decreased 25% (adjusted total operating expenses decreased 16%)1 compared to 1Q 2023 Successfully completed LOTIS-7 dose escalation and initiated expansion in 2L+ DLBCL Initial MZL IIT Phase 2 data from 15 patients showed 13 patients with CR and 1 patient with PR; encouraging data compared to current treatments in area with high unmet medical need Research event featured next-generation ADC platform and t ...
ADC Therapeutics Announces Initial Data from Investigator-Initiated Phase 2 Clinical Trial of ZYNLONTA® in Patients with Relapsed/Refractory Marginal Zone Lymphoma
Newsfilter· 2024-05-06 10:00
Initial data from 15 patients with relapsed/refractory (r/r) marginal zone lymphoma (MZL) show 13 patients achieved a complete response and one patient achieved a partial response with ZYNLONTA® All patients achieving responses maintained them at the time of data cutoff ZYNLONTA was generally well-tolerated and safety was consistent with known profile Data were presented at Lymphoma Research Foundation's 2024 Marginal Zone Lymphoma Scientific Workshop LAUSANNE, Switzerland, May 06, 2024 (GLOBE NEWSWIRE) -- ...
ADC Therapeutics Announces Updates on LOTIS-7 Clinical Trial Evaluating ZYNLONTA® in Combination with Glofitamab or Mosunetuzumab in Patients with Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Newsfilter· 2024-04-04 11:00
Core Insights - ADC Therapeutics has completed the dose escalation phase of the LOTIS-7 trial for ZYNLONTA in combination with bispecific antibodies for treating relapsed/refractory B-cell non-Hodgkin lymphoma, showing no dose-limiting toxicities and early signs of anti-tumor activity [1][2][3] Group 1: Trial Details - The LOTIS-7 trial is a Phase 1b open-label study evaluating ZYNLONTA in combination with glofitamab or mosunetuzumab in heavily pre-treated patients [1][3] - In the dose escalation portion, no dose-limiting toxicities, low-grade cytokine release syndrome, or immune effector cell-associated neurotoxicity syndrome were observed [2][3] - Enrollment in Part 2 of the trial has begun, focusing on dose expansion with ZYNLONTA at 120 µg/kg and 150 µg/kg [2][3] Group 2: Efficacy and Safety - Early data indicate evidence of anti-tumor activity among the majority of patients, including those with diffuse large B-cell lymphoma, follicular lymphoma, and marginal zone lymphoma [2][3] - The favorable toxicity profile observed in the trial is encouraging given the unmet medical need in treating relapsed or refractory B-cell non-Hodgkin lymphoma [3] Group 3: Company Overview - ADC Therapeutics is a leader in the field of antibody drug conjugates, with ZYNLONTA receiving accelerated approval from the FDA and conditional approval from the European Commission for treating relapsed or refractory diffuse large B-cell lymphoma [8][9] - The company is advancing its proprietary ADC technology and has multiple ADCs in ongoing clinical and preclinical development [8][9]
ADC Therapeutics to Host a Virtual Research Investor Event on Tuesday, April 9, 2024
Newsfilter· 2024-04-03 11:00
LAUSANNE, Switzerland, April 03, 2024 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE:ADCT) today announced that the Company will host a virtual Research Investor Event on Tuesday, April 9, 2024, from 4:00 to 5:30 p.m. EDT. The event will feature presentations from Ameet Mallik, Chief Executive Officer, and Patrick van Berkel, PhD, Chief Scientific Officer, highlighting recent updates and the Company's novel exatecan-based antibody drug conjugate platform. A live question and answer session will follow the pr ...
ADC Therapeutics(ADCT) - 2023 Q4 - Earnings Call Transcript
2024-03-13 17:24
Financial Data and Key Metrics Changes - The company reported a net loss of $85 million for Q4 2023, resulting in a full-year net loss of $240 million, or $2.94 per share [32] - ZYNLONTA net sales were $16.6 million in Q4, a decrease of 16% compared to the prior year, primarily due to higher gross-to-net from discounted drug rebates and slightly lower volume [31] - Total operating expenses on a non-GAAP basis decreased by 24% compared to Q4 of the previous year, reflecting a focus on operational efficiencies and reduced R&D expenditure [31] Business Line Data and Key Metrics Changes - ZYNLONTA achieved double-digit sequential sales growth in Q4, with revenues of $16.6 million, indicating a recovery in demand in both community and academic settings [9][12] - The company is focusing on expanding the ZYNLONTA franchise, particularly in earlier lines of DLBCL therapy and indolent lymphomas, with potential peak sales exceeding $0.5 billion [7][9] Market Data and Key Metrics Changes - The DLBCL market is evolving, with a need for effective combinations as polatuzumab moves to the front line, creating an unmet need for re-treatment in the relapse/refractory setting [14][56] - The competitive landscape is shifting towards combinations, with ZYNLONTA positioned as a single-agent therapy with strong activity, which is rare in the current market [55] Company Strategy and Development Direction - The company has implemented a new corporate and capital allocation strategy, focusing on hematology and the ZYNLONTA franchise as the primary growth driver [6][7] - The second pillar of the strategy involves advancing an emerging solid tumor pipeline, with ADCT-601 as the most advanced asset [7][23] - The company aims to progress multiple assets in parallel, supported by non-dilutive funding from partners [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's repositioning and refocusing efforts, entering 2024 with a clear strategic roadmap [11][33] - The company anticipates a cash runway into Q4 2025, supporting multiple value-generating catalysts [11][30] Other Important Information - The company ended 2023 with approximately $278.6 million in cash, a decrease of $32 million from Q3 [31] - The company is advancing an early-stage portfolio of investigational ADCs utilizing a novel exatecan-based platform [26][28] Q&A Session Summary Question: Can you talk about the safety data with bispecifics in combination to date? - Management noted that they are encouraged by the lack of dose-limiting toxicities (DLTs) observed in the LOTIS-7 study, with low-grade cytokine release syndrome (CRS) that resolves quickly [37][39] Question: What are the penetration levels with ZYNLONTA in academic and community settings? - Management indicated that while exact numbers are not shared, there has been a strong foundation in the academic setting, and a refined strategy focusing on the community has led to increased demand [40] Question: Can you elaborate on the censoring in LOTIS-5? - Management explained that higher than expected censoring is common in global open-label Phase 3 trials, primarily due to patient and physician preferences for active arms [42][44] Question: What does commercial brand profitability entail? - Management expects that revenues from ZYNLONTA will cover all expenses related to its commercialization, allowing it to become a source of funds for pipeline development [47] Question: What are the dynamics of uptake for 2024? - Management noted that while bispecifics are gaining ground, ZYNLONTA has a clear role for patients who may not be suitable for bispecifics or who progress after treatment [55]
ADC Therapeutics(ADCT) - 2023 Q4 - Earnings Call Presentation
2024-03-13 14:13
4Q 2023 Earnings Call Forward-Looking Statements This presentation and any accompanying oral presentation have been prepared by ADC Therapeutics SA ("ADC Therapeutics“, “we” or “us”) for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, a recommendation, promise or representation by the presenter or ADC Therapeutics or any officer, director, employee, agent or advisor of ADC Therapeutics. This presentation does not purport to be ...
ADC Therapeutics SA (ADCT) Reports Q4 Loss, Tops Revenue Estimates
Zacks Investment Research· 2024-03-13 13:21
ADC Therapeutics SA (ADCT) came out with a quarterly loss of $1.03 per share versus the Zacks Consensus Estimate of a loss of $0.47. This compares to loss of $0.30 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -119.15%. A quarter ago, it was expected that this company would post a loss of $0.61 per share when it actually produced a loss of $0.58, delivering a surprise of 4.92%.Over the last four quarters, the company has sur ...
ADC Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Updates
Newsfilter· 2024-03-13 11:00
ZYNLONTA® (loncastuximab tesirine-lpyl) net sales of $16.6 million in 4Q 2023 and $69.1 million for full year (FY) 2023; 4Q sales grew sequentially in both academic and community settings Focused pipeline progressing with continued LOTIS-7 dose escalation, screening patients for ADCT-601 targeting AXL in pancreatic cancer, and advancing differentiated solid tumor research platform FY 2023 operating expenses decreased 21%1 year-over-year due to portfolio prioritization and operational efficiencies; $278.6M o ...
ADC Therapeutics(ADCT) - 2023 Q4 - Annual Report
2024-03-12 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39071 ADC Therapeutics SA (Exact name of registrant as specified in its charter) Switzerland Not Applicable (State or other jurisdic ...