Core Insights - ADC Therapeutics SA is a global leader in antibody drug conjugates (ADCs) and will host a conference call on May 14, 2025, to report Q1 2025 financial results and operational updates [1][2][3] Company Overview - ADC Therapeutics is advancing proprietary ADC technology aimed at transforming treatment for patients with hematologic malignancies and solid tumors [3] - The company is based in Lausanne, Switzerland, with operations in London and New Jersey [5] Product Development - ADC Therapeutics' CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) has received accelerated approval from the FDA and conditional approval from the European Commission for treating relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy [4] - ZYNLONTA is also being developed in combination with other agents and in earlier lines of therapy, alongside multiple ADCs in ongoing clinical and preclinical development [4]

Company Overview - ADC Therapeutics SA (ADCT) is anticipated to report a year-over-year increase in earnings due to higher revenues for the quarter ended March 2025, with a consensus outlook indicating a quarterly loss of $0.38 per share, reflecting a +32.1% change from the previous year [1][3] - Expected revenues for ADC Therapeutics are projected at $18.15 million, which is a slight increase of 0.6% compared to the same quarter last year [3] Earnings Estimates and Revisions - The consensus EPS estimate has been revised 8.33% higher in the last 30 days, indicating a reassessment by analysts of their initial estimates [4] - The Most Accurate Estimate for ADC Therapeutics aligns with the Zacks Consensus Estimate, resulting in an Earnings ESP of 0%, suggesting no recent differing analyst views [10][11] Earnings Surprise Prediction - The Zacks Earnings ESP model indicates that a positive or negative reading can predict the likelihood of actual earnings deviating from consensus estimates, with a positive ESP being a strong predictor of an earnings beat, especially when combined with a Zacks Rank of 1, 2, or 3 [6][8] - ADC Therapeutics currently holds a Zacks Rank of 3, making it challenging to predict a definitive earnings beat [11] Historical Performance - In the last reported quarter, ADC Therapeutics was expected to post a loss of $0.35 per share but actually reported a loss of $0.29, resulting in a surprise of +17.14% [12] - Over the past four quarters, the company has surpassed consensus EPS estimates two times [13] Industry Context - In the Zacks Medical - Biomedical and Genetics industry, Cardiff Oncology (CRDF) is expected to report a loss of $0.19 per share for the same quarter, indicating a year-over-year change of +13.6% [17] - Cardiff Oncology's revenue is projected to be $0.17 million, down 19.1% from the previous year, but it has an Earnings ESP of 24.32% and a Zacks Rank of 2, suggesting a higher likelihood of beating the consensus EPS estimate [18]

Core Insights - ADC Therapeutics presented promising data on exatecan-based antibody drug conjugates (ADCs) targeting Claudin-6, PSMA, and ASCT2 at the AACR Annual Meeting 2025, indicating their potential in treating various cancers [1][2][3] Group 1: ADC Therapeutics Overview - ADC Therapeutics is a global leader in the field of antibody drug conjugates (ADCs), focusing on transforming treatment paradigms for patients with hematologic malignancies and solid tumors [5] - The company has received FDA accelerated approval for its CD19-directed ADC ZYNLONTA for treating relapsed or refractory diffuse large B-cell lymphoma [6] Group 2: Research Findings - ADCT-242, targeting Claudin-6, showed potent anti-tumor activity in ovarian and non-small cell lung cancer models, demonstrating good tolerability in preclinical studies [2][8] - ADCT-241, a PSMA-targeting ADC, exhibited antitumor activity in xenograft and patient-derived models, with well-tolerated results in rats and cynomolgus monkeys [2][3] - HuB14-VA-PL2202, an ASCT2-targeting ADC, demonstrated specific antitumor activity in both solid and hematological cancer cell lines, also showing good tolerability in cynomolgus monkeys [3]

Company Overview - ADC Therapeutics SA is a commercial-stage global leader in the field of antibody drug conjugates (ADCs) [3] - The company is focused on transforming treatment paradigms for patients with hematologic malignancies and solid tumors [3] Recent Developments - CEO Ameet Mallik will present a company overview at the 24th Annual Needham Virtual Healthcare Conference on April 8, 2025 [1] - A live webcast of the presentation will be available on the company's website, with a replay accessible for approximately 30 days [2] Product Pipeline - ADC Therapeutics' CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) has received accelerated approval from the FDA and conditional approval from the European Commission for treating relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy [4] - ZYNLONTA is also being developed in combination with other agents and in earlier lines of therapy [4] - The company has multiple ADCs in ongoing clinical and preclinical development [4] Company Operations - ADC Therapeutics is based in Lausanne, Switzerland, with operations in London, the San Francisco Bay Area, and New Jersey [5]

Company Overview - ADC Therapeutics SA is a commercial-stage global leader in the field of antibody drug conjugates (ADCs) [3] - The company is focused on transforming treatment paradigms for patients with hematologic malignancies and solid tumors [3] Recent Developments - CEO Ameet Mallik will present a company overview at the 24th Annual Needham Virtual Healthcare Conference on April 8, 2025, at 8:00 a.m. ET [1] - A live webcast of the presentation will be available on the company's website, with a replay accessible for approximately 30 days [2] Product Pipeline - ADC Therapeutics' CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) has received accelerated approval from the FDA and conditional approval from the European Commission for treating relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy [4] - ZYNLONTA is also being developed in combination with other agents and in earlier lines of therapy [4] - The company has multiple ADCs in ongoing clinical and preclinical development [4] Company Operations - ADC Therapeutics is headquartered in Lausanne, Switzerland, with operations in London, the San Francisco Bay Area, and New Jersey [5]

Financial Data and Key Metrics Changes - The company ended 2024 with $251 million in cash and cash equivalents, expected to fund operations into the second half of 2026 [24] - ZYNLONTA net product revenues for Q4 2024 were $16.4 million, slightly down from $16.6 million in Q4 2023, while full-year revenues were $69.3 million compared to $69.1 million in 2023 [25] - The net loss for Q4 2024 was $30.7 million, a significant improvement from a net loss of $85 million in Q4 2023 [26] - For the full year, the net loss was $157.8 million, down from $240.1 million in 2023 [26] - Non-GAAP operating expenses decreased by 15% year-over-year in Q4 2024, contributing to the reduced net loss [25][26] Business Line Data and Key Metrics Changes - ZYNLONTA maintained its position in the third-line-plus DLBCL market, achieving commercial brand profitability [9] - The company reported an overall response rate of 80% and a complete response rate of 50% in the LOTIS-5 trial, indicating strong efficacy [13] - Initial data from LOTIS-7 showed a best overall response rate of 94% and a complete response rate of 72% among relapsed or refractory DLBCL patients [14] Market Data and Key Metrics Changes - The company anticipates a peak revenue opportunity of $600 million to $1 billion in the US for ZYNLONTA, assuming regulatory approval and compendia listing [19][21] - The potential market opportunity for indolent lymphomas is estimated to be between $100 million and $200 million [22] Company Strategy and Development Direction - The company aims to expand the use of ZYNLONTA into earlier lines of DLBCL therapy through ongoing trials [13] - The strategy includes pursuing research collaborations to advance early-stage solid tumor pipelines [29] - The focus remains on hematology, with a disciplined capital allocation strategy to create value [28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's path forward, highlighting the importance of upcoming data readouts in 2025 [30] - The competitive landscape is expected to evolve with the introduction of new therapies, but management believes ZYNLONTA will maintain its market position [76] Other Important Information - The company achieved a double-digit reduction in operating expenses for the second consecutive year [12] - Management emphasized the importance of regulatory strategies and compendia listings for future growth [50] Q&A Session Summary Question: Update on LOTIS-7 - The company has not disclosed the specific forum or timing for sharing LOTIS-7 data but is on track to enroll 40 patients in Q2 [42] Question: Impact of ADCETRIS Approval - Management believes the approval of ADCETRIS will have limited impact on ZYNLONTA's market share, as it is likely to replace older regimens rather than significantly affect current usage [44] Question: Regulatory Meetings for LOTIS-7 - Discussions with regulatory authorities are planned for the second half of the year once sufficient data is available [50] Question: Market Opportunity in Indolent Lymphoma - The peak opportunity for indolent lymphomas is estimated to be between $100 million and $200 million [51] Question: LOTIS-5 and LOTIS-7 Strategy - Both LOTIS-5 and LOTIS-7 are seen as complementary approaches to address different patient needs in the DLBCL market [56] Question: Importance of Upcoming Presentations - The upcoming presentations at AACR are expected to provide differentiating data on the company's ADC platforms [60] Question: Competitive Landscape for DLBCL - The introduction of bispecifics has taken about a third of the third-line-plus market, but ZYNLONTA has maintained consistent sales [75] Question: Compendia Listing and Market Penetration - Peak penetration for ZYNLONTA is typically achieved within the first two years post-approval or listing [86]

Revenue Performance - Product revenues, net for the year ended December 31, 2024, were $69.3 million, a slight increase of $0.2 million or 0.3% compared to $69.1 million in 2023[395] - License revenues and royalties increased significantly to $1.6 million in 2024 from $0.5 million in 2023, representing a growth of $1.1 million or 212.7%[397] - Total revenue, net for 2024 was $70.8 million, an increase of $1.3 million or 1.8% from $69.6 million in 2023[393] Operating Expenses - Total operating expenses decreased to $201.5 million in 2024 from $235.5 million in 2023, a reduction of $34.1 million or 14.5%[393] - Research and development expenses were $109.6 million for 2024, down $17.5 million or 13.8% from $127.1 million in 2023[403] - Selling and marketing expenses decreased to $44.0 million in 2024, a reduction of $13.4 million or 23.4% compared to $57.5 million in 2023[408] - General and administrative expenses were $41.9 million for the year ended December 31, 2024, a decrease of $6.5 million, or 13.5%, compared to $48.4 million in 2023[413] Net Loss and Financial Performance - The net loss for 2024 was $157.8 million, a decrease of $82.2 million or 34.2% from a net loss of $240.1 million in 2023[393] - Interest income increased to $12.3 million for the year ended December 31, 2024, an increase of $1.7 million, or 16.4%, from $10.5 million in 2023[415] - Interest expense rose to $50.2 million for the year ended December 31, 2024, an increase of $3.9 million, or 8.4%, compared to $46.3 million in 2023[416] - Income tax expense significantly decreased to $0.2 million for the year ended December 31, 2024, from $39.1 million in 2023, primarily due to a full valuation allowance on deferred tax assets[421] Cash Flow and Liquidity - Cash and cash equivalents as of December 31, 2024, were $250.9 million, sufficient to fund operations for at least the next twelve months[426] - Net cash used in operating activities increased to $123.8 million for the year ended December 31, 2024, from $118.7 million in 2023, an increase of $5.1 million[435] - Net cash provided by financing activities was $97.1 million for the year ended December 31, 2024, primarily from the completion of an equity offering[437] Product Development and Strategic Initiatives - ZYNLONTA, the flagship product, received accelerated approval from the FDA and is being expanded into earlier lines of DLBCL and indolent lymphomas[391] - The company is pursuing strategic partnerships and collaborations to maximize the value of its solid tumor program[392] - Research and development expenses for ZYNLONTA specifically were $58.3 million in 2024, down from $68.5 million in 2023, a decrease of $10.2 million or 14.8%[403] Royalty Obligations and Accounting Estimates - Cumulative catch-up adjustment income related to the deferred royalty obligation was $11.2 million for the year ended December 31, 2024, up $6.2 million from $5.0 million in 2023[419] - The deferred royalty obligation involves estimating future royalty payments based on revenue projections, with adjustments made if actual payments differ significantly from estimates[450] - The company uses a Monte Carlo simulation model to estimate the total amount of future royalty payments to HCR, which can vary based on actual net sales of ZYNLONTA[449] - The provision for the discarded drug rebate is recorded in either current or long-term liabilities depending on when refunds are expected to be due[446] - The accounting estimates involve significant uncertainty, and actual results may differ from those estimates under different assumptions[441]

Financial Data and Key Metrics Changes - The company ended 2024 with $251 million in cash and cash equivalents, expected to fund operations into the second half of 2026 [24] - ZYNLONTA net product revenues in Q4 2024 were $16.4 million, slightly down from $16.6 million in Q4 2023, while full-year revenues were $69.3 million compared to $69.1 million in 2023 [25] - The net loss for Q4 2024 was $30.7 million, a significant improvement from a net loss of $85 million in Q4 2023, and the full-year net loss was $157.8 million compared to $240.1 million in 2023 [26][27] Business Line Data and Key Metrics Changes - ZYNLONTA achieved commercial brand profitability and maintained its position in the competitive third-line-plus DLBCL market [9] - The company reported a 13% year-over-year reduction in operating expenses on a non-GAAP basis, with a 15% decrease in Q4 due to operational efficiencies [25][12] Market Data and Key Metrics Changes - The company is focusing on expanding ZYNLONTA's use in earlier lines of DLBCL therapy, with potential peak revenues estimated between $600 million to $1 billion in the US [19][32] - The LOTIS-5 trial aims to expand ZYNLONTA's market opportunity in the second-line setting, potentially leading to peak sales of $200 million to $300 million [20] Company Strategy and Development Direction - The company is pursuing a strategy to expand ZYNLONTA's usage beyond current indications, focusing on commercialization efforts in the US and research collaborations for early-stage solid tumor pipelines [28][29] - The management is confident in the potential of ZYNLONTA to transform lymphoma treatment paradigms, particularly in indolent lymphomas, with an estimated peak revenue opportunity of $100 million to $200 million [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's path forward, highlighting the importance of upcoming data readouts in 2025 to support ZYNLONTA's expansion strategy [31] - The competitive landscape is expected to evolve with the introduction of new therapies, but management believes the impact will be limited due to the established position of ZYNLONTA [76] Other Important Information - The company achieved a double-digit reduction in operating expenses for the second consecutive year, strengthening its balance sheet through equity financing [12][24] - The management plans to engage regulatory authorities and pursue compendia strategies as data from ongoing trials become available [50] Q&A Session Summary Question: Update on LOTIS-7 - The company has not disclosed the specific forum or timing for sharing LOTIS-7 data but is on track to enroll 40 patients in the second quarter [42] Question: Impact of ADCETRIS Approval - Management believes the approval of ADCETRIS will have limited impact, as physicians have multiple options and may replace older regimens rather than directly compete [44] Question: Regulatory Meetings for LOTIS-7 - Discussions with regulatory authorities are planned once sufficient data is available, likely in the second half of the year [50] Question: Market Opportunity in Indolent Lymphoma - The peak opportunity for indolent lymphomas is estimated to be in the $100 million to $200 million range based on compelling data presented [51] Question: LOTIS-5 and LOTIS-7 Strategy - Both LOTIS-5 and LOTIS-7 are seen as complementary approaches to address different patient needs in the DLBCL market [56] Question: Importance of Upcoming Presentations - Upcoming presentations at AACR are expected to provide differentiating data on the company's ADC platform compared to competitors [60] Question: Compendia Listing and Market Share - Recent additions to NCCN guidelines require approximately 100 patients for compendia listing, which is seen as a benchmark for gaining market share [81] Question: Peak Penetration Timeline - Peak penetration for ZYNLONTA is typically achieved within the first two years post-approval, based on historical trends in the DLBCL setting [86]

分组1 - ADC Therapeutics SA reported a quarterly loss of $0.29 per share, better than the Zacks Consensus Estimate of a loss of $0.35, and an improvement from a loss of $1.03 per share a year ago, resulting in an earnings surprise of 17.14% [1] - The company posted revenues of $16.91 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 14.01%, and showing a slight increase from year-ago revenues of $16.79 million [2] - ADC Therapeutics shares have declined approximately 20.6% since the beginning of the year, contrasting with the S&P 500's decline of 2.9% [3] 分组2 - The earnings outlook for ADC Therapeutics is uncertain, with current consensus EPS estimates at -$0.41 on revenues of $20.5 million for the coming quarter, and -$1.47 on revenues of $83.02 million for the current fiscal year [7] - The Zacks Industry Rank for Medical - Biomedical and Genetics is in the top 28% of over 250 Zacks industries, indicating that the industry outlook can significantly impact stock performance [8]

ZYNLONTA Efficacy and Clinical Trial Results - ZYNLONTA monotherapy achieved 48.3% ORR and 24.8% CR in adult patients with relapsed or refractory large B-cell lymphoma, with a median time to CR of 1.5 months[22] - LOTIS-5 (ZYNLONTA + rituximab) showed 80% ORR and 50% CR in a 20-patient safety run-in, with full enrollment completed in 2024[26][29] - LOTIS-7 (ZYNLONTA + bispecific) demonstrated 94% best ORR and 72% CR rate in initial efficacy data (n=18) with a manageable safety profile (n=29)[26] - ZYNLONTA + rituximab in high-risk r/r FL achieved 97% ORR and 77% CR (n=35)[26] - ZYNLONTA monotherapy in r/r MZL showed 91% ORR and 70% CR (n=23)[26] - LOTIS-7 Phase 1b Trial: Best Overall Response indicates an ORR of 94% (17 out of 18) and a CR rate of 72% (13 out of 18) in the efficacy evaluable population[38] - ZYNLONTA Phase 2 IIT Data shows a 70% CR rate in r/r MZL patients, with 91% ORR (21 out of 23) and 70% CR (16 out of 23)[46] - ZYNLONTA + Rituximab Phase 2 IIT Data shows a 77% CR rate in r/r FL patients, with 91% ORR (21 out of 23) and 70% CR (16 out of 23)[47] - Best ORR of 97.4% (n=38) and CR rate of 76.9% (n=30) in a study evaluating ZYNLONTA, with a 12-month PFS of 94.6% after a median follow-up of 15.6 months[63] ZYNLONTA Safety Profile - LOTIS-7 Phase 1b Trial: Safety Summary shows Grade 3/4 TEAEs in 55.2% of patients (16 out of 29), with neutropenia being the most common at 24.1% (7 out of 29)[36] - LOTIS-7 Phase 1b Trial: CRS/ICANS Profile & Management reports 34.5% of patients (10 out of 29) experienced any grade of Cytokine Release Syndrome (CRS), with no Grade >3 cases[37] - Safety profile of ZYNLONTA consistent with known data, with no Grade 5 TEAEs reported[63] ZYNLONTA Commercial and Financial Performance - ZYNLONTA stabilized sales and achieved commercial brand profitability despite increased competition[15] - Cash runway is expected to extend into mid-2026, supported by disciplined portfolio management and double-digit cost reductions[15] - ZYNLONTA U.S. Peak Revenue Potential is estimated at $600M-1B, driven by its efficacy and manageable safety profile[53] - LOTIS-5: Phase 3 Confirmatory Trial of ZYNLONTA in Combination with Rituximab in 2L+ DLBCL is ongoing, with potential revenue of $200-300M[55][56] - Future Treatment Shares by Line of Therapy indicate that ZYNLONTA + Rituximab could capture 22% of 2L patients and 21% of 3L+ patients, with a median number of cycles increasing from three to five[57] Next-Generation ADC Platform and Pipeline Development - The company is advancing a next-generation ADC platform targeting Claudin-6, PSMA, NaPi2b, and ASCT2 with an exatecan-based payload and novel hydrophilic linker[13] - ADCT advancing a broad portfolio of investigational ADCs targeting Claudin-6, PSMA, NaPi2b, and ASCT2, with IND-enabling studies ongoing[68] - ADCT's proprietary linker technology enables precise site-specific attachment of diverse payloads with tunable DAR[60] - ADCT's exatecan-based ADCs show increased bystander effect, potency, and lower risk of multi-drug resistance compared to DXd[67] - Exatecan-based ADC demonstrated superior therapeutic index and better response compared to DXd-based ADC at equivalent doses[67] Corporate Strategy and Business Development - Corporate strategy includes co-development, royalty, and milestone-based partnerships to maximize deal value and accelerate asset development[69] - ZYNLONTA potential BLA submission to regulatory authorities expected by end of 2025, with topline results anticipated[71] - ADCT plans to pursue business development opportunities to expand the portfolio and fund early-stage pipeline[71] Clinical Trial Expansion and Updates - LOTIS-7 Phase 1b trial of ZYNLONTA in combination with glofitamab began enrollment in July 2023, with dose escalation completed and initial efficacy/safety updates expected[31][32] - University of Miami expanding the trial to 100 high-risk r/r FL patients and opening the study at additional US cancer research centers[63] ZYNLONTA Market Positioning and Indication Expansion - ZYNLONTA is positioned for potential expansion into earlier lines of therapy and new indications, including 2L+ DLBCL and indolent lymphomas (FL and MZL)[11][25]