LAUSANNE, Switzerland, April 1, 2025 /PRNewswire/ -- ADC Therapeutics SA (NYSE: ADCT) announced today that Ameet Mallik, Chief Executive Officer, will present a company overview at the 24th Annual Needham Virtual Healthcare Conference on Tuesday, April 8, 2025, at 8:00 a.m. ET. A live webcast of the presentation will be available via the Events & Presentations page in the Investors section of ADC Therapeutics' website, ir.adctherapeutics.com. A replay of the webcast will be available for approximately 30 da ...

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 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]

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]

Core Insights - ADC Therapeutics is set to present preclinical data on its exatecan-based antibody-drug conjugates (ADCs) targeting Claudin-6, PSMA, and ASCT2 at the upcoming AACR Annual Meeting 2025, highlighting its commitment to advancing targeted cancer treatments [1][2][3] Company Overview - ADC Therapeutics is a commercial-stage global leader in the field of antibody-drug conjugates (ADCs), focusing on transforming treatment paradigms for patients with hematologic malignancies and solid tumors [3][4] - The company is based in Lausanne, Switzerland, with operations in London and New Jersey [5] Upcoming Presentations - The oral presentation will focus on ADCT-242, a novel exatecan-based ADC targeting Claudin-6, in ovarian and non-small lung cancer models, scheduled for April 27, 2025 [2] - Poster presentations will include: - ADCT-241, targeting PSMA for prostate cancer, on April 30, 2025 [2] - HuB14-VA-PL2202, targeting ASCT2, on April 28, 2025 [2] Product Development - ADC Therapeutics' CD19-directed ADC ZYNLONTA has received accelerated approval from the FDA and conditional approval from the European Commission for treating relapsed or refractory diffuse large B-cell lymphoma [4]

Core Insights - ADC Therapeutics SA is a global leader in antibody drug conjugates (ADCs) and is advancing proprietary ADC technology to improve treatment for hematologic malignancies and solid tumors [3]. Company Overview - ADC Therapeutics is based in Lausanne, Switzerland, with operations in London and New Jersey [5]. - The company has received FDA accelerated approval and conditional approval from the European Commission for its CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) 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]. Upcoming Events - Ameet Mallik, the CEO of ADC Therapeutics, will participate in a fireside chat at the Guggenheim SMID Cap Biotech Conference on February 6, 2025, at 2:00 p.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].

Financial Data and Key Metrics Changes - In Q3 2024, net product revenues increased to $18 million, bringing year-to-date ZYNLONTA revenues to $52.9 million, compared to $14.3 million and $52.4 million for the same periods in 2023 [7][22] - The net loss for Q3 2024 was $44 million, or $0.42 per share, compared to a net loss of $46.7 million, or $0.57 per share for the same period in 2023 [26] - On a non-GAAP basis, adjusted net loss was $29.4 million, or $0.28 per share, compared to an adjusted net loss of $32.4 million, or $0.39 per share for the same period in 2023 [27] Business Line Data and Key Metrics Changes - The growth in ZYNLONTA revenues was primarily driven by volume increases and a net price increase [22] - Non-GAAP operating expenses decreased by 12% year-over-year for the first nine months of 2024, while Q3 operating expenses increased by 5% due to investments in clinical trials [23][24] Market Data and Key Metrics Changes - The market for DLBCL treatments has evolved to include cellular therapies, bispecifics, ADCs, and monoclonal antibodies, with a shift towards combinations that offer rapid, deep, and durable responses [14] - ZYNLONTA is positioned well for use in combination therapies in second-line plus DLBCL due to its efficacy, safety, and accessibility [13] Company Strategy and Development Direction - The company aims to expand the use of ZYNLONTA beyond its current indication by supporting commercialization efforts in the U.S. and exploring partnerships for international markets [28] - In solid tumors, the focus will be on pursuing multiple ADC candidates in parallel, leveraging a novel exatecan-based research platform [29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in ZYNLONTA's profile and its potential to expand into earlier lines of therapy in DLBCL and indolent lymphomas [7][31] - The company anticipates key milestones, including the completion of enrollment in LOTIS-5 and initial data from LOTIS-7, which are expected to drive value creation [31] Other Important Information - The company ended Q3 2024 with $274.3 million in cash and cash equivalents, expected to fund operations into mid-2026 [22] - The decision to discontinue the Phase Ib ADCT-601 program was based on an unfavorable benefit-risk profile during the dose optimization phase [11] Q&A Session Summary Question: Comment on the commercialization of ZYNLONTA in its approved indication - Management noted increased competition from bispecifics but indicated stable demand for ZYNLONTA, maintaining a 50-50 mix between community and academic settings [34][36] Question: What are the expectations for LOTIS-7 data? - Management aims for overall response rates and CR/PR rates in the range of 50% to 60%, while also monitoring the rates and severity of CRS [38][39] Question: Insights on the AXL601 solid tumor opportunity - The decision to halt the AXL601 program was due to an inability to sustain desired efficacy with a favorable tolerability profile [42][44] Question: Timeline for the next solid tumor IND filing - The timeline for an IND filing is approximately 18 months from drug candidate selection, with updates expected in 2025 [46][47] Question: Expectations for LOTIS-7 synergy and community center involvement - Management expects additive or synergistic efficacy from the combination of ZYNLONTA and glofitamab, with trials conducted in both academic and community centers [50][52] Question: Data requirements for indolent lymphoma updates at ASH - Management indicated that updated data will be presented at ASH, with a focus on patient sample sizes that have historically been sufficient for inclusion in guidelines [56][58]

Revenue Growth - Product revenues, net, increased to $18.0 million for the three months ended September 30, 2024, compared to $14.3 million for the same period in 2023, representing a 26.3% increase [118]. - License revenues and royalties rose to $448 thousand for the three months ended September 30, 2024, up from $226 thousand in the same period of 2023, marking a 98.2% increase [120]. - Total revenue, net, reached $18.5 million for the three months ended September 30, 2024, compared to $14.5 million for the same period in 2023, reflecting a 27.4% increase [116]. - Total revenue increased by $1.2 million or 2.2%, from $52.8 million in the nine months ended September 30, 2023 to $53.9 million in the same period of 2024 [146]. - Product revenues, net, increased by $0.5 million or 0.9%, from $52.4 million in the nine months ended September 30, 2023 to $52.9 million in the same period of 2024, primarily due to higher pricing [147]. - License revenues and royalties surged by $0.7 million or 194.3%, from $0.4 million in the nine months ended September 30, 2023 to $1.0 million in the same period of 2024 [149]. Expenses and Losses - Research and development expenses totaled $32.5 million for the three months ended September 30, 2024, an increase of $5.4 million or 20.0% from $27.1 million in the same period of 2023 [124]. - Cost of product sales increased to $0.9 million for the three months ended September 30, 2024, compared to $0.2 million in the same period of 2023, a significant increase of 309.1% [122]. - The net loss for the three months ended September 30, 2024, was $43.9 million, a decrease of $2.8 million or 5.9% from a net loss of $46.7 million in the same period of 2023 [116]. - Loss from operations was $35.6 million for the three months ended September 30, 2024, slightly improved from a loss of $36.1 million in the same period of 2023, a change of 1.6% [116]. - Research and development expenses for ZYNLONTA were $18.2 million for the three months ended September 30, 2024, compared to $17.1 million in the same period of 2023, an increase of $1.1 million [125]. - Selling and marketing expenses decreased by $3.1 million or 22.3%, from $13.7 million in Q3 2023 to $10.7 million in Q3 2024, primarily due to reduced marketing initiatives in the U.S. [132]. - General and administrative expenses increased by $0.4 million or 3.9%, from $9.6 million in Q3 2023 to $10.0 million in Q3 2024, driven by higher employee expenses and recruitment costs [136]. - Interest expense increased by $0.3 million or 2.3%, from $12.8 million in Q3 2023 to $13.1 million in Q3 2024, mainly due to higher accretion of deferred royalty obligations [139]. - The net loss decreased by $27.9 million or 18.0%, from $155.0 million in the nine months ended September 30, 2023 to $127.1 million in the same period of 2024 [146]. - The loss from operations improved by $27.8 million or 22.1%, from $126.0 million in the nine months ended September 30, 2023 to $98.2 million in the same period of 2024 [146]. - Selling and marketing expenses decreased to $32.8 million for the nine months ended September 30, 2024, from $43.5 million in 2023, a reduction of $10.8 million or 24.7% [162]. - Interest expense increased to $38.3 million for the nine months ended September 30, 2024, from $33.4 million in 2023, an increase of $4.9 million or 14.6% [168]. - General and administrative expenses were $32.3 million for the nine months ended September 30, 2024, down from $37.1 million in 2023, a decrease of $4.9 million or 13.1% [165]. Cash Flow and Financing - As of September 30, 2024, the company had cash and cash equivalents of $274.3 million, sufficient to fund operations for at least the next twelve months [176]. - For the nine months ended September 30, 2024, net cash used in operating activities was $102.0 million, an increase of $14.9 million compared to $87.1 million for the same period in 2023 [181]. - The company completed an underwritten offering in May 2024, resulting in net proceeds of approximately $97.4 million [179]. - Net cash provided by financing activities was $98.2 million for the nine months ended September 30, 2024, primarily from the 2024 Equity Offering [183]. - Cash used in investing activities decreased to $0.8 million for the nine months ended September 30, 2024, from $2.9 million in the same period in 2023, reflecting timing of property and equipment purchases [183]. - The net change in cash and cash equivalents for the nine months ended September 30, 2024, was a decrease of $4.6 million, an improvement compared to a decrease of $16.1 million in the same period in 2023 [180]. Strategic Focus - The company is focusing on growing ZYNLONTA in the 3L+ DLBCL setting and advancing its pipeline and ADC platform [179]. - The company is continuously exploring strategic collaborations and licensing opportunities for clinical development and commercialization of ZYNLONTA [177]. - The company has filed a prospectus for an at-the-market offering program with an aggregate offering price of $100 million, although no shares were sold under the program for the three months ended September 30, 2024 [179].

Group 1 - ADC Therapeutics reported a quarterly loss of $0.42 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.36, representing an earnings surprise of -16.67% [1] - The company posted revenues of $18.46 million for the quarter ended September 2024, missing the Zacks Consensus Estimate by 1.56%, and showing an increase from $14.49 million year-over-year [2] - The stock has increased approximately 92.8% since the beginning of the year, outperforming the S&P 500's gain of 24.3% [3] Group 2 - The earnings outlook for ADC Therapeutics is mixed, with the current consensus EPS estimate for the coming quarter at -$0.35 on revenues of $19.76 million, and -$1.72 on revenues of $74 million for the current fiscal year [7] - The Medical - Biomedical and Genetics industry, to which ADC Therapeutics belongs, is currently ranked in the top 36% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8]