ADC Therapeutics SA (ADCT) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended March 2025. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, the st ...

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 ...

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]

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].