tisotumab vedotin

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Seagen(SGEN) - 2020 Q2 - Earnings Call Transcript
2025-04-29 20:16
Financial Data and Key Metrics Changes - Total revenues for Q2 2020 were $278 million, driven by record product sales, with a year-to-date total of $513 million [21][5] - Product sales from oncology franchises totaled $240 million, reflecting a 51% increase from the previous year [22] - R&D expenses increased to $198 million in Q2 and $393 million for the first half of 2020, indicating a focus on pipeline investment [24] Business Line Data and Key Metrics Changes - ADCETRIS net sales were $168 million in Q2, with a full-year guidance maintained at $675 million to $700 million [6][25] - PADCEV net sales in the U.S. were $57 million in Q2, a 66% increase from Q1, with full-year guidance set at $215 million to $235 million [7][25] - TUKYSA generated $16 million in revenue in its first partial quarter post-launch [10] Market Data and Key Metrics Changes - The company reported strong adoption of PADCEV for metastatic urothelial cancer, with ongoing trials to expand its use [8][9] - TUKYSA is being positioned in the market for HER2 positive breast cancer, with approvals in multiple countries [10][11] Company Strategy and Development Direction - The company aims to expand the indications for its commercial brands and is advancing over a dozen early-stage assets in clinical and preclinical development [14] - A virtual R&D day is planned to provide more details on the pipeline and commitment to first-in-class therapies [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory despite challenges posed by the COVID-19 pandemic [5] - Positive feedback from KOLs on clinical data supports the potential for accelerated approvals in various indications [13][90] Other Important Information - The company ended Q2 with $896 million in cash and investments, bolstered by the sale of Immunomedics shares [24] - The company is refining its guidance for R&D expenses to a range of $820 million to $870 million for 2020 [25] Q&A Session Summary Question: Insights on TUKYSA's initial launch - Management noted it is early in the launch but is pleased with the awareness and uptake in both academic and community settings [41][42] Question: Factors affecting PADCEV's guidance - Management indicated that while the initial uptake has been strong, growth rates may slow as the launch progresses, with guidance reflecting a 35% to 55% growth rate in the second half [44][47] Question: Gating factors for BLA filing for TV - Management is actively working towards a BLA submission and is encouraged by the positive data from the pivotal trial [51][54] Question: Initial launch feedback for TUKYSA - There is significant enthusiasm among doctors regarding TUKYSA, and it is being used in both patients with and without brain metastases [58][61] Question: Details on the INNO2VATE trial - The trial is focused on evaluating the role of tisotumab vedotin as a single agent or in combination with other therapies for cervical cancer [67] Question: PADCEV usage in frontline settings - Management confirmed ongoing trials to evaluate PADCEV in combination with KEYTRUDA in frontline metastatic disease [75][78]
Seagen(SGEN) - 2020 Q1 - Earnings Call Transcript
2025-04-29 20:11
Financial Data and Key Metrics Changes - Total revenues for Q1 2020 were $235 million, including ADCETRIS net sales of $164 million (up 22% year-over-year) and PADCEV net sales of $34 million [22][6][5] - Royalty revenues increased to $20 million from $16 million in Q1 2019, while collaboration revenues decreased to $16 million from $45 million due to a prior milestone payment [23][24] - R&D expenses were $195 million, reflecting higher investment across the pipeline, while SG&A expenses were $122 million, driven by commercialization efforts [24][25] Business Line Data and Key Metrics Changes - ADCETRIS net sales were $164 million, maintaining guidance for full-year sales between $675 million and $700 million [6][7] - PADCEV achieved net sales of $34 million in its first full quarter, with strong uptake noted particularly in community settings [10][20] - TUKYSA was launched with positive reception, and the company is investing in a broad development program across HER2 positive cancers [12][21] Market Data and Key Metrics Changes - ADCETRIS sales growth was driven by frontline indications in Hodgkin lymphoma and T-cell lymphoma [17] - PADCEV's initial sales performance indicates strong physician and patient reception, with ongoing efforts to evaluate its use in earlier lines of bladder cancer [10][20] - TUKYSA's launch is supported by a dedicated sales force and marketing materials ready on the approval day, indicating strong market entry [21] Company Strategy and Development Direction - The company aims to establish ADCETRIS as the standard of care in frontline Hodgkin lymphoma and PTCL while advancing clinical trials [40] - Continued focus on the PADCEV launch and broad development program, including trials in first-line metastatic and muscle-invasive bladder cancer [40] - TUKYSA's development program includes ongoing regulatory efforts and trials in various HER2 positive cancers [36][37] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in maintaining guidance despite potential impacts from COVID-19, emphasizing the importance of ongoing cancer treatments [28][81] - The company is closely monitoring the impact of COVID-19 on operations and has implemented measures to ensure continuity [28] - Management remains optimistic about the future, citing strong demand for their products and ongoing clinical trials [28][40] Other Important Information - The company is involved in an arbitration process with Daiichi Sankyo regarding technology ownership, which is expected to be more efficient than court proceedings [15][100] - The company has a robust early-stage clinical pipeline, including several ADCs and immunotherapy agents [14] Q&A Session Summary Question: What has been the key drivers for the rapid uptake of PADCEV? - Management noted strong initial sales of $34 million and emphasized the drug's importance for a disease with limited treatment options [42][43] Question: What impact has COVID-19 had on ADCETRIS use? - Management acknowledged potential impacts but maintained that ADCETRIS remains a critical treatment for patients [48][50] Question: What are the plans for TUKYSA regarding co-pay barriers? - The company has established programs to assist eligible patients with co-pay costs to minimize barriers to access [56][59] Question: Can you elaborate on the discussions with the FDA regarding accelerated approval for PADCEV? - Management confirmed strong interactions with the FDA and ongoing enrollment in trials aimed at supporting accelerated approval [62][65] Question: How is the company handling Nectin-4 expression in studies? - The company is measuring Nectin-4 expression in trials and is prepared to adapt if it becomes a relevant biomarker for patient selection [90][93]
Seagen(SGEN) - 2020 Q1 - Earnings Call Presentation
2025-04-28 13:32
Financial Performance - Seattle Genetics reported Q1 2020 net sales of $164 million and maintains its 2020 guidance range of $675 million to $700 million[5] - Total product sales reached $199 million in Q1 2020[14] - Net product sales in Q1 2020 were $1985 million, compared to $135 million in Q1 2019, representing an increase[20] - ADCETRIS net sales increased by 22% from Q1 2019 to Q1 2020[11] - First full quarter of PADCEV sales reached $345 million[19] Product Development and Commercialization - PADCEV is pursuing an accelerated approval pathway in first-line metastatic urothelial cancer[5] - TUKYSA U S launch is underway following a strong FDA label based on HER2CLIMB[5] - The company is expanding European capabilities to support potential ex-U S approvals[5] Clinical Trials and Pipeline - Topline data for tisotumab vedotin from the innovaTV 204 trial is anticipated late in the second or into the third quarter of 2020[3] - Encouraging Phase 1 data with PADCEV plus KEYTRUDA in Cisplatin-Ineligible First-line mUC showed 73% ORR (n=45, cisplatin-ineligible pts)[39] - Seattle Genetics is advancing a broad PADCEV clinical development program, including trials in first-line mUC[40] Financial Outlook - The company's 2020 financial outlook remains unchanged from February 6, 2020, with ADCETRIS U S and Canada net product sales expected to be $675 to $700 million[26]
Seagen(SGEN) - 2020 Q2 - Earnings Call Presentation
2025-04-28 13:25
Julie, treated for metastatic breast cancer on a TUKYSA clinical trial Transformative therapies | Targeting cancer 1 Transformative Therapies | Targeting Cancer Today's Agenda SECOND QUARTER 2020 FINANCIAL RESULTS AND BUSINESS UPDATE July 30, 2020 3 . CLAY SIEGALL, Ph.D. President and CEO | INTRODUCTION | Peggy Pinkston, VP, Investor Relations | | --- | --- | | CEO OPENING REMARKS | Clay Siegall, Ph.D., President & CEO | | COMMERCIAL UPDATE | Chip Romp, EVP, Commercial U.S. | | FINANCIAL RESULTS & GUIDANCE ...
Seagen(SGEN) - 2020 Q3 - Earnings Call Presentation
2025-04-28 13:21
Financial Performance - Total Q3 revenues reached $1.1 billion[7] - Net product sales hit a record $267 million, a 60% increase over 3Q19[7, 14] - Collaboration & license agreement revenues surged to $758.3 million, primarily due to $725 million in upfront payments from Merck[22] - ADCETRIS U S and Canada net product sales guidance is $650 to $660 million[27] - Royalty revenues guidance increased to $125 to $130 million[27] Product Updates - PADCEV and TUKYSA contributed to net product sales growth[22] - PADCEV data supports global registrations and expanded U S indication[8] - TUKYSA is expanding capabilities to support launch in Europe, with MAA under review[8] - Tisotumab vedotin BLA submission planned under FDA accelerated approval pathway[8] Clinical Trial Data - EV-301 trial showed a hazard ratio of 0.70 (P=0.001) for overall survival and 0.61 (P<0.00001) for progression-free survival with PADCEV[34] - EV-201 Cohort 2 trial showed a 52% objective response rate with PADCEV[34] - Tisotumab Vedotin showed a confirmed ORR of 24%[42] Strategic Collaborations - Received $1.8 billion under Merck collaborations, including upfront payments and prepaid R&D in Q3, and a $1 billion equity investment closed in Q4[7] - Granted Merck exclusive license to commercialize TUKYSA outside U S, Canada, and Europe[8] - Signed worldwide co-development and commercialization agreement with Merck for ladiratuzumab vedotin[8]
Seagen (SGEN) FY Earnings Call Presentation
2025-04-28 13:16
Business Overview and Growth Strategy - Seagen is focused on maximizing the global potential of its three approved products through clinical development and commercial execution[6, 8] - The company aims to advance late-stage programs towards securing approvals for new products[6, 37] - Seagen intends to expand its early-stage pipeline through internal R&D, ADC leadership, and strategic corporate development[6, 44] Product Performance and Sales - Net product sales increased 60% in 3Q20 compared to 3Q19, driven by the addition of PADCEV and TUKYSA to the commercial portfolio[12] - Total revenues for the three months ended September 30, 2020, were $1.1 billion[48] - Total revenues for the nine months ended September 30, 2020, were $1.6 billion[48] - ADCETRIS U S /Canada net sales were $163.3 million for the three months ended September 30, 2020[48] - PADCEV U S net sales were $61.8 million for the three months ended September 30, 2020[48] - TUKYSA U S net sales were $42.4 million for the three months ended September 30, 2020[48] Clinical Development and Regulatory Milestones - A BLA submission for tisotumab vedotin (TV) is planned for 1Q21[38] - PADCEV's EV-201 cohort 2 and EV-301 supplemental BLA is planned in 1Q21[22] - The company is advancing 10 registrational trials across ADCETRIS, PADCEV, and TUKYSA[53] - Ladiratuzumab vedotin (LV) global collaboration with Merck for development and commercialization[5, 43]