Financial Data and Key Metrics Changes - Total revenues for Q3 2020 were $1.1 billion, with year-to-date revenues of $1.6 billion [21] - Product sales reached $267 million in Q3, with year-to-date product sales of $706 million [21] - Collaboration revenues significantly increased to $758 million in Q3, compared to $18 million in the same period of 2019 [22] - The company ended Q3 with $1.7 billion in cash and investments, bolstered by $725 million in upfront payments from Merck [25][26] Business Line Data and Key Metrics Changes - ADCETRIS sales were $163 million in Q3, a 3% decrease from Q3 2019, attributed to the pandemic's impact on new diagnoses [16][18] - PADCEV sales were $62 million in Q3, an 8% increase over Q2 2020, indicating strong adoption in both academic and community settings [19] - TUKYSA generated $42 million in net product revenues in its first full quarter since launch, with strong adoption and reimbursement coverage exceeding expectations [20] Market Data and Key Metrics Changes - The pandemic has led to a 15% decrease in new Hodgkin lymphoma diagnoses, impacting ADCETRIS sales [16][18] - The company is seeing a shift in site of care that negatively affected gross to net pricing for ADCETRIS [17] - The collaboration with Merck is expected to enhance global reach and patient access for TUKYSA and LV [10] Company Strategy and Development Direction - The company aims to invest in clinical development for ADCETRIS, PADCEV, and TUKYSA, while advancing late-stage pipeline products [12] - Strategic collaborations with Merck are focused on co-developing LV and TUKYSA, enhancing the company's market position [10][12] - The company plans to continue expanding its international infrastructure to support TUKYSA's launch in Europe [9] Management's Comments on Operating Environment and Future Outlook - Management expressed concern over the long-term impact of COVID-19 on cancer patient diagnoses and treatment [48][49] - The company remains optimistic about maintaining market share despite the pandemic's challenges [49] - Future guidance for ADCETRIS has been adjusted to $650 million to $660 million due to fewer new patient diagnoses [26] Other Important Information - The company is pursuing legal action against Daichi Sankyo for patent infringement related to a breast cancer drug [13] - Upcoming R&D Day is scheduled for November 16, where the company will discuss its pipeline and development activities [12] Q&A Session Summary Question: Can you comment on ADCETRIS market dynamics and diagnosis rates? - Management noted that product sales have increased year-over-year, but the pandemic has led to fewer patients starting treatment, which is concerning for future diagnoses [48][49] Question: What is the outlook for PADCEV's growth? - Management indicated that the launch has been strong, and while there may be a slight slowdown in growth, they are maintaining guidance and expect significant developments ahead [54][56] Question: Can you provide details on TUKYSA's launch and adoption hurdles? - The company reported strong uptake in both community and academic settings, with ongoing efforts to enhance awareness and access despite COVID-19 challenges [72][73] Question: How does the cash influx from Merck affect capital allocation? - Management emphasized that the priority is to drive existing products into blockbuster status while exploring new drug opportunities and maintaining innovation [89][92]

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]

Summary of Seattle Genetics Conference Call Company Overview - **Company**: Seattle Genetics - **Key Products**: PADCEV, TUKYSA, ADCETRIS - **Recent Approvals**: PADCEV for metastatic bladder cancer, TUKYSA for HER2 positive metastatic breast cancer Core Points and Arguments 1. **Recent Product Approvals**: - PADCEV was approved in December for metastatic bladder cancer, with Q1 sales reaching $34 million. TUKYSA was approved in April, based on positive HER2CLIMB trial results [3][4] - TUKYSA is the first drug approved in the U.S. under Project Orbis, with recent approval in Switzerland [5] 2. **Commercial Strategy**: - Focus on commercializing ADCETRIS, PADCEV, and TUKYSA despite COVID-19 challenges [7] - Plans to expand indications for approved drugs, with ongoing registrational trials for PADCEV in various bladder cancer settings [8][10] 3. **Market Potential**: - Significant unmet need in bladder cancer, with approximately 20,000 patients presenting with metastatic disease annually in the U.S. [12] - Ongoing trials for PADCEV in muscle invasive and non-muscle invasive bladder cancer, as well as other solid tumors [11][13] 4. **Sales Performance**: - ADCETRIS sales in Q1 were approximately $164 million, with guidance for 7% to 11% growth for the year [21][22] - PADCEV's strong launch attributed to high response rates in a high unmet need patient population [27] 5. **COVID-19 Impact**: - Minimal impact on sales due to ADCETRIS being an outpatient therapy; efforts to mitigate COVID-19 effects on business operations have been successful [21][52] - Focus on maintaining clinical trials and supply chain integrity during the pandemic [53][54] 6. **Pipeline and Future Trials**: - Upcoming data expected for cervical cancer trials, with potential for combination therapies in other solid tumors [47][49] - Dual approach to gaining first-line approval for PADCEV through ongoing trials [36][39] 7. **Business Development Strategy**: - Continued interest in business development opportunities, particularly in oncology, but viewed as a "nice to have" rather than a necessity [59][60] Other Important Content - **Regulatory Strategy**: Building capabilities for European market entry, including health technology assessments and KOL engagement [41] - **Sales Team Experience**: The average experience of the sales team is 18 years, which is expected to enhance connections with healthcare providers [44] - **Long-term Planning**: Discussions on potential long-term impacts of COVID-19 on business operations and clinical development [56] This summary encapsulates the key points discussed during the Seattle Genetics conference call, highlighting the company's recent achievements, strategic focus, and market opportunities.

Financial Data and Key Metrics Changes - Total revenues for the first quarter were $234.5 million, with cash and investments around $800 million and no debt [48] - Revenue guidance for the year is projected between $675 million and $700 million for ADCETRIS [48] Business Line Data and Key Metrics Changes - ADCETRIS net sales reached $164 million in the first quarter, up 22% year-over-year, driven by frontline indications in Hodgkin lymphoma and PTCL [21] - PADCEV, approved for locally advanced or metastatic bladder cancer, is expanding its clinical development to include first-line metastatic urothelial cancer [25][30] - TUKYSA, an oral drug for HER2 positive breast cancer, was recently approved and is expected to have a global impact, with ongoing regulatory activities for approvals in Europe and Asia [32][35] Market Data and Key Metrics Changes - ADCETRIS is commercially available in over 70 countries, with global sales exceeding $1 billion for the first time in 2019 [20][22] - PADCEV has shown a 73% objective response rate in the EV103 trial for first-line metastatic urothelial cancer [27] Company Strategy and Development Direction - The company is focused on establishing ADCETRIS as the standard of care in more patients globally and advancing clinical trials [49] - Plans for PADCEV include a strong launch in the US and expanding clinical development programs [50] - TUKYSA's strategy involves working with regulatory agencies for additional approvals and expanding its program in HER2 positive cancers [50] Management's Comments on Operating Environment and Future Outlook - The management acknowledged the challenges posed by COVID-19 but emphasized the commitment to patient care and ongoing clinical trials [17] - The company is optimistic about the future growth of its product portfolio and pipeline, with expectations for continued revenue growth [48][49] Other Important Information - The company has three therapeutic franchises, each with multiple indications, showcasing strong drug development and regulatory expertise [16] - The management highlighted the importance of digital means for commercial activities during the pandemic [18] Q&A Session Summary Question: Were there any questions submitted? - No questions were submitted during the meeting, leading to the conclusion of the session [53][54]

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]

Financial Performance - Total revenues for Q2 2020 were $278 million[6,19] - Net product sales in Q2 2020 increased by 51% to $240 million compared to Q2 2019[18] - ADCETRIS net product sales were $167.5 million in Q2 2020[19] - PADCEV net sales increased 66% from Q1 2020 to Q2 2020[10] - TUKYSA achieved $15.8 million in sales in Q2 2020 following its mid-April approval[10] 2020 Financial Outlook - ADCETRIS U S and Canada net product sales are projected to be $675 to $700 million[27] - PADCEV U S net product sales are projected to be $215 to $235 million[27] - R&D expenses are expected to be $820 to $870 million[27] Clinical Development - Reported positive topline data for Tisotumab Vedotin (TV) in recurrent/metastatic cervical cancer, with a 24% ORR [95% CI: 15.9%-33.3%][36,38]

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]

R&D Day for Investors and Analysts November 16, 2020 Seagen 2020 R&D Day Clay Siegall, Ph.D. President & Chief Executive Officer Roger Dansey, M.D. Chief Medical Officer Shyra Gardai, Ph.D. Executive Director, Immunology Nancy Whiting, Pharm.D EVP, Corporate Strategy Alliances and Communications Megan O'Meara, M.D. VP, Early Stage Development 2 Forward-Looking Statements Certain of the statements made in this presentation are forward looking, such as those, among others, relating to the Company's potential ...

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]

Financial Performance - Seagen reported a 33% growth in net product sales for Q3 2023 compared to the same period in the prior year[86]. - For the nine months ended September 30, 2023, total revenues increased to $1,772.2 million, a 24% increase from $1,434.3 million in the same period in 2022, primarily driven by a 27% increase in net product sales[146]. - Net product sales for the nine months ended September 30, 2023, reached $1,583.3 million, up 27% from $1,242.9 million in the same period in 2022, with significant contributions from ADCETRIS, PADCEV, TUKYSA, and TIVDAK[149]. - Total costs and expenses for the nine months ended September 30, 2023, increased to $2,408.8 million, a 27% increase from $1,893.2 million in the same period in 2022, primarily due to higher research and development expenses[147]. - Royalty revenues for the nine months ended September 30, 2023, increased to $144.9 million, a 30% increase from $111.2 million in the same period in 2022, driven by higher royalties from sales of Polivy and ADCETRIS[153]. - Collaboration and license agreement revenues decreased to $43.9 million for the nine months ended September 30, 2023, a 45% decrease from $80.2 million in the same period in 2022, primarily due to a prior period upfront license payment[156]. - The company expects growth in net product sales in 2023 compared to 2022 to be primarily supported by sales volume growth and to a lesser degree price favorability[151]. - The company anticipates that gross-to-net deductions will increase in 2023 compared to 2022, driven by anticipated growth in gross product sales[151]. - The company expects to incur additional non-recurring acquisition and transaction fees related to the pending acquisition by Pfizer[144]. - The company may need to raise additional capital to support ongoing research, development, and expansion of operations internationally[143]. - Cash, cash equivalents, and investments as of September 30, 2023, totaled $1,236,986 thousand, down from $1,735,070 thousand at the end of 2022[193]. - The company reported an income tax benefit of $0.6 million for Q3 2023, compared to a provision of $2.3 million in Q3 2022[192]. Research and Development - The phase 3 HER2CLIMB-02 trial of TUKYSA met its primary endpoint of progression-free survival in patients with HER2-positive breast cancer[87]. - Data from the innovaTV 301 trial showed a 30% reduction in risk of death for TIVDAK in recurrent or metastatic cervical cancer patients[88]. - The EV-302 trial demonstrated a 53% reduction in risk of death for PADCEV in previously untreated locally advanced or metastatic urothelial cancer[90]. - Seagen initiated a phase 3 trial for disitamab vedotin in combination with pembrolizumab for HER2-positive urothelial cancer[89]. - ADCETRIS received approval in combination with chemotherapy for previously untreated CD30-positive stage III Hodgkin lymphoma based on updated OS results[90]. - Seagen submitted Investigational New Drug applications for three novel targeted cancer therapies in 2023, with plans for one additional IND submission by year-end[91]. - The company has initiated a phase 3 trial, HER2CLIMB-05, evaluating TUKYSA in combination with trastuzumab and pertuzumab for metastatic HER2-positive breast cancer[120]. - The ongoing phase 2 trial of disitamab vedotin is evaluating its efficacy in HER2-expressing metastatic urothelial cancer, with a phase 3 trial initiated in Q3 2023[128]. - Research and development expenses rose by 17% to $449.0 million for Q3 2023 and by 22% to $1.2 billion for the nine months ended September 30, 2023, due to increased clinical trial costs and employee-related expenses[174]. - Research and development expenses for the nine months ended September 30, 2023, were $1,204.9 million, with an expected increase in 2023 compared to 2022[203]. Product Approvals and Collaborations - The European Commission approved the acquisition of Seagen by Pfizer on October 19, 2023, with completion expected in late 2023 or early 2024[86]. - TUKYSA received FDA approval in April 2020 for advanced HER2-positive breast cancer, supported by data from the HER2CLIMB trial[103]. - In January 2023, TUKYSA received accelerated FDA approval for HER2-positive colorectal cancer based on tumor response rates from the MOUNTAINEER trial[105]. - TIVDAK was granted accelerated FDA approval in September 2021 for recurrent or metastatic cervical cancer, supported by data from the innovaTV 204 trial[107]. - TIVDAK was approved by the FDA in September 2021, with U.S. sales co-promoted by the company and Genmab, sharing 50% of sales representatives and costs[161]. - The company received an upfront payment of $30 million from Zai Lab for TIVDAK commercialization in mainland China, Hong Kong, Macau, and Taiwan, with potential future milestone payments and royalties shared with Genmab[162]. - An exclusive collaboration with Zai Lab for TIVDAK in China included a $30 million upfront fee and potential milestone payments[109]. - Disitamab vedotin received FDA Breakthrough Therapy designation in 2020 and is conditionally approved for treating locally advanced metastatic gastric cancer in China[167]. - The company made a $200 million upfront payment to RemeGen for exclusive license rights to disitamab vedotin, with potential milestone payments up to $2.2 billion based on regulatory and commercialization goals[168]. Sales and Market Performance - PADCEV net sales in the U.S. are recorded by the company, which is responsible for all U.S. distribution activities, with costs and profits shared equally with Astellas Pharma[102]. - TUKYSA sales decreased to $47.7 million in Q3 2023 from $61.1 million in Q3 2022, while PADCEV sales decreased to $16.6 million from $22.9 million in the same period[179]. - The company expects 2023 growth in net product sales to be primarily supported by sales volume growth, with ADCETRIS and PADCEV anticipated to be the largest contributors[137]. - ADCETRIS growth in 2023 is expected to be driven by continued use across its seven indications, particularly in frontline advanced Hodgkin lymphoma[137]. - PADCEV's growth is anticipated to be primarily driven by sales in its frontline la/mUC indication in the U.S., with a deceleration in growth for previously-treated indications[137]. - The confirmed objective response rate for TIVDAK was 17.8%, significantly higher than the 5.2% observed with chemotherapy, with a disease control rate of 75.9% compared to 58.2%[125]. - The EV-302 trial for PADCEV and pembrolizumab showed a median overall survival of 31.5 months compared to 16.1 months for chemotherapy, with a 53% reduction in the risk of death[114]. - The safety profile of TIVDAK in the innovaTV 301 trial was consistent with its known safety profile, with no new safety signals observed[125]. - Total third-party costs for clinical stage programs increased to $155.0 million in Q3 2023 from $149.6 million in Q3 2022, reflecting ongoing clinical trial expenses[179]. - Third-party costs for TIVDAK remained flat for Q3 2023 compared to Q3 2022, while costs for ladiratuzumab vedotin increased due to clinical trial expenses[181]. Costs and Expenses - Cost of sales increased by 53% to $165.3 million for Q3 2023 compared to Q3 2022, and by 52% to $457.8 million for the nine months ended September 30, 2023, driven by higher sales and a $47 million inventory write-off[172]. - Selling, general and administrative expenses for the nine months ended September 30, 2023, were $746.1 million, reflecting a 23% increase from $604.9 million in 2022[187]. - Net cost-sharing reimbursements from collaborators decreased from $77.1 million in the nine months ended September 30, 2022, to $68.3 million in 2023[183]. - The gross profit share to collaborators totaled $103.1 million for Q3 2023, up from $71.0 million in Q3 2022, and $249.0 million for the nine months ended September 30, 2023, compared to $189.4 million in the same period of 2022[172]. Acquisition and Market Risks - The pending acquisition by Pfizer is valued at $229 per share, with associated expenses of $3 million and $40 million for Q3 and the nine months ended September 30, 2023, respectively[200]. - The company decided to deprioritize the LV program and agreed to terminate the collaboration with Merck effective October 14, 2023[164]. - The preparation of financial statements requires estimates, assumptions, and judgments that affect reported amounts[208]. - Critical accounting policies for the nine months ended September 30, 2023, were consistent with those in the Annual Report for the year ended December 31, 2022[208]. - There have been no material changes to market risk disclosures as set forth in the Annual Report for the year ended December 31, 2022[209].