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 ...

J.P. Morgan Healthcare Conference Clay Siegall, Ph.D. President and Chief Executive Officer January 11, 2021 2 Key 2020 Accomplishments Set Foundation for Continued Growth CONFIDENTIAL 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 to achieve the noted development and regulatory milestones in 2021 and in future periods; anticipated activities related to the Company's planned and ongoing clin ...

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].

Financial Performance - Seagen reported a 26% growth in net product sales for Q2 2023 compared to the same period in the prior year[82]. - For the six months ended June 30, 2023, total revenues increased to $1,123.6 million, a 22% increase from $924.0 million in the same period of 2022, primarily driven by a 24% increase in net product sales[147]. - Net product sales for the three months ended June 30, 2023, were $543.974 million, a 26% increase compared to $431.714 million in 2022, with ADCETRIS and PADCEV showing significant growth[149]. - Royalty revenues for the six months ended June 30, 2023, increased by 21% to $81.367 million from $67.290 million in 2022, driven by higher net product sales by licensees[154]. - Total costs and expenses for the same period rose to $1,528.8 million, up from $1,190.1 million in 2022, mainly due to higher research and development expenses and increased sales, general, and administrative expenses[148]. - Selling, general and administrative expenses increased by 11% to $243.9 million for the three months ended June 30, 2023, and by 22% to $480.4 million for the six months ended June 30, 2023, driven by higher commercialization efforts and acquisition-related expenses[186]. - Investment and other income, net increased by 461% to $15.1 million for the three months ended June 30, 2023, and by 807% to $29.7 million for the six months ended June 30, 2023[188]. - The provision for income taxes increased to $2.9 million and $7.5 million for the three and six months ended June 30, 2023, respectively, compared to $0.1 million and $1.4 million in the same periods of 2022[191]. - Cash, cash equivalents, and investments totaled $1.3 billion as of June 30, 2023, down from $1.7 billion at the end of 2022[192]. - The company had $1.3 billion in cash, cash equivalents, and investments as of June 30, 2023, alongside total stockholders' equity of $2.6 billion[148]. Drug Approvals and Clinical Trials - PADCEV received accelerated approval from the FDA as a combination therapy for locally advanced or metastatic urothelial cancer, contingent on verification of clinical benefit in the EV-302 trial[85]. - ADCETRIS showed a statistically significant 41% reduction in risk of death in patients with frontline advanced classical Hodgkin lymphoma compared to previous standard care[91]. - TUKYSA demonstrated a confirmed objective response rate of 46.7% in a phase 2 study for HER2-positive metastatic biliary tract cancer[84]. - TUKYSA received FDA approval in January 2023 for use in combination with trastuzumab for adult patients with RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer[101]. - TIVDAK was granted accelerated approval by the FDA in September 2021 for recurrent or metastatic cervical cancer, supported by the innovaTV 204 trial[103]. - ADCETRIS demonstrated a 98% overall response rate and a 93% complete response rate in a phase 2 trial for early-stage classical Hodgkin lymphoma[107]. - The EV-302 trial for PADCEV and pembrolizumab is expected to report topline data by the end of 2023, following completion of enrollment in November 2022[111]. - TUKYSA is undergoing a broad clinical development program, including the HER2CLIMB-02 trial, with topline data expected in Q3 2023[116]. - The phase 3 trial of TIVDAK, called innovaTV 301, completed enrollment in February 2023 and aims to support global regulatory applications[123]. - Interim data from the innovaTV 205 trial indicated a confirmed objective response rate of 41% in patients with recurrent or metastatic cervical cancer who had not received prior systemic therapy, with 16% achieving complete responses[124]. - The phase 2 study of TIVDAK in patients with recurrent or metastatic squamous cell carcinoma of the head and neck demonstrated a confirmed overall response rate of 40%[125]. Mergers and Acquisitions - The Pfizer Merger is set at $229 per share in cash, with over 99% of voted shares in favor, representing approximately 88% of Seagen's outstanding shares[82]. - The company expects the Pfizer Merger to be completed in late 2023 or early 2024, pending regulatory approvals[82]. - The definitive merger agreement with Pfizer involves an acquisition price of $229 per share in cash, with various operational covenants in place[199]. - The Federal Trade Commission issued a Second Request for additional information regarding the Pfizer Merger, extending the waiting period under the Hart-Scott-Rodino Act[82]. - The company expects to incur non-recurring acquisition and transaction fees related to the pending acquisition by Pfizer, including legal and advisory fees[143]. Research and Development - The company plans to submit additional Investigational New Drug applications to the FDA in 2023 for early-stage clinical candidates[128]. - The company is conducting multiple trials for PADCEV across various cancer types, including ongoing trials in frontline metastatic urothelial cancer and muscle invasive bladder cancer[109]. - Research and development expenses rose by 31% to $399.9 million for the three months ended June 30, 2023, compared to $304.3 million in the same period of 2022, driven by higher employee-related and clinical trial costs[175]. - Total research and development expenses for the six months ended June 30, 2023, were $755.9 million, up 26% from $601.9 million in the same period of 2022[175]. - Research and development expenses for the six months ended June 30, 2023 were $755.9 million, with an expected increase in 2023 compared to 2022[202]. - The company has entered into a collaboration with Sanofi to develop multiple novel ADCs, with initial preclinical data showing potent antitumor activity[133]. Market and Economic Factors - The Inflation Reduction Act of 2022 may significantly impact the pharmaceutical industry, including potential price negotiations and penalties for drug manufacturers[140]. - The company is monitoring the ongoing impact of the COVID-19 pandemic on its operations and the ability of collaborators to market and distribute products effectively[144]. - The company expects gross-to-net deductions to increase in 2023 compared to 2022, driven by anticipated growth in gross product sales[152]. - The company expects cost of sales to increase in 2023 compared to 2022 due to net product sales growth and higher anticipated gross profit sharing with collaborators[174]. - Cost of sales increased by 70% to $180.8 million for the three months ended June 30, 2023, compared to $106.1 million in the same period of 2022, primarily due to higher sales and a $47 million inventory write-off[173]. - Third-party costs for disitamab vedotin increased due to higher clinical trial expenses, impacting both the three and six months ended June 30, 2023 compared to 2022[181]. - Net cost-sharing reimbursements from collaborators were $25.7 million and $21.1 million for the three months ended June 30, 2023 and 2022, respectively, and $45.1 million and $44.3 million for the six months ended June 30, 2023 and 2022, respectively[182]. - The company made a $200 million upfront payment to RemeGen for exclusive license rights to disitamab vedotin, with potential milestone payments of up to $2.2 billion based on regulatory and commercialization goals[169]. - The company received an upfront payment of $30 million from Zai Lab in October 2022 for the exclusive collaboration and license agreement for TIVDAK in mainland China, Hong Kong, Macau, and Taiwan[163]. - The company has other collaboration agreements that typically involve upfront cash payments and milestone payments, but it does not control the commercialization of the products generating these milestones[171].

Financial Performance - Seagen reported a 22% growth in both net product sales and total revenue for Q1 2023 compared to the same period last year[81]. - Total revenues for Q1 2023 increased to $519.7 million, up from $426.5 million in Q1 2022, representing a growth of 22% driven by higher net product sales[141]. - Net product sales reached $468.6 million in Q1 2023, a 22% increase from $383.1 million in Q1 2022, with ADCETRIS sales growing by 34% and TIVDAK sales increasing by 71%[143][144]. - Royalty revenues for Q1 2023 were $28.2 million, a 7% increase from $30.2 million in Q1 2022, driven by higher net product sales by licensees[147]. - Collaboration and license agreement revenues increased by 38% to $20.9 million in Q1 2023, compared to $15.2 million in Q1 2022, primarily due to higher royalties from Astellas' sales of PADCEV[150]. - The company reported a net loss from operating activities of $249.6 million for the three months ended March 31, 2023, compared to a loss of $216.8 million in the same period of 2022[184]. - Cash, cash equivalents, and investments totaled $1.5 billion as of March 31, 2023, with total stockholders' equity at $2.7 billion[142]. - The company expects existing financial resources to be sufficient to fund operations for at least the next twelve months[189]. Research and Development - Total research and development expenses rose by 20% to $356 million for the three months ended March 31, 2023, with significant increases in clinical development and manufacturing costs[168]. - Research and development expenses for Q1 2023 were $356.0 million, with an expected increase in investment for the year[192]. - The company anticipates an increase in total research and development expenses in 2023 compared to 2022, primarily due to ongoing product development and employee retention costs[176]. - The company is developing SGN-B7H4V, an ADC for solid tumors, with initial data expected in the second half of 2023[124]. - Disitamab vedotin is being developed under a license agreement with RemeGen, with ongoing phase 2 and planned phase 3 trials for HER2-expressing metastatic urothelial cancer[119]. - Ladiratuzumab vedotin is in phase 1 and phase 2 trials for metastatic breast cancer and select solid tumors, with initial data expected in the second half of 2023[120]. Product Approvals and Collaborations - The FDA granted PADCEV accelerated approval as a combination therapy for adult patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy[81]. - TUKYSA received accelerated approval for adult patients with HER2-positive metastatic colorectal cancer that has progressed after prior chemotherapy[83]. - ADCETRIS received Orphan Drug Exclusivity for its indication in children with previously untreated high-risk Hodgkin lymphoma, providing seven years of market exclusivity[84]. - TIVDAK was granted accelerated FDA approval in September 2021 for recurrent or metastatic cervical cancer, supported by data from the innovaTV 204 trial, with continued approval contingent on confirmatory trials[100]. - An exclusive collaboration with Zai Lab for TIVDAK in mainland China, Hong Kong, Macau, and Taiwan included a $30 million upfront fee and potential milestone payments[102]. - The company has established collaborations with Takeda for ADCETRIS and Astellas for PADCEV, sharing development costs and profits in respective territories[152][153]. - A collaboration with Sanofi aims to develop multiple novel ADCs, with the first preclinical data presented in April 2023, targeting an IND filing in 2023[126]. Future Outlook - The company expects growth in net product sales for 2023 to be primarily driven by ADCETRIS and PADCEV, with ADCETRIS growth supported by its seven indications[130]. - Future growth in net product sales is expected to be supported by sales volume growth and anticipated price favorability in 2023 compared to 2022[145]. - The company plans to fund material cash requirements through current financial resources, accounts receivable, product sales, and collaboration revenues[191]. - The company may require additional capital for ongoing operations, product development, and potential strategic transactions[190]. - The company has no committed sources of funding and may need to scale back operations if unable to raise additional funds[190]. Costs and Expenses - Total costs and expenses rose to $704.2 million in Q1 2023, compared to $559.5 million in Q1 2022, primarily due to increased sales, general, and administrative expenses, as well as higher research and development costs[142]. - Selling, general and administrative expenses increased by 36% to $236.4 million for the three months ended March 31, 2023, reflecting higher commercialization efforts and $30 million in acquisition-related expenses[178]. - Cost of sales increased by 28% to $111.8 million for the three months ended March 31, 2023, driven by higher sales and gross profit sharing, totaling $64 million compared to $52.8 million in the same period of 2022[166]. - Future minimum lease payments as of March 31, 2023, totaled $18.9 million for short-term and $148.4 million for long-term lease liabilities[193]. - Capital expenditures for Q1 2023 amounted to $38.7 million, with expectations to grow to support business expansion, including a $300 million to $350 million investment in a new facility in Everett, Washington through 2024[194]. Market and Economic Conditions - The evolving effects of the COVID-19 pandemic have previously impacted diagnosis rates for ADCETRIS, although these rates have recently returned to pre-pandemic levels[138]. - The company has experienced a favorable effect on gross-to-net deductions in the U.S. market due to high inflation, but future inflation trends remain uncertain[130]. - Gross-to-net deductions are expected to increase in 2023 due to anticipated growth in gross product sales, influenced by government-mandated discounts and rebates[145]. - There have been no material changes to market risk disclosures as of the latest report[198].

Financial Position - As of December 31, 2022, the total assets of Seagen Inc. were $3,674.5 million, a slight decrease from $3,719.6 million in 2021[462] - The company's cash and cash equivalents decreased to $319.9 million in 2022 from $424.8 million in 2021, representing a decline of approximately 24.6%[462] - Short-term investments also decreased to $1,415.1 million in 2022 from $1,735.2 million in 2021, a reduction of about 18.4%[462] - The total stockholders' equity decreased to $2,803.8 million in 2022 from $3,065.1 million in 2021, a decline of approximately 8.5%[462] - Cash, cash equivalents, and restricted cash at the end of 2022 were $323,486,000, down from $424,834,000 at the end of 2021[472] - As of December 31, 2022, total cash, cash equivalents, and restricted cash amounted to $323.5 million, a decrease from $424.8 million in 2021[485] - The gross carrying value of finite-lived intangible assets was $305.7 million as of December 31, 2022, with accumulated amortization of $68.1 million[492] - The total deferred tax assets, net of valuation allowance, decreased to $15.4 million in 2022 from $19.3 million in 2021[564] Revenue and Sales - Total revenues for 2022 were $1,962,412,000, an increase of 24.6% from $1,574,371,000 in 2021[464] - Net product sales reached $1,706,516,000 in 2022, up 23.1% from $1,385,566,000 in 2021[464] - ADCETRIS sales were $839.3 million in 2022, a 19.0% increase from $705.6 million in 2021[537] - PADCEV sales increased to $451.4 million in 2022, representing a 32.8% growth from $339.9 million in 2021[537] - TUKYSA sales were $353.1 million in 2022, a slight increase from $334.0 million in 2021[537] Expenses - Research and development expenses increased to $1,344,361,000 in 2022, compared to $1,228,672,000 in 2021, reflecting a growth of 9.4%[464] - Total costs and expenses for 2022 were $2,575,382,000, up from $2,256,427,000 in 2021, marking a rise of 14.2%[464] - The company reported share-based compensation of $221,297,000 in 2022, an increase from $173,117,000 in 2021[472] - Advertising expenses totaled $114.1 million in 2022, up from $88.8 million in 2021[512] Net Loss - The net loss for 2022 was $610,308,000, an improvement from a net loss of $674,471,000 in 2021[464] - Net loss per share (basic and diluted) for 2022 was $3.30, compared to $3.70 in 2021[464] - The company reported a net loss of $610.3 million for the year ended December 31, 2022, compared to a net loss of $674.5 million in 2021[619] Taxation - The company recorded a tax expense of $8.0 million for 2022, primarily due to taxable profits in the U.S.[559] - The effective tax rate for 2022 was -1.3%, compared to 0.2% in 2021, indicating a shift in tax liabilities[557] - Unrecognized tax benefits rose to $35.2 million in 2022 from $30.3 million in 2021, indicating an increase in uncertainties regarding tax positions[567] Investments and Interest Rates - A hypothetical increase in interest rates by one percent would reduce the fair value of the investment portfolio by $2.4 million as of December 31, 2022[442] - Management estimates a hypothetical decrease of 10% in the effective yield of investments would reduce expected investment income by $4.3 million over the next twelve months[442] - Fair value of short-term investments in U.S. Treasury securities decreased to $1.4 billion in 2022 from $1.7 billion in 2021, a decline of about 19.0%[549] - Total investment and other income, net for 2022 was $10.7 million, compared to $6.4 million in 2021, representing a year-over-year increase of approximately 67.5%[552] Liabilities - The accrued liabilities and other current liabilities rose to $610.6 million in 2022, compared to $454.0 million in 2021, marking an increase of about 34.5%[462] - The company has future obligations related to supply agreements totaling $425.8 million as of December 31, 2022[601] Collaborations and Agreements - The company is focused on advancing a pipeline of novel therapies for solid tumors and blood-related cancers, utilizing its antibody-drug conjugate technology[474] - Collaboration revenues from Takeda for ADCETRIS include royalties based on net sales, with percentages ranging from the mid-teens to mid-twenties[573] - The LV Agreement with Merck included an upfront cash payment of $600 million and potential milestone payments up to $2.6 billion based on clinical trials and sales thresholds[581] - The company entered into a licensing agreement with RemeGen for disitamab vedotin, with an upfront payment of $200 million and potential milestone payments of up to $2.2 billion[593] Stock and Equity - The company recorded $749.9 million in stockholders' equity following the issuance of 5,000,000 shares to Merck at $200 per share, totaling $1.0 billion in proceeds[615] - As of December 31, 2022, the company had 14,870 thousand shares reserved for future issuance, including stock options and RSUs[617] - The weighted average exercise price of stock options outstanding as of December 31, 2022, was $92.62, with 5,417,087 shares remaining[630] Legal Matters - The company is engaged in legal disputes with Daiichi Sankyo regarding ownership of certain technology, with a potential liability estimated between $14 million and $58 million[609] - Daiichi Sankyo incurred $41.8 million in damages for patent infringement related to the '039 Patent from October 20, 2020, to March 31, 2022[613]

Financial Performance - Reported a 17% increase in net product sales for Q3 2022 compared to the prior year, with a year-to-date growth of 22%[75] - Total revenues for the nine months ended September 30, 2022, increased to $1.4 billion, a 27% increase from $1.1 billion in the same period of 2021[138] - Net product sales rose by $227 million or 22%, driven by growth from each of the approved medicines[138] - Net product sales for ADCETRIS grew by 14% to $601.4 million for the nine months ended September 30, 2022, compared to $529.3 million in 2021[140] - PADCEV net product sales increased by 33% to $329.1 million for the nine months ended September 30, 2022, compared to $247.2 million in 2021[140] - Collaboration and license agreement revenues surged by 240% to $80.2 million for the nine months ended September 30, 2022, compared to $23.6 million in 2021[148] - Royalty revenues increased by 6% to $111.2 million for the nine months ended September 30, 2022, compared to $104.5 million in 2021[145] - The company expects growth in net product sales in 2022 compared to 2021, primarily driven by higher sales of each approved product[143] Research and Development - The company plans to submit additional IND applications to the FDA in 2022 and 2023 for early-stage clinical candidates[123] - The company is conducting multiple clinical trials, including phase 3 trials for TIVDAK and TUKYSA in various cancer indications[116][118] - Total research and development expenses for the nine months ended September 30, 2022, were $986.5 million, with an expected increase compared to 2021[190] - Research and development expenses for the three months ended September 30, 2022, decreased by 16% to $384.6 million compared to $459.1 million in 2021, primarily due to the $200.0 million upfront license payment made in 2021[165] Product Approvals and Collaborations - Entered into a corporate transaction for a bispecific technology candidate, enhancing the portfolio of targeted drug therapies[75] - Extended TIVDAK's geographic reach through a new partnership for development and commercialization in mainland China, Hong Kong, Macau, and Taiwan[75] - Presented positive results from PADCEV and TUKYSA pivotal clinical trials, supporting supplemental applications to the FDA for potential label expansion[75] - Announced a collaboration with LAVA Therapeutics for the development of LAVA-1223, with an upfront payment of $50 million and potential milestones and royalties[75] - TUKYSA received Breakthrough Therapy designation from the FDA for use in combination with trastuzumab for HER2-positive colorectal cancer[81] - ADCETRIS demonstrated a 41% reduction in risk of death versus standard care in advanced Hodgkin lymphoma, leading to an update in NCCN Guidelines[81] - PADCEV received regular approval from the FDA in July 2021, expanding its indication for urothelial cancer treatment[87] - ADCETRIS is now approved in over 75 countries worldwide, with ongoing collaborations for global commercialization[85] - TUKYSA received marketing authorization in the EU for HER2-positive breast cancer, valid in all EU countries and several others[92] - The collaboration with Merck for TUKYSA aims to accelerate global availability, covering Asia, the Middle East, and Latin America[93] - TIVDAK received accelerated FDA approval for recurrent or metastatic cervical cancer, supported by the innovaTV 204 trial data[94] - TIVDAK is co-developed with Genmab, with a 50:50 cost and profit sharing agreement, and commercialization rights split between the U.S. and other regions[95] - An exclusive collaboration with Zai Lab for TIVDAK in China included a $30 million upfront fee and shared milestone payments[96] Clinical Trial Results - PADCEV demonstrated a 64.5% confirmed objective response rate in combination with pembrolizumab for advanced urothelial cancer[104] - The ongoing EV-302 trial evaluates PADCEV and pembrolizumab against chemotherapy in metastatic urothelial cancer, with dual primary endpoints of progression-free survival and overall survival[105] - TUKYSA's HER2CLIMB trial showed a 9.1-month improvement in overall survival for patients with brain metastases compared to standard treatment[110] - TUKYSA demonstrated a 38.1% confirmed response rate in the MOUNTAINEER trial for HER2-positive metastatic colorectal cancer after a median follow-up of 20.7 months[114] - The median overall survival for patients in the MOUNTAINEER trial was reported at 24.1 months[114] - TIVDAK showed a 41% confirmed objective response rate in a cohort of 33 patients with recurrent or metastatic cervical cancer who had not received prior systemic therapy[119] Financial Outlook and Expenses - The company anticipates a deceleration in the growth rate of PADCEV and TUKYSA sales in 2022 compared to 2021 due to market penetration limits[127] - The company expects cost of sales to increase in 2022 compared to 2021 due to net product sales growth and higher manufacturing costs[164] - Selling, general and administrative expenses for the nine months ended September 30, 2022, were $604.9 million, reflecting a 20% increase from 2021[176] - Cash used in operating activities for the nine months ended September 30, 2022, was $(374.3) million, compared to $(215.6) million in 2021[182] - The company anticipates capital expenditures for a new facility in Everett, Washington, to be approximately $350 million to $400 million through 2024[192] Corporate Responsibility and Diversity - The company aims to increase women in leadership roles and improve diversity in clinical trials as part of its Corporate Responsibility initiatives[81] COVID-19 Impact - The ongoing COVID-19 pandemic has negatively impacted product sales due to challenges in patient access to healthcare settings and diagnosis rates[135] - The company is monitoring the impact of COVID-19 on its operations and has implemented measures to ensure workforce safety while continuing essential activities[126]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to For the quarterly period ended June 30, 2022 OR Commission file number 0-32405 SEAGEN INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorpor ...

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) SEAGEN INC. (Exact name of registrant as specified in its charter) Delaware 91-1874389 (State or other jurisdiction of incorporation or o ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Table of Contents Washington, D.C. 20549 Form 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 0-32405 SEAGEN INC. (Exact name of registrant as specified in its charter) (State or other Jurisdiction of incorporati ...