This Quarterly Report on Form 10-Q, including the following discussion of our financial condition and results of operations, contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are based on our management's beliefs and assumptions and on information currently available to our management. All statements other than statements of historical facts are "forward-looking statements" for purposes of these provisions, including those relating to future events or our future financial performance and financial guidance. In some cases, you can identify forward-looking statements by terminology such as "may," "might," "will," "should," "expect," "plan," "anticipate," "project," "believe," "estimate," "predict," "potential," "intend" or "continue," the negative of terms like these or other comparable terminology, and other words or terms of similar meaning in connection with any discussion of future operating or financial performance. These statements are only predictions. All forward-looking statements included in this Quarterly Report on Form 10-Q are based on information available to us on the date hereof, and we assume no obligation to update any such forward-looking statements except as required by law. Any or all of our forward-looking statements in this document may turn out to be wrong. Actual events or results may differ materially. Our forward-looking statements can be affected by inaccurate assumptions we might make or by known or unknown risks, uncertainties and other factors. We discuss many of these risks, uncertainties and other factors in this Quarterly Report on Form 10-Q in greater detail under the heading "Part II Item 1A-Risk Factors." We caution investors that our business and financial performance are subject to substantial risks and uncertainties. OverviewSeagen is a biotechnology company that develops and commercializes therapies targeting cancer. We are commercializing ADCETRIS®, or brentuximab vedotin, for the treatment of certain CD30-expressing lymphomas, PADCEV®, or enfortumab vedotin-ejfv, for the treatment of certain metastatic urothelial cancers, and TUKYSA®, or tucatinib, for treatment of certain metastatic HER2-positive breast cancers. We are also advancing a pipeline of novel therapies for solid tumors and blood-related cancers designed to address unmet medical needs and improve treatment outcomes for patients. Many of our programs, including ADCETRIS and PADCEV, are based on our antibody-drug conjugate, or ADC, technology that utilizes the targeting ability of monoclonal antibodies to deliver cell-killing agents directly to cancer cells. InOctober 2020 , we changed our corporate name fromSeattle Genetics, Inc. toSeagen Inc. , reflecting the global expansion of our operations. ADCETRIS® (brentuximab vedotin) ADCETRIS is commercially available in more than 70 countries worldwide. We commercialize ADCETRIS in theU.S. and its territories and inCanada , and we collaborate with Takeda Pharmaceutical Company Limited, orTakeda , to develop and commercialize ADCETRIS on a global basis. Under this collaboration,Takeda has commercial rights in the rest of the world and pays us a royalty. ADCETRIS is approved by theU.S. Food and Drug Administration , or FDA, in six indications. In Hodgkin lymphoma, ADCETRIS is approved as monotherapy for patients whose disease has relapsed and as consolidation therapy following prior treatment, and in combination with chemotherapy for the treatment of patients with previously untreated disease. In T-cell lymphomas, ADCETRIS is approved as monotherapy for patients with relapsed or refractory systemic anaplastic large cell lymphoma, or sALCL, or certain types of cutaneous T-cell lymphoma, and in combination with chemotherapy for patients with previously untreated CD30-expressing peripheral T-cell lymphoma, or PTCL. Beyond our current labeled indications, we are evaluating ADCETRIS in several clinical trials. These include a potentially registration-enabling trial evaluating treatment with ADCETRIS in Hodgkin lymphoma and PTCL patients who are unfit for combination chemotherapy, and a potentially registration-enabling trial evaluating retreatment with ADCETRIS in Hodgkin and T-cell lymphoma patients who progress after a prior response, including in the frontline setting. We have also initiated a phase 3 clinical trial evaluating ADCETRIS in combination with lenalidomide and rituxan in patients with relapsed or refractory diffuse large B-cell lymphoma. In addition, we are evaluating ADCETRIS in combination with nivolumab for Hodgkin and non-Hodgkin lymphoma under a clinical collaboration with Bristol-Myers Squibb Company, or BMS. Nivolumab is a programmed death-1, or PD-1, immune checkpoint inhibitor. InApril 2020 , we and BMS agreed to co-fund an additional cohort in an ongoing trial that will evaluate the combination of ADCETRIS, nivolumab and chemotherapy as first-line therapy in stage I and II Hodgkin lymphoma. PADCEV® (enfortumab vedotin-ejfv) Our second marketed product, PADCEV, is being co-developed and jointly commercialized with Astellas Pharma, Inc., or Astellas. In theU.S. , we and Astellas are jointly promoting PADCEV. In theU.S. , we record net sales of PADCEV and are responsible for all distribution activities. We and Astellas each bear the costs of our own sales organizations in theU.S. , equally share certain other costs associated with commercializing PADCEV in theU.S. , and equally share in any profits realized in theU.S. 18
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PADCEV was granted accelerated approval by the FDA inDecember 2019 for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting. FDA approval of PADCEV was supported by data from the first cohort of patients in a single-arm pivotal phase 2 clinical trial called EV-201. The trial enrolled 125 patients with locally advanced or metastatic urothelial cancer who received prior treatment with a PD-1 or PD-L1 inhibitor and a platinum-based chemotherapy. It is the first FDA approved treatment for these patients. Continued approval may be contingent upon verification and description of clinical benefit in a required confirmatory trial. InSeptember 2020 , we announced that the global phase 3 clinical trial called EV-301, which compared PADCEV to chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor, met its primary endpoint of overall survival, or OS. We plan to submit the EV-301 results to the FDA as the confirmatory trial following PADCEV's accelerated approval inDecember 2019 . EV-301 is also intended to support global registrations. In the trial, PADCEV significantly improved OS, with a 30 percent reduction in risk of death (Hazard Ratio [HR]=0.70; [95 percent Confidence Interval (CI): 0.56, 0.89]; p=0.001). PADCEV also significantly improved progression-free survival, or PFS, a secondary endpoint, with a 39 percent reduction in risk of disease progression or death (HR=0.61 [95 percent CI: 0.50, 0.75]; p<0.00001). For patients in the PADCEV arm of the trial, adverse events were consistent with those listed in theU.S. Prescribing Information, with rash, hyperglycemia, decreased neutrophil count, fatigue, anemia and decreased appetite as the most frequent Grade 3 or greater adverse event(s) occurring in more than 5 percent of patients. InOctober 2020 , we announced positive topline results from the second cohort of patients in the pivotal phase 2 EV-201 trial. The cohort is evaluating PADCEV for patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor and have not received a platinum-containing chemotherapy and are ineligible for cisplatin. Results showed a 52 percent objective response rate, or ORR, [95 percent Confidence Interval (CI): 40.8, 62.4] per blinded independent central review and a median duration of response of 10.9 months. The most frequently reported treatment-related adverse events Grade 3 or greater that occurred in more than 5 percent of patients were: neutropenia, rash, fatigue, increased lipase, diarrhea, decreased appetite, anemia and hyperglycemia. We expect to discuss the data from the second cohort with regulatory authorities. PADCEV is also being investigated in frontline metastatic urothelial cancer and earlier stages of bladder cancer. We and Astellas are conducting a phase 1b/2 clinical trial, called EV-103, that is a multi-cohort, open-label trial of PADCEV alone or in combination with the anti-PD-1 therapy pembrolizumab and/or chemotherapy. The trial is evaluating safety, tolerability and activity in locally advanced and first- and second-line metastatic urothelial cancer, and was expanded to include muscle invasive bladder cancer, or MIBC. InFebruary 2020 , updated results from the trial in patients with previously untreated locally advanced or metastatic urothelial cancer who were ineligible for treatment with cisplatin-based chemotherapy were presented at the 2020 Genitourinary Cancers Symposium. InFebruary 2020 , based on the positive initial results of the EV-103 trial, the FDA granted Breakthrough Therapy designation for PADCEV in combination with pembrolizumab for the treatment of patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting. InApril 2020 , we announced that based on discussions with the FDA, data from the randomized cohort K in the EV-103 trial, along with other data from the EV-103 trial, could potentially support registration under theFDA's accelerated approval pathway. The primary outcome measures are objective response rate and duration of response. In addition to the potential accelerated approval pathway based on the EV-103 trial, we are conducting a global, registrational phase 3 trial, called EV-302, in frontline metastatic urothelial cancer in collaboration with Astellas and a subsidiary of Merck & Co., Inc., or Merck. We, Astellas and Merck are jointly funding EV-302 and the trial is being led by us. EV-302 is an open-label, randomized phase 3 clinical trial evaluating the combination of PADCEV and pembrolizumab versus chemotherapy alone in patients with previously untreated locally advanced or metastatic urothelial cancer. The trial includes metastatic urothelial cancer patients who are either eligible or ineligible for cisplatin-based chemotherapy and is expected to enroll 760 patients. The first patient was dosed in the trial inApril 2020 . The trial has dual primary endpoints of progression-free survival and overall survival and is intended to support global registrations and potentially serve as a confirmatory trial if accelerated approval is granted based on EV-103. InApril 2020 , we and Astellas entered into an agreement with Merck to evaluate PADCEV in MIBC. Merck has amended its ongoing phase 3 KEYNOTE-905/EV-303 registrational trial in cisplatin-ineligible patients with MIBC to include an arm evaluating PADCEV in combination with pembrolizumab. InOctober 2020 , we and Astellas entered into an agreement with Merck to evaluate PADCEV in combination with pembrolizumab in a phase 3 trial to be conducted by Merck in cisplatin-eligible patients with MIBC. 19
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InJanuary 2020 , we and Astellas also initiated a phase 2 clinical trial, called EV-202, to evaluate PADCEV monotherapy in solid tumors that have high-levels of Nectin-4 expression, including non-small cell lung, head and neck, gastric/esophageal and breast cancers. InMarch 2020 , the first patient was dosed in the trial. TUKYSA® (tucatinib) InApril 2020 , TUKYSA received approval from the FDA in combination with trastuzumab and capecitabine for the treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. TUKYSA is an oral, small molecule tyrosine kinase inhibitor, or TKI, that is highly selective for HER2, a growth factor receptor overexpressed in many cancers. The FDA reviewed the application for approval under theOncology Center of Excellence's , or OCE's, Real Time Oncology Review, or RTOR, pilot program. We are also participating in theProject Orbis initiative of the FDA OCE which provides a framework for concurrent submission and review of oncology products among international partners. Under this program we have received approval from the following countries participating in theFDA's Project Orbis initiative:U.S. ,Canada ,Australia ,Singapore , andSwitzerland . InJanuary 2020 , we submitted a Marketing Authorization Application, or MAA, to theEuropean Medicines Agency , or EMA, and the submission was validated, which confirmed it was sufficiently complete to begin the formal review process. FDA approval of TUKYSA was supported by data from the HER2CLIMB trial. HER2CLIMB is a randomized trial evaluating TUKYSA in combination with trastuzumab and capecitabine versus trastuzumab and capecitabine alone in patients with HER2-positive unresectable locally advanced or metastatic breast cancer, including patients with brain metastases. Patients had to have previously received, either separately or in combination, trastuzumab, pertuzumab, and ado-trastuzumab emtansine, or T-DM1. InDecember 2019 , positive results from the HER2CLIMB trial were published in theNew England Journal of Medicine and TUKYSA was granted Breakthrough Therapy designation by the FDA. We are conducting a broad clinical development program of TUKYSA including ongoing and planned trials in earlier lines of breast cancer and in other HER2-positive cancers. InOctober 2019 , we initiated a phase 3 randomized trial, called HER2CLIMB-02, evaluating TUKYSA versus placebo, each in combination with T-DM1, for patients with unresectable locally advanced or metastatic HER2-positive breast cancer, including those with brain metastases, who have had prior treatment with a taxane and trastuzumab. We are also conducting a phase 2 trial, called MOUNTAINEER, evaluating TUKYSA in combination with trastuzumab in patients with HER2-positive, RAS wild-type metastatic colorectal cancer after treatment with first- and second-line standard-of-care therapies. Initial results from 23 patients were presented at the ESMO 2019Congress that demonstrated encouraging antitumor activity. We believe the trial could potentially support an application for accelerated approval in theU.S. We are conducting a phase 2/3 trial, called MOUNTAINEER-02, in combination with trastuzumab, ramucirumab and paclitaxel in second-line HER2-positive metastatic gastroesophageal cancer. We have also initiated a phase 1b trial evaluating TUKYSA in combination with trastuzumab and oxaliplatin based chemotherapy in first-line HER2-positive unresectable or metastatic colorectal, gastric, esophageal and gallbladder cancers. InSeptember 2020 , we entered into a license and collaboration agreement with a subsidiary of Merck, or the TUKYSA Agreement. that granted exclusive rights to Merck to commercialize TUKYSA inAsia , theMiddle East andLatin America and other regions outside of theU.S. ,Canada andEurope . The collaboration is intended to accelerate global availability of TUKYSA. Please refer to Note 2 of the Notes to Our Condensed Consolidated Financial Statements included in Part 1 Item 1 of this Quarterly Report on Form 10-Q for additional information. 20
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Tisotumab Vedotin In collaboration with Genmab A/S, or Genmab, we are developing tisotumab vedotin, which is an ADC targeting tissue factor. We and Genmab are conducting a pivotal phase 2 trial, called innovaTV 204, evaluating single-agent tisotumab vedotin for patients with recurrent and/or metastatic cervical cancer who have relapsed or progressed after standard of care treatment. InSeptember 2020 , data from the innovaTV 204 trial were presented at theEuropean Society for Medical Oncology , or ESMO,Virtual Congress 2020. Results from the trial showed a 24 percent confirmed objective response rate [95 percent Confidence Interval (CI): 15.9 percent-33.3 percent], including 7 patients (7 percent) with a complete response and 17 patients (17 percent) with a partial response by independent central review. After a median follow-up of 10 months, the median DOR was 8.3 months (95 percent CI: 4.2, not reached). The most common treatment-related adverse events (greater than or equal to 20 percent) included alopecia (Grade 1/2 at 38 percent), epistaxis (nose bleeds, Grade 1/2 at 30 percent), nausea (Grade 1/2 at 27 percent), conjunctivitis (Grade 1/2 at 26 percent), fatigue (Grade 1/2 at 24 percent, Grade 3 or higher at 2 percent) and dry eye (Grade 1/2 at 23 percent). Most treatment-related adverse events were Grade 1 or 2 and no new safety signals were reported. One death due to septic shock was considered by the investigator to be related to tisotumab vedotin. Pre-specified adverse events of interest with tisotumab vedotin treatment included ocular events, bleeding and peripheral neuropathy. Ocular adverse events considered to be related to therapy that occurred in patients were mostly mild to moderate (Grade 1 at 25 percent, Grade 2 at 27 percent, Grade 3 at 2 percent) of which a majority of the events resolved (86 percent) and were managed with an eye care plan. Bleeding events considered to be related to therapy that occurred in patients were mostly mild (Grade 1 at 34 percent, Grade 2 at 3 percent, Grade 3 at 2 percent) of which a majority of the events resolved (90 percent). The most common bleeding events included Grade 1 epistaxis (28 percent). Peripheral neuropathy events considered to be related to therapy were mostly mild to moderate (Grade 1 at 17 percent, Grade 2 at 9 percent, Grade 3 at 7 percent) and managed with dose modifications. Resolution of peripheral neuropathy was limited by follow-up period. Based on the positive results, the companies plan to submit a Biologics License Application, or BLA, to the FDA under theFDA's accelerated approval pathway. We are also conducting a phase 2 clinical trial, called innovaTV 205, evaluating tisotumab vedotin as monotherapy and in combination with certain other anti-cancer agents for first-line treatment of patients with recurrent or advanced cervical cancer. Additionally, we are conducting a phase 2 clinical trial, called innovaTV 207, for patients with relapsed, locally advanced or metastatic solid tumors and a phase 2 clinical trial, called innovaTV 208, for patients with platinum-resistant ovarian cancer. Ladiratuzumab Vedotin Our pipeline also includes ladiratuzumab vedotin, orLV , an ADC targeting LIV-1, which is currently being evaluated in phase 1 and phase 2 clinical trials both as monotherapy and in combination with other agents for patients with metastatic breast cancer and select solid tumors with high LIV-1 expression. InSeptember 2020 , we and a subsidiary of Merck entered into a license and collaboration agreement, or the LV Agreement, under which the companies will jointly develop and share future costs and profits worldwide forLV . Merck made an upfront payment to us of$600.0 million , and inOctober 2020 , Merck made a$1.0 billion equity investment in 5,000,000 shares of our common stock at$200 per share. In addition, we are eligible to receive up to$850.0 million in milestone payments upon the initiation of certain clinical trials and regulatory approval in certain major markets, and up to an additional$1.75 billion in milestone payments upon the achievement of specified annual global net sales thresholds ofLV , for an aggregate$2.6 billion . Please refer to Note 2 of the Notes to Our Condensed Consolidated Financial Statements included in Part 1 Item 1 of this Quarterly Report on Form 10-Q for additional information. Other clinical and early-stage product candidates We are advancing multiple earlier stage programs that employ our proprietary technologies. InJune 2020 , the first patient was dosed in a phase 1 clinical trial of our investigational agent SEA-TGT, also known as SGN-TGT, an anti-TIGIT antibody for patients with solid tumors and lymphomas. TIGIT (T-cell immune receptor with Ig and ITIM domains) is an inhibitory immune receptor that is emerging as a clinically relevant immuno-oncology target. SEA-TGT is a nonfucosylated human IgG1 antibody that uses our proprietary Sugar Engineered Antibody, or SEA, technology. We also announced the dosing of the first patient in a phase 1 clinical trial evaluating our investigational agent SGN-B6A, an ADC targeting integrin beta-6, which is overexpressed in numerous solid tumors and has been demonstrated to be a negative prognostic indicator across a diverse range of cancers. 21
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Antibody-Drug Conjugate technology license agreements We have active technology license agreements for our ADC technology with a number of biotechnology and pharmaceutical companies, includingAbbVie Biotechnology Ltd. , or AbbVie;Genentech, Inc. , a member of the Roche Group, orGenentech ;GlaxoSmithKline LLC , or GSK; andProgenics Pharmaceuticals Inc , as well as collaboration agreements with Astellas and Genmab.Genentech and GSK have ADCs using our technology in late-stage clinical trials. InJune 2019 ,Genentech received accelerated approval from the FDA and, inJanuary 2020 , received conditional marketing authorization from theEuropean Commission for Polivy® (polatuzumab vedotin-piic), an ADC that uses our technology, to treat patients with relapsed or refractory diffuse large B-cell lymphoma. InAugust 2020 , GSK received accelerated approval from the FDA and conditional marketing authorization from theEuropean Commission for Blenrep™ (belantamab mafodotin-blmf), an ADC developed by GSK that uses our technology, for treatment of patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent. Under our ADC license agreements withGenentech and GSK, these events triggered milestone payments to us and we are also entitled receive royalties on net sales of Polivy and Blenrep worldwide. COVID-19 We are continuing to closely monitor the impact of the evolving effects of the COVID-19 pandemic on our business and are taking proactive efforts designed to protect the health and safety of our workforce, patients and healthcare professionals, and to continue our business operations and advance our goal of bringing important medicines to patients as rapidly as possible. We have implemented measures designed to protect the health and safety of our workforce, including a mandatory work-from-home policy for employees who can perform their jobs offsite. We are continuing essential research, manufacturing, and laboratory activities on site and maintain a number of additional precautionary measures designed to protect these onsite employees, such as temperature checks, screening protocols, masks, social distancing, contact tracing and making testing available. In the conduct of our business activities, we are also taking actions designed to protect the safety of patients and healthcare professionals. Among other actions, our field-based personnel have paused most in-person customer interactions in healthcare settings and have been using primarily electronic communications to support healthcare professionals and patients. In addition, following guidance from relevant authorities, our field-based personnel are engaging in limited in-person interactions where state and local laws and regulations allow, the institution or office is accepting in-person interactions and our field-based personnel are comfortable engaging in-person with healthcare providers. We believe that the measures we have implemented are appropriate and are helping to reduce transmission of COVID-19, and we will continue to monitor conditions and related guidance from governmental authorities and adjust our activities as appropriate. Outlook While we anticipate that sales of ADCETRIS will continue to increase, we expect lower sales growth for ADCETRIS in 2020 as compared to sales growth in 2019. In addition, impacts associated with the COVID-19 pandemic appear to be reducing the rate of Hodgkin lymphoma diagnoses, and we are also experiencing an increase in gross-to-net deductions that we believe is due to a shift in the locations where ADCETRIS is administered, which has increased the proportion of ADCETRIS sales through the federal 340B drug discount program. All of these factors appear to be contributing to the slower growth of ADCETRIS sales in 2020 as compared to 2019. We expect that, going forward, our ability to maintain or continue to grow our ADCETRIS sales, if at all, will depend primarily on our ability to establish or demonstrate to the medical community the value of ADCETRIS and its potential advantages compared to existing and future therapeutics in its approved indications, including in the frontline Hodgkin lymphoma indication, and the extent to which physicians make prescribing decisions with respect to ADCETRIS. Other important factors affecting our ADCETRIS sales include the incidence flow of patients eligible for treatment in ADCETRIS' approved indications, the extent to which coverage and adequate levels of reimbursement for ADCETRIS are available from governments and other third-party payors, the impact of any healthcare reform measures that may be adopted in the future, including measures that could potentially result in more rigorous coverage criteria and additional downward pressure on the price that we receive for ADCETRIS, increasing competition from competing therapies including pembrolizumab in multiple indications, including in the relapsed or refractory classical Hodgkin lymphoma indication, impacts resulting from the evolving effects of the COVID-19 pandemic including lower diagnosis rates, and the potential future approval of ADCETRIS in any additional indications. For these reasons, we cannot assure you that ADCETRIS sales will continue to grow or that we can maintain sales of ADCETRIS at or near current levels. In addition, as a result of these and other factors, our future ADCETRIS product sales can be difficult to accurately predict from period to period. 22
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Our ability to realize the anticipated benefits from our investment in PADCEV is subject to a number of risks and uncertainties, including our and Astellas' ability to successfully jointly market and commercialize PADCEV in theU.S. in its approved indication, the extent to which we and Astellas are able to obtain regulatory approvals of PADCEV in additional indications in theU.S. , including in the frontline metastatic urothelial cancer setting, and in territories outside theU.S. , our ability and Astellas' ability to successfully comply with rigorous post-marketing requirements, including obtaining theFDA's agreement as to the confirmation of clinical benefit of PADCEV based on the results of the EV-301 clinical trial, the acceptance of PADCEV by the medical community and patients, the extent to which physicians make prescribing decisions with respect to PADCEV, the incidence flow of patients eligible for treatment in PADCEV's approved indication, the duration of therapy for patients receiving PADCEV, the extent to which coverage and adequate levels of reimbursement for PADCEV are available from governments and other third-party payors, the impact of any healthcare reform measures that may be adopted in the future, including measures that could potentially result in more rigorous coverage criteria and additional downward pressure on the price that we receive for PADCEV, potential competition from competing therapies, the impact of conducting launch activities virtually during the COVID-19 pandemic and other impacts resulting from the evolving effects of the COVID-19 pandemic including potential negative impacts of reduced cancer diagnosis rates. In addition, due to the lack of significant historical sales data and these factors, PADCEV sales are currently difficult to predict from period to period. Our ability to realize the anticipated benefits of our investment in TUKYSA is subject to a number of risks and uncertainties, including our and Merck's ability to successfully launch, market and commercialize TUKYSA in our respective territories in its approved indication, the extent to which we and Merck are able to obtain regulatory and other required governmental and pricing and reimbursement approvals of TUKYSA in additional territories, including in theEuropean Union , the extent to which we and Merck are able to obtain regulatory approvals of TUKYSA in additional indications, including earlier lines of breast cancer and other HER2-positive cancers, the acceptance of TUKYSA by the medical community and patients, competition from other therapies, our and Merck's ability to accurately predict and supply product demand, the extent to which coverage and reimbursement will be available from governments and other third-party payors, our capacity to effectively commercialize a product outside of theU.S. , the impact of conducting launch activities virtually during the COVID-19 pandemic and other impacts resulting from the evolving effects of the COVID-19 pandemic including potential negative impacts of reduced cancer diagnosis rates. In addition, due to the lack of significant historical sales data and these factors, TUKYSA sales are currently difficult to predict from period to period. The biopharmaceutical industry and the markets in which we operate are intensely competitive. Many of our competitors are working to develop or have commercialized products similar to those we market or are developing. Drug prices are under significant scrutiny and we expect drug pricing and other healthcare costs to continue to be subject to intense political and societal pressures on a global basis. For example, inJuly 2020 ,President Trump announced four Executive Orders related to reducing prescription drug prices and we expect that drug pricing will continue to be subject to close scrutiny by federal, state and foreign governments. In addition to pricing actions and other measures being taken worldwide designed to reduce healthcare costs and limit the overall level of government expenditures, our sales and operations could also be affected by other risks of doing business internationally. We expect that amounts earned from our collaboration agreements, including royalties, will continue to be an important source of our revenues and cash flows. These revenues will be impacted by future development funding and the achievement of development, clinical and commercial success by our collaborators under our existing collaboration and license agreements, including our ADCETRIS collaboration withTakeda , our PADCEV collaboration with Astellas, and our TUKYSA andLV collaborations with Merck, as well as by entering into potential new collaboration and license agreements. Our ongoing research, development, manufacturing and commercial activities will require substantial amounts of capital and may not ultimately be successful. We expect that we will incur substantial expenses, and we will require significant financial resources and additional personnel in order to advance the development of, to pursue, obtain and maintain regulatory approvals for, and to commercialize our products and product candidates, and expand our pipeline. In addition, we may pursue new operations or continue the expansion of our existing operations, including with respect to our plans to build a commercial infrastructure inEurope and to otherwise continue to expand our operations internationally. As a result, we may need to raise additional capital, and our operating expenses may fluctuate as a result of such activities. We may also incur milestone payment obligations to certain of our licensors as our product candidates progress through clinical trials towards potential commercialization. 23
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We are closely evaluating the impacts of the evolving effects of the COVID-19 pandemic on our ability and the ability of our collaborators to effectively market, sell and distribute our products and to develop our products and product candidates. While our field-based personnel are engaging in limited in-person interactions, our field-based personnel are primarily using electronic communication, such as emails, phone calls and video conferences. Many healthcare professionals that we normally call on are working a greater proportion of their working schedule from home and are facing additional demands on their time during the ongoing COVID-19 pandemic. We are experiencing increased competition for virtual appointments with healthcare professionals and are experiencing a significant reduction in the number of interactions our sales personnel are having with physicians. We expect the different quality of electronic interactions as compared with in-person interactions, as well as the reduced quantity of interactions during the COVID-19 pandemic, to reduce the effectiveness of our sales personnel, as well as those of our collaborators, which could negatively affect our product sales and those of our collaborators, as well as physician awareness of our products. With respect to PADCEV and TUKYSA specifically, we have not launched a product using primarily virtual communication channels in the past and cannot predict the effects that this approach will ultimately have on demand for TUKYSA or PADCEV. However, we believe that the need to conduct these activities virtually is negatively impacting our ability to connect with key customers, including those familiar with competitive products, and our ability to conduct payor engagements. We face a number of challenges that will limit our ability to fully resume in-person interactions for the foreseeable future, including increasing COVID-19 infection rates in many states, the potential for more severe outbreaks, the need to navigate varying restrictions for entering healthcare facilities and employee childcare obligations during virtual school sessions. In addition, the effects of the COVID-19 pandemic continue to evolve rapidly, and we may subsequently be forced to, or subsequently determine that we should, resume a more restrictive remote work model, whether as a result of further spikes or surges in COVID-19 infection, positivity or hospitalization rates or otherwise. Moreover, the long-term effects of the COVID-19 pandemic are also unknown and it is possible that following the pandemic, healthcare institutions could alter their policies with respect to in person visits by pharmaceutical company representatives. COVID-19 related restrictions could also present product distribution challenges as we utilize recently initiated distribution channels for TUKYSA. We also expect that the conversion of medical conferences to a virtual format may reduce our ability to effectively disseminate scientific information about our products, which may result in decreased physician awareness of our products, their approved indications and their efficacy and safety. The evolving effects of the COVID-19 pandemic may also negatively affect our product sales due to challenges in patient access to healthcare settings, significant increases in unemployment and the resulting loss of individual health insurance coverage, and inability to access government healthcare programs due to backlogs or inability of government agencies to process additional applications, some or all of which appear to be affecting diagnosis rates and may affect side effect management and course of treatment and increase enrollment in our patient support programs. With respect to ADCETRIS specifically, impacts associated with the COVID-19 pandemic appear to be reducing the rate of Hodgkin lymphoma diagnoses, which appears to be contributing to the slower growth of ADCETRIS sales in 2020 as compared to 2019. In addition, we have observed lower than expected levels of our research and development spending, in part as a result of the COVID-19 pandemic. This includes some delays in clinical trial enrollment as well as reduced travel due to the conversion of medical and scientific meetings to virtual format. While we do not at this time anticipate the need to revise our publicly reported projected clinical milestone dates as a result of the effects of the COVID-19 pandemic, there may be some impacts to our clinical study timelines, which, depending upon the duration and severity of the evolving effects of the COVID-19 pandemic, could ultimately delay data availability. In addition, many of our non-essential on site research activities are currently significantly reduced as a result of the COVID-19 pandemic, which may negatively impact the number of investigational new drug application, or IND, candidates entering our clinical pipeline in future years. The extent to which the risks and evolving effects of the COVID-19 pandemic impact our business, our ability to generate sales of and revenues from our approved products, and our clinical development and regulatory efforts will depend on future developments that are highly uncertain and cannot be predicted with confidence, such as the ultimate duration and severity of the pandemic, government actions, such as travel restrictions, quarantines and social distancing requirements in theU.S. and in other countries, business closures or business disruptions and the effectiveness of actions taken in theU.S. and in other countries to contain and treat the disease. For more information on the risks and uncertainties associated with the evolving effects of the COVID-19 pandemic on our business, our ability to generate sales of and revenues from our approved products, and our clinical development and regulatory efforts, see "Part II Item 1A-Risk Factors." Because of the above and other factors, our results of operations may vary substantially from year to year and from quarter to quarter and, as a result, we believe that period to period comparisons of our operating results may not be meaningful and should not be relied upon as being indicative of our future performance. 24
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Financial summary For the nine months endedSeptember 30, 2020 , our total revenues increased to$1.6 billion , compared to$626.9 million for the same period in 2019. This growth was driven by$725.0 million upfront license revenue recognized in the third quarter of 2020 related to theLV and TUKYSA agreements with Merck, theU.S. launches of PADCEV beginning inDecember 2019 and TUKYSA inApril 2020 , respectively, as well as higher ADCETRIS net product sales and royalty revenues. For the nine months endedSeptember 30, 2020 , total costs and expenses increased to$1.1 billion , compared to$809.0 million for the same period in 2019. This reflected higher cost of sales, higher selling, general and administrative expenses, and higher research and development expenses. As ofSeptember 30, 2020 , we had$1.7 billion in cash, cash equivalents and investments and$2.3 billion in total stockholders' equity. Results of operations Net product sales Three months ended September 30, Nine months ended September 30, (dollars in thousands) 2020 2019 % Change 2020 2019 % Change ADCETRIS$ 163,263 $ 167,582 (3) %$ 494,851 $ 461,563 7 % PADCEV 61,849 - NM 153,485 - NM TUKYSA 42,382 - NM 58,137 - NM Net product sales$ 267,494 $ 167,582 60 %$ 706,473 $ 461,563 53 % NM: No amount in comparable period or not a meaningful comparison. Our net product sales grew 60% and 53% during the three and nine months endedSeptember 30, 2020 , respectively, compared to the prior year periods. We began commercializing PADCEV and TUKYSA following FDA approvals inDecember 2019 andApril 2020 , respectively. ADCETRIS net product sales declined slightly for the three months endedSeptember 30, 2020 from the comparable period in 2019. ADCETRIS net product sales increased for the nine months endedSeptember 30, 2020 from the comparable period in 2019, due to higher sales volumes and the effect of price increases during the current year period. While we expect growth in net product sales in 2020 from 2019, primarily driven by the recent launches of PADCEV and TUKYSA, as well as continued growth in ADCETRIS net product sales, we also expect lower net product sales growth for ADCETRIS in 2020 as compared to growth in 2019. Refer to "Overview-Outlook" above for additional information. Gross-to-net deductions, net of related payments and credits, were as follows: Distribution fees, Rebates and product returns (in thousands) chargebacks and other Total Balance as of December 31, 2019$ 38,116 $ 7,538$ 45,654 Provision related to current period sales 256,777 21,126 277,903 Adjustment for prior period sales (1,244) - (1,244) Payments/credits for current period sales (226,997) (12,664) (239,661) Payments/credits for prior period sales (30,119) (1,666) (31,785) Balance as of September 30, 2020$ 36,533 $ 14,334$ 50,867 Government-mandated rebates and chargebacks are the most significant component of our total gross-to-net deductions and the discount percentage has been increasing. These discount percentages increased during the nine months endedSeptember 30, 2020 as a result of price increases for ADCETRIS that we instituted that exceeded the rate of inflation. The most significant portion of our gross-to-net accrual balances as ofSeptember 30, 2020 and 2019 was for Medicaid rebates. We expect future gross-to-net deductions to fluctuate based on the volume of purchases eligible for government mandated discounts and rebates, as well as changes in the discount percentage which is impacted by potential future price increases, the rate of inflation, and other factors. We expect gross-to-net deductions to increase in 2020 as compared to 2019, driven by anticipated growth in our gross product sales. 25
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Royalty revenues Royalty revenues primarily reflect royalties earned under the ADCETRIS collaboration withTakeda . These royalties include commercial sales-based milestones and sales royalties. Sales royalties are based on a percentage ofTakeda's net sales of ADCETRIS, with rates that range from the mid-teens to the mid-twenties based on annual net sales tiers.Takeda bears third-party royalty costs owed on its sales of ADCETRIS. This amount is included in royalty revenues. Royalty revenues also reflect, to a lesser extent, amounts fromGenentech earned on net sales of Polivy beginning in 2019. Three months ended September 30, Nine months ended September 30, (dollars in thousands) 2020 2019 % Change 2020 2019 % Change Royalty revenues$ 35,924 $ 27,261 32 %$ 87,520 $ 66,218 32 % Royalty revenues increased for the three and nine months endedSeptember 30, 2020 from the comparable period in 2019, primarily due to growth inTakeda net sales of ADCETRIS in its territories, as well as higher Roche net sales of Polivy, which began in the second quarter of 2019. We expect that royalty revenues will decrease in 2020 as compared to 2019, reflecting the recognition in the fourth quarter of 2019 of a$40.0 million sales-based milestone earned fromTakeda based on its achievement of an annual ADCETRIS net sales milestone. We expect higher anticipated royalties for ADCETRIS and Polivy in 2020 as compared to 2019. Collaboration and license agreement revenues Collaboration and license agreement revenues reflect amounts earned under certain of our license and collaboration agreements. These revenues reflect the earned portion of payments received by us for technology access and maintenance fees, milestone payments and reimbursement payments for research and development support that we provide to our collaborators. Collaboration and license agreement revenues by collaborator were as follows: Three months ended September 30, Nine months ended September 30, (dollars in thousands) 2020 2019 % Change 2020 2019 % Change Merck$ 725,000 $ - NM$ 725,000 $ - NM Takeda 7,013 17,720 (60) % 22,925 89,859 (74) % Other 26,300 700 NM 32,325 9,269 249 % Total collaboration and license agreement revenues$ 758,313 $ 18,420 NM$ 780,250 $ 99,128
NM
NM: No amount in comparable period or not a meaningful comparison.
Collaboration and license agreement revenues from Merck included license revenues of$725.0 million related to the LV Agreement and the TUKYSA Agreement for the three and nine months endedSeptember 30, 2020 . InOctober 2020 , upon closing of the sale of the shares to Merck under the stock purchase agreement we entered into with Merck in connection with the LV Agreement, we will record additional Merck collaboration and license revenues for$250.1 million for the quarter and year endingDecember 31, 2020 . Refer to Note 2 for additional information. Collaboration and license agreement revenues fromTakeda fluctuate based on changes in reimbursement funding under the ADCETRIS collaboration, which are impacted by the activities each party is performing under the collaboration agreement at a given time. Additionally, we receive reimbursement for the cost of drug product supplied toTakeda for its use, the timing of which fluctuates based onTakeda's product supply needs. Collaboration revenues fromTakeda can also fluctuate based on the achievement of milestones byTakeda . Collaboration revenues fromTakeda for the three and nine months endedSeptember 30, 2020 decreased compared to the comparable periods in 2019, primarily as a result of regulatory milestones achieved byTakeda in 2019 totaling$37.5 million during the nine months endedSeptember 30, 2019 , respectively, and the completion of theTakeda performance period inNovember 2019 . Other collaboration and license agreement revenues increased for the three and nine months endedSeptember 30, 2020 as compared to the comparable periods in 2019 primarily due to recognition of two regulatory milestones achieved by GlaxoSmithKline in the third quarter of 2020. 26
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We expect our collaboration and license agreement revenues in 2020 to increase substantially compared to 2019, driven by the revenue recognized from the Merck agreements. Our collaboration and license agreement revenues are impacted by the term and duration of those agreements and by progress-dependent milestones, annual maintenance fees, and reimbursement of materials and support services. Collaboration and license agreement revenues may vary substantially from year to year and quarter to quarter depending on the progress made by our collaborators with their product candidates, the level of support we provide to our collaborators, the timing of milestones achieved and our ability to enter into potential additional collaboration and license agreements. Collaboration agreements Takeda ADCETRIS collaboration We have an agreement withTakeda for the global co-development of ADCETRIS and the commercialization of ADCETRIS byTakeda in its territory. We have commercial rights for ADCETRIS in theU.S. and its territories and inCanada .Takeda has commercial rights in the rest of the world. Under the collaboration, we andTakeda can each conduct development activities and equally co-fund the cost of certain mutually agreed development activities. We recognize payments fromTakeda , including progress-dependent development and regulatory milestone payments, reimbursement for drug supplied, and net development cost reimbursement payments, as collaboration and license agreement revenues upon transfer of control of the goods or services over the development period. When the performance of development activities under the collaboration results in us making a reimbursement payment toTakeda , that payment reduces collaboration and license agreement revenues. We also recognize royalty revenues based on a percentage ofTakeda's net sales of ADCETRIS in its territories, ranging from the mid-teens to the mid-twenties based on annual net sales tiers, as well as sales-based milestones.Takeda bears a portion of third-party royalty costs owed on its sales of ADCETRIS, which is included in royalty revenues. Costs associated with co-development activities are included in research and development expense. As ofSeptember 30, 2020 , we had achieved milestone payments totaling$157.5 million related to regulatory and commercial progress byTakeda. As ofSeptember 30, 2020 , total future potential milestone payments to us under this collaboration could total$77.0 million . Of that amount, up to approximately$7.0 million relates to the achievement of development milestones, up to$70.0 million relates to the achievement of regulatory milestones. In addition, we recognize royalty revenues, where royalties are based on a percentage ofTakeda's net sales of ADCETRIS in its licensed territories, with percentages ranging from the mid-teens to the mid-twenties based on annual net sales tiers, and sales-based milestones.Takeda bears a portion of third-party royalty costs owed on its sales of ADCETRIS, which is included in royalty revenues. Astellas PADCEV collaboration We have a collaboration agreement withAgensys, Inc. , which subsequently became an affiliate of Astellas, to jointly research, develop and commercialize ADCs for the treatment of several types of cancer. The collaboration encompasses combinations of our ADC technology with fully-human antibodies developed by Astellas to proprietary cancer targets. Under this collaboration, we and Astellas are co-funding all development costs for PADCEV. We rely on Astellas to supply PADCEV for commercial sales and for our clinical trials, and Astellas oversees the manufacturing supply chain for PADCEV. Costs associated with co-development activities are included in research and development expense. In 2018, we and Astellas entered into a joint commercialization agreement to govern the global commercialization of PADCEV: •In theU.S. , we and Astellas jointly promote PADCEV. We record sales of PADCEV in theU.S. and are responsible for allU.S. distribution activities. The companies each bear the costs of their own sales organizations in theU.S. , equally share certain other costs associated with commercializing PADCEV in theU.S. , and equally share in any profits realized in theU.S. •Outside theU.S. , we have commercialization rights in all countries inNorth and South America , and Astellas has commercialization rights in the rest of the world, includingEurope ,Asia ,Australia andAfrica . The agreement is intended to provide that we and Astellas will effectively equally share in costs incurred and any profits realized in all of these markets. Cost and profit sharing inCanada , theUnited Kingdom ,Germany ,France ,Spain andItaly will be based on product sales and costs of commercialization. In the remaining markets, the commercializing party will bear costs and will pay the other party a royalty rate applied to net sales of the product based on a rate intended to approximate an equal profit share for both parties. Astellas or its affiliates are responsible for manufacturing PADCEV for development and commercial use. However, we are responsible for packaging and labeling in countries in which we sell PADCEV. In addition, if the parties determine that a second source is required, we will be responsible for establishing such second source whether internally or through a third party. 27
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Genmab tisotumab vedotin collaboration We have an agreement with Genmab to develop and commercialize ADCs for the treatment of several types of cancer, under which we previously exercised a co-development option for tisotumab vedotin. InOctober 2020 , we and Genmab entered into a joint commercialization agreement to govern the global commercialization of tisotumab vedotin, if we are successful in obtaining any regulatory approvals of tisotumab vedotin: •In theU.S. , we and Genmab will co-promote tisotumab vedotin. We will record sales of tisotumab vedotin in theU.S. and are responsible for leadingU.S. distribution activities. The companies will each hire and maintain 50% of the sales representatives and medical science liaisons, equally share those and certain other costs associated with commercializing tisotumab vedotin in theU.S. , individually bear the costs of certain other personnel in theU.S. , and equally share in any profits realized in theU.S. •Outside theU.S. , we have commercialization rights in the rest of the world except forJapan , where Genmab has commercialization rights. InEurope ,China , andJapan , we and Genmab equally share 50% of the costs associated with commercializing tisotumab vedotin as well as any profits realized in these markets. In markets outside theU.S. other thanEurope ,China , andJapan , aside from certain costs specified in the agreement, we are solely responsible for all costs associated with commercializing tisotumab vedotin and will pay Genmab a royalty based on a percentage of aggregate net sales ranging from the mid-teens to mid-twenties. Costs associated with co-development activities are included in research and development expense. Merck LV collaboration InSeptember 2020 , we entered into the LV Agreement with a subsidiary of Merck. We will pursue a broad joint development program evaluatingLV as monotherapy and in combination with Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in triple-negative breast cancer, hormone receptor-positive breast cancer and other LIV-1-expressing solid tumors. Under the terms of the LV Agreement, we granted Merck a co-exclusive worldwide development and commercialization license forLV , and agreed to jointly develop and commercializeLV on a worldwide basis. We received an upfront cash payment of$600.0 million , and we are eligible to receive up to$850.0 million in milestone payments upon the initiation of certain clinical trials and regulatory approval in certain major markets, and up to an additional$1.75 billion in milestone payments upon the achievement of specified annual global net sales thresholds ofLV . Each company is responsible for 50% of global costs to develop and commercializeLV and will receive 50% of potential future profits. In connection with the LV Agreement, we entered into a stock purchase agreement with Merck inSeptember 2020 , pursuant to which we agreed to issue and sell, and Merck agreed to purchase 5,000,000 newly-issued shares of our common stock, at a purchase price of$200 per share, for an aggregate purchase price of$1.0 billion , referred to as the Purchase Agreement. We closed the Purchase Agreement onOctober 27, 2020 following the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. We recognized license revenue of$600.0 million during the three and nine months endedSeptember 30, 2020 associated with the LV Agreement, and we recognize such cost sharing proportionately with the performance of the underlying activities, while recording Merck's reimbursement of our expenses as a reduction of research and development expenses. Merck TUKYSA collaboration InSeptember 2020 , we entered into the TUKYSA Agreement with a subsidiary of Merck. We granted exclusive rights to commercialize TUKYSA inAsia , theMiddle East andLatin America and other regions outside of theU.S. ,Canada andEurope . Under the terms of the TUKYSA Agreement, Merck is responsible for marketing applications for approval in its territory, supported by the positive results from the HER2CLIMB clinical trial. We retained commercial rights in, and will record sales in, theU.S. ,Canada andEurope . Merck is also co-funding a portion of the TUKYSA global development plan, which encompasses several ongoing and planned trials across HER2-positive cancers. We will continue to lead ongoing TUKYSA global development operational execution. Merck will solely fund and conduct country-specific clinical trials necessary to support anticipated regulatory applications in its territories. We received an upfront cash payment from Merck of$125.0 million and also received$85.0 million in prepaid research and development funding to be applied to Merck's global development cost sharing obligations. We are eligible to receive progress-dependent milestone payments of up to$65.0 million , and are entitled to receive tiered royalties on sales of TUKYSA by Merck that begin in the low twenty percent range and escalate based sales volume by Merck in its territory. 28
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We recognized license revenue of$125.0 million during the three and nine months endedSeptember 30, 2020 associated with the TUKYSA Agreement, and we recognize such cost sharing proportionately with the performance of the underlying activities, while recording Merck's reimbursement of our expenses as a reduction of research and development expenses. Sales of TUKYSA drug product supplied is included in collaboration and license agreement revenues. The prepayment received for global development cost-sharing was recorded as a co-development liability in other long-term liabilities on our condensed consolidated balance sheet as ofSeptember 30, 2020 . As joint development expenses are incurred, we recognize the portion of Merck's prepayment as a reduction of our research and development expenses on our condensed consolidated statements of net income (loss). As ofSeptember 20, 2020 ,$84.5 million was recorded as the remaining co-development liability. Other technology collaboration and license agreements We have other active collaboration and license agreements for our technology with a number of biotechnology and pharmaceutical companies entered into prior to 2015. We typically receive upfront cash payments and progress- and sales-dependent milestones for the achievement by our licensees of certain events, and annual maintenance fees and support fees for research and development services and materials provided under the agreements. These amounts are recognized as revenue over the performance obligation period if the license is determined not to be distinct from other goods and services provided, or, if there is no performance obligation, upon transfer of control of the goods or services to the customer. Each of these agreements is beyond the initial performance period, and we have no remaining performance obligations. We may receive license maintenance fees and potential milestones and royalties based on collaborator development and regulatory progress, which are recorded in the period achieved in the case of milestones, and during the period of the related sales for royalties. Cost of sales Cost of sales includes manufacturing and distribution costs of product sold, gross profit share with Astellas pursuant to our collaboration, amortization of technology license costs, royalties owed on certain net product sales, as well as royalties owed to our third-party licensors related toTakeda's sales of ADCETRIS. Three months ended September 30, Nine months ended September 30, (dollars in thousands) 2020 2019 % Change 2020 2019 % Change Cost of sales$ 78,296 $ 10,827 623 %$ 155,962 $ 32,024 387 % Cost of sales increased for the three and nine months endedSeptember 30, 2020 from the comparable periods in 2019, driven by the Astellas gross profit share related to PADCEV net product sales, a payment owed to a third-party technology licensor resulting from the TUKSYA Agreement, amortization expense associated with TUKSYA, and in-licensing royalties owed on PADCEV and TUKYSA net product sales. We and Astellas launched PADCEV in theU.S. inDecember 2019 . The gross profit share with Astellas totaled$29.1 million and$72.6 million for the three and nine months endedSeptember 30, 2020 , respectively. We recorded amortization expense of$5.8 million and$10.5 million for acquired TUKYSA technology costs during the three and nine months endedSeptember 30, 2020 , respectively, which began following FDA approval of TUKYSA inApril 2020 . We expect cost of sales to substantially increase in 2020 as compared to 2019 as a result of the net product sales growth of our commercial-stage drugs, and the payment owed to a third-party technology licensor resulting from the TUKYSA Agreement. This includes cost of product sales for PADCEV and the gross profit share with Astellas under our collaboration. Growth will also be driven by the cost of product sales for TUKYSA and the amortization of acquired technology costs. The increase in cost of sales will also reflect expected growth in ADCETRIS net product sales. Product costs of sales includes a low-single digit royalty on ADCETRIS sales, a mid-single digit royalty on PADCEV sales, and a low double-digit royalty on TUKYSA sales, and royalties on Merck's potential TUKYSA net sales and development milestones related to licensed technology applicable to the drug. Cost of sales for PADCEV and TUKYSA in 2020 will be partially reduced by the use of product inventory that was manufactured prior to FDA approval, and previously charged to research and development expense. Research and development Three months ended September 30, Nine months ended September 30, (dollars in thousands) 2020 2019 % Change 2020 2019 % Change Research and clinical development$ 155,693 $ 136,000 14 %$ 426,079 $ 352,131 21 % Process sciences and manufacturing 61,977 60,119 3 % 184,866 166,182 11 % Total research and development$ 217,670 $ 196,119 11 %$ 610,945 $ 518,313 18 %
Certain prior year balances have been reclassified within research and development expenses to conform to current year presentation.
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Research and clinical development expenses include personnel, occupancy and laboratory expenses, technology access fees, preclinical translational biology and in vitro and in vivo studies, IND-enabling pharmacology and toxicology studies, and external clinical trial costs including costs for clinical sites, clinical research organizations, contractors and regulatory activities associated with conducting human clinical trials. The increase for the three and nine months endedSeptember 30, 2020 from the comparable periods in 2019 primarily reflected increases in employee-related costs and external development costs mainly to support our early- and late-stage pipeline of product candidates. Process sciences and manufacturing expenses include personnel and occupancy expenses, manufacturing costs for the scale-up and pre-approval manufacturing of drug product used in research and our clinical trials, and costs for drug product supplied to our collaborators. Process sciences and manufacturing expenses also include quality control and assurance activities, and storage and shipment of our product candidates. The increase for the three and nine months endedSeptember 30, 2020 from the comparable periods in 2019 primarily reflected increases in employee-related costs and external development costs primarily to support our early- and late-stage pipeline of product candidates. We utilize our employee and infrastructure resources across multiple research and development projects. We track human resource efforts expended on many of our programs for purposes of billing our collaborators for time incurred at agreed upon rates and for resource planning. We do not account for actual costs on a project basis as it relates to our infrastructure, facility, employee and other indirect costs; however, we do separately track significant third-party costs including clinical trial costs, manufacturing costs and other contracted service costs on a project basis. To that end, the following table shows third-party costs incurred for research, contract manufacturing of our product candidates and clinical and regulatory services, as well as milestone payments for in-licensed technology for our products and certain of our clinical-stage product candidates. The table also presents other costs and overhead consisting of third-party costs for our preclinical stage programs, as well as personnel, facilities, manufacturing, and other indirect costs not directly charged to development programs. Three months ended September
30, Nine months ended
2020 2019 2020 2019 September 30, 2020 ADCETRIS (brentuximab vedotin)$ 16,669 $ 11,539
18,799 23,441 56,768 67,269 181,784 PADCEV (enfortumab vedotin-ejfv) 13,639 10,243 27,450 23,437 115,968 Tisotumab vedotin 8,412 9,746 21,513 24,420 80,211 Ladiratuzumab vedotin 4,564 5,260 13,577 15,940 85,040 Other clinical stage programs 7,566 7,739 22,892 21,328 267,746 Total third-party costs for clinical stage programs 69,649 67,968 181,971 185,712 1,021,158 Other costs and overhead 148,021 128,151 428,974 332,601 1,785,079 Total research and development$ 217,670 $ 196,119
Third-party costs for ADCETRIS increased for three and nine months endedSeptember 30, 2020 from the comparable periods in 2019, primarily due to increased activities associated with our ongoing ADCETRIS clinical trials. Third-party costs for TUKYSA decreased for the three and nine months endedSeptember 30, 2020 , as compared to the comparable periods in 2019, primarily due to lower clinical supply expenses. Following the approval of TUKYSA inApril 2020 , we began capitalizing inventory costs manufactured for commercial sale. Third-party costs for PADCEV increased for the three and nine months endedSeptember 30, 2020 from the comparable periods in 2019, primarily due to increased activities associated with our ongoing PADCEV clinical trials. Third-party costs for tisotumab vedotin decreased for the three and nine months endedSeptember 30, 2020 , from the comparable periods in 2019, due to the timing of our and Genmab's ongoing clinical trials. Third-party costs for ladiratuzumab vedotin decreased for the three and nine months endedSeptember 30, 2020 , as compared to the comparable periods in 2019, primarily due to lower research and clinical development expenses. Other costs and overhead include third-party costs of our preclinical programs and costs associated with personnel and facilities. These costs increased for the three and nine months endedSeptember 30, 2020 from the comparable periods in 2019, due to the addition of new preclinical programs and higher employee-related expenses from headcount growth. 30
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In order to advance our product candidates toward commercialization, the product candidates are tested in numerous preclinical safety, toxicology and efficacy studies. We then conduct clinical trials for those product candidates that take several years or more to complete. The length of time varies substantially based upon the type, complexity, novelty and intended use of a product candidate. We will also need to conduct additional clinical trials in order to expand labeled indications of use for our commercial products. The outcome of our clinical trials is uncertain. The cost of clinical trials may vary significantly as a result of a variety of factors, including the number of patients enrolled, patient site costs, quantity and source of drug supply required, safety and efficacy of the product candidate, and extent of regulatory efforts, among others. We anticipate that our total research and development expenses in 2020 will increase compared to 2019, primarily due to higher costs for the continued development of our approved products and product candidates. The risks and uncertainties associated with our research and development projects are discussed more fully in "Part II Item 1A-Risk Factors." As a result of these risk and uncertainties, we are unable to determine with any degree of certainty the duration and completion costs of our research and development projects, anticipated completion dates, or when and to what extent we will receive cash inflows from the commercialization and sale of our products in any additional approved indications or of any of our product candidates.
Selling, general and administrative
Three months ended September 30, Nine months ended September 30, (dollars in thousands) 2020 2019 % Change 2020 2019 % Change Selling, general and administrative$ 127,579 $ 96,101 33 %$ 375,470 $ 258,703 45 % Selling, general and administrative expenses increased for the three and nine months endedSeptember 30, 2020 from the comparable periods in 2019 primarily due to increased field sales personnel for our recently commercialized products, and higher infrastructure costs to support our continued growth. We anticipate that selling, general and administrative expenses will increase in 2020 as compared to 2019 as we support the launches of PADCEV and TUKYSA, and invest in infrastructure to support our continued growth.
Investment and other income (loss), net
Three months ended September 30, Nine months ended September 30, (dollars in thousands) 2020 2019 % Change 2020 2019 % Change Gain (loss) on equity securities $ -$ (5,690) (100) %$ 11,604 $ (10,258)
(213) %
Investment and other income, net 1,223 3,561 (66) % 6,347 7,909 (20) % Total investment and other income (loss), net$ 1,223 $ (2,129) (157) %$ 17,951 $ (2,349) (864) % Investment and other income (loss), net includes other non-operating income and loss, such as unrealized holding gains and losses on equity securities (which primarily included common stock holdings in Immunomedics prior to the sale of these securities inApril 2020 ), realized gains and losses on equity and debt securities, and amounts earned on our investments inU.S. Treasury securities. The gain on equity securities in the nine months endedSeptember 30, 2020 was primarily driven by a realized gain inApril 2020 from the sale of our equity securities, offset in part by an unrealized loss on equity securities during the three months endedMarch 31, 2020 . InApril 2020 , we sold our Immunomedics common stock holdings for$174.7 million , and, accordingly, recognized the associated realized gain in our condensed consolidated statements of comprehensive income (loss) for the nine months endedSeptember 30, 2020 . Investment and other income, net reflects amounts earned on our investments inU.S. Treasury securities. Investment and other income, net decreased for the three and nine months endedSeptember 30, 2020 compared to the comparable periods in 2019, due to lower average yields on our investment portfolio during the 2020 periods. 31
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Provision for income taxes We recorded a provision for income taxes of$3.2 million for the three and nine months endedSeptember 30, 2020 . We utilized deferred tax assets to offset a Federal tax liability, however, we incurred certain state tax liabilities due to the apportionment of income to some states in which there were limitations of the utilization of net operating losses to offset the respective tax liability. Liquidity and capital resources (in thousands) September 30, 2020 December 31, 2019 Cash, cash equivalents, and investments $ 1,718,375 $ 868,338 Working capital 1,572,901 917,284 Stockholders' equity 2,258,030 1,876,287 Nine months ended September 30, (in thousands) 2020 2019 Cash provided (used) by: Operating activities$ 667,424 $ (151,886) Investing activities (95,440) (342,883) Financing activities 72,773 610,049 The change in net cash from operating activities was primarily due to the change in our net income (loss), working capital fluctuations and changes in our non-cash expenses, all of which are highly variable. The change in net cash from investing activities reflected differences between the proceeds received from sale and maturity of our investments, proceeds from sales of securities, and amounts reinvested. The change in net cash from financing activities was driven by differences in proceeds from stock option exercises and our employee stock purchase plan. We primarily have financed our operations through the issuance of our common stock, collections from commercial sales of our products, amounts received pursuant to product collaborations and our ADC collaborations, and royalty revenues. To a lesser degree, we also have financed our operations through investment income. These financing and revenue sources have allowed us to maintain adequate levels of cash and investments. Our cash, cash equivalents, and investments are held in a variety of non-interest bearing bank accounts and interest-bearing instruments subject to investment guidelines allowing for holdings inU.S. government and agency securities, corporate securities, taxable municipal bonds, commercial paper and money market accounts. Our investment portfolio is structured to provide for investment maturities and access to cash to fund our anticipated working capital needs. However, if our liquidity needs should be accelerated for any reason in the near term, or investments do not pay at maturity, we may be required to sell investment securities in our portfolio prior to their scheduled maturities, which may result in a loss. As ofSeptember 30, 2020 , we had$1.7 billion held in cash, cash equivalents and investments scheduled to mature within the next twelve months. At our currently planned spending rates, we believe that our existing financial resources together with product sales, royalty revenues, and the milestone payments and reimbursements we expect to receive under our existing collaboration and license agreements, will be sufficient to fund our operations for at least the next twelve months. We expect to make additional capital outlays and to increase operating expenditures over the next several years as we hire additional employees, and support our development, commercialization, and planned global expansion, which may require us to raise additional capital. Further, we actively evaluate various strategic transactions on an ongoing basis, including licensing or otherwise acquiring complementary products, technologies or businesses, and we may require significant additional capital in order to complete or otherwise provide funding for such transactions. We may seek additional capital through some or all of the following methods: corporate collaborations, licensing arrangements, and public or private debt or equity financings. In this regard, our ability to raise additional funds may be adversely impacted by deteriorating global economic conditions and the disruptions to and volatility in the credit and financial markets inthe United States and worldwide resulting from the evolving effects of the COVID-19 pandemic. We do not know whether additional capital will be available when needed, or that, if available, we will obtain financing on terms favorable to us or our stockholders. If we are unable to raise additional funds when we need them, our business and operations may be adversely affected. Commitments Our future minimum contractual commitments were reported in our Annual Report on Form 10-K for the year endedDecember 31, 2019 . Our future minimum contractual commitments have not changed materially from the amounts previously reported. 32
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Critical accounting policies The preparation of financial statements in accordance with generally accepted accounting principles requires us to make estimates, assumptions, and judgments that affect the amounts reported in the financial statements and accompanying notes. We evaluate our estimates on an ongoing basis. We base our estimates on historical experience and other assumptions that we believe to be reasonable under the circumstances. Actual results may differ from those estimates. Our critical accounting policies, those with the more significant judgments and estimates, used in the preparation of our financial statements for the nine months endedSeptember 30, 2020 were consistent with those in Part II Item 7 of our Annual Report on Form 10-K for the year endedDecember 31, 2019 , except for the following updates: Revenue recognition Net product sales: We sell ADCETRIS, PADCEV, and TUKYSA through a limited number of specialty distributors and specialty pharmacies. We and our collaboration partner Astellas Pharma, Inc. or Astellas jointly promote PADCEV in theU.S. Under the joint promotion in theU.S. , we record net sales of PADCEV and are responsible for all distribution through a limited number of specialty distributors. The delivery of our products represents a single performance obligation for these transactions and we record net product sales at the point in time when title and risk of loss pass. The transaction price for net product sales represents the amount we expect to receive, which is net of estimated government-mandated rebates and chargebacks, distribution fees, estimated product returns and other deductions. Accruals are established for these deductions, and actual amounts incurred are offset against applicable accruals. We reflect these accruals as either a reduction in the related account receivable from the distributor or as an accrued liability, depending on the nature of the sales deduction. Sales deductions are based on management's estimates that consider payor mix in target markets and experience to-date. These estimates involve a substantial degree of judgment. We have applied a portfolio approach as a practical expedient for estimating net product sales. Government-mandated rebates and chargebacks: We have entered into a Medicaid Drug Rebate Agreement, or MDRA, with theCenters for Medicare & Medicaid Services . This agreement provides for a rebate based on covered purchases of our products. Medicaid rebates are invoiced to us by the various state Medicaid programs. We estimate Medicaid rebates using the expected value approach, based on a variety of factors, including payor mix and our experience to-date. We have a Federal Supply Schedule, or FSS, agreement under which certainU.S. government purchasers receive a discount on eligible purchases of our products. In addition, we have entered into a Pharmaceutical Pricing Agreement with the Secretary ofHealth and Human Services , which enables certain entities that qualify for government pricing under the Public Health Services Act, or PHS, to receive discounts on their qualified purchases of our products. Under these agreements, distributors process a chargeback to us for the difference between wholesale acquisition cost and the applicable discounted price. We estimate expected chargebacks for FSS and PHS purchases based on the expected value of each entity's eligibility for the FSS and PHS programs. We also review historical rebate and chargeback information to further refine these estimates. Distribution fees, product returns and other deductions: Our distributors charge a volume-based fee for distribution services that they perform for us. We allow for the return of product that is within a specified number of days prior to or past expiration date or that is damaged. We estimate product returns based on our experience to-date using the expected value approach. We provide financial assistance to qualifying patients that are underinsured or cannot cover the cost of commercial coinsurance through our patient support programs. Estimated contributions for commercial coinsurance under Seagen Secure are deducted from gross sales and are based on an analysis of expected plan utilization. These estimates are adjusted as necessary to reflect our actual experience. Business combinations, including acquired in-process research and development and goodwill. We account for business combinations using the acquisition method, recording the acquisition-date fair value of total consideration over the acquisition-date fair value of net assets acquired as goodwill. Fair value is typically estimated using an income approach based on the present value of future discounted cash flows. The significant estimates in the discounted cash flow model primarily include the discount rate, and rates of future revenue and expense growth and/or profitability of the acquired business. The discount rate considers the relevant risk associated with business-specific characteristics and the uncertainty related to the ability to achieve the projected cash flows. We may record adjustments to the fair values of assets acquired and liabilities assumed within the measurement period (up to one year from the acquisition date). In-process research and development assets are accounted for as indefinite-lived intangible assets and maintained on the balance sheet until either the underlying project is completed or the asset becomes impaired. If the project is completed, which generally occurs when FDA approval is obtained, the carrying value of the related intangible asset is amortized to cost of sales on a straight-line basis over the estimated useful life of the asset beginning in the period in which the project is completed. We periodically evaluate when facts or circumstances indicate that the carrying value of these assets may not be recoverable. If the asset becomes impaired or is abandoned, the carrying value of the related intangible asset is written down to its fair value and an impairment charge is recorded in the period in which the impairment occurs. 33
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Tabl e o f C o n t e n t s
We evaluate indefinite-lived intangible assets and goodwill for impairment annually, as ofOctober 1 , or more frequently when events or circumstances indicate that impairment may have occurred. As part of the impairment evaluation, we may elect to perform an assessment of qualitative factors. If this qualitative assessment indicates that it is more likely than not that the fair value of the indefinite-lived intangible asset or the reporting unit (for goodwill) is less than its carrying value, we then would proceed with the quantitative impairment test to compare the fair value to the carrying value and record an impairment charge if the carrying value exceeds the fair value. Acquisition-related costs, including banking, legal, accounting, valuation, and other similar costs, are expensed in the period in which the costs are incurred. The results of operations of the acquired business are included in the consolidated financial statements from the acquisition date. Recent accounting pronouncements Refer to "Part I Item 1 Note 1--Summary of significant accounting policies" for a discussion on recent accounting pronouncements.
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