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 targeted therapies to treat 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 the 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. Second quarter 2021 highlights and recent developments Corporate •Achieved 44% growth in net product sales for the quarter endedJune 30, 2021 compared to the quarter endedJune 30, 2020 . Generated record quarterly net product sales across all commercial brands. •Continued to make strategic investments in our pipeline, commercial launches, infrastructure, and headcount to support our future growth.
ADCETRIS
•Published the five-year update of the phase 3 ECHELON-1 clinical trial in frontline advanced Hodgkin lymphoma in the Lancet Haematology.
PADCEV
•U.S.Food and Drug Administration , or FDA: •converted PADCEV's accelerated approval to regular approval; and •approved a new indication for PADCEV in the treatment of patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy. •Published results from the second cohort of the EV-201 trial for patients with locally advanced or metastatic urothelial cancer that received prior treatment with an immunotherapy but had not received a platinum-containing chemotherapy and were ineligible for cisplatin chemotherapy in The Lancet Oncology.
TUKYSA
•Presented long-term results for HER2CLIMB trial at the 2021American Society of Clinical Oncology , or ASCO, annual meeting demonstrating median survival for the TUKYSA arm extended to two years with benefit maintained across all prespecified patient subgroups. 15
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Pipeline
•Biologics License Application, or BLA, accepted for Priority Review of tisotumab vedotin for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. FDA set a Prescription Drug User Fee Act, or PDUFA, target action date ofOctober 10, 2021 . •Published the results of the innovaTV 204 pivotal phase 2 trial inThe Lancet Oncology inApril 2021 . Our Medicines Our approved medicines include the following: Product* Therapeutic Area U.S. Approved Indication
Previously untreated Stage III/IV classical Hodgkin
lymphoma, or cHL, in combination with doxorubicin,
vinblastine and dacarbazine
cHL at high risk of relapse or progression as
Hodgkin Lymphoma
post-autologous hematopoietic stem cell transplantation,
or auto-HSCT, consolidation
cHL after failure of auto-HSCT or after failure of at
least two prior multi-agent chemotherapy regimens in
patients who are not auto-HSCT candidates
[[Image Removed: sgen-20210630_g1.jpg]]
Previously untreated systemic anaplastic large cell
lymphoma, or sALCL, or other CD30-expressing peripheral
T-cell lymphoma, or PTCL, including angioimmunoblastic
T-cell lymphoma and PTCL not otherwise specified, in
combination with cyclophosphamide, doxorubicin and
T-cell Lymphoma
prednisone
sALCL after failure of at least one prior multi-agent
chemotherapy regimen
Primary cutaneous anaplastic large cell lymphoma, or
pcALCL, or CD30-expressing mycosis fungoides who have
received prior systemic therapy
Locally advanced or metastatic urothelial cancer for
patients who:
•have previously received a programmed death receptor-1
[[Image Removed: sgen-20210630_g2.jpg]] Urothelial Cancer (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and
platinum-containing chemotherapy, or
•are ineligible for cisplatin-containing chemotherapy and
have previously received one or more prior lines of
therapy.
In combination with trastuzumab and capecitabine for the
treatment of adult patients with advanced unresectable or
[[Image Removed: sgen-20210630_g3.jpg]] Breast Cancer
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.
•*ADCETRIS, PADCEV and TUKYSA are only indicated for use in adults. u
ADCETRIS®
ADCETRIS is an ADC targeting CD30, which is a protein located on the surface of cells and highly expressed in Hodgkin lymphoma, certain T-cell lymphomas as well as other cancers. ADCETRIS first received FDA approval in 2011 and is now approved in a total of six indications to treat Hodgkin lymphoma and certain T-cell lymphomas in various settings including as frontline therapy. ADCETRIS is commercially available in more than 75 countries worldwide. We commercialize ADCETRIS in theU.S. and its territories and inCanada , and we collaborate with Takeda Pharmaceutical Company Limited, or Takeda, 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. Takeda has received regulatory approvals for ADCETRIS as monotherapy or in combination with other agents in various settings for the treatment of patients with Hodgkin lymphoma or CD30-positive T-cell lymphomas inEurope and many countries throughout the rest of the world and is pursuing additional regulatory approvals. 16
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PADCEV®
PADCEV is an ADC targeting Nectin-4, a protein expressed on the surface of cells and highly expressed in bladder cancer as well as other cancers. 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 in the locally advanced or metastatic setting. FDA approval of PADCEV was supported by data from a single-arm pivotal phase 2 clinical trial called EV-201. InJuly 2021 , the FDA converted PADCEV's accelerated approval to regular approval in theU.S. , in addition to granting regular approval for a new indication for adult patients with locally advanced or metastatic urothelial cancer, who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy. The conversion to regular approval was supported by the pivotal phase 3 trial called EV-301 and the expanded indication was supported by data from the second cohort in the EV-201 trial. The FDA reviewed the application for regular approval under theOncology Center of Excellence's , or OCE's, Real Time Oncology Review, or RTOR, pilot program. 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. TUKYSA® 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. HER2 mediates cell growth, differentiation and survival. Tumors that over-express HER2 are generally more aggressive and historically have been associated with poor overall survival, compared with HER2-negative cancers. 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. FDA approval of TUKYSA was supported by data from the HER2CLIMB trial. The application for approval was reviewed under theFDA's RTOR pilot program. We also participated 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 in theU.S. ,Canada ,Australia ,Singapore , andSwitzerland . InFebruary 2021 , the EC granted marketing authorization for TUKYSA in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least two prior anti-HER2 treatment regimens. This approval is valid in all countries of theEuropean Union as well asNorway ,Liechtenstein ,Iceland andNorthern Ireland . InMarch 2021 , we began marketing TUKYSA inAustria ,France andGermany . Additionally, inFebruary 2021 , theUK Medicines and Healthcare products Regulatory Agency, or MHRA, granted aGreat Britain marketing authorization for TUKYSA. We are responsible for commercializing TUKYSA in theU.S. ,Canada andEurope . InSeptember 2020 , we entered into a license and collaboration agreement, or the TUKYSA Agreement, with a subsidiary of Merck & Co., Inc., or Merck, pursuant to which we 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. Clinical Development and Regulatory Status ADCETRIS (brentuximab vedotin) Beyond our current labeled indications, we are evaluating ADCETRIS as monotherapy and in combination with other agents in ongoing trials, including several potential registration-enabling trials such as the ECHELON-3 phase 3 trial in relapsed or refractory diffuse large B-cell lymphoma. In addition to our corporate-sponsored trials there are numerous investigator-sponsored trials of ADCETRIS inthe United States . The investigator-sponsored trials include the use of ADCETRIS in a number of malignant hematologic indications and in solid tumors. 17
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PADCEV (enfortumab vedotin-ejfv) In collaboration with Astellas we are conducting or planning to conduct clinical trials across the spectrum of bladder cancer including ongoing trials in frontline metastatic urothelial cancer and muscle invasive bladder cancer. We are planning to conduct a trial in non-muscle invasive bladder cancer. In addition, we are conducting a trial in a range of other solid tumors. InSeptember 2020 , we announced that the EV-301 trial, 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, compared to chemotherapy. For patients in the PADCEV arm of the trial, rash, fatigue, and decreased neutrophil count were the most frequent Grade 3 or greater treatment-related adverse events occurring in more than 5 percent of patients. InJuly 2021 , the FDA converted PADCEV's accelerated approval to regular approval based on data from the EV-301 trial. InMarch 2021 , theEuropean Medicines Agency , or EMA, accepted for review a Marketing Authorization Application, or MAA, for PADCEV based on the EV-301 trial. In addition, applications have been submitted for PADCEV approval inAustralia andCanada , under theFDA's Project Orbis program, as well as inJapan ,Singapore ,Brazil andSwitzerland . 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. InMay 2021 the primary results of the cohort were published in the Lancet Oncology. InMay 2021 , we reported updated analysis of the second cohort at the 2021 ASCO annual meeting. With a median follow-up of 16 months, 51 percent of patients who received PADCEV had a confirmed objective response [95% Confidence Interval, or CI: 39.8, 61.3] per blinded independent central review (the primary endpoint), with 22 percent of patients experiencing a complete response, or CR. Median duration of response, or DOR, was 13.8 months [95% CI: 6.4, not reached]. Patients lived a median of 6.7 months without cancer progression [progression-free survival, or PFS (95% CI: 5.0-8.3)] and had a median OS of 16.1 months (95% CI: 11.3, 24.1). The most common all-grade treatment-related adverse events, or TRAEs, were alopecia (51%), peripheral sensory neuropathy (49%) and fatigue (34%), and the most common Grade 3 or greater TRAEs were neutropenia (9%), maculopapular rash (8%) and fatigue (7%). Grade 3 or greater TRAEs of special interest included skin reactions (17%), peripheral neuropathy (8%) and hyperglycemia (6%). Four deaths were previously reported as treatment-related by investigators in patients age 75 years and older with multiple comorbidities. InJuly 2021 , the FDA granted regular approval for a new indication for adult patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy. The approval was based on data from the second cohort of the EV-201 trial. PADCEV is also being investigated in first-line 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. 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 , based on the positive initial results of the dose-escalation cohort and the expansion Cohort A 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. We expect to complete enrollment in cohort K by the end of 2021. InMay 2021 , we presented updated results of the dose-escalation cohort and the expansion Cohort A of the EV-103 trial at the 2021 ASCO annual meeting. As previously reported, results demonstrated an objective response rate of 73.3 percent (95% CI: 58.1, 85.4) per investigator assessment, with 15.6 percent of patients experiencing a CR. The median PFS was 12.3 months (95% CI: 8.0, not reached). The updated data after a median follow-up of two years showed a median DOR of 25.6 months (95% CI: 8.3, not reached) and median OS of 26.1 months (95% CI: 15.7, not reached). The longer-term analysis demonstrated a safety profile generally consistent with previous findings. The most common TRAEs were peripheral sensory neuropathy (55.6%), fatigue (51.1%) and alopecia (48.9%), and the most common Grade 3 or greater TRAEs were increased lipase (17.8%), maculopapular rash (11.1%) and fatigue (11.1%). Grade 3 or greater TRAEs of interest included skin reactions (20%), hyperglycemia (8.9%) and peripheral neuropathy (4.4%). There was one death previously reported as possibly related to study treatment (multiple organ dysfunction syndrome). 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 18
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subsidiary of 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. The trial has dual primary endpoints of PFS and OS and is intended to support global regulatory submissions 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, called KEYNOTE-B15/EV-304, to be conducted by Merck in cisplatin-eligible patients with MIBC. This trial was initiated in the first quarter of 2021. 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. TUKYSA (tucatinib) 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. The positive results of the HER2CLIMB trial served as the basis for approval in theU.S. ,Canada , theEuropean Union as well as other countries. Merck is co-funding a portion of the TUKYSA global development plan. 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 supporting aU.S. cooperative group, theAlliance for Clinical Trials in Oncology, that is conducting a phase 3 randomized trial, called CompassHER2 RD, which is evaluating TUKYSA in combination with T-DM1 in the adjuvant setting for patients with high-risk, HER2-positive breast cancer. We are also conducting a phase 2 trial, called HER2CLIMB-04, evaluating TUKYSA in combination with trastuzumab deruxtecan in previously treated locally-advanced or metastatic HER2-positive breast cancer. We are 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 expect to complete enrollment by the end of 2021. 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. 19
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Tisotumab Vedotin In collaboration with Genmab we are developing tisotumab vedotin for metastatic cervical cancer and are evaluating it for other solid tumors. We and Genmab are conducting a pivotal phase 2 trial, called innovaTV 204, evaluating single-agent tisotumab vedotin for patients with recurrent 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 and inApril 2021 were published in The Lancet Oncology. Results from the trial showed a 24 percent confirmed objective response rate, or ORR, by independent central review with a median DOR of 8.3 months. The most common treatment-related adverse events (greater than or equal to 20 percent) included alopecia, epistaxis (nose bleeds), nausea, conjunctivitis, fatigue and dry eye. InApril 2021 , the FDA accepted for Priority Review the BLA seeking accelerated approval for tisotumab vedotin. This BLA requests FDA approval of tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. The FDA has set a PDUFA target action date ofOctober 10, 2021 . InJanuary 2021 , we and Genmab initiated a phase 3 clinical trial, called innovaTV 301, to evaluate tisotumab vedotin compared to chemotherapy in patients with recurrent or metastatic cervical cancer who have received one or two prior lines of therapy. innovaTV 301 is intended to support global regulatory applications for potential approvals in regions where innovaTV 204 does not support approval and to potentially serve as a confirmatory trial in theU.S. if we are able to obtain accelerated approval based on the innovaTV 204 trial. 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- and second-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 We are developing 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 . Other clinical and early-stage product candidates We are advancing a pipeline of early-stage clinical candidates as well as multiple preclinical and research-stage programs that employ our proprietary technologies. We advanced several product candidates into clinical development in 2020 and we plan to submit additional investigational new drug applications, or INDs, to the FDA in 2021. 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 ; andGlaxoSmithKline LLC , or GSK, as well as collaboration agreements with Astellas and Genmab.Genentech and GSK have received approval for ADC drugs that utilize our technology, Polivy® (polatuzumab vedotin-piic) and Blenrep™ (belantamab mafodotin-blmf), respectively, in theU.S. ,European Union and other countries. Under our ADC license agreements withGenentech and GSK, we are entitled to receive royalties on net sales of Polivy and Blenrep worldwide. 20
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COVID-19
We are continuing to closely monitor the impact of the evolving effects of the COVID-19 pandemic on our business. We are continuing to take proactive steps designed to protect the health and safety of our workforce, patients and healthcare professionals, to continue our business operations and to advance our goal of bringing important medicines to patients as rapidly as possible. Earlier in the pandemic, we instituted a mandatory work-from-home policy for employees who could perform their jobs offsite, and we have continued our essential research, manufacturing, and laboratory activities on site. Recently, we began to allow additionalU.S. office-based employees who have been fully vaccinated to return to the office on a voluntary and limited basis. We maintain a number of precautionary measures designed to protect our on-site employees, such as enhanced facilities cleaning, lower concentrations of staff, contact tracing and making testing available. In addition, in accordance with guidelines from government authorities, we have additional precautionary measures for facilities with essential research, manufacturing and laboratory staff, who may not all be fully vaccinated, including temperature checks, screening protocols, masks and social distancing. After pausing most in-person customer interactions in healthcare settings earlier in the pandemic, our field-based personnel are now engaging in an increasing number of 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. They are also using electronic communications to continue to support healthcare professionals and patients when they cannot meet with healthcare providers face-to-face. 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 We recognize revenue from ADCETRIS product sales in theU.S. andCanada . While we anticipate that sales of ADCETRIS will increase modestly in 2021 as compared to 2020, we have experienced and expect continued impacts associated with the COVID-19 pandemic, which appear to have led to a reduction in the rate of Hodgkin lymphoma diagnoses and may further adversely affect the rate of Hodgkin lymphoma diagnoses in the future. We have also experienced 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. We may also experience additional shifts from commercial payor coverage to government payor coverage in theU.S. , which would further increase gross-to-net deductions. We also expect that our ability to maintain or continue to grow our ADCETRIS sales, if at all, will depend 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 upheld, or adopted in the future, including measures that could result in more rigorous coverage criteria or reduce 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, continuing impacts resulting from the evolving effects of the COVID-19 pandemic including potential further impacts from 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. We recognize revenue from PADCEV product sales in theU.S. 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 indications, 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. , 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 indications, 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, as a result of these and other factors, including the lack of significant historical sales data, PADCEV sales are currently difficult to predict from period to period. 21
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We recognize revenue from TUKYSA product sales in theU.S. ,Europe , andCanada . 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, 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 adequate levels of reimbursement will be 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 TUKYSA, our ability 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, as a result of these and other factors, including the lack of significant historical sales data, 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 health care costs to continue to be subject to intense political and societal pressures on a global basis. For example, inJuly 2021 , the Biden administration announced an Executive Order that includes initiatives aimed at lowering prescription drug costs and implementing Canadian drug importation. 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 received from our collaboration agreements, including royalties, will continue to be an important source of our revenues and cash flows. These revenues and cash flows 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, 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 the continued development of our commercial infrastructure inEurope and our plans 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. 22
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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. Our field-based personnel are using a mix of in-person interactions and electronic communications, such as emails, phone calls and video conferences, to support healthcare providers and patients. 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 continuing to experience increased competition for virtual appointments with healthcare professionals and 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. In this regard, we believe that the need to conduct some of our 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 due to coronavirus mutations and/or low vaccination rates or otherwise, the need to navigate varying restrictions for entering healthcare facilities and the pandemic's impacts on employee childcare arrangements. 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 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 appear to have negatively affected and may continue to 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, some or all of which appear to have negatively affected diagnosis rates, may affect side effect management and course of treatment and may increase enrollment in our patient support programs. With respect to ADCETRIS specifically, impacts associated with the COVID-19 pandemic appear to have led to a reduction in the rate of Hodgkin lymphoma diagnoses and may further adversely affect the rate of Hodgkin lymphoma diagnoses in the future. In addition, we have experienced 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 formats. 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 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, including the effectiveness and timing of vaccine programs in theU.S. and worldwide. 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. Financial summary For the six months endedJune 30, 2021 , our total revenues increased to$720.5 million , compared to$512.5 million for the same period in 2020. This growth was primarily driven by theU.S. launch of TUKYSA inApril 2020 and higher PADCEV net product sales. 23
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For the six months endedJune 30, 2021 , total costs and expenses increased to$932.5 million , compared to$718.8 million for the same period in 2020. This reflected higher selling, general and administrative expenses, research and development expenses, and cost of sales. As ofJune 30, 2021 , we had$2.5 billion in cash, cash equivalents and investments and$3.4 billion in total stockholders' equity. Results of operations Net product sales Three months ended June 30, Six months ended June 30, (dollars in thousands) 2021 2020 % Change 2021 2020 % Change ADCETRIS$ 181,912 $ 167,535 9 %$ 344,484 $ 331,588 4 % PADCEV 82,405 57,175 44 % 152,163 91,636 66 % TUKYSA 83,021 15,755 427 % 153,279 15,755 873 %
Net product sales$ 347,338 $ 240,465 44 %$ 649,926 $ 438,979 48 % Our net product sales grew 44% and 48% during the three and six months endedJune 30, 2021 , as compared to the comparable periods in 2020, primarily driven by increased sales volumes following the launch of TUKYSA inApril 2020 and higher PADCEV net product sales. PADCEV net product sales grew primarily due to higher volumes, driven by increased utilization in its initial approved indication for the 2021 periods, following theU.S. launch inDecember 2019 . ADCETRIS net product sales increased during the three and six months endedJune 30, 2021 , as compared to the comparable periods in 2020, primarily due to higher volumes of vials sold. We expect growth in net product sales in 2021 from 2020 to be primarily driven by sales growth of TUKYSA and PADCEV, and to a lesser extent, ADCETRIS. 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, 2020$ 44,193 $ 15,689$ 59,882 Provision related to current period sales 236,039 20,232 256,271 Adjustment for prior period sales (2,687) (613) (3,300) Payments/credits for current period sales (197,286) (13,961) (211,247) Payments/credits for prior period sales (26,949) (6,073) (33,022) Balance as of June 30, 2021$ 53,310 $ 15,274$ 68,584 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 six months endedJune 30, 2021 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 ofJune 30, 2021 and 2020 was for ADCETRIS 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 2021 as compared to 2020, driven by anticipated growth in our gross product sales. Royalty revenues Royalty revenues primarily reflect royalties earned under the ADCETRIS collaboration with Takeda. These royalties include commercial sales-based milestones and sales royalties. Sales royalties are based on a percentage of Takeda'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, and amounts from GlaxoSmithKline earned on net sales of Blenrep beginning in 2020, both of which utilizes technology that we have licensed to them. 24
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Table of Contents Three months ended June 30, Six months ended June 30, (dollars in thousands) 2021 2020 % Change 2021 2020 % Change Royalty revenues$ 36,296 $ 31,235 16 %$ 63,514 $ 51,595 23 % Royalty revenues increased for the three and six months endedJune 30, 2021 from the comparable periods in 2020, primarily due to growth in Takeda net sales of ADCETRIS in its territories, as well as higher royalties earned on net sales of Blenrep and Polivy by our other licensees. We expect that royalty revenues will increase in 2021 as compared to 2020 primarily due to higher royalties from anticipated growth in ADCETRIS sales volume by Takeda, as well as anticipated growth of our other licensees' net product sales. Collaboration and license agreement revenues Collaboration and license agreement revenues reflect amounts earned under certain of our license and collaboration agreements. These revenues reflect license fees, payments received by us for technology access and maintenance fees, sales of drug supply to our collaborators, 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 June 30, Six months ended June 30, (dollars in thousands) 2021 2020 % Change 2021 2020 % Change Takeda $ -$ 5,598 (100) % 1,851 15,913 (88) % Other 4,844 700 592 % 5,169 6,025 (14) % Total collaboration and license agreement revenues$ 4,844 $ 6,298 (23) %$ 7,020 $ 21,938 (68) % Collaboration revenues from Takeda for the three and six months endedJune 30, 2021 declined primarily due to a decrease in ADCETRIS drug supply sold to Takeda. Other collaboration revenues increased for the three months endedJune 30, 2021 as compared to the comparable period in 2020 primarily due to drug supply sold to a collaborator in the 2021 period. Other collaboration revenues were relatively consistent for the three months endedJune 30, 2021 , as compared to the comparable period. We expect our collaboration and license agreement revenues in 2021 to significantly decrease compared to 2020, driven by the amounts recognized related to the agreements with Merck in the third and fourth quarters of 2020. 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, amount of drug supplied to our collaborators, the level of support we provide to our collaborators, specifically to Takeda under our ADCETRIS collaboration, 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 with Takeda for the global co-development of ADCETRIS and the commercialization of ADCETRIS by Takeda in its territory. We recognize payments from Takeda, 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 to Takeda, that payment reduces collaboration and license agreement revenues. We also recognize royalty revenues based on a percentage of Takeda'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. 25
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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. Under this collaboration, we and Astellas are equally co-funding all development and certain commercialization costs for 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. Gross profit share payments owed to Astellas in theU.S. under the joint commercialization agreement are recorded in cost of sales. 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 . 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. 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. Under this collaboration, we and Genmab are co-funding all development costs for tisotumab vedotin. In 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. InFebruary 2021 , a BLA for tisotumab vedotin was submitted to the FDA seeking accelerated approval for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, and inApril 2021 , FDA accepted the BLA for Priority Review, and set target action date ofOctober 10, 2021 . •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. Merck LV collaboration InSeptember 2020 , we entered into the LV Agreement with a subsidiary of Merck. We are pursuing a broad joint development program evaluatingLV as monotherapy and in combination setting, including 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 theLV 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$1.8 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 inOctober 2020 . We recognized license revenue of$850.1 million during 2020 associated with the LV Agreement and Purchase 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. 26
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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. We recognized license revenue of$125.0 million during 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 accrued liabilities and other or other long-term liabilities on our condensed consolidated balance sheet as ofJune 30, 2021 . 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 comprehensive loss. As ofJune 30, 2021 andDecember 30, 2020 ,$70.3 million and$80.9 million was recorded as the remaining co-development liability, respectively. Other technology collaboration and license agreements We have other collaboration and license agreements for our ADC technology with a number of biotechnology and pharmaceutical companies. We typically receive upfront cash payments and progress- and sales-dependent milestones for the achievement by our licensees of certain events, and annual maintenance fees and support fees for research and development services and materials provided under the agreements. These amounts are recognized as revenue over the performance obligation period if the license is determined not to be distinct from other goods and services provided, or, if there is no performance obligation, upon transfer of control of the goods or services to the customer. Cost of sales Cost of sales includes manufacturing and distribution costs of product sold, gross profit share with Astellas pursuant to our PADCEV collaboration, amortization of acquired technology license costs, royalties owed on our PADCEV net product sales and global ADCETRIS and TUKYSA net product sales. Three months ended June 30, Six months ended June 30, (dollars in thousands) 2021 2020 % Change 2021 2020 % Change Cost of sales$ 78,090 $ 48,244 62 %$ 142,225 $ 77,665 83 % Cost of sales increased for the three and six months endedJune 30, 2021 from the comparable periods in 2020, driven by the Astellas gross profit share related to PADCEV net product sales, amortization expense associated with acquired TUKYSA technology costs, and in-licensing royalties owed on PADCEV and TUKYSA net product sales. The gross profit share with Astellas totaled$38.6 million and$71.1 million for the three and six months endedJune 30, 2021 , respectively, as compared to$27.1 million and$43.5 million for the comparable periods in 2020. We recorded amortization expense of$11.5 million for acquired TUKYSA technology costs during the six months endedJune 30, 2021 , as compared to$4.7 million during the six months endedJune 30, 2020 . We expect cost of sales to increase in 2021 as compared to 2020 as a result of the net product sales growth of our marketed products, contributing to higher anticipated manufacturing and distribution costs for goods sold and increased royalties owed on certain net sales of our products. This growth also includes higher anticipated gross profit share with Astellas under our PADCEV collaboration, and the full-year 2021 amortization of acquired TUKYSA technology costs. 27
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Table of Contents Research and development Three months ended June 30, Six months ended June 30, (dollars in thousands) 2021 2020 % Change 2021 2020 % Change Research and clinical development$ 164,869 $ 137,158 20 %$ 338,873 $ 270,387 25 % Process sciences and manufacturing 69,992 60,919 15 % 126,413 122,889 3 % Total research and development$ 234,861 $ 198,077 19 %$ 465,286 $ 393,276 18 % 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 six months endedJune 30, 2021 from the comparable periods in 2020 primarily reflected higher 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 product candidates 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 six months endedJune 30, 2021 from the comparable period in 2020 primarily reflected the timing of our manufacturing of product candidates for use in clinical trials, as well as increased manufacturing of our approved products. 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 development 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, personnel, facilities, manufacturing, and other indirect costs not directly charged to development programs, as well as cost reimbursements received from or payments made to collaborators related to our product candidates. Three months ended June 30, Six months ended June 30, (dollars in thousands) 2021 2020 2021 2020 ADCETRIS (brentuximab vedotin)$ 10,990 $
11,396
28,781 15,444 56,903 37,970 PADCEV (enfortumab vedotin-ejfv) 15,966 5,877 26,952 14,006 Tisotumab vedotin 9,384 3,868 21,388 7,443 Ladiratuzumab vedotin 6,955 4,592 11,800 8,960 Other clinical stage programs 11,567 16,197 32,163 22,743 Total third-party costs for clinical stage programs 83,643 57,374 172,075 114,084 Other costs, overhead, and net cost-sharing with collaborators 151,218 140,703 293,211 279,192 Total research and development$ 234,861 $
198,077
Third-party costs for ADCETRIS were consistent for three and six months endedJune 30, 2021 as compared to the 2020 periods. Third-party costs for TUKYSA, PADCEV, tisotumab vedotin, and ladiratuzumab vedotin increased for the three and six months endedJune 30, 2021 as compared to the 2020 periods, due to higher clinical trial costs. Third-party costs for other clinical stage programs decreased for the three months endedJune 30, 2021 , as compared to the 2020 period, due to lower manufacturing costs, and increased for the six months endedJune 30, 2021 as compared to the 2020 period, primarily due to an in-license development milestone payment made in the first quarter of 2021 related to one of our clinical pipeline programs. 28
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Other costs, overhead, and net cost-sharing with collaborators include third-party costs of our preclinical programs and costs associated with personnel and facilities. In total, these net costs were relatively consistent for the three and six months endedJune 30, 2021 from the comparable periods in 2020. During the three months endedJune 30, 2021 and 2020, net cost-sharing reimbursements from and payments made to collaborators were$19.0 million and$0.8 million , respectively. During the six months endedJune 30, 2021 and 2020, net cost-sharing reimbursements from and payments made to collaborators were$40.3 million and$5.7 million , respectively. In order to advance our product candidates toward commercialization, the product candidates are tested in numerous preclinical safety, toxicology and efficacy studies. We then conduct clinical trials for those product candidates that take several years or more to complete. The length of time varies substantially based upon the type, complexity, novelty and intended use of a product candidate. We will also need to conduct additional clinical trials in order to expand labeled indications of use for our commercial products. The outcome of our clinical trials is uncertain. The cost of clinical trials may vary significantly as a result of a variety of factors, including the number of patients enrolled, patient site costs, quantity and source of drug supply required, safety and efficacy of the product candidate, and extent of regulatory efforts, among others. We anticipate that our total research and development expenses in 2021 will increase compared to 2020, primarily due to higher costs for the continued development of our approved products and product candidates. The risks and uncertainties associated with our research and development projects are discussed more fully in "Part II Item 1A-Risk Factors." As a result of these risks and uncertainties, we are unable to determine with any degree of certainty the duration and completion costs of our research and development projects, anticipated completion dates, or when and to what extent we will receive cash inflows from the commercialization and sale of our products in any additional approved indications or of any of our product candidates.
Selling, general and administrative
Three months ended June 30, Six months ended June 30, (dollars in thousands) 2021 2020 % Change 2021 2020 % Change Selling, general and administrative$ 165,130 $ 125,642 31 %$ 324,972 $ 247,891 31 % Selling, general and administrative expenses increased for the three and six months endedJune 30, 2021 from the comparable periods in 2020, reflecting investments to support European TUKYSA launches and our continued growth in theU.S. andEurope . We anticipate that selling, general and administrative expenses will increase in 2021 as compared to 2020 as we continue our commercial activities in support of product launches, and invest in infrastructure to support our continued growth in theU.S. andEurope .
Investment and other income, net
Three months ended June 30, Six months ended June 30, (dollars in thousands) 2021 2020 % Change 2021 2020 % Change Gain on equity securities$ 4,670 $ 70,683 (93) %$ 4,929 $ 11,604 (58) % Investment and other income, net 357 2,092 (83) % 1,098 5,124 (79) % Total investment and other income, net$ 5,027 $ 72,775 (93) %$ 6,027 $ 16,728 (64) % Investment and other income, net includes other non-operating income and loss, such as unrealized holding gains and losses on equity securities, realized gains and losses on equity and debt securities, and amounts earned on our investments inU.S. Treasury securities. Investment income decreased for the three months endedJune 30, 2021 as compared to the comparable period in 2020 primarily driven by a$70.7 million gain from the sale of certain equity securities inApril 2020 . The decrease for the six months endedJune 30, 2021 as compared to the comparable period in 2020 was also impacted by a$59.1 million decline in the fair value of our equity securities during the first quarter of 2020. Our investment portfolio experienced lower average yields during the three and six months endedJune 30, 2021 as compared to the 2020 periods. 29
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Liquidity and capital resources (in thousands) June 30, 2021 December 31, 2020 Cash, cash equivalents, and investments$ 2,451,612 $ 2,660,250 Working capital 2,664,678 2,674,246 Stockholders' equity 3,391,274 3,488,100 Six months ended June 30, (in thousands) 2021 2020 Cash provided (used) by: Operating activities$ (197,770) $ (155,343) Investing activities 20,130 (55,113) Financing activities 32,992 53,271 The change in net cash from operating activities was primarily related to the change in our net 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 license and collaboration agreements, 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 ofJune 30, 2021 , we had$2.5 billion held in cash, cash equivalents and investments. At our currently planned spending rates, we believe that our existing financial resources, together with product and royalty revenues, and the fees. 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, invest in our facilities, and expand globally, 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. 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, 2020 . InJune 2021 , we entered into we entered into a lease agreement for an approximately 258,000 square feet building complex to be constructed by the landlord on approximately 20.5 acres of land inEverett, Washington . We expect to make a significant capital investment in the facility and intend to use the building for future manufacturing, laboratory, and office space. Under the terms of the lease, base rent is payable at an initial rate of$4.0 million per year, subject to annual escalations of 3% during the initial term of 20 years. The lease commences on the date when construction and delivery of the building shell and related improvements by the landlord have been substantially completed. We have an option to renew the lease for two additional terms of ten years each. In addition, we have an option to purchase the premises in the future.
Excluding the lease agreement described above, our future minimum contractual commitments have not changed materially from the amounts previously reported.
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Critical accounting policies The preparation of financial statements in accordance with generally accepted accounting principles, or GAAP, requires us to make estimates, assumptions, and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures of contingent assets and liabilities. We believe the following critical accounting policies describe the more significant judgments and estimates used in the preparation of our financial statements. We evaluate our estimates on an ongoing basis. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form our basis for making judgments about the carrying values of assets and liabilities and the reported amounts of revenues and expenses that are not readily apparent from other sources. 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 six months endedJune 30, 2021 were consistent with those in Part II Item 7 of our Annual Report on Form 10-K for the year endedDecember 31, 2020 . 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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