Fourth Quarter & Full Year 2022 Financial & Business Update
2023 is an Important Data and Regulatory Year with Multiple
Anticipated Milestones
PADCEV
enfortumab vedotin-ejfv
Invection for IV infusion 20 mg & 30 movials
Potential FDA accelerated
approval in 1L MUC cis-
ineligible patients; PDUFA
date April 21, 2023
TUKYSA
tucatinib
50 mg 150 mg tablets
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ADCETRIS
brentuximab vedotin for injection
tivdak
tisotumab vedotir-litv
to injection 40 mg
Potential FDA
accelerated approval in
2L+ mCRC; PDUFA
date Jan 19, 2023
✓
Pipeline
Initial solid tumor data
in combination with
Keytruda (1H23)
Complete patient
enrollment for innovaTV
301 in 2L+ r/mCC
confirmatory trial (1H23)
Additional Ph1 data for
SGN-B6A (1H23)
Initial Ph1 data for SGN-
B7H4V (2H23)
Initial EV-104 NMIBC
and EV-202 other solid
tumor data (1H23)
Topline data for
HER2CLIMB-02 in 2L+
mBC1
Topline data for EV-302
in 1L mUC estimated by
YE231
Initial data from basket
study in other HER2-
expressing tumors
(1H23)
Additional product
launches ex-US
Additional product
launches ex-US
Potential FDA approval
of addition of OS data
to HL label; PDUFA
date June 29, 2023
(1H23)
Additional innovaTV
207 data in H&N cancer
(1H23)
Topline data for
innovaTV 301 in 2L+
cervical cancer
expected by YE231
Initial Ph2 data for LV in
other solid tumors
(2H23)
Initiate Ph1 trials for
multiple programs²
Preclinical data for
CEACAM5-targeted ADC
partnered with Sanofi
(1H23)
Seagen 1 Based on study assumptions; additional study details can be found at clinicaltrials.gov; 2 Timing of Ph1 trial initiations will vary based on program;
Completed
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