Milestones under the GSK Agreement are as follows:
|
|
|
|
|
|
|
PD-1
(Jemperli/Dostarlimab) |
Milestone Event |
|
Amount |
|
Quarter Recognized |
Initiated in vivo toxicology studies using good laboratory practices (GLPs) |
|
$1.0M |
|
Q2’15 |
IND clearance from the FDA |
|
$4.0M |
|
Q1’16 |
Phase 2 clinical trial initiation |
|
$3.0M |
|
Q2’17 |
Phase 3 clinical trial initiation - first indication |
|
$5.0M |
|
Q3’18 |
Phase 3 clinical trial initiation - second indication |
|
$5.0M |
|
Q2’19 |
Filing of the first BLA(1) - first indication |
|
$10.0M |
|
Q1’20 |
Filing of the first MAA(2) - first indication |
|
$5.0M |
|
Q1’20 |
Filing of the first BLA - second indication |
|
$10.0M |
|
Q1’21 |
First BLA approval - first indication |
|
$20.0M |
|
Q2’21 |
First MAA approval - first indication |
|
$10.0M |
|
Q2’21 |
First BLA approval - second indication |
|
$20.0M |
|
Q3’21 |
Filing of the first MAA - second indication(3) |
|
$5.0M |
|
— |
First MAA approval - second indication(3) |
|
$10.0M |
|
— |
First commercial sales milestone(3) |
|
$15.0M |
|
Q3’24 |
Second commercial sales milestone(3) |
|
$25.0M |
|
Q4’24 |
Third commercial sales milestone(3) |
|
$50.0M |
|
Q3’25 |
Fourth commercial sales milestone(4) |
|
$75.0M |
|
Q4’25 |
|
|
|
|
|
Milestones recognized through June 30, 2026 |
|
$258.0M |
|
— |
Milestones that may be recognized in the future |
|
$15.0M |
|
— |
(1)Biologics License Application (“BLA”) (2)Marketing Authorization Application (“MAA”) (3)For Jemperli, the filing and approval of the first MAA for a second indication and first three commercial sales milestones are included as part of the royalty monetization agreement with Sagard (as defined below). For more information, see Note 5. Cash is generally received within 30 days of milestone achievement. (4)For Jemperli, we retained the rights to a $75.0 million sales milestone when Jemperli annual net sales exceeded $1 billion. We received the cash milestone payment in December 2025. We are also eligible to receive a 10% royalty on net sales. The Separation and Distribution Agreement provides that any and all rights to receive milestone payments under the Vanda License Agreement will be allocated to First Tracks Biotherapeutics as follows:
|
|
|
|
|
Milestone Event |
|
Amount |
|
Quarter Recognized |
FDA regulatory approval for marketing of first licensed product in the USA for the treatment of active flares in GPP |
|
$5.0M |
|
— |
Regulatory approval for marketing of the first licensed product in the EU |
|
$5.0M |
|
— |
Commercial sales first exceed $100.0 million |
|
$25.0M |
|
— |
|
|
|
|
|
Milestones recognized through June 30, 2026 |
|
— |
|
— |
Milestones that may be recognized in the future |
|
$35.0M |
|
— |
|