XML 30 R17.htm IDEA: XBRL DOCUMENT v3.22.1
Revenue
12 Months Ended
Dec. 31, 2021
Disaggregation Of Revenue [Abstract]  
Revenue

11.

Revenue

Disaggregated revenue

The following table provides information about disaggregated revenue by product mix and service (in thousands):

 

 

2021

 

 

2020

 

 

2019

 

Product revenue:

 

 

 

 

 

 

 

 

 

 

 

 

ANNOVERA

 

$

37,943

 

 

$

19,611

 

 

$

6,167

 

IMVEXXY

 

 

31,533

 

 

 

27,139

 

 

 

16,252

 

BIJUVA

 

 

10,579

 

 

 

6,354

 

 

 

1,836

 

Prescription vitamin

 

 

5,725

 

 

 

9,768

 

 

 

9,886

 

Product revenue, net

 

 

85,780

 

 

 

62,872

 

 

 

34,141

 

License revenue

 

 

1,171

 

 

 

2,000

 

 

 

15,506

 

Total revenue, net

 

$

86,951

 

 

$

64,872

 

 

$

49,647

 

 

License agreements with customers

Knight license agreement

Pursuant to the terms of the Knight License Agreement, in 2020, Knight paid us $2.0 million in milestone fees upon the first regulatory approval in Canada for IMVEXXY and BIJUVA, and is required to pay us sales milestone fees based upon certain aggregate annual sales in Canada and Israel of each of IMVEXXY and BIJUVA and royalties based on aggregate annual sales of each of IMVEXXY and BIJUVA in Canada and Israel.

We may terminate the Knight License Agreement if Knight does not submit all regulatory applications, submissions and/or registrations required for regulatory approval to use and commercialize IMVEXXY and BIJUVA in Canada within certain specified time periods. We also may terminate the Knight License Agreement if Knight challenges our patents. Either party may terminate the Knight License Agreement for any material breach by the other party that is not cured within certain specified time periods or if the other party files for bankruptcy or other related matters. As part of the Knight License Agreement, Knight is prohibited from exporting IMVEXXY and BIJUVA to the United States.

As of December 31, 2021, no IMVEXXY or BIJUVA sales have been made through the Knight License Agreement.

Theramex license agreement

Under the terms of the Theramex License Agreement, Theramex paid us EUR 14 million, or $15.5 million, in cash as an upfront fee in August 2019. Within thirty days of signing the Theramex License Agreement, we provided Theramex the regulatory materials and clinical data that were necessary for Theramex to obtain marketing authorizations and other applicable regulatory approvals for commercializing BIJUVA and IMVEXXY. In 2019, at a point in time when Theramex was able to use and benefit from the license which was when the knowledge transfer of regulatory documents occurred, we recognized the revenue related to the upfront fee, which was a non-refundable payment.

In 2021, we received additional milestone payments comprised of an aggregate of EUR 1.0 million, or $1.2 million, in regulatory milestone payments based on regulatory approvals for BIJUVA in certain specified markets. Additionally, in December 2021, we received EUR 0.5 million, or $0.6 million, in additional upfront payments for the license grants of IMVEXXY in Brazil and Mexico. The additional upfront payment for the license grants of IMVEXXY in Brazil and Mexico may be returned to Theramex under certain conditions if IMVEXXY fails to obtain marketing authorization in one of Brazil or Mexico within a prespecified period. Accordingly, the additional upfront payment for the license grants of IMVEXXY in Brazil and Mexico was recorded as other non-current liabilities as of December 31, 2021 in the accompanying balance sheets.

We are eligible to receive additional sales milestone payments up to an aggregate of EUR 27.5 million in sales milestone payments to be paid in escalating tranches based on Theramex first attaining certain aggregate annual net sales milestones of BIJUVA and IMVEXXY outside of the U.S., excluding Canada and Israel (collectively the “Theramex Territory”) ranging from EUR 25 million to EUR 100 million. We are also entitled to receive quarterly royalty payments at a rate of 5% on net sales of BIJUVA and IMVEXXY in the Theramex Territory. Theramex is responsible for all regulatory and commercial activities for BIJUVA and IMVEXXY in the Theramex Territory.

Theramex may sublicense its rights to commercialize BIJUVA and IMVEXXY in the Theramex Territory, except for certain specified markets. We may terminate the Theramex License Agreement if Theramex does not submit all regulatory applications, submissions

and/or registrations required for regulatory approval to use and commercialize BIJUVA and IMVEXXY within certain specified time periods. We also may terminate the Theramex License Agreement if Theramex challenges our patents. Either party may terminate the Theramex License Agreement for any material breach by the other party that is not cured within certain specified time periods or if the other party files for bankruptcy or other related matters.

In 2021, we recorded BIJUVA sales of $1.4 million made through the Theramex License Agreement. As of December 31, 2021, no IMVEXXY sales have been made through the either of the licensing agreements.