Current Report Filing (8-k)
June 07 2019 - 7:16AM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event
reported): June 6, 2019
TherapeuticsMD, Inc.
|
(Exact Name of Registrant as Specified in its Charter)
|
Nevada
|
|
001-00100
|
|
87-0233535
|
(State or other
jurisdiction of incorporation)
|
|
(Commission File Number)
|
|
(IRS Employer
Identification No.)
|
6800 Broken Sound Parkway NW, Third Floor
Boca Raton, FL 33487
|
(Address of principal executive offices) (Zip Code)
|
Registrant's telephone number, including area
code: (561) 961-1900
Check the appropriate box below if
the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section
12(b) of the Act:
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which registered
|
Common Stock, par value $0.001 per share
|
TXMD
|
The Nasdaq Stock Market LLC
|
Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230-405 of this chapter) or Rule 12b-2
of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
☐
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange Act.
☐
Item 1.01. Entry into a Material Definitive Agreement.
On June 6, 2019,
TherapeuticsMD, Inc., a Nevada corporation (the “Company”), entered into a Licensing and Supply Agreement (the “Licensing
Agreement”) with Theramex HQ UK Limited, a company formed under the laws of England (“Theramex”), pursuant to
which the Company granted Theramex an exclusive, perpetual license to commercialize for human use the Company’s FDA-approved
products BIJUVA™ (estradiol and progesterone capsules) and IMVEXXY® (estradiol vaginal inserts) outside of the United
States, except for Canada and Israel, for which the Company has licensed BIJUVA™ and IMVEXXY® to Knight Therapeutics
(such licensed area to Theramex, the “Territory”).
Pursuant to the
terms of the Licensing Agreement, Theramex will pay the Company an upfront fee of EUR 14 million in cash within 60 days of entering
into the Licensing Agreement. The Company is also eligible to receive up to an additional EUR 29.5 million in cash milestone payments,
comprised of (i) an aggregate of EUR 2 million in regulatory milestone payments based on regulatory approvals for each of BIJUVA™
and IMVEXXY® in certain specified markets and (ii) 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 in the Territory
ranging from EUR 25 million to EUR 100 million. The Company is also entitled to receive quarterly royalty payments based on net
sales of BIJUVA™ and IMVEXXY® in the Territory.
Theramex will be
responsible for all regulatory and commercial activities in the Territory related to BIJUVA™ and IMVEXXY®. Theramex has
agreed to submit all regulatory applications, submissions and/or registrations required for regulatory approval to use and commercialize
BIJUVA™ and IMVEXXY® in certain specified markets within certain specified time periods and the Company may terminate
the Licensing Agreement if Theramex does not submit certain of such regulatory applications, submissions and/or registrations.
The Company may also terminate the Licensing Agreement if Theramex challenges the Company’s patents. Either party may terminate
the Licensing 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.
Theramex may sublicense
its rights to commercialize BIJUVA™ and IMVEXXY® in the Territory, except for certain specified markets.
Pursuant to the
terms of the Licensing Agreement, the Company has agreed to supply, or cause to be supplied, BIJUVA™ and IMVEXXY® to
Theramex.
The Company and
Theramex have agreed to form a joint product committee responsible for advising and overseeing activities under the Licensing Agreement.
The foregoing summary
of the terms of the Licensing Agreement does not purport to be complete and is subject to, and qualified in its entirety by, the
full text of the Licensing Agreement, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form
10-Q for the quarter ending June 30, 2019.
Item 7.01
Regulation FD Disclosure.
On June 7, 2019,
the Company issued a press release announcing that it had entered into the Licensing Agreement. A copy of the press release is
attached as Exhibit 99.1 hereto.
The information
being furnished pursuant to Item 7.01 of this Current Report on Form 8-K and in Exhibit 99.1 hereto shall not be deemed to be “filed”
for the purpose of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that
section, nor will any of such information or exhibits be deemed incorporated by reference into any filing under the Securities
Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as expressly set forth by specific reference
in such filing.
Item 9.01 Financial Statements and Exhibits.
(d)
Exhibits.
Exhibit Index
Exhibit Number
|
|
Description
|
99.1
|
|
Press Release, dated June 7, 2019, issued by TherapeuticsMD, Inc. titled TherapeuticsMD and Theramex Enter into Exclusive License and Supply Agreement to Commercialize BIJUVA™ and IMVEXXY® Outside the United States.
|
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: June 7, 2019
|
THERAPEUTICSMD, INC.
|
|
|
|
|
|
By:
|
/s/ Daniel A. Cartwright
|
|
Name:
|
Daniel A. Cartwright
|
|
Title:
|
Chief Financial Officer
|
TherapeuticsMD (NASDAQ:TXMD)
Historical Stock Chart
From Aug 2024 to Sep 2024
TherapeuticsMD (NASDAQ:TXMD)
Historical Stock Chart
From Sep 2023 to Sep 2024