UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (date of earliest event reported):
(Exact Name of Registrant as Specified in Its Charter)
| |
|
| ||
| (State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
(Address of principal executive office) (zip code)
Registrant’s telephone number, including area code:
Not Applicable
(Former name or former address, if changed since last report.)
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 |
Name of each exchange on which registered | ||
| |
|
|
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 2.02 | Results of Operations and Financial Condition. |
On October 23, 2019, TherapeuticsMD, Inc. (the “Company”) issued a press release announcing its estimated financial results for the third quarter ended September 30, 2019. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in Item 2.02 of this Current Report on Form 8-K (including the exhibits) is furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The information in Item 2.02 of this Current Report on Form 8-K (including the exhibits) shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, whether made before or after the date of this Current Report, regardless of any general incorporation language in the filing.
The Company does not have, and expressly disclaims, any obligation to release publicly any updates or any changes in its expectations or any change in events, conditions, or circumstances on which any forward-looking statement is based.
| Item 7.01 | Regulation FD Disclosure. |
On October 23, 2019, the Company issued a press release announcing the Company’s estimated financial results for its third quarter ended September 30, 2019. The information included in this Item 7.01 and in Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
Exhibit Index
| Exhibit Number |
Description of Exhibit | |||
| 99.1* |
||||
| 104 |
Cover Page Interactive Data File (the cover page tags are embedded within the Inline XBRL document). | |||
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.
| THERAPEUTICSMD, INC. | ||||
| Date: October 23, 2019 |
By: |
/s/ Daniel A. Cartwright | ||
| Daniel A. Cartwright Chief Financial Officer | ||||
Exhibit 99.1
FOR IMMEDIATE RELEASE
TherapeuticsMD Announces Estimated Third Quarter 2019 Financial Results
BOCA RATON, Fla, October 23, 2019 – TherapeuticsMD, Inc. (NASDAQ:TXMD) (the “Company”) today announced its estimates of the financial results for the third quarter ended September 30, 2019.
For the three months ended September 30, 2019, the Company estimates that its consolidated net revenue from its prescription vitamin business will range from approximately $2.50 million to $2.60 million, compared to consolidated net revenue from its prescription vitamin business of approximately $2.80 million for the three months ended June 30, 2019. For the three months ended September 30, 2019, the Company estimates that its consolidated net revenue from sales of its U.S. Food and Drug Administration approved products IMVEXXY®, BIJUVA®, and ANNOVERA® will range from approximately $5.32 million to $5.70 million, compared to consolidated net revenue from sales of IMVEXXY and BIJUVA of approximately $3.3 million for the three months ended June 30, 2019. Sales of ANNOVERA commenced in August 2019. The Company estimates that its consolidated net revenue by product for the three months ended September 30, 2019 will be as follows:
| • | IMVEXXY consolidated net revenue for the three months ended September 30, 2019 will range from approximately $4.5 million to $4.8 million, compared to approximately $3.1 million for the three months ended June 30, 2019; |
| • | BIJUVA consolidated net revenue for the three months ended September 30, 2019 will range from approximately $450,000 to $500,000, compared to approximately $134,000 for the three months ended June 30, 2019; and |
| • | ANNOVERA consolidated net revenue for the three months ended September 30, 2019 will range from approximately $375,000 to $400,000. |
The Company estimates that, as of September 30, 2019, it had approximately $155.3 million of cash and cash equivalents. As a result of the Company’s commercial sales of ANNOVERA, as of September 30, 2019, the Company had accrued a current liability of $20 million representing the milestone payment due to the Population Council under the Company’s license agreement for ANNOVERA. The Company expects to pay this milestone in the fourth quarter of 2019.
The foregoing amounts are unaudited and preliminary, and do not present all information necessary for an understanding of the Company’s financial condition as of September 30, 2019. The review of the Company’s consolidated financial statements for the three months ended September 30, 2019 is ongoing and could result in changes to these amounts due to the completion of financial closing procedures, final adjustments and other developments that may arise between now and the time the consolidated financial statements for the three months ended September 30, 2019 are finalized and publicly released. The Company’s independent registered public accounting firm, Grant Thornton LLP, has not audited, reviewed, or compiled these estimates.
TherapeuticsMD has filed a registration statement (including a prospectus) with the SEC for the offering to which this communication relates. Before you invest, you should read the prospectus in that registration statement and other documents the issuer has filed with the SEC for more
complete information about the issuer and this offering. You may get these documents for free by visiting EDGAR on the SEC Web site at www.sec.gov. Alternatively, the issuer, any underwriter or any dealer participating in the offering will arrange to send you the prospectus if you request it by calling toll-free 1-866-803-9204.
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is an innovative, leading healthcare company, focused on developing and commercializing novel products exclusively for women. Our products are designed to address the unique changes and challenges women experience through the various stages of their lives with a therapeutic focus in family planning, reproductive health, and menopause management. The company is committed to advancing the health of women and championing awareness of their healthcare issues.
Forward Looking Statements
This press release by TherapeuticsMD, Inc. may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to TherapeuticsMD’s objectives, plans and strategies as well as statements, other than historical facts, that address activities, events or developments that the company intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as “believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,” “will,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and similar expressions and are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and the company undertakes no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of the company’s control. Important factors that could cause actual results, developments and business decisions to differ materially from forward-looking statements are described in the sections titled “Risk Factors” in the company’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as reports on Form 8-K, and include the following: the company’s ability to maintain or increase sales of its products; the company’s ability to develop and commercialize IMVEXXYTM, ANNOVERATM, BIJUVATM and its hormone therapy drug candidates and obtain additional financing necessary therefor; whether the company will be able to comply with the covenants and conditions under its term loan facility; the potential of adverse side effects or other safety risks that could adversely affect the commercialization of the company’s current or future approved products or preclude the approval of the company’s future drug candidates; the length, cost and uncertain results of future clinical trials; the company’s reliance on third parties to conduct its manufacturing, research and development and clinical trials; the ability of the company’s licensees to commercialize and distribute the company’s products; the availability of reimbursement from government authorities and health insurance companies for the company’s products; the impact of product liability lawsuits; the influence of extensive and costly government regulation; the volatility of the trading price of the company’s common stock and the concentration of power in its stock ownership. PDF copies of the company’s historical press releases and financial tables can be viewed and downloaded at its website: www.therapeuticsmd.com/pressreleases.aspx.
# # #
Investor Contact
Nichol Ochsner
Vice President Investor Relations
561-961-1900 Ext. 2088
nochsner@TherapeuticsMD.com