false 0000025743 0000025743 2022-05-16 2022-05-16

 

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): May 16, 2022

 

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.)

 

951 Yamato Road, Suite 220 Boca Raton, FL 33431

(Address of Principal Executive Office) (Zip Code)

 

Registrant’s telephone number, including area code:  (561) 961-1900

 

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
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) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2).

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.

 

The information provided in Item 7.01 of this Current Report on Form 8-K is incorporated in this Item 2.02 by reference.

 

Item 7.01

Regulation FD Disclosure.

 

On May 16, 2022, the Company issued a press release announcing its financial results for the first quarter ended March 31, 2022. In addition, the Company provided a slide presentation for use during its earnings conference call.  Copies of the press release and slide presentation are furnished as Exhibits 99.1 and 99.2, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.  

 

The information in this Item 7.01 and the information contained in Exhibits 99.1 and 99.2 is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as may be expressly set forth by specific reference in any such filing, 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 9.01

Financial Statements and Exhibits.

 

(d)	Exhibits
Exhibit Index
Exhibit No.		Description
99.1		Press Release from TherapeuticsMD, Inc., dated May 16, 2022, entitled "TherapeuticsMD Announces First Quarter 2022 Financial Results."
99.2		TherapeuticsMD, Inc. Presentation dated May 16, 2022.
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.

 

Date:  May 16, 2022		THERAPEUTICSMD, INC.
		/s/ Michael C. Donegan
		Michael C. Donegan
		Interim Chief Financial Officer, Chief Accounting Officer and Vice President Finance

 

 

Exhibit 99.1

 

 

TherapeuticsMD Announces First Quarter 2022 Financial Results

 

- Quarterly total net product revenue of $19.3 million -

- ANNOVERA® TRx of 8,014, an increase of 27% over Q1 2021 -

- Announced and completed vitaCare divestiture in five weeks -

- Conference call scheduled for 4:30 p.m. ET today -

  

BOCA RATON, Fla. – May 16, 2022 – TherapeuticsMD, Inc. (“TXMD” or the “Company”) (NASDAQ: TXMD), an innovative, leading women’s healthcare company, today reported financial results for the first quarter ended March 31, 2022.

 

“Our revenue performance during the quarter was impacted by ANNOVERA manufacturing challenges as anticipated, but we believe these obstacles peaked in the first quarter of 2022 and expect incremental improvement as the year progresses. I’m also pleased to report that the $150 million divestiture of vitaCare that we announced during the quarter was driven to a successful conclusion, closing just five weeks following the announcement,” said Hugh O’Dowd, CEO of TherapeuticsMD.

 

“With our increased focus and optimized sales organization, we believe that we will now be able to properly leverage all three of our assets and are confident these products can play a significant role in the marketplace,” concluded O’Dowd.

 

First Quarter 2022 Financial Results and Business Highlights

 

ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system)

 

IMVEXXY^® (estradiol vaginal inserts)

 

BIJUVA^® (estradiol and progesterone) capsules

 

 

---

 

 

Cost of Goods Sold and Gross Margin

 

Operating Expense, Net Loss and Related Information

 

Balance Sheet 

  

Conference Call and Webcast Details 

TherapeuticsMD will host a conference call and live audio webcast today at 4:30 p.m. ET to discuss these financial results and provide a business update. 

 

 

A live webcast and audio archive for the event may be accessed on the home page or from the “Investors & Media” section of the TherapeuticsMD website at www.therapeuticsmd.com. Please connect to the website prior to the start of the presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast will be archived on the website for at least 30 days. In addition, a digital recording of the conference call will be available for replay beginning two hours after the call's completion and for at least 30 days with the dial-in 855-859-2056 or international 404-537-3406 and Conference ID: 3179996.

 

Please see the Full Prescribing Information, including indication and Boxed WARNING, for each TherapeuticsMD product as follows:

  

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 effects of the COVID-19 pandemic; how the proceeds from the divestiture of the company’s vitaCare business will be utilized; the company’s ability to maintain or increase sales of its products; the company’s ability to develop and commercialize IMVEXXY®, ANNOVERA®, and BIJUVA® and obtain additional financing necessary therefor; whether the company will be able to comply with the covenants and conditions under its term loan facility and the company’s ability to refinance such facility; the effects of supply chain issues on the supply of the company’s products; 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; whether the FDA will approve the manufacturing supplement for ANNOVERA; the company’s ability to protect its intellectual property, including with respect to the Paragraph IV notice letters the company received regarding IMVEXXY; 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 ability of the company’s marketing contractors to market ANNOVERA; 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 impact of leadership transitions; the volatility of the trading price of the company’s common stock and the concentration of power in its stock ownership.

 

 

- Financial Statements to Follow -

 

---

 

 

TherapeuticsMD, Inc. and Subsidiaries

Consolidated Balance Sheets

(Unaudited - in thousands, except per share data)

 

---

 

 

TherapeuticsMD, Inc. and Subsidiaries

Consolidated Statements of Operations

(Unaudited - in thousands, except per share data)

 

---

 

 

TherapeuticsMD, Inc. and Subsidiaries

Consolidated Statements of Cash Flows

(Unaudited - in thousands)

 

 

CONTACT:

 

Building the Premier Women’s Health Company Q1 2022 Earnings May 16, 2022 Exhibit 99.2

Forward-Looking Statements This presentation 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 effects of the COVID-19 pandemic; how the proceeds from the divestiture of the company’s vitaCare business will be utilized; the company’s ability to maintain or increase sales of its products; the company’s ability to develop and commercialize IMVEXXY®, ANNOVERA®, and BIJUVA® and obtain additional financing necessary therefor; whether the company will be able to comply with the covenants and conditions under its term loan facility and the company’s ability to refinance such facility; the effects of supply chain issues on the supply of the company’s products; 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; whether the FDA will approve the manufacturing supplement for ANNOVERA; the company’s ability to protect its intellectual property, including with respect to the Paragraph IV notice letters the company received regarding IMVEXXY; 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 ability of the company’s marketing contractors to market ANNOVERA; 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 impact of leadership transitions; the volatility of the trading price of the company’s common stock and the concentration of power in its stock ownership. 2

3 Hugh O’Dowd CEO

4 Q1 2022 Financial Overview

$18.7 Quarterly Revenue (YoY) Quarterly Revenue Trends Millions Q1-22 Highlights Total net revenue decreased 3% in Q1-22 vs Q1-21, but increased 4% vs Q4-21 Total net product revenue decreased 4% in Q1-22 vs Q1-21, but increased 1% vs Q4-21 ANNOVERA net revenue decreased 3% in Q1-22 vs Q1-21 and was impacted by production and supply issues, but increased 9% vs Q4-21 BIJUVA net revenue increased 5% in Q1-22 vs Q1-21, but decreased 5% vs Q4-21 IMVEXXY net revenue was flat in Q1-22 vs Q1-21, but increased 5% vs Q4-21 $19.3 5 $19.9

Financial Results: Comparison Q1 2022 to Q1 2022 to Q4 2021 In April, certain proceeds from the vitaCare divestiture were used to paydown the debt; April 30th debt balance was $89M. Gross margin of 75% in Q1-22 relatively consistent Q1-21 and Q4-21. Operating expenses in Q1-22 decreased $3.8M from Q1-21 and $8.6M from Q4-21. Net loss in Q1-22 increased $9.6M from Q1-21 and $6.1M from Q4-21. Net loss in Q1-22 included a $8.4 million loss on extinguishment of debt and higher financing fees amortization as compared to Q1-21 and Q4-21. Net cash used in operating activities in Q1-22 decreased $8.9M from Q1-21 and $10.0M from Q4-21. 6 (1) Balance Sheet as of quarter end. Comparison of Key Financial Statement Items [$1,000’s]

7 Q1 2022 Commercial Overview

Call Activity Highlights 9.2 calls per day 6,271 targets reached (87%) 10,868 calls to targets (84%) *Source: Veeva; reflects Mar22 call activity, excluding vacancies and new hires in training 8

Available ANNOVERA vs. Prescriptions 9 Cumulative Shipments to Prescriptions Filled

ANNOVERA Quarterly TRx +27% vs. Q121 Source: Symphony Metys – December 2021 Performance 10

ANNOVERA Prescribers: Launch to Date Source: Symphony Metys – April 2022; 5 prescribers in Q319                New prescribers defined as not having written Annovera in prior periods 11

IMVEXXY Monthly TRx Source: Symphony Metys – April 2022 12

BIJUVA Quarterly TRx Source: Symphony Metys – April 2022 13