TherapeuticsMD Announces First Quarter 2020 Financial Results - 1Q20 total net product revenue of $12.3 million exceeded Wall Street consensus- - Significantly reducing operating expenses, while m

TherapeuticsMD, Inc. 8-K

TherapeuticsMD Announces First Quarter

2020 Financial Results

- 1Q20 total net product revenue of $12.3 million

exceeded Wall Street consensus-

- Significantly reducing operating expenses,

while maintaining goal of achieving EBITDA breakeven in 2021-

-In discussions with TPG Sixth Street Partners

to defer the scheduled start of quarterly revenue

covenants due to COVID-19-

-First Orange Book listed patent for ANNOVERA

issued providing potential extended exclusivity to 2039-

-Strengthened board of directors with diverse

- Conference call scheduled for 8:30 a.m. ET

May 6, 2020 - TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading women's healthcare Company, today

reported financial results for the first quarter ended March 31, 2020.

"I would like to thank our team for delivering

a successful quarter during a challenging time. We have made significant progress across the business," said Robert G. Finizio,

Chief Executive Officer of TherapeuticsMD. "We delivered a solid quarter in revenue. Recently, we extended the value of our

lead asset, ANNOVERA, with the first Orange Book listed patent, and revised our strategic priorities and significantly reduced

our operating cost structure, bringing us closer to achieving EBITDA break even in 2021."

First Quarter & Recent Highlights

First Quarter 2020 Revenue Performance

For the quarter ended March 31,

2020, net product revenue was $12.3 million compared to $15.9 million for the prior quarter.

Net product revenue for the quarter

was significantly affected by the COVID-19 pandemic for all product sales. Though ANNOVERA was commercially launched in early March

of 2020, the Company subsequently paused the launch due to the COVID-19 pandemic. Net product revenue of $12.3 million for the

quarter ended March 31, 2020 included a slight increase in IMVEXXY revenue offset by a decrease in net revenues for ANNOVERA, BIJUVA,

and prenatal vitamins. This net product revenue was comprised of sales of IMVEXXY of $6.4 million, BIJUVA of $1.1 million, ANNOVERA

of $2.3 million, and prenatal vitamins of $2.5 million. The decrease in ANNOVERA net revenue was due to the decline in unit sales,

which was largely due to the paused launch in March 2020 as a result of the COVID-19 pandemic. The decrease in BIJUVA net revenue

was due primarily to the decrease in revenue per unit while the decrease in net revenue related to the Company's prenatal

vitamins was due to a decline in units sold when compared to the quarter ended December 31, 2019.

Net revenue for IMVEXXY and BIJUVA

has been greatly affected by the Company's co-pay assistance programs introduced to provide products at a reasonable cost

regardless of insurance coverage. The Company expects net product revenue to improve as commercial and Medicare payor coverage

increases, and the plans complete the process needed to adjudicate IMVEXXY, BIJUVA, and ANNOVERA prescriptions at pharmacies.

Expense, EPS and Related Information

Research and Development (R&D) expenses

for the first quarter of 2020 were $3.3 million compared with $4.4 million for the prior quarter. R&D expenditures have been

reduced as the Company refocused resources towards launching its approved drugs. Though the Company continued to deploy adequate

resources to develop its drug pipeline, continue stability testing and validation on its drugs, develop and validate secondary

manufacturers, prepare regulatory submissions, and work with regulatory authorities on existing submissions, the Company is committed

to refocusing resources to complete the launch of ANNOVERA and continue the commercialization of its other FDA approved products.

SG&A expenses increased to $57.0 million

for the first quarter of 2020 compared with $52.7 million for the prior quarter. The increase in SG&A expenses for first quarter

2020 was primarily a result of higher expenses associated with sales and marketing efforts to support the significant initiatives

related to the launch of ANNOVERA in March 2020, which was subsequently paused as a result of the COVID-19 pandemic. Additionally

these higher expenses related to the continued commercialization of BIJUVA and IMVEXXY, which was also pre-empted by the COVID-19

pandemic. In the case of all products the increased costs related to advertising expenses and spend on consumer media while certain

one-time launch expenses related to the paused launch of ANNOVERA were also incurred. Near the end of the quarter, the Company

pulled back on a large portion of the marketing spend due to COVID-19, which will result in reduced costs in the second quarter

that will continue to play out in subsequent quarters.

Human resources costs, including salaries,

benefits and taxes, for the three months ended March 31, 2020 decreased compared to the quarter ended December 31, 2019. Other

operating expenses for the three months ended March 31, 2020 remained flat, when compared to the three months ended December 31,

2019, due to the Company's effort to focus spend on commercialization of its products. The Company expects total operating

costs to be significantly reduced for the remainder of the year.

Net loss for the first quarter of 2020 increased

to $56.8 million, or $0.21 per basic and diluted share, compared with $49.4 million, or $0.19 per basic and diluted share, for

the fourth quarter of 2019.

As of March 31, 2020, the Company's cash

on hand totaled $170.1 million, compared with approximately $160.8 million at December 31, 2019.

Total outstanding debt, net of issuance costs,

was approximately $243.4 million as of March 31, 2020 compared to $194.6 million as of December 31, 2019. The change is due to

the drawdown of the $50 million tranche for meeting the fourth quarter 2019 revenue draw trigger.

Conference Call and Webcast Details

TherapeuticsMD will host a conference

call and live audio webcast today at 8:30 a.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: 5832796.

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 Company's ability to

protect the intellectual property related to its products; the effects of the COVID-19 pandemic; the Company's ability to

maintain or increase sales of its products; the Company's ability to develop and commercialize IMVEXXY , ANNOVERA ,

BIJUVA 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, including the conditions to draw an additional