TherapeuticsMD Announces First Quarter 2019 Financial Results

TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading women’s
healthcare company, today announced its commercial and corporate update
for the first quarter ended March 31, 2019.

“We are pleased with our recent progress on achieving several business
objectives, which include the on-time launch of BIJUVA, the expansion of
our sales force to 200 sales representatives who are now selling BIJUVA
and IMVEXXY, the continued strong prescriptions and refills for IMVEXXY,
and the significant strengthening of the company’s financial position
with the completion of our $300 million non-dilutive term loan facility,
which also increases our flexibility to support the launches of BIJUVA
and ANNOVERA,” said Robert G. Finizio, Chief Executive Officer of
TherapeuticsMD.

IMVEXXY Continues Strong Prescriptions and Refills

IMVEXXY prescription growth continues as highlighted by a record month
in April 2019 with approximately 31,200 prescriptions dispensed and paid
for by patients. Approximately 75,000 prescriptions of IMVEXXY were
dispensed and paid for by patients during the first quarter of 2019.
This is an increase of approximately 58% in prescription volume for the
first quarter of 2019 as compared to the fourth quarter of 2018. Strong
refill rates continue to indicate that women are having a positive
experience with IMVEXXY.

Through April 30, 2019, the company achieved unrestricted coverage for
IMVEXXY with seven of the top ten commercial payers of VVA products. One
of these plans, United Healthcare, began adjudication on March 1, 2019.
The company also achieved unrestricted Medicare Part D coverage on
United Healthcare and Kaiser.

Summary of First Quarter 2019 Financial Results

Net revenues for the first quarter of 2019 were approximately $3.9
million, compared with net revenues of approximately $3.8 million for
the prior year’s quarter. Net revenues for IMVEXXY for the first quarter
of 2019 were approximately $2.0 million and were greatly affected by the
company’s patient savings program introduced to launch IMVEXXY, which
allows eligible patients to access the product at a reasonable cost of
no more than $35 per prescription regardless of insurance coverage. The
company expects revenues related to IMVEXXY to improve as commercial
payer coverage for IMVEXXY increases and insurance plans complete the
process needed to adjudicate IMVEXXY prescriptions at pharmacies.

Net revenues from the company’s prescription prenatal vitamin business
were approximately $1.9 million for the first quarter of 2019, compared
with approximately $3.8 million for the first quarter of 2018. A portion
of the lower revenue was created by a price increase in the first
quarter of 2019, causing some customers to increase purchases of the
company’s prescription prenatal vitamins in the fourth quarter of 2018.

R&D expenses for the first quarter of 2019 were approximately $6.3
million, compared with approximately $7.0 million for the prior year’s
quarter. The decrease in first quarter 2019 R&D expenses was primarily a
result of the completion of the REPLENISH trial for BIJUVA and the FDA
approval of IMVEXXY and BIJUVA, partially offset by scale-up and
manufacturing activities for BIJUVA before FDA approval, as well as
increased pre-clinical work to support our product pipeline.

Sales, general and administrative (SG&A) expenses for the first quarter
of 2019 increased to approximately $34.9 million, compared with
approximately $20.8 million for the prior year’s quarter. The increase
in first quarter 2019 sales and marketing expenses was primarily a
result of increased expenses associated with sales and marketing efforts
to support the launch and commercialization of IMVEXXY and BIJUVA,
including costs related to sales force expansion, outsourced sales
personnel and their related expenses, physician education and product
samples, and other expenses related to product commercialization. The
company expects sales and marketing expenses to continue to increase as
it continues the launch of BIJUVA, prepares for the launch of ANNOVERA
and continues to support its growing business and commercialization of
its products.

Net loss for the first quarter of 2019 was approximately $39.5 million,
or $0.16 per basic and diluted share, compared with approximately $24.4
million, or $0.11 per basic and diluted share, for the first quarter of
2018.

Balance Sheet

As of March 31, 2019, the company’s cash on hand totaled approximately
$122.9 million, compared with approximately $161.6 million at December
31, 2018. Total outstanding debt, net of issuance costs, was
approximately $73.5 million as of March 31, 2019.

In April 2019, the company entered into a financing agreement for a $300
million non-dilutive term loan facility with TPG Sixth Street Partners
(TSSP). The initial tranche of $200 million was drawn on April 24, 2019,
with additional tranches of $50 million available to the company upon
the designation of ANNOVERA as a new category of contraception by the
U.S. Food and Drug Administration on or prior to December 31, 2019 and
another $50 million available to the company upon achieving $11 million
in net revenues from IMVEXXY, ANNOVERA and BIJUVA for the fourth quarter
of 2019. A portion of the proceeds from the initial tranche of the TSSP
facility was used to repay all amounts outstanding under the company’s
prior credit facility.

Conference Call and Webcast Details

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

Date: Monday, May 6, 2019

Time: 4:30 p.m. ET

Telephone Access (US): 866-665-9531

Telephone Access (International): 724-987-6977

Access Code for All Callers: 5799911

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:
5799911.

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

• IMVEXXY (estradiol vaginal inserts) at https://imvexxy.com/pi.pdf
• BIJUVA (estradiol and progesterone capsules) at https://www.bijuva.com/pi.pdf
• ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) at www.annovera.com/pi.pdf

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. To learn
more about TherapeuticsMD, please visit www.therapeuticsmd.com
or follow us on Twitter: @TherapeuticsMD and on Facebook: TherapeuticsMD.

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 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; 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 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.

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