TherapeuticsMD Announces Oral and Poster Presentations on BIJUVA™ and ANNOVERA™ at the Endocrine Society 2019 Annual Meeting

TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading women’s
healthcare company, today announced the schedule of presentations on
BIJUVA™ (estradiol and progesterone capsules, 1 mg/100 mg) and ANNOVERA™
(segesterone acetate/ethinyl estradiol vaginal system) at the Endocrine
Society 2019 Annual Meeting in New Orleans, on March 23-26, 2019.

“Data from the REPLENISH Phase 3 trial for BIJUVA showed improvements in
hot flushes, night sweats, sweating, and quality of sleep. We are
pleased to continue to present positive clinical data on BIJUVA in
menopause quality of life (MENQOL) assessments, including difficulty in
sleeping, which is a common complaint in postmenopausal women with
vasomotor symptoms,” said TherapeuticsMD Chief Medical Officer Sebastian
Mirkin, M.D. “The REPLENISH data also showed a low incidence of vaginal
bleeding. Vaginal bleeding associated with hormone therapy is the most
common reason for discontinuation of treatment.”

BIJUVA is the first and only FDA-approved, bio-identical hormone therapy
combination of estradiol and progesterone in a single, oral capsule for
the treatment of moderate-to-severe vasomotor symptoms (commonly known
as hot flashes or flushes) due to menopause in women with a uterus.
Please see the Important Safety Information, including Boxed Warning,
for BIJUVA below.

Data on ANNOVERA, a contraceptive vaginal system that contains a novel
progestin, segesterone acetate, demonstrated potent antiovulatory
effects in preventing pregnancy without the androgenic, estrogenic or
glucocorticoid side effects that are often associated with other
contraceptive hormone products.

“We are enthusiastic about the ANNOVERA data that confirms this new
progestin is highly effective and comparable to the most effective birth
control methods already on the market today, while avoiding daily
fluctuations in hormone levels given its controlled release, helping to
provide excellent cycle control,” said Dr. Brian Bernick, Co-founder and
Director of TherapeuticsMD.

ANNOVERA is the first long-acting prescription birth control that is
patient-controlled, procedure-free and reversible. This small, soft,
flexible ring prevents ovulation for an entire year (13 cycles) and can
be inserted and removed by a woman at her discretion in repeated
four-week cycles (remaining in place continuously for three weeks
followed by removal for one week). Please see the Important Safety
Information, including Boxed Warning, for ANNOVERA below.

The posters and presentations will be made available on the Investors &
Media section of the company’s website at www.therapeuticsmd.com.

Poster Presentations

Date: Saturday, March 23
Time and Location: 1:00-3:00
PM, Ernest N. Morial Convention Center, Expo Hall
Title: Combined
Bioidentical Estradiol and Progesterone Capsules Improved Quality of
Sleep in Postmenopausal Women with Vasomotor Symptoms
Authors:
N Santoro, G Constantine, R Kagan, S Graham, B Bernick, S Mirkin

Date: Saturday, March 23
Time and Location: 1:00-3:00
PM Ernest N. Morial Convention Center, Expo Hall
Title: Bioidentical
Estradiol and Progesterone Improved Hot Flushes, Night Sweats and
Sweating
Authors: J Liu, AM Kaunitz, JA Simon, B
Bernick, S Mirkin

Date: Saturday, March 23
Time and Location: 1:00-3:00
PM, Ernest N. Morial Convention Center, Expo Hall
Title: Predictors
of Vaginal/Uterine Bleeding with Oral TX-001HR (Estrogen and
Progesterone)
Capsules Taken for Menopausal Vasomotor Symptoms
Authors: G
Constantine, SR Goldstein, JH Pickar, S Graham, B Bernick, S Mirkin

Date: Saturday, March 23
Time and Location: 1:00-3:00
PM, Ernest N. Morial Convention Center, Expo Hall
Title: A
Novel 1-Year Contraceptive Vaginal System Delivering Segesterone
Acetate and Ethinyl Estradiol: Effects on Lipids and other
Hepatic Proteins
Authors: DF Archer, MA Thomas, R
Sitruk-Ware, J Liu, B Bernick, S Mirkin, R Merkatz, N Kumar, DL Blithe

Date: Saturday, March 23
Time and Location: 1:00-3:00
PM, Ernest N. Morial Convention Center, Expo Hall
Title: Nonsmokers
Benefit from Lower Doses of an Estradiol/Progesterone Combination:
Results of the REPLENISH Trial
Authors: G Constantine, S
Graham, B Bernick, S Mirkin

Oral Presentation

Date: Tuesday, March 26
Time and Location: 9:45-11:30
AM, OR33-Modulation of HGP Axis in the Female
Title: Low
Systemic Levels of Segesterone Acetate are Required to Inhibit Ovulation
in Women
Authors: DF Archer, R Sitruk-Ware, S Mirkin, V
Brache, RB Merkatz, N Kumar

BIJUVA IMPORTANT SAFETY INFORMATION

BIJUVA is a combination of an estrogen and progesterone indicated in a
woman with a uterus for the treatment of moderate-to-severe vasomotor
symptoms due to menopause.

Contraindications

• BIJUVA is contraindicated in women with any of the following
  conditions: Undiagnosed abnormal genital bleeding; Known, suspected,
  or history of cancer of the breast; Known or suspected
  estrogen-dependent neoplasia; Active DVT, PE, or history of these
  conditions; Active arterial thromboembolic disease (for example,
  stroke, MI), or a history of these conditions; Known anaphylactic
  reaction, angioedema, or hypersensitivity to BIJUVA or any of its
  ingredients; Known liver impairment or disease; Known protein C,
  protein S, or antithrombin deficiency, or other known thrombophilic
  disorders.

Warnings & Precautions

• An increased risk of PE, DVT, stroke, and MI has been reported with
  estrogen plus progestin therapy. Should these occur or be suspected,
  therapy should be discontinued immediately. Risk factors for arterial
  vascular disease and/or venous thromboembolism (VTE) should be managed
  appropriately.
• The WHI substudy of daily estrogen plus progestin after a mean
  follow-up of 5.6 years reported an increased risk of invasive breast
  cancer. Observational studies have also reported an increased risk of
  breast cancer for estrogen plus progestin therapy after several years
  of use. The risk increased with duration of use an appeared to return
  to baseline over about 5 years after stopping treatment (only the
  observational studies have substantial data on risk after stopping).
  The use of estrogen plus progestin therapy has been reported to result
  in an increase in abnormal mammograms requiring further evaluation.
• Endometrial hyperplasia (a possible precursor to endometrial cancer)
  has been reported to occur at a rate of approximately less than one
  percent with BIJUVA. Clinical surveillance of all women using estrogen
  plus progestin therapy is important. Adequate diagnostic measures
  should be undertaken to rule out malignancy in postmenopausal women
  with undiagnosed persistent or recurring abnormal genital bleeding.
• The WHI estrogen plus progestin substudy reported a statistically
  non-significant increased risk of ovarian cancer. A meta-analysis of
  17 prospective and 35 retrospective epidemiology studies found that
  women who used hormonal therapy for menopausal symptoms had an
  increased risk for ovarian cancer. The exact duration of hormone
  therapy use associated with an increased risk of ovarian cancer,
  however, is unknown.
• In the WHIMS ancillary studies of postmenopausal women 65 to 79 years
  of age, there was an increased risk of developing probable dementia in
  women receiving estrogen plus progestin when compared to placebo. It
  is unknown whether these findings apply to younger postmenopausal
  women.
• Estrogens increase the risk of gallbladder disease.
• Discontinue estrogen if severe hypercalcemia, loss of vision, severe
  hypertriglyceridemia, or cholestatic jaundice occurs.
• Monitor thyroid function in women on thyroid replacement hormone
  therapy.

Adverse Reactions

The most common adverse reactions (≥3%) for BIJUVA are breast tenderness
(10.4%), headache (3.4%), vaginal bleeding (3.4%), vaginal discharge
(3.4%), and pelvic pain (3.1%).

Please note that this information is not comprehensive. Please see
the Full Prescribing Information, including BOXED WARNING, for BIJUVA at https://www.bijuva.com/pi.pdf.

ANNOVERA IMPORTANT SAFETY INFORMATION

ANNOVERA is a progestin/estrogen combination hormonal contraceptive
(CHC) indicated for use by females of reproductive potential to prevent
pregnancy. (Limitation of use: Not adequately evaluated in females with
a BMI of > 29 kg/m²).

Due to increased risks of serious side effects, ANNOVERA should not be
used in females with certain medical conditions, including females who
have a high risk of arterial or venous thrombotic diseases; who have or
have had breast cancer or other estrogen- or progestin-sensitive cancer;
who have liver tumors, acute hepatitis, severe cirrhosis, undiagnosed
abnormal uterine bleeding, or hypersensitivity to any ingredients in
ANNOVERA; who use certain Hepatitis C drug combinations; or who are
pregnant or breastfeeding.

Risks from use of a CHC, like ANNOVERA, particularly in females with any
condition listed above, include venous thrombotic events; cardiovascular
events and cerebrovascular events such as stroke and myocardial
infarction; liver disease; elevated liver enzymes with concomitant
Hepatitis C treatment; hypertension; carbohydrate and lipid metabolic
effects; headache; bleeding irregularities and amenorrhea.

ANNOVERA does not protect against HIV-infection (AIDS) and other
sexually transmitted infections.

Please note that this information is not comprehensive. Please see
the Full Prescribing Information, including the Boxed Warning, for
ANNOVERA 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
agreement; 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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