TherapeuticsMD Announces Fourth Quarter and Full Year 2015 Financial Results

– Company to Present additional positive phase 3 data for TX-004HR at
the ISSWSH annual meeting –

– Management to host conference call today at 4:30 p.m. EST –

BOCA RATON, Fla.–(BUSINESS WIRE)–TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare
company, today announced its fourth quarter and full year financial
results for 2015.

2015 and Recent Developments

• Net revenue for the company’s prescription prenatal vitamin business
  increased to approximately $20.1 million in 2015 compared with
  approximately $15.0 million for the prior year.
• Net loss was approximately $85.1 million in 2015, compared with
  approximately $54.2 million for the prior year, reflecting investment
  in two phase 3 clinical trials for the company’s novel hormone therapy
  drug candidates.
• Reported positive topline data from the Rejoice Trial, a phase 3
  clinical trial of TX-004HR, an applicator-free vaginal estradiol
  softgel drug candidate for the treatment of moderate to severe vaginal
  pain during sexual intercourse (dyspareunia), a symptom of vulvar and
  vaginal atrophy (VVA) due to menopause. The results showed patients
  treated with TX-004HR achieved a statistically significant improvement
  over placebo across all four co-primary endpoints at all three doses
  evaluated. The validated co-primary endpoint data and additional
  secondary endpoint results related to vaginal dryness are scheduled to
  be presented this week at the International Society for the Study of
  Women’s Sexual Health (ISSWSH) Annual Meeting 2016. A summary of these
  data is included below in this press release.
• Exited over 1,400 of the 1,750 patients enrolled in the Replenish
  Trial, a phase 3 clinical trial of TX-001HR, a combination estradiol
  and progesterone drug candidate, for the treatment of moderate to
  severe vasomotor symptoms due to menopause. Topline results are
  currently anticipated late in the fourth quarter of 2016.
• The company’s intellectual property portfolio grew to a current total
  of 122 patent filings, including 72 international filings, with one
  allowed and 14 issued U.S. patents.
• Presented two posters at North American Menopause Society (NAMS) of
  the company’s transdermal progesterone candidate, TX-005HR, and the
  company’s transdermal estradiol and progesterone candidate, TX-006HR,
  demonstrating tissue penetration and target organ activity in a
  preclinical study.
• Strengthened relationships with key medical, pharmacy, patient and
  industry organizations worldwide.
• Ended the year with approximately $64.7 million in cash and no debt,
  which was further strengthened by an equity offering in January 2016
  that generated approximately $135 million of net proceeds to fund
  commercialization activities for both of the company’s late stage
  product candidates and other development activities.

“2015 was a breakthrough year for our company, as we reported positive
topline phase 3 data from the Rejoice Trial for TX-004HR, the first of
our two novel pipeline candidates in the women’s health arena,” said
TherapeuticsMD CEO Robert G. Finizio. “Based on those compelling
results, we are preparing to file an NDA before June 30, while we also
expect topline data late in the fourth quarter of 2016 from our
Replenish Trial for TX-001HR. We believe we are well positioned from a
financial, clinical and commercial standpoint to execute on our goals in
2016 and create significant value for shareholders by advancing our
pipeline and preparing to launch our first novel hormone product for
women, if approved.”

Summary of 2015 Financial Results

For the year ended December 31, 2015, net revenue increased
approximately 34 percent to approximately $20.1 million compared with
approximately $15.0 million for the prior year. Net revenue for the
fourth quarter of 2015 was approximately $5.6 million compared with net
revenue of approximately $4.3 million for the prior year’s quarter.
Revenue growth during the fourth quarter was primarily driven by a
change in product mix and an increase in the average net sales price of
the company’s prenatal vitamin products and revenue growth during the
full year was primarily driven by an increase in the number of units
sold and an increase in the average sales price of the company’s
prenatal vitamin products.

Cost of goods sold increased to approximately $4.5 million for the full
year 2015, compared with approximately $3.7 million in the prior year.

Total operating expenses for the fourth quarter and full year 2015
included research and development (R&D) expenses and sales, general and
administrative expenses (SG&A). R&D expenses for the full-year 2015 were
approximately $72.0 million compared with approximately $43.2 million
for the prior year, primarily as a result of an increase in costs
related to the company’s phase 3 clinical trials for TX-001HR and
TX-004HR and an increase in scale-up and manufacturing activities
primarily related to TX-001HR. R&D expenses during the fourth quarter of
2015 were $13.3 million compared to $14.2 million during the prior
year’s quarter, reflecting a significant decline in the company’s
clinical trial costs, partially offset by an increase in scale-up and
manufacturing activities to support commercialization. SG&A expenses for
the full-year 2015 were approximately $28.7 million compared with
approximately $22.1 million for the prior year, reflecting an increase
in human resources related costs, increased consulting and professional
costs, increased insurance cost and increased sales and marketing
expenses. SG&A expenses for the fourth quarter of 2015 were
approximately $8.6 million compared with approximately $5.5 million for
the prior year’s quarter, primarily as a result of increased human
resource related costs, as well as increased sales and marketing and
office expenses.

Non-operating income remained insignificant for the full year 2015 and
2014 and included interest income and other miscellaneous items of
income and expense for both periods.

Net loss for the full year 2015 was approximately $85.1 million, or
$0.49 per basic and diluted share, compared with approximately $54.2
million, or $0.36 per basic and diluted share, for the full year 2014.
Net loss in the fourth quarter of 2015 was approximately $17.5 million,
or $0.10 per basic and diluted share, compared with approximately $16.3
million, or $0.10 per basic and diluted share, for the fourth quarter of
2014.

At December 31, 2015, cash on hand was approximately $64.7 million,
compared with approximately $51.4 million at December 31, 2014.

Phase 3 Data Results Presented at ISSWSH Annual Meeting 2016

TherapeuticsMD also announced that data from the phase 3 Rejoice Trial
would be presented at the ISSWSH Annual Meeting 2016 taking place
February 25-28 in Charleston, South Carolina. The poster to be presented
includes validated co-primary endpoint results from the Rejoice Trial
and secondary endpoint data that demonstrate the effect of TX-004HR on
severity of vaginal dryness as compared with placebo at week 12.

Based on the company’s ongoing analyses of the Rejoice Trial data,
statistical significance of the results for the co-primary endpoint of
severity of participants’ self-reported moderate to severe dyspareunia
as the most bothersome symptom of VVA has slightly improved for all
three doses from the topline results previously reported. The secondary
endpoint result for vaginal dryness was also statistically significant
for all three doses evaluated in the Rejoice Trial.

Statistical Significance of Results for Co-Primary Endpoints
(Based on LS Mean Change from Baseline to Week 12 Compared to Placebo)
		25 mcg		10 mcg		4 mcg
Superficial Cells		P < 0.0001		P < 0.0001		P < 0.0001
Parabasal cells		P < 0.0001		P < 0.0001		P < 0.0001
Vaginal pH		P < 0.0001		P < 0.0001		P < 0.0001
Severity of Dyspareunia		P < 0.0001		P < 0.0001		P = 0.0149
Statistical Significance of Results for Secondary Endpoint of Severity of Vaginal Dryness (Based on LS Mean Change from Baseline to Week 12 Compared to Placebo)
Severity of Dryness		P < 0.0001		P < 0.0001		P = 0.0014
LS= Least Squares

Conference Call Today

As previously announced, TherapeuticsMD will host a conference call
today to discuss these financial results and provide a business update.
Details for the call are:

Date:		Thursday, February 25, 2016
Time:		4:30 p.m. EST
Telephone Access (US):		866-665-9531
Telephone Access (International):		724-987-6977
Access Code for All Callers:		45870409

Additionally, a live webcast can be accessed on the company’s website, www.therapeuticsmd.com,
on the Home Page or under the “Investors & Media” section. 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: 45870409.

About TherapeuticsMD, Inc.

TherapeuticsMD, Inc. is an innovative healthcare company focused on
developing and commercializing products exclusively for women. With its
SYMBODA™ technology, TherapeuticsMD is developing advanced hormone
therapy pharmaceutical products to enable delivery of bio-identical
hormones through a variety of dosage forms and administration routes.
The company’s clinical development pipeline includes two phase 3
products. The company also manufactures and distributes branded and
generic prescription prenatal vitamins as well as over-the-counter
vitamins under the vitaMedMD^® and BocaGreenMD^®
brands. More information is available at the following websites: www.therapeuticsmd.com,
www.vitamedmd.com,
www.vitamedmdrx.com
and www.bocagreenmd.com.

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 its hormone therapy drug candidates and obtain additional
financing necessary therefor; the length, cost and uncertain results of
the company’s clinical trials; the potential of adverse side effects or
other safety risks that could preclude the approval of the company’s
hormone therapy drug candidates; the company’s reliance on third parties
to conduct its clinical trials, research and development and
manufacturing; 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.

THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
			December 31,
			2015				2014
ASSETS
Current Assets:
	Cash		$	64,706,355			$	51,361,607
	Accounts receivable, net of allowance for doubtful accounts
	of $81,910 and $59,753, respectively			3,049,715				2,154,217
	Inventory			690,153				1,182,113
	Other current assets			2,233,897				1,537,407
	Total current assets			70,680,120				56,235,344
Fixed assets, net				198,592				63,293
Other Assets:
	Intangible assets, net			1,615,251				1,228,588
	Prepaid expense			1,109,883				1,427,263
	Security deposit			125,000				125,000
	Total other assets			2,850,134				2,780,851
	Total assets		$	73,728,846			$	59,079,488
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
	Accounts payable		$	3,126,174			$	6,327,129
	Other current liabilities			7,539,526				3,840,639
	Deferred revenue			–				522,613
	Total current liabilities			10,665,700				10,690,381
Commitments and Contingencies
Stockholders’ Equity:
	Preferred stock – par value $0.001; 10,000,000 shares authorized;
	no shares issued and outstanding			–				–
	Common stock – par value $0.001; 350,000,000 and 250,000,000
	shares authorized; 177,928,041 and 156,097,019 issued
	and outstanding, respectively			177,928				156,097
	Additional paid-in capital			282,712,078				182,982,846
	Accumulated deficit			(219,826,860	)			(134,749,836	)
	Total stockholders’ equity			63,063,146				48,389,107
	Total liabilities and stockholders’ equity		$	73,728,846			$	59,079,488

THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
			Three Months Ended December 31,								Year Ended December 31,
			2015				2014				2015				2014				2013
Revenues, net			$	5,629,740			$	4,257,647			$	20,142,898			$	15,026,219			$	8,775,598
Cost of goods sold				1,235,978				879,535				4,506,673				3,671,803				1,959,597
Gross profit				4,393,762				3,378,112				15,636,225				11,354,416				6,816,001
Operating expenses:
	Sales, general, and administrative			8,631,238				5,514,057				28,721,236				22,124,072				19,014,837
	Research and development			13,253,472				14,166,789				72,042,774				43,218,938				13,551,263
	Depreciation and amortization			18,000				12,558				62,400				52,467				58,145
	Total operating expenses			21,902,710				19,693,404				100,826,410				65,395,477				32,624,245
Operating loss				(17,508,948	)			(16,315,292	)			(85,190,185	)			(54,041,061	)			(25,808,244	)
Other income and (expenses)
	Miscellaneous income, net			23,991				3,158				95,719				46,569				34,544
	Interest income			2,280				9,553				17,442				37,309				27,234
	Financing costs			–				–				–				(260,027	)			(1,503,922	)
	Interest expense			–				–				–				–				(1,165,981	)
	Loan guaranty costs			–				–				–				–				(2,944	)
	Total other income (expense)			26,271				12,711				113,161				(176,149	)			(2,611,069	)
Loss before income taxes				(17,482,677	)			(16,302,581	)			(85,077,024	)			(54,217,210	)			(28,419,313	)
Provision for income taxes				–				–				–				–				–
Net loss			$	(17,482,677	)		$	(16,302,581	)		$	(85,077,024	)		$	(54,217,210	)		$	(28,419,313	)
Loss per share, basic and diluted:
Net loss per share, basic and diluted			$	(0.10	)		$	(0.10	)		$	(0.49	)		$	(0.36	)		$	(0.22	)
Weighted average number of common
	shares outstanding, basic and diluted			177,876,462				156,054,938				173,174,229				149,727,228				127,569,731

THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
			Year Ended December, 31,
			2015				2014				2013
CASH FLOWS FROM OPERATING ACTIVITIES
	Net loss		$	(85,077,024	)		$	(54,217,210	)		$	(28,419,313	)
	Adjustments to reconcile net loss to net cash used in
	operating activities:
	Depreciation			29,959				28,987				47,883
	Amortization of intangible assets			32,441				23,480				10,262
	Provision for (recovery of) doubtful accounts			22,157				(5,436	)			(15,493	)
	Amortization of debt discount			–				–				1,102,680
	Share-based compensation			7,189,699				4,970,312				3,844,155
	Amortization of deferred financing costs			–				260,027				1,451,934
	Loan guaranty costs			–				–				2,944
	Changes in operating assets and liabilities:
	Accounts receivable			(917,656	)			(458,028	)			(1,068,619	)
	Inventory			491,960				(138,495	)			571,592
	Other current assets			(773,532	)			680,281				(1,386,319	)
	Other assets			(17,442	)			(37,309	)			(565,706	)
	Accounts payable			(3,200,955	)			4,212,912				472,851
	Deferred revenue			(522,613	)			(1,079,967	)			457,828
	Other current liabilities			3,698,887				239,450				2,875,320
	Other liabilities			–				–				(150,068	)
	Net cash used in operating activities			(79,044,119	)			(45,520,996	)			(20,768,069	)
CASH FLOWS FROM INVESTING ACTIVITIES
	Patent costs			(419,104	)			(586,480	)			(439,034	)
	Purchase of fixed assets			(165,257	)			(30,962	)			(40,790	)
	Refund (payment) of security deposit			–				10,686				(103,737	)
	Net cash used in investing activities			(584,361	)			(606,756	)			(583,561	)
CASH FLOWS FROM FINANCING ACTIVITIES
	Proceeds from sale of common stock, net of costs			91,374,649				42,771,353				78,650,353
	Proceeds from exercise of options			1,232,579				345,746				30,910
	Proceeds from exercise of warrants			366,000				181,000				–
	Proceeds bank line of credit			–				–				500,000
	Repayment of bank line of credit			–				–				(500,000	)
	Repayment of notes payable			–				–				(4,691,847	)
	Net cash provided by financing activities			92,973,228				43,298,099				73,989,416
	Increase (decrease) in cash			13,344,748				(2,829,653	)			52,637,786
	Cash, beginning of period			51,361,607				54,191,260				1,553,474
	Cash, end of period		$	64,706,355			$	51,361,607			$	54,191,260
	SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:
	Cash paid for interest		$	–			$	–			$	212,853
	Cash paid for income taxes		$	–			$	–			$	–
	SUPPLEMENTAL SCHEDULE OF NON-CASH FINANCING ACTIVITIES:
	Warrants issued for financing		$	–			$	–			$	1,711,956
	Warrants issued for services		$	–			$	–			$	462,196

Contacts

TherapeuticsMD, Inc.
Investors:
Dan Cartwright, 561-961-1900
Chief
Financial Officer
Dan.Cartwright@TherapeuticsMD.com