TherapeuticsMD Announces Third Quarter 2016 Financial Results

– Topline phase 3 data for TX-001HR Replenish Trial on track for
fourth quarter of 2016 –

– TX-004HR PDUFA target action date of May 7, 2017 –

BOCA RATON, Fla.–(BUSINESS WIRE)–TherapeuticsMD, Inc. (NYSE MKT:TXMD), an innovative women’s healthcare
company, today announced its third quarter financial results for the
quarter ended September 30, 2016.

Third Quarter and Recent Developments

• Announced acceptance of a New Drug Application (NDA) by the U.S. Food
  and Drug Administration (FDA) for TX-004HR (conditionally-approved
  trade name Yuvvexy™), the company’s investigational applicator-free
  estradiol vaginal softgel capsule 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 NDA is supported by the complete TX-004HR clinical
  program, including positive phase 3 results with all three doses of
  TX-004HR (4 mcg, 10 mcg and 25 mcg) that were evaluated in the Rejoice
  Trial. The FDA’s Prescription Drug User Fee Act (PDUFA) target action
  date for the NDA is May 7, 2017.
• Anticipate topline results in the fourth quarter of 2016 for the
  ongoing Replenish Trial, a phase 3 clinical trial of the company’s
  TX-001HR product candidate, which, if approved, would be the first and
  only FDA-approved bio-identical combination of estradiol and
  progesterone for the treatment of moderate-to-severe vasomotor
  symptoms due to menopause.
• Net revenue from the company’s prescription prenatal vitamin business
  increased 7 percent to approximately $5.5 million for the third
  quarter of 2016, compared with approximately $5.2 million for the
  third quarter of 2015.
• Net loss was approximately $25.0 million for the third quarter of
  2016, compared with approximately $19.5 million for the third quarter
  of 2015.
• Ended the quarter with approximately $147.5 million in cash and no
  debt.
• Supported nine presentations at annual meetings of the International
  Menopause Society (IMS) and North American Menopause Society (NAMS),
  including reports on the positive results from the TX-004HR clinical
  development program and new data that further identify women’s
  perceptions of VVA and available treatment options.
• Grew the company’s intellectual property portfolio to a current total
  of 149 patent filings, including 82 international filings, with 17
  issued U.S. patents.
• Strengthened relationships with medical, pharmacy, patient and
  industry organizations internationally.

“We are making excellent progress this year advancing our pipeline and
enhancing our commercial capabilities focused on women’s health. During
the quarter, we successfully completed the submission of our NDA for
TX-004HR as a novel treatment for moderate to severe dyspareunia, a
symptom of VVA due to menopause, and we continued ongoing
pre-commercialization activities for this important product,” said
TherapeuticsMD CEO Robert G. Finizio. “We now eagerly await the topline
data from our Replenish Trial for TX-001HR in the fourth quarter of
2016, our second novel hormone therapy program, which, if approved,
would be the first and only FDA-approved bio-identical combination of
estradiol and progesterone for the treatment of moderate-to-severe
vasomotor symptoms due to menopause.”

Summary of Third Quarter 2016 Financial Results

Net revenue from the company’s prescription prenatal vitamins increased
7 percent to approximately $5.5 million for the third quarter of 2016
from approximately $5.2 million for the prior year’s quarter.

Cost of goods sold was approximately $1.2 million for the third quarter
of both 2016 and 2015.

Total operating expenses for the third quarter of 2016 included research
and development (R&D) expenses and sales, general and administrative
expenses (SG&A). R&D expenses during the third quarter of 2016 were
approximately $14.7 million compared to approximately $16.4 million
during the prior year’s quarter, reflecting a decline in the company’s
clinical trial costs. SG&A expenses for the third quarter of 2016 were
approximately $14.7 million compared with approximately $7.1 million for
the prior year’s quarter. Higher SG&A expenses during the third quarter
of 2016 were primarily due to an increase in the company’s sales,
marketing and regulatory personnel to support future commercialization
of the company’s pipeline products.

Net loss for the third quarter of 2016 was approximately $25.0 million,
or $0.13 per basic and diluted share, compared with approximately $19.5
million, or $0.11 per basic and diluted share, for the third quarter of
2015.

At September 30, 2016, cash on hand was approximately $147.5 million,
compared with approximately $64.7 million at December 31, 2015.

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, November 3, 2016

Time:

4:30 p.m. EDT

Telephone Access (US):

866-665-9531

Telephone Access (International):

724-987-6977

Access Code for All Callers:

99198056

Additionally, a live webcast can be accessed on the company’s website, www.therapeuticsmd.com,
in 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: 99198056.

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.

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 its hormone therapy drug candidates and obtain additional
financing necessary therefor; whether the FDA will approve the company’s
new drug application for its TX-004HR product candidate and whether any
such approval will occur by the PDUFA date; 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
			September 30, 2016				December 31, 2015
			(Unaudited)
ASSETS
Current Assets:
	Cash		$	147,534,065			$	64,706,355
	Accounts receivable, net of allowance for doubtful accounts
	of $113,034 and $81,910, respectively			5,033,298				3,049,715
	Inventory			843,398				690,153
	Other current assets			2,693,475				2,233,897
	Total current assets			156,104,236				70,680,120
Fixed assets, net				460,546				198,592
Other Assets:
	Intangible assets, net			2,118,378				1,615,251
	Prepaid expense			–				1,109,883
	Security deposit			139,036				125,000
	Total other assets			2,257,414				2,850,134
	Total assets		$	158,822,196			$	73,728,846
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
	Accounts payable		$	4,224,419			$	3,126,174
	Other current liabilities			8,243,421				7,539,526
	Total current liabilities			12,467,840				10,665,700
	Total liabilities			12,467,840				10,665,700
Commitments and Contingencies – See Note 15
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 shares authorized;
	196,580,212 and 177,928,041 issued and outstanding, respectively			196,580				177,928
	Additional paid in capital			433,023,801				282,712,078
	Accumulated deficit			(286,866,025	)			(219,826,860	)
	Total stockholders’ equity			146,354,356				63,063,146
	Total liabilities and stockholders’ equity		$	158,822,196			$	73,728,846

THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
			Three Months Ended														Nine Months Ended
			September 30,														September 30,
				2016				2015										2016				2015
Revenues, net			$	5,535,685			$	5,190,175									$	14,869,023			$	14,513,158
Cost of goods sold				1,237,446				1,193,965										3,475,997				3,270,695
Gross profit				4,298,239				3,996,210										11,393,026				11,242,463
Operating expenses:
	Sales, general, and administration			14,721,710				7,060,944										35,019,268				20,089,998
	Research and development			14,664,123				16,421,753										43,602,333				58,789,302
	Depreciation and amortization			40,460				16,548										84,319				44,400
	Total operating expense			29,426,293				23,499,245										78,705,920				78,923,700
Operating loss				(25,128,054	)			(19,503,035	)									(67,312,894	)			(67,681,237	)
Other income:
	Miscellaneous income			109,942				27,630										265,879				71,728
	Accreted interest			2,451				2,760										7,850				15,162
	Total other income			112,393				30,390										273,729				86,890
Loss before taxes				(25,015,661	)			(19,472,645	)									(67,039,165	)			(67,594,347	)
Provision for income taxes				–				–										–				–
Net loss			$	(25,015,661	)		$	(19,472,645	)								$	(67,039,165	)		$	(67,594,347	)
Net loss per share, basic and diluted			$	(0.13	)		$	(0.11	)								$	(0.34	)		$	(0.39	)
Weighted average number of common
	shares outstanding			196,502,327				177,206,168										195,912,173				171,589,595

THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
			Nine Months Ended
			September 30, 2016				September 30, 2015
CASH FLOWS FROM OPERATING ACTIVITIES
	Net loss		$	(67,039,165	)		$	(67,594,347	)
	Adjustments to reconcile net loss to net cash flows used in
	operating activities:
	Depreciation of fixed assets			45,759				22,104
	Amortization of intangible assets			38,560				22,296
	Provision for doubtful accounts			2,261,568				37,163
	Share-based compensation			13,385,215				4,740,906
	Changes in operating assets and liabilities:
	Accounts receivable			(4,245,151	)			(1,549,532	)
	Inventory			(153,245	)			312,054
	Other current assets			379,930				(621,923	)
	Other assets			–				(15,162	)
	Accounts payable			1,098,245				(1,025,504	)
	Deferred revenue			–				(522,613	)
	Other current liabilities			703,895				2,546,138
	Other long-term liabilities			–				1,213,874
	Net cash used in operating activities			(53,524,389	)			(62,434,546	)
CASH FLOWS FROM INVESTING ACTIVITIES
	Patent costs			(541,686	)			(117,992	)
	Purchase of fixed assets			(307,714	)			(15,559	)
	Payment of security deposit			(14,036	)			–
	Net cash used in investing activities			(863,436	)			(133,551	)
CASH FLOWS FROM FINANCING ACTIVITIES
	Proceeds from sale of common stock, net of costs			134,863,475				91,374,649
	Proceeds from exercise of warrants			1,373,000				366,000
	Proceeds from exercise of options			979,060				589,829
	Net cash provided by financing activities			137,215,535				92,330,478
	Increase in cash			82,827,710				29,762,381
	Cash, beginning of period			64,706,355				51,361,607
	Cash, end of period		$	147,534,065			$	81,123,988

Contacts

TherapeuticsMD, Inc.
Investor Contact:
David
DeLucia, 561-961-1900
Director, Investor Relations
David.DeLucia@TherapeuticsMD.com
or
Media
Contact:
SparkBioComm
Ami Knoefler, 650-739-9952
Ami@SparkBiocomm.com