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