TherapeuticsMD Announces Third Quarter 2015 Financial Results

Topline phase 3 data anticipated in fourth quarter for TX-004HR to
treat symptoms of VVA

Completed enrollment in phase 3 Replenish Trial for first potential
FDA-approved bio-identical oral combination hormone therapy

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 third quarter financial results for the
period ended September 30, 2015.

Recent and Third Quarter Developments

  • Revenues, net for the company’s prescription prenatal vitamin business
    increased to approximately $5.2 million for the third quarter of 2015
    compared with approximately $4.2 million for the third quarter of 2014.
  • Net loss was approximately $19.5 million for the third quarter of
    2015, compared with approximately $17.8 million for the third quarter
    of 2014, reflecting the costs of two phase 3 clinical trials for the
    company’s novel hormone therapy drug candidates.
  • Completed last patient visit in 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 pain during sexual
    intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy
    (VVA) due to menopause.
  • Completed patient enrollment 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.
  • Ended the quarter with approximately $81.1 million in cash and no debt.
  • Grew the company’s intellectual property portfolio to a current total
    of 111 patent filings, including 61 international filings, with two
    allowed and 13 issued U.S. patents.
  • Supported scientific abstracts and presentations at the annual meeting
    of the North American Menopause Society.
  • Continued to develop relationships with key medical, pharmacy, patient
    and industry organizations.

“As we pursue our mission to address women’s health needs, we believe
that there is a unique confluence of factors evolving on the scientific,
regulatory, legislative and commercial fronts that will help us to make
significant progress toward delivering on our vision and strategy,” said
TherapeuticsMD CEO Robert G. Finizio. “We continue to execute
both commercially and in R&D, including completion of enrollment in our
Replenish Trial of TX-001HR, our combination estradiol and progesterone
drug candidate for treatment of moderate to severe vasomotor symptoms
due to menopause. We also expect topline data from our Rejoice Trial of
TX-004HR for dyspareunia associated with VVA by the end of this year.
The market need for our products is large and growing, and we are
building key alliances with healthcare providers, women’s health
advocates and industry organizations.”

Third Quarter Financial Results Summary

Revenues, net for the third quarter of 2015 increased by 24 percent to
approximately $5.2 million compared with revenues, net of approximately
$4.2 million for the prior year’s quarter. Revenue growth during the
third quarter was primarily driven by increased number of units sold,
product mix, and average net sales price of the company’s prenatal
vitamin products.

Cost of goods sold increased to approximately $1.2 million for the three
months ended September 30, 2015, compared with approximately $1.1
million in the prior year’s quarter.

Total operating expenses for the third quarter of 2015 included research
and development (R&D) expenses and sales, general and administration
(SG&A). R&D expenses for the third quarter of 2015 were approximately
$16.4 million compared with approximately $14.9 million for the prior
year’s quarter. The increase in R&D expense was primarily due to an
increase in scale-up and manufacturing activities for the company’s
phase 3 drugs in development, which was partially offset by lower
clinical trial costs. SG&A expenses for the third quarter of 2015 were
approximately $7.0 million compared with approximately $6.0 million for
the third quarter of 2014, primarily as a result of increases in human
resources costs and professional fees, which were partially offset by a
decrease in marketing costs.

Non-operating income remained insignificant for the third quarter of
2015 and 2014 and included miscellaneous and interest income for both

Net loss for the third quarter of 2015 was approximately $19.5 million,
or $0.11 per basic and diluted share, compared with approximately $17.8
million, or $0.12 per basic and diluted share, for the third quarter of

At September 30, 2015, TherapeuticsMD had cash on hand of approximately
$81.1 million, compared with approximately $51.4 million at December 31,

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: Wednesday, November 4, 2015
Time: 4:30 p.m. EST
Access (US):
Telephone Access (International):
Access Code for All Callers: 61714687

Additionally, a live webcast can be accessed on the company’s website,,
on the “Home Page” or under the “Investor” section.

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:,,

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:

September 30, 2015 December 31, 2014
Current Assets:
Cash $ 81,123,988 $ 51,361,607
Accounts receivable, net of allowance for doubtful accounts
of $96,916 and $59,753, respectively 3,666,586 2,154,217
Inventory 870,059 1,182,113
Other current assets   2,120,805     1,537,407  
Total current assets 87,781,438 56,235,344
Fixed assets, net 56,748 63,293
Other Assets:
Prepaid expense 1,172,051 1,427,263
Intangible assets, net 1,324,284 1,228,588
Security deposit   125,000     125,000  
Total other assets   2,621,335     2,780,851  
Total assets $ 90,459,521   $ 59,079,488  
Current Liabilities:
Accounts payable $ 5,301,625 $ 6,327,129
Other current liabilities 6,386,777 3,840,639
Deferred revenue       522,613  
Total current liabilities 11,688,402 10,690,381
Long-Term Liabilities:
Accrued expenses   1,213,874      
Total liabilities   12,902,276     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; 177,787,927 and 156,097,019 issued and outstanding,
177,788 156,097
Additional paid-in capital 279,723,640 182,982,846
Accumulated deficit   (202,344,183 )   (134,749,836 )
Total stockholders’ equity   77,557,245     48,389,107  
Total liabilities and stockholders’ equity $ 90,459,521   $ 59,079,488  
Three Months Ended Nine Months Ended
September 30, September 30,
2015 2014 2015 2014
(Unaudited) (Unaudited) (Unaudited) (Unaudited)
Revenues, net $ 5,190,175 $ 4,186,261 $ 14,513,158 $ 10,768,572
Cost of goods sold   1,193,965     1,068,605     3,270,695     2,792,268  
Gross profit   3,996,210     3,117,656     11,242,463     7,976,304  
Operating expenses:
Sales, general, and administration 7,060,944 6,043,354 20,089,998 16,610,015
Research and development 16,421,753 14,909,430 58,789,302 29,052,149
Depreciation and amortization   16,548     12,747     44,400     39,909  
Total operating expenses   23,499,245     20,965,531     78,923,700     45,702,073  
Operating loss   (19,503,035 )   (17,847,875 )   (67,681,237 )   (37,725,769 )
Other income (expense):
Miscellaneous income 27,630 6,260 71,728 43,411
Interest income 2,760 9,364 15,162 27,756
Financing costs               (260,027 )
Total other income (expense)   30,390     15,624     86,890     (188,860 )
Loss before income taxes (19,472,645 ) (17,832,251 ) (67,594,347 ) (37,914,629 )
Provision for income taxes                
Net loss $ (19,472,645 ) $ (17,832,251 ) $ (67,594,347 ) $ (37,914,629 )
Loss per share, basic and diluted:
Net loss per share, basic and diluted $ (0.11 ) $ (0.12 ) $ (0.39 ) $ (0.26 )
Weighted average number of common
shares outstanding, basic and diluted   177,206,168     152,200,455     171,589,595     147,594,810  
Nine Months Ended
September 30, 2015 September 30, 2014
Net loss $ (67,594,347 ) $ (37,914,629 )
Adjustments to reconcile net loss to net cash used in
operating activities:
Depreciation 22,104 22,713
Amortization of intangible assets 22,296 17,196
Provision for doubtful accounts 37,163 2,594
Share-based compensation 4,740,906 3,934,836
Amortization of deferred financing costs 260,027
Changes in operating assets and liabilities:
Accounts receivable (1,549,532 ) (460,565 )
Inventory 312,054 31,673
Other current assets (621,923 ) 197,569
Other assets (15,162 ) (17,069 )
Accounts payable (1,025,504 ) 3,534,462
Deferred revenue (522,613 ) (754,431 )
Other current liabilities 2,546,138 909,890
Long term accrued expenses   1,213,874      
Net cash used in operating activities   (62,434,546 )   (30,235,734 )
Patent costs (117,992 ) (193,349 )
Purchase of property and equipment   (15,559 )   (30,962 )
Net cash used in investing activities   (133,551 )   (224,311 )
Proceeds from sale of common stock, net of costs 91,374,649 42,771,353
Proceeds from exercise of options 589,829 315,546
Proceeds from exercise of warrants   366,000     181,000  
Net cash provided by financing activities   92,330,478     43,267,899  
Increase in cash 29,762,381 12,807,854
Cash, beginning of period   51,361,607     54,191,260  
Cash, end of period $ 81,123,988   $ 66,999,114  


TherapeuticsMD, Inc.
Dan Cartwright, 561-961-1900
Financial Officer