TherapeuticsMD Announces Second Quarter 2016 Financial Results

– New Drug Application submitted for Yuvvexy™ (TX-004HR) –

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

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

Second Quarter and Recent Developments

  • Submitted a New Drug Application (NDA) with the U.S. Food and Drug
    Administration for Yuvvexy, the conditionally approved trade name for
    TX-004HR, the company’s 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 NDA is supported by the complete
    Yuvvexy clinical program, including positive results of the recently
    completed phase 3 Rejoice Trial. The submission included all three
    doses of Yuvvexy (4 mcg, 10 mcg and 25 mcg) that were evaluated in the
    Rejoice Trial.
  • Net revenue from the company’s prescription prenatal vitamin business
    was approximately $4.4 million for the second quarter of 2016,
    compared with approximately $4.8 million for the second quarter of
    2015.
  • Net loss was approximately $21.1 million for the second quarter of
    2016, compared with approximately $27.2 million for the second quarter
    of 2015.
  • Ended the quarter with approximately $166.5 million in cash and no
    debt.
  • 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. Approximately 1,642 patients have already
    exited the trial.
  • Presented posters on the positive results of the phase 3 Rejoice Trial
    for Yuvvexy at major medical conferences, including the Endocrine
    Society annual meeting (ENDO 2016) and the American College of
    Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific
    Meeting.
  • Launched innovative new compliance packaging for vitaMedMD’s
    vitaPearl™ prenatal multivitamin and BocaGreen’s Prena1 Pearl, the
    brand’s authorized generic.
  • Grew the company’s intellectual property portfolio to a current total
    of 135 patent filings, including 72 international filings, with 17
    issued U.S. patents.
  • Strengthened relationships with medical, pharmacy, patient and
    industry organizations worldwide, including ongoing activity with the
    leadership of the International Association of Compounding Pharmacists.

“The second quarter was transformative for our company, with the
submission of our NDA for Yuvvexy as a highly-differentiated potential
treatment for moderate to severe dyspareunia, a symptom of VVA, due to
menopause,” said TherapeuticsMD CEO Robert G. Finizio. “The Yuvvexy NDA
reflects a significant corporate achievement and we are thankful for the
contributions of everyone involved. As we prepare for future
commercialization of Yuvvexy, if approved, we also look forward to the
topline data in the fourth quarter of 2016 from our Replenish Trial for
TX-001HR, our second novel hormone therapy program. If approved, we
believe TX-001HR would be the first and only FDA-approved bio-identical
combination of estradiol and progesterone for treatment of
moderate-to-severe vasomotor symptoms due to menopause. We are very
pleased with our progress this year.”

Summary of Second Quarter 2016 Financial Results

For the quarter ended June 30, 2016, net revenue from the company’s
prescription prenatal vitamins was approximately $4.4 million compared
with net revenue of approximately $4.8 million for the prior year’s
quarter. The change in net revenue during the quarter was primarily
attributable to a decrease in the average net sales price of the
company’s products, partially offset by an increase in the number of
units sold.

Cost of goods sold was approximately $1.1 million for the three months
ended June 30, 2016, compared with approximately $1.0 million in the
prior year’s quarter.

Total operating expenses for the second quarter of 2016 included
research and development (R&D) expenses and sales, general and
administrative expenses (SG&A). R&D expenses during the second quarter
of 2016 were approximately $13.8 million compared to approximately $24.2
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 future
commercialization. SG&A expenses for the second quarter of 2016 were
approximately $10.6 million compared with approximately $6.9 million for
the prior year’s quarter, primarily due to the company’s investments in
human resources and sales and marketing to support future
commercialization.

Net loss for the second quarter of 2016 was approximately $21.1 million,
or $0.11 per basic and diluted share, compared with approximately $27.2
million, or $0.16 per basic and diluted share, for the second quarter of
2015.

At June 30, 2016, cash on hand was approximately $166.5 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, August 4, 2016

Time:

4:30 p.m. EDT

Telephone Access (US):

866-665-9531

Telephone Access (International):

724-987-6977

Access Code for All Callers:

88600937

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: 46530545.

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; whether the FDA will accept and, if
accepted, approve the company’s new drug application for its TX-004HR
product candidate; 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
   
June 30, 2016 December 31, 2015
(Unaudited)
 
ASSETS

Current Assets:

Cash $ 166,532,446 $ 64,706,355

Accounts receivable, net of allowance for doubtful accounts

of $529,298 and $81,910, respectively

4,477,308 3,049,715
Inventory 883,656 690,153
Other current assets   2,136,735   2,233,897
Total current assets   174,030,145   70,680,120
 
Fixed assets, net   444,412   198,592
 
Other Assets:
Intangible assets, net 1,983,829 1,615,251
Prepaid expense 1,109,883
Security deposit   129,864   125,000
Total other assets   2,113,693   2,850,134
Total assets $ 176,588,250 $ 73,728,846
 
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts payable $ 3,039,388 $ 3,126,174
Other current liabilities   6,299,783   7,539,526
Total current liabilities   9,339,171   10,665,700
Total liabilities   9,339,171   10,665,700
 
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 shares authorized;
196,492,195 and 177,928,041 issued and outstanding, respectively 196,492 177,928
Additional paid in capital 428,902,951 282,712,078
Accumulated deficit   (261,850,364)   (219,826,860)
Total stockholders’ equity   167,249,079   63,063,146
Total liabilities and stockholders’ equity $ 176,588,250 $ 73,728,846
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
       
Three Months Ended Six Months Ended
June 30, June 30,
2016 2015 2016 2015
 
Revenues, net $ 4,403,247 $ 4,847,934 $ 9,333,338 $ 9,322,983
 
Cost of goods sold   1,130,108   1,033,089   2,238,551   2,076,730
Gross profit   3,273,139   3,814,845   7,094,787   7,246,253
 
Operating expenses:
Sales, general, and administration 10,619,006 6,865,442 20,297,558 13,029,054
Research and development 13,841,193 24,190,714 28,938,210 42,367,549
Depreciation and amortization   24,262   14,280   43,859   27,852
Total operating expense   24,484,461   31,070,436   49,279,627   55,424,455
 
Operating loss   (21,211,322)   (27,255,591)   (42,184,840)   (48,178,202)
 
Other income:
Miscellaneous income 114,320 25,585 155,937 44,098
Accreted interest   2,863   2,560   5,399   12,402
Total other income   117,183   28,145   161,336   56,500
 
Loss before taxes (21,094,139) (27,227,446) (42,023,504) (48,121,702)
 
Provision for income taxes        
 
Net loss $ (21,094,139) $ (27,227,446) $ (42,023,504) $ (48,121,702)
 
Net loss per share, basic and diluted $ (0.11) $ (0.16) $ (0.21) $ (0.29)
 
Weighted average number of common
shares outstanding   196,325,715   172,782,264   195,613,639   168,734,760
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
   
Six Months Ended
June 30, 2016 June 30, 2015
 
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss $ (42,023,504) $ (48,121,702)
Adjustments to reconcile net loss to net cash flows used in
operating activities:
Depreciation of fixed assets 19,216 14,248
Amortization of intangible assets 24,643 13,604
Provision for doubtful accounts 447,388 30,767
Share-based compensation 9,200,844 2,968,811
Changes in operating assets and liabilities:
Accounts receivable (1,874,980) (1,190,068)
Inventory (193,503) (66,606)
Other current assets 1,001,120 383,194
Other assets (12,410)
Accounts payable (86,786) (508,511)
Deferred revenue (522,613)
Other current liabilities (1,239,743) 2,047,264
Other long-term liabilities     967,286
Net cash used in operating activities   (34,725,305)   (43,996,736)
 
CASH FLOWS FROM INVESTING ACTIVITIES
Patent costs (393,221) (78,792)
Purchase of fixed assets (265,036) (15,559)
Payment of security deposit   (4,864)  
Net cash used in investing activities   (663,121)   (94,351)
 
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from sale of common stock, net of costs 134,863,475 59,117,827
Proceeds from exercise of warrants 1,373,000 366,000
Proceeds from exercise of options   978,042   491,351
Net cash provided by financing activities   137,214,517   59,975,178
 
Increase in cash 101,826,091 15,884,091
Cash, beginning of period   64,706,355   51,361,607
Cash, end of period $ 166,532,446 $ 67,245,698

Contacts

TherapeuticsMD, Inc.
Investors:
David DeLucia, 561-961-1900
Director,
Investor Relations
David.DeLucia@TherapeuticsMD.com