TherapeuticsMD Announces Fourth Quarter and Full-Year 2016 Financial Results

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– Pipeline of two late-stage product candidates advancing towards
commercialization, with launch of TX-004HR expected in fourth quarter
2017 pending regulatory approval –

– Management to host conference call today at 8:00 a.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 2016.

2016 and Recent Developments

  • Net revenue for the company’s prescription prenatal vitamin business
    was approximately $19.4 million in 2016 compared with approximately
    $20.1 million for the prior year.
  • Net loss was approximately $89.9 million in 2016, compared with
    approximately $85.1 million for the prior year, reflecting investment
    in clinical development for the company’s two phase 3 hormone therapy
    drug candidates.
  • Ended the year with approximately $131.5 million in cash and no debt.
  • Reported positive topline data from the Replenish Trial, a
    phase 3 clinical trial of TX-001HR, the company’s bio-identical
    hormone therapy combination of estradiol and progesterone in a single,
    oral softgel, for the treatment of moderate-to-severe vasomotor
    symptoms due to menopause. Topline results from the trial in 1,835
    post-menopausal women demonstrated that multiple doses of TX-001HR
    resulted in a statistically significant reduction from baseline
    in both the frequency and severity of hot flashes compared to placebo.
    In addition, endometrial safety was established with an incidence rate
    of endometrial hyperplasia or malignancy of 0% across all doses. The
    company plans to submit a New Drug Application (NDA) for TX-001HR to
    the U.S. Food and Drug Administration (FDA) in the third quarter of
    2017.
  • Submitted an NDA for TX-004HR, the company’s applicator-free estradiol
    vaginal softgel capsule 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 TX-004HR clinical
    program, including positive results from all three doses of TX-004HR
    (4 mcg, 10 mcg and 25 mcg) that were evaluated in the phase 3 Rejoice
    Trial. The FDA’s Prescription Drug User Fee Act (PDUFA) target action
    date for the NDA is May 7, 2017.
  • Published three manuscripts with detailed results of the TX-004HR
    phase 3 Rejoice Trial in the peer-reviewed journal Menopause.
    The manuscripts review the positive results of TX-004HR across
    pre-specified co-primary and secondary endpoints in the Rejoice Trial,
    data from a pharmacokinetic (PK) substudy demonstrating the low
    systemic absorption of TX-004HR, as well as data from a patient
    acceptability and satisfaction survey demonstrating a high level of
    product acceptability, ease of use, and patient satisfaction with
    TX-004HR.
  • The company’s intellectual property portfolio grew to a current total
    of 144 patent filings, including 74 international filings, with one
    allowed and 17 issued U.S. patents.
  • Strengthened relationships with key medical, pharmacy, patient and
    industry organizations worldwide. This includes the recent launch of
    the company’s BIO-IGNITE™ program, an outreach program to quantify the
    number of compounded bio-identical estradiol and progesterone
    prescriptions currently dispensed by the 3,000-3,500 high-volume
    compounding pharmacies and qualify their interests in distributing the
    company’s bio-identical hormone product candidates, if approved.

“During 2016, we made significant advancements with our two late-stage
pipeline candidates while we pursued our goal to bring new healthcare
solutions to women to help manage their menopause symptoms,” said
TherapeuticsMD CEO Robert G. Finizio. “As we look forward to 2017, we
are planning the launch of TX-004HR, pending regulatory approval, as a
highly differentiated new treatment for moderate-to-severe dyspareunia,
a symptom of VVA due to menopause. We also intend to file an NDA for
TX-001HR, 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 2016 Financial Results

For the year ended December 31, 2016, net revenue was approximately
$19.4 million compared with approximately $20.1 million for the prior
year. Net revenue for the fourth quarter of 2016 was approximately $4.5
million compared with net revenue of approximately $5.6 million for the
prior year’s quarter. These changes were primarily due to a decrease in
the average net sales price of our products, partially offset by an
increase in the number of units sold.

Total operating expenses for the fourth quarter and full-year 2016
included research and development (R&D) expenses and sales, general and
administrative expenses (SG&A). R&D expenses for the full-year 2016 were
approximately $53.9 million compared with approximately $72.0 million
for the prior year. R&D expenses for the fourth quarter of 2016 were
approximately $10.3 million compared to approximately $13.3 million
during the prior year’s quarter. The decreases in R&D were primarily due
to lower clinical trial costs as the company completed its phase 3
clinical trials for TX-001HR and TX-004HR. SG&A expenses for the
full-year 2016 were approximately $51.3 million compared with
approximately $28.7 million for the prior year. SG&A expenses for the
fourth quarter of 2016 were approximately $16.3 million compared with
approximately $8.6 million for the prior year’s quarter. The increases
in SG&A were primarily due to higher sales, marketing, regulatory
expenditures, and personnel costs to support future commercialization.

Net loss for the full-year 2016 was approximately $89.9 million, or
$0.46 per basic and diluted share, compared with approximately $85.1
million, or $0.49 per basic and diluted share, for the full-year 2015.
Net loss in the fourth quarter of 2016 was approximately $22.8 million,
or $0.12 per basic and diluted share, compared with approximately $17.5
million, or $0.10 per basic and diluted share, for the fourth quarter of
2015.

At December 31, 2016, cash on hand was approximately $131.5 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, February 23, 2017

Time:

8:00 a.m. EST

Telephone Access (US):

866-665-9531

Telephone Access (International):

724-987-6977

Access Code for All Callers:

68412683
 

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: 68412683.

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 late stage clinical pipeline includes two phase 3 product
candidates: TX-001HR for treatment of moderate-to-severe vasomotor
symptoms (VMS) due to menopause and TX-004HR for treatment of
moderate-to-severe vaginal pain during sexual intercourse (dyspareunia),
a symptom of vulvar and vaginal atrophy (VVA) due to menopause. The
company also manufactures and distributes branded and generic
prescription prenatal vitamins as well as over-the-counter prenatal
vitamins under the vitaMedMD® and BocaGreenMD®
brands.

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 company will be able to
prepare a new drug application for its TX-001HR product candidate and,
if prepared, whether the FDA will accept and approve the application;
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
 
December 31,
  2016     2015  
ASSETS
Current Assets:
Cash $ 131,534,101 $ 64,706,355
Accounts receivable, net of allowance for doubtful accounts
of $376,374 and $81,910, respectively 4,500,699 3,049,715
Inventory 1,076,321 690,153
Other current assets   2,299,052     2,233,897  
Total current assets   139,410,173     70,680,120  
 
Fixed assets, net   516,839     198,592  
 
Other Assets:
Intangible assets, net 2,405,972 1,615,251
Security deposit 139,036 125,000
Prepaid expense       1,109,883  
Total other assets   2,545,008     2,850,134  
Total assets $ 142,472,020   $ 73,728,846  
 
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts payable $ 7,358,514 $ 3,126,174
Other current liabilities   7,624,085     7,539,526  
Total current liabilities   14,982,599     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:
196,688,222 and 177,928,041 issued and outstanding, respectively 196,688 177,928
Additional paid-in capital 436,995,052 282,712,078
Accumulated deficit   (309,702,319 )   (219,826,860 )
Total stockholders’ equity   127,489,421     63,063,146  
Total liabilities and stockholders’ equity $ 142,472,020   $ 73,728,846  
 
         
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
 

 

Three Months Ended December 31,

Year Ended December 31,

  2016     2015     2016     2015     2014  
 
 
Revenues, net $ 4,487,427 $ 5,629,740 $ 19,356,450 $ 20,142,898 $ 15,026,219
 
Cost of goods sold   709,711     1,235,978     4,185,708     4,506,673     3,671,803  
 
Gross profit   3,777,716     4,393,762     15,170,742     15,636,225     11,354,416  
 
Operating expenses:
Sales, general, and administrative 16,329,146 8,631,238 51,348,414 28,721,236 22,124,072
Research and development 10,341,144 13,253,472 53,943,477 72,042,774 43,218,938
Depreciation and amortization 48,132 18,000 132,451 62,400 52,467
         
Total operating expenses   26,718,422     21,902,710     105,424,342     100,826,410     65,395,477  
 
Operating loss   (22,940,706 )   (17,508,948 )   (90,253,600 )   (85,190,185 )   (54,041,061 )
 
Other income and (expense)
Miscellaneous income 101,438 23,991 367,317 95,719 46,569
Accreted interest 2,974 2,280 10,824 17,442 37,309
Financing costs (260,027 )
         
Total other income (expense)   104,412     26,271     378,141     113,161     (176,149 )
 
Loss before income taxes (22,836,294 ) (17,482,677 ) (89,875,459 ) (85,077,024 ) (54,217,210 )
 
Provision for income taxes                    
 
Net loss $ (22,836,294 ) $ (17,482,677 ) $ (89,875,459 ) $ (85,077,024 ) $ (54,217,210 )
 
Loss per share, basic and diluted:
 
Net loss per share, basic and diluted $ (0.12 ) $ (0.10 ) $ (0.46 ) $ (0.49 ) $ (0.36 )
 
Weighted average number of common
shares outstanding, basic and diluted   196,613,297     177,876,462     196,088,196     173,174,229     149,727,228  
 
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
       
 
Year Ended December, 31,
  2016     2015     2014  
 
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss $ (89,875,459 ) $ (85,077,024 ) $ (54,217,210 )
Adjustments to reconcile net loss to net cash used in
operating activities:
Depreciation 77,906 29,959 28,987
Amortization of intangible assets 54,545 32,441 23,480
Provision for (recovery of) doubtful accounts 2,524,909 22,157 (5,436 )
Share-based compensation 17,411,021 7,189,699 4,970,312
Amortization of deferred financing costs 260,027
Changes in operating assets and liabilities:
Accounts receivable (3,975,893 ) (917,656 ) (458,028 )
Inventory (386,168 ) 491,960 (138,495 )
Other current assets 709,907 (773,532 ) 680,281
Other assets (17,442 ) (37,309 )
Accounts payable 4,232,340 (3,200,955 ) 4,212,912
Deferred revenue (522,613 ) (1,079,967 )
Other current liabilities 84,559 3,698,887 239,450
     
 
Net cash used in operating activities   (69,142,333 )   (79,044,119 )   (45,520,996 )
 
CASH FLOWS FROM INVESTING ACTIVITIES
Patent costs (845,266 ) (419,104 ) (586,480 )
Purchase of fixed assets (396,154 ) (165,257 ) (30,962 )

(Payment) refund of security deposit

(14,036 ) 10,686
     
 
Net cash used in investing activities   (1,255,456 )   (584,361 )   (606,756 )
 
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from sale of common stock, net of costs 134,863,475 91,374,649 42,771,353
Proceeds from exercise of options 989,060 1,232,579 345,746
Proceeds from exercise of warrants 1,373,000 366,000 181,000
     
 
Net cash provided by financing activities   137,225,535     92,973,228     43,298,099  
 
Increase (decrease) in cash 66,827,746 13,344,748 (2,829,653 )
Cash, beginning of period   64,706,355     51,361,607     54,191,260  
Cash, end of period $ 131,534,101   $ 64,706,355   $ 51,361,607  

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