TherapeuticsMD Announces First Quarter 2017 Financial Results

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BOCA RATON, Fla.–(BUSINESS WIRE)–TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare
company, today announced its financial results for the quarter ended
March 31, 2017.

First Quarter and Recent Developments

  • Net revenue for the company’s prescription prenatal vitamin business
    was approximately $4.0 million for the first quarter of 2017 compared
    with approximately $4.9 million for the first quarter of 2016.
  • Net loss was approximately $21.2 million for the first quarter of
    2017, compared with approximately $20.9 million for the first quarter
    of 2016.
  • Ended the quarter with approximately $113.5 million in cash and no
    debt.
  • Anticipate FDA action on the New Drug Application (NDA) for TX-004HR
    on or before the originally scheduled Prescription Drug User Fee Act
    (PDUFA) target action date of May 7, 2017. TX-004HR is 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.
  • Presented two posters at ENDO 2017 reviewing data from the Replenish
    Trial, a phase 3 clinical trial of TX-001HR, the company’s
    investigational 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. The results
    from the trial in 1,835 postmenopausal women demonstrated that
    multiple doses of TX-001HR resulted in a statistically significant and
    clinically meaningful reduction from baseline in both the frequency
    and severity of hot flashes compared to placebo. The company plans to
    submit the NDA for TX-001HR as early as the third quarter of 2017.
  • Launched BIO-IGNITETM, 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.
    Through the BIO-IGNITETM program, the company currently has
    a distribution agreement with Premier Value Pharmacy Compounding
    Network (PVPCN), representing over 300 pharmacies and 1.5 million
    annual prescriptions of compounded bio-identical estradiol and
    progesterone (E+P), to dispense the company’s products in lieu of
    compounding, if approved. The company has also received prescription
    data from over 400 additional pharmacies, representing over 500,000
    annual prescriptions of compounded bio-identical E+P.
  • Grew the company’s intellectual property portfolio to a current total
    of 158 patent filings, including 82 international filings, with one
    allowed and 17 issued U.S. patents.

“We are focused on advancing our pipeline of novel hormone therapies
and, if approved, bringing new, differentiated treatment options to
women suffering from symptoms of menopause,” said TherapeuticsMD CEO
Robert G. Finizio.

Summary of First Quarter 2017 Financial Results

Net revenue from the company’s prescription prenatal vitamin business
was approximately $4.0 million for the first quarter of 2017 compared
with net revenue of approximately $4.9 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.

Cost of goods sold was approximately $0.7 million for the first quarter
of 2017, compared with approximately $1.1 million in the prior year’s
quarter.

Total operating expenses for the first quarter of 2017 included research
and development (R&D) expenses and sales, general, and administrative
expenses (SG&A). R&D expenses during the first quarter of 2017 were
approximately $7.7 million compared with approximately $15.1 million for
the prior year’s quarter. The decrease in R&D was a direct result of the
completion of the Replenish Trial for TX-001HR. SG&A expenses for the
first quarter of 2017 were approximately $16.8 million compared with
approximately $9.7 million for the prior year’s quarter, primarily due
to higher sales, marketing, regulatory expenditures, and personnel costs
to support future commercialization.

Net loss for the first quarter of 2017 was approximately $21.2 million,
or $0.11 per basic and diluted share, compared with approximately $20.9
million, or $0.11 per basic and diluted share, for the first quarter of
2016.

At March 31, 2017, cash on hand was approximately $113.5 million,
compared with approximately $131.5 million at December 31, 2016.

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 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 resolve the deficiencies
identified by the FDA in the company’s NDA for its TX-004HR product
candidate; 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 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 an NDA for its TX-001HR product candidate and, if prepared,
whether the FDA will accept and approve the NDA; 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
     
March 31, 2017 December 31, 2016
(Unaudited)
 
ASSETS
Current Assets:
Cash $ 113,525,419 $ 131,534,101

Accounts receivable, net of allowance for doubtful accounts of
$374,771 and $376,374, respectively

3,921,359 4,500,699
Inventory 1,338,618 1,076,321
Other current assets   2,488,121     2,299,052  
Total current assets   121,273,517     139,410,173  
 
Fixed assets, net   511,073     516,839  
 
Other Assets:
Intangible assets, net 2,497,360 2,405,972
Security deposit   139,036     139,036  
Total other assets   2,636,396     2,545,008  
Total assets $ 124,420,986   $ 142,472,020  
 
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts payable $ 6,146,278 $ 7,358,514
Other current liabilities   7,940,723     7,624,085  
Total current liabilities   14,087,001     14,982,599  
 
 
Commitments and Contingencies
 
Stockholders’ Equity:

Preferred stock – par value $0.001; 10,000,000 shares authorized;
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:
198,593,268 and 196,688,222 issued and outstanding, respectively

198,593 196,688
Additional paid-in capital 441,025,624 436,995,052
Accumulated deficit   (330,890,232 )   (309,702,319 )
Total stockholders’ equity   110,333,985     127,489,421  
Total liabilities and stockholders’ equity $ 124,420,986   $ 142,472,020  
 
 
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
 
    Three Months Ended
March 31, 2017   March 31, 2016
 
 
Revenues, net $ 3,985,464 $ 4,930,091
 
Cost of goods sold   659,635     1,108,443  
 
Gross profit   3,325,829     3,821,648  
 
Operating expenses:
Sales, general, and administrative 16,837,617 9,678,552
Research and development 7,724,840 15,097,017
Depreciation and amortization   49,699     19,597  
Total operating expenses   24,612,156     24,795,166  
 
Operating loss   (21,286,327 )   (20,973,518 )
 
Other income
Miscellaneous income 125,968 41,617
Accreted interest   3,867     2,536  
Total other income   129,835     44,153  
 
Loss before income taxes (21,156,492 ) (20,929,365 )
 
Provision for income taxes        
 
Net loss $ (21,156,492 ) $ (20,929,365 )
 
Loss per share, basic and diluted:
 
Net loss per share, basic and diluted $ (0.11 ) $ (0.11 )
 

Weighted average number of common shares outstanding, basic and
diluted

  197,790,040     194,901,560  
 
 
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
     
Three Months Ended
March 31, 2017   March 31, 2016
 
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss $ (21,156,492 ) $ (20,929,365 )

Adjustments to reconcile net loss to net cash used in operating
activities:

Depreciation 33,600 8,363
Amortization of intangible assets 16,099 11,234
(Recovery of) provision for doubtful accounts (1,603 ) 236,151
Share-based compensation 1,413,195 4,381,690
Changes in operating assets and liabilities:
Accounts receivable 580,943 (2,250,209 )
Inventory (262,297 ) (267,281 )
Other current assets (253,518 ) 477,312
Other assets (2,536 )
Accounts payable (1,212,236 ) 304,475
Other current liabilities   316,638     (1,373,762 )
 
Net cash used in operating activities   (20,525,671 )   (19,403,928 )
 
CASH FLOWS FROM INVESTING ACTIVITIES
Patent costs (107,487 ) (90,529 )
Purchase of fixed assets   (27,834 )   (74,478 )
 
Net cash used in investing activities   (135,321 )   (165,007 )
 
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from sale of common stock, net of costs 134,863,475
Proceeds from exercise of options 192,310 786,450
Proceeds from exercise of warrants   2,460,000     1,310,000  
 
Net cash provided by financing activities   2,652,310     136,959,925  
 
(Decrease) increase in cash (18,008,682 ) 117,390,990
Cash, beginning of period   131,534,101     64,706,355  
Cash, end of period $ 113,525,419   $ 182,097,345  
 

Contacts

Investor Contact
TherapeuticsMD,
Inc.
David DeLucia, 561-961-1900
Director, Investor Relations
David.DeLucia@TherapeuticsMD.com
or
Media
Contact

SparkBioComm
Ami Knoefler, 650-739-9952
Ami@SparkBioComm.com