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TherapeuticsMD Announces Second Quarter 2018 Financial Results

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-Imvexxy™ early experience program underway; national launch to
commence August 6, 2018-

-PDUFA target action date of October 28, 2018 for TX-001HR-

TherapeuticsMD, Inc. (NASDAQ:TXMD), an innovative women's healthcare
company, today announced its financial results for the quarter ended
June 30, 2018.

Second Quarter and Recent Developments

  • Received FDA approval of Imvexxy™ (estradiol vaginal inserts) on May
    29, 2018 for the treatment of moderate-to-severe dyspareunia (vaginal
    pain associated with sexual activity), a symptom of vulvar and vaginal
    atrophy (VVA), due to menopause.
  • Completed the first drawdown of $75 million on June 7, 2018 under its
    previously announced $200 million term loan facility with MidCap
    Financial, managed by Apollo Capital Management, L.P, to support the
    commercial launch of its recently approved product.
  • Initiated Imvexxy's limited launch (early experience program) on July
    9, 2018 with the 10 mcg dose, which will be followed by the national
    launch of the 10 mcg dose that is expected to commence on August 6,
    2018. In the first three weeks of limited launch (July 9-27, 2018),
    approximately 1,363 healthcare providers have initiated at least one
    patient on treatment and sent in the follow-on prescription for
    continuation of treatment on the maintenance pack. The 4 mcg dose of
    Imvexxy is expected to be available in early September 2018.
  • Net revenue for the company's prescription prenatal vitamin business
    was approximately $3.8 million for the second quarter of 2018,
    compared with approximately $4.3 million for the second quarter of
    2017.
  • Net loss was approximately $33.2 million for the second quarter of
    2018, compared with approximately $19.7 million for the second quarter
    of 2017.
  • Ended the quarter with approximately $154.4 million in cash and
    approximately $73.1 million in outstanding debt.
  • Grew the company's intellectual property portfolio to a current total
    of 237 global patent applications with 20 issued foreign patents and
    19 issued U.S. patents.

"We made important progress during the first half of 2018 that has given
us an exciting start to the year," said Robert G. Finizio, Chief
Executive Officer of TherapeuticsMD. "We are focused on commercial and
operational execution with the launch of Imvexxy and an approaching
PDUFA date for TX-001HR."

Summary of Second Quarter 2018 Financial Results

Net revenue from the company's prescription prenatal vitamin business
was approximately $3.8 million for the second quarter of 2018 compared
with net revenue of approximately $4.3 million for the prior year's
quarter. This decrease was primarily attributable to a decrease in the
average net revenue per unit of the company's products, which was
primarily related to higher estimates related to offered discounts in
2018, partially offset by an increase in the number of units sold.

Cost of goods sold was approximately $0.5 million for the second quarter
of 2018, compared with approximately $0.7 million for the prior year's
quarter.

Total operating expenses for the second quarter of 2018 included
research and development (R&D) expenses and sales, general, and
administrative expenses (SG&A). R&D expenses for the second quarter of
2018 were approximately $6.8 million compared with approximately $8.7
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 second quarter of 2018 were approximately $29.5 million
compared with approximately $14.6 million for the prior year's quarter,
primarily due to higher sales, marketing, and personnel costs to support
commercialization of Imvexxy and pre-commercialization expenses for
TX-001HR.

Net loss for the second quarter of 2018 was approximately $33.2 million,
or $0.15 per basic and diluted share, compared with approximately $19.7
million, or $0.10 per basic and diluted share, for the second quarter of
2017.

Balance Sheet

As of June 30, 2018, the company's cash on hand totaled approximately
$154.4 million, compared with approximately $127.1 million at December
31, 2018. Total outstanding debt, net of issuance of costs, was
approximately $73.1 million as of June 30, 2018.

Conference Call and Webcast Details

TherapeuticsMD will host a conference call and audio webcast this
morning, July 30, 2018, at 8:30 a.m. ET to present second quarter 2018
results and provide a business update.

           

Date:

Monday, July 30, 2018

Time:

8:30 a.m. EST

Telephone Access (US):

866-665-9531

Telephone Access (International):

724-987-6977

Access Code for All Callers:

8884867
 

A live webcast and audio archive for the event may be accessed on the
home page or from the "Investors & Media" section of the TherapeuticsMD
website at www.therapeuticsmd.com.
Please connect to the website prior to the start of the presentation to
ensure adequate time for any software downloads that may be necessary to
listen to the webcast. A replay of the webcast will be archived on the
website for at least 30 days. In addition, 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: 8884867

About Imvexxy

Imvexxy (estradiol vaginal inserts) is approved in the U.S. for the
treatment of moderate-to-severe dyspareunia (vaginal pain associated
with sexual activity), a symptom of vulvar and vaginal atrophy (VVA),
due to menopause. Imvexxy is the only product in its therapeutic class
to offer a 4 mcg and 10 mcg dose, the 4 mcg representing the lowest
approved dose of vaginal estradiol available. The full
prescribing information
may be viewed by visiting www.Imvexxy.com.

IMPORTANT SAFETY INFORMATION FOR IMVEXXY

 
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST
CANCER and PROBABLE DEMENTIA

See full prescribing information for complete boxed warning.

 
 

Estrogen-Alone Therapy

•There is an increased risk of endometrial cancer in a woman with
a uterus who uses unopposed estrogens
•Estrogen-alone therapy should not be used for the prevention of
cardiovascular disease or dementia
•The Women's Health Initiative (WHI) estrogen-alone substudy
reported increased risks of stroke and deep vein thrombosis (DVT)
•The WHI Memory Study (WHIMS) estrogen-alone ancillary study of
WHI reported an increased risk of probable dementia in
postmenopausal women 65 years of age and older
 
 

Estrogen Plus Progestin Therapy

•Estrogen plus progestin therapy should not be used for the
prevention of cardiovascular disease or dementia
•The WHI estrogen plus progestin substudy reported increased
risks of stroke, DVT, pulmonary embolism (PE) and myocardial
infarction (MI)
•The WHI estrogen plus progestin substudy reported increased
risks of invasive breast cancer
•The WHIMS estrogen plus progestin ancillary study of WHI
reported an increased risk of probable dementia in postmenopausal
women 65 years of age and older
 

CONTRAINDICATIONS

  • Imvexxy™ is contraindicated in women with any of the following
    conditions: undiagnosed abnormal genital bleeding; known, suspected,
    or history of breast cancer; known or suspected estrogen-dependent
    neoplasia; active DVT, PE, or history of these conditions; active
    arterial thromboembolic disease or a history of these conditions;
    known anaphylactic reaction or angioedema to Imvexxy; known liver
    impairment or disease; known protein C, protein S, or antithrombin
    deficiency, or other known thrombophilic disorders.

WARNINGS AND PRECAUTIONS

  • Imvexxy is intended only for vaginal administration. Systemic
    absorption may occur with the use of Imvexxy.
  • The use of estrogen-alone and estrogen plus progestin therapy has been
    reported to result in an increase in abnormal mammograms requiring
    further evaluation.
  • The WHI estrogen plus progestin substudy reported a statistically
    non-significant increased risk of ovarian cancer. A meta-analysis of
    17 prospective and 35 retrospective epidemiology studies found that
    women who used hormonal therapy for menopausal symptoms had an
    increased risk for ovarian cancer. The exact duration of hormone
    therapy use associated with an increased risk of ovarian cancer,
    however, is unknown.
  • Other warnings include: gallbladder disease; severe hypercalcemia,
    loss of vision, severe hypertriglyceridemia or cholestatic jaundice.
  • Estrogen therapy may cause an exacerbation of asthma, diabetes
    mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus,
    and hepatic hemangiomas and should be used with caution in women with
    these conditions.
  • Women on thyroid replacement therapy should have their thyroid
    function monitored.

ADVERSE REACTIONS

  • The most common adverse reaction with Imvexxy (incidence ≥ 3 percent)
    and greater than placebo was headache.

Please note that this information is not comprehensive. Please visit www.Imvexxy.com
for the
Full
Prescribing Information
, including the Boxed Warning.

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 recently received FDA approval for TX-004HR, branded as
Imvexxy™ (estradiol vaginal inserts), for the treatment of moderate to
severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to
menopause. The company's late stage clinical pipeline includes TX-001HR
being evaluated for treatment of moderate-to-severe vasomotor symptoms
(VMS) 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: whether the FDA will approve the NDA for the
company's TX-001HR product candidate and whether such approval will
occur by the PDUFA target action 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 be able to comply with
the covenants and conditions under its term loan agreement; 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
or adversely affect the commercialization of the company's current or
future approved products; 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, 2018 December 31, 2017
(Unaudited)
 
ASSETS
Current Assets:
Cash $ 154,386,930 $ 127,135,628

Accounts receivable, net of allowance for doubtful accounts of
$418,604 and $380,580, respectively

5,625,987 4,328,802
Inventory 1,880,577 1,485,358
Other current assets   5,203,734     6,604,284  
Total current assets   167,097,228     139,554,072  
 
Fixed assets, net   403,574     437,055  
 
Other Assets:
Intangible assets, net 3,488,401 3,099,747
Prepaid expenses-long term 759,229 -
Security deposit   150,522     139,036  
Total other assets   4,398,152     3,238,783  
Total assets $ 171,898,954   $ 143,229,910  
 
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Accounts payable $ 11,427,160 $ 4,097,600
Accrued expenses and other current liabilities   9,785,210     9,223,595  
Total current liabilities   21,212,370     13,321,195  
 
Long-term Liabilities:
Long-term debt   73,141,311     -  
Total long-term liabilities   73,141,311     -  
Total liabilities   94,353,681     13,321,195  
 
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:
216,834,059 and 216,429,642 issued and outstanding, respectively

216,834 216,430
Additional paid-in capital 521,608,436 516,351,405
Accumulated deficit   (444,279,997 )   (386,659,120 )
Total stockholders' equity   77,545,273     129,908,715  
Total liabilities and stockholders' equity $ 171,898,954   $ 143,229,910  
 
     
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
   
Three Months Ended Six Months Ended
June 30, June 30,
2018 2017 2018 2017
 
Revenues, net $ 3,763,010 $ 4,250,433 $ 7,536,402 $ 8,235,897
 
Cost of goods sold   454,161     681,725     1,087,784     1,341,360  
Gross profit   3,308,849     3,568,708     6,448,618     6,894,537  
 
Operating expenses:
Sales, general, and administration 29,466,770 14,628,927 50,224,007 31,466,544
Research and development 6,798,380 8,716,395 13,837,677 16,441,235
Depreciation and amortization   65,603     53,189     125,224     102,888  
Total operating expense   36,330,753     23,398,511     64,186,908     48,010,667  
 
Operating loss   (33,021,904 )   (19,829,803 )   (57,738,290 )   (41,116,130 )
 
Other income (expense):
Miscellaneous income 334,238 149,054 648,795 275,022
Accreted interest - 3,832 - 7,699
Interest expense   (531,382 )   -     (531,382 )   -  
Total other (expense) income   (197,144 )   152,886     117,413     282,721  
 
Loss before taxes (33,219,048 ) (19,676,917 ) (57,620,877 ) (40,833,409 )
 
Provision for income taxes   -     -     -     -  
 
Net loss $ (33,219,048 ) $ (19,676,917 ) $ (57,620,877 ) $ (40,833,409 )
 
Net loss per share, basic and diluted $ (0.15 ) $ (0.10 ) $ (0.27 ) $ (0.20 )
 

Weighted average number of common shares outstanding

  216,640,186     203,384,610     216,583,067     200,602,778  
 
   
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
 
Six Months Ended
June 30, 2018 June 30, 2017
 
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss $ (57,620,877 ) $ (40,833,409 )

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

Depreciation of fixed assets 79,201 69,000
Amortization of intangible assets 46,023 33,888
Provision for (recovery of) doubtful accounts 38,024 (18,106 )
Share-based compensation 4,128,440 3,051,357
Amortization of deferred financing costs 30,155 -
Changes in operating assets and liabilities:
Accounts receivable (1,335,209 ) 1,122,386
Inventory (395,219 ) (337,694 )
Other current assets 2,539,394 (58,601 )
Accounts payable 7,329,560 749,520
Accrued interest 501,227 -
Accrued expenses and other current liabilities   60,388     (2,443,867 )
Net cash used in operating activities   (44,598,893 )   (38,665,526 )
 
CASH FLOWS FROM INVESTING ACTIVITIES
Patent costs (434,677 ) (367,602 )
Purchase of fixed assets (45,720 ) (35,849 )
Payment of security deposit   (11,486 )   -  
Net cash used in investing activities   (491,883 )   (403,451 )
 
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from term loan 75,000,000 -
Payment of deferred financing fees (3,786,918 ) -
Proceeds from exercise of options 1,128,996 212,360
Proceeds from exercise of warrants   -     3,798,999  
Net cash provided by financing activities   72,342,078     4,011,359  
 
Increase (decrease) in cash 27,251,302 (35,057,618 )
Cash, beginning of period   127,135,628     131,534,101  
Cash, end of period $ 154,386,930   $ 96,476,483  
 

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