TherapeuticsMD Announces First Quarter 2017 Financial Results
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 |
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; |
– | – | |||||||
Common stock – par value $0.001; 350,000,000 shares authorized: |
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 |
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 |
||||||||||
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