- Resubmission of New Drug Application for TX-004HR expected in the coming weeks -
- Submission of New Drug Application for TX-001HR expected in
Third Quarter and Recent Developments
-
On
November 3, 2017 , the Company participated in an in-person meeting with theDivision of Bone , Reproductive, and Urologic Products of theFood and Drug Administration (FDA ). At the meeting, the Division agreed to the resubmission of the New Drug Application (NDA) for TX-004HR without the need for an additional pre-approval study. The Company will commit to conduct a post-approval observational study. The Company plans to resubmit the NDA for TX-004HR in the coming weeks. -
Presented five oral abstracts at NAMS 2017 reviewing data fromthe
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-001HRresulted ina 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 in
December 2017 . -
Net revenue for the company’s prescription prenatal vitamin business
was approximately
$4.4 million for the third quarter of 2017 compared with approximately$5.5 million for the third quarter of 2016. -
Net loss was approximately
$14.7 million for the third quarter of 2017, compared with approximately$25.0 million for the third quarter of 2016. -
Ended the quarter with approximately
$148.3 million in cash and no debt, which includes approximately$68.6 million in net proceeds from an equity offering inSeptember 2017 . - Grew the company’s intellectual property portfolio to a current total of 158 patent filings, including 82 international filings, with one allowed and 18 issued U.S. patents.
“We continue to focus on advancing our pipeline of novel hormone
therapies and, if approved, bringing new, differentiated treatment
options to women suffering from symptoms of menopause,” said
Summary of Third Quarter 2017 Financial Results
Net revenue from the company’s prescription prenatal vitamin business
was approximately
Cost of goods sold was approximately
Total operating expenses for the third quarter of 2017 included research
and development (R&D) expenses and sales, general, and administrative
expenses (SG&A). R&D expenses for the third quarter of 2017 were
approximately
Net loss for the third quarter of 2017 was approximately
At
About
Forward-Looking Statements
This press release by
THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||||||
CONSOLIDATED BALANCE SHEETS | |||||||||||
September 30, 2017 | December 31, 2016 | ||||||||||
(Unaudited) | |||||||||||
ASSETS | |||||||||||
Current Assets: | |||||||||||
Cash | $ | 148,292,654 | $ | 131,534,101 | |||||||
Accounts receivable, net of allowance for doubtful accounts of $377,929 and $376,374, respectively |
4,392,635 | 4,500,699 | |||||||||
Inventory | 1,293,517 | 1,076,321 | |||||||||
Other current assets | 3,001,777 | 2,299,052 | |||||||||
Total current assets | 156,980,583 | 139,410,173 | |||||||||
Fixed assets, net | 448,066 | 516,839 | |||||||||
Other Assets: | |||||||||||
Intangible assets, net | 2,793,421 | 2,405,972 | |||||||||
Security deposit | 139,036 | 139,036 | |||||||||
Total other assets | 2,932,457 | 2,545,008 | |||||||||
Total assets | $ | 160,361,106 | $ | 142,472,020 | |||||||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||||||
Current Liabilities: | |||||||||||
Accounts payable | $ | 4,199,369 | $ | 7,358,514 | |||||||
Other current liabilities | 6,677,232 | 7,624,085 | |||||||||
Total current liabilities | 10,876,601 | 14,982,599 | |||||||||
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; 216,429,642 and 196,688,222 issued and outstanding, respectively |
216,430 | 196,688 | |||||||||
Additional paid in capital | 514,499,865 | 436,995,052 | |||||||||
Accumulated deficit | (365,231,790 | ) | (309,702,319 | ) | |||||||
Total stockholders' equity | 149,484,505 | 127,489,421 | |||||||||
Total liabilities and stockholders' equity | $ | 160,361,106 | $ | 142,472,020 | |||||||
THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||||||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||||||
(Unaudited) | |||||||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||||||
September 30, | September 30, | ||||||||||||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||||||||||||
Revenues, net | $ | 4,417,598 | $ | 5,535,685 | $ | 12,653,495 | $ | 14,869,023 | |||||||||||||
Cost of goods sold | 700,814 | 1,237,446 | 2,042,174 | 3,475,997 | |||||||||||||||||
Gross profit | 3,716,784 | 4,298,239 | 10,611,321 | 11,393,026 | |||||||||||||||||
Operating expenses: | |||||||||||||||||||||
Sales, general, and administration | 12,057,868 | 14,721,710 | 43,524,412 | 35,019,268 | |||||||||||||||||
Research and development | 6,436,802 | 14,664,123 | 22,878,037 | 43,602,333 | |||||||||||||||||
Depreciation and amortization | 54,055 | 40,460 | 156,943 | 84,319 | |||||||||||||||||
Total operating expense | 18,548,725 | 29,426,293 | 66,559,392 | 78,705,920 | |||||||||||||||||
Operating loss | (14,831,941 | ) | (25,128,054 | ) | (55,948,071 | ) | (67,312,894 | ) | |||||||||||||
Other income: | |||||||||||||||||||||
Miscellaneous income | 167,300 | 109,942 | 442,322 | 265,879 | |||||||||||||||||
Accreted interest | - | 2,451 | 7,699 | 7,850 | |||||||||||||||||
Total other income | 167,300 | 112,393 | 450,021 | 273,729 | |||||||||||||||||
Loss before taxes | (14,664,641 | ) | (25,015,661 | ) | (55,498,050 | ) | (67,039,165 | ) | |||||||||||||
Provision for income taxes | - | - | - | - | |||||||||||||||||
Net loss | $ | (14,664,641 | ) | $ | (25,015,661 | ) | $ | (55,498,050 | ) | $ | (67,039,165 | ) | |||||||||
Net loss per share, basic and diluted | $ | (0.07 | ) | $ | (0.13 | ) | $ | (0.27 | ) | $ | (0.34 | ) | |||||||||
Weighted average number of common shares outstanding |
207,938,338 | 196,502,327 | 203,282,335 | 195,912,173 | |||||||||||||||||
THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||||||
CONSOLIDATED STATEMENTS OF CASH FLOWS | |||||||||||
(Unaudited) | |||||||||||
Nine Months Ended | |||||||||||
September 30, 2017 | September 30, 2016 | ||||||||||
CASH FLOWS FROM OPERATING ACTIVITIES | |||||||||||
Net loss | $ | (55,498,050 | ) | $ | (67,039,165 | ) | |||||
Adjustments to reconcile net loss to net cash flows used in operating activities: |
|||||||||||
Depreciation of fixed assets | 104,622 | 45,759 | |||||||||
Amortization of intangible assets | 52,321 | 38,560 | |||||||||
Provision for doubtful accounts | 1,555 | 2,261,568 | |||||||||
Share-based compensation | 5,037,783 | 13,385,215 | |||||||||
Changes in operating assets and liabilities: | |||||||||||
Accounts receivable | 106,509 | (4,245,151 | ) | ||||||||
Inventory | (217,196 | ) | (153,245 | ) | |||||||
Other current assets | (831,623 | ) | 379,930 | ||||||||
Accounts payable | (3,159,145 | ) | 1,098,245 | ||||||||
Other current liabilities | (946,853 | ) | 703,895 | ||||||||
Net cash used in operating activities | (55,350,077 | ) | (53,524,389 | ) | |||||||
CASH FLOWS FROM INVESTING ACTIVITIES | |||||||||||
Patent costs | (439,770 | ) | (541,686 | ) | |||||||
Purchase of fixed assets | (35,849 | ) | (307,714 | ) | |||||||
Payment of security deposit | - | (14,036 | ) | ||||||||
Net cash used in investing activities | (475,619 | ) | (863,436 | ) | |||||||
CASH FLOWS FROM FINANCING ACTIVITIES | |||||||||||
Proceeds from sale of common stock, net of costs | 68,572,635 | 134,863,475 | |||||||||
Proceeds from exercise of warrants | 3,798,999 | 1,373,000 | |||||||||
Proceeds from exercise of options | 212,615 | 979,060 | |||||||||
Net cash provided by financing activities | 72,584,249 | 137,215,535 | |||||||||
Increase in cash | 16,758,553 | 82,827,710 | |||||||||
Cash, beginning of period | 131,534,101 | 64,706,355 | |||||||||
Cash, end of period | $ | 148,292,654 | $ | 147,534,065 | |||||||
View source version on businesswire.com: http://www.businesswire.com/news/home/20171106005451/en/
Source:
TherapeuticsMD, Inc.
David DeLucia, 561-961-1900
Director,
Investor Relations
David.DeLucia@TherapeuticsMD.com