Topline phase 3 data anticipated in fourth quarter for TX-004HR to treat symptoms of VVA
Completed enrollment in phase 3 Replenish Trial for first potential
Management to host conference call today at
Recent and Third Quarter Developments
-
Revenues, net for the company’s prescription prenatal vitamin business
increased to approximately
$5.2 million for the third quarter of 2015 compared with approximately$4.2 million for the third quarter of 2014. -
Net loss was approximately
$19.5 million for the third quarter of 2015, compared with approximately$17.8 million for the third quarter of 2014, reflecting the costs of two phase 3 clinical trials for the company’s novel hormone therapy drug candidates. - Completed last patient visit in the Rejoice Trial, a phase 3 clinical trial of TX-004HR, an applicator-free vaginal estradiol softgel drug candidate for the treatment of moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause.
- Completed patient enrollment in the Replenish Trial, a phase 3 clinical trial of TX-001HR, a combination estradiol and progesterone drug candidate, for the treatment of moderate to severe vasomotor symptoms due to menopause.
-
Ended the quarter with approximately
$81.1 million in cash and no debt. - Grew the company’s intellectual property portfolio to a current total of 111 patent filings, including 61 international filings, with two allowed and 13 issued U.S. patents.
-
Supported scientific abstracts and presentations at the annual meeting
of the
North American Menopause Society . - Continued to develop relationships with key medical, pharmacy, patient and industry organizations.
“As we pursue our mission to address women’s health needs, we believe
that there is a unique confluence of factors evolving on the scientific,
regulatory, legislative and commercial fronts that will help us to make
significant progress toward delivering on our vision and strategy,” said
Third Quarter Financial Results Summary
Revenues, net for the third quarter of 2015 increased by 24 percent to
approximately
Cost of goods sold increased to approximately
Total operating expenses for the third quarter of 2015 included research
and development (R&D) expenses and sales, general and administration
(SG&A). R&D expenses for the third quarter of 2015 were approximately
Non-operating income remained insignificant for the third quarter of 2015 and 2014 and included miscellaneous and interest income for both periods.
Net loss for the third quarter of 2015 was approximately
At
Conference Call Today
As previously announced,
Date:
Time:
Telephone
Access (US): 866-665-9531
Telephone Access (International):
724-987-6977
Access Code for All Callers: 61714687
Additionally, a live webcast can be accessed on the company’s website, www.therapeuticsmd.com, on the “Home Page” or under the “Investor” section.
About
This press release by
THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||||
CONSOLIDATED BALANCE SHEETS | |||||||||
September 30, 2015 | December 31, 2014 | ||||||||
(Unaudited) | |||||||||
ASSETS | |||||||||
Current Assets: | |||||||||
Cash | $ | 81,123,988 | $ | 51,361,607 | |||||
Accounts receivable, net of allowance for doubtful accounts | |||||||||
of $96,916 and $59,753, respectively | 3,666,586 | 2,154,217 | |||||||
Inventory | 870,059 | 1,182,113 | |||||||
Other current assets | 2,120,805 | 1,537,407 | |||||||
Total current assets | 87,781,438 | 56,235,344 | |||||||
Fixed assets, net | 56,748 | 63,293 | |||||||
Other Assets: | |||||||||
Prepaid expense | 1,172,051 | 1,427,263 | |||||||
Intangible assets, net | 1,324,284 | 1,228,588 | |||||||
Security deposit | 125,000 | 125,000 | |||||||
Total other assets | 2,621,335 | 2,780,851 | |||||||
Total assets | $ | 90,459,521 | $ | 59,079,488 | |||||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||||
Current Liabilities: | |||||||||
Accounts payable | $ | 5,301,625 | $ | 6,327,129 | |||||
Other current liabilities | 6,386,777 | 3,840,639 | |||||||
Deferred revenue | - | 522,613 | |||||||
Total current liabilities | 11,688,402 | 10,690,381 | |||||||
Long-Term Liabilities: | |||||||||
Accrued expenses | 1,213,874 | - | |||||||
Total liabilities | 12,902,276 | 10,690,381 | |||||||
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 and 250,000,000 shares | |||||||||
authorized; 177,787,927 and 156,097,019 issued and outstanding, respectively | 177,788 | 156,097 | |||||||
Additional paid-in capital | 279,723,640 | 182,982,846 | |||||||
Accumulated deficit | (202,344,183 | ) | (134,749,836 | ) | |||||
Total stockholders' equity | 77,557,245 | 48,389,107 | |||||||
Total liabilities and stockholders' equity | $ | 90,459,521 | $ | 59,079,488 | |||||
THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||||
(Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | ||||||||||||||
Revenues, net | $ | 5,190,175 | $ | 4,186,261 | $ | 14,513,158 | $ | 10,768,572 | |||||||||
Cost of goods sold | 1,193,965 | 1,068,605 | 3,270,695 | 2,792,268 | |||||||||||||
Gross profit | 3,996,210 | 3,117,656 | 11,242,463 | 7,976,304 | |||||||||||||
Operating expenses: | |||||||||||||||||
Sales, general, and administration | 7,060,944 | 6,043,354 | 20,089,998 | 16,610,015 | |||||||||||||
Research and development | 16,421,753 | 14,909,430 | 58,789,302 | 29,052,149 | |||||||||||||
Depreciation and amortization | 16,548 | 12,747 | 44,400 | 39,909 | |||||||||||||
Total operating expenses | 23,499,245 | 20,965,531 | 78,923,700 | 45,702,073 | |||||||||||||
Operating loss | (19,503,035 | ) | (17,847,875 | ) | (67,681,237 | ) | (37,725,769 | ) | |||||||||
Other income (expense): | |||||||||||||||||
Miscellaneous income | 27,630 | 6,260 | 71,728 | 43,411 | |||||||||||||
Interest income | 2,760 | 9,364 | 15,162 | 27,756 | |||||||||||||
Financing costs | - | - | - | (260,027 | ) | ||||||||||||
Total other income (expense) | 30,390 | 15,624 | 86,890 | (188,860 | ) | ||||||||||||
Loss before income taxes | (19,472,645 | ) | (17,832,251 | ) | (67,594,347 | ) | (37,914,629 | ) | |||||||||
Provision for income taxes | - | - | - | - | |||||||||||||
Net loss | $ | (19,472,645 | ) | $ | (17,832,251 | ) | $ | (67,594,347 | ) | $ | (37,914,629 | ) | |||||
Loss per share, basic and diluted: | |||||||||||||||||
Net loss per share, basic and diluted | $ | (0.11 | ) | $ | (0.12 | ) | $ | (0.39 | ) | $ | (0.26 | ) | |||||
Weighted average number of common | |||||||||||||||||
shares outstanding, basic and diluted | 177,206,168 | 152,200,455 | 171,589,595 | 147,594,810 | |||||||||||||
THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||||
CONSOLIDATED STATEMENTS OF CASH FLOWS | |||||||||
(Unaudited) | |||||||||
Nine Months Ended | |||||||||
September 30, 2015 | September 30, 2014 | ||||||||
CASH FLOWS FROM OPERATING ACTIVITIES | |||||||||
Net loss | $ | (67,594,347 | ) | $ | (37,914,629 | ) | |||
Adjustments to reconcile net loss to net cash used in | |||||||||
operating activities: | |||||||||
Depreciation | 22,104 | 22,713 | |||||||
Amortization of intangible assets | 22,296 | 17,196 | |||||||
Provision for doubtful accounts | 37,163 | 2,594 | |||||||
Share-based compensation | 4,740,906 | 3,934,836 | |||||||
Amortization of deferred financing costs | - | 260,027 | |||||||
Changes in operating assets and liabilities: | |||||||||
Accounts receivable | (1,549,532 | ) | (460,565 | ) | |||||
Inventory | 312,054 | 31,673 | |||||||
Other current assets | (621,923 | ) | 197,569 | ||||||
Other assets | (15,162 | ) | (17,069 | ) | |||||
Accounts payable | (1,025,504 | ) | 3,534,462 | ||||||
Deferred revenue | (522,613 | ) | (754,431 | ) | |||||
Other current liabilities | 2,546,138 | 909,890 | |||||||
Long term accrued expenses | 1,213,874 | - | |||||||
Net cash used in operating activities | (62,434,546 | ) | (30,235,734 | ) | |||||
CASH FLOWS FROM INVESTING ACTIVITIES | |||||||||
Patent costs | (117,992 | ) | (193,349 | ) | |||||
Purchase of property and equipment | (15,559 | ) | (30,962 | ) | |||||
Net cash used in investing activities | (133,551 | ) | (224,311 | ) | |||||
CASH FLOWS FROM FINANCING ACTIVITIES | |||||||||
Proceeds from sale of common stock, net of costs | 91,374,649 | 42,771,353 | |||||||
Proceeds from exercise of options | 589,829 | 315,546 | |||||||
Proceeds from exercise of warrants | 366,000 | 181,000 | |||||||
Net cash provided by financing activities | 92,330,478 | 43,267,899 | |||||||
Increase in cash | 29,762,381 | 12,807,854 | |||||||
Cash, beginning of period | 51,361,607 | 54,191,260 | |||||||
Cash, end of period | $ | 81,123,988 | $ | 66,999,114 | |||||
View source version on businesswire.com: http://www.businesswire.com/news/home/20151104005985/en/
Source:
TherapeuticsMD, Inc.
Investors:
Dan Cartwright, 561-961-1900
Chief
Financial Officer
Dan.Cartwright@TherapeuticsMD.com