- Topline phase 3 data for TX-001HR Replenish Trial on track for fourth quarter of 2016 -
- TX-004HR PDUFA target action date of
Third Quarter and Recent Developments
-
Announced acceptance of a New Drug Application (NDA) by the
U.S. Food and Drug Administration (FDA ) for TX-004HR (conditionally-approved trade name Yuvvexy™), 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. The NDA is supported by the complete TX-004HR clinical program, including positive phase 3 results with all three doses of TX-004HR (4 mcg, 10 mcg and 25 mcg) that were evaluated in the Rejoice Trial. The FDA’s Prescription Drug User Fee Act (PDUFA) target action date for the NDA isMay 7, 2017 . -
Anticipate topline results in the fourth quarter of 2016 for the
ongoing Replenish Trial, a phase 3 clinical trial of the company’s
TX-001HR product candidate, which, if approved, would be the first and
only
FDA -approved bio-identical combination of estradiol and progesterone for the treatment of moderate-to-severe vasomotor symptoms due to menopause. -
Net revenue from the company’s prescription prenatal vitamin business
increased 7 percent to approximately
$5.5 million for the third quarter of 2016, compared with approximately$5.2 million for the third quarter of 2015. -
Net loss was approximately
$25.0 million for the third quarter of 2016, compared with approximately$19.5 million for the third quarter of 2015. -
Ended the quarter with approximately
$147.5 million in cash and no debt. -
Supported nine presentations at annual meetings of the
International Menopause Society (IMS) andNorth American Menopause Society (NAMS), including reports on the positive results from the TX-004HR clinical development program and new data that further identify women’s perceptions of VVA and available treatment options. - Grew the company’s intellectual property portfolio to a current total of 149 patent filings, including 82 international filings, with 17 issued U.S. patents.
- Strengthened relationships with medical, pharmacy, patient and industry organizations internationally.
“We are making excellent progress this year advancing our pipeline and
enhancing our commercial capabilities focused on women’s health. During
the quarter, we successfully completed the submission of our NDA for
TX-004HR as a novel treatment for moderate to severe dyspareunia, a
symptom of VVA due to menopause, and we continued ongoing
pre-commercialization activities for this important product,” said
Summary of Third Quarter 2016 Financial Results
Net revenue from the company’s prescription prenatal vitamins increased
7 percent to approximately
Cost of goods sold was approximately
Total operating expenses for the third quarter of 2016 included research
and development (R&D) expenses and sales, general and administrative
expenses (SG&A). R&D expenses during the third quarter of 2016 were
approximately
Net loss for the third quarter of 2016 was approximately
At
Conference Call Today
As previously announced,
Date: |
Thursday, November 3, 2016 |
|||||||||||
Time: |
4:30 p.m. EDT |
|||||||||||
Telephone Access (US): |
866-665-9531 |
|||||||||||
Telephone Access (International): |
724-987-6977 |
|||||||||||
Access Code for All Callers: |
99198056 |
Additionally, a live webcast can be accessed on the company’s website, www.therapeuticsmd.com, in the “Investors & Media” section. 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: 99198056.
About
Forward-Looking Statements
This press release by
THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||||
CONSOLIDATED BALANCE SHEETS | |||||||||
September 30, 2016 | December 31, 2015 | ||||||||
(Unaudited) | |||||||||
ASSETS | |||||||||
Current Assets: | |||||||||
Cash | $ | 147,534,065 | $ | 64,706,355 | |||||
Accounts receivable, net of allowance for doubtful accounts | |||||||||
of $113,034 and $81,910, respectively | 5,033,298 | 3,049,715 | |||||||
Inventory | 843,398 | 690,153 | |||||||
Other current assets | 2,693,475 | 2,233,897 | |||||||
Total current assets | 156,104,236 | 70,680,120 | |||||||
Fixed assets, net | 460,546 | 198,592 | |||||||
Other Assets: | |||||||||
Intangible assets, net | 2,118,378 | 1,615,251 | |||||||
Prepaid expense | - | 1,109,883 | |||||||
Security deposit | 139,036 | 125,000 | |||||||
Total other assets | 2,257,414 | 2,850,134 | |||||||
Total assets | $ | 158,822,196 | $ | 73,728,846 | |||||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||||
Current Liabilities: | |||||||||
Accounts payable | $ | 4,224,419 | $ | 3,126,174 | |||||
Other current liabilities | 8,243,421 | 7,539,526 | |||||||
Total current liabilities | 12,467,840 | 10,665,700 | |||||||
Total liabilities | 12,467,840 | 10,665,700 | |||||||
Commitments and Contingencies - See Note 15 | |||||||||
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; | |||||||||
196,580,212 and 177,928,041 issued and outstanding, respectively | 196,580 | 177,928 | |||||||
Additional paid in capital | 433,023,801 | 282,712,078 | |||||||
Accumulated deficit | (286,866,025 | ) | (219,826,860 | ) | |||||
Total stockholders' equity | 146,354,356 | 63,063,146 | |||||||
Total liabilities and stockholders' equity | $ | 158,822,196 | $ | 73,728,846 | |||||
THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||||||||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||||||||
(Unaudited) | |||||||||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||||||||
September 30, | September 30, | ||||||||||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||||||||||
Revenues, net | $ | 5,535,685 | $ | 5,190,175 | $ | 14,869,023 | $ | 14,513,158 | |||||||||||||||
Cost of goods sold | 1,237,446 | 1,193,965 | 3,475,997 | 3,270,695 | |||||||||||||||||||
Gross profit | 4,298,239 | 3,996,210 | 11,393,026 | 11,242,463 | |||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||
Sales, general, and administration | 14,721,710 | 7,060,944 | 35,019,268 | 20,089,998 | |||||||||||||||||||
Research and development | 14,664,123 | 16,421,753 | 43,602,333 | 58,789,302 | |||||||||||||||||||
Depreciation and amortization | 40,460 | 16,548 | 84,319 | 44,400 | |||||||||||||||||||
Total operating expense | 29,426,293 | 23,499,245 | 78,705,920 | 78,923,700 | |||||||||||||||||||
Operating loss | (25,128,054 | ) | (19,503,035 | ) | (67,312,894 | ) | (67,681,237 | ) | |||||||||||||||
Other income: | |||||||||||||||||||||||
Miscellaneous income | 109,942 | 27,630 | 265,879 | 71,728 | |||||||||||||||||||
Accreted interest | 2,451 | 2,760 | 7,850 | 15,162 | |||||||||||||||||||
Total other income | 112,393 | 30,390 | 273,729 | 86,890 | |||||||||||||||||||
Loss before taxes | (25,015,661 | ) | (19,472,645 | ) | (67,039,165 | ) | (67,594,347 | ) | |||||||||||||||
Provision for income taxes | - | - | - | - | |||||||||||||||||||
Net loss | $ | (25,015,661 | ) | $ | (19,472,645 | ) | $ | (67,039,165 | ) | $ | (67,594,347 | ) | |||||||||||
Net loss per share, basic and diluted | $ | (0.13 | ) | $ | (0.11 | ) | $ | (0.34 | ) | $ | (0.39 | ) | |||||||||||
Weighted average number of common | |||||||||||||||||||||||
shares outstanding | 196,502,327 | 177,206,168 | 195,912,173 | 171,589,595 | |||||||||||||||||||
THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||||
CONSOLIDATED STATEMENTS OF CASH FLOWS | |||||||||
(Unaudited) | |||||||||
Nine Months Ended | |||||||||
September 30, 2016 | September 30, 2015 | ||||||||
CASH FLOWS FROM OPERATING ACTIVITIES | |||||||||
Net loss | $ | (67,039,165 | ) | $ | (67,594,347 | ) | |||
Adjustments to reconcile net loss to net cash flows used in | |||||||||
operating activities: | |||||||||
Depreciation of fixed assets | 45,759 | 22,104 | |||||||
Amortization of intangible assets | 38,560 | 22,296 | |||||||
Provision for doubtful accounts | 2,261,568 | 37,163 | |||||||
Share-based compensation | 13,385,215 | 4,740,906 | |||||||
Changes in operating assets and liabilities: | |||||||||
Accounts receivable | (4,245,151 | ) | (1,549,532 | ) | |||||
Inventory | (153,245 | ) | 312,054 | ||||||
Other current assets | 379,930 | (621,923 | ) | ||||||
Other assets | - | (15,162 | ) | ||||||
Accounts payable | 1,098,245 | (1,025,504 | ) | ||||||
Deferred revenue | - | (522,613 | ) | ||||||
Other current liabilities | 703,895 | 2,546,138 | |||||||
Other long-term liabilities | - | 1,213,874 | |||||||
Net cash used in operating activities | (53,524,389 | ) | (62,434,546 | ) | |||||
CASH FLOWS FROM INVESTING ACTIVITIES | |||||||||
Patent costs | (541,686 | ) | (117,992 | ) | |||||
Purchase of fixed assets | (307,714 | ) | (15,559 | ) | |||||
Payment of security deposit | (14,036 | ) | - | ||||||
Net cash used in investing activities | (863,436 | ) | (133,551 | ) | |||||
CASH FLOWS FROM FINANCING ACTIVITIES | |||||||||
Proceeds from sale of common stock, net of costs | 134,863,475 | 91,374,649 | |||||||
Proceeds from exercise of warrants | 1,373,000 | 366,000 | |||||||
Proceeds from exercise of options | 979,060 | 589,829 | |||||||
Net cash provided by financing activities | 137,215,535 | 92,330,478 | |||||||
Increase in cash | 82,827,710 | 29,762,381 | |||||||
Cash, beginning of period | 64,706,355 | 51,361,607 | |||||||
Cash, end of period | $ | 147,534,065 | $ | 81,123,988 |
View source version on businesswire.com: http://www.businesswire.com/news/home/20161103006350/en/
Source:
TherapeuticsMD, Inc.
Investor Contact:
David
DeLucia, 561-961-1900
Director, Investor Relations
David.DeLucia@TherapeuticsMD.com
or
Media
Contact:
SparkBioComm
Ami Knoefler, 650-739-9952
Ami@SparkBiocomm.com