- NDA filing for TX-004HR planned by end of
- Strong cash position of approximately
First Quarter and Recent Developments
-
Net revenue from the company’s prescription prenatal vitamin business
increased 10 percent to approximately
$4.9 million for the first quarter of 2016, compared with approximately$4.5 million for the first quarter of 2015. -
Net loss was approximately
$21.0 million for the first quarter of 2016, compared with approximately$20.9 million for the first quarter of 2015. -
Ended the quarter with approximately
$182.1 million in cash and no debt. -
Presented posters at
ENDO 2016 and theInternational Society for the Study of Women’sSexual Health (ISSWSH) Annual Meeting 2016 detailing results of the phase 3 Rejoice Trial for Yuvvexy, the conditionally approved trade name for TX-004HR, an applicator-free vaginal estradiol softgel drug candidate 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 findings showed patients treated with Yuvvexy achieved a statistically significant improvement over placebo across all four co-primary endpoints at all three doses evaluated. A New Drug Application filing is planned for Yuvvexy by end ofJune 2016 . - Exited approximately 1,500 of the 1,750 patients enrolled 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. Topline results are currently anticipated late in the fourth quarter of 2016.
- Launched VitaTrue™, the first certified vegan and kosher prescription prenatal multivitamin, which expands the company’s line of prescription prenatal vitamin products and further strengthens its women’s health capabilities.
- Grew the company’s intellectual property portfolio to a current total of 134 patent filings, including 72 international filings, with 17 issued U.S. patents.
- Strengthened relationships with key medical, pharmacy, patient and industry organizations worldwide.
“During the first quarter, we successfully executed on our goals across
the company,” said
Summary of First Quarter 2016 Financial Results
For the quarter ended
Cost of goods sold was approximately
Total operating expenses for the first quarter of 2016 included research
and development (R&D) expenses and sales, general and administrative
expenses (SG&A). R&D expenses during the first quarter of 2016 were
approximately
Non-operating income was insignificant for the first quarter of both 2016 and 2015 and included primarily interest income for both periods.
Net loss for the first quarter of 2016 was approximately
At
Conference Call Today
As previously announced,
Date: |
Tuesday, May 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: |
88600937 |
Additionally, a live webcast can be accessed on the company’s website, www.therapeuticsmd.com, on the Home Page or under 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: 45870409.
About
This press release by
THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||||
CONSOLIDATED BALANCE SHEETS | |||||||||
March 31, 2016 | December 31, 2015 | ||||||||
(Unaudited) | |||||||||
ASSETS | |||||||||
Current Assets: | |||||||||
Cash | $ | 182,097,345 | $ | 64,706,355 | |||||
Accounts receivable, net of allowance for doubtful accounts | |||||||||
of $318,061 and $81,910, respectively | 5,063,773 | 3,049,715 | |||||||
Inventory | 957,434 | 690,153 | |||||||
Other current assets | 1,718,069 | 2,233,897 | |||||||
Total current assets | 189,836,621 | 70,680,120 | |||||||
Fixed assets, net | 264,706 | 198,592 | |||||||
Other Assets: | |||||||||
Intangible assets, net | 1,694,546 | 1,615,251 | |||||||
Prepaid expense | 1,047,970 | 1,109,883 | |||||||
Security deposit | 125,000 | 125,000 | |||||||
Total other assets | 2,867,516 | 2,850,134 | |||||||
Total assets | $ | 192,968,843 | $ | 73,728,846 | |||||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||||
Current Liabilities: | |||||||||
Accounts payable | $ | 3,430,649 | $ | 3,126,174 | |||||
Other current liabilities | 6,165,764 | 7,539,526 | |||||||
Total current liabilities | 9,596,413 | 10,665,700 | |||||||
Total liabilities | 9,596,413 | 10,665,700 | |||||||
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; | |||||||||
196,253,700 and 177,928,041 issued and outstanding, respectively | 196,254 | 177,928 | |||||||
Additional paid-in capital | 423,932,401 | 282,712,078 | |||||||
Accumulated deficit | (240,756,225 | ) | (219,826,860 | ) | |||||
Total stockholders' equity | 183,372,430 | 63,063,146 | |||||||
Total liabilities and stockholders' equity | $ | 192,968,843 | $ | 73,728,846 |
THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||
(Unaudited) | |||||||||
Three Months Ended | |||||||||
March 31, 2016 | March 31, 2015 | ||||||||
Revenues, net | $ | 4,930,091 | $ | 4,475,049 | |||||
Cost of goods sold | 1,108,443 | 1,043,641 | |||||||
Gross profit | 3,821,648 | 3,431,408 | |||||||
Operating expenses: | |||||||||
Sales, general, and administrative | 9,678,552 | 6,163,612 | |||||||
Research and development | 15,097,017 | 18,176,835 | |||||||
Depreciation and amortization | 19,597 | 13,572 | |||||||
Total operating expense | 24,795,166 | 24,354,019 | |||||||
Operating loss | (20,973,518 | ) | (20,922,611 | ) | |||||
Other income | |||||||||
Interest income | 41,617 | 18,513 | |||||||
Accreted interest | 2,536 | 9,842 | |||||||
Total other income | 44,153 | 28,355 | |||||||
Loss before income taxes | (20,929,365 | ) | (20,894,256 | ) | |||||
Provision for income taxes | - | - | |||||||
Net loss | $ | (20,929,365 | ) | $ | (20,894,256 | ) | |||
Net loss per share, basic and diluted | $ | (0.11 | ) | $ | (0.13 | ) | |||
Weighted average number of common | |||||||||
shares outstanding-basic and diluted | 194,901,560 | 163,448,130 |
THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||||
CONSOLIDATED STATEMENTS OF CASH FLOWS | |||||||||
(Unaudited) | |||||||||
Three Months Ended | |||||||||
March 31, 2016 | March 31, 2015 | ||||||||
CASH FLOWS FROM OPERATING ACTIVITIES | |||||||||
Net loss | $ | (20,929,365 | ) | $ | (20,894,256 | ) | |||
Adjustments to reconcile net loss to net cash used in | |||||||||
operating activities: | |||||||||
Depreciation of fixed assets | 8,363 | 6,881 | |||||||
Amortization of intangible assets | 11,234 | 6,691 | |||||||
Provision for doubtful accounts | 236,151 | 13,004 | |||||||
Share-based compensation | 4,381,690 | 840,464 | |||||||
Changes in operating assets and liabilities: | |||||||||
Accounts receivable | (2,250,209 | ) | (502,836 | ) | |||||
Inventory | (267,281 | ) | 222,925 | ||||||
Other current assets | 477,312 | 91,412 | |||||||
Other assets | (2,536 | ) | (9,842 | ) | |||||
Accounts payable | 304,475 | (91,946 | ) | ||||||
Deferred revenue | - | (522,613 | ) | ||||||
Other current liabilities | (1,373,762 | ) | 1,038,813 | ||||||
Other long-term liabilities | - | 651,567 | |||||||
Net cash used in operating activities | (19,403,928 | ) | (19,149,736 | ) | |||||
CASH FLOWS FROM INVESTING ACTIVITIES | |||||||||
Patent costs | (90,529 | ) | (36,853 | ) | |||||
Purchase of fixed assets | (74,478 | ) | - | ||||||
Net cash used in investing activities | (165,007 | ) | (36,853 | ) | |||||
CASH FLOWS FROM FINANCING ACTIVITIES | |||||||||
Proceeds from sale of common stock, net of costs | 134,863,475 | 59,117,827 | |||||||
Proceeds from exercise of options | 786,450 | 7,208 | |||||||
Proceeds from exercise of warrants | 1,310,000 | 358,400 | |||||||
Net cash provided by financing activities | 136,959,925 | 59,483,435 | |||||||
Increase in cash | 117,390,990 | 40,296,846 | |||||||
Cash, beginning of period | 64,706,355 | 51,361,607 | |||||||
Cash, end of period | $ | 182,097,345 | $ | 91,658,453 |
View source version on businesswire.com: http://www.businesswire.com/news/home/20160503006967/en/
Source:
TherapeuticsMD, Inc.
Investors:
Dan Cartwright, 561-961-1900
Chief
Financial Officer
Dan.Cartwright@TherapeuticsMD.com
or
David
Delucia, 561-961-1900
Director of Investor Relations
David.Delucia@TherapeuticsMD.com