- New Drug Application submitted for Yuvvexy™ (TX-004HR) -
- Topline phase 3 data for TX-001HR Replenish Trial on track for fourth quarter of 2016 -
Second Quarter and Recent Developments
-
Submitted a New Drug Application (NDA) with the
U.S. Food and Drug Administration for Yuvvexy, the conditionally approved trade name for TX-004HR, the company’s 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 NDA is supported by the complete Yuvvexy clinical program, including positive results of the recently completed phase 3 Rejoice Trial. The submission included all three doses of Yuvvexy (4 mcg, 10 mcg and 25 mcg) that were evaluated in the Rejoice Trial. -
Net revenue from the company’s prescription prenatal vitamin business
was approximately
$4.4 million for the second quarter of 2016, compared with approximately$4.8 million for the second quarter of 2015. -
Net loss was approximately
$21.1 million for the second quarter of 2016, compared with approximately$27.2 million for the second quarter of 2015. -
Ended the quarter with approximately
$166.5 million in cash and no debt. -
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. Approximately 1,642 patients have already exited the trial. -
Presented posters on the positive results of the phase 3 Rejoice Trial
for Yuvvexy at major medical conferences, including the
Endocrine Society annual meeting (ENDO 2016) and theAmerican College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting. - Launched innovative new compliance packaging for vitaMedMD’s vitaPearl™ prenatal multivitamin and BocaGreen’s Prena1 Pearl, the brand’s authorized generic.
- Grew the company’s intellectual property portfolio to a current total of 135 patent filings, including 72 international filings, with 17 issued U.S. patents.
-
Strengthened relationships with medical, pharmacy, patient and
industry organizations worldwide, including ongoing activity with the
leadership of the
International Association of Compounding Pharmacists .
“The second quarter was transformative for our company, with the
submission of our NDA for Yuvvexy as a highly-differentiated potential
treatment for moderate to severe dyspareunia, a symptom of VVA, due to
menopause,” said
Summary of Second Quarter 2016 Financial Results
For the quarter ended
Cost of goods sold was approximately
Total operating expenses for the second quarter of 2016 included
research and development (R&D) expenses and sales, general and
administrative expenses (SG&A). R&D expenses during the second quarter
of 2016 were approximately
Net loss for the second quarter of 2016 was approximately
At
Conference Call Today
As previously announced,
Date: |
Thursday, August 4, 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: 46530545.
About
This press release by
THERAPEUTICSMD, INC. AND SUBSIDIARIES | ||||||
CONSOLIDATED BALANCE SHEETS | ||||||
June 30, 2016 | December 31, 2015 | |||||
(Unaudited) | ||||||
ASSETS | ||||||
Current Assets: |
||||||
Cash | $ | 166,532,446 | $ | 64,706,355 | ||
Accounts receivable, net of allowance for doubtful accounts |
||||||
of $529,298 and $81,910, respectively |
4,477,308 | 3,049,715 | ||||
Inventory | 883,656 | 690,153 | ||||
Other current assets | 2,136,735 | 2,233,897 | ||||
Total current assets | 174,030,145 | 70,680,120 | ||||
Fixed assets, net | 444,412 | 198,592 | ||||
Other Assets: | ||||||
Intangible assets, net | 1,983,829 | 1,615,251 | ||||
Prepaid expense | - | 1,109,883 | ||||
Security deposit | 129,864 | 125,000 | ||||
Total other assets | 2,113,693 | 2,850,134 | ||||
Total assets | $ | 176,588,250 | $ | 73,728,846 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||
Current Liabilities: | ||||||
Accounts payable | $ | 3,039,388 | $ | 3,126,174 | ||
Other current liabilities | 6,299,783 | 7,539,526 | ||||
Total current liabilities | 9,339,171 | 10,665,700 | ||||
Total liabilities | 9,339,171 | 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; | ||||||
196,492,195 and 177,928,041 issued and outstanding, respectively | 196,492 | 177,928 | ||||
Additional paid in capital | 428,902,951 | 282,712,078 | ||||
Accumulated deficit | (261,850,364) | (219,826,860) | ||||
Total stockholders' equity | 167,249,079 | 63,063,146 | ||||
Total liabilities and stockholders' equity | $ | 176,588,250 | $ | 73,728,846 |
THERAPEUTICSMD, INC. AND SUBSIDIARIES | ||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||
(Unaudited) | ||||||||||||
Three Months Ended | Six Months Ended | |||||||||||
June 30, | June 30, | |||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||
Revenues, net | $ | 4,403,247 | $ | 4,847,934 | $ | 9,333,338 | $ | 9,322,983 | ||||
Cost of goods sold | 1,130,108 | 1,033,089 | 2,238,551 | 2,076,730 | ||||||||
Gross profit | 3,273,139 | 3,814,845 | 7,094,787 | 7,246,253 | ||||||||
Operating expenses: | ||||||||||||
Sales, general, and administration | 10,619,006 | 6,865,442 | 20,297,558 | 13,029,054 | ||||||||
Research and development | 13,841,193 | 24,190,714 | 28,938,210 | 42,367,549 | ||||||||
Depreciation and amortization | 24,262 | 14,280 | 43,859 | 27,852 | ||||||||
Total operating expense | 24,484,461 | 31,070,436 | 49,279,627 | 55,424,455 | ||||||||
Operating loss | (21,211,322) | (27,255,591) | (42,184,840) | (48,178,202) | ||||||||
Other income: | ||||||||||||
Miscellaneous income | 114,320 | 25,585 | 155,937 | 44,098 | ||||||||
Accreted interest | 2,863 | 2,560 | 5,399 | 12,402 | ||||||||
Total other income | 117,183 | 28,145 | 161,336 | 56,500 | ||||||||
Loss before taxes | (21,094,139) | (27,227,446) | (42,023,504) | (48,121,702) | ||||||||
Provision for income taxes | - | - | - | - | ||||||||
Net loss | $ | (21,094,139) | $ | (27,227,446) | $ | (42,023,504) | $ | (48,121,702) | ||||
Net loss per share, basic and diluted | $ | (0.11) | $ | (0.16) | $ | (0.21) | $ | (0.29) | ||||
Weighted average number of common | ||||||||||||
shares outstanding | 196,325,715 | 172,782,264 | 195,613,639 | 168,734,760 |
THERAPEUTICSMD, INC. AND SUBSIDIARIES | ||||||
CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||
(Unaudited) | ||||||
Six Months Ended | ||||||
June 30, 2016 | June 30, 2015 | |||||
CASH FLOWS FROM OPERATING ACTIVITIES | ||||||
Net loss | $ | (42,023,504) | $ | (48,121,702) | ||
Adjustments to reconcile net loss to net cash flows used in | ||||||
operating activities: | ||||||
Depreciation of fixed assets | 19,216 | 14,248 | ||||
Amortization of intangible assets | 24,643 | 13,604 | ||||
Provision for doubtful accounts | 447,388 | 30,767 | ||||
Share-based compensation | 9,200,844 | 2,968,811 | ||||
Changes in operating assets and liabilities: | ||||||
Accounts receivable | (1,874,980) | (1,190,068) | ||||
Inventory | (193,503) | (66,606) | ||||
Other current assets | 1,001,120 | 383,194 | ||||
Other assets | - | (12,410) | ||||
Accounts payable | (86,786) | (508,511) | ||||
Deferred revenue | - | (522,613) | ||||
Other current liabilities | (1,239,743) | 2,047,264 | ||||
Other long-term liabilities | - | 967,286 | ||||
Net cash used in operating activities | (34,725,305) | (43,996,736) | ||||
CASH FLOWS FROM INVESTING ACTIVITIES | ||||||
Patent costs | (393,221) | (78,792) | ||||
Purchase of fixed assets | (265,036) | (15,559) | ||||
Payment of security deposit | (4,864) | - | ||||
Net cash used in investing activities | (663,121) | (94,351) | ||||
CASH FLOWS FROM FINANCING ACTIVITIES | ||||||
Proceeds from sale of common stock, net of costs | 134,863,475 | 59,117,827 | ||||
Proceeds from exercise of warrants | 1,373,000 | 366,000 | ||||
Proceeds from exercise of options | 978,042 | 491,351 | ||||
Net cash provided by financing activities | 137,214,517 | 59,975,178 | ||||
Increase in cash | 101,826,091 | 15,884,091 | ||||
Cash, beginning of period | 64,706,355 | 51,361,607 | ||||
Cash, end of period | $ | 166,532,446 | $ | 67,245,698 |
View source version on businesswire.com: http://www.businesswire.com/news/home/20160804006363/en/
Source:
TherapeuticsMD, Inc.
Investors:
David DeLucia, 561-961-1900
Director,
Investor Relations
David.DeLucia@TherapeuticsMD.com