– Company to Present additional positive phase 3 data for TX-004HR at the ISSWSH annual meeting –
– Management to host conference call today at
2015 and Recent Developments
-
Net revenue for the company’s prescription prenatal vitamin business
increased to approximately
$20.1 million in 2015 compared with approximately$15.0 million for the prior year. -
Net loss was approximately
$85.1 million in 2015, compared with approximately$54.2 million for the prior year, reflecting investment in two phase 3 clinical trials for the company’s novel hormone therapy drug candidates. -
Reported positive topline data from 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 vaginal
pain during sexual intercourse (dyspareunia), a symptom of vulvar and
vaginal atrophy (VVA) due to menopause. The results showed patients
treated with TX-004HR achieved a statistically significant improvement
over placebo across all four co-primary endpoints at all three doses
evaluated. The validated co-primary endpoint data and additional
secondary endpoint results related to vaginal dryness are scheduled to
be presented this week at the
International Society for the Study of Women’sSexual Health (ISSWSH) Annual Meeting 2016. A summary of these data is included below in this press release. - Exited over 1,400 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.
- The company’s intellectual property portfolio grew to a current total of 122 patent filings, including 72 international filings, with one allowed and 14 issued U.S. patents.
-
Presented two posters at
North American Menopause Society (NAMS) of the company’s transdermal progesterone candidate, TX-005HR, and the company’s transdermal estradiol and progesterone candidate, TX-006HR, demonstrating tissue penetration and target organ activity in a preclinical study. - Strengthened relationships with key medical, pharmacy, patient and industry organizations worldwide.
-
Ended the year with approximately
$64.7 million in cash and no debt, which was further strengthened by an equity offering inJanuary 2016 that generated approximately$135 million of net proceeds to fund commercialization activities for both of the company’s late stage product candidates and other development activities.
“2015 was a breakthrough year for our company, as we reported positive
topline phase 3 data from the Rejoice Trial for TX-004HR, the first of
our two novel pipeline candidates in the women’s health arena,” said
Summary of 2015 Financial Results
For the year ended
Cost of goods sold increased to approximately
Total operating expenses for the fourth quarter and full year 2015
included research and development (R&D) expenses and sales, general and
administrative expenses (SG&A). R&D expenses for the full-year 2015 were
approximately
Non-operating income remained insignificant for the full year 2015 and 2014 and included interest income and other miscellaneous items of income and expense for both periods.
Net loss for the full year 2015 was approximately
At
Phase 3 Data Results Presented at ISSWSH Annual Meeting 2016
Based on the company’s ongoing analyses of the Rejoice Trial data, statistical significance of the results for the co-primary endpoint of severity of participants' self-reported moderate to severe dyspareunia as the most bothersome symptom of VVA has slightly improved for all three doses from the topline results previously reported. The secondary endpoint result for vaginal dryness was also statistically significant for all three doses evaluated in the Rejoice Trial.
Statistical Significance of Results for Co-Primary Endpoints | ||||||
(Based on LS Mean Change from Baseline to Week 12 Compared to Placebo) | ||||||
25 mcg |
10 mcg |
4 mcg | ||||
Superficial Cells |
P < 0.0001 |
P < 0.0001 |
P < 0.0001 |
|||
Parabasal cells |
P < 0.0001 |
P < 0.0001 |
P < 0.0001 |
|||
Vaginal pH |
P < 0.0001 |
P < 0.0001 |
P < 0.0001 |
|||
Severity of Dyspareunia |
P < 0.0001 |
P < 0.0001 |
P = 0.0149 |
|||
Statistical Significance of Results for Secondary Endpoint of Severity of Vaginal Dryness (Based on LS Mean Change from Baseline to Week 12 Compared to Placebo) |
||||||
Severity of Dryness |
P < 0.0001 |
P < 0.0001 |
P = 0.0014 |
|||
LS= Least Squares |
Conference Call Today
As previously announced,
Date: | Thursday, February 25, 2016 | |
Time: | 4:30 p.m. EST | |
Telephone Access (US): | 866-665-9531 | |
Telephone Access (International): | 724-987-6977 | |
Access Code for All Callers: | 45870409 |
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 | |||||||||
December 31, | |||||||||
2015 | 2014 | ||||||||
ASSETS | |||||||||
Current Assets: | |||||||||
Cash | $ | 64,706,355 | $ | 51,361,607 | |||||
Accounts receivable, net of allowance for doubtful accounts | |||||||||
of $81,910 and $59,753, respectively | 3,049,715 | 2,154,217 | |||||||
Inventory | 690,153 | 1,182,113 | |||||||
Other current assets | 2,233,897 | 1,537,407 | |||||||
Total current assets | 70,680,120 | 56,235,344 | |||||||
Fixed assets, net | 198,592 | 63,293 | |||||||
Other Assets: | |||||||||
Intangible assets, net | 1,615,251 | 1,228,588 | |||||||
Prepaid expense | 1,109,883 | 1,427,263 | |||||||
Security deposit | 125,000 | 125,000 | |||||||
Total other assets | 2,850,134 | 2,780,851 | |||||||
Total assets | $ | 73,728,846 | $ | 59,079,488 | |||||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||||
Current Liabilities: | |||||||||
Accounts payable | $ | 3,126,174 | $ | 6,327,129 | |||||
Other current liabilities | 7,539,526 | 3,840,639 | |||||||
Deferred revenue | - | 522,613 | |||||||
Total current liabilities | 10,665,700 | 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; 177,928,041 and 156,097,019 issued | |||||||||
and outstanding, respectively | 177,928 | 156,097 | |||||||
Additional paid-in capital | 282,712,078 | 182,982,846 | |||||||
Accumulated deficit | (219,826,860 | ) | (134,749,836 | ) | |||||
Total stockholders' equity | 63,063,146 | 48,389,107 | |||||||
Total liabilities and stockholders' equity | $ | 73,728,846 | $ | 59,079,488 |
THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||||||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||||||
Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||||||||
2015 | 2014 | 2015 | 2014 | 2013 | |||||||||||||||||
Revenues, net | $ | 5,629,740 | $ | 4,257,647 | $ | 20,142,898 | $ | 15,026,219 | $ | 8,775,598 | |||||||||||
Cost of goods sold | 1,235,978 | 879,535 | 4,506,673 | 3,671,803 | 1,959,597 | ||||||||||||||||
Gross profit | 4,393,762 | 3,378,112 | 15,636,225 | 11,354,416 | 6,816,001 | ||||||||||||||||
Operating expenses: | |||||||||||||||||||||
Sales, general, and administrative | 8,631,238 | 5,514,057 | 28,721,236 | 22,124,072 | 19,014,837 | ||||||||||||||||
Research and development | 13,253,472 | 14,166,789 | 72,042,774 | 43,218,938 | 13,551,263 | ||||||||||||||||
Depreciation and amortization | 18,000 | 12,558 | 62,400 | 52,467 | 58,145 | ||||||||||||||||
Total operating expenses | 21,902,710 | 19,693,404 | 100,826,410 | 65,395,477 | 32,624,245 | ||||||||||||||||
Operating loss | (17,508,948 | ) | (16,315,292 | ) | (85,190,185 | ) | (54,041,061 | ) | (25,808,244 | ) | |||||||||||
Other income and (expenses) | |||||||||||||||||||||
Miscellaneous income, net | 23,991 | 3,158 | 95,719 | 46,569 | 34,544 | ||||||||||||||||
Interest income | 2,280 | 9,553 | 17,442 | 37,309 | 27,234 | ||||||||||||||||
Financing costs |
- |
- |
- |
(260,027 |
) |
(1,503,922 |
) |
||||||||||||||
Interest expense |
- |
- |
- |
- |
(1,165,981 |
) |
|||||||||||||||
Loan guaranty costs |
- |
- |
- |
- |
(2,944 |
) |
|||||||||||||||
Total other income (expense) | 26,271 | 12,711 | 113,161 | (176,149 | ) | (2,611,069 | ) | ||||||||||||||
Loss before income taxes | (17,482,677 | ) | (16,302,581 | ) | (85,077,024 | ) | (54,217,210 | ) | (28,419,313 | ) | |||||||||||
Provision for income taxes | - | - | - | - | - | ||||||||||||||||
Net loss | $ | (17,482,677 | ) | $ | (16,302,581 | ) | $ | (85,077,024 | ) | $ | (54,217,210 | ) | $ | (28,419,313 | ) | ||||||
Loss per share, basic and diluted: | |||||||||||||||||||||
Net loss per share, basic and diluted | $ | (0.10 | ) | $ | (0.10 | ) | $ | (0.49 | ) | $ | (0.36 | ) | $ | (0.22 | ) | ||||||
Weighted average number of common | |||||||||||||||||||||
shares outstanding, basic and diluted | 177,876,462 | 156,054,938 | 173,174,229 | 149,727,228 | 127,569,731 |
THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||||||||
CONSOLIDATED STATEMENTS OF CASH FLOWS | |||||||||||||
Year Ended December, 31, | |||||||||||||
2015 | 2014 | 2013 | |||||||||||
CASH FLOWS FROM OPERATING ACTIVITIES | |||||||||||||
Net loss | $ | (85,077,024 | ) | $ | (54,217,210 | ) | $ | (28,419,313 | ) | ||||
Adjustments to reconcile net loss to net cash used in | |||||||||||||
operating activities: | |||||||||||||
Depreciation | 29,959 | 28,987 | 47,883 | ||||||||||
Amortization of intangible assets | 32,441 | 23,480 | 10,262 | ||||||||||
Provision for (recovery of) doubtful accounts | 22,157 | (5,436 | ) | (15,493 | ) | ||||||||
Amortization of debt discount | - | - | 1,102,680 | ||||||||||
Share-based compensation | 7,189,699 | 4,970,312 | 3,844,155 | ||||||||||
Amortization of deferred financing costs | - | 260,027 | 1,451,934 | ||||||||||
Loan guaranty costs | - | - | 2,944 | ||||||||||
Changes in operating assets and liabilities: | |||||||||||||
Accounts receivable | (917,656 | ) | (458,028 | ) | (1,068,619 | ) | |||||||
Inventory | 491,960 | (138,495 | ) | 571,592 | |||||||||
Other current assets | (773,532 | ) | 680,281 | (1,386,319 | ) | ||||||||
Other assets | (17,442 | ) | (37,309 | ) | (565,706 | ) | |||||||
Accounts payable | (3,200,955 | ) | 4,212,912 | 472,851 | |||||||||
Deferred revenue | (522,613 | ) | (1,079,967 | ) | 457,828 | ||||||||
Other current liabilities | 3,698,887 | 239,450 | 2,875,320 | ||||||||||
Other liabilities | - | - | (150,068 | ) | |||||||||
Net cash used in operating activities | (79,044,119 | ) | (45,520,996 | ) | (20,768,069 | ) | |||||||
CASH FLOWS FROM INVESTING ACTIVITIES | |||||||||||||
Patent costs | (419,104 | ) | (586,480 | ) | (439,034 | ) | |||||||
Purchase of fixed assets | (165,257 | ) | (30,962 | ) | (40,790 | ) | |||||||
Refund (payment) of security deposit | - | 10,686 | (103,737 | ) | |||||||||
Net cash used in investing activities | (584,361 | ) | (606,756 | ) | (583,561 | ) | |||||||
CASH FLOWS FROM FINANCING ACTIVITIES | |||||||||||||
Proceeds from sale of common stock, net of costs | 91,374,649 | 42,771,353 | 78,650,353 | ||||||||||
Proceeds from exercise of options | 1,232,579 | 345,746 | 30,910 | ||||||||||
Proceeds from exercise of warrants | 366,000 | 181,000 | - | ||||||||||
Proceeds bank line of credit | - | - | 500,000 | ||||||||||
Repayment of bank line of credit | - | - | (500,000 | ) | |||||||||
Repayment of notes payable | - | - | (4,691,847 | ) | |||||||||
Net cash provided by financing activities | 92,973,228 | 43,298,099 | 73,989,416 | ||||||||||
Increase (decrease) in cash | 13,344,748 | (2,829,653 | ) | 52,637,786 | |||||||||
Cash, beginning of period | 51,361,607 | 54,191,260 | 1,553,474 | ||||||||||
Cash, end of period | $ | 64,706,355 | $ | 51,361,607 | $ | 54,191,260 | |||||||
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | |||||||||||||
Cash paid for interest | $ | - | $ | - | $ | 212,853 | |||||||
Cash paid for income taxes | $ | - | $ | - | $ | - | |||||||
SUPPLEMENTAL SCHEDULE OF NON-CASH FINANCING ACTIVITIES: | |||||||||||||
Warrants issued for financing | $ | - | $ | - | $ | 1,711,956 | |||||||
Warrants issued for services | $ | - | $ | - | $ | 462,196 |
View source version on businesswire.com: http://www.businesswire.com/news/home/20160225006507/en/
Source:
TherapeuticsMD, Inc.
Investors:
Dan Cartwright, 561-961-1900
Chief
Financial Officer
Dan.Cartwright@TherapeuticsMD.com