- PDUFA target action date of
- Acceptance of New Drug Application for TX-001HR expected in
2017 and Recent Developments
-
Resubmitted the New Drug Application (NDA) for TX-004HR, 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, on
November 29, 2017 .The Food and Drug Administration (FDA ) has acknowledged that the resubmission is a complete, class 2 response to the Complete Response Letter (CRL) received onMay 5, 2017 for TX-004HR. The PDUFA target action date for the completion of theFDA's review of the NDA isMay 29, 2018 . -
Presented five oral abstracts at NAMS 2017 reviewing data from the
Replenish Trial, a phase 3 clinical trial of TX-001HR, the company’s
investigational bio-identical hormone therapy combination of estradiol
and progesterone in a single, oral softgel for the treatment of
moderate-to-severe vasomotor symptoms due to menopause. The results
from the trial in 1,835 postmenopausal women demonstrated that
multiple doses of TX-001HR resulted in a statistically significant and
clinically meaningful reduction from baseline in both the frequency
and severity of hot flashes compared to placebo. The Company submitted
the NDA for TX-001HR on
December 28, 2017 . -
Net revenue for the company’s prescription prenatal vitamin business
was approximately
$16.8 million for 2017 compared with approximately$19.4 million for 2016. -
Net loss was approximately
$76.9 million for 2017, compared with approximately$89.9 million for 2016. -
Ended the year with approximately
$127.1 million in cash and no debt, which includes approximately$68.6 million in net proceeds from an equity offering inSeptember 2017 . - Grew the company’s intellectual property portfolio to a current total of 211 patent filings, including 123 international filings, with one allowed and 18 issued U.S. patents.
“Our company has tremendous opportunity in 2018,” said
Summary of 2017 Financial Results
For the year ended
Total operating expenses for the fourth quarter and full-year 2017
included research and development (R&D) expenses and sales, general and
administrative expenses (SG&A). R&D expenses for the full-year 2017 were
approximately
Net loss for the full-year 2017 was approximately
At
Conference Call Today
As previously announced,
Date: |
Tuesday, February 20, 2018 | |
Time: |
4:30 p.m. EST | |
Telephone Access (US): |
866-665-9531 | |
Telephone Access (International): |
724-987-6977 | |
Access Code for All Callers: |
3789163 |
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: 3789163.
About
Forward-Looking Statements
This press release by
THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||||
CONSOLIDATED BALANCE SHEETS | |||||||||
December 31, | |||||||||
2017 | 2016 | ||||||||
ASSETS | |||||||||
Current Assets: | |||||||||
Cash | $ | 127,135,628 | $ | 131,534,101 | |||||
Accounts receivable, net of allowance for doubtful accounts | |||||||||
of $380,580 and $376,374, respectively | 4,328,802 | 4,500,699 | |||||||
Inventory | 1,485,358 | 1,076,321 | |||||||
Other current assets | 6,604,284 | 2,299,052 | |||||||
Total current assets | 139,554,072 | 139,410,173 | |||||||
Fixed assets, net | 437,055 | 516,839 | |||||||
Other Assets: | |||||||||
Intangible assets, net | 3,099,747 | 2,405,972 | |||||||
Security deposit | 139,036 | 139,036 | |||||||
Total other assets | 3,238,783 | 2,545,008 | |||||||
Total assets | $ | 143,229,910 | $ | 142,472,020 | |||||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||||
Current Liabilities: | |||||||||
Accounts payable | $ | 4,097,600 | $ | 7,358,514 | |||||
Other current liabilities | 9,223,595 | 7,624,085 | |||||||
Total current liabilities | 13,321,195 | 14,982,599 | |||||||
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: | |||||||||
216,429,642 and 196,688,222 issued and outstanding, respectively | 216,430 | 196,688 | |||||||
Additional paid-in capital | 516,351,405 | 436,995,052 | |||||||
Accumulated deficit | (386,659,120 | ) | (309,702,319 | ) | |||||
Total stockholders' equity | 129,908,715 | 127,489,421 | |||||||
Total liabilities and stockholders' equity | $ | 143,229,910 | $ | 142,472,020 |
THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||||||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||||||
|
|||||||||||||||||||||
Three Months Ended December 31, |
Year Ended December 31, |
||||||||||||||||||||
2017 | 2016 | 2017 | 2016 | 2015 | |||||||||||||||||
Revenues, net | $ | 4,124,218 | $ | 4,487,427 | $ | 16,777,713 | $ | 19,356,450 | $ | 20,142,898 | |||||||||||
Cost of goods sold | 594,769 | 709,711 | 2,636,943 | 4,185,708 | 4,506,673 | ||||||||||||||||
Gross profit | 3,529,449 | 3,777,716 | 14,140,770 | 15,170,742 | 15,636,225 | ||||||||||||||||
Operating expenses: | |||||||||||||||||||||
Sales, general, and administrative | 14,178,958 | 16,329,146 | 57,703,370 | 51,348,414 | 28,721,236 | ||||||||||||||||
Research and development | 10,974,956 | 10,341,144 | 33,852,993 | 53,943,477 | 72,042,774 | ||||||||||||||||
Depreciation and amortization | 56,174 | 48,132 | 213,117 | 132,451 | 62,400 | ||||||||||||||||
Total operating expenses | 25,210,088 | 26,718,422 | 91,769,480 | 105,424,342 | 100,826,410 | ||||||||||||||||
Operating loss | (21,680,639 | ) | (22,940,706 | ) | (77,628,710 | ) | (90,253,600 | ) | (85,190,185 | ) | |||||||||||
Other income | |||||||||||||||||||||
Miscellaneous income | 253,309 | 101,438 | 695,631 | 367,317 | 95,719 | ||||||||||||||||
Accreted interest | - | 2,974 | 7,699 | 10,824 | 17,442 | ||||||||||||||||
Total other income | 253,309 | 104,412 | 703,330 | 378,141 | 113,161 | ||||||||||||||||
Loss before income taxes | (21,427,330 | ) | (22,836,294 | ) | (76,925,380 | ) | (89,875,459 | ) | (85,077,024 | ) | |||||||||||
Provision for income taxes | - | - | - | - | - | ||||||||||||||||
Net loss | $ | (21,427,330 | ) | $ | (22,836,294 | ) | $ | (76,925,380 | ) | $ | (89,875,459 | ) | $ | (85,077,024 | ) | ||||||
Loss per share, basic and diluted: | |||||||||||||||||||||
Net loss per share, basic and diluted | $ | (0.10 | ) | $ | (0.12 | ) | $ | (0.37 | ) | $ | (0.46 | ) | $ | (0.49 | ) | ||||||
Weighted average number of common | |||||||||||||||||||||
shares outstanding, basic and diluted | 216,429,642 | 196,613,297 | 205,523,288 | 196,088,196 | 173,174,229 |
THERAPEUTICSMD, INC. AND SUBSIDIARIES | ||||||||||||||||||
CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||||||||||||||
Year Ended December, 31, | ||||||||||||||||||
2017 | 2016 | 2015 | ||||||||||||||||
CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||||||||||||
Net loss | $ | (76,925,380 | ) | $ | (89,875,459 | ) | $ | (85,077,024 | ) | |||||||||
Adjustments to reconcile net loss to net cash used in | ||||||||||||||||||
operating activities: | ||||||||||||||||||
Depreciation | 141,601 | 77,906 | 29,959 | |||||||||||||||
Amortization of intangible assets | 71,516 | 54,545 | 32,441 | |||||||||||||||
Provision for doubtful accounts | 4,206 | 2,524,909 | 22,157 | |||||||||||||||
Share-based compensation | 6,889,323 | 17,411,021 | 7,189,699 | |||||||||||||||
Changes in operating assets and liabilities: | ||||||||||||||||||
Accounts receivable | 167,691 | (3,975,893 | ) | (917,656 | ) | |||||||||||||
Inventory | (409,037 | ) | (386,168 | ) | 491,960 | |||||||||||||
Other current assets | (4,434,130 | ) | 709,907 | (773,532 | ) | |||||||||||||
Other assets | - | - | (17,442 | ) | ||||||||||||||
Accounts payable | (3,260,914 | ) | 4,232,340 | (3,200,955 | ) | |||||||||||||
Deferred revenue | - | - | (522,613 | ) | ||||||||||||||
Other current liabilities | 1,599,510 | 84,559 | 3,698,887 | |||||||||||||||
Net cash used in operating activities | (76,155,614 | ) | (69,142,333 | ) | (79,044,119 | ) | ||||||||||||
CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||||||||||||
Patent costs | (765,291 | ) | (845,266 | ) | (419,104 | ) | ||||||||||||
Purchase of fixed assets | (61,817 | ) | (396,154 | ) | (165,257 | ) | ||||||||||||
Payment of security deposit | - | (14,036 | ) | - | ||||||||||||||
Net cash used in investing activities | (827,108 | ) | (1,255,456 | ) | (584,361 | ) | ||||||||||||
CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||||||||||||
Proceeds from sale of common stock, net of costs | 68,572,635 | 134,863,475 | 91,374,649 | |||||||||||||||
Proceeds from exercise of options | 212,615 | 989,060 | 1,232,579 | |||||||||||||||
Proceeds from exercise of warrants | 3,798,999 | 1,373,000 | 366,000 | |||||||||||||||
Net cash provided by financing activities | 72,584,249 | 137,225,535 | 92,973,228 | |||||||||||||||
(Decrease) increase in cash | (4,398,473 | ) | 66,827,746 | 13,344,748 | ||||||||||||||
Cash, beginning of period | 131,534,101 | 64,706,355 | 51,361,607 | |||||||||||||||
Cash, end of period | $ | 127,135,628 | $ | 131,534,101 | $ | 64,706,355 |
View source version on businesswire.com: http://www.businesswire.com/news/home/20180220006522/en/
Source:
TherapeuticsMD, Inc.
Investor Contact
David
DeLucia, 561-961-1900
Director, Investor Relations
David.DeLucia@TherapeuticsMD.com