– Pipeline of two late-stage product candidates advancing towards commercialization, with launch of TX-004HR expected in fourth quarter 2017 pending regulatory approval –
– Management to host conference call today at
2016 and Recent Developments
-
Net revenue for the company’s prescription prenatal vitamin business
was approximately
$19.4 million in 2016 compared with approximately$20.1 million for the prior year. -
Net loss was approximately
$89.9 million in 2016, compared with approximately$85.1 million for the prior year, reflecting investment in clinical development for the company’s two phase 3 hormone therapy drug candidates. -
Ended the year with approximately
$131.5 million in cash and no debt. -
Reported positive topline data from the Replenish Trial, a
phase 3 clinical trial of TX-001HR, the company’s 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. Topline results from the trial in 1,835
post-menopausal women demonstrated that multiple doses of TX-001HR
resulted in a statistically significant reduction from baseline
in both the frequency and severity of hot flashes compared to placebo.
In addition, endometrial safety was established with an incidence rate
of endometrial hyperplasia or malignancy of 0% across all doses. The
company plans to submit a New Drug Application (NDA) for TX-001HR to
the
U.S. Food and Drug Administration (FDA ) in the third quarter of 2017. -
Submitted an NDA for TX-004HR, the company’s applicator-free estradiol
vaginal softgel capsule 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 TX-004HR clinical
program, including positive results from all three doses of TX-004HR
(4 mcg, 10 mcg and 25 mcg) that were evaluated in the phase 3 Rejoice
Trial. The FDA’s Prescription Drug User Fee Act (PDUFA) target action
date for the NDA is
May 7, 2017 . - Published three manuscripts with detailed results of the TX-004HR phase 3 Rejoice Trial in the peer-reviewed journal Menopause. The manuscripts review the positive results of TX-004HR across pre-specified co-primary and secondary endpoints in the Rejoice Trial, data from a pharmacokinetic (PK) substudy demonstrating the low systemic absorption of TX-004HR, as well as data from a patient acceptability and satisfaction survey demonstrating a high level of product acceptability, ease of use, and patient satisfaction with TX-004HR.
- The company’s intellectual property portfolio grew to a current total of 144 patent filings, including 74 international filings, with one allowed and 17 issued U.S. patents.
- Strengthened relationships with key medical, pharmacy, patient and industry organizations worldwide. This includes the recent launch of the company’s BIO-IGNITE™ program, an outreach program to quantify the number of compounded bio-identical estradiol and progesterone prescriptions currently dispensed by the 3,000-3,500 high-volume compounding pharmacies and qualify their interests in distributing the company’s bio-identical hormone product candidates, if approved.
“During 2016, we made significant advancements with our two late-stage
pipeline candidates while we pursued our goal to bring new healthcare
solutions to women to help manage their menopause symptoms,” said
Summary of 2016 Financial Results
For the year ended
Total operating expenses for the fourth quarter and full-year 2016
included research and development (R&D) expenses and sales, general and
administrative expenses (SG&A). R&D expenses for the full-year 2016 were
approximately
Net loss for the full-year 2016 was approximately
At
Conference Call Today
As previously announced,
Date: |
Thursday, February 23, 2017 | ||
Time: |
8:00 a.m. EST | ||
Telephone Access (US): |
866-665-9531 | ||
Telephone Access (International): |
724-987-6977 | ||
Access Code for All Callers: |
68412683 | ||
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: 68412683.
About
Forward-Looking Statements
This press release by
THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||||
CONSOLIDATED BALANCE SHEETS | |||||||||
December 31, | |||||||||
2016 | 2015 | ||||||||
ASSETS | |||||||||
Current Assets: | |||||||||
Cash | $ | 131,534,101 | $ | 64,706,355 | |||||
Accounts receivable, net of allowance for doubtful accounts | |||||||||
of $376,374 and $81,910, respectively | 4,500,699 | 3,049,715 | |||||||
Inventory | 1,076,321 | 690,153 | |||||||
Other current assets | 2,299,052 | 2,233,897 | |||||||
Total current assets | 139,410,173 | 70,680,120 | |||||||
Fixed assets, net | 516,839 | 198,592 | |||||||
Other Assets: | |||||||||
Intangible assets, net | 2,405,972 | 1,615,251 | |||||||
Security deposit | 139,036 | 125,000 | |||||||
Prepaid expense | - | 1,109,883 | |||||||
Total other assets | 2,545,008 | 2,850,134 | |||||||
Total assets | $ | 142,472,020 | $ | 73,728,846 | |||||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||||
Current Liabilities: | |||||||||
Accounts payable | $ | 7,358,514 | $ | 3,126,174 | |||||
Other current liabilities | 7,624,085 | 7,539,526 | |||||||
Total current liabilities | 14,982,599 | 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: | |||||||||
196,688,222 and 177,928,041 issued and outstanding, respectively | 196,688 | 177,928 | |||||||
Additional paid-in capital | 436,995,052 | 282,712,078 | |||||||
Accumulated deficit | (309,702,319 | ) | (219,826,860 | ) | |||||
Total stockholders' equity | 127,489,421 | 63,063,146 | |||||||
Total liabilities and stockholders' equity | $ | 142,472,020 | $ | 73,728,846 | |||||
THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||||||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||||||
|
|||||||||||||||||||||
Three Months Ended December 31, |
Year Ended December 31, |
||||||||||||||||||||
2016 | 2015 | 2016 | 2015 | 2014 | |||||||||||||||||
Revenues, net | $ | 4,487,427 | $ | 5,629,740 | $ | 19,356,450 | $ | 20,142,898 | $ | 15,026,219 | |||||||||||
Cost of goods sold | 709,711 | 1,235,978 | 4,185,708 | 4,506,673 | 3,671,803 | ||||||||||||||||
Gross profit | 3,777,716 | 4,393,762 | 15,170,742 | 15,636,225 | 11,354,416 | ||||||||||||||||
Operating expenses: | |||||||||||||||||||||
Sales, general, and administrative | 16,329,146 | 8,631,238 | 51,348,414 | 28,721,236 | 22,124,072 | ||||||||||||||||
Research and development | 10,341,144 | 13,253,472 | 53,943,477 | 72,042,774 | 43,218,938 | ||||||||||||||||
Depreciation and amortization | 48,132 | 18,000 | 132,451 | 62,400 | 52,467 | ||||||||||||||||
Total operating expenses | 26,718,422 | 21,902,710 | 105,424,342 | 100,826,410 | 65,395,477 | ||||||||||||||||
Operating loss | (22,940,706 | ) | (17,508,948 | ) | (90,253,600 | ) | (85,190,185 | ) | (54,041,061 | ) | |||||||||||
Other income and (expense) | |||||||||||||||||||||
Miscellaneous income | 101,438 | 23,991 | 367,317 | 95,719 | 46,569 | ||||||||||||||||
Accreted interest | 2,974 | 2,280 | 10,824 | 17,442 | 37,309 | ||||||||||||||||
Financing costs | - | - | - | - | (260,027 | ) | |||||||||||||||
Total other income (expense) | 104,412 | 26,271 | 378,141 | 113,161 | (176,149 | ) | |||||||||||||||
Loss before income taxes | (22,836,294 | ) | (17,482,677 | ) | (89,875,459 | ) | (85,077,024 | ) | (54,217,210 | ) | |||||||||||
Provision for income taxes | - | - | - | - | - | ||||||||||||||||
Net loss | $ | (22,836,294 | ) | $ | (17,482,677 | ) | $ | (89,875,459 | ) | $ | (85,077,024 | ) | $ | (54,217,210 | ) | ||||||
Loss per share, basic and diluted: | |||||||||||||||||||||
Net loss per share, basic and diluted | $ | (0.12 | ) | $ | (0.10 | ) | $ | (0.46 | ) | $ | (0.49 | ) | $ | (0.36 | ) | ||||||
Weighted average number of common | |||||||||||||||||||||
shares outstanding, basic and diluted | 196,613,297 | 177,876,462 | 196,088,196 | 173,174,229 | 149,727,228 | ||||||||||||||||
THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||||||||
CONSOLIDATED STATEMENTS OF CASH FLOWS | |||||||||||||
Year Ended December, 31, | |||||||||||||
2016 | 2015 | 2014 | |||||||||||
CASH FLOWS FROM OPERATING ACTIVITIES | |||||||||||||
Net loss | $ | (89,875,459 | ) | $ | (85,077,024 | ) | $ | (54,217,210 | ) | ||||
Adjustments to reconcile net loss to net cash used in | |||||||||||||
operating activities: | |||||||||||||
Depreciation | 77,906 | 29,959 | 28,987 | ||||||||||
Amortization of intangible assets | 54,545 | 32,441 | 23,480 | ||||||||||
Provision for (recovery of) doubtful accounts | 2,524,909 | 22,157 | (5,436 | ) | |||||||||
Share-based compensation | 17,411,021 | 7,189,699 | 4,970,312 | ||||||||||
Amortization of deferred financing costs | - | - | 260,027 | ||||||||||
Changes in operating assets and liabilities: | |||||||||||||
Accounts receivable | (3,975,893 | ) | (917,656 | ) | (458,028 | ) | |||||||
Inventory | (386,168 | ) | 491,960 | (138,495 | ) | ||||||||
Other current assets | 709,907 | (773,532 | ) | 680,281 | |||||||||
Other assets | - | (17,442 | ) | (37,309 | ) | ||||||||
Accounts payable | 4,232,340 | (3,200,955 | ) | 4,212,912 | |||||||||
Deferred revenue | - | (522,613 | ) | (1,079,967 | ) | ||||||||
Other current liabilities | 84,559 | 3,698,887 | 239,450 | ||||||||||
Net cash used in operating activities | (69,142,333 | ) | (79,044,119 | ) | (45,520,996 | ) | |||||||
CASH FLOWS FROM INVESTING ACTIVITIES | |||||||||||||
Patent costs | (845,266 | ) | (419,104 | ) | (586,480 | ) | |||||||
Purchase of fixed assets | (396,154 | ) | (165,257 | ) | (30,962 | ) | |||||||
(Payment) refund of security deposit |
(14,036 | ) | - | 10,686 | |||||||||
Net cash used in investing activities | (1,255,456 | ) | (584,361 | ) | (606,756 | ) | |||||||
CASH FLOWS FROM FINANCING ACTIVITIES | |||||||||||||
Proceeds from sale of common stock, net of costs | 134,863,475 | 91,374,649 | 42,771,353 | ||||||||||
Proceeds from exercise of options | 989,060 | 1,232,579 | 345,746 | ||||||||||
Proceeds from exercise of warrants | 1,373,000 | 366,000 | 181,000 | ||||||||||
Net cash provided by financing activities | 137,225,535 | 92,973,228 | 43,298,099 | ||||||||||
Increase (decrease) in cash | 66,827,746 | 13,344,748 | (2,829,653 | ) | |||||||||
Cash, beginning of period | 64,706,355 | 51,361,607 | 54,191,260 | ||||||||||
Cash, end of period | $ | 131,534,101 | $ | 64,706,355 | $ | 51,361,607 |
View source version on businesswire.com: http://www.businesswire.com/news/home/20170223005400/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