First Quarter and Recent Developments
-
Net revenue for the company’s prescription prenatal vitamin business
was approximately
$4.0 million for the first quarter of 2017 compared with approximately$4.9 million for the first quarter of 2016. -
Net loss was approximately
$21.2 million for the first quarter of 2017, compared with approximately$20.9 million for the first quarter of 2016. -
Ended the quarter with approximately
$113.5 million in cash and no debt. -
Anticipate
FDA action on the New Drug Application (NDA) for TX-004HR on or before the originally scheduled Prescription Drug User Fee Act (PDUFA) target action date ofMay 7, 2017 . TX-004HR is 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. -
Presented two posters at
ENDO 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 plans to submit the NDA for TX-001HR as early as the third quarter of 2017. - Launched BIO-IGNITETM, 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. Through the BIO-IGNITETM program, the company currently has a distribution agreement with Premier Value Pharmacy Compounding Network (PVPCN), representing over 300 pharmacies and 1.5 million annual prescriptions of compounded bio-identical estradiol and progesterone (E+P), to dispense the company’s products in lieu of compounding, if approved. The company has also received prescription data from over 400 additional pharmacies, representing over 500,000 annual prescriptions of compounded bio-identical E+P.
- Grew the company’s intellectual property portfolio to a current total of 158 patent filings, including 82 international filings, with one allowed and 17 issued U.S. patents.
“We are focused on advancing our pipeline of novel hormone therapies
and, if approved, bringing new, differentiated treatment options to
women suffering from symptoms of menopause,” said
Summary of First Quarter 2017 Financial Results
Net revenue from the company’s prescription prenatal vitamin business
was approximately
Cost of goods sold was approximately
Total operating expenses for the first quarter of 2017 included research
and development (R&D) expenses and sales, general, and administrative
expenses (SG&A). R&D expenses during the first quarter of 2017 were
approximately
Net loss for the first quarter of 2017 was approximately
At
About
Forward-Looking Statements
This press release by
THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||||
CONSOLIDATED BALANCE SHEETS | |||||||||
March 31, 2017 | December 31, 2016 | ||||||||
(Unaudited) | |||||||||
ASSETS | |||||||||
Current Assets: | |||||||||
Cash | $ | 113,525,419 | $ | 131,534,101 | |||||
Accounts receivable, net of allowance for doubtful accounts of $374,771 and $376,374, respectively |
3,921,359 | 4,500,699 | |||||||
Inventory | 1,338,618 | 1,076,321 | |||||||
Other current assets | 2,488,121 | 2,299,052 | |||||||
Total current assets | 121,273,517 | 139,410,173 | |||||||
Fixed assets, net | 511,073 | 516,839 | |||||||
Other Assets: | |||||||||
Intangible assets, net | 2,497,360 | 2,405,972 | |||||||
Security deposit | 139,036 | 139,036 | |||||||
Total other assets | 2,636,396 | 2,545,008 | |||||||
Total assets | $ | 124,420,986 | $ | 142,472,020 | |||||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||||
Current Liabilities: | |||||||||
Accounts payable | $ | 6,146,278 | $ | 7,358,514 | |||||
Other current liabilities | 7,940,723 | 7,624,085 | |||||||
Total current liabilities | 14,087,001 | 14,982,599 | |||||||
Commitments and Contingencies | |||||||||
Stockholders' Equity: | |||||||||
Preferred stock - par value $0.001; 10,000,000 shares authorized; 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: 198,593,268 and 196,688,222 issued and outstanding, respectively |
198,593 | 196,688 | |||||||
Additional paid-in capital | 441,025,624 | 436,995,052 | |||||||
Accumulated deficit | (330,890,232 | ) | (309,702,319 | ) | |||||
Total stockholders' equity | 110,333,985 | 127,489,421 | |||||||
Total liabilities and stockholders' equity | $ | 124,420,986 | $ | 142,472,020 | |||||
THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||
(Unaudited) | |||||||||
Three Months Ended | |||||||||
March 31, 2017 | March 31, 2016 | ||||||||
Revenues, net | $ | 3,985,464 | $ | 4,930,091 | |||||
Cost of goods sold | 659,635 | 1,108,443 | |||||||
Gross profit | 3,325,829 | 3,821,648 | |||||||
Operating expenses: | |||||||||
Sales, general, and administrative | 16,837,617 | 9,678,552 | |||||||
Research and development | 7,724,840 | 15,097,017 | |||||||
Depreciation and amortization | 49,699 | 19,597 | |||||||
Total operating expenses | 24,612,156 | 24,795,166 | |||||||
Operating loss | (21,286,327 | ) | (20,973,518 | ) | |||||
Other income | |||||||||
Miscellaneous income | 125,968 | 41,617 | |||||||
Accreted interest | 3,867 | 2,536 | |||||||
Total other income | 129,835 | 44,153 | |||||||
Loss before income taxes | (21,156,492 | ) | (20,929,365 | ) | |||||
Provision for income taxes | - | - | |||||||
Net loss | $ | (21,156,492 | ) | $ | (20,929,365 | ) | |||
Loss per share, basic and diluted: | |||||||||
Net loss per share, basic and diluted | $ | (0.11 | ) | $ | (0.11 | ) | |||
Weighted average number of common shares outstanding, basic and diluted |
197,790,040 | 194,901,560 | |||||||
THERAPEUTICSMD, INC. AND SUBSIDIARIES | ||||||||||
CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||||||
(Unaudited) | ||||||||||
Three Months Ended | ||||||||||
March 31, 2017 | March 31, 2016 | |||||||||
CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||||
Net loss | $ | (21,156,492 | ) | $ | (20,929,365 | ) | ||||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||||
Depreciation | 33,600 | 8,363 | ||||||||
Amortization of intangible assets | 16,099 | 11,234 | ||||||||
(Recovery of) provision for doubtful accounts | (1,603 | ) | 236,151 | |||||||
Share-based compensation | 1,413,195 | 4,381,690 | ||||||||
Changes in operating assets and liabilities: | ||||||||||
Accounts receivable | 580,943 | (2,250,209 | ) | |||||||
Inventory | (262,297 | ) | (267,281 | ) | ||||||
Other current assets | (253,518 | ) | 477,312 | |||||||
Other assets | - | (2,536 | ) | |||||||
Accounts payable | (1,212,236 | ) | 304,475 | |||||||
Other current liabilities | 316,638 | (1,373,762 | ) | |||||||
Net cash used in operating activities | (20,525,671 | ) | (19,403,928 | ) | ||||||
CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||||
Patent costs | (107,487 | ) | (90,529 | ) | ||||||
Purchase of fixed assets | (27,834 | ) | (74,478 | ) | ||||||
Net cash used in investing activities | (135,321 | ) | (165,007 | ) | ||||||
CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||||
Proceeds from sale of common stock, net of costs | - | 134,863,475 | ||||||||
Proceeds from exercise of options | 192,310 | 786,450 | ||||||||
Proceeds from exercise of warrants | 2,460,000 | 1,310,000 | ||||||||
Net cash provided by financing activities | 2,652,310 | 136,959,925 | ||||||||
(Decrease) increase in cash | (18,008,682 | ) | 117,390,990 | |||||||
Cash, beginning of period | 131,534,101 | 64,706,355 | ||||||||
Cash, end of period | $ | 113,525,419 | $ | 182,097,345 | ||||||
View source version on businesswire.com: http://www.businesswire.com/news/home/20170502006212/en/
Source:
Investor Contact
TherapeuticsMD,
Inc.
David DeLucia, 561-961-1900
Director, Investor Relations
David.DeLucia@TherapeuticsMD.com
or
Media
Contact
SparkBioComm
Ami Knoefler, 650-739-9952
Ami@SparkBioComm.com