Second Quarter and Recent Developments
-
Net revenue for the company’s prescription prenatal vitamin business
was approximately
$4.3 million for the second quarter of 2017 compared with approximately$4.4 million for the second quarter of 2016. -
Net loss was approximately
$19.7 million for the second quarter of 2017, compared with approximately$21.1 million for the second quarter of 2016. -
Ended the quarter with approximately
$96.5 million in cash and no debt. -
Participated in a Type A Post-Action Meeting on
June 14, 2017 with theDivision of Bone , Reproductive, and Urologic Products (DBRUP) of theFDA to discuss the Complete Response Letter (CRL) regarding 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. The Company has formally submitted additional information for consideration related to the NDA for TX-004HR and has been informed by theFDA that it will be receiving an Advice Letter within the next week outlining the FDA’s timing of its review of the submitted additional data. -
Pre-NDA meeting for 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, scheduled with
the
FDA at the end ofAugust 2017 . The company anticipates that it will submit the NDA for TX-001HR in the fourth quarter of 2017. - Dismissal without prejudice of the primary federal securities class action lawsuit recently filed against the company.
- 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 continue to focus 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 Second 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 second quarter of 2017 included
research and development (R&D) expenses and sales, general, and
administrative expenses (SG&A). R&D expenses for the second quarter of
2017 were approximately
Net loss for the second quarter of 2017 was approximately
At
About
Forward-Looking Statements
This press release by
THERAPEUTICSMD, INC. AND SUBSIDIARIES |
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CONSOLIDATED BALANCE SHEETS |
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(Unaudited) |
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June 30, 2017 | December 31, 2016 | |||||||
ASSETS | ||||||||
Current Assets: | ||||||||
Cash | $ | 96,476,483 | $ | 131,534,101 | ||||
Accounts receivable, net of allowance for doubtful accounts | ||||||||
of $358,268 and $376,374, respectively | 3,396,419 | 4,500,699 | ||||||
Inventory | 1,414,015 | 1,076,321 | ||||||
Other current assets | 2,228,755 | 2,299,052 | ||||||
Total current assets | 103,515,672 | 139,410,173 | ||||||
Fixed assets, net | 483,688 | 516,839 | ||||||
Other Assets: | ||||||||
Intangible assets, net | 2,739,686 | 2,405,972 | ||||||
Security deposit | 139,036 | 139,036 | ||||||
Total other assets | 2,878,722 | 2,545,008 | ||||||
Total assets | $ | 106,878,082 | $ | 142,472,020 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
Current Liabilities: | ||||||||
Accounts payable | $ | 8,108,034 | $ | 7,358,514 | ||||
Other current liabilities | 5,180,218 | 7,624,085 | ||||||
Total current liabilities | 13,288,252 | 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; | ||||||||
204,027,142 and 196,688,222 issued and outstanding, respectively | 204,027 | 196,688 | ||||||
Additional paid in capital | 443,952,952 | 436,995,052 | ||||||
Accumulated deficit | (350,567,149 | ) | (309,702,319 | ) | ||||
Total stockholders' equity | 93,589,830 | 127,489,421 | ||||||
Total liabilities and stockholders' equity | $ | 106,878,082 | $ | 142,472,020 | ||||
THERAPEUTICSMD, INC. AND SUBSIDIARIES |
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CONSOLIDATED STATEMENTS OF OPERATIONS |
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(Unaudited) |
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Three Months Ended | Six Months Ended | ||||||||||||||||||
June 30, | June 30, | ||||||||||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||||||||||
Revenues, net | $ | 4,250,433 | $ | 4,403,247 | $ | 8,235,897 | $ | 9,333,338 | |||||||||||
Cost of goods sold | 681,725 | 1,130,108 | 1,341,360 | 2,238,551 | |||||||||||||||
Gross profit | 3,568,708 | 3,273,139 | 6,894,537 | 7,094,787 | |||||||||||||||
Operating expenses: | |||||||||||||||||||
Sales, general, and administration | 14,628,927 | 10,619,006 | 31,466,544 | 20,297,558 | |||||||||||||||
Research and development | 8,716,395 | 13,841,193 | 16,441,235 | 28,938,210 | |||||||||||||||
Depreciation and amortization | 53,189 | 24,262 | 102,888 | 43,859 | |||||||||||||||
Total operating expense | 23,398,511 | 24,484,461 | 48,010,667 | 49,279,627 | |||||||||||||||
Operating loss | (19,829,803 | ) | (21,211,322 | ) | (41,116,130 | ) | (42,184,840 | ) | |||||||||||
Other income: | |||||||||||||||||||
Miscellaneous income | 149,054 | 114,320 | 275,022 | 155,937 | |||||||||||||||
Accreted interest | 3,832 | 2,863 | 7,699 | 5,399 | |||||||||||||||
Total other income | 152,886 | 117,183 | 282,721 | 161,336 | |||||||||||||||
Loss before taxes | (19,676,917 | ) | (21,094,139 | ) | (40,833,409 | ) | (42,023,504 | ) | |||||||||||
Provision for income taxes | - | - | - | - | |||||||||||||||
Net loss | $ | (19,676,917 | ) | $ | (21,094,139 | ) | $ | (40,833,409 | ) | $ | (42,023,504 | ) | |||||||
Net loss per share, basic and diluted | $ | (0.10 | ) | $ | (0.11 | ) | $ | (0.20 | ) | $ | (0.21 | ) | |||||||
Weighted average number of common | |||||||||||||||||||
shares outstanding | 203,384,610 | 196,325,715 | 200,602,778 | 195,613,639 | |||||||||||||||
THERAPEUTICSMD, INC. AND SUBSIDIARIES |
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CONSOLIDATED STATEMENTS OF CASH FLOWS |
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(Unaudited) |
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Six Months Ended | ||||||||||
June 30, 2017 | June 30, 2016 | |||||||||
CASH FLOWS FROM OPERATING ACTIVITIES |
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Net loss | $ | (40,833,409 | ) | $ | (42,023,504 | ) | ||||
Adjustments to reconcile net loss to net cash flows used in operating activities: |
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Depreciation of fixed assets | 69,000 | 19,216 | ||||||||
Amortization of intangible assets | 33,888 | 24,643 | ||||||||
(Recovery of) provision for doubtful accounts | (18,106 | ) | 447,388 | |||||||
Share-based compensation | 3,051,357 | 9,200,844 | ||||||||
Changes in operating assets and liabilities: | ||||||||||
Accounts receivable | 1,122,386 | (1,874,980 | ) | |||||||
Inventory | (337,694 | ) | (193,503 | ) | ||||||
Other current assets | (58,601 | ) | 1,001,120 | |||||||
Accounts payable | 749,520 | (86,786 | ) | |||||||
Other current liabilities | (2,443,867 | ) | (1,239,743 | ) | ||||||
Net cash used in operating activities | (38,665,526 | ) | (34,725,305 | ) | ||||||
CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||||
Patent costs | (367,602 | ) | (393,221 | ) | ||||||
Purchase of fixed assets | (35,849 | ) | (265,036 | ) | ||||||
Payment of security deposit | - | (4,864 | ) | |||||||
Net cash used in investing activities | (403,451 | ) | (663,121 | ) | ||||||
CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||||
Proceeds from sale of common stock, net of costs | - | 134,863,475 | ||||||||
Proceeds from exercise of warrants | 3,798,999 | 1,373,000 | ||||||||
Proceeds from exercise of options | 212,360 | 978,042 | ||||||||
Net cash provided by financing activities | 4,011,359 | 137,214,517 | ||||||||
(Decrease) increase in cash | (35,057,618 | ) | 101,826,091 | |||||||
Cash, beginning of period | 131,534,101 | 64,706,355 | ||||||||
Cash, end of period | $ | 96,476,483 | $ | 166,532,446 | ||||||
View source version on businesswire.com: http://www.businesswire.com/news/home/20170803006008/en/
Source:
TherapeuticsMD, Inc.
David DeLucia, 561-961-1900
Director,
Investor Relations
David.DeLucia@TherapeuticsMD.com