Full Press Release Details
TherapeuticsMD, Inc. - 8-K
TherapeuticsMD Announces Third Quarter 2016
- Topline phase 3 data for TX-001HR Replenish
Trial on track for fourth quarter of 2016 -
- TX-004HR PDUFA target action date of May
RATON, Fla. - Nov. 3, 2016 - TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women's healthcare
company, today announced its third quarter financial results for the quarter ended September 30, 2016.
Third Quarter and Recent Developments
"We are making excellent progress this
year advancing our pipeline and enhancing our commercial capabilities focused on women's health. During the quarter, we successfully
completed the submission of our NDA for TX-004HR as a novel treatment for moderate to severe dyspareunia, a symptom of VVA due
to menopause, and we continued ongoing pre-commercialization activities for this important product," said TherapeuticsMD
CEO Robert G. Finizio. "We now eagerly await the topline data from our Replenish Trial for TX-001HR in the fourth quarter
of 2016, our second novel hormone therapy program, which, if approved, would be the first and only FDA-approved bio-identical combination
of estradiol and progesterone for the treatment of moderate-to-severe vasomotor symptoms due to menopause."
Summary of Third Quarter 2016 Financial Results
Net revenue from the company's prescription
prenatal vitamins increased 7 percent to approximately $5.5 million for the third quarter of 2016 from approximately $5.2 million
for the prior year's quarter.
Cost of goods sold was approximately $1.2 million
for the third quarter of both 2016 and 2015.
Total operating expenses for the third quarter
of 2016 included research and development (R&D) expenses and sales, general and administrative expenses (SG&A). R&D
expenses during the third quarter of 2016 were approximately $14.7 million compared to approximately $16.4 million during the prior
year's quarter, reflecting a decline in the company's clinical trial costs. SG&A expenses for the third quarter
of 2016 were approximately $14.7 million compared with approximately $7.1 million for the prior year's quarter. Higher SG&A
expenses during the third quarter of 2016 were primarily due to an increase in the company's sales, marketing and regulatory
personnel to support future commercialization of the company's pipeline products.
Net loss for the third quarter of 2016 was
approximately $25.0 million, or $0.13 per basic and diluted share, compared with approximately $19.5 million, or $0.11 per basic
and diluted share, for the third quarter of 2015.
At September 30, 2016, cash on hand was approximately
$147.5 million, compared with approximately $64.7 million at December 31, 2015.
Conference Call Today
As previously announced, TherapeuticsMD will
host a conference call today to discuss these financial results and provide a business update. Details for the call are:
| Date: | Thursday, November 3, 2016 |
| Time: | 4:30 p.m. EDT |
| Telephone Access (US): | 866-665-9531 |
| Telephone Access (International): | 724-987-6977 |
| Access Code for All Callers: | 99198056 |
Additionally, a live webcast can be accessed
on the company's website, www.therapeuticsmd.com, in 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: 99198056.
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is an innovative healthcare
company focused on developing and commercializing products exclusively for women. With its SYMBODA technology, TherapeuticsMD
is developing advanced hormone therapy pharmaceutical products to enable delivery of bio-identical hormones through a variety
of dosage forms and administration routes. The company's clinical development pipeline includes two phase 3 products. The
company also manufactures and distributes branded and generic prescription prenatal vitamins as well as over-the-counter vitamins
under the vitaMedMD and BocaGreenMD brands. More information is available at the following websites:
and www.bocagreenmd.com.
Forward-Looking Statements
This press release by TherapeuticsMD, Inc.
may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to
TherapeuticsMD's objectives, plans and strategies as well as statements, other than historical facts, that address activities,
events or developments that the company intends, expects, projects, believes or anticipates will or may occur in the future. These
statements are often characterized by terminology such as "believes," "hopes," "may," "anticipates,"
"should," "intends," "plans," "will," "expects," "estimates,"
"projects," "positioned," "strategy" and similar expressions and are based on assumptions
and assessments made in light of management's experience and perception of historical trends, current conditions, expected
future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as
of the date of this press release, and the company undertakes no duty to update or revise any such statements, whether as a result
of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject
to risks and uncertainties, many of which are outside of the company's control. Important factors that could cause actual
results, developments and business decisions to differ materially from forward-looking statements are described in the sections
titled "Risk Factors" in the company's filings with the Securities and Exchange Commission, including its most
recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as reports on Form 8-K, and include the following:
the company's ability to maintain or increase sales of its products; the company's ability to develop and commercialize
its hormone therapy drug candidates and obtain additional financing necessary therefor; whether the FDA will approve the company's
new drug application for its TX-004HR product candidate and whether any such approval will occur by the PDUFA date; the length,
cost and uncertain results of the company's clinical trials; the potential of adverse side effects or other safety risks
that could preclude the approval of the company's hormone therapy drug candidates; the company's reliance on third
parties to conduct its clinical trials, research and development and manufacturing; the availability of reimbursement from government
authorities and health insurance companies for the company's products; the impact of product liability lawsuits; the influence
of extensive and costly government regulation; the volatility of the trading price of the company's common stock and the
concentration of power in its stock ownership. PDF copies of the company's historical press releases and financial tables
can be viewed and downloaded at its website: www.therapeuticsmd.com/pressreleases.aspx.
Director, Investor Relations
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
| September 30, 2016 | December 31, 2015 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash | $ | 147,534,065 | $ | 64,706,355 | ||||
| Accounts receivable, net of allowance for doubtful accounts | ||||||||
| of $113,034 and $81,910, respectively | 5,033,298 | 3,049,715 | ||||||
| Inventory | 843,398 | 690,153 | ||||||
| Other current assets | 2,693,475 | 2,233,897 | ||||||
| Total current assets | 156,104,236 | 70,680,120 | ||||||
| Fixed assets, net | 460,546 | 198,592 | ||||||
| Other Assets: | ||||||||
| Intangible assets, net | 2,118,378 | 1,615,251 | ||||||
| Prepaid expense | - | 1,109,883 | ||||||
| Security deposit | 139,036 | 125,000 | ||||||
| Total other assets | 2,257,414 | 2,850,134 | ||||||
| Total assets | $ | 158,822,196 | $ | 73,728,846 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 4,224,419 | $ | 3,126,174 | ||||
| Other current liabilities | 8,243,421 | 7,539,526 | ||||||
| Total current liabilities | 12,467,840 | 10,665,700 | ||||||
| Total liabilities | 12,467,840 | 10,665,700 | ||||||
| Commitments and Contingencies - See Note 15 | ||||||||
| 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; | ||||||||
| 196,580,212 and 177,928,041 issued and outstanding, respectively | 196,580 | 177,928 | ||||||
| Additional paid in capital | 433,023,801 | 282,712,078 | ||||||
| Accumulated deficit | (286,866,025 | ) | (219,826,860 | ) | ||||
| Total stockholders' equity | 146,354,356 | 63,063,146 | ||||||
| Total liabilities and stockholders' equity | $ | 158,822,196 | $ | 73,728,846 |
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Revenues, net | $ | 5,535,685 | $ | 5,190,175 | $ | 14,869,023 | $ | 14,513,158 | ||||||||
| Cost of goods sold | 1,237,446 | 1,193,965 | 3,475,997 | 3,270,695 | ||||||||||||
| Gross profit | 4,298,239 | 3,996,210 | 11,393,026 | 11,242,463 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Sales, general, and administration | 14,721,710 | 7,060,944 | 35,019,268 | 20,089,998 | ||||||||||||
| Research and development | 14,664,123 | 16,421,753 | 43,602,333 | 58,789,302 | ||||||||||||
| Depreciation and amortization | 40,460 | 16,548 | 84,319 | 44,400 | ||||||||||||
| Total operating expense | 29,426,293 | 23,499,245 | 78,705,920 | 78,923,700 | ||||||||||||
| Operating loss | (25,128,054 | ) | (19,503,035 | ) | (67,312,894 | ) | (67,681,237 | ) | ||||||||
| Other income: | ||||||||||||||||
| Miscellaneous income | 109,942 | 27,630 | 265,879 | 71,728 | ||||||||||||
| Accreted interest | 2,451 | 2,760 | 7,850 | 15,162 | ||||||||||||
| Total other income | 112,393 | 30,390 | 273,729 | 86,890 | ||||||||||||
| Loss before taxes | (25,015,661 | ) | (19,472,645 | ) | (67,039,165 | ) | (67,594,347 | ) | ||||||||
| Provision for income taxes | - | - | - | - | ||||||||||||
| Net loss | $ | (25,015,661 | ) | $ | (19,472,645 | ) | $ | (67,039,165 | ) | $ | (67,594,347 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.13 | ) | $ | (0.11 | ) | $ | (0.34 | ) | $ | (0.39 | ) | ||||
| Weighted average number of common | ||||||||||||||||
| shares outstanding | 196,502,327 | 177,206,168 | 195,912,173 | 171,589,595 |
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
| Nine Months Ended | ||||||||
| September 30, 2016 | September 30, 2015 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||
| Net loss | $ | (67,039,165 | ) | $ | (67,594,347 | ) | ||
| Adjustments to reconcile net loss to net cash flows used in | ||||||||
| operating activities: | ||||||||
| Depreciation of fixed assets | 45,759 | 22,104 | ||||||
| Amortization of intangible assets | 38,560 | 22,296 | ||||||
| Provision for doubtful accounts | 2,261,568 | 37,163 | ||||||
| Share-based compensation | 13,385,215 | 4,740,906 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | (4,245,151 | ) | (1,549,532 | ) | ||||
| Inventory | (153,245 | ) | 312,054 | |||||
| Other current assets | 379,930 | (621,923 | ) | |||||
| Other assets | - | (15,162 | ) | |||||
| Accounts payable | 1,098,245 | (1,025,504 | ) | |||||
| Deferred revenue | - | (522,613 | ) | |||||
| Other current liabilities | 703,895 | 2,546,138 | ||||||
| Other long-term liabilities | - | 1,213,874 | ||||||
| Net cash used in operating activities | (53,524,389 | ) | (62,434,546 | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||
| Patent costs | (541,686 | ) | (117,992 | ) | ||||
| Purchase of fixed assets | (307,714 | ) | (15,559 | ) | ||||
| Payment of security deposit | (14,036 | ) | - | |||||
| Net cash used in investing activities | (863,436 | ) | (133,551 | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||
| Proceeds from sale of common stock, net of costs | 134,863,475 | 91,374,649 | ||||||
| Proceeds from exercise of warrants | 1,373,000 | 366,000 | ||||||
| Proceeds from exercise of options | 979,060 | 589,829 | ||||||
| Net cash provided by financing activities | 137,215,535 | 92,330,478 | ||||||
| Increase in cash | 82,827,710 | 29,762,381 | ||||||
| Cash, beginning of period | 64,706,355 | 51,361,607 | ||||||
| Cash, end of period | $ | 147,534,065 | $ | 81,123,988 |