Full Press Release Details
TherapeuticsMD, Inc. 8-K
TherapeuticsMD Announces Second Quarter
2016 Financial Results
- New Drug Application submitted
for Yuvvexy (TX-004HR) -
- Topline phase 3 data for TX-001HR
Replenish Trial on track for fourth quarter of 2016 -
August 4, 2016 - TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women's healthcare company, today announced
its second quarter financial results for the quarter ended June 30, 2016.
Second Quarter and Recent Developments
"The second quarter was transformative
for our company, with the submission of our NDA for Yuvvexy as a highly-differentiated potential treatment for moderate to severe
dyspareunia, a symptom of VVA, due to menopause," said TherapeuticsMD CEO Robert G. Finizio. "The Yuvvexy NDA reflects
a significant corporate achievement and we are thankful for the contributions of everyone involved. As we prepare for future commercialization
of Yuvvexy, if approved, we also look forward to the topline data in the fourth quarter of 2016 from our Replenish Trial for TX-001HR,
our second novel hormone therapy program. If approved, we believe TX-001HR would be the first and only FDA-approved bio-identical
combination of estradiol and progesterone for treatment of moderate-to-severe vasomotor symptoms due to menopause. We are very
pleased with our progress this year."
Summary of Second Quarter 2016
For the quarter ended June 30, 2016, net revenue
from the company's prescription prenatal vitamins was approximately $4.4 million compared with net revenue of approximately
$4.8 million for the prior year's quarter. The change in net revenue during the quarter was primarily attributable to a decrease
in the average net sales price of the company's products, partially offset by an increase in the number of units sold.
Cost of goods sold was approximately $1.1 million
for the three months ended June 30, 2016, compared with approximately $1.0 million in the prior year's quarter.
Total operating expenses for the second quarter
of 2016 included research and development (R&D) expenses and sales, general and administrative expenses (SG&A). R&D
expenses during the second quarter of 2016 were approximately $13.8 million compared to approximately $24.2 million during the
prior year's quarter, reflecting a significant decline in the company's clinical trial costs, partially offset by an
increase in scale-up and manufacturing activities to support future commercialization. SG&A expenses for the second quarter
of 2016 were approximately $10.6 million compared with approximately $6.9 million for the prior year's quarter, primarily
due to the company's investments in human resources and sales and marketing to support future commercialization.
Net loss for the second quarter of 2016 was
approximately $21.1 million, or $0.11 per basic and diluted share, compared with approximately $27.2 million, or $0.16 per basic
and diluted share, for the second quarter of 2015.
At June 30, 2016, cash on hand was approximately
$166.5 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, August 4, 2016 |
| Time: | 4:30 p.m. EDT |
| Telephone Access (US): | 866-665-9531 |
| Telephone Access (International): | 724-987-6977 |
| Access Code for All Callers: | 88600937 |
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: 46530545.
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:
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 accept and, if accepted,
approve the company's new drug application for its TX-004HR product candidate; 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
Director, Investor Relations
THERAPEUTICSMD, INC. AND
CONSOLIDATED BALANCE SHEETS
| June 30, 2016 | December 31, 2015 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash | $ | 166,532,446 | $ | 64,706,355 | ||||
| Accounts receivable, net of allowance for doubtful accounts of $529,298 and $81,910, respectively | 4,477,308 | 3,049,715 | ||||||
| Inventory | 883,656 | 690,153 | ||||||
| Other current assets | 2,136,735 | 2,233,897 | ||||||
| Total current assets | 174,030,145 | 70,680,120 | ||||||
| Fixed assets, net | 444,412 | 198,592 | ||||||
| Other Assets: | ||||||||
| Intangible assets, net | 1,983,829 | 1,615,251 | ||||||
| Prepaid expense | - | 1,109,883 | ||||||
| Security deposit | 129,864 | 125,000 | ||||||
| Total other assets | 2,113,693 | 2,850,134 | ||||||
| Total assets | $ | 176,588,250 | $ | 73,728,846 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 3,039,388 | $ | 3,126,174 | ||||
| Other current liabilities | 6,299,783 | 7,539,526 | ||||||
| Total current liabilities | 9,339,171 | 10,665,700 | ||||||
| Total liabilities | 9,339,171 | 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; 196,492,195 and 177,928,041 issued and outstanding, respectively | 196,492 | 177,928 | ||||||
| Additional paid in capital | 428,902,951 | 282,712,078 | ||||||
| Accumulated deficit | (261,850,364 | ) | (219,826,860 | ) | ||||
| Total stockholders' equity | 167,249,079 | 63,063,146 | ||||||
| Total liabilities and stockholders' equity | $ | 176,588,250 | $ | 73,728,846 |
THERAPEUTICSMD, INC. AND
CONSOLIDATED STATEMENTS
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Revenues, net | $ | 4,403,247 | $ | 4,847,934 | $ | 9,333,338 | $ | 9,322,983 | ||||||||
| Cost of goods sold | 1,130,108 | 1,033,089 | 2,238,551 | 2,076,730 | ||||||||||||
| Gross profit | 3,273,139 | 3,814,845 | 7,094,787 | 7,246,253 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Sales, general, and administration | 10,619,006 | 6,865,442 | 20,297,558 | 13,029,054 | ||||||||||||
| Research and development | 13,841,193 | 24,190,714 | 28,938,210 | 42,367,549 | ||||||||||||
| Depreciation and amortization | 24,262 | 14,280 | 43,859 | 27,852 | ||||||||||||
| Total operating expense | 24,484,461 | 31,070,436 | 49,279,627 | 55,424,455 | ||||||||||||
| Operating loss | (21,211,322 | ) | (27,255,591 | ) | (42,184,840 | ) | (48,178,202 | ) | ||||||||
| Other income: | ||||||||||||||||
| Miscellaneous income | 114,320 | 25,585 | 155,937 | 44,098 | ||||||||||||
| Accreted interest | 2,863 | 2,560 | 5,399 | 12,402 | ||||||||||||
| Total other income | 117,183 | 28,145 | 161,336 | 56,500 | ||||||||||||
| Loss before taxes | (21,094,139 | ) | (27,227,446 | ) | (42,023,504 | ) | (48,121,702 | ) | ||||||||
| Provision for income taxes | - | - | - | - | ||||||||||||
| Net loss | $ | (21,094,139 | ) | $ | (27,227,446 | ) | $ | (42,023,504 | ) | $ | (48,121,702 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.11 | ) | $ | (0.16 | ) | $ | (0.21 | ) | $ | (0.29 | ) | ||||
| Weighted average number of common shares outstanding | 196,325,715 | 172,782,264 | 195,613,639 | 168,734,760 |
THERAPEUTICSMD, INC. AND
CONSOLIDATED STATEMENTS
| Six Months Ended | ||||||||
| June 30, 2016 | June 30, 2015 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||
| Net loss | $ | (42,023,504 | ) | $ | (48,121,702 | ) | ||
| Adjustments to reconcile net loss to net cash flows used in operating activities: | ||||||||
| Depreciation of fixed assets | 19,216 | 14,248 | ||||||
| Amortization of intangible assets | 24,643 | 13,604 | ||||||
| Provision for doubtful accounts | 447,388 | 30,767 | ||||||
| Share-based compensation | 9,200,844 | 2,968,811 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | (1,874,980 | ) | (1,190,068 | ) | ||||
| Inventory | (193,503 | ) | (66,606 | ) | ||||
| Other current assets | 1,001,120 | 383,194 | ||||||
| Other assets | - | (12,410 | ) | |||||
| Accounts payable | (86,786 | ) | (508,511 | ) | ||||
| Deferred revenue | - | (522,613 | ) | |||||
| Other current liabilities | (1,239,743 | ) | 2,047,264 | |||||
| Other long-term liabilities | - | 967,286 | ||||||
| Net cash used in operating activities | (34,725,305 | ) | (43,996,736 | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||
| Patent costs | (393,221 | ) | (78,792 | ) | ||||
| Purchase of fixed assets | (265,036 | ) | (15,559 | ) | ||||
| Payment of security deposit | (4,864 | ) | - | |||||
| Net cash used in investing activities | (663,121 | ) | (94,351 | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||
| Proceeds from sale of common stock, net of costs | 134,863,475 | 59,117,827 | ||||||
| Proceeds from exercise of warrants | 1,373,000 | 366,000 | ||||||
| Proceeds from exercise of options | 978,042 | 491,351 | ||||||
| Net cash provided by financing activities | 137,214,517 | 59,975,178 | ||||||
| Increase in cash | 101,826,091 | 15,884,091 | ||||||
| Cash, beginning of period | 64,706,355 | 51,361,607 | ||||||
| Cash, end of period | $ | 166,532,446 | $ | 67,245,698 |