Full Press Release Details
TherapeuticsMD, Inc. 8-K
Announces Third Quarter 2015 Financial Results
Topline phase 3 data anticipated in fourth quarter for TX-004HR to treat symptoms of VVA -
Completed enrollment in phase 3 Replenish Trial for first potential FDA-approved
oral combination hormone therapy -
Management to host conference call today at 4:30 p.m. EST -
TherapeuticsMD, Inc. (NYSE
an innovative women's
today announced its third quarter financial results for the period ended September
and Third Quarter Developments
we pursue our mission to address women's health needs, we believe that there is a unique confluence of factors evolving
on the scientific, regulatory, legislative and commercial fronts that will help us to make significant progress toward delivering
on our vision and strategy," said TherapeuticsMD
CEO Robert G. Finizio.
"We continue to execute both commercially and in R&D, including completion of enrollment in our Replenish Trial
of TX-001HR, our combination estradiol and progesterone drug candidate for treatment of moderate to severe vasomotor symptoms
due to menopause. We also expect topline data from our Rejoice Trial of TX-004HR for dyspareunia associated with VVA by the end
of this year. The market need for our products is large and growing, and we are building key alliances with healthcare providers,
women's health advocates and industry organizations."
Quarter Financial Results Summary
net for the third quarter of 2015 increased by 24 percent to approximately $5.2 million compared with revenues, net of approximately
$4.2 million for the prior year's quarter. Revenue growth during the third quarter was primarily driven by increased number
of units sold, product mix, and average net sales price of the company's prenatal vitamin products.
of goods sold increased to approximately $1.2 million for the three months ended September 30, 2015, compared with approximately
$1.1 million in the prior year's quarter.
operating expenses for the third quarter of 2015 included research and development (R&D) expenses and sales, general and administration
(SG&A). R&D expenses for the third quarter of 2015 were approximately $16.4 million compared with approximately $14.9
million for the prior year's quarter. The increase in R&D expense was primarily
due to an increase in scale-up and manufacturing activities for the company's phase 3 drugs in development, which was partially
offset by lower clinical trial costs. SG&A expenses for the third quarter of 2015 were approximately $7.0 million compared
with approximately $6.0 million for the third quarter of 2014, primarily as a result of increases in human resources costs and
professional fees, which were partially offset by a decrease in marketing costs.
income remained insignificant for the third quarter of 2015 and
2014 and included miscellaneous and interest income for both periods.
loss for the third quarter of 2015 was approximately $19.5 million, or $0.11 per basic and diluted share, compared with approximately
$17.8 million, or $0.12 per basic and diluted share, for the third quarter of 2014.
September 30, 2015, TherapeuticsMD had cash on hand of approximately $81.1 million, compared with approximately $51.4 million
at December 31, 2014.
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: | Wednesday, November 4, 2015 | |
| Time: | 4:30 p.m. EST | |
| Telephone Access (US): | 866-665-9531 | |
| Telephone Access (International): | 724-987-6977 | |
| Access Code for All Callers: | 61714687 |
a live webcast can be accessed on the company's website, www.therapeuticsmd.com,
on the "Home Page" or under
the "Investor" section.
TherapeuticsMD, Inc.
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: www.therapeuticsmd.com, www.vitamedmd.com, www.vitamedmdrx.com and www.bocagreenmd.com.
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; 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.
Chief Financial Officer
| THERAPEUTICSMD, INC. AND SUBSIDIARIES | ||||||||
| CONSOLIDATED BALANCE SHEETS | ||||||||
| September 30, 2015 | December 31, 2014 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash | $ | 81,123,988 | $ | 51,361,607 | ||||
| Accounts receivable, net of allowance for doubtful accounts | ||||||||
| of $96,916 and $59,753, respectively | 3,666,586 | 2,154,217 | ||||||
| Inventory | 870,059 | 1,182,113 | ||||||
| Other current assets | 2,120,805 | 1,537,407 | ||||||
| Total current assets | 87,781,438 | 56,235,344 | ||||||
| Fixed assets, net | 56,748 | 63,293 | ||||||
| Other Assets: | ||||||||
| Prepaid expense | 1,172,051 | 1,427,263 | ||||||
| Intangible assets, net | 1,324,284 | 1,228,588 | ||||||
| Security deposit | 125,000 | 125,000 | ||||||
| Total other assets | 2,621,335 | 2,780,851 | ||||||
| Total assets | $ | 90,459,521 | $ | 59,079,488 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 5,301,625 | $ | 6,327,129 | ||||
| Other current liabilities | 6,386,777 | 3,840,639 | ||||||
| Deferred revenue | - | 522,613 | ||||||
| Total current liabilities | 11,688,402 | 10,690,381 | ||||||
| Long-Term Liabilities: | ||||||||
| Accrued expenses | 1,213,874 | - | ||||||
| Total liabilities | 12,902,276 | 10,690,381 | ||||||
| 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 and 250,000,000 shares | ||||||||
| authorized; 177,787,927 and 156,097,019 issued and outstanding, respectively | 177,788 | 156,097 | ||||||
| Additional paid-in capital | 279,723,640 | 182,982,846 | ||||||
| Accumulated deficit | (202,344,183 | ) | (134,749,836 | ) | ||||
| Total stockholders' equity | 77,557,245 | 48,389,107 | ||||||
| Total liabilities and stockholders' equity | $ | 90,459,521 | $ | 59,079,488 |
| THERAPEUTICSMD, INC. AND SUBSIDIARIES |
| CONSOLIDATED STATEMENTS OF OPERATIONS |
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | |||||||||||||
| Revenues, net | $ | 5,190,175 | $ | 4,186,261 | $ | 14,513,158 | $ | 10,768,572 | ||||||||
| Cost of goods sold | 1,193,965 | 1,068,605 | 3,270,695 | 2,792,268 | ||||||||||||
| Gross profit | 3,996,210 | 3,117,656 | 11,242,463 | 7,976,304 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Sales, general, and administration | 7,060,944 | 6,043,354 | 20,089,998 | 16,610,015 | ||||||||||||
| Research and development | 16,421,753 | 14,909,430 | 58,789,302 | 29,052,149 | ||||||||||||
| Depreciation and amortization | 16,548 | 12,747 | 44,400 | 39,909 | ||||||||||||
| Total operating expenses | 23,499,245 | 20,965,531 | 78,923,700 | 45,702,073 | ||||||||||||
| Operating loss | (19,503,035 | ) | (17,847,875 | ) | (67,681,237 | ) | (37,725,769 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Miscellaneous income | 27,630 | 6,260 | 71,728 | 43,411 | ||||||||||||
| Interest income | 2,760 | 9,364 | 15,162 | 27,756 | ||||||||||||
| Financing costs | - | - | - | (260,027 | ) | |||||||||||
| Total other income (expense) | 30,390 | 15,624 | 86,890 | (188,860 | ) | |||||||||||
| Loss before income taxes | (19,472,645 | ) | (17,832,251 | ) | (67,594,347 | ) | (37,914,629 | ) | ||||||||
| Provision for income taxes | - | - | - | - | ||||||||||||
| Net loss | $ | (19,472,645 | ) | $ | (17,832,251 | ) | $ | (67,594,347 | ) | $ | (37,914,629 | ) | ||||
| Loss per share, basic and diluted: | ||||||||||||||||
| Net loss per share, basic and diluted | $ | (0.11 | ) | $ | (0.12 | ) | $ | (0.39 | ) | $ | (0.26 | ) | ||||
| Weighted average number of common | ||||||||||||||||
| shares outstanding, basic and diluted | 177,206,168 | 152,200,455 | 171,589,595 | 147,594,810 |
| THERAPEUTICSMD, INC. AND SUBSIDIARIES |
| CONSOLIDATED STATEMENTS OF CASH FLOWS |
| (Unaudited) |
| Nine Months Ended | ||||||||
| September 30, 2015 | September 30, 2014 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||
| Net loss | $ | (67,594,347 | ) | $ | (37,914,629 | ) | ||
| Adjustments to reconcile net loss to net cash used in | ||||||||
| operating activities: | ||||||||
| Depreciation | 22,104 | 22,713 | ||||||
| Amortization of intangible assets | 22,296 | 17,196 | ||||||
| Provision for doubtful accounts | 37,163 | 2,594 | ||||||
| Share-based compensation | 4,740,906 | 3,934,836 | ||||||
| Amortization of deferred financing costs | - | 260,027 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | (1,549,532 | ) | (460,565 | ) | ||||
| Inventory | 312,054 | 31,673 | ||||||
| Other current assets | (621,923 | ) | 197,569 | |||||
| Other assets | (15,162 | ) | (17,069 | ) | ||||
| Accounts payable | (1,025,504 | ) | 3,534,462 | |||||
| Deferred revenue | (522,613 | ) | (754,431 | ) | ||||
| Other current liabilities | 2,546,138 | 909,890 | ||||||
| Long term accrued expenses | 1,213,874 | - | ||||||
| Net cash used in operating activities | (62,434,546 | ) | (30,235,734 | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||
| Patent costs | (117,992 | ) | (193,349 | ) | ||||
| Purchase of property and equipment | (15,559 | ) | (30,962 | ) | ||||
| Net cash used in investing activities | (133,551 | ) | (224,311 | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||
| Proceeds from sale of common stock, net of costs | 91,374,649 | 42,771,353 | ||||||
| Proceeds from exercise of options | 589,829 | 315,546 | ||||||
| Proceeds from exercise of warrants | 366,000 | 181,000 | ||||||
| Net cash provided by financing activities | 92,330,478 | 43,267,899 | ||||||
| Increase in cash | 29,762,381 | 12,807,854 | ||||||
| Cash, beginning of period | 51,361,607 | 54,191,260 | ||||||
| Cash, end of period | $ | 81,123,988 | $ | 66,999,114 |