Full Press Release Details
TherapeuticsMD, Inc. 8-K
Announces Second Quarter 2015 Financial Results
in Fourth Quarter of 2015 -
Management to Host Conference call Today at 4:30 p.m. EDT -
2015 - TherapeuticsMD,
an innovative women's
today announced its second quarter financial results for the period ended June 30, 2015.
Quarter and Recent Developments
are very pleased with our progress during the second quarter, most notably completion of enrollment in our 700-patient Rejoice
Trial of TX-004HR for the treatment of moderate to severe dyspareunia as a symptom of VVA due to menopause, and ongoing recruitment
of patients for the phase 3 Replenish Trial of TX-001HR, our combination estradiol and progesterone product candidate,"
said TherapeuticsMD CEO
Robert G. Finizio. "We are
also focused on building alliances with key medical and industry organizations in order to generate awareness and knowledge of
the unmet medical needs among menopausal and post-menopausal women."
Summary of Second Quarter Financial
Net revenue for the second quarter of 2015
totaled approximately $4.8 million compared with net revenue of approximately $3.8 million for the prior year's quarter,
an increase of approximately 29 percent year over year. Revenue growth during the second quarter was primarily driven by increased
sales of the company's prenatal vitamin products and an increase in the average net sales price of the company's products.
Cost of goods sold increased to approximately
$1.0 million for the three months ended June 30, 2015, compared with approximately $0.9 million in the prior year's quarter.
Total operating expenses for the second quarter
of 2015 included research and development (R&D) expenses and sales, general and administrative expenses (SG&A). R&D
expenses for the second quarter of 2015 were approximately $24.2 million compared with approximately $8.2 million for the prior
year's quarter, reflecting costs of the company's two ongoing phase 3 clinical
trials for its novel hormone therapy products in development, including completion of enrollment in the Rejoice Trial, as well
as scale-up and manufacturing activities. SG&A expenses for the second quarter of 2015 were approximately $6.9 million compared
with approximately $5.5 million for the second quarter of 2014, primarily as a result of increased non-cash compensation, legal,
director and insurance expenses.
income remained insignificant and unchanged for both the second quarter of 2015 and 2014 and included miscellaneous and
interest income for both periods.
Net loss for the second quarter of 2015 was
approximately $27.2 million, or $0.16 per basic and diluted share, compared with approximately $10.9 million, or $0.07 per basic
and diluted share, for the second quarter of 2014.
At June 30, 2015, TherapeuticsMD had cash on
hand of approximately $67.2 million, compared with approximately $51.4 million at December
31, 2014. In July 2015, the company completed an underwritten public offering of shares of its common stock in which the net proceeds
to the company were approximately $32.2 million.
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 and webcast are:
Access (US): 866-665-9531
Access (International): 724-987-6977
Code for All Callers: 83546010
Additionally, a live webcast
can be accessed on the company's website, www.therapeuticsmd.com,
under the "Investor"
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is an innovative healthcare
company focused on developing and commercializing products exclusively for women. With its patented 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; 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
Chief Financial Officer
| THERAPEUTICSMD, INC. AND SUBSIDIARIES |
| CONSOLIDATED BALANCE SHEETS |
| June 30, 2015 | December 31, 2014 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash | $ | 67,245,698 | $ | 51,361,607 | ||||
| Accounts receivable, net of allowance for doubtful accounts of $90,520 and $59,753, respectively | 3,313,518 | 2,154,217 | ||||||
| Inventory | 1,248,719 | 1,182,113 | ||||||
| Other current assets | 1,154,213 | 1,537,407 | ||||||
| Total current assets | 72,962,148 | 56,235,344 | ||||||
| Fixed assets, net | 64,604 | 63,293 | ||||||
| Other Assets: | ||||||||
| Prepaid expense | 1,233,740 | 1,427,263 | ||||||
| Intangible assets | 1,293,776 | 1,228,588 | ||||||
| Security deposit | 125,000 | 125,000 | ||||||
| Total other assets | 2,652,516 | 2,780,851 | ||||||
| Total assets | $ | 75,679,268 | $ | 59,079,488 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 5,818,618 | $ | 6,327,129 | ||||
| Other current liabilities | 5,887,902 | 3,840,639 | ||||||
| Deferred revenue | - | 522,613 | ||||||
| Total current liabilities | 11,706,520 | 10,690,381 | ||||||
| Long-Term Liabilities: | ||||||||
| Accrued expense | 967,286 | - | ||||||
| Total liabilities | 12,673,806 | 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, respectively; 173,037,653 and 156,097,019 shares issued and outstanding, respectively | 173,038 | 156,097 | ||||||
| Additional paid in capital | 245,703,962 | 182,982,846 | ||||||
| Accumulated deficit | (182,871,538 | ) | (134,749,836 | ) | ||||
| Total stockholders' equity | 63,005,462 | 48,389,107 | ||||||
| Total liabilities and stockholders' equity | $ | 75,679,268 | $ | 59,079,488 |
| THERAPEUTICSMD, INC. AND SUBSIDIARIES |
| CONSOLIDATED STATEMENTS OF OPERATIONS |
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | |||||||||||||
| Revenues, net | $ | 4,847,934 | $ | 3,751,778 | $ | 9,322,983 | $ | 6,582,311 | ||||||||
| Cost of goods sold | 1,033,089 | 892,956 | 2,076,730 | 1,723,663 | ||||||||||||
| Gross profit | 3,814,845 | 2,858,822 | 7,246,253 | 4,858,648 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Sales, general, and administration | 6,865,442 | 5,537,164 | 13,029,054 | 10,566,661 | ||||||||||||
| Research and development | 24,190,714 | 8,234,641 | 42,367,549 | 14,142,719 | ||||||||||||
| Depreciation and amortization | 14,280 | 14,094 | 27,852 | 27,162 | ||||||||||||
| Total operating expense | 31,070,436 | 13,785,899 | 55,424,455 | 24,736,542 | ||||||||||||
| Operating loss | (27,255,591 | ) | (10,927,077 | ) | (48,178,202 | ) | (19,877,894 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Miscellaneous income | 25,585 | 18,579 | 44,098 | 37,151 | ||||||||||||
| Interest income | 2,560 | 9,238 | 12,402 | 18,392 | ||||||||||||
| Financing costs | - | - | - | (260,027 | ) | |||||||||||
| Total other income (expense) | 28,145 | 27,817 | 56,500 | (204,484 | ) | |||||||||||
| Loss before taxes | (27,227,446 | ) | (10,899,260 | ) | (48,121,702 | ) | (20,082,378 | ) | ||||||||
| Provision for income taxes | - | - | - | - | ||||||||||||
| Net loss | $ | (27,227,446 | ) | $ | (10,899,260 | ) | $ | (48,121,702 | ) | $ | (20,082,378 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.16 | ) | $ | (0.07 | ) | $ | (0.29 | ) | $ | (0.14 | ) | ||||
| Weighted average number of common shares outstanding | 172,782,264 | 145,485,505 | 168,734,760 | 145,253,818 |
| THERAPEUTICSMD, INC. AND SUBSIDIARIES |
| CONSOLIDATED STATEMENTS OF CASH FLOWS |
| (Unaudited) |
| Six Months Ended | ||||||||
| June 30, 2015 | June 30, 2014 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||
| Net loss | $ | (48,121,702 | ) | $ | (20,082,378 | ) | ||
| Adjustments to reconcile net loss to net cash flows used in operating activities: | ||||||||
| Depreciation | 14,248 | 15,591 | ||||||
| Amortization of intangible assets | 13,604 | 11,570 | ||||||
| Provision for doubtful accounts | 30,767 | 1,393 | ||||||
| Stock based compensation | 2,052,549 | 2,268,599 | ||||||
| Amortization of deferred financing costs | - | 260,027 | ||||||
| Stock based expense for services | 916,262 | 481,024 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | (1,190,068 | ) | (475,378 | ) | ||||
| Inventory | (66,606 | ) | (409,376 | ) | ||||
| Other current assets | 383,194 | (460,512 | ) | |||||
| Other assets | (12,410 | ) | (18,392 | ) | ||||
| Accounts payable | (508,511 | ) | 216,040 | |||||
| Deferred revenue | (522,613 | ) | (314,784 | ) | ||||
| Accrued expenses and other current liabilities | 2,047,264 | (271,771 | ) | |||||
| Other long-term liabilities | 967,286 | - | ||||||
| Net cash flows used in operating activities | (43,996,736 | ) | (18,778,347 | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||
| Patent costs | (78,792 | ) | (213,089 | ) | ||||
| Purchase of property and equipment | (15,559 | ) | (30,962 | ) | ||||
| Refund of security deposit | - | 10,686 | ||||||
| Net cash flows used in investing activities | (94,351 | ) | (233,365 | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||
| Proceeds from sale of common stock, net of costs | 59,117,827 | - | ||||||
| Proceeds from exercise of options | 491,351 | 287,288 | ||||||
| Proceeds from exercise of warrants | 366,000 | 87,000 | ||||||
| Net cash flows provided by financing activities | 59,975,178 | 374,288 | ||||||
| Increase (decrease) in cash | 15,884,091 | (18,637,424 | ) | |||||
| Cash, beginning of period | 51,361,607 | 54,191,260 | ||||||
| Cash, end of period | $ | 67,245,698 | $ | 35,553,836 | ||||
| SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | ||||||||
| Cash paid for interest | $ | - | $ | - | ||||
| Cash paid for income taxes | $ | - | $ | - |