Full Press Release Details
TherapeuticsMD, Inc. 8-K
announces first quarter 2015 financial results
First quarter product sales increased by 58 percent year over year -
Two phase 3 clinical trials advancing -
Management to host conference call today at 4:30 p.m. EDT -
- TherapeuticsMD, Inc.
TXMD), an innovative
company, today announced its first quarter
financial results for the period ended March 31, 2015.
quarter and recent corporate developments
are very excited about the developments at our company so far in 2015, and we are enthusiastic about our future prospects,"
said TherapeuticsMD CEO
Robert G. Finizio. "We are
enrolling patients in our two phase 3 clinical trials for novel hormone therapy product candidates, we are executing well in our
current women's health business, and we have compelling new science that is emerging from our earlier stage pipeline programs.
We are making great progress toward our goal to build a leading women's health company."
first quarter financial results
Net revenue for the first quarter of 2015 totaled
approximately $4.5 million compared with net revenue of approximately $2.8 million for the prior year's quarter, an increase
of approximately 58 percent. Revenue growth during the first 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 March 31, 2015, compared with approximately $831,000 in the prior year's quarter.
Total operating expenses for the first quarter
of 2015 included research and development (R&D) expenses and sales, general and administrative expenses (SG&A). R&D
expenses for the first quarter of 2015 were approximately $18.2 million compared with approximately $5.9 million for the prior
year's quarter, reflecting costs of the company's two ongoing phase 3 clinical
trials, as well as scale-up and manufacturing activities for its novel hormone therapy products in development. SG&A expenses
for the first quarter of 2015 were approximately $6.2 million compared with approximately $5.0 million for the first quarter of
2014, primarily as a result of increased personnel costs and legal and accounting expenses.
income for the first quarter of 2015 included miscellaneous and interest income of approximately
$28,000, compared with a non-operating loss of approximately $232,000 during the prior year's quarter. The non-operating
loss during the first quarter of 2014 included financing costs of approximately $260,000.
Net loss for the first quarter of 2015 was
approximately $20.9 million, or $0.13 per basic and diluted share, compared with approximately $9.2 million, or $0.06 per basic
and diluted share, for the first quarter of 2014.
31, 2015, TherapeuticsMD had cash on hand of approximately $91.7 million, compared with approximately $51.4 million at December
31, 2014. In February 2015, the company completed a public offering of shares of its common stock for net proceeds of approximately
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 include:
| Date: | Tuesday, May 5, 2015 |
| Time: | 4:30 p.m. EDT |
| Telephone Access (US): | 866-665-9531 |
| Telephone Access (International): | 724-987-6977 |
| Access Code for All Callers: | 28458424 |
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 platform,
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
INC. AND SUBSIDIARIES
| March 31, 2015 | December 31, 2014 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash | $ | 91,658,453 | $ | 51,361,607 | ||||
| Accounts receivable, net of allowance for doubtful accounts | ||||||||
| of $72,757 and $59,753, respectively | 2,644,049 | 2,154,217 | ||||||
| Inventory | 959,188 | 1,182,113 | ||||||
| Other current assets | 1,445,995 | 1,537,407 | ||||||
| Total current assets | 96,707,685 | 56,235,344 | ||||||
| Fixed assets, net | 56,412 | 63,293 | ||||||
| Other Assets: | ||||||||
| Prepaid expense | 1,334,139 | 1,427,263 | ||||||
| Intangible assets | 1,258,750 | 1,228,588 | ||||||
| Security deposit | 125,000 | 125,000 | ||||||
| Total other assets | 2,717,889 | 2,780,851 | ||||||
| Total assets | $ | 99,481,986 | $ | 59,079,488 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 6,235,183 | $ | 6,327,129 | ||||
| Other current liabilities | 4,879,452 | 3,840,639 | ||||||
| Deferred revenue | - | 522,613 | ||||||
| Total current liabilities | 11,114,635 | 10,690,381 | ||||||
| Long-Term Liabilities: | ||||||||
| Accrued Expense | 651,567 | - | ||||||
| Total liabilities | 11,766,202 | 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; 250,000,000 shares authorized; | ||||||||
| 172,651,036 and 156,097,019 issued and outstanding, respectively | 172,651 | 156,097 | ||||||
| Additional paid in capital | 243,187,225 | 182,982,846 | ||||||
| Accumulated deficit | (155,644,092 | ) | (134,749,836 | ) | ||||
| Total stockholders' equity | 87,715,784 | 48,389,107 | ||||||
| Total liabilities and stockholders' equity | $ | 99,481,986 | $ | 59,079,488 |
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
| Three Months Ended | ||||||||
| March 31, 2015 | March 31, 2014 | |||||||
| Revenues, net | $ | 4,475,049 | $ | 2,830,533 | ||||
| Cost of goods sold | 1,043,641 | 830,707 | ||||||
| Gross profit | 3,431,408 | 1,999,826 | ||||||
| Operating expenses: | ||||||||
| Sales, general, and administrative | 6,163,612 | 5,029,497 | ||||||
| Research and development | 18,176,835 | 5,908,078 | ||||||
| Depreciation and amortization | 13,572 | 13,068 | ||||||
| Total operating expense | 24,354,019 | 10,950,643 | ||||||
| Operating loss | (20,922,611 | ) | (8,950,817 | ) | ||||
| Other income and (expense) | ||||||||
| Miscellaneous income | 18,513 | 18,572 | ||||||
| Interest income | 9,842 | 9,154 | ||||||
| Financing costs | - | (260,027 | ) | |||||
| Total other income (expense) | 28,355 | (232,301 | ) | |||||
| Loss before taxes | (20,894,256 | ) | (9,183,118 | ) | ||||
| Provision for income taxes | - | - | ||||||
| Net loss | $ | (20,894,256 | ) | $ | (9,183,118 | ) | ||
| Net loss per share, basic and diluted | $ | (0.13 | ) | $ | (0.06 | ) | ||
| Weighted average number of common | ||||||||
| shares outstanding-basic and diluted | 163,448,130 | 145,019,561 |
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
| Three Months Ended | ||||||||
| March 31, 2015 | March 31, 2014 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||
| Net loss | $ | (20,894,256 | ) | $ | (9,183,118 | ) | ||
| Adjustments to reconcile net loss to net cash flows used in | ||||||||
| operating activities: | ||||||||
| Depreciation | 6,881 | 7,122 | ||||||
| Amortization of intangible assets | 6,691 | 5,946 | ||||||
| Provision for doubtful accounts | 13,004 | 6,046 | ||||||
| Stock based compensation | 704,872 | 1,009,526 | ||||||
| Amortization of deferred financing costs | - | 260,027 | ||||||
| Stock based expense for services | 135,592 | 314,291 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | (502,836 | ) | (654,748 | ) | ||||
| Inventory | 222,925 | 122,933 | ||||||
| Other current assets | 91,412 | (85,834 | ) | |||||
| Other assets | (9,842 | ) | (9,154 | ) | ||||
| Accounts payable | (91,946 | ) | 954,513 | |||||
| Deferred revenue | (522,613 | ) | (124,271 | ) | ||||
| Accrued expenses and other current liabilities | 1,038,813 | (1,329,216 | ) | |||||
| Other long-term liabilities | 651,567 | - | ||||||
| Net cash flows used in operating activities | (19,149,736 | ) | (8,705,937 | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||
| Patent costs | (36,853 | ) | (97,284 | ) | ||||
| Purchase of property and equipment | - | (23,692 | ) | |||||
| Net cash flows used in investing activities | (36,853 | ) | (120,976 | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||
| Proceeds from sale of common stock, net of costs | 59,117,827 | - | ||||||
| Proceeds from exercise of options | 7,208 | 40,055 | ||||||
| Proceeds from exercise of warrants | 358,400 | - | ||||||
| Net cash flows provided by financing activities | 59,483,435 | 40,055 | ||||||
| Increase (decrease) in cash | 40,296,846 | (8,786,858 | ) | |||||
| Cash, beginning of period | 51,361,607 | 54,191,260 | ||||||
| Cash, end of period | $ | 91,658,453 | $ | 45,404,402 | ||||
| SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | ||||||||
| Cash paid for interest | $ | - | $ | - | ||||
| Cash paid for income taxes | $ | - | $ | - |