UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): August 6, 2013
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TherapeuticsMD, Inc.
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(Exact Name of Registrant as Specified in its Charter)
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Nevada
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000-16731
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87-0233535
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(State or Other
Jurisdiction of Incorporation)
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(Commission File Number)
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(IRS Employer
Identification No.)
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6800 Broken Sound Parkway NW,
Third Floor
Boca Raton, FL 33487
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(Address of Principal Executive Office) (Zip Code)
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Registrant's telephone number, including area code: (561) 961-1900
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2 below):
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o
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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o
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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o
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Item 2.02.
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Results of Operations and Financial Condition.
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On August 6, 2013, TherapeuticsMD, Inc. issued a press release announcing its results of operations for its second fiscal quarter ended June 30, 2013. A copy of the press release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.
The information in this Current Report on Form 8-K (including the exhibit) is furnished pursuant to Item 2.02 and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The information in this Current Report shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date of this Current Report, regardless of any general incorporation language in the filing.
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Item 9.01.
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Financial Statements and Exhibits.
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(d) Exhibits.
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Exhibit
Number
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Description
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99.1
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Press Release from TherapeuticsMD, Inc., dated August 6, 2013, entitled “TherapeuticsMD Reports Second Quarter 2013 Financial Results”.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: August 6, 2013 | THERAPEUTICSMD, INC. | ||
| By: | /s/ Daniel A. Cartwright | ||
| Name: | Daniel A. Cartwright | ||
| Title: | Chief Financial Officer | ||
EXHIBIT INDEX
Exhibit 99.1
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Contacts:
Dan Cartwright Chief Financial Officer
Tel: (561) 961-1930
Dan.Cartwright@TherapeuticsMD.com
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Investor Relations:
Lisa M. Wilson
In-Site Communications
Tel: (917) 543-9932
lwilson@insitecony.com
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FOR IMMEDIATE RELEASE
THERAPEUTICSMD REPORTS SECOND QUARTER 2013 FINANCIAL RESULTS
Boca Raton, FL, August 6, 2013 – TherapeuticsMD, Inc. (NYSE MKT: TXMD), a women’s healthcare company focused on developing and commercializing products targeted exclusively for women, today announced financial results for the three and six-month periods ended June 30, 2013.
Second Quarter Highlights:
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·
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Net revenue for the quarter ended June 30, 2013 was $2.1 million compared with $819 thousand in the second quarter of 2012;
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·
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Net loss improved to $6.0 million for the quarter ended June 30, 2013 compared with a net loss of $11.9 million in the second quarter of 2012;
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·
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On June 10, 2013, the U.S. Food and Drug Administration (FDA) accepted the Company’s Investigational New Drug (IND) application for TX 12-004HR, a vulvar and vaginal atrophy product; and
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·
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TXMD was added to the Russell 2000® on June 28, 2013.
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Robert G. Finizio, Co-Founder and Chief Executive Officer, stated, “With the FDA’s acceptance of the IND application for TX 12-004HR, we are now positioned to move three product candidates into late-stage clinical trials. We remain on track to initiate pivotal Phase III clinical trials for our bioidentical, 17β estradiol/ progesterone combination and lower-dose oral progesterone product candidates in the second half of this year. We are presently conducting pharmacokinetic studies with TX 12-004HR and expect to initiate a Phase III clinical trial early next year.”
Second Quarter Results
Net revenue for the second quarter of 2013 totaled $2.1 million compared with net revenue of $819 thousand for the year ago quarter. The increase of $1.3 million, or 154%, was directly attributable to an increase in sales territories, sales people and new prescription products. Cost of goods sold increased by $92 thousand, or 25%, for the three months ended June 30, 2013 compared with the prior year quarter. Research and development expense increased to $1.7 million during the second quarter of 2013 compared with $833 thousand in the second quarter of 2012, due to costs incurred in the development of our new hormone replacement therapy and prescription prenatal products. Sales, general and administrative expenses increased to $5.5 million during the second quarter of 2013 compared with $3.6 million in the second quarter of 2012. As a result, our operating loss was $5.6 million in the second quarter of 2013 compared with $4.0 million in the second quarter of 2012.
Other non-operating expense decreased by $7.5 million for the second quarter of 2013 compared with the comparable quarter in 2012. This decrease resulted primarily from the beneficial conversion of debt and interest expense incurred during 2012, partially offset by an increase in amortization of financing costs of $396 thousand.
As a result, net loss for the second quarter of 2013 was $6.0 million, or $0.05 per basic and diluted share, compared with a net loss of $11.9 million, or $0.14 per basic and diluted share, in the second quarter of 2012.
- Page 1 -
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TherapeuticsMD Reports Second Quarter 2013 Financial Results
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Page 2
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August 6, 2013
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Six Months Results
Net revenue for the first half of 2013 totaled $3.6 million, compared with revenue of $1.5 million for the year ago period. The increase of $2.1 million, or 135%, was directly attributable to an increase in sales territories, sales people and new prescription products. Cost of goods sold increased by $135 thousand, or 20%, for the six months ended June 30, 2013 compared with the prior year period. Research and development expenses increased to $3.3 million during the first half of 2013 compared with $1.2 million in the first half of 2012, due to costs incurred in the development of our new hormone replacement therapy and prescription prenatal products. Sales, general and administrative expenses increased to $10.0 million during the first half of 2013 compared with $6.4 million in the first half of 2012. As a result, our operating loss was $10.6 million in the first half of 2013 compared with $6.8 million in the first half of 2012.
Other non-operating expense decreased by $16.5 million for the first half of 2013 compared with the comparable period in 2012. This decrease resulted primarily from a loss on extinguishment of debt, the beneficial conversion of debt and interest expense incurred during 2012, partially offset by an increase in amortization of financing costs of $660 thousand.
As a result, net loss for the first half of 2013 was $12.4 million, or $0.11 per basic and diluted share, compared with a net loss of $25.1 million, or $0.29 per basic and diluted share, in the first half of 2012.
Cash and cash equivalents increased to $34.4 million at June 30, 2013.
About Hormone Therapy
Hormone therapy (HT) is the administration of hormones to supplement a lack of naturally occurring hormones. HT options include natural, bioidentical, and non-bioidentical (conjugated) hormones. HT is projected to be the largest growth segment in the overall women’s health market. The potential market for pharmacy-compounded, bioidentical HT products is estimated to be approximately $1.5 billion per year.
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is a women’s healthcare company focused on developing and commercializing products targeted exclusively for women. We manufacture and distribute branded and generic prescription prenatal vitamins, as well as over-the-counter vitamins and cosmetics, under our vitaMedMD® and BocaGreenMD™ brands. We are currently developing advanced hormone therapy pharmaceutical products designed to alleviate the symptoms of and reduce the health risks resulting from menopause-related hormone deficiencies. We are also evaluating various other potential indications for our hormone technology, including oral contraception, preterm birth, vulvar and vaginal atrophy, and premature ovarian failure. More information is available at the following websites: www.therapeuticsmd.com, www.vitamedmd.com, www.vitamedmdrx.com, and www.bocagreenmd.com.
vitaMedMD® is a registered trademark and TherapeuticsMD™ and BocaGreenMD™ are trademarks of TherapeuticsMD, Inc.
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TherapeuticsMD Reports Second Quarter 2013 Financial Results
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Page 3
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August 6, 2013
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Except for the historical information contained herein, the matters set forth in this press release, including statements regarding the Company’s belief that it is now positioned to move three product candidates into late-stage clinical trials, the Company’s expectations with respect to the timing of its clinical trials, and the status of the pharmacokinetic studies with TX 12-004HR are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including but not limited to: timely and successful completion of clinical studies and the results thereof; challenges and costs inherent in product marketing; the risks and uncertainties associated with economic and market conditions; risks and uncertainties associated with the Company’s business and finances in general; and other risks detailed in the Company’s filings with the U.S. Securities and Exchange Commission including its annual report on Form 10-K filed on March 12, 2013, reports on Form 10-Q and Form 8-K, and other such filings. These forward-looking statements are based on current information that may change. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and the Company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.
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TherapeuticsMD Reports Second Quarter 2013 Financial Results
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Page 4
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August 6, 2013
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CONDENSED CONSOLIDATED BALANCE SHEETS
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June 30, 2013
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December 31, 2012
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(Unaudited)
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ASSETS
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Current Assets:
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Cash
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$ | 34,435,468 | $ | 1,553,474 | ||||
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Accounts receivable, net of allowance for doubtful accounts of $100,385 and $42,048, respectively
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957,779 | 606,641 | ||||||
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Inventory
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1,506,059 | 1,615,210 | ||||||
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Other current assets
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3,607,283 | 751,938 | ||||||
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Total current assets
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40,506,589 | 4,527,263 | ||||||
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Fixed assets, net
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76,494 | 65,673 | ||||||
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Other Assets:
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Prepaid expense
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1,980,519 | 953,655 | ||||||
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Intangible assets
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345,238 | 239,555 | ||||||
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Security deposit
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156,949 | 31,949 | ||||||
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Total other assets
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2,482,706 | 1,225,159 | ||||||
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Total assets
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$ | 43,065,789 | $ | 5,818,095 | ||||
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LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
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Current Liabilities:
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Accounts payable
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$ | 2,045,116 | $ | 1,641,366 | ||||
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Deferred revenue
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1,219,072 | 1,144,752 | ||||||
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Other current liabilities
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1,334,730 | 725,870 | ||||||
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Total current liabilities
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4,598,918 | 3,511,988 | ||||||
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Long-Term Liabilities:
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Notes payable, net of debt discount of $0 and $1,102,680, respectively
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— | 3,589,167 | ||||||
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Accrued interest
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— | 150,068 | ||||||
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Total long-term liabilities
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— | 3,739,235 | ||||||
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Total liabilities
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4,598,918 | 7,251,223 | ||||||
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Commitments and Contingencies
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Stockholders’ Equity (Deficit):
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Preferred stock - par value $0.001; 10,000,000 shares authorized; no shares issued and outstanding
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— | — | ||||||
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Common stock - par value $0.001; 250,000,000 shares authorized; 131,212,706 and 99,784,982 issued and outstanding, respectively
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131,213 | 99,785 | ||||||
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Additional paid-in capital
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102,834,270 | 50,580,400 | ||||||
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Accumulated deficit
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(64,498,612 | ) | (52,113,313 | ) | ||||
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Total stockholder’ equity (deficit)
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38,466,871 | (1,433,128 | ) | |||||
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Total liabilities and stockholders’ equity (deficit)
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$ | 43,065,789 | $ | 5,818,095 | ||||
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TherapeuticsMD Reports Second Quarter 2013 Financial Results
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Page 5
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August 6, 2013
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
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Three Months Ended
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Six Months Ended
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June 30,
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June 30,
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2013
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2012
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2013
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2012
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(Unaudited)
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(Unaudited)
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(Unaudited)
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(Unaudited)
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Revenues, net
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$ | 2,080,885 | $ | 819,150 | $ | 3,618,080 | $ | 1,540,842 | ||||||||
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Cost of goods sold
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463,606 | 372,370 | 843,952 | 708,494 | ||||||||||||
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Gross profit
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1,617,279 | 446,780 | 2,774,128 | 832,348 | ||||||||||||
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Operating expenses:
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Sales, general, and administration
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5,476,553 | 3,573,485 | 10,003,135 | 6,400,535 | ||||||||||||
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Research and development
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1,747,084 | 833,342 | 3,312,285 | 1,245,303 | ||||||||||||
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Depreciation and amortization
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10,636 | 14,535 | 18,593 | 29,113 | ||||||||||||
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Total operating expense
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7,234,273 | 4,421,362 | 13,334,013 | 7,674,951 | ||||||||||||
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Operating loss
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(5,616,994 | ) | (3,974,582 | ) | (10,559,885 | ) | (6,842,603 | ) | ||||||||
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Other income (expense):
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Miscellaneous income
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3,479 | 1,554 | 3,479 | 1,554 | ||||||||||||
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Interest expense
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(150 | ) | (1,148,761 | ) | (1,165,981 | ) | (1,250,734 | ) | ||||||||
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Financing costs
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(395,981 | ) | — | (659,968 | ) | — | ||||||||||
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Loan guaranty costs
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— | (11,745 | ) | (2,944 | ) | (23,490 | ) | |||||||||
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Beneficial conversion feature
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— | (6,716,504 | ) | — | (6,716,504 | ) | ||||||||||
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Loss on extinguishment of debt
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— | — | — | (10,307,864 | ) | |||||||||||
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Total other income (expense)
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(392,652 | ) | (7,875,456 | ) | (1,825,414 | ) | (18,297,038 | ) | ||||||||
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Loss before taxes
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(6,009,646 | ) | (11,850,038 | ) | (12,385,299 | ) | (25,139,641 | ) | ||||||||
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Provision for income taxes
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— | — | — | — | ||||||||||||
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Net loss
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$ | (6,009,646 | ) | $ | (11,850,038 | ) | $ | (12,385,299 | ) | $ | (25,139,641 | ) | ||||
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Loss per share, basic and diluted:
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Net loss per share, basic and diluted
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$ | (0.05 | ) | $ | (0.14 | ) | $ | (0.11 | ) | $ | (0.29 | ) | ||||
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Weighted average number of common shares outstanding
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130,851,978 | 86,149,419 | 116,866,764 | 85,352,818 | ||||||||||||
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TherapeuticsMD Reports Second Quarter 2013 Financial Results
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Page 6
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August 6, 2013
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CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
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Six Months Ended
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June 30,
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2013
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2012
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(Unaudited)
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(Unaudited)
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CASH FLOWS FROM OPERATING ACTIVITIES
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Net loss
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$ | (12,385,299 | ) | $ | (25,139,641 | ) | ||
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Adjustments to reconcile net loss to net cash flows used in operating activities:
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Depreciation
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12,084 | 15,141 | ||||||
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Amortization of intangible assets
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6,509 | 13,972 | ||||||
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Provision for doubtful accounts
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58,337 | 15,023 | ||||||
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Amortization of debt discount
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1,102,680 | 1,109,276 | ||||||
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Stock based compensation
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1,179,912 | 529,129 | ||||||
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Amortization of deferred financing costs
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659,938 | — | ||||||
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Stock based expense for services
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637,155 | 120,120 | ||||||
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Loan guaranty costs
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2,944 | 23,490 | ||||||
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Loss on debt extinguishment
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— | 10,307,864 | ||||||
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Beneficial conversion feature
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— | 6,716,504 | ||||||
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Changes in operating assets and liabilities:
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Accounts receivable
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(409,475 | ) | (396,232 | ) | ||||
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Inventory
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109,151 | (232,168 | ) | |||||
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Other current assets
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(1,696,551 | ) | (118,566 | ) | ||||
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Other assets
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(899,000 | ) | — | |||||
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Accounts payable
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403,750 | 385,620 | ||||||
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Accrued interest
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(150,068 | ) | 133,702 | |||||
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Other current liabilities
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608,860 | 248,450 | ||||||
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Deferred revenue
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74,320 | 618,877 | ||||||
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Net cash flows used in operating activities
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(10,684,753 | ) | (5,649,439 | ) | ||||
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CASH FLOWS FROM INVESTING ACTIVITIES
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Payment of security deposit
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(125,000 | ) | — | |||||
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Patent costs, net of abandoned costs
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(112,192 | ) | (49,184 | ) | ||||
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Purchase of property and equipment
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(22,905 | ) | (66,404 | ) | ||||
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Net cash flows used in investing activities
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(260,097 | ) | (115,588 | ) | ||||
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CASH FLOWS FROM FINANCING ACTIVITIES
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Proceeds from sale of common stock, net
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48,512,460 | — | ||||||
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Proceeds from notes and loans payable
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— | 6,900,000 | ||||||
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Repayment of notes payable
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(4,691,847 | ) | (50,780 | ) | ||||
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Repayment of notes payable-related party
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— | (50,000 | ) | |||||
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Proceeds from exercise of options
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6,231 | 165,999 | ||||||
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Proceeds from line of credit
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500,000 | — | ||||||
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Repayment of line of credit
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(500,000 | ) | — | |||||
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Proceeds from sale of warrants
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— | 400 | ||||||
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Net cash flows provided by financing activities
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43,826,844 | 6,965,619 | ||||||
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Increase in cash
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32,881,994 | 1,200,592 | ||||||
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Cash, beginning of period
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1,553,474 | 126,421 | ||||||
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Cash, end of period
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34,435,468 | $ | 1,327,013 | |||||
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SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:
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Cash paid for interest
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$ | 212,853 | $ | 7,756 | ||||
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Cash paid for income taxes
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$ | — | $ | — | ||||
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SUPPLEMENTAL SCHEDULE OF NON-CASH FINANCING ACTIVITIES:
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Warrants issued for financing
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$ | 1,711,956 | $ | 2,509,537 | ||||
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Warrants issued in exchange for debt and accrued interest
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$ | — | $ | 3,102,000 | ||||
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Warrants issued for services
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$ | 462,196 | $ | 1,532,228 | ||||
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Shares issued in exchange for debt and accrued interest
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$ | — | $ | 1,054,658 | ||||
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Notes payable issued for accrued interest
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$ | — | $ | 15,123 | ||||