TherapeuticsMD Reports Second Quarter 2013 Financial Results

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:
  • Net revenue for the quarter ended June 30, 2013 was $2.1 million compared with $819 thousand in the second quarter of 2012;
  • 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;
  • 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
  • TXMD was added to the Russell 2000® on June 28, 2013.

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.

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.

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.
   
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
 
June 30, 2013 December 31, 2012
(Unaudited)
ASSETS
Current Assets:
Cash $ 34,435,468 $ 1,553,474

Accounts receivable, net of allowance fordoubtful accounts of $100,385 and $42,048,respectively
957,779 606,641
Inventory 1,506,059 1,615,210
Other current assets   3,607,283     751,938  
Total current assets   40,506,589     4,527,263  
 
Fixed assets, net   76,494     65,673  
 
Other Assets:
Prepaid expense 1,980,519 953,655
Intangible assets 345,238 239,555
Security deposit   156,949     31,949  
Total other assets   2,482,706     1,225,159  
 
Total assets $ 43,065,789   $ 5,818,095  
 
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
Current Liabilities:
Accounts payable $ 2,045,116 $ 1,641,366
Deferred revenue 1,219,072 1,144,752
Other current liabilities   1,334,730     725,870  
Total current liabilities   4,598,918     3,511,988  
 
Long-Term Liabilities:

Notes payable, net of debt discount of$0 and $1,102,680, respectively
- 3,589,167
Accrued interest   -     150,068  
Total long-term liabilities   -     3,739,235  
 
Total liabilities   4,598,918     7,251,223  
 
Commitments and Contingencies
 
Stockholders' Equity (Deficit):

Preferred stock - par value $0.001; 10,000,000 sharesauthorized; no shares issued and outstanding
- -

Common stock - par value $0.001; 250,000,000 sharesauthorized; 131,212,706 and 99,784,982 issuedand outstanding, respectively
131,213 99,785
Additional paid-in capital 102,834,270 50,580,400
Accumulated deficit   (64,498,612 )   (52,113,313 )
Total stockholder' equity (deficit)   38,466,871     (1,433,128 )
 
Total liabilities and stockholders' equity (deficit) $ 43,065,789   $ 5,818,095  
 
       
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
 
Three Months Ended Six Months Ended
June 30, June 30,
2013 2012 2013 2012
(Unaudited) (Unaudited) (Unaudited) (Unaudited)
 
Revenues, net $ 2,080,885 $ 819,150 $ 3,618,080 $ 1,540,842
 
Cost of goods sold   463,606     372,370     843,952     708,494  
 
Gross profit   1,617,279     446,780     2,774,128     832,348  
 
Operating expenses:
Sales, general, and administration 5,476,553 3,573,485 10,003,135 6,400,535
Research and development 1,747,084 833,342 3,312,285 1,245,303
Depreciation and amortization   10,636     14,535     18,593     29,113  
Total operating expense   7,234,273     4,421,362     13,334,013     7,674,951  
 
Operating loss   (5,616,994 )   (3,974,582 )   (10,559,885 )   (6,842,603 )
 
Other income (expense):
Miscellaneous income 3,479 1,554 3,479 1,554
Interest expense (150 ) (1,148,761 ) (1,165,981 ) (1,250,734 )
Financing costs (395,981 ) - (659,968 ) -
Loan guaranty costs - (11,745 ) (2,944 ) (23,490 )
Beneficial conversion feature - (6,716,504 ) - (6,716,504 )
Loss on extinguishment of debt   -     -     -     (10,307,864 )
Total other income (expense)   (392,652 )   (7,875,456 )   (1,825,414 )   (18,297,038 )
 
Loss before taxes (6,009,646 ) (11,850,038 ) (12,385,299 ) (25,139,641 )
 
Provision for income taxes   -     -     -     -  
 
Net loss $ (6,009,646 ) $ (11,850,038 ) $ (12,385,299 ) $ (25,139,641 )
 
Loss per share, basic and diluted:
 
Net loss per share, basic and diluted $ (0.05 ) $ (0.14 ) $ (0.11 ) $ (0.29 )
 
Weighted average number of common
shares outstanding   130,851,978     86,149,419     116,866,764     85,352,818  
 
   
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
 
Six Months Ended
June 30,
2013 2012
(Unaudited) (Unaudited)
 
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss $ (12,385,299 ) $ (25,139,641 )
Adjustments to reconcile net loss to net cash flows used in
operating activities:
Depreciation 12,084 15,141
Amortization of intangible assets 6,509 13,972
Provision for doubtful accounts 58,337 15,023
Amortization of debt discount 1,102,680 1,109,276
Stock based compensation 1,179,912 529,129
Amortization of deferred financing costs 659,938 -
Stock based expense for services 637,155 120,120
Loan guaranty costs 2,944 23,490
Loss on debt extinguishment - 10,307,864
Beneficial conversion feature - 6,716,504
Changes in operating assets and liabilities:
Accounts receivable (409,475 ) (396,232 )
Inventory 109,151 (232,168 )
Other current assets (1,696,551 ) (118,566 )
Other assets (899,000 ) -
Accounts payable 403,750 385,620
Accrued interest (150,068 ) 133,702
Other current liabilities 608,860 248,450
Deferred revenue   74,320     618,877  
 
Net cash flows used in operating activities   (10,684,753 )   (5,649,439 )
 
CASH FLOWS FROM INVESTING ACTIVITIES
Payment of security deposit (125,000 ) -
Patent costs, net of abandoned costs (112,192 ) (49,184 )
Purchase of property and equipment   (22,905 )   (66,404 )
 
Net cash flows used in investing activities   (260,097 )   (115,588 )
 
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from sale of common stock, net 48,512,460 -
Proceeds from notes and loans payable - 6,900,000
Repayment of notes payable (4,691,847 ) (50,780 )
Repayment of notes payable-related party - (50,000 )
Proceeds from exercise of options 6,231 165,999
Proceeds from line of credit 500,000 -
Repayment of line of credit (500,000 ) -
Proceeds from sale of warrants   -     400  
 
Net cash flows provided by financing activities   43,826,844     6,965,619  
 
Increase in cash 32,881,994 1,200,592
Cash, beginning of period   1,553,474     126,421  
Cash, end of period   34,435,468   $ 1,327,013  
 
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:
 
Cash paid for interest $ 212,853   $ 7,756  
 
Cash paid for income taxes $ -   $ -  
 
SUPPLEMENTAL SCHEDULE OF NON-CASH FINANCING ACTIVITIES:
 
Warrants issued for financing $ 1,711,956   $ 2,509,537  
 
Warrants issued in exchange for debt and accrued interest $ -   $ 3,102,000  
 
Warrants issued for services $ 462,196   $ 1,532,228  
 
Shares issued in exchange for debt and accrued interest $ -   $ 1,054,658  
 
Notes payable issued for accrued interest $ -   $ 15,123  
 

Copyright Business Wire 2010

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