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TherapeuticsMD Announces Second Quarter 2017 Financial Results

16:05 EDT 3 Aug 2017 | Businesswire
TherapeuticsMD, Inc.

TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare company, today announced its financial results for the quarter ended June 30, 2017.

Second Quarter and Recent Developments

  • Net revenue for the company’s prescription prenatal vitamin business was approximately $4.3 million for the second quarter of 2017 compared with approximately $4.4 million for the second quarter of 2016.
  • Net loss was approximately $19.7 million for the second quarter of 2017, compared with approximately $21.1 million for the second quarter of 2016.
  • Ended the quarter with approximately $96.5 million in cash and no debt.
  • Participated in a Type A Post-Action Meeting on June 14, 2017 with the Division of Bone, Reproductive, and Urologic Products (DBRUP) of the FDA to discuss the Complete Response Letter (CRL) regarding the New Drug Application (NDA) for TX-004HR, the company’s investigational applicator-free estradiol vaginal softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause. The Company has formally submitted additional information for consideration related to the NDA for TX-004HR and has been informed by the FDA that it will be receiving an Advice Letter within the next week outlining the FDA’s timing of its review of the submitted additional data.
  • Pre-NDA meeting for TX-001HR, the company’s investigational bio-identical hormone therapy combination of estradiol and progesterone in a single, oral softgel for the treatment of moderate-to-severe vasomotor symptoms due to menopause, scheduled with the FDA at the end of August 2017. The company anticipates that it will submit the NDA for TX-001HR in the fourth quarter of 2017.
  • Dismissal without prejudice of the primary federal securities class action lawsuit recently filed against the company.
  • Grew the company’s intellectual property portfolio to a current total of 158 patent filings, including 82 international filings, with one allowed and 17 issued U.S. patents.

“We continue to focus on advancing our pipeline of novel hormone therapies and, if approved, bringing new, differentiated treatment options to women suffering from symptoms of menopause,” said TherapeuticsMD CEO Robert G. Finizio.

Summary of Second Quarter 2017 Financial Results

Net revenue from the company’s prescription prenatal vitamin business was approximately $4.3 million for the second quarter of 2017 compared with net revenue of approximately $4.4 million for the prior year’s quarter. These changes were primarily due to a decrease in the number of units sold.

Cost of goods sold was approximately $0.7 million for the second quarter of 2017, compared with approximately $1.1 million for the prior year’s quarter.

Total operating expenses for the second quarter of 2017 included research and development (R&D) expenses and sales, general, and administrative expenses (SG&A). R&D expenses for the second quarter of 2017 were approximately $8.7 million compared with approximately $13.8 million for the prior year’s quarter. The decrease in R&D expenses was a direct result of the completion of the REPLENISH Trial for TX-001HR. SG&A expenses for the second quarter of 2017 were approximately $14.6 million compared with approximately $10.6 million for the prior year’s quarter, primarily due to higher sales, marketing, regulatory expenditures, and personnel costs to support future commercialization.

Net loss for the second quarter of 2017 was approximately $19.7 million, or $0.10 per basic and diluted share, compared with approximately $21.1 million, or $0.11 per basic and diluted share, for the second quarter of 2016.

At June 30, 2017, cash on hand was approximately $96.5 million, compared with approximately $131.5 million at December 31, 2016.

About TherapeuticsMD, Inc.

TherapeuticsMD, 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 late stage clinical pipeline includes two phase 3 product candidates: TX-001HR for treatment of moderate-to-severe vasomotor symptoms (VMS) due to menopause and TX-004HR for treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause. The company also manufactures and distributes branded and generic prescription prenatal vitamins under the vitaMedMD® and BocaGreenMD® brands.

Forward-Looking Statements

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 resolve the deficiencies identified by the FDA in the company’s new drug application for its TX-004HR product candidate and the time frame associated with such resolution; whether the company will be able to prepare an amended NDA for its TX-004HR product candidate and, if prepared, whether the FDA will accept and approve the NDA; 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; whether the company will be able to prepare an NDA for its TX-001HR product candidate and, if prepared, whether the FDA will accept and approve the NDA; the length, cost and uncertain results of the company’s clinical trials, including any additional clinical trials that the FDA may require in connection with TX-004HR; 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.

 

THERAPEUTICSMD, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(Unaudited)

  June 30, 2017   December 31, 2016
 
 
ASSETS
Current Assets:
Cash $ 96,476,483 $ 131,534,101
Accounts receivable, net of allowance for doubtful accounts
of $358,268 and $376,374, respectively 3,396,419 4,500,699
Inventory 1,414,015 1,076,321
Other current assets   2,228,755     2,299,052  
Total current assets   103,515,672     139,410,173  
 
Fixed assets, net   483,688     516,839  
 
Other Assets:
Intangible assets, net 2,739,686 2,405,972
Security deposit   139,036     139,036  
Total other assets   2,878,722     2,545,008  
Total assets $ 106,878,082   $ 142,472,020  
 
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Accounts payable $ 8,108,034 $ 7,358,514
Other current liabilities   5,180,218     7,624,085  
Total current liabilities   13,288,252     14,982,599  
 
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 shares authorized;
204,027,142 and 196,688,222 issued and outstanding, respectively 204,027 196,688
Additional paid in capital 443,952,952 436,995,052
Accumulated deficit   (350,567,149 )   (309,702,319 )
Total stockholders' equity   93,589,830     127,489,421  
Total liabilities and stockholders' equity $ 106,878,082   $ 142,472,020  
 
 

THERAPEUTICSMD, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

             
Three Months Ended Six Months Ended
June 30, June 30,
  2017     2016     2017     2016  
 
Revenues, net $ 4,250,433 $ 4,403,247 $ 8,235,897 $ 9,333,338
 
Cost of goods sold   681,725     1,130,108     1,341,360     2,238,551  
Gross profit   3,568,708     3,273,139     6,894,537     7,094,787  
 
Operating expenses:
Sales, general, and administration 14,628,927 10,619,006 31,466,544 20,297,558
Research and development 8,716,395 13,841,193 16,441,235 28,938,210
Depreciation and amortization   53,189     24,262     102,888     43,859  
Total operating expense   23,398,511     24,484,461     48,010,667     49,279,627  
 
Operating loss   (19,829,803 )   (21,211,322 )   (41,116,130 )   (42,184,840 )
 
Other income:
Miscellaneous income 149,054 114,320 275,022 155,937
Accreted interest   3,832     2,863     7,699     5,399  
Total other income   152,886     117,183     282,721     161,336  
 
Loss before taxes (19,676,917 ) (21,094,139 ) (40,833,409 ) (42,023,504 )
 
Provision for income taxes   -     -     -     -  
 
Net loss $ (19,676,917 ) $ (21,094,139 ) $ (40,833,409 ) $ (42,023,504 )
 
Net loss per share, basic and diluted $ (0.10 ) $ (0.11 ) $ (0.20 ) $ (0.21 )
 
Weighted average number of common
shares outstanding   203,384,610     196,325,715     200,602,778     195,613,639  
 
 

THERAPEUTICSMD, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

       
Six Months Ended
June 30, 2017 June 30, 2016
 

CASH FLOWS FROM OPERATING ACTIVITIES

Net loss $ (40,833,409 ) $ (42,023,504 )

Adjustments to reconcile net loss to net cash flows used in operating activities:

Depreciation of fixed assets 69,000 19,216
Amortization of intangible assets 33,888 24,643
(Recovery of) provision for doubtful accounts (18,106 ) 447,388
Share-based compensation 3,051,357 9,200,844
Changes in operating assets and liabilities:
Accounts receivable 1,122,386 (1,874,980 )
Inventory (337,694 ) (193,503 )
Other current assets (58,601 ) 1,001,120
Accounts payable 749,520 (86,786 )
Other current liabilities   (2,443,867 )   (1,239,743 )
Net cash used in operating activities   (38,665,526 )   (34,725,305 )
 
CASH FLOWS FROM INVESTING ACTIVITIES
Patent costs (367,602 ) (393,221 )
Purchase of fixed assets (35,849 ) (265,036 )
Payment of security deposit   -     (4,864 )
Net cash used in investing activities   (403,451 )   (663,121 )
 
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from sale of common stock, net of costs - 134,863,475
Proceeds from exercise of warrants 3,798,999 1,373,000
Proceeds from exercise of options   212,360     978,042  
Net cash provided by financing activities   4,011,359     137,214,517  
 
(Decrease) increase in cash (35,057,618 ) 101,826,091
Cash, beginning of period   131,534,101     64,706,355  
Cash, end of period $ 96,476,483   $ 166,532,446  
 

TherapeuticsMD, Inc.
David DeLucia, 561-961-1900
Director, Investor Relations
David.DeLucia@TherapeuticsMD.com

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