TherapeuticsMD, Inc. 8-K

Exhibit 99.1

FOR IMMEDIATE RELEASE

TherapeuticsMD Announces Second Quarter 2017 Financial Results

BOCA RATON, Fla. August 3, 2017 – 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.

# # #

Investor Contact

David DeLucia

Director, Investor Relations

561-961-1900
David.DeLucia@TherapeuticsMD.com

 

 
 

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 

 

 

 


The following information was filed by Therapeuticsmd, Inc. (TXMD) on Thursday, August 3, 2017 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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