TherapeuticsMD, Inc. 8-K

Exhibit 99.1

 

 

FOR IMMEDIATE RELEASE

 

 

TherapeuticsMD Announces Third Quarter 2017 Financial Results

 

- Resubmission of New Drug Application for TX-004HR expected in the coming weeks -

 

- Submission of New Drug Application for TX-001HR expected in December 2017 -

 

BOCA RATON, Fla. November 6, 2017 – TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women’s healthcare company, today announced its financial results for the quarter ended September 30, 2017.

 

Third Quarter and Recent Developments

 

On November 3, 2017, the Company participated in an in-person meeting with the Division of Bone, Reproductive, and Urologic Products of the Food and Drug Administration (FDA). At the meeting, the Division agreed to the resubmission of the New Drug Application (NDA) for TX-004HR without the need for an additional pre-approval study. The Company will commit to conduct a post-approval observational study. The Company plans to resubmit the NDA for TX-004HR in the coming weeks.
Presented five oral abstracts at NAMS 2017 reviewing data from the Replenish Trial, a phase 3 clinical trial of 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. The results from the trial in 1,835 postmenopausal women demonstrated that multiple doses of TX-001HR resulted in a statistically significant and clinically meaningful reduction from baseline in both the frequency and severity of hot flashes compared to placebo. The Company plans to submit the NDA for TX-001HR in December 2017.
Net revenue for the company’s prescription prenatal vitamin business was approximately $4.4 million for the third quarter of 2017 compared with approximately $5.5 million for the third quarter of 2016.
Net loss was approximately $14.7 million for the third quarter of 2017, compared with approximately $25.0 million for the third quarter of 2016.
Ended the quarter with approximately $148.3 million in cash and no debt, which includes approximately $68.6 million in net proceeds from an equity offering in September 2017.
Grew the company’s intellectual property portfolio to a current total of 158 patent filings, including 82 international filings, with one allowed and 18 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 Third Quarter 2017 Financial Results

 

Net revenue from the company’s prescription prenatal vitamin business was approximately $4.4 million for the third quarter of 2017 compared with net revenue of approximately $5.5 million for the prior year’s quarter. These changes were primarily due to a decrease in the average net sales price of our products and a slight decrease in the number of units sold.

 

 
 

 

Cost of goods sold was approximately $0.7 million for the third quarter of 2017, compared with approximately $1.2 million for the prior year’s quarter.

 

Total operating expenses for the third quarter of 2017 included research and development (R&D) expenses and sales, general, and administrative expenses (SG&A). R&D expenses for the third quarter of 2017 were approximately $6.4 million compared with approximately $14.7 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 third quarter of 2017 were approximately $12.1 million compared with approximately $14.7 million for the prior year’s quarter, primarily due to lower sales and marketing expenditures.

 

Net loss for the third quarter of 2017 was approximately $14.7 million, or $0.07 per basic and diluted share, compared with approximately $25.0 million, or $0.13 per basic and diluted share, for the third quarter of 2016.

 

At September 30, 2017, cash on hand was approximately $148.3 million, which includes approximately $68.6 million in net proceeds from an equity offering in September 2017, 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

 

   September 30, 2017  December 31, 2016
   (Unaudited)   
       
ASSETS
Current Assets:          
Cash  $148,292,654   $131,534,101 
Accounts receivable, net of allowance for doubtful accounts          
  of $377,929 and $376,374, respectively   4,392,635    4,500,699 
Inventory   1,293,517    1,076,321 
Other current assets   3,001,777    2,299,052 
     Total current assets   156,980,583    139,410,173 
           
Fixed assets, net   448,066    516,839 
           
Other Assets:          
Intangible assets, net   2,793,421    2,405,972 
Security deposit   139,036    139,036 
     Total other assets   2,932,457    2,545,008 
       Total assets  $160,361,106   $142,472,020 
           
 LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:          
Accounts payable  $4,199,369   $7,358,514 
Other current liabilities   6,677,232    7,624,085 
     Total current liabilities   10,876,601    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;          
  216,429,642 and 196,688,222 issued and outstanding, respectively   216,430    196,688 
Additional paid in capital   514,499,865    436,995,052 
Accumulated deficit   (365,231,790)   (309,702,319)
     Total stockholders’ equity   149,484,505    127,489,421 
       Total liabilities and stockholders’ equity  $160,361,106   $142,472,020 

 

 
 

 

THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)

 

  Three Months Ended  Nine Months Ended
  September 30,  September 30,
   2017  2016  2017  2016
                     
Revenues, net  $4,417,598   $5,535,685   $12,653,495   $14,869,023 
Cost of goods sold   700,814    1,237,446    2,042,174    3,475,997 
Gross profit   3,716,784    4,298,239    10,611,321    11,393,026 
Operating expenses:                    
Sales, general, and administration   12,057,868    14,721,710    43,524,412    35,019,268 
Research and development   6,436,802    14,664,123    22,878,037    43,602,333 
Depreciation and amortization   54,055    40,460    156,943    84,319 
     Total operating expense   18,548,725    29,426,293    66,559,392    78,705,920 
Operating loss   (14,831,941)   (25,128,054)   (55,948,071)   (67,312,894)
                     
Other income:                    
Miscellaneous income   167,300    109,942    442,322    265,879 
Accreted interest   —      2,451    7,699    7,850 
     Total other income   167,300    112,393    450,021    273,729 
Loss before taxes   (14,664,641)   (25,015,661)   (55,498,050)   (67,039,165)
Provision for income taxes                
Net loss  $(14,664,641)  $(25,015,661)  $(55,498,050)  $(67,039,165)
Net loss per share, basic and diluted  $(0.07)  $(0.13)  $(0.27)  $(0.34)
                     
Weighted average number of common                    
  shares outstanding   207,938,338    196,502,327    203,282,335    195,912,173 

 

 
 

 

THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)

 

  Nine Months Ended
  September 30,
2017
  September 30,
2016
           
CASH FLOWS FROM OPERATING ACTIVITIES          
  Net loss  $(55,498,050)  $(67,039,165)
     Adjustments to reconcile net loss to net cash flows used in          
        operating activities:          
          Depreciation of fixed assets   104,622    45,759 
          Amortization of intangible assets   52,321    38,560 
          Provision for doubtful accounts   1,555    2,261,568 
          Share-based compensation   5,037,783    13,385,215 
          Changes in operating assets and liabilities:          
             Accounts receivable   106,509    (4,245,151)
             Inventory   (217,196)   (153,245)
             Other current assets   (831,623)   379,930 
             Accounts payable   (3,159,145)   1,098,245 
             Other current liabilities   (946,853)   703,895 
Net cash used in operating activities   (55,350,077)   (53,524,389)
           
CASH FLOWS FROM INVESTING ACTIVITIES          
  Patent costs   (439,770)   (541,686)
  Purchase of fixed assets   (35,849)   (307,714)
  Payment of security deposit   —      (14,036)
Net cash used in investing activities   (475,619)   (863,436)
           
CASH FLOWS FROM FINANCING ACTIVITIES          
  Proceeds from sale of common stock, net of costs   68,572,635    134,863,475 
  Proceeds from exercise of warrants   3,798,999    1,373,000 
  Proceeds from exercise of options   212,615    979,060 
Net cash provided by financing activities   72,584,249    137,215,535 
           
Increase in cash   16,758,553    82,827,710 
Cash, beginning of period   131,534,101    64,706,355 
Cash, end of period  $148,292,654   $147,534,065 

 

 
 


The following information was filed by Therapeuticsmd, Inc. (TXMD) on Monday, November 6, 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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