TherapeuticsMD, Inc. 8-K

 

Exhibit 99.1

 

FOR IMMEDIATE RELEASE

 

 

TherapeuticsMD Announces First Quarter 2017 Financial Results

 

BOCA RATON, Fla. May 2, 2017 – TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare company, today announced its financial results for the quarter ended March 31, 2017.

 

First Quarter and Recent Developments

 

  Net revenue for the company’s prescription prenatal vitamin business was approximately $4.0 million for the first quarter of 2017 compared with approximately $4.9 million for the first quarter of 2016.
  Net loss was approximately $21.2 million for the first quarter of 2017, compared with approximately $20.9 million for the first quarter of 2016.
  Ended the quarter with approximately $113.5 million in cash and no debt.
  Anticipate FDA action on the New Drug Application (NDA) for TX-004HR on or before the originally scheduled Prescription Drug User Fee Act (PDUFA) target action date of May 7, 2017. TX-004HR is 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.
  Presented two posters at ENDO 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 as early as the third quarter of 2017.
  Launched BIO-IGNITETM, an outreach program to quantify the number of compounded bio-identical estradiol and progesterone prescriptions currently dispensed by the 3,000-3,500 high-volume compounding pharmacies and qualify their interests in distributing the company’s bio-identical hormone product candidates, if approved. Through the BIO-IGNITETM program, the company currently has a distribution agreement with Premier Value Pharmacy Compounding Network (PVPCN), representing over 300 pharmacies and 1.5 million annual prescriptions of compounded bio-identical estradiol and progesterone (E+P), to dispense the company’s products in lieu of compounding, if approved.  The company has also received prescription data from over 400 additional pharmacies, representing over 500,000 annual prescriptions of compounded bio-identical E+P.
  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 are focused 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 First Quarter 2017 Financial Results

 

Net revenue from the company’s prescription prenatal vitamin business was approximately $4.0 million for the first quarter of 2017 compared with net revenue of approximately $4.9 million for the prior year’s quarter. These changes were primarily due to a decrease in the average net sales price of our products, partially offset by an increase in the number of units sold.

 

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

 

Total operating expenses for the first quarter of 2017 included research and development (R&D) expenses and sales, general, and administrative expenses (SG&A). R&D expenses during the first quarter of 2017 were approximately $7.7 million compared with approximately $15.1 million for the prior year’s quarter. The decrease in R&D was a direct result of the completion of the Replenish Trial for TX-001HR. SG&A expenses for the first quarter of 2017 were approximately $16.8 million compared with approximately $9.7 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 first quarter of 2017 was approximately $21.2 million, or $0.11 per basic and diluted share, compared with approximately $20.9 million, or $0.11 per basic and diluted share, for the first quarter of 2016.

 

At March 31, 2017, cash on hand was approximately $113.5 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 NDA for its TX-004HR product candidate; whether the FDA will approve the company’s new drug application for its TX-004HR product candidate and whether any such approval will occur by the PDUFA date; 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; 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

 

Media Contact

 

Ami Knoefler

SparkBioComm

650-739-9952

Ami@SparkBioComm.com

 

 
 

  

THERAPEUTICSMD, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

 

    March 31, 2017     December 31, 2016  
    (Unaudited)        
             
ASSETS  
Current Assets:                
Cash   $ 113,525,419     $ 131,534,101  
Accounts receivable, net of allowance for doubtful accounts of $374,771 and $376,374, respectively     3,921,359       4,500,699  
Inventory     1,338,618       1,076,321  
Other current assets     2,488,121       2,299,052  
Total current assets     121,273,517       139,410,173  
                 
Fixed assets, net     511,073       516,839  
                 
Other Assets:                
Intangible assets, net     2,497,360       2,405,972  
Security deposit     139,036       139,036  
Total other assets     2,636,396       2,545,008  
Total assets   $ 124,420,986     $ 142,472,020  
                 
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:                
Accounts payable   $ 6,146,278     $ 7,358,514  
Other current liabilities     7,940,723       7,624,085  
Total current liabilities     14,087,001       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:                
198,593,268 and 196,688,222 issued and outstanding, respectively     198,593       196,688  
Additional paid-in capital     441,025,624       436,995,052  
Accumulated deficit     (330,890,232 )     (309,702,319 )
Total stockholders’ equity     110,333,985       127,489,421  
Total liabilities and stockholders’ equity   $ 124,420,986     $ 142,472,020  

 

 

 
 

 

THERAPEUTICSMD, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited) 

 

    Three Months Ended
    March 31, 2017    March 31, 2016 
           
Revenues, net  $3,985,464   $4,930,091 
           
Cost of goods sold   659,635    1,108,443 
           
Gross profit   3,325,829    3,821,648 
           
Operating expenses:          
Sales, general, and administrative   16,837,617    9,678,552 
Research and development   7,724,840    15,097,017 
Depreciation and amortization   49,699    19,597 
     Total operating expenses   24,612,156    24,795,166 
           
Operating loss   (21,286,327)   (20,973,518)
           
Other income          
Miscellaneous income   125,968    41,617 
Accreted interest   3,867    2,536 
     Total other income   129,835    44,153 
           
Loss before income taxes   (21,156,492)   (20,929,365)
           
Provision for income taxes   —      —   
Net loss  $(21,156,492)  $(20,929,365)
           
Loss per share, basic and diluted:          
           
Net loss per share, basic and diluted  $(0.11)  $(0.11)
           
Weighted average number of common          
  shares outstanding, basic and diluted   197,790,040    194,901,560 

  

 
 

 

THERAPEUTICSMD, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited) 

  

    Three Months Ended 
    March 31, 2017    March 31, 2016 
           
CASH FLOWS FROM OPERATING ACTIVITIES          
  Net loss  $(21,156,492)  $(20,929,365)
     Adjustments to reconcile net loss to net cash used in          
        operating activities:          
          Depreciation   33,600    8,363 
          Amortization of intangible assets   16,099    11,234 
           (Recovery of) provision for doubtful accounts   (1,603)   236,151 
          Share-based compensation   1,413,195    4,381,690 
          Changes in operating assets and liabilities:          
             Accounts receivable   580,943    (2,250,209)
             Inventory   (262,297)   (267,281)
             Other current assets   (253,518)   477,312 
             Other assets   —      (2,536)
             Accounts payable   (1,212,236)   304,475 
             Other current liabilities   316,638    (1,373,762)
           
Net cash used in operating activities   (20,525,671)   (19,403,928)
           
CASH FLOWS FROM INVESTING ACTIVITIES          
  Patent costs   (107,487)   (90,529)
  Purchase of fixed assets   (27,834)   (74,478)
           
Net cash used in investing activities   (135,321)   (165,007)
           
CASH FLOWS FROM FINANCING ACTIVITIES          
  Proceeds from sale of common stock, net of costs   —      134,863,475 
  Proceeds from exercise of options   192,310    786,450 
  Proceeds from exercise of warrants   2,460,000    1,310,000 
           
Net cash provided by financing activities   2,652,310    136,959,925 
           
(Decrease) increase in cash   (18,008,682)   117,390,990 
Cash, beginning of period   131,534,101    64,706,355 
Cash, end of period  $113,525,419   $182,097,345 

 


The following information was filed by Therapeuticsmd, Inc. (TXMD) on Tuesday, May 2, 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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