EX-99.1 2 ex99-1.htm PRESS RELEASE

 

TherapeuticsMD, Inc. 8-K

 

Exhibit 99.1

 

 

FOR IMMEDIATE RELEASE

 

 

TherapeuticsMD Announces Third Quarter 2015 Financial Results

 

– Topline phase 3 data anticipated in fourth quarter for TX-004HR to treat symptoms of VVA –

 

– Completed enrollment in phase 3 Replenish Trial for first potential FDA-approved

bio-identical oral combination hormone therapy –

 

– Management to host conference call today at 4:30 p.m. EST –

 

BOCA RATON, Fla. – November 4, 2015 – TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare company, today announced its third quarter financial results for the period ended September 30, 2015.

 

Recent and Third Quarter Developments

 

•Revenues, net for the company’s prescription prenatal vitamin business increased to approximately $5.2 million for the third quarter of 2015 compared with approximately $4.2 million for the third quarter of 2014.
•Net loss was approximately $19.5 million for the third quarter of 2015, compared with approximately $17.8 million for the third quarter of 2014, reflecting the costs of two phase 3 clinical trials for the company’s novel hormone therapy drug candidates.
•Completed last patient visit in the Rejoice Trial, a phase 3 clinical trial of TX-004HR, an applicator-free vaginal estradiol softgel drug candidate for the treatment of moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause.
•Completed patient enrollment in the Replenish Trial, a phase 3 clinical trial of TX-001HR, a combination estradiol and progesterone drug candidate, for the treatment of moderate to severe vasomotor symptoms due to menopause.
•Ended the quarter with approximately $81.1 million in cash and no debt.
•Grew the company’s intellectual property portfolio to a current total of 111 patent filings, including 61 international filings, with two allowed and 13 issued U.S. patents.
•Supported scientific abstracts and presentations at the annual meeting of the North American Menopause Society.
•Continued to develop relationships with key medical, pharmacy, patient and industry organizations.

 

“As we pursue our mission to address women’s health needs, we believe that there is a unique confluence of factors evolving on the scientific, regulatory, legislative and commercial fronts that will help us to make significant progress toward delivering on our vision and strategy,” said TherapeuticsMD CEO Robert G. Finizio. “We continue to execute both commercially and in R&D, including completion of enrollment in our Replenish Trial of TX-001HR, our combination estradiol and progesterone drug candidate for treatment of moderate to severe vasomotor symptoms due to menopause. We also expect topline data from our Rejoice Trial of TX-004HR for dyspareunia associated with VVA by the end of this year. The market need for our products is large and growing, and we are building key alliances with healthcare providers, women’s health advocates and industry organizations.”

 

 

 
 

Third Quarter Financial Results Summary

 

Revenues, net for the third quarter of 2015 increased by 24 percent to approximately $5.2 million compared with revenues, net of approximately $4.2 million for the prior year’s quarter. Revenue growth during the third quarter was primarily driven by increased number of units sold, product mix, and average net sales price of the company’s prenatal vitamin products.

 

Cost of goods sold increased to approximately $1.2 million for the three months ended September 30, 2015, compared with approximately $1.1 million in the prior year’s quarter.

 

Total operating expenses for the third quarter of 2015 included research and development (R&D) expenses and sales, general and administration (SG&A). R&D expenses for the third quarter of 2015 were approximately $16.4 million compared with approximately $14.9 million for the prior year’s quarter. The increase in R&D expense was primarily due to an increase in scale-up and manufacturing activities for the company’s phase 3 drugs in development, which was partially offset by lower clinical trial costs. SG&A expenses for the third quarter of 2015 were approximately $7.0 million compared with approximately $6.0 million for the third quarter of 2014, primarily as a result of increases in human resources costs and professional fees, which were partially offset by a decrease in marketing costs.

 

Non-operating income remained insignificant for the third quarter of 2015 and 2014 and included miscellaneous and interest income for both periods.

 

Net loss for the third quarter of 2015 was approximately $19.5 million, or $0.11 per basic and diluted share, compared with approximately $17.8 million, or $0.12 per basic and diluted share, for the third quarter of 2014.

 

At September 30, 2015, TherapeuticsMD had cash on hand of approximately $81.1 million, compared with approximately $51.4 million at December 31, 2014.

 

Conference Call Today

 

As previously announced, TherapeuticsMD will host a conference call today to discuss these financial results and provide a business update. Details for the call are:

 

Date:   Wednesday, November 4, 2015
Time:   4:30 p.m. EST
Telephone Access (US):   866-665-9531
Telephone Access (International):   724-987-6977
Access Code for All Callers:   61714687

 

Additionally, a live webcast can be accessed on the company’s website, www.therapeuticsmd.com, on the “Home Page” or under the “Investor” section.

 

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 clinical development pipeline includes two phase 3 products. The company also manufactures and distributes branded and generic prescription prenatal vitamins as well as over-the-counter vitamins under the vitaMedMD® and BocaGreenMD® brands. More information is available at the following websites: www.therapeuticsmd.com, www.vitamedmd.com, www.vitamedmdrx.com and www.bocagreenmd.com.

 

 

 
 

 

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 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; 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.

 

# # #

 

Contacts

 

Investors:

Dan Cartwright
Chief Financial Officer

561-961-1900

Dan.Cartwright@TherapeuticsMD.com

 

 

 

 
 

 

THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
 
   September 30, 2015  December 31, 2014
   (Unaudited)   
       
ASSETS
Current Assets:          
Cash  $81,123,988   $51,361,607 
Accounts receivable, net of allowance for doubtful accounts          
  of $96,916 and $59,753, respectively   3,666,586    2,154,217 
Inventory   870,059    1,182,113 
Other current assets   2,120,805    1,537,407 
     Total current assets   87,781,438    56,235,344 
           
Fixed assets, net   56,748     63,293 
           
Other Assets:          
Prepaid expense   1,172,051    1,427,263 
Intangible assets, net   1,324,284    1,228,588 
Security deposit   125,000    125,000 
     Total other assets   2,621,335    2,780,851 
       Total assets  $90,459,521   $59,079,488 
          
 LIABILITIES AND STOCKHOLDERS' EQUITY 
Current Liabilities:          
Accounts payable  $5,301,625   $6,327,129 
Other current liabilities   6,386,777    3,840,639 
Deferred revenue   —      522,613 
     Total current liabilities   11,688,402    10,690,381 
Long-Term Liabilities:          
Accrued expenses   1,213,874    —   
       Total liabilities   12,902,276    10,690,381 
           
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 and 250,000,000 shares          
 authorized;  177,787,927 and 156,097,019 issued and outstanding, respectively   177,788    156,097 
Additional paid-in capital   279,723,640    182,982,846 
Accumulated deficit   (202,344,183)   (134,749,836)
     Total stockholders' equity   77,557,245    48,389,107 
       Total liabilities and stockholders' equity  $90,459,521   $59,079,488 

 

 
 

 

 

THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS

 

 

  

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

   2015  2014  2015  2014
   (Unaudited)  (Unaudited)  (Unaudited)  (Unaudited)
                     
Revenues, net  $5,190,175   $4,186,261   $14,513,158   $10,768,572 
                     
Cost of goods sold   1,193,965    1,068,605    3,270,695    2,792,268 
                     
Gross profit   3,996,210    3,117,656    11,242,463    7,976,304 
                     
Operating expenses:                    
Sales, general, and administration   7,060,944    6,043,354    20,089,998    16,610,015 
Research and development   16,421,753    14,909,430    58,789,302    29,052,149 
Depreciation and amortization   16,548    12,747    44,400    39,909 
     Total operating expenses   23,499,245    20,965,531    78,923,700    45,702,073 
                     
Operating loss   (19,503,035)   (17,847,875)   (67,681,237)   (37,725,769)
                     
Other income (expense):                    
Miscellaneous income   27,630    6,260    71,728    43,411 
Interest income   2,760    9,364    15,162    27,756 
Financing costs   —      —      —      (260,027)
     Total other income (expense)   30,390    15,624    86,890    (188,860)
                     
Loss before income taxes   (19,472,645)   (17,832,251)   (67,594,347)   (37,914,629)
                     
Provision for income taxes   —      —      —      —   
                     
Net loss  $(19,472,645)  $(17,832,251)  $(67,594,347)  $(37,914,629)
                     
Loss  per share, basic and diluted:                    
                     
Net loss per share, basic and diluted  $(0.11)  $(0.12)  $(0.39)  $(0.26)
                     
Weighted average number of common                    
  shares outstanding, basic and diluted   177,206,168    152,200,455    171,589,595    147,594,810 

 

 

 

 
 

 

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

 

 

   Nine Months Ended
   September 30, 2015  September 30, 2014
       
CASH FLOWS FROM OPERATING ACTIVITIES          
  Net loss  $(67,594,347)  $(37,914,629)
     Adjustments to reconcile net loss to net cash used in          
        operating activities:          
          Depreciation   22,104    22,713 
          Amortization of intangible assets   22,296    17,196 
          Provision for doubtful accounts   37,163    2,594 
          Share-based compensation   4,740,906    3,934,836 
          Amortization of deferred financing costs   —      260,027 
          Changes in operating assets and liabilities:          
             Accounts receivable   (1,549,532)   (460,565)
             Inventory   312,054    31,673 
             Other current assets   (621,923)   197,569 
             Other assets   (15,162)   (17,069)
             Accounts payable   (1,025,504)   3,534,462 
             Deferred revenue   (522,613)   (754,431)
             Other current liabilities   2,546,138    909,890 
             Long term accrued expenses   1,213,874    —   
           
Net cash used in operating activities   (62,434,546)   (30,235,734)
           
CASH FLOWS FROM INVESTING ACTIVITIES          
  Patent costs   (117,992)   (193,349)
  Purchase of property and equipment   (15,559)   (30,962)
           
Net cash used in investing activities   (133,551)   (224,311)
           
CASH FLOWS FROM FINANCING ACTIVITIES          
  Proceeds from sale of common stock, net of costs   91,374,649    42,771,353 
  Proceeds from exercise of options   589,829    315,546 
  Proceeds from exercise of warrants   366,000    181,000 
           
Net cash provided by financing activities   92,330,478    43,267,899 
           
Increase in cash   29,762,381    12,807,854 
Cash, beginning of period   51,361,607    54,191,260 
Cash, end of period  $81,123,988   $66,999,114