EX-99.1 2 ex99-1.htm PRESS RELEASE
 

TherapeuticsMD, Inc. 8-K

 

Exhibit 99.1

 

 

 

FOR IMMEDIATE RELEASE

 

 

TherapeuticsMD Announces First Quarter 2016 Financial Results

 

- NDA filing for TX-004HR planned by end of June 2016 -

 

- Strong cash position of approximately $182 million to advance pipeline products -

 

 

BOCA RATON, Fla. – May 3, 2016 – TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare company, today announced its first quarter financial results for the quarter ended March 31, 2016.

 

First Quarter and Recent Developments

 

·Net revenue from the company’s prescription prenatal vitamin business increased 10 percent to approximately $4.9 million for the first quarter of 2016, compared with approximately $4.5 million for the first quarter of 2015.

 

·Net loss was approximately $21.0 million for the first quarter of 2016, compared with approximately $20.9 million for the first quarter of 2015.

 

·Ended the quarter with approximately $182.1 million in cash and no debt.

 

·Presented posters at ENDO 2016 and the International Society for the Study of Women’s Sexual Health (ISSWSH) Annual Meeting 2016 detailing results of the phase 3 Rejoice Trial for Yuvvexy, the conditionally approved trade name for TX-004HR, an applicator-free vaginal estradiol softgel drug candidate 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 findings showed patients treated with Yuvvexy achieved a statistically significant improvement over placebo across all four co-primary endpoints at all three doses evaluated. A New Drug Application filing is planned for Yuvvexy by end of June 2016.

 

·Exited approximately 1,500 of the 1,750 patients enrolled 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. Topline results are currently anticipated late in the fourth quarter of 2016.

 

·Launched VitaTrue™, the first certified vegan and kosher prescription prenatal multivitamin, which expands the company’s line of prescription prenatal vitamin products and further strengthens its women’s health capabilities.

 

·Grew the company’s intellectual property portfolio to a current total of 134 patent filings, including 72 international filings, with 17 issued U.S. patents.

 

·Strengthened relationships with key medical, pharmacy, patient and industry organizations worldwide.

 

“During the first quarter, we successfully executed on our goals across the company,” said TherapeuticsMD CEO Robert G. Finizio. “We presented detailed phase 3 data from the Rejoice Trial at multiple conferences, and we are preparing to file our NDA for TX-004HR, the first of our two novel pipeline candidates in development to treat symptoms of menopause. We also expect topline data late in the fourth quarter of 2016 from our Replenish Trial for TX-001HR. We remain optimistic about the potential of our pipeline products and intend to leverage them, along with our current commercial infrastructure, to establish a leadership position in women’s health.”

 

 
 

 

Summary of First Quarter 2016 Financial Results

 

For the quarter ended March 31, 2016, net revenue from the company’s prescription prenatal vitamins was approximately $4.9 million compared with net revenue of approximately $4.5 million for the prior year’s quarter. Revenue growth during the quarter was primarily driven by an increase in the number of units sold and an increase in the average sales price of the company’s prenatal vitamin products, partially offset by the impact of annual changes in insurance plans.

 

Cost of goods sold was approximately $1.1 million for the three months ended March 31, 2016, compared with approximately $1.0 million in the prior year’s quarter.

 

Total operating expenses for the first quarter of 2016 included research and development (R&D) expenses and sales, general and administrative expenses (SG&A). R&D expenses during the first quarter of 2016 were approximately $15.1 million compared to approximately $18.2 million during the prior year’s quarter, reflecting a decline in the company’s clinical trial costs, partially offset by an increase in scale-up and manufacturing activities to support commercialization. SG&A expenses for the first quarter of 2016 were approximately $9.7 million compared with approximately $6.2 million for the prior year’s quarter, primarily due to an increase in share-based compensation expense.

 

Non-operating income was insignificant for the first quarter of both 2016 and 2015 and included primarily interest income for both periods.

 

Net loss for the first quarter of 2016 was approximately $21.0 million, or $0.11 per basic and diluted share, compared with approximately $20.9 million, or $0.13 per basic and diluted share, for the first quarter of 2015.

 

At March 31, 2016, cash on hand was approximately $182.1 million, compared with approximately $64.7 million at December 31, 2015.

 

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: Tuesday, May 3, 2016
Time: 4:30 p.m. EDT
Telephone Access (US): 866-665-9531
Telephone Access (International): 724-987-6977
Access Code for All Callers: 88600937

 

Additionally, a live webcast can be accessed on the company’s website, www.therapeuticsmd.com, on the Home Page or under the “Investors & Media” section. A digital recording of the conference call will be available for replay beginning two hours after the call's completion and for at least 30 days with the dial-in 855-859-2056 or international 404-537-3406 and Conference ID: 45870409.

 

 
 

 

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

 

 

David Delucia

Director of Investor Relations

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

 

 
 

 

THERAPEUTICSMD, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

 

   March 31, 2016  December 31, 2015
   (Unaudited)   
       
ASSETS
Current Assets:   
Cash  $182,097,345   $64,706,355 
Accounts receivable, net of allowance for doubtful
     accounts of $318,061 and $81,910, respectively		   5,063,773    3,049,715 
Inventory   957,434    690,153 
Other current assets   1,718,069    2,233,897 
     Total current assets   189,836,621    70,680,120 
           
Fixed assets, net   264,706    198,592 
           
Other Assets:          
Intangible assets, net   1,694,546    1,615,251 
Prepaid expense   1,047,970    1,109,883 
Security deposit   125,000    125,000 
     Total other assets   2,867,516    2,850,134 
       Total assets  $192,968,843   $73,728,846 
           
 LIABILITIES AND STOCKHOLDERS' EQUITY          
Current Liabilities:          
Accounts payable  $3,430,649   $3,126,174 
Other current liabilities   6,165,764    7,539,526 
     Total current liabilities   9,596,413    10,665,700 
       Total liabilities   9,596,413    10,665,700 
           
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;          
196,253,700 and 177,928,041 issued and outstanding, respectively   196,254    177,928 
Additional paid-in capital   423,932,401    282,712,078 
Accumulated deficit   (240,756,225)   (219,826,860)
     Total stockholders' equity   183,372,430    63,063,146 
       Total liabilities and stockholders' equity  $192,968,843   $73,728,846 

 

 
 

 

THERAPEUTICSMD, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

   Three Months Ended
   March 31, 2016  March 31, 2015
       
Revenues, net  $4,930,091   $4,475,049 
           
Cost of goods sold   1,108,443    1,043,641 
           
Gross profit   3,821,648    3,431,408 
           
Operating expenses:          
Sales, general, and administrative   9,678,552    6,163,612 
Research and development   15,097,017    18,176,835 
Depreciation and amortization   19,597    13,572 
     Total operating expense   24,795,166    24,354,019 
           
Operating loss   (20,973,518)   (20,922,611)
           
Other income          
Interest income   41,617    18,513 
Accreted interest   2,536    9,842 
     Total other income   44,153    28,355 
           
Loss before income taxes   (20,929,365)   (20,894,256)
           
Provision for income taxes   —      —   
           
Net loss  $(20,929,365)  $(20,894,256)
           
Net loss per share, basic and diluted  $(0.11)  $(0.13)
           
Weighted average number of common          
  shares outstanding-basic and diluted   194,901,560    163,448,130 

 

 
 

 

THERAPEUTICSMD, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

   Three Months Ended
   March 31, 2016  March 31, 2015
       
CASH FLOWS FROM OPERATING ACTIVITIES      
  Net loss  $(20,929,365)  $(20,894,256)
     Adjustments to reconcile net loss to net cash used in          
        operating activities:          
          Depreciation of fixed assets   8,363    6,881 
          Amortization of intangible assets   11,234    6,691 
          Provision for doubtful accounts   236,151    13,004 
          Share-based compensation   4,381,690    840,464 
          Changes in operating assets and liabilities:          
             Accounts receivable   (2,250,209)   (502,836)
             Inventory   (267,281)   222,925 
             Other current assets   477,312    91,412 
             Other assets   (2,536)   (9,842)
             Accounts payable   304,475    (91,946)
             Deferred revenue   —      (522,613)
             Other current liabilities   (1,373,762)   1,038,813 
             Other long-term liabilities   —      651,567 
           
Net cash used in operating activities   (19,403,928)   (19,149,736)
           
CASH FLOWS FROM INVESTING ACTIVITIES          
  Patent costs   (90,529)   (36,853)
  Purchase of fixed assets   (74,478)   —   
           
Net cash used in investing activities   (165,007)   (36,853)
           
CASH FLOWS FROM FINANCING ACTIVITIES          
  Proceeds from sale of common stock, net of costs   134,863,475    59,117,827 
  Proceeds from exercise of options   786,450    7,208 
  Proceeds from exercise of warrants   1,310,000    358,400 
           
Net cash provided by financing activities   136,959,925    59,483,435 
           
Increase in cash   117,390,990    40,296,846 
Cash, beginning of period   64,706,355    51,361,607 
Cash, end of period  $182,097,345   $91,658,453