THERAPEUTICSMD, INC. 8-K

 

Exhibit 99.1

 

 

 

FOR IMMEDIATE RELEASE

 

 

TherapeuticsMD Announces Fourth Quarter and Full Year 2017 Financial Results

 

- PDUFA target action date of May 29, 2018 for TX-004HR -

 

- Acceptance of New Drug Application for TX-001HR expected in March 2018 -

 

BOCA RATON, Fla. February 20, 2018 – TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women’s healthcare company, today announced its fourth quarter and full-year financial results for 2017.

 

2017 and Recent Developments

 

Resubmitted 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, on November 29, 2017. The Food and Drug Administration (FDA) has acknowledged that the resubmission is a complete, class 2 response to the Complete Response Letter (CRL) received on May 5, 2017 for TX-004HR. The PDUFA target action date for the completion of the FDA's review of the NDA is May 29, 2018.

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 submitted the NDA for TX-001HR on December 28, 2017.

Net revenue for the company’s prescription prenatal vitamin business was approximately $16.8 million for 2017 compared with approximately $19.4 million for 2016.

Net loss was approximately $76.9 million for 2017, compared with approximately $89.9 million for 2016.

Ended the year with approximately $127.1 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 211 patent filings, including 123 international filings, with one allowed and 18 issued U.S. patents.

 

“Our company has tremendous opportunity in 2018,” said TherapeuticsMD CEO Robert G. Finizio. “We have the potential for approvals of both of our late-stage product candidates in 2018, representing a major inflection point for our company.”

 

Summary of 2017 Financial Results

 

For the year ended December 31, 2017, net revenue was approximately $16.8 million compared with approximately $19.4 million for the prior year. Net revenue for the fourth quarter of 2017 was approximately $4.1 million compared with net revenue of approximately $4.5 million for the prior year’s quarter. These changes were primarily due to a decrease in the average net revenue per unit of the company’s products, primarily related to higher coupons in 2017, partially offset by a slight increase in the number of units sold.

   
 

Total operating expenses for the fourth quarter and full-year 2017 included research and development (R&D) expenses and sales, general and administrative expenses (SG&A). R&D expenses for the full-year 2017 were approximately $33.9 million compared with approximately $53.9 million for the prior year. R&D expenses for the fourth quarter of 2017 were approximately $11.0 million compared to approximately $10.3 million during the prior year’s quarter. The decreases in R&D for full-year 2017 were primarily due to lower clinical trial costs as the company completed its phase 3 clinical trials for TX-001HR and TX-004HR. SG&A expenses for the full-year 2017 were approximately $57.7 million compared with approximately $51.3 million for the prior year. SG&A expenses for the fourth quarter of 2017 were approximately $14.2 million compared with approximately $16.3 million for the prior year’s quarter. The increases in SG&A for full-year 2017 were primarily due to higher sales, marketing, regulatory expenditures, and personnel costs to support future commercialization.

Net loss for the full-year 2017 was approximately $76.9 million, or $0.37 per basic and diluted share, compared with approximately $89.9 million, or $0.46 per basic and diluted share, for the full-year 2016. Net loss in the fourth quarter of 2017 was approximately $21.4 million, or $0.10 per basic and diluted share, compared with approximately $22.8 million, or $0.12 per basic and diluted share, for the fourth quarter of 2016.

At December 31, 2017, cash on hand was approximately $127.1 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.

 

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, February 20, 2018

Time:

4:30 p.m. EST

Telephone Access (US):

866-665-9531

Telephone Access (International):

724-987-6977

Access Code for All Callers:

3789163

 

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: 3789163.

 

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 FDA will approve the amended NDA for the company’s TX-004HR product candidate and whether such approval will occur by the PDUFA target action 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 FDA will accept and approve the NDA for the company’s TX-001HR product candidate; 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

 

    December 31,  
    2017     2016  
ASSETS  
Current Assets:                
Cash   $ 127,135,628     $ 131,534,101  
Accounts receivable, net of allowance for doubtful accounts of $380,580 and $376,374, respectively     4,328,802       4,500,699  
Inventory     1,485,358       1,076,321  
Other current assets     6,604,284       2,299,052  
Total current assets     139,554,072       139,410,173  
                 
Fixed assets, net     437,055       516,839  
                 
Other Assets:                
Intangible assets, net     3,099,747       2,405,972  
Security deposit     139,036       139,036  
Total other assets     3,238,783       2,545,008  
Total assets   $ 143,229,910     $ 142,472,020  
                 
LIABILITIES AND STOCKHOLDERS’ EQUITY  
Current Liabilities:                
Accounts payable   $ 4,097,600     $ 7,358,514  
Other current liabilities     9,223,595       7,624,085  
Total current liabilities     13,321,195       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     516,351,405       436,995,052  
Accumulated deficit     (386,659,120 )     (309,702,319 )
Total stockholders’ equity     129,908,715       127,489,421  
Total liabilities and stockholders’ equity   $ 143,229,910     $ 142,472,020  

 

 

   
 

 

THERAPEUTICSMD, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

 

   Three Months Ended December 31,  Year Ended December 31,  
   2017  2016  2017  2016  2015  
                
Revenues, net  $4,124,218   $4,487,427   $16,777,713   $19,356,450   $20,142,898 
                          
Cost of goods sold   594,769    709,711    2,636,943    4,185,708    4,506,673 
                          
Gross profit   3,529,449    3,777,716    14,140,770    15,170,742    15,636,225 
                          
Operating expenses:                         
Sales, general, and administrative   14,178,958    16,329,146    57,703,370    51,348,414    28,721,236 
Research and development   10,974,956    10,341,144    33,852,993    53,943,477    72,042,774 
Depreciation and amortization   56,174    48,132    213,117    132,451    62,400 
                          
     Total operating expenses   25,210,088    26,718,422    91,769,480    105,424,342    100,826,410 
                          
Operating loss   (21,680,639)   (22,940,706)   (77,628,710)   (90,253,600)   (85,190,185)
                          
Other income                         
Miscellaneous income   253,309    101,438    695,631    367,317    95,719 
Accreted interest   —      2,974    7,699    10,824    17,442 
                          
     Total other income   253,309    104,412    703,330    378,141    113,161 
                          
Loss before income taxes   (21,427,330)   (22,836,294)   (76,925,380)   (89,875,459)   (85,077,024)
                          
Provision for income taxes   —      —      —      —      —   
                          
Net loss  $(21,427,330)  $(22,836,294)  $(76,925,380)  $(89,875,459)  $(85,077,024)
                          
Loss per share, basic and diluted:                         
                          
Net loss per share, basic and diluted  $(0.10)  $(0.12)  $(0.37)  $(0.46)  $(0.49)
                          
Weighted average number of common                         
  shares outstanding, basic and diluted   216,429,642    196,613,297    205,523,288    196,088,196    173,174,229 

 

 

 

   
 

 

THERAPEUTICSMD, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

 

    Year Ended December, 31,  
    2017     2016     2015  
CASH FLOWS FROM OPERATING ACTIVITIES                        
Net loss   $ (76,925,380 )   $ (89,875,459 )   $ (85,077,024 )
Adjustments to reconcile net loss to net cash used in operating activities:                        
Depreciation     141,601       77,906       29,959  
Amortization of intangible assets     71,516       54,545       32,441  
Provision for doubtful accounts     4,206       2,524,909       22,157  
Share-based compensation     6,889,323       17,411,021       7,189,699  
Changes in operating assets and liabilities:                        
Accounts receivable     167,691       (3,975,893 )     (917,656 )
Inventory     (409,037 )     (386,168 )     491,960  
Other current assets     (4,434,130 )     709,907       (773,532 )
Other assets                 (17,442 )
Accounts payable     (3,260,914 )     4,232,340       (3,200,955 )
Deferred revenue                 (522,613 )
Other current liabilities     1,599,510       84,559       3,698,887  
                         
Net cash used in operating activities     (76,155,614 )     (69,142,333 )     (79,044,119 )
                         
CASH FLOWS FROM INVESTING ACTIVITIES                        
Patent costs     (765,291 )     (845,266 )     (419,104 )
Purchase of fixed assets     (61,817 )     (396,154 )     (165,257 )
Payment of security deposit           (14,036 )      
                         
Net cash used in investing activities     (827,108 )     (1,255,456 )     (584,361 )
                         
CASH FLOWS FROM FINANCING ACTIVITIES                        
Proceeds from sale of common stock, net of costs     68,572,635       134,863,475       91,374,649  
Proceeds from exercise of options     212,615       989,060       1,232,579  
Proceeds from exercise of warrants     3,798,999       1,373,000       366,000  
                         
Net cash provided by financing activities     72,584,249       137,225,535       92,973,228  
                         
(Decrease) increase in cash     (4,398,473 )     66,827,746       13,344,748  
Cash, beginning of period     131,534,101       64,706,355       51,361,607  
Cash, end of period   $ 127,135,628     $ 131,534,101     $ 64,706,355  

 

   

 


The following information was filed by Therapeuticsmd, Inc. (TXMD) on Tuesday, February 20, 2018 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-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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