EX-99.1 2 ex99-1.htm PRESS RELEASE

 

TherapeuticsMD. Inc. 8-K

Exhibit 99.1

 

 

FOR IMMEDIATE RELEASE

 

 

TherapeuticsMD announces fourth quarter and full-year 2014 financial results

 

– Current women’s health product sales increased by 71 percent over prior year –

 

– Cash balance strengthened following recent equity financing of $59.1 million in net proceeds –

 

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

 

BOCA RATON, FL - March 10, 2015 – TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare company, today announced its fourth quarter and full-year financial results for the period ending Dec. 31, 2014.

 

2014 and recent corporate developments

 

·Net revenue increased to approximately $15.0 million in 2014 compared with approximately $8.8 million in the prior year, reflecting a 71 percent increase in product sales.
·Net loss was approximately $54.2 million in 2014 compared with approximately $28.4 million in the prior year, reflecting the company’s increased investment in clinical trials for two phase 3 pipeline products.
·The company initiated enrollment of patients in the phase 3 Rejoice Trial for TX-004HR, the VagiCap™ investigational softgel vaginal suppository for treatment of painful intercourse, a symptom of vulvar vaginal atrophy (VVA) due to menopause.
·The company continued enrollment of patients in the phase 3 Replenish Trial for TX-001HR, a novel investigational bio-identical estradiol-progesterone combination product candidate.
·The company’s intellectual property portfolio grew to include a current total of 93 patent filings, 55 of which were filed in international jurisdictions, and includes 11 U.S. patent allowances or issuances.
·The company completed the year with no outstanding debt and a cash balance of approximately $51.4 million, which was further strengthened by an equity offering in February 2015 that generated approximately $59.1 million in net proceeds.

 

“During 2014, we made significant advancements on both the commercial and R&D fronts, working toward our goal to build a leading women’s health company,” said TherapeuticsMD CEO Robert G. Finizio. “Our two lead pipeline programs continued to advance in phase 3 clinical trials, and sales from our current women’s health business grew at an impressive rate, which highlights the capabilities of our existing commercial infrastructure. We look forward to further advancing our pipeline this coming year, including completing enrollment in our phase 3 investigational combination therapy and VVA programs and delivering phase 3 results from the VVA program as planned.”

 

Summary of 2014 financial results

 

For the year ended Dec. 31, 2014, net revenue was approximately $15.0 million compared with approximately $8.8 million for the prior year. Revenue for the fourth quarter of 2014 was approximately $4.3 million compared with approximately $2.9 million in the prior year’s quarter, an increase of approximately 49 percent. Revenue growth during the fourth quarter and full-year of 2014 was primarily driven by increased sales of the company’s prenatal vitamin products, including the launch of new products and volume growth of existing products.

 

Cost of goods sold increased to approximately $3.7 million for the full-year 2014 compared with approximately $2.0 million for the prior year. 

 

 
 

Total operating expenses for the fourth quarter of 2014 and full-year ended Dec. 31, 2014, included research and development (R&D) expenses and sales, general and administrative expenses (SG&A). R&D expenses for the full-year 2014 were approximately $43.2 million compared with approximately $13.6 million for 2013, reflecting the company’s investment in two ongoing phase 3 clinical trials for its novel hormone therapy products in development. R&D expenses in the fourth quarter of 2014 were approximately $14.2 million compared with approximately $5.8 million in the prior year’s quarter, primarily due to the addition of a second phase 3 trial to support the company’s pipeline. SG&A expenses for the full-year 2014 were approximately $22.1 million compared with approximately $19.0 million for 2013. SG&A expenses in the fourth quarter of 2014 were approximately $5.5 million compared with approximately $4.6 million for the fourth quarter of 2013.

 

Non-operating income for the full-year 2014 included miscellaneous and interest income of approximately $84,000, offset by financing costs of approximately $260,000.

 

Net operating loss for the full-year 2014 was approximately $54.2 million or $0.36 per basic and diluted share, compared with approximately $28.4 million or $0.22 per basic and diluted share for 2013. Net operating loss in the fourth quarter of 2014 was approximately $16.3 million or $0.10 per basic and diluted share, compared with approximately $8.4 million or $0.06 per basic and diluted share for 2013.

 

At Dec. 31, 2014, TherapeuticsMD had cash on hand of approximately $51.4 million, compared with approximately $54.2 million at Dec. 31, 2013. In February 2015, the company completed a public offering of shares of its common stock for net proceeds of approximately $59.1 million.

 

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 and webcast include:

 

Date:

March 10, 2015

Time:

4:30 p.m. EDT

Telephone Access (US):

866-665-9531

Telephone Access (International):

724-987-6977

Access Code for All Callers:

91862074

 

Additionally, a live webcast can be accessed on the company’s website, www.therapeuticsmd.com, 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 patented SYMBODA™ technology platform, 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

 

Media:

Julia Amadio

Chief Product Officer

561-961-1900

Julia.Amadio@TherapeuticsMD.com

 

 
 

 

THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS

 

    December 31,
    2014     2013
ASSETS
Current Assets:          
Cash  $51,361,607   $54,191,260 
Accounts receivable, net of allowance for doubtful accounts          
  of $21,119 and $26,555, respectively   2,154,217    1,690,753 
Inventory   1,182,113    1,043,618 
Other current assets   1,537,407    2,477,715 
     Total current assets   56,235,344    59,403,346 
           
Fixed assets, net   63,293    61,318 
           
Other Assets:          
Prepaid expense   1,427,263    1,750,455 
Intangible assets   1,228,588    665,588 
Security deposit   125,000    135,686 
     Total other assets   2,780,851    2,551,729 
       Total assets  $59,079,488   $62,016,393 
           
 LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:          
Accounts payable  $6,327,129   $2,114,217 
Deferred revenue   522,613    1,602,580 
Other current liabilities   3,840,639    3,601,189 
     Total current liabilities   10,690,381    7,317,986 
           
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; 250,000,000 shares authorized;          
 156,097,019 and 144,976,757 issued and outstanding, respectively   156,097    144,977 
Additional paid in capital   182,982,846    135,086,056 
Accumulated deficit   (134,749,836)   (80,532,626)
     Total stockholders' equity   48,389,107    54,698,407 
       Total liabilities and stockholders' equity  $59,079,488   $62,016,393 

 

 

 
 

 

THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS

 

   Three Months Ended
December 31,		  Year Ended December 31,
   2014  2013  2014  2013  2012
                
Revenues, net  $4,257,647   $2,862,798   $15,026,219   $8,775,598   $3,818,013 
                          
Cost of goods sold   879,535    467,242    3,671,803    1,959,597    1,348,113 
         —                  
Gross profit   3,378,112    2,395,556    11,354,416    6,816,001    2,469,900 
                          
Operating expenses:                         
Sales, general, and administrative   5,514,057    4,558,998    22,124,072    19,014,837    14,069,701 
Research and development   14,166,789    5,840,717    43,218,938    13,551,263    4,492,362 
Depreciation and amortization   12,558    7,196    52,467    58,145    56,260 
     Total operating expense   19,693,404    10,406,911    65,395,477    32,624,245    18,618,323 
                          
Operating loss   (16,315,292)   (8,011,355)   (54,041,061)   (25,808,244)   (16,148,423)
                          
Other income and (expense)        —                  
Miscellaneous income   3,158    19,100    46,569    34,544    3,001 
Interest income   9,553    9,101    37,309    27,234    —   
Financing costs   —      (337,941)   (260,027)   (1,503,922)   —   
Interest expense   —      (58,044)   —      (1,165,981)   (1,905,409)
Loan guaranty costs   —      —      —      (2,944)   (45,036)
Loss on extinguishment of debt   —      —      —      —      (10,307,864)
Beneficial conversion feature   —      —      —      —      (6,716,504)
     Total other income (expense)   12,711    367,784    (176,149)   (2,611,069)   (18,971,812)
         —                  
Loss before taxes   (16,302,581)   (8,379,139)   (54,217,210)   (28,419,313)   (35,120,235)
                          
Provision for income taxes   —      —      —      —      —   
                          
Net loss  $(16,302,581)  $(8,379,139)  $(54,217,210)  $(28,419,313)  $(35,120,235)
                          
Net loss per share, basic and diluted  $(0.10)  $(0.06)  $(0.36)  $(0.22)  $(0.38)
                          
Weighted average number of common                         
  shares outstanding   156,054,938    144,983,681    149,727,228    127,569,731    91,630,693 

 

 
 

 

THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' (DEFICIT) EQUITY
FOR THE YEARS ENDED DECEMBER 31, 2014, 2013 AND 2012

 

    Common Stock    Additional
Paid in
Capital		    Accumulated
Deficit		    Total 
    Shares    Amount             
Balance, December 31, 2011   82,978,804    82,979    15,198,241    (16,993,078)   (1,711,858)
                          
Shares issued in private placement, net of cost   3,953,489    3,954    7,891,531    —      7,895,485 
Shares issued in exchange for debt   2,775,415    2,775    1,051,882    —      1,054,657 
Shares issued for exercise of options   1,931,788    1,932    189,068    —      191,000 
Shares issued for exercise of warrants   8,145,486    8,145    3,093,855    —      3,102,000 
Employee share based compensation   —      —      1,832,061    —      1,832,061 
Warrants issued for financing costs   —      —      13,014,784    —      13,014,784 
Warrants issued for services   —      —      1,563,620    —      1,563,620 
Warrants issued as compensation-related party   —      —      36,284    —      36,284 
Warrants issued for cash   —      —      400    —      400 
Cancellation of warrants issued for loan guaranty costs-related parties   —      —      (7,830)   —      (7,830)
Beneficial ownership feature   —      —      6,716,504    —      6,716,504 
Net loss   —      —      —      (35,120,235)   (35,120,235)
                          
Balance, December 31, 2012   99,784,982    99,785    50,580,400    (52,113,313)   (1,433,128)
                          
Shares issued in private placements, net of cost   45,116,352    45,117    78,605,236    —      78,650,353 
Shares issued for exercise of options   75,423    75    30,835    —      30,910 
Employee share based compensation   —      —      3,170,954    —      3,170,954 
Non-employee share based compensation   —      —      83,129    —      83,129 
Warrants issued for financing costs   —      —      1,711,956    —      1,711,956 
Warrants issued for services   —      —      867,262    —      867,262 
Warrants issued as compensation-related party   —      —      36,284    —      36,284 
Net loss   —      —      —      (28,419,313)   (28,419,313)
                          
Balance, December 31, 2013   144,976,757    144,977    135,086,056    (80,532,626)   54,698,407 
                          
Shares issued in private placements, net of cost   9,850,106    9,850    42,761,503    —      42,771,353 
Shares issued for exercise of options   854,573    855    344,891    —      345,746 
Shares issued for exercise of warrants   365,583    365    180,635    —      181,000 
Shares issued for exercise of restricted stock units   50,000    50    (50)   —      —   
Employee share based compensation   —      —      4,239,358    —      4,239,358 
Non-employee share based compensation   —      —      370,453    —      370,453 
Net loss   —      —      —      (54,217,210)   (54,217,210)
                          
Balance, December 31, 2014   156,097,019   $156,097   $182,982,846   $(134,749,836)  $48,389,107 

 

 

 
 

 

THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS

 

    Year Ended December 31, 
    2014    2013    2012 
CASH FLOWS FROM OPERATING ACTIVITIES               
  Net loss  $(54,217,210)  $(28,419,313)  $(35,120,235)
     Adjustments to reconcile net loss to net cash flows used in               
        operating activities:               
          Depreciation   28,987    47,883    27,484 
          Amortization of intangible assets   23,480    10,262    28,776 
          Provision for doubtful accounts   (5,436)   (15,493)   40,548 
          Loss on extinguishment of debt   —      —      10,307,864 
          Beneficial conversion feature   —      —      6,716,504 
          Amortization of debt discount   —      1,102,680    1,604,240 
          Stock based compensation   4,239,358    3,207,238    1,868,345 
          Amortization of deferred financing costs   260,027    1,451,934    —   
          Stock based expense for services   730,954    636,917    338,457 
          Loan guaranty costs   —      2,944    45,036 
          Changes in operating assets and liabilities:               
             Accounts receivable   (458,028)   (1,068,619)   (728,253)
             Inventory   (138,495)   571,592    (1,027,137)
             Other current assets   680,281    (1,386,319)   42,281 
             Other assets   (37,309)   (565,706)   —   
             Accounts payable   4,212,912    472,851    1,334,855 
             Deferred revenue   (1,079,967)   457,828    1,144,752 
             Accrued expenses and other current liabilities   239,450    2,875,320    639,157 
             Other liabilities   —      (150,068)   —   
                
                
Net cash flows used in operating activities   (45,520,996)   (20,768,069)   (12,737,326)
                
CASH FLOWS FROM INVESTING ACTIVITIES               
  Patent costs, net of abandoned costs   (586,480)   (439,034)   (206,101)
  Purchase of property and equipment   (30,962)   (40,790)   (66,405)
             Refund (payment) of security deposit   10,686    (103,737)   —   
                
                
Net cash flows used in investing activities   (606,756)   (583,561)   (272,506)
                
CASH FLOWS FROM FINANCING ACTIVITIES               
  Proceeds from sale of common stock, net of costs   42,771,353    78,650,353    7,895,485 
  Proceeds from exercise of options   345,746    30,910    191,000 
  Proceeds from exercise of warrants   181,000    —      —   
  Proceeds from notes and loans payable   —      —      8,700,000 
  Proceeds bank line of credit   —      500,000    —   
  Proceeds from sale of warrants   —      —      400 
  Repayment of bank line of credit   —      (500,000)   (300,000)
  Repayment of notes payable-related party   —      —      (200,000)
  Repayment of notes payable   —      (4,691,847)   (1,850,000)
                
                
Net cash flows provided by financing activities   43,298,099    73,989,416    14,436,885 
                
Increase in cash   (2,829,653)   52,637,786    1,427,053 
Cash, beginning of period   54,191,260    1,553,474    126,421 
Cash, end of period  $51,361,607   $54,191,260   $1,553,474 
                
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: 
                
Cash paid for interest  $—     $212,853   $17,253 
                
Cash paid for income taxes  $—     $—     $—   
                
SUPPLEMENTAL SCHEDULE OF NON-CASH FINANCING ACTIVITIES: 
                
Warrants issued for financing  $—     $1,711,956   $2,509,537 
                
Warrants issued for services  $—     $462,196   $1,532,228 
                
Warrants exercised in exchange for debt and accrued interest  $—     $—     $3,102,000 
                
Shares issued in exchange for debt and accrued interest  $—     $—     $1,054,658 
                
Notes payable issued for accrued interest  $—     $—     $15,123