UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): November 4, 2013

TherapeuticsMD, Inc.

(Exact Name of Registrant as Specified in its Charter)

Nevada   000-16731   87-0233535

(State or Other

Jurisdiction of Incorporation)

  (Commission File Number)   (IRS Employer
Identification No.)

 

6800 Broken Sound Parkway NW,

Third Floor

Boca Raton, FL 33487

(Address of Principal Executive Office) (Zip Code)

Registrant's telephone number, including area code: (561) 961-1900

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2 below):

£Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
£Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
£Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

£Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act

(17 CFR 240.13e-4(c))

 
 

Item 2.02. Results of Operations and Financial Condition.

On November 4, 2013, TherapeuticsMD, Inc. issued a press release announcing its results of operations for its third fiscal quarter ended September 30, 2013. A copy of the press release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.

The information in this Current Report on Form 8-K (including the exhibit) is furnished pursuant to Item 2.02 and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The information in this Current Report shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date of this Current Report, regardless of any general incorporation language in the filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

Exhibit

Number Description

99.1Press Release from TherapeuticsMD, Inc., dated November 4, 2013, entitled “TherapeuticsMD Reports Third Quarter 2013 Financial Results”.

 
 

 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: November 4, 2013   THERAPEUTICSMD, INC.
     
    By: /s/ Daniel A. Cartwright
    Name: Daniel A. Cartwright
    Title: Chief Financial Officer
 
 

EXHIBIT INDEX

 

Exhibit

Number

Description
   
 99.1Press Release from TherapeuticsMD, Inc., dated November 4, 2013, entitled “TherapeuticsMD Reports Third Quarter 2013 Financial Results”.

 

  

 

 TherapeuticsMD, Inc. 8-K

Exhibit 99.1

 

 

 

 

 

 

 

Contacts:
Dan Cartwright Investor Relations:
Chief Financial Officer Lisa M. Wilson
Tel: (561) 961-1930 In-Site Communications
Dan.Cartwright@TherapeuticsMD.com Tel: (917) 543-9932
  lwilson@insitecony.com

 

FOR IMMEDIATE RELEASE

 

therapeuticsmd reports THIRD quarter 2013 financial results

 

Management to Host Conference Call at 4:30 EST today

 

Boca Raton, FL, November 4, 2013 – TherapeuticsMD, Inc. (NYSE MKT: TXMD), a women’s healthcare company, today announced financial results for the three- and nine-month periods ended September 30, 2013.

 

Third Quarter 2013 Highlights:

·Net revenue increased to $2.3 million compared with $1.0 million for the third quarter of 2012;
·Net loss increased to $7.7 million as compared with a net loss of $4.3 million for the third quarter of 2012;
·Released results of a 48-patient, 14-day phase 1 clinical study, which indicated that treatment with TX 12-004-HR estradiol VagiCap™ at the 10μg dose improved objective measures of Vulvar and Vaginal Atrophy;
·Received the first-place prize at the North American Menopause Society (NAMS) 2013 Annual Meeting for our poster detailing findings on the first investigational combination 17β-estradiol and progesterone capsule (TX 12-001-HR E+P) that may have overcome the well-recognized difficulties of achieving good bioavailability with oral administration of these hormones in combination;
·Initiated the REPLENISH Trial, a phase 3 clinical trial designed to measure the safety and effectiveness of TX 12-001-HR E+P, in treating the symptoms of menopause;
·Raised approximately $33 million in gross proceeds through an underwritten offering of 13,750,000 shares of common stock; and,
·Appointed Sebastian Mirkin, M.D., a prominent women’s health product development executive with extensive experience in the pharmaceutical industry and clinical research, as Chief Medical Officer, effective November 25, 2013.

 

Robert G. Finizio, Co-Founder and Chief Executive Officer, stated, “We are pleased with the progress of our clinical initiatives for our three hormone-candidate products and look forward to making continued headway to support our goal of bringing innovative women’s healthcare products to market. The recognition that we received by NAMS for our innovative poster, underscoring the potential benefits of our combination product, the significant hire of Dr. Sebastian Mirkin and a solid balance sheet creates strong, positive momentum for TXMD.

 

Third Quarter Results

Net revenue for the third quarter of 2013 totaled $2.3 million compared with net revenue of $1.0 million for the year ago quarter. The increase of approximately $1.3 million, or 121%, was directly attributable to an increase in the number of physicians writing prescriptions for our prenatal products, the increased productivity of our sales force, an increase in the average net sales price of our product, and new prescription products introduced in March, April, May and November 2012. Cost of goods sold increased by $342 thousand, or 111%, for the three months ended September 30, 2013 compared with the prior year quarter. Research and development expenses increased to $4.1 million for the third quarter of 2013 compared with $1.7 million for the third quarter of 2012, due to costs incurred in the development of our new hormone replacement therapy and prescription prenatal products. Sales, general and administrative expenses increased to $4.8 million for the third quarter of 2013 compared with $2.9 million for the third quarter of 2012. As a result, our operating loss was $7.2 million for the third quarter of 2013 compared with $3.9 million for the third quarter of 2012.

 
 

 

Other non-operating expenses increased by approximately $93,000 for the third quarter of 2013 compared with the comparable quarter in 2012. This increase was primarily a result of non-cash financing costs incurred during the current period totaling approximately $448,000, partially offset by a decrease in interest expense of approximately $134,000 and loss on extinguishment of debt of approximately $197,000.

 

As a result, net loss for the third quarter of 2013 was $7.7 million, or $0.06 per basic and diluted share, compared with a net loss of $4.3 million, or $0.04 per basic and diluted share, for the third quarter of 2012.

 

Nine Months Results

Net revenue for the nine months ended September 30, 2013 totaled $5.9 million compared with net revenue of approximately $2.6 million for the year ago period. The increase of approximately $3.3 million, or 129%, was directly attributable to an increase in the number of physicians writing prescriptions for our prenatal products, the increased productivity of our sales force, an increase in the average net sales price of our product, and new prescription products introduced in March, April, May and November 2012. Cost of goods sold increased by $477 thousand, or 47%, for the nine months ended September 30, 2013 compared with the prior year period. Research and development expenses increased to $7.7 million for the nine months ended September 30, 2013 compared with $3.1 million for the comparable period in 2012, because of costs incurred in the development of our new hormone replacement therapy and prescription prenatal products. Sales, general and administrative expenses increased to $14.5 million for the nine months ended September 30, 2013 compared with $9.1 million for the prior year period. As a result, our operating loss was $17.8 million for the nine months ended September 30, 2013 compared with $10.8 million for the comparable period in 2012.

 

Other non-operating expenses decreased by $16.4 million for the nine months ended September 30, 2013 compared with the comparable period in 2012. This decrease resulted primarily from a loss on extinguishment of debt, the beneficial conversion of debt and interest expense incurred during 2012, partially offset by an increase in amortization of financing costs of $1.1 million.

 

As a result, net loss for the nine months ended September 30, 2013 was $20.0 million, or $0.16 per basic and diluted share, compared with a net loss of $29.4 million, or $0.33 per basic and diluted share, for the comparable period in 2012.

 

Cash and cash equivalents increased to $59.6 million at September 30, 2013.

 

Conference Call

As previously announced, Robert G. Finizio, Co-Founder and Chief Executive Officer, and Dan Cartwright, Chief Financial Officer, will host a conference call today to review the results as follows:

 

Date November 4, 2013
Time 4:30 p.m. (Eastern Standard Time)
Telephone access 800-619-2686 (U.S. and Canada)
  303-223-4363 (International)
Access code 21682427
Live webcast www.therapeuticsmd.com, under the Investor tab

 

An audio replay will be available on-demand shortly after the completion of the call until November 18, 2013 at 11:59 pm EST at the aforementioned URL, or by dialing 800-633-8284 in the U.S. and Canada, or 402-977-9140 from abroad. The access code for all callers is 21682427.

 
 

 

About Hormone Therapy

Hormone therapy (HT) is the administration of hormones to supplement a lack of naturally occurring hormones. HT options include natural, bioidentical, and non-bioidentical (conjugated) hormones. HT is projected to be the largest growth segment in the overall women’s health market. The potential market for pharmacy-compounded, bioidentical HT products is estimated to be approximately $1.5 billion per year.


About TherapeuticsMD, Inc.

TherapeuticsMD, Inc. is a women’s healthcare company focused on developing and commercializing products targeted exclusively for women. We manufacture and distribute branded and generic prescription prenatal vitamins, as well as over-the-counter vitamins and cosmetics, under our vitaMedMD® and BocaGreenMD™ brands. We are currently developing advanced hormone therapy pharmaceutical products designed to alleviate the symptoms of and reduce the health risks resulting from menopause-related hormone deficiencies. We are also evaluating various other potential indications for our hormone technology, including oral contraception, preterm birth, vulvar and vaginal atrophy, and premature ovarian failure. More information is available at the following websites: www.therapeuticsmd.com, www.vitamedmd.com, www.vitamedmdrx.com, and www.bocagreenmd.com.

 

vitaMedMD® and TherapeuticsMD® are registered trademarks of TherapeuticsMD, Inc. and BocaGreenMD™ is a trademark of TherapeuticsMD, Inc.

 

Except for the historical information contained herein, the matters set forth in this press release, including statements relating to future events or performance, including statements regarding the company’s performance; the results of the phase 1 clinical study of TX 12-004-HR; the possibility that TX 12-001-HR may have overcome the well-recognized difficulties of achieving good bioavailability with oral administration in combination; the REPLENISH trial; the company’s plans for the clinical initiatives of its three hormone-candidate products; the company’s goal of bringing innovative women’s healthcare products to market; the impact of the recognition the company received at the NAMS annual meeting; the impact of the appointment of Dr. Mirkin; the impact of the increase in sales territories, sales people, and new prescription products; the impact of development of the company’s new hormone replacement therapy and prescription prenatal products; projected growth and the size of the potential market for pharmacy-compounded, bioidentical HT products; the company’s current product pipeline and hormone technology that the company is evaluating are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including but not limited to: timely and successful completion of clinical studies and the results thereof; challenges and costs inherent in product marketing; the risks and uncertainties associated with economic and market conditions; risks and uncertainties associated with the Company’s business and finances in general; and other risks detailed in the Company’s filings with the U.S. Securities and Exchange Commission including its annual report on Form 10-K filed on March 12, 2013, reports on Form 10-Q and Form 8-K, and other such filings. These forward-looking statements are based on current information that may change. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and the Company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.

 
 

 

THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
         
   September 30, 2013   December 31, 2012 
   (Unaudited)     
ASSETS          
Current Assets:          
Cash  $59,572,347   $1,553,474 
Accounts receivable, net of allowances of $90,403 and $42,048, respectively   1,793,719    606,641 
Inventory   1,147,586    1,615,210 
Other current assets   3,419,704    751,938 
Total current assets   65,933,356    4,527,263 
           
Fixed assets, net   47,392    65,673 
           
Other Assets:          
Prepaid expense   1,870,003    953,655 
Intangible assets   488,274    239,555 
Security deposit   138,307    31,949 
Total other assets   2,496,584    1,225,159 
Total assets  $68,477,332   $5,818,095 
           
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)          
Current Liabilities:          
Accounts payable  $2,471,951   $1,641,366 
Deferred revenue   1,852,272    1,144,752 
Other current liabilities   2,066,116    725,870 
Total current liabilities   6,390,339    3,511,988 
           
Long-Term Liabilities:          
Notes payable, net of debt discount of $0 and $1,102,680, respectively       3,589,167 
Accrued interest       150,068 
Total long-term liabilities       3,739,235 
Total liabilities   6,390,339    7,251,223 
           
Commitments and Contingencies          
           
Stockholders' Equity (Deficit):          
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;144,962,706 and 99,784,982 issued and outstanding, respectively   144,963    99,785 
Additional paid-in capital   134,095,517    50,580,400 
Accumulated deficit   (72,153,487)   (52,113,313)
Total stockholder' equity (deficit)   62,086,993    (1,433,128)
Total liabilities and stockholders' equity (deficit)  $68,477,332   $5,818,095 

 

See accompanying Notes to Condensed Consolidated Financial Statements.

 
 

THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
 
   Three Months Ended   Nine Months Ended 
   September 30,   September 30, 
   2013   2012   2013   2012 
   (Unaudited)   (Unaudited)   (Unaudited)   (Unaudited) 
                 
Revenues, net  $2,294,720   $1,036,456   $5,912,800   $2,577,298 
                     
Cost of goods sold   648,403    306,843    1,492,355    1,015,337 
                     
Gross profit   1,646,317    729,613    4,420,445    1,561,961 
                     
Operating expenses:                    
Sales, general, and administration   4,752,062    2,923,242    14,455,839    9,139,894 
Research and development   4,098,903    1,702,120    7,710,546    3,131,306 
Depreciation and amortization   32,356    14,839    50,949    43,952 
Total operating expense   8,883,321    4,640,201    22,217,334    12,315,152 
                     
Operating loss   (7,237,004)   (3,910,588)   (17,796,889)   (10,753,191)
                     
Other income (expense):                    
Miscellaneous income   11,965    932    15,444    2,486 
Interest income           18,133     
Interest expense       (134,475)   (1,165,981)   (1,385,209)
Financing costs   (447,969)       (1,107,937)    
Loan guaranty costs       (11,745)   (2,944)   (35,235)
Beneficial conversion feature               (6,716,504)
Loss on extinguishment of debt       (197,383)       (10,505,247)
Total other income (expense)   (436,004)   (342,671)   (2,243,285)   (18,639,709)
                     
Loss before taxes   (7,673,008)   (4,253,259)   (20,040,174)   (29,392,900)
                     
Provision for income taxes                
                     
Net loss  $(7,673,008)  $(4,253,259)  $(20,040,174)  $(29,392,900)
                     
Loss  per share, basic and diluted:                    
                     
Net loss per share, basic and diluted  $(0.06)  $(0.04)  $(0.16)  $(0.33)
                     
Weighted average number of common shares outstanding   131,212,706    95,895,677    121,701,292    88,892,757 

 

 

See accompanying Notes to Condensed Consolidated Financial Statements.

 
 

THERAPEUTICSMD, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

   Nine Months Ended 
   September 30, 
   2013   2012 
   (Unaudited)   (Unaudited) 
         
CASH FLOWS FROM OPERATING ACTIVITIES          
Net loss  $(20,040,174)  $(29,392,900)
Adjustments to reconcile net loss to net cash flows used in operating activities:          
Depreciation   41,186    21,241 
Amortization of intangible assets   9,764    22,711 
Provision for doubtful accounts   48,355    33,213 
Amortization of debt discount   1,102,680    1,159,375 
Stock based compensation   1,926,992    1,031,685 
Amortization of deferred financing costs   1,055,948     
Stock based expense for services   804,878    233,093 
Loan guaranty costs   2,944    35,235 
Loss on debt extinguishment       10,505,247 
Beneficial conversion feature       6,716,504 
Changes in operating assets and liabilities:          
Accounts receivable   (1,235,433)   (276,755)
Inventory   467,624    (367,056)
Other current assets   (1,927,156)   (28,925)
Other assets   (878,616)    
Accounts payable   830,585    724,542 
Accrued interest   (150,068)   216,281 
Other current liabilities   1,340,246    (66,087)
Deferred revenue   707,520    701,929 
           
Net cash flows used in operating activities   (15,892,725)   (8,730,667)
           
CASH FLOWS FROM INVESTING ACTIVITIES          
Patent costs   (257,633)   (88,223)
Payment of security deposit   (106,358)    
Purchase of property and equipment   (23,755)   (68,904)
           
Net cash flows used in investing activities   (387,746)   (157,127)
           
CASH FLOWS FROM FINANCING ACTIVITIES          
Proceeds from sale of common stock, net   78,984,960    125,001 
Proceeds from line of credit   500,000     
Proceeds from exercise of options   6,231    190,999 
Proceeds from notes and loans payable       8,700,000 
Repayment of notes payable   (4,691,847)   (50,780)
Repayment of line of credit   (500,000)    
Repayment of notes payable-related party       (50,000)
Proceeds from sale of warrants       400 
           
Net cash flows provided by financing activities   74,299,344    8,915,620 
           
Increase in cash   58,018,873    27,826 
Cash, beginning of period   1,553,474    126,421 
Cash, end of period   59,572,347   $154,247 
           
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:          
           
Cash paid for interest  $212,853   $37,087 
           
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 issued 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 

 

 

See accompanying Notes to Condensed Consolidated Financial Statements.