UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

(Mark One)

SþQUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

   For the quarterly period ended March 31, 2014

  
For the quarterly period ended September 30, 2013
£¨TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ___________ to ___________

 

   For the transition period from________ to ___________

Commission File No.000-16731

 

THERAPEUTICSMD, INC.


(Exact Name of Registrant as Specified in Its Charter)

Nevada 
Nevada87-0233535
(State or Other Jurisdiction of Incorporation or Organization)(I.R.S. Employer Identification No.)

  
6800 Broken Sound Parkway NW, Third Floor, Boca Raton, FL 33487(561) 961-1900
(Address of Principal Executive Offices)(Issuer’s Telephone Number)
N/A
(Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report)

 

N/A

(Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report)

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YesSþNo£¨

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). YesSþNo£¨

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of "large“large accelerated filer," "accelerated filer"” “accelerated filer” and "smaller“smaller reporting company"company” in Rule 12b-2 of the Exchange Act (Check one):

 

Large accelerated filer£¨ Accelerated filerSþ
Non-accelerated filer£¨ Smaller reporting company£¨
(Do not check if a smaller reporting company)

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes£¨NoSþ

 

The number of shares outstanding of the registrant’s common stock, par value $0.001 per share, as of November 4, 2013May 2, 2014 was 144,968,007. 145,439,582.



 
 

THERAPEUTICSMD, INC. AND SUBSIDIARIES
INDEX
     
    Page
PART I - FINANCIAL INFORMATION  
     
ItemItem. 1.Financial Statements  
     
  Condensed Consolidated Balance Sheets as of September 30, 2013March 31, 2014 (Unaudited) and December 31, 20122013 3
     
  Condensed Consolidated Statements of Operations for the Three and Nine  Months Ended September 30,March 31, 2014 (Unaudited) and 2013 (Unaudited) and 2012 (Unaudited) 4
     
  Condensed Consolidated Statements of Cash Flows for the NineThree Months Ended September 30,March 31, 2014 (Unaudited) and 2013 (Unaudited) and 2012 (Unaudited) 5
     
  Notes to Condensed Consolidated Financial Statements 6
     
 Item 2.Management's Discussion and Analysis of Financial Condition and Results of Operations 2220
     
 Item 3.Quantitative and Qualitative Disclosures about Market RiskRisks 3126
     
 Item 4.Controls and Procedures 3126
     
PARTPart II - OTHER INFORMATION  
Item 1.Legal Proceedings32
     
 Item 1A.Risk Factors 32
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds32
Item 3.Defaults upon Senior Securities32
Item 4.Mine Safety Disclosures3227
     
 Item 5.Other Information 3227
     
 Item 6.Exhibits 3227
2
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)

  March 31, 2014 December 31, 2013
  (Unaudited)  
ASSETS        
Current Assets:        
Cash $45,404,402  $54,191,260 
Accounts receivable, net of allowance for doubtful accounts of $32,601 and $26,555, respectively  2,339,455   1,690,753 
Inventory  920,685   1,043,618 
Other current assets  2,303,522   2,477,715 
     Total current assets  50,968,064   59,403,346 
         
Fixed assets, net  77,888   61,318 
         
Other Assets:        
Prepaid expense  1,630,960   1,750,455 
Intangible assets  756,926   665,588 
Security deposit  135,686   135,686 
     Total other assets  2,523,572   2,551,729 
       Total assets $53,569,524  $62,016,393 
         
 LIABILITIES AND STOCKHOLDERS' EQUITY        
Current Liabilities:        
Accounts payable $3,068,730  $2,114,217 
Deferred revenue  1,478,309   1,602,580 
Other current liabilities  2,271,973   3,601,189 
     Total current liabilities  6,819,012   7,317,986 
         
       Total liabilities  6,819,012   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; 145,067,060 and 144,976,757 issued and outstanding, respectively  145,067   144,977 
Additional paid in capital  136,321,189   135,086,056 
Accumulated deficit  (89,715,744)  (80,532,626)
     Total stockholders' equity  46,750,512   54,698,407 
       Total liabilities and stockholders' equity $53,569,524  $62,016,393 

The accompanying footnotes are an integral part of these condensed consolidated financial statements.

3
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)

  Three Months Ended 
  March 31, 2014  March 31, 2013 
     
     
Revenues, net $2,830,533  $1,537,195 
         
Cost of goods sold  830,707   380,346 
         
Gross profit  1,999,826   1,156,849 
         
Operating expenses:        
Sales, general, and administrative  5,029,497   4,526,582 
Research and development  5,908,078   1,565,201 
Depreciation and amortization  13,068   7,957 
         
     Total operating expense  10,950,643   6,099,740 
         
Operating loss  (8,950,817)  (4,942,891)
         
Other income and (expense)        
Miscellaneous income  18,572   —   
Interest income  9,154   —   
Financing costs  (260,027)  (263,987)
Interest expense  —     (1,165,831)
Loan guaranty costs  —     (2,944)
         
     Total other expense  (232,301)  (1,432,762)
         
Loss before taxes  (9,183,118)  (6,375,653)
         
Provision for income taxes  —     —   
         
Net loss $(9,183,118) $(6,375,653)
         
Net loss per share, basic and diluted $(0.06) $(0.06)
         
Weighted average number of commonshares outstanding  145,019,561   103,052,956 

The accompanying footnotes are an integral part of these condensed consolidated financial statements.

4
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
     

  Three Months Ended 
  March 31, 2014  March 31, 2013 
     
CASH FLOWS FROM OPERATING ACTIVITIES        
Net loss $(9,183,118) $(6,375,653)
Adjustments to reconcile net loss to net cash flows used in operating activities:        
          Depreciation  7,122   4,703 
          Amortization of intangible assets  5,946   3,254 
          Provision for doubtful accounts  6,046   21,795 
          Amortization of debt discount  —     1,102,680 
          Stock based compensation  1,009,526   542,377 
          Amortization of deferred financing costs  260,027   263,987 
          Stock based expense for services  314,291   178,959 
          Loan guaranty costs  —     2,944 
          Changes in operating assets and liabilities:        
             Accounts receivable  (654,748)  (17,978)
             Inventory  122,933   277,340 
             Other current assets  (85,834)  (731)
             Other assets  (9,154)  —   
             Accounts payable  954,513   199,445 
             Deferred revenue  (124,271)  (2,379)
             Accrued expenses and other current liabilities  (1,329,216)  290,575 
         
Net cash flows used in operating activities  (8,705,937)  (3,508,682)
         
CASH FLOWS FROM INVESTING ACTIVITIES        
  Patent costs, net of abandoned costs  (97,284)  (80,949)
  Purchase of property and equipment  (23,692)  (22,905)
         
Net cash flows used in investing activities  (120,976)  (103,854)
         
CASH FLOWS FROM FINANCING ACTIVITIES        
  Proceeds from exercise of options  40,055   —   
  Proceeds from sale of common stock, net of costs  —     45,430,472 
  Proceeds from revolving credit note  —     400,000 
  Proceeds from notes and loans payable  —     100,000 
  Repayment of revolving credit note  —     (400,000)
  Repayment of notes payable  —     (4,691,847)
         
Net cash flows provided by financing activities  40,055   40,838,625 
         
(Decrease) increase in cash  (8,786,858)  37,226,089 
Cash, beginning of period  54,191,260   1,553,474 
Cash, end of period $45,404,402  $38,779,563 
         
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:        
         
Cash paid for interest $—    $191,258 
         
Cash paid for income taxes $—    $—   
         
SUPPLEMENTAL SCHEDULE OF NON-CASH FINANCING ACTIVITIES:        
         
Warrants issued for financing $—    $1,711,956 

 

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 

SeeThe 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. 

footnotes are an integral part of these condensed consolidated financial statements.

5
 

THERAPEUTICSMD, INC. AND SUBSIDIARIES


NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

NOTE 1 – THE COMPANY

 

TherapeuticsMD, Inc., a Nevada corporation, or TherapeuticsMD or the Company, has two wholly owned subsidiaries, vitaMedMD, LLC, a Delaware limited liability company organized on May 13, 2008, or VitaMed, and BocaGreenMD, Inc., a Nevada corporation incorporated on January 10, 2012, or BocaGreen. Unless the context otherwise requires, TherapeuticsMD, VitaMed, and BocaGreen collectively are sometimes referred to as "our“our company," "we," "our,"” “we,” “our,” or "us."“us.”

 

Nature of Business

 

We are a women’s healthcarehealth care product company focused on creating and commercializing products targeted exclusively for women. Currently, we are focused on conducting the clinical trials necessary for regulatory approval and commercialization of advanced hormone therapy pharmaceutical products. The current drug candidates used in our clinical trials are designed to alleviate the symptoms of and reduce the health risks resulting from menopause-related hormone deficiencies, including hot flashes, osteoporosis, and vaginal dryness. We currentlyare developing these hormone therapy drug candidates, which contain estradiol and progesterone alone or in combination, with the aim of demonstrating equivalent clinical efficacy at lower doses, thereby enabling an enhanced side effect profile compared with competing products. Our drug candidates are created from a platform of hormone technology that enables the administration of hormones with high bioavailability alone or in combination. In addition, we manufacture and distribute branded and generic prescription prenatal vitamins, as well as over-the-counter, or OTC, vitamins and cosmetics.

 

NOTE 2 – BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS

 

Interim Financial Statements

 

OurThe accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q. Accordingly, they do notof TherapeuticsMD, Inc., which include all of the information and footnotes required by generally accepted accounting principles, or GAAP, for complete financial statements. In our opinion, such financial statements include all adjustments (consisting solely of normal recurring adjustments) necessary for the fair statement of the financial information included herein in accordance with GAAP and the rules and regulations of the Securities and Exchange Commission, or the SEC. The balance sheet at December 31, 2012 has been derived from the audited financial statements at that date but does not include all of the information and footnotes required by GAAP for complete financial statements. The preparation of financial statements in conformity with GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the period. Actual results could differ from those estimates. Results of operations for interim periods are not necessarily indicative of results for the full year. These unaudited interim condensed consolidated financial statementswholly owned subsidiaries, should be read in conjunction with the audited consolidated financial statements and related notes thereto included in our Annual Report on Form 10-K filed with the SEC for the year ended December 31, 2012.2013, as filed with the Securities and Exchange Commission, or the SEC, from which we derived our balance sheet as of December 31, 2013. The accompanying financial statements have been prepared in accordance with U.S. generally accepted accounting principles, or GAAP, for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, since they are interim statements, the accompanying financial statements do not include all of the information and notes required by GAAP for complete financial statements. The accompanying financial statements reflect all adjustments, consisting of normal recurring adjustments, that are, in the opinion of our management, necessary to a fair statement of the results for the interim periods presented. Interim results are not necessarily indicative of results for a full year.

 

Fair Value of Financial Instruments

6

 

Our financial instruments consist primarily of accounts receivable, accounts payable, accrued expenses, and short-term debt. The carrying amount of accounts receivable, accounts payable, and accrued expenses approximates their fair value because of the short-term maturity of such instruments and are considered Level 1 assets under the fair value hierarchy. Interest rates that are currently available to us for issuance of short and long-term debt with similar terms and remaining maturities are used to estimate the fair value of our short and long-term debt and would be considered Level 3 inputs under the fair value hierarchy.

THERAPEUTICSMD, INC. AND SUBSIDIARIES


NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

NOTE 2 – BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING

PRONOUNCEMENTS (Continued)

 

Fair Value of Financial Measurements

We categorize our assets and liabilities that are valued at fair value on a recurring basis into a three-level fair value hierarchy as defined by Accounting Standards Codification, or ASC, 820Fair Value Measurements and Disclosures.The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets and liabilities (Level 1) and lowest priority to unobservable inputs (Level 3). Assets and liabilities recorded in the condensed consolidated balance sheet at fair value are categorized based on a hierarchy of inputs, as follows:

Level 1unadjusted quoted prices in active markets for identical assets or liabilities;
Level 2quoted prices for similar assets or liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument; and
Level 3unobservable inputs for the asset or liability.

At September 30, 2013 and December 31, 2012, we had no assets or liabilities that were valued at fair value on a recurring basis.

Research and Development

Research and development, or R&D, expenses include internal R&D activities, external contract research organization, or CRO, services and their clinical research sites, and other activities. Internal R&D activity expenses include laboratory supplies, salaries, benefits, and non-cash share-based compensation expenses. CRO activity expenses include preclinical laboratory experiments and clinical trial studies. Other activity expenses include regulatory consulting, and regulatory legal counsel. Internal R&D activities and other activity expenses are charged to operations as incurred. We make payments to CROs based on agreed upon terms which may include payments in advance of a study starting date. Nonrefundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made. Advance payments to be expensed in future R&D activities were $1,940,675 and $189,375 at September 30, 2013 and December 31, 2012, respectively. We review and accrue CRO expenses and clinical trial study expenses based on services performed and rely on estimates of those costs applicable to the stage of completion of a study as provided by CRO. Accrued CRO costs are subject to revisions as such studies progress to completion. Revisions are charged to expense in the period in which the facts that give rise to the revision become known.

Earnings Per Share

We calculate earnings per share, or EPS, in accordance with ASC 260,Earnings Per Share, which requires the computation and disclosure of two EPS amounts, basic and diluted. We compute basic EPS based on the weighted average number of shares of common stock outstanding during the period. We compute diluted EPS based on the weighted average number of shares of common stock outstanding plus all potentially dilutive common shares outstanding during the period. Such potentially dilutive common

THERAPEUTICSMD, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

NOTE 2 – BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS (Continued)

 

Earnings Per Share (continued)

shares consist of stock options and warrants. Potentially dilutive common shares totaling 29,074,292 and 23,173,336 at September 30, 2013 and 2012, respectively, have been excluded from the diluted earnings per share calculation as they are anti-dilutive due to the net loss reported by us.

Recently Issued and Newly Adopted Accounting Pronouncements

 

OnIn July 18, 2013, the Financial Accounting Standards Board, or the FASB, issued Accounting Standards Update, or ASU, No. 2013-11,Income Taxes (Topic 740): Presentation of an Unrecognized Tax Benefit when a Net Operating Loss Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists (a consensus of the FASB Emerging Issues Task Force).,or ASU 2013-11. The amendments in this ASU 2013-11 provide guidance on the financial statementsstatement presentation of an unrecognized tax benefit when a net operating loss carryforward, a similar tax loss, or a tax credit carryforward exists. An unrecognized tax benefit should be presented in the financial statements as a reduction to a deferred tax asset for a net operating loss carryforward, a similar tax loss, or a tax credit carryforward with certain exceptions, in which case such an unrecognized tax benefit should be presented in the financial statements as a liability. The amendments in  this ASU No. 2013-11  do not require new recurring disclosures. The amendments in this ASU 2013-11 are effective for fiscal years, and interim periods within those years, beginning after December 15, 2013. The amendments in ASU No. 2013-11 aredid not expected to have a material impact on our condensed consolidated financial statements.

ReclassificationsIn December 2011, the FASB issued ASU No. 2011-11,Balance Sheet (Topic 210): Disclosures about Offsetting Assets and Liabilities, or ASU 2011-11.  ASU 2011-11  enhances current disclosures about financial instruments and derivative instruments that are either offset on the statement of financial position or subject to an enforceable master netting arrangement or similar agreement, irrespective of whether they are offset on the statement of financial position. Entities are required to provide both net and gross information for these assets and liabilities in order to facilitate comparability between financial statements prepared in conformity with GAAP and financial statements prepared on the basis of International Financial Reporting Standards. ASU 2011-11 is effective for annual reporting periods beginning on or after January 1, 2013, and interim periods within those years. ASU 2011-11 did not have a material impact on our financial position or results of operations.

 

Certain 2012 amountsWe do not believe there would have been reclassified to conform toa material effect on the accompanying condensed consolidated financial statements had any other recently issued, but not yet effective, accounting standards been adopted in the current year presentation.period.

NOTE 3 – INVENTORYSUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Impairment of Long-Lived Assets

We review the carrying values of property and equipment and long-lived intangible assets for impairment whenever events or changes in circumstances indicate that their carrying values may not be recoverable. Such events or circumstances include the following:

·significant declines in an asset’s market price;
·significant deterioration in an asset’s physical condition;
·significant changes in the nature or extent of an asset’s use or operation;
·significant adverse changes in the business climate that could impact an asset’s value, including adverse actions or assessments by regulators;
·accumulation of costs significantly in excess of original expectations related to the acquisition or construction of an asset;
·current-period operating or cash flow losses combined with a history of such losses or a forecast that demonstrates continuing losses associated with an asset’s use; and
7

THERAPEUTICSMD, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

Inventory consistsNOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)

Impairment of Long-Lived Assets (continued)

·expectations that it is more likely than not that an asset will be sold or otherwise disposed of significantly before the end of its previously estimated useful life.

If impairment indicators are present, we determine whether an impairment loss should be recognized by testing the applicable asset or asset group’s carrying value for recoverability. This test requires long-lived assets to be grouped at the lowest level for which identifiable cash flows are largely independent of the following:cash flows of other assets and liabilities, the determination of which requires judgment. We estimate the undiscounted future cash flows expected to be generated from the use and eventual disposal of the assets and compare that estimate to the respective carrying values in order to determine if such carrying values are recoverable. This assessment requires the exercise of judgment in assessing the future use of and projected value to be derived from the eventual disposal of the assets to be held and used. In our assessments, we also consider changes in asset utilization, including the temporary idling of capacity and the expected timing for placing this capacity back into production. If the carrying value of the assets is not recoverable, then we record a loss for the difference between the assets’ fair value and respective carrying values. We determine the fair value of the assets using an “income approach” based upon a forecast of all the expected discounted future net cash flows associated with the subject assets. Some of the more significant estimates and assumptions include market size and growth, market share, projected selling prices, manufacturing cost, and discount rate. We base estimates upon historical experience, our commercial relationships, market conditions, and available external information about future trends. We believe our current assumptions and estimates are reasonable and appropriate. Unanticipated events and changes in market conditions, however, could affect such estimates, resulting in the need for an impairment charge in future periods. There was no impairment of intangibles or long-lived assets during the three months ended March 31, 2014 and 2013.

  September 30,
2013
  December 31,
2012
 
Finished product $674,037  $1,124,739 
Raw material  291,035   380,000 
Deferred costs  182,514   110,471 
TOTAL INVENTORY $1,147,586  $1,615,210 

 

Fair Value of Financial Instruments

Our financial instruments consist primarily of accounts receivable, accounts payable, accrued expenses, and short-term debt. The carrying amount of accounts receivable, accounts payable, and accrued expenses approximates their fair value because of the short-term maturity of such instruments, which are considered Level 1 assets under the fair value hierarchy.

We categorize our assets and liabilities that are valued at fair value on a recurring basis into a three-level fair value hierarchy as defined by Accounting Standards Codification, or ASC, 820,Fair Value Measurements. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets and liabilities (Level 1) and lowest priority to unobservable inputs (Level 3). Assets and liabilities recorded in the consolidated balance sheet at fair value are categorized based on a hierarchy of inputs, as follows:

Level 1unadjusted quoted prices in active markets for identical assets or liabilities;
Level 2quoted prices for similar assets or liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument; and
Level 3unobservable inputs for the asset or liability.

At March 31, 2014 and December 31, 2013, we had no assets or liabilities that were valued at fair value on a recurring basis.

8
 

THERAPEUTICSMD, INC. AND SUBSIDIARIES


NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

NOTE 4 – INVENTORY

Inventory consists of the following:

  

March 31,

2014

  

December 31,

2013

 
Finished product $483,512  $621,679 
Raw material  257,761   250,943 
Deferred costs  179,412   170,996 
     TOTAL INVENTORY $920,685  $1,043,618 

 

NOTE 45 – OTHER CURRENT ASSETS

 

Other current assets consist of the following:

 September 30,
2013
 December 31,
2012
  

March 31,

2014

  

December 31,

2013

 
Prepaid vendor deposits $716,465  $—   
Prepaid research and development costs $1,940,675  $189,375   668,548   1,267,588 
Prepaid consulting  530,596   530,596 
Other receivables-related party (Note 14)  249,981   249,981 
Other prepaid costs  137,932   169,528 
Deferred financing costs  656,008      —     260,022 
Prepaid consulting  519,762   432,216 
Other receivables-related party (Note 11)  221,109    
Prepaid insurance  68,846   127,403 
Other prepaid costs  13,304    
Prepaid guaranty costs     2,944 
TOTAL OTHER CURRENT ASSETS $3,419,704  $751,938  $2,303,522  $2,477,715 

 

NOTE 56 – FIXED ASSETS

 

Fixed assets consist of the following:

 September 30,
2013
 December 31,
2012
  

March 31,

2014

  

December 31,

2013

 
Equipment $90,573  $67,668  $132,150  $108,458 
Furniture and fixtures  46,625   46,625   46,625   46,625 
Leasehold improvements  11,980   11,980 
  149,178   126,273   178,775   155,083 
Accumulated depreciation  (101,786)  (60,600)  (100,887)  (93,765)
TOTAL FIXED ASSETS $47,392  $65,673  $77,888  $61,318 

 

Depreciation expense for the ninethree months ended September 30,March 31, 2014 and 2013 was $7,122 and 2012 was $41,186 and $21,241,$4,703 respectively.

 

NOTE 67OTHER ASSETSPREPAID EXPENSE

 

Prepaid expense consistsconsisted of the following:

 September 30,
2013
 December 31,
2012
  

March 31,

2014

  

December 31,

2013

 
Prepaid consulting expense $952,870  $953,655 
Prepaid research and development costs $695,572  $824,221 
Prepaid manufacturing costs  899,000      899,000   899,000 
Prepaid accredited costs  18,133    
Accreted prepaid costs  36,388   27,234 
TOTAL PREPAID EXPENSE $1,870,003  $953,655  $1,630,960  $1,750,455 

 

9

Intangible assets consist of the following:

  September 30,
2013
  December 31,
2012
 
Patent costs $482,603  $224,971 
Website costs, net of amortization of  $86,923 and $77,159, respectively  5,671   14,584 
TOTAL INTANGIBLE ASSETS $488,274  $239,555 

Amortization expense for the nine months ended September 30, 2013 and 2012 was $9,764 and $22,711, respectively.

THERAPEUTICSMD, INC. AND SUBSIDIARIES


NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

NOTE 8 – INTANGIBLE ASSETS

The following table sets forth the gross carrying amount and accumulated amortization of our intangible assets as of March 31, 2014 and December 31, 2013:

  March 31, 2014 
  

 

Gross Carrying Amount

  

 

 

Accumulated Amortization

  

 

 

Net

Amount

  Weighted- Average Amortization Period (yrs.) 
Amortizing intangible assets:                
                 
   OPERA® software patent $31,951  $(999) $30,952   15.5 
                 
   Development costs of                
      corporate website  91,743   (91,743)  —     n/a 
                 
   Approved hormone                
      therapy drug                
      candidate patents  255,649   (3,364)  252,285   18.75 
                 
Non-amortizing intangible                
  assets:                
   Hormone therapy drug                

candidate patents

(pending)

  412,406   —     412,406   n/a 
                 
   Multiple trademarks for                
      vitamins/supplements  61,283   —     61,283   n/a 
      Total $853,032  $(96,106) $756,926     

10

THERAPEUTICSMD, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

NOTE 8 – INTANGIBLE ASSETS (Continued)

  December 31, 2013
  

 

Gross
Carrying Amount

 

 

 

Accumulated Amortization

 

 

 

Net

Amount

 Weighted- Average Amortization Period (yrs.)
Amortizing intangible assets:                
                 
   OPERA® software patent $31,951  $(499) $31,452   15.8 
                 
Development costs of corporate website  91,743   (89,661)  2,082   0.3 
                 
Non-amortizing intangible assets:                

Hormone therapy drug candidate patents (pending)

  572,726   —     572,726   n/a 
                 
Multiple trademarks for vitamins/supplements  59,328   —     59,328   n/a 
      Total $755,748  $(90,160) $665,588     

We amortize the intangible asset related to development costs for corporate website over 36 months, which is the prescribed life for software and website development costs. We amortize the intangible asset related to OPERA® using the straight-line method over the estimated remaining useful life of approximately 16 years, which is the life of the intellectual property patents. We amortize the approved hormone therapy drug candidate patents using straight-line method over the estimated remaining useful life of approximately 19 years. During the three months ended March 31, 2014 and 2013, there was no impairment recognized.

Amortization expense was $5,946 and $3,254 for the three months ended March 31, 2014 and 2013, respectively. Estimated amortization expense for the next five years is as follows:

Year Ending
December 31,
 

Estimated

Amortization

 2014 (9 months)  $11,589 
 2015  $15,452 
 2016  $15,452 
 2017  $15,452 
 2018  $15,452 

11

THERAPEUTICSMD, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

NOTE 79 – OTHER CURRENT LIABILITIES

 

Other current liabilities consist of the following:

  September 30,
2013
  December 31,
2012
 
Accrued offering costs $708,500  $ 
Accrued payroll and commission costs  408,491   397,210 
Accrued vacation costs  230,212   114,899 
Accrued professional fees  273,488   90,000 
Accrued royalty expense  219,786    
Allowance for coupons and returns  127,806   53,002 
Other accrued expenses  56,474   29,400 
Dividends payable(1)  41,359   41,359 
TOTAL OTHER CURRENT LIABILITIES $2,066,116  $725,870 
  

March 31,

2014

 

December 31,

2013

Accrued payroll and commission costs $444,749  $941,313 
Accrued vacation costs  387,908   256,920 
Allowance for wholesale distributor fees  290,780   306,303 
Accrued clinical research  205,000    
Accrued offering fees  165,000    
Accrued royalties  174,600   52,188 
Accrued clinical trial costs  93,215   129,208 
Allowance for coupons and returns  150,180   126,233 
Accrued rent  71,257    
Accrued legal and accounting expense  60,000   224,550 
Other accrued expenses(1)  229,284   177,900 
Accrued financing costs     850,000 
Accrued lab research     536,574 
     TOTAL OTHER CURRENT LIABILITIES $2,271,973  $3,601,189 

______________


(1)In June 2008, we declared and paid a special dividend of $0.40 per share of our common stock to all stockholders of record as of June 10, 2008. This amount reflects2008, of which $41,359 remained unclaimed dividends by certain stockholders.shareholders at March 31, 2014 and December 31, 2013.

 

NOTE 810 – NOTES PAYABLE

 

Issuance and Payment of Multiple Advance Revolving Credit Note

 

On January 31, 2013, we entered into a business loan agreement with Plato and Associates, LLC, a Florida limited liability company, or Plato, for a Multiple Advance Revolving Credit Note, or the PlatoRevolving Credit Note. The PlatoRevolving Credit Note allowsallowed us to draw down funding up to the $10 milliona $10,000,000 maximum principal amount, at a stated interest rate of 6% per annum. Plato maywas able to make advances to us from time to time under the PlatoRevolving Credit Note at our request, which advances will bewere of a revolving nature and maywere able to be made, repaid, and made from time to time. Interest payments will bewere due and payable on the tenth day following the end of each calendar quarter in which any interest iswas accrued and unpaid, commencing on April 10, 2013, and the principal balance outstanding under the PlatoRevolving Credit Note, together with all accrued interest and other amounts payable under the PlatoRevolving Credit Note, if any, will bewas due and payable on February 24, 2014. The PlatoRevolving Credit Note is was secured by substantially all of our assets. On each of February 25 and March 13, 2013, $200,000 was drawn against the PlatoRevolving Credit Note. On March 21, 2013, we repaid $401,085, includingwhich included accrued interest. As of September 30, 2013,interest, and there was no balance outstanding under the Plato Note.

Revolving Credit Note as of December 31, 2013 and February 24, 2014 when it expired. As additional consideration for the PlatoRevolving Credit Note, we issuedgranted to Plato a warrant to purchase 1,250,000 shares of our common stock at an exercise price of $3.20 per share (seeNOTE 9 – STOCKHOLDERS’ EQUITY for more details)(See Note 12).

 

Borrowing Under Amended Bank LOC

In February 2013, we borrowed $100,000, from First United Bank under the Amended Bank LOC (as defined inNOTE 11 – RELATED PARTIES). The Amended Bank LOC required a personal guarantee and cash collateral limited to $100,000 which was provided by Reich Family Limited Partnership, or Reich Family LP, an entity controlled by Mitchell Krassan, an officer of our company. On April 25, 2013, we paid the principal and interest due under the Amended Bank LOC of $100,735. On May 1, 2013, the Amended Bank LOC expired and was not renewed. Accordingly, the personal guarantee was canceled and the cash collateral was refunded to Reich Family LP.

12

 

THERAPEUTICSMD, INC. AND SUBSIDIARIES


NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

NOTE 8 – NOTES PAYABLE (Continued)

 

Issuance of Promissory NotesNOTE 11 – NET LOSS PER SHARE

 

In JanuaryWe calculate basic and February 2012, we sold 6% promissory notes for an aggregatediluted net loss per share allocable to common stockholders using the weighted-average number of $900,000 with a due dateshares of March 1, 2012. As discussed below inIssuance and Settlement of February 2012 Notes, these promissory notescommon stock outstanding during the period, less any shares subject to repurchase or forfeiture. There were modified on February 24, 2012 through the issuance of secured promissory notes, or the February 2012 Notes.

Issuance and Settlement of February 2012 Notes

On February 24, 2012, we issued the February 2012 Notes to an individual and an entity, or the Parties, both of which are our stockholders, in the principal base amounts of $1,358,014 and $1,357,110, respectively, and granted warrants for the purchase in the aggregate of 9,000,000no shares of our common stock outstanding subject to repurchase or the February Warrants, pursuant to the terms of a note purchase agreement, also dated February 24, 2012. As considerationforfeiture for the February 2012 Notesthree months ended March 31, 2014 and the February Warrants, we received an aggregate of $1,000,000 of new funding from the Parties and the Parties surrendered certain promissory notes previously issued by us in the aggregate amount of $1,700,000, plus accrued interest of $15,124. Under the February 2012 Notes, the Parties loaned us an additional $3,000,000 during March, April, and May 2012.2013.

 

On June 19, 2012,Since we settled $3,102,000are in principala net loss position, we have excluded outstanding stock options and interestrestricted stock units, all of the February 2012 Notes in exchangewhich are subject to forfeiture, as well as warrants for the exercise of 8,145,486 warrants. As discussed below inIssuance and Payment of June 2012 Notes, the remaining balance of $2,691,847 of the February 2012 Notes was modified on June 19, 2012 through the issuance of secured promissory notes, or the June 2012 Notes, (seeNOTE 9 – STOCKHOLDERS’ EQUITY,Warrants Issued in Connection with Debt, for more details).

Issuance and Payment of June 2012 Notes

On June 19, 2012, we issued the June 2012 Notes to the Parties in the principal base amounts of $2,347,128 and $2,344,719, respectively, pursuant to the terms of a note purchase agreement, or the June 2012 Note Purchase Agreement. As consideration for the June 2012 Notes, the Parties surrendered the remaining balance of the February 2012 Notes in the aggregate amount of $1,347,128 and $1,344,719, respectively (which sums included principle and interest through June 19, 2012), and we received an aggregate of $2,000,000 of new funding from the Parties, or theJune Funding. The principal base amount of each of the June 2012 Notes, plus any additional advance made to us thereafter, together with accrued interest at the annual rate of 6%, was due in one lump sum payment on February 24, 2014.As security for our obligations under the June 2012 Note Purchase Agreement and the June 2012 Notes, we entered into a security agreement and pledged all of our assets, tangible and intangible, as further described therein. We also granted warrants to purchase an aggregate of 7,000,000 shares of our common stock from our calculation of diluted net loss per share.

The table below presents the potentially dilutive securities that would have been included in connection withour calculation of diluted net loss per share allocable to common stockholders if they were not antidilutive for the June Funding.On March 21, 2013, we repaid $4,882,019, including accrued interest, leaving a balance of $21,595 in accrued interest as of March 31, 2013 related to the June 2012 Notes. On April 25, 2013, the balance of accrued interest was paid in full.periods presented.

  Three months ended 
  

March 31,

2014

  

March 31,

2013

 
Stock options  16,511,006   13,913,597 

Warrants

  14,293,499   13,443,499 

Restricted stock units

  50,000   —   
   30,854,505   27,357,096 

 

NOTE 912 – STOCKHOLDERS’ EQUITY

 

CommonPreferred Stock

 

At September 30, 2013,March 31, 2014, we had 10,000,000 shares of preferred stock, par value $0.001, authorized for issuance, of which no shares of preferred stock were issued or outstanding.

Common Stock

At March 31, 2014, we had 250,000,000 shares of common stock, $0.001 par value per share, authorized, with 144,962,706of which 145,067,060 shares of common stock were issued and outstanding.

 

Issuances During the Three Months Ended March 31, 2014

During the three months ended March 31, 2014, certain individuals exercised stock options to purchase 90,303 shares of our common stock. Stock options to purchase shares of our common stock were exercised as follows: (i) 88,736 shares for $40,055 in cash and (ii)1,567 shares, pursuant to the stock options’ cashless provision, wherein 1,433 options were cancelled.

13

THERAPEUTICSMD, INC. AND SUBSIDIARIES


NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

NOTE 912 – STOCKHOLDERS’ EQUITY (Continued)

 

Public OfferingsIssuances During the Year Ended December 31, 2013

On March 14, 2013, we entered into an underwriting agreement or the Jefferies Underwriting Agreement, with Jefferies LLC, or Jefferies, as the representative of the underwriters named therein, or the Jefferies Underwriters, relating to the issuance and sale of 29,411,765 shares of our common stock. The price to the public in the offering was $1.70 per share, and the Jefferies Underwriters agreed to purchase the shares of our common stock from us pursuant to the Jefferies Underwriting Agreementunderwriting agreement at a price of $1.58 per share. The net proceeds to us from this offering was approximately $45.4 million, after deducting underwriting discounts and commissions and other offering expenses payable by us. In addition, under the terms of the Jefferies Underwriting Agreement,underwriting agreement, we granted the Jefferies Underwriters a 30-day option to purchase up to an additional 4,411,765 shares of our common stock. The offering closed on March 20, 2013. On April 12, 2013, the Jefferies Underwriters exercised their option to purchase an additional 1,954,587 shares of our common stock to cover over-allotments. We issued these shares to the Jefferies Underwriters on April 18, 2013 and received proceeds of approximately $3.1 million, net of expenses.

 

On September 25, 2013, we entered into an underwriting agreement or the Stifel Underwriting Agreement with Stifel, Nicolaus & Company, Incorporated, as the representative of the several underwriters named therein, or the Stifel Underwriters, relating to the issuance and sale of 13,750,000 shares of our common stock. The price to the public in the offering was $2.40 per share, and the Stifel Underwriters agreed to purchase the shares of our common stock from us pursuant to the Stifel Underwriting Agreementunderwriting agreement at a price of $2.23 per share. The net proceeds to us from this offering were approximately $30.4$30.2 million, after deducting underwriting discounts and commissions and other offering expenses payable by us. The offering closed on September 30, 2013.

 

During 2013 certain individuals exercised their right to purchase shares of our common stock. Stock options to purchase an aggregate of 75,423 shares of our common stock were exercised for approximately $31,000.

Warrants to Purchase Common Stock of the Company

 

As of September 30, 2013,March 31, 2014, we had common stock purchase warrants outstanding forto purchase an aggregate of 14,293,499 shares of our common stock with a weighted averageweighted-average contractual remaining life of 4.53.7 years, and exercise prices ranging from $0.24 to $3.20 per share, resulting in a weighted average exercise price of $1.79 per share.

 

The valuation methodology used to determine the fair value of our warrants is the Black-Scholes-Merton option-pricingvaluation model, or the Black-Scholes Model, an acceptable model in accordance with ASC 718-10, Compensation – Stock Compensation.Model. The Black-Scholes Model requires the use of a number of assumptions, including volatility of the stock price, the risk-free interest rate and the term of the warrant.

 

Warrants Issued in Connection with DebtWarrant Activity During the Three Months Ended March 31, 2014

 

OnDuring the three months ended March 31, 2014, we did not grant any warrants.

14

THERAPEUTICSMD, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

NOTE 12 – STOCKHOLDERS’ EQUITY (Continued)

Warrant Activity During the Year Ended December 31, 2013

In January 31, 2013, we granted a warrant for thewarrants to purchase of 1,250,000 shares of our common stock in connection with the issuance of the PlatoRevolving Credit Note, or the Plato Warrant, (seeNOTE 8 – NOTES PAYABLE,Issuance and Payment of Multiple Advance Revolving Credit Note)10 for more details). The Plato Warrant has an exercise price of $3.20 per share. The Plato Warrant vested on October 31, 2013 and may be exercised prior to its expiration on January 31, 2019. The Plato Warrant,, with a fair value of approximately $1,711,956, was valued on the date of the grant using a term of six years; a volatility of 44.29%; risk free rate of 0.88%; and a dividend yield of 0%. At September 30, 2013, $656,008 was reported as deferred financing costs included in other current assets in the accompanying condensed consolidated balance sheet and is being amortized over the life of the Plato Note. For the ninethree months ended September 30,March 31, 2014 and 2013, $1,055,948$260,027 and $263,987, respectively was recorded as financing costs on the accompanying condensed consolidated financial statements.

 

12

THERAPEUTICSMD, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

NOTE 9 – STOCKHOLDERS’ EQUITY (Continued)

Warrants Issued in Connection with Debt (continued)

On June 19, 2012, we granted warrants for the purchase of an aggregate of 7,000,000 shares of our common stock in connection with the issuance of the June 2012 Notes, or the June 2012 Warrants, (seeNOTE 8 – NOTES PAYABLE,Issuance and Payment of June 2012 Notes). Of the June 2012 Warrants issued, 6,000,000 are exercisable at $2.00 per share and 1,000,000 are exercisable at $3.00 per share. The fair value of the June 2012 Warrants of $9,424,982 was determined by using the Black-Scholes Model on the date of the grant using a term of 5 years; a volatility of 44.64%; risk free rate of 0.75%; and a dividend yield of 0%.The relative fair value of the June 2012 Warrants of $1,649,890 was determined by using the relative fair value calculation method on the date of the grant. As a result of the repayment of the associated debt on March 21, 2013, we expensed the remaining unamortized debt discount of $885,709 at the time of the repayment.

On February 24, 2012, we issued warrants for the purchase of an aggregate of 5,685,300 shares of our common stock in connection with the modification of certain existing promissory notes, or the Modification Warrants, and warrants for the purchase of an aggregate of 3,314,700 shares of our common stock in connection with the issuance of the February 2012 Notes or the February 2012 Warrants (seeNOTE 8 – NOTES PAYABLE, Issuance and Settlement of February 2012 Notes). Both the Modification Warrants and the February 2012 Warrants are exercisable at $0.38 per share. The Modification Warrants’ fair value of $10,505,247 and the February 2012 Warrants’ fair value of $6,124,873 was determined by using the Black-Scholes Model on the date of the grant using a term of 5 years; a volatility of 44.5%; risk free rate of 0.89%; and a dividend yield of 0%. We recorded the fair value of the Modification Warrants as part of the loss on extinguishment of debt in the accompanying condensed consolidated financial statements.The relative fair value of the February 2012 Warrants of $859,647 was recorded as debt discount. As a result of the surrender of the February 2012 Notes on June 19, 2012, we expensed the remaining unamortized debt discount.

Warrants Issued for Services

OnIn May 7, 2013, we entered into a consulting agreement or the Agreement, with Sancilio & Company, Inc., or SCI, to develop drug platforms to be used in our hormone replacement drug products, or the Drug Products.candidates. These services include support of our efforts to successfully obtain U.S. FederalFood and Drug Administration, or the FDA, approval for the Drug Products,our drug candidates, including a vaginal capsule for the treatment of vulvar and vaginal atrophy, or VVA. In connection with the Agreement,agreement, SCI agreed to forfeit its rights to receive warrants for theto purchase of an aggregate of 833,000 shares of our common stock that were to be issuedgranted pursuant to the terms of a prior consulting agreement dated May 17, 2012. As consideration under the Agreement,agreement, we agreed to issuegrant to SCI a warrant to purchase 850,000 shares of our common stock at $2.01 per share that has vested or will vest, as applicable, as follows:

 

1.283,333 shares were earned on June 9,May 11, 2013 upon acceptance of an Investigational New Drug application by the FDA for the Drug Product for an estradiol-based productdrug candidate in a softgel vaginal capsule for the treatment of VVA; however, pursuant to the terms of the Agreement,consulting agreement, the shares did not vest until June 30, 2013.The fair value of $405,066 for the shares vested on June 30, 2013 was determined by using the Black-Scholes Model on the date of the vesting using a term of 5 years; a volatility of 45.89%; risk free rate of 1.12%; and a dividend yield of 0%. We recorded the entire$405,066 $405,066 as non-cash compensation in the accompanying condensed consolidated financial statements;as of June 30, 2013;

THERAPEUTICSMD, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

NOTE 9 – STOCKHOLDERS’ EQUITY (Continued)

Warrants Issued for Services (continued)

2.283,333 shares vested on June 30, 2013.The fair value of $462,196 for these shares was determined by using the Black-Scholes Model on the date of the vesting using a term of 5 years; a volatility of 45.84%; risk free rate of 1.41%; and a dividend yield of 0%. We recorded $154,068 as prepaid expense-short term and $308,128$192,577 as prepaid expense-long term in the accompanying condensed consolidated financial statements. During the three months ended September 30, 2013,March 31, 2014, we recorded $38,517 as non-cash compensation in the accompanying condensed consolidated financial statements; and
3.283,334 shares will vest upon the receipt by us of any final FDA approval of a Drug Productdrug candidate that SCI helped us design. It is anticipated that this event will not occur before December 2015.

 

In March 2012, we issued a warrant for the purchase of an aggregate of 31,000 shares of our common stock to five unaffiliated individuals for services rendered.These warrants were valued on the date of the grant using a term of 5 years; a volatility of 44.81%; risk free rate of 1.04%; and a dividend yield of 0%; $29,736 was recorded as consulting expense in the accompanying condensed consolidated financial statements.

A summary of our warrant activity and related information for 2013 follows:

  Number of Shares Under Company Warrants  Weighted Average Exercise Price  Weighted
Average
Remaining
Contractual
Life in Years
  Aggregate
Intrinsic Value
 
Balance at December 31, 2012  12,193,499  $1.63   4.8  $17,971,994 
Granted  2,100,000  $2.72   7.1  $782,000 
Exercised               
Expired               
Cancelled               
Balance at September 30, 2013  14,293,499  $1.79   4.5  $16,751,100 
Vested and Exercisable at September 30, 2013  12,190,468  $1.67   4.1  $15,499,537 

As of September 30, 2013, we had warrants outstanding with exercise prices ranging from $0.24 to $3.20 per share. As of September 30, 2013,March 31, 2014, unamortized costs associated with the warrants totaled approximately $2,129,000.$1.2 million.

 

Stock Options to Purchase Common Stock of the Company

 

On September 25, 2009, our board of directors approved the 2009 Long Term Incentive Compensation Plan, or the LTIP, to provide financial incentives to our employees, members of the Board,board of directors, and our advisers and consultants who are able to contribute towards the creation of or who have created stockholder value by providing them stock options and other stockequity and cash incentives, or the Awards.

15

THERAPEUTICSMD, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

NOTE 12 – STOCKHOLDERS’ EQUITY (Continued)

Stock Options to Purchase Common Stock of the Company (continued)

The Awards available under the LTIP consist of stock options, stock appreciation rights, restricted stock, restricted stock units, performance stock, performance units, EVA awards, and other stock or cash awards

THERAPEUTICSMD, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

NOTE 9 – STOCKHOLDERS’ EQUITY (Continued)

Stock Options (continued)

as described in the LTIP. There are 25,000,000 shares authorized for issuance under the LTIP. Under the LTIP, non-qualified stock options for the purchase of an aggregate of 13,155,79314,511,006 shares of our common stock were outstanding at September 30, 2013.March 31, 2014.

 

On February 23, 2012, our board adoptedof directors approved the 2012 Stock Incentive Plan, and on June 10, 2013, approved the Amended and Restated 2012 Stock Incentive Plan, or the 2012 SOP. The 2012 SOP was designed to serve as an incentive for retaining qualified and competent key employees, officers and directors, and certain consultants and advisors. There are 10,000,000 shares authorized for issuance under the 2012 SOP. Non-qualified stock options for the purchase of an aggregate of 1,625,0002,000,000 shares of our common stock and 50,000 restricted stock units were outstanding at September 30, 2013.March 31, 2014.

 

The valuation methodology used to determine the fair value of the stock options is the Black-Scholes Model. The Black-Scholes Model requires the use of a number of assumptions including volatility of the stock price, the risk-free interest rate, and the expected life of the stock options. The assumptions used in the Black-Scholes Model during the ninethree months ended September 30,March 31, 2014 and year ended December 31, 2013 are set forth in the table below.

 

 Nine Months
Ended
September 30, 2013
  Year
Ended
December 31, 2012
  

Three Months

Ended

March 31,

2014

  

Three Months

Ended

March 31,

2013

 
Risk-free interest rate  0.65-1.71%  0.61-2.23%  1.70-1.75%   0.77-0.81% 
Volatility  33.35-45.76%  40.77-46.01%  69.15-70.76%   43.01-44.94% 
Term (in years)  5-6.25   5-6.25   5.5-6.25   5.5-6.25 
Dividend yield  0.00%  0.00%  0.00%   0.00% 

 

The risk-free interest rate assumption is based upon observed interest rates on zero coupon U.S. Treasury bonds whose maturity period is appropriate for the expected life. Estimated volatility is a measure of the amount by which our stock price is expected to fluctuate each year during the term of thean award. Our estimated volatility is an average of the historical volatility of the stock prices of our peer entities whose stock prices were publicly available. Our calculation of estimated volatility is based on historical stock prices over a period equal to the term of the awards. We used the historical volatility of our peer entities due to the lack of sufficient historical data on our stock price. The average expected life is based on the contractual term of the stock option using the simplified method.

 

On September 4, 2013, we issued a 10-year stock option to a consultant for the purchase of an aggregate of 75,000 shares with an exercise price of $2.20. All of the shares available under the stock option will vest on the first anniversary of issuance.

On August 22, 2013, we issued a 10-year stock option to a director for the purchase of an aggregate of 50,000 shares with an exercise price of $2.16. The shares available under the stock option vest over a 3-year period on the anniversary of issuance.

On June 28, 2013, an individual exercised his stock option to purchase an aggregate of 61,372 shares of our common stock for an aggregate purchase price of $6,251.

1516
 

 

THERAPEUTICSMD, INC. AND SUBSIDIARIES


NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

NOTE 912 – STOCKHOLDERS’ EQUITY (Continued)

 

Stock Options (continued)

On June 21, 2013, we issued 10-year stock options to employees and consultants for the purchase of an aggregate of 632,500 shares with an exercise price of $2.98. An aggregate of 232,500 shares available under the stock options vest over a 3-year period on the anniversary of issuance, an aggregate of 100,000 shares vest monthly over an 18 month period, and an aggregate of 300,000 shares vest monthly over a 3-year period.

On May 10, 2013, we issued 10-year stock options to employees for the purchase of an aggregate of 100,000 shares with an exercise price of $2.71. An aggregate of 50,000 shares available under the stock options vest over a 4-year period on the anniversary of issuance and an aggregate of 50,000 shares vested immediately.

On May 6, 2013, we issued a 10-year stock option to a consultant for the purchase of an aggregate of 96,068 shares with an exercise price of $2.96. The shares available under the stock options vest monthly over a 12-month period.

On May 2, 2013, the Compensation CommitteePurchase Common Stock of the Board recommended the granting of stock options to our directors. The Board approved the recommendation and we issued 10-year stock options for the purchase of an aggregate of 575,000 shares of our common stock with an exercise price of $2.80, as follows: (i) a stock option for the purchase of 225,000 shares of our common stock to the Chairman of the Board; (ii) a stock option for the purchase of 75,000 shares of our common stock to the chair of each committee of the Board; and (iii) a stock option for the purchase of 50,000 shares of our common stock to each of the remaining directors. All of these stock options vest on December 31, 2013.

On May 8, 2013, Robert Finizio, our Chief Executive Officer, forfeited his contractual right to receive 600,000 shares upon exercise of a stock option granted in connection with his employment agreement as well as his right to receive any future stock options. Mr. Finizio gave up these rights with the understanding that these stock options would be returned to the pool of stock options available for issuance to attract future employees.

On March 29, 2013, we issued 10-year stock options to employees and consultants for the purchase of an aggregate of 180,109 shares with exercise prices ranging from $1.70 to $2.70. An aggregate of 500 shares available under the stock options vest over a 4-year period on the anniversary of issuance, an aggregate of 12,500 shares vest monthly over a 1-year period, 92,109 shares vest monthly over a 13-month period from the date of issuance, and an aggregate of 75,000 shares vest as follows: an aggregate of 31,250 vest immediately and an aggregate of 43,750 vest monthly over the subsequent seven months.

On September 13, 2012, we issued 10-year stock options to employees and consultants for the purchase of an aggregate of 391,750 shares with an exercise price of $3.40. An aggregate of 7,500 shares available under the stock options vest over a four-year period on anniversary of issuance, an aggregate of 115,000 shares vest over a two-year period on the anniversary of issuance, 2,500 shares vest over a one-year period on the anniversary of issuance, and 166,250 vest immediately.

On July 5, 2012, a consultant exercised a stock option to purchase 21,338 shares of our common stock at an exercise price of $0.19 per share. All shares under the stock option were purchased through a cashless exercise provision in which the consultant surrendered his right to receive 1,428 shares resulting in the

THERAPEUTICSMD, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

NOTE 9 – STOCKHOLDERS’ EQUITY (Continued)

Stock OptionsCompany (continued)

issuance of 19,910 shares. The shares are covered by a lock-up agreement. On July 11, 2012, a consultant exercised a stock option to purchase 30,685 shares of our common stock at an exercise price of $0.41 per share for a purchase price of $12,459.69. The shares are covered by a lock-up agreement.

On June 29, 2012, we issued 10-year stock options to employees, consultants, and a director for the purchase of an aggregate of 250,000 shares with an exercise price of $2.80. An aggregate of 7,500 shares available under the stock options vest over a 4-year period on the anniversary of issuance; an aggregate of 115,000 shares vest over a 2-year period on the anniversary of issuance; 2,500 shares vest over a 1-year period on the anniversary of issuance, 75,000 shares vest monthly from December 31, 2012; and 50,000 vested immediately.

On April 16, 2012, the Board approved the issuance of 10-year stock options for our directors for the purchase of: (i) an aggregate of 350,000 shares (50,000 shares each) to our directors for services to be rendered during calendar year 2012 and (ii) an aggregate of 75,000 shares (25,000 shares each) to the chair of each committee of the Board for services to be rendered during calendar year 2012. The stock options have an exercise price of $2.55 per share and vested in full on December 31, 2012. In addition, Dr. Brian Bernick, a director and employee, was issued a stock option for 150,000 shares for services rendered as an employee, having an exercise price of $2.55, which vested in full on April 16, 2013.

On March 30, 2012, we issued 10-year stock options to employees and consultants for the purchase of an aggregate of 480,000 shares with an exercise price of $2.40. An aggregate of 405,000 shares available under the stock options vest over a 4-year period on the anniversary of issuance; an aggregate of 60,000 shares vest over a 2-year period on the anniversary of issuance; and 15,000 shares vest monthly over a 12-month period from the date of issuance.

On March 30, 2012, the Board approved a cashless exercise provision for use by holders of stock options. Also on March 30, 2012, an individual exercised his option to purchase 245,485 shares of our common stock. The aggregate purchase price of approximately $60,000 was paid pursuant to a cashless exercise provision wherein the individual surrendered his right to receive 25,000 shares thereunder.

On February 27, 2012, we issued stock options to our officers and directors for the purchase of an aggregate of 600,000 shares with an exercise price of $2.20 per share. The stock options vested in full on February 27, 2013.

In January 2012, certain individuals exercised their stock options to purchase an aggregate of 1,630,022 shares of our common stock for an aggregate purchase price of $166,000.

THERAPEUTICSMD, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

NOTE 9 – STOCKHOLDERS’ EQUITY (Continued)

Stock Options (continued)

 

A summary of activity under the LTIP and 2012 SOP and related information follows:

 

 Number of Shares Under Company Option Weighted Average Exercise Price Weighted
Average
Remaining
Contractual
Life in Years
 Aggregate Intrinsic Value  Number of Shares Underlying Stock Options  Weighted Average Exercise
Price
  Weighted
Average
Remaining
Contractual
Life in Years
  Aggregate Intrinsic
Value
 
Balance at December 31, 2012  13,733,488  $1.16   7.7  $26,804,117 
Balance at December 31, 2013  15,632,742  $1.44   7.2  $58,878,132 
Granted  1,708,677  $2.75   9.6  $335,234   970,000  $5.05   9.8  $1,219,000 
Exercised  (61,372)              (90,303)            
Expired                 —               
Cancelled  (600,000)              (1,433)            
Balance at September 30, 2013  14,780,793  $1.27   7.6  $24,865,677 
Vested and Exercisable at September 30, 2013  10,101,920  $0.65   6.6  $22,803,024 
Balance at March 31, 2014  16,511,006  $1.66   7.4  $76,762,626 
Vested and Exercisable at March 31, 2014  11,397,538  $0.96   6.2  $60,999,179 

 

The Black Scholes methodBlack-Scholes Model is used to calculate the fair value of individual stock option grants on their issue date. The weighted-average issue date fair value of stock options issued during the ninethree months ended September 30, 2013March 31, 2014 was $1.06.

At September 30, 2013,$3.07. On that date, we had stock options outstanding with exercise prices ranging from $0.10 to $3.40$5.21 per share.

Share-based Stock-based compensation expense for stock options recognized in our results of operations for the ninethree months ended September 30,March 31, 2014 and 2013 were $820,383 and 2012 ($1,962,673$533,307, respectively, and $1,004,472, respectively) isstock-based expense for services for stock options recognized in our results of operations for the same periods were $185,642 and $66,653, respectively (all based on awards vested and was estimated without forfeitures.forfeitures). ASC 718-10 requires forfeitures to be estimated at the time of grant and revised in subsequent periods if actual forfeitures differ from the estimates.

At September 30, 2013,March 31, 2014, total unrecognized estimated compensation expense related to non-vestedunvested stock options previously issued prior to that date was approximately $3,521,000$6,105,000, which is expected to be recognized over a weighted-average period of 1.302.5 years. No tax benefit was realized due to a continued pattern of operating losses.

 

NOTE 1013 – INCOME TAXES

 

Deferred income tax assets and liabilities are determined based upon differences between the financial reporting and tax basis of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. We do not expect to pay any significant federal or state income tax for 20132014 as a result of (i) the losses recorded during the ninethree months ended September 30, 2013,March 31, 2014, (ii) additional losses expected for the remainder of 2013,2014, and/or (iii) net operating loss carry forwards from prior years. Accounting standards require the consideration of a valuation allowance for deferred tax assets if it is "more“more likely than not"not” that some component or all of the benefits of deferred tax assets will not be realized. As of September 30, 2013,March 31, 2014, we maintain a full valuation allowance for all deferred tax assets. Based on these requirements, no provision or benefit for income taxes has been recorded. There were no recorded unrecognized tax benefits at the end of the reporting period.

 

17

THERAPEUTICSMD, INC. AND SUBSIDIARIES


NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

NOTE 1114 – RELATED PARTIES

Loan Guaranty

In March 2011, VitaMed entered into a Business Loan Agreement and Promissory Note for a $300,000 bank line of credit, or the Bank LOC, for which the bank required personal guarantees and cash collateral. Personal guarantees and cash collateral limited to $100,000 each were provided by Robert Finizio and John Milligan, officers of VitaMed, and by Reich Family LP, an entity controlled by Mitchell Krassan, also an officer of VitaMed. The Bank LOC accrued interest at the rate of 3.02% per annum based on a year of 360 days and was due on March 1, 2012. On March 19, 2012, the bank and VitaMed negotiated a one year extension to the Bank LOC and a subsequent 2-month extension until May 1, 2013.

In consideration for the personal guarantees and cash collateral, we issued warrants for an aggregate of 613,713 shares. On November 13, 2012, we entered into an amendment with the bank to reduce the Bank LOC to $100,000, or the Amended Bank LOC. As part of the Amended Bank LOC, the personal guarantees and cash collateral for Mr. Finizio and Mr. Milligan were released. In accordance with the terms of the warrants, the warrants previously granted to Mr. Finizio and Mr. Milligan were amended to reflect the amount vested prior to the date of the Amended Bank LOC (179,000 each). At September 30, 2013, an aggregate of 562,571 warrants related to this loan guaranty were vested.

In February 2013, we borrowed $100,000 under the Amended Bank LOC. The Amended Bank LOC required a personal guarantee and cash collateral limited to $100,000 which was provided by Reich Family LP. On April 25, 2013, we paid the principal and interest due under the Amended Bank LOC of $100,735. On May 1, 2013, the Amended Bank LOC expired and was not renewed. Accordingly, the personal guarantee was canceled and the cash collateral was returned to Reich Family LP

Lock-Up Agreements

As required by the terms of the merger agreement with VitaMed dated July 18, 2011, we entered into Lock-Up Agreements, or the Agreements, with stockholders covering the aggregate of 70,000,000 shares of our common stock issued pursuant to this merger or reserved for issuance pursuant to stock options and warrants. Each stockholder agreed that from the date of the Agreements until 18 months thereafter, or the Lock-Up Period, they would not make or cause any sale of our common stock. After the completion of the Lock-Up Period, each stockholder agreed not to sell or dispose of more than 2.5% of their aggregate common stock or shares reserved for issuance under stock options and warrants per quarter over the following 12-month period, or the Dribble Out Period. Upon the completion of the Dribble Out Period, the Agreements will terminate.

Purchases by Related Parties

During the nine months ended September 30, 2013 and 2012, we did not sell any of our products to Dr. Brian Bernick, our Chief Medical Officer and director. At December 31, 2012, we had an outstanding receivable due from Dr. Bernick totaling $1,440, all of which has been paid.

Agreements with Pernix Therapeutics, LLC

 

On February 29, 2012, Cooper C. Collins, President andwho was then the largest stockholdershareholder of Pernix Therapeutics, LLC, or Pernix, was elected to serve on the Board. We entered intoour board of directors. On October 5, 2011, we closed a Stock Purchase Agreementstock purchase agreement with Pernix on October 4, 2011.Pernix. From time to time, we have entered into agreements with Pernix in the normal

19

THERAPEUTICSMD, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

NOTE 11 – RELATED PARTIES (Continued)

Agreements with Pernix Therapeutics, LLC (continued)

course of business primarily for the purchasebusiness. All such agreements are reviewed by independent directors or a committee consisting of inventory.independent directors. During the ninethree months ended September 30,March 31, 2014 and 2013, and 2012, we made purchases of approximately $0 and $96,250, respectively, fromdid not engage in any transactions with Pernix. At September 30, 2013March 31, 2014 and December 31, 2012,2013, there were outstanding amounts due to Pernix of approximately $46,464 and $308,000, respectively.$46,000.

 

Additionally, there were amounts due to us from Pernix for legal fee reimbursement in regardsrelating to the Acetoa litigation described inNOTE 13- COMMITMENTS AND CONTINGENCIES,matter stemming from a license and supply agreement in the amounts of 221,109 and $0 for the periods ending September 30, 2013$249,981 at both March 31, 2014 and December 31, 2012, respectively.2013.

 

NOTE 1215 - BUSINESS CONCENTRATIONS

 

We purchase our products from several suppliers with approximately 98%84% and 80%100% of our purchases supplied from one vendor for the ninethree months ended September 30,March 31, 2014 and 2013, and 2012, respectively.

 

We sell our prescription dietary supplement products to wholesale distributors, specialty pharmacies, specialty distributors, and chain drug stores that generally sell products to retail pharmacies, hospitals, and other institutional customers. Revenue generated from sales to threefour major customers Cardinal Health, Inc., Amerisource Bergen, and McKesson Corporation accounted for 63%97.42% and 42%99.46% of our recognized revenue for the ninethree months ended September 30,March 31, 2014 and 2013, respectively.

For the three months ended March 31, 2014 and 2012, respectively.2013, 81.75% and 70.44% of our recognized revenue and 96.08% and 99.46% of our deferred revenue was generated from sales to four major customers.

 

NOTE 1316 – COMMITMENTS AND CONTINGENCIES

Office Lease

 

We lease administrative office space in Boca Raton, Florida pursuant to a 63 month non-cancelable operating lease commencingthat commenced on July 1, 2013 and expiringexpires on September 30, 2018. The lease stipulates, among other things, average base monthly rents of $30,149 (inclusive of estimated operating expenses) and sales tax, for a total future minimum payments over the life of the lease of $1,899,414.

 

The straight line rental expense related to our current lease totaled $90,448 for the three months ended September 30, 2013.March 31, 2014 offset by rent income of $17,980. The rental expense related to our prior lease, which expired June 30, 2013 totaled $60,168$31,211 for the sixthree months ended June 30, 2013 and $84,114 for the nine months ended September 30, 2012, respectively.March 31, 2013.

 

LitigationAs of March 31, 2014, future minimum rental payments are as follows:

 

We are party to various legal actions arising in the ordinary course of business, including actions related to our intellectual property. While it is not feasible to determine the actual outcome of these actions at this time, we do not believe that these matters, including those described below, will have a material adverse effect on our consolidated financial condition, results of operations, or cash flows.

Years Ending

December 31,

   
 2014 (9 months)  $249,458 
 2015   371,240 
 2016   382,377 
 2017   393,848 
 2018   302,859 
 Total minimum lease payments  $1,699,782 
2018
 

THERAPEUTICSMD, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

NOTE 13 – COMMITMENTS AND CONTINGENCIES (Continued)

Litigation (continued)

Aceto Corporation

On November 13, 2012, Aceto Corporation filed a lawsuit against TherapeuticsMD and BocaGreen in the United States District Court for the Southern District of Florida seeking to enjoin us from using the Quatrefolic product and trademarks, among other things. We filed a motion to dismiss on January 2, 2013, which was granted by the court on July 17, 2013, based on Aceto’s failure to join the trademark owner, Gnosis, S.p.A. as a party plaintiff. On August 19, 2013, Aceto filed an amended complaint which purported to add Gnosis S.p.A. as an involuntary plaintiff. We have not yet filed a response to that amended complaint. As of September 11, 2013, the parties to this lawsuit reached a tentative settlement agreement, which is subject to and awaiting approval by Gnosis S.p.A. Based on our initial assessment of currently available information, we believe that the case is without merit and, as a result, should not have a material adverse effect on our consolidated financial condition, results of operations, or cash flows.

Avion Pharmaceuticals, LLC

On November 30, 2012, Avion Pharmaceuticals, LLC, filed a lawsuit against TherapeuticsMD and Bocagreen in the United States District Court for the Northern District of Georgia seeking to enjoin us from using the Prena1 name, among other things. Based on our assessment of the case which is in the discovery stage, we believe that the case is without merit and, as a result, should not have a material adverse effect on our consolidated financial condition, results of operations, or cash flows.

For additional information on these litigation matters, see our Annual Report on Form 10-K for the year ended December 31, 2012.

NOTE 14 – SUBSEQUENT EVENTS

On October 22, 2013, one of our financial advisors whose services we have engaged in prior transactions, or the Financial Advisor, filed a lawsuit against us in the Supreme Court of the State of New York, New York County. The lawsuit alleges that we breached our contractual obligations arising from an Engagement Letter entered into on June 25, 2012 between us and the Financial Advisor by failing to engage the Financial Advisor as a sole bookrunner and sole manager in an equity financing transaction that we closed on September 30, 2013. The lawsuit seeks to recover damages in the amount not less than $2.3 million, in addition to the costs and expenses incurred by the Financial Advisor in the litigation. We intend to defend this lawsuit vigorously. However, any litigation is subject to inherent uncertainties, and we cannot assure you that the expenses associated with defending this lawsuit or its resolution will not have a material adverse effect on our business, operating results, or financial condition.

 

Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations

 

General

 

The following discussion and analysis provides information that we believe to be relevant to an assessment and understanding of our results of operations and financial condition. This discussion should be read together with our condensed consolidated financial statements and the notes to the financial statements, which are included in this report. This information should also be read in conjunction with the information contained in our Annual Report on Form 10-K for the year ended December 31, 20122013 filed with the Securities and Exchange Commission, or the Commission or the SEC, on March 12, 2013,5, 2014, including the audited financial statements and notes included therein. The reported results will not necessarily reflect future results of operations or financial condition.

 

In addition, this Management’s Discussion and Analysis of Financial Condition and Results of Operations contains "forward-looking statements"“forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended or the Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act.These forward-looking statements include statements relating to our focus, goals, and intentions,intentions; our strategy for commercializing our proposed products, ourproducts;our belief in the advantages of our current line of products and proposed products over competitive products,products; the design of our drug candidates and our belief in thetheir attributes and benefits of our proposed products,benefits; clinical development of our products,drug candidates; our research and development expenditures,expenditures; and our belief that we have sufficient available cash and cash equivalents to fund our operations. Actual results could differ materially from those currently anticipated as a result of a number of factors, including those set forth under "Risk Factors"“Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2012.2013.

 

Throughout this Quarterly Report on Form 10-Q, the terms "we," "us," "our," "TherapeuticsMD,"“we,” “us,” “our,” “TherapeuticsMD,” or "our company"“our company” refer to TherapeuticsMD, Inc., a Nevada corporation, and unless specified otherwise, include our wholly owned subsidiaries, vitaMedMD, LLC, a Delaware limited liability company, or VitaMed, and BocaGreenMD, Inc., a Nevada corporation, or BocaGreen.

 

Overview

 

We are a women’s healthcarehealth care product company focused on creating and commercializing products targeted exclusively for women. We currently manufacture and distribute branded and generic prescription prenatal vitamins as well as over-the-counter vitamins and cosmetics. WeCurrently, we are currently focused on conducting the clinical trials necessary for regulatory approval and commercialization of advanced hormone therapy pharmaceutical products designedproducts. The current drug candidates used in our clinical trials are being investigated to alleviate the symptoms of and reduce the health risks resulting from menopause-related hormone deficiencies, including hot flashes, osteoporosis, and vaginal dryness. We are developing these proposedinvestigational hormone therapy products,drug candidates, which contain estradiol and progesterone alone or in combination, with the aim of providingdemonstrating equivalent clinical efficacy at lower doses, thereby enabling an enhanced side effect profile compared with competing products.

We intend to leverage and grow our current marketing and sales organization to commercialize our proposed products in the United States assuming the successful completion Our drug candidates are created from a platform of the U.S. Federal and Drug Administration, or FDA, regulatory process. We are also evaluating various other indications for our hormone technology including oral contraception, treatmentthat enables the administration of preterm birth,hormones with high bioavailability alone or in combination. In addition, we manufacture and premature ovarian failure.

The hormone therapy market includes two major components: an FDA-approved drug marketdistribute branded and a non-FDA approved drug market supplied by compounding pharmacies. We believe the FDA-approved products are easily measured and monitored, while non-FDA approved hormone therapy drug products, typically referred to as bioidenticals when produced by compounding pharmacies, are sold by compounding pharmacies and not monitored or easily measured. Our phase 3 trials are intended to establish an indication of the safety and efficacy of our proposed bioidentical products at specific dosage levels. We intend our proposed hormone therapy products, if approved, to provide an alternative to the non-FDA approved compounded bioidentical market based on our belief that our proposed products will offer advantages in terms of proven safety, efficacy, and stability, lower patient cost as a result of insurance coverage, and improved access as a result of availability from major retail pharmacy chains rather than custom order or formulation by individual compounders.

As we continue the clinical development of our proposed hormone therapy products, we continue to market our prescription and over-the-counter dietary supplement and cosmetic product lines, consisting of prenatal vitamins, iron supplements, vitamin D supplements, natural menopause relief products, and cosmetic stretch mark creams under our VitaMed brand name and duplicate formulations of ourgeneric prescription prenatal vitamins, products, also referred to as “generic” formulations, under our BocaGreen brand name. All of our prenatal vitamins are gluten-, sugar-, and lactose-free. We believe our product attributes result in greater consumer acceptance and satisfaction than competitive products while offering the highest quality and patented ingredients.

Our sales model focuses on the “4Ps”: patient, provider, pharmacist, and payor. We market and sell our current dietary supplement and cosmetic products primarily through a direct national sales force of approximately 30 full-time professionals that calls on healthcare providers in the obstetrics and gynecologic market space as well as through our website directly to consumers. In addition, our products allow healthcare providers to offer an alternative to patients to meet their individual nutritionalover-the-counter, or OTC, vitamins and financial requirements related to co-payment and cost-of-care considerations and help patients realize cost savings over competing products. We also believe that our combination of branded, generic, and over-the-counter lines offers physicians, women, and payors cost-effective alternatives for top-quality care. We supply our prescription dietary supplement products to consumers through retail pharmacies. We market our over-the-counter products either directly to consumers via our website and phone sales followed by home shipment or through physicians who then re-sell them to their patients. Our fully staffed customer care center uses current customer relationship management software to respond to healthcare providers, pharmacies, and consumers via incoming and outgoing telephone calls, e-mails, and live-chat. We also facilitate repeat customer orders for our non-prescription products through our website’s auto-ship feature.cosmetics.

 

Our common stock began trading on the NYSE MKT on April 23, 2013 under the symbol “TXMD” and was previously listed on the OTCQB. We maintain the following websites at www.therapeuticsmd.com, www.vitamedmd.com, www.vitamedmdrx.com, and www.bocagreenmd.com.

19

Research and Development

 

Overview

 

We have obtained the U.S. Food and Drug Administration, or FDA, acceptanceapproval of our Investigational New Drug, or IND, applications to conduct clinical trials for four of our proposed products: TX 12-001-HR, TX 12-002-HR, TX 12-003-HR,hormone therapy drug candidates: TX-001HR, our oral combination of progesterone and TX 12-004-HR. estradiol; TX-002HR, our oral progesterone alone; TX-003HR, our oral estradiol alone; and TX-004HR, our suppository estradiol alone.

We are currently conducting phase 3 clinical trials for TX-001HR and TX-002HR; and we currently intend to begin a phase 3 clinical trial for TX 12-001-HR; we currently intend to begin phase 3 clinical trials for TX 12-002-HR at the end of 2013; and we currently intend to begin phase 3 clinical trials for TX 12-004-HRTX-004HR in the secondthird quarter of 2014. We have no current plans forto conduct clinical trials for TX 12-003-HR.TX-003HR.

 

On September 5, 2013, we announced the enrollment and dosing of the first patient in the REPLENISH Trial, a phase 3 clinical trial designed to measure the safety and effectiveness of TX 12-001-HR in treating the symptoms of menopause and protecting the endometrium. We are also currently conducting formulation development ofTX-001HR, our proposed combination estradiol and progesterone product in a topical cream form.

TX 12-001-HR is ainvestigational combination estradiol and progesterone drug candidate, under developmentis undergoing clinical trials for the potential treatment of moderate to severe vasomotor symptoms due to menopause, including hot flashes, night sweats, sleep disturbances, and vaginal dryness, for post-menopausal women with an intact uterus. The product will bedrug candidate is chemically identical to the hormones that naturally occur in a woman’s body, namely estradiol and progesterone, and would beis being studied as a continuous-combined regimen (where(in which the combination of estrogen and progesterone are taken together in one product daily). If approved by the FDA, we believe this would represent the first time a combination product of theseestradiol and progesterone, biologically identical or bioidentical hormonesto the estradiol and progesterone produced by the ovaries, would be approved for use in a single combined product. We conducted a PK study of TX-001HR to evaluate the bioequivalency of our drug candidate to the reference listed drug based on the criterion that the 90% confidence interval on the test-to-reference ratio is contained entirely within the interval 80% to 125%. The study compared our combined capsule TX-001HR of 2 mg estradiol and 200 mg of progesterone to 2 mg of Estrace® and 200 mg of Prometrium®. We believe these data are sufficient to demonstrate the bioequivalence of TX-001HR to Estrace® and Prometrium®based on the criteria for demonstrating bioequivalence established in connection with the study. On September 5, 2013, we began enrollment of patients in the REPLENISH Trial, a phase 3 clinical trial designed to measure the safety and effectiveness of TX-001HR in the potential treatment of symptoms of menopause and protecting the endometrium.

 

TX 12-002-HRTX-002HR is aan investigational natural progesterone formulation without the potentially allergenic component of peanut oil. The product would be chemically identical to the hormones that naturally occur in a woman’s body. We believe it wouldwill be similarly effective to traditional treatments, but may demonstrate efficacy at lower dosages.

On May 10, 2013,dosages; however this must be confirmed in further clinical evaluation. In January 2014, we submitted an IND application to conduct clinical trials for TX 12-004-HR, which was accepted bybegan recruitment of patients in the FDA on June 9, 2013. On August 12, 2013, we announced that we initiatedSPRY Trial, a phase 13 clinical trial designed to measure the safety and effectiveness in the potential treatment of secondary amenorrhea. At the end of the fiscal quarter, the SPRY Trial encountered enrollment challenges because of Institutional Review Board approved clinical trial protocols and FDA inclusion and exclusion criteria.

TX-004HR is an investigational vaginal suppository estradiol drug candidate for TX 12-004-HR inthe potential treatment of vulvar and vaginal atrophy, or VVA, designed to measure the effect of TX 12-004-HR on certain clinical endpoints, including a study candidate’s pH levels, vaginal cytology, and the patient’s most bothersome symptom of VVA, out of the symptoms identified in FDA guidance. The study evaluated the efficacy and safety of a 10µg dose of TX 12-004-HR versus placebo over a two-week period in 48 postmenopausal women with symptoms of VVA. On October 22, 2013, we announced results of the phase 1 pilot study, which showed statistically significant differences between the treatment and placebo groups, with the treatment group showing changes in Maturation index (cell composition) and pH more closely resembling that found in premenopausal women with healthy, non-atrophied vaginal tissue.

TX 12-004-HR is a proposed suppository estradiol product for the treatment of VVA, in post-menopausal women with vaginal linings that do not receive enough estrogen. We believe that our proposed productdrug candidate will be as effective as the traditional treatments for VVA and we believethat it will have an added advantage of being a simple, easier to use dosage form versus most traditional VVA treatments.treatments; however this must be confirmed in further clinical evaluation. In August 2013, we initiated a phase 1 clinical trial for VVA, designed to measure the effect of TX-004HR on certain clinical endpoints, including a study candidate’s pH levels, vaginal cytology, and most bothersome symptom of VVA, out of the symptoms identified in FDA guidance. We are encouraged by our phase 1 results, and will continue to develop this investigational product that potentially differs from other drugs currently used to treat VVA.

20

Research and Development Expenses

 

A significant portion of our operating expenses to date have been incurred in research and development activities. Research and development expenses relate primarily to the discovery and development of our drug products. Our business model is dependent upon our company continuing to conduct a significant amount of research and development. Until one of our drug products receives IND approval from the FDA, products are listed as Other Research and Development cost.costs in the accompanying condensed consolidated financial statements. Our research and development expenses consist primarily of:of expenses incurred under agreements with contract research organizations, or CROs, investigative sites and consultants that conduct our clinical trials and a substantial portion of our preclinical studies; employee-related expenses, which include salaries and benefits, and non-cash share-based compensation; the cost of developing our chemistry, manufacturing and controls capabilities, or CMC, and acquiring clinical trial materials; and costs associated with other research activities and regulatory approvals.

 

Research and development costs are expensed as incurred.We make payments to the CROs based on agreed upon terms andthat may include payments in advance of a study starting date. Nonrefundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made. Advance payments to be expensed in future R&Dresearch and development activities were $1,940,675$668,548 and 189,375,1,267,588, at September 30, 2013March 31, 2014 and December 31, 2012,2013, respectively.

 

The following table indicates our research and development expense by project/category for the periods indicated (in thousands):

 

  Three Months Ended
September  30,
  Nine Months Ended
September  30,
 
  2013  2012  2013  2012 
TX 12-001-HR $1,902  $  $2,434  $ 
TX 12-002-HR  99      312    
TX 12-004-HR  729      733    
Other Research and Development  1,369   1,702   4,232   3,131 
Total $4,099  $1,702  $7,711  $3,131 

  Three Months Ended
March 31,
 
  2014  2013 
TX 001HR $2,894  $317 
TX 002HR  601   182 
TX 004HR  309    
Other research and development  2,104   1,066 
  $5,908  $1,565 

 

Research and development expenditures will continue to be significant and will increase as we continue development of our drug productscandidates and advance the development of our proprietary pipeline of novel drug products.candidates. We expect to incur significant research and development costs as we develop our drug pipeline, complete the ongoing clinical trials of our drug products,candidates, conduct our planned phase 3 clinical trials, subject to receiving input from regulatory authorities, and prepare regulatory submissions.

 

The costs of clinical trials may vary significantly over the life of a project owing to factors that include but are not limited to the following: per patient trial costs, the number of patients that participate in the trials; the number of sites included in the trials; the length of time each patient is enrolled in the trial; the number of doses that patients receive; the drop-out or discontinuation rates of patients; the amount of time required to recruit patients for the trial, the duration of patient follow-up; and the efficacy and safety profile of the drug candidate.

 

We base our expenses related to clinical trials on estimates that are based on our experience and estimates from CROs and other third parties.

 

Recent Events

Credit Line for $10 Million

On January 31, 2013, we entered into a business loan agreement with Plato and Associates, LLC, a Florida limited liability company, or Plato, for a Multiple Advance Revolving Credit Note, or the Plato Note. The Plato Note allows us to draw down funding up to the $10 million maximum principal amount, at a stated interest rate of 6% per annum. Plato may make advances to us from time to time under the Plato Note at our request, which advances will be of a revolving nature and may be made, repaid, and made from time to time. Interest payments will be due and payable on the tenth day following the end of each calendar quarter in which any interest is accrued and unpaid, commencing on April 10, 2013, and the principal balance outstanding under the Plato Note, together with all accrued interest and other amounts payable under the Plato Note, if any, will be due and payable on February 24, 2014. The Plato Note is secured by substantially all of our assets. On each of February 25 and March 13, 2013, $200,000 was drawn against the Plato Note. On March 21, 2013, we repaid $401,085, including accrued interest, and as of September 30, 2013, there was no balance outstanding under the Plato Note.

As additional consideration for the Plato Note, we issued Plato a warrant to purchase 1,250,000 shares of our common stock at an exercise price $3.20 per share. The warrant vested on October 31, 2013 and may be exercised at any time prior to its expiration on January 31, 2019.

New Lease Agreement

On July 1, 2013, we entered into a new lease for administrative office space located at 6800 Broken Sound Parkway in Boca Raton, Florida pursuant to a 63-month non-cancelable operating lease expiring on September 30, 2018. The lease stipulates, among other things, average base monthly rents of $30,149 (inclusive of estimated operating expenses) and sales tax, for a total future minimum payment over the life of the lease of $1,899,414.

Public Offering in September 2013

On September 25, 2013, we entered into an underwriting agreement, or the Stifel Underwriting Agreement, with Stifel, Nicolaus and Company, Incorporated, as representative of the underwriters named therein, or the September Underwriters, relating to the issuance and sale of 13,750,000 shares of our common stock. The price to the public in this offering was $2.40 per share and the September Underwriters agreed to purchase the shares from us pursuant to the Stifel Underwriting Agreement at a price of $2.232 per share. The net proceeds to us from this offering was approximately $30.4 million, after deducting underwriting discounts and commissions and other offering expenses payable by us. The offering was made pursuant to the registration statement on Form S-3 filed with the Commission on January 25, 2013, and deemed effective by the SEC on February 5, 2013, including prospectus supplements filed thereunder.

21

 

Results of Operations

 

The following information presents the results of operations for our continuing operations for the three and nine month periods ended September 30, 2013March 31, 2014 and 2012.2013. The following discussion of our financial condition and results of operations should be read in conjunction with our financial statements included herewith and our Annual Report on Form 10-K filed with the Commission on March 12, 2013.5, 2014. This discussion should not be construed to imply that the results discussed herein will necessarily continue into the future, or that any conclusion reached herein will necessarily be indicative of actual operating results in the future. Such discussion represents only our best present assessment. Our historical financial information presented for the three and nine month periods ended September 30,March 31, 2014 and 2013 and 2012 is reported on a consolidated basis with our subsidiaries.

 

Three months ended September 30, 2013March 31, 2014 compared with three months ended September 30, 2012March 31, 2013

 

 

Three Months Ended

September 30,

    

Three Months Ended

March 31,

   
 2013 2012 Change  2014  2013  Change 
 (000s)   (000s) 
Revenues, net $2,295  $1,036  $1,259  $2,831  $1,537  $1,294 
Cost of goods sold  649   307   342   831   380   451 
Operating expenses  8,883   4,640   4,243   10,951   6,100   4,851 
Operating loss  (7,237)  (3,911)  (3,326)  (8,951)  (4,943)  (4,008)
Other expense  (436)  (342)  (94)  (232)  (1,433)  1,201 
Net loss $(7,673) $(4,253) $(3,420) $(9,183) $(6,376) $(2,807)

 

Revenues and Cost of Goods Sold

Revenues for the three months ended September 30, 2013March 31, 2014 increased approximately $1,259,000,$1,294,000 or approximately 121%84%, from the three months ended September 30, 2012.March 31, 2013. This increase was directly attributable to the (i) increase in the number of physicians writing prescriptions for our products, (ii) the increased productivity of our sales force, and (iii) the increase in the average net sales price of our product, and (iv) the new prescription products introduced in March, April, May and November 2012.products. Approximately 31%33% of this increase was due to an increase in the number of units sold and approximately 69%67% of the increase was related to product mix. Cost of goods sold increased approximately $342,000,$451,000, or approximately 111%118%, for the three months ended September 30, 2013March 31, 2014 compared towith the three months ended September 30, 2012.March 31, 2013. Cost of goods sold as a percentage of revenue was 28%29% and 30%25% for the three months ended September 30,March 31, 2014 and 2013, and 2012, respectively. Our costs of individual products did not change for the three months ended September 30, 2013March 31, 2014 compared with the comparable period in 2012.2013.

 

Operating Expenses

Our principal operating costs include the following items as a percentage of total operating expenses.

 

 

Three Months Ended 

September 30,

  Three Months Ended
March 31,
 
 2013 2012  2014  2013 
Human resource costs, including salaries, commissions, benefits and taxes  32.6%  32.8%  23.6%  41.5%
Product design and development costs  46.1%  34.9%
Research and development costs  54.0%  25.6%
Sales and marketing, excluding human resource costs  16.7%  21.3%  13.2%  19.0%
Professional fees for legal, accounting and consulting  5.0%  5.9%  3.5%  7.3%
Other operating expenses  (0.4)%  5.1%  5.7%  6.6%

 

22

Operating expenses increased by approximately $4.2$4.9 million (91%(80%) as a result of the following items:

 

  (000s) (000s)
Increase in human resource costs, including salaries, commissions, benefits and taxes $1,372  $54 
Increase in research and development costs  2,479   4,343 
Increase in sales and marketing, excluding human resource costs  497   292 
Increase in legal, accounting and consulting fees  163 
Decrease in other operating expenses  (268)
Decrease in legal, accounting and consulting fees  (64)
Increase in other operating expenses  226 
 $4,243  $4,851 

 

Human resource costs, including salaries, commissions, benefits and taxes were higher as a result of increases in personnel between the two periods (approximately $837,000) and increasesan increase in non-cash compensation related to stock option awards (approximately $535,000)$217,000) offset partially by a decrease in personnel costs (approximately $163,000).

 

Product researchResearch and development costs increased as a direct result of the development of our hormone therapy productscandidates and associatedrelated clinical trials.

Professional fees increased primarily due to higher costs as a result of SEC reporting and additional requirements related to regulatory compliance.

 

Sales and marketing costs increased due to expanded client education.

Other Expense

Other non-operating expense increased by approximately $94,000 for the three months ended September 30, 2013 compared with the comparable period in 2012. This increase is 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.

Nine months ended September 30, 2013 compared with nine months ended September 30, 2012

  

Nine Months Ended

September 30,

  
  2013 2012 Change
       (000s)    
Revenues, net $5,913  $2,577  $3,336 
Cost of goods sold  1,493   1,015   478 
Operating expenses  22,217   12,315   9,902 
Operating loss  (17,797)  (10,753)  (7,044)
Loss on extinguishment of debt  —     (10,505)  10,505 
Beneficial conversion feature  —     (6,717)  6,717 
Other expense  (2,243)  (1,418)  (825)
Net loss $(20,040) $(29,393) $9,353 

Revenues and Cost of Goods Sold

Revenues for the nine months ended September 30, 2013 increased approximately $3,336,000, or approximately 129%, from the nine months ended September 30, 2012. This increase was directly attributable to the (i) increase in the number of physicians writing prescriptions for our product, (ii) the increased productivity of our sales force, (iii) increase in the average net sales price of our product, and (iv) the new prescription products introduced in March, April, May and November 2012. Approximately 20% of this increase was due to an increase in the number of units sold and approximately 80% of the increase was related to product mix. Cost of goods sold increased approximately $478,000, or approximately 47%, for the nine months ended September 30, 2013 compared with the nine months ended September 30, 2012. Cost of goods sold as a percentage of revenue was 25% and 39% for the nine months ended September 30, 2013 and 2012, respectively. Our costs of individual products did not change for the nine months ended September 30, 2013 compared with the comparable period in 2012.

Operating Expenses

Our principal operating costs include the following items as a percentage of total operating expenses:

  

Nine Months Ended

September 30,

 
  2013  2012 
Human resource costs, including salaries, commissions, benefits and taxes  38.7%  41.8%
Product research and development costs  34.7%  23.7%
Sales and marketing, excluding human resource costs  18.1%  26.5%
Professional fees for legal, accounting and consulting  5.7%  6.6%
Other operating expenses  2.8%  1.4%

Operating expenses increased by approximately $9.9 million (80%) as a result of expanded marketing, advertising, education, and training. We also incurred added costs associated with our new product distribution channels as well as the following items:

  (000s) 
Increase in human resource costs, including salaries, commissions, benefits and taxes $3,454 
Increase in research and development costs  4,795 
Increase in sales and marketing, excluding human resource costs  758 
Increase in legal, accounting and consulting fees  450 
Increase in other operating expenses  445 
  $9,902 

launch of new products in 2014.

 

Human resource costs, including salaries, commissions, benefitsProfessional fees decreased as a result of reduced expenditures on SEC reporting and taxes were higherregulatory compliance.

Other operating expense increased primarily as a result of increases in personnel between the two periods (approximately $1,754,000)rent and increases in non-cash compensation related to option awards (approximately $1,700,000).other occupancy expenses, administrative travel and entertainment expenses, and board of directors costs.

 

Product research and development costs increased as a direct result of the development of our hormone therapy products and associated clinical trials.

Professional fees increased primarily due to higher costs as a result of SEC reporting and additional requirements related to regulatory compliance.

Sales and marketing costs increased due to expanded client education.

Other Expense

Other non-operating expense decreased by approximately $16,396,000$1,200,000 for the ninethree months ended September 30, 2013March 31, 2014 compared with the comparable period in 2012.2013. This decrease iswas primarily a result of loss on extinguishmentthe reduction in amortization of debt and expense related to the beneficial conversion feature incurred during 2012 as herein described, partially offset by amortization of financing costs of approximately $1,108,000.

Loss on extinguishment of debt

In February 2012, we issued notes in the aggregate of approximately $2,700,000 and granted warrants for the purchase of an aggregate of 9,000,000 shares of our common stock. As consideration for these notes and warrants, we received an aggregate of $1,000,000 of new funding, or the New Funding, and the surrender of certain promissory notes previously issued by us in the aggregate amount of approximately $1,700,000. We determined that the resulting modification of the notes was substantially in accordance with Accounting Standards Codification 470-50,Modifications and Extinguishments. As such the modification was accounted for as an extinguishment and restructuring of debt, and the warrants issued, valued at approximately $10,500,000, were expensed as loss on extinguishment of debt. The relative fair value of the New Funding was estimated by calculating the present value of future cash flows discounted at a market rate of return for comparable debt instruments, to be $1,500,000. We recognized a reduction in loss on extinguishment of debt in the amount of $200,000, which represented the differencediscount recorded between the net carrying amount of the New Funding and its fair value.

Beneficial Conversion Feature

Beneficial conversion feature of approximately $6,717,000 consists of non-cash costs associated with the conversion of approximately $1,055,000 in debt into 2,775,415 shares of our common stock.periods.

 

Liquidity and Capital Resources

 

We incurred recurring net losses, including net losseshave funded our operations primarily through the private placement of approximately $20.0 millionequity, debt securities, and $29.4 million forpublic offerings of our common stock. For the nine months ended September 30, 2013 and 2012, respectively. Net cash outlays from operations and capital expenditures were approximately $16.3 million and $8.9 million for the nine months ended September 30, 2013 and 2012, respectively. As of September 30,year ending December 31, 2013, we had an accumulated deficitreceived approximately $79 million in net proceeds from the issuance of approximately $72.2 million and stockholders’ equity of $62.0 million. As of December 31, 2012, we had an accumulated deficit of approximately $52.1 million and a stockholders’ deficit of $1.4 million.

We need substantial amounts of cash to complete the clinical development of our proposed hormone therapy products. To fund the clinical development of our proposed hormone therapy products in March, April, and September, 2013, we sold an aggregate of 45,116,352 shares of our common stock in public offerings, through which we raised approximately $78.9 million, net of commissions and expenses.stock. As of September 30, 2013,March 31, 2014, we had approximately $60 million in cash and cash equivalents and a $10totaling approximately $45 million, line of credit available to us under the Plato Note.

Although we can provide no assurances, we believe our available cash and cash equivalents and the amount available under our line of credit will be sufficient to fund our operations, including the clinical development of our hormone therapy products for the next 12 months; however, changing circumstances may cause us to consume funds significantly faster than we currently anticipate, and we may need to spend more money than currently expected because of circumstances beyond our control.

 

We believe that our existing cash and cash equivalents will allow us to fund our operations through at least the next 12 months. If our available cash and cash equivalents are insufficient to satisfy our liquidity requirements, we are unablemay seek to sell additional equity or debt securities or obtain a credit facility. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. To the extent that we raise additional capital when requiredthrough the sale of equity or on acceptableconvertible debt securities, the ownership interest of our existing shareholders will be diluted, and the terms of these new securities may include liquidation or other preferences that adversely affect the rights of our existing shareholders. If we raise additional funds through collaborations, strategic alliances, or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs, or proposed products. Additionally, we may have to grant licenses on terms that may not be requiredfavorable to take one or moreus.

23

We need substantial amounts of cash to complete the clinical development of our hormone therapy drug candidates. The following table sets forth the primary sources and uses of cash for each of the following actions:periods set forth below:

 

significantly delay, scale back, or discontinue our product development and commercialization efforts;

Summary of (Uses) and Sources of Cash:

 

seek collaborators for our proposed hormone therapy products at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be the case; and

license, potentially on unfavorable terms, our rights to our proposed hormone therapy products that we otherwise would seek to develop or commercialize ourselves.
  Three Months Ended
March 31,
 
  2014  2013 
Net cash flows used in operating  activities $(8,705,937) $(3,508,682)
Net cash flows used in investing activities $(120,976) $(103,854)
Net cash flows provided by financing activities $40,055  $40,838,625 

 

Operating Activities

The use of cash in both periods resulted primarily from our net loss adjusted for non-cash charges and changes in components of working capital. The increase of approximately $5 million in cash used in operating activities for the period ended March 31, 2014 compared with the comparable period in the prior year was due primarily to research and development, and sales, general, and administrative costs. These were offset by an increase of approximately $1 million in sales over the same periods.

Investing Activities

The use of cash in both periods consisted of patent costs, security deposits, and purchase of property and equipment. There was virtually no change in cash used in investing activities for the period ended March 31, 2014 compared with the comparable period in 2013.

Financing Activities

Financing activities represent the principal source of our cash flow. Our financing activities for the period ended March 31, 2014, consisted of stock option exercises.

On March 14, 2013, we entered into an underwriting agreement. The net proceeds to us from this offering was approximately $45 million, after deducting underwriting discounts and commissions and other offering expenses. In addition, under the terms of the underwritten offering, we granted the underwriters a 30-day option to purchase additional shares of our common stock. In March 2013, we used the proceeds from the offering to repay approximately $5 million in notes and credit lines.

Off-Balance Sheet Arrangements

 

None.

 

Contractual Obligations

 

Other than the entry into a new lease agreement with respect to our corporate headquarters as disclosed inNOTE 1316COMMITMENTCOMMITMENTS AND CONTINGENCIES in the Notesnotes to the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q, there were no material changes in our commitments under contractual obligations.

24

New Accounting Pronouncements

 

NewIn July 2013, the FASB issued Accounting Pronouncements

There have been no material changesStandards Update, or ASU, No. 2013-11,Income Taxes (Topic 740): Presentation of an Unrecognized Tax Benefit when a Net Operating Loss Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists (a consensus of the FASB Emerging Issues Task Force),or ASU 2013-11. The amendments in ASU 2013-11 provide guidance on the financial statement presentation of an unrecognized tax benefit when a net operating loss carryforward, a similar tax loss, or a tax credit carryforward exists. An unrecognized tax benefit should be presented in the financial statements as a reduction to our significant accounting policiesa deferred tax asset for a net operating loss carryforward, a similar tax loss, or a tax credit carryforward with certain exceptions, in which case such an unrecognized tax benefit should be presented in the financial statements as summarizeda liability. The amendments in Note 2 of our Annual Report on Form 10-KASU No. 2013-11 do not require new recurring disclosures. The amendments in ASU 2013-11 are effective for the year endedfiscal years, and interim periods within those years, beginning after December 31, 2012. We do15, 2013. The amendments in ASU No. 2013-11 did not expect that the adoption of any recent accounting pronouncements will have a material impact on our condensed consolidated financial statements.

In December 2011, the FASB issued ASU No. 2011-11,Balance Sheet (Topic 210): Disclosures about Offsetting Assets and Liabilities, or ASU 2011-11. ASU 2011-11 enhances current disclosures about financial instruments and derivative instruments that are either offset on the statement of financial position or subject to an enforceable master netting arrangement or similar agreement, irrespective of whether they are offset on the statement of financial position. Entities are required to provide both net and gross information for these assets and liabilities in order to facilitate comparability between financial statements prepared in conformity with GAAP and financial statements prepared on the basis of International Financial Reporting Standards. ASU 2011-11 is effective for annual reporting periods beginning on or after January 1, 2013, and interim periods within those years. ASU 2011-11 did not have a material impact on our financial position or results of operations.

We do not believe there would have been a material effect on the accompanying consolidated financial statements had any other recently issued, but not yet effective, accounting standards been adopted in the current period.

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Item 3. Quantitative and Qualitative Disclosures about Market Risk

 

We had cash and cash equivalents totaling $1.6 million asOur market risk has not changed materially from the interest rate risk disclosed in Item 7A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2012. We hold our cash in money market funds and the primary objective of our investment policy is to preserve principal and maintain proper liquidity to meet operating needs. Our investment policy specifies credit quality standards for our investments and limits the amount of credit exposure to any single issue, issuer or type of investment. Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates. To minimize this risk, we intend to maintain a portfolio that may include cash, cash equivalents and investment securities available-for-sale in a variety of securities which may include money market funds, government and non-government debt securities and commercial paper, all with various maturity dates. Due to the low risk profile of our investments, an immediate 100 basis point change in interest rates would not h a material effect on the fair market value of our portfolio.2013.

We do not hold or issue derivatives, derivative commodity instruments or other financial instruments for speculative trading purposes. Further, we do not believe our cash equivalents and investment securities have significant risk of default or illiquidity. We made this determination based on discussions with our investment advisors and a review of our holdings. While we believe our cash equivalents and investment securities do not contain excessive risk, we cannot provide absolute assurance that in the future our investments will not be subject to adverse changes in market value. All of our investments are held at fair value.

 

Item 4. Controls and Procedures

 

Disclosure Controls and Procedures

 

Disclosure controls and procedures are designed to ensure that information required to be disclosed in the reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported, within the time period specified in the SEC's rules and forms and is accumulated and communicated to our principal executive officer and principal financial officer, as appropriate, in order to allow timely decisions in connection with required disclosure.

 

Evaluation of Disclosure Controls and Procedures

 

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures as of the end of the period covered by this Quarterly Report on Form 10-Q were effective in providing reasonable assurance that information required to be disclosed by us in reports that we file or submit under the Exchange Act is (i) recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and (ii) accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

 

Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures or our internal controls will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our company have been detected.

Changes in Internal Controls

 

During the three months ended September 30, 2013,March 31, 2014, there were no significant changes in our internal control over financial reporting that hashave materially affected, or isare reasonably likely to materially affect, our internal control over financial reporting, or other factors that could significantly affect these controls subsequent to the date of evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses.

 

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PART II - OTHER INFORMATION

Item 1.  Legal Proceedings

For a description of our legal proceedings, seeNOTE 13 – COMMITMENTS AND CONTINGENCIES in the Notes to the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.

 

Item 1A. Risk Factors

 

Our significant business risks are described in Part 1, Item 1A inof our Annual Report on Form 10-K for the year ended December 31, 20122013 filed with the Commission on March 12, 2013,5, 2014, to which reference is made herein. We do not believe that there have been any significant changes in our risk factors since that filing.

Item 2.  Unregistered Sales of Equity Securities and Use of Proceeds

None.

Item 3.  Defaults upon Senior Securities

None.

Item 4.  Mine Safety Disclosures

Not applicable.

 

Item 5. Other Information

 

None.Our 2014 Annual Meeting of the Stockholders has been moved to June 5, 2014. As such, the date of the Annual Meeting will have changed by more than 30 days from the anniversary of our 2013 Annual Meeting. In accordance with Rule 14a-5(f) and Rule 14a-8(e) under the Securities Act, we considered stockholder proposals submitted pursuant to Rule 14a-8 for inclusion in our proxy materials for the 2014 Annual Meeting to have been submitted in a timely fashion if we received such proposals no later than March 14, 2014. Such proposals should have been delivered by certified mail to the attention of the Corporate Secretary at TherapeuticsMD, Inc., 6800 Broken Sound Parkway NW, Third Floor, Boca Raton, FL 33487.

 

Item 6. Exhibits.

 

Exhibit

Date

Description

2.1July 6, 2009Agreement and Plan of Reorganization among Croff Enterprises, Inc., AMHN Acquisition Corp., America'sAmerica’s Minority Health Network, Inc., and the Major Shareholders(1)
2.2June 11, 2010Agreement and Plan of Reorganization among AMHN, Inc., SHN Acquisition Corp., Spectrum Health Network, Inc., and the Sole Shareholder of Spectrum Health Network, Inc.(2)
2.3October 25, 2007Croff Enterprises, Inc. Plan of Corporate Division and Reorganization(3)
2.4July 18, 2011Agreement and Plan of Merger among VitaMedMD, LLC, AMHN, Inc., and VitaMed Acquisition, LLC(4)
3.1September 15, 2009Articles of Amendment to Articles of Incorporation (to change name to AMHN, Inc.)(5)
3.2July 27, 2009Certificate of Merger of AMHN Acquisition Corp., with and into America'sAmerica’s Minority Health Network, Inc.(6)

3.3December 27, 2007Articles of Amendment to Articles of Incorporation of Croff Enterprises, Inc. (to increase authorized common shares from 20,000,000 to 50,000,000)(3)
3.4July 20, 2010Articles of Conversion of AMHN, Inc. filed in the State of Nevada(7)
3.5July 20, 2010Articles of Incorporation of AMHN, Inc. filed in the State of Nevada(7)
3.6August 29, 2011Certificate of Amendment and Restatement of the Articles of Incorporation of AMHN, Inc. (to change name and increase authorized shares)(8)
3.7n/aBylaws of AMHN, Inc.(9)
4.1September 26, 2012Form of Securities Purchase Agreement(10)
4.2n/aForm of Certificate of Common Stock(11)
10.1November 9, 2010Demand Promissory Note to Philip M. Cohen for $210,000(12)
10.2April 18, 2011Convertible Promissory Note to First Conquest Investment Group, LLCL.L.C. for $105,000(12)
10.3April 18, 2011Convertible Promissory Note to Energy Capital, LLC for $105,000(12)
10.4May 7, 2011Sales Representative Agreement between AMHN, Inc. and Mann Equity, LLC(12)
10.5July 9, 2009Lease Agreement between Liberty Property Limited Partnership and VitaMedMD, LLC(13)
10.6September 8, 2011Stock Purchase Agreement between AMHN, Inc. and Pernix Therapeutics, LLC(14)

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Exhibit

Date

Description

10.7September 8, 2011Lock-Up Agreement between AMHN, Inc. and Pernix Therapeutics, LLC(14)
10.8n/aForm of Common Stock Purchase Warrant(13)
10.910.9*n/aForm of Non-Qualified Stock Option Agreement(13)
10.10September 2011Form of Convertible Promissory Note(15)
10.11September 20, 2011Financing Agreement between Lang Naturals, Inc. and VitaMedMD, LLC(16)
10.12October 18, 2011Debt Conversion Agreement between the Company and Energy Capital, LLC(17)
10.13October 18, 2011Debt Conversion Agreement between the Company and First Conquest Investment Group, LLC(17)
10.14October 23, 2011Consulting Agreement among VitaMedMD, LLC, the Company, and Lang Naturals, Inc.(17)
10.15October 23, 2011Common Stock Purchase Warrant to Lang Naturals, Inc.(17)
10.16October 23, 2011Lock-Up Agreement between the Company and Lang Naturals, Inc.(17)
10.17November 3, 2011Software License Agreement between VitaMedMD,vitaMedMD, LLC and Pernix Therapeutics, LLDLLC(18)
10.18November 2011Form of Promissory Note(19)
10.19February 24, 2012Note Purchase Agreement among the Company, Plato & Associates, LLCInc., and Steven G. Johnson(20)
10.20February 24, 2012Form of Secured Promissory NotesNote(20)
10.21February 24, 2012Security Agreement among the Company, Plato & Associates, LLCInc., and Steven G. Johnson(20)
10.22February 24, 2012Form of Common Stock Purchase WarrantsWarrant(20)
10.23n/aAudit Committee Charter(21)
10.24n/aCompensation Committee Charter(21)
10.25n/aNominating and Corporate Governance Committee Charter(21)
10.26April 17, 2012Master Services Agreement between the Company and Sancilio and Company, Inc.(22)(21)
10.2710.27**May 17, 2012Consulting Agreement between the Company and Sancilio and Company, Inc.(22)* (21)
10.2810.28*November 8, 2012Form of Employment Agreement(23)(22)
10.29January 31, 2013Multiple Advance Revolving Credit Note, issued to Plato & Associates, LLC(24)(23)
10.30January 31, 2013Common Stock Purchase Warrant, issued to Plato & Associates, LLC(24)(23)
10.3110.31*May 8, 2013Agreement to Forfeit Non-Qualified Stock Options between the Company and Robert G. Finizio(25)(24)
10.32May 7, 2013Consulting Agreement between the Company and Sancilio and Company, Inc.(25) (24)
10.33May 16, 2013Lease between the Company and 6800 Broken Sound Parkway, LLC(26)(25)
10.34n/aAmended and Restated 2012 Stock Incentive Plan(27)(26)
10.3510.35*n/a2009 Long Term Incentive Compensation Plan, as amended(28)(27)
14.1n/aCode of Conduct and Ethics(21)
14.2n/aCode of Ethics for CEO and Senior Financial Officer(21)

14.3n/aInsider Trading Policy(29)
16.1December 14, 2011Letter to the Company from Parks & Company, LLC(30)
16.2February 1, 2012Letter to the SEC from Parks & Company, LLC(31)
2121.00December 31, 2012Subsidiaries of the Company(21)
31.123.1November 5, 2013March 4, 2014CertificationConsent of Chief Executive Officer of Periodic Report pursuant to Rule13a-14a and Rule 14d-14(a)**Rosenberg Rich Baker Berman & Company(21)
31.231.1November 5, 2013May 7, 2014Certification of Chief Financial Officer of Periodic Report pursuant to Rule13a-14a and Rule 14d-14(a)**
32.1November 5, 2013Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350**Rule 13a-14(a) and Rule 15d-14(a)
32.231.2November 5, 2013May 7, 2014Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350**Rule 13a-14(a) and Rule 15d-14(a)
101.INS32.1May 7, 2014Section 1350 Certification of Chief Executive Officer
32.2May 7, 2014Section 1350 Certification of Chief Financial Officer
101.INS†n/aXBRL Instance Document**Document
101.SCH101.SCH†n/aXBRL Taxonomy Extension Schema Document**Document
101.CAL101.CAL†n/aXBRL Taxonomy Extension Calculation Linkbase Document**Document
101.DEF101.DEF†n/aXBRL Taxonomy Extension Definition Linkbase Document**Instance Document
101.LAB101.LAB†n/aXBRL Taxonomy Extension Label Linkbase Document**Instance Document
101.PRE101.PRE†n/aXBRL Taxonomy Extension Presentation Linkbase Document**Instance Document

 

27


____________________________

*Indicates a contract with management or compensatory plan or arrangement.
**Certain information in this exhibit has been omitted and filed separately with the SEC.Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
**Filed herewith.
Pursuant to Rule 406TofRegulationS-T,theseinteractivedat406T of Regulation S-T, these interactive data files are deemed not filed or part of afilesaredeemednotfiledorpartofaregistrationstatementorprospectusforpurposes registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of Sections11or12oftheSecuritiesActof1933,as 18 of the Securities Exchange Act of 1934, as amended,,aredeemednotfiledforpurposesofSection18oftheSecuritiesExchangeActof1934,asamended,andotherwisearenotsubjecttoliabilityunderthose and otherwise are not subject to liability under those sections.

(1)File(1)dasanexhibittoForm8-K filedwiththeCommissiononJuly10,2009andincorporatedhereinbyreference.Filed as an exhibit to Form 8-K filed with the Commission on July 10, 2009 and incorporated herein by reference.
(2)File(2)dasanexhibittoForm8-K filedwiththeCommissiononJune14,2010andincorporatedhereinbyreference.Filed as an exhibit to Form 8-K filed with the Commission on June 14, 2010 and incorporated herein by reference.
(3)File(3)dasanexhibittoForm10-K fortheyearendedDecember31,2007filedwiththeCommissiononMay1,2008andincorporatedhereinbyreference.Filed as an exhibit to Form 10-K for the year ended December 31, 2007 filed with the Commission on May 1, 2008 and incorporated herein by reference.
(4)File(4)dasanexhibittoForm8-K filedwiththeCommissiononJuly21,2011andincorporatedhereinbyreference.Filed as an exhibit to Form 8-K filed with the Commission on July 21, 2011 and incorporated herein by reference.
(5)File(5)dasanexhibittoForm10-Q forquarterendedSeptember30,2009filedwiththeCommissiononNovember16,2009andincorporatedhereinbyreference.Filed as an exhibit to Form 10-Q for quarter ended September 30, 2009 filed with the Commission on November 16, 2009 and incorporated herein by reference.
(6)File(6)dasanexhibittoForm10-K fortheyearendedDecember31,2009filedwiththeCommissiononMarch17,2010andincorporatedhereinbyreference.Filed as an exhibit to Form 10-K for the year ended December 31, 2009 filed with the Commission on March 17, 2010 and incorporated herein by reference.
(7)File(7)dasanexhibittoForm10-Q forquarterendedJune30,2010filedwiththeCommissiononAugust3,2010andincorporatedhereinbyreference.Filed as an exhibit to Form 10-Q for quarter ended June 30, 2010 filed with the Commission on August 3, 2010 and incorporated herein by reference.
(8)Filed as an exhibit to Definitive 14C Information Statement filed with the Commission on September 12, 2011 and incorporated herein by reference.
(9)Filed as an exhibit to Definitive 14C Information Statement filed with the Commission on June 29, 2010 and incorporated herein by reference.
(10)Filed as an exhibit to Form 8-K filed with the Commission on October 2, 2012 and incorporated herein by reference.
(11)Filed as an exhibit to Form S-3 filed with the Commission on January 25, 2013 and incorporated hereby by reference.
(12)Filed as an exhibit to Form 10-Q for quarter ended March 31, 2011 filed with the Commission on May 19, 2011 and incorporated herein by reference.
(13)Filed as an exhibit to Form 8-K filed with the Commission on October 11, 2011 and incorporated herein by reference.

(14)Filed as an exhibit to Form 8-K filed with the Commission on September 14, 2011 and incorporated herein by reference.
(15)Filed as an exhibit to Form 8-K/A filed with the Commission on November 22, 2011 and incorporated herein by reference.
(16)Filed as an exhibit to Form 8-K/A filed with the Commission on February 2, 2012 and incorporated herein by reference.
(17)Filed as an exhibit to Form 8-K filed with the Commission on October 24, 2011 and incorporated herein by reference.
(18)Filed as an exhibit to Form 10-Q for quarter ended September 30, 2011 filed with the Commission on November 7, 2011 and incorporated herein by reference.
(19)Filed as an exhibit to Form 8-K filed with the Commission on November 23, 2011 and incorporated herein by reference.
(20)Filed as an exhibit to Form 8-K filed with the Commission on February 24, 2012 and incorporated herein by reference.
28
 
(21)File(21)dasanexhibittoForm10-K fortheyearendedDecember31,2012filedwiththeCommissiononMarch12,2013andincorporatedhereinbyreference.
(22)FiledasanexhibittoForm10-Q forquarterendedJune30,2012filedwiththeCommissiononAugust9,2012andincorporatedhereinbyreference.
(23)FiledasanexhibittoForm10-Q forquarterendedSeptember30,2012filedwiththeCommissiononNovember13,2012andincorporatedhereinbyreference.
(24)FiledasanexhibittoForm8-K filedwiththeCommissiononFebruary6,2013andincorporatedhereinbyreference.
(25)FiledasanexhibittoForm10-Q forquarterendedMarch31,2013filedwiththeCommissiononMay10,2013andincorporatedhereinbyreference.
(26)FiledasanexhibittoForm10-Q forquarterendedJune30,2013filedwiththeCommissiononAugust7,2013andincorporatedhereinbyreference.
(27)FiledasanexhibittoForm8-K filedwiththeCommissiononAugust 22, 2013andincorporatedhereinbyreference.
(28)FiledasanexhibittoForm S-8filedwiththeCommissionon October 15, 2013andincorporatedhereinbyreference.
(29)Filed as an exhibit to post-effective amendment on Form S-110-Q for quarter ended June 30, 2012 filed with the Commission on OctoberAugust 9, 2012 and incorporated herein by reference.
(22)Filed as an exhibit to Form 10-Q for quarter ended September 30, 2012 filed with the Commission on November 13, 2012 and incorporated herein by reference.
(23)Filed as an exhibit to Form 8-K filed with the Commission on February 6, 2013 and incorporated herein by reference.
(24)Filed as an exhibit to Form 10-Q for quarter ended March 31, 2013 filed with the Commission on May 10, 2013 and incorporated herein by reference.
(25)Filed as an exhibit to Form 10-Q for quarter ended June 30, 2013 filed with the Commission on August 7, 2013 and incorporated herein by reference.
(26)Filed as an exhibit to Form 8-K filed with the Commission on August 22, 2013 and incorporated herein by reference.
(27)Filed as an exhibit to Registration Statement on Form S-8 filed with the Commission on October 15, 2013 and incorporated herein by reference.

29
 
(30)FiledasanexhibittoForm8-K filedwiththeCommissiononJanuary 25, 2012andincorporatedhereinbyreference.
(31)FiledasanexhibittoForm8-K/A filedwiththeCommissiononFebruary 3, 2012andincorporatedhereinbyreference.

 

SIGNATURES

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

DATE: November 5, 2013

May 7, 2014

THERAPEUTICSMD, INC.
By:/s/ Robert G. Finizio
Robert G. Finizio
Chief Executive Officer
(Principal Executive Officer)
   
 By:/s/ Robert G. Finizio

Robert G. Finizio Chief Executive Officer
(Principal Executive Officer)

By:/s/ Daniel A. Cartwright
  Daniel A. Cartwright
Chief Financial Officer

(Principal Financial and Accounting Officer)

 


30