Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2016 | Aug. 01, 2016 | |
Document And Entity Information | ||
Entity Registrant Name | TherapeuticsMD, Inc. | |
Entity Central Index Key | 25,743 | |
Document Type | 10-Q | |
Trading Symbol | TXMD | |
Document Period End Date | Jun. 30, 2016 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Is Entity a Well-known Seasoned Issuer? | No | |
Is Entity a Voluntary Filer? | No | |
Is Entity's Reporting Status Current? | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 196,492,195 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2,016 |
CONSOLIDATED BALANCE SHEETS (Un
CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($) | Jun. 30, 2016 | Dec. 31, 2015 |
Current Assets: | ||
Cash | $ 166,532,446 | $ 64,706,355 |
Accounts receivable, net of allowance for doubtful accounts of $529,298 and $81,910, respectively | 4,477,308 | 3,049,715 |
Inventory | 883,656 | 690,153 |
Other current assets | 2,136,735 | 2,233,897 |
Total current assets | 174,030,145 | 70,680,120 |
Fixed assets, net | 444,412 | 198,592 |
Other Assets: | ||
Intangible assets, net | 1,983,829 | 1,615,251 |
Prepaid expense | 1,109,883 | |
Security deposit | 129,864 | 125,000 |
Total other assets | 2,113,693 | 2,850,134 |
Total assets | 176,588,250 | 73,728,846 |
Current Liabilities: | ||
Accounts payable | 3,039,388 | 3,126,174 |
Other current liabilities | 6,299,783 | 7,539,526 |
Total current liabilities | 9,339,171 | 10,665,700 |
Total liabilities | 9,339,171 | 10,665,700 |
Commitments and Contingencies -See Note 15 | ||
Stockholders' Equity: | ||
Preferred stock - par value $0.001; 10,000,000 shares authorized; no shares issued and outstanding | ||
Common stock - par value $0.001; 350,000,000 shares authorized; 196,492,195 and 177,928,041 issued and outstanding, respectively | 196,492 | 177,928 |
Additional paid in capital | 428,902,951 | 282,712,078 |
Accumulated deficit | (261,850,364) | (219,826,860) |
Total stockholders' equity | 167,249,079 | 63,063,146 |
Total liabilities and stockholders' equity | $ 176,588,250 | $ 73,728,846 |
CONSOLIDATED BALANCE SHEETS (U3
CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - USD ($) | Jun. 30, 2016 | Dec. 31, 2015 |
Statement of Financial Position [Abstract] | ||
Allowance for doubtful accounts | $ 529,298 | $ 81,910 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 350,000,000 | 350,000,000 |
Common stock, shares issued | 196,492,195 | 177,928,041 |
Common stock, shares outstanding | 196,492,195 | 177,928,041 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Income Statement [Abstract] | ||||
Revenues, net | $ 4,403,247 | $ 4,847,934 | $ 9,333,338 | $ 9,322,983 |
Cost of goods sold | 1,130,108 | 1,033,089 | 2,238,551 | 2,076,730 |
Gross profit | 3,273,139 | 3,814,845 | 7,094,787 | 7,246,253 |
Operating expenses: | ||||
Sales, general, and administration | 10,619,006 | 6,865,442 | 20,297,558 | 13,029,054 |
Research and development | 13,841,193 | 24,190,714 | 28,938,210 | 42,367,549 |
Depreciation and amortization | 24,262 | 14,280 | 43,859 | 27,852 |
Total operating expense | 24,484,461 | 31,070,436 | 49,279,627 | 55,424,455 |
Operating loss | (21,211,322) | (27,255,591) | (42,184,840) | (48,178,202) |
Other income: | ||||
Miscellaneous income | 114,320 | 25,585 | 155,937 | 44,098 |
Accreted interest | 2,863 | 2,560 | 5,399 | 12,402 |
Total other income | 117,183 | 28,145 | 161,336 | 56,500 |
Loss before taxes | (21,094,139) | (27,227,446) | (42,023,504) | (48,121,702) |
Provision for income taxes | ||||
Net loss | $ (21,094,139) | $ (27,227,446) | $ (42,023,504) | $ (48,121,702) |
Net loss per share, basic and diluted (in dollars per share) | $ (0.11) | $ (0.16) | $ (0.21) | $ (0.29) |
Weighted average number of common shares outstanding (in shares) | 196,325,715 | 172,782,264 | 195,613,639 | 168,734,760 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (42,023,504) | $ (48,121,702) |
Adjustments to reconcile net loss to net cash flows used in operating activities: | ||
Depreciation of fixed assets | 19,216 | 14,248 |
Amortization of intangible assets | 24,643 | 13,604 |
Provision for doubtful accounts | 447,388 | 30,767 |
Share-based compensation | 9,200,844 | 2,968,811 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (1,874,980) | (1,190,068) |
Inventory | (193,503) | (66,606) |
Other current assets | 1,001,120 | 383,194 |
Other assets | (12,410) | |
Accounts payable | (86,786) | (508,511) |
Deferred revenue | (522,613) | |
Other current liabilities | (1,239,743) | 2,047,264 |
Other long-term liabilities | 967,286 | |
Net cash used in operating activities | (34,725,305) | (43,996,736) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Patent costs | (393,221) | (78,792) |
Purchase of fixed assets | (265,036) | (15,559) |
Payment of security deposit | (4,864) | |
Net cash used in investing activities | (663,121) | (94,351) |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Proceeds from sale of common stock, net of costs | 134,863,475 | 59,117,827 |
Proceeds from exercise of warrants | 1,373,000 | 366,000 |
Proceeds from exercise of options | 978,042 | 491,351 |
Net cash provided by financing activities | 137,214,517 | 59,975,178 |
Increase in cash | 101,826,091 | 15,884,091 |
Cash, beginning of period | 64,706,355 | 51,361,607 |
Cash, end of period | $ 166,532,446 | $ 67,245,698 |
THE COMPANY
THE COMPANY | 6 Months Ended |
Jun. 30, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
THE COMPANY | NOTE 1 THE COMPANY TherapeuticsMD, Inc., a Nevada corporation, or TherapeuticsMD or the Company, has three wholly owned subsidiaries, vitaMedMD, LLC, a Delaware limited liability company, or VitaMed; BocaGreenMD, Inc., a Nevada corporation, or BocaGreen; and VitaCare Prescription Services, Inc., a Florida corporation, or VitaCare. Unless the context otherwise requires, TherapeuticsMD, VitaMed, BocaGreen, and VitaCare collectively are sometimes referred to as our company, we, our, or us. Nature of Business We are a womens health care product company focused on creating and commercializing products targeted exclusively for women. As of the date of these unaudited consolidated financial statements, we are focused on conducting the clinical trials necessary for regulatory approval and commercialization of our advanced hormone therapy pharmaceutical products. The 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 discomfort. We are 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. |
BASIS OF PRESENTATION AND RECEN
BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS | 6 Months Ended |
Jun. 30, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS | NOTE 2 BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS Interim Financial Statements The accompanying unaudited interim consolidated financial statements of TherapeuticsMD, Inc., which include our wholly owned subsidiaries, should be read in conjunction with the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2015, as filed with the Securities and Exchange Commission, or the SEC, from which we derived the accompanying consolidated balance sheet as of December 31, 2015. The accompanying unaudited interim consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, 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 unaudited interim consolidated financial statements do not include all of the information and notes required by GAAP for complete financial statements. The accompanying unaudited interim consolidated 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 or any other interim period in the future. Recently Issued Accounting Pronouncements In March 2016, the Financial Accounting Standards Board, or FASB, issued ASU 2016-09, Compensation Stock Compensation: Improvements to Employee Share-Based Payment Accounting. This guidance simplifies several aspects of the accounting for employee share-based payment transactions for both public and nonpublic entities, including the accounting for income taxes, forfeitures, and statutory tax withholding requirements, as well as classification in the statement of cash flows. The guidance is effective for public business entities for fiscal years beginning after December 15, 2016, and interim periods within those fiscal years. Early adoption is permitted in any annual or interim period for which financial statements have not been issued or made available for issuance, but all of the guidance must be adopted in the same period. If an entity early adopts the guidance in an interim period, any adjustments must be reflected as of the beginning of the fiscal year that includes that interim period. We are currently evaluating the impact of this guidance on our consolidated financial statements and disclosures. In February 2016, the FASB issued ASU 2016-02, Leases. This guidance requires lessees to record most leases on their balance sheets but recognize expenses on their income statements in a manner similar to current accounting. The guidance also eliminates current real estate-specific provisions for all entities. For lessors, the guidance modifies the classification criteria and the accounting for sales-type and direct financing leases. The standard is effective for public business entities for annual periods beginning after December 15, 2018, and interim periods within those years. Early adoption is permitted for all entities. We are currently evaluating the impact of this guidance on our consolidated financial statements and disclosures. In July 2015, the FASB issued ASU 2015-11, Inventory (Topic 330), simplifying the Measurement of Inventory. This guidance requires entities to measure inventory at the lower of cost or net realizable value rather than at the lower of cost or market (LOCOM). The guidance applies only to inventories for which cost is determined by methods other than last-in first-out (LIFO) or the retail inventory method (RIM). Entities that use LIFO or RIM will continue to use existing impairment models. The new guidance does not change the calculation of net realizable value that entities are required to calculate when applying existing LOCOM guidance. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal and transportation. Under the new guidance, however, entities will no longer need to calculate other measures of market. The guidance is effective for public business entities for fiscal years beginning after December 15, 2016, and interim periods within those fiscal years. Early adoption is permitted. We are currently evaluating the impact of this guidance, if any, on our consolidated financial statements and disclosures. In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements-Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entitys Ability to Continue as a Going Concern. ASU 2014-15 requires management to evaluate whether there are conditions and events that raise substantial doubt about the entitys ability to continue as a going concern within one year after the financial statements are issued (or available to be issued when applicable) and, if so, disclose that fact. ASU 2014-15 is effective for annual periods ending after December 15, 2016 and interim periods within annual periods beginning after December 15, 2016. Early adoption is permitted for annual or interim reporting periods for which the financial statements have not previously been issued. We do not expect the adoption of ASU 2014-15 to have a material effect on our consolidated financial statements and disclosures. In May 2014, the FASB and the International Accounting Standards Board (IASB) issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606). The standards core principle is that a company will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. In doing so, companies will need to use more judgment and make more estimates than under previous guidance. These may include identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance obligations. In July 2015, the FASB approved the proposal to defer the effective date of ASU 2014-09 standard by one year. Early adoption is permitted after December 15, 2016, and the standard is effective for public entities for annual reporting periods beginning after December 15, 2017 and interim periods therein. In 2016, the FASB issued final amendments to clarify the implementation guidance for principal versus agent considerations (ASU 2016-08) as well as accounting for licenses of intellectual property and identifying performance obligations (ASU 2016-10) and narrow-scope improvements and practical expedients (ASU 2016-12) in its new revenue standard. We are currently evaluating the impact of this guidance on our consolidated financial statements and disclosures. 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. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 6 Months Ended |
Jun. 30, 2016 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 3 SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Fair Value of Financial Instruments Our financial instruments consist primarily of accounts receivable, accounts payable and accrued expenses. 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. Level 1 unadjusted quoted prices in active markets for identical assets or liabilities; Level 2 quoted 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 3 unobservable inputs for the asset or liability. At June 30, 2016 and 2015, we had no assets or liabilities that were valued at fair value on a recurring basis. The fair value of indefinite-lived assets or long-lived assets is measured on a non-recurring basis using significant unobservable inputs (Level 3) in connection with our impairment test. There was no impairment of intangible assets or long-lived assets during the three and six months ended June 30, 2016 and 2015. Revenue Recognition We recognize revenue on arrangements in accordance with ASC 605, Revenue Recognition. We recognize revenue only when the price is fixed or determinable, persuasive evidence of an arrangement exists, the service is performed, and collectability is reasonably assured. Our OTC and prescription prenatal vitamin products are generally variations of the same product with slight modifications in formulation and marketing. The primary difference between our OTC and prescription prenatal vitamin products is the source of payment. Purchasers of our OTC prenatal vitamin products pay for the product directly while purchasers of our prescription prenatal vitamin products pay for the product primarily via third-party payers. Both OTC and prescription prenatal vitamin products share the same marketing support team utilizing similar marketing techniques. The revenue that is generated by us from major customers is all generated from sales of our prescription prenatal vitamin products which is disclosed in Note 14. There are no major customers for our OTC prenatal vitamin or other products. Over-the-Counter Products We generate OTC revenue from product sales primarily to retail consumers. We recognize revenue from product sales upon shipment, when the rights of ownership and risk of loss have passed to the consumer. We include outbound shipping and handling fees in revenues, net, and bill them upon shipment. We include shipping expenses in cost of goods sold. A majority of our OTC customers pay for our products with credit cards, and we usually receive the cash settlement in two to three banking days. Credit card sales minimize accounts receivable balances relative to OTC sales. We provide an unconditional 30-day money-back return policy under which we accept product returns from our retail and eCommerce OTC customers. We recognize revenue from OTC sales, net of estimated returns, sales discounts, and eCommerce fees. Prescription Products We sell our name brand and generic prescription products primarily through drug wholesalers and retail pharmacies. We recognize revenue from prescription product sales, net of sales discounts, chargebacks, and customer rebates. We accept returns of unsalable prescription products from customers within a return period of six months prior to and up to 12 months following product expiration. Our prescription products currently have a shelf life of 24 months from the date of manufacture. We estimate returns based on historical return rates and recorded actual product returns against this reserve as received. We offer various rebate programs in an effort to maintain a competitive position in the marketplace and to promote sales and customer loyalty. The consumer rebate program is designed to enable the end user to submit a coupon to us. If the coupon qualifies, we send a rebate check to the end user. We estimate the allowance for consumer rebates that we have offered based on our experience and industry averages, which is reviewed, and adjusted if necessary, on a quarterly basis. Share-Based Compensation We measure the compensation costs of share-based compensation arrangements based on the grant-date fair value and recognize the costs in the financial statements over the period during which employees are required to provide services. Share-based compensation arrangements include options, restricted stock, restricted stock units, performance-based awards, share appreciation rights, and employee share purchase plans. As such, compensation cost is measured on the date of grant at fair value. We amortize such compensation amounts, if any, over the requisite service periods of the award. We use the Black-Scholes-Merton option pricing model, or the Black-Scholes Model, an acceptable model in accordance with ASC 718 to value options. Calculating share-based compensation expense requires the input of highly subjective judgment and assumptions, including forfeiture rates, estimates of expected life of the share-based award, stock price volatility and risk-free interest rates. The assumptions used in calculating the fair value of share-based awards represent our best estimates, but these estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change and we use different assumptions, our share-based compensation expense could be materially different in the future. Equity instruments issued to non-employees are recorded on the basis of the fair value of the instruments, as required by ASC 505, Equity - Based Payments to Non-Employees, or ASC 505. ASC 505 defines the measurement date and recognition period for such instruments. In general, the measurement date is when either (a) a performance commitment, as defined, is reached or (b) the earlier of (i) the non-employee performance is complete or (ii) the instruments are vested. The estimated expense is recognized each period based on the current fair value of the award. As a result, the amount of expense related to awards to non-employees can fluctuate significantly during the period from the date of the grant through the final measurement date. The measured value related to the instruments is recognized over a period based on the facts and circumstances of each particular grant as defined in ASC 505. We generally recognize the compensation expense on a straight-line basis over the employees requisite service period. We estimate the forfeiture rate based on our historical experience of forfeitures. If our actual forfeiture rate is materially different from our estimate, share-based compensation expense could be significantly different from what we have recorded in the current period. Research and Development Expenses Research and development, or R&D, expenses include internal R&D activities, services of external contract research organizations, or CROs, costs of their clinical research sites, manufacturing, scale-up and validation costs, and other activities. Internal R&D activity expenses include laboratory supplies, salaries, benefits, and non-cash share-based compensation expenses. Advance payments to be expensed in future research and development activities are capitalized, and were $364,959 at June 30, 2016, all of which was included in other current assets on the accompanying consolidated balance sheets. Advance payments to be expensed in future research and development activities were $1,138,073 at December 31, 2015, of which $1,009,175 was included in other current assets and $128,898 was included in long term prepaid expense on the accompanying consolidated balance sheets. CRO activity expenses include preclinical laboratory experiments and clinical trial studies. Other activity expenses include regulatory consulting and legal fees and costs. The activities undertaken by our regulatory consultants that were classified as R&D expenses include assisting, consulting with, and advising our in-house staff with respect to various FDA submission processes, clinical trial processes, and scientific writing matters, including preparing protocols and FDA submissions. Legal activities that were classified as R&D expenses related to designing experiments to generate data for patents and to further the formulation development process for our pipeline technologies. Outside legal counsel also provided professional research and advice regarding R&D, patents and regulatory matters. These consulting and legal expenses were direct costs associated with preparing, reviewing, and undertaking work for our clinical trials and investigative drugs. We charge internal R&D activities and other activity expenses 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. We expense nonrefundable advance payments for goods and services that will be used in future R&D activities when the activity has been performed or when the goods have been received rather than when the payment is made. 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 completion stage of a study as provided by CROs. Estimated accrued CRO costs are subject to revisions as such studies progress to completion. We charge revisions expense in the period in which the facts that give rise to the revision become known. Segment Reporting We are managed and operated as one business, which is focused on creating and commercializing products targeted exclusively for women. Our business operations are managed by a single management team that reports to the President of our Company. We do not operate separate lines of business with respect to any of our products and we do not prepare discrete financial information with respect to separate products. All product sales are derived from sales in the United States. Accordingly, we view our business as one reportable operating segment. |
INVENTORY
INVENTORY | 6 Months Ended |
Jun. 30, 2016 | |
Inventory Disclosure [Abstract] | |
INVENTORY | NOTE 4 INVENTORY Inventory consists of the following: June 30, December 31, Finished product $ 855,280 $ 661,167 Raw material 28,376 28,986 TOTAL INVENTORY $ 883,656 $ 690,153 |
OTHER CURRENT ASSETS
OTHER CURRENT ASSETS | 6 Months Ended |
Jun. 30, 2016 | |
Other Assets: | |
OTHER CURRENT ASSETS | NOTE 5 OTHER CURRENT ASSETS Other current assets consist of the following: June 30, December 31, Prepaid insurance $ 408,411 $ 695,421 Prepaid manufacturing costs 986,384 Prepaid consulting 257,796 334,822 Other prepaid costs 267,172 369,812 Prepaid vendor deposits 109,809 159,489 Prepaid research and development costs 107,163 674,353 TOTAL OTHER CURRENT ASSETS $ 2,136,735 $ 2,233,897 |
FIXED ASSETS, NET
FIXED ASSETS, NET | 6 Months Ended |
Jun. 30, 2016 | |
Property, Plant and Equipment [Abstract] | |
FIXED ASSETS, NET | NOTE 6 FIXED ASSETS, NET Fixed assets consist of the following: June 30, December 31, Accounting system in process $ 310,015 $ 149,699 Equipment 226,165 132,150 Furniture and fixtures 80,158 69,454 616,338 351,303 Accumulated depreciation (171,926 ) (152,711 ) TOTAL FIXED ASSETS, NET $ 444,412 $ 198,592 Depreciation expense for the three months ended June 30, 2016 and 2015 was $10,853 and $7,367, respectively, and $19,216 and $14,248 for the six months ended June 30, 2016 and 2015, respectively. |
PREPAID EXPENSE
PREPAID EXPENSE | 6 Months Ended |
Jun. 30, 2016 | |
Prepaid Expense | |
PREPAID EXPENSE | NOTE 7 PREPAID EXPENSE Prepaid expense consists of the following: June 30, December 31, Prepaid manufacturing costs $ 980,985 Prepaid research and development costs 128,898 TOTAL PREPAID EXPENSE $ 1,109,883 |
INTANGIBLE ASSETS, NET
INTANGIBLE ASSETS, NET | 6 Months Ended |
Jun. 30, 2016 | |
Intangible Assets, Net (Excluding Goodwill) [Abstract] | |
INTANGIBLE ASSETS, NET | NOTE 8 INTANGIBLE ASSETS, NET The following table sets forth the gross carrying amount and accumulated amortization of our intangible assets as of June 30, 2016 and December 31, 2015: June 30, 2016 Gross Accumulated Amortization Net Weighted- Average Remaining Amortization Period (yrs.) Amortizing intangible assets: OPERA ® $ 31,951 $ (5,492 ) $ 26,459 13.25 Development costs of corporate website 91,743 (91,743 ) n/a Approved hormone therapy drug candidate patents 954,817 (73,490 ) 881,327 16.5 Hormone therapy drug candidate patents (pending) 903,694 903,694 n/a Non-amortizing intangible assets: Multiple trademarks for vitamins/supplements 172,349 172,349 indefinite TOTAL $ 2,154,554 $ (170,725 ) $ 1,983,829 December 31, 2015 Gross Accumulated Amortization Net Weighted- Average Remaining Amortization Period (yrs.) Amortizing intangible assets: OPERA ® $ 31,951 $ (4,493 ) $ 27,458 13.75 Development costs of corporate website 91,743 (91,743 ) n/a Approved hormone therapy drug candidate patents 705,752 (49,845 ) 655,907 17 Hormone therapy drug candidate patents (pending) 774,165 774,165 n/a Non-amortizing intangible assets: Multiple trademarks for vitamins/supplements 157,721 157,721 indefinite TOTAL $ 1,761,332 $ (146,081 ) $ 1,615,251 We capitalize external costs, consisting primarily of legal costs, related to securing our patents and trademarks. Once a patent is granted, we amortize the approved hormone therapy drug candidate patents using the straight-line method over the estimated useful life of approximately 20 years, which is the life of intellectual property patents. If the patent is not granted, we write-off any capitalized patent costs at that time. Trademarks are perpetual and are not amortized. As of June 30, 2016, the remaining life related to OPERA ® In addition to numerous pending patent applications, as of June 30, 2016, we had 17 issued patents, including: ● 13 utility patents that relate to our combination progesterone and estradiol product candidates, which are owned by us and are U.S. jurisdiction patents with expiration dates in 2032. We have pending patent applications with respect to certain of these patents in Argentina, Australia, Brazil, Canada, Europe, Israel, Japan, Mexico, Russia, South Africa, and South Korea; ● two utility patents that relate to TX-004HR, our applicator-free vaginal estradiol softgel product candidate, which establish an important intellectual property foundation for TX-004HR, which are owned by us and are U.S. jurisdiction patents with expiration dates in 2033 and 2032. We have pending patent applications with respect to certain of these patents in Argentina, Australia, Brazil, Canada, Europe, Israel, Japan, Mexico, Russia, South Africa, and South Korea; ● one utility patent that relates to a pipeline transdermal patch technology, which is owned by us and is a U.S. jurisdiction patent with an expiration date in 2032. We have pending patent applications with respect to this technology in Australia, Brazil, Canada, Europe, Mexico, Japan, and South Africa; and ● one utility patent that relates to our OPERA ® Amortization expense was $13,409 and $6,913 for the three months ended June 30, 2016 and 2015, respectively and $24,643 and $13,604 for the six months ended June 30, 2016 and 2015, respectively. Estimated amortization expense for the next five years is as follows: Year Ending December 31, Estimated Amortization 2016 (6 months) $ 26,819 2017 $ 53,638 2018 $ 53,638 2019 $ 53,638 2020 $ 53,638 |
OTHER CURRENT LIABILITIES
OTHER CURRENT LIABILITIES | 6 Months Ended |
Jun. 30, 2016 | |
Other Liabilities Disclosure [Abstract] | |
OTHER CURRENT LIABILITIES | NOTE 9 OTHER CURRENT LIABILITIES Other current liabilities consist of the following: June 30, December 31, Accrued clinical trial costs $ 3,468,415 $ 3,725,377 Accrued payroll, bonuses and commission costs 1,003,541 2,108,143 Accrued compensated absences 705,326 562,096 Accrued legal and accounting expense 237,265 210,309 Other accrued expenses 511,809 546,264 Allowance for wholesale distributor fees 80,318 32,659 Accrued royalties 36,947 46,851 Allowance for coupons and returns 134,568 224,300 Accrued rent 121,594 83,527 TOTAL OTHER CURRENT LIABILITIES $ 6,299,783 $ 7,539,526 |
NET LOSS PER SHARE
NET LOSS PER SHARE | 6 Months Ended |
Jun. 30, 2016 | |
Earnings Per Share [Abstract] | |
NET LOSS PER SHARE | NOTE 10 NET LOSS PER SHARE We calculate basic and diluted net loss per share allocable to common stockholders using the weighted-average number of shares of common stock, par value $0.001 per share, or Common Stock outstanding during the period, less any shares subject to repurchase or forfeiture. There were no shares of our Common Stock outstanding subject to repurchase or forfeiture for the three and six months ended June 30, 2016 and 2015. Since we are in a net loss position, we have excluded outstanding stock options, all of which are subject to forfeiture, as well as warrants for the purchase of our Common Stock from our calculation of diluted net loss per share. The table below presents potentially dilutive securities that could affect our calculation of diluted net loss per share allocable to common stockholders for the periods presented. Three and Six months ended June 30, 2016 June 30, 2015 Stock options 20,668,657 17,525,200 Warrants 12,060,571 13,032,431 TOTAL 32,729,228 30,557,631 |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 6 Months Ended |
Jun. 30, 2016 | |
Stockholders' Equity Note [Abstract] | |
STOCKHOLDERS' EQUITY | NOTE 11 STOCKHOLDERS EQUITY Preferred Stock At June 30, 2016, 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 June 30, 2016, we had 350,000,000 shares of Common Stock authorized, of which 196,492,195 shares of Common Stock were issued and outstanding. On January 6, 2016, we entered into an underwriting agreement with Goldman Sachs & Co. and Cowen and Company, LLC, as the representatives of the several underwriters, or the Underwriters, relating to an underwritten public offering of 15,151,515 shares of our Common Stock at a public offering price of $8.25 per share. Under the terms of the underwriting agreement, we granted the Underwriters a 30-day option to purchase up to an aggregate of 2,272,727 additional shares of Common Stock, which option was exercised in full. The net proceeds to us from the offering were approximately $134.9 million, after deducting underwriting discounts and commissions and other estimated offering expenses payable by us. The offering closed on January 12, 2016 and we issued 17,424,242 shares of our Common Stock. On July 9, 2015, we entered into an underwriting agreement with Stifel, Nicolaus & Company, Incorporated and Guggenheim Securities, LLC, as the representatives of the several underwriters, or the Stifel Underwriters, relating to an underwritten public offering of 3,846,154 shares of Common Stock at a public offering price of $7.80 per share. Under the terms of the underwriting agreement, we granted the Stifel Underwriters a 30-day option to purchase up to an aggregate of 576,923 additional shares of Common Stock, which option was exercised in full. The net proceeds to us from the offering were approximately $32.2 million, after deducting underwriting discounts and commissions and other estimated offering expenses payable by us. The offering closed on July 15, 2015 and we issued 4,423,077 shares of our Common Stock. On February 10, 2015, we entered into an underwriting agreement, or the Cowen Agreement, with Cowen and Company, LLC, as the representative of the several underwriters, or the Cowen Underwriters, relating to an underwritten public offering of 13,580,246 shares of Common Stock, at a public offering price of $4.05 per share. Under the terms of the Cowen Agreement, we granted the Cowen Underwriters a 30-day option to purchase up to an aggregate of 2,037,036 additional shares of Common Stock, which option was exercised in full. The net proceeds to us from the offering were approximately $59.1 million, after deducting underwriting discounts and commissions and other estimated offering expenses payable by us. The offering closed on February 17, 2015 and we issued 15,617,282 shares of our Common Stock. Exercises During 2016 During the three months ended June 30, 2016, certain individuals exercised stock options to purchase 77,123 shares of Common Stock for $191,592 in cash. During the six months ended June 30, 2016, certain individuals exercised stock options to purchase 417,168 shares of Common Stock for $978,042 in cash. Exercises During 2015 During the three months ended June 30, 2015, certain individuals exercised stock options to purchase 366,617 shares of Common Stock for $484,143 in cash. During the six months ended June 30, 2015, certain individuals exercised stock options to purchase 377,867 shares of Common Stock for $491,351 in cash. Warrants to Purchase Common Stock As of June 30, 2016, we had warrants outstanding to purchase an aggregate of 12,060,571 shares of Common Stock with a weighted-average contractual remaining life of 1.5 years, and exercise prices ranging from $0.24 to $8.20 per share, resulting in a weighted average exercise price of $2.08 per share. The valuation methodology used to determine the fair value of our warrants is the Black-Scholes-Merton valuation model, or 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 term of the warrant. During the three months ended June 30, 2016, we granted warrants to purchase 125,000 shares of Common Stock to outside consultants at an exercise price of $8.20 per share. The fair value for these warrants was determined by using the Black-Scholes Model on the date of the grant using a term of five years; volatility of 74.10%; risk free rate of 1.04%; and dividend yield of 0%. The grant date fair value of the warrants was approximately $4.95 per share. These warrants have an expiration date of April 21, 2021 and vest as follows: warrants to purchase 75,000 shares of Common Stock vested on April 21, 2016 and warrants to purchase 50,000 shares of Common Stock vest ratably over a 24-month period. During the six months ended June 30, 2016, we granted warrants to purchase 245,000 shares of Common Stock to outside consultants at a weighted average exercise price of $7.90 per share. The weighted average grant date fair value of these warrants was $4.78 per share. The fair value for these warrants was determined by using the Black-Scholes Model on the date of the grant using a term of five years; volatility of 74.10%-74.15%; risk free rate of 1.04%-1.28%; and dividend yield of 0%. These warrants vest and have expiration dates as follows: warrants to purchase 75,000 shares of Common Stock vested on April 21, 2016 and have an expiration date of April 21, 2021, warrants to purchase 50,000 shares of Common Stock vest ratably over a 24-month period and have an expiration date of April 21, 2021, and warrants to purchase 120,000 shares of Common Stock vest ratable over a 12-month period and have an expiration date of January 21, 2021. During the three and six months ended June 30, 2015, we granted warrants to purchase 50,000 shares of Common Stock at an exercise price of $6.35 to an outside consultant. We recorded share-based compensation expense related to these warrants totaling $556,125 and $43,741 for the three months ended June 30, 2016 and 2015, respectively, and $683,590 and $43,741 for the six months ended June 30, 2016 and 2015, respectively, in the accompanying consolidated financial statements. In May 2013, we entered into a consulting agreement to develop drug platforms to be used in our hormone replacement drug candidates. As consideration under the agreement, we agreed to issue the consultant a warrant to purchase 850,000 shares of our Common Stock at $2.01 per share that has vested or will vest as follows: 1. Warrants to purchase 283,333 shares were earned on May 11, 2013 upon acceptance of an Investigational New Drug application by FDA for an estradiol-based drug candidate in a softgel vaginal capsule for the treatment of VVA; however, pursuant to the terms of the agreement, the shares did not vest until June 30, 2013; 2. Warrants to purchase 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 five years; a volatility of 45.84%; risk free rate of 1.41%; and a dividend yield of 0%. During the three months ended June 30, 2016 and 2015, we recorded share-based compensation expense of $38,509 and $38,517, respectively, related to these warrants and during the six months ended June 30, 2016 and 2015, we recorded $77,026 and $77,034, respectively, related to these warrants in the accompanying consolidated financial statements. As of June 30, 2016, the fair value of these warrants has been fully amortized; 3. Warrants to purchase 283,334 shares will vest upon the receipt by us of any final FDA approval of a drug candidate which the warrant holder helped us design. It is anticipated that this event will not occur before March 31, 2017. In addition, during both the three months ended June 30, 2016 and 2015, we recorded share-based compensation expense of $64,449 and during both the six months ended June 30, 2016 and 2015, we recorded share-based compensation expense of $128,898 related to warrants issued in 2012 for services in support of our drug development efforts. As of June 30, 2016, unamortized costs associated with warrants issued to the same holder in 2012 and 2013 totaled approximately $258,000. During the three months ended June 30, 2016, certain individuals exercised warrants to purchase 161,372 shares of our Common Stock for $63,000 in cash and during the three months ended June 30, 2015, certain individuals exercised warrants to purchase 20,000 shares of our Common Stock for $7,600 in cash. During the six months ended June 30, 2016, certain individuals exercised warrants to purchase 722,744 shares of our Common Stock for $1,373,000 in cash and during the six months ended June 30, 2015, certain individuals exercised warrants to purchase 945,485 shares of our Common Stock for $366,000 in cash. Options to Purchase Common Stock In 2009, we adopted the 2009 Long Term Incentive Compensation Plan, or the 2009 Plan, to provide financial incentives to employees, directors, advisers, and consultants of our company who are able to contribute towards the creation of or who have created stockholder value by providing them stock options and other stock and cash incentives, or the Awards. The Awards available under the 2009 Plan consist of stock options, stock appreciation rights, restricted stock, restricted stock units, performance stock, performance units, and other stock or cash awards as described in the 2009 Plan. There are 25,000,000 shares authorized for issuance thereunder. During the six months ended June 30, 2016, we granted 373,000 non-qualified stock options under the 2009 Plan. As of June 30, 2016, there were non-qualified stock options to purchase 17,800,183 shares of Common Stock outstanding and stock options to purchase 3,247,352 shares of Common Stock available to be issued under 2009 Plan. In 2012, we adopted the 2012 Stock Incentive Plan, or the 2012 Plan, a non-qualified plan that was amended in August 2013. The 2012 Plan was designed to serve as an incentive for retaining qualified and competent key employees, officers, directors, and certain consultants and advisors of our company. There are 10,000,000 shares of Common Stock authorized for issuance thereunder. As of June 30, 2016, there were non-qualified stock options to purchase 2,868,474 shares of Common Stock outstanding and stock options to purchase 7,050,000 shares of Common Stock available to be issued under 2012 Plan. The valuation methodology used to determine the fair value of 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 for options granted during the six months ended June 30, 2016 and 2015 are set forth in the table below. Six Months Ended June 30, 2016 2015 Risk-free interest rate 1.26-1.70 % 1.47-1.54 % Volatility 70.44-71.22 % 58.77-62.94 % Term (in years) 6.25 5.27-6.25 Dividend yield 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 term. Estimated volatility is a measure of the amount by which the price of our Common Stock is expected to fluctuate each year during the term of an 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 expected term is based on the contractual terms of the stock option using the simplified method. A summary of activity under the 2009 and 2012 Plans and related information follows: Number of Shares Underlying Stock Weighted Average Exercise Weighted Average Remaining Contractual Life in Years Aggregate Intrinsic Balance at December 31, 2015 20,725,325 $ 3.28 6.5 $ 146,864,184 Granted 373,000 $ 7.92 9.7 Exercised (417,168 ) $ 2.34 $ 2,518,090 Expired/Forfeited (12,500 ) $ 6.07 Balance at June 30, 2016 20,668,657 $ 3.38 6.0 $ 107,122,188 Vested and Exercisable at June 30, 2016 16,782,792 $ 2.45 5.4 $ 102,042,737 Unvested at June 30, 2016 3,885,865 $ 7.42 9.0 $ 5,079,451 At June 30, 2016, our outstanding stock options had exercise prices ranging from $0.10 to $8.92 per share. The weighted average grant date fair value per share of options granted was $5.08 and $3.49 during the six months ended June 30, 2016 and 2015, respectively. Share-based compensation expense for options recognized in our results of operations is based on vested awards. Share-based compensation expense related to options for the three months ended June 30, 2016 and 2015 was $4,160,071 and $1,973,675, respectively, and $8,311,330 and $2,702,102, for the six months ended June 30, 2016 and 2015, respectively. We estimate forfeitures at the time of grant and revise the forfeiture rate in subsequent periods if actual forfeitures differ from the estimates. At June 30, 2016, total unrecognized estimated compensation expense related to unvested options granted prior to that date was approximately $13,321,000 which may be adjusted for future changes in forfeitures. This cost is expected to be recognized over a weighted-average period of 1.9 years. No tax benefit was realized due to a continued pattern of operating losses. |
INCOME TAXES
INCOME TAXES | 6 Months Ended |
Jun. 30, 2016 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | NOTE 12 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 2015 as a result of (i) the losses recorded during the six months ended June 30, 2016, (ii) additional losses expected for the remainder of 2015, 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 likely than not that some component or all of the benefits of deferred tax assets will not be realized. As of June 30, 2016, 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. |
RELATED PARTIES
RELATED PARTIES | 6 Months Ended |
Jun. 30, 2016 | |
Related Party Transactions [Abstract] | |
RELATED PARTIES | NOTE 13 RELATED PARTIES In July 2015, J. Martin Carroll, a director of our Company, was appointed to the board of directors of Catalent, Inc. From time to time, we have entered into agreements with Catalent, Inc. in the normal course of business. Agreements with Catalent Inc. have been reviewed by independent directors of our Company or a committee consisting of independent directors of our Company since July 2015. During the three and six months ended June 30, 2016, the amounts billed by Catalent, Inc. were $613,919 and $2,078,776, respectively for manufacturing activities related to our clinical trials. As of June 30, 2016, there were amounts due to Catalent, Inc. of $493,721. |
BUSINESS CONCENTRATIONS
BUSINESS CONCENTRATIONS | 6 Months Ended |
Jun. 30, 2016 | |
Risks and Uncertainties [Abstract] | |
BUSINESS CONCENTRATIONS | NOTE 14 - BUSINESS CONCENTRATIONS We purchase our products from several suppliers with approximately 96% and 98% of our purchases supplied from one vendor for both the six months ended June 30, 2016 and 2015, respectively. We sell our prescription prenatal vitamin 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 major customers accounted for approximately 60% of our recognized revenue for the six months ended June 30, 2016 and revenue generated from major customers accounted for approximately 91% of our recognized revenue for the six months ended June 30, 2015. Customers that generated more than 10% of our sales are designated as customers A, B, and C. During the six months ended June 30, 2016, three customers each generated more than 10% of our total revenues and during the six months ended June 30, 2015, two customers each generated more than 10% of our total revenues. During the six months ended June 30, 2016, customers A, B and C generated approximately $2,237,000, $1,863,000 and $1,540,000, in revenues, respectively. During the six months ended June 30, 2015, customers A and B generated approximately $4,474,000 and $1,832,000, in revenues, respectively. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 6 Months Ended |
Jun. 30, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | NOTE 15 COMMITMENTS AND CONTINGENCIES We lease administrative office space in Boca Raton, Florida pursuant to a non-cancelable operating lease that commenced on July 1, 2013 and originally provided for a 63-month term. On February 18, 2015, we entered into an agreement with the same lessors to lease additional administrative office space in the same location, pursuant to an addendum to such lease. In addition, on April 26, 2016, we entered into agreement with the same lessors to lease additional administrative office space in the same location. This agreement was effective beginning May 1, 2016 and extended the original expiration of the lease term to October 31, 2021. The rental expense related to our lease during the three months ended June 30, 2016 and 2015 was approximately $182,000 and $119,000, respectively. The rental expense related to our lease during the six months ended June 30, 2016 and 2015 was approximately $300,000 and $209,000, respectively. As of June 30, 2016, future minimum rental payments are as follows: Years Ending December 31, 2016 (6 months) $ 304,557 2017 600,236 2018 673,236 2019 810,234 2020 824,268 Thereafter 698,421 Total minimum lease payments $ 3,910,952 |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 6 Months Ended |
Jun. 30, 2016 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 16 SUBSEQUENT EVENTS We submitted the New Drug Application, or NDA, for TX-004HR with the U.S. Food and Drug Administration, or FDA, on July 7, 2016. The NDA submission was supported by the complete TX-004HR clinical program, including positive results of the recently completed phase 3 R ejoice |
SUMMARY OF SIGNIFICANT ACCOUN22
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 6 Months Ended |
Jun. 30, 2016 | |
Accounting Policies [Abstract] | |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Our financial instruments consist primarily of accounts receivable, accounts payable and accrued expenses. 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. Level 1 unadjusted quoted prices in active markets for identical assets or liabilities; Level 2 quoted 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 3 unobservable inputs for the asset or liability. At June 30, 2016 and 2015, we had no assets or liabilities that were valued at fair value on a recurring basis. The fair value of indefinite-lived assets or long-lived assets is measured on a non-recurring basis using significant unobservable inputs (Level 3) in connection with our impairment test. There was no impairment of intangible assets or long-lived assets during the three and six months ended June 30, 2016 and 2015. |
Revenue Recognition | Revenue Recognition We recognize revenue on arrangements in accordance with ASC 605, Revenue Recognition. We recognize revenue only when the price is fixed or determinable, persuasive evidence of an arrangement exists, the service is performed, and collectability is reasonably assured. Our OTC and prescription prenatal vitamin products are generally variations of the same product with slight modifications in formulation and marketing. The primary difference between our OTC and prescription prenatal vitamin products is the source of payment. Purchasers of our OTC prenatal vitamin products pay for the product directly while purchasers of our prescription prenatal vitamin products pay for the product primarily via third-party payers. Both OTC and prescription prenatal vitamin products share the same marketing support team utilizing similar marketing techniques. The revenue that is generated by us from major customers is all generated from sales of our prescription prenatal vitamin products which is disclosed in Note 14. There are no major customers for our OTC prenatal vitamin or other products. Over-the-Counter Products We generate OTC revenue from product sales primarily to retail consumers. We recognize revenue from product sales upon shipment, when the rights of ownership and risk of loss have passed to the consumer. We include outbound shipping and handling fees in revenues, net, and bill them upon shipment. We include shipping expenses in cost of goods sold. A majority of our OTC customers pay for our products with credit cards, and we usually receive the cash settlement in two to three banking days. Credit card sales minimize accounts receivable balances relative to OTC sales. We provide an unconditional 30-day money-back return policy under which we accept product returns from our retail and eCommerce OTC customers. We recognize revenue from OTC sales, net of estimated returns, sales discounts, and eCommerce fees. Prescription Products We sell our name brand and generic prescription products primarily through drug wholesalers and retail pharmacies. We recognize revenue from prescription product sales, net of sales discounts, chargebacks, and customer rebates. We accept returns of unsalable prescription products from customers within a return period of six months prior to and up to 12 months following product expiration. Our prescription products currently have a shelf life of 24 months from the date of manufacture. We estimate returns based on historical return rates and recorded actual product returns against this reserve as received. We offer various rebate programs in an effort to maintain a competitive position in the marketplace and to promote sales and customer loyalty. The consumer rebate program is designed to enable the end user to submit a coupon to us. If the coupon qualifies, we send a rebate check to the end user. We estimate the allowance for consumer rebates that we have offered based on our experience and industry averages, which is reviewed, and adjusted if necessary, on a quarterly basis. |
Share-Based Compensation | Share-Based Compensation We measure the compensation costs of share-based compensation arrangements based on the grant-date fair value and recognize the costs in the financial statements over the period during which employees are required to provide services. Share-based compensation arrangements include options, restricted stock, restricted stock units, performance-based awards, share appreciation rights, and employee share purchase plans. As such, compensation cost is measured on the date of grant at fair value. We amortize such compensation amounts, if any, over the requisite service periods of the award. We use the Black-Scholes-Merton option pricing model, or the Black-Scholes Model, an acceptable model in accordance with ASC 718 to value options. Calculating share-based compensation expense requires the input of highly subjective judgment and assumptions, including forfeiture rates, estimates of expected life of the share-based award, stock price volatility and risk-free interest rates. The assumptions used in calculating the fair value of share-based awards represent our best estimates, but these estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change and we use different assumptions, our share-based compensation expense could be materially different in the future. Equity instruments issued to non-employees are recorded on the basis of the fair value of the instruments, as required by ASC 505, Equity - Based Payments to Non-Employees, or ASC 505. ASC 505 defines the measurement date and recognition period for such instruments. In general, the measurement date is when either (a) a performance commitment, as defined, is reached or (b) the earlier of (i) the non-employee performance is complete or (ii) the instruments are vested. The estimated expense is recognized each period based on the current fair value of the award. As a result, the amount of expense related to awards to non-employees can fluctuate significantly during the period from the date of the grant through the final measurement date. The measured value related to the instruments is recognized over a period based on the facts and circumstances of each particular grant as defined in ASC 505. We generally recognize the compensation expense on a straight-line basis over the employees requisite service period. We estimate the forfeiture rate based on our historical experience of forfeitures. If our actual forfeiture rate is materially different from our estimate, share-based compensation expense could be significantly different from what we have recorded in the current period. |
Research and Development Expenses | Research and Development Expenses Research and development, or R&D, expenses include internal R&D activities, services of external contract research organizations, or CROs, costs of their clinical research sites, manufacturing, scale-up and validation costs, and other activities. Internal R&D activity expenses include laboratory supplies, salaries, benefits, and non-cash share-based compensation expenses. Advance payments to be expensed in future research and development activities are capitalized, and were $364,959 at June 30, 2016, all of which was included in other current assets on the accompanying consolidated balance sheets. Advance payments to be expensed in future research and development activities were $1,138,073 at December 31, 2015, of which $1,009,175 was included in other current assets and $128,898 was included in long term prepaid expense on the accompanying consolidated balance sheets. CRO activity expenses include preclinical laboratory experiments and clinical trial studies. Other activity expenses include regulatory consulting and legal fees and costs. The activities undertaken by our regulatory consultants that were classified as R&D expenses include assisting, consulting with, and advising our in-house staff with respect to various FDA submission processes, clinical trial processes, and scientific writing matters, including preparing protocols and FDA submissions. Legal activities that were classified as R&D expenses related to designing experiments to generate data for patents and to further the formulation development process for our pipeline technologies. Outside legal counsel also provided professional research and advice regarding R&D, patents and regulatory matters. These consulting and legal expenses were direct costs associated with preparing, reviewing, and undertaking work for our clinical trials and investigative drugs. We charge internal R&D activities and other activity expenses 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. We expense nonrefundable advance payments for goods and services that will be used in future R&D activities when the activity has been performed or when the goods have been received rather than when the payment is made. 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 completion stage of a study as provided by CROs. Estimated accrued CRO costs are subject to revisions as such studies progress to completion. We charge revisions expense in the period in which the facts that give rise to the revision become known. |
Segment Reporting | Segment Reporting We are managed and operated as one business, which is focused on creating and commercializing products targeted exclusively for women. Our business operations are managed by a single management team that reports to the President of our Company. We do not operate separate lines of business with respect to any of our products and we do not prepare discrete financial information with respect to separate products. All product sales are derived from sales in the United States. Accordingly, we view our business as one reportable operating segment. |
INVENTORY (Tables)
INVENTORY (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Inventory Disclosure [Abstract] | |
Schedule of inventory | Inventory consists of the following: June 30, December 31, Finished product $ 855,280 $ 661,167 Raw material 28,376 28,986 TOTAL INVENTORY $ 883,656 $ 690,153 |
OTHER CURRENT ASSETS (Tables)
OTHER CURRENT ASSETS (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Other Assets: | |
Schedule of other current assets | Other current assets consist of the following: June 30, December 31, Prepaid insurance $ 408,411 $ 695,421 Prepaid manufacturing costs 986,384 Prepaid consulting 257,796 334,822 Other prepaid costs 267,172 369,812 Prepaid vendor deposits 109,809 159,489 Prepaid research and development costs 107,163 674,353 TOTAL OTHER CURRENT ASSETS $ 2,136,735 $ 2,233,897 |
FIXED ASSETS, NET (Tables)
FIXED ASSETS, NET (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Property, Plant and Equipment [Abstract] | |
Schedule of fixed assets | Fixed assets consist of the following: June 30, December 31, Accounting system in process $ 310,015 $ 149,699 Equipment 226,165 132,150 Furniture and fixtures 80,158 69,454 616,338 351,303 Accumulated depreciation (171,926 ) (152,711 ) TOTAL FIXED ASSETS, NET $ 444,412 $ 198,592 |
PREPAID EXPENSE (Tables)
PREPAID EXPENSE (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Prepaid Expense | |
Schedule of prepaid expense | Prepaid expense consists of the following: June 30, December 31, Prepaid manufacturing costs $ 980,985 Prepaid research and development costs 128,898 TOTAL PREPAID EXPENSE $ 1,109,883 |
INTANGIBLE ASSETS, NET (Tables)
INTANGIBLE ASSETS, NET (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Intangible Assets, Net (Excluding Goodwill) [Abstract] | |
Schedule of intangible assets | The following table sets forth the gross carrying amount and accumulated amortization of our intangible assets as of June 30, 2016 and December 31, 2015: June 30, 2016 Gross Accumulated Amortization Net Weighted- Average Remaining Amortization Period (yrs.) Amortizing intangible assets: OPERA ® $ 31,951 $ (5,492 ) $ 26,459 13.25 Development costs of corporate website 91,743 (91,743 ) n/a Approved hormone therapy drug candidate patents 954,817 (73,490 ) 881,327 16.5 Hormone therapy drug candidate patents (pending) 903,694 903,694 n/a Non-amortizing intangible assets: Multiple trademarks for vitamins/supplements 172,349 172,349 indefinite TOTAL $ 2,154,554 $ (170,725 ) $ 1,983,829 December 31, 2015 Gross Accumulated Amortization Net Weighted- Average Remaining Amortization Period (yrs.) Amortizing intangible assets: OPERA ® $ 31,951 $ (4,493 ) $ 27,458 13.75 Development costs of corporate website 91,743 (91,743 ) n/a Approved hormone therapy drug candidate patents 705,752 (49,845 ) 655,907 17 Hormone therapy drug candidate patents (pending) 774,165 774,165 n/a Non-amortizing intangible assets: Multiple trademarks for vitamins/supplements 157,721 157,721 indefinite TOTAL $ 1,761,332 $ (146,081 ) $ 1,615,251 |
Schedule of estimated amortization expense | Estimated amortization expense for the next five years is as follows: Year Ending December 31, Estimated Amortization 2016 (6 months) $ 26,819 2017 $ 53,638 2018 $ 53,638 2019 $ 53,638 2020 $ 53,638 |
OTHER CURRENT LIABILITIES (Tabl
OTHER CURRENT LIABILITIES (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Other Liabilities Disclosure [Abstract] | |
Schedule of other current liabilities | Other current liabilities consist of the following: June 30, December 31, Accrued clinical trial costs $ 3,468,415 $ 3,725,377 Accrued payroll, bonuses and commission costs 1,003,541 2,108,143 Accrued compensated absences 705,326 562,096 Accrued legal and accounting expense 237,265 210,309 Other accrued expenses 511,809 546,264 Allowance for wholesale distributor fees 80,318 32,659 Accrued royalties 36,947 46,851 Allowance for coupons and returns 134,568 224,300 Accrued rent 121,594 83,527 TOTAL OTHER CURRENT LIABILITIES $ 6,299,783 $ 7,539,526 |
NET LOSS PER SHARE (Tables)
NET LOSS PER SHARE (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Earnings Per Share [Abstract] | |
Schedule of potentially dilutive securities | The table below presents potentially dilutive securities that could affect our calculation of diluted net loss per share allocable to common stockholders for the periods presented. Three and Six months ended June 30, 2016 June 30, 2015 Stock options 20,668,657 17,525,200 Warrants 12,060,571 13,032,431 TOTAL 32,729,228 30,557,631 |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Stockholders' Equity Note [Abstract] | |
Schedule of assumptions used in the Black-Scholes Model of stock options | The assumptions used in the Black-Scholes Model for options granted during the six months ended June 30, 2016 and 2015 are set forth in the table below. Six Months Ended June 30, 2016 2015 Risk-free interest rate 1.26-1.70 % 1.47-1.54 % Volatility 70.44-71.22 % 58.77-62.94 % Term (in years) 6.25 5.27-6.25 Dividend yield 0.00 % 0.00 % |
Schedule of plan activity | A summary of activity under the 2009 and 2012 Plans and related information follows: Number of Shares Underlying Stock Weighted Average Exercise Weighted Average Remaining Contractual Life in Years Aggregate Intrinsic Balance at December 31, 2015 20,725,325 $ 3.28 6.5 $ 146,864,184 Granted 373,000 $ 7.92 9.7 Exercised (417,168 ) $ 2.34 $ 2,518,090 Expired/Forfeited (12,500 ) $ 6.07 Balance at June 30, 2016 20,668,657 $ 3.38 6.0 $ 107,122,188 Vested and Exercisable at June 30, 2016 16,782,792 $ 2.45 5.4 $ 102,042,737 Unvested at June 30, 2016 3,885,865 $ 7.42 9.0 $ 5,079,451 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of future minimum rental payments | As of June 30, 2016, future minimum rental payments are as follows: Years Ending December 31, 2016 (6 months) $ 304,557 2017 600,236 2018 673,236 2019 810,234 2020 824,268 Thereafter 698,421 Total minimum lease payments $ 3,910,952 |
SUMMARY OF SIGNIFICANT ACCOUN32
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) | 6 Months Ended | |
Jun. 30, 2016USD ($)N | Dec. 31, 2015USD ($) | |
Shelf life of prescription products | 24 months | |
Number of operating segment | N | 1 | |
Related to Research and Development Activities [Member] | ||
Advance payments - total | $ 364,959 | $ 1,138,073 |
Advance payments - other assets current | 1,009,175 | |
Advance payments - long term prepaid expense | $ 128,898 | |
Minimum [Member] | ||
Return period of unsalable prescription products | 6 months | |
Maximum [Member] | ||
Return period of unsalable prescription products | 12 months |
INVENTORY (Details)
INVENTORY (Details) - USD ($) | Jun. 30, 2016 | Dec. 31, 2015 |
Inventory | ||
Finished product | $ 855,280 | $ 661,167 |
Raw material | 28,376 | 28,986 |
TOTAL INVENTORY | $ 883,656 | $ 690,153 |
OTHER CURRENT ASSETS (Details)
OTHER CURRENT ASSETS (Details) - USD ($) | Jun. 30, 2016 | Dec. 31, 2015 |
Other Current Assets | ||
Prepaid insurance | $ 408,411 | $ 695,421 |
Prepaid manufacturing costs | 986,384 | |
Prepaid consulting | 257,796 | 334,822 |
Other prepaid costs | 267,172 | 369,812 |
Prepaid vendor deposits | 109,809 | 159,489 |
Prepaid research and development costs | 107,163 | 674,353 |
TOTAL OTHER CURRENT ASSETS | $ 2,136,735 | $ 2,233,897 |
FIXED ASSETS, NET (Details Narr
FIXED ASSETS, NET (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Property, Plant and Equipment [Abstract] | ||||
Depreciation expense | $ 10,853 | $ 7,367 | $ 19,216 | $ 14,248 |
FIXED ASSETS, NET (Details)
FIXED ASSETS, NET (Details) - USD ($) | Jun. 30, 2016 | Dec. 31, 2015 |
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | $ 616,338 | $ 351,303 |
Accumulated depreciation | (171,926) | (152,711) |
TOTAL FIXED ASSETS, NET | 444,412 | 198,592 |
Accounting System in Process [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | 310,015 | 149,699 |
Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | 226,165 | 132,150 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | $ 80,158 | $ 69,454 |
PREPAID EXPENSE (Details)
PREPAID EXPENSE (Details) | Dec. 31, 2015USD ($) |
Prepaid Expense | |
Prepaid manufacturing costs | $ 980,985 |
Prepaid research and development costs | 128,898 |
TOTAL PREPAID EXPENSE | $ 1,109,883 |
INTANGIBLE ASSETS, NET (Details
INTANGIBLE ASSETS, NET (Details Narrative) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016USD ($)N | Jun. 30, 2015USD ($) | Jun. 30, 2016USD ($)N | Jun. 30, 2015USD ($) | |
Finite-Lived Intangible Assets [Line Items] | ||||
Amortization expense | $ | $ 13,409 | $ 6,913 | $ 24,643 | $ 13,604 |
Number of issued patents | 17 | 17 | ||
Hormone therapy drug candidate patents - (pending) [Member] | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Useful Life | 16 years 6 months | |||
OPERA software patent [Member] | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Useful Life | 13 years | |||
Number of issued patents | 1 | 1 | ||
Approved Hormone Therapy Drug Candidate Patents [Member] | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Useful Life | 20 years | |||
Utility Patent Progesterone and Estradiol Products [Member] | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Number of issued patents | 13 | 13 | ||
Utility Patent TX-004HR [Member] | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Number of issued patents | 2 | 2 | ||
Utility Patent Pipeline Transdermal Patch Technology [Member] | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Number of issued patents | 1 | 1 |
INTANGIBLE ASSETS, NET (Detai39
INTANGIBLE ASSETS, NET (Details) - USD ($) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2016 | Dec. 31, 2015 | |
Finite-Lived Intangible Assets | ||
Accumulated Amortization | $ (170,725) | $ (146,081) |
Indefinite-Lived Intangible Assets | ||
Gross Carrying Amount | 2,154,554 | 1,761,332 |
Net Amount | 1,983,829 | 1,615,251 |
Hormone therapy drug candidate patents - (pending) [Member] | ||
Finite-Lived Intangible Assets | ||
Gross Carrying Amount | 903,694 | 774,165 |
Net Amount | 903,694 | 774,165 |
Multiple trademarks for vitamins/supplements [Member] | ||
Indefinite-Lived Intangible Assets | ||
Gross Carrying Amount | 172,349 | 157,721 |
Net Amount | 172,349 | 157,721 |
OPERA software patent [Member] | ||
Finite-Lived Intangible Assets | ||
Gross Carrying Amount | 31,951 | 31,951 |
Accumulated Amortization | (5,492) | (4,493) |
Net Amount | $ 26,459 | $ 27,458 |
Weighted average remaining amortization period | 13 years 3 months | 13 years 9 months |
Development costs of corporate website [Member] | ||
Finite-Lived Intangible Assets | ||
Gross Carrying Amount | $ 91,743 | $ 91,743 |
Accumulated Amortization | (91,743) | (91,743) |
Net Amount | ||
Approved Hormone Therapy Drug Candidate Patents [Member] | ||
Finite-Lived Intangible Assets | ||
Gross Carrying Amount | 954,817 | 705,752 |
Accumulated Amortization | (73,490) | (49,845) |
Net Amount | $ 881,327 | $ 655,907 |
Weighted average remaining amortization period | 16 years 6 months | 17 years |
INTANGIBLE ASSETS, NET (Detai40
INTANGIBLE ASSETS, NET (Details 1) | Jun. 30, 2016USD ($) |
Estimated amortization expense for the year: | |
2016 (6 months) | $ 26,819 |
2,017 | 53,638 |
2,018 | 53,638 |
2,019 | 53,638 |
2,020 | $ 53,638 |
OTHER CURRENT LIABILITIES (Deta
OTHER CURRENT LIABILITIES (Details) - USD ($) | Jun. 30, 2016 | Dec. 31, 2015 |
Other Liabilities Disclosure [Abstract] | ||
Accrued clinical trial costs | $ 3,468,415 | $ 3,725,377 |
Accrued payroll, bonuses and commission costs | 1,003,541 | 2,108,143 |
Accrued compensated absences | 705,326 | 562,096 |
Accrued legal and accounting expense | 237,265 | 210,309 |
Other accrued expenses | 511,809 | 546,264 |
Allowance for wholesale distributor fees | 80,318 | 32,659 |
Accrued royalties | 36,947 | 46,851 |
Allowance for coupons and returns | 134,568 | 224,300 |
Accrued rent | 121,594 | 83,527 |
TOTAL OTHER CURRENT LIABILITIES | $ 6,299,783 | $ 7,539,526 |
NET LOSS PER SHARE (Details)
NET LOSS PER SHARE (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive shares excluded from earnings per share calculation | 32,729,228 | 30,557,631 | 32,729,228 | 30,557,631 |
Warrants [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive shares excluded from earnings per share calculation | 12,060,571 | 13,032,431 | 12,060,571 | 13,032,431 |
Stock Options [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive shares excluded from earnings per share calculation | 20,668,657 | 17,525,200 | 20,668,657 | 17,525,200 |
STOCKHOLDERS' EQUITY (Details N
STOCKHOLDERS' EQUITY (Details Narrative) - USD ($) | Jan. 12, 2016 | Jan. 06, 2016 | Jul. 15, 2015 | Jul. 09, 2015 | Feb. 17, 2015 | Feb. 10, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2015 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | ||||||||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | 10,000,000 | ||||||||
Preferred stock, shares issued | 0 | 0 | 0 | ||||||||
Preferred stock, shares outstanding | 0 | 0 | 0 | ||||||||
Common stock, shares authorized | 350,000,000 | 350,000,000 | 350,000,000 | ||||||||
Common stock, shares issued | 196,492,195 | 196,492,195 | 177,928,041 | ||||||||
Common stock, shares outstanding | 196,492,195 | 196,492,195 | 177,928,041 | ||||||||
2009 Long-term Incentive Plan [Member] | |||||||||||
Weighted average grant date fair value | $ 5.08 | $ 5.08 | |||||||||
Number of shares authorized for issuance | 25,000,000 | 25,000,000 | |||||||||
Options outstanding, ending | 17,800,183 | 17,800,183 | |||||||||
Number of shares available for issuance | 3,247,352 | 3,247,352 | |||||||||
2012 Stock Incentive Plan [Member] | |||||||||||
Number of shares authorized for issuance | 10,000,000 | 10,000,000 | |||||||||
Options outstanding, ending | 2,868,474 | 2,868,474 | |||||||||
Number of shares available for issuance | 7,050,000 | 7,050,000 | |||||||||
Stock Options [Member] | |||||||||||
Number of common stock issued during period for stock options exercised | 417,168 | ||||||||||
Exercise price of options | $ 3.38 | $ 3.38 | $ 3.28 | ||||||||
Weighted average grant date fair value | $ 3.49 | $ 3.49 | |||||||||
Exercise price - lower | .10 | ||||||||||
Exercise price - upper | $ 8.92 | ||||||||||
Sharebased compensation - stock options | $ 4,160,071 | $ 1,973,675 | $ 8,311,330 | $ 2,702,102 | |||||||
Unrecognized estimated compensation expense | $ 13,321,000 | $ 13,321,000 | |||||||||
Recognized period for recognition - stock option compensation | 1 year 10 months 24 days | ||||||||||
Options outstanding, ending | 20,668,657 | 20,668,657 | 20,725,325 | ||||||||
Options exercised [Member] | |||||||||||
Number of common stock issued during period for stock options exercised | 77,123 | 366,617 | 417,168 | 377,867 | |||||||
Value of common stock issued during period for stock options exercised | $ 191,592 | $ 484,143 | $ 978,042 | $ 491,351 | |||||||
Underwriting Agreement - Goldman And Cowen [Member] | |||||||||||
Number of shares issued during the period | 17,242,242 | 15,151,515 | |||||||||
Share price (in dollars per share) | $ 8.25 | ||||||||||
Common stock issued during the period | $ 134,900,000 | ||||||||||
Additional common stock issued under offering | 2,272,727 | ||||||||||
Number of days of the option to purchase shares | 30 days | ||||||||||
Stifel Underwriters [Member] | |||||||||||
Number of shares issued during the period | 4,423,077 | 3,846,154 | |||||||||
Share price (in dollars per share) | $ 7.80 | ||||||||||
Common stock issued during the period | $ 32,200,000 | ||||||||||
Additional common stock issued under offering | 576,923 | ||||||||||
Number of days of the option to purchase shares | 30 days | ||||||||||
Cowen and Company, LLC (Underwriters) [Member] | |||||||||||
Number of shares issued during the period | 15,617,282 | 13,580,246 | |||||||||
Share price (in dollars per share) | $ 4.05 | ||||||||||
Common stock issued during the period | $ 59,100,000 | ||||||||||
Additional common stock issued under offering | 2,037,036 | ||||||||||
Number of days of the option to purchase shares | 30 days |
STOCKHOLDERS' EQUITY (Details44
STOCKHOLDERS' EQUITY (Details Narrative 1) - USD ($) | May 11, 2013 | Jun. 30, 2013 | Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 |
Warrants: | |||||||
Warrants outstanding | $ 12,060,571 | $ 12,060,571 | $ 12,060,571 | ||||
Weighted-average contractual remaining life | 1 year 6 months | ||||||
Exercise price of warrants (in dollars per share) | $ 2.08 | $ 2.08 | $ 2.08 | ||||
Share based compensation expense | $ 9,200,844 | $ 2,968,811 | |||||
Outside Consultant Warrants [Member] | |||||||
Warrants: | |||||||
Exercise price of warrants (in dollars per share) | $ 8.20 | $ 8.20 | 8.20 | ||||
Warrants granted (shares) | 125,000 | ||||||
Share based compensation expense | $ 556,125 | $ 43,741 | $ 683,590 | $ 43,741 | |||
Grant date fair value (in dollars per share) | $ 4.95 | ||||||
Expiration date of warrants | Apr. 21, 2021 | ||||||
Expected term | 5 years | ||||||
Volatility rate | 74.10% | ||||||
Risk free rate | 1.04% | ||||||
Dividend yield | 0.00% | ||||||
Outside Consultant Warrants [Member] | Tranche One [Member] | |||||||
Warrants: | |||||||
Warrants granted (shares) | 75,000 | ||||||
Expiration date of warrants | Apr. 21, 2021 | ||||||
Vesting date of warrants | Apr. 21, 2016 | ||||||
Vesting date of warrants | 24 months | ||||||
Outside Consultant Warrants [Member] | Tranche Two [Member] | |||||||
Warrants: | |||||||
Warrants granted (shares) | 50,000 | ||||||
Expiration date of warrants | Apr. 21, 2021 | ||||||
Vesting date of warrants | 24 months | ||||||
Outside Consultant Warrants #2 [Member] | |||||||
Warrants: | |||||||
Warrants granted (shares) | 245,000 | ||||||
Grant date fair value (in dollars per share) | $ 4.78 | ||||||
Expected term | 5 years | ||||||
Dividend yield | 0.00% | ||||||
Weighted average exercise price of warrants | $ 7.90 | $ 7.90 | $ 7.90 | ||||
Outside Consultant Warrants #2 [Member] | Tranche One [Member] | |||||||
Warrants: | |||||||
Warrants granted (shares) | 75,000 | ||||||
Expiration date of warrants | Apr. 21, 2021 | ||||||
Vesting date of warrants | Apr. 21, 2016 | ||||||
Outside Consultant Warrants #2 [Member] | Tranche Two [Member] | |||||||
Warrants: | |||||||
Warrants granted (shares) | 50,000 | ||||||
Expiration date of warrants | Apr. 21, 2021 | ||||||
Vesting date of warrants | 24 months | ||||||
Outside Consultant Warrants #2 [Member] | Tranche Three [Member] | |||||||
Warrants: | |||||||
Warrants granted (shares) | 120,000 | ||||||
Expiration date of warrants | Jan. 21, 2021 | ||||||
Vesting date of warrants | 12 months | ||||||
Outside Consultant Warrants #3 [Member] | |||||||
Warrants: | |||||||
Exercise price of warrants (in dollars per share) | $ 6.35 | $ 6.35 | |||||
Warrants granted (shares) | 50,000 | 50,000 | |||||
Consultant Agreement - Warrants [Member] | |||||||
Warrants: | |||||||
Exercise price of warrants (in dollars per share) | $ 2.01 | ||||||
Warrants granted (shares) | 283,333 | 283,333 | 850,000 | ||||
Fair value of grant | $ 462,196 | ||||||
Share based compensation expense | $ 38,509 | $ 38,517 | $ 77,026 | $ 77,034 | |||
Expected term | 5 years | ||||||
Volatility rate | 45.84% | ||||||
Risk free rate | 1.41% | ||||||
Dividend yield | 0.00% | ||||||
Expected to vested warrants upon FDA approval (in shares) | 283,334 | 283,334 | 283,334 | ||||
Unamortized noncash compensation associated with warrants | $ 258,000 | $ 258,000 | $ 258,000 | ||||
Warrants [Member] | |||||||
Warrants: | |||||||
Share based compensation expense | $ 64,449 | $ 64,449 | $ 128,898 | $ 128,898 | |||
Stock issued for excercised warrants, shares | 161,372 | 20,000 | 722,744 | 945,485 | |||
Stock issued for excercised warrants, value | $ 63,000 | $ 7,600 | $ 1,373,000 | $ 366,000 | |||
Minimum [Member] | Outside Consultant Warrants #2 [Member] | |||||||
Warrants: | |||||||
Volatility rate | 74.10% | ||||||
Risk free rate | 1.04% | ||||||
Maximum [Member] | Outside Consultant Warrants #2 [Member] | |||||||
Warrants: | |||||||
Volatility rate | 74.15% | ||||||
Risk free rate | 1.28% | ||||||
Warrants [Member] | Minimum [Member] | |||||||
Warrants: | |||||||
Exercise price of warrants (in dollars per share) | $ 0.24 | $ 0.24 | $ 0.24 | ||||
Warrants [Member] | Maximum [Member] | |||||||
Warrants: | |||||||
Exercise price of warrants (in dollars per share) | $ 8.20 | $ 8.20 | $ 8.20 |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) - Stock Options [Member] | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Term | 6 years 3 months | |
Dividend yield | 0.00% | 0.00% |
Minimum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 1.26% | 1.47% |
Volatility | 70.44% | 58.77% |
Term | 5 years 3 months 7 days | |
Maximum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 1.70% | 1.54% |
Volatility | 71.22% | 62.94% |
Term | 6 years 3 months |
STOCKHOLDERS' EQUITY (Details 1
STOCKHOLDERS' EQUITY (Details 1) - Stock Options [Member] - USD ($) | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | ||
Options outstanding, beginning | 20,725,325 | |
Options Granted | 373,000 | |
Options Exercised | (417,168) | |
Options Expired/Forfeited | (12,500) | |
Options outstanding, ending | 20,668,657 | |
Vested and exercisable | 16,782,792 | |
Unvested | 3,885,865 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Roll Forward] | ||
Options outstanding, beginning | $ 3.28 | |
Granted | 7.92 | |
Exercised | 2.34 | |
Expired/Forfeited | 6.07 | |
Options outstanding, ending | 3.38 | |
Vested and exercisable | 2.45 | |
Unvested | $ 7.42 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Weighted Average Remaining Contractual Life [Roll Forward] | ||
Options outstanding | 6 years | 6 years 6 months |
Granted | 9 years 8 months 12 days | |
Vested and exercisable | 5 years 4 months 24 days | |
Unvested | 9 years | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Additional Disclosures [Roll Forward] | ||
Options outstanding, beginning | $ 146,864,184 | |
Options exercised | 2,518,090 | |
Options outstanding, ending | 107,122,188 | |
Vested and exercisable | 102,042,737 | |
Unvested | $ 5,079,451 |
RELATED PARTIES (Details Narrat
RELATED PARTIES (Details Narrative) - Catalent Inc.[Member] | 3 Months Ended | 6 Months Ended |
Jun. 30, 2016USD ($) | Jun. 30, 2016USD ($) | |
Related Party Transaction [Line Items] | ||
Payable - related party | $ 493,721 | $ 493,721 |
Manufacturing activities billed from related party | $ 613,919 | $ 2,078,776 |
BUSINESS CONCENTRATIONS (Detail
BUSINESS CONCENTRATIONS (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Concentration Risk [Line Items] | ||||
Revenues | $ 4,403,247 | $ 4,847,934 | $ 9,333,338 | $ 9,322,983 |
Supplier Concentration Risk [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration Risk | 96.00% | 98.00% | ||
Customer Concentration Risk [Member] | Sales Revenue [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration Risk | 60.00% | 91.00% | ||
Customer Concentration Risk [Member] | Sales Revenue [Member] | Three Customers [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration Risk | 10.00% | |||
Customer Concentration Risk [Member] | Sales Revenue [Member] | Two Customers [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration Risk | 10.00% | |||
Customer A [Member] | Sales Revenue [Member] | ||||
Concentration Risk [Line Items] | ||||
Revenues | $ 2,237,000 | $ 4,474,000 | ||
Customer B [Member] | Sales Revenue [Member] | ||||
Concentration Risk [Line Items] | ||||
Revenues | 1,863,000 | $ 1,832,000 | ||
Customer C [Member] | Sales Revenue [Member] | ||||
Concentration Risk [Line Items] | ||||
Revenues | $ 1,540,000 |
COMMITMENTS AND CONTINGENCIES49
COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | ||||
Non-cancelable operating lease term | 63 months | |||
Rental expense | $ 182,000 | $ 119,000 | $ 300,000 | $ 209,000 |
COMMITMENTS AND CONTINGENCIES50
COMMITMENTS AND CONTINGENCIES (Details) | Jun. 30, 2016USD ($) |
Future minimum rental payments, year ending December 31, | |
2016 (6 months) | $ 304,557 |
2,017 | 600,236 |
2,018 | 673,236 |
2,019 | 810,234 |
2,020 | 824,268 |
Thereafter | 698,421 |
Total minimum lease payments | $ 3,910,952 |