TherapeuticsMD (TXMD) 10-Q 8 Nov 19 2019 Q3 Quarterly report Financial data

Cover

Cover - shares	9 Months Ended
	Sep. 30, 2019	Nov. 04, 2019
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Sep. 30, 2019
Document Fiscal Period Focus	Q3
Document Fiscal Year Focus	2019
Current Fiscal Year End Date	--12-31
Entity File Number	001-00100
Entity Registrant Name	THERAPEUTICSMD, INC.
Entity Central Index Key	0000025743
Entity Tax Identification Number	87-0233535
Entity Incorporation, State or Country Code	NV
Entity Address, Address Line One	951 Yamato Road
Entity Address, Address Line Two	Suite 220
Entity Address, City or Town	Boca Raton
Entity Address, State or Province	FL
Entity Address, Postal Zip Code	33431
City Area Code	561
Local Phone Number	961-1900
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	TXMD
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Large Accelerated Filer
Entity Small Business	false
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		271,177,076

CONSOLIDATED BALANCE SHEETS

CONSOLIDATED BALANCE SHEETS - USD ($)	Sep. 30, 2019	Dec. 31, 2018
Current Assets:
Cash	$ 155,330,050	$ 161,613,077
Accounts receivable, net of allowance for doubtful accounts of $691,699 and $596,602, respectively	15,323,614	11,063,821
Inventory	10,532,844	3,267,670
Other current assets	10,578,260	10,834,693
Total current assets	191,764,768	186,779,261
Fixed assets, net	2,338,346	472,683
Other Assets:
License rights, net	39,984,002	20,000,000
Intangible assets, net	4,942,151	4,092,679
Right of use asset	10,459,635
Other assets	473,009	639,301
Total other assets	55,858,797	24,731,980
Total assets	249,961,911	211,983,924
Current Liabilities:
Accounts payable	24,133,506	22,743,841
Other current liabilities	43,196,032	18,334,948
Total current liabilities	67,329,538	41,078,789
Long-Term Liabilities:
Long-term debt	194,361,169	73,381,014
Operating lease liability	9,500,133
Total liabilities	271,190,840	114,459,803
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: 241,277,076 and 240,462,439 issued and outstanding, respectively	241,277	240,463
Additional paid-in capital	624,515,559	616,559,938
Accumulated deficit	(645,985,765)	(519,276,280)
Total stockholders’ (deficit) equity	(21,228,929)	97,524,121
Total liabilities and stockholders’ equity	$ 249,961,911	$ 211,983,924

CONSOLIDATED BALANCE SHEETS (Pa

CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($)	Sep. 30, 2019	Dec. 31, 2018
Statement of Financial Position [Abstract]
allowance for doubtful accounts	$ 691,699	$ 596,602
Preferred Stock, Par or Stated Value 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 or Stated Value Per Share	$ 0.001	$ 0.001
Common Stock, Shares Authorized	350,000,000	350,000,000
Common Stock, Shares, Issued	241,277,076	240,462,439
Common Stock, Shares, Outstanding	241,277,076	240,462,439

CONSOLIDATED STATEMENT OF OPERA

CONSOLIDATED STATEMENT OF OPERATIONS - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2019	Sep. 30, 2018	Sep. 30, 2019	Sep. 30, 2018
Total revenue, net	$ 23,719,741	$ 3,473,535	$ 33,745,257	$ 11,009,937
Cost of goods sold	1,444,308	699,118	3,455,995	1,786,902
Gross profit	22,275,433	2,774,417	30,289,262	9,223,035
Operating expenses:
Sales, general, and administrative	45,126,986	30,354,072	121,378,519	80,578,079
Research and development	4,077,738	6,708,271	15,359,988	20,545,948
Depreciation and amortization	141,959	73,321	363,956	198,545
Total operating expenses	49,346,683	37,135,664	137,102,463	101,322,572
Operating loss	(27,071,250)	(34,361,247)	(106,813,201)	(92,099,537)
Loss on extinguishment of debt			(10,057,632)
Miscellaneous income	703,662	809,022	1,878,980	1,457,817
Interest expense	(5,599,005)	(2,053,077)	(11,717,632)	(2,584,459)
Total other expense	(4,895,343)	(1,244,055)	(19,896,284)	(1,126,642)
Loss before income taxes	(31,966,593)	(35,605,302)	(126,709,485)	(93,226,179)
Provision for income taxes
Net loss	$ (31,966,593)	$ (35,605,302)	$ (126,709,485)	$ (93,226,179)
Loss per share, basic and diluted:
Net loss per share, basic and diluted	$ (0.13)	$ (0.16)	$ (0.53)	$ (0.42)
Weighted average number of common shares outstanding, basic and diluted	241,261,299	228,107,240	241,163,994	220,466,673
Product [Member]
Total revenue, net	$ 8,213,341	$ 3,473,535	$ 18,238,857	$ 11,009,937
License and Service [Member]
Total revenue, net	$ 15,506,400	$ 0	$ 15,506,400

CONSOLIDATED STATEMENTS OF STOC

CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($)	Common Stock [Member]	Additional Paid-in Capital [Member]	Retained Earnings [Member]	Total
Beginning balance, value at Dec. 31, 2017	$ 216,430	$ 516,351,405	$ (386,659,120)	$ 129,908,715
Common Stock, Shares, Outstanding, Beginning Balance at Dec. 31, 2017	216,429,642
Shares issued for exercise of options, net	$ 154	43,902		44,056
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period	154,632
Share-based compensation		1,751,358		1,751,358
Net loss			(24,401,829)	(24,401,829)
Common Stock, Shares, Outstanding, Ending Balance at Mar. 31, 2018	216,584,274
Ending balance, value at Mar. 31, 2018	$ 216,584	518,146,665	(411,060,949)	107,302,300
Beginning balance, value at Dec. 31, 2017	$ 216,430	516,351,405	(386,659,120)	129,908,715
Common Stock, Shares, Outstanding, Beginning Balance at Dec. 31, 2017	216,429,642
Shares issued for exercise of options, net				$ 1,236,313
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period				1,446,876
Net loss				$ (93,226,179)
Common Stock, Shares, Outstanding, Ending Balance at Sep. 30, 2018	236,464,789
Ending balance, value at Sep. 30, 2018	$ 236,465	613,864,115	(479,885,299)	134,215,281
Beginning balance, value at Mar. 31, 2018	$ 216,584	518,146,665	(411,060,949)	107,302,300
Common Stock, Shares, Outstanding, Beginning Balance at Mar. 31, 2018	216,584,274
Shares issued for exercise of options, net	$ 250	1,084,689		1,084,939
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period	249,785
Share-based compensation		2,377,082		2,377,082
Net loss			(33,219,048)	(33,219,048)
Common Stock, Shares, Outstanding, Ending Balance at Jun. 30, 2018	216,834,059
Ending balance, value at Jun. 30, 2018	$ 216,834	521,608,436	(444,279,997)	77,545,273
Shares issued for exercise of options, net	$ 1,053	106,265		$ 107,318
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period	1,052,300			1,052,300
Share-based compensation		2,260,195		$ 2,260,195
Net loss			(35,605,302)	(35,605,302)
Common Stock, Shares, Outstanding, Ending Balance at Sep. 30, 2018	236,464,789
Shares issued in offering, net	$ 18,578	89,889,219		89,907,797
Stock Issued During Period, Shares, New Issues	18,578,430
Ending balance, value at Sep. 30, 2018	$ 236,465	613,864,115	(479,885,299)	134,215,281
Beginning balance, value at Dec. 31, 2018	$ 240,463	616,559,938	(519,276,280)	$ 97,524,121
Common Stock, Shares, Outstanding, Beginning Balance at Dec. 31, 2018	240,462,439			240,462,439
Share-based compensation		2,575,369		$ 2,575,369
Net loss			(39,506,375)	(39,506,375)
Common Stock, Shares, Outstanding, Ending Balance at Mar. 31, 2019	241,221,840
Shares issued for exercise of options and warrants, net	$ 759	99,348		100,107
Stock Issued During Period, Shares, Other	759,401
Ending balance, value at Mar. 31, 2019	$ 241,222	619,234,655	(558,782,655)	60,693,222
Beginning balance, value at Dec. 31, 2018	$ 240,463	616,559,938	(519,276,280)	$ 97,524,121
Common Stock, Shares, Outstanding, Beginning Balance at Dec. 31, 2018	240,462,439			240,462,439
Shares issued for exercise of options, net				$ 108,656
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period				331,619
Net loss				$ (126,709,485)
Common Stock, Shares, Outstanding, Ending Balance at Sep. 30, 2019	241,277,076			241,277,076
Ending balance, value at Sep. 30, 2019	$ 241,277	624,515,559	(645,985,765)	$ (21,228,929)
Beginning balance, value at Mar. 31, 2019	$ 241,222	619,234,655	(558,782,655)	60,693,222
Common Stock, Shares, Outstanding, Beginning Balance at Mar. 31, 2019	241,221,840
Share-based compensation		2,637,264		2,637,264
Net loss			(55,236,517)	(55,236,517)
Common Stock, Shares, Outstanding, Ending Balance at Jun. 30, 2019	241,221,840
Ending balance, value at Jun. 30, 2019	$ 241,222	621,871,919	(614,019,172)	8,093,969
Shares issued for exercise of options, net	$ 55	8,494		$ 8,549
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period	55,236			55,236
Share-based compensation		2,635,146		$ 2,635,146
Net loss			(31,966,593)	$ (31,966,593)
Common Stock, Shares, Outstanding, Ending Balance at Sep. 30, 2019	241,277,076			241,277,076
Ending balance, value at Sep. 30, 2019	$ 241,277	$ 624,515,559	$ (645,985,765)	$ (21,228,929)

CONSOLIDATED STATEMENTS OF CASH

CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)	9 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Statement of Cash Flows [Abstract]
Net loss	$ (126,709,485)	$ (93,226,179)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation of fixed assets	223,750	121,423
Amortization of intangible assets	140,206	77,123
Write off of patent and trademark cost	78,864
Non-cash operating lease expense	711,836
Provision for doubtful accounts	95,097	231,475
Loss on extinguishment of debt	10,057,632
Share-based compensation	7,859,357	6,388,635
Amortization of intellectual property license fee	15,998
Amortization of deferred financing fees	582,829	149,909
Changes in operating assets and liabilities:
Accounts receivable	(4,354,890)	(8,705,325)
Inventory	(7,265,174)	(892,863)
Other current assets	(1,128,515)	1,233,482
Accounts payable	1,389,665	7,284,493
Accrued expenses and other liabilities	3,402,511	8,670,986
Net cash used in operating activities	(114,900,319)	(78,666,841)
CASH FLOWS FROM INVESTING ACTIVITIES
Payment for intellectual property license		(20,000,000)
Patent costs	(1,068,542)	(748,906)
Purchase of fixed assets	(2,089,413)	(66,295)
Payment of security deposit	(20,420)	(11,485)
Net cash used in investing activities	(3,178,375)	(20,826,686)
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from Financing Agreement	200,000,000
Proceeds from exercise of options and warrants	108,656	1,236,313
Proceeds from sale of common stock, net of costs		89,907,797
Proceeds from Credit Agreement		75,000,000
Payment of deferred financing fees	(6,652,270)	(3,786,918)
Repayment of Credit Agreement	(81,660,719)
Net cash provided by financing activities	111,795,667	162,357,192
(Decrease) increase in cash	(6,283,027)	62,863,665
Cash, beginning of period	161,613,077	127,135,628
Cash, end of period	155,330,050	189,999,293
Interest paid	12,446,792	1,759,316
Amount accrued for intellectual property license	$ 20,000,000

NOTE 1 _ THE COMPANY

NOTE 1 – THE COMPANY	9 Months Ended
	Sep. 30, 2019
Organization, Consolidation and Presentation of Financial Statements [Abstract]
NOTE 1 – THE COMPANY	NOTE 1 – THE COMPANY TherapeuticsMD, Inc., a Nevada corporation, or TherapeuticsMD or the Company, has three ® ® ® ® ® ™ Nature of Business We are a women’s healthcare company focused on creating and commercializing innovative products to support the lifespan of women and championing awareness of women’s healthcare issues, specifically, for pregnancy prevention, pregnancy, childbirth, nursing, pre-menopause, and menopause. At TherapeuticsMD, we combine entrepreneurial spirit, clinical expertise, and business leadership to develop and commercialize health solutions that enable new standards of care for women. Our solutions range from advanced hormone therapy pharmaceutical products to patient-controlled, long-acting contraceptive. We also manufacture and distribute branded and generic prescription prenatal vitamins under the vitaMedMD® and BocaGreenMD® brands. With our SYMBODA™ technology, we are developing and commercializing advanced hormone therapy pharmaceutical products to enable delivery of bio-identical hormones through a variety of dosage forms and administration routes. Our commercialization plan allows us to efficiently leverage and grow our marketing and sales organization to commercialize our recently approved products. During 2018, the U.S. Food and Drug Administration, or FDA, approval of our drugs has transitioned our company from predominately focused on conducting research and development to one focused on commercializing our drugs. In July 2018, we launched our FDA-approved product, IMVEXXY (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy, or VVA, due to menopause. In April 2019, we launched our FDA-approved product BIJUVA, our hormone therapy combination of bio-identical 17ß-estradiol and bio-identical progesterone in a single, oral softgel capsule, for the treatment of moderate-to-severe vasomotor symptoms, or VMS, due to menopause in women with a uterus, which was approved by the FDA on October 28, 2018. In October 2019, we began a test and learn market introduction for our FDA-approved product ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system), the first and only patient-controlled, procedure-free, reversible prescription contraceptive option for women, which was approved by the FDA on August 10, 2018. We expect the full commercial launch of ANNOVERA in the first quarter of 2020. On July 30, 2018, we entered into an exclusive license agreement, or the Population Council License Agreement, with the Population Council, Inc., or the Population Council, to commercialize ANNOVERA in the U.S. In addition, on July 30, 2018, we entered into a license and supply agreement with Knight Therapeutics Inc., or Knight, pursuant to which we granted Knight an exclusive license to commercialize IMVEXXY and BIJUVA in Canada and Israel. On June 6, 2019, we entered into an exclusive license and supply agreement, or the License Agreement, with Theramex HQ UK Limited, or Theramex, to commercialize BIJUVA and IMVEXXY outside of the U.S., excluding Canada and Israel, or the Territory.

NOTE 2 _ BASIS OF PRESENTATION

NOTE 2 – BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS	9 Months Ended
	Sep. 30, 2019
Note 2 Basis Of Presentation And Recently Issued Accounting Pronouncements
NOTE 2 – 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, 2018, as filed with the Securities and Exchange Commission, or the SEC, from which we derived the accompanying consolidated balance sheet as of December 31, 2018. 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 August 2018, the Financial Accounting Standards Board, or the FASB, issued Accounting Standards Update, or ASU, 2018-13 which eliminates certain disclosure requirements for fair value measurements for all entities, requires public entities to disclose certain new information and modifies some disclosure requirements. The FASB developed the amendments to ASC 820 as part of its broader disclosure framework project, which aims to improve the effectiveness of disclosures in the notes to financial statements by focusing on requirements that clearly communicate the most important information to users of the financial statements. The new guidance is effective for all entities for fiscal years beginning after December 15, 2019 and for interim periods within those fiscal years. An entity is permitted to early adopt either the entire standard or only the provisions that eliminate or modify requirements. We are currently evaluating the effect of this guidance on our disclosures. In June 2018, the FASB issued ASU 2018-07 to simplify the accounting for share-based payments to nonemployees by aligning it with the accounting for share-based payments to employees, with certain exceptions. The new guidance expands the scope of ASC 718 to include share-based payments granted to nonemployees in exchange for goods or services used or consumed in an entity’s own operations and supersedes the guidance in ASC 505-50. The guidance is effective for public business entities in annual periods beginning after December 15, 2018, and interim periods within those annual periods. Early adoption is permitted, including in an interim period for which financial statements have not been issued, but not before an entity adopts ASC 606. We adopted this standard on January 1, 2019 and the adoption of this standard did not have a material effect on our consolidated financial statements. In February 2016, the FASB issued ASU 2016-02, Leases. This guidance requires lessees to record most leases on their balance sheets while recognizing 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 was effective for public business entities for annual periods beginning after December 15, 2018, and interim periods within those years. In July 2018, the FASB amended the new leases standard and issued ASU 2018-11, Leases, (Topic 842): Targeted Improvements to give entities another option for transition and to provide lessors with a practical expedient. We adopted ASU 2016-02 on January 1, 2019 utilizing the alternative transition method allowed for under ASU 2018-11 and we recorded a $ 3.8 million 4.1 million 7.4 million 7.2 million Other recent accounting pronouncements issued by the FASB (including its Emerging Issues Task Force), the American Institute of Certified Public Accountants and the SEC did not, and are not expected to, have a material effect on our results of operations or financial position.

NOTE 3 _ SUMMARY OF SIGNIFICANT

NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	9 Months Ended
	Sep. 30, 2019
Accounting Policies [Abstract]
NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Fair Value of Financial Instruments Our financial instruments consist primarily of cash, accounts receivable, accounts payable, accrued expenses and long-term debt. The carrying amount of cash, 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. The carrying amount for long-term debt as of September 30, 2019 (as disclosed in Note 9), approximates fair value based on market activity for other debt instruments with similar characteristics and comparable risk (Level 2). 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 September 30, 2019 and 2018, 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 the company’s impairment test on an annual basis. Trade Accounts Receivable and Allowance for Doubtful Accounts Trade accounts receivable are customer obligations due under normal trade terms. We review accounts receivable for uncollectible accounts and credit card chargebacks and provide an allowance for doubtful accounts, which is based upon a review of outstanding receivables, historical collection information, and existing economic conditions. We evaluate trade accounts receivable aged more than 90 days for delinquency. We write off delinquent receivables against our allowance for doubtful accounts based on individual credit evaluations, the results of collection efforts, and specific circumstances of customers. We record recoveries of accounts previously written off when received as an increase in the allowance for doubtful accounts. To the extent data we use to calculate these estimates does not accurately reflect bad debts, adjustments to these reserves may be required. Revenue Recognition We adopted ASC 606 on January 1, 2018 using the modified retrospective method for all contracts not completed as of the date of adoption. ASC 606 states that a contract is considered “completed” if all (or substantially all) of the revenue was recognized in accordance with revenue guidance that was in effect before the date of initial application. Because all (or substantially all) of the revenue related to sales of our products has been recognized under ASC 605 prior to the date of initial application of the new standard, the contracts are considered completed under ASC 606. Based on our evaluation of ASC 606, we concluded that a cumulative adjustment was not necessary upon implementation of ASC 606 on January 1, 2018. In accordance with ASC 606, revenue is recognized when a customer obtains control of promised goods or services. The amount of revenue recognized reflects the consideration to which we expect to be entitled to receive in exchange for these goods or services. The provisions of ASC 606 include a five-step process by which we determine revenue recognition, depicting the transfer of goods or services to customers in amounts reflecting the payment to which we expect to be entitled in exchange for those goods or services. ASC 606 requires us to apply the following steps: (1) identify the contract with the customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when, or as, we satisfy the performance obligation. Prescription Products As of September 30, 2019, our products consisted primarily of prescription vitamins and our FDA-approved products: IMVEXXY, which we began selling during the third quarter of 2018, BIJUVA, which we began selling in the second quarter of 2019, and ANNOVERA, which we began selling in the third quarter of 2019. We sell our name brand and generic prescription products primarily through wholesale distributors and retail pharmacies. We have one performance obligation related to prescription products sold through wholesale distributors, which is to transfer promised goods to a customer, and two performance obligations related to products sold through retail pharmacies, which are to: (1) transfer promised goods and (2) provide customer service for an immaterial fee. We treat shipping as a fulfillment activity rather than as a separate obligation. We recognize prescription revenue only when we satisfy performance obligations by transferring a promised good or service to a customer. A good or service is considered to be transferred when the customer receives the goods or service or obtains control. Control refers to the customer’s ability to direct the use of, and obtain substantially all of the remaining benefits from, an asset. Based on our contracts, we invoice customers once our performance obligations have been satisfied, at which point payment is unconditional. We disclose receivables from contracts with customers separately in the statement of financial position. Payment for goods or services sold by us is typically due between 30 and 60 days after an invoice is sent to the customer. The transaction price of a contract is the amount of consideration which we expect to be entitled to in exchange for transferring promised goods or services to a customer. Prescription products are sold at fixed wholesale acquisition cost, or WAC, determined based on our list price. However, the total transaction price is variable as it is calculated net of estimated product returns, chargebacks, rebates, coupons, discounts and wholesaler fees. These estimates are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to the customer) or a current liability (if the amount is payable to a party other than a customer). In order to determine the transaction price, we estimate the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract or each variable consideration. The estimated amount of variable consideration is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. In determining amounts of variable consideration to include in a contract’s transaction price, we rely on our historical experience and other evidence that supports our qualitative assessment of whether revenue would be subject to a significant reversal. We consider all the facts and circumstances associated with both the risk of a revenue reversal arising from an uncertain future event and the magnitude of the reversal if that uncertain event were to occur. Actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from our original estimates, we will adjust these estimates, which would affect net product revenue and earnings in the period such changes in estimates become known. We accept returns of unsalable prescription products sold through wholesale distributors 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 do not allow product returns for prescription products that have been dispensed to a patient. We estimate the amount of our product sales that may be returned by our customers and record this estimate as a reduction of revenue in the period the related product revenue is recognized. Where historical rates of return exist, we use history as a basis to establish a returns reserve for products shipped to wholesalers. For our newly launched products, for which the right of return exists but for which we currently do not have history of product returns, we estimate returns based on available industry data, our own sales information and our visibility into the inventory remaining in the distribution channel. At the end of each reporting period, we may decide to constrain revenue for product returns based on information from various sources, including channel inventory levels and dating and sell-through data, the expiration dates of products currently being shipped, price changes of competitive products and any introductions of generic products. We recognize the amount of expected returns as a refund liability, representing the obligation to return the customer’s consideration. Since our returns primarily consist of expired and short dated products that will not be resold, we do not record a return asset for the right to recover the goods returned by the customer at the time of the initial sale (when recognition of revenue is deferred due to the anticipated return). Return estimates are recorded in the accrued expenses and other current liabilities on the consolidated balance sheet. We offer various rebate and discount programs in an effort to maintain a competitive position in the marketplace and to promote sales and customer loyalty. We estimate the allowance for consumer rebates and coupons that we have offered based on our experience and industry averages, which is reviewed, and adjusted if necessary, on a quarterly basis. Estimates relating to these rebates and coupons are deducted from gross product revenues at the time the revenues are recognized. We record distributor fees based on amounts stated in contracts. Rebate and coupon estimates and distributor fees are recorded in accrued expenses and other current liabilities on the consolidated balance sheet. We estimate chargebacks based on number of units sold during the period taking into account prices stated in contracts and our historical experience. Estimates related to distributors fees, rebates, coupons and returns are disclosed in Note 8. We provide invoice discounts to our customers for prompt payment. Estimates relating to invoice discounts and chargebacks are deducted from gross product revenues at the time the revenues are recognized. As part of commercial launches for our FDA-approved prescription products, we introduce a co-pay assistance program where eligible enrolled patients, out of pocket cost is reduced to a more affordable price. This allows patients to access the product at a reasonable cost and is in line with our responsible pricing approach. We reimburse pharmacies for this discount through third-party vendors. We consider certain payments as consideration paid to the customer and reflect such payments as a reduction of the transaction price as we do not receive a distinct good or service related to these payments. The variable consideration is estimated based on contract prices, the estimated percentage of patients that will utilize the copay assistance, the average assistance paid, the estimated levels of inventory in the distribution channel and the current level of prescriptions covered by patients’ insurance. Payers may change coverage levels for our prescription products positively or negatively, at any time up to the time that we have formally contracted coverage with the payer. As such, the net transaction price of our prescription products is susceptible to such changes in coverage levels, which are outside the influence of the Company. As a result, we constrain revenue recognized for our prescription products to an amount that will not result in a significant revenue reversal in future periods. Our ability to estimate the net transaction price for our prescription products is constrained by our estimates of the amount to be paid for the co-pay assistance program which is directly related to the level of prescriptions paid for by insurance. As such, we record an accrual to reduce gross sales for the estimated co-pay and other patient assistance based on currently available third-party data and our internal analyses. We re-evaluate any constraint each reporting period. License Revenue License arrangements may consist of non-refundable upfront license fees, exclusive licensed rights to patented or patent pending technology, and various performance or sales milestones and future product royalty payments. Some of these arrangements are multiple element arrangements. Non-refundable up-front fees that are not contingent on any future performance by us, and do not require continuing involvement on our part, are recognized as revenue when the license term commences and the licensed data or technology is delivered. Disaggregation of revenue The following table provides information about disaggregated revenue by product mix for the three and nine months ended September 30, 2019 and 2018: Three Months Nine Months 2019 2018 2019 2018 Prescription vitamins $ 2,550,330 $ 3,261,459 $ 7,309,174 $ 10,797,861 IMVEXXY 4,772,354 212,076 9,904,744 212,076 BIJUVA 490,705 — 624,987 — ANNOVERA 399,952 — 399,952 — License revenue 15,506,400 — 15,506,400 — Net revenue $ 23,719,741 $ 3,473,535 $ 33,745,257 $ 11,009,937 Cost of Sales Cost of sales includes the cost of inventory, manufacturing, manufacturing overhead and supply chain costs, and product shipping and handling costs. Certain license agreements require the payment of royalties based on the sale of future products. Such royalties are recorded as a component of cost of sales. Additionally, the amortization of license fees or milestone payments related to licensed products are classified as components of cost of sales to the extent such payments become due in the future. 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. We amortize such compensation amounts, if any, over the respective 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, Compensation-Stock Compensation, to value options. Option valuation models require the input of assumptions, including the expected life of the stock-based awards, the estimated stock price volatility, the risk-free interest rate, and the expected dividend yield. 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 term of the instrument. Estimated volatility is a measure of the amount by which our stock price is expected to fluctuate each year during the term of the award. On January 1, 2017, we began using our own stock price in our volatility calculation along with the other peer entities whose stock prices were publicly available that were similar to our company and in 2019 we started using only our own stock price in the volatility calculation. Our calculation of estimated volatility is based on historical stock prices over a period equal to the expected term of the awards. The average expected life is based on the contractual terms of the stock option using the simplified method. We utilize a dividend yield of zero based on the fact that we have never paid cash dividends and have no current intention to pay cash dividends. Calculating share-based compensation expense requires the input of highly subjective judgment and assumptions, 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. We recognize the compensation expense for share-based compensation granted based on the grant date fair value estimated in accordance with ASC 718. We generally recognize the compensation expense on a straight-line basis over the employee’s requisite service period. Effective January 1, 2017, we account for forfeitures when they occur. On January 1, 2019, we adopted ASU 2018-07 which simplified the accounting for share-based payments to nonemployees by aligning it with the accounting for share-based payments to employees, with certain exceptions. The new guidance expanded the scope of ASC 718 to include share-based payments granted to nonemployees in exchange for goods or services used or consumed in an entity’s own operations and superseded the guidance in ASC 505-50. Prior to January 1, 2019, equity instruments issued to non-employees were recorded on a fair value basis, as required by ASC 505, Equity - Based Payments to Non-Employees. 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. CRO activity expenses include preclinical laboratory experiments and clinical trial studies. Other activity expenses include regulatory consulting and other 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. These consulting 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.

NOTE 4 _ INVENTORY

NOTE 4 – INVENTORY	9 Months Ended
	Sep. 30, 2019
Inventory Disclosure [Abstract]
NOTE 4 – INVENTORY	NOTE 4 – INVENTORY Inventory consists of the following: September 30, December 31, Finished product $ 5,011,192 $ 2,908,958 Work in process 1,005,575 339,312 Raw material 4,516,077 19,400 TOTAL INVENTORY $ 10,532,844 $ 3,267,670

NOTE 5 _ OTHER CURRENT ASSETS

NOTE 5 – OTHER CURRENT ASSETS	9 Months Ended
	Sep. 30, 2019
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]
NOTE 5 – OTHER CURRENT ASSETS	NOTE 5 – OTHER CURRENT ASSETS Other current assets consist of the following: September 30, December 31, Prepaid sales and marketing costs $ 1,313,192 $ 5,148,789 Deferred financing fees (Note 9) 550,757 1,898,074 Prepaid insurance 2,542,008 790,465 Other prepaid costs 6,172,303 2,997,365 TOTAL OTHER CURRENT ASSETS $ 10,578,260 $ 10,834,693

NOTE 6 _ FIXED ASSETS, NET

NOTE 6 – FIXED ASSETS, NET	9 Months Ended
	Sep. 30, 2019
Property, Plant and Equipment [Abstract]
NOTE 6 – FIXED ASSETS, NET	NOTE 6 – FIXED ASSETS, NET Fixed assets, net consist of the following: September 30, December 31, Accounting system $ 301,096 $ 301,096 Equipment 1,371,390 490,576 Furniture and fixtures 1,294,241 116,542 Computer hardware 80,211 80,211 Leasehold improvements 68,788 37,888 3,115,726 1,026,313 Accumulated depreciation ( 777,380 ) ( 553,630 ) TOTAL FIXED ASSETS, NET $ 2,338,346 $ 472,683 Depreciation expense for the three months ended September 30, 2019 and 2018 was $ 90,700 42,221 223,750 121,423

NOTE 7 _ INTANGIBLE ASSETS

NOTE 7 – INTANGIBLE ASSETS	9 Months Ended
	Sep. 30, 2019
Goodwill and Intangible Assets Disclosure [Abstract]
NOTE 7 – INTANGIBLE ASSETS	NOTE 7 – INTANGIBLE ASSETS The following table sets forth the gross carrying amount, accumulated amortization and net carrying amount of our intangible assets as of September 30, 2019 and December 31, 2018: September 30, 2019 Gross Carrying Amount Accumulated Amortization Net Weighted-Average Amortizable intangible assets: Approved hormone therapy drug candidate patents 3,138,308 ( 421,694 ) 2,716,614 13.25 years Hormone therapy drug candidate patent (pending) 1,937,691 — 1,937,691 n/a Non-amortizable intangible assets: Multiple trademarks 287,846 — 287,846 indefinite TOTAL $ 5,363,845 $ ( 421,694 ) $ 4,942,151 December 31, 2018 Gross Carrying Amount Accumulated Amortization Net Weighted-Average Amortizable intangible assets: OPERA ® $ 31,951 $ ( 10,484 ) $ 21,467 10.75 years Development costs of corporate website 91,743 ( 91,743 ) — n/a Approved hormone therapy drug candidate patents 2,234,129 ( 282,485 ) 1,951,644 14 Hormone therapy drug candidate patents (pending) 1,855,279 — 1,855,279 n/a Non-amortizable intangible assets: Multiple trademarks 264,289 — 264,289 indefinite TOTAL $ 4,477,391 $ ( 384,712 ) $ 4,092,679 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 78,864 As of September 30, 2019, we had 26 28 ● 12 six three ● Five four one 13 three ten ● One ● One five ● One ● One ● Two Amortization expense was $ 51,259 31,100 140,206 77,123 Estimated amortization expense for the next five years for the patent costs currently being amortized is as follows: Year Ending December 31, Estimated Amortization 2019 (3 months) $ 51,259 2020 $ 205,035 2021 $ 205,035 2022 $ 205,035 2023 $ 205,035 License Agreement with the Population Council On July 30, 2018, we entered into the Council License Agreement to commercialize ANNOVERA in the U.S. ANNOVERA became commercially available in the third quarter of 2019 and we expect the full commercial launch in the first quarter of 2020. Under the terms of the Council License Agreement, we paid the Population Council a milestone payment of $ 20,000,000 20,000,000 20,000,000 15,998 The Population Council is also eligible to receive milestone payments and royalties from commercial sales of ANNOVERA. We will assume responsibility for marketing expenses related to the commercialization of ANNOVERA. In addition, we are required to pay the Population Council, on a quarterly basis, step-based royalty payments based on annual net sales of ANNOVERA in the U.S. by the Company and its affiliates and permitted licensees as follows: (i) if annual net sales are less than or equal to $ 50,000,000 5 50,000,000 150,000,000 10 150,000,000 15 50 20 20,000,000 We assess our intangible assets for impairment if indicators are present or changes in circumstance suggest that impairment may exist. If impairment indicators are present or changes in circumstance suggest that impairment may exist, we perform a recoverability test by comparing the sum of the estimated undiscounted cash flows of each intangible asset to its carrying value on the consolidated balance sheet. If the undiscounted cash flows used in the recoverability test are less than the carrying value, we would determine the fair value of the intangible asset and recognize an impairment loss if the carrying value of the intangible asset exceeds its fair value. We also evaluate the remaining useful life of intangible assets subject to amortization on a periodic basis to determine whether events and circumstances would indicate impairment or warrant a revision to the remaining useful life. If the estimate of an intangible asset’s remaining useful life is changed, we will amortize the remaining carrying value of the intangible asset prospectively over the revised remaining useful life. License Agreement with Knight Therapeutics Inc. On July 30, 2018, we entered into a license and supply agreement, or the Knight License Agreement, with Knight pursuant to which we granted Knight an exclusive license to commercialize IMVEXXY and BIJUVA in Canada and Israel. Pursuant to the terms of the Knight License Agreement, Knight will pay us a milestone fee upon first regulatory approval in Canada of each of IMVEXXY and BIJUVA, sales milestone fees based upon certain aggregate annual sales in Canada and Israel of each of IMVEXXY and BIJUVA and royalties based on aggregate annual sales of each of IMVEXXY and BIJUVA in Canada and Israel. Knight will be responsible for all regulatory and commercial activities in Canada and Israel related to IMVEXXY and BIJUVA. We may terminate the Knight License Agreement if Knight does not submit all regulatory applications, submissions and/or registrations required for regulatory approval to use and commercialize IMVEXXY and BIJUVA in Canada and Israel within certain specified time periods. We also may terminate the Knight License Agreement if Knight challenges our patents. Either party may terminate the Knight License Agreement for any material breach by the other party that is not cured within certain specified time periods or if the other party files for bankruptcy or other related matters. In connection with the Knight License Agreement, Knight entered into a subscription agreement with us, pursuant to which Knight purchased 3,921,568 5.10 20,000,000 License Agreement with Theramex On June 6, 2019, we entered into an exclusive license and supply agreement, or the License Agreement, with Theramex, a leading, global specialty pharmaceutical company dedicated to women’s health, to commercialize BIJUVA and IMVEXXY outside of the U.S., excluding Canada and Israel, or the Territory. Under the terms of the License Agreement, Theramex paid us EUR 14 2 27.5 25 100

NOTE 8 _ OTHER CURRENT LIABILIT

NOTE 8 – OTHER CURRENT LIABILITIES	9 Months Ended
	Sep. 30, 2019
Payables and Accruals [Abstract]
NOTE 8 – OTHER CURRENT LIABILITIES	NOTE 8 – OTHER CURRENT LIABILITIES Other current liabilities consist of the following: September 30, December 31, Accrued payroll, bonuses and commission costs $ 4,536,358 $ 6,854,002 Accrued intellectual license fee 20,000,000 — Allowance for coupons and returns 7,079,005 5,294,120 Accrued sales and marketing costs 1,560,257 2,288,028 Accrued compensated absences 1,551,042 1,178,110 Allowance for wholesale distributor fees 2,375,894 792,891 Accrued legal and accounting expense 469,446 385,824 Accrued research and development 1,226,160 388,675 Operating lease liability 1,242,290 — Accrued rent — 365,155 Accrued rebates 2,543,456 412,570 Other accrued expenses 612,124 375,573 TOTAL OTHER CURRENT LIABILITIES $ 43,196,032 $ 18,334,948

NOTE 9 _ DEBT

NOTE 9 – DEBT	9 Months Ended
	Sep. 30, 2019
Debt Disclosure [Abstract]
NOTE 9 – DEBT	NOTE 9 – DEBT On April 24, 2019, we entered into a Financing Agreement, or the Financing Agreement, with TPG Specialty Lending, Inc., as administrative agent, or the Administrative Agent, various lenders from time to time party thereto, and certain of the Company’s subsidiaries party thereto from time to time as guarantors, which provides us with a $ 300,000,000 200,000,000 50,000,000 50,000,000 11,000,000 3-month LIBOR 7.75 2.70 prime rate 6.75 5.2 four 30.0 5.0 3.0 1.0 2.5 50,000,000 60,000,000 On May 1, 2018, we entered into a Credit and Security Agreement, or the Credit Agreement, with MidCap Financial Trust, or MidCap, as agent, or Agent, and as lender, and the additional lenders party thereto from time to time (together with MidCap as a lender, the Lenders), as amended. The Credit Agreement provided a secured term loan facility in an aggregate principal amount of up to $ 200,000,000 three one-month LIBOR 1.50 7.75 On April 24, 2019, we terminated the Credit Agreement. A portion of the initial tranche of borrowing under the Financing Agreement in the amount of approximately $ 81,661,000 4 4 10,057,632 1,816,747 120,146 As of September 30, 2019, we had $ 200,000,000 6,652,270 6,101,513 265,949 462,683 5,333,056 9,318,056 11 As of September 30, 2019 and December 31, 2018, the carrying value of debt consisted of the following: September 30, December 31, Financing Agreement $ 200,000,000 $ — Credit Agreement — 75,000,000 Debt discount and financing fees ( 5,638,831 ) ( 1,618,986 ) TOTAL LONG-TERM DEBT $ 194,361,169 $ 73,381,014

NOTE 10 _ NET LOSS PER SHARE

NOTE 10 – NET LOSS PER SHARE	9 Months Ended
	Sep. 30, 2019
Loss per share, basic and diluted:
NOTE 10 – NET LOSS PER SHARE	NOTE 10 – NET LOSS 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, par value $0.001 per share, or Common Stock, outstanding during the period. We compute diluted EPS based on the weighted-average number of shares of our Common Stock outstanding plus all potentially dilutive shares of our Common Stock outstanding during the period. Such potentially dilutive shares of our Common Stock consist of options, warrants and restricted stock awards and were excluded from the calculation of diluted EPS because their effect would have been antidilutive due to the net loss reported by us. 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 Nine months ended September 30, 2019 September 30, 2018 Stock options 24,849,984 24,837,349 Warrants 1,832,571 3,007,571 Restricted stock awards 1,240,000 — TOTAL 27,922,555 27,844,920

NOTE 11 _ STOCKHOLDERS_ EQUITY

NOTE 11 – STOCKHOLDERS’ EQUITY	9 Months Ended
	Sep. 30, 2019
Equity [Abstract]
NOTE 11 – STOCKHOLDERS’ EQUITY	NOTE 11 – STOCKHOLDERS’ EQUITY Preferred Stock At September 30, 2019, we had 10,000,000 0.001 Common Stock At September 30, 2019, we had 350,000,000 241,277,076 Issuances During the Three and Nine Months Ended September 30, 2019 During the three months ended September 30, 2019, certain individuals exercised stock options to purchase 55,236 8,549 331,619 108,656 12,097 11,834 Issuances During the Three and Nine Months Ended September 30, 2018 During the three months ended September 30, 2018, certain individuals exercised stock options to purchase 1,052,300 107,318 1,446,876 1,236,313 10,000 9,841 On August 1, 2018, we entered into an underwriting agreement with Goldman Sachs & Co. LLC, as representative of the underwriters, relating to an underwritten public offering of 12,745,098 5.10 30 1,911,764 69,908,000 20,000,000 Warrants to Purchase Common Stock As of September 30, 2019, we had warrants outstanding to purchase an aggregate of 1,832,571 2.2 years 0.24 8.20 2.62 The valuation methodology used to determine the fair value of our warrants 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, dividend rate and the term of the warrant. During the nine months ended September 30, 2019, we granted warrants to purchase 75,000 5.63 5 years 60.8 2.52 0 3.00 12 month 175,000 5.16 5 years 62.1 2.36 0 2.79 12 month 56,418 150,977 198,306 407,292 83,000 0.4 years During the nine months ended September 30, 2019, warrants to purchase 1,250,000 471,184 no 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. Generally, the options vest annually over four years or as determined by our board of directors, upon each option grant. Options may be exercised by paying the price for shares or on a cashless exercise basis after they have vested and prior to the specified expiration date provided and applicable exercise conditions are met, if any. The expiration date is generally ten years from the date the option is issued. As of September 30, 2019, there were non-qualified stock options to purchase 15,028,509 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. The Awards available under the 2012 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 2012 Plan. Generally, the options vest annually over four years or as determined by our board of directors, upon each option grant. Options may be exercised by paying the price for shares or on a cashless exercise basis after they have vested and prior to the specified expiration date provided and applicable exercise conditions are met, if any. The expiration date is generally ten years from the date the option is issued. As of September 30, 2019, there were non-qualified stock options to purchase 6,316,474 1,040,000 On June 20, 2019, we adopted the 2019 Plan to serve as an incentive for retaining qualified and competent key employees, officers, directors, and certain consultants and advisors of our company. The Awards available under the 2019 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 2019 Plan. Generally, the options vest annually over four years or as determined by our board of directors, upon each option grant. Options may be exercised by paying the price for shares or on a cashless exercise basis after they have vested and prior to the specified expiration date provided and applicable exercise conditions are met, if any. The expiration date is generally ten years from the date the option is issued. As of September 30, 2019, there were 13,779,632 11,294,999 2,395,333 89,300 unallocated shares previously available for issuance under the 2009 Plan that were not then subject to outstanding “Awards” (as defined in the 2009 Plan). Any shares subject to outstanding options or other equity “Awards” under the 2019 Plan, the 2012 Plan and the 2009 Plan that are forfeited, expire or otherwise terminate without issuance of the underlying shares, or if any such Award is settled for cash or otherwise does not result in the issuance of all or a portion of the shares subject to such Award (other than shares tendered or withheld in connection with the exercise of an Award or the satisfaction of withholding tax liabilities), the shares to which those Awards were subject, shall, to the extent of such forfeiture, expiration, termination, cash settlement or non-issuance, again be available for delivery with respect to Awards under the 2019 Plan. As of September 30, 2019, there were non-qualified stock options to purchase 3,505,001 200,000 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 nine months ended September 30, 2019 and 2018 are set forth in the table below. Nine months ended September 30, 2019 2018 Risk-free interest rate 1.83 2.54 2.78 2.82 Volatility 61.25 64.49 61.8 63.34 Term (in years) 5.5 6.5 5.5 6.25 Dividend yield 0.00 0.00 A summary of activity under the 2009, 2012 and 2019 Plans and related information follows: Number of Shares Underlying Stock Options Weighted Average Exercise Price Weighted Aggregate Intrinsic Value Balance at December 31, 2018 20,872,824 $ 4.93 5.94 years $ 12,239,876 Granted 4,419,501 $ 3.13 Exercised ( 343,716 ) $ 0.32 $ 1,426,828 Expired/Forfeited ( 98,625 ) $ 5.63 Balance at September 30, 2019 24,849,984 $ 4.67 6.05 years $ 13,761,778 Vested and Exercisable at September 30, 2019 17,601,027 $ 4.85 4.81 years $ 9,745,527 Unvested at September 30, 2019 7,248,957 $ 4.22 9.06 years $ 4,016,251 At September 30, 2019, our outstanding stock options had exercise prices ranging from $ 0.19 8.92 1.84 3.27 2,194,667 2,109,218 6,568,736 5,981,343 13,468,000 2.4 years Restricted Stock Awards Restricted stock awards granted under our 2009, 2012 and 2019 Plans entitle the holder to receive, at the end of vesting period, a specified number of shares of our Common Stock. Share-based compensation expense is measured by the market value of our Common Stock on the day of the grant. The shares vest ratably over the period specified in the grant. There is no partial vesting and any unvested portion is forfeited. On December 13, 2018, we granted 1,040,000 4.06 200,000 2.18 384,061 1,080,738 3,505,000 2.2 years 1,240,000 Cash-Settled Stock Appreciation Rights (SARs) On July 1, 2018, we issued cash-settled SARs to certain consultants and employees. The SARs plan year began on July 1, 2018 and ended on or immediately following June 30, 2019. SARs were granted with a grant price equal to the market value of a share of our Common Stock on the date of grant. Cash-settled SARs provided for the cash payment of the excess of the fair market value of our Common Stock on June 30, 2019 over the grant price. Cash-settled SARs have no effect on dilutive shares or shares outstanding as any appreciation of our Common Stock over the grant price is paid in cash and not in Common Stock. Cash settled SARs were recorded in our consolidated balance sheets as a liability until the date of exercise. The fair value of each SAR award was estimated using the Black-Scholes valuation model. In accordance with ASC Topic 718, “Stock Compensation,” the fair value of each SAR award was recalculated at the end of each reporting period and the liability and expense adjusted based on the new fair value and the percent vested. At June 30, 2019, the fair market value of our Common Stock was lower than the grant price of SARs and, as a result, the recorded liability was reversed and no cash payment was made.

NOTE 12 _ INCOME TAXES

NOTE 12 – INCOME TAXES	9 Months Ended
	Sep. 30, 2019
Income Tax Disclosure [Abstract]
NOTE 12 – 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 2019 as a result of (i) the losses recorded during the nine months ended September 30, 2019, (ii) additional losses expected for the remainder of 2019, 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 September 30, 2019, 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.

NOTE 13 _ RELATED PARTIES

NOTE 13 – RELATED PARTIES	9 Months Ended
	Sep. 30, 2019
Related Party Transactions [Abstract]
NOTE 13 – 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. and its affiliates, or Catalent, in the normal course of business. Agreements with Catalent 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 months ended September 30, 2019 and 2018, we were billed by Catalent approximately $ 2,196,000 830,000 4,118,000 2,774,000 425,000 88,000

NOTE 14 _ BUSINESS CONCENTRATIO

NOTE 14 – BUSINESS CONCENTRATIONS	9 Months Ended
	Sep. 30, 2019
Risks and Uncertainties [Abstract]
NOTE 14 – BUSINESS CONCENTRATIONS	NOTE 14 – BUSINESS CONCENTRATIONS We purchase our prescription products from several suppliers with approximately 36 28 26 three 100 one 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. During the nine months ended September 30, 2019, four 10 four 10 four 68 four 71 During the nine months ended September 30, 2019, PI Services accounted for approximately $ 1,935,000 6,397,000 2,226,000 1,863,000 1,559,000 3,057,000 1,834,000 1,399,000

NOTE 15 _ COMMITMENTS AND CONTI

NOTE 15 – COMMITMENTS AND CONTINGENCIES	9 Months Ended
	Sep. 30, 2019
Commitments and Contingencies Disclosure [Abstract]
NOTE 15 – COMMITMENTS AND CONTINGENCIES	NOTE 15 – COMMITMENTS AND CONTINGENCIES We adopted ASC 842 effective January 1, 2019. Substantially all our operating lease right-of-use assets and operating lease liabilities represent leases for office space used to conduct our business. Upon adoption, we have recognized a right-of-use asset and a lease liability for all leases that have commenced as of January 1, 2019. The right-of-use assets represent the right to use the leased asset for the lease term. The lease liabilities represent the present value of the lease payments under the lease. The right-of-use asset is initially measured at cost, which primarily comprises the initial amount of the lease liability, plus any initial direct costs incurred, less any lease incentives received. All right-of-use assets are reviewed for impairment. The lease liability is initially measured at the present value of the lease payments, discounted using our secured incremental borrowing rate for the same term as the underlying lease because the rates are not implicit in the leases. Some of our leases contain variable lease payments, including payments based on an index or rate. Variable lease payments based on an index or rate are initially measured using the index or rate in effect at lease commencement. Additional payments based on the change in an index or rate, or payments based on a change in our portion of the operating expenses are recorded as a period expense when incurred. Lease modifications result in remeasurement of the lease liability. Included in lease expense are any variable lease payments incurred in the period that were not included in the initial lease liability. 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 In October 2018, we entered into a lease for new corporate offices in Boca Raton, Florida. The lease includes 56,212 7,561 48,651 11 two 5 6,536 Supplemental lease information Right-of-use asset $ 10,459,635 Short-term operating lease liability (included in Other current liabilities) $ 1,242,290 Long-term operating lease liability $ 9,500,133 Weighted average remaining term 9 Weighted average discount rate 8.25 % Supplemental cash flow information Cash paid for amounts included in the measurement of lease liabilities for operating lease $ 849,440 Right-of-use assets obtained in exchange for lease obligation $ 11,171,471 The following table reconciles the undiscounted cash flows for all operating leases at September 30, 2019 to the operating lease liabilities recorded on the balance sheet: Years Ending December 31, 2019 (3 months) $ 314,670 2020 1,566,617 2021 2,198,541 2022 1,262,302 2023 1,293,859 Thereafter 9,363,136 Total undiscounted lease payments 15,999,125 Less: imputed interest (5,256,702 ) Present value of lease payments $ 10,742,423 During the three and nine months ended September 30, 2019, operating lease expense related to our real estate leases was approximately $ 458,000 1,062,000 257,000 772,000 Intellectual Property Licenses We have license agreements with third parties that provide for minimum royalty, license, and exclusivity payments to be paid by us for access to certain technologies. In addition, we pay royalties as a percent of revenue as described in Note 7, Intangible Assets, to these consolidated financial statements. Purchase commitments We have a manufacturing and supply agreement whereby we are required to purchase from Catalent a minimum number of softgels during the first contract year and a higher number of softgels after the first contract year. If the minimum order quantities of specific products are not met, we are required to pay Catalent 50

NOTE 16 _ SUBSEQUENT EVENTS

NOTE 16 – SUBSEQUENT EVENTS	9 Months Ended
	Sep. 30, 2019
Subsequent Events [Abstract]
NOTE 16 – SUBSEQUENT EVENTS	NOTE 16 – SUBSEQUENT EVENTS On October 24, 2019, we entered into an underwriting agreement with J.P. Morgan Securities LLC, as representative of the underwriters, relating to an underwritten public offering of 26,000,000 2.75 30 3,900,000 77.0 million

NOTE 3 _ SUMMARY OF SIGNIFICA_2

NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)	9 Months Ended
	Sep. 30, 2019
Accounting Policies [Abstract]
Fair Value of Financial Instruments	Fair Value of Financial Instruments Our financial instruments consist primarily of cash, accounts receivable, accounts payable, accrued expenses and long-term debt. The carrying amount of cash, 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. The carrying amount for long-term debt as of September 30, 2019 (as disclosed in Note 9), approximates fair value based on market activity for other debt instruments with similar characteristics and comparable risk (Level 2). 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 September 30, 2019 and 2018, 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 the company’s impairment test on an annual basis.
Trade Accounts Receivable and Allowance for Doubtful Accounts	Trade Accounts Receivable and Allowance for Doubtful Accounts Trade accounts receivable are customer obligations due under normal trade terms. We review accounts receivable for uncollectible accounts and credit card chargebacks and provide an allowance for doubtful accounts, which is based upon a review of outstanding receivables, historical collection information, and existing economic conditions. We evaluate trade accounts receivable aged more than 90 days for delinquency. We write off delinquent receivables against our allowance for doubtful accounts based on individual credit evaluations, the results of collection efforts, and specific circumstances of customers. We record recoveries of accounts previously written off when received as an increase in the allowance for doubtful accounts. To the extent data we use to calculate these estimates does not accurately reflect bad debts, adjustments to these reserves may be required.
Revenue Recognition	Revenue Recognition We adopted ASC 606 on January 1, 2018 using the modified retrospective method for all contracts not completed as of the date of adoption. ASC 606 states that a contract is considered “completed” if all (or substantially all) of the revenue was recognized in accordance with revenue guidance that was in effect before the date of initial application. Because all (or substantially all) of the revenue related to sales of our products has been recognized under ASC 605 prior to the date of initial application of the new standard, the contracts are considered completed under ASC 606. Based on our evaluation of ASC 606, we concluded that a cumulative adjustment was not necessary upon implementation of ASC 606 on January 1, 2018. In accordance with ASC 606, revenue is recognized when a customer obtains control of promised goods or services. The amount of revenue recognized reflects the consideration to which we expect to be entitled to receive in exchange for these goods or services. The provisions of ASC 606 include a five-step process by which we determine revenue recognition, depicting the transfer of goods or services to customers in amounts reflecting the payment to which we expect to be entitled in exchange for those goods or services. ASC 606 requires us to apply the following steps: (1) identify the contract with the customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when, or as, we satisfy the performance obligation. Prescription Products As of September 30, 2019, our products consisted primarily of prescription vitamins and our FDA-approved products: IMVEXXY, which we began selling during the third quarter of 2018, BIJUVA, which we began selling in the second quarter of 2019, and ANNOVERA, which we began selling in the third quarter of 2019. We sell our name brand and generic prescription products primarily through wholesale distributors and retail pharmacies. We have one performance obligation related to prescription products sold through wholesale distributors, which is to transfer promised goods to a customer, and two performance obligations related to products sold through retail pharmacies, which are to: (1) transfer promised goods and (2) provide customer service for an immaterial fee. We treat shipping as a fulfillment activity rather than as a separate obligation. We recognize prescription revenue only when we satisfy performance obligations by transferring a promised good or service to a customer. A good or service is considered to be transferred when the customer receives the goods or service or obtains control. Control refers to the customer’s ability to direct the use of, and obtain substantially all of the remaining benefits from, an asset. Based on our contracts, we invoice customers once our performance obligations have been satisfied, at which point payment is unconditional. We disclose receivables from contracts with customers separately in the statement of financial position. Payment for goods or services sold by us is typically due between 30 and 60 days after an invoice is sent to the customer. The transaction price of a contract is the amount of consideration which we expect to be entitled to in exchange for transferring promised goods or services to a customer. Prescription products are sold at fixed wholesale acquisition cost, or WAC, determined based on our list price. However, the total transaction price is variable as it is calculated net of estimated product returns, chargebacks, rebates, coupons, discounts and wholesaler fees. These estimates are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to the customer) or a current liability (if the amount is payable to a party other than a customer). In order to determine the transaction price, we estimate the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract or each variable consideration. The estimated amount of variable consideration is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. In determining amounts of variable consideration to include in a contract’s transaction price, we rely on our historical experience and other evidence that supports our qualitative assessment of whether revenue would be subject to a significant reversal. We consider all the facts and circumstances associated with both the risk of a revenue reversal arising from an uncertain future event and the magnitude of the reversal if that uncertain event were to occur. Actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from our original estimates, we will adjust these estimates, which would affect net product revenue and earnings in the period such changes in estimates become known. We accept returns of unsalable prescription products sold through wholesale distributors 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 do not allow product returns for prescription products that have been dispensed to a patient. We estimate the amount of our product sales that may be returned by our customers and record this estimate as a reduction of revenue in the period the related product revenue is recognized. Where historical rates of return exist, we use history as a basis to establish a returns reserve for products shipped to wholesalers. For our newly launched products, for which the right of return exists but for which we currently do not have history of product returns, we estimate returns based on available industry data, our own sales information and our visibility into the inventory remaining in the distribution channel. At the end of each reporting period, we may decide to constrain revenue for product returns based on information from various sources, including channel inventory levels and dating and sell-through data, the expiration dates of products currently being shipped, price changes of competitive products and any introductions of generic products. We recognize the amount of expected returns as a refund liability, representing the obligation to return the customer’s consideration. Since our returns primarily consist of expired and short dated products that will not be resold, we do not record a return asset for the right to recover the goods returned by the customer at the time of the initial sale (when recognition of revenue is deferred due to the anticipated return). Return estimates are recorded in the accrued expenses and other current liabilities on the consolidated balance sheet. We offer various rebate and discount programs in an effort to maintain a competitive position in the marketplace and to promote sales and customer loyalty. We estimate the allowance for consumer rebates and coupons that we have offered based on our experience and industry averages, which is reviewed, and adjusted if necessary, on a quarterly basis. Estimates relating to these rebates and coupons are deducted from gross product revenues at the time the revenues are recognized. We record distributor fees based on amounts stated in contracts. Rebate and coupon estimates and distributor fees are recorded in accrued expenses and other current liabilities on the consolidated balance sheet. We estimate chargebacks based on number of units sold during the period taking into account prices stated in contracts and our historical experience. Estimates related to distributors fees, rebates, coupons and returns are disclosed in Note 8. We provide invoice discounts to our customers for prompt payment. Estimates relating to invoice discounts and chargebacks are deducted from gross product revenues at the time the revenues are recognized. As part of commercial launches for our FDA-approved prescription products, we introduce a co-pay assistance program where eligible enrolled patients, out of pocket cost is reduced to a more affordable price. This allows patients to access the product at a reasonable cost and is in line with our responsible pricing approach. We reimburse pharmacies for this discount through third-party vendors. We consider certain payments as consideration paid to the customer and reflect such payments as a reduction of the transaction price as we do not receive a distinct good or service related to these payments. The variable consideration is estimated based on contract prices, the estimated percentage of patients that will utilize the copay assistance, the average assistance paid, the estimated levels of inventory in the distribution channel and the current level of prescriptions covered by patients’ insurance. Payers may change coverage levels for our prescription products positively or negatively, at any time up to the time that we have formally contracted coverage with the payer. As such, the net transaction price of our prescription products is susceptible to such changes in coverage levels, which are outside the influence of the Company. As a result, we constrain revenue recognized for our prescription products to an amount that will not result in a significant revenue reversal in future periods. Our ability to estimate the net transaction price for our prescription products is constrained by our estimates of the amount to be paid for the co-pay assistance program which is directly related to the level of prescriptions paid for by insurance. As such, we record an accrual to reduce gross sales for the estimated co-pay and other patient assistance based on currently available third-party data and our internal analyses. We re-evaluate any constraint each reporting period. License Revenue License arrangements may consist of non-refundable upfront license fees, exclusive licensed rights to patented or patent pending technology, and various performance or sales milestones and future product royalty payments. Some of these arrangements are multiple element arrangements. Non-refundable up-front fees that are not contingent on any future performance by us, and do not require continuing involvement on our part, are recognized as revenue when the license term commences and the licensed data or technology is delivered. Disaggregation of revenue The following table provides information about disaggregated revenue by product mix for the three and nine months ended September 30, 2019 and 2018: Three Months Nine Months 2019 2018 2019 2018 Prescription vitamins $ 2,550,330 $ 3,261,459 $ 7,309,174 $ 10,797,861 IMVEXXY 4,772,354 212,076 9,904,744 212,076 BIJUVA 490,705 — 624,987 — ANNOVERA 399,952 — 399,952 — License revenue 15,506,400 — 15,506,400 — Net revenue $ 23,719,741 $ 3,473,535 $ 33,745,257 $ 11,009,937
Cost of Sales	Cost of Sales Cost of sales includes the cost of inventory, manufacturing, manufacturing overhead and supply chain costs, and product shipping and handling costs. Certain license agreements require the payment of royalties based on the sale of future products. Such royalties are recorded as a component of cost of sales. Additionally, the amortization of license fees or milestone payments related to licensed products are classified as components of cost of sales to the extent such payments become due in the future.
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. We amortize such compensation amounts, if any, over the respective 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, Compensation-Stock Compensation, to value options. Option valuation models require the input of assumptions, including the expected life of the stock-based awards, the estimated stock price volatility, the risk-free interest rate, and the expected dividend yield. 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 term of the instrument. Estimated volatility is a measure of the amount by which our stock price is expected to fluctuate each year during the term of the award. On January 1, 2017, we began using our own stock price in our volatility calculation along with the other peer entities whose stock prices were publicly available that were similar to our company and in 2019 we started using only our own stock price in the volatility calculation. Our calculation of estimated volatility is based on historical stock prices over a period equal to the expected term of the awards. The average expected life is based on the contractual terms of the stock option using the simplified method. We utilize a dividend yield of zero based on the fact that we have never paid cash dividends and have no current intention to pay cash dividends. Calculating share-based compensation expense requires the input of highly subjective judgment and assumptions, 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. We recognize the compensation expense for share-based compensation granted based on the grant date fair value estimated in accordance with ASC 718. We generally recognize the compensation expense on a straight-line basis over the employee’s requisite service period. Effective January 1, 2017, we account for forfeitures when they occur. On January 1, 2019, we adopted ASU 2018-07 which simplified the accounting for share-based payments to nonemployees by aligning it with the accounting for share-based payments to employees, with certain exceptions. The new guidance expanded the scope of ASC 718 to include share-based payments granted to nonemployees in exchange for goods or services used or consumed in an entity’s own operations and superseded the guidance in ASC 505-50. Prior to January 1, 2019, equity instruments issued to non-employees were recorded on a fair value basis, as required by ASC 505, Equity - Based Payments to Non-Employees.
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. CRO activity expenses include preclinical laboratory experiments and clinical trial studies. Other activity expenses include regulatory consulting and other 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. These consulting 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.

NOTE 3 _ SUMMARY OF SIGNIFICA_3

NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)	9 Months Ended
	Sep. 30, 2019
Accounting Policies [Abstract]
The following table provides information about disaggregated revenue by product mix for the three and nine months ended September 30, 2019 and 2018:	The following table provides information about disaggregated revenue by product mix for the three and nine months ended September 30, 2019 and 2018: Three Months Nine Months 2019 2018 2019 2018 Prescription vitamins $ 2,550,330 $ 3,261,459 $ 7,309,174 $ 10,797,861 IMVEXXY 4,772,354 212,076 9,904,744 212,076 BIJUVA 490,705 — 624,987 — ANNOVERA 399,952 — 399,952 — License revenue 15,506,400 — 15,506,400 — Net revenue $ 23,719,741 $ 3,473,535 $ 33,745,257 $ 11,009,937

NOTE 4 _ INVENTORY (Tables)

NOTE 4 – INVENTORY (Tables)	9 Months Ended
	Sep. 30, 2019
Inventory Disclosure [Abstract]
Inventory consists of the following:	Inventory consists of the following: September 30, December 31, Finished product $ 5,011,192 $ 2,908,958 Work in process 1,005,575 339,312 Raw material 4,516,077 19,400 TOTAL INVENTORY $ 10,532,844 $ 3,267,670

NOTE 5 _ OTHER CURRENT ASSETS (

NOTE 5 – OTHER CURRENT ASSETS (Tables)	9 Months Ended
	Sep. 30, 2019
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]
Other current assets consist of the following:	Other current assets consist of the following: September 30, December 31, Prepaid sales and marketing costs $ 1,313,192 $ 5,148,789 Deferred financing fees (Note 9) 550,757 1,898,074 Prepaid insurance 2,542,008 790,465 Other prepaid costs 6,172,303 2,997,365 TOTAL OTHER CURRENT ASSETS $ 10,578,260 $ 10,834,693

NOTE 6 _ FIXED ASSETS, NET (Tab

NOTE 6 – FIXED ASSETS, NET (Tables)	9 Months Ended
	Sep. 30, 2019
Property, Plant and Equipment [Abstract]
Fixed assets, net consist of the following:	Fixed assets, net consist of the following: September 30, December 31, Accounting system $ 301,096 $ 301,096 Equipment 1,371,390 490,576 Furniture and fixtures 1,294,241 116,542 Computer hardware 80,211 80,211 Leasehold improvements 68,788 37,888 3,115,726 1,026,313 Accumulated depreciation ( 777,380 ) ( 553,630 ) TOTAL FIXED ASSETS, NET $ 2,338,346 $ 472,683

NOTE 7 _ INTANGIBLE ASSETS (Tab

NOTE 7 – INTANGIBLE ASSETS (Tables)	9 Months Ended
	Sep. 30, 2019
Goodwill and Intangible Assets Disclosure [Abstract]
The following table sets forth the gross carrying amount, accumulated amortization and net carrying amount of our intangible assets as of September 30, 2019 and December 31, 2018:	The following table sets forth the gross carrying amount, accumulated amortization and net carrying amount of our intangible assets as of September 30, 2019 and December 31, 2018: September 30, 2019 Gross Carrying Amount Accumulated Amortization Net Weighted-Average Amortizable intangible assets: Approved hormone therapy drug candidate patents 3,138,308 ( 421,694 ) 2,716,614 13.25 years Hormone therapy drug candidate patent (pending) 1,937,691 — 1,937,691 n/a Non-amortizable intangible assets: Multiple trademarks 287,846 — 287,846 indefinite TOTAL $ 5,363,845 $ ( 421,694 ) $ 4,942,151 December 31, 2018 Gross Carrying Amount Accumulated Amortization Net Weighted-Average Amortizable intangible assets: OPERA ® $ 31,951 $ ( 10,484 ) $ 21,467 10.75 years Development costs of corporate website 91,743 ( 91,743 ) — n/a Approved hormone therapy drug candidate patents 2,234,129 ( 282,485 ) 1,951,644 14 Hormone therapy drug candidate patents (pending) 1,855,279 — 1,855,279 n/a Non-amortizable intangible assets: Multiple trademarks 264,289 — 264,289 indefinite TOTAL $ 4,477,391 $ ( 384,712 ) $ 4,092,679
Estimated amortization expense for the next five years for the patent costs currently being amortized is as follows:	Estimated amortization expense for the next five years for the patent costs currently being amortized is as follows: Year Ending December 31, Estimated Amortization 2019 (3 months) $ 51,259 2020 $ 205,035 2021 $ 205,035 2022 $ 205,035 2023 $ 205,035

NOTE 8 _ OTHER CURRENT LIABIL_2

NOTE 8 – OTHER CURRENT LIABILITIES (Tables)	9 Months Ended
	Sep. 30, 2019
Payables and Accruals [Abstract]
Other current liabilities consist of the following:	Other current liabilities consist of the following: September 30, December 31, Accrued payroll, bonuses and commission costs $ 4,536,358 $ 6,854,002 Accrued intellectual license fee 20,000,000 — Allowance for coupons and returns 7,079,005 5,294,120 Accrued sales and marketing costs 1,560,257 2,288,028 Accrued compensated absences 1,551,042 1,178,110 Allowance for wholesale distributor fees 2,375,894 792,891 Accrued legal and accounting expense 469,446 385,824 Accrued research and development 1,226,160 388,675 Operating lease liability 1,242,290 — Accrued rent — 365,155 Accrued rebates 2,543,456 412,570 Other accrued expenses 612,124 375,573 TOTAL OTHER CURRENT LIABILITIES $ 43,196,032 $ 18,334,948

NOTE 9 _ DEBT (Tables)

NOTE 9 – DEBT (Tables)	9 Months Ended
	Sep. 30, 2019
Debt Disclosure [Abstract]
As of September 30, 2019 and December 31, 2018, the carrying value of debt consisted of the following:	As of September 30, 2019 and December 31, 2018, the carrying value of debt consisted of the following: September 30, December 31, Financing Agreement $ 200,000,000 $ — Credit Agreement — 75,000,000 Debt discount and financing fees ( 5,638,831 ) ( 1,618,986 ) TOTAL LONG-TERM DEBT $ 194,361,169 $ 73,381,014

NOTE 10 _ NET LOSS PER SHARE (T

NOTE 10 – NET LOSS PER SHARE (Tables)	9 Months Ended
	Sep. 30, 2019
Loss per share, basic and diluted:
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.	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 Nine months ended September 30, 2019 September 30, 2018 Stock options 24,849,984 24,837,349 Warrants 1,832,571 3,007,571 Restricted stock awards 1,240,000 — TOTAL 27,922,555 27,844,920

NOTE 11 _ STOCKHOLDERS_ EQUITY

NOTE 11 – STOCKHOLDERS’ EQUITY (Tables)	9 Months Ended
	Sep. 30, 2019
Equity [Abstract]
The assumptions used in the Black-Scholes Model for options granted during the nine months ended September 30, 2019 and 2018 are set forth in the table below.	The assumptions used in the Black-Scholes Model for options granted during the nine months ended September 30, 2019 and 2018 are set forth in the table below. Nine months ended September 30, 2019 2018 Risk-free interest rate 1.83 2.54 2.78 2.82 Volatility 61.25 64.49 61.8 63.34 Term (in years) 5.5 6.5 5.5 6.25 Dividend yield 0.00 0.00
A summary of activity under the 2009, 2012 and 2019 Plans and related information follows:	A summary of activity under the 2009, 2012 and 2019 Plans and related information follows: Number of Shares Underlying Stock Options Weighted Average Exercise Price Weighted Aggregate Intrinsic Value Balance at December 31, 2018 20,872,824 $ 4.93 5.94 years $ 12,239,876 Granted 4,419,501 $ 3.13 Exercised ( 343,716 ) $ 0.32 $ 1,426,828 Expired/Forfeited ( 98,625 ) $ 5.63 Balance at September 30, 2019 24,849,984 $ 4.67 6.05 years $ 13,761,778 Vested and Exercisable at September 30, 2019 17,601,027 $ 4.85 4.81 years $ 9,745,527 Unvested at September 30, 2019 7,248,957 $ 4.22 9.06 years $ 4,016,251

NOTE 15 _ COMMITMENTS AND CON_2

NOTE 15 – COMMITMENTS AND CONTINGENCIES (Tables)	9 Months Ended
	Sep. 30, 2019
Commitments and Contingencies Disclosure [Abstract]
Supplemental lease information	Supplemental lease information Right-of-use asset $ 10,459,635 Short-term operating lease liability (included in Other current liabilities) $ 1,242,290 Long-term operating lease liability $ 9,500,133 Weighted average remaining term 9 Weighted average discount rate 8.25 % Supplemental cash flow information Cash paid for amounts included in the measurement of lease liabilities for operating lease $ 849,440 Right-of-use assets obtained in exchange for lease obligation $ 11,171,471
The following table reconciles the undiscounted cash flows for all operating leases at September 30, 2019 to the operating lease liabilities recorded on the balance sheet:	The following table reconciles the undiscounted cash flows for all operating leases at September 30, 2019 to the operating lease liabilities recorded on the balance sheet: Years Ending December 31, 2019 (3 months) $ 314,670 2020 1,566,617 2021 2,198,541 2022 1,262,302 2023 1,293,859 Thereafter 9,363,136 Total undiscounted lease payments 15,999,125 Less: imputed interest (5,256,702 ) Present value of lease payments $ 10,742,423

NOTE 1 _ THE COMPANY (Details N

NOTE 1 – THE COMPANY (Details Narrative)	Sep. 30, 2019
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Number of subsidiaires	3

NOTE 2 _ BASIS OF PRESENTATIO_2

NOTE 2 – BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS (Details Narrative) - USD ($)	Sep. 30, 2019	Aug. 31, 2019	Jan. 02, 2019	Dec. 31, 2018
Note 2 Basis Of Presentation And Recently Issued Accounting Pronouncements
Operating Lease, Right-of-Use Asset	$ 10,459,635	$ 7,400,000	$ 3,800,000
Operating Lease, Liability	$ 10,742,423	$ 7,200,000	$ 4,100,000

The following table provides in

The following table provides information about disaggregated revenue by product mix for the three and nine months ended September 30, 2019 and 2018: (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2019	Sep. 30, 2018	Sep. 30, 2019	Sep. 30, 2018
Product Information [Line Items]
Revenue from Contract with Customer, Excluding Assessed Tax	$ 23,719,741	$ 3,473,535	$ 33,745,257	$ 11,009,937
Prescription Vitamins [Member]
Product Information [Line Items]
Revenue from Contract with Customer, Excluding Assessed Tax	2,550,330	3,261,459	7,309,174	10,797,861
Imvexxy
Product Information [Line Items]
Revenue from Contract with Customer, Excluding Assessed Tax	4,772,354	212,076	9,904,744	$ 212,076
BIJUVA [Member]
Product Information [Line Items]
Revenue from Contract with Customer, Excluding Assessed Tax	490,705		624,987
ANNOVERA [Member]
Product Information [Line Items]
Revenue from Contract with Customer, Excluding Assessed Tax	399,952		399,952
License and Service [Member]
Product Information [Line Items]
Revenue from Contract with Customer, Excluding Assessed Tax	$ 15,506,400	$ 0	$ 15,506,400

Inventory consists of the follo

Inventory consists of the following: (Details) - USD ($)	Sep. 30, 2019	Dec. 31, 2018
Inventory Disclosure [Abstract]
Finished product	$ 5,011,192	$ 2,908,958
Work in process	1,005,575	339,312
Raw material	4,516,077	19,400
TOTAL INVENTORY	$ 10,532,844	$ 3,267,670

Other current assets consist of

Other current assets consist of the following: (Details) - USD ($)	Sep. 30, 2019	Dec. 31, 2018
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]
Prepaid sales and marketing costs	$ 1,313,192	$ 5,148,789
Deferred financing fees (Note 9)	550,757	1,898,074
Prepaid insurance	2,542,008	790,465
Other prepaid costs	6,172,303	2,997,365
TOTAL OTHER CURRENT ASSETS	$ 10,578,260	$ 10,834,693

Fixed assets, net consist of th

Fixed assets, net consist of the following: (Details) - USD ($)	Sep. 30, 2019	Dec. 31, 2018
Property, Plant and Equipment [Line Items]
Property, Plant and Equipment, Gross	$ 3,115,726	$ 1,026,313
Accumulated Depreciation, Depletion and Amortization, Property, Plant, and Equipment	777,380	553,630
Property, Plant and Equipment, Net	2,338,346	472,683
Software and Software Development Costs [Member]
Property, Plant and Equipment [Line Items]
Property, Plant and Equipment, Gross	301,096	301,096
Equipment [Member]
Property, Plant and Equipment [Line Items]
Property, Plant and Equipment, Gross	1,371,390	490,576
Furniture and Fixtures [Member]
Property, Plant and Equipment [Line Items]
Property, Plant and Equipment, Gross	1,294,241	116,542
Computer Equipment [Member]
Property, Plant and Equipment [Line Items]
Property, Plant and Equipment, Gross	80,211	80,211
Leasehold Improvements [Member]
Property, Plant and Equipment [Line Items]
Property, Plant and Equipment, Gross	$ 68,788	$ 37,888

NOTE 6 _ FIXED ASSETS, NET (Det

NOTE 6 – FIXED ASSETS, NET (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2019	Sep. 30, 2018	Sep. 30, 2019	Sep. 30, 2018
Property, Plant and Equipment [Abstract]
Depreciation	$ 90,700	$ 42,221	$ 223,750	$ 121,423

The following table sets forth

The following table sets forth the gross carrying amount, accumulated amortization and net carrying amount of our intangible assets as of September 30, 2019 and December 31, 2018: (Details) - USD ($)	9 Months Ended	12 Months Ended
	Sep. 30, 2019	Dec. 31, 2018
Finite-Lived Intangible Assets [Line Items]
Finite-Lived Intangible Assets, Accumulated Amortization	$ 421,694	$ 384,712
Intangible Assets, Gross (Excluding Goodwill)	5,363,845	4,477,391
Intangible Assets, Net (Excluding Goodwill)	4,942,151	4,092,679
Hormone Therapy Drug Candidate Patents - (Pending) [Member]
Finite-Lived Intangible Assets [Line Items]
Finite-Lived Intangible Assets, Gross	1,937,691	1,855,279
Finite-Lived Intangible Assets, Net	1,937,691	1,855,279
Multiple Trademarks [Member]
Finite-Lived Intangible Assets [Line Items]
Indefinite-Lived Trademarks	287,846	264,289
Indefinite-lived Intangible Assets (Excluding Goodwill)	287,846	264,289
Approved Hormone Therapy Drug Candidate Patents [Member]
Finite-Lived Intangible Assets [Line Items]
Finite-Lived Intangible Assets, Gross	3,138,308	2,234,129
Finite-Lived Intangible Assets, Accumulated Amortization	421,694	282,485
Finite-Lived Intangible Assets, Net	$ 2,716,614	$ 1,951,644
Finite-Lived Intangible Assets, Remaining Amortization Period	13 years 3 months	14 years
Computer Software, Intangible Asset [Member]
Finite-Lived Intangible Assets [Line Items]
Finite-Lived Intangible Assets, Gross		$ 31,951
Finite-Lived Intangible Assets, Accumulated Amortization		10,484
Finite-Lived Intangible Assets, Net		$ 21,467
Finite-Lived Intangible Assets, Remaining Amortization Period		10 years 9 months
Internet Domain Names [Member]
Finite-Lived Intangible Assets [Line Items]
Finite-Lived Intangible Assets, Gross		$ 91,743
Finite-Lived Intangible Assets, Accumulated Amortization		91,743
Finite-Lived Intangible Assets, Net

Estimated amortization expense

Estimated amortization expense for the next five years for the patent costs currently being amortized is as follows: (Details)	Sep. 30, 2019USD ($)
Goodwill and Intangible Assets Disclosure [Abstract]
Finite-Lived Intangible Assets, Amortization Expense, Next Twelve Months	$ 51,259
Finite-Lived Intangible Assets, Amortization Expense, Year Two	205,035
Finite-Lived Intangible Assets, Amortization Expense, Year Three	205,035
Finite-Lived Intangible Assets, Amortization Expense, Year Four	205,035
Finite-Lived Intangible Assets, Amortization Expense, Year Five	$ 205,035

NOTE 7 _ INTANGIBLE ASSETS (Det

NOTE 7 – INTANGIBLE ASSETS (Details Narrative)	Aug. 05, 2019EUR (€)	Aug. 06, 2018USD ($)$ / sharesshares	Sep. 30, 2019USD ($)	Sep. 30, 2018USD ($)	Sep. 30, 2019USD ($)	Sep. 30, 2018USD ($)	Jun. 06, 2019EUR (€)
Finite-Lived Intangible Assets [Line Items]
Impairment of Intangible Assets, Indefinite-lived (Excluding Goodwill)					$ 78,864
Amortization of Intangible Assets			$ 51,259	$ 31,100	140,206	$ 77,123
Amortization of Other Deferred Charges					$ 15,998
Stock Issued During Period, Value, New Issues				$ 89,907,797
Subscription Agreement Knight [Member]
Finite-Lived Intangible Assets [Line Items]
Stock Issued During Period, Shares, New Issues | shares		3,921,568
Sale of Stock, Price Per Share | $ / shares		$ 5.10
Stock Issued During Period, Value, New Issues		$ 20,000,000
Council License Agreement [Member]
Finite-Lived Intangible Assets [Line Items]
Annual royalty rate reduction of initial rate during the six-month period from commercial sale of a generic equivalent					5000.00%
Annual royalty rate reduction of initial rate after the six-month period from commercial sale of a generic equivalent					2000.00%
maximum costs and expenses for post approval					$ 20,000,000
Council License Agreement [Member] | ANNOVERA [Member]
Finite-Lived Intangible Assets [Line Items]
Milestone payment upon FDA Approval			20,000,000
Milestone payments (payment after release of first commercial batch)			20,000,000		20,000,000
Finite-lived Intangible Assets Acquired			20,000,000
Amortization of Other Deferred Charges			$ 15,998		15,998
Council License Agreement [Member] | ANNOVERA [Member] | Step-based Royalty Payment One [Member] | Maximum [Member]
Finite-Lived Intangible Assets [Line Items]
Net sales amount per step-based royalty					$ 50,000,000
CouncilLicenseAgreementStep1Member
Finite-Lived Intangible Assets [Line Items]
Royalty (percent)					500.00%
CouncilLicenseAgreementStep2Member
Finite-Lived Intangible Assets [Line Items]
Royalty (percent)					1000.00%
CouncilLicenseAgreementStep2Member | Maximum [Member]
Finite-Lived Intangible Assets [Line Items]
Net sales amount per step-based royalty					$ 150,000,000
CouncilLicenseAgreementStep2Member | Minimum [Member]
Finite-Lived Intangible Assets [Line Items]
Net sales amount per step-based royalty					$ 50,000,000
CouncilLicenseAgreementStep3Member
Finite-Lived Intangible Assets [Line Items]
Royalty (percent)					1500.00%
CouncilLicenseAgreementStep3Member | Minimum [Member]
Finite-Lived Intangible Assets [Line Items]
Net sales amount per step-based royalty					$ 150,000,000
License Agreement Theramex Member
Finite-Lived Intangible Assets [Line Items]
Cash upfront payment received | €	€ 14,000,000
License Agreement Theramex Member | Maximum [Member]
Finite-Lived Intangible Assets [Line Items]
Regulatory milestone payments | €							€ 2,000,000
Sales milestone payment | €							€ 27,500,000
Sales milestone | €	100,000,000
License Agreement Theramex Member | Minimum [Member]
Finite-Lived Intangible Assets [Line Items]
Sales milestone | €	€ 25,000,000
Approved Hormone Therapy Drug Candidate Patents [Member]
Finite-Lived Intangible Assets [Line Items]
Finite-Lived Intangible Asset, Useful Life					20 years
Domestic US Patents
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			26		26
Foreign Patents Member
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			28		28
Domestic Patents BIJUVA
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			12		12
Foreign Patents BIJUVA
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			6		6
Domestic Patents NonApproved BIJUVA
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			3		3
Domestic US Patents IMVEXXY
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			5		5
Domestic US Utility Patents IMVEXXY
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			4		4
Domestic US Design Patents IMVEXXY
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			1		1
Foreign Patents IMVEXXY
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			13		13
Foreign Utility Patents IMVEXXY
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			3		3
Foreign Design Patents IMVEXXY
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			10		10
Domestic US Patents Topical Cream
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			1		1
Domestic Utility Patent Transdermal Patch
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			1		1
Foreign Utility Patent Transdermal Patch
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			5		5
Domestic Utility Patent Opera
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			1		1
Domestic Utility Patent DLimonene
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			1		1
Domestic Utility Patent TX009HR
Finite-Lived Intangible Assets [Line Items]
Number of issued patents			2		2

Other current liabilities consi

Other current liabilities consist of the following: (Details) - USD ($)	Sep. 30, 2019	Dec. 31, 2018
Payables and Accruals [Abstract]
Accrued payroll, bonuses and commission costs	$ 4,536,358	$ 6,854,002
Accrued intellectual license fee	20,000,000
Allowance for coupons and returns	7,079,005	5,294,120
Accrued sales and marketing costs	1,560,257	2,288,028
Accrued compensated absences	1,551,042	1,178,110
Allowance for wholesale distributor fees	2,375,894	792,891
Accrued legal and accounting expense	469,446	385,824
Accrued research and development	1,226,160	388,675
Operating lease liability	1,242,290
Accrued rent		365,155
Accrued rebates	2,543,456	412,570
Other accrued expenses	612,124	375,573
TOTAL OTHER CURRENT LIABILITIES	$ 43,196,032	$ 18,334,948

As of September 30, 2019 and De

As of September 30, 2019 and December 31, 2018, the carrying value of debt consisted of the following: (Details) - USD ($)	Sep. 30, 2019	Dec. 31, 2018
Debt Instrument [Line Items]
Debt Instrument, Unamortized Discount (Premium) and Debt Issuance Costs, Net	$ 5,638,831	$ 1,618,986
Long-term Debt, Excluding Current Maturities	194,361,169	73,381,014
Financing Agreement [Member]
Debt Instrument [Line Items]
Long-term Debt, Gross	$ 200,000,000
Credit Agreement Member
Debt Instrument [Line Items]
Long-term Debt, Gross		$ 75,000,000

NOTE 9 _ DEBT (Details Narrativ

NOTE 9 – DEBT (Details Narrative)	Apr. 24, 2019USD ($)	May 01, 2018USD ($)Tranch	Sep. 30, 2019USD ($)	Sep. 30, 2018USD ($)	Sep. 30, 2019USD ($)	Sep. 30, 2018USD ($)
Debt Instrument [Line Items]
Prepayment fee percentage	4.00%
Gain (Loss) on Extinguishment of Debt					$ 10,057,632
Amortization of Debt Issuance Costs					(582,829)	(149,909)
Payments of Financing Costs					6,652,270	3,786,918
Debt Instrument, Unamortized Discount			$ 6,101,513		6,101,513
Amortization of Debt Issuance Costs					$ 582,829	$ 149,909
Debt Instrument, Interest Rate, Effective Percentage			1100.00%		1100.00%
Financing Agreement [Member]
Debt Instrument [Line Items]
Long-term Debt, Gross			$ 200,000,000		$ 200,000,000
Interest Expense, Borrowings			5,333,056		9,318,056
Tranche 1 [Member]
Debt Instrument [Line Items]
Amortization of Debt Issuance Costs			(265,949)		(462,683)
Amortization of Debt Issuance Costs			$ 265,949		462,683
Revolving Credit Facility [Member]
Debt Instrument [Line Items]
Debt Instrument, Basis Spread on Variable Rate		775.00%
Secured Debt [Member]
Debt Instrument [Line Items]
Line of Credit Facility, Maximum Borrowing Capacity		$ 200,000,000
Debt Instrument, Description of Variable Rate Basis		one-month LIBOR
LIBOR floor rate		1.50%
[custom:NumberOfTranchesUnderTermLoanFacility-0] | Tranch		3
Financing Agreement [Member]
Debt Instrument [Line Items]
Debt Instrument, Description of Variable Rate Basis	3-month LIBOR
Debt Instrument, Basis Spread on Variable Rate	775.00%
LIBOR floor rate	2.70%
Number of quarterly principal installment payments	4
Prepayment fee for first two years funding (percent)	30.00%
Prepayment fee third year funding (percent)	5.00%
Prepayment fee fourth year funding (percent)	3.00%
Prepayment fee fifth year funding (percent)	1.00%
Facility fee paid (percent)	2.50%
Minimum cash balance requirement under credit agreement	$ 50,000,000
Financing Agreement [Member] | Prime Rate [Member]
Debt Instrument [Line Items]
Debt Instrument, Description of Variable Rate Basis	prime rate
Debt Instrument, Basis Spread on Variable Rate	6.75%
LIBOR floor rate	5.20%
Financing Agreement [Member] | Tranche 1 [Member]
Debt Instrument [Line Items]
Proceeds from Lines of Credit	$ 200,000,000
Financing Agreement [Member] | Tranche Two [Member]
Debt Instrument [Line Items]
Line of Credit Facility, Maximum Borrowing Capacity	50,000,000
Financing Agreement [Member] | Tranche Three [Member]
Debt Instrument [Line Items]
Line of Credit Facility, Maximum Borrowing Capacity	50,000,000
Revenue requirement to draw on term loan tranche	11,000,000
Financing Agreement [Member] | Tranche Two Three Member
Debt Instrument [Line Items]
Minimum cash balance requirement under credit agreement	60,000,000
Financing Agreement [Member] | Revolving Credit Facility [Member]
Debt Instrument [Line Items]
Line of Credit Facility, Maximum Borrowing Capacity	300,000,000
Credit Agreement [Member]
Debt Instrument [Line Items]
Repayment of debt with new credit facility	$ 81,661,000
[custom:RepaymentFeePercentage]	400.00%
Gain (Loss) on Extinguishment of Debt	$ 10,057,632
Interest Expense, Debt					(1,816,747)
Amortization of Debt Issuance Costs					(120,146)
Amortization of Debt Issuance Costs					$ 120,146

The table below presents potent

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. (Details) - shares	3 Months Ended		9 Months Ended
	Sep. 30, 2019	Sep. 30, 2018	Sep. 30, 2019	Sep. 30, 2018
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	27,922,555	27,844,920	27,922,555	27,844,920
Warrant [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	1,832,571	3,007,571	1,832,571	3,007,571
Share-based Payment Arrangement, Option [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	24,849,984	24,837,349	24,849,984	24,837,349
Restricted Stock [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	1,240,000	0	1,240,000	0

The assumptions used in the Bla

The assumptions used in the Black-Scholes Model for options granted during the nine months ended September 30, 2019 and 2018 are set forth in the table below. (Details) - Share-based Payment Arrangement, Option [Member]	9 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Risk-free interest rate	1.83%	2.78%
Risk-free interest rate	2.54%	2.82%
Volatility	61.25%	61.80%
Volatility	64.49%	63.34%
Dividend yield	0.00%	0.00%
Minimum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term	5 years 6 months	5 years 6 months
Maximum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term	6 years 6 months	6 years 3 months

A summary of activity under the

A summary of activity under the 2009, 2012 and 2019 Plans and related information follows: (Details) - USD ($)	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018	Sep. 30, 2019	Sep. 30, 2018	Dec. 31, 2018
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Exercised	55,236	1,052,300	331,619	1,446,876
Vested and Exercisable			4 years 292 days
Unvested			9 years 21 days 21 hours 36 minutes
Share-based Payment Arrangement, Option [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Balance, beginning			20,872,824
Balance, beginning			$ 4.93
Balance, ending			6 years 18 days 6 hours		5 years 343 days 2 hours 24 minutes
Balance, beginning			$ 12,239,876
Granted			4,419,501
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price			$ 3.13
Exercised			343,716
Share-based Compensation Arrangements by Share-based Payment Award, Options, Exercises in Period, Weighted Average Exercise Price			$ 0.32
Exercised			$ 1,426,828
Expired Forfeited			98,625
Share-based Compensation Arrangement by Share-based Payment Award, Options, Forfeitures and Expirations in Period, Weighted Average Exercise Price			$ 5.63
Balance, ending	24,849,984		24,849,984		20,872,824
Balance, ending	$ 4.67		$ 4.67		$ 4.93
Balance, ending	$ 13,761,778		$ 13,761,778		$ 12,239,876
Vested and Exercisable	17,601,027		17,601,027
Vested and Exercisable	$ 4.85		$ 4.85
Vested and Exercisable	$ 9,745,527		$ 9,745,527
Unvested	7,248,957		7,248,957
Unvested	$ 4.22		$ 4.22
Unvested	$ 4,016,251		$ 4,016,251

NOTE 11 _ STOCKHOLDERS_ EQUIT_2

NOTE 11 – STOCKHOLDERS’ EQUITY (Details Narrative) - USD ($)	Jul. 30, 2019	Dec. 13, 2018	Aug. 06, 2018	Aug. 01, 2018	Sep. 30, 2019	Sep. 30, 2018	Jun. 30, 2018	Mar. 31, 2018	Sep. 30, 2019	Sep. 30, 2018	Dec. 31, 2018
Class of Warrant or Right [Line Items]
Preferred Stock, Shares Authorized					10,000,000				10,000,000		10,000,000
Preferred Stock, Par or Stated Value Per Share					$ 0.001				$ 0.001		$ 0.001
Common Stock, Shares Authorized					350,000,000				350,000,000		350,000,000
Common Stock, Shares, Issued					241,277,076				241,277,076		240,462,439
Common Stock, Shares, Outstanding					241,277,076				241,277,076		240,462,439
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period					55,236	1,052,300			331,619	1,446,876
Stock Issued During Period, Value, Stock Options Exercised					$ 8,549	$ 107,318	$ 1,084,939	$ 44,056	$ 108,656	$ 1,236,313
Number of stock options exercised in cashless exercise (in shares)									12,097	10,000
Number of common stock issued during period for stock options exercised in cashless exercise (in shares)									11,834	9,841
Shares Issued, Price Per Share				$ 5.10
Proceeds from issuance public offering			$ 69,908,000
Stock Issued During Period, Value, New Issues						89,907,797
Warrants and Rights Outstanding					$ 1,832,571				$ 1,832,571
Weighted-average contractual remaining life									2 years 73 days
Weighted average exercise price of warrants (in dollars per share)									$ 2.62
Share-based Payment Arrangement, Noncash Expense									$ 7,859,357	$ 6,388,635
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized					13,779,632				13,779,632
Plan Awards Number of New Shares					11,294,999				11,294,999
Share-based Compensation Arrangement by Share-based Payment Award, Non-Option Equity Instruments, Outstanding, Number					1,240,000				1,240,000
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value									$ 1.84	$ 3.27
Share-based Payment Arrangement, Expense					$ 2,194,667	2,109,218			$ 6,568,736	$ 5,981,343
Share-based Payment Arrangement, Nonvested Award, Option, Cost Not yet Recognized, Amount					13,468,000				13,468,000
Restricted Stock or Unit Expense					384,061				1,080,738
Share-based Payment Arrangement, Nonvested Award, Excluding Option, Cost Not yet Recognized, Amount					$ 3,505,000				$ 3,505,000
Share-based Payment Arrangement, Option [Member]
Class of Warrant or Right [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period									343,716
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition									2 years 146 days
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number					24,849,984				24,849,984		20,872,824
Restricted Stock Units (RSUs) [Member]
Class of Warrant or Right [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value	$ 2.18	$ 4.06
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition									2 years 73 days
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period	200,000	1,040,000
2009 Long Term Incentive Compensation Plan [Member]
Class of Warrant or Right [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number					15,028,509				15,028,509
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized					89,300				89,300
2012 Stock Incentive Plan [Member]
Class of Warrant or Right [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number					6,316,474				6,316,474
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized					2,395,333				2,395,333
2012 Stock Incentive Plan [Member] | Restricted Stock [Member]
Class of Warrant or Right [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number					1,040,000				1,040,000
Plan 2019 [Member]
Class of Warrant or Right [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number					3,505,001				3,505,001
Plan 2019 [Member] | Restricted Stock [Member]
Class of Warrant or Right [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Non-Option Equity Instruments, Outstanding, Number					200,000				200,000
Minimum [Member]
Class of Warrant or Right [Line Items]
Range - exercise price of options					$ 0.19				$ 0.19
Maximum [Member]
Class of Warrant or Right [Line Items]
Range - exercise price of options					$ 8.92				$ 8.92
Warrants Member
Class of Warrant or Right [Line Items]
Share-based Payment Arrangement, Noncash Expense					$ 56,418	$ 150,977			$ 198,306	$ 407,292
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount					$ 83,000				$ 83,000
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition									146 days
Share-based Compensation Arrangement by Share-based Payment Award, Non-Option Equity Instruments, Exercised									1,250,000
[custom:NumberOfStockIssuedInCashlessExerciseOfWarrants]									471,184	0
Warrants Member | Minimum [Member]
Class of Warrant or Right [Line Items]
Class of Warrant or Right, Exercise Price of Warrants or Rights					$ 0.24				$ 0.24
Warrants Member | Maximum [Member]
Class of Warrant or Right [Line Items]
Class of Warrant or Right, Exercise Price of Warrants or Rights					8.20				8.20
Outside Consultants Warrants [Member]
Class of Warrant or Right [Line Items]
Class of Warrant or Right, Exercise Price of Warrants or Rights					$ 5.63	$ 5.16			$ 5.63	$ 5.16
Share-based Compensation Arrangement by Share-based Payment Award, Non-Option Equity Instruments, Granted									75,000	175,000
Share-based Goods and Nonemployee Services Transaction, Valuation Method, Expected Term									5 years	5 years
Share-based Goods and Nonemployee Services Transaction, Valuation Method, Expected Volatility Rate									60.80%	62.10%
Share-based Goods and Nonemployee Services Transaction, Valuation Method, Risk Free Interest Rate									252.00%	2.36%
Share-based Goods and Nonemployee Services Transaction, Valuation Method, Expected Dividend Rate									0.00%	0.00%
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value									$ 3	$ 2.79
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period									12 months	12 months
Underwriting Agreement Goldman Sachs [Member]
Class of Warrant or Right [Line Items]
Stock Issued During Period, Shares, New Issues				12,745,098
[custom:PeriodExercisableUnderwritersOption]				30 days
[custom:UnderwritersOptionGrantedInPeriodShares]				1,911,764
Subscription Agreement Knight [Member]
Class of Warrant or Right [Line Items]
Stock Issued During Period, Value, New Issues			$ 20,000,000

NOTE 13 _ RELATED PARTIES (Deta

NOTE 13 – RELATED PARTIES (Details Narrative) - Affiliated Entity [Member] - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2019	Sep. 30, 2018	Sep. 30, 2019	Sep. 30, 2018	Dec. 31, 2018
Related Party Transaction [Line Items]
Amount billed	$ 2,196,000	$ 830,000	$ 4,118,000	$ 2,774,000
Accounts Payable, Related Parties, Current	$ 425,000		$ 425,000		$ 88,000

NOTE 14 _ BUSINESS CONCENTRAT_2

NOTE 14 – BUSINESS CONCENTRATIONS (Details Narrative) - USD ($)	9 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Concentration Risk [Line Items]
Number of vendors - suppliers	3
Supplier Concentration Risk [Member]
Concentration Risk [Line Items]
Concentration risk	36.00%	100.00%
Number of vendors - suppliers		1
Supplier
Concentration Risk [Line Items]
Concentration risk	28.00%
Supplier
Concentration Risk [Line Items]
Concentration risk	26.00%
Customer Concentration Risk [Member] | Revenue Benchmark [Member]
Concentration Risk [Line Items]
Concentration risk	10.00%	10.00%
Number of customers - revenue	4	4
Three Customers Concentration Risk Member | Revenue Benchmark [Member]
Concentration Risk [Line Items]
Concentration risk	68.00%
Four Customers Concentration Risk Member | Revenue Benchmark [Member]
Concentration Risk [Line Items]
Concentration risk		71.00%
Customer Concentration P I Services Risk [Member] | Revenue Benchmark [Member]
Concentration Risk [Line Items]
Revenues	$ 1,935,000	$ 1,559,000
PillPack - Major Customer | Revenue Benchmark [Member]
Concentration Risk [Line Items]
Revenues	6,397,000	3,057,000
AmerisourceBergen - Major Customer | Revenue Benchmark [Member]
Concentration Risk [Line Items]
Revenues	2,226,000	1,834,000
Cardinal Health - Major Customer | Revenue Benchmark [Member]
Concentration Risk [Line Items]
Revenues	$ 1,863,000	$ 1,399,000

Supplemental lease information

Supplemental lease information (Details) - USD ($)	9 Months Ended
	Sep. 30, 2019	Aug. 31, 2019	Jan. 02, 2019	Dec. 31, 2018
Commitments and Contingencies Disclosure [Abstract]
Operating Lease, Right-of-Use Asset	$ 10,459,635	$ 7,400,000	$ 3,800,000
Operating Lease, Liability, Current	1,242,290
Operating Lease, Liability, Noncurrent	$ 9,500,133
Operating Lease, Weighted Average Remaining Lease Term	9 years
Operating Lease, Weighted Average Discount Rate, Percent	8.25%
Operating Lease, Payments	$ 849,440
Right-of-Use Asset Obtained in Exchange for Operating Lease Liability	$ 11,171,471

The following table reconciles

The following table reconciles the undiscounted cash flows for all operating leases at September 30, 2019 to the operating lease liabilities recorded on the balance sheet: (Details) - USD ($)	Sep. 30, 2019	Aug. 31, 2019	Jan. 02, 2019
Commitments and Contingencies Disclosure [Abstract]
2019 (3 months)	$ 314,670
2020	1,566,617
2021	2,198,541
2022	1,262,302
2023	1,293,859
Thereafter	9,363,136
Total undiscounted lease payments	15,999,125
Less: imputed interest	(5,256,702)
Present value of lease payments	$ 10,742,423	$ 7,200,000	$ 4,100,000

NOTE 15 _ COMMITMENTS AND CON_3

NOTE 15 – COMMITMENTS AND CONTINGENCIES (Details Narrative)	Jul. 01, 2013	Sep. 30, 2019USD ($)ft²	Sep. 30, 2018USD ($)	Sep. 30, 2019USD ($)ft²	Sep. 30, 2018USD ($)	Oct. 01, 2018ft²
Commitments and Contingencies Disclosure [Abstract]
Non-cancelable operating lease term	63 months
Net rentable area						56,212
Rented area lease						7,561
[custom:AdditionalAreaOfLeaseOccupied-0]						48,651
Lessee, Operating Lease, Term of Contract		11 years		11 years
Number of options to extend lease				2
Lessee, Finance Lease, Renewal Term		5 years		5 years
Lease not yet commenced (area)		6,536		6,536
Operating lease expense | $		$ 458,000	$ 257,000	$ 1,062,000	$ 772,000
[custom:SignificantSupplyCommitmentPercentagePayable-0]		50.00%		50.00%

NOTE 16 _ SUBSEQUENT EVENTS (De

NOTE 16 – SUBSEQUENT EVENTS (Details Narrative) - USD ($)	Oct. 29, 2019	Oct. 24, 2019	Aug. 06, 2018	Aug. 01, 2018
Subsequent Event [Line Items]
Shares Issued, Price Per Share				$ 5.10
Proceeds from issuance public offering			$ 69,908,000
Underwriting Agreement JP Morgan Chase
Subsequent Event [Line Items]
[custom:UnderwritersOptionGrantedInPeriodShares]				3,900,000
Subsequent Event [Member] | Underwriting Agreement JP Morgan Chase
Subsequent Event [Line Items]
Stock Issued During Period, Shares, New Issues		26,000,000
Shares Issued, Price Per Share		$ 2.75
[custom:PeriodExercisableUnderwritersOption]		30 days
Proceeds from issuance public offering	$ 77,000,000