Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 14, 2023 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2023 | |
Document Transition Report | false | |
Entity File Number | 001-39752 | |
Entity Registrant Name | Petros Pharmaceuticals, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 85-1410058 | |
Entity Address, Address Line One | 1185 Avenue of the Americas | |
Entity Address, Address Line Two | 3rd Floor | |
Entity Address, City or Town | New York | |
Entity Address State Or Province | NY | |
Entity Address, Postal Zip Code | 10036 | |
City Area Code | 973 | |
Local Phone Number | 242-0005 | |
Title of 12(b) Security | Common stock | |
Trading Symbol | PTPI | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 2,201,069 | |
Entity Central Index Key | 0001815903 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash | $ 17,969,949 | $ 9,426,264 |
Accounts receivable, net | 2,975,018 | 2,110,246 |
Inventories | 2,501,093 | 1,815,113 |
Prepaid expenses and other current assets | 987,120 | 1,316,282 |
Total current assets | 24,433,180 | 14,667,905 |
Fixed assets, net | 31,513 | 39,177 |
Intangible assets, net | 9,771,764 | 12,244,484 |
API purchase commitment | 4,416,862 | 5,111,176 |
Right of use assets | 260,849 | 358,472 |
Total assets | 38,914,168 | 32,421,214 |
Current liabilities: | ||
Current portion of promissory note | 1,139,458 | 1,089,683 |
Accounts payable | 1,355,060 | 1,806,399 |
Accrued expenses | 3,869,027 | 3,634,662 |
Accrued Series A Convertible Preferred payments payable | 1,368,546 | |
Other current liabilities | 349,972 | 537,232 |
Total current liabilities | 8,082,063 | 7,067,976 |
Promissory note, net of current portion | 7,248,635 | 8,388,093 |
Derivative Liability | 6,570,000 | |
Warrant Liability | 9,805,000 | |
Other long-term liabilities | 151,395 | 262,678 |
Total liabilities | 31,857,093 | 15,718,747 |
Commitments and contingencies | ||
Series A convertible redeemable preferred stock (par value $0.0001 per share and $1,000 stated value), 15,000 and 0 shares authorized at September 30, 2023 and December 31, 2022, respectively; 13,846 and 0 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively. Liquidation preference of $15,000,000 as of September 30, 2023 | 124,532 | |
Stockholders' Equity: | ||
Common stock (par value $0.0001 per share, 250,000,000 and 150,000,000 shares authorized at September 30, 2023 and December 31, 2022, respectively; 2,119,620 and 2,079,387 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively) | 211 | 208 |
Additional paid-in capital | 106,140,063 | 107,428,652 |
Accumulated deficit | (99,207,731) | (90,726,393) |
Total Stockholders' Equity | 6,932,543 | 16,702,467 |
Total Liabilities, Convertible Redeemable Preferred Stock and Stockholders' Equity | $ 38,914,168 | $ 32,421,214 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
CONDENSED CONSOLIDATED BALANCE SHEETS | ||
Redeemable convertible preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Redeemable convertible preferred stock, stated value | $ 1,000 | $ 1,000 |
Redeemable convertible preferred stock, authorized (in shares) | 15,000 | 0 |
Redeemable convertible preferred stock, issued (in shares) | 13,846 | 0 |
Redeemable convertible preferred stock, outstanding (in shares) | 13,846 | 0 |
Redeemable convertible preferred stock, Liquidation preference | $ 15,000,000 | |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 250,000,000 | 150,000,000 |
Common stock, shares issued | 2,119,620 | 2,079,387 |
Common stock, shares outstanding | 2,119,620 | 2,079,387 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||
Net sales | $ 1,674,657 | $ (1,457,732) | $ 6,186,638 | $ 5,193,953 |
Cost of goods sold | 408,475 | 286,525 | 1,473,073 | 1,408,086 |
Gross profit | 1,266,182 | (1,744,257) | 4,713,565 | 3,785,867 |
Operating expenses: | ||||
Selling, general and administrative | 2,001,935 | 2,170,975 | 6,382,166 | 9,285,317 |
Warrant issuance costs | 2,855,000 | 2,855,000 | ||
Gain on settlement with Vivus | (3,389,941) | |||
Research and development expense | 389,093 | 735,916 | 1,574,760 | 1,562,518 |
Depreciation and amortization expense | 826,795 | 1,560,870 | 2,480,385 | 4,682,610 |
Intangible asset impairment | 7,460,000 | 7,460,000 | ||
Total operating expenses | 6,072,823 | 11,927,761 | 13,292,311 | 19,600,504 |
Loss from operations | (4,806,641) | (13,672,018) | (8,578,746) | (15,814,637) |
Change in fair value of derivative liability | (430,000) | (430,000) | 460,000 | |
Change in fair value of warrant liability | (11,739,000) | (11,739,000) | ||
Interest income | 168,481 | 287,722 | ||
Interest expense, promissory note | (131,351) | (147,677) | (410,317) | (451,075) |
Loss on issuance of Series A Preferred Stock | (11,088,997) | (11,088,997) | ||
Loss before income taxes | (4,549,508) | (13,819,695) | (8,481,338) | (15,805,712) |
Income tax expense | 10,501 | 10,501 | ||
Net loss | (4,549,508) | (13,830,196) | (8,481,338) | (15,816,213) |
Preferred Stock dividends and cash premiums | (339,232) | (339,232) | ||
Net loss per common share | $ (4,888,740) | $ (13,830,196) | $ (8,820,570) | $ (15,816,213) |
Net loss per common share | ||||
Basic (in dollars per share) | $ (2.31) | $ (6.69) | $ (4.18) | $ (7.65) |
Diluted (in dollars per share) | $ (2.31) | $ (6.69) | $ (4.18) | $ (7.65) |
Denominator | ||||
Basic | 2,119,620 | 2,068,472 | 2,108,747 | 2,068,472 |
Diluted | 2,119,620 | 2,068,472 | 2,108,747 | 2,068,472 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN CONVERTIBLE REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY - USD ($) | Preferred Stock Convertible Redeemable Preferred Stock | Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
Balance at Dec. 31, 2021 | $ 207 | $ (70,688,820) | $ 35,544,964 | |||
Balance (in shares) at Dec. 31, 2021 | 2,068,472 | 106,233,577 | ||||
Stock-based compensation expense | $ 0 | $ 966,231 | 966,231 | |||
Non-employee exercise of restricted stock units | $ 0 | |||||
Non-employee exercise of restricted stock units (in shares) | 2,331 | |||||
Net income (loss) per common | $ 0 | (15,816,213) | (15,816,213) | |||
Balance at Sep. 30, 2022 | $ 207 | $ 207 | (86,505,033) | 20,694,982 | ||
Balance (in shares) at Sep. 30, 2022 | 2,070,803 | 2,070,803 | 107,199,808 | |||
Balance at Jun. 30, 2022 | $ 207 | (72,674,836) | 34,217,041 | |||
Balance (in shares) at Jun. 30, 2022 | 2,068,472 | 106,891,670 | ||||
Stock-based compensation expense | $ 0 | $ 308,138 | 308,138 | |||
Non-employee exercise of restricted stock units | $ 0 | |||||
Non-employee exercise of restricted stock units (in shares) | 2,331 | |||||
Net income (loss) per common | $ 0 | (13,830,196) | (13,830,196) | |||
Balance at Sep. 30, 2022 | $ 207 | $ 207 | (86,505,033) | 20,694,982 | ||
Balance (in shares) at Sep. 30, 2022 | 2,070,803 | 2,070,803 | 107,199,808 | |||
Balance at Dec. 31, 2022 | $ 0 | $ 208 | $ 107,428,652 | (90,726,393) | 16,702,467 | |
Balance (in shares) at Dec. 31, 2022 | 0 | 2,079,387 | ||||
Stock-based compensation expense | $ 0 | 204,492 | $ 0 | 204,492 | ||
Issuance of Series A Preferred Stock in private placement, net of discount and transaction costs $15,000,003 | 15,000 | 0 | 0 | |||
Preferred Stock redemption including cash premium (in shares) | (1,154) | |||||
Series A Preferred Stock accretion | $ 1,153,846 | $ 0 | (1,153,846) | $ 0 | (1,153,846) | |
Series A Preferred Stock dividends | 249,701 | 0 | (249,701) | 0 | (249,701) | |
Shares issued for vested RSU's | $ 3 | (3) | 0 | |||
Shares issued for vested RSU's (in shares) | 40,233 | |||||
Net income (loss) per common | $ 0 | (8,481,338) | (8,481,338) | |||
Balance at Sep. 30, 2023 | $ 124,531 | $ 211 | 106,140,063 | (99,207,731) | 6,932,543 | |
Balance (in shares) at Sep. 30, 2023 | 13,846 | 2,119,620 | ||||
Balance at Jun. 30, 2023 | $ 0 | $ 211 | 107,602,301 | (94,658,223) | 12,944,289 | |
Balance (in shares) at Jun. 30, 2023 | 2,119,620 | |||||
Stock-based compensation expense | $ 0 | 30,840 | 30,840 | |||
Issuance of Series A Preferred Stock in private placement, net of discount and transaction costs $15,000,003 | 15,000 | 0 | ||||
Preferred Stock redemption including cash premium (in shares) | (1,154) | |||||
Series A Preferred Stock accretion | $ 1,153,846 | $ 0 | (1,153,846) | (1,153,846) | ||
Series A Preferred Stock dividends | 249,701 | $ 0 | (249,701) | (249,701) | ||
Shares issued for vested RSU's (in shares) | 0 | |||||
Net income (loss) per common | $ 0 | (4,549,508) | (4,549,508) | |||
Balance at Sep. 30, 2023 | $ 124,531 | $ 211 | 106,140,063 | (99,207,731) | 6,932,543 | |
Balance (in shares) at Sep. 30, 2023 | 13,846 | 2,119,620 | ||||
Preferred Stock redemption including cash premium | $ (1,279,016) | $ 0 | $ (89,531) | $ 0 | $ (89,531) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN CONVERTIBLE REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (Parenthetical) - USD ($) | 3 Months Ended | 9 Months Ended |
Sep. 30, 2023 | Sep. 30, 2023 | |
Series A Preferred Stock | ||
Issuance of preferred stock in private placement net of discount and transaction costs | $ 15,000,003 | $ 15,000,003 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Cash flows from operating activities: | |||||
Net income (loss) | $ (8,481,338) | $ (15,816,213) | |||
Adjustments to reconcile net loss to net cash used in operating activities: | |||||
Depreciation and amortization | $ 826,795 | $ 1,560,870 | 2,480,385 | 4,682,610 | |
Intangible asset impairment | 7,460,000 | 7,460,000 | $ 7,460,000 | ||
Bad debt expense (recoveries) | 32,516 | (103,650) | |||
Inventory and sample inventory reserve | 41,195 | (14,688) | |||
Lease expense | 97,622 | 86,477 | |||
Change in fair value of derivative liability | 430,000 | 430,000 | (460,000) | ||
Change in fair value of warrant liability | (11,739,000) | (11,739,000) | |||
Loss on issuance of Series A Preferred Stock | 11,088,997 | ||||
Noncash Warrant expense | 1,595,000 | ||||
Gain on settlement with Vivus | (3,389,941) | ||||
Employee stock-based compensation | 204,492 | 966,231 | |||
Changes in operating assets and liabilities: | |||||
Accounts receivable | (897,289) | (1,174,106) | |||
Inventories | (63,191) | (1,619,694) | |||
Prepaid expenses and other current assets | 359,492 | 1,478,267 | |||
Accounts payable | (451,338) | (2,473,450) | |||
Accrued expenses | 234,364 | (954,607) | |||
Deferred revenue | (281,372) | 56,274 | |||
Other current liabilities | 94,113 | 154,370 | |||
Other long-term liabilities | (111,283) | (104,865) | |||
Net cash used in operating activities | (5,366,635) | (11,226,985) | |||
Cash flows from financing activities: | |||||
Payment of promissory note | (1,089,683) | (1,438,925) | |||
Proceeds from Private Placement, net of transactions costs | 15,000,003 | ||||
Net cash provided by (used in) financing activities | 13,910,320 | (1,438,925) | |||
Net increase (decrease) in cash | 8,543,685 | (12,665,910) | |||
Cash, beginning of period | 9,426,264 | 23,847,572 | 23,847,572 | ||
Cash, end of period | $ 17,969,949 | $ 11,181,662 | 17,969,949 | 11,181,662 | $ 9,426,264 |
Supplemental cash flow information: | |||||
Cash paid for interest during the period | 410,317 | 451,075 | |||
Noncash Items: | |||||
Noncash decrease in accrued expenses related to Vivus settlement | (6,520,283) | ||||
Noncash decrease in accrued inventory purchases related to Vivus Settlement | (14,203,905) | ||||
Noncash increase in promissory note related to Vivus settlement | 10,201,758 | ||||
Noncash increase in inventory due to API reclass | (663,984) | ||||
Noncash decrease in API purchase commitment | 694,314 | 6,232,489 | |||
Noncash decrease in other current assets: API purchase commitment | (30,330) | ||||
Noncash issuance of common stock to non-employee | 3 | $ 3 | |||
Noncash initial fair value of warrant liability pursuant to private placement | 21,544,000 | ||||
Noncash initial fair value of derivative liability pursuant to private placement | 6,140,000 | ||||
Accrued Series A Convertible Preferred payments payable | 1,368,546 | ||||
Accretion of Series A convertible preferred stock to redemption value | 1,250,000 | ||||
Accrual of Series convertible preferred stock dividends | $ 339,232 |
Nature of Operations, Basis of
Nature of Operations, Basis of Presentation, Liquidity and Going Concern | 9 Months Ended |
Sep. 30, 2023 | |
Nature of Operations, Basis of Presentation, Liquidity and Going Concern | |
Nature of Operations, Basis of Presentation, Liquidity and Going Concern | 1) Nature of Operations, Basis of Presentation, Liquidity and Going Concern Nature of Operations and Basis of Presentation Petros is a pharmaceutical company focused on expanding consumer access to medication through over-the-counter (OTC) drug development programs.Petros consists of wholly owned subsidiaries, Metuchen Pharmaceuticals LLC, a Delaware limited liability company (“Metuchen”), Neurotrope, Inc., a Nevada corporation (“Neurotrope”), Timm Medical Technologies, Inc. (“Timm Medical”), and Pos-T-Vac, LLC (“PTV”). Petros was organized as a Delaware corporation on May 14, 2020 for the purpose of effecting certain transactions between Petros, Metuchen, Neurotrope, and certain subsidiaries of Petros (collectively the “Mergers”). The Mergers were consummated on December 1, 2020. The Company is engaged in the commercialization and development of Stendra®, a U.S. Food and Drug Administration (“FDA”) approved PDE-5 inhibitor prescription medication for the treatment of erectile dysfunction (“ED”), which the Company has licensed from Vivus, Inc. (“Vivus”). Petros also markets its own line of ED products in the form of vacuum erection device products through its subsidiaries, Timm Medical and PTV. In addition to ED products, we had an exclusive global license to develop and commercialize H100™, a novel and patented topical formulation candidate for the treatment of acute Peyronie’s disease, which license was terminated by the Company on May 11, 2023. The Company manages its operations through two segments, Prescription Medications and Medical Devices, both of which focus on the treatment of male ED. The Prescription Medications segment consists primarily of Stendra®, which is sold generally in the United States. Expenses related to the development of H100™, prior to the license termination in May 2023, which was in the early stages of development and had not yet sought FDA approval to begin Phase 1 clinical trials, were categorized under the Prescription Medications segment. The Medical Devices segment consists primarily of vacuum erection devices, which are sold domestically and internationally. The Company’s priority is the ability to sell Stendra® Over-The-Counter (“OTC”). The company has continued to progress in its development program. Recently, the Company has conducted three engagements with the U.S. Food and Drug Administration (FDA) reviewing data and receiving guidance, launched a second pivotal Label Comprehension Study incorporating FDA feedback, and has begun to integrate supportive technology in response to recent FDA industry-wide guidance and proposed rules. Basis of Presentation The accompanying unaudited interim consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. In the opinion of management, the accompanying unaudited interim consolidated financial statements include all adjustments, consisting of normal recurring adjustments, considered necessary to present fairly our financial position, results of operations and cash flows. However, actual results could differ from those estimates. The unaudited interim consolidated results of operations are not necessarily indicative of the results that may occur for the full fiscal year. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been omitted pursuant to instructions, rules, and regulations prescribed by the United States Securities and Exchange Commission. This Quarterly Report on Form 10-Q should be read in conjunction with the audited financial statements and notes previously distributed in our Annual Report on Form 10-K for the year ended December 31, 2022. All transactions between the consolidated entities have been eliminated in consolidation. Liquidity and Going Concern We have experienced net losses and negative cash flows from operations since our inception. As of September 30, 2023, we had cash of approximately $18.0 million, working capital of $16.4 million, and accumulated deficit of $99.2 million. To date, our principal sources of capital used to fund our operations have been the revenues from product sales, private sales, registered offerings and private placements of equity securities. The Company does not currently have sufficient available liquidity to fund its operations for at least the next 12 months. These conditions and events raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that these interim condensed consolidated financial statements are issued. The accompanying condensed consolidated financial statements do not include any adjustments that might result from these uncertainties. In response to these conditions and events, the Company is evaluating various financing strategies to obtain sufficient additional liquidity to meet its operating, debt service and capital requirements for the next twelve months following the date of this Quarterly Report. The potential sources of financing that the Company is evaluating include one or any combination of secured or unsecured debt, convertible debt and equity in both public and private offerings. The Company also plans to finance near-term operations with its cash on hand, including the gross proceeds of $15 million raised in the Private Placement (see the section below titled “Liquidity and Capital Resources—July 2023 Private Placement”), as well as by exploring additional ways to raise capital and increasing cash flows from operations. The company intends to use the proceeds from the July 2023 capital raise to funds its OTC progress into 2024. There is no assurance the Company will manage to raise additional capital or otherwise increase cash flows, if required. The sources of financing described above that could be available to the Company and the timing and probability of obtaining sufficient capital depend, in part, on expanding the use of Stendra® and continuing to invest in research and development pursuant to our Non-Prescription / OTC strategies related to Stendra®, which we believe has the potential to dramatically increase product sales in the future; and future capital market conditions. If the Company’s current assumptions regarding timing of these events are incorrect or if there are any other changes or differences in our current assumptions that negatively impact our financing strategy, the Company may have to further reduce expenditures or significantly delay, scale back or discontinue the development or commercialization of Stendra® OTC in order to extend its cash resources. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2) Summary of Significant Accounting Policies Use of Estimates The preparation of Consolidated Financial Statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosures of contingent assets and liabilities at the date of the Consolidated Financial Statements and reported amounts of revenue and expenses during the reporting periods. Such estimates include the adequacy of accounts receivable reserves, return reserves, inventory reserves, assessment of long-lived assets, including intangible asset impairment and the valuation of the derivative liability, among others. Actual results could differ from these estimates and changes in these estimates are recorded when known. Risks and Uncertainties The Company is subject to risks common to companies in the pharmaceutical industry including, but not limited to, uncertainties related to commercialization of competitor products, regulatory approvals, dependence on key products, dependence on key customers and suppliers, Stendra(R) OTC approval, and protection of intellectual property rights. Concentration of Credit Risk Financial instruments that subject the Company to concentrations of credit risk includes cash. The Company maintains cash on deposit at U.S.-based banks in amounts which, at times, exceed insured limits. Segment Reporting Operating segments are components of a Company for which separate financial information is available and evaluated regularly by the chief operating decision maker in assessing performance and deciding how to allocate resources. The Company’s two segments, Prescription Medications and Medical Devices, focus on the treatment of male erectile dysfunction. The Prescription Medications segment consists primarily of operations related to Stendra®, which is sold generally in the United States The Medical Devices segment consists primarily of operations related to vacuum erection devices, which are sold domestically and internationally. See Note 15 Segment Reporting. Revenue Recognition Prescription Medication Sales The Company’s prescription medication sales consist of sales of Stendra® in the U.S. for the treatment of male erectile dysfunction. Under Accounting Standards Codification (“ASC”) Topic 606, Revenue Recognition (“Topic 606”), the Company recognizes revenue from prescription medication sales when its performance obligations with a customer has been satisfied. In the contracts with its customers, the Company has identified a single performance obligation to provide Stendra® upon receipt of a customer order. The performance obligation is satisfied at a point in time when the Company’s customers obtain control of Stendra®, which is typically upon delivery. The Company invoices its customers after Stendra® has been delivered and invoice payments are generally due within 30 to 75 days of invoice date. In determining the transaction price, a significant financing component does not exist since the timing from when the Company delivers Stendra® to when the customers pay for the product is typically less than one year. The Company records prescription medication sales net of any variable consideration, including but not limited to discounts, rebates, returns, chargebacks, and distribution fees. The Company uses the expected value method when estimating its variable consideration, unless terms are specified within contracts. The identified variable consideration is recorded as a reduction of revenue at the time revenues from sales of Stendra® are recognized. The Company recognizes revenue to the extent that it is probable that a significant revenue reversal will not occur in a future period. These estimates may differ from actual consideration received. The Company evaluates these estimates each reporting period to reflect known changes. As of September 30, 2023 and December 31, 2022, the reserves for sales deductions were $3.4 million and $3.0 million, respectively. The most significant sales deductions included in this reserve relate to returns, contract rebates, and distribution service (“DSA”) fees. Our estimates are based on factors such as our direct and indirect customers’ buying patterns and the estimated resulting contractual deduction rates, historical experience, specific known market events and estimated future trends, current contractual and statutory requirements, industry data, estimated customer inventory levels, current contract sales terms with our direct and indirect customers, and other competitive factors. Significant judgment and estimation is required in developing the foregoing and other relevant assumptions. The most significant sales deductions are further described below. Product Returns Consistent with industry practice, the Company maintains a return policy that generally allows its customers to return Stendra® and receive credit for product within six months prior to expiration date and up to one year Contract Rebates, Coupon Redemptions and DSA Fees The Company establishes contracts with wholesalers, chain stores, and indirect customers that provide for rebates, sales incentives, DSA fees and other allowances. Some customers receive rebates upon attaining established sales volumes. Direct rebates are generally rebates paid to direct purchasing customers based on a percentage applied to a direct customer’s purchases from us, including fees paid to wholesalers under our DSAs, as described below. Indirect rebates are rebates paid to indirect customers that have purchased our products from a wholesaler under a contract with us. The Company has entered into DSAs with certain of our significant wholesaler customers that obligate the wholesalers, in exchange for fees paid by us, to: (i) manage the variability of their purchases and inventory levels within specified limits based on product demand and (ii) provide us with specific services, including the provision of periodic retail demand information and current inventory levels for our pharmaceutical products held at their warehouse locations. See Note 3 Accounts Receivable, net for further discussion of these reserves. Accrued contracts were $49,499, $279,018 and $379,242 of September 30, 2023, December 31, 2022, and December 31, 2021, respectively. Medical Device Sales The Company’s medical device sales consist of domestic and international sales of men’s health products for the treatment of erectile dysfunction. The men’s health products include Vacuum Erection Devices, and VenoSeal. Under Topic 606, the Company recognizes revenue from medical device sales when its performance obligations with its customers have been satisfied. In the contracts with its customers, the Company has identified a single performance obligation to provide medical devices upon receipt of a customer order. The performance obligation is satisfied at a point in time when the Company’s customers obtain control of the medical device, which is typically upon shipment. The Company invoices its customers after the medical devices have been shipped and invoice payments are generally due within 30 days of invoice date for domestic customers and 90 days for international customers. In determining the transaction price, a significant financing component Product Returns Consistent with industry practice, the Company maintains a return policy that generally allows its customers to return medical devices and receive credit for products within 90 days of the sale. The provision for returns is based upon the Company’s estimates for future product returns and historical experience. As of September 30, 2023, December 31, 2021 and December 31, 2022, the reserves for product returns for medical devices were not significant. Contract Costs In relation to customer contracts, the Company incurs costs to fulfill a contract but does not incur costs to obtain a contract. These costs to fulfill a contract do not meet the criteria for capitalization and are expensed as incurred. As such, the Company did not have any contract assets at September 30, 2023, December 31, 2021 and December 31, 2022. Contract Liabilities Under Accounting Standards Codification Topic 606, Revenue Recognition, the Company recognizes revenue when its performance obligations with a customer has been satisfied. In the event it has not been satisfied, the Company records deferred revenue as a liability on the balance sheet. As of September 30, 2023, December 31, 2022, and December 31, 2021, deferred revenue was $0, $281,372 and $70,343 respectively. Fair Value Measurements In accordance with ASC 820 (Topic 820, Fair Value Measurements and Disclosures), we use a three-level hierarchy for fair value measurements of certain assets and liabilities for financial reporting purposes that distinguishes between market participant assumptions developed from market data obtained from outside sources (observable inputs) and our own assumptions about market participant assumptions developed from the best information available to us in the circumstances (unobservable inputs). The fair value hierarchy is divided into three levels based on the source of inputs as follows: ● Level 1 – inputs to the valuation methodology are quoted prices (unadjusted) for identical assets or liabilities in active markets; ● Level 2 – inputs to the valuation methodology include quoted prices for similar assets and liabilities in active markets, and inputs that are observable for the asset or liability other than quoted prices, either directly or indirectly including inputs in markets that are not considered to be active; and ● Level 3 – inputs to the valuation methodology are unobservable and significant to the fair value measurement. Categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. Intangible Assets The Company accounts for recognized intangible assets at cost. Intangible assets with finite useful lives are amortized over the useful life which the assets are expected to contribute directly or indirectly to future cash flows. Intangible assets are amortized using an accelerated method based on the pattern in which the economic benefits of the assets are consumed. The Company reviews the carrying value and useful lives of its intangible assets with definite lives whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable or the period over which they should be amortized has changed. When indicators of impairment exist, the Company determines whether the estimated undiscounted sum of the future cash flows of such assets is less than their carrying amounts. If less, an impairment loss is recognized in the amount, if any, by which the carrying amount of such assets exceeds their respective fair values. The Company evaluates the remaining useful life of each intangible asset that is being amortized during each reporting period to determine whether events and circumstances warrant a revision to the remaining period of amortization. If the estimate of the intangible asset’s remaining useful life has changed, the remaining carrying amount of the intangible asset is amortized prospectively over that revised remaining useful life. During the three months ended September 30, 2022, the Company noted that indicators of impairment existed and prepared an undiscounted cash flow analysis, which indicated, for the Stendra(R) product an impairment. The Company then prepared a discounted cash flow analysis resulting in an impairment of approximately $7.5 million. Derivative Financial Instruments The Company evaluates all its financial instruments to determine if such instruments contain features that qualify as embedded derivatives. Embedded derivatives must be separately measured from the host contract if all the requirements for bifurcation are met. The assessment of the conditions surrounding the bifurcation of embedded derivatives depends on the nature of the host contract. Bifurcated embedded derivatives are recognized at fair value, with changes in fair value recognized in the statement of operations each period. Bifurcated embedded derivatives are classified separately from the related host contract in the Company’s balance sheet. Basic and Diluted Net Loss per Common Share The Company computes basic net loss per common share by dividing net loss applicable to common stockholders by the weighted average number of shares of common stocks outstanding during the period, excluding the anti-dilutive effects of stock options and warrants to purchase common stocks. The Company computes diluted net loss per common stock by dividing the net loss applicable to common stocks by the sum of the weighted-average number of common stocks outstanding during the period plus the potential dilutive effects of its convertible preferred stocks, stock options and warrants to purchase common stocks, but such items are excluded if their effect is anti-dilutive. Because the impact of these items is anti-dilutive during periods of net loss, there was no difference between the Company’s basic and diluted net loss per share of common stock for the three and nine months ended September 30, 2023 and 2022. See Note 12 Basic and Diluted Net Loss per Common Share. Recent Accounting Pronouncements In June 2016, the Financial Accounting Standard Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-13, Measurement of Credit Losses on Financial Instruments. ASU 2016-13, together with a series of subsequently issued related ASUs, has been codified in Topic 326. Topic 326 establishes new requirements for companies to estimate expected credit losses when measuring certain financial assets, including accounts receivables. The Company adopted the new guidance with its fiscal year beginning January 1, 2023. The adoption of ASC 326 did not have a material effect on the Company’s financial statements. In August 2020, the Financial Accounting Standards Board issued Accounting Standards Update (“ASU”) 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”) to simplify certain financial instruments. ASU 2020-06 eliminates the current models that require separation of beneficial conversion and cash conversion features from convertible instruments and simplifies the derivative scope exception guidance pertaining to equity classification of contracts in an entity’s own equity. The new standard also introduces additional disclosures for convertible debt and freestanding instruments that are indexed to and settled in an entity’s own equity. ASU 2020-06 amends the diluted earnings per share guidance, including the requirement to use the if-converted method for all convertible instruments. ASU 2020-06 is effective for fiscal years beginning after December 15, 2021 and should be applied on a full or modified retrospective basis. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. The Company adopted ASU 2020-06 effective July 1, 2023. The adoption of ASU 2020-06 did not have a material impact on the Company’s financial statements. |
Accounts Receivable, net
Accounts Receivable, net | 9 Months Ended |
Sep. 30, 2023 | |
Accounts Receivable, net | |
Accounts Receivable, net | 3) Accounts Receivable, net Accounts receivable, net is comprised of the following: September 30, December 31, December 31, 2023 2022 2021 Gross accounts receivables $ 3,713,405 $ 2,757,839 $ 3,363,827 Distribution service fees (358,661) (339,094) (371,310) Chargebacks accrual (7,375) (1,960) — Cash discount allowances (132,967) (99,671) (159,446) Allowance for doubtful accounts (239,384) (206,868) (377,685) Total accounts receivable, net $ 2,975,018 $ 2,110,246 $ 2,455,386 For the nine months ended September 30, 2023, gross billings to customers representing 10% or more of the Company’s total gross billings included three customers which represented approximately 23%, 19%, and 17% of total gross billings, respectively. For the nine months ended September 30, 2022, gross billing from customers representing 10% or more of the Company’s total gross billings included four customers which represented approximately 27%, 22%, and 18% and 15% of total gross billings, respectively. Receivables from customers representing 10% or more of the Company’s gross accounts receivable included three customers at September 30, 2023 equal to 43%, 25%, and 14%, respectively. Receivables from customers representing 10% or more of the Company’s gross accounts receivable included two customers at December 31, 2022 equal to 43% and 16%, respectively. |
Inventories
Inventories | 9 Months Ended |
Sep. 30, 2023 | |
Inventories | |
Inventories | 4) Inventories Inventory is comprised of the following: September 30, 2023 December 31, 2022 Raw Materials $ 2,391,190 $ 1,574,683 Finished goods 109,903 240,430 Total inventory $ 2,501,093 $ 1,815,113 Finished goods are net of valuation reserves of $405,495 and $364,300 as of September 30, 2023 and December 31, 2022, respectively. Raw materials are net of valuation reserves of $2,872,977 as of September 30, 2023 and December 31, 2022, which is related to bulk inventory. |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 9 Months Ended |
Sep. 30, 2023 | |
Prepaid Expenses and Other Current Assets. | |
Prepaid Expenses and Other Current Assets | 5) Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets are comprised of the following: September 30, 2023 December 31, 2022 Prepaid insurance $ 169,588 $ 109,414 Prepaid coupon fees — 71,500 API purchase commitment asset (see Note 13) 694,314 663,984 Other prepaid expenses 65,655 333,158 Other current assets 57,563 138,226 Total prepaid expenses and other current assets $ 987,120 $ 1,316,282 |
Intangible Assets
Intangible Assets | 9 Months Ended |
Sep. 30, 2023 | |
Intangible Assets | |
Intangible Assets | 6) Intangible Assets Balance at December 31, 2021 $ 25,293,149 Amortization expense (5,588,665) Intangible Impairment (7,460,000) Balance at December 31, 2022 12,244,484 Amortization expense (2,472,720) Balance at September 30, 2023 $ 9,771,764 The future annual amortization related to the Company’s intangible assets is as follows as of September 30, 2023: 2023 (remaining 3 months) $ 800,027 2024 2,800,623 2025 1,754,328 2026 1,442,186 2027 1,212,871 Thereafter 1,761,729 Total $ 9,771,764 The intangible assets held by the Company are the Stendra® product, Timm Medical product, and PTV product and are being amortized over their estimated useful lives of 10 years, 12 years, and 12 years, respectively. The carrying value of the Stendra® product, Timm Medical product, and PTV product as of September 30, 2023 are $5.5 million, $3.4 million and $0.9 million, respectively. The carrying value of the Stendra® product, Timm Medical product, and PTV product as of December 31, 2022 were $7.2 million, $4.0 million and $1.1 million, respectively. During the three months ended September 30, 2022, the Company determined that the intangible asset related to the Stendra® product was impaired resulting in an impairment charge of approximately $7.5 million. |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2023 | |
Accrued Expenses | |
Accrued Expenses | 7) Accrued Expenses Accrued expenses are comprised of the following: September 30, 2023 December 31, 2022 Accrued product returns $ 2,853,413 $ 2,311,647 Accrued contract rebates 49,499 279,018 Due to 3PL/Wholesalers 103,161 155,081 Accrued bonuses 421,523 427,500 Accrued professional fees — 51,620 Other accrued expenses 441,431 409,796 Total accrued expenses $ 3,869,027 $ 3,634,662 |
Debt
Debt | 9 Months Ended |
Sep. 30, 2023 | |
Debt | |
Debt | 8) Debt Promissory Note In connection with the Settlement Agreement entered into with Vivus (see Note 13), Petros executed an interest-bearing promissory note (the “Note”) in favor of Vivus in the principal amount of $10,201,758. The parties also entered into a Security Agreement to secure Petros’ obligations under the Note. Under the terms of the Note, the original principal amount of $10,201,758 is payable in consecutive quarterly installments of principal and interest beginning on April 1, 2022 through January 1, 2027. Interest on the principal amount will accrue at a rate of 6% per year. The Company may prepay the Note, in whole or in part, at any time, with no premium or penalty. In the event that the Company defaults under the Security Agreement, all principal outstanding under the Note at the time of the default will bear interest at a rate of 9% per year until the full and final payment of all principal and interest under the Note (regardless of whether any default is waived or cured). Pursuant to the Security Agreement, dated January 18, 2022, the Company granted to Vivus a continuing security interest in all of its Stendra® API and products and its rights under the License Agreement. Future minimum principal payments of the promissory note are as follows: 2024 1,530,729 2025 2,720,940 2026 3,264,351 2027 872,073 Total $ 8,388,093 Less: current portion (1,139,458) Promissory note, net of current portion $ 7,248,635 |
Operating Leases
Operating Leases | 9 Months Ended |
Sep. 30, 2023 | |
Operating Leases | |
Operating Leases | 9) Operating Leases The Company has commitments under operating leases for office and warehouse space used in its operations. As of September 30, 2023 the Company’s leases have remaining lease terms ranging from .9 years to 3.3 years. On November 30, 2021, the Company entered into a sublease with respect to its entire headquarters facility. The sublessee delivered a $14,000 security deposit to the Company on the lease commencement date and also agreed to pay $7,000 per month for the term beginning January 10, 2022 and continuing until the expiration of the head lease on August 30, 2024. The Company accounts for this sublease as an operating lease in accordance with the lessor accounting guidance within ASC 842. The components of lease expense consisted entirely of fixed lease costs related to operating leases. These costs were $134,435 and $134,435 for the nine months ended September 30, 2023 and 2022, respectively, and were $44,812 and $44,812 for the three months ended September 30, 2023 and 2022, respectively. Fixed lease costs for the nine months ended September 30, 2023 were offset by sublease income of $63,000, and $21,000 for the three months ended September 30, 2023. Supplemental balance sheet information related to leases was as follows: As of September 30, 2023 As of December 31, 2022 Operating lease ROU asset: Other assets $ 260,849 $ 358,472 Operating lease liability: Other current liabilities 148,758 142,340 Other long-term liabilities 151,395 262,677 Total operating lease liability $ 300,153 $ 405,017 Supplemental lease term and discount rate information related to leases was as follows: As of September 30, 2023 As of December 31, 2022 Weighted-average remaining lease terms - operating leases 1.9 years 2.7 years Weighted-average discount rate - operating leases 12.6 % 12.6 % Supplemental cash flow information related to leases was as follows: For the Nine Months For the Three Months Ended September 30, Ended September 30, 2023 2022 2023 2022 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 141,677 $ 140,805 $ 47,226 $ 46,935 Future minimum lease payments under non-cancelable leases as of September 30, 2023, were as follows: Lease Liability Maturity Analysis Operating Leases 2023 (remaining 3 months) $ 47,697 2024 155,242 2025 81,107 2026 82,324 Thereafter — Total lease payments 366,370 Less: Imputed Interest (66,217) Total $ 300,153 Future minimum sublease income under non-cancelable leases as of September 30, 2023, were as follows: Sublease income Operating Leases 2023 (remaining 3 months) 21,000 2024 56,000 Total $ 77,000 As of September 30, 2023, the Company had no operating leases that had not yet commenced. |
Stock Options and Restricted St
Stock Options and Restricted Stock Units ("RSU's") | 9 Months Ended |
Sep. 30, 2023 | |
Stock Options and Restricted Stock Units ("RSU's") | |
Stock Options and Restricted Stock Units ("RSU's") | 10) Stock Options and Restricted Stock Units (“RSU’s”) The Company established the 2020 Omnibus Incentive Compensation plan (the “2020 Plan”) which provides for the grants of awards to our directors, officers, employees, and consultants. The 2020 Plan authorizes the grant of incentive stock options, nonqualified stock options, stock appreciation rights, stock awards, stock units and other stock-based awards and cash-based awards. On December 22, 2021, our stockholders approved the Second Amendment to the 2020 Plan to increase the total number of shares of common stock issuable under the 2020 Plan by 152,166 shares to a total of 260,000 shares of common stock. On September 14, 2023, our stockholders approved the Third Amendment to the 2020 Plan to increase the total number of shares of common stock issuable under the 2020 Plan by 2.5 million shares to a total of 2,760,000 shares of common stock. As of September 30, 2023, there were 2,760,000 shares authorized and 2,507,369 shares available for issuance under the 2020 Plan. The following is a summary of stock options for the nine months ended September 30, 2023 and for the year ended December 31, 2022: Weighted-Average Weighted- Remaining Aggregate Intrinsic Number of Average Contractual Value Shares Exercise Price Term (Years) ($ in thousands) Options outstanding at December 31, 2022 59,067 $ 34.02 8.29 $ — Options granted 156,000 0.99 — 115.4 Less: options forfeited — — — — Less: options expired/cancelled (5,000) 33.40 — — Less: options exercised — — — — Options outstanding at September 30, 2023 210,067 $ 9.51 8.99 $ 115.4 Options exercisable at September 30, 2023 54,067 $ 34.08 7.48 $ — The following is a summary of RSU’s for the nine months ended September 30, 2023 and for the year ended December 31, 2022: Weighted-Average Weighted- Remaining Number of Average Contractual Shares Fair Value at Grant Date Term (Years) RSU’s outstanding at December 31, 2022 40,238 $ 16.87 9.20 RSU’s granted — — — Less: RSU’s forfeited — — — Less: RSU’s expired/cancelled (5) 11.90 — Less: RSU’s vested (40,233) 16.88 — RSU’s outstanding at September 30, 2023 — $ — — On January 4, 2022, pursuant to a consulting agreement, the Company awarded a grant of 5,000 options to purchase shares of common stock of the Company at an exercise price of $33.40 per share. The shares of common stock underlying the options vested 100% upon issuance. These options were canceled pursuant to the cancellation of this consulting agreement, during April 2023. On April 7, 2022, the Company awarded the four Directors grants of 24,876 total RSU’s with a stock price of $11.90 per share. The RSU’s shall vest 100% on the one-year anniversary of the date of grant. Also on April 7, 2022, Tania King, an employee of Juggernaut Capital Partners LLP, pursuant to her contract, was granted 6,051 RSUs with a stock price of $11.90 per share. The RSU’s vested 100% on the one-year anniversary of the date of grant. On April 10, 2023, the Company awarded each of the four Directors a grant of 39,000 options to purchase shares of common stock of the Company at an exercise price of $0.99 per share. The shares of common stock underlying the options will vest 100% on the one-year anniversary of the date of grant. Stock-based compensation expense recognized for the nine months ended September 30, 2023 and 2022 was $204,492 and $966,231, respectively, and is recorded in general and administrative expenses in the consolidated statements of operations. |
Common Stock Warrants
Common Stock Warrants | 9 Months Ended |
Sep. 30, 2023 | |
Common Stock Warrants | |
Common Stock Warrants | 11) Common Stock Warrants As of September 30, 2023, the Company’s warrants by expiration date were as follows: Number of Warrants Exercise Price (in Dollars) Expiration Date 278 $ 16.00 August 23, 2023 2,279 356.50 June 1, 2024 7,492 218.50 June 17, 2024 1,997 312.50 June 19, 2024 2,279 265.50 September 1, 2024 1,050 127.40 September 16, 2024 2,279 43.00 December 1, 2024 2,800 56.50 March 2, 2025 2,800 73.00 June 1, 2025 2,800 55.00 September 1, 2025 2,800 47.05 December 1, 2025 222,189 75.00 December 1, 2025 90,880 175.00 December 1, 2025 62,429 512.50 December 1, 2025 15,856 1,250.00 December 1, 2025 175,132 17.15 October 18, 2026 233,775 35.00 December 12, 2026 175,000 35.00 December 27, 2026 7,200,002 2.25 July 17, 2028 8,204,117 Number of Warrants Warrants outstanding - January 1, 2022 1,004,115 Warrants issued in 2022 — Warrants outstanding - December 31, 2022 1,004,115 Warrants issued - Nine Months ending September 30, 2023 7,200,002 Warrants outstanding - September 30, 2023 8,204,117 On July 17, 2023, the Company issued warrants to purchase up to 7,200,002 shares of common stock in connection with the Private Placement (as defined below). The warrants have an initial exercise price of $2.25 per share of common stock and expire five years after the date of issuance. The exercise price is subject to customary adjustments for stock dividends, stock splits, reclassifications and the like, and subject to price-based adjustment, on a “full ratchet” basis, in the event of any issuances of Common Stock, or securities convertible, exercisable or exchangeable for common stock, at a price below the then-applicable exercise price (subject to certain exceptions). Upon any such price-based adjustment, the number of shares issuable upon exercise of the warrants will be increased proportionately. The warrants were determined to be within the scope of ASC 480-10 as they are puttable to the Company at Holders’ election upon the occurrence of a Fundamental Transaction (as defined in the agreements). As such, the Company recorded the warrants as a liability at fair value with subsequent changes in fair value recognized in earnings. The Company utilized the Black Scholes Model to calculate the value of these warrants issued during the three months ended September 30, 2023. The fair value of the warrants of approximately $21.5 million was estimated at the date of issuance using the following weighted average assumptions: dividend yield 0%; expected term of 5.0 years; equity volatility of 110.0%; the closing stock price on July 13, 2023 of $3.54 and a risk-free interest rate of 3.93%. Transaction costs incurred attributable to the issuance of the warrants of $2.9 million were immediately expensed in accordance with ASC 480. During the three months ended September 30, 2023, the Company recorded a gain of approximately $11.7 million related to the change in fair value of the warrant liability which is recorded in other income (expense) on the Statements of Operations. The fair value of the warrants of approximately $9.8 million was estimated at September 30, 2023 utilizing the Black Scholes Model using the following weighted average assumptions: dividend yield 0%; remaining term of 4.79 years; equity volatility of 115.0%; the closing stock price on September 30, 2023 of $1.73 and a risk-free interest rate of 4.62%. |
Basic and Diluted Net Loss per
Basic and Diluted Net Loss per Common Share | 9 Months Ended |
Sep. 30, 2023 | |
Basic and Diluted Net Loss per Common Share | |
Basic and Diluted Net Loss per Common Share | 12) Basic and Diluted Net Loss per Common Share The following is a reconciliation of the weighted average number of common shares outstanding used in calculating basic and diluted net loss per share: For the Nine Months Ended For the Three Months Ended September 30, September 30, 2023 2022 2023 2022 Numerator Net loss per common $ (8,820,570) $ (15,816,213) $ (4,888,740) $ (13,830,196) Denominator Weighted-average common shares for basic net loss per share 2,108,747 2,068,472 2,119,620 2,068,472 Basic and diluted net loss per common share $ (4.18) $ (7.65) $ (2.31) $ (6.69) The following table summarizes the potentially dilutive securities convertible into common shares that were excluded from the calculation of diluted net loss per share because their inclusion would have been antidilutive: For the Nine Months Ended For the Three Months Ended September 30, September 30, 2023 2022 2023 2022 Stock Options 210,067 59,067 210,067 59,067 RSUs — 42,564 — 42,564 Series A Convertible Preferred stock 6,762,090 — 6,762,090 — Warrants 8,204,117 1,004,115 8,204,117 1,004,115 Total 15,176,274 1,105,746 15,176,274 1,105,746 |
Marketing, Licensing and Distri
Marketing, Licensing and Distribution Agreements | 9 Months Ended |
Sep. 30, 2023 | |
Marketing, Licensing and Distribution Agreements. | |
Marketing, Licensing and Distribution Agreements | 13) Marketing, Licensing and Distribution Agreements (a) Vivus On September 30, 2016, the Company entered into a License and Commercialization Agreement (the “License Agreement”) with Vivus, Inc (“Vivus”) to purchase and receive the license for the commercialization and exploitation of Stendra® for a one-time fee of $70 million. The License Agreement gives the Company the right to sell Stendra® in the U.S and its territories, Canada, South America, and India. In December 2000, Vivus originally was granted the license from Mitsubishi Tanabe Pharma Corporation (“MTPC”) to develop, market, and manufacture Stendra®. Stendra® was approved by the Food and Drug Administration (“FDA”) in April 2012 to treat male erectile dysfunction. Under the License Agreement, the Company will pay MTPC a royalty of 5% on the first $500 million of net sales and 6% of net sales thereafter. In consideration for the trademark assignment and the use of the trademarks associated with the product and the Vivus technology, the Company shall (a) during the first, second, and third years following the expiration of the Royalty Period in a particular country in the Company’s territory, pay to Vivus a royalty equal to 2% of the net sales of products in such territory; and (b) following the fourth and fifth years following the end of the Royalty Period in such territory, pay to Vivus a royalty equal to 1% of the net sales of products in such territory. Thereafter, no further royalties shall be owed with respect to net sales of Stendra® in such territory. In addition, the Company will be responsible for a pro-rata portion of a $6 million milestone payment to be paid once $250 million in sales has been reached on the separate revenue stream of Stendra®. Should the $250 million of sales threshold be reached, the Company will be responsible for $3.2 million of the milestone payment. In connection with the License Agreement, the Company and Vivus also entered into a Supply Agreement. The Supply Agreement was terminated, effective September 30, 2021. On January 18, 2022, Petros and Vivus entered into a Settlement Agreement (the “Vivus Settlement Agreement”) related to the minimum purchase requirements under the Vivus Supply Agreement in 2018, 2019 and 2020 and certain reimbursement rights asserted by a third-party retailer in connection with quantities of the Company’s Stendra® product that were delivered to the third-party retailer and later returned. In connection with the Vivus Settlement Agreement, Petros retained approximately $7.3 million of Active Pharmaceutical Ingredient (“API”) inventory under the Vivus Supply Agreement. In exchange for the API and reduction of current liabilities after prepayment of $900,000, Petros executed an interest-bearing promissory note (the “Note”) in favor of Vivus in the original principal amount of $10,201,758, which the Company believes approximates fair value (See Note 8). In addition to the payments to be made in accordance with the Note, the Company further agreed in the Vivus Settlement Agreement to (i) grant to Vivus a right of first refusal to provide certain types of debt and convertible equity (but not preferred equity) until the Note is paid in full, and (ii) undertake to make certain regulatory submissions to effectuate Vivus’ ability to exercise its rights under the License Agreement. On January 18, 2022, the Company made a prepayment of the obligations under the Note in the amount of $900,000, and a payment of $1,542,904 with respect to a purchase order made in 2021 to Vivus. In consideration of these payments and upon the Company’s satisfaction of certain regulatory submissions, Vivus released 100% of the quantity of bulk Stendra® tablets by the end of the first quarter 2022. As a result of entering into the Vivus Settlement Agreement, the Company decreased accrued expenses by $6.5 million and decreased accrued inventory purchases by $14.2 million; which were partially offset by a decrease in API purchase commitments of $6.2 million and an increase to liabilities for the Note of $10.2 million (which is net of the $0.9 million prepayment on the Note). As a result, the Company recorded a $3.4 million gain on settlement for the year ended December 31, 2022. The Company has $1.0 million of API inventory which it has title to and is classified as raw materials inventory. The additional API inventory that the Company does not have title to is classified as API Inventory in either other current assets or other assets, depending on whether the Company expects to take title to the product within one year from the date of the financial statements. As of September 30, 2023 and December 31, 2022, there was $0.7 million and $0.7 million respectively included in other current assets (see Note 5 Prepaid and Other Current Assets). As of September 30, 2023 and December 31, 2022, there was $4.4 million and $5.1 million included as other assets on the accompanying consolidated balance sheets, respectively. The Company reviews its inventory levels and purchase commitments for excess amounts that it is required to purchase but projects it will not be able to sell prior to product expiry. The Company did not record any reserve for the three and nine months ended September 30, 2023 and 2022. During the nine months ended September 30, 2023 and 2022, the Company incurred royalties to MTPC for Stendra® of $170,822 and $135,816, respectively. Royalties incurred were included in cost of goods sold in the consolidated statements of operations. As of September 30, 2023, the Company had a payable for royalties of $46,288, which is included in accrued expenses in the accompanying consolidated balance sheets. As of December 31, 2022, the company had a receivable for royalties of $106,115, which are included in other current assets. (see Note 7 Accrued Expenses and Note 5 Prepaid and other Current Assets). The license agreement between MTPC and Vivus (“MTPC License”) contains certain termination rights that would allow MTPC to terminate the agreement if Vivus were to breach any of the terms of the MTPC License or become insolvent or bankrupt. In the event that MTPC terminates the MTPC License with Vivus because of any contractual breach the Company has step-in rights with MTPC, which would allow the Company to continue to sell Stendra (b) Patheon Following the termination of the Vivus Supply Agreement, Petros, through its subsidiary Metuchen, entered into a Technology Transfer Service Agreement on January 20, 2022 with Patheon Pharmaceuticals Inc., part of Thermo Fisher Scientific (“Patheon”), pursuant to which the Company and Patheon agreed to collaborate as strategic partners for commercial production of Stendra® tablets at Patheon’s facilities in Cincinnati, Ohio. Under the Agreement, Patheon or one of its affiliates will provide pharmaceutical development and technology transfer services in order to establish and validate its ability to manufacture supply of the Company’s Stendra® product. Any commercial sale of product manufactured during the performance of the Agreement must be subject to a subsequent commercial manufacturing services agreement (with associated quality agreement) between the parties before it can be offered for commercial sale. (c) Hybrid In March 2020, the Company acquired the exclusive license to H100™ from Hybrid. H100™ is a topical candidate with at least one active ingredient and potentially a combination of ingredients responsible for the improvement of penile curvature during the acute phase of Peyronie’s disease. The Company terminated its exclusive license to H100™ from Hybrid on May 11, 2023. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 14) Commitments and Contingencies (a) Legal Proceedings On July 14, 2020, Greg Ford, the Chief Executive Officer of the Company, was terminated. On July 14, 2020, Mr. Ford, through his attorney, claimed that he was entitled to severance pay pursuant to an employment agreement following the termination of his employment on that same date. This claim is currently at an early stage where the Company is unable to determine the likelihood of any unfavorable outcome. The Company is not currently involved in any other significant claims or legal actions that, in the opinion of management, will have a material adverse impact on the Company’s operations, financial position or cash flows. |
Segment Information
Segment Information | 9 Months Ended |
Sep. 30, 2023 | |
Segment Information | |
Segment Information | 15) Segment Information The Company manages its operations through two segments. The Company’s two segments, Prescription Medications and Medical Devices, focus on the treatment of male erectile dysfunction. The Prescription Medications segment consists primarily of operations related to Stendra®, which is sold generally in the United States. The Medical Devices segment consists primarily of operations related to vacuum erection devices, which are sold domestically and internationally. The Company separately presents the costs associated with certain corporate functions as Corporate, primarily consisting of unallocated operating expenses including costs that were not specific to a particular segment but are general to the group, expenses incurred for administrative and accounting staff, general liability and other insurance, professional fees and other similar corporate expenses. Interest and other income (expense), net is also not allocated to the operating segments. The Company’s results of operations by reportable segment for the nine months ended September 30, 2023 are summarized as follows: Prescription Medical For the Nine Months Ended September 30, 2023 Medications Devices Corporate Consolidated Net sales $ 3,416,444 $ 2,770,194 $ — $ 6,186,638 Cost of goods sold 343,109 1,129,964 — 1,473,073 Selling, general and administrative expenses 1,006,666 1,398,890 3,976,610 6,382,166 Warrant issuance costs — — 2,855,000 2,855,000 Research and development expenses 1,499,842 74,918 — 1,574,760 Depreciation and amortization expense 1,726,409 753,976 — 2,480,385 Change in fair value of derivative liability — — 430,000 430,000 Change in fair value of warrant liability — — (11,739,000) (11,739,000) Interest income — — (287,722) (287,722) Interest expense — — 410,317 410,317 Loss on issuance of Series A Preferred Stock — — 11,088,997 11,088,997 Net loss $ (1,159,582) $ (587,554) $ (6,734,202) $ (8,481,338) The Company’s results of operations by reportable segment for the nine months ended September 30, 2022 are summarized as follows: Prescription Medical For the Nine Months Ended September 30, 2022 Medications Devices Corporate Consolidated Net sales $ 2,716,311 $ 2,477,642 $ — $ 5,193,953 Cost of goods sold 525,073 883,013 — 1,408,086 Selling, general and administrative expenses 3,933,295 1,352,239 3,999,783 9,285,317 Gain on settlement of contingent liability (3,389,941) — — (3,389,941) Research and development expenses 1,428,848 133,670 — 1,562,518 Depreciation and amortization expense 3,808,991 873,619 — 4,682,610 Intangible asset impairment 7,460,000 — — 7,460,000 Change in fair value of derivative liability — — (460,000) (460,000) Interest expense 451,075 — — 451,075 Income tax expense — 10,501 — 10,501 Net loss $ (11,501,030) $ (775,400) $ (3,539,783) $ (15,816,213) The Company’s results of operations by reportable segment for the three months ended September 30, 2023 are summarized as follows: Prescription Medical For the Three Months Ended September 30, 2023 Medications Devices Corporate Consolidated Net sales $ 925,759 $ 748,898 $ — $ 1,674,657 Cost of goods sold 85,388 323,087 — 408,475 Selling, general and administrative expenses 251,674 493,447 1,256,814 2,001,935 Warrant issuance costs — — 2,855,000 2,855,000 Research and development expenses 369,505 19,588 — 389,093 Depreciation and amortization expense 575,470 251,325 — 826,795 Change in fair value of derivative liability — — 430,000 430,000 Change in fair value of warrant liability — — (11,739,000) (11,739,000) Interest income — — (168,481) (168,481) Interest expense — — 131,351 131,351 Loss on issuance of Series A Preferred Stock — — 11,088,997 11,088,997 Net loss $ (356,278) $ (338,549) $ (3,854,681) $ (4,549,508) The Company’s results of operations by reportable segment for the three months ended September 30, 2022 are summarized as follows: Prescription Medical For the Three Months Ended September 30, 2022 Medications Devices Corporate Consolidated Net sales $ (2,140,629) $ 682,897 $ — $ (1,457,732) Cost of goods sold 36,067 250,458 — 286,525 Selling, general and administrative expenses 493,128 467,700 1,210,147 2,170,975 Research and development expenses 678,552 57,364 — 735,916 Depreciation and amortization expense 1,269,664 291,206 — 1,560,870 Intangible asset impairment 7,460,000 — — 7,460,000 Interest expense 147,677 — — 147,677 Income tax expense — 10,501 — 10,501 Net loss $ (12,225,717) $ (394,332) $ (1,210,147) $ (13,830,196) The following table reflects net sales by geographic region for the three and nine months ended September 30, 2023 and 2022: For the Nine Months Ended For the Three Months Ended September 30, September 30, Net sales 2023 2022 2023 2022 United States $ 5,253,587 $ 4,260,171 $ 1,496,988 $ (1,647,367) International 933,051 933,782 177,669 189,635 $ 6,186,638 $ 5,193,953 $ 1,674,657 $ (1,457,732) No individual country other than the United States accounted for 10% of total sales for the three and nine months ended September 30, 2023 and 2022. The Company’s assets by reportable segment and reconciliation of segment assets to consolidated assets as of September 30, 2023, are summarized as follows: Prescription Medical Medications Devices Consolidated Intangible assets, net $ 5,459,960 $ 4,311,804 $ 9,771,764 Total segment assets $ 32,810,715 $ 6,103,453 $ 38,914,168 The Company’s assets by reportable segment and reconciliation of segment assets to consolidated assets as of December 31, 2022, are summarized as follows: Prescription Medical Medications Devices Consolidated Intangible assets, net $ 7,178,704 $ 5,065,780 $ 12,244,484 Total segment assets $ 25,831,048 $ 6,590,166 $ 32,421,214 |
Private Placement
Private Placement | 9 Months Ended |
Sep. 30, 2023 | |
Private placement. | |
Private Placement | 16) Private Placement On July 13, 2023, we entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain accredited investors (the “Investors”), pursuant to which we agreed to sell in a private placement to the Investors (i) an aggregate of 15,000 shares of our newly-designated Series A Convertible Preferred Stock, with a par value of $0.0001 per share and a stated value of $1,000 per share (the “Series A Preferred Stock”), initially convertible into up to 6,666,668 shares of our common stock, par value $0.0001 per share (the “Common Stock”) at an initial conversion price of $2.25 per share (the “Series A Preferred Shares”), and (ii) warrants to acquire up to an aggregate of 6,666,668 shares of Common Stock (the “Warrants”) at an initial exercise price of $2.25 per share (collectively, the “Private Placement”). Pursuant to the terms of the Certificate of Designations of Series A Convertible Preferred Stock (the “Certificate of Designations”) and the Warrants, each of the Conversion Price (as defined below) and the exercise price and the number of shares underlying the Warrants is subject to customary adjustments for stock dividends, stock splits, reclassifications and the like, and subject to price-based adjustment in the event of any issuances of Common Stock, or securities convertible, exercisable or exchangeable for Common Stock, at a price below the then-applicable Conversion Price (subject to certain exceptions). As of September 30, 2023, the Conversion Price and the exercise price of the Warrants was equal to $2.25 per share. The Private Placement was exempt from the registration requirements of the Securities Act pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D of the Securities Act and in reliance on similar exemptions under applicable state laws. The closing of the Private Placement occurred on July 17, 2023. The aggregate gross proceeds from the Private Placement was approximately $15 million. We intend to use the net proceeds from the Private Placement for general corporate purposes. We engaged Katalyst Securities LLC (the “Placement Agent”) to act as exclusive placement agent in connection with the Private Placement. Pursuant to an Engagement Letter with the Placement Agent, we paid to the Placement Agent or its designees (i) a cash fee equal to 8% of the gross proceeds of the Private Placement and (ii) warrants to acquire up to an aggregate of 533,334 shares of Common Stock on the same terms as the Warrants. Series A Preferred Stock The terms of the Series A Preferred Shares are as set forth in the form of Certificate of Designations. The Series A Preferred Shares will be convertible into shares of Common Stock (the “Conversion Shares”) at the election of the holder at any time at an initial conversion price of $2.25 (the “Conversion Price”). The Conversion Price is subject to customary adjustments for stock dividends, stock splits, reclassifications and the like, and subject to price-based adjustment in the event of any issuances of Common Stock, or securities convertible, exercisable or exchangeable for Common Stock, at a price below the then-applicable Conversion Price (subject to certain exceptions). We are required to redeem the Series A Preferred Shares in 13 equal monthly installments, commencing on November Stock during the thirty 20 The holders of the Series A Preferred Shares are entitled to dividends of 8% per annum, compounded monthly, which are payable, at our option, in cash or shares of Common Stock, or in a combination thereof, in accordance with the terms of the Certificate of Designations. On September 29, 2023, we filed an amendment to the Certificate of Designations with the Secretary of State for the State of Delaware, pursuant to which the terms of the Series A Preferred Stock were amended to permit certain additional procedures for the payment of redemptions and conversions Upon the occurrence and during the continuance of a Triggering Event (as defined in the Certificate of Designations), the Series A Preferred Shares will accrue dividends at the rate of 15% per annum. In connection with a Triggering Event, each holder of Series A Preferred Shares will be able to require us to redeem in cash any or all of the holder’s Series A Preferred Shares at a premium set forth in the Certificate of Designations. Upon conversion or redemption, the holders of the Series A Preferred Shares are also entitled to receive a dividend make-whole payment. The holders of Series A Preferred Shares have no voting rights on account of the Series A Preferred Shares, other than with respect to certain matters affecting the rights of the Series A Preferred Shares. The Series A Preferred Shares were determined to be more akin to a debt-like host than an equity-like host. The Company identified the following embedded features that are not clearly and closely related to the debt host instrument: 1) make-whole interest upon a contingent redemption event, 2) make-whole interest upon a conversion event, 3) an installment redemption upon an Equity Conditions Failure (as defined in the Certificate of Designation), and 4) variable share-settled installment conversion. These features were bundled together, assigned probabilities of being affected and measured at fair value. Subsequent changes in fair value of these features are recognized in the Condensed Consolidated Statements of Operations. The Company estimated the $6.1 million fair value of the bifurcated embedded derivative at issuance using a Monte Carlo simulation model, with the following inputs the fair value of our common stock of $3.54 on the issuance date, estimated equity volatility of 165.0%, estimated traded volume volatility of 790.0%, the time to maturity of 1.38 years, a discounted market interest rate of 8.1%, dividend rate of 8.0%, a penalty dividend rate of 15.0%, and probability of default of 9.7%. The fair value of the bifurcated derivative liability was estimated utilizing the with and without method which uses the probability weighted difference between the scenarios with the derivative and the plain vanilla maturity scenario without a derivative. The discount to the fair value is included as a reduction to the carrying value of the Series A Preferred Shares. During the three months ended September 30, 2023, the Company recorded a total discount of approximately $15.0 million upon issuance of the Series A Preferred Shares, which was comprised of the issuance date fair value of the associated embedded derivative of approximately $6.1 million and the difference between the gross proceeds and the allocated residual fair value of the Series A Preferred Shares of approximately $8.9 million. When it is deemed probable that the Series A Preferred Shares will be redeemed, the Company will accrete the Series A Preferred Shares to redemption amount pursuant to ASC 480-10-S99-3A. As the fair value of the liabilities required to be subsequently measured at fair value exceeded the net proceeds received, the Company recognized the excess of the fair value over the net proceeds received as a loss upon issuance of preferred stock of $11.1 million which is included in other income (expense) in the Condensed Consolidated Statement of Operations. During the three months ended September 30, 2023, the Company recorded a loss of approximately $0.4 million related to the change in fair value of the derivative liability which is recorded in other income (expense) on the Condensed Consolidated Statements of Operations. The Company estimated the $6.6 million fair value of the bifurcated embedded derivative at September 30, 2023 using a Monte Carlo simulation model, with the following inputs the fair value of our common stock of $1.73 on the valuation date, estimated equity volatility of 180.0%, estimated traded volume volatility of 890.0%, the time to maturity of 1.17 years, a discounted market interest rate of 7.8%, dividend rate of 8.0%, a penalty dividend rate of 15.0%, and probability of default of 10.4%. On September 29, 2023, the Company notified the investors of its intention to redeem the first installment due November 1, 2023 (the “November Installment”) in cash. At that time, the Company established a liability of $1,368,547 representing the cash payable to investors which includes $1,153,846 of the stated value of the Series A Preferred Shares, $125,170 of accrued dividends payable, and $89,531 for the cash premium for the November Installment which was recognized as a deemed dividend. As of November 14, 2023, we have redeemed 1,154 Series A Preferred Shares for cash of $1,213,132 and issued 87,499 shares of Common Stock, elected pursuant to the terms of the Certificate of Designations, worth $145,248 in relief of the First Installment liability. As of September 30, 2023, the Company has recognized $339,232 of preferred dividends which is comprised of $249,701 of preferred dividends at the stated dividend rate and $89,531 of deemed dividends for cash premium for the November Installment. We are subject to certain affirmative and negative covenants regarding the incurrence of indebtedness, the existence of liens, the repayment of indebtedness, the payment of cash in respect of dividends (other than dividends pursuant to the Certificate of Designations), distributions or redemptions, and the transfer of assets, among other matters. There is no established public trading market for the Series A Preferred Shares and we do not intend to list the Series A Preferred Shares on any national securities exchange or nationally recognized trading system. Warrants The Warrants became exercisable for shares of Common Stock (the “Warrant Shares”) immediately upon issuance, at an initial exercise price of $2.25 per share (the “Exercise Price”) and expire five years from the date of issuance. The Exercise Price is subject to customary adjustments for stock dividends, stock splits, reclassifications and the like, and subject to price-based adjustment, on a “full ratchet” basis, in the event of any issuances of Common Stock, or securities convertible, exercisable or exchangeable for Common Stock, at a price below the then-applicable Exercise Price (subject to certain exceptions). Upon any such price-based adjustment, the number of Warrant Shares issuable upon exercise of the Warrants will be increased proportionately. There is no established public trading market for the Warrants and we do not intend to list the Warrants on any national securities exchange or nationally recognized trading system. Registration Rights In connection with the Private Placement, we entered into a Registration Rights Agreement with the Investors (the “Registration Rights Agreement”), pursuant to which we agreed to file a resale registration statement (the “Registration Statement”) with the SEC to register for resale 200% of the Conversion Shares and the Warrant Shares promptly following the Closing Date, but in no event later than 30 Nasdaq Stockholder Approval Our ability to issue Conversion Shares and Warrant Shares using shares of Common Stock is subject to certain limitations set forth in the Certificate of Designations. Prior to receiving the Nasdaq Stockholder Approval, such limitations included a limit on the number of shares that may be issued until the time, if any, that our stockholders have approved the issuance of more than 19.99% of our outstanding shares of Common Stock in accordance with the rules of the Nasdaq Stock Market (the “Nasdaq Stockholder Approval”). In the Purchase Agreement we agreed to seek the Nasdaq Stockholder Approval at a meeting of stockholders, and we received the Nasdaq Stockholder Approval at a special meeting of stockholders held on September 14, 2023. Our directors and officers, who held approximately 29% of issued and our outstanding Common Stock as of the date of the Purchase Agreement, were party to a voting agreement pursuant to which, among other things, each party agreed, solely in their capacity as a stockholder, to vote all of their shares of Common Stock in favor of the approval of the Nasdaq Stockholder Approval and against any actions that could adversely affect our ability to perform our obligations under the Purchase Agreement. The voting agreement also placed certain restrictions on the transfer of the shares of Common Stock held by the signatories thereto. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 17) Fair Value Measurements Fair value measurements discussed herein are based upon certain market assumptions and pertinent information available to management as of and during the three months ended September 30, 2023. The carrying amounts of cash equivalents, accounts receivable, other current assets, other assets, accounts payable, and accrued expenses approximated their fair values as of September 30, 2023 due to their short-term nature. The fair value of the bifurcated embedded derivative related to the convertible preferred stock was estimated using a Monte Carlo simulation model, which uses as inputs the fair value of our common stock and estimates for the equity volatility and traded volume volatility of our common stock, the time to maturity of the convertible preferred stock, the risk-free interest rate for a period that approximates the time to maturity, dividend rate, a penalty dividend rate, and our probability of default. The fair value of the warrant liability was estimated using the Black Scholes Model which uses as inputs the following weighted average assumptions: dividend yield, expected term in years; equity volatility; the stock price and risk-free interest rate. Fair Value on a Recurring Basis The Company follows the guidance in ASC 820 for its financial assets and liabilities that are re-measured and reported at fair value at each reporting period, and non-financial assets and liabilities that are re-measured and reported at fair value at least annually. The estimated fair value of the warrant liability and bifurcated embedded derivatives represent Level 3 measurements. The following table presents information about the Company’s liabilities that are measured at fair value on a recurring basis at September 30, 2023, and indicates the fair value hierarchy of the valuation inputs the Company utilized to determine such fair value: September 30 Description Level 2023 Liabilities: Warrant liability 3 $ 9,805,000 Bifurcated embedded derivative liability 3 $ 6,570,000 The following table sets forth a summary of the change in the fair value of the warrant liability that is measured at fair value on a recurring basis: Balance on December 31, 2022 $ — Issuance of warrants reported at fair value 21,544,000 Change in fair value of warrant liability (11,739,000) Balance on September 30, 2023 $ 9,805,000 The following table sets forth a summary of the change in the fair value of the bifurcated embedded derivative liability that is measured at fair value on a recurring basis: Balance on December 31, 2022 $ — Issuance of convertible preferred stock with bifurcated embedded derivative 6,140,000 Change in fair value of bifurcated embedded derivative 430,000 Balance on September 30, 2023 $ 6,570,000 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Summary of Significant Accounting Policies | |
Use of Estimates | Use of Estimates The preparation of Consolidated Financial Statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosures of contingent assets and liabilities at the date of the Consolidated Financial Statements and reported amounts of revenue and expenses during the reporting periods. Such estimates include the adequacy of accounts receivable reserves, return reserves, inventory reserves, assessment of long-lived assets, including intangible asset impairment and the valuation of the derivative liability, among others. Actual results could differ from these estimates and changes in these estimates are recorded when known. |
Risks and Uncertainties | Risks and Uncertainties The Company is subject to risks common to companies in the pharmaceutical industry including, but not limited to, uncertainties related to commercialization of competitor products, regulatory approvals, dependence on key products, dependence on key customers and suppliers, Stendra(R) OTC approval, and protection of intellectual property rights. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that subject the Company to concentrations of credit risk includes cash. The Company maintains cash on deposit at U.S.-based banks in amounts which, at times, exceed insured limits. |
Segment Reporting | Segment Reporting Operating segments are components of a Company for which separate financial information is available and evaluated regularly by the chief operating decision maker in assessing performance and deciding how to allocate resources. The Company’s two segments, Prescription Medications and Medical Devices, focus on the treatment of male erectile dysfunction. The Prescription Medications segment consists primarily of operations related to Stendra®, which is sold generally in the United States The Medical Devices segment consists primarily of operations related to vacuum erection devices, which are sold domestically and internationally. See Note 15 Segment Reporting. |
Revenue Recognition | Revenue Recognition Prescription Medication Sales The Company’s prescription medication sales consist of sales of Stendra® in the U.S. for the treatment of male erectile dysfunction. Under Accounting Standards Codification (“ASC”) Topic 606, Revenue Recognition (“Topic 606”), the Company recognizes revenue from prescription medication sales when its performance obligations with a customer has been satisfied. In the contracts with its customers, the Company has identified a single performance obligation to provide Stendra® upon receipt of a customer order. The performance obligation is satisfied at a point in time when the Company’s customers obtain control of Stendra®, which is typically upon delivery. The Company invoices its customers after Stendra® has been delivered and invoice payments are generally due within 30 to 75 days of invoice date. In determining the transaction price, a significant financing component does not exist since the timing from when the Company delivers Stendra® to when the customers pay for the product is typically less than one year. The Company records prescription medication sales net of any variable consideration, including but not limited to discounts, rebates, returns, chargebacks, and distribution fees. The Company uses the expected value method when estimating its variable consideration, unless terms are specified within contracts. The identified variable consideration is recorded as a reduction of revenue at the time revenues from sales of Stendra® are recognized. The Company recognizes revenue to the extent that it is probable that a significant revenue reversal will not occur in a future period. These estimates may differ from actual consideration received. The Company evaluates these estimates each reporting period to reflect known changes. As of September 30, 2023 and December 31, 2022, the reserves for sales deductions were $3.4 million and $3.0 million, respectively. The most significant sales deductions included in this reserve relate to returns, contract rebates, and distribution service (“DSA”) fees. Our estimates are based on factors such as our direct and indirect customers’ buying patterns and the estimated resulting contractual deduction rates, historical experience, specific known market events and estimated future trends, current contractual and statutory requirements, industry data, estimated customer inventory levels, current contract sales terms with our direct and indirect customers, and other competitive factors. Significant judgment and estimation is required in developing the foregoing and other relevant assumptions. The most significant sales deductions are further described below. Product Returns Consistent with industry practice, the Company maintains a return policy that generally allows its customers to return Stendra® and receive credit for product within six months prior to expiration date and up to one year Contract Rebates, Coupon Redemptions and DSA Fees The Company establishes contracts with wholesalers, chain stores, and indirect customers that provide for rebates, sales incentives, DSA fees and other allowances. Some customers receive rebates upon attaining established sales volumes. Direct rebates are generally rebates paid to direct purchasing customers based on a percentage applied to a direct customer’s purchases from us, including fees paid to wholesalers under our DSAs, as described below. Indirect rebates are rebates paid to indirect customers that have purchased our products from a wholesaler under a contract with us. The Company has entered into DSAs with certain of our significant wholesaler customers that obligate the wholesalers, in exchange for fees paid by us, to: (i) manage the variability of their purchases and inventory levels within specified limits based on product demand and (ii) provide us with specific services, including the provision of periodic retail demand information and current inventory levels for our pharmaceutical products held at their warehouse locations. See Note 3 Accounts Receivable, net for further discussion of these reserves. Accrued contracts were $49,499, $279,018 and $379,242 of September 30, 2023, December 31, 2022, and December 31, 2021, respectively. Medical Device Sales The Company’s medical device sales consist of domestic and international sales of men’s health products for the treatment of erectile dysfunction. The men’s health products include Vacuum Erection Devices, and VenoSeal. Under Topic 606, the Company recognizes revenue from medical device sales when its performance obligations with its customers have been satisfied. In the contracts with its customers, the Company has identified a single performance obligation to provide medical devices upon receipt of a customer order. The performance obligation is satisfied at a point in time when the Company’s customers obtain control of the medical device, which is typically upon shipment. The Company invoices its customers after the medical devices have been shipped and invoice payments are generally due within 30 days of invoice date for domestic customers and 90 days for international customers. In determining the transaction price, a significant financing component Product Returns Consistent with industry practice, the Company maintains a return policy that generally allows its customers to return medical devices and receive credit for products within 90 days of the sale. The provision for returns is based upon the Company’s estimates for future product returns and historical experience. As of September 30, 2023, December 31, 2021 and December 31, 2022, the reserves for product returns for medical devices were not significant. Contract Costs In relation to customer contracts, the Company incurs costs to fulfill a contract but does not incur costs to obtain a contract. These costs to fulfill a contract do not meet the criteria for capitalization and are expensed as incurred. As such, the Company did not have any contract assets at September 30, 2023, December 31, 2021 and December 31, 2022. Contract Liabilities Under Accounting Standards Codification Topic 606, Revenue Recognition, the Company recognizes revenue when its performance obligations with a customer has been satisfied. In the event it has not been satisfied, the Company records deferred revenue as a liability on the balance sheet. As of September 30, 2023, December 31, 2022, and December 31, 2021, deferred revenue was $0, $281,372 and $70,343 respectively. |
Fair Value Measurements | Fair Value Measurements In accordance with ASC 820 (Topic 820, Fair Value Measurements and Disclosures), we use a three-level hierarchy for fair value measurements of certain assets and liabilities for financial reporting purposes that distinguishes between market participant assumptions developed from market data obtained from outside sources (observable inputs) and our own assumptions about market participant assumptions developed from the best information available to us in the circumstances (unobservable inputs). The fair value hierarchy is divided into three levels based on the source of inputs as follows: ● Level 1 – inputs to the valuation methodology are quoted prices (unadjusted) for identical assets or liabilities in active markets; ● Level 2 – inputs to the valuation methodology include quoted prices for similar assets and liabilities in active markets, and inputs that are observable for the asset or liability other than quoted prices, either directly or indirectly including inputs in markets that are not considered to be active; and ● Level 3 – inputs to the valuation methodology are unobservable and significant to the fair value measurement. Categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. |
Intangible Assets | Intangible Assets The Company accounts for recognized intangible assets at cost. Intangible assets with finite useful lives are amortized over the useful life which the assets are expected to contribute directly or indirectly to future cash flows. Intangible assets are amortized using an accelerated method based on the pattern in which the economic benefits of the assets are consumed. The Company reviews the carrying value and useful lives of its intangible assets with definite lives whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable or the period over which they should be amortized has changed. When indicators of impairment exist, the Company determines whether the estimated undiscounted sum of the future cash flows of such assets is less than their carrying amounts. If less, an impairment loss is recognized in the amount, if any, by which the carrying amount of such assets exceeds their respective fair values. The Company evaluates the remaining useful life of each intangible asset that is being amortized during each reporting period to determine whether events and circumstances warrant a revision to the remaining period of amortization. If the estimate of the intangible asset’s remaining useful life has changed, the remaining carrying amount of the intangible asset is amortized prospectively over that revised remaining useful life. During the three months ended September 30, 2022, the Company noted that indicators of impairment existed and prepared an undiscounted cash flow analysis, which indicated, for the Stendra(R) product an impairment. The Company then prepared a discounted cash flow analysis resulting in an impairment of approximately $7.5 million. |
Derivative Financial Instruments | Derivative Financial Instruments The Company evaluates all its financial instruments to determine if such instruments contain features that qualify as embedded derivatives. Embedded derivatives must be separately measured from the host contract if all the requirements for bifurcation are met. The assessment of the conditions surrounding the bifurcation of embedded derivatives depends on the nature of the host contract. Bifurcated embedded derivatives are recognized at fair value, with changes in fair value recognized in the statement of operations each period. Bifurcated embedded derivatives are classified separately from the related host contract in the Company’s balance sheet. |
Basic and Diluted Net Loss per Common Share | Basic and Diluted Net Loss per Common Share The Company computes basic net loss per common share by dividing net loss applicable to common stockholders by the weighted average number of shares of common stocks outstanding during the period, excluding the anti-dilutive effects of stock options and warrants to purchase common stocks. The Company computes diluted net loss per common stock by dividing the net loss applicable to common stocks by the sum of the weighted-average number of common stocks outstanding during the period plus the potential dilutive effects of its convertible preferred stocks, stock options and warrants to purchase common stocks, but such items are excluded if their effect is anti-dilutive. Because the impact of these items is anti-dilutive during periods of net loss, there was no difference between the Company’s basic and diluted net loss per share of common stock for the three and nine months ended September 30, 2023 and 2022. See Note 12 Basic and Diluted Net Loss per Common Share. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In June 2016, the Financial Accounting Standard Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-13, Measurement of Credit Losses on Financial Instruments. ASU 2016-13, together with a series of subsequently issued related ASUs, has been codified in Topic 326. Topic 326 establishes new requirements for companies to estimate expected credit losses when measuring certain financial assets, including accounts receivables. The Company adopted the new guidance with its fiscal year beginning January 1, 2023. The adoption of ASC 326 did not have a material effect on the Company’s financial statements. In August 2020, the Financial Accounting Standards Board issued Accounting Standards Update (“ASU”) 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”) to simplify certain financial instruments. ASU 2020-06 eliminates the current models that require separation of beneficial conversion and cash conversion features from convertible instruments and simplifies the derivative scope exception guidance pertaining to equity classification of contracts in an entity’s own equity. The new standard also introduces additional disclosures for convertible debt and freestanding instruments that are indexed to and settled in an entity’s own equity. ASU 2020-06 amends the diluted earnings per share guidance, including the requirement to use the if-converted method for all convertible instruments. ASU 2020-06 is effective for fiscal years beginning after December 15, 2021 and should be applied on a full or modified retrospective basis. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. The Company adopted ASU 2020-06 effective July 1, 2023. The adoption of ASU 2020-06 did not have a material impact on the Company’s financial statements. |
Accounts Receivable, net (Table
Accounts Receivable, net (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accounts Receivable, net | |
Schedule of accounts receivable | September 30, December 31, December 31, 2023 2022 2021 Gross accounts receivables $ 3,713,405 $ 2,757,839 $ 3,363,827 Distribution service fees (358,661) (339,094) (371,310) Chargebacks accrual (7,375) (1,960) — Cash discount allowances (132,967) (99,671) (159,446) Allowance for doubtful accounts (239,384) (206,868) (377,685) Total accounts receivable, net $ 2,975,018 $ 2,110,246 $ 2,455,386 |
Inventories (Tables)
Inventories (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Inventories | |
Schedule of Inventories | September 30, 2023 December 31, 2022 Raw Materials $ 2,391,190 $ 1,574,683 Finished goods 109,903 240,430 Total inventory $ 2,501,093 $ 1,815,113 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Prepaid Expenses and Other Current Assets. | |
Schedule of prepaid expenses and other current assets | September 30, 2023 December 31, 2022 Prepaid insurance $ 169,588 $ 109,414 Prepaid coupon fees — 71,500 API purchase commitment asset (see Note 13) 694,314 663,984 Other prepaid expenses 65,655 333,158 Other current assets 57,563 138,226 Total prepaid expenses and other current assets $ 987,120 $ 1,316,282 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Intangible Assets | |
Schedule of intangible assets | Balance at December 31, 2021 $ 25,293,149 Amortization expense (5,588,665) Intangible Impairment (7,460,000) Balance at December 31, 2022 12,244,484 Amortization expense (2,472,720) Balance at September 30, 2023 $ 9,771,764 |
Schedule of future annual amortization related to the company's intangible assets | The future annual amortization related to the Company’s intangible assets is as follows as of September 30, 2023: 2023 (remaining 3 months) $ 800,027 2024 2,800,623 2025 1,754,328 2026 1,442,186 2027 1,212,871 Thereafter 1,761,729 Total $ 9,771,764 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accrued Expenses | |
Schedule of accrued expenses | September 30, 2023 December 31, 2022 Accrued product returns $ 2,853,413 $ 2,311,647 Accrued contract rebates 49,499 279,018 Due to 3PL/Wholesalers 103,161 155,081 Accrued bonuses 421,523 427,500 Accrued professional fees — 51,620 Other accrued expenses 441,431 409,796 Total accrued expenses $ 3,869,027 $ 3,634,662 |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Debt | |
Schedule of future principal payments of the promissory note | 2024 1,530,729 2025 2,720,940 2026 3,264,351 2027 872,073 Total $ 8,388,093 Less: current portion (1,139,458) Promissory note, net of current portion $ 7,248,635 |
Operating Leases (Tables)
Operating Leases (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies. | |
Summary of supplemental balance sheet information related to leases | As of September 30, 2023 As of December 31, 2022 Operating lease ROU asset: Other assets $ 260,849 $ 358,472 Operating lease liability: Other current liabilities 148,758 142,340 Other long-term liabilities 151,395 262,677 Total operating lease liability $ 300,153 $ 405,017 |
Summary of supplemental lease term and discount rate information related to leases | As of September 30, 2023 As of December 31, 2022 Weighted-average remaining lease terms - operating leases 1.9 years 2.7 years Weighted-average discount rate - operating leases 12.6 % 12.6 % |
Summary of supplemental cash flow information related to leases | For the Nine Months For the Three Months Ended September 30, Ended September 30, 2023 2022 2023 2022 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 141,677 $ 140,805 $ 47,226 $ 46,935 |
Summary of future minimum lease payments under non-cancelable leases | Future minimum lease payments under non-cancelable leases as of September 30, 2023, were as follows: Lease Liability Maturity Analysis Operating Leases 2023 (remaining 3 months) $ 47,697 2024 155,242 2025 81,107 2026 82,324 Thereafter — Total lease payments 366,370 Less: Imputed Interest (66,217) Total $ 300,153 |
Schedule of future minimum sublease income under non-cancelable leases | Future minimum sublease income under non-cancelable leases as of September 30, 2023, were as follows: Sublease income Operating Leases 2023 (remaining 3 months) 21,000 2024 56,000 Total $ 77,000 |
Stock Options and Restricted _2
Stock Options and Restricted Stock Units ("RSU's") (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Stock Options and Restricted Stock Units ("RSU's") | |
Schedule of stock options | Weighted-Average Weighted- Remaining Aggregate Intrinsic Number of Average Contractual Value Shares Exercise Price Term (Years) ($ in thousands) Options outstanding at December 31, 2022 59,067 $ 34.02 8.29 $ — Options granted 156,000 0.99 — 115.4 Less: options forfeited — — — — Less: options expired/cancelled (5,000) 33.40 — — Less: options exercised — — — — Options outstanding at September 30, 2023 210,067 $ 9.51 8.99 $ 115.4 Options exercisable at September 30, 2023 54,067 $ 34.08 7.48 $ — Weighted-Average Weighted- Remaining Number of Average Contractual Shares Fair Value at Grant Date Term (Years) RSU’s outstanding at December 31, 2022 40,238 $ 16.87 9.20 RSU’s granted — — — Less: RSU’s forfeited — — — Less: RSU’s expired/cancelled (5) 11.90 — Less: RSU’s vested (40,233) 16.88 — RSU’s outstanding at September 30, 2023 — $ — — |
Common Stock Warrants (Tables)
Common Stock Warrants (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Common Stock Warrants | |
Schedule of warrants by expiration date | As of September 30, 2023, the Company’s warrants by expiration date were as follows: Number of Warrants Exercise Price (in Dollars) Expiration Date 278 $ 16.00 August 23, 2023 2,279 356.50 June 1, 2024 7,492 218.50 June 17, 2024 1,997 312.50 June 19, 2024 2,279 265.50 September 1, 2024 1,050 127.40 September 16, 2024 2,279 43.00 December 1, 2024 2,800 56.50 March 2, 2025 2,800 73.00 June 1, 2025 2,800 55.00 September 1, 2025 2,800 47.05 December 1, 2025 222,189 75.00 December 1, 2025 90,880 175.00 December 1, 2025 62,429 512.50 December 1, 2025 15,856 1,250.00 December 1, 2025 175,132 17.15 October 18, 2026 233,775 35.00 December 12, 2026 175,000 35.00 December 27, 2026 7,200,002 2.25 July 17, 2028 8,204,117 |
Schedule of warrants | Number of Warrants Warrants outstanding - January 1, 2022 1,004,115 Warrants issued in 2022 — Warrants outstanding - December 31, 2022 1,004,115 Warrants issued - Nine Months ending September 30, 2023 7,200,002 Warrants outstanding - September 30, 2023 8,204,117 |
Basic and Diluted Net Loss pe_2
Basic and Diluted Net Loss per Common Share (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Basic and Diluted Net Loss per Common Share | |
Summary of basic and diluted net loss per share | For the Nine Months Ended For the Three Months Ended September 30, September 30, 2023 2022 2023 2022 Numerator Net loss per common $ (8,820,570) $ (15,816,213) $ (4,888,740) $ (13,830,196) Denominator Weighted-average common shares for basic net loss per share 2,108,747 2,068,472 2,119,620 2,068,472 Basic and diluted net loss per common share $ (4.18) $ (7.65) $ (2.31) $ (6.69) |
Summary of potentially dilutive securities convertible into common shares | For the Nine Months Ended For the Three Months Ended September 30, September 30, 2023 2022 2023 2022 Stock Options 210,067 59,067 210,067 59,067 RSUs — 42,564 — 42,564 Series A Convertible Preferred stock 6,762,090 — 6,762,090 — Warrants 8,204,117 1,004,115 8,204,117 1,004,115 Total 15,176,274 1,105,746 15,176,274 1,105,746 |
Segment Information (Tables)
Segment Information (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Segment Information | |
Summary of results of operations by reportable segment | Prescription Medical For the Nine Months Ended September 30, 2023 Medications Devices Corporate Consolidated Net sales $ 3,416,444 $ 2,770,194 $ — $ 6,186,638 Cost of goods sold 343,109 1,129,964 — 1,473,073 Selling, general and administrative expenses 1,006,666 1,398,890 3,976,610 6,382,166 Warrant issuance costs — — 2,855,000 2,855,000 Research and development expenses 1,499,842 74,918 — 1,574,760 Depreciation and amortization expense 1,726,409 753,976 — 2,480,385 Change in fair value of derivative liability — — 430,000 430,000 Change in fair value of warrant liability — — (11,739,000) (11,739,000) Interest income — — (287,722) (287,722) Interest expense — — 410,317 410,317 Loss on issuance of Series A Preferred Stock — — 11,088,997 11,088,997 Net loss $ (1,159,582) $ (587,554) $ (6,734,202) $ (8,481,338) Prescription Medical For the Nine Months Ended September 30, 2022 Medications Devices Corporate Consolidated Net sales $ 2,716,311 $ 2,477,642 $ — $ 5,193,953 Cost of goods sold 525,073 883,013 — 1,408,086 Selling, general and administrative expenses 3,933,295 1,352,239 3,999,783 9,285,317 Gain on settlement of contingent liability (3,389,941) — — (3,389,941) Research and development expenses 1,428,848 133,670 — 1,562,518 Depreciation and amortization expense 3,808,991 873,619 — 4,682,610 Intangible asset impairment 7,460,000 — — 7,460,000 Change in fair value of derivative liability — — (460,000) (460,000) Interest expense 451,075 — — 451,075 Income tax expense — 10,501 — 10,501 Net loss $ (11,501,030) $ (775,400) $ (3,539,783) $ (15,816,213) Prescription Medical For the Three Months Ended September 30, 2023 Medications Devices Corporate Consolidated Net sales $ 925,759 $ 748,898 $ — $ 1,674,657 Cost of goods sold 85,388 323,087 — 408,475 Selling, general and administrative expenses 251,674 493,447 1,256,814 2,001,935 Warrant issuance costs — — 2,855,000 2,855,000 Research and development expenses 369,505 19,588 — 389,093 Depreciation and amortization expense 575,470 251,325 — 826,795 Change in fair value of derivative liability — — 430,000 430,000 Change in fair value of warrant liability — — (11,739,000) (11,739,000) Interest income — — (168,481) (168,481) Interest expense — — 131,351 131,351 Loss on issuance of Series A Preferred Stock — — 11,088,997 11,088,997 Net loss $ (356,278) $ (338,549) $ (3,854,681) $ (4,549,508) Prescription Medical For the Three Months Ended September 30, 2022 Medications Devices Corporate Consolidated Net sales $ (2,140,629) $ 682,897 $ — $ (1,457,732) Cost of goods sold 36,067 250,458 — 286,525 Selling, general and administrative expenses 493,128 467,700 1,210,147 2,170,975 Research and development expenses 678,552 57,364 — 735,916 Depreciation and amortization expense 1,269,664 291,206 — 1,560,870 Intangible asset impairment 7,460,000 — — 7,460,000 Interest expense 147,677 — — 147,677 Income tax expense — 10,501 — 10,501 Net loss $ (12,225,717) $ (394,332) $ (1,210,147) $ (13,830,196) |
Summary of net sales by geographic region | For the Nine Months Ended For the Three Months Ended September 30, September 30, Net sales 2023 2022 2023 2022 United States $ 5,253,587 $ 4,260,171 $ 1,496,988 $ (1,647,367) International 933,051 933,782 177,669 189,635 $ 6,186,638 $ 5,193,953 $ 1,674,657 $ (1,457,732) |
Summary of assets by reportable segment and reconciliation of segment assets to consolidated assets | The Company’s assets by reportable segment and reconciliation of segment assets to consolidated assets as of September 30, 2023, are summarized as follows: Prescription Medical Medications Devices Consolidated Intangible assets, net $ 5,459,960 $ 4,311,804 $ 9,771,764 Total segment assets $ 32,810,715 $ 6,103,453 $ 38,914,168 The Company’s assets by reportable segment and reconciliation of segment assets to consolidated assets as of December 31, 2022, are summarized as follows: Prescription Medical Medications Devices Consolidated Intangible assets, net $ 7,178,704 $ 5,065,780 $ 12,244,484 Total segment assets $ 25,831,048 $ 6,590,166 $ 32,421,214 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of fair value of financial liabilities on recurring basis | September 30 Description Level 2023 Liabilities: Warrant liability 3 $ 9,805,000 Bifurcated embedded derivative liability 3 $ 6,570,000 The following table sets forth a summary of the change in the fair value of the warrant liability that is measured at fair value on a recurring basis: Balance on December 31, 2022 $ — Issuance of warrants reported at fair value 21,544,000 Change in fair value of warrant liability (11,739,000) Balance on September 30, 2023 $ 9,805,000 |
summary of the change in the fair value of financial liabilities | Balance on December 31, 2022 $ — Issuance of convertible preferred stock with bifurcated embedded derivative 6,140,000 Change in fair value of bifurcated embedded derivative 430,000 Balance on September 30, 2023 $ 6,570,000 |
Nature of Operations, Basis o_2
Nature of Operations, Basis of Presentation, Liquidity and Going Concern (Details) - USD ($) | 1 Months Ended | 9 Months Ended | |
Jul. 31, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | |
Nature of Operations, Basis of Presentation, Liquidity and Going Concern | |||
Cash | $ 18,000,000 | ||
Working capital | 16,400,000 | ||
Accumulated deficit | (99,207,731) | $ (90,726,393) | |
Proceeds from gross proceeds | $ 15,000,000 | $ 15,000,003 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Summary of Significant Accounting Policies | |||||
Reserves for product returns | $ 2,900,000 | $ 2,300,000 | $ 3,800,000 | ||
Increase in estimates of reserve | 1,300,000 | $ 7,600,000 | |||
Accrued contract rebates | $ 49,499 | 279,018 | 379,242 | ||
Revenue practical expedient, financing component | true | ||||
Deferred Revenue | $ 0 | 281,372 | $ 70,343 | ||
Impairment charge of approximate | $ 7,460,000 | $ 7,460,000 | 7,460,000 | ||
Prescription Medications | |||||
Summary of Significant Accounting Policies | |||||
Reserves for sales deductions | $ 3,400,000 | $ 3,000,000 | |||
Medical Devices | |||||
Summary of Significant Accounting Policies | |||||
Right to return and receive credit for product | 90 days | ||||
Minimum | Prescription Medications | |||||
Summary of Significant Accounting Policies | |||||
Due period for invoice payments | 30 days | ||||
Right to return and receive credit for product | 6 months | ||||
Minimum | Medical Devices | Domestic customers | |||||
Summary of Significant Accounting Policies | |||||
Due period for invoice payments | 30 days | ||||
Maximum | Prescription Medications | |||||
Summary of Significant Accounting Policies | |||||
Due period for invoice payments | 75 days | ||||
Right to return and receive credit for product | 1 year | ||||
Maximum | Medical Devices | International customers | |||||
Summary of Significant Accounting Policies | |||||
Due period for invoice payments | 90 days |
Accounts Receivable, net (Detai
Accounts Receivable, net (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Accounts Receivable, net | |||
Gross accounts receivables | $ 3,713,405 | $ 2,757,839 | $ 3,363,827 |
Distribution service fees | (358,661) | (339,094) | (371,310) |
Chargebacks accrual | (7,375) | (1,960) | |
Cash discount allowances | (132,967) | (99,671) | (159,446) |
Allowance for doubtful accounts | (239,384) | (206,868) | (377,685) |
Total accounts receivable, net | $ 2,975,018 | $ 2,110,246 | $ 2,455,386 |
Accounts Receivable, net - Addi
Accounts Receivable, net - Additional information (Details) - customer | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Gross billings from customers | Customer concentration risk | |||
Accounts Receivable, net | |||
Number of customers | 3 | 4 | |
Gross billings from customers | Customer concentration risk | One customers | |||
Accounts Receivable, net | |||
Concentration risk percentage | 23% | 27% | |
Gross billings from customers | Customer concentration risk | Two customers | |||
Accounts Receivable, net | |||
Concentration risk percentage | 19% | 22% | |
Gross billings from customers | Customer concentration risk | Three customers | |||
Accounts Receivable, net | |||
Concentration risk percentage | 17% | 18% | |
Gross billings from customers | Customer concentration risk | Four customers | |||
Accounts Receivable, net | |||
Concentration risk percentage | 15% | ||
Account receivables | Credit concentration risk | |||
Accounts Receivable, net | |||
Number of customers | 3 | 2 | |
Account receivables | Credit concentration risk | One customers | |||
Accounts Receivable, net | |||
Concentration risk percentage | 43% | 43% | |
Account receivables | Credit concentration risk | Two customers | |||
Accounts Receivable, net | |||
Concentration risk percentage | 25% | 16% | |
Account receivables | Credit concentration risk | Three customers | |||
Accounts Receivable, net | |||
Concentration risk percentage | 14% |
Inventories (Details)
Inventories (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Inventories | ||
Raw Materials | $ 2,391,190 | $ 1,574,683 |
Finished goods | 109,903 | 240,430 |
Total inventory | $ 2,501,093 | $ 1,815,113 |
Inventories - Additional Inform
Inventories - Additional Information (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Inventories | ||
Finished goods are net of valuation reserves | $ 405,495 | $ 364,300 |
Raw materials are net of valuation reserves | $ 2,872,977 | $ 2,872,977 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Prepaid Expenses and Other Current Assets. | ||
Prepaid insurance | $ 169,588 | $ 109,414 |
Prepaid coupon fees | 71,500 | |
API purchase commitment asset | 694,314 | 663,984 |
Other prepaid expenses | 65,655 | 333,158 |
Other current assets | 57,563 | 138,226 |
Total prepaid expenses and other current assets | $ 987,120 | $ 1,316,282 |
Intangible Assets (Details)
Intangible Assets (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Intangible Assets | ||||
Balance | $ 12,244,484 | $ 25,293,149 | $ 25,293,149 | |
Amortization expense | (2,472,720) | (5,588,665) | ||
Intangible Impairment | $ (7,460,000) | $ (7,460,000) | (7,460,000) | |
Balance | $ 9,771,764 | $ 12,244,484 |
Intangible Assets - Future annu
Intangible Assets - Future annual amortization (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Intangible Assets | |||
2023 (remaining 3 months) | $ 800,027 | ||
2024 | 2,800,623 | ||
2025 | 1,754,328 | ||
2026 | 1,442,186 | ||
2027 | 1,212,871 | ||
Thereafter | 1,761,729 | ||
Total | $ 9,771,764 | $ 12,244,484 | $ 25,293,149 |
Intangible Assets - Additional
Intangible Assets - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2022 | Dec. 31, 2022 | Sep. 30, 2023 | Dec. 31, 2021 | |
Intangible Assets | |||||
Carrying value of intangible assets | $ 12,244,484 | $ 9,771,764 | $ 25,293,149 | ||
Impairment charge of approximate | $ 7,460,000 | $ 7,460,000 | 7,460,000 | ||
Stendra product | |||||
Intangible Assets | |||||
Estimated useful lives of intangible assets | 10 years | ||||
Carrying value of intangible assets | 7,200,000 | $ 5,500,000 | |||
Impairment charge of approximate | 7,500,000 | ||||
Timm Medical product | |||||
Intangible Assets | |||||
Estimated useful lives of intangible assets | 12 years | ||||
Carrying value of intangible assets | 4,000,000 | $ 3,400,000 | |||
PTV product | |||||
Intangible Assets | |||||
Estimated useful lives of intangible assets | 12 years | ||||
Carrying value of intangible assets | $ 1,100,000 | $ 900,000 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Accrued Expenses | ||
Accrued product returns | $ 2,853,413 | $ 2,311,647 |
Accrued contract rebates | 49,499 | 279,018 |
Due to 3PL/Wholesalers | 103,161 | 155,081 |
Accrued bonuses | 421,523 | 427,500 |
Accrued professional fees | 51,620 | |
Other accrued expenses | 441,431 | 409,796 |
Total accrued expenses | $ 3,869,027 | $ 3,634,662 |
Debt - Promissory Note (Details
Debt - Promissory Note (Details) - Note | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Debt Instrument | |
Principal amount of notes payable | $ 10,201,758 |
Interest rate (in percent) | 6% |
Interest rate at the time of default (in percent) | 9% |
Debt - Future minimum principal
Debt - Future minimum principal payments (Details) - Promissory note | Sep. 30, 2023 USD ($) |
Debt Instrument | |
2024 | $ 1,530,729 |
2025 | 2,720,940 |
2026 | 3,264,351 |
2027 | 872,073 |
Total | 8,388,093 |
Less: current portion | (1,139,458) |
Promissory note, net of current portion | $ 7,248,635 |
Operating Leases - (Details)
Operating Leases - (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2023 | Jan. 10, 2022 | |
Operating Leases | ||
Security deposit received for sublease | $ 14,000 | |
Operating lease expense per month | $ 7,000 | |
Minimum | ||
Operating Leases | ||
Remaining lease terms | 10 months 24 days | |
Maximum | ||
Operating Leases | ||
Remaining lease terms | 3 years 3 months 18 days |
Operating Leases - Lease expens
Operating Leases - Lease expense (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Operating Lease Cost: | ||||
Fixed lease cost | $ 44,812 | $ 44,812 | $ 134,435 | $ 134,435 |
Amount of fixed lease cost which are offset by sublease income | $ 21,000 | $ 63,000 |
Operating Leases - Supplemental
Operating Leases - Supplemental balance sheet information related to leases (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Supplemental balance sheet information related to leases | ||
Operating lease ROU asset: | $ 260,849 | $ 358,472 |
Other assets | Prepaid expenses and other current assets | Prepaid expenses and other current assets |
Operating lease liability: | ||
Operating lease liability, current | $ 148,758 | $ 142,340 |
Other current liabilities | Other current liabilities | Other current liabilities |
Operating lease liability, noncurrent | $ 151,395 | $ 262,677 |
Other long-term liabilities | Other long-term liabilities | Other long-term liabilities |
Total | $ 300,153 | $ 405,017 |
Operating Leases - Supplement_2
Operating Leases - Supplemental lease term and discount rate information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Operating Leases | |||||
Weighted-average remaining lease terms - operating leases | 1 year 10 months 24 days | 1 year 10 months 24 days | 2 years 8 months 12 days | ||
Weighted-average discount rate - operating leases | 12.60% | 12.60% | 12.60% | ||
Cash paid for amounts included in the measurement of lease liabilities: | |||||
Operating cash flows from operating leases | $ 47,226 | $ 46,935 | $ 141,677 | $ 140,805 |
Operating Leases - Future minim
Operating Leases - Future minimum lease payments under non-cancelable leases (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Lease Liability Maturity Analysis | ||
2023 (remaining 3 months) | $ 47,697 | |
2024 | 155,242 | |
2025 | 81,107 | |
2026 | 82,324 | |
Total lease payments | 366,370 | |
Less: Imputed Interest | (66,217) | |
Total | $ 300,153 | $ 405,017 |
Operating Leases - Future min_2
Operating Leases - Future minimum sublease income under non-cancelable leases (Details) | Sep. 30, 2023 USD ($) |
Sublease income | |
2023 (remaining 3 months) | $ 21,000 |
2024 | 56,000 |
Total | $ 77,000 |
Operating Leases - Additional i
Operating Leases - Additional information (Details) | Sep. 30, 2023 USD ($) |
Operating Leases | |
Operating leases that had not yet commenced | $ 0 |
Stock Options and Restricted _3
Stock Options and Restricted Stock Units ("RSU's") (Details) - shares | Sep. 14, 2023 | Dec. 22, 2021 | Sep. 30, 2023 |
Stock Options and Restricted Stock Units ("RSU's") | |||
Number of shares authorized | 2,760,000 | ||
Number of shares available for issuance | 2,760,000 | 260,000 | 2,507,369 |
Number of shares increased for issuance | 2,500,000 | 152,166 |
Stock Options and Restricted _4
Stock Options and Restricted Stock Units ("RSU's") - Summary of stock options (Details) - USD ($) | 9 Months Ended | 12 Months Ended | ||
Apr. 07, 2022 | Jan. 04, 2022 | Sep. 30, 2023 | Dec. 31, 2022 | |
Number of Shares | ||||
Options outstanding and exercisable on beginning | 59,067 | |||
Options granted | 5,000 | 156,000 | ||
Less: options and RSU's expired/cancelled | (5,000) | |||
Options and RSU's outstanding at the end | 210,067 | 59,067 | ||
Options and RSU's exercisable at the end | 54,067 | |||
Weighted-Average Fair Value at Grant Date | ||||
Options outstanding and exercisable at the beginning (in dollars per share) | $ 34.02 | |||
Options granted (in dollars per share) | $ 33.40 | 0.99 | ||
Less: options expired/cancelled (in dollars per share) | 33.40 | |||
Options outstanding at the end (in dollars per share) | 9.51 | $ 34.02 | ||
Options exercisable at the end (in dollars per share) | $ 34.08 | |||
Weighted-Average Remaining Contractual Term (Years) and Aggregate Intrinsic Value | ||||
Options and RSU's outstanding at the beginning (in years) | 8 years 11 months 26 days | 8 years 3 months 14 days | ||
Options outstanding and exercisable at the beginning (in dollars) | $ 115,400 | |||
Options granted | $ 115,400 | |||
Options and RSU's outstanding at the ending (in years) | 8 years 11 months 26 days | 8 years 3 months 14 days | ||
Options exercisable at the end (in years) | 7 years 5 months 23 days | |||
Options outstanding at the end (in dollars) | $ 115,400 | |||
Restricted Stock Units | ||||
Number of Shares | ||||
Options outstanding and exercisable on beginning | 40,238 | |||
Options granted | 24,876 | |||
Less: options and RSU's expired/cancelled | (5) | |||
Less: RSU's vested | (40,233) | |||
Options and RSU's outstanding at the end | 40,238 | |||
Weighted-Average Fair Value at Grant Date | ||||
Options outstanding and exercisable at the beginning (in dollars per share) | $ 16.87 | |||
Options granted (in dollars per share) | $ 11.90 | |||
Less: options expired/cancelled (in dollars per share) | 11.90 | |||
Less: RSU's vested | $ 16.88 | |||
Options outstanding at the end (in dollars per share) | $ 16.87 | |||
Weighted-Average Remaining Contractual Term (Years) and Aggregate Intrinsic Value | ||||
Options and RSU's outstanding at the beginning (in years) | 0 years | 9 years 2 months 12 days | ||
Options and RSU's outstanding at the ending (in years) | 0 years | 9 years 2 months 12 days |
Stock Options and Restricted _5
Stock Options and Restricted Stock Units ("RSU's") - Additional Information (Details) | 9 Months Ended | ||||
Apr. 10, 2023 director $ / shares shares | Apr. 07, 2022 director $ / shares shares | Jan. 04, 2022 $ / shares shares | Sep. 30, 2023 USD ($) $ / shares shares | Sep. 30, 2022 USD ($) | |
Share-based Compensation Arrangement by Share-based Payment Award | |||||
Number of directors to whom option is granted | director | 4 | ||||
Number of options granted | shares | 5,000 | 156,000 | |||
Exercise price | $ / shares | $ 33.40 | $ 0.99 | |||
Vesting percentage | 100% | 100% | |||
Vesting period | 1 year | ||||
Options to purchase shares of common stock | shares | 39,000 | ||||
Options to exercise price of common stock | $ / shares | $ 0.99 | ||||
Stock-based compensation expense | $ | $ 204,492 | $ 966,231 | |||
Restricted Stock Units | |||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||
Number of directors to whom option is granted | director | 4 | ||||
Number of options granted | shares | 24,876 | ||||
Exercise price | $ / shares | $ 11.90 | ||||
Vesting percentage | 100% | ||||
Vesting period | 1 year | ||||
Tania King | Restricted Stock Units | |||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||
Number of options granted | shares | 6,051 | ||||
Exercise price | $ / shares | $ 11.90 | ||||
Vesting percentage | 100% | ||||
Vesting period | 1 year |
Common Stock Warrants - Company
Common Stock Warrants - Company's warrants by expiration date (Details) - $ / shares | Sep. 30, 2023 | Jul. 13, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Class of Warrant or Right | ||||
Number of Warrants | 8,204,117 | 1,004,115 | 1,004,115 | |
Exercise Price | $ 2.25 | |||
Expiration Date of August 23, 2023 | ||||
Class of Warrant or Right | ||||
Number of Warrants | 278 | |||
Exercise Price | $ 16 | |||
Expiration Date of June 1, 2024 | ||||
Class of Warrant or Right | ||||
Number of Warrants | 2,279 | |||
Exercise Price | $ 356.50 | |||
Expiration Date of June 17, 2024 | ||||
Class of Warrant or Right | ||||
Number of Warrants | 7,492 | |||
Exercise Price | $ 218.50 | |||
Expiration Date of June 19, 2024 | ||||
Class of Warrant or Right | ||||
Number of Warrants | 1,997 | |||
Exercise Price | $ 312.50 | |||
Expiration Date of September 1, 2024 | ||||
Class of Warrant or Right | ||||
Number of Warrants | 2,279 | |||
Exercise Price | $ 265.50 | |||
Expiration Date of September 16, 2024 | ||||
Class of Warrant or Right | ||||
Number of Warrants | 1,050 | |||
Exercise Price | $ 127.40 | |||
Expiration Date of December 1, 2024 | ||||
Class of Warrant or Right | ||||
Number of Warrants | 2,279 | |||
Exercise Price | $ 43 | |||
Expiration Date of March 2, 2025 | ||||
Class of Warrant or Right | ||||
Number of Warrants | 2,800 | |||
Exercise Price | $ 56.50 | |||
Expiration Date of June 1, 2025 | ||||
Class of Warrant or Right | ||||
Number of Warrants | 2,800 | |||
Exercise Price | $ 73 | |||
Expiration Date of September 1, 2025 | ||||
Class of Warrant or Right | ||||
Number of Warrants | 2,800 | |||
Exercise Price | $ 55 | |||
Expiration Date of December 1, 2025, One | ||||
Class of Warrant or Right | ||||
Number of Warrants | 2,800 | |||
Exercise Price | $ 47.05 | |||
Expiration Date of December 1, 2025, Two | ||||
Class of Warrant or Right | ||||
Number of Warrants | 222,189 | |||
Exercise Price | $ 75 | |||
Expiration Date of December 1, 2025, Three | ||||
Class of Warrant or Right | ||||
Number of Warrants | 90,880 | |||
Exercise Price | $ 175 | |||
Expiration Date of December 1, 2025, Four | ||||
Class of Warrant or Right | ||||
Number of Warrants | 62,429 | |||
Exercise Price | $ 512.50 | |||
Expiration Date of December 1, 2025, Five | ||||
Class of Warrant or Right | ||||
Number of Warrants | 15,856 | |||
Exercise Price | $ 1,250 | |||
Expiration Date of October 18, 2026 | ||||
Class of Warrant or Right | ||||
Number of Warrants | 175,132 | |||
Exercise Price | $ 17.15 | |||
Expiration Date of December 12, 2026 | ||||
Class of Warrant or Right | ||||
Number of Warrants | 233,775 | |||
Exercise Price | $ 35 | |||
Expiration Date of December 27, 2026 | ||||
Class of Warrant or Right | ||||
Number of Warrants | 175,000 | |||
Exercise Price | $ 35 | |||
Expiration Date of July 17, 2028 | ||||
Class of Warrant or Right | ||||
Number of Warrants | 7,200,002 | |||
Exercise Price | $ 2.25 |
Common Stock Warrants - Summary
Common Stock Warrants - Summary of warrants (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 USD ($) $ / shares shares | Sep. 30, 2023 USD ($) $ / shares shares | Jul. 17, 2023 USD ($) $ / shares shares | Jul. 13, 2023 $ / shares | |
Subsidiary, Sale of Stock | ||||
Warrants outstanding at the beginning | shares | 1,004,115 | |||
Warrants issued | shares | 7,200,002 | |||
Warrants outstanding at the end | shares | 8,204,117 | 8,204,117 | ||
Exercise price of warrants | $ / shares | $ 2.25 | |||
Warrants term | 5 years | |||
Gain from change in fair value of the warrant liability | $ | $ (11,739,000) | $ (11,739,000) | ||
Private Placement.. | ||||
Subsidiary, Sale of Stock | ||||
Warrants to purchase shares of common stock | shares | 7,200,002 | |||
Exercise price of warrants | $ / shares | $ 2.25 | |||
Warrants term | 5 years | |||
Fair value of warrants | $ | 9,800,000 | 9,800,000 | $ 21,500,000 | |
Transaction costs incurred | $ | $ 2,900,000 | |||
Gain from change in fair value of the warrant liability | $ | $ 11,700,000 | |||
Private Placement.. | Dividend yield | ||||
Subsidiary, Sale of Stock | ||||
Warrants, measurement input | 0 | 0 | 0 | |
Private Placement.. | Expected term | ||||
Subsidiary, Sale of Stock | ||||
Warrants, measurement input | 0.0479 | 0.0479 | 0.050 | |
Private Placement.. | Equity volatility | ||||
Subsidiary, Sale of Stock | ||||
Warrants, measurement input | 1.150 | 1.150 | 1.100 | |
Private Placement.. | Closing stock price | ||||
Subsidiary, Sale of Stock | ||||
Warrants, measurement input | $ / shares | 1.73 | 1.73 | 3.54 | |
Private Placement.. | Risk-free interest rate | ||||
Subsidiary, Sale of Stock | ||||
Warrants, measurement input | 0.0462 | 0.0462 | 0.0393 |
Basic and Diluted Net Loss pe_3
Basic and Diluted Net Loss per Common Share - Reconciliation of the weighted average number of common shares outstanding used in calculating basic and diluted net loss per share (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Numerator | ||||
Net loss per common share | $ (4,888,740) | $ (13,830,196) | $ (8,820,570) | $ (15,816,213) |
Denominator | ||||
Weighted-average common shares for basic net loss per share | 2,119,620 | 2,068,472 | 2,108,747 | 2,068,472 |
Weighted-average common shares for diluted net loss per share | 2,119,620 | 2,068,472 | 2,108,747 | 2,068,472 |
Basic net loss per common share | $ (2.31) | $ (6.69) | $ (4.18) | $ (7.65) |
Diluted net loss per common share | $ (2.31) | $ (6.69) | $ (4.18) | $ (7.65) |
Basic and Diluted Net Loss pe_4
Basic and Diluted Net Loss per Common Share - Potentially dilutive securities convertible into common shares that were excluded from the calculation of diluted net loss per share (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Statements | ||||
Total | 15,176,274 | 1,105,746 | 15,176,274 | 1,105,746 |
Stock Options | ||||
Statements | ||||
Total | 210,067 | 59,067 | 210,067 | 59,067 |
RSUs | ||||
Statements | ||||
Total | 42,564 | 42,564 | ||
Series A Convertible Preferred stock | ||||
Statements | ||||
Total | 6,762,090 | 6,762,090 | ||
Warrants | ||||
Statements | ||||
Total | 8,204,117 | 1,004,115 | 8,204,117 | 1,004,115 |
Marketing, Licensing and Dist_2
Marketing, Licensing and Distribution Agreements - Vivus (Details) | 9 Months Ended | 12 Months Ended | |||
Jan. 18, 2022 USD ($) | Sep. 30, 2016 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Marketing, Licensing and Distribution Agreements | |||||
Noncash decrease in accrued expenses related to Vivus settlement | $ (6,520,283) | ||||
Noncash decrease in accrued inventory purchases related to Vivus Settlement | (14,203,905) | ||||
Noncash decrease in API purchase commitment | $ 694,314 | 6,232,489 | |||
Gain on settlement with Vivus | 3,389,941 | ||||
API purchase commitment asset | 694,314 | $ 663,984 | |||
Accrued inventory purchases | 46,288 | ||||
License Agreement | Royalty on the first $500 million of net sales | |||||
Marketing, Licensing and Distribution Agreements | |||||
Threshold net sales | 500,000,000 | ||||
License Agreement | Milestone payment to be paid once $250 million in sales has been reached | |||||
Marketing, Licensing and Distribution Agreements | |||||
Threshold net sales | 250,000,000 | ||||
Milestone payment | 6,000,000 | ||||
License Agreement | Milestone payment to be paid after $250 million in sales has been reached | |||||
Marketing, Licensing and Distribution Agreements | |||||
Threshold net sales | 250,000,000 | ||||
Milestone payment | $ 3,200,000 | ||||
License Agreement | Vivus, Inc | |||||
Marketing, Licensing and Distribution Agreements | |||||
One-time fee to purchase and receive the license for the commercialization and exploitation of Stendra | $ 70,000,000 | ||||
License Agreement | Vivus, Inc | Royalty during the first, second, and third years following the expiration of the Royalty Period | |||||
Marketing, Licensing and Distribution Agreements | |||||
Royalty percentage | 2% | ||||
License Agreement | Vivus, Inc | Royalty following the fourth and fifth years following the end of the Royalty Period | |||||
Marketing, Licensing and Distribution Agreements | |||||
Royalty percentage | 1% | ||||
License Agreement | MTPC | |||||
Marketing, Licensing and Distribution Agreements | |||||
Royalty incurred | $ 170,822 | $ 135,816 | |||
Royalty receivable | 106,115 | ||||
License Agreement | MTPC | Royalty on the first $500 million of net sales | |||||
Marketing, Licensing and Distribution Agreements | |||||
Royalty percentage | 5% | ||||
License Agreement | MTPC | Royalty on net sales after $500 million | |||||
Marketing, Licensing and Distribution Agreements | |||||
Royalty percentage | 6% | ||||
Settlement Agreement | Vivus, Inc | |||||
Marketing, Licensing and Distribution Agreements | |||||
Inventory amount retained - API | $ 7,300,000 | ||||
Prepayment amount | 900,000 | ||||
Payment made for purchase order | $ 1,542,904 | ||||
Percentage of stendra tablets released | 100 | ||||
Noncash decrease in accrued expenses related to Vivus settlement | $ 6,500,000 | ||||
Noncash decrease in accrued inventory purchases related to Vivus Settlement | 14,200,000 | ||||
Noncash decrease in API purchase commitment | 6,200,000 | ||||
Gain on settlement with Vivus | 3,400,000 | ||||
Raw materials inventory | $ 1,000,000 | ||||
Settlement Agreement | Vivus, Inc | Other Current Assets | |||||
Marketing, Licensing and Distribution Agreements | |||||
API purchase commitment asset | 700,000 | 700,000 | |||
Settlement Agreement | Vivus, Inc | Other Noncurrent Assets | |||||
Marketing, Licensing and Distribution Agreements | |||||
Accrued inventory purchases, other assets | $ 4,400,000 | $ 5,100,000 | |||
Settlement Agreement | Vivus, Inc | Promissory Note | |||||
Marketing, Licensing and Distribution Agreements | |||||
Prepayment amount | 900,000 | ||||
Principal amount of notes payable | $ 10,201,758 |
Segment Information (Details)
Segment Information (Details) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) segment | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Results of operations by reportable segment | |||||
Net sales | $ 1,674,657 | $ (1,457,732) | $ 6,186,638 | $ 5,193,953 | |
Cost of goods sold | 408,475 | 286,525 | 1,473,073 | 1,408,086 | |
Selling, general and administrative expenses | 2,001,935 | 2,170,975 | 6,382,166 | 9,285,317 | |
Warrant issuance costs | 2,855,000 | 2,855,000 | |||
Gain on settlement of contingent liability | (3,389,941) | ||||
Research and development expenses | 389,093 | 735,916 | 1,574,760 | 1,562,518 | |
Depreciation and amortization expense | 826,795 | 1,560,870 | 2,480,385 | 4,682,610 | |
Intangible asset impairment | 7,460,000 | 7,460,000 | $ 7,460,000 | ||
Change in fair value of derivative liability | 430,000 | 430,000 | (460,000) | ||
Change in fair value of warrant liability | (11,739,000) | (11,739,000) | |||
Interest income | (168,481) | (287,722) | |||
Interest expense | 131,351 | 147,677 | 410,317 | 451,075 | |
Loss on issuance of Series A Preferred Stock | 11,088,997 | 11,088,997 | |||
Income tax expense | 10,501 | 10,501 | |||
Net loss | (4,549,508) | (13,830,196) | $ (8,481,338) | (15,816,213) | |
Operating segments | |||||
Statements | |||||
Number of operating segments | segment | 2 | ||||
Corporate | |||||
Results of operations by reportable segment | |||||
Selling, general and administrative expenses | 1,256,814 | 1,210,147 | $ 3,976,610 | 3,999,783 | |
Warrant issuance costs | 2,855,000 | 2,855,000 | |||
Change in fair value of derivative liability | 430,000 | 430,000 | (460,000) | ||
Change in fair value of warrant liability | (11,739,000) | (11,739,000) | |||
Interest income | (168,481) | (287,722) | |||
Interest expense | 131,351 | 410,317 | |||
Loss on issuance of Series A Preferred Stock | 11,088,997 | 11,088,997 | |||
Net loss | (3,854,681) | (1,210,147) | (6,734,202) | (3,539,783) | |
Prescription Medications | Operating segments | |||||
Results of operations by reportable segment | |||||
Net sales | 925,759 | (2,140,629) | 3,416,444 | 2,716,311 | |
Cost of goods sold | 85,388 | 36,067 | 343,109 | 525,073 | |
Selling, general and administrative expenses | 251,674 | 493,128 | 1,006,666 | 3,933,295 | |
Gain on settlement of contingent liability | (3,389,941) | ||||
Research and development expenses | 369,505 | 678,552 | 1,499,842 | 1,428,848 | |
Depreciation and amortization expense | 575,470 | 1,269,664 | 1,726,409 | 3,808,991 | |
Intangible asset impairment | 7,460,000 | 7,460,000 | |||
Interest expense | 147,677 | 451,075 | |||
Net loss | (356,278) | (12,225,717) | (1,159,582) | (11,501,030) | |
Medical Devices | Operating segments | |||||
Results of operations by reportable segment | |||||
Net sales | 748,898 | 682,897 | 2,770,194 | 2,477,642 | |
Cost of goods sold | 323,087 | 250,458 | 1,129,964 | 883,013 | |
Selling, general and administrative expenses | 493,447 | 467,700 | 1,398,890 | 1,352,239 | |
Research and development expenses | 19,588 | 57,364 | 74,918 | 133,670 | |
Depreciation and amortization expense | 251,325 | 291,206 | 753,976 | 873,619 | |
Income tax expense | 10,501 | 10,501 | |||
Net loss | $ (338,549) | $ (394,332) | $ (587,554) | $ (775,400) |
Segment Information - Net Sales
Segment Information - Net Sales by Geographic region (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Statements | ||||
Net sales | $ 1,674,657 | $ (1,457,732) | $ 6,186,638 | $ 5,193,953 |
United States | ||||
Statements | ||||
Net sales | 1,496,988 | (1,647,367) | 5,253,587 | 4,260,171 |
International | ||||
Statements | ||||
Net sales | $ 177,669 | $ 189,635 | $ 933,051 | $ 933,782 |
Segment Information - Segment a
Segment Information - Segment assets (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Statements | ||
Intangible assets, net | $ 9,771,764 | $ 12,244,484 |
Total segment assets | 38,914,168 | 32,421,214 |
Prescription Medications | ||
Statements | ||
Intangible assets, net | 5,459,960 | 7,178,704 |
Total segment assets | 32,810,715 | 25,831,048 |
Medical Devices | ||
Statements | ||
Intangible assets, net | 4,311,804 | 5,065,780 |
Total segment assets | $ 6,103,453 | $ 6,590,166 |
Private Placement (Details)
Private Placement (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||
Nov. 14, 2023 USD ($) shares | Jul. 17, 2023 USD ($) $ / shares shares | Jul. 13, 2023 USD ($) Y $ / shares installment shares | Jul. 31, 2023 USD ($) | Sep. 30, 2023 USD ($) Y $ / shares | Sep. 30, 2023 USD ($) Y $ / shares | Sep. 29, 2023 USD ($) | Dec. 31, 2022 $ / shares | |
Private Placement [Line Items] | ||||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||||
Exercise price of warrants | $ / shares | $ 2.25 | |||||||
Proceeds from gross proceeds | $ 15,000,000 | $ 15,000,003 | ||||||
Warrants term | 5 years | |||||||
Maximum percentage of outstanding shares approved for issuance in accordance with Nasdaq stock market rules | 19.99% | |||||||
Percentage of interest on issued and our outstanding Common Stock | 29% | |||||||
Embedded derivative instrument | ||||||||
Private Placement [Line Items] | ||||||||
Fair value of the bifurcated embedded derivative | $ 6,600,000 | $ 6,600,000 | ||||||
Loss from change in fair value of the derivative liability | $ 400,000 | |||||||
Fair value of our common stock | ||||||||
Private Placement [Line Items] | ||||||||
Embedded Derivative Liability, Measurement Input | $ / shares | 3.54 | 1.73 | 1.73 | |||||
Equity volatility | ||||||||
Private Placement [Line Items] | ||||||||
Embedded Derivative Liability, Measurement Input | 1.650 | 1.800 | 1.800 | |||||
Traded volume volatility | ||||||||
Private Placement [Line Items] | ||||||||
Embedded Derivative Liability, Measurement Input | 7.900 | 8.900 | 8.900 | |||||
Expected term | ||||||||
Private Placement [Line Items] | ||||||||
Embedded Derivative Liability, Measurement Input | Y | 1.38 | 1.17 | 1.17 | |||||
Risk-free interest rate | ||||||||
Private Placement [Line Items] | ||||||||
Embedded Derivative Liability, Measurement Input | 0.081 | 0.078 | 0.078 | |||||
Dividend yield | ||||||||
Private Placement [Line Items] | ||||||||
Embedded Derivative Liability, Measurement Input | 0.080 | 0.080 | 0.080 | |||||
Penalty dividend rate | ||||||||
Private Placement [Line Items] | ||||||||
Embedded Derivative Liability, Measurement Input | 0.150 | 0.150 | 0.150 | |||||
Probability of default | ||||||||
Private Placement [Line Items] | ||||||||
Embedded Derivative Liability, Measurement Input | 0.097 | 0.104 | 0.104 | |||||
Private Placement.. | ||||||||
Private Placement [Line Items] | ||||||||
Warrants to purchase shares of common stock | shares | 7,200,002 | |||||||
Exercise price of warrants | $ / shares | $ 2.25 | |||||||
Warrants term | 5 years | |||||||
Private Placement.. | Placement Agent | ||||||||
Private Placement [Line Items] | ||||||||
Warrants to purchase shares of common stock | shares | 533,334 | |||||||
Cash fee (Percentage) | 8% | |||||||
Series A Preferred Stock | ||||||||
Private Placement [Line Items] | ||||||||
Exercise price of warrants | $ / shares | $ 2.25 | |||||||
Number of equal monthly installments for redemption of preferred stock | installment | 13 | |||||||
Minimum trading days after the date that initial registration statement for considering first trading day of the calendar month | 25 days | |||||||
Percentage of redemptions payable in cash on installment redemption amount | 107% | |||||||
Percentage of the average of three lowest closing prices of common stock during the thirty trading day period immediately prior to amortization payment is due | 80% | |||||||
Number of trading days immediately prior to amortization payment is due considered for calculating conversion price | 30 days | |||||||
Conversion price for valuation of common stock | $ / shares | $ 0.396 | |||||||
Percentage of minimum price | 20% | |||||||
Common stock closing price per share limit for conversion of stock for 20 consecutive trading days | $ / shares | $ 6.75 | |||||||
Number of trading day considered for calculation of closing price limit of common stock for conversion | 20 days | |||||||
Daily dollar trading volume of common stock limit for conversion of stock | $ 2,000,000 | |||||||
Dividend rate | 8% | |||||||
Preferred stock, dividend accrued rate per annum | 15% | |||||||
Loss upon issuance | $ 11,100,000 | |||||||
Cash payable to investors | $ 1,368,547 | |||||||
Stated value of the Series A Preferred Shares | 1,153,846 | |||||||
Accrued dividends payable | 339,232 | $ 339,232 | 125,170 | |||||
Cash premium | 89,531 | 89,531 | $ 89,531 | |||||
Number of stock redeemed | shares | 1,154 | |||||||
Amount of stock redeemed for cash | $ 1,213,132 | |||||||
Number of common stock issued upon conversion | shares | 87,499 | |||||||
Value of common stock issued for conversion | $ 145,248 | |||||||
Preferred dividends at the stated dividend rate | 249,701 | 249,701 | ||||||
Series A Preferred Stock | Embedded derivative instrument | ||||||||
Private Placement [Line Items] | ||||||||
Fair value of the bifurcated embedded derivative | $ 6,100,000 | 6,100,000 | $ 6,100,000 | |||||
Total discount upon issuance | 15,000,000 | |||||||
Difference between the gross proceeds and the allocated residual fair value of embedded derivative | $ 8,900,000 | |||||||
Purchase Agreement | Private Placement.. | ||||||||
Private Placement [Line Items] | ||||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | |||||||
Proceeds from gross proceeds | $ 15,000,000 | |||||||
Purchase Agreement | Series A Preferred Stock | ||||||||
Private Placement [Line Items] | ||||||||
Initial conversion price | $ / shares | $ 2.25 | $ 2.25 | $ 2.25 | |||||
Purchase Agreement | Series A Preferred Stock | Private Placement.. | ||||||||
Private Placement [Line Items] | ||||||||
Aggregate shares agreed to sell | shares | 15,000 | |||||||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | |||||||
Preferred stock, stated value | $ / shares | $ 1,000 | |||||||
Maximum shares issuable upon conversion | shares | 6,666,668 | |||||||
Warrants to purchase shares of common stock | shares | 6,666,668 | |||||||
Exercise price of warrants | $ / shares | $ 2.25 | |||||||
Registration rights agreement | ||||||||
Private Placement [Line Items] | ||||||||
Percentage of conversion shares and warrant shares required to file for resale | 200% | |||||||
Threshold number of calendar days for filing resale | 30 days |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Level 3 | Sep. 30, 2023 USD ($) |
Warrant liability | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Total liabilities | $ 9,805,000 |
Bifurcated embedded derivative liability | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Total liabilities | $ 6,570,000 |
Fair Value Measurements - Chang
Fair Value Measurements - Change in the fair value of financial liabilities (Details) | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Change in the fair value of financial liabilities | |
Issuance | $ 21,544,000 |
Change in fair value of liability | (11,739,000) |
Balance on September 30, 2023 | 9,805,000 |
Bifurcated embedded derivative liability | |
Change in the fair value of financial liabilities | |
Issuance | 6,140,000 |
Change in fair value of liability | 430,000 |
Balance on September 30, 2023 | $ 6,570,000 |