Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2024 | Aug. 13, 2024 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2024 | |
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 | 9,606,678 | |
Entity Central Index Key | 0001815903 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) | Jun. 30, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash | $ 7,460,014 | $ 13,336,975 |
Accounts receivable, net | 1,776,531 | 2,226,151 |
Inventories | 1,433,217 | 1,610,391 |
Prepaid inventory | 1,414,320 | 1,182,899 |
Prepaid expenses and other current assets | 1,894,963 | 2,033,980 |
Total current assets | 13,979,045 | 20,390,396 |
Fixed assets, net | 23,846 | 28,957 |
Intangible assets, net | 7,541,171 | 8,971,737 |
API purchase commitment | 3,471,471 | 4,178,446 |
Right of use assets | 153,741 | 226,259 |
Total assets | 25,169,274 | 33,795,795 |
Current liabilities: | ||
Current portion of promissory note | 1,936,995 | 1,156,550 |
Accounts payable | 791,091 | 1,713,253 |
Accrued expenses | 6,673,591 | 5,360,077 |
Accrued Series A Convertible Preferred payments payable | 224,124 | 2,047,583 |
Other current liabilities | 350,544 | 493,288 |
Total current liabilities | 9,976,345 | 10,770,751 |
Promissory note, net of current portion | 5,697,128 | 6,857,364 |
Derivative Liability | 202,000 | 3,550,000 |
Other long-term liabilities | 107,756 | 137,657 |
Total liabilities | 15,983,229 | 21,315,772 |
Commitments and contingencies (see note 14) | ||
Series A convertible redeemable preferred stock (par value $0.0001 per share and $1,000 stated value), 15,000 and 15,000 shares authorized at June 30, 2024, and December 31, 2023, respectively; 4,039 and 10,022 shares issued and outstanding at June 30, 2024, and December 31, 2023, respectively; Liquidation preference of $4,585,929 and $11,271,365, as of June 30, 2024, and December 31, 2023, respectively. | 1,115,762 | 408,982 |
Stockholders' Equity: | ||
Common stock (par value $0.0001 per share, 250,000,000 and 250,000,000 shares authorized at June 30, 2024, and December 31, 2023, respectively; 9,297,538 and 2,991,377 shares issued and outstanding as of June 30, 2024, and December 31, 2023, respectively) | 930 | 298 |
Additional paid-in capital | 109,783,623 | 110,960,324 |
Accumulated deficit | (101,714,270) | (98,889,581) |
Total Stockholders' Equity | 8,070,283 | 12,071,041 |
Total Liabilities, Convertible Redeemable Preferred Stock and Stockholders' Equity | $ 25,169,274 | $ 33,795,795 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) | Jun. 30, 2024 | Dec. 31, 2023 |
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 | 15,000 |
Redeemable convertible preferred stock, issued (in shares) | 4,039 | 10,022 |
Redeemable convertible preferred stock, outstanding (in shares) | 4,039 | 10,022 |
Redeemable convertible preferred stock, Liquidation preference | $ 4,585,929 | $ 11,271,365 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 250,000,000 | 250,000,000 |
Common stock, shares issued | 9,297,538 | 2,991,377 |
Common stock, shares outstanding | 9,297,538 | 2,991,377 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||
Net sales | $ 1,421,471 | $ 1,994,011 | $ 2,810,276 | $ 4,511,983 |
Cost of goods sold | 329,110 | 513,857 | 660,939 | 1,064,599 |
Gross profit | 1,092,361 | 1,480,154 | 2,149,337 | 3,447,384 |
Operating expenses: | ||||
Selling, general and administrative | 2,286,630 | 2,249,592 | 4,998,088 | 4,380,231 |
Research and development expense | 368,798 | 866,575 | 1,924,750 | 1,185,668 |
Depreciation and amortization expense | 717,838 | 826,795 | 1,435,677 | 1,653,590 |
Total operating expenses | 3,373,266 | 3,942,962 | 8,358,515 | 7,219,489 |
Loss from operations | (2,280,905) | (2,462,808) | (6,209,178) | (3,772,105) |
Other income (expenses): | ||||
Change in fair value of derivative liability | 1,614,000 | 3,348,000 | ||
Interest income | 119,391 | 52,924 | 271,210 | 119,241 |
Interest expense, promissory note | (114,512) | (136,799) | (234,721) | (278,966) |
Total other income (expenses) | 1,618,879 | (83,875) | 3,384,489 | (159,725) |
Net loss before income taxes | (662,026) | (2,546,683) | (2,824,689) | (3,931,830) |
Net loss | (662,026) | $ (2,546,683) | (2,824,689) | $ (3,931,830) |
Preferred Stock dividend and cash premiums | (216,798) | (812,303) | ||
Preferred Stock accretion | (1,856,095) | (7,124,871) | ||
Net loss attributable to common stockholders | $ (2,734,919) | $ (10,761,863) | ||
Net loss per common share | ||||
Basic (in dollars per share) | $ (0.37) | $ (1.20) | $ (1.77) | $ (1.87) |
Diluted (in dollars per share) | $ (0.37) | $ (1.20) | $ (1.77) | $ (1.87) |
Weighted average common shares outstanding | ||||
Basic (in shares) | 7,388,107 | 2,117,581 | 6,072,349 | 2,103,220 |
Diluted (in shares) | 7,388,107 | 2,117,581 | 6,072,349 | 2,103,220 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN CONVERTIBLE REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY - USD ($) | Preferred Stock Convertible Redeemable Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
Balance at Dec. 31, 2022 | $ 208 | $ 107,428,652 | $ (90,726,393) | $ 16,702,467 | |
Balance (in shares) at Dec. 31, 2022 | 2,079,387 | ||||
Stock-based compensation expense | 173,652 | 173,652 | |||
Shares issued for vested RSU's | $ 3 | (3) | |||
Shares issued for vested RSU's (in shares) | 40,233 | ||||
Net loss | (3,931,830) | (3,931,830) | |||
Balance at Jun. 30, 2023 | $ 211 | 107,602,301 | (94,658,223) | 12,944,289 | |
Balance (in shares) at Jun. 30, 2023 | 2,119,620 | ||||
Balance at Mar. 31, 2023 | $ 209 | 107,558,987 | (92,111,540) | 15,447,656 | |
Balance (in shares) at Mar. 31, 2023 | 2,088,698 | ||||
Stock-based compensation expense | 43,316 | 43,316 | |||
Shares issued for vested RSU's | $ 2 | (2) | |||
Shares issued for vested RSU's (in shares) | 30,922 | ||||
Net loss | (2,546,683) | (2,546,683) | |||
Balance at Jun. 30, 2023 | $ 211 | 107,602,301 | (94,658,223) | 12,944,289 | |
Balance (in shares) at Jun. 30, 2023 | 2,119,620 | ||||
Balance at Dec. 31, 2023 | $ 408,982 | $ 298 | 110,960,324 | (98,889,581) | 12,071,041 |
Balance (in shares) at Dec. 31, 2023 | 10,022 | 2,991,377 | |||
Stock-based compensation expense | 197,215 | 197,215 | |||
Common Stock issued for services | $ 33 | 209,967 | 210,000 | ||
Common Stock issued for services (in shares) | 322,986 | ||||
Series A Preferred Stock accretion | $ 7,124,871 | (7,124,871) | (7,124,871) | ||
Series A Preferred Stock dividends | 754,962 | (754,962) | (754,962) | ||
Preferred Stock redemption including cash premium | $ (7,173,053) | $ 599 | 6,353,291 | 6,353,890 | |
Preferred Stock redemption including cash premium (in shares) | (5,983) | 5,983,175 | |||
Deemed dividends on Preferred Stock | 57,341 | 57,341 | |||
Net loss | (2,824,689) | (2,824,689) | |||
Balance at Jun. 30, 2024 | $ 1,115,762 | $ 930 | 109,783,623 | (101,714,270) | 8,070,283 |
Balance (in shares) at Jun. 30, 2024 | 4,039 | 9,297,538 | |||
Balance at Mar. 31, 2024 | $ 906,979 | $ 688 | 110,838,135 | (101,052,244) | 9,786,579 |
Balance (in shares) at Mar. 31, 2024 | 5,663 | 6,881,864 | |||
Stock-based compensation expense | 16,834 | 16,834 | |||
Common Stock issued for services | $ 25 | 99,975 | 100,000 | ||
Common Stock issued for services (in shares) | 245,158 | ||||
Series A Preferred Stock accretion | $ 1,856,095 | (1,856,095) | (1,856,095) | ||
Series A Preferred Stock dividends | (153,842) | (153,842) | (153,842) | ||
Preferred Stock redemption including cash premium | $ (1,801,154) | $ 217 | 901,572 | 901,789 | |
Preferred Stock redemption including cash premium (in shares) | (1,624) | 2,170,516 | |||
Deemed dividends on Preferred Stock | 62,956 | 62,956 | |||
Net loss | (662,026) | (662,026) | |||
Balance at Jun. 30, 2024 | $ 1,115,762 | $ 930 | $ 109,783,623 | $ (101,714,270) | $ 8,070,283 |
Balance (in shares) at Jun. 30, 2024 | 4,039 | 9,297,538 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Cash flows from operating activities: | ||
Net loss | $ (2,824,689) | $ (3,931,830) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 1,435,677 | 1,653,590 |
Bad debt expense (recoveries) | (25,352) | 4,499 |
Inventory and sample inventory reserve | 7,999 | 41,195 |
Amortization of right of use asset | 72,517 | 64,081 |
Derivative liability | (3,348,000) | |
Employee stock-based compensation | 197,215 | 173,652 |
Stock issued for services | 210,000 | |
Changes in operating assets and liabilities: | ||
Accounts receivable | 474,972 | (470,984) |
Inventories | 169,175 | 33,266 |
Prepaid inventory | (231,421) | |
Prepaid expenses and other current assets | 845,992 | 326,992 |
Accounts payable | (922,164) | (22,668) |
Accrued expenses | 1,313,514 | 1,143,909 |
Deferred revenue | (117,238) | (281,372) |
Other current liabilities | (25,506) | 24,586 |
Other long-term liabilities | (29,901) | (79,349) |
Net cash used in operating activities | (2,797,210) | (1,320,433) |
Cash flows from financing activities: | ||
Payment of promissory note | (379,791) | (721,034) |
Redemption of Series A Preferred Stock | (2,699,960) | |
Net cash used in financing activities | (3,079,751) | (721,034) |
Net decrease in cash | (5,876,961) | (2,041,467) |
Cash, beginning of period | 13,336,975 | 9,426,264 |
Cash, end of period | 7,460,014 | 7,384,797 |
Supplemental cash flow information: | ||
Cash paid for interest during the period | 120,209 | 278,966 |
Noncash Items: | ||
Noncash increase in inventory due to API reclass | 439,353 | |
Noncash decrease in API purchase commitment | 459,422 | |
Noncash decrease in other current assets: API purchase commitment | 20,069 | |
Noncash issuance of common stock to non-employee | $ 3 | |
Noncash redemption of Series A Preferred Stock | 6,353,890 | |
Accrued Series A Convertible Preferred payments payable | 224,124 | |
Accretion of Series A convertible preferred stock to redemption value | 7,124,871 | |
Accrual of Series convertible preferred stock dividends | $ 754,962 |
Nature of Operations, Basis of
Nature of Operations, Basis of Presentation, Liquidity and Going Concern | 6 Months Ended |
Jun. 30, 2024 | |
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 Petros Pharmaceuticals, Inc. (“Petros” or the “Company”) was incorporated in Delaware on May 14, 2020, for the purpose of effecting the transactions contemplated by that certain Agreement and Plan of Merger, dated as of May 17, 2020 (as amended, the “Merger Agreement”), by and between Petros, Neurotrope, Inc., a Nevada corporation (“Neurotrope”), Metuchen Pharmaceuticals LLC, a Delaware limited liability company (“Metuchen”), and certain subsidiaries of Petros and Neurotrope. Petros consists of wholly owned subsidiaries, Metuchen, Neurotrope, Timm Medical Technologies, Inc. (“Timm Medical”), and Pos-T-Vac, LLC (“PTV”). 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 have 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. Petros is committed to the goal of becoming a leading innovator in the emerging self-care market driving expanded access to key prescription pharmaceuticals as Over-The-Counter (“OTC”) treatment options. Currently, Petros is pursuing increased access for its flagship prescription ED therapy, Stendra®, via potential OTC designation. If ultimately approved by the FDA for OTC access, Stendra® may be the first in its class to achieve this marketing status, also establishing company know how as a proven platform for other prospective prescription therapeutics. 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. 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® OTC. Basis of Presentation and Principles of Consolidation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim financial reporting and with the instructions to Form 10-Q and Article 10 of Regulation S-X. In the opinion of management, the unaudited condensed consolidated financial statements included herein contain all adjustments necessary to present fairly the Company’s financial position and the results of its operations and cash flows for the interim periods presented. Such adjustments are of a normal recurring nature. The results of operations for the six months ended June 30, 2024, may not be indicative of results for the full year. These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and the notes to those statements for the year ended December 31, 2023, included in the Company’s Annual Report on Form 10-K initially filed with the SEC on April 1, 2024, as amended on May 31, 2024. All transactions between the consolidated entities have been eliminated in consolidation. Liquidity, Going Concern and Other Uncertainties In accordance with Financial Accounting Standards Board (the “FASB”) Accounting Standards Update (“ASU”) ASU 2014-15, Presentation of Financial Statements - going Concern (Subtopic 205-40) (“ASC 205-40”), the Company has the responsibility to evaluate whether conditions and/or events raise substantial doubt about its ability to meet its future financial obligations as they become due within one year after the date that the financial statements are issued. To date, the Company’s principal sources of capital used to fund operations have been the revenues from product sales, private sales, registered offerings and private placements of equity securities. The Company has experienced net losses and negative cash flows from operations since inception. As of June 30, 2024, the Company had cash of $7.5 million, positive working capital of $4.0 million, and accumulated deficit of $101.7 million. The Company’s plans include, or may include, utilizing cash on hand, as well as exploring additional ways to raise capital in addition to increasing cash flows from operations. In January 2022, the Company executed a promissory note in favor of Vivus in connection with the Vivus Settlement Agreement (as defined herein) in the principal amount of $10,201,758. As of June 30, 2024, the principal balance of the note is $7.6 million. The terms of this promissory note are discussed in Note 8 and Note 13. 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 unaudited condensed consolidated financial statements are issued. The accompanying interim unaudited condensed consolidated financial statements do not include any adjustments that might result from these uncertainties. The unaudited condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result should the Company be unable to continue as a going concern. 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 (as defined herein), 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 Private Placement to fund its OTC progress throughout 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 the Company’s Non-Prescription / OTC strategies related to Stendra®, which the Company believes 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 the Company’s current assumptions that negatively impact the Company’s 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. NASDAQ Capital Market Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard On May 15, 2024, the Company received notice from the Listing Qualifications Staff of Nasdaq indicating that, based upon the closing bid price of the Company’s common stock for the 30 consecutive business day period between April 3, 2024, through May 14, 2024, the Company did not meet the minimum bid price of $1.00 per share required for continued listing on the Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2). The letter also indicated that the Company would be provided with a compliance period until November 11, 2024, in which to regain compliance pursuant to Nasdaq Listing Rule 5810(c)(3)(A). |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2024 | |
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, 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, may be in excess of insured limits of $250,000. 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 Information. 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 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 service fees (“DSA”). 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 June 30, 2024, and December 31, 2023, the reserves for sales deductions were $5.1 million and $4.7 million, respectively. The most significant sales deductions included in this reserve relate to returns, contract rebates, and DSA fees. The Company’s estimates are based on factors such as 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 the Company’s 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 after expiration date. The provision for returns is based upon the Company’s estimates for future Stendra® returns and historical experience. The provision of returns is part of the variable consideration recorded at the time revenue is recognized. As of June 30, 2024, and December 31, 2023, the reserves for product returns were $4.9 million and $4.2 million, respectively, and are included as a component of accrued expenses. During the six months ended June 30, 2024, and 2023, respectively, the Company recorded $0.8 million and $0.8 million of returns as a reduction of gross revenue. During the three months ended June 30, 2024, and 2023, respectively, the Company recorded $0.3 million and $0.4 million of returns as a reduction of gross revenue. 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 the Company’s DSAs, as described below. Indirect rebates are rebates paid to indirect customers that have purchased the Company’s products from a wholesaler under a contract with us. The Company has entered into DSAs with certain 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 the Company’s pharmaceutical products held at their warehouse locations. See Note 3 Accounts Receivable, net for further discussion of these reserves. 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 do not require a prescription and include Vacuum Erection Devices, PreBoost, VenoSeal, penile injections (Rx), and urinary tract infection tests. 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. The Company has not made significant changes to the judgments made in applying Topic 606. As of June 30, 2024, and December 31, 2023, 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 June 30, 2024, and December 31, 2023. 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 June 30, 2024, and December 31, 2023, deferred revenue was $0 and $0.1 million respectively. Fair Value of Financial Instruments Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy: Level 1 – Quoted prices in active markets for identical assets or liabilities. Level 2 – Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market. Level 3 – Unobservable inputs which are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. Financial instruments recognized at historical amounts in the consolidated balance sheets consist of cash, accounts receivable, other current assets, accounts payable, accrued expenses, and other current liabilities. The Company believes that the carrying values of cash, accounts receivable, other current assets, accounts payable, accrued expenses, note payable, and other current liabilities approximate their fair values due to the short-term nature of these instruments. In connection with the Private Placement, the Company incurred liabilities related to derivatives arising from embedded features that were not clearly and closely related to the host instruments. The Company estimated the fair value of derivative liability utilizing Monte Carlo Simulation approach. These fair value measurements are based on significant inputs not observable in the market and thus represent Level 3 measurements within the fair value hierarchy. See Notes 16 and 17. Intangible Assets The Company accounts for recognized intangible assets at cost. Intangible assets with finite useful lives are amortized over the useful life that 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. The Company’s prepared projections including the undiscounted cash flows of the remaining estimated useful lives through December 2031 for the medical device products. Management continued to analyze the Company’s intangible assets during 2024. Management noted that the Company’s financial results were consistent with previous projections. Based on its analysis, Management concluded that there were no triggering events noted that would indicate a potential impairment for long-lived assets for any of the two asset groups, Metuchen Pharmaceuticals and TIMM/PTV. Derivative Financial Instruments The Company evaluates all its financial instruments to determine if such instruments contain features that qualify as embedded derivatives per ASC 815, Derivatives and Hedging Preferred Stock The Company records shares of convertible preferred stock at their respective fair values on the dates of issuance, net of issuance costs. The Company concluded that the Series A Preferred Stock is more akin to a debt-type instrument than an equity-type instrument, therefore certain conversion features associated with the convertible preferred stock were deemed to not be clearly and closely related to the host instrument and were bifurcated as a derivative under ASC 815. The Company has applied the guidance in ASC 480-10-S99-3A, SEC Staff Announcement: Classification and Measurement of Redeemable Securities Recent Accounting Pronouncements Accounting Pronouncements Not Yet Adopted In November 2023, the Financial Accounting Standards Board (FASB) issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (ASU 2023-07), which requires an enhanced disclosure of significant segment expenses on an annual and interim basis. This guidance will be effective for the annual periods beginning the year ended December 31, 2024, and for interim periods beginning January 1, 2025. Early adoption is permitted. Upon adoption, the guidance should be applied retrospectively to all prior periods presented in the financial statements. The Company is currently evaluating segment disclosures related to its annual report for fiscal year 2024. In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (ASU 2023-09), which improves the transparency of income tax disclosures by requiring consistent categories and greater disaggregation of information in the effective tax rate reconciliation and income taxes paid disaggregated by jurisdiction. It also includes certain other amendments to improve the effectiveness of income tax disclosures. This guidance will be effective for the annual periods beginning the year ended December 31, 2025. Early adoption is permitted. Upon adoption, the guidance can be applied prospectively or retrospectively. The Company is currently evaluating income tax disclosures related to its annual report for fiscal year 2025. |
Accounts Receivable, net
Accounts Receivable, net | 6 Months Ended |
Jun. 30, 2024 | |
Accounts Receivable, net | |
Accounts Receivable, net | 3) Accounts Receivable, net Accounts receivable, net is comprised of the following: June 30, December 31, 2024 2023 Gross accounts receivables $ 2,099,868 $ 2,887,317 Distribution service fees (117,049) (398,968) Chargebacks accrual (5,983) (2,462) Cash discount allowances (22,979) (24,639) Allowance for credit losses (177,326) (235,097) Total accounts receivable, net $ 1,776,531 $ 2,226,151 For the six months ended June 30, 2024, gross billings to customers representing 10% or more of the Company’s total gross billings included three customers which represented approximately 27%, 25%, and 14% of total gross billings, respectively. For the six months ended June 30, 2023, gross billings to customers representing 10% or more of the Company’s total gross billings included four customers which represented approximately 23%, 18%, 17% and 10% of total gross billings, respectively. For the three months ended June 30, 2024, gross billings to customers representing 10% or more of the Company’s total gross billings included three customers which represented approximately 28%, 25%, and 12% of total gross billings, respectively. For the three months ended June 30, 2023, gross billings to customers representing 10% or more of the Company’s total gross billings included three customers which represented approximately 24%, 19%, and 16% of total gross billings, respectively. Receivables from customers representing 10% or more of the Company’s gross accounts receivable included three customers at June 30, 2024, equal to 28%, 25%, and 22%, respectively. Receivables from customers representing 10% or more of the Company’s gross accounts receivable included three customers at December 31, 2023, equal to 35%, 22% and 18%, respectively. |
Inventories
Inventories | 6 Months Ended |
Jun. 30, 2024 | |
Inventories | |
Inventories | 4) Inventories Inventory is comprised of the following: June 30, 2024 December 31, 2023 Raw Materials $ 1,321,107 $ 1,430,139 Finished goods 112,110 180,252 Total inventory $ 1,433,217 $ 1,610,391 Finished goods are net of valuation reserves of $303,410 and $295,411 as of June 30, 2024, and December 31, 2023, respectively. |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 6 Months Ended |
Jun. 30, 2024 | |
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: June 30, 2024 December 31, 2023 Prepaid insurance $ 128,319 $ 45,664 Prepaid FDA fees 312,551 937,652 API purchase commitment asset (see Note 13) 1,180,283 704,729 Other prepaid expenses 187,263 234,459 Other current assets 86,547 111,476 Total prepaid expenses and other current assets $ 1,894,963 $ 2,033,980 |
Intangible Assets
Intangible Assets | 6 Months Ended |
Jun. 30, 2024 | |
Intangible Assets | |
Intangible Assets | 6) Intangible Assets Balance at December 31, 2022 $ 12,244,484 Amortization expense (3,272,747) Balance at December 31, 2023 8,971,737 Amortization expense (1,430,566) Balance at June 30, 2024 $ 7,541,171 The future annual amortization related to the Company’s intangible assets is as follows as of June 30, 2024: 2024 (remaining 6 months) $ 1,370,058 2025 1,754,329 2026 1,442,186 2027 1,212,871 2028 996,636 Thereafter 765,091 Total $ 7,541,171 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 June 30, 2024, are $3.9 million, $2.8 million and $0.8 million, respectively. The carrying value of the Stendra® product, Timm Medical product, and PTV product as of December 31, 2023, were $4.9 million, $3.2 million and $0.9 million, respectively. During the six months ended June 30, 2024, and 2023, respectively, the Company recorded $1.4 million and $1.6 million of amortization expense. During the three months ended June 30, 2024, and 2023, respectively, the Company recorded $0.7 million and $0.8 million of amortization expense. |
Accrued Expenses
Accrued Expenses | 6 Months Ended |
Jun. 30, 2024 | |
Accrued Expenses | |
Accrued Expenses | 7) Accrued Expenses Accrued expenses are comprised of the following: June 30, 2024 December 31, 2023 Accrued product returns $ 4,944,502 $ 4,178,176 Accrued contract rebates 48,552 128,562 Due to 3PL/Wholesalers 62,284 75,727 Accrued bonuses 964,418 665,184 Accrued professional fees — 15,000 Accrued R&D fees 601,952 100,668 Other accrued expenses 51,883 196,760 Total accrued expenses $ 6,673,591 $ 5,360,077 |
Debt
Debt | 6 Months Ended |
Jun. 30, 2024 | |
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. For the six months ended June 30, 2024, and 2023, the Company paid Vivus $0.5 million and $1.0 million, respectively. As of June 30, 2024, and December 31, 2023, the principal balance on the Note is $7.6 million and $8.0 million, respectively. Future minimum principal payments of the promissory note are as follows: 2024 (remaining 6 months) $ 776,759 2025 2,720,940 2026 3,264,351 2027 872,073 Total $ 7,634,123 Less: current portion (1,936,995) Promissory note, net of current portion $ 5,697,128 |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2024 | |
Stockholders' Equity | |
Stockholders' Equity | 9) Stockholders’ Equity On December 21, 2023, the Company approved and accrued for the issuance of $200,000 of common stock, payable in two equal installments, with the first installment to be paid upon approval by the Board and the second installment six months after the first installment, to CorProminence, LLC (“CoreIR”) for services rendered pursuant to a Marketing and Consulting Agreement. The first installment of 70,922 shares was issued on February 29, 2024. The second installment of 245,158 shares was issued on June 21, 2024. On January 5, 2024, the Company executed an advisory agreement with Maxim Group LLC (“Maxim”) that included the issuance of $10,000 of the Company’s restricted common stock per month and issued every six months starting upon the execution of the agreement. The first installment of 6,906 shares was issued on January 5, 2024. The Company accrued for the issuance of $50,000 of restricted common stock during the six months ended June 30, 2024. |
Stock Options
Stock Options | 6 Months Ended |
Jun. 30, 2024 | |
Stock Options. | |
Stock Options | 10) Stock Options The following is a summary of stock options for the six months ended June 30, 2024: Weighted-Average Weighted- Remaining Aggregate Intrinsic Number of Average Contractual Value Shares Exercise Price Term (Years) ($ in thousands) Options outstanding at December 31, 2023 509,133 $ 4.75 9.46 $ 66 Options granted — — — — Less: options forfeited — — — — Less: options expired/cancelled — — — — Less: options exercised — — — — Options outstanding at June 30, 2024 509,133 $ 4.75 9.23 $ — Options exercisable at June 30, 2024 454,600 $ 5.15 8.90 $ — Stock-based compensation expense recognized for the six months ended June 30, 2024, and 2023 was $197,215 and $173,652, respectively, and is recorded in general and administrative expenses in the consolidated statements of operations. As of June 30, 2024, there is no unrecognized stock-based compensation expense (excluding performance awards). Stock - based compensation expense recognized for the three months ended June 30, 2024, and 2023 was $16,834 and $43,316, respectively |
Common Stock Warrants
Common Stock Warrants | 6 Months Ended |
Jun. 30, 2024 | |
Common Stock Warrants | |
Common Stock Warrants | 11) Common Stock Warrants The following is a summary of warrants for the six months ended June 30, 2024: Aggregate Intrinsic Weighted-Average Remaining Value ($ in Number of Warrants Exercise Price Contractual Term thousands) Warrants outstanding - December 31, 2023 8,203,839 $ 14.93 4.3 $ — Warrants issued — — — — Warrants exercised — — — — Warrants expired (11,768) 261.18 — — Warrants outstanding and exercisable- June 30, 2024 8,192,071 $ 14.57 3.8 $ — |
Dilutive convertible securities
Dilutive convertible securities | 6 Months Ended |
Jun. 30, 2024 | |
Dilutive convertible securities | |
Dilutive convertible securities | 12) Dilutive convertible securities The following table summarizes the potentially dilutive securities convertible into common shares that were excluded from the calculation of diluted net income (loss) per share because their inclusion would have been antidilutive: For the Three Months Ended For the Six Months Ended June 30, June 30, 2024 2023 2024 2023 Stock Options 509,133 210,067 509,133 210,067 Series A Convertible Preferred stock 2,038,191 — 2,038,191 — Warrants 8,192,071 1,004,115 8,192,071 1,004,115 Total 10,739,395 1,214,182 10,739,395 1,214,182 |
Marketing, Licensing and Distri
Marketing, Licensing and Distribution Agreements | 6 Months Ended |
Jun. 30, 2024 | |
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. 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. API inventory is not a finished good. 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 June 30, 2024, and December 31, 2023, there was $1.2 million and $0.7 million respectively included in other current assets (see Note 5 Prepaid Expenses and Other Current Assets). As of June 30, 2024, and December 31, 2023, there was $3.5 million and $4.2 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 six months ended June 30, 2024, and 2023. During the six months ended June 30, 2024, and 2023, the Company incurred royalties to MTPC for Stendra® of $61,406 and $124,534, respectively. During the three months ended June 30, 2024, and 2023, the Company incurred royalties to MTPC for Stendra® of $30,751 and $49,220, respectively. Royalties incurred were included in cost of goods sold in the consolidated statements of operations. As of June 30, 2024, the Company had a payable for royalties of $4,903, which is included in accrued expenses in the accompanying consolidated balance sheets. As of December 31, 2023, the Company had a receivable for royalties of $56,503, which is included in other current assets. (see Note 7 Accrued Expenses and Note 5 Prepaid Expenses 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. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2024 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 14) Commitments and Contingencies (a) Legal Proceedings On July 14, 2020, Greg Ford, the former 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. From time to time, the Company is involved in various legal matters arising in the normal course of business. The Company does not expect the outcome of such proceedings, either individually or in the aggregate, to have a material effect on the Company’s financial position, cash flows or results of operations. (b) Contract Research The Company is currently conducting non-clinical consumer studies in connection with the pursuit of potential FDA approval for Stendra® Non-Prescription OTC use in treating ED. The Company has contracted with a leading Contract Research Organization (“CRO”) in the conduct of Rx-to-OTC Switch development including self-selection studies, human factors studies and various web app studies. The Company has committed approximately $1.4 million through multiple task orders/statements of work with the CRO to perform these studies. As of June 30, 2024, these projects are approximately 82% complete. The Company expects the CRO to complete these studies during the third quarter of 2024. |
Segment Information
Segment Information | 6 Months Ended |
Jun. 30, 2024 | |
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 six months ended June 30, 2024, are summarized as follows: Prescription Medical For the Six Months Ended June 30, 2024 Medications Devices Corporate Consolidated Net sales $ 1,228,115 $ 1,582,161 $ — $ 2,810,276 Cost of goods sold 145,327 515,612 — 660,939 Selling, general and administrative expenses 1,302,928 1,072,556 2,622,604 4,998,088 Research and development expenses 1,924,750 — — 1,924,750 Depreciation and amortization expense 1,000,610 435,067 — 1,435,677 Change in fair value of derivative liability — — (3,348,000) (3,348,000) Interest income — — (271,210) (271,210) Interest expense — — 234,721 234,721 Net (loss) and income $ (3,145,500) $ (441,074) $ 761,885 $ (2,824,689) The Company’s results of operations by reportable segment for the six months ended June 30, 2023, are summarized as follows: Prescription Medical For the Six Months Ended June 30, 2023 Medications Devices Corporate Consolidated Net sales $ 2,490,686 $ 2,021,297 $ — $ 4,511,983 Cost of goods sold 257,721 806,878 — 1,064,599 Selling, general and administrative expenses 754,993 905,442 2,719,796 4,380,231 Research and development expenses 1,130,338 55,330 — 1,185,668 Depreciation and amortization expense 1,150,939 502,651 — 1,653,590 Interest income — — (119,241) (119,241) Interest expense — — 278,966 278,966 Net loss $ (803,305) $ (249,004) $ (2,879,521) $ (3,931,830) The Company’s results of operations by reportable segment for the three months ended June 30, 2024, are summarized as follows: Prescription Medical For the Three Months Ended June 30, 2024 Medications Devices Corporate Consolidated Net sales $ 615,022 $ 806,449 $ — $ 1,421,471 Cost of goods sold 69,971 259,139 — 329,110 Selling, general and administrative expenses 625,030 569,782 1,091,818 2,286,630 Research and development expenses 368,978 — — 368,798 Depreciation and amortization expense 500,305 217,533 — 717,838 Change in fair value of derivative liability — — (1,614,000) (1,614,000) Interest income — — (119,391) (119,391) Interest expense — — 114,512 114,512 Net loss $ (949,082) $ (240,005) $ 527,061 $ (662,026) The Company’s results of operations by reportable segment for the three months ended June 30, 2023, are summarized as follows: Prescription Medical For the Three Months Ended June 30, 2023 Medications Devices Corporate Consolidated Net sales $ 984,408 $ 1,009,603 $ — $ 1,994,011 Cost of goods sold 83,451 430,406 — 513,857 Selling, general and administrative expenses 258,145 481,572 1,509,875 2,249,592 Research and development expenses 865,122 1,453 — 866,575 Depreciation and amortization expense 575,470 251,325 — 826,795 Interest income — — (52,924) (52,924) Interest expense — — 136,799 136,799 Net loss $ (797,780) $ (155,153) $ (1,593,750) $ (2,546,683) The following table reflects net sales by geographic region for the three and six months ended June 30, 2024, and 2023: For the Three Months Ended For the Six Months Ended June 30, June 30, Net sales 2024 2023 2024 2023 United States $ 1,105,433 $ 1,597,829 $ 2,284,277 $ 3,756,599 International 316,038 396,182 525,999 755,384 $ 1,421,471 $ 1,994,011 $ 2,810,276 $ 4,511,983 No individual country other than the United States accounted for 10% of total sales for the three and six months ended June 30, 2024, and 2023. The Company’s assets by reportable segment and reconciliation of segment assets to consolidated assets as of June 30, 2024, are summarized as follows: Prescription Medical Medications Devices Consolidated Intangible assets, net $ 3,908,249 $ 3,632,922 $ 7,541,171 Total segment assets $ 19,705,255 $ 5,464,019 $ 25,169,274 The Company’s assets by reportable segment and reconciliation of segment assets to consolidated assets as of December 31, 2023, are summarized as follows: Prescription Medical Medications Devices Consolidated Intangible assets, net $ 4,903,749 $ 4,067,988 $ 8,971,737 Total segment assets $ 27,891,180 $ 5,904,615 $ 33,795,795 |
Private Placement
Private Placement | 6 Months Ended |
Jun. 30, 2024 | |
Private Placement. | |
Private Placement | 16) Private Placement On July 13, 2023, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain accredited investors (the “Investors”), pursuant to which the Company agreed to sell in a private placement to the Investors (i) an aggregate of 15,000 shares of the Company’s 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 the Company’s 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 June 30, 2024, the Conversion Price and the exercise price of the Warrants was equal to $2.25 per share. On March 21, 2024, the Company entered into Omnibus Waiver and Amendments with the investors named therein, effective December 31, 2023 (the “Waiver and Amendment”). The Waiver and Amendment provides that certain equity awards granted to directors, officers, employees of the Company under the Company’s 2020 Omnibus Incentive Compensation Plan are deemed to constitute “Excluded Securities” under the Transaction Documents (as such term is defined in the Purchase Agreement) and waives the applicability of certain other provisions of the Transaction Documents with respect to such grants. The Waiver and Amendment also amended certain terms of the Warrants relating to the rights of the holders of the Warrants to provide that, in the event of a Fundamental Transaction (as defined in the Warrants) that is not within the Company’s control, including not approved by the Company’s Board of Directors, the holder of a Warrant shall only be entitled to receive from the Company or any successor entity the same type or form of consideration (and in the same proportion), at the Black Scholes Value of the unexercised portion of such Warrant, that is being offered and paid to the holders of the Company’s common stock in connection with the Fundamental Transaction. 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). The Company is required to redeem the Series A Preferred Shares in 13 equal monthly installments, commencing on November thirty The holders of the Series A Preferred Shares are entitled to dividends of 8% per annum, compounded monthly, which are payable, at the Company’s 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, the Company 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. During December 2023, the Company issued as equity awards, shares of Common Stock and options to purchase shares of Common Stock representing an aggregate of 348,711 shares of Common Stock and shares of Common Stock issuable upon exercise of the options to certain directors, officers, and employees of the Company, representing an aggregate number of shares of Common Stock in excess of 5% of the shares of Common Stock issued and outstanding immediately prior to the date of the Purchase Agreement (the “December Issuances”). Under the terms of the Certificate of Designations, the Conversion Price of the Series A Preferred Shares was required to be adjusted as a result of the December Issuances. 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 unaudited condensed consolidated statements of operations. During the three and six months ended June 30, 2024, the Company recorded a gain of $1,614,000 and $3,348,000, respectively, related to the change in fair value of the derivative liability which is recorded in other income (expense) on the unaudited consolidated statements of operations. The Company estimated the $202,000 fair value of the bifurcated embedded derivative at June 30, 2024 using a Monte Carlo simulation model, with the following inputs the fair value of the Company’s common stock of $0.46 on the valuation date, estimated equity volatility of 105.0%, estimated traded volume volatility of 235.0%, the time to maturity of 0.42 years, risk free rate of 5.38%, a discounted market interest rate of 20.5%, dividend rate of 8.0%, a penalty dividend rate of 15.0%, and probability of default of 5.6%. As of June 30, 2024, the Company has notified the investors of its intention to redeem the upcoming installments due in cash and recorded a liability of $224,124 representing the cash payable to investors which includes $188,953 of the stated value of the Series A Preferred Shares, $20,505 of accrued dividends payable, and $14,666 for the cash premium which was recognized as a deemed dividend. During the three months ended June 30, 2024, the Company redeemed a total of 1,624 Series A Preferred Shares in cash for $1,578,550 and issued 2,170,516 shares of Common Stock pursuant to the terms of the Certificate of Designations, equal to $901,789. During the three months ended June 30, 2024, the Company recognized a total of $216,798 of preferred dividends consisting of $153,842 of preferred dividends at the stated dividend rate, and $62,956 of cash premiums recognized as deemed dividends. During the six months ended June 30, 2024, the Company redeemed a total of 5,983 Series A Preferred Shares for cash equal to $2,699,960 and issued 5,983,175 shares of Common Stock, elected pursuant to the terms of the Certificate of Designations, equal to $6,353,890. During the six months ended June 30, 2024, the Company recognized a total of $812,303 of preferred dividends consisting of $754,962 of preferred dividends at the stated dividend rate, and $57,341 of cash premium recognized as a deemed dividend. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2024 | |
Fair Value Measurements | |
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 quarter ended June 30, 2024. The carrying amounts of cash equivalents, accounts receivable, other current assets, other assets, accounts payable, and accrued expenses approximated their fair values as of June 30, 2024, 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 the Company’s common stock and estimates for the equity volatility and traded volume volatility of the Company’s 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 the Company’s probability of default. 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 June 30, 2024, and indicates the fair value hierarchy of the valuation inputs the Company utilized to determine such fair value: June 30, Description Level 2024 Liabilities: Bifurcated embedded derivative liability 3 $ 202,000 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, 2023 $ 3,550,000 Change in fair value of bifurcated embedded derivative (3,348,000) Balance on June 30, 2024 $ 202,000 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Pay vs Performance Disclosure | ||||
Net Income (Loss) | $ (662,026) | $ (2,546,683) | $ (2,824,689) | $ (3,931,830) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Jun. 30, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2024 | |
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, 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, may be in excess of insured limits of $250,000. |
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 Information. |
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 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 service fees (“DSA”). 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 June 30, 2024, and December 31, 2023, the reserves for sales deductions were $5.1 million and $4.7 million, respectively. The most significant sales deductions included in this reserve relate to returns, contract rebates, and DSA fees. The Company’s estimates are based on factors such as 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 the Company’s 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 after expiration date. The provision for returns is based upon the Company’s estimates for future Stendra® returns and historical experience. The provision of returns is part of the variable consideration recorded at the time revenue is recognized. As of June 30, 2024, and December 31, 2023, the reserves for product returns were $4.9 million and $4.2 million, respectively, and are included as a component of accrued expenses. During the six months ended June 30, 2024, and 2023, respectively, the Company recorded $0.8 million and $0.8 million of returns as a reduction of gross revenue. During the three months ended June 30, 2024, and 2023, respectively, the Company recorded $0.3 million and $0.4 million of returns as a reduction of gross revenue. 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 the Company’s DSAs, as described below. Indirect rebates are rebates paid to indirect customers that have purchased the Company’s products from a wholesaler under a contract with us. The Company has entered into DSAs with certain 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 the Company’s pharmaceutical products held at their warehouse locations. See Note 3 Accounts Receivable, net for further discussion of these reserves. 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 do not require a prescription and include Vacuum Erection Devices, PreBoost, VenoSeal, penile injections (Rx), and urinary tract infection tests. 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. The Company has not made significant changes to the judgments made in applying Topic 606. As of June 30, 2024, and December 31, 2023, 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 June 30, 2024, and December 31, 2023. 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 June 30, 2024, and December 31, 2023, deferred revenue was $0 and $0.1 million respectively. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy: Level 1 – Quoted prices in active markets for identical assets or liabilities. Level 2 – Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market. Level 3 – Unobservable inputs which are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. Financial instruments recognized at historical amounts in the consolidated balance sheets consist of cash, accounts receivable, other current assets, accounts payable, accrued expenses, and other current liabilities. The Company believes that the carrying values of cash, accounts receivable, other current assets, accounts payable, accrued expenses, note payable, and other current liabilities approximate their fair values due to the short-term nature of these instruments. In connection with the Private Placement, the Company incurred liabilities related to derivatives arising from embedded features that were not clearly and closely related to the host instruments. The Company estimated the fair value of derivative liability utilizing Monte Carlo Simulation approach. These fair value measurements are based on significant inputs not observable in the market and thus represent Level 3 measurements within the fair value hierarchy. See Notes 16 and 17. |
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 that 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. The Company’s prepared projections including the undiscounted cash flows of the remaining estimated useful lives through December 2031 for the medical device products. Management continued to analyze the Company’s intangible assets during 2024. Management noted that the Company’s financial results were consistent with previous projections. Based on its analysis, Management concluded that there were no triggering events noted that would indicate a potential impairment for long-lived assets for any of the two asset groups, Metuchen Pharmaceuticals and TIMM/PTV. |
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 per ASC 815, Derivatives and Hedging |
Preferred Stock | Preferred Stock The Company records shares of convertible preferred stock at their respective fair values on the dates of issuance, net of issuance costs. The Company concluded that the Series A Preferred Stock is more akin to a debt-type instrument than an equity-type instrument, therefore certain conversion features associated with the convertible preferred stock were deemed to not be clearly and closely related to the host instrument and were bifurcated as a derivative under ASC 815. The Company has applied the guidance in ASC 480-10-S99-3A, SEC Staff Announcement: Classification and Measurement of Redeemable Securities |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Accounting Pronouncements Not Yet Adopted In November 2023, the Financial Accounting Standards Board (FASB) issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (ASU 2023-07), which requires an enhanced disclosure of significant segment expenses on an annual and interim basis. This guidance will be effective for the annual periods beginning the year ended December 31, 2024, and for interim periods beginning January 1, 2025. Early adoption is permitted. Upon adoption, the guidance should be applied retrospectively to all prior periods presented in the financial statements. The Company is currently evaluating segment disclosures related to its annual report for fiscal year 2024. In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (ASU 2023-09), which improves the transparency of income tax disclosures by requiring consistent categories and greater disaggregation of information in the effective tax rate reconciliation and income taxes paid disaggregated by jurisdiction. It also includes certain other amendments to improve the effectiveness of income tax disclosures. This guidance will be effective for the annual periods beginning the year ended December 31, 2025. Early adoption is permitted. Upon adoption, the guidance can be applied prospectively or retrospectively. The Company is currently evaluating income tax disclosures related to its annual report for fiscal year 2025. |
Accounts Receivable, net (Table
Accounts Receivable, net (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Accounts Receivable, net | |
Schedule of accounts receivable | June 30, December 31, 2024 2023 Gross accounts receivables $ 2,099,868 $ 2,887,317 Distribution service fees (117,049) (398,968) Chargebacks accrual (5,983) (2,462) Cash discount allowances (22,979) (24,639) Allowance for credit losses (177,326) (235,097) Total accounts receivable, net $ 1,776,531 $ 2,226,151 |
Inventories (Tables)
Inventories (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Inventories | |
Schedule of inventories | June 30, 2024 December 31, 2023 Raw Materials $ 1,321,107 $ 1,430,139 Finished goods 112,110 180,252 Total inventory $ 1,433,217 $ 1,610,391 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Prepaid Expenses and Other Current Assets. | |
Schedule of prepaid expenses and other current assets | June 30, 2024 December 31, 2023 Prepaid insurance $ 128,319 $ 45,664 Prepaid FDA fees 312,551 937,652 API purchase commitment asset (see Note 13) 1,180,283 704,729 Other prepaid expenses 187,263 234,459 Other current assets 86,547 111,476 Total prepaid expenses and other current assets $ 1,894,963 $ 2,033,980 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Intangible Assets | |
Schedule of intangible assets | Balance at December 31, 2022 $ 12,244,484 Amortization expense (3,272,747) Balance at December 31, 2023 8,971,737 Amortization expense (1,430,566) Balance at June 30, 2024 $ 7,541,171 |
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 June 30, 2024: 2024 (remaining 6 months) $ 1,370,058 2025 1,754,329 2026 1,442,186 2027 1,212,871 2028 996,636 Thereafter 765,091 Total $ 7,541,171 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Accrued Expenses | |
Schedule of accrued expenses | June 30, 2024 December 31, 2023 Accrued product returns $ 4,944,502 $ 4,178,176 Accrued contract rebates 48,552 128,562 Due to 3PL/Wholesalers 62,284 75,727 Accrued bonuses 964,418 665,184 Accrued professional fees — 15,000 Accrued R&D fees 601,952 100,668 Other accrued expenses 51,883 196,760 Total accrued expenses $ 6,673,591 $ 5,360,077 |
Debt (Tables)
Debt (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Debt | |
Schedule of future principal payments of the promissory note | 2024 (remaining 6 months) $ 776,759 2025 2,720,940 2026 3,264,351 2027 872,073 Total $ 7,634,123 Less: current portion (1,936,995) Promissory note, net of current portion $ 5,697,128 |
Stock Options (Tables)
Stock Options (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Stock Options. | |
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, 2023 509,133 $ 4.75 9.46 $ 66 Options granted — — — — Less: options forfeited — — — — Less: options expired/cancelled — — — — Less: options exercised — — — — Options outstanding at June 30, 2024 509,133 $ 4.75 9.23 $ — Options exercisable at June 30, 2024 454,600 $ 5.15 8.90 $ — |
Common Stock Warrants (Tables)
Common Stock Warrants (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Common Stock Warrants | |
Summary of warrants | Aggregate Intrinsic Weighted-Average Remaining Value ($ in Number of Warrants Exercise Price Contractual Term thousands) Warrants outstanding - December 31, 2023 8,203,839 $ 14.93 4.3 $ — Warrants issued — — — — Warrants exercised — — — — Warrants expired (11,768) 261.18 — — Warrants outstanding and exercisable- June 30, 2024 8,192,071 $ 14.57 3.8 $ — |
Dilutive convertible securiti_2
Dilutive convertible securities (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Dilutive convertible securities | |
Summary of potentially dilutive securities convertible into common shares | For the Three Months Ended For the Six Months Ended June 30, June 30, 2024 2023 2024 2023 Stock Options 509,133 210,067 509,133 210,067 Series A Convertible Preferred stock 2,038,191 — 2,038,191 — Warrants 8,192,071 1,004,115 8,192,071 1,004,115 Total 10,739,395 1,214,182 10,739,395 1,214,182 |
Segment Information (Tables)
Segment Information (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Segment Information | |
Schedule of results of operations by reportable segment | Prescription Medical For the Six Months Ended June 30, 2024 Medications Devices Corporate Consolidated Net sales $ 1,228,115 $ 1,582,161 $ — $ 2,810,276 Cost of goods sold 145,327 515,612 — 660,939 Selling, general and administrative expenses 1,302,928 1,072,556 2,622,604 4,998,088 Research and development expenses 1,924,750 — — 1,924,750 Depreciation and amortization expense 1,000,610 435,067 — 1,435,677 Change in fair value of derivative liability — — (3,348,000) (3,348,000) Interest income — — (271,210) (271,210) Interest expense — — 234,721 234,721 Net (loss) and income $ (3,145,500) $ (441,074) $ 761,885 $ (2,824,689) Prescription Medical For the Six Months Ended June 30, 2023 Medications Devices Corporate Consolidated Net sales $ 2,490,686 $ 2,021,297 $ — $ 4,511,983 Cost of goods sold 257,721 806,878 — 1,064,599 Selling, general and administrative expenses 754,993 905,442 2,719,796 4,380,231 Research and development expenses 1,130,338 55,330 — 1,185,668 Depreciation and amortization expense 1,150,939 502,651 — 1,653,590 Interest income — — (119,241) (119,241) Interest expense — — 278,966 278,966 Net loss $ (803,305) $ (249,004) $ (2,879,521) $ (3,931,830) Prescription Medical For the Three Months Ended June 30, 2024 Medications Devices Corporate Consolidated Net sales $ 615,022 $ 806,449 $ — $ 1,421,471 Cost of goods sold 69,971 259,139 — 329,110 Selling, general and administrative expenses 625,030 569,782 1,091,818 2,286,630 Research and development expenses 368,978 — — 368,798 Depreciation and amortization expense 500,305 217,533 — 717,838 Change in fair value of derivative liability — — (1,614,000) (1,614,000) Interest income — — (119,391) (119,391) Interest expense — — 114,512 114,512 Net loss $ (949,082) $ (240,005) $ 527,061 $ (662,026) Prescription Medical For the Three Months Ended June 30, 2023 Medications Devices Corporate Consolidated Net sales $ 984,408 $ 1,009,603 $ — $ 1,994,011 Cost of goods sold 83,451 430,406 — 513,857 Selling, general and administrative expenses 258,145 481,572 1,509,875 2,249,592 Research and development expenses 865,122 1,453 — 866,575 Depreciation and amortization expense 575,470 251,325 — 826,795 Interest income — — (52,924) (52,924) Interest expense — — 136,799 136,799 Net loss $ (797,780) $ (155,153) $ (1,593,750) $ (2,546,683) |
Schedule of net sales by geographic region | For the Three Months Ended For the Six Months Ended June 30, June 30, Net sales 2024 2023 2024 2023 United States $ 1,105,433 $ 1,597,829 $ 2,284,277 $ 3,756,599 International 316,038 396,182 525,999 755,384 $ 1,421,471 $ 1,994,011 $ 2,810,276 $ 4,511,983 |
Schedule 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 June 30, 2024, are summarized as follows: Prescription Medical Medications Devices Consolidated Intangible assets, net $ 3,908,249 $ 3,632,922 $ 7,541,171 Total segment assets $ 19,705,255 $ 5,464,019 $ 25,169,274 The Company’s assets by reportable segment and reconciliation of segment assets to consolidated assets as of December 31, 2023, are summarized as follows: Prescription Medical Medications Devices Consolidated Intangible assets, net $ 4,903,749 $ 4,067,988 $ 8,971,737 Total segment assets $ 27,891,180 $ 5,904,615 $ 33,795,795 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Fair Value Measurements | |
Schedule of fair value of financial liabilities on recurring basis | June 30, Description Level 2024 Liabilities: Bifurcated embedded derivative liability 3 $ 202,000 |
Summary of the change in the fair value of financial liabilities | Balance on December 31, 2023 $ 3,550,000 Change in fair value of bifurcated embedded derivative (3,348,000) Balance on June 30, 2024 $ 202,000 |
Nature of Operations, Basis o_2
Nature of Operations, Basis of Presentation, Liquidity and Going Concern - Additional Information (Details) | 1 Months Ended | 6 Months Ended | |||
May 15, 2024 D | Jul. 31, 2023 USD ($) | Jun. 30, 2024 USD ($) | Dec. 31, 2023 USD ($) | Jan. 31, 2022 USD ($) | |
Nature of Operations, Basis of Presentation, Liquidity and Going Concern | |||||
Cash | $ 7,500,000 | ||||
Working capital | 4,000,000 | ||||
Accumulated deficit | (101,714,270) | $ (98,889,581) | |||
Principal amount of notes payable | 10,201,758 | ||||
Interest Amount | $ 7,600,000 | ||||
Proceeds from gross proceeds | $ 15,000,000 | ||||
Consecutive business days for maintaining bid price requirement | D | 30 | ||||
Vivus, Inc | Settlement Agreement | |||||
Nature of Operations, Basis of Presentation, Liquidity and Going Concern | |||||
Principal amount of notes payable | $ 10,201,758 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) $ in Millions | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) segment | Jun. 30, 2023 USD ($) | Dec. 31, 2023 USD ($) | |
Summary of Significant Accounting Policies | |||||
Number of operating segments | segment | 2 | ||||
Reserves for product returns | $ 4.9 | $ 4.9 | $ 4.2 | ||
Amount of returns | 0.3 | $ 0.4 | $ 0.8 | $ 0.8 | |
Revenue practical expedient, financing component | true | ||||
Deferred Revenue | 0 | $ 0 | 0.1 | ||
Prescription Medications | |||||
Summary of Significant Accounting Policies | |||||
Reserves for sales deductions | $ 5.1 | $ 5.1 | $ 4.7 | ||
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 ($) | Jun. 30, 2024 | Dec. 31, 2023 |
Accounts Receivable, net | ||
Gross accounts receivables | $ 2,099,868 | $ 2,887,317 |
Distribution service fees | (117,049) | (398,968) |
Chargebacks accrual | (5,983) | (2,462) |
Cash discount allowances | (22,979) | (24,639) |
Allowance for credit losses | (177,326) | (235,097) |
Total accounts receivable, net | $ 1,776,531 | $ 2,226,151 |
Accounts Receivable, net - Addi
Accounts Receivable, net - Additional information (Details) - customer | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Gross billings from customers | Customer concentration risk | |||||
Accounts Receivable, net | |||||
Number of customers | 3 | 3 | 3 | 4 | |
Gross billings from customers | Customer concentration risk | One customers | |||||
Accounts Receivable, net | |||||
Concentration risk percentage | 28% | 24% | 27% | 23% | |
Gross billings from customers | Customer concentration risk | Two customers | |||||
Accounts Receivable, net | |||||
Concentration risk percentage | 25% | 19% | 25% | 18% | |
Gross billings from customers | Customer concentration risk | Three customers | |||||
Accounts Receivable, net | |||||
Concentration risk percentage | 12% | 16% | 14% | 17% | |
Gross billings from customers | Customer concentration risk | Four customers | |||||
Accounts Receivable, net | |||||
Concentration risk percentage | 10% | ||||
Account receivables | Credit concentration risk | |||||
Accounts Receivable, net | |||||
Number of customers | 3 | 3 | |||
Account receivables | Credit concentration risk | One customers | |||||
Accounts Receivable, net | |||||
Concentration risk percentage | 28% | 35% | |||
Account receivables | Credit concentration risk | Two customers | |||||
Accounts Receivable, net | |||||
Concentration risk percentage | 25% | 22% | |||
Account receivables | Credit concentration risk | Three customers | |||||
Accounts Receivable, net | |||||
Concentration risk percentage | 22% | 18% |
Inventories (Details)
Inventories (Details) - USD ($) | Jun. 30, 2024 | Dec. 31, 2023 |
Inventories | ||
Raw Materials | $ 1,321,107 | $ 1,430,139 |
Finished goods | 112,110 | 180,252 |
Total inventory | $ 1,433,217 | $ 1,610,391 |
Inventories - Additional Inform
Inventories - Additional Information (Details) - USD ($) | Jun. 30, 2024 | Dec. 31, 2023 |
Inventories | ||
Finished goods are net of valuation reserves | $ 303,410 | $ 295,411 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets (Details) - USD ($) | Jun. 30, 2024 | Dec. 31, 2023 |
Prepaid Expenses and Other Current Assets. | ||
Prepaid insurance | $ 128,319 | $ 45,664 |
Prepaid FDA fees | 312,551 | 937,652 |
API purchase commitment asset (see Note 13) | 1,180,283 | 704,729 |
Other prepaid expenses | 187,263 | 234,459 |
Other current assets | 86,547 | 111,476 |
Total prepaid expenses and other current assets | $ 1,894,963 | $ 2,033,980 |
Intangible Assets (Details)
Intangible Assets (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Intangible Assets | |||||
Balance | $ 8,971,737 | $ 12,244,484 | $ 12,244,484 | ||
Amortization expense | $ (700,000) | $ (800,000) | (1,430,566) | $ (1,600,000) | (3,272,747) |
Balance | $ 7,541,171 | $ 7,541,171 | $ 8,971,737 |
Intangible Assets - Future annu
Intangible Assets - Future annual amortization (Details) - USD ($) | Jun. 30, 2024 | Dec. 31, 2023 | Dec. 31, 2022 |
Intangible Assets | |||
2024 (remaining 6 months) | $ 1,370,058 | ||
2025 | 1,754,329 | ||
2026 | 1,442,186 | ||
2027 | 1,212,871 | ||
2028 | 996,636 | ||
Thereafter | 765,091 | ||
Total | $ 7,541,171 | $ 8,971,737 | $ 12,244,484 |
Intangible Assets - Additional
Intangible Assets - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Intangible Assets | ||||||
Carrying value of intangible assets | $ 7,541,171 | $ 7,541,171 | $ 8,971,737 | $ 12,244,484 | ||
Amortization expense | $ 700,000 | $ 800,000 | $ 1,430,566 | $ 1,600,000 | 3,272,747 | |
Stendra product | ||||||
Intangible Assets | ||||||
Estimated useful lives of intangible assets | 10 years | 10 years | ||||
Carrying value of intangible assets | $ 3,900,000 | $ 3,900,000 | 4,900,000 | |||
Timm Medical product | ||||||
Intangible Assets | ||||||
Estimated useful lives of intangible assets | 12 years | 12 years | ||||
Carrying value of intangible assets | $ 2,800,000 | $ 2,800,000 | 3,200,000 | |||
PTV product | ||||||
Intangible Assets | ||||||
Estimated useful lives of intangible assets | 12 years | 12 years | ||||
Carrying value of intangible assets | $ 800,000 | $ 800,000 | $ 900,000 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Jun. 30, 2024 | Dec. 31, 2023 |
Accrued Expenses | ||
Accrued product returns | $ 4,944,502 | $ 4,178,176 |
Accrued contract rebates | 48,552 | 128,562 |
Due to 3PL/Wholesalers | 62,284 | 75,727 |
Accrued bonuses | 964,418 | 665,184 |
Accrued professional fees | 15,000 | |
Accrued R&D fees | 601,952 | 100,668 |
Other accrued expenses | 51,883 | 196,760 |
Total accrued expenses | $ 6,673,591 | $ 5,360,077 |
Debt - Promissory Note (Details
Debt - Promissory Note (Details) - USD ($) | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Debt Instrument | |||
Principal amount of notes payable | $ 10,201,758 | ||
Note | |||
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% | ||
Repayments of notes payable | $ 500,000 | $ 1,000,000 | |
Principal balance | $ 7,600,000 | $ 8,000,000 |
Debt - Future minimum principal
Debt - Future minimum principal payments (Details) - Promissory note | Jun. 30, 2024 USD ($) |
Debt Instrument | |
2024 (remaining 6 months) | $ 776,759 |
2025 | 2,720,940 |
2026 | 3,264,351 |
2027 | 872,073 |
Total | 7,634,123 |
Less: current portion | (1,936,995) |
Promissory note, net of current portion | $ 5,697,128 |
Stockholders' Equity - Number o
Stockholders' Equity - Number of shares held (Details) | 1 Months Ended | 6 Months Ended | ||||
Jun. 21, 2024 shares | Feb. 29, 2024 shares | Jan. 05, 2024 USD ($) shares | Dec. 21, 2023 USD ($) installment | Dec. 31, 2023 shares | Jun. 30, 2024 USD ($) | |
Stockholders' Equity | ||||||
Common Stock issued for services (in shares) | shares | 348,711 | |||||
CorProminence, LLC | ||||||
Stockholders' Equity | ||||||
Issuance of common stock | $ | $ 200,000 | |||||
Number of installments | installment | 2 | |||||
Common Stock issued for services (in shares) | shares | 245,158 | 70,922 | ||||
Maxim Group LLC | ||||||
Stockholders' Equity | ||||||
Common Stock issued for services (in shares) | shares | 6,906 | |||||
Restricted common stock per month | $ | $ 10,000 | |||||
Accrued restricted common stock | $ | $ 50,000 |
Stock Options - Summary of stoc
Stock Options - Summary of stock options (Details) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2024 | Dec. 31, 2023 | |
Number of Shares | ||
Options outstanding at the beginning | 509,133 | |
Options outstanding at the end | 509,133 | 509,133 |
Options exercisable at the end | 454,600 | |
Weighted-Average Fair Value at Grant Date | ||
Options outstanding at the beginning (in dollars per share) | $ 4.75 | |
Options outstanding at the end (in dollars per share) | 4.75 | $ 4.75 |
Options exercisable at the end (in dollars per share) | $ 5.15 | |
Weighted-Average Remaining Contractual Term (Years) and Aggregate Intrinsic Value | ||
Options outstanding at the beginning (in years) | 9 years 2 months 23 days | 9 years 5 months 15 days |
Options outstanding and exercisable at the beginning (in dollars) | $ 66 | |
Options outstanding at the ending (in years) | 9 years 2 months 23 days | 9 years 5 months 15 days |
Options exercisable at the end (in years) | 8 years 10 months 24 days | |
Options outstanding at the end (in dollars) | $ 66 |
Stock Options - Additional Info
Stock Options - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Stock Options. | ||||
Stock-based compensation expense | $ 16,834 | $ 43,316 | $ 197,215 | $ 173,652 |
Unrecognized stock-based compensation expense | $ 0 | $ 0 |
Common Stock Warrants - Summary
Common Stock Warrants - Summary of warrants (Details) - $ / shares | 6 Months Ended | 12 Months Ended |
Jun. 30, 2024 | Dec. 31, 2023 | |
Number of Warrants | ||
Warrants outstanding at the beginning | 8,203,839 | |
Warrants expired in 2024 | (11,768) | |
Warrants outstanding and exercisable at the end | 8,192,071 | 8,203,839 |
Weighted Average Exercise Price | ||
Weighted-Average Exercise Price at the beginning (in dollars per share) | $ 14.93 | |
Warrants expired in 2024 (in dollars per share) | 261.18 | |
Weighted-Average Exercise Price at the ending (in dollars per share) | $ 14.57 | $ 14.93 |
Remaining Contractual Term | ||
Warrants outstanding (in years) | 3 years 9 months 18 days | 4 years 3 months 18 days |
Dilutive convertible securiti_3
Dilutive convertible securities - Potentially dilutive securities convertible into common shares that were excluded from the calculation of diluted net income (loss) per share (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Basic and Diluted Net Loss per Common Share | ||||
Total | 10,739,395 | 1,214,182 | 10,739,395 | 1,214,182 |
Stock Options | ||||
Basic and Diluted Net Loss per Common Share | ||||
Total | 509,133 | 210,067 | 509,133 | 210,067 |
Series A Convertible Preferred stock | ||||
Basic and Diluted Net Loss per Common Share | ||||
Total | 2,038,191 | 2,038,191 | ||
Warrants | ||||
Basic and Diluted Net Loss per Common Share | ||||
Total | 8,192,071 | 1,004,115 | 8,192,071 | 1,004,115 |
Marketing, Licensing and Dist_2
Marketing, Licensing and Distribution Agreements - Vivus (Details) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||||
Jan. 18, 2022 USD ($) | Sep. 30, 2016 USD ($) | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2023 USD ($) | Jan. 31, 2022 USD ($) | |
Marketing, Licensing and Distribution Agreements | |||||||||
Principal amount of notes payable | $ 10,201,758 | $ 10,201,758 | |||||||
Noncash decrease in API purchase commitment | $ 459,422 | ||||||||
API purchase commitment asset | 1,180,283 | 1,180,283 | $ 704,729 | ||||||
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 | 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 | $ 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 | 30,751 | $ 49,220 | $ 61,406 | $ 124,534 | |||||
Royalty receivable | 56,503 | ||||||||
License Agreement | MTPC | Accrued liabilities | |||||||||
Marketing, Licensing and Distribution Agreements | |||||||||
Royalty payable | 4,903 | $ 4,903 | |||||||
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 | ||||||||
Principal amount of notes payable | $ 10,201,758 | ||||||||
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 | ||||||||
Settlement Agreement | Vivus, Inc | Other Current Assets | |||||||||
Marketing, Licensing and Distribution Agreements | |||||||||
API purchase commitment asset | 1,200,000 | $ 1,200,000 | 700,000 | ||||||
Settlement Agreement | Vivus, Inc | Other Noncurrent Assets | |||||||||
Marketing, Licensing and Distribution Agreements | |||||||||
Accrued inventory purchases, other assets | $ 3,500,000 | $ 3,500,000 | $ 4,200,000 | ||||||
Settlement Agreement | Vivus, Inc | Promissory Note | |||||||||
Marketing, Licensing and Distribution Agreements | |||||||||
Prepayment amount | 900,000 | ||||||||
Principal amount of notes payable | $ 10,201,758 |
Commitments and Contingencies (
Commitments and Contingencies (Details) $ in Millions | Jun. 30, 2024 USD ($) |
Commitments and Contingencies | |
Percentage Of Project work completed | 82% |
Contract Research Organization (CRO) | |
Commitments and Contingencies | |
Amount paid for Research contract | $ 1.4 |
Segment Information (Details)
Segment Information (Details) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) segment | Jun. 30, 2023 USD ($) | |
Statements | ||||
Number of operating segments | segment | 2 | |||
Results of operations by reportable segment | ||||
Net sales | $ 1,421,471 | $ 1,994,011 | $ 2,810,276 | $ 4,511,983 |
Cost of goods sold | 329,110 | 513,857 | 660,939 | 1,064,599 |
Selling, general and administrative expenses | 2,286,630 | 2,249,592 | 4,998,088 | 4,380,231 |
Research and development expenses | 368,798 | 866,575 | 1,924,750 | 1,185,668 |
Depreciation and amortization expense | 717,838 | 826,795 | 1,435,677 | 1,653,590 |
Derivative liability | (1,614,000) | (3,348,000) | ||
Interest income | (119,391) | (52,924) | (271,210) | (119,241) |
Interest expense | 114,512 | 136,799 | 234,721 | 278,966 |
Net Income (Loss) | (662,026) | (2,546,683) | $ (2,824,689) | (3,931,830) |
Operating segments | ||||
Statements | ||||
Number of operating segments | segment | 2 | |||
Corporate | ||||
Results of operations by reportable segment | ||||
Selling, general and administrative expenses | 1,091,818 | 1,509,875 | $ 2,622,604 | 2,719,796 |
Derivative liability | (1,614,000) | (3,348,000) | ||
Interest income | (119,391) | (52,924) | (271,210) | (119,241) |
Interest expense | 114,512 | 136,799 | 234,721 | 278,966 |
Net Income (Loss) | 527,061 | (1,593,750) | 761,885 | (2,879,521) |
Prescription Medications | Operating segments | ||||
Results of operations by reportable segment | ||||
Net sales | 615,022 | 984,408 | 1,228,115 | 2,490,686 |
Cost of goods sold | 69,971 | 83,451 | 145,327 | 257,721 |
Selling, general and administrative expenses | 625,030 | 258,145 | 1,302,928 | 754,993 |
Research and development expenses | 368,978 | 865,122 | 1,924,750 | 1,130,338 |
Depreciation and amortization expense | 500,305 | 575,470 | 1,000,610 | 1,150,939 |
Net Income (Loss) | (949,082) | (797,780) | (3,145,500) | (803,305) |
Medical Devices | Operating segments | ||||
Results of operations by reportable segment | ||||
Net sales | 806,449 | 1,009,603 | 1,582,161 | 2,021,297 |
Cost of goods sold | 259,139 | 430,406 | 515,612 | 806,878 |
Selling, general and administrative expenses | 569,782 | 481,572 | 1,072,556 | 905,442 |
Research and development expenses | 1,453 | 55,330 | ||
Depreciation and amortization expense | 217,533 | 251,325 | 435,067 | 502,651 |
Net Income (Loss) | $ (240,005) | $ (155,153) | $ (441,074) | $ (249,004) |
Segment Information - Net Sales
Segment Information - Net Sales by Geographic region (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Statements | ||||
Net sales | $ 1,421,471 | $ 1,994,011 | $ 2,810,276 | $ 4,511,983 |
United States | ||||
Statements | ||||
Net sales | 1,105,433 | 1,597,829 | 2,284,277 | 3,756,599 |
International | ||||
Statements | ||||
Net sales | $ 316,038 | $ 396,182 | $ 525,999 | $ 755,384 |
Segment Information - Segment a
Segment Information - Segment assets (Details) - USD ($) | Jun. 30, 2024 | Dec. 31, 2023 |
Statements | ||
Intangible assets, net | $ 7,541,171 | $ 8,971,737 |
Total segment assets | 25,169,274 | 33,795,795 |
Prescription Medications | ||
Statements | ||
Intangible assets, net | 3,908,249 | 4,903,749 |
Total segment assets | 19,705,255 | 27,891,180 |
Medical Devices | ||
Statements | ||
Intangible assets, net | 3,632,922 | 4,067,988 |
Total segment assets | $ 5,464,019 | $ 5,904,615 |
Private Placement (Details)
Private Placement (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |
Jul. 13, 2023 USD ($) installment $ / shares shares | Dec. 31, 2023 $ / shares shares | Jun. 30, 2024 USD ($) Y $ / shares shares | Jun. 30, 2024 USD ($) Y $ / shares shares | |
Private Placement | ||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | |
Exercise price of warrants | $ / shares | $ 2.25 | $ 14.93 | $ 14.57 | $ 14.57 |
Common Stock issued for services (in shares) | shares | 348,711 | |||
Aggregate common shares in percent | 5% | |||
Embedded Derivative Liability, Measurement Input | 0.205 | 0.205 | ||
Cash premium | $ 62,956 | $ 57,341 | ||
Preferred dividends at the stated dividend rate | 153,842 | 754,962 | ||
Dividends, Preferred Stock | 216,798 | 812,303 | ||
Reversal dividends payable of temporary equity at stated value | 57,341 | |||
Embedded derivative instrument | ||||
Private Placement | ||||
Fair value of the bifurcated embedded derivative | 202,000 | 202,000 | ||
Derivative, Gain on Derivative | $ 1,614,000 | $ 3,348,000 | ||
Fair value of our common stock | ||||
Private Placement | ||||
Embedded Derivative Liability, Measurement Input | 0.46 | 0.46 | ||
Equity volatility | Embedded derivative instrument | ||||
Private Placement | ||||
Embedded Derivative Liability, Measurement Input | 1.050 | 1.050 | ||
Traded volume volatility | ||||
Private Placement | ||||
Embedded Derivative Liability, Measurement Input | 2.350 | 2.350 | ||
Expected term | ||||
Private Placement | ||||
Embedded Derivative Liability, Measurement Input | Y | 0.42 | 0.42 | ||
Risk-free interest rate | ||||
Private Placement | ||||
Embedded Derivative Liability, Measurement Input | 0.0538 | 0.0538 | ||
Dividend yield | ||||
Private Placement | ||||
Embedded Derivative Liability, Measurement Input | 0.080 | 0.080 | ||
Penalty dividend rate | ||||
Private Placement | ||||
Embedded Derivative Liability, Measurement Input | 0.150 | 0.150 | ||
Probability of default | ||||
Private Placement | ||||
Embedded Derivative Liability, Measurement Input | 0.056 | 0.056 | ||
Series A Preferred Stock | ||||
Private Placement | ||||
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% | |||
Cash payable to investors | $ 224,124 | $ 224,124 | ||
Stated value of the Series A Preferred Shares | 188,953 | 188,953 | ||
Accrued dividends payable | $ 20,505 | 20,505 | ||
Cash premium | $ 14,666 | |||
Number of stock redeemed | shares | 1,624 | 5,983 | ||
Amount of stock redeemed for cash | $ 1,578,550 | $ 2,699,960 | ||
Number of common stock issued upon conversion | shares | 2,170,516 | 5,983,175 | ||
Value of common stock issued for conversion | $ 901,789 | $ 6,353,890 | ||
Reversal dividends payable of temporary equity at stated value | $ 62,956 | |||
Purchase Agreement | Private Placement | ||||
Private Placement | ||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | |||
Purchase Agreement | Series A Preferred Stock | ||||
Private Placement | ||||
Initial conversion price | $ / shares | $ 2.25 | $ 2.25 | $ 2.25 | |
Purchase Agreement | Series A Preferred Stock | Private Placement | ||||
Private Placement | ||||
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 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) | Jun. 30, 2024 USD ($) |
Level 3 | Bifurcated embedded derivative liability | |
Fair Value Measurements | |
Total liabilities | $ 202,000 |
Fair Value Measurements - Chang
Fair Value Measurements - Change in the fair value of financial liabilities (Details) - Bifurcated embedded derivative liability | 6 Months Ended |
Jun. 30, 2024 USD ($) | |
Change in the fair value of financial liabilities | |
Balance on December 31, 2023 | $ 3,550,000 |
Change in fair value of bifurcated embedded derivative | (3,348,000) |
Balance on March 31, 2024 | $ 202,000 |