Management's Discussion and Analysis of Financial Condition and Results of Operations ("MD&A") is designed to provide a reader of Petros' financial statements with a narrative from the perspective of management on the Company's financial condition, results of operations, liquidity and certain other factors that may affect future results. In certain instances, references are made to relevant sections of the Notes to Condensed Consolidated Financial Statements to direct the reader to a further detailed discussion. This section should be read in conjunction with the Condensed Consolidated Financial Statements and Supplementary Data included in this Quarterly Report on Form 10-Q. This MD&A contains forward-looking statements reflecting Petros' current expectations, whose actual outcomes involve risks and uncertainties. Actual results and the timing of events may differ materially from those stated in or implied by these forward-looking statements due to a number of factors, including those discussed in the sections entitled "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" contained in this Quarterly Report on Form 10-Q and in our Annual Report on Form 10-K for the fiscal year endedDecember 31, 2020 .
Overview
Petros is a pharmaceutical company focused on men's health therapeutics, consisting of wholly owned subsidiaries,Metuchen Pharmaceuticals, LLC ("Metuchen"),TIMM Medical Technologies, Inc. ("Timm Medical"), andPos-T-Vac, LLC ("PTV"). OnSeptember 30, 2016 , the Company entered into a License and Commercialization Agreement (the "License Agreement") withVivus, Inc ("Vivus") to purchase and receive the license for the commercialization and development of Stendra® for a one-time fee of$70 million . The License Agreement gives the Company the right to sell Stendra® in theU.S and its territories,Canada ,South America , andIndia . Stendra® is aU.S. Food and Drug Administration ("FDA") approved PDE-5 inhibitor prescription medication for the treatment of erectile dysfunction ("ED") and is the only patent protected PDE-5 inhibitor on the market. Stendra® offers the ED therapeutic landscape a valuable addition as an oral ED therapy that may be taken as early as approximately 15 minutes prior to sexual engagement, with or without food when using the 100mg or 200mg dosing (does not apply to 50mg dosing). Metuchen was founded byJoseph J. Krivulka , an experienced pharmaceutical executivewho held several key leadership positions at leading pharmaceutical companies such asMylan Laboratories Inc. and its subsidiaryBertek Inc. , and was also the co-founder ofReliant Pharmaceuticals , which was sold to GlaxoSmithKline in 2007 for$1.65 billion . During the period from Metuchen's inception in 2016 through 2018, the founder decided to outsource the sales and marketing function to an affiliated contractor. The level of performance expected from this affiliated contractor was not realized. In 2018, the founder passed away which caused significant disruption to the business. In 2019, Metuchen terminated the relationship with this affiliate contractor and established its own internal sales, marketing, and trade distribution functions for Stendra®. Also in 2019, Metuchen deployed a specialized key account sales model augmented by a national non-personal promotion campaign reaching nearly 30,000 healthcare professionals. Metuchen also enhanced its digital campaigns designed to create awareness among patients and its partners. Additionally, Metuchen engaged in a wide array of specialty medical conferences including presentations at educational product theaters and launched a national savings coupon for enhanced product access. Metuchen believes that these activities have established a framework for growth. Following a year of internal management of marketing, sales, and trade distribution functions, we believe the Company is well-positioned for a strong, multi-channel sales and marketing campaign. In addition to ED products, Petros is committed to identifying and developing other pharmaceuticals to advance men's health. InMarch 2020 , Petros acquired an exclusive global license (the "Hybrid License") for the development and commercialization of H100™ fromHybrid Medical LLC ("Hybrid"). H100™ is a novel and patented topical formulation candidate for the treatment of acute Peyronie's disease. Peyronie's disease is a condition that occurs upon penile tissue disruption often caused by sexual activity or injury, healing into collagen-based scars that may ultimately harden and cause penile deformity. OnSeptember 24, 2020 , the Company and Hybrid entered into a letter agreement, pursuant to which the term of the license agreement was extended for an additional six months toMarch 24, 2021 . In consideration for the extension, the Company paid Hybrid$50,000 inOctober 2020 and an additional$100,000 inDecember 2020 . OnMarch 31, 2021 , the Company and Hybrid, entered into a second letter agreement, pursuant to which the parties agreed to extend the Second Period (as defined in the Hybrid License) for an additional six (6) months toSeptember 24, 2021 . Additionally, the Company agreed to pay Hybrid a one-time, non-creditable and non-refundable payment of$200,000 , which was paid within seven calendar days of entering into the agreement. OnSeptember 24, 2021 , the Company entered into an amendment to the license agreement in which the Company exercised its right not to terminate the Hybrid License even though orphan drug status had not yet been granted by the FDA. Along with this election, the Company paid Hybrid$150,000 onOctober 1, 2021 ,$200,000 onOctober 31, 2021 , and agreed to pay two (2) additional payments of$200,000 byDecember 1, 2021 , andDecember 31, 2021 . 30 Table of Contents Impact of COVID-19 InJanuary 2020 , theWorld Health Organization ("WHO") announced a global health emergency because of a new strain of coronavirus originating inWuhan, China ("COVID-19") and the risks to the international community. TheWHO declared COVID-19 a global pandemic onMarch 11, 2020 , and since that time many of the previously imposed restrictions and other measures which were instituted in response have been subsequently reduced or lifted. However, the COVID-19 pandemic remains highly unpredictable and dynamic, and its duration and extent continue to be dependent on various developments, such as the emergence of variants to the virus that may cause additional strains of COVID-19, the administration and ultimate effectiveness of vaccines, and the eventual timeline to achieve a sufficient level of herd immunity among the general population. Accordingly, the COVID-19 pandemic may continue to have negative effects on the health of theU.S. economy for the foreseeable future. The Company cannot reasonably estimate the length or severity of the impact that the COVID-19 pandemic, including the emergence of any new variants, such as the Delta variant, will have on its financial results, and the Company may experience a material adverse impact on its sales, results of operations, and cash flows in fiscal 2021 and thereafter. During 2020, government regulations and the voluntary business practices of the Company and prescribing physicians had prevented in-person visits by sales representatives to physicians' offices. The Company had taken steps to mitigate the negative impact on its businesses of such restrictions. InMarch 2020 , the Company reduced its sales representative head count to reflect the lack of in-person visits. The Company has maintained a core sales team which continued to contact physicians via telephone and videoconference as well as continuing to have webinars provided by the Company's key opinion leaders to other physicians and pharmacists. In response to the spread of COVID-19, inMarch 2020 , the Company closed its administrative offices and as ofSeptember 30, 2021 , they remain closed, with the Company's employees continuing their work remotely. The Company has selectively resumed in-person interactions by its customer-facing personnel in compliance with local and state restrictions. The Company also continues to engage with customers virtually as the Company seeks to continue to support healthcare professionals and patient care. However, the Company's ability to engage in personal interactions with physicians and customers remains limited, and it is unknown when the Company's offices will reopen, and these interactions will be fully resumed.
Nature of Operations and Basis of Presentation
Petros Pharmaceuticals, Inc. ("Petros" or the "Company") was organized as aDelaware corporation onMay 14, 2020 for the purpose of effecting the transactions contemplated by that certain Agreement and Plan of Merger, dated as ofMay 17, 2020 (the "Original Merger Agreement"), by and between Petros,Neurotrope, Inc. , aNevada corporation ("Neurotrope"), PM Merger Sub 1, LLC, aDelaware limited liability company and a wholly-owned subsidiary of Petros ("Merger Sub 1"), PN Merger Sub 2, Inc., aDelaware corporation and a wholly owned subsidiary of Petros ("Merger Sub 2"), andMetuchen Pharmaceuticals LLC , aDelaware limited liability company ("Metuchen"). OnJuly 23, 2020 , the parties to the Merger Agreement entered into the First Amendment to the Agreement and Plan of Merger and Reorganization (the "First Merger Agreement Amendment") and onSeptember 30, 2020 , the parties to the Original Merger Agreement entered into the Second Amendment to the Agreement and Plan of Merger and Reorganization (the "Second Merger Agreement Amendment" and, together with the Original Merger Agreement and the First Merger Agreement Amendment, the "Merger Agreement"). The Merger Agreement provided for (1) the merger of Merger Sub 1, with and into Metuchen, with Metuchen surviving as a wholly owned subsidiary of Petros (the "Metuchen Merger") and (2) the merger of Merger Sub 2 with and intoNeurotrope , withNeurotrope surviving as a wholly owned subsidiary of Petros (the "Neurotrope Merger" and together with the Metuchen Merger, the "Mergers"). As a result of the Mergers, Metuchen andNeurotrope became wholly owned subsidiaries of Petros, and Petros became a publicly traded corporation onDecember 1, 2020 . OnDecember 7, 2020 ,Neurotrope completed the spin-off of certain assets, whereby (i) any cash in excess of$20,000,000 , subject to adjustment as provided in the Merger Agreement, and all of the operating assets and liabilities ofNeurotrope not retained byNeurotrope in connection with the Mergers were contributed to Synaptogenix, Inc. (formerly known asNeurotrope Bioscience, Inc. and a wholly owned subsidiary ofNeurotrope prior to the spin-off), aDelaware corporation ("Synaptogenix") and (ii) holders of record ofNeurotrope common stock, par value$0.0001 per share,Neurotrope preferred stock, par value$0.001 per share and certain warrants as ofNovember 30, 2020 , received a pro rata distribution of common stock of Synaptogenix, resulting in a separate, independent publicly traded company. 31
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The Mergers were accounted for as a reverse recapitalization in accordance withU.S. GAAP. Metuchen was determined to be the accounting acquirer based on an analysis of the criteria outlined in the FASB's ASC No. 805, Business Combinations ("ASC 805"), and the facts and circumstances specific to the Mergers, including: (1) Metuchen Securityholders owned approximately 51.0% ofNeurotrope and Metuchen at closing of the equity securities of the combined company immediately following the closing of the transaction; (2) a majority of the board of directors of the combined company are composed of directors designated by Metuchen under the terms of the Mergers; and (3) a majority of the existing members of Metuchen's management are the management of the combined company. The net assets of Metuchen are stated at historical costs in the Company's Condensed Consolidated Financial Statements, with no goodwill or intangible assets recorded. Accordingly, the historical financial statements of Metuchen throughNovember 30, 2020 , became the Company's historical financial statements. These Condensed Consolidated Financial Statements include the results of Petros fromDecember 1, 2020 , the date the reverse recapitalization was consummated. The Company manages its operations through two segments. The Company's two segments, Prescription Medications and Medical Devices, focus on the treatment of male ED. The Prescription Medications segment consists primarily of Stendra®, which is sold generally inthe United States . Expenses related to the development of H100™, which is in the early stages of development and has not yet sought FDA approval to begin Phase 1 clinical trials, will be within the Prescription Medications segment. The Medical Devices segment consists primarily of vacuum erection devices, which are sold domestically and internationally.
Licensing and Distribution
The Company acquired the rights to Stendra® avanafil onSeptember 30, 2016 , when it entered into the License Agreement with Vivus to purchase and receive the license for the commercialization and exploitation of Stendra® avanafil for a one-time fee of$70 million . The License Agreement gives the Company the exclusive right to sell avanafil in theU.S. and its territories, as well asCanada ,South America , andIndia . InDecember 2000 , Vivus originally was granted the license fromMitsubishi Tanabe Pharma Corporation ("MTPC") to develop, market, and manufacture Stendra®. Stendra® was approved by the FDA inApril 2012 to treat male ED. The Company will pay MTPC a royalty of 5% on the first$500 million of net sales and 6% of net sales thereafter until the expiration of the applicable patent in a particular country. The last scheduled patent expiration is inApril 2025 . In consideration for the trademark assignment and the use of the trademarks associated with Stendra® 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 Stendra® 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 Stendra® in such territory. After the royalty period, 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 one-time$6 million milestone payment to be paid once$250 million in sales has been reached on the separate revenue stream of Stendra® during any calendar year. In connection with the License Agreement, the Company and Vivus also entered into a Supply Agreement on the effective date of the License Agreement, which has since been terminated, effective as ofSeptember 30, 2021 . The Supply Agreement stated that Vivus would initially manufacture, test, and supply the product to the Company or its designee, directly or through one or more third parties. In connection with the Supply Agreement, we and Vivus have been in negotiations to determine the amounts ultimately owed to Vivus, but we may be responsible for payments of approximately$20.7 million . The Company provided Vivus with notice of termination of the Supply Agreement onSeptember 30, 2019 , which became effective onSeptember 30, 2021 . The Company is currently negotiating with multiple contract manufacturers to manufacture and supply Stendra® and serve as potential replacements for Vivus. The Company intends to enter into a new supply agreement with one or more of these candidates in the near future and hopes to have an agreement in place by the end of the year. However, these negotiations are ongoing and there is no assurance that we will be able to enter into any new supply agreement with such potential vendors or that we will be able to do so at terms favorable to us in a timely manner. As ofNovember 15, 2021 , we believe that we have sufficient supplies of Stendra® to meet demand for the next 10 months. InDecember 2020 , Vivus obtained approval of an in-court prepackaged plan of reorganization, under whichIEH Biopharma LLC ("IEH") obtained 100% ownership of Vivus (the "Prepackaged Plan"), and IEH assumed VIVUS' contractual obligations under the Supply Agreement. The license agreement between MTPC and Vivus (the "MTPC License") contains certain termination rights that will allow MTPC to terminate the agreement if Vivus were to breach any of the terms of the MTPC License or become insolvent or 32
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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®. OnMarch 27, 2018 , the Company entered into a Sublicense Agreement with Acerus Pharmaceuticals Corporation ("Acerus") whereby the Company granted to Acerus an exclusive sublicense inCanada for, among other things, the development and commercialization of Stendra® avanafil for a one-time fee of$100,000 . The Company is entitled to receive an additional fee of$400,000 if Stendra® is approved by Canadian regulators, as well as commercial milestone payments and royalty fees of 12% of net sales. The agreement remains in effect. InAugust 2018 , the Company entered into the Acerus Supply Agreement, pursuant to which Acerus will purchase the product from the Company so long as the Acerus Sublicense Agreement remains in effect. InMarch 2020 , we entered into the Hybrid License for the development and commercialization of H100™ from Hybrid. H100™ is a topical candidate with at least one active ingredient and potentially a combination of ingredients responsible for the improvement of penile curvature during the acute phase of Peyronie's disease. We paid an initial license fee of$100,000 and additional payments of$250,000 , with additional annual milestone payments of$125,000 ,$150,000 , and$200,000 on each of the first, second and third anniversaries of the entry into the Hybrid License and$250,000 annual payments due thereafter. OnSeptember 24, 2020 , the Company and Hybrid entered into a letter agreement, pursuant to which the term of the license agreement was extended for an additional six months toMarch 24, 2021 . In consideration for the extension, the Company paid Hybrid$50,000 inOctober 2020 and an additional$100,000 inDecember 2020 . OnMarch 31, 2021 , the Company and Hybrid, entered into a second letter agreement, pursuant to which the parties agreed to extend the Second Period (as defined in the License Agreement) for an additional six (6) months toSeptember 24, 2021 . Additionally, the Company agreed to pay Hybrid a one-time, non-creditable and non-refundable payment of two hundred thousandU.S. Dollars ($200,000 ), which was paid within seven calendar days of entering into the agreement. OnSeptember 24, 2021 , the Company entered into an amendment to the license agreement in which the Company exercised its right not to terminate the Hybrid License even though orphan drug status had not yet been granted by the FDA. Along with this election, the Company paid Hybrid$150,000 onOctober 1, 2021 ,$200,000 onOctober 31, 2021 , and agreed to pay two (2) additional payments of$200,000 byDecember 1, 2021 , andDecember 31, 2021 .
Critical Accounting Policies and Estimates
The preparation of the condensed consolidated financial statements requires us to make assumptions, estimates and judgments that affect the reported amounts of assets and liabilities, the disclosures of contingent assets and liabilities as of the date of the condensed consolidated financial statements, and the reported amounts of revenues and expenses during the reporting periods. Certain of our more critical accounting policies require the application of significant judgment by management in selecting the appropriate assumptions for calculating financial estimates. By their nature, these judgments are subject to an inherent degree of uncertainty. On an ongoing basis, we evaluate our judgments, including but not limited to those related to revenue recognition, collectability of accounts receivable, inventory valuation and obsolescence, intangibles, income taxes, litigation, and contingencies. We use historical experience and other assumptions as the basis for our judgments and making these estimates. Because future events and their effects cannot be determined with precision, actual results could differ significantly from these estimates. Any changes in those estimates will be reflected in our condensed consolidated financial statements as they occur. While our significant accounting policies are more fully described in "Part I; Item 1. Financial Statements and Supplementary Data; Notes to Condensed Consolidated Financial Statements; Note 2. Summary of Significant Accounting Policies" in this Quarterly Report on Form 10-Q, we believe that the following accounting policies and estimates are most critical to a full understanding and evaluation of our reported financial results. The critical accounting policies addressed below reflect our most significant judgments and estimates used in the preparation of our condensed consolidated financial statements. We have reviewed these critical accounting policies with the Audit Committee of our Board of Directors.
Revenue Recognition
The Company recognizes revenue 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 either its prescription medication or 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 prescription medication or medical device, which is typically upon delivery. In determining the transaction price, a significant financing component does not exist since the timing from when the Company delivers either the prescription medication or medical device to when the customers pay for the product is typically less than one year. The Company records sales net of any variable consideration, including but not limited to discounts, rebates, returns, chargebacks, and 33 Table of Contents distribution fees. The Company uses the expected value method when estimating its variable consideration unless terms are specified within contracts. The identified variable consideration is recorded as a reduction of revenue at the time revenues from sales 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. The most significant sales deductions relate to returns, contract rebates, coupon redemptions, and distribution service fees ("DSA fees"). Our estimates are based on factors such as our direct and indirect customers' buying patterns and the estimated resulting contractual deduction rates, historical experience, specific known market events and estimated future trends, current contractual and statutory requirements, industry data, estimated customer inventory levels, current contract sales terms with our direct and indirect customers, and other competitive factors. Significant judgment and estimation are required in developing the foregoing and other relevant assumptions. Consistent with industry practice, the Company maintains a return policy that generally allows its customers to return either the prescription medication or medical device and receive credit for product. The provision for returns is based upon the Company's estimates for future returns and historical experience. The provision of returns is part of the variable consideration recorded at the time revenue is recognized.
Accounts Receivable
The Company extends credit to its customers in the normal course of business. Accounts receivable are recorded at the invoiced amount, net of chargebacks, DSA fees, and cash discounts. Management determines each allowance based on historical experience along with the present knowledge of potentially uncollectible accounts.
Inventory
Inventories consist of finished goods held for sale and raw materials. Inventories are stated at the lower of cost or net realizable value, with cost determined using the first-in, first-out method. Inventories are adjusted for excess and obsolescence. Evaluation of excess inventory includes such factors as expiry date, inventory turnover, and management's assessment of current product demand. Fair Value Measurements 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 an 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. In connection with the Mergers inDecember 2020 , each security holder of Metuchen received a liability classified earnout consideration to be paid in the form of Petros Common Stock. The Company estimated their fair value using a Monte Carlo Simulation approach. This fair value measurement is based on significant inputs not observable in the market and thus represents a Level 3 measurement within the fair value hierarchy. 34 Table of Contents Intangibles The Company accounts for recognized intangible assets at cost. Intangible assets with finite useful lives are amortized over the useful life which the assets are expected to contribute directly or indirectly to future cash flows. Intangible assets are amortized using an accelerated method based on the pattern in which the economic benefits of the assets are consumed. The Company reviews the carrying value and useful lives of its intangible assets with definite lives whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable or the period over which they should be amortized has changed. When indicators of impairment exist, the Company determines whether the estimated undiscounted sum of the future cash flows of such assets is less than their carrying amounts. If less, an impairment loss is recognized in the amount, if any, by which the carrying amount of such assets exceeds their respective fair values. The Company evaluates the remaining useful life of each intangible asset that is being amortized during each reporting period to determine whether events and circumstances warrant a revision to the remaining period of amortization. If the estimate of the intangible asset's remaining useful life has changed, the remaining carrying amount of the intangible asset is amortized prospectively over that revised remaining useful life.
Recent Accounting Pronouncements
For a discussion of recent accounting pronouncements, refer to Note 2. Summary of Significant Accounting Policies of the Notes to Condensed Consolidated Financial Statements, which is incorporated herein by reference.
35 Table of Contents Results of Operations The impact on our results of operations of the COVID-19 pandemic and related changes in economic conditions, including changes to consumer spending resulting from the rapid rise in local and national unemployment rates, are highly uncertain and, in many instances, outside of our control. The duration and severity of the direct and indirect effects of the pandemic continue to evolve and in ways that are difficult to anticipate. There are numerous uncertainties related to the COVID-19 pandemic that have impacted our ability to forecast our future operations as a company. The extent to which the COVID-19 pandemic, and the emergence of any new variants, will affect our business, financial position and operating results in the future cannot be predicted with certainty; however, any such impact could be material. The COVID-19 pandemic could also increase the degree to which our results, including the results of our business segments, fluctuate in the future.
Three Months Ended
The following table sets forth a summary of our statements of operations for the
three months ended
For the Three Months Ended September 30, 2021 2020 Net sales$ 2,145,169 $ 3,464,695 Cost of sales 319,158 981,903 Gross profit 1,826,011 2,482,792 Operating expenses: Selling, general and administrative 3,413,223
3,121,023
Research and development 280,576
36,828
Depreciation and amortization expense 1,728,829 1,661,362 Total operating expenses 5,422,628 4,819,213 Loss from operations (3,596,617) (2,336,421)
Change in fair value of derivative liability 1,970,000
-
Interest expense, senior debt (67,936)
(300,355)
Interest expense, related party term loans - (669,730) Loss before income taxes (1,694,553) (3,306,506) Income tax expense (benefit) 2,345 (6,143) Net loss$ (1,696,898) $ (3,300,363) Net Sales
Net sales for the three months ended
Net sales for the three months ended
For the three months ended
For the three months ended
36
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Prescription Medicines sales consist of sales of Stendra® in theU.S. for the treatment of male ED. Stendra® was primarily sold directly to four main customers, which collectively accounted for approximately 98% of Stendra® gross sales for the three months endedSeptember 30, 2021 . Individually, sales to the four main customers accounted for 47%, 19%, 16%, and 16% of Stendra® gross sales for the three months endedSeptember 30, 2021 . Medical Device sales consist of domestic and international sales of men's health products for the treatment of ED. The men's health products do not require a prescription and include Vacuum Erection Devices ("VEDs and related accessories"). Net sales were$1,319,526 or 38% lower during the three months endedSeptember 30, 2021 , then in the same period in 2020 consisting of a$1,212,860 decrease in the net sales of Stendra® and a$106,666 decrease in Medical Device Sales. The decrease in net sales of Stendra® was substantially the result of increased sales allowances to promote sales of the 50mg Stendra® due to the manufacturing delays of the 100mg Stendra®. This situation is expected to be resolved in the fourth quarter of 2021. The decrease in net sales for our Medical Devices segment was attributable to decreased demand in domestic sales and international sales of VED systems. Cost of Sales
Cost of sales for the three months ended
Cost of sales for the three months ended
Cost of sales for the Prescription Medicine segment for the three months endedSeptember 30, 2021 , consisted of 152% royalty expenses, which was partially offset by a net 32% favorable adjustment to the costs of Stendra® sales and inventory obsolescence reserves and a 20% favorable adjustment to the 3PL order fulfillment and shipping expenses.
Cost of sales for the Medical Device segment for the three months
Cost of sales decreased by$662,745 or 68% during the three months endedSeptember 30, 2021 , compared to the same period in 2020. For the three months endedSeptember 30, 2021 , and 2020, cost of sales as a percentage of net sales was 15% and 28%, respectively. The decrease in cost of sales as a percentage of net sales was a result of decreased sales order fulfillment costs (on a per unit basis) during the three months endedSeptember 30, 2021 , and decreased amortization expense due to the inventory step-up asset being fully amortized inSeptember 2020 . Gross Profit
Gross profit for the three months endedSeptember 30, 2021 , was$1,826,011 or 85%, composed of$1,332,036 of gross profit from Prescription Medicines and$493,974 from Medical Devices. Gross profit for the three months endedSeptember 30, 2020 , was$2,482,792 or 72%, composed of$1,840,576 of gross profit from Prescription Medicines and$642,216 from Medical Devices. The changes in gross profit were driven by the factors noted above.
Operating Expenses
Selling, general and administrative
Selling, general and administrative expenses for the three months endedSeptember 30, 2021 , were$3,413,223 , composed of$1,318,610 of selling, general and administrative expenses of our Prescription Medicines segment,$722,998 of selling, general and administrative expenses of our Medical Devices segment and$1,371,615 of general corporate expenses. Selling, general and administrative expenses for the three months endedSeptember 30, 2020 , were$3,121,023 , composed of$1,837,864 of selling, general and administrative expenses of our Prescription Medicines segment,$566,666 of selling, general and administrative expenses of our Medical Devices segment and$716,493 of general corporate expenses. 37
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Selling, general and administrative expenses for both segments include selling, marketing, and regulatory expenses. Unallocated general corporate expenses include costs that were not specific to a particular segment but are general to the group, including expenses incurred for administrative and accounting staff, general liability and other insurance, professional fees, and other similar corporate expenses. Selling, general and administrative expenses increased by$292,200 or 9.4% during the three months endedSeptember 30, 2021 , compared to the same period in 2020. Increased selling general and administrative expenses were primarily driven by increased expenses associated with accounting, advisory, insurance, and investor relation services, which the Company did not incur in the prior period as a private company, partially offset by lower payroll expenses and direct marketing expenses as management sought to reduce expenses to improve operational efficiencies. Research and development
Research and development expenses for the three months ended
Research and development expenses for Prescription Medicines segment are
composed of
Research and development expenses for the three months endedSeptember 30, 2020 , were$36,828 , in our Prescription Medicines segment. Research and development expenses for Prescription Medicines segment are composed of$7,790 for consulting fees and$29 , 038 for legal fees related to the H100 license acquired inMarch 2020 . Research and development expenses increased by$243,748 or 662% during the three months endedSeptember 30, 2021 , compared to the same period in 2020. Increased research and development expenses were primarily driven by increased consulting fees related to the Company's Non-Prescription / Over-The-Counter ("OTC") Strategies and increased legal fees related to the H100 license acquired inMarch 2020 partially offset by decreased consulting fees related to the H100 license acquired inMarch 2020 .
Depreciation and amortization
Depreciation and amortization expenses for the three months endedSeptember 30, 2021 , were$1,728,829 , composed of$1,398,270 of depreciation and amortization expenses of our Prescription Medicines segment and$330,559 of depreciation and amortization expenses of our Medical Devices segment. Depreciation and amortization expenses for the three months endedSeptember 30, 2020 , were$1,661,362 , composed of$1,353,591 of depreciation and amortization expenses of our Prescription Medicines segment and$307,771 of depreciation and amortization expenses of our Medical Devices segment. Prescription Medicines depreciation and amortization consists primarily of the amortization of the intangible assets related to Stendra® over its estimated useful life of 10 years. Medical Devices depreciation and amortization primarily consists of the amortization of the intangible assets related to Timm Medical and PTV over their estimated useful life of 12 years.
Change in fair value of derivative liability
In connection with the Mergers consummated onDecember 1, 2020 , each security holder of Metuchen received a liability classified earnout consideration to be paid in the form of Petros Common Stock if either Petros' Market Capitalization (as defined in the Merger Agreement) or Petros receives aggregate gross proceeds from securities offerings that equals or exceeds certain milestones set forth in the Merger Agreement. The earnout contingent consideration met the criteria to be classified as a derivative with fair value remeasurements recorded in earnings each reporting period. As a result, the$1,970,000 represents the change in fair value of the derivative during the three months endedSeptember 30, 2021 , primarily driven by the decline in the Company's stock price as well as the passage of time. 38 Table of Contents
Interest expense, senior debt
Interest expense, senior debt for the three months endedSeptember 30, 2021 , was$67,936 , consisting of interest payments on our senior debt, with a weighted average balance of$2,305,470 . Interest expense, senior debt for the three months endedSeptember 30, 2020 , was$300,355 , consisting of interest payments on our senior debt, with a weighted average balance of$8,696,030 . The decrease of$232,419 or 77% was due to the pay down of$6.4 million of senior debt and unchanged weighted average interest rate subsequent toSeptember 30, 2020 .
Interest expense, subordinated related party term loans
There was no interest expense, subordinated related party term loans for the three months endedSeptember 30, 2021 . During 2020, the Company borrowed additional subordinated related party term loans in aggregate principal amount of$15.5 million . The subordinated related party term loans were converted into shares of the Company's common stock with the consummation of the Mergers onDecember 1, 2020 . Accordingly, there was no principal balance of the subordinated related party term loans or accrued PIK interest as ofSeptember 30, 2021 .
Income tax expense (benefit)
There was a$2,345 income tax expense for the three months endedSeptember 30, 2021 , as compared to a$6,143 income tax benefit for the three months endedSeptember 30, 2020 . The income tax expense was primarily attributed to the operations of the Medical Device segment, specifically Timm Medical, which is now included in the Company's consolidated group.
Nine Months Ended
The following table sets forth a summary of our statements of operations for the
nine months ended
For the Nine Months Ended September 30, 2021 2020 Net sales$ 8,678,424 $ 6,630,180 Cost of sales 1,355,838 2,305,169 Gross profit 7,322,586 4,325,011 Operating expenses: Selling, general and administrative 11,411,113
11,997,185
Research and development 799,803
307,796
Depreciation and amortization expense 5,186,486 4,984,084 Total operating expenses 17,397,402 17,289,065 Loss from operations (10,074,816) (12,964,054)
Change in fair value of derivative liability 9,640,000
-
Interest expense, senior debt (356,873)
(1,085,347)
Interest expense, related party term loans -
(1,148,447)
Loss before income taxes (791,689)
(15,197,848)
Income tax expense (benefit) 9,045 (49,895) Net loss$ (800,734) $ (15,197,953) Net Sales
Net sales for the nine months ended
39
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Net sales for the nine months ended
For the nine months ended
For the nine months ended
Prescription Medicines sales consist of sales of Stendra® in theU.S. for the treatment of male ED. Stendra® was primarily sold directly to five main customers, which collectively accounted for approximately 98% of Stendra® gross sales for the nine months endedSeptember 30, 2021 . Individually, sales to the five main customers accounted for 34%, 28%, 14%, 12% and 11% of Stendra® gross sales for the nine months endedSeptember 30, 2021 . Medical Device sales consist of domestic and international sales of men's health products for the treatment of ED. The men's health products do not require a prescription and include Vacuum Erection Devices ("VEDs and related accessories"). Net sales were$2,048,244 or 31% higher during the nine months endedSeptember 30, 2021 , than in the same period in 2020 consisting of a$2,099,060 increase in the net sales of Stendra® and a$50,815 decrease in Medical Device Sales. The increase in net sales of Stendra® was substantially due to higher wholesaler demand as the market began to recover from the implications of the 2019 FDA warning letter that impacted the Company's ability to promote Stendra® through the 3rd quarter of 2020 and the continued recovery from the COVID-19 pandemic in 2021. The decrease in net sales for our Medical Devices segment was attributable to decreased demand in domestic sales of VED systems partially offset by increased demand in international sales of VED systems.
Cost of Sales
Cost of sales for the nine months endedSeptember 30, 2021 , were$1,355,838 , composed of$607,582 of cost of sales for our Prescription Medicines segment and$748,256 for our Medical Devices segment. Cost of sales for the nine months endedSeptember 30, 2020 , were$2,305,169 , composed of$1,527,169 of cost of sales for our Prescription Medicines segment and$778,000 for our Medical Devices segment. Cost of sales for the Prescription Medicine segment for the nine months endedSeptember 30, 2021 , consisted of 56% third-party product cost of sales, 50% royalty expenses and 9% 3PL order fulfillment and shipping expenses, which was partially offset by a 15% favorable adjustment to the inventory obsolescence reserves. Cost of sales for the Medical Device segment for the nine monthsSeptember 30, 2021 , consisted of 87% raw materials, 10% production labor and 2% other cost of goods sold. Cost of sales decreased by$949,331 or 41% during the nine months endedSeptember 30, 2021 , compared to the same period in 2020. For the nine months endedSeptember 30, 2021 , and 2020, cost of sales as a percentage of net sales was 16% and 35%, respectively. The decrease in cost of sales as a percentage of net sales was a result of decreased sales order fulfillment costs (on a per unit basis) during the nine months endedSeptember 30, 2021 , and decreased amortization expense due to the inventory step-up asset being fully amortized inSeptember 2020 . Gross Profit
Gross profit for the nine months ended
40 Table of Contents Operating Expenses
Selling, general and administrative
Selling, general and administrative expenses for the nine months endedSeptember 30, 2021 , were$11,411,113 , composed of$4,985,603 of Selling, general and administrative expenses of our Prescription Medicines segment,$2,014,424 of Selling, general and administrative expenses of our Medical Devices segment and$4,411,086 of general corporate expenses. Selling, general and administrative expenses for the nine months endedSeptember 30, 2020 , were$11,997,185 , composed of$6,658,231 of selling, general and administrative expenses of our Prescription Medicines segment,$1,780,530 of selling, general and administrative expenses of our Medical Devices segment and$3,558,424 of general corporate expenses. Selling, general and administrative expenses for both segments include selling, marketing, and regulatory expenses. Unallocated general corporate expenses include costs that were not specific to a particular segment but are general to the group, including expenses incurred for administrative and accounting staff, general liability and other insurance, professional fees, and other similar corporate expenses. Selling, general and administrative expenses decreased by$586,072 or 5% during the nine months endedSeptember 30, 2021 , compared to the same period in 2020. Decreased selling general and administrative expenses were primarily driven by lower payroll expenses and direct marketing expenses as management sought to reduce expenses to improve operational efficiencies partially offset by increased expenses associated with accounting, advisory, insurance, and investor relation services, which the Company did not incur in the prior period as a private company.
Research and development
Research and development expenses for the nine months endedSeptember 30, 2021 , were$799,803 in our Prescription Medicines segment. Research and development expenses for Prescription Medicines segment are composed of$535,184 for consulting fees related to the Company's Non-Prescription/OTC Strategies and$200,000 for upfront licensing fees and$64,619 for legal fees related to the H100 license acquired inMarch 2020 . Research and development expenses for the nine months endedSeptember 30, 2020 , were$307,796 , in our Prescription Medicines segment. Research and development expenses for Prescription Medicines segment are composed of$13,875 for consulting fees related to the Company's Non-Prescription/OTC Strategies and$200,000 for upfront licensing fees,$51,180 for consulting fees and$42,741 for legal fees related to the H100 license acquired inMarch 2020 . Research and development expenses increased by$492,007 or 160% during the nine months endedSeptember 30, 2021 , compared to the same period in 2020. Increased research and development expenses were primarily driven by increased consulting fees related to the Company's Non-Prescription/OTC Strategies and increased legal fees related to the H100 license acquired inMarch 2020 partially offset by decreased consulting fees related to the H100 license acquired inMarch 2020 .
Depreciation and amortization
Depreciation and amortization expenses for the nine months endedSeptember 30, 2021 were$5,186,486 , composed of$4,194,809 of depreciation and amortization expenses of our Prescription Medicines segment and$991,677 of depreciation and amortization expenses of our Medical Devices segment. Depreciation and amortization expenses for the nine months endedSeptember 30, 2020 , were$4,984,084 , composed of$4,060,772 of depreciation and amortization expenses of our Prescription Medicines segment and$923,312 of depreciation and amortization expenses of our Medical Devices segment. Prescription Medicines depreciation and amortization consists primarily of the amortization of the intangible assets related to Stendra® over its estimated useful life of 10 years. Medical Devices depreciation and amortization primarily consists of the amortization of the intangible assets related to Timm Medical and PTV over their estimated useful life of 12 years. 41
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Change in fair value of derivative liability
In connection with the Mergers consummated onDecember 1, 2020 , each security holder of Metuchen received a liability classified earnout consideration to be paid in the form of Petros Common Stock if either Petros' Market Capitalization (as defined in the Merger Agreement) or Petros receives aggregate gross proceeds from securities offerings that equals or exceeds certain milestones set forth in the Merger Agreement. The earnout contingent consideration met the criteria to be classified as a derivative with fair value remeasurements recorded in earnings each reporting period. As a result, the$9,640,000 represents the change in fair value of the derivative during the nine months endedSeptember 30, 2021 , primarily driven by the decline in the Company's stock price as well as the passage of time.
Interest expense, senior debt
Interest expense, senior debt for the nine months endedSeptember 30, 2021 , was$356,873 , consisting of interest payments on our senior debt, with a weighted average balance of$3,958,927 . Interest expense, senior debt for the nine months endedSeptember 30, 2020 , was$1,085,347 , consisting of interest payments on our senior debt, with a weighted average balance of$10,204,922 . The decrease of$728,474 or 67% was due to the pay down of$6.4 million of senior debt and unchanged weighted average interest rate subsequent toSeptember 30, 2020 .
Interest expense, subordinated related party term loans
There was no interest expense, subordinated related party term loans for the nine months endedSeptember 30, 2021 . During 2020, the Company borrowed additional subordinated related party term loans in aggregate principal amount of$15.5 million . The subordinated related party term loans were converted into shares of the Company's common stock with the consummation of the Mergers onDecember 1, 2020 . Accordingly, there was no principal balance of the subordinated related party term loans or accrued PIK interest as ofSeptember 30, 2021 .
Income tax expense (benefit)
There was a$9,045 income tax expense for the nine months endedSeptember 30, 2021 , as compared to a$49,895 income tax benefit for the nine months endedSeptember 30, 2020 . The income tax expense was primarily attributed to the operations of the Medical Device segment, specifically Timm Medical, which is now included in the Company's consolidated group.
Liquidity and Capital Resources
General
Cash totaled
We have experienced net losses and negative cash flows from operations since our inception. As ofSeptember 30, 2021 , we had cash of$8.1 million , negative working capital of approximately$20.1 million , including debt of$1.7 million maturing in 2021, and sustained cumulative losses attributable to holders of common stock of$62.5 million . Our plans include, or may include, utilizing our cash and cash equivalents on hand, and our liability due to Vivus as well as exploring additional ways to raise capital in addition to increasing cash flows from operations. InOctober 2021 , the Company issued 3,323,616 shares of its common stock and received$5.5 million in net proceeds. InNovember 2021 , the Company repaid$1.2 million in full satisfaction of its senior debt. While we are optimistic that we will be successful in our efforts to achieve our plans, there can be no assurances that we will be successful in doing so. As such, we obtained a continued support letter from our largest shareholder, JCP III SMAIV, L.P. , throughNovember 16, 2022 . To date, our principal sources of capital used to fund our operations have been the net proceeds we received from the Mergers, revenues from product sales, private sales and registered offering of equity securities and proceeds received from the issuance of convertible debt, as described below. Our principal expenditures include payment for inventory of Stendra® from our key supplier, Vivus, including purchases of inventory accrued in current periods, but for which payment is due in future periods. We have significant unpaid balances owed to Vivus and are currently in discussions with Vivus with respect to amounts owed. We had an aggregate accrued unpaid balance owed to
Vivus of 42 Table of Contents$20,724,188 as ofSeptember 30, 2021 . While the Company is in discussions with Vivus to convert a portion of the amounts owed into a subordinated note, though there can be no assurance that we will be successful in these discussions. InMarch 2020 , the Company acquired the Hybrid License, providing an exclusive license to H100™. H100™ is a topical candidate with at least one active ingredient and potentially a combination of ingredients responsible for the improvement of penile curvature during the acute phase of Peyronie's disease. We paid an initial license fee of$100,000 and an additional payment of$250,000 and additional annual milestone payments of$125,000 ,$150,000 , and$200,000 are due on each of the first, second and third anniversaries of the license agreement and$250,000 annual payments due thereafter. The Company is also required to make a$1,000,000 payment upon first commercial sale and a sliding scale of percentage payments on net sales in the low single digits. Annual anniversary payments will not be required after commercialization. The Company is also obligated to make royalty payments between 3-6% of any net sales. OnSeptember 24, 2020 , the Company and Hybrid entered into a letter agreement, pursuant to which the term of the Hybrid License was extended for an additional six months toMarch 24, 2021 . In consideration for the extension, the Company paid Hybrid$50,000 inOctober 2020 and an additional$100,000 inDecember 2020 . OnMarch 31, 2021 , the Company and Hybrid, entered into a second letter agreement, pursuant to which the parties agreed to extend the Second Period (as defined in the Hybrid License) for an additional six (6) months toSeptember 24, 2021 . Additionally, the Company agreed to pay Hybrid a one-time, non-creditable and non-refundable payment of two hundred thousandU.S. Dollars ($200,000 ), which was paid within seven calendar days of entering into the second letter agreement. OnSeptember 24, 2021 , the Company entered into an amendment to the license agreement in which the Company exercised its right not to terminate the Hybrid License even though orphan drug status had not yet been granted by the FDA. Along with this election, the Company paid Hybrid$150,000 onOctober 1, 2021 ,$200,000 onOctober 31, 2021 , and agreed to pay two (2) additional payments of$200,000 byDecember 1, 2021 , andDecember 31, 2021 . The Company also expects to incur approximately$14 million of research and development expenses relating to H100™ over the estimated four to six-year period of clinical development prior to FDA approval, including approximately$10 million for clinical trials and$4 million of other expenses.
OnOctober 13, 2021 , the Company entered into a securities purchase agreement (the "Purchase Agreement") with certain accredited and institutional investors (the "Purchasers"). Pursuant to the Purchase Agreement, the Company agreed to sell in a registered direct offering (the "Registered Direct Offering") 3,323,616 shares (the "Shares") of the Company's common stock,$0.0001 par value per share (the "Common Stock"), to the Purchasers at an offering price of$1.715 per share and associated Investor Warrant (as defined herein). Pursuant to the Purchase Agreement, in a concurrent private placement (together with the Registered Direct Offering, the "Offerings"), the Company also agreed to sell to the Purchasers unregistered warrants (the "Investor Warrants") to purchase up to an aggregate of 3,323,616 shares of Common Stock, representing 100% of the shares of Common Stock to be purchased in the Registered Direct Offering (the "Warrant Shares"). The Investor Warrants are exercisable at an exercise price of$1.715 per share, are exercisable immediately upon issuance and have a term of exercise equal to five years from the date of issuance.
The Company received net proceeds from the sale of the Shares, after deducting
fees and other estimated offering expenses payable by the Company, of
approximately
Katalyst Securities LLC ("Katalyst") served as a financial advisor to the company pursuant to an advisory consulting agreement (the "Katalyst Agreement") entered into by the Company and Katalyst onOctober 13, 2021 . Pursuant to the Katalyst Agreement, the Company paid Katalyst an advisory fee and legal expenses totaling$0.2 million for its services as a financial advisor in connection with this offering. Additionally, the Company issued to Katalyst's representatives or designees warrants to purchase up to an aggregate of 130,000 shares of Common Stock (the "Katalyst Warrants") with the same terms as the Investor Warrants. We will require additional financing to further develop and market our products, fund operations, and otherwise implement our business strategy at amounts relatively consistent with the expenditure levels disclosed above. We are exploring additional ways to raise capital, but we cannot assure you that we will be able to raise capital. Our failure to raise capital as and when needed would have a material adverse impact on our financial condition, our ability to meet our obligations, and our ability to pursue our business strategies. We 43
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expect to seek additional funds through a variety of sources, which may include additional public or private equity or debt financings, collaborative, or other arrangements with corporate sources, or through other sources of financing. We are focused on expanding our service offering through internal development, collaborations, and through strategic acquisitions. We are continually evaluating potential asset acquisitions and business combinations. To finance such acquisitions, we might raise additional equity capital, incur additional debt, or both. Debt Senior Debt OnSeptember 30, 2016 , the Company entered into a loan and security agreement (the "Loan Agreement") with Hercules Capital, Inc. ("Hercules"), for a$35 million term loan. The Loan Agreement includes an additional Payable-In-Kind ("PIK") interest that increases the outstanding principal on a monthly basis at an annual rate of 1.35% and a$787,500 end of term charge. The end of term charge is being recognized as interest expense and accreted over the term of the Loan Agreement, as amended, using the effective interest method. We refer to the amounts available under the credit facility with Hercules as Senior Debt. OnNovember 22, 2017 , the Company entered into Amendment No. 1 to the Loan Agreement (the "First Amendment"). A covenant was added, in which the Company must achieve a certain minimum EBITDA, as defined in the First Amendment, target for the trailing twelve-month period, ending June,30, 2018. The end of term charge was increased from$787,500 to$1,068,750 . The minimum EBITDA for each of the trailing six months and the fixed charge coverage ratio were reduced from 1:1 to 0.9:1. The Company was also required to prepay$10 million in principle. EffectiveApril 13, 2020 , the Company and Hercules entered into Amendment No. 2 to the Loan Agreement, (the "Second Amendment"), to extend the maturity date thereof toApril 1, 2021 , subject to further extension toDecember 1, 2021 , if the Company raises at least$20 million through an equity or debt financing or other transaction. All previously accrued PIK interest was added to accrued principal, and no further PIK interest will accrue. The cash interest would accrue at a rate of the greater of (i) the prime rate reported in theWall Street Journal plus 11.50% minus 4.25% and (ii) 11.50%. The interest rate was 11.50% atSeptember 30, 2021 . The end of term charge of$1,068,750 was partially extended with$534,375 due onOctober 1, 2020 , and$534,375 due onFebruary 1, 2021 . The Company incurred a$50,000 amendment fee upon closing of the Second Amendment. EffectiveSeptember 30, 2020 , the Company and Hercules entered into the Amendment No. 3 to Loan Agreement (the "Third Amendment") to provide for interest only payments commencing onOctober 1, 2020 , and continuing throughDecember 22, 2020 , unless the Company raises net cash proceeds of at least$25 million through an equity or debt financing or other transaction on or beforeDecember 21, 2020 . The Third Amendment also amended the minimum cash, minimum net revenue, and minimum EBITDA financial covenants. On that same date,Juggernaut Capital Partners III, L.P. , an affiliate of the JCP Investor, Hercules, andWells Fargo Bank, N.A. entered into an escrow agreement (the "Escrow Agreement") to escrow certain funds in an aggregate amount equal to certain principal payments owed under the Loan Agreement, as amended. In connection with the consummation of the Mergers, the funds held in escrow were disbursed back toJuggernaut Capital Partners III, L.P. and the Escrow Agreement was terminated.
The Company satisfied the maturity date extension requirement pursuant to funds
retained upon the closing of the Mergers in
On
Subordinated Related Party Term Loans
During 2020, the Company entered into Subordinated Promissory Notes with the JCP Investor in the principal amount of$15.5 million . The maturity date of the Subordinated Promissory Notes wasApril 2, 2021 , and they had PIK interest that increases the outstanding principal on a daily basis at an annual rate of 20%. In connection with the entry into the Merger Agreement onMay 17, 2020 , the JCP Investor,Neurotrope and Metuchen entered into a Note Conversion and Loan Repayment Agreement pursuant to which, the JCP Investor agreed to convert all of the above outstanding subordinated promissory notes and accrued PIK interest of the Company held byJuggernaut Capital Partners LLP and the JCP Investor, 44
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into Petros common stock in connection with the consummation of the Mergers on
Cash Flows
The following table summarizes our cash flows for the nine months ended
For the Nine Months EndedSeptember 30, 2021 2020
Net cash used in operating activities$ (3,557,732) $ (10,782,430) Net cash used in investing activities -
(4,633)
Net cash (used in) provided by financing activities (5,446,778)
9,310,326 Net decrease in cash$ (9,004,510) $ (1,476,737)
Cash Flows from Operating Activities
Net cash used in operating activities for the nine months endedSeptember 30, 2021 , was$3,557,732 , which primarily reflected our net loss of$800,734 , partially offset by cash adjustments to reconcile net income to net cash used in operating activities of$3,131,046 consisting primarily of depreciation and amortization, inventory obsolescence reserves, changes in the fair value of derivative liability, and changes in operating assets and liabilities of$374,048 . Net cash used in operating activities for the nine months endedSeptember 30, 2020 , was$10,782,430 , which primarily reflected our net loss of$15,147,953 , partially offset by adjustments to reconcile net loss to net cash provided by operating activities of$6,637,657 consisting primarily of depreciation and amortization, non-cash paid-in-kind interest and amortization of deferred financing costs and debt discount, and changes in operating assets and liabilities of$2,272,134 .
Cash Flows from Investing Activities
Net cash used in investing activities was$4,633 for the nine months endedSeptember 30, 2020 , respectively, related to the acquisition of fixed assets. No cash was used in investing activities for the nine months endedSeptember 30, 2021 .
Cash Flows from Financing Activities
Net cash used in financing activities was$5,446,778 for the nine months endedSeptember 30, 2021 , consisting of payments of senior debt of$4,912,541 and a payment for the senior debt end-of-term fee of$534,237 . Net cash provided by financing activities was$9,310,326 for the nine months endedSeptember 30, 2020 , consisting of proceeds from issuance of subordinated related party term loans of$14,000,000 , partially offset by payments on the senior debt of$4,639,674 and debt issuance costs of$50,000 .
Off-Balance Sheet Commitments and Arrangements
We have not entered into any off-balance sheet financial guarantees or other off-balance sheet commitments to guarantee the payment obligations of any third parties. We have not entered into any derivative contracts that are indexed to our shares and classified as stockholder's equity or that are not reflected in our financial statements included as Exhibit 99.1 to this Form 10-Q. Furthermore, we do not have any retained or contingent interest in assets transferred to an unconsolidated entity that serves as credit, liquidity, or market risk support to such entity. We do not have any variable interest in any unconsolidated entity that provides financing, liquidity, market risk or credit support to us or engages in leasing, hedging or product development services with us. 45 Table of Contents Contingencies Certain conditions may exist as of the date the financial statements are issued, which may result in a loss to the Company, but which will only be resolved when one or more future events occur or fail to occur. The Company's management, in consultation with its legal counsel as appropriate, assesses such contingent liabilities, and such assessment inherently involves an exercise of judgment. In assessing loss contingencies related to legal proceedings that are pending against the Company or unasserted claims that may result in such proceedings, the Company, in consultation with legal counsel, evaluates the perceived merits of any legal proceedings or unasserted claims, as well as the perceived merits of the amount of relief sought or expected to be sought therein. If the assessment of a contingency indicates it is probable that a material loss has been incurred and the amount of the liability can be estimated, then the estimated liability would be accrued in the Company's financial statements. If the assessment indicates a potentially material loss contingency is not probable, but is reasonably possible, or is probable, but cannot be estimated, then the nature of the contingent liability, together with an estimate of the range of possible loss, if determinable and material, would be disclosed. Loss contingencies considered remote are generally not disclosed unless they involve guarantees, in which case the guarantees would be disclosed.
Reconciliation of Non-GAAP Financial Measures
Adjusted EBITDA
Adjusted EBITDA is a non-GAAP financial measure utilized by management to evaluate the Company's performance on a comparable basis. The Company believes that Adjusted EBITDA is useful to investors as a supplemental way to evaluate the ongoing operations of the Company's business as Adjusted EBITDA may enhance investors' ability to compare historical periods as it adjusts for the impact of financing methods, tax law and strategy changes, and depreciation and amortization and to evaluate the Company's ability to service debt. In addition, Adjusted EBITDA is a financial measurement that management and the Company's Board of Directors use in their financial and operational decision-making and in the determination of certain compensation programs. Adjusted EBITDA is a non-GAAP financial measure commonly used in the Company's industry and should not be construed as an alternative to net income as an indicator of operating performance (as determined in accordance with GAAP). The Company's presentation of Adjusted EBITDA may not be comparable to similarly titled measures reported by other companies. Adjusted EBITDA is adjusted to exclude certain items that affect comparability. The adjustments are itemized in the tables below. You are encouraged to evaluate these adjustments and the reason the Company considers them appropriate for supplemental analysis. In evaluating adjustments, you should be aware that in the future the Company may incur expenses that are the same as or similar to some of the adjustments set forth below. The presentation of these adjustments should not be construed as an inference that future results will be unaffected by unusual or recurring items. The Company defines Adjusted EBITDA as net income (loss) adjusted to exclude (i) interest expense, net, (ii) depreciation and amortization and (iii) income taxes, as further adjusted to eliminate the impact of certain items that the Company does not consider indicative of its ongoing operating performance or that are non-recurring in nature. For example, Adjusted EBITDA:
? does not reflect the Company's capital expenditures, future requirements for
capital expenditures or contractual commitments;
? does not reflect changes in, or cash requirements for, the Company's working
capital needs;
? does not reflect the significant interest expense, or the cash requirements
necessary to service interest or principal payments, on the Company's debt; and
? does not reflect payments related to income taxes, if applicable.
46 Table of Contents
The following table presents a reconciliation of Net loss to Adjusted EBITDA for
the three and nine months ended
For the Three Months Ended For the Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Net loss$ (1,696,898) $ (3,300,363) $ (800,734) $ (15,147,953) Interest expense, senior debt 67,936 300,355 356,873 1,085,347 Interest expense, related party term loans - 669,730 - 1,148,447 Income tax expense (benefit) 2,345 (6,143) 9,045 (49,895) Depreciation and amortization expense 1,728,829 1,661,362 5,186,486 4,984,084 EBITDA 102,212 (675,059) 4,751,670 (7,979,970) Change in fair value of derivative liability (1,970,000) - (9,640,000) - Adjusted EBITDA$ (1,867,788) $ (675,059) $ (4,888,330) $ (7,979,970)
Adjusted EBITDA has limitations as an analytical tool, and you should not consider it in isolation, or as a substitute for analysis of the Company's results as reported under GAAP.
Gross Billings
Gross billings is a non-GAAP financial measure utilized as a key performance metric by management and the Company's Board of Directors in their financial and operational decision-making as well as for the preparation of the annual budget. The Company believes that Gross billings is useful to investors as a supplemental way to provide an alternative measure of the total demand for the products sold by the Company. Gross billings is a non-GAAP financial measure commonly used in the Company's industry and should not be construed as an alternative to net sales as an indicator of operating performance (as determined in accordance with GAAP). The Company's presentation of gross billings may not be comparable to similarly titled measures reported by other companies. Gross billings is adjusted to exclude certain items that affect comparability. The adjustments are itemized in the tables below. You are encouraged to evaluate these adjustments and the reason the Company considers them appropriate for supplemental analysis. In evaluating adjustments, you should be aware that in the future the Company may incur expenses that are the same as or similar to some of the adjustments set forth below. The presentation of these adjustments should not be construed as an inference that future results will be unaffected by unusual or recurring items. The Company defines gross billings as the amount of its aggregate sales billed to customers at standard prices before the application of certain adjustments that reduce the net amount received from customers, including product returns, certain rebates and coupon redemptions, discounts, and fees.
The following table presents a reconciliation of net sales to gross billings for
the three and nine months ended
For the Three Months Ended For the Nine Months Ended September 30 September 30 2021 2020 2021 2020 Net Sales$ 2,145,169 $ 3,464,695 $ 8,678,424 $ 6,630,180 Product Returns 2,256,673 (118,298) 4,069,440 53,448 Contract Rebates 607,143 849,779 2,529,625 2,746,205 Chargebacks 4,748 146,117 270,094 1,167,142 Cash Discounts 79,722 73,398 346,656 200,600 Distribution Service Fees 540,618 425,349 1,486,590 1,319,370 Coupon Redemptions 2,896,935 582,346 4,821,786 1,802,705 Gross Billings$ 8,531,008 $ 5,423,386 $ 22,202,615 $ 13,919,650
Gross billings has limitations as an analytical tool, and you should not consider it in isolation, or as a substitute for analysis of the Company's results as reported under GAAP.
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