Petros Pharmaceuticals 10Q 2022 Q2 Quarterly report

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 10-Q

(Mark One)

☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

for the quarterly period ended June 30, 2022

☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

for the transition period from to

Commission File Number: 001-39752

Petros Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)


Delaware		85-1410058
(State of Incorporation)		(I. R. S. Employer Identification No.)

1185 Avenue of the Americas, 3rd Floor, New York, New York		10036
(Address of principal executive offices)		(Zip Code)

(973) 242-0005

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common stock, par value $0.0001	PTPI	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (section 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of August 10, 2022, there were 20,684,723 shares of the registrant’s common stock, par value $0.0001 per share, outstanding.

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CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q may contain or incorporate by reference forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Such forward-looking statements are based upon management’s assumptions, expectations, projections, intentions and beliefs about future events. Except for historical information, the use of predictive, future-tense or forward-looking words such as “intend,” “plan,” “predict,” “may,” “will,” “project,” “target,” “strategy,” “estimate,” “anticipate,” “believe,” “expect,” “continue,” “potential,” “forecast,” “should” and similar expressions, whether in the negative or affirmative, that reflect our current views with respect to future events and operational, economic and financial performance are intended to identify such forward-looking statements. Such forward-looking statements are only predictions, and actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of risks and uncertainties, including, without limitation, Petros’ ability to execute on its business strategy, including its plans to develop and commercialize its product candidates; Petros’ ability to comply with obligations as a public reporting company; the ability of Petros to timely and effectively implement controls and procedures required by Section 404 of the Sarbanes-Oxley Act of 2002; the risk that the financial performance of Petros may not be as anticipated by the merger transactions that resulted in the Company’s creation; risks resulting from Petros’ status as an emerging growth company, including that reduced disclosure requirements may make shares of Petros common stock less attractive to investors; risks related to Petros’ history of incurring significant losses; risks related to Petros’ dependence on the commercialization of a single product, Stendra®; risks related to Petros’ ability to obtain regulatory approvals for, or market acceptance of, any of its products or product candidates; and the expected or potential impact of the novel coronavirus (“COVID 19”) pandemic, including the emergence of new variants, such as the Omicron BA.5 variant, and the related responses of governments, consumers, customers, suppliers, employees and the Company, on our business, operations, employees, financial condition and results of operations. Additional factors that could cause actual results to differ materially from the results anticipated in these forward-looking statements are described in this Quarterly Report on Form 10-Q, in “Risk Factor Summary” and in Part I, Item 1A., “Risk Factors,” in Petros’ Annual Report on Form 10-K for the year ended December 31, 2021 and in our other reports filed with the Securities and Exchange Commission (the “SEC”). We advise you to carefully review the reports and documents we file from time to time with the SEC, particularly our annual reports on Form 10-K, our quarterly reports on Form 10-Q and our current reports on Form 8-K. Petros cautions readers that the forward-looking statements included in, or incorporated by reference into, this Quarterly Report on Form 10-Q represent our beliefs, expectations, estimates and assumptions only as of the date hereof and are not intended to give any assurance as to future results. New factors emerge from time to time, and it is not possible for us to predict all of these factors. Further, Petros cannot assess the effect of each such factor on our business or the extent to which any factor, or combination of factors, may cause actual results to be materially different from those contained in any forward-looking statement.

Readers are cautioned not to place undue reliance on forward-looking statements because of the risks and uncertainties related to them and to the risk factors. We disclaim any obligation to update the forward-looking statements contained in, or incorporated by reference into, this Quarterly Report on Form 10-Q to reflect any new information or future events or circumstances or otherwise, except as required by the federal securities laws.

OTHER INFORMATION

All references to “Petros,” the “Company,” “we,” “us” and “our” in this Quarterly Report on Form 10-Q refer to Petros Pharmaceuticals, Inc. and its subsidiaries.

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TABLE OF CONTENTS


		Page

PART I—FINANCIAL INFORMATION		4

Item 1. Financial Statements		4

Consolidated Balance Sheets as of June 30, 2022 (unaudited) and December 31, 2021		4

Consolidated Statements of Operations for the three and six months ended June 30, 2022 and 2021 (unaudited)		5

Consolidated Statements of Changes in Stockholders’ Equity for the three and six months ended June 30, 2022 and 2021 (unaudited)		6

Consolidated Statements of Cash Flows for the six months ended June 30, 2022 and 2021 (unaudited)		7

Notes to Consolidated Financial Statements		8

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.		26

Item 3. Quantitative and Qualitative Disclosures About Market Risk.		44

Item 4. Controls and Procedures.		44

PART II—OTHER INFORMATION		45

Item 1. Legal Proceedings.		45

Item 1A. Risk Factors.		45

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.		46

Item 3. Defaults Upon Senior Securities.		46

Item 4. Mine Safety Disclosures.		46

Item 5. Other Information.		46

Item 6. Exhibits.		47

Signatures.		48

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PART I—FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS.

PETROS PHARMACEUTICALS, INC.

CONSOLIDATED BALANCE SHEETS


	June 30,		December 31,
	2022		2021
	(Unaudited)		(Audited)
Assets
Current assets:
Cash	$	13,295,089	$	23,847,572
Accounts receivable, net		5,747,884		2,455,386
Inventories		1,908,857		519,649
Prepaid expenses and other current assets		1,901,407		3,720,088
Total current assets		22,853,237		30,542,695

Fixed assets, net		44,287		49,397
Intangible assets, net		22,176,519		25,293,149
API purchase commitment		5,557,119		11,029,260
Other assets		418,779		475,557
Total assets	$	51,049,941	$	67,390,058

Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	1,904,548	$	4,557,969
Accrued expenses		4,007,928		11,957,384
Accrued inventory purchases		—		14,203,905
Other current liabilities		559,530		260,818
Current portion of Promissory Note		904,842		—
Total current liabilities		7,376,848		30,980,076

Promissory Note		9,119,943		—
Derivative liability		—		460,000
Other long-term liabilities		336,109		405,018
Total liabilities		16,832,900		31,845,094

Stockholders’ Equity:
Preferred stock (par value $0.0001 per share, 50,000,000 shares authorized, 0 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively)		—		—
Common stock (par value $0.0001 per share, 150,000,000 shares authorized, 20,684,723 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively		2,068		2,068
Additional paid-in capital		106,889,809		106,231,716
Accumulated deficit		(72,674,836)		(70,688,820)
Total Stockholders’ Equity		34,217,041		35,544,964

Total Liabilities and Stockholders' Equity	$	51,049,941	$	67,390,058

The accompanying Notes are an integral part of the Consolidated Financial Statements.

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PETROS PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)


	For the Six Months Ended June 30,				For the Three Months Ended June 30,
	2022		2021		2022		2021
Net sales	$	6,651,685	$	6,533,255	$	4,186,516	$	2,457,649
Cost of goods sold		1,121,560		1,036,680		649,220		393,294
Gross profit		5,530,125		5,496,575		3,537,296		2,064,355
Operating expenses:
Selling, general and administrative		7,114,342		7,997,890		3,216,604		4,116,173
Gain on settlement with Vivus		(3,389,941)		—		—		—
Research and development expense		826,602		519,227		421,242		500,046
Depreciation and amortization expense		3,121,740		3,457,657		1,560,870		1,728,828
Total operating expenses		7,672,743		11,974,774		5,198,716		6,345,047

Loss from operations		(2,142,618)		(6,478,199)		(1,661,420)		(4,280,692)
Change in fair value of derivative liability		460,000		7,670,000		—		2,290,000
Interest expense, senior debt		—		(288,937)		—		(115,525)
Interest expense, promissory note		(303,398)		—		(150,372)		—
Income (loss) before income taxes		(1,986,016)		902,864		(1,811,792)		(2,106,217)
Income tax expense (benefit)		—		6,700		—		6,700
Net Income (loss)	$	(1,986,016)	$	896,164	$	(1,811,792)	$	(2,112,917)
Net Income (loss) per common share
Basic and Diluted	$	(0.10)	$	0.09	$	(0.09)	$	(0.22)
Weighted average common shares outstanding
Basic		20,684,723		9,777,834		20,684,723		9,802,309
Effects of common share equivalents		—		1,501		—		—
Diluted		20,684,723		9,779,335		20,684,723		9,802,309

The accompanying Notes are an integral part of the Consolidated Financial Statements.

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PETROS PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

(Unaudited)


			Preferred			Common		Additional
	Preferred		Stock		Common	Stock		Paid-in		Accumulated
	Stock		Amount		Stock	Amount		Capital		Deficit		Total
Three Months Ended June 30, 2022
Balance, March 31, 2022		—	$	—	20,684,723	$	2,068	$	106,587,544	$	(70,863,044)	$	35,726,568
Stock-based compensation expense		—		—	—		—		302,265		—		302,265
Net loss		—		—	—		—		—		(1,811,792)		(1,811,792)
Balance, June 30, 2022		—	$	—	20,684,723	$	2,068	$	106,889,809	$	(72,674,836)	$	34,217,041


			Preferred			Common		Additional
	Preferred		Stock		Common	Stock		Paid-in		Accumulated
	Stock		Amount		Stock	Amount		Capital		Deficit		Total
Six Months Ended June 30, 2022
Balance, December 31, 2021		—	$	—	20,684,723	$	2,068	$	106,231,716	$	(70,688,820)	$	35,544,964
Stock-based compensation expense		—		—	—		—		658,093		—		658,093
Net loss		—		—	—		—		—		(1,986,016)		(1,986,016)
Balance, June 30, 2022		—	$	—	20,684,723	$	2,068	$	106,889,809	$	(72,674,836)	$	34,217,041


			Preferred			Common		Additional
	Preferred		Stock		Common	Stock		Paid-in		Accumulated
	Stock		Amount		Stock	Amount		Capital		Deficit		Total
Three Months Ended June 30, 2021
Balance, March 31, 2021		—	$	—	9,798,261	$	980	$	79,615,223	$	(58,693,063)	$	20,923,140
Conversion of Preferred Stock to Common Stock		—		—	—		—		—		—		—
Non-employee stock-based compensation		—		—	28,338		3		89,999		—		90,002
Stock-based compensation		—		—	—		—		590,502		—		590,502
Net Income		—		—	—		—		—		(2,112,917)		(2,112,917)
Balance, June 30, 2021		—	$	—	9,826,599	$	983	$	80,295,724	$	(60,805,980)	$	19,490,727


			Preferred			Common		Additional
	Preferred		Stock		Common	Stock		Paid-in		Accumulated
	Stock		Amount		Stock	Amount		Capital		Deficit		Total
Six Months Ended June 30, 2021
Balance, December 31, 2020		500	$	—	9,707,655	$	971	$	79,170,225	$	(61,702,144)	$	17,469,052
Conversion of Preferred Stock to Common Stock		(500)		—	60,606		6		(6)		—		—
Non-employee stock-based compensation		—		—	58,338		6		187,796		—		187,802
Stock-based compensation		—		—	—		—		937,709		—		937,709
Net Income		—		—	—		—		—		896,164		896,164
Balance, June 30, 2021		—	$	—	9,826,599	$	983	$	80,295,724	$	(60,805,980)	$	19,490,727

The accompanying Notes are an integral part of the Consolidated Financial Statements.

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PETROS PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)


	For the Six Months Ended June 30,
	2022		2021
Cash flows from operating activities:
Net income (loss)	$	(1,986,016)	$	896,164
Adjustments to reconcile net income (loss) to net cash used in operating activities:
Depreciation and amortization		3,121,740		3,457,657
Bad debt expense (recoveries)		(106,940)		17,742
Inventory and sample inventory reserve		(14,858)		(360,514)
Amortization of deferred financing costs and debt discount		—		12,500
Lease expense		56,778		50,479
Derivative liability		(460,000)		(7,670,000)
Deferred revenue		121,146		89,805
Gain on settlement with Vivus		(3,389,941)		—
Employee stock-based compensation		658,093		937,709
Non-employee stock-based compensation		—		187,802
Changes in operating assets and liabilities:
Accounts receivable		(3,185,558)		3,114,312
Inventories		(1,374,350)		710,496
Prepaid expenses and other current assets		1,058,333		85,081
Accounts payable		(2,653,421)		(3,011,666)
Accrued expenses		(1,429,156)		(918,929)
Other current liabilities		177,550		186,343
Other long-term liabilities		(68,909)		(131,347)
Net cash used in operating activities		(9,475,509)		(2,346,366)

Cash flows from financing activities:
Payment of promissory note		(1,076,974)		—
Payment of senior debt		—		(3,227,914)
Payment of portion of senior dent end of term fee		—		(534,237)
Net cash used in financing activities		(1,076,974)		(3,762,151)

Net decrease in cash		(10,552,483)		(6,108,517)

Cash, beginning of period		23,847,572		17,139,694
Cash, end of period	$	13,295,089	$	11,031,177

Supplemental cash flow information:
Cash paid for interest during the period	$	153,026	$	309,497

Noncash Items:
Noncash decrease in accrued expenses related to Vivus settlement	$	(6,520,283)	$	—
Noncash decrease in accrued inventory purchases related to Vivus Settlement		(14,203,905)		—
Noncash increase in promissory note related to Vivus settlement		10,024,785		—
Noncash decrease in API purchase commitment		6,232,489		—

The accompanying Notes are an integral part of the Consolidated Financial Statements.

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PETROS PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

1) Nature of Operations, Basis of Presentation, and Liquidity

Nature of Operations

Petros Pharmaceuticals, Inc. (“Petros” or the “Company”) is a pharmaceutical company focused on men’s health therapeutics with a full range of commercial capabilities including sales, marketing, regulatory and medical affairs, finance, trade relations, pharmacovigilance, market access relations, manufacturing, and distribution.

Petros consists of wholly owned subsidiaries, Metuchen Pharmaceuticals LLC, a Delaware limited liability company (“Metuchen”), Neurotrope, Inc., a Nevada corporation (“Neurotrope”), Timm Medical Technologies, Inc. (“Timm Medical”), and Pos-T-Vac, LLC (“PTV”). 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 we 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. In addition to ED products, we have acquired an exclusive global license to develop and commercialize H100™, a novel and patented topical formulation candidate for the treatment of acute Peyronie’s disease.

The Company was organized as a Delaware corporation 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 (the “Merger Agreement”), by and between Petros, Neurotrope,, PM Merger Sub 1, LLC, a Delaware limited liability company and a wholly-owned subsidiary of Petros (“Merger Sub 1”), PN Merger Sub 2, Inc., a Delaware corporation and a wholly-owned subsidiary of Petros (“Merger Sub 2”), and Metuchen. 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 into Neurotrope, with Neurotrope 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 and Neurotrope became wholly-owned subsidiaries of Petros, and Petros became a publicly traded corporation on December 1, 2020. On December 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 of Neurotrope not retained by Neurotrope in connection with the Mergers were contributed to Synaptogenix, Inc. (formerly known as Neurotrope Bioscience, Inc.), a Delaware corporation (“Synaptogenix”), and a wholly-owned subsidiary of Neurotrope.

Basis of Presentation

The accompanying unaudited interim consolidated financial statements have been prepared in accordance with U.S. GAAP. In the opinion of management, the accompanying unaudited interim consolidated financial statements include all adjustments, consisting of normal recurring adjustments, considered necessary to present fairly our financial position, results of operations and cash flows. However, actual results could differ from those estimates. The unaudited interim consolidated results of operations are not necessarily indicative of the results that may occur for the full fiscal year. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been omitted pursuant to instructions, rules, and regulations prescribed by the United States Securities and Exchange Commission. This Quarterly Report on Form 10-Q should be read in conjunction with the audited financial statements and notes previously distributed in our Annual Report on Form 10-K for the year ended December 31, 2021.

All transactions between the consolidated entities have been eliminated in consolidation.

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Liquidity

The Company has experienced net losses and negative cash flows from operations since our inception. As of June 30, 2022, the Company had cash of $13 million, positive working capital of $15 million, an accumulated deficit of $73 million and used cash in operations during the six months ended June 30, 2022 of $9 million. The Company’s plans include, or may include, utilizing its 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 in the principal amount of $10,201,758. The terms of this promissory note are discussed in Note 8. The Company believes the cash on hand is sufficient to fund operations and debt service through at least August 15, 2023, however for periods after August 15, 2023, the Company may need to raise additional funds or curtail certain discretionary expenditures in order to maintain an appropriate level of cash to fund our operations. While the Company is optimistic that it will be successful in its efforts to achieve its plans, there can be no assurances that it will be successful in doing so.

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.

The World Health Organization (“WHO”) declared the coronavirus (“COVID-19”) a global pandemic on March 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. Accordingly, the COVID-19 pandemic may continue to have negative effects on the health of the U.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 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 2022 and beyond.

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. In March 2020, the Company reduced our 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, in March 2020, the Company closed its administrative offices. In January 2022, the Company sub-leased its Manalapan office and all administrative employees are working remotely for the foreseeable future. The Company has fully 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. Since the beginning of the COVID-19 pandemic, we have experienced a shift from in-person sales to online, telehealth-based sales. These online sales generally have lower gross margins than in-person sales, which has impacted our net revenues.

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Revenue Recognition

Prescription Medication Sales

The Company’s prescription medication sales consist of sales of Stendra® in the U.S. for the treatment of male erectile dysfunction. Under Accounting Standards Codification (“ASC”) Topic 606, Revenue Recognition (“Topic 606”), the Company recognizes revenue from prescription medication sales when its performance obligations with a customer has been satisfied. In the contracts with its customers, the Company has identified a single performance obligation to provide Stendra® upon receipt of a customer order. The performance obligation is satisfied at a point in time when the Company’s customers obtain control of Stendra®, which is typically upon delivery. The Company invoices its customers after Stendra® has been delivered and invoice payments are generally due within 30 to 75 days of invoice date.

In determining the transaction price, a significant financing component does not exist since the timing from when the Company delivers Stendra® to when the customers pay for the product is typically less than one year. The Company records prescription medication sales net of any variable consideration, including but not limited to discounts, rebates, returns, chargebacks, and distribution fees. The Company uses the expected value method when estimating its variable consideration, unless terms are specified within contracts. The identified variable consideration is recorded as a reduction of revenue at the time revenues from sales of Stendra® are recognized. The Company recognizes revenue to the extent that it is probable that a significant revenue reversal will not occur in a future period. These estimates may differ from actual consideration received. The Company evaluates these estimates each reporting period to reflect known changes.

As of June 30, 2022 and December 31, 2021, the reserves for sales deductions were $4.1 million and $4.7 million, respectively. The most significant sales deductions included in this reserve relate to returns, contract rebates, and distribution service (“DSA”) fees. Our estimates are based on factors such as our direct and indirect customers’ buying patterns and the estimated resulting contractual deduction rates, historical experience, specific known market events and estimated future trends, current contractual and statutory requirements, industry data, estimated customer inventory levels, current contract sales terms with our direct and indirect customers, and other competitive factors. Significant judgment and estimation is required in developing the foregoing and other relevant assumptions. The most significant sales deductions are further described below.

Product Returns

Consistent with industry practice, the Company maintains a return policy that generally allows its customers to return Stendra® and receive credit for product within six months prior to expiration date and up to one year 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, 2022 and December 31, 2021, the reserves for product returns were $3.0 million and $3.8 million, respectively, and are included as a component of accrued expenses.

Contract Rebates, Coupon Redemptions and DSA Fees

The Company establishes contracts with wholesalers, chain stores, and indirect customers that provide for rebates, sales incentives, DSA fees and other allowances. Some customers receive rebates upon attaining established sales volumes. Direct rebates are generally rebates paid to direct purchasing customers based on a percentage applied to a direct customer’s purchases from us, including fees paid to wholesalers under our DSAs, as described below. Indirect rebates are rebates paid to indirect customers that have purchased our products from a wholesaler under a contract with us.

The Company has entered into DSAs with certain of our significant wholesaler customers that obligate the wholesalers, in exchange for fees paid by us, to: (i) manage the variability of their purchases and inventory levels within specified limits based on product demand and (ii) provide us with specific services, including the provision of periodic retail demand information and current inventory levels for our pharmaceutical products held at their warehouse locations. See Note 3 Accounts Receivable, net for further discussion of these reserves.

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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 does not exist since the timing from when the Company delivers the medical devices to when the customers pay for the product is typically less than one year. The Company records medical device sales net of any variable consideration, including but not limited to returns. The Company uses the expected value method when estimating its variable consideration. The identified variable consideration is recorded as a reduction of revenue at the time revenues from the medical device 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.

Product Returns

Consistent with industry practice, the Company maintains a return policy that generally allows its customers to return medical devices and receive credit for products within 90 days of the sale. The provision for returns is based upon the Company’s estimates for future product returns and historical experience. As of June 30, 2022 and December 31, 2021, 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, 2022 and December 31, 2021.

Fair Value of Financial Instruments

Certain assets and liabilities are carried at fair value under U.S. 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, and other current liabilities approximate their fair values due to the short-term nature of these instruments.

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In connection with the Mergers in December 2020, each security holder of Metuchen received an earnout consideration classified as a derivative liability 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. The fair value of the derivative liability as of June 30, 2022 and December 31, 2021 was $0 million and $0.5 million, respectively. See Note 9 Stockholders’ Equity.

Stock-Based Compensation

The Company accounts for stock-based awards to employees and consultants in accordance with applicable accounting principles, which requires compensation expense related to stock-based transactions, including employee stock options and consultant warrants, to be measured and recognized in the financial statements based on a determination of the fair value of the stock options or warrants. The grant date fair value is determined using the Black-Scholes-Merton (“Black-Scholes”) pricing model. Employee stock option and consulting expenses are recognized over the employee’s or consultant’s requisite service period (generally the vesting period of the equity grant).

The Company’s option pricing model requires the input of highly subjective assumptions, including the volatility and expected term. Any changes in these highly subjective assumptions can significantly impact stock-based compensation expense. See Note 10 Stock Options.

Income Taxes

The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements. Under this method, the Company determines deferred tax assets and liabilities on the basis of the differences between the financial statement and tax bases of assets and liabilities by using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date.

The Company recognizes deferred tax assets to the extent that it believes that these assets are more likely than not to be realized. In making such a determination, the Company considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If the Company determines that it would be able to realize deferred tax assets in the future in excess of its net recorded amount, the Company would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes.

The Company records uncertain tax positions in accordance with ASC 740 on the basis of a two-step process in which (1) it determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions that meet the more-likely-than-not recognition threshold, the Company recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority.

The Company recognizes interest and penalties related to unrecognized tax benefits on the income tax expense line in the accompanying consolidated statement of operations. As of June 30, 2022 and December 31, 2021, 0 accrued interest or penalties are recorded in the consolidated balance sheet.

Basic and Diluted Net Loss per Common Share

The Company computes basic net loss per common share by dividing net loss applicable to common stockholders by the weighted average number of shares of common stocks outstanding during the period, excluding the anti-dilutive effects of stock options and warrants to purchase common stocks. The Company computes diluted net loss per common stock by dividing the net loss applicable to common stocks by the sum of the weighted-average number of common stocks outstanding during the period plus the potential dilutive effects of its convertible preferred stocks, stock options and warrants to purchase common stocks, but such items are excluded if their effect is anti-dilutive. Because the impact of these items is anti-dilutive during periods of net loss, there was no difference between the Company’s basic and diluted net loss per stock of common stock for the three and six months ended June 30, 2022. See Note 13 Basic and Diluted Net Loss per Common Share.

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Recent Accounting Pronouncements

Pending Adoption as of June 30, 2022

In June 2016, the Financial Accounting Standard Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-13, Measurement of Credit Losses on Financial Instruments. ASU 2016-13, together with a series of subsequently issued related ASUs, has been codified in Topic 326. Topic 326 establishes new requirements for companies to estimate expected credit losses when measuring certain financial assets, including accounts receivables. The new guidance is effective for fiscal years beginning after December 15, 2022. The Company is currently evaluating the effect that the new guidance will have on its consolidated financial statements and related disclosures.

3) Accounts Receivable, net

Accounts receivable, net is comprised of the following:


	June 30,		December 31,
	2022		2021
Gross accounts receivables	$	6,856,969	$	3,363,827
Distribution service fees		(661,872)		(371,310)
Chargebacks accrual		(1,960)		—
Cash discount allowances		(174,508)		(159,446)
Allowance for doubtful accounts		(270,745)		(377,685)
Total accounts receivable, net	$	5,747,884	$	2,455,386

For the six months ended June 30, 2022, gross sales from customers representing 10% or more of the Company’s total gross sales included 4 customers which represented approximately 26%, 23%, 18% and 17% of total gross sales, respectively. For the six months ended June 30, 2021, gross sales from customers representing 10% or more of the Company’s total gross sales included 2 customer which represented approximately 49% and 14% of total gross sales.

Receivables from customers representing 10% or more of the Company’s gross accounts receivable included 3 customers at June 30, 2022 equal to 35%, 27%, and 24%, respectively, of the Company’s total gross accounts receivables. Receivables from customers representing 10% or more of the Company’s gross accounts receivable included 3 customers at December 31, 2021 equal to 40%, 19% and 15%, respectively, of the Company’s total gross accounts receivables.

4) Inventories

Inventory is comprised of the following:


	June 30, 2022		December 31, 2021
Raw materials	$	1,206,570	$	359,741
Finished goods		702,287		159,908
Total inventory	$	1,908,857	$	519,649

Finished goods are net of valuation reserves of $368,440 and $383,298 as of June 30, 2022 and December 31, 2021, respectively. Raw materials are net of valuation reserves of $2,872,977 as of June 30, 2022 and December 31, 2021, which is related to bulk inventory.

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5) Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets are comprised of the following:


	June 30, 2022		December 31, 2021
Prepaid insurance	$	150,233	$	73,223
Prepaid FDA fees		277,060		831,179
Prepaid coupon fees		71,500		71,500
API purchase commitment asset (see Note 13)		659,190		1,419,538
Due from wholesalers		104,059		609,059
Other prepaid expenses		509,631		605,422
Other current assets		129,734		110,167
Total prepaid expenses and other current assets	$	1,901,407	$	3,720,088

6) Intangible Assets


Balance at December 31, 2020	$	32,160,919
Amortization expense		(6,867,770)
Balance at December 31, 2021		25,293,149
Amortization expense		(3,116,630)
Balance at June 30, 2022	$	22,176,519

The future annual amortization related to the Company’s intangible assets is as follows as of June 30, 2022:


2022 (remaining 6 months)		3,075,111
2023		5,445,729
2024		4,650,787
2025		2,716,011
2026		2,201,720
Thereafter		4,087,161
Total	$	22,176,519

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, 2022 are $16.5 million, $4.4 million and $1.2 million, respectively. The carrying value of the Stendra® product, Timm Medical product, and PTV product as of December 31, 2021 were $19.1 million, $4.9 million and $1.4 million, respectively. The Company determined that no impairment existed as of June 30, 2022.

7) Accrued Expenses

Accrued expenses are comprised of the following:


	June 30, 2022		December 31, 2021
Accrued price protection (see note 13)	$	—	$	1,853,979
Accrued product returns		2,960,390		6,192,845
Accrued contract rebates		262,513		379,242
Due to Vivus (see Note 13)		—		2,267,523
Due to third-party logistics provider		120,516		479,178
Accrued bonuses		355,198		527,563
Accrued professional fees		1,000		125,392
Other accrued expenses		308,311		131,662
Total accrued expenses	$	4,007,928	$	11,957,384

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8) Debt

Promissory Note

In connection with the Settlement Agreement entered into with Vivus (see Note 13), Petros executed an interest-bearing promissory note (the “Note”) in favor of Vivus in the principal amount of $10,201,758. The parties also entered into a Security Agreement to secure Petros’ obligations under the Note.

Under the terms of the Note, the original principal amount of $10,201,758 is payable in consecutive quarterly installments of principal and interest beginning on April 1, 2022 through January 1, 2027. Interest on the principal amount will accrue at a rate of 6% per year. The Company may prepay the Note, in whole or in part, at any time, with no premium or penalty. In the event that the Company defaults under the Security Agreement, all principal outstanding under the Note at the time of the default will bear interest at a rate of 9% per year until the full and final payment of all principal and interest under the Note (regardless of whether any default is waived or cured). Pursuant to the Security Agreement, dated January 18, 2022, the Company granted to Vivus a continuing security interest in all of its Stendra® API and products and its rights under the License Agreement.

Future minimum principal payments of the promissory note are as follows:


2022 (remaining 6 months)	$	361,951
2023		1,274,741
2024		1,530,729
2025		2,720,940
2026		3,264,351
2027		872,074
	$	10,024,785

Senior Debt

The Company did not have any senior indebtedness as of June 30, 2022 and December 31, 2021.

On September 30, 2016, the Company entered into a loan agreement with Hercules, a third party, for a $35 million term loan (“Senior Debt”) with a stated interest rate of the greater of either (i) Prime plus 7.25% or (ii) 10.75%. The Senior Debt included an additional Paid-In-Kind (“PIK”) interest that increased the outstanding principal on a monthly basis at an annual rate of 1.35% and a $787,500 end of term charge.

On November 22, 2017, the Company amended its loan agreement with Hercules (“First Amendment”). 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 (1:1 to 0.9:1) were reduced. The Company was also required to prepay $10,000,000 in principal.

Monthly principal payments, including interest, commenced November 1, 2018 with the outstanding balance of the Senior Debt due in full on November 1, 2020. The end of term charge was being recognized as interest expense and accreted over the term of the Senior Debt using the effective interest method.

On April 13, 2020, the Company amended its loan agreement with Hercules. The amendment waived all financial covenant defaults for all periods since inception through the period ending March 31, 2020. The amendment also included the following changes:

●

Removed the Adjusted EBITDA and Fixed Cost Coverage Ratio Covenants.

●

Extended the maturity date from October 1, 2020 to April 2021, which was further extendable to December 1, 2021 upon achieving the Financing Milestone, as defined in the agreement.

●

Increased the cash interest rate from the greater of (a) 10.75% or (b) 10.75% plus the US WSJ Prime minus 4.50% to the greater of (a) 11.50% or (b) 11.50% plus the US WSJ Prime minus 4.25%.

●

Removed the PIK interest rate.

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●

Removed the prepayment penalty.

The end of term charge of $1,068,750 was partially extended with $534,375 paid on October 1, 2020 and $534,375 paid on February 1, 2021.

Effective September 30, 2020, the Company and Hercules entered into the Third Amendment to Loan and Security Agreement (“Third Amendment”) to provide for interest only payments commencing on October 1, 2020 and continuing through December 22, 2020 unless the Company raised net cash proceeds of at least $25 million through an equity or debt financing or other transaction on or before December 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., Hercules and Wells Fargo Bank, N.A. entered into an escrow agreement (the “Escrow Agreement”) to escrow funds amounting to approximately $1.5 million, an amount equal to the aggregate of certain principal payments due under the Loan Agreement, as amended. In connection with the consummation of the Mergers, the funds held in escrow were disbursed back to Juggernaut 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 December 2020. As a result, the Senior Debt had a maturity date of December 1, 2021.

On November 3, 2021, the Company repaid $1,179,651 towards the senior debt. This payment satisfied the remaining balance of the senior debt as of that date.

Interest expense on the Senior Debt was $288,937 and $115,525 for the six and three months ended June 30, 2021, respectively. As of December 31, 2021, there was $0 of accrued and unpaid interest.

9) Stockholders’ Equity

On January 26, 2021, 500 shares of the Company’s Preferred Stock were converted into 60,606 shares of the Company’s common stock.

Effective January 1, 2021, the Company entered into a Marketing and Consulting Agreement (the “CoreIRAgreement”) with CorProminence, LLC (the “Consultant”) for certain shareholder information and relation services. The term of the CoreIRAgreement is for one year with automatic consecutive one-year renewal terms. As consideration for the shareholder information and relation services, the Company will pay the Consultant a monthly retainer of $7,500 and issued 30,000 restricted shares of the Company’s common stock to the Consultant on March 24, 2021 (the “CoreIR Grant Date”). The restricted shares vested immediately on the CoreIR Grant Date.

Effective April 1, 2021, the Company entered into a Consulting and Advisory Agreement (the “King Agreement”) with Tania King, an employee of Juggernaut Capital Partners LLP, a related party, for certain services. The term of the King Agreement is indefinite but may be terminated by either party, with or without cause. As consideration for the consulting and advisory services, the Company will pay Ms. King a monthly fee of $4,000, an additional $12,000 payment included with the first monthly fee for services provided since January 1, 2021, and issue restricted stock units for shares of the Company’s common stock (“RSU’s”) with a cash value of $72,000 as of the date of the grant (the “King Grant Date”). The RSU’s shall vest and settle in full on the one-year anniversary of the King Grant Date. On April 7, 2022, the Company issued an additional grant of 60,505 RSU’s of the Company’s common stock with a value of $72,001 as of the date of the grant. The RSU’s vest and settle in full on the one-year anniversary of the additional grant date.

Effective June 4, 2021, the Company entered into a Service Agreement with IRTH Communications, LLC (“IRTH”) for certain investor relations services (the “IRTH Agreement”). The term of the IRTH Agreement is for one year with an optional one-year renewal term. As consideration for the services, the Company will pay IRTH a fixed fee of $6,750 per month for the term of the IRTH Agreement and issued 28,338 restricted shares of the Company’s common stock with a value of $90,002 as of the date of the grant (the “IRTH Grant Date”). The restricted shares vest immediately on the IRTH Agreement Grant Date. The company has elected not to renew the IRTH Agreement as of June 2022.

Contingent Consideration

Pursuant to the Merger Agreement, each security holder of Metuchen received a right to receive such security holder’s pro rata stock of an aggregate of 14,232,090 shares of Petros Common Stock potentially issuable upon the achievement of certain milestones set forth in the Merger Agreement. The milestones are for the achievement of stock price and market capitalization, as defined over a two-year period.

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Market Capitalization/Gross Proceeds Earnout Payments

In connection with the Mergers, each security holder of Metuchen received the right to receive earnout consideration, which was liability classified, 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 that equals or exceeds certain milestones set forth in the Merger Agreement, as discussed below. Each milestone earnout payment was only achievable and payable one time and upon attainment of such milestone. In no event will the sum of the milestone earnout payments be greater than 10,232,090 shares of Petros Common Stock. As of June 30, 2022, the milestones have not been achieved. The fair value of the derivative liability was $0 and $0.5 million as of June 30, 2022 and December 31, 2021, respectively.

Metuchen equity holders will have the opportunity to receive the following during the period ending December 2022:

The Earnout Payment shall be equal to 2,000,000 shares of Petros Common Stock if:

Petros’ Market Capitalization (as defined in the Merger Agreement) is greater than or equal to $250,000,000 for a period of 20 (20) trading days during any 30 (30) consecutive trading day period with a Closing Price of no less than $17.50 on each such trading day; or

ii.

Petros receives aggregate gross proceeds of at least $25,000,000 in an offering (or series of offerings within a sixty (60) calendar day period) of Petros Common Stock with a price per share of Petros Common Stock sold equal to no less than $17.50 in each offering (or series of offerings) and where Petros has a Market Capitalization immediately prior to each such offering (or series of offerings) equal to at least $250,000,000.

The Earnout Payment shall be equal to 2,000,000 shares of Petros Common Stock if:

Petros’ Market Capitalization is greater than or equal to $300,000,000 for a period of 20 (20) trading days during any 30 (30) consecutive trading day period with a Closing Price of no less than $18.75 on each such trading day; or

ii.

Petros receives aggregate gross proceeds of at least $30,000,000 in an offering (or series of offerings within a sixty (60) calendar day period) of Petros Common Stock with a price per share of Petros Common Stock sold equal to no less than $18.75 in each offering (or series of offerings) and where Petros has a Market Capitalization immediately prior to each such offering (or series of offerings) equal to at least $300,000,000.

The Earnout Payment shall be equal to 3,000,000 shares of Petros Common Stock if:

Petros’ Market Capitalization is greater than or equal to $400,000,000 for a period of 20 (20) trading days during any 30 (30) consecutive trading day period with a Closing Price of no less than $22.50 on each such trading day; or

ii.

Petros receives aggregate gross proceeds of at least $40,000,000 in an offering (or series of offerings within a sixty (60) calendar day period) of Petros Common Stock with a price per share of Petros Common Stock sold equal to no less than $22.50 in each offering (or series of offerings) and where Petros has a Market Capitalization immediately prior to each such offering (or series of offerings) equal to at least $400,000,000.

The Earnout Payment shall be equal to 3,232,090 shares of Petros Common Stock if:

Petros’ Market Capitalization is greater than or equal to $500,000,000 for a period of 20 (20) trading days during any 30 (30) consecutive trading day period with a Closing Price of no less than $23.75 on each such trading day; or

Petros receives aggregate gross proceeds of at least $50,000,000 in an offering (or series of offerings within a sixty (60) calendar day period) of Petros Common Stock with a price per share of Petros Common Stock sold equal to no less than $23.75 in each offering (or series of offerings) and where Petros has a Market Capitalization immediately prior to each such offering (or series of offerings) equal to at least $500,000,000.

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10) Stock Options and Restricted Stock Units (“RSU’s”)

The Company established the 2020 Omnibus Incentive Compensation plan (the “2020 Plan”) which provides for the grants of awards to our directors, officers, employees, and consultants. The 2020 Plan authorizes the grant of incentive stock options, nonqualified stock options, stock appreciation rights, stock awards, stock units and other stock-based awards and cash-based awards. On December 22, 2021, our stockholders approved the Second Amendment to the 2020 Plan to increase the total number of shares of common stock issuable under the 2020 Plan by 1,521,654 shares to a total of 2,600,000 shares of common stock. As of June 30, 2022, there were 2,600,000 shares authorized and 1,583,701 shares available for issuance under the 2020 Plan.

The following is a summary of stock options for the six months ended June 30, 2022 and for the year ended December 31, 2021:


				Weighted-Average
		Weighted-		Remaining	Aggregate Intrinsic
	Number of	Average		Contractual	Value
	Shares	Exercise Price		Term (Years)	($ in thousands)
Options outstanding at December 31, 2020	574,331	$	51.43	0.9	$	—
Options granted	615,669		3.38	9.23		—
Less: options forfeited	—		—	—		—
Less: options expired/cancelled	(574,331)		51.43	—		—
Less: options exercised	—		—	—		—
Options outstanding at December 31, 2021	615,669		3.38	9.23		—
Options granted	50,000		3.34	9.52		—
Less: options forfeited	(75,000)		(3.21)	—		—
Less: options expired/cancelled	—		—	—		—
Less: options exercised	—		—	—		—
Options outstanding at June 30, 2022	590,669	$	3.40	8.80	$	—

Options exercisable at June 30, 2022	444,252	$	3.40	8.82	$	—

The following is a summary of RSU’s for the six months ended June 30, 2022 and for the year ended December 31, 2021:


				Weighted-Average
		Weighted-		Remaining	Aggregate Intrinsic
	Number of	Average		Contractual	Value
	Shares	Exercise Price		Term (Years)	($ in thousands)
RSU’s outstanding at December 31, 2020	0	$	0	—	$	—
RSU’s granted	116,383		3.29	9.84		—
Less: RSU’s forfeited	—		—	—		—
Less: RSU’s expired/cancelled	—		—	—		—
Less: RSU’s exercised	—		—	—		—
RSU’s outstanding at December 31, 2021	116,383		3.29	9.84		—
RSU’s granted	309,247		1.19	9.77		—
Less: RSU’s forfeited	—		—	—		—
Less: RSU’s expired/cancelled	—		—	—		—
Less: RSU’s exercised	—		—	—		—
RSU’s outstanding at June 30, 2022	425,630	$	1.76	9.65	$	—
RSU’s exercisable at June 30, 2022	72,000	$	3.09	—	$	—

On January 4, 2022, pursuant to a consulting agreement, the Company awarded a grant of 50,000 options to purchase shares of common stock of the Company at an exercise price of $3.34 per share. The shares of common stock underlying the options vested 100% upon issuance.

On April 7, 2022, the Company awarded the 4 Directors grants of 248,742 total RSU’s with a stock price of $1.19 per share. The RSU’s shall vest 100% on the one year anniversary of the date of grant. Also on April 7, 2022, Tania King, an employee of Juggernaut Capital Partners LLP, pursuant to her contract, was granted 60,505 RSUs with a stock price of $1.19 per share. The RSU’s shall vest 100% on the one year anniversary of the date of grant.

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Stock-based compensation expense recognized for the six months ended June 30, 2022 and 2021 was $658,093 and $937,709, respectively and, for the three months ended June 30, 2022 and 2021 was $302,265 and $590,502, respectively, and is recorded in general and administrative expenses in the consolidated statements of operations.

11) Common Stock Warrants

The following is a summary of warrants for the six months ended June 30, 2022 and for the year ended December 31, 2021:


		Number of Shares
Warrants outstanding at December 31, 2020		4,407,962
Warrants issued		7,853,558
Warrants exercised		(2,014,586)
Warrants expired		(207,913)
Warrants outstanding at December 31, 2021 and June 30, 2022		10,039,021

As of June 30, 2022, the Company’s warrants by expiration date were as follows:


Number of Warrants	Exercise Price		Expiration Date
2,780	$	1.60	August 23, 2023
22,800		35.65	June 1, 2024
74,864		21.85	June 17, 2024
20,043		31.25	June 19, 2024
22,800		26.55	September 1, 2024
10,500		12.738	September 16, 2024
22,800		4.30	December 1, 2024
28,000		5.65	March 2, 2025
28,000		7.30	June 1, 2025
28,000		5.50	September 1, 2025
28,000		4.705	December 1, 2025
2,221,829		7.50	December 1, 2025
908,498		17.50	December 1, 2025
623,303		51.25	December 1, 2025
157,832		125.00	December 1, 2025
1,751,311		1.715	October 19, 2026
2,337,719		3.50	December 2, 2026
1,749,942		3.50	December 27, 2026
10,039,021

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12) Basic and Diluted Net Income (Loss) per Common Share

The following is a reconciliation of the weighted average number of common shares outstanding used in calculating basic and diluted net loss per share:


	For the Three Months Ended				For the Six Months Ended
	June 30,				June 30,
	2022		2021		2022		2021
Numerator
Net income (loss)	$	(1,811,792)	$	(2,112,917)	$	(1,986,016)	$	896,164
Denominator
Weighted-average common shares for basic net income (loss) per share		20,684,723		9,802,309		20,684,723		9,777,834
Effect of common share equivalents within common stock warrants		—		—		—		1,501
Weighted-average common shares for dilutive net income (loss) per share		20,684,723		9,802,309		20,684,723		9,779,335

Basic and diluted net income (loss) per common share	$	(0.09)	$	(0.22)	$	(0.10)	$	0.09

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,
	2022	2021	2022	2021
Stock Options	590,669	1,213,301	590,669	1,213,301
Warrants	10,039,021	4,407,962	10,039,021	4,405,182
Total	10,629,690	5,621,263	10,629,690	5,618,483

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.

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In connection with the License Agreement, the Company and Vivus also entered into a Supply Agreement. The Supply Agreement, was terminated, effective September 30, 2021.

On January 18, 2022, Petros and Vivus entered into a Settlement Agreement (the “Vivus Settlement Agreement”) related to the minimum purchase requirements under the Vivus Supply Agreement in 2018, 2019 and 2020 and certain reimbursement rights asserted by a third-party retailer in connection with quantities of the Company’s Stendra® product that were delivered to the third-party retailer and later returned. In connection with the Vivus Settlement Agreement, Petros retained approximately $7.3 million of 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 payment and upon the Company’s satisfaction of certain regulatory submissions, Vivus released 50% of the quantity of bulk Stendra® tablets on January 18, 2022 under the Company’s existing open purchase order (the “Open Purchase Order”) being held by Vivus, which represents approximately a six-month supply of inventory. Pursuant to the Vivus Settlement Agreement, Vivus also released the remaining 50% of the quantity of bulk Stendra® tablets under the Open Purchase Order, later during the first quarter of 2022, upon the Company’s satisfaction of the remaining regulatory submission requirements..

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 six months ended June 30, 2022.

As of June 30, 2022 and December 31, 2021, the Company has $0 and $14.2 million, respectively, of accrued inventory purchases related to the Company’s minimum purchase obligations with Vivus for raw material or API inventory.

API inventory is not a finished good as the Company does not have title to the product and therefore classifies 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, 2022 and December 31, 2021, there was $0.7 million included in other current assets (see Note 5 Prepaid and Other Current Assets). As of June 30, 2022 and December 31, 2021, there was $5.5 million and $11.0 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, 2022 and 2021.

During the six months ended June 30, 2022 and 2021, the Company incurred royalties to MTPC for Stendra® of $242,847 and $233,481, respectively. Royalties incurred were included in cost of goods sold in the consolidated statements of operations. As of June 30, 2022 and December 31, 2021, the Company had a payable for royalties of $161,711 and a receivable for royalties of $81,136, which are included in other current liabilities and other current assets, respectively (see Note 7 Accrued Expenses and Note 5 Prepaid and other Current Assets).

The license agreement between MTPC and Vivus (“MTPC License”) contains certain termination rights that would allow MTPC to terminate the agreement if Vivus were to breach any of the terms of the MTPC License or become insolvent or bankrupt. In the event that MTPC terminates the MTPC License with Vivus because of any contractual breach the Company has step-in rights with MTPC, which would allow the Company to continue to sell Stendra®.

(b) Patheon

Following the termination of the Vivus Supply Agreement, Petros, through its subsidiary Metuchen, entered into a Technology Transfer Service Agreement on January 20, 2022 with Patheon Pharmaceuticals Inc., part of Thermo Fisher Scientific (“Patheon”), pursuant to which the Company and Patheon agreed to collaborate as strategic partners for commercial production of Stendra® tablets at Patheon’s facilities in Cincinnati, Ohio. Under the Agreement, Patheon or one of its affiliates will provide pharmaceutical development and

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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.

In March 2020, the Company acquired the exclusive license to H100™ from Hybrid. H100™ is a topical candidate with at least one active ingredient and potentially a combination of ingredients responsible for the improvement of penile curvature during the acute phase of Peyronie’s disease. The Company paid an initial license fee of $100,000, with an additional $900,000 payment due upon obtainment of orphan indication for H100™ and termination of Hybrid’s existing agreement with a compounding pharmacy, and additional annual payments of $125,000, $150,000 and $200,000 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. In addition, the Company may terminate at any time after its first anniversary, without cause, upon ninety (90) days’ notice.

The Company has treated the acquisition as an asset acquisition and has concluded that the asset acquired and the upfront payment should be expensed as it was considered an IPR&D asset with no alternative future uses.

On September 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 to March 24, 2021. In consideration for the extension, the Company paid Hybrid $50,000 in October 2020 and an additional $100,000 in December 2020. On March 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 to September 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. On September 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 on October 1, 2021, $200,000 on October 31, 2021, $200,000 on December 1, 2021, $200,000 on December 23, 2021 and $150,000 on March 24, 2022.

14) Commitments and Contingencies

(a) Employment Agreements

The Company has employment agreements with certain executive officers and key employees that provide for, among other things, salary and performance bonuses.

In connection with the consummation of the Mergers, on December 24, 2020, the Company and Mr. Keith Lavan entered into a Separation Agreement (the “Separation Agreement”), pursuant to which Mr. Lavan resigned as Senior Vice President and Chief Financial Officer of the Company and agreed to serve as an advisor to the Company through December 31, 2020 (the “Separation Date”). Pursuant to the Separation Agreement, in addition to other benefits, Mr. Lavan received a stay-on bonus of $50,000 for continuing to remain employed by the Company through the Separation Date. For his services as an advisor, the Company agreed to pay Mr. Lavan an amount equal to 50% of his base salary as of immediately prior to the Separation Date. The Company paid 70% of such amount on January 15, 2021 and 30% of such amount in equal installments from the Separation Date through June 30, 2021. In addition, Mr. Lavan executed a general release of liabilities in favor of the Company.

(b) Legal Proceedings

On July 14, 2020, Greg Ford, the Chief Executive Officer of the Company, was terminated. On July 14, 2020, Mr. Ford, through his attorney, claimed that he was entitled to severance pay pursuant to an employment agreement following the termination of his employment on that same date. This claim is currently at an early stage where the Company is unable to determine the likelihood of any unfavorable outcome.

The Company is not currently involved in any other significant claims or legal actions that, in the opinion of management, will have a material adverse impact on the Company’s operations, financial position or cash flows.

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The Company has commitments under operating leases for office and warehouse space used in its operations. The Company’s leases have remaining lease terms ranging from 2.2 years to 4.5 years.

On November 30, 2021, the Company entered into a sublease with respect to its entire headquarters facility. The sublessor delivered a $14,000 security deposit to the Company on the lease commencement date and also agreed to pay $7,000 per month for the term beginning January 10, 2022 and continuing until the expiration of the head lease on August 30, 2024. The Company will account for this sublease as an operating lease in accordance with the lessor accounting guidance within ASC 842.

The components of lease expense consisted entirely of fixed lease costs related to operating leases. These costs were $89,623 and $89,623 for the six months ended June 30, 2022 and 2021, respectively. Fixed lease costs for the six months ended June 30, 2022 were offset by sublease income of $42,000.

Supplemental balance sheet information related to leases was as follows:


	As of June 30, 2022		As of December 31, 2021
Operating lease ROU asset:
Other assets	$	418,779	$	475,557

Operating lease liability:
Other current liabilities	$	133,462	$	125,579
Other long-term liabilities		336,108		405,018
Total operating lease liability	$	469,570	$	530,597

Supplemental lease term and discount rate information related to leases was as follows:


	As of June 30, 2022		As of December 31, 2021
Weighted-average remaining lease terms - operating leases	3.2 years		3.7 years
Weighted-average discount rate - operating leases	12.6	%	12.6	%

Supplemental cash flow information related to leases was as follows:


	For the Three Months				For the Six Months
	Ended June 30,				Ended June 30,
	2022		2021		2022		2021
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from operating leases	$	46,935	$	45,942	$	93,870	$	91,844

Future minimum lease payments under non-cancelable leases as of June 30, 2022, were as follows:


Lease Liability Maturity Analysis	Operating Leases
2022 (remaining 6 months)		93,870
2023		189,374
2024		155,242
2025		81,107
2026		82,324
Thereafter		—
Total lease payments		601,917
Less: Imputed Interest		(132,347)
Total	$	469,570

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Future minimum sublease income under non-cancelable leases as of June 30, 2022, were as follows:


Sublease income	Operating Leases
2022 (remaining 6 months)		42,000
2023		84,000
2024		56,000
Total	$	182,000

As of June 30, 2022, the Company had 0 operating leases that had not yet commenced.

15) Segment Information

The Company manages its operations through 2 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, and H100™ for the treatment of Peyronie’s disease. 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, 2022 are summarized as follows:


	Prescription		Medical
For the six months ended June 30, 2022	Medications		Devices		Corporate		Consolidated
Net sales	$	4,856,941	$	1,794,744	$	—	$	6,651,685
Cost of goods sold		489,007		632,553		—		1,121,560
Selling, general and administrative expenses		3,440,168		884,538		2,789,636		7,114,342
Gain on settlement of contingent liability		(3,389,941)		—		—		(3,389,941)
Research and development expenses		750,296		76,306		—		826,602
Depreciation and amortization expense		2,539,328		582,412		—		3,121,740
Change in fair value of derivative liability		—		—		(460,000)		(460,000)
Interest expense		—		—		303,398		303,398
Income tax expense		—		—		—		—
Net income (loss)	$	1,028,083	$	(381,065)	$	(2,633,034)	$	(1,986,016)

The Company’s results of operations by reportable segment for the six months ended June 30, 2021 are summarized as follows:


	Prescription		Medical
For the six months ended June 30, 2021	Medications		Devices		Corporate		Consolidated
Net sales	$	4,850,462	$	1,682,793	$	—	$	6,533,255
Cost of goods sold		562,328		474,352		—		1,036,680
Selling, general and administrative expenses		3,666,993		1,291,426		3,039,471		7,997,890
Research and development expenses		519,227		—		—		519,227
Depreciation and amortization expense		2,796,539		661,118		—		3,457,657
Change in fair value of derivative liability		—		—		(7,670,000)		(7,670,000)
Interest expense		—		—		288,937		288,937
Income tax expense		—		(6,700)		—		(6,700)
Net income (loss)	$	(2,694,625)	$	(750,803)	$	4,341,592	$	896,164

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The Company’s results of operations by reportable segment for the three months ended June 30, 2022 are summarized as follows:


	Prescription		Medical
For the three months ended June 30, 2022	Medications		Devices		Corporate		Consolidated
Net sales	$	3,332,173	$	854,343	$	—	$	4,186,516
Cost of goods sold		350,826		298,394		—		649,220
Selling, general and administrative expenses		1,729,149		220,947		1,266,508		3,216,604
Research and development expenses		344,936		76,306		—		421,242
Depreciation and amortization expense		1,269,665		291,205		—		1,560,870
Interest expense		—		—		150,372		150,372
Income tax expense		—		—		—		—
Net income (loss)	$	(362,403)	$	(32,509)	$	(1,416,880)	$	(1,811,792)

The Company’s results of operations by reportable segment for the three months ended June 30, 2021 are summarized as follows:


	Prescription		Medical
For the three months ended June 30, 2021	Medications		Devices		Corporate		Consolidated
Net sales	$	1,649,815	$	807,834	$	—	$	2,457,649
Cost of goods sold		173,047		220,247		—		393,294
Selling, general and administrative expenses		1,932,640		744,431		1,439,102		4,116,173
Research and development expenses		500,046		—		—		500,046
Depreciation and amortization expense		1,398,269		330,559		—		1,728,828
Change in fair value of derivative liability		—		—		(2,290,000)		(2,290,000)
Interest expense		—		—		115,525		115,525
Income tax expense		—		(6,700)		—		(6,700)
Net income (loss)	$	(2,354,187)	$	(494,103)	$	735,373	$	(2,112,917)

The following table reflects net sales by geographic region for the three and six months ended June 30, 2022 and 2021:


	For the Three Months Ended				For the Six Months Ended
	June 30,				June 30,
Net sales	2022		2021		2022		2021
United States	$	3,861,915	$	2,188,789	$	5,907,539	$	5,893,312
International		324,601		268,860		744,146		639,943
	$	4,186,516	$	2,457,649	$	6,651,685	$	6,533,255

No individual country other than the United States accounted for 10% of total sales for the three and six months ended June 30, 2022 and 2021.

The Company’s assets by reportable segment and reconciliation of segment assets to consolidated assets as of June 30, 2022, are summarized as follows:


	Prescription
	Medications		Medical Devices		Consolidated
Intangible assets, net	$	16,537,189	$	5,639,330	$	22,176,519
Total segment assets	$	43,586,828	$	7,463,115	$	51,049,943

The Company’s assets by reportable segment and reconciliation of segment assets to consolidated assets as of December 31, 2021, are summarized as follows:


	Prescription
	Medications		Medical Devices		Consolidated
Intangible assets, net	$	19,071,407	$	6,221,742	$	25,293,149
Total segment assets	$	59,657,514	$	7,732,544	$	67,390,058

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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

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, parenthetical references are made to relevant sections of the Notes to Consolidated Financial Statements to direct the reader to a further detailed discussion. This section should be read in conjunction with the 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 ended December 31, 2021.

Overview

Petros Pharmaceuticals, Inc. (“Petros” or the “Company”) 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”), Neurotrope, Inc. (“Neurotrope”), and Pos-T-Vac, LLC (“PTV”). 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 development 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. Stendra® is a U.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). Petros is also currently conducting non-clinical consumer studies in connection with the contemplated pursuit of FDA approval for Stendra® for Non-Prescription / Over-The-Counter (“OTC”) use in treating ED.

In addition to Stendra®, Petros’ ED portfolio also includes external penile rigidity devices, namely VEDs, which are sold domestically and internationally. In addition to ED products, Petros is committed to identifying and developing other pharmaceuticals to advance men’s health. In March 2020, Petros acquired an exclusive global license (the “Hybrid License”) for the development and commercialization of H100™ from Hybrid 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. On September 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 to March 24, 2021. In consideration for the extension, the Company paid Hybrid $50,000 in October 2020 and an additional $100,000 in December 2020. On March 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 to September 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. On September 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 on October 1, 2021, $200,000 on October 31, 2021, $200,000 on December 1, 2021, $200,000 on December 23, 2021 and $150,000 on March 24, 2022.

Impact of COVID-19

The World Health Organization (“WHO”) declared the coronavirus COVID-19 (“COVID-19”) a global pandemic on March 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. Accordingly, the COVID-19 pandemic may continue to have negative effects on the health of the U.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 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 2022 and beyond.

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Nature of Operations and Basis of Presentation

Petros is a pharmaceutical company focused on men’s health therapeutics with a full range of commercial capabilities including sales, marketing, regulatory and medical affairs, finance, trade relations, pharmacovigilance, market access relations, manufacturing, and distribution.

On December 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 of Neurotrope not retained by Neurotrope in connection with the Mergers were contributed to Synaptogenix, Inc. (formerly known as Neurotrope Bioscience, Inc.), a Delaware corporation (“Synaptogenix”), and a wholly-owned subsidiary of Neurotrope.

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 in the 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 on September 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 the U.S. and its territories, as well as 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 FDA in April 2012 to treat male ED.

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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 in April 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 September 30, 2016, which has since been terminated, effective as of September 30, 2021. 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.

The license agreement between MTPC and Vivus 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 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®.

On March 27, 2018, the Company entered into a Sublicense Agreement with Acerus Pharmaceuticals Corporation (“Acerus”) whereby the Company granted to Acerus an exclusive sublicense in Canada for, among other things, the development and commercialization of Stendra® avanafil for a one-time fee of $100,000. The Company was 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. However, in April 2020 Health Canada issued a Notice of Deficiency (“NOD”) against the New Drug Submission. Metuchen and Acerus are currently renegotiating modified terms to the sub-license agreement and the pathway required to address the deficiency noted by Health Canada.

In March 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. On September 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 to March 24, 2021. In consideration for the extension, the Company paid Hybrid $50,000 in October 2020 and an additional $100,000 in December 2020. On March 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 to September 24, 2021. Additionally, the Company agreed to pay Hybrid a one-time, non-creditable and non-refundable payment of two hundred thousand U.S. Dollars ($200,000), which was paid within seven calendar days of entering into the agreement. On September 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 on October 1, 2021, $200,000 on October 31, 2021, $200,000 on December 1, 2021, $200,000 on December 23, 2021 and $150,000 on March 24, 2022.

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Vivus Settlement Agreement, Promissory Note and the Security Agreement

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 API inventory under the Vivus Supply Agreement. In exchange for the API and reduction of current liabilities, Petros executed an interest-bearing promissory note (the “Note”) in favor of Vivus in the principal amount of $10,201,758, which approximate fair value. The parties also entered into a Security Agreement to secure Petros’ obligations under the Note.

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) financing issued by or to Metuchen (including any subsidiaries and intermediaries) 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 50% of the quantity of bulk Stendra® tablets under the Company’s existing open purchase order (the “Open Purchase Order”) being held by Vivus, which represents approximately a six-month supply of inventory. Pursuant to the Vivus Settlement Agreement Vivus also released the remaining 50% of the quantity of bulk Stendra® tablets under the Open Purchase Order, later during the first quarter of 2022, upon the Company’s satisfaction of the remaining regulatory submission requirements..

As a result of entering into the Vivus Settlement Agreement, the Company decreased the Company’s 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 six months ended June 30, 2022.

Under the terms of the Note, the principal amount of $10,201,758 is payable in consecutive quarterly installments beginning on April 1, 2022 through January 1, 2027. Interest on the principal amount will accrue at a rate of 6% per year until the principal is repaid in full and is due and payable, in arrears, on the first day of each January, April, July, and October of each calendar year, commencing on April 1, 2022. 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). If the Note is placed in the hands of any attorney for collection, or if it is collected through any legal proceeding at law or in equity or in bankruptcy, receivership, or other court proceedings, the Company will also be required to pay all costs of collection including, but not limited to, court costs and attorneys’ fees. 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. The Security Agreement contains customary events of default. For the six months ended June 30, 2022, the Company has paid Vivus $1,076,974. As of June 30, 2022, the principal balance on the Note is $10,024,785.

Nasdaq Minimum Bid Price Requirement

On June 22, 2022, we received a letter from the Listing Qualifications Department of the Nasdaq Stock Market (“Nasdaq”) indicating that, based upon the closing bid price of the Company’s common stock for the 30 consecutive business day period between May 9, 2022, through June 21, 2022, we 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 we will be provided with a compliance period of 180 calendar days, or until December 19, 2022 (the “Compliance Period”), in which to regain compliance pursuant to Nasdaq Listing Rule 5810(c)(3)(A).

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In order to regain compliance with Nasdaq’s minimum bid price requirement, our common stock must maintain a minimum closing bid price of $1.00 for at least ten consecutive business days during the Compliance Period. In the event we do not regain compliance by the end of the Compliance Period, we may be eligible for additional time to regain compliance. To qualify, we will be required to meet the continued listing requirement for the market value of its publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and will need to provide written notice of its intention to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary. If we meet these requirements, we may be granted an additional 180 calendar days to regain compliance. However, if it appears to The Nasdaq Capital Market that we will be unable to cure the deficiency, or if we are not otherwise eligible for the additional cure period, The Nasdaq Capital Market will provide notice that our common stock will be subject to delisting. We have not regained compliance as of the date of this report.

Critical Accounting Policies and Estimates

The preparation of the 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 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 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 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 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 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 contract returns, contract rebates and 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.

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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, distribution service fees, and cash discounts. Management determines each allowance based on historical experience along with the present knowledge of potentially uncollectible accounts.

Inventories

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.

In connection with the Mergers in December 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 the Monte Carlo Simulation approach as of June 30, 2022 and December 31, 2021. 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.

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. The Company has determined that no impairment exists as of June 30, 2022. As indicators of impairment exist as of June 30, 2022, the Company prepared an undiscounted cash flow analysis. This analysis includes projections of future revenue and expenses, which if not achieved could result in future impairment charges. These projections include continued significant sales growth resulting from newly manufactured product that has been distributed to the marketplace., Additionally, we are planning to continue investing in research and development pursuant to our OTC strategies related to Stendra®, which we anticipate will dramatically increase product sales in the future. Should we be unsuccessful or delayed in our expectations of our OTC strategies, there may be an impairment of the intangible asset.

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Recent Accounting Pronouncements

For a discussion of recent accounting pronouncements, refer to Note 2. Summary of Significant Accounting Policies of the Notes to Consolidated Financial Statements, which is incorporated herein by reference.

Results of Operations

The impact on our results of operations of the COVID-19 pandemic and related changes in economic conditions 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.

Six Months Ended June 30, 2022 and 2021 (Unaudited)

The following table sets forth a summary of our statements of operations for the six months ended June 30, 2022 and 2021:


	For the Six Months
	Ended June 30,
	2022		2021
Net sales	$	6,651,685	$	6,533,255
Cost of sales		1,121,560		1,036,680
Gross profit		5,530,125		5,496,575

Operating expenses:
Selling, general and administrative		7,114,342		7,997,890
Gain on settlement with Vivus		(3,389,941)		—
Research and development		826,602		519,227
Depreciation and amortization expense		3,121,740		3,457,657
Total operating expenses		7,672,743		11,974,774

Loss from operations		(2,142,618)		(6,478,199)

Change in fair value of derivative liability		460,000		7,670,000
Interest expense, senior debt		—		(288,937)
Interest expense, promissory note		(303,398)		—

Income (loss) before income taxes		(1,986,016)		902,864

Income tax expense (benefit)		—		6,700

Net income (loss)	$	(1,986,016)	$	896,164

Net Sales

Net sales for the six months ended June 30, 2022, were $6,651,685, composed of $4,856,941 of net sales from Prescription Medicines and net sales of $1,794,744 from Medical Devices.

Net sales for the six months ended June 30, 2021 were $6,533,255, composed of $4,850,462 of net sales from Prescription Medicines and net sales of $1,682,793 from Medical Devices.

For the six months ended June 30, 2022, gross sales to customers representing 10% or more of the Company’s total gross sales included four customers that represented approximately 26%, 23%, 18%, and 17% of total gross sales, respectively.

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For the six months ended June 30, 2021, gross sales to customers representing 10% or more of the Company’s total gross sales included two customers that represented approximately 49% and 14% of total gross sales.

Prescription Medicines sales consist of sales of Stendra® in the U.S. for the treatment of male ED. Stendra® is primarily sold directly to the four main customers as described above, which collectively accounted for approximately 94% of Stendra® net sales for the six months ended June 30, 2022. Individually, sales to the four main customers, accounted for 29%, 26%, 20%, and 19%, respectively, of Stendra® gross sales for the six months ended June 30, 2022.

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 $118,430 or 2% higher during the six months ended June 30, 2022 than in the same period in 2021 consisting of a $6,479 increase in the net sales of Stendra® and a $111,951 increase in Medical Device Sales. The increase in net sales of Stendra® was substantially due to increased wholesaler sales following the resolution of previous quarters supply constraints primarily offset by increased wholesaler returns related to the sale of short-dated product and increased distribution service fees. The increase in net sales for Medical Devices included an increase in international and domestic sales of VED systems.

Cost of Sales

Cost of sales for the six months ended June 30, 2022, were $1,121,560, composed of $489,007 of cost of sales for our Prescription Medicines segment and $632,553 for our Medical Devices segment.

Cost of sales for the six months ended June 30, 2021 were $1,036,680, composed of $562,328 of cost of sales for our Prescription Medicines segment and $474,352 for our Medical Devices segment.

Cost of sales for the Prescription Medicine segment for the six months ended June 30, 2022 consisted of 46% third-party product cost of sales, 50% royalty expenses, 7% 3PL order fulfillment and shipping expenses and a 3% benefit in inventory obsolescence reserves.

Cost of sales for the Medical Device segment for the six months ended June 30, 2022 consisted of 88% raw materials and 12% production labor.

Cost of sales increased by $84,880 or 8% during the six months ended June 30, 2022 compared to the same period in 2021. The increase in cost of sales coincides with the increase in revenues. For the six months ended June 30, 2022 and 2021, cost of sales as a percentage of net sales was 17% and 16%, respectively.

Gross Profit

Gross profit for the six months ended June 30, 2022 was $5,530,125, or 83% of net sales, composed of $4,367,934 of gross profit from Prescription Medicines and $1,162,191 from Medical Devices. Gross profit for the six months ended June 30, 2021 was $5,496,575, or 84% of net sales, composed of $4,288,134 of gross profit from Prescription Medicines and $1,208,441 from Medical Devices. The increase in gross profit was driven by the factors noted above.

Operating Expenses

Selling, general and administrative

Selling, general and administrative expenses for the six months ended June 30, 2022, were $7,114,342, composed of $3,440,168 of selling, general and administrative expenses of our Prescription Medicines segment, $884,538 of selling, general and administrative expenses of our Medical Devices segment and $2,789,636 of general corporate expenses.

Selling, general and administrative expenses for the six months ended June 30, 2021 were $7,997,890, composed of $3,666,993 of selling, general and administrative expenses of our Prescription Medicines segment, $1,291,426 of selling, general and administrative expenses of our Medical Devices segment and $3,039,471 of general corporate expenses.

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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 decreased by $883,548 or 11% during the six months ended June 30, 2022, compared to the same period in 2021. Decreased selling general and administrative expenses were primarily driven by decreased stock compensation expense of $279,616, decreased professional service fees of $235,553 as management sought to reduce expenses to improve operational efficiencies, lower payroll expenses of $44,536 resulting from decreased headcount, decreased bad debt expenses of $59,816 due to improved customer collections, decreased direct selling and marketing expenses of $59,679, and decreased other operating expenses of $204,348.

Gain on settlement with Vivus

As a result of the Vivus Promissory Note, as discussed in Note 8 and Note 13, the Company’s total liabilities were decreased by $3,389,941 in the form of concession of customer returns, which were recognized as a gain on settlement during the six months ended June 30, 2022. There was no such activity in the same period of 2021.

Research and development

Research and development expenses for the six months ended June 30, 2022 were $826,602, composed of $750,296 for our Prescription Medicines segment and $76,306 for our Medical Devices segment.

Research and development expenses for the six months ended June 30, 2021 were $519,227, composed of $519,227 for our Prescription Medicines segment and $0 for our Medical Devices segment.

Research and development expenses for the Prescription Medicines segment for the six months ended June 30, 2022 are composed of $390,456 for consulting fees related to the Company’s OTC strategies related to Stendra®; $150,000 for upfront licensing fees, $141,515 for clinical development expenses, and $40,456 for consulting fees related to the H100 license acquired in March 2020; and $27,869 related to the Company’s tech transfer of its manufacturing process. Research and development expenses for the Prescription Medicines segment for the six months ended June 30, 2021 are composed of $303,109 for consulting fees related to the Company’s OTC strategies, $200,000 for upfront licensing fees and $16,118 for legal fees related to the H100 license acquired in March 2020.

Research and development expenses for the Medical Devices segment for the six months ended June 30, 2022 are composed of $76,306 for license fees related to the Company’s Tissue-Specific Oxygenation Sensor Technology Strategies. Research and development expenses for the Medical Devices segment for the six months ended June 30, 2021 were $0.

Research and development expenses increased by $307,375 or 59% during the six months ended June 30, 2022, compared to the same period in 2021. Increased research and development expenses were primarily driven by increased clinical development expenses related to the H100 license acquired in March 2020, increased consulting fees related to the Company’s OTC strategies related to Stendra®, and increased license fees related to the Company’s Tissue-Specific Oxygenation Sensor Technology Strategies partially offset by decreased upfront licensing fees related to the H100 license acquired in March 2020.

Depreciation and amortization

Depreciation and amortization expenses for the six months ended June 30, 2022, were $3,121,740, composed of $2,539,328 of depreciation and amortization expenses of our Prescription Medicines segment and $582,412 of depreciation and amortization expenses of our Medical Devices segment.

Depreciation and amortization expenses for the six months ended June 30, 2021 were $3,457,657, composed of $2,796,539 of depreciation and amortization expenses of our Prescription Medicines segment and $661,118 of depreciation and amortization expenses of our Medical Devices segment.

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intangible assets related to Timm Medical and PTV over their estimated useful life of 12 years. The increase in amortization expense was primarily driven by the accelerated method of amortization related to the Stendra® product.

Change in fair value of derivative liability

In connection with the Mergers consummated on December 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 $460,000 represents the change in fair value of the derivative during the six months ended June 30, 2022, primarily driven by the decline in the Company’s stock price as well as the passage of time, as it became less likely that the earnout would be met.

Interest expense, senior debt

Interest expense, senior debt for the six months ended June 30, 2021 was $288,937 consisting of interest payments on our senior debt, with a weighted average balance of $4,785,655. The senior debt was repaid in 2021. There was no interest expense, senior debt for the six months ended June 30, 2022.

Interest expense, promissory note

In January 2022, the Company executed a promissory note in favor of Vivus with a principal amount of $10,201,758 as part of the settlement. Interest expense, promissory note for the six months ended June 30, 2022 was $303,398. There was no interest expense, promissory note for the six months ended June 30, 2021.

Three Months Ended June 30, 2022 and 2021 (unaudited)

The following table sets forth a summary of our statements of operations for the three months ended June 30, 2022 and 2021:


	For the Three Months
	Ended June 30,
	2022		2021
Net sales	$	4,186,516	$	2,457,649
Cost of sales		649,220		393,294
Gross profit		3,537,296		2,064,355

Operating expenses:
Selling, general and administrative		3,216,604		4,116,173
Gain on settlement with Vivus		—		—
Research and development		421,242		500,046
Depreciation and amortization expense		1,560,870		1,728,828
Total operating expenses		5,198,716		6,345,047

Loss from operations		(1,661,420)		(4,280,692)

Change in fair value of derivative liability		—		2,290,000
Interest expense, senior debt		—		(115,525)
Interest expense, promissory note		(150,372)		—
Loss before income taxes		(1,811,792)		(2,106,217)

Income tax expense (benefit)		—		6,700

Net income (loss)	$	(1,811,792)	$	(2,112,917)

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Net Sales

Net sales for the three months ended June 30, 2022, were $4,186,516, composed of $3,332,173 of net sales from Prescription Medicines and net sales of $854,343 from Medical Devices.

Net sales for the three months ended June 30, 2021 were $2,457,649, composed of $1,649,815 of net sales from Prescription Medicines and net sales of $807,834 from Medical Devices.

For the three months ended June 30, 2022, gross sales to customers representing 10% or more of the Company’s total gross sales included four customers that represented approximately 28%, 24% 23%, and 11% of total gross sales, respectively.

For the three months ended June 30, 2021, gross sales to customers representing 10% or more of the Company’s total gross sales included four customers that represented approximately 31%, 22% 17%, and 14% of total gross sales, respectively.

Prescription Medicines sales consist of sales of Stendra® in the U.S. for the treatment of male ED. Stendra® is primarily sold directly to the four main customers as described above, which collectively accounted for approximately 93% of Stendra® net sales for the three months ended June 30, 2022. Individually, sales to the four main customers, accounted for 30%, 26%, 25%, and 12%, respectively, of Stendra® gross sales for the three months ended June 30, 2022.

Net sales were $1,728,867 or 70% higher during the three months ended June 30, 2022 than in the same period in 2021 consisting of a $1,682,358 increase in the net sales of Stendra® and a $46,509 increase in Medical Device Sales. The increase in net sales of Stendra® was substantially due to increased wholesaler sales following the resolution of previous quarters supply constraints partially offset by increased wholesaler returns related to the sale of short-dated product. The increase in net sales for Medical Devices included an increase in international sales of VED systems partially offset by a decrease in domestic sales of VED systems.

Cost of Sales

Cost of sales for the three months ended June 30, 2022, were $649,220, composed of $350,826 of cost of sales for our Prescription Medicines segment and $298,394 for our Medical Devices segment.

Cost of sales for the three months ended June 30, 2021 were $393,294, composed of $173,047 of cost of sales for our Prescription Medicines segment and $220,247 for our Medical Devices segment.

Cost of sales for the Prescription Medicine segment for the three months ended June 30, 2022 consisted of 48% third-party product cost of sales, 48% royalty expenses, 9% 3PL order fulfillment and shipping expenses and a 5% benefit in inventory obsolescence reserves.

Cost of sales for the Medical Device segment for the three months ended June 30, 2022 consisted of 85% raw materials and 15% production labor.

Cost of sales increased by $255,926 or 65% during the three months ended June 30, 2022 compared to the same period in 2021. The increase in cost of sales coincides with the increase in revenues. For the three months ended June 30, 2022 and 2021, cost of sales as a percentage of net sales was 16% and 16%, respectively.

Gross Profit

Gross profit for the three months ended June 30, 2022 was $3,537,296, or 84% of net sales, composed of $2,981,347 of gross profit from Prescription Medicines and $555,949 from Medical Devices. Gross profit for the three months ended June 30, 2021 was $2,064,355, or 84% of net sales, composed of $1,476,768 of gross profit from Prescription Medicines and $587,587 from Medical Devices. The increase in gross profit was driven by the factors noted above.

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Operating Expenses

Selling, general and administrative

Selling, general and administrative expenses for the three months ended June 30, 2022, were $3,216,604, composed of $1,729,149 of selling, general and administrative expenses of our Prescription Medicines segment, $220,947 of selling, general and administrative expenses of our Medical Devices segment and $1,266,508 of general corporate expenses.

Selling, general and administrative expenses for the three months ended June 30, 2021 were $4,116,173, composed of $1,932,640 of selling, general and administrative expenses of our Prescription Medicines segment, $744,431 of selling, general and administrative expenses of our Medical Devices segment and $1,439,102 of general corporate expenses.

Selling, general and administrative expenses decreased by $899,569 or 22% during the three months ended June 30, 2022, compared to the same period in 2021. Decreased selling general and administrative expenses were primarily driven by decreased stock compensation expense of $288,235, decreased professional service fees of $225,529 as management sought to reduce expenses to improve operational efficiencies, lower payroll expenses of $102,025 resulting from decreased headcount, decreased bad debt expenses of $98,833 due to improved customer collections, decreased direct selling and marketing expenses of $16,153, and decreased other operating expenses of $168,794.

Research and development

Research and development expenses for the three months ended June 30, 2022, were $421,242, composed of $344,936 in our Prescription Medicines segment and $76,306 for our Medical Devices segment.

Research and development expenses for the three months ended June 30, 2021 were $500,046, in our Prescription Medicines segment and $0 for our Medical Devices segment.

Research and development expenses for the Prescription Medicines segment for the three months ended June 30, 2022 are composed of $198,891 for consulting fees related to the Company’s OTC strategies related to Stendra®; $108,094 for clinical development expenses and $10,081 for consulting fees related to the H100 license acquired in March 2020; and $27,869 related to the Company’s tech transfer of its manufacturing process. Research and development expenses for Prescription Medicines segment for the three months ended June 30, 2021 are composed of $283,928 for consulting fees related to the Company’s OTC strategies, $200,000 for upfront licensing fees and $16,118 for legal fees related to the H100 license acquired in March 2020.

Research and development expenses for the Medical Devices segment for the three months ended June 30, 2022 are composed of $76,306 for license fees related to the Company’s Tissue-Specific Oxygenation Sensor Technology Strategies. Research and development expenses for the Medical Devices segment for the three months ended June 30, 2021 were $0.

Research and development expenses decreased by $78,804 or 16% during the three months ended June 30, 2022, compared to the three months ended June 30, 2021. Decreased research and development expenses were primarily driven by decreased upfront licensing fees related to the H100 license acquired in March 2020 and decreased consulting fees related to the Company’s OTC strategies related to Stendra® partially offset by increased clinical development expenses related to the H100 license acquired in March 2020 and increased license fees related to the Company’s Tissue-Specific Oxygenation Sensor Technology Strategies.

Depreciation and amortization

Depreciation and amortization expenses for the three months ended June 30, 2022, were $1,560,870, composed of $1,269,665 of depreciation and amortization expenses of our Prescription Medicines segment and $291,205 of depreciation and amortization expenses of our Medical Devices segment.

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Depreciation and amortization expenses for the three months ended June 30, 2021 were $1,728,828, composed of $1,398,270 of depreciation and amortization expenses of our Prescription Medicines segment and $330,558 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. The increase in amortization expense was primarily driven by the accelerated method of amortization related to the Stendra® product.

Change in fair value of derivative liability

In connection with the Mergers consummated on December 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. The fair value of the derivative liability was reduced to $0 as of June 30, 2022.

Interest expense, senior debt

Interest expense, senior debt for the three months ended June 30, 2021 was $115,525 consisting of interest payments on our senior debt, with a weighted average balance of $3,974,107. The senior debt was repaid in 2021. There was no interest expense, senior debt for the three months ended June 30, 2022.

Interest expense, promissory note

In January 2022, the Company executed a promissory note in favor of Vivus with a principal amount of $10,201,758 as part of the settlement. Interest expense, promissory note for the three months ended June 30, 2022 was $150,372 consisting of accrued interest for payments on our promissory note. There was no interest expense, promissory note for the three months ended June 30, 2021.

Liquidity and Capital Resources

General

Cash on hand totaled $13,295,089 at June 30, 2022, compared to $23,847,572 at December 31, 2021.

We have experienced net losses and negative cash flows from operations since our inception. As of June 30, 2022, we had cash of $13 million, positive working capital of $15 million, and an accumulated deficit of $73 million. For the six months ended June 30, 2022, we used cash in operation of approximately $9.5 million. Our plans include, or may include, utilizing our 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 in the principal amount of $10,201,758. The terms of this promissory note are discussed in the section titled “—Vivus Settlement Agreement, Promissory Note and the Security Agreement” above. The Company believes the cash on hand is sufficient to fund its operations and debt service through at least August 16, 2023, however for periods after August 16, 2023, the Company may need to raise additional funds or curtail certain discretionary expenditures in order to maintain an appropriate level of cash to fund our operations. 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.

To date, our principal sources of capital used to fund our operations have been the revenues from product sales, private sales, registered offerings and private placements of equity securities.

In March 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

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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 and 6% of any net sales.

On September 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 to March 24, 2021. In consideration for the extension, the Company paid Hybrid $50,000 in October 2020 and an additional $100,000 in December 2020. On March 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 to September 24, 2021. Additionally, the Company agreed to pay Hybrid a one-time, non-creditable and non-refundable payment of two hundred thousand U.S. Dollars ($200,000), which was paid within seven calendar days of entering into the second letter agreement. On September 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 on October 1, 2021, $200,000 on October 31, 2021, $200,000 on December 1, 2021, $200,000 on December 23, 2021 and $150,000 on March 24, 2022.

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. The Company anticipates funding these future expenses through additional capital raises or issuance of debt, until revenues become sufficient to cover these ongoing expenses.

October 2021 Financing

On October 13, 2021, we entered into a Securities Purchase Agreement (the “October SPA”) with certain accredited and institutional investors, pursuant to which we sold 3,323,616 shares of our common stock in a registered direct offering (the “October RD”) at an offering price of $1.715 per share and associated October Warrant (as defined below). Also pursuant to the October SPA, in a concurrent private placement (together with the October RD, the “October Offering”), the Company sold to the purchasers warrants to purchase up to an aggregate of 3,323,616 shares of common stock at an exercise price of $1.715 per share (the “October Warrants”). The October Warrants became exercisable immediately upon the closing of the October Offering on October 18, 2021 and will expire five years following that date. In connection with the October Offering, the Company issued warrants to purchase 130,000 shares of common stock to Katalyst as compensation for financial advisory services. The Company received net proceeds from the October Offering, after deducting fees and other offering expenses payable by the Company, of approximately $5.5 million.

The October Warrants and the warrants issued to Katalyst in connection with the October Offering were issued in reliance upon the exemption from the registration requirements in Section 4(a)(2) of the Securities Act and Regulation D promulgated thereunder. Each purchaser represented that it was an “accredited investor” (as defined by Rule 501 under the Securities Act).

November 2021 Financing

On November 29, 2021, we entered into a Securities Purchase Agreement (the “November SPA”) with certain accredited and institutional investors, pursuant to which we sold 2,153,333 shares of our common stock in a registered direct offering (the “November RD) at an offering price of $3.00 per share and associated November Warrant (as defined herein). Also pursuant to the November SPA, in a concurrent private placement (together with the November RD, the “November Offering”), the Company sold to the purchasers (i) 1,180,000 unregistered shares of the Company’s common stock (the “November PIPE Shares) at an offering price of $3.00 per share and associated November Warrant and (ii) the warrants to purchase up to an aggregate of 2,500,000 shares of common stock at an exercise price of $3.50 per share (the “November Warrants”). The November Warrants became exercisable immediately upon the closing of the November Offering on December 2, 2021 and will expire five years following that date. In connection with the November Offering, the Company issued warrants to purchase 150,000 shares of common stock to Katalyst as compensation for financial advisory services. The Company received net proceeds from the November Offering, after deducting fees and other offering expenses payable by the Company, of approximately $9.3 million.

The November PIPE Shares, the November Warrants, and the warrants issued to Katalyst in connection with the November Offering were issued in reliance upon the exemption from the registration requirements in Section 4(a)(2) of the Securities Act and Regulation D promulgated thereunder. Each purchaser represented that it was an “accredited investor” (as defined by Rule 501 under the Securities Act).

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December 2021 Financing

On December 22, 2021, we entered into the Securities Purchase Agreement (the “December SPA”) with certain accredited and institutional investors, pursuant to which we sold 1,545,183 shares of our common stock in a registered direct offering (the “December RD) at an offering price of $3.43 per share and associated December Warrant (as defined herein). Also pursuant to the December SPA, in a concurrent private placement (together with the December RD, the “December Offering”), the Company sold to the purchasers (i) 641,406 unregistered shares of the Company’s common stock (the “December PIPE Shares) at an offering price of $3.43 per share and associated December Warrant and (ii) the warrants to purchase up to an aggregate of 1,639,942 shares of common stock at an exercise price of $3.50 per share (the “December Warrants”). The December Warrants became exercisable immediately upon the closing of the December Offering on December 27, 2021 and will expire five years following that date. In connection with the December Offering, the Company issued warrants to purchase 110,000 shares of common stock to Katalyst as compensation for financial advisory services. The Company received net proceeds from the December Offering, after deducting fees and other offering expenses payable by the Company, of approximately $6.9 million.

The December PIPE Shares, the December Warrants, and the warrants issued to Katalyst in connection with the December Offering were issued in reliance upon the exemption from the registration requirements in Section 4(a)(2) of the Securities Act and Regulation D promulgated thereunder. Each purchaser represented that it was an “accredited investor” (as defined by Rule 501 under the Securities Act).

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 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

Vivus Note

As noted above, in January 2022, the Company executed a promissory note in favor of Vivus with a principal amount of $10,201,758 as part of the settlement. For more information, see the section above titled “—Vivus Settlement Agreement, Promissory Note and the Security Agreement.”

Senior Debt

On September 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 included 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 was 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.

On November 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 $10,000,000 in principal.

On August 13, 2019, the Company entered into a forbearance agreement with Hercules under which Hercules agreed to forbear exercising any remedies under the loan for events of default through the earlier of September 30, 2019 or the occurrence of an event of default under the Loan Agreement, as amended.

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Effective April 13, 2020, the Company and Hercules entered into Amendment No. 2 to the Loan Agreement, (the “Second Amendment”), to extend the maturity date to December 1, 2021, if the Company should raise at least $20 million through an equity or debt financing or other transaction. All previously accrued PIK interest was added to principal, and no further PIK interest would accrue. The cash interest accrued at a rate of the greater of (i) the prime rate reported in the Wall Street Journal plus 11.50% minus 4.25% and (ii) 11.50%. The end of term charge of $1,068,750 was partially extended with $534,375 due on October 1, 2020, and $534,375 due on February 1, 2021. The Company incurred a $50,000 amendment fee upon closing of the Second Amendment.

Effective September 30, 2020, the Company and Hercules entered into Amendment No. 3 to the Loan Agreement (the “Third Amendment”) to provide for interest only payments commencing on October 1, 2020 and continuing through December 22, 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 JCP Investor, Hercules, and Wells 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 to Juggernaut Capital Partners III, L.P. and the Escrow Agreement was terminated.

On November 3, 2021, the Company repaid the remaining balance due on the Senior Debt.

Cash Flows

The following table summarizes our cash flows for the six months ended June 30 2022 and 2021:


	For the six Months
	Ended June 30,
	2022		2021
Net cash used in operating activities	$	9,475,509	$	2,346,366
Net cash used in financing activities		1,076,974		3,762,151
Net decrease in cash	$	10,552,483	$	6,108,517

Cash Flows from Operating Activities

Net cash used in operating activities for the six months ended June 30, 2022 was $9,475,509, which primarily reflected our net loss of $1,986,016, in addition to noncash adjustments to reconcile net loss to net cash used in operating activities of $13,982 consisting primarily of depreciation and amortization, the gain on the Vivus settlement, changes in the fair value of derivative liability and stock compensation, and changes in operating assets and liabilities of $7,475,511.

Net cash used in operating activities for the six months ended June 30, 2021 was $2,346,366, which primarily reflected our net income of $896,164, more than offset by cash adjustments to reconcile net income to net cash used in operating activities of $3,276,822 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 $34,294.

Cash Flows from Financing Activities

Net cash used in financing activities was $1,076,974 for the six months ended June 30, 2022, consisting of prepayments of promissory note of $1,076,974.

Net cash used in financing activities was $3,762,152 for the three months ended June 30, 2021, consisting of payments of senior debt of $3,227,914 and a payment for the senior debt end-of-term fee of $534,237.

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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.

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.

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The following table presents a reconciliation of net income (loss) to Adjusted EBITDA for the three and six months ended June 30, 2022 and 2021:


	For the Three Months Ended				For the Six Months Ended
	June 30,				June 30,
	2022		2021		2022		2021
Net income (loss)	$	(1,811,792)	$	(2,112,917)	$	(1,986,016)	$	896,164
Interest expense, senior debt		—		115,525		—		288,937
Interest expense, promissory note		150,372		—		303,398		—
Income tax expense (benefit)		—		6,700		—		6,700
Depreciation and amortization expense		1,560,870		1,728,828		3,121,740		3,457,657
EBITDA		(100,550)		(261,864)		1,439,122		4,649,458
Stock based compensation		302,267		680,504		658,093		1,125,511
Gain on settlement with Vivus		—		—		(3,389,941)		—
Change in fair value of derivative liability		—		(2,290,000)		(460,000)		(7,670,000)
Adjusted EBITDA	$	201,717	$	(1,871,360)	$	(1,752,726)	$	(1,895,031)

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 six months ended June 30, 2022 and 2021:


	For the Three Months Ended				For the Six Months Ended
	June 30				June 30
	2022		2021		2022		2021
Net Sales	$	4,186,516	$	2,457,649	$	6,651,685	$	6,533,255
Product Returns		3,620,326		1,203,062		4,364,079		1,812,767
Contract Rebates		308,208		1,050,748		758,439		1,922,482
Chargebacks		33,321		28,198		69,594		265,346
Cash Discounts		159,170		67,060		227,403		266,934
Distribution Service Fees		907,351		350,694		1,304,288		945,972
Coupon Redemptions		1,058,705		978,474		3,409,990		1,924,851
Gross Billings	$	10,273,597	$	6,135,885	$	16,785,478	$	13,671,607

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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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.

ITEM 4. CONTROLS AND PROCEDURES.

Evaluation of Disclosure Controls and Procedures

We carried out an evaluation, under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (“Exchange Act”)) as of the period covered by this report. Based upon that evaluation, our principal executive officer and principal financial officer concluded that, as of the end of the period covered in this Quarterly Report on Form 10-Q, our disclosure controls and procedures were not effective to ensure that information required to be disclosed in reports filed by us under the Exchange Act is recorded, processed, summarized and reported within the required time periods and is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.

A material weakness is a control deficiency (within the meaning of Public Company Accounting Oversight Board (PCAOB) Auditing Standard No. 5) or combination of control deficiencies that results in more than a remote likelihood that a material misstatement of the annual or interim financial statements will not be prevented or detected on a timely basis. As disclosed in Part II Item 9A Controls and Procedures in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021, we identified a material weaknesses in internal control related to (1) Petros has an insufficient level of monitoring and oversight controls and does not enforce the implementation of key controls reflected on its internal control process matrices; (2) the sizes of Petros’ accounting and IT departments make it impracticable to achieve an appropriate segregation of duties; and (3) Petros does not have appropriate IT access related controls.

Management plans to expand the scope of its remediation of its internal controls over financial reporting at the consolidated level and has developed a plan to address the remediation of the foregoing deficiencies in the second half of 2022. The Company has hired an external consultant to assist in the remediation of the deficiencies.

Our management, including our principal executive officer and principal financial officer, does not expect that our disclosure controls and procedures or our internal controls will prevent all errors or fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Due to the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. Management believes that the financial statements included in this Quarterly Report on Form 10-Q fairly present in all material respects our financial condition, results of operations and cash flows for the periods presented.

Changes in Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting that occurred during the quarter ended June 30, 2022, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting other than as noted above.

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PART II—OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS.

From time to time, we may become involved in legal proceedings or be subject to claims arising in the ordinary course of our business.

The information set forth in Note 14 Commitments and Contingencies of the Notes to Consolidated Financial Statements of this Quarterly Report on Form 10-Q is incorporated by reference herein.

ITEM 1A. RISK FACTORS.

The following description of risk factors includes any material changes to, and supersedes the description of, risk factors associated with our business, financial condition and results of operations previously disclosed in “Item 1A. Risk Factors” of our annual report on Form 10-K for the fiscal year ended December 31, 2021, as filed with the SEC on March 31, 2022. Our business, financial condition and operating results can be affected by a number of factors, whether currently known or unknown, including but not limited to those described in our annual report, any one or more of which could, directly or indirectly, cause our actual financial condition and operating results to vary materially from past, or from anticipated future, financial condition and operating results. Any of these factors, in whole or in part, could materially and adversely affect our business, financial condition, operating results, and stock price.

The following discussion of risk factors contains forward-looking statements. These risk factors may be important to understanding other statements in this Form 10-Q. The following information should be read in conjunction with the condensed consolidated financial statements and related notes in Part I, Item 1, “Financial Statements” and Part I, Item 2, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” of this Form 10-Q.

Risks Related to Our Common Stock

Our failure to meet the continued listing requirements of The Nasdaq Capital Market could result in a delisting of our common stock.

As previously reported, on June 22, 2022, we received a letter from Nasdaq indicating that, based upon the closing bid price of the Company’s common stock for the 30 consecutive business day period between May 9, 2022, through June 21, 2022, we 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). In order to regain compliance with Nasdaq’s minimum bid price requirement, our common stock must maintain a minimum closing bid price of $1.00 for at least ten consecutive business days during the Compliance Period. In the event that we do not regain compliance by the end of the Compliance Period, we may be eligible for additional time to regain compliance. To qualify, we will be required to meet the continued listing requirement for the market value of its publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and will need to provide written notice of its intention to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary. If we meet these requirements, we may be granted an additional 180 calendar days to regain compliance. However, if it appears to Nasdaq that we will be unable to cure the deficiency, or if we are not otherwise eligible for the additional cure period, Nasdaq will provide notice that our common stock will be subject to delisting.

To resolve the noncompliance, we may consider available options including a reverse stock split, which may not result in a permanent increase in the market price of our common stock, which is dependent on many factors, including general economic, market and industry conditions and other factors detailed from time to time in the reports we file with the SEC. It is not uncommon for the market price of a company’s shares to decline in the period following a reverse stock split.

Although we expect to take actions intended to restore our compliance with the listing requirements, we can provide no assurance that any action taken by us would be successful, or that any such action would stabilize the market price or improve the liquidity of our common stock. Should a delisting occur, an investor would likely find it significantly more difficult to dispose of, or to obtain accurate quotations as to the value of our common stock, and our ability to raise future capital through the sale of our common stock could be severely limited.

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ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.

Issuance of Unregistered Securities

None.

ITEM 3. DEFAULTS UPON SENIOR SECURITIES.

None.

ITEM 4. MINE SAFETY DISCLOSURES.

Not applicable.

ITEM 5. OTHER INFORMATION.

None.

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ITEM 6. EXHIBITS.

Exhibit No.		Description
31.1*		Rule 13a-14(a)/15d-14(a) Certification – Principal Executive Officer.
31.2*		Rule 13a-14(a)/15d-14(a) Certification – Principal Financial Officer.
32**		Section 1350 Certification – Principal Executive Officer and Principal Financial Officer.
101		The following materials from Petros Pharmaceuticals, Inc.’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, formatted in iXBRL (Inline eXtensible Business Reporting Language): (i) Consolidated Balance Sheets; (ii) Consolidated Statements of Operations; (iii) Consolidated Changes in Stockholders’ Equity/Members’ Capital; (iv) Consolidated Statements of Cash Flows; and (v) Notes to the Consolidated Financial Statements.
104		Cover Page Interactive Data File, formatted in iXBRL and contained in Exhibit 101.

*	Filed herewith.

**	Furnished herewith.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

	Petros Pharmaceuticals, Inc.

Date: August 12, 2022	By:	/s/ Fady Boctor
		Fady Boctor
		Chief Commercial Officer and Principal Executive Officer

Date: August 12, 2022	By:	/s/ Mitchell Arnold
		Mitchell Arnold
		Vice President of Finance and Principal Financial Officer

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Petros Pharmaceuticals (PTPI) 10-Q2022 Q2 Quarterly report

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