Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2022 | May 05, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2022 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q1 | |
Document Transition Report | false | |
Entity File Number | 001-40492 | |
Entity Registrant Name | Femasys Inc. | |
Entity Central Index Key | 0001339005 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 11-3713499 | |
Entity Address, Address Line One | 3950 Johns Creek Court, Suite 100 | |
Entity Address, City or Town | Suwanee | |
Entity Address, State or Province | GA | |
Entity Address, Postal Zip Code | 30024 | |
City Area Code | 770 | |
Local Phone Number | 500-3910 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Shell Company | false | |
Title of 12(b) Security | Common stock, $0.001 par value | |
Trading Symbol | FEMY | |
Security Exchange Name | NASDAQ | |
Entity Common Stock, Shares Outstanding | 11,813,610 |
Balance Sheets
Balance Sheets - USD ($) | Mar. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 21,767,634 | $ 24,783,029 |
Accounts receivable, net | 170,302 | 84,258 |
Inventory, net | 223,008 | 208,270 |
Other current assets | 567,300 | 555,853 |
Total current assets | 22,728,244 | 25,631,410 |
Property and equipment, at cost: | ||
Leasehold improvements | 1,195,637 | 1,155,332 |
Office equipment | 99,344 | 99,344 |
Furniture and fixtures | 424,947 | 424,947 |
Machinery and equipment | 2,287,126 | 2,261,793 |
Construction in progress | 434,443 | 379,713 |
Property and equipment, gross | 4,441,497 | 4,321,129 |
Less accumulated depreciation | (2,854,315) | (2,722,117) |
Net property and equipment | 1,587,182 | 1,599,012 |
Long-term assets: | ||
Lease right-of-use assets, net | 574,943 | 665,747 |
Intangible assets, net of accumulated amortization | 17,663 | 25,093 |
Other long-term assets | 625,418 | 655,418 |
Total long-term assets | 1,218,024 | 1,346,258 |
Total assets | 25,533,450 | 28,576,680 |
Current liabilities: | ||
Accounts payable | 548,377 | 445,522 |
Accrued expenses | 565,228 | 603,787 |
Clinical holdback - current portion | 36,238 | 18,947 |
Note payable - current portion | 45,666 | 181,123 |
Lease liabilities - current portion | 400,620 | 406,674 |
Other - current | 36,037 | 36,037 |
Total current liabilities | 1,632,166 | 1,692,090 |
Long-term liabilities: | ||
Clinical holdback - long-term portion | 102,502 | 149,791 |
Lease liabilities - long-term portion | 305,071 | 402,417 |
Total long-term liabilities | 407,573 | 552,208 |
Total liabilities | 2,039,739 | 2,244,298 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Common stock, $.001 par, 200,000,000 authorized, 11,921,388 shares issued and 11,804,165 outstanding as of March 31, 2022 and December 31, 2021 | 11,921 | 11,921 |
Treasury stock, 117,223 shares | (60,000) | (60,000) |
Warrants | 702,492 | 702,492 |
Additional paid-in-capital | 108,462,663 | 108,418,304 |
Accumulated deficit | (85,623,365) | (82,740,335) |
Total stockholders' equity | 23,493,711 | 26,332,382 |
Total liabilities and stockholders' equity | $ 25,533,450 | $ 28,576,680 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2022 | Dec. 31, 2021 |
Stockholders' equity: | ||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, authorized (in shares) | 200,000,000 | 200,000,000 |
Common stock, issued (in shares) | 11,921,388 | 11,921,388 |
Common stock, outstanding (in shares) | 11,804,165 | 11,804,165 |
Treasury stock, shares (in shares) | 117,223 | 117,223 |
Statements of Comprehensive Los
Statements of Comprehensive Loss - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Statements of Comprehensive Loss [Abstract] | ||
Sales | $ 321,405 | $ 329,775 |
Cost of sales | 122,675 | 93,042 |
Gross margin | 198,730 | 236,733 |
Operating expenses: | ||
Research and development | 1,421,063 | 995,022 |
Sales and marketing | 68,863 | 22,819 |
General and administrative | 1,447,355 | 891,987 |
Depreciation and amortization | 144,199 | 153,453 |
Total operating expenses | 3,081,480 | 2,063,281 |
Loss from operations | (2,882,750) | (1,826,548) |
Other income (expense): | ||
Interest income, net | 2,454 | 164 |
Interest expense | (2,734) | (3,848) |
Other expense, net | (280) | (3,684) |
Net loss | (2,883,030) | (1,830,232) |
Net loss attributable to common stockholders, basic (in dollars per share) | (2,883,030) | (1,830,232) |
Net loss attributable to common stockholders, diluted (in dollars per share) | $ (2,883,030) | $ (1,830,232) |
Net loss per share attributable to common stockholders, basic (in dollars per share) | $ (0.24) | $ (1.84) |
Net loss per share attributable to common stockholders, diluted (in dollars per share) | $ (0.24) | $ (1.84) |
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic (in shares) | 11,804,165 | 995,208 |
Weighted-average shares used in computing net loss per share attributable to common stockholders, diluted (in shares) | 11,804,165 | 995,208 |
Statements of Stockholders' Equ
Statements of Stockholders' Equity (Deficit) - USD ($) | Common Stock [Member] | Treasury Stock [Member] | Preferred Stock [Member] | Warrants [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Total | Series B and Series C Redeemable Convertible Preferred Stock [Member] |
Balance at Dec. 31, 2020 | $ 55,343,686 | |||||||
Balance (in shares) at Dec. 31, 2020 | 55,835,833 | |||||||
Increase (Decrease) in Temporary Equity [Roll Forward] | ||||||||
Share-based compensation expense | $ 0 | |||||||
Net loss | 0 | |||||||
Balance at Mar. 31, 2021 | $ 55,343,686 | |||||||
Balance (in shares) at Mar. 31, 2021 | 55,835,833 | |||||||
Balance at Dec. 31, 2020 | $ 1,110 | $ (60,000) | $ 17,211 | $ 702,492 | $ 22,725,949 | $ (75,202,490) | $ (51,815,728) | |
Balance (in shares) at Dec. 31, 2020 | 1,110,347 | 117,223 | 17,210,609 | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of common stock for cash upon exercise of options | $ 2 | $ 0 | $ 0 | 0 | 10,048 | 0 | 10,050 | |
Issuance of common stock for cash upon exercise of options (in shares) | 2,084 | 0 | 0 | |||||
Share-based compensation expense | $ 0 | $ 0 | $ 0 | 0 | 72,490 | 0 | 72,490 | |
Net loss | 0 | 0 | 0 | 0 | 0 | (1,830,232) | (1,830,232) | |
Balance at Mar. 31, 2021 | $ 1,112 | $ (60,000) | $ 17,211 | 702,492 | 22,808,487 | (77,032,722) | (53,563,420) | |
Balance (in shares) at Mar. 31, 2021 | 1,112,431 | 117,223 | 17,210,609 | |||||
Balance at Dec. 31, 2021 | $ 0 | |||||||
Balance (in shares) at Dec. 31, 2021 | 0 | |||||||
Increase (Decrease) in Temporary Equity [Roll Forward] | ||||||||
Share-based compensation expense | $ 0 | |||||||
Net loss | 0 | |||||||
Balance at Mar. 31, 2022 | $ 0 | |||||||
Balance (in shares) at Mar. 31, 2022 | 0 | |||||||
Balance at Dec. 31, 2021 | $ 11,921 | $ (60,000) | $ 0 | 702,492 | 108,418,304 | (82,740,335) | 26,332,382 | |
Balance (in shares) at Dec. 31, 2021 | 11,921,388 | 117,223 | 0 | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Share-based compensation expense | $ 0 | $ 0 | $ 0 | 0 | 44,359 | 0 | 44,359 | |
Net loss | 0 | 0 | 0 | 0 | 0 | (2,883,030) | (2,883,030) | |
Balance at Mar. 31, 2022 | $ 11,921 | $ (60,000) | $ 0 | $ 702,492 | $ 108,462,663 | $ (85,623,365) | $ 23,493,711 | |
Balance (in shares) at Mar. 31, 2022 | 11,921,388 | 117,223 | 0 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (2,883,030) | $ (1,830,232) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 136,769 | 141,202 |
Amortization | 7,430 | 12,251 |
Amortization of right-of-use assets | 86,233 | 98,256 |
Inventory reserve | 2,700 | 0 |
Share-based compensation expense | 44,359 | 72,490 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (86,044) | 30,043 |
Inventory | (17,438) | (12,679) |
Other assets | 18,553 | 63,081 |
Accounts payable | 102,855 | 171,665 |
Accrued expenses and other | (38,559) | 194,506 |
Lease liabilities | (97,851) | (105,986) |
Other liabilities | (29,998) | 4,721 |
Net cash used in operating activities | (2,754,021) | (1,160,682) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (120,368) | 0 |
Net cash used in investing activities | (120,368) | 0 |
Cash flows from financing activities: | ||
Payments of deferred offering costs | 0 | (126,377) |
Proceeds from issuance of common stock | 0 | 10,050 |
Repayment of note payable | (135,457) | (23,643) |
Payments under lease obligations | (5,549) | (5,021) |
Net cash used in financing activities | (141,006) | (144,991) |
Net change in cash and cash equivalents | (3,015,395) | (1,305,673) |
Cash and cash equivalents: | ||
Beginning of period | 24,783,029 | 3,322,226 |
End of period | 21,767,634 | 2,016,553 |
Cash paid for: | ||
Interest | 2,734 | 1,845 |
Income taxes | 800 | 0 |
Non-cash financing activities: | ||
Deferred offering costs included in accounts payable and accrued expenses | 0 | 526,476 |
Prepaid insurance financed with promissory notes | $ 45,666 | $ 41,199 |
Organization, Nature of Busines
Organization, Nature of Business, and Liquidity | 3 Months Ended |
Mar. 31, 2022 | |
Organization, Nature of Business, and Liquidity [Abstract] | |
Organization, Nature of Business, and Liquidity | (1) Organization, Nature of Business, and Liquidity Organization and Nature of Business Femasys Inc. (the Company or Femasys) was incorporated in Delaware on February 19, 2004 and is headquartered in Suwanee, Georgia. The Company is a biomedical company focused on transforming women’s healthcare by developing novel solutions and next-generation advancements providing significant clinical impact to address severely underserved areas. Our mission is to provide women worldwide with superior minimally-invasive, non-surgical product technologies, accessible in the office, improving patient care and overall health economics. The Company currently operates as one segment and is primarily focused on servicing the reproductive health needs for those seeking permanent birth control or solutions for infertility issues. F emasys has an expansive intellectual property portfolio which covers both design and utility patents in the U.S. and significant ex-U.S. markets for each product initiative. Femasys has taken concepts internally conceived and protected through development, including domestic and foreign regulatory approvals, and production, through in-house manufacturing. FemBloc® (FemBloc), the Company’s solution for permanent birth control, is based on the Company’s non-surgical platform technology and is presently completing a validation study under an approved Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA). FemaSeed™ (FemaSeed), a solution which enables directed intrauterine insemination to improve on traditional intrauterine insemination (IUI) and provide a lower cost option to in vitro fertilization methods, received approval in April 2021 from the FDA on its IDE and the clinical study was initiated in July 2021. FemVue® (FemVue), a solution that enables fallopian tube assessment with ultrasound as an alternative to the radiologic approach (hysterosalpingogram) for the diagnosis of infertility, is approved for sale in the U.S., Europe, Japan, and Canada. FemChec® (FemChec), allows for fallopian tube evaluation after a FemBloc procedure to confirm occlusion (or procedure success) and is part of the FemBloc validation study. FemCerv® (FemCerv) is a solution for complete tissue sampling with minimal contamination of the endocervical canal as an alternative to the single biopsy method, is approved for sale in the U.S. and Europe. FemCath™ (FemCath), allows for selective evaluation of an individual fallopian tube as an alternative to the traditional intrauterine catheter that is undirected, is approved for sale in the U.S. Basis of Presentation The Company has prepared the accompanying financial statements pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (SEC). Certain information and footnote disclosures normally included in the annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) have been condensed or omitted pursuant to these rules and regulations. These financial statements should be read in conjunction with the Company’s audited financial statements and footnotes related thereto for the year ended December 31, 2021 included in our Annual Report on Form 10K filed with the SEC on March 24, 2022 (the Annual Report). In the opinion of management, the unaudited financial statements include all adjustments (consisting only of normal recurring adjustments) necessary to present fairly the Company’s financial position and the results of its operations and cash flows at the dates for periods presented. The results of operations for such interim periods are not necessarily indicative of the results to be expected for the full year. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expense during the reporting periods. The most significant estimates used in these financial statements include the valuation of stock options, warrants, useful lives of property and equipment, intangible assets, and the pre-IPO valuation of our common stock and preferred stock. Estimates for these and other items are subject to change and are reassessed by management in accordance with U.S. GAAP. Actual results could differ from those estimates. Liquidity As of March 31, 2022, the Company has cash and cash equivalents of $21,767,634. The Company plans to finance its operations and development needs with its existing cash and cash equivalents, additional equity and/or debt financing arrangements, and revenue from the sale of FemVue to support the Company’s research and development activities, largely in connection with FemBloc and FemaSeed. There can be no assurance that the Company will be able to obtain additional financing on terms acceptable to the Company, on a timely basis, or at all. If the Company is not able to obtain sufficient funds on acceptable terms when needed, the Company’s business, results of operations, and financial condition could be materially adversely impacted. For the three months ended March 31, 2022, the Company generated a net loss of $2,883,030. The Company expects such losses to increase over the next few years as the Company advances FemBloc and FemaSeed through clinical development until FDA approval is received and the products are available to be marketed. The Company believes that its cash and cash equivalents as of March 31, 2022 will be sufficient to fund our ongoing operations at least 12 months from the date of filing these financial statements. Recently Issued Accounting Pronouncements – Recently Adopted On January 1, 2021, the Company adopted Accounting Standards Update (ASU) 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes Recently Issued Accounting Pronouncements – Not Yet Adopted In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses Measurement of Credit Losses on Financial Instruments No other new accounting pronouncement issued or effective has had, or is expected to have, a material impact on the Company’s financial statements. |
Cash and Cash Equivalents
Cash and Cash Equivalents | 3 Months Ended |
Mar. 31, 2022 | |
Cash and Cash Equivalents [Abstract] | |
Cash and Cash Equivalents | (2) Cash and Cash Equivalents As of March 31, 2022 and December 31, 2021, money market funds included in cash and cash equivalents on the balance sheets were $21,424,306 and $24,388,443, respectively, which represent level 1 within the fair value hierarchy where there are quoted prices in active markets for identical assets. |
Inventories
Inventories | 3 Months Ended |
Mar. 31, 2022 | |
Inventories [Abstract] | |
Inventories | (3) Inventories Inventory stated at cost, net of reserve, consisted of the following: March 31, 2022 December 31, 2021 Materials $ 132,185 111,531 Work in progress 55,709 12,795 Finished goods 35,114 83,944 Inventory, net $ 223,008 208,270 The FemVue reserve for slow moving, obsolete, or unusable inventories was as of March 31, 2022 and December 31, 2021, respectively. |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2022 | |
Accrued Expenses [Abstract] | |
Accrued Expenses | (4) Accrued Expenses Accrued expenses consisted of the following: March 31, 2022 December 31, 2021 Clinical trial costs $ 324,329 301,730 Compensation costs 127,873 98,272 Franchise taxes 16,500 103,020 Other 96,526 100,765 Accrued expenses $ 565,228 603,787 |
Clinical Holdback
Clinical Holdback | 3 Months Ended |
Mar. 31, 2022 | |
Clinical Holdback [Abstract] | |
Clinical Holdback | (5) Clinical Holdback The following table shows the activity within the clinical holdback liability accounts for the three months ended March 31, 2022: Balance at December 31, 2021 $ 168,738 Clinical holdback retained 4,023 Clinical holdback paid (34,021 ) Balance at March 31 2022 $ 138,740 Less: clinical holdback - current portion (36,238 ) Clinical holdback - long-term portion $ 102,502 |
Revenue Recognition
Revenue Recognition | 3 Months Ended |
Mar. 31, 2022 | |
Revenue Recognition [Abstract] | |
Revenue Recognition | (6) Revenue Recognition Revenue is recognized upon shipment of our goods based upon contractually stated pricing at standard payment terms ranging from 30 to 60 days. All revenue is recognized point in time and no revenue is recognized over time. For the three months ended March 31, 2022 and 2021, there was no revenue recognized from performance obligations satisfied or partially satisfied in prior periods, nor were there any unsatisfied performance obligations as of March 31, 2022 or 2021. The majority of products sold directly to U.S customers are shipped via common carrier, and the customer pays for shipping and handling and assumes control Free on Board (FOB) shipping point. Products shipped to our international distributors are in accordance with their respective agreements; however, the shipping terms are generally EX-Works, reflecting that control is assumed by the distributor at the shipping point. Returns are only accepted with prior authorization from the Company. Items to be returned must be in original unopened cartons and are subject to a 30% restocking fee. Throughout the periods presented, the Company has not had a history of significant returns. The following table summarizes our FemVue sales by geographic region as follows: Three Months Ended March 31, 2022 2021 Primary geographical markets U.S. $ 263,360 271,730 International 58,045 58,045 Total $ 321,405 329,775 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2022 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | (7) Commitments and Contingencies Legal Claims Occasionally, the Company may be a party to legal claims or proceedings of which the outcomes are subject to significant uncertainty. In accordance with Accounting Standards Codification Contingencies The Company, as permitted under Delaware law and in accordance with its bylaws, indemnifies its officers and directors for certain events or occurrences, subject to certain limits, while the officer or director is or was serving at the Company’s request in such capacity. The Company entered into employment agreements with its officers, which provides for indemnification protection in the executive’s capacity as an officer for actions taken within the scope of employment. The maximum amount of potential future indemnification is unlimited; however, the Company has obtained director and officer insurance that limits its exposure. The Company believes the fair value for these indemnification obligations is minimal. Accordingly, the Company has not recognized any liabilities relating to these obligations as of March 31, 2022 and December 31, 2021. |
Notes Payable
Notes Payable | 3 Months Ended |
Mar. 31, 2022 | |
Notes Payable [Abstract] | |
Notes Payable | (8) Notes Payable AFCO Credit Corporation (AFCO) As of March 31, 2022 and December 31, 2021, the principal balance on the remaining AFCO promissory note was $45,666 and $181,123, respectively and is included in Notes payable – current portion in the accompanying balance sheets. Interest expense in connection with the AFCO promissory notes was $1,796 and $378 for the three months ended March 31, 2022 and 2021, respectively. |
Redeemable Convertible Preferre
Redeemable Convertible Preferred Stock and Stockholders' Equity | 3 Months Ended |
Mar. 31, 2022 | |
Redeemable Convertible Preferred Stock and Stockholders' Equity [Abstract] | |
Redeemable Convertible Preferred Stock and Stockholders' Equity | (9) Redeemable Convertible Preferred Stock and Stockholders’ Equity In June 2021, the Company issued 2,650,000 shares of common stock in connection with the Company’s IPO of its common stock at $13.00 per share. Net proceeds to the Company, after deducting underwriting discounts, commissions, and legal expenses, was $31,613,500. Offering costs incurred by the company were $2,016,143 , which include legal expenses incurred and paid by our underwriters of $425,000. The Company filed an eleventh amended and restated certificate of incorporation (the Amended and Restated Certificate) with the Secretary of State of the State of Delaware in connection with the completion of the IPO on June 22, 2021. The Amended and Restated Certificate amends and restates the Company’s existing certificate of incorporation in its entirety to, among other things: (i) authorize 200,000,000 shares of common stock; (ii) eliminate all references to the previously-existing series of preferred stock (Series A, B and C); and (iii) authorize 10,000,000 shares of undesignated preferred stock that may be issued from time to time by the Board in one or more series. As of March 31, 2022, the Company had 11,804,165 shares of common stock outstanding, and no dividends have been declared or paid. |
Equity Incentive Plans
Equity Incentive Plans | 3 Months Ended |
Mar. 31, 2022 | |
Equity Incentive Plans [Abstract] | |
Equity Incentive Plans | (10) Equity Incentive Plans Stock-Based Awards (a) Stock Option Plans In June 2021, in connection with the IPO, our 2021 Equity Incentive Plan (2021 Plan) became effective, which was adopted by our Board of Directors in February 2021 and our stockholders approved the 2021 Plan in March 2021. The 2021 Plan is administered by our compensation committee. Upon the effectiveness of the 2021 Plan, no new grants will be awarded under our 2015 Stock-Based Incentive Compensation Plan. As of March 31, 2022, the total number of shares of common stock reserved for future awards under the 2021 Plan is 1,319,136. Activity under the stock option plans was as follows: Number of options Weighted average exercise price Weighted average remaining contracted term in years Aggregate intrinsic value Outstanding at December 31, 2021 689,995 $ 3.58 $ 683,531 Granted 270,170 6.71 Expired (3,334 ) 27.00 Forfeited (834 ) 6.12 Outstanding at March 31, 2022 955,997 $ 4.38 6.47 $ 125,279 Vested and exercisable at March 31, 2022 529,027 $ 3.65 5.21 $ 64,168 Options granted under our 2021 Plan for the three months ended March 31, 2022 to employees and a nonemployee were 253,170 and 17,000, respectively, and the weighted average exercise prices were $6.96 and $3.03, respectively. Included in awards granted to employees are 140,000 of performance based options that vest on achieving certain clinical related milestones. The weighted-average weighted-average Employee Nonemployee Expected term (in years) 6.47 6.00 Risk‑free interest rate 1.74 % 1.64 % Dividend yield — % — % Expected volatility 107.23 % 107.78 % No options were exercised for the three months ended March 31, 2022 under our stock option plans. (b) Inducement Grant On February 28, 2022, the Company awarded, outside the 2021 Plan, our Chief Financial Officer a stock option grant for the right to purchase 100,000 shares of common stock at an exercise price of $2.97 per share (inducement grant), which was approved by the Compensation Committee. The inducement grant will vest in equal installments over four years provided the employee remains employed by the Company on the vesting date. The fair value of the inducement grant was $2.46 and was estimated using the following assumptions: Inducement Expected term (in years) 6.25 Risk‑free interest rate 1.76 % Dividend yield — % Expected volatility 106.76 % As of March 31, 2022, 100,000 shares are outstanding, and none are exercisable. (c) Share-Based Compensation Expense The following table shows the share-based compensation expense related to vested stock option grants to employees and nonemployees by financial statement line item on the accompanying statement of comprehensive loss: Three Months Ended March 31, 2022 2021 Research and development $ 29,139 35,496 Sales and marketing 1,126 926 General and administrative 14,094 36,068 Total share-based compensation expense $ 44,359 72,490 As March 31, 2022, the remaining share-based compensation expense that is expected to be recognized in future periods for employees and nonemployees is $1,122,943, which includes $463,311 of compensation expense to be recognized upon achieving certain performance conditions. For service based awards, the $659,632 of unrecognized expense is expected to be recognized over a weighted average period of 3.4 years. (d) Employee Stock Purchase Plan In June 2021, in connection with the IPO, our Employee Stock Purchase Plan (ESPP) became effective which was adopted by our Board of Directors in February 2021 and our stockholders approved the 2021 ESPP Plan in March 2021. The ESPP is administered by our compensation committee. As of March 31, 2022, the total number of shares of common stock reserved for future awards under the ESPP Plan is 284,707, and no shares of our common stock have been purchased under the ESPP. |
Net Loss per Share Attributable
Net Loss per Share Attributable to Common Stockholders | 3 Months Ended |
Mar. 31, 2022 | |
Net Loss per Share Attributable to Common Stockholders [Abstract] | |
Net Loss per Share Attributable to Common Stockholders | (11) Net Loss per Share Attributable to Common Stockholders The following table sets forth the computation of the basic and diluted net loss per share: Three Months Ended March 31, 2022 2021 Net loss attributable to common stockholders, basic & diluted $ (2,883,030 ) (1,830,232 ) Weighted average number of shares used in computing net loss per share attributable to common stockholders, basic and diluted 11,804,165 995,208 Net loss per share attributable to common stockholders, basic and diluted $ (0.24 ) (1.84 ) The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding because they would be anti-dilutive March 31, 2022 March 31, 2021 Convertible preferred stock outstanding — 8,116,343 Options to purchase common stock 1,055,997 740,444 Warrants to purchase to common stock 244,572 244,572 Total potential shares 1,300,569 9,101,359 |
Organization, Nature of Busin_2
Organization, Nature of Business, and Liquidity (Policies) | 3 Months Ended |
Mar. 31, 2022 | |
Organization, Nature of Business, and Liquidity [Abstract] | |
Organization and Nature of Business | Organization and Nature of Business Femasys Inc. (the Company or Femasys) was incorporated in Delaware on February 19, 2004 and is headquartered in Suwanee, Georgia. The Company is a biomedical company focused on transforming women’s healthcare by developing novel solutions and next-generation advancements providing significant clinical impact to address severely underserved areas. Our mission is to provide women worldwide with superior minimally-invasive, non-surgical product technologies, accessible in the office, improving patient care and overall health economics. The Company currently operates as one segment and is primarily focused on servicing the reproductive health needs for those seeking permanent birth control or solutions for infertility issues. F emasys has an expansive intellectual property portfolio which covers both design and utility patents in the U.S. and significant ex-U.S. markets for each product initiative. Femasys has taken concepts internally conceived and protected through development, including domestic and foreign regulatory approvals, and production, through in-house manufacturing. FemBloc® (FemBloc), the Company’s solution for permanent birth control, is based on the Company’s non-surgical platform technology and is presently completing a validation study under an approved Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA). FemaSeed™ (FemaSeed), a solution which enables directed intrauterine insemination to improve on traditional intrauterine insemination (IUI) and provide a lower cost option to in vitro fertilization methods, received approval in April 2021 from the FDA on its IDE and the clinical study was initiated in July 2021. FemVue® (FemVue), a solution that enables fallopian tube assessment with ultrasound as an alternative to the radiologic approach (hysterosalpingogram) for the diagnosis of infertility, is approved for sale in the U.S., Europe, Japan, and Canada. FemChec® (FemChec), allows for fallopian tube evaluation after a FemBloc procedure to confirm occlusion (or procedure success) and is part of the FemBloc validation study. FemCerv® (FemCerv) is a solution for complete tissue sampling with minimal contamination of the endocervical canal as an alternative to the single biopsy method, is approved for sale in the U.S. and Europe. FemCath™ (FemCath), allows for selective evaluation of an individual fallopian tube as an alternative to the traditional intrauterine catheter that is undirected, is approved for sale in the U.S. |
Basis of Presentation | Basis of Presentation The Company has prepared the accompanying financial statements pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (SEC). Certain information and footnote disclosures normally included in the annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) have been condensed or omitted pursuant to these rules and regulations. These financial statements should be read in conjunction with the Company’s audited financial statements and footnotes related thereto for the year ended December 31, 2021 included in our Annual Report on Form 10K filed with the SEC on March 24, 2022 (the Annual Report). In the opinion of management, the unaudited financial statements include all adjustments (consisting only of normal recurring adjustments) necessary to present fairly the Company’s financial position and the results of its operations and cash flows at the dates for periods presented. The results of operations for such interim periods are not necessarily indicative of the results to be expected for the full year. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expense during the reporting periods. The most significant estimates used in these financial statements include the valuation of stock options, warrants, useful lives of property and equipment, intangible assets, and the pre-IPO valuation of our common stock and preferred stock. Estimates for these and other items are subject to change and are reassessed by management in accordance with U.S. GAAP. Actual results could differ from those estimates. |
Liquidity | Liquidity As of March 31, 2022, the Company has cash and cash equivalents of $21,767,634. The Company plans to finance its operations and development needs with its existing cash and cash equivalents, additional equity and/or debt financing arrangements, and revenue from the sale of FemVue to support the Company’s research and development activities, largely in connection with FemBloc and FemaSeed. There can be no assurance that the Company will be able to obtain additional financing on terms acceptable to the Company, on a timely basis, or at all. If the Company is not able to obtain sufficient funds on acceptable terms when needed, the Company’s business, results of operations, and financial condition could be materially adversely impacted. For the three months ended March 31, 2022, the Company generated a net loss of $2,883,030. The Company expects such losses to increase over the next few years as the Company advances FemBloc and FemaSeed through clinical development until FDA approval is received and the products are available to be marketed. The Company believes that its cash and cash equivalents as of March 31, 2022 will be sufficient to fund our ongoing operations at least 12 months from the date of filing these financial statements. |
Recently Issued Accounting Pronouncements Adopted and Not Yet Adopted | Recently Issued Accounting Pronouncements – Recently Adopted On January 1, 2021, the Company adopted Accounting Standards Update (ASU) 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes Recently Issued Accounting Pronouncements – Not Yet Adopted In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses Measurement of Credit Losses on Financial Instruments No other new accounting pronouncement issued or effective has had, or is expected to have, a material impact on the Company’s financial statements. |
Inventories (Tables)
Inventories (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Inventories [Abstract] | |
Inventory Stated at Cost, Net of Reserve | Inventory stated at cost, net of reserve, consisted of the following: March 31, 2022 December 31, 2021 Materials $ 132,185 111,531 Work in progress 55,709 12,795 Finished goods 35,114 83,944 Inventory, net $ 223,008 208,270 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Accrued Expenses [Abstract] | |
Accrued Expenses | Accrued expenses consisted of the following: March 31, 2022 December 31, 2021 Clinical trial costs $ 324,329 301,730 Compensation costs 127,873 98,272 Franchise taxes 16,500 103,020 Other 96,526 100,765 Accrued expenses $ 565,228 603,787 |
Clinical Holdback (Tables)
Clinical Holdback (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Clinical Holdback [Abstract] | |
Clinical Holdback Liability | The following table shows the activity within the clinical holdback liability accounts for the three months ended March 31, 2022: Balance at December 31, 2021 $ 168,738 Clinical holdback retained 4,023 Clinical holdback paid (34,021 ) Balance at March 31 2022 $ 138,740 Less: clinical holdback - current portion (36,238 ) Clinical holdback - long-term portion $ 102,502 |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Revenue Recognition [Abstract] | |
Sales by Geographic Region | The following table summarizes our FemVue sales by geographic region as follows: Three Months Ended March 31, 2022 2021 Primary geographical markets U.S. $ 263,360 271,730 International 58,045 58,045 Total $ 321,405 329,775 |
Equity Incentive Plans (Tables)
Equity Incentive Plans (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Equity Incentive Plans [Abstract] | |
Stock Option Plan Activity | Activity under the stock option plans was as follows: Number of options Weighted average exercise price Weighted average remaining contracted term in years Aggregate intrinsic value Outstanding at December 31, 2021 689,995 $ 3.58 $ 683,531 Granted 270,170 6.71 Expired (3,334 ) 27.00 Forfeited (834 ) 6.12 Outstanding at March 31, 2022 955,997 $ 4.38 6.47 $ 125,279 Vested and exercisable at March 31, 2022 529,027 $ 3.65 5.21 $ 64,168 |
Estimated Using Assumptions | The weighted-average weighted-average Employee Nonemployee Expected term (in years) 6.47 6.00 Risk‑free interest rate 1.74 % 1.64 % Dividend yield — % — % Expected volatility 107.23 % 107.78 % The fair value of the inducement grant was $2.46 and was estimated using the following assumptions: Inducement Expected term (in years) 6.25 Risk‑free interest rate 1.76 % Dividend yield — % Expected volatility 106.76 % |
Share-based Compensation Expense | The following table shows the share-based compensation expense related to vested stock option grants to employees and nonemployees by financial statement line item on the accompanying statement of comprehensive loss: Three Months Ended March 31, 2022 2021 Research and development $ 29,139 35,496 Sales and marketing 1,126 926 General and administrative 14,094 36,068 Total share-based compensation expense $ 44,359 72,490 |
Net Loss per Share Attributab_2
Net Loss per Share Attributable to Common Stockholders (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Net Loss per Share Attributable to Common Stockholders [Abstract] | |
Computation of Basic and Diluted Net Loss Per Share | The following table sets forth the computation of the basic and diluted net loss per share: Three Months Ended March 31, 2022 2021 Net loss attributable to common stockholders, basic & diluted $ (2,883,030 ) (1,830,232 ) Weighted average number of shares used in computing net loss per share attributable to common stockholders, basic and diluted 11,804,165 995,208 Net loss per share attributable to common stockholders, basic and diluted $ (0.24 ) (1.84 ) |
Computations of Diluted Weighted Average Shares Outstanding | The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding because they would be anti-dilutive March 31, 2022 March 31, 2021 Convertible preferred stock outstanding — 8,116,343 Options to purchase common stock 1,055,997 740,444 Warrants to purchase to common stock 244,572 244,572 Total potential shares 1,300,569 9,101,359 |
Organization, Nature of Busin_3
Organization, Nature of Business, and Liquidity (Details) | 3 Months Ended | ||
Mar. 31, 2022USD ($)Segment | Mar. 31, 2021USD ($) | Dec. 31, 2021USD ($) | |
Organization and Nature of Business [Abstract] | |||
Number of operating segments | Segment | 1 | ||
Liquidity [Abstract] | |||
Cash and cash equivalents | $ 21,767,634 | $ 24,783,029 | |
Net loss | $ (2,883,030) | $ (1,830,232) |
Cash and Cash Equivalents (Deta
Cash and Cash Equivalents (Details) - USD ($) | Mar. 31, 2022 | Dec. 31, 2021 |
Level 1 [Member] | Money Market Funds [Member] | ||
Assets, Fair Value Disclosure [Abstract] | ||
Cash and cash equivalent | $ 21,424,306 | $ 24,388,443 |
Inventories (Details)
Inventories (Details) - USD ($) | Mar. 31, 2022 | Dec. 31, 2021 |
Inventories [Abstract] | ||
Materials | $ 132,185 | $ 111,531 |
Work in progress | 55,709 | 12,795 |
Finished goods | 35,114 | 83,944 |
Inventory, net | 223,008 | 208,270 |
Reserve for expired inventory | $ 1,287 | $ 850 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Mar. 31, 2022 | Dec. 31, 2021 |
Accrued Expenses [Abstract] | ||
Clinical trail costs | $ 324,329 | $ 301,730 |
Compensation costs | 127,873 | 98,272 |
Franchise taxes | 16,500 | 103,020 |
Other | 96,526 | 100,765 |
Accrued expenses | $ 565,228 | $ 603,787 |
Clinical Holdback (Details)
Clinical Holdback (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Dec. 31, 2021 | |
Clinical Holdback Liability [Roll Forward] | ||
Balance | $ 168,738 | |
Clinical holdback retained | 4,023 | |
Clinical holdback paid | (34,021) | |
Balance | 138,740 | |
Less: clinical holdback - current portion | (36,238) | $ (18,947) |
Clinical holdback - long-term portion | $ 102,502 | $ 149,791 |
Revenue Recognition (Details)
Revenue Recognition (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Revenue Recognition [Abstract] | ||
Revenue recognized from performance obligations in prior periods | $ 0 | $ 0 |
Percentage of restocking fee | 30.00% | |
Primary Geographical Markets [Abstract] | ||
Sales | $ 321,405 | 329,775 |
FemVue [Member] | ||
Primary Geographical Markets [Abstract] | ||
Sales | 321,405 | 329,775 |
FemVue [Member] | U.S. [Member] | ||
Primary Geographical Markets [Abstract] | ||
Sales | 263,360 | 271,730 |
FemVue [Member] | International [Member] | ||
Primary Geographical Markets [Abstract] | ||
Sales | $ 58,045 | $ 58,045 |
Minimum [Member] | ||
Revenue Recognition [Abstract] | ||
Revenue recognition payment period term | 30 days | |
Maximum [Member] | ||
Revenue Recognition [Abstract] | ||
Revenue recognition payment period term | 60 days |
Notes Payable (Details)
Notes Payable (Details) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2022 | Dec. 31, 2021 | |
Notes Payable [Abstract] | ||
Note payable - current portion | $ 45,666 | $ 181,123 |
Promissory Notes [Member] | AFCO Credit Corporation [Member] | ||
Notes Payable [Abstract] | ||
Note payable - current portion | 45,666 | 181,123 |
Interest expense on loan | $ 1,796 | $ 378 |
Redeemable Convertible Prefer_2
Redeemable Convertible Preferred Stock and Stockholders' Equity (Details) - USD ($) | 1 Months Ended | 3 Months Ended | |
Jun. 30, 2021 | Mar. 31, 2022 | Dec. 31, 2021 | |
Stockholders Equity [Abstract] | |||
Common stock, outstanding (in shares) | 11,804,165 | 11,804,165 | |
Dividends declared or paid | $ 0 | ||
IPO [Member] | |||
Stockholders Equity [Abstract] | |||
Shares issued and sold (in shares) | 2,650,000 | ||
Share price (in dollars per share) | $ 13 | ||
Proceeds from issuance after deducting underwriting discounts, commissions, and legal expenses | $ 31,613,500 | ||
Deferred offering costs | 2,016,143 | ||
Legal expenses incurred paid by underwriters | $ 425,000 | ||
Automatic conversion of preferred stock (in shares) | 8,116,343 | ||
Common Stock [Member] | |||
Stockholders Equity [Abstract] | |||
Number of shares authorized, for all classes of stock (in shares) | 200,000,000 | ||
Preferred Stock [Member] | |||
Stockholders Equity [Abstract] | |||
Number of shares authorized, for all classes of stock (in shares) | 10,000,000 |
Equity Incentive Plans, Stock O
Equity Incentive Plans, Stock Option Plans (Details) - shares | 1 Months Ended | |
Jun. 30, 2021 | Mar. 31, 2022 | |
2015 Plan [Member] | ||
Stock Option Plan [Abstract] | ||
New grants awarded (in shares) | 0 | |
2021 Plan [Member] | ||
Stock Option Plan [Abstract] | ||
Common stock reserved for issuance (in shares) | 1,319,136 |
Equity Incentive Plans, Stock_2
Equity Incentive Plans, Stock Option Plan, Activity (Details) - 2021 Employee Stock Purchase Plan [Member] - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Dec. 31, 2021 | |
Number of Options [Roll Forward] | ||
Beginning balance (in shares) | 689,995 | |
Granted (in shares) | 270,170 | |
Expired (in shares) | (3,334) | |
Forfeited (in shares) | (834) | |
Ending balance (in shares) | 955,997 | |
Weighted Average Exercise Price [Abstract] | ||
Beginning balance (in dollars per share) | $ 3.58 | |
Granted (in dollars per share) | 6.71 | |
Expired (in dollars per share) | 27 | |
Forfeited (in dollars per share) | 6.12 | |
Ending balance (in dollars per share) | $ 4.38 | |
Option outstanding [Abstract] | ||
Weighted average remaining contracted term in years | 6 years 5 months 19 days | |
Aggregate intrinsic value | $ 125,279 | $ 683,531 |
Options vested and exercisable [Abstract] | ||
Options vested and exercisable, Number of option vested (in shares) | 529,027 | |
Options vested and exercisable, Exercise price (in dollars per share) | $ 3.65 | |
Options vested and exercisable, Weighted average remaining life years | 5 years 2 months 15 days | |
Option vested, Aggregate intrinsic value | $ 64,168 | |
Estimated Fair Value Assumptions [Abstract] | ||
Exercised (in shares) | 0 | |
Employee [Member] | ||
Number of Options [Roll Forward] | ||
Granted (in shares) | 253,170 | |
Weighted Average Exercise Price [Abstract] | ||
Ending balance (in dollars per share) | $ 6.96 | |
Options vested and exercisable [Abstract] | ||
Fair values of options granted (in dollars per share) | $ 2.34 | |
Estimated Fair Value Assumptions [Abstract] | ||
Expected term (in years) | 6 years 5 months 19 days | |
Risk free interest rate | 1.74% | |
Dividend yield | 0.00% | |
Expected volatility | 107.23% | |
Employee [Member] | Performance Based Options [Member] | ||
Number of Options [Roll Forward] | ||
Granted (in shares) | 140,000 | |
Nonemployee [Member] | ||
Number of Options [Roll Forward] | ||
Granted (in shares) | 17,000 | |
Weighted Average Exercise Price [Abstract] | ||
Ending balance (in dollars per share) | $ 3.03 | |
Options vested and exercisable [Abstract] | ||
Fair values of options granted (in dollars per share) | $ 2.49 | |
Estimated Fair Value Assumptions [Abstract] | ||
Expected term (in years) | 6 years | |
Risk free interest rate | 1.64% | |
Dividend yield | 0.00% | |
Expected volatility | 107.78% |
Equity Incentive Plans, Inducem
Equity Incentive Plans, Inducement Grant and Valuation (Details) - Inducement Grant [Member] - $ / shares | Feb. 28, 2022 | Mar. 31, 2022 |
Inducement Grant [Abstract] | ||
Granted (in shares) | 100,000 | |
Exercise price (in dollars per share) | $ 2.97 | |
Vesting period | 4 years | |
Fair values of options granted (in dollars per share) | $ 2.46 | |
Estimated Fair Value Assumptions [Abstract] | ||
Expected term (in years) | 6 years 3 months | |
Risk free interest rate | 1.76% | |
Dividend yield | 0.00% | |
Expected volatility | 106.76% | |
Shares outstanding (in shares) | 100,000 | |
Option exercisable (in shares) | 0 |
Equity Incentive Plans, Share-B
Equity Incentive Plans, Share-Based Compensation Expense (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Stock-based Compensation Expense [Abstract] | ||
Stock based compensation expense | $ 44,359 | $ 72,490 |
Stock based compensation expense expected to be recognized for employees and nonemployees | 1,122,943 | |
Compensation expense to be recognized upon achieving certain performance condition | 463,311 | |
Unrecognized expenses | $ 659,632 | |
Weighted-average period over which unrecognized compensation is expected to be recognized | 3 years 4 months 24 days | |
Research and Development [Member] | ||
Stock-based Compensation Expense [Abstract] | ||
Stock based compensation expense | $ 29,139 | 35,496 |
Sales and Marketing [Member] | ||
Stock-based Compensation Expense [Abstract] | ||
Stock based compensation expense | 1,126 | 926 |
General and Administrative [Member] | ||
Stock-based Compensation Expense [Abstract] | ||
Stock based compensation expense | $ 14,094 | $ 36,068 |
Equity Incentive Plans, Employe
Equity Incentive Plans, Employee Stock Purchase Plan (Details) - 2021 Employee Stock Purchase Plan [Member] | Mar. 31, 2022shares |
Employee Stock Purchase Plan [Abstract] | |
Common stock reserved for issuance (in shares) | 284,707 |
Common stock purchased (in shares) | 0 |
Net Loss per Share Attributab_3
Net Loss per Share Attributable to Common Stockholders (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Net Loss per Share Attributable to Common Stockholders [Abstract] | ||
Net loss attributable to common stockholders, basic | $ (2,883,030) | $ (1,830,232) |
Net loss attributable to common stockholders, diluted | $ (2,883,030) | $ (1,830,232) |
Weighted average number of shares used in computing net loss per share attributable to common stockholders, basic (in shares) | 11,804,165 | 995,208 |
Weighted average number of shares used in computing net loss per share attributable to common stockholders, diluted (in shares) | 11,804,165 | 995,208 |
Net loss per share attributable to common stockholders, basic (In dollars per share) | $ (0.24) | $ (1.84) |
Net loss per share attributable to common stockholders, diluted (in dollars per share) | $ (0.24) | $ (1.84) |
Weighted Average Number of Shares Outstanding [Abstract] | ||
Convertible preferred stock outstanding (in shares) | 0 | 8,116,343 |
Options to purchase common stock (in shares) | 1,055,997 | 740,444 |
Warrants to purchase to common stock (in shares) | 244,572 | 244,572 |
Total potential shares (in shares) | 1,300,569 | 9,101,359 |