Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2023 | May 09, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2023 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
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 | |
Entity Address, Address Line Two | 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, $0.001 par value | |
Trading Symbol | FEMY | |
Security Exchange Name | NASDAQ | |
Entity Common Stock, Shares Outstanding | 13,190,573 |
Balance Sheets
Balance Sheets - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 10,161,338 | $ 12,961,936 |
Accounts receivable, net | 123,955 | 77,470 |
Inventory, net | 500,741 | 436,723 |
Other current assets | 542,067 | 655,362 |
Total current assets | 11,328,101 | 14,131,491 |
Property and equipment, at cost: | ||
Leasehold improvements | 1,195,637 | 1,195,637 |
Office equipment | 99,344 | 99,344 |
Furniture and fixtures | 419,303 | 419,303 |
Machinery and equipment | 2,601,389 | 2,572,243 |
Construction in progress | 406,588 | 413,843 |
Property and equipment, gross | 4,722,261 | 4,700,370 |
Less accumulated depreciation | (3,344,400) | (3,217,319) |
Net property and equipment | 1,377,861 | 1,483,051 |
Long-term assets: | ||
Lease right-of-use assets, net | 239,351 | 319,557 |
Intangible assets, net of accumulated amortization | 1,881 | 3,294 |
Other long-term assets | 920,812 | 958,177 |
Total long-term assets | 1,162,044 | 1,281,028 |
Total assets | 13,868,006 | 16,895,570 |
Current liabilities: | ||
Accounts payable | 526,764 | 510,758 |
Accrued expenses | 535,417 | 456,714 |
Note payable | 0 | 141,298 |
Clinical holdback - current portion | 45,352 | 45,206 |
Lease liabilities - current portion | 305,071 | 373,833 |
Total current liabilities | 1,412,604 | 1,527,809 |
Long-term liabilities: | ||
Clinical holdback - long-term portion | 98,818 | 96,658 |
Lease liabilities - long-term portion | 0 | 28,584 |
Total long-term liabilities | 98,818 | 125,242 |
Total liabilities | 1,511,422 | 1,653,051 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Common stock, $.001 par, 200,000,000 authorized, 11,989,796 shares issued and 11,872,573 outstanding as of March 31, 2023; and 11,986,927 shares issued and 11,869,704 outstanding as of December 31, 2022 | 11,990 | 11,987 |
Treasury stock, 117,223 shares | (60,000) | (60,000) |
Warrants | 567,972 | 567,972 |
Additional paid-in-capital | 108,917,384 | 108,857,065 |
Accumulated deficit | (97,080,762) | (94,134,505) |
Total stockholders' equity | 12,356,584 | 15,242,519 |
Total liabilities and stockholders' equity | $ 13,868,006 | $ 16,895,570 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
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) | 11,989,796 | 11,986,927 |
Common stock, outstanding (in shares) | 11,872,573 | 11,869,704 |
Treasury stock, shares (in shares) | 117,223 | 117,223 |
Statements of Comprehensive Los
Statements of Comprehensive Loss - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Statements of Comprehensive Loss [Abstract] | ||
Sales | $ 293,984 | $ 321,405 |
Cost of sales | 105,120 | 122,675 |
Gross margin | 188,864 | 198,730 |
Operating expenses: | ||
Research and development | 1,537,439 | 1,421,063 |
Sales and marketing | 244,896 | 68,863 |
General and administrative | 1,315,137 | 1,447,355 |
Depreciation and amortization | 133,066 | 144,199 |
Total operating expenses | 3,230,538 | 3,081,480 |
Loss from operations | (3,041,674) | (2,882,750) |
Other income (expense): | ||
Interest income | 97,089 | 2,454 |
Interest expense | (1,672) | (2,734) |
Other income (expense), net | 95,417 | (280) |
Net loss | (2,946,257) | (2,883,030) |
Net loss attributable to common stockholders, basic | (2,946,257) | (2,883,030) |
Net loss attributable to common stockholders, diluted | $ (2,946,257) | $ (2,883,030) |
Net loss per share attributable to common stockholders, basic (in dollars per share) | $ (0.25) | $ (0.24) |
Net loss per share attributable to common stockholders, diluted (in dollars per share) | $ (0.25) | $ (0.24) |
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic (in shares) | 11,872,255 | 11,804,165 |
Weighted-average shares used in computing net loss per share attributable to common stockholders, diluted (in shares) | 11,872,255 | 11,804,165 |
Statements of Stockholders' Equ
Statements of Stockholders' Equity - USD ($) | Common Stock [Member] | Treasury Stock [Member] | Warrants [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2021 | $ 11,921 | $ (60,000) | $ 702,492 | $ 108,418,304 | $ (82,740,335) | $ 26,332,382 |
Balance (in shares) at Dec. 31, 2021 | 11,921,388 | 117,223 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Share-based compensation expense | $ 0 | $ 0 | 0 | 44,359 | 0 | 44,359 |
Net loss | 0 | 0 | 0 | 0 | (2,883,030) | (2,883,030) |
Balance at Mar. 31, 2022 | $ 11,921 | $ (60,000) | 702,492 | 108,462,663 | (85,623,365) | 23,493,711 |
Balance (in shares) at Mar. 31, 2022 | 11,921,388 | 117,223 | ||||
Balance at Dec. 31, 2022 | $ 11,987 | $ (60,000) | 567,972 | 108,857,065 | (94,134,505) | 15,242,519 |
Balance (in shares) at Dec. 31, 2022 | 11,986,927 | 117,223 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock in connection with At-The-Market offering, net of issuance costs | $ 3 | $ 0 | 0 | 3,365 | 0 | 3,368 |
Issuance of common stock in connection with At-The-Market offering, net of issuance costs (in shares) | 2,869 | 0 | ||||
Share-based compensation expense | $ 0 | $ 0 | 0 | 56,954 | 0 | 56,954 |
Net loss | 0 | 0 | 0 | 0 | (2,946,257) | (2,946,257) |
Balance at Mar. 31, 2023 | $ 11,990 | $ (60,000) | $ 567,972 | $ 108,917,384 | $ (97,080,762) | $ 12,356,584 |
Balance (in shares) at Mar. 31, 2023 | 11,989,796 | 117,223 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (2,946,257) | $ (2,883,030) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 131,653 | 136,769 |
Amortization | 1,413 | 7,430 |
Amortization of right-of-use assets | 75,635 | 86,233 |
Inventory reserve | 300 | 2,700 |
Share-based compensation expense | 56,954 | 44,359 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (46,485) | (86,044) |
Inventory | (64,318) | (17,438) |
Other assets | 150,654 | 18,553 |
Accounts payable | 3,016 | 102,855 |
Accrued expenses | 78,703 | (38,559) |
Lease liabilities | (91,211) | (97,851) |
Other liabilities | 2,306 | (29,998) |
Net cash used in operating activities | (2,647,637) | (2,754,021) |
Cash flows from investing activities: | ||
Purchases of furniture and equipment | (8,901) | (120,368) |
Net cash used in investing activities | (8,901) | (120,368) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock | 3,373 | 0 |
Repayment of notes payable | (141,298) | (135,457) |
Payments under lease obligations | (6,135) | (5,549) |
Net cash used in financing activities | (144,060) | (141,006) |
Net change in cash and cash equivalents | (2,800,598) | (3,015,395) |
Cash and cash equivalents: | ||
Beginning of period | 12,961,936 | 24,783,029 |
End of period | 10,161,338 | 21,767,634 |
Cash paid for: | ||
Interest | 1,672 | 2,734 |
Income taxes | 0 | 800 |
Non-cash investing and financing activities: | ||
Property and equipment costs included in accounts payable | 12,990 | 0 |
Commissions and deferred offering costs relating to proceeds from issuance of common stock | 109 | 0 |
Prepaid insurance financed with promissory notes | $ 0 | $ 45,666 |
Organization, Nature of Busines
Organization, Nature of Business, and Liquidity | 3 Months Ended |
Mar. 31, 2023 | |
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. The Company’s mission is to provide women 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 with an initial focus on servicing the reproductive health needs for those seeking permanent birth control or solutions for infertility issues. Femasys 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 we recently completed a validation study under an approved Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) and plan to use the study data to support which of the two confirmation tests (ultrasound or radiology) should be studied in a new pivotal trial to support a potential future application for PMA for FemBloc. Results of the small study along with the trial design for the pivotal clinical trial was submitted to the FDA in the first quarter of 2023. FemaSeed® (FemaSeed), a solution which enables directed intrauterine insemination to improve on traditional intrauterine insemination (IUI) and provides 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. An updated study design received approval in October 2022 from the FDA. FemaSeed is approved for sale in Canada. 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., Japan, and Canada. FemChec® (FemChec), allows for fallopian tube evaluation after a FemBloc procedure to confirm occlusion (or procedure success). FemCerv® (FemCerv) is a solution for complete tissue sampling with minimal contamination of the endocervical canal as an alternative to the single biopsy method, and is approved for sale in the U.S. 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, 2022 included in our Annual Report on Form 10K filed with the SEC on March 30, 2023 (the Annual Report). ,There have been no material changes to the Company’s significant accounting policies described in Note 2 to the financial statements included in 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 and intangible assets.. 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, 2023, the Company had cash and cash equivalents of $10,161,338. 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 primarily 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, 2023, the Company generated a net loss of $2,946,257. 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 financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred net operating losses in every year since inception and has an accumulated deficit as of March 31, 2023 of $97,080,762 and expects to incur additional losses and negative operating cash flows for at least the next twelve months. The Company’s ability to meet its obligations is dependent upon its ability to generate sufficient cash flows from operations and future financing transactions (see Note 12). Although management expects the Company will continue as a going concern, there is no assurance that management’s plans will be successful since the availability and amount of such funding is not certain. Accordingly, substantial doubt exists about the Company’s ability to continue as a going concern for at least one year from the issuance of these financial statements. The accompanying financial statements do not include any adjustments to reflect the possible future effects on the recoverability of assets or the amounts and classifications of liabilities that may result from the possible inability of the Company to continue as a going concern. Recently Issued Accounting Pronouncements – Recently Adopted On January 1, 2023, the Company adopted Accounting Standards Update (ASU) 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which the Financial Accounting Standards Board (FASB) issued in June 2016. The new standard changes the accounting for credit losses for financial assets and certain other instruments, including trade receivables and contract assets, that are not measured at fair value through net income. Under legacy standards, we recognize an impairment of receivables when it was probable that a loss had been incurred. Under the new standard, we are required to recognize estimated credit losses expected to occur over the estimated life or remaining contractual life of an asset (which includes losses that may be incurred in future periods) using a broader range of information including reasonable and supportable forecasts about future economic conditions. The guidance is effective for smaller reporting companies as defined by the SEC for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years with early adoption permitted. The Company’s adoption of this new guidance did not have a material impact on the Company’s financial statements and footnote disclosures (unaudited). Recently Issued Accounting Pronouncements – Not Yet Adopted 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, 2023 | |
Cash and Cash Equivalents [Abstract] | |
Cash and Cash Equivalents | (2) Cash and Cash Equivalents As of March 31, 2023 and December 31, 2022, money market funds included in cash and cash equivalents on the balance sheets were $60,805 and $12,553,557, 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, 2023 | |
Inventories [Abstract] | |
Inventories | (3) Inventories Inventory stated at cost, net of reserve, consisted of the following: March 31, December 31, 2023 2022 Materials $ 283,655 244,498 Work in progress 98,775 100,453 Finished goods 118,311 91,772 Inventory, net $ 500,741 436,723 The FemVue reserve for slow moving, obsolete, or unusable inventories was as of March 31, 2023 and December 31, 2022, respectively. |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2023 | |
Accrued Expenses [Abstract] | |
Accrued Expenses | (4) Accrued Expenses Accrued expenses consisted of the following: March 31, December 31, 2023 2022 Clinical trial costs $ 315,428 333,440 Compensation costs 111,457 85,191 Franchise taxes 7,100 26,886 Other 101,432 11,197 Accrued expenses $ 535,417 456,714 |
Clinical Holdback
Clinical Holdback | 3 Months Ended |
Mar. 31, 2023 | |
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, 2023: Balance at December 31, 2022 $ 141,864 Clinical holdback retained 2,634 Clinical holdback paid (328 ) Balance at March 31 2023 $ 144,170 Less: clinical holdback - current portion (45,352 ) Clinical holdback - long-term portion $ 98,818 |
Revenue Recognition
Revenue Recognition | 3 Months Ended |
Mar. 31, 2023 | |
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, 2023 and 2022, 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, 2023 or 2022. 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 sales, primarily from FemVue, by geographic region as follows: Three Months Ended March 31, Primary geographical markets 2023 2022 U.S. $ 293,984 263,360 International — 58,045 Total $ 293,984 321,405 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2023 | |
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, 2023 and December 31, 2022. |
Notes Payable
Notes Payable | 3 Months Ended |
Mar. 31, 2023 | |
Notes Payable [Abstract] | |
Notes Payable | (8) Notes Payable AFCO Credit Corporation (AFCO) As of March 31, 2023 and December 31, 2022, the principal balance on the remaining AFCO promissory note was $0 and $141,298, respectively and is included in Notes payable in the accompanying balance sheets. Interest expense in connection with the AFCO promissory notes was $1,319 and $1,796 for the three months ended March 31, 2023 and 2022, respectively . |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2023 | |
Stockholders' Equity [Abstract] | |
Stockholders' Equity | (9) Stockholders’ Equity In July 2022, the Company entered into an Equity Distribution Agreement (the “Equity Distribution Agreement”) with Piper Sandler & Co. (“Piper Sandler” or the “Sales Agent”) and filed a related Prospectus establishing an “at-the-market” facility, pursuant to which the Company may offer and sell shares of common stock having an aggregate offering price of up to $8,800,000 from time to time through the Sales Agent pursuant to the Prospectus. For the three months ended March 31, 2023, 2,869 shares of common stock were sold under the Equity Distribution Agreement. As of March 31, 2023, the Company had 11,872,573 shares of common stock outstanding, and no dividends have been declared or paid. |
Equity Incentive Plans
Equity Incentive Plans | 3 Months Ended |
Mar. 31, 2023 | |
Equity Incentive Plans [Abstract] | |
Equity Incentive Plans | (10) Equity Incentive Plans Stock-Based Awards (a) Stock Option Plans Activity under the Company’s stock option plans for the three months ended March 31, 2023 was as follows: Number of Weighted Average Options Exercise Price Outstanding at December 31, 2022 931,550 $ 3.97 Granted 5,000 1.18 Forfeited (50,055 ) 1.87 Outstanding at March 31, 2023 886,495 $ 4.07 Vested and exercisable at March 479,296 $ 3.30 The 5,000 options granted under our 2021 Stock Option Plan for the three months ended March Fair Value of Awards $ 0.62 Grant Price $ 1.18 Expected term (in years) 2.00 Risk‑free interest rate 4.39 % Dividend yield — % Expected volatility 95.48 % No options were exercised for the three months ended March 31, 2023 under our stock option plans. As of March 31, 2023, the total number of shares of common stock reserved for future awards under the 2021 Stock Option Plan was 1,754,980. (b) Inducement Grants For the three months ended March 31, 2023, no inducement awards were granted. As of March 31, 2023, 150,000 shares were outstanding with a weighted average exercise price of $2.42, and 25,000 shares were vested and exercisable with a weighted average exercise price of $2.97. (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 2023 2022 Research and development $ 25,059 29,139 Sales and marketing (2,544 ) 1,126 General and administrative 34,439 14,094 Total share-based compensation expense $ 56,954 44,359 As March (d) Employee Stock Purchase Plan (ESPP) For the three months ended March 31, 2023, no shares have been issued under the Company’s ESPP Plan. As of March 31, 2023, the total number of shares of common stock reserved for future awards under the ESPP Plan was 398,561. |
Net Loss per Share Attributable
Net Loss per Share Attributable to Common Stockholders | 3 Months Ended |
Mar. 31, 2023 | |
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, 2023 2022 Net loss attributable to common stockholders, basic & diluted $ (2,946,257 ) (2,883,030 ) Weighted average number of shares used in computing net loss per share attributable to common stockholders, basic and diluted 11,872,255 11,804,165 Net loss per share attributable to common stockholders, basic and diluted $ (0.25 ) (0.24 ) 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, 2023 March 31, 2022 Options to purchase common stock 1,036,495 1,055,997 Warrants to purchase to common stock 233,460 244,572 Total potential shares 1,269,955 1,300,569 |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | (12) Subsequent Events Effective April 18, 2023, the Company suspended its “at-the-market” facility with the Sales Agent pursuant to that certain prospectus supplement dated July 12, 2022 and Equity Distribution Agreement, dated July 1, 2022 and terminated the continuous offering under such prospectus. The Company will not make any sales of its Common Stock pursuant to the Equity Distribution Agreement unless and until a new prospectus supplement is filed with the Securities and Exchange Commission; however, the Equity Distribution Agreement remains in full force and effect. |
Organization, Nature of Busin_2
Organization, Nature of Business, and Liquidity (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
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. The Company’s mission is to provide women 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 with an initial focus on servicing the reproductive health needs for those seeking permanent birth control or solutions for infertility issues. Femasys 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 we recently completed a validation study under an approved Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) and plan to use the study data to support which of the two confirmation tests (ultrasound or radiology) should be studied in a new pivotal trial to support a potential future application for PMA for FemBloc. Results of the small study along with the trial design for the pivotal clinical trial was submitted to the FDA in the first quarter of 2023. FemaSeed® (FemaSeed), a solution which enables directed intrauterine insemination to improve on traditional intrauterine insemination (IUI) and provides 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. An updated study design received approval in October 2022 from the FDA. FemaSeed is approved for sale in Canada. 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., Japan, and Canada. FemChec® (FemChec), allows for fallopian tube evaluation after a FemBloc procedure to confirm occlusion (or procedure success). FemCerv® (FemCerv) is a solution for complete tissue sampling with minimal contamination of the endocervical canal as an alternative to the single biopsy method, and is approved for sale in the U.S. 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, 2022 included in our Annual Report on Form 10K filed with the SEC on March 30, 2023 (the Annual Report). ,There have been no material changes to the Company’s significant accounting policies described in Note 2 to the financial statements included in 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 and intangible assets.. 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, 2023, the Company had cash and cash equivalents of $10,161,338. 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 primarily 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, 2023, the Company generated a net loss of $2,946,257. 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 financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred net operating losses in every year since inception and has an accumulated deficit as of March 31, 2023 of $97,080,762 and expects to incur additional losses and negative operating cash flows for at least the next twelve months. The Company’s ability to meet its obligations is dependent upon its ability to generate sufficient cash flows from operations and future financing transactions (see Note 12). Although management expects the Company will continue as a going concern, there is no assurance that management’s plans will be successful since the availability and amount of such funding is not certain. Accordingly, substantial doubt exists about the Company’s ability to continue as a going concern for at least one year from the issuance of these financial statements. The accompanying financial statements do not include any adjustments to reflect the possible future effects on the recoverability of assets or the amounts and classifications of liabilities that may result from the possible inability of the Company to continue as a going concern. |
Recently Issued Accounting Pronouncements Adopted and Not Yet Adopted | Recently Issued Accounting Pronouncements – Recently Adopted On January 1, 2023, the Company adopted Accounting Standards Update (ASU) 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which the Financial Accounting Standards Board (FASB) issued in June 2016. The new standard changes the accounting for credit losses for financial assets and certain other instruments, including trade receivables and contract assets, that are not measured at fair value through net income. Under legacy standards, we recognize an impairment of receivables when it was probable that a loss had been incurred. Under the new standard, we are required to recognize estimated credit losses expected to occur over the estimated life or remaining contractual life of an asset (which includes losses that may be incurred in future periods) using a broader range of information including reasonable and supportable forecasts about future economic conditions. The guidance is effective for smaller reporting companies as defined by the SEC for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years with early adoption permitted. The Company’s adoption of this new guidance did not have a material impact on the Company’s financial statements and footnote disclosures (unaudited). Recently Issued Accounting Pronouncements – Not Yet Adopted 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, 2023 | |
Inventories [Abstract] | |
Inventory Stated at Cost, Net of Reserve | Inventory stated at cost, net of reserve, consisted of the following: March 31, December 31, 2023 2022 Materials $ 283,655 244,498 Work in progress 98,775 100,453 Finished goods 118,311 91,772 Inventory, net $ 500,741 436,723 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Accrued Expenses [Abstract] | |
Accrued Expenses | Accrued expenses consisted of the following: March 31, December 31, 2023 2022 Clinical trial costs $ 315,428 333,440 Compensation costs 111,457 85,191 Franchise taxes 7,100 26,886 Other 101,432 11,197 Accrued expenses $ 535,417 456,714 |
Clinical Holdback (Tables)
Clinical Holdback (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
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, 2023: Balance at December 31, 2022 $ 141,864 Clinical holdback retained 2,634 Clinical holdback paid (328 ) Balance at March 31 2023 $ 144,170 Less: clinical holdback - current portion (45,352 ) Clinical holdback - long-term portion $ 98,818 |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Revenue Recognition [Abstract] | |
Sales by Geographic Region | The following table summarizes our sales, primarily from FemVue, by geographic region as follows: Three Months Ended March 31, Primary geographical markets 2023 2022 U.S. $ 293,984 263,360 International — 58,045 Total $ 293,984 321,405 |
Equity Incentive Plans (Tables)
Equity Incentive Plans (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Equity Incentive Plans [Abstract] | |
Stock Option Plan Activity | Activity under the Company’s stock option plans for the three months ended March 31, 2023 was as follows: Number of Weighted Average Options Exercise Price Outstanding at December 31, 2022 931,550 $ 3.97 Granted 5,000 1.18 Forfeited (50,055 ) 1.87 Outstanding at March 31, 2023 886,495 $ 4.07 Vested and exercisable at March 479,296 $ 3.30 |
Estimated Using Assumptions | The 5,000 options granted under our 2021 Stock Option Plan for the three months ended March Fair Value of Awards $ 0.62 Grant Price $ 1.18 Expected term (in years) 2.00 Risk‑free interest rate 4.39 % Dividend yield — % Expected volatility 95.48 % |
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 2023 2022 Research and development $ 25,059 29,139 Sales and marketing (2,544 ) 1,126 General and administrative 34,439 14,094 Total share-based compensation expense $ 56,954 44,359 |
Net Loss per Share Attributab_2
Net Loss per Share Attributable to Common Stockholders (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
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, 2023 2022 Net loss attributable to common stockholders, basic & diluted $ (2,946,257 ) (2,883,030 ) Weighted average number of shares used in computing net loss per share attributable to common stockholders, basic and diluted 11,872,255 11,804,165 Net loss per share attributable to common stockholders, basic and diluted $ (0.25 ) (0.24 ) |
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, 2023 March 31, 2022 Options to purchase common stock 1,036,495 1,055,997 Warrants to purchase to common stock 233,460 244,572 Total potential shares 1,269,955 1,300,569 |
Organization, Nature of Busin_3
Organization, Nature of Business, and Liquidity (Details) | 3 Months Ended | ||
Mar. 31, 2023 USD ($) Segment | Mar. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Organization and Nature of Business [Abstract] | |||
Number of operating segments | Segment | 1 | ||
Liquidity [Abstract] | |||
Cash and cash equivalents | $ 10,161,338 | $ 12,961,936 | |
Net loss | (2,946,257) | $ (2,883,030) | |
Accumulated deficit | $ (97,080,762) | $ (94,134,505) |
Cash and Cash Equivalents (Deta
Cash and Cash Equivalents (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Level 1 [Member] | Money Market Funds [Member] | ||
Assets, Fair Value Disclosure [Abstract] | ||
Cash and cash equivalent | $ 60,805 | $ 12,553,557 |
Inventories (Details)
Inventories (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Inventories [Abstract] | ||
Materials | $ 283,655 | $ 244,498 |
Work in progress | 98,775 | 100,453 |
Finished goods | 118,311 | 91,772 |
Inventory, net | 500,741 | 436,723 |
Reserve for expired inventory | $ 2,380 | $ 2,103 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Accrued Expenses [Abstract] | ||
Clinical trail costs | $ 315,428 | $ 333,440 |
Compensation costs | 111,457 | 85,191 |
Franchise taxes | 7,100 | 26,886 |
Other | 101,432 | 11,197 |
Accrued expenses | $ 535,417 | $ 456,714 |
Clinical Holdback (Details)
Clinical Holdback (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Dec. 31, 2022 | |
Clinical Holdback Liability [Roll Forward] | ||
Balance | $ 141,864 | |
Clinical holdback retained | 2,634 | |
Clinical holdback paid | (328) | |
Balance | 144,170 | |
Less: clinical holdback - current portion | (45,352) | $ (45,206) |
Clinical holdback - long-term portion | $ 98,818 | $ 96,658 |
Revenue Recognition (Details)
Revenue Recognition (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Revenue Recognition [Abstract] | ||
Revenue recognized from performance obligations in prior periods | $ 0 | $ 0 |
Percentage of restocking fee | 30% | |
Primary Geographical Markets [Abstract] | ||
Sales | $ 293,984 | 321,405 |
FemVue [Member] | ||
Primary Geographical Markets [Abstract] | ||
Sales | 293,984 | 321,405 |
FemVue [Member] | U.S. [Member] | ||
Primary Geographical Markets [Abstract] | ||
Sales | 293,984 | 263,360 |
FemVue [Member] | International [Member] | ||
Primary Geographical Markets [Abstract] | ||
Sales | $ 0 | $ 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 | ||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Notes Payable [Abstract] | |||
Note payable | $ 0 | $ 141,298 | |
Promissory Notes [Member] | AFCO Credit Corporation [Member] | |||
Notes Payable [Abstract] | |||
Note payable | 0 | $ 141,298 | |
Interest expense on loan | $ 1,319 | $ 1,796 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2023 | Dec. 31, 2022 | Jul. 12, 2022 | |
Stockholders Equity [Abstract] | |||
Common stock, outstanding (in shares) | 11,872,573 | 11,869,704 | |
Dividends declared or paid | $ 0 | ||
Common Stock [Member] | |||
Stockholders Equity [Abstract] | |||
Authorized offering amount of securities | $ 8,800,000 | ||
Common stock sold (in shares) | 2,869 |
Equity Incentive Plans, Stock O
Equity Incentive Plans, Stock Option Plan, Activity (Details) - 2021 Stock Option Plan [Member] | 3 Months Ended |
Mar. 31, 2023 $ / shares shares | |
Number of Options [Roll Forward] | |
Beginning balance (in shares) | shares | 931,550 |
Granted (in shares) | shares | 5,000 |
Forfeited (in shares) | shares | (50,055) |
Ending balance (in shares) | shares | 886,495 |
Weighted Average Exercise Price [Abstract] | |
Beginning balance (in dollars per share) | $ 3.97 |
Granted (in dollars per share) | 1.18 |
Forfeited (in dollars per share) | 1.87 |
Ending balance (in dollars per share) | $ 4.07 |
Options vested and exercisable [Abstract] | |
Options vested and exercisable, Number of option vested (in shares) | shares | 479,296 |
Options vested and exercisable, Exercise price (in dollars per share) | $ 3.3 |
Options exercised (shares) | shares | 0 |
Common stock reserved for issuance (in shares) | shares | 1,754,980 |
Estimated Fair Value Assumptions [Abstract] | |
Grant Price (in dollars per share) | $ 1.18 |
Nonemployee [Member] | |
Weighted Average Exercise Price [Abstract] | |
Granted (in dollars per share) | 1.18 |
Estimated Fair Value Assumptions [Abstract] | |
Fair Value of Awards (in dollars per share) | 0.62 |
Grant Price (in dollars per share) | $ 1.18 |
Expected term (in years) | 2 years |
Risk free interest rate | 4.39% |
Dividend yield | 0% |
Expected volatility | 95.48% |
Equity Incentive Plans, Inducem
Equity Incentive Plans, Inducement Grant (Details) - Inducement Grant [Member] | 3 Months Ended |
Mar. 31, 2023 $ / shares shares | |
Inducement Grant [Abstract] | |
Granted (in shares) | 0 |
Shares outstanding (in shares) | 150,000 |
Weighted average exercise price (in dollars per share) | $ / shares | $ 2.42 |
Options vested and exercisable, Number of option vested (in shares) | 25,000 |
Options vested and exercisable, Weighted average exercise price (in dollars per shares) | $ / shares | $ 2.97 |
Equity Incentive Plans, Share-B
Equity Incentive Plans, Share-Based Compensation Expense (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-based Compensation Expense [Abstract] | ||
Share-based compensation expense | $ 56,954 | $ 44,359 |
Share-based compensation expense expected to be recognized for employees and nonemployees | 926,280 | |
Compensation expense to be recognized upon achieving certain performance condition | 463,311 | |
Unrecognized expenses | $ 462,969 | |
Weighted-average period over which unrecognized compensation is expected to be recognized | 2 years 8 months 12 days | |
Research and Development [Member] | ||
Share-based Compensation Expense [Abstract] | ||
Share-based compensation expense | $ 25,059 | 29,139 |
Sales and Marketing [Member] | ||
Share-based Compensation Expense [Abstract] | ||
Share-based compensation expense | (2,544) | 1,126 |
General and Administrative [Member] | ||
Share-based Compensation Expense [Abstract] | ||
Share-based compensation expense | $ 34,439 | $ 14,094 |
Equity Incentive Plans, Employe
Equity Incentive Plans, Employee Stock Purchase Plan (Details) - Employee Stock Purchase Plan [Member] | 3 Months Ended |
Mar. 31, 2023 shares | |
Employee Stock Purchase Plan [Abstract] | |
Stock issued (in shares) | 0 |
Common stock reserved for issuance (in shares) | 398,561 |
Net Loss per Share Attributab_3
Net Loss per Share Attributable to Common Stockholders (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Net Loss per Share Attributable to Common Stockholders [Abstract] | ||
Net loss attributable to common stockholders, basic | $ (2,946,257) | $ (2,883,030) |
Net loss attributable to common stockholders, diluted | $ (2,946,257) | $ (2,883,030) |
Weighted average number of shares used in computing net loss per share attributable to common stockholders, basic (in shares) | 11,872,255 | 11,804,165 |
Weighted average number of shares used in computing net loss per share attributable to common stockholders, diluted (in shares) | 11,872,255 | 11,804,165 |
Net loss per share attributable to common stockholders, basic (in dollars per share) | $ (0.25) | $ (0.24) |
Net loss per share attributable to common stockholders, diluted (in dollars per share) | $ (0.25) | $ (0.24) |
Weighted Average Number of Shares Outstanding [Abstract] | ||
Options to purchase common stock (in shares) | 1,036,495 | 1,055,997 |
Warrants to purchase to common stock (in shares) | 233,460 | 244,572 |
Total potential shares (in shares) | 1,269,955 | 1,300,569 |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent Event [Member] | Apr. 18, 2023 USD ($) $ / shares shares |
Issuance Sale of Common Stock [Abstract] | |
Issuance and sale of common stock (in shares) | shares | 3,196,722 |
Purchase price (in dollars per share) | $ / shares | $ 1.22 |
Warrants issued to purchase common stock (in shares) | shares | 3,196,722 |
Gross proceeds from offering | $ | $ 3,900,000 |
Net proceeds from offering | $ | $ 3,400,000 |