-- Femasys readies for the commercial launch of FemaSeed® in the U.S. amidst the uncertainty following the Alabama Supreme Court Ruling on how to handle embryos used for in vitro fertilization (IVF) -- -- Femasys to announce top-line data from recently completed pivotal clinical trial for FemaSeed in first quarter 2024 -- ATLANTA, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ:FEMY), a biomedical company focused on meeting the significant unmet needs for women worldwide with a broad portfolio of in- ...

-- Seasoned sales and marketing executive with 25 years of experience leading public and private healthcare companies throughout various stages of commercialization will lead commercial launch of FemaSeed -- ATLANTA, Feb. 06, 2024 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ:FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead, late-clinical stage product candidate and innovative therapeutic and dia ...

[FORM 10-Q Filing Information](index=1&type=section&id=FORM%2010-Q) [Registrant Information](index=1&type=section&id=Registrant%20Information) Femasys Inc. filed its Quarterly Report on Form 10-Q for the period ended September 30, 2023, is incorporated in Delaware, trades on Nasdaq under FEMY, and had 21,649,623 shares outstanding as of November 13, 2023 - Femasys Inc. filed its Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2023[2](index=2&type=chunk) - The registrant is a non-accelerated filer, a smaller reporting company, and an emerging growth company, electing not to use the extended transition period for new or revised financial accounting standards[3](index=3&type=chunk)[4](index=4&type=chunk) Registrant Key Information | Metric | Value | | :--- | :--- | | Commission file number | 001-40492 | | State of incorporation | Delaware | | Trading symbol | FEMY | | Exchange | The Nasdaq Capital Market | | Common stock outstanding (as of Nov 13, 2023) | 21,649,623 shares | [SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS](index=3&type=section&id=SPECIAL%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) [Forward-Looking Statements Disclaimer](index=3&type=section&id=Forward-Looking%20Statements%20Disclaimer) This quarterly report contains forward-looking statements based on current expectations and projections, which are subject to risks and uncertainties that may cause actual results to differ materially, and the company does not plan to update them publicly - This report contains forward-looking statements, identifiable by words like “may,” “will,” “expect,” “plan,” “believe,” “estimate,” and are based on the company's current expectations and projections regarding future events and financial trends[9](index=9&type=chunk)[11](index=11&type=chunk) - Forward-looking statements are inherently subject to known and unknown risks, uncertainties, and assumptions, including those described in “Risk Factors” and “Management's Discussion and Analysis of Financial Condition and Results of Operations,” where actual results may differ materially from projections[11](index=11&type=chunk) - The company does not plan to publicly update or revise any forward-looking statements, and these statements do not enjoy the safe harbor protection provided by the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933[11](index=11&type=chunk) [PART I. FINANCIAL INFORMATION](index=5&type=section&id=Part%20I.%20Financial%20Information) [ITEM I. Financial Statements](index=5&type=section&id=ITEM%20I.%20Financial%20Statements) This section presents Femasys Inc.'s unaudited consolidated financial statements, including balance sheets, statements of comprehensive loss, stockholders' equity, and cash flows, along with detailed notes explaining the company's organization, business, accounting policies, and specific financial items - The financial statements are unaudited and prepared in accordance with SEC rules and U.S. GAAP, with certain information and note disclosures condensed or omitted as permitted by these rules and regulations[32](index=32&type=chunk)[33](index=33&type=chunk) [Balance Sheets](index=5&type=section&id=Balance%20Sheets) As of September 30, 2023, Femasys Inc.'s total assets decreased by 12.1% to **$14.85 million** from **$16.90 million** at December 31, 2022, primarily due to reduced cash and cash equivalents, while total liabilities significantly increased by 166.8% to **$4.41 million**, and stockholders' equity declined by 31.5% to **$10.44 million** Key Balance Sheet Data (as of September 30) | Metric | 2023 | 2022 | Change | Change % | | :--- | :--- | :--- | :--- | :--- | | Total assets | $14,853,537 | $16,895,570 | $(2,042,033) | -12.1% | | Total liabilities | $4,409,935 | $1,653,051 | $2,756,884 | 166.8% | | Total stockholders' equity | $10,443,602 | $15,242,519 | $(4,798,917) | -31.5% | | Cash and cash equivalents | $8,692,435 | $12,961,936 | $(4,269,501) | -32.9% | | Total current assets | $10,225,032 | $14,131,491 | $(3,906,459) | -27.6% | | Total current liabilities | $2,186,947 | $1,527,809 | $659,138 | 43.1% | | Long-term lease liabilities | $2,168,969 | $28,584 | $2,140,385 | 7488.8% | [Statements of Comprehensive Loss](index=7&type=section&id=Statements%20of%20Comprehensive%20Loss) For the three months ended September 30, 2023, Femasys Inc. reported a net loss of **$4.00 million**, a 34.0% increase year-over-year, driven by a 29.7% sales decrease and a 29.5% rise in total operating expenses, while the nine-month net loss increased by 15.7% to **$9.84 million** due to similar operational expense growth Key Statements of Comprehensive Loss Data **For the Three Months Ended September 30:** | Metric | 2023 | 2022 | Change | Change % | | :--- | :--- | :--- | :--- | :--- | | Sales | $244,361 | $347,456 | $(103,095) | -29.7% | | Gross profit | $158,175 | $216,005 | $(57,830) | -26.8% | | R&D expenses | $2,072,830 | $1,648,160 | $424,670 | 25.8% | | Sales and marketing expenses | $70,883 | $90,374 | $(19,491) | -21.6% | | General and administrative expenses | $1,970,408 | $1,395,063 | $575,345 | 41.2% | | Total operating expenses | $4,239,439 | $3,273,194 | $966,245 | 29.5% | | Net loss | $(3,996,905) | $(2,982,843) | $(1,014,062) | 34.0% | | Net loss per share (basic and diluted) | $(0.26) | $(0.25) | $(0.01) | 4.0% | **For the Nine Months Ended September 30:** | Metric | 2023 | 2022 | Change | Change % | | :--- | :--- | :--- | :--- | :--- | | Sales | $858,859 | $971,974 | $(113,115) | -11.6% | | Gross profit | $557,084 | $615,495 | $(58,411) | -9.5% | | R&D expenses | $5,137,441 | $4,542,147 | $595,294 | 13.1% | | Sales and marketing expenses | $444,678 | $222,414 | $222,264 | 99.9% | | General and administrative expenses | $4,642,182 | $4,024,356 | $617,826 | 15.4% | | Total operating expenses | $10,615,984 | $9,215,397 | $1,400,587 | 15.2% | | Net loss | $(9,836,670) | $(8,499,974) | $(1,336,696) | 15.7% | | Net loss per share (basic and diluted) | $(0.74) | $(0.72) | $(0.02) | 2.8% | [Statements of Stockholders' Equity](index=8&type=section&id=Statements%20of%20Stockholders'%20Equity) As of September 30, 2023, total stockholders' equity was **$10.44 million**, a decrease from **$15.24 million** at December 31, 2022, primarily due to a **$9.84 million** net loss, partially offset by **$3.35 million** net proceeds from April 2023 financing, warrant exercises, and stock-based compensation Changes in Stockholders' Equity (Nine Months Ended September 30) | Item | Amount | | :--- | :--- | | Balance at December 31, 2022 | $15,242,519 | | Issuance of common stock and warrants from April 2023 financing (net of issuance costs) | $3,345,996 | | Exercise of prepaid warrants | $188 | | Exercise of common warrants | $1,059,975 | | Stock-based compensation expense | $626,529 | | Net loss | $(9,836,670) | | Balance at September 30, 2023 | $10,443,602 | [Statements of Cash Flows](index=10&type=section&id=Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2023, Femasys Inc.'s cash and cash equivalents decreased by **$4.27 million**, compared to an **$8.78 million** decrease in the prior year, with **$8.24 million** net cash used in operating activities, **$99 thousand** in investing activities, and **$4.07 million** net cash provided by financing activities, mainly from April 2023 equity financing and warrant exercises - In the first nine months of 2023, cash provided by financing activities primarily stemmed from **$4.97 million** in proceeds from the April 2023 issuance of common stock and warrants, along with proceeds from the exercise of prepaid and common warrants[115](index=115&type=chunk) Key Cash Flow Data (Nine Months Ended September 30) | Metric | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(8,244,566) | $(7,864,086) | | Net cash used in investing activities | $(99,018) | $(313,598) | | Net cash provided by/(used in) financing activities | $4,074,083 | $(599,695) | | Net change in cash and cash equivalents | $(4,269,501) | $(8,777,379) | | Cash and cash equivalents at end of period | $8,692,435 | $16,005,650 | [Notes to Financial Statements](index=11&type=section&id=Notes%20to%20Financial%20Statements) The notes provide detailed information on the company's organization, liquidity, accounting policies, inventory, accrued expenses, clinical holdback, revenue recognition, commitments, notes payable, leases, stockholders' equity, equity incentive plans, and net loss per share, highlighting the impact of April 2023 equity financing and subsequent warrant exercises on liquidity and equity - Femasys Inc. is a biomedical company focused on women's reproductive health, possessing an extensive intellectual property portfolio and in-house manufacturing capabilities, with key products including FemBloc® (permanent contraception) and FemaSeed® (intrauterine insemination)[30](index=30&type=chunk)[31](index=31&type=chunk) - As of September 30, 2023, the company had **$8.69 million** in cash and cash equivalents, with existing cash and recent financing proceeds expected to support operations for at least the next 12 months, though additional funding is required to advance FemBloc's clinical development and commercialization[35](index=35&type=chunk)[38](index=38&type=chunk)[107](index=107&type=chunk)[108](index=108&type=chunk) - In April 2023, the company completed an equity financing through a registered direct offering and concurrent private placement, generating **$3.90 million** in gross proceeds and **$3.35 million** net proceeds, followed by significant cash inflows from common warrant exercises in September and October 2023[56](index=56&type=chunk)[67](index=67&type=chunk)[72](index=72&type=chunk)[74](index=74&type=chunk)[106](index=106&type=chunk) [(1) Organization, Nature of Business, and Liquidity](index=11&type=section&id=(1)%20Organization,%20Nature%20of%20Business,%20and%20Liquidity) Femasys Inc. is a biomedical company focused on women's reproductive health, offering permanent contraception and infertility solutions with extensive IP and internal manufacturing, and while **$8.69 million** in cash as of September 30, 2023, is expected to fund operations for at least 12 months, additional financing is needed for FemBloc's clinical development and commercialization - Femasys Inc. is a biomedical company focused on women's reproductive health, offering solutions including FemBloc® (permanent contraception) and FemaSeed® (intrauterine insemination)[30](index=30&type=chunk)[31](index=31&type=chunk) - The company holds an extensive intellectual property portfolio, including design and utility patents in the U.S. and key overseas markets, and possesses in-house research, development, and manufacturing capabilities[31](index=31&type=chunk) - The company anticipates increased losses in the coming years until FemBloc receives FDA approval and market launch, planning to support operations and R&D through existing cash, equity/debt financing, and sales revenue from FemVue and FemaSeed[35](index=35&type=chunk)[36](index=36&type=chunk) Liquidity Overview | Metric | September 30, 2023 | | :--- | :--- | | Cash and cash equivalents | $8,692,435 | | Net loss for the nine months ended September 30, 2023 | $(9,836,670) | | Estimated future operating capital sufficiency | At least 12 months | [(2) Cash and Cash Equivalents](index=12&type=section&id=(2)%20Cash%20and%20Cash%20Equivalents) As of September 30, 2023, the company's money market funds within cash and cash equivalents totaled **$7.33 million**, a decrease from **$12.55 million** at December 31, 2022 Money Market Funds | Date | Amount | | :--- | :--- | | September 30, 2023 | $7,330,371 | | December 31, 2022 | $12,553,557 | | Change | $(5,223,186) | | Change % | -41.6% | [(3) Inventories](index=12&type=section&id=(3)%20Inventories) As of September 30, 2023, the company's net inventory increased to **$602.7 thousand** from **$436.7 thousand** at December 31, 2022, with growth in raw materials and finished goods offsetting a decline in work-in-process, and a reserve for slow-moving, obsolete, or unusable FemVue products was recorded - The reserve for slow-moving, obsolete, or unusable FemVue products increased from **$2,103** at December 31, 2022, to **$3,560** at September 30, 2023[42](index=42&type=chunk) Inventory Composition (Net) | Inventory Category | September 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Raw materials | $361,569 | $244,498 | | Work-in-process | $51,358 | $100,453 | | Finished goods | $189,741 | $91,772 | | Total net inventory | $602,668 | $436,723 | [(4) Accrued Expenses](index=12&type=section&id=(4)%20Accrued%20Expenses) As of September 30, 2023, total accrued expenses increased to **$569.4 thousand** from **$456.7 thousand** at December 31, 2022, primarily due to significant increases in compensation costs and director fees, partially offset by decreases in clinical trial costs and franchise taxes Accrued Expenses Composition | Accrued Expense Category | September 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Clinical trial costs | $313,029 | $333,440 | | Compensation costs | $155,192 | $85,191 | | Franchise taxes | $0 | $26,886 | | Director fees | $90,000 | $0 | | Other | $11,221 | $11,197 | | Total accrued expenses | $569,442 | $456,714 | [(5) Clinical Holdback](index=13&type=section&id=(5)%20Clinical%20Holdback) As of September 30, 2023, the clinical holdback liability balance was **$126.1 thousand**, with **$72.1 thousand** classified as current and **$54.0 thousand** as long-term, reflecting **$4,529** in new holdbacks and **$20,299** in payments during the period Changes in Clinical Holdback Liability (Nine Months Ended September 30) | Item | Amount | | :--- | :--- | | Balance at December 31, 2022 | $141,864 | | Clinical holdback retained | $4,529 | | Clinical holdback paid | $(20,299) | | Balance at September 30, 2023 | $126,094 | | Less: Current portion | $(72,075) | | Long-term portion | $54,019 | [(6) Revenue Recognition](index=13&type=section&id=(6)%20Revenue%20Recognition) The company primarily recognizes revenue from FemVue product sales at the point of shipment with standard 30-to-60-day payment terms, reporting **$800.8 thousand** in U.S. sales and **$58.0 thousand** in international sales for the first nine months of 2023, totaling **$858.9 thousand**, a decrease from the prior year, with no significant history of returns - The company recognizes revenue at the point of shipment based on contract pricing and standard 30-to-60-day payment terms, with all revenue recognized at a point in time and no over-time recognition[46](index=46&type=chunk)[119](index=119&type=chunk) - Products are shipped to U.S. customers via common carrier, with customers assuming freight costs and FOB shipping point control, while international distributors typically have EX-Works shipping terms, and the company has no significant history of returns[47](index=47&type=chunk)[120](index=120&type=chunk) Sales by Geographic Region (Primarily from FemVue) **For the Three Months Ended September 30:** | Market | 2023 | 2022 | | :--- | :--- | :--- | | U.S. | $244,361 | $289,642 | | International | $0 | $57,814 | | Total | $244,361 | $347,456 | **For the Nine Months Ended September 30:** | Market | 2023 | 2022 | | :--- | :--- | :--- | | U.S. | $800,814 | $856,115 | | International | $58,045 | $115,859 | | Total | $858,859 | $971,974 | [(7) Commitments and Contingencies](index=13&type=section&id=(7)%20Commitments%20and%20Contingencies) The company may be involved in legal claims or litigation but, as of September 30, 2023, and December 31, 2022, there were no material legal contingencies requiring accrual or disclosure, and the company indemnifies directors and officers under Delaware law and its bylaws, backed by D&O liability insurance - The company may be involved in legal claims or litigation, but as of September 30, 2023, and December 31, 2022, there were no material legal contingencies requiring accrual or disclosure[49](index=49&type=chunk) - The company indemnifies its directors and officers under Delaware law and its bylaws, and has purchased Directors and Officers liability insurance to limit potential unlimited indemnification amounts[50](index=50&type=chunk) [(8) Notes Payable](index=13&type=section&id=(8)%20Notes%20Payable) In July 2023, the company entered into a **$469.0 thousand** promissory note with AFCO Credit Corporation at an 8.587% annual interest rate to finance insurance premiums, resulting in an AFCO note principal balance of **$283.3 thousand** as of September 30, 2023, an increase from **$141.3 thousand** at December 31, 2022 - In July 2023, the company entered into a promissory note with AFCO Credit Corporation to finance **$469,042** in insurance premiums at an 8.587% annual interest rate[51](index=51&type=chunk) AFCO Notes Payable Principal Balance | Date | Amount | | :--- | :--- | | September 30, 2023 | $283,334 | | December 31, 2022 | $141,298 | | Change | $142,036 | | Change % | 100.5% | AFCO Notes Payable Interest Expense **For the Three Months Ended September 30:** | Year | Amount | | :--- | :--- | | 2023 | $7,998 | | 2022 | $5,352 | **For the Nine Months Ended September 30:** | Year | Amount | | :--- | :--- | | 2023 | $9,317 | | 2022 | $7,235 | [(9) Leases](index=14&type=section&id=(9)%20Leases) In July 2023, the company extended its operating lease agreement for its Suwanee, Georgia office facility, incurring **$3.32 million** in future payments over 63 months, which led to a **$2.50 million** increase in right-of-use assets and lease liabilities - In July 2023, the company extended its operating lease agreement, requiring **$3,321,025** in future payments over 63 months[54](index=54&type=chunk) - The lease extension resulted in a **$2,496,968** increase in right-of-use assets and lease liabilities[54](index=54&type=chunk) [(10) Stockholders' Equity](index=14&type=section&id=(10)%20Stockholders'%20Equity) As of September 30, 2023, the company had 15,992,869 shares of common stock outstanding with no dividends declared or paid, having completed an April 2023 equity financing that issued 1,318,000 common shares and warrants to purchase 3,196,722 common shares, generating **$3.90 million** gross and **$3.35 million** net proceeds, and also re-established an 'at-the-market' offering facility in October 2023 - In April 2023, the company completed an equity financing through a registered direct offering and concurrent private placement, issuing 1,318,000 shares of common stock and prepaid and common warrants to purchase 3,196,722 shares of common stock, generating **$3,899,813** in gross proceeds and **$3,352,049** in net proceeds[56](index=56&type=chunk)[106](index=106&type=chunk) - The company established an 'at-the-market' offering facility in July 2022 with Piper Sandler & Co., allowing for the issuance of up to **$8.80 million** in common stock, which was suspended in April 2023 and reinstated in October 2023, authorizing sales of up to **$16.70 million** in shares[55](index=55&type=chunk)[105](index=105&type=chunk) Common Stock Outstanding | Date | Shares Outstanding | | :--- | :--- | | September 30, 2023 | 15,992,869 | | November 13, 2023 | 21,649,623 | [(11) Equity Incentive Plans and Warrants](index=14&type=section&id=(11)%20Equity%20Incentive%20Plans%20and%20Warrants) As of September 30, 2023, the company had 2,079,271 stock options outstanding with a weighted-average exercise price of **$2.00**, having granted 1,150,000 employee options and 73,000 non-employee options in the first nine months of 2023, while prepaid warrants from the April 2023 financing were fully exercised by June 2023, and some common and placement agent warrants were exercised in September 2023, generating **$1.06 million** in cash, leaving 2,400,000 common warrants and 68,809 placement agent warrants unexercised - Prepaid warrants issued in the April 2023 financing were fully exercised by June 2023, and in September 2023, 796,722 common warrants and 122,994 placement agent warrants were exercised, generating **$1,059,975** in cash proceeds[72](index=72&type=chunk) - As of September 30, 2023, 2,400,000 common warrants and 68,809 placement agent warrants remained unexercised[72](index=72&type=chunk) Stock Option Activity (Nine Months Ended September 30) | Metric | Number of Stock Options | Weighted-Average Exercise Price | | :--- | :--- | :--- | | Outstanding at December 31, 2022 | 931,550 | $3.97 | | Granted | 1,223,000 | $0.50 (weighted average) | | Forfeited | (75,279) | $2.09 (weighted average) | | Outstanding at September 30, 2023 | 2,079,271 | $2.00 | | Vested and exercisable at September 30, 2023 | 1,217,298 | $2.62 | Stock-Based Compensation Expense **For the Three Months Ended September 30:** | Category | 2023 | 2022 | | :--- | :--- | :--- | | Research and development | $79,561 | $10,820 | | Sales and marketing | $623 | $1,515 | | General and administrative | $424,175 | $39,427 | | Total | $504,359 | $51,762 | **For the Nine Months Ended September 30:** | Category | 2023 | 2022 | | :--- | :--- | :--- | | Research and development | $131,812 | $73,395 | | Sales and marketing | $(1,319) | $3,857 | | General and administrative | $496,036 | $81,036 | | Total | $626,529 | $158,288 | [(12) Net Loss per Share Attributable to Common Stockholders](index=16&type=section&id=(12)%20Net%20Loss%20per%20Share%20Attributable%20to%20Common%20Stockholders) For the three and nine months ended September 30, 2023, basic and diluted net loss per share attributable to common stockholders was **$0.26** and **$0.74**, respectively, with all potentially dilutive securities, including stock options and warrants, excluded from diluted net loss per share calculations due to their anti-dilutive effect given the company's net loss position - Due to the company's net loss position, potentially dilutive securities such as stock options and warrants are excluded from diluted net loss per share calculations as they are anti-dilutive[73](index=73&type=chunk) Net Loss per Share Attributable to Common Stockholders **For the Three Months Ended September 30:** | Metric | 2023 | 2022 | | :--- | :--- | :--- | | Net loss attributable to common stockholders (basic and diluted) | $(3,996,905) | $(2,982,843) | | Weighted-average shares used in computing net loss per share (basic and diluted) | 15,093,147 | 11,813,610 | | Net loss per share (basic and diluted) | $(0.26) | $(0.25) | **For the Nine Months Ended September 30:** | Metric | 2023 | 2022 | | :--- | :--- | :--- | | Net loss attributable to common stockholders (basic and diluted) | $(9,836,670) | $(8,499,974) | | Weighted-average shares used in computing net loss per share (basic and diluted) | 13,369,462 | 11,810,289 | | Net loss per share (basic and diluted) | $(0.74) | $(0.72) | [(13) Subsequent Events](index=16&type=section&id=(13)%20Subsequent%20Events) In October 2023, 2,400,000 common warrants were exercised, generating **$2.63 million** in cash proceeds, and the company reactivated its 'at-the-market' offering agreement, selling 3,256,754 shares through this facility for **$7.66 million** in gross cash proceeds - In October 2023, 2,400,000 common warrants were exercised, generating **$2,628,000** in cash proceeds[74](index=74&type=chunk) - In October 2023, the company reactivated its 'at-the-market' offering agreement and sold 3,256,754 shares, generating **$7,661,587** in gross cash proceeds[74](index=74&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section discusses Femasys Inc.'s financial condition and operating results for the period ended September 30, 2023, covering company overview, recent corporate and clinical developments, operational performance, liquidity, capital resources, and critical accounting estimates, as the company advanced its reproductive health product pipeline and conducted financing activities - Femasys Inc. is a biomedical company focused on women's reproductive health, possessing an extensive intellectual property portfolio and in-house manufacturing capabilities, with key products including FemBloc (permanent contraception) and FemaSeed (intrauterine insemination)[77](index=77&type=chunk) - The company achieved several corporate and clinical milestones during the reporting period, including product approvals and FDA 510(k) clearance for FemaSeed in Canada, and FDA approval and enrollment initiation for FemBloc's pivotal clinical trial[78](index=78&type=chunk)[80](index=80&type=chunk)[82](index=82&type=chunk)[85](index=85&type=chunk)[86](index=86&type=chunk) - The company secured additional liquidity through equity financing and warrant exercises to support operations and product development, but still anticipates needing more capital to complete clinical development and commercialization of its primary product candidates[103](index=103&type=chunk)[105](index=105&type=chunk)[106](index=106&type=chunk)[108](index=108&type=chunk) [Overview](index=17&type=section&id=Overview) Femasys Inc. is a women-founded and led biomedical company dedicated to providing office-accessible solutions for women globally, leveraging its extensive IP portfolio and internal manufacturing capabilities, primarily focusing on reproductive health with FemBloc for permanent contraception and FemaSeed for intrauterine insemination, the latter receiving FDA 510(k) clearance in September 2023 - Femasys is a women-founded and led biomedical company focused on addressing unmet needs for women globally, offering a wide range of office-accessible solutions[77](index=77&type=chunk) - The company holds an intellectual property portfolio of over 150 global patents and possesses in-house chemistry, manufacturing, and control (CMC) as well as device manufacturing capabilities[77](index=77&type=chunk) - The company primarily focuses on reproductive health, with key product candidates including FemBloc for permanent contraception and FemaSeed for intrauterine insemination, which received FDA 510(k) clearance in September 2023[77](index=77&type=chunk) [Corporate Update](index=17&type=section&id=Corporate%20Update) Femasys Inc. achieved significant corporate milestones, including Health Canada approval for FemaSeed, FemCerv, and FemCath sales, FDA IDE approval and enrollment initiation for FemBloc's pivotal clinical trial, a new U.S. patent for FemBloc, FDA 510(k) clearance for FemaSeed, a Health Canada medical device establishment license, and regaining Nasdaq minimum bid price compliance - Health Canada approved the sale of FemaSeed, FemCerv, and FemCath in Canada[78](index=78&type=chunk)[79](index=79&type=chunk)[80](index=80&type=chunk) - The FDA approved the IDE for FemBloc's pivotal clinical trial, with enrollment initiated in August 2023[80](index=80&type=chunk)[81](index=81&type=chunk) - The company received FDA 510(k) clearance for FemaSeed in September 2023 and a Health Canada Medical Device Establishment License in August 2023, enabling direct sales of FemaSeed, FemVue, FemCath, and FemCerv in Canada[82](index=82&type=chunk) - The company regained Nasdaq minimum bid price compliance in October 2023[83](index=83&type=chunk) [Clinical Update](index=18&type=section&id=Clinical%20Update) Femasys Inc. advanced its clinical development, with FemaSeed's pivotal trial redesigned to focus on male factor infertility patients, expected to complete enrollment in Q4 2023 and receiving FDA 510(k) clearance in September 2023, while FemBloc's FINALE pivotal trial received FDA IDE approval and commenced enrollment to assess safety and efficacy, with pregnancy rate as the primary endpoint, and plans for an interim analysis and five-year follow-up - FemaSeed's pivotal trial design was updated to focus on male factor infertility patients, with enrollment expected to complete in Q4 2023, and received FDA 510(k) clearance in September 2023[85](index=85&type=chunk) - FemBloc's FINALE pivotal trial received FDA IDE approval and initiated enrollment, aiming to evaluate its safety and effectiveness, with pregnancy rate as the primary endpoint[86](index=86&type=chunk) - The FemBloc trial design includes an initial safety data enrollment of 50 women, a clinical data endpoint interim analysis after 300 women use FemBloc for one year, and planned five-year annual follow-ups[86](index=86&type=chunk) [Results of Operations](index=18&type=section&id=Results%20of%20Operations) For the three and nine months ended September 30, 2023, Femasys Inc. experienced decreased sales but improved gross margins, while increased research and development, sales and marketing, and general and administrative expenses led to expanded operating and net losses, partially offset by significant growth in interest income Operating Results Overview **For the Three Months Ended September 30:** | Metric | 2023 | 2022 | Change | Change % | | :--- | :--- | :--- | :--- | :--- | | Sales | $244,361 | $347,456 | $(103,095) | -29.7% | | Gross profit | $158,175 | $216,005 | $(57,830) | -26.8% | | Total operating expenses | $4,239,439 | $3,273,194 | $966,245 | 29.5% | | Operating loss | $(4,081,264) | $(3,057,189) | $(1,024,075) | 33.5% | | Net loss | $(3,996,905) | $(2,982,843) | $(1,014,062) | 34.0% | **For the Nine Months Ended September 30:** | Metric | 2023 | 2022 | Change | Change % | | :--- | :--- | :--- | :--- | :--- | | Sales | $858,859 | $971,974 | $(113,115) | -11.6% | | Gross profit | $557,084 | $615,495 | $(58,411) | -9.5% | | Total operating expenses | $10,615,984 | $9,215,397 | $1,400,587 | 15.2% | | Operating loss | $(10,058,900) | $(8,599,902) | $(1,458,998) | 17.0% | | Net loss | $(9,836,670) | $(8,499,974) | $(1,336,696) | 15.7% | [Comparison of the Three Months Ended September 30, 2023 and 2022](index=18&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20September%2030,%202023%20and%202022) For the three months ended September 30, 2023, sales decreased by 29.7% to **$244.4 thousand**, driven by reduced international and U.S. sales, yet gross margin improved from 62.2% to 64.7% due to manufacturing efficiencies, while R&D expenses rose 25.8% to **$2.07 million**, sales and marketing expenses fell 21.6%, general and administrative expenses increased 41.2%, and net loss expanded by 34.0% to **$4.00 million** - Net other income (expense) increased by 13.5% to **$84.4 thousand**, primarily due to higher interest income[94](index=94&type=chunk) Operating Results for the Three Months Ended September 30 | Metric | 2023 | 2022 | Change | Change % | | :--- | :--- | :--- | :--- | :--- | | Sales | $244,361 | $347,456 | $(103,095) | -29.7% | | Cost of sales | $86,186 | $131,451 | $(45,265) | -34.4% | | Gross profit | $158,175 | $216,005 | $(57,830) | -26.8% | | Gross margin percentage | 64.7% | 62.2% | 2.5% | 4.0% | | Research and development expenses | $2,072,830 | $1,648,160 | $424,670 | 25.8% | | Sales and marketing expenses | $70,883 | $90,374 | $(19,491) | -21.6% | | General and administrative expenses | $1,970,408 | $1,395,063 | $575,345 | 41.2% | | Net loss | $(3,996,905) | $(2,982,843) | $(1,014,062) | 34.0% | [Comparison of the Nine months ended September 30, 2023 and 2022](index=19&type=section&id=Comparison%20of%20the%20Nine%20months%20ended%20September%2030,%202023%20and%202022) For the nine months ended September 30, 2023, sales decreased by 11.6% to **$858.9 thousand**, primarily due to reduced international and U.S. sales, while gross margin improved from 63.3% to 64.9%, R&D expenses increased 13.1% to **$5.14 million**, sales and marketing expenses surged 99.9% to **$444.7 thousand**, general and administrative expenses rose 15.4%, and net loss expanded by 15.7% to **$9.84 million** - Net other income (expense) significantly increased by 122.4% to **$222.2 thousand**, primarily due to higher interest income[102](index=102&type=chunk) Operating Results for the Nine Months Ended September 30 | Metric | 2023 | 2022 | Change | Change % | | :--- | :--- | :--- | :--- | :--- | | Sales | $858,859 | $971,974 | $(113,115) | -11.6% | | Cost of sales | $301,775 | $356,479 | $(54,704) | -15.3% | | Gross profit | $557,084 | $615,495 | $(58,411) | -9.5% | | Gross margin percentage | 64.9% | 63.3% | 1.6% | 2.5% | | Research and development expenses | $5,137,441 | $4,542,147 | $595,294 | 13.1% | | Sales and marketing expenses | $444,678 | $222,414 | $222,264 | 99.9% | | General and administrative expenses | $4,642,182 | $4,024,356 | $617,826 | 15.4% | | Net loss | $(9,836,670) | $(8,499,974) | $(1,336,696) | 15.7% | [Liquidity and Capital Resources](index=20&type=section&id=Liquidity%20and%20Capital%20Resources) As of September 30, 2023, the company held **$8.69 million** in cash and cash equivalents with an accumulated deficit of **$104 million**, primarily funding operations through common stock, convertible preferred stock, and debt financing, having recently secured significant cash inflows from its 'at-the-market' facility and April 2023 financing, and expects existing funds to support operations for at least 12 months, though additional financing is required for clinical development and commercialization of key product candidates - The company primarily funds its operations through the sale of common stock, convertible preferred stock, debt, and product revenue[103](index=103&type=chunk) - In October 2023, the company sold 3,256,754 shares through its reinstated 'at-the-market' facility, generating **$7,661,587** in gross cash proceeds, in addition to **$3,352,049** net proceeds from the April 2023 financing and further cash inflows from warrant exercises in September and October 2023[105](index=105&type=chunk)[106](index=106&type=chunk) - The company anticipates needing additional capital to complete clinical development, regulatory approval, development, and commercialization of its primary product candidates, warning that failure to obtain sufficient financing may force termination or delay of product development[108](index=108&type=chunk) Liquidity Overview | Metric | September 30, 2023 | | :--- | :--- | | Cash and cash equivalents | $8,692,435 | | Accumulated deficit | $(103,971,175) | | Estimated time existing funds can support operations | At least 12 months | [Cash Flows](index=21&type=section&id=Cash%20Flows) For the nine months ended September 30, 2023, net cash used in operating activities was **$8.24 million**, primarily due to net loss, partially offset by non-cash expenses and changes in working capital, while net cash used in investing activities was **$99 thousand** for property and equipment, and net cash provided by financing activities was **$4.07 million**, mainly from equity issuance and warrant exercises - Net cash used in operating activities for the first nine months of 2023 was primarily attributable to a **$9,836,670** net loss, partially offset by non-cash expenses such as depreciation and amortization, right-of-use asset amortization, stock-based compensation expense, and loss on disposal of assets[110](index=110&type=chunk) - Net cash provided by financing activities for the first nine months of 2023 primarily resulted from **$4,965,021** in proceeds from the issuance of common stock and warrants, partially offset by financing issuance costs, notes payable repayments, and lease obligation payments[115](index=115&type=chunk) Cash Flow Overview (Nine Months Ended September 30) | Cash Flow Category | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(8,244,566) | $(7,864,086) | | Net cash used in investing activities | $(99,018) | $(313,598) | | Net cash provided by/(used in) financing activities | $4,074,083 | $(599,695) | | Net change in cash and cash equivalents | $(4,269,501) | $(8,777,379) | [Critical Accounting Estimates](index=22&type=section&id=Critical%20Accounting%20Estimates) This section discusses critical accounting estimates involved in preparing the company's financial statements, including revenue recognition and accrued expenses, where financial statements are prepared under U.S. GAAP requiring estimates and assumptions for assets, liabilities, revenue, and expenses, with revenue recognized when control of goods transfers and accrued expenses estimated for unbilled third-party R&D services - The company's financial statements are prepared in accordance with U.S. GAAP, requiring estimates and assumptions for assets, liabilities, revenue, expenses, and related disclosures[117](index=117&type=chunk) - Revenue is recognized when customers obtain control of promised goods, with all revenue recognized at a point in time and no over-time recognition, and the company has no multiple performance obligations or significant history of returns[119](index=119&type=chunk)[120](index=120&type=chunk) - Accrued expenses primarily relate to research and development activities by third-party service providers, estimated based on services rendered but not yet invoiced, and are adjusted to actual costs[121](index=121&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=22&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states that quantitative and qualitative disclosures about market risk are not applicable - Quantitative and qualitative disclosures about market risk are not applicable to this section[122](index=122&type=chunk) [Item 4. Controls and Procedures](index=22&type=section&id=Item%204.%20Controls%20and%20Procedures) Company management assessed the effectiveness of disclosure controls and procedures as of September 30, 2023, concluding they were effective at a reasonable assurance level, with no significant changes in internal control over financial reporting during the period, while acknowledging inherent limitations of control systems in preventing all errors and fraud - Company management, including the Chief Executive Officer and Chief Financial Officer, assessed the effectiveness of disclosure controls and procedures as of September 30, 2023, concluding they were effective at a reasonable assurance level[123](index=123&type=chunk) - No significant changes in internal control over financial reporting occurred during the quarter ended September 30, 2023[124](index=124&type=chunk) - Management acknowledges that all control systems have inherent limitations, providing reasonable rather than absolute assurance, and cannot prevent all errors and fraud[125](index=125&type=chunk) [PART II. OTHER INFORMATION](index=23&type=section&id=PART%20II%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=23&type=section&id=Item%201.%20Legal%20Proceedings) The company may be involved in legal proceedings, but currently believes the aggregate reasonably possible losses beyond established reserves will not materially impact consolidated financial condition or cash flows, though losses could significantly affect operating results in any specific future period - The company may be involved in legal proceedings from time to time, but currently believes the aggregate reasonably possible losses beyond established reserves will not materially impact consolidated financial condition or cash flows[127](index=127&type=chunk) - Nevertheless, losses could materially affect operating results for any particular future period, depending on the level of income for that period[127](index=127&type=chunk) [Item 1A. Risk Factors](index=23&type=section&id=Item%201A.%20Risk%20Factors) As of the report date, there have been no material changes to the risk factors disclosed in the company's Form 10-K annual report filed on December 31, 2022 - As of the date of this report, there have been no material changes to the risk factors disclosed in the company's Form 10-K annual report filed on December 31, 2022[128](index=128&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=23&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During the reporting period, the company had no unregistered sales of equity securities or use of proceeds - During the reporting period, the company had no unregistered sales of equity securities or use of proceeds[129](index=129&type=chunk) [Item 3. Defaults Upon Senior Securities](index=23&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) During the reporting period, the company had no defaults upon senior securities - During the reporting period, the company had no defaults upon senior securities[130](index=130&type=chunk) [Item 4. Mine Safety Disclosures](index=23&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section states that mine safety disclosures are not applicable - Mine safety disclosures are not applicable to this section[131](index=131&type=chunk) [Item 5. Other Information](index=23&type=section&id=Item%205.%20Other%20Information) During the quarter, no directors or officers adopted or terminated Rule 10b5-1 trading arrangements or non-Rule 10b5-1 trading arrangements - During the quarter covered by this report, no directors or officers adopted or terminated Rule 10b5-1 trading arrangements or non-Rule 10b5-1 trading arrangements[132](index=132&type=chunk) [Item 6. Exhibits](index=24&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with this quarterly report, including articles of incorporation, certification documents, and XBRL data files - Exhibits include articles of incorporation, amended bylaws, certifications of the Chief Executive Officer and Chief Financial Officer (pursuant to Exchange Act Rule 13a-14(a) and 18 U.S.C. Section 1350), and Inline XBRL instance and taxonomy extension files[134](index=134&type=chunk) [SIGNATURES](index=25&type=section&id=SIGNATURES) This quarterly report was formally signed on November 14, 2023, by Kathy Lee-Sepsick, Chief Executive Officer and President, and Dov Elefant, Chief Financial Officer, of Femasys Inc. - This registration statement was signed on November 14, 2023, by Kathy Lee-Sepsick, Chief Executive Officer and President, and Dov Elefant, Chief Financial Officer, of Femasys Inc.[135](index=135&type=chunk)[136](index=136&type=chunk)

[FORM 10-Q Filing Information](index=1&type=section&id=FORM%2010-Q%20Filing%20Information) Details the company's quarterly report filing, including registrant information, filer status, and securities outstanding - Registrant: Femasys Inc., incorporated in Delaware, headquartered in Suwanee, GA[2](index=2&type=chunk)[3](index=3&type=chunk) - Filing Type: Quarterly Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the period ended **June 30, 2023**[2](index=2&type=chunk) - Filer Status: Non-accelerated filer, Smaller reporting company, Emerging growth company[3](index=3&type=chunk)[4](index=4&type=chunk) Securities Registered | Title of each class | Trading symbol | Name of each exchange on which registered | |---|---|---| | Common stock, $0.001 par value | FEMY | The Nasdaq Capital Market | - Shares Outstanding: **15,073,153** shares of common stock as of **August 9, 2023**[4](index=4&type=chunk) [Special Note Regarding Forward-Looking Statements](index=3&type=section&id=SPECIAL%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section cautions readers about forward-looking statements, highlighting inherent risks and the company's policy against public updates - Forward-looking statements are identified by terms such as 'may,' 'will,' 'should,' 'expect,' 'plan,' 'anticipate,' 'could,' 'intend,' 'target,' 'project,' 'contemplate,' 'believe,' 'estimate,' 'predict,' 'potential' or 'continue' or similar expressions[9](index=9&type=chunk) - Key areas covered by forward-looking statements include product development, clinical trials, regulatory approvals (FDA), financing, market competition, commercialization, reimbursement, manufacturing, and intellectual property[10](index=10&type=chunk) - Readers are cautioned that these statements are predictions based on current expectations and are subject to risks and uncertainties, including those detailed in 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operations'[11](index=11&type=chunk) - The company does not plan to publicly update or revise any forward-looking statements, and they are excluded from the safe harbor protection of the Private Securities Litigation Reform Act of 1995[11](index=11&type=chunk) [Part I. Financial Information](index=5&type=section&id=Part%20I.%20Financial%20Information) This part presents the company's unaudited interim financial statements and management's discussion and analysis of financial condition and results of operations [Item 1. Financial Statements](index=5&type=section&id=Item%201%20Financial%20Statements) This section presents the unaudited interim financial statements of Femasys Inc. for the periods ended June 30, 2023, and December 31, 2022, including Balance Sheets, Statements of Comprehensive Loss, Stockholders' Equity, and Cash Flows, along with detailed accompanying notes. These statements provide a snapshot of the company's financial position, performance, and cash flows, highlighting ongoing losses and liquidity challenges [Balance Sheets](index=5&type=section&id=Balance%20Sheets%20as%20of%20June%2030%2C%202023%20and%20December%2031%2C%202022%20(unaudited)) Presents the company's financial position, detailing assets, liabilities, and equity for the reported periods Key Balance Sheet Data | Metric | June 30, 2023 | December 31, 2022 | |---|---|---| | Cash and cash equivalents | $10,705,017 | $12,961,936 | | Total current assets | $12,030,065 | $14,131,491 | | Total assets | $14,313,961 | $16,895,570 | | Total current liabilities | $1,381,543 | $1,527,809 | | Total liabilities | $1,437,788 | $1,653,051 | | Total stockholders' equity | $12,876,173 | $15,242,519 | | Accumulated deficit | $(99,974,270) | $(94,134,505) | - Cash and cash equivalents decreased by **$2,256,919** from **December 31, 2022**, to **June 30, 2023**[15](index=15&type=chunk) - Total assets decreased by **$2,581,609**, and total stockholders' equity decreased by **$2,366,346** during the six-month period[15](index=15&type=chunk)[17](index=17&type=chunk) - Accumulated deficit increased by **$5,839,765**, reflecting the net loss for the period[17](index=17&type=chunk) [Statements of Comprehensive Loss](index=7&type=section&id=Statements%20of%20Comprehensive%20Loss%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202023%20and%202022%20(unaudited)) Details the company's revenues, expenses, and net loss for the three and six months ended June 30 Comprehensive Loss (Three Months Ended June 30) | Metric | 2023 | 2022 | Change | % Change | |---|---|---|---|---| | Sales | $320,514 | $303,113 | $17,401 | 5.7% | | Gross margin | $210,045 | $200,760 | $9,285 | 4.6% | | Total operating expenses | $3,146,007 | $2,860,723 | $285,284 | 10.0% | | Net loss | $(2,893,508) | $(2,634,101) | $(259,407) | 9.8% | | Net loss per share (basic & diluted) | $(0.22) | $(0.22) | $0.00 | 0.0% | Comprehensive Loss (Six Months Ended June 30) | Metric | 2023 | 2022 | Change | % Change | |---|---|---|---|---| | Sales | $614,498 | $624,518 | $(10,020) | -1.6% | | Gross margin | $398,909 | $399,490 | $(581) | -0.1% | | Total operating expenses | $6,376,545 | $5,942,203 | $434,342 | 7.3% | | Net loss | $(5,839,765) | $(5,517,131) | $(322,634) | 5.8% | | Net loss per share (basic & diluted) | $(0.47) | $(0.47) | $0.00 | 0.0% | - Sales and marketing expenses significantly increased by **104%** for the three months and **183.1%** for the six months ended **June 30, 2023**, reflecting increased commercial efforts[20](index=20&type=chunk) - Interest income saw a substantial increase, rising by **59.5%** for the three months and **378.6%** for the six months ended **June 30, 2023**[20](index=20&type=chunk) [Statements of Stockholders' Equity](index=8&type=section&id=Statements%20of%20Stockholders'%20Equity%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202023%20and%202022%20(unaudited)) Outlines changes in stockholders' equity, including net loss, stock issuances, and share-based compensation, for the reported periods Stockholders' Equity Changes (Six Months Ended June 30, 2023) | Item | Amount | |---|---| | Balance at December 31, 2022 | $15,242,519 | | Issuance of common stock and warrants (April 2023 Financing) | $3,345,996 | | Exercise of pre-funded warrants | $188 | | Share-based compensation expense | $122,170 | | Net loss | $(5,839,765) | | Balance at June 30, 2023 | $12,876,173 | - Total stockholders' equity decreased from **$15,242,519** at **December 31, 2022**, to **$12,876,173** at **June 30, 2023**[23](index=23&type=chunk) - The **April 2023** Financing resulted in the issuance of **1,318,000** shares of common stock and warrants, contributing **$3,345,996** to equity[23](index=23&type=chunk) - Accumulated deficit increased by **$5,839,765** due to the net loss for the six months ended **June 30, 2023**[23](index=23&type=chunk) [Statements of Cash Flows](index=10&type=section&id=Statements%20of%20Cash%20Flows%20for%20the%20Six%20Months%20Ended%20June%2030%2C%202023%20and%202022%20(unaudited)) Summarizes cash flows from operating, investing, and financing activities for the six months ended June 30 Cash Flow Summary (Six Months Ended June 30) | Activity | 2023 | 2022 | |---|---|---| | Net cash used in operating activities | $(5,388,824) | $(5,133,896) | | Net cash used in investing activities | $(71,849) | $(295,058) | | Net cash provided by (used in) financing activities | $3,203,754 | $(237,656) | | Net change in cash and cash equivalents | $(2,256,919) | $(5,666,610) | | Cash and cash equivalents, end of period | $10,705,017 | $19,116,419 | - Cash used in operating activities increased to **$5,388,824** in 2023 from **$5,133,896** in 2022, mainly due to the net loss[29](index=29&type=chunk) - Financing activities provided **$3,203,754** in 2023, a significant improvement from cash used of **$237,656** in 2022, primarily due to proceeds from the **April 2023** financing (**$3,899,813** gross)[29](index=29&type=chunk) - Purchases of property and equipment decreased significantly from **$295,058** in 2022 to **$71,849** in 2023[29](index=29&type=chunk) [Notes to Financial Statements](index=11&type=section&id=Notes%20to%20Financial%20Statements%20(unaudited)) Provides detailed explanations and additional information supporting the unaudited interim financial statements [Note 1: Organization, Nature of Business, and Liquidity](index=11&type=section&id=(1)%20Organization%2C%20Nature%20of%20Business%2C%20and%20Liquidity) Describes Femasys Inc.'s business, product candidates, and assesses its liquidity and going concern status - Femasys is a biomedical company focused on women's reproductive health, developing minimally invasive, in-office technologies for permanent birth control (FemBloc) and infertility (FemaSeed)[32](index=32&type=chunk)[33](index=33&type=chunk) - Key product candidates include FemBloc (FDA IDE approved for pivotal trial in **June 2023**), FemaSeed (FDA IDE approved, trial ongoing, approved for sale in Canada), FemVue (approved in U.S., Japan, Canada), FemChec, FemCath (approved in U.S., Canada), and FemCerv (approved in U.S., Canada)[33](index=33&type=chunk) - The company had **$10,705,017** in cash and cash equivalents as of **June 30, 2023**, and an accumulated deficit of **$99,974,270**[37](index=37&type=chunk)[41](index=41&type=chunk) - Femasys expects to incur additional losses and negative operating cash flows for at least the next **twelve months**, leading to substantial doubt about its ability to continue as a going concern[38](index=38&type=chunk)[41](index=41&type=chunk) - The company plans to finance operations through existing cash, additional equity/debt financing, and revenue from FemVue sales, but there's no assurance of obtaining sufficient funds[37](index=37&type=chunk) [Note 2: Cash and Cash Equivalents](index=12&type=section&id=(2)%20Cash%20and%20Cash%20Equivalents) Details the composition of cash and cash equivalents, primarily money market funds, and their fair value classification Money Market Funds in Cash and Cash Equivalents | Date | Amount | |---|---| | June 30, 2023 | $10,038,944 | | December 31, 2022 | $12,553,557 | - Money market funds represent **Level 1** within the fair value hierarchy, indicating quoted prices in active markets for identical assets[44](index=44&type=chunk) [Note 3: Inventories](index=12&type=section&id=(3)%20Inventories) Provides a breakdown of inventory components and the reserve for slow-moving or obsolete items Inventory Composition (Net of Reserve) | Category | June 30, 2023 | December 31, 2022 | |---|---|---| | Materials | $356,274 | $244,498 | | Work in progress | $71,081 | $100,453 | | Finished goods | $154,119 | $91,772 | | Total Inventory, net | $581,474 | $436,723 | - The reserve for slow-moving, obsolete, or unusable FemVue inventories increased from **$2,103** at **December 31, 2022**, to **$3,091** at **June 30, 2023**[45](index=45&type=chunk) [Note 4: Accrued Expenses](index=12&type=section&id=(4)%20Accrued%20Expenses) Details the composition of accrued expenses, including clinical trial costs, compensation, and director fees Accrued Expenses Composition | Category | June 30, 2023 | December 31, 2022 | |---|---|---| | Clinical trial costs | $295,582 | $333,440 | | Compensation costs | $129,323 | $85,191 | | Director fees | $90,424 | $0 | | Total Accrued expenses | $536,830 | $456,714 | - Director fees accrued significantly increased from **$0** to **$90,424**[46](index=46&type=chunk) [Note 5: Clinical Holdback](index=13&type=section&id=(5)%20Clinical%20Holdback) Outlines the activity and classification of the clinical holdback liability Clinical Holdback Liability Activity | Item | Amount | |---|---| | Balance at December 31, 2022 | $141,864 | | Clinical holdback retained | $3,447 | | Clinical holdback paid | $(328) | | Balance at June 30, 2023 | $144,983 | | Current portion | $(88,738) | | Long-term portion | $56,245 | [Note 6: Revenue Recognition](index=13&type=section&id=(6)%20Revenue%20Recognition) Explains the company's revenue recognition policies and presents sales data by geographic region - Revenue is recognized upon shipment of goods, with standard payment terms of **30 to 60** days, and no revenue is recognized over time[49](index=49&type=chunk) - The company has not had a history of significant returns[50](index=50&type=chunk) Sales by Geographic Region (Three Months Ended June 30) | Region | 2023 | 2022 | |---|---|---| | U.S. | $262,469 | $303,113 | | International | $58,045 | $0 | | Total | $320,514 | $303,113 | Sales by Geographic Region (Six Months Ended June 30) | Region | 2023 | 2022 | |---|---|---| | U.S. | $556,453 | $566,473 | | International | $58,045 | $58,045 | | Total | $614,498 | $624,518 | [Note 7: Commitments and Contingencies](index=13&type=section&id=(7)%20Commitments%20and%20Contingencies) Addresses potential legal contingencies and indemnification obligations for officers and directors - No material legal contingencies required accrual or disclosure for the periods presented[52](index=52&type=chunk) - The company indemnifies its officers and directors, with the maximum potential future indemnification being unlimited, but exposure is limited by director and officer insurance[53](index=53&type=chunk) [Note 8: Notes Payable](index=13&type=section&id=(8)%20Notes%20Payable) Details the principal balance and interest expense related to AFCO promissory notes AFCO Promissory Notes Principal Balance | Date | Principal Balance | |---|---| | June 30, 2023 | $0 | | December 31, 2022 | $141,298 | Interest Expense on AFCO Notes | Period | 2023 | 2022 | |---|---|---| | Three Months Ended June 30 | $1,319 | $86 | | Six Months Ended June 30 | $1,319 | $1,882 | [Note 9: Stockholders' Equity](index=14&type=section&id=(9)%20Stockholders'%20Equity) Describes significant changes in stockholders' equity, including recent financing activities and outstanding shares - In **April 2023**, the company completed a registered direct offering and concurrent private placement, selling **1,318,000** shares of common stock and pre-funded warrants for **1,878,722** shares, along with common warrants for **3,196,722** shares[58](index=58&type=chunk) - The **April 2023** Financing generated gross proceeds of **$3,899,813**, with net proceeds of **$3,352,049** after fees and expenses[58](index=58&type=chunk) - The at-the-market facility with Piper Sandler & Co. was suspended in **April 2023**, after selling **2,869** shares for the six months ended **June 30, 2023**[57](index=57&type=chunk) - As of **June 30, 2023**, **15,073,153** shares of common stock were outstanding, and no dividends have been declared or paid[59](index=59&type=chunk) [Note 10: Equity Incentive Plans and Warrants](index=14&type=section&id=(10)%20Equity%20Incentive%20Plans%20and%20Warrants) Provides details on stock option activity, share-based compensation, and outstanding warrants Stock Option Activity (Six Months Ended June 30, 2023) | Item | Number of options | Weighted average exercise price | |---|---|---| | Outstanding at December 31, 2022 | 931,550 | $3.97 | | Granted | 158,200 | $0.80 (avg) | | Forfeited | (70,079) | $2.40 (avg) | | Outstanding at June 30, 2023 | 1,019,671 | $3.57 | | Vested and exercisable at June 30, 2023 | 511,472 | $3.09 | Share-Based Compensation Expense (Six Months Ended June 30) | Category | 2023 | 2022 | |---|---|---| | Research and development | $52,251 | $62,575 | | Sales and marketing | $(1,942) | $2,342 | | General and administrative | $71,861 | $41,609 | | Total share-based compensation expense | $122,170 | $106,526 | - All pre-funded warrants issued in the **April 2023** financing were exercised for common stock in **June 2023**[70](index=70&type=chunk) - As of **June 30, 2023**, common warrants and placement agent warrants from the **April 2023** financing remained outstanding[70](index=70&type=chunk) [Note 11: Net Loss per Share Attributable to Common Stockholders](index=16&type=section&id=(11)%20Net%20Loss%20per%20Share%20Attributable%20to%20Common%20Stockholders) Presents basic and diluted net loss per share and weighted average shares outstanding for the reported periods Net Loss per Share (Basic & Diluted) | Period | 2023 | 2022 | |---|---|---| | Three Months Ended June 30 | $(0.22) | $(0.22) | | Six Months Ended June 30 | $(0.47) | $(0.47) | Weighted Average Shares Outstanding | Period | 2023 | 2022 | |---|---|---| | Three Months Ended June 30 | 13,107,590 | 11,812,988 | | Six Months Ended June 30 | 12,493,334 | 11,808,601 | - Potentially dilutive securities, including options and warrants, were excluded from diluted EPS calculations because they were anti-dilutive[73](index=73&type=chunk) [Note 12: Subsequent Events](index=16&type=section&id=(12)%20Subsequent%20Events) Reports significant events occurring after the balance sheet date, including new financing and lease extensions - On **July 11, 2023**, the company executed a promissory note with AFCO for **$420,618** to finance insurance premiums[74](index=74&type=chunk) - On **July 17, 2023**, the operating lease for facilities in Suwanee, GA, was extended for an additional **63 months** through **April 2029**, obligating the company to **$3,321,025** in payments[75](index=75&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on Femasys Inc.'s financial condition, results of operations, and liquidity for the periods presented. It highlights product development progress, recent corporate and clinical updates, and a detailed analysis of revenue, expenses, and cash flows, emphasizing the company's ongoing net losses and need for additional financing to support its biomedical product pipeline [Overview](index=17&type=section&id=Overview) Provides a high-level introduction to Femasys Inc.'s business, product development, and intellectual property portfolio - Femasys is a biomedical company developing minimally invasive, in-office technologies for reproductive health, with an expansive intellectual property portfolio of over **150** global patents[78](index=78&type=chunk) - The company's lead product candidates are FemBloc for permanent birth control and FemaSeed for artificial insemination infertility treatment, targeting multi-billion dollar markets with little prior advancement[78](index=78&type=chunk) [Corporate Update](index=17&type=section&id=Corporate%20Update) Highlights recent corporate milestones, including product approvals and patent allowances - **April 18, 2023**: Health Canada granted product approval for FemaSeed, an artificial insemination solution[79](index=79&type=chunk) - **May 3, 2023**: Health Canada granted product approval for FemCerv, an endocervical tissue sampler[80](index=80&type=chunk) - **June 8, 2023**: Health Canada granted product approval for FemCath, an intrauterine catheter[81](index=81&type=chunk) - **June 26, 2023**: FDA approved the Investigational Device Exemption (IDE) for FemBloc's pivotal clinical trial for permanent birth control[81](index=81&type=chunk) - **July 27, 2023**: Notice of allowance for a new U.S. patent application covering FemBloc for female permanent birth control[82](index=82&type=chunk) - **August 3, 2023**: Initiation of enrollment in FemBloc's pivotal trial[83](index=83&type=chunk) [Clinical Update](index=17&type=section&id=Clinical%20Update) Details the progress and design of key clinical trials for FemaSeed and FemBloc - FemaSeed pivotal trial: Updated design focuses on male factor infertility to accelerate enrollment, with completion expected in **Q4 2023** and FDA submission planned thereafter[84](index=84&type=chunk) - FemaSeed enrollment slowdowns are attributed to consolidation activities, staffing shortages at clinical trial sites, and uncertainty surrounding abortion policy proposals affecting reproductive medicine[84](index=84&type=chunk) - FemBloc pivotal FINALE trial: FDA IDE approval received in **June 2023**, and enrollment initiated in **August 2023**[86](index=86&type=chunk) - FemBloc trial design: Prospective, multi-center, open-label, single-arm study with pregnancy rate as the primary endpoint, targeting **401** women for one year of use, with an interim analysis planned after **300** women[86](index=86&type=chunk) - A new U.S. patent for FemBloc, expected to expire in **2039**, received a notice of allowance in **July 2023**[86](index=86&type=chunk) [Results of Operations - Three Months Ended June 30, 2023 and 2022](index=18&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030%2C%202023%20and%202022) Compares the company's financial performance, including sales, expenses, and net loss, for the three months ended June 30 Financial Performance (Three Months Ended June 30) | Metric | 2023 | 2022 | Change | % Change | |---|---|---|---|---| | Sales | $320,514 | $303,113 | $17,401 | 5.7% | | Cost of sales | $110,469 | $102,353 | $8,116 | 7.9% | | Gross margin | $210,045 | $200,760 | $9,285 | 4.6% | | Total operating expenses | $3,146,007 | $2,860,723 | $285,284 | 10.0% | | Net loss | $(2,893,508) | $(2,634,101) | $(259,407) | 9.8% | - Sales increase was primarily due to **$58,045** in international sales in 2023, with no international sales in the prior year, while U.S. sales decreased by **13.4%**[87](index=87&type=chunk) - Sales and marketing expenses more than doubled, increasing by **104%** to **$128,899**, reflecting increased commercial efforts[90](index=90&type=chunk) - Research and development expenses increased by **3.7%** to **$1,527,172**, mainly due to higher compensation and professional costs[89](index=89&type=chunk) [Results of Operations - Six Months Ended June 30, 2023 and 2022](index=19&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030%2C%202023%20and%202022) Compares the company's financial performance, including sales, expenses, and net loss, for the six months ended June 30 Financial Performance (Six Months Ended June 30) | Metric | 2023 | 2022 | Change | % Change | |---|---|---|---|---| | Sales | $614,498 | $624,518 | $(10,020) | -1.6% | | Cost of sales | $215,589 | $225,028 | $(9,439) | -4.2% | | Gross margin | $398,909 | $399,490 | $(581) | -0.1% | | Total operating expenses | $6,376,545 | $5,942,203 | $434,342 | 7.3% | | Net loss | $(5,839,765) | $(5,517,131) | $(322,634) | 5.8% | - Sales decrease was entirely attributable to U.S. sales, with international sales remaining consistent[95](index=95&type=chunk) - Gross margin percentage improved to **64.9%** from **64.0%** due to manufacturing efficiencies[96](index=96&type=chunk) - Sales and marketing expenses surged by **183.1%** to **$373,795**, primarily due to increased compensation and marketing costs[98](index=98&type=chunk) - Interest income increased significantly by **378.6%** to **$139,741**[101](index=101&type=chunk) [Liquidity and Capital Resources](index=21&type=section&id=Liquidity%20and%20Capital%20Resources) Assesses the company's cash position, funding needs, and ability to continue as a going concern - As of **June 30, 2023**, the company had **$10,705,017** in cash and cash equivalents and an accumulated deficit of **$99,974,270**[103](index=103&type=chunk) - Existing cash and net proceeds from the **April 2023** financing (**$3,352,049**) are expected to fund operations into the **second quarter of 2024**[105](index=105&type=chunk)[106](index=106&type=chunk) - Substantial doubt exists about the company's ability to continue as a going concern for at least **twelve months** from the financial statement date[106](index=106&type=chunk) - Additional capital is required to complete development and commercialization of product candidates, with no assurance of securing funds on acceptable terms[107](index=107&type=chunk) [Cash Flows](index=21&type=section&id=Cash%20Flows) Analyzes cash flows from operating, investing, and financing activities for the six months ended June 30 Cash Flow Summary (Six Months Ended June 30) | Activity | 2023 | 2022 | |---|---|---| | Net cash used in operating activities | $(5,388,824) | $(5,133,896) | | Net cash used in investing activities | $(71,849) | $(295,058) | | Net cash provided by (used in) financing activities | $3,203,754 | $(237,656) | | Net change in cash and cash equivalents | $(2,256,919) | $(5,666,610) | - Operating activities used **$5,388,824** in cash, mainly due to the net loss, partially offset by non-cash charges like depreciation and stock-based compensation[109](index=109&type=chunk) - Financing activities provided **$3,203,754**, primarily from the issuance of common stock and warrants (**$3,905,071**), offset by offering costs and note repayments[113](index=113&type=chunk) - Investing activities used **$71,849** for property and equipment purchases, a decrease from **$295,058** in the prior year[111](index=111&type=chunk)[112](index=112&type=chunk) [Critical Accounting Estimates](index=22&type=section&id=Critical%20Accounting%20Estimates) Explains key accounting policies and estimates, particularly for revenue recognition and accrued expenses - Revenue recognition policy: Revenue is recognized when a customer obtains control of promised goods, typically upon shipment, with no multiple performance obligations or revenue recognized over time[117](index=117&type=chunk) - Accrued expenses policy: Estimates are made for R&D activities conducted by third-party service providers, recording costs based on estimated services provided but not yet invoiced, which can be a significant component of R&D expenses[119](index=119&type=chunk) - Estimates are based on historical experience and other reasonable factors, but actual results may differ materially[115](index=115&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=22&type=section&id=Item%203%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states that there are no applicable quantitative and qualitative disclosures about market risk for Femasys Inc. for the reported period - The company has no applicable quantitative and qualitative disclosures about market risk[120](index=120&type=chunk) [Item 4. Controls and Procedures](index=22&type=section&id=Item%204%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the effectiveness of Femasys Inc.'s disclosure controls and procedures as of June 30, 2023, concluding they were effective at a reasonable assurance level. No material changes in internal control over financial reporting were identified, though inherent limitations on control effectiveness are acknowledged - Disclosure controls and procedures were evaluated and deemed effective at a reasonable assurance level as of **June 30, 2023**[121](index=121&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter ended **June 30, 2023**[122](index=122&type=chunk) - Management acknowledges inherent limitations of control systems, stating they provide only reasonable, not absolute, assurance against errors and fraud[123](index=123&type=chunk) [Part II. Other Information](index=23&type=section&id=Part%20II.%20Other%20Information) This part contains additional information not covered in the financial statements, including legal proceedings and risk factors [Item 1. Legal Proceedings](index=23&type=section&id=Item%201%20Legal%20Proceedings) Femasys Inc. may be involved in legal proceedings but believes that the amount of reasonably possible losses in excess of established reserves is not material to its consolidated financial condition or cash flows, although such losses could be material to operating results for a specific future period - The company believes that reasonably possible losses from pending legal actions, in excess of reserves, are not material to its consolidated financial condition or cash flows[125](index=125&type=chunk) - Losses from legal proceedings could be material to operating results for any particular future period[125](index=125&type=chunk) [Item 1A. Risk Factors](index=23&type=section&id=Item%201A%20Risk%20Factors) This section refers readers to the comprehensive risk factors detailed in the company's Annual Report on Form 10-K. A new risk factor highlights Femasys Inc.'s non-compliance with Nasdaq's minimum bid price requirement, which could lead to delisting and negatively impact stock liquidity and future capital raising abilities - Readers are directed to the Annual Report on Form 10-K for a comprehensive review of risk factors[126](index=126&type=chunk) - The company received a deficiency letter from Nasdaq on **June 1, 2023**, for non-compliance with the Minimum Bid Price Requirement (**$1.00** per share)[127](index=127&type=chunk) - Femasys has until **November 28, 2023**, to regain compliance, potentially through a reverse stock split, or face delisting, which could reduce stock liquidity and harm capital raising[127](index=127&type=chunk)[128](index=128&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=23&type=section&id=Item%202%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section states that there were no unregistered sales of equity securities or use of proceeds to report for Femasys Inc. during the period - No unregistered sales of equity securities or use of proceeds to report[129](index=129&type=chunk) [Item 3. Defaults Upon Senior Securities](index=24&type=section&id=Item%203%20Defaults%20Upon%20Senior%20Securities) This section indicates that Femasys Inc. has no defaults upon senior securities to report for the period - No defaults upon senior securities to report[131](index=131&type=chunk) [Item 4. Mine Safety Disclosures](index=24&type=section&id=Item%204%20Mine%20Safety%20Disclosures) This section states that mine safety disclosures are not applicable to Femasys Inc - Mine safety disclosures are not applicable[132](index=132&type=chunk) [Item 5. Other Information](index=24&type=section&id=Item%205%20Other%20Information) This section indicates that there is no other information to report for Femasys Inc. for the period - No other information to report[133](index=133&type=chunk) [Item 6. Exhibits](index=24&type=section&id=Item%206%20Exhibits) This section lists all exhibits filed as part of Femasys Inc.'s Form 10-Q, including various warrants, a securities purchase agreement, and certifications from the principal executive and financial officers, providing supporting documentation for the report - Exhibits include Pre-Funded Common Stock Purchase Warrant, Common Stock Purchase Warrant, Placement Agent Common Stock Purchase Warrant, and Securities Purchase Agreement dated **April 18, 2023**[134](index=134&type=chunk) - Certifications from the Principal Executive Officer and Principal Financial Officer pursuant to Sarbanes-Oxley Act are filed herewith[134](index=134&type=chunk) [Signatures](index=25&type=section&id=SIGNATURES) Confirms the official signing of the Form 10-Q report by the company's principal executive and financial officers - The report is signed by Kathy Lee-Sepsick, Chief Executive Officer and President, and Dov Elefant, Chief Financial Officer, on **August 10, 2023**[135](index=135&type=chunk)[137](index=137&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________to____________ Commission file number: 001-40492 Femasys Inc. Washington, D.C. 20549 FORM 10-Q Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☑ Smaller report ...

[Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section outlines that the Annual Report on Form 10-K contains forward-looking statements, subject to risks and uncertainties, and the company does not plan to update them [Special Note Regarding Forward-Looking Statements](index=3&type=section&id=Special%20Note%20Regarding%20Forward-Looking%20Statements) The Annual Report on Form 10-K includes forward-looking statements based on current expectations, which are subject to risks and uncertainties, and actual results may differ materially - The report contains forward-looking statements, which are predictions based on current expectations and projections about future events and financial trends[12](index=12&type=chunk)[14](index=14&type=chunk) - These statements are subject to known and unknown risks, uncertainties, and assumptions, including those described under 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operations'[14](index=14&type=chunk) - Actual results could differ materially from those projected, and the company does not plan to publicly update or revise any forward-looking statements, which are excluded from safe harbor protection[14](index=14&type=chunk) [PART I](index=7&type=section&id=PART%20I) This part provides a comprehensive overview of Femasys Inc.'s business, including its product candidates, strategy, market landscape, intellectual property, regulatory environment, and associated risks [Item 1. Business](index=7&type=section&id=Item%201.%20Business) Femasys Inc. is a biomedical company focused on transforming women's healthcare through novel, minimally-invasive, non-surgical product technologies, with lead candidates FemBloc and FemaSeed - Femasys Inc. is a biomedical company dedicated to transforming women's healthcare with minimally-invasive, non-surgical product technologies[21](index=21&type=chunk) - The company's lead product candidates are FemBloc for permanent birth control and FemaSeed for artificial insemination, addressing multi-billion dollar global market segments[21](index=21&type=chunk) - Femasys possesses an expansive, internally created intellectual property portfolio with **over 150 global patents** and in-house manufacturing capabilities[21](index=21&type=chunk)[31](index=31&type=chunk)[32](index=32&type=chunk) [Business Overview](index=7&type=section&id=Business%20Overview) Femasys is a woman-founded biomedical company developing minimally-invasive, non-surgical solutions for women's reproductive health, including FemBloc for permanent birth control and FemaSeed for artificial insemination - Femasys is a woman-founded and led biomedical company focused on minimally-invasive, non-surgical solutions for women's healthcare[21](index=21&type=chunk) - FemBloc is a permanent birth control solution in development, designed as the first non-surgical, non-implant option, using a degradable biopolymer to close fallopian tubes in a physician's office[22](index=22&type=chunk) - FemaSeed is an artificial insemination solution in development, offering selective delivery of sperm directly to the fallopian tube, aiming to be a first-line treatment for infertility, especially male factor infertility[26](index=26&type=chunk) [Our Team](index=9&type=section&id=Our%20Team) Femasys is led by an experienced team of biotechnology and medical device developers who have raised over $100 million since inception to advance women's health - Femasys is a woman-founded, woman-led biomedical company with an experienced leadership team[30](index=30&type=chunk) - The team has raised **over $100 million** since inception from institutional and strategic investors, including Medtronic and an IPO in June 2021[30](index=30&type=chunk) [Our Intellectual Property and Production Capabilities](index=9&type=section&id=Our%20Intellectual%20Property%20and%20Production%20Capabilities) Femasys protects its women's health solutions with a robust intellectual property portfolio of 40 U.S. and 122 foreign patents and maintains in-house manufacturing capabilities compliant with FDA and ISO standards - Femasys protects its proprietary methods with patents, know-how, and trade secrets[31](index=31&type=chunk) Intellectual Property Portfolio (as of December 31, 2022) | Category | Number | | :--------------------------------- | :----- | | Issued U.S. Patents | 40 | | Issued Foreign Patents | 122 | | Pending U.S. Patent Applications | 13 | | Pending Foreign Patent Applications | 17 | | Expected Expiration (without extensions) | 2023-2046 | - All products are manufactured or assembled at the company's facility, ensuring compliance with FDA and good manufacturing practices (QSR) and ISO 13485:2016[32](index=32&type=chunk)[63](index=63&type=chunk) [Our Strategy](index=9&type=section&id=Our%20Strategy) Femasys aims to be a global leader in women's health by addressing unmet clinical needs, executing clinical programs for FDA approvals, continuously innovating, and building a specialized sales and marketing team - Strategy includes addressing unmet clinical needs in large women's health markets, particularly reproductive health (permanent birth control and infertility)[33](index=33&type=chunk)[34](index=34&type=chunk) - Execute clinical programs to achieve FDA approval for FemBloc (PMA) and de novo classification for FemaSeed, with submissions planned for **Q1 2023** and **Q2 2023**, respectively[35](index=35&type=chunk)[36](index=36&type=chunk) - Continuously innovate and introduce additional women-specific medical products, such as the recently introduced FemCerv and the developing FemEMB, and build a specialized direct sales and marketing team[38](index=38&type=chunk)[40](index=40&type=chunk) [The Current Market Landscape](index=10&type=section&id=The%20Current%20Market%20Landscape) The current markets for permanent birth control and artificial insemination are characterized by invasive, costly, or low-efficacy options, which Femasys aims to disrupt with its non-surgical and localized solutions - Existing permanent birth control options are surgical tubal ligation (invasive, risks) or temporary methods (hormonal, implants, health risks)[42](index=42&type=chunk) - Current artificial insemination options include IUI (low success rate, undirected) and IVF/ICSI (high cost, invasive, physical/emotional demands)[44](index=44&type=chunk) - Femasys's FemBloc aims to be the first non-surgical, non-implant permanent birth control, and FemaSeed aims to be the first localized, directional sperm delivery for artificial insemination[42](index=42&type=chunk)[44](index=44&type=chunk) [The Reproductive Health Opportunity](index=11&type=section&id=The%20Reproductive%20Health%20Opportunity) Femasys targets a multi-billion dollar reproductive health market where many women seek to prevent or achieve pregnancy but are dissatisfied with existing options due to invasiveness, cost, or limited success - The U.S. market for permanent birth control could exceed **$20 billion** with a safe and effective in-office option, as **12 million women** use non-permanent methods[46](index=46&type=chunk) - The U.S. market for assisted reproduction could exceed **$2 billion** with a novel first-line approach, addressing **over 10 million infertile women**[47](index=47&type=chunk) - Current options for permanent birth control (surgical) and infertility (IUI, IVF) have limitations in terms of invasiveness, cost, and success rates, creating significant unmet needs[46](index=46&type=chunk)[47](index=47&type=chunk) [Clinical Development](index=12&type=section&id=Clinical%20Development) Femasys is actively developing clinical evidence for FemBloc and FemaSeed, with preclinical studies showing efficacy and clinical trials progressing despite past challenges, while FemCerv has demonstrated high adequacy rates - FemBloc preclinical studies demonstrated **0% fertility rate** in treated animals and complete tissue occlusion over time[50](index=50&type=chunk) - FemBloc clinical trials in **228 subjects** reported no serious adverse events, with **91% of events** being mild and occurring within seven days of the procedure[52](index=52&type=chunk) - The FemaSeed pivotal trial, focusing on male factor infertility, is expected to complete enrollment in **Q2 2023**, with results to support a de novo classification request[26](index=26&type=chunk)[61](index=61&type=chunk) - FemCerv, an FDA-cleared endocervical tissue sampler, showed **94% sample adequacy** and **95% mild or no discomfort** in a post-market study[62](index=62&type=chunk) [Manufacturing](index=15&type=section&id=Manufacturing) Femasys manufactures all products in-house under strict quality standards, with sufficient capacity for current needs, while managing supply chain risks from limited third-party suppliers - All products and product candidates are manufactured or assembled in-house, adhering to FDA QSR, MDSAP, and ISO 13485:2016 standards[63](index=63&type=chunk)[66](index=66&type=chunk) - The company has sufficient manufacturing capacity for current clinical and preliminary FemaSeed launch demands, with plans to scale up and consider outsourcing sub-assemblies for commercial growth[63](index=63&type=chunk) - Femasys relies on a limited number of third-party suppliers for components and contract sterilizers, managing supply chain risk through supplier management programs and inventory[67](index=67&type=chunk)[68](index=68&type=chunk)[69](index=69&type=chunk) [Competition](index=16&type=section&id=Competition) Femasys operates in a highly competitive biomedical industry, with FemBloc and FemaSeed having no direct non-surgical or localized delivery competitors, but facing competition from established methods and companies with greater resources - The biomedical industry is highly competitive with rapid technological change[70](index=70&type=chunk) - FemBloc (permanent birth control) has no direct non-surgical, non-implant competitors, but competes with surgical tubal ligation, vasectomies, and temporary birth control methods[71](index=71&type=chunk) - FemaSeed (artificial insemination) has no direct localized directional delivery competitors but competes with IUI, IVF/ICSI, and fertility-enhancing pharmaceuticals[72](index=72&type=chunk) - Many competitors possess greater resources, longer operating histories, and more established products[74](index=74&type=chunk) [Sales & Marketing](index=17&type=section&id=Sales%20%26%20Marketing) Femasys plans to build direct sales forces in the U.S. for FemaSeed and FemBloc, targeting specialists and gynecologists, with minimal training requirements and awareness campaigns for product benefits - Femasys plans to recruit and train a direct sales force for FemaSeed in the U.S., targeting approximately **1,300 reproductive endocrinologists** at **450 practices**, prioritizing existing FemVue customers and high-volume states[75](index=75&type=chunk)[76](index=76&type=chunk) - For FemBloc, if approved, a gynecologist-focused sales force will target approximately **41,000 gynecologists**, prioritizing **13 states** with high reproductive-aged women populations[78](index=78&type=chunk) - Physicians experienced in intrauterine procedures will require minimal training for FemBloc and FemaSeed, with additional sonographic training for confirmation tests expected to be largely online[79](index=79&type=chunk) [Reimbursement](index=17&type=section&id=Reimbursement) Femasys anticipates revenue from FemaSeed and FemBloc sales through established CPT codes and third-party payors, with FemBloc expected to be covered under the Affordable Care Act - FemaSeed revenue is expected from fertility practices billing patients or third-party payors, utilizing established CPT codes for intrauterine insemination[81](index=81&type=chunk) - FemBloc revenue is expected from gynecology offices billing third-party payors, currently using CPT Category III codes, with plans to seek Category I codes requiring clinical efficacy documentation[83](index=83&type=chunk)[84](index=84&type=chunk) - The FemBloc procedure is expected to map to APC level 4 gynecologic procedures with a payment of **$2,498** (tubal ligation) and is anticipated to be covered under the Affordable Care Act (ACA)[84](index=84&type=chunk)[85](index=85&type=chunk) [Intellectual Property](index=18&type=section&id=Intellectual%20Property) Femasys protects its proprietary technology through a portfolio of 40 U.S. and 122 foreign patents, trademarks, and trade secrets, with specific patent families covering key products - Femasys protects its proprietary technology through patents, trademarks, trade secrets, and other intellectual property rights[87](index=87&type=chunk) Intellectual Property Portfolio (as of December 31, 2022) | Category | Number | | :--------------------------------- | :----- | | Issued U.S. Patents | 40 | | Issued Foreign Patents | 122 | | Pending U.S. Patent Applications | 13 | | Pending Foreign Patent Applications | 17 | | Expected Expiration (without extensions) | 2023-2046 | - Specific patent families cover key products like FemBloc (protection until at least **2025/2030**), FemVue (**2026/2028**), FemChec (**2026/2028/2029/2032**), FemaSeed (**2025/2026**), FemCerv (**2027/2032/2033**), and FemEMB (**2033**)[91](index=91&type=chunk) [Government Regulation](index=19&type=section&id=Government%20Regulation) Femasys's medical devices are subject to extensive U.S. and international regulations covering all stages from design to post-market surveillance, along with healthcare fraud, abuse, and data privacy laws, with non-compliance carrying substantial penalties - Medical devices are subject to extensive regulation by the FDA in the U.S. and international authorities, covering all stages from design to post-market surveillance[93](index=93&type=chunk) - U.S. pre-market review pathways include 510(k) clearance (Class I/II), de novo classification (novel low/moderate risk Class III to Class I/II), and Pre-market Approval (PMA) (Class III, highest risk)[94](index=94&type=chunk)[96](index=96&type=chunk)[98](index=98&type=chunk)[101](index=101&type=chunk) - Ongoing regulations include Quality System Regulation (QSR), labeling, promotion restrictions, and medical device reporting (MDR) for adverse events[110](index=110&type=chunk)[112](index=112&type=chunk)[113](index=113&type=chunk)[114](index=114&type=chunk) - The company is subject to federal and state healthcare fraud and abuse laws (Anti-Kickback, False Claims, HIPAA, Sunshine Act) and patient data privacy laws (HIPAA, HITECH, CCPA, GDPR), with non-compliance carrying significant civil and criminal penalties[123](index=123&type=chunk)[124](index=124&type=chunk)[125](index=125&type=chunk)[126](index=126&type=chunk)[128](index=128&type=chunk)[129](index=129&type=chunk)[130](index=130&type=chunk)[131](index=131&type=chunk)[132](index=132&type=chunk)[288](index=288&type=chunk)[291](index=291&type=chunk)[292](index=292&type=chunk)[297](index=297&type=chunk)[298](index=298&type=chunk)[299](index=299&type=chunk)[300](index=300&type=chunk)[301](index=301&type=chunk) - The Affordable Care Act (ACA) and other healthcare reform measures in the U.S. and EU (Medical Devices Regulation) impact the healthcare industry, potentially affecting reimbursement and regulatory requirements[134](index=134&type=chunk)[135](index=135&type=chunk)[136](index=136&type=chunk)[137](index=137&type=chunk)[138](index=138&type=chunk)[139](index=139&type=chunk)[285](index=285&type=chunk)[286](index=286&type=chunk)[287](index=287&type=chunk)[302](index=302&type=chunk)[303](index=303&type=chunk)[304](index=304&type=chunk)[305](index=305&type=chunk)[306](index=306&type=chunk)[307](index=307&type=chunk) [Employees and Human Capital Resources](index=26&type=section&id=Employees%20and%20Human%20Capital%20Resources) Femasys employs 34 full-time and two part-time individuals, focusing on attracting and retaining diverse talent through competitive compensation and an inclusive environment to support business objectives Employee Count (as of December 31, 2022) | Category | Number | | :--------- | :----- | | Full-time employees | 34 | | Part-time employees | 2 | | Consultants | 18 | - The company focuses on attracting, motivating, and retaining highly qualified and diverse talent through competitive compensation, benefits, and an inclusive environment[141](index=141&type=chunk)[142](index=142&type=chunk)[144](index=144&type=chunk) [Facilities](index=27&type=section&id=Facilities) Femasys operates all its research, development, manufacturing, and office activities from a single 45,000 square foot facility in Suwanee, Georgia - Femasys operates from a single **45,000 square foot** facility in Suwanee, Georgia, housing research, development, manufacturing, and office space[145](index=145&type=chunk) [Legal Proceedings](index=27&type=section&id=Legal%20Proceedings) Femasys is not currently involved in any material legal proceedings, but may face future litigation related to intellectual property, which could incur costs and divert management attention - Femasys is not currently a party to any legal proceedings expected to have a material adverse effect on its business[146](index=146&type=chunk) - The company may receive allegations of patent or trademark infringement and may participate in litigation, which could divert management time and incur financial costs[146](index=146&type=chunk) [About Us and Available Information](index=27&type=section&id=About%20Us%20and%20Available%20Information) Femasys Inc., incorporated in Delaware in 2004 and headquartered in Suwanee, Georgia, files its public reports with the SEC, which are accessible on the SEC's and the company's websites - Femasys Inc. was incorporated in Delaware on **February 19, 2004**, and is headquartered in Suwanee, Georgia[147](index=147&type=chunk) - The company files reports with the SEC, available on www.sec.gov and its website www.femasys.com, including 10-K, 10-Q, 8-K, and corporate governance documents[147](index=147&type=chunk)[148](index=148&type=chunk) [Item 1A. Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors) Investing in Femasys common stock involves high risk due to significant operating losses, the need for additional funding, potential clinical and regulatory failures, intense competition, and challenges in managing growth and intellectual property - Femasys has incurred significant operating losses since inception and expects to continue incurring losses, with an accumulated deficit of **$94,134,505** as of December 31, 2022[150](index=150&type=chunk)[151](index=151&type=chunk) - There is substantial doubt about the company's ability to continue as a going concern, as current cash and cash equivalents are expected to fund operations only into **Q1 2024**, necessitating additional funding[151](index=151&type=chunk)[155](index=155&type=chunk)[160](index=160&type=chunk) - Key risks include delays or failures in clinical trials (e.g., FemBloc, FemaSeed), inability to obtain FDA approvals or market acceptance, intense competition, and challenges in managing organizational growth[165](index=165&type=chunk)[170](index=170&type=chunk)[171](index=171&type=chunk)[174](index=174&type=chunk)[175](index=175&type=chunk)[188](index=188&type=chunk)[190](index=190&type=chunk)[193](index=193&type=chunk)[203](index=203&type=chunk)[244](index=244&type=chunk) - The company faces risks related to intellectual property protection, compliance with extensive government regulations (FDA, healthcare fraud, privacy), and adverse global economic conditions[248](index=248&type=chunk)[249](index=249&type=chunk)[288](index=288&type=chunk)[297](index=297&type=chunk)[314](index=314&type=chunk)[315](index=315&type=chunk)[362](index=362&type=chunk) [Risks Related to Our Financial Position and Need for Additional Capital](index=27&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) Femasys has incurred significant operating losses and an accumulated deficit, requiring substantial additional funding to continue operations beyond Q1 2024, raising substantial doubt about its going concern ability Financial Performance and Position (2021-2022) | Metric | 2022 | 2021 | | :----------------------- | :----------- | :----------- | | Net Loss | $(11,394,170) | $(7,537,845) | | Accumulated Deficit (as of Dec 31) | $(94,134,505) | $(82,740,335) | | Cash & Cash Equivalents (as of Dec 31) | $12,961,936 | $24,783,029 | - Current cash and cash equivalents are expected to fund operations only into **Q1 2024**, indicating a need for substantial additional funding and raising substantial doubt about the company's ability to continue as a going concern[151](index=151&type=chunk)[155](index=155&type=chunk)[160](index=160&type=chunk)[431](index=431&type=chunk) - Future funding requirements are dependent on factors such as clinical trial progress, regulatory approvals, market acceptance, and intellectual property costs[158](index=158&type=chunk)[434](index=434&type=chunk) - The company's ability to use net operating losses (NOLs) and R&D credit carryforwards to offset future taxable income may be limited due to past or future ownership changes under Sections 382 and 383 of the Internal Revenue Code[163](index=163&type=chunk)[573](index=573&type=chunk)[576](index=576&type=chunk) [Risks Related to Discovery and Development](index=30&type=section&id=Risks%20Related%20to%20Discovery%20and%20Development) Femasys faces significant risks in product development, including clinical trial delays, potential FDA non-approval for FemBloc, lengthy and uncertain regulatory processes, and intense competition from better-resourced companies - Enrollment and retention in clinical trials are expensive and time-consuming, potentially delayed by factors like the COVID-19 pandemic and consolidation in the infertility market, which may affect IVF access[165](index=165&type=chunk)[166](index=166&type=chunk)[167](index=167&type=chunk)[169](index=169&type=chunk) - The FDA may not allow a pivotal trial for FemBloc PMA approval due to past unintended pregnancies caused by ultrasound misinterpretation, despite a validation study showing no pregnancies with dual confirmation[170](index=170&type=chunk) - Obtaining FDA approval (PMA for FemBloc) or de novo classification (FemaSeed) is lengthy, expensive, and uncertain, with no guarantee of success or broad market acceptance[171](index=171&type=chunk)[175](index=175&type=chunk)[177](index=177&type=chunk)[188](index=188&type=chunk)[190](index=190&type=chunk)[193](index=193&type=chunk) - The company faces intense competition from established biomedical companies with greater resources and must continuously enhance its products and expand indications for long-term growth[203](index=203&type=chunk)[204](index=204&type=chunk)[207](index=207&type=chunk) - Inaccurate forecasting of customer demand and inventory management could materially harm operations, and reliance on a limited number of third-party suppliers and sterilizers poses supply chain risks[208](index=208&type=chunk)[209](index=209&type=chunk)[212](index=212&type=chunk)[213](index=213&type=chunk)[216](index=216&type=chunk)[217](index=217&type=chunk) [Risks Related to Managing Growth and Employee Matters](index=41&type=section&id=Risks%20Related%20to%20Managing%20Growth%20and%20Employee%20Matters) Femasys faces risks from health epidemics, IT system vulnerabilities, reliance on a single facility, challenges in attracting and retaining talent, and the complexities of managing organizational expansion and social media use - Health epidemics, such as the COVID-19 pandemic, can significantly disrupt clinical trials, delay regulatory approvals, and adversely affect business operations and financial condition[235](index=235&type=chunk)[237](index=237&type=chunk)[401](index=401&type=chunk) - Reliance on information technology systems makes the company vulnerable to failures, security breaches, or unauthorized access, potentially leading to operational interruptions, liabilities, and reputational harm[239](index=239&type=chunk)[240](index=240&type=chunk)[364](index=364&type=chunk)[365](index=365&type=chunk)[366](index=366&type=chunk) - The company's single facility in Suwanee, Georgia, creates a risk of business disruption if damaged or rendered inoperable by disasters[241](index=241&type=chunk) - Maintaining a competitive position depends on attracting and retaining highly qualified senior management and other personnel, with replacement involving significant time and costs[242](index=242&type=chunk) - Future growth will require expanding the organization, which may be difficult to manage effectively, and increasing reliance on independent organizations and consultants[244](index=244&type=chunk)[245](index=245&type=chunk)[246](index=246&type=chunk) - The increasing use of social media platforms presents new risks and challenges related to regulatory compliance, potential for off-label marketing allegations, and reputational harm[247](index=247&type=chunk) [Risks Related to Government Regulation](index=43&type=section&id=Risks%20Related%20to%20Government%20Regulation) Femasys's products are subject to extensive U.S. and international government regulations, including marketing authorizations, manufacturing standards, and fraud and abuse laws, with non-compliance leading to severe penalties and business disruption - Femasys's products and operations are subject to extensive and stringent government regulation by the FDA and foreign counterparts, with non-compliance leading to severe enforcement actions[248](index=248&type=chunk)[249](index=249&type=chunk)[251](index=251&type=chunk) - Failure to obtain necessary marketing authorizations (PMA for FemBloc, de novo for FemaSeed, 510(k) for others) or timely approval for modifications could adversely affect business growth[252](index=252&type=chunk)[253](index=253&type=chunk)[254](index=254&type=chunk)[255](index=255&type=chunk)[263](index=263&type=chunk)[264](index=264&type=chunk) - Post-marketing regulatory requirements, including periodic reports and compliance with PMA conditions, are ongoing, and non-compliance could lead to enforcement actions or product withdrawal[265](index=265&type=chunk)[266](index=266&type=chunk)[267](index=267&type=chunk) - Products must be manufactured in accordance with federal and state Quality System Regulations (QSR), and failure to comply could result in recalls or production termination[270](index=270&type=chunk)[271](index=271&type=chunk) - The company is subject to federal, state, and foreign fraud and abuse laws (Anti-Kickback, False Claims, HIPAA, Sunshine Act) and health information privacy and security laws (HIPAA, HITECH, GDPR, CCPA), with violations leading to substantial penalties and reputational harm[288](index=288&type=chunk)[291](index=291&type=chunk)[292](index=292&type=chunk)[297](index=297&type=chunk)[300](index=300&type=chunk)[301](index=301&type=chunk) - Inadequate funding for regulatory agencies (FDA, SEC) or changes in healthcare policies (e.g., ACA) could delay product reviews, increase costs, or reduce demand[294](index=294&type=chunk)[295](index=295&type=chunk)[302](index=302&type=chunk)[303](index=303&type=chunk)[304](index=304&type=chunk)[305](index=305&type=chunk)[306](index=306&type=chunk)[307](index=307&type=chunk)[308](index=308&type=chunk) [Risks Related to Intellectual Property Matters](index=55&type=section&id=Risks%20Related%20to%20Intellectual%20Property%20Matters) Femasys's competitive position depends on protecting its intellectual property, but patents may be challenged or circumvented, and litigation or misuse of confidential information could incur significant costs and harm the business - Commercial success depends on obtaining, maintaining, protecting, and enforcing intellectual property rights, including patents, trademarks, and trade secrets[314](index=314&type=chunk)[315](index=315&type=chunk) - Patents may be challenged, deemed unenforceable, invalidated, or circumvented, and may not provide adequate protection against competitors[317](index=317&type=chunk)[318](index=318&type=chunk)[320](index=320&type=chunk) - Litigation or third-party claims of intellectual property infringement are costly, time-consuming, and could lead to substantial damages, royalties, or the need to redesign products[324](index=324&type=chunk)[326](index=326&type=chunk) - Obtaining and maintaining patent protection requires compliance with governmental requirements, and recent changes in U.S. patent laws (Leahy-Smith Act) could increase uncertainties and costs[323](index=323&type=chunk)[334](index=334&type=chunk)[335](index=335&type=chunk) - Inadequate protection of trademarks and trade names could hinder brand recognition, and the company faces risks from employees or consultants misusing confidential information or misappropriating trade secrets[322](index=322&type=chunk)[328](index=328&type=chunk)[329](index=329&type=chunk)[337](index=337&type=chunk)[339](index=339&type=chunk) [Risks Related to Our Common Stock](index=59&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) Femasys's common stock faces risks from reduced disclosure requirements as an emerging growth company, anti-takeover provisions, significant insider voting power, public company costs, and the absence of anticipated cash dividends - As a "smaller reporting company" and "emerging growth company," Femasys benefits from reduced disclosure requirements, which may make its common stock less attractive to investors[340](index=340&type=chunk)[341](index=341&type=chunk)[342](index=342&type=chunk)[343](index=343&type=chunk) - Anti-takeover provisions in charter documents and Delaware law could make an acquisition more difficult and prevent attempts by stockholders to replace management[343](index=343&type=chunk)[345](index=345&type=chunk) - Officers, directors, and principal stockholders collectively control approximately **18.7%** of outstanding common stock, potentially influencing matters requiring stockholder approval[346](index=346&type=chunk) - The company incurs significant costs as a public company and is obligated to develop and maintain effective internal controls over financial reporting, with potential adverse effects on investor confidence if controls are inadequate[347](index=347&type=chunk)[348](index=348&type=chunk)[350](index=350&type=chunk)[351](index=351&type=chunk) - The amended and restated certificate of incorporation designates Delaware courts as the exclusive forum for certain disputes, potentially limiting stockholders' choice of judicial forum[352](index=352&type=chunk)[353](index=353&type=chunk) - Femasys does not anticipate paying cash dividends in the foreseeable future, making capital appreciation the sole source of gain for stockholders[354](index=354&type=chunk) [General Risk Factors](index=62&type=section&id=General%20Risk%20Factors) Femasys faces general risks including adverse financial industry developments, unfavorable global economic conditions, cybersecurity threats, inaccurate market forecasts, employee misconduct, and stock price volatility - Adverse developments in the financial services industry, including bank failures (e.g., SVB), could significantly impair access to cash and liquidity, impacting business operations and financial condition[356](index=356&type=chunk)[357](index=357&type=chunk)[359](index=359&type=chunk)[360](index=360&type=chunk) - Unfavorable global economic conditions can adversely affect demand for products and the ability to raise additional capital[362](index=362&type=chunk) - Internal computer systems are vulnerable to cybersecurity attacks and data breaches, potentially leading to operational disruptions, significant liabilities, and reputational harm[364](index=364&type=chunk)[365](index=365&type=chunk)[366](index=366&type=chunk) - Estimates of market opportunity and growth forecasts may prove inaccurate, and the business may not grow as projected[368](index=368&type=chunk) - Misconduct by employees, contractors, or partners, including noncompliance with regulatory standards, could lead to penalties, investigations, and reputational damage[369](index=369&type=chunk) - The trading market for common stock may not be sustained, and its price is expected to fluctuate substantially due to various factors, including regulatory approvals, clinical trial results, and market conditions[371](index=371&type=chunk)[372](index=372&type=chunk) [Item 1B. Unresolved Staff Comments](index=65&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) There are no unresolved staff comments from the SEC regarding the company's filings - No unresolved staff comments were reported[377](index=377&type=chunk) [Item 2. Properties](index=65&type=section&id=Item%202.%20Properties) Femasys leases a 45,000 square foot facility in Suwanee, Georgia, for R&D, manufacturing, and office space, with the current lease expiring in January 2024 and an extension process initiated - Femasys leases a **45,000 square foot** facility in Suwanee, Georgia, for R&D, manufacturing, and office space[378](index=378&type=chunk) - The lease expires in **January 2024**, with an option for two consecutive five-year extensions, and the company has provided written notice to exercise this option[378](index=378&type=chunk)[550](index=550&type=chunk) [Item 3. Legal Proceedings](index=65&type=section&id=Item%203.%20Legal%20Proceedings) Femasys is not currently involved in any material legal proceedings - No material legal proceedings were reported[379](index=379&type=chunk) [Item 4. Mine Safety Disclosures](index=65&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to Femasys Inc - This item is not applicable[379](index=379&type=chunk) [PART II](index=66&type=section&id=PART%20II) This part covers Femasys's common stock market, financial condition, results of operations, and critical accounting policies, along with disclosures about market risk and financial statements [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=66&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity,%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Femasys common stock is listed on NASDAQ under FEMY, with 160 record holders as of March 2023, and the company does not anticipate paying cash dividends, intending to retain earnings for business development - Femasys common stock is listed on the NASDAQ Capital Market under the ticker symbol **FEMY**[381](index=381&type=chunk) - As of **March 24, 2023**, there were **160 holders of record** of common stock[382](index=382&type=chunk) - The company has not declared or paid cash dividends and does not anticipate doing so, expecting to retain future earnings for business development[382](index=382&type=chunk) - No material change in the planned use of proceeds from the **June 2021 IPO**[386](index=386&type=chunk) Equity Compensation Plan Information (as of December 31, 2022) | Plan Category | Number of shares to be issued upon exercise of outstanding options () | Weighted average exercise price of outstanding options ($) | Number of shares remaining available for future issuance | | :--------------------------------------- | :------------------------------------------------------- | :------------------------------------------------------- | :------------------------------------------------------- | | Equity compensation plans approved by stockholders (2021 Plan) | 357,950 | $5.40 | 1,605,111 | | Equity compensation plans not approved by stockholders (2015 Plan) | 573,600 | $3.07 | n/a | | Inducement Awards | 150,000 | $2.42 | n/a | | **Total** | **1,081,550** | | **1,605,111** | [Item 6. [Reserved]](index=67&type=section&id=Item%206.%20%5BReserved%5D) This item is reserved and not applicable - This item is reserved and not applicable[391](index=391&type=chunk) [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=67&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Femasys reported a net loss of $11.4 million in 2022, an increase from 2021, driven by higher R&D and sales & marketing expenses, with current cash sufficient only into Q1 2024, raising going concern doubts - Femasys is a biomedical company focused on women's healthcare, with lead product candidates FemBloc (permanent birth control) and FemaSeed (artificial insemination)[391](index=391&type=chunk) - Business operations are significantly affected by clinical trial commencement and conduct, regulatory approvals, clinical results, market acceptance, and competition[400](index=400&type=chunk) - The COVID-19 pandemic has caused delays in clinical trial site initiation and subject enrollment, impacting development timelines[401](index=401&type=chunk) Key Financial Results (Years Ended December 31) | Metric | 2022 | 2021 | Change ($) | Change (%) | | :-------------------------- | :----------- | :----------- | :----------- | :----------- | | Sales | $1,206,218 | $1,179,689 | $26,529 | 2.2% | | Cost of Sales | $441,938 | $370,384 | $71,554 | 19.3% | | Gross Margin | $764,280 | $809,305 | $(45,025) | -5.6% | | Gross Margin Percentage | 63.4% | 68.6% | -5.2% | | | R&D Expenses | $5,813,755 | $4,084,304 | $1,729,451 | 42.3% | | Sales & Marketing Expenses | $558,852 | $208,735 | $350,117 | 167.7% | | General & Administrative Expenses | $5,430,704 | $4,262,002 | $1,168,702 | 27.4% | | Net Loss | $(11,394,170) | $(7,537,845) | $(3,856,325) | 51.2% | | Cash & Cash Equivalents (as of Dec 31) | $12,961,936 | $24,783,029 | $(11,821,093) | -47.7% | - Current cash and cash equivalents are expected to fund operations only into **Q1 2024**, leading to substantial doubt about the company's ability to continue as a going concern and necessitating additional capital[431](index=431&type=chunk)[432](index=432&type=chunk) [Factors Affecting Our Business](index=69&type=section&id=Factors%20Affecting%20Our%20Business) Key factors impacting Femasys's business include the commencement and conduct of clinical trials for product candidates (FemBloc, FemaSeed), timely regulatory approvals, clinical results, market acceptance, and intense competition. The COVID-19 pandemic has further complicated clinical trial enrollment and timelines - Business is impacted by clinical trial progress, regulatory approvals, clinical results, market acceptance, and competition[400](index=400&type=chunk) - The COVID-19 pandemic has caused delays in site initiation and subject enrollment for clinical trials[401](index=401&type=chunk) [Components of Our Comprehensive Loss](index=69&type=section&id=Components%20of%20Our%20Comprehensive%20Loss) Femasys's comprehensive loss components include sales (primarily FemVue), cost of sales, gross margin, and increasing R&D, sales & marketing, and general & administrative expenses as products develop and commercialize - Sales are primarily from the FemVue product, with control transferred upon shipment[402](index=402&type=chunk)[404](index=404&type=chunk) - Cost of sales includes components, materials, labor, and manufacturing overhead, expected to increase with revenue[405](index=405&type=chunk) - R&D expenses, expensed as incurred, include engineering, product development, clinical, and regulatory costs, expected to increase with product candidate development[407](index=407&type=chunk)[408](index=408&type=chunk) - Sales and marketing, and general and administrative expenses are expected to increase in absolute dollars due to commercialization efforts, headcount, and public company costs[409](index=409&type=chunk)[410](index=410&type=chunk) [Results of Operations](index=71&type=section&id=Results%20of%20Operations) In 2022, Femasys's sales increased by 2.2% to $1.21 million, but a 35.2% surge in operating expenses, particularly R&D and sales & marketing, led to a 51.2% increase in net loss to $11.39 million Sales Performance (Years Ended December 31) | Metric | 2022 | 2021 | Change ($) | Change (%) | | :----------------- | :----------- | :----------- | :----------- | :----------- | | Total Sales | $1,206,218 | $1,179,689 | $26,529 | 2.2% | | U.S. Sales | $1,090,359 | $1,005,612 | $84,747 | 8.4% | | International Sales | $115,859 | $174,077 | $(58,218) | -33.4% | Operating Expenses (Years Ended December 31) | Expense Category | 2022 | 2021 | Change ($) | Change (%) | | :-------------------------- | :----------- | :----------- | :----------- | :----------- | | Research and Development | $5,813,755 | $4,084,304 | $1,729,451 | 42.3% | | Sales and Marketing | $558,852 | $208,735 | $350,117 | 167.7% | | General and Administrative | $5,430,704 | $4,262,002 | $1,168,702 | 27.4% | | Total Operating Expenses | $12,364,544 | $9,146,109 | $3,218,435 | 35.2% | - Net loss increased by **51.2%** to **$11,394,170** in 2022, primarily due to higher R&D, sales & marketing, and G&A expenses, partially offset by increased interest income[415](index=415&type=chunk)[423](index=423&type=chunk) [Liquidity and Capital Resources](index=72&type=section&id=Liquidity%20and%20Capital%20Resources) As of December 31, 2022, Femasys had $13.0 million in cash, expected to fund operations only into Q1 2024, raising substantial doubt about its going concern ability and necessitating additional capital Liquidity Snapshot (as of December 31) | Metric | 2022 | 2021 | | :----------------------- | :----------- | :----------- | | Cash and Cash Equivalents | $12,961,936 | $24,783,029 | | Accumulated Deficit | $(94,134,505) | $(82,740,335) | - Current cash and cash equivalents are expected to fund operations only into **Q1 2024**, indicating substantial doubt about the company's ability to continue as a going concern and a need for additional capital[431](index=431&type=chunk)[432](index=432&type=chunk) - Future capital requirements are dependent on the cost and timing of clinical trials, regulatory reviews, sales and marketing capabilities, and intellectual property protection[434](index=434&type=chunk) - In **March 2023**, Femasys transferred substantially all cash from Silicon Valley Bank following its closure, without experiencing losses[430](index=430&type=chunk) [Cash Flows](index=74&type=section&id=Cash%20Flows) In 2022, net cash used in operating activities increased to $10.7 million, while financing activities shifted from a significant inflow in 2021 (IPO) to an outflow, resulting in an overall cash decrease of $11.8 million Cash Flow Summary (Years Ended December 31) | Cash Flow Activity | 2022 | 2021 | | :-------------------------------------- | :------------- | :------------- | | Net cash used in operating activities | $(10,731,973) | $(7,930,785) | | Net cash used in investing activities | $(407,475) | $(306,868) | | Net cash (used in) provided by financing activities | $(681,645) | $29,698,456 | | Net change in cash and cash equivalents | $(11,821,093) | $21,460,803 | - Operating cash outflow increased in 2022 due to higher net loss and changes in operating assets/liabilities[436](index=436&type=chunk) - Financing activities shifted from a significant inflow in 2021 (IPO) to an outflow in 2022, reflecting payments for deferred offering costs, notes, and leases[440](index=440&type=chunk)[441](index=441&type=chunk) [Off-Balance Sheet Arrangements](index=74&type=section&id=Off-Balance%20Sheet%20Arrangements) Femasys does not have any off-balance sheet arrangements as defined by SEC rules and regulations - Femasys has no off-balance sheet arrangements[442](index=442&type=chunk) [Critical Accounting Policies and Estimates](index=74&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) Femasys's financial statements rely on significant estimates for revenue recognition, accrued expenses (especially R&D), and valuation of financial instruments, with recent accounting standard adoptions having no material impact - Critical accounting policies involve significant estimates and assumptions, including pre-IPO valuation of common stock, stock options, warrants, useful lives of property/equipment, and clinical trial cost accruals[443](index=443&type=chunk)[488](index=488&type=chunk) - Revenue is recognized point-in-time upon shipment when the customer obtains control of goods, with no multiple performance obligations[446](index=446&type=chunk)[520](index=520&type=chunk) - Accrued expenses for R&D activities are estimated based on services provided but not yet invoiced, with adjustments made as actual costs become known[448](index=448&type=chunk)[513](index=513&type=chunk) - The company adopted ASU 2019-12 (Income Taxes) in 2021 with no material impact and expects no significant impact from ASU 2016-13 (Credit Losses) effective for fiscal years beginning after **December 15, 2022**[449](index=449&type=chunk)[540](index=540&type=chunk)[541](index=541&type=chunk) [Item 7A. Quantitative and Qualitative Disclosures About Market Risk](index=75&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Femasys faces low interest rate risk, potential foreign currency risk with international expansion, and managed credit concentration risk after transferring funds from Silicon Valley Bank - Cash and cash equivalents are held in bank deposits and money market funds, carrying a low degree of interest rate risk[450](index=450&type=chunk) - Currently, all sales are in U.S. dollars, but international expansion could increase exposure to foreign currency exchange risk[451](index=451&type=chunk) - Substantially all cash and cash equivalents were held at Silicon Valley Bank (SVB), posing a concentration of credit risk; however, all funds were accessed after SVB's closure in **March 2023**[452](index=452&type=chunk) - Femasys is an emerging growth company and has elected not to use the extended transition period for complying with new or revised financial accounting standards[453](index=453&type=chunk) [Item 8. Financial Statements](index=76&type=section&id=Item%208.%20Financial%20Statements) This section presents Femasys Inc.'s audited financial statements for 2022 and 2021, including balance sheets, statements of comprehensive loss, stockholders' equity, and cash flows, with an auditor's note on going concern doubt - The financial statements for 2022 and 2021 include Balance Sheets, Statements of Comprehensive Loss, Statements of Stockholders' Equity, and Statements of Cash Flows[456](index=456&type=chunk) - KPMG LLP, the independent auditor, issued an opinion that the financial statements are presented fairly, but highlighted substantial doubt about the company's ability to continue as a going concern[459](index=459&type=chunk)[460](index=460&type=chunk) - Notes to the financial statements provide details on organization, accounting policies, fair value, commitments, notes payable, income taxes, stockholders' equity, and equity incentive plans[478](index=478&type=chunk)[488](index=488&type=chunk)[543](index=543&type=chunk)[547](index=547&type=chunk)[550](index=550&type=chunk)[563](index=563&type=chunk)[567](index=567&type=chunk)[578](index=578&type=chunk)[598](index=598&type=chunk)[626](index=626&type=chunk)[627](index=627&type=chunk)[628](index=628&type=chunk) [Report of Independent Registered Public Accounting Firm](index=77&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) KPMG LLP audited Femasys's financial statements for 2022 and 2021, affirming fair presentation but highlighting substantial doubt about the company's ability to continue as a going concern - KPMG LLP audited the financial statements for 2022 and 2021, providing an opinion that they are presented fairly[459](index=459&type=chunk) - The auditor noted substantial doubt about Femasys's ability to continue as a going concern due to recurring losses and negative cash flows[460](index=460&type=chunk) [Balance Sheets](index=78&type=section&id=Balance%20Sheets) As of December 31, 2022, Femasys reported total assets of $16.9 million, a decrease from $28.6 million in 2021, primarily due to reduced cash, and an accumulated deficit of $94.1 million Balance Sheet Summary (as of December 31) | Asset/Liability/Equity | 2022 | 2021 | | :--------------------------------- | :----------- | :----------- | | Cash and Cash Equivalents | $12,961,936 | $24,783,029 | | Total Current Assets | $14,131,491 | $25,631,410 | | Net Property and Equipment | $1,483,051 | $1,599,012 | | Total Assets | $16,895,570 | $28,576,680 | | Total Current Liabilities | $1,527,809 | $1,692,090 | | Total Liabilities | $1,653,051 | $2,244,298 | | Total Stockholders' Equity | $15,242,519 | $26,332,382 | | Accumulated Deficit | $(94,134,505) | $(82,740,335) | - Cash and cash equivalents decreased by **47.7%** from **$24.8 million** in 2021 to **$13.0 million** in 2022[465](index=465&type=chunk) - Accumulated deficit increased by **13.8%** to **$94.1 million** in 2022, reflecting ongoing net losses[467](index=467&type=chunk) [Statements of Comprehensive Loss](index=80&type=section&id=Statements%20of%20Comprehensive%20Loss) Femasys reported a net loss of $11.4 million for the year ended December 31, 2022, a 51.2% increase from the $7.5 million net loss in 2021, driven by a 35.2% surge in operating expenses despite a slight increase in sales Statements of Comprehensive Loss (Years Ended December 31) | Metric | 2022 | 2021 | | :-------------------------- | :----------- | :----------- | | Sales | $1,206,218 | $1,179,689 | | Gross Margin | $764,280 | $809,305 | | Total Operating Expenses | $12,364,544 | $9,146,109 | | Loss from Operations | $(11,600,264) | $(8,336,804) | | Total Other Income (Expense) | $212,394 | $802,959 | | Net Loss | $(11,394,170) | $(7,537,845) | | Net Loss Per Share (Basic & Diluted) | $(0.96) | $(1.12) | - Net loss increased by **51.2%** in 2022, primarily due to a **35.2% increase** in total operating expenses, particularly R&D and sales & marketing[470](index=470&type=chunk) - Gross margin decreased by **5.6%** in 2022, while sales increased by **2.2%**[470](index=470&type=chunk) [Statements of Stockholders' Equity (Deficit)](index=81&type=section&id=Statements%20of%20Stockholders'%20Equity%20(Deficit)) Total stockholders' equity decreased by 42.1% to $15.2 million in 2022, primarily due to the net loss, with the accumulated deficit growing to $94.1 million Stockholders' Equity (Deficit) Summary (as of December 31) | Metric | 2022 | 2021 | | :--------------------------------- | :----------- | :----------- | | Common Stock Shares Outstanding | 11,869,704 | 11,804,165 | | Common Stock Amount | $11,987 | $11,921 | | Warrants | $567,972 | $702,492 | | Additional Paid-in Capital | $108,857,065 | $108,418,304 | | Accumulated Deficit | $(94,134,505) | $(82,740,335) | | Total Stockholders' Equity (Deficit) | $15,242,519 | $26,332,382 | - Total stockholders' equity decreased by **$11,089,863 (42.1%)** from 2021 to 2022, primarily due to the net loss[473](index=473&type=chunk) - Common stock shares outstanding increased due to option exercises and at-the-market offerings, while warrants decreased due to expiration[473](index=473&type=chunk) [Statements of Cash Flows](index=82&type=section&id=Statements%20of%20Cash%20Flows) In 2022, Femasys experienced increased cash outflow from operations and a shift from cash inflow to outflow in financing activities, resulting in an $11.8 million decrease in cash and cash equivalents Cash Flow Summary (Years Ended December 31) | Cash Flow Activity | 2022 | 2021 | | :-------------------------------------- | :------------- | :------------- | | Net cash used in operating activities | $(10,731,973) | $(7,930,785) | | Net cash used in investing activities | $(407,475) | $(306,868) | | Net cash (used in) provided by financing activities | $(681,645) | $29,698,456 | | Net change in cash and cash equivalents | $(11,821,093) | $21,460,803 | - Net cash used in operating activities increased by **35.3%** in 2022, primarily driven by the higher net loss[475](index=475&type=chunk) - Financing activities shifted from a significant cash inflow in 2021 (due to IPO) to a cash outflow in 2022, reflecting debt and lease payments, and deferred offering costs[475](index=475&type=chunk) [Notes to Financial Statements](index=83&type=section&id=Notes%20to%20Financial%20Statements) The notes provide detailed disclosures on Femasys's business, liquidity concerns (going concern doubt), significant accounting policies, and financial details including cash, inventory, R&D expenses, and equity - Femasys is a biomedical company focused on women's healthcare, with lead product candidates FemBloc and FemaSeed[479](index=479&type=chunk)[480](index=480&type=chunk) - Substantial doubt exists about the company's ability to continue as a going concern due to recurring net losses and negative operating cash flows, with current cash expected to fund operations only into **Q1 2024**[483](index=483&type=chunk)[484](index=484&type=chunk) - Key accounting policies include revenue recognition (point-in-time), accrued R&D expenses, and valuation of financial instruments[488](index=488&type=chunk)[520](index=520&type=chunk)[513](index=513&type=chunk) - As of December 31, 2022, the company had **$12,961,936** in cash and cash equivalents, **$436,723** in net inventory, and an accumulated deficit of **$94,134,505**[499](index=499&type=chunk)[425](index=425&type=chunk) - Total R&D expenses were **$5,813,755** in 2022, and the company has federal net operating loss carryforwards of **$82,500,567** and federal R&E tax credits of **$2,838,559**[419](index=419&type=chunk)[573](index=573&type=chunk) - As of December 31, 2022, **931,550 stock options** and **233,400 warrants** were outstanding[605](index=605&type=chunk)[596](index=596&type=chunk) [Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=103&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) Femasys Inc. reported no changes in or disagreements with accountants on accounting and financial disclosure - No changes in or disagreements with accountants on accounting and financial disclosure were reported[629](index=629&type=chunk) [Item 9A. Controls and Procedures](index=103&type=section&id=Item%209A.%20Controls%20and%20Procedures) As of December 31, 2022, Femasys's disclosure controls were ineffective, but internal control over financial reporting was effective after remediating a material weakness through process formalization and personnel hires - Disclosure controls and procedures were **not effective** as of December 31, 2022[630](index=630&type=chunk) - Internal control over financial reporting was assessed as **effective** as of December 31, 2022[631](index=631&type=chunk) - A previously reported material weakness in internal control over financial reporting was remediated by implementing formalized processes and hiring additional accounting personnel[633](index=633&type=chunk) - The company acknowledges inherent limitations in control systems, meaning they provide only reasonable, not absolute, assurance against errors or fraud[635](index=635&type=chunk) [Item 9B. Other Information](index=103&type=section&id=Item%209B.%20Other%20Information) No other information is required to be reported under this item - No other information was reported[636](index=636&type=chunk) [Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=103&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) No disclosures are required regarding foreign jurisdictions that prevent inspections - No disclosures regarding foreign jurisdictions that prevent inspections were reported[637](index=637&type=chunk) [PART III](index=104&type=section&id=PART%20III) This part incorporates by reference information on Femasys's directors, executive officers, corporate governance, executive compensation, security ownership, related transactions, and accounting fees from the 2023 proxy statement [Item 10. Directors, Executive Officers and Corporate Governance](index=104&type=section&id=Item%2010.%20Directors,%20Executive%20Officers%20and%20Corporate%20Governance) Information regarding Femasys's directors, executive officers, and corporate governance, including the Code of Ethics, is incorporated by reference from the definitive proxy statement for the 2023 Annual Meeting of Stockholders - Information on directors, executive officers, and corporate governance is incorporated by reference from the **2023 Annual Meeting of Stockholders proxy statement**[638](index=638&type=chunk) - The board of directors has adopted a Code of Ethics applicable to all directors, officers, and employees, available on the company's website[638](index=638&type=chunk) [Item 11. Executive Compensation](index=104&type=section&id=Item%2011.%20Executive%20Compensation) Information concerning executive compensation is incorporated by reference from the definitive proxy statement for the 2023 Annual Meeting of Stockholders - Executive compensation information is incorporated by reference from the **2023 Annual Meeting of Stockholders proxy statement**[639](index=639&type=chunk) [Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=104&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information regarding security ownership of certain beneficial owners and management, as well as equity compensation plans, is incorporated by reference from the definitive proxy statement for the 2023 Annual Meeting of Stockholders and Item 5 of this 10-K - Information on security ownership of beneficial owners and management is incorporated by reference from the **2023 Annual Meeting of Stockholders proxy statement**[639](index=639&type=chunk) - Equity compensation plan information is incorporated by reference from **Item 5** of this annual report on Form 10-K[640](index=640&type=chunk) [Item 13. Certain Relationships and Related Transactions, and Director Independence](index=104&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions,%20and%20Director%20Independence) Information on certain relationships, related-person transactions, and director independence is incorporated by reference from the definitive proxy statement for the 2023 Annual Meeting of Stockholders - Information on certain relationships, related-person transactions, and director independence is incorporated by reference from the **2023 Annual Meeting of Stockholders proxy statement**[640](index=640&type=chunk) [Item 14. Principal Accounting Fees and Services](index=104&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information regarding principal accounting fees and services is incorporated by reference from the definitive proxy statement for the 2023 Annual Meeting of Stockholders - Information on principal accounting fees and services is incorporated by reference from the **2023 Annual Meeting of Stockholders proxy statement**[641](index=641&type=chunk) [PART IV](index=105&type=section&id=PART%20IV) This part lists all exhibits filed as part of the Form 10-K, including corporate governance documents, equity plans, employment agreements, and officer certifications, and includes the report's signatures [Item 15. Exhibits](index=105&type=section&id=Item%2015.%20Exhibits) This section lists all exhibits filed as part of the Form 10-K, including corporate governance documents, equity plans, employment agreements, indemnification agreements, and officer certifications - The section lists all exhibits filed with the Form 10-K, including corporate governance documents, equity plans, employment agreements, and officer certifications[642](index=642&type=chunk) [Item 16. Form 10-K Summary](index=106&type=section&id=Item%2016.%20Form%2010-K%20Summary) No Form 10-K Summary is provided in this report - No Form 10-K Summary is included in this report[644](index=644&type=chunk) [Signatures](index=107&type=section&id=SIGNATURES) The Form 10-K was signed on March 30, 2023, by Femasys Inc.'s CEO and CFO, along with other directors, and includes a power of attorney for filing amendments - The Form 10-K was signed on **March 30, 2023**, by Kathy Lee-Sepsick (CEO and President) and Dov Elefant (CFO), along with other directors[647](index=647&type=chunk)[651](index=651&type=chunk) - A power of attorney designates Kathy Lee-Sepsick and Daniel Currie as attorneys-in-fact for filing amendments to the report[650](index=650&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________to____________ Commission file number: 001-40492 Femasys Inc. (Exact Name of Registrant as Specified in its Charter) Indicate by check mark wh ...

1 Disrupting Convention in Women's Health Through Continuous Innovation August 2022 Corporate Presentation Forward-Looking Statements This Presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating to our business, operations and financial conditions, including but not limited to current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, results of clinical trials and other futur ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________to____________ Commission file number: 001-40492 Femasys Inc. (Exact Name of Registrant as Specified in its Charter) Indicate by check mark whether ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________to____________ Commission file number: 001-40492 Femasys Inc. (Exact Name of Registrant as Specified in its Charter) Indicate by check mark whethe ...