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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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(Address of principal executive offices)
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(Zip Code)
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Title of each class
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Trading
Symbol(s)
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Name of each exchange
on which registered
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| Item 2.02 |
Results of Operations and Financial Condition.
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| Item 7.01 |
Regulation FD Disclosure
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| Item 9.01 |
Financial Statements and Exhibits.
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(d)
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Exhibits.
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Exhibit
No.
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Description
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Press Release of Femasys Inc. dated May 11, 2023
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Femasys Inc. Corporate Presentation dated May 2023
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL Document)
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Femasys Inc.
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By:
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/s/ Kathy Lee-Sepsick
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Names: Kathy Lee-Sepsick
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Title: Chief Executive Officer
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| Date: May 11, 2023 | ||
| • |
Recently, in April and May, Femasys received two product approvals, for both FemaSeed and FemCerv, from Health Canada, the Public Health Agency of Canada.
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| o |
FemaSeed is the first-ever infertility
solution designed to deliver sperm directly to where conception occurs. FemaSeed is a localized artificial insemination option designed to be less invasive and more affordable than assisted reproduction.
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| o |
FemCerv is the first endocervical tissue
sampler designed to collect and contain a tissue sample in a relatively pain-free manner to detect the presence of cancerous cells in a woman’s cervix. FemCerv is now commercially available the U.S. and Canada.
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| • |
In April, Femasys raised $3.9 million in a registered direct offering priced at-the-market under Nasdaq rules. The offering closed on April 20, 2023. The proceeds from this
offering will be used for working capital and general corporate purposes and is expected to extend Femasys’ cash runway into the second quarter of 2024.
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| • |
In March, Femasys founder, president and chief executive officer, Kathy Lee-Sepsick, joined other thought leaders in Women’s Health for a panel discussion at SXSW 2023
discussing family planning and infertility options, during a panel, titled, “The Future of Fertility: The Post-Roe Fertility Journey”.
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| • |
Research and development expenses
increased by $116,376 to $1,537,439 for the three months ended March 31, 2023, from $1,421,063 for the three months ended March 31, 2022. The net increase largely consists of a $135,496 increase in compensation and related personnel
costs primarily due to increasing costs associated with hiring and retaining personnel to support our clinical trial.
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| • |
General and administrative expenses
decreased by $132,218 to $1,315,137 for the three months ended March 31, 2023, from $1,447,355 for the three months ended March 31, 2022. The decrease was largely due to a decrease in salaries and related personnel costs, a decrease in
facility and other overhead costs mainly for directors & officers (D&O) insurance, and a decrease in legal and certain professional costs.
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| • |
Sales decreased by $27,421 to $293,984 for
the three months ended March 31, 2023, from $321,405 for the same period last year. U.S. sales, however, increased by $30,624, or 11.6%, for the three months ended March 31, 2023; however, there were no international sales for the three
months ended March 31, 2023, as compared to $58,045 reported for the same period last year, resulting in a decrease in sales. The decrease in sales resulted from the timing of international placed orders. Units sold in the U.S. increased
by 7.1% for the three months ended March 31, 2023, as compared to the same period last year.
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| • |
Sales and marketing expenses increased by
$176,033 to $244,896 for the three months ended March 31, 2023, from $68,863 for the three months ended March 31, 2022. The net increase was primarily due to an increase in compensation and related personnel costs due to an increase in
headcount and marketing costs to promote our commercial efforts.
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| • |
Cost of sales decreased by $17,555 to
$105,120 for the three months ended March 31, 2023, from $122,675 for the three months ended March 31, 2022. The decrease in cost of sales is mainly attributable to increased efficiency achieved through the purchase of new equipment and
tooling which will enable us to reduce labor and material costs in certain manufacturing processes. Gross margin percentage was 64.2% for the three months ended March 31, 2023, as compared to 61.8% for the three months ended March 31,
2022. Gross margins improved due to higher U.S. sales which have lower cost of sales than international sales.
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| • |
Net loss was $2,946,257 or $0.25 per basic
and diluted share attributable to common stockholders, primarily reflecting the factors noted above, for the period ended March 31, 2023, compared to $2,883,030, or $0.24 per basic and diluted share attributable to common stockholders,
for the same period ended March 31, 2022.
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| • |
Cash and cash equivalents as of March 31,
2023 was $10,161,338. Based on our current operating plan, our existing cash and cash equivalents, along with the net proceeds from our recent financing are expected to be sufficient to fund our ongoing operations into the second quarter
of 2024.
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Assets
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March 31, 2023
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December 31,
2022
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||||||
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Current assets:
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||||||||
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Cash and cash equivalents
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$
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10,161,338
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12,961,936
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|||||
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Accounts receivable, net
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123,955
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77,470
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Inventory, net
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500,741
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436,723
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||||||
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Other current assets
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542,067
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655,362
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||||||
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Total current assets
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11,328,101
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14,131,491
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Property and equipment, at cost:
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Leasehold improvements
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1,195,637
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1,195,637
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Office equipment
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99,344
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99,344
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Furniture and fixtures
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419,303
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419,303
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Machinery and equipment
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2,601,389
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2,572,243
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Construction in progress
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406,588
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413,843
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||||||
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4,722,261
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4,700,370
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|||||||
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Less accumulated depreciation
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(3,344,400
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)
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(3,217,319
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)
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Net property and equipment
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1,377,861
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1,483,051
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Long-term assets:
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||||||||
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Lease right-of-use assets, net
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239,351
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319,557
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||||||
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Intangible assets, net of accumulated amortization
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1,881
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3,294
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Other long-term assets
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920,812
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958,177
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||||||
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Total long-term assets
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1,162,044
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1,281,028
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||||||
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Total assets
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$
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13,868,006
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16,895,570
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|||||
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Liabilities and Stockholders’ Equity
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March 31, 2023
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December 31,
2022
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||||||
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Current liabilities:
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||||||||
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Accounts payable
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$
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526,764
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510,758
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Accrued expenses
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535,417
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456,714
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Note payable
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—
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141,298
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||||||
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Clinical holdback - current portion
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45,352
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45,206
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||||||
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Lease liabilities – current portion
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305,071
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373,833
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||||||
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Total current liabilities
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1,412,604
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1,527,809
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Long-term liabilities:
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||||||||
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Clinical holdback - long-term portion
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98,818
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96,658
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||||||
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Lease liabilities – long-term portion
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—
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28,584
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||||||
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Total long-term liabilities
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98,818
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125,242
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Total liabilities
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1,511,422
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1,653,051
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Commitments and contingencies
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||||||||
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Stockholders’ equity:
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||||||||
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Common stock, $.001 par, 200,000,000 authorized, 11,989,796 shares issued and 11,872,573 outstanding as of March 31, 2023; and 11,986,927 shares issued and 11,869,704 outstanding as of December 31, 2022
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11,990
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11,987
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||||||
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Treasury stock, 117,223 shares
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(60,000
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)
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(60,000
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)
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Warrants
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567,972
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567,972
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||||||
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Additional paid-in-capital
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108,917,384
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108,857,065
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Accumulated deficit
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(97,080,762
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)
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(94,134,505
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)
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Total stockholders’ equity
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12,356,584
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15,242,519
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||||||
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Total liabilities and stockholders' equity
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$
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13,868,006
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16,895,570
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|||||
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Three Months Ended March 31,
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||||||||
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2023
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2022
|
|||||||
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Sales
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$
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293,984
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321,405
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|||||
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Cost of sales
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105,120
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122,675
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Gross margin
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188,864
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198,730
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Operating expenses:
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||||||||
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Research and development
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1,537,439
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1,421,063
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||||||
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Sales and marketing
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244,896
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68,863
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||||||
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General and administrative
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1,315,137
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1,447,355
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Depreciation and amortization
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133,066
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144,199
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Total operating expenses
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3,230,538
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3,081,480
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Loss from operations
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(3,041,674
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)
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(2,882,750
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)
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Other income (expense):
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||||||||
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Interest income
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97,089
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2,454
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||||||
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Interest expense
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(1,672
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)
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(2,734
|
)
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||||
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Other income (expense), net
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95,417
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(280
|
)
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|||||
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Net loss
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$
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(2,946,257
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)
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(2,883,030
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)
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|||
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Net loss attributable to common stockholders, basic and diluted
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$
|
(2,946,257
|
)
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(2,883,030
|
)
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|||
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Net loss per share attributable to common stockholders, basic and diluted
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$
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(0.25
|
)
|
(0.24
|
)
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|||
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Weighted-average shares used in computing net loss per share attributable to common stockholders, basic
and diluted
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11,872,255
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11,804,165
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