Full Press Release Details
Femasys Inc. Announces Financial Results for the First Quarter Ended
-Received regulatory approval for both FemaSeed and FemCerv products from Health
ATLANTA, May 11, 2023 -- Femasys Inc. (NASDAQ: FEMY), a biomedical company aiming to meet women's needs worldwide by developing a suite of product
candidates that include minimally invasive, in-office technologies for reproductive health, today announced financial results for the first quarter ended March 31, 2023 and provided a corporate update.
"We continue to expand our commercial portfolio with Health Canada's recent approval of both FemaSeed and FemCerv
to improve the continuum of healthcare options for women," said Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys. "These two product approvals broaden our commercial offerings for women, with FemaSeed complementing
FemVue , our device that enables an in-office ultrasound assessment of the fallopian tubes as part of an infertility diagnosis prior to FemaSeed. Our goal is to further grow this synergistic product portfolio by exploring
commercialization opportunities. These product offerings, along with our lead product candidate, FemBloc permanent birth control, have the potential to address substantial, multi-billion-dollar global market segments by bringing safe,
accessible options to women."
First Quarter 2023 and Recent Corporate Highlights:
First Quarter 2023 Financial Results
PART I. FINANCIAL INFORMATION
ITEM I. Financial Statements
| Assets | March 31, 2023 | December 31, 2022 | ||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 10,161,338 | 12,961,936 | |||||
| Accounts receivable, net | 123,955 | 77,470 | ||||||
| Inventory, net | 500,741 | 436,723 | ||||||
| Other current assets | 542,067 | 655,362 | ||||||
| Total current assets | 11,328,101 | 14,131,491 | ||||||
| Property and equipment, at cost: | ||||||||
| Leasehold improvements | 1,195,637 | 1,195,637 | ||||||
| Office equipment | 99,344 | 99,344 | ||||||
| Furniture and fixtures | 419,303 | 419,303 | ||||||
| Machinery and equipment | 2,601,389 | 2,572,243 | ||||||
| Construction in progress | 406,588 | 413,843 | ||||||
| 4,722,261 | 4,700,370 | |||||||
| Less accumulated depreciation | (3,344,400 | ) | (3,217,319 | ) | ||||
| Net property and equipment | 1,377,861 | 1,483,051 | ||||||
| Long-term assets: | ||||||||
| Lease right-of-use assets, net | 239,351 | 319,557 | ||||||
| Intangible assets, net of accumulated amortization | 1,881 | 3,294 | ||||||
| Other long-term assets | 920,812 | 958,177 | ||||||
| Total long-term assets | 1,162,044 | 1,281,028 | ||||||
| Total assets | $ | 13,868,006 | 16,895,570 |
| Liabilities and Stockholders' Equity | March 31, 2023 | December 31, 2022 | ||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 526,764 | 510,758 | |||||
| Accrued expenses | 535,417 | 456,714 | ||||||
| Note payable | - | 141,298 | ||||||
| Clinical holdback - current portion | 45,352 | 45,206 | ||||||
| Lease liabilities - current portion | 305,071 | 373,833 | ||||||
| Total current liabilities | 1,412,604 | 1,527,809 | ||||||
| Long-term liabilities: | ||||||||
| Clinical holdback - long-term portion | 98,818 | 96,658 | ||||||
| Lease liabilities - long-term portion | - | 28,584 | ||||||
| Total long-term liabilities | 98,818 | 125,242 | ||||||
| Total liabilities | 1,511,422 | 1,653,051 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Common stock, $.001 par, 200,000,000 authorized, 11,989,796 shares issued and 11,872,573 outstanding as of March 31, 2023; and 11,986,927 shares issued and 11,869,704 outstanding as of December 31, 2022 | 11,990 | 11,987 | ||||||
| Treasury stock, 117,223 shares | (60,000 | ) | (60,000 | ) | ||||
| Warrants | 567,972 | 567,972 | ||||||
| Additional paid-in-capital | 108,917,384 | 108,857,065 | ||||||
| Accumulated deficit | (97,080,762 | ) | (94,134,505 | ) | ||||
| Total stockholders' equity | 12,356,584 | 15,242,519 | ||||||
| Total liabilities and stockholders' equity | $ | 13,868,006 | 16,895,570 |
The accompanying notes are an integral part of these unaudited financial statements.
Statements of Comprehensive Loss
| Three Months Ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| Sales | $ | 293,984 | 321,405 | |||||
| Cost of sales | 105,120 | 122,675 | ||||||
| Gross margin | 188,864 | 198,730 | ||||||
| Operating expenses: | ||||||||
| Research and development | 1,537,439 | 1,421,063 | ||||||
| Sales and marketing | 244,896 | 68,863 | ||||||
| General and administrative | 1,315,137 | 1,447,355 | ||||||
| Depreciation and amortization | 133,066 | 144,199 | ||||||
| Total operating expenses | 3,230,538 | 3,081,480 | ||||||
| Loss from operations | (3,041,674 | ) | (2,882,750 | ) | ||||
| Other income (expense): | ||||||||
| Interest income | 97,089 | 2,454 | ||||||
| Interest expense | (1,672 | ) | (2,734 | ) | ||||
| Other income (expense), net | 95,417 | (280 | ) | |||||
| Net loss | $ | (2,946,257 | ) | (2,883,030 | ) | |||
| Net loss attributable to common stockholders, basic and diluted | $ | (2,946,257 | ) | (2,883,030 | ) | |||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.25 | ) | (0.24 | ) | |||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 11,872,255 | 11,804,165 |
FemaSeed is a first-of-its-kind infertility solution in development for directional intrauterine insemination that delivers sperm to the fallopian tube where
conception occurs. It is intended to augment natural fertilization and provide a first-line treatment option for infertility. FemaSeed is designed to be less invasive and more affordable than assisted reproduction, such as in vitro fertilization
(IVF) or intracytoplasmic sperm injection (ICSI).
FemBloc is a first-of-its-kind, nonsurgical, non-implant, in-office solution in development for permanent birth control. It is intended to be a safer option for
women by eliminating the need for anesthesia, incisions, and permanent implants. FemBloc has the potential to offer women a convenient and reliable option for permanent birth control.
In July 2022, Femasys hosted a Key Opinion Leader (KOL) Event with Paul D. Blumenthal, MD, MPH, Professor of Obstetrics and Gynecology at The
Stanford University Medical Center to discuss FemBloc. To listen to a replay of this event, please click here.
FemVue is the first FDA-cleared product that creates natural saline and air contrast and
enables safe, reliable, and real time evaluation of the fallopian tubes with ultrasound. When performed with a uterine cavity assessment, a more comprehensive exam can be achieved from the comfort of the GYN's office.
FemCath is the first FDA-cleared product that allows for selective evaluation of the fallopian tubes by using in conjunction with the FemVue device.
The ultrasound-based diagnostic test is part of an infertility evaluation, which is essential prior to any infertility treatment, including with our other biomedical solution in development, FemaSeed.
FemCerv is the first FDA-cleared product that allows for the capture and protection of a comprehensive 360-degree endocervical tissue sample in a
relatively pain-free office visit. FemCerv features an expandable collection chamber that is exposed during sampling and closed during removal for containment of cervical cells and tissue.
Femasys Inc. is a biomedical company aiming
to meet women's needs worldwide by developing a suite of products and product candidates that include minimally invasive, in-office technologies for reproductive health. Its two lead product candidates are FemBloc permanent birth control and FemaSeed localized directional insemination for infertility. The Company's products currently marketed in
the United States include FemVue for fallopian tube assessment by ultrasound, which can be used in conjunction with FemCath , an intrauterine catheter for selective evaluation of the fallopian tubes, and FemCerv , an endocervical tissue sampler that is the first product of the technology
Forward-Looking Statements
This press release contains forward-looking statements that are subject to substantial risks and uncertainties. Forward-looking statements can
be identified by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "pending," "intend," "believe," "potential," "hope," or "continue" or the negative of these terms or other similar expressions, although not all
forward-looking statements contain these words. Forward-looking statements are based on our current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and
could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ
include, among others: our ability to develop and advance our current product candidates and programs into, and successfully initiate, enroll and complete, clinical trials; the ability of our clinical trials to demonstrate safety and
effectiveness of our product candidates and other positive results; estimates regarding the total addressable market for our product candidates; our business model and strategic plans for our products, technologies and business, including our
implementation thereof; and those other risks and uncertainties described in the section titled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2022 and other reports as filed with the SEC. Forward-looking
statements contained in this press release are made as of this date, and Femasys undertakes no duty to update such information except as required under applicable law.
LifeSci Advisors, LLC