Full Press Release Details
Femasys Inc. Announces Financial Results for the First Quarter Ended
Furthers advancement of much-needed minimally invasive technologies for underserved areas of women's health with pending
commercialization of products, FemCerv and FemCath expected by year-end
Continued progress with FemaSeed and FemBloc biomedical product candidates in development
ATLANTA, May 11, 2022 -- 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, 2022.
"We are adding two approved products to our commercial portfolio as we broaden solutions to improve the continuum of healthcare options for women," said Kathy Lee-Sepsick,
founder, president and chief executive officer of Femasys. "FemCath, our selective delivery catheter, and FemCerv, our endocervical tissue sampler, are pending commercialization later this year, while supporting commercial efforts for our
complementary FemVue diagnostic product, the first device enabling an in-office ultrasound diagnosis, an alternative approach to assess the fallopian tubes for infertility. Our goal is to further grow this synergistic product portfolio
by exploring partnering opportunities and with our product candidates, FemBloc for permanent birth control and FemaSeed for infertility treatment once approved, designed to address substantial, multi-billion-dollar global market segments."
Ms. Lee-Sepsick added, "Women deserve safe options and the right to control their reproductive health and journey. In terms of the recent discussions regarding
Roe v Wade, a ruling which occurred over 48 years ago, safety for women should be upheld as paramount. Safety and choice are core drivers in our mission to develop non-surgical reproductive health solutions for women around the world."
First Quarter 2022 Highlights: Augmented Leadership
First Quarter 2022 and Recent Developments Related to Clinical Programs
Ms. Lee-Sepsick continued, "We are on target to meet our milestones later this year in terms of obtaining an interim read-out from our up to
792-patient LOCAL de novo trial for FemaSeed. Recently, we added a number of new sites to our LOCAL trial, and we are encouraged that the impact of the pandemic may be waning, which has broadly affected enrollment for many clinical trials in the
industry. In addition, we are approaching enrollment completion for our FemBloc study, and are on track for submitting our Investigational Device Exemption (IDE) filing early next year for a pivotal trial, which will be used in support of a
Pre-Market Authorization (PMA) application for this product candidate."
First Quarter 2022 Financial Results
Cost of sales and gross margin percentage
| Assets | March 31, 2022 | December 31, 2021 | ||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 21,767,634 | 24,783,029 | |||||
| Accounts receivable, net | 170,302 | 84,258 | ||||||
| Inventory, net | 223,008 | 208,270 | ||||||
| Other current assets | 567,300 | 555,853 | ||||||
| Total current assets | 22,728,244 | 25,631,410 | ||||||
| Property and equipment, at cost: | ||||||||
| Leasehold improvements | 1,195,637 | 1,155,332 | ||||||
| Office equipment | 99,344 | 99,344 | ||||||
| Furniture and fixtures | 424,947 | 424,947 | ||||||
| Machinery and equipment | 2,287,126 | 2,261,793 | ||||||
| Construction in progress | 434,443 | 379,713 | ||||||
| 4,441,497 | 4,321,129 | |||||||
| Less accumulated depreciation | (2,854,315 | ) | (2,722,117 | ) | ||||
| Net property and equipment | 1,587,182 | 1,599,012 | ||||||
| Long-term assets: | ||||||||
| Lease right-of-use assets, net | 574,943 | 665,747 | ||||||
| Intangible assets, net of accumulated amortization | 17,663 | 25,093 | ||||||
| Other long-term assets | 625,418 | 655,418 | ||||||
| Total long-term assets | 1,218,024 | 1,346,258 | ||||||
| Total assets | $ | 25,533,450 | 28,576,680 |
| Liabilities and Stockholders' Equity | March 31, 2022 | December 31, 2021 | ||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 548,377 | 445,522 | |||||
| Accrued expenses | 565,228 | 603,787 | ||||||
| Clinical holdback - current portion | 36,238 | 18,947 | ||||||
| Note payable - current portion | 45,666 | 181,123 | ||||||
| Lease liabilities - current portion | 400,620 | 406,674 | ||||||
| Other - current | 36,037 | 36,037 | ||||||
| Total current liabilities | 1,632,166 | 1,692,090 | ||||||
| Long-term liabilities: | ||||||||
| Clinical holdback - long-term portion | 102,502 | 149,791 | ||||||
| Lease liabilities - long-term portion | 305,071 | 402,417 | ||||||
| Total long-term liabilities | 407,573 | 552,208 | ||||||
| Total liabilities | 2,039,739 | 2,244,298 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Common stock, $.001 par, 200,000,000 authorized, 11,921,388 shares issued and 11,804,165 outstanding as of March 31, 2022 and December 31, 2021 | 11,921 | 11,921 | ||||||
| Treasury stock, 117,223 shares | (60,000 | ) | (60,000 | ) | ||||
| Warrants | 702,492 | 702,492 | ||||||
| Additional paid-in-capital | 108,462,663 | 108,418,304 | ||||||
| Accumulated deficit | (85,623,365 | ) | (82,740,335 | ) | ||||
| Total stockholders' equity | 23,493,711 | 26,332,382 | ||||||
| Total liabilities and stockholders' equity | $ | 25,533,450 | 28,576,680 |
Statements of Comprehensive Loss
| Three Months Ended March 31, | ||||||||
| 2022 | 2021 | |||||||
| Sales | $ | 321,405 | 329,775 | |||||
| Cost of sales | 122,675 | 93,042 | ||||||
| Gross margin | 198,730 | 236,733 | ||||||
| Operating expenses: | ||||||||
| Research and development | 1,421,063 | 995,022 | ||||||
| Sales and marketing | 68,863 | 22,819 | ||||||
| General and administrative | 1,447,355 | 891,987 | ||||||
| Depreciation and amortization | 144,199 | 153,453 | ||||||
| Total operating expenses | 3,081,480 | 2,063,281 | ||||||
| Loss from operations | (2,882,750 | ) | (1,826,548 | ) | ||||
| Other income (expense): | ||||||||
| Interest income, net | 2,454 | 164 | ||||||
| Interest expense | (2,734 | ) | (3,848 | ) | ||||
| Other expense, net | (280 | ) | (3,684 | ) | ||||
| Net loss | $ | (2,883,030 | ) | (1,830,232 | ) | |||
| Net loss attributable to common stockholders, basic and diluted | $ | (2,883,030 | ) | (1,830,232 | ) | |||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.24 | ) | (1.84 | ) | |||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 11,804,165 | 995,208 |
Femasys Inc. is 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. Its two lead product candidates are FemBloc permanent birth control and FemaSeed localized directional insemination for infertility. The Company's product for fallopian tube assessment
by ultrasound, FemVue , is currently marketed in the United States. Femasys is also advancing 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 platform for tissue sampling intended to be marketed alongside its other women-specific medical products in the physician's office setting.
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" 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, 2021 and our Form 10-Q for the quarter ended March 31, 2022, when filed with the Securities and Exchange Commission (the
"SEC"), 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
LifeSci Communications