Full Press Release Details
Femasys Inc. Announces Financial Results for the Second Quarter Ended
June 30, 2022 and Provides Corporate Update
- Continued focus and progress with FemaSeed and FemBloc biomedical product candidates in development
- FemCerv and FemCath commercial availability
expected by year-end
ATLANTA, August 10, 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 second quarter and six months ended June 30, 2022 and provided a corporate update.
"The decision this past quarter announcing the overturn of the landmark Roe v. Wade case
underscores the importance for women to have access to reproductive health options that are safe and reliable, which strongly coincides with Femasys' mission," said Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys. "Now,
more than ever, advanced and modernized reproductive health solutions, like those we are developing for women, are of paramount importance as options for family planning. Safety and choice have always been core drivers in our mission to develop
non-surgical solutions for women around the world. FemBloc is the only permanent birth control alternative in development designed with accessibility and affordability in mind to provide a non-surgical tubal occlusion option to women."
Second Quarter and Recent Developments Related to Clinical Programs
Corporate Highlights
Ms. Lee-Sepsick added, "After extensive preparations last quarter, we are now readying to make two products available to the market in the fourth quarter, in line with
broadening solutions to improve the continuum of healthcare options for women: FemCerv , our endocervical tissue sampler, and FemCath , our selective delivery catheter for fallopian tube evaluation. These two products will be added to
our commercial portfolio along with our FemVue diagnostic product, the first device enabling an in-office ultrasound diagnosis as an alternative to seeing a radiologist, to assess fallopian tubes for infertility. In parallel, we are on
track to complete enrollment in the third quarter for FemBloc our non-surgical permanent birth control solution and in the fourth quarter, conduct an interim analysis for FemaSeed , our novel treatment for infertility."
Second Quarter 2022 Financial Results
Year to Date 2022 (Six-Months) Financial Results
Net loss was $5,517,131, or $0.47 per basic and diluted share attributable to common stockholders, primarily reflecting the factors noted above, for the six months ended June 30, 2022,
compared to $2,913,291, or $1.89 per basic and diluted share attributable to common stockholders, for the six months ended June 30, 2021.
| Assets | June 30, 2022 | December 31, 2021 | ||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 19,116,419 | 24,783,029 | |||||
| Accounts receivable, net | 113,960 | 84,258 | ||||||
| Inventory, net | 244,181 | 208,270 | ||||||
| Other current assets | 854,962 | 555,853 | ||||||
| Total current assets | 20,329,522 | 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 | 2,434,524 | 2,261,793 | ||||||
| Construction in progress | 461,735 | 379,713 | ||||||
| 4,616,187 | 4,321,129 | |||||||
| Less accumulated depreciation | (2,985,367 | ) | (2,722,117 | ) | ||||
| Net property and equipment | 1,630,820 | 1,599,012 | ||||||
| Long-term assets: | ||||||||
| Lease right-of-use assets, net | 486,926 | 665,747 | ||||||
| Intangible assets, net of accumulated amortization | 10,601 | 25,093 | ||||||
| Other long-term assets | 663,083 | 655,418 | ||||||
| Total long-term assets | 1,160,610 | 1,346,258 | ||||||
| Total assets | $ | 23,120,952 | 28,576,680 |
| Liabilities and Stockholders' Equity | June 30, 2022 | December 31, 2021 | ||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 428,325 | 445,522 | |||||
| Accrued expenses | 551,828 | 603,787 | ||||||
| Clinical holdback - current portion | 36,238 | 18,947 | ||||||
| Note payable - current portion | 417,841 | 181,123 | ||||||
| Lease liabilities - current portion | 394,518 | 406,674 | ||||||
| Other - current | 36,037 | 36,037 | ||||||
| Total current liabilities | 1,864,787 | 1,692,090 | ||||||
| Long-term liabilities: | ||||||||
| Clinical holdback - long-term portion | 109,139 | 149,791 | ||||||
| Lease liabilities - long-term portion | 209,098 | 402,417 | ||||||
| Total long-term liabilities | 318,237 | 552,208 | ||||||
| Total liabilities | 2,183,024 | 2,244,298 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Common stock, $.001 par, 200,000,000 authorized, 11,930,833 shares issued and 11,813,610 outstanding as of June 30, 2022; and 11,921,388 shares issued 11,804,165 outstanding as of December 31, 2021 | 11,931 | 11,921 | ||||||
| Treasury stock, 117,223 shares | (60,000 | ) | (60,000 | ) | ||||
| Warrants | 567,972 | 702,492 | ||||||
| Additional paid-in-capital | 108,675,491 | 108,418,304 | ||||||
| Accumulated deficit | (88,257,466 | ) | (82,740,335 | ) | ||||
| Total stockholders' equity | 20,937,928 | 26,332,382 | ||||||
| Total liabilities and stockholders' equity | $ | 23,120,952 | 28,576,680 |
Statements of Comprehensive Loss
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Sales | $ | 303,113 | 326,006 | 624,518 | 655,781 | |||||||||||
| Cost of sales | 102,353 | 107,627 | 225,028 | 200,669 | ||||||||||||
| Gross margin | 200,760 | 218,379 | 399,490 | 455,112 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 1,472,924 | 894,868 | 2,893,987 | 1,889,890 | ||||||||||||
| Sales and marketing | 63,177 | 21,828 | 132,040 | 44,647 | ||||||||||||
| General and administrative | 1,181,938 | 1,051,399 | 2,629,293 | 1,943,386 | ||||||||||||
| Depreciation and amortization | 142,684 | 151,359 | 286,883 | 304,812 | ||||||||||||
| Total operating expenses | 2,860,723 | 2,119,454 | 5,942,203 | 4,182,735 | ||||||||||||
| Loss from operations | (2,659,963 | ) | (1,901,075 | ) | (5,542,713 | ) | (3,727,623 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income, net | 26,745 | 144 | 29,199 | 308 | ||||||||||||
| Other income | - | 821,515 | - | 821,515 | ||||||||||||
| Interest expense | (883 | ) | (3,643 | ) | (3,617 | ) | (7,491 | ) | ||||||||
| Other income, net | 25,862 | 818,016 | 25,582 | 814,332 | ||||||||||||
| Net loss | $ | (2,634,101 | ) | (1,083,059 | ) | (5,517,131 | ) | (2,913,291 | ) | |||||||
| Net loss attributable to common stockholders, basic and diluted | $ | (2,634,101 | ) | (1,083,059 | ) | (5,517,131 | ) | (2,913,291 | ) | |||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.22 | ) | (0.52 | ) | (0.47 | ) | (1.89 | ) | |||||||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 11,812,988 | 2,076,516 | 11,808,601 | 1,538,780 |
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
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 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
Karissa Cross, Ph.D.
LifeSci Communications