Full Press Release Details
Femasys Inc. Announces Financial Results for the Second Quarter Ended
June 30, 2023 and Provides Corporate Update
- Patient enrollment has commenced in landmark pivotal trial for lead product candidate, FemBloc
- Three product approvals achieved in Canada for FemaSeed , FemCerv and FemCath
products during the second quarter
- Raised $3.9 million in a registered direct offering
ATLANTA, August 10, 2023 -- Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting women's unmet needs worldwide by developing a broad portfolio of
innovative product candidates and products that include minimally invasive, in-office technologies for reproductive health, today announced financial results for the second quarter ended June 30, 2023 and provided a corporate update.
"The past quarter, we made significant, notable progress on all fronts to advance our
synergistic programs in women's health - from ushering forward the clinical development of our lead product candidates to broadening access to our complimentary diagnostic products by gaining additional commercial approvals," said Kathy
Lee-Sepsick, founder, president and chief executive officer of Femasys. "We continue to successfully advance our lead product FemBloc for permanent birth control through the regulatory process with achievement of Investigational Device Exemption
(IDE) approval from the United States Food and Drug Administration (FDA) for the landmark pivotal trial. Thereafter, we were very pleased to announce the rapid initiation of enrollment in this trial, a very important milestone achieved for Femasys, brining us closer to making this much needed non-surgical alternative available to women."
Ms. Lee-Sepsick, continued, "Of note this quarter, we received three new product
approvals in Canada, including for FemaSeed, the first-ever, first-line approach
designed to deliver sperm directly where conception occurs, broadening our commercial offerings, as we strive to bring safe, accessible novel options to
women. We are exploring potential partnerships to maximize the value of our approved and available assets as we remain focused on prioritizing our use of capital on advancing our critical product candidates to ensure continued progress."
Second Quarter 2023 and Recent Corporate Highlights:
Second Quarter 2023 Financial Results
Year to Date 2023 (Six-Month) Financial Results
| Assets | June 30, 2023 | December 31, 2022 | ||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 10,705,017 | 12,961,936 | |||||
| Accounts receivable, net | 155,746 | 77,470 | ||||||
| Inventory, net | 581,474 | 436,723 | ||||||
| Other current assets | 587,828 | 655,362 | ||||||
| Total current assets | 12,030,065 | 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 | 2,628,509 | 2,572,243 | ||||||
| Construction in progress | 384,888 | 413,843 | ||||||
| 4,727,681 | 4,700,370 | |||||||
| Less accumulated depreciation | (3,472,349 | ) | (3,217,319 | ) | ||||
| Net property and equipment | 1,255,332 | 1,483,051 | ||||||
| Long-term assets: | ||||||||
| Lease right-of-use assets, net | 162,006 | 319,557 | ||||||
| Intangible assets, net of accumulated amortization | 970 | 3,294 | ||||||
| Other long-term assets | 865,588 | 958,177 | ||||||
| Total long-term assets | 1,028,564 | 1,281,028 | ||||||
| Total assets | $ | 14,313,961 | 16,895,570 |
| Liabilities and Stockholders' Equity | June 30, 2023 | December 31, 2022 | ||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 546,877 | 510,758 | |||||
| Accrued expenses | 536,830 | 456,714 | ||||||
| Note payable | - | 141,298 | ||||||
| Clinical holdback - current portion | 88,738 | 45,206 | ||||||
| Lease liabilities - current portion | 209,098 | 373,833 | ||||||
| Total current liabilities | 1,381,543 | 1,527,809 | ||||||
| Long-term liabilities: | ||||||||
| Clinical holdback - long-term portion | 56,245 | 96,658 | ||||||
| Lease liabilities - long-term portion | - | 28,584 | ||||||
| Total long-term liabilities | 56,245 | 125,242 | ||||||
| Total liabilities | 1,437,788 | 1,653,051 | ||||||
| Commitments and contingencies Stockholders' equity: | ||||||||
| Common stock, $.001 par, 200,000,000 authorized, 15,190,376 shares issued and 15,073,153 outstanding as of June 30, 2023; and 11,986,927 shares issued and 11,869,704 outstanding as of December 31, 2022 | 15,190 | 11,987 | ||||||
| Treasury stock, 117,223 shares | (60,000 | ) | (60,000 | ) | ||||
| Warrants | 1,918,103 | 567,972 | ||||||
| Additional paid-in-capital | 110,977,150 | 108,857,065 | ||||||
| Accumulated deficit | (99,974,270 | ) | (94,134,505 | ) | ||||
| Total stockholders' equity | 12,876,173 | 15,242,519 | ||||||
| Total liabilities and stockholders' equity | $ | 14,313,961 | 16,895,570 |
Statements of Comprehensive Loss
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| $ | 320,514 | 303,113 | 614,498 | 624,518 | ||||||||||||
| Sales | 110,469 | 102,353 | 215,589 | 225,028 | ||||||||||||
| Cost of sales | 210,045 | 200,760 | 398,909 | 399,490 | ||||||||||||
| Gross margin | ||||||||||||||||
| Operating expenses: | 1,527,172 | 1,472,924 | 3,064,611 | 2,893,987 | ||||||||||||
| Research and development | 128,899 | 63,177 | 373,795 | 132,040 | ||||||||||||
| Sales and marketing | 1,356,637 | 1,181,938 | 2,671,774 | 2,629,293 | ||||||||||||
| General and administrative | 133,299 | 142,684 | 266,365 | 286,883 | ||||||||||||
| Depreciation and amortization | 3,146,007 | 2,860,723 | 6,376,545 | 5,942,203 | ||||||||||||
| Total operating expenses | (2,935,962 | ) | (2,659,963 | ) | (5,977,636 | ) | (5,542,713 | ) | ||||||||
| Loss from operations | ||||||||||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 42,652 | 26,745 | 139,741 | 29,199 | ||||||||||||
| Interest expense | (198 | ) | (883 | ) | (1,870 | ) | (3,617 | ) | ||||||||
| Other income (expense), net | 42,454 | 25,862 | 137,871 | 25,582 | ||||||||||||
| Net loss | $ | (2,893,508 | ) | (2,634,101 | ) | (5,839,765 | ) | (5,517,131 | ) | |||||||
| Net loss attributable to common stockholders, basic and diluted | $ | (2,893,508 | ) | (2,634,101 | ) | (5,839,765 | ) | (5,517,131 | ) | |||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.22 | ) | (0.22 | ) | (0.47 | ) | (0.47 | ) | |||||||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 13,107,590 | 11,812,988 | 12,493,334 | 11,808,601 |
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, non-surgical, non-implant, in-office solution in late-stage clinical development for permanent birth control. It is intended to be a safer
option for women and its cost is estimated to be substantially less than the long-standing surgical alternative by eliminating the need for anesthesia, incisions, and permanent implants. FemBloc has the potential to offer a convenient,
accessible, and reliable option to women seeking permanent birth control. For over 100 years, there has been stagnant innovation in the area of permanent birth control; this could lead to a $20 billion market expansion opportunity for FemBloc in
the U.S. alone. For more information, visit www.FemBloc.com.
About FemVue 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 for diagnosis of cervical cancer.
Femasys Inc. is a biomedical company focused on meeting women's unmet needs worldwide by developing a broad portfolio of innovative product candidates and products that
include minimally invasive, in-office technologies for reproductive health. Its two lead product candidates in late-stage clinical development are FemBloc permanent birth control and FemaSeed localized directional
insemination for infertility. The Company has developed diagnostic products that complement these two lead product candidates for which it has achieved regulatory approvals to market in the U.S., Canada and other countries outside the U.S and are
commercial ready with in-house manufacturing capabilities. The Company's diagnostic products include FemVue for fallopian tube assessment by ultrasound, which can be used in conjunction with FemCath , an intrauterine catheter
for selective fallopian tube evaluation, and FemCerv , an endocervical tissue sampler for cervical cancer diagnosis. FemaSeed, FemCerv, and FemCath have also received product approval in Canada. Learn more at www.femasys.com, or follow
us on Twitter, Facebook and LinkedIn.
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