Exhibit 99.1

Femasys Inc. Announces Financial Results for the Year Ended December 31, 2022 and Provides Corporate Update

 

- 2022 was a landmark year for women in the U.S. due to the overturn of Roe v. Wade which underscored the importance of potential reproductive health options like Femasys’ FemBloc^® for permanent birth control and FemaSeed^® for infertility

 

- The commercial launches of FemCath^TM and FemCerv^® broaden options for women while Femasys continues advancing development of its lead clinical programs FemBloc and FemaSeed^®

 

ATLANTA, March 30, 2023 -- Femasys Inc. (NASDAQ: FEMY), a biomedical company aiming to meet women's needs by developing a suite of products and product candidates that include minimally invasive, in-office technologies for reproductive health, today announced financial results for the year ended December 31, 2022 and provided a corporate update.

 

“This past year was a watershed moment for women in the United States with the overturn of the landmark Roe v. Wade case by the U.S. Supreme Court,” stated Kathy Lee-Sepsick, founder, president and chief executive officer. “The Court’s decision made us more determined than ever to bring our novel permanent birth control solution, FemBloc^® and infertility solution, FemaSeed^®, to women in the U.S. and around the world.  The excitement about our FemBloc and FemaSeed programs was palpable during our recent participation in a panel at the South by Southwest conference where the impact of the Dobbs decision on reproductive health was discussed.  With the recent challenges and unmet needs that are highly apparent in women’s health, we are both energized and inspired in the new year as we become closer to providing safe and affordable alternatives for women worldwide throughout the spectrum of reproduction.”

2022 and Recent Corporate Highlights

Operational and Leadership

Fourth Quarter 2022 Highlights and Recent Developments Related to Clinical Programs

 

 

Fourth Quarter 2022 Highlights and Recent Developments Related to Commercial Programs

FemCath™

FemCerv^®

Ms. Lee-Sepsick added, “In addition to the commercial availability of FemCerv and FemCath last year, we’ve made great progress on advancing our lead FemBloc and FemaSeed clinical programs, continuing the momentum into this year. In October of last year, we announced that we were 25% enrolled for the FemaSeed de novo pivotal trial after updating the study design to focus on couples experiencing male factor infertility, an underserved population. After completing enrollment in our Stage 2 study of FemBloc in the fourth quarter of last year, we remain on track to file an investigational device exemption (IDE) with the U.S. Food and Drug Administration for a pivotal trial to support Premarket approval (PMA) for FemBloc.”

Full Year 2022 Financial Results

 

The increase was primarily due to increases in compensation and related personnel costs primarily in salaries, fringe benefits and share-based compensation expense due to an increase in headcount, clinical-related costs, professional and outside consultant costs, and other costs all to mainly support our clinical trials.

 

 

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.

 

 

About FemCath™

 

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 endocervical tissue sampler designed to improve tissue quality and quantity in a pain-free manner that is expected to be an improvement over the existing standard of care. FemCerv can be used in conjunction with colposcopy and is intended to capture and protect a comprehensive 360-degree tissue sample in a relatively pain-free office visit.

 

FEMASYS INC.
Balance Sheets
(unaudited)
Assets		December 31, 2022				December 31, 2021
Current assets:
Cash and cash equivalents		$	12,961,936				24,783,029
Accounts receivable, net			77,470				84,258
Inventory, net			436,723				208,270
Other current assets			655,362				555,853
Total current assets			14,131,491				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			419,303				424,947
Machinery and equipment			2,572,243				2,261,793
Construction in progress			413,843				379,713
			4,700,370				4,321,129
Less accumulated depreciation			(3,217,319	)			(2,722,117	)
Net property and equipment			1,483,051				1,599,012
Long-term assets:
Lease right-of-use assets, net			319,557				665,747
Intangible assets, net of accumulated amortization			3,294				25,093
Other long-term assets			958,177				655,418
Total long-term assets			1,281,028				1,346,258
Total assets		$	16,895,570				28,576,680

 

(continued)

FEMASYS INC.
Balance Sheets
(unaudited)
Liabilities and Stockholders’ Equity		December 31, 2022				December 31, 2021
Current liabilities:
Accounts payable		$	510,758				445,522
Accrued expenses			456,714				603,787
Clinical holdback - current portion			45,206				18,947
Note payable – current portion			141,298				181,123
Lease liabilities – current portion			373,833				406,674
Other – current			—				36,037
Total current liabilities			1,527,809				1,692,090
Long-term liabilities:
Clinical holdback - long-term portion			96,658				149,791
Lease liabilities – long-term portion			28,584				402,417
Total long-term liabilities			125,242				552,208
Total liabilities			1,653,051				2,244,298
Commitments and contingencies
Stockholders’ equity:
Common stock, $.001 par, 200,000,000 authorized,
11,986,927 shares issued and 11,869,704 outstanding as of
December 31, 2022; and 11,921,388 shares issued
and 11,804,165 outstanding as of December 31, 2021			11,987				11,921
Treasury stock, 117,223 shares			(60,000	)			(60,000	)
Warrants			567,972				702,492
Additional paid-in-capital			108,857,065				108,418,304
Accumulated deficit			(94,134,505	)			(82,740,335	)
Total stockholders’ equity			15,242,519				26,332,382
Total liabilities and stockholders' equity		$	16,895,570				28,576,680

 

FEMASYS INC.
Statements of Comprehensive Loss
(unaudited)
		December 31, 2022				December 31, 2021
Sales		$	1,206,218				1,179,689
Cost of sales			441,938				370,384
Gross margin			764,280				809,305
Operating expenses:
Research and development			5,813,755				4,084,304
Sales and marketing			558,852				208,735
General and administrative			5,430,704				4,262,002
Depreciation and amortization			561,233				591,068
Total operating expenses			12,364,544				9,146,109
Loss from operations			(11,600,264	)			(8,336,804	)
Other income (expense):
Interest income, net			228,164				3,768
Other income			—				821,515
Interest expense			(13,464	)			(19,226	)
Other expense			(2,306	)			(3,098	)
Total other income			212,394				802,959
Loss before income taxes			(11,387,870	)			(7,533,845	)
Income tax expense			6,300				4,000
Net loss		$	(11,394,170	)			(7,537,845	)
Net loss attributable to common stockholders, basic and diluted		$	(11,394,170	)			(7,537,845	)
Net loss per share attributable to common stockholders, basic and diluted		$	(0.96	)			(1.12	)
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted			11,815,019				6,712,028

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.

 

Contacts:

 

Investors

Chuck Padala

LifeSci Advisors, LLC

+1-917-741-7792

Femasys Inc.

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