Femasys Announces Financial Results for Year Ended December 31, 2023 and Provides Corporate Update
- FDA clearance of FemaSeed® for infertility treatment
- Positive topline data from pivotal trial for FemaSeed®
- Enrollment completion for FemaSeed® pivotal trial
- Activated enrollment for FemBloc® pivotal trial
- Appointment of Chief Commercial Officer and Chief Medical Officer
- Expected cash to fund operations into 2H 2025
- Increase in Research and Development expenses
- Decrease in sales
- Net loss for the year ended December 31, 2023
- Accumulated deficit of $108,381,629
Insights
The recent FDA clearance of FemaSeed® represents a pivotal moment for Femasys Inc., potentially altering its financial trajectory. The capital raise to support commercial initiatives suggests investor confidence in the product's market viability. However, it is imperative to scrutinize the company's financial health. The reported increase in R&D expenses aligns with the company's push towards innovation, yet the decline in sales year-over-year raises concerns. The net loss widening from $11.4 million in 2022 to $14.2 million in 2023, despite a lower loss per share, indicates growing operational costs not yet offset by revenues. The cash position is robust, with funding projected to last into the second half of 2025, but the accumulated deficit of over $108 million warrants attention. The market's response to FemaSeed's commercial launch will be critical in assessing the long-term sustainability of Femasys' financial model.
The 24% pregnancy rate in the severe male factor cohort using FemaSeed® is a compelling statistic, underscoring the product's potential efficacy. This performance metric could position FemaSeed as a competitive player in the infertility treatment market, which is characterized by high demand and limited non-surgical options. The successful completion of the pivotal trial and the planned commercial launch could catalyze a shift in treatment paradigms. However, the long-term success of FemaSeed hinges on broader market acceptance and the ability to maintain a favorable safety and efficacy profile compared to existing treatments. Additionally, the progression of FemBloc®, a non-surgical birth control solution, into further clinical trials could diversify the company's portfolio, addressing the substantial need for innovative contraceptive options.
The appointment of a new Chief Commercial Officer and Chief Medical Officer signals strategic moves to strengthen Femasys Inc.'s market positioning. The focus on women's healthcare, an underserved sector, presents significant growth opportunities. Market dynamics suggest that innovative and cost-effective solutions like FemaSeed® could disrupt the current infertility treatment landscape. The company's ability to navigate the commercialization process and effectively market to healthcare providers and patients will be critical. Investors should monitor adoption rates post-launch and payer coverage decisions, which will be instrumental in determining the product's market penetration and, consequently, the company's revenue growth potential.
Following FDA Clearance of FemaSeed®, Company Secures Capital to Support Commercial Initiatives; Cash Expected to Fund Operations Into 2H 2025
ATLANTA, March 28, 2024 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible and innovative therapeutic and diagnostic products, announces financial results for the year ended December 31, 2023 and provides a corporate update.
Corporate Highlights from 4Q 2023 to date
- Company announced positive topline data from pivotal trial for FDA-cleared FemaSeed® for the treatment of infertility
- Following FDA clearance of FemaSeed, the Company’s revolutionary approach to artificial insemination, Femasys announced completion of enrollment in pivotal trial in support of commercial launch
- Activated enrollment for remaining clinical sites of initial phase of pivotal trial for FemBloc®, the Company’s proprietary solution for permanent non-surgical birth control
- Appointed Richard Spector as Chief Commercial Officer and James Liu, M.D. as Chief Medical Officer
“The end of 2023 marked a significant milestone for the Company as we achieved the FDA clearance of FemaSeed, enabling it to become a first-line accessible and cost-effective therapeutic option for couples and women experiencing infertility. We also announced positive topline data for the product’s pivotal trial earlier this month, revealing that
Financial Results for Year Ended December 31, 2023
- Research and Development expenses increased by
$1,394,946 t o$7,208,701 in 2023 from$5,813,755 in 2022 - Sales decreased by
$134,248 t o$1,071,970 in 2023 from$1,206,218 in 2022 - Net loss was
$14,247,124 or$0.93 per basic and diluted share attributable to common stockholders, for the year ended December 31, 2023, compared to net loss of$11,394,170 , or$0.96 per basic and diluted share attributable to common stockholders, for the year ended December 31, 2022 - Cash and cash equivalents as of December 31, 2023 was
$21,716,077 and the Company had an accumulated deficit of$108,381,629. T he Company expects, based on its current operating plan, that its existing cash and cash equivalents will be sufficient to fund its ongoing operations into the second half of 2025
For more information, please refer to the Company’s Form 10-K filed March 28, 2024, which can be accessed on the SEC website.
| FEMASYS INC. | |||||||||||||
| Balance Sheets | |||||||||||||
| (unaudited) | |||||||||||||
| Assets | December 31, 2023 | December 31, 2022 | |||||||||||
| Current assets: | |||||||||||||
| Cash and cash equivalents | $ | 21,716,077 | 12,961,936 | ||||||||||
| Accounts receivable, net | 98,906 | 77,470 | |||||||||||
| Inventory, net | 667,118 | 436,723 | |||||||||||
| Prepaid and other current assets | 695,879 | 655,362 | |||||||||||
| Total current assets | 23,177,980 | 14,131,491 | |||||||||||
| Property and equipment, at cost: | |||||||||||||
| Leasehold improvements | 1,212,417 | 1,195,637 | |||||||||||
| Office equipment | 47,308 | 99,344 | |||||||||||
| Furniture and fixtures | 414,303 | 419,303 | |||||||||||
| Machinery and equipment | 2,559,356 | 2,572,243 | |||||||||||
| Construction in progress | 423,077 | 413,843 | |||||||||||
| 4,656,461 | 4,700,370 | ||||||||||||
| Less accumulated depreciation | (3,545,422 | ) | (3,217,319 | ) | |||||||||
| Net property and equipment | 1,111,039 | 1,483,051 | |||||||||||
| Long-term assets: | |||||||||||||
| Lease right-of-use assets, net | 2,380,225 | 319,557 | |||||||||||
| Intangible assets, net of accumulated amortization | — | 3,294 | |||||||||||
| Other long-term assets | 1,086,581 | 958,177 | |||||||||||
| Total long-term assets | 3,466,806 | 1,281,028 | |||||||||||
| Total assets | $ | 27,755,825 | 16,895,570 | ||||||||||
| (continued) | |||||||||||||
| FEMASYS INC. | |||||||||||||
| Balance Sheets | |||||||||||||
| (unaudited) | |||||||||||||
| Liabilities and Stockholders’ Equity | December 31, 2023 | December 31, 2022 | |||||||||||
| Current liabilities: | |||||||||||||
| Accounts payable | $ | 1,137,823 | 510,758 | ||||||||||
| Accrued expenses | 1,444,296 | 456,714 | |||||||||||
| Note payable | — | 141,298 | |||||||||||
| Clinical holdback – current portion | 65,300 | 45,206 | |||||||||||
| Lease liabilities – current portion | 406,636 | 373,833 | |||||||||||
| Total current liabilities | 3,054,055 | 1,527,809 | |||||||||||
| Long-term liabilities: | |||||||||||||
| Clinical holdback – long-term portion | 54,935 | 96,658 | |||||||||||
| Convertible notes payable, net (including related parties) | 4,258,179 | — | |||||||||||
| Lease liabilities – long-term portion | 2,036,067 | 28,584 | |||||||||||
| Total long-term liabilities | 6,349,181 | 125,242 | |||||||||||
| Total liabilities | 9,403,236 | 1,653,051 | |||||||||||
| Commitments and contingencies | |||||||||||||
| Stockholders’ equity: | |||||||||||||
| Common stock, $.001 par, 200,000,000 authorized, | |||||||||||||
| 21,774,604 shares issued and 21,657,381 outstanding as of | |||||||||||||
| December 31, 2023; and 11,986,927 shares issued | |||||||||||||
| and 11,869,704 outstanding as of December 31, 2022 | 21,775 | 11,987 | |||||||||||
| Treasury stock, 117,223 common shares | (60,000 | ) | (60,000 | ) | |||||||||
| Warrants | 2,787,137 | 567,972 | |||||||||||
| Additional paid-in-capital | 123,985,306 | 108,857,065 | |||||||||||
| Accumulated deficit | (108,381,629 | ) | (94,134,505 | ) | |||||||||
| Total stockholders’ equity | 18,352,589 | 15,242,519 | |||||||||||
| Total liabilities and stockholders' equity | $ | 27,755,825 | 16,895,570 | ||||||||||
| FEMASYS INC. | |||||||||||||
| Statements of Comprehensive Loss | |||||||||||||
| (unaudited) | |||||||||||||
| December 31, 2023 | December 31, 2022 | ||||||||||||
| Sales | $ | 1,071,970 | 1,206,218 | ||||||||||
| Cost of sales (excluding depreciation expense) | 380,069 | 441,938 | |||||||||||
| Operating expenses: | |||||||||||||
| Research and development | 7,208,701 | 5,813,755 | |||||||||||
| Sales and marketing | 650,126 | 558,852 | |||||||||||
| General and administrative | 6,858,008 | 5,430,704 | |||||||||||
| Depreciation and amortization | 483,481 | 561,233 | |||||||||||
| Total operating expenses | 15,200,316 | 12,364,544 | |||||||||||
| Loss from operations | (14,508,415 | ) | (11,600,264 | ) | |||||||||
| Other income (expense): | |||||||||||||
| Interest income | 431,019 | 228,164 | |||||||||||
| Interest expense | (165,390 | ) | (13,464 | ) | |||||||||
| Other expense | — | (2,306 | ) | ||||||||||
| Total other income | 265,629 | 212,394 | |||||||||||
| Loss before income taxes | (14,242,786 | ) | (11,387,870 | ) | |||||||||
| Income tax expense | 4,338 | 6,300 | |||||||||||
| Net loss | $ | (14,247,124 | ) | (11,394,170 | ) | ||||||||
| Net loss attributable to common stockholders, basic and diluted | $ | (14,247,124 | ) | (11,394,170 | ) | ||||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.93 | ) | (0.96 | ) | ||||||||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 15,384,376 | 11,815,019 | |||||||||||
About Femasys
Femasys is a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic solutions, including a lead revolutionary product candidate and FDA-cleared products. Femasys’ FemBloc® permanent birth control in late-stage clinical development is the first and only non-surgical, in-office, permanent birth control method intended to be a safer option for women at substantially less cost than the long-standing surgical alternative. Femasys’ FemaSeed® Intratubal Insemination, an innovative infertility treatment designed to deliver sperm directly where conception occurs, is FDA-cleared and has received regulatory approval in Canada. The Company has developed diagnostic products that are complementary for which it has achieved regulatory approvals to market in the U.S., Canada, and other ex-U.S. territories, and which are commercial-ready due to its 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. Learn more at www.femasys.com, or follow us on X, 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 products and product candidates; our ability to commercialize our products and product candidates, or the effect of delays in commercializing our products, including FemaSeed; 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, 2023, when filed, 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:
Gene Mannheimer
IR@femasys.com
Media Contact:
Kati Waldenburg
Media@femasys.com
FAQ
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