Femasys Inc. (NASDAQ: FEMY), a biomedical company developing a suite of product candidates to transform women’s healthcare with minimally invasive, non-surgical, in-office technologies, today announced financial results for the second quarter and six months ended June 30, 2021.
Completed initial public offering (“IPO”) raising net proceeds of $31.6 million
Appointed Anne Morrissey to the Board of Directors, an industry expert with decades of medical device experience
Initiated 792-patient, pivotal LOCAL trial after receipt of investigational device exemption (IDE) submission approval for FemaSeed™
ATLANTA, Aug. 11, 2021 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company developing a suite of product candidates to transform women’s healthcare with minimally invasive, non-surgical, in-office technologies, today announced financial results for the second quarter and six months ended June 30, 2021.
“This is an exciting time of growth for Femasys after becoming a publicly traded company on June 18th,” stated Kathy Lee-Sepsick, president, chief executive officer and founder of Femasys. “We are galvanizing on all fronts to advance FemaSeed™, our localized directional insemination product candidate that is part of our fertility portfolio, through clinical development and are thrilled to have treated the first patient in our prospective, multi-center pivotal LOCAL trial in July.”
Ms. Lee-Sepsick, further commented, “We are continuing our clinical work with FemBloc®, our permanent birth control product candidate, in preparation for an IDE submission for a pivotal trial planned for next year. Both reproductive products may provide women access to superior technologies and increase their options related to reproductive care. We remain enthusiastic and poised to address the vast underserved markets within women’s health worldwide with our next-generation medical solutions.”
Recent Corporate Developments
- On June 17, 2021, Femasys announced the pricing of its initial public offering of 2,650,000 shares of its common stock at a public price of $13.00 per share. The net proceeds to Femasys from the offering, after deducting the underwriting discounts and commissions and legal expenses, totaled $31,613,500. Shares began trading on the Nasdaq Capital Market on June 18, 2021, under the ticker symbol “FEMY”. The offering closed on June 22, 2021.
- On June 24, 2021, Femasys announced the appointment of Anne Morrissey to the company’s board of directors. Ms. Morrissey brings decades of experience to Femasys. Most recently, Anne served as President and Chief Executive Officer of Alydia Health from 2016 to 2020, and thereafter as an advisor until it was acquired by Merck in March 2021. She holds several patents on medical devices and advises medical device companies, including Raydiant Oximetry.
Recent Developments Related to Clinical Programs
- On April 8, 2021, Femasys received IDE approval to begin a multi-center, pivotal clinical trial (the “LOCAL trial”) of FEMASEED, a first-in-class, localized directional insemination product candidate for infertility.
- On July 20, 2021, Femasys announced the initiation and first patient treated in the LOCAL trial. The trial is being conducted across approximately 20 centers in the United States and is expected to enroll up to 792 patients diagnosed as infertile. The primary endpoints of the study are to determine the effectiveness (clinical pregnancy rate) and safety over a period of 7 weeks. Enrollment in this trial is ongoing.
Second Quarter (Three-Months) 2021 Financial Results:
- Research and Development expenses increased 0.7%, to $894,868 for the second quarter of 2021 compared the second quarter of 2020. The increase was primarily due to compensation and personnel related costs, an increase in clinical-related costs related to FemBloc studies, but was offset by decreases in material and development costs and other costs.
- General and Administrative expenses increased by $507,774, or 93.4% to $1,051,399 for the second quarter of 2021 compared to the second quarter of 2020. The increase was primarily due to an increase of $412,076 in professional costs associated with the company’s financing transactions and other administrative costs, such as insurance.
- Sales of the Company’s FemVue product, increased by $142,772, or 77.9%, to $326,006 from $183,234 for the second quarter of 2021. The net sales increase accounted for a decrease in sales for the three-months ending June 30, 2020 due to impacts of the COVID-19 pandemic. U.S. sales comprised a 46.3% increase for the second quarter of 2021 compared to the same period last year.
- Primarily reflecting the factors noted above, net loss was $1,083,059, or $0.52 per diluted share, for the second quarter of 2021, compared to $1,485,451, or $1.55 per diluted for the second quarter of 2020.
- The cash and cash equivalents balance as of June 30, 2021 was $29,858,868. The Company expects, based on its current operating plan, that its existing cash and cash equivalents, together with the net proceeds from the IPO, will be sufficient to fund its operations at least through 2022.
Year to Date 2021 (Six-Months) Financial Results:
- Research and Development expenses decreased by $349,512, or 15.6% to $1,889,890 for the six months ended June 30, 2021 compared to the six months ended June 30, 2020. The decrease was primarily due to the decrease of $170,249 in compensation and related personnel costs due to the reduction in staff in March 2020, along with a decrease in clinical-related costs related to FemBloc studies and decreases in material and development costs.
- General and Administrative expenses increased by $749,569, or 62.8%, to $1,943,386 for the six months ended June 30, 2021 compared to the six months ended June 30, 2020. The increase was largely due to an increase of $740,734 in professional costs associated with the Company’s financing transactions.
- Sales of the Company’s FemVue product increased by $212,035, or 47.8%, to $655,781 from $443,746 for the six-months ended June 30, 2020. The increase was attributed to a $156,240 increase in U.S. sales and a $55,795 increase in international sales, primarily due to the impacts of the COVID-19 pandemic.
- Primarily reflecting the factors noted above, net loss decreased to $2,913,291, or $1.89 per diluted share, for the six months ended June 30 2021, as compared to a net loss of $3,687,178, or $3.86 per diluted share, for the six months ended June 30, 2020.
About Femasys
Femasys is a biomedical company developing a suite of product candidates to transform women’s healthcare with minimally invasive, non-surgical, in-office technologies. Its two lead reproductive health product candidates include 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 FemCerv®, a technology platform for tissue sampling intended to be marketed alongside our 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,” “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 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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on August 11, 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.
Contacts:
Investors
Chuck Padala
LifeSci Advisors, LLC
+1-917-741-7792
chuck@lifesciadvisors.com
Media
Sky Striar
LifeSci Communications
sstriar@lifescicomms.com
Femasys Inc.
Investor Contact:
IR@femasys.com
Media Contact:
Media@femasys.com
| FEMASYS INC. | ||||||||||||
| Balance Sheets | ||||||||||||
| (unaudited) | ||||||||||||
| Assets | June 30, 2021 | December 31, 2020 | ||||||||||
| Current assets: | ||||||||||||
| Cash and cash equivalents | $ | 29,858,868 | 3,322,226 | |||||||||
| Accounts receivable, net | 158,837 | 125,790 | ||||||||||
| Inventory, net | 146,879 | 131,378 | ||||||||||
| Other current assets | 868,842 | 284,115 | ||||||||||
| Total current assets | 31,033,426 | 3,863,509 | ||||||||||
| Property and equipment, at cost: | ||||||||||||
| Leasehold improvements | 1,155,332 | 1,155,332 | ||||||||||
| Office equipment | 64,145 | 64,145 | ||||||||||
| Furniture and fixtures | 424,947 | 424,947 | ||||||||||
| Machinery and equipment | 2,242,088 | 2,242,088 | ||||||||||
| Construction in progress | 151,662 | 139,150 | ||||||||||
| 4,038,174 | 4,025,662 | |||||||||||
| Less accumulated depreciation | (2,470,397 | ) | (2,197,868 | ) | ||||||||
| Net property and equipment | 1,567,777 | 1,827,794 | ||||||||||
| Long-term assets: | ||||||||||||
| Lease right-of-use assets, net | 854,817 | 1,057,506 | ||||||||||
| Intangible assets, net of accumulated amortization | 42,185 | 65,069 | ||||||||||
| Other long-term assets | 488,961 | 792,440 | ||||||||||
| Total long-term assets | 1,385,963 | 1,915,015 | ||||||||||
| Total assets | $ | 33,987,166 | 7,606,318 | |||||||||
| (continued) | ||||||||||||
| FEMASYS INC. | ||||||||||||
| Balance Sheets | ||||||||||||
| (unaudited) | ||||||||||||
| Liabilities, Redeemable Preferred Stock and Stockholders’ Equity (Deficit) | June 30, 2021 | December 31, 2020 | ||||||||||
| Current liabilities: | ||||||||||||
| Accounts payable | $ | 947,078 | 674,333 | |||||||||
| Accrued expenses | 430,183 | 1,117,601 | ||||||||||
| Clinical holdback – current portion | 18,947 | — | ||||||||||
| Notes payable – current portion | 470,556 | 630,010 | ||||||||||
| Lease liabilities – current portion | 419,333 | 434,072 | ||||||||||
| Other – current | 32,895 | 32,895 | ||||||||||
| Total current liabilities | 2,318,992 | 2,888,911 | ||||||||||
| Long-term liabilities: | ||||||||||||
| Clinical holdback – long-term portion | 151,958 | 164,972 | ||||||||||
| Note payable – long-term portion | — | 182,490 | ||||||||||
| Lease liabilities – long-term portion | 603,616 | 809,092 | ||||||||||
| Other – long-term | 32,895 | 32,895 | ||||||||||
| Total long-term liabilities | 788,469 | 1,189,449 | ||||||||||
| Total liabilities | 3,107,461 | 4,078,360 | ||||||||||
| Commitments and contingencies (Note 4) | ||||||||||||
| Redeemable convertible preferred stock: | ||||||||||||
| Preferred stock, Series B, $.001 par, none authorized, issued | ||||||||||||
| and outstanding as of June 30, 2021; 13,344,349 shares | ||||||||||||
| authorized, issued and outstanding as of December 31, 2020 | — | 10,748,873 | ||||||||||
| Preferred stock, Series C, $.001 par, none authorized, issued | ||||||||||||
| and outstanding as of June 30, 2021; 42,491,484 shares | ||||||||||||
| authorized, issued and outstanding as of December 31, 2020 | — | 44,594,813 | ||||||||||
| Stockholders’ equity (deficit): | ||||||||||||
| Common stock, $.001 par, 200,000,000 authorized, | ||||||||||||
| 11,916,943 shares issued and 11,799,720 outstanding as of | ||||||||||||
| June 30, 2021; and 95,583,558 authorized, 1,110,347 shares | ||||||||||||
| issued and 993,124 outstanding as of December 31, 2020 | 11,916 | 1,110 | ||||||||||
| Treasury stock, 117,223 shares | (60,000 | ) | (60,000 | ) | ||||||||
| Preferred stock, Series A, $.001 par, none authorized, issued | ||||||||||||
| and outstanding as of June 30, 2021; 17,310,609 shares | ||||||||||||
| authorized, and 17,210,609 shares issued and outstanding | ||||||||||||
| as of December 31, 2020 | — | 17,211 | ||||||||||
| Warrants | 702,492 | 702,492 | ||||||||||
| Additional paid-in-capital | 108,341,078 | 22,725,949 | ||||||||||
| Accumulated deficit | (78,115,781 | ) | (75,202,490 | ) | ||||||||
| Total stockholders’ equity (deficit) | 30,879,705 | (51,815,728 | ) | |||||||||
| Total liabilities, redeemable convertible preferred stock | ||||||||||||
| and stockholders’ equity (deficit) | $ | 33,987,166 | 7,606,318 | |||||||||
| FEMASYS INC. | ||||||||||||||||||
| Statements of Comprehensive Loss | ||||||||||||||||||
| (unaudited) | ||||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||||
| Sales | $ | 326,006 | 183,234 | 655,781 | 443,746 | |||||||||||||
| Cost of sales | 107,627 | 55,275 | 200,669 | 128,463 | ||||||||||||||
| Gross margin | 218,379 | 127,959 | 455,112 | 315,283 | ||||||||||||||
| Operating expenses: | ||||||||||||||||||
| Research and development | 894,868 | 888,701 | 1,889,890 | 2,239,402 | ||||||||||||||
| Sales and marketing | 21,828 | 13,384 | 44,647 | 250,573 | ||||||||||||||
| General and administrative | 1,051,399 | 543,625 | 1,943,386 | 1,193,817 | ||||||||||||||
| Depreciation and amortization | 151,359 | 165,882 | 304,812 | 335,292 | ||||||||||||||
| Total operating expenses | 2,119,454 | 1,611,592 | 4,182,735 | 4,019,084 | ||||||||||||||
| Loss from operations | (1,901,075 | ) | (1,483,633 | ) | (3,727,623 | ) | (3,703,801 | ) | ||||||||||
| Other income (expense): | ||||||||||||||||||
| Interest income, net | 144 | 1,620 | 308 | 21,956 | ||||||||||||||
| Other income | 821,515 | — | 821,515 | — | ||||||||||||||
| Interest expense | (3,643 | ) | (3,438 | ) | (7,491 | ) | (5,333 | ) | ||||||||||
| Total other income (expense) | 818,016 | (1,818 | ) | 814,332 | 16,623 | |||||||||||||
| Loss before income taxes | (1,083,059 | ) | (1,485,451 | ) | (2,913,291 | ) | (3,687,178 | ) | ||||||||||
| Income tax expense | — | — | — | — | ||||||||||||||
| Net loss | $ | (1,083,059 | ) | (1,485,451 | ) | (2,913,291 | ) | (3,687,178 | ) | |||||||||
| Comprehensive loss: | ||||||||||||||||||
| Net loss | $ | (1,083,059 | ) | (1,485,451 | ) | (2,913,291 | ) | (3,687,178 | ) | |||||||||
| Change in fair value of available for sale investments | — | — | — | (20 | ) | |||||||||||||
| Total comprehensive loss | $ | (1,083,059 | ) | (1,485,451 | ) | (2,913,291 | ) | (3,687,198 | ) | |||||||||
| Net loss attributable to common stockholders, basic and diluted | $ | (1,083,059 | ) | (1,485,451 | ) | (2,913,291 | ) | (3,687,178 | ) | |||||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.52 | ) | (1.55 | ) | (1.89 | ) | (3.86 | ) | |||||||||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 2,076,516 | 955,279 | 1,538,780 | 955,279 | ||||||||||||||
