Company accelerated commercialization with significant new partnerships both in the U.S. and Europe
ATLANTA, Nov. 12, 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 quarter ended September 30, 2024 and provides a corporate update.
Corporate Highlights from 3Q 2024 to date
Announced partnership with Boston IVF, prominent network of fertility centers, to offer FemaSeed®
Announced the onboarding of the first infertility medical clinic customers to offer FemaSeed infertility treatment to patients in California and Florida
Announced strategic distribution partnerships for CE-marked products, including FemaSeed and FemVue® in Spain, which are anticipated to generate over $1.3 million over the next year
Received second order from Spain strategic distribution partners after successfully completing commercial FemaSeed infertility treatments
Received 510(k) clearance from FDA for FemChec®, an innovative diagnostic solution for fallopian tube check
Received CE Mark certification and product approval from Health Canada, the Public Health Agency of Canada, for our compact, eco-friendly FemVue MINI for fallopian tube assessment
Announced issuance of U.S. patent covering FemBloc® device for female permanent birth control
“We continue to achieve significant commercial milestones with regard to our FemaSeed first-line infertility treatment and its supporting FemVue product. Notably, in 3Q we began commercialization of FemaSeed in the U.S., including a high-profile conglomerate, as well as in Europe with two partners in Spain. We look forward to collaborating with our expanding group of partners as we bring our next generation advancements to women,” said Femasys’ CEO Kathy Lee-Sepsick.
Financial Results for Quarter Ended September 30, 2024
Sales increased by $310,547, or 127.1%, to $554,908 in Q3 of 2024 from $244,361 in Q3 of 2023, due to increased sales of FemaSeed and FemVue. The Company recorded its first FemaSeed U.S. and international sales for the three months ended September 30, 2024, and additional sales are expected in the 4th quarter of 2024.
Research and development expenses increased by $230,411, or 11.1%, to $2,303,241 in Q3 of 2024 from $2,072,830 in Q3 of 2023.
Net loss was $5,408,860, or ($0.24) per basic and diluted share attributable to common stockholders, for the quarter ended September 30, 2024, compared to net loss of $3,996,905, or ($0.26) per basic and diluted share attributable to common stockholders, for the quarter ended September 30, 2023.
Cash and cash equivalents as of September 30, 2024, was $7.6 million and the Company had an accumulated deficit of $122.1 million. The Company expects, based on its current operating plan, that its existing cash and cash equivalents will be sufficient to fund its ongoing operations into July 2025.
Financial Results for Nine Months Ended September 30, 2024
Sales increased by $188,673, or 22.0%, to $1,047,532 for the nine months of 2024, from $858,859 for the nine months of 2023 due to increased sales of FemaSeed and FemVue.
R&D expenses increased by $912,406 or 17.8%, to $6,049,847 for the nine months of 2024, from $5,137,441 for the nine months of 2023.
Net loss was $13,692,944, or ($0.62) per basic and diluted share attributable to common stockholders, for the nine-month period ended September 30, 2024, compared to net loss of $9,836,670, or ($0.74) per basic and diluted share attributable to common stockholders, for the same period ended September 30, 2023.
For more information, please refer to the Company’s Form 10-Q filed November 12, 2024, which can be accessed on the SEC website.
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FEMASYS INC. |
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Condensed Balance Sheets |
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(unaudited) |
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Assets |
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September 30, |
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December 31, |
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Current assets: |
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Cash and cash equivalents |
$ |
7,611,210 |
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21,716,077 |
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Accounts receivable, net |
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378,290 |
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98,906 |
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Inventory, net |
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1,937,670 |
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667,118 |
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Prepaid and other current assets |
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1,370,523 |
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695,879 |
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Total current assets |
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11,297,693 |
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23,177,980 |
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Property and equipment, at cost: |
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Leasehold improvements |
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1,238,886 |
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1,212,417 |
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Office equipment |
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67,231 |
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47,308 |
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Furniture and fixtures |
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433,584 |
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414,303 |
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Machinery and equipment |
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2,848,833 |
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2,559,356 |
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Construction in progress |
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548,149 |
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423,077 |
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5,136,683 |
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4,656,461 |
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Less accumulated depreciation |
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(3,748,393 |
) |
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(3,545,422 |
) |
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Net property and equipment |
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1,388,290 |
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1,111,039 |
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Long-term assets: |
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Lease right-of-use assets, net |
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1,941,624 |
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2,380,225 |
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Intangible assets, net of accumulated amortization |
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70,064 |
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— |
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Other long-term assets |
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887,410 |
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1,086,581 |
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Total long-term assets |
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2,899,098 |
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3,466,806 |
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Total assets |
$ |
15,585,081 |
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27,755,825 |
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(continued) |
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FEMASYS INC. |
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Condensed Balance Sheets |
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(unaudited) |
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Liabilities and Stockholders’ Equity |
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September 30, |
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December 31, |
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Current liabilities: |
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Accounts payable |
$ |
1,121,873 |
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1,137,823 |
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Accrued expenses |
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1,127,645 |
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1,444,296 |
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Clinical holdback – current portion |
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92,170 |
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65,300 |
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Lease liabilities – current portion |
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525,752 |
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406,636 |
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Total current liabilities |
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2,867,440 |
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3,054,055 |
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Long-term liabilities: |
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Clinical holdback – long-term portion |
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36,081 |
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54,935 |
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Convertible notes payable, net (including related parties) |
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5,068,556 |
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4,258,179 |
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Lease liabilities – long-term portion |
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1,643,217 |
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2,036,067 |
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Total long-term liabilities |
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6,747,854 |
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6,349,181 |
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Total liabilities |
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9,615,294 |
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9,403,236 |
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Commitments and contingencies |
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Stockholders’ equity: |
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Common stock, $.001 par, 200,000,000 authorized, |
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22,350,022 shares issued and 22,232,799 outstanding as of |
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September 30, 2024; and 21,774,604 shares issued |
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and 21,657,381 outstanding as of December 31, 2023 |
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22,350 |
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21,775 |
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Treasury stock, 117,223 common shares |
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(60,000 |
) |
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(60,000 |
) |
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Warrants |
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2,608,642 |
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2,787,137 |
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Additional paid-in-capital |
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125,473,368 |
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123,985,306 |
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Accumulated deficit |
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(122,074,573 |
) |
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(108,381,629 |
) |
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Total stockholders’ equity |
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5,969,787 |
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18,352,589 |
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Total liabilities and stockholders’ equity |
$ |
15,585,081 |
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27,755,825 |
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FEMASYS INC. |
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Condensed Statements of Comprehensive Loss |
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(unaudited) |
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2024 |
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2023 |
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2024 |
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2023 |
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Sales |
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$ |
554,908 |
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244,361 |
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1,047,532 |
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858,859 |
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Cost of sales (excluding depreciation expense) |
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190,839 |
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86,186 |
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352,496 |
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301,775 |
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Operating expenses: |
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Research and development |
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2,303,241 |
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2,072,830 |
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6,049,847 |
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5,137,441 |
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Sales and marketing |
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1,572,189 |
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70,883 |
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2,847,866 |
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444,678 |
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General and administrative |
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1,530,791 |
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1,970,408 |
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4,645,412 |
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4,642,182 |
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Depreciation and amortization |
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76,288 |
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125,318 |
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215,144 |
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391,683 |
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Total operating expenses |
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5,482,509 |
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4,239,439 |
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13,758,269 |
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10,615,984 |
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Loss from operations |
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(5,118,440 |
) |
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(4,081,264 |
) |
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(13,063,233 |
) |
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(10,058,900 |
) |
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Other income (expense): |
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Interest income |
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124,028 |
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92,392 |
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532,850 |
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232,133 |
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Interest expense |
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(413,290 |
) |
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(8,033 |
) |
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(1,163,153 |
) |
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(9,903 |
) |
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Total other income (expense), net |
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(289,262 |
) |
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84,359 |
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(630,303 |
) |
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222,230 |
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Loss before income taxes |
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(5,407,702 |
) |
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(3,996,905 |
) |
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(13,693,536 |
) |
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(9,836,670 |
) |
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Income tax expense (benefit) |
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1,158 |
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— |
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(592 |
) |
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— |
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Net loss |
$ |
(5,408,860 |
) |
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(3,996,905 |
) |
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(13,692,944 |
) |
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(9,836,670 |
) |
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Net loss attributable to common stockholders, basic and diluted |
$ |
(5,408,860 |
) |
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(3,996,905 |
) |
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(13,692,944 |
) |
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(9,836,670 |
) |
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Net loss per share attributable to common stockholders, basic and diluted |
$ |
(0.24 |
) |
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(0.26 |
) |
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(0.62 |
) |
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(0.74 |
) |
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Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted |
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22,232,799 |
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15,093,147 |
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|
22,075,135 |
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13,369,462 |
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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. 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 and Europe. 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. The Company has developed diagnostic products that are complementary for which it has achieved regulatory approvals to market in the U.S., Canada, Europe, and other ex-U.S. territories, and which are commercial-ready due to its in-house manufacturing capabilities. Its diagnostic products include FemVue® and FemVue® Mini 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,” “suggests,” “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, our ability to establish, maintain, grow or increase sales and revenues, 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, 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:
Matt Blazei
[email protected]
Media:
Kati Waldenburg
[email protected]
This article was originally published here.
