| • |
In February, Dov Elefant was appointed to chief financial officer (CFO). Mr. Elefant has 25 years of financial management experience at both public and private biopharmaceutical companies. He brings a proven
record as a senior level global financial expert with financial reporting, fundraising, and mergers and acquisitions expertise.
|
| • |
In January, Wendy Perrow joined as a new board member. Ms. Perrow brings decades of experience in the life sciences industry related to fundraising, global product launches and corporate strategy.
|
| • |
Femasys expects to complete enrollment for its Stage 2 study of FemBloc in the third quarter of this year and file an IDE for a pivotal trial to support a PMA in the first quarter of next year.
|
| • |
An interim analysis for the FemaSeed LOCAL de novo pivotal trial is planned for the fourth quarter of this year. The trial is being conducted across centers in the
United States and is expected to enroll up to 792 patients who are diagnosed as infertile. The primary endpoints of the study are to determine effectiveness (clinical pregnancy rate) and safety over a period of up to seven weeks. The Company
expects to complete enrollment in the second quarter of next year.
|
| • |
General and administrative expenses increased by $555,368, or 62.3%, to $1,447,355 for the three months ended March 31, 2022 from $891,987 for the three months ended March 31, 2021. The increase was largely due to various additional
costs associated with being a public company, including salaries and related personnel costs due to an increase in headcount, facility, and other allocated overhead costs mainly for additional directors and officers (D&O) insurance,
and increased professional costs for legal and accounting.
|
| • |
Research and development expenses increased by $426,041 or 42.8%, to $1,421,063 for the three months ended March 31, 2022 from $995,022 for the three months ended March 31, 2021. The net increase of $426,041 largely consists of the
$88,245 increase in compensation and related personnel costs primarily due to an increase in headcount, an increase of $270,497 in clinical-related costs associated with our clinical trials, and an increase of $50,707 in professional and
outside consultant costs which are largely attributable to additional consulting costs to support the Company’s clinical trials.
|
| • |
Sales of the Company’s FemVue® product decreased by $8,370, or 2.5%, to $321,405 for the
three months ended March 31, 2022 from $329,775 for the same period last year. The $8,370 decrease was largely attributable to the 4.1% decrease in
U.S. units sold for the three months ended March 31, 2022 as compared to the same period last year. International sales were $58,045 for both the three months ended March 31, 2022 and 2021.
|
| • |
Sales and marketing expenses increased by $46,044 or 201.8%, to $68,863 for the three months ended March 31, 2022 from $22,819 for the three months ended March 31, 2021 largely due to an increase in compensation and related
personnel costs due to an increase in headcount and additional marketing costs associated with our FemVue social media campaign to increase our commercial presence.
|
| • |
Cost of sales increased by $29,633, or 31.8%, to $122,675 for the three months ended March 31, 2022 from $93,042 for the three months ended March 31, 2021. The increase
in cost of sales was largely due to increased labor and overhead costs applied to our cost of sales for the three months ended March 31, 2022 as compared to the same period last year mostly due to production personnel turnover as compared
to the same period last year. As a result, gross margin percentage was 61.8% for the three months ended March 31, 2022 as compared to 71.8% for the three months ended March 31, 2021. The Company stated that it expects to see improvement in
its gross margin in the future after investing in equipment and tooling that will replace and reduce labor in certain manufacturing processes as well as the costs of materials.
|
| • |
Net loss was $2,883,030, or $0.24 per basic and diluted share attributable to common stockholders, primarily reflecting the factors noted above, for the period ended March 31, 2022, compared to $1,830,232, or $1.84 per
basic and diluted share attributable to common stockholders, for the same period ended March 31, 2021.
|
| • |
Cash and cash equivalents as of March 31, 2022 and December 31, 2021, were $21,767,634 and $24,783,029, respectively.
|
|
Assets
|
March 31, 2022
|
December 31, 2021
|
||||||
|
Current assets:
|
||||||||
|
Cash and cash equivalents
|
$
|
21,767,634
|
24,783,029
|
|||||
|
Accounts receivable, net
|
170,302
|
84,258
|
||||||
|
Inventory, net
|
223,008
|
208,270
|
||||||
|
Other current assets
|
567,300
|
555,853
|
||||||
|
Total current assets
|
22,728,244
|
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
|
424,947
|
424,947
|
||||||
|
Machinery and equipment
|
2,287,126
|
2,261,793
|
||||||
|
Construction in progress
|
434,443
|
379,713
|
||||||
|
4,441,497
|
4,321,129
|
|||||||
|
Less accumulated depreciation
|
(2,854,315
|
)
|
(2,722,117
|
)
|
||||
|
Net property and equipment
|
1,587,182
|
1,599,012
|
||||||
|
Long-term assets:
|
||||||||
|
Lease right-of-use assets, net
|
574,943
|
665,747
|
||||||
|
Intangible assets, net of accumulated amortization
|
17,663
|
25,093
|
||||||
|
Other long-term assets
|
625,418
|
655,418
|
||||||
|
Total long-term assets
|
1,218,024
|
1,346,258
|
||||||
|
Total assets
|
$
|
25,533,450
|
28,576,680
|
|||||
|
Liabilities and Stockholders’ Equity
|
March 31, 2022
|
December 31, 2021
|
||||||
|
Current liabilities:
|
||||||||
|
Accounts payable
|
$
|
548,377
|
445,522
|
|||||
|
Accrued expenses
|
565,228
|
603,787
|
||||||
|
Clinical holdback - current portion
|
36,238
|
18,947
|
||||||
|
Note payable – current portion
|
45,666
|
181,123
|
||||||
|
Lease liabilities – current portion
|
400,620
|
406,674
|
||||||
|
Other – current
|
36,037
|
36,037
|
||||||
|
Total current liabilities
|
1,632,166
|
1,692,090
|
||||||
|
Long-term liabilities:
|
||||||||
|
Clinical holdback - long-term portion
|
102,502
|
149,791
|
||||||
|
Lease liabilities – long-term portion
|
305,071
|
402,417
|
||||||
|
Total long-term liabilities
|
407,573
|
552,208
|
||||||
|
Total liabilities
|
2,039,739
|
2,244,298
|
||||||
|
Commitments and contingencies
|
||||||||
|
Stockholders’ equity:
|
||||||||
|
Common stock, $.001 par, 200,000,000 authorized,
11,921,388 shares issued and 11,804,165 outstanding as of
March 31, 2022 and December 31, 2021
|
11,921
|
11,921
|
||||||
|
Treasury stock, 117,223 shares
|
(60,000
|
)
|
(60,000
|
)
|
||||
|
Warrants
|
702,492
|
702,492
|
||||||
|
Additional paid-in-capital
|
108,462,663
|
108,418,304
|
||||||
|
Accumulated deficit
|
(85,623,365
|
)
|
(82,740,335
|
)
|
||||
|
Total stockholders’ equity
|
23,493,711
|
26,332,382
|
||||||
|
Total liabilities and stockholders' equity
|
$
|
25,533,450
|
28,576,680
|
|||||
|
Three Months Ended March 31,
|
||||||||
|
2022
|
2021
|
|||||||
|
Sales
|
$
|
321,405
|
329,775
|
|||||
|
Cost of sales
|
122,675
|
93,042
|
||||||
|
Gross margin
|
198,730
|
236,733
|
||||||
|
Operating expenses:
|
||||||||
|
Research and development
|
1,421,063
|
995,022
|
||||||
|
Sales and marketing
|
68,863
|
22,819
|
||||||
|
General and administrative
|
1,447,355
|
891,987
|
||||||
|
Depreciation and amortization
|
144,199
|
153,453
|
||||||
|
Total operating expenses
|
3,081,480
|
2,063,281
|
||||||
|
Loss from operations
|
(2,882,750
|
)
|
(1,826,548
|
)
|
||||
|
Other income (expense):
|
||||||||
|
Interest income, net
|
2,454
|
164
|
||||||
|
Interest expense
|
(2,734
|
)
|
(3,848
|
)
|
||||
|
Other expense, net
|
(280
|
)
|
(3,684
|
)
|
||||
|
Net loss
|
$
|
(2,883,030
|
)
|
(1,830,232
|
)
|
|||
|
Net loss attributable to common stockholders, basic and diluted
|
$
|
(2,883,030
|
)
|
(1,830,232
|
)
|
|||
|
Net loss per share attributable to common stockholders, basic and diluted
|
$
|
(0.24
|
)
|
(1.84
|
)
|
|||
|
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted
|
11,804,165
|
995,208
|
||||||