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(State or other jurisdiction of incorporation)
|
(Commission File Number)
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(IRS Employer Identification No.)
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||
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(Address of principal executive offices)
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(Zip Code)
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Title of each class
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Trading
Symbol(s)
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Name of each exchange
on which registered
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| Item 2.02 |
Results of Operations and Financial Condition.
|
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Item 9.01
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Financial Statements and Exhibits.
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Exhibit
No.
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Description
|
|
Press Release of Femasys Inc. dated November 14, 2023
|
|
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL Document)
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|
Femasys Inc.
|
||
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By:
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/s/ Kathy Lee-Sepsick
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|
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Names: Kathy Lee-Sepsick
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||
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Title: Chief Executive Officer
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||
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Date: November 14, 2023
|
||
| • |
In October, Femasys announced that it successfully completed the Stage 2 European Union (EU) Medical Device Regulation (MDR 2017/745) onsite audit resulting in zero nonconformances and no
findings. This is the final audit phase in the MDR designation process that was conducted by TUV SUD America Inc., a recognized Auditing Organization and Notified Body. Successful completion of both Stage 1 and Stage 2 MDR audits confirms
Femasys is compliant in all areas of MDR and may progress to issuance of the MDR certification, allowing for Femasys’ products to secure CE Marking.
|
| • |
In October, Femasys announced that it successfully completed the annual Medical Device Single Audit Program (MDSAP) surveillance audit with no nonconformances and no findings. This satisfies the
relevant harmonized regulatory requirements for the countries participating in the MDSAP program, and ISO 13485 Quality System Certification for the commercialization of Femasys products in the U.S., Canada and Japan with the ability to
register for market authorization in Australia and Brazil.
|
| • |
In September, Femasys announced that it has activated enrollment for its landmark, pivotal FemBloc trial at its first academic site located in Brooklyn, New York. The “FINALE” (FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control) trial is being conducted to investigate the safety and efficacy of its investigational permanent birth
control candidate, FemBloc®, a first-of-its-kind, non-surgical, non-implant, in-office solution for permanent birth control for women. The FDA-cleared, multi-center pivotal trial is designed to address the high unmet need that
exists for women seeking permanent birth control for whom elective surgery remains the only option.
|
| • |
In September, Femasys announced it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for FemaSeed®, an innovative infertility treatment designed
to deliver sperm directly to where conception occurs in a woman’s fallopian tube. In recent decades, infertility has affected an increasing number of women – estimated at 10 million in the United States according to the Center for Disease
Control (CDC). Despite incremental advancements, there have been no recent, meaningful, affordable options. FemaSeed® Intratubal Insemination is a type of artificial insemination that is less invasive than in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI), and therefore is expected to reduce the risk of procedural complications.
|
| • |
In September, Femasys announced the achievement of First-Patient-In for its landmark, pivotal FINALE clinical trial.
The trial continues to enroll patients and additional clinical sites are planned to support its further expansion. FemBloc is intended to be a safer option for women and its cost is estimated to be
substantially less than the long-standing surgical alternative by eliminating the need for anesthesia, incisions, and permanent implants.
|
| • |
In August, Femasys announced that it has obtained a Medical Device Establishment License (“MDEL”) from Health Canada (License Number 24825). The MDEL license is issued by Health Canada’s Regulatory
Operations and Enforcement Branch (ROEB) to companies for the activities of manufacturing, importing and distributing and selling of medical devices for human use in Canada. This license allows Femasys to directly sell its four products,
FemaSeed, FemVue®, FemCath® and FemCerv®, in Canada.
|
| • |
In August, Femasys announced the initiation of enrollment in the “FINALE” trial, a prospective, multicenter pivotal trial to investigate the safety
and efficacy of its investigational permanent birth control candidate, FemBloc.
|
| • |
In July, Femasys announced that the United States Patent and Trademark Office (“USPTO”) issued a Notice of Allowance for U.S. Patent Application
16/402,193, further strengthening Femasys’ intellectual property position and coverage for the Company’s therapeutic product candidate, FemBloc permanent birth control. Femasys expects the resulting patent, when issued, will have an
anticipated expiration in 2039, at the earliest.
|
| • |
In October, Femasys regained compliance with Nasdaq’s minimum bid price requirement, after having received a notice on June 1, 2023 from Nasdaq that they were not in compliance with such
requirement. Femasys is now in compliance with all applicable Nasdaq listing standards.
|
| • |
Research & Development expenses increased by $424,670 to
$2,072,830 for the three months ended September 30, 2023 compared to $1,648,160 for the same period in 2022. The increase relates primarily to increased material and development costs, compensation, and professional and outside consultant
costs, partially offset by reduced clinical-related costs.
|
| • |
General and administrative expenses increased by $575,345 to
$1,970,408 for the three months ended September 30, 2023 compared to $1,395,063 for the same period in 2022. The increase was largely due to increased compensation and professional costs, partially offset by decreased facility and
overhead costs.
|
| • |
Sales decreased by $103,095 to $244,361 for the three
months ended September 30, 2023 compared to $347,456 for the same period in 2022. The decrease was attributable to reduced international and U.S. sales of $45,281 and $57,814, respectively, for the comparable periods. U.S. units sold
decreased by 18.4% for the comparable periods.
|
| • |
Sales and marketing expenses decreased by $19,491 to $70,883
for the three months ended September 30, 2023 compared to $90,374 for the same period in 2022. The decrease was largely due to reduced compensation costs for the comparable three-month period.
|
| • |
Cost of sales decreased by $45,265 to $86,186 for the three
months ended September 30, 2023 compared to $131,451 for the same period in 2022. The decrease was primarily attributed to reduced sales and certain manufacturing efficiencies. Gross margin percentage improved to 64.7% for the three
months ended September 30, 2023 as compared to 62.2% for the three months ended September 30, 2022.
|
| • |
Net loss was $3,996,905 or
$0.26 per basic and diluted share attributable to common stockholders, primarily reflecting the factors noted above, for the three months ended September 30, 2023, compared to $2,982,843, or $0.25 per basic and diluted share attributable
to common stockholders, for the same period last year.
|
| • |
Cash and cash equivalents were $8,692,435 as of September
30, 2023, and Femasys had an accumulated deficit of $103,971,175. Based on the Company’s current operating plan, and the recent additional $11.3 million in immediate capital from the recent
warrant exercises and sale of shares under its at-the-market facility, Femasys’ existing cash and cash equivalents are expected to be sufficient to fund its ongoing operations for at least 12 months.
|
| • |
Research and development expenses increased by $595,294 to
$5,137,441 for the nine months ended September 30, 2023 from $4,542,147 for the same period in 2022. The increase relates primarily to increased material and development costs, compensation, and professional and outside consultant costs,
partially offset by reduced clinical-related costs.
|
| • |
General and administrative expenses increased by $617,826 to
$4,642,182 for the nine months ended September 30, 2023 compared to $4,024,356 for the same period in 2022. The increase was largely due to increased compensation and professional costs, partially offset by decreased facility and other
overhead costs.
|
| • |
Sales decreased by $113,115 to $858,859 for the nine months
ended September 30, 2023 compared to $971,974 for the nine months for the same period in 2022. The decrease was attributable to reduced international and U.S. sales of $57,814 and $55,301, respectively for the comparable periods. U.S.
units sold decreased by 8.6% for the comparable periods.
|
| • |
Sales and marketing expenses increased by $222,264 to
$444,678 for the nine months ended September 30, 2023 compared to $222,414 for the same period in 2022, largely due to increased compensation and related personnel costs and marketing costs to promote the Company’s commercial efforts.
|
| • |
Cost of sales decreased by $54,704 to $301,775 for the nine
months ended September 30, 2023 compared to $356,479 for the same period in 2022. The decrease was primarily attributed to reduced sales and certain manufacturing efficiencies. Gross margin
percentage improved to 64.9% for the nine months ended September 30, 2023 as compared to 63.3% for the nine months ended September 30, 2022.
|
| • |
Net loss was $9,836,670, or
$0.74 per basic and diluted share attributable to common stockholders, primarily reflecting the factors noted above, for the nine-month-period ended September 30, 2023, compared to $8,499,974, or $0.72 per basic and diluted share
attributable to common stockholders, for the same period last year.
|
|
Assets
|
September 30, 2023
|
December 31, 2022
|
||||||
|
Current assets:
|
||||||||
|
Cash and cash equivalents
|
$
|
8,692,435
|
12,961,936
|
|||||
|
Accounts receivable, net
|
103,556
|
77,470
|
||||||
|
Inventory, net
|
602,668
|
436,723
|
||||||
|
Other current assets
|
826,373
|
655,362
|
||||||
|
Total current assets
|
10,225,032
|
14,131,491
|
||||||
|
Property and equipment, at cost:
|
||||||||
|
Leasehold improvements
|
1,195,637
|
1,195,637
|
||||||
|
Office equipment
|
99,344
|
99,344
|
||||||
|
Furniture and fixtures
|
419,303
|
419,303
|
||||||
|
Machinery and equipment
|
2,645,609
|
2,572,243
|
||||||
|
Construction in progress
|
394,957
|
413,843
|
||||||
|
4,754,850
|
4,700,370
|
|||||||
|
Less accumulated depreciation
|
(3,594,300
|
)
|
(3,217,319
|
)
|
||||
|
Net property and equipment
|
1,160,550
|
1,483,051
|
||||||
|
Long-term assets:
|
||||||||
|
Lease right-of-use assets, net
|
2,530,571
|
319,557
|
||||||
|
Intangible assets, net of accumulated amortization
|
388
|
3,294
|
||||||
|
Other long-term assets
|
936,996
|
958,177
|
||||||
|
Total long-term assets
|
3,467,955
|
1,281,028
|
||||||
|
Total assets
|
$
|
14,853,537
|
16,895,570
|
|||||
|
(continued)
|
||||||||
|
Liabilities and Stockholders’ Equity
|
September 30, 2023
|
December 31, 2022
|
||||||
|
Current liabilities:
|
||||||||
|
Accounts payable
|
$
|
851,877
|
510,758
|
|||||
|
Accrued expenses
|
569,442
|
456,714
|
||||||
|
Note payable
|
283,334
|
141,298
|
||||||
|
Clinical holdback – current portion
|
72,075
|
45,206
|
||||||
|
Lease liabilities – current portion
|
410,219
|
373,833
|
||||||
|
Total current liabilities
|
2,186,947
|
1,527,809
|
||||||
|
Long-term liabilities:
|
||||||||
|
Clinical holdback – long-term portion
|
54,019
|
96,658
|
||||||
|
Lease liabilities – long-term portion
|
2,168,969
|
28,584
|
||||||
|
Total long-term liabilities
|
2,222,988
|
125,242
|
||||||
|
Total liabilities
|
4,409,935
|
1,653,051
|
||||||
|
Commitments and contingencies
|
||||||||
|
Stockholders’ equity:
|
||||||||
|
Common stock, $.001 par, 200,000,000 authorized, 16,110,092 shares issued and 15,992,869 outstanding as of September 30, 2023; and
11,986,927 shares issued and 11,869,704 outstanding as of December 31, 2022
|
16,110
|
11,987
|
||||||
|
Treasury stock, 117,223 shares
|
(60,000
|
)
|
(60,000
|
)
|
||||
|
Warrants
|
1,581,608
|
567,972
|
||||||
|
Additional paid-in-capital
|
112,877,059
|
108,857,065
|
||||||
|
Accumulated deficit
|
(103,971,175
|
)
|
(94,134,505
|
)
|
||||
|
Total stockholders’ equity
|
10,443,602
|
15,242,519
|
||||||
|
Total liabilities and stockholders' equity
|
$
|
14,853,537
|
16,895,570
|
|||||
|
Three Months Ended September 30,
|
Nine Months Ended September 30,
|
|||||||||||||||
|
2023
|
2022
|
2023
|
2022
|
|||||||||||||
|
$
|
244,361
|
347,456
|
858,859
|
971,974
|
||||||||||||
|
Sales
|
86,186
|
131,451
|
301,775
|
356,479
|
||||||||||||
|
Cost of sales
|
158,175
|
216,005
|
557,084
|
615,495
|
||||||||||||
|
Gross margin
|
||||||||||||||||
|
Operating expenses:
|
2,072,830
|
1,648,160
|
5,137,441
|
4,542,147
|
||||||||||||
|
Research and development
|
70,883
|
90,374
|
444,678
|
222,414
|
||||||||||||
|
Sales and marketing
|
1,970,408
|
1,395,063
|
4,642,182
|
4,024,356
|
||||||||||||
|
General and administrative
|
125,318
|
139,597
|
391,683
|
426,480
|
||||||||||||
|
Depreciation and amortization
|
4,239,439
|
3,273,194
|
10,615,984
|
9,215,397
|
||||||||||||
|
Total operating expenses
|
(4,081,264
|
)
|
(3,057,189
|
)
|
(10,058,900
|
)
|
(8,599,902
|
)
|
||||||||
|
Loss from operations
|
||||||||||||||||
|
Other income (expense):
|
||||||||||||||||
|
Interest income
|
92,392
|
80,373
|
232,133
|
109,572
|
||||||||||||
|
Interest expense
|
(8,033
|
)
|
(6,005
|
)
|
(9,903
|
)
|
(9,622
|
)
|
||||||||
|
Other expense
|
—
|
(22
|
)
|
—
|
(22
|
)
|
||||||||||
|
Other income (expense), net
|
84,359
|
74,346
|
222,230
|
99,928
|
||||||||||||
|
Net loss
|
$
|
(3,996,905
|
)
|
(2,982,843
|
)
|
(9,836,670
|
)
|
(8,499,974
|
)
|
|||||||
|
Net loss attributable to common stockholders, basic and diluted
|
$
|
(3,996,905
|
)
|
(2,982,843
|
)
|
(9,836,670
|
)
|
(8,499,974
|
)
|
|||||||
|
Net loss per share attributable to common stockholders, basic and diluted
|
$
|
(0.26
|
)
|
(0.25
|
)
|
(0.74
|
)
|
(0.72
|
)
|
|||||||
|
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted
|
15,093,147
|
11,813,610
|
13,369,462
|
11,810,289
|
||||||||||||
Document and Entity Information |
Nov. 14, 2023 |
|---|---|
| Cover [Abstract] | |
| Document Type | 8-K |
| Amendment Flag | false |
| Document Period End Date | Nov. 14, 2023 |
| Entity File Number | 001-40492 |
| Entity Registrant Name | Femasys Inc. |
| Entity Central Index Key | 0001339005 |
| Entity Incorporation, State or Country Code | DE |
| Entity Tax Identification Number | 11-3713499 |
| Entity Address, Address Line One | 3950 Johns Creek Court |
| Entity Address, Address Line Two | Suite 100 |
| Entity Address, City or Town | Suwanee |
| Entity Address, State or Province | GA |
| Entity Address, Postal Zip Code | 30024 |
| City Area Code | 770 |
| Local Phone Number | 500-3910 |
| Title of 12(b) Security | Common Stock, par value $0.001 per share |
| Trading Symbol | FEMY |
| Security Exchange Name | NASDAQ |
| Entity Emerging Growth Company | true |
| Entity Ex Transition Period | true |
| Written Communications | false |
| Soliciting Material | false |
| Pre-commencement Tender Offer | false |
| Pre-commencement Issuer Tender Offer | false |
&PO7W)E;',O=V]R:V)O;VLN>&UL+G)E;'-02P$"% ,4 M " #5.&Y799!YDAD! #/ P $P @ '8$@ 6T-O;G1E C;G1?5'EP97-=+GAM;%!+!08 "0 ) #X" B% ! end