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Correspondence 0001493152-23-026665 from Evofem Biosciences, Inc. (EVFM) (CIK 0001618835) (EVFM)

Evofem Biosciences, Inc. (EVFM) (CIK 0001618835)
Date: Aug. 3, 2023 · CIK: 0001618835 · Accession: 0001493152-23-026665

AI Filing Summary & Sentiment

File numbers found in text: 333-273185

Referenced dates: July 19, 2023

Date
Aug. 3, 2023
Author
PROCOPIO
Form
CORRESP
Company
Evofem Biosciences, Inc. (EVFM) (CIK 0001618835)

Letter

PROCOPIO

High Bluff Drive

Suite 400

San Diego, CA 92130

T. 858.720.6300

F. 619.235.0398

DEL MAR HEIGHTS

Las Vegas

Orange County

PHOENIX

SAN DIEGO

SILICON VALLEY

Washington DC

August 3, 2023

Via EDGAR

Securities and Exchange Commission

Division of Corporation Finance

Office of Real Estate & Construction

F Street, N.E.

Washington, D.C. 20549-3720

Attention: Lauren Hamill

Alan Campbell

Re: Evofem Biosciences, Inc.

Draft Registration Statement on Form S-1

Filed on July 10, 2023

File No. 333-273185

Ladies and Gentlemen:

On behalf of our client, Evofem Biosciences, Inc. (the “Company”), we submit this letter in response to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in its letter dated July 19, 2023, relating to the Company’s Registration Statement on Form S-1 filed via EDGAR on July 19, 2023 (“Registration Statement”). We are concurrently filing via EDGAR this letter and the Company’s Amendment No. 1 to Registration Statement on Form S-1 (“Amendment No. 1”).

In this letter, we have recited the comments from the Staff in italicized, bold type and have followed each comment with the Company’s response. Except for page references appearing in the headings and comments of the Staff below (which are references to Statement on Form S-1 submitted on July 10, 2023), or as otherwise specifically indicated, all page references herein correspond to the pages of Amendment No. 1.

Securities and Exchange Commission

August 3, 2023

Page 2 of 4

Registration Statement on Form S-1 filed July 10, 2023

Cover Page

1. Consistent with your disclosure beginning on page 12 and elsewhere throughout the prospectus, please revise your cover page to state that (i) you are currently in default on certain financial obligations; (ii) you have considered and continue to consider filing for bankruptcy protection and (iii) if true, holders of your common stock will likely receive no recovery in the event that you file for bankruptcy.

In response to the Staff’s comment, the Company has revised its disclosures on the Cover Page to state the following:

The registrant is currently in default on certain financial obligations. The Company has considered and continues to consider filing for bankruptcy protection. In the event that the Company files for bankruptcy, holders of our common stock, including stock reserved for the Notes and the Warrants being registered for resale in this prospectus, will likely receive no recovery.

Prospectus Summary, page 1

2. Please revise your Prospectus Summary to include a prominent discussion regarding your potential bankruptcy and your current liquidity position. In your revisions, please discuss:

● The Company’s cash position as of the most recent practicable date.

● Your receipt of a Notice of Default on the Baker Bros. Purchase Agreement and the aggregate amounts that are or may be owed pursuant to this agreement.

● The fact that you are over 90 days past due on a significant amount of vendor obligations, including the aggregate amount of your current indebtedness and accounts payable.

● The effect of a potential bankruptcy filing on the holders of your common stock, including investors in this offering.

● Whether investors could lose their entire investment in your company if you do not raise sufficient proceeds to pay your liabilities.

In response to the Staff’s comment, the Company has revised its disclosures in the Prospectus Summary and elsewhere on the cover page and page 12 of the risk factors:

1) (Page 1: Prospectus Summary, Company Overview, paragraph 2) As of August 3, 2023, we had $0.3 million in restricted and unrestricted cash.

2) (Page 1: Prospectus Summary, Company Overview, paragraph 2) As noted in the discussion of risk factors later in this document, we received a Notice of Default on the Baker Bros. Purchase Agreement. As of June 30, 2023, we owe $95.7 million, in aggregate, under this agreement.

Securities and Exchange Commission

August 3, 2023

Page 3 of 4

3) (Page 1: Prospectus Summary, Company Overview, paragraph 3) Additionally, we are currently over 90 days past due on a significant amount of vendor obligations. Our current indebtedness and accounts payable to these vendors is approximately $15.7 million, in aggregate, as of June 30, 2023.

4) (Cover, Page 1: Prospectus Summary, Company Overview, paragraph 4, Page 12, and Page 13) Given our current financial condition, we have considered and continue to consider filing for bankruptcy protection. While we have not initiated bankruptcy proceedings, we caution that trading in our securities is highly speculative and poses substantial risks relating to the potential of bankruptcy proceedings. Trading prices for our securities may bear little or no relationship to the actual recovery, if any, by holders of our securities in Bankruptcy proceedings, if any.

5) (Page 1: Prospectus Summary, Company Overview, paragraph 3) If we are unable to refinance, extend or repay our substantial indebtedness owed to our secured and unsecured lenders, this would have a material adverse effect on our financial condition and ability to continue as a going concern and could cause investors to lose their entire investment in the Company.

3. Please also prominently revise your disclosure in your Prospectus Summary as follows:

● Include a discussion regarding your company’s recurring operating losses and negative cash flows from operating activities since inception. Your disclosure should describe the potential consequences to your business if you are unable to raise additional financing.

● Disclose that proceeds raised in subsequent financings may be required to be used to redeem outstanding debt and would not be ultimately be able to be used to fund your ongoing operations.

● Disclose that you have not paid your Fiscal Year 2023 PDUFA Invoice to the FDA and describe the consequences to your business if this amount remains unpaid. To the extent that failure to pay this amount could affect the approval status of Phexxi,

please so state.

In response to the Staff’s comment, the Company has revised its disclosures in the Prospectus Summary to read as follows:

1) (Page 1: Prospectus Summary, Company Overview, paragraph 2) While we have increased annual net sales of Phexxi year over year since launch, we have not yet reached cash flow breakeven; we continue to incur operating losses and negative cash flows from operating activities, as we have done since inception… If we are unable to raise additional capital to finance our operations when needed or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our business initiatives.

2) (Page 1: Prospectus Summary, Company Overview, paragraph 2) Additionally, we may be required to utilize proceeds of subsequent financings to redeem outstanding debt, in which case we would not be able to use such funds to support our ongoing operations.

3) (Page 2: Prospectus Summary, Company Overview, Phexxi as a Contraceptive; Commercial Strategies, paragraph 12) We have not paid our Fiscal Year 2023 PDUFA Invoice for Phexxi to the FDA. The balance due continues to incur interest and penalties. As a result, any drug application or supplement we submit will be considered incomplete and will not be accepted for consideration for filing until all fees, interest and penalties are paid. We are unable to determine the full impact of this non-payment on the Company.

***

Securities and Exchange Commission

August 3, 2023

Page 4 of 4

Please direct any questions regarding the Company’s responses or Amendment No. 1 to the Registration Statement to me at (858) 720-6322 or dennis.doucette@procopio.com.

Sincerely,
PROCOPIO,
CORY, HARGREAVES & SAVITCH LLP

Show Raw Text
CORRESP
1
filename1.htm

    PROCOPIO

    12544
    High Bluff Drive

    Suite 400

    San Diego, CA 92130

    T.
    858.720.6300

    F. 619.235.0398

    DEL
                                            MAR HEIGHTS

    Las
    Vegas

    Orange
    County

    PHOENIX

    SAN
    DIEGO

    SILICON
    VALLEY

    Washington
    DC

August
3, 2023

Via
EDGAR

    Securities
                                            and Exchange Commission

    Division
    of Corporation Finance

    Office
    of Real Estate & Construction

    100
    F Street, N.E.

    Washington,
    D.C. 20549-3720

Attention: Lauren
                                            Hamill

Alan
Campbell

Re: Evofem
                                            Biosciences, Inc.

Draft
Registration Statement on Form S-1

Filed
on July 10, 2023

File
No. 333-273185

Ladies
and Gentlemen:

On
behalf of our client, Evofem Biosciences, Inc. (the “Company”), we submit this letter in response to comments from
the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained
in its letter dated July 19, 2023, relating to the Company’s Registration Statement on Form S-1 filed via EDGAR on July 19, 2023
(“Registration Statement”). We are concurrently filing via EDGAR this letter and the Company’s Amendment No.
1 to Registration Statement on Form S-1 (“Amendment No. 1”).

In
this letter, we have recited the comments from the Staff in italicized, bold type and have followed each comment with the Company’s
response. Except for page references appearing in the headings and comments of the Staff below (which are references to Statement on
Form S-1 submitted on July 10, 2023), or as otherwise specifically indicated, all page references herein correspond to the pages of Amendment
No. 1.

Securities
and Exchange Commission

August
3, 2023

Page
2 of 4

Registration
Statement on Form S-1 filed July 10, 2023

Cover
Page

    1.
    Consistent
    with your disclosure beginning on page 12 and elsewhere throughout the prospectus, please revise your cover page to state that (i)
    you are currently in default on certain financial obligations; (ii) you have considered and continue to consider filing for bankruptcy
    protection and (iii) if true, holders of your common stock will likely receive no recovery in the event that you file for bankruptcy.

In
response to the Staff’s comment, the Company has revised its disclosures on the Cover Page to state the following:

The
registrant is currently in default on certain financial obligations. The Company has considered and continues to consider filing for
bankruptcy protection. In the event that the Company files for bankruptcy, holders of our common stock, including stock reserved for
the Notes and the Warrants being registered for resale in this prospectus, will likely receive no recovery.

Prospectus
Summary, page 1

    2.
    Please
                                            revise your Prospectus Summary to include a prominent discussion regarding your potential
                                            bankruptcy and your current liquidity position. In your revisions, please discuss:

    ●
    The Company’s cash position as of the most recent practicable date.

    ●
Your receipt of a Notice of Default on the Baker Bros. Purchase Agreement and the aggregate amounts that are or may be owed pursuant
to this agreement.

    ●
    The fact that you are over 90 days past due on a significant amount of vendor obligations, including the aggregate amount of your
    current indebtedness and accounts payable.

    ●
    The effect of a potential bankruptcy filing on the holders of your common stock, including investors in this offering.

    ●
    Whether investors could lose their entire investment in your company if you do not raise sufficient proceeds to pay your liabilities.

In
response to the Staff’s comment, the Company has revised its disclosures in the Prospectus Summary and elsewhere on the cover page
and page 12 of the risk factors:

 1) (Page
                                            1: Prospectus Summary, Company Overview, paragraph 2) As of August 3, 2023, we had
                                            $0.3 million in restricted and unrestricted cash.

 2) (Page
                                            1: Prospectus Summary, Company Overview, paragraph 2) As noted in the discussion of risk
                                            factors later in this document, we received a Notice of Default on the Baker Bros. Purchase
                                            Agreement. As of June 30, 2023, we owe $95.7 million, in aggregate, under this agreement.

Securities
and Exchange Commission

August
3, 2023

Page
3 of 4

 3) (Page
                                            1: Prospectus Summary, Company Overview, paragraph 3) Additionally, we are currently over
                                            90 days past due on a significant amount of vendor obligations. Our current indebtedness
                                            and accounts payable to these vendors is approximately $15.7 million, in aggregate, as of
                                            June 30, 2023.

 4) (Cover,
                                            Page 1: Prospectus Summary, Company Overview, paragraph 4, Page 12, and Page 13) Given
                                            our current financial condition, we have considered and continue to consider filing for bankruptcy
                                            protection. While we have not initiated bankruptcy proceedings, we caution that trading in
                                            our securities is highly speculative and poses substantial risks relating to the potential
                                            of bankruptcy proceedings. Trading prices for our securities may bear little or no relationship
                                            to the actual recovery, if any, by holders of our securities in Bankruptcy proceedings, if
                                            any.

 5) (Page
                                            1: Prospectus Summary, Company Overview, paragraph 3) If we are unable to refinance, extend
                                            or repay our substantial indebtedness owed to our secured and unsecured lenders, this would
                                            have a material adverse effect on our financial condition and ability to continue as a going
                                            concern and could cause investors to lose their entire investment in the Company.

    3.
    Please
                                            also prominently revise your disclosure in your Prospectus Summary as follows:

    ●
    Include a discussion regarding your company’s recurring operating losses and negative cash flows from operating activities
    since inception. Your disclosure should describe the potential consequences to your business if you are unable to raise additional
    financing.

    ●
    Disclose that proceeds raised in subsequent financings may be required to be used to redeem outstanding debt and would not be ultimately
    be able to be used to fund your ongoing operations.

    ●
    Disclose that you have not paid your Fiscal Year 2023 PDUFA Invoice to the FDA and describe the consequences to your business if
    this amount remains unpaid. To the extent that failure to pay this amount could affect the approval status of Phexxi,

    please
    so state.

In
response to the Staff’s comment, the Company has revised its disclosures in the Prospectus Summary to read as follows:

 1) (Page
                                            1: Prospectus Summary, Company Overview, paragraph 2) While we have increased annual net
                                            sales of Phexxi year over year since launch, we have not yet reached cash flow breakeven;
                                            we continue to incur operating losses and negative cash flows from operating activities,
                                            as we have done since inception… If we are unable to raise additional capital to finance
                                            our operations when needed or on acceptable terms, we may be forced to delay, reduce and/or
                                            eliminate one or more of our business initiatives.

 2) (Page
                                            1: Prospectus Summary, Company Overview, paragraph 2) Additionally, we may be required to
                                            utilize proceeds of subsequent financings to redeem outstanding debt, in which case we would
                                            not be able to use such funds to support our ongoing operations.

  3)
  (Page 2: Prospectus Summary, Company Overview, Phexxi as a
Contraceptive; Commercial Strategies, paragraph 12) We have not paid our Fiscal Year 2023 PDUFA Invoice for Phexxi to the FDA. The balance
due continues to incur interest and penalties. As a result, any drug application or supplement we submit will be considered incomplete
and will not be accepted for consideration for filing until all fees, interest and penalties are paid. We are unable to determine the
full impact of this non-payment on the Company.

***

Securities
and Exchange Commission

August
3, 2023

Page
4 of 4

Please
direct any questions regarding the Company’s responses or Amendment No. 1 to the Registration Statement to me at (858) 720-6322
or dennis.doucette@procopio.com.

    Sincerely,

    PROCOPIO,
    CORY, HARGREAVES & SAVITCH LLP

    /s/
    Dennis Doucette, Esq.

    Dennis
    Doucette, Esq.

    cc:
    Saundra
    Pelletier, Evofem Biosciences, Inc.

    Amy
    Raskopf, Evofem Biosciences, Inc.