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VERU INC.
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VERU INC.
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VERU INC.
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VERU INC.
Response Received
1 company response(s)
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VERU INC.
Response Received
3 company response(s)
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Company responded
2016-06-21
VERU INC.
References: June 14,
2016 | June 14, 2016
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Company responded
2016-07-18
VERU INC.
References: July 11, 2016 | June 14, 2016
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VERU INC.
Response Received
1 company response(s)
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VERU INC.
Awaiting Response
0 company response(s)
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VERU INC.
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High
SEC wrote to company
2016-07-11
VERU INC.
References: June 14, 2016
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VERU INC.
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VERU INC.
Response Received
1 company response(s)
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VERU INC.
Awaiting Response
0 company response(s)
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VERU INC.
Response Received
1 company response(s)
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Company responded
2010-04-01
VERU INC.
References: March 11, 2010 | March 30, 2010
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VERU INC.
Response Received
1 company response(s)
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Company responded
2010-03-11
VERU INC.
References: February 25, 2010
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VERU INC.
Awaiting Response
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VERU INC.
Awaiting Response
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VERU INC.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2008-02-20
VERU INC.
References: February 11, 2008
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VERU INC.
Response Received
1 company response(s)
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VERU INC.
Awaiting Response
0 company response(s)
Medium
VERU INC.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2005-06-23
VERU INC.
References: May 24, 2005
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VERU INC.
Response Received
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-04-13 | SEC Comment Letter | VERU INC. | WI | 333-294909 | Read Filing View |
| 2026-04-13 | Company Response | VERU INC. | WI | N/A | Read Filing View |
| 2026-04-13 | Company Response | VERU INC. | WI | N/A | Read Filing View |
| 2026-04-13 | SEC Comment Letter | VERU INC. | WI | 333-294911 | Read Filing View |
| 2023-05-22 | Company Response | VERU INC. | WI | N/A | Read Filing View |
| 2023-05-19 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2023-04-13 | Company Response | VERU INC. | WI | N/A | Read Filing View |
| 2023-03-31 | Company Response | VERU INC. | WI | N/A | Read Filing View |
| 2023-03-27 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2020-06-30 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2020-06-30 | Company Response | VERU INC. | WI | N/A | Read Filing View |
| 2016-08-05 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2016-07-18 | Company Response | VERU INC. | WI | N/A | Read Filing View |
| 2016-07-11 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2016-06-21 | Company Response | VERU INC. | WI | N/A | Read Filing View |
| 2016-06-14 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2015-09-03 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2015-09-01 | Company Response | VERU INC. | WI | N/A | Read Filing View |
| 2015-08-20 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2010-04-06 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2010-04-01 | Company Response | VERU INC. | WI | N/A | Read Filing View |
| 2010-03-30 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2010-03-11 | Company Response | VERU INC. | WI | N/A | Read Filing View |
| 2010-02-25 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2008-06-13 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2008-03-13 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2008-02-28 | Company Response | VERU INC. | WI | N/A | Read Filing View |
| 2008-02-20 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2008-02-11 | Company Response | VERU INC. | WI | N/A | Read Filing View |
| 2008-01-30 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2005-09-16 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2005-07-07 | Company Response | VERU INC. | WI | N/A | Read Filing View |
| 2005-06-23 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2005-05-24 | Company Response | VERU INC. | WI | N/A | Read Filing View |
| 2005-05-10 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-04-13 | SEC Comment Letter | VERU INC. | WI | 333-294909 | Read Filing View |
| 2026-04-13 | SEC Comment Letter | VERU INC. | WI | 333-294911 | Read Filing View |
| 2023-05-19 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2023-03-27 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2020-06-30 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2016-08-05 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2016-07-11 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2016-06-14 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2015-09-03 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2015-08-20 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2010-04-06 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2010-03-30 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2010-02-25 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2008-06-13 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2008-03-13 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2008-02-20 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2008-01-30 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2005-09-16 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2005-06-23 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| 2005-05-10 | SEC Comment Letter | VERU INC. | WI | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-04-13 | Company Response | VERU INC. | WI | N/A | Read Filing View |
| 2026-04-13 | Company Response | VERU INC. | WI | N/A | Read Filing View |
| 2023-05-22 | Company Response | VERU INC. | WI | N/A | Read Filing View |
| 2023-04-13 | Company Response | VERU INC. | WI | N/A | Read Filing View |
| 2023-03-31 | Company Response | VERU INC. | WI | N/A | Read Filing View |
| 2020-06-30 | Company Response | VERU INC. | WI | N/A | Read Filing View |
| 2016-07-18 | Company Response | VERU INC. | WI | N/A | Read Filing View |
| 2016-06-21 | Company Response | VERU INC. | WI | N/A | Read Filing View |
| 2015-09-01 | Company Response | VERU INC. | WI | N/A | Read Filing View |
| 2010-04-01 | Company Response | VERU INC. | WI | N/A | Read Filing View |
| 2010-03-11 | Company Response | VERU INC. | WI | N/A | Read Filing View |
| 2008-02-28 | Company Response | VERU INC. | WI | N/A | Read Filing View |
| 2008-02-11 | Company Response | VERU INC. | WI | N/A | Read Filing View |
| 2005-07-07 | Company Response | VERU INC. | WI | N/A | Read Filing View |
| 2005-05-24 | Company Response | VERU INC. | WI | N/A | Read Filing View |
2026-04-13 - UPLOAD - VERU INC. File: 333-294909
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 13, 2026 Mitchell Steiner Chief Executive Officer Veru Inc. 2916 N. Miami Avenue Suite 1000 Miami, FL 33127 Re: Veru Inc. Registration Statement on Form S-3 Filed April 7, 2026 File No. 333-294909 Dear Mitchell Steiner: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Lauren Hamill at 303-844-1008 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Benjamin Lombard </TEXT> </DOCUMENT>
2026-04-13 - CORRESP - VERU INC.
CORRESP 1 filename1.htm CORRESP VERU INC. 2916 N. Miami Avenue Suite 1000 Miami, Florida 33127 April 13, 2026 SENT VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Ladies and Gentlemen: Re: Veru Inc. Registration Statement on Form S-3 (File No. 333-294911) Filed on April 7, 2026 In accordance with Rule 461 under the Securities Act of 1933, as amended, on behalf of Veru Inc., the undersigned respectfully requests that the effective date of the above-referenced Registration Statement be accelerated so that the same will become effective at 4:00 p.m. (Eastern Time) on April 15, 2026, or as soon as practicable thereafter. Yours very truly, VERU INC. BY /s/ Michele Greco Michele Greco, Chief Financial Officer and Chief Administrative Officer
2026-04-13 - CORRESP - VERU INC.
CORRESP 1 filename1.htm CORRESP VERU INC. 2916 N. Miami Avenue Suite 1000 Miami, Florida 33127 April 13, 2026 SENT VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Ladies and Gentlemen: Re: Veru Inc. Registration Statement on Form S-3 (File No. 333-294909) Filed on April 7, 2026 In accordance with Rule 461 under the Securities Act of 1933, as amended, on behalf of Veru Inc., the undersigned respectfully requests that the effective date of the above-referenced Registration Statement be accelerated so that the same will become effective at 4:00 p.m. (Eastern Time) on April 15, 2026, or as soon as practicable thereafter. Yours very truly, VERU INC. BY /s/ Michele Greco Michele Greco, Chief Financial Officer and Chief Administrative Officer
2026-04-13 - UPLOAD - VERU INC. File: 333-294911
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 13, 2026 Mitchell Steiner Chief Executive Officer Veru Inc. 2916 N. Miami Avenue Suite 1000 Miami, FL 33127 Re: Veru Inc. Registration Statement on Form S-3 Filed April 7, 2026 File No. 333-294911 Dear Mitchell Steiner: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Lauren Hamill at 303-844-1008 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Benjamin Lombard </TEXT> </DOCUMENT>
2023-05-22 - CORRESP - VERU INC.
CORRESP 1 filename1.htm Acceleration Request VERU INC. 2916 N. Miami Avenue Suite 1000 Miami, Florida 33127 May 22, 2023 SENT VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Ladies and Gentlemen: Re: Veru Inc. Registration Statement on Form S-3 (File No. 333-271891) In accordance with Rule 461 under the Securities Act of 1933, as amended, on behalf of Veru Inc., the undersigned respectfully requests that the effective date of the above-referenced Registration Statement be accelerated so that the same will become effective at 4:00 p.m. (Eastern Time) on May 24, 2023 or as soon as practicable thereafter. Yours very truly, VERU INC. BY /s/ Michele Greco Michele Greco, Chief Financial Officer and Chief Administrative Officer
2023-05-19 - UPLOAD - VERU INC.
United States securities and exchange commission logo
May 19, 2023
Mitchell Steiner, M.D.
Chief Executive Officer
Veru Inc.
2916 N. Miami Avenue
Suite 1000
Miami, Florida 33127
Re:Veru Inc.
Registration Statement on Form S-3
Filed May 12, 2023
File No. 333-271891
Dear Mitchell Steiner:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Dillon Hagius at 202-551-7967 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Benjamin G. Lombard
2023-04-13 - CORRESP - VERU INC.
CORRESP 1 filename1.htm Acceleration Request VERU INC. 2916 N. Miami Avenue Suite 1000 Miami, Florida 33127 April 13, 2023 SENT VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Ladies and Gentlemen: Re: Veru Inc. Registration Statement on Form S-3 (File No. 333-270606) In accordance with Rule 461 under the Securities Act of 1933, as amended, on behalf of Veru Inc., the undersigned respectfully requests that the effective date of the above-referenced Registration Statement be accelerated so that the same will become effective at 4:00 p.m. (Eastern Time) on April 14, 2023 or as soon as practicable thereafter. Yours very truly, VERU INC. BY /s/ Michele Greco Michele Greco, Chief Financial Officer and Chief Administrative Officer
2023-03-31 - CORRESP - VERU INC.
CORRESP 1 filename1.htm CORRESP Reinhart Boerner Van Deuren s.c. P.O. Box 2965 Milwaukee, WI 53201-2965 1000 North Water Street Suite 1700 Milwaukee, WI 53202 Telephone: Facsimile: 414-298-8097 reinhartlaw.com March 31, 2023 Benjamin G. Lombard Direct Dial: 414-298-8225 blombard@reinhartlaw.com SENT VIA EDGAR Daniel Crawford United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Response to SEC Staff Comment Letter March 27, 2023 Veru Inc. Form S-3 Filed March 16, 2023 File No. 333-270606 Dear Mr. Crawford: This letter responds to the letter dated March 27, 2023 (the “Comment Letter”), regarding the above referenced filing (as amended from time to time, the “Form S-3 “). Set forth below is the response of Veru Inc. (“Veru” or the “Company”) to the comments of the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission (“the “Commission”) contained in the Comment Letter. For your convenience, the Staff’s comments have been reproduced below in bold-face font. Capitalized terms used but not defined in this response letter have the meanings ascribed to them in the Form S-3. Registration Statement on Form S-3 filed March 16, 2023 Risk Factors, page 3 Comment 1: We note the disclosure in your Form 10-Q for the quarter ended December 31, 2022, which is incorporated by reference in this registration statement, that you “experienced a decrease compared to the prior year period of 99% in FC2 net revenues in the U.S. prescription channel,” which was “primarily due to lower volume from telemedicine customers as a result of business challenges they have been experiencing.” We also note the risk factor on page 4 of the Form S-3 stating that your net revenues from sales of FC2 may not return to past levels and that you are working to restore ordering and utilization patterns in future periods. Milwaukee • Madison • Waukesha • Wausau • Chicago, IL Rockford, IL • Minneapolis, MN • Denver, CO • Phoenix, AZ SENT VIA EDGAR Daniel Crawford March 31, 2023 Page 2 We reference a press release from the California Attorney General dated February 7, 2023, that announced a $15 million settlement against The Pill Club which involves, among other things, allegations of unlawful billing of California’s Medicaid program for large quantities of FC2. To the extent that this matter and resulting settlement agreement is related to your decrease in revenues, please revise your disclosure to discuss, noting the amount of U.S. prescription channel revenue from sales of FC2 that involved The Pill Club. Otherwise, revise your disclosure to discuss the “business challenges” experienced in more detail. Response: The Company was not a party to the settlement against The Pill Club and has limited information regarding the circumstances involving that settlement. As net revenues from sales of FC2 declined in fiscal 2022 and the first quarter of fiscal 2023, the Company identified certain business challenges based on discussions with its telehealth customers, including The Pill Club. Based on discussions with The Pill Club management, the Company understood the business challenges with respect to The Pill Club to have included changes in management, a rebranding (from The Pill Club to Hey Favor Inc. which was subsequently abandoned) and disruptions in marketing spending. The Company became aware of The Pill Club’s settlement with the California Attorney General as a result of the press release issued by the California Attorney General on February 7, 2023. On February 8, 2023, senior management at the Company discussed the California Attorney General settlement with senior management at The Pill Club. The Pill Club denied any wrongdoing. It is important to note that, notwithstanding the statements in the California Attorney General’s press release, California’s allegations against The Pill Club, according to the publicly available Settlement Agreement executed as of January 18, 2023, involved not only billing for FC2 but also billing for emergency contraceptives, improper coding of asynchronous telemedicine visits, and billing for prescriptions sent to California patients by a Texas pharmacy not then-licensed to provide pharmacy services to California patients. Very recently, The Pill Club was past due in paying a recent invoice for approximately $1.3 million. Veru had been making significant efforts to obtain clarity from The Pill Club on when this payment would be made. On March 29, 2023, The Pill Club refused delivery of a shipment of FC2 for which it had previously submitted a binding purchase order and which it was contractually bound to accept. On March 30, 2023, Veru provided written notice to The Pill Club that Veru believed The Pill Club was in default for the past due payment and the refused shipment. If these breaches remain uncured 10 calendar days after the default notice, Veru’s contract with The Pill Club will automatically terminate by its terms. Although the Company cannot be certain about the impact, if any, of The Pill Club’s settlement on the Company’s revenues or financial condition, it will expand the disclosure in the Form S-3 to address risks and uncertainties relating to The Pill Club as set forth on Exhibit A hereto. SENT VIA EDGAR Daniel Crawford March 31, 2023 Page 3 Incorporation by Reference, page 33 Comment 2: We note that your registration statement incorporates by reference your Form 10-K for the fiscal year ended September 30,2022, which in turn incorporates by reference certain Part III information for a definitive proxy statement that you filed on January 27, 2023. Please revise to specifically incorporate by reference this proxy statement. Response: The Company will file an amendment to the Form S-3 revising the section titled “Incorporation by Reference” to specifically incorporate the proxy statement for its 2023 annual meeting by reference as set forth on Exhibit A hereto. Thank you for your consideration of our responses to the Comment Letter and please do not hesitate to contact me at (414) 298-8225 with any questions or comments regarding any of the foregoing. Yours very truly, /s/ Benjamin Lombard Benjamin G. Lombard Exhibit A Comment No. 1 The following section will be added to “About Veru Inc.” after “Our Company” and before “Corporate Information” in Amendment No. 1 to the Form S-3: Recent Developments The Pill Club has historically been our largest telehealth customer for FC2, accounting for 44% of our net revenues (including 58% of our U.S. prescription channel revenue) in fiscal 2022 and 43% of our net revenues (including 57% of our U.S. prescription channel revenue) in fiscal 2021. We sell FC2 to The Pill Club at a wholesale price pursuant to purchase orders received from The Pill Club from time to time. The Pill Club takes title to FC2 and then acts as a distributor of FC2. The Pill Club is solely responsible for its interactions with health care providers and patients (including, without limitation, the conduct of the telehealth physician-patient interactions), pricing of the FC2 products that it distributes, and legal and regulatory compliance. We have no oversight of The Pill Club’s operations. On February 7, 2023, the California Attorney General announced a settlement with The Pill Club over a number of alleged improper actions by The Pill Club, including alleged overbilling for FC2. Notwithstanding the statements in the California Attorney General’s press release, California’s allegations against The Pill Club, according to the publicly available Settlement Agreement executed as of January 18, 2023, involved not only billing related to FC2 but also billing related to emergency contraceptives, improper coding of asynchronous telemedicine visits, and billing for prescriptions sent to California patients by a Texas pharmacy not then-licensed to provide pharmacy services to California patients. While the California Attorney General’s allegations included The Pill Club’s practices with respect to sales of FC2 by The Pill Club, we were not involved in such business practices and no claims against Veru have been made by the California Attorney General. However, to the extent that the settlement adversely affects The Pill Club’s FC2 sales, our business may be adversely affected. As a result of the settlement, The Pill Club has informed us that it expects to modify some of its business practices regarding its sales of FC2 to patients, notwithstanding that The Pill Club did not agree that it had violated any laws in the Settlement Agreement. It is not clear to Veru at this time when such new business model will be in operation in California or in any other states. In addition, the settlement may have damaged The Pill Club’s reputation and may affect The Pill Club’s financial resources to continue large purchases of FC2. Such changes may make it difficult to restore The Pill Club’s ordering patterns in future periods, and as a result net revenues from sales of FC2 may not return to past levels. We also have a concentration of accounts receivable with The Pill Club, which totals $3.9 million as of March 27, 2023, including $1.3 million of accounts receivable that are past due. At this time, Veru is uncertain as to whether or when The Pill Club will pay these amounts to Veru. Veru had been making significant efforts to obtain clarity from The Pill Club on when this payment would be made. On March 29, 2023, The Pill Club refused delivery of a shipment of FC2 for which it had previously submitted a binding purchase order and which it was contractually bound to accept. On March 30, 2023, Veru provided written notice to The Pill Club that Veru believed The Pill Club was in default for the past due payment and the refused shipment. If these breaches remain uncured 10 calendar days after the default notice, Veru’s contract with The Pill Club for the sale of FC2 will automatically terminate by its terms. If The Pill Club’s business and legal issues impair or have impaired its financial condition, it may no longer be able or willing to pay the past due accounts receivable balance and other outstanding invoices on a timely basis or at all, and The Pill Club may not accept delivery of a recent shipment it had contracted to purchase or place new orders for FC2 from Veru. Further, if The Pill Club does not cure its breaches and our contract for the sale of FC2 with The Pill Club terminates, we expect that our revenue from The Pill Club will be substantially reduced or possibly eliminated. It is possible that individual purchases of FC2 could be made by The Pill Club from time to time but any such potential purchases would be outside of the existing contract if that contract terminates. Amendment No. 1 to the Form S-3 will change the Risk Factors section to revise the third risk factor and add a new fourth risk factor as follows: Our net revenues from sales of FC2 may not return to past levels. Net revenues from sales of FC2 have declined significantly in recent periods, particularly in the U.S. prescription channel. Although we are working to restore ordering and utilization patterns in future periods and working to grow our own sales of FC2 through our proprietary telehealth channel, net revenues from sales of FC2 may not return to past levels. Ordering patterns may not rebound or may continue to decline if our distribution partners in the telehealth sector encounter issues, we or our distribution partners are not able or willing to spend sufficient amounts to market and promote FC2, or underlying demand for FC2 decreases. In particular, sales to our largest telehealth customer, The Pill Club, may not return to past levels due to risks that include potential operational challenges of The Pill Club stemming from its settlement with the California Attorney General, potential issues with The Pill Club’s business and financial condition as a result of the effects of such settlement or other reasons, and a potential termination of our contract with The Pill Club due to recent payment and shipment acceptance breaches by The Pill Club. Any failure to attain or sustain sales growth for FC2 in the U.S. market may have a material adverse effect on our results of operations. We are subject to risks relating to the concentration of accounts receivable with The Pill Club. The Pill Club is one of our largest customers, accounting for 44% of our net revenues in fiscal 2022 and 43% of our net revenues in fiscal 2021. We have a concentration of accounts receivable at The Pill Club, with $3.9 million of accounts receivable as of March 27, 2023, including $1.3 million of accounts receivable that are past due. Veru had been making significant efforts to obtain clarity from The Pill Club on when this payment would be made. On March 29, 2023, The Pill Club refused delivery of a shipment of FC2 for which it had previously submitted a binding purchase order and which it was contractually bound to accept. On March 30, 2023, Veru provided written notice to The Pill Club that Veru believed The Pill Club was in default for the past due payment and the refused shipment. If these breaches remain uncured 10 calendar days after the default notice, Veru’s contract with The Pill Club for the sale of FC2 will automatically terminate by its terms. An adverse change in our relationship with The Pill Club, including a termination of our contract with The Pill Club, or in The Pill Club’s business or financial condition following its settlement with the California Attorney General, could result in a delay in payment of, or an inability to pay, its outstanding accounts receivable balance or an inability or unwillingness to place new orders for FC2, any of which could have a material adverse effect on our cash flows and liquidity. Comment No. 2 Amendment No. 1 to the Form S-3 will revise the second paragraph of “Incorporation By Reference” as follows: We incorporate by reference the following Veru Inc. SEC Filings (File No. 001-13602): • our Annual Report on Form 10-K for the year ended September 30, 2022 filed on December 5, 2022; • our Quarterly Report on Form 10-Q for the quarter ended December 31, 2022 filed on February 9, 2023; • our current report on Form 8-K filed on March 14, 2023; • our definitive proxy statement on Schedule 14A filed on January 27, 2023; and • the description of our common stock contained in our registration statement on Form 8-A, filed on September 28, 1990, including any amendments or reports filed for the purpose of updating the description.
2023-03-27 - UPLOAD - VERU INC.
United States securities and exchange commission logo
March 27, 2023
Mitchell Steiner, M.D.
Chairman, President and Chief Executive Officer
Veru Inc.
2916 N. Miami Avenue
Suite 1000
Miami, Florida 33127
Re:Veru Inc.
Registration Statement on Form S-3
Filed March 16, 2023
File No. 333-270606
Dear Mitchell Steiner:
We have limited our review of your registration statement to those issues we have
addressed in our comments. In some of our comments, we may ask you to provide us with
information so we may better understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form S-3 filed March 16, 2023
Risk Factors, page 3
1.We note the disclosure in your Form 10-Q for the quarter ended December 31, 2022,
which is incorporated by reference into this registration statement, that you “experienced a
decrease compared to the prior year period of 99% in FC2 net revenues in the U.S.
prescription channel,” which was “primarily due to lower volume from telemedicine
customers as a result of business challenges they have been experiencing.” We also note
the risk factor on page 4 of the Form S-3 stating that your net revenues from sales of FC2
may not return to past levels and that you are working to restore ordering and utilization
patterns in future periods.
FirstName LastNameMitchell Steiner, M.D.
Comapany NameVeru Inc.
March 27, 2023 Page 2
FirstName LastName
Mitchell Steiner, M.D.
Veru Inc.
March 27, 2023
Page 2
We reference a press release from the California Attorney General dated February 7,
2023, that announced a $15 million settlement against The Pill Club which involves,
among other things, allegations of unlawful billing of California’s Medicaid program for
large quantities of FC2. To the extent that this matter and resulting settlement agreement
is related to your decrease in revenues, please revise your disclosure to discuss, noting the
amount of U.S. prescription channel revenue from sales of FC2 that involved The Pill
Club. Otherwise, revise your disclosure to discuss the "business challenges" experienced
in more detail.
Incorporation by Reference, page 33
2.We note that your registration statement incorporates by reference your Form 10-K for the
fiscal year ended September 30, 2022, which in turn incorporates by reference certain Part
III information from a definitive proxy statement that you filed on January 27, 2023.
Please revise to specifically incorporate by reference this proxy statement.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
Please contact Daniel Crawford at 202-551-7767 or Laura Crotty at 202-551-7614 with
any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Ben Lombard, Esq.
2020-06-30 - UPLOAD - VERU INC.
United States securities and exchange commission logo
June 29, 2020
Mitchell S. Steiner, M.D.
Chairman, President and Chief Executive Officer
Veru Inc.
48 NW 25th Street
Suite 102
Miami, Florida 33127
Re:Veru Inc.
Registration Statement on Form S-3
Filed June 26, 2020
File No. 333-239493
Dear Dr. Steiner:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Tim Buchmiller at (202) 551-3635 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Benjamin G. Lombard, Esq.
2020-06-30 - CORRESP - VERU INC.
CORRESP 1 filename1.htm CORRESP VERU INC. 48 NW 25th Street Suite 102 Miami, Florida 33127 June 30, 2020 SENT VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Ladies and Gentlemen: Re: Veru Inc. Registration Statement on Form S-3 (File No. 333-239493) In accordance with Rule 461 under the Securities Act of 1933, as amended, on behalf of Veru Inc., the undersigned respectfully requests that the effectiveness of the above-referenced Registration Statement be accelerated to 4:00 p.m. (Eastern Time) on July 1, 2020 or as soon as practicable thereafter. Yours very truly, VERU INC. BY /s/ Michele Greco Michele Greco, Chief Financial Officer and Chief Administrative Officer
2016-08-05 - UPLOAD - VERU INC.
August 5 , 2016
Mr. O.B. Parrish
Chairman and Chief Executive Officer
The Female Health Company
515 N. State Street, Suite 2225
Chicago, IL 60654
Re: Female Health Co.
Preliminary Proxy Statement on Schedule 14A
Filed May 18, 2016
File No. 001-13602
Dear Mr. Parish :
We completed our review of your filing on July 26, 2016. We remind you that our
comments or changes to disclosure in response to our comments do not foreclose the
Commission from taking any action with respect to the company or the filing and the company
may not assert staff comments as a defense in any proceeding initiated by the Commission or any
person under the federal securities laws of the United States. We urge all persons who are
responsible for the acc uracy and adequacy of the disclosure in the filing to be certain that the
filing includes the information the Securities Exchange Act of 1934 and all applicable rules
require.
Sincerely,
/s/ Pamela A. Long
Pamela A. Long
Assistant Director
Office of Manufacturing and
Construction
2016-07-18 - CORRESP - VERU INC.
CORRESP 1 filename1.htm CORRESP Reinhart Boerner Van Deuren s.c. P.O. Box 2965 Milwaukee, WI 53201-2965 1000 North Water Street Suite 1700 Milwaukee, WI 53202 Telephone: 414-298-1000 Facsimile: 414-298-8097 reinhartlaw.com July 18, 2016 James M. Bedore Direct Dial: 414-298-8196 jbedore@reinhartlaw.com SENT VIA EDGAR Pamela A. Long, Assistant Director United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Response to SEC Staff Comment Letter dated July 11, 2016 The Female Health Company Revised Preliminary Proxy Statement on Schedule 14A Filed June 21, 2016 File No. 001-13602 Dear Ms. Long: On behalf of The Female Health Company (“FHC” or the “Company”), this letter responds to your letter dated July 11, 2016 (the “Comment Letter”), regarding the above referenced filing (as amended from time to time, the “Proxy Statement”), relating to the proposed transaction between the Company and Aspen Park Pharmaceuticals, Inc. (“Aspen Park”). A revised preliminary proxy statement (the “Revised Proxy Statement”) is being filed electronically on EDGAR today. For your convenience, FHC has also filed on EDGAR marked copies of the Revised Proxy Statement showing all changes made to the original preliminary proxy statement. Set forth below is FHC’s response to the comment of the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission (“the “Commission”) contained in the Comment Letter. For your convenience, the Staff’s comment has been reproduced below in bold-face font. Capitalized terms used but not defined in this response letter have the meanings ascribed to them in the Proxy Statement. General Comment 1: We note your response to comment 11 of our letter dated June 14, 2016; however, we note that the change in domicile is contingent upon the passage of the other merger-related proposals and, therefore, you do not appear to qualify for the exemption Milwaukee ● Madison ● Waukesha ● Rockford, IL Chicago, IL ● Phoenix, AZ ● Denver, CO Pamela A. Long, Assistant Director July 18, 2016 Page 2 under Rule 145(a)(2) for mergers where the sole purpose of the transaction is to change the issuer’s domicile. In addition, your analysis states that shareholders of FHCO do not have to vote on the APP merger. Please tell us how this is consistent with the by-laws that require a vote of shareholders when more than 20% of your outstanding stock will be issued. Response: As discussed with the staff, the Merger Agreement has been amended to provide that completion of the APP Merger is not conditioned on stockholder approval of the Reincorporation Proposal or completion of the Reincorporation Merger, and the Reincorporation Plan of Merger has been amended to provide that completion of the Reincorporation Merger is not conditioned on stockholder approval of any of the proposals related to the APP Merger or the completion of the APP Merger. As a result, the Reincorporation Merger is completely separate from and independent of the APP Merger and the proposals related to the APP Merger. These changes establish that the Reincorporation Merger is being proposed for the sole purpose of changing FHC’s domicile from Wisconsin to Delaware consistent with the exception under Rule 145(a)(2). If you have any questions or comments or require further information with respect to the foregoing, please do not hesitate to call the undersigned at (414) 298-8196. Yours very truly, /s/ James M. Bedore James M. Bedore 34431167 cc: O.B. Parrish Pamela A. Long, Assistant Director July 18, 2016 Page 3 The undersigned hereby acknowledges on behalf of The Female Health Company that in connection with the Proxy Statement: • the Company is responsible for the adequacy and accuracy of the disclosure in the filing; • staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and • the Company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Dated: July 18, 2016 THE FEMALE HEALTH COMPANY By /s/ O.B. Parrish O.B. Parrish Chairman and Chief Executive Officer
2016-07-11 - UPLOAD - VERU INC.
July 11 , 2016
Mr. O.B. Parrish
Chairman and Chief Executive Officer
The Female Health Company
515 N. State Street, Suite 2225
Chicago, IL 60654
Re: Female Health Co.
Revised Preliminary Proxy Statement on Schedule 14A
Filed June 21 , 2016
File No. 001-13602
Dear Mr. Pa rrish:
We have reviewed your filing an d have the following comments. In some of our
comments, we may ask you to provide us with information so we may better understand your
disclosure.
Please respond to these comments within ten busine ss days by providing the requested
information or advis e us as soon as possible when you will respond. If you do not believe our
comments apply to your facts and circumstances , please tell us why in your response.
After review ing your response to these comments, we may have additional comments.
General
1. We note your response to comment 11 of our letter dated June 14, 2016; however, we
note that the change in domicile is contingent upon the passage of the other mer ger-
related proposals and, therefore, you do not appear to qualify for the exemption under
Rule 145(a)(2) for mergers where the sole purpose of the transaction is to change the
issuer’s domicile . In addition, your analysis states that shareholders of FHCO do not
have to vote on the APP merger. Please tell us how this is consistent with the by -laws
that require a vote of shareholders when more than 20% of your outstanding stock will be
issued.
We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing includes the information the Securities Exchange Act of
1934 and all applicable Exchange Act rules require. Since the company and its management are
in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.
O.B. Parrish
The Female Health Company
July11 , 2016
Page 2
In responding to our comments, please provide a written statement from the company
acknowledging that:
the company is responsible for the adequacy and accuracy of the disclosure in the filing;
staff comments or changes to disclosure in response to staff comments do not foreclose
the Commission from taking any action with respect to the filing; and
the company may not assert staff comments as a defense in any proceeding initiated by
the Commission or any person under the federal securities laws of the United States.
You may contact Melinda Hooker, Staff Accountant, at (202) 551 -3732 or John Cash,
Accou nting Branch Chief, at (202) 551 -3768 if you have questions regarding comments on the
financial statements and re lated matters. Please contact Kate McHale, Staff Attorney, at (202)
551-3464 or me at (202) 551 -3765 with any other questions.
Sincerely,
/s/ Pamela Long
Pamela Long
Assistant Director
Office of Manufacturing and
Construction
cc: James Bedore, Esq.
2016-06-21 - CORRESP - VERU INC.
CORRESP 1 filename1.htm CORRESP Reinhart Boerner Van Deuren s.c. P.O. Box 2965 Milwaukee, WI 53201-2965 1000 North Water Street Suite 1700 Milwaukee, WI 53202 Telephone: 414-298-1000 Facsimile: 414-298-8097 reinhartlaw.com June 21, 2016 James M. Bedore Direct Dial: 414-298-8196 jbedore@reinhartlaw.com SENT VIA EDGAR Pamela A. Long, Assistant Director United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Response to SEC Staff Comment Letter dated June 14, 2016 The Female Health Company Preliminary Proxy Statement on Schedule 14A Filed May 18, 2016 File No. 001-13602 Dear Ms. Long: On behalf of The Female Health Company (“FHC” or the “Company”), this letter responds to your letter dated June 14, 2016 (the “Comment Letter”), regarding the above referenced filing (as amended from time to time, the “Proxy Statement”), relating to the proposed transaction between the Company and Aspen Park Pharmaceuticals, Inc. (“Aspen Park”). A revised preliminary proxy statement (the “Revised Proxy Statement”) is being filed electronically on EDGAR today. For your convenience, FHC has also filed on EDGAR marked copies of the Revised Proxy Statement showing all changes made to the original preliminary proxy statement. Set forth below are FHC’s responses to the comments of the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission (“the “Commission”) contained in the Comment Letter. For your convenience, the Staff’s comments have been reproduced below in bold-face font. Please note that all page numbers in the responses below are references to the page numbers of the Revised Proxy Statement, unless otherwise noted. Capitalized terms used but not defined in this response letter have the meanings ascribed to them in the Proxy Statement. Milwaukee • Madison • Waukesha • Rockford, IL Chicago, IL • Phoenix, AZ • Denver, CO Pamela A. Long, Assistant Director June 21, 2016 Page 2 General Comment 1: Please provide us copies of the Board Books prepared by your financial advisor in connection with this merger. Response: A copy of the Board Book prepared by Torreya in connection with its fairness opinion analysis is being furnished to the Staff under separate cover. This is the only Board Book prepared by Torreya in connection with the transaction. Comment 2: We are unable to locate the financial statements and disclosure required by Item 13 of Schedule 14A. Please provide this information, or tell us how you concluded it is not required. Response: FHC respectfully submits that the disclosure required by Item 13 of Schedule 14A was not included in the Proxy Statement because FHC concluded that it is not material to the exercise of prudent judgment in accordance with Instruction 1 of Item 13. Disclosure is required under Item 13 of Schedule 14A only if action is to be taken on any matter specified in Item 11 or 12. In this case, FHC’s stockholders are being asked to consider a proposal to increase the authorized shares of common stock in order to issue shares to the Aspen Park stockholders in the APP Merger, which is covered by Item 11. This same action also involves an acquisition resulting in disclosure being required under Item 14 of Schedule 14A. Item 13 and Item 14(c)(1) contain overlapping requirements as to financial disclosure regarding FHC as the registrant/acquiring company in this case. Both Item 13 and Item 14 contain instructions permitting the applicable financial information of the acquirer not to be included unless material to the stockholders of the acquirer in their voting decision. Instruction 3 of Item 14 applies where the consideration consists of exempt securities (and/or cash, which is not applicable here) and only security holders of the acquirer are voting in connection with the proxy statement. This instruction recognizes that security holders of the acquirer are presumed to have access to information about their company. See Section 1140.3 of the Division of Corporation Finance’s Financial Reporting Manual. It allows the disclosure to focus on what is material to such security holders, which is financial information about the target company and pro forma financial information. We respectfully submit that the same considerations should apply to the materiality standard in Item 13 of Schedule 14A in this case. FHC’s stockholders are presumed to have access to information about FHC and including additional financial disclosure in the Proxy Statement regarding FHC which is already publicly available on EDGAR will not assist in the exercise of prudent judgment in the matters to be considered by FHC’s stockholders. We also believe that including the Item 13 information will significantly increase the size and complexity of the Proxy Statement and obscure otherwise relevant information. Pamela A. Long, Assistant Director June 21, 2016 Page 3 Comment 3: Please include the information required by Item 8 of Schedule 14A with regard to any officer or director who is anticipated to serve as an officer or director of Veru. Response: The Revised Proxy Statement includes a new section with disclosure regarding compensation on page 79. How will FHC’s stockholders be affected by the Reincorporation Merger and the issuance of shares of Veru Common Stock to Aspen Park’s stockholders in connection with the APP Merger?, page 3. Comment 4: Please include a brief discussion of the change in the state of incorporation and any material changes to the rights of stockholders. Response: Page 4 of the Revised Proxy Statement has been revised to include a brief discussion of the change in FHC’s state of incorporation and material changes to the rights of its stockholders as a result of the change in its state of incorporation. Registration Rights Agreement, page 18 Comment 5: We note your disclosure of your plan to issue shares of Veru to Aspen Park stockholders pursuant to an exemption from registration under federal securities law. Please disclose the specific exemption and the qualifying characteristics of the Aspen shareholders. Response: The issuance of the shares of Veru to the Aspen Park stockholders will be exempt from registration pursuant to Section 4(a)(2) of the Securities Act of 1933 and Rule 506 thereunder. Aspen Park has a total of 18 stockholders, consisting of 17 stockholders who are accredited investors within the meaning of Rule 501(a) and one stockholder who is not an accredited investor but is a former executive officer of Aspen Park and a sophisticated investor. Concurrent with the execution of the Merger Agreement by Aspen Park, each Aspen Park stockholder executed and delivered a written consent approving the Merger Agreement and a representation letter. The representation letters included customary representations regarding the accredited investor status and financial sophistication of each Aspen Park stockholder. Legends will be placed on the shares of Veru common stock issued to the Aspen Park stockholders restricting transfer in accordance with Rule 502(d). Pamela A. Long, Assistant Director June 21, 2016 Page 4 Required Vote, page 45 Comment 6: We note your disclosure on page 3 that several members of your Board are subject to “support agreements;” please disclose in this section the percentage of shares that are subject to a voting agreement and owned by officers and directors that intend to vote for the merger. Response: The Revised Proxy Statement includes disclosure on pages 4, 15 and 104 regarding the total percentage of outstanding shares of FHC common stock that are subject to the support agreements. Background of the Mergers, page 58 Comment 7: Please disclose more detail with regard to why the Company did not pursue transactions with Company A and Company B. Response: The Revised Proxy Statement includes additional disclosure on page 59 as to why discussions with Company A and Company B regarding potential transactions were terminated. Comment 8: We note that you hired a consultant who will be compensated with stock options for participating in the merger negotiations. Please disclose the identity of this consultant and the services provided to the Board. Response: The Revised Proxy Statement on page 59 identifies this consultant and describes the services he provided to FHC. Comment 9: We note that your financial advisor relied on the analysis of FHC and Aspen Park in its valuation of Aspen Park and its determination of fairness. Please include a discussion regarding who from FHC was involved in the valuation and the process they used to value a company with so many products in early stage of development. You state that FHC revised some of the projections offered by Aspen Park; please disclose this process and the reasons behind the revisions. Response: Torreya relied on the financial forecasts of Aspen Park originally prepared by Aspen Park and reviewed and adjusted by FHC. The Revised Proxy Statement on page 66 includes disclosure regarding this process, the revisions to the Aspen Park financial forecast made by FHC and the reasons for such revisions, and the persons from FHC involved in this process. Pamela A. Long, Assistant Director June 21, 2016 Page 5 Opinion of FHC’s Financial Advisor, page 68 Comment 10: Disclosure on page 75 indicates that the transaction fee payable to Torreya is based upon average sales prices for FHC Common Stock on the five trading days prior to the date of the closing of the Mergers. Please clarify, if true, that payment of this fee is contingent upon the closing, and that if the transactions were not to close, Torreya would only be entitled to the $250,000 that was payable upon delivery of its opinion. Response: The Revised Proxy Statement on page 73 clarifies that Torreya’s 4% fee payable in cash and warrants is contingent on the closing of the APP Merger and if the APP Merger does not close, Torreya would only be entitled to the $250,000 fee that was payable upon delivery of its opinion. Restrictions on Sales of Shares of Veru Common Stock Received in the Mergers, page 82 Comment 11: Please provide us with your analysis as to why this transaction does not involve an offer or sale of common stock to your current shareholders under Securities Act Rule 145, given that the transaction on which shareholders are voting includes both the change of domicile of Female Health as well as the acquisition of Aspen. Rule 145(a)(2) excepts statutory mergers from the definition of offer and sale only where the sole purpose of the transaction is to change the issuer’s domicile. Response: FHC respectfully submits that the reincorporation merger is being proposed to FHC’s stockholders solely for the purpose of changing FHC’s domicile from Wisconsin to Delaware, and accordingly fits within the exception in Rule 145(a)(2). Under Wisconsin law, FHC’s stockholders are not required to approve the APP Merger itself or the Merger Agreement. To effect the change in FHC’s domicile, FHC’s stockholders are only required to approve a plan of merger for the Reincorporation Merger. Because FHC stockholders are not required to and are not being asked to approve the APP Merger, the description of Proposal No. 1 in the Revised Proxy Statement has been changed to refer only to the reincorporation merger and a plan of merger for the Reincorporation Merger, and to eliminate all references to approving the APP Merger or the Merger Agreement. These changes clarify that the Reincorporation Merger is separate from the approval of the other matters relating to the APP Merger, which is consistent with the fact that the Reincorporation Merger is being proposed for the sole purpose of changing FHC’s domicile. Certain Aspen Park Projections, page 83 Comment 12: Please remove the last sentence on this page that disclaims responsibility for the information in this section. You may include explanatory language in this section but you may not disclaim your responsibility under the federal securities laws. Pamela A. Long, Assistant Director June 21, 2016 Page 6 Response: The last sentence of the second paragraph under the section entitled “Certain Aspen Park Projections” on page 86 has been deleted in the Revised Proxy Statement. Explanatory Note Regarding the Merger Agreement, page 86 Comment 13: We note your cautionary statements concerning the representations and warranties in the merger agreement. Please note that disclosure regarding an agreement’s representations or covenants in a proxy statement (whether through incorporation by reference or direct inclusion) constitutes a disclosure to investors, and you are required to consider whether additional disclosure is necessary in order to put the information into context so that such information is not misleading. Please refer to Report of Investigation Pursuant to Section 21(a) of the Securities Exchange Act of 1934 and Commission Statement on potential Exchange Act Section 10(b) and Section 14(a) liability, Exchange Act Release No. 51283 (Mar. 1, 2005). Accordingly, if you continue to use these cautionary statements in your proxy statement, please revise them to remove any implication that the merger agreement does not constitute disclosure under the federal securities laws or that shareholders may not rely on this disclosure. In addition, please clarify that you will provide additional disclosure in your public reports to the extent that you are or become aware of the existence of any material facts that are required to be disclosed under federal securities law and that might otherwise contradict the representations and warranties contained in or incorporated into your proxy. Response: The Revised Proxy Statement has been revised to delete language that may imply that stockholders may not rely on the disclosure regarding the Merger Agreement and to state that FHC will provide additional disclosure to the extent it is or becomes aware of the existence of material facts that are required to be disclosed under federal securities law and that might otherwise contradict the representations, warranties or covenants contained in the Merger Agreement. Unaudited Pro Forma Condensed Combined Financial Statements, page 108 Comment 14: We read in paragraph two that the unaudited pro forma condensed combined statements of operations has been prepared assuming the Mergers closed on March 31, 2016. Please revise your statements and introductory paragraph to assume that the merger closed at the beginning of the fiscal year that ended on September 30, 2015. Response: The unaudited pro forma condensed combined statements of operations and introductory paragraph have been revised to assume that the Mergers closed as of October 1, 2014. Pamela A. Long, Assistant Director June 21, 2016 Page 7 Notes to the Unaudited Pro Forma Condensed Combined Financial Statements, page 111 Comment 15: We note that FHC has not begun the valuation process and will allocate the excess purchase price to identifiable tangible and intangible assets and the excess to goodwill once the valuation is complete. Please revise your disclosure to indicate when you expect to commence the valuation process. Response: The Revised Proxy Statement includes disclosure on page 114 of when FHC expects to commence the valuation process for identifiable tangible and intangible assets. Comment 16: We further note that you anticipate the majority of the fair value will be related to in process research and development. Please ensure you disclose the method which you will use to determine the fair value of the in process R&D. Response: The Revised Proxy Statement includes disclosure on page 115 of the method that FHC intends to use to determine the value of in process research and development. Contractual Obligations, page 130 Comment 17
2016-06-14 - UPLOAD - VERU INC.
June 14, 2016
Mr. O.B. Parrish
Chairman and Chief Executive Officer
The Female Health Company
515 N. State Street, Suite 2225
Chicago, IL 60654
Re: Female Health Co.
Preliminary Proxy Statement on Schedule 14A
Filed May 18, 2016
File No. 001-13602
Dear Mr. Parish :
We have reviewed your filing an d have the following comments. In some of our
comments, we may ask you to provide us with information so we may better understand your
disclosure.
Please respond to these comments within ten busine ss days by providing the requested
information or advis e us as soon as possible when you will respond. If you do not believe our
comments apply to your facts and circumstances , please tell us why in your response.
After reviewing your response to these comments, we may have additional comments.
General
1. Please provide us copies of the Board Books prepared by your financial advisor in
connection with this merger.
2. We are unable to locate the financial statements and disclosure required by Item 13 of
Schedule 14A. Please provide this information, or tell us how you concluded it is not
required.
3. Please include the information required by Item 8 of Schedule 14A with regard to any
officer or director who is anticipated to serve as an officer or director of Veru.
How will FHC’s stockholders be affected by the Reincorporation Merger and the issuance of
shares of Veru Common Stock to Aspen Park’s stockholders in connection with the APP
Merger? , page 3
4. Please include a brief discussion of the change in the state of incorporation and any
material changes to the rights of stockholders.
O.B. Parrish
The Female Health Company
June 14, 2016
Page 2
Registration Rights Agreement, page 18
5. We note your disclosure of your plan to issue shares of Veru to Aspen Park sto ckholders
pursuant to an exemption from registration under federal securities law. Please disclose
the specific exemption and the qualifying characteristics of the Aspen shareholders.
Required Vote, page 45
6. We note your disclosure on page 3 that sev eral members of your Board are subject to
“support agreements”; please disclose in this section the percentage of shares that are
subject to a voting agreement and owned by officers and directors that intend to vote for
the merger.
Background of the Merg ers, page 58
7. Please disclose more detail with regard to why the Company did not pursue transactions
with Company A and Company B.
8. We note that you hired a consultant who will be compensated with stock options for
participating in the merger negotiations . Please disclose the identity of this consultant
and the services provided to the Board.
9. We note that your financial advisor relied on the analysis of FHC and Aspen Park in its
valuation of Aspen Park and its determination of fairness. Please include a discussion
regarding who from FHC was involved in the valuation and the process they used to
value a company with so many products in early stage of development. You state that
FHC revised some of the projections offered by Aspen Park; please disclose t his process
and the reasons behind the revisions.
Opinion of FHC’s Financial Advisor, page 68
10. Disclosure on page 73 indicates that the transaction fee payable to Torreya is based upon
average sales prices for FHC Common Stock on the five trading days prior to the date of
the closing of the Mergers. Please clarify, if true, that payment of this fee is contingent
upon the closing, and that if the transactions were not to c lose, Torreya would only be
entitled to the $250,000 that was payable upon delivery of its opinion.
Restrictions on Sales of Shares of Veru Common Stock Received in the Mergers, page 82
11. Please provide us with your analysis as to why this transaction does not involve an offer
or sale of common stock to your current shareholders under Securities Act Rule 145,
given that the transaction on which shareholders are voting includes both the change of
domicile of Female Health as well as the acquisition of Aspen. Rule 145(a)(2) excepts
O.B. Parrish
The Female Health Company
June 14, 2016
Page 3
statutory mergers from the definition of offer and sale only where the sole purpose of the
transaction is to change the issuer’s domicile.
Certain Aspen Park Projections, page 83
12. Please remove the last sentence on this page that disclaims responsibility for the
information in this section. You may include explanatory language in this section but
you may not disclaim your responsibility under the federal securities laws.
Explanatory Note Regarding the Merger Agreement , page 86
13. We note your cautionary statements concerning the representations and warranties in the
merger agreement. Please note that disclosure regarding an agreement’s representations
or covenants in a proxy statement (whether through incorporation by reference o r direct
inclusion) constitutes a disclosure to investors, and you are required to consider whether
additional disclosure is necessary in order to put the information into context so that such
information is not misleading. Please refer to Report of Inves tigation Pursuant to Section
21(a) of the Securities Exchange Act of 1934 and Commission Statement on potential
Exchange Act Section 10(b) and Section 14(a) liability, Exchange Act Release No. 51283
(Mar. 1, 2005). Accordingly, if you continue to use thes e cautionary statements in your
proxy statement, please revise them to remove any implication that the merger agreement
does not constitute disclosure under the federal securities laws or that shareholders may
not rely on this disclosure. In addition, ple ase clarify that you will provide additional
disclosure in your public reports to the extent that you are or become aware of the
existence of any material facts that are required to be disclosed under federal securities
law and that might otherwise contrad ict the representations and warranties contained in or
incorporated into your proxy.
Unaudited Pro Forma Condensed Combined Financial Statements, page 108
14. We read in paragraph two that the unaudited pro forma condensed combined statements
of operations has been prepared assuming the Mergers closed on March 31, 2016. Please
revise your statements and introductory paragraph to assume that the merger closed at the
beginning of the fiscal year that ended on September 30, 2015.
Notes to the Unaudited Pro Fo rma Condensed Combined Financial Statements, page 111
15. We note that FHC has not begun the valuation process and will allocate the excess
purchase price to identifiable tangible and intangible assets and the excess to goodwill
once the valuation is complete . Please revise your disclosure to indicate when you expect
to commence the valuation process.
O.B. Parrish
The Female Health Company
June 14, 2016
Page 4
16. We further note that you anticipate the majority of the fair value will be related to in
process research and development. Please ensure you disclose the meth od which you
will use to determine the fair value of the in process R&D.
Contractual Obligations, page 130
17. Given the substantial change in contractual obligations since year end, please revise your
filing to include a table of contractual obligations at the end of the most recent fiscal
quarter presented in this filing.
We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing includes the information the Securities Exchange Act of
1934 and all applicable Exchange Act rules require. Since the company and its management are
in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of t he disclosures they have made.
In responding to our comments, please provide a written statement from the company
acknowledging that:
the company is responsible for the adequacy and accuracy of the disclosure in the filing;
staff comments or changes to disclosure in response to staff comments do not foreclose
the Commission from taking any action with respect to the filing; and
the company may not assert staff comments as a defense in any proceeding initiated by
the Commission or any person under the federal securities laws of the United States.
You may contact Melinda Hooker, Staff Accountant, at (202) 551 -3732 or John Cash,
Accounting Branch Chief, at (202) 551 -3768 if you have questions regarding comments on the
financial statements and re lated ma tters. Please contact Kate McHale, Staff Attorney, at (202)
551-3464 or me at (202) 551 -3765 with any other questions.
Sincerely,
/s/ Pamela A. Long
Pamela A. Long
Assistant Director
Office of Manufacturing and
Construction
2015-09-03 - UPLOAD - VERU INC.
September 3, 2015 Mail Stop 4631 Via E-mail Ms. Michele Greco, VP and Chief Financial Officer The Female Health Company 515 N. State Street, Suite 2225 Chicago, IL 60654 Re: The Female Health Company Form 10-K for the year ended September 30, 2014 Filed December 2, 2014 File No. 1 -13602 Dear Ms. Greco : We have completed our review of your filing . We remind you that our comments or changes to disclosure in response to our comments do not foreclose the Commission from taking any action with respect to the company or the filing and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities la ws of the United States. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Exchange Act of 1934 and all applicable rules require. Sincerely, /s/ John Cash John Cash Branch Chief Office of Manufacturing and Construction
2015-09-01 - CORRESP - VERU INC.
CORRESP
1
filename1.htm
secresponse.htm
September 1, 2015
SENT VIA EDGAR
Mr. John Cash
Branch Chief
Office of Manufacturing and Construction
United States Securities and Exchange Commission
Division of Corporation Finance
Washington, D.C. 20549
Re:
The Female Health Company
Form 10-K for the year ended September 30, 2014
Filed December 2, 2014
Form 10-Q for the quarter ended June 30, 2015
Filed July 30, 2015
File No. 1-13602
Dear Mr. Cash:
The following are the responses of The Female Health Company (the "Company") to the comments in the letter of the staff of the
Securities and Exchange Commission dated August 20, 2015, relating to the Company's Form 10-K for the year ended September 30,
2014, and Form 10-Q for the quarter ended June 30, 2015. For reference purposes, the text of the staff s comment letter has been
reproduced below with responses below for each numbered paragraph.
Form 10-K for the year ended September, 30, 2014
Consolidated Statements of Cash Flows, page F-8
Comment 1:
We note your non-cash activity of reducing accrued expenses upon issuance of shares. Please tell us what gives rise to this non-cash
transaction and your accounting policy for this activity. Additionally, please revise future periodic filings to clearly disclose your
accounting policy for these transactions.
Response to Comment No. 1:
The non-cash activity related to reducing accrued expenses upon issuance of shares relates to shares awarded to certain employees which
are not issued until a specified future issuance date contingent on continued employment as of such date. When these shares are awarded,
the amount of the award is accrued evenly over the period prior to the issuance date with a corresponding charge to compensation expense.
Upon issuance of the shares, additional paid in capital is increased and the accrued expense is reduced. This results in the non-cash
transaction.
Footnote 7 – Equity and Share Based Payments, to the consolidated financial statements in the Form 10-K contains a description of these
types of stock awards. In future filings, we will expand the description of the accounting policy for share-based compensation in
footnote 1 – Nature of Business and Significant Accounting Policies as follows:
In many instances, the equity awards are issued upon the grant date subject to vesting periods. In certain instances, the equity
awards provide for future issuance contingent on future continued employment as of the issuance date.
Form 10-Q for the quarter ended June 30, 2015
Notes to the Consolidated Financial Statements
Note 1. Basis of Presentation
Restricted Cash, page 8
Comment 2:
We note that restricted cash relates to security provided to one of the Company’s U.K. banks for performance bonds issued in favor of
customers and that you have included restricted cash within your cash balance for presentation on the balance sheet. Please explain
to us how you considered Rule 5-02 of Regulation S-X in determining it was not necessary to present these amounts in a separate
restricted cash line item. Additionally, please tell us what consideration you gave to ASC Topic 230-10-45 in determining your
cash flow presentation of changes in restricted cash.
Response to Comment No. 2:
The details of Restricted Cash are included in footnote 1 – Basis of Presentation to the consolidated financial statements. We considered
Rule 5-02 of Regulation S-X in determining if a separate balance sheet presentation was necessary and concluded that the balance of
restricted cash, which was less than 0.5% of total current assets as of June 30, 2015, was not material, and therefore was not presented
as a separate line item on the balance sheet. The information disclosed in footnote 1 is adequate to highlight the amount of and the
provisions relating to the portion of cash which is restricted. The restricted cash balance is included in the total cash balance and the
change in the balance of the restricted cash is included in the total change in cash and not separately detailed as a component of investing
activities in the cash flow presentation. Separate disclosure as a component of investing activities was not made as it had already been
determined that separate disclosure of the restricted cash was not material.
****
The Company acknowledges that (i) the Company is responsible for the adequacy and accuracy of the disclosure in its filings; (ii) staff
comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect
to the filings; and (iii) the Company may not assert staff comments as a defense in any proceeding initiated by the Commission or any
person under the federal securities laws of the United States.
Please contact me at (312) 595-9742 if you have any questions on any of the responses to your comments.
Regards,
/s/ Michele Greco
Michele Greco
Executive Vice President and Chief Financial Officer
MG:vls
2015-08-20 - UPLOAD - VERU INC.
August 20, 2015 Mail Stop 46 31 Via U.S. Mail Ms. Michele Greco, VP and Chief Financial Officer The Female Health Company 515 N. State Street, Suite 2225 Chicago, IL 60654 Re: The Female Health Company Form 10-K for the year ended September 30, 2014 Filed December 2, 2014 Form 10 -Q for the quarter ended June 30, 2015 Filed July 30, 2015 File No. 1 -13602 Dear Ms. Greco : We have limited our review of your filing to the financial statements and related disclosures and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to these comments within ten busine ss days b y providing the requested information or advis e us as soon as possible when you will respond. If you do not believe our comments apply to your facts and circumstances, please tell us why in your response. After reviewing your response to these comments , we may have additional comments. Form 10 -K for the year ended September, 30, 2014 Consolidated Statements of Cash Flows, page F -8 1. We note your non -cash activity of reducing accrued expenses upon issuance of shares. Please tell us what gi ves rise to this non -cash transaction and your accounting policy for this activity. Additionally, please revise future periodic filings to clearly disclose your accounting policy for these transactions. Ms. Michele Greco The Female Health Company August 20, 2015 Page 2 Form 10 -Q for the quarter ended June 30, 2015 Note s to the Consolidated Financial Statements Note 1. Basis of Presentation Restricted Cash, page 8 2. We note that restricted cash relates to security provided to one of the Company’s U.K. banks for performance bonds issued in favor of customers and that you have included restricted cash within your cash balance for presentation on the balance sheet. Please explain to us how you considered Rule 5 -02 of Regulation S -X in determining it was not necessary to present these amounts in a separate restricted cash line item. Additionally, please tell us what consideration you gave to ASC Topic 230 -10-45 in determ ining your cash flow presentation of changes in restricted cash. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Exchange Act of 1934 and all applica ble Exchange Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of t he disclosures they have made. In respondi ng to our comments, please provide a written statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the filing; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. You may contact Mindy Hooker at (202) 551 -3732 or me at (202) 551 -3768 with any questions. Sincerely, /s/ John Cash John Cash Branch Chief Office of Manufacturing and Construction
2010-04-06 - UPLOAD - VERU INC.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549-4631
DIVISION OF
CORPORATION FINANCE
Mail Stop 4631
April 6, 2010
Ms. Donna Felch The Female Health Company 515 N. State Street, Suite 2225 Chicago, IL
RE: The Female Health Company
Form 10-K for the fiscal year ended September 30, 2009
Filed December 17, 2009
File #1-13602
Dear Ms. Felch:
We have completed our review of your Fo rm 10-K and related filings and have no
further comments at this time.
If you have any questions regarding co mments on the financial statements and
related matters please direct them to Tric ia Armelin, Staff Account ant, at (202) 551-3747,
or, in her absence, to the undersigned at (202) 551-3689. Please contact Dorine Miller,
Financial Analyst, at (202) 551-3711or, in he r absence, Dieter Ki ng, Staff Attorney, at
(202) 551-3338 with any other questions.
S i n c e r e l y , John Hartz Senior Assistant Chief Accountant
2010-04-01 - CORRESP - VERU INC.
CORRESP
1
filename1.htm
corrapril1.htm
April 1, 2010
SENT VIA EDGAR
Mr. John Hartz
Senior Assistant Chief Accountant
United States Securities and Exchange Commission
Division of Corporation Finance
Washington, D.C. 20549
Re: The Female Health Company
Form 10-K for the year ended September 30, 2009
Filed December 17, 2009
File No. 1-13602
Dear Mr. Hartz:
The following are the responses of The Female Health Company (the "Company") to the comments in the letter of the staff of the Securities and Exchange Commission dated March 30, 2010 relating to the Company's Form 10-K for the year ended September 30, 2009 and Form 10-Q for the quarter ended December 31, 2009. For reference purposes, the text of the staff's comment letter has been reproduced below with responses below for each numbered paragraph.
Form 10-K for the fiscal year ended September 30, 2009
Note 6 – Income Taxes, page F-14
Comment No. 1:
We note your response to our prior comment seven. Please revise future filings to include disclosures similar to the information you provided in your response.
Response to Comment No. 1:
In future filings, the Company will include disclosures similar to the information we provided in “Response to comment No. 7” from our response letter dated March 11, 2010.
Form 10-Q for the quarterly period ended December 31, 2009
Note 10 – FC1/FC2 Transition – Restructuring Costs, page 15
Comment No. 2:
We note your response to our prior comment eight and twelve. Please revise future filings to include disclosures similar to the information you provided in your response.
Response to Comment No. 2:
In future filings, the Company will include disclosures similar to the information we provided in “Response to comment No. 8 and No. 12” from our response letter dated March 11, 2010.
* * * *
The Company acknowledges that (i) the Company is responsible for the adequacy and accuracy of the disclosure in its filings; (ii) staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filings; and (iii) the Company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Please contact me at (312) 595-9742 if you have any questions on any of the responses to your comments.
Best regards,
The Female Health Company
/s/ Donna Felch
Donna Felch
Vice President and Chief Financial Officer
2
2010-03-30 - UPLOAD - VERU INC.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549-4631
DIVISION OF
CORPORATION FINANCE
Mail Stop 4631
March 30, 2010
Ms. Donna Felch The Female Health Company 515 N. State Street, Suite 2225 Chicago, IL
RE: The Female Health Company
Form 10-K for the fiscal year ended September 30, 2009
Filed December 17, 2009
File #1-13602
Dear Ms. Felch:
We have reviewed your response lett er dated March 11, 2010 and have the
following additional comments. If you disagree , we will consider your explanation as to
why our comment is inapplicable. In some of our comments, we may ask you to provide
us with supplemental information so we ma y better understand your disclosure. After
reviewing this information, we may or may not raise additional comments.
Form 10-K for the fiscal year ended September 30, 2009
Note 6 - Income Taxes, page F-14
1. We note your response to our prior comment seven. Please revise future filings to
include disclosures similar to the in formation you provided in your response.
Form 10-Q for the quarterly period ended December 31, 2009
Note 10 - FC1/FC2 Transition - Restructuring Costs, page 15
2. We note your responses to our prior comm ents eight and twelve. Please revise
future filings to include disclosures similar to the information you provided in your response.
* * * *
Ms. Donna Felch
The Female Health Company March 30, 2010 Page 2
As appropriate, please respond to these co mments within 10 business days or tell
us when you will provide us with a response. Please furnish a letter that keys your
responses to our comments and provides any requested supplemental information.
Detailed response letters greatly facilitate our review. Please file your response letter on
EDGAR. Please understand that we may have additional comments after reviewing your
responses to our comments.
If you have any questions regarding these comments, please direct them to Tricia
Armelin, Staff Accountant, at (202) 551-3747, Anne McConnell, Senior Accountant, at
(202) 551-3709 or, in their absence, to the undersigned at (202) 551-3689.
S i n c e r e l y , John Hartz Senior Assistant Chief Accountant
2010-03-11 - CORRESP - VERU INC.
CORRESP
1
filename1.htm
fhcmarch112010responsetosec.htm
March 11, 2010
SENT VIA EDGAR
Mr. John Hartz
Senior Assistant Chief Accountant
United States Securities and Exchange Commission
Division of Corporation Finance
Washington, D.C. 20549
Re: The Female Health Company Form 10-K for the year ended September 30, 2009
Filed December 17, 2009
File No. 1-13602
Dear Mr. Hartz:
The following are the responses of The Female Health Company (the "Company") to the comments in the letter of the staff of the Securities and Exchange Commission dated February 25, 2010 relating to the Company's Form 10-K for the year ended September 30, 2009 and Form 10-Q for the quarter ended December 31, 2009. For reference purposes, the text of the staff's comment letter has been reproduced below with responses below for each numbered paragraph.
Form 10-K for the fiscal year ended September 30, 2009
Item 1. Business
Strategy, page 7
Comment 1:
In future filings, please describe your relationship with Hindustan Lifecare Limited in greater detail. Please publicly file any agreements between you and Hindustan Lifecare Limited that are material to your business.
Response to Comment No. 1:
In future filings, the Company will clarify that Hindustan Lifecare Limited (HLL) is authorized to manufacture FC2 at HLL's facility in Kochi, India for sale in India, that HLL is the Company's exclusive distributor in India and that the Company receives a royalty based on the number of units sold by HLL in India. The Company does not believe that its relationship with HLL is material as royalties from HLL constituted less than 1% of the Company's total net revenues in fiscal 2009 and fiscal 2008. As a result, the Company does not believe that its agreement with HLL is material to its business for purposes of Item 601 of Regulation S-K.
Government Regulation, page 10
Comment No. 2:
In future filings, please expand the discussion in the second paragraph to explain what you mean by, "FC2 received PMA as a Class III Medical Device." In doing so, please explain what "PMA" means and explain the significance of this classification.
Response to Comment No. 2:
In future filings, the Company will expand the disclosure regarding government regulation to explain that female condoms as a group were classified by FDA as Class III medical devices in 1989. Class III medical devices are deemed by the FDA to carry potential risks with use which must be tested prior to FDA approval, referred to as Premarket Approval (PMA), for sale in the U.S. As FC2 is a Class III medical device, prior to selling FC2 in the U.S., the Company was required to submit a PMA application containing technical information on the use of FC2 such as pre-clinical and clinical safety and efficacy studies which were gathered together in a required format and content. FC2 received PMA as a Class III medical device from the FDA in March 2009.
Comment No. 3:
In future filings, please expand the discussion in the third paragraph to state whether the company is in compliance with the conditions of the FDA's approval order relating to the company's sales and distribution of the FC2 products.
Response to Comment No. 3:
The conditions of the FDA's approval order relate to product labeling, including information on the package itself and instructions for use called a "package insert" which accompanies each product. In future filings, the Company will expand the disclosure regarding government regulation to discuss these conditions and the Company's compliance with the conditions.
Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations, page 18
Liquidity and Sources of Capital, page 24
Comment No. 4:
We note your statement on page 25 that you believe your "current cash position is adequate to fund operations...in the near future." In future filings, please expand your liquidity discussion to address liquidity on both a long-term and short-term basis. To the extent you can do so, when providing guidance about your liquidity please use more precise periods (e.g., the next 12 months) rather than terms like "in the near future," whose meaning is less clear. Please refer to Item 303(a)(1) of Regulation S-K and Instruction 5 thereto.
2
Response to Comment No. 4:
In future filings, to the extent it can do so, the Company will provide guidance about its liquidity for precise periods, such as the next 12 months.
Comment No. 5:
We note that you have two revolving notes with Heartland Bank. Please revise future filings to discuss the terms and conditions of any significant covenants you are subject to under these notes. In addition, if you are subject to financial covenants, please revise future annual and quarterly filings to present, for the most significant and restrictive covenants, actual ratios and other actual amounts versus the minimum/maximum ratios/amounts required at each reporting date. Such a presentation may allow investors to more easily assess and understand your current status and future ability to meet your covenants. See Sections I.D. and IV.C of the SEC Interpretive Release No. 33-8350.
Response to Comment No. 5:
The Company's credit agreement with Heartland Bank does not contain any financial covenants that require compliance with ratios or amounts. The line of credit consists of a revolving note for up to $500,000 with borrowings limited to 50% of eligible accounts receivable and a revolving note for up to $1,000,000 with borrowings limited to the amount of supporting letters of credit issued by The World Bank or another issuer of equivalent credit quality approved by the Bank. Significant restrictive covenants include prohibitions on any merger, consolidation or sale of all or a substantial portion of the Company's assets and limits on the payment of dividends or the repurchase of shares. Dividends and share repurchases are permitted as long as after giving effect to the dividend or share repurchase the Company has at least $1,000,000 of available cash and a ratio of total liabilities to total stockholders' equity of at least 1:1. In future filings of periodic reports, the Company will expand the disclosure regarding the revolving notes with Heartland Bank to describe these limits on borrowings and the significant restrictive covenants.
Note 1. Nature of Business and Significant Accounting Policies, page F-7
Accounts receivable and concentration of credit risk, page F-7
Comment No. 6:
Please revise future filings to disclose the percentages of sales to significant customers for each period presented. Reference Item 101 of Regulation S-K and ASC 280-10-50-42.
3
Response to Comment No. 6:
In future filings, the Company will identify significant customers (defined as those customers representing greater than 10% of net revenues) and disclose the percentage of sales to each such significant customer for each year presented.
Note 6 – Income Taxes, page F-14
Comment No. 7:
With a view toward future disclosure, please provide us a more specific and comprehensive explanation of how you determined changes in your tax valuation allowance during each period presented. Separately address your ability to utilize U.S. and foreign carry-forwards.
Response to Comment No. 7
We complete a detailed analysis of our deferred income tax valuation allowances on an annual basis or more frequently if information comes to our attention that would indicate that a revision to our estimates is necessary. In evaluating the Company's ability to realize its deferred tax assets, management considers all available positive and negative evidence on a country by country basis, including past operating results and forecast of future taxable income. In determining future taxable income, management makes assumptions to forecast U.S. federal and state, U.K. and Malaysia operating income, the reversal of temporary differences, and the implementation of any feasible and prudent tax planning strategies. These assumptions require significant judgment regarding the forecasts of the future taxable income in each tax jurisdiction, and are consistent with the forecasts used to manage the Company's business. It should be noted that the Company realized significant losses through 2005 on a consolidated basis. The Company has a history of taxable income for three consecutive years in the U.K. and two consecutive years in the U.S., which was used to determine the amount of time we can reasonably expect to generate taxable income in the future. In our analysis to determine the amount of the deferred tax asset to recognize, we projected future taxable income for the subsequent two years for each tax. There is a full valuation allowance on the Malaysia deferred tax asset, as there is not sufficient history of taxable income in that tax jurisdiction.
As of September 30, 2009, the Company had federal and state net operating loss carryforwards of approximately $37,393,000 and $28,224,000, respectively, for income tax purposes expiring in years 2010 to 2028. The Company's U.K. subsidiary has U.K. net operating loss carryforwards of approximately $68,790,000 as of September 30, 2009 which can be carried forward indefinitely to be used to offset future U.K. taxable income. The Company's Malaysian subsidiary has net operating loss carryforwards of approximately $352,000 as of September 30, 2009 which can be carried forward indefinitely to be used to offset future Malaysian taxable income. With the increasing demand for and profitability of the FC2 female condom, the Company expects utilization of its net operating losses in both the U.K. and the U.S. will continue. However, because some of the U.S. federal tax losses have a net loss carryforward limitation of fifteen years, it is possible that some of the Company's early losses carried forward in the U.S. will not be fully utilized. The U.K. net operating losses do not expire. The losses incurred in Malaysia are related to the recent start-up and are expected to be utilized over the next several years.
4
Note 13 – Restructuring Costs, page F-23
`
Comment No. 8:
With a view toward future disclosure, please provide us a more specific and comprehensive discussion of the nature of your restructuring costs. In this regard, please clarify your "redundancy" and "other expenses." Reference ASC 420-10-50. Also, please explain to us how you determined the appropriate time period to accrue the restructuring costs that you recorded in FY 2009 and FY 2010.
Response to Comment No. 8:
To properly identify and recognize the restructuring costs related to manufacturing cessation at its U.K. subsidiary, the Company followed the guidance of Accounting Standards Codification Topic 420, which addresses financial accounting and reporting for costs associated with exit or disposal activities. In connection with the transition from FC1, the Company's first generation Female Condom which was manufactured in its U.K. facility, to FC2, which is manufactured in Malaysia, the Company's customers began switching their orders from FC1 to FC2. In August 2009, the Company announced to its U.K. employees the start of an evaluation process regarding the future of the U.K. manufacturing facility. That process, required by British labor laws, is one in which management and labor representatives work together to determine whether a viable alternative for the manufacturing facility can be identified. In September 2009, the process concluded when management and the labor representatives were unable to identify a viable alternative. In late September, production employees were notified of the redundancy (plan to terminate their employment) and of the one-time termination payments due them, a total of $1,116,911. Manufacturing ceased in mid-October. Following manufacturing cessation, production employees were no longer required to report for work. In compliance with British labor law, the termination payments were made in late November 2009. The liability for the termination payments was properly recognized at the communication date (in September 2009), in accordance with ASC 420-10-25-4. Other related costs were as follows:
Consulting costs
$ 104,247
Inventory write-downs
94,125
Other facility exit costs
181,340
Total
$ 379,713
These other related costs fall under the scope of other associated costs of an exit activity, as suggested by the Interpretive Response in Staff Accounting Bulletin Topic 5(P)(4), including footnote 17. These costs were recognized in the period in which the related cost was incurred in accordance with ASC 420-10-25-15.
5
Normal manufacturing and distribution costs, including materials, labor and overhead, related to the production and selling of product through the cessation date are not a component of the one-time termination payments and were accounted for when incurred rather than included in the restructuring accrual as of September 30, 2009.
Following the decision to cease manufacturing at the U.K. manufacturing facility, the Company negotiated an exit from the lease of the U.K. manufacturing facility during the first quarter of fiscal 2010. The exit took the form of the replacement of the old long-term lease with a new short-term lease in November 2009. Costs included exit fees, consulting regarding the lease exit and negotiation, costs related to the loss of economic benefit offset by proportionate recognition of deferred gain on original sale/leaseback of facility and estimated dilapidation (removal of leasehold improvements) expense.
Lease exit fees and estimated dilapidation costs, both of which are terms of the new lease, were recognized upon its execution in November 2009. As 82% of the leased space is unused and provides no economic benefit following the cessation of manufacturing, the lease cost of the unused space was recognized immediately upon the date use ceased. Recognition of lost economic benefit is required under the guidance of Accounting Standards Codification Topic 420-10-25-11 through 420-10-25-13.
We followed the disclosure guidance provided in ASC 420-10-50-1(a)-(e). Paragraphs 50-1(d) and 50-1(e) are not applicable to our disclosure because the Company has a single reporting segment and there were no unrecognized liabilities because the fair value could not be reasonably estimated.
Item 15. Exhibits and Financial Statement Schedules, page 43
Comment No. 9:
We note from your disclosure in the Management's Discussion and Analysis section that your Heartland Bank credit facility represents a potentially important external source of liquidity for you. Please tell us why you have not filed this credit facility as an exhibit to your annual report on Form 10-K. Please note that if this credit facility is a material contract for purposes of Item 601(b)(10) of Regulation S-K, you should file the credit facility, including all of its schedules and exhibits, with your next periodic report or, if you wish, a current report on Form 8-K.
Response to Comment No. 9:
The Company has not previously filed its credit agreement as an exhibit as it has not historically had borrowings under its line of credit. However, given that the facility is available for future liquidity needs, the Company will file the credit agreement, including all amendments, schedules and exhibits, as a material contract for purposes of Item 601(b)(10) with its next periodic report.
6
Exhibit 31.1 and Exhibit 31.2
Comment No. 10:
We note that you have deleted the language "(the registrant's fourth fiscal quarter in the case of an annual report)" in each of the two certifications required by Rule 13a-14(a) under the Securities Exchange Act of 1934, as amended. In future filings, please use the exact form of the certification specified in Item 601(b)(31) of Regulation S-K. Please refrain from deleting the aforementioned language or
2010-02-25 - UPLOAD - VERU INC.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549-4631
DIVISION OF
CORPORATION FINANCE
Mail Stop 4631
February 25, 2010
Ms. Donna Felch The Female Health Company 515 N. State Street, Suite 2225 Chicago, IL
RE: The Female Health Company
Form 10-K for the fiscal year ended September 30, 2009
Filed December 17, 2009
File #1-13602
Dear Ms. Felch:
We have reviewed your filings and have the following comments. Where
indicated, we think you should re vise your document in response to these comments. If
you disagree, we will consider your explanation as to why our comment is inapplicable or
a revision is unnecessary. Please be as deta iled as necessary in your explanation. In
some of our comments, we may ask you to pr ovide us with supplemental information so
we may better understand your disclosure. Af ter reviewing this information, we may or
may not raise additional comments.
Please understand that the purpose of our re view process is to assist you in your
compliance with the applicable disclosure requirements and to enhance the overall
disclosure in your filing. We look forward to working with you in these respects. We
welcome any questions you may have about our comments or on any other aspect of our
review. Feel free to call us at the telephone numbers listed at the end of this letter.
Form 10-K for the fiscal year ended September 30, 2009
Item 1. Business
Strategy, page 7
1. In future filings, please describe you r relationship with Hindustan Lifecare
Limited in greater detail. Please publicl y file any agreements between you and
Hindustan Lifecare Limited that are material to your business.
Ms. Donna Felch
The Female Health Company February 25, 2010 Page 2 Government Regulation, page 10
2. In future filings, please expand the discu ssion in the second paragraph to explain
what you mean by, “FC2 received PMA as a Class III Medical Device.” In doing
so, please explain what “PMA” means a nd explain the sign ificance of this
classification.
3. In future filings, please expand the disc ussion in the third paragraph to state
whether the company is in compliance w ith the conditions of the FDA’s approval
order relating to the company’s sales and distribution of the FC2 products.
Item 7. Management’s Discussion and Analys is of Financial Condition and Results of
Operations, page 18
Liquidity and Sources of Capital, page 24
4. We note your statement on page 25 that you believe your “current cash position is
adequate to fund operations . . . in the n ear future.” In future filings, please
expand your liquidity discussion to addr ess liquidity on both a long-term and
short-term basis. To the extent you can do so, when providing guidance about
your liquidity please use more precise pe riods (e.g., the next 12 months) rather
than terms like “in the near future,” whose meaning is less clear. Please refer to
Item 303(a)(1) of Regulation S- K and Instruction 5 thereto.
5. We note that you have two revolving notes with Heartland Bank. Please revise
future filings to discuss the terms and conditions of any si gnificant covenants you
are subject to under these notes. In a ddition, if you are subject to financial
covenants, please revise future annual a nd quarterly filings to present, for the
most significant and restrictive covenants, actual ratios and other actual amounts
versus the minimum/maximum ratios/amounts required at each reporting date. Such a presentation may allow investor s to more easily assess and understand
your current status and future ability to meet your covenants. See Sections I.D
and IV.C of the SEC Inte rpretive Release No. 33-8350
Note 1. Nature of Business and Signif icant Accounting Policies, page F-7
Accounts receivable and concentra tion of credit risk, page F-7
6. Please revise future filings to disclose the percentages of sales to significant
customers for each period presented. Re ference Item 101 of Regulation S-K and
ASC 280-10-50-42.
Ms. Donna Felch
The Female Health Company February 25, 2010 Page 3 Note 6 - Income Taxes, page F-14
7. With a view toward future disclosure, please provide us a more specific and
comprehensive explanation of how you de termined changes in your tax valuation
allowance during each period presented. Se parately address your ability to utilize
U.S. and foreign carry-forwards.
Note 13 - Restructuri ng Costs, page F-23
8. With a view toward future disclosure , please provide us a more specific and
comprehensive discussion of the nature of your restructuring costs. In this regard,
please clarify your “redundancy” and “o ther expenses”. Reference ASC 420-10-
50. Also, please explain to us how you dete rmined the appropriate time period to
accrue the restructuring costs that you recorded in FY 2009 and FY 2010.
Item 15. Exhibits and Financia l Statement Schedules, page 43
9. We note from your disclosure in the Management’s Discussion and Analysis
section that your Heartland Bank credit faci lity represents a potentially important
external source of liquidity for you. Pleas e tell us why you have not filed this
credit facility as an exhibit to your annua l report on Form 10-K. Please note that
if this credit facility is a material co ntract for purposes of Item 601(b)(10) of
Regulation S-K, you should file the credit facility, incl uding all of its schedules
and exhibits, with your next periodic re port or, if you wish, a current report on
Form 8-K.
Exhibit 31.1 and Exhibit 31.2
10. We note that you have deleted the language “(the registrant’s f ourth fiscal quarter
in the case of an annual report)” in each of the two certificatio ns required by Rule
13a-14(a) under the Securities Exchange Act of 1934, as amended. In future
filings, please use the exact form of the certification specified in Item 601(b)(31)
of Regulation S-K. Please refrain from deleting the aforementioned language or
making other un-permitted changes to the fo rm of the certification. Generally, the
only text within the form of the certificati on that may be changed is text that is
contained within brackets in the form.
Form 10-Q for the quarterly period ended December 31, 2009
Note 1 - Basis of Presentation, Foreign Cu rrency and Change in Functional Currency,
page 8
11. We note that you have adopted the U.S. do llar as your functiona l currency for all
of your subsidiaries. Please provide us a specific and comprehensive discussion
Ms. Donna Felch
The Female Health Company February 25, 2010 Page 4
regarding the changed facts and circ umstances, including how you considered
each salient economic factor, in determin ing the U.S. dollar is the appropriate
functional currency. Reference ASC 830-10-55-3.
Note 10 - FC1/FC2 Transition - Restructuring Costs, page 15
12. With a view toward future disclosure , please provide us a more specific and
comprehensive explanation of how you determined the amount of the excess capacity costs and the amount of the dilapi dation and related expenses disclosed
on page 17.
MD&A, Results of Operations, page 29
13. Please revise future annual and quarterly filings to quantify the impact of factors
such as volume, pricing and raw material costs on your results, where practicable.
For example, please disclose and discuss changes in volumes sold, average selling
prices per unit and average cost of sales per unit for each period presented.
* * * *
Please respond to these comments with in 10 business days, or tell us when you
will provide us with a response. Please pr ovide us with a supplemental response letter
that keys your responses to our comment s and provides any requested supplemental
information. Detailed letters greatly facilitate our review. Please file your supplemental
response on EDGAR as a correspondence file . Please understand that we may have
additional comments after reviewin g your responses to our comments.
We urge all persons who are responsible for the accuracy and adequacy of the
disclosure in the filings reviewed by the sta ff to be certain that they have provided all
information investors require. Since the co mpany and its management are in possession
of all facts relating to a company’s disclosure , they are responsible for the accuracy and
adequacy of the disclosures they have made. In connection with responding to our comments, please provide, in writing, a
statement from the company acknowledging that:
• the company is responsible for the adequacy and accuracy of the disclosure in their
filings;
• staff comments or changes to disclosure in response to staff comments do not
foreclose the Commission from taking any action with respect to the filing; and
• the company may not assert staff comments as a defense in any proceeding initiated
by the Commission or any person under the federal securities laws of the United States.
Ms. Donna Felch
The Female Health Company February 25, 2010 Page 5
In addition, please be advise d that the Division of Enfo rcement has access to all
information you provide to the staff of the Divi sion of Corporation Fi nance in our review
of your filing or in response to our comments on your filing.
If you have any questions regarding co mments on the financial statements and
related matters please direct them to Tric ia Armelin, Staff Account ant, at (202) 551-3747,
or, in her absence, to the undersigned at (202) 551-3689. Please contact Dorine Miller,
Financial Analyst, at (202) 551-3711or, in he r absence, Dieter Ki ng, Staff Attorney, at
(202) 551-3338 with any other questions.
S i n c e r e l y , John Hartz
Senior Assistant Chief Accountant
2008-06-13 - UPLOAD - VERU INC.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549-0303
DIVISION OF
CORPORATION FINANCE
April 16, 2007
Via Facsimile at (646) 390-6784 and U.S. Mail
Mr. David Sandberg
Red Oak Capital Partners, LLC
145 Fourth Avenue, Suite 15A
New York, New York 10003
Re: The Female Health Company
Schedule TO-T
Filed by Red Oak Partners, LLC
Filed March 30, 2007
File No. 005-80992
Dear Mr. Sandberg:
We have the following comments on the a bove referenced filing. Please understand
that the purpose of our review process is to assist you in your compliance with the
applicable disclosure requirements and to enha nce the overall disclosure in your filings. We
look forward to working with you in these respects. We welcome any questions you may have about our comments or on any other aspect of our review. Feel free to call us at the
telephone number listed at the end of this letter.
Schedule TO
1. The cover page identifies Red Oak Partners LLC as the offeror. However, the
signature page identifies Red Oak Fund LP as the offeror. Please clarify which
entity is the offeror. Further, to the extent you believe that Red Oak Fund LP is
the offeror, please advise as to what consideration you gave to identifying Red
Oak Capital Partners LLC as a co-offero r in connection with the transaction.
2. We note your statement that Item 10 of Sc hedule TO is “not applicable” to the
offer. Please advise us as to why you believe that the offeror’s financial
statements are not material. See Sect ion II.G.2.a. of SEC Release No. 33-7760
(October 22, 1999). Alternatively, provide the information required by Item 1010(a)-(c) of Regulation M-A, as applicable.
Mr. David Sandberg
Red Oak Capital Partners, LLC
Page 2
Offer to Purchase
Terms of the Offer; Proration; Expiration Date, page 7
3. We note your disclosure that you may not be able to take up and pay for the
shares until five Nasdaq trading days following the expiration of the offer. Please explain why this complies with the prompt payment requirements of Rule 14e-1(c).
4. We note your disclosure that your Depos itary may retain shares tendered and
delay acceptance for payment, subject to th e provisions of Rule 14e-1(c). These
appear to be contradictory disclosures, since the rule requires that you promptly
pay for or return the tendered securities. Please revise.
Acceptance for Payment and Payment, page 9
5. We note that you expect to return un purchased shares “as promptly as
practicable,” rather than “promptly” as Rule 14e-1(c) requires. Please revise.
Withdrawal Rights, page 14
6. Please revise your statement that tenders of shares are irrevocable except as described in Section 4 to in clude the information that any shares that have not
been paid for or returned sixty days after the commencement of the offer may be
withdrawn pursuant to Section 14(d)(5) of the Exchange Act.
Background of the Offer, page 18
7. Please revise this section to include information about the reasons for entering into the Standstill Agreement.
Conditions to the Offer, page 20
8. We believe that a tender offer may be conditioned on a variety of events and
circumstances, provided that they are not w ithin the direct or indirect control of
the bidder, and are drafted with sufficient specificity to allow for objective
verification that the conditions have been satisfied. In this regard, please revise
the language in the parenthetical in subpara graph (a) to provide shareholders with
more specificity about events tri ggering the condition. The language “any
change (or condition, event or development involving a prospective change)” is
too vague to offer much guidance.
Mr. David Sandberg
Red Oak Capital Partners, LLC
Page 3
Closing Comment
We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing review ed by the staff to be certain that they have provided all
information investors require for an informed decision. Since the filing persons are in possession of all facts relating to a company’ s disclosure, they are responsible for the
accuracy and adequacy of the disclosures they have made.
In connection with responding to our comments, please provide, in writing, a statement from each filing person acknowledging that:
that filing person is responsible for the adequacy and accuracy of the disclosure in the filing;
staff comments or changes to disclosure in response to staff comments do not
foreclose the Commission from taking a ny action with respect to the filing;
and
that filing person may not assert st aff comments as a defense in any
proceeding initiated by the Commissi on or any person under the federal
securities laws of the United States.
In addition, please be advise d that the Division of Enfo rcement has access to all
information you provide to the staff of the Divisi on of Corporation Fina nce in our review of
your filing or in response to our comments on your filing.
As appropriate, please amend your filings in response to these comments. You may
wish to provide us with black-lined copies of the amended filings to expedite our review.
Please furnish a cover letter w ith your amended filing that keys your responses to our
comments and provides any requested supplementa l information and file such letter on
EDGAR. Detailed cover letters greatly facilitate our review. Please understand that we may
have additional comments after reviewing your amended filings and responses to our
comments.
If you have any questions please contact me at (202) 551-3267 or by facsimile at
(202) 772-9203.
Very truly yours,
Julia E. Griffith
Special Counsel
Office of Mergers and Acquisitions
Mr. David Sandberg
Red Oak Capital Partners, LLC
Page 4
2008-03-13 - UPLOAD - VERU INC.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549-7010
DIVISION OF
CORPORATION FINANCE
Mail Stop 7010
March 13, 2008
Ms. Donna Felch The Female Health Company 515 North State Street, Suite 2225 Chicago, Illinois 60610
RE: The Female Health Company
Form 10-KSB for the fiscal year ended September 30, 2007
Filed December 21, 2007
File # 1-13602
Dear Ms. Felch:
We have completed our review of your Fo rm 10-K and related filings and have no
further comments at this time.
If you have any further questions regard ing our review of your filings, please
direct them to Tricia Armeli n, Staff Accountant, at (202) 551 -3747 or, in her absence, to
the undersigned at (202) 551-3768.
Sincerely,
John Cash A c c o u n t i n g B r a n c h C h i e f
2008-02-28 - CORRESP - VERU INC.
CORRESP
1
filename1.htm
fhcfeb282008responsetosec.htm
February 28,
2008
SENT
VIA
EDGAR
Mr.
John
Cash
Accounting
Branch Chief
United
States Securities and Exchange Commission
Division
of Corporation Finance
Washington,
D.C. 20549
Re:
The
Female Health Company Form 10-KSB
for the year ended September 30, 2007
File
No. 1-13602
Dear
Mr.
Cash:
The
following are the responses of The Female Health Company (the "Company") to
the
comments in the letter of the staff of the Securities and Exchange Commission
dated February 20, 2008 relating to the Company's Form 10-KSB for the year
ended September 30, 2007. For reference purposes, the text of
the staff's comment letter has been reproduced below with responses below for
each numbered paragraph.
Form
10-KSB for the Year
Ended September 30, 2007
Item
6. MD&A – Liquidity
and Sources of Capital, page 20
Comment
1:
We
have reviewed your response to our prior comment three. The enhanced
disclosure you have included in your Form 10-Q for the period ended December
31,
2007 is not sufficiently detailed enough to enable a reader to understand the
nature of an changes in your accounts receivable balance. Please
revise future filings to include more specific and comprehensive
disclosures.
Response
to Comment No.
1:
The
Company will expand the disclosure of its accounts receivable balance in
MD&A in future filings. Below is a proposed form of such
disclosure.
The
Company's quarter-end accounts receivable balance is impacted by various factors
besides rising sales levels. A primary factor is the Company's
pattern of production and sales, which causes accounts receivable to spike
near
quarter end. The Company's U.K subsidiary produces product early in
the quarter to be sold by its U.S. parent, thus ensuring that most sales to
third parties occur in the second half of the quarter. The timing of
large orders can have a significant impact on the quarter-end
balance. The Company's standard credit terms vary from 30 to 90days,
depending on the class of trade and customary terms within a territory, so
accounts receivable is affected by the mix of purchasers within the
quarter. As is typical in the Company's business, the Company may
offer extended credit terms as a sales promotion. For the past twelve
months, the Company's average days sales outstanding has been approximately
60
days.
Note
1. Nature of Business
and Significant Accounting Policies, page F-7
Deferred
Grant Income, page
F-9
Comment
No. 2:
We
have reviewed your response to our prior comment four. Please revise
future filings to disclose the full impact that the government grants have
had
on your financial statements in a given period, including proceeds that are
credited to income for expenses and proceeds that are released to income in
connection with depreciation expense.
Response
to Comment No.
2:
In
future
filings, the Company will disclose the full impact of government grants on
the
Company's financial statements in all applicable periods, including the amount
of grant proceeds credited to income and the amount of grant proceeds released
to income in connection with depreciation of the relevant assets.
Please
contact me at (312) 595-9742 if you have any questions on any of the responses
to your comments.
Best
regards,
The
Female Health Company
/s/
Donna
Felch
Donna
Felch
Vice
President and Chief Financial Officer
2008-02-20 - UPLOAD - VERU INC.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549-7010
DIVISION OF
CORPORATION FINANCE
Mail Stop 7010
February 20, 2008
Ms. Donna Felch
The Female Health Company 515 North State Street, Suite 2225 Chicago, Illinois 60610
RE: The Female Health Company
Form 10-KSB for the fiscal year ended September 30, 2007
Filed December 21, 2007
File # 1-13602
Dear Ms. Felch:
We have reviewed your response letter dated February 11, 2008 and have the
following additional comments. If you disagree , we will consider your explanation as to
why our comment is inapplicable. In some of our comments, we may ask you to provide
us with supplemental information so we ma y better understand your disclosure. After
reviewing this information, we may or may not raise additional comments.
Form 10-KSB for the fiscal year ended September 20, 2007
Item 6. MD&A - Liquidity and Sources of Capital, page 20
1. We have reviewed your response to our prior comment three. The enhanced
disclosure you have included in your Fo rm 10-Q for the period ended December
31, 2007 is not sufficiently detailed enough to enable a reader to understand the
nature of and changes in your accounts rece ivable balance. Please revise future
filings to include more specific and comprehensive disclosures.
Note 1. Nature of Business and Signif icant Accounting Policies, page F-7
Deferred Grant Income, page F-9
2. We have reviewed your response to our pr ior comment four. Please revise future
filings to disclose the full impact th at the government grants have had on your
financial statements in a given period, including proceeds that are credited to
Ms. Donna Felch
The Female Health Company February 20, 2008 Page 2
income for expenses and proceeds that are released to income in connection with
depreciation expense.
* * * *
As appropriate, please respond to these co mments within 10 business days or tell
us when you will provide us with a response. Please furnish a letter that keys your
responses to our comments and provides any requested supplemental information.
Detailed response letters greatly facilitate our review. Please file your response letter on
EDGAR. Please understand that we may have additional comments after reviewing your
responses to our comments.
If you have any questions regarding these co mments, please direct them to Tricia
Armelin, Staff Accountant, at (202) 551-3747, Anne McConnell, Senior Accountant, at
(202) 551-3709 or, in their absence, to the undersigned at (202) 551-3768.
S i n c e r e l y ,
John Cash A c c o u n t i n g B r a n c h C h i e f
2008-02-11 - CORRESP - VERU INC.
CORRESP
1
filename1.htm
fhcfeb112008responsetosec.htm
February
11, 2008
SENT
VIA
EDGAR
Mr.
John
Cash
Accounting
Branch Chief
United
States Securities and Exchange Commission
Division
of Corporation Finance
Washington,
D.C. 20549
Re:
The
Female Health Company Form 10-KSB
for the year ended September 30, 2007
File
No. 1-13602
Dear
Mr.
Cash:
The
following are the responses of The Female Health Company (the "Company") to
the
comments in the letter of the staff of the Securities and Exchange Commission
dated January 30, 2008 relating to the Company's Form 10-KSB for the year
ended September 30, 2007. For reference purposes, the text of
the staff's comment letter has been reproduced below with responses below for
each numbered paragraph.
Form
10-KSB for the Year
Ended September 30, 2007
General
Comment
No.
1
It
appears that your public float may have exceeded $25 million in the years ended
September 30, 2007, 2006 and 2005. Please clarify for us how you determined
that you qualify as a small business issuer. Reference Item 10
of Regulation S-B.
Response
to Comment No.
1
With
respect to the public float limit, Item 10(a)(2)(iii) of
Regulation S-B provides that once a small business issuer becomes a
reporting company it will remain a small business issuer until it exceeds the
public float limit at the end of two consecutive years. The public
float limit is tested by use of a price at which the Company's stock was last
sold, or the average of the bid and asked prices of such stock, on a date within
60 days prior to the end of the Company's fiscal year end.
As
of
September 30, 2006, there were 24,208,391 shares of the Company's $0.01 par
value common stock (the "Common Stock") outstanding, the only class of common
equity of the Company. Directors and executive officers of the
Company (who are all affiliates of the Company) collectively held 7,602,788
shares of Common Stock as of September 30, 2006. As a result, the
number of shares of Common Stock held by non-affiliates was
16,605,603. On September 25, 2006, a date within 60 days of the
Company's fiscal year end of September 30, 2006, the Common Stock closed at
$1.20 per share on the OTC Bulletin Board. At that price, the
Company's public float was $19,926,724 (16,605,603 shares x $1.20 =
$19,926,724). Because that number is less than $25 million, the
Company was under the public float limit for its fiscal year ended
September 30, 2006, and because ending small business issuer status
requires that an issuer exceed the public float limit for two consecutive years,
the Company was also a small business issuer for its fiscal years ended
September 30, 2007 and September 30, 2005.
Item
1. Description of
Business, page 5
Product,
page
5
Comment
No.
2.
Please
revise future filings to disclose and discuss the process and expected timing
for FDA approval of FC2.
Response
to Comment No.
2:
The
disclosure in the Company’s Form 10-QSB for the quarter ended
December 31, 2007 will be expanded to read as follows:
The
FC2
pre-market approval application (PMA) submitted by the Company on January 8,
2008, was accepted for FDA review on January 28, 2008. That
acceptance marks the beginning of the FDA review process, which generally can
take up to 180 active review days. During this process, the FDA may
ask questions regarding the submission. The time spent on answering
such questions is not counted as review process time. Following the
FDA review, the submission’s merits will be reviewed and discussed by FDA’s
OB-GYN Device Advisory Panel. The final step to approval is
negotiation and approval of the product’s labeling. The entire
process may typically take up to 360 days.
Item
6. MD&A – Liquidity
and Sources of Capital, page 20
Comment
3
With
a view towards future disclosure, please explain to us why your accounts
receivable balance significantly increased and help us understand why days
outstanding are so significant in light of the fact that your disclosed payments
terms are a net 30 day basis.
2
Response
to Comment No.
3:
Historically,
the Company’s “standard” credit terms to its largest customer class has been 30
days net. However, as the Company business with distribution partners
expanded, it was necessary to offer competitive credit terms typical for that
customer class. Such terms vary from 60 to 90 days net, depending on
what is customary in the country where the distributor does
business. Also, as is typical in the Company's business, the Company
occasionally offers extended credit terms as a sales promotion. The
increased sales to distributors and the occasional credit extension have
increased days outstanding for sales in recent periods. An analysis
of the past five quarters reveals that days’ sales outstanding average is about
60 days.
To
understand the accounts receivable balance at year end, it is necessary to
know
the Company’s production and sales pattern. A typical quarter falls
like this: In the first half of each quarter, the Company's UK
subsidiary produces goods to be sold by its North American parent. As
a result, a significant portion of the sales in the first half of the quarter
are inter-company transactions which have no impact on accounts receivable
as it
eliminates in consolidation. These inter-company sales arrive in the
US from about mid-quarter and onward. So the US parent’s sales occur
primarily in the second half of the quarter, a function of when its inventory
arrives. Production of inter-company sales in months one and two also reduces
the UK subsidiary’s third party sales in the first half of the
quarter. Thus, the Company’s pattern of production and sales tends to
cause accounts receivable to spike near the quarter end.
At
September 30, 2007, the accounts receivable balance of $6.1 million
represented approximately 74 days’ sales outstanding. This was due to
both the Company’s typical production and sales pattern and the inclusion of a
$1 million invoice with extended terms (120 days).
In
future
filings, the Company will expand the credit terms disclosure to describe the
Company's terms and reflect the current average days’ sales
outstanding.
Note
1. Nature of Business
and Significant Accounting Policies, page F-7
Deferred
Grant Income, page
F-9
Comment
No.
4:
Please
provide us a more comprehensive discussion of the nature of the project for
which you received grant money from the British Linkage Challenge
Fund. In this regard, please also more fully describe how you
determined that the contributions should be recognized as income.
3
Response
to Comment No.
4:
The
Company receives grant monies from the British Linkage Challenge Fund (the
"BLCF"). This fund was set up by the UK Department for International
Development and is a cost and risk sharing grant scheme to develop partnerships
between businesses nationally and internationally and to carry out innovative
pilot projects. The grants are provided on the basis of a 1:1 funding by the
BLCF and the companies involved. The BLCF's goal is to improve access to
sustainable livelihood opportunities for poor people by improving the
competitiveness and ability of business to access markets. This is done through
linkages that exchange technology, skill, information and market access. The
BLCF's expected outcomes are productive inter-firm linkages among firms of
all
sizes and all activity, involved in export or domestic markets, services as
well
as processed goods.
The
project for which the Company receives this grant relates to the development
of
a linkage with Hindustan Latex Limited, in India, to manufacture the
female condom in India and develop the market for the product in that
country.
The
grant
received is split between the Company and Hindustan Latex Limited pro-rata
to
their respective expenditure on the project.
The
Company recognized that there are no U.S. accounting pronouncements that
specifically address how to account for government grants. The
Company utilized the general precepts of U.S. GAAP and the principles of
matching and conservatism to determine how to account for the grant monies
received. The Company also utilized the guidance of International
Accounting Standard No. 20 – Accounting for Government Grants and Disclosure of
Government Assistance to further support the Company's accounting treatment
of
the grant received. The Company allocates its share of the grant
monies to capital and expense pro-rata to the respective cost allocated to
the
project. Grant proceeds for expenses are credited to income in the quarter
incurred. Grant proceeds for capital expenditure are deferred and released
to income in line with the depreciation of the relevant assets.
Note
6. Income Taxes, page
F-12
Comment
No.
5
Please
revise future filings to disclose and discuss how you determined the amount
of
tax valuation allowance that you released and how you will assess the remaining
allowance in future periods.
Response
to Comment No.
5:
We
account for income taxes using the liability method, which requires the
recognition of deferred tax assets or liabilities for the tax-affected temporary
differences between the financial reporting and tax bases of our assets and
liabilities, and for net operating loss and tax credit
carryforwards.
4
During
fiscal year 2007, we recorded an income tax benefit of $825,000. This benefit
consisted of an $825,000 reduction in the valuation allowance related to a
portion of our deferred tax assets that will more likely than not be realized,
based on future projected taxable income. In evaluating our ability to realize
our deferred tax assets we consider all available positive and negative evidence
including our past operating results and our forecast of future taxable income.
In determining future taxable income, we make assumptions to forecast U.S.
federal, U.S. state, and international operating income, the reversal of
temporary differences, and the implementation of any feasible and prudent tax
planning strategies. These assumptions require significant judgment regarding
the forecasts of future taxable income, and are consistent with the forecasts
used to manage our business. We intend to maintain the remaining valuation
allowance until sufficient further positive evidence exists to support further
reversals of the valuation allowance. Our income tax expense recorded in the
future will be reduced to the extent of offsetting decreases in our valuation
allowance. We will expand the discussion of the determination of our
tax valuation allowance in future filings.
The
Company acknowledges that (i) it is responsible for the adequacy and accuracy
of
the disclosure in its filings; (ii) staff comments or changes to disclosure
in
response to staff comments do not foreclose the Commission from taking any
action with respect to the filing; and (iii) it may not assert staff comments
as
a defense in any proceeding initiated by the Commission or any person under
the
federal securities laws of the United States.
Please
contact me at (312) 595-9742 if you have any questions on any of the responses
to your comments.
Best
regards,
The
Female Health Company
/s/
Donna
Felch
Donna
Felch
Vice
President and Chief Financial Officer
5
2008-01-30 - UPLOAD - VERU INC.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549-7010
DIVISION OF
CORPORATION FINANCE
Mail Stop 7010
January 30, 2008
Ms. Donna Felch The Female Health Company 515 North State Street, Suite 2225 Chicago, Illinois 60610
RE: The Female Health Company
Form 10-KSB for the fiscal year ended September 30, 2007
Filed December 21, 2007
File # 1-13602
Dear Ms. Felch:
We have reviewed your filings and have the following comments. Where
indicated, we think you should re vise your document in response to these comments. If
you disagree, we will consider your explanation as to why our comment is inapplicable or
a revision is unnecessary. Please be as deta iled as necessary in your explanation. In
some of our comments, we may ask you to pr ovide us with supplemental information so
we may better understand your disclosure. Af ter reviewing this information, we may or
may not raise additional comments.
Please understand that the purpose of our re view process is to assist you in your
compliance with the applicable disclosure requirements and to enhance the overall
disclosure in your filing. We look forward to working with you in these respects. We
welcome any questions you may have about our comments or on any other aspect of our
review. Feel free to call us at the telephone numbers listed at the end of this letter.
Form 10-KSB for the fiscal year ended September 20, 2007
General
1. It appears that your public float may have exceeded $25 million in the years
ended September 30, 2007, 2006 and 2005. Please clarify for us how you determined that you qualify as a small business issuer. Re ference Item 10 of
Regulation S-B.
Ms. Donna Felch
The Female Health Company January 30, 2008 Page 2
Item 1. Description of Business, page 5
Product, page 5
2. Please revise future filings to disclose and discuss the process and expected
timing for FDA approval of FC2.
Item 6. MD&A - Liquidity and Sources of Capital, page 20
3. With a view towards future disclosure , please explain to us why your accounts
receivable balance significantly increa sed and help us understand why days
outstanding are so significant in light of the fact that your disclosed payment
terms are a net 30 day basis.
Note 1. Nature of Business and Signif icant Accounting Policies, page F-7
Deferred Grant Income, page F-9
4. Please provide us a more comprehensive di scussion of the nature of the project
for which you received grant money from the British Linkage Challenge Fund. In this regard, please also more fully descri be the accounting for this arrangement,
including how you determined that the c ontributions should be recognized as
income.
Note 6. Income Taxes, page F-12
5. Please revise future filings to disclose and discuss how you determined the
amount of the tax valuation allowance that you released and how you will assess
the remaining allowance in future periods.
* * * *
Please respond to these comments with in 10 business days, or tell us when you
will provide us with a response. Please pr ovide us with a supplemental response letter
that keys your responses to our comment s and provides any requested supplemental
information. Detailed letters greatly facilitate our review. Please file your supplemental
response on EDGAR as a correspondence file . Please understand that we may have
additional comments after reviewin g your responses to our comments.
We urge all persons who are responsible for the accuracy and adequacy of the
disclosure in the filings reviewed by the sta ff to be certain that they have provided all
information investors require. Since the co mpany and its management are in possession
of all facts relating to a company’s disclosure , they are responsible for the accuracy and
adequacy of the disclosures they have made.
Ms. Donna Felch
The Female Health Company January 30, 2008 Page 3 In connection with responding to our comments, please provide, in writing, a
statement from the company acknowledging that:
• the company is responsible for the adequacy and accuracy of the disclosure in their
filings;
• staff comments or changes to disclosure in response to staff comments do not
foreclose the Commission from taking any action with respect to the filing; and
• the company may not assert staff comments as a defense in any proceeding initiated
by the Commission or any person under the federal securities laws of the United States.
In addition, please be advise d that the Division of Enfo rcement has access to all
information you provide to the staff of the Divi sion of Corporation Fi nance in our review
of your filing or in response to our comments on your filing.
If you have any questions regarding these co mments, please direct them to Tricia
Armelin, Staff Accountant, at (202) 551-3747, Anne McConnell, Senior Accountant, at
(202) 551-3709 or, in their absence, to the undersigned at (202) 551-3768.
S i n c e r e l y ,
John Cash A c c o u n t i n g B r a n c h C h i e f
2005-09-16 - UPLOAD - VERU INC.
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
Mail Stop 07010
September 16, 2005
Mr. Robert R. Zic
The Female Health Company
515 North State Street, Suite 2225
Chicago, IL 60610
RE: The Female Health Company
Form 10-KSB for the year ended September 30, 2004
Filed December 29, 2004
File No. 1-13602
Dear Mr. Zic:
We have completed our review of your Form 10-K and related
filings and have no further comments at this time.
If you have any further questions regarding our review of
your
filings, please direct them to Patricia Armelin, Staff Accountant,
at
(202) 551-3747 or, in her absence, to the undersigned at (202)
551-
3768.
Sincerely,
John Cash
Accounting Branch Chief
??
??
??
??
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549-7010
DIVISION OF
CORPORATION FINANCE
</TEXT>
</DOCUMENT>
2005-07-07 - CORRESP - VERU INC.
CORRESP
1
filename1.htm
FHC July 2005 Correspondence re 2004 Form 10-KSB
July
7,
2005
SENT
VIA
EDGAR
Mr.
John
Cash
Accounting
Branch Chief
United
States Securities and Exchange Commission
Division
of Corporation of Finance
Washington,
D.C. 20549
Re:
The Female Health Company Form 10-KSB for the year ended September 30,
2004
File No. 1-13602
Dear
Mr.
Cash:
The
following is the response of the Female Health Company (the “Company”) to the
comment in the letter of the staff of the Securities and Exchange Commission
dated June 23, 2005 relating to the Company’s Form 10-KSB for the year ended
September 30, 2004. For reference purposes, the text of the staff’s comment
letter has been reproduced below together with the Company's response to the
comment.
Form
10-KSB for the Year Ended September 30, 2004
Note
1. Nature of Business and Significant Accounting Policies - Earnings
per
Share
Comment
No. 1
We
note
your response to our prior comment three and your revised disclosure in the
Form
10-Q for the period ended March 31, 2005. However, in situations in which the
computation of diluted EPS would have an anti-dilutive effect on earnings per
share, the diluted weighted average common shares outstanding on the face of
the
income statement should be the same number as the basic weighted average shares
outstanding. Further, the number of incremental shares issuable upon conversion
of your convertible preferred stock or convertible debt and the exercise of
stock options and warrants that were not included in the diluted earnings per
share because their effect would be anti-dilutive should be disclosed in a
footnote to the financial statements. Reference paragraphs 38 and 40c of SFAS
128. Please revise as appropriate.
Response
to Comment No. 1
As
a
result of the Company’s computation of diluted EPS having an anti-dilutive
effect on earnings per share, the diluted weighted average common shares
outstanding on the face of the income statement has the same number as the
basic
weighted average common shares outstanding in the Company's Form 10-KSB for
the
year ended September 30, 2004.
Mr.
John
Cash
Accounting
Branch Chief
July
7,
2005
Page
2
We
note
that our revised disclosure in the Form 10-QSB for the period ended March 31,
2005 was not consistent with your previous comment three. We
will
prepare future filings in a manner that is consistent with your comment.
Therefore, beginning with the Company’s Form 10-QSB for the quarterly period
ended June 30, 2005, the Company will disclose the number of incremental shares
issuable upon conversion of the Company’s convertible preferred stock,
convertible debt and the exercise of stock options and warrants that are not
included in diluted earnings per share because their effect would be
anti-dilutive, in a footnote to the financial statements in accordance with
paragraphs 38 and 40c of SFAS 128.
Please
contact me at (916) 773-1573 if you have any further questions on any responses
to your comments.
Best
regards,
The
Female Health Company
/s/
Robert R. Zic
Robert
R.
Zic
Principal
Accounting Officer
2005-06-23 - UPLOAD - VERU INC.
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
Mail Stop 0710
June 23, 2005
Mr. Robert R. Zic
The Female Health Company
515 North State Street, Suite 2225
Chicago, IL 60610
RE: The Female Health Company
Form 10-KSB for the year ended September 30, 2004
Filed December 29, 2004
File No. 1-13602
Dear Mr. Zic:
We have reviewed your response letter dated May 24, 2005 and
have the following additional comments. If you disagree, we will
consider your explanation as to why our comment is inapplicable.
In
some of our comments, we may ask you to provide us with
supplemental
information so we may better understand your disclosure. After
reviewing this information, we may or may not raise additional
comments.
Form 10-KSB for the Year Ended September 30, 2004
Note 1. Nature of Business and Significant Accounting Policies -
Earnings per Share
1. We note your response to our prior comment three and your
revised
disclosure in the Form 10-Q for the period ended March 31, 2005.
However, in situations in which the computation of diluted EPS
would
have an antidilutive effect on earnings per share, the diluted
weighted average common shares outstanding on the face of the
income
statement should be the same number as the basic weighted average
common shares outstanding. Further, the number of incremental
shares
issuable upon conversion of your convertible preferred stock or
convertible debt and the exercise of stock options and warrants
that
were not included in the diluted earnings per share because their
effect would be anti-dilutive should be disclosed in a footnote to
the
financial statements. Reference paragraphs 38 and 40c of SFAS
128.
Please revise as appropriate.
* * * *
As appropriate, please respond to these comments within 10
business days or tell us when you will provide us with a response.
Please furnish a letter that keys your responses to our comments
and
provides any requested supplemental information. Detailed
response
letters greatly facilitate our review. Please file your response
letter on EDGAR. Please understand that we may have additional
comments after reviewing your responses to our comments.
If you have any questions regarding these comments, please
direct them to Patricia Armelin, Staff Accountant, at (202) 551-
3747,
Jeanne Baker, Assistant Chief Accountant, at (202) 551-3691 or, in
their absence, to the undersigned at (202) 551-3768.
.
Sincerely,
John Cash
Accounting Branch Chief
??
??
??
??
Mr. Robert R. Zic
The Female Health Company
June 23, 2005
Page 1
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549-0710
DIVISION OF
CORPORATION FINANCE
</TEXT>
</DOCUMENT>
2005-05-24 - CORRESP - VERU INC.
CORRESP
1
filename1.htm
FHC May 2005 Correspondence
May 24,
2005
SENT VIA
EDGAR
Mr. John
Cash
Accounting
Branch Chief
United
States Securities and Exchange Commission
Division
of Corporation Finance
Washington,
D.C. 20549
Re:
The
Female Health Company Form 10-KSB for the year ended September 30,
2004
File No. 1-13602
Dear Mr.
Cash:
The
following are the responses of The Female Health Company (the "Company") to the
comments in the letter of the staff of the Securities and Exchange Commission
dated May 10, 2005 relating to the Company's Form 10-KSB for the year ended
September 30, 2005. For reference purposes, the text of the staff's comment
letter has been reproduced below with responses below for each numbered
paragraph.
Form
10-KSB for the Year Ended September 30, 2004
Note 1
- Nature of Business and Significant Accounting Policies - Revenue
Recognition
Comment
No. 1
As
indicated in your accounts receivable policy, we note that you offer a right of
product returns from customers in connection with unsold product which has
expired or is expected to expire before it is sold. Address for us
supplementally how you have determined that you can reasonably estimate the
amount of future returns as required by paragraph 6f of SFAS 48. In this regard,
address the factors set forth in paragraph 8 of SFAS 48 and address whether
those factors impair your ability to make a reasonable estimate of returns. In
particular, please tell us how you estimate the returns of new customers which
you have no previous relationship. Also tell us what the estimated life of your
product is and how you determine whether items may be returned due to
expiration. Clarify in your revenue recognition policy that revenue is recorded
net of such estimated returns.
Response
to Comment No. 1
The
Company’s policy related to product returns from customers in connection with
unsold product which has expired or is expected to expire before it is sold was
established to cover specific retail industry condom sales.
Mr. John
Cash
Accounting
Branch Chief
May 24,
2005
Page
2
Factors
stated in paragraph 8 of SFAS 48 such as susceptibility of the product to
significant external factors, absence of historical experience, changes in the
selling enterprise’s marketing policies or relationships with its customers, or
absence of a large volume of relatively homogenous transactions do not apply
and, therefore, the Company concluded that it has the ability to make a
reasonable estimate of future returns.
In 1997,
the Center for Devices and Radiological Health of the Food and Drug
Administration approved the estimated life of the Company's product to be five
years. The Company labels each product sold with the month and date the product
was manufactured and its expiration date, which is exactly five years subsequent
to the manufactured date.
The
Company’s estimate of current year sales returns is based on a 3 year rolling
average of actual returns as a percentage of sales. The Company utilized the
estimate for all related business regardless of whether it was transacted with
an existing customer or a new customer with whom it had no previous
relationship.
Historically,
a significant majority (90%+) of the Company’s trade sales were made up of U.S.
trade sales. Beginning in fiscal 2001 the Company entered into a seven year
exclusive arrangement with Mayer Laboratories, Inc. ("Mayer") to be the
exclusive distributor of the Company's U.S. trade sales. As part of this
arrangement Mayer agreed to accept the sole responsibility (after the first 12
months of the agreement) for returns of U.S. trade sales and thereby eliminated
nearly all of the Company’s risk of sales returns for the duration of the
arrangement with Mayer.
Presently,
the Company derives over 95% of its total sales from public sector sales where
the aforementioned sales return policy applies only to damaged goods, not
returns in connection with unsold product which has expired or is expected to
expire before it is sold.
For the
remaining trade business which is of a nominal value, the Company accrues the
estimated sales returns and records the related revenue net of such estimated
returns.
The
Company will expand the discussion of its accounts receivable and credit risk
accounting policy, and will clarify in the discussion of the revenue recognition
policy that revenue is recorded net of estimated returns, in the notes to the
financial statements in future filings.
Mr. John
Cash
Accounting
Branch Chief
May 24,
2005
Page
3
Comment
No. 2
Address
for us supplementally and revise your disclosures as appropriate to address
those instances where you have recognized revenue other than at
shipment.
Response
to Comment No. 2
The
Company recognizes revenue from product sales when products are shipped to
customers, when an arrangement exists, delivery has occurred, there is a fixed
price, and collectibility is reasonably assured. There are no instances that the
Company has recognized revenue other than at shipment. The Company will expand
the discussion of its revenue recognition accounting policy in the notes to the
financial statements in future filings.
Note 1
- Nature of Business and Significant Accounting Policies - Earnings per
Share.
Comment
No. 3
In
future filings disclose the number of incremental common shares issuable upon
conversion of your convertible preferred stock or convertible debt and the
exercise of stock options and warrants that were not included in diluted
earnings per share because their effect would be anti-dilutive. Refer to
paragraph 40c of SFAS 128.
Response
to Comment No. 3
Beginning
with the Form 10-QSB for the quarterly period ended March 31, 2005, filed with
the SEC on May 16, 2005, the Company disclosed diluted earnings per share
and weighted average common shares outstanding within the Company’s unaudited
condensed consolidated statement of operations for the three months and six
months ended March 31, 2005 and 2004.
The
calculations of the diluted earnings per share and weighted average common
shares outstanding includes the number of incremental common shares issuable
upon conversion of the Company’s convertible preferred stock, convertible debt
and the exercise of stock options and warrants in accordance with SFAS
128.
Mr. John
Cash
Accounting
Branch Chief
May 24,
2005
Page
4
Note 1
- Nature of Business and Significant Accounting Policies - Other Comprehensive
Income
Comment
No. 4
Tell
us supplemtentally and revise future filings to address the $249,555 adjustment
to other comprehensive loss. Tell us the nature of the adjustment, the terms and
parties to the intercompany debt and the appropriateness of reflecting this
adjustment in other comprehensive income.
Response
to Comment No. 4
The
Company’s consolidated financial statements include the accounts of The Female
Health Company (Parent Company and U.S. corporation) and the accounts of its
wholly owned foreign subsidiaries, The Female Health Company - UK, which is the
holding company of The Female Health Company, plc. (located in the United
Kingdom).
Over the
years, the Company has financed the operations of its subsidiaries through an
intercompany loan with The Female Health Company, plc. which was eliminated upon
consolidation. The Company has designated the intercompany loan to be long-term
in nature as prescribed by SFAS 52. Further, the Company followed the guidance
of SFAS 52 paragraph 20.b. when translating the subsidiary’s balance sheet for
consolidation purposes. This paragraph states that: "Gains and losses on
intercompany foreign currency transactions that are of a long-term-investment
nature (that is, settlement is not planned or anticipated in the foreseeable
future), should not be included in the computation of net income when the
entities to the transaction are consolidated." In other words, any foreign
currency effects of the long-term intercompany loan were included in accumulated
other comprehensive income on the balance sheet and flowed through other
comprehensive income or loss on the Consolidated Statement of Stockholders’
Equity.
During
the year ended September 30, 2005, the Company forgave a portion of this
loan and needed to adjust accumulated other comprehensive income on the balance
sheet for the cumulative amount of foreign currency adjustments relating to this
portion of the intercompany loan. In essence, there was a portion of trapped
currency translation that needed to be recognized through a reclassification
within equity.
Since the
currency effect of the change in the intercompany debt flowed through
comprehensive income (loss) as income while the debt was outstanding, it appears
appropriate to flow the currency effect of the debt forgiveness through
comprehensive income (loss) as an expense when the debt was forgiven. What this
in effect does is makes the cumulative comprehensive income (loss) related to
this portion of the intercompany loan zero.
The
Company will expand the disclosure of this transaction in future
filings.
Mr. John
Cash
Accounting
Branch Chief
May 24,
2005
Page
5
Note 8
- Common Stock - Stock Options Plans
Comment
No. 5
As
indicated by transactions reflected within your Consolidated Statements of
Stockholders' Equity, we note that you issued stock through the cashless
exercise of stock options and warrants. Please address supplementally and revise
future filings to clarify your accounting for stock and warrants granted with
cashless exercise features. Your response should identify the accounting
literature you relied on and address the guidance in Issue 48 of EITF 00-23:
Issues Related to the Accounting for Stock Compensation under APB Opinion No. 25
and FASB Interpretation No. 44.
Response
to Comment No. 5
During
the year ended September 30, 2002, the Company re-priced the majority of its
outstanding stock options; and accordingly, under APB Opinion No. 25, utilized
variable-plan accounting for these options. Also during this time, the Company
implemented an immaculate cashless exercise feature for these options. Since the
options were already being accounted for under variable-plan guidance, no
additional accounting treatment was deemed necessary.
In
September 2002, the majority the Company’s stock options were exchanged for the
right to receive new options at least six months and a day later. The exercise
prices of these new options were equal to the fair market value of the common
stock on the grant date. These options are being accounted for in accordance
with fixed plan accounting guidance as provided in APB Opinion No. 25. Options
covering a total of 320,000 shares did not participate in the exchange and the
Company continued to account for these options under variable-plan accounting
until exercised. As of September 30, 2004, none of these options were
outstanding.
The
Company has certain warrant agreements that have a cashless exercise feature.
For all of the Company’s warrant agreements, the Company has utilized the
accounting guidance of SFAS 123 since the warrants were issued to non-employees.
The Company computed the fair value of the warrants via the Black-Scholes
pricing model. Therefore, the fair value of the warrants was expensed over their
vesting periods and the fact that a cashless feature existed did not create any
additional accounting ramifications.
The
Company did not apply the accounting guidance discussed in Issue 48 of EITF
00-23: Issues Related to the Accounting for Stock Compensation under APB Opinion
No. 25 and FASB Interpretation No. 44 since the cashless exercise was not
effected through a broker.
The
Company will expand the disclosure in future filings to describe how the Company
accounts for stock options and warrants granted with cashless exercise
features.
Mr. John
Cash
Accounting
Branch Chief
May 24,
2005
Page
6
Item
8A. Controls and Procedures
Comment
No. 6
We
note your statement that the chief executive officer and the principal
accounting officer have concluded that the company's disclosure controls and
procedures are effective "except as discussed below." Given the exceptions
noted, it remains unclear whether your chief executive officer and principal
accounting officer have concluded that your disclosure controls and procedures
are effective. Please revise your disclosure to state, in clear and unqualified
language, the conclusions reached by your chief executive officer and your
principal accounting officer on the effectiveness of your disclosure controls
and procedures. For example, if true, you can state that your disclosure
controls and procedures are effective including consideration of the identified
matters, so long as you provide appropriate disclosure explaining how the
disclosure controls and procedures were determined to be effective in light of
the identified matters. Or, if true, you can state that given the identified
matters, your disclosure controls and procedures are not effective. You should
not, however, state the conclusion in your current disclosure, which appears to
state that your disclosure controls and procedures are effective except to the
extent that they are not effective.
Response
to Comment No. 6
The
Company’s Chief Executive Officer and Principal Accounting Officer concluded
that the Company’s disclosure controls and procedures were effective despite the
two material weaknesses because the material weaknesses involved isolated
matters affecting relatively discreet transactions and account balances which
the Company deemed not to have a material impact on the overall financial
statements. Management believes the issues were promptly brought to its
attention and acted upon. Beginning with the Form 10-QSB for the quarterly
period ended March 31, 2005, filed with the SEC on May 16, 2005, the
Company revised the disclosure in the section addressing controls and procedures
section to reflect this conclusion.
Comment
No. 7
Disclose
in greater detail the nature of the material weaknesses identified in your
disclosure. In this regard, also revise to disclose the specific steps that the
company has taken, if any, to remediate the material
weaknesses.
Mr. John
Cash
Accounting
Branch Chief
May 24,
2005
Page
7
Response
to Comment No. 7
The first
material weakness identified in the disclosure relates to the timeliness of
accounting for certain transactions. Equity transactions pertaining to outside
consultants and new employees were not communicated in a timely manner to the
Principal Accounting Officer by senior management.
During
the quarter following the discovery of each issue the Company discussed setting
up a procedure to eliminate the possibility of future exceptions. No new
weaknesses relating to the specific equity transactions have subsequently
occurred.
The
second weakness relates to the adequacy of supervisory reviews. The lack of
reviews resulted in adjustments being proposed during the year-end field work by
the Company’s external auditors.
To
remediate this weakness, beginning with the first quarter of the current fiscal
year, the Principal Accounting Officer began reviewing all of the components of
the U.K. financial statements. No new adjustments have been proposed by the
Company’s external auditors during the first two quarters of the current fiscal
year related to the U.K. financials. In the U.S., the Company has begun the
process of hiring a consultant to function as an accounting manager and allow
the Principal Accounting Officer to serve in a supervisory review function. The
Company believes the supervisory review function will begin in earnest during
the third quarter of the current fiscal year.
Beginning
with the Form 10-QSB for the quarterly period ended March 31, 2005, filed with
the SEC on May 16, 2005, the Company included additional disclosure in the
section addressing disclosure controls and procedures to describe the nature and
remediation of these material weaknesses.
Comment
No. 8
2005-05-10 - UPLOAD - VERU INC.
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
Mail Stop 0510
May 10, 2005
By U.S. Mail and facsimile
Mr. Robert R. Zic
Principal Accounting Officer
The Female Health Company
515 North State Street, Suite 2225
Chicago, IL 60610
Re: The Female Health Company
Form 10-KSB for the year ended September 30, 2004
File No. 1-13602
Dear Mr. Zic:
We have reviewed your filings and have the following
comments.
Where indicated, we think you should revise your document in
response
to these comments. If you disagree, we will consider your
explanation as to why our comment is inapplicable or a revision is
unnecessary. Please be as detailed as necessary in your
explanation.
In some of our comments, we may ask you to provide us with
supplemental information so we may better understand your
disclosure.
After reviewing this information, we may or may not raise
additional
comments.
Please understand that the purpose of our review process is
to
assist you in your compliance with the applicable disclosure
requirements and to enhance the overall disclosure in your filing.
We look forward to working with you in these respects. We welcome
any questions you may have about our comments or on any other
aspect
of our review. Feel free to call us at the telephone numbers
listed
at the end of this letter.
Form 10-KSB for the Year Ended September 30, 2004
Note 1 - Nature of Business and Significant Accounting Policies -
Revenue Recognition
1. As indicated in your accounts receivable accounting policy, we
note that you offer a right of product returns from customers in
connection with unsold product which has expired or is expected to
expire before it is sold. Address for us supplementally how you
have
determined that you can reasonably estimate the amount of future
returns as required by paragraph 6f of SFAS 48. In this regard,
address the factors set forth in paragraph 8 of SFAS 48 and
address
whether those factors impair you ability to make a reasonable
estimate of returns. In particular, please tell us how you
estimate
the returns of new customers which you have no previous
relationship.
Also tell us what the estimated life of your product is and how
you
determine whether items may be returned due to expiration.
Clarify
in your revenue recognition policy that revenue is recorded net of
such estimated returns.
2. Address for us supplementally and revise your disclosures as
appropriate to address those instances where you have recognized
revenue other than at shipment.
Note 1 - Nature of Business and Significant Accounting Policies -
Earnings per Share
3. In future filings disclose the number of incremental common
shares
issuable upon conversion of your convertible preferred stock or
convertible debt and the exercise of stock options and warrants
that
were not included in diluted earnings per share because their
effect
would be anti-dilutive. Refer to paragraph 40c of SFAS 128.
Note 1 - Nature of Business and Significant Accounting Policies -
Other Comprehensive Income
4. Tell us supplementally and revise future filings to address the
$249,555 adjustment to other comprehensive loss. Tell us the
nature
of the adjustment, the terms and parties to the intercompany debt
and
the appropriateness of reflecting this adjustment in other
comprehensive income.
Note 8 - Common Stock - Stock Options Plans
5. As indicated by transactions reflected within your Consolidated
Statements of Stockholders` Equity, we note that you issued stock
through the cashless exercise of stock options and warrants.
Please
address supplementally and revise future filings to clarify your
accounting for stock and warrants granted with cashless exercise
features. Your response should identify the accounting literature
you relied on and address the guidance in Issue 48 of EITF 00-23:
Issues Related to the Accounting for Stock Compensation under APB
Opinion No. 25 and FASB Interpretation No. 44.
Item 8A. Controls and Procedures
6. We note your statement that the chief executive officer and the
principal accounting officer have concluded that the company`s
disclosure controls and procedures are effective "except as
discussed
below." Given the exceptions noted, it remains unclear whether
your
chief executive officer and principal accounting officer have
concluded that your disclosure controls and procedures are
effective.
Please revise your disclosure to state, in clear and unqualified
language, the conclusions reached by your chief executive officer
and
your principal accounting officer on the effectiveness of your
disclosure controls and procedures. For example, if true, you can
state that your disclosure controls and procedures are effective
including consideration of the identified matters, so long as you
provide appropriate disclosure explaining how the disclosure
controls
and procedures were determined to be effective in light of the
identified matters. Or, if true, you can state that given the
identified matters, your disclosure controls and procedures are
not
effective. You should not, however, state the conclusion in your
current disclosure, which appears to state that your disclosure
controls and procedures are effective except to the extent that
they
are not effective.
7. Disclose in greater detail the nature of the material
weaknesses
identified in your disclosure. In this regard, also revise to
disclose the specific steps that the company has taken, if any, to
remediate the material weaknesses.
8. Disclose when the material weaknesses were identified, by whom
they were identified and when the material weaknesses began. In
addition, to the extent that the material weaknesses began prior
to
the fourth quarter of fiscal 2004, disclose whether, in light of
what
they know now regarding the existence of the material weaknesses,
the
officers continue to believe that the financial statements
covering
prior periods are materially correct.
9. We note your disclosure regarding your disclosure controls and
procedures centers around whether the controls were effective in
timely alerting your Chief Executive Officer and Principal
Accounting
Officer to "material information relating to the Company required
to
be included in the Company`s periodic filings." In future
filings,
please revise your disclosure to clarify, if true, that your
officers
concluded that your disclosure controls and procedures are
effective
to ensure that information required to be disclosed by you in the
reports that you file or submit under the Exchange Act is
recorded,
processed, summarized and reported, within the time periods
specified
in the Commission`s rules and forms and to ensure that information
required to be disclosed by the company in the reports that it
files
or submits under the Exchange Act is accumulated and communicated
to
your management, including its principal executive and principal
financial officers, or persons performing similar functions, as
appropriate to allow timely decisions regarding required
disclosure.
Otherwise, please simply conclude that your disclosure controls
and
procedures are effective or ineffective, whichever the case may
be.
Address this comment as it relates to your disclosures under Item
4.
Controls and Procedures included in your Form 10-QSB for the
quarter
ended December 31, 2004.
* * *
Please respond to these comments within 10 business days, or
tell us when you will provide us with a response. Please provide
us
with a supplemental response letter that keys your responses to
our
comments and provides any requested supplemental information.
Detailed letters greatly facilitate our review. Please file your
supplemental response on EDGAR as a correspondence file. Please
understand that we may have additional comments after reviewing
your
responses to our comments.
We urge all persons who are responsible for the accuracy and
adequacy of the disclosure in the filings reviewed by the staff to
be
certain that they have provided all information investors require.
Since the company and its management are in possession of all
facts
relating to a company`s disclosure, they are responsible for the
accuracy and adequacy of the disclosures they have made.
In connection with responding to our comments, please
provide,
in writing, a statement from the company acknowledging that:
* the company is responsible for the adequacy and accuracy of the
disclosure in their filings;
* staff comments or changes to disclosure in response to staff
comments do not foreclose the Commission from taking any action
with
respect to the filing; and
* the company may not assert staff comments as a defense in any
proceeding initiated by the Commission or any person under the
federal securities laws of the United States.
In addition, please be advised that the Division of
Enforcement
has access to all information you provide to the staff of the
Division of Corporation Finance in our review of your filing or in
response to our comments on your filing.
If you have any questions regarding these comments, please
direct them to Patricia Armelin, Staff Accountant, at (202) 824-
5563,
Jeanne Baker, Assistant Chief Accountant, at (202) 942-1835 or, in
their absence, to the undersigned at (202) 824-5373.
.
Sincerely,
John Cash
Accounting Branch Chief
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Mr. Robert R. Zic
May 10, 2005
Page 1 of 4
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549-0510
DIVISION OF
CORPORATION FINANCE
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