UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-8
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
K-V PHARMACEUTICAL COMPANY
(Exact name of registrant as specified in its charter)
Delaware | 43-0618917 | |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification Number) | |
2280 Schuetz Road St. Louis, MO |
63146 | |
(Address of principal executive offices) | (Zip Code) |
K-V PHARMACEUTICAL
LONG-TERM INCENTIVE PLAN
GREGORY J. DIVIS, JR.
President and Chief Executive Officer
K-V Pharmaceutical Company
2280 Schuetz Road
St. Louis, MO 63146
(Name and address of agent for service)
With copy to:
PATRICK J. CHRISTMAS
General Counsel and Secretary
K-V Pharmaceutical Company
2280 Schuetz Road
St. Louis, MO 63146
Telephone number, including area code, of agent for service: (314) 645-6600
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ¨ | Accelerated filer | x | |||
Non-accelerated filer | ¨ (Do not check if a smaller reporting company) | Smaller Reporting Company | ¨ |
CALCULATION OF REGISTRATION FEE
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Title of Securities to be Registered |
Amount to be Registered |
Proposed Maximum Offering Price Per Share(2) |
Proposed Maximum Offering Price(2) |
Amount of Registration Fee | ||||
Class A Common Stock, $0.01 par value per share |
4,000,000 shares(1) | $1.49 | $5,940,000 | $680.72 | ||||
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(1) | Pursuant to Rule 416(a), this registration statement also covers any additional securities that may be offered or issued in connection with any stock split, stock dividend or similar transaction |
(2) | Estimated solely for purposes of computing the Registration Fee pursuant to the provisions of Section 457(h), based upon the average of the high and low sale prices of Class A Common Stock, $0.01 par value, of the Registrant as reported on the New York Stock Exchange on December 13, 2011. |
The undersigned registrant, K-V Pharmaceutical Company (the Company), hereby files this Registration Statement on Form S-8 to register 4,000,000 shares of the Companys Class A Common Stock, par value $0.01 per share, for issuance to participants under the K-V Pharmaceutical Company Long-Term Incentive Plan.
PART II
INFORMATION REQUIRED IN THE REGISTRATION STATEMENT
Item 3. Incorporation of Certain Documents by Reference.
The following documents filed with the Securities and Exchange Commission are incorporated herein by reference:
(i) | The Companys Annual Report on Form 10-K for the fiscal year ended March 31, 2011, as amended by the Form 10-K/A filed December 8, 2011; |
(ii) | The Companys Quarterly Report on Form 10-Q for the quarters ended June 30, 2011, as amended by the Form 10-Q/A filed December 8, 2011, and September 30, 2011; |
(iii) | The Companys Current Reports on Form 8-K filed June 17, 2011, June 24, 2011, July 8, 2011, August 10, 2011, September 14, 2011, November 14, 2011, and December 12, 2011 (exclusive of Item 7.01 and exhibits); and |
(iv) | The description of the Companys Class A Common Stock which is contained in the Companys Registration Statement on Form 8-A, which was filed on March 22, 1999, including any amendments or reports filed for the purpose of updating such description. |
All documents filed by the Company pursuant to Sections 13(a), 13(c), 14 and 15(d) of the Securities Exchange Act of 1934, as amended, after the date of this Registration Statement and prior to the filing of a post-effective amendment which indicates that all securities offered hereby have been sold or which deregisters all securities remaining unsold, shall be deemed to be incorporated by reference in this Registration Statement and to be made a part hereof from the date of filing of such documents. Any statements contained herein or in a document incorporated herein by reference shall be deemed to be modified or superseded for purposes of this Registration Statement to the extent that a statement contained in a subsequently filed document incorporated herein by reference modifies or supersedes such document. Any statement so modified or superseded shall not be deemed, except as so modified or superseded, to constitute a part of this Registration Statement.
Where any document or part thereof is incorporated by reference in this Registration Statement, the Company will provide without charge to each person to whom a Prospectus with respect to the Plan is delivered, upon written or oral request of such person, a copy of any and all of the information incorporated by reference in this Registration Statement, excluding exhibits unless such exhibits are specifically incorporated by reference.
Item 4. Description of Securities.
Not applicable.
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Item 5. Interests of Name Experts and Counsel.
Not applicable.
Item 6. Indemnification of Directors and Officers.
Section 145 of the General Corporation Law of the State of Delaware (Section 145) permits indemnification by a corporation of certain officers, directors, employees and agents. Consistent therewith, Article IX of the Companys By-Laws (Article IX) requires that the Company indemnify all persons whom it may indemnify pursuant thereto to the fullest extent permitted by Section 145. Article IX also provides that expenses incurred by an officer or director of the Company, in defending a civil or criminal action, suit or proceeding, may be paid by the Company in advance of the final disposition of such action, suit or proceeding upon receipt of an undertaking by or on behalf of such officer or director to repay such amount if it shall ultimately be determined that he is not entitled to be indemnified by the Company as authorized. Such expenses incurred by other employees and agents of the Company may also be paid upon such terms and conditions, if any, as the board of directors, legal counsel or the Companys stockholders deem appropriate.
In addition, Article 12 of the Companys Amended Certificate of Incorporation provides that directors of the Company shall not be personally liable for monetary damages to the Company or its stockholders for a breach of fiduciary duty as a director, except for liability as a result of: (i) a breach of the directors duty of loyalty to the Company or its stockholders; (ii) acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law; (iii) an act related to the unlawful stock repurchase or payment of a dividend under Section 174 of Delaware General Corporation Law; and (iv) transactions from which the director derived an improper personal benefit.
Further, the Company has entered into indemnification agreements with certain directors and officers which requires the Company to indemnify them against certain liabilities which may arise by reason of his or her status or service as a director.
The Company maintains a policy of insurance under which the directors and officers of the Company are insured, subject to the limits of the policy, against certain losses arising from claims made against such directors and officers by reason of any acts or omissions covered under such policy in their respective capacities as directors or officers.
Item 7. Exemption From Registration Claimed.
Not applicable.
Item 8. Exhibits.
See Exhibit Index.
Item 9. Undertakings.
(a) | The undersigned registrant hereby undertakes: |
(1) To file, during any period in which offers and sales are being made, a post-effective amendment to this registration statement:
(i) To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;
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(ii) To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof), which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement;
(iii) To include any material information with respect to the plan of distribution previously disclosed in the registration statement or any material change to such information in the registration statement;
provided, however, that paragraphs (a)(1)(i) and (a)(1)(ii) do not apply if the registration statement is on Form S-3, Form S-8 or Form F-3, and the information required to be included in a post-effective amendment by those paragraphs is contained in periodic reports filed with or furnished to the Commission by the registrant pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934 that are incorporated by reference in the registration statement.
(2) That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
(3) To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.
(b) The undersigned registrant hereby undertakes that, for purposes of determining any liability under the Securities Act of 1933, each filing of the registrants annual report pursuant to Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plans annual report pursuant to Section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
(c) Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication of such issue.
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SIGNATURES
The Registrant. Pursuant to the requirements of the Securities Act of 1933, as amended, the Registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form S-8 and has duly caused this Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the County of St. Louis, State of Missouri, on December 19, 2011.
K-V PHARMACEUTICAL COMPANY (Registrant) | ||
By: | /s/ Gregory J. Divis, Jr. | |
Gregory J. Divis, Jr., President and Chief Executive Officer |
POWER OF ATTORNEY
We, the undersigned officers and directors of K-V Pharmaceutical Company, hereby severally and individually constitute and appoint Gregory J. Divis, Jr. and Thomas S. McHugh and each of them (with full power to act alone), the lawful attorneys and agents of each of us to execute in the name, place and stead of each of us (individually and in any capacity stated below) any and all amendments to this Registration Statement on Form S-8 and all instruments necessary or advisable in connection therewith and to file the same with the Securities and Exchange Commission, the said attorneys and agents to have the power to act with or without the others and to have full power and authority to do and perform in the name and on behalf of each of the undersigned every act whatsoever necessary or advisable to be done in the premises as fully and to all intents and purposes as any of the undersigned might or could do in person, and we hereby ratify and confirm our signatures as they may be signed by our said attorneys and agents to any and all such amendments and instruments.
Pursuant to the requirements of the Securities Act of 1933, as amended, this Registration Statement has been signed below by the following persons and in the capacities and on the dates indicated.
Signature |
Title |
Date | ||
/s/ Gregory J. Divis, Jr. Gregory J. Divis, Jr. |
President and Chief Executive Officer (Principal Executive Officer) |
12/19/2011 | ||
/s/ Thomas S. McHugh Thomas S. McHugh |
Chief Financial Officer (Principal Financial and Accounting Officer) |
12/19/2011 | ||
/s/ Gregory S. Bentley Gregory S. Bentley |
Director | 12/19/2011 | ||
/s/ Mark A. Dow Mark A. Dow |
Director | 12/19/2011 | ||
/s/ Joseph D. Lehrer Joseph D. Lehrer |
Director | 12/19/2011 |
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Signature |
Title |
Date | ||
/s/ David S. Hermelin David S. Hermelin |
Director | 12/19/2011 | ||
/s/ Ana I. Stancic Ana I. Stancic |
Director | 12/19/2011 | ||
/s/ Robert E. Baldini Robert E. Baldini |
Director | 12/19/2011 | ||
/s/ David Sidransky, M.D. David Sidransky, M.D. |
Director | 12/19/2011 |
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EXHIBIT INDEX
Exhibit |
Description | |
4.1 | Certificate of Incorporation of the Company, as amended through September 5, 2008, filed as Exhibit 3.1 to the Companys Annual Report on Form 10-K for the fiscal year ended March 31, 2009, is incorporated herein by reference. | |
4.2 | By-Laws of the Company, as amended through December 29, 2009, which was filed as Exhibit 3.2 to the Companys Current Report on Form 8-K filed January 4, 2010, are incorporated herein by reference. | |
5.1 | Opinion of Thompson Coburn LLP as to the legality of the securities being registered. | |
23.1 | Consent of BDO USA, LLP. | |
23.2 | Consent of KPMG LLP. | |
23.3 | Consent of Thompson Coburn LLP (included in Exhibit 5.1). | |
24.1 | Power of Attorney (set forth on signature page hereto). | |
99.1 | K-V Pharmaceutical Long-Term Incentive Plan, filed as Appendix A to the Companys Proxy Statement on Schedule 14A filed by the Company on July 26, 2011, is incorporated herein by reference. |
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Exhibit 5.1
December 16, 2011
K-V Pharmaceutical Company
2280 Schuetz Road
St. Louis, MO 63146
Re: | Registration Statement on Form S-8 to register 4,000,000 shares of the Companys Class A Common Stock, par value $0.01 per share, for issuance under the K-V Pharmaceutical Company Long-Term Incentive Plan |
Ladies and Gentlemen:
With reference to the Registration Statement on Form S-8 (the Registration Statement) being filed with the Securities and Exchange Commission pursuant to the Securities Act of 1933, as amended, on December 16, 2011, by K-V Pharmaceutical Company, a Delaware corporation (the Company), pertaining to the proposed issuance by the Company of an aggregate of up to 4,000,000 shares of the Companys Class A Common Stock, par value $0.01 per share (the Shares), pursuant to the Companys Long-Term Incentive Plan (the Plan), we have examined such corporate records of the Company, such laws and such other information as we have deemed relevant, including the Registration Statement, an executed copy of the Opinion Certificate dated as of the date hereof executed by Patrick J. Christmas, Vice President, General Counsel and Secretary of the Company, the Certificate of Incorporation of the Company, as amended to date, the By-Laws of the Company, as amended to date, certain resolutions and actions adopted by the Board of Directors and stockholders relating to such issuance, the written documents constituting the Plan, and statements we have received from officers and representatives of the Company.
In examining such materials and in delivering this opinion, we have assumed the genuineness of all signatures, the authenticity of all documents submitted to us as originals, the conformity to the originals of all documents submitted to us as certified, photostatic or conformed copies, and the authenticity of the originals of all such latter documents, and the correctness of statements submitted to us by officers and representatives of the Company.
Based solely on the foregoing and subject to the qualifications set forth herein, we are of the opinion that the Shares have been duly authorized and, when issued by the Company in accordance with the Plan, will be duly and validly issued and will be fully paid and nonassessable.
We hereby consent to the filing of this opinion as an exhibit to the Registration Statement. We further consent to the filing of copies of this opinion with agencies of such states and other jurisdictions as you deem necessary in the course of complying with the laws of the states and jurisdictions regarding the sale and issuance of the Shares.
Very truly yours, |
/s/ THOMPSON COBURN LLP |
OPINION CERTIFICATE
This Opinion Certificate (this Certificate) is executed and delivered as of December 16, 2011, by Patrick J. Christmas, Vice President, General Counsel and Secretary of K-V Pharmaceutical Company, a Delaware corporation (the Company).
The undersigned understands and acknowledges that Thompson Coburn LLP, as counsel to the Company, will be delivering a legal opinion in connection with the Companys filing of the Registration Statement on Form S-8 (the Registration Statement) to register 4,000,000 shares of the Companys Class A Common Stock, par value $0.01 per share, for issuance to participants under the K-V Pharmaceutical Company Long-Term Incentive Plan. The undersigned is making the factual statements and representations in this Certificate with respect to the Company in order to induce Thompson Coburn LLP to render its opinion.
The undersigned represents that:
1. The Certificate of Incorporation of the Company filed as Exhibit 3.1 to the Companys Annual Report on Form 10-K for the fiscal year ended March 31, 2009 is a true, complete and correct copy of the Certificate of Incorporation of the Company, as amended to date (the Certificate), which is in full force and effect as of the date hereof. No amendment to the Certificate has been authorized or approved by the Board of Directors of the Company or the stockholders of the Company or filed in the office of the Secretary of State of the State of Delaware.
2. The By-Laws of the Company filed as Exhibit 3.2 to the Companys Current Report on Form 8-K filed January 4, 2010 are true, complete and correct copies of the By-Laws of the Company, as amended to date, which are in full force and effect as of the date hereof. No amendments to such Bylaws have been authorized or approved by the Board of Directors of the Company or the stockholders of the Company.
3. Attached hereto as Exhibit A are true, complete and correct copies of resolutions duly adopted by the Board of Directors and the stockholders of the Company, and such resolutions have not been amended or revoked since the date thereof.
[Signature Page Follows]
IN WITNESS WHEREOF, I have signed this Certificate as of the 16th day of December, 2011.
By: | /s/ Patrick J. Christmas | |
Patrick J. Christmas | ||
Vice President, General Counsel and Secretary of K-V Pharmaceutical Company |
Exhibit A
Resolutions of the Board of Directors and Stockholders of the Company
K-V PHARMACEUTICAL COMPANY
BOARD OF DIRECTOR MEETING
RESOLUTION
June 24, 2011
Long-Term Incentive Plan
Dr. Sidransky then presented the Long-Term Incentive Plan (LTIP) for the Boards review. Dr. Sidransky explained that the LTIP, if approved by the Board and the shareholders of the Company at the upcoming Annual Meeting, would replace the Companys 2001 Incentive Stock Option Plan, which expires in January 2012. Dr. Sidransky reviewed the details and the necessity of the LTIP, which would assist to properly attract, incentivize and retain employees and senior executives. Mr. Proost and Mr. Christmas answered questions from various Board members regarding the LTIP.
Upon motion duly made and seconded, all the Directors in attendance unanimously approved the following resolution:
RESOLVED, that the Long-Term Incentive Plan attached hereto as Exhibit C is hereby approved.
K-V PHARMACEUTICAL COMPANY
BOARD OF DIRECTORS
RESOLUTIONS
September 8, 2011
Long-Term Incentive Plan
WHEREAS, on June 24, 2011, the Board of Directors approved the K-V Pharmaceutical Company Long-Term Incentive Plan (the Plan); and
WHEREAS, the Companys stockholders approved the Plan at the annual meeting held on September 8, 2011; and
WHEREAS, the Board has determined that it is advisable and in the best interests of the Company and its stockholders to provide for the reservation of shares issuable pursuant to the Plan, the registration of the Plan shares with the Securities and Exchange Commission (the SEC) and the listing of the Plan shares on the New York Stock Exchange (the Exchange).
NOW, THEREFORE BE IT:
RESOLVED, that 4,000,000 shares of Class A Common Stock, par value $0.01 per share, of the Company (the Class A Common Stock), shall be set aside and reserved for issuance pursuant to the Plan, subject to adjustments as may be required in accordance with the terms of the Plan;
FURTHER RESOLVED that all such shares of Class A Common Stock, when issued pursuant to the terms of awards made under the Plan, shall be duly and validly issued, fully paid and non-assessable shares of capital stock of the Company;
FURTHER RESOLVED, that, the President and Chief Executive Officer and the Chief Financial Officer (the Proper Officers) be, and each of them hereby is, authorized, empowered and directed, in the name of and on behalf of the Company, to execute and cause to be filed with the Securities and Exchange Commission (the SEC) a registration statement on Form S-8 (the Registration Statement) for the purpose of registering under the Securities Act of 1933, as amended (the Securities Act), the shares of Class A Common Stock issuable under the Plan;
FURTHER RESOLVED, that the Proper Officers be, and each of them hereby is, authorized, empowered and directed to cause to be executed and filed with the SEC such further amendments or supplements to the Registration Statement as such officers may deem necessary or desirable, or as may be required by the SEC, and to take such other actions and execute such other documents as any of them may deem necessary or appropriate to cause the Registration Statement to become effective under the Securities Act and the rules and regulations thereunder;
FURTHER RESOLVED, that the Proper Officers be, and each of them hereby is, authorized to cause the Company to apply to the Exchange, for the listing of the Class A Common Stock and to appear before the appropriate officials of the Exchange, with authority (1) to execute in the name and on behalf of the Company and file with the Exchange an appropriate listing application and all agreements and documents (including indemnity agreements) as such Proper Officer considers necessary or desirable to secure the listing, and (2) to make any changes in the listing application or agreements or documents as are required to satisfy the requirements of the Exchange for the listing;
FURTHER RESOLVED, that the Proper Officers be, and each of them hereby is, authorized, empowered and directed to cause to be prepared and distributed to holders of equity awards granted under the Plan such document or documents as may be required to constitute a prospectus meeting the requirements of Section 10(a) of the Securities Act with respect to the issuance of the Class A Common Stock subject to the Registration Statement;
FURTHER RESOLVED, that each officer and director who may be required to sign and execute the Registration Statement, or any amendment thereto or document in connection therewith (whether on behalf of the Company, or as an officer or director of the Company, or otherwise), be, and each of them hereby is, authorized and empowered to execute a power of attorney appointing each of the Proper Officers his true and lawful attorneys each with power of substitution and resubstitution to sign in his or her name, place and stead in any and all such capacities the Registration Statement and any and all amendments thereto (including post-effective amendments) and documents in connection therewith, and to file the same with the Commission, each said attorney to have full power and authority to do and perform, in the name of and on behalf of each of said officers and directors of the Company who shall have executed such a power of attorney, every act whatsoever which such attorney may deem necessary or desirable to be done in connection therewith, as fully and to all intents and purposes as such officer or director of the Company might or could do in person;
FURTHER RESOLVED, that, in connection with the Registration Statement, the Proper Officers be, and each of them hereby is, authorized, empowered and directed, in the name of and on behalf of the Company, to execute and file or cause to be filed such consents to service of process, powers of attorney, applications and other documents with any state authorities and to do such other things and acts as such officers may deem necessary or appropriate in order to register or qualify the Class A Common Stock for offer and sale under the securities or blue sky laws of any such state; provided, however, that the Company shall not qualify as a foreign corporation in any such state or consent to service of process in any such state other than with respect to claims arising under the securities laws of such state; and be it
FURTHER RESOLVED, that the Proper Officers be, and each of them hereby is, authorized, empowered and directed to cause the Company to pay any and all expenses and fees arising in connection with the registration of the shares of Class Common Stock on the Registration Statement under the Securities Act and any filing of any applications under the securities or blue sky laws of the various states and jurisdictions of the United States in connection with the foregoing resolutions.
K-V PHARMACEUTICAL COMPANY
STOCKHOLDERS ANNUAL MEETING
CERTIFICATION OF INSPECTOR OF ELECTIONS
September 8, 2011
I DO FURTHER CERTIFY that at said Stockholders Annual Meeting, a vote of the stockholders of the Company present in person or by proxy was taken by ballot to approve the K-V Pharmaceutical Long-Term Incentive Plan, and that the undersigned, as the Inspector appointed as aforesaid, decided upon the qualifications of the stockholders voting at said meeting, accepted the ballots of the stockholders and counted and determined the number of shares voted for, against or abstaining and do hereby declare that votes were cast as follows:
FOR |
AGAINST |
ABSTAIN |
NON-VOTES |
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8,229,685 | 179,785 | 5,848 | 1,736,326 | |||||||||||
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Exhibit 23.1
Consent of Independent Registered Public Accounting Firm
The Board of Directors
K-V Pharmaceutical Company
Bridgeton, Missouri
We hereby consent to the incorporation by reference in the prospectus constituting a part of this Registration Statement of our report dated June 10, 2011 (except for the 2011 and 2010 condensed consolidating financial information as presented in Note 26, which is as of July 8, 2011, and except for the effects of the restatement described in Note 1 which is as of December 8, 2011) relating to the 2011 and 2010 consolidated financial statements and financial statement schedule, and of our report dated June 10, 2011, except as to the effect of the restatement, which is dated December 8, 2011, related to the effectiveness of the Companys internal control over financial reporting, which appear in the Companys Amendment No. 1 to its Annual Report on Form 10-K/A for the year ended March 31, 2011.
Our report on the consolidated financial statements contains an explanatory paragraph regarding the Companys ability to continue as a going concern.
Our report on the effectiveness of internal control over financial reporting expresses an adverse opinion on the effectiveness of the Companys internal control over financial reporting as of March 31, 2011.
/s/ BDO USA, LLP
Chicago, Illinois
December 19, 2011
Exhibit 23.2
Consent of Independent Registered Public Accounting Firm
The Board of Directors
K-V Pharmaceutical Company:
We consent to the use of our report dated March 25, 2010, except as to note 23, which is as of June 10, 2011 and note 26, which is as of July 8, 2011, with respect to the consolidated statements of operations, comprehensive loss, shareholders equity (deficit) and cash flows of K-V Pharmaceutical Company and subsidiaries for the year ended March 31, 2009, and the related financial statement schedule for the year then ended, which report appears in the Current Report on Form 8-K dated July 8, 2011 and is incorporated by reference herein.
Our report dated March 25, 2010, except as to note 23, which is as of June 10, 2011 and note 26, which is as of July 8, 2011, on the consolidated financial statements contains an explanatory paragraph that states the Company has suspended the shipment of all products manufactured by the Company and must comply with a consent decree with the FDA before approved products can be reintroduced to the market. Significant negative impacts on operating results and cash flows from these actions including the potential inability of the Company to raise capital; suspension of manufacturing; significant uncertainties related to litigation and governmental inquiries; and debt covenant violations raise substantial doubt about the Companys ability to continue as a going concern. The consolidated financial statements and financial statement schedule do not include any adjustments that might result from the outcome of that uncertainty.
/s/ KPMG LLP
St. Louis, Missouri
December 19, 2011