-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, NKV9j62DaxSTCb/OidjlkgzM481BHkzWC+9GyM8sci2ig3ajUGe1uCTsKjil4EkU GyQ79fHsDpwz8MFuBrcYaQ== 0001068800-07-001284.txt : 20070516 0001068800-07-001284.hdr.sgml : 20070516 20070516162854 ACCESSION NUMBER: 0001068800-07-001284 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20070516 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070516 DATE AS OF CHANGE: 20070516 FILER: COMPANY DATA: COMPANY CONFORMED NAME: KV PHARMACEUTICAL CO /DE/ CENTRAL INDEX KEY: 0000057055 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 430618919 STATE OF INCORPORATION: DE FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-09601 FILM NUMBER: 07858154 BUSINESS ADDRESS: STREET 1: 2503 S HANLEY RD CITY: ST LOUIS STATE: MO ZIP: 63144 BUSINESS PHONE: 3146456600 MAIL ADDRESS: STREET 1: 2503 S HANLEY RD CITY: ST LOUIS STATE: MO ZIP: 63144 8-K 1 kv8k.txt =============================================================================== UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ---------------------------------- FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 1-9601 Date of Report (date of earliest event reported): May 16, 2007 K-V PHARMACEUTICAL COMPANY (Exact name of registrant as specified in its charter) DELAWARE 43-0618919 (State or other jurisdiction of (I.R.S. Employer Identification No.) incorporation or organization) 2503 SOUTH HANLEY ROAD ST. LOUIS, MISSOURI 63144 (Address of principal executive offices) (Zip Code) (314) 645-6600 (Registrant's telephone number, including area code) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: | | Written communications pursuant to Rule 425 under the Securities Act. | | Soliciting material pursuant to Rule 14a-12 under the Exchange Act. | | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act. | | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act. =============================================================================== ITEM 7.01 REGULATION FD DISCLOSURE. Attached and incorporated herein by reference as Exhibit 99 is a press release issued by K-V Pharmaceutical Company (the "Company") announcing that the Company has completed its previously announced transaction with VIVUS, Inc. for the sublicense of exclusive rights and purchase of assets related to EvaMist(TM). The information in this Form 8-K, including Exhibit 99 attached hereto, is being furnished under Regulation FD and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended. The Company has posted this Form 8-K on its internet website at www.kvpharmaceutical.com. A copy of the press release is attached hereto as Exhibit 99. ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS. (d) The following exhibit is furnished as part of this report: Exhibit Number Description -------------- ----------- 99 Press Release dated May 16, 2007, issued by K-V Pharmaceutical Company * * * -2- SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Dated: May 16, 2007 K-V PHARMACEUTICAL COMPANY By: /s/ Richard H. Chibnall ------------------------- Richard H. Chibnall Vice President, Finance -3- EX-99 2 ex99.txt EXHIBIT 99 KV PHARMACEUTICAL COMPANY CONTACT: CATHERINE M. BIFFIGNANI VICE PRESIDENT, INVESTOR RELATIONS 314-645-6600 FOR IMMEDIATE RELEASE [KV PHARMACEUTICAL logo] KV PHARMACEUTICAL COMPANY COMPLETES ACQUISITION OF U.S. RIGHTS TO EVAMIST(TM) St. Louis, MO, May 16, 2007 - KV Pharmaceutical Company (NYSE: KVa/KVb) reported today that it has completed its previously announced transaction with VIVUS, Inc. for the sublicense of exclusive rights and purchase of assets related to EvaMist(TM). Under the terms of the all-cash transaction, KV agreed to pay $10 million at closing and to make an additional payment of approximately $140 million at the time of final approval from the U.S. Food and Drug Administration. There are also two, one-time milestone payments tied to the net sales of the product. $10 million will be paid if the product achieves $100 million in net sales in a market year and up to $20 million will be paid if the product achieves $200 million in net sales in a market year. EvaMist(TM), which has completed Phase III clinical trials, is a patented estradiol transdermal spray that offers a novel approach to the treatment of vasomotor symptoms associated with menopause. Upon approval, EvaMist(TM) is expected to significantly augment the women's health offerings of KV's branded subsidiary, Ther-Rx Corporation. With a PDUFA action date of July 29, 2007 from the FDA, KV currently expects that the product may be approved and launched during the second half of its fiscal 2008 which began April 1, 2007. The product targets an annual $1.3 billion estrogen replacement market (Source: IMS NSP Audit, January 2006-December 2006) where physicians and patients are seeking an effective and safe, low-dose estrogen product. The Company estimates EvaMist(TM)'s U.S. market potential to be approximately $125 million in peak, annual net sales with gross margins consistent with those currently being achieved by Ther-Rx Corporation. KV believes EvaMist(TM) will offer therapeutic effectiveness with estradiol dosing that is among the lowest available for this indication in a manner that is also cosmetically appealing for women. ABOUT KV PHARMACEUTICAL COMPANY - ------------------------------- KV Pharmaceutical Company is a fully integrated specialty pharmaceutical company that develops, manufactures and markets and acquires technology- distinguished branded and generic/non-branded prescription pharmaceutical products. The Company markets its technology distinguished products through ETHEX Corporation, a national leader in pharmaceuticals that compete with branded products, and Ther-Rx Corporation, its emerging branded drug subsidiary. For further information about KV Pharmaceutical Company, please visit the Company's corporate website at www.kvpharmaceutical.com. ABOUT VIVUS - ----------- VIVUS, Inc. is a pharmaceutical company dedicated to the development and commercialization of next-generation therapeutic products addressing obesity and sexual health. VIVUS has three products that are positioned to enter Phase 3 clinical trials, and one product currently under NDA review by the FDA. The investigational pipeline includes: Qnexa(TM), for which a Phase 2 study has been completed for the treatment of obesity; Testosterone MDTS(R), for which a Phase 2 study has been completed for the treatment of Hypoactive Sexual Desire Disorder (HSDD); EvaMist(TM), for which a Phase 3 study has been completed and an NDA submitted for the treatment of menopausal symptoms; and avanafil, for which a Phase 2 study has been completed for the treatment of erectile dysfunction (ED). MUSE(R) is approved and currently on the market for the treatment of ED. For more information on clinical trials and products, please visit the company's web site at www.vivus.com. SAFE HARBOR - ----------- The information in this release may contain various forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 ("PSLRA") and which may be based on or include assumptions concerning KV's operations, future results and prospects. Such statements may be identified by the use of words like "plans", "expect", "aim", "believe", "projects", "anticipate", "commit", "intend", "estimate", "will", "should", "could" and other expressions that indicate future events and trends. All statements that address expectations or projections about the future, including without limitation, statements about the Company's strategy for growth, product development, regulatory approvals, market position, acquisitions, revenues, expenditures and other financial results, are forward-looking statements. All forward-looking statements are based on current expectations and are subject to risk and uncertainties. In connection with the "safe harbor" provisions, KV provides the following cautionary statements identifying important economic, political and technology factors which, among others, could cause actual results or events to differ materially from those set forth or implied by the forward-looking statements and related assumptions. Such factors include (but are not limited to) the following: (1) changes in the current and future business environment, including interest rates and capital and consumer spending; (2) the difficulty of predicting FDA approvals, including timing, and that any period of exclusivity may not be realized; (3) acceptance and demand for new pharmaceutical products; (4) the impact of competitive products and pricing, including as a result of so-called authorized-generic drugs; (5) new product development and launch, including the possibility that any product launch may be delayed or that product acceptance may be less than anticipated; (6) reliance on key strategic alliances; (7) the availability of raw materials; (8) the regulatory environment, including regulatory agency and judicial actions and changes in applicable law or regulations; (9) fluctuations in operating results; (10) the difficulty of predicting international regulatory approval, including timing; (11) the difficulty of predicting the pattern of inventory movements by the Company's customers; (12) the impact of competitive response to the Company's sales, marketing and strategic efforts; (13) risks that the Company may not ultimately prevail in litigation; (14) the outcome of a previously disclosed inquiry into the effect of certain stock option grants by an independent committee of the Company's Audit Committee and the completion of the interim financial statements for the second and third quarters of fiscal 2007; and (15) the risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. This discussion is by no means exhaustive, but is designed to highlight important factors that may impact the Company's outlook. We are under no obligation to update any of the forward-looking statements after the date of this report. -----END PRIVACY-ENHANCED MESSAGE-----