-----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, AKeShWHRG9p80ObypMln4TbwD4LLIdFNCOaKEma9P9GyeklV1SJc835rsEnh1RoR BTK13X982K7VrhXHnnyK3g== /in/edgar/work/0000950137-00-004699/0000950137-00-004699.txt : 20001114 0000950137-00-004699.hdr.sgml : 20001114 ACCESSION NUMBER: 0000950137-00-004699 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20001108 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 20001113 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PERRIGO CO CENTRAL INDEX KEY: 0000820096 STANDARD INDUSTRIAL CLASSIFICATION: [2834 ] IRS NUMBER: 382799573 STATE OF INCORPORATION: MI FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 8-K SEC ACT: SEC FILE NUMBER: 000-19725 FILM NUMBER: 757783 BUSINESS ADDRESS: STREET 1: 515 EASTERN AVENUE CITY: ALLEGAN STATE: MI ZIP: 49010 BUSINESS PHONE: 6166738451 MAIL ADDRESS: STREET 1: 515 EASTERN AVENUE CITY: ALLEGAN STATE: MI ZIP: 49010 8-K 1 c58429e8-k.txt CURRENT REPORT 1 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 Date of Report (Date of earliest event reported): November 8, 2000 PERRIGO COMPANY -------------------------------------------------- (Exact name of registrant as specified in charter) MICHIGAN 0-19725 38-2799573 - --------------- ------------ ------------------ (State of other (Commission (I.R.S. Employer Jurisdiction of File Number) Identification Incorporation) Number) 515 Eastern Avenue, Allegan, Michigan 49010 - ------------------------------------------ ----------- (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (616) 673-8451 - -------------- 2 ITEM 5. Other Events The Perrigo Company issued a press release on November 8, 2000 announcing that in response to recommendations from the Food and Drug Administration (FDA) it has halted shipments of all products containing the ingredient Phenylpropanolamine (PPA), effective immediately. The press release issued on November 8 is presented as Exhibit 99. Certain statements in this press release are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and are subject to the safe harbor created thereby. Please refer to pages 23-27 of the Company's Form 10-K for the year ended July 1, 2000 for a discussion of certain important factors that relate to forward-looking statements contained in this press release. Although the Company believes that the expectations reflected in any such forward-looking statements are reasonable, it can give no assurance that such expectations will prove to be correct. 3 ITEM 7(c). Exhibits Exhibit 99 Press Release issued November 8, 2000 4 SIGNATURES Pursuant to the requirement 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. PERRIGO COMPANY (Registrant) By: /s/ Douglas R. Schrank ---------------------------------- Dated: November 8, 2000 Douglas R. Schrank Executive Vice President and Chief Financial Officer 5 Exhibit Index Exhibit 99 Press Release EX-99 2 c58429ex99.txt PRESS RELEASE 1 [PERRIGO LOGO] NEWS RELEASE [PERRIGO LETTERHEAD] FOR IMMEDIATE RELEASE PERRIGO COMPANY DISCONTINUING THE MARKETING OF PRODUCTS CONTAINING PHENYLPROPANOLAMINE HYDROCHLORIDE (PPA) ALLEGAN, Michigan, -- November 8, 2000 -- The Perrigo Company (Nasdaq: PRGO), the nation's largest manufacturer of over-the-counter (OTC) and nutritional products for the store brand market, today announced that in response to recommendations from the Food and Drug Administration (FDA) it has halted shipments of all products containing the ingredient Phenylpropanolamine (PPA), effective immediately. The ingredient is used in diet aids and in cough and cold products that Perrigo manufacturers as store brand equivalents to products such as Dexatrim(R), Dimetapp(R), Robitussin(R) and Triaminic(R). Following the Nonprescription Drug Advisory Committee's recommendation that PPA should no longer be considered safe, the FDA on November 6, 2000 took steps to remove PPA from all drug products. The FDA notified companies that they intend to classify PPA as nonmonograph, or not generally recognized as safe and effective for OTC use. At the same time, FDA also requested that companies voluntarily discontinue marketing any products containing PPA. Further, FDA issued a public health advisory concerning the risks associated with PPA. David T. Gibbons, Perrigo President and Chief Executive Officer, stated, "Although PPA has proved to be a safe and effective ingredient in our OTC medications for nearly 40 years, the Company's first priority is consumers' health. For this reason, Perrigo is taking actions in step with FDA's recommendations." The value of Perrigo's on-hand inventories and the cost of disposal and reformulation is estimated to be between $15 and $19 million, resulting in a charge of $0.13 to $0.16 per share in the fiscal year second quarter ending December 30, 2000. In addition, the effect of not having replacement products available for sale will reduce earnings an additional $0.05 to $0.06 during the remainder of fiscal 2001, with $0.02 of that coming in the second quarter. The actual charges could be more or less than the current estimates. The Company had previously provided earnings guidance of $0.14 to $0.16 per share for the fiscal 2001 second quarter and $0.42 to $0.46 per share for the full year ending June 30, 2001. Mr. Gibbons concluded, "At this time, we foresee little or no long-term impact resulting from the discontinuance of products containing PPA since we will work as quickly as possible to reformulate the affected products. We anticipate the majority of these reformulated products to be ready in time for next year's cough and cold season." Perrigo Company is the nation's largest manufacturer of over-the-counter (non-prescription) pharmaceutical and nutritional products for the store brand market. Store brand products are sold by national and regional supermarket, drugstore and mass merchandise chains under their own labels and compete with nationally advertised brands. The Company's products include over-the-counter 2 pharmaceuticals, such as analgesics, cough and cold remedies, antacids, laxatives, feminine hygiene and smoking cessation products, and nutritional products, such as vitamins, nutritional supplements and nutritional drinks. Visit Perrigo on the Internet at http://www.perrigo.com. Note: Certain statements in this press release are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and are subject to the safe harbor created thereby. Please refer to pages 23-27 of the Company's Form 10-K for the year ended July 1, 2000 for a discussion of certain important factors that relate to forward-looking statements contained in this press release. Although the Company believes that the expectations reflected in any such forward-looking statements are reasonable, it can give no assurance that such expectations will prove to be correct. ### -----END PRIVACY-ENHANCED MESSAGE-----