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): SEPTEMBER 7, 2001 HALSEY DRUG CO., INC. 695 NO. PERRYVILLE ROAD, ROCKFORD, ILLINOIS (815-399-2060) Incorporated under the laws of Commission File Number I.R.S. Employer Identification Number State of New York 1-10113 11-0853640
2 ITEM 5 OTHER EVENTS On September 7, 2001, the Company announced that the U.S. Drug Enforcement Administration ("DEA") has filed a notice in the Federal Register regarding the Company's application for registration to manufacture Schedule II controlled substances. The Company, which has previously received approval from the DEA to manufacture Schedule III-N controlled substances at its Culver, Indiana facility, intends immediately to commence the installation of the necessary additional security measures in preparation for the anticipated DEA inspection in sixty days. If the application is approved, of which there can be no assurance, the Company would begin manufacturing certain controlled substance active ingredients for use in the manufacture of pain management products. In a related announcement, on September 7, 2001, the Company announced that the DEA has filed a notice in the Federal Register regarding the Company's application for registration to import certain controlled substances. If the application is approved, of which there can be no assurance, the Company would be one of only a very small number of companies allowed to directly import raw materials for processing into controlled substances. ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS. (c) Exhibits Exhibit No. Description ----------- ----------- 99.1 Press release dated September 7, 2001 announcing the Company is seeking registration from the DEA to manufacture Schedule II controlled substances. 99.2 Press release dated September 7, 2001 announcing the Company is seeking registration from the DEA to import controlled substances.
3 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 thereunto duly authorized. HALSEY DRUG CO., INC. By: /s/ Michael Reicher ------------------------------------------- Michael Reicher President and Chief Executive Officer Date: September 7, 2001
1 Exhibit 99.1 Contact: Halsey Pharmaceuticals Investor Relations - Peter A. Clemens, Vice President & CFO (815) 399-2060 FOR IMMEDIATE RELEASE HALSEY PHARMACEUTICALS ANNOUNCES FEDERAL REGISTER NOTICE Company Seeks Registration from DEA to Manufacture Schedule II Controlled Substances Rockford, Il., September 7, 2001, Halsey Pharmaceuticals (OTCBB-HDGC) today announced that the U.S. Drug Enforcement Administration ("DEA") has filed a notice in the Federal Register regarding the Company's application for registration to manufacture Schedule II controlled substances. Under established guidelines, interested parties have sixty days to respond to the Company's application once this notice has been published. The Company, which has previously received approval from the DEA to manufacture Schedule III-N controlled substances at its Culver, Indiana facility, intends immediately to commence the installation of the necessary additional security measures in preparation for the anticipated DEA inspection in sixty days. If the application is approved, of which there can be no assurance, Halsey would begin manufacturing certain controlled substance active ingredients for use in the manufacture of pain management products. "In prior disclosures we have spoken about our strategic plan to utilize the unique manufacturing capabilities of our active pharmaceutical ingredient ("API") facility in Indiana to produce controlled substances. Obtaining the necessary DEA registrations are of course key to executing this plan," said Michael K. Reicher, Chairman and CEO. "Today's announcement indicates we are progressing toward our overall goal of becoming an important manufacturer of API's and finished dosage form products in the $2.5 billion U.S. pain management market." Halsey Pharmaceuticals, together with its subsidiaries, is an emerging pharmaceutical company specializing in innovative drug development. The statements in this press release are forward looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward looking statements involve risk and uncertainties which may affect Halsey's business prospects, including economic, competitive, governmental, technological and other factors discussed in filings with the Securities and Exchange Commission.
2 This and past press releases for Halsey Pharmaceuticals are available at Halsey's web site at www.halseydrug.com.
1 Exhibit 99.2 Contact: Halsey Pharmaceuticals Investor Relations - Peter A. Clemens, Vice President & CFO (815) 399-2060 FOR IMMEDIATE RELEASE HALSEY PHARMACEUTICALS ANNOUNCES FEDERAL REGISTER NOTICE Company Seeks Registration from DEA to Import Controlled Substances Rockford, Il., September 7, 2001, Halsey Pharmaceuticals (OTCBB-HDGC) today announced that the U.S. Drug Enforcement Administration ("DEA") has filed a notice in the Federal Register regarding the Company's application for registration to import certain controlled substances. Under established guidelines, interested parties have thirty days to respond to the Company's application once this notice has been published. If the application is approved, of which there can be no assurance, Halsey would be one of only a very small number of companies allowed to directly import raw materials for processing into controlled substances. Halsey Pharmaceuticals, together with its subsidiaries, is an emerging pharmaceutical company specializing in innovative drug development. The statements in this press release are forward looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward looking statements involve risk and uncertainties which may affect Halsey's business prospects, including economic, competitive, governmental, technological and other factors discussed in filings with the Securities and Exchange Commission. This and past press releases for Halsey Pharmaceuticals are available at Halsey's web site at www.halseydrug.com.