-----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, GllzuoP+y30sxQVI1xny6yATWDAiV5KzKITz7BYTAHACVirotplV/FyFhgJXbHOo KFJUzNvzjMPdLbkMeIqNbA== 0000950152-03-005465.txt : 20030514 0000950152-03-005465.hdr.sgml : 20030514 20030514114457 ACCESSION NUMBER: 0000950152-03-005465 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20030513 ITEM INFORMATION: Financial statements and exhibits ITEM INFORMATION: Regulation FD Disclosure FILED AS OF DATE: 20030514 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SHEFFIELD PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000894158 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 133808303 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-12584 FILM NUMBER: 03697515 BUSINESS ADDRESS: STREET 1: 425 WOODSMILL RD CITY: ST LOUIS STATE: MO ZIP: 63017 BUSINESS PHONE: 3145799899 MAIL ADDRESS: STREET 1: 425 WOODSMILL RD CITY: ST LOUIS STATE: MO ZIP: 63017 FORMER COMPANY: FORMER CONFORMED NAME: SHEFFIELD MEDICAL TECHNOLOGIES INC DATE OF NAME CHANGE: 19940606 8-K 1 l01020ae8vk.txt SHEFFIELD PHARMACEUTICALS 8-K 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 Date of Report (Date of earliest event reported): MAY 13, 2003 SHEFFIELD PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) DELAWARE (State or other jurisdiction of incorporation) 1-12584 13-3808303 (Commission File Number) (I.R.S. Employer Identification No.) 3136 WINTON ROAD, SUITE 201, ROCHESTER, NEW YORK 14623 (Address of principal executive offices) (Zip Code)
(585) 292-0310 (Company's telephone number, including area code) (NOT APPLICABLE) (Former name or former address, if changed since last report) ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS (c) Exhibits EXHIBIT NUMBER DESCRIPTION -------------- ----------- 99.1 Press Release of Sheffield Pharmaceuticals, Inc. dated May 13, 2003 ITEM 9. REGULATION FD DISCLOSURE (INFORMATION FURNISHED PURSUANT TO ITEM 12, "DISCLOSURE OF RESULTS OF OPERATIONS AND FINANCIAL CONDITION"). On May 13, 2003, Sheffield Pharmaceuticals, Inc. announced its financial results for the quarter ended March 31, 2003. The full text of the press release issued in connection with the announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K. In accordance with the procedural guidance in SEC Release No. 33-8216, the information in this Current Report on Form 8-K and the Exhibit attached hereto is being furnished under "Item 9. Regulation FD Disclosure" rather than under "Item 12. Disclosure of Results of Operations and Financial Condition." The information shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing. 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. SHEFFIELD PHARMACEUTICALS, INC. May 14, 2003 By: /s/ Thomas M. Fitzgerald ------------------------------------------- Thomas M. Fitzgerald President and Chief Executive Officer INDEX TO EXHIBITS EXHIBIT NUMBER DESCRIPTION -------------- ----------- 99.1 Press Release dated May 13, 2003 EX-99.1 3 l01020aexv99w1.txt EXHIBIT 99.1 EXHIBIT 99.1 [SHEFFIELD LOGO] NEWS RELEASE For further information contact: Thomas M. Fitzgerald, President & CEO Sheffield Pharmaceuticals, Inc. (585) 292-0310 FOR IMMEDIATE RELEASE SHEFFIELD PHARMACEUTICALS, INC. REPORTS RESULTS FOR THE FIRST QUARTER OF 2003 ROCHESTER, NY - MAY 13, 2003 -- Sheffield Pharmaceuticals, Inc. (AMEX:SHM) today announced its financial results for the first quarter of 2003. The Company reported a net loss of $.9 million, or $.05 per share, for the first quarter of 2003 compared to a net loss of $3.1 million, or $.13 per share, for the first quarter of 2002. At March 31, 2003, total assets were $1.2 million, of which $.2 million was cash and cash equivalents. The Company's long-term debt was $10.5 million. The decreased net loss of $2.2 million for the first quarter of 2003 primarily resulted from higher general and administrative ("G&A") expenses in the first quarter of 2002 due to expanded business development activities in the areas of licensing and partnering of the Company's development products, activities related to potential acquisitions of complementary pulmonary delivery technologies and companies, as well as costs associated with the departure of certain executive officers. The lower net loss also reflects lower development expenses related to the Company's unit dose budesonide product, lower Premaire(R) development costs as well as reduced formulation work on the Premaire(R) budesonide product, lower Tempo(TM) development costs resulting from finalizing the industrialization of the device in the first half of 2002 for Phase I and II trials and reduced R&D administrative costs. This is offset by increased interest expense reflecting higher average borrowing levels in 2003 as compared to 2002. As of March 31, 2003, the Company had cash and equivalents of approximately $.2 million and accounts payable and accrued liabilities of $3.1 million. Unless the Company is able to raise significant capital ($1 million to $2.5 million) within the next 60 days, management believes that it is unlikely that the Company will be able to meet its obligations as they become due and to continue as a going concern. To meet this capital requirement, the Company is evaluating various financing alternatives including, but not limited to, private offerings of the Company's securities, other debt financings, collaboration and licensing arrangements with other companies, and the sale of non-strategic assets and/or technologies to third parties. Should the Company be unable to meet its capital requirement through one or more of the above-mentioned financing alternatives, the Company may file for bankruptcy or similar protection under the 1978 Bankruptcy Code and the basis of presentation of the Company's financial statements will be adjusted to reflect a liquidation basis of accounting. Sheffield Pharmaceuticals, Inc. provides innovative, cost-effective pharmaceutical therapies by combining state-of-the-art pulmonary drug delivery technologies with existing and emerging therapeutic agents. Sheffield is developing a range of products to treat respiratory and systemic diseases using pressurized metered dose, solution-based and dry powder inhaler and formulation technologies, including its proprietary Premaire(R) Delivery System and Tempo(TM) Inhaler. Sheffield focuses on improving clinical outcomes with patient-friendly alternatives to inconvenient or sub-optimal methods of drug administration. Investors can learn more about Sheffield Pharmaceuticals on its Web site at www.sheffieldpharm.com. This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are intended to be covered by the safe harbors created thereby. Investors are cautioned that all forward-looking statements, including without limitation, statements containing the words "believes," anticipates," "intends," "plans," "expects" and words of similar import, involve risks and uncertainty. Although the Company believes that the assumptions underlying the forward-looking statements contained herein are reasonable, any of the assumptions could be inaccurate, and therefore, the Company's actual results could differ materially from the results anticipated in the forward-looking statements included in this press release. For a discussion of factors that could cause or contribute to such material differences, investors are directed to the risks and uncertainties contained in the Company's Form 10-Q for the quarter ended March 31, 2003, and other documents filed by the Company with the Securities and Exchange Commission. The risks and uncertainties that could cause actual results to differ materially from the forward-looking statements include the difficulties of a development stage pharmaceutical company raising substantial additional capital (through financings or otherwise) in the current environment to fund its operations and the progress of development, government and regulatory approvals and licensing/commercialization of the Company's technologies. In light of the significant uncertainties inherent in the forward-looking statements included herein, the inclusion of such information should not be regarded as a representation by the Company or any other person that the objectives and plans of the Company will be achieved. ### SHEFFIELD PHARMACEUTICALS, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE THREE MONTHS ENDED MARCH 31, 2003 AND 2002
THREE MONTHS ENDED MARCH 31, 2003 2002 ----------- ----------- (Unaudited) (Unaudited) Revenues: Contract research revenue.................. $ 75,000 $ - Expenses: Research and development................... 250,250 1,153,790 General and administrative................. 398,838 1,938,666 ----------- ----------- Total expenses........................ 649,088 3,092,456 ----------- ----------- Loss from operations............................ (574,088) (3,092,456) Interest income................................. 179 2,662 Interest expense................................ (320,110) (149,831) Minority interest in loss of subsidiary......... 13,156 106,042 ----------- ----------- Net loss........................................ $ (880,863) $(3,133,583) =========== =========== Basic and diluted net loss per share of common stock........................................... $ (0.05) $ (0.13) =========== =========== Basic and diluted weighted average common shares outstanding..................................... 29,563,712 29,024,008 =========== ===========
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BALANCE SHEET HIGHLIGHTS MARCH 31, DECEMBER 31, 2003 2002 (Unaudited) ------------ ------------ Cash and equivalents ..................... $ 162,811 $ 327,195 Current assets ........................... $ 574,114 $ 835,314 Total assets ............................. $ 1,243,984 $ 1,514,658 Current liabilities ...................... $ 5,433,437 $ 5,022,929 Long-term debt ........................... $ 10,500,000 $ 10,500,000 Stockholders' equity (deficit) ........... $(16,243,182) $(15,385,984) Total liabilities and stockholders' equity $ 1,243,984 $ 1,514,658
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