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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 13, 2000
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COMMISSION FILE NUMBER 1-12584
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DELAWARE SHEFFIELD PHARMACEUTICALS, INC. 13-3808303
(State of other jurisdiction of (Exact name of registrant as (I.R.S. Employer
incorporation or organization) specified in its charter) Identification No.)
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425 South Woodsmill Road, St. Louis, Missouri 63017
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(Address of principal executive officers) (Zip Code)
Registrant's telephone number, including area code (314) 579-9899
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Not Applicable
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(Former name or former address, if changed since last report)
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ITEM 9. REGULATION FD DISCLOSURE
Sheffield Pharmaceuticals, Inc. (the "Company") is furnishing under Item 9
of this Current Report on Form 8-K the information included as Exhibit 99.1 to
this report. Exhibit 99.1 includes information that the Company will include in
presentations to current and prospective stockholders and other persons and
institutions who may be interested in the Company and its business, finances or
securities in various forums, including presentations at industry conferences
and one-on-one group meetings with investors or other interested parties.
Exhibit 99.1 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
safe harbors created thereby. Investors are cautioned that all forward-looking
statements 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, there can
be no assurance that the forward-looking statements included in Exhibit 99.1
will prove to be accurate. The Company's future results are subject to risks
and uncertainties including, but not limited to, the risks that (1) the Company
may not be able to obtain additional financing on acceptable terms, or at all,
to continue to fund its operations, (2) the Company's product opportunities may
not be successfully developed, proven to be safe and efficacious in clinical
trials, may not meet applicable regulatory standards, may not receive the
required regulatory approvals, or may not be produced in commercial quantities
at reasonable costs or be successfully commercialized and marketed; (3) the
Company may default in payments required under certain licensing agreements,
thereby potentially forfeiting its rights under those agreements; (4) the
Company may not develop or receive sublicenses or other rights related to
proprietary technology that are patentable, one or more of the Company's pending
patents may not issue, or that any issued patents may not provide the Company
with any competitive advantages, or that the patents may be challenged by third
parties; (5) the Company may not have the resources available to build or
otherwise acquire its own marketing capabilities, or that agreements with other
pharmaceutical companies to market the Company's products may not be reached on
terms acceptable to the Company; (6) manufacturing and supply agreements entered
into by the Company will not be adequate or that the Company will not be able to
enter into future manufacturing and supply agreements on acceptable terms; (7)
private health insurance and government health program reimbursement price
levels may not be sufficient to provide a return to the Company on its
investment in new products and technologies; (8) the failure to meet the
American Stock Exchange's ("AMEX") listing guidelines may result in the Common
Stock of the Company no longer being eligible for listing on the AMEX.
Additional factors include the risk factors set forth in the Company's 1999
Annual Report on Form 10-K. Exhibit 99.1 is dated as of the date hereof and
reflects management's views as of those dates. The Company undertakes no
obligation to update the information contained in Exhibit 99.1, including
forward-looking statements, to reflect subsequently occurring events or
circumstances.
Note: The information in this report (including Exhibit 99.1) is furnished
pursuant to Item 9 and shall not be deemed to be "filed" for the purposes of
Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise
subject to the liabilities of that section. This report will not be deemed an
admission as to the materiality of any information in the report that is
required to be disclosed solely by Regulation FD.
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS
(c) Exhibits
Exhibit Number Description
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99.1 Presentation Information
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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.
Dated: November 13, 2000 By: /s/ Loren Peterson
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Loren Peterson
President and Chief Executive Officer
