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<SEC-DOCUMENT>0000950152-03-005465.txt : 20030514
<SEC-HEADER>0000950152-03-005465.hdr.sgml : 20030514
<ACCEPTANCE-DATETIME>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
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>l01020ae8vk.txt
<DESCRIPTION>SHEFFIELD PHARMACEUTICALS                8-K
<TEXT>
<PAGE>

                                  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)


<TABLE>
<S>                                                             <C>
                    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)
</TABLE>


                                 (585) 292-0310
                (Company's telephone number, including area code)


                                (NOT APPLICABLE)
          (Former name or former address, if changed since last report)



<PAGE>




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.



<PAGE>




                                   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




<PAGE>


                                INDEX TO EXHIBITS


  EXHIBIT NUMBER           DESCRIPTION
  --------------           -----------

       99.1                Press Release dated May 13, 2003






</TEXT>
</DOCUMENT>
<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>3
<FILENAME>l01020aexv99w1.txt
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
<PAGE>


                                                                    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.



<PAGE>


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.

                                       ###


<PAGE>





                SHEFFIELD PHARMACEUTICALS, INC. AND SUBSIDIARIES
                      CONSOLIDATED STATEMENTS OF OPERATIONS
               FOR THE THREE MONTHS ENDED MARCH 31, 2003 AND 2002

<TABLE>
<CAPTION>
                                                                   THREE MONTHS ENDED
                                                                        MARCH 31,
                                                                2003                 2002
                                                            -----------           -----------
                                                            (Unaudited)           (Unaudited)

<S>                                                         <C>                 <C>
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
                                                            ===========           ===========

</TABLE>

- --------------------------------------------------------------------------------

<TABLE>
<CAPTION>
BALANCE SHEET HIGHLIGHTS                              MARCH 31,            DECEMBER 31,
                                                        2003                   2002
                                                     (Unaudited)
                                                    ------------           ------------

<S>                                                 <C>                    <C>
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
</TABLE>



</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
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