-----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, QsYWdORhJgLTn543qGLGOE6kAnKqgmQ9ZYvVtcm56jci0/I6w+eTG1ppFsxf2fEO Uac4LusX4khilR/bhL+nzA== 0000921895-04-001732.txt : 20041101 0000921895-04-001732.hdr.sgml : 20041101 20041101172846 ACCESSION NUMBER: 0000921895-04-001732 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20041028 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20041101 DATE AS OF CHANGE: 20041101 FILER: COMPANY DATA: COMPANY CONFORMED NAME: QUIGLEY CORP CENTRAL INDEX KEY: 0000868278 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 232577138 STATE OF INCORPORATION: NV FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-21617 FILM NUMBER: 041111019 BUSINESS ADDRESS: STREET 1: KELLS BUILDING STREET 2: 621 SHADY RETREAT RD CITY: DOYLESTOWN STATE: PA ZIP: 18901 BUSINESS PHONE: 2153450919 MAIL ADDRESS: STREET 1: PO BOX 1349 STREET 2: LANDMARK BLDG, 10 S CLINTON ST CITY: DOYLESTOWN STATE: PA ZIP: 18901 8-K 1 form8k03814_10282004.htm sec document
                                  UNITED STATES
                       SECURITIES AND EXCHANGE COMMISSION
                              WASHINGTON, DC 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) OCTOBER 28, 2004
                                                         ----------------

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


                             THE QUIGLEY CORPORATION
               ---------------------------------------------------
               (Exact Name of Registrant as Specified in Charter)


      NEVADA                            0-21617                  23-2577138
      ------                            -------                  ----------
(State or Other Jurisdiction          (Commission            (IRS Employer
  of Incorporation)                    File Number)          Identification No.)


 KELLS BUILDING, 621 SHADY RETREAT ROAD, P.O. BOX 1349, DOYLESTOWN, PA   18901
 -----------------------------------------------------------------------------
  (Address of Principal Executive Office  s)                          (Zip Code)

        Registrant's telephone number, including area code (215) 345-0919
                                                           --------------


                                       N/A
          -------------------------------------------------------------
          (Former Name or Former Address, if Changed Since Last Report)


     Check the  appropriate  box below if the Form 8-K  filing  is  intended  to
simultaneously  satisfy the filing obligation of the registrant under any of the
following provisions (see General Instruction A.2. below):

     |_| Written  communications  pursuant to Rule 425 under the  Securities Act
(17 CFR 230.425)

     |_| Soliciting  material pursuant to Rule 14a-12 under the Exchange Act (17
CFR 240.14a-12)

     |_|  Pre-commencement  communications  pursuant to Rule 14d-2(b)  under the
Exchange Act (17 CFR 240.14d-2(b))

     |_|  Pre-commencement  communications  pursuant to Rule 13e-4(c)  under the
Exchange Act (17 CFR 240.13e-4(c))




ITEM 2.02     RESULTS OF OPERATIONS AND FINANCIAL CONDITION.

     On October 28, 2004, The Quigley Corporation (the "Company")  announced its
results for the quarter  ended  September  30, 2004.  The full text of the press
release is attached hereto as Exhibit 99.1.

     The information  furnished  pursuant to Item 2.02 of this Current Report on
Form 8-K,  including  Exhibit 99.1 hereto,  shall not be considered  "filed" for
purposes of Section 18 of the  Securities  Exchange Act of 1934, as amended,  or
otherwise subject to the liability of such section, nor shall it be incorporated
by reference  into future  filings by the Company  under the  Securities  Act of
1933,  as amended or under the  Securities  Exchange  Act of 1934,  as  amended,
unless  the  Company  expressly  sets  forth in such  future  filing  that  such
information is to be considered "filed" or incorporated by reference therein.

ITEM 8.01     OTHER EVENTS.

     On October  28,  2004,  the Company  provided  updates on the status of its
pharmaceutical  pipeline.  The full text of the press release is attached hereto
as Exhibit 99.1.

ITEM 9.01     FINANCIAL STATEMENTS AND EXHIBITS.

      (c)     Exhibits.

      EXHIBIT NO.     DESCRIPTION

      99.1            Press Release dated July 30, 2004 reporting second quarter
                      preliminary unaudited earnings.





                                   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.



                               THE QUIGLEY CORPORATION
                                      (Registrant)

Date:  November 1, 2004
                               By:    /s/ George J. Longo
                                    -------------------------------
                               Name:  George J. Longo
                               Title: Vice President and Chief Financial Officer



EX-99.1 2 ex991to8k03814_10282004.htm sec document
&

                                                                    Exhibit 99.1


CONTACT:
David K. Waldman/John W. Heilshorn                     Carl Fonash
Lippert Heilshorn & Associates                         The Quigley Corporation
(212) 838-3777                                         (267) 880-1111
DWALDMAN@LHAI.COM

                      QUIGLEY REPORTS THIRD QUARTER RESULTS

        - Company Provides Updates on Status of Pharmaceutical Pipeline -

DOYLESTOWN,  PA. - OCTOBER  28, 2004 - THE QUIGLEY  CORPORATION  (NASDAQ:  QGLY)
today reported net sales of $9.7 million for the third quarter of 2004, compared
to $9.9 million reported for the same period in 2003. For the nine-months  ended
September 30, 2004, net sales were $26.2  million,  compared to $25.1 million in
2003.

Net sales of the  Company's  Cold Remedy  segment  increased  8.3% for the third
quarter  of 2004 as  compared  to 2003.  Net sales of the  Health  and  Wellness
segment  decreased  11.4% during the quarter,  due to a decline in the number of
active domestic  independent  representatives and reductions for summer vacation
activities,  which was  partially  offset by an increase  in  European  sales as
compared to 2003. The increase in net sales for the nine months reflects a 13.2%
increase in the  Company's  Cold Remedy and also reflects  relatively  unchanged
sales of Health  and  Wellness  segment.  The  Company's  Cold  Remedy net sales
increased for the nine months, as a result of continued  strategic  advertising,
marketing initiatives, and new product extensions of Cold-EEZE(R). The Company's
Health and Wellness revenues for the nine months were relatively  unchanged even
as distribution continues to expand internationally.

Net income for the third quarter ended September 30, 2004 was $177,000, or $0.01
per share,  compared to net income of $134,000, or $0.01 per share, for the same
period last year. Net loss for the nine-months ended September 30, 2004 was $1.5
million,  or  ($0.13)  per share,  compared  to a net loss of $1.9  million,  or
($0.16) per share,  for the same period last year.  During the third quarter and
nine-months  ended  September  30,  2004,  the  Company  incurred  research  and
development costs of $627,000 and $2.4 million, respectively.

Net income for the quarter or net loss for the  nine-months  ended September 30,
2004 improved as compared with the same periods last year,  primarily  driven by
gross profit gains and operating  costs savings from the Cold Remedy segment and
increases in other income, which were offset by a charge of $1.4 million related
to the  discontinuation  of the Company's  Cold-EEZE(R)  Cold Remedy Nasal Spray
product. The charge includes a $422,000 write-off of nasal spray inventory and a
$974,000  reduction to net sales resulting from anticipated  customer returns of
the product. At this time, the Company does not anticipate any additional future
effects related to the discontinuation of the Company's Cold-EEZE(R) Cold Remedy
Nasal Spray product.

No tax or tax benefits to reduce  income or losses are provided for the quarters
and nine-months ended September 30, 2004 and 2003, since the Company is in a net
operating loss  carry-forward  position,  which is from the cumulative effect of
deductions attributed to options,  warrants and unrestricted stock from previous
year's taxable income.

Guy J. Quigley,  Chairman,  President and Chief Executive  Officer  stated,  "We
continue  to  increase  market  penetration  of  our  Cold-EEZE(R)  Cold  Remedy
products,  including our new COLD-EEZE(R) bubble gum and COLD-EEZE(R) `green-tea
with lemon' lozenges.  Although the Cold-EEZE(R) Cold Remedy Nasal Spray has not
met our  expectations,  we are quite  pleased with the  performance  of our core
products and are reallocating our resources  accordingly.  Additionally,  within
our Health and Wellness segment, we are adding an exclusive new skincare product
line promoted by a well known  celebrity,  details of which will be announced in
the near future."



Mr. Quigley  continued,  "During the quarter,  several compounds in our pipeline
have shown positive preliminary results. We have also received guidance, through
pre-IND meetings, from the U.S. Food and Drug Administration  regarding the next
steps for permission to further study QR-333 and QR-336."

The Company provides the following updates to its pharmaceutical pipeline:

DIABETIC NEUROPATHY (QR-333)

The FDA has  provided  guidance at a pre-IND  meeting for the  company's  QR-333
compound.  The formulation will be entering into a series of toxicity studies in
order to support the safety of this naturally derived compound for the relief of
symptoms  of  diabetic  peripheral   neuropathy.   Despite  its  composition  of
all-natural  botanical  ingredients,  the FDA views this  compound as a chemical
entity that requires animal model safety data.

RADIATION EXPOSURE (QR-336)

At a recent pre-IND  meeting with the FDA, the company's  pre-clinical  research
plan, to conduct an audited and inspected Good Laboratory  Practice (GLP) animal
study at The  University  for the Uniform  Health  Services in Bethesda  MD, was
reviewed and guidance was provided by the agency.  Previous positive indications
in a preliminary  non-GLP animal study  necessitated  this meeting.  QR-336 is a
naturally  derived  compound  that  indicated in  previously  conducted  non GLP
studies to protect  against a lethal  dose of  ionizing  radiation  in an animal
model.

INFLUENZA (QR-435)

Retroscreen  LTD. at The  University of London will be conducting a final animal
model  influenza  study in  preparation  for a proposed  human  proof-of-concept
study.  The study will  determine if there is any efficacy or safety issues with
different  dose  forms  of  this  naturally  derived  broad-spectrum  anti-viral
compound.

ARTHRITIS (QR-440)

As  previously  announced,  Quigley  Pharma is also moving  forward to establish
clinical  testing for the  treatment of  arthritis  for this  naturally  derived
compound.

The  Quigley  Corporation  makes  no  representation  that  the US Food and Drug
Administration or any other regulatory agency will grant an Investigational  New
Drug ("IND") or take any other action to allow its formulations to be studied or
marketed. Furthermore, no claim is made that potential medicine discussed herein
is  safe,   effective,   or  approved  by  the  Food  and  Drug  Administration.
Additionally,  data that demonstrates activity or effectiveness in animals or in
vitro tests do not necessarily mean the formula test compound, referenced herein
will be effective in humans.  Safety and effectiveness in humans will have to be
demonstrated  by means of adequate and well controlled  clinical  studies before
the clinical  significance of the formula test compound is known. Readers should
carefully  review the risk factors  described in filings the Company  files from
time to time with the Securities and Exchange Commission.

The Quigley Corporation (Nasdaq:  QGLY,  http://www.Quigleyco.com)  is a leading
developer and marketer of diversified health products including the COLD-EEZE(R)
family of patented zinc  gluconate  glycine  (ZIGG(TM))  lozenges and sugar free
tablets. COLD-EEZE is the only (ZIGG) lozenge proven in two double-blind studies
to reduce the  duration  of the common  cold from 7.6 to 4.4 days or by 42%.  In
addition to  Over-The-Counter  (OTC)  products,  the Company has formed  Quigley
Pharma   Inc.   (http://www.QuigleyPharma.com   ),  a   wholly   owned   ethical
pharmaceutical  subsidiary,  to introduce a line of  naturally-derived  patented
prescription drugs. The Quigley Corporation's customers include leading national
wholesalers  and  distributors,  as well as independent and chain food, drug and
mass merchandise stores and pharmacies.



FORWARD-LOOKING STATEMENTS

Certain statements in this press release are "forward-looking statements" within
the meaning of the Private Securities  Litigation Reform Act of 1995 and involve
known and  unknown  risk,  uncertainties  and other  factors  that may cause the
Company's actual performance or achievements to be materially different from the
results, performance or achievements expressed or implied by the forward-looking
statement.  Factors that impact such forward-looking  statements include,  among
others,  changes in worldwide general economic  conditions,  changes in interest
rates, government regulations, and worldwide competition.





                                 (Tables Follow)










CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)

The following represents condensed financial data (in thousands) except per share data:

                                               Three-Months          Three-Months          Nine Months           Nine Months
                                                  Ended                 Ended                 Ended                 Ended
                                            September 30, 2004    September 30, 2003    September 30, 2004    September 30, 2003
                                                   ($)                   ($)                   ($)                   ($)
                                            ------------------    ------------------    ------------------    ------------------
Net Sales                                         9,691                 9,912                 26,198                25,108
Gross profit                                      3,800                 4,488                 11,097                10,948
Sales & marketing expenses                          915                 1,096                  3,373                 3,439
Administrative expenses                           2,314                 2,047                  7,119                 6,801
Research & development                              627                 1,230                  2,395                 2,599

Income taxes (Benefit)                               --                    --                     --                    --
Income (loss) from:
   Continuing operations                            177                   134                 (1,517)               (1,813)
   Discontinued operations                           --                    --                     --                   (55)

Net income (loss)                                   177                   134                 (1,517)               (1,868)

Diluted income (loss) per share:
   Continuing operations                          $0.01                 $0.01                 ($0.13)               ($0.16)
   Discontinued operations                           --                    --                     --                    --

Net income (loss)                                 $0.01                 $0.01                 ($0.13)               ($0.16)

Diluted weighted average common
 shares outstanding:                         14,119,535            14,397,286             11,511,858            11,464,105


CONSOLIDATED BALANCE SHEETS (UNAUDITED)
- ---------------------------------------

The following represents condensed financial data (in thousands) September 30, 2004 and December 31, 2003:

                                                                        2004                    2003

                                                                        ($)                     ($)
                                                                       ------                  ------
              Cash & cash equivalents                                  11,703                  11,392
              Accounts receivable, net                                  3,968                   7,862
              Inventory                                                 4,270                   3,753
              Total current assets                                     20,556                  23,740
              Total assets                                             22,842                  26,270
              Total current liabilities                                 3,759                   5,483
              Total stockholders' equity                               19,024                  20,787



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