-----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, GAKWHKJjKWs9GqpoAhAS5niAtu06Gnn38dwoHy+/d/KsA8DjLp37O64RiI5FGmuz 4mJ228S9wbi38QiVbh2TpA== 0000950123-05-007615.txt : 20050622 0000950123-05-007615.hdr.sgml : 20050622 20050622171247 ACCESSION NUMBER: 0000950123-05-007615 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20050622 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050622 DATE AS OF CHANGE: 20050622 FILER: COMPANY DATA: COMPANY CONFORMED NAME: DUSA PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000879993 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 223103129 STATE OF INCORPORATION: NJ FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-31533 FILM NUMBER: 05910747 BUSINESS ADDRESS: STREET 1: 25 UPTON DRIVE CITY: WILMINGTON STATE: MA ZIP: 01887 BUSINESS PHONE: 9786577500 MAIL ADDRESS: STREET 1: 25 UPTON DRIVE CITY: WILMINGTON STATE: MA ZIP: 01887 FORMER COMPANY: FORMER CONFORMED NAME: DEPRENYL USA INC / NJ DATE OF NAME CHANGE: 19930328 8-K 1 y10249e8vk.htm DUSA PHARMACEUTICALS, INC. DUSA PHARMACEUTICALS, INC.
 

 
 

FORM 8-K

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

CURRENT REPORT

Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): June 22, 2005

DUSA PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)
         
New Jersey   0-19777   22-3103129
(State or other
jurisdiction of
incorporation)
  (Commission
File Number)
  (IRS Employer
Identification
Number)

25 Upton Drive
Wilmington, Massachusetts 01887

(Address of principal executive offices, including ZIP code)

(978) 657-7500
(Registrant’s telephone number, including area code)

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):

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

o Soliciting material pursuant to Rule 14a-12 under the Securities Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14a-12(b))

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

 
 

 


 

Item 8.01. Other Events.

In response to current market conditions, DUSA Pharmaceuticals, Inc. issued a press release today attached hereto as Exhibit 99 to update anticipated sales for the quarter ending June 30, 2005 and to clarify the status of negotiations with PhotoCure and Galderma and of its Phase II clinical studies for the treatment of acne.

Except for historical information, this report and news release contain certain forward-looking statements that involve known and unknown risks and uncertainties, which may cause actual results to differ materially from any future results, performance or achievements expressed or implied by the statements made. These forward-looking statements relate to expectations for lower sales for the June 30, 2005 quarter, beliefs regarding physicians’ supplies of Kerastick units, belief regarding effect of BLU-U pricing, timing of results of its Phase II acne clinical trials and intention and timing of release of sales results for the period ending June 30, 2005. Such risks and uncertainties include the Company’s ability to continue to penetrate the market, uncertainties in the clinical trial process, maintenance of its patent portfolio, and other risks identified in DUSA’s SEC filings from time to time, including those contained in DUSA’s Form 10-K for the year ended December 31, 2004.

Item 9.01.Financial Statements and Exhibits.

     
[99]
  Press Release dated June 22, 2005.

 


 

SIGNATURES

     Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

         
    DUSA PHARMACEUTICALS, INC.
 
       
Dated: June 22, 2005
  By:   /s/ D. Geoffrey Shulman
 
       
 
      D. Geoffrey Shulman, MD, FRCPC
 
      Chairman of the Board and Chief Executive Officer

 


 

EXHIBIT INDEX

     
No.   Description
 
   
99
  Press Release dated June 22, 2005

 

EX-99 2 y10249exv99.htm EX-99: PRESS RELEASE EXHIBIT 99
 

Exhibit 99

(DUSA LOGO)
INNOVATION IN PHOTODYNAMIC THERAPY

DUSA Pharmaceuticals, Inc.®
For Immediate Release

DUSA PROVIDES INVESTOR UPDATE

Wilmington, MA. June 22, 2005 - In response to current market conditions, DUSA Pharmaceuticals (NASDAQ NMS: DUSA) reports that it now expects sales of its Levulan® Kerastick® and BLU-U® brand light device for the quarter ending June 30, 2005 to be lower than sales for the quarter ended March 31, 2005. However, management also expects year to date revenue versus the prior year to reflect significant growth. As previously stated in its Form 10-Q for the period ended March 31, 2005, while DUSA is seeing certain positive trends, it believes that the lower volumes of Kerastick units may be due, in part, to the continuing effects of supply levels at physician’s offices who participated in volume discount purchases during late 2004 and who are working down their supplies; and also due to disruption caused by the sales force reorganization which took place during the first and second quarters. In the case of BLU-U sales, DUSA has eliminated price discounting during the second quarter which it believes has had a negative effect on this quarter’s sales.

DUSA also wishes to clarify that while negotiations with PhotoCure and Galderma are on-going and progress is being made, there is no certainty if, or when, a settlement will be reached regarding the parties’ patent dispute. Finally, DUSA wishes to note that its Phase II clinical studies for the treatment of acne remain blinded and that preliminary results are expected to be available by the end of the year, though through the first cohort of the trial, investigators are reporting encouraging results.

In light of recent volatility, DUSA will release its sales results for the June 30, 2005 quarter during mid-July, prior to the full financial results which will be released on or before August 9, 2005.

DUSA Pharmaceuticals, Inc. is a biopharmaceutical company engaged primarily in the development and marketing of Levulan Photodynamic Therapy (PDT) and Photodetection (PD) for multiple medical conditions, with a primary focus on dermatology. PDT and PD utilize light-activated compounds to induce a therapeutic or detection effect. DUSA maintains offices in Wilmington, MA, Valhalla, NY and Toronto, Ontario.

Except for historical information, this news release contains certain forward-looking statements that involve known and unknown risks and uncertainties, which may cause actual results to differ materially from any future results, performance or achievements expressed or implied by the statements made. These forward-looking statements relate to expectations for lower sales for the June 30, 2005 quarter, beliefs regarding physicians’ supplies of Kerastick units, belief regarding effect of BLU-U pricing, timing of results of its Phase II acne clinical trials and intention and timing of release of sales results for the period ending June 30, 2005. Such risks and uncertainties include the Company’s ability to continue to penetrate the market, uncertainties in the clinical trial process, maintenance of its patent portfolio, and other risks identified in DUSA’s SEC

 


 

filings from time to time, including those contained in DUSA’s Form 10-K for the year ended December 31, 2004.

For further information contact:
D. Geoffrey Shulman, MD, Chairman and CEO
or Shari Lovell, Director, Shareholder Services
Tel: 416.363.5059 Fax: 416.363.6602 or visit www.dusapharma.com

 

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