-----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, CgUZBls1KapSKMTPQYbjkl0W1ZU5BfsRvsK0ENgkrAHa3tVJsklHDu/sGwSGAbmD Buz23vYAIZitpO2i3opwIQ== 0000950005-03-000809.txt : 20030813 0000950005-03-000809.hdr.sgml : 20030813 20030813162248 ACCESSION NUMBER: 0000950005-03-000809 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20030812 ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20030813 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CELLEGY PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000887247 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 820429727 STATE OF INCORPORATION: CA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-26372 FILM NUMBER: 03841561 BUSINESS ADDRESS: STREET 1: 349 OYSTER POINT BLVD. STREET 2: SUITE 200 CITY: SO. SAN FRANCISCO STATE: CA ZIP: 94080 BUSINESS PHONE: 6506262200 MAIL ADDRESS: STREET 1: 349 OYSTER POINT BLVD. STREET 2: SUITE 200 CITY: SO. SAN FRANCISCO STATE: CA ZIP: 94080 8-K 1 p17550_8-k.txt CURRENT REPORT 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): August 12, 2003 CELLEGY PHARMACEUTICALS, INC. - -------------------------------------------------------------------------------- (Exact Name of Registrant as Specified in Its Charter) California ------------------------------- (State or Other Jurisdiction of Incorporation) 0-26372 820429727 ------- --------- (Commission File Number) (IRS Employer Identification No.) 349 Oyster Point Boulevard, Suite 200 South San Francisco, CA 94080 (Address of Principal Executive Offices) (Zip Code) (650) 616-2000 - -------------------------------------------------------------------------------- (The Registrant's Telephone Number, Including Area Code) Not Applicable - -------------------------------------------------------------------------------- (Former Name or Former Address, if Changed Since Last Report) Item 7. Financial Statements, Pro Forma Financial Information and Exhibits. (c) Exhibits. 99.1 Press Release, dated August 12, reporting the results of operations of Cellegy Pharmaceuticals, Inc. (the "Registrant") for its second fiscal quarter and the six months ended June 30, 2003 (furnished and not filed herewith solely pursuant to Item 12). Item 12. Results of Operations and Financial Condition On August 12, 2003, the Registrant reported its results of operations for its fiscal second quarter and six months ended June 30, 2003. A copy of the press release issued by the Registrant concerning the foregoing results is furnished herewith as Exhibit 99.1 and is incorporated herein by reference. The information contained herein and in the accompanying exhibit shall not be incorporated by reference into any filing of the Registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing, unless expressly incorporated by specific reference to such filing. The information in this report, including the exhibit hereto, shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. 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. CELLEGY PHARMACEUTICALS, INC. Dated: August 12, 2003 By: /s/ A. Richard Juelis --------------------- Name: A. Richard Juelis Title: Vice President, Finance and Chief Financial Officer EXHIBIT INDEX Exhibit Number Description of Document - ------ ----------------------- 99.1 Press Release of Registrant, dated August 12, 2003, reporting the results of operations for the Registrant's fiscal second quarter and six months ended June 30, 2003. EX-99.1 3 p17550_ex99-1.txt PRESS RELEASE EXHIBIT 99.1 Cellegy Pharmaceuticals Reports Second Quarter Financial Results - Conference Call Scheduled for Thursday, August 14th at 9:30 a.m. PDT - South San Francisco, California - August 12, 2003 - Cellegy Pharmaceuticals, Inc. (Nasdaq: CLGY) reported today that for the second quarter ended June 30, 2003, revenues were $263,000, compared with $150,000 for the same period last year. Revenues during this year's second quarter consisted of $55,000 of Rectogesic(TM) (nitroglycerin ointment) product sales in Australia and $208,000 in licensing revenue from PDI, Inc., Cellegy's licensee for Fortigel(TM) (testosterone gel) 2%. Revenues for last year's second quarter were comprised of $95,000 in Australian Rectogesic sales and $55,000 in skin care product sales to Gryphon Development, the product development division of a major specialty retailer. For the six months ended June 30, 2003, revenues were $655,000 comprised of $171,000 (a 30% plus increase over last year's first half) in Rectogesic sales in Australia, $416,000 in licensing revenue from PDI, $55,000 in skin care product sales and $13,000 in Canadian government grants. Revenues for the first six months of last year were $417,000 consisting of $131,000 in Rectogesic sales in Australia and $286,000 in skin care product sales, primarily to Gryphon. For the three months ended June 30, 2003, the Company had a net loss of $4,582,000 or $0.23 per share, compared with a net loss of $5,624,000 or $0.32 per share for the same period last year. For the six months ended June 30, 2003, the net loss was $7,714,000 or $0.39 per share, compared with a net loss of $10,010,000 or $0.58 per share for the same period last year. Cash and investments at June 30, 2003 were $17.6 million, compared with $ 20.9 million at March 31, 2003 and $23.9 million at December 31, 2002. Net cash used in operations during the second half of this year is expected to average about $1.0 million per month. Commenting on the first half results, K. Michael Forrest, Chairman and CEO, said, "We are making good progress with patient enrollment in our Cellegesic and Tostrelle clinical trials and with our nitric oxide donor-based development programs. Management changes in our clinical department are contributing to the expeditious completion of these key clinical studies. We will continue to control spending and preserve cash, focusing on our core product development projects." A Conference Call, to discuss second quarter financial results and provide a business update, will be held on Thursday, August 14, 2003 beginning at 12:30 pm EDT (9:30 am PDT). Please dial (888) 803-8269 from the United States. Those interested in listening to the conference call live via the Internet may do so by visiting the Company's Web site at www.cellegy.com. To listen to -more- the call live, please go to the Web site 15 minutes prior to its start to register; a replay will be available on the Web site for 14 days. Additional Financial Information In December 2002, Cellegy received $15 million from PDI for exclusive commercial rights to Fortigel in North American markets. To date, Cellegy has recorded licensing revenue of $208,000 from PDI in each of the first two quarters of 2003 reflecting the amortization of this payment over the expected commercial life of Fortigel. The balance will continue to be recorded as licensing revenue in subsequent quarters over the life of the product. Gryphon has not yet determined their skin care product requirements for the remainder of 2003. Lower operating expenses in the first two quarters of this year, compared with the same period last year resulted primarily from pre-launch marketing costs for the Company's CellegesicTM (nitroglycerin ointment) 0.4% product candidate last year, as well as, the costs of completing two Phase III clinical trials last year. No additional Cellegesic marketing costs are anticipated for 2003. Operating expenses in this year's second quarter included non-cash compensation charges, totaling approximately $935,000, associated with the cancellation of certain Cellegy stock options, a payment made in stock to acquire certain patent rights and bonus payments made in stock. Clinical expenses are expected to increase during the next two quarters as enrollment in the Cellegesic and Tostrelle clinical trials accelerate. In the first quarter ended March 31, 2003, Cellegy incurred a non-cash, non-operating expense of $542,000 associated with the reassessment of Cellegy's South San Francisco facility sub-lease arrangement, primarily related to the write down of capitalized tenant improvements. We do not expect any further adjustments to these assets in the foreseeable future. About Cellegy Cellegy Pharmaceuticals is a specialty biopharmaceutical company engaged in the development and commercialization of prescription drugs with primary focus in the areas of gastroenterology, sexual dysfunction and nitric oxide donor technologies. The Company is currently in discussions with the FDA to determine their requirements for marketing approval of Fortigel for the treatment of male hypogonadism. Cellegy recently reported clinical progress in its Phase 3 study using Cellegesic for treatment of chronic anal fissure pain and announced positive, interim Phase 2 study results using Tostrelle gel, for the treatment of female sexual dysfunction. Tostrelle is undergoing an amended Phase 2 clinical trial in the United States. In addition, Cellegy has developed expertise in the use of nitroglycerin ointment and nitric oxide donors to address a number of serious medical conditions. Other nitroglycerin based product candidates, in earlier development, are targeting treatment of female sexual dysfunction, Raynaud's disease, prostate cancer and breast cancer. -more This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Securities Litigation Reform Act of 1995, which reflect management's intentions, hopes, beliefs, expectations or predictions for the future. Investors are cautioned that these forward-looking statements are subject to numerous risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. Such risks and uncertainties relate to, among other factors: the completion and outcome of clinical trials; the outcome and timing of discussions with the FDA, particularly with regard to additional requirements for marketing approval of Fortigel; and our need and ability to complete corporate partnerships and further finance the Company. There can be no assurance that we will have sufficient resources to conduct an additional Phase 3 Fortigel trial, if required by the FDA, that any of Cellegy's products will be approved for marketing by regulatory authorities or that these product candidates would be successfully marketed following approval. We undertake no obligation to update or revise the statements made herein. For more information regarding the above, and other risk factors that may affect Cellegy's future results, investors should refer to the Company's Annual Report on Form 10-K for the year ended December 31, 2002. Cellegy Pharmaceuticals: Richard Juelis K. Michael Forrest Vice President, Finance & CFO Chairman, President and CEO Phone: (650) 616-2200 www.cellegy.com Lippert/Heilshorn & Associates: Bruce Voss (bvoss@lhai.com) Ina McGuinness (imcguinness@lhai.com) (310) 691-7100 www.lhai.com - more- Cellegy Pharmaceuticals, Inc. Summary Financial Results June 30, 2003 CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS (Unaudited) (Amounts in thousands, except per share amounts) - --------------------------------------------------------------------------------
Three Months Ended Six Months Ended June 30, June 30, -------- -------- 2003 2002 2003 2002 -------- -------- -------- -------- Revenues $ 263 $ 150 $ 655 $ 417 Costs and expenses: Cost of product sales 6 15 40 86 Research and development 3,314 3,651 5,175 6,613 Selling, general and administrative 1,712 2,237 2,845 4,113 -------- -------- -------- -------- Total costs and expenses 5,032 5,903 8,060 10,812 Operating loss (4,769) (5,753) (7,405) (10,395) Interest income (expense) and other income (expense), net 187 129 (309) 385 -------- -------- -------- -------- Net loss $ (4,582) $ (5,624) $ (7,714) $(10,010) ======== ======== ======== ======== Basic and diluted net loss per share $ (0.23) $ (0.32) $ (0.39) $ (0.58) ======== ======== ======== ======== Weighted average shares outstanding 19,951 17,313 19,901 17,304
- more - Cellegy Pharmaceuticals, Inc. Summary Financial Results June 30, 2003 CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Amounts in thousands) - -------------------------------------------------------------------------------- June 30, 2003 December 31, 2002 ------------- ----------------- Cash and investments (1) $ 17,565 $ 23,858 Other assets 3,625 4,521 -------- -------- Total assets $ 21,190 $ 28,379 ======== ======== Current liabilities $ 2,423 $ 2,128 Long-term liabilities (2) 14,469 15,717 Shareholders' equity 4,298 10,534 -------- -------- Total liabilities and shareholders' equity $ 21,190 $ 28,379 ======== ======== (1) Includes restricted cash of $227,000. (2) Includes deferred revenue of $13,751,000 from PDI's upfront license payment. - ### - -----END PRIVACY-ENHANCED MESSAGE-----