-----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, Md3eVEPoclOD9JRRt48g+vRbULpDwv73AwHg9oJUGFvX/uY/1ruRZ66Q7HJkp843 S3OmXozrUyU4WuUf/plZGw== 0001021408-02-009959.txt : 20020730 0001021408-02-009959.hdr.sgml : 20020730 20020730142355 ACCESSION NUMBER: 0001021408-02-009959 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20020730 ITEM INFORMATION: Financial statements and exhibits ITEM INFORMATION: FILED AS OF DATE: 20020730 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SALIX PHARMACEUTICALS LTD CENTRAL INDEX KEY: 0001009356 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 943267443 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-23265 FILM NUMBER: 02714547 BUSINESS ADDRESS: STREET 1: 8540 COLONNADE CENTER DR STREET 2: SUITE 501 CITY: RALEIGH STATE: NC ZIP: 27615 BUSINESS PHONE: 9198621000 MAIL ADDRESS: STREET 1: 8540 COLONNADE CENTER DR STREET 2: SUITE 501 CITY: RALEIGH STATE: NC ZIP: 27615 FORMER COMPANY: FORMER CONFORMED NAME: SALIX HOLDINGS LTD DATE OF NAME CHANGE: 19970807 8-K 1 d8k.txt FORM 8-K 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) July 30, 2002 SALIX PHARMACEUTICALS, LTD. --------------------------------------------------------- (Exact name of registrant as specified in its charter) Delaware - -------------------------------------------------------------------------------- (State or other jurisdiction of incorporation) 000-23265 94-3267443 - -------------------------------------- ---------------------------------- (Commission file Number) (IRS Employer ID Number) 8540 Colonnade Center Drive, Suite 501, Raleigh, North Carolina 27615 - -------------------------------------------------------------------------------- (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code (919) 862-1000 ------------------------------ Item 7. Financial Statements and Exhibits (c) Exhibits 99.1 Press Release dated July 30, 2002 Item 9. Regulation FD Disclosure On July 30, 2002, Salix announced its operating results for the quarter ended June 30, 2002. 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. SALIX PHARMACEUTICALS, LTD. Date: July 30, 2002 By: /s/ Adam C. Derbyshire ------------------------------------------ Adam C. Derbyshire Vice President and Chief Financial Officer EX-99.1 3 dex991.txt PRESS RELEASE DATED JULY 30, 2002 Exhibit 99.1 FOR IMMEDIATE RELEASE Contact: Adam C. Derbyshire Mike Freeman Vice President and Director, Investor Relations and Chief Financial Officer Corporate Communications 919-862-1000 919-862-1000 SALIX PHARMACEUTICALS REPORTS SECOND QUARTER 2002 FINANCIAL RESULTS RALEIGH, NC, July 30, 2002 - Salix Pharmaceuticals, Ltd. (Nasdaq:SLXP) today announced operating results for the second quarter of 2002. The Company reported a net loss of $5.2 million, or $0.24 per share, for the second quarter of 2002. Product revenues for the period were $7.3 million, an increase of 74%, compared to $4.2 million for the prior year period. Product revenues for the first six months of 2002 were $13.5 million, an increase of 80%, compared to $7.5 million for the first six months of 2001. Product revenues were derived from sales of COLAZAL(R) (balsalazide disodium) Capsules 750 mg, the Company's first-line therapy for the treatment of mildly to moderately active ulcerative colitis. Cost of sales was $1.8 million for the second quarter and $3.4 million for the first six months of 2002. Gross margin was 75.5% and 75.2%, respectively, for the same periods. Operating expenses were $12.8 million for the second quarter of 2002, compared to $8.9 million for the prior year period. Operating expenses were $23.9 million for the first six months of 2002, compared to $17.4 million for the prior year period. Selling, general and administrative expenses were $7.5 million and $14.4 million for the second quarter and first six months of 2002, respectively, compared to $5.6 million and $11.2 million for the same respective periods of 2001. Research and development expenses were $3.5 million for the second quarter of 2002, compared to $1.5 million for the prior year period. Research and development expenses were $6.0 million for the first six months of 2002, compared to $2.9 million for the first six months of 2001. Cash, cash equivalents and investments were $69.4 million on June 30, 2002. Commenting on the quarter, Carolyn Logan, President and Chief Executive Officer, stated, "COLAZAL continues to be a great product for us. Approximately 44,000 prescriptions were written during the second quarter of 2002, compared to 34,200 prescriptions during the first quarter of 2002. This represents a 29% quarter-over-quarter rate of growth. The 44,000 prescriptions written during the quarter represent a 280% year-over-year increase compared to the 11,600 prescriptions written during the second quarter of 2001. Based upon information currently available, we continue to estimate that net COLAZAL sales for 2002 will be between $30 and $35 million. "We believe that today Salix is in its strongest position ever to accomplish its mission to become the leading specialty gastroenterology company in the United States. We are executing our strategy. Our 60-member specialty sales force is building relationships with gastroenterologists, our in-house product development team is working to expand the commercial possibilities for rifaximin, and, as announced earlier this month, we have in-licensed rights to an additional product and have established a collaboration with Dr. Falk Pharma GmbH. The mesalamine pellet product we have in-licensed illustrates our commitment to providing gastroenterologists and their patients with product innovations for the treatment of gastrointestinal disease. Feedback from gastroenterologists indicates that no single anti-inflammatory agent provides optimal therapy for all patients, and consequently, the more treatment options available, the better. We have listened to our customers and intend to develop this late-stage product to compliment COLAZAL as another option a gastroenterologist can use to tailor therapy to meet the specific needs of an individual patient. Our collaboration with Dr. Falk Pharma represents a key strategic alignment of one of the leading gastroenterology companies in Europe with Salix. Under the terms of our agreement, we now have access to one of the most highly respected and productive gastroenterology-focused research and development organizations in the world. We are intent on expanding our business and look forward to the future with great anticipation." Adam Derbyshire, Vice President, Finance and Administration, and Chief Financial Officer, stated, "The in-licensing of rights to the pellet formulation of mesalamine is the first of what we intend to be a number of acquisitions as we work to build the Company's product pipeline. We expect research and development expenses for the second half of the year will include the upfront payment for the new mesalamine product and activities in preparation of a Phase III study that we anticipate initiating during the first quarter of 2003. Other R&D expenses for the first six months and anticipated for the remainder of the year include costs associated with several small, single-center studies of rifaximin currently, or soon to be, underway. Based upon information currently available, we estimate that net loss for 2002 will be between $1.15 and $1.35 per share." The Company will host a conference call at 10:00 a.m. EDT, on July 30, 2002 to discuss the subjects of this press release. Interested parties may access the conference call by way of web cast or telephone. The live web cast will be available at http://www.salix.com. The web cast will be archived on the Company's web site through August 5. The telephone numbers to access the conference call are (800) 231-9012 (U.S. and Canada) or (719) 457-2617 (international.) A replay of the call will be available from 1:00 p.m., EDT, July 30 through August 5. The telephone numbers to access the replay of the call are (888) 203-1112 (U.S. and Canada) or (719) 457-0820 (international.) The access code for the replay is 310572. Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription pharmaceutical products for the treatment of gastrointestinal diseases. Salix's strategy is to in-license late-stage or marketed proprietary therapeutic drugs, complete the required development and regulatory submission of these products, and market them through the Company's 60-member gastroenterology specialty sales force. Salix's first marketed product is COLAZAL(R), an anti-inflammatory drug approved for the treatment of mildly to moderately active ulcerative colitis. The Company launched the product in the U.S. through its specialty sales force in January 2001. COLAZAL was well tolerated in clinical studies. In clinical trials, patients reported the following adverse events most frequently: headache (8%); abdominal pain (6%); diarrhea (5%); nausea (5%); vomiting (4%); respiratory infection (4%); and arthralgia (4%). Withdrawal from therapy due to adverse events was comparable to placebo. Salix's next product candidate is rifaximin, currently in development for the potential treatment of infections of the gastrointestinal tract. The Company submitted an NDA for rifaximin for the treatment of travelers' diarrhea to the FDA on December 26, 2001. In July 2002, Salix acquired exclusive U.S. development and marketing rights to a pellet formulation of mesalamine. The Company intends to complete the development work required to secure regulatory approval for the product in the U.S. Salix trades on the Nasdaq National Market under the ticker symbol "SLXP." For more information please contact the Company at 919-862-1000 or visit our web site at www.salix.com. Table follows Salix Pharmaceuticals, Ltd. Condened Consolidated Statement of Operations Unaudited (In thousands, except per share data)
Three Months Ended Six Months Ended June 30, June 30, June 30, June 30, 2002 2001 2002 2001 (unaudited) (unaudited) (unaudited) (unaudited) ------------------------------ ----------------------------- Revenues: Product revenue $ 7,337 $ 4,163 $ 13,548 $ 7,453 Revenue from collaborative agreements - 1,376 - 2,751 ------------------------------ ----------------------------- Total revenues 7,337 5,539 13,548 10,204 Operating Expenses: Cost of products sold 1,797 1,080 3,363 1,866 License fees and costs related to collaborative agreements 31 808 63 1,500 Research and development 3,532 1,456 6,016 2,891 Selling, general and administrative 7,458 5,604 14,436 11,162 ------------------------------ ----------------------------- Total costs and expenses 12,818 8,948 23,878 17,419 Loss from operations (5,481) (3,409) (10,330) (7,215) Interest and other income/(expense), net 267 100 392 9 Income tax - - - - ------------------------------ ----------------------------- Net loss $ (5,214) $ (3,309) $ (9,938) $ (7,206) Net loss per share $ (0.24) $ (0.22) $ (0.51) $ (0.51) ============================== ============================= Weighted average shares outstanding 21,334 14,766 19,624 14,242 ============================== =============================
Salix Pharmaceuticals, Ltd. Condensed Consolidated Balance Sheets (In thousands)
June 30, December 31, 2002 2001 (unaudited) (audited) ---------------------------- Assets Cash, cash equivalents and investments $ 69,367 $ 27,868 Accounts receivable 4,317 2,378 Inventory 9,511 6,274 Other assets 2,201 2,070 ---------------------------- Total Assets $ 85,396 $ 38,590 ============================ Liabilities & Stockholders' Equity Accounts payable and other current liabilities $ 7,179 $ 8,094 Deferred revenue 3,066 2,902 ---------------------------- Total current liabilities 10,245 10,996 Common stock 21 17 Additional paid-in-capital 131,115 73,461 Accumulated deficit (55,821) (45,884) Other comprehensive loss (164) - ---------------------------- Total Stockholders' Equity 75,151 27,594 ---------------------------- Total Liabilities & Equity $ 85,396 $ 38,590 ============================
Please Note: This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include risks of regulatory review and clinical trials, the need to acquire additional products and management of rapid growth. The reader is referred to the documents that the Company files from time to time with the Securities and Exchange Commission. -----END PRIVACY-ENHANCED MESSAGE-----