Salix Pharmaceuticals Reports 2Q2006 Results.RALEIGH, NC -- Salix Pharmaceuticals, Ltd. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :SLXP): --$52.9 Million Total Product Revenue - 51% y-o-y Increase --XIFAXAN(R) Achieves 29% Quarterly Sequential Prescription Growth --GAAP Income of $6.9 Million : Non-GAAP Income of $7.8 Million --GAAP EPS (Encapsulated PostScript) A PostScript file format used to transfer a graphic image between applications and platforms. EPS files contain PostScript code as well as an optional preview image in TIFF, WMF, PICT or EPSI, the latter being an ASCII-only format. of $0.14 : Non-GAAP EPS of $0.16 --XIFAXAN(R) Patent Coverage Extended to 2024 --FDA Grants Marketing Approval for MOVIPREP(R) --COLAZAL(R) and XIFAXAN(R) Wholesaler Inventories Reduced --Continuing Success in Execution of Strategy to Broaden and Diversify Revenue Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced financial and operating results for the quarter ended June 30, 2006. Total product revenue was $52.9 million for the second quarter of 2006, a year-over-year increase of 51%, compared to $35.1 million for the second quarter of 2005. Total product revenue for the first six months of 2006 was $94.7 million, a year-over-year increase of 48%. XIFAXAN(R) revenue for the second quarter of 2006 was $10.4 million, a 61% increase compared to the second quarter of 2005, and XIFAXAN revenue for the first six months of 2006 was $17.0 million, an 87% increase compared to the first six months of 2005. Prescription growth over the same comparable time periods was 122% and 135%, respectively. COLAZAL(R) generated revenue of $23.2 million for the second quarter of 2006 compared to $26.8 million for the second quarter of 2005. COLAZAL generated revenue of $46.1 million for the first six months of 2006 compared to $50.6 million for the first six months of 2005. COLAZAL prescriptions increased 11% year-over-year for the second quarter and first six months of 2006, so these decreases of COLAZAL sales reflect a draw-down of wholesaler inventories during the periods. Our bowel cleansing franchise, which in the second quarter was comprised of two marketed products, VISICOL(R) and the newly-approved OSMOPREP(TM), generated revenue of $17.5 million for the second quarter of 2006, compared to VISICOL revenue of $5.6 million a year ago when InKine, which we acquired in September 2005, was independent. In announcing the results, Carolyn Logan, President and Chief Executive Officer, said, "The Company continues to successfully execute its strategy to broaden and diversify its product line and to reduce its dependence on COLAZAL. Inflammatory bowel disease inflammatory bowel disease n. Abbr. IBD Any of several incurable and debilitating diseases of the gastrointestinal tract characterized by inflammation and obstruction of parts of the intestine. is an important component of our business and COLAZAL, as well as our IBD IBD abbr. inflammatory bowel disease Inflammatory bowel disease (IBD) Disease in which the lining of the intestine becomes inflamed. Mentioned in: Amebiasis IBD 1. products in development, will continue to be an important part of Salix. The expansion of our business beyond IBD, however, into bacteria-related disease and bowel cleansing will reduce the Company's dependence on COLAZAL. In the near term, the growing acceptance of XIFAXAN and the introduction of OSMOPREP and MOVIPREP, and in the longer term, the expanded label for XIFAXAN and the launch of additional new products, if successful, will serve to strengthen, expand and diversify the Company's revenue base." The chart below reveals the changing product mix and diversity of our revenue base:
REVENUE CONTRIBUTION
(Q % of Total Product Revenue)
Product 2Q2006 1Q2006 2Q2005 2Q2004
---------------------------------------------------------
COLAZAL 44% 55% 76% 97%
XIFAXAN 20% 16% 19% n/a
VISICOL 13% 23% n/a n/a
OSMOPREP 20% n/a n/a n/a
Other 3% 6% 5% 3%
Total cost of products sold was $9.2 million for the second quarter and $17.5 million for the first six months of 2006. Gross margin on total product revenue was 82.5% for the second quarter and 81.5% for the first six months of 2006, compared to 79.2% and 78.0%, respectively, for the corresponding periods of 2005. Research and development expenses were $11.7 million for the second quarter of 2006, compared to $5.7 million for the prior year period. Research and development expenses were $21.8 million for the first six months of 2006, compared to $10.0 million for the first six months of 2005. The increase in R&D expenses during the second quarter was primarily due to the expansion of our COLAZAL life cycle management program initiatives to strengthen and support our 1100 mg balsalazide tablet submission, our COLAZAL pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. exclusivity filing and the costs associated with ongoing, late-stage studies to expand the XIFAXAN label. Selling, general and administrative expenses were $23.4 million for the second quarter of 2006 and $42.8 million for the first six months of 2006, compared to $16.8 million and $31.0 million, respectively, for the corresponding periods of 2005. The increase in SG&A expenses, as expected, is primarily due to costs associated with launch activities for our two new purgative purgative /pur·ga·tive/ (purg´it-iv) cathartic (1, 2). pur·ga·tive n. An agent used for purging the bowels. adj. Tending to cause evacuation of the bowels. products and the expansion of the sales force subsequent to the InKine merger. Our sales force was trained on both OSMOPREP and MOVIPREP at our National Sales Meeting held in June 2006. During the second quarter of 2006 the Company experienced two non-cash, one-time charges. One charge was a $676,000 other comprehensive loss related to deferred revenue from the Shire Pharmaceuticals Group plc purchase from Salix in 2000 of the exclusive rights to balsalazide for northern Europe. The other charge was $270,000 related to the renewal of the sublease of the Company's former corporate headquarters. On a non-GAAP basis, excluding the charges mentioned above, net income for the second quarter of 2006 was $7.8 million, or $0.16 per share, fully diluted. GAAP GAAP See: Generally Accepted Accounting Principles GAAP See generally accepted accounting principles (GAAP). net income for the second quarter was $6.9 million, or $0.14 per share, fully diluted. On a non-GAAP basis, excluding the charges mentioned above, net income for the first six months of 2006 was $11.5 million, or $0.24 per share, fully diluted. GAAP net income for the first six months of 2006 was $10.6 million, or $0.22 per share, fully diluted. Net income for the second quarter and first six months of 2006 compares to net income of $5.0 million, or $0.13 per share, for the second quarter of 2005 and net income of $8.4 million, or $0.22 per share, for the first six months of 2005. Important disclosure about and quantitative reconciliation of this GAAP and non-GAAP information is in the financial tables following this release. Cash, cash equivalents and investments were $68.2 million on June 30, 2006, approximately the amount we had on December 31, 2005. Compared to March 31, 2006; cash, cash equivalents and investments increased $9.1 million. Commenting on the performance of the Company, Adam Derbyshire, Senior Vice President and Chief Financial Officer, stated, "Year-over-year total product revenue growth was driven by impressive gains for sales of XIFAXAN and the addition of our bowel cleansing products. During the second quarter of 2006 the Company continued to invest additional resources to expedite key R&D projects such as our COLAZAL life cycle management program, as well as our COLAZAL pediatric exclusivity filing. Based upon target enrollment for all ongoing clinical trials for the remainder of 2006, we continue to anticipate research and development expenses will be approximately 25% of total product revenue for 2006. We continue to expect selling, general and administrative expenses for 2006, which include the June OSMOPREP launch and the anticipated mid-fourth quarter MOVIPREP launch, to be approximately 38% of total product revenue. "For 2006, we continue to expect total Company product revenue will be approximately $205 million, and we continue to expect that we will be able to deliver earnings per share of approximately $0.65, on a fully diluted basis, assuming a 5% tax rate, for 2006. We will consider whether to adjust 2006 total product revenue guidance based upon the launch of MOVIPREP and our ongoing evaluation of wholesaler inventories. "Based upon current run rates, we anticipate XIFAXAN wholesaler inventories will be approximately 8 weeks (2.0 months) prior to year-end and COLAZAL wholesaler inventories to be approximately 8 weeks (2.0 months) at year-end." In commenting on XIFAXAN's strong growth during the second quarter, Ms. Logan said, "More XIFAXAN tablets were prescribed during the first six months of 2006 than were prescribed during the entire twelve months of 2005. Total XIFAXAN prescriptions increased 29% during the second quarter compared to the first quarter of 2006 and increased 154% for the month of June 2006 compared to June 2005. The utilization and acceptance of XIFAXAN continues to increase as more physicians gain exposure and experience with XIFAXAN. Digestive Disease Week 2006, which took place in May, provided the opportunity for physicians to learn more about XIFAXAN. The Annual Meeting of the American College of Gastroenterology The American College of Gastroenterology (ACG) is a Bethesda, Maryland-based medical association of gastroenterologists. The association was founded in 1932 and holds annual meetings and regional postgraduate continuing education courses, establishes research grants, (ACG ACG American College of Gastroenterology; angiocardiography; apexcardiogram. AcG accelerator globulin (coagulation factor V). AcG accelerator globulin (clotting factor V). ), which will take place in October, will serve as another venue for exposure for XIFAXAN. Currently we are aware of 19 XIFAXAN abstracts that have been accepted for presentation at ACG. We anticipate that a high level of interest will be generated by this unprecedented number of presentations on this important, broad-spectrum, gut-specific antibiotic. Significant strides were made during the quarter to further strengthen the intellectual property position of XIFAXAN. In May, we secured a composition of matter and process patent that extends patent coverage until 2024. Additionally, in July we signed an agreement with Cedars-Sinai Medical Center Cedars-Sinai Medical Center is a world-renowned hospital located in Los Angeles, California. History Cedars-Sinai is the result of a merger in 1961 between two major Los Angeles hospitals, Cedars of Lebanon and Mount Sinai Home for the Incurables, with Steve Broidy as for the right to use a patent and a patent application relating to methods of diagnosing and treating irritable bowel syndrome irritable bowel syndrome (IBS), condition characterized by frequently alternating constipation and diarrhea in the absence of any disease process. It is usually accompanied by abdominal pain, especially in the lower left quadrant, bloating, and flatulence. and other disorders caused by small intestinal bacterial overgrowth intestinal bacterial overgrowth Afferent loop syndrome, gastrojejunal loop obstruction, stagnant loop syndrome Infectious disease A condition characterized by excess growth of opportunistic bacteria, which occurs when normal gut flora is eradicated with antibiotics . These achievements serve to strengthen our XIFAXAN life cycle management program. "The approval of OSMOPREP in March and the approval of MOVIPREP last week signals Salix's advance into the bowel cleansing market. Strategically, the bowel cleansing market is closely aligned with our business. The gastroenterologists whom our sales representatives are currently calling on routinely perform colonoscopies in order to diagnose and monitor their patients. In fact, nearly 80% of all bowel prep bowel prep A preoperative enema, often used with prophylactic oral and parental antibiotics to purge the colon of food and feces before intestinal surgery; the most popular agent for preparing the large intestine for surgery is polyethylene glycol for mechanical prescriptions are written by gastroenterologists. We anticipate that in 2006, in the United States, over 10 million procedures requiring a bowel prep will be performed. Demographically, the bowel cleansing market is growing. Currently, in the United States, 85 million individuals are 50 years of age or older and are eligible for annual colon cancer colon cancer, cancer of any part of the colon (often called the large intestine). Colon cancer is the second most common cancer diagnosed in the United States. screening by colonoscopy. That population segment is expected to grow at a nearly 2% compounded annual growth rate over the next five years. We believe that our ability to provide both a tolerable tablet bowel cleansing agent and a tolerable two-liter liquid bowel cleansing agent creates an unprecedented opportunity for Salix to establish a leadership position in this important and growing market. We launched OSMOPREP in June and have been very encouraged with the reception it has received. Uptake has exceeded our expectations, and we look forward to continued expansion of our OSMOPREP business as more and more physicians and patients experience success with this reliable and tolerable product. We expect to launch MOVIPREP during mid-fourth quarter of 2006. We believe MOVIPREP should gain ready acceptance due to the fact that it is a two-liter PEG product and that it is the only two-liter PEG product that does not require the concomitant use of the laxative laxative, drug or other substance used to stimulate the action of the intestines in eliminating waste from the body. The term laxative usually refers to a mild-acting substance; substances of increasingly drastic action are known as cathartics, purgatives, bisacodyl. These features should make MOVIPREP a very competitive product. We look forward to the exposure OSMOPREP and MOVIPREP should receive this fall at ACG. Seven posters will be presented on a multi-center superiority trial in which OSMOPREP demonstrated superiority in colon cleansing, patient tolerability, patient preference and safety profile compared to the current market leader, HalfLytely(R) with Bisacodyl Tablets Bowel Prep Kit. "COLAZAL continued to demonstrate steady growth during the second quarter of 2006. Prescriptions grew 11% year-over-year for the second quarter and grew 3% compared to the first quarter of 2006. Over the past 12 months, as planned, COLAZAL's contribution as a percentage of total product revenue has begun to incrementally decrease as our product portfolio continues to expand and as XIFAXAN sales continue to ramp. COLAZAL sales contributed 44% of total product revenue during the second quarter of 2006 compared to 76% and 97% of total product revenue during the second quarter of 2005 and 2004, respectively. COLAZAL has served as a valuable entree for the Company into the inflammatory bowel disease market. The Company values its IBD business and is investing to expand its product offerings in this market with the development of the 1100 mg balsalazide tablet and granulated gran·u·late v. gran·u·lat·ed, gran·u·lat·ing, gran·u·lates v.tr. 1. To form into grains or granules. 2. To make rough and grainy. v.intr. mesalamine. Patient enrollment continued for both of these programs during the quarter, and we anticipate that in mid-2007 we will submit regulatory packages seeking marketing approval for these products. These products complement COLAZAL and should enable us to continue to grow and expand our IBD business. "As the Company has stated previously, for several years we have been actively engaged in conducting a COLAZAL life cycle management program in order to optimize the value of our IBD franchise. The Company continues to systematically and thoughtfully execute scientific and legal strategies designed to maximize COLAZAL's commercial success. "The Company will continue to focus on creating the leading specialty pharmaceutical company providing products to gastroenterologists and their patients. We will continue to execute our proven business plan of introducing new products as evidenced by two recent approvals, expanding current product offerings via label expansion and leveraging our dedicated specialty sales force. We believe that Salix's value will be fully recognized and fairly valued as we continue to build on organic growth from our existing marketed products, opportunities arising from an unmatched portfolio of products in late-stage development, additional new product opportunities and a sales force that sets the standard in the specialty pharmaceutical industry." The Company will host a conference call to discuss the contents of this press release at 9:00 a.m. ET, on Tuesday, August 8, 2006. 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. A replay of the web cast will be available at the same location. The telephone numbers to access the conference call are (800) 310-1961 (U.S. and Canada) or (719) 457-2692 (international.) The access code for the call is 2262984. A replay of the call will be available beginning at 12:00 noon ET. 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 2262984. Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina For other uses of this name, see Raleigh. Raleigh (IPA: /ˈrɑli/, ral-ee) is the capital of the State of North Carolina and the county seat of Wake County. , 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 any required development and regulatory submission of these products, and market them through the Company's 150-member gastroenterology specialty sales and marketing team. COLAZAL(R) (balsalazide disodium balsalazide disodium Colazide (UK), Colazal Pharmacologic class: GI agent Therapeutic class: Anti-inflammatory Pregnancy risk category B Action) Capsules 750 mg, is an anti-inflammatory drug approved for the treatment of mildly to moderately active ulcerative colitis ulcerative colitisInflammation of the colon, especially of its mucous membranes. The inflamed membranes develop patches of tiny ulcers, and the diarrhea contains blood and mucus. . Safety and effectiveness of COLAZAL beyond 12 weeks has not been established. 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 arthralgia /ar·thral·gia/ (ahr-thral´jah) pain in a joint. ar·thral·gia n. Severe pain in a joint. Also called arthrodynia. (4%). Withdrawal from therapy due to adverse events was comparable to placebo. XIFAXAN(R) (rifaximin) tablets 200 mg are indicated for the treatment of patients (greater than or equal to 12 years of age) with travelers' diarrhea trav·el·ers' diarrhea or trav·el·er's diarrhea n. Diarrhea and abdominal cramps occurring among travelers to regions where sanitation is poor, commonly caused by a toxin-producing strain of the bacterium Escherichia coli. caused by noninvasive strains of Escherichia coli Escherichia coli (ĕsh'ərĭk`ēə kō`lī), common bacterium that normally inhabits the intestinal tracts of humans and animals, but can cause infection in other parts of the body, especially the urinary tract. . XIFAXAN should not be used in patients with diarrhea complicated by fever or blood in the stool or diarrhea due to pathogens other than Escherichia coli. XIFAXAN should be discontinued if diarrhea symptoms get worse or persist more than 24-48 hours and alternative antibiotic therapy should be considered. In clinical trials, XIFAXAN was generally well tolerated. The most common side effects Side effects Effects of a proposed project on other parts of the firm. (vs. placebo) were flatulence flatulence /flat·u·lence/ (flat´u-lens) excessive formation of gases in the stomach or intestine. flat·u·lence or flat·u·len·cy n. The presence of excessive gas in the digestive tract. 11.3% (vs. 19.7%), headache 9.7% (vs. 9.2%), abdominal pain 7.2% (vs. 10.1 %) and rectal tenesmus tenesmus /te·nes·mus/ (te-nez´mus) straining, especially ineffectual and painful straining at stool or urination.tenes´mic te·nes·mus n. 7.2% (vs. 8.8%). VISICOL(R) Tablets (sodium phosphate monobasic monobasic /mono·ba·sic/ (-ba´sik) having but one atom of replaceable hydrogen. mon·o·ba·sic adj. 1. Having only one hydrogen ion to donate to a base in an acid-base reaction. monohydrate mon·o·hy·drate n. A compound, such as calcium chloride monohydrate, that contains one molecule of water. , USP USP - unique sales point , sodium phosphate dibasic dibasic /di·ba·sic/ (di-ba´sik) containing two replaceable hydrogen atoms, or furnishing two hydrogen ions. di·ba·sic adj. 1. Containing two replaceable hydrogen atoms. 2. anhydrous an·hy·drous adj. Without water, especially water of crystallization. anhydrous (anhī´drus), adj without water. anhydrous containing no water. , USP) are indicated for cleansing of the bowel as a preparation for colonoscopy, in adults 18 years of age or older. VISICOL(R) Tablets are the only FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approved tablets available to adults for bowel preparation Bowel Preparation Definition Bowel preparation is a procedure usually undertaken before a diagnostic procedure or treatment can be initiated for certain colorectal diseases. prior to colonoscopy. VISICOL Tablets are virtually taste-free, can be taken with any clear liquid such as water, lemonade or ginger ale, and have been proven to be associated with significantly less nausea, vomiting and bloating bloating Vox populi A lay term for post-prandial abdominal fullness or swelling than the leading, currently-available, prescribed class of liquid bowel preparations. VISICOL Tablets are not to be used in patients with congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. , ascites Ascites Definition Ascites is an abnormal accumulation of fluid in the abdomen. Description Rapidly developing (acute) ascites can occur as a complication of trauma, perforated ulcer, appendicitis, or inflammation of the colon or other , unstable angina un·sta·ble angina n. Angina pectoris characterized by pain of coronary origin that occurs in response to less exercise or other stimuli than usually required to produce pain. pectoris, gastric retention, ileus Ileus Definition Ileus is a partial or complete non-mechanical blockage of the small and/or large intestine. The term "ileus" comes from the Latin word for colic. or acute obstruction or pseudo-obstruction, severe chronic constipation, bowel perforation bowel perforation Gastrointestinal perforation GI disease Complete penetration of the intestinal wall resulting in bacterial contamination of the abdominal cavity/peritonitis , acute colitis, toxic megacolon toxic megacolon n. Acute dilation of the colon, seen in ulcerative colitis. Toxic megacolon Acute enlargement or dilation of the large intestine. or hypomotility syndrome. Use with caution in patients with impaired renal function, pre-existing electrolyte disturbances, or people taking drugs that affect electrolyte levels. OSMOPREP(TM) Tablets (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) are indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older. Considerable caution should be advised before OsmoPrep Tablets are used in patients with severe renal insufficiency renal insufficiency A defect in renal ability to 'clear' waste products, a sign of inadequate glomerular filtration , congestive heart failure, ascites, unstable angina, gastric retention, ileus, acute obstruction or pseudo-obstruction of the bowel, severe chronic constipation, bowel perforation, acute colitis, toxic megacolon, gastric bypass gastric bypass n. A surgical procedure used for treatment of morbid obesity, consisting of the severance of the upper stomach, anastomosis of the small upper pouch of the stomach to the jejunum, and closure of the distal part of the stomach. or stapling surgery, or hypomotility syndrome. Use with caution in patients with impaired renal function, patients with a history of acute phosphate nephropathy, known or suspected electrolyte disturbances (such as dehydration), or people taking drugs that affect electrolyte levels. Patients with electrolyte abnormalities such as hypernatremia Hypernatremia Definition The normal concentration of sodium in the blood plasma is 136-145 mM. Hypernatremia is defined as a serum sodium level over 145 mM. Severe hypernatremia, with serum sodium above 152 mM, can result in seizures and death. , hyperphosphatemia, hypokalemia Hypokalemia Definition Hypokalemia is a condition of below normal levels of potassium in the blood serum. Potassium, a necessary electrolyte, facilitates nerve impulse conduction and the contraction of skeletal and smooth muscles, including the heart. , or hypocalcemia Hypocalcemia Definition Hypocalcemia, a low bood calcium level, occurs when the concentration of free calcium ions in the blood falls below 4.0 mg/dL (dL = one tenth of a liter). The normal concentration of free calcium ions in the blood serum is 4.0-6. should have their electrolytes corrected before treatment with OsmoPrep Tablets. MOVIPREP(R) (PEG 3350, sodium sulfate sodium sulfate, chemical compound, Na2SO4. It is a white, orthorhombic crystalline compound at ordinary temperatures; above 100°C; it assumes a monoclinic structure, and above about 250°C; it assumes a hexagonal structure. , sodium chloride sodium chloride, NaCl, common salt. Properties Sodium chloride is readily soluble in water and insoluble or only slightly soluble in most other liquids. It forms small, transparent, colorless to white cubic crystals. , potassium chloride potassium chloride, chemical compound, KCl, a colorless or white, cubic, crystalline compound that closely resembles common salt (sodium chloride). It is soluble in water, alcohol, and alkalies. , sodium ascorbate a·scor·bate n. A salt of ascorbic acid. ascorbate a compound or derivative of ascorbic acid. See also sodium ascorbate. and ascorbic acid for oral solution) is indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older. MOVIPREP(R) should be used with caution in patients using concomitant medications that increase the risk of electrolyte abnormalities (such as diuretics Diuretics Definition Diuretics are medicines that help reduce the amount of water in the body. Purpose Diuretics are used to treat the buildup of excess fluid in the body that occurs with some medical conditions such as congestive heart or angiotensin converting enzyme Noun 1. angiotensin converting enzyme - proteolytic enzyme that converts angiotensin I into angiotensin II angiotensin-converting enzyme, ACE peptidase, protease, proteinase, proteolytic enzyme - any enzyme that catalyzes the splitting of proteins into (ACE)-inhibitors) or in patients with known or suspected hyponatremia Hyponatremia Definition The normal concentration of sodium in the blood plasma is 136-145 mM. Hyponatremia occurs when sodium falls below 130 mM. Plasma sodium levels of 125 mM or less are dangerous and can result in seizures and coma. . MOVIPREP(R) should also be used with caution in patients with severe ulcerative colitis, ileus, gastrointestinal obstruction or perforation per·fo·ra·tion n. 1. The act of perforating or the state of being perforated. 2. An abnormal opening in a hollow organ or viscus, as one made by rupture or injury. Perforation A hole. , gastric retention, toxic colitis, or toxic megacolon. In clinical trials, abdominal distension, anal discomfort, thirst, nausea and abdominal pain were some of the most common adverse reactions adverse reactions, n.pl unfavorable reactions resulting from administration of a local anesthetic; responsible factors include the drug used, concentration, and route of administration. to MOVIPREP(R) administration. Vomiting occurred less frequently. Salix also markets AZASAN(R) (azathioprine azathioprine: see metabolite. 75mg and 100mg tablets, USP), Anusol-HC(R) 2.5% (hydrocortisone hydrocortisone (hī'drəkôr`tĭzōn'), another name for the steroid hormone cortisol, more especially used to refer to preparations of this hormone used medicinally. Cream USP), Anusol-HC(R) 25 mg Suppository suppository /sup·pos·i·to·ry/ (su-poz´i-tor?e) an easily fusible medicated mass to be introduced into a body orifice, as the rectum, urethra, or vagina. sup·pos·i·to·ry n. (Hydrocortisone Acetate hydrocortisone acetate Cortifoam, Dricort, Micort-HC, Orabase HCA Pharmacologic class: Short-acting corticosteroid Therapeutic class: Anti-inflammatory (steroidal) Pregnancy risk category C ), Proctocort(R) Cream (Hydrocortisone Cream USP) 1% and Proctocort(R) Suppositories suppositories, n.pl solid capsules made of materials that melt at body temperature and are used to deliver medicinal substances into the rectum. (Hydrocortisone Acetate Rectal Suppositories, 30 mg). Granulated mesalamine is under development. For full prescribing information on Salix products, please visit www.salix.com. Salix trades on the NASDAQ Global 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. Information on our web site is not incorporated in our SEC filings. AZASAN(R) is a registered trademark of AAI AAI American Association of Immunologists. Properties Inc. MOVIPREP(R) is a registered trademark of Velinor A.G. Table follows 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 potential generic and other competition, management of rapid growth, risks of regulatory review and clinical trials, market acceptance for approved products, intellectual property risks, and the need to acquire additional products. The reader is referred to the documents that the Company files from time to time with the Securities and Exchange Commission.
Salix Pharmaceuticals, Ltd.
Condensed Consolidated Statements of Operations
(In thousands, except per share data)
Three Months Ended Six Months Ended
June 30, June 30, June 30, June 30,
2006 2005 2006 2005
(unaudited)(unaudited)(unaudited)(unaudited)
--------------------------------------------
Revenues:
Net product revenues $52,853 $35,118 $94,706 $63,928
------- ------- ------- -------
Total revenues 52,853 35,118 94,706 63,928
Operating Costs and
Expenses:
Cost of products sold 9,237 7,296 17,522 14,044
License fees and costs
related to
collaborative and co-
promotion agreements 200 - 200 -
Amortization of
intangible assets 1,135 381 2,270 762
Research and
development 11,688 5,671 21,816 9,956
Selling, general and
administrative 23,415 16,799 42,834 30,992
------- ------- ------- -------
Total operating
costs and expenses 45,675 30,147 84,642 55,754
Income from operations 7,178 4,971 10,064 8,174
Interest and other
income, net 21 166 991 415
Income tax expense 264 139 457 232
------- ------- ------- -------
Net income $ 6,935 $ 4,998 $10,598 $ 8,357
======= ======= ======= =======
Net income per share,
basic $ 0.15 $ 0.14 $ 0.23 $ 0.23
======= ======= ======= =======
Net income per share,
diluted $ 0.14 $ 0.13 $ 0.22 $ 0.22
======= ======= ======= =======
Weighted average shares
outstanding, basic 46,549 36,708 46,454 36,630
======= ======= ======= =======
Weighted average shares
outstanding, diluted 48,146 38,791 48,303 38,744
======= ======= ======= =======
Reconciliation of GAAP Amounts to Non-GAAP Amounts:
(In thousands, except per share data)
We are disclosing net income and net income per share, as adjusted
to eliminate various charges that we incurred in the second quarter of
2006. We use these non-GAAP measures to analyze our business because
these charges did not involve cash and were not related to ongoing
operations, so eliminating them helps us better compare our
performance to other periods. For these reasons, we also think this
information might be helpful to investors, but you should be aware
that non-GAAP measures are not superior to nor a substitute for the
comparable GAAP measures. A reconciliation of our non-GAAP measures to
the comparable GAAP measures follows.
Three Months Ended Six Months Ended
June 30, June 30, June 30, June 30,
2006 2005 2006 2005
(unaudited)(unaudited)(unaudited)(unaudited)
--------------------------------------------
GAAP Net income $ 6,935 $ 4,998 $10,598 $ 8,357
Non-GAAP Adjustment
Items:
One-time non-cash
charge associated
with a sub-lease
renewal (net of tax) 259 - 259 -
One-time non-cash
other comprehensive
loss (net of tax) 648 - 648 -
------- ------- ------- -------
Non-GAAP Net income, as
adjusted $ 7,842 $ 4,998 $11,505 $ 8,357
======= ======= ======= =======
Non-GAAP Net income per
share, basic $ 0.17 $ 0.14 $ 0.25 $ 0.23
======= ======= ======= =======
Non-GAAP Net income per
share, diluted $ 0.16 $ 0.13 $ 0.24 $ 0.22
======= ======= ======= =======
Weighted average shares
outstanding, basic 46,549 36,708 46,454 36,630
======= ======= ======= =======
Weighted average shares
outstanding, diluted 48,146 38,791 48,303 38,744
======= ======= ======= =======
Salix Pharmaceuticals, Ltd.
Condensed Consolidated Balance Sheets
(In thousands)
June 30, December 31,
2006 2005
(unaudited) (audited)
-----------------------
Assets
Cash, cash equivalents and investments $ 68,173 $ 68,182
Accounts receivable, net 38,355 38,852
Inventory, net 23,629 23,164
Other assets 153,147 152,274
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Total Assets $ 283,304 $ 282,472
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Liabilities and Stockholders' Equity
Accounts payable and other liabilities $ 30,433 $ 42,619
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Total liabilities 30,433 42,619
Common stock 47 46
Additional paid-in-capital 386,699 384,959
Other comprehensive loss - (679)
Accumulated deficit (133,875) (144,473)
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Total stockholders' equity 252,871 239,853
--------- ----------
Total Liabilities and Stockholders' Equity $ 283,304 $ 282,472
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