8-K

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) October 31, 2008

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)
1700 Perimeter Park Drive, Morrisville, North Carolina	27560
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code (919) 862-1000

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:

¨ 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 November 5, 2008, Salix Pharmaceuticals, Ltd. issued a press release announcing its financial and operating results for the third quarter ended September 30, 2008. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein in its entirety by reference.

The information in this Item 2.02 (including Exhibit 99.1) shall not be deemed “ filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 8.01. Other Events.

On October 31, 2008, Salix Pharmaceuticals, Ltd. issued a press release announcing that the U.S. Food and Drug Administration has granted marketing approval for APRISO™ for maintenance of remission of ulcerative colitis. A copy of the press release is attached hereto as Exhibit 99.2 and is incorporated herein in its entirety by reference.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
99.1	Press release dated November 5, 2008.
99.2	Press release dated October 31, 2008.

SIGNATURE

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 thereunto duly authorized.

	SALIX PHARMACEUTICALS, LTD.
Date: November 5, 2008
	/s/ Adam C. Derbyshire
	Adam C. Derbyshire
	Senior Vice President and Chief Financial Officer

EX-99.1

Exhibit 99.1

FOR IMMEDIATE RELEASE

Contact:	Adam C. Derbyshire	G. Michael Freeman
	Senior Vice President and Chief Financial Officer	Associate Vice President, Investor Relations and Corporate Communications
	919-862-1000	919-862-1000

SALIX PHARMACEUTICALS REPORTS

3Q2008 RESULTS

XIFAXAN and Bowel Cleanser Revenue Increases 31% Over

3Q2007

APRISO™ Granted FDA Marketing Approval

Rifaximin Pivotal Phase 3 Results in Hepatic Encephalopathy are

Highly Statistically Significant

Revised ACG Guidelines for IBS Incorporate Rifaximin

RALEIGH, NC, November 5, 2008—Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced financial and operating results for the third quarter ended September 30, 2008.

Total product revenue was $42.9 million for the third quarter of 2008, compared to $67.4 million for the third quarter of 2007. Total product revenue for the first nine months of 2008 was $118.2 million compared to $193.8 million for the first nine months of 2007. The decrease in total product revenue for the quarter and nine months was due to the genericization of COLAZAL^® on December 28, 2007. XIFAXAN^® revenue for the third quarter of 2008 was $21.4 million, a 33% increase compared to the third quarter of 2007. XIFAXAN revenue for the first nine months of 2008 was $56.1 million compared to $47.3 million for the first nine months of 2007, an increase of 19%. MOVIPREP^®, OSMOPREP^® and VISICOL^®, which comprise our bowel cleansing product line, generated revenue of $15.5 million for the third quarter of 2008, compared to $12.1 million for the third quarter of 2007, a 28% increase. Total product revenue for our bowel cleansing product line was $41.5 million for the first nine months of 2008 and $34.6 million for the first nine months of 2007, a 20% increase.

Total cost of products sold was $7.8 million for the third quarter and $22.1 million for the first nine months of 2008. Gross margin on total product revenue was 81.9% for the third quarter of 2008 compared to 80.6% for the third quarter of 2007 and 81.3% for the first nine months of 2008, compared to 80.3% for the first nine months of 2007. Research and development expenses were $14.4 million for the third quarter of 2008 and $55.7 million for the first nine months of 2008, compared to $16.0 million and $56.8 million, respectively, for the prior year periods. Selling, general and administrative expenses were $23.4 million for the third quarter of 2008, compared to $20.9 million for the third quarter of 2007, and these expenses were $67.6 million and $64.1 million for the first nine months of 2008 and 2007, respectively. The Company reported a net loss of $5.4 million, or $0.11 per share, fully diluted, for the third quarter of 2008.

Cash and cash equivalents were $121.9 million on September 30, 2008.

Commenting on the performance of the Company, Adam Derbyshire, Senior Vice President and Chief Financial Officer, stated, “Combined product revenue from XIFAXAN and our bowel cleansing products achieved year-over-year growth of 31% for the third quarter of 2008. We continue to believe several factors should contribute to an increase in product revenue over the coming years, namely the continued growth of our currently marketed products, the launch of new products currently undergoing FDA review, the expanded contribution of rifaximin if additional indications are approved and the further expansion of our product portfolio via development activities, licensing and acquisitions.

“In August the Company closed a $60 million convertible note offering. This funding should facilitate our ability to finance development and licensing activities and acquisitions in a timely fashion.

“We believe total Company product revenue for 2008 will be approximately $178 million to $180 million, including the revenue associated with the initial stocking of APRISO (mesalamine) extended-release capsules 0.375 g. The current annualized run rates, based on dollarizing the latest prescription data for XIFAXAN, our bowel cleansing product line and other products are approximately $84 million, $67 million, and $31 million, respectively.

“With a third quarter loss of $0.11, we anticipate generating a loss of approximately $0.90 per share, fully diluted, for the year ending December 31, 2008 compared to our previous guidance of a loss of approximately $1.02 for the year. This improvement in guidance for 2008 reflects a change in research and development expenditures for the year. Even though enrollment in our phase 3 IBS trials is progressing ahead of goal, research and development expense for the year will be approximately $8 million less than previous guidance primarily due to the timing of certain smaller supportive studies and the elimination of other smaller studies related to rifaximin and the timing of the initiation of studies related to budesonide foam.”

Carolyn Logan, President and Chief Executive Officer stated, “Our proprietary products continued to grow and progress during the third quarter of 2008. XIFAXAN prescriptions grew 10% year-over-year for the third quarter and 8% for the first nine months of 2008. Prescription demand for our bowel cleansing products grew 13% and 16%, respectively, for the third quarter and first nine months of 2008 compared to the corresponding periods of 2007.

“Recent highlights focus on the progress made in both the hepatic encephalopathy (HE) and irritable bowel syndrome (IBS) development programs for rifaximin and the approval of APRISO, our extended-release capsule formulation of mesalamine. In early October we were pleased to announce the successful completion and outcome of our pivotal Phase 3 trial to evaluate the efficacy, safety and tolerability of rifaximin in preventing hepatic encephalopathy. The study demonstrated that a 6-month course of rifaximin dosed at 550 mg twice-daily provides a highly statistically significant result in preventing HE, compared to placebo. Additionally, this primary result was corroborated by the secondary endpoints. Hepatic encephalopathy is a serious medical condition that often results in hospitalization and has no FDA-approved drug therapies available for preventing this relapsing condition. It is our belief that the market is poised for an effective treatment that will work to alleviate the great economic, social, familial and personal burden resulting from this debilitating disease. We look forward to completing and submitting the NDA during the first quarter of 2009. Rifaximin has been granted orphan drug designation by the United States Food and Drug Administration for use in hepatic encephalopathy. We believe that this designation will provide seven years of marketing exclusivity in the United States if rifaximin gains approval from the FDA for HE.

“During the third quarter of 2008 patient enrollment progressed ahead of goal in TARGET 1 and TARGET 2, our two 600-subject trials to assess the efficacy and safety of rifaximin 550 mg, dosed three times daily, in the treatment of subjects with non-constipation irritable bowel syndrome. Irritable bowel syndrome is among one of the most common chronic conditions and affects approximately 15% of adults in the United States. Based on the most current understanding of IBS and the alterations of bacterial flora in the gut as a potential factor in IBS, we believe rifaximin may be a strong treatment candidate.

“The irritable bowel syndrome and hepatic encephalopathy indications present significant potential for the future growth of Salix. Currently we estimate the commercial opportunity represented by these markets combined is approximately $2.8 billion.

“This year’s American College of Gastroenterology (ACG) Annual Scientific Meeting provided a venue for widespread exposure and discussion related to our products and product candidates. Four scientific posters and one oral presentation discussed the use of mesalamine granules in the maintenance of remission of ulcerative colitis. Thirteen scientific posters presented results of investigator-initiated studies investigating the potential use of rifaximin for a variety of indications. Members of the ACG’s expert panel on IBS presented a preview of the College’s revised draft treatment guidelines for IBS. We are pleased that the panel highlighted the guidelines’ recommendation for the use of antibiotics, notably the non-absorbed agent rifaximin. The final guidelines are scheduled for publication in January 2009 as a supplement to the American Journal of Gastroenterology. Salix currently is assessing the use of rifaximin in the treatment of IBS.

“We were pleased to announce the marketing approval of APRISO last week. APRISO is the first and only once-a-day mesalamine product for the maintenance of remission of ulcerative colitis. We believe APRISO’s patent-protected Intellicor™ delivery system provides a delivery profile that physicians and patients will find beneficial in maintaining remission of ulcerative colitis. We intend to begin stocking the product with wholesalers in December and January and to launch the product to physicians during the first quarter of 2009.

“The review of the METOZOLV™ ODT (metoclopramide) and balsalazide tablet NDAs continued to progress during the third quarter. We continue to anticipate a decision from the FDA on METOZOLV by November 28 and balsalazide tablet by December 30, 2008.”

The Company will host a conference call at 5:00 p.m. ET, on Wednesday, November 5, 2008. Interested parties can access the conference call by way of web cast or telephone. The live web cast will be available at www.salix.com. A replay of the web cast will be available at the same location. The telephone numbers to access the live conference call are (877) 857-6177 (U.S. and Canada) or (719) 325-4796 (international). 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 4531858.

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 any required development and regulatory submission of these products, and market them through the Company’s gastroenterology specialty sales and marketing team.

APRISO™ is a locally-acting aminosalicylate indicated for the maintenance of remission of ulcerative colitis in patients 18 years and older. APRISO is contraindicated in patients with hypersensitivity to salicylates, aminosalicylate, or to any of the components of APRISO capsules. The recommended dose of APRISO is four 0.375 g capsules once daily in the morning (1.5 g/day) with or without food. Because dissolution of the coating of APRISO granules depends on pH, APRISO should not be coadministered with antacids. Patients with phenylketonuria should be aware that APRISO contains aspartame, equivalent to 0.56 mg of phenylalanine. In two well-controlled clinical trials, the most common treatment-related adverse events occurring in greater than 3% of adult patients taking 1.5 g/day of APRISO (versus placebo) were headache (11% vs 8%), diarrhea (8% vs 7%), upper abdominal pain (5% vs 3%), nausea (4% vs 3%), nasopharyngitis (4% vs 3%), influenza and influenza-like illness (4% vs 4%) and sinusitis (3% vs 3%).

Salix markets XIFAXAN^® (rifaximin) tablets 200 mg, OSMOPREP^® (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets, MOVIPREP^® (PEG 3350,

Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid for Oral Solution), VISICOL^® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets, COLAZAL^® (balsalazide disodium) Capsules 750 mg, PEPCID^® (famotidine) for Oral Suspension, Oral Suspension DIURIL^® (Chlorothiazide), AZASAN^® Azathioprine Tablets, USP, 75/100 mg, ANUSOL-HC^® 2.5% (Hydrocortisone Cream, USP), ANUSOL-HC^® 25 mg Suppository (Hydrocortisone Acetate), PROCTOCORT^® Cream (Hydrocortisone Cream, USP) 1% and PROCTOCORT^® Suppository (Hydrocortisone Acetate Rectal Suppositories) 30 mg. METOZOLV™ ODT (metoclopramide), balsalazide tablet, vapreotide acetate and rifaximin for additional indications are under development.

For full prescribing information on Salix products, please visit www.salix.com where the Company promptly posts press releases, SEC filings and other important information or contact the Company at (919) 862-1000.

Salix trades on the NASDAQ Global Select Market under the ticker symbol “SLXP”.

For more information please visit our web site at www.salix.com. Information on our web site is not incorporated in our SEC filings.

TABLE FOLLOWS

###

Please Note: The materials provided herein contain projections and other forward-looking statements regarding future events. Such 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, among others: the unpredictability of the duration and results of regulatory review of New Drug Applications and Investigational NDAs; generic and other competition and the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties; our need to return to profitability; the high cost and uncertainty of the research, clinical trials and other development activities involving pharmaceutical products; market acceptance for approved products and the need to acquire new 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						Nine Months Ended
	September 30, 2008 (unaudited)			September 30, 2007 (unaudited)			September 30, 2008 (unaudited)			September 30, 2007 (unaudited)
Revenues:
Net product revenues	$	42,872		$	67,355		$	118,197		$	193,818
Revenues from collaborative agreements		—			12			—			2,512
Total revenues		42,872			67,367			118,197			196,330
Costs and Expenses:
Cost of products sold		7,763			13,083			22,133			38,129
Fees and costs related to license agreements		—			200			1,605			1,650
Amortization of product rights and intangible assets		2,271			2,271			6,813			6,355
Research and development		14,442			15,992			55,698			56,805
Selling, general and administrative		23,411			20,891			67,555			64,102
Total costs and expenses		47,887			52,437			153,804			167,041
Income (loss) from operations		(5,015	)		14,930			(35,607	)		29,289
Interest and other income (expense), net		(512	)		1,443			98			2,645
Income (loss) before provision for income tax		(5,527	)		16,373			(35,509	)		31,934
Provision for income tax		112			(2,200	)		(992	)		(4,680	)
Net income (loss)	$	(5,415	)	$	14,173		$	(36,501	)	$	27,254
Net income (loss) per share, basic	$	(0.11	)	$	0.30		$	(0.76	)	$	0.58
Net income (loss) per share, diluted	$	(0.11	)	$	0.29		$	(0.76	)	$	0.56
Weighted average shares outstanding, basic		48,040			47,438			47,842			47,237
Weighted average shares outstanding, diluted		48,040			48,611			47,842			48,624

Salix Pharmaceuticals, Ltd.

Condensed Consolidated Balance Sheets

(In thousands)

	September 30, 2008 (unaudited)			December 31, 2007 (audited)
Assets
Cash and cash equivalents	$	121,881		$	111,272
Accounts receivable, net		40,706			52,208
Inventory, net		23,120			17,676
Other assets		235,120			215,946
Total Assets	$	420,827		$	397,102
Liabilities and Stockholders’ Equity
Accounts payable and other liabilities	$	161,224		$	104,532
Total liabilities		161,224			104,532
Common stock		48			47
Additional paid-in-capital		400,794			397,261
Accumulated deficit		(141,239	)		(104,738	)
Total stockholders’ equity		259,603			292,570
Total Liabilities and Stockholders’ Equity	$	420,827		$	397,102

EX-99.2

Exhibit 99.2

FOR IMMEDIATE RELEASE

Contact:	Adam C. Derbyshire	G. Michael Freeman
	Senior Vice President and Chief Financial Officer	Associate Vice President, Investor Relations and Corporate Communications
	919-862-1000	919-862-1000

APRISO™ GRANTED FDA MARKETING APPROVAL FOR MAINTENANCE OF REMISSION

OF ULCERATIVE COLITIS

APRISO™ First and Only 5-ASA with Intellicor™ Extended-Release Delivery and 24-Hour

Protection from Flare-Ups in a Once-Daily Dose

RALEIGH, NC, October 31, 2008 – Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for APRISO™ (mesalamine) extended-release capsules 0.375 g. APRISO is a locally-acting aminosalicylate indicated for the maintenance of remission of ulcerative colitis (UC) in adults. APRISO is the first and only mesalamine product approved by the FDA for once-a-day dosing for the maintenance of remission of ulcerative colitis. Additionally, APRISO is the first and only 5-ASA with Intellicor™ extended release delivery technology. The Company expects to launch APRISO to physicians during the first quarter of 2009. APRISO is patent protected until 2018.

Bill Forbes, Pharm. D., Vice President, Research and Development, and Chief Development Officer, Salix, stated, “APRISO is an important new once-daily treatment option that encourages compliance in ulcerative colitis patients and provides effective long-term protection from ulcerative colitis flare-ups. A major goal of UC therapy is to prevent relapse which may decrease the risk of disease progression. APRISO accomplishes this goal through the combination of an enteric pH-dependent coating which provides for a delayed release starting at a pH of 6.0 and a polymer matrix core, which provides for extended release. This patented delivery technology is designed to distribute the active ingredient beginning in the small bowel and continuing throughout the colon. Previous generation pH-dependent 5-ASA treatment options provide for release of the active ingredient starting at a pH of 7.0. According to published data, many people never reach a pH of 7.0 in their small or large intestine. APRISO represents a new and important advancement in 5-ASA drug delivery.”

The approval is based on results from two randomized, double-blind, placebo-controlled multi-center, multi-national studies totaling 562 adults in remission from ulcerative colitis. The studies showed that APRISO was more effective than placebo in maintaining long-term remission for six months. In both studies, the proportion of patients who remained relapse-free at six months was greater for APRISO than for placebo.

In these studies APRISO offered clinically-proven efficacy in extending both remission and relief of UC symptoms:

• Maintained remission for six months in 7 out of 10 UC patients in two clinical trials and

• Sustained improvement in rectal bleeding and bowel movement frequency.

APRISO’s patented Intellicor™ delivery system is the first and only to combine delayed and extended 5-ASA release.

• Unlike tablets, APRISO’s gelatin outer capsule quickly dissolves in the stomach to disperse microgranules into the digestive tract.

• Next, a delayed-release coating on the microgranules dissolves at pH 6.0 or higher.

• Last, an inner polymer matrix core controls the extended release of mesalamine to provide drug distribution throughout affected areas.

About Mesalamine Granules

APRISO™ is a locally-acting aminosalicylate indicated for the maintenance of remission of ulcerative colitis in patients 18 years and older. APRISO is contraindicated in patients with hypersensitivity to salicylates, aminosalicylates, or to any of the components of APRISO capsules. The recommended dose of APRISO is four 0.375 g capsules once daily in the morning (1.5 g/day) with or without food. Because dissolution of the coating of APRISO granules depends on pH, APRISO should not be coadministered with antacids. Patients with phenylketonuria should be aware that APRISO contains aspartame, equivalent to 0.56 mg of phenylalanine. In two well-controlled clinical trials, the most common treatment-related adverse events occurring in greater than 3% of adult patients taking 1.5

g/day of APRISO (versus placebo) were headache (11% vs 8%), diarrhea (8% vs 7%), upper abdominal pain (5% vs 3%), nausea (4% vs 3%), nasopharyngitis (4% vs 3%), influenza and influenza-like illness (4% vs 4%) and sinusitis (3% vs 3%).

Salix acquired rights to market APRISO in the U.S. from Dr. Falk Pharma GmbH of Freiburg, Germany. Mesalamine granules have been approved in Germany since 2001 for the treatment of symptoms related to inflammatory bowel disease. In addition, consistent with the FDA-approved labeling, once-daily dosing of mesalamine granules is currently approved via the mutual recognition procedure in Austria, Belgium, Denmark, Finland, Greece, Ireland, Luxemburg, Netherlands, Norway, Portugal, Sweden, Spain and the UK.

About Ulcerative Colitis

Ulcerative colitis is a chronic inflammatory disease of the colon or large intestine. The inflammation usually begins in the rectum and lower colon, but it may also involve the entire colon. Because the inflammation makes the colon empty frequently, symptoms typically include diarrhea (sometimes accompanied by blood) and often abdominal pain. About five percent of people with ulcerative colitis will develop colorectal cancer.

Patients with ulcerative colitis may experience periods of remission (times when the symptoms go away) that can last for months or years. However, most patients’ symptoms eventually return. Active therapy is treatment given to treat ulcerative colitis symptoms when they are active. Maintenance therapy refers to treatment given to patients to enable them to stay in remission, and to maintain their health in a disease-free, or limited-disease, state. Maintenance medications must be taken for a prolonged period of time.

About Salix Pharmaceuticals

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 with any required development and regulatory submission of these products, and market them through the Company’s gastroenterology specialty sales and marketing team.

About Dr. Falk Pharma

Dr. Falk Pharma GmbH is one of the most recognized companies worldwide in gastroenterology. Dr. Falk Pharma products are sold in more than 60 countries. The Falk Foundation, which is associated with the Company, provides medical information via international symposia, forums and postgraduate courses. Over the past 40 years the Falk Foundation has sponsored more than 200 symposia in which over 100,000 physicians from 110 countries have come together to advance knowledge in gastroenterology and hepatology.

Salix also markets XIFAXAN^® (rifaximin) tablets 200 mg, OSMOPREP^® (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets, MOVIPREP^® (PEG 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid for Oral Solution), VISICOL^® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets, COLAZAL^® (balsalazide disodium) Capsules 750 mg, PEPCID^® (famotidine) for Oral Suspension, Oral Suspension DIURIL^® (Chlorothiazide), AZASAN^® Azathioprine Tablets, USP, 75/100 mg, ANUSOL-HC^® 2.5% (Hydrocortisone Cream, USP), ANUSOL-HC^® 25 mg Suppository (Hydrocortisone Acetate), PROCTOCORT^® Cream (Hydrocortisone Cream, USP) 1% and PROCTOCORT^® Suppository (Hydrocortisone Acetate Rectal Suppositories) 30 mg. METOZOLV™ ODT (metoclopramide), balsalazide tablet, vapreotide acetate and rifaximin for additional indications are under development.

For full prescribing information on Salix products, please visit www.salix.com.

Salix trades on the NASDAQ Global Select Market under the ticker symbol “SLXP”.

For more information, please visit our Web site at www.salix.com or contact the Company at 919-862-1000. Information on our Web site is not incorporated into our SEC filings.

Please Note: The materials provided herein contain projections and other forward-looking statements regarding future events. Such 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, among others: market acceptance for approved products; our need to return to profitability; generic and other competition; the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties; and the need to acquire new products. The reader is referred to the documents that the Company files from time to time with the Securities and Exchange Commission.