Key Developments: Salix Pharmaceuticals Ltd (SLXP.O)
59.28USD
17 May 2013
$0.09 (+0.15%)
$59.19
$59.40
$59.56
$58.75
420,834
528,022
$60.20
$37.52
Latest Key Developments (Source: Significant Developments)
Salix Pharmaceuticals Ltd Issues Q2 2013 Earnings Guidance Below Analysts' Estimates; Issues FY 2013 EBITDA And EPS Guidance Above Estimates; Issues FY 2013 Net Income Guidance Below Estimates
Salix Pharmaceuticals Ltd announced that for second quarter of 2013, it expects GAAP net income of $31.5 million, EBITDA of $84.5 million, adjusted Non-GAAP net income of $50.0 million and adjusted Non-GAAP net income per share, fully diluted of $0.78. For fiscal 2013, it expects GAAP net income of $144.0 million, EBITDA of $368.0 million, adjusted Non-GAAP net income of $215.0 million and adjusted Non-GAAP net income per share, fully diluted of $3.37. According to I/B/E/S Estimates, analysts are expecting the Company to report EBITDA of $85 million, net income of $80 million and EPS of $0.79 for second quarter of 2013; EBITDA of $363 million, net income of $216 million and EPS of $3.36 for fiscal 2013. Full Article
Salix Pharmaceuticals Ltd Issues Q1 2013 Guidance; EBITDA Guidance Below Analysts' Estimates
Salix Pharmaceuticals Ltd announced that for the first quarter of 2013, it expects total product revenue to be approximately $200 million, EBITDA should be approximately $68 million and adjusted net income should be approximately $40 million, or $0.63 per share, fully diluted, on a non-GAAP basis. According to I/B/E/S Estimates, analysts are expecting the Company to report revenue of $207 million, EBITDA of $75 million, net income of $43 million and EPS of $0.67 for the first quarter of 2013. Full Article
Salix Pharmaceuticals Ltd Reaffirms FY 2012 Revenue Guidance-Conference Call
Salix Pharmaceuticals Ltd announced that for fiscal 2012, it expects $735 million in top-line revenue. Full Article
FDA Approves Salix Pharmaceuticals Ltd's Fulyzaq (Crofelemer) 125 mg Delayed-Release Tablets For The Symptomatic Relief Of Diarrhea In Patients With HIV/AIDS On Anti-Retroviral Therapy
Salix Pharmaceuticals Ltd announced that the Food and Drug Administration has approved Fulyzaq (crofelemer) 125 mg delayed-release tablets for the symptomatic relief of non-infectious diarrhea in adult patients with human immunodeficiency virus (HIV)/ acquired immune deficiency syndrome (AIDS) on anti-retroviral therapy (ART). The FDA approval of Fulyzaq is based on a randomized, double-blind, placebo-controlled (one month) and placebo-free (five month), multi-center study of 374 HIV-positive patients on ART, with a history of diarrhea for one month or more. The primary efficacy endpoint was the proportion of patients experiencing less than or equal to two watery bowel movements per week, during at least two of the four weeks of the placebo-controlled phase of the study. Patients who received concomitant anti-diarrheal medications or opiates were counted as clinical non-responders. Data demonstrated that a significantly larger proportion of patients taking Fulyzaq 125 mg twice daily experienced clinical response compared with patients in the placebo group. In addition, statistically reductions from baseline to the end of the double-blind period also were observed for the number of watery bowel movements per day, and daily stool consistency score, among patients taking Fulyzaq compared with placebo. Full Article
PhotoCure ASA Receives Payment for Development of Lumacan from Salix Pharmaceuticals Ltd
PhotoCure ASA announced that it has received a payment of USD 4.5 million from Salix Pharmaceuticals Ltd regarding development of Lumacan to date and the commitment to continue the development. Lumacan is a photodynamic colorectal diagnostic intended to significantly improve the detection of precancerous and cancerous lesions in the colon through fluorescence diagnosis. Photocure signed a strategic global agreement with Salix for the development and commercialization of Lumacan in October 2010. The collaboration with Salix is progressing well. Salix is currently developing an optimal oral formulation of Lumacan to be used in clinical studies. Full Article
Salix Pharmaceuticals Ltd Reaffirms FY 2012 Revenue Guidance; Raises FY 2012 Earnings Guidance
Salix Pharmaceuticals Ltd reaffirmed fiscal 2012 revenue guidance of $735 Million and increases guidance for adjusted net income to $200 million or $3.13, per share, fully diluted (EPS). According to I/B/E/S Estimates, analysts are expecting the Company to report net income of $185 million and EPS of $2.91 for fiscal 2012. Full Article
Salix Pharmaceuticals Ltd Announces FDA Continues Review Of Crofelemer New Drug Application Beyond PDUFA Goal Date Of September 5, 2012
Salix Pharmaceuticals Ltd announced that the Food and Drug Administration has advised the Company that its New Drug Application (NDA) for crofelemer 125 mg tablets, for the proposed indication of symptomatic relief of non-infectious diarrhea in patients with HIV/AIDS on anti-retroviral therapy, is still under review and that a final action will not be taken by the scheduled Prescription Drug User Fee Act (PDUFA) goal date of September 5, 2012. Crofelemer is a first-in-class anti-diarrheal botanical drug substance. Crofelemer has minimal absorption and no effect on gut motility. Crofelemer’s mechanism of action is through inhibition of both the cystic fibrosis transmembrane conductance regulator protein (CFTR) chloride ion channel and the calcium-activated chloride ion channels (CaCC). Full Article
Salix Pharmaceuticals, Ltd. and Alfa Wassermann Announce License Agreement for New Extended Intestinal Release Formulation of Rifaximin
Salix Pharmaceuticals, Ltd. Salix Pharmaceuticals, Ltd. announced that they have entered into an exclusive agreement by which Salix has licensed rights in the United States and Canada to an extended intestinal release (EIR) formulation of rifaximin for gastrointestinal and respiratory indications, including Crohn’s disease. The EIR formulation of rifaximin has been designed to release the active drug following passage through the stomach and provide a homogeneous distribution of rifaximin in the intestinal tract. The EIR formulation of rifaximin was designed to provide an efficient delivery of rifaximin and will be studied for its potential to target difficult to treat diseases of the intestinal tract such as Crohn’s disease. Financial terms of the transaction include a $10 million up-front payment and a $25 million development milestone payment upon NDA approval of an EIR formulation rifaximin product for Crohn’s disease. Salix also will pay sales-based milestones in respect of EIR formulation rifaximin products for Crohn’s disease, if sales targets are achieved, plus royalties on product sales of all EIR formulation rifaximin products. Alfa Wassermann will manufacture Salix’s requirements of EIR formulation rifaximin products. Full Article
Salix Pharmaceuticals, Ltd. Reaffirms FY 2012 Revenue Guidance; Raises FY 2012 Earnings Guidance
Salix Pharmaceuticals, Ltd. updated fiscal 2012 financial guidance. The estimates fiscal 2012 total Company product revenue remains approximately $735 million, increased fiscal 2012 adjusted net income to approximately $183 million or $2.86 per share. According to I/B/E/S Estimates, analysts are expecting the Company to report revenues of $742 million, net income of $173 million and EPS of $2.65 for fiscal 2012. Full Article
Salix Pharmaceuticals, Ltd. And Progenics Pharmaceuticals, Inc. Receive Complete Response Letter From FDA For RELISTOR sNDA
Salix Pharmaceuticals, Ltd. and Progenics Pharmaceuticals announced that they received at approximately 5:00 p.m. ET a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) following its review of a Supplemental New Drug Application (sNDA) for RELISTOR (methylnaltrexone bromide) injection for subcutaneous use for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain. The CRL requests additional clinical data. Salix and Progenics intend to request an End-of-Review meeting with the Division of Gastroenterology and Inborn Errors Products to better understand the contents of the CRL. RELISTOR is a peripherally acting mu–opioid receptor antagonist specifically designed to block the constipating effects of opioid pain medications in the gastrointestinal tract. RELISTOR does not cross the blood-brain barrier, therefore relieving the distressing effects of the constipation while retaining the analgesic effect of the opioid. RELISTOR Subcutaneous Injection has been FDA approved since 2008 to treat constipation in patients with advanced illness and receiving palliative care, when response to laxative therapy has not been sufficient. Full Article
FDA approves Salix's diarrhea drug for HIV/AIDS patients
- U.S. health regulators approved Salix Pharmaceuticals Ltd's drug to treat diarrhea in HIV/AIDS patients on antiretroviral therapy, a combination of medicines used to treat HIV infection.
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