Impax Receives FDA Approval for a Generic Version of Lamictal® Orally Disintegrating Tablets (ODT)
Jan 26 15
Impax Laboratories Inc. announced that the U.S. Food and Drug Administration (FDA) has approved generic Lamictal (lamotrigine) Orally Disintegrating Tablets, 25mg, 50mg, 100mg and 200mg in blister packaging. Impax will promptly initiate commercialization of this product through Global Pharmaceuticals, Impax's generic division.
Impax Laboratories Inc. Formally Resolves the Federal Securities Class Action Lawsuit
Jan 14 15
On January 13, 2015, Impax Laboratories Inc., together with certain current and former officers and directors of the company, formally resolved the federal securities class action lawsuit filed against the company and the other defendants in the United States District Court for the Northern District of California, captioned Aruliah v. Impax Laboratories Inc. et al, Case No. 3:14-cv-03673-JD. The settlement provides for the resolution of all the pending claims in the Securities Class Action, without any admission or concession of wrongdoing or liability by the Company or the other defendants. The company and other defendants agreed to the settlement to eliminate the uncertainty, distraction, burden and expense of further litigation. Pursuant to the settlement, the company will pay $4.75 million for a full and complete release of all claims that were or could have been asserted against the Company or other defendants in the Securities Class Action. The company currently expects that the settlement amount will be paid for and covered by the company's insurance policy. The settlement remains subject to preliminary and final court approval and certain other conditions and does not resolve the related shareholder derivative litigations.
Impax Pharmaceuticals Announces FDA Approves RYTARY
Jan 8 15
Impax Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved RYTARY, an extended-release oral capsule formulation of carbidopa-levodopa, for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and /or manganese intoxication. RYTARY is not for use in patients using nonselective monoamine oxidase inhibitors (MAO) inhibitors. RYTARY contains immediate release and extended-release beads, with a specific amount of carbidopa and levodopa in a 1:4 ratio, and provides both initial and extended levodopa plasma concentrations after a single dose. RYTARY may be swallowed whole or, for patients who have trouble swallowing, the capsule may be opened and the beads sprinkled on applesauce and consumed immediately.
Impax Laboratories Inc. Presents at 33rd Annual J.P. Morgan Healthcare Conference, Jan-13-2015 08:30 AM
Jan 6 15
Impax Laboratories Inc. Presents at 33rd Annual J.P. Morgan Healthcare Conference, Jan-13-2015 08:30 AM. Venue: Westin St. Francis Hotel, San Francisco, California, United States. Speakers: George Frederick Wilkinson, Chief Executive Officer, President and Director.
Impax Laboratories, Inc. Announces Consolidated Unaudited Earnings Results for the Third Quarter and Nine Months Ended September 30, 2014; Provides Earnings Guidance for the Year 2014
Nov 4 14
Impax Laboratories Inc. announced consolidated unaudited earnings results for the third quarter and nine months ended September 30, 2014. For the period, the company reported total revenues of $157,999,000 against $132,641,000 a year ago. Income from operations was $25,501,000 against loss from operations of $194,000 a year ago. Income before income taxes was $25,854,000 against $20,000 a year ago. Net income was $15,737,000 against net loss of $180,000 a year ago. Net income per diluted share was $0.22 against $0.00 a year ago. Adjusted net income was $23,396,000 against $16,550,000 a year ago. Adjusted net income per diluted share was $0.33 against $0.25 a year ago. EBITDA was $31,294,000 against $4,993,000 a year ago. Adjusted EBITDA was $48,238,000 against $34,237,000 a year ago. The strong third quarter results were driven by higher sales from key products in the generics business as well as continued growth of Zomig nasal spray in brand division.
For the nine months, the company reported total revenues of $464,838,000 against $410,761,000 a year ago. Income from operations was $87,668,000 against $9,847,000 a year ago. Income before income taxes was $88,909,000 against $162,775,000 a year ago. Net income was $57,233,000 against $110,881,000 a year ago. Net income per diluted share was $0.81 against $1.62 a year ago. Net cash provided by operating activities was $53,939,000 against $155,266,000 a year ago. Purchases of property, plant and equipment was $23,968,000 against $24,222,000 a year ago. Adjusted net income was $23,396,000 against $16,550,000 a year ago. Adjusted net income per diluted share was $1.17 against $0.84 a year ago. EBITDA was $104,847,000 against $178,297,000 a year ago. Adjusted EBITDA was $159,239,000 against $113,782,000 a year ago.
The company announced that full year 2014 estimates are based on management's current belief about prescription trends, pricing levels, inventory levels, and the anticipated timing of future product launches and event, adjusted gross margins as a % of total revenue are expected to be in the upper 50% range. Capital expenditures are to be approximately $35.0 million (previously $40.0 million to $45.0 million) due to changes in the timing and reprioritization of projects. Effective tax rate is to be approximately 34% (previously 32% to 34%) on a GAAP basis due to product sales mix based on jurisdiction.