$IPXL (Impax Laboratories Inc.)

$IPXL {{ '2015-11-24T14:55:32+0000' | timeago}} • Announcement

$IPXL said that it has received U.S. FDA's final approval for its generic version of Avodart (Dutasteride) capsules 0.5 mg on Nov. 20, 2015, which is used to treat benign prostatic hyperplasia in men with enlarged prostate. According to IMS Health, U.S. brand & generic sales of Dutasteride were about $457MM for 12 months ended Sept. 2015.

$IPXL {{ '2017-07-17T13:54:20+0000' | timeago}} • Announcement

$IPXL has received final FDA approval on its Abbreviated New Drug Application for a generic version Concerta (methylphenidate hydrochloride) Extended-Release tablets USP CII. The drug is used to treat Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65.

$IPXL {{ '2017-07-05T21:29:14+0000' | timeago}} • Announcement

$IPXL has received final FDA approval on its Abbreviated New Drug Application for a generic version of Focalin XR extended-release capsules CII, 25 and 35 mg. The drug is used in the treatment of ADHD. Impax has immediately initiated commercialization activities.

$IPXL {{ '2017-05-10T14:01:54+0000' | timeago}} • Webcast

$IPXL said that it is working to get the capacity up in Hayward facility and bring products in from some of its outside suppliers or in-house. The company expects to achieve good utilization rate by the end of 2018 or 2019.

$IPXL {{ '2017-05-10T13:49:22+0000' | timeago}} • Webcast

$IPXL stated that it would look for acquiring assets in both specialty and generic businesses. Also, $IPXL added that it will look for partnerships with private companies, which want to partner with it in developing and building a bigger organization. The company has some capacity, but doesn't have the capacity to do a large deal.

$IPXL {{ '2017-05-10T13:22:41+0000' | timeago}} • Webcast

Commenting on the macro environment, $IPXL stated that the consolidation of the purchasers has created some challenges in the generic side. The company expects consolidation to continue in the industry. $IPXL added that it focuses on building its franchise on generics and specialty business.

$IPXL {{ '2017-05-10T11:41:32+0000' | timeago}} • Announcement

$IPXL now sees FY17 adjusted EPS at $0.55-0.70, with an effective tax rate of 33-34%. Adjusted interest expense for the year is touted to be approximately $28MM, with capex estimated at $25-30MM.

$IPXL {{ '2017-05-10T11:38:55+0000' | timeago}} • Announcement

The restructuring activities, which $IPXL announced while posting 1Q17 results, is seen to produce annual cost savings of $85.0MM, with a limited amount of savings in 2017. Impax will incur one-time cash charges of up to about $65.0MM to fully achieve these new initiatives.

$IPXL {{ '2017-05-10T11:36:40+0000' | timeago}} • Announcement

As $IPXL posted 1Q17 results, it said it is reviewing strategic alternatives for the Taiwan manufacturing site including a sale or closure of the facility. Impax also plans to consolidate all of generic R&D, U.S. manufacturing, and packing operations to its Hayward, CA facility, and close the Middlesex generic R&D site.

$IPXL {{ '2017-05-10T11:32:21+0000' | timeago}} • Announcement

Total revenues for $IPXL fell 18.2% in 1Q17 to $184.4MM, with the specialty pharma firm posting an almost ten-fold rise in net loss of $98.4MM or $1.37 per diluted share from last year's $10.4MM or $0.15 a share loss. The bloating losses were due to $45.4MM in intangible asset impairment charges and $30.9MM in income tax provision for the quarter.

$IPXL {{ '2017-03-31T10:43:08+0000' | timeago}} • Announcement

U.S. District Court of Delaware ruled in favor of $IPXL as they found that the U.S. patents 6,750,237 and 7,220,767 protecting the zolmitriptan nasal spray are not invalid and are infringed by the defendants Lannett Holdings, Inc. and $LCI.

$IPXL {{ '2017-03-27T14:15:56+0000' | timeago}} • Announcement

$IPXL BoD appointed Paul Bisaro as its President and CEO and a member of the company's Board, effective March 27, 2017. Bisaro will succeed Kevin Buchi, who has served as Interim President and CEO since Dec. of 2016.

$CVS {{ '2017-01-12T15:14:53+0000' | timeago}} • Announcement

$CVS offers patients low-cost epinephrine auto-injector option, the authorized generic for Adrenaclick manufactured by $IPXL, to treat allergic reactions. The product is available at $CVS Pharmacy at cash price 80% lower than EpiPen.

$IPXL {{ '2016-12-20T14:02:53+0000' | timeago}} • Webcast

$IPXL said it appointed J. Kevin Buchi, a Board Member as its Interim President and CEO, following the departure of G. Frederick Wilkinson, effective immediately.

$IPXL {{ '2016-11-28T13:20:57+0000' | timeago}} • Announcement

$IPXL said J. Kevin Buchi was appointed to its BoD on November 23. Mr. Buchi currently serves as President, CEO and a member of the board of directors of TetraLogic Pharmaceuticals Corporation.

$IPXL {{ '2016-09-22T14:34:41+0000' | timeago}} • Announcement

Specialty pharmaceutical company $IPXL said that it launched a generic version of Metadate CD, a drug or central nervous system (CNS) stimulant which is used to treat attention deficit disorder. This is the company's sixth new product launch since the beginning of 2016.

$IPXL {{ '2016-08-22T12:23:49+0000' | timeago}} • Announcement

Specialty pharmaceutical company $IPXL said Richard Bierly, most recently the CFO of $MDVN, was appointed to the company's BoD on Aug. 19 and will also serve on the Board's Audit Committee. Bierly currently serves as a director on the BoD and as Chairman of the Audit Committee of $ACRS.

$IPXL {{ '2016-04-13T11:47:32+0000' | timeago}} • Announcement

$IPXL said its EMVERM (mebendazole) 100 mg chewable tablets are now available for healthcare providers to prescribe to patients in the United States. EMVERM is indicated for the treatment of various worm infections.

$IPXL {{ '2016-02-17T12:52:15+0000' | timeago}} • Announcement

Specialty pharmaceutical company $IPXL said that the FDA has granted approval for its Abbreviated New Drug Application (ANDA) for Adderall XR (mixed salts of a single-entity amphetamine product) extended-release capsules, which are used for the treatment of attention deficit hyperactivity disorder (ADHD).

$IPXL {{ '2016-02-02T16:40:36+0000' | timeago}} • Announcement

$IPXL said it received tentative approval from the U.S. FDA for its Abbreviated New Drug Application for the generic version of cholesterol drugs ezetimibe and simvastatin containing tablets, in 10 mg / 10 mg, 10 mg / 20 mg, 10 mg / 40 mg and 10 mg / 80 mg strengths.

$IPXL {{ '2016-01-15T14:32:11+0000' | timeago}} • Announcement

Specialty pharmaceutical firm $IPXL said the U.S. FDA has approved supplemental new drug application (sNDA) for Emverm (mebendazole) 100 mg chewable tablets. Emverm is indicated for treatment of pinworm, whipworm, common roundworm, common hookworm, American hookworm in single or mixed infections. $IPXL will start distribution early in 2Q16.

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