$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 {{ '2017-12-19T14:14:39+0000' | timeago}} • Announcement

$IPXL agreed to sell its manufacturing facility in Taiwan to Bora Pharmaceuticals. Bora will buy all issued share capital in Impax Taiwan and certain loans outstanding between Impax and Impax Taiwan for $18.5MM. $IPXL expects to record pre-tax impairment charge of about $70-80MM in 4Q17. The deal will close in 1Q18.

$IPXL {{ '2017-12-18T13:05:53+0000' | timeago}} • Announcement

Amneal Pharmaceuticals LLC and $IPXL said Robert Stewart will join Amneal as President, effective Jan. 25, 2018. Stewart most recently served as COO of $AGN. After completion of combination of Amneal and $IPXL, Stewart will become President and CEO of the combined company, to be named Amneal Pharmaceuticals Inc., and will become a BoD member.

$IPXL {{ '2017-12-08T13:54:33+0000' | timeago}} • Announcement

$IPXL has received tentative US FDA  approval on its Abbreviated New Drug Application for a generic version of Coreg CR (carvedilol phosphate) extended-release capsules, 10, 20, 40 and 80 mg. The ANDA is eligible for final approval upon the expiration of marketing exclusivity on May 7, 2018.

$IPXL {{ '2017-10-17T12:55:44+0000' | timeago}} • Announcement

$IPXL has entered into a definitive agreement with Amneal Pharmaceuticals, under which the companies will merge to create the largest generics business in the US. Pursuant to the all-stock transaction, Amneal shareholders will own 75% and Impax shareholders will own 25% of the new company's pro forma shares.

$IPXL {{ '2017-08-07T12:29:03+0000' | timeago}} • Announcement

$IPXL announced a settlement agreement to resolve a contract dispute relating to an agreement entered into in June 2010 among Endo International plc, Penwest Pharmaceuticals and Impax over the new drug application of Opana tablets.

$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.

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