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Wed, Aug. 6, 10:31 AM
- Impax Laboratories (IPXL +1.3%) Q2 results: Revenues: $188.1M (+45.1%); Gross Profit: $109.8M (+86.4%); Operating Expenses: $55.8M (+5.1%); Operating Income: $53.9M (+829.3%); Net Income: $35.1M (+526.8%); EPS: $0.50 (+525.0%); Quick Assets: $413.0M; CF Ops: $12.4M (-92.7%).
- 2014 Guidance: Adjusted gross margins: upper 50% range versus mid-50% range; R&D expenses: $82M - 88M; SG&A expenses: $115M - 120M; CAPEX: $40M - 45M.
Wed, Aug. 6, 7:31 AM
Tue, Aug. 5, 5:30 PM
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Mon, Aug. 4, 8:47 AM
- The FDA reinspected Impax Laboratories' (NASDAQ:IPXL) Hayward, California manufacturing facility from June 16 to July 31, 2014. In its Form 483, it cited seven observations, two of which were repeat observations. When inspectors note a deficiency for a second time, it usually precipitates a warning letter.
- Impax shares were smacked down on July 29 after regulators inspected its Taiwan manufacturing facility and cited numerous GMP deficiencies.
Tue, Jul. 29, 3:53 PM
- Shares of Impax Laboratories (IPXL -14.6%) plunge on a 7x surge in volume after an FDA inspection of its Taiwan manufacturing facility. The site makes 12 products for U.S. distribution and will produce Ryatary, the firm's drug candidate for Parkinson's disease.
- The inspection notes contain numerous references to GMP violations. Investors perceive that the deficiencies could jeopardize the company's product supply.
Tue, Jul. 29, 12:47 PM
Mon, May. 5, 4:46 PM
- The U.S. District Court for the District of Delaware rules in favor of Avanir Pharmaceuticals (AVNR +1.5%) in its patent infringement case against Par Pharmaceuticals and Impax Laboratories (IPXL -1.3%) regarding their ANDAs for generic versions of Nuedexta.
- The judge upheld the validity of patents '282 and '484 and ruled the proposed formulations infringe on both of them.
- Nuedexta is the only FDA-approved product for the treatment of pseudobulbar effect. Based on the court's decision, the product has 12 years of market exclusivity remaining.
Thu, May. 1, 4:28 PM
Wed, Apr. 30, 5:35 PM
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Mon, Apr. 21, 5:24 PM
Wed, Apr. 16, 9:46 AM
- Impax Laboratories' (IPXL) +1.8%) Global Pharamaeuticals division launches its generic version of Genzyme's (SNY +0.2%) Renvela (sevelamer carbonate).
- The company will sell a specific allotment of bottles granted under a license from Genzyme. Impax's aNDA for the product is currently under regulatory review.
- The U.S. Renvela market is ~$900M.
Fri, Apr. 11, 7:46 AM
- Impax Pharmaceuticals (IPXL) resubmits its NDA for RYTARY (IPX066), an extended release formulation of carbidopa and levodopa for the treatment of Parkinson's disease. The resubmission includes updated information on the product's safety and stability.
- The FDA sent the company a CRL in January citing the need to re-inspect its manufacturing facility subsequent to a May 2011 warning letter.
- Consensus estimates for Q1 and Q2 are earnings of $0.04/share on revenues of $108.7M and earnings of $0.26/share on revenues of $145.5M, respectively.
- Consensus views for 2014 and 2015 are earnings of $0.68/share on revenues of $536.5M and $0.88/share on revenues of $566.5M, respectively.
- 350 mutual funds have positions, up from 315 a year ago.
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Tue, Jan. 7, 1:22 PM
- Impax Labs (IPXL -1.7%) and DURECT (DRRX +5.6%) announce a development and commercialization agreement for the PHN patch, Eladur.
- IPXL is paying $2M upfront for exclusive worldwide rights.
- Additional payments could reach $61M depending upon "the achievement of predefined development and commercialization milestones."
- DRRX also gets royalties assuming the patch reaches the market.
- IPXL is controlling and funding development. (PR)
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IPXL vs. ETF Alternatives
Impax Laboratories, Inc., is a technology-based, specialty pharmaceutical company focused on the development and commercialization of bioequivalent and brand-name pharmaceuticals, utilizing its controlled-release and other in-house development.
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