Hayward, CA, United States
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News Article | June 8, 2017
Site: www.prnewswire.com

HAYWARD, Calif., June 8, 2017 /PRNewswire/ -- Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the Company will present at the Goldman Sachs 38th Annual Global Healthcare Conference in Rancho Palos Verdes, CA on Tuesday, June 13 at 2:40 p.m. Pacific Time (5:40 p.m. Eastern Time). Individuals may listen to the live or an archived presentation made at the conference, which will be posted in the investor relations section of the Company's web site at www.impaxlabs.com.  This presentation will be archived on the Company's web site for 90 days.


Patent
Impax Laboratories | Date: 2016-12-19

The current invention provides a controlled release oral solid formulation of levodopa comprising levodopa, a decarboxylase inhibitor, and a carboxylic acid. Also provided by this invention is multiparticulate, controlled release oral solid formulations of levodopa comprising: i) a controlled release component comprising a mixture of levodopa, a decarboxylase inhibitor and a rate controlling excipient; ii) a carboxylic acid component; and iii) an immediate release component comprising a mixture of levodopa and a decarboxylase inhibitor.


News Article | May 11, 2017
Site: www.prnewswire.com

HAYWARD, Calif., May 11, 2017 /PRNewswire/ -- Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that Paul Bisaro, President and Chief Executive Officer, and Bryan Reasons, Senior Vice President and Chief Financial Officer, will participate in a fireside chat at the Bank of America Merrill Lynch Healthcare Conference in Las Vegas on Thursday, May 18, 2017 at 10:00 a.m. Pacific Time (1:00 p.m. Eastern Time). Individuals may listen to the live or an archived presentation made at the conference, which will be posted in the investor relations section of the Company's web site at www.impaxlabs.com.  This presentation will be archived on the Company's web site for 90 days.


News Article | May 10, 2017
Site: www.prnewswire.com

GAAP net loss and GAAP net loss per diluted share were $98.4 million and $1.37, respectively, in the first quarter 2017, compared to a loss of $10.4 million and $0.15, respectively, in the prior year period. The first quarter 2017 net loss was primarily driven by $45.4 million in intangible asset impairment charges, for which there were no comparable charges during the prior year period, as well as a $30.9 million income tax provision on the current period net loss. The Company could not record a tax benefit on the current quarter loss and revalued its previously recorded deferred tax assets in accordance with U.S. GAAP. Adjusted net income and adjusted net income per diluted share were $7.7 million and $0.11, respectively, in the first quarter 2017, compared to $30.9 million and $0.43, respectively, in the prior year period. Refer to the attached "Non-GAAP Financial Measures" for a reconciliation of all GAAP to non-GAAP items. "While our first quarter results reflect a challenging macro environment, Impax continues to have a number of strong performing products and R&D opportunities within our portfolio," said Paul Bisaro, President and Chief Executive Officer of Impax. "Since I joined the Company in March, we have carefully evaluated how best to improve profitability and capitalize on Impax's growth opportunities in both our generics and our specialty businesses. As a result of this work, we have made the decision to consolidate Impax's Generic R&D, manufacturing and packaging operations in Hayward, which will allow us to achieve operating efficiencies, improve manufacturing utilization, reduce costs and facilitate sharing of best practices." Mr. Bisaro continued, "While our operating footprint is consolidating, we remain committed to growing our generics and specialty brand franchises by investing in both internal and external development opportunities. We believe that the actions we are announcing today will place us in an even better position to advance these strategic objectives with the intent to create long-term shareholder value." The Company has initiated a series of actions that are designed to improve manufacturing and R&D efficiencies, capitalize on growth opportunities, improve profitability and mitigate current challenges. The actions include: By consolidating activities as outlined above, the Company expects to achieve cost savings and operating efficiency benefits, while maintaining the infrastructure and expertise needed to capitalize on product and pipeline strengths. The Company expects these actions to produce annual cost savings of approximately $85.0 million, with a limited amount of savings in 2017. The Company will incur one-time cash charges of up to approximately $65.0 million to fully achieve these new initiatives. The combination of these new initiatives and the Company's previously announced initiatives are projected to result in total annualized cost savings of approximately $130.0 million, with the goal for all savings to be fully captured by the end of 2019. The timing to incur one-time cash charges and to achieve the total annual cost savings is dependent on the execution of the strategic alternatives relating to the Taiwan site. The Company has two reportable segments, the Impax Generics division (generic products and services) and the Impax Specialty Pharma division (brand products and services) and does not allocate general corporate services to either segment. All information presented is on a GAAP basis unless otherwise noted. Total revenues for the Impax Generics division in the first quarter 2017 were $134.1 million, a decrease of 21.1%, compared to the prior year period. The decrease was primarily due to increased competition on diclofenac sodium gel, metaxalone, mixed amphetamine salts ER and fenofibrate. These decreases were partially offset by increased sales of epinephrine auto-injector, oxymorphone ER and the products acquired as part of the Teva Transaction. Gross margin in the first quarter 2017 was negative 6.3%, compared to gross margin of 35.3% in the prior year period, driven largely by impairment charges of $39.3 million recognized in the current year period and primarily attributable to two products acquired as part of the Teva Transaction, for which there were no comparable charges in the prior year period. Adjusted gross margin in the first quarter 2017 was 38.8%, compared to 39.3% in the prior year period. Total operating expenses in the first quarter 2017 were $30.3 million, compared to $19.5 million in the prior year period, partially due to higher selling, general and administrative expenses and increased research and development costs. In addition, the Company recorded an IPR&D impairment charge of $6.1 million in the first quarter 2017 as a result of expected increased research and development expenses and a delay in an anticipated product launch due to a change in the regulatory strategy to secure FDA approval on a product acquired as part of the Teva Transaction, for which there was no comparable charge in the prior year period. Total revenues for the Impax Specialty Pharma division in the first quarter 2017 were $50.3 million, a decrease of 9.3%, compared to the prior year period, as higher sales of Rytary were more than offset by lower sales of Zomig and the anthelmintic products franchise. Gross margin in the first quarter 2017 was 66.4%, compared to 76.9% in the prior year period. Adjusted gross margin in the first quarter 2017 was 74.0%, compared to 83.5% in the prior year period, primarily due to product sales mix. Total operating expenses in the first quarter 2017 were $22.1 million, compared to $19.5 million in the prior year period, primarily due to higher advertising and promotion costs related to Rytary and higher costs related to the sales force expansion. General and administrative expenses in the first quarter 2017 were $24.3 million, a decrease of 5.6% compared to the prior year period, primarily due to lower expenses related to lower IT and business development spending and the absence of a permanent President and Chief Executive Officer prior to Mr. Bisaro's appointment, effective March 27, 2017. Interest expense in the first quarter 2017 was $13.4 million, an increase of $5.0 million compared to the prior year period, due to the $400.0 million Term Loan Facility entered into by the Company in the third quarter 2016 to finance the Teva Transaction. During the first quarter 2017, the Company recorded a $30.9 million income tax provision on the current period loss before taxes, compared to a $7.1 million benefit from income taxes recognized on the prior year period loss before taxes.  Due to the Company's cumulative loss over the three year period ended March 31, 2017, no current tax benefit can be recorded on the Company's first quarter loss before taxes. In addition, the Company revalued its deferred tax assets in a new reporting period in accordance with U.S. GAAP. The Company's full year 2017 financial guidance has been updated as of May 10, 2017, as noted below. The Company's full year 2017 estimates are based on management's current expectations, including with respect to prescription trends, pricing levels, inventory levels, and the anticipated timing of future product launches and events.  The estimates exclude the cost savings and one-time charges from the new cost savings initiatives of $85.0 million as outlined in the Consolidation and Improvement Plan, described above. The Company does not provide forward-looking guidance metrics as outlined below on a GAAP basis as certain financial information, such as restructuring and impairment charges and other items used to determine such measures are not available and cannot be reasonably estimated. The following statements are forward looking and actual results could differ materially depending on market conditions and the factors set forth under "Safe Harbor" below. The Company will host a conference call with a slide presentation on May 10, 2017 at 8:30 a.m. ET to discuss its results. The call and presentation can also be accessed via a live Webcast through the Investor Relations section of the Company's Web site, www.impaxlabs.com. The number to call from within the United States is (877) 356-3814 and (706) 758-0033 internationally. The conference ID is 4770253. A replay of the conference call will be available shortly after the call for a period of seven days. To access the replay, dial (855) 859-2056 (in the U.S.) and (404) 537-3406 (international callers). Impax Laboratories, Inc. (Impax) is a specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of central nervous system disorder branded products. Impax markets its generic products through its Impax Generics division and markets its branded products through the Impax Specialty Pharma division. Additionally, where strategically appropriate, Impax develops marketing partnerships to fully leverage its technology platform and pursues partnership opportunities that offer alternative dosage form technologies, such as injectables, nasal sprays, inhalers, patches, creams, and ointments. For more information, please visit the Company's Web site at: www.impaxlabs.com. "Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995: To the extent any statements made in this news release contain information that is not historical; these statements are forward-looking in nature and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause the Company's future results, performance, or achievements to differ significantly from the results, performance, or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to: fluctuations in the Company's operating results and financial condition; the volatility of the market price of the Company's common stock; the Company's ability to successfully develop and commercialize pharmaceutical products in a timely manner; the impact of competition; the effect of any manufacturing or quality control problems;  the Company's ability to manage its growth; risks related to acquisitions of or investments in technologies, products or businesses; risks relating to goodwill and intangibles; the reduction or loss of business with any significant customer; the substantial portion of the Company's total revenues derived from sales of a limited number of products; the impact of consolidation of the Company's customer base; the Company's ability to sustain profitability and positive cash flows; the impact of any valuation allowance on the Company's deferred tax assets; the restrictions imposed by the Company's credit facility and indenture; the Company's level of indebtedness and liabilities and the potential impact on cash flow available for operations; the availability of additional funds in the future; any delays or unanticipated expenses in connection with the operation of the Company's manufacturing facilities; the effect of foreign economic, political, legal and other risks on the Company's operations abroad; the uncertainty of patent litigation and other legal proceedings; the increased government scrutiny on the Company's agreements to settle patent litigations, product development risks and the difficulty of predicting FDA filings and approvals; consumer acceptance and demand for new pharmaceutical products; the impact of market perceptions of the Company and the safety and quality of the Company's products; the Company's determinations to discontinue the manufacture and distribution of certain products; the Company's ability to achieve returns on its investments in research and development activities; changes to FDA approval requirements; the Company's ability to successfully conduct clinical trials; the Company's reliance on third parties to conduct clinical trials and testing; the Company's lack of a license partner for commercialization of Numient® (IPX066) outside of the United States; impact of illegal distribution and sale by third parties of counterfeits or stolen products; the availability of raw materials and impact of interruptions in the Company's supply chain; the Company's policies regarding returns, rebates, allowances and chargebacks; the use of controlled substances in the Company's products; the effect of current economic conditions on the Company's industry, business, results of operations and financial condition; disruptions or failures in the Company's information technology systems and network infrastructure caused by third party breaches or other events; the Company's reliance on alliance and collaboration agreements; the Company's reliance on licenses to proprietary technologies; the Company's dependence on certain employees; the Company's ability to comply with legal and regulatory requirements governing the healthcare industry; the regulatory environment; the effect of certain provisions in the Company's government contracts; the Company's ability to protect its intellectual property; exposure to product liability claims; changes in tax regulations; uncertainties involved in the preparation of the Company's financial statements; the Company's ability to maintain an effective system of internal control over financial reporting; the effect of terrorist attacks on the Company's business; the location of the Company's manufacturing and research and development facilities near earthquake fault lines; expansion of social media platforms and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission.  Forward-looking statements speak only as to the date on which they are made, and the Company undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/impax-reports-first-quarter-2017-financial-results-300454864.html


The invention provides a controlled release oral solid formulation comprising (a) a controlled release component comprising core comprising levodopa and/or an ester of levodopa or salts thereof, wherein the core is coated with a layer of a muco-adhesive polymer and externally coated with a layer of an enteric coated polymer; and (b) a decarboxylase inhibitor component.


The invention provides a controlled release oral solid formulation comprising (a) a controlled release component comprising core comprising levodopa and/or an ester of levodopa or salts thereof, wherein the core is coated with a layer of a muco-adhesive polymer and externally coated with a layer of an enteric coated polymer, and (b) a decarboxylase inhibitor component.


Patent
Impax Laboratories | Date: 2012-02-06

The current invention provides a controlled release oral solid formulation of levodopa comprising levodopa, a decarboxylase inhibitor, and a carboxylic acid. Also provided by this invention is multiparticulate, controlled release oral solid formulations of levodopa comprising: i) a controlled release component comprising a mixture of levodopa, a decarboxylase inhibitor and a rate controlling excipient; ii) a carboxylic acid component; and iii) an immediate release component comprising a mixture of levodopa and a decarboxylase inhibitor.


Patent
Impax Laboratories | Date: 2015-12-04

The current invention provides a controlled release oral solid formulation of levodopa comprising levodopa, a decarboxylase inhibitor, and a carboxylic acid. Also provided by this invention is multiparticulate, controlled release oral solid formulations of levodopa comprising: i) a controlled release component comprising a mixture of levodopa, a decarboxylase inhibitor and a rate controlling excipient; ii) a carboxylic acid component; and iii) an immediate release component comprising a mixture of levodopa and a decarboxylase inhibitor.


Patent
Impax Laboratories | Date: 2014-11-10

The invention relates to a rapidly disintegrating oral dosage form that contains a drug/polymer solid solution and methods of using the oral dosage form.


The present invention relates to dosage forms of a combination of carbidopa and levodopa comprising both immediate release and controlled release components for the treatment of ailments associated with depleted amounts of dopamine in a patients brain tissue.

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