During 2012, Paladin advanced its product pipeline with the in-licensing and launch of new products. Oralair®, a sublingual grass pollen immunotherapy tablet for the treatment of symptoms of moderate to severe seasonal grass pollen allergic rhinitis with or without conjunctivitis, obtained regulatory approval and was subsequently launched during the fourth quarter. Furthermore, Paladin obtained approval for Silenor® (doxepin) for the treatment and symptomatic relief of insomnia. Paladin expects to launch Silenor® in the first half of 2013. In addition, Paladin in-licensed MOXDUO®, a novel, patented, immediate release, fixed dose formulation of morphine and oxycodone for the treatment of acute pain. Paladin expects to submit MOXDUO® for regulatory approval in the first half of 2013.
During 2012, Paladin enhanced its OTC portfolio with the regulatory approval and in-licensing of new products. Paladin in-licensed and obtained approval for AmnioSense , a novel diagnostic test for the detection of amniotic fluid leakage during pregnancy, and VagiSense, which is used to detect bacterial vaginosis or trichomonas infections. Both products are expected to launch in the first half of 2013. In addition, Paladin in-licensed two new OTC products for Canada: Dynamiclear Rapid, for the symptomatic treatment of cold sores, and Emtrix, for the treatment of fingernail and toenail fungal infections. Emtrix is approved for sale in Canada and Dynamiclear Rapid is expected to be submitted for regulatory approval in the first half of 2013.
On February 21, 2012, the Company entered into a strategic partnership whereby it agreed to accelerate the purchase of the remaining 55.01% interest in Pharmaplan it did not own at that date and to merge the Pharmaplan business with the pharma division of Litha. On July 2, 2012, the Company closed these transactions effectively owning a 44.54% interest in Litha.
In November 2012, Paladin initiated the launch of commercial operations in Latin America with the acquisition of a controlling stake of 50.01% in Ativa Pharma S.A., a Mexico City based start up specialty pharma company. The investment in Ativa provides Paladin with the management team, infrastructure and the necessary regulatory permits to import, distribute and promote pharmaceuticals in the Mexican market. Ativa is currently focusing its activities on the registration of various products for regulatory approvals and it is expected that the Ativa's first commercial launches will occur in 2014.
For fiscal 2013, Paladin expects to generate at least $255 million and $190 million in consolidated revenue and adjusted2 revenue respectively of which $115 million and $50 million is attributable to the consolidation of Litha. This forecast excludes the impact of acquisitions and of product launches resulting from new regulatory approvals that may be made by the Company between now and the end of 2013.
(1) EBITDA - Non-IFRS Financial Measures
The term EBITDA (earnings before interest, taxes, depreciation and amortization) does not have any standardized meaning under International Financial Reporting Standards ("IFRS") and therefore may not be comparable to similar measures presented by other companies. The Company defines EBITDA as earnings before interest expense, other expense (income), taxes, depreciation and amortization, foreign exchange gains (losses), share of net income (loss) in associates and joint venture and unusual items; such as write-downs and gains (losses) on intellectual property and investments. EBITDA is calculated and presented consistently from period to period and agrees, on a consolidated basis, with the amount disclosed as "Earnings before under-noted items" on the consolidated statements of income. The Company believes EBITDA to be an important measurement that allows it to assess the operating performance of its ongoing business on a consistent basis without the impact of amortization expenses. The Company excludes amortization expenses because their level depends substantially on non-operating factors such as the historical cost of intangible assets. The Company's method for calculating EBITDA may differ from that used by other issuers and, accordingly, this measure may not be comparable to EBITDA used by other issuers.
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