Impax Laboratories, Inc. (NASDAQ: IPXL) today reported second quarter 2012 financial results.
- Adjusted net income increased $28.4 million to $41.0 million in the second quarter 2012, or $0.60 per diluted share, compared to $12.6 million, or $0.19 per diluted share, in the prior year period, primarily attributable to the benefit of the revenue and gross profit earned from United States (U.S.) Zomig® sales pursuant to the previously disclosed License Agreement with AstraZeneca UK Limited (AstraZeneca License Agreement) and higher generic Adderall XR® sales. Adjusted results exclude certain items related to recent third-party business development transactions.
- GAAP net income increased 49% to $18.7 million in the second quarter 2012, or $0.27 per diluted share, compared to $12.6 million, or $0.19 per diluted share, in the prior year period, primarily due to U.S. Zomig® tablet sales by the Company’s brand division and higher generic Adderall XR® sales.
- Total revenues increased 32% to $166.5 million in the second quarter 2012, compared to $125.9 million in the prior year period, primarily due to U.S. Zomig® tablet sales and higher generic Adderall XR® sales. Second quarter 2012 revenues exclude U.S. Zomig® orally disintegrating and nasal spray formulation sales by AstraZeneca, although the Company received the benefit of the gross profit ($16.2 million) from these sales during the specified transition period pursuant to the AstraZeneca License Agreement.
- Adjusted earnings before interest, taxes, depreciation and amortization (Adjusted EBITDA), increased to $72.6 million in the second quarter 2012, compared to $24.9 million in the prior year period, primarily attributable to the items noted above.
Please refer to “Non-GAAP Financial Measures” below for a reconciliation of GAAP to non-GAAP items.
“The positive second quarter results reflect our Zomig® tablets sales in the U.S. utilizing our expanded neurology focused brand sales force, as well as increased receipt of shipments of generic Adderall XR® from our third-party supplier which led to higher sales in the quarter,” said Larry Hsu, Ph.D., president and CEO, Impax Laboratories, Inc. “We are excited that our brand sales force began promoting and sampling Zomig® tablets in the U.S. on April 1. This product will support the growth of our commercial organization as we prepare for the potential launch of Rytary TM, our first internally developed brand product for Parkinson’s Disease.”
“The U.S. Food and Drug Administration (FDA) recently completed a preapproval inspection for Rytary TM and an undisclosed generic product at our Taiwan facility and there were no Form 483 observations. We continue to work at resolving the recent observation made by the FDA in Hayward and have been notified that a satisfactory re-inspection will be necessary to close out the warning letter,” Dr. Hsu continued.“Our generic business pipeline has 46 pending ANDAs with more than 40 internally developed or partnered products, including many alternative dosage form products. We remain focused on pursuing strategic opportunities that are aimed at advancing our generic and brand businesses beyond our internal efforts. So far in 2012, our business development activities include the in-licensing of Zomig® on the brand side, and the acquisition of alternative dosage form generic products and a co-development, supply and distribution agreement with TOLMAR, Inc. on the generics side. With more than $354 million in cash and short-term investments and no debt, our business development activities will continue to focus on delivering growth from high-value products, technologies, and businesses in complementary dosage forms,” Dr. Hsu concluded.