ARIAD Reports Third Quarter 2016 Financial Results

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported financial results for the third quarter and first nine months of 2016. The Company also provided an update on corporate developments and reaffirmed 2016 financial guidance.

"During the third quarter, ARIAD achieved several important milestones that further our commitment as a small, research-based biotechnology company to patients with rare cancers, including those with no other targeted treatment options available," said Paris Panayiotopoulos, president and chief executive officer of ARIAD. "Iclusig was approved in Japan and we received priority review from the FDA for brigatinib in crizotinib-treated ALK+ non-small cell lung cancer. We are continuing to invest heavily in R&D and to progress in enrolling in the OPTIC, OPTIC-2L and ALTA-1L trials for Iclusig and brigatinib, as well as our clinical trial for AP32788, a novel kinase inhibitor for a rare form of lung cancer involving mutations in the EGFR and HER2 genes, and for which there are currently no approved targeted treatments."

Financial Results for the Quarter and Nine Months Ended September 30, 2016

Revenue
  • Worldwide net product revenue from sales of Iclusig were $34.3 million for the third quarter of 2016, compared to $27.5 million in the third quarter of 2015, an increase of 25%; and $133.3 million for the first nine months of 2016, compared to $79.3 million for the first nine months of 2015, an increase of 68%. Net product revenue for the nine months ended September 30, 2016 includes one-time revenue of approximately $25.5 million related to cumulative shipments of Iclusig in France that were recorded upon obtaining pricing and reimbursement approval in May 2016.
    • U.S. net product revenue from sales of Iclusig were $33.6 million for the third quarter of 2016, compared to $20.3 million in the third quarter of 2015, an increase of 66 percent; and $91.2 million for the first nine months of 2016, compared to $60.6 million for the first nine months of 2015, an increase of 50 percent.
    • European royalties on sales of Iclusig were $4.0 million of which $3.5 million was recorded as other revenue during the third quarter of 2016. European royalties on sales of Iclusig were $5.3 million of which $4.6 million was recorded as other revenue during the first nine months of 2016. On June 1, 2016, ARIAD out-licensed the rights to Iclusig in Europe to Incyte Corporation (Incyte). From June 1, 2016, ARIAD records royalty revenue based on tiered royalty rates from Iclusig sales in Europe recognized by Incyte. European sales of Iclusig were $7.2 million for the third quarter of 2015 and $18.7 million for the first nine months of 2015.
    • For the three and nine months ended September 30, 2016, license and other revenue includes $3.5 million from research and development cost sharing amounts from Incyte and achievement of a $2.0 million milestone from Medinol Ltd. earned during the third quarter of 2016.

GAAP and Non-GAAP Net Income (Loss)

GAAP net loss for the quarter ended September 30, 2016 was $27.8 million, or $0.14 per basic and diluted share, respectively, compared to GAAP net loss of $55.5 million, or $0.29 loss per basic and diluted share, for the quarter ended September 30, 2015. GAAP net income for the nine months ended September 30, 2016 was $28.2 million, or $0.15 per basic share and $0.14 per diluted share, compared to GAAP net loss of $171.3 million, or $0.91 loss per basic and diluted share, for the nine months ended September 30, 2015. During the nine months ended September 30, 2016, the Company recorded a $129.0 million gain related to the Incyte transaction under other income (expense), net related to closing the sale of the Company's European operations and out-license of Iclusig rights in Europe.

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