SIGNIFICANT ACCOUNTING POLICIES (Tables)

9 Months Ended

Sep. 30, 2018

Schedule of Error Corrections and Prior Period Adjustments [Table Text Block]

The effects of the restatement on the line items within the Company’s condensed consolidated balance sheets as of September 30, 2018 are as follows:

	September 30, 2018
( U.S. dollars in thousands)	As originally reported			Adjustments			As restated
CONTRACTS ASSET	$	1,450		$	(1,450	)	$	-
CURRENT LIABILITIES:
Contracts liability		-			9,786			9,786
Total current liabilities	$	14,551		$	9,786		$	24,337
LONG TERM LIABILITIES:
Contracts liability		61,780			(28,287	)		33,493
Total long term liabilities		117,640			(28,287	)		89,353
Total liabilities		132,191			(18,501	)		113,690
CAPITAL DEFICIENCY	$	(64,994	)	$	17,051		$	(47,943	)

The effects of the restatement on the line items within the Company’s condensed consolidated statements of operations for the three and nine months ended September 30, 2018 are as follows:

	Three Months Ended September 30, 2018									Nine Months Ended September 30, 2018
( U.S. dollars in thousands, except per share data)	As originally reported			Adjustments			As restated			As originally reported			Adjustments			As restated
REVENUES FROM LICENSE AGREEMENTS	$	-		$	11,672		$	11,672		$	-		$	16,665		$	16,665
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES	$	(2,638	)	$	(1,450	)	$	(4,088	)	$	(7,294	)	$	(1,450	)	$	(8,744	)
OPERATING LOSS	$	(13,963	)	$	10,222		$	(3,741	)	$	(30,851	)	$	15,215		$	(15,636	)
LOSS FOR THE PERIOD	$	(15,544	)	$	10,222		$	(5,322	)	$	(36,238	)	$	15,215		$	(21,023	)
Net loss per share of common stock-basic and diluted	$	(0.10	)	$	0.06		$	(0.04	)	$	(0.25	)	$	0.11		$	(0.14	)

The effects of the restatement on the line items within the Company’s condensed consolidated statements of changes in capital deficiency for the nine months ended September 30, 2018 are as follows:

	Nine Months Ended September 30, 2018
( U.S. dollars in thousands, except per share data)	As originally reported			Adjustments		As restated
Net loss for the nine months ended September 30, 2018	$	(36,238	)	$	15,215	$	(21,023	)
Balances as of September 30, 2018
Accumulated deficit		(334,170	)		17,051		(317,119	)
Total capital deficiency	$	(64,994	)	$	17,051	$	(47,943	)

Although there was with no impact to net cash provided by operating activities, net cash used in investing activities or net cash used in financing activities, the effects of the restatement on the line items within the condensed consolidated statements of cash flows for the nine months ended September 30, 2018 are as follows:

	Nine Months Ended September 30, 2018
( U.S. dollars in thousands)	As originally reported			Adjustments			As restated
Cash flows from operating activities:
Net loss	$	(36,238	)	$	15,215		$	(21,023	)
Increase in contracts liability		34,929			(16,665	)		18,264
Increase in contract asset		(1,450	)		1,450			-
Net cash used in operating activities	$	(3,738	)	$	-		$	(3,738	)

In addition, in connection with the Chiesi Ex-U.S. Agreement, the Company should have recognized $1.8 million of revenue in the last quarter of 2017 and accordingly has revised certain items in its consolidated financial statements for December 31, 2017 presented herein. The Company evaluated the materiality of the error from quantitative and qualitative perspectives, and concluded that the error was immaterial to the Company’s prior annual consolidated financial statements. Since the revision was not material to any prior interim period or annual consolidated financial statements, no amendments to previously filed interim or annual periodic reports was required. Consequently, the Company revised the historical consolidated financial information presented herein. Below are amounts as reported and as adjusted for December 31, 2017:

	December 31, 2017
( U.S. dollars in thousands)	As originally reported			Adjustments			As revised
Contracts liability	$	26,851		$	(1,836	)	$	25,015
Accumulated deficit		(297,932	)		1,836			(296,096	)