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1005229_18_item7_p44_s2
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1005229_17_item7_p39_s3
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The decrease in non-current liabilities was primarily due to $5,936,000 in contributions made to our pension plans.
|
The decrease in non-current liabilities was primarily due to $11,211,000 in contributions made to our pension plans.
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1005229_18_item7_p45_s2
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1005229_17_item7_p39_s3
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The decrease in non-current liabilities was primarily due to $5,936,000 in contributions made to our pension plans.
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The decrease in non-current liabilities was primarily due to $6,140,000 in contributions made to our pension plans, excluding the effects of acquisitions.
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1005229_18_item7_p47_s0
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1005229_17_item7_p41_s0
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The most significant use of cash for investing activities in fiscal 2016 relates to our acquisition of Magnetek which totaled $182,467,000 , net of cash acquired.
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The most significant use of cash for investing activities in fiscal 2017 relates to our acquisition of STAHL which totaled $218,846,000 , net of cash acquired.
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1005229_18_item7_p69_s3
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1005229_17_item7_p58_s3
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The later amount is recorded within the current portion of long term debt on the Company's condensed consolidated balance sheet with the remaining balance recorded as long-term debt.
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$64,000 of the capital lease liability has been recorded within the current portion of long term debt on the Company's consolidated balance sheet with the remaining balance recorded as long term debt.
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1005229_18_item7_p64_s3
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1005229_17_item7_p63_s3
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$510,000 of the capital lease liability has been recorded within the current portion of long term debt on the Company's condensed consolidated balance sheet with the remaining balance recorded as long term debt.
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This amount has been recorded within the current portion of long term debt on the Company's consolidated balance sheet with the remaining balance recorded as long-term debt.
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1005229_18_item7_p89_s1
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1005229_17_item7_p83_s1
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If, after completing this assessment, it is determined that it is more likely than not that the fair value of a reporting unit is less than its carrying value, we proceed to a two-step impairment test.
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If, after completing this assessment, it is determined that it is more likely than not that the fair value of a reporting unit is less than its carrying value, we proceed to a quantitative impairment test.
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1005229_18_item7_p91_s1
|
1005229_17_item7_p83_s1
|
If, after completing this assessment, it is determined that it is more likely than not that the fair value of a reporting unit is less than its carrying value, we proceed to a two-step impairment test.
|
If, after completing this assessment, it is determined that it is more likely than not that the fair value of an indefinite-lived intangible asset is less than its carrying value, we proceed to a quantitative impairment test.
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1005229_18_item7_p89_s2
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1005229_17_item7_p83_s2
|
We also proceed to the two-step model when economic or other business factors indicate that the fair value of our reporting units may have declined since our last quantitative test.
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We also proceed to the quantitative model when economic or other business factors indicate that the fair value of our reporting units may have declined since our last quantitative test.
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1005229_18_item7_p8_s0
|
1005229_17_item7_p8_s0
|
From a strategic perspective, we are investing in global markets and new products as we focus on our greatest opportunities for growth.
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From a strategic perspective, we are leveraging our recent acquisitions and investing in new products as we focus on our greatest opportunities for growth.
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1005229_18_item7_p92_s0
|
1005229_17_item7_p91_s0
|
The methodology used to value trademarks is the relief from royalty method.
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The methodology used to value the Magnetek indefinite-lived trademark is the relief from royalty method.
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1006281_12_item7_p34_s0
|
1006281_11_item7_p13_s0
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Our significant accounting policies are more fully described in Note 1 to our consolidated financial statements appearing at the end of this Annual Report.
|
Our significant accounting policies are more fully described in Note 1 to our consolidated financial statements appearing at the end of this Annual Report on Form 10-K. We believe that the accounting policies below are critical for one to fully understand and evaluate our financial condition and results of operations.
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1006281_12_item7_p34_s0
|
1006281_11_item7_p13_s1
|
We believe that the accounting policies below are critical for one to fully understand and evaluate our financial condition and results of operations.
|
Our significant accounting policies are more fully described in Note 1 to our consolidated financial statements appearing at the end of this Annual Report on Form 10-K. We believe that the accounting policies below are critical for one to fully understand and evaluate our financial condition and results of operations.
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1006281_12_item7_p65_s0
|
1006281_11_item7_p45_s0
|
We recorded $4.6 million of income as our share in the collaboration under the Pfizer Agreement during the year ended December 31, 2010.
|
We recorded $5.4 million of loss as our share in the collaboration under the Pfizer Agreement during the year ended December 31, 2011, a decrease of $10.0 million, or 217%, compared to the $4.6 million of income recorded for the year ended December 31, 2010.
| 2 |
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1006281_12_item7_p70_s0
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1006281_11_item7_p48_s0
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We expect research and development expenses to continue to be our primary expense as we enter into a more advanced stage of preclinical trials for certain of our product candidates and into clinical trials for PRX-102, our product candidate for the treatment of Fabry disease, our acetylcholinesterase product candidate and our antiTNF product candidate.
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We expect research and development expenses to continue to be our primary expense as we enter into a more advanced stage of preclinical and clinical trials for certain of our product candidates .
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1006281_12_item7_p79_s1
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1006281_11_item7_p58_s0
|
ordinary shares of Protalix Ltd., and an additional $14.1 million in connection with the exercise of warrants issued in connection with the sale of such ordinary shares, through December 31, 2008.
|
To date, we have funded our operations primarily with proceeds equal to $31.3 million from the sale of convertible preferred and ordinary shares of Protalix Ltd., and an additional $14.1 million in connection with the exercise of warrants issued in connection with the sale of such shares, through December 31, 2008.
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1006281_12_item7_p86_s3
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1006281_11_item7_p58_s4
|
We are also entitled to payments equal to 40% of the net profits earned by Pfizer on its sales of taliglucerase alfa, if any.
|
Protalix Ltd. is also entitled to payments equal to 40% of the net profits earned by Pfizer on its sales of taliglucerase alfa.
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1006281_12_item7_p87_s0
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1006281_11_item7_p59_s0
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In calculating net profits there are certain agreed upon limits on the amounts that may be deducted from gross sales for certain expenses and costs of goods sold.
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In calculat ing net profits there are certain agreed upon limits on the amounts that may be deducted from gross sales for certain expenses and costs of goods sold.
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1006281_12_item7_p92_s0
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1006281_11_item7_p72_s0
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We believe that our existing cash and cash equivalents and the regulatory milestone payments we anticipate receiving from Pfizer will be sufficient to enable us to fund our operating expenses and capital expenditure requirements at least for the next 12 months.
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We believe that our existing cash and cash equivalents and the net proceeds from our public underwritten offering of February 2012 will be sufficient to enable us to fund our operating expenses and capital expenditure requirements at least for the next 12 months.
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1006281_12_item7_p96_s1
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1006281_11_item7_p75_s1
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We do not believe that inflation has had a material effect on our results of operations during the years ended December 31, 2008, 2009 or 2010.
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We do not believe currency fluctuations have had a material effect on our results of operations during the years ended December 31, 2009, 2010 or 2011.
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1006281_12_item7_p95_s1
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1006281_11_item7_p76_s1
|
We do not believe currency fluctuations have had a material effect on our results of operations during the years ended December 31, 2008, 2009 or 2010.
|
We do not believe that inflation has had a material effect on our results of operations during the years ended December 31, 2009, 2010 or 2011.
| 2 |
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1006281_12_item7_p26_s0
|
1006281_11_item7_p8_s2
|
In March 2010, we initiated a preliminary phase I clinical trial of PRX-105, our plant cell expressed pegylated recombinant acetylcholinesterase product candidate for biodefense indications, which we completed in June 2010.
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In March 2010, we initiated a preliminary phase I clinical trial of PRX-105 which we completed in June 2010.
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1006281_12_item7_p26_s1
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1006281_11_item7_p8_s3
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We are currently preparing for further efficacy trials of this product candidate in larger animals and with live nerve gas.
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We are currently preparing for further efficacy trials of this product candidate in larger animals.
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1006281_13_item7_p10_s1
|
1006281_12_item7_p11_s1
|
Eligible patients who successfully completed nine months of treatment in our phase III clinical trial were offered the opportunity to participate in the extension study and continue to receive taliglucerase alfa at the same dose they received in the phase III clinical trial for an additional 15 months in a blinded manner.
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The patients were offered the opportunity to continue to receive taliglucerase alfa at the same dose they received in the pivotal trial for an additional 15 months in a blinded manner.
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1006281_13_item7_p11_s1
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1006281_12_item7_p16_s0
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Although taliglucerase alfa has not yet been approved for commercial sale, patients are being treated with taliglucerase alfa, both in the framework of our clinical trials and related studies and in compassionate use programs, special access agreements, named patient provisions and other programs designed to make sure that treatments are available to Gaucher patients in light of recent shortages of approved treatments.
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Globally, patients are being treated through our extension trials and related studies, compassionate use programs, special access agreements, named patient provisions and other programs designed to ensure that treatments are available to Gaucher patients in light of recent shortages of approved treatments.
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1006281_13_item7_p13_s2
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1006281_12_item7_p21_s3
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In addition, we and the Ministry of Health of Brazil are in discussions relating to a possible long-term supply agreement that contemplates, among other matters, providing certain components of our manufacturing technology to the Ministry of Health of Brazil for implementation by it in Brazil.
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In addition, we and the Brazilian MOH are in discussions relating to a possible long-term supply agreement that contemplates, among other matters, providing certain components of our manufacturing technology to the Brazilian MOH for implementation by it in Brazil.
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1006281_13_item7_p14_s2
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1006281_12_item7_p25_s2
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We participated in a pre IND meeting with respect to one of the undisclosed product candidates in the first quarter of 2012 and a pre IND meeting for the second candidate is planned for later this year.
|
We participated in a pre-investigational new drug, or IND, meeting with respect to one of the undisclosed product candidates in the first quarter of 2012 and a pre-IND meeting for the second candidate is planned for 2013.
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1006281_13_item7_p20_s3
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1006281_12_item7_p33_s6
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We may need to obtain additional funds for the commercialization of our lead product, taliglucerase alfa, and to further develop the research and clinical development of our other programs.
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We may need to obtain additional funds for the commercialization of taliglucerase alfa and to further develop the research and clinical development of our other programs.
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1006281_13_item7_p45_s0
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1006281_12_item7_p57_s0
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For purposes of determining the fair value of the options to purchase common stock granted to employees and non-employees during the fiscal year ended December 31, 2011, including shares held by non employees that vested during such period, our management used the fair value of our common stock which was the closing sale price of our common stock on the NYSE Amex on the date of calculation.
|
For purposes of determining the fair value of the restricted shares of common stock granted to employees during the fiscal year ended December 31, 2012, our management used the fair value of our common stock which was the closing sale price of our common stock on the NYSE MKT on the date of grant.
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1006281_13_item7_p68_s0
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1006281_12_item7_p79_s0
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As a result of our significant research and development expenditures and the lack of any approved products to generate significant product sales revenue, we have not been profitable and have generated operating losses since our inception.
|
As a result of our significant research and development expenditures and the lack of significant product sales revenue due to the recent launch of taliglucerase alfa in the United States and Israel, we have not been profitable and have generated operating losses since our inception.
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1006281_13_item7_p72_s2
|
1006281_12_item7_p89_s0
|
Net cash used in investing activities for 2011 was $5.9 million and consisted primarily of purchases of property and equipment.
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Net cash used in investing activities for the year ended December 31, 2012 was $2.3 million and consisted primarily of purchases of property and equipment.
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1006281_13_item7_p72_s2
|
1006281_12_item7_p90_s3
|
Net cash used in investing activities for 2010 was $8.0 million and consisted primarily of purchases of property and equipment.
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Net cash used in investing activities for the year ended December 31, 2012 was $2.3 million and consisted primarily of purchases of property and equipment.
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1006281_13_item7_p76_s0
|
1006281_12_item7_p92_s0
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We believe that our existing cash and cash equivalents and the net proceeds from our public underwritten offering of February 2012 will be sufficient to enable us to fund our operating expenses and capital expenditure requirements at least for the next 12 months.
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We believe that our existing cash and cash equivalents will be sufficient to enable us to fund our operating expenses and capital expenditure requirements for at least the next 12 months.
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1006281_13_item7_p77_s0
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1006281_12_item7_p93_s0
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Our future capital requirements will depend on many factors, including the progress and results of our clinical trials, costs of commercialization activities, including product marketing, sales and distribution and whether these efforts will be performed internally or through some form of collaboration with third parties, the duration and cost of discovery and preclinical development, and laboratory testing and clinical trials for our product candidates, the timing and outcome of regulatory review of our product candidates, the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims and other intellectual property rights and the number and development requirements of other product candidates that we pursue.
|
Our future capital requirements will depend on many factors, including the progress of Pfizer's commercialization efforts in the United States, the progress of our commercialization efforts in Israel and, if anticipated marketing approvals of taliglucerase alfa are granted in other jurisdictions, the progress of Pfizer's global commercialization efforts, the progress and results of our clinical trials, the duration and cost of discovery and preclinical development and laboratory testing and clinical trials for our product candidates, the timing and outcome of regulatory review of our product candidates, the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims and other intellectual property rights, the number and development requirements of other product candidates that we pursue and the costs of commercialization activities, including product marketing, sales and distribution.
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1006281_13_item7_p80_s1
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1006281_12_item7_p95_s1
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We do not believe that inflation has had a material effect on our results of operations during the years ended December 31, 2009, 2010 or 2011.
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1006281_13_item7_p79_s1
|
1006281_12_item7_p96_s1
|
We do not believe currency fluctuations have had a material effect on our results of operations during the years ended December 31, 2009, 2010 or 2011.
|
We do not believe that inflation has had a material effect on our results of operations during the years ended December 31, 2010, 2011 or 2012.
| 2 |
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1006281_14_item7_p18_s1
|
1006281_13_item7_p23_s1
|
Most of the Company s revenues are derived in dollars.
|
Most of our revenues are derived in dollars.
| 2 |
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1006281_14_item7_p18_s2
|
1006281_13_item7_p23_s2
|
In addition, most of the Company s expenses and capital expenditures are incurred in dollars, and the major source of the Company s financing has been provided in dollars.
|
In addition, most of our expenses and capital expenditures are incurred in dollars, and the major source of our financing has been provided in dollars.
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1006281_14_item7_p49_s3
|
1006281_13_item7_p54_s2
|
Prior to the FDA's approval of taliglucerase alfa, manufacturing costs related to taliglucerase alfa were not capitalized; rather, such costs were expensed as research and development expenses.
|
Prior to the FDA s approval of taliglucerase alfa, manufacturing costs related to taliglucerase alfa were classified as research and development expenses.
| 2 |
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1006281_14_item7_p67_s2
|
1006281_13_item7_p74_s0
|
Net cash used in investing activities for 2011 was $5.9 million and consisted primarily of purchases of property and equipment.
|
Net cash used in investing activities for the year ended December 31, 2013 was $2.1 million and consisted primarily of purchases of property and equipment.
| 2 |
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1006281_14_item7_p74_s1
|
1006281_13_item7_p79_s1
|
We do not believe that inflation has had a material effect on our results of operations during the years ended December 31, 2010, 2011 or 2012.
|
We do not believe currency fluctuations have had a material effect on our results of operations during the years ended December 31, 2011, 2012 or 2013.
| 2 |
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1006281_14_item7_p73_s1
|
1006281_13_item7_p80_s1
|
We do not believe currency fluctuations have had a material effect on our results of operations during the years ended December 31, 2010, 2011 or 2012.
|
We do not believe that inflation has had a material effect on our results of operations during the years ended December 31, 2011, 2012 or 2013.
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1006281_14_item7_p10_s4
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1006281_13_item7_p8_s4
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The milestones were achieved prior to the end of fiscal year 2012 and have been paid in full.
|
The goals were achieved prior to the end of fiscal year 2012 and the $8.3 million payment has been paid in full.
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1006281_15_item7_p1_s1
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1006281_14_item7_p1_s1
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Using our ProCellEx system, we are developing a pipeline of proprietary, biobetter and biosimilar versions of recombinant therapeutic proteins, based on our plant cell-based expression technology, that primarily target large, established pharmaceutical markets and that rely upon known biological mechanisms of action.
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Using our ProCellEx system, we are developing a pipeline of proprietary, clinically superior versions of recombinant therapeutic proteins that primarily target large, established pharmaceutical markets and that rely upon known biological mechanisms of action.
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1006281_15_item7_p1_s3
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1006281_14_item7_p2_s1
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We believe ProCellEx will enable us to develop proprietary recombinant proteins that are therapeutically equivalent or superior to existing recombinant proteins currently marketed for the same indications.
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1006281_15_item7_p1_s5
|
1006281_14_item7_p2_s3
|
We are now also applying the unique properties of our ProCellEx system for the oral delivery of therapeutic proteins, with the first two product candidates being glucocerebrosidase and antiTNF fusion protein.
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We are now also applying the unique properties of our ProCellEx system for the oral delivery of therapeutic proteins.
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1006281_15_item7_p39_s0
|
1006281_14_item7_p33_s0
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We expect our research and development expenses to continue to be our primary expense in the future as we continue the advancement of our clinical trials and preclinical product development programs for our product candidates other than taliglucerase alfa.
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We expect our research and development expenses to continue to be our primary expense in the future as we continue the advancement of our clinical trials and preclinical product development programs for our product candidates.
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1006281_15_item7_p66_s1
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1006281_14_item7_p50_s1
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The decrease resulted primarily from a decrease of $2.1 million in payroll and related expenses primarily due to a decrease in share-based compensation and a decrease of $1.2 million resulting from the winding down of certain clinical trials for taliglucerase alfa.
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1006281_14_item7_p52_s1
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The decrease resulted primarily from a decrease of $1.5 million in payroll and related expenses primarily due to a decrease in share-based compensation.
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1006281_15_item7_p63_s3
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1006281_14_item7_p57_s2
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Prior to the FDA s approval of taliglucerase alfa, manufacturing costs related to taliglucerase alfa were not capitalized; rather, such costs were expensed as research and development expenses.
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1006281_15_item7_p75_s1
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1006281_14_item7_p69_s3
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We expect to continue to incur significant research and development expenses, including expenses related primarily to the clinical trials of PRX-102 and oral glucocerebrosidase and the advancement of our other product candidates into clinical trials.
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1006281_15_item7_p80_s1
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1006281_14_item7_p73_s1
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We do not believe that inflation has had a material effect on our results of operations during the years ended December 31, 2011, 2012 or 2013.
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1006281_15_item7_p79_s1
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1006281_14_item7_p74_s1
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We do not believe currency fluctuations have had a material effect on our results of operations during the years ended December 31, 2011, 2012 or 2013.
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We do not believe that inflation has had a material effect on our results of operations during the years ended December 31, 2012, 2013 or 2014.
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1006281_16_item7_p7_s0
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1006281_15_item7_p16_s0
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In addition to taliglucerase alfa, we are developing an innovative product pipeline using our ProCellEx protein expression system.
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We are developing an innovative product pipeline using our ProCellEx protein expression system.
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1006281_16_item7_p10_s0
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1006281_15_item7_p18_s0
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(2) PRX-106, our oral antiTNF product candidate which is being developed as an orally-delivered anti inflammatory treatment for various inflammatory diseases using plant cells as a natural capsule for the expressed protein.
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(3) OPRX-106, our oral antiTNF product candidate which is being developed as an orally-delivered anti-inflammatory treatment using plant cells as a natural capsule for the expressed protein.
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1006281_16_item7_p1_s1
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1006281_15_item7_p1_s1
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Using our ProCellEx system, we are developing a pipeline of proprietary, clinically superior versions of recombinant therapeutic proteins that primarily target large, established pharmaceutical markets and that rely upon known biological mechanisms of action.
|
We developed our first commercial drug product, Elelyso TM , using our ProCellEx system and we are focused on utilizing the system to develop a pipeline of proprietary, clinically superior versions of recombinant therapeutic proteins that primarily target large, established pharmaceutical markets and that in most cases rely upon known biological mechanisms of action.
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1006281_16_item7_p1_s2
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1006281_15_item7_p1_s3
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With our experience, and having successfully developed Elelyso, our first drug product, we believe ProCellEx will enable us to develop additional proprietary recombinant proteins that are therapeutically superior to existing recombinant proteins currently marketed for the same indications.
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With our experience to date, we believe ProCellEx will enable us to develop additional proprietary recombinant proteins that are therapeutically superior to existing recombinant proteins currently marketed for the same indications.
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1006281_16_item7_p2_s0
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1006281_15_item7_p2_s0
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On May 1, 2012, the U.S. Food and Drug Administration, or the FDA, approved for sale our first commercial product, taliglucerase alfa for injection, which is being marketed in the United States and Israel under the brand name Elelyso, as an enzyme replacement therapy, or ERT, for the long-term treatment of adult patients with a confirmed diagnosis of type 1 Gaucher disease.
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On May 1, 2012, the FDA approved for sale our first commercial product, taliglucerase alfa for injection, an enzyme replacement therapy, or ERT, for the long-term treatment of adult patients with a confirmed diagnosis of type 1 Gaucher disease.
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1006281_15_item7_p50_s0
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The risk-free interest rate described above has been based on the implied yield of U.S. federal reserve zero coupon government bonds.
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1006281_15_item7_p58_s1
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1006281_16_item7_p66_s0
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1006281_15_item7_p77_s0
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Our future capital requirements will depend on many factors, including the progress of Pfizer s commercialization efforts for taliglucerase alfa in the United States and other countries and, if anticipated marketing approvals of taliglucerase alfa are granted in other jurisdictions, the progress of Pfizer s global commercialization efforts for taliglucerase alfa, the progress and results of our clinical trials, the duration and cost of discovery and preclinical development and laboratory testing and clinical trials for our product candidates, the timing and outcome of regulatory review of our product candidates, the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims and other intellectual property rights, the number and development requirements of other product candidates that we pursue and the costs of commercialization activities, including product marketing, sales and distribution.
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1006281_16_item7_p69_s1
|
1006281_15_item7_p79_s1
|
We do not believe that inflation has had a material effect on our results of operations during the years ended December 31, 2012, 2013 or 2014.
|
We do not believe currency fluctuations have had a material effect on our results of operations during the years ended December 31, 2013, 2014 or 2015.
| 2 |
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1006281_16_item7_p68_s1
|
1006281_15_item7_p80_s1
|
We do not believe currency fluctuations have had a material effect on our results of operations during the years ended December 31, 2012, 2013 or 2014.
|
We do not believe that inflation has had a material effect on our results of operations during the years ended December 31, 2013, 2014 or 2015.
| 2 |
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1006281_17_item7_p30_s0
|
1006281_16_item7_p30_s0
|
The costs and expenses of our projects are partially funded by grants we have received from the OCS.
|
The costs and expenses of our projects are partially funded by grants we have received from NATI.
| 2 |
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1006281_17_item7_p31_s0
|
1006281_16_item7_p31_s0
|
There can be no assurance that we will continue to receive grants from the OCS in amounts sufficient for our operations, if at all.
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There can be no assurance that we will continue to receive grants from NATI in amounts sufficient for our operations, if at all.
| 2 |
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1006281_17_item7_p56_s1
|
1006281_16_item7_p48_s1
|
Cost of revenues consists primarily of products we sold in Brazil for which revenues were recognized during the period and royalties payable to the OCS and to a certain academic institution in connection with such sales.
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1006281_17_item7_p60_s1
|
1006281_16_item7_p52_s1
|
Financial expenses resulted primarily from interest expense of $3.1 million for the notes.
|
Financial expenses resulted primarily from interest expense of $3.1 million for our outstanding 4.5% convertible notes.
| 2 |
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1006281_17_item7_p56_s1
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1006281_16_item7_p54_s1
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Cost of revenues consists primarily of products we sold in Brazil for which revenues were recognized during the period, and royalties payable to the OCS and to a certain academic institution in connection with such sales.
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Cost of revenues consists primarily of products we sold in Brazil for which revenues were recognized during the period and royalties payable to NATI and to a certain academic institution in connection with such sales.
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1006281_16_item7_p68_s1
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We do not believe that inflation has had a material effect on our results of operations during the years ended December 31, 2013, 2014 or 2015.
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We do not believe currency fluctuations have had a material effect on our results of operations during the years ended December 31, 2014, 2015 or 2016.
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1006281_17_item7_p70_s1
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1006281_16_item7_p69_s1
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We do not believe currency fluctuations have had a material effect on our results of operations during the years ended December 31, 2013, 2014 or 2015.
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We do not believe that inflation has had a material effect on our results of operations during the years ended December 31, 2014, 2015 or 2016.
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1006281_17_item7_p11_s0
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1006281_16_item7_p9_s0
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(2) PRX-110, a proprietary plant cell recombinant human Deoxyribonuclease 1, or AIR DNase TM , under development for the treatment of cystic fibrosis, to be administered by inhalation.
|
(2) PRX-110, a proprietary plant cell recombinant human Deoxyribonuclease 1, or alidornase alfa, under development for the treatment of cystic fibrosis, to be administered by inhalation.
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1006281_18_item7_p15_s0
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1006281_17_item7_p10_s0
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(1) PRX-102, or alpha-GAL-A , a therapeutic protein candidate for the treatment of Fabry disease, a rare, genetic lysosomal disorder in humans, currently in an ongoing phase III clinical trial.
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(1) pegunigalsidase alfa, or PRX-102, a therapeutic protein candidate for the treatment of Fabry disease, a rare, genetic lysosomal disorder in humans, currently in an ongoing phase III clinical trial.
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1006281_18_item7_p35_s1
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1006281_17_item7_p33_s1
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While we are currently focused on advancing each of our product development programs, our future research and development expenses will depend on the clinical success of each product candidate, as well as ongoing assessments of each product candidate s commercial potential.
|
Our future research and development expenses for pegunigalsidase alfa and the other product candidates will depend on the clinical success of each product candidate, as well as ongoing assessments of each product candidate s commercial potential.
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1006281_18_item7_p36_s0
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1006281_17_item7_p34_s0
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We expect our research and development expenses to continue to be our primary expense in the future as we continue the advancement of our clinical trials and preclinical product development programs for our product candidates.
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We expect our research and development expenses to continue to be our primary expense in the future as we continue the advancement of our clinical trials and preclinical product development programs for our product candidates, particularly with respect to the development of pegunigalsidase alfa.
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1006281_18_item7_p54_s0
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1006281_17_item7_p52_s0
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We expect research and development expenses to continue to be our primary expense as we enter into a more advanced stage of preclinical and clinical trials for certain of our product candidates .
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We expect research and development expenses to continue to be our primary expense as we enter into a more advanced stage of preclinical and clinical trials for certain of our product candidates, primarily with respect to pegunigalsidase alfa .
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1006281_17_item7_p58_s0
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1006281_17_item7_p65_s0
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Net cash used in operations was $32.1 million for the year ended December 31, 2016.
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Net cash used in operations was $10.0 million for the year ended December 31, 2017.
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1006281_18_item7_p68_s0
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1006281_17_item7_p66_s0
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Net cash used in operations was $24.2 million for the year ended December 31, 2015.
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Net cash used in operations was $10.0 million for the year ended December 31, 2017.
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1006281_17_item7_p68_s0
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Our future capital requirements will depend on many other factors, including our progress in commercializing Uplyso in Brazil, the progress and results of our clinical trials, the duration and cost of discovery and preclinical development and laboratory testing and clinical trials for our product candidates, conversions of our convertible notes from time to time, the timing and outcome of regulatory review of our product candidates, the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims and other intellectual property rights, the number and development requirements of other product candidates that we pursue and the costs of commercialization activities, including product marketing, sales and distribution.
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1006281_18_item7_p74_s1
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1006281_17_item7_p70_s1
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We do not believe that inflation has had a material effect on our results of operations during the years ended December 31, 2014, 2015 or 2016.
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We do not believe currency fluctuations have had a material effect on our results of operations during the years ended December 31, 2015, 2016 or 2017.
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1006281_18_item7_p73_s1
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1006281_17_item7_p71_s1
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We do not believe currency fluctuations have had a material effect on our results of operations during the years ended December 31, 2014, 2015 or 2016.
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We do not believe that inflation has had a material effect on our results of operations during the years ended December 31, 2015, 2016 or 2017.
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1006281_18_item7_p13_s2
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1006281_17_item7_p8_s3
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Fiocruz s purchases of Uplyso to date have been significantly below certain agreed upon purchase milestones and, accordingly, we have the right to terminate the Brazil Agreement.
|
Fiocruz s purchases of alfataliglicerase to date have been significantly below certain agreed upon purchase milestones and, accordingly, we have the right to terminate the Brazil Agreement.
| 2 |
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1006281_18_item7_p13_s3
|
1006281_17_item7_p8_s4
|
Notwithstanding the low purchase amounts, we are, at this time, continuing to supply Uplyso to Fiocruz under the Brazil Agreement, and patients continue to be treated with Uplyso in Brazil.
|
Notwithstanding, we are, at this time, continuing to supply alfataliglicerase to Fiocruz under the Brazil Agreement, and patients continue to be treated with alfataliglicerase in Brazil.
| 2 |
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1009759_12_item7_p127_s3
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1009759_11_item7_p113_s3
|
We could seek to raise such funds by selling additional securities to the public or to selected investors, or by obtaining additional debt financing.
|
The Company could seek to raise such funds by exercising the Put Option, by selling additional securities to the public or to selected investors, or by obtaining additional debt financing.
| 2 |
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1009759_12_item7_p127_s4
|
1009759_11_item7_p113_s4
|
We cannot be assured that we will be able to obtain additional funds on commercially favorable terms, or at all.
|
There is no assurance that the Company will be able to obtain additional funds on commercially favorable terms, or at all.
| 2 |
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1009759_12_item7_p129_s0
|
1009759_11_item7_p114_s0
|
Depending on the timing and product mix of our future sales and collection of related receivables, our management of inventory costs and the timing of inventory purchases and deliveries required to fulfill the current backlog, our future capital requirements may vary materially from those now planned.
|
Although we believe we have sufficient capital to fund our working capital and capital expenditures for at least the next twelve months, depending on the timing of our future sales and collection of related receivables, managing inventory costs and the timing of inventory purchases and deliveries required to fulfill the current backlog, our future capital requirements may vary materially from those now planned.
| 2 |
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1009759_12_item7_p132_s4
|
1009759_11_item7_p117_s4
|
Certain industries in which our customers do business and certain geographic areas may have been and could continue to be adversely affected by the recession in economic activity.
|
Certain industries in which our customers do business and certain geographic areas may have been and could continue to be adversely affected by the current economic environment.
| 2 |
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1009759_12_item7_p19_s0
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1009759_11_item7_p15_s1
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The second phase of the program is expected to incorporate further engine efficiency improvements, resulting in a product with a projected electrical efficiency of 42% and targeted power output of 370 kW. The DOE awarded us a grant of $5.0 million in support of this development program.
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electrical efficiency of 42% and targeted power output of 370 kW. The DOE awarded us a grant of $5.0 million in support of this development program.
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1009759_12_item7_p26_s2
|
1009759_11_item7_p23_s0
|
include a significant change in the manner of the use of the asset or a significant negative industry or economic trend.
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1009759_12_item7_p37_s0
|
1009759_11_item7_p33_s0
|
Our revenue consists of sales of products, parts, accessories and service, net of discounts.
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Our revenue consists of sales of products, parts, accessories and service, which includes FPPs, net of discounts.
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1009759_12_item7_p50_s1
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1009759_11_item7_p40_s1
|
Determining the amount of stock-based compensation to be recorded requires us to develop estimates to be used in calculating the grant-date fair value of stock options.
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Determining the warrant liability to be recorded requires us to develop estimates to be used in calculating the fair value of the warrants.
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1009759_12_item7_p51_s0
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1009759_11_item7_p41_s0
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The use of Black Scholes model requires us to make estimates of the following assumptions:
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The use of the Monte Carlo simulation model requires us to make estimates of the following assumptions:
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1009759_12_item7_p45_s1
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1009759_11_item7_p46_s1
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Determining the warrant liability to be recorded requires us to develop estimates to be used in calculating the fair value of the warrants.
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Determining the amount of stock-based compensation to be recorded requires us to develop estimates to be used in calculating the grant-date fair value of stock options.
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1009759_12_item7_p46_s0
|
1009759_11_item7_p47_s0
|
The use of the Monte Carlo simulation model requires us to make estimates of the following assumptions:
|
The use of Black-Scholes model requires us to make estimates of the following assumptions:
| 2 |
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1009759_12_item7_p82_s2
|
1009759_11_item7_p54_s0
|
Sales to BPC accounted for 23% and 14% of our revenue for the years ended March 31, 2011 and 2010, respectively.
|
Sales to Aquatec accounted for 4% and 14% of our revenue for the years ended March 31, 2011 and 2010, respectively.
| 2 |
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1009759_12_item7_p82_s2
|
1009759_11_item7_p54_s1
|
Sales to Pumps and Service accounted for 18% and 4% our revenue for the years ended March 31, 2011 and 2010, respectively.
|
Sales to Aquatec accounted for 4% and 14% of our revenue for the years ended March 31, 2011 and 2010, respectively.
| 2 |
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1009759_12_item7_p60_s0
|
1009759_11_item7_p55_s0
|
Cost of goods sold includes direct material costs, production and service center labor and overhead, inventory charges and provision for estimated product warranty expenses.
|
Gross Margin (Loss) Cost of goods sold includes direct material costs, production and service center labor and overhead, inventory charges and provision for estimated product warranty expenses.
| 2 |
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1009759_12_item7_p6_s0
|
1009759_11_item7_p5_s2
|
In exchange for certain minimum purchase requirements during a three-year period, we have exclusive rights to sell the zero-emission waste heat recovery generator for all microturbine applications and for applications 500 kW or lower where the source of heat is the exhaust of a reciprocating engine used in a landfill application.
|
to sell the zero-emission waste heat recovery generator for all microturbine applications and for applications 500 kW or lower where the source of heat is the exhaust of a reciprocating engine used in a landfill application.
| 2 |
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1009759_12_item7_p73_s2
|
1009759_11_item7_p66_s2
|
As of March 31, 2011, we had total debt of $7.1 million outstanding under the revolving Credit Facility.
|
As of March 31, 2012, we had total debt of $10.4 million outstanding under the Credit Facility.
| 2 |
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1009759_12_item7_p76_s4
|
1009759_11_item7_p70_s0
|
net deferred tax asset of $231.0 million at March 31, 2011 because the realization of the benefits of these favorable tax attributes in future income tax returns is not deemed more likely than not.
|
We provided a valuation allowance for 100% of our net deferred tax asset of $234.4 million at March 31, 2012 because the realization of the benefits of these favorable tax attributes in future income tax returns is not deemed more likely than not.
| 2 |
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1009759_12_item7_p75_s1
|
1009759_11_item7_p85_s4
|
This change in fair value of warrant liability was a result of revaluing the warrant liability, impacted primarily by the quoted price of the Company's common stock in an active market.
|
This change in fair value of warrant liability was a result of warrant exercises and revaluing the warrant liability based on the Monte Carlo simulation valuation model which is impacted primarily by the quoted price of the Company's common stock in an active market.
| 2 |
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