5175000 5.25 91923406 1500000 8580000 -8703000 150000000 44054000 0.001 86000 85581744 -154189000 145400000 89000 7863000 55109000 731000 150000000 1072000 4045000 76441000 4858000 84304000 11962000 1536000 1029000 84304000 59280000 21332000 209000 0.001 48640000 65890000 1789000 4512000 17342000 4680000 92000 91922406 -168239000 176010000 0.60 0.40 -11323000 35900000 81000 81248472 -135448000 124044000 -26077000 59189000 279000 1043000 3837000 77882000 6121000 51805000 7540000 1374000 279000 51805000 27001000 18693000 50923000 32491000 1700000 5032000 18271000 6566000 86000 85630157 -171977000 145814000 -18906000 521000 521000 -0.22 4770000 259000 -8811000 -4093000 149000 20590000 4016000 8154000 3788000 77000 83686094 250000 -2049000 16000 -0.22 19331000 20909000 910000 73000 83686094 -652000 4892000 77000 472000 1410000 -18741000 165000 149000 1801000 60000 1995000 15590000 -3510000 20650000 3741000 256000 265000 333272 4000 1000 4000000 -18741000 521000 20586000 249000 7537094 PLX PROTALIX BIOTHERAPEUTICS, INC. false Accelerated Filer Q2 2012 10-Q 2012-06-30 0001006281 --12-31 <div style="FONT: 10pt Times New Roman, Times, Serif"> <table style="MARGIN-TOP: 0pt; FONT: 10pt Times New Roman, Times, Serif; MARGIN-BOTTOM: 0pt" cellspacing="0" cellpadding="0" width="100%"> <tr style="VERTICAL-ALIGN: top"> <td style="WIDTH: 0.5in"></td> <td style="WIDTH: 0.25in"><b>b.</b></td> <td style="PADDING-RIGHT: 81.35pt"><b>Basis of Presentation</b></td> </tr> </table> <p style="MARGIN-TOP: 0pt; FONT: 10pt Times New Roman, Times, Serif; MARGIN-BOTTOM: 0pt"> &#xA0;</p> <p style="MARGIN: 0pt 0px 0pt 56.7pt; FONT: 10pt Times New Roman, Times, Serif"> The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States (<font style="TEXT-TRANSFORM: uppercase">"</font>GAAP<font style="TEXT-TRANSFORM: uppercase">"</font>) for interim financial information. Accordingly, they do not include all of the information and notes required by GAAP for annual financial statements. In the opinion of management, all adjustments (of a normal recurring nature) considered necessary for a fair statement of the results for the interim periods presented have been included. Operating results for the interim period are not necessarily indicative of the results that may be expected for the full year.</p> <p style="MARGIN: 0pt 0px 0pt 56.7pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="MARGIN: 0pt 0px 0pt 56.7pt; FONT: 10pt Times New Roman, Times, Serif"> These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements in the Annual Report on Form 10-K for the year ended December 31, 2011, filed by the Company with the Securities and Exchange Commission. The comparative balance sheet at December 31, 2011 has been derived from the audited financial statements at that date.</p> </div> <div style="FONT: 10pt Times New Roman, Times, Serif"> <p style="MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"><b>NOTE 3 - STOCK TRANSACTIONS</b></p> <p style="MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <table style="MARGIN-TOP: 0pt; FONT: 10pt Times New Roman, Times, Serif; MARGIN-BOTTOM: 0pt" cellspacing="0" cellpadding="0" width="100%"> <tr style="VERTICAL-ALIGN: top"> <td style="WIDTH: 49.65pt"></td> <td style="WIDTH: 21.25pt"><b>a.</b></td> <td><font style="COLOR: black">On February 22,&#xA0;2012, the Company issued and sold 5,175,000 shares of Common Stock in an underwritten public offering at a price to the public of $5.25 per share. The net proceeds to the Company were approximately $25,388,000&#xA0;(net of underwriting commissions and issuance costs of approximately $1,780,000).</font></td> </tr> </table> <p style="MARGIN-TOP: 0pt; FONT: 10pt Times New Roman, Times, Serif; MARGIN-BOTTOM: 0pt"> &#xA0;</p> <table style="MARGIN-TOP: 0pt; FONT: 10pt Times New Roman, Times, Serif; MARGIN-BOTTOM: 0pt" cellspacing="0" cellpadding="0" width="100%"> <tr style="VERTICAL-ALIGN: top"> <td style="WIDTH: 49.65pt"></td> <td style="WIDTH: 21.25pt"><b>b.</b></td> <td>During the six months ended June 30, 2012, the Company issued a total of 1,117,249 shares of Common Stock in connection with the exercise of a total of 1,117,249 options by certain officers and employees of the Company. The Company received aggregate cash proceeds equal to approximately $1,055,000 in connection with such exercises.</td> </tr> </table> <p style="MARGIN-TOP: 0pt; FONT: 10pt Times New Roman, Times, Serif; MARGIN-BOTTOM: 0pt"> &#xA0;</p> <table style="MARGIN-TOP: 0px; FONT: 10pt Times New Roman, Times, Serif; MARGIN-BOTTOM: 0pt" cellspacing="0" cellpadding="0"> <tr style="TEXT-ALIGN: justify; VERTICAL-ALIGN: top"> <td style="WIDTH: 49.65pt"></td> <td style="TEXT-ALIGN: left; WIDTH: 21.25pt"><b>c.</b></td> <td style="TEXT-ALIGN: justify">Following FDA <font style="FONT: 10pt Times New Roman, Times, Serif">approval of taliglucerase alfa on May 1, 2012<font style="COLOR: black">, the Company started recognizing compensation costs in relation to performance-based awards that were granted in February 2010 to certain officers and employees of the Company which vest over a three-year period commencing upon the FDA's approval of</font> taliglucerase alfa<font style="COLOR: black">. During the second quarter of 2012, the Company recorded an expense in the amount of approximately $3.5 million for the cumulative period from the date of grant.</font></font></td> </tr> </table> </div> 3555000 3759000 3759000 0.04 2128000 <div style="FONT: 10pt Times New Roman, Times, Serif"> <p style="MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"><b>NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES</b></p> <p style="MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <table style="MARGIN-TOP: 0pt; FONT: 10pt Times New Roman, Times, Serif; MARGIN-BOTTOM: 0pt" cellspacing="0" cellpadding="0" width="100%"> <tr style="VERTICAL-ALIGN: top"> <td style="WIDTH: 0.5in"></td> <td style="WIDTH: 0.5in"><b>a.</b></td> <td><b>General</b></td> </tr> </table> <p style="MARGIN-TOP: 0pt; FONT: 10pt Times New Roman, Times, Serif; MARGIN-BOTTOM: 0pt"> &#xA0;</p> <table style="MARGIN-TOP: 0pt; FONT: 10pt Times New Roman, Times, Serif; MARGIN-BOTTOM: 0pt" cellspacing="0" cellpadding="0" width="100%"> <tr style="VERTICAL-ALIGN: top"> <td style="WIDTH: 0.75in"></td> <td style="WIDTH: 0.25in"><b>1.</b></td> <td>Operation</td> </tr> </table> <p style="MARGIN-TOP: 0pt; FONT: 10pt Times New Roman, Times, Serif; MARGIN-BOTTOM: 0pt"> &#xA0;</p> <p style="TEXT-INDENT: 0in; MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> Protalix BioTherapeutics, Inc. (collectively with its subsidiaries, the "Company"), and its wholly-owned subsidiary, Protalix Ltd., are biopharmaceutical companies focused on the development and commercialization of recombinant therapeutic proteins based on the Company&#x2019;s proprietary ProCellEx<sup>&#xAE;</sup> protein expression system ("ProCellEx"). In September 2009, Protalix Ltd. formed another wholly-owned subsidiary under the laws of the Netherlands, Protalix B.V., in connection with the European Medicines Agency ("EMA") application process in the European Union. The Company&#x2019;s two subsidiaries are referred to collectively herein as the "Subsidiaries."</p> <p style="TEXT-INDENT: 0in; MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="TEXT-INDENT: 0in; MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> On May 1, 2012, the U.S. Food and Drug Administration (<font style="TEXT-TRANSFORM: uppercase">"</font>FDA<font style="TEXT-TRANSFORM: uppercase">"</font>) approved taliglucerase alfa for injection, the Company&#x2019;s first approved drug product, as an enzyme replacement therapy (ERT) for the long-term treatment of adult patients with a confirmed diagnosis of type 1 Gaucher disease. Taliglucerase alfa is a proprietary, recombinant form of glucocerebrosidase (GCD) that the Company developed using ProCellEx. Taliglucerase alfa is the first FDA-approved plant cell-based recombinant therapeutic protein.</p> <p style="TEXT-INDENT: 0in; MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> Taliglucerase alfa is being marketed in the United States under the brand name ELELYSO&#x2122; by Pfizer Inc. (<font style="TEXT-TRANSFORM: uppercase">"</font>Pfizer<font style="TEXT-TRANSFORM: uppercase">"</font>), the Company's commercialization partner, as provided in the exclusive license and supply agreement by and between Protalix Ltd. and Pfizer (the <font style="TEXT-TRANSFORM: uppercase">"</font>Pfizer Agreement<font style="TEXT-TRANSFORM: uppercase">"</font>). Protalix Ltd. granted Pfizer an exclusive, worldwide license to develop and commercialize taliglucerase alfa under the Pfizer Agreement, but retained those rights in Israel. The Company has agreed to a specific allocation between Protalix Ltd. and Pfizer regarding the responsibilities for the continued development efforts for taliglucerase alfa. To date, the Company has received an upfront payment of $60.0 million in connection with the execution of the Pfizer Agreement and shortly thereafter an additional $5.0 million clinical development-related milestone payment. The Company received an additional $25.0 million milestone payment in connection with the FDA's approval of taliglucerase alfa in the United States, which are recorded as revenues during the current period. The agreement provides that the Company share with Pfizer the net profits or loss related to the development and commercialization of taliglucerase alfa on a 40% and 60% basis, respectively, except with respect to the profits and losses related to commercialization efforts in Israel. <font style="COLOR: black">In calculating the net profits under the agreement, there are certain agreed upon limits on the amounts that may be deducted from gross sales for certain expenses and costs of goods sold</font>.</p> <p style="MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> The Company is cooperating with Pfizer to obtain marketing approval for taligulcerase alfa in additional countries and jurisdictions. Currently, marketing authorization applications have been filed for the European Union, Israel, Brazil and Australia. In June 2012, the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted an opinion recommending against the marketing authorization of taliglucerase alfa in the European Union. While the CHMP gave a positive risk-benefit assessment for taliglucerase alfa, its recommendation was based solely on the orphan market exclusivity granted to VPRIV<sup>&#xAE;</sup>, Shire plc's Gaucher disease treatment. It was not based on the safety and efficacy profile of taliglucerase alfa. The Company and Pfizer are currently working together, along with other interested parties, to determine the next steps regarding the CHMP opinion.</p> <p style="MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> In addition to taliglucerase alfa, the Company is developing certain other products using ProCellEx.</p> <p style="MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"></p> <p style="MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"></p> <p style="TEXT-ALIGN: center; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> </p> <p style="MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> Currently, patients are being treated with taliglucerase alfa on a commercial basis in the United States, and, both within and outside of the United States, through the Company's clinical 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. In July 2009, following a request by the FDA, the Company submitted a treatment protocol to the FDA in order to address an expected shortage of the current enzyme replacement therapy approved for Gaucher disease. The treatment protocol was approved by the FDA in August 2009, and the Company is continuing to treat patients in the United States under this protocol as it winds down with patients being moved to commercial treatment with Elelyso. On July 13, 2010, the Company announced that the French regulatory authority had granted an Autorisation Temporaire d'Utilisation (ATU), or Temporary Authorization for Use, for taliglucerase alfa for the treatment of Gaucher disease. An ATU is the regulatory mechanism used by the French Health Products and Safety Agency to make non-approved drugs available to patients in France when a genuine public health need exists. This ATU allows Gaucher patients in France to receive treatment with taliglucerase alfa before marketing authorization for the product is granted in the European Union. Payment for taliglucerase alfa has been secured through government allocations to hospitals. In addition to the United States and France, taliglucerase alfa is currently being provided to Gaucher patients under special access agreements or named patient provisions in Brazil and in other countries.</p> <p style="MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> On August 10, 2010, Pfizer entered into a short-term supply agreement with the Ministry of Health of Brazil pursuant to which the Company and Pfizer have provided taliglucerase alfa to the Brazilian Ministry of Health for the treatment of Gaucher patients. During the remainder of 2010 and the first quarter of 2011, the Company and Pfizer completed the supply of products deliverable under the short-term supply agreement. During 2011, Pfizer recorded an allowance for sales returns in connection with the supply agreement because the Brazilian Ministry of Health requested that Pfizer consider the replacement of certain vials that might expire during 2012. Revenue, net of allowance for sales returns, generated from the Brazilian Ministry of Health was recorded by Pfizer, and the Company recorded its share of such revenues in accordance with the terms and conditions of the Pfizer Agreement.</p> <p style="MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <table style="MARGIN-TOP: 0pt; FONT: 10pt Times New Roman, Times, Serif; MARGIN-BOTTOM: 0pt" cellspacing="0" cellpadding="0" width="100%"> <tr style="VERTICAL-ALIGN: top"> <td style="WIDTH: 0.75in"></td> <td style="WIDTH: 0.25in"><b>2.</b></td> <td>Liquidity and Financial Resources</td> </tr> </table> <p style="MARGIN-TOP: 0pt; FONT: 10pt Times New Roman, Times, Serif; MARGIN-BOTTOM: 0pt"> &#xA0;</p> <p style="MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> In addition to the FDA approval, successful completion of the Company&#x2019;s development programs and its transition to normal operations is dependent upon obtaining the foreign regulatory approvals required to sell its products internationally. In accordance with the terms and conditions of the Pfizer Agreement, the Company received a $25.0 million milestone payment in connection with the FDA's approval of taliglucerase alfa in the United States. In addition, the Company is eligible to receive potential milestone payments equal to $25.0 million, in the aggregate, for matters relating to the successful achievement of regulatory approval of taliglucerase alfa in the European Union. Notwithstanding the FDA's approval of taliglucerase alfa, there can be no assurance that the Company will receive regulatory approval of taliglucerase alfa in the European Union or any other jurisdiction, nor is there any assurance that the Company will receive regulatory approval of any of its other product candidates, and a substantial amount of time may pass before the Company achieves a level of revenues adequate to support its operations, if at all. The Company also expects to incur substantial expenditures in connection with the regulatory approval process for each of its product candidates during their respective developmental periods. Obtaining marketing approval with respect to any product candidate is directly dependent on the Company&#x2019;s ability to implement the necessary regulatory steps required to obtain such approval in the United States and in other countries. The Company cannot reasonably predict the outcome of these activities.</p> <p style="MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> </p> <p style="MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> </p> <p style="MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"></p> <p style="TEXT-ALIGN: center; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> </p> <p style="TEXT-ALIGN: left; MARGIN-TOP: 0px; TEXT-INDENT: 0in; FONT: 10pt Times New Roman, Times, Serif; MARGIN-BOTTOM: 0px; MARGIN-LEFT: 0.75in"> Based on its current cash resources and commitments, the Company believes it will be able to maintain its current planned development activities and the corresponding level of expenditures for at least the next 12 months, although no assurance can be given that it will not need additional funds prior to such time. If there are unexpected increases in general and administrative expenses or research and development expenses, the Company may need to seek additional financing during the next 12 months.</p> <p style="TEXT-INDENT: 0in; MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <table style="MARGIN-TOP: 0pt; FONT: 10pt Times New Roman, Times, Serif; MARGIN-BOTTOM: 0pt" cellspacing="0" cellpadding="0" width="100%"> <tr style="VERTICAL-ALIGN: top"> <td style="WIDTH: 0.5in"></td> <td style="WIDTH: 0.25in"><b>b.</b></td> <td style="PADDING-RIGHT: 81.35pt"><b>Basis of Presentation</b></td> </tr> </table> <p style="MARGIN-TOP: 0pt; FONT: 10pt Times New Roman, Times, Serif; MARGIN-BOTTOM: 0pt"> &#xA0;</p> <p style="MARGIN: 0pt 0px 0pt 56.7pt; FONT: 10pt Times New Roman, Times, Serif"> The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States (<font style="TEXT-TRANSFORM: uppercase">"</font>GAAP<font style="TEXT-TRANSFORM: uppercase">"</font>) for interim financial information. Accordingly, they do not include all of the information and notes required by GAAP for annual financial statements. In the opinion of management, all adjustments (of a normal recurring nature) considered necessary for a fair statement of the results for the interim periods presented have been included. Operating results for the interim period are not necessarily indicative of the results that may be expected for the full year.</p> <p style="MARGIN: 0pt 0px 0pt 56.7pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="MARGIN: 0pt 0px 0pt 56.7pt; FONT: 10pt Times New Roman, Times, Serif"> These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements in the Annual Report on Form 10-K for the year ended December 31, 2011, filed by the Company with the Securities and Exchange Commission. The comparative balance sheet at December 31, 2011 has been derived from the audited financial statements at that date.</p> <p style="MARGIN: 0pt 0px 0pt 56.7pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <table style="MARGIN-TOP: 0pt; FONT: 10pt Times New Roman, Times, Serif; MARGIN-BOTTOM: 0pt" cellspacing="0" cellpadding="0" width="100%"> <tr style="VERTICAL-ALIGN: top"> <td style="WIDTH: 36pt"></td> <td style="WIDTH: 17.85pt"><b>c.</b></td> <td style="PADDING-RIGHT: 81.35pt"><b>Earnings (loss) per share</b></td> </tr> </table> <p style="MARGIN-TOP: 0pt; FONT: 10pt Times New Roman, Times, Serif; MARGIN-BOTTOM: 0pt"> &#xA0;</p> <p style="MARGIN: 0pt 0px 0pt 0.75in; FONT: 10pt Times New Roman, Times, Serif"> Basic earnings (loss) per share are calculated by dividing the net profit (loss) by the weighted average number of shares of the Company's common stock, par value $0.001 (the "Common Stock"), outstanding during each period.</p> <p style="MARGIN: 0pt 0px 0pt 0.75in; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="MARGIN: 0pt 0px 0pt 0.75in; FONT: 10pt Times New Roman, Times, Serif"> Diluted earnings per share are calculated by dividing the net profit by the weighted-average number of shares of common stock outstanding during each period increased to include the number of additional shares of common stock that would have been outstanding if the potentially dilutive shares had been issued. Potentially dilutive shares include outstanding stock options granted to employees and non-employees.</p> <p style="MARGIN: 0pt 0px 0pt 0.75in; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="MARGIN: 0pt 0px 0pt 0.75in; FONT: 10pt Times New Roman, Times, Serif"> </p> <p style="TEXT-ALIGN: left; MARGIN: 0pt 0px 0pt 0.75in; FONT: 10pt Times New Roman, Times, Serif"> The weighted average number of shares outstanding used to calculate earnings (loss) per share were as follows:</p> <p style="TEXT-ALIGN: left; MARGIN: 0pt 0px 0pt 0.75in; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <table style="WIDTH: 90%; BORDER-COLLAPSE: collapse; FONT: 10pt Times New Roman, Times, Serif" cellspacing="0" cellpadding="0" align="right"> <tr style="VERTICAL-ALIGN: bottom"> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt; FONT-WEIGHT: bold"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: center; FONT: bold 10pt Times New Roman, Times, Serif" colspan="6">Six Months Ended</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: center; FONT: bold 10pt Times New Roman, Times, Serif" colspan="6">Three Months Ended</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> </tr> <tr style="VERTICAL-ALIGN: bottom"> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt; FONT-WEIGHT: bold"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: center; FONT: bold 10pt Times New Roman, Times, Serif" colspan="2">June 30, 2012</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: center; FONT: bold 10pt Times New Roman, Times, Serif" colspan="2">June 30, 2011</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: center; FONT: bold 10pt Times New Roman, Times, Serif" colspan="2">June 30, 2012</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: center; FONT: bold 10pt Times New Roman, Times, Serif" colspan="2">June 30, 2011</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> </tr> <tr style="BACKGROUND-COLOR: rgb(204,255,204); VERTICAL-ALIGN: bottom"> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; TEXT-INDENT: -17.45pt; PADDING-LEFT: 18.05pt; WIDTH: 34%; FONT-SIZE: 10pt"> Weighted average common shares outstanding for basic calculation</td> <td style="PADDING-BOTTOM: 1pt; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; WIDTH: 11%; FONT: 10pt Times New Roman, Times, Serif"> 89,702,496</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; WIDTH: 11%; FONT: 10pt Times New Roman, Times, Serif"> 83,686,094</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; WIDTH: 11%; FONT: 10pt Times New Roman, Times, Serif"> 91,526,224</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; WIDTH: 11%; FONT: 10pt Times New Roman, Times, Serif"> 85,579,534</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> </tr> <tr style="BACKGROUND-COLOR: white; VERTICAL-ALIGN: bottom"> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; TEXT-INDENT: -17.3pt; PADDING-LEFT: 0.25in; FONT-SIZE: 10pt"> Weighted average dilutive effect of stock options</td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; FONT: 10pt Times New Roman, Times, Serif"> 2,967,537</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; FONT: 10pt Times New Roman, Times, Serif"> -</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; FONT: 10pt Times New Roman, Times, Serif"> 3,354,943</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; FONT: 10pt Times New Roman, Times, Serif"> -</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> </tr> <tr style="BACKGROUND-COLOR: rgb(204,255,204); VERTICAL-ALIGN: bottom"> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; TEXT-INDENT: -17.45pt; PADDING-LEFT: 18.05pt; FONT-SIZE: 10pt"> Weighted average common shares outstanding for diluted calculation</td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; FONT: 10pt Times New Roman, Times, Serif"> 92,670,033</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; FONT: 10pt Times New Roman, Times, Serif"> 83,686,094</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; FONT: 10pt Times New Roman, Times, Serif"> 94,881,167</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; FONT: 10pt Times New Roman, Times, Serif"> 85,579,534</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> </tr> <tr style="BACKGROUND-COLOR: white; VERTICAL-ALIGN: bottom"> <td style="TEXT-ALIGN: left; TEXT-INDENT: -17.3pt; PADDING-LEFT: 0.25in; FONT-SIZE: 10pt"> &#xA0;</td> <td style="FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: right; FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt">&#xA0;</td> <td style="FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: right; FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt">&#xA0;</td> <td style="FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: right; FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt">&#xA0;</td> <td style="FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: right; FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt">&#xA0;</td> </tr> </table> <br style="CLEAR: both" /> <p style="TEXT-ALIGN: left; MARGIN: 0pt 0px 0pt 0.75in; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="TEXT-ALIGN: left; MARGIN: 0pt 0px 0pt 0.75in; FONT: 10pt Times New Roman, Times, Serif"> Diluted earnings (loss) per share do not include options of the Company in the amount of 7,537,094 and 1,785,542 shares of Common Stock for the six months ended June 30, 2011 and 2012, respectively, and 7,435,271 and 1,785,542 shares of Common Stock for the three months ended June 30, 2011 and 2012, respectively, because the effect would be anti-dilutive.</p> </div> 1086000 6843000 -1091000 -3546000 25388000 1047000 <div style="FONT: 10pt Times New Roman, Times, Serif"> <p style="MARGIN: 0pt 0px 0pt 0.75in; FONT: 10pt Times New Roman, Times, Serif"> Inventory at June 30, 2012 and December&#xA0;31, 2011 consisted of the following:</p> <p style="MARGIN: 0pt 0px 0pt 0.75in; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="MARGIN: 0pt 0px 0pt 0.75in; FONT: 10pt Times New Roman, Times, Serif"> </p> <table style="WIDTH: 85%; BORDER-COLLAPSE: collapse; FONT: 10pt Times New Roman, Times, Serif" cellspacing="0" cellpadding="0" align="center"> <tr style="VERTICAL-ALIGN: bottom"> <td style="TEXT-ALIGN: center; FONT-SIZE: 10pt; FONT-WEIGHT: bold"> &#xA0;</td> <td style="FONT-SIZE: 10pt; FONT-WEIGHT: bold">&#xA0;</td> <td style="TEXT-ALIGN: center; FONT-SIZE: 10pt; FONT-WEIGHT: bold" colspan="2">June 30,</td> <td style="FONT-SIZE: 10pt; FONT-WEIGHT: bold">&#xA0;</td> <td style="FONT-SIZE: 10pt; FONT-WEIGHT: bold">&#xA0;</td> <td style="TEXT-ALIGN: center; FONT-SIZE: 10pt; FONT-WEIGHT: bold" colspan="2">December 31,</td> <td style="FONT-SIZE: 10pt; FONT-WEIGHT: bold">&#xA0;</td> </tr> <tr style="VERTICAL-ALIGN: bottom"> <td style="TEXT-ALIGN: center; FONT-SIZE: 10pt; FONT-WEIGHT: bold"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: center; FONT: 10pt Times New Roman, Times, Serif" colspan="2"> <p style="TEXT-ALIGN: center; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> <b>2012</b></p> </td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: center; FONT: 10pt Times New Roman, Times, Serif" colspan="2"> <p style="TEXT-ALIGN: center; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> <b>2011</b></p> </td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> </tr> <tr style="VERTICAL-ALIGN: bottom"> <td style="FONT-SIZE: 10pt">&#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: center; FONT: 10pt Times New Roman, Times, Serif" colspan="6">(U.S. dollars in thousands)</td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> </tr> <tr style="BACKGROUND-COLOR: rgb(204,255,204); VERTICAL-ALIGN: bottom"> <td style="TEXT-ALIGN: left; WIDTH: 64%; FONT-SIZE: 10pt">Raw materials</td> <td style="WIDTH: 1%; FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: left; WIDTH: 1%; FONT-SIZE: 10pt">$</td> <td style="TEXT-ALIGN: right; WIDTH: 15%; FONT-SIZE: 10pt">731</td> <td style="TEXT-ALIGN: left; WIDTH: 1%; FONT-SIZE: 10pt"> &#xA0;</td> <td style="WIDTH: 1%; FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: left; WIDTH: 1%; FONT-SIZE: 10pt">$</td> <td style="TEXT-ALIGN: right; WIDTH: 15%; FONT-SIZE: 10pt">279</td> <td style="TEXT-ALIGN: left; WIDTH: 1%; FONT-SIZE: 10pt"> &#xA0;</td> </tr> <tr style="BACKGROUND-COLOR: white; VERTICAL-ALIGN: bottom"> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt">Work in progress</td> <td style="FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: right; FONT-SIZE: 10pt">89</td> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt">&#xA0;</td> <td style="FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: right; FONT-SIZE: 10pt">-</td> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt">&#xA0;</td> </tr> <tr style="BACKGROUND-COLOR: rgb(204,255,204); VERTICAL-ALIGN: bottom"> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; FONT-SIZE: 10pt"> Finished goods</td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; FONT: 10pt Times New Roman, Times, Serif"> 209 <p style="TEXT-ALIGN: center; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> </p> </td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; FONT: 10pt Times New Roman, Times, Serif"> -</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> </tr> <tr style="BACKGROUND-COLOR: white; VERTICAL-ALIGN: bottom"> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 2.5pt; FONT-SIZE: 10pt">Total inventory</td> <td style="PADDING-BOTTOM: 2.5pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 2.5pt double; TEXT-ALIGN: left; FONT: 10pt Times New Roman, Times, Serif"> $</td> <td style="BORDER-BOTTOM: black 2.5pt double; TEXT-ALIGN: right; FONT: 10pt Times New Roman, Times, Serif"> 1,029</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 2.5pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 2.5pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 2.5pt double; TEXT-ALIGN: left; FONT: 10pt Times New Roman, Times, Serif"> $</td> <td style="BORDER-BOTTOM: black 2.5pt double; TEXT-ALIGN: right; FONT: 10pt Times New Roman, Times, Serif"> 279</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 2.5pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> </tr> </table> </div> 32279000 5133000 133000 <div style="FONT: 10pt Times New Roman, Times, Serif"> <p style="MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"><b>NOTE 4 - SUBSEQUENT EVENTS</b></p> <p style="MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <table style="MARGIN-TOP: 0pt; FONT: 10pt Times New Roman, Times, Serif; MARGIN-BOTTOM: 0pt" cellspacing="0" cellpadding="0" width="100%"> <tr style="VERTICAL-ALIGN: top"> <td style="WIDTH: 49.65pt"></td> <td style="WIDTH: 21.25pt"><b>a.</b></td> <td>On July 16, 2012, the Company&#x2019;s Board of Directors approved the grant of 1,500,000 shares of restricted Common Stock to its officers and certain other employees. Of such restricted shares, 1,100,000 of the shares were issued to the Company's named executive officers and vest in 16 equal, quarterly increments over a four-year period, commencing upon the date of grant and are subject to a 24-month lock-up period, commencing upon the applicable vesting dates. Immediately and automatically in the event of a Change in Control, as such term is defined in the Company's 2006 Stock Incentive Plan, as amended, all of the shares of restricted Common Stock issued to the named executive officers shall vest, and the lock-up periods shall terminate, subject to certain exceptions. The remaining 400,000 shares of restricted Common Stock were issued to other employees of the Company and vest in 12 equal, quarterly increments over a three-year period, commencing upon the date of grant. The Company estimated the fair value of the restricted stock on the date of grant to be approximately $8,580,000.</td> </tr> </table> <p style="MARGIN-TOP: 0pt; FONT: 10pt Times New Roman, Times, Serif; MARGIN-BOTTOM: 0pt"> &#xA0;</p> <table style="MARGIN-TOP: 0pt; FONT: 10pt Times New Roman, Times, Serif; MARGIN-BOTTOM: 0pt" cellspacing="0" cellpadding="0" width="100%"> <tr style="VERTICAL-ALIGN: top"> <td style="WIDTH: 49.65pt"></td> <td style="WIDTH: 21.25pt"><font style="COLOR: black"><b>b.</b></font></td> <td>During July 2012, the Company issued a total of 1,000 shares of Common Stock in connection with the exercise of options to purchase 1,000 shares of Common Stock by an employee of the Company. The aggregate cash proceeds in connection with the exercise of the options are equal to approximately $120.</td> </tr> </table> </div> 92670033 1055000 462000 14000 0.04 19391000 26564000 4599000 <div style="FONT: 10pt Times New Roman, Times, Serif"> <p style="TEXT-ALIGN: left; MARGIN: 0pt 0px 0pt 0.75in; FONT: 10pt Times New Roman, Times, Serif"> The weighted average number of shares outstanding used to calculate earnings (loss) per share were as follows:</p> <p style="TEXT-ALIGN: left; MARGIN: 0pt 0px 0pt 0.75in; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <table style="WIDTH: 90%; BORDER-COLLAPSE: collapse; FONT: 10pt Times New Roman, Times, Serif" cellspacing="0" cellpadding="0" align="right"> <tr style="VERTICAL-ALIGN: bottom"> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt; FONT-WEIGHT: bold"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: center; FONT: bold 10pt Times New Roman, Times, Serif" colspan="6">Six Months Ended</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: center; FONT: bold 10pt Times New Roman, Times, Serif" colspan="6">Three Months Ended</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> </tr> <tr style="VERTICAL-ALIGN: bottom"> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt; FONT-WEIGHT: bold"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: center; FONT: bold 10pt Times New Roman, Times, Serif" colspan="2">June 30, 2012</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: center; FONT: bold 10pt Times New Roman, Times, Serif" colspan="2">June 30, 2011</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: center; FONT: bold 10pt Times New Roman, Times, Serif" colspan="2">June 30, 2012</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: center; FONT: bold 10pt Times New Roman, Times, Serif" colspan="2">June 30, 2011</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> </tr> <tr style="BACKGROUND-COLOR: rgb(204,255,204); VERTICAL-ALIGN: bottom"> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; TEXT-INDENT: -17.45pt; PADDING-LEFT: 18.05pt; WIDTH: 34%; FONT-SIZE: 10pt"> Weighted average common shares outstanding for basic calculation</td> <td style="PADDING-BOTTOM: 1pt; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; WIDTH: 11%; FONT: 10pt Times New Roman, Times, Serif"> 89,702,496</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; WIDTH: 11%; FONT: 10pt Times New Roman, Times, Serif"> 83,686,094</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; WIDTH: 11%; FONT: 10pt Times New Roman, Times, Serif"> 91,526,224</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; WIDTH: 11%; FONT: 10pt Times New Roman, Times, Serif"> 85,579,534</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> </tr> <tr style="BACKGROUND-COLOR: white; VERTICAL-ALIGN: bottom"> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; TEXT-INDENT: -17.3pt; PADDING-LEFT: 0.25in; FONT-SIZE: 10pt"> Weighted average dilutive effect of stock options</td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; FONT: 10pt Times New Roman, Times, Serif"> 2,967,537</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; FONT: 10pt Times New Roman, Times, Serif"> -</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; FONT: 10pt Times New Roman, Times, Serif"> 3,354,943</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; FONT: 10pt Times New Roman, Times, Serif"> -</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> </tr> <tr style="BACKGROUND-COLOR: rgb(204,255,204); VERTICAL-ALIGN: bottom"> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; TEXT-INDENT: -17.45pt; PADDING-LEFT: 18.05pt; FONT-SIZE: 10pt"> Weighted average common shares outstanding for diluted calculation</td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; FONT: 10pt Times New Roman, Times, Serif"> 92,670,033</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; FONT: 10pt Times New Roman, Times, Serif"> 83,686,094</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; FONT: 10pt Times New Roman, Times, Serif"> 94,881,167</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; FONT: 10pt Times New Roman, Times, Serif"> 85,579,534</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> </tr> <tr style="BACKGROUND-COLOR: white; VERTICAL-ALIGN: bottom"> <td style="TEXT-ALIGN: left; TEXT-INDENT: -17.3pt; PADDING-LEFT: 0.25in; FONT-SIZE: 10pt"> &#xA0;</td> <td style="FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: right; FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt">&#xA0;</td> <td style="FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: right; FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt">&#xA0;</td> <td style="FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: right; FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt">&#xA0;</td> <td style="FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: right; FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt">&#xA0;</td> </tr> </table> </div> 3000 89702496 750000 2967537 29974000 <div style="FONT: 10pt Times New Roman, Times, Serif"> <p style="MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"><b>NOTE 2 &#x2013; INVENTORIES</b></p> <p style="MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="MARGIN: 0pt 0px 0pt 0.75in; FONT: 10pt Times New Roman, Times, Serif"> Inventory at June 30, 2012 and December&#xA0;31, 2011 consisted of the following:</p> <p style="MARGIN: 0pt 0px 0pt 0.75in; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="MARGIN: 0pt 0px 0pt 0.75in; FONT: 10pt Times New Roman, Times, Serif"> </p> <table style="WIDTH: 85%; BORDER-COLLAPSE: collapse; FONT: 10pt Times New Roman, Times, Serif" cellspacing="0" cellpadding="0" align="center"> <tr style="VERTICAL-ALIGN: bottom"> <td style="TEXT-ALIGN: center; FONT-SIZE: 10pt; FONT-WEIGHT: bold"> &#xA0;</td> <td style="FONT-SIZE: 10pt; FONT-WEIGHT: bold">&#xA0;</td> <td style="TEXT-ALIGN: center; FONT-SIZE: 10pt; FONT-WEIGHT: bold" colspan="2">June 30,</td> <td style="FONT-SIZE: 10pt; FONT-WEIGHT: bold">&#xA0;</td> <td style="FONT-SIZE: 10pt; FONT-WEIGHT: bold">&#xA0;</td> <td style="TEXT-ALIGN: center; FONT-SIZE: 10pt; FONT-WEIGHT: bold" colspan="2">December 31,</td> <td style="FONT-SIZE: 10pt; FONT-WEIGHT: bold">&#xA0;</td> </tr> <tr style="VERTICAL-ALIGN: bottom"> <td style="TEXT-ALIGN: center; FONT-SIZE: 10pt; FONT-WEIGHT: bold"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: center; FONT: 10pt Times New Roman, Times, Serif" colspan="2"> <p style="TEXT-ALIGN: center; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> <b>2012</b></p> </td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: center; FONT: 10pt Times New Roman, Times, Serif" colspan="2"> <p style="TEXT-ALIGN: center; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> <b>2011</b></p> </td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> </tr> <tr style="VERTICAL-ALIGN: bottom"> <td style="FONT-SIZE: 10pt">&#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: center; FONT: 10pt Times New Roman, Times, Serif" colspan="6">(U.S. dollars in thousands)</td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> </tr> <tr style="BACKGROUND-COLOR: rgb(204,255,204); VERTICAL-ALIGN: bottom"> <td style="TEXT-ALIGN: left; WIDTH: 64%; FONT-SIZE: 10pt">Raw materials</td> <td style="WIDTH: 1%; FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: left; WIDTH: 1%; FONT-SIZE: 10pt">$</td> <td style="TEXT-ALIGN: right; WIDTH: 15%; FONT-SIZE: 10pt">731</td> <td style="TEXT-ALIGN: left; WIDTH: 1%; FONT-SIZE: 10pt"> &#xA0;</td> <td style="WIDTH: 1%; FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: left; WIDTH: 1%; FONT-SIZE: 10pt">$</td> <td style="TEXT-ALIGN: right; WIDTH: 15%; FONT-SIZE: 10pt">279</td> <td style="TEXT-ALIGN: left; WIDTH: 1%; FONT-SIZE: 10pt"> &#xA0;</td> </tr> <tr style="BACKGROUND-COLOR: white; VERTICAL-ALIGN: bottom"> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt">Work in progress</td> <td style="FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: right; FONT-SIZE: 10pt">89</td> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt">&#xA0;</td> <td style="FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: right; FONT-SIZE: 10pt">-</td> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt">&#xA0;</td> </tr> <tr style="BACKGROUND-COLOR: rgb(204,255,204); VERTICAL-ALIGN: bottom"> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; FONT-SIZE: 10pt"> Finished goods</td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; FONT: 10pt Times New Roman, Times, Serif"> 209 <p style="TEXT-ALIGN: center; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> </p> </td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; FONT: 10pt Times New Roman, Times, Serif"> -</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> </tr> <tr style="BACKGROUND-COLOR: white; VERTICAL-ALIGN: bottom"> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 2.5pt; FONT-SIZE: 10pt">Total inventory</td> <td style="PADDING-BOTTOM: 2.5pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 2.5pt double; TEXT-ALIGN: left; FONT: 10pt Times New Roman, Times, Serif"> $</td> <td style="BORDER-BOTTOM: black 2.5pt double; TEXT-ALIGN: right; FONT: 10pt Times New Roman, Times, Serif"> 1,029</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 2.5pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 2.5pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 2.5pt double; TEXT-ALIGN: left; FONT: 10pt Times New Roman, Times, Serif"> $</td> <td style="BORDER-BOTTOM: black 2.5pt double; TEXT-ALIGN: right; FONT: 10pt Times New Roman, Times, Serif"> 279</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 2.5pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> </tr> </table> <p style="MARGIN: 0pt 0px 0pt 0.75in; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="MARGIN: 0pt 0px 0pt 0.75in; FONT: 10pt Times New Roman, Times, Serif"> Effective as of the FDA approval of taliglucerase alfa on May 1, 2012, the Company capitalizes all manufacturing costs associated with taliglucerase alfa.</p> </div> 44000 24387000 1780000 3738000 183000 -37000 <div style="FONT: 10pt Times New Roman, Times, Serif"> <table style="MARGIN-TOP: 0pt; FONT: 10pt Times New Roman, Times, Serif; MARGIN-BOTTOM: 0pt" cellspacing="0" cellpadding="0" width="100%"> <tr style="VERTICAL-ALIGN: top"> <td style="WIDTH: 36pt"></td> <td style="WIDTH: 17.85pt"><b>c.</b></td> <td style="PADDING-RIGHT: 81.35pt"><b>Earnings (loss) per share</b></td> </tr> </table> <p style="MARGIN-TOP: 0pt; FONT: 10pt Times New Roman, Times, Serif; MARGIN-BOTTOM: 0pt"> &#xA0;</p> <p style="MARGIN: 0pt 0px 0pt 0.75in; FONT: 10pt Times New Roman, Times, Serif"> Basic earnings (loss) per share are calculated by dividing the net profit (loss) by the weighted average number of shares of the Company's common stock, par value $0.001 (the "Common Stock"), outstanding during each period.</p> <p style="MARGIN: 0pt 0px 0pt 0.75in; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="MARGIN: 0pt 0px 0pt 0.75in; FONT: 10pt Times New Roman, Times, Serif"> Diluted earnings per share are calculated by dividing the net profit by the weighted-average number of shares of common stock outstanding during each period increased to include the number of additional shares of common stock that would have been outstanding if the potentially dilutive shares had been issued. Potentially dilutive shares include outstanding stock options granted to employees and non-employees.</p> <p style="MARGIN: 0pt 0px 0pt 0.75in; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="MARGIN: 0pt 0px 0pt 0.75in; FONT: 10pt Times New Roman, Times, Serif"> </p> <p style="TEXT-ALIGN: left; MARGIN: 0pt 0px 0pt 0.75in; FONT: 10pt Times New Roman, Times, Serif"> The weighted average number of shares outstanding used to calculate earnings (loss) per share were as follows:</p> <p style="TEXT-ALIGN: left; MARGIN: 0pt 0px 0pt 0.75in; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <table style="WIDTH: 90%; BORDER-COLLAPSE: collapse; FONT: 10pt Times New Roman, Times, Serif" cellspacing="0" cellpadding="0" align="right"> <tr style="VERTICAL-ALIGN: bottom"> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt; FONT-WEIGHT: bold"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: center; FONT: bold 10pt Times New Roman, Times, Serif" colspan="6">Six Months Ended</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: center; FONT: bold 10pt Times New Roman, Times, Serif" colspan="6">Three Months Ended</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> </tr> <tr style="VERTICAL-ALIGN: bottom"> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt; FONT-WEIGHT: bold"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: center; FONT: bold 10pt Times New Roman, Times, Serif" colspan="2">June 30, 2012</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: center; FONT: bold 10pt Times New Roman, Times, Serif" colspan="2">June 30, 2011</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: center; FONT: bold 10pt Times New Roman, Times, Serif" colspan="2">June 30, 2012</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: center; FONT: bold 10pt Times New Roman, Times, Serif" colspan="2">June 30, 2011</td> <td style="PADDING-BOTTOM: 1pt; FONT: bold 10pt Times New Roman, Times, Serif"> &#xA0;</td> </tr> <tr style="BACKGROUND-COLOR: rgb(204,255,204); VERTICAL-ALIGN: bottom"> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; TEXT-INDENT: -17.45pt; PADDING-LEFT: 18.05pt; WIDTH: 34%; FONT-SIZE: 10pt"> Weighted average common shares outstanding for basic calculation</td> <td style="PADDING-BOTTOM: 1pt; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; WIDTH: 11%; FONT: 10pt Times New Roman, Times, Serif"> 89,702,496</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; WIDTH: 11%; FONT: 10pt Times New Roman, Times, Serif"> 83,686,094</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; WIDTH: 11%; FONT: 10pt Times New Roman, Times, Serif"> 91,526,224</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; WIDTH: 11%; FONT: 10pt Times New Roman, Times, Serif"> 85,579,534</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; WIDTH: 1%; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> </tr> <tr style="BACKGROUND-COLOR: white; VERTICAL-ALIGN: bottom"> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; TEXT-INDENT: -17.3pt; PADDING-LEFT: 0.25in; FONT-SIZE: 10pt"> Weighted average dilutive effect of stock options</td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; FONT: 10pt Times New Roman, Times, Serif"> 2,967,537</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: left; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="BORDER-BOTTOM: black 1pt solid; TEXT-ALIGN: right; FONT: 10pt Times New Roman, Times, Serif"> -</td> <td style="TEXT-ALIGN: left; PADDING-BOTTOM: 1pt; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</td> <td style="PADDING-BOTTOM: 1pt; 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FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: right; FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt">&#xA0;</td> <td style="FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: right; FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt">&#xA0;</td> <td style="FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: right; FONT-SIZE: 10pt">&#xA0;</td> <td style="TEXT-ALIGN: left; FONT-SIZE: 10pt">&#xA0;</td> </tr> </table> <br style="CLEAR: both" /> <p style="TEXT-ALIGN: left; MARGIN: 0pt 0px 0pt 0.75in; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="TEXT-ALIGN: left; MARGIN: 0pt 0px 0pt 0.75in; FONT: 10pt Times New Roman, Times, Serif"> Diluted earnings (loss) per share do not include options of the Company in the amount of 7,537,094 and 1,785,542 shares of Common Stock for the six months ended June 30, 2011 and 2012, respectively, and 7,435,271 and 1,785,542 shares of Common Stock for the three months ended June 30, 2011 and 2012, respectively, because the effect would be anti-dilutive.</p> </div> 1860000 150000 1357000 15699000 -988000 25478000 2 <div style="FONT: 10pt Times New Roman, Times, Serif"> <table style="MARGIN-TOP: 0pt; FONT: 10pt Times New Roman, Times, Serif; MARGIN-BOTTOM: 0pt" cellspacing="0" cellpadding="0" width="100%"> <tr style="VERTICAL-ALIGN: top"> <td style="WIDTH: 0.5in"></td> <td style="WIDTH: 0.5in"><b>a.</b></td> <td><b>General</b></td> </tr> </table> <p style="MARGIN-TOP: 0pt; FONT: 10pt Times New Roman, Times, Serif; MARGIN-BOTTOM: 0pt"> &#xA0;</p> <table style="MARGIN-TOP: 0pt; FONT: 10pt Times New Roman, Times, Serif; MARGIN-BOTTOM: 0pt" cellspacing="0" cellpadding="0" width="100%"> <tr style="VERTICAL-ALIGN: top"> <td style="WIDTH: 0.75in"></td> <td style="WIDTH: 0.25in"><b>1.</b></td> <td>Operation</td> </tr> </table> <p style="MARGIN-TOP: 0pt; FONT: 10pt Times New Roman, Times, Serif; MARGIN-BOTTOM: 0pt"> &#xA0;</p> <p style="TEXT-INDENT: 0in; MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> Protalix BioTherapeutics, Inc. (collectively with its subsidiaries, the "Company"), and its wholly-owned subsidiary, Protalix Ltd., are biopharmaceutical companies focused on the development and commercialization of recombinant therapeutic proteins based on the Company&#x2019;s proprietary ProCellEx<sup>&#xAE;</sup> protein expression system ("ProCellEx"). In September 2009, Protalix Ltd. formed another wholly-owned subsidiary under the laws of the Netherlands, Protalix B.V., in connection with the European Medicines Agency ("EMA") application process in the European Union. The Company&#x2019;s two subsidiaries are referred to collectively herein as the "Subsidiaries."</p> <p style="TEXT-INDENT: 0in; MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="TEXT-INDENT: 0in; MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> On May 1, 2012, the U.S. Food and Drug Administration (<font style="TEXT-TRANSFORM: uppercase">"</font>FDA<font style="TEXT-TRANSFORM: uppercase">"</font>) approved taliglucerase alfa for injection, the Company&#x2019;s first approved drug product, as an enzyme replacement therapy (ERT) for the long-term treatment of adult patients with a confirmed diagnosis of type 1 Gaucher disease. Taliglucerase alfa is a proprietary, recombinant form of glucocerebrosidase (GCD) that the Company developed using ProCellEx. Taliglucerase alfa is the first FDA-approved plant cell-based recombinant therapeutic protein.</p> <p style="TEXT-INDENT: 0in; MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> Taliglucerase alfa is being marketed in the United States under the brand name ELELYSO&#x2122; by Pfizer Inc. (<font style="TEXT-TRANSFORM: uppercase">"</font>Pfizer<font style="TEXT-TRANSFORM: uppercase">"</font>), the Company's commercialization partner, as provided in the exclusive license and supply agreement by and between Protalix Ltd. and Pfizer (the <font style="TEXT-TRANSFORM: uppercase">"</font>Pfizer Agreement<font style="TEXT-TRANSFORM: uppercase">"</font>). Protalix Ltd. granted Pfizer an exclusive, worldwide license to develop and commercialize taliglucerase alfa under the Pfizer Agreement, but retained those rights in Israel. The Company has agreed to a specific allocation between Protalix Ltd. and Pfizer regarding the responsibilities for the continued development efforts for taliglucerase alfa. To date, the Company has received an upfront payment of $60.0 million in connection with the execution of the Pfizer Agreement and shortly thereafter an additional $5.0 million clinical development-related milestone payment. The Company received an additional $25.0 million milestone payment in connection with the FDA's approval of taliglucerase alfa in the United States, which are recorded as revenues during the current period. The agreement provides that the Company share with Pfizer the net profits or loss related to the development and commercialization of taliglucerase alfa on a 40% and 60% basis, respectively, except with respect to the profits and losses related to commercialization efforts in Israel. <font style="COLOR: black">In calculating the net profits under the agreement, there are certain agreed upon limits on the amounts that may be deducted from gross sales for certain expenses and costs of goods sold</font>.</p> <p style="MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> The Company is cooperating with Pfizer to obtain marketing approval for taligulcerase alfa in additional countries and jurisdictions. Currently, marketing authorization applications have been filed for the European Union, Israel, Brazil and Australia. In June 2012, the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted an opinion recommending against the marketing authorization of taliglucerase alfa in the European Union. While the CHMP gave a positive risk-benefit assessment for taliglucerase alfa, its recommendation was based solely on the orphan market exclusivity granted to VPRIV<sup>&#xAE;</sup>, Shire plc's Gaucher disease treatment. It was not based on the safety and efficacy profile of taliglucerase alfa. The Company and Pfizer are currently working together, along with other interested parties, to determine the next steps regarding the CHMP opinion.</p> <p style="MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> In addition to taliglucerase alfa, the Company is developing certain other products using ProCellEx.</p> <p style="MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"></p> <p style="MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"></p> <p style="TEXT-ALIGN: center; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> </p> <p style="MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> Currently, patients are being treated with taliglucerase alfa on a commercial basis in the United States, and, both within and outside of the United States, through the Company's clinical 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. In July 2009, following a request by the FDA, the Company submitted a treatment protocol to the FDA in order to address an expected shortage of the current enzyme replacement therapy approved for Gaucher disease. The treatment protocol was approved by the FDA in August 2009, and the Company is continuing to treat patients in the United States under this protocol as it winds down with patients being moved to commercial treatment with Elelyso. On July 13, 2010, the Company announced that the French regulatory authority had granted an Autorisation Temporaire d'Utilisation (ATU), or Temporary Authorization for Use, for taliglucerase alfa for the treatment of Gaucher disease. An ATU is the regulatory mechanism used by the French Health Products and Safety Agency to make non-approved drugs available to patients in France when a genuine public health need exists. This ATU allows Gaucher patients in France to receive treatment with taliglucerase alfa before marketing authorization for the product is granted in the European Union. Payment for taliglucerase alfa has been secured through government allocations to hospitals. In addition to the United States and France, taliglucerase alfa is currently being provided to Gaucher patients under special access agreements or named patient provisions in Brazil and in other countries.</p> <p style="MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> On August 10, 2010, Pfizer entered into a short-term supply agreement with the Ministry of Health of Brazil pursuant to which the Company and Pfizer have provided taliglucerase alfa to the Brazilian Ministry of Health for the treatment of Gaucher patients. During the remainder of 2010 and the first quarter of 2011, the Company and Pfizer completed the supply of products deliverable under the short-term supply agreement. During 2011, Pfizer recorded an allowance for sales returns in connection with the supply agreement because the Brazilian Ministry of Health requested that Pfizer consider the replacement of certain vials that might expire during 2012. Revenue, net of allowance for sales returns, generated from the Brazilian Ministry of Health was recorded by Pfizer, and the Company recorded its share of such revenues in accordance with the terms and conditions of the Pfizer Agreement.</p> <p style="MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <table style="MARGIN-TOP: 0pt; FONT: 10pt Times New Roman, Times, Serif; MARGIN-BOTTOM: 0pt" cellspacing="0" cellpadding="0" width="100%"> <tr style="VERTICAL-ALIGN: top"> <td style="WIDTH: 0.75in"></td> <td style="WIDTH: 0.25in"><b>2.</b></td> <td>Liquidity and Financial Resources</td> </tr> </table> <p style="MARGIN-TOP: 0pt; FONT: 10pt Times New Roman, Times, Serif; MARGIN-BOTTOM: 0pt"> &#xA0;</p> <p style="MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> In addition to the FDA approval, successful completion of the Company&#x2019;s development programs and its transition to normal operations is dependent upon obtaining the foreign regulatory approvals required to sell its products internationally. In accordance with the terms and conditions of the Pfizer Agreement, the Company received a $25.0 million milestone payment in connection with the FDA's approval of taliglucerase alfa in the United States. In addition, the Company is eligible to receive potential milestone payments equal to $25.0 million, in the aggregate, for matters relating to the successful achievement of regulatory approval of taliglucerase alfa in the European Union. Notwithstanding the FDA's approval of taliglucerase alfa, there can be no assurance that the Company will receive regulatory approval of taliglucerase alfa in the European Union or any other jurisdiction, nor is there any assurance that the Company will receive regulatory approval of any of its other product candidates, and a substantial amount of time may pass before the Company achieves a level of revenues adequate to support its operations, if at all. The Company also expects to incur substantial expenditures in connection with the regulatory approval process for each of its product candidates during their respective developmental periods. Obtaining marketing approval with respect to any product candidate is directly dependent on the Company&#x2019;s ability to implement the necessary regulatory steps required to obtain such approval in the United States and in other countries. The Company cannot reasonably predict the outcome of these activities.</p> <p style="MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> </p> <p style="MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> &#xA0;</p> <p style="MARGIN: 0pt 0px 0pt 1in; FONT: 10pt Times New Roman, Times, Serif"> </p> <p style="MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"></p> <p style="TEXT-ALIGN: center; MARGIN: 0pt 0px; FONT: 10pt Times New Roman, Times, Serif"> </p> <p style="TEXT-ALIGN: left; MARGIN-TOP: 0px; TEXT-INDENT: 0in; FONT: 10pt Times New Roman, Times, Serif; MARGIN-BOTTOM: 0px; MARGIN-LEFT: 0.75in"> Based on its current cash resources and commitments, the Company believes it will be able to maintain its current planned development activities and the corresponding level of expenditures for at least the next 12 months, although no assurance can be given that it will not need additional funds prior to such time. If there are unexpected increases in general and administrative expenses or research and development expenses, the Company may need to seek additional financing during the next 12 months.</p> </div> 3692000 2445000 1314000 1117249 5000 1000 5175000 3738000 3759000 25383000 1054000 25000000 5000000 1785542 1117249 1055000 25388000 1780000 1100000 P4Y 16 24 400000 P3Y 12 1000 120 -13868000 -0.16 1799000 85579534 -0.16 8768000 132000 85579534 764000 -4750000 -13689000 179000 7319000 -5382000 1449000 152000 127000 7435271 9620000 0.10 3504000 94881167 0.11 10544000 3279000 91526224 3354943 26113000 21979000 9642000 22000 8855000 -855000 1689000 2384000 1246000 3500000 P3Y 1785542 60000000 0001006281 2009-11-30 2012-06-30 0001006281 us-gaap:StockOptionsMember 2012-04-01 2012-06-30 0001006281 us-gaap:PerformanceSharesMember 2012-04-01 2012-06-30 0001006281 us-gaap:GeneralAndAdministrativeExpenseMember 2012-04-01 2012-06-30 0001006281 us-gaap:ResearchAndDevelopmentExpenseMember 2012-04-01 2012-06-30 0001006281 2012-04-01 2012-06-30 0001006281 us-gaap:StockOptionsMember 2011-04-01 2011-06-30 0001006281 us-gaap:GeneralAndAdministrativeExpenseMember 2011-04-01 2011-06-30 0001006281 us-gaap:ResearchAndDevelopmentExpenseMember 2011-04-01 2011-06-30 0001006281 2011-04-01 2011-06-30 0001006281 plx:EmployeeMemberplx:OptionExerciseMember 2012-07-01 2012-07-31 0001006281 us-gaap:RestrictedStockMemberplx:EmployeesMemberus-gaap:StockCompensationPlanMember 2012-07-01 2012-07-31 0001006281 us-gaap:RestrictedStockMemberus-gaap:ExecutiveOfficerMemberus-gaap:StockCompensationPlanMember 2012-07-01 2012-07-31 0001006281 2012-02-01 2012-02-29 0001006281 plx:EmployeeAndNonEmployeeMember 2012-01-01 2012-06-30 0001006281 us-gaap:StockOptionsMember 2012-01-01 2012-06-30 0001006281 plx:ScenarioTwoMember 2012-01-01 2012-06-30 0001006281 plx:ScenarioOneMember 2012-01-01 2012-06-30 0001006281 us-gaap:AdditionalPaidInCapitalMember 2012-01-01 2012-06-30 0001006281 us-gaap:RetainedEarningsMember 2012-01-01 2012-06-30 0001006281 us-gaap:CommonStockMember 2012-01-01 2012-06-30 0001006281 us-gaap:GeneralAndAdministrativeExpenseMember 2012-01-01 2012-06-30 0001006281 us-gaap:ResearchAndDevelopmentExpenseMember 2012-01-01 2012-06-30 0001006281 2012-01-01 2012-06-30 0001006281 us-gaap:StockOptionsMember 2011-01-01 2011-06-30 0001006281 us-gaap:AdditionalPaidInCapitalMember 2011-01-01 2011-06-30 0001006281 us-gaap:RetainedEarningsMember 2011-01-01 2011-06-30 0001006281 us-gaap:CommonStockMember 2011-01-01 2011-06-30 0001006281 us-gaap:GeneralAndAdministrativeExpenseMember 2011-01-01 2011-06-30 0001006281 us-gaap:ResearchAndDevelopmentExpenseMember 2011-01-01 2011-06-30 0001006281 2011-01-01 2011-06-30 0001006281 us-gaap:AdditionalPaidInCapitalMember 2011-12-31 0001006281 us-gaap:RetainedEarningsMember 2011-12-31 0001006281 us-gaap:CommonStockMember 2011-12-31 0001006281 2011-12-31 0001006281 us-gaap:AdditionalPaidInCapitalMember 2010-12-31 0001006281 us-gaap:RetainedEarningsMember 2010-12-31 0001006281 us-gaap:CommonStockMember 2010-12-31 0001006281 2010-12-31 0001006281 plx:ProtalixBioTherapeuticsIncorporationMember 2012-06-30 0001006281 plx:PfizerIncorporationMember 2012-06-30 0001006281 us-gaap:AdditionalPaidInCapitalMember 2012-06-30 0001006281 us-gaap:RetainedEarningsMember 2012-06-30 0001006281 us-gaap:CommonStockMember 2012-06-30 0001006281 2012-06-30 0001006281 us-gaap:AdditionalPaidInCapitalMember 2011-06-30 0001006281 us-gaap:RetainedEarningsMember 2011-06-30 0001006281 us-gaap:CommonStockMember 2011-06-30 0001006281 2011-06-30 0001006281 us-gaap:RestrictedStockMemberus-gaap:StockCompensationPlanMember 2012-07-16 0001006281 us-gaap:RestrictedStockMemberus-gaap:ExecutiveOfficerMemberus-gaap:StockCompensationPlanMember 2012-07-16 0001006281 2012-07-30 0001006281 2012-02-22 shares iso4217:USD shares iso4217:USD pure plx:Entity plx:Installment plx:Month Includes share-based compensation 2,445 256 2,384 152 Includes share-based compensation 1,314 265 1,246 127 Common Stock, $0.001 par value; Authorized - as of June 30, 2012 and June 30, 2011 - 150,000,000 shares.