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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
 Washington, D.C. 20549
 
 FORM 10-Q
 
 (Mark One)
 þ
    
    QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 For the quarterly period ended March 31, 2009
 OR
 o
    
    TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 For the transition period from  to
 001-33357
(Commission file number)
 PROTALIX BIOTHERAPEUTICS, INC.
 (Exact name of registrant as specified in its charter)
 
 Florida
    
    65-0643773(State or other jurisdiction
    
    (I.R.S. Employerof incorporation or organization)
    
    Identification No.)2 Snunit StreetScience ParkPOB 455Carmiel, Israel
    
    20100(Address of principal executive offices)
    
    (Zip Code)
 972-4-988-9488  (Registrants telephone number, including area code)
 Securities registered pursuant to Section 12(b) of the Act:
 Title of each class
    
    Name of each exchange on which registeredCommon stock, par value $0.001 per share
    
    NYSE Amex
 þ o
 o o
  Large accelerated filer o
    
    Accelerated filer þ
    
    Non-accelerated filer   o
(Do not check if a smaller reporting company)
    
    Smaller reporting company o
 o þ




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##### 



FORM 10-Q
TABLE OF CONTENTS
 PagePART I  FINANCIAL INFORMATIONCautionary Statement Regarding Forward-Looking Statements
    
    iiItem 1. Financial StatementsCondensed Consolidated Balance Sheets  As of March 31, 2009 (Unaudited) and December 31, 2008
    
    
    1Condensed Consolidated Statements of Operations (Unaudited)  For the Three Months Ended March 31, 2009 and 2008; and for the Period from December 27, 1993 through March 31, 2009
    
    
    2Condensed Consolidated Statement of Changes in Shareholders Equity  As of March 31, 2009 (Unaudited) and December 31, 2008
    
    
    3Condensed Consolidated Statements of Cash Flows (Unaudited)  For the Three Months Ended March 31, 2009 (Unaudited) and 2008; and for the Period from December 27, 1993 through March 31, 2009
    
    
    4Notes to Condensed Consolidated Financial Statements
    
    
    6Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
    
    
    9Item 3. Quantitative and Qualitative Disclosures About Market Risk
    
    
    12Item 4. Controls and Procedures
    
    
    13PART II  OTHER INFORMATIONItem 1. Legal Proceedings
    
    
    15Item 1A. Risk Factors
    
    
    15Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
    
    
    15Item 3. Defaults Upon Senior Securities
    
    
    15Item 4. Submission of Matters to a Vote of Security Holders
    
    
    15Item 5. Other Information
    
    
    15Item 6. Exhibits
    
    
    16Signatures
    
    
    17iEX-31.1EX-31.2EX-32.1EX-32.2




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Except where the context otherwise requires, the terms, we, us, our or the Company, refer
to the business of Protalix BioTherapeutics, Inc. and its consolidated subsidiaries, and Protalix
or Protalix Ltd. refers to the business of Protalix Ltd., our wholly-owned subsidiary and sole
operating unit.
 
 CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
   
    
    the inherent risks and uncertainties in developing drug platforms and products of
the type we are developing;
    
    delays in our preparation and filing of applications for regulatory approval;
    
    delays in the approval or potential rejection of any applications we file with the
United States Food and Drug Administration, or the FDA, or other regulatory
authorities;
    
    any lack of progress of our research and development (including the results of
clinical trials we are conducting);
    
    obtaining on a timely basis sufficient patient enrollment in our clinical trials;
    
    the impact of development of competing therapies and/or technologies by other
companies;
    
    our ability to obtain additional financing required to fund our research programs;
    
    the risk that we will not be able to develop a successful sales and marketing
organization in a timely manner, if at all;
    
    our ability to establish and maintain strategic license, collaboration and
distribution arrangements and to manage our relationships with collaborators,
distributors and partners;
    
    potential product liability risks and risks of securing adequate levels of product
liability and clinical trial insurance coverage;
    
    the availability of reimbursement to patients from health care payors for any of our
drug products, if approved;
    
    the possibility of infringing a third partys patents or other intellectual property
rights;
    
    the uncertainty of obtaining patents covering our products and processes and in
successfully enforcing our intellectual property rights against third parties; and
    
    the possible disruption of our operations due to terrorist activities and armed
conflict, including as a result of the disruption of the operations of regulatory
authorities, our subsidiary, our manufacturing facilities and our customers, suppliers,
distributors, collaborative partners, licensees and clinical trial sites.
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PART I  FINANCIAL INFORMATION
 
 Item 1. Financial Statements
 PROTALIX BIOTHERAPEUTICS, INC.
 
 CONDENSED CONSOLIDATED BALANCE SHEETS
  March 31, 2009
    
    
    December 31, 2008(Unaudited)ASSETSCURRENT ASSETS:Cash and cash equivalents
    
    $
    34,911
    
    
    $
    42,596Accounts receivable
    
    
    2,390
    
    
    
    793Total current assets
    
    
    37,301
    
    
    
    43,389FUNDS IN RESPECT OF EMPLOYEE
RIGHTS UPON RETIREMENT
    
    
    554
    
    
    
    581PROPERTY AND EQUIPMENT, NET
    
    
    8,383
    
    
    
    6,841Total assets
    
    $
    46,238
    
    
    $
    50,811LIABILITIES AND SHAREHOLDERS EQUITYCURRENT LIABILITIES:Accounts payable and accruals:Trade
    
    $
    1,707
    
    
    $
    2,235Other
    
    
    3,986
    
    
    
    3,292Total current liabilities
    
    
    5,693
    
    
    
    5,527LIABILITY FOR EMPLOYEE RIGHTS
UPON RETIREMENT
    
    
    917
    
    
    
    937Total liabilities
    
    
    6,610
    
    
    
    6,464SHAREHOLDERS EQUITY
    
    
    39,628
    
    
    
    44,347Total liabilities and shareholders equity
    
    $
    46,238
    
    
    $
    50,811
 The accompanying notes are an integral part of the condensed consolidated financial statements.
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PROTALIX BIOTHERAPEUTICS, INC.
 
 CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
   Period from December27, 1993*Three Months Ended
    
    
    throughMarch 31, 2009
    
    
    March 31, 2008
    
    
    March 31, 2009REVENUES
    
    
    
    
    
    
    
    
    
    $
    830COST OF REVENUES
    
    
    
    
    
    
    
    
    
    
    206GROSS PROFIT
    
    
    
    
    
    
    
    
    
    
    624RESEARCH AND DEVELOPMENT EXPENSES (1)
    
    $
    5,086
    
    
    $
    5,653
    
    
    
    59,503less  grants
    
    
    (1,292
    )
    
    
    (1,366
    )
    
    
    (12,193
    )3,794
    
    
    
    4,287
    
    
    
    47,310GENERAL AND ADMINISTRATIVE EXPENSES (2)
    
    
    1,241
    
    
    
    1,976
    
    
    
    37,601OPERATING LOSS
    
    
    5,035
    
    
    
    6,263
    
    
    
    84,287FINANCIAL EXPENSES ( INCOME)  NET
    
    
    148
    
    
    
    (1,150
    )
    
    
    (4,057
    )NET LOSS BEFORE CHANGE IN
ACCOUNTING PRINCIPLE
    
    
    5,183
    
    
    
    5,113
    
    
    
    80,230CUMULATIVE EFFECT OF
CHANGE IN ACCOUNTING PRINCIPLE
    
    
    
    
    
    
    
    
    
    
    (37
    )NET LOSS FOR THE PERIOD
    
    $
    5,183
    
    
    $
    5,113
    
    
    $
    80,193NET LOSS PER SHARE OF COMMON STOCK 
BASIC AND DILUTED:
    
    $
    0.07
    
    
    $
    0.07WEIGHTED AVERAGE NUMBER OF SHARES OF
COMMON STOCK USED IN COMPUTING LOSS PER
SHARE:Basic and diluted
    
    
    75,947,708
    
    
    
    75,811,866(1) Includes share-based compensation
    
    $
    278
    
    
    $
    1,327
    
    
    $
    6,888(2) Includes share-based compensation
    
    
    184
    
    
    
    847
    
    
    
    23,029
 
 *
    
    Incorporation date, see Note 1a. The accompanying notes are an integral part of the condensed consolidated financial statements.
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PROTALIX BIOTHERAPEUTICS, INC.
 
 CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS EQUITY
  DeficitaccumulatedConvertible
    
    
    
    
    
    
    Convertible
    
    
    
    
    
    
    Additional
    
    
    duringCommon
    
    
    Preferred
    
    
    Common
    
    
    Preferred
    
    
    
    
    
    
    paid-in
    
    
    developmentStock (2)
    
    
    Shares
    
    
    Stock
    
    
    Shares
    
    
    Warrants
    
    
    capital
    
    
    stage
    
    
    TotalNumber of shares
    
    
    AmountBalance at December 27, 1993(1)
Changes during the period from December
27, 1993 through December 31, 2008:Common Stock and convertible preferred
A, B and C shares and warrants issued
for cash (net of issuance costs of
$5,078)
    
    
    38,856,127
    
    
    
    398,227
    
    
    $
    39
    
    
    $
    1
    
    
    $
    1,382
    
    
    $
    73,836
    
    
    
    
    
    
    $
    75,258Exercise of options granted to
employees and non-employees (includes
Net Exercise)
    
    
    2,948,420
    
    
    
    847
    
    
    
    3
    
    
    
    
    
    
    
    
    
    
    
    413
    
    
    
    
    
    
    
    416Conversion of convertible preferred
shares into common stock
    
    
    24,375,870
    
    
    
    (399,074
    )
    
    
    24
    
    
    
    (1
    )
    
    
    
    
    
    
    (23
    )Change in accounting principle
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    (37
    )
    
    $
    37Expiration of warrants
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    (34
    )
    
    
    34Merger with a wholly-owned subsidiary
of the Company (net of issuance cost of
$642)
    
    
    583,280
    
    
    
    
    
    
    
    1
    
    
    
    
    
    
    
    
    
    
    
    240
    
    
    
    
    
    
    
    241Exercise of warrants
    
    
    9,171,695
    
    
    
    
    
    
    
    9
    
    
    
    
    
    
    
    (1,348
    )
    
    
    15,342
    
    
    
    
    
    
    
    14,003Restricted common stock issued for
future services
    
    
    2,667
    
    
    
    
    
    
    
    *
    
    
    
    
    
    
    
    
    
    
    
    8
    
    
    
    
    
    
    
    8Share-based compensation
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    29,468
    
    
    
    
    
    
    
    29,468Net loss for the period
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    (75,047
    )
    
    
    (75,047
    )Balance at December 31, 2008
    
    
    75,938,059
    
    
    
    
    
    
    
    76
    
    
    
    
    
    
    
    
    
    
    
    119,281
    
    
    
    (75,010
    )
    
    
    44,347Changes during the three month period
ended March 31, 2009(Unaudited):Share-based compensation
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    462
    
    
    
    
    
    
    
    462Exercise of options granted to employees
(includes Net Exercise)
    
    
    35,068
    
    
    
    
    
    
    
    *
    
    
    
    
    
    
    
    
    
    
    
    2
    
    
    
    
    
    
    
    2Net loss for the period
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    (5,183
    )
    
    
    (5,183
    )Balance at March 31, 2009(Unaudited)
    
    
    75,973,127
    
    
    
    
    
    
    $
    76
    
    
    
    
    
    
    
    
    
    
    $
    119,745
    
    
    $
    (80,193
    )
    
    $
    39,628
 
 (1)
    
    Incorporation date, see Note 1a.(2)
    
    Common Stock, $0.001 par value; Authorized  as of December 31, 2008 and March 31, 2009 -
150,000,000 shares.*
    
    Represents an amount less than $1. The accompanying notes are an integral part of the condensed consolidated financial statements.
 3




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PROTALIX BIOTHERAPEUTICS, INC.
 
 CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
   Period fromDecember 27, 1993*Three Months Ended
    
    
    throughMarch 31, 2009
    
    
    March 31, 2008
    
    
    March 31, 2009CASH FLOWS FROM OPERATING ACTIVITIES:Net loss for the period
    
    $
    (5,183
    )
    
    $
    (5,113
    )
    
    $
    (80,193
    )Adjustments required to reconcile net loss to net
cash used in operating activities:
    
    
    
    
    
    
    
    
    
    
    Cumulative effect of change in accounting principle
    
    
    
    
    
    
    
    
    
    
    (37
    )Share based compensation
    
    
    462
    
    
    
    2,174
    
    
    
    29,917Financial expenses (income), net (mainly exchange
differences)
    
    
    235
    
    
    
    (580
    )
    
    
    (841
    )Depreciation and impairment of fixed assets
    
    
    455
    
    
    
    262
    
    
    
    3,695Changes in accrued liability for employee rights
upon retirement
    
    
    69
    
    
    
    182
    
    
    
    1,006Gain on amounts funded in respect of employee rights
upon retirement
    
    
    (7
    )
    
    
    (41
    )
    
    
    (72
    )Gain on sale of fixed assets
    
    
    (28
    )
    
    
    
    
    
    
    (34
    )Changes in operating assets and liabilities:Increase in accounts receivable
    
    
    (1,642
    )
    
    
    (658
    )
    
    
    (2,151
    )Increase (decrease) in accounts payable and
accruals
    
    
    (343
    )
    
    
    (33
    )
    
    
    4,039Net cash used in operating activities
    
    $
    (5,982
    )
    
    $
    (3,807
    )
    
    $
    (44,671
    )CASH FLOWS FROM INVESTING ACTIVITIES:Purchase of property and equipment
    
    $
    (1,305
    )
    
    $
    (817
    )
    
    $
    (10,498
    )Investment grant received in respect of fixed assets
    
    
    
    
    
    
    
    
    
    
    38Investment in restricted cash deposit
    
    
    
    
    
    
    
    
    
    
    (222
    )Proceeds from sale of property and equipment
    
    
    61
    
    
    
    
    
    
    
    73Amounts funded in respect of employee rights upon
retirement, net
    
    
    (20
    )
    
    
    (39
    )
    
    
    (536
    )Net cash used in investing activities
    
    $
    (1,264
    )
    
    $
    (856
    )
    
    $
    (11,145
    )CASH FLOWS FROM FINANCING ACTIVITIES:Loan and convertible bridge loan received
    
    
    
    
    
    
    
    
    
    $
    2,145Repayment of loan
    
    
    
    
    
    
    
    
    
    
    (1,000
    )Issuance of shares and warrants, net of issuance cost
    
    
    
    
    
    $
    (20
    )
    
    
    74,059Exercise of options and warrants
    
    
    
    
    
    $
    3
    
    
    
    14,419Merger with a wholly-owned subsidiary of the
Company, net of issuance cost
    
    
    
    
    
    
    
    
    
    
    237Net cash provided by (used in) financing activities
    
    
    
    
    
    $
    (17
    )
    
    $
    89,860EFFECT OF EXCHANGE RATE CHANGES
ON CASH
    
    $
    (439
    )
    
    $
    649
    
    
    $
    867NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
    
    
    (7,685
    )
    
    
    (4,031
    )
    
    
    34,911BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF
PERIOD
    
    
    42,596
    
    
    
    61,183
    
    
    
    BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD
    
    $
    34,911
    
    
    $
    57,782
    
    
    $
    34,911
 The accompanying notes are an integral part of the condensed consolidated financial statements.
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PROTALIX BIOTHERAPEUTICS, INC.   CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
  Period fromDecember 27,1993*Three Months Ended
    
    
    throughMarch 31, 2009
    
    
    March 31, 2008
    
    
    March 31, 2009SUPPLEMENTARY DISCLOSURE OF
CASH FLOW INFORMATION:Cash paid during the period for interest
    
    
    
    
    
    
    
    
    
    $
    80SUPPLEMENTARY INFORMATION
ON INVESTING AND FINANCING
ACTIVITIES NOT INVOLVING CASH FLOWS:Conversion of convertible bridge loan into shares
    
    
    
    
    
    
    
    
    
    $
    1,145Purchase of property and equipment
    
    $
    1,657
    
    
    $
    1,009
    
    
    $
    1,657Issuance cost not yet paid and accruals  other:
    
    $
    5
    
    
    $
    41
    
    
    $
    5Exercise of options granted to employees
    
    $
    2
    
    
    
    
    
    
    $
    2Issuance cost paid by a grant of options
    
    
    
    
    
    
    
    
    
    $
    21Consultants and director credit balance
converted into shares
    
    
    
    
    
    
    
    
    
    $
    80
 
 *
    
    Incorporation date, see Note 1a. The accompanying notes are an integral part of the condensed consolidated financial statements.
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PROTALIX BIOTHERAPEUTICS, INC.
 
 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
   NOTE 1  SIGNIFICANT ACCOUNTING POLICIES
 a.
    
    General
 1.
    
    OperationProtalix BioTherapeutics, Inc. (the Company), and
Protalix Ltd., the Companys wholly-owned subsidiary which was incorporated in Israel on December 27, 1993 (Protalix Ltd.), are biopharmaceutical companies focused on the
development and commercialization of recombinant therapeutic proteins based on the
Companys proprietary ProCellExtm protein expression system
(ProCellEx). The Companys lead product development candidate is prGCD for the
treatment of Gaucher disease, which the Company is developing using its ProCellEx
protein expression system. The Company is currently treating patients in a phase
III clinical trial of prGCD.The Company has been in the development stage since its inception.  Successful completion of
development program and its transition to normal operations is dependent upon
necessary regulatory approvals from the United States Food and Drug Administration
(the FDA) prior to selling its products within the United States, and foreign
regulatory approvals must be obtained to sell its products internationally. There
can be no assurance that the Company will receive regulatory approval of any of its
product candidates, and a substantial amount of time may pass before the Company
achieves a level of sales adequate to support the Companys operations, if at all.
The Company will also incur substantial expenditures in connection with the
regulatory approval process and may need to raise additional capital during the
developmental period. Obtaining marketing approval will be directly dependent on
the Companys ability to implement the necessary regulatory steps required to obtain
marketing approval in the United States and in other countries, and on the success
of the Companys clinical trials. The Company cannot predict the outcome of these
activities.
 2.
    
    Liquidity and Financial ResourcesThe Company currently does not have sufficient resources to complete the
commercialization of any of its proposed products. 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 approximately the next 21 months, although no assurance can be given that it
will not need additional cash prior to such time. If there are unexpected increases
in general and administrative expenses and research and development expenses, the
Company may need to seek additional financing during the next 21 months.
 b.
    
    General Basis of Presentation
 The accompanying unaudited condensed consolidated financial statements of the
Company have been prepared in accordance with generally accepted accounting
principles in the United States (GAAP) for interim financial information,
Statement of Financial Accounting Standards (SFAS) No. 7, Accounting and
Reporting by Development Stage Enterprises, and Article 10 of Regulation S-X under
the Securities Exchange Act of 1934. Accordingly, they do not include all of the
information and notes required by GAAP for complete 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.
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PROTALIX BIOTHERAPEUTICS, INC.   NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
 NOTE 1  SIGNIFICANT ACCOUNTING POLICIES (Continued):
 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, 2008, filed by the Company with the
Securities and Exchange Commission. The comparative balance sheet at December 31,
2008 has been derived from the audited financial statements at that date, but does
not include all of the information and notes required under GAAP for complete
financial statements.
 c.
    
    Net loss per share
 Basic and diluted loss per share (LPS) are computed by dividing net loss by the
weighted average number of shares of the Companys common stock, par value $.001 per
share (the Common Stock) outstanding for each period.Shares of restricted Common Stock and the shares of Common Stock underlying
outstanding options of the Company were not included in the calculation of diluted
LPS because the effect would be anti-dilutive.Diluted LPS does not include options and restricted shares of Common Stock of the
Company in the amount of 10,565,151 and 11,418,079 shares of Common Stock for the
three months ended March 31, 2008 and 2009, respectively.
 NOTE 2  STOCK TRANSACTIONS
 a.
    
    During the three months ended March 31, 2009, the Company issued 35,068 shares
of Common Stock in connection with the exercise of a total of 52,978 options by certain
officers and employees of the Company. The Company received aggregate cash proceeds
equal to approximately $2 in connection with such exercises and 39,800 of such options
were exercised on a net-exercise basis.b.
    
    In February 25, 2009, the Companys board of directors approved the grant of
options to purchase 624,400 shares of Common Stock to its officers and employees with
an exercise price equal to $2.65 per share. The options vest as follows:
  
 
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PROTALIX BIOTHERAPEUTICS, INC.   NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
 NOTE 3  COMMITMENTS
 During the three months ended March 31, 2009, the Company entered into contracts with
certain third parties in connection with certain clinical services. The aggregate fees
payable by the Company during the life of the agreements are equal to approximately
$650,000.
 NOTE 4  SUBSEQUENT EVENTS
 During April and May 2009, the Company issued a total of 182,612 shares of Common Stock in
connection with the exercise of options to purchase 188,430 shares of Common Stock by a
certain officer and employees of the Company. The Company received aggregate cash proceeds
equal to approximately $6 in connection with such exercises and 137,530 of such options were
exercised on a net-exercise basis.
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Item 2. Managements Discussion and Analysis of Financial Condition and Results of
Operations
 You should read the following discussion and analysis of our financial condition and results
of operations together with our condensed financial statements and the consolidated financial
statements and the related notes included elsewhere in this Form 10-Q and our Annual Report on Form
10-K for the year ended December 31, 2008. Some of the information contained in this discussion
and analysis, particularly with respect to our plans and strategy for our business and related
financing, includes forward-looking statements that involve risks and uncertainties. You should
read Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2008 for a
discussion of important factors that could cause actual results to differ materially from the
results described in or implied by the forward-looking statements contained in the following
discussion and analysis.
 Overview
 tm
    9




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Critical Accounting Policies
   Results of Operations
 Three months ended March 31, 2009 compared to the three months ended March 31, 2008
 Research and Development Expenses
  10




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General and Administrative Expenses
  Financial Expenses and Income
  Liquidity and Capital Resources
 Sources of Liquidity
  Cash Flows
   Future Funding Requirements
  11




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Effects of Inflation and Currency Fluctuations
   Off-Balance Sheet Arrangements
  
 Item 3. Quantitative and Qualitative Disclosures About Market Risk
 Currency Exchange Risk
  12




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##### Table of Contents



Three months ended
    
    Year endedMarch 31,
    
    December 31,2009
    
    2008
    
    2008Average rate for period
    
    
    4.0585
    
    
    
    3.6234
    
    
    
    3.5878Rate at period end
    
    
    4.1880
    
    
    
    3.5530
    
    
    
    3.8020
  Interest Rate Risk
  
 Item 4. Controls and Procedures
 Evaluation of Disclosure Controls and Procedures
   13




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##### Table of Contents



Inherent Limitations on Effectiveness of Controls
  Changes in internal controls
  14




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##### Table of Contents



PART II  OTHER INFORMATION
 
 Item 1. Legal Proceedings
  
 Item 1A. Risk Factors
  
 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
 Unregistered Sales of Equity Securities
  Use of Proceeds
    
 Item 3. Defaults Upon Senior Securities
  
 Item 4. Submission of Matters to a Vote of Security Holders
  
 Item 5. Other Information
  15




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##### Table of Contents



Item 6. Exhibits
 ExhibitNumber
    
    Exhibit Description
    
    Method of Filing3.1
    
    Amended and Restated Articles of
Incorporation of the Company
    
    Incorporated by
reference to the
Companys
Registration
Statement on Form
S-4 filed on March
26, 1998, SEC File
No. 333-486773.2
    
    Article of Amendment to Articles
of Incorporation dated 
June 9,
2006
    
    Incorporated by
reference to the
Companys
Registration
Statement on Form
8-A filed on March
9, 20073.3
    
    Article of Amendment to Articles
of Incorporation dated December
13, 2006
    
    Incorporated by
reference to the
Companys
Registration
Statement on Form
8-A filed on March
9, 20073.4
    
    Article of Amendment to Articles
of Incorporation dated December
26, 2006
    
    Incorporated by
reference to the
Companys
Registration
Statement on Form
8-A filed on March
9, 20073.5
    
    Article of Amendment to Articles
of Incorporation dated February
26, 2007
    
    Incorporated by
reference to the
Companys
Registration
Statement on Form
8-A filed on March
9, 20073.6
    
    Bylaws of the Company, as amended
    
    Incorporated by
reference to the
Companys Quarterly
Report on 10-Q for
the quarter ended
June 30, 2008,
filed on August 8,
200831.1
    
    Certification of Chief Executive
Officer pursuant to Rule
13a-14(a) as adopted pursuant to
Section 302 of the
Sarbanes-Oxley Act of 2002
    
    Filed herewith31.2
    
    Certification of Chief Financial
Officer pursuant to Rule
13a-14(a) as adopted pursuant to
Section 302 of the
Sarbanes-Oxley Act of 2002
    
    Filed herewith32.1
    
    18 U.S.C. Section 1350, as
adopted pursuant to Section 906
of the Sarbanes-Oxley Act of
2002, Certification of Chief
Executive Officer
    
    Filed herewith32.2
    
    18 U.S.C. Section 1350, as
adopted pursuant to Section 906
of the Sarbanes-Oxley Act of
2002, Certification of Chief
Financial Officer
    
    Filed herewith
 16




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##### Table of Contents



SIGNATURES
  PROTALIX BIOTHERAPEUTICS, INC.
                      (Registrant)Date: May 10, 2009
    By:
    /s/ David AviezerDavid Aviezer, Ph.D.President and Chief Executive Officer
(Principal Executive Officer)Date: May 10, 2009
    By:
    /s/ Yossi MaimonYossi MaimonChief Financial Officer, Treasurer and Secretary
(Principal Financial and Accounting Officer) 17