10-Q
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2008
OR
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o |
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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)
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Florida
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65-0643773 |
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(State or other jurisdiction
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(I.R.S. Employer |
of incorporation or organization)
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Identification No.) |
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2 Snunit Street |
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Science Park |
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POB 455
Carmiel, Israel
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20100 |
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(Address of principal executive offices)
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(Zip Code) |
972-4-988-9488
(Registrants telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Name of each exchange on which registered |
Common stock, par value $0.001 per share
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American Stock Exchange |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
a non-accelerated filer, or a smaller reporting company.
See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
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Large accelerated filer o |
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Accelerated filer þ |
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Non-accelerated filer o
(Do not check if a smaller reporting company) |
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Smaller reporting company o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act). Yes o No þ
On August 1, 2008, approximately 75,930,235 shares of the Registrants common stock, $0.001
par value, were outstanding.
FORM 10-Q
TABLE OF CONTENTS
i
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 statements set forth under the captions Business, Managements Discussion and Analysis of
Financial Condition and Results of Operations, and Risk Factors, and other statements included
elsewhere in this Annual Report on Form 10-Q, which are not historical, constitute forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the
expectations, beliefs, intentions or strategies for the future. When used in this report, the
terms anticipate, believe, estimate, expect and intend and words or phrases of similar
import, as they relate to our or our subsidiary or our management, are intended to identify
forward-looking statements. We intend that all forward-looking statements be subject to the
safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. These
forward-looking statements are only predictions and reflect our views as of the date they are made
with respect to future events and financial performance, and we undertake no obligation to update
any forward-looking statement to reflect events or circumstances after the date on which the
statement is made or to reflect the occurrence of unanticipated events, except as may be required
under applicable law. Forward-looking statements are subject to many risks and uncertainties that
could cause our actual results to differ materially from any future results expressed or implied by
the forward-looking statements.
Examples of the risks and uncertainties include, but are not limited to, the following:
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the inherent risks and uncertainties in developing drug platforms and products of
the type we are developing; |
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delays in our preparation and filing of applications for regulatory approval; |
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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; |
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any lack of progress of our research and development (including the results of
clinical trials we are conducting); |
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obtaining on a timely basis sufficient patient enrollment in our clinical trials; |
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the impact of development of competing therapies and/or technologies by other
companies; |
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our ability to obtain additional financing required to fund our research programs; |
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the risk that we will not be able to develop a successful sales and marketing
organization in a timely manner, if at all; |
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our ability to establish and maintain strategic license, collaboration and
distribution arrangements and to manage our relationships with collaborators,
distributors and partners; |
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potential product liability risks and risks of securing adequate levels of product
liability and clinical trial insurance coverage; |
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the availability of reimbursement to patients from health care payors for our drug
products, if approved; |
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the possibility of infringing a third partys patents or other intellectual property
rights; |
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the uncertainty of obtaining patents covering our products and processes and in
successfully enforcing them against third parties; |
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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; and |
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other risks and uncertainties detailed in Section 1A of this Quarterly Report. |
In addition, companies in the pharmaceutical and biotechnology industries have suffered significant
setbacks in advanced clinical trials, even after obtaining promising earlier trial results. These
and other risks and uncertainties are detailed in Section 1A of our Annual Report on Form 10-K for
the year ended December 31, 2007, and described from time to time in our future reports to be filed
with the Securities and Exchange Commission. We undertake no obligation to update, and we do not
have a policy of updating or revising, these forward-looking statements.
ii
PART I FINANCIAL INFORMATION
Item 1. Financial Statements
PROTALIX BIOTHERAPEUTICS, INC.
(a development stage company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share data)
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June 30, 2008 |
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December 31, 2007 |
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(Unaudited) |
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ASSETS |
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CURRENT ASSETS: |
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Cash and cash equivalents |
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$ |
53,360 |
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$ |
61,813 |
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Accounts receivable |
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1,920 |
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1,354 |
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Total current assets |
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55,280 |
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63,167 |
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FUNDS IN RESPECT OF EMPLOYEE
RIGHTS UPON RETIREMENT |
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626 |
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464 |
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PROPERTY AND EQUIPMENT, NET |
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5,914 |
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4,506 |
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Total assets |
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$ |
61,820 |
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$ |
68,137 |
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LIABILITIES AND SHAREHOLDERS EQUITY |
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CURRENT LIABILITIES: |
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Accounts payable and accruals: |
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Trade |
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$ |
1,714 |
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$ |
899 |
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Other |
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2,626 |
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2,863 |
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Total current liabilities |
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4,340 |
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3,762 |
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LIABILITY FOR EMPLOYEE RIGHTS
UPON RETIREMENT |
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967 |
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690 |
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Total liabilities |
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5,307 |
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4,452 |
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SHAREHOLDERS EQUITY |
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56,513 |
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63,685 |
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Total liabilities and shareholders equity |
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$ |
61,820 |
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$ |
68,137 |
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The accompanying notes are an integral part of the condensed consolidated financial statements.
1
PROTALIX BIOTHERAPEUTICS, INC.
(a development stage company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share data)
(Unaudited)
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Period from |
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December 27, 1993* |
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Six Months Ended |
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Three Months Ended |
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through |
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June 30, 2008 |
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June 30, 2007 |
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June 30, 2008 |
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June 30, 2007 |
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June 30, 2008 |
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REVENUES |
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$ |
830 |
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COST OF REVENUES |
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206 |
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GROSS PROFIT |
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624 |
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RESEARCH AND DEVELOPMENT EXPENSES (1) |
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$ |
9,684 |
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$ |
5,707 |
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$ |
4,031 |
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$ |
3,175 |
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41,277 |
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less grants |
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(2,515 |
) |
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(1,081 |
) |
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(1,149 |
) |
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(343 |
) |
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(8,702 |
) |
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7,169 |
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4,626 |
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2,882 |
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2,832 |
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32,575 |
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GENERAL AND ADMINISTRATIVE EXPENSES (2) |
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3,992 |
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8,490 |
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2,016 |
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6,503 |
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24,694 |
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OPERATING LOSS |
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11,161 |
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13,116 |
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4,898 |
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9,335 |
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56,645 |
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FINANCIAL INCOME NET |
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(1,819 |
) |
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(506 |
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(669 |
) |
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(175 |
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(4,267 |
) |
OTHER INCOME |
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(6 |
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(6 |
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(6 |
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NET LOSS BEFORE CHANGE IN
ACCOUNTING PRINCIPLE |
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9,342 |
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12,604 |
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4,229 |
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9,154 |
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52,372 |
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CUMULATIVE EFFECT OF
CHANGE IN ACCOUNTING PRINCIPLE |
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(37 |
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NET LOSS FOR THE PERIOD |
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$ |
9,342 |
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$ |
12,604 |
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$ |
4,229 |
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$ |
9,154 |
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$ |
52,335 |
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NET LOSS PER SHARE OF COMMON STOCK
BASIC AND DILUTED: |
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$ |
0.12 |
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$ |
0.19 |
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$ |
0.06 |
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$ |
0.14 |
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WEIGHTED AVERAGE NUMBER OF SHARES OF
COMMON STOCK USED IN COMPUTING LOSS PER
SHARE: |
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Basic and diluted |
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75,855,594 |
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65,032,809 |
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75,898,295 |
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65,657,181 |
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(1) Includes share-based compensation |
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672 |
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1,084 |
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(655 |
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878 |
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5,347 |
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(2) Includes share-based compensation |
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1,495 |
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7,001 |
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648 |
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5,756 |
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13,601 |
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* |
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Incorporation date, see Note 1a. |
The accompanying notes are an integral part of the condensed consolidated financial statements.
2
PROTALIX BIOTHERAPEUTICS, INC.
(a development stage company)
CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS EQUITY
(U.S. dollars in thousands, except share data)
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Deficit |
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accumulated |
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Convertible |
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Convertible |
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Additional |
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during |
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Common |
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Preferred |
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Common |
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Preferred |
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paid-in |
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development |
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Stock (2) |
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Shares |
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Stock |
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Shares |
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Warrants |
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capital |
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stage |
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Total |
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Number of shares |
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Amount |
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Balance at December 27, 1993(1)
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Changes during the period from
December 27, 1993 through December
31, 2007: |
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Common Stock and convertible
preferred A, B and C shares and
warrants issued for cash (net of
issuance costs of $5,078) |
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38,856,127 |
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|
398,227 |
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$ |
39 |
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|
$ |
1 |
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|
$ |
1,382 |
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$ |
73,836 |
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$ |
75,258 |
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Exercise of options granted to
employees and non-employees |
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2,780,467 |
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|
847 |
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3 |
|
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|
408 |
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|
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|
411 |
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Conversion of convertible preferred
shares into common stock |
|
|
24,375,870 |
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(399,074 |
) |
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24 |
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(1 |
) |
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(23 |
) |
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Change in accounting principle |
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(37 |
) |
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$ |
37 |
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Expiration of warrants |
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(34 |
) |
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34 |
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Merger with a wholly owned
subsidiary of the Company (net of
issuance cost of $642) |
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|
583,280 |
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|
1 |
|
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|
|
|
|
|
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|
240 |
|
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|
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|
241 |
|
Exercise of warrants |
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|
9,171,695 |
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9 |
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(1,348 |
) |
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|
15,342 |
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|
14,003 |
|
Restricted common stock issued for
future services |
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|
8,000 |
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* |
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|
11 |
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|
11 |
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Share-based compensation |
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|
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16,791 |
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|
16,791 |
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Net loss for the period |
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(43,030 |
) |
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(43,030 |
) |
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Balance at December 31, 2007 |
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|
75,775,439 |
|
|
|
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|
76 |
|
|
|
|
|
|
|
|
|
|
|
106,602 |
|
|
|
(42,993 |
) |
|
|
63,685 |
|
Changes during the six month period
ended June 30, 2008 (Unaudited): |
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
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|
|
|
|
|
|
|
|
Restricted common stock issued for
future services |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5 |
) |
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|
|
|
|
|
(5 |
) |
Share-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,172 |
|
|
|
|
|
|
|
2,172 |
|
Exercise (includes Net Exercise) of
options granted to employees |
|
|
154,796 |
|
|
|
|
|
|
|
* |
|
|
|
|
|
|
|
|
|
|
|
3 |
|
|
|
|
|
|
|
3 |
|
Net loss for the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(9,342 |
) |
|
|
(9,342 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2008 (Unaudited) |
|
|
75,930,235 |
|
|
|
|
|
|
$ |
76 |
|
|
|
|
|
|
|
|
|
|
$ |
108,772 |
|
|
$ |
(52,335 |
) |
|
$ |
56,513 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Incorporation date, see Note 1a. |
|
(2) |
|
Common Stock, $0.001 par value; Authorized as of December 31, 2007 and June 30, 2008 -
150,000,000 shares. |
|
* |
|
Represents an amount less than $1. |
The accompanying notes are an integral part of the condensed consolidated financial statements.
3
PROTALIX BIOTHERAPEUTICS, INC.
(a development stage company)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S. dollars in thousands, except share data)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
|
December 27, 1993* |
|
|
|
Six Months Ended |
|
|
through |
|
|
|
June 30, 2008 |
|
|
June 30, 2007 |
|
|
June 30, 2008 |
|
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss for the period |
|
$ |
(9,342 |
) |
|
$ |
(12,604 |
) |
|
$ |
(52,335 |
) |
Adjustments required to reconcile net loss to net
cash used in operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative effect of change in accounting principle |
|
|
|
|
|
|
|
|
|
|
(37 |
) |
Share based compensation |
|
|
2,167 |
|
|
|
8,085 |
|
|
|
18,948 |
|
Financial income net (principal differences relate
to currency transaction gains/losses) |
|
|
(916 |
) |
|
|
47 |
|
|
|
(1,722 |
) |
Depreciation and impairment of fixed assets |
|
|
582 |
|
|
|
277 |
|
|
|
2,521 |
|
Changes in accrued liability for employee rights
upon retirement |
|
|
277 |
|
|
|
127 |
|
|
|
967 |
|
Gain on amounts funded in respect of employee rights
upon retirement |
|
|
(81 |
) |
|
|
(8 |
) |
|
|
(185 |
) |
Gain on sale of fixed assets |
|
|
|
|
|
|
(6 |
) |
|
|
(6 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Increase in accounts receivable |
|
|
(388 |
) |
|
|
(963 |
) |
|
|
(1,533 |
) |
Increase in accounts payable and accruals |
|
|
254 |
|
|
|
156 |
|
|
|
3,261 |
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
$ |
(7,447 |
) |
|
$ |
(4,889 |
) |
|
$ |
(30,121 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of property and equipment |
|
$ |
(1,904 |
) |
|
$ |
(809 |
) |
|
$ |
(7,726 |
) |
Investment grant received in respect of fixed assets |
|
|
|
|
|
|
|
|
|
|
38 |
|
Investment in restricted cash deposit |
|
|
|
|
|
|
|
|
|
|
(47 |
) |
Proceeds from sale of property and equipment |
|
|
|
|
|
|
10 |
|
|
|
11 |
|
Amounts funded in respect of employee rights upon
retirement |
|
|
(81 |
) |
|
|
(59 |
) |
|
|
(612 |
) |
Amounts paid in respect of employee rights upon
retirement |
|
|
|
|
|
|
14 |
|
|
|
171 |
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
$ |
(1,985 |
) |
|
$ |
(844 |
) |
|
$ |
(8,165 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
|
|
|
Loan and convertible bridge loan received |
|
|
|
|
|
|
|
|
|
$ |
2,145 |
|
Repayment of loan |
|
|
|
|
|
|
|
|
|
|
(1,000 |
) |
Issuance of shares and warrants, net of issuance cost |
|
|
(56 |
) |
|
$ |
12,910 |
|
|
|
74,059 |
|
Exercise of options and warrants |
|
$ |
3 |
|
|
|
|
|
|
|
14,417 |
|
Merger with a wholly owned subsidiary of the
Company, net of issuance cost |
|
|
|
|
|
|
(39 |
) |
|
|
237 |
|
|
|
|
|
|
|
|
|
|
|
Net cash (used) provided by financing activities |
|
$ |
(53 |
) |
|
$ |
12,871 |
|
|
$ |
89,858 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EFFECT OF EXCHANGE RATE CHANGES
ON CASH |
|
$ |
1,032 |
|
|
$ |
(27 |
) |
|
$ |
1,788 |
|
|
|
|
|
|
|
|
|
|
|
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS |
|
|
(8,453 |
) |
|
|
7,111 |
|
|
|
53,360 |
|
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF
PERIOD |
|
|
61,813 |
|
|
|
15,378 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD |
|
$ |
53,360 |
|
|
$ |
22,489 |
|
|
$ |
53,360 |
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of the condensed consolidated financial statements.
4
PROTALIX BIOTHERAPEUTICS, INC.
(a development stage company)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S. dollars in thousands, except share data)
(Unaudited)
(Continued) 2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
|
December 27, |
|
|
|
|
|
|
|
|
|
|
|
1993* |
|
|
|
Six Months Ended |
|
|
through |
|
|
|
June 30, 2008 |
|
|
June 30, 2007 |
|
|
June 30, 2008 |
|
SUPPLEMENTARY DISCLOSURE OF
CASH FLOW INFORMATION: |
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid during the period for interest |
|
|
|
|
|
|
|
|
|
$ |
80 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTARY INFORMATION
ON INVESTING AND FINANCING
ACTIVITIES NOT INVOLVING CASH FLOWS: |
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of convertible bridge loan into shares |
|
|
|
|
|
|
|
|
|
$ |
1,145 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of property and equipment |
|
$ |
752 |
|
|
$ |
451 |
|
|
$ |
752 |
|
|
|
|
|
|
|
|
|
|
|
Issuance cost not yet paid and accruals other: |
|
$ |
5 |
|
|
$ |
5 |
|
|
$ |
5 |
|
|
|
|
|
|
|
|
|
|
|
Issuance cost paid by a grant of options |
|
|
|
|
|
|
|
|
|
$ |
21 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Consultants and director credit balance converted
into shares |
|
|
|
|
|
|
|
|
|
$ |
80 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Merger with a wholly owned subsidiary of
the Company |
|
|
|
|
|
|
|
|
|
|
|
|
Issuance cost setoff against accounts payable |
|
|
|
|
|
$ |
65 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
Incorporation date, see Note 1a. |
The accompanying notes are an integral part of the condensed consolidated financial statements.
5
PROTALIX BIOTHERAPEUTICS, INC.
(a development stage company)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share data)
(Unaudited)
NOTE 1 SIGNIFICANT ACCOUNTING POLICIES
|
1. |
|
Operation |
|
|
|
|
Protalix BioTherapeutics, Inc. and its wholly-owned subsidiary, Protalix Ltd.
(collectively, the Company), are biopharmaceutical companies focused on the
development and commercialization of recombinant therapeutic proteins based on the
Companys proprietary ProCellExtm protein expression system
(ProCellEx). The Companys 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 enrolling and treating patients
in a phase III clinical trial of prGCD, and has initiated an extension study in
connection with the trial for patients that have completed the trial and chose to
continue the treatment. |
|
|
|
|
The Company has been in the development stage since its inception. The Companys
successful completion of its development program and its transition to normal
operations is dependent upon the Companys receipt of necessary regulatory approvals
from the United States Food and Drug Administration (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 Companys
products will receive regulatory approvals, and a substantial amount of time may
pass before the Company achieves a level of sales adequate to support the Companys
operations, if at all. The Company will also incur substantial expenditures in
connection with the regulatory approval process and it might need to raise
additional capital during the developmental period. Obtaining marketing approval
will be directly dependent on the Companys ability to implement the necessary
regulatory steps required to obtain marketing approval in the United States and
other countries and the success of the Companys clinical trials. The Company
cannot predict the outcome of these activities. |
|
|
2. |
|
Liquidity and Financial Resources |
|
|
|
|
The 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 at least the next 24 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, capital expenditures and research and
development expenses, the Company may need to seek additional financing during the
next 24 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. These unaudited
condensed consolidated financial statements should be read in |
6
PROTALIX BIOTHERAPEUTICS, INC.
(a development stage company)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share data)
(Unaudited)
NOTE 1 SIGNIFICANT ACCOUNTING POLICIES (Continued)
|
|
|
conjunction with the audited consolidated financial statements in the Annual Report
on Form 10-K for the year ended December 31, 2007, filed by the Company with the
Securities and Exchange Commission (the Commission). The comparative balance
sheet at December 31, 2007 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. |
|
|
|
Basic and diluted loss per share (LPS) are computed by dividing net loss by the
weighted average number of shares of the Companys 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 and warrants 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, restricted shares of Common Stock and warrants
of the Company in the amount of 12,404,378 and 10,883,292 shares of Common Stock for
the six months ended June 30, 2007 and 2008, respectively, and 11,801,505 and
11,181,138 shares of Common Stock for the three months ended June 30, 2007 and 2008,
respectively. |
|
d. |
|
Newly issued Accounting Pronouncements |
|
1. |
|
In December 2007, the Financial Accounting Standards Board (the FASB)
issued SFAS No. 141 (revised 2007), Business Combinations (SFAS 141(R)). SFAS
141(R) changes the accounting for business combinations, including the measurement
of acquirer shares issued in consideration for a business combination, the
recognition of contingent consideration, the accounting for contingencies, the
recognition of capitalized in-process research and development, the accounting for
acquisition-related restructuring cost accruals, the treatment of acquisition
related transaction costs and the recognition of changes in the acquirers income
tax valuation allowance and income tax uncertainties. SFAS 141(R) applies
prospectively to business combinations for which the acquisition date is on or
after the beginning of the first annual reporting period beginning on or after
December 15, 2008. Early application is prohibited. The Company will be required
to adopt SFAS 141(R) on January 1, 2009. |
|
|
2. |
|
In December 2007, the FASB issued SFAS No. 160, Noncontrolling
Interests in Consolidated Financial Statements, an Amendment of ARB No. 51 (SFAS
160). SFAS 160 amends ARB 51 to establish accounting and reporting standards for
the noncontrolling interest in a subsidiary and for the deconsolidation of a
subsidiary. Ownership interests in subsidiaries held by parties other than the
parent company of the subsidiary are required to be presented in the consolidated
statement of financial position within equity, but separate from the parent
companys equity. SFAS 160 requires that changes in a parent companys ownership
interest while the parent company retains its controlling financial interest in its
subsidiary should be accounted for in a manner similar to the accounting treatment
of equity transactions. When a subsidiary is deconsolidated, any retained
noncontrolling equity investment in the former subsidiary should be initially
measured at fair value, with any gain or loss recognized in earnings. SFAS 160
requires consolidated net income to be reported in amounts that include the amounts
attributable to both the parent company and the noncontrolling interest. It also
requires disclosure, on the face of the consolidated income statement, of the
amounts of consolidated net income attributable to both parent companies and the
noncontrolling interests. |
7
PROTALIX BIOTHERAPEUTICS, INC.
(a development stage company)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share data)
(Unaudited)
NOTE 1 SIGNIFICANT ACCOUNTING POLICIES (Continued)
|
|
|
SFAS 160 is effective for fiscal years (including interim periods within those
fiscal years) beginning on or after December 15, 2008. Earlier adoption is
prohibited. SFAS 160 is required to be applied prospectively as of the beginning of
the fiscal year in which it is initially applied, except for the presentation and
disclosure requirement which shall be applied retrospectively for all periods
presented. The Company is required to adopt SFAS 160 as of January 1, 2009. The
Company is currently assessing the impact that SFAS 160 may have on its results of
operations and financial position. |
|
|
3. |
|
In December 2007, the FASB ratified EITF Issue No. 07-01, Accounting
for Collaborative Arrangements (EITF 07-01). EITF 07-01 defines collaborative
arrangements and establishes reporting requirements for transactions between
participants in a collaborative arrangement and between participants in the
arrangement and third parties. EITF 07-01 also establishes the appropriate income
statement presentation and classification for joint operating activities and
payments between participants, as well as the sufficiency of the disclosures
related to these arrangements. EITF 07-01 is effective for fiscal years beginning
after December 15, 2008 (January 1, 2009, for the Company). Companies are required
to apply EITF 07-01 using a modified version of retrospective transition for those
arrangements in place at the effective date. In addition, companies are required
to report the effects of the application of EITF 07-01 as a change in accounting
principle through retrospective application to all prior periods presented for all
arrangements existing as of the effective date, unless it is impracticable to apply
the effects of the change retrospectively. The Company is currently assessing the
impact that EITF 07-01 may have on its results of operations and financial
position. |
|
|
4. |
|
In March 2008, the FASB issued SFAS No. 161, Disclosures about
Derivative Instruments and Hedging Activities (SFAS 161). SFAS 161 is intended
to improve financial reporting regarding derivative instruments and hedging
activities by requiring enhanced disclosure to enable investors to better
understand the effects of such derivative instruments and hedging activities on a
companys financial position, financial performance and cash flows. SFAS 161 is
effective for financial statements issued for fiscal years and interim periods
beginning after November 15, 2008, with early application encouraged (January 1,
2009, for the Company). SFAS 161 also improves transparency regarding the location
and amounts of derivative instruments in a companys financial statements; how
derivative instruments and related hedged items are accounted for under Statement
of Financial Accounting Standards No. 133 Accounting for Derivative Instruments
and Hedging Activities; and how derivative instruments and related hedged items
affect a companys financial position, financial performance and cash flows. The
Company is currently evaluating the effect SFAS 161 will have on its financial
statement presentations. |
|
|
5. |
|
In May 2008, the FASB issued SFAS No. 162, The Hierarchy of Generally
Accepted Accounting Principles (SFAS 162). The statement is intended to improve
financial reporting by identifying a consistent hierarchy for selecting accounting
principles to be used in preparing financial statements that are presented in
conformity with U.S. generally accepted accounting principles (GAAP). SFAS 162
will go into effect 60 days following the Commissions approval of the Public
Company Accounting Oversight Board Auditing amendments to AU Section 411 The
Meaning of Present Fairly in Conformity with Generally Accepted Accounting
Principles. The Company does not expect the adoption of SFAS 162 to have a
material impact on its results of operations and financial position. |
8
PROTALIX BIOTHERAPEUTICS, INC.
(a development stage company)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share data)
(Unaudited)
NOTE 1 SIGNIFICANT ACCOUNTING POLICIES (Continued)
|
e. |
|
Reclassifications |
|
|
|
|
Certain figures in respect of prior years have been reclassified to conform with the
current year presentation. |
NOTE 2 STOCK TRANSACTIONS
|
a. |
|
During the three months ended June 30, 2008, the Company issued 154,796 shares
of Common Stock in connection with the exercise of 189,460 options by certain officers
and employees of the Company. The Company received cash proceeds equal to $3 in
connection with such exercises as 167,440 of such options were exercised on a
net-exercise basis. |
|
|
b. |
|
On February 7, 2008, the Companys board of directors approved the grant of
options to purchase 50,000 shares of Common Stock to a newly appointed member of the
Companys board of directors, at an exercise price of $3.02 per share. The options
vest over a four-year period and are exercisable for a 10-year period commencing on the
date of grant. |
|
|
|
|
The Company estimated the fair value of the options on the date of the grant using the
Black-Scholes option-pricing model to be approximately $109, based on the following
assumptions: dividend yield of 0% for all years; expected volatility of 62.5%; risk-free
interest rates of 2.9%; and expected life of 10 years. |
|
|
c. |
|
On February 7, 2008, the Companys board of directors approved the grant of
options to purchase 1,900,000 shares of Common Stock, in the aggregate, to certain
officers and employees of the Company, at an exercise price of $5.00 per share. The
options vest variably over periods of up to five years and are exercisable for a
10-year period commencing on the date of grant. |
|
|
|
|
The Company estimated the fair value of the options on the date of the grant using the
Black-Scholes option-pricing model to be approximately $2,766, based on the following
assumptions: dividend yield of 0% for all years; expected volatility of 62.5%; risk-free
interest rates of 2.9%; and expected life of six years. |
|
|
d. |
|
In February 2008, the Company amended the stock option agreements of certain
executive officers. As amended, such stock option agreements provide for the full
acceleration of the vesting period of unvested options held by such officers
immediately upon a change of control. The Company concluded that the amendments do not
result in a modification accounting charge against share-based compensation. |
NOTE 3 COMMITMENTS
|
a. |
|
In January 2008, the Company entered into a lease agreement for the expansion
of its current facility. The term of the lease is 7.5 years, commencing upon the date
the newly-leased space is ready for occupancy by the Company, with three options for
additional five-year periods, for a total of 15 additional years. The monthly rental
payment is approximately $25 and is subject to increase based on certain improvements
to be performed by the lessor. |
9
PROTALIX BIOTHERAPEUTICS, INC.
(a development stage company)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share data)
(Unaudited)
NOTE 3 COMMITMENTS (Continued)
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b. |
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During the quarter ended June 30, 2008, the Company entered into contracts with
certain third parties in connection with certain clinical services. In accordance with
the terms and conditions of such agreements, commencement of the services will begin in
the quarter ending September 30, 2008. The aggregate fees payable by the Company
during the life of the agreements are equal to approximately $400. |
NOTE 4 FAIR VALUE
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On January 1, 2008, the Company adopted the methods of fair value as described in SFAS
No. 157 (SFAS 157), which defines fair value, establishes a framework for measuring fair
value in accordance with GAAP and expands disclosure about fair value measurements to value
its financial assets and liabilities. As defined in SFAS No. 157, fair value is based on
the price that would be received to sell an asset or paid to transfer a liability in an
orderly transaction between market participants at the measurement date. In order to
increase consistency and comparability in fair value measurements, SFAS No. 157 establishes
a fair value hierarchy that prioritizes observable and unobservable inputs used to measure
fair value into three broad levels, which are described as follows: |
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Level 1: Quoted prices (unadjusted) in active markets that are accessible at the
measurement date for assets or liabilities. The fair value hierarchy gives the
highest priority to Level 1 inputs. |
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Level 2: Observable prices that are based on inputs not quoted on active markets,
but corroborated by market data. |
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Level 3: Unobservable inputs are used when little or no market data is available.
The fair value hierarchy gives the lowest priority to Level 3 inputs. |
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The adoption of SFAS 157 did not have a material impact on the Companys results of
operations and financial condition as the Company does not have any financial assets and
liabilities measured at fair value on a recurring basis subject to the requirements of SFAS
157 except money market funds in the amount of approximately $43,000 included in cash
equivalents and classified as
level 1. |
NOTE 5 SUBSEQUENT EVENT
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During July 2008, the Company entered into contracts with certain third parties in
connection with certain clinical services. In accordance with the terms and conditions of
such agreements, commencement of the services will begin in the quarter ending September 30,
2008. The aggregate fees payable by the Company during the life of the agreements are equal
to approximately $900. |
10
Item 2. Managements 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, 2007. 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, 2007 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
We are a biopharmaceutical company focused on the development and commercialization of
recombinant therapeutic proteins based on our proprietary ProCellExtm protein expression
system. Using our ProCellEx system, we are developing a pipeline of proprietary recombinant
therapeutic proteins based on our plant cell-based expression technology that target large,
established pharmaceutical markets and that rely upon known biological mechanisms of action. Our
initial commercial focus has been on complex therapeutic proteins, including proteins for the
treatment of genetic disorders, such as Gaucher disease and Fabry disease, and on female
infertility disorders. We believe our ProCellEx protein expression system will enable us to
develop proprietary recombinant proteins that are therapeutically equivalent or superior to
existing recombinant proteins currently marketed for the same indications. Because we are
targeting biologically equivalent versions of highly active, well-tolerated and commercially
successful therapeutic proteins, we believe our development process is associated with relatively
less risk compared to other biopharmaceutical development processes for completely novel
therapeutic proteins.
Our lead product development candidate is prGCD for the treatment of Gaucher disease, which we
are developing using our ProCellEx protein expression system. In July 2007, we reached an
agreement with the United States Food and Drug Administration, or the FDA, on the final design of
our pivotal phase III clinical trial of prGCD, through the FDAs special protocol assessment (SPA)
process. We initiated enrollment and treatment of patients in our phase III clinical trial of
prGCD in the third quarter of 2007. During third quarter of, 2008, we initiated a double-blind,
follow-on extension study as part of our phase III clinical trial. prGCD is our proprietary
recombinant form of Glucocerebrosidase (GCD), an enzyme naturally found in human cells that is
mutated or deficient in patients with Gaucher disease. The current standard of care for Gaucher
disease is enzyme replacement therapy, a medical treatment in which the GCD enzyme is injected into
patients in whom the enzyme is lacking or dysfunctional. Although Gaucher disease is a relatively
rare disease, it represents a large commercial market due to the severity of the symptoms and the
chronic nature of the disease. The annual worldwide sales of Cerezyme, an enzyme replacement
therapy produced by Genzyme Corporation and currently the only approved enzyme replacement therapy
for Gaucher disease, were approximately $1.1 billion in 2007, and $624 million for the six months
ended June 30, 2008, according to public reports by Genzyme. prGCD is a plant cell expressed
version of the GCD enzyme, developed through our ProCellEx protein expression system. prGCD has an
amino acid, glycan and three-dimensional structure that is very similar to its naturally-produced
counterpart as well as to Cerezyme, the mammalian cell expressed version of the same protein. We
believe prGCD may prove more cost-effective than the currently marketed alternative due to the cost
benefits of expression through our ProCellEx protein expression system. In addition, based on our
laboratory testing, preclinical and clinical results, we believe that prGCD may have the potential
for increased potency and efficacy compared to the existing enzyme replacement therapy for Gaucher
disease, which may translate into lower dosages and/or less frequent treatments.
In addition to prGCD, we are developing an innovative product pipeline using our ProCellEx
protein expression system, including therapeutic protein candidates for the treatment of Fabry
disease, a rare, genetic lysosomal disorder in humans, and for female infertility disorders. We
are also developing an acetylcholinesterase enzyme-based therapy for biodefense and intoxication
treatments. We plan to file an investigational new drug application (IND) with the FDA with
respect to at least one additional product by the end of 2008 or early 2009. We believe that we
may be able to reduce the development risks and time to market for our product candidates as our
product candidates are based on well-understood proteins with known biological mechanisms of
actions. We hold the worldwide commercialization rights to our proprietary development candidates
and we intend to establish an
11
internal, commercial infrastructure and targeted sales force to
market prGCD and our other products, if approved, in North America, the European Union and in other
significant markets, including Israel.
Our business is conducted by our wholly owned subsidiary, Protalix Ltd., which we acquired
through a reverse merger transaction effective December 31, 2006. The merger transaction was
treated as a recapitalization for accounting purposes and, as such, the results of operations
discussed below are those of Protalix Ltd. Prior to the merger transaction, we had not conducted
any operations for several years. Protalix Ltd. was originally incorporated in Israel in December
1993. Since its inception in December 1993, Protalix Ltd. has generated significant losses in
connection with its research and development, including the clinical development of prGCD. At June
30, 2008, we had an accumulated deficit of $52.3 million. Since we do not generate revenue from
any of our product candidates, we expect to continue to generate losses in connection with the
continued clinical development of prGCD and the research and development activities relating to our
technology and other drug candidates. Such research and development activities are budgeted to
expand over time and will require further resources if we are to be successful. As a result, we
believe that our operating losses are likely to be substantial over the next several years. We
will need to obtain additional funds for the commercialization of our lead product, prGCD, and to
further develop the research and clinical development of our other programs.
Critical Accounting Policies
Our significant accounting policies are described in Note 1 to our condensed consolidated
financial statements appearing at the beginning of this Quarterly Report on Form 10-Q.
Results of Operations
Three months ended June 30, 2008 compared to the three months ended June 30, 2007
Research and Development Expenses
Research and development expenses were $4.0 million for the three months ended June 30, 2008,
an increase of $856,000, or 27%, from $3.2 million for the three months ended June 30, 2007. The
increase resulted from the increase of $763,000 in payments to consultants and subcontractors
associated with research and development. Such increase is mainly due to the costs incurred by us
in connection with our phase III clinical trial of prGCD, which we commenced during the third
quarter of 2007. The increase was partially offset by grants of $1.1 million from the Office of
the Chief Scientist, or the OCS, during the three months ended June 30, 2008, an increase of
approximately $806,000 compared to grants equal to $343,000 received from the OCS during the three
months ended June 30, 2007.
We expect research and development expenses to continue to increase as we enter into a more
advanced stage of clinical trials for our product candidates, especially with respect to the
anticipated continued progress in our phase III clinical trial of prGCD and with the extension
study that we initiated in the third quarter of 2008 for patients that have completed such trial
and chose to continue the treatment.
General and Administrative Expenses
General and administrative expenses were $2.0 million for the three months ended June 30,
2008, a decrease of $4.5 million, or approximately 69%, from $6.5 million for the three months
ended June 30, 2007. The decrease resulted primarily from a $5.1 million decrease in share-based
compensation resulting from the decrease in the fair value of the common stock underlying the
portions of certain outstanding stock options granted to consultants that vested during the
three-month period ended June 30, 2008.
Financial Expenses and Income
Financial income was $669,000 for the three months ended June 30, 2008, an increase of
$494,000 or approximately 282%, from $175,000 for the three months ended June 30, 2007. The
increase resulted primarily from a higher balance of cash and cash equivalents as of June 30, 2008,
which primarily resulted from the interest
12
income earned on the proceeds generated from our
underwritten public offering in October 2007 and from the devaluation of the Dollar against the New
Israeli Shekel, or NIS.
Six months ended June 30, 2008 compared to the six months ended June 30, 2007
Research and Development Expenses
Research and development expenses were $9.7 million for the six months ended June 30, 2008, an
increase of $4.0 million, or 70%, from $5.7 million for the six months ended June 30, 2007. The
increase resulted primarily from the increase of $3.2 million in salaries for new and existing
employees and related consulting and the costs of materials associated with research and
development. The increase was partially offset by grants of $2.5 million from the OCS, during the
six months ended June 30, 2008, an increase of approximately $1.4 million compared to grants equal
to $1.1 million received from the OCS during the six months ended June 30, 2007.
We expect research and development expenses to continue to increase as we enter into a more
advanced stage of clinical trials for our product candidates, especially with respect to our phase
III clinical trial of prGCD and with the extension study that we initiated in the third quarter of
2008 for patients that have completed such trial and chose to continue the treatment.
General and Administrative Expenses
General and administrative expenses were $4.0 million for the six months ended June 30, 2008,
a decrease of $4.5 million, or approximately 53%, from $8.5 million for the six months ended June
30, 2007. The decrease resulted primarily from a $5.5 million decrease in share-based compensation
resulting from the decrease in the fair value of the shares of common stock underlying the portions
of certain outstanding stock options granted to consultants that vested during the six-month period
ended June 30, 2008. The decrease was partially set off by the increase of $455,000 in salaries
and related expenses.
Financial Expenses and Income
Financial income was $1.8 million for the six months ended June 30, 2008, an increase of $1.3
million, or approximately 259%, from $506,000 for the six months ended June 30, 2007. The increase
resulted primarily from a higher balance of cash and cash equivalents as of June 30, 2008, which
primarily resulted from the interest income earned on the proceeds generated from our underwritten
public offering in October 2007 and from the devaluation of the Dollar against the NIS.
Liquidity and Capital Resources
Sources of Liquidity
As a result of our significant research and development expenditures and the lack of any
approved products to generate product sales revenue, we have not been profitable and have generated
operating losses since our inception. To date, we have funded our operations primarily with
proceeds equal to $31.3 million from the private sale of our shares of common stock and from sales
of convertible preferred and ordinary shares of Protalix Ltd., and an additional $14.4 million in
connection with the exercise of warrants issued in connection with the sale of such ordinary
shares, through December 31, 2007. In addition, on October 25, 2007, we generated gross proceeds
of $50 million in connection with an underwritten public offering of our common stock. We believe
that the funds currently available to us as are sufficient to satisfy our capital needs for the
next 24 months.
Cash Flows
Net cash used in operations was $7.4 million for the six months ended June 30, 2008. The net
loss for the six months ended June 30, 2008 of $9.3 million was partially offset by $2.2 million of
non-cash share-based compensation. Net cash used in investing activities for the six months ended
June 30, 2008 was $2.0 and consisted primarily of purchases of property and equipment. Net cash
used in financing activities for the six months ended
13
June 30, 2008 was $53,000, consisting of
expenses paid during such period in connection with the October 2007 underwritten offering.
Net cash used in operations was $4.9 million for the six months ended June 30, 2007. The net
loss for the six months ended June 30, 2007 of $12.6 million was partially offset by $8.1 million
of non-cash share-based compensation but was increased due to an increase in accounts receivable of
$963,000, mainly due to grants to be received from the OCS. Net cash used in investing activities
for the six months ended June 30, 2007 was $844,000 and consisted primarily of purchases of
property and equipment. Net cash provided by financing activities for the six months ended June
30, 2007 was $12.9 million, consisting of the proceeds from the exercise of certain warrants.
Future Funding Requirements
We expect to incur losses from operations for the foreseeable future. We expect to incur
increasing research and development expenses, including expenses related to the hiring of personnel
and additional clinical trials. We expect that general and administrative expenses will also
increase as we expand our finance and administrative staff, add infrastructure, and incur
additional costs related to being a public company in the United States, including the costs of
directors and officers insurance, investor relations programs and increased professional fees.
In addition, we are considering a new manufacturing facility for the manufacture of our product
candidates, which would increase our capital expenditures significantly.
We believe that our existing cash and cash equivalents and short-term investments will be
sufficient to enable us to fund our operating expenses and capital expenditure requirements for at
least for the next 24 months. We have based this estimate on assumptions that are subject to
change and may prove to be wrong, and we may be required to use our available capital resources
sooner than we currently expect. Because of the numerous risks and uncertainties associated with
the development and commercialization of our product candidates, we are unable to estimate the
amounts of increased capital outlays and operating expenditures associated with our current and
anticipated clinical trials.
Our future capital requirements will depend on many factors, including the progress and
results of our clinical trials, the duration and cost of discovery and preclinical development and
laboratory testing and clinical trials for our product candidates, the timing and outcome of
regulatory review of our product candidates, the costs involved in preparing, filing, prosecuting,
maintaining, defending and enforcing patent claims and other intellectual property rights, the
number and development requirements of other product candidates that we pursue and the costs of
commercialization activities, including product marketing, sales and distribution.
We will need to finance our future cash needs through public or private equity offerings, debt
financings or corporate collaboration and licensing arrangements. We currently do not have any
commitments for future external funding. We may need to raise additional funds more quickly if one
or more of our assumptions prove to be incorrect or if we choose to expand our product development
efforts more rapidly than we presently anticipate. We may also decide to raise additional funds
even before we need them if the conditions for raising capital are favorable. The sale of
additional equity or debt securities will likely result in dilution to our shareholders. The
incurrence of indebtedness would result in increased fixed obligations and could also result in
covenants that would restrict our operations. Additional equity or debt financing, grants or
corporate collaboration and licensing arrangements may not be available on acceptable terms, if at
all. If adequate funds are not available, we may be required to delay, reduce the scope of or
eliminate our research and development programs, reduce our planned commercialization efforts or
obtain funds through arrangements with collaborators or others that may require us to relinquish
rights to certain product candidates that we might otherwise seek to develop or commercialize
independently.
Effects of Inflation and Currency Fluctuations
Inflation generally affects us by increasing our cost of labor and clinical trial costs. We
do not believe that inflation has had a material effect on our results of operations during the six
months ended June 30, 2008 or the six months ended June 30, 2007.
14
Currency fluctuations could affect us by increased or decreased costs mainly for goods and
services acquired outside of Israel. We do not believe currency fluctuations have had a material
effect on our results of operations during the six months ended June 30, 2008 or the six months
ended June 30, 2007.
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements as of each of June 30, 2008 and June 30, 2007.
Recently Issued Accounting Pronouncements
In December 2007, the Financial Accounting Standards Board, or the FASB, issued Statement of
Financial Accounting Standards No. 141 (revised 2007), Business Combinations, or SFAS 141(R).
SFAS 141(R) changes the accounting for business combinations, including the measurement of acquirer
shares issued in consideration for a business combination, the recognition of contingent
consideration, the accounting for contingencies, the recognition of capitalized in-process research
and development, the accounting for acquisition-related restructuring cost accruals, the treatment
of acquisition related transaction costs and the recognition of changes in the acquirers income
tax valuation allowance and income tax uncertainties. SFAS 141(R) applies prospectively to
business combinations for which the acquisition date is on or after the beginning of the first
annual reporting period beginning on or after December 15, 2008. Early application is prohibited.
We will be required to adopt SFAS 141(R) on January 1, 2009.
In December 2007, the FASB issued Statement of Financial Accounting Standards No. 160,
Noncontrolling Interests in Consolidated Financial Statements, an Amendment of ARB No. 51, or
SFAS 160. SFAS 160 amends ARB No. 51 to establish accounting and reporting standards for the
noncontrolling interest in a subsidiary and for the deconsolidation of a subsidiary. Ownership
interests in subsidiaries held by parties other than the parent company of the subsidiary are
required to be presented in the consolidated statement of financial position within equity, but
separate from the parent companys equity. SFAS 160 requires that changes in a parent companys
ownership interest while the parent company retains its controlling financial interest in its
subsidiary should be accounted for in a manner similar to the accounting treatment of equity
transactions. When a subsidiary is deconsolidated, any retained noncontrolling equity investment
in the former subsidiary should be initially measured at fair value, with any gain or loss
recognized in earnings. SFAS 160 requires consolidated net income to be reported in amounts that
include the amounts attributable to both the parent company and the noncontrolling interest. It
also requires disclosure, on the face of the consolidated income statement, of the amounts of
consolidated net income attributable to both parent companies and the noncontrolling interests.
SFAS 160 is effective for fiscal years (including interim periods within those fiscal years)
beginning on or after December 15, 2008. Earlier adoption is prohibited. Companies are required
to apply SFAS 160 prospectively as of the beginning of the fiscal year in which it is initially
applied, except for the presentation and disclosure requirement which shall be applied
retrospectively for all periods presented. We are required to adopt SFAS 160 as of January 1,
2009. We are currently assessing the impact that SFAS 160 may have on our results of operations
and financial position.
In December 2007, the FASB ratified EITF Issue No. 07-01, Accounting for Collaborative
Arrangements, or EITF 07-01. EITF 07-01 defines collaborative arrangements and establishes
reporting requirements for transactions between participants in a collaborative arrangement and
between participants in the arrangement and third parties. EITF 07-01 also establishes the
appropriate income statement presentation and classification for joint operating activities and
payments between participants, as well as the sufficiency of the disclosures related to these
arrangements. EITF 07-01 is effective for fiscal years beginning after December 15, 2008 (January
1, 2009, for our company). Companies are required to apply EITF 07-01 using a modified version of
retrospective transition for those arrangements in place at the effective date. In addition,
companies are required to report the effects of the application of EITF 07-01 as a change in
accounting principle through retrospective application to all prior periods presented for all
arrangements existing as of the effective date, unless it is impracticable to apply the effects of
the change retrospectively. We are currently assessing the impact that EITF 07-01 may have on our
results of operations and financial position.
15
In March 2008, the FASB issued Statement of Financial Accounting Standards No. 161
Disclosures about Derivative Instruments and Hedging Activities, or SFAS 161. SFAS 161 is
intended to improve financial reporting regarding derivative instruments and hedging activities by
requiring enhanced disclosure to enable investors to better understand the effects of such
derivative instruments and hedging activities on a companys financial position, financial
performance and cash flows. It is effective for financial statements issued for fiscal years and
interim periods beginning after November 15, 2008, with early application encouraged (January 1,
2009, for our company). SFAS 161 also improves transparency regarding the location and amounts of
derivative instruments in a companys financial statements; how derivative instruments and related
hedged items are accounted for under SFAS No. 133 Accounting for Derivative Instruments and
Hedging Activities and how derivative instruments and related hedged items affect a companys
financial position, financial performance and cash flows. We are currently evaluating the effect
SFAS No. 161 will have on our financial statement presentations.
In May 2008, the FASB issued Statement of Financial Accounting Standards No. 162, The
Hierarchy of Generally Accepted Accounting Principles, or SFAS 162. SFAS 162 is intended to
improve financial reporting by identifying a consistent hierarchy for selecting accounting
principles to be used in preparing financial statements that are presented in conformity with U.S.
generally accepted accounting principles (GAAP). SFAS 162 will go into effect 60 days following
the approval of the Public Company Accounting Oversight Board Auditing amendments to AU Section 411
The Meaning of Present Fairly in Conformity with Generally Accepted Accounting Principles by the
Securities and Exchange Commission, or the Commission. We do not expect the adoption of SFAS 162
to have a material impact on our results of operations and financial position.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Currency Exchange Risk
The currency of the primary economic environment in which our operations are conducted is the
dollar. We are currently in the development stage with no significant source of revenues;
therefore we consider the currency of the primary economic environment to be the currency in which
we expend cash. Approximately 50% of our expenses and capital expenditures are incurred in
dollars, and a significant source of our financing has been provided in U.S. dollars. Since the
dollar is the functional currency, monetary items maintained in currencies other than the dollar
are remeasured using the rate of exchange in effect at the balance sheet dates and non-monetary
items are remeasured at historical exchange rates. Revenue and expense items are remeasured at the
average rate of exchange in effect during the period in which they occur. Foreign currency
translation gains or losses are recognized in the statement of operations.
Approximately 35% of our costs, including salaries, expenses and office expenses, are incurred
in New Israeli Shekels, the NIS. Inflation in Israel may have the effect of increasing the U.S.
dollar cost of our operations in Israel. If the U.S. dollar declines in value in relation to the
NIS, it will become more expensive for us to fund our operations in Israel. A revaluation of 1% of
the NIS will affect our income before tax by less than 1%. The exchange rate of the U.S. dollar to
the NIS, based on exchange rates published by the Bank of Israel, was as follows:
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Six months ended |
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Year ended |
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June 30, |
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December 31, |
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2008 |
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2007 |
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2007 |
Average rate for period |
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3.5218 |
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4.1499 |
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4.1081 |
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Rate at period end |
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3.3520 |
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4.2490 |
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3.8460 |
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To date, we have not engaged in hedging transactions. In the future, we may enter into
currency hedging transactions to decrease the risk of financial exposure from fluctuations in the
exchange rate of the U.S. dollar against the NIS. These measures, however, may not adequately
protect us from material adverse effects due to the impact of inflation in Israel.
16
Interest Rate Risk
Our exposure to market risk is confined to our cash and cash equivalents. We consider all
short term, highly liquid investments, which include short-term deposits with original maturities
of three months or less from the date of purchase, that are not restricted as to withdrawal or use
and are readily convertible to known amounts of cash, to be cash equivalents. The primary
objective of our investment activities is to preserve principal while maximizing the interest
income we receive from our investments, without increasing risk. We invest any cash balances
primarily in bank deposits and investment grade interest-bearing instruments. We are exposed to
market risks resulting from changes in interest rates. We do not use derivative financial
instruments to limit exposure to interest rate risk. Our interest gains may decline in the future
as a result of changes in the financial markets.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
We conducted an evaluation of the effectiveness of the design and operation of our disclosure
controls and procedures as of the end of the period covered by this Quarterly Report on Form 10-Q.
The controls evaluation was conducted under the supervision, and with the participation, of
management, including our Chief Executive Officer and Chief Financial Officer. Disclosure controls
and procedures are controls and procedures designed to reasonably assure that information required
to be disclosed in our reports filed under the Exchange Act, such as this Quarterly Report on Form
10-Q, is recorded, processed, summarized and reported within the time periods specified in the
Commissions rules and forms. Disclosure controls and procedures are also designed to reasonably
assure that such information is accumulated and communicated to our management, including the Chief
Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding
required disclosure.
Based on the controls evaluation, our Chief Executive Officer and Chief Financial Officer have
concluded that, as of the end of the period covered by this Quarterly Report on Form 10-Q, our
disclosure controls and procedures were effective to provide reasonable assurance that information
required to be disclosed in our Exchange Act reports is recorded, processed, summarized and
reported within the time periods specified by the Commission, and that material information
relating to our company and our consolidated subsidiary is made known to management, including the
Chief Executive Officer and Chief Financial Officer, particularly during the period when our
periodic reports are being prepared.
Inherent Limitations on Effectiveness of Controls
Our management, including our Chief Executive Officer and Chief Financial Officer, does not
expect that our disclosure controls and procedures or our internal control over financial reporting
will prevent or detect all error and all fraud. A control system, no matter how well designed and
operated, can provide only reasonable, not absolute, assurance that the control systems objectives
will be met. The design of a control system must reflect the fact that there are resource
constraints, and the benefits of controls must be considered relative to their costs. Further,
because of the inherent limitations in all control systems, no evaluation of controls can provide
absolute assurance that misstatements due to error or fraud will not occur or that all control
issues and instances of fraud, if any, within a company have been detected. These inherent
limitations include the realities that judgments in decision-making can be faulty and that
breakdowns can occur because of simple error or mistake. Controls can also be circumvented by the
individual acts of some persons, by collusion of two or more people or by management override of
the controls. The design of any system of controls is based in part on certain assumptions about
the likelihood of future events, and there can be no assurance that any design will succeed in
achieving its stated goals under all potential future conditions. Projections of any evaluation of
controls effectiveness to future periods are subject to risks. Over time, controls may become
inadequate because of changes in conditions or deterioration in the degree of compliance with
policies or procedures.
Changes in internal controls
There were no change in our internal controls over financial reporting (as defined in Rules
13a-15f and 15d-15f under the Exchange Act) that occurred during the period ended June 30, 2008
that has materially affected, or that is reasonably likely to materially affect, our internal
control over financial reporting.
17
PART II OTHER INFORMATION
Item 1. Legal Proceedings
We are not involved in any material legal proceedings.
Item 1A. Risk Factors
We describe our business risk factors below. This description includes any material changes
to and supersedes the description of the risk factors associated with our business previously
disclosed in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended
December 31, 2007.
Trading of our common stock is limited.
Our common stock began trading on the American Stock Exchange in March 2007. To date, the
liquidity of our common stock is limited, not only in terms of the number of shares that can be
bought and sold at a given price, but also through delays in the timing of transactions and
changes in security analyst and media coverage, if at all. These factors may result in lower
prices for our common stock than might otherwise be obtained and could also result in a larger
spread between the bid and ask prices for our common stock.
In connection with the merger, substantially all of the former shareholders of Protalix
Ltd. entered into lock-up agreements with respect to their shares of our common stock to satisfy
Israeli tax laws and contractual obligations. The lock-up agreements prohibited such former
shareholders of Protalix Ltd. from, directly or indirectly, selling or otherwise transferring
the shares of our common stock issued to them in connection with the merger during a period
commencing upon the closing of the merger and ending on January 1, 2009. However, during such
period, each such former Protalix Ltd. shareholder was permitted, under the terms of the lock-up
agreements and the tax ruling described below, to sell an aggregate of 10% of each such
shareholders original number of locked-up shares. All permitted sales of locked-up shares that
may be made during such time period are cumulative. On June 11, 2008, after completing
discussions with the Israeli tax authorities regarding the tax ruling, we approved the early
termination of the lock-up agreements for holders of 5% or less of our outstanding shares as of
the closing of the merger. The early termination of the lock-up agreements allows an additional
22,929,381 shares of our common stock to become eligible for sale on the public market.
However, up to 35,875,319 shares of our common stock and options and warrants to purchase
3,046,052 shares of our common stock, or approximately 51.3% of our outstanding shares of common
stock, remain subject to the lock-up agreements until January 1, 2009.
Under applicable Israeli tax law incorporated by reference into the tax ruling obtained by
Protalix Ltd. from the Israeli tax authorities in connection with the merger, until January 1,
2009, we must maintain our holding of at least 51% of Protalix Ltd. and our shareholders at the
time of the consummation of the merger must maintain, in the aggregate, holdings of at least 51%
of our outstanding share capital. This restriction limits, to an extent, the volume of our
shares available for public trading.
In the absence of an active public trading market, an investor may be unable to liquidate
its investment in our common stock. Trading of a relatively small volume of our common stock
may have a greater impact on the trading price of our stock than would be the case if our public
float were larger. Further, the limited liquidity could be an indication that the trading price
is not reflective of the actual fair market value of our common stock.
Future sales of our common stock could reduce our stock price.
Sales by shareholders of substantial amounts of our shares, the issuance of new shares by
us or the perception that these sales may occur in the future, could affect materially and
adversely the market price of our common stock. As described herein, substantially all of the
former shareholders of Protalix Ltd. (holding, in the aggregate, 65,094,232 shares of our common
stock and options and warrants to purchase 3,628,826 shares of our common stock) entered into
lock-up agreements with respect to their securities of our company to satisfy Israeli tax laws
and contractual obligations. The lock-up agreements prohibit such former shareholders of
Protalix Ltd. from, directly or indirectly, selling or otherwise transferring the shares of our
common stock issued to them in connection with the merger during a period commencing upon the
closing of the merger and ending on January 1,
18
2009. However, during such period, each such
former Protalix Ltd. shareholder may, under the terms of the lock-up agreements and a tax ruling
received by Protalix Ltd. from the Israeli tax authorities in connection with the merger, sell
an aggregate of 10% of each such shareholders original number of locked-up shares. On June 11,
2008, after completing discussions with the Israeli tax authorities regarding the tax ruling, we
approved the early termination of the lock-up agreements for holders of 5% or less of our
outstanding shares as of the closing of the merger. The early termination of the lock-up
agreements allows an additional 22,929,381 shares of our common stock to become eligible for
sale on the public market.
In addition, on January 1, 2009, the remaining lock-up agreements entered into in connection
with the merger will expire which will allow an additional 35,875,319 shares of our common stock
and options and warrants to purchase 3,046,052 shares of our common stock, or approximately 51.3%
of our outstanding shares of common stock, to be available for sale on the public market, subject
in most cases to the limitations of either Rule 144 or Rule 701 under the Securities Act.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Unregistered Sales of Equity Securities
There have been no unregistered sales of equity securities during the quarter ended June 30,
2008, other than the issuance of 154,796 shares of common stock, in the aggregate, in connection
with the exercise by certain of our officers and employees of outstanding stock options to purchase
189,460 shares of common stock granted under our 2006 Stock Incentive Plan. We received cash
proceeds equal to $3,000 in connection with such exercises as 167,440 of such options were
exercised on a net-exercise basis. The shares were issued pursuant to exemptions from
registration under Section 4(2) of the Securities Act of 1933.
Use of Proceeds
The effective date of our first registration statement, filed on Form S-3 under the Securities
Act of 1933, which was accompanied by a registration statement on Form S-3 filed pursuant to Rule
462(b) under the Securities Act (Nos. 333-144801 and 333-146919), relating to a public offering of
our common stock, was September 26, 2007 and the offering date was October 25, 2007. The sole
book-running manager of the offering was UBS Investment Bank and CIBC World Markets (now
Oppenheimer) served as the co-manager. In the offering we sold 10,000,000 shares of common stock
at a price per share of $5.00. Our aggregate net proceeds (after underwriting discounts and
expenses) amounted to approximately $46 million. The offering closed on October 30, 2007.
The amount of the underwriting discount paid by us was $3.5 million and the expenses of the
offering, not including the underwriting discount, were approximately $810,000.
To date, the net proceeds of the offering were invested in accordance with our investment
policy in short-term marketable securities. We intend to use the proceeds in the manner set forth
in our prospectus of October 25, 2007.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Submission of Matters to a Vote of Security Holders
None.
Item 5. Other Information
On August 7, 2008, our Board of Directors adopted Amended and Restated Bylaws. The Amended
and Restated Bylaws differ from our previous Bylaws in several respects. Our Board of Directors
adopted the Amended and Restated Bylaws to modernize the by-laws and provide clarity and
consistency with the Florida Business Corporation Act. The primary and substantive changes are as
follows:
19
The Amended and Restated Bylaws include two advance notice provisions, which apply when a
shareholder wishes to present either (i) a proposal relating to the nomination of directors or (ii)
a proposal relating to matters other than nominations of directors, otherwise than pursuant to Rule
14a-8 of the proxy rules of the Commission. The provisions require that a shareholder desiring to
introduce a proposal, or nominate a director, at a meeting of shareholders, deliver notice to our
Secretary not less than 45 days nor more than 75 days prior to the date on which we first mailed
its proxy materials for the previous years annual meeting of shareholders (or, in the absence of
proxy materials, mailed its notice of meeting) in order to include a proposal at the annual
meeting. The notice must set forth certain information, including a description of the matters
proposed to be discussed.
In each of the two advance notice provisions, our Board of Directors added a requirement that
any shareholder submitting a shareholder proposal must make certain disclosures regarding any
derivative or short positions, profit interests, options, warrants, stock appreciation or similar
rights, hedging transactions, and borrowed or loaned shares of our company.
Section 6.1 of the Amended and Restated Bylaws was amended to allow for shares of our stock to
be represented in certificated and uncertificated form, which is consistent with the trading rules
of the American Stock Exchange.
In the provision regarding amendments to the Amended and Restated Bylaws, our Board of
Directors removed the ability of shareholders to specify in any bylaw made by them that such bylaw
cannot be altered, amended, or repealed by our Board of Directors.
In addition to these substantive changes, our Board of Directors made several amendments to
modernize the bylaws, which include provisions permitting remote communications, expanding
indemnification rights of officers and directors, and altering the notice provisions in accordance
with the Florida Business Corporation Act to give notice of a shareholder meeting not less than 20
nor more than 60 days in advance of the meeting where the matter to be acted on is a merger or
consolidation or a sale, lease, or exchange of all or substantially all of our assets.
Item 6. Exhibits
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Exhibit |
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Number |
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Exhibit Description |
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Method of Filing |
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3.1
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Amended and Restated Articles
of Incorporation of the
Company
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Incorporated by
reference to the
Companys Registration
Statement on Form S-4
filed on March 26,
1998, SEC File No.
333-48677 |
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3.2
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Article of Amendment to
Articles of Incorporation
dated June 9, 2006
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Incorporated by
reference to the
Companys Registration
Statement on Form 8-A
filed on March 9,
2007, SEC File No.
001-33357 |
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3.3
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Article of Amendment to
Articles of Incorporation
dated December 13, 2006
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Incorporated by
reference to the
Companys Registration
Statement on Form 8-A
filed on March 9,
2007, SEC File No.
001-33357 |
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3.4
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Article of Amendment to
Articles of Incorporation
dated December 26, 2006
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Incorporated by
reference to the
Companys Registration
Statement on Form 8-A
filed on March 9,
2007, SEC File No.
001-33357 |
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3.5
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Article of Amendment to
Articles of Incorporation
dated February 26, 2007
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Incorporated by
reference to the
Companys Registration
Statement on Form 8-A
filed on March 9,
2007, SEC File No.
001-33357 |
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3.6
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Amended and Restated By-Laws
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Filed herewith |
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Exhibit |
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Number |
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Exhibit Description |
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Method of Filing |
31.1
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Certification of Chief
Executive Officer pursuant to
Rule 13a-14(a) as adopted
pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
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Filed herewith |
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31.2
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Certification of Chief
Financial Officer pursuant to
Rule
13a-14(a) as adopted
pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
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Filed herewith |
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32.1
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18 U.S.C. Section 1350, as
adopted pursuant to Section
906 of the Sarbanes-Oxley Act
of 2002, Certification of
Chief Executive Officer
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Filed herewith |
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32.2
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18 U.S.C. Section 1350, as
adopted pursuant to Section
906 of the Sarbanes-Oxley Act
of 2002, Certification of
Chief Financial Officer
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Filed herewith |
21
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the
registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly
authorized.
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PROTALIX BIOTHERAPEUTICS, INC.
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(Registrant)
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Date: August 8, 2008 |
By: |
/s/ David Aviezer
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David Aviezer, Ph.D. |
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President and Chief Executive Officer
(Principal Executive Officer) |
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Date: August 8, 2008 |
By: |
/s/ Yossi Maimon
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Yossi Maimon |
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Chief Financial Officer, Treasurer and Secretary
(Principal Financial and Accounting Officer) |
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22
EX-3.6
Exhibit 3.6
AMENDED AND RESTATED BYLAWS
OF
PROTALIX BIOTHERAPEUTICS, INC.
ARTICLE I
OFFICES
Section 1.1 Registered Office.
The registered office of the corporation in the State of Florida shall be 1201 Hays Street,
Tallahassee, Florida 32301.
Section 1.2 Other Offices.
The corporation shall also have and maintain an office or principal place of business at 2
Snunit Street, Science Park, PO Box 455, Carmiel Israel 20100, and may also have offices at such
other places, both within and without the State of Florida, as the Board of Directors may from time
to time determine or the business of the corporation may require.
Section 1.3 Registered Agent.
The Board of Directors shall designate a registered agent for service of process on the
corporation for the State of Florida and for each state in which the corporation qualifies to do
business.
ARTICLE II
SHAREHOLDERS MEETINGS
Section 2.1 Place of Meetings.
(a) Meetings of shareholders may be held at such place, either within or without this State,
as may be designated by or in the manner provided in these Bylaws or, if not so designated, as
determined by the Board of Directors. The Board of Directors may, in its sole discretion,
determine that the meeting shall not be held at any place, but may instead be held solely by means
of remote communication as authorized by paragraph (b) of this Section 2.1.
(b) If authorized by the Board of Directors in its sole discretion, and subject to such
guidelines and procedures as the Board of Directors may adopt, shareholders and proxyholders not
physically present at a meeting of shareholders may, by means of remote communication:
(1) Participate in a meeting of shareholders; and
(2) Be deemed present in person and vote at a meeting of shareholders whether such meeting is
to be held at a designated place or solely by means of remote communication, provided that (A) the
corporation shall implement reasonable measures to verify that each person deemed present and
permitted to vote at the meeting by means of remote communication is a shareholder or proxyholder,
(B) the corporation shall implement reasonable measures to provide such shareholders and
proxyholders a reasonable opportunity to participate in the meeting and to vote on matters
submitted to the shareholders, including an opportunity to read or hear the proceedings of the
meeting substantially concurrently with such proceedings, and (C) if any shareholder or proxyholder
votes or takes other action at the meeting by means of remote communication, a record of such vote
or other action shall be maintained by the corporation.
For purposes of this Section 2.1, remote communication shall include (1) telephone or other
voice communications and (2) electronic mail or other form of written or visual electronic
communications satisfying the requirements of Section 2.11(b).
Section 2.2 Annual Meetings.
The annual meetings of the shareholders of the corporation, for the purpose of election of
directors and for such other business as may lawfully come before it, shall be held on such date
and at such time as may be designated from time to time by the Board of Directors.
Section 2.3 Special Meetings.
Special Meetings of the shareholders of the corporation may be called, for any purpose or
purposes, by the Chairman of the Board or the President or the Board of Directors at any time.
Upon written request of any shareholder or shareholders holding in the aggregate not less than 10%
of all of the votes entitled to be cast on any issue proposed to be considered at the Special
Meeting signed, dated and delivered in person or sent by registered mail to the Chairman of the
Board, President or Secretary of the corporation, the Secretary shall call a special meeting of
shareholders to be held at the principal office of the corporation or at such place and at such
time as the Secretary may fix, such meeting to be held not less than 10 nor more than 60 days after
the receipt of such request, and if the Secretary shall neglect or refuse to call such meeting
within seven days after the receipt of such request, the shareholder making such request may do so.
Section 2.4 Notice of Meetings.
(a) Except as otherwise provided by law or the corporations Articles of Incorporation, as
amended, written notice of each meeting of shareholders, specifying the place, if any, date and
hour and purpose or purposes of the meeting, and the means of remote communication, if any, by
which shareholders and proxyholders may be deemed to be present in person and vote at such meeting
shall be given not less than 10 nor more than 60 days before the date of the meeting to each
shareholder entitled to vote thereat, directed to his, her or its address as it appears upon the
books of the corporation; except that where the matter to be acted on is a merger or consolidation
of the corporation or a sale, lease or exchange of all or substantially all of its assets, such
notice shall be given not less than 20 nor more than 60 days prior to such meeting.
2
(b) If at any meeting action is proposed to be taken which, if taken, would entitle
shareholders fulfilling the requirements of Section 607.1302 of the Florida Business Corporation
Act to an appraisal of the fair value of their shares, the notice of such meeting shall contain a
statement of that purpose and to that effect and shall be accompanied by a copy of Sections
607.1301 through 607.1333 of the Florida Business Corporation Act.
(c) When a meeting is adjourned to another time or place, notice need not be given of the
adjourned meeting if the time, place, if any, thereof, and the means of remote communication, if
any, by which shareholders and proxyholders may be deemed to be present in person and vote at such
adjourned meeting, are announced at the meeting at which the adjournment is taken unless the
adjournment is for more than 30 days, or unless after the adjournment a new record date is fixed
for the adjourned meeting, in which event a notice of the adjourned meeting shall be given to each
shareholder of record entitled to vote at the meeting.
(d) Notice of the time, place and purpose of any meeting of shareholders may be waived in
writing, either before or after such meeting, and, to the extent permitted by law, will be waived
by any shareholder by his attendance thereat, in person or by proxy. Any shareholder so waiving
notice of such meeting shall be bound by the proceedings of any such meeting in all respects as if
due notice thereof had been given.
(e) Without limiting the manner by which notice otherwise may be given effectively to
shareholders, any notice to shareholders given by the corporation under any provision of the
Florida Business Corporation Act, the corporations Articles of Incorporation, as amended, or these
Amended and Restated Bylaws shall be effective if given by a form of electronic transmission
consented to by the shareholder to whom the notice is given. Any such consent shall be revocable
by the shareholder by written notice to the corporation. Any such consent shall be deemed revoked
if (i) the corporation is unable to deliver by electronic transmission two consecutive notices
given by the corporation in accordance with such consent and (ii) such inability becomes known to
the secretary or an assistant secretary of the corporation or to the transfer agent or other person
responsible for the giving of notice; provided, however, the inadvertent failure to
treat such inability as a revocation shall not invalidate any meeting or other action. Notice
given pursuant to this subparagraph (e) shall be deemed given: (1) if by facsimile
telecommunication, when directed to a number at which the shareholder has consented to receive
notice; (2) if by electronic mail, when directed to an electronic mail address at which the
shareholder has consented to receive notice; (3) if by a posting on an electronic network together
with separate notice to the shareholder of such specific posting, upon the later of (A) such
posting and (B) the giving of such separate notice; and (4) if by any other form of electronic
transmission, when directed to the shareholder. An affidavit of the Secretary or an assistant
secretary or of the transfer agent or other agent of the corporation that the notice has been given
by a form of electronic transmission shall, in the absence of fraud, be prima facie evidence of the
facts stated therein. For purposes of these Amended and Restated Bylaws, electronic transmission
means any form of communication, not directly involving the physical transmission of paper, that
creates a record that may be retained, retrieved and reviewed by a recipient thereof, and that may
be directly reproduced in paper form by such a recipient through an automated process.
3
Section 2.5 Quorum and Voting.
(a) At all meetings of shareholders except where otherwise provided by law, the corporations
Articles of Incorporation or these Amended and Restated Bylaws, the presence, in person or by proxy
duly authorized, of the holders of a majority of the outstanding shares of stock entitled to vote
shall constitute a quorum for the transaction of business. Shares, the voting of which at said
meeting have been enjoined, or which for any reason cannot be lawfully voted at such meeting, shall
not be counted to determine a quorum at said meeting. In the absence of a quorum, any meeting of
shareholders may be adjourned, from time to time, by vote of the holders of a majority of the
shares represented thereat, but no other business shall be transacted at such meeting. At such
adjourned meeting at which a quorum is present or represented, any business may be transacted which
might have been transacted at the original meeting. The shareholders present at a duly called or
convened meeting at which a quorum is present may continue to transact business until adjournment,
notwithstanding the withdrawal of enough shareholders to leave less than a quorum.
(b) Except as otherwise provided by law, the corporations Articles of Incorporation or these
Amended and Restated Bylaws, all action taken by the holders of a majority of the voting power
represented at any meeting at which a quorum is present shall be valid and binding upon the
corporation.
(c) Where a separate vote by a class or classes is required, a majority of the outstanding
shares of such class or classes present in person or represented by proxy shall constitute a quorum
entitled to take action with respect to that vote on that matter, and the affirmative vote of the
majority of shares of such class or classes present in person or represented by proxy at the
meeting shall be the act of such class.
Section 2.6 Voting Rights.
(a) Except as otherwise provided by law, only persons in whose names shares entitled to vote
stand on the stock records of the corporation on the record date for determining the shareholders
entitled to vote at said meeting shall be entitled to vote at such meeting. Shares standing in the
names of two or more persons shall be voted or represented in accordance with the determination of
the majority of such persons, or, if only one of such persons is present in person or represented
by proxy, such person shall have the right to vote such shares and such shares shall be deemed to
be represented for the purpose of determining a quorum.
(b) Every person entitled to vote or to execute consents shall have the right to do so either
in person or by an agent or agents authorized by a written proxy executed by such person or his
duly authorized agent, which proxy shall be filed with the Secretary of the corporation at or
before the meeting at which it is to be used. Said proxy so appointed need not be a shareholder.
No proxy shall be voted on after eleven (11) months from its date unless the proxy provides for a
longer period. Unless and until voted, every proxy shall be revocable at the pleasure of the
person who executed it or of his legal representatives or assigns, except in those cases where an
irrevocable proxy permitted by statute has been given.
4
(c) Without limiting the manner in which a shareholder may authorize another person or persons
to act for him as proxy pursuant to subsection (b) of this section, the following shall constitute
a valid means by which a shareholder may grant such authority:
(1) A shareholder may execute a writing authorizing another person or persons to act for him
as proxy. Execution may be accomplished by the shareholder or his authorized officer, director,
employee or agent signing such writing or causing his or her signature to be affixed to such
writing by any reasonable means including, but not limited to, by facsimile signature.
(2) A shareholder may authorize another person or persons to act for him as proxy by
transmitting or authorizing the transmission of a telephone, telegram, cablegram or other means of
electronic transmission to the person who will be the holder of the proxy or to a proxy
solicitation firm, proxy support service organization or like agent duly authorized by the person
who will be the holder of the proxy to receive such transmission, provided that any such telephone,
telegram, cablegram or other means of electronic transmission must either set forth or be submitted
with information from which it can be determined that the telephone, telegram, cablegram or other
electronic transmission was authorized by the shareholder. Such authorization can be established
by the signature of the shareholder on the proxy, either in writing or by a signature stamp or
facsimile signature, or by a number or symbol from which the identity of the shareholder can be
determined, or by any other procedure deemed appropriate by the inspectors or other persons making
the determination as to due authorization.
(d) Any copy, facsimile telecommunication or other reliable reproduction of the writing or
transmission created pursuant to subsection (c) of this section may be substituted or used in lieu
of the original writing or transmission for any and all purposes for which the original writing or
transmission could be used, provided that such copy, facsimile telecommunication or other
reproduction shall be a complete reproduction of the entire original writing or transmission.
Section 2.7 Voting Procedures and Inspectors of Elections.
(a) The corporation shall, in advance of any meeting of shareholders, appoint one or more
inspectors to act at the meeting and make a written report thereof. The corporation may designate
one or more persons as alternate inspectors to replace any inspector who fails to act. If no
inspector or alternate is able to act at a meeting of shareholders, the person presiding at the
meeting shall appoint one or more inspectors to act at the meeting. Each inspector, before
entering upon the discharge of his duties, shall take and sign an oath faithfully to execute the
duties of inspector with strict impartiality and according to the best of his, her or its ability.
(b) The inspectors shall (i) ascertain the number of shares outstanding and the voting power
of each, (ii) determine the shares represented at a meeting and the validity of proxies and
ballots, (iii) count all votes and ballots, (iv) determine and retain for a reasonable period a
record of the disposition of any challenges made to any determination by the inspectors and (v)
certify their determination of the number of shares represented at the meeting and their count of
all votes and ballots. The inspectors may appoint or retain other persons or entities to assist
the inspectors in the performance of the duties of the inspectors.
5
(c) The date and time of the opening and the closing of the polls for each matter upon which
the shareholders will vote at a meeting shall be announced at the meeting. No ballot, proxies or
votes, nor any revocations thereof or changes thereto, shall be accepted by the inspectors after
the closing of the polls unless a court of competent jurisdiction, upon application by shareholders
entitled to vote at said meeting shall determine otherwise.
(d) In determining the validity and counting of proxies and ballots, the inspectors shall be
limited to an examination of the proxies, any envelopes submitted with those proxies, any
information provided in accordance with the Florida Business Corporation Act, ballots and the
regular books and records of the corporation, except that the inspectors may consider other
reliable information for the limited purpose of reconciling proxies and ballots submitted by or on
behalf of banks, brokers, their nominees or similar persons which represent more votes than the
holder of a proxy is authorized by the record owner to cast or more votes than the shareholder
holds of record. If the inspectors consider other reliable information for the limited purpose
permitted herein, the inspectors at the time they make their certification pursuant to subsection
(b)(v) of this section shall specify the precise information considered by them including the
person or persons from whom they obtained the information, when the information was obtained, the
means by which the information was obtained and the basis for the inspectors belief that such
information is accurate and reliable.
Section 2.8 List of Shareholders.
The officer who has charge of the stock ledger of the corporation shall prepare and make, or
shall cause to be prepared at least 10 days before every meeting of shareholders, a complete list
of the shareholders entitled to vote at said meeting showing the address of and the number of
shares registered in the name of each shareholder. The corporation need not include electronic
mail addresses or other electronic contact information on such list. Such list shall be open to
the examination of any shareholder for any purpose germane to the meeting for a period of at least
10 days prior to the meeting: (i) on a reasonably accessible electronic network, provided that the
information required to gain access to such list is provided with the notice of the meeting, or
(ii) during ordinary business hours at the principal place of business of the corporation. In the
event that the corporation determines to make the list available on an electronic network, the
corporation may take reasonable steps to ensure that such information is available only to
shareholders of the corporation. If the meeting is to be held at a place other than the principal
office of the corporation, the list shall be produced and kept at the time and place of the meeting
during the whole time thereof, and may be inspected by any shareholder who is present. If the
meeting is to be held solely by means of remote communication, then the list shall also be open to
the examination of any shareholder during the whole time of the meeting on a reasonably accessible
electronic network, and the information required to access such list shall be provided with the
notice of the meeting.
Section 2.9 Shareholder Proposals at Annual Meetings.
At an annual meeting of the shareholders, only such business shall be conducted as shall have
been properly brought before the meeting. To be properly brought before an annual meeting,
business must be specified in the notice of meeting (or any supplement thereto) given by or at the
direction of the Board of Directors, otherwise properly brought before the meeting
6
by or at the direction of the Board of Directors, or otherwise properly brought before the
meeting by a shareholder. In addition to any other applicable requirements for business to be
properly brought before an annual meeting by a shareholder, whether or not the shareholder is
seeking to have a proposal included in the corporations proxy statement or information statement
under any applicable rule of the Securities and Exchange Commission (the SEC), including, but not
limited to, Regulation 14A or Regulation 14C under the Securities and Exchange Act of 1934, as
amended (the Exchange Act), the shareholder must have given timely notice thereof in writing to
the Secretary of the corporation. To be timely, a shareholders notice must be delivered to or
mailed and received at the principal executive offices of the corporation not less than 45 days nor
more than 75 days prior to the date on which the corporation first mailed its proxy materials (or,
in the absence of proxy materials, its notice of the meeting) for the previous years annual
meeting of shareholders (or the date on which the corporation mails such materials for the current
year if during the prior year the corporation did not hold an annual meeting or if the date of the
annual meeting was changed more than 30 days from the prior year). A shareholders notice to the
Secretary shall set forth as to each matter the shareholder proposes to bring before the annual
meeting (i) a brief description of the business desired to be brought before the annual meeting and
the reasons for conducting such business at the annual meeting, (ii) the name and record address of
the shareholder proposing such business, (iii) the class and number of shares of the corporation
which are beneficially owned by the shareholder, (iv) any material interest of the shareholder in
such business, (v) as to the shareholder giving the notice and any Shareholder Associated Person
(as defined below), whether and the extent to which any hedging or other transaction or series of
transactions has been entered into by or on behalf of, or any other agreement, arrangement or
understanding (including, but not limited to, any short position or any borrowing or lending of
shares of stock) has been made, the effect or intent of which is to mitigate loss or increase
profit to or manage the risk or benefit of stock price changes for, or to increase or decrease the
voting power of, such shareholder or any such Shareholder Associated Person with respect to any
share of stock of the corporation (each, a Relevant Hedge Transaction), and (vi) as to the
shareholder giving the notice and any Shareholder Associated Person, to the extent not set forth
pursuant to the immediately preceding clause, (a) whether and the extent to which such shareholder
or Shareholder Associated Person has direct or indirect beneficial ownership of any option,
warrant, convertible security, stock appreciation right, or similar right with an exercise or
conversion privilege or a settlement payment or mechanism at a price related to any class or series
of shares of the corporation, whether or not such instrument or right shall be subject to
settlement in the underlying class or series of capital stock of the corporation or otherwise, or
any other direct or indirect opportunity to profit or share in any profit derived from any increase
or decrease in the value of shares of the corporation (a Derivative Instrument), (b) any rights
to dividends on the shares of the corporation owned beneficially by such shareholder that are
separated or separable from the underlying shares of the corporation, (c) any proportionate
interest in shares of the corporation or Derivative Instruments held, directly or indirectly, by a
general or limited partnership in which such shareholder is a general partner or, directly or
indirectly, beneficially owns an interest in a general partner and (d) any performance-related fees
(other than an asset-based fee) that such shareholder is entitled to based on any increase or
decrease in the value of shares of the corporation or Derivative Instruments, if any, as of the
date of such notice, including without limitation any such interests held by members of such
shareholders immediate family sharing the same household (which information shall be supplemented
by such shareholder and beneficial owner, if any, not later
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than 10 days after the record date for the meeting to disclose such ownership as of the record
date).
For purposes of this Section 2.9 and Section 2.10, Shareholder Associated Person of any
shareholder shall mean (i) any person controlling or controlled by, directly or indirectly, or
acting in concert with, such shareholder, (ii) any beneficial owner of shares of stock of the
corporation owned of record or beneficially by such shareholder and (iii) any person controlling,
controlled by or under common control with such Shareholder Associated Person.
Notwithstanding anything in these Amended and Restated Bylaws to the contrary, no business
shall be conducted at the annual meeting except in accordance with the procedures set forth in
Section 2.1 and this Section 2.9; provided, however, that nothing in this Section
2.9 shall be deemed to preclude discussion by any shareholder of any business properly brought
before the annual meeting in accordance with said procedure.
The Chairman of an annual meeting shall, if the facts warrant, determine and declare to the
meeting that business was not properly brought before the meeting in accordance with the provisions
of Section 2.1 and this Section 2.9, and if he should so determine he shall so declare to the
meeting, and any such business not properly brought before the meeting shall not be transacted.
Nothing in this Section 2.9 shall affect the right of a shareholder to request inclusion of a
proposal in the corporations proxy statement or information statement to the extent that such
right is provided by an applicable rule of the SEC.
Section 2.10 Nominations of Persons for Election to the Board of Directors.
In addition to any other applicable requirements, only persons who are nominated in accordance
with the following procedures shall be eligible for election as directors. Nominations of persons
for election to the Board of Directors of the corporation may be made at a meeting of shareholders
by or at the direction of the Board of Directors, by any nominating committee or person appointed
by the Board of Directors or by any shareholder of the corporation entitled to vote for the
election of directors at the meeting who complies with the notice procedures set forth in this
Section 2.10. Such nominations, other than those made by or at the direction of the Board of
Directors, shall be made pursuant to timely notice in writing to the Secretary of the corporation,
which shall be the exclusive means for a shareholder to make nominations whether or not the
shareholder is seeking to have a proposal included in the corporations proxy statement or
information statement under an applicable rule of the SEC, including, but not limited to,
Regulation 14A or Regulation 14C under the Exchange Act. To be timely, a shareholders notice must
be delivered to or mailed and received at the principal executive offices of the corporation, not
less than 45 days nor more than 75 days prior to the date on which the corporation first mailed its
proxy materials (or, in the absence of proxy materials, its notice of the meeting) for the previous
years annual meeting of shareholders (or the date on which the corporation mails such materials
for the current year if during the prior year the corporation did not hold an annual meeting or if
the date of the annual meeting was changed more than 30 days from the prior year). Such
shareholders notice shall set forth (a) as to each person whom the shareholder proposes to
nominate for election or re-election as a director, (i) the name, age,
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business address and residence address of the person, (ii) the principal occupation or
employment of the person, (iii) the class and number of shares of the corporation which are
beneficially owned by the person, and (iv) any other information relating to the person that is
required to be disclosed in solicitations for proxies for election of directors pursuant to
Regulation 14A under the Exchange Act; (b) as to the shareholder giving the notice, (i) the name
and record address of the shareholder, and (ii) the class and number of shares of the corporation
which are beneficially owned by the shareholder; (c) as to the shareholder giving the notice and
any Shareholder Associated Person (as defined in Section 2.9), to the extent not set forth pursuant
to the immediately preceding clause, whether and the extent to which any Relevant Hedge Transaction
(as defined in Section 2.9) has been entered into, and (d) as to the shareholder giving the notice
and any Shareholder Associated Person, (1) whether and the extent to which any Derivative
Instrument (as defined in Section 2.9) is directly or indirectly beneficially owned, (2) any rights
to dividends on the shares of the corporation owned beneficially by such shareholder that are
separated or separable from the underlying shares of the corporation, (3) any proportionate
interest in shares of the corporation or Derivative Instruments held, directly or indirectly, by a
general or limited partnership in which such shareholder is a general partner or, directly or
indirectly, beneficially owns an interest in a general partner and (4) any performance-related fees
(other than an asset-based fee) that such shareholder is entitled to based on any increase or
decrease in the value of shares of the corporation or Derivative Instruments, if any, as of the
date of such notice, including without limitation any such interests held by members of such
shareholders immediate family sharing the same household (which information shall be supplemented
by such shareholder and beneficial owner, if any, not later than 10 days after the record date for
the meeting to disclose such ownership as of the record date). The corporation may require any
proposed nominee to furnish such other information as may reasonably be required by the corporation
to determine the eligibility of such proposed nominee to serve as a director of the corporation.
No person shall be eligible for election as a director of the corporation unless nominated in
accordance with the procedures set forth herein. These provisions shall not apply to nomination of
any persons entitled to be separately elected by holders of preferred stock.
The Chairman of the meeting shall, if the facts warrant, determine and declare to the meeting
that a nomination was not made in accordance with the foregoing procedure, and if he should so
determine, he shall so declare to the meeting and the defective nomination shall be disregarded.
Section 2.11 Fixing Record Dates.
(a) In order that the corporation may determine the shareholders entitled to notice of or to
vote at any meeting of shareholders or any adjournment thereof, the Board of Directors may fix a
record date, which record date shall not precede the date upon which the resolution fixing the
record date is adopted by the Board of Directors, and which record date shall not be more than 60
nor less than 10 days before the date of such meeting. If no record date is fixed by the Board of
Directors, the record date for determining shareholders entitled to notice of or to vote at a
meeting of shareholders shall be at the close of business on the day next preceding the day on
which notice is given, or, if notice is waived, at the close of business on the day next preceding
the date on which the meeting is held. A determination of shareholders of record entitled notice
of or to vote at a meeting of shareholders shall apply to any adjournment of the meeting;
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provided, however, that the Board of Directors may fix a new record date for
the adjourned meeting.
(b) In order that the corporation may determine the shareholders entitled to receive payment
of any dividend or other distribution or allotment of any rights or the shareholders entitled to
exercise any rights in respect of any change, conversion or exchange of stock, or for the purpose
of any other lawful action, the Board of Directors may fix a record date, which record date shall
not precede the date upon which the resolution fixing the record date is adopted, and which record
date shall be not more than 60 days prior to such action. If no record date is fixed, the record
date for determining shareholders for any such purpose shall be at the close of business on the day
on which the Board of Directors adopts the resolution relating thereto.
ARTICLE III
DIRECTORS
Section 3.1 Number and Term of Office.
The number of directors which shall constitute the whole of the Board of Directors shall be
fixed from time to time by resolution of the Board of Directors. With the exception of the first
Board of Directors, which was elected by the incorporators, and except as provided in Section 3.3
of this Article III, the directors shall be elected by a plurality vote of the shares represented
in person or by proxy at the shareholders annual meeting in each year and entitled to vote on the
election of directors. Elected directors shall hold office until the next annual meeting and until
their successors shall be duly elected and qualified. Directors need not be shareholders. If, for
any cause, the Board of Directors shall not have been elected at an annual meeting, they may be
elected as soon thereafter as convenient at a special meeting of the shareholders called for that
purpose in the manner provided in these Amended and Restated Bylaws.
Section 3.2 Powers.
The powers of the corporation shall be exercised, its business conducted and its property
controlled by or under the direction of the Board of Directors.
Section 3.3 Vacancies.
Vacancies and newly created directorships resulting from any increase in the authorized number
of directors may be filled by a majority of the directors then in office, although less than a
quorum, or by a sole remaining director, and each director so elected shall hold office for the
unexpired portion of the term of the director whose place shall be vacant and until his successor
shall have been duly elected and qualified. A vacancy in the Board of Directors shall be deemed to
exist under this section in the case of the death, removal or resignation of any director, or if
the shareholders fail at any meeting of shareholders at which directors are to be elected
(including any meeting referred to in Section 3.4 below) to elect the number of directors then
constituting the whole Board.
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Section 3.4 Resignations and Removals.
(a) Any director may resign at any time by delivering his resignation to the Secretary in
writing or by electronic transmission, such resignation to specify whether it will be effective at
a particular time, upon receipt by the Secretary or at the pleasure of the Board of Directors. If
no such specification is made it shall be deemed effective at the pleasure of the Board of
Directors. When one or more directors shall resign from the Board effective at a future date, a
majority of the directors then in office, including those who have so resigned (prior to the
resignation being in effect), shall have power to fill such vacancy or vacancies, the vote thereon
to take effect when such resignation or resignations shall become effective, and each director so
chosen shall hold office for the unexpired portion of the term of the director whose place shall be
vacated and until his successor shall have been duly elected and qualified.
(b) At a special meeting of shareholders called for the purpose in the manner hereinabove
provided, the Board of Directors or any individual director may be removed from office, with or
without cause, and a new director or directors elected by a vote of shareholders holding a majority
of the outstanding shares entitled to vote at an election of directors.
Section 3.5 Meetings.
(a) The annual meeting of the Board of Directors shall be held immediately after the annual
shareholders meeting and at the place where such meeting is held or at the place announced by the
Chairman at such meeting. No notice of an annual meeting of the Board of Directors shall be
necessary, and such meeting shall be held for the purpose of electing officers and transacting such
other business as may lawfully come before it.
(b) Except as hereinafter otherwise provided, regular meetings of the Board of Directors shall
be held in the principal office of the corporation. Regular meetings of the Board of Directors may
also be held at any place, within or without the United States, as determined by the Chairman of
the Board or by the written consent of all directors.
(c) Special meetings of the Board of Directors may be held at any time and place within or
without the State of Florida whenever called by the Chairman of the Board or, if there is no
Chairman of the Board, by the Chief Executive Officer, or by any of the directors.
(d) Written notice of the time and place of all regular and special meetings of the Board of
Directors shall be delivered personally to each director or sent by telegram or facsimile
transmission or other form of electronic transmission at least 48 hours before the start of the
meeting, or sent by first class mail at least 120 hours before the start of the meeting. Notice of
any meeting may be waived in writing at any time before or after the meeting and will be waived by
any director by attendance thereat.
Section 3.6 Quorum and Voting.
(a) A quorum of the Board of Directors shall consist of a majority of the exact number of
directors fixed from time to time in accordance with Section 3.1 of Article III of these Bylaws,
but not less than one; provided, however, at any meeting whether a quorum be
present or otherwise, a majority of the directors present may adjourn from time to time until the
time
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fixed for the next regular meeting of the Board of Directors, without notice other than by
announcement at the meeting.
(b) At each meeting of the Board at which a quorum is present, all questions and business
shall be determined by a vote of a majority of the directors present, unless a different vote be
required by law, the corporations Articles of Incorporation or these Amended and Restated Bylaws.
(c) Any member of the Board of Directors, or of any committee thereof, may participate in a
meeting by means of conference telephone or other communication equipment by means of which all
persons participating in the meeting can hear each other, and participation in a meeting by such
means shall constitute presence in person at such meeting.
(d) The transactions of any meeting of the Board of Directors, or any committee thereof,
however called or noticed, or wherever held, shall be as valid as though had at a meeting duly held
after regular call and notice if a quorum be present and if, either before or after the meeting,
each of the directors not present shall sign a written waiver of notice, or a consent to holding
such meeting, or an approval of the minutes thereof. All such waivers, consents or approvals shall
be filed with the corporate records or made a part of the minutes of the meeting.
Section 3.7 Action Without Meeting.
Unless otherwise restricted by the corporations Articles of Incorporation or these Amended
and Restated Bylaws, any action required or permitted to be taken at any meeting of the Board of
Directors or of any committee thereof may be taken without a meeting, if all members of the Board
or of such committee, as the case may be, consent thereto in writing or by electronic transmission,
and such writing or writings or electronic transmission or transmissions are filed with the minutes
of proceedings of the Board or committee. Such filing shall be in paper form if the minutes are
maintained in paper form and shall be in electronic form if the minutes are maintained in
electronic form.
Section 3.8 Fees and Compensation.
Directors and members of committees may receive such compensation, if any, for their services,
and such reimbursement for expenses, as may be fixed or determined by resolution of the Board of
Directors.
Section 3.9 Committees.
(a) Other Committees: The Board of Directors may, from time to time, appoint such committees
as may be permitted by law. Such other committees appointed by the Board of Directors shall have
such powers and perform such duties as may be prescribed by the resolution or resolutions creating
such committee.
(b) Term: The terms of members of all committees of the Board of Directors shall expire on
the date of the next annual meeting of the Board of Directors following their appointment;
provided, that they shall continue in office until their successors are appointed. The
Board of Directors, subject to the provisions of subsection (a) of this Section 3.9, may at any
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time increase or decrease the number of members of a committee or terminate the existence of a
committee; provided, that no committee shall consist of less than one member. The
membership of a committee member shall terminate on the date of his death or voluntary resignation,
but the Board may at any time for any reason remove any individual committee member and the Board
may fill any committee vacancy created by death, resignation, removal or increase in the number of
members of the committee. The Board of Directors may designate one or more directors as alternate
members of any committee, who may replace any absent or disqualified member at any meeting of the
committee, and, in addition, in the absence or disqualification of any member of a committee, the
member or members thereof present at any meeting and not disqualified from voting, whether or not
such member or members constitute a quorum, may unanimously appoint another member of the Board of
Directors to act at the meeting in the place of any such absent or disqualified member.
(c) Meetings: Unless the Board of Directors shall otherwise provide, regular meetings of the
committees appointed pursuant to this Section 3.9 shall be held at such times and places as are
determined by the Board of Directors, or by any such committee, and when notice thereof has been
given to each member of such committee, no further notice of such regular meetings need be given
thereafter; special meetings of any such committee may be held at the principal office of the
corporation required to be maintained pursuant to Section 1.2 of Article I hereof; or at any place
which has been designated from time to time by resolution of such committee or by written consent
of all members thereof, and may be called by any director who is a member of such committee upon
written notice to the members of such committee of the time and place of such special meeting given
in the manner provided for the giving of written notice to members of the Board of Directors of the
time and place of special meetings of the Board of Directors. Notice of any special meeting of any
committee may be waived in writing at any time after the meeting and will be waived by any director
by attendance thereat. A majority of the authorized number of members of any such committee shall
constitute a quorum for the transaction of business, and the act of a majority of those present at
any meeting at which a quorum is present shall be the act of such committee.
ARTICLE IV
OFFICERS
Section 4.1 Officers Designated.
The officers of the corporation shall be a President, a Secretary and a Treasurer. The Board
of Directors or the President may also appoint a Chairman of the Board, a chief executive officer,
chief financial officer, one or more Vice-Presidents, assistant secretaries, assistant treasurers,
and such other officers and agents with such powers and duties as the Board of Directors or the
President shall deem appropriate or necessary. The order of the seniority of the Vice- Presidents
shall be in the order of their nomination unless otherwise determined by the Board of Directors.
The Board of Directors may assign such additional titles to one or more of the officers as they
shall deem appropriate. Any one person may hold any number of offices of the corporation at any
one time unless specifically prohibited therefrom by law. The salaries and other compensation of
the officers of the corporation shall be fixed by or in the manner designated by the Board of
Directors, or a committee thereof.
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Section 4.2 Tenure and Duties of Officers.
(a) General: All officers shall hold office at the pleasure of the Board of Directors and
until their successors shall have been duly elected and qualified, unless sooner removed. Any
officer elected or appointed by the Board of Directors may be removed at any time by the Board of
Directors. If the office of any officer becomes vacant for any reason, the vacancy may be filled
by the Board of Directors. Nothing in these Amended and Restated Bylaws shall be construed as
creating any kind of contractual right to employment with the corporation.
(b) Duties of the Chairman of the Board of Directors: The Chairman of the Board of Directors
(if there be such an officer appointed) when present shall preside at all meetings of the
shareholders and the Board of Directors. The Chairman of the Board of Directors shall perform such
other duties and have such other powers as the Board of Directors shall designate from time to
time.
(c) Duties of President: The President shall be the chief executive officer of the
corporation in the absence of the Chairman of the Board and shall preside at all meetings of the
shareholders and at all meetings of the Board of Directors, unless the Chairman of the Board of
Directors has been appointed and is present. The President shall perform such other duties and
have such other powers as the Board of Directors shall designate from time to time.
(d) Duties of Vice-Presidents: The Vice-Presidents, in the order of their seniority, may
assume and perform the duties of the President in the absence or disability of the President or
whenever the office of the President is vacant. The Vice-President shall perform such other duties
and have such other powers as the Board of Directors or the President shall designate from time to
time.
(e) Duties of Secretary: The Secretary shall attend all meetings of the shareholders and of
the Board of Directors and each committee thereof, and shall record all acts and proceedings
thereof in the minute book of the corporation, which may be maintained in either paper or
electronic form. The Secretary shall give notice, in conformity with these Amended and Restated
Bylaws, of all meetings of the shareholders and of all meetings of the Board of Directors and any
Committee thereof requiring notice. The Secretary shall perform such other duties and have such
other powers as the Board of Directors shall designate from time to time. The President may direct
any assistant secretary to assume and perform the duties of the Secretary in the absence or
disability of the Secretary, and each assistant secretary shall perform such other duties and have
such other powers as the Board of Directors or the President shall designate from time to time.
(f) Duties of Treasurer: The Treasurer shall keep or cause to be kept the books of account of
the corporation in a thorough and proper manner, and shall render statements of the financial
affairs of the corporation in such form and as often as required by the Board of Directors or the
President. The Treasurer, subject to the order of the Board of Directors, shall have the custody
of all funds and securities of the corporation. The Treasurer shall perform all other duties
commonly incident to his office and shall perform such other duties and have such other powers as
the Board of Directors or the President shall designate from time to time. The President may
direct any assistant treasurer to assume and perform the duties of the Treasurer in
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the absence or disability of the Treasurer, and each assistant treasurer shall perform such
other duties and have such other powers as the Board of Directors or the President shall designate
from time to time.
ARTICLE V
EXECUTION OF CORPORATE INSTRUMENTS, AND
VOTING OF SECURITIES OWNED BY THE CORPORATION
Section 5.1 Execution of Corporate Instruments.
(a) The Board of Directors may in its discretion determine the method and designate the
signatory officer or officers, or other person or persons, to execute any corporate instrument or
document, or to sign the corporate name without limitation, except where otherwise provided by law,
and such execution or signature shall be binding upon the corporation.
(b) Unless otherwise specifically determined by the Board of Directors or otherwise required
by law, formal contracts of the corporation, promissory notes, deeds of trust, mortgages and other
evidences of indebtedness of the corporation, and other corporate instruments or documents
requiring the corporate seal, and certificates of shares of stock owned by the corporation, shall
be executed, signed or endorsed by the Chairman of the Board (if there be such an officer
appointed) or by the President; such documents may also be executed by any Vice-President and by
the Secretary or Treasurer or any assistant secretary or assistant treasurer. All other
instruments and documents requiring the corporate signature but not requiring the corporate seal
may be executed as aforesaid or in such other manner as may be directed by the Board of Directors.
(c) All checks and drafts drawn on banks or other depositaries on funds to the credit of the
corporation or in special accounts of the corporation shall be signed by such person or persons as
the Board of Directors shall authorize so to do.
(d) Execution of any corporate instrument may be effected in such form, either manual,
facsimile or electronic signature, as may be authorized by the Board of Directors.
Section 5.2 Voting of Securities Owned by Corporation.
All stock and other securities of other corporations owned or held by the corporation for
itself or for other parties in any capacity shall be voted, and all proxies with respect thereto
shall be executed, by the person authorized so to do by resolution of the Board of Directors or, in
the absence of such authorization, by the Chairman of the Board (if there be such an officer
appointed), or by the President, or by any Vice-President.
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ARTICLE VI
SHARES OF STOCK
Section 6.1 Form and Execution of Certificates.
Shares of stock of the corporation shall be represented by certificates, or shall be
uncertificated shares that may be evidenced by a book-entry system maintained by the registrar of
such stock, or a combination of both. To the extent that shares are represented by certificates,
such certificates shall be in a form approved by the Board of Directors. Each certificate shall be
signed in the name of the corporation by (A) the Chairman or Vice Chairman of the Board or the
President or a Vice President and (B) the Secretary or an Assistant Secretary or the Treasurer or
an Assistant Treasurer, and sealed with the seal of the corporation (which seal may be a facsimile,
engraved or printed); provided, however, that where any such certificate is
countersigned by a transfer agent other than the corporation or one of its employees, or is
registered by a registrar other than the corporation or one of its employees, the signature of the
officers of the corporation upon such certificates may be facsimiles, engraved or printed. In case
any officer who shall have signed or whose facsimile signature has been placed upon such
certificates shall have ceased to be such officer before such certificates shall be issued, they
may nevertheless be issued by the corporation with the same effect as if such officer were still in
office at the date of their issue.
Section 6.2 Lost Certificates.
The Board of Directors may direct a new certificate or certificates (or uncertificated shares
in lieu of a new certificate) to be issued in place of any certificate or certificates theretofore
issued by the corporation alleged to have been lost or destroyed, upon the making of an affidavit
of that fact by the person claiming the certificate of stock to be lost or destroyed. When
authorizing such issue of a new certificate or certificates (or uncertificated shares in lieu of a
new certificate), the Board of Directors may, in its discretion and as a condition precedent to the
issuance thereof, require the owner of such lost or destroyed certificate or certificates, or his
legal representative, to indemnify the corporation in such manner as it shall require and/or to
give the corporation a surety bond in such form and amount as it may direct as indemnity against
any claim that may be made against the corporation with respect to the certificate alleged to have
been lost or destroyed.
Section 6.3 Transfers.
Subject to any restrictions on transfer and unless otherwise provided by the Board of
Directors, shares of stock may be transferred only on the books of the corporation by the surrender
to the corporation or its transfer agent of shares in certificated form, properly endorsed or
accompanied by a written assignment or power of attorney properly executed, with transfer stamps
(if necessary) affixed, or upon proper instructions from the holder of uncertificated shares, in
each case with such proof of the authenticity of signature as the corporation or its transfer agent
may reasonably require. Except as otherwise provided by applicable law, the corporation shall be
entitled to recognize the exclusive right of a person in whose name any share or shares stand on
the record of shareholders as the owner of such share or shares for all
16
purposes, including, without limitation, the rights to receive dividends or other
distributions and to vote as such owner, and the corporation may hold any such shareholder of
record liable for calls and assessments and the corporation shall not be bound to recognize any
equitable or legal claim to or interest in any such share or shares on the part of any other person
whether or not it shall have express or other notice thereof. Whenever any transfers of shares
shall be made for collateral security and not absolutely, and both the transferor and transferee
request the corporation to do so, such fact shall be stated in the entry of the transfer.
Section 6.4 Registered Shareholders.
The corporation shall be entitled to recognize the exclusive right of a person registered on
its books as the owner of shares to receive dividends and to vote as such owner, and shall not be
bound to recognize any equitable or other claim to or interest in such share or shares on the part
of any other person, whether or not it shall have express or other notice thereof, except as
otherwise provided by the laws of the State of Florida.
ARTICLE VII
OTHER SECURITIES OF THE CORPORATION
All bonds, debentures and other corporate securities of the corporation, other than stock
certificates, may be signed by the Chairman of the Board (if there be such an officer appointed),
or the President or any Vice-President or such other person as may be authorized by the Board of
Directors and the corporate seal impressed thereon or a facsimile of such seal imprinted thereon
and attested by the signature of the Secretary or an assistant secretary, or the Treasurer or an
assistant treasurer; provided, however, that where any such bond, debenture or
other corporate security shall be authenticated by the manual signature of a trustee under an
indenture pursuant to which such bond, debenture or other corporate security shall be issued, the
signature of the persons signing and attesting the corporate seal on such bond, debenture or other
corporate security may be the imprinted facsimile of the signatures of such persons. Interest
coupons appertaining to any such bond, debenture or other corporate security, authenticated by a
trustee as aforesaid, shall be signed by the Treasurer or an assistant treasurer of the
corporation, or such other person as may be authorized by the Board of Directors, or bear imprinted
thereon the facsimile signature of such person. In case any officer who shall have signed or
attested any bond, debenture or other corporate security, or whose facsimile signature shall appear
thereon has ceased to be an officer of the corporation before the bond, debenture or other
corporate security so signed or attested shall have been delivered, such bond, debenture or other
corporate security nevertheless may be adopted by the corporation and issued and delivered as
though the person who signed the same or whose facsimile signature shall have been used thereon had
not ceased to be such officer of the corporation.
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ARTICLE VIII
INDEMNIFICATION OF OFFICERS, DIRECTORS, EMPLOYEES AND AGENTS
Section 8.1 Right to Indemnification.
Each person who was or is a party or is threatened to be made a party to or is involved (as a
party, witness, or otherwise), in any threatened, pending, or completed action, suit, or
proceeding, whether civil, criminal, administrative, or investigative (hereinafter a Proceeding),
by reason of the fact that he, or a person of whom he is the legal representative, is or was a
director, officer, employee, or agent of the corporation or is or was serving at the request of the
corporation as a director, officer, employee, or agent of another corporation or of a partnership,
joint venture, trust, or other enterprise, including service with respect to employee benefit
plans, whether the basis of the Proceeding is alleged action in an official capacity as a director,
officer, employee, or agent or in any other capacity while serving as a director, officer,
employee, or agent (hereafter an Agent), shall be indemnified and held harmless by the
corporation to the fullest extent authorized by the Florida Business Corporation Act, as the same
exists or may hereafter be amended or interpreted (but, in the case of any such amendment or
interpretation, only to the extent that such amendment or interpretation permits the corporation to
provide broader indemnification rights than were permitted prior thereto) against all expenses,
liability, and loss (including attorneys fees, judgments, fines, ERISA excise taxes or penalties,
and amounts paid or to be paid in settlement, and any interest, assessments, or other charges
imposed thereon, and any federal, state, local, or foreign taxes imposed on any Agent as a result
of the actual or deemed receipt of any payments under this Article) reasonably incurred or suffered
by such person in connection with investigating, defending, being a witness in, or participating in
(including on appeal), or preparing for any of the foregoing in, any Proceeding (hereinafter
Expenses); provided, however, that except as to actions to enforce
indemnification rights pursuant to Section 8.3 of this Article, the corporation shall indemnify any
Agent seeking indemnification in connection with a Proceeding (or part thereof) initiated by such
person only if the Proceeding (or part thereof) was authorized by the Board of Directors of the
corporation. The right to indemnification conferred in this Article shall be a contract right.
Section 8.2 Authority to Advance Expenses.
Expenses incurred by an officer or director (acting in his capacity as such) in defending a
Proceeding shall be paid by the corporation in advance of the final disposition of such Proceeding;
provided, however, that if required by the Florida Business Corporation Act, such
Expenses shall be advanced only upon delivery to the corporation of an undertaking by or on behalf
of such director or officer to repay such amount if it shall ultimately be determined that he is
not entitled to be indemnified by the corporation as authorized in this Article or otherwise.
Expenses incurred by other Agents of the corporation (or by the directors or officers not acting in
their capacity as such, including service with respect to employee benefit plans) may be advanced
upon such terms and conditions as the Board of Directors deems appropriate. Any obligation to
reimburse the corporation for Expense advances shall be unsecured and no interest shall be charged
thereon.
18
Section 8.3 Right of Claimant to Bring Suit.
If a claim under Section 8.1 or 8.2 of this Article is not paid in full by the corporation
within 30 days after a written claim has been received by the corporation, the claimant may at any
time thereafter bring suit against the corporation to recover the unpaid amount of the claim and,
if successful in whole or in part, the claimant shall be entitled to be paid also the expense
(including attorneys fees) of prosecuting such claim. It shall be a defense to any such action
(other than an action brought to enforce a claim for expenses incurred in defending a Proceeding in
advance of its final disposition where the required undertaking has been tendered to the
corporation) that the claimant has not met the standards of conduct that make it permissible under
the Florida Business Corporation Act for the corporation to indemnify the claimant for the amount
claimed. The burden of proving such a defense shall be on the corporation. Neither the failure of
the corporation (including its Board of Directors, independent legal counsel, or its shareholders)
to have made a determination prior to the commencement of such action that indemnification of the
claimant is proper under the circumstances because he has met the applicable standard of conduct
set forth in the Florida Business Corporation Act, nor an actual determination by the corporation
(including its Board of Directors, independent legal counsel, or its shareholders) that the
claimant had not met such applicable standard of conduct, shall be a defense to the action or
create a presumption that claimant has not met the applicable standard of conduct.
Section 8.4 Provisions Nonexclusive.
The rights conferred on any person by this Article shall not be exclusive of any other rights
that such person may have or hereafter acquire under any statute, provision of the corporations
Articles of Incorporation or any agreement, vote of shareholders or disinterested directors or
otherwise, both as to action in an official capacity and as to action in another capacity while
holding such office. To the extent that any provision of the corporations Articles of
Incorporation or any agreement, or vote of the shareholders or disinterested directors is
inconsistent with these Amended and Restated Bylaws, the provision, agreement or vote shall take
precedence.
Section 8.5 Authority to Insure.
The corporation may purchase and maintain insurance to protect itself and any Agent against
any Expense, whether or not the corporation would have the power to indemnify the Agent against
such Expense under applicable law or the provisions of this Article.
Section 8.6 Survival of Rights.
The rights provided by this Article shall continue as to a person who has ceased to be an
Agent and shall inure to the benefit of the heirs, executors, and administrators of such a person.
Section 8.7 Settlement of Claims.
The corporation shall not be liable to indemnify any Agent under this Article (a) for any
amounts paid in settlement of any action or claim effected without the corporations written
consent, which consent shall not be unreasonably withheld or (b) for any judicial award if the
19
corporation was not given a reasonable and timely opportunity, at its expense, to participate
in the defense of such action.
Section 8.8 Effect of Amendment.
Any amendment, repeal, or modification of this Article shall not adversely affect any right or
protection of any Agent existing at the time of such amendment, repeal, or modification.
Section 8.9 Subrogation.
In the event of payment under this Article, the corporation shall be subrogated to the extent
of such payment to all of the rights of recovery of the Agent, who shall execute all papers
required and shall do everything that may be necessary to secure such rights, including the
execution of such documents necessary to enable the corporation effectively to bring suit to
enforce such rights.
Section 8.10 No Duplication of Payments.
The corporation shall not be liable under this Article to make any payment in connection with
any claim made against the Agent to the extent the Agent has otherwise actually received payment
(under any insurance policy, agreement, vote, or otherwise) of the amounts otherwise indemnifiable
hereunder.
ARTICLE IX
FISCAL YEAR
The fiscal year of the corporation shall begin on the first day in January of each calendar
year and end on the last day of each December following.
ARTICLE X
NOTICES
Whenever, under any provisions of these Amended and Restated Bylaws, notice is required to be
given to any shareholder, the same shall be given either (1) in writing, timely and duly deposited
in the mail, postage prepaid, and addressed to his last known post office address as shown by the
stock record of the corporation or its transfer agent, or (2) by a means of electronic transmission
that satisfies the requirements of Section 2.4(e) of these Amended and Restated Bylaws, and has
been consented to by the shareholder to whom the notice is given. Any notice required to be given
to any director may be given by either of the methods hereinabove stated, except that such notice
other than one which is delivered personally, shall be sent to such address or (in the case of
electronic communication) such e-mail address, facsimile telephone number or other form of
electronic address as such director shall have filed in writing or by electronic communication with
the Secretary of the corporation, or, in the absence of such filing, to the last known post office
address of such director. If no address of a shareholder or director be known, such notice may be
sent to the principal office of the corporation. An affidavit of mailing, executed by a duly
authorized and competent employee of the corporation
20
or its transfer agent appointed with respect to the class of stock affected, specifying the
name and address or the names and addresses of the shareholder or shareholders, director or
directors, to whom any such notice or notices was or were given, and the time and method of giving
the same, shall be conclusive evidence of the statements therein contained. All notices given by
mail, as above provided, shall be deemed to have been given as at the time of mailing and all
notices given by means of electronic transmission shall be deemed to have been given as at the
sending time recorded by the electronic transmission equipment operator transmitting the same. It
shall not be necessary that the same method of giving notice be employed in respect of all
directors, but one permissible method may be employed in respect of any one or more, and any other
permissible method or methods may be employed in respect of any other or others. The period or
limitation of time within which any shareholder may exercise any option or right, or enjoy any
privilege or benefit, or be required to act, or within which any director may exercise any power or
right, or enjoy any privilege, pursuant to any notice sent him in the manner above provided, shall
not be affected or extended in any manner by the failure of such a shareholder or such director to
receive such notice. Whenever any notice is required to be given under the provisions of the
statutes or of the corporations Articles of Incorporation, or of these Amended and Restated
Bylaws, a waiver thereof in writing signed by the person or persons entitled to said notice, or a
waiver by electronic transmission by the person entitled to notice, whether before or after the
time stated therein, shall be deemed equivalent thereto. Whenever notice is required to be given,
under any provision of law or of the corporations Articles of Incorporation or these Amended and
Restated Bylaws, to any person with whom communication is unlawful, the giving of such notice to
such person shall not be required and there shall be no duty to apply to any governmental authority
or agency for a license or permit to give such notice to such person. Any action or meeting which
shall be taken or held without notice to any such person with whom communication is unlawful shall
have the same force and effect as if such notice had been duly given. In the event that the action
taken by the corporation is such as to require the filing of a certificate under any provision of
the Florida Business Corporation Act, the certificate shall state, if such is the fact and if
notice is required, that notice was given to all persons entitled to receive notice except such
persons with whom communication is unlawful.
ARTICLE XI
AMENDMENTS
The Board of Directors shall have the authority to repeal, alter or amend these Amended and
Restated Bylaws or adopt new Bylaws (including, without limitation, the amendment of any Amended
and Restated Bylaws setting forth the number of directors who shall constitute the whole Board of
Directors) by unanimous written consent or at any annual, regular, or special meeting by the
affirmative vote of a majority of the whole number of directors, subject to the power of the
shareholders to change or repeal such Bylaws and provided that the Board of Directors shall not
make or alter any Bylaws fixing the qualifications, classifications or term of office of directors.
21
EX-31.1
EXHIBIT 31.1
CERTIFICATION
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I, David Aviezer, certify that: |
1. |
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I have reviewed this quarterly report on Form 10-Q of Protalix BioTherapeutics, Inc.; |
2. |
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Based on my knowledge, this report does not contain any untrue statement of a material fact
or omit to state a material fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not misleading with respect to the period
covered by this report; |
3. |
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Based on my knowledge, the financial statements, and other financial information included in
this report, fairly present in all material respects the financial condition, results of
operations and cash flows of the registrant as of, and for, the periods presented in this
report; |
4. |
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The registrants other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and
15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d-15(f)) for the registrant and have: |
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(a) |
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Designed such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries, is
made known to us by others within those entities, particularly during the period in
which this report is being prepared; |
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(b) |
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Designed such internal control over financial reporting, or caused such
internal control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with generally
accepted accounting principles; |
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(c) |
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Evaluated the effectiveness of the registrants disclosure controls and
procedures and presented in this report our conclusions about the effectiveness of the
disclosure controls and procedures, as of the end of the period covered by this report
based on such evaluation; and |
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(d) |
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Disclosed in this report any change in the registrants internal control over
financial reporting that occurred during the registrants most recent fiscal quarter
(the registrants fourth fiscal quarter in the case of an annual report) that has
materially affected, or is reasonably likely to materially affect, the registrants
internal control over financial reporting; and |
5. |
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The registrants other certifying officer and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and the
audit committee of the registrants board of directors (or persons performing the equivalent
functions): |
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a) |
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All significant deficiencies and material weaknesses in the design or operation of
internal control over financial reporting which are reasonably likely to adversely affect
the registrants ability to record, process, summarize and report financial information;
and |
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b) |
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Any fraud, whether or not material, that involves management or other employees who
have a significant role in the registrants internal control over financial reporting. |
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Date: August 8, 2008
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David Aviezer, Ph.D. |
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President and Chief Executive Officer |
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EX-31.2
EXHIBIT 31.2
CERTIFICATION
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I, Yossi Maimon, certify that: |
1. |
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I have reviewed this quarterly report on Form 10-Q of Protalix BioTherapeutics, Inc.; |
2. |
|
Based on my knowledge, this report does not contain any untrue statement of a material fact
or omit to state a material fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not misleading with respect to the period
covered by this report; |
3. |
|
Based on my knowledge, the financial statements, and other financial information included in
this report, fairly present in all material respects the financial condition, results of
operations and cash flows of the registrant as of, and for, the periods presented in this
report; |
4. |
|
The registrants other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and
15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d-15(f)) for the registrant and have: |
|
(a) |
|
Designed such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries, is
made known to us by others within those entities, particularly during the period in
which this report is being prepared; |
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(b) |
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Designed such internal control over financial reporting, or caused such
internal control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with generally
accepted accounting principles; |
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(c) |
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Evaluated the effectiveness of the registrants disclosure controls and
procedures and presented in this report our conclusions about the effectiveness of the
disclosure controls and procedures, as of the end of the period covered by this report
based on such evaluation; and |
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(d) |
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Disclosed in this report any change in the registrants internal control over
financial reporting that occurred during the registrants most recent fiscal quarter
(the registrants fourth fiscal quarter in the case of an annual report) that has
materially affected, or is reasonably likely to materially affect, the registrants
internal control over financial reporting; and |
5. |
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The registrants other certifying officer and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and the
audit committee of the registrants board of directors (or persons performing the equivalent
functions): |
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a) |
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All significant deficiencies and material weaknesses in the design or operation of
internal control over financial reporting which are reasonably likely to adversely affect
the registrants ability to record, process, summarize and report financial information;
and |
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b) |
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Any fraud, whether or not material, that involves management or other employees who
have a significant role in the registrants internal control over financial reporting. |
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Date: August 8, 2008
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Yossi Maimon |
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Chief Financial Officer, Treasurer |
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EX-32.1
EXHIBIT 32.1
PROTALIX BIOTHERAPEUTICS, INC.
CERTIFICATION
In connection with the quarterly report of Protalix BioTherapeutics, Inc. (the Company) on Form
10-Q for the period ended June 30, 2008 as filed with the Securities and Exchange Commission (the
Report), I, David Aviezer, President and Chief Executive Officer of the Company, hereby certify
as of the date hereof, solely for purposes of Title 18, Chapter 63, Section 1350 of the United
States Code, that to the best of my knowledge:
(1) the Report fully complies with the requirements of Section 13(a) or 15(d), as applicable,
of the Securities Exchange Act of 1934; and
(2) the information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of the Company at the dates and for the periods
indicated.
This Certification has not been, and shall not be deemed, filed with the Securities and Exchange
Commission.
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Date: August 8, 2008
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/s/ David Aviezer
David Aviezer, Ph.D.
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President and Chief Executive Officer |
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EX-32.2
EXHIBIT 32.2
PROTALIX BIOTHERAPEUTICS, INC.
CERTIFICATION
In connection with the quarterly report of Protalix BioTherapeutics, Inc. (the Company) on Form
10-Q for the period ended June 30, 2008 as filed with the Securities and Exchange Commission (the
Report), I, Yossi Maimon, Vice President and Chief Financial Officer of the Company, hereby
certify as of the date hereof, solely for the purposes of Title 18, Chapter 63, Section 1350 of the
United States Code, that to the best of my knowledge:
(1) the Report fully complies with the requirements of Section 13(a) or 15(d), as applicable,
of the Securities Exchange Act of 1934; and
(2) the information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of the Company at the dates and for the periods
indicated.
This Certification has not been, and shall not be deemed, filed with the Securities and Exchange
Commission.
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Date: August 8, 2008 |
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Yossi Maimon |
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Vice President and Chief Financial Officer |
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