10-Q/A
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q/A
(Amendment No. 1)
(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 September 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
of incorporation or organization) |
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(I.R.S. Employer
Identification No.) |
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2 Snunit Street
Science Park
POB 455 |
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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 |
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Smaller reporting company o |
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(Do not check if a smaller reporting company) |
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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 November 1, 2008, approximately 75,930,235 shares of the Registrants common stock, $0.001
par value, were outstanding.
FORM 10-Q/A
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 Quarterly 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 any of 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 our intellectual property rights 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
EXPLANATORY NOTE
The Company is restating its financial statements for the three month and nine month periods ended
September 30, 2007 by amending its Quarterly Report on Form 10-Q for the quarterly period ended
September 30, 2008 to change the accounting treatment of certain stock-based compensation of
non-employees required by SFAS 123(R), Share-Based Payment, or SFAS 123R, for certain transactions
with nonemployees.
All amendments and restatements to the financial statements are non-cash in nature.
An explanation of the change in accounting treatment and its impact on the Companys financial
statements is contained in Note 2 to the financial statements contained in Item 1 of this report.
The following sections of this Form 10-Q/A have been amended to reflect the restatement.
Part I Item 1 Financial Statements
Part I Item 2 Managements Discussion and Analysis of Financial Condition and Results of
Operations
Other than as stated above, this Form 10-Q/A continues to speak as of September 30, 2008 or (where
applicable) as of the date of the filing of the original Form 10-Q, and the information in this
Form 10-Q/A does not modify or update any other item or disclosure in the original Form 10-Q or
reflect any other events occurring after the filing of the original Form 10-Q.
This amended Form 10-Q/A should be read in conjunction with any periodic reports that have been
filed subsequent to the date of the filing of the original Form 10-Q.
iii
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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September 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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$ |
46,045 |
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$ |
61,813 |
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Accounts receivable |
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2,913 |
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1,354 |
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Total current assets |
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48,958 |
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63,167 |
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FUNDS IN RESPECT OF EMPLOYEE
RIGHTS UPON RETIREMENT |
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657 |
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464 |
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PROPERTY AND EQUIPMENT, NET |
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6,273 |
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4,506 |
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Total assets |
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$ |
55,888 |
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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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$ |
2,067 |
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$ |
899 |
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Other |
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2,332 |
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2,863 |
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Total current liabilities |
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4,399 |
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3,762 |
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LIABILITY FOR EMPLOYEE RIGHTS
UPON RETIREMENT |
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994 |
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690 |
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Total liabilities |
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5,393 |
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4,452 |
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SHAREHOLDERS EQUITY |
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50,495 |
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63,685 |
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Total liabilities and
shareholders equity |
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$ |
55,888 |
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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 and per share data)
(Unaudited)
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Period from |
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December 27, 1993* |
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Nine Months Ended September 30, |
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Three Months Ended September 30, |
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through |
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2008 |
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2007 |
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2008 |
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2007 |
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September 30, 2008 |
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(restated) |
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(restated) |
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(restated) |
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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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$ |
15,817 |
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$ |
10,246 |
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$ |
6,133 |
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$ |
3,845 |
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48,119 |
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less grants |
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(3,244 |
) |
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(1,466 |
) |
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(729 |
) |
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(385 |
) |
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(9,431 |
) |
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12,573 |
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8,780 |
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5,404 |
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3,460 |
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38,688 |
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GENERAL AND ADMINISTRATIVE EXPENSES (2) |
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5,306 |
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21,800 |
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1,314 |
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9,045 |
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34,902 |
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OPERATING LOSS |
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17,879 |
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30,580 |
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6,718 |
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12,505 |
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72,966 |
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FINANCIAL INCOME NET |
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(2,041 |
) |
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(1,191 |
) |
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(222 |
) |
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(685 |
) |
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(4,489 |
) |
OTHER INCOME |
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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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15,838 |
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29,383 |
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6,496 |
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11,820 |
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68,471 |
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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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$ |
15,838 |
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$ |
29,383 |
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$ |
6,496 |
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$ |
11,820 |
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$ |
68,434 |
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NET LOSS PER SHARE OF COMMON STOCK BASIC AND DILUTED: |
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$ |
0.21 |
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$ |
0.45 |
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$ |
0.09 |
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$ |
0.18 |
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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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75,879,778 |
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65,275,435 |
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75,924,657 |
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65,674,568 |
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(1) Includes share-based compensation |
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965 |
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2,688 |
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293 |
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910 |
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6,349 |
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(2) Includes share-based compensation |
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1,680 |
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19,543 |
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185 |
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8,277 |
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22,680 |
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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 (restated): |
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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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|
411 |
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Conversion of convertible preferred shares into
common stock |
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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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240 |
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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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|
|
|
|
|
|
26,394 |
|
|
|
|
|
|
|
26,394 |
|
Net loss for the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(52,633 |
) |
|
|
(52,633 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007 (restated) |
|
|
75,775,439 |
|
|
|
|
|
|
|
76 |
|
|
|
|
|
|
|
|
|
|
|
116,205 |
|
|
|
(52,596 |
) |
|
|
63,685 |
|
Changes during the nine month period ended
September 30, 2008 (Unaudited): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted common stock issued for future services |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3 |
) |
|
|
|
|
|
|
(3 |
) |
Share-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,648 |
|
|
|
|
|
|
|
2,648 |
|
Exercise (includes Net Exercise) of options
granted to employees |
|
|
154,796 |
|
|
|
|
|
|
|
* |
|
|
|
|
|
|
|
|
|
|
|
3 |
|
|
|
|
|
|
|
3 |
|
Net loss for the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(15,838 |
) |
|
|
(15,838 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at September 30, 2008 (Unaudited) (restated) |
|
|
75,930,235 |
|
|
|
|
|
|
$ |
76 |
|
|
|
|
|
|
|
|
|
|
$ |
118,853 |
|
|
$ |
(68,434 |
) |
|
$ |
50,495 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
Represents an amount less than $1. |
|
(1) |
|
Incorporation date. See Note 1a. |
|
(2) |
|
Common Stock, $0.001 par value; Authorized as of December 31, 2007 and September 30, 2008 -
150,000,000 shares. |
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)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
|
December 27, 1993* |
|
|
|
Nine Months Ended September 30, |
|
|
through |
|
|
|
2008 |
|
|
2007 |
|
|
September 30, 2008 |
|
|
|
|
|
|
|
(restated) |
|
|
(restated) |
|
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss for the period |
|
$ |
(15,838 |
) |
|
$ |
(29,383 |
) |
|
$ |
(68,434 |
) |
Adjustments required to reconcile net loss to net
cash used in operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative effect of change in accounting principle |
|
|
|
|
|
|
|
|
|
|
(37 |
) |
Share based compensation |
|
|
2,645 |
|
|
|
22,231 |
|
|
|
29,029 |
|
Financial income, net (principal differences
relate to currency transaction gains/losses) |
|
|
(823 |
) |
|
|
(417 |
) |
|
|
(1,629 |
) |
Depreciation and impairment of fixed assets |
|
|
927 |
|
|
|
530 |
|
|
|
2,866 |
|
Changes in accrued liability for employee rights
upon retirement |
|
|
304 |
|
|
|
193 |
|
|
|
994 |
|
Gain on amounts funded in respect of employee
rights upon retirement |
|
|
(70 |
) |
|
|
(34 |
) |
|
|
(174 |
) |
Gain on sale of fixed assets |
|
|
|
|
|
|
(6 |
) |
|
|
(6 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Increase in accounts receivable |
|
|
(1,243 |
) |
|
|
(264 |
) |
|
|
(2,388 |
) |
Increase in accounts payable and accruals |
|
|
322 |
|
|
|
153 |
|
|
|
3,329 |
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
$ |
(13,776 |
) |
|
$ |
(6,997 |
) |
|
$ |
(36,450 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of property and equipment |
|
$ |
(2,643 |
) |
|
$ |
(1,072 |
) |
|
$ |
(8,465 |
) |
Investment grant received in respect of fixed assets |
|
|
|
|
|
|
|
|
|
|
38 |
|
Investment in restricted cash deposit |
|
|
(175 |
) |
|
|
|
|
|
|
(222 |
) |
Proceeds from sale of property and equipment |
|
|
|
|
|
|
10 |
|
|
|
11 |
|
Amounts funded in respect of employee rights upon
retirement |
|
|
(123 |
) |
|
|
(89 |
) |
|
|
(654 |
) |
Amounts paid in respect of employee rights upon
retirement |
|
|
|
|
|
|
14 |
|
|
|
171 |
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
$ |
(2,941 |
) |
|
$ |
(1,137 |
) |
|
$ |
(9,121 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
) |
|
|
|
|
|
|
74,059 |
|
Exercise of options and warrants |
|
|
3 |
|
|
$ |
12,913 |
|
|
|
14,417 |
|
Deferred issuance cost |
|
|
|
|
|
|
(21 |
) |
|
|
|
|
Merger with a wholly owned subsidiary of the Company,
net of issuance cost |
|
|
|
|
|
|
(104 |
) |
|
|
237 |
|
|
|
|
|
|
|
|
|
|
|
Net cash (used) provided by financing activities |
|
$ |
(53 |
) |
|
$ |
12,788 |
|
|
$ |
89,858 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EFFECT OF EXCHANGE RATE CHANGES
ON CASH |
|
$ |
1,002 |
|
|
$ |
408 |
|
|
$ |
1,758 |
|
|
|
|
|
|
|
|
|
|
|
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS |
|
|
(15,768 |
) |
|
|
5,062 |
|
|
|
46,045 |
|
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF
PERIOD |
|
|
61,813 |
|
|
|
15,378 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD |
|
$ |
46,045 |
|
|
$ |
20,440 |
|
|
$ |
46,045 |
|
|
|
|
|
|
|
|
|
|
|
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)
(Unaudited)
(Continued) 2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
|
December 27, |
|
|
|
|
|
|
|
|
|
|
|
1993* |
|
|
|
|
|
|
|
|
|
|
|
through |
|
|
|
Nine Months Ended September 30, |
|
|
September 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
|
|
|
|
(restated) |
|
|
(restated) |
|
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 |
|
$ |
717 |
|
|
$ |
956 |
|
|
$ |
717 |
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance cost not yet paid against deferred issuance cost |
|
|
|
|
|
$ |
386 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
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 and per 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 approximately 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
conjunction with the audited consolidated |
6
PROTALIX BIOTHERAPEUTICS, INC.
(a development stage company)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
NOTE 1 SIGNIFICANT ACCOUNTING POLICIES (Continued):
|
|
|
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. |
|
|
c. |
|
Net loss per share |
|
|
|
|
Basic and diluted loss per share (LPS) are computed by dividing net loss by the
weighted average number of shares of the 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 12,233,626 and 10,968,132 shares of Common Stock for the
nine months ended September 30, 2007 and 2008, respectively, and 11,887,934 and
11,101,670 shares of Common Stock for the three months ended September 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 and per 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 and per share data)
(Unaudited)
NOTE 1 SIGNIFICANT ACCOUNTING POLICIES (Continued):
|
e. |
|
Reclassifications |
|
|
|
|
Certain figures in respect of prior years have been reclassified to conform to the
current year presentation. |
NOTE 2 RESTATEMENT OF CONSOLIDATED FINANCIAL STATEMENTS
The Company has restated its consolidated balance sheet at December 31, 2007, statements of
operations, changes in shareholders equity and cash flows for the year ended December 31,
2007, the quarters ended March 31, 2007 and September 30, 2007 and for the period from
December 27, 1993 through September 30, 2008, to change the accounting treatment of certain
stock-based compensation of non-employees as required by applicable accounting guidance.
Statement of Financial Accounting Standards No. 123 (Revised 2004) Share-Based Payment
(SFAS 123R) requires the use of the fair-value-based method to measure the value of
stock-based compensation. In the Companys application of SFAS 123R, the Company took the
position that an active market for its Common Stock did not exist for the first quarter of
2007, and that better information existed for the first and third quarters of 2007, due to
the limited public float and trading volume in the market. The Company used alternative
valuation methods to calculate the fair value of the Common Stock underlying certain
stock-based compensation awards granted to non-employees during the first and third quarters
of 2007. For the third quarter of 2007, the Company used the public offering price of the
shares of its Common Stock sold in the underwritten public offering completed by the Company
on October 25, 2007 as an alternative valuation method for the stock-based compensation.
For purposes of the second quarter of 2007, the Company used the traded market value of the
Common Stock to calculate the fair value of the Common Stock underlying certain stock-based
compensation awards granted to non-employees because the Company did not believe that there
was a preferred, alternative valuation mechanism available for that quarter. However, the
Company concluded that it must rely on the traded market value of the Common Stock for the
first and third quarters of 2007. The Company recalculated the compensation expense for
non-employees for the first and third quarters of 2007 based on the traded market price of
the Common Stock on the applicable measurement dates and determined that the resulting
increase to the compensation expense for the applicable periods was material. On that
basis, the Company recommended to the Audit Committee that a restatement is required.
SFAS 123R requires that share-based transactions with nonemployees to be measured based on
the fair value of the goods or services received or the fair value of the equity
instruments, whichever is more reliably measurable. EITF 96-18 specifies that the
measurement date for such share-based transactions should be the earlier of (1) a
performance commitment or (2) the date at which the counterpartys performance is complete.
The Company had previously issued 2,148,569 shares of equity instruments (stock options and
restricted Common Stock) whose terms indicated that performance was not complete until the
applicable vesting requirements were fulfilled. Out of such options, 387,542 options did
not vest at all in any quarter of 2007. Consequently, the Company adjusted the recorded
expenses of such options at the end of each of the quarters of 2007 based upon the traded
price of the Common Stock at the end of each quarter.
When preparing the consolidated financial statements for the third quarter of 2007, the
Companys management utilized a fair value of its Common Stock of $5.00 per share. The
reported traded price of the Common Stock on the NYSE Alternext US was $34.56 at the end of
the third quarter of 2007. The Company has subsequently concluded that it should have used
the reported traded prices as the valuation methodology for those equity instruments.
Accordingly, the Company has restated the amounts previously reported for share-based
compensation.
9
PROTALIX BIOTHERAPEUTICS, INC.
(a development stage company)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
NOTE 2 RESTATEMENT OF CONSOLIDATED FINANCIAL STATEMENTS (Continued):
For individual tranches of options for which the applicable vesting/service period crosses
interim periods (such as the options issued to the nonemployee), the Company remeasures
the tranches at the end of each period until the final vesting date of the tranche. The
Company calculates the proportionate compensation expense for outstanding options by
dividing the number of months in the calculation period, generally, a quarter, by the
number of months in the vesting period and multiplying the result by the portion of the
option vests during the vesting period. For purposes of determining the fair value of the
options, the Company uses the closing sale price of the Common Stock on the NYSE Alternext
US (then, the American Stock Exchange) on the calculation date. As the calculation for
the third quarter of 2007 included an adjustment of the compensation expense recorded for
the first six months of 2007, the compensation expense for outstanding options held by
nonemployees for the first six months of 2007, as measured on June 30, 2007, was
remeasured using the reported traded price on September 30, 2007.
In the financial statements originally prepared for the third quarter of 2007, the
Company did not remeasure the compensation expenses recorded for nonemployees in the
manner described above. Rather, the Company amortized the compensation expense for the
third quarter of 2007 individually based on the fair value of the Common Stock on the last
day of the quarter without remeasuring previous quarters expense. The Company has remeasured the compensation expenses for nonemployees
as of the end of the third quarter of 2007 in the restated financial statements included
in this amended Quarterly Report on Form 10-Q/A.
The following is a summary of the effects of the restatement on the Companys consolidated
financial statements (all amounts presented are in thousands, except per share data):
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2007
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As Reported |
|
Adjustment |
|
As Restated |
Research and development Expenses, Net (1) |
|
$ |
8,071 |
|
|
$ |
709 |
|
|
$ |
8,780 |
|
General and Administrative Expenses (2) |
|
|
10,476 |
|
|
|
11,324 |
|
|
|
21,800 |
|
Operating Loss |
|
|
18,547 |
|
|
|
12,033 |
|
|
|
30,580 |
|
Net Loss for the Period |
|
|
17,350 |
|
|
|
12,033 |
|
|
|
29,383 |
|
Net Loss Per Share of Common Stock Basic and Diluted |
|
|
0.27 |
|
|
|
0.18 |
|
|
|
0.45 |
|
|
(1) Includes share-based compensation |
|
|
1,979 |
|
|
|
709 |
|
|
|
2,688 |
|
(2) Includes share-based compensation |
|
|
8,219 |
|
|
|
11,324 |
|
|
|
19,543 |
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE THREE MONTHS ENDED SEPTEMBER 30,
2007 (unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As Reported |
|
Adjustment |
|
As Restated |
Research and development Expenses, Net (1) |
|
$ |
3,445 |
|
|
$ |
15 |
|
|
$ |
3,460 |
|
General and Administrative Expenses (2) |
|
|
1,986 |
|
|
|
7,059 |
|
|
|
9,045 |
|
Operating Loss |
|
|
5,431 |
|
|
|
7,074 |
|
|
|
12,505 |
|
Net Loss for the Period |
|
|
4,746 |
|
|
|
7,074 |
|
|
|
11,820 |
|
Net Loss Per Share of Common Stock Basic and Diluted |
|
|
0.07 |
|
|
|
0.11 |
|
|
|
0.18 |
|
|
(1) Includes share-based compensation |
|
|
895 |
|
|
|
15 |
|
|
|
910 |
|
(2) Includes share-based compensation |
|
|
1,218 |
|
|
|
7,059 |
|
|
|
8,277 |
|
10
PROTALIX BIOTHERAPEUTICS, INC.
(a development stage company)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
NOTE 2 RESTATEMENT OF CONSOLIDATED FINANCIAL STATEMENTS (Continued):
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2007
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As Reported |
|
Adjustment |
|
As Restated |
Net loss for the period |
|
$ |
(17,350 |
) |
|
$ |
(12,033 |
) |
|
$ |
(29,383 |
) |
Adjustments required to
reconcile net loss to net
cash used in operating
activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Share based compensation |
|
|
10,198 |
|
|
|
12,033 |
|
|
|
22,231 |
|
The restatement did not result in a change in the Companys previously reported cash flows
from operating activities, or total cash and cash equivalents shown in the Companys
consolidated financial statements for the nine months ended September 30, 2007.
NOTE 3 STOCK TRANSACTIONS
|
a. |
|
During the nine months ended September 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 4 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. |
11
PROTALIX BIOTHERAPEUTICS, INC.
(a development stage company)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
NOTE 4 COMMITMENTS (Continued):
|
b. |
|
During the nine months ended September 30, 2008, the Company entered into
contracts with certain third parties in connection with certain clinical services. The
aggregate fees payable by the Company during the life of the agreements are equal to
approximately $1.64 million. |
NOTE 5 FAIR VALUE
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:
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.
Level 2: Observable prices that are based on inputs not quoted on active markets,
but corroborated by market data.
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.
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.
NOTE 6 SUBSEQUENT EVENTS
In October 2008, the Company granted an option to purchase 160,000 shares of Common Stock to
an officer of the Company with an exercise price equal to $2.35 per share. The option vests
over a four-year period and is exercisable over a 10-year period commencing on the date of
grant. The Company estimated the fair value of the option on the date of the grant using
the Black-Scholes option-pricing model to be approximately $148, based on the following
assumptions: dividend yield of 0% for all years; expected volatility of 62.5%; risk-free
interest rates of 3.58%; and expected life of six years.
12
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 Quarterly Report on 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 this Quarterly Report on Form 10-Q and 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.
Restatement
On February 23, 2009, our management concluded, with the concurrence of the Audit Committee of
our Board of Directors, or the Audit Committee, to amend and restate our financial statements for
the year ended December 31, 2007, and each of the fiscal quarters of 2007. We have restated our
consolidated balance sheet at December 31, 2007, statements of operations, changes in shareholders
equity and cash flows for the year ended December 31, 2007, the three months and nine months ended
September 30, 2007 and for the period from December 27, 1993 through September 30, 2008, to change
the accounting treatment of certain stock-based compensation of non-employees required by
applicable accounting guidance Statement of Financial Accounting Standards No. 123 (Revised 2004)
Share-Based Payment, or SFAS 123R. See Note 2 to the consolidated financial statements for
further information.
All amendments and restatements to the financial statements are non-cash in nature.
SFAS 123R requires the use of the fair-value-based method to measure the value of
stock-based compensation. In our application of SFAS 123R in the financial statements included in
the Annual Report on Form 10-K for the year ended December 31, 2007 and the Quarterly Reports on
Form 10-Q for the quarters ended March 31, 2007, June 30, 2007 and September 30, 2007, we took the
position that an active market for our common stock did not exist for the first quarter of
2007, and that better information existed for the first and third
quarters of 2007, due to the limited public float and trading volume in the market. We used alternative
valuation methods to calculate the fair value of the common stock underlying certain stock-based
compensation awards granted to nonemployees during the first and third quarters of 2007. We
determined the fair value of stock-based compensation awards granted to nonemployees that vested
during the first quarter of 2007 based on a retrospective valuation of our common stock conducted
by a third-party specialist. Based on that valuation, we fixed the fair value of the common stock
underlying stock-based compensation awards granted to nonemployees at March 31, 2007 at $6.19
per share. For the second quarter of 2007, we used the traded market value of the common stock to
calculate the fair value of the common stock underlying stock-based compensation awards granted to
non-employees because we did not believe that there was a better alternative valuation mechanism
available for that quarter. We determined that the fair value of the shares of common stock
underlying stock-based compensation awards granted to nonemployees that vested during the third
quarter of 2007 was $5.00 per share, which was the public offering price of the common stock in the
underwritten public offering we completed on October 25, 2007. However, we concluded that we must rely on the traded market value of the common stock. We
recalculated the compensation expense for non-employees in 2007 based on the traded market price of
the common stock on the applicable measurement dates and determined that the resulting increase to
the compensation expense for the applicable periods was material. On that basis, we recommended to
the Audit Committee that a restatement is required.
SFAS 123R requires that share-based transactions with nonemployees to be measured based on the
fair value of the goods or services received or the fair value of the equity instruments, whichever
is more reliably measurable. EITF 96-18, Accounting for Equity Instruments That Are Issued to
Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services, specifies
that the measurement date for such share-based transactions should be the earlier of (1) a
performance commitment or (2) the date at which the counterpartys performance is complete. We had
previously issued 2,148,569 shares of equity instruments (stock options and restricted common
stock) whose terms indicated that performance was not complete until the applicable vesting
13
requirements were fulfilled. Accordingly, the measurement of the share-based compensation
expense was determined based on the fair value of those equity instruments at each quarterly
vesting date.
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. Enzyme replacement therapy is a medical treatment in which
recombinant enzymes are 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, which is used in 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 $933 million for the nine months ended September 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, which
is a 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. Our product pipeline currently includes 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 first half of 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 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. In addition, we are
continuously evaluating potential strategic marketing partnerships.
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
14
connection with its research and development, including the clinical development of prGCD. At
September 30, 2008, we had an accumulated deficit of $68.4 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 September 30, 2008 compared to the three months ended September 30, 2007
Research and Development Expenses
Research and development expenses were $6.1 million for the three months ended September 30,
2008, an increase of $2.3 million, or 60%, from $3.8 million for the three months ended September
30, 2007. The increase resulted primarily from the increase of $1.9 million in salaries for new
and existing employees and related consulting, sub contractors and the costs of materials
associated with research and development. The increase is mainly due to the costs we incurred in
connection with our phase III clinical trial of prGCD, which we commenced during the third quarter
of 2007. Research and development expenses were offset by grants of $729,000 from the Office of
the Chief Scientist of the Israeli Ministry of Industry, Trade and Labor, or the OCS, during the
three months ended September 30, 2008, an increase of $344,000, or 89%, compared to grants equal to
$385,000 received from the OCS during the three months ended September 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 the trial and
chose to continue the treatment.
General and Administrative Expenses
General and administrative expenses were $1.3 million for the three months ended September 30,
2008, a decrease of $7.7 million, or 86%, from $9.0 million for the three months ended September
30, 2007. The decrease resulted primarily from a $8.0 million decrease in share-based compensation
which was the result of 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 September 30, 2008.
Financial Expenses and Income
Financial income was $222,000 for the three months ended September 30, 2008, a decrease of
$463,000, or 68%, from $685,000 for the three months ended September 30, 2007. The decrease
resulted primarily from the devaluation of the Dollar against the New Israeli Shekel, or the NIS,
in the three months ended September 30, 2007, compared to the devaluation of the NIS in the three
months ended on September 30, 2008. The decrease was partially offset by the higher interest
income earned during the three months ended September 30, 2008. The increase was a result of our
higher cash balance during that period.
15
Nine months ended September 30, 2008 compared to the nine months ended September 30, 2007
Research and Development Expenses
Research and development expenses were $15.8 million for the nine months ended September 30,
2008, an increase of $5.6 million, or 55%, from $10.2 million for the nine months ended September
30, 2007. The increase resulted primarily from the increase of $5.1 million in salaries for new
and existing employees, related consulting and the costs of materials associated with research and
development. Research and development expenses were offset by grants of $3.2 million from the OCS,
during the nine months ended September 30, 2008, an increase of $1.8 million, or 121%, compared to
grants equal to $1.5 million received from the OCS during the nine months ended September 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 the trial and chose to continue the treatment.
General and Administrative Expenses
General and administrative expenses were $5.3 million for the nine months ended September 30,
2008, a decrease of $16.5 million, or 76%, from $21.8 million for the nine months ended September
30, 2007. The decrease resulted primarily from a $17.9 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
nine-month period ended September 30, 2008.
Financial Expenses and Income
Financial income was $2.0 million for the nine months ended September 30, 2008, an increase of
$850,000, or 71%, from $1.2 million for the nine months ended September 30, 2007. The increase
resulted primarily from a higher balance of cash and cash equivalents as of September 30, 2008,
which primarily resulted from the interest income earned on the proceeds generated from the
underwritten public offering we completed 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
approximately the next 24 months.
Cash Flows
Net cash used in operations was $13.8 million for the nine months ended September 30, 2008.
The net loss for the nine months ended September 30, 2008 of $15.8 million was partially offset by
$2.6 million of non-cash share-based compensation. Net cash used in investing activities for the
nine months ended September 30, 2008 was $2.9 million and consisted primarily of purchases of
property and equipment. Net cash used in financing activities for the nine months ended September
30, 2008 was $53,000, consisting of expenses paid during such period in connection with the October
2007 underwritten offering.
16
Net cash used in operations was $7.0 million for the nine months ended September 30, 2007.
The net loss for the nine months ended September 30, 2007 of $29.4 million was partially offset by
$22.2 million of non-cash share-based compensation. Net cash used in investing activities for the
nine months ended September 30, 2007 was $1.1 million and consisted primarily of purchases of
property and equipment. Net cash provided by financing activities for the nine months ended
September 30, 2007 was $12.8 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 and add infrastructure to support the
general growth of our company. 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
approximately 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
nine months ended September 30, 2008 or the nine months ended September 30, 2007.
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 nine months ended September 30, 2008 or the nine
months ended September 30, 2007.
17
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements as of each of September 30, 2008 and September 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.
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,
18
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 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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Nine months ended |
|
Year ended |
|
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September 30, |
|
December 31, |
|
|
2008 |
|
2007 |
|
2007 |
Average rate for period |
|
|
3.5130 |
|
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4.1628 |
|
|
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4.1081 |
|
Rate at period end |
|
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3.4210 |
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4.0130 |
|
|
|
3.8460 |
|
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.
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
19
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
20
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 September 30,
2008 that has materially affected, or that is reasonably likely to materially affect, our internal
control over financial reporting.
Management Consideration of Restatement
On February 23, 2009, our management concluded, with the concurrence of the Audit Committee of our
Board of Directors to amend and restate our financial statements for the year ended December 31,
2007, and the first three fiscal quarters of 2007 to change the accounting treatment of certain
stock-based compensation of non-employees required by SFAS 123R for certain transactions with
nonemployees. The change in accounting treatment affected our consolidated balance sheet at
December 31, 2007, statements of operations, changes in shareholders equity and cash flows for the
year ended December 31, 2007, the quarters ended March 31, 2007 and September 30, 2007 and for the
period from December 27, 1993 through September 30, 2008. As a result of the effect of the change
in accounting treatment on our consolidated financial statements, we have restated our previously
issued condensed consolidated financial statements for the year ended December 31, 2007 in our
Annual Report on Form 10-K for the year ended December 31, 2008, and for each of the first three
fiscal quarters of 2008.
In coming to the conclusion that our disclosure controls and procedures and our internal controls
over financial reporting were effective as of the date of this Report, our management considered,
among other things, its decision to restate our financial statements in connection with its
calculation of stock-based compensation awards. Our Chief Executive Officer and Chief Financial
Officer determined that they needed to change the accounting treatment. However, the need to
restate our previously issued financial statements did not constitute a material weakness as of the
date of this Report. They have determined that, as of the date of this Report, there were controls
designed and in place to prevent or detect a material misstatement and therefore, there was no
reasonable possibility that the computation of stock-based compensation awards will be materially
misstated.
21
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.
We currently have no product revenues and will need to raise additional capital to operate our
business, which may not be available on favorable terms, or at all, and which will have a dilutive
effect on our shareholders.
To date, we have generated no revenues from product sales and only minimal revenues from
research and development services and other fees. Our accumulated deficit as of September 30, 2008
was $58.8 million. For the years ended December 31, 2007, 2006 and 2005, we had net losses of
$22.5 million, $9.4 million and $5.7 million, respectively, primarily as a result of expenses
incurred through a combination of research and development activities and expenses supporting those
activities, which includes share-based compensation expense. Drug development and
commercialization is very capital intensive. Until we receive approval from the FDA and other
regulatory authorities for our drug candidates, we cannot sell our drugs and will not have product
revenues. Therefore, for the foreseeable future, we will have to fund all of our operations and
capital expenditures from the net proceeds of any equity or debt offerings, cash on hand, licensing
fees and grants. Over the next 12 months, we expect to spend a minimum of approximately
$12 million on preclinical and clinical development for our products under development. Based on
our current plans and capital resources, we believe that our cash and cash equivalents will be
sufficient to enable us to meet our minimum planned operating needs for approximately the next 24
months. However, changes may occur that could consume our existing capital at a faster rate than
projected, including, among others, changes in the progress of our research and development
efforts, the cost and timing of regulatory approvals and the costs of protecting our intellectual
property rights. We may seek additional financing to implement and fund product development,
preclinical studies and clinical trials for the drugs in our pipeline, as well as additional drug
candidates and other research and development projects. If we are unable to secure additional
financing in the future on acceptable terms, or at all, we may be unable to commence or complete
planned preclinical and clinical trials or obtain approval of our drug candidates from the FDA and
other regulatory authorities. In addition, we may be forced to reduce or discontinue product
development or product licensing, reduce or forego sales and marketing efforts and other
commercialization activities or forego attractive business opportunities in order to improve our
liquidity and to enable us to continue operations which would have a material adverse effect on our
business and results of operations. Any additional sources of financing will likely involve the
issuance of our equity securities, which will have a dilutive effect on our shareholders.
Clinical trials are very expensive, time-consuming and difficult to design and implement and may
result in unforeseen costs which may have a material adverse effect on our business and results of
operations.
Human clinical trials are very expensive and difficult to design and implement, in part because
they are subject to rigorous regulatory requirements. The clinical trial process is also
time-consuming. Our drug candidates are in early stages of preclinical studies or clinical trials.
We estimate that we will be able to complete our current phase III clinical trial of prGCD and
file an NDA by the end of the second half of 2009. Other clinical trials of prGCD, will conclude
somewhat after, and any of our other potential drug candidates will take at least several years to
complete. Preliminary and initial results from a clinical trial do not necessarily predict final
results, and failure can occur at any stage of the trials. We may encounter problems that cause us
to abandon or repeat preclinical studies or clinical trials. Companies in the pharmaceutical and
biotechnology industries have suffered significant setbacks in advanced clinical trials, even after
obtaining promising results in earlier trials. Data obtained from tests are susceptible to varying
interpretations which may delay, limit or prevent regulatory approval. Failure or delay in the
commencement or completion of our clinical trials may be caused by several factors, including:
22
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unforeseen safety issues; |
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determination of dosing issues; |
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lack of effectiveness during clinical trials; |
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slower than expected rates of patient recruitment; |
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inability to monitor patients adequately during or after treatment; |
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inability or unwillingness of medical investigators and institutional review boards to
follow our clinical protocols; and |
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lack of sufficient funding to finance the clinical trials. |
Any failure or delay in commencement or completion of any clinical trials may have a material
adverse effect on our business and results of operations. In addition, we or the FDA or other
regulatory authorities may suspend our clinical trials at any time if it appears that we are
exposing participants to unacceptable safety or health risks or if the FDA or such other regulatory
authorities, as applicable, find deficiencies in our IND submissions or the conduct of these
trials. Any suspensions of our clinical trials may have a material adverse effect on our business
and results of operations.
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, 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 at that time, in the aggregate, 65,094,232 shares
of our common stock and options and warrants to purchase 3,628,826
23
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, 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 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 September
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 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 & Co., Inc.) 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 deposits. 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
None.
24
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 |
|
Article of Amendment to
Articles of Incorporation
dated June 9, 2006 |
|
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 |
|
Article of Amendment to
Articles of Incorporation
dated December 13, 2006 |
|
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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|
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3.4 |
|
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 |
|
Incorporated by
reference to the
Companys Quarterly
Report on Form 10-Q
filed on August 8,
2008, SEC File No.
001-33357 |
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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 |
25
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: March 6, 2009 |
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By:
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/s/ David Aviezer |
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David Aviezer, Ph.D. |
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President and Chief Executive Officer |
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(Principal Executive Officer) |
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Date: March 6, 2009 |
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By:
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/s/ Yossi Maimon |
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Yossi Maimon |
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Chief Financial Officer, Treasurer and Secretary |
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(Principal Financial and Accounting Officer) |
26