e424b5
The
information in this preliminary prospectus supplement is not
complete and may be changed. The preliminary prospectus
supplement and the accompanying prospectus are not an offer to
sell these securities and are not soliciting an offer to buy
these securities in any jurisdiction where the offer or sale is
not permitted
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Filed
Pursuant to Rule 424(b)(5)
Registration
No. 333-171615
SUBJECT TO COMPLETION, DATED
MARCH 17, 2011
PRELIMINARY PROSPECTUS SUPPLEMENT
(To Prospectus Dated January 13, 2011)
Shares
Common Stock
We are
selling shares
of our common stock.
We have granted the underwriters a
30-day
option to purchase up to additional
shares of our common stock to cover over-allotments.
Our common stock is listed on the NYSE Amex under the symbol
PLX and on the Tel Aviv Stock Exchange under the
trading symbol PLX. On March 16, 2011, the last
reported sale price of our common stock was $6.21 per share on
the NYSE Amex and NIS 22.66 per share on the Tel Aviv Stock
Exchange.
Investing in our common stock involves risks. See Risk
Factors beginning on
page S-6
of this prospectus supplement.
Neither the Securities and Exchange Commission, the Israeli
Securities Authority nor any state securities commission has
approved or disapproved of these securities or determined if
prospectus supplement or the accompanying prospectus is truthful
or complete. Any representation to the contrary is a criminal
offense.
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Underwriting Discount
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Proceeds to Protalix BioTherapeutics (before expenses)
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The underwriters expect to deliver the shares to purchasers on
or about March , 2011 through the book-entry
facilities of The Depository Trust Company.
Joint Book-Running Managers
March , 2011
You should rely only on the information contained in or
incorporated by reference in this prospectus supplement and the
accompanying prospectus. We have not authorized anyone to
provide you with different information. If anyone provides you
with different or inconsistent information, you should not rely
on it. We are not, and the underwriters are not, making an offer
to sell these securities in any state or jurisdiction where the
offer or sale is not permitted. You should not assume that the
information contained in this prospectus supplement or the
accompanying prospectus is accurate as of any date other than
the date on the front of this prospectus supplement or the
accompanying prospectus. Persons outside the United States who
come into possession of this prospectus supplement must inform
themselves about, and observe, any restrictions relating to the
offering of the common stock and the distribution of this
prospectus supplement outside the United States.
TABLE OF
CONTENTS
Prospectus
Supplement
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S-ii
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S-1
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S-5
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S-6
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S-10
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S-13
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S-15
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S-25
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S-25
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S-25
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S-26
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Prospectus
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Cautionary Statement Regarding Forward-Looking Statements
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About This Prospectus
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Our Business
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Risk Factors
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Use of Proceeds
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Dilution
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Securities We May Offer
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Description of Common Stock
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Plan of Distribution
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Where You Can Find More Information
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Incorporation of Certain Documents by Reference
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Legal Matters
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Experts
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S-i
ABOUT
THIS PROSPECTUS SUPPLEMENT
This prospectus supplement is a supplement to the accompanying
prospectus dated January 13, 2011 that is also a part of
this document. This prospectus supplement and the accompanying
prospectus are part of a registration statement that we filed
with the Securities and Exchange Commission, or the SEC, using a
shelf registration process. Under the shelf
registration process, from time to time, we may sell any of the
securities described in the accompanying prospectus in one or
more offerings. In this prospectus supplement, we provide you
with specific information about this offering. This prospectus
supplement, the accompanying prospectus and the documents
incorporated by reference herein and therein include important
information about us, our common stock and other information you
should know before investing in our common stock. This
prospectus supplement also adds, updates and changes information
contained in the accompanying prospectus. To the extent that any
statement that we make in this prospectus supplement is
inconsistent with the statements made in the accompanying
prospectus or in any document incorporated by reference that was
filed with the SEC before the date of this prospectus
supplement, the statements made in the accompanying prospectus,
or such an earlier filing, as applicable, are deemed modified or
superseded by the statements made in this prospectus supplement.
You should read both this prospectus supplement and the
accompanying prospectus as well as the additional information
described in this prospectus supplement under the headings
Where You Can Find More Information on
page S-25
and Incorporation of Certain Documents by Reference
on
page S-26
before investing in our common stock.
For purposes of this prospectus supplement and the accompanying
prospectus, references to the terms Protalix,
we, us and our refer to Protalix
BioTherapeutics, Inc. and its consolidated subsidiaries, unless
the context otherwise requires.
All references in this prospectus supplement to $,
U.S. Dollars and dollars are to
United States dollars.
This prospectus supplement, the accompanying prospectus and the
information incorporated by reference herein and therein include
trademarks, service marks and trade names owned by us or other
companies. All trademarks, service marks and trade names
included or incorporated by reference into this prospectus
supplement or the accompanying prospectus are the property of
their respective owners.
S-ii
PROSPECTUS
SUPPLEMENT SUMMARY
The following summary highlights certain information
contained elsewhere in this prospectus supplement, the
accompanying prospectus, any free writing prospectus that we
have authorized to use and the documents incorporated by
reference herein and in the accompanying prospectus. This
summary does not contain all the information you will need in
making your investment decision. You should carefully read this
entire prospectus supplement, the accompanying prospectus, any
free writing prospectus that we have authorized to use and the
documents incorporated by reference herein and in the
accompanying prospectus. You should pay special attention to the
Risk Factors section of this prospectus supplement
and the financial statements and other information incorporated
by reference herein and in the accompanying prospectus
supplement.
Our
Business
We are a biopharmaceutical company focused on the development
and commercialization of recombinant therapeutic proteins based
on our proprietary
ProCellExtm
protein expression system, or ProCellEx. Using our ProCellEx
system, we are developing a pipeline of proprietary and
biosimilar or generic versions of 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. 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 primarily 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.
Taliglucerase alfa, our proprietary, lead product candidate, is
a recombinant form of glucocerebrosidase (GCD) that we are
developing for the treatment of Gaucher disease patients using
our ProCellEx protein expression system. Gaucher disease is a
rare and serious lysosomal storage disorder with severe and
debilitating symptoms. Patients of Gaucher disease suffer from
mutations in or deficiencies of GCD, which is an enzyme that is
naturally found in human cells. In July 2007, we reached an
agreement with the U.S. Food and Drug Administration, or
the FDA, on the final design of our pivotal phase III
clinical trial of taliglucerase alfa through the FDAs
special protocol assessment process (SPA). We completed the
phase III clinical trial of taliglucerase alfa for the
treatment of Gaucher disease in September 2009 and, on
October 15, 2009, we announced positive top-line results
from the trial. We originally filed a New Drug Application (NDA)
for taliglucerase alfa on December 9, 2009, and in January
2010 the FDA requested additional data regarding the chemistry,
manufacturing and controls (CMC) section of the NDA. We
provided the requested data to the FDA in April 2010, and in
July 2010 we received notification from the FDA that it had
accepted the filing of our NDA and assigned a Prescription Drug
User Fee Act (PDUFA) date of February 25, 2011 to
taliglucerase alfa for the treatment of Gaucher disease. In
addition to the NDA, in November 2010 we submitted a marketing
application to the Israeli Ministry of Health, or the Israeli
MOH, and a Marketing Authorization Application (MAA) to each of
the European Medicines Agency, or the EMEA, and ANVISA, the
National Sanitary Vigilance Agency, an agency of the Brazilian
Ministry of Health, or the ANVISA, for taliglucerase alfa for
the treatment of Gaucher disease.
On February 25, 2011, we announced that the FDA issued a
Complete Response Letter, or a CRL, regarding our NDA for
taliglucerase alfa for the treatment of Gaucher disease. A CRL
is issued by the FDAs Center for Drug Evaluation and
Research when the review of a file is completed and questions
remain that preclude the approval of the NDA in its current
form. The main questions raised by the FDA regarding the NDA
relate to the clinical and CMC sections. In the clinical section
of the CRL, the FDA requested additional data from the ongoing
switchover trial and the long-term extension trial. At the time
the NDA was submitted, full data from these trials was not
available. In the CMC section of the CRL, the FDA requested
information regarding testing specifications and assay
validation. The FDA did not request additional clinical studies
in the CRL. The marketing application submitted to the Israeli
MOH and the MAAs submitted to each of the EMEA and ANVISA
include certain data now being requested by the FDA in the CRL
as those applications were
S-1
submitted approximately a year after we filed our NDA and after
we had collected additional data from our ongoing trials. We are
working with Pfizer Inc., or Pfizer, our commercialization
partner, to respond to the CRL. We have already begun preparing
our response to the CRL, with Pfizers cooperation, and
intend to request a meeting with the FDA as soon as possible to
clarify the path to regulatory approval.
In February 2010, the Israeli MOH completed a successful good
manufacturing practices (GMP) audit of our manufacturing
facilities in Carmiel, Israel. The audit was performed as part
of the Israeli MOHs evaluation of our manufacturing
process for taliglucerase alfa. On February 20, 2011, we
received a letter from the FDA notifying us that the FDA had
completed its review of the Establishment Inspection Report in
connection with the FDAs inspection of our facility in
Carmiel, Israel, and that the FDA had classified our facility as
acceptable.
In addition to our recently completed phase III clinical
trial, we initiated a double-blind, follow-on extension study as
part of the trial during the second quarter of 2008. We also
initiated a home care treatment program for patients enrolled in
the extension study and, in December 2008, we initiated a
nine-month, worldwide, multi-center, open-label, switch-over
clinical study evaluating the safety and efficacy of switching
Gaucher patients currently treated under the current standard of
care to treatment with taliglucerase alfa. Patients in these
trials are still being treated with taliglucerase alfa. The
current standard of care for Gaucher patients is enzyme
replacement therapy with Cerezyme, which is produced by Genzyme
Corporation and, until the recent approval of VPRIV by Shire plc
in February 2010, was the only approved enzyme replacement
therapy for Gaucher disease. Enzyme replacement therapy is a
medical treatment in which recombinant enzymes are infused into
patients in whom the enzyme is lacking or dysfunctional.
Taliglucerase alfa has an amino acid, glycan and
three-dimensional structure that is very similar to Cerezyme,
which is a mammalian cell expressed version of the same protein.
We believe taliglucerase alfa may prove more cost-effective than
the currently marketed alternatives due to the cost benefits of
expression through our ProCellEx protein expression system.
Although the FDA did not originally require the switch-over
study in the SPA as a prerequisite for approval of taliglucerase
alfa, the FDA has now requested data from the switchover trial
in the CRL. In December 2009, we filed a proposed pediatric
investigation plan to the Pediatric Committee of the EMEA which
was approved during the first quarter of 2010 and have since
initiated the study. In November 2010, we announced positive
preliminary data from the first 15 patients that completed
the switchover clinical study of taliglucerase alfa. Only
pediatric patient enrollment remains open for this study.
On November 30, 2009, Protalix Ltd., our wholly-owned
subsidiary, and Pfizer entered into an exclusive license and
supply agreement pursuant to which Pfizer was granted an
exclusive, worldwide license to develop and commercialize
taliglucerase alfa. Under the terms and conditions of the Pfizer
agreement, Protalix Ltd. retained the right to commercialize
taliglucerase alfa in Israel. In connection with the execution
of the Pfizer agreement, Pfizer made an upfront payment to
Protalix Ltd. of $60.0 million in connection with the
execution of the agreement and subsequently paid Protalix Ltd.
an additional $5.0 million upon its filing of a proposed
pediatric investigation plan to the Pediatric Committee of the
EMEA. Protalix Ltd. is also eligible to receive potential
milestone payments totaling $50.0 million for the
successful achievement of other regulatory milestones. Pfizer
and Protalix Ltd. will also share future revenues and expenses
for the development and commercialization of taliglucerase alfa
on a 60% and 40% basis, respectively, and have also agreed to a
specific allocation of the responsibilities for the continued
development efforts for taliglucerase alfa.
In July 2009, following a request by the FDA, we submitted a
treatment protocol to the FDA in order to address an expected
shortage of the current enzyme replacement therapy approved for
Gaucher disease. The treatment protocol was approved by the FDA
in August 2009, and we are continuing to treat patients in the
United States under this protocol. In September 2009, the
FDAs Office of Orphan Product Development granted
taliglucerase alfa Orphan Drug Status. In January 2010, the
Committee for Orphan Medicinal Products (COMP) of the EMEA,
after reviewing all relevant clinical data, recommended that the
European Commission grant Orphan Drug designation to
taliglucerase alfa for the treatment of Gaucher disease. The
Orphan Drug designation in the United States for taliglucerase
alfa for the treatment of Gaucher disease provides special
status to taliglucerase alfa provided that it meets certain
criteria. As a result of the Orphan Drug designation, we are
qualified for the tax credit and marketing incentives of the
Orphan Drug Act of 1983. A marketing application for a
prescription drug product that has been designated as a drug for
a rare disease or condition is
S-2
not subject to a prescription drug user fee unless the
application includes an indication for other than a rare disease
or condition.
On July 13, 2010, we announced that the French regulatory
authority had granted an Autorisation Temporaire
dUtilisation (ATU), or Temporary Authorization for Use,
for taliglucerase alfa for the treatment of Gaucher disease. An
ATU is the regulatory mechanism used by the French Health
Products and Safety Agency to make non-approved drugs available
to patients in France when a genuine public health need exists.
This ATU allows patients with Gaucher disease in France to
receive treatment with taliglucerase alfa before marketing
authorization for the product is granted in the European Union.
Payment for taliglucerase alfa has been secured through
government allocations to hospitals. Recently, the French
Ministry of Health announced again that there is a shortage of
enzyme replacement therapy for Gaucher disease, and we are
currently providing taliglucerase alfa to patients under the
ATU. In addition to the United States, France and Brazil,
taliglucerase alfa is also currently being provided to Gaucher
disease patients under special access agreements or Named
Patient provisions in the rest of the world.
On August 10, 2010, Pfizer entered into a $30 million
short-term supply agreement with the Ministry of Health of
Brazil pursuant to which Protalix and Pfizer have provided
taliglucerase alfa to the Ministry of Health of Brazil for the
treatment of patients with Gaucher disease. Revenue generated
from the Ministry of Health of Brazil will be recorded by
Pfizer, and we are entitled to our share of the revenue in
accordance with the terms and conditions of the Pfizer
agreement. In addition, we and the Ministry of Health of Brazil
are in discussions relating to a possible long-term supply
agreement that contemplates, among other matters, providing
certain components of our manufacturing technology to the
Ministry of Health of Brazil for implementation by it in Brazil.
We are currently unable to assess whether these discussions will
result in an agreement and we can make no assurance that we will
be able to enter into such an agreement on favorable terms, if
at all. In any event, we do not expect to enter into a long-term
supply agreement with the Ministry of Health of Brazil until we
receive marketing approval of taliglucerase alfa from the FDA or
ANVISA, if at all.
In addition to taliglucerase alfa, we are developing an
innovative product pipeline using our ProCellEx protein
expression system. Our product pipeline currently includes,
among other candidates, (1) PRX-102, a therapeutic protein
candidate for the treatment of Fabry disease, a rare, genetic
lysosomal disorder in humans, (2) PRX-105, a plant cell
expressed pegylated recombinant acetylcholinesterase product
candidate for biodefense and other indications,
(3) pr-antiTNF, a plant cell expressed recombinant fusion
protein made from the soluble form of the human TNF receptor
(TNFR) and an antibody portion, which is being developed as a
treatment of certain immune diseases such as rheumatoid
arthritis, juvenile idiopathic arthritis, ankylosing,
spondylitis, psoriatic arthritis and plaque psoriasis,
(4) an orally administrated glucocerebrosidase enzyme for
treating Gaucher patients utilizing the oral delivery of the
recombinant enzyme produced within carrot cells and
(5) additional undisclosed therapeutic proteins, all of
which are currently being evaluated in animal studies. In March
2010, we initiated a preliminary phase I clinical trial of
PRX-105 which we completed in June 2010. We are currently
preparing for further efficacy trials of this product candidate
in larger animals. In our preclinical studies we utilized an
analogue to nerve gas. However, we anticipate that we will use
live nerve gas rather than an analogue in the proposed
additional efficacy trials in animals. In December 2010, we held
a pre-investigational new drug, or IND, meeting with the FDA
with respect to PRX-102. We expect to submit an IND to the FDA
within the next 12 months in connection with an anticipated
phase I/II study of PRX-102 and to initiate the trial once the
IND is approved, if at all. We have also scheduled a pre-IND
meeting with the FDA regarding our antiTNF program for March
2011.
Except for the license we have granted to Pfizer, 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
taliglucerase alfa in Israel and our other products, if
approved, in North America, the European Union and in other
significant markets, including Israel. In addition, we plan to
continue evaluating potential strategic marketing partnerships.
S-3
Our
Corporate Information
We are incorporated under the laws of the State of Florida. Our
principal executive offices are located at 2 Snunit Street,
Science Park, POB 455, Carmiel, 20100 Israel, and our telephone
number is
+972 (4) 988-9488.
Our website is www.protalix.com. The information on or
accessible through our website does not constitute part of this
prospectus supplement or the accompanying prospectus and should
not be relied upon in connection with making any investment in
our securities.
S-4
The
Offering
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Issuer |
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Protalix BioTherapeutics, Inc. |
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Common Stock Offered by Us |
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shares
(or shares if the
underwriters exercise their over-allotment option in full). |
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Common Stock to be Outstanding After This Offering |
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shares
(or shares if the
underwriters exercise their over-allotment option in full). |
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Use of Proceeds |
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We expect the net proceeds from this offering to us will be
approximately $ million (or
$ million if the underwriters
exercise their option to purchase additional shares in full),
after deducting the underwriting discount and estimated offering
expenses payable by us. We currently expect to use the net
proceeds primarily to fund clinical trials for our product
candidates, to fund our research and development activities, to
enhance our manufacturing capacity and for working capital and
general corporate purposes. See Use of Proceeds. |
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Risk Factors |
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Before investing in our common stock, you should carefully read
and consider the Risk Factors beginning on
page S-6
of this prospectus supplement. |
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Trading Symbol for Our Common Stock |
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Our common stock is listed on each of the NYSE Amex and the Tel
Aviv Stock Exchange under the symbol PLX. |
The number of shares of common stock to be outstanding after
this offering is based on 81,248,472 shares outstanding as
of December 31, 2010, and excludes as of such date:
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7,806,671 shares of common stock issuable upon the exercise
of outstanding stock options as of December 31, 2010, at a
weighted average exercise price of $3.73 per share; and
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an aggregate of 3,064 shares of common stock reserved for
future issuance under our 2006 Stock Incentive Plan.
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Unless otherwise indicated, this prospectus supplement assumes
no exercise by the underwriters of their over-allotment option.
S-5
RISK
FACTORS
Investing in our securities involves a high degree of risk.
You should carefully consider the specific risks described below
and the risks described in our Annual Report on
Form 10-K
for the fiscal year ended December 31, 2010, which are
incorporated by reference in this prospectus supplement and the
accompanying prospectus in their entirety, together with the
other information in this prospectus supplement, the
accompanying prospectus and the information and documents
incorporated by reference, before making an investment decision.
See the section of this prospectus supplement entitled
Where You Can Find More Information. Any of the
risks we describe below or in the information incorporated
herein by reference could cause our business, financial
condition and results of operations to suffer. The market price
of our common stock could decline if one or more of these risks
and uncertainties develop into actual events. You could lose all
or part of your investment.
We may
not obtain the necessary U.S. or worldwide regulatory approvals
to commercialize our drug candidates in a timely manner, if at
all, which would have a material adverse effect on our business,
financial condition and results of operations.
We will need FDA approval to commercialize our drug candidates
in the United States and approvals from foreign regulators to
commercialize our drug candidates elsewhere. In order to obtain
FDA approval of any of our drug candidates, we must submit to
the FDA an NDA or a Biologic License Application (BLA)
demonstrating that the drug candidate is safe for humans and
effective for its intended use. This demonstration requires
significant research and animal tests, which are referred to as
preclinical studies, as well as human tests, which are referred
to as clinical trials. In the European Union, we must submit an
MAA to the EMEA. Satisfaction of the FDAs and foreign
regulatory authorities regulatory requirements typically
takes many years, and depends upon the type, complexity and
novelty of the drug candidate and requires substantial resources
for research, development and testing. In December 2009, we
completed the filing of an NDA for taliglucerase alfa for the
treatment of Gaucher disease and received a PDUFA date of
February 25, 2011, and in November 2010, we submitted a
marketing application to the Israeli MOH and an MAA to each of
the EMEA and ANVISA for taliglucerase alfa.
In February 2011, we received a CRL from the FDA regarding our
NDA for taliglucerase alfa for the treatment of Gaucher disease.
The main questions raised by the FDA regarding the NDA relate to
clinical and chemistry, manufacturing and controls (CMC). In the
clinical section of the CRL, the FDA requested additional data
from the ongoing switchover trial and the long-term extension
trial relating to taliglucerase alfa. At the time the NDA was
submitted, full data from these trials was not available. In the
CMC section of the CRL, the FDA requested information regarding
testing specifications and assay validation. The FDA did not
request additional clinical studies in the CRL. We intend to
request a meeting with the FDA as soon as possible to clarify
the path to regulatory approval. Until we have further
clarifications from the FDA regarding the CRL, we can not
provide any details regarding our response to the CRL. In
addition, there can be no assurance that the FDA will not make
any additional request regarding our NDA. In the past, the FDA
has made additional requests to other applicants after the
delivery of a CRL. Any additional requests from the FDA relating
to the NDA may delay or preclude our response to the CRL. Even
if we comply with all of the FDAs requests in the CRL or
otherwise, if any, the FDA may ultimately reject the NDA, or
fail to approve the NDA in a timely manner, which would have a
material adverse effect on our business, financial condition and
results of operations.
Under FDA regulations, there are two forms of resubmission of an
NDA after receipt of a CRL. A class 1 resubmission of an
NDA following receipt of a CRL starts a new two-month review
cycle. A class 2 resubmission of an NDA starts a new
six-month review cycle. At this time, we do not know how the FDA
will classify resubmission we will be required to make in
responding to the CRL. If it is classified as a class 2
resubmission, the FDAs review of the resubmission may
result in a longer delay in the approval of taliglucerase alfa,
if at all, which would have a material adverse effect on our
business, financial condition and results of operations.
S-6
Our research and clinical efforts may not result in drugs that
the FDA or foreign regulatory authorities consider safe for
humans and effective for indicated uses, which would have a
material adverse effect on our business, financial condition and
results of operations. After clinical trials are completed for
any drug candidate, if at all, the FDA and foreign regulatory
authorities have substantial discretion in the drug approval
process of the drug candidate in their respective jurisdictions
and may require us to conduct additional clinical testing or to
perform post-marketing studies which would cause us to incur
additional costs. Incurring such costs could have a material
adverse effect on our business, financial condition and results
of operations.
The approval process for any drug candidate may also be delayed
by changes in government regulation, future legislation or
administrative action or changes in policy of the FDA and
comparable foreign authorities that occur prior to or during
their respective regulatory reviews of such drug candidate.
Delays in obtaining regulatory approvals with respect to any
drug candidate may:
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delay commercialization of, and our ability to derive product
revenues from, such drug candidate;
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delay the regulatory-related milestone payments we anticipate
receiving from Pfizer;
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require us to perform costly procedures with respect to such
drug candidate; or
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otherwise diminish any competitive advantages that we may have
with respect to such drug candidate.
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Even if we comply with all the requests of the FDA and
comparable foreign authorities, the authorities may ultimately
reject the NDA or other filing or submission we filed for
taliglucerase alfa or one or more of the NDAs or other filing or
submission we file in the future, if any, or we might not obtain
regulatory clearance in a timely manner for taliglucerase alfa
or any of our other product candidates. Companies in the
pharmaceutical and biotechnology industries have suffered
significant setbacks in advanced or late-stage clinical trials,
even after obtaining promising earlier trial results or in
preliminary findings or other comparable authorities for such
clinical trials. Further, even if favorable testing data is
generated by the clinical trials of a drug product, the FDA,
EMEA or other regulatory authority may not accept or approve an
NDA, MAA or other comparable submission, as applicable, filed by
a pharmaceutical or biotechnology company for the drug product.
Failure to obtain approval of the FDA or comparable foreign
authorities of any of our drug candidates in a timely manner, if
at all, will severely undermine our business, financial
condition and results of operation by reducing our potential
marketable products and our ability to generate corresponding
product revenues.
We
currently depend heavily on the success of taliglucerase alfa,
our lead product candidate. Any failure to commercialize
taliglucerase alfa, or the experience of significant delays in
doing so, will have a material adverse effect on our business,
financial condition and results of operations.
We have invested a significant portion of our efforts and
financial resources in the development of taliglucerase alfa.
Our ability to generate product revenue depends heavily on the
successful development and commercialization of taliglucerase
alfa. In November 2009, we granted to Pfizer an exclusive
worldwide license to develop and commercialize taliglucerase
alfa, except in Israel. We retained such rights in Israel. The
successful commercialization of taliglucerase alfa will depend
on several factors, including the following:
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promptly and successfully completing our response to the CRL;
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obtaining marketing approvals from the FDA and other foreign
regulatory authorities;
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successful completion of our ongoing studies of taliglucerase
alfa;
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maintaining the cGMP compliance of our manufacturing facility or
establishing manufacturing arrangements with third parties;
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the successful audit of our facilities by the FDA, the Israeli
MOH and other foreign regulatory authorities;
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Pfizers efforts under the Pfizer agreement;
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our development of a successful sales and marketing organization
for taliglucerase in Israel;
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S-7
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the availability of reimbursement to patients from healthcare
payors for our drug products, if approved;
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a continued acceptable safety and efficacy profile of our
product candidates following approval; and
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other risks described in these risk factors and those set forth
in our Annual Report on
Form 10-K
for the year ended December 31, 2010.
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Any failure to commercialize taliglucerase alfa or the
experience of significant delays in doing so will have a
material adverse effect on our business, financial condition and
results of operations.
A
substantial number of shares may be sold in the market following
this offering, which may depress the market price for our common
stock.
Sales of a substantial number of shares of our common stock in
the public market following this offering, either on the NYSE
Amex or the Tel Aviv Stock Exchange, could cause the market
price of our common stock to decline. Upon completion of this
offering, based on our shares outstanding as of
December 31, 2010, we will have outstanding an aggregate
of shares of common stock, assuming
no exercise of outstanding options. A substantial majority of
the outstanding shares of our common stock are, and all of the
shares sold in this offering upon issuance will be, freely
tradable without restriction or further registration under the
Securities Act of 1933, as amended, or the Securities Act,
unless these shares are owned or purchased by
affiliates as that term is defined in Rule 144
under the Securities Act. In addition, we have also registered
all common stock that we may issue under our 2006 Stock
Incentive Plan, and as of December 31, 2010, a total of
7,806,671 shares of our common stock are issuable upon
exercise of outstanding options granted by us, at a weighted
average exercise price of $3.73 per share, and a total of
3,064 shares of common stock remain available for future
for issuance under such plan. As a result, these shares can be
freely sold in the public market upon issuance, subject to
restrictions under the securities laws. In addition, four of our
executive officers have entered into trading plans established
under
Rule 10b5-1
under the Securities Act that allow for sales of approximately
1.3 million shares upon receipt of FDA approval of
taliglucerase alfa, if at all.
We may
use the net proceeds of this offering in ways with which you may
disagree.
We intend to use the net proceeds of this offering to raise
capital to fund clinical trials for our product candidates, to
fund our research and development activities, to enhance our
manufacturing capacity and for working capital and general
corporate purposes. As of the date of this prospectus
supplement, we cannot specify with certainty all of the
particular uses of the proceeds from this offering. Accordingly,
we will have significant discretion in the use of the net
proceeds of this offering. It is possible that we may allocate
the proceeds differently than investors in this offering desire
or that we will fail to maximize our return on these proceeds.
We may, subsequent to this offering, modify our intended use of
the offering proceeds to pursue strategic opportunities that may
arise, such as potential acquisition opportunities. You will be
relying on the judgment of our management with regard to the use
of the net proceeds of this offering, and you will not have the
opportunity, as part of your investment decision, to assess
whether the proceeds are being used appropriately. Our failure
to apply the net proceeds of this offering effectively could
have a material adverse effect on our business or the
commercialization of taliglucerase alfa, if approved by the FDA,
and cause the price of our common stock to decline.
You
will experience immediate dilution in the net tangible book
value of the shares of our common stock you purchase as a result
of this offering.
If you purchase shares of our common stock in this offering, you
will pay more for your shares than the net tangible book value
per share of our common stock as of December 31, 2010. As a
result, the value of your investment based on the net tangible
book value per share of our common stock will be less than what
it would have been had you and all of the existing stockholders
paid the same amount per share of common stock as you will pay
in this offering. Since the price per share of our common stock
being offered is substantially higher than the net tangible book
value per share of our common stock, you will suffer substantial
dilution in the net tangible book value of the common stock you
purchase in this offering. The
S-8
exercise of outstanding options into common stock and future
issuances by us of equity or convertible debt may result in
further dilution to your investment in our common stock. See
Dilution.
You
may experience future dilution as a result of future equity
offerings or other equity issuances.
In order to raise additional capital, we may in the future offer
and issue additional shares of our common stock or other
securities convertible into or exchangeable for our common
stock. We cannot assure you that we will be able to sell shares
or other securities in any other offering at a price per share
that is equal to or greater than the price per share paid by
investors in this offering, and investors purchasing shares or
other securities in the future could have rights superior to
existing stockholders. The price per share at which we sell
additional shares of our common stock or other securities
convertible into or exchangeable for our common stock in future
transactions may be higher or lower than the price per share in
this offering. As of December 31, 2010, an aggregate of
3,064 shares of common stock were reserved and available
for future grant under our 2006 Stock Incentive Plan. Also as of
such date, options to purchase 7,806,671 shares of our
common stock were outstanding. You will incur dilution upon the
grant of any shares pursuant to such plan, upon vesting of any
stock awards under any such plan, or upon exercise of any such
outstanding options.
S-9
CAUTIONARY
STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
The statements set forth and incorporated by reference in this
prospectus supplement and the accompanying prospectus, which are
not historical, constitute forward looking
statements within the meaning of Section 27A of the
Securities Act and Section 21E of the Securities Exchange
Act of 1934, as amended, or the Exchange Act, including
statements regarding the expectations, beliefs, intentions or
strategies for the future. When used in this prospectus
supplement and the accompanying prospectus, or in any document
incorporated by reference in this prospectus supplement or the
accompanying prospectus, the terms anticipate,
believe, estimate, expect,
intend, could, may,
plan, potential, predict,
project, should, will,
would and words or phrases of similar import, as
they relate to us, or our subsidiaries or our management, are
intended to identify forward-looking statements, although not
all forward-looking statements contain these words. We intend
that all forward-looking statements be subject to the
safe-harbor provisions of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements include, but are
not limited to, statements about our expectations as to
regulatory approvals, submissions of regulatory filings, market
opportunity for our product candidates, goals as to product
candidate development and timeliness of our clinical trials.
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. Example of the risks and
uncertainties include, but are not limited to, the following:
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delays in our response to the CRL we received from the FDA
relating to our NDA for taliglucerase alfa;
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delays in the FDAs review of any response to the CRL, if
any;
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delays in the approval or the potential rejection of any
applications we file with the FDA or other regulatory
authorities, including the NDA we have filed with the FDA, the
marketing application we submitted to the Israeli MOH and the
MAA we have submitted to each of the EMEA and ANVISA for
taliglucerase alfa;
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the inherent risks and uncertainties in developing the types of
drug platforms and products we are developing;
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delays in our preparation and filing of applications for
regulatory approval in the United States, the European Union,
Israel, Brazil and elsewhere;
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any lack of progress of our research and development (including
the results of our clinical trials);
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our ability to establish and maintain strategic license,
collaboration and distribution arrangements and to manage our
relationships with Pfizer, Teva Ltd. or with any other
collaborator, distributor or partner;
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our ability to obtain 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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risks relating to biogeneric legislation and/or healthcare
reform in the United States or elsewhere;
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our ability to obtain additional financing required to fund our
research programs and the expansion of our manufacturing
capabilities;
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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 enter into supply arrangements with the Ministry
of Health of Brazil or other parties and to supply drug product
pursuant to such arrangements;
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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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S-10
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the availability of reimbursement to patients from health care
payors for any of our product candidates, 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; and
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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
subsidiaries, our manufacturing facilities and our customers,
suppliers, distributors, collaborative partners, licensees and
clinical trial sites.
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In February 2011, we received a CRL from the FDA regarding our
NDA for taliglucerase alfa for the treatment of Gaucher disease.
The main questions raised by the FDA regarding the NDA relate to
the clinical and CMC sections. In the clinical section of the
CRL, the FDA requested additional data from each of the
switchover trial and the long-term extension trial. In the CMC
section of the CRL, the FDA requested information regarding
testing specifications and assay validation. The FDA did not
request additional clinical studies in the CRL. Until we have
further clarifications from the FDA regarding the CRL, there can
be no assurance that the FDA will not make any additional
request regarding our NDA. In the past, the FDA has made
additional requests to other applicants after the delivery of a
CRL. Any additional requests from the FDA relating to the NDA
may delay or preclude our response to the CRL. Even if we comply
with all of the FDAs requests in the CRL, or otherwise if
any, the FDA may ultimately reject the NDA, or fail to approve
the NDA in a timely manner, which would have a material adverse
effect on our business, financial condition and results of
operations. In addition, if we are required to make a
class 2 resubmission in response to the CRL, the FDAs
review of the resubmission may result in a longer delay in the
approval of taliglucerase alfa, if at all, which would have a
material adverse effect on our business, financial condition and
results of operations. Our efforts to respond to the CRL, and
any development with the FDA with respect to our response, may
result in changes to our current expectations as reflected in
our forward-looking statements.
These forward-looking statements reflect our current views with
respect to future events and are based on assumptions and
subject to risks and uncertainties. Given these uncertainties,
you should not place undue reliance on these forward-looking
statements. These and other risks and uncertainties are detailed
under the heading Risk Factors beginning on
page S-6
of this prospectus supplement, in our Annual Report on
Form 10-K
for the year ended December 31, 2010, Section 1A,
under the heading Risk Factors, and described from
time to time in our future reports to be filed with the SEC.
Any or all of our 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 or revise, nor do we have a
policy of updating or revising, 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.
S-11
USE OF
PROCEEDS
We estimate that the net proceeds we will receive from this
offering will be approximately
$ million (or approximately
$ million if the underwriters
exercise in full their option to
purchase shares
of common stock), after deducting the underwriting discount and
estimated offering expenses payable by us.
We currently expect to use the net proceeds of this offering to
fund clinical trials for our product candidates; to fund our
research and development activities; to enhance our
manufacturing capacity; and for working capital and general
corporate purposes.
The foregoing information is based on our current business plan.
As of the date of this prospectus supplement, we cannot specify
with certainty all of the particular uses of the net proceeds of
this offering. We may find it necessary to shift funds reserved
for one category of uses to another purpose. For example, we
may, subsequent to this offering, pursue strategic opportunities
that may arise, such as potential acquisition opportunities,
although we have no current plans, commitments or agreements to
do so as of the date of this prospectus supplement. We have
broad discretion and may find it necessary or advisable to
re-allocate portions of the net proceeds of this offering. The
amounts and timing of our actual expenditures will depend on
numerous factors, including the status of the FDAs, the
EMEAs and other regulatory authorities review of
taliglucerase alfa, our product development and
commercialization efforts, our sales and marketing activities,
the amount of cash used by our operations and our assessment of
the ability to add long-term shareholder value through potential
strategic opportunities. Investors will be relying on the
judgment of our management regarding the application of these
net proceeds. Pending these uses, we intend to invest the net
proceeds of the offering in short-term bank deposits or
marketable securities.
S-12
PRICE
RANGE OF COMMON STOCK
Our common stock began trading on the NYSE Amex on
March 12, 2007 under the symbol PLX. The
following table sets forth, for the periods indicated, the high
and low closing prices for our common stock, as reported by the
NYSE Amex for the periods indicated.
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Price Range
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High
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Low
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Annual:
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2010
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$
|
10.00
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$
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5.84
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2009
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$
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12.14
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$
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1.80
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2008
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$
|
3.70
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$
|
0.96
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Quarterly:
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First Quarter 2011 (through March 16)
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$
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10.46
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$
|
6.21
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Fourth Quarter 2010
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$
|
10.00
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$
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8.40
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Third Quarter 2010
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$
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9.00
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$
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5.99
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Second Quarter 2010
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$
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7.00
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$
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5.84
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First Quarter 2010
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$
|
7.70
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$
|
6.56
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Fourth Quarter 2009
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$
|
12.14
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|
$
|
6.62
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Third Quarter 2009
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|
$
|
8.31
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$
|
4.51
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Second Quarter 2009
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|
$
|
5.24
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|
$
|
2.10
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First Quarter 2009
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$
|
2.89
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$
|
1.80
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Fourth Quarter 2008
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|
$
|
2.17
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|
|
$
|
0.96
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Third Quarter 2008
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|
$
|
3.06
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|
|
$
|
2.08
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Second Quarter 2008
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|
$
|
3.70
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|
$
|
2.56
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First Quarter 2008
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|
$
|
3.59
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|
|
$
|
2.59
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Most Recent Six Months:
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March 2011 (through March 16)
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$
|
7.04
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$
|
6.21
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February 2011
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|
$
|
10.43
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|
|
$
|
7.05
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January 2011
|
|
$
|
10.46
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|
|
$
|
9.44
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December 2010
|
|
$
|
9.99
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|
|
$
|
8.67
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November 2010
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|
$
|
10.00
|
|
|
$
|
8.40
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October 2010
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$
|
9.96
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$
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8.85
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September 2010
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$
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9.00
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$
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7.68
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S-13
Our common stock began trading on the Tel Aviv Stock Exchange on
September 6, 2010 under the symbol PLX. The
following table sets forth, for the periods indicated, the high
and low closing prices for our common stock in Israeli New
Shekels (NIS) and U.S. dollars. U.S. dollar per share
of common stock amounts are calculated using the
U.S. dollar representative rate of exchange on the date to
which the high or low market price is applicable, as reported by
the Bank of Israel.
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Price Range (NIS)
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Price Range ($)
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High
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Low
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High
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|
Low
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Annual:
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|
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2010 (from September 6)
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NIS 36.14
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|
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NIS 30.95
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|
$
|
9.98
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|
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$
|
8.29
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Quarterly:
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|
|
|
|
|
|
|
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|
|
|
|
|
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First Quarter 2011 (through March 16)
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NIS 38.12
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|
|
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NIS 21.82
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$
|
10.43
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|
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$
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6.13
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Fourth Quarter 2010
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NIS 36.14
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|
|
|
NIS 31.04
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|
|
$
|
9.98
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|
|
$
|
8.50
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Third Quarter 2010 (from September 6)
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|
|
NIS 32.36
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|
|
|
NIS 30.95
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|
|
$
|
8.62
|
|
|
$
|
8.29
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Most Recent Six Months:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 2011 (through March 16)
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NIS 25.51
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|
|
|
NIS 21.82
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|
|
$
|
7.04
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|
|
$
|
6.13
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February 2011
|
|
|
NIS 38.12
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|
|
|
NIS 26.80
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|
|
$
|
10.37
|
|
|
$
|
7.40
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January 2011
|
|
|
NIS 37.31
|
|
|
|
NIS 33.10
|
|
|
$
|
10.43
|
|
|
$
|
8.99
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December 2010
|
|
|
NIS 35.80
|
|
|
|
NIS 31.88
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|
|
$
|
9.97
|
|
|
$
|
8.75
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|
November 2010
|
|
|
NIS 36.14
|
|
|
|
NIS 31.04
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|
|
$
|
9.98
|
|
|
$
|
8.50
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October 2010
|
|
|
NIS 35.78
|
|
|
|
NIS 32.58
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|
|
$
|
9.84
|
|
|
$
|
8.98
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September 2010 (from September 6)
|
|
|
NIS 32.36
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|
|
|
NIS 30.95
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|
|
$
|
8.62
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|
|
$
|
8.29
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S-14
CAPITALIZATION
The following table presents our capitalization as of
December 31, 2010:
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|
|
|
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on an actual basis; and
|
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on an as adjusted basis to reflect the sale
of shares
of common stock at the public offering price of $
per share, the receipt by us of net proceeds of approximately
$ million, after deducting the underwriting
discount and the estimated offering expenses payable by us.
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This table should be read in conjunction with our financial
statements and the notes thereto incorporated by reference
herein and the accompanying prospectus.
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2010
|
|
|
|
Actual
|
|
|
As Adjusted
|
|
|
|
(in thousands, except share data)
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable and accruals (trade and other)
|
|
$
|
14,340
|
|
|
$
|
|
|
Short-term deferred revenues
|
|
|
4,563
|
|
|
|
|
|
Long-term deferred revenues
|
|
|
55,486
|
|
|
|
|
|
Liability for employee rights upon retirement
|
|
|
1,663
|
|
|
|
|
|
Total liabilities
|
|
|
76,052
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders equity:
|
|
|
|
|
|
|
|
|
Common stock, par value $.001 per share; 150,000,000 authorized
shares, 81,248,472 issued and outstanding shares,
actual; issued
and outstanding shares, as adjusted
|
|
$
|
81
|
|
|
$
|
|
|
Additional paid-in capital
|
|
|
124,044
|
|
|
|
|
|
Accumulated deficit
|
|
|
(135,448
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total shareholders equity (capital deficiency)
|
|
|
(11,323
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total capitalization
|
|
$
|
64,729
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
The number of as adjusted shares of common stock in the above
table excludes, as of December 31, 2010:
|
|
|
|
|
7,806,671 shares of common stock issuable upon the exercise
of outstanding stock options as of December 31, 2010, at a
weighted average exercise price of $3.73 per share; and
|
|
|
|
an aggregate of 3,064 shares of common stock reserved for
future issuance under our 2006 Stock Incentive Plan.
|
S-15
DILUTION
If you invest in our common stock, your interest will be diluted
immediately to the extent of the difference between the public
offering price per share of our common stock and the as adjusted
net tangible book value per share of common stock after this
offering.
The net tangible book value (deficit) of our common stock as of
December 31, 2010 was approximately $(11.3) million,
or approximately $(0.14) per share. Net tangible book value per
share represents the amount of our total tangible assets less
total liabilities divided by the total number of shares of our
common stock outstanding.
Dilution per share to new investors represents the difference
between the amount per share paid by purchasers for our common
stock in this offering and the net tangible book value per share
of our common stock immediately following the completion of this
offering.
After giving effect to the sale of shares of common stock
offered by this prospectus supplement at the public offering
price of $ per share in connection
with this offering and after deducting the underwriting discount
and estimated offering expenses payable by us, our as adjusted
net tangible book value as of December 31, 2010 would have
been approximately $ million,
or approximately $ per share. This
represents an immediate increase in net tangible book value of
approximately $ per share to our
existing stockholders and an immediate dilution in as adjusted
net tangible book value of approximately
$ per share to purchasers of our
common stock in this offering, as illustrated by the following
table:
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Public offering price per share
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$
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Net tangible book value (deficit) per share as of
December 31, 2010
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$
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(0.14
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)
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Increase in per share attributable to investors purchasing our
common stock in this offering
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$
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As adjusted net tangible book value per share as of
December 31, 2010 after giving effect to this offering
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$
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Dilution per share to investors purchasing our common stock in
this offering
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$
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If the underwriters exercise in full their option to
purchase additional
shares of common stock at the public offering price of
$ per share, the as adjusted net
tangible book value after this offering would be approximately
$ per share, representing an
increase in net tangible book value of approximately
$ per share to existing
stockholders and immediate dilution in net tangible book value
of approximately $ per share to new
investors purchasing our common stock in this offering at the
public offering price.
The number of shares of common stock to be outstanding after
this offering is based on 81,248,472 shares outstanding as
of December 31, 2010 and excludes as of such date:
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7,806,671 shares of common stock issuable upon the exercise
outstanding stock options as of December 31, 2010, at a
weighted average exercise price of $3.73 per share; and
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an aggregate of 3,064 shares of common stock reserved for
future issuance under our 2006 Stock Incentive Plan.
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To the extent that outstanding options are exercised, you will
experience further dilution. In addition, we may choose to raise
additional capital due to market conditions or strategic
considerations even if we believe we have sufficient funds for
our current or future operating plans. To the extent that
additional capital is raised through the sale of equity or
convertible debt securities, the issuance of these securities
could result in further dilution to our stockholders.
S-16
CERTAIN
U.S. FEDERAL INCOME AND ESTATE TAX CONSEQUENCES TO
NON-U.S.
HOLDERS OF COMMON STOCK
The following is a summary of certain U.S. federal income
tax consequences of the purchase, ownership, and disposition of
common stock by a
non-U.S. holder
(as defined below) that acquires our common stock in this
offering and holds it as a capital asset. This discussion is
based upon the Internal Revenue Code of 1986, as amended, which
we refer to as the Code, effective U.S. Treasury
regulations, and judicial decisions and administrative
interpretations thereof, all as of the date hereof and all of
which are subject to change, possibly with retroactive effect.
The foregoing are subject to differing interpretations which
could affect the tax consequences described herein. This
discussion does not address all aspects of U.S. federal
income taxation that may be applicable to investors in light of
their particular circumstances, or to investors subject to
special treatment under U.S. federal income tax laws, such
as financial institutions, insurance companies, tax-exempt
organizations, entities that are treated as partnerships for
U.S. federal income tax purposes, dealers in securities or
currencies, expatriates, persons deemed to sell common stock
under the constructive sale provisions of the Code, and persons
that hold common stock as part of a straddle, hedge, conversion
transaction, or other integrated investment. Furthermore, this
discussion does not address any state, local or foreign tax laws.
You are
urged to consult your tax advisors regarding the U.S. federal,
state, local, and foreign income and other tax consequences of
the purchase, ownership, and disposition of our common stock,
including the consequences under any applicable tax
treaty.
For purposes of this summary, you are a
non-U.S. holder
if you are a beneficial owner of common stock that, for
U.S. federal income tax purposes, is not:
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an individual that is a citizen or resident of the United States;
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a corporation, other entity treated as a corporation for
U.S. federal income tax purposes, or partnership that is
created or organized under the laws of the United States, any
state thereof, or the District of Columbia;
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an estate the income of which is subject to U.S. federal
income taxation regardless of its source; or
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a trust, provided that, (1) a court within the United
States is able to exercise primary supervision over its
administration or one or more U.S. persons (as defined in
the Code) have the authority to control all substantial
decisions of that trust, or (2) the trust has made an
election under the applicable Treasury regulations to be treated
as a U.S. person.
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If a partnership (including any entity or arrangement treated as
a partnership for U.S. federal income tax purposes) owns
our common stock, the U.S. federal income tax treatment of
a partner in the partnership generally will depend upon the
status of the partner and the activities of the partnership.
Partners in a partnership that owns our common stock should
consult their tax advisors as to the particular
U.S. federal income tax consequences applicable to them.
Dividends
Except as described below, if you are a
non-U.S. holder
of common stock, dividends paid to you are subject to
withholding of U.S. federal income tax at a 30% rate or at
a lower rate if you are eligible for the benefits of an income
tax treaty that provides for a lower rate. Even if you are
eligible for a lower treaty rate, we and other payors will
generally be required to withhold at a 30% rate (rather than the
lower treaty rate) on dividend payments to you, unless you have
furnished to us or another payor:
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a valid Internal Revenue Service
Form W-8BEN
or an acceptable substitute form upon which you certify, under
penalties of perjury, your status as (or, in the case of a
U.S. alien holder that is a partnership or an estate or
trust, such forms certifying the status of each partner in the
partnership or beneficiary of the estate or trust as) a non-
U.S. person and your entitlement to the lower treaty rate
with respect to such payments; or
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S-17
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in the case of payments made outside the United States to an
offshore account (generally, an account maintained by you at an
office or branch of a bank or other financial institution at any
location outside the United States), other documentary evidence
establishing your entitlement to the lower treaty rate in
accordance with U.S. Treasury regulations.
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Special certification and other requirements apply to certain
non-U.S. holders
that are pass-through entities rather than companies or
individuals.
If you are eligible for a reduced rate of U.S. withholding
tax under a tax treaty, you may obtain a refund of any amounts
withheld in excess of that rate by filing a refund claim with
the U.S. Internal Revenue Service.
If dividends paid to you are effectively connected
with your conduct of a trade or business within the United
States, and you have not claimed the dividends are eligible for
any treaty benefits as income that is not attributable to a
permanent establishment that you maintain in the United States,
we and other payors generally are not required to withhold tax
from the dividends, provided that you have furnished to us or
another payor a valid Internal Revenue Service
Form W-8ECI
or an acceptable substitute form upon which you certify, under
penalties of perjury, that you are a non-U.S. person, and
the dividends are effectively connected with your conduct of a
trade or business within the United States and are includible in
your gross income. Effectively connected dividends
are taxed at rates applicable to U.S. persons on a net
income basis. If you are a corporate
non-U.S. holder,
effectively connected dividends that you receive
may, under certain circumstances, be subject to an additional
branch profits tax at a 30% rate or at a lower rate
if you are eligible for the benefits of an income tax treaty
that provides for a lower rate.
Disposition
of Common Stock
If you are a
non-U.S. holder,
you generally will not be subject to U.S. federal income
tax on gain from U.S. sources that you recognize on a
disposition of our common stock unless:
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the gain is effectively connected with your conduct
of a trade or business in the United States, and the gain is
attributable to a permanent establishment that you maintain in
the United States, if that is required by an applicable income
tax treaty as a condition for subjecting you to
U.S. taxation on a net income basis;
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you are an individual and you are present in the United States
for 183 or more days in the taxable year of the
disposition; or
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we have been a United States real property holding
corporation, or USRPHC, for U.S. federal income tax
purposes at any time within the shorter of the five-year period
preceding your disposition of our common stock or your holding
period for our common stock.
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Effectively connected gains are taxed at rates
applicable to U.S. persons on a net income tax basis. If
you are a corporate
non-U.S. holder,
effectively connected gains that you recognize may
also, under certain circumstances, be subject to an additional
branch profits tax at a 30% rate or at a lower rate
if you are eligible for the benefits of an income tax treaty
that provides for a lower rate.
An individual
non-U.S. holder
described in the second bullet point above will only be subject
to U.S. federal income tax on the gain from the sale of our
common stock to the extent such gain is deemed to be from
U.S. sources, which will generally only be the case where
the individuals tax home is in the United States. An
individuals tax home is generally considered to be located
at the individuals regular or principal (if more than one
regular) place of business. If the individual has no regular or
principal place of business because of the nature of the
business, or because the individual is not engaged in carrying
on any trade or business, then the individuals tax home is
his regular place of abode. If an individual
non-U.S. holder
is described in the second bullet point above, and the
individual
non-U.S. holders
tax home is in the United States, then the
non-U.S. holder
may be subject to a flat 30% tax on the gain derived from the
disposition, which gain may be offset by
U.S.-source
capital losses.
S-18
We believe we currently are not, and we do not anticipate
becoming, a USRPHC for U.S. federal income tax purposes.
However, because the determination of whether we are a USRPHC
depends on the fair market value of our United States real
property interests relative to the fair market value of our
other trade or business assets and our foreign real property
interests, there can be no assurance that we will not become a
USRPHC in the future. Even if we are or become a USRPHC, as long
as our common stock is regularly traded on an established
securities market, such common stock will be treated as a United
States real property interest with respect to you only if you
actually or constructively held more than 5% of such regularly
traded common stock during the applicable period.
Federal
Estate Taxes
Common stock held by a
non-U.S. holder
at the time of death generally will be included in the
holders gross estate for U.S. federal estate tax
purposes, unless an applicable estate tax treaty provides
otherwise.
Information
Reporting and Backup Withholding
We must report annually to the Internal Revenue Service and to
each
non-U.S. holder
the amount of dividends paid to such holder and the tax withheld
with respect to such dividends, regardless of whether
withholding was required. Copies of the information returns
reporting such dividends and withholding may also be made
available to the tax authorities in the country in which the
non-U.S. holder
resides under the provisions of an applicable income tax treaty.
A
non-U.S. holder
will be subject to backup withholding for dividends paid to such
holder unless such holder certifies under penalty of perjury
that it is a
non-U.S. holder
(and the payor does not have actual knowledge or reason to know
that such holder is a U.S. person as defined under the
Code), or such holder otherwise establishes an exemption.
Information reporting and, depending on the circumstances,
backup withholding will apply to the proceeds of a sale of our
common stock within the United States or conducted through
certain
U.S.-related
financial intermediaries, unless the beneficial owner certifies
under penalty of perjury that it is a
non-U.S. holder
(and the payor does not have actual knowledge or reason to know
that the beneficial owner is a U.S. person as defined under
the Code), or such owner otherwise establishes an exemption.
Any amounts withheld under the backup withholding rules may be
allowed as a refund or a credit against a
non-U.S. holders
U.S. federal income tax liability provided the required
information is furnished to the Internal Revenue Service.
Legislation
Affecting Taxation of Common Stock Held By or Through Foreign
Entities
Legislation was enacted on March 18, 2010 that will,
effective for payments made after December 31, 2012, impose
a 30% U.S. withholding tax on dividends paid by
U.S. issuers and on the gross proceeds from the disposition
of stock paid to a foreign financial institution, unless such
institution enters into an agreement with the U.S. Treasury
to collect and provide to the U.S. Treasury substantial
information regarding U.S. account holders with such
institution, including certain account holders that are foreign
entities with U.S. owners. The legislation also generally
imposes a withholding tax of 30% on dividends paid by
U.S. issuers and on the gross proceeds from the disposition
of stock paid to a non-financial foreign entity unless such
entity provides the withholding agent with a certification that
it does not have any substantial U.S. owners or a
certification identifying the direct and indirect substantial
U.S. owners of the entity. Under certain circumstances, a
holder may be eligible for refunds or credits of such taxes.
Investors are urged to consult with their own tax advisors
regarding the possible implications of this recently enacted
legislation on their investment in the common stock.
S-19
UNDERWRITING
Citigroup Global Markets Inc. and Barclays Capital Inc. are
acting as joint book-running managers of the offering. Subject
to the terms and conditions stated in the underwriting agreement
dated the date of this prospectus supplement, each underwriter
named below has severally agreed to purchase, and we have agreed
to sell to that underwriter, the number of shares set forth
opposite the underwriters name.
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Number
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Underwriter
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of Shares
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Citigroup Global Markets Inc.
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Barclays Capital Inc.
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Total
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The underwriting agreement provides that the obligations of the
underwriters to purchase the shares included in this offering
are subject to approval of legal matters by counsel and to other
conditions. The underwriters are obligated to purchase all the
shares (other than those covered by the over-allotment option
described below) if they purchase any of the shares.
Shares sold by the underwriters to the public will initially be
offered at the public offering price set forth on the cover of
this prospectus supplement. Any shares sold by the underwriters
to securities dealers may be sold at a discount from the public
offering price not to exceed $ per
share. If all the shares are not sold at the public offering
price, the underwriters may change the offering price and the
other selling terms.
If the underwriters sell more shares than the total number set
forth in the table above, we have granted to the underwriters an
option, exercisable for 30 days from the date of this
prospectus supplement, to purchase up
to
additional shares at the public offering price less the
underwriting discount. The underwriters may exercise the option
solely for the purpose of covering over-allotments, if any, in
connection with this offering. To the extent the option is
exercised, each underwriter must purchase a number of additional
shares approximately proportionate to that underwriters
initial purchase commitment. Any shares issued or sold under the
option will be issued and sold on the same terms and conditions
as the other shares that are the subject of this offering.
We and our officers and directors have agreed that, for a period
of 90 days from the date of this prospectus supplement, we
and they will not, without the prior written consent of
Citigroup Global Markets Inc. and Barclays Capital Inc., dispose
of or hedge any shares or any securities convertible into or
exchangeable for our common stock. Citigroup Global Markets Inc.
and Barclays Capital Inc. in their sole discretion may release
any of the securities subject to these
lock-up
agreements at any time without notice. The foregoing
restrictions do not apply to certain transactions, including:
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transactions relating to shares of common stock or other
securities acquired in the open market after the completion of
the offering;
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bona fide gifts;
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bona fide gifts, sales or other dispositions of shares of any
class of our capital stock, in each case that are made
exclusively between and among the undersigned or members of the
undersigneds immediate family (or a trust to their
benefit), or affiliates of the undersigned, including its
partners (if a partnership) or members (if a limited liability
company);
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the exercise of warrants or the exercise of stock options
granted pursuant to our stock option/incentive plans or
otherwise outstanding on the date hereof; provided, that the
restrictions shall apply to shares of common stock issued upon
such exercise or conversion; and
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the establishment of any contract, instruction or plan
(individually, a Plan and collectively,
Plans) that satisfies all of the requirements of
Rule 10b5-1(c)(1)(i)(B)
under the Exchange Act; provided, however, that no sales of
common stock or securities convertible into, or exchangeable or
exercisable for, common stock, shall be made pursuant to a Plan
prior to the expiration of the
lock-up
period (as the same may be extended pursuant to the provisions
hereof).
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S-20
Notwithstanding the foregoing, if (i) during the last
17 days of the
90-day
restricted period, we issue an earnings release or material news
or a material event relating to our company occurs; or
(ii) prior to the expiration of the
90-day
restricted period, we announce that we will release earnings
results during the
16-day
period beginning on the last day of the
90-day
restricted period, the restrictions described above shall
continue to apply until the expiration of the
18-day
period beginning on the issuance of the earnings release or the
occurrence of the material news or material event.
The shares are listed on the NYSE Amex and on the Tel Aviv Stock
Exchange, both under the symbol PLX.
The following table shows the underwriting discount that we are
to pay to the underwriters in connection with this offering.
These amounts are shown assuming both no exercise and full
exercise of the underwriters over-allotment option.
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Paid by the Company
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No Exercise
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Full Exercise
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Per share
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$
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$
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Total
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$
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$
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In connection with the offering, the underwriters may purchase
and sell shares in the open market. Purchases and sales in the
open market may include short sales, purchases to cover short
positions, which may include purchases pursuant to the
over-allotment option, and stabilizing purchases.
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Short sales involve secondary market sales by the underwriters
of a greater number of shares than they are required to purchase
in the offering.
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Covered short sales are sales of shares in an amount
up to the number of shares represented by the underwriters
over-allotment option.
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Naked short sales are sales of shares in an amount
in excess of the number of shares represented by the
underwriters over-allotment option.
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Covering transactions involve purchases of shares either
pursuant to the over-allotment option or in the open market
after the distribution has been completed in order to cover
short positions.
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To close a naked short position, the underwriters must purchase
shares in the open market after the distribution has been
completed. A naked short position is more likely to be created
if the underwriters are concerned that there may be downward
pressure on the price of the shares in the open market after
pricing that could adversely affect investors who purchase in
the offering.
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To close a covered short position, the underwriters must
purchase shares in the open market after the distribution has
been completed or must exercise the over-allotment option. In
determining the source of shares to close the covered short
position, the underwriters will consider, among other things,
the price of shares available for purchase in the open market as
compared to the price at which they may purchase shares through
the over-allotment option.
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Stabilizing transactions involve bids to purchase shares so long
as the stabilizing bids do not exceed a specified maximum.
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Purchases to cover short positions and stabilizing purchases, as
well as other purchases by the underwriters for their own
accounts, may have the effect of preventing or retarding a
decline in the market price of the shares. They may also cause
the price of the shares to be higher than the price that would
otherwise exist in the open market in the absence of these
transactions. The underwriters may conduct these transactions on
the NYSE Amex, in the
over-the-counter
market or otherwise. If the underwriters commence any of these
transactions, they may discontinue them at any time.
The underwriters may, from time to time, engage in transactions
with and perform services for us in the ordinary course of their
business for which they may receive customary fees and
reimbursement of expenses.
S-21
We have agreed to indemnify the underwriters against certain
liabilities, including liabilities under the Securities Act, or
to contribute to payments the underwriters may be required to
make because of any of those liabilities.
Notice to
Prospective Investors in the European Economic Area
In relation to each member state of the European Economic Area
that has implemented the Prospectus Directive (each, a relevant
member state), with effect from and including the date on which
the Prospectus Directive is implemented in that relevant member
state (the relevant implementation date), an offer to the public
of shares of our common stock described in this prospectus
supplement may not be made to the public in that relevant member
state prior to the publication of a prospectus in relation to
the shares of our common stock that has been approved by the
competent authority in that relevant member state or, where
appropriate, approved in another relevant member state and
notified to the competent authority in that relevant member
state, all in accordance with the Prospectus Directive, except
that, with effect from and including the relevant implementation
date, an offer of shares of our common stock may be made to the
public in that relevant member state at any time:
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to any legal entity which is a qualified investor as defined in
the Prospectus Directive;
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to fewer than 100 or, if the Relevant Member State has
implemented the relevant provision of the 2010 PD Amending
Directive, 150, natural or legal persons (other than qualified
investors as defined in the Prospectus Directive), as permitted
under the Prospectus Directive, subject to obtaining the prior
consent of the underwriters for any such offer; or
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in any other circumstances falling within Article 3(2) of
the Prospectus Directive.
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For purposes of this provision, the expression an offer to
the public in any relevant member state means the
communication in any form and by any means of sufficient
information on the terms of the offer and any shares of our
common stock to be offered so as to enable an investor to decide
to purchase or subscribe for shares of our common stock, as the
expression may be varied in that member state by any measure
implementing the Prospectus Directive in that member state, and
the expression Prospectus Directive means Directive
2003/71/EC (and amendments thereto, including the 2010 PD
Amending Directive, to the extent implemented in the Relevant
Member State), and includes any relevant implementing measure in
each relevant member state and the expression 2010 PD Amending
Directive means Directive 2010/73/EU.
This EEA selling restriction is in addition to any other selling
restrictions set out in this prospectus supplement.
Notice to
Prospective Investors in the United Kingdom
This prospectus supplement and the accompanying prospectus are
only being distributed to, and is only directed at, persons in
the United Kingdom that are qualified investors within the
meaning of Article 2(1)(e) of the Prospectus Directive that
are also (i) investment professionals falling within
Article 19(5) of the Financial Services and Markets Act
2000 (Financial Promotion) Order 2005 (the Order) or
(ii) high net worth entities, and other persons to whom it
may lawfully be communicated, falling within
Article 49(2)(a) to (d) of the Order (each such person
being referred to as a relevant person). This
prospectus supplement, the accompanying prospectus and their
contents are confidential and should not be distributed,
published or reproduced (in whole or in part) or disclosed by
recipients to any other persons in the United Kingdom. Any
person in the United Kingdom that is not a relevant person
should not act or rely on this document or any of its contents.
Notice to
Prospective Investors in France
Neither this prospectus supplement, the accompanying prospectus
nor any other offering material relating to the shares described
in this prospectus supplement and the accompanying prospectus
has been submitted to the clearance procedures of the
Autorité des Marchés Financiers or of the
competent authority of another member state of the European
Economic Area and notified to the Autorité des
Marchés Financiers. The shares have not been offered or
sold and will not be offered or sold, directly or indirectly, to
the public in France.
S-22
Neither this prospectus supplement, the accompanying prospectus
nor any other offering material relating to the shares has been
or will be:
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released, issued, distributed or caused to be released, issued
or distributed to the public in France; or
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used in connection with any offer for subscription or sale of
the shares to the public in France.
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Such offers, sales and distributions will be made in France only:
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to qualified investors (investisseurs qualifiés)
and/or to a
restricted circle of investors (cercle restreint
dinvestisseurs), in each case investing for their own
account, all as defined in, and in accordance with
articles L.411-2,
D.411-1, D.411-2, D.734-1, D.744-1, D.754-1 and D.764-1 of the
French Code monétaire et financier;
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to investment services providers authorized to engage in
portfolio management on behalf of third parties; or
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in a transaction that, in accordance with
article L.411-2-II-1°-or-2°-or
3° of the French Code monétaire et financier
and
article 211-2
of the General Regulations (Règlement
Général) of the Autorité des Marchés
Financiers, does not constitute a public offer (appel
public à lépargne).
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The shares may be resold directly or indirectly, only in
compliance with
articles L.411-1,
L.411-2, L.412-1 and L.621-8 through L.621-8-3 of the French
Code monétaire et financier.
Notice to
Prospective Investors in Hong Kong
The shares may not be offered or sold in Hong Kong by means of
any document other than (i) in circumstances which do not
constitute an offer to the public within the meaning of the
Companies Ordinance (Cap. 32, Laws of Hong Kong), or
(ii) to professional investors within the
meaning of the Securities and Futures Ordinance (Cap. 571, Laws
of Hong Kong) and any rules made thereunder, or (iii) in
other circumstances which do not result in the document being a
prospectus within the meaning of the Companies
Ordinance (Cap. 32, Laws of Hong Kong) and no advertisement,
invitation or document relating to the shares may be issued or
may be in the possession of any person for the purpose of issue
(in each case whether in Hong Kong or elsewhere), which is
directed at, or the contents of which are likely to be accessed
or read by, the public in Hong Kong (except if permitted to do
so under the laws of Hong Kong) other than with respect to
shares which are or are intended to be disposed of only to
persons outside Hong Kong or only to professional
investors within the meaning of the Securities and Futures
Ordinance (Cap. 571, Laws of Hong Kong) and any rules made
thereunder.
Notice to
Prospective Investors in Japan
The shares offered in this prospectus supplement have not been
registered under the Securities and Exchange Law of Japan. The
shares have not been offered or sold and will not be offered or
sold, directly or indirectly, in Japan or to or for the account
of any resident of Japan, except (i) pursuant to an
exemption from the registration requirements of the Securities
and Exchange Law and (ii) in compliance with any other
applicable requirements of Japanese law.
Notice to
Prospective Investors in Singapore
This prospectus supplement and the accompanying prospectus have
not been registered as a prospectus with the Monetary Authority
of Singapore. Accordingly, this prospectus supplement and the
accompanying prospectus and any other document or material in
connection with the offer or sale, or invitation for
subscription or purchase, of the shares may not be circulated or
distributed, nor may the shares be offered or sold, or be made
the subject of an invitation for subscription or purchase,
whether directly or indirectly, to persons in Singapore other
than (i) to an institutional investor under
Section 274 of the Securities and Futures Act,
Chapter 289 of Singapore (the SFA),
(ii) to a relevant person pursuant to Section 275(1),
or any person pursuant to Section 275(1A), and in
accordance with the conditions specified in Section 275 of
the SFA or
S-23
(iii) otherwise pursuant to, and in accordance with the
conditions of, any other applicable provision of the SFA, in
each case subject to compliance with conditions set forth in the
SFA.
Where the shares are subscribed or purchased under
Section 275 of the SFA by a relevant person which is:
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a corporation (which is not an accredited investor (as defined
in Section 4A of the SFA)) the sole business of which is to
hold investments and the entire share capital of which is owned
by one or more individuals, each of whom is an accredited
investor; or
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a trust (where the trustee is not an accredited investor) whose
sole purpose is to hold investments and each beneficiary of the
trust is an individual who is an accredited investor,
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shares, debentures and units of shares and debentures of that
corporation or the beneficiaries rights and interest
(howsoever described) in that trust shall not be transferred
within six months after that corporation or that trust has
acquired the shares pursuant to an offer made under
Section 275 of the SFA except:
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to an institutional investor (for corporations, under
Section 274 of the SFA) or to a relevant person defined in
Section 275(2) of the SFA, or to any person pursuant to an
offer that is made on terms that such shares, debentures and
units of shares and debentures of that corporation or such
rights and interest in that trust are acquired at a
consideration of not less than S$200,000 (or its equivalent in a
foreign currency) for each transaction, whether such amount is
to be paid for in cash or by exchange of securities or other
assets, and further for corporations, in accordance with the
conditions specified in Section 275 of the SFA;
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where no consideration is or will be given for the
transfer; or
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where the transfer is by operation of law.
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Notice to
Prospective Investors in Israel
This prospectus supplement and the accompanying prospectus are
not, and under no circumstances are to be construed as an
advertisement or a public offering of securities in Israel. Any
public offer or sale of securities in Israel may be made only in
accordance with the Israeli Securities Act-1968 (which requires,
inter alia, the filing of a prospectus in Israel or an exemption
therefrom).
S-24
LEGAL
MATTERS
Certain legal matters with respect to the common stock will be
passed upon for us by Morrison & Foerster LLP, New
York, New York. Latham & Watkins LLP, San Diego,
California, is counsel for the underwriters in connection with
this offering.
EXPERTS
The financial statements and managements assessment of the
effectiveness of internal control over financial reporting
(which is included in Managements Report on Internal
Control over Financial Reporting) incorporated in this
prospectus supplement and the accompanying prospectus by
reference to the Annual Report on
Form 10-K
for the year ended December 31, 2010 have been so
incorporated in reliance on the reports of Kesselman &
Kesselman, independent registered public accounting firm, and a
member firm of PricewaterhouseCoopers International Limited,
each member firm of which is a separate legal entity, given on
the authority of said firm as experts in auditing and accounting.
WHERE YOU
CAN FIND MORE INFORMATION
This prospectus supplement and the accompanying prospectus are
part of a registration statement on
Form S-3
that we filed with the SEC under the Securities Act. This
prospectus supplement and the accompanying prospectus do not
contain all of the information included in the registration
statement. We have omitted certain parts of the registration
statement in accordance with the rules and regulations of the
SEC. For further information, we refer you to the registration
statement, including its exhibits and schedules. Statements
contained in this prospectus supplement and the accompanying
prospectus about the provisions or contents of any contract,
agreement or any other document referred to are not necessarily
complete. Please refer to the actual exhibit for a more complete
description of the matters involved.
We file annual, quarterly and current reports, proxy statements
and other information with the SEC. Our SEC filings, including
the registration statement and exhibits, are available to the
public at the SECs website at
http://www.sec.gov.
You may also read, without charge, and copy the documents we
file, at the SECs public reference rooms at
100 F Street, N.E., Room 1580,
Washington, D.C. 20549. You can request copies of these
documents by writing to the SEC and paying a fee for the copying
cost. Please call the SEC at
1-800-SEC-0330
for further information on the public reference rooms. In
addition, since we are also listed on the Tel Aviv Stock
Exchange, we submit copies of all our filings with the SEC to
the Israeli Securities Authority and the Tel Aviv Stock
Exchange. Such copies can be retrieved electronically through
the Tel Aviv Stock Exchanges internet messaging system
(www.maya.tase.co.il) and through the MAGNA distribution site of
the Israeli Securities Authority (www.magna.isa.gov.il).
We maintain an Internet site at www.protalix.com. Webcasts of
presentations we make at certain conferences may also be
available on our website from time to time. We have not
incorporated by reference into this prospectus supplement or the
accompanying prospectus the information on our website, and you
should not consider any of the information posted on or
hyper-linked to our website to be a part of this prospectus
supplement or the accompanying prospectus.
S-25
INCORPORATION
OF CERTAIN DOCUMENTS BY REFERENCE
The SEC allows us to incorporate by reference the
information we file with the SEC, which means we can disclose
important information to you by referring you to those
documents. The information we incorporate by reference is an
important part of this prospectus supplement, and certain
information that we will later file with the SEC will
automatically update and supersede this information. We
incorporate by reference the documents listed below as well as
any future filings made with the SEC under Sections 13(a),
13(c), 14 or 15(d) of the Exchange Act after the date of this
prospectus supplement until we sell all of the securities under
this prospectus supplement, except that we do not incorporate
any document or portion of a document that is
furnished to the SEC, but not deemed
filed. The following documents filed with the SEC
are incorporated by reference in this prospectus supplement and
the accompanying prospectus:
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our Annual Report on
Form 10-K
for the year ended December 31, 2010 filed with the SEC on
February 23, 2011;
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our Current Reports on
Form 8-K
filed with the SEC on January 19, 2011; January 24,
2011; January 27, 2011; and February 25, 2011;
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the description of our common stock included in our registration
statement on Form
8-A12B (File
No. 001-33357)
filed with the SEC on March 9, 2007, including any
amendment or reports filed for the purpose of updating such
description.
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Copies of these filings are available at no cost on our website,
www.protalix.com. In addition, you may request a copy of these
filings and any amendments thereto at no cost, by writing or
telephoning us. Those copies will not include exhibits to those
documents unless the exhibits are specifically incorporated by
reference in the documents or unless you specifically request
them. You may also request copies of any exhibits to the
registration statement at no cost. Please direct your request to:
Yossi Maimon
2 Snunit Street
Science Park
POB 455
Carmiel, Israel 20100
+972-4-988-9488
S-26
PROSPECTUS
$150,000,000
Common Stock
We may, from time to time, offer to sell shares of our common
stock. The aggregate public offering price of the securities
that we may offer through this prospectus will be up to
$150,000,000.
We will provide the specific terms of the securities offered by
us in supplements to this prospectus, which we will deliver
together with the prospectus at the time of sale. This
prospectus may not be used to sell securities unless accompanied
by a prospectus supplement. Please read this prospectus and the
applicable prospectus supplement carefully before you invest in
any of our securities.
We may, from time to time, offer and sell these securities
directly or through one or more underwriters, agents or dealers,
through underwriting syndicates managed or co-managed by one or
more underwriters, or directly to purchasers, on or off the NYSE
Amex at prevailing market prices or at privately negotiated
prices, on a continuous or delayed basis.
Our common stock is listed on the NYSE Amex under the symbol
PLX and on the Tel Aviv Stock Exchange under the
symbol PLX. On January 6, 2011, the last
reported sale price of our common stock was $10.46 per share on
the NYSE Amex and NIS 36.75 per share on the Tel Aviv Stock
Exchange.
Investing in our securities
involves risks. Risks associated with an investment in our
securities will be described in the applicable prospectus
supplement and certain of our filings with the Securities and
Exchange Commission, as described under the caption Risk
Factors on page 4.
None of the Securities and Exchange Commission, the Israeli
Securities Authority or any state securities commission has
approved or disapproved of these securities or passed upon the
adequacy or accuracy of this prospectus. Any representation to
the contrary is a criminal offense.
The date of this prospectus is January 13, 2011
TABLE OF
CONTENTS
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10
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10
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No dealer, salesman or other person has been authorized to
give any information or to make any representations in
connection with the offer made by this prospectus or any
prospectus supplement other than those contained in, or
incorporated by reference in, this prospectus or any prospectus
supplement, and if given or made, such information or
representations must not be relied upon as having been
authorized by us or any underwriter, agent or dealer. We or an
authorized underwriter, agent or dealer may also furnish you
with a free writing prospectus relating to the applicable
securities. This prospectus, any prospectus supplement or any
free writing prospectus does not constitute an offer to sell or
a solicitation of any offer to buy any securities in any
jurisdiction to any person to whom it is unlawful to make an
offer or solicitation in such jurisdiction. The delivery of this
prospectus, any prospectus supplement or any free writing
prospectus at any time does not imply that the information
contained herein or therein is correct as of any time subsequent
to their respective dates.
CAUTIONARY
STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
The statements set forth and incorporated by reference in this
prospectus, 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 prospectus, or in
any document incorporated by reference in this prospectus, the
terms anticipate, believe,
estimate, expect and intend
and words or phrases of similar import, as they relate to us, or
our subsidiaries 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.
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 the potential rejection of any
applications we file with the U.S. Food and Drug
Administration, or the FDA, or other regulatory authorities,
including the New Drug Application (NDA) we have filed with the
FDA and the Marketing Authorization Application (MAA) we have
submitted to the European Medicines Agency, or the EMEA, for
taliglucerase alfa;
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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
relationship with Pfizer Inc., Teva Ltd. or with any other
collaborator, distributor or partner;
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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 product candidates, 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; and
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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
subsidiaries, our manufacturing facilities and our customers,
suppliers, distributors, collaborative partners, licensees and
clinical trial sites.
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In addition, companies in the pharmaceutical and biotechnology
industries have suffered significant setbacks in advanced or
late-stage clinical trials, even after obtaining promising
earlier trial results or preliminary findings for such clinical
trials. Even if favorable testing data is generated in clinical
trials of a drug product, the FDA might not accept or approve an
NDA, and the EMEA may not accept an MAA, filed or
1
submitted by a pharmaceutical or biotechnology company for the
drug product. These and other risks and uncertainties are
detailed in our Annual Report on
Form 10-K
for the year ended December 31, 2009, Section 1A,
under the heading Risk Factors, and described from
time to time in our future reports to be filed with the
Securities and Exchange Commission, or SEC.
Any or all of our 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 or revise, nor do we have a
policy of updating or revising, 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.
ABOUT
THIS PROSPECTUS
This prospectus is part of a registration statement that we
filed with the SEC using a shelf registration
process. Under this shelf registration process, we may sell
shares of common stock in one or more offerings, up to a total
dollar amount of $150,000,000.
This prospectus provides you with a general description of the
securities we may offer under this prospectus. Each time we sell
securities, we will provide a prospectus supplement that will
contain specific information about the terms of that offering.
The prospectus supplement may also add, update or change
information contained in this prospectus.
The SEC allows us to incorporate by reference
certain information that we file with it, which means that we
can disclose important information to you by referring you to
those documents. The information incorporated by reference is
considered to be part of this prospectus, and information that
we file later with the SEC will update automatically, supplement
and/or
supersede this information. Any statement contained in a
document incorporated or deemed to be incorporated by reference
in this prospectus shall be deemed to be modified or superseded
for purposes of this prospectus to the extent that a statement
contained in this prospectus or in any other document which also
is or is deemed to be incorporated by reference in this
prospectus modifies or supersedes such statement. Any such
statement so modified or superseded shall not be deemed, except
as so modified or superseded, to constitute a part of this
prospectus. You should read the detailed information regarding
our company, our common stock and our financial statements and
the notes to those statements appearing elsewhere in this
prospectus or incorporated herein by reference.
You should read both this prospectus and the applicable
prospectus supplement together with additional information from
the sources described under the caption Where You Can Find
More Information in this prospectus. You should not assume
that the information in this prospectus, the prospectus
supplements, any free writing prospectus or any document
incorporated by reference is accurate as of any date subsequent
to their respective dates.
You should rely only on the information provided or incorporated
by reference in this prospectus, any free writing prospectus and
any prospectus supplement, as applicable. We have not authorized
anyone to provide you with different information.
References in this prospectus to our company,
we, our, and us refer to
Protalix BioTherapeutics, Inc.
OUR
BUSINESS
We are a biopharmaceutical company focused on the development
and commercialization of recombinant therapeutic proteins based
on our proprietary
ProCellExTM
protein expression system, or ProCellEx. Using our ProCellEx
system, we are developing a pipeline of proprietary, biosimilar
or generic versions of 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. We believe our ProCellEx
protein expression system will enable us to
2
develop proprietary recombinant proteins that are
therapeutically equivalent or superior to existing recombinant
proteins currently marketed for the same indications. Because we
are primarily 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 taliglucerase alfa for
the treatment of Gaucher disease, which we are developing using
our ProCellEx protein expression system. Gaucher disease is a
rare and serious lysosomal storage disorder with severe and
debilitating symptoms. Taliglucerase alfa 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. In July 2007, we reached an
agreement with the U.S. Food and Drug Administration, or
the FDA, on the final design of our pivotal phase III
clinical trial of taliglucerase alfa, through the FDAs
special protocol assessment (SPA) process. The phase III
clinical trial was completed in September 2009 and, on
October 15, 2009, we announced positive top-line results
from the trial. On December 9, 2009, we filed our New Drug
Application (NDA) for taliglucerase alfa for the treatment of
Gaucher disease, and in January 2010 the FDA requested
additional data regarding the Chemistry, Manufacturing and
Controls (CMC) section of the NDA. We provided the
requested data in April 2010 and in July 2010 we received
notification from the FDA that it had accepted the filing of the
NDA and assigned a PDUFA date of February 25, 2011 to
taliglucerase alfa. In addition, in November 2010 we submitted a
Marketing Authorization Application to the European Medicines
Agency, or EMEA, for taliglucerase alfa for the treatment of
Gaucher disease.
In March 2010, the Israeli Ministry of Health completed a
successful audit of our manufacturing facilities in Carmiel,
Israel. The audit was performed as part of the Ministry of
Healths evaluation of our manufacturing process for
taliglucerase alfa.
In addition to our recently completed phase III clinical
trial of taliglucerase alfa, during the third quarter of 2008,
we initiated a double-blind, follow-on extension study as part
of the trial. We also initiated a home care treatment program
for patients enrolled in the extension study and in December
2008, we initiated a nine-month, worldwide, multi-center,
open-label, switch-over clinical study evaluating the safety and
efficacy of switching Gaucher patients currently treated under
the current standard of care to treatment with taliglucerase
alfa. The current standard of care for Gaucher patients is
enzyme replacement therapy with
CerezymeTM
which is produced by Genzyme Corporation and, until the recent
approval of
VPRIVTM
by Shire plc in February 2010, the only approved enzyme
replacement therapy for Gaucher disease. Enzyme replacement
therapy is a medical treatment in which recombinant enzymes are
injected into patients in whom the enzyme is lacking or
dysfunctional. The switch-over study is not a prerequisite for
approval of taliglucerase alfa by the FDA. In December 2009 we
filed a proposed pediatric investigation plan to the Pediatric
Committee of the EMEA which was approved during the second
quarter of 2010. In November 2010, we announced positive
preliminary data from the first 15 patients that completed
the switch-over clinical study of taliglucerase alfa.
On November 30, 2009, Protalix Ltd. and Pfizer Inc., or
Pfizer, entered into an exclusive license and supply agreement
pursuant to which Pfizer was granted an exclusive, worldwide
license to develop and commercialize taliglucerase alfa. Under
the terms and conditions of the Pfizer agreement, Protalix Ltd.
retained the right to commercialize taliglucerase alfa in
Israel. In connection with the execution of the Pfizer
agreement, Pfizer made an upfront payment to Protalix Ltd. of
$60.0 million in connection with the execution of the
agreement and subsequently paid Protalix Ltd. an additional
$5.0 million upon our filing of a proposed pediatric
investigation plan to the Pediatric Committee of the EMEA.
Protalix Ltd. is also eligible to receive potential milestone
payments totaling $50.0 million for the successful
achievement of other developmental milestones and to payments
equal to 40% of the net profits earned on Pfizers sales of
taliglucerase alfa, if any. Pfizer and Protalix Ltd. have agreed
to a specific allocation of the responsibilities for the
continued development efforts for taliglucerase alfa.
In July 2009, following a request by the FDA, we submitted a
treatment protocol to the FDA in order to address an expected
shortage of the current enzyme replacement therapy approved for
Gaucher disease. The treatment protocol was approved by the FDA
in August 2009. In September 2009, the FDAs Office of
Orphan
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Product Development granted taliglucerase alfa Orphan Drug
Status. In January 2010, the Committee for Orphan Medicinal
Products (COMP) of the EMEA, after reviewing all relevant
clinical data, recommended that the European Commission grant
orphan drug designation to taliglucerase alfa for the treatment
of Gaucher disease. The Orphan Drug designation in the United
States for taliglucerase alfa for the treatment of Gaucher
disease provides special status to taliglucerase alfa provided
that it meets certain criteria. As a result of the orphan
designation, we are qualified for the tax credit and marketing
incentives of the Orphan Drug Act of 1983. A marketing
application for a prescription drug product that has been
designated as a drug for a rare disease or condition is not
subject to a prescription drug user fee unless the application
includes an indication for other than a rare disease or
condition.
On July 13, 2010, we announced that the French regulatory
authority had granted an Autorisation Temporaire
dUtilisation (ATU), or Temporary Authorization for Use,
for taliglucerase alfa for the treatment of Gaucher disease. An
ATU is the regulatory mechanism used by the French Health
Products and Safety Agency to make non-approved drugs available
to patients in France when a genuine public health need exists.
This ATU allows patients with Gaucher disease in France to
receive treatment with taliglucerase alfa before marketing
authorization for the product is granted in the European Union.
Payment for taliglucerase alfa has been secured through
government allocations to hospitals.
On August 10, 2010, Pfizer entered into a $30 million
short-term supply agreement with the Ministry of Health of
Brazil pursuant to which we and Pfizer will provide
taliglucerase alfa to Gaucher disease patients in such country.
In addition to taliglucerase alfa, we are developing an
innovative product pipeline using our ProCellEx protein
expression system. Our product pipeline currently includes,
among other candidates, therapeutic protein candidates for the
treatment of Fabry disease, a rare, genetic lysosomal disorder
in humans, an acetylcholinesterase enzyme-based therapy for
biodefense, antiTNF, a plant cell expressed recombinant fusion
protein made from the soluble form of the human TNF receptor
(TNFR) which is being developed as a treatment of certain immune
diseases such as rheumatoid arthritis, juvenile idiopathic
arthritis and others, and additional undisclosed therapeutic
proteins and intoxication treatments, all of which are currently
being evaluated in animal studies. In March 2010, we initiated a
phase I clinical trial of PRX-105, our plant cell expressed
pegylated recombinant acetylcholinesterase product candidate for
biodefense indications, which we completed in June 2010. We are
currently preparing for further efficacy trials in larger
animals.
Except for the license we have granted to Pfizer, 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
taliglucerase alfa in Israel 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 common stock is listed on the NYSE Amex and, since
September 6, 2010, on the Tel Aviv Stock Exchange, both
under the symbol PLX.
ProCellExTM
is our trademark. Each of the other trademarks, trade names or
service marks appearing in this prospectus belongs to its
respective holder.
RISK
FACTORS
Investing in our securities involves a high degree of risk. You
should carefully consider the specific risks sets forth under
the caption Risk Factors in the applicable
prospectus supplement and under the captions Risk
Factors in any of our filings with the SEC, including our
Annual Report on
Form 10-K
for the year ended December 31, 2009 before making an
investment decision. For additional information, please see the
sources described under the caption Where You Can Find
More Information.
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USE OF
PROCEEDS
We will retain broad discretion over the use of the net proceeds
of the securities we offer hereby. Unless the applicable
prospectus supplement states otherwise, the net proceeds from
the securities we sell will be added to our general corporate
funds and may be used for research and development expenses,
clinical trials, establishing an internal sales force,
acquisitions of new technologies or businesses, and general
corporate and administrative purposes. Until the net proceeds
have been used, they will be invested in short-term bank
deposits or marketable securities. If we elect at the time of
the issuance of the securities to make different or more
specific uses of proceeds other than as described in this
prospectus, the change in use of proceeds will be described in
the applicable prospectus supplement.
DILUTION
We will set forth in a prospectus supplement the following
information regarding any material dilution of the equity
interests of investors purchasing securities in an offering
under this prospectus:
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the net tangible book value per share of our equity securities
before and after the offering;
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the amount of the increase in such net tangible book value per
share attributable to the cash payments made by purchasers in
the offering; and
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the amount of the immediate dilution from the public offering
price which will be absorbed by such purchasers.
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SECURITIES
WE MAY OFFER
Types of
Securities
We may offer, from time to time, shares of common stock through
this prospectus.
We will describe in a prospectus supplement, which we will
deliver with this prospectus at the time of sale, the terms of
the particular securities that we may offer in the future.
The aggregate initial offering price of all securities sold will
not exceed $150,000,000. When we sell securities, we will
determine the amounts of securities we will sell and the prices
and other terms on which we will sell them. We may sell
securities to or through underwriters, through agents or dealers
or directly to purchasers.
Additional
Information
We will describe in a prospectus supplement, which we will
deliver with this prospectus, the terms of the securities which
we may offer in the future. In each prospectus supplement we
will include the following information:
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the amount of securities which we propose to sell;
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the initial public offering price of the securities;
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the names of the underwriters, agents or dealers, if any,
through or to which we will sell the securities;
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the compensation, if any, of those underwriters, agents or
dealers;
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if applicable, information about any securities exchange or
automated quotation system on which the securities will be
listed or traded;
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material U.S. federal income tax considerations applicable
to the securities;
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any material risk factors associated with the securities;
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payment of dividends, if any;
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voting or other rights, if any; and
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any other material information about the offer and sale of the
securities.
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In addition, the prospectus supplement may add, update or change
the information contained in this prospectus.
DESCRIPTION
OF COMMON STOCK
We are a Florida corporation. The rights of our stockholders are
governed by the Florida Business Corporation Act, or the FBCA,
our amended and restated articles of incorporation and our
amended and restated bylaws. The following summary of the
material terms, rights and preferences of our capital stock is
not complete. You should read our amended and restated articles
of incorporation, which we refer to as our charter, and our
bylaws, for more complete information before you purchase any of
our securities. You should read these documents, copies of which
are available from us upon request at the address set forth
under the caption Where You Can Find More
Information, in order to more fully understand the terms
of our common stock.
General. Our charter provides that we may
issue up to 150,000,000 shares of common stock, par value
$0.001 per share, and 100,000,000 shares of preferred
stock, par value $0.0001 per share, all of which preferred stock
are undesignated. As of January 4, 2011,
81,269,472 shares of our common stock were issued and
outstanding and no shares of preferred stock were issued and
outstanding.
Holders of common stock are entitled to one vote for each share
held on all matters submitted to a vote of stockholders and do
not have cumulative voting rights. Accordingly, holders of a
majority of the shares of common stock entitled to vote in any
election of directors may elect all of the directors standing
for election. Holders of common stock are entitled to receive
dividends when, as and if declared by our board of directors out
of funds legally available therefor.
In the event of our liquidation, dissolution or winding up,
after payment of all of our debts and liabilities, the holders
of our common stock are entitled to share ratably in all
remaining assets available for distribution after the payment of
debts and liabilities and after provision has been made for each
class of stock, if any, having preferences over our common
stock. Holders of our common stock, as such, have no preemptive
or other rights and there are no redemption provisions
applicable to our common stock. All of our outstanding shares of
common stock are fully paid and nonassessable. The rights,
preferences and privileges of holders of common stock are
subject to, and may be adversely affected by, the rights of the
holders of shares of any series of preferred stock that we may
designate and issue in the future. In accordance with the rules
of the Tel Aviv Stock Exchange, other than stock options
under our 2006 Stock Option Plan, we may not issue any
securities of any class or series different than the common
stock that is listed on the Tel Aviv Stock Exchange for the
12-month
period immediately succeeding our initial listing, which
occurred on September 6, 2010. Subsequent to such
12-month
period, the rules of the Tel Aviv Stock Exchange allow us to
issue securities with preferential rights relating to dividends,
but such other securities may not include voting rights.
Dividend Policy. We have never declared or
paid any cash dividends on our capital stock. We currently
intend to retain any future earnings to finance the growth and
development of our business and therefore do not anticipate
paying any cash dividends in the foreseeable future. Any future
determination to pay cash dividends will be at the discretion of
our board of directors and will depend upon our financial
condition, operating results, capital requirements, covenants in
our debt instruments (if any), and such other factors as our
board of directors deems relevant.
Transfer Agent and Registrar. The transfer
agent and registrar of our common stock is American Stock
Transfer & Trust Company.
Options
As of January 4, 2011, options to purchase
7,785,671 shares of our common stock at a weighted average
exercise price equal to $3.72 per share were outstanding.
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Florida
Anti-Takeover Law Governance and Certain Charter
Provisions
We have elected not to be subject to the provisions of
Sections 607.0901 and 607.0902 of the FBCA.
Section 607.0902 of the FBCA prohibits the voting of shares
in a publicly-held Florida corporation that are acquired in a
control share acquisition unless the holders of a
majority of the corporations voting shares (exclusive of
shares held by officers of the corporation, inside directors or
the acquiring party) approve the granting of voting rights as to
the shares acquired in the control share acquisition or unless
the acquisition is approved by the corporations Board of
Directors. A control share acquisition is defined as
an acquisition that immediately thereafter entitles the
acquiring party to vote in the election of directors within each
of the following ranges of voting power: (i) one-fifth or
more but less than one-third of all voting power;
(ii) one-third or more but less than a majority of all
voting power; and (iii) more than a majority of all voting
power.
Sections 607.0901 of the FBCA contains an affiliated
transaction provision that prohibits a publicly-held
Florida corporation from engaging in a broad range of business
combinations or other extraordinary corporate transactions with
an interested shareholder unless, among others:
(i) the transaction is approved by a majority of
disinterested directors before the person becomes an interested
shareholder; (ii) the interested shareholder has owned at
least 80% of the corporations outstanding voting shares
for at least five years; or (iii) the transaction is
approved by the holders of two-thirds of the corporations
voting shares other than those owned by the interested
shareholder. An interested shareholder is defined as a person
who together with affiliates and associates beneficially owns
more than 10% of the corporations outstanding voting
shares.
NYSE Amex
and Tel Aviv Stock Exchange
Our common stock is listed on both the NYSE Amex and the Tel
Aviv Stock Exchange under the symbol PLX.
PLAN OF
DISTRIBUTION
We may sell the securities from time to time pursuant to
underwritten public offerings, negotiated transactions, at the
market offerings, block trades or a combination of these
methods. We may sell the securities to or through underwriters
or dealers, through agents, or directly to one or more
purchasers.
We may distribute securities from time to time in one or more
transactions:
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at a fixed price or prices, which may be changed;
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at market prices prevailing at the time of sale;
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at prices related to such prevailing market prices; or
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at negotiated prices.
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Unless stated otherwise in the applicable prospectus supplement,
the obligations of any underwriter to purchase securities will
be subject to certain conditions, and the underwriter will be
obligated to purchase all of the applicable securities if any
are purchased. If a dealer is used in a sale, we may sell the
securities to the dealer as principal. The dealer may then
resell the securities to the public at varying prices to be
determined by the dealer at the time of resale.
We or our agents may solicit offers to purchase securities from
time to time. Unless stated otherwise in the applicable
prospectus supplement, any agent will be acting on a best
efforts basis for the period of its appointment.
In connection with the sale of securities, underwriters or
agents may receive compensation (in the form of discounts,
concessions or commissions) from us or from purchasers of
securities for whom they may act as agents. Underwriters may
sell securities to or through dealers, and such dealers may
receive compensation in the form of discounts, concessions or
commissions from the underwriters
and/or
commissions from the purchasers for whom they may act as agents.
Underwriters, dealers and agents that participate in the
distribution of securities may be deemed to be underwriters, as
that term is defined in the Securities Act, and
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any discounts or commissions received by them from us and any
profits on the resale of the securities by them may be deemed to
be underwriting discounts and commissions under the Securities
Act. We will identify any such underwriter or agent, and we will
describe any compensation paid to them, in the related
prospectus supplement.
Underwriters, dealers and agents may be entitled under
agreements with us to indemnification against and contribution
toward certain civil liabilities, including liabilities under
the Securities Act.
If stated in the applicable prospectus supplement, we will
authorize agents and underwriters to solicit offers by certain
specified institutions or other persons to purchase securities
at the public offering price set forth in the prospectus
supplement under delayed delivery contracts providing for
payment and delivery on a specified date in the future.
Institutions with whom these contracts may be made include
commercial and savings banks, insurance companies, pension
funds, investment companies, educational and charitable
institutions, and other institutions, but shall in all cases be
subject to our approval. These contracts will be subject only to
those conditions set forth in the applicable prospectus
supplement and the applicable prospectus supplement will set
forth the commission payable for solicitation of these
contracts. The obligations of any purchaser under any such
contract will be subject to the condition that the purchase of
the securities shall not be prohibited at the time of delivery
under the laws of the jurisdiction to which the purchaser is
subject. The underwriters and other agents will not have any
responsibility in respect of the validity or performance of
these contracts.
The securities may or may not be listed on a national securities
exchange or traded in the over-the-counter market, as set forth
in the applicable prospectus supplement. No assurance can be
given as to the liquidity of the trading market for any of our
securities. Any underwriter may make a market in these
securities. However, no underwriter will be obligated to do so,
and any underwriter may discontinue any market making at any
time, without prior notice.
If underwriters or dealers are used in the sale, until the
distribution of the securities is completed, SEC rules may limit
the ability of any underwriters and selling group members to bid
for and purchase the securities. As an exception to these rules,
representatives of any underwriters are permitted to engage in
certain transactions that stabilize the price of the securities.
These transactions may consist of bids or purchases for the
purpose of pegging, fixing or maintaining the price of the
securities. If the underwriters create a short position in the
applicable securities in connection with any offering (in other
words, if they sell more securities than are set forth on the
cover page of the applicable prospectus supplement) the
representatives of the underwriters may reduce that short
position by purchasing securities in the open market. The
representatives of the underwriters may also elect to reduce any
short position by exercising all or part of any over-allotment
option we may grant to the underwriters, as described in the
prospectus supplement. The representatives of the underwriters
may also impose a penalty bid on certain underwriters and
selling group members. This means that if the representatives
purchase securities in the open market to reduce the
underwriters short position or to stabilize the price of
the securities, they may reclaim the amount of the selling
concession from the underwriters and selling group members who
sold those shares as part of the offering.
In general, purchases of a security for the purpose of
stabilization or to reduce a short position could cause the
price of the security to be higher than it might be in the
absence of those purchases. The imposition of a penalty bid
might also have an effect on the price of the securities to the
extent that it discourages resales of the securities. The
transactions described above may have the effect of causing the
price of the securities to be higher than it would otherwise be.
If commenced, the representatives of the underwriters may
discontinue any of the transactions at any time. In addition,
the representatives of any underwriters may determine not to
engage in those transactions or that those transactions, once
commenced, may be discontinued without notice.
Certain of the underwriters or agents and their associates may
engage in transactions with and perform services for us or our
affiliates in the ordinary course of their respective businesses.
In no event will the commission or discount received by any
Financial Industry Regulatory Authority, or FINRA, member or
independent broker-dealer participating in a distribution of
securities exceed 8% of the
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aggregate principal amount of the offering of securities in
which that FINRA member or independent broker-dealer
participates.
WHERE YOU
CAN FIND MORE INFORMATION
This prospectus is part of a registration statement on
Form S-3
that we filed with the SEC under the Securities Act. You should
rely only on the information contained in this prospectus or
incorporated by reference in this prospectus. We have not
authorized anyone else to provide you with different
information. You should not assume that the information in this
prospectus is accurate as of any date other than the date on the
front cover of this prospectus, regardless of the time of
delivery of this prospectus or any sale of securities.
We file annual, quarterly and current reports, proxy statements
and other information with the SEC. Our SEC filings, including
the registration statement and exhibits, are available to the
public at the SECs website at
http://www.sec.gov.
You may also read, without charge, and copy the documents we
file, at the SECs public reference rooms at
100 F Street, N.E., Room 1580,
Washington, D.C. 20549. You can request copies of these
documents by writing to the SEC and paying a fee for the copying
cost. Please call the SEC at
1-800-SEC-0330
for further information on the public reference rooms. In
addition, since we are also listed on the Tel Aviv Stock
Exchange, we submit copies of all our filings with the SEC to
the Israeli Securities Authority and the Tel Aviv Stock
Exchange. Such copies can be retrieved electronically through
the Tel Aviv Stock Exchanges internet messaging system
(www.maya.tase.co.il) and through the MAGNA distribution site of
the Israeli Securities Authority (www.magna.isa.gov.il).
We maintain an Internet site at www.protalix.com. Webcasts of
presentations we make at certain conferences may also be
available on our website from time to time. We have not
incorporated by reference into this prospectus the information
on our website, and you should not consider it to be a part of
this prospectus.
This prospectus does not contain all of the information included
in the registration statement. We have omitted certain parts of
the registration statement in accordance with the rules and
regulations of the SEC. For further information, we refer you to
the registration statement, including its exhibits and
schedules, which may be found at the SECs website at
http://www.sec.gov. Statements contained in this prospectus and
any accompanying prospectus supplement about the provisions or
contents of any contract, agreement or any other document
referred to are not necessarily complete. Please refer to the
actual exhibit for a more complete description of the matters
involved.
INCORPORATION
OF CERTAIN DOCUMENTS BY REFERENCE
The SEC allows us to incorporate by reference the
information we file with the SEC, which means we can disclose
important information to you by referring you to those
documents. The information we incorporate by reference is an
important part of this prospectus, and certain information that
we will later file with the SEC will automatically update and
supersede this information. We incorporate by reference the
documents listed below as well as any future filings made with
the SEC under Sections 13(a), 13(c), 14 or 15(d) of the
Exchange Act from the date of the initial registration statement
and prior to the effectiveness of this registration statement,
and any filings made after the date of this prospectus until we
sell all of the securities under this prospectus, except that we
do not incorporate any document or portion of a document that is
furnished to the SEC, but not deemed
filed. The following documents filed with the SEC
are incorporated by reference in this prospectus:
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our Annual Report on
Form 10-K
for the year ended December 31, 2009;
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our Quarterly Report on
Form 10-Q
for the quarters ended March 31, 2010; June 30, 2010;
and September 30, 2010;
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our Current Reports on
Form 8-K
filed with the SEC on January 14, 2010; February 2,
2010; February 5, 2010; February 11, 2010;
March 3, 2010; March 9, 2010; March 17, 2010;
April 27, 2010; May 18, 2010; June 8, 2010;
July 12, 2010; July 13, 2010, August 16, 2010,
August 30, 2010;
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September 7, 2010; September 13, 2010;
October 25, 2010; November 2, 2010; November 10,
2010; and November 29, 2010;
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our definitive Proxy Statement for our Annual Meeting of
Shareholders held on November 7, 2010; and
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the description of our common stock included in our
Form 8-A
filed with the SEC on March 9, 2007.
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Copies of these filings are available at no cost on our website,
www.protalix.com. In addition, you may request a copy of these
filings and any amendments thereto at no cost, by writing or
telephoning us. Those copies will not include exhibits to those
documents unless the exhibits are specifically incorporated by
reference in the documents or unless you specifically request
them. You may also request copies of any exhibits to the
registration statement at no cost. Please direct your request to:
Yossi
Maimon
2 Snunit Street
Science Park
POB 455
Carmiel, Israel 20100
+972-4-988-9488
You should rely only on the information in this prospectus, any
prospectus supplement, any applicable free writing prospectus
and the documents that are incorporated by reference. We have
not authorized anyone else to provide you with different
information. We are not offering these securities in any state
where the offering is prohibited by law. You should not assume
that the information in this prospectus, any prospectus
supplement, any applicable free writing prospectus or any
incorporated document is accurate as of any date other than the
date of the document.
LEGAL
MATTERS
The validity of the issuance of the shares of common stock
offered hereby will be passed upon for us by
Morrison & Foerster LLP, New York, New York.
EXPERTS
The financial statements and managements assessment of the
effectiveness of internal control over financial reporting
(which is included in Managements Report on Internal
Control over Financial Reporting) incorporated in this
Prospectus by reference to the Annual Report on
Form 10-K
for the year ended December 31, 2009 have been so
incorporated in reliance on the reports of Kesselman &
Kesselman, independent registered public accounting firm, and a
member of PricewaterhouseCoopers International Limited, each
member firm of which is a separate legal entity, given on the
authority of said firm as experts in auditing and accounting.
10
Shares
Common Stock
PRELIMINARY PROSPECTUS SUPPLEMENT
March , 2011
Joint
Book-Running Managers
Citi
Barclays Capital