F-3
As filed with the Securities and Exchange Commission on March 28, 2006.
Registration
No. 333-
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM F-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT
OF 1933
pSivida Limited
(Exact name of Registrant as specified in its charter)
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Western Australia,
Commonwealth of Australia
(State or other jurisdiction of
incorporation or organization)
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2834
(Primary Standard Industrial
Classification Code Number)
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Not
Applicable
(I.R.S. Employer
Identification No.) |
Level 12 BGC Centre
28 The Esplanade
Perth WA 6000
Australia
61 (8) 9226 5099
(Address, including zip code, and telephone number, including area code, of Registrants principal executive offices)
Lori Freedman, Esq.
Vice President for Corporate Affairs, General Counsel and Secretary
pSivida Inc.
400 Pleasant Street
Watertown, MA 02472
(617) 926-5000
(Name, address, including zip code, and telephone number, including area code, of agent for service)
Copies to:
Lawrence Goodman, Esq.
Peter F. Stewart, Esq.
Curtis, Mallet-Prevost, Colt & Mosle LLP
101 Park Avenue
New York, NY 10178
Tel: (212) 696-6000
Fax: (212) 697-1559
Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this registration statement.
If any of the securities being registered on this Form are to be offered on a delayed or continuous
basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. þ
If this Form is filed to register additional securities for an offering pursuant to Rule 462(b)
under the Securities Act, check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same offering. o
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act,
check the following box and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering. o
If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act,
check the following box and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering. o
If this
Form is a registration statement pursuant to General Instruction I.C.
or a post-effective amendment thereto that shall become effective
upon filing with the Commission pursuant to Rule 462(e) under the
Securities Act, check the following box. o
If this
Form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.C.
filed to register additional securities or additional classes of
securities pursuant to Rule 413(b) under the
Securities Act, check the following box. o
If delivery of the prospectus is expected to be made pursuant to Rule 434, please check the
following box. o
CALCULATION OF REGISTRATION FEE
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Title of Each Class of |
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Proposed Maximum Offering |
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Proposed Maximum |
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Amount of Registration |
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Securities to be Registered (1) |
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Amount to be Registered (2) |
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Price Per Share |
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Aggregate Offering Price |
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Fee |
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Ordinary Shares,
no par value |
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5,150,000 |
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$0.515(3) |
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$2,652,250 |
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$284 |
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Ordinary Shares
underlying selling
shareholder warrants |
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515,000 |
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$1.25(4) |
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$643,750 |
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$69 |
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(1) |
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American Depositary Shares (ADSs) evidenced by American Depositary Receipts issuable on
deposit of the equity shares registered hereby have been registered under a separate statement on
Form F-6, Registration No. 333-122158. Each ADS represents ten ordinary shares.
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(2) |
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The amount to be registered consists of up to 5,665,000 ordinary shares represented by 566,500
ADSs that may be offered and sold by the selling shareholders identified in the accompanying
prospectus from time to time. |
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(3) |
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Estimated solely for the purpose of computing the amount of the registration fee pursuant to
Rule 457(o) of the Securities Act of 1933, as amended, on the basis of the average of the high and
low prices of the ordinary shares represented by the ADSs on the NASDAQ National Market on March
22, 2006. |
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(4) |
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Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(g)
of the Securities Act, based on the higher of (a) the exercise price of the warrants or (b) the
offering price of securities of the same class included in this registration statement. |
The registrant hereby amends this registration statement on such date or dates as may be
necessary to delay its effective date until the registrant shall file a further amendment which
specifically states that this registration statement shall thereafter become effective in
accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement
shall become effective on such date as the Commission acting pursuant to said Section 8(a), may
determine.
The information in this prospectus is not complete and may be changed. We may
not sell these securities until the registration statement filed with the
Securities and Exchange Commission is effective. This prospectus is not an
offer to sell these securities and it is not soliciting an offer to buy these
securities in any, jurisdiction where the offer or sale is not permitted.
Preliminary Prospectus, subject to completion, dated March 28, 2006.
PSIVIDA LIMITED
566,500 American Depositary Shares
representing 5,665,000 Ordinary Shares
The selling shareholders may offer and sell from time to time an aggregate of up to
566,500 American Depositary Shares (ADSs), each of which is evidenced by an American Depository
Receipt and represents ten of our ordinary shares. These ADSs were acquired by the selling
shareholders pursuant to either private placements or other exempt transactions between us and the
selling shareholders. All of the ADSs listed in this prospectus are being sold by the selling
shareholders named in this prospectus or their respective transferees, pledgees, donees or
successors-in-interest. The selling shareholders will receive all proceeds from the sale of the
ADSs being offered in this prospectus. We may receive proceeds from the exercise of certain
warrants held by the selling shareholders, of which the underlying shares are also being registered
hereby, if the selling shareholders exercise those warrants through a cash exercise.
This offering is not being underwritten. The selling shareholders may sell the ADSs being
offered by them from time to time on the NASDAQ National Market, in market transactions, in
negotiated transactions or otherwise, and at prices and at terms that will be determined by the
then prevailing market price for the ADSs or by a combination of such methods of sale. For
additional information on the methods of sale, you should refer to the section entitled Plan of
Distribution.
Our ADSs are quoted on the NASDAQ National Market under the symbol PSDV. The last reported
sale price of our ADSs on the NASDAQ National Market on March 22, 2006 was US$5.05.
Our ordinary shares are listed on the Australian Stock Exchange under the symbol PSD. On
March 22, 2006, the closing price of our ordinary shares on the Australian Stock Exchange was
A$0.73, equivalent to a price of approximately US$5.26 per ADS based on the Federal Reserve Bank of
New York noon buying exchange rate on that date of A$1.00 = US$0.7204. Our ordinary shares are
also listed on the Frankfurt, Berlin, Munich and Stuttgart stock exchanges under the symbol PSI
and on the OFEX International Market Service under the symbol PSD.
Investing in our ADSs involves risks. See Risk Factors beginning on page 6.
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY OTHER REGULATORY BODY HAS APPROVED OR
DISAPPROVED OF THESE SECURITIES OR PASSED UPON THE ACCURACY OR ADEQUACY OF THIS PROSPECTUS. ANY
REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.
TABLE OF CONTENTS
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You should rely only on the information contained in this prospectus. We have not authorized
anyone to provide you with information that is different. This prospectus is not an offer to sell,
nor is it seeking an offer to buy, these securities in any jurisdiction where the offer or sale of
these securities is not permitted. You should assume that the information contained in this
prospectus is accurate as of the date on the front of this prospectus only.
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References in this prospectus to pSivida, the company, we, us, our, or similar terms
refer to pSivida Limited, except as otherwise indicated. On December 30, 2005 we completed the
acquisition of Control Delivery Systems, Inc., which was renamed pSivida Inc. We make reference to
Control Delivery Systems as CDS or as pSivida Inc. generally depending on whether such
reference relates to that company before or after the acquisition.
In this registration statement, references to A$ are to Australian dollars and references to
US$ and US dollars are to United States dollars, except for in the financial statements, where
references to $ are to Australian dollars and references to US$ are to United States dollars.
On June 30, 2004, the Federal Reserve Bank of New York Noon Buying Rate was US$0.6952 = A$1.00, on
June 30, 2005 such exchange rate was US$0.7618 = A$1.00 and on December 31, 2005 such exchange rate
was US$0.7342 = A$1.00.
THE COMPANY
We are an Australian public company listed on the Australian Stock Exchange, the NASDAQ
National Market, Frankfurt Stock Exchange and Londons OFEX International Market Service and
existing pursuant to the Australian Corporations Act 2001. Our corporate headquarters are located
at Level 12 BGC Centre, 28 The Esplanade, Perth WA 6000, Australia and our phone number is +61 (8)
9226 5099. We also operate subsidiaries in the United Kingdom, Singapore, Australia and the United
States.
We are a global nanotechnology company focused on the development of BioSilicon, a novel
porous form of nano-sized silicon, for therapeutic and diagnostic use in healthcare. BioSilicon is
composed of elemental silicon, engineered to create a honeycomb structure of pores. These pores
can be formed into a diverse array of shapes and sizes and can be filled with various drugs, genes
and proteins. We are working toward developing applications for controlled slow release drug
delivery and diagnostics. Initially, we are using BioSilicon to target primary liver cancer, but we
intend to investigate BioSilicons use as a treatment for other inoperable tumors such as
pancreatic, secondary liver and tumors within the peritoneum, brain and lung. We are currently
conducting a Phase IIb dose optimization BioSilicon trial in inoperable primary liver cancer
patients in seven centers in South-East Asia, including Singapore General Hospital. Other potential
applications for BioSilicon may include tissue engineering, orthopedics and food science.
On December 30, 2005 we completed the acquisition of CDS, which was renamed pSivida Inc.
pSivida Inc. designs and develops innovative sustained-release drug delivery products. Our two
proprietary drug delivery systems, AEON and CODRUG, deliver specific quantities of drugs directly
to a target site in the body at controlled rates for predetermined periods of time ranging from
days to years. These systems are designed to address drawbacks of systemic drug delivery for our
target diseases: adverse side effects characteristic of high dosing levels and reduced treatment
benefits due to variations in drug levels at the target site.
pSivida Inc. has two commercial products utilizing the AEON system approved by the U.S. Food
and Drug Administration for treatment of two sight threatening eye diseases. These two products,
Vitrasert® and Retisert, are the only local sustained-release products approved by the FDA for the
back of the eye. Marketed by Bausch & Lomb Incorporated and sold since 1996, Vitrasert is one of
the most effective treatments for CMV retinitis, a disease that afflicts late-stage AIDS patients.
Approved by the FDA in April 2005 and also marketed by Bausch & Lomb, Retisert treats chronic
noninfectious uveitis affecting the posterior segment of the eye, or posterior uveitis, a leading
cause of vision loss. Bausch & Lomb is also conducting two long-term multi-center clinical trials
of Retisert for the treatment of DME, another leading cause of vision loss. Medidur, an injectable
AEON product, is also designed to treat DME and is currently in fast-track Phase III clinical
trials conducted by Alimera Sciences Inc. pSivida Inc. also has two AEON product candidates in
pre-clinical studies for other back of the eye diseases.
Our lead BioSilicon product, BrachySil is based on a radioactive 32-phosphorous form of
BioSilicon. BrachySil offers interventional radiologists a short-range, longer life isotope that
can be delivered through a fine bore needle, making it a more user-friendly product for both
patient and physician. We are currently conducting Phase IIb BrachySil dose optimization trials on
inoperable primary liver cancer patients at Singapore General Hospital.
BioSilicon is composed of elemental silicon, one of the most abundant elements on the earths
crust, which is engineered to create a honeycomb structure of pores. We believe that
BioSilicons features include:
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Biocompatibility BioSilicon is biocompatible, meaning, it is not injurious and
does not cause immunological rejection within the body. |
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Non-toxicity our studies have shown that BioSilicon degrades in the body into
silicic acid, the non-toxic, dietary form of silicon which is found in beer, cereal
grains and wine. |
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Biodegradability BioSilicon can be made biodegradable in vivo (in animals and
humans) and in vitro (in solution). The rate of biodegradation depends on the degree
of nanostructuring that is imparted on the material. Thus, we believe that BioSilicon
can be made to dissolve in suitable environments in days, weeks or months, depending
upon the size and nature of the BioSilicon implanted. |
Because of these qualities, BioSilicon has the potential to serve as a biomedical device in or
on the body. pSivida believes that BioSilicon may have multiple potential applications in
healthcare. pSivida is currently working toward developing applications for controlled slow
release drug delivery and diagnostics. pSivida believes that other potential applications may
include orthopedics, tissue engineering, and food science (food sensors and nutraceutical
products).
Our Strategy
Our commercialization strategy is to concentrate on: internal product development based on
BioSilicon; licensing of the BioSilicon technology platform; and potential sale of non-core
intellectual property. Following our recent acquisition of CDS, we will also focus on the
development and commercialization of products based upon the AEON and CODRUG technologies, both
internally and by means of strategic collaborations.
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The focus of our internal product development is BioSilicon drug delivery, with an
initial emphasis on brachytherapy products. Other potential BioSilicon drug delivery
products are localized chemotherapy, slow release drugs and the delivery of generic
drugs (commonly referred to as re-delivered generics). We have established
commercialization plans for BrachySil, pSividas lead product, based upon market sizes,
benefits offered to patients and alternative competitive therapies. |
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We believe that the platform has now been developed to a stage where licensing
BioSilicon to large pharmaceutical and biotech companies for delivery of their patented
drugs is possible. We also intend to license diagnostic and sensor applications of the
BioSilicon platform technology developed by its subsidiary, AION Diagnostics. |
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We believe that sales of early stage non-core applications for BioSilicon may become
another possible source of near-term revenue. Such applications include biomaterial in
orthopedics, tissue engineering and regenerative medicine producing. |
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We believe that the acquisition of CDS will provide us with additional opportunities
for strategic growth by providing us with a US presence, greater access to the US
market, a range of products and product candidates based upon CDS drug-delivery
technologies and strategic collaborations to develop and market these products. |
Recent Developments
In September 2005, we raised US$4.3 million (A$5.7 million) in gross proceeds in a private
placement structured as a private investment in public equity, commonly known as a PIPE. In the
PIPE, we sold 665,000 ADSs to investors at US$6.50 per ADS and issued three-year warrants
exercisable for 133,000 ADSs at US$12.50 per ADS.
On October 27, 2005 we signed a license with Beijing Med-Pharm Corporation for the clinical
development, marketing and distribution of BrachySil in China. Under the terms of the license, we
will manufacture BrachySil and Beijing Med-Pharm will be responsible for clinical development,
securing regulatory approval, marketing and distribution in China. pSivida will retain
manufacturing rights for BrachySil under the license.
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On November 16, 2005, we issued a subordinated convertible promissory note in the principal
amount of US$15 million (A$19.7 million) to an institutional investor in a private placement. The
note bears interest at a rate equal to 8% per year, which we can pay in ADSs instead of cash if
certain conditions are met. The note has a term of three years and is convertible into ADSs at a
conversion price of US$7.10 per ADS, subject to adjustment based upon certain events or
circumstances, including, without limitation, the market price of ADSs for the ten trading days
ending August 5, 2006, if such price is lower than US$6.57. We also issued a warrant with a term
of six years which entitles the institutional investor to purchase up to 633,803 ADSs at US$7.20
per ADS, also subject to adjustment upon specified events. We have also entered into a
registration rights agreement pursuant to which we have agreed to file a registration statement
covering the resale of the ADSs underlying the note (as well as any ADSs received by the
institutional investor as interest under the note) and the warrant, as soon as practicable and to
have the registration statement declared effective within 180 days of issuance of the note and
warrant. The gross proceeds received by us in the private placement were US$15.0 million, and may
increase to approximately US $19.6 million if the warrant is exercised in full in cash. We expect
to use these proceeds for the expanded development of BioSilicon and for general corporate
purposes.
On October 3, 2005, we entered into a merger agreement with CDS, a Boston-based company
engaged in the design and development of drug delivery products. The merger agreement provided
that a newly-formed subsidiary of pSivida would merge into CDS, with CDS surviving the merger as a
wholly-owned subsidiary of pSivida with the name of pSivida Inc. After approval by the required
majorities of both companies shareholders and the fulfillment of other closing conditions, the
merger was completed on December 30, 2005. Pursuant to the merger, pSivida issued a total of
161,047,790 ordinary shares (represented by 16,104,779 ADSs) consisting of (i) 150,820,380 ordinary
shares (represented by 15,082,038 ADSs) in exchange for the outstanding CDS common and preferred
shares on the date of the acquisition in accordance with the merger agreement; (ii) 1,211,180
nonvested ordinary shares (represented by 121,118 nonvested ADSs) in connection with CDS employee
retention agreements; and (iii) 9,016,230 nonvested ordinary shares (represented by 901,623
nonvested ADSs) in exchange for the nonvested shares of CDS common stock outstanding on the date of
the acquisition in accordance with retention agreements between CDS and its officers and employees.
As of December 31, 2005, the ADSs received by the former CDS stockholders represented
approximately 41.3% of the capital stock of the combined company. Certain former shareholders of
CDS received cash rather than ADSs for their CDS shares. In addition, each outstanding option to
purchase CDS stock was assumed by us and converted into an option to acquire such number of ADSs as
the holder would have been entitled to receive in the merger if such holder had exercised such
option in full immediately before completion of the merger.
On February 10, 2006, we announced that Bausch & Lomb and Novartis Ophthalmics, a business
unit of Novartis Pharmaceutical Corp., had reached an agreement to co-promote Retisert in the
United States.
On February 21, 2006, we reported that preliminary data from Bausch & Lombs clinical trial of
Retisert for the treatment of chronic non-infectious posterior segment uveitis showed a lower
recurrence rate in eyes receiving Retisert than in non-implanted eyes. This study involved 278
patients from 27 hospitals in the United States and one in Singapore. The study showed that, at
three years, control of uveitis in eyes implanted with Retisert was better than in non-implanted
eyes, but was less effective than at two years and that some eyes may need to be re-implanted
between 24 and 36 months. In the study, patients received either a 0.59 mg or a 2.1 mg Retisert
device. Data presented was the aggregate of the two doses. At three years, the recurrence rate of
uveitis was 33% in the eye receiving Retisert compared to 57% of fellow eyes. A greater number of
eyes receiving Retisert experienced an improvement in vision of at least 15 letters (three lines on
an eye chart) compared to fellow eyes (22% versus 6%). 45% of eyes receiving Retisert required an
operation to relieve elevated intraocular pressure and 92% developed a cataract.
On March 17, 2006, we announced that our ADSs had been included in the Nanotechnology.com
Small Technology Index. Nanotechnology.com is owned by The Nanotech Company, LLC an independent
advisory firm specializing in advising nanotechnology companies.
On March 20, 2006, we announced that an independent audit of our Boston, Massachusetts
facility performed by a European Qualified Person had resulted in the issuance of a certificate
indicating that our product Medidur is manufactured to the standard of Good Manufacturing Practice
(GMP) set out in European Union directive 2003/94/EC and the EC Guide to Good Manufacturing
Practice.
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On March 20, 2006, we announced that following a planned interim review, an independent data
safety monitoring board, commonly known as a DSMB, had recommended the continuation of the Phase 3
clinical trial being conducted by us and Alimera Sciences Inc. involving our product Medidur.
Results for the Half Year Ended December 31, 2005
On March 16, 2006, we announced our unaudited half-year financial report for the half year
ended December 31, 2005. The consolidated entity changed its accounting policies on July 1, 2005
to comply with Australian Equivalents to International Financial Reporting Standards, or A-IFRS
(effective from July 1, 2005). The transition to A-IFRS is accounted for in accordance with
Accounting Standard AASB 1 First-time Adoption of Australian Equivalents to International
Financial Reporting Standards, with July 1, 2004 as the date of transition.
Revenue decreased to A$296,921 for the half year ended December 31, 2005 from A$398,501 for
the half year ended December 31, 2004, a decrease of A$101,580 or 25.5%. This decrease was the
result of a reduction in interest received during the period based on lower average cash balances
held.
Loss before income tax expense increased to A$13,070,400 for the half year ended December 31,
2005 from A$9,598,661 for the half year ended December 31, 2004, an increase of A$3,471,739 or
36.2%. This increase was the result of an increase in professional fees, employee expenses and
general office expenses due to increased corporate activities. These activities included private
placements of shares in the form of ADSs and a convertible promissory note and the acquisition of
CDS. Employee expenses increased 212% for the half year ended December 31, 2005 compared to the
half year ended December 31, 2004 as a result of an increase in staff. Staff numbers, excluding
directors, consultants and the staff of CDS, increased by 126% to 52 for the half year ended
December 31, 2005 compared to 23 for the half year ended December 31, 2004, as a result of our
increased research and development activities related to the applications of BioSilicon.
Research and development expense increased to A$5,698,842 for the half year ended December 31,
2005 from A$3,688,062 for the half year ended December 31, 2004, an increase of A$2,010,780 or
54.5%. This increase is the result of the commencement of Phase IIb clinical trials with our
product BrachySil as a potential new brachytherapy treatment for inoperable primary liver cancer.
Loss attributable to our shareholders increased to A$10,702,745 for the half year ended
December 31, 2005 from A$7,330,165 for the half year ended December 31, 2004, an increase of
A$3,372,580 or 46.0%
Our cash balance increased to A$27,683,278 for the half year period ended December 31, 2005,
compared to A$12,8892,061 for the half year ended December 31, 2004 an increase of A$14,791,217 or
215%, as a result of additional funding obtained by us in the private placements of ADSs and a
convertible promissory note which resulted in gross proceeds of A$4.3 million and A$19.7 million
respectively.
The half year report takes into account the completion on December 30, 2005 of our acquisition
of CDS which is described above.
Our Address and Phone Number
Our principal offices are located at Level 12 BGC Centre, 28 The Esplanade, Perth WA 6000,
Australia, and our telephone number is: + 61 (8) 9226 5099. Our website address is
www.psivida.com. We do not incorporate the information on, or accessible through, our website into
this prospectus, and you should not consider it part of this prospectus.
-5-
RISK FACTORS
In considering whether to invest in our ADSs, you should carefully read and consider the risks
described below, together with all of the information we have included in this prospectus.
Risks related to our company and our business
Most of our products and planned products are based upon new and unproven technologies .
We are currently developing products based upon BioSilicon, a biocompatible and biodegradable
form of the element silicon, for multiple applications across many sectors of healthcare, including
controlled slow release drug delivery, diagnostics, orthopedics and tissue engineering.
BioSilicon is a new and unproven technology. The successful development and market acceptance of
BioSilicon is subject to many risks. These risks include the potential for ineffectiveness, lack
of safety, unreliability, failure to receive necessary regulatory clearances or approvals and the
emergence of superior or equivalent products, as well as the effect of changes in future general
economic conditions. Our failure to develop products based on BioSilicon that overcome these risks
would have a material adverse effect on our business, financial condition and results of
operations.
We have recently acquired CDS (now renamed pSivida Inc.), which develops drug delivery
products based upon its proprietary AEON and CODRUG drug delivery systems. To date pSivida Inc.
has developed two such products, Vitrasert and Retisert, which have been approved by the FDA for
treatment of two sight-threatening eye diseases. However, these technologies may prove useful in
other products which would be subject to many of the same risks as described above for BioSilicon.
We have a history of losses; we expect to continue to incur losses; and we may never become
profitable.
pSivida was formed in 2000. As primarily a research and development company, we have incurred
operating losses in every year of existence. Under Australian Equivalents to International
Financial Reporting Standards, or A-IFRS (effective from July 1, 2005), we incurred a net loss of
A$10.7 million for the six months ended December 31, 2005 and under accounting principles generally
accepted in Australia, or A-GAAP, we incurred a net loss of A$14.7 million, A$3.7 million and A$2.8
million for the years ended June 30, 2005, 2004 and 2003, respectively. As of December 31, 2005, we
had an accumulated deficit under A-IFRS of A$39.5 million. We have not achieved profitability and
expect to continue to incur net losses through at least 2007, and we may incur losses beyond that
time, particularly if we are not successful in having BrachySil approved and widely marketed by
that time. Even if BrachySil is approved and is being marketed at some point in 2007 or beyond, we
may not achieve sufficient sales of BrachySil or any other product to become profitable at that
time or at any other time. The extent of future losses and whether or how long it may take for us
to achieve profitability are uncertain.
We recently acquired CDS which has incurred net losses in each of its last five fiscal years.
As a result of the acquisition, we expect to receive royalties from sales of Vitrasert, CDS first
commercial product. However, such sales have declined in each of the past four years and we do not
expect that they will comprise a significant portion of our future revenue. We also expect to
receive royalties from future sales of Retisert, but we are unable to predict the amount of such
future royalties.
We rely heavily upon patents, trade secrets and other proprietary technologies and any future
claims that our rights to such intellectual property are invalid or limited could seriously harm
our business.
Protection of intellectual property rights is crucial to our business, since that is how we
keep others from copying the innovations which are central to our existing and future products.
Our success is dependent on whether we can obtain patents, defend our existing patents and operate
without infringing on the proprietary rights of third parties. We currently have 36 patents and
over 90 pending patent applications, including patents and pending applications covering BioSilicon
and various uses thereof. This does not include the patents and patent applications we acquired in
the acquisition of CDS. We expect to aggressively patent and protect our proprietary technologies.
However, we cannot be sure that any additional patents will be issued to us as a result of our
pending or future patent applications or that any of our patents will withstand challenges by
others. If we were determined to be infringing any third party patent, we could be required to pay
damages, alter our products or processes, obtain licenses or cease certain operations. We may not
be able to obtain any required licenses on commercially favorable terms, if at all. Our failure to
obtain a license for any technology that we may require to commercialize BioSilicon or
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our ophthalmic drug delivery products could have a material adverse effect on our business,
financial condition and results of operations. In addition, many of the laws of foreign countries
in which we intend to operate may treat the protection of proprietary rights differently from, and
may not protect our proprietary rights to the same extent as, laws in Australia, the United States
and Patent Co-operation Treaty countries.
Prior art may reduce the scope or protection of, or invalidate, patents. Previously conducted
research or published discoveries may prevent patents from being granted, invalidate issued patents
or narrow the scope of any protection obtained. Reduction in scope of protection or invalidation
of our licensed or owned patents, or our inability to obtain patents, may enable other companies to
develop products that compete with our products and product candidates on the basis of the same or
similar technology. As a result, our patents and those of our licensors may not provide any or
sufficient protection against competitors.
While we have not been and we are not currently involved in any litigation over intellectual
property, such litigation may be necessary to enforce any patents issued or licensed to us or to
determine the scope and validity of third party proprietary rights. We may also be sued by a third
party alleging that we infringe its intellectual property rights. Any intellectual property
litigation would be likely to result in substantial costs to us and diversion of our efforts. If
our competitors claim technology also claimed by us and if they prepare and file patent
applications in the U.S., we may have to participate in interference proceedings declared by the
U.S. Patent and Trademark office to determine priority of invention, which could result in
substantial cost to us and diversion of our efforts. Any such litigation or interference
proceedings, regardless of the outcome, could be expensive and time consuming. Litigation could
subject us to significant liabilities to third parties, requiring disputed rights to be licensed
from third parties or require us to cease using certain technologies and, consequently, could have
a material adverse effect on our business, financial condition and results of operations.
We also rely on trade secrets, know-how and technology that are not protected by patents to
maintain our competitive position. We try to protect this information by entering into
confidentiality agreements with parties that have access to it, such as our corporate partners,
collaborators, employees, and consultants. Any of these parties could breach these agreements and
disclose our confidential information, or our competitors might learn of the information in some
other way. If any material trade secret, know-how or other technology not protected by a patent
were to be disclosed to or independently developed by a competitor, our competitive position could
be materially harmed.
We rely, in part, on confidentiality agreements with employees, advisors, vendors and
consultants to protect our proprietary expertise. These agreements may be breached and we may not
have adequate remedies in the event of a breach. In addition, our un-patented proprietary
technological expertise may otherwise become known or independently discovered by competitors.
Our ability to commercialize our products depends on our ability to achieve regulatory approvals.
Our current and future activities are and will be subject to regulation by governmental
authorities in the U.S., Europe, Singapore and other countries. Before we can manufacture, market
and sell any of our products, we must first obtain approval from the FDA and/or foreign regulatory
authorities. In order to obtain these approvals, pre-clinical studies and clinical trials must
demonstrate that each of our products is safe for human use and effective for its targeted disease.
Our proposed products are in various stages of pre-clinical and clinical testing. If clinical
trials for any of these products are not successful, that product cannot be manufactured and sold
and will not generate revenue from sales. Clinical trials for our product candidates may fail or
be delayed by many factors, including the following:
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inability to attract clinical investigators for trials; |
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inability to recruit patients in sufficient numbers or at the expected rate; |
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adverse side effects; |
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failure of the trials to demonstrate a products safety or efficacy; |
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failure to meet FDA requirements for clinical trial design or for demonstrating
efficacy for a particular product; |
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inability to follow patients adequately after treatment; |
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changes in the design or manufacture of a product; |
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inability to manufacture sufficient quantities of materials for use in clinical trials; and |
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governmental or regulatory delays. |
Results from pre-clinical testing and early clinical trials often do not accurately predict
results of later clinical trials. Data obtained from pre-clinical and clinical activities are
susceptible to varying interpretations which may delay, limit or prevent regulatory approval. Data
from pre-clinical studies, early clinical trials and interim periods in multi-year trials are
preliminary and may change, and final data from pivotal trials for such products may differ
significantly. Adverse side effects may develop that delay, limit or prevent the regulatory
approval of products, or cause their regulatory approvals to be limited or even rescinded.
Additional trials necessary for approval may not be undertaken or may ultimately fail to establish
the safety and efficacy of proposed products. The FDA may not approve proposed products for
manufacture and sale.
In addition to testing, the FDA imposes various requirements on manufacturers and sellers of
products under its jurisdiction, such as labeling, manufacturing practices, record keeping and
reporting requirements. The FDA also may require post-marketing testing and surveillance programs
to monitor a products effects. Furthermore, changes in existing regulations or the adoption of
new regulations could prevent us from obtaining, or affect the timing of, future regulatory
approvals.
At present Vitrasert and Retisert are our only products that have been approved for sale in
the U.S. for specific purposes. BrachySil and other product candidates utilizing BioSilicon have
not been approved and their approval in the future remains uncertain. In addition, the FDA may
determine to regulate it as a drug, in which case we would incur significant additional cost and
time in order to achieve the required regulatory approvals. Any product approvals we achieve could
also be withdrawn for failure to comply with regulatory standards or due to unforeseen problems
after the products marketing approval.
We have a limited ability to market our products ourselves, and if we are unable to find marketing
partners, or our marketing partners do not successfully market our products then our business will
suffer.
We presently have no marketing or sales staff. Achieving market acceptance for the use of
BioSilicon and other products (including drug delivery products originated by CDS) will require
extensive and substantial efforts by experienced personnel as well as expenditure of significant
funds. We may not be able to establish sufficient capabilities necessary to achieve market
penetration.
We intend to license and/or sell BioSilicon and our other products to companies who will be
responsible in large part for sales, marketing and distribution of products utilizing BioSilicon
and our other products. The amount and timing of resources which may be devoted to the performance
of their contractual responsibilities by these licensees are not expected to be within our control.
These partners may not perform their obligations.
Moreover, our licensees may have rights of termination under our agreements with them.
Exercise of termination rights by those parties may leave us temporarily or permanently without any
marketing or sales resources which may have an adverse effect on our business, financial condition
and results of operations. Additionally, our interests may not continue to coincide with those of
our partners, and our partners may develop independently or with third parties products or
technologies which could compete with our products. Further, disagreements over rights or
technologies or other proprietary interests may occur.
pSivida Inc., formerly CDS, has exclusively licensed its technology with respect to Vitrasert,
Retisert and certain other ophthalmic uses to Bausch & Lomb, and with respect to Medidur for
diabetic macular edema, or DME and certain other ophthalmic uses to Alimera Sciences. Bausch &
Lomb is responsible for funding and managing the development and commercialization of all products
under its agreement with pSivida Inc. and can terminate the agreement at any time upon 90 days
written notice. Alimera Sciences and pSivida Inc. are jointly funding the development of products
licensed under that agreement, and Alimera Sciences may terminate its agreement with pSivida Inc.
if pSivida Inc. fails to make a development payment or may terminate the agreement with respect to
a particular product if pSivida Inc. notifies Alimera that it has abandoned the product or upon 30
days notice following pSivida Inc.s failure to make development payments exceeding US$2 million
for that product. Either
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Bausch & Lomb or Alimera Sciences may decide not to continue with or commercialize any or all
of the licensed products, change strategic focus, pursue alternative technologies, develop
competing products or terminate their agreements with pSivida Inc. While Bausch & Lomb has
significant experience in the ophthalmic field and substantial resources, there is no assurance as
to whether and the extent to which that experience and those resources will be devoted to pSivida
Inc.s technologies. Alimera Sciences was only incorporated in June 2003 and has limited
resources. Because we do not currently have sufficient funding or internal capabilities to develop
and commercialize these products and proposed products, decisions, actions, breach or termination
of these agreements by Bausch & Lomb or Alimera Sciences could delay or stop the development or
commercialization of Retisert, Medidur for DME or other of our products licensed to such entities.
Our business strategy includes entering into collaborative agreements for the development and
commercialization of our product candidates. The curtailment or termination of any of these
agreements could adversely affect our business and our ability to develop and commercialize our
products and proposed products and fund our operations.
The success of these and future collaboration agreements will depend heavily on the
experience, resources efforts and activities of our collaborators. Our collaborators have and are
expected to have significant discretion in making these decisions. Risks that we face in
connection with our collaboration strategy include:
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collaboration agreements are, and are expected to be, subject to termination under
various circumstances, including, in some cases, on short notice and without cause; |
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we are required, and expect to be required, under our collaboration agreements not
to conduct specified types of research and development in the field that is the subject
of the collaboration. These agreements may have the effect of limiting the areas of
research and development that we can pursue; |
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our collaborators may develop and commercialize, either alone or with others,
products that are similar to or competitive with our products; |
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our collaborators may change the focus of their development and commercialization
efforts. Pharmaceutical and biotechnology companies have historically re-evaluated and
changed their priorities for many reasons. The ability of our products to reach their
potential could be limited if our collaborators decrease or fail to increase spending
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our collaborators may lack the funding or experience to develop and commercialize
our products successfully or may otherwise fail to do so. |
To the extent that we choose not to or we are unable to enter into future license agreements
with marketing and sales partners, we may experience increased capital requirements to develop the
ability to market and sell future products. We may not be able to market or sell our technology or
future products independently in the absence of such agreements.
Our markets are competitive and our competitors could develop more effective products, making our
products less competitive, uneconomical or obsolete, thereby impacting our future operations.
We are or plan to be engaged in the rapidly evolving and competitive fields of drug delivery,
tissue engineering, diagnostics and orthopedics technologies. Our competitors include many major
pharmaceutical companies and other biotechnology, drug delivery, diagnostics and medical products
companies.
Many of our potential competitors have substantially greater financial, technological,
research and development, marketing and personnel resources. Our competitors may succeed in
developing alternate technologies and products that are more effective, easier to use, more
economical than those which we have developed or that would render our technologies and products
obsolete and non-competitive in these fields. These competitors may also have greater experience
in developing products, conducting clinical trials, obtaining regulatory approvals or clearances
and manufacturing and marketing such products or technologies.
We believe that pharmaceutical, drug delivery and biotechnology companies, research
organizations, governmental entities, universities, hospitals, other nonprofit organizations and
individual scientists are seeking to develop the drugs, therapies, products, approaches or methods
to treat our targeted diseases or their underlying
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causes. For many of our targeted diseases, competitors have alternate therapies that are
already commercialized or are in various stages of development ranging from discovery to advanced
clinical trials. Any of these drugs, therapies, products, approaches or methods may receive
government approval or gain market acceptance more rapidly than our products and proposed products,
may offer therapeutic or cost advantages or may cure our targeted diseases or their underlying
causes completely, which could reduce demand for our products and proposed products and could
render them noncompetitive or obsolete. For example, sales of pSivida Inc.s Vitrasert product for
the treatment of CMV retinitis, a disease which affects people with late-stage AIDS, have declined
significantly, because of new treatments that delay the onset of late-stage AIDS.
Our competitive position is based upon our ability to:
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create and maintain scientifically-advanced technology and proprietary products and processes; |
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attract and retain qualified personnel; |
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develop safe and efficacious products, alone or in collaboration with others; |
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obtain patent or other protection for our products and processes; |
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obtain required government approvals on a timely basis; |
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manufacture products on a cost-effective basis; and |
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successfully market products. |
If we are not successful in meeting these goals, our business could be adversely affected.
We face risks in expanding our efforts beyond our core area of experience and expertise.
We plan to expand our focus outside of our initial areas of experience and expertise to seek
to broaden our product pipeline and will require additional internal expertise or external
collaborations in areas in which we currently do not have internal resources and expertise. Such
expertise and collaborations may be difficult to obtain. We are currently focused on targeted
controlled drug delivery with a specialty, through pSivida Inc., on ophthalmic drug delivery and,
through pSiMedica and pSiOncology, on brachytherapy and other controlled delivery mechanisms
utilizing BioSilicon. We have begun to expand our focus into diagnostics (through AION
Diagnostics) and the food industry (through pSiNutria) and plan to expand into other areas at a
later time. In connection with the foregoing, we may have to enter into collaboration arrangements
with others that may require us to relinquish rights to certain of our technologies or products
that we would otherwise pursue independently. We may be unable to acquire the necessary expertise
or enter into collaboration agreements on acceptable terms.
Problems associated with international business operations could affect our ability to manufacture
and sell our products.
We currently maintain offices in Australia, the UK, Singapore and (following our acquisition
of CDS) the U.S.; BioSilicon is produced for us in Germany and the UK; we are conducting product
trials in Singapore; we have research and development facilities in the UK and the U.S.; and we
intend to license and/or sell products in most major world healthcare markets. A number of risks
are inherent in our international strategy. In order for us to license and manufacture our
products, we must obtain country-specific regulatory approvals or clearances or comply with
regulations regarding safety and quality in a variety of jurisdictions. We may not be able to
obtain or maintain regulatory approvals or clearances in such countries and we may be required to
incur significant costs in obtaining or maintaining foreign regulatory approvals or clearances. In
addition, our operations and revenues are subject to a number of risks associated with foreign
commerce, including the following:
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managing foreign distributors; |
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staffing and managing foreign operations; |
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political and economic instability; |
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foreign currency exchange fluctuations; |
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foreign tax laws, tariffs and freight rates and charges; |
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timing and availability of export licenses; |
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inadequate protection of intellectual property rights in some countries; and |
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obtaining required governmental approvals. |
There are risks relating to product manufacturing which could cause delays in product development
and commercialization and impact our future profitability.
Our ability to conduct timely preclinical and clinical research and development programs,
obtain regulatory approvals, commercialize our product candidates and fulfill our contract
manufacturing obligations to others will depend, in part, upon our ability to manufacture our
products, either directly or through third parties, in accordance with U.S. Food and Drug
Administration, or FDA, and other regulatory requirements. We currently have BioSilicon production
capability at our facilities in the UK, which may be augmented where required by QinetiQs UK
production facilities for use in internal and collaborative research. BrachySil is currently
manufactured under contract in accordance with applicable FDA regulations by Hosokawa Micron Group,
Atomising Systems Ltd, HighForce Ltd and AEA Technology QSA GmbH.
If we are unable to manufacture BioSilicon or BrachySil or other product candidates by
ourselves or acquire BioSilicon from QinetiQ or acquire BioSilicon or BrachySil or other product
candidates from third parties, we would be unable to proceed with or could experience delays in
development and commercialization of our proposed products. We may not be able to manufacture our
proposed products successfully or in a cost-effective manner at our own or third party facilities.
If we are unable to develop our own manufacturing facilities or to obtain or retain third-party
manufacturing on acceptable terms, we may not be able to conduct certain future preclinical and
clinical testing or to supply commercial quantities of our products.
Our recently acquired subsidiary pSivida Inc. also has limited manufacturing experience and
has exclusively licensed Bausch & Lomb the rights to manufacture Vitrasert, Retisert and other
products covered by its license agreement with pSivida Inc., and Alimera Sciences, the rights to
manufacture Medidur for DME, if approved for marketing, and other products covered by its license
agreement with pSivida Inc. Our current reliance on third party manufacturers for some of our
products entails risks, including:
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the possibility that third parties may not comply with the FDAs current good
manufacturing practices, regulations, other regulatory requirements, and those of
similar foreign regulatory bodies, and employ adequate quality assurance practices; |
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supply disruption, deterioration in product quality or breach of a manufacturing or
license agreement by the third party because of factors beyond CDS control; |
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the possible termination or non-renewal of a manufacturing or licensing agreement
with a third party at a time that is costly or inconvenient to CDS; and |
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inability to identify or qualify an alternative manufacturer in a timely manner,
even if contractually permitted to do so. |
Fast track status for Medidur may not actually lead to faster development, regulatory review or
approval.
The FDA has granted fast track designation to Medidur for the treatment of DME. Although this
designation makes this product eligible for expedited approval procedures, it does not ensure
faster development, review or approval compared to the conventional FDA procedures. Further, the
FDA may withdraw the fast track designation if it determines that the designation is no longer
supported by emerging data from clinical trials or if it determines that the criteria for the
designation is no longer satisfied.
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Our proposed products will be subject to the uncertainty of third-party reimbursement and health
care reform measures which may limit market acceptance.
In both domestic and foreign markets, our ability to commercialize our products will depend,
in part, upon the availability of reimbursement from third-party payors, such as government health
administration authorities, private health insurers and other organizations. Third-party payors are
increasingly challenging the price and cost-effectiveness of medical products. If our products are
not considered cost-effective, third-party payors may limit reimbursement. Government and other
third-party payors are increasingly attempting to contain healthcare costs by limiting both
coverage and the level of reimbursement for new therapeutic products approved for marketing by the
FDA and by refusing, in some cases, to provide any coverage for uses of approved products for
disease indications for which the FDA has not granted marketing approval. If government and
third-party payors do not provide adequate coverage and reimbursement levels for uses of our
products, the market acceptance of our products would be limited.
There have been a number of U.S. federal and state proposals during the last few years to
subject the pricing of pharmaceuticals to government control and to make other changes to the
health care system of the U.S. It is uncertain what legislative proposals will be adopted or what
actions federal, state or private payors for health care goods and services may take in response to
any health care reform proposals or legislation. We cannot predict the effect health care reforms
may have on our business.
The loss of some or all of our key personnel could harm our business.
We are dependent upon the principal members of our management and scientific staff. In
addition, we believe that our future success in developing BioSilicon and other products and
achieving a competitive position will depend to a large extent on whether we can attract and retain
additional qualified management and scientific personnel. There is strong competition for such
personnel within the industry in which we operate and we may not be able to continue to attract
such personnel either to Malvern in the United Kingdom or to Massachusetts, where our research and
development is conducted. As we do not have large numbers of employees and our products are unique
and highly specialized, the loss of the services of one or more of the senior management or
scientific staff, or the inability to attract and retain additional personnel and develop expertise
as needed, could have a material adverse effect on our results of operations and financial
condition.
We may be subject to product liability suits, and we may not have sufficient insurance to cover
damages.
The testing, manufacturing, and future marketing and sale of the products utilizing BioSilicon
and our other products involves risks that product liability claims may be asserted against us or
our licensees. Our current clinical trial insurance may not be adequate or continue to be
available, and we may be unable to obtain adequate product liability insurance on reasonable
commercial terms, if at all. In the event clinical trial insurance is not adequate, our ability to
continue with planned research and development in the relevant area could be negatively impacted.
We will need additional capital to conduct our operations and develop our products, and our ability
to obtain the necessary funding is uncertain.
We expect to require substantial additional capital resources in order to conduct our
operations and develop our products. The timing and degree of any future capital requirements will
depend on many factors, including:
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the accuracy of the assumptions underlying our estimates for our capital needs
in the near and long term; |
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continued scientific progress in our research and development programs; |
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the magnitude and scope of our research and development programs; |
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our ability to maintain and establish strategic arrangements for research,
development, clinical testing, manufacturing and marketing; |
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our progress with preclinical and clinical trials; |
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the time and costs involved in obtaining regulatory approvals; and |
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the costs involved in preparing, filing, prosecuting, maintaining, defending and
enforcing patent claims. |
If and when it is required, we will attempt to acquire additional funding through strategic
collaborations, public or private equity financings, capital lease transactions or other financing
sources that may be available. Additional financing may not be available on acceptable terms, or at
all. Additional equity financings could result in significant dilution to stockholders. Further, in
the event that additional funds are obtained through arrangements with collaborative partners,
these arrangements may require us to relinquish rights to some of our technologies, product
candidates or products that we would otherwise seek to develop and commercialize ourselves. If
sufficient capital is not available, we may be required to delay, reduce the scope of or eliminate
one or more of our research or development programs, each of which could have a material adverse
effect on our business.
We have experienced rapid growth and changes in our business, and our failure to manage this and
any future growth and changes could harm our business.
As evidenced by our purchase of the remaining shares of pSiMedica on August 4, 2004, the
incorporation and planned spin-off of AION Diagnostics, the incorporation of pSiNutria Limited and
our acquisition of CDS on December 30, 2005, our business is rapidly changing. See Risks related
to our recent acquisition of CDS and other recent transactions.
We expect to continue increasing the number of our employees, and we may suffer if we do not
manage and train our new employees effectively. Further, our efforts span various geographies.
Continued rapid growth and operation in multiple locations may place significant strains on our
managerial, financial and other resources. The rate of any future expansion, in combination with
our complex technologies and products, may demand a level of managerial effectiveness in
anticipating, planning, coordinating and meeting our operational needs which we may not be able to
successfully provide.
In addition, if we make additional acquisitions or divestitures, we could encounter
difficulties that harm our business. We may acquire companies, products or technologies that we
believe to be complementary to our business. If we do so, we may have difficulty integrating the
acquired personnel, operations, products or technologies. In addition, acquisitions may distract
our management and employees and increase our expenses, which could harm our business. We may also
sell businesses or assets as part of our strategy or if we receive offers from third parties. If we
do so, we may sell an asset or business for less than its full value or may lose valuable
opportunities attendant to such asset or business.
If we fail to comply with environmental laws and regulations, our ability to manufacture and
commercialize products may be adversely affected.
Medical and biopharmaceutical research and development involves the controlled use of
hazardous materials, such as radioactive compounds and chemical solvents. We are subject to
federal, state and local laws and regulations in the U.S. and abroad governing the use,
manufacture, storage, handling and disposal of such materials and waste products. We could be
subject to both criminal liability and civil damages in the event of an improper or unauthorized
release of, or exposure of individuals to, hazardous materials. In addition, claimants may sue us
for injury or contamination that results from our use or the use by third parties of these
materials, and our liability may exceed our total assets. Compliance with environmental laws and
regulations is expensive, and current or future environmental regulations may impair our research,
development or production efforts or harm our operating results.
Risks
related to our being headquartered and incorporated outside of the
United States
You may have difficulty in effecting service of legal process and enforcement of judgments against
us or our management.
We are a public company limited by shares, registered and operating under the Australian
Corporations Act 2001. Several of our directors and most of our officers reside outside the U.S.
Substantially all or a substantial portion of the assets of those persons are located outside the
U.S. As a result, it may not be possible to effect service on such persons in the U.S. or to
enforce, in foreign courts, judgments against such persons obtained in U.S. courts and predicated
on the civil liability provisions of the federal securities laws of the U.S. Furthermore, a large
percentage of our directly owned assets are located outside the U.S., and, as such, any judgment
obtained in the U.S. against pSivida may not be collectible within the U.S. There is doubt as to
the enforceability in the Commonwealth
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of Australia, in original actions or in actions for enforcement of judgments of U.S. courts,
of civil liabilities predicated solely upon federal or state securities laws of the U.S.,
especially in the case of enforcement of judgments of U.S. courts where the defendant has not been
properly served in Australia.
As a foreign private issuer we do not have to provide you with the same information as an issuer of
securities based in the U.S.
Because we are a foreign private issuer within the meaning of the rules under the Exchange
Act, we are exempt from certain provisions of that law that are applicable to U.S. public
companies, including (i) the rules under the Exchange Act requiring the filing with the SEC of
quarterly reports on Form 10-Q or current reports on Form 8-K; (ii) the sections of the Exchange
Act regulating the solicitation of proxies, consents or authorizations in respect of a registered
security; and (iii) the sections of the Exchange Act requiring insiders to file public reports of
their stock ownership and trading activities and liability for insiders who profit from trades made
in a short period of time. Thus, you are not afforded the same protections or information which
would be made available to you were you investing in a U.S. public corporation.
In accordance with the requirements of the Australian Stock Exchange, we disclose annual and
semi-annual results. Our results are presented in accordance with A-GAAP. Effective July 1, 2005,
our results are presented in accordance with A-IFRS. Our annual results reported in the U.S. with
the SEC include a reconciliation to accounting principles generally accepted in the United States
of America, or US GAAP. Based on our evaluation of the effectiveness of the design and operation
of our disclosure controls and procedures, as defined in Rule 13a-15(e) and Rule 15d-15(e) of the
Securities Exchange Act of 1934, we have concluded that, as of June 30, 2005 our disclosure
controls and procedures were ineffective in that we had insufficient accounting personnel who have
sufficient knowledge and experience in US GAAP and the U.S. SEC accounting requirements.
Our annual results are audited, and our semi-annual results undergo a limited review by our
independent auditors. Subject to certain exceptions, we are also required to immediately disclose
to the Australian Stock Exchange any information concerning us that a reasonable person would
expect to have a material effect on the price or value of our shares. This would include matters
such as (i) any major new developments relating to our business which are not public knowledge and
may lead to a substantial movement in our share price; (ii) any changes in our board of directors;
(iii) any purchase or redemption by pSivida of its own equity securities; (iv) interests of
directors in our shares or debentures; and (v) changes in our capital structure. We are required to
provide our semi-annual results and other material information that we disclose in Australia in the
U.S. under the cover of Form 6-K. Nevertheless, this information is not the same and may not be as
much information as would be made available to you were you investing in a U.S. public corporation.
Risks
related to our stock and our ADSs
If we are a passive foreign investment company, holders of our shares and ADSs may suffer adverse
tax consequences.
U.S. holders of our ADSs can experience unfavorable tax consequences if we are treated as a
passive foreign investment company, or PFIC, under the U.S. Internal Revenue Code of 1986, as
amended, for any year during which the U.S. holder owns our ADSs. For example, if a U.S. holder
disposes of an ADS at a gain, and during any year of its holding period we were a PFIC, then such
gain would be taxable as ordinary income and not as capital gain and would be subject to additional
taxation based on the length of time the U.S. holder held such stock. Most of the tax
consequences of our being a PFIC can be mitigated if the U.S. holder makes certain elections as
described in our Annual Report on Form 20-F for the fiscal year ended June 30, 2005, filed with the
SEC on January 18, 2006 in Item 10.E under U.S. Federal Income Tax Considerations.
In general, we will be a PFIC for any taxable year if either (1) 75% or more of our gross
income in the taxable year is passive income, or (2) 50% or more of the average value of our assets
in the taxable year produces, or is held for the production of, passive income. We do not yet know
whether we will be classified as a PFIC in the year ending June 30, 2006 or thereafter. Most of
the tax consequences of pSivida being a PFIC can be mitigated if the U.S. holder makes certain
mitigating elections as described in Item 10.E of our Annual Report. In the event we are
classified as a PFIC, we intend to provide U.S. holders with sufficient information to enable them
to make a mitigating election if so desired. However, we may fail to provide such information, and
if we do, you may not be aware of our status as a PFIC and may be subject to additional taxes and
penalties.
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Holders of ADSs may have limited rights relative to holders of our Ordinary Shares in certain
circumstances.
The rights of holders of ADSs with respect to voting of ordinary shares and the right to
receive certain distributions may be limited in certain respects by the deposit agreement entered
into by us and Citibank, N.A. For example, although ADS holders are entitled under the deposit
agreement, subject to any applicable provisions of Australian law and of our constitution, to
instruct the depositary as to the exercise of the voting rights pertaining to the ordinary shares
represented by the American Depositary Shares, and the depositary has agreed that it will vote the
ordinary shares so represented in accordance with such instructions, ADS holders may not receive
notices sent by depositary in time to ensure that the depositary will vote the ordinary shares.
This means that holders of ADSs may not be able to exercise their right to vote. In addition, under
the deposit agreement, the depositary has the right to restrict distributions to holders of the
ADSs in the event that it is unlawful or impractical to make such distributions. We have no
obligation to take any action to permit distributions to holders of our American Depositary
Receipts, or ADRs. As a result, holders of ADRs may not receive distributions made by us.
Our stock price is volatile and can fluctuate significantly based on events both within and outside
our control; our trading volume may affect the liquidity of our ADSs.
Since December 2000, the price of our ordinary shares has ranged from A$0.09 to A$1.44 per
share, and since January 27, 2005, the price of our ADSs has ranged from US$4.15 to US$12.14. The
price of our ordinary shares and ADSs may be affected by developments directly affecting our
business and by developments out of our control or unrelated to pSivida. The biotechnology sector
in particular and the stock market generally are vulnerable to abrupt changes in investor
sentiment. Prices of securities and trading volume of companies in the biotechnology industry,
including ours, can swing dramatically in ways unrelated or that bear a disproportionate
relationship to operating performance. Our share and ADS prices and their trading volume may
fluctuate based on a number of factors including, but not limited to:
|
|
|
clinical trial results and other product and technological developments and
innovations; |
|
|
|
|
FDA and other governmental regulatory actions, receipt and timing of approvals
of our proposed products, and any denials and withdrawals of approvals; |
|
|
|
|
competitive factors including new product ideas and technologies, clinical trial
results and approvals of competitive products in our markets; |
|
|
|
|
advancements with respect to treatment of the diseases targeted by our proposed
products; |
|
|
|
|
developments relating to collaborative partners including execution and
termination of agreements, achievement of milestones and receipt of payments; |
|
|
|
|
availability and cost of capital and our financial and operating results; |
|
|
|
|
changes in reimbursement policies or other practices related to our proposed
products or the pharmaceutical industry generally; |
|
|
|
|
meeting, exceeding or failing to meet analysts or investors expectations, and
changes in evaluations and recommendations by securities analysts; |
|
|
|
|
economic, industry and market conditions, changes or trends; and |
|
|
|
|
other factors unrelated to us and the biotechnology industry. |
In addition, low trading volume may increase the volatility of the price of our ADSs. Trading
volume in our ordinary shares on other markets has not been historically high, and trading volume
of our ADSs on the NASDAQ National Market has also been low. Further, because each of our ADSs
represents ten of our ordinary shares, trading volume in our ADSs may be lower than that for our
ordinary shares. A thin trading market could cause the price of our ADSs to fluctuate
significantly more than the stock market as a whole. For example, trades involving a relatively
small number of our ADSs may have a greater impact on the trading price for our ADSs than
-15-
would be the case if their trading volume were higher. Accordingly, holders of our ADSs may
not be able to liquidate a position in our ADSs in the desired time or at the desired price.
The fact that we do not expect to pay cash dividends may lead to decreased prices for our stock.
We have never paid a cash dividend on our Ordinary Shares and we do not anticipate paying any
cash dividend. We intend to retain future cash earnings, if any, for reinvestment in the
development and expansion of our business. Our convertible note agreement limits our ability to
pay dividends.
Future issuances and sales of our stock could dilute your ownership and cause our stock price to
decline.
As of December 31, 2005, we have outstanding options to purchase 31,169,162 of our ordinary
shares, representing 8.1% of the total outstanding ordinary shares. In 2005, we raised capital
through the issuance of 665,000 ADSs and warrants to acquire 133,000 ADSs and issued a convertible
note currently convertible into 2,112,676 ADSs together with warrants to acquire an additional
633,803 ADSs. In addition, under certain circumstances, the convertible note will become
convertible into a larger number of ADSs and the accrued interest on the principal amount of the
note may be converted, in either case, potentially resulting in the issuance of a substantially
larger number of ADSs. We issued a further 150,820,380 ordinary shares (represented by 15,082,038
ADSs) in exchange for the outstanding CDS common and preferred shares on the date of the
acquisition in accordance with the merger agreement, 1,211,180 nonvested ordinary shares
(represented by 121,118 nonvested ADSs) in connection with employee retention agreements and
9,016,230 nonvested ordinary shares (represented by 901,623 nonvested ADSs) in exchange for the
shares of nonvested CDS common stock outstanding on the date of the acquisition in accordance with
retention agreements between CDS and its officers and employees. Exercise and conversion of these
options, warrants and convertible securities would dilute existing shareholders. Further, we intend
to continue to finance our operations through the issuance of equity securities, if feasible.
Certain of our shareholders own a significant percentage of our ordinary shares and therefore may
be able to influence our business in ways that are less beneficial to you.
Our executive officers, directors (including the officers and directors of our subsidiaries)
and their affiliates beneficially own or control approximately 15.20% of our outstanding ordinary
shares (based on the number of our ordinary shares outstanding on December 31, 2005 and assuming
the issuance of shares upon the exercise of options vested or vesting within 60 days of December
31, 2005). As a result, if our executive officers and directors and their affiliates were all to
vote in the same way, they would have the ability to exert significant influence over our board of
directors and how we operate our business. The concentration of ownership may also have the effect
of delaying, deferring or preventing a change in control of our company.
If we fail to comply with internal controls evaluations and attestation requirements our stock
price could be adversely affected.
We are subject to United States securities laws, including the Sarbanes-Oxley Act of 2002 and
the rules and regulations adopted by the U.S. Securities and Exchange Commission, or SEC, pursuant
to such Act. Under Section 404 of the Sarbanes-Oxley Act and the related regulations, we are
required to perform an evaluation of our internal controls over financial reporting and have our
independent registered public accounting firm publicly attest to this evaluation beginning in the
year ending June 30, 2007. We will shortly commence the evaluation and expect to complete it in
the first quarter of 2007. We expect internal control evaluations and attestation requirements to
be time-consuming and expensive. If we fail to complete the evaluation of our internal controls
over financial reporting in time, if we identify material weaknesses in these internal controls or
if our independent accountant does not timely attest to our evaluation, we could be subject to
regulatory scrutiny and decreased public confidence in our internal controls, which may adversely
affect the market price of our stock.
Risks related to our recent acquisition of CDS and other recent transactions
The following risk factors relate to our December 30, 2005 acquisition of CDS, as well as two
recently completed transactions: (1) our US$4.3 million private placement structured as a private
investment in public equity, referred to herein as the PIPE, and (2) our US$15 million convertible
note financing, referred to herein as the convertible note financing. For a description of the CDS
acquisition, the PIPE and the convertible note financing, see Item 8B, Significant Changes.
-16-
We may fail to integrate our operations successfully with the operations of CDS. As a result,
pSivida and CDS may not achieve the anticipated benefits of the merger, which could adversely
affect the price of ADSs.
We entered into the merger agreement and consummated the merger with the expectation that the
merger will result in benefits to the combined companies, including the opportunities to combine
the two companies technologies, products and product candidates and the opportunity for pSivida to
establish a substantial presence in the U.S. which would facilitate access to U.S. markets.
However, these expected benefits may not be fully realized. Failure of the combined company to meet
the challenges involved with successfully integrating the personnel, products, technology and
research and development operations of the two companies following the merger or to realize any of
the other anticipated benefits of the merger, could have a material adverse effect on our business,
financial condition and results of operations as well as on that of our subsidiaries, including CDS
(now pSivida Inc.). These integration efforts may be difficult and time consuming, especially
considering the highly technical and complex nature of each companys products. The challenges
involved in this integration include the following:
|
|
|
coordinating research and development operations in a rapid and efficient manner; |
|
|
|
|
combining platform technologies of disparate sources; |
|
|
|
|
demonstrating to collaboration partners that the merger will not result in adverse
changes in technology focus or development standards; |
|
|
|
|
retaining key alliances with collaboration partners; |
|
|
|
|
absorbing costs and delays in implementing overlapping systems and procedures,
including financial accounting systems and accounting principles; |
|
|
|
|
persuading employees that our business culture and that of CDS are compatible,
maintaining employee morale and retaining key employees; and |
|
|
|
|
overcoming potential distraction of management attention and resources from the
business of the combined company. |
We may not successfully integrate our operations and technology with those of CDS in a timely
manner, or at all. We may not realize the anticipated benefits of the merger to the extent, or in
the timeframe, anticipated, which could significantly harm our business.
Our operating results could be adversely affected as a result of purchase accounting treatment, and
the corresponding impact of amortization or impairment of other intangibles relating to the merger,
if the results of the combined company do not offset these additional expenses.
Under A-IFRS (effective from July 1, 2005), we accounted for the merger with CDS using the
purchase method of accounting. Under purchase accounting, we recorded the market value of our ADSs,
cash, and other consideration issued in connection with the merger and the amount of direct
transaction costs as the cost of acquiring the business of CDS. We allocated that cost to the
individual assets acquired and liabilities assumed, including identifiable intangible assets, based
on their respective estimated fair values. Intangible assets are being amortized over a 12 year
period on a straight line basis. Based on our preliminary allocation of the purchase price, which
is subject to change based on the actual outcome of a third party independent valuation, the amount
allocated to goodwill is approximately A$29.7 million, the amount allocated to identifiable
intangible assets is approximately A$120.0 million, giving rise to a gross deferred tax liability
of approximately A$48.0 million (approximately A$27.3 million net of deferred tax assets). Goodwill
is not subject to amortization but is subject to at least an annual impairment analysis, which may
result in an impairment charge if the carrying value of the cash-generating unit to which goodwill
has been allocated exceeds its recoverable value. If identifiable intangible assets were amortized
in equal quarterly amounts over a 12 year period following completion of the merger, the
amortization attributable to these items would be approximately A$2.5 million per quarter and
A$10.0 million per fiscal year. As a result, purchase accounting treatment of the merger could
increase our net loss or decrease our net income in the foreseeable future, which could have a
material and adverse effect on the future market value of our ADSs.
-17-
We have incurred significant costs in connection with the merger.
We incurred direct transaction costs of approximately US$3.8 million (approximately A$5.2
million) associated with the merger, which are included as a part of the total purchase
consideration for accounting purposes. In addition, prior to completing the merger, CDS incurred
direct transaction costs for accounting, investment banking and legal services of approximately
US$2.4 million (approximately A$3.3 million), which are to be expensed in the period in which they
are incurred. We believe the combined entity may incur charges to operations, which currently are
not reasonably estimable, in the quarter in which the merger was completed or the following
quarters, to reflect costs associated with integrating the two companies and that such charges may
be material.
Regulatory agencies, private parties, state attorneys general and other antitrust authorities may
raise challenges to the merger on antitrust grounds.
We believe that the merger could be completed without making any filings with the Federal
Trade Commission, or FTC, the Antitrust Division of the U.S. Department of Justice, or the
Antitrust Division, or any other governmental authority whether under the Hart-Scott-Rodino
Antitrust Improvements Act of 1976, as amended, or the HSR Act, or otherwise and without waiting
for the expiration of any waiting period requirements. However, the FTC and the Antitrust Division
frequently scrutinize the legality under the antitrust laws of transactions like the merger, and at
any time after the completion of the merger, the FTC or the Antitrust Division could take any
action under the antitrust laws as it deems necessary or desirable in the public interest,
including seeking the divestiture of our substantial assets or those of CDS. In addition, certain
private parties, as well as state attorneys general and other antitrust authorities, may challenge
the transaction under antitrust laws under certain circumstances.
In addition, the merger may be subject to the antitrust laws of Australia or other foreign
jurisdictions. Anti-competitive mergers or acquisitions in Australia are regulated under sections
50 and 50A of the Commonwealth Trade Practices Act, or TPA, which generally prohibits any
acquisition of shares or assets which is likely to have the effect of substantially lessening
competition in a market in Australia. The Australian antitrust regulator, the Australian
Competition and Consumer Commission, or ACCC, may on its own initiative apply to an Australian
Court under that law in order to block a merger, or to obtain orders for the divestiture of assets,
or for other remedies. A private party may also apply to an Australian Court under that law for a
more limited range of remedies.
There can be no assurance that a challenge to the merger on antitrust grounds will not be
made, or, if such a challenge is made, what the result will be.
If CDS former stockholders sell substantial amounts of ADSs after the merger, the market price of
ADSs may decline.
The resale by former CDS stockholders of pSivida ADSs after the merger could cause the market
price of our ADSs to decline. In connection with the merger, we have issued 16,104,779 ADSs. While
those ADSs will not initially be freely tradable, we have agreed to register their resale within
six months (subject to certain extensions) for stockholders entering into the registration rights
agreement. Therefore, approximately 16,104,779 pSivida ADSs issued in the merger are expected to
become freely tradable under U.S. securities laws six months from the closing date of the merger
which was December 30, 2005. However, certain shareholders are subject to lock-ups for as long as
9 months after the closing date of the merger.
If the price of our ADSs does not rise above the conversion price by the time payment on the
convertible note becomes due, we may have to repay all or part of the funds received in the
convertible note financing.
On November 16, 2005, we issued a subordinated convertible promissory note in the principal
amount of US$15 million (A$19.7 million) to an institutional investor. The convertible note must
be repaid in full in cash on the third anniversary of its issuance, unless the principal is earlier
converted. In addition, the holder may require payment in cash of up to one-third of the principal
on each of November 16, 2006, May 16, 2007 and November 16, 2007 in the event that the average
trading price of our ADSs does not exceed the then effective conversion price over the ten trading
days leading up to any of those dates. The note is currently convertible at a conversion price of
US$7.10 per ADS, subject to adjustment based on certain events or circumstances, including the
market price of ADSs for the ten trading days ended on August 5, 2006. We may make quarterly
interest payments on the note by issuing ADSs if certain conditions are met including the
effectiveness of a registration statement covering the ADSs, continued listing of our shares or
ADSs, and timely delivery of conversion ADSs during the period preceding the
-18-
payment date, among others. If any of the conditions are not met, we will be required to pay
the interest due in cash. Given the cash needs of our business and our current level of revenue,
we cannot predict whether or not we will be able to meet any of these cash payment obligations or
what impact these obligations might have on our business and operations.
If we fail to register the resale of ADSs by the applicable deadlines, we may be subject to
substantial penalties.
In connection with the acquisition of CDS, the PIPE and the convertible note financing, we
have entered into agreements to register with the SEC the resale of ADSs issued to investors and
CDS stockholders. Our obligation to register ADSs in each of these transactions is subject to a
deadline, which may be extended in certain situations, and our failure to meet this deadline
results in monetary penalties against us.
With respect to the PIPE, we were required to complete the registration no later than February
19, 2006. Beginning on March 19, 2006, we may be subject to monthly cash penalties equal to one
percent of the PIPE purchase price, or US$43,225 (A$59,200), until such registration statement
becomes effective. With respect to the convertible note financing, we are required to complete the
initial registration no later than 180 days from the date of the applicable agreement, which places
the deadline on or about May 15, 2006. Failure to comply with this deadline may result in pSivida
having to pay monthly cash penalties equal to one and one-half percent of the convertible note
purchase price, or US$225,000 (A$308,200), until the registration statement becomes effective.
Further, failure to comply with this deadline by in excess of sixty days may result in an event of
default under the convertible note. With respect to the acquisition of CDS, we are required to
complete the registration no later than 180 days from the closing of the merger, which would be on
or about June 30, 2006. Failure to comply with this deadline may result in pSivida having to pay
monthly cash penalties equal to one percent of the average closing price of the ADSs during the ten
trading days ending on the day that is four trading days prior to the closing of the merger,
multiplied by the number of outstanding unregistered ADSs, until the registration statement becomes
effective. The average trading price of ADSs during the 10-day period just described was US$5.087,
which indicates that such penalties could amount to US$813,089 (A$1,113,700) per month. Each of
these registration deadlines is subject to extension in certain circumstances. Once the
registrations are completed, we are obligated to keep them effective for specified periods, and
failure to do so may subject us to additional penalties.
FORWARD-LOOKING STATEMENTS
The statements incorporated by reference or contained in this prospectus discuss our future
expectations, contain projections of our results of operations or financial condition, and include
other forward-looking information within the meaning of Section 27A of the Securities Act of 1933,
as amended. Our actual results may differ materially from those expressed in forward-looking
statements made or incorporated by reference in this prospectus. Forward-looking statements that
express our beliefs, plans, objectives, assumptions or future events or performance may involve
estimates, assumptions, risks and uncertainties. Therefore, our actual results and performance may
differ materially from those expressed in the forward-looking statements. Forward-looking
statements often, although not always, include words or phrases such as the following: will
likely result, are expected to, will continue, is anticipated, estimate, intends,
plans, projection and outlook.
You should not unduly rely on forward-looking statements contained or incorporated by
reference in this prospectus. Various factors discussed in this prospectus, including, but not
limited to, all the risks discussed in Risk Factors may cause actual results or outcomes to
differ materially from those expressed in forward-looking statements. You should read and
interpret any forward-looking statements together with these risks.
Any forward-looking statement speaks only as of the date on which that statement is made. We
will not update any forward-looking statement to reflect events or circumstances that occur after
the date on which such statement is made.
-19-
CAPITALIZATION AND INDEBTEDNESS
The following table sets forth our capitalization at January 31, 2006 and includes our
acquisition of CDS on December 30, 2005. We have not included an As Adjusted column because we
will receive no proceeds from the sale of ADSs by the selling shareholders.
|
|
|
|
|
|
|
As of |
|
|
|
January 31, 2006 |
|
|
|
Actual |
|
|
|
(In Australian Dollars) |
|
Indebtedness |
|
|
|
|
Short-term debt (unsecured) |
|
|
6,668,445 |
|
Long-term debt (unsecured) |
|
|
11,144,576 |
|
|
|
|
|
Total debt |
|
|
17,813,021 |
|
|
|
|
|
|
Stockholders equity (deficit) |
|
|
|
|
Share capital |
|
|
225,110,700 |
|
Reserves |
|
|
3,878,892 |
|
Deficit accumulated prior to development stage |
|
|
(3,813,181 |
) |
Deficit accumulated during development stage |
|
|
(39,391,837 |
) |
Total stockholders equity |
|
|
185,784,574 |
|
|
|
|
|
Total capitalization and indebtedness in accordance with A-IFRS |
|
|
203,597,595 |
|
|
|
|
|
UNAUDITED PRO FORMA CONSOLIDATED FINANCIAL INFORMATION
On December 30, 2005, we completed the acquisition of 100% of the issued capital of CDS. The
acquisition of CDS has been accounted for under the purchase method of accounting.
The unaudited pro forma consolidated financial statements are prepared in accordance with US
GAAP, and are derived from, and should be read in conjunction with, the historical consolidated
financial statements of pSivida, which are incorporated by reference to our Annual Report on Form
20-F for the fiscal year ended June 30, 2005, filed with the SEC on January 18, 2006 and the
historical consolidated financial statements of CDS which are incorporated by reference to our
Supplemental Disclosure submitted on Form 6-K furnished to the SEC on December 22, 2005. Such
unaudited pro forma consolidated financial statements are presented as if the acquisition of CDS
had occurred on July 1, 2004 for the consolidated statement of operations and June 30, 2005 for the
consolidated statement of financial position. Although pSivida and CDS have different fiscal year
ends, the historical consolidated financial statements of CDS have been adjusted to reflect the
same fiscal year as pSivida.
The adjustments necessary to fairly present the unaudited pro forma consolidated financial
statements have been made based on available information and assumptions that pSividas management
believes are reasonable. The unaudited pro forma consolidated financial statements are for
informational purposes only and do not purport to present what pSividas results would actually
have been had these transactions actually occurred on the dates presented or to project pSividas
results of operations or financial position for any future period. The unaudited pro forma
consolidated financial statements reflect preliminary estimates of the allocation of the purchase
price for the acquisition of CDS that may be adjusted based on the actual outcome of an independent
valuation expected to be finalized during the fourth quarter of the fiscal year ending June 30,
2006.
-20-
PSIVIDA LIMITED AND SUBSIDIARIES
Unaudited Pro Forma Consolidated Statement of Financial Position
As of June 30, 2005
(in Australian dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
pSivida |
|
|
CDS |
|
|
|
|
|
|
|
|
|
|
|
|
|
Historical |
|
|
Historical |
|
|
Pro Forma |
|
|
|
|
|
|
|
|
|
|
(3a) |
|
|
(3b) |
|
|
Adjustments |
|
|
|
|
|
|
Pro Forma |
|
ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
|
12,892,061 |
|
|
|
4,450,442 |
|
|
|
(5,363,466 |
) |
|
|
(3c |
) |
|
|
11,979,037 |
|
Receivables |
|
|
709,418 |
|
|
|
44,766 |
|
|
|
|
|
|
|
|
|
|
|
754,184 |
|
Receivables, related party |
|
|
|
|
|
|
34,647 |
|
|
|
|
|
|
|
|
|
|
|
34,647 |
|
Other |
|
|
322,933 |
|
|
|
137,450 |
|
|
|
|
|
|
|
|
|
|
|
460,383 |
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
13,924,412 |
|
|
|
4,667,305 |
|
|
|
(5,363,466 |
) |
|
|
|
|
|
|
13,228,251 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property, plant and equipment, net |
|
|
3,273,663 |
|
|
|
865,412 |
|
|
|
|
|
|
|
|
|
|
|
4,139,075 |
|
Intangible assets, net |
|
|
61,068,502 |
|
|
|
|
|
|
|
120,000,000 |
|
|
|
(3d |
) |
|
|
181,068,502 |
|
Goodwill |
|
|
21,796,699 |
|
|
|
|
|
|
|
51,445,237 |
|
|
|
(3e |
) |
|
|
73,241,936 |
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
|
100,063,276 |
|
|
|
5,532,717 |
|
|
|
166,081,771 |
|
|
|
|
|
|
|
271,677,764 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS
EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payables |
|
|
1,967,718 |
|
|
|
3,309,413 |
|
|
|
(676,557 |
) |
|
|
(3f |
) |
|
|
4,635,236 |
|
Payables, related party |
|
|
50,102 |
|
|
|
34,662 |
|
|
|
|
|
|
|
|
|
|
|
50,102 |
|
Deferred revenue |
|
|
|
|
|
|
1,864,484 |
|
|
|
|
|
|
|
|
|
|
|
1,864,484 |
|
Provisions |
|
|
29,879 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
29,879 |
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
2,047,699 |
|
|
|
5,208,559 |
|
|
|
(676,557 |
) |
|
|
|
|
|
|
6,579,701 |
|
|
|
|
|
|
|
|
|
|
|
Deferred tax liability, net |
|
|
10,365,240 |
|
|
|
|
|
|
|
29,100,000 |
|
|
|
(3g |
) |
|
|
39,465,240 |
|
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
12,412,939 |
|
|
|
5,208,559 |
|
|
|
28,423,443 |
|
|
|
|
|
|
|
46,044,941 |
|
Commitments and contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A redeemable convertibles
preferred stock |
|
|
|
|
|
|
38,035,845 |
|
|
|
(38,035,845 |
) |
|
|
(3h |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders equity: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock and additional
paid-in capital |
|
|
117,798,149 |
|
|
|
16,362,738 |
|
|
|
124,361,454 |
|
|
|
(3i |
) |
|
|
258,522,341 |
|
Deferred stock based compensation |
|
|
|
|
|
|
(1,213,574 |
) |
|
|
1,213,574 |
) |
|
|
(3j |
) |
|
|
|
|
Accumulated other comprehensive
loss |
|
|
(272,067 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(272,067 |
) |
Deficit accumulated prior to
development stage |
|
|
(3,813,181 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,813,181 |
) |
Deficit accumulated during
development stage |
|
|
(26,062,564 |
) |
|
|
|
|
|
|
(2,741,706 |
) |
|
|
(3k |
) |
|
|
(28,804,270 |
) |
Accumulated deficit |
|
|
|
|
|
|
(52,860,851 |
) |
|
|
52,860,851 |
|
|
|
(3l |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders equity
(deficit) |
|
|
87,650,337 |
|
|
|
(37,711,687 |
) |
|
|
175,694,173 |
|
|
|
|
|
|
|
225,632,823 |
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders equity |
|
|
100,063,276 |
|
|
|
5,532,717 |
|
|
|
166,081,771 |
|
|
|
|
|
|
|
271,677,764 |
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the unaudited pro forma consolidated financial statements.
-21-
PSIVIDA LIMITED AND SUBSIDIARIES
Unaudited Pro Forma Consolidated Statement of Operations
Year Ended June 30, 2005
(in Australian dollars except number of shares)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
pSivida |
|
|
CDS |
|
|
|
|
|
|
|
|
|
|
|
|
|
Historical |
|
|
Historical |
|
|
Pro Forma |
|
|
|
|
|
|
|
|
|
|
|
(3m) |
|
|
(3n) |
|
|
Adjustments |
|
|
|
|
|
|
Pro Forma |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaborative research and development
related party |
|
|
|
|
|
|
8,626,181 |
|
|
|
|
|
|
|
|
|
|
|
8,626,181 |
|
Collaborative research and development
other |
|
|
161,666 |
|
|
|
158,385 |
|
|
|
|
|
|
|
|
|
|
|
320,051 |
|
Royalties related party |
|
|
|
|
|
|
4,142,445 |
|
|
|
|
|
|
|
|
|
|
|
4,142,445 |
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
161,666 |
|
|
|
12,927,011 |
|
|
|
|
|
|
|
|
|
|
|
13,088,677 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization expense |
|
|
(6,207,733 |
) |
|
|
(495,177 |
) |
|
|
(10,000,000 |
) |
|
|
(3o |
) |
|
|
(16,702,910 |
) |
Research and development expense |
|
|
(8,287,930 |
) |
|
|
(2,831,869 |
) |
|
|
(1,536,555 |
) |
|
|
(3p |
) |
|
|
(12,656,354 |
) |
Royalties expense, related party |
|
|
|
|
|
|
(79,479 |
) |
|
|
|
|
|
|
|
|
|
|
(79,479 |
) |
Employee benefits expense |
|
|
(1,165,025 |
) |
|
|
|
|
|
|
(771,528 |
) |
|
|
(3p |
) |
|
|
(1,936,553 |
) |
Foreign currency loss |
|
|
(1,623,484 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,623,484 |
) |
Corporate office expenses |
|
|
(4,130,096 |
) |
|
|
(6,944,035 |
) |
|
|
|
|
|
|
|
|
|
|
(11,074,131 |
) |
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
(21,414,268 |
) |
|
|
(10,350,560 |
) |
|
|
(12,308,083 |
) |
|
|
|
|
|
|
(44,072,911 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
|
(21,252,602 |
) |
|
|
2,576,451 |
|
|
|
(12,308,083 |
) |
|
|
|
|
|
|
(30,984,234 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income (expense), net |
|
|
667,310 |
|
|
|
(213,568 |
) |
|
|
|
|
|
|
|
|
|
|
453,742 |
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income tax benefit |
|
|
(20,585,292 |
) |
|
|
2,362,883 |
|
|
|
(12,308,083 |
) |
|
|
|
|
|
|
(30,530,492 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax benefit |
|
|
3,645,504 |
|
|
|
|
|
|
|
3,978,080 |
|
|
|
(3q |
) |
|
|
7,623,584 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before outside equity
interest |
|
|
(16,939,788 |
) |
|
|
2,362,883 |
|
|
|
(8,330,003 |
) |
|
|
|
|
|
|
(22,906,908 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to outside equity
interest |
|
|
378,276 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
378,276 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
|
(16,561,512 |
) |
|
|
2,362,883 |
|
|
|
(8,330,003 |
) |
|
|
|
|
|
|
(22,528,632 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accretion of redeemable convertible
preferred stock |
|
|
|
|
|
|
(3,246,135 |
) |
|
|
3,246,135 |
|
|
|
(3r |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to common
stockholders |
|
|
(16,561,512 |
) |
|
|
(883,252 |
) |
|
|
(5,083,868 |
) |
|
|
|
|
|
|
(22,528,632 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per common share |
|
|
(0.08 |
) |
|
|
(0.43 |
) |
|
|
|
|
|
|
|
|
|
|
(0.06 |
) |
Basic and diluted weighted average
number of shares |
|
|
207,802,540 |
|
|
|
2,068,990 |
|
|
|
|
|
|
|
(5 |
) |
|
|
358,622,920 |
|
See accompanying notes to the unaudited pro forma consolidated financial statements.
-22-
PSIVIDA LIMITED AND SUBSIDIARIES
Notes to Unaudited Pro Forma Consolidated Financial Statements
(in Australian dollars)
1. |
|
Basis of Presentation |
|
|
|
The unaudited pro forma consolidated financial statements have been prepared in accordance with
US GAAP and are presented in Australian dollars. |
|
2. |
|
Purchase Price Allocation |
|
|
|
The purchase price of US$146,087,658 consists of: |
|
§ |
|
$114,319 cash; |
|
|
§ |
|
150,820,380 ordinary fully paid shares of pSivida (represented by 15,082,038 ADSs),
with an estimated fair value of $133,626,857 ($0.886 per share, represented by
US$6.762 per ADS); |
|
|
§ |
|
9,016,230 nonvested ordinary shares of pSivida (represented by 901,623 nonvested
ADSs), with an estimated fair value of $6,411,358, net of $1,577,021 allocated to
unearned compensation based on the portion of the fair value at the consummation date
related to the future service (vesting) period; |
|
|
§ |
|
1,724,460 share options in pSivida (represented by 172,446 warrants over ADSs),
with an estimated fair value of $685,977; and |
|
|
§ |
|
direct acquisition costs of $5,249,147. |
The purchase price does not include 1,211,180 nonvested ordinary shares (represented by 121,118
nonvested ADSs) issued by pSivida in connection with employee retention agreements for which
employee service subsequent to the consummation date of the acquisition is required in order
for the shares to vest.
A final determination of required purchase accounting adjustments, including the allocation of
the purchase price, has not yet been made. Accordingly, the purchase accounting adjustments
made in connection with these unaudited pro forma consolidated financial statements are
preliminary and have been made solely for the purposes of developing such pro forma
consolidated financial statements.
Following is a preliminary estimate of the allocation of the purchase price as of June 30, 2005:
|
|
|
|
|
|
|
|
|
|
|
Total fair value |
|
|
(in Australian dollars) |
Cash |
|
|
|
|
|
|
4,450,442 |
|
Receivables |
|
|
|
|
|
|
79,413 |
|
Other |
|
|
|
|
|
|
137,450 |
|
Patents |
|
|
|
|
|
|
120,000,000 |
|
In-Process Research and Development |
|
|
|
|
|
|
2,741,706 |
|
Property, Plant and Equipment |
|
|
|
|
|
|
865,412 |
|
Payables |
|
|
|
|
|
|
(2,667,518 |
) |
Deferred Revenue |
|
|
|
|
|
|
(1,864,484 |
) |
Deferred Tax Liability, Net |
|
|
|
|
|
|
(29,100,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
|
94,642,421 |
|
|
Purchase price |
|
|
|
|
|
|
146,087,658 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill |
|
|
|
|
|
|
51,445,237 |
|
|
|
|
|
|
|
|
|
|
- 23 -
PSIVIDA LIMITED AND SUBSIDIARIES
Notes to Unaudited Pro Forma Consolidated Financial Statements
(in Australian dollars)
3. |
|
Pro Forma Adjustments |
|
|
|
Footnotes to the pro forma statements |
|
(a) |
|
Reflects the historical financial position of pSivida as of June 30, 2005 on a US GAAP
basis. Refer to Note 27 of pSividas audited consolidated financial statements which are
incorporated by reference to our Annual Report on Form 20-F for the fiscal year ended June
30, 2005, filed with the SEC on January 18, 2006, for a description of the differences
between A-GAAP and US GAAP as they relate to pSivida and for a reconciliation to US GAAP of
equity for the periods indicated therein. |
|
|
(b) |
|
Reflects the historical financial position of CDS as of June 30, 2005 on a US GAAP
basis. The historical statement of financial position data was translated from US dollars
to Australian dollars using an exchange rate of $0.76 as at June 30, 2005. |
|
|
(c) |
|
Reflects the payment of the $114,319 cash as partial consideration for the acquisition
plus the payment of $5,249,147 for direct acquisition costs. |
|
|
(d) |
|
Reflects the fair value of patents acquired (see Note 2). Such amount will be
amortized over its estimated useful life which has been assumed to be 12 years for purposes
of these pro forma financial statements. |
|
|
(e) |
|
Reflects the residual value of goodwill attributable to the acquisition. Goodwill is
based on a provisional purchase price allocation and is equal to the difference between the
purchase consideration and the estimated fair value of identifiable net assets acquired, as
set forth above in Note 2. Goodwill is not amortized under US GAAP but is assessed for
impairment at least annually. |
|
|
(f) |
|
Reflects the elimination of CDS historical liabilities that pSivida did not assume in
connection with the acquisition. |
|
|
(g) |
|
Reflects a deferred tax liability of $48,000,000 attributable to the difference between
the fair value and tax basis of the acquired patents, offset by a deferred tax asset of
$18,900,000 attributable to the acquired net operating loss carryforwards, using the CDS
combined federal and state statutory tax rate of 40%. No valuation allowance has been
recorded against the deferred tax asset taking into consideration the future reversal of
taxable temporary differences. The actual utilization of the acquired net operating loss
carryforwards may be subject to limitation due to the change of ownership provision of
Section 382 of the Internal Revenue Code. The Company has not yet completed the calculation
of this annual limitation. See Note 2. |
|
|
(h) |
|
Reflects the elimination of CDS Series A redeemable preferred stock. |
|
|
(i) |
|
Reflects the following adjustments (see Note 2): |
|
|
|
|
|
|
|
$ |
|
Fair value of 150,820,380 pSivida ordinary shares issued |
|
|
133,626,857 |
|
Fair value of 9,016,230 pSivida nonvested ordinary shares issued |
|
|
7,988,379 |
|
Unearned compensation attributable to the above |
|
|
(1,577,021 |
) |
Fair value of 1,211,180 pSivida nonvested ordinary shares issued |
|
|
846,326 |
|
Unearned compensation attributable to the above |
|
|
(846,326 |
) |
Fair value of 1,724,460 pSivida share options issued |
|
|
685,977 |
|
Elimination of CDS common stock and APIC |
|
|
(16,362,738 |
) |
|
|
|
|
|
|
|
124,361,454 |
|
|
|
|
|
|
(j) |
|
Reflects the elimination of CDS deferred stock compensation. |
- 24 -
PSIVIDA LIMITED AND SUBSIDIARIES
Notes to Unaudited Pro Forma Consolidated Financial Statements
(in Australian dollars)
|
(k) |
|
Reflects the estimated write-off of in-process research and development related to the
acquisition of CDS (see Note 2). |
|
|
(l) |
|
Reflects the elimination of CDS accumulated deficit. |
|
|
(m) |
|
Reflects the historical results of operations of pSivida for the year ended June 30,
2005 on a US GAAP basis. Refer to Note 27 of pSividas audited consolidated financial
statements which are incorporated by reference to our Annual Report on Form 20-F for the
fiscal year ended June 30, 2005, filed with the SEC on January 18, 2006, for a description
of the differences between A-GAAP and US GAAP as they relate to pSivida and for a
reconciliation to US GAAP of net loss for the periods indicated therein. |
|
|
(n) |
|
Reflects the historical results of operations of CDS on a US GAAP basis for the period
July 1, 2004 to June 30, 2005, which have been derived by combining the US GAAP results of
operations for the 12 months to December 31, 2004 (which are incorporated by reference to
our Supplemental Disclosure submitted on Form 6-K furnished to the SEC on December 22,
2005) minus the US GAAP results of operations for the six months to June 30, 2004 plus the
US GAAP results of operations for the six months to June 30, 2005. The historical
statement of financial performance data was translated from US dollars to Australian
dollars using a weighted average exchange rate of $0.754 for the year ended June 30, 2005. |
|
|
(o) |
|
Reflects the amortization of patents over an estimated useful life of 12 years as
described in adjustment (d) above. |
|
|
(p) |
|
Reflects the amortization of the unearned compensation attributable to the pSivida
nonvested shares, described in adjustment (i) above, over the service (vesting) period. The
individual awards vest over a minimum service period of six months to a maximum service
period of three years from the acquisition date. |
|
|
(q) |
|
Reflects the deferred tax benefit attributable to the reduction of the gross deferred
tax liability described in adjustment (g) above over the 12 year amortization period of
acquired patents, partially offset by deferred tax expense due to a change in the CDS
historical valuation allowance as a result of the acquisition, using the CDS combined
federal and state statutory tax rate of 40%. There is no impact on current income taxes due
to the net operating loss of the combined entity. |
|
|
(r) |
|
Reflects the elimination of accretion of the CDS Series A redeemable preferred stock
due to the elimination of the stock as described in adjustment (h) above. |
4. |
|
In-process research and development |
|
|
|
As indicated in Note 2, pSivida incurred a charge related to this transaction for in-process
research and development of $2,741,706. Such adjustment has been excluded from the pro forma
consolidated statement of operations as the charge is a non-recurring charge directly
attributable to the acquisition. |
- 25 -
PSIVIDA LIMITED AND SUBSIDIARIES
Notes to Unaudited Pro Forma Consolidated Financial Statements
(in Australian dollars)
5. |
|
Loss per share |
|
|
|
Pro forma per share data is based on the number of shares of pSividas ordinary shares that
would have been outstanding had the acquisition of CDS occurred on July 1, 2004. In order to
compute the number of ordinary shares used in the calculation of pro forma basic and diluted
loss per common share, the number of ordinary shares (represented by ADSs) to be issued by
pSivida to former holders of shares in CDS common stock and preferred stock was added to the
weighted average number of pSivida ordinary shares outstanding for the year ended June 30,
2005. Under the terms of the agreements a total of 150,820,380 ordinary shares (represented
by 15,082,038 ADSs) have been issued in exchange for the outstanding CDS common and
preferred shares on the date of the acquisition. A reconciliation of shares used to compute
historical basic and diluted loss per share to shares used to compute pro forma basic and
diluted loss per common share follows: |
|
|
|
|
|
|
|
Year ended |
|
|
|
June 30, 2005 |
|
Ordinary shares used to compute pSivida historical basic and
diluted loss per share |
|
|
207,802,540 |
|
Ordinary shares issued to former holders of shares of vested
CDS common stock |
|
|
74,307,640 |
|
Ordinary shares issued to former holders of shares of CDS
convertible redeemable preferred stock |
|
|
76,512,740 |
|
|
|
|
|
|
Ordinary shares used to compute pro forma basic and diluted
loss per share |
|
|
358,622,920 |
|
|
|
|
|
|
|
|
Securities that could potentially dilute earnings (loss) per share in the future, including
the pSivida nonvested ordinary shares, share options, warrants and the convertible note, are
not included in the computation of pro forma diluted loss per share because the effect would
be antidilutive due to the net loss attributable to common stockholders. |
- 26 -
THE OFFERING
On September 9, 2005, we completed a private placement structured as a private investment in
public equity, commonly known as a PIPE. By means of the PIPE, we sold 665,000 ADSs, representing
6,650,000 ordinary shares, to investors at US$6.50 per ADS together with warrants to acquire up to
66,500 additional ADSs exercisable at US$12.50 per ADS. The warrants expire on the third
anniversary of the September 9, 2005 issue date. The terms of the private placement require us to
register the ordinary shares underlying the ADSs and the warrants within 180 days of the definitive
agreements relating to the PIPE. Warrants to acquire an additional 66,500 ADSs on the same terms
were issued to the entities acting as agents in the placement. However, we have no registration
obligations with respect to the warrants issued to the agents.
This prospectus relates to the offer and sale by certain of the investors in the PIPE during
the period in which the Registration Statement containing this prospectus is effective of up to
5,665,000 ordinary shares represented by 566,500 ADSs consisting of:
|
|
|
up to 515,000 of the 665,000 ADSs issued to investors in the PIPE; and |
|
|
|
|
up to 51,500 of the 66,500 ADSs issuable upon exercise of the warrants issued to
investors in connection with the PIPE. |
The ADSs offered under this prospectus may be sold by the selling shareholders on the NASDAQ
National Market, in negotiated transactions with a broker-dealer or market maker as principal or
agent, or in privately negotiated transactions not involving a broker or dealer. Information
regarding the selling shareholders, the ADSs they are offering to sell under this prospectus and
the times and manner in which they may offer and sell those shares is provided in the sections of
this prospectus captioned Selling Shareholders, Plan of Distribution and Description of
Securities.
The registration of ADSs pursuant to this prospectus does not necessarily mean that any of
those ADSs will ultimately be offered for sale by the selling shareholders.
USE OF PROCEEDS
The proceeds from the sale of ADSs offered pursuant to this prospectus are solely for the
account of the selling shareholders. Accordingly, we will receive no proceeds from the sale of the
ADSs. However, we may receive cash consideration of up to US$1,662,500 in connection with the
exercise of the warrants. The warrants are exercisable at any time before September 9, 2008 at a
price of US$12.50 per ADS. We would use such proceeds for general corporate purposes.
SELLING SHAREHOLDERS
We initially issued the ADSs to the selling shareholders as initial purchasers in a
transaction exempt from the registration requirements of the Securities Act of 1933, as amended. We
have agreed to include in this registration statement the ADSs issued to the selling shareholders
and the ADSs issuable upon the exercise of the warrants.
The selling shareholders, including their transferees, pledges, donees or other successors,
may from time to time offer and sell pursuant to this prospectus any or all of the ADSs covered by
this prospectus. Any selling shareholders may also elect not to sell any of the ADSs covered by
this prospectus held by such shareholders. Only those ADSs listed below or in any prospectus
supplement hereto may be offered for resale by the selling shareholders pursuant to this
prospectus. None of the selling shareholders has, or had, any position, office or other material
relationship with us or any of our affiliates beyond their investment in or receipt of our
securities.
We have agreed with the selling shareholders to use our reasonable efforts to keep the
registration statement of which this prospectus constitutes a part effective until the earlier of
(1) such time as all of the ADSs covered by this prospectus have been disposed of pursuant to and
in accordance with the registration statement, (2) the date on
which the remaining ADSs covered by this prospectus can be sold within a given three-month
period, and (3) August 23, 2007.
- 27 -
The following table is prepared based on information supplied to us by the selling
shareholders. Although we have assumed for purposes of the table below that the selling
shareholders will sell all of the ADSs offered by this prospectus, because the selling shareholders
may offer from time to time all or some of the ADSs covered by this prospectus, or in another
permitted manner, no assurances can be given as to the actual number of ADSs that will be resold by
the selling shareholders or that will be held by the selling shareholders after completion of the
resales. In addition, the selling shareholders may have sold, transferred or otherwise disposed of
the ADSs or the warrants in transactions exempt from the registration requirements of the
Securities Act after providing the information regarding their securities holdings. Information
concerning the selling shareholders may change from time to time and changed information will be
presented in a supplement to this prospectus if and when necessary and required. Except as
described above, we are party to no agreements, arrangements or understandings with respect to the
resale of any of the ADSs covered by this prospectus. Pursuant to the purchase agreements pursuant
to which the ADSs were sold, each of the selling shareholders warranted and covenanted to us that
the selling shareholder was an accredited investor, as that term is defined under the Securities
Act, and experienced in making investments of the kind represented by the ADSs and the warrants and
that the selling shareholders purchased the ADSs in the ordinary course of its business for its own
account for investment only and not with a view towards the public sale or distribution thereof and
not with a view to or for sale in connection with any distribution thereof.
The ADSs offered by this prospectus may be offered from time to time by the persons or
entities named below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ADSs Beneficially Owned |
|
|
|
|
|
ADSs Beneficially Owned |
|
|
Prior to the Offering |
|
|
|
|
|
After the Offering(1) |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
|
|
ADSs |
|
|
|
|
|
Number of |
|
|
|
|
|
ADSs |
|
|
|
|
|
|
|
|
Underlying |
|
|
|
|
|
ADSs |
|
|
|
|
|
Underlying |
|
|
Name of Selling Shareholder |
|
Number |
|
Warrants |
|
Percent |
|
Offered |
|
Number |
|
Warrants |
|
Percent |
Australian IT Investments Limited
c/o Trident Trust Company
11 Bath Street
St. Helier, Jersey
Channel Islands
|
|
|
592,127 |
(2) |
|
|
40,000 |
|
|
|
1.53 |
% |
|
|
400,000 |
|
|
|
192,127 |
|
|
|
0 |
|
|
* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Frank Davis and Lea Bone
2948 Redmond Park Lane
Birmingham, AL 35205
|
|
|
10,000 |
|
|
|
1,000 |
|
|
|
* |
|
|
|
11,000 |
|
|
|
0 |
|
|
|
0 |
|
|
* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lawrence Dickerson and Marcela
Donadio
3704 Farber Street
Houston, TX 77005
|
|
|
10,000 |
|
|
|
1,000 |
|
|
|
* |
|
|
|
11,000 |
|
|
|
0 |
|
|
|
0 |
|
|
* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Jill and Christopher Manning
6147 Orchid Lane
Dallas, TX 75230
|
|
|
10,000 |
|
|
|
1,000 |
|
|
|
* |
|
|
|
11,000 |
|
|
|
0 |
|
|
|
0 |
|
|
* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Kevin McDonough
2726 Woods Lane
Garland, TX 75044
|
|
|
15,000 |
|
|
|
1,500 |
|
|
|
* |
|
|
|
16,500 |
|
|
|
0 |
|
|
|
0 |
|
|
* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gilbert S. Omenn
3340 East Dobson Place
Ann Arbor, MI 48105
|
|
|
10,000 |
|
|
|
1,000 |
|
|
|
* |
|
|
|
11,000 |
|
|
|
0 |
|
|
|
0 |
|
|
* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sheri and Andrew Rosen
200 Crescent Ct., Suite 1600
Dallas, TX 75201
|
|
|
15,000 |
|
|
|
1,500 |
|
|
|
* |
|
|
|
16,500 |
|
|
|
0 |
|
|
|
0 |
|
|
* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sack Family Partners, L.P.
415 LAmbiance Dr.
Longboat Key, FL 34228
|
|
|
15,000 |
|
|
|
1,500 |
|
|
|
* |
|
|
|
16,500 |
|
|
|
0 |
|
|
|
0 |
|
|
* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Marilyn and Daryl Schaller
1709 York Island Dr.
Naples, FL 34112
|
|
|
10,000 |
|
|
|
1,000 |
|
|
|
* |
|
|
|
11,000 |
|
|
|
0 |
|
|
|
0 |
|
|
* |
- 28 -
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ADSs Beneficially Owned |
|
|
|
|
|
ADSs Beneficially Owned |
|
|
Prior to the Offering |
|
|
|
|
|
After the Offering(1) |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
|
|
ADSs |
|
|
|
|
|
Number of |
|
|
|
|
|
ADSs |
|
|
|
|
|
|
|
|
Underlying |
|
|
|
|
|
ADSs |
|
|
|
|
|
Underlying |
|
|
Name of Selling Shareholder |
|
Number |
|
Warrants |
|
Percent |
|
Offered |
|
Number |
|
Warrants |
|
Percent |
Jane and Michael Smith
15903 Roseto Way
Naples, FL 34110
|
|
|
10,000 |
|
|
|
1,000 |
|
|
|
|
* |
|
|
11,000 |
|
|
|
0 |
|
|
|
0 |
|
|
* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Jack Sommer
2820 West Charleston Blvd., #7A
Las Vegas, NV 8910
|
|
|
10,000 |
|
|
|
1,000 |
|
|
|
|
* |
|
|
11,000 |
|
|
|
0 |
|
|
|
0 |
|
|
* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total:
|
|
|
707,127 |
|
|
|
51,500 |
|
|
|
1.96 |
% |
|
|
526,500 |
|
|
|
192,127 |
|
|
|
0 |
|
|
* |
|
|
|
* |
|
Indicates less than 1% |
|
(1) |
|
Assumes all of the ADSs registered are sold. |
|
(2) |
|
Includes 586,000 ordinary shares and 133,527 ADSs held by the shareholder in addition to
400,000 ADSs purchased in the private placement. |
PLAN OF DISTRIBUTION
We are registering the ADSs currently issued to the selling shareholders as well as ADSs
issuable upon exercise of the warrants to permit the resale of these ADSs by the holders of the
ADSs and the warrants from time to time after the date of this prospectus. We will not receive any
of the proceeds from the sale by the selling shareholders of the ADSs. We will bear all fees and
expenses incident to our obligation to register the ADSs.
The selling shareholders may sell all or a portion of the ADSs beneficially owned by them and
offered hereby from time to time directly or through one or more underwriters, broker-dealers or
agents. If the ADSs are sold through underwriters or broker-dealers, the selling shareholders will
be responsible for underwriting discounts or commissions or agents commissions. The ADSs may be
sold in one or more transactions at fixed prices, at prevailing market prices at the time of the
sale, at varying prices determined at the time of sale, or at negotiated prices. These sales may
be effected in transactions, which may involve crosses or block transactions,
|
|
|
on any national securities exchange or quotation service on which the securities may be
listed or quoted at the time of sale; |
|
|
|
|
in the over-the-counter market; |
|
|
|
|
in transactions otherwise than on these exchanges or systems or in the over-the-counter market; |
|
|
|
|
through the writing of options, whether such options are listed on an options exchange or otherwise; |
|
|
|
|
ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
|
|
|
|
block trades in which the broker-dealer will attempt to sell the ADSs as agent but may
position and resell a portion of the block as principal to facilitate the transaction; |
|
|
|
|
purchases by a broker-dealer as principal and resale by the broker-dealer for its account; |
|
|
|
|
an exchange distribution in accordance with the rules of the applicable exchange; |
|
|
|
|
privately negotiated transactions; |
|
|
|
|
short sales; |
|
|
|
|
pursuant to Rule 144 under the Securities Act; |
- 29 -
|
|
|
broker-dealers may agree with one or more selling shareholders to sell a specified
number of such ADSs at a stipulated price per ADS; |
|
|
|
|
a combination of any such methods of sale; and |
|
|
|
|
any other method permitted pursuant to applicable law. |
If the selling shareholders effect such transactions by selling ADSs to or through
underwriters, broker-dealers or agents, such underwriters, broker-dealers or agents may receive
commissions in the form of discounts, concessions or commissions from the selling shareholders or
commissions from purchasers of the ADSs for whom they may act as agent or to whom they may sell as
principal (which discounts, concessions or commissions as to particular underwriters,
broker-dealers or agents may be in excess of those customary in the types of transactions
involved). In connection with sales of the ADSs or otherwise, the selling shareholders may enter
into hedging transactions with broker-dealers, which may in turn engage in short sales of the ADSs
in the course of hedging in positions they assume. The selling shareholders may also sell ADSs
short and deliver ADSs covered by this prospectus to close out short positions. The selling
shareholders may also loan or pledge ADSs to broker-dealers that in turn may sell such ADSs.
The selling shareholders may pledge or grant a security interest in some or all of the notes,
warrants or the ADSs owned by them and, if they default in the performance of their secured
obligations, the pledgees or secured parties may offer and sell the ADSs from time to time pursuant
to this prospectus or any amendment to this prospectus under Rule 424(b)(3) or other applicable
provision of the Securities Act of 1933, as amended, amending, if necessary, the list of selling
shareholders to include the pledgee, transferee or other successors in interest as selling
shareholders under this prospectus. The selling shareholders also may transfer and donate the ADSs
in other circumstances in which case the transferees, donees, pledgees or other successors in
interest will be the selling beneficial owners for purposes of this prospectus.
The selling shareholders and any broker-dealer participating in the distribution of the ADSs
may be deemed to be underwriters within the meaning of the Securities Act, and any commission
paid, or any discounts or concessions allowed to, any such broker-dealer may be deemed to be
underwriting commissions or discounts under the Securities Act. At the time a particular offering
of the ADSs is made, a prospectus supplement, if required, will be distributed which will set forth
the aggregate amount of ADSs being offered and the terms of the offering, including the name or
names of any broker-dealers or agents, any discounts, commissions and other terms constituting
compensation from the selling shareholders and any discounts, commissions or concessions allowed or
reallowed or paid to broker-dealers.
Under the securities laws of some states, the ADSs may be sold in such states only through
registered or licensed brokers or dealers. In addition, in some states the ADSs may not be sold
unless such ADSs have been registered or qualified for sale in such state or an exemption from
registration or qualification is available and is complied with.
There can be no assurance that any selling shareholders will sell any or all of the ADSs
registered pursuant to the shelf registration statement, of which this prospectus forms a part.
The selling shareholders and any other person participating in such distribution will be
subject to applicable provisions of the Securities Exchange Act of 1934, as amended, and the rules
and regulations thereunder, including, without limitation, Regulation M of the Exchange Act, which
may limit the timing of purchases and sales of any of
the ADSs by the selling shareholders and any other participating person. Regulation M may
also restrict the ability of any person engaged in the distribution of the ADSs to engage in
market-making activities with respect to the ADSs. All of the foregoing may affect the
marketability of the ADSs and the ability of any person or entity to engage in market-making
activities with respect to the ADSs.
We will pay all expenses of the registration of the ADSs pursuant to the registration rights
agreement, estimated to be $118,013 in total, including, without limitation, SEC filing fees and
expenses of compliance with state securities or blue sky laws; provided, however, that a selling
shareholders will pay all underwriting discounts and selling commissions, if any. We will
indemnify the selling shareholders against liabilities, including some liabilities under the
Securities Act, in accordance with the registration rights agreements, or the selling shareholders
will be entitled to contribution. We may be indemnified by the selling shareholders against civil
liabilities, including liabilities under the Securities Act, that may arise from any written
information furnished to us by the selling
- 30 -
shareholders specifically for use in this prospectus, in
accordance with the related registration rights agreements, or we may be entitled to contribution.
Once sold under the shelf registration statement, of which this prospectus forms a part, the
ADSs will be freely tradable in the hands of persons other than our affiliates.
DESCRIPTION OF SECURITIES
For a full description of our ADSs and the underlying ordinary shares, please see the
documents identified in the section Incorporation by Reference. As of December 31, 2005,
387,009,956 ordinary shares were issued and outstanding.
PRICE HISTORY OF OUR SECURITIES
Our ordinary shares were listed on the Australian Stock Exchange, referred to as ASX, in
December 2000. The following tables set forth, for the periods indicated, the highest and lowest
market quotations for the ordinary shares reported on the daily official list of the ASX.
Annual High and Low Market Price for the Five Most Recent Fiscal Years on the ASX
|
|
|
|
|
|
|
|
|
Fiscal Year Ended |
|
High |
|
|
Low |
|
June 30, 2005 |
|
A$ |
1.43 |
|
|
A$ |
0.535 |
|
June 30, 2004 |
|
A$ |
1.44 |
|
|
A$ |
0.23 |
|
June 30, 2003 |
|
A$ |
0.275 |
|
|
A$ |
0.10 |
|
June 30, 2002 |
|
A$ |
0.34 |
|
|
A$ |
0.09 |
|
June 30, 2001 |
|
A$ |
0.40 |
|
|
A$ |
0.21 |
|
Quarterly High and Low Market Price for the Two Most Recent Fiscal Years and Any Subsequent Period
on the ASX
|
|
|
|
|
|
|
|
|
Quarter Ended |
|
High |
|
|
Low |
|
December 31, 2005 |
|
A$ |
0.94 |
|
|
A$ |
0.55 |
|
September 30, 2005 |
|
A$ |
0.945 |
|
|
A$ |
0.75 |
|
June 30, 2005 |
|
A$ |
0.935 |
|
|
A$ |
0.535 |
|
March 31, 2005 |
|
A$ |
1.25 |
|
|
A$ |
0.85 |
|
December 31, 2004 |
|
A$ |
1.43 |
|
|
A$ |
1.02 |
|
September 30, 2004 |
|
A$ |
1.16 |
|
|
A$ |
0.90 |
|
June 30, 2004 |
|
A$ |
1.34 |
|
|
A$ |
1.03 |
|
March 31, 2004 |
|
A$ |
1.44 |
|
|
A$ |
0.52 |
|
December 31, 2003 |
|
A$ |
0.70 |
|
|
A$ |
0.51 |
|
September 30, 2003 |
|
A$ |
0.69 |
|
|
A$ |
0.23 |
|
- 31 -
Monthly High and Low Market Price for the Most Recent Six Months on the ASX
|
|
|
|
|
|
|
|
|
Month Ended |
|
High |
|
|
Low |
|
February 28, 2006 |
|
A$ |
0.71 |
|
|
A$ |
0.57 |
|
January 31, 2006 |
|
A$ |
0.73 |
|
|
A$ |
0.60 |
|
December 31, 2005 |
|
A$ |
0.75 |
|
|
A$ |
0.58 |
|
November 30, 2005 |
|
A$ |
0.79 |
|
|
A$ |
0.55 |
|
October 31, 2005 |
|
A$ |
0.94 |
|
|
A$ |
0.72 |
|
September 30, 2005 |
|
A$ |
0.90 |
|
|
A$ |
0.80 |
|
Our ADSs were listed on the NASDAQ National Market in January 2005. The following tables set
forth, for the periods indicated, the highest and lowest market quotations for the ADSs reported on
the daily official list of the NASDAQ National Market.
Quarterly High and Low Market Price for the Most Recent Fiscal Year and Any Subsequent Period on
the NASDAQ National Market
|
|
|
|
|
|
|
|
|
Quarter Ended |
|
High |
|
|
Low |
|
December 31, 2005 |
|
US$ |
7.00 |
|
|
US$ |
4.21 |
|
September 30, 2005 |
|
US$ |
8.75 |
|
|
US$ |
5.60 |
|
June 30, 2005 |
|
US$ |
8.00 |
|
|
US$ |
4.15 |
|
March 31, 2005 |
|
US$ |
12.14 |
|
|
US$ |
6.30 |
|
Monthly High and Low Market Price for the Most Recent Six Months on the NASDAQ National Market
|
|
|
|
|
|
|
|
|
Month Ended |
|
High |
|
|
Low |
|
February 28, 2006 |
|
US$ |
5.46 |
|
|
US$ |
4.40 |
|
January 31, 2006 |
|
US$ |
5.70 |
|
|
US$ |
4.68 |
|
December 31, 2005 |
|
US$ |
5.697 |
|
|
US$ |
4.21 |
|
November 30, 2005 |
|
US$ |
6.00 |
|
|
US$ |
4.21 |
|
October 31, 2005 |
|
US$ |
7.00 |
|
|
US$ |
5.20 |
|
September 30, 2005 |
|
US$ |
6.80 |
|
|
US$ |
6.02 |
|
LEGAL MATTERS
The validity of the ordinary shares will be passed upon by Blake Dawson Waldron, Level 32,
Exchange Plaza, 2 The Esplanade, Perth, WA 6000, Australia, our Australian counsel.
EXPERTS
The consolidated financial statements incorporated in this prospectus by reference from our
Annual Report on Form 20-F for the year ended June 30, 2005 have been audited by Deloitte Touche
Tohmatsu, an independent registered public accounting firm, as stated in their report, which is
incorporated herein by reference, and have been so incorporated in reliance upon the report of such
firm given upon their authority as experts in accounting and auditing.
The financial statements of CDS for the year ending December 31, 2004, incorporated in this
prospectus by reference from our report on Form 6-K furnished to the SEC on December 22, 2005 have
been audited by PricewaterhouseCoopers LLP, an independent registered accounting firm, as stated in
their report appearing therein, which is incorporated herein by reference, and have been so
incorporated in reliance upon said report given upon their authority as experts in accounting and
auditing.
- 32 -
ENFORCEABILITY OF CIVIL LIABILITIES
We are a public company limited by shares incorporated under the laws of Western Australia.
Most of our directors and executive officers and current employees named in this Registration
Statement reside outside the United States, and the assets of those non-resident directors and most
of our assets are located outside the United States. It may be difficult for investors to effect
service of process upon these directors and executive officers. In addition, there may be
difficulties in certain circumstances in using the courts of Australia to enforce judgments
obtained in United States courts in actions against pSivida or its directors, including judgments
based on the civil liability provisions of the federal securities laws of the United States.
EXPENSES
We will pay all expenses in connection with the registration and sale of the ADSs by the
selling shareholders. The estimated expenses of issuance and distribution are set forth below.
|
|
|
|
|
SEC Registration Fees |
|
$ |
353 |
|
Transfer Agent Fees |
|
$ |
22,660 |
|
Legal Fees and Expenses |
|
$ |
75,000 |
|
Accounting Fees |
|
$ |
15,000 |
|
Miscellaneous (including EDGAR filing costs) |
|
$ |
5,000 |
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
118,013 |
|
|
|
|
|
WHERE YOU CAN FIND ADDITIONAL INFORMATION
As required by the Securities Act, we have filed with the SEC a registration statement on Form
F-3, of which this prospectus is a part, with respect to the ADSs offered hereby. This prospectus
does not contain all of the information included in the registration statement. Statements in this
prospectus concerning the provisions of any document are not necessarily complete. You should refer
to the copies of the documents filed as exhibits to the registration statement or otherwise filed
by us with the SEC for a more complete understanding of the matter involved. Each statement
concerning these documents is qualified in its entirety by such reference.
We are subject to the information reporting requirements of the Securities and Exchange Act of
1934, as amended, applicable to foreign private issuers and we comply with those requirements by
submitting reports to the SEC. Those reports or other information may be inspected without charge
at the SECs Public Reference Room at 100 F Street, N.E., Washington, D.C. 20549. Information on
the operation of the Public Reference Room can be obtained by calling the SEC at 1-800-SEC-0330.
Our SEC filings and submissions also are available to the public on the SECs website at
www.sec.gov. As a foreign private issuer, we are exempt from the rules under the Exchange
Act related to the furnishing and content of proxy statements, and our officers, directors and
principal shareholders are exempt from the reporting and short-swing profit recovery provisions
contained in Section 16 of the Exchange Act. In addition, we are not required under the Exchange
Act to file quarterly and current reports with the SEC, unlike United States companies whose
securities are registered under the Exchange Act. However, we are required to file with the SEC,
within 180 days after the end of each fiscal year, an annual report on Form 20-F containing
financial statements audited by an independent registered public accounting firm.
INCORPORATION BY REFERENCE
The SEC allows us to incorporate by reference in this prospectus the information that we
file with them. This means that we can disclose important information to you in this document by
referring you to other filings we have made with the SEC. The information incorporated by reference
is considered to be part of this prospectus, and later information we file with the SEC will update
and supersede this information. We incorporate by reference the documents listed below:
|
|
|
Our Annual Report on Form 20-F for the fiscal year ended June 30, 2005, filed with
the SEC on January 18, 2006; |
|
|
|
|
Our report on Form 6-K furnished to the SEC on December 22, 2005; |
33
|
|
|
Our report on Form 6-K furnished to the SEC on January 31, 2006; |
|
|
|
|
Our report on Form 6-K furnished to the SEC on February 22, 2006; |
|
|
|
|
Our two reports on Form 6-K furnished to the SEC on February 23, 2006; |
|
|
|
|
Our report on Form 6-K furnished to the SEC on March 2, 2006; |
|
|
|
|
Our report on Form 6-K furnished to the SEC on March 17, 2006; and |
|
|
|
|
The description of our securities contained in our Registration Statement on Form
20-F, filed with the SEC on January 20, 2005 and any amendment or report filed for the
purpose of updating that description. |
In addition, all subsequent annual reports filed on Form 20-F prior to the termination of this
offering are incorporated by reference into this prospectus. Also, we may incorporate by reference
our future reports on Form 6-K by stating in those Forms that they are being incorporated by
reference into this prospectus.
This prospectus may contain information that updates, modifies or is contrary to information
in one or more of the documents incorporated by reference in this prospectus. Reports we file with
the SEC after the date of this prospectus may also contain information that updates, modifies or is
contrary to information in this prospectus or in documents incorporated by reference in this
prospectus. Investors should review these reports as they may disclose a change in our business,
prospects, financial condition or other affairs after the date of this prospectus.
Upon your written or oral request, we will provide at no cost to you a copy of any and all of
the information that is incorporated by reference in this prospectus.
Requests for such documents should be directed to:
Lori Freedman, Esq.
Vice President for Corporate Affairs, General Counsel and Secretary
pSivida Inc.
400 Pleasant Street
Watertown, MA 02472
Telephone: (617) 926-5000
You may also access the documents incorporated by reference in this prospectus through our website
www.psivida.com. Except for the specific incorporated documents listed above, no information
available on or through our website shall be deemed to be incorporated in this prospectus or the
registration statement of which it forms a part.
34
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 8. Indemnification of Directors and Officers
Constitution
Our constitution states that we must, to the extent the person is not otherwise indemnified,
indemnify every officer of pSivida or its wholly-owned subsidiaries and may indemnify our auditors
against any liabilities to third parties arising from service to pSivida, except for any
liabilities arising out of conduct involving a lack of good faith.
In addition, we may advance funds to cover legal costs incurred by any officer or auditor in
defending against liabilities arising from service to pSivida.
The Australian Corporations Act 2001 permits a company to purchase and maintain insurance on
behalf of directors, other officers or auditors of pSivida against any liability (other than legal
costs) except liability arising out of conduct involving a willful breach of duty, the improper use
of information acquired by virtue of his or her position, or the improper use of his or her
position to gain an advantage for himself or herself or any other person, or to cause detriment to
pSivida. Our constitution authorizes us to purchase and maintain liability insurance, subject to
Australian law.
The indemnity in favor of officers is a continuing indemnity which applies in respect of all
acts done by a person while an officer of pSivida or one of its wholly owned subsidiaries even
though the person is not an officer at the time the claim is made.
Subject to Australian law, we may enter into an indemnification agreement with a person who is
or has been an officer of pSivida or any of its subsidiaries, to give effect to the indemnification
rights provided for in the Constitution.
Australian Law
Section 199A(1) of the Corporations Act 2001 (Commonwealth) provides that a company or a
related body corporate must not exempt a person from a liability to the company incurred as an
officer of the company. Section 199A(2) of the Corporations Act provides that a company or a
related body corporate must not indemnify a person against any of the following liabilities
incurred as an officer of the company:
a liability owed to the company or a related body corporate;
a liability for a pecuniary penalty order or compensation order under specified provisions
of the Corporations Act; or
a liability that is owed to someone other than the company or a related body corporate that
did not arise out of conduct in good faith.
Section 199A(2) does not apply to a liability for legal costs.
Section 199A(3) provides that a company or a related body corporate must not indemnify a
person against legal costs incurred in defending an action for a liability incurred as an officer
of the company if the costs are incurred:
in defending or resisting proceedings in which the person is found to have a liability for
which they could not be indemnified under Section 199A(2); or
in defending or resisting criminal proceedings in which the person is found guilty; or
in defending or resisting proceedings brought by the Australian Securities and Investments
Commission (ASIC) or a liquidator for a court order if the grounds for making the order are found
by the court to have been
II-1
established (this does not apply to costs incurred in responding to actions taken by ASIC or a
liquidator as part of an investigation before commencing proceedings for the court order); or
in connection with proceedings for relief to the person under the Corporations Act in which
the court denies the relief.
Section 199B of the Corporations Act provides that a company or a related body corporate must
not pay, or agree to pay, a premium for a contract insuring a person who is or has been an officer
of the company against a liability (other than one for legal costs) arising out of:
conduct involving a willful breach of any duty in relation to the company; or
a contravention of the officers duties under the Corporations Act not to improperly use
their position or make improper use of information obtained as an officer.
For the purpose of Sections 199A and 199B, an officer of a company includes:
a director or secretary;
a person who makes, or participates in making, decisions that affect the whole, or a
substantial part, of the business of the company;
a person who has the capacity to significantly affect the companys financial standing; and
a person in accordance with whose instructions or wishes the directors of the company are
accustomed to act.
Item 9. Exhibits
|
|
|
Exhibit No. |
|
Exhibit Title |
2.1
|
|
Merger Agreement, dated October 3, 2005, among pSivida Limited, pSivida Inc.,
and Control Delivery Systems Inc. (c) |
|
|
|
4.1
|
|
Deposit Agreement, by and among pSivida Limited, Citibank, N.A. and the Holders
and Beneficial Owners of American Depositary Shares Evidenced by American
Depositary Receipts Issued Thereunder (b) |
|
|
|
4.2
|
|
Form of Securities Purchase Agreement, dated August 23, 2005, between pSivida
Limited and the purchasers of its ADSs in the PIPE transaction (a) (d) |
|
|
|
4.3
|
|
Form of Warrant issued by pSivida Limited to the purchasers of its ADSs in the
PIPE transaction on
September 9, 2005 (a) (d) |
|
|
|
5.1
|
|
Legal Opinion of Blake Dawson Waldron LLP* |
|
|
|
23.1
|
|
Consent of PricewaterhouseCoopers LLP, dated March 24, 2006 (a) |
|
|
|
23.2
|
|
Consent of Deloitte Touche Tohmatsu
dated March 28, 2006 (a) |
|
|
|
23.3
|
|
Consent of Blake Dawson Waldron LLP (to be contained in the opinion filed as
Exhibit 5.1 to this Registration Statement)* |
|
|
|
24.1
|
|
Power of Attorney (included on the signature page of this Registration Statement) |
|
|
|
* |
|
To be filed by amendment. |
|
(a) |
|
Filed herewith. |
|
(b) |
|
Incorporated by reference to the registrants filing on Form F-6 (Commission file number
333-122158) filed on January 19, 2005. |
|
(c) |
|
Incorporated by reference to the registrants later filing on Form 6 K (Commission file number
000-51122) filed on October 4, 2005. The agreement filed omitted certain schedules containing
immaterial information; the registrant agrees to furnish supplemental copies of any omitted
schedules to the Commission upon request. |
|
(d) |
|
The final versions of documents denoted as Form of have been omitted pursuant to Rule 12b-31.
pSivida Limited has entered into such agreements with each of the participants in the PIPE
transaction. Such final versions are substantially identical in all respects except for the
inclusion of the identity of the purchaser, the number of ADSs subject to such agreement and the
investors and/or pSividas signature in the final versions. |
II-2
Item 10. Undertakings
The undersigned registrant hereby undertakes:
|
(1) |
|
To file, during any period in which offers or sales are being made, a post-effective
amendment to this registration statement: |
|
(i) |
|
To include any prospectus required in Section 10(a)(3) of the Securities Act of
1933; |
|
|
(ii) |
|
To reflect in the prospectus any facts or events arising after the effective
date of the registration statement (or the most recent post-effective amendment
thereof) which, individually or in the aggregate, represent a fundamental change in the
information set forth in the registration statement. Notwithstanding the foregoing, any
increase or decrease in volume of securities offered (if the total dollar value of
securities offered would not exceed that which was registered) and any deviation from
the low or high end of the estimated maximum offering range may be reflected in the
form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the
aggregate, the changes in volume and price represent no more than 20% change in the
maximum aggregate offering price set forth in the Calculation of Registration Fee
table in the effective registration statement; and |
|
|
(iii) |
|
To include any material information with respect to the Plan of Distribution
not previously disclosed in the registration statement or any material change to such
information in the registration statement; |
Provided, however, that:
|
(A) |
|
Paragraphs (1)(i) and (1)(ii) of this section do not apply if the
registration statement is on Form S-8, and the information required to be included
in a post- effective amendment by those paragraphs is contained in reports filed
with or furnished to the Commission by the registrant pursuant to section 13 or
section 15(d) of the Securities Exchange Act of 1934 that are incorporated by
reference in the registration statement; and |
|
|
(B) |
|
Paragraphs (1)(i), (1)(ii) and (1)(iii) of this section do not apply if
the registration statement is on Form S-3 or Form F-3 and the information required
to be included in a post-effective amendment by those paragraphs is contained in
reports filed with or furnished to the Commission by the registrant pursuant to
section 13 or section 15(d) of the Securities Exchange Act of 1934 that are
incorporated by reference in the registration statement, or is contained in a form
of prospectus filed pursuant to Rule 424 (b) that is part of the registration
statement. |
|
|
(C) |
|
Provided further, however, that paragraphs (1)(i) and (1)(ii) do not
apply if the registration statement is for an offering of asset-backed securities
on Form S-1 or Form S-3, and the information required to be included in a
post-effective amendment is provided pursuant to Item 1100(c) of Regulation AB. |
|
(2) |
|
That, for the purpose of determining any liability under the Securities Act of 1933,
each such post-effective amendment shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of such securities at that
time shall be deemed to be the initial bona fide offering thereof; |
|
|
(3) |
|
To remove from registration by means of a post-effective amendment any of the
securities being registered which remain unsold at the termination of the offering; |
|
|
(4) |
|
To file a post-effective amendment to the registration statement to include any
financial statements required by Item 8.A of Form 20-F at the start of any delayed offering
or throughout a continuous offering. Financial statements and information otherwise
required by Section 10(a)(3) of the Securities Act of 1933 need not be furnished, provided,
that the registrant includes in the prospectus, by means of a post-effective amendment,
financial statements required pursuant to this paragraph (4) and other information
necessary to ensure that all other information in the prospectus is at lest as current as
the date of those financial statements. Notwithstanding the foregoing, with respect to
registration statements on Form F-3, a post-effective amendment need not be filed to
include financial statements and information required by Section 10(a)(3) of the Securities
Act or Rule 3-19 if such financial statements and information are contained in |
II-3
|
|
|
periodic reports filed with or furnished to the Commission by the registrant pursuant to
Section 13 or Section 15(d) of the Securities Exchange Act of 1934 that are incorporated by
reference in Form F-3; |
|
|
(5) |
|
That, for the purpose of determining liability under the Securities Act of 1933 to any
purchaser: |
|
(i) |
|
If the registrant is relying on Rule 430B: |
|
(A) |
|
Each prospectus filed by the registrant pursuant to Rule 424(b)(3)
shall be deemed to be part of the registration statement as of the date the filed
prospectus was deemed part of and included in the registration statement; and |
|
|
(B) |
|
Each prospectus required to be filed pursuant to Rule 424(b)(2),
(b)(5), or (b)(7) as part of a registration statement in reliance on Rule 430B
relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the
purpose of providing the information required by section 10(a) of the Securities
Act of 1933 shall be deemed to be part of and included in the registration
statement as of the earlier of the date such form of prospectus is first used after
effectiveness or the date of the first contract of sale of securities in the
offering described in the prospectus. As provided in Rule 430B, for liability
purposes of the issuer and any person that is at that date an underwriter, such
date shall be deemed to be a new effective date of the registration statement
relating to the securities in the registration statement to which that prospectus
relates, and the offering of such securities at that time shall be deemed to be the
initial bona fide offering thereof. Provided, however, that no statement made in a
registration statement or prospectus that is part of the registration statement or
made in a document incorporated or deemed incorporated by reference into the
registration statement or prospectus that is part of the registration statement
will, as to a purchaser with a time of contract of sale prior to such effective
date, supersede or modify any statement that was made in the registration statement
or prospectus that was part of the registration statement or made in any such
document immediately prior to such effective date; or |
|
(ii) |
|
If the registrant is subject to Rule 430C, each prospectus filed pursuant to
Rule 424(b) as part of a registration statement relating to an offering, other than
registration statements relying on Rule 430B or other than prospectuses filed in
reliance on Rule 430A, shall be deemed to be part of and included in the registration
statement as of the date it is first used after effectiveness. Provided, however, that
no statement made in a registration statement or prospectus that is part of the
registration statement or made in a document incorporated or deemed incorporated by
reference into the registration statement or prospectus that is part of the
registration statement will, as to a purchaser with a time of contract of sale prior to
such first use, supersede or modify any statement that was made in the registration
statement or prospectus that was part of the registration statement or made in any such
document immediately prior to such date of first use. |
|
(6) |
|
That, for purposes of determining any liability under the Securities Act of 1933, each
filing of the registrants annual report pursuant to Section 13(a) or Section 15(d) of the
Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit
plans annual report pursuant to Section 15(d) of the Securities Exchange Act of 1934) that
is incorporated by reference in the registration statement shall be deemed to be a new
registration statement relating to the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering thereof. |
Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be
permitted to directors, officers and controlling persons of the registrant pursuant to the
provisions described under Item 8 above, or otherwise, the registrant has been advised that in the
opinion of the SEC such indemnification is against public policy as expressed in the Securities Act
and is, therefore, unenforceable. In the event that a claim for indemnification against such
liabilities (other than the payment by the registrant of expenses incurred or paid by a director,
officer or controlling person of the registrant in the successful defense of any action, suit or
proceeding) is asserted by such director, officer or controlling person in connection with the
securities being registered, the registrant will, unless in the opinion of its counsel the matter
has been settled by controlling precedent, submit to a court of appropriate jurisdiction the
question whether such indemnification by it is against public policy as expressed in the Securities
Act and will be governed by the final adjudication of such issue.
II-4
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the registrant certifies that it
has reasonable grounds to believe that it meets all of the requirements for filing on Form F-3 and
has duly caused this registration statement to be signed on its behalf by the undersigned,
thereunto duly authorized, in the City of Perth, Western Australia on
March 17, 2006.
|
|
|
|
|
|
PSIVIDA LIMITED
|
|
|
By: |
/s/ Gavin Rezos
|
|
|
|
Name: |
Gavin Rezos |
|
|
|
Title: |
Chief Executive Officer and Managing Director |
|
|
|
|
|
|
|
|
|
|
|
By: |
/s/Aaron Finlay
|
|
|
|
Name: |
Aaron Finlay |
|
|
|
Title: |
Chief Financial Officer and Company Secretary |
|
|
Each of the undersigned hereby constitutes and appoints Gavin Rezos and Aaron Finlay, in each
case acting individually, his true and lawful attorney-in-fact, with power of substitution and
resubstitution, in his name, place and stead, in any and all capacities, to sign any or all
amendments, including post-effective amendments, and supplements to this Registration Statement or
any related registration statement that is to be effective upon filing pursuant to Rule 462(b)
under the Securities Act of 1933, as amended, and to file the same, with all exhibits thereto and
other documents in connection therewith, with the Securities and Exchange Commission, granting unto
said attorneys-in-fact and agents, and each of them, full power and authority to do and perform
each and every act and thing requisite and necessary to be done in connection therewith, as fully
to all intents and purposes as he or she might or could do in person, hereby ratifying and
confirming all that each said attorney-in-fact, or his substitute or substitutes, may lawfully do
or cause to be done by virtue hereof.
Pursuant to the requirements of the U.S. Securities Act of 1933, as amended, this Registration
Statement has been signed by or on behalf of the following persons in the capacities indicated as
of March 17, 2006.
|
|
|
Name |
|
Title |
|
|
|
/s/ Roger Brimblecombe
Name: Roger Brimblecombe
|
|
Chairman of the Board of Directors, Non-Executive
Director |
|
|
|
/s/ Gavin Rezos
Name: Gavin Rezos
|
|
Chief Executive Officer and Managing Director
(principal executive officer) |
|
|
|
/s/ David Mazzo
Name: David Mazzo
|
|
Director |
|
|
|
/s/ Aaron Finlay
Name: Aaron Finlay
|
|
Chief Financial Officer and Company Secretary
(principal accounting officer) |
|
|
|
/s/Paul Ashton
Name: Paul Ashton
|
|
Director; Authorized Representative in the United States |
|
|
|
/s/ Stephen Lake
Name: Stephen Lake
|
|
Director |
|
|
|
/s/ Michael W. Rogers
Name: Michael W. Rogers
|
|
Director |
|
|
|
/s/ Heather Zampatti
Name: Heather Zampatti
|
|
Director |
II-5
Exhibit 4.2
FORM OF SECURITIES PURCHASE AGREEMENT
This Securities Purchase Agreement, dated as of the date of acceptance set
forth below, is between PSIVIDA LIMITED, an Australian company (the "Company"),
and the undersigned (the "Buyer").
The Company and the Buyer are executing and delivering this Agreement in
accordance with and in reliance upon the exemption from securities registration
afforded, inter alia, by Rule 506 under Regulation D ("Regulation D") as
promulgated by the United States Securities and Exchange Commission (the "SEC")
under the Securities Act of 1933, as amended (the "1933 Act"), and/or Section
4(2) of the 1933 Act.
The Buyer wishes to purchase, upon the terms and subject to the conditions
of this Agreement, (i) such number of American Depositary Shares of the Company,
each representing ten (10) ordinary shares of the Company, as is stated on the
signature page of this Agreement (those American Depositary Shares, the
"Shares"), and (ii) a warrant in the form set forth in Exhibit A hereto (the
"Warrant") to purchase such number of American Depositary Shares of the Company
as is stated on the signature page of this Agreement (American Depositary Shares
issuable in connection with the exercise of the Warrant, the "Warrant Shares"),
subject to acceptance of this Agreement by the Company.
The parties therefore agree as follows:
1. Agreement to Purchase; Purchase Price. The undersigned hereby purchases
from the Company the Shares and the Warrant for the purchase price stated on the
signature page of this Agreement. The Buyer shall pay the purchase price for the
Shares and the Warrant by delivering to the Company on the date of this
Agreement immediately available funds in United States Dollars. Upon acceptance
of this Agreement by the Company and receipt of the purchase price, the Company
shall promptly deliver a binding and irrevocable instruction letter to the
Company's Depositary instructing the Depositary to issue an American Depositary
Receipt to the Buyer representing the Shares and shall deliver to the Buyer the
Warrant.
2. Buyer Representations; Access to Information; Independent Investigation.
The Buyer represents to, and agrees with, the Company as follows:
(a) Without limiting the Buyer's right to sell the Shares under a
Registration Statement (as defined below) or the Warrant Shares pursuant to the
terms set forth herein and in the Warrant, the Buyer is purchasing the Shares
and the Warrant in the ordinary course of its business for its own account for
investment only and not with a view towards the public sale or distribution
thereof and not with a view to or for sale in connection with any distribution
thereof.
(b) The Buyer is (1) an "accredited investor" as that term is defined
in Rule 501 of the General Rules and Regulations under the 1933 Act by reason of
Rule 501(a)(3), (2) experienced in making investments of the kind represented by
the Shares and the Warrant, (3) able, by reason of the business and financial
experience of its officers (if an entity) and professional advisors (who are not
affiliated with or compensated in any way by the Company or
any of its affiliates or selling agents), to protect its own interests in
connection with the transactions described in this Agreement, and (4) able to
afford the entire loss of its investment in the Shares and the Warrant.
(c) All subsequent offers and sales of the Shares, the Warrant or the
Warrant Shares by the Buyer shall be made (i) pursuant to registration of the
Shares or Warrant Shares under the 1933 Act or pursuant to an exemption from
registration and (ii) in compliance with applicable blue sky laws and
regulations.
(d) The Buyer understands that the Shares and the Warrant are being
offered and sold to the Buyer in reliance on specific exemptions from the
registration requirements of United States federal and state securities laws and
that the Company is relying upon the truth and accuracy of, and the Buyer's
compliance with, the representations, agreements, acknowledgements and
understandings of the Buyer set forth herein in order to determine the
availability of those exemptions and the eligibility of the Buyer to acquire the
Shares and the Warrant.
(e) The Buyer and the Buyer's advisors, if any, have been furnished
with all materials relating to the business, finances and operations of the
Company and materials relating to the offer and sale of the Shares and the
Warrant that the Buyer has requested. The Buyer and its advisors, if any, have
been afforded the opportunity to ask questions of the Company and have received
complete and satisfactory answers to any such inquiries. Without limiting the
generality of the foregoing, the Buyer has also had the opportunity to obtain
and to review the Company's SEC Documents (as defined below).
(f) The Buyer understands that its investment in the Shares and the
Warrant involves a high degree of risk.
(g) The Buyer understands that no United States federal or state
agency or any other government or governmental agency has passed on or made any
recommendation or endorsement of the Shares or the Warrant.
(h) This Agreement has been duly and validly authorized, executed and
delivered on behalf of the Buyer and is a valid and binding agreement of the
Buyer enforceable in accordance with its terms, subject as to enforceability to
general principles of equity and to bankruptcy, insolvency, moratorium and other
similar laws affecting the enforcement of creditors' rights generally.
(i) The Buyer has, in connection with its decision to purchase the
Shares and the Warrant, relied with respect to the Company and its affairs
solely upon the Company's SEC Documents, the representations and warranties of
the Company herein, and other information provided to the Purchaser and oral
statements of the Company's management made at meetings with the Purchaser.
(j) The Buyer has not engaged and will not engage in any short sales
of the Company's ordinary shares or American Depositary Shares prior to the
effectiveness of the Initial
2
Registration Statement, except to the extent that any such short sale is fully
covered by shares of the Company's stock other than the Shares and Warrant
Shares.
(k) The Buyer understands that nothing in this Agreement or any other
materials presented to the Buyer in connection with the purchase and sale of the
Shares and the Warrant constitutes legal, tax or investment advice and that no
independent legal counsel has reviewed these documents and materials on the
Buyer's behalf. The Buyer has consulted such legal, tax and investment advisors
as it, in its sole discretion, has deemed necessary or appropriate in connection
with its purchase of the Shares and the Warrant.
(l) Notwithstanding any other provision of this Agreement, the Buyer
agrees and undertakes to the Company that the Buyer will not offer to transfer
or otherwise dispose of, or agree to the transfer or disposal of, the Shares,
the Warrant, or the Warrant Shares (or the fully paid ordinary shares underlying
either of them) in Australia (including through trading on the Australian Stock
Exchange) at any time prior to:
(1) the Company's subsequent lodgment with the Australian
Securities and Investments Commission of a prospectus under the
Corporations Act 2001 (Cth) for fully paid ordinary shares of the
Company (such prospectus incorporating the Initial Registration
Statement or the Demand Registration Statement (as defined in
Section 5 below) or extracts of the Initial Registration
Statement or the Demand Registration Statement as deemed
appropriate by the Company); or
(2) the date which is 12 months after the date of issue of the
Shares and the Warrant,
(whichever occurs first).
(m) The Buyer acknowledges that the Company may take any measures the
Company considers necessary or appropriate (in its sole discretion) in relation
to Section 2(l) above, and in particular that the ordinary shares underlying the
Shares and Warrant Shares will be subject to a holding lock on the Company's
Australian register, and entered into a restricted securities sub-register where
transfers of the shares cannot occur without the Company's prior consent.
3. Company Representations. The Company represents to the Buyer as follows:
(a) The Company is a company duly organized and in good standing under
the laws of Australia, and has the requisite corporate power to own its
properties and to carry on its business as now being conducted. The Company is
duly qualified as a foreign corporation to do business and is in good standing
in each jurisdiction where the nature of the business conducted or property
owned by it makes such qualification necessary, other than those jurisdictions
in which the failure to so qualify would not have a material adverse effect on
the business, operations, properties or condition (financial or otherwise) of
the Company and its subsidiaries taken as a whole (an "MAE").
3
(b) The Shares have been duly authorized and, when issued to Buyer,
will be duly and validly issued, fully paid and non-assessable and will not
subject the holder thereof to personal liability by reason of being such a
holder.
(c) This Agreement and the transaction contemplated hereby have been
duly and validly authorized by the Company, this Agreement has been duly
executed and delivered by the Company, and this Agreement, when executed and
delivered by the Company, will be a valid and binding agreement of the Company
enforceable in accordance with its terms, subject as to enforceability to
general principles of equity and to bankruptcy, insolvency, moratorium, and
other similar laws affecting the enforcement of creditors' rights generally.
(d) The execution and delivery of this Agreement by the Company, the
issuance of the Shares and the Warrant, and the consummation by the Company of
the other transactions contemplated by this Agreement do not and will not
conflict with or result in a breach by the Company of any of the terms or
provisions of, or constitute a default under (1) the organizational documents of
the Company, (2) any indenture, mortgage, deed of trust, or other material
agreement or instrument to which the Company is a party or by which it or any of
its properties or assets are bound, (3) to its knowledge, any existing
applicable law, rule, or regulation or any applicable decree, judgment, or (4)
to its knowledge, order of any court, administrative agency, or other
governmental body having jurisdiction over the Company or any of its properties
or assets, except such conflict, breach or default that would not have a
material adverse effect on the transaction contemplated herein. The Company is
not in violation of any laws, governmental orders, rules, regulations or
ordinances to which its property, real, personal, mixed, tangible or intangible,
or its businesses related to such properties, are subject except any such
violation that would not have an MAE.
(e) No authorization, approval or consent of any court, governmental
body, regulatory agency, self-regulatory organization, or stock exchange or
market is required to be obtained by the Company for the issuance and sale of
the Shares and the Warrant to the Buyer as contemplated by this Agreement,
except such authorizations, approvals and consents that have been obtained and
that no representation is made with respect to filings under states securities
or blue sky laws.
(f) The American Depositary Shares of the Company are listed on the
Nasdaq National Market. The Company is in material compliance with the listing
and maintenance requirements for continued listing of the American Depositary
Shares of the Company on the Nasdaq National Market. The Company has filed on a
timely basis all reports, schedules, forms, statements and other documents
required to be filed by it in 2005 with the SEC (the "Company's SEC Documents").
The Company has disclosed publicly all information which, according to
applicable law, rule or regulation, should have been disclosed publicly by the
Company, other than with respect to the transaction contemplated by this
Agreement.
(g) As of their respective dates, the Company's SEC Documents complied
in all material respects with the requirements of the 1933 Act or the Securities
Exchange Act of 1934, as amended, as the case may be and the rules and
regulations of the SEC promulgated thereunder and other federal, state and local
laws, rules and regulations applicable to the
4
Company's SEC Documents, and none of the Company's SEC Documents contained any
untrue statement of a material fact or omitted to state a material fact required
to be stated therein or necessary in order to make the statements therein, in
light of the circumstances under which they were made, not misleading. The
financial statements of the Company included in the Company's registration
statement on Form 20-F, dated January 19, 2005, comply as to form in all
material respects with applicable accounting requirements and the published
rules and regulations of the SEC or other applicable rules and regulations with
respect thereto. Such financial statements have been prepared in accordance with
generally accepted accounting principles applied on a consistent basis during
the periods involved (except (1) as may be otherwise indicated in such financial
statements or the notes thereto or (2) in the case of unaudited interim
statements, to the extent they may not include footnotes or may be condensed or
summary statements) and fairly present in all material respects the financial
position of the Company as of the dates thereof and the results of operations
and cash flows for the periods then ended (subject, in the case of unaudited
statements, to normal year-end audit adjustments).
(h) Since December 31, 2004, there has been no material adverse change
in the business, properties, operations, financial condition, or results of
operations of the Company.
(i) There is no fact known to the Company (other than general economic
conditions known to the public generally) or as disclosed in the Company's SEC
Documents that has not been disclosed in writing to the Buyer that (1) would
reasonably be expected to have an MAE or (2) would reasonably be expected to
have a material adverse effect the ability of the Company to perform its
obligations pursuant to this Agreement.
4. Certain Covenants and Acknowledgments. (a) The Buyer acknowledges that
(1) none of the Shares, the Warrant or the Warrant Shares have been registered
under the provisions of the 1933 Act, and none of them may be transferred unless
(A) subsequently registered thereunder, as provided for herein, or (B) the Buyer
shall have delivered to the Company and the Depositary, if required, an opinion
of counsel, reasonably satisfactory in form, scope and substance to the Company,
to the effect that the Shares, the Warrant or the Warrant Shares to be sold or
transferred may be sold or transferred pursuant to an exemption from such
registration, and (2) any sale of the Shares, the Warrant or Warrant Shares made
in reliance on Rule 144 promulgated under the 1933 Act may be made only in
accordance with the terms of said Rule and further, if said Rule is not
applicable, any resale of such securities under circumstances in which the
seller, or the person through whom the sale is made, may be deemed to be an
underwriter, as that term is used in the 1933 Act, may require compliance with
some other exemption under the 1933 Act or the rules and regulations of the SEC
thereunder.
(b) The Buyer acknowledges and agrees that until such time as the
Shares have been registered under the 1933 Act as contemplated hereby and sold
in accordance with an effective registration statement, the Shares shall bear a
restrictive legend in substantially the following form (and a stop-transfer
order may be placed against transfer of such Shares):
THESE SHARES (THE "SHARES") HAVE NOT BEEN REGISTERED UNDER THE SECURITIES
ACT OF 1933, AS AMENDED (THE "SECURITIES ACT"), OR THE SECURITIES LAWS OF
ANY STATE AND MAY NOT BE SOLD OR OFFERED
5
FOR SALE IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT FOR THE
SHARES OR AN OPINION OF COUNSEL OR OTHER EVIDENCE ACCEPTABLE TO THE
CORPORATION THAT SUCH REGISTRATION IS NOT REQUIRED.
(c) The Company shall make all necessary filings in connection with
the sale of the Shares and the Warrant to the Buyer under any United States laws
and regulations, or by any domestic securities exchange or trading market, and
to provide a copy thereof to the Buyer promptly after such filing.
(d) So long as the Buyer beneficially owns any of the Shares or any
Warrant Shares or the Warrant remains exercisable, the Company shall file all
reports required to be filed with the SEC pursuant to Rule 13a-16 or 15d-16 of
the 1934 Act, and the Company shall not terminate its status as an issuer
required to file reports under the 1934 Act even if the 1934 Act or the rules
and regulations thereunder would permit such termination.
5. Covenant to Register. (a) For purposes of this Section, the following
definitions shall apply:
"register," "registered," and "registration" refer to a registration under
the 1933 Act, effected by preparing and filing a registration statement or
similar document in compliance with the 1933 Act, and the declaration or
ordering of effectiveness of a Registration Statement, document or amendment
thereto.
"Registrable Securities" means the Shares, the Warrant Shares, and any
securities of the Company or securities of any successor corporation issued as
or issuable upon the conversion or exercise of any warrant, right or other
security that is issued as a dividend or other distribution with respect to, or
in exchange for, or in replacement of, the Shares and/or the Warrant Shares.
"holder of Registrable Securities" means the Buyer and any permitted
assignee of registration rights in accordance with this Agreement.
(b) Conditioned on compliance by each holder of Registrable Securities
with the provisions of this Agreement, including Section 5(f) hereof:
(i) the Company shall use reasonable efforts to promptly prepare
and file a registration statement on an appropriate form covering the sale by
all holders of Registrable Securities of such Registrable Securities (the
"Initial Registration Statement") and cause that registration statement to
become effective as soon as commercially reasonable, but no later than one
hundred eighty (180) days from the date of this Agreement;
(ii) the Company shall use reasonable efforts to keep the Initial
Registration Statement effective for so long as any holder of Registrable
Securities desires to dispose of the securities covered by the Initial
Registration Statement; provided, however, that in no event shall the Company be
required to keep the Initial Registration Statement effective for a period
greater than two (2) years from the date of this Agreement or, if earlier,
through such date
6
as all of the then-outstanding Registrable Securities can be sold within a given
three-month period or such date as all then-outstanding Registrable Securities
have been sold;
(iii) on no more then one (1) occasion after the Initial
Registration Statement has ceased to be effective and upon the request given by
not fewer than fifty percent (50%) of the aggregate number of Warrant Shares
then-outstanding or issuable upon the exercise of then-outstanding Warrants, the
Company shall use reasonable efforts to prepare and file a registration
statement on an appropriate form within ninety (90) days of such request
covering the sale by all such holders of such Warrant Shares (the "Demand
Registration Statement", each of the Initial Registration Statement and the
Demand Registration Statement are referred to herein as a "Registration
Statement") and cause that registration statement to become effective as soon as
commercially reasonable after such request; and
(iv) the Company shall use reasonable efforts to keep the Demand
Registration Statement effective for so long as any holder of Warrant Shares or
Warrants desires to dispose of the Warrant Shares covered by the Demand
Registration Statement; provided, however, that in no event shall the Company be
required to keep the Demand Registration Statement effective for a period
greater than one (1) year after it is declared effective or, if earlier, through
such date as all Warrant Shares can be sold within a given three-month period or
such date as all Warrant Shares have been sold.
(c) The Company may delay or suspend, without penalty, the
effectiveness of any registration pursuant to Section 5(b) in the event and for
such period of time (i) as such a delay or suspension is required in order to
comply with the rules and regulations of the SEC, or (ii) as commercially
reasonable or necessary in connection with a material event or occurrence
concerning the Company prior to the effectiveness of the initial registration
pursuant to Section 5(b). The Company will use reasonable efforts to cause any
such delay or suspension to terminate at the earliest possible date.
(d) If the Initial Registration Statement is not declared effective by
the SEC on or prior to one hundred eighty (180) days after the date of this
Agreement (the "Target Date"), unless delayed pursuant to Section 5(c), the
Company shall pay Buyer as liquidated damages an amount equal to one percent
(1%) of the total Purchase Price of the Shares and the Warrant for each thirty
(30) day period following the Target Date until such time as the Initial
Registration Statement is declared effective. Such payment shall be made to the
Buyer within ninety (90) days of the date due by cashier's check or wire
transfer in immediately available funds to such account as shall be designated
in writing by the Buyer.
(e) Whenever required under this Section 5 to effect the registration
of any Registrable Securities, the Company shall, as promptly as reasonably
possible:
(i) prepare and file with the SEC such amendments and supplements
to a Registration Statement and the prospectus used in connection with a
Registration Statement as may be necessary to comply with the provisions of the
1933 Act with respect to the disposition of all securities covered by such
Registration Statement and notify the holders of the filing and effectiveness of
such Registration statement and any amendments or supplements;
7
(ii) furnish to each holder of Registrable Securities such number
of copies of a current prospectus, including a preliminary prospectus,
conforming with the requirements of the 1933 Act, copies of the applicable
Registration Statement and any amendment or supplement to any thereof and any
documents incorporated by reference therein, and such other documents as such
holder of Registrable Securities may reasonably require in order to facilitate
the disposition of Registrable Securities owned by such holder of Registrable
Securities;
(iii) use reasonable efforts to register and qualify the
securities covered by a Registration Statement under such other securities or
"Blue Sky" laws of such jurisdictions as shall be reasonably requested in
writing by the holder of Registrable Securities; provided however that the
Company shall not be required to qualify to do business or consent to service of
process in any jurisdiction in which it is not now so qualified or has not so
consented; and
(iv) notify each holder of Registrable Securities reasonably
promptly of the happening of any event as a result of which the prospectus
included in a Registration Statement, as then in effect, includes an untrue
statement of material fact or omits to state a material fact required to be
stated therein or necessary to make the statements therein not misleading in
light of the circumstances then existing, and use its reasonable efforts to
promptly update and/or correct such prospectus.
(f) Upon request of the Company, each holder of Registrable Securities
will furnish to the Company in connection with any registration under this
Section such information regarding itself, the Registrable Securities and other
securities of the Company held by it, and the intended method of disposition of
such securities as shall be reasonably required to effect the registration of
the Registrable Securities held by such holder of Registrable Securities. Each
such holder shall promptly notify the Company of any changes in any such
information.
(g) To the fullest extent permitted by law, the Company shall
indemnify, defend and hold harmless each holder of Registrable Securities that
are included in a Registration Statement and each of its officers, directors,
employees, agents, partners or controlling persons (within the meaning of the
1933 Act) (each, an "indemnified party") from and against, and shall reimburse
such indemnified party with respect to, any and all claims, suits, demands,
causes of action, losses, damages, liabilities, costs or expenses
("Liabilities") to which such indemnified party may become subject under the
1933 Act or otherwise, arising from or relating to (A) any untrue statement or
alleged untrue statement of any material fact contained in a Registration
Statement, any prospectus contained therein or any amendment or supplement
thereto, or (B) the omission or alleged omission to state therein a material
fact required to be stated therein or necessary to make the statements therein,
in light of the circumstances in which they were made, not misleading; provided,
however, that the Company shall not be liable in any such case to the extent
that any such Liability arises out of or is based upon an untrue statement or
omission or alleged untrue statement or omission so made in strict conformity
with information furnished by such indemnified party in writing specifically for
use in a Registration Statement.
(h) In the event of any registration under the 1933 Act of Registrable
Securities, each holder of such Registrable Securities hereby severally agrees
to indemnity,
8
defend and hold harmless the Company, and its officers, directors, employees,
agents, partners, or controlling persons (within the meaning of the 1933 Act)
(each, an "indemnified party") from and against, and shall reimburse such
indemnified party with respect to, any and all Liabilities to which such
indemnified party may become subject under the 1933 Act or otherwise, arising
from or relating to (A) any untrue statement or alleged untrue statement of any
material fact contained in a Registration Statement, any prospectus contained
therein or any amendment or supplement thereto, or (B) the omission or alleged
omission to state therein a material fact required to be stated therein or
necessary to make the statements therein, in light of the circumstances in which
they were made, not misleading; provided, that such holders will be liable in
any such case to the extent and only to the extent, that any such Liability
arises out of or is based upon an untrue statement or alleged untrue statement
or omission or alleged omission made in a Registration Statement, prospectus or
amendment or supplement thereto in reliance upon and in conformity with written
information furnished by such holder specifically for use in the preparation
thereof, and such Liability may in no event exceed the value of the Registrable
Securities so registered.
(i) Promptly after receipt by any indemnified party of notice of the
commencement of any action, such indemnified party shall, if a claim in respect
thereof is to be made against another party (the "indemnifying party")
hereunder, notify such party in writing thereof, but the omission so to notify
such party shall not relieve such party from any Liability which it may have to
the indemnified party other than under this Section and shall only relieve it
from any Liability which it may have to the indemnified party under this Section
if and to the extent an indemnifying party is materially prejudiced by such
omission. In case any such action shall be brought against any indemnified party
and such indemnified party shall notify an indemnifying party of the
commencement thereof, the indemnifying party shall be entitled to participate in
and, to the extent it shall wish, to assume and undertake the defense thereof
with counsel reasonably satisfactory to such indemnified party, and, after
notice from the indemnifying party to the indemnified party of its election so
to assume and undertake the defense thereof, the indemnifying party shall not be
liable to the indemnified party under this Section for any legal expenses
subsequently incurred by the indemnified party in connection with the defense
thereof other than reasonable costs of investigation and of liaison with counsel
so selected; provided, however, that if the defendants in any such action
include both parties and the indemnified party shall have reasonably concluded
that there are reasonable defenses available to them which are different from or
additional to those available to the indemnifying party or if the interests of
the indemnified party reasonably are deemed to conflict with the interests of
the indemnifying party, the indemnified party shall have the right to select a
separate counsel and to assume such legal defenses and otherwise to participate
in the defense of such action, with the reasonable expenses and fees of one such
separate counsel and other reasonable expenses related to such participation to
be reimbursed by the indemnifying party as incurred.
(j) With respect to the inclusion of Registrable Securities in a
Registration Statement, all fees, costs and expenses of and incidental to such
registration, inclusion and public offering shall be borne by the Company;
provided, however, that any security holders participating in such registration
shall bear their pro-rata share of the underwriting discounts and commissions,
if any, incurred by them in connection with such registration. The fees, costs
and expenses of registration to be borne by the Company as provided in this
Section 5(j) shall include, without limitation, all registration, filing and
NASD fees, printing expenses, fees and
9
disbursements of counsel and accountants for the Company, and all legal fees and
disbursements and other expenses of complying with state securities or Blue Sky
laws of any jurisdiction or jurisdictions in which securities to be offered are
to be registered and qualified. Subject to appropriate agreements as to
confidentiality, the Company shall make available to the holders of Registrable
Securities and their counsel its documents and personnel for due diligence
purposes, provided that the fees and disbursements of counsel and accountants
for the selling security holders shall be borne by the respective selling
security holders.
(k) The rights to cause the Company to register all or any portion of
Registrable Securities pursuant to this Section 5 may be assigned by Buyer to a
proper transferee or assignee as described herein. Within a reasonable time
after such transfer, the Buyer shall notify the Company of the name and address
of such transferee or assignee, and the securities with respect to which such
registration rights are being assigned. Such assignment shall be effective only
if (1) the Buyer agrees in writing with the transferee or assignee to assign
such rights, and a copy of such agreement is furnished to the Company within a
reasonable time after such transfer or assignment (subject to the purchase price
of the Shares being kept confidential by the Buyer and such transferee or
assignee), (2) the Company is, within a reasonable time after such transfer or
assignment, furnished with written notice of (A) the name and address of such
transferee or assignee, and (B) the Registrable Securities with respect to which
such registration rights are being assigned, (3) following such transfer or
assignment, the further disposition of the Registrable Securities by the
transferee or assignee is restricted under the 1933 Act and applicable state
securities laws, (4) at or before the time that the Company receives the written
notice contemplated by clause (2) of this sentence the transferee or assignee
agrees in writing with the Company to be bound by all of the provisions
contained herein, (5) such transfer shall have been made in accordance with the
applicable requirements of the purchase agreement covering the transaction and
(6) such transferee shall be an "accredited investor", as that term is defined
in Rule 501 of Regulation D, promulgated under the 1933 Act.
6. Governing Law; Miscellaneous. The laws of the State of New York govern
all matters (including without limitation all tort claims) arising out of this
agreement. A facsimile transmission of this signed Agreement shall be legal and
binding on all parties hereto. This Agreement may be signed in one or more
counterparts, each of which shall be deemed an original. The headings of this
Agreement are for convenience of reference and shall not form part of, or affect
the interpretation of, this Agreement. If any provision of this Agreement shall
be invalid or unenforceable in any jurisdiction, such invalidity or
unenforceability shall not affect the validity or enforceability of the
remainder of this Agreement or the validity or enforceability of this Agreement
in any other jurisdiction. This Agreement may be amended only by an instrument
in writing signed by the party to be charged with enforcement. This Agreement
supersedes all prior agreements and understandings among the parties hereto with
respect to the subject matter hereof.
7. Notices. (a) For a notice or other communication under this agreement to
be valid, it must be in writing and signed by the sending party, and the sending
party must use one of the following methods of delivery: (1) personal delivery;
(2) internationally recognized courier, with all fees prepaid; or (3) facsimile.
10
(b) For a notice or other communication under this agreement to be
valid, it must be addressed to the receiving party at the one or more addresses
listed below for the receiving party or to any other address designated by the
receiving party in a notice in accordance with this Section 7.
To the Company: pSivida Limited
Level 12, BGC Centre
28 The Esplanade
Perth, WA 6000
Australia
Attention: Gavin Rezos, Managing Director
Fax: +61 (8) 9226 5499
With a copy to:
Curtis, Mallet-Prevost, Colt & Mosle LLP
101 Park Avenue
New York, NY 10178-0061
Attention: Lawrence Goodman
Fax: (212) 697-1559
To the Buyer: At the contact information stated
on the signature page of this Agreement
(c) Subject to Section 7(d), a valid notice or other communication
under this agreement is effective when received or deemed to be received by the
receiving party. A notice or other communication is deemed to have been received
as follows:
(i) if it is delivered in person or sent by registered or
certified mail or by nationally recognized overnight courier, upon receipt as
indicated by the date on the signed receipt;
(ii) if it is sent by facsimile, upon receipt by the sending
party of an acknowledgment or transmission report generated by the machine from
which the facsimile was sent indicating that the entire facsimile was sent to a
machine at the receiving party's facsimile number; and
(iii) if the receiving party rejects or otherwise refuses to
accept it, or if it cannot be delivered because of a change in address for which
no notice was given, then upon that rejection, refusal, or inability to deliver.
(d) If a notice or other communication is received after 5:00 p.m. on
a business day at the location specified in the address for the receiving party,
or on a day that is not a business day, then the notice is deemed received at
9:00 a.m. on the next business day.
11
8. Successors and Assigns. This Agreement shall be binding upon and inure
to the benefit of the parties hereto and their respective successors and
permitted assigns.
This Agreement is being signed on the date stated below.
For the purchase price of $__________ per Share, the Buyer tenders herewith
the full purchase price of US$______________ for _____________ Shares and the
Warrant to purchase _____________ Warrant Shares.
BUYER:
----------------------------------------
Print Name
----------------------------------------
Signature
----------------------------------------
Name and title of signatory, if
different from name of Buyer
----------------------------------------
----------------------------------------
----------------------------------------
Address
Fax number:
----------------------------
----------------------------------------
If Buyer is an entity, jurisdiction
of organization and type of entity
This Agreement is being accepted as of August __, 2005.
PSIVIDA LIMITED
By:
------------------------------------
Gavin Rezos
Managing Director
12
EXHIBIT A
FORM OF WARRANT
Exhibit 4.3
THIS WARRANT AND ANY SHARES ISSUABLE UPON EXERCISE OF THIS WARRANT HAVE NOT BEEN
REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR THE SECURITIES LAWS
OF ANY STATE AND MAY NOT BE SOLD OR OFFERED FOR SALE IN THE ABSENCE OF AN
EFFECTIVE REGISTRATION STATEMENT OR AN OPINION OF COUNSEL OR OTHER EVIDENCE
ACCEPTABLE TO PSIVIDA LIMITED THAT REGISTRATION IS NOT REQUIRED.
FORM OF PSIVIDA LIMITED
WARRANT AGREEMENT
VOID AFTER 5:00 P.M. NEW YORK TIME, SEPTEMBER 9, 2008
Issue Date: September 9, 2005
1. Basic Terms. This warrant agreement (this "Warrant") certifies that, for
value received, the registered holder specified below or its registered assigns
(the "Holder") is the owner of a warrant of pSivida Limited, an Australian
company having its principal place of business at Level 12, BGC Centre, 28 The
Esplanade, Perth, WA 6000, Australia (the "Company"), subject to adjustments as
provided herein, to purchase ________________ American Depositary Shares of the
Company (the "Warrant Shares"), each representing ten ordinary shares of the
Company, from the Company at the price per share shown below (the "Exercise
Price").
Holder: ______________________________
Exercise Price per share: ______________________________
Except as specifically provided otherwise, all references in this Warrant to the
Exercise Price and the number of Warrant Shares purchasable hereunder are to the
Exercise Price and number of Warrant Shares after any adjustments are made
thereto pursuant to this Warrant.
2. Shares Issuable. The Company represents that the Warrant Shares issuable
upon the exercise of this Warrant will at delivery be fully paid and
non-assessable and free from taxes, liens, encumbrances and charges with respect
to their purchase. The Company shall at all times reserve and hold available
sufficient shares to satisfy all conversion and purchase rights of outstanding
convertible securities, options and warrants of the Company, including this
Warrant.
3. Method of Exercise; Fractional Shares. This Warrant is exercisable at
the option of the Holder at any time by surrendering this Warrant, on any
business day during
the period (the "Exercise Period") beginning the business day after the issue
date of this Warrant specified above and ending at 5:00 p.m. (New York time)
three years after the issue date. This Warrant may not be exercised for fewer
than 5,000 Warrant Shares per exercise, as adjusted to reflect stock dividends,
stock splits, and other comparable changes. To exercise this Warrant, the Holder
shall surrender this Warrant at the principal office of the Company or that of
the Company's Depositary, together with the executed exercise form
(substantially in the form of that attached hereto) and together with payment
for the Warrant Shares purchased under this Warrant. Payment shall be made by
check payable to the order of the Company or by wire transfer. Promptly after
exercise, the Company shall deliver to the Company's Depositary a binding and
irrevocable instruction letter instructing the Depositary to issue to the Holder
an American Depositary Receipt representing the Warrant Shares issuable in
connection with that exercise. This Warrant is not exercisable with respect to a
fraction of a Warrant Share. In lieu of issuing a fraction of a share remaining
after exercise of this Warrant as to all full shares covered by this Warrant,
the Company shall either at its option (a) pay for the fractional share cash
equal to the same fraction at the fair market price for such share; or (b) issue
scrip for the fraction in the registered or bearer form entitling the Holder to
receive a certificate for a full American Depositary Share on surrender of scrip
aggregating a full share.
4. Protection Against Dilution. Subject to the Listing Rules of Australian
Stock Exchange Limited, the number of Warrant Shares purchasable under this
Warrant, and the Exercise Price, shall be adjusted as set forth as follows. If
at any time or from time to time after the date of this Warrant, the Company:
(i) takes a record of the holders of its outstanding ordinary shares
or American Depositary Shares for the purposes of entitling them
to receive a dividend payable in, or other distribution of,
ordinary shares or American Depositary Shares; or
(ii) subdivides its outstanding ordinary shares or American Depositary
Shares into a larger number of ordinary shares or American
Depositary Shares; or
(iii) combines its outstanding ordinary shares or American Depositary
Shares into a smaller number of ordinary shares or American
Depositary Shares;
then, and in each such case, the Exercise Price shall be adjusted to that price
determined by multiplying the Exercise Price in effect immediately prior to such
event by a fraction (A) the numerator of which is the total number of
outstanding ordinary shares or American Depositary Shares (as applicable)
immediately prior to such event and (B) the denominator of which is the total
number of outstanding ordinary shares or American Depositary Shares (as
applicable) immediately after such event.
Upon each adjustment in the Exercise Price under this Warrant the number of
Warrant Shares purchasable under this Warrant will be adjusted by multiplying
the number of
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Warrant Shares by a fraction, the numerator of which is the Exercise Price
immediately prior to such adjustment and the denominator of which is the
Exercise Price in effect upon such adjustment.
5. Adjustment for Reorganization, Consolidation, Merger, Etc.
(a) During the Exercise Period, the Company shall, prior to
consummation of a consolidation with or merger into another corporation, or
conveyance of all or substantially all of its assets to any other corporation or
corporations, whether affiliated or unaffiliated (any such corporation being
included within the meaning of the term "successor corporation"), or entry into
any agreement to so consolidate, merge or convey assets, require the successor
corporation to assume, by written instrument delivered to the Holder, the
obligation to issue and deliver to the Holder such shares of stock, securities
or property as, in accordance with the provisions of Section 5(b), the Holder is
entitled to purchase or receive.
(b) In the event of any capital reorganization or reclassification of
the stock of the Company (or any other corporation the stock or other securities
of which are at the time receivable on the exercise of this Warrant) during the
Exercise Period, or in the event that during the Exercise Period the Company (or
any such other corporation) consolidates with or merges into another corporation
or conveys all or substantially all its assets to another corporation, the
Holder, upon exercise, at any time after the consummation of such
reorganization, consolidation, merger or conveyance, will be entitled to
receive, in lieu of Warrant Shares (or stock of such other corporation), the
proportionate share of all stock, securities or other property issued, paid or
delivered for or on all of the stock of the Company (or such other corporation)
as is allocable to the Warrant Shares then called for by this Warrant as if the
Holder had exercised the Warrant immediately prior thereto, all subject to
further adjustment as provided in Section 4.
6. Notice of Adjustment. On the happening of an event requiring an
adjustment of the Exercise Price or the shares purchasable under this Warrant,
the Company shall immediately give written notice to the Holder stating the
adjusted Exercise Price and the adjusted number and kind of securities or other
property purchasable under this Warrant resulting from the event and setting
forth in reasonable detail the method of calculation and the facts upon which
the calculation is based.
7. Dissolution, Liquidation. In case of the voluntary or involuntary
dissolution, liquidation or winding up of the Company (other than in connection
with a reorganization, consolidation, merger, or other transaction covered in
Section 5) is at any time proposed, the Company shall give at least thirty days'
prior written notice to the Holder. Such notice shall contain the following: (a)
the date on which the transaction is to take place; (b) the record date (which
shall be at least thirty days after the giving of the notice) as of which
holders of Common Stock will be entitled to receive distributions as a result of
the transaction; (c) a brief description of the transaction, (d) a brief
description of the distributions to be made to holders of ordinary shares of the
Company as a result of the transaction; and (e) an estimate of the fair value of
the distributions. On the date of
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the transaction, if it actually occurs, this Warrant and all rights under this
Warrant will terminate.
8. Rights of Holder. The Company shall deliver to the Holder all notices
and other information provided to holders of ordinary shares of the Company or
other securities issuable under this Warrant concurrently with the delivery of
such information to those holders. This Warrant does not entitle the Holder to
any voting rights or, except for the foregoing notice provisions, any other
rights as a shareholder of the Company. No dividends are payable or will accrue
on this Warrant or the Warrant Shares purchasable under this Warrant until, and
except to the extent that, this Warrant is exercised. Upon surrender of this
Warrant and payment of the Exercise Price as provided above, the person or
entity entitled to receive the Warrant Shares issuable upon such exercise shall
be treated for all purposes as the record holder of such shares as of the close
of business on the date of the surrender of this Warrant for exercise as
provided above. Upon the exercise of this Warrant, the Holder will have all of
the rights of a shareholder in the Company.
9. Exchange for Other Denominations. This Warrant is exchangeable, on its
surrender by the Holder to the Company, for a new Warrant of like tenor and date
representing in the aggregate the right to purchase the balance of the number of
shares purchasable under this Warrant in denominations and subject to
restrictions on transfer contained herein, in the names designated by the Holder
at the time of surrender.
10. Substitution. Upon receipt by the Company of evidence satisfactory (in
the exercise of reasonable discretion) to it of the ownership of and the loss,
theft or destruction or mutilation of the Warrant, and (in the case or loss,
theft or destruction) of indemnity satisfactory (in the exercise of reasonable
discretion) to it, and (in the case of mutilation) upon the surrender and
cancellation thereof, the Company will issue and deliver, in lieu thereof, a new
Warrant of like tenor.
11. Restrictions on Transfer; Registration Rights. Neither this Warrant nor
the Warrant Shares issuable on exercise of this Warrant have been registered
under the Securities Act of 1933, as amended, or any other securities laws (the
"Acts"). Neither this Warrant nor the Warrant Shares purchasable hereunder may
be sold, transferred, pledged or hypothecated in the absence of (a) an effective
registration statement for this Warrant or the American Depositary Shares
purchasable hereunder under the Acts, or (b) an opinion of counsel reasonably
satisfactory to the Company that registration is not required under the Acts.
Transfer of this Warrant and the Warrant Shares is further subject to the terms
of the Securities Purchase Agreement between the Holder and the Company dated
the date of this Warrant. If the Holder seeks an opinion as to transfer without
registration from Holder's counsel, the Company shall provide such factual
information to Holder's counsel as Holder's counsel reasonably requests for the
purpose of rendering such opinion. Any certificate evidencing Warrant Shares
purchased hereunder will bear a legend describing the restrictions on transfer
contained in this Section 11 unless, in the opinion of counsel reasonably
acceptable to the Company, the shares need no longer to be subject to the
transfer restrictions.
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12. Transfer. Except as otherwise provided in this Warrant, this Warrant is
transferable only on the books of the Company by the Holder in person or by
attorney, on surrender of this Warrant, properly endorsed.
13. Recognition of Holder. Prior to due presentment for registration of
transfer of this Warrant, the Company shall treat the Holder as the person
exclusively entitled to receive notices and otherwise to exercise rights under
this Warrant. All notices required or permitted to be given to the Holder shall
be in writing and shall be given by first class mail, postage prepaid, addressed
to the Holder at the address of the Holder appearing in the records of the
Company.
14. Payment of Taxes. The Company shall pay all taxes and other
governmental charges, other than applicable income taxes, that may be imposed
with respect to the issuance of Warrant Shares pursuant to the exercise of this
Warrant.
15. Headings. The headings in this Warrant are for purposes of convenience
in reference only, shall not be deemed to constitute a part of this Warrant, and
shall not affect the meaning or construction of any of the provisions of this
Warrant.
16. Miscellaneous. This Warrant may not be changed, waived, discharged or
terminated except by an instrument in writing signed by the Company and the
Holder. This Warrant shall inure to the benefit of and shall be binding upon the
successors and assigns of the Company. Under no circumstances may this Warrant
be assigned by the Holder.
17. Governing Law. This Warrant shall be governed by and construed in
accordance with the laws of the State of New York without giving effect to its
principles governing conflicts of law.
PSIVIDA LIMITED
By:
------------------------------------
Gavin Rezos
Managing Director
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PSIVIDA LIMITED
FORM OF TRANSFER
(To be executed by the Holder to transfer the Warrant)
For value received the undersigned registered holder of the attached Warrant
hereby sells, assigns, and transfers the Warrant to the Assignee(s) named below:
Number of Shares
Subject to
Names of Assignee Address Taxpayer ID No. Transferred Warrant
- ----------------- ------- --------------- -------------------
The undersigned registered holder further irrevocably appoints _________________
___________________________________ attorney (with full power of substitution)
to transfer this Warrant as aforesaid on the books of the Company.
Date:
----------------------- ----------------------------------------
Signature
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PSIVIDA LIMITED
EXERCISE FORM
(To be executed by the Holder to purchase
American Depositary Shares pursuant to the Warrant)
The undersigned holder of the attached Warrant hereby: (1) irrevocably elects to
exercise purchase rights represented by such Warrant for, and to purchase,
___________ American Depositary Shares of pSivida Limited, an Australian
company, and encloses a check or has wired payment of $_________________________
therefor; (2) requests that an American Depositary Receipt representing those
American Depositary Shares be issued in the name of the undersigned; and (3) if
such number of shares is not all of the shares purchasable under this Warrant,
that a new Warrant of like tenor for the balance of the remaining shares
purchasable under this Warrant be issued.
Date:
----------------------- ----------------------------------------
Signature
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CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the incorporation by reference in this Registration
Statement on Form F-3 of our report dated December 2, 2005 relating to the
financial statements which appears in pSivida Limited's Form 6-K for the year
ended December 31, 2004. We also consent to the references to us under the
headings "Experts" in such Registration Statement.
/s/ PricewaterhouseCoopers LLP
PricewaterhouseCoopers LLP
Boston, Massachusetts
March 24, 2006
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the incorporation by reference in this Registration
Statement on Form F-3 of our report dated December 14, 2005 (January 12, 2006 as
to Note 19), relating to the financial statements of pSivida Limited appearing
in the Annual Report on Form 20-F of pSivida Limited for the year ended June 30,
2005 and to the reference to us under the heading "Experts" in the Prospectus,
which is part of this Registration Statement.
/s/ Deloitte Touche Tohmatsu
DELOITTE TOUCHE TOHMATSU
Perth, Australia
March 28, 2006
CORRESP
VIA EDGAR TRANSMISSION
March 28, 2006
SEC Headquarters
100 F Street, NE
Washington, DC 20549
Office of Investor Education and Assistance
Re: pSivida Limited
Registration Statement on Form F-3
Ladies and Gentlemen:
On behalf of pSivida Limited (the Company), we respectfully submit this
registration statement on Form F-3 that registers the resale of 5,665,000
ordinary shares represented by 566,500 American Depositary Shares (ADSs). By
means of a private placement, we sold 515,000 ADSs to the selling shareholders
named in the registration statement together with warrants to acquire up to
51,500 additional ADSs.
Please note that the Company has simultaneously filed a registration statement
on Form F-3 that registers the resale of 4,869,252 ADSs by the holder of a
subordinated convertible promissory note and warrant issued in a separate
private placement. The Company also expects to file a third registration
statement on Form F-3 to register the resale of 159,836,610 ordinary Shares
represented by 15,983,661 ADSs issued pursuant to the acquisition of Control
Delivery Systems, Inc. by the Company.
Please be advised that the Company anticipates making an oral request for
acceleration of effectiveness of this registration statement pursuant to Rule
461 under the Securities Act of 1933 (the Securities Act). In that regard,
this letter confirms that the Company is aware of its obligations under the
Securities Act as they relate to the offering of shares described in this
registration statement.
Please call me at (212) 696-8880 if you have any questions about this filing.
We would very much appreciate the staffs assistance in declaring this
registration statement effective as soon as possible.
Very truly yours,
Curtis, Mallet-Prevost, Colt & Mosle LLP
/s/ Peter F. Stewart
Peter F. Stewart