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UNDER
THE SECURITIES ACT OF 1933
Western Australia, | 2834 | Not Applicable | ||
Commonwealth of Australia | ||||
(State or other jurisdiction of | (Primary Standard Industrial | (I.R.S. Employer | ||
incorporation or organization) | Classification Code Number) | Identification No.) |
28 The Esplanade
Perth WA 6000
Australia
61 (8) 9226 5099
(Address, including zip code, and telephone number, including area code, of Registrant’s principal executive offices)
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)
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Title of Each Class of | Proposed Maximum Offering | Proposed Maximum | Amount of Registration | |||||||||||
Securities to be Registered (1) | Amount to be Registered (2) | Price Per Share | Aggregate Offering Price | Fee | ||||||||||
Ordinary Shares underlying subordinated convertible note | 40,453,080 | $0.515(3) | $20,633,333(4) | $2,209 | ||||||||||
Ordinary Shares underlying warrant | 8,239,440 | $0.72(4) | $5,932,397(5) | $635 | ||||||||||
(1) | 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. | |
(2) | Please refer to the “Selling Security Holder” section of the prospectus that is a part of this Registration Statement for a description of what comprises the ordinary shares being registered. In accordance with Rule 416(a), the Registrant is also registering hereunder an indeterminate number of ordinary shares that may be issued and resold to prevent dilution resulting from stock splits, stock dividends or similar transactions. | |
(3) | The average of the high and low prices of the Registrant’s ADSs on March 22, 2006 as reported on the NASDAQ National Market. | |
(4) | Estimated solely for the purposes of calculating the registration fee pursuant to Rule 475(o) of the Securities Act. | |
(5) | 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. |
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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.
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• | Biocompatibility – BioSilicon is biocompatible, meaning, it is not injurious and does not cause |
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immunological rejection within the body. |
• | 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. | ||
• | Biodegradability – BioSilicon can be made biodegradablein vivo(in animals and humans) andin 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. |
• | 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, pSivida’s lead product, based upon market sizes, benefits offered to patients and alternative competitive therapies. | ||
• | 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. | ||
• | 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. | ||
• | 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. |
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• | inability to attract clinical investigators for trials; | ||
• | inability to recruit patients in sufficient numbers or at the expected rate; | ||
• | adverse side effects; | ||
• | failure of the trials to demonstrate a product’s safety or efficacy; | ||
• | 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; | ||
• | changes in the design or manufacture of a product; | ||
• | inability to manufacture sufficient quantities of materials for use in clinical trials; and | ||
• | governmental or regulatory delays. |
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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; | ||
• | 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; | ||
• | our collaborators may develop and commercialize, either alone or with others, products that are similar to or competitive with our products; | ||
• | 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 related to such products; and | ||
• | our collaborators may lack the funding or experience to develop and commercialize our products successfully or may otherwise fail to do so. |
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• | create and maintain scientifically-advanced technology and proprietary products and processes; | ||
• | attract and retain qualified personnel; | ||
• | develop safe and efficacious products, alone or in collaboration with others; | ||
• | obtain patent or other protection for our products and processes; | ||
• | obtain required government approvals on a timely basis; | ||
• | manufacture products on a cost-effective basis; and | ||
• | successfully market products. |
• | managing foreign distributors; | ||
• | staffing and managing foreign operations; | ||
• | political and economic instability; |
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• | foreign currency exchange fluctuations; | ||
• | foreign tax laws, tariffs and freight rates and charges; | ||
• | timing and availability of export licenses; | ||
• | inadequate protection of intellectual property rights in some countries; and | ||
• | obtaining required governmental approvals. |
• | the possibility that third parties may not comply with the FDA’s current good manufacturing practices, regulations, other regulatory requirements, and those of similar foreign regulatory bodies, and employ adequate quality assurance practices; | ||
• | supply disruption, deterioration in product quality or breach of a manufacturing or license agreement by the third party because of factors beyond CDS’ control; | ||
• | 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 | ||
• | inability to identify or qualify an alternative manufacturer in a timely manner, even if contractually permitted to do so. |
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• | the accuracy of the assumptions underlying our estimates for our capital needs in the near and long term; | ||
• | continued scientific progress in our research and development programs; | ||
• | the magnitude and scope of our research and development programs; | ||
• | our ability to maintain and establish strategic arrangements for research, development, clinical testing, manufacturing and marketing; | ||
• | our progress with preclinical and clinical trials; | ||
• | 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. |
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• | 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. |
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• | 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. |
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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 |
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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 convertible 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 | ||||||||||||||||
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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 |
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(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 $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 | |||||||
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(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 pSivida’s 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. |
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(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 pSivida’s 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. |
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(in Australian dollars)
5. | Loss per share | |
Pro forma per share data is based on the number of shares of pSivida’s 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. |
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Maximum Number of Ordinary | ||||||||||||
Shares to be Sold Pursuant to | ||||||||||||
Number of Ordinary Shares | this Prospectus | Number of Ordinary Shares | ||||||||||
Name of Selling Security Holder | Owned Prior to Offering (1) | (2)(3) | Owned After Offering | |||||||||
Castlerigg Master Investments (4) | 2,936,621 | 4,869,252 | — |
(1) | The number of shares beneficially owned is determined in accordance with Rule 13d-3 of the Exchange Act, and the information is not necessarily indicative of beneficial ownership for any other purpose. Under such rule, beneficial ownership includes any shares as to which an individual has sole or shared voting power or investment power and also any shares which an individual has the right to acquire within 60 days of the date of this prospectus through the exercise of any stock option or other right. The shares listed in this column include shares underlying the note and shares underlying the warrant acquired in November 2005, in each case, which the selling security holder has the right to acquire within 60 days of March 22, 2006 assuming a conversion price of $7.10. The shares listed in this column do not reflect the 4.99% ownership limitation noted above. Unless otherwise indicated, the selling security holder has sole voting and investment power with respect to the ordinary shares it holds through its ADSs. The inclusion of any ordinary shares in this table does not constitute an admission of beneficial ownership for the selling security holder. |
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(2) | Assumes the full conversion of the selling security holder’s note and interest payments due after April 1, 2006 at a conversion price of $5.15 and the full exercise of the selling security holder’s warrant. Pursuant to Rule 416 of the Securities Act, this registration statement also shall cover any additional ordinary shares that become issuable in connection with the ordinary shares registered for sale hereby by reason of any stock dividend, stock split, recapitalization or other similar transaction effected without the receipt of consideration that results in an increase in the number of our outstanding ordinary shares. | |
(3) | The number of ordinary shares to be sold by the selling security holder is based on 130% of the estimated number of our ordinary shares issuable to the selling security holder upon conversion of the note and upon exercise of the related warrant (assuming for purposes of such calculation, that the note and warrant were converted or exercised at a conversion price of $5.15). | |
(4) | Sandell Asset Management Corp. (“SAMC”), is the investment manager of Castlerigg Master Investments Ltd. (“Master”). Thomas Sandell is the controlling person of SAMC and may be deemed to share beneficial ownership of the shares beneficially owned by Master. Castlerigg International Ltd. (“Castlerigg International”) is the controlling shareholder of Castlerigg International Holdings Limited (“Holdings”). Holdings is the controlling shareholder of Master. Each of Holdings and Castlerigg International may be deemed to share beneficial ownership of the shares beneficially owned by Castlerigg Master Investments. SAMC, Mr. Sandell, Holdings and Castlerigg International each disclaims beneficial ownership of the securities with respect to which indirect beneficial ownership is described. |
• | 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; | ||
• | broker-dealers may agree with the selling security holder to sell a specified number of such ADSs at a stipulated price per ADS; |
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• | a combination of any such methods of sale; and | ||
• | any other method permitted pursuant to applicable law. |
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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 |
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 |
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 |
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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 |
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 |
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SEC Registration Fees | $ | 2,844 | ||
Transfer Agent Fees | $ | 194,770 | ||
Legal Fees and Expenses | $ | 75,000 | ||
Accounting Fees | $ | 15,000 | ||
Miscellaneous (including EDGAR filing costs) | $ | 5,000 | ||
Total | $ | 292,614 | ||
• | 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 November 15, 2005; | ||
• | Our report on Form 6-K furnished to the SEC on December 22, 2005; | ||
• | 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; |
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• | 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. |
Vice President for Corporate Affairs, General Counsel and Secretary
pSivida Inc.
400 Pleasant Street
Watertown, MA 02472
Telephone: (617) 926-5000
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• | 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. |
• | in defending or resisting proceedings in which the person is found to have a liability for which they could not be indemnified under |
• | 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 |
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• | in connection with proceedings for relief to the person under the Corporations Act in which the court denies the relief. |
• | conduct involving a willful breach of any duty in relation to the company; or | |
• a contravention of the officer’s duties under the Corporations Act not to improperly use their position or make improper use of information obtained as an officer. |
• | 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 company’s financial standing; and | |
• | a person in accordance with whose instructions or wishes the directors of the company are accustomed to act. |
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 | Securities Purchase Agreement, dated October 5, 2005, between pSivida Limited and the investor listed on the Schedule of Buyers attached thereto (d) | |
4.3 | Form of Subordinated Convertible Note in the principal amount of US$15,000,000 (d)(e) | |
4.4 | Form of Warrant to Purchase ADRs for the purchase of up to 633,803 ADRs (d)(e) | |
4.5 | Form of Registration Rights Agreement (d)(e) | |
4.6 | Letter Agreement, dated November 15, 2005, relating to the Securities Purchase Agreement (d) | |
4.7 | Note Amendment Agreement, dated February 22, 2006, between pSivida Limited and Castlerigg Master Investments Ltd. (f) | |
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 27, 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 registrant’s filing on Form F-6 (Commission file number 333-122158) filed on January 19, 2005. | |
(c) | Incorporated by reference to the registrant’s 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) | Incorporated by reference to the registrant’s filing on Form 6-K (Commission file number 000-51122) filed on November 15, 2005. | |
(e) | 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 the participant in the convertible note sale. Such final versions are |
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(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; |
(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 initialbonafide 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 |
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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 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 registrant’s 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 plan’s 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 initialbona fideoffering thereof. |
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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 | |||
Name | Title | |
/s/ Roger Brimblecombe | Chairman of the Board of Directors, Non-Executive Director | |
�� | ||
/s/ Gavin Rezos | Chief Executive Officer and Managing Director (principal executive officer) | |
Name: Gavin Rezos | ||
/s/ David Mazzo | Director | |
/s/Aaron Finlay | Chief Financial Officer and Company Secretary (principal accounting officer) | |
/s/Paul Ashton | Director; Authorized Representative in the United States | |
/s/ Stephen Lake | Director | |
/s/ Michael W. Rogers | Director | |
/s/ Heather Zampatti | Director | |
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