U.S. SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 20-F
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REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR 12(g) |
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OF THE SECURITIES EXCHANGE ACT OF 1934 |
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OR |
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x |
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) |
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OF THE SECURITIES EXCHANGE ACT OF 1934 |
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For the fiscal year ended June 30, 2006 |
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OR |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) |
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OF THE SECURITIES EXCHANGE ACT OF 1934 |
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OR |
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SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) |
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OF THE SECURITIES EXCHANGE ACT OF 1934 |
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Date of event requiring this shell company report..... |
Commission file number 0-51504
GENETIC
TECHNOLOGIES LIMITED
(Exact Name of Registrant as Specified in its Charter)
Australia
(Jurisdiction of Incorporation or Organization)
N/A
(Translation of Registrant’s name into English)
60-66 Hanover Street, Fitzroy, Victoria, 3065, Australia
Telephone:
011 61 3 9415 1135; Facsimile: 011 61 3
9417 2987
(Address of principal executive offices)
Securities registered or to be registered pursuant to Section 12(b) of the Act
None
Securities registered pursuant to Section 12(g) of the Act:
Title of each class
American
Depositary Shares each representing 30 Ordinary Shares
and evidenced by American Depositary Receipts
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act:
None
The total number of issued shares of each class of stock of Genetic Technologies Limited as of June 30, 2006 was:
362,389,899 Ordinary Shares
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
Yes o No x
If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934.
Yes o No o
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes x No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer.
Large accelerated filer o Accelerated filer Non-accelerated filer x
Indicate by check mark which financial statement item the registrant has elected to follow.
Item 17 o Item 18 x
If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes o No x
Please send copies of notices and communications from the Securities and Exchange Commission to:
Ross Kaufman
Greenberg Traurig, LLP
200 Park Avenue
New York, New York 10166
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EXCHANGE CONTROLS AND OTHER LIMITATIONS AFFECTING SECURITY HOLDERS |
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MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS |
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ii
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PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS |
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iii
In this Annual Report, the “Company,” “Genetic Technologies”, “we,” “us” and “our” refer to Genetic Technologies Limited and its consolidated subsidiaries.
References to the “ADSs” are to our ADSs described in Item 12.D, “American Depositary Shares,” and references to the “Ordinary Shares” are to our Ordinary Shares described in Item 10.A, “Share Capital.”
Except as otherwise stated, all monetary amounts in this Annual Report are presented in U.S. dollars. Unless otherwise indicated, amounts in Australian dollars have been translated into U.S. dollars. These translations are provided for convenience only, and they are not representations that the Australian dollar could be converted into U.S. dollars at the rate indicated. Historic data has been converted at the applicable rate at the date indicated. In this Annual Report, references to “AUD” are to Australian dollars and references to “$” and “U.S. dollars” are to United States dollars. The noon buying rate for cable transfers in Australian dollars on June 30, 2005 was AUD1.00 = $0.7618 and on June 30, 2006 was AUD1.00 = $0.7423.
Our fiscal year ends on June 30, and references in this Annual Report to any specific fiscal year are to the twelve month period ended on June 30 of such year.
This Annual Report contains forward-looking statements that involve risks and uncertainties. We use words such an “anticipates”, “believes”, “plans”, “expects”, “future”, “intends” and similar expressions to identify such forward-looking statements. This Annual Report also contains forward-looking statements attributed to certain third parties relating to their estimates regarding the growth of Genetic Technologies and related service markets and spending. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this Annual Report. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including the risks faced by us described below under the caption “Risk Factors” and elsewhere in this Annual Report.
Although we believe that the expectations reflected in such forward-looking statements are reasonable at this time, we can give no assurance that such expectations will prove to be correct. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Important factors that could cause actual results to differ materially from our expectations are contained in cautionary statements in this Annual Report including, without limitation, in conjunction with the forward-looking statements included in this Annual Report and specifically under Item 3.D, “Risk Factors.”
All subsequent written and oral forward-looking statements attributable to us are expressly qualified in their entirety by reference to these cautionary statements.
ENFORCEMENT OF LIABILITIES AND SERVICE OF PROCESS
We are incorporated under the laws of Western Australia, in the Commonwealth of Australia. All of our directors and executive officers, and any experts named in this Annual Report, reside outside the U.S. Substantially all of our assets, our directors’ and executive officers’ assets and such experts’ assets are located outside the U.S. As a result, it may not be possible for investors to affect service of process within the U.S. upon us or our directors, executive officers or such experts, or to enforce against them or us in U.S. courts, judgments obtained in U.S. courts based upon the civil liability provisions of the federal securities laws of the U.S. In addition, we have been advised by our Australian solicitors that there is doubt that the courts of Australia will enforce against us, our directors, executive officers and experts named herein, judgments obtained in the U.S. based upon the civil liability provisions of the federal securities laws of the U.S. or will enter judgments in original actions brought in Australian courts based upon the federal securities laws of the U.S.
1
PART I
Item 1. Identity of Directors, Senior Management and Advisers
Item 1.A Directors and Senior Management
The Directors of the Company as of the date of this Annual Report are as follows:
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Name |
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Position/Function |
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Business Address |
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Henry Bosch AO |
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Chairman |
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60-66 Hanover Street |
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Dr. Mervyn Jacobson |
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Chief Executive Officer |
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60-66 Hanover Street |
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Fred Bart |
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Non-Executive Director |
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Suite 2, Level 12, 75 Elizabeth Street |
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John S. Dawkins AO |
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Non-Executive Director |
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60-66 Hanover Street |
The members of Senior Management of the Company as of the date of this Annual Report are as follows:
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Name |
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Position/Function |
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Business Address |
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Dr. Mervyn Jacobson |
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Chief Executive Officer |
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60-66 Hanover Street |
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Thomas G. Howitt |
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Chief Financial
Officer and |
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60-66 Hanover Street |
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Geoffrey E. Newing |
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Chief Operating Officer |
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60-66 Hanover Street |
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Dr. Gary S. Cobon |
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Chief Scientific Officer |
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60-66 Hanover Street |
2
Item 1.B Advisers
Our principal bankers, accountants and legal advisers are as follows:
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Name of Adviser |
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Function |
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Business Address |
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Ernst & Young |
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Auditors |
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8 Exhibition Street |
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St. George Bank Limited |
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Bankers - Australia |
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530 Collins Street |
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KeyBank National Association |
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Bankers - USA |
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1130 Haxton Drive |
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Baker & McKenzie |
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General Counsel |
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525 Collins Street |
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Hamilton & DeSanctis |
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Licensing Attorneys |
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8555 W. Belleview Avenue G21-139 |
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Faegre & Benson LLP |
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Patent Attorneys |
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3200 Wells Fargo Center |
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Greenberg Traurig, LLP |
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U.S. Securities Counsel |
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200 Park Avenue |
The auditors of the Company’s US GAAP accounts for the years ended June 30, 2002, 2003, 2004, 2005 and 2006 were Ernst & Young, whose address is 8 Exhibition Street, Melbourne, Victoria, 3000, Australia. Ernst & Young are the Company’s current auditors, an appointment ratified at the Annual General Meeting held on November 28, 2003.
Item 2. Offer Statistics And Expected Timetable
Not applicable.
Item 3.A Selected Financial Data
The following selected financial data for the five years ended June 30, 2006, respectively, is derived from the audited consolidated financial statements of Genetic Technologies Limited, prepared in accordance with United States generally accepted accounting principles (“US GAAP”). The data should be read in conjunction with the consolidated financial statements, related notes and other financial information included herein.
The acquisition of GeneType AG by the Company in 2000 was accounted for under US GAAP as a reverse acquisition for financial reporting purposes. Accordingly, the summary financial data set forth below is that of GeneType (the legal acquiree), with the results of operations of Genetic Technologies (the legal acquiror) included from the effective date of its acquisition (September 30, 2000).
All amounts are in U.S. dollars as of June 30 as noted (except for per share data).
3
GENETIC TECHNOLOGIES LIMITED
CONSOLIDATED PROFIT AND LOSS STATEMENTS
US GAAP FOR 2006, 2005, 2004, 2003 AND 2002
CONVERTED TO U.S. DOLLARS
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Year ended |
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Year ended |
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Year ended |
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Year ended |
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Year ended |
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U.S. Dollars |
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U.S. Dollars |
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U.S. Dollars |
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U.S. Dollars |
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U.S. Dollars |
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REVENUES |
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Licensing Revenue |
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4,997,223 |
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4,970,007 |
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507,910 |
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2,615,544 |
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778,131 |
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Service Testing Revenue |
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1,906,290 |
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1,809,301 |
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1,969,963 |
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1,727,617 |
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838,969 |
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Grant Income |
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426,574 |
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437,278 |
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154,702 |
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50,244 |
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91,610 |
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Other Revenue |
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14,915 |
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3,469 |
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12,427 |
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10,722 |
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17,343 |
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TOTAL REVENUES |
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7,345,002 |
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7,220,055 |
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2,645,002 |
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4,404,127 |
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1,726,053 |
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OPERATING EXPENSES |
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Service Testing Expenses |
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4,547,437 |
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3,510,444 |
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2,244,020 |
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1,820,490 |
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934,732 |
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Research and Development |
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2,815,804 |
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1,830,932 |
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1,669,484 |
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512,345 |
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497,207 |
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Patent and License Fees |
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1,438,345 |
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4,632,617 |
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804,340 |
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428,335 |
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267,408 |
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Sales and Marketing |
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846,808 |
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570,498 |
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993,827 |
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661,211 |
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397,772 |
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General and Administrative |
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2,273,946 |
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2,597,642 |
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2,285,787 |
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1,182,856 |
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1,140,919 |
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TOTAL OPERATING EXPENSES |
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11,922,340 |
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13,142,133 |
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7,997,458 |
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4,605,237 |
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3,238,038 |
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LOSS FROM OPERATIONS |
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(4,577,338 |
) |
(5,922,078 |
) |
(5,352,456 |
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(201,110 |
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(1,511,985 |
) |
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OTHER INCOME (EXPENSE) |
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Interest Income |
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601,803 |
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484,286 |
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352,605 |
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68,387 |
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57,907 |
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Interest Expense |
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(63,316 |
) |
(31,750 |
) |
0 |
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(5,979 |
) |
(5,490 |
) |
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Net Profit (Loss) on Sale of Mining Operations |
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0 |
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0 |
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0 |
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0 |
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43,063 |
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Net Profit (Loss) on Assets |
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1,735 |
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97,809 |
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406,224 |
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(100,191 |
) |
(1,153,309 |
) |
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Net Foreign Exchange Gains (Losses) |
|
92,403 |
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(140,861 |
) |
(171,960 |
) |
(558,292 |
) |
(579,605 |
) |
|
TOTAL OTHER INCOME (EXPENSES) |
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632,625 |
|
409,484 |
|
586,869 |
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(596,075 |
) |
(1,637,434 |
) |
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NET LOSS BEFORE INCOME TAXES |
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(3,944,713 |
) |
(5,512,594 |
) |
(4,765,587 |
) |
(797,185 |
) |
(3,149,419 |
) |
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INCOME TAXES |
|
(67,649 |
) |
(195,339 |
) |
(27,579 |
) |
(167,412 |
) |
(83,000 |
) |
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NET LOSS BEFORE MINORITY INTEREST |
|
(4,012,362 |
) |
(5,707,933 |
) |
(4,793,166 |
) |
(964,597 |
) |
(3,232,419 |
) |
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|
MINORITY INTEREST |
|
(7,961 |
) |
(35,016 |
) |
(23,560 |
) |
4,202 |
|
10,240 |
|
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NET LOSS |
|
(4,020,323 |
) |
(5,742,949 |
) |
(4,816,726 |
) |
(960,395 |
) |
(3,222,179 |
) |
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|
NET LOSS PER
ORDINARY SHARE |
|
(1 |
) |
(2 |
) |
(2 |
) |
(0 |
) |
(1 |
) |
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WEIGHTED-AVERAGE SHARES OUTSTANDING (BASIC AND DILUTED) |
|
362,386,940 |
|
315,264,068 |
|
277,806,689 |
|
261,541,405 |
|
259,757,871 |
|
4
GENETIC TECHNOLOGIES LIMITED
SELECTED CONSOLIDATED BALANCE SHEET DATA
US GAAP FOR 2006, 2005, 2004, 2003 AND 2002
CONVERTED TO U.S. DOLLARS
|
|
|
Year ended |
|
Year ended |
|
Year ended |
|
Year ended |
|
Year ended |
|
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|
U.S. Dollars |
|
U.S. Dollars |
|
U.S. Dollars |
|
U.S. Dollars |
|
U.S. Dollars |
|
|
ASSETS |
|
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Current |
|
9,715,206 |
|
14,372,325 |
|
9,063,848 |
|
4,274,514 |
|
4,631,408 |
|
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Non-Current |
|
6,937,894 |
|
7,941,476 |
|
6,589,525 |
|
1,807,634 |
|
660,338 |
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|
TOTAL ASSETS |
|
16,653,100 |
|
22,313,801 |
|
15,653,373 |
|
6,082,148 |
|
5,291,746 |
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LIABILITIES |
|
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Current |
|
2,186,973 |
|
3,711,241 |
|
3,233,207 |
|
1,349,310 |
|
736,881 |
|
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Non-Current |
|
911,957 |
|
1,252,509 |
|
486,640 |
|
469,490 |
|
392,980 |
|
|
TOTAL LIABILITIES |
|
3,098,930 |
|
4,963,750 |
|
3,719,847 |
|
1,818,800 |
|
1,129,861 |
|
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TOTAL SHAREHOLDERS’ EQUITY |
|
13,424,137 |
|
17,224,715 |
|
11,851,330 |
|
4,204,310 |
|
4,120,945 |
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DIVIDENDS DECLARED PER SHARE |
|
0 |
|
0 |
|
0 |
|
0 |
|
0 |
|
(a) Converted at AUD1.00 = $0.7475, except for assets and liabilities which were converted at AUD1.00 = $0.7423
(b) Converted at AUD1.00 = $0.7564, except for assets and liabilities which were converted at AUD1.00 = $0.7618
(c) Converted at AUD1.00 = $0.7132, except for assets and liabilities which were converted at AUD1.00 = $0.6952
(d) Converted at AUD1.00 = $0.5847, except for assets and liabilities which were converted at AUD1.00 = $0.6713
(e) Converted at AUD1.00 = $0.5236, except for assets and liabilities which were converted at AUD1.00 = $0.5628
EXCHANGE RATES
The following table sets forth, for the periods and dates indicated, certain information concerning the noon buying rate in New York City for Australian dollars expressed in U.S. dollars per AUD1.00 as certified for customs purposes by the Federal Reserve Bank of New York.
|
Period ended |
|
At period end |
|
Average rate (a) |
|
High |
|
Low |
|
|
June 2002 |
|
0.5628 |
|
0.5236 |
|
0.6256 |
|
0.4819 |
|
|
June 2003 |
|
0.6713 |
|
0.5847 |
|
0.6735 |
|
0.5226 |
|
|
June 2004 |
|
0.6952 |
|
0.7132 |
|
0.8005 |
|
0.6345 |
|
|
June 2005 |
|
0.7618 |
|
0.7564 |
|
0.7792 |
|
0.7498 |
|
|
June 2006 |
|
0.7423 |
|
0.7475 |
|
0.7781 |
|
0.7056 |
|
|
July 2006 |
|
0.7664 |
|
0.7528 |
|
0.7664 |
|
0.7407 |
|
|
August 2006 |
|
0.7630 |
|
0.7631 |
|
0.7699 |
|
0.7568 |
|
|
September 2006 |
|
0.7461 |
|
0.7549 |
|
0.7704 |
|
0.7461 |
|
|
October 2006 |
|
0.7743 |
|
0.7544 |
|
0.7743 |
|
0.7434 |
|
|
November 2006 |
|
0.7896 |
|
0.7728 |
|
0.7896 |
|
0.7629 |
|
(a) The average of the exchange rates on the last day of each month during the financial period.
5
Item 3.B Capitalization and Indebtedness
Not applicable.
Item 3.C Reasons for the Offer and Use of Proceeds
Not applicable.
Before you purchase our ADSs, you should be aware that there are risks, including those described below. You should consider carefully these risk factors together with all of the other information contained elsewhere in this Annual Report before you decide to purchase our ADSs.
Risks Related to Us
Our stock price is volatile and can fluctuate significantly based on events not in our control and general industry conditions. As a result, the value of your investment may decline significantly.
The biotechnology sector can be particularly vulnerable to abrupt changes in investor sentiment. Stock prices of companies in the biotechnology industry, including ours, can swing dramatically, with little relationship to operating performance. Our stock price may be affected by a number of factors including, but not limited to:
· product development events;
· the outcome of litigation;
· decisions relating to intellectual property rights;
· the entrance of competitive products/technologies into our market;
· new medical discoveries;
· the establishment of strategic partnerships and alliances;
· changes in reimbursement policies or other practices related to the pharmaceutical industry; or
· other industry and market changes or trends.
Since June 30, 2002, the price of our Ordinary Shares has ranged from a low of AUD0.18 to a high of AUD0.87 per share. Further fluctuations are likely to occur due to events not within our control and general market conditions affecting the biotechnology sector or the stock market generally. The most significant such event of which we have knowledge took place in August 2003 after a television report in Australia on our company was broadcast. During that week, the price of our shares increased from AUD0.58 to AUD0.87 on a volume of 26,000,000 shares traded, which was exceptionally high for us. The share price subsequently retreated.
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 the trading volume of our ADSs on the NASDAQ Global Market has typically also been low. Further, because each of our ADSs represents 30 of our Ordinary Shares, trading volume in our ADSs is 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 would be the case if the trading volume were higher.
6
The following chart graphically illustrates the fluctuation in the price of our shares (in Australian dollars) over the last five years:
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 in the foreseeable future. We intend to retain future cash earnings, if any, for reinvestment in the development and expansion of our business. Whether we pay cash dividends in the future will be at the discretion of our Board of directors and may be dependent on our financial condition, results of operations, capital requirements and any other factors our Board of directors decides is relevant. As a result, an investor may only recognize an economic gain on an investment in our stock from an appreciation in the price of our stock.
You may have difficulty in effecting service of legal process and enforcing judgments against us and our Management.
We are a public company limited by shares, registered and operating under the Australian Corporations Act 2001. All of our directors and officers named in this Annual Report reside outside the U.S. Substantially all, or a substantial portion of, the assets of those persons are also located outside the U.S. As a result, it may not be possible to affect 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, substantially all of our directly-owned assets are located outside the U.S., and, as such, any judgment obtained in the U.S. against us may not be collectible within the U.S. There is doubt as to the enforceability in the Commonwealth 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.
Because we are not necessarily required to provide you with the same information as an issuer of securities based in the United States, you may not be afforded the same protection or information you would have if you had invested in a public corporation based in the United States.
We are exempt from certain provisions of the Securities Exchange Act of 1934, as amended, commonly referred to as the Exchange Act, 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 security registered under the Exchange Act; 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. The exempt provisions would be available to you if you had invested in a U.S. corporation.
7
However, in line with the Australian Securities Exchange regulations, we will disclose our semi-annual results, which, in accordance with Australian auditing standards, are required to have a limited review semi-annually and be fully audited annually. The information, which may have an effect on the stock price on the Australian Securities Exchange, will also be disclosed immediately in the public media and to the Australian Securities Exchange. Other relevant information pertaining to our Company will also be disclosed in line with the Australian Securities Exchange regulations and information dissemination requirements for listed companies. We will provide our semi-annual results and other material information that we make public in Australia in the U.S. under the cover of an SEC Form 6-K. Nevertheless, you may not be afforded the same protection or information, which would be made available to you, were you investing in a United States public corporation because the requirements of a Form 10-Q and Form 8-K are not applicable to us.
If a public market does not develop for our ADSs, your ability to resell your ADSs could be negatively affected because there would be limited buyers for your interests.
Historically, there was virtually no trading in our ADSs through the pink sheets after the establishment of our Level I ADR Program. However, subsequent to the Level II listing of our ADSs on the NASDAQ Global Market on September 2, 2005, the trading volumes of our ADSs have increased. An active trading market for the ADSs, however, may not be maintained in the future. If an active trading market is not maintained, the liquidity and trading prices of the ADSs could be negatively affected.
In certain circumstances, holders of ADRs may have limited rights relative to holders of Ordinary Shares.
The rights of holders of ADSs with respect to the 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 The Bank of New York. 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 try, as far as practical, to vote the Ordinary Shares so represented in accordance with such instructions, ADS holders may not receive notices sent by the depositary in time to ensure that the depositary will vote the Ordinary Shares. This means that the holders of ADRs 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. For further information about the rights and limitations on rights applicable to holders of our ADSs, please see Item 12D of this Annual Report entitled “American Depositary Shares”.
Our Company has a history of losses and we expect to continue to incur costs.
Genetic Technologies Limited was founded in 1989. We have incurred operating losses in every year of our existence. We incurred net losses of $3,222,179 for the year ended June 30, 2002, net losses of $960,395 for the year ended June 30, 2003, net losses of $4,816,726 for the year ended June 30, 2004, net losses of $5,742,949 for year ended June 30, 2005 and net losses of $4,020,323 for year ended June 30, 2006. As of June 30, 2006, we have accumulated losses of $17,002,436. The extent of future losses and the time required to achieve profitability remains uncertain.
Risks Related to our Industry
Our sales cycle is typically lengthy.
The sales cycle for our testing products and license generation is typically lengthy. As a result, we may expend substantial funds and management effort with no assurance of successfully selling our products or services or granting new licenses. Our ability to obtain customers for our genetic testing services depends significantly on the perception that our services can help accelerate efforts in genomics. The sales cycle is typically lengthy. Our sales effort requires the effective demonstration of the benefits of our services to, and significant training of, many different departments within a potential customer. In addition, we sometimes are required to negotiate agreements containing terms unique to each customer. With respect to license generation, it is common for negotiations with licensees to take many months before a license is eventually granted. Our business could also be adversely affected if we expend money without any return.
8
If our competitors develop more effective products, the results from our operations and financial condition could be affected.
We are subject to limited competition from biotechnology and diagnostic companies, academic and research institutions and government or other publicly-funded agencies that are pursuing products and services that are substantially similar to our genetic testing services, or which otherwise address the needs of our customers and potential customers. Our competitors in the testing market include private and public sector enterprises located in Australia and elsewhere. Many of the organizations competing with us have greater experience in the areas of finance, research and development, manufacturing, marketing, sales, distribution, technical and regulatory matters than we do. In addition, many current and potential competitors have greater name recognition and more extensive collaborative relationships. However, because of our patents, we have virtually no competition in the licensing area.
Our competitive position in the testing area is based upon our ability to:
· create and maintain scientifically-advanced technology and offer proprietary products and services;
· attract and retain qualified personnel;
· obtain patent or other protection for our products and services;
· obtain required government approvals and other accreditations on a timely basis; and
· successfully market our services.
If we are not successful in meeting these goals, our business could be adversely affected. Similarly, our competitors may succeed in developing technologies, products or services that are more effective than any that we are developing or that would render our technology and services obsolete, noncompetitive or uneconomical.
For a full discussion of competition see Item 4.B, “Competition”.
We rely heavily upon our patents and proprietary technology and any future claims that our patents are invalid could seriously affect our licensing business and adversely affect our revenues and our financial condition.
We rely upon our portfolio of patent rights, patent applications and exclusive licenses to patents and patent applications relating to genetic technologies. We expect to aggressively patent and protect our proprietary technologies. However, we cannot be certain that any additional patents will be issued to us as a result of our domestic or foreign patent applications or that any of our patents will withstand challenges by others. Patents issued to, or licensed by, us may be infringed or third parties may independently develop either the same or similar technologies. Similarly, our patents may not provide us with meaningful protection from competitors, including those who may pursue patents which may prevent, limit or interfere with our products or will require licensing and the payment of significant fees or royalties by us to such third parties in order to enable us to conduct our business. We may sue or be sued by third parties regarding our patents and other intellectual property rights. These suits are often costly and would divert valuable funds and technical resources from our operations and cause distraction to Management.
We have important relationships with external parties over whom we have limited control.
We have relationships with a number of academic consultants who are not employed by us. Accordingly, we have limited control over their activities and can expect only limited amounts of their time to be dedicated to our activities. These persons may have consulting, employment or advisory arrangements with other entities that may conflict with or compete with their obligations to us. Our consultants typically sign agreements that provide for confidentiality of our proprietary information and results of studies. However, in connection with every relationship, we may not be able to maintain the confidentiality of our technology, the dissemination of which could hurt our competitive position and results of operations. To the extent that our scientific consultants develop inventions or processes independently that may be applicable to our proposed products, disputes may arise as to the ownership of the proprietary rights to such information, and we may not win those disputes.
9
If we are unable to protect our proprietary methods and technologies, we may not be able to commercialize products or services.
Our commercial success will largely depend on our ability to obtain patent protection for many aspects of our business, including the products, methods and services we develop. Patents issued to us may not provide us with substantial protection or be commercially beneficial to us. The issuance of a patent is not conclusive as to its validity or its enforceability. In addition, our patent applications or those we have licensed, may not result in issued patents. If our patent applications do not result in issued patents, our competitors may obtain rights to commercialize our discoveries which could harm our competitive position. We also may apply for patent protection on novel genetic variations in known genes and their uses, as well as novel uses for previously identified genetic variations discovered by third parties. In the latter cases, we may need a license from the holder of the patent with respect to such genetic variations in order to make, use or sell any related products. We may not be able to acquire such licenses on terms acceptable to us, if at all.
Certain parties are attempting to rapidly identify and characterize genes and genetic variations through the use of sequencing and other technologies. To the extent that any patents are issued to other parties on such partial or full-length genes or genetic variations or uses for such genes or genetic variations, the risk increases that the sale of products or services developed by us or our collaborators may give rise to claims of patent infringement against us. Others may have filed and, in the future, are likely to file patent applications covering many genetic variations and their uses. Any such patent applications may have priority over our patent applications and could further require us to obtain rights to previously issued patents covering genetic variations. Any license that we may require under any such patent may not be made available to us on commercially acceptable terms, if at all.
We may be sued for infringing on the intellectual property rights of others. We could also become involved in interference proceedings in the United States Patent and Trademark Office to determine the relative priority of our patents or patent applications and those of the other parties involved in the interference proceeding. Intellectual property proceedings are costly, and could affect our results of operations. These proceedings can also divert the attention of managerial and technical personnel. If we do not prevail in any intellectual property proceeding, in addition to any damages we might have to pay, we could be required to stop the infringing activity, or obtain a license to or design around the intellectual property in question. In interference proceedings, our patent rights could be invalidated and the scope of our patents could be limited. If we are unable to obtain licenses to intellectual property rights that we need to conduct our business, or are unable to design around any third party patent, we may be unable to sell some of our products, which will result in reduced revenue.
We have in the past and may possibly in the future become a party to litigation involving patents and intellectual property rights. We have previously commenced litigation against a number of parties to protect our rights pertaining to our intellectual property. We may in the future receive claims of infringement of intellectual property rights from other parties. If we do not prevail in any future legal proceedings, we may be required to pay significant monetary damages. In addition, we could also be enjoined from use of certain processes or prevented from selling certain configurations of our products or services that were found to be within the scope of the patent claims. In the event we did not prevail in any future proceeding, we would either have to obtain licenses from the other party, avoid certain product configurations or modify some of our products, services and processes to design around the patents. Licenses could be costly or unavailable on commercially reasonable terms. Designing around patents or focusing efforts on different configurations could be time consuming, and we may have to remove some of our products or services from the market while we were completing redesigns. Accordingly, if we are unable to settle future intellectual property disputes through licensing or similar arrangements, or if any such future disputes are determined adversely to us, our ability to market and sell our products and services could be seriously harmed. This would in turn reduce demands for our services and harm our financial condition and results of operations.
In addition, in order to protect or enforce our patent rights or to protect our ability to operate our business, we may need to initiate other patent litigation against third parties. These lawsuits could be expensive, take significant time, and could divert Management’s attention from other business concerns. These lawsuits could result in the invalidation or limitation in the scope of our patents or forfeiture of the rights associated with our patents. We may not prevail in any such proceedings and a court may find damages or award other remedies in favor of our opposing party in any of these suits. During the course of any future proceedings, there may be public announcements of the results of hearings, motions and other interim proceedings or developments in the litigation. Securities analysts or investors may perceive these announcements to be negative, which could cause the market price of our stock to decline.
10
We may be subject to professional liability suits and our insurance may not be sufficient to cover damages. If this occurs, our business and financial condition may be adversely affected.
Our business exposes us to potential liability risks that are inherent in the testing, manufacturing, marketing and sale of genetic tests. The use of our products and product candidates, whether for clinical trials or commercial sale, may expose us to professional liability claims and possible adverse publicity. We may be subject to claims resulting from incorrect results of analysis of genetic variations or other screening tests performed using our services. Litigation of such claims could be costly. We could expend significant funds during any litigation proceeding brought against us. Further, if a court were to require us to pay damages to a plaintiff, the amount of such damages could significantly harm our financial condition. Although we have public and products liability insurance coverage under broadform liability and professional indemnity policies, for an aggregate amount of AUD60,000,000, the level or breadth of our coverage may not be adequate to fully cover potential liability claims. To date we have not been subject to any claims, or ultimately liability, in excess of the amount of our coverage. In addition, we may not be able to obtain additional professional liability coverage in the future at an acceptable cost. A successful claim or series of claims brought against us in excess of our insurance coverage and the effect of professional liability litigation upon the reputation and marketability of our technology and products, together with the diversion of the attention of key personnel, could negatively affect our business.
We use potentially hazardous materials, chemicals and patient samples in our business and any disputes relating to improper handling, storage or disposal of these materials could be time consuming and costly.
Our research and development, production and service activities involve the controlled use of hazardous laboratory materials and chemicals, including small quantities of acid and alcohol, and patient tissue and blood samples. We do not knowingly deal with infectious samples. We, our collaborators and service providers are subject to stringent Australian federal, state and local laws and regulations governing occupational health and safety standards, including those governing the use, storage, handling and disposal of these materials and certain waste products. However, we could be liable for accidental contamination or discharge or any resultant injury from hazardous materials, and conveyance, processing, and storage of and data on patient samples. If we, our collaborators or service providers fail to comply with applicable laws or regulations, we could be required to pay penalties or be held liable for any damages that result and this liability could exceed our financial resources. Further, future changes to environmental health and safety laws could cause us to incur additional expense or restrict our operations. We have never had a reportable injury through the date of this Annual Report.
In addition, our collaborators and service providers may be working with these types of hazardous materials, including hazardous chemicals, in connection with our collaborations. In the event of a lawsuit or investigation, we could be held responsible for any injury caused to persons or property by exposure to, or release of, these patient samples that may contain viruses and hazardous materials. The cost of this liability could exceed our resources. While we maintain broadform liability insurance coverage for these risks, in the amount of up to AUD40,000,000, the level or breadth of our coverage may not be adequate to fully cover potential liability claims. To date, we have not been subject to claims, or ultimately liability, in excess of the amount of our coverage. Our broadform insurance coverage also covers us against losses arising from an interruption of our business activities as a result of the mishandling of such materials. We also maintain workers’ compensation insurance, which is mandatory in Australia, covering all of our workers in the event of injury.
We depend on the collaborative efforts of our academic and corporate partners for research, development and commercialization of some of our products. A breach by our partners of their obligations, or the termination of the relationship, could deprive us of valuable resources and require additional investment of time and money.
Our strategy for research, development and commercialization of some of our products involves entering into various arrangements with academic and corporate partners and others. As a result, our strategy depends, in part, upon the success of these outside parties in performing their responsibilities. Our collaborators may also be our competitors. We cannot control the amount and timing of resources that our collaborators devote to performing their contractual obligations and we have no certainty that these parties will perform their obligations as expected or that any revenue will be derived from these arrangements.
11
If our collaborators breach or terminate their agreement with us or otherwise fail to conduct their collaborative activities in a timely manner, the development or commercialization of the product candidate or research program under such collaborative arrangement may be delayed. If that is the case, we may be required to undertake unforeseen additional responsibilities or to devote unforeseen additional funds or other resources to such development or commercialization, or such development or commercialization could be terminated. The termination or cancellation of collaborative arrangements could adversely affect our financial condition, intellectual property position and general operations. In addition, disagreements between collaborators and us could lead to delays in the collaborative research, development, or commercialization of certain products or could require or result in formal legal process or arbitration for resolution. These consequences could be time-consuming and expensive and could have material adverse effects on us.
Other than our contractual rights under our license agreements, we may be limited in our ability to convince our licensees to fulfill their obligations. If our licensees fail to act promptly and effectively, or if a dispute arises, it could have a material adverse effect on our results of operations and the price of our Ordinary Shares and ADSs.
We rely upon scientific, technical and clinical data supplied by academic and corporate collaborators, licensors, licensees, independent contractors and others in the evaluation and development of potential therapeutic methods. There may be errors or omissions in this data that would materially adversely affect the development of these methods.
We may seek additional collaborative arrangements to develop and commercialize our products in the future. We may not be able to negotiate acceptable collaborative arrangements in the future and, if negotiated, we have no certainty that they will be on favorable terms or will be successful. In addition, our collaborative partners may pursue alternative technologies independently or in collaboration with others as a means of developing treatments for the diseases targeted by their collaborative programs with us. If any of these events occurs, the progress of the Company could be adversely affected and our results of operations and financial condition could suffer.
Problems associated with international business operations could affect our ability to license our technology and our results of operations.
We seek to license our intellectual property on a global scale, including eventually in countries that are considered to provide significantly less protection to intellectual property than the United States and Australia. In addition, a number of other risks are inherent in international transactions and commerce, including political and economic instability, foreign currency exchange fluctuations and changes in tax laws. For example, in fiscal year 2003, we sustained foreign exchange losses of over $500,000 primarily due to the appreciation in the value of the Australian Dollar compared to the U.S. Dollar and the impact on our cash deposits which are denominated in U.S. Dollars.
Government regulation of geneticresearch or testing may adversely affect the demand for our services and impair our business and operations.
Apart from accreditation requirements, we are generally not subject to regulation. Federal, state and local governments, however, may adopt regulations relating to the conduct of genetic research and genetic testing. These regulations could limit or restrict genetic research activities as well as genetic testing for research or clinical purposes. In addition, if state and local regulations are adopted, these regulations may be inconsistent with, or in conflict with, regulations adopted by other state or local governments. Regulations relating to genetic research activities could adversely affect our ability to conduct our research and development activities. Regulations restricting genetic testing could adversely affect our ability to market and sell our services. Accordingly, any regulations of this nature could increase the costs of our operations or restrict our ability to conduct our testing business and might adversely affect our operations and financial condition.
In Australia, there is no law that prohibits the performing a paternity test by using just a sample obtained from a father and child. In May 2003, the Australian Law Reform Commission (ALRC) released its report into Human Genetic Testing in Australia. In relation to paternity testing, it made various recommendations, the most significant of which was that the testing of a child without the knowledge or consent of both parents should be made illegal. In December 2005, the Australian Government formally responded to the ALRC report. Although it accepted most of the report’s recommendations, it did not accept its recommendation that it should be illegal to test a child without the knowledge or consent of both parents. Instead, it recommended that the body that formally accredits laboratories, National Association of Testing Authorities (NATA) should review its accreditation requirements for DNA parentage testing to ensure that laboratories meet the highest technical and ethical standards, particularly in relation to consent to testing, protecting the integrity of genetic samples, and providing information about counselling.
12
This approach is very similar to the model adopted in the United Kingdom where, for a laboratory to perform tests for legal purposes, it is not allowed to perform testing where just the father and the child give a sample without the knowledge or consent of the mother. If NATA follows the UK model, this will have a negative impact on our revenue as father/child testing is a substantial and growing market.
The Government also rejected the ALRC recommendation that all human DNA testing laboratories be accredited by NATA. This means that the non-accredited providers can continue to offer this type of testing. It should be noted, however, that none of the Government’s recommendations in relation to the report have yet been incorporated into legislation and it is not known when this will occur.
We rely on the services of individuals who possess special skills and experience.
Much of the future success of the Company depends on the continued service and availability of skilled personnel, including its Chief Executive Officer, members of its senior executive team, and those in technical, marketing and staff positions. While we are actively recruiting new employees with such skills and experience to reduce our reliance on these individuals, however skilled personnel, with specific experience in the biotechnology industry, are in high demand and competition for their talents is intense.
Ethical and other concerns surrounding the use of genetic information may reduce the demand for our services.
Public opinion regarding ethical issues related to the confidentiality and appropriate use of genetic testing results may influence governmental authorities to call for limits on, or regulation of the use of, genetic testing. In addition, such authorities could prohibit testing for genetic predisposition to certain conditions, particularly for those that have no known cure. Furthermore, adverse publicity or public opinion relating to genetic research and testing, even in the absence of any governmental regulation, could reduce the potential markets for our services, which could materially and adversely affect our revenues.
Although we are a leader in the field of genetics in Australia, we do not undertake any activities in the contentious areas of cloning, stem cell research or other gene-altering areas. As such, many of the ethical issues that may be relevant to other participants in the genetics industry are not applicable to us.
Licensing
The patenting of genes and issues surrounding access to genetic knowledge are the subjects of extensive and ongoing public debate in many countries. In recent times, for example, the Australian Law Reform Commission has conducted two inquiries into the social uses of genetic information. The patents we hold over uses of “non-coding” DNA have a broad scope and these have also been the subject of debate and some criticism in the media. A risk we may face is that individuals or organisations in any of the countries in which these patents have issued could potentially take legal action to seek their amendment, revocation or invalidation.
Furthermore, any time that we initiate legal action against parties that infringe our patents we face a risk that the infringer will defend itself through a counter-claim of patent invalidity. Subsequent legal action could potentially overturn, invalidate or limit the scope of our patents.
Under the relevant Patent Act in most, if not all, of the countries in which our non-coding patents have issued, the relevant judicial system has rights to impose compulsory licensing. The relevant governments typically hold “march-in” rights by which they may unilaterally choose to exploit the technology. To the extent that the Company’s non-coding technology is used in the conduct of genetic research, we also face risks, uncertainty and controversy over the licensing of our technology to those conducting research. Whether or not researchers should be exempted from obligations to take licenses to the relevant patents was the subject of another government inquiry being conducted by the Australian Council for Intellectual Property who recommended the creation of a research exemption.
13
Genetic testing
There is a risk that a moratorium on genetic testing by the Australian Institute of Sport may impact on the commercialization of our sports performance genetic test for the elite competitor market in Australia. However, this moratorium should not impact our ability to distribute this test throughout the rest of the world. There is also a view held by some elements of the medical and academic communities that the marketing of some of our cancer predisposition tests is done solely with a commercial objective in mind. In essence, some parties have indicated that, in their view, the risk of inheriting certain types of cancer is too low to warrant the marketing of genetic testing services to the wider cancer community where such promotion may increase anxiety unnecessarily. Guidelines laid down by the Australian National Health Medical Research Council also prevent us from promoting our testing in a manner which may “cause any unnecessary alarm”.
In recent years, health care payors as well as federal and state governments have focused on containing or reducing health care costs. We cannot predict the effect that any of these initiatives may have on our business. In particular, gene-based therapeutics, if successfully developed and commercialized, are likely to be costly compared to currently available drug therapies. Health care cost containment initiatives focused either on gene-based therapeutics or on genetic testing could result in the growth in the clinical market for genetic testing being curtailed or slowed. In addition, health care cost containment initiatives could also cause pharmaceutical companies to reduce research and development spending. In either case, our business and our operating results could be adversely affected. Further, genetic testing in clinical settings is often billed to third-party payors, including private insurers and governmental organizations. If our current and future clinical products and services are not considered cost-effective by these payors, reimbursement may not be available to users of our services. In this event, potential customers would be much less likely to use our services and our business and operating results could be seriously harmed.
ITEM 4. INFORMATION ON THE COMPANY
Item 4.A History and Development of the Company
We were incorporated under the laws of Western Australia on January 5, 1987 as Concord Mining N.L. On August 13, 1991 we changed our name to Consolidated Victorian Gold Mines N.L. On December 2, 1991, we changed our name to Consolidated Victorian Mines N.L. On March 15, 1995, we changed our name to Duketon Goldfields N.L.
On October 15, 1999, the type of company was changed from a No Liability Company to a company limited by shares. On August 29, 2000, we changed our name to Genetic Technologies Limited, which is our current name. We were originally incorporated as a mining company and gradually phased out our mining activities and became a biotechnology company with the acquisition of GeneType AG in August 2000. Our Australian Company Number (ACN) is 009 212 328. Our Australian Business Number (ABN) is 17 009 212 328. We operate pursuant to our constitution, the Australian Corporations Act, the Australian Securities Exchange Listing Rules, the Marketplace Rules of NASDAQ and, where applicable, local legislation.
Our registered office, headquarters, laboratory and business activities are all located at 60-66 Hanover Street, Fitzroy, Victoria, 3065 Australia. Our telephone number is +61 3 9415 1135. Our website address is www.gtg.com.au. Information on our website and websites linked to it does not constitute part of this Annual Report.
On August 29, 2000, we acquired 100% of GeneType AG, including all of its valuable patents, and we changed our focus exclusively to the area of biotechnology. We also changed our name to Genetic Technologies Limited to better reflect our new business. In September 2000, our listing was duly transferred from the mining board of the ASX to the industrial board and our shares were thereafter classified under the industry group “Health and Biotechnology”, completing our transformation from a mining and resources company into a biotechnology company. During 2001, we also acquired 10% of the issued and outstanding shares in Cytomation Inc., based in Fort Collins, Colorado. At that time, Cytomation was a leader in the manufacture and sales of flow cytometers and cell sorters. Also, in December 2001, we acquired an initial shareholding of less than 1% in the issued capital of XY, Inc., a company also based in Fort Collins. In July 2001, we acquired the business of DNA-ID Labs in Perth, Western Australia, as part of our strategy of expanding our paternity testing business in Australia. In March 2002, we formed AgGenomics Pty. Ltd., based in Melbourne, in order to expand our genetic testing services into the field of plant genetics. In May 2003, we acquired the fixed assets of the business Genetic Science Services in Melbourne, in order to further expand into the field of genetic testing.
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Since the acquisition of GeneType AG, with the exception of certain minor passive interests, the directors have disposed of all remaining mining interests so that our activities now focus solely on emerging opportunities in the field of biotechnology. Our current activities in biotechnology primarily concentrate on three clearly defined areas of activity which are covered under Item 4.B “Business Overview”.
In early calendar year 2002, we commenced the process of out-licensing our non-coding patents, announcing several early successes. The first license to our non-coding patents was granted to Genetic Solutions Pty. Ltd. of Australia, and soon after, to Nanogen Inc., Sequenom Inc., Perlegen Sciences Inc. and Myriad Genetics Inc. all of USA. In the first half of 2003, we granted licenses to Pyrosequencing AB (now Biotage AB) of Sweden, to ARUP and the University of Utah. During the year ended June 30, 2004, we granted licenses to the University of Sydney, in Australia, Quest Diagnostics Inc. of USA, King’s College London, ViaLactia Biosciences (NZ) Limited of New Zealand, University of Technology, Sydney, Australia, TM Bioscience Corporation of Canada, Laboratory Corporation of America Holdings, Colorado State University of USA, C.Y. O’Connor ERADE Village Foundation of Perth, Western Australia and Ovita Limited of New Zealand. Since June 30, 2004, we have granted licenses to Genzyme Corporation of USA, MetaMorphix Inc. of USA, Bionomics Limited of Adelaide, South Australia, the Australian Genome Research Facility of Brisbane, Queensland, four parties in New Zealand, Applera Corporation, Bovigen LLC and Optigen LLC all of USA, Innogenetics NV of Belgium and GENOSENSE of Austria. These licenses are more fully described below under Item 4.B “Business Overview”.
It is a priority for the Company to continue to identify additional parties who would benefit from taking a license to the Company’s non-coding patents. We are now pursuing negotiations with companies and organizations in USA, Europe, Australia, New Zealand, Canada, Japan and South America that would all benefit from taking a license to our non-coding patents or from collaborations with our service testing business.
In order to increase the rate at which these licenses can be secured, the licensing team at the Company’s headquarters in Melbourne, Australia was expanded during the year by the appointment of additional staff to accelerate the preparation of dossiers on potential licensees. Internationally, four independent licensing contractors were also engaged to represent the Company “on the ground”, two each in our major markets of USA and Europe.
Item 4.B Business Overview
We are a biotechnology company, now pursuing commercial opportunities in three main areas of activity:
(i) out-licensing our non-coding patents globally;
(ii) expanding our genetic service-testing business in the Asia-Pacific Region; and
(iii) supporting certain research projects in which we are already involved.
Industry Background
The Human Genome Project (HGP) announced (in 2003) the completion of the first draft of the entire sequence of the human genome. The biotechnology industry is now working to build upon the vast amount of knowledge generated by that program in order to develop a better understanding of the genetic basis of human health and disease. Increasingly, genetics is being shown to play a key role in the diagnosis and treatment of many diseases in humans, as well as diseases in animals and plants. Our growing understanding of genetics is now providing new information for understanding such predisposing or causative factors in many of these diseases.
More recently, the successful mapping of the Mouse Genome was published in December, 2002, and this permitted for the first time, a detailed comparison of human genes and mouse genes. One of the key findings that has arisen from this work is the significant role that non-coding DNA plays in controlling gene function in both human genes and mouse genes. For some scientists, but not for our company, these findings - of the great significance of non-coding DNA to gene function - were new, significant and totally unexpected.
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A major focus in science is now the identification and analysis of genetic variations and disease-associated genes within the genome. These genetic variations, or polymorphisms, in the DNA sequences vary between individuals. The most common genetic variations are Single Nucleotide Polymorphisms, or SNPs, which are merely a difference in a single nucleotide. The first draft of the human genome identified over 1.4 million SNPs that can be useful as positional signposts for disease-associated DNA sequences in a gene or as markers to map genes along a chromosome. A significant number of these SNPs (perhaps more than 97%) are now known to be non-coding.
Genomics
A genome is an organism’s complete set of DNA and the study of that DNA is called genomics. Genomes vary in size, with bacteria displaying the smallest known genome at 600,000 DNA base pairs, while human and mouse genomes have over 3 billion. The DNA of the human genome is organized into 24 distinct chromosomes that contain from 50 million to 250 million base pairs on each chromosome. The DNA on each chromosome contains genes that are specific sequences that encode proteins that actually perform the work within a cell and also make up the cell itself. Surprisingly, only about 2% to 5% of the human genome is organized into coding DNA, with the remainder being considered to be non-coding DNA. Our patent portfolio is centered on proprietary methods for utilizing the valuable information contained within these non-coding regions.
Genetic Variability
Almost 99.9% of an individual’s genome is identical to that of every other individual’s genome. However, even slight variations in sequence can drastically change how a gene functions. Variations can lead to harmless changes, such as blue eyes instead of brown, or to major diseases such as cancer, cystic fibrosis, or cardiovascular disease. Genetic variations can also be responsible for many of the differences in the ways individuals respond to drug therapies. As a result of this knowledge, routine analysis of SNPs and other genetic variations is expected to play an increasingly important role in the discovery and development of new drugs, as well as in a variety of diagnostic therapeutic and other medical and life science applications. Industry sources estimate there are millions of genetic variations in the human genome, creating demand for products and technologies that can quickly and accurately detect and analyze these variations. It is thought that the medicine of the future will be dispensed to a patient based on his or her own specific DNA variations. This type of “personalized medicine” will require sophisticated genetic tests to determine the genetic composition of an individual, and it is now recognized that such genetic make-up depends not only on the form of the coding DNA, but also the form of the associated non-coding DNA.
Genetic Tests
Most genes come in many different forms, called alleles. One or more allele may be associated with a particular disease state. Genetic testing involves the direct examination of an individual’s DNA for a DNA marker associated with the allele of interest. The determination of the particular alleles an individual has within his or her DNA is called genotyping.
The most commonly tested marker of a particular allele is a SNP. As much as 98% of the human genome is considered to be non-coding DNA, the majority of the identified 1.4 million SNPs are also located in non-coding regions of DNA. We believe that a license to our proprietary methods of analyzing non-coding regions of DNA will be absolutely necessary for many of the genetic tests of the future. Similarly, tests for genetic abnormalities or mutations may involve not just individual SNPs, but also groups of SNPs or even larger sequences of DNA, and such abnormal sequences – large or small – may be located either in the coding region alone, or in the non-coding region alone, or in both the coding and non-coding regions of the gene (or genes) under examination. Clearly, the variations within genes that may be responsible for a disease are now known to be much more complicated than was previously understood, and the role of non-coding DNA is now being found to be highly relevant in a growing number of diseases. This similarly applies to genetic disorders in animals and in plants. Accordingly, more and more genetic testing will in future look not only at coding variations, but also at the non-coding variations within a particular gene.
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Our Patent Portfolio
The acquisition of GeneType AG gave our company ownership rights to a potentially significant portfolio of issued patents. The major families of patents in the portfolio include:
(a) Intron sequence analysis;
(b) Genomic mapping;
(c) Fetal cell recovery;
(d) Electrophoresis standards;
(e) Sports performance;
(f) Parasitology;
(g) Ancestral haplotypes for tissue typing;
(h) Markers for disease; and
(i) Modulation of the immune system.
(a) The Intron Sequence Analysis patents - allow for the detection of specific motifs within the genetic material in the non-coding regions of DNA which have been shown may be linked to certain alleles or haplotypes within the coding region of the gene. In other words, whereas most geneticists previously looked at the genetic information located within the coding region alone, our inventions have provided a means of also looking at additional useful information which is located within the non-coding part of the gene, and which is now known to also be important in influencing gene function and, in particular, protein production. The method is useful, for example, in the determination of tissue typing for transplantation in order to test for possible likely acceptance or rejection of bone marrow or tissue grafts. The method is also useful in the detection of genetic changes or mutations in the non-coding region of certain genes associated with a higher incidence of certain genetic diseases, such as cystic fibrosis, susceptibility to breast cancer, multiple sclerosis, Alzheimer’s Disease, etc. It is also now known that more than 100 human diseases are associated with genetic changes in the non-coding part of a particular gene and which are linked to the function of the coding part of that gene. Similar applications also exist in animals and plants. Several important markers in livestock, for example, have been shown to be located in the non-coding part of the DNA and also linked to particular coding function – for example, marbling or tenderness. It has also been shown that variations in the non-coding DNA of plants can influence their function, including the color of flowers and the timing of germination and growth.
(b) The Genomic Mapping patents - describe methods for analyzing genetic material collected from various selected populations to identify and locate genes and markers of interest, by identifying highly polymorphic sites throughout the genome and particular haplotypes associated with such sites, all based on a reading of sequence information in both the coding and the non-coding portions of the genome.
(c) The Fetal Cell Recovery patents - describe a novel and safe method for the isolation and collection of fetal cells from the peripheral blood of a pregnant woman, utilizing various HLA or other markers plus flow cytometry - all without any invasive procedure that might endanger the mother or the child. These patents form the basis of the RareCellect project.
(d) The Electrophoresis Standards patents - describe a method for identifying band positions in an electrophoretic separation by also including a control, which serves as an internal standard.
(e) The Sports Performance patents - describe a method that enables aspects of athletic performance to be predicted based on detection of various forms of the alpha actinin 3 (ACTN3) gene.
(f) The Parasitology patents - describe means to identify and to control a variety of species of parasites. The initial patents describe the use of genetic technologies to identify potentially human pathogenic species of the water-borne parasite species of Cryptosporidium and distinguish them from non-pathogenic strains. This enables more accurate typing of Cryptosporidium organisms which may be important in the management of disease outbreaks. The second series of patent applications describe the use of modern genetic technologies to identify two novel classes of chemicals which can be used to control the major parasitic worms of sheep and cattle. These nematodes are responsible for extensive economic losses to the sheep and cattle industries and are rapidly developing resistant to the existing chemicals. The novel classes of chemical described in these patents offer a safe and highly effective alternative.
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(g) The Ancestral Haplotypes for Tissue Typing patents – describe a method for determining ancestral haplotypes using haplospecific geometric elements within the major histocompatibility complex multi gene cluster and methods of genetic analysis involving the amplification of complimentary duplicons. These patents were acquired from the C.Y. O’Connor ERADE Village Foundation.
(h) The Markers for Disease patents - describe a group of patents relating to uses of a group of genetic variations called “variable number tandem repeats” (VNTRs). Particular uses have been found for VNTR’s in predicting predisposition to addiction.
(i) The Modulation of the Immune System patents - describe various methods aimed at improving the efficacy of cancer therapy and treatment of HIV-AIDS and form the basis of the ImmunAid project.
In total, we own 8 issued patents and 9 pending patents in the United States. Reflecting our international business strategy, we have also sought and been granted foreign patents by many other major industrialized nations, corresponding to each of the major patents already issued in the United States.
The many issued, allowed and pending patents claimed by GeneType AG, and which are now owned by our Company, distinguish us from competitors by giving us the legal right to claim ownership or proprietary methods and compositions for analysis of DNA using information contained within non-coding regions and for isolation of fetal cells from a maternal blood sample. The methods and compositions for analysis of DNA may be used to identify a particular form of a gene or to map the location of a disease-associated gene along a chromosome.
Generally, United States patents have a term of 17 years from the date of issuance for patents filed with the United States Patent Office prior to June 8, 1995, and 20 years from the application filing date or earlier claimed priority date in the case of patents issued from applications filed on or after June 8, 1995. For applications filed after May 29, 2000, the term is 20 years from the date of filing. A minimum term of 17 years is assured, provided the applicant causes no delays during prosecution. Patents in most other countries have a term of 20 years from the date of filing the patent application. Our issued United States patents will expire between 2009 and 2019. We intend to continue to file patent applications as we develop new products, technologies and patentable enhancements. Prosecution practices have been implemented to avoid any applicant delays that could compromise the 17-year minimum term. There can be no guarantee that such procedures will prevent the loss of a potential patent term. This is particularly true in the short-term as the patent rules implementing the most recent patent term changes are largely new and untested.
Complex legal and factual determinations and evolving law make patent protection uncertain. As a result, we cannot be certain that patents will be issued from any of our pending patent applications or from applications licensed to us or that any issued patents will have sufficient breadth to offer meaningful protection. In addition, our issued patents may be successfully challenged, invalidated, circumvented or rendered unenforceable so that our patent rights would not create an effective competitive barrier. Moreover, the laws of some foreign countries may not protect our proprietary rights to the same extent as do the United States patent laws.
In addition to patent protection, we rely on trade secret protection of our intellectual property. We attempt to protect our trade secrets by entering into confidentiality agreements with third parties, employees and consultants. Our employees and consultants are required to sign agreements to assign to us their interests in discoveries, inventions, patents, trademarks and copyrights arising from their work for us. They also are required to maintain the confidentiality of our intellectual property, and refrain from unfair competition with us during their employment and for a certain amount of time after their employment with us, which includes solicitation of our employees and customers. We cannot be certain these agreements will not be breached or invalidated. In addition, third parties may independently discover or invent competing technologies or reverse engineer our trade secrets or other technologies.
In the future, we may become involved in lawsuits in which third parties file claims asserting that our technologies or products infringe on their intellectual property. We cannot predict whether third parties will assert such claims against us or against the licensors of technologies licensed to us, or our licensees, or whether those claims will hurt our business. We may be forced to defend against such claims, whether they are with or without merit or whether they are resolved in favor of or against our licensors, or us and may face costly litigation and diversion of Management’s attention and resources. As a result of such disputes, we may have to develop costly non-infringing technologies or enter into licensing agreements. These agreements may oblige us to accept costly terms, which could seriously limit the ability to conduct our operations and affect adversely our financial condition.
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In addition, we may become involved in lawsuits in which third parties file claims asserting that one or more of our patents are invalid. We cannot predict whether third parties will assert such claims against us or against the licensees of such patents, or whether those claims will have an adverse impact on our business. We may be forced to defend against such claims, whether they are with or without merit or whether they are resolved in favor of or against our licensees, or us and may face costly litigation and diversion of Management’s attention. During the period from February 2001 through March 31, 2002, we had in place a patent insurance policy, placed with GE Reinsurance Corporation through Dexta Corporation Limited, their managing general agents in Australia. Although the policy was not renewed on its expiry, since we had advised Dexta of 13 companies prior to March 31, 2002 as potential infringers, a significant portion of our expenses incurred to date relating to the prosecution of our claims have been covered by the policy.
Of those 13 so identified, we have secured licenses with six, relinquished our claims against four and commenced proceedings against Applera, Covance and Nuvello. The suits against Covance and Nuvello were subsequently settled. On December 12, 2005, we announced the final settlement of our patent dispute with Applera Corporation, further to a settlement conference held in San Francisco, California. The parties had executed a number of binding agreements, including a final Settlement Agreement plus license agreements and a supply agreement and, subsequently, they jointly applied to Northern California District Court requesting that all claims and counterclaims in the legal action be dismissed forthwith. The total value of the consideration receivable by us is approximately AUD15 million, payable partly in cash and partly in kind, including agreements supplying the Company with certain Applera equipment, reagents and intellectual property rights. Recognition of in-kind consideration as revenue is subject to us meeting certain revenue recognition criteria including, but not limited to, the measurement of fair value at the time of receipt.
Our Patents
Our current patent portfolio is described below. “Numbers” refers to either application, publication or patent number.
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NON-CODING DNA |
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Intron sequence analysis method for detection of adjacent and remote locus alleles as haplotypes |
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Earliest priority August 25, 1989 |
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AU654111 |
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AU672519 |
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EP414469 |
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EP414469 |
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EP414469 |
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SG47747 |
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Genomic mapping method by direct haplotyping using intron sequence analysis |
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Earliest priority July 11, 1990 |
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AU647806 |
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EP570371 |
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Compositions and methods of use of variable number of tandem repeats (VNTRs) |
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Earliest priority October 3, 2003 |
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Markers of predisposition to addictive states |
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LABORATORY TECHNIQUES |
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Internal standard for electrophoretic separations |
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Earliest priority July 11, 1990 |
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Genetic analysis |
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Earliest priority November 1, 1991 |
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EP660877 |
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EP660877 |
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EP660877 |
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Method for determining ancestral haplotypes using haplospecific geometric elements within the major histocompatability complex multigene cluster |
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Earliest priority November 1, 1991 |
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US6383747 |
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Methods of genetic analysis involving the amplification of complementary duplicons |
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Earliest priority February 16, 2005 |
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WO2006086846 |
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Identification of ancestral haplotypes and uses thereof |
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Earliest priority August 24, 2005 |
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PCT/AU2006/001232 |
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ATHLETIC PERFORMANCE |
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ACTN3 genotype screen for athletic performance |
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|
|
|
|
|
|
|
Earliest priority September 16, 2002 |
|
Australia |
|
AU2003258390 |
|
|
|
· |
|
|
|
Canada |
|
CA2499084 |
|
|
|
· |
|
|
|
China |
|
CN1732270 |
|
|
|
· |
|
|
|
Europe |
|
EP1546403 |
|
|
|
· |
|
|
|
India |
|
599/KOLNP/2005 |
|
|
|
· |
|
|
|
Japan |
|
JP2005538710 |
|
|
|
· |
|
|
|
New Zealand |
|
NZ538890 |
|
|
|
· |
|
|
|
Russia |
|
RU2005111236 |
|
|
|
· |
|
|
|
South Korea |
|
KR1020057004536 |
|
|
|
· |
|
|
|
United States |
|
US2006121478 |
|
|
|
· |
|
|
|
|
|
|
|
|
|
|
|
IMMUNAID PROJECT |
|
|
|
|
|
|
|
|
|
A retroviral immunotherapy |
|
|
|
|
|
|
|
|
|
Earliest priority August 18, 2000 |
|
Australia |
|
AU2003200583 |
|
· |
|
|
|
|
|
New Zealand |
|
NZ524280 |
|
· |
|
|
|
|
|
Singapore |
|
SG95523 |
|
· |
|
|
|
|
|
South Africa |
|
ZA200301694 |
|
· |
|
|
|
|
|
Brazil |
|
BR0113354 |
|
|
|
· |
|
|
|
Canada |
|
CA2431954 |
|
|
|
· |
|
|
|
China |
|
CN1469746 |
|
|
|
· |
|
|
|
Europe |
|
EP1311267 |
|
|
|
· |
|
|
|
Japan |
|
JP2004506015 |
|
|
|
· |
|
|
|
United States |
|
US20030228320 |
|
|
|
· |
21
|
|
|
COUNTRY / REGION |
|
NUMBERS |
|
GRANTED |
|
PENDING |
|
Cancer therapy |
|
|
|
|
|
|
|
|
|
Earliest priority February 14, 2002 |
|
Singapore |
|
SG105902 |
|
· |
|
|
|
|
|
South Africa |
|
ZA200407142 |
|
· |
|
|
|
|
|
Australia |
|
AU2003203051 |
|
|
|
· |
|
|
|
Brazil |
|
BR0307661 |
|
|
|
· |
|
|
|
Canada |
|
CA2476366 |
|
|
|
· |
|
|
|
China |
|
CN1646155 |
|
|
|
· |
|
|
|
Europe |
|
EP1482970 |
|
|
|
· |
|
|
|
Japan |
|
JP2005523277 |
|
|
|
· |
|
|
|
New Zealand |
|
NZ534570 |
|
|
|
· |
|
|
|
United States |
|
US2005180971 |
|
|
|
· |
|
|
|
|
|
|
|
|
|
|
|
Strategy for retroviral immunotherapy |
|
|
|
|
|
|
|
|
|
Earliest priority February 20, 2002 |
|
Singapore |
|
SG105903 |
|
· |
|
|
|
|
|
South Africa |
|
ZA200407143 |
|
· |
|
|
|
|
|
Brazil |
|
BR0307868 |
|
|
|
· |
|
|
|
Canada |
|
CA2476956 |
|
|
|
· |
|
|
|
China |
|
CN1646156 |
|
|
|
· |
|
|
|
Europe |
|
EP1482971 |
|
|
|
· |
|
|
|
Japan |
|
JP2005526729 |
|
|
|
· |
|
|
|
New Zealand |
|
NZ534590 |
|
|
|
· |
|
|
|
|
|
|
|
|
|
|
|
Method of therapy |
|
|
|
|
|
|
|
|
|
Earliest priority October 24, 2003 |
|
Australia |
|
AU2004283322 |
|
|
|
· |
|
|
|
Brazil |
|
BR04155335 |
|
|
|
· |
|
|
|
Canada |
|
CA2543490 |
|
|
|
· |
|
|
|
China |
|
CN2004838999 |
|
|
|
· |
|
|
|
Europe |
|
EP1692516 |
|
|
|
· |
|
|
|
Israel |
|
IL175141 |
|
|
|
· |
|
|
|
Japan |
|
2006535913 |
|
|
|
· |
|
|
|
Mexico |
|
PA/a/2006/004522 |
|
|
|
· |
|
|
|
New Zealand |
|
546873 |
|
|
|
· |
|
|
|
Russia |
|
RU200611793 |
|
|
|
· |
|
|
|
Singapore |
|
SG121609 |
|
|
|
· |
|
|
|
Ukraine |
|
UK200605663 |
|
|
|
· |
|
|
|
United States |
|
US10/576981 |
|
|
|
· |
|
|
|
World |
|
WO2005040816 |
|
|
|
· |
|
|
|
|
|
|
|
|
|
|
|
Therapeutic
strategy for treating |
|
|
|
|
|
|
|
|
|
Earliest priority September 8, 2004 |
|
World |
|
WO2006026821 |
|
|
|
· |
|
|
|
|
|
|
|
|
|
|
|
PATHOGENS PROJECT |
|
|
|
|
|
|
|
|
|
High
resolution analysis of genetic |
|
|
|
|
|
|
|
|
|
Earliest priority August 21, 2002 |
|
Australia |
|
AU2003250619 |
|
|
|
· |
|
|
|
Brazil |
|
BR03137082 |
|
|
|
· |
|
|
|
Canada |
|
CA2496472 |
|
|
|
· |
|
|
|
China |
|
CN1681940 |
|
|
|
· |
|
|
|
Europe |
|
EP1543149 |
|
|
|
· |
|
|
|
Hong Kong |
|
HK1076295 |
|
|
|
· |
|
|
|
Japan |
|
JP2004529588 |
|
|
|
· |
|
|
|
Mexico |
|
MXPA05002027 |
|
|
|
· |
|
|
|
New Zealand |
|
NZ538418 |
|
|
|
· |
|
|
|
United States |
|
US2002950977 |
|
|
|
· |
22
|
|
|
COUNTRY / REGION |
|
NUMBERS |
|
GRANTED |
|
PENDING |
|
PATHOGENS PROJECT |
|
|
|
|
|
|
|
|
|
Compounds, compositions and methods for controlling invertebrate pests |
|
|
|
|
|
|
|
|
|
Earliest priority November 15, 2006 |
|
Australia |
|
AU2006906383 |
|
|
|
· |
|
|
|
|
|
|
|
|
|
|
|
RARECELLECT® PROJECT |
|
|
|
|
|
|
|
|
|
Fetal cell recovery method |
|
|
|
|
|
|
|
|
|
Earliest priority March 27, 1990 |
|
Australia |
|
AU649027 |
|
· |
|
|
|
|
|
Austria |
|
AT194166 |
|
· |
|
|
|
|
|
Belgium |
|
EP521909 |
|
· |
|
|
|
|
|
Canada |
|
CA2059554 |
|
· |
|
|
|
|
|
Denmark |
|
DK521909 |
|
· |
|
|
|
|
|
Europe |
|
EP521909 |
|
· |
|
|
|
|
|
France |
|
EP521909 |
|
· |
|
|
|
|
|
Germany |
|
DE69132269 |
|
· |
|
|
|
|
|
Great Britain |
|
EP521909 |
|
· |
|
|
|
|
|
Greece |
|
GR3034487 |
|
· |
|
|
|
|
|
Ireland |
|
IE83199 |
|
· |
|
|
|
|
|
Israel |
|
IL97677 |
|
· |
|
|
|
|
|
Italy |
|
EP521909 |
|
· |
|
|
|
|
|
Japan |
|
JP2965699 |
|
· |
|
|
|
|
|
Liechtenstein |
|
EP521909 |
|
· |
|
|
|
|
|
Luxemburg |
|
EP521909 |
|
· |
|
|
|
|
|
Netherlands |
|
EP521909 |
|
· |
|
|
|
|
|
New Zealand |
|
NZ237589 |
|
· |
|
|
|
|
|
Singapore |
|
SG79188 |
|
· |
|
|
|
|
|
South Africa |
|
ZA9102317 |
|
· |
|
|
|
|
|
Spain |
|
ES2149760 |
|
· |
|
|
|
|
|
Sweden |
|
EP521909 |
|
· |
|
|
|
|
|
Switzerland |
|
EP521909 |
|
· |
|
|
|
|
|
United States |
|
US5447842 |
|
· |
|
|
|
|
|
|
|
US5153117 |
|
· |
|
|
|
|
|
|
|
|
|
|
|
|
|
Maternal antibodies as fetal cell markers to identify and enrich fetal cells from maternal blood |
|
|
|
|
|
|
|
|
|
Earliest priority May 30, 2002 |
|
Australia |
|
AU2003229397 |
|
|
|
· |
|
|
|
Canada |
|
CA2492631 |
|
|
|
· |
|
|
|
Europe |
|
EP1532453 |
|
|
|
· |
|
|
|
Hong Kong |
|
HK1075699 |
|
|
|
· |
|
|
|
Japan |
|
JP2004509429 |
|
|
|
· |
|
|
|
New Zealand |
|
NZ537328 |
|
|
|
· |
|
|
|
Singapore |
|
SG108133 |
|
· |
|
|
|
|
|
United States |
|
US20050287604 |
|
|
|
· |
|
|
|
World |
|
WO03102595 |
|
|
|
· |
|
|
|
|
|
|
|
|
|
|
|
Identification of fetal DNA and fetal cell markers in maternal plasma or serum |
|
|
|
|
|
|
|
|
|
Earliest priority March 5, 2003 |
|
Australia |
|
AU2004217872 |
|
|
|
· |
|
|
|
Europe |
|
EP1599608 |
|
|
|
· |
|
|
|
Hong Kong |
|
HK1079245 |
|
|
|
· |
|
|
|
New Zealand |
|
NZ542143 |
|
|
|
· |
|
|
|
United States |
|
US10547721 |
|
|
|
· |
|
|
|
|
|
|
|
|