e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF
1934 |
For the quarterly period ended June 30, 2006
OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF
1934 |
For the transition period from to
Commission file number 000-30171
SANGAMO BIOSCIENCES, INC.
(exact name of small business issuer as specified in its charter)
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Delaware
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68-0359556 |
(State or other jurisdiction of incorporation or organization)
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(IRS Employer Identification No.) |
501 Canal Blvd, Suite A100
Richmond, California 94804
(Address of principal executive offices)
(510) 970-6000
(Registrants telephone number, including area code)
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 Act of 1934 during the preceding 12 months (or for such
shorter period that the registrant was required to file such reports), and (2) has been subject to
such filing requirements for the past 90 days:
Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act.
Large accelerated filer o Accelerated filer þ Non-accelerated filer o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act).
Yes o No þ
As
of August 3, 2006, 33,938,885 shares of the issuers common stock, par value $0.01 per
share, were outstanding.
INDEX
SANGAMO BIOSCIENCES, INC.
Some statements contained in this report are forward-looking with respect to our operations,
research and development activities, operating results and financial condition. Statements that are
forward-looking in nature should be read with caution because they involve risks and uncertainties,
which are included, for example, in specific and general discussions about:
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our strategy; |
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product development and commercialization of our products; |
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clinical trials; |
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revenues from existing and new collaborations; |
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sufficiency of our cash resources; |
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our research and development and other expenses; |
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our operational and legal risks; and |
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our plans, objectives, expectations and intentions and any other statements that are not historical facts. |
Various terms and expressions similar to them are intended to identify these cautionary statements.
These terms include: anticipates, believes, continues, could, estimates, expects,
intends, may, plans, seeks, should and will. Actual results may differ materially from
those expressed or implied in those statements. Factors that could cause these differences include,
but are not limited to, those discussed under Risk Factors and Managements Discussion and
Analysis of Financial Condition and Results of Operations. Sangamo undertakes no obligation to
publicly release any revisions to forward-looking statements to reflect events or circumstances
arising after the date of this report. Readers are cautioned not to place undue reliance on the
forward-looking statements, which speak only as of the date of this Quarterly Report.
2
PART 1. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
SANGAMO BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
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June 30, |
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December 31, |
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2006 |
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2005 (1) |
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(unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
28,838 |
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$ |
18,507 |
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Marketable securities |
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30,330 |
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28,449 |
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Interest receivable |
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170 |
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218 |
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Accounts receivable |
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228 |
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971 |
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Prepaid expenses |
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665 |
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317 |
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Total current assets |
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60,231 |
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48,462 |
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Property and equipment, net |
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517 |
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472 |
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Other assets |
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49 |
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49 |
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Total assets |
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$ |
60,797 |
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$ |
48,983 |
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Liabilities and stockholders equity |
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Current liabilities: |
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Accounts payable and accrued liabilities |
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$ |
953 |
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$ |
1,534 |
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Accrued compensation and employee benefits |
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602 |
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933 |
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Deferred revenue |
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2,983 |
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4,327 |
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Total current liabilities |
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4,538 |
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6,794 |
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Deferred revenue, non-current portion |
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3,125 |
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4,375 |
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Total liabilities |
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7,663 |
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11,169 |
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Stockholders equity: |
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Common stock, $0.01 par value; 80,000,000
shares authorized, 33,938,593 and 30,570,912
shares issued and outstanding at June 30,
2006 and December 31, 2005, respectively |
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34 |
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31 |
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Additional paid-in capital |
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169,548 |
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148,131 |
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Accumulated deficit |
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(116,479 |
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(110,408 |
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Accumulated other comprehensive income |
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31 |
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60 |
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Total stockholders equity |
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53,134 |
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37,814 |
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Total liabilities and stockholders equity |
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$ |
60,797 |
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$ |
48,983 |
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(1) |
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Amounts derived from Audited Consolidated Financial Statements dated December 31, 2005 filed
as a part of our 2005 Form 10-K. |
See accompanying notes.
3
SANGAMO BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
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Three months ended |
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Six months ended |
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June 30, |
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June 30, |
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2006 |
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2005 |
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2006 |
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2005 |
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Revenues: |
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Collaboration agreements |
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$ |
1,431 |
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$ |
353 |
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$ |
3,304 |
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$ |
533 |
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Federal government research grants |
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346 |
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65 |
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609 |
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141 |
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Total revenues |
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1,777 |
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418 |
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3,913 |
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674 |
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Operating expenses: |
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Research and development |
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4,028 |
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2,624 |
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7,617 |
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5,221 |
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General and administrative |
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1,821 |
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1,250 |
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3,576 |
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2,489 |
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Total operating expenses |
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5,849 |
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3,874 |
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11,193 |
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7,710 |
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Loss from operations |
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(4,072 |
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(3,456 |
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(7,280 |
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(7,036 |
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Interest and other income, net |
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745 |
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76 |
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1,209 |
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103 |
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Net loss |
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$ |
(3,327 |
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$ |
(3,380 |
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$ |
(6,071 |
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$ |
(6,933 |
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Basic and diluted net loss per share |
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$ |
(0.11 |
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$ |
(0.13 |
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$ |
(0.20 |
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$ |
(0.27 |
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Shares used in computing basic and diluted net loss per share |
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31,312 |
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25,391 |
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30,959 |
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25,364 |
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See accompanying notes.
4
SANGAMO BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
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Six months ended |
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June 30, |
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2006 |
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2005 |
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Operating Activities: |
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Net loss |
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$ |
(6,071 |
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$ |
(6,933 |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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92 |
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149 |
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Amortization of (premium) / discount on investments |
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(108 |
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191 |
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Realized (gain) / loss on investments |
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(29 |
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41 |
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Stock-based compensation |
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950 |
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186 |
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Changes in operating assets and liabilities: |
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Interest receivable |
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48 |
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33 |
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Accounts receivable |
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743 |
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342 |
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Prepaid expenses and other assets |
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(348 |
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(419 |
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Accounts payable and accrued liabilities |
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(581 |
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(444 |
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Accrued compensation and employee benefits |
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(331 |
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(182 |
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Deferred revenue |
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(2,594 |
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(306 |
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Net cash used in operating activities |
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(8,229 |
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(7,342 |
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Investing Activities: |
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Purchases of investments |
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(16,016 |
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(8,852 |
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Maturities of investments |
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14,243 |
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15,218 |
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Purchases of property and equipment |
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(137 |
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(181 |
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Net cash provided by / (used in) investing activities |
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(1,910 |
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6,185 |
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Financing Activities: |
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Proceeds from issuance of common stock |
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20,470 |
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239 |
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Net cash provided by financing activities |
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20,470 |
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239 |
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Net decrease in cash and cash equivalents |
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10,331 |
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(918 |
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Cash and cash equivalents, beginning of period |
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18,507 |
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8,626 |
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Cash and cash equivalents, end of period |
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$ |
28,838 |
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$ |
7,708 |
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See accompanying notes.
5
SANGAMO BIOSCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
June 30, 2006
NOTE 1-BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
BASIS OF PRESENTATION
The accompanying unaudited condensed consolidated financial statements of Sangamo Biosciences,
Inc. (Sangamo or the Company) have been prepared in accordance with generally accepted
accounting principles for interim financial information and pursuant to the rules and regulations
of the Securities and Exchange Commission (SEC). Accordingly, they do not include all of the
information and footnotes required by generally accepted accounting principles for complete
financial statements. In the opinion of management, all adjustments (consisting of normal recurring
adjustments) considered necessary for a fair presentation have been included. The condensed
consolidated financial statements include the accounts of Sangamo and its wholly-owned subsidiary,
Gendaq Limited, after elimination of all material intercompany balances and transactions. Operating
results for the six months ended June 30, 2006 are not necessarily indicative of the results that
may be expected for the year ending December 31, 2006. These financial statements should be read in
conjunction with the financial statements and footnotes thereto for the year ended December 31,
2005, included in Sangamos Form 10-K as filed with the SEC.
USE OF ESTIMATES
The preparation of financial statements in conformity with generally accepted accounting
principles requires management to make estimates and assumptions that affect the amounts reported
in the financial statements and the accompanying notes. Actual results could differ from those
estimates.
Certain reclassifications of prior period amounts have been made to the Condensed Consolidated
Financial Statements to conform to the current period presentation, including the reclassification
of patent prosecution expenses to general and administrative expense from research and development
expense. The reclassifications were immaterial and had no impact on the Companys net loss or
accumulated deficit.
FOREIGN CURRENCY TRANSLATION
The Company records foreign currency transactions at the exchange rate prevailing at the date
of the transaction. Monetary assets and liabilities denominated in foreign currency are translated
into U.S. dollars at the exchange rates in effect at the balance sheet date. All currency
translation adjustments arising from foreign currency transactions are recorded through profit and
loss.
REVENUE RECOGNITION
In accordance
with Staff Accounting Bulletin No. 104, Revenue Recognition, revenue from
research activities made under strategic partnering collaborations is recognized as the services are
provided when there is persuasive evidence that an arrangement exists, delivery has occurred, the
price is fixed or determinable, and collectibility is reasonably assured. Amounts received in
advance under such agreements are deferred until the above criteria are met and the research
services are performed. Sangamos federal government research grants are typically multi-year
agreements and provide for the reimbursement of qualified expenses for research and development as
defined under the terms of the grant agreement. Revenue under grant agreements is recognized when
the related qualified research expenses are incurred. Grant reimbursements are received on a
quarterly or monthly basis and are subject to the issuing agencys right of audit.
Sangamo
recognizes revenue from its Therapeutic and Enabling Technology collaborations when
zinc finger DNA-binding protein (ZFP)-based products are delivered to the collaborators, persuasive evidence of an agreement exists,
there are no unfulfilled obligations, the price is fixed and determinable, and collectibility is
reasonably assured. Generally, Sangamo receives partial payments from these collaborations prior to
the delivery of ZFP-based products and the recognition of these revenues is deferred until the
ZFP-based products are delivered, the risk of ownership has passed to the collaborator and all
performance obligations have been satisfied. Upfront or signature payments received upon the
signing of an Enabling Technology agreement are generally recognized ratably over the applicable
period of the agreement, which currently ranges between 12 and 15 months, or as ZFP-based products
are delivered.
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Milestone payments under research, partnering, or licensing agreements are recognized as
revenue upon the achievement of mutually agreed upon milestones, provided that (i) the milestone
event is substantive and its achievement is not reasonably assured at the inception of the
agreement, and (ii) there are no performance obligations associated with the milestone payment.
In accordance with Emerging Issues Task Force Issue No. 00-21, Revenue Arrangements with
Multiple Deliverables, revenue arrangements entered into after June 15, 2003, that include
multiple deliverables are divided into separate units of accounting if the deliverables meet
certain criteria, including whether the fair value of the delivered items can be determined and
whether there is evidence of fair value of the undelivered items. In addition, the consideration is
allocated among the separate units of accounting based on their fair values, and the applicable
revenue recognition criteria are considered separately for each of the separate units of
accounting.
RESEARCH AND DEVELOPMENT EXPENSES
Research and development expenses consist of costs incurred for Company-sponsored as well as
collaborative research and development activities. These costs include direct and research-related
overhead expenses, which include salaries and other personnel-related expenses, stock-based
compensation, facility costs, supplies and depreciation of facilities and laboratory equipment, as
well as the cost of funding research at universities and other research institutions, and are
expensed as incurred. Costs to acquire technologies that are utilized in research and development
and that have no alternative future use are expensed as incurred.
STOCK-BASED COMPENSATION
Prior to January 1, 2006, the Company accounted for our stock-based employee compensation
arrangements under the intrinsic value method prescribed by Accounting Principles Board Opinion No.
25, Accounting for Stock Issued to Employees (APB No. 25), as allowed by SFAS No. 123, Accounting
for Stock-based Compensation (SFAS No. 123), as amended by SFAS No. 148, Accounting for Stock-Based
Compensation Transition and Disclosure (SFAS No. 148). As a result, no expense was recognized for
options to purchase our common stock that were granted with an exercise price equal to fair market
value at the date of grant and no expense was recognized in connection with purchases under our
employee stock purchase plan for the years ended December 31, 2005 or 2004. In December 2004, the
Financial Accounting Standards Board (FASB) issued SFAS No. 123 (revised 2004) Share-Based Payment
(SFAS No. 123R), which replaces SFAS No. 123 and supersedes APB No. 25. SFAS No. 123R requires all
share-based payments to employees, including grants of employee stock options, to be recognized in
the financial statements based on their fair values beginning with the first interim or annual
period after June 15, 2005. Subsequent to the effective date, the pro forma disclosures previously
permitted under SFAS No. 123 are no longer an alternative to financial statement recognition.
Effective January 1, 2006, the Company has adopted SFAS No. 123R using the modified prospective
method. Under this method, compensation cost recognized includes: (a) compensation cost for all
share-based payments granted prior to, but not yet vested as of December 31, 2005, based on the
grant date fair value estimated in accordance with the original provisions of SFAS No. 123
amortized on an accelerated basis over the options vesting period, and (b) compensation cost for
all share-based payments granted subsequent to December 31, 2005, based on the grant-date fair
value estimated in accordance with the provisions of SFAS No. 123R amortized on a straight-line
basis over the options vesting period. Results for prior periods have not been restated. As a
result of adopting SFAS No. 123R on January 1, 2006, the net loss is greater by $ 494,000 and
$924,000 for the three-month period and six-month period ended June 30, 2006, respectively than had
the Company continued to account for stock-based employee compensation under APB No. 25. Basic and
diluted net loss per share for the three-month period and six-month period ended June 30, 2006 are
$0.02 and $0.03 greater, respectively, than if the Company had continued to account for stock-based
compensation under APB No. 25. The adoption of SFAS No. 123R had no impact on cash flows from
operations or financing.
Stock Option Plan
Sangamos 2004 Stock Option Plan (the 2004 Option Plan), which supersedes the 2000 Stock Option
Plan, provides for the issuance of common stock and grants of options for common stock to
employees, officers, directors and consultants. The exercise price per share will be no less than
85 percent of the fair value per share of common stock on the option grant date, and the option
term will not exceed ten years. If the person to whom the option is granted is a 10 percent
stockholder, and the option granted qualifies as an Incentive Stock Option Grant, then the exercise
price per share will not be less than 110 percent of the fair value per share of common stock on
the option grant date, and the option term will not exceed five years. Options granted under the
2004 Option Plan generally vest over four years at a rate of 25 percent one year from the grant
date and one thirty-sixth per month thereafter and expire ten years after the grant, or earlier
upon employment termination. Options granted pursuant to the 2004 Option Plan may be exercised
prior to vesting, with the related shares subject to Sangamos right to repurchase the shares that
have not vested at the issue price if the option
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holder terminates employment. The right of repurchase lapses over the original option vesting
period, as described above. A total of 6.5 million shares are reserved for issuance pursuant to the
2004 Option Plan. The number of shares authorized for issuance automatically increases on the first
trading day of the fiscal year by an amount equal to 3.0 percent of the total number of shares of
our common stock outstanding on the last trading day of the preceding fiscal year.
Employee Stock Purchase Plan
The Board of Directors adopted the 2000 Employee Stock Purchase Plan in February 2000, effective
upon the completion of Sangamos initial public offering of its common stock. Sangamo reserved a
total of 400,000 shares of common stock for issuance under the plan. Eligible employees may
purchase common stock at 85 percent of the lesser of the fair market value of Sangamos common
stock on the first day of the applicable two-year offering period or the last day of the applicable
six-month purchase period. The reserve for shares available under the plan will automatically
increase on the first trading day of the second fiscal quarter each year, beginning in 2001, by an
amount equal to 1 percent of the total number of outstanding shares of our common stock on the last
trading day of the immediately preceding first fiscal quarter.
As of June 30, 2006, total shares reserved for future awards under all plans were 8,274,664.
Adoption of FAS 123R
Employee stock-based compensation expense recognized in 2006 was calculated based on awards
ultimately expected to vest and has been reduced for estimated forfeitures. FAS 123R requires
forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods
if actual forfeitures differ from those estimates. A forfeiture rate of 10% is applied to the
stock-based compensation expense, determined through historical experience of employee stock option
exercises. The following table shows total stock-based employee compensation expense (see above for
types of stock-based employee arrangements) included in the condensed consolidated statement of
operations for the three-month and six-month periods ended June 30, 2006 (in thousands):
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Three months ended |
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Six months ended |
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June 30, 2006 |
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June 30, 2006 |
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Costs and expenses: |
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Research and development |
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$ |
310 |
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$ |
627 |
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General and administrative |
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184 |
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297 |
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Total stock-based compensation expense |
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$ |
494 |
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$ |
924 |
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There was no capitalized stock-based employee compensation cost as of June 30, 2006. There were no
recognized tax benefits during the six months ended June 30, 2006.
As of June 30, 2006, total compensation cost related to nonvested stock options to be recognized in
future periods was $3.47 million, which is expected to be expensed over a weighted average period
of 48 months.
Pro Forma Information for Period Prior to Adoption of FAS 123R
The following table illustrates the effect on net loss and net loss per share had we applied the
fair value recognition provisions of SFAS No. 123 to account for our employee stock option and
employee stock purchase plans for the three-month and six-month period ended June 30, 2005 because
stock-based employee compensation was not accounted for using the fair value recognition method
during that period. For purposes of pro forma disclosure, the estimated fair value of the stock
awards, as prescribed by SFAS No. 123, is amortized to expense over the vesting period of such
awards (in thousands, except per share data).
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Six months ended |
|
|
|
June 30, 2005 |
|
|
June 30, 2005 (1) |
|
Net loss, as reported |
|
$ |
(3,380 |
) |
|
$ |
(6,933 |
) |
Deduct: Total stock-based employee
compensation expense determined
under fair value method |
|
|
(667 |
) |
|
|
(1,214 |
) |
|
|
|
|
|
|
|
Pro forma net loss |
|
$ |
(4,047 |
) |
|
$ |
(8,147 |
) |
|
|
|
|
|
|
|
Basic and diluted net loss per share: |
|
|
|
|
|
|
|
|
As reported |
|
$ |
(0.13 |
) |
|
$ |
(0.27 |
) |
|
|
|
|
|
|
|
Pro forma |
|
$ |
(0.16 |
) |
|
$ |
(0.32 |
) |
|
|
|
|
|
|
|
8
|
|
|
(1) |
|
During the preparation of footnotes to the condensed consolidated financial statements for
our quarterly filings during fiscal year 2006, we determined that the calculation of our net
loss pro forma reported under SFAS No. 123 for fiscal year 2005, as reported in that year,
did not appropriately reflect the effect of SFAS No. 123 for certain options granted prior to
January 1, 2006. Accordingly, the amount of net loss pro forma reported under SFAS No. 123
for the first quarter of fiscal 2005 presented in the table above has been revised, resulting
in an increase in the previously reported amount of pro forma net loss of $296,000 or $0.01
per basic and diluted share for three-months period ended June 30, 2005 and $ 635,000 or $
0.02 per basic and diluted share for six-months period ended June 30, 2005, respectively. This
revision had no effect on our previously reported condensed consolidated results of operations
or financial condition. |
The historical pro forma impact of applying the fair value method prescribed by SFAS No. 123 is not
representative of the impact that may be expected in the future due to changes resulting from
additional grants in future years and changes in assumptions such as volatility, interest rates and
expected life used to estimate fair value of the grants in future years.
Valuation Assumptions
The employee stock-based compensation expense recognized under FAS123R and presented in the pro
forma disclosure required under FAS123 was determined using the Black Scholes option valuation
model. Option valuation models require the input of subjective assumptions and these assumptions
can vary over time.
We primarily base our determination of expected volatility through our assessment of the historical
volatility of our Common Stock. We do not believe that we are able to rely on our historical
exercise and post-vested termination activity to provide accurate data for estimating our expected
term for use in determining the fair value of these options. Therefore, as allowed by Staff
Accounting Bulletin (SAB) No. 107, Share-Based Payment , we have opted to use the simplified method
for estimating our expected term equal to the midpoint between the vesting period and the
contractual term.
The weightedaverage assumptions used for estimating the fair value of the employee stock options
are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Six months ended |
|
|
June 30, |
|
June 30, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
Risk-free interest rate |
|
|
5.1 |
% |
|
|
3.7 |
% |
|
|
5.0-5.1 |
% |
|
|
3.8 |
% |
Expected life of option |
|
6.25 years |
|
5.0 years |
|
6.25 years |
|
4.5 years |
Expected dividend yield of stock |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
Expected volatility |
|
|
.97 |
|
|
|
1.0 |
|
|
|
.91-.97 |
|
|
|
1.0 |
|
The expected volatility reported in the quarter ended March 31, 2006 should be 0.91
instead of 0.82 as a result of a computational error. The impact of this change is not material to
the net results of operations and basic and diluted loss per share for the three months and six
months ended June 30, 2006.
The weightedaverage assumptions used for estimating the fair value of
the employees purchase rights are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Six months ended |
|
|
June 30, |
|
June 30, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
Risk-free interest rate |
|
|
4.75-5.17 |
% |
|
|
1.25-3.61 |
% |
|
|
4.75-5.17 |
% |
|
|
1.25-3.61 |
% |
Expected life of option |
|
0.5-2 years |
|
0.5-2 yrs |
|
.5-2 yrs |
|
0.5-2 yrs |
Expected dividend yield of stock |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
Expected volatility |
|
|
.41-.98 |
|
|
|
.52-.78 |
|
|
|
.41-.98 |
|
|
|
.52-.78 |
|
9
Stock Option Activity
A summary of Sangamos stock option activity follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
|
Shares Available |
|
|
|
|
|
|
Weighted-Average |
|
|
Remaining |
|
|
|
for Grant of |
|
|
Number of |
|
|
Exercise per |
|
|
Contractual |
|
|
|
Options |
|
|
Shares |
|
|
Share Price |
|
|
Term |
|
Balance at January 1, 2006 |
|
|
3,256,505 |
|
|
|
3,874,097 |
|
|
$5.30 |
|
|
|
|
|
Options granted |
|
|
(157,500 |
) |
|
|
157,500 |
|
|
$6.74 |
|
|
|
|
|
Options exercised |
|
|
|
|
|
|
(223,122 |
) |
|
$1.57 |
|
|
|
|
|
Options canceled |
|
|
141,857 |
|
|
|
(141,857 |
) |
|
$7.58 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2006 |
|
|
3,240,862 |
|
|
|
3,666,618 |
|
|
$5.50 |
|
|
|
6.36 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at June 30, 2006 |
|
|
|
|
|
|
2,315,078 |
|
|
$6.00 |
|
|
|
5.06 |
|
There were no shares subject to
Sangamos right of repurchase as of June 30, 2006. The intrinsic value of options exercised were $
269,000 and $36,000 for the three months ended June 30, 2006 and 2005 and $1,059,000 and $428,000
for the six months ended June 30, 2006 and 2005, respectively.
The weighted-average estimated
fair value per share of options granted during the three months and six months ended June 30, 2006
and 2005 were $5.80 and $2.95, and $5.44 and $3.10, respectively, based upon the assumptions in the
Black-Scholes valuation model described above.
The weighted-average estimated fair value per
share of employee purchase rights during the three months and six months ended June 30, 2006 and
2005 were $2.23 and $1.16,and $2.17 and $1.24, respectively, based upon the assumptions in the
Black-Scholes valuation model described above.
The following table summarizes information with
respect to stock options outstanding at June 30, 2006:
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding |
|
|
|
|
|
|
|
Weighted Average |
|
|
|
|
|
|
|
Remaining |
|
Range of Exercise Price |
|
Number of Shares |
|
|
Contractual Life |
|
|
|
|
|
|
|
(In Years) |
|
$0.05 - $ 0.15 |
|
|
61,583 |
|
|
|
1.62 |
|
$0.17 - $ 0.17 |
|
|
400,000 |
|
|
|
1.85 |
|
$0.23 - $ 3.61 |
|
|
443,976 |
|
|
|
7.25 |
|
$3.78 - $ 4.08 |
|
|
298,261 |
|
|
|
7.48 |
|
$4.11 - $ 4.11 |
|
|
390,000 |
|
|
|
9.45 |
|
$4.15 - $ 5.18 |
|
|
234,865 |
|
|
|
7.76 |
|
$5.19 - $ 5.19 |
|
|
487,733 |
|
|
|
7.80 |
|
$5.36 - $ 7.13 |
|
|
315,500 |
|
|
|
6.85 |
|
$7.49 - $ 7.49 |
|
|
415,000 |
|
|
|
5.25 |
|
$7.57 - $38.00 |
|
|
619,700 |
|
|
|
5.46 |
|
|
|
|
|
|
|
|
|
|
|
|
3,666,618 |
|
|
|
6.36 |
|
|
|
|
|
|
|
|
|
At June 30, 2006, the aggregate intrinsic values of the outstanding and exercisable options
were $5.8 million and 3.9 million, respectively.
Sangamo granted 15,000 nonqualified common
stock options to consultants during the three months ended June 30, 2005. The Company did not grant
any stock option to consultants during three-months and six-months ended June 30, 2006. The Company
granted 15,000 and 10,000 nonqualified common stock options to consultants at exercise prices that
range from $3.00 to $3.80 per share for services rendered in 2005 and 2004, respectively. Such
options are included in the option tables disclosed above. The options generally vest over four
years at a rate of 25 percent one year from grant date and one-thirty-sixth per month thereafter
and expire ten years after the grant date. Total nonqualified stock-based compensation expense was
$5,000 and $85,000 for the three months period
10
ended June 30, 2006 and 2005 and $26,000 and
$186,000 for the six months period ended June 30, 2006 and 2005, respectively. The fair value of
these options was determined using the Black-Scholes Merton model.
NOTE 2-BASIC AND DILUTED NET LOSS PER SHARE
Basic and diluted net loss per share have been computed using the
weighted-average number of shares of common stock outstanding during the period. Because we are in
a net loss position, diluted earnings per share is also calculated using the weighted average
number of common shares outstanding and excludes the effects of stock options which are all
antidilutive.
NOTE 3-COMPREHENSIVE LOSS
Comprehensive loss is comprised of net loss
and other comprehensive income (loss). Other comprehensive loss includes certain changes in
stockholders equity that are excluded from net loss, which includes unrealized gains and losses on
our available-for-sale securities. Comprehensive loss and its components are as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Six months ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Net loss |
|
$ |
(3,327 |
) |
|
$ |
(3,380 |
) |
|
$ |
(6,071 |
) |
|
$ |
(6,933 |
) |
Changes in
unrealized gain
(loss) on
securities
available-for-sale |
|
|
(18 |
) |
|
|
5 |
|
|
|
(29 |
) |
|
|
63 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(3,345 |
) |
|
$ |
(3,375 |
) |
|
$ |
(6,100 |
) |
|
$ |
(6,870 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
11
NOTE 4-MAJOR CUSTOMERS, PARTNERSHIPS AND STRATEGIC ALLIANCES
Strategic Partnership with Edwards Lifesciences Corporation
In January 2000, we announced a therapeutic product
development collaboration with Edwards Lifesciences Corporation (Edwards). Under the agreement,
we have licensed to Edwards, on a worldwide, exclusive basis, ZFP Therapeutics for use in the
activation of VEGFs and VEGF receptors in ischemic cardiovascular and vascular diseases. Edwards
purchased a $5.0 million note that converted, together with accrued interest, into 333,333 shares
of common stock at the time of our initial public offering (IPO) at the IPO price. In March 2000,
Edwards purchased a $7.5 million convertible note in exchange for a right of first refusal for
three years to negotiate a license for additional ZFP Therapeutics in cardiovascular and peripheral
vascular diseases. That right of first refusal was not exercised and terminated in March 2003.
Together with accrued interest, this note converted into common stock at the time of our initial
public offering at the IPO price. Through 2001, we received $2 million in research funding from
Edwards and a $1.4 million milestone payment for delivery of a lead ZFP Therapeutic product
candidate. In November 2002, Edwards signed an amendment to the original agreement and agreed to
provide up to $3.5 million in research and development funding, including $2.95 million for
research and development activities performed in 2002 and 2003. The filing of the IND for PAD in
2004, and the achievement of other research-related milestones in 2003, triggered a total of $1.0
million in milestone payments from Edwards in the first quarter of 2004. There were no revenues
attributable to milestone achievement and collaborative research and development performed under
the Edwards agreements for both the three-month and six-month periods ended June 30, 2006 and 2005.
Our license agreement with Edwards Lifesciences provides Edwards with worldwide, exclusive rights
for ZFP Therapeutics for the activation of VEGF and VEGF receptors for the treatment and
prevention of ischemic cardiovascular and vascular disease in humans. We have retained all rights
to use our technology for all therapeutic applications of VEGF activation outside of the treatment
and prevention of ischemic cardiovascular and vascular disease in humans. During the first quarter
of 2005, Sangamo commenced a Phase I clinical trial for the treatment of diabetic neuropathy using
a ZFP Therapeutic for the activation of VEGF. Edwards has stated that its rights include diabetic
neuropathy and consequently our activities relating to diabetic neuropathy constitute a breach of
the agreement. We strongly disagree with the Edwards assertion because diabetic neuropathy is a
neurological disease and not an ischemic vascular disease and therefore is outside the scope of the
Edwards license. Sangamo and Edwards are in discussions regarding this issue.
In the future,
Sangamo may receive milestone payments and royalties under this agreement. We have received $2.5
million in milestone payments to date and we could receive up to $27.0 million in additional
milestone payments under the agreement if all future milestones are met for the first product
developed under the agreement. Any subsequent products developed under the agreement may generate
up to $15.0 million in milestone payments each. We would also receive royalties on any sales of
products generated under the agreement and these royalty obligations would continue until the
expiration of the last-to-expire patent covering products developed under the agreement on a
country-by-country basis. Based on currently issued patents, these royalty obligations would last
through January 12, 2019. The development of any products is subject to numerous risks and no
assurance can be given that any products will successfully be developed under this agreement. See
Risk Factors Our gene regulation technology is relatively new, and if we are unable to use this
technology in all our intended applications, it would limit our revenue opportunities.
Under the
Sangamo-Edwards agreement, we were responsible for advancing product candidates into preclinical
animal testing. Edwards had responsibility for preclinical development, regulatory affairs,
clinical development, and the sales and marketing of ZFP Therapeutic products developed under the
agreement. Sangamo may receive milestone payments in connection with the development and
commercialization of the first product under this agreement and may also receive royalties on
product sales. As part of the November 2002 amendment to our original agreement, Edwards also
entered into a joint collaboration with us to evaluate ZFP TFs for the regulation of a second
therapeutic gene target, phospholamban (PLN), for the treatment of congestive heart failure. Under
the amended agreement, Sangamo granted Edwards a right of first refusal to Sangamos ZFP TFs for
the regulation of PLN. This right of first refusal terminated on June 30, 2004. On August 14, 2003,
Edwards and Sangamo entered into a Third Amendment to the original license agreement. Under this
amendment, Sangamo received payment for research and development milestones associated with the
VEGF and PLN programs.
There is no assurance that the companies will achieve the development and
commercialization milestones anticipated in these agreements. Edwards has the right to terminate
the agreement at any time upon 90 days written notice. In the event of termination, we retain all
payments previously received as well as the right to develop and commercialize all related
products.
12
Therapeutic Collaboration with LifeScan for Regenerative Medicine
In September 2004, we announced that we had entered into a research agreement with LifeScan, Inc., a Johnson &
Johnson company. The agreement provides LifeScan with our ZFP TFs for use in a program to develop
therapeutic cell lines as a potential treatment for diabetes. In December 2004, and again in
September 2005, this agreement was expanded to include additional targets important in diabetes.
The agreements represented our first collaboration in the field of regenerative medicine. During
the three months ended June 30, 2006 and 2005, revenues attributable to collaborative research and
development performed under the LifeScan agreements were $150,000 and $55,000, respectively.
Revenues for the six-month periods ended June 30, 2006 and 2005 were $300,000 and $110,000,
respectively. Related research and development costs and expenses performed under the LifeScan
agreements were $24,000 and $19,000 during the three months ended June 30, 2006 and 2005,
respectively. Research and development costs and expenses performed under the LifeScan agreements
were $32,000 and $37,000 during the six months ended June 30, 2006 and 2005, respectively.
Enabling Technology Collaborations for Pharmaceutical Protein Production
We have established
several research collaborations in this area. In December 2004, we announced a research
collaboration agreement with Pfizer Inc to use our ZFP technology to develop enhanced cell lines
for protein pharmaceutical production. The scope of this agreement was expanded in January 2006 and
provided further research funding from Pfizer to develop additional cell lines for enhanced protein
production. Under the terms of the agreement, Pfizer is funding research at Sangamo and Sangamo
will provide our proprietary ZFP technology for Pfizer to assess its feasibility for use in
mammalian cell-based protein production. We are generating novel cell lines and vector systems for
enhanced protein production as well as novel technology for rapid creation of new production cell
lines. Revenues attributable to collaborative research and development performed under the Pfizer
agreement were $157,000 and $298,000 during the three months ended June 30, 2006 and 2005,
respectively. Revenues for the six-month periods ended June 30, 2006 and 2005 were $307,000 and
$423,000, respectively. Related research and development costs and expenses performed under the
Pfizer agreement were $98,000 and $30,000 during the three months ended June 30, 2006 and 2005,
respectively, and $155,000 and $52,000 during the six months ended June 30, 2006 and 2005,
respectively.
Plant Agriculture Agreements
Sangamo scientists and collaborators have shown that
ZFP TFs and ZFP nucleases (ZFNs) can be used to regulate and modify genes in plants with similar
efficacy to that shown in various mammalian cells and organisms. The ability to regulate gene
expression with engineered ZFP TFs may lead to the creation of new plants that increase crop
yields, lower production costs, are more resistant to herbicides, pesticides, and plant pathogens;
and permit the development of branded agricultural products with unique nutritional and processing
characteristics. In addition, ZFNs may be used to facilitate the efficient and reproducible
generation of transgenic plants. Effective as of October 1, 2005, we entered into a Research
License and Commercial Option Agreement with Dow AgroSciences LLC (DAS), a wholly owned indirect
subsidiary of Dow Chemical Corporation. Under this agreement, we will provide DAS with access to
our proprietary ZFP technology and the exclusive right to use our ZFP technology to modify the
genomes or alter the nucleic acid or protein expression of plant cells, plants, or plant cell
cultures. We will retain rights to use plants or plant-derived products to deliver ZFP TFs or ZFNs
into human or animals for diagnostic, therapeutic, or prophylactic purposes.
Our agreement with
DAS provides for an initial three-year research term during which time we will work together to
validate and optimize the application of our ZFP technology to plants, plant cells and plant cell
cultures. A joint committee having equal representation from both companies will oversee this
research. During the initial three-year research term, DAS will have the option to obtain a
commercial license to sell products incorporating or derived from plant cells generated using our
ZFP technology, including agricultural crops, industrial products and plant-derived
biopharmaceuticals. This commercial license will be exclusive for all such products other than
animal and human health products. In the event that DAS exercises this option, DAS may elect to
extend the research program beyond the initial three-year term on a year-to-year basis.
Pursuant
to the Research License and Commercial Option Agreement, DAS made an initial cash payment to us of
$7.5 million and agreed to purchase up to $4.0 million of our common stock in the next financing
transaction meeting certain criteria. In November 2005, the Company sold approximately 1.0 million
shares of common stock to DAS at a price of $3.85 per share, resulting in gross proceeds of $3.9
million. In addition, DAS will provide between $4.0 and $6.0 million in research funding over the
initial three-year research term and may make an additional payment of up to $4.0 million in
research milestone payments to us during this same period, depending on the success of the research
program. In the event that DAS elects to extend the research program beyond the initial three-year
term, DAS will provide additional research funding. If DAS exercises its option to obtain a
commercial license, we will be entitled to full payment of the $4.0 million in research milestones,
a one-time exercise fee of $6.0 million, minimum annual
13
payments of up to $25.25 million,
development and commercialization milestone payments for each product, and royalties on sales of
products. Furthermore, DAS will have the right to sublicense our ZFP technology to third parties
for use in plant cells, plants, or plant cell cultures, and we will be entitled to 25% of any cash
consideration received by DAS under such sublicenses.
We have agreed to supply DAS and
its sublicensees with ZFP TFs and/or ZFNs for both research and commercial use. If DAS exercises
its option to obtain a commercial license, DAS may request that we transfer, at DASs expense, the
ZFP manufacturing technology to DAS or to a mutually agreed-upon contract manufacturer.
The Research License and Commercial Option Agreement will terminate automatically if DAS fails
to exercise its option for a commercial license by the end of the initial three-year research term.
DAS may also terminate the agreement at the end of the second year of the initial research term if
the joint committee overseeing the research determines that disappointing research results have
made it unlikely that DAS will exercise the option; we are guaranteed to receive $4.0 million in
research funding from DAS prior to such a termination. Following DASs exercise of the option and
payment of the exercise fee, DAS may terminate the agreement at any time. In addition, each party
may terminate the agreement upon an uncured material breach of the
other party. In the event of any termination of the agreement, all rights to use our ZFP technology
will revert to us, and DAS will no longer be permitted to practice our ZFP technology or to develop
or, except in limited circumstances, commercialize any products derived from our ZFP technology.
Revenues related to the research license under the DAS agreement are being recognized ratably over
the initial three-year research term of the agreement and were $625,000 during the three months
ended June 30, 2006 and $1.3 million during the six months ended June 30, 2006. Revenues
attributable to collaborative research and development performed under the DAS agreement were
$500,000 during the three months ended June 30, 2006 and $1.5 million during the six months ended
June 30, 2006. Related costs and expenses incurred under the DAS agreement were $500,000 during
the three months ended June 30, 2006 and $1.4 million during the six months ended June 30, 2006.
NOTE 5-STOCKHOLDERS EQUITY
In June 2006, in an underwritten public offering and pursuant to an
effective registration statement, we sold 3,100,000 shares of common stock at a public offering
price of $6.75 per share, resulting in net proceeds of approximately $20.15 million after deducting
underwriters discount.
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
The discussion in Managements Discussion and
Analysis of Financial Condition and Results of Operations contains trend analysis, estimates and
other forward-looking statements within the meaning of Section 27A of the Securities Act of 1933,
as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These
forward-looking statements include, without limitation, statements containing the words believes,
anticipates, expects, continue, and other words of similar import or the negative of those
terms or expressions. Such forward-looking statements are subject to known and unknown risks,
uncertainties, estimates and other factors that may cause the actual results, performance or
achievements of the Company, or industry results, to be materially different from any future
results, performance or achievements expressed or implied by such forward-looking statements.
Actual results could differ materially from those set forth in such forward-looking statements as a
result of, but not limited to, the Risk Factors described below. You should read the following
discussion and analysis along with the financial statements and notes attached to those statements
included elsewhere in this report and in our annual report on Form 10-K for the year ended December
31, 2005 as filed with the Securities and Exchange Commission on March 13, 2006.
Overview
We were incorporated in June 1995. From our inception through June 30, 2006, our
activities related primarily to establishing and operating a biotechnology research and development
organization and developing relationships with our corporate collaborators. Our scientific and
business development endeavors currently focus on the engineering of novel zinc finger DNA binding
proteins (ZFPs) for the regulation and modification of genes. We have incurred net losses since
inception and expect to incur losses in the future as we continue our research and development
activities. To date, we have funded our operations primarily through the issuance of equity
securities, borrowings, payments from federal government research grants and from corporate
collaborators and strategic partners. As of June 30, 2006, we had an accumulated deficit of $116.5
million.
Our revenues have consisted primarily of revenues from our corporate partners
for ZFP TFs and ZFNs, contractual payments from strategic partners for research programs and
research milestones, and Federal government research grant funding. We expect revenues
14
will
continue to fluctuate from period to period and there can be no assurance that new collaborations
or partner fundings will continue beyond their initial terms.
Commencing in 2005, we have
placed more emphasis on higher-value therapeutic product development and related strategic
partnerships and less emphasis on our Enabling Technology collaborations. We believe this shift in
emphasis has the potential to increase the return on investment to our stockholders by allocating
capital resources to higher value, therapeutic product development activities. At the same time, it
may reduce our revenues over the next several years and it increases our financial risk by
increasing expenses associated with product development. We have filed an Investigational New Drug
(IND) application with the U.S. Food and Drug Administration (FDA) and have initiated a Phase 1
clinical trial of a ZFP Therapeutic in patients with diabetic neuropathy during the first quarter
of 2005. Development of novel therapeutic products is costly and is subject to a lengthy and
uncertain regulatory process by the FDA. Our future products are gene-based therapeutics. Adverse
events in both our own clinical program and other programs in gene therapy may have a negative
impact on regulatory approval, the willingness of potential commercial partners to enter into
agreements and the perception of the public.
Research and development expenses consist
primarily of salaries and related personnel expenses, including stock-based compensation,
laboratory supplies, allocated facilities costs, subcontracted research expenses, trademark
registration and technology licenses. Research and development costs incurred in connection with
collaborator-funded activities are expensed as incurred. We believe that continued investment in
research and development is critical to attaining our strategic objectives. We expect these
expenses will increase significantly as we increase our focus on development of ZFP Therapeutics.
The Company is also developing ZFNs for therapeutic gene correction and therapeutic gene
modification as a treatment for certain monogenic and infectious diseases. Additionally, in order
to develop ZFP TFs and ZFNs as commercially relevant therapeutics, we expect to expend additional
resources for expertise in the manufacturing, regulatory affairs and clinical research aspects of
biotherapeutic development.
General and administrative expenses consist primarily of
salaries and related personnel expenses for executive, finance and administrative personnel,
stock-based compensation, professional fees, patent prosecution expenses, allocated facilities
costs and other general corporate expenses. As we pursue commercial development of our therapeutic
leads we expect the business aspects of the Company to become more complex. We may be required in
the future to add personnel and incur additional costs related to the maturity of our business.
Critical Accounting Estimates
The preparation of financial statements in conformity with
accounting principles generally accepted in the United States requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities and disclosure of
contingent assets and liabilities at the date of the financial statements and the reported amounts
of revenues and expenses during the reporting period. Such estimates are described in Note 1, Basis of
Presentation and Summary of Significant Accounting Policies to the Unaudited Notes to Condensed
Financial Statements. We base our estimates on historical experience and on various other
assumptions that we believe to be reasonable under the circumstances, the results of which form our
basis for making judgments about the carrying value of assets and liabilities that are not readily
apparent from other sources, and evaluates our estimates on an ongoing basis. Actual results could
differ from those estimates under different assumptions or conditions. Sangamo believes the
following critical accounting policies have significant effect in the preparation of our
consolidated financial statements.
Revenue Recognition
In accordance with Staff
Accounting Bulletin No. 104, Revenue Recognition, revenue from research activities made under
strategic partnering collaborations is recognized as the services are provided when there is persuasive
evidence that an arrangement exists, delivery has occurred, the price is fixed or determinable, and
collectibility is reasonably assured. Amounts received under such agreements are deferred until the
above criteria are met and the research services are performed. Sangamos federal government
research grants are typically multi-year agreements and provide for the reimbursement of qualified
expenses for research and development as defined under the terms of the grant agreement. Revenue
under grant agreements is recognized when the related research expenses are incurred. Grant
reimbursements are typically received on a quarterly basis and are subject to the issuing agencys
right of audit.
Sangamo recognizes revenue from its Therapeutic and Enabling Technology
collaborations when ZFP-based products are delivered to the collaborators, persuasive evidence of
an agreement exists, there are no unfulfilled obligations, the price is fixed and determinable, and
collectibility is reasonably assured. Generally, Sangamo receives partial payments from these
collaborations prior to the delivery of ZFP-based products and the recognition of these revenues is
deferred until the ZFP-based products are delivered, the
15
risk of ownership has passed to the
collaborator and all performance obligations have been satisfied. Upfront or signature payments
received upon the signing of an Enabling Technology agreement are generally recognized ratably over
the applicable period of the agreement, which currently ranges between 12 and 15 months, or as
ZFP-based products are delivered.
Milestone payments under research, partnering, or licensing
agreements are recognized as revenue upon the achievement of mutually agreed upon milestones,
provided that (i) the milestone event is substantive and its achievement is not reasonably assured
at the inception of the agreement, and (ii) there are no further significant performance
obligations associated with the milestone payment.
In accordance with Emerging Issues Task Force
Issue No. 00-21, Revenue Arrangements with Multiple Deliverables, revenue arrangements entered
into after June 15, 2003, that include multiple deliverables, are divided into separate units of
accounting if the deliverables meet certain criteria, including whether the fair value of the
delivered items can be determined and whether there is evidence of fair value of the undelivered
items. In addition, the consideration is allocated among the separate units of accounting based on
their fair values, and the applicable revenue recognition criterion is considered separately for
each of the separate units of accounting.
16
Stock-Based Compensation
Prior to January 1,
2006, we accounted for our stock-based employee compensation arrangements under the intrinsic value
method prescribed by Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to
Employees (APB No. 25), as allowed by SFAS No. 123, Accounting for Stock-based Compensation (SFAS
No. 123), as amended by SFAS No. 148, Accounting for Stock-Based Compensation Transition and
Disclosure (SFAS No. 148). As a result, no expense was recognized for options to purchase our
common stock that were granted with an exercise price equal to fair market value at the date of
grant and no expense was recognized in connection with purchases under our employee stock purchase
plan for the years ended December 31, 2005 or 2004. In December 2004, the Financial Accounting
Standards Board (FASB) issued SFAS No. 123 (revised 2004) Share-Based Payment (SFAS No. 123R),
which replaces SFAS No. 123 and supersedes APB No. 25. SFAS No. 123R requires all share-based
payments to employees, including grants of employee stock options, to be recognized in the
financial statements based on their fair values beginning with the first interim or annual period
after June 15, 2005. Subsequent to the effective date, the pro forma disclosures previously
permitted under SFAS No. 123 are no longer an alternative to financial statement recognition.
Effective January 1, 2006, we have adopted SFAS No. 123R using the modified prospective method.
Under this method, compensation cost recognized during the three-month and six-months period ended
June 30, 2006, includes: (a) compensation cost for all share-based payments granted prior to, but
not yet vested as of December 31, 2005, based on the grant date fair value estimated in accordance
with the original provisions of SFAS No. 123 amortized on an accelerated basis over the options
vesting period, and (b) compensation cost for all share-based payments granted subsequent to
December 31, 2005, based on the grant-date fair value estimated in accordance with the provisions
of SFAS No. 123R amortized on a straight-line basis over the options vesting period. Results for
prior periods have not been restated. As a result of adopting SFAS No. 123R on January 1, 2006, our
net loss is greater by $494,000 and $924,000 for the three-month and six month periods ended June
30, 2006, respectively, than had we continued to account for stock-based employee compensation
under APB No. 25. Net loss per share for the three-month and six month periods ended June 30, 2006
is $0.02 and $0.03 greater, respectively, than if we has continued to account for stock-based
compensation under APB No. 25. The adoption of SFAS No. 123R had no impact on cash flows from
operations or financing.
As of June 30, 2006, total compensation cost related to
nonvested stock options to be recognized in future periods was $3.47 million, which is expected to
be expensed over a weighted average period of 48 months.
RESULTS OF OPERATIONS
Three and six months ended June 30, 2006 and 2005
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
|
Six months ended June 30, |
|
|
|
(in thousands, except percentage values) |
|
|
(in thousands, except percentage values) |
|
|
|
2006 |
|
|
2005 |
|
|
Change |
|
|
% |
|
|
2006 |
|
|
2005 |
|
|
Change |
|
|
% |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration agreements |
|
$ |
1,431 |
|
|
$ |
353 |
|
|
$ |
1,078 |
|
|
|
305 |
% |
|
$ |
3,304 |
|
|
$ |
533 |
|
|
$ |
2,771 |
|
|
|
520 |
% |
Federal government research grants |
|
|
346 |
|
|
|
65 |
|
|
|
281 |
|
|
|
432 |
% |
|
|
609 |
|
|
|
141 |
|
|
|
468 |
|
|
|
332 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
1,777 |
|
|
$ |
418 |
|
|
$ |
1,359 |
|
|
|
325 |
% |
|
$ |
3,913 |
|
|
$ |
674 |
|
|
$ |
3,239 |
|
|
|
481 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
We are increasing the emphasis of our research and development activities on ZFP
Therapeutics and are moving away from our historic emphasis on Enabling Technology agreements. Over
the next several years, this change in resource allocation will reduce our revenues.
Total revenues increased to $1.8 million for the three months ended June 30, 2006 from
$418,000 in the corresponding period in 2005. The increase for the three months ended June 30, 2006
was principally due to revenues in connection with our Research License and Commercial Option
Agreement with Dow AgroSciences LLC (DAS), a wholly owned indirect subsidiary of Dow Chemical
Corporation, of $1.1 million, which we entered in October 2005. The increase in revenues related to
federal government research grants of $281,000 was due to increased revenues in connection with our
Advanced Technical Program federal government research grant with the National Institute of
Standards and Technologies of $180,000 and other federal government research grants of $100,000.
Total revenues increased to $3.3 million for the six months ended June 30, 2006 from $533,000 in
the corresponding period in 2005. The increase for the six months ended June 30, 2006 was
principally due to revenues in connection with our Research
17
License and Commercial Option Agreement
with DAS of $2.7 million. The increase in revenues related to federal government research grants
of $468,000 was due to increased revenues in connection with our Advanced Technical Program federal
government research grant with the National Institute of Standards and Technologies of $360,000 and
other federal government research grants of approximately $100,000. We anticipate continued
revenues from collaboration agreements through the end of 2007, and we have applied for, and plan
to continue to apply for, federal government research grants in the future to support the
development of applications of our technology platform. Although we have negotiated collaboration
agreements and received federal government research grants in the past, we cannot assure you that
these efforts will be successful in the future.
18
Operating Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
|
Six months ended June 30, |
|
|
|
(in thousands, except percentage values) |
|
|
(in thousands, except percentage values) |
|
|
|
2006 |
|
|
2005 |
|
|
Change |
|
|
% |
|
|
2006 |
|
|
2005 |
|
|
Change |
|
|
% |
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
4,028 |
|
|
$ |
2,624 |
|
|
$ |
1,404 |
|
|
|
54 |
% |
|
$ |
7,617 |
|
|
$ |
5,221 |
|
|
$ |
2,396 |
|
|
|
46 |
% |
General and administrative |
|
|
1,821 |
|
|
|
1,250 |
|
|
|
571 |
|
|
|
46 |
% |
|
|
3,576 |
|
|
|
2,489 |
|
|
|
1,087 |
|
|
|
44 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total expenses |
|
$ |
5,849 |
|
|
$ |
3,874 |
|
|
$ |
1,975 |
|
|
|
51 |
% |
|
$ |
11,193 |
|
|
$ |
7,710 |
|
|
$ |
3,483 |
|
|
|
45 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
Over the past three fiscal years, research and
development expenses have consisted primarily of salaries and related personnel expenses including
stock-based compensation as well as laboratory supplies, allocated facilities costs, subcontracted
research expenses, trademark registration and technology licenses. We expect to continue to devote
substantial resources to research and development in the future and expect research and development
expenses to increase in the next several years if we are successful in advancing our ZFP
Therapeutic product candidates into clinical trials. To the extent we collaborate with others with
respect to clinical trials, increases in research and development expenses may be reduced or
avoided.
Research and development expenses for the second quarter of 2006 increased to
$4.0 million compared to $2.6 million for the second quarter of 2005. The increase in research and
development expenses for the three months ended June 30, 2006 was primarily attributable to
increased external development expenses of $734,000, primarily associated with our diabetic
neuropathy program, increased personnel and lab supply expenses of $287,000 and $286,000,
respectively, due to increased headcount and recognition of $310,000 in stock-based employee
compensation expense due to adoption of SFAS No. 123R. These increases were partially offset by
decreased expenses of $108,000 associated with Pre-clinical efficacy expense as the company
completed the pre-clinical research during the second quarter of 2006, Research and development
expenses for the first six months of 2006 increased to $7.6 million compared to $5.2 million for
the corresponding period of 2005. The increase in research and development expenses for the six
months ended June 30, 2006 was primarily attributable to increased external development expenses of
$1.0 million primarily associated with our diabetic neuropathy program, increased personnel and lab
supply expenses of $515,000 and $444,000, respectively, due to increased headcount and recognition
of $627,000 in stock-based employee compensation expense due to adoption of SFAS No. 123R. These
increases were partially offset by decreased expenses of $100,000 facility overhead expense and
$25,000 associated with Pre-clinical efficacy expenses
General and administrative
General and administrative expenses consist primarily of salaries and related personnel expenses
for executive, finance and administrative personnel, stock-based compensation, professional fees,
patent prosecution expenses, allocated facilities costs, other general corporate expenses and
stock-based compensation. As we pursue commercial development of our therapeutic leads, we expect
the business aspects of the Company to become more complex. We may be required in the future to add
personnel and incur additional costs related to the maturity of our business.
General and
administrative expenses
were $1.8 million in the three months ended June 30, 2006, as compared to $1.3 million during the
corresponding period in 2005. This increase is primarily related to increased professional
service-related expenses of $322,000 and $184,000 related to recognition of stock-based employee
compensation expense due to adoption of SFAS No. 123R. General and administrative expenses were
$3.6 million in the six months ended June 30, 2006, as compared to $2.5 million during the
corresponding period in 2005. This increase is primarily related to increased professional
service-related expenses of $674,000 and $297,000 related to recognition of stock-based employee
compensation expense due to adoption of SFAS No. 123R.
Interest income, net
19
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
Six months ended June 30, |
|
|
(in thousands, except percentage values) |
|
(in thousands, except percentage values) |
|
|
2006 |
|
2005 |
|
Change |
|
% |
|
2006 |
|
2005 |
|
Change |
|
% |
Interest and other income, net |
|
$ |
745 |
|
|
$ |
76 |
|
|
$ |
669 |
|
|
|
880 |
% |
|
$ |
1,208 |
|
|
$ |
103 |
|
|
$ |
1,105 |
|
|
|
1,073 |
% |
Interest and other income, net, increased to $745,000 for the three months ended June 30, 2006
from $76,000 in the corresponding period in 2005. The increase was primarily related to higher
interest income of $391,000 related to higher average investment balances during the quarter ended
June 30, 2006. In addition, a foreign currency translation gain of $142,000 was recorded during the
quarter ended June 30, 2006 versus a foreign currency translation loss of $135,000 during the
corresponding quarter in 2005. Interest and other income, net, increased to $1.2 million for the
six months ended June 30, 2006 from $103,000 in the corresponding period in 2005. The increase was
primarily related to higher interest income of $634,000 related to higher average investment
balances during the six months ended June 30, 2006. In addition, a foreign currency translation
gain of $175,000 was recorded during the six months ended June 30, 2006 versus a foreign currency
translation loss of $221,000 during the corresponding quarter in 2005.
Liquidity and Capital Resources
Since inception, we have financed our operations primarily through the sale of
equity securities, payments from corporate collaborators, federal government research grants and
financing activities such as a bank line of credit. As of June 30, 2006, we had cash, cash
equivalents, investments and interest receivable totaling $59.3 million. Net cash used for
operating activities was $8.2 million for the six months ended June 30, 2006. Net cash used
consisted primarily of the net loss for the six-month period of $6.1 million and a net change of
$3.1 million in operating assets and liabilities. This was partially offset by stock-based
compensation charges of $950,000 and depreciation and amortization of $92,000. Net cash used for
operating activities was $7.3 million for the six months ended June 30, 2005. Net cash used
consisted primarily of the net loss for the three-month period of $6.9 million and a net change of
$976,000 in operating assets and liabilities. This was partially offset by amortization of premium
/ discount on investment of $191,000, stock-based compensation charges of $186,000, depreciation
and amortization of $149,000 and realized losses on investments of $41,000.
Net cash used in
investing activities was $1.9 million for the six months ended June 30, 2006 and was primarily
comprised of cash used to purchase investments and fixed assets of $16.0 million and $136,000,
respectively, partially offset by cash proceeds associated with maturities of investments of $14.2
million. Net cash provided by investing activities was $6.2 million for the six months ended June
30, 2005 and was primarily comprised of proceeds associated with maturities of investments and
fixed assets $15.2 million and $181,000, respectively, partially offset by cash used to purchase
investments of $8.9 million.
Net cash provided by financing activities for the six-month period
ended June 30, 2006 was $20.5 million. In June 2006, in an underwritten public offering and
pursuant to an effective registration statement, we sold 3,100,000 shares of common stock at a
public offering price of $6.75 per share, resulting in net proceeds of approximately $20.15 million
after deducting underwriters discount. All other cash provided by financing activities for the
first six months of 2006 and 2005 was solely related to proceeds from issuance of common stock
related to stock options exercises.
While we expect our rate of cash usage to increase in the
future, in particular, in support of our product development endeavors, we believe that the
available cash resources, funds received from corporate collaborators, strategic partners and
federal government research grants will be sufficient to finance our operations through 2008. We
may need to raise additional capital to fund our ZFP Therapeutic development activities. Additional
capital may not be available in terms acceptable to us, or at all. If adequate funds are not
available, our business and our ability to develop our technology and our ZFP Therapeutic products
would be harmed.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our
exposure to market risk for changes in interest rates relates primarily to our cash equivalents and
investments. The investments are available-for-sale. We do not use derivative financial instruments
in our investment portfolio. We attempt to ensure the safety and preservation of our invested funds
by limiting default and market risks. Our cash and investments policy emphasizes liquidity and
preservation of principal over other portfolio considerations. We select investments that maximize
interest income to the extent possible within these guidelines. We satisfy liquidity requirements
by investing excess cash in securities with different maturities to match projected cash needs and
limit concentration of credit risk by diversifying our investments among a variety of high
credit-quality issuers. We mitigate default risk by investing in only investment-grade securities.
The portfolio includes marketable securities with active secondary or resale markets to ensure
portfolio liquidity. All investments have a fixed interest rate and are carried at market value,
which approximates cost.
20
Our market risks at June 30, 2006
have not changed materially from those discussed in Item 7A of our Form 10-K for the year ended
December 31, 2005 on file with the Securities and Exchange Commission.
ITEM 4. CONTROLS AND PROCEDURES
(a) Evaluation of Disclosure Controls and Procedures
The Companys management, with
the participation of the Companys Chief Executive Officer and Principal Financial Officer,
evaluated the effectiveness of the Companys disclosure controls and procedures (as defined in
Exchange Act Rule 13a-15(e) or 15d-15(e)) as of the end of the period covered by this report. Based
on that evaluation, the Chief Executive Officer and Principal Financial Officer concluded that the
Companys disclosure controls and procedures as of the end of the period covered by this report are
functioning effectively to provide reasonable assurance that the information required to be
disclosed by the Company in reports filed under the Securities Exchange Act of 1934 is recorded,
processed, summarized and reported within the time periods specified in the SECs rules and forms.
(b) Change in Internal Control over Financial Reporting
No change in the Companys internal
control over financial reporting occurred during the Companys most recent fiscal quarter that has
materially affected, or is reasonably likely to materially affect, the Companys internal control
over financial reporting.
21
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
We are not party
to any material pending legal proceedings, other than routine litigation incidental to our
business.
ITEM 1A. RISKS FACTORS
This Form 10-Q contains forward-looking information based on
our current expectations. Because our actual results may differ materially from any forward-looking
statements made by or on behalf of Sangamo, this section includes a discussion of important factors
that could affect our actual future results, including, but not limited to, our revenues, expenses,
net loss and loss per share.
We have increased the focus of our research and development programs
on human therapeutics, which may increase operating expenditures and the uncertainty of our
business. We are increasing the emphasis and focus of our research and development activities on
ZFP Therapeutics and have relatively fewer resources invested in our Enabling Technology programs.
In the short term, this change in resource allocation may reduce our revenues and increase
operating expenditures due to larger financial outlays to fund preclinical studies, manufacturing,
and clinical research. The transition will also increase the visibility of our lead therapeutic
programs and the potential impact on the stock price of news releases relating to these programs.
We, and our partner, Edwards Lifesciences, have initiated Phase 1 clinical trials in our respective
lead ZFP Therapeutic programs, and ZFP Therapeutics have never before been tested in humans. We
have completed enrollment and treatment of the patients in the first of these trials of SB-509 for
diabetic neuropathy and thus far have not observed any drug-related adverse events. However if our
lead ZFP Therapeutic fails its initial safety study, it could reduce our ability to attract new
investors and corporate partners. In January 2005, Sangamo filed an IND with the FDA for SB-509, a
ZFP TF activator of VEGF-A, for the treatment of mild to moderate diabetic neuropathy. We have
completed enrollment and treatment of a Phase 1, single blind, dose-escalation trial to measure the
laboratory and clinical safety of SB-509 and reported that we did not observe dose-limiting
toxicity or any severe adverse drug-related events. We presented in April 2006 safety data and
preliminary findings from our Phase 1 clinical trial and expect to initiate a Phase 2 clinical
trial of SB-509 in the second half of 2006. Edwards Lifesciences also filed an investigational new
drug (IND) application with the U.S. Food and Drug Administration (FDA) on February 10, 2004 and
initiated a Phase 1 clinical trial in humans in August, 2004 and a second in the first half of
2005. The first Phase 1 studies of a ZFP Therapeutic will be a highly visible test of the Companys
ZFP Therapeutic approach. Since we have increased our focus on ZFP Therapeutic research and
development, investors will increasingly assess the value of the Companys technology based on the
continued progress of ZFP Therapeutic products into and through clinical trials. If the initial
safety study of our lead therapeutic was halted due to safety concerns, this would negatively
affect the value of the Companys stock.
We are conducting proprietary research to discover ZFP
Therapeutic product candidates. These programs increase our financial risk of product failure, will
significantly increase our research expenditures, and may involve conflicts with our collaborators
and strategic partners. Our proprietary research programs consist of research which is funded
solely by the Company and where the Company retains exclusive rights to therapeutic products
generated by the research. This is in contrast to certain of our research programs that may be
funded by corporate partners and in which we may share rights to any resulting products. We have
conducted proprietary research since inception, however, we are placing greater emphasis on
proprietary research and therapeutic development and we expect this trend will continue in 2006 as
we initiate our first Phase 2 clinical trial and bring new ZFP Therapeutics into clinical trials.
Conducting proprietary research programs may not generate corresponding revenue and may create
conflicts with our collaborators or strategic partners. The implementation of this strategy will
involve substantially greater business risks, the expenditure of significantly greater funds than
our historic research activities and will require substantial commitments of time from our
management and staff.
In addition, disagreements with our collaborators or strategic partners
could develop over rights to our intellectual property with respect to our proprietary research
activities. Any conflict with our collaborators or strategic partners could reduce our ability to
enter into future collaboration or strategic partnering agreements and negatively impact our
relationship with existing collaborators and strategic partners, which could reduce our revenue and
delay or terminate our product development.
If conflicts arise between us and our collaborators,
strategic partners, scientific advisors, or directors, these parties may act in their
self-interest, which may limit our ability to implement our strategies. If conflicts arise between
our corporate or academic collaborators, strategic partners, or scientific advisors or directors
and us, the other party may act in its self-interest, which may limit our ability to implement our
strategies. Our license agreement with Edwards Lifesciences provides Edwards with worldwide,
22
exclusive rights for ZFP Therapeutics for the activation of VEGF and VEGF receptors for the
treatment and prevention of ischemic cardiovascular and vascular disease in humans. We have
retained all rights to use our technology for all therapeutic applications of VEGF activation
outside of the treatment and prevention of ischemic cardiovascular and vascular disease in humans.
During the first quarter of 2005, Sangamo commenced a Phase 1 clinical trial for the treatment of diabetic
neuropathy using a ZFP Therapeutic for the activation of VEGF. Edwards has stated that its rights
include diabetic neuropathy and consequently our activities relating to diabetic neuropathy
constitute a breach of the agreement. We strongly disagree with the Edwards assertion because
diabetic neuropathy is a neurological disease and not an ischemic vascular disease and therefore is
outside the scope of the Edwards license. Sangamo and Edwards are in discussions regarding this
issue. Some of our academic collaborators and strategic partners are conducting multiple product
development efforts within each area that is the subject of the collaboration with us. Our
collaborators or strategic partners, however, may develop, either alone or with others, products in
related fields that are competitive with the products or potential products that are the subject of
these collaborations. Competing products, either developed by the collaborators or strategic
partners or to which the collaborators or strategic partners have rights, may result in the
withdrawal of partner support for our product candidates.
Some of our collaborators or strategic
partners could also become competitors in the future. Our collaborators or strategic partners could
develop competing products, preclude us from entering into collaborations with their competitors,
fail to obtain timely regulatory approvals, terminate their agreements with us prematurely, or fail
to devote sufficient resources to the development and commercialization of products. Any of these
developments could harm our product development efforts.
Our collaborators may control aspects of
our clinical trials, which could result in delays and other obstacles in the commercialization of
our proposed products. For some programs we are dependent on third party collaborators to design
and conduct our clinical trials. As a result, we may not be able to conduct these programs in the
manner or on the time schedule we currently contemplate. In addition, if any of these collaborative
partners withdraw support for our programs or proposed products or otherwise impair their
development, our business could be negatively affected.
We have limited experience in conducting
clinical trials, and we may encounter unanticipated toxicity or adverse events or fail to
demonstrate the efficacy, causing us to delay, suspend or terminate the development of our ZFP
Therapeutics. Our ZFP Therapeutics may fail to show the desired safety and efficacy in initial
clinical trials. Even if we successfully complete Phase 1 trials, the FDA will require additional
Phase 2 and Phase 3 clinical testing which involves significantly greater resources, commitments
and expertise that may require us to enter into a collaborative relationship with a pharmaceutical
company that would assume responsibility for late-stage development and commercialization.
Our
potential therapeutic products are subject to a lengthy and uncertain regulatory process, and we
may encounter unanticipated toxicity or adverse events or fail to demonstrate efficacy, causing us
to delay, suspend or terminate the development of a ZFP
Therapeutics and if these potential
products are not approved, we will not be able to commercialize those products. The FDA must
approve any human therapeutic products before they can be marketed in the United States. The
process for receiving regulatory approval is long and uncertain, and a potential product may not
withstand the rigors of testing under the regulatory approval processes.
Before commencing
clinical trials in humans, we or our commercial partner must submit an Investigational New Drug
(IND) application to the FDA. The FDA has 30 days to comment on the IND. If the FDA does not
comment on the IND, we or our commercial partner may begin clinical trials.
Clinical trials are
subject to oversight by institutional review boards and the FDA. In addition, our proposed clinical
studies will require review from the Recombinant DNA Advisory Committee, or RAC, which is the
advisory board to the National Institutes of Health, or NIH, focusing on clinical trials involving
gene transfer. We will typically submit a proposed clinical protocol and other product-related
information to the RAC three to six months prior to the expected IND filing date.
Clinical trials:
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must be conducted in conformance with the FDAs good clinical practices ICH guidelines and
other applicable regulations; |
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must meet requirements for institutional review board oversight; |
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must follow Institutional Biosafety Committee (IBC) and NIH RAC guidelines where applicable; |
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must meet requirements for informed consent; |
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are subject to continuing FDA oversight; |
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may require large numbers of test subjects; and |
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may be suspended by our commercial partner, the FDA, or us at any time if it is believed that the subjects participating in these trials are being
exposed to unacceptable health risks or if the FDA finds deficiencies in the IND or the conduct of
these trials. |
Clinical trials are lengthy and are typically conducted in three sequential phases,
but the phases may overlap or be combined. Each trial must be reviewed and approved by an
independent ethics committee or institutional review board before it can begin. Phase 1 usually
involves the initial introduction of the investigational drug into healthy volunteers or patients
to evaluate certain factors, including its safety, dosage tolerance and, if possible, to gain an
early indication of its effectiveness. Phase 2 usually involves trials in a limited patient
population to evaluate dosage tolerance and appropriate dosage, identify possible adverse effects
and safety risks, and evaluate preliminarily the efficacy of the drug for specific indications.
Phase 3 trials usually further evaluate clinical efficacy and test further for safety by using the
drug in its final form in an expanded patient population. Later clinical trials may fail to support
the findings of earlier trials, which would delay, limit or prevent regulatory approvals.
While we
have stated our intention to file an additional IND applications during the next several years,
this is only a statement of intent, and we may not be able to do so because the associated product
candidates may not meet the necessary preclinical requirements. In addition, there can be no
assurance that, once filed, an IND application will result in the actual initiation of clinical
trials.
We may not be able to find acceptable patients or may experience delays in enrolling
patients for our clinical trials. The FDA or we may suspend our clinical trials at any time if
either believes that we are exposing the subjects participating in these trials to unacceptable
health risks. The FDA or institutional review boards and/or institutional biosafety committees at
the medical institutions and healthcare facilities where we sponsor clinical trials may suspend any
trial indefinitely if they find deficiencies in the conduct of these trials. The FDA and
institutional review boards may also require large numbers of patients, and the FDA may require
that we repeat a clinical trial.
The results of early Phase 1 trials are based on a small number
of patients over a short period of time, and our success may not be indicative of results in a
large number of patients or of long-term efficacy. The results in early phases of clinical testing are
based upon limited numbers of patients and a limited follow-up period. For example, the initial
results from the Phase 1 clinical trial of our ZFP Therapeutic, SB-509 product, we presented in
April 2006. The primary end point of the trial is clinical and laboratory safety, however we also
collected some preliminary efficacy data. Typically, our Phase 1 clinical trials for indications of
safety enroll less than 50 patients. We anticipate that our Phase 2 clinical trials for efficacy
would typically enroll approximately 100 patients. Actual results with more data points may not
confirm favorable results from our earlier stage trials. A number of companies in the
pharmaceutical and biotechnology industries have suffered significant setbacks in late stage
clinical trials even after achieving promising results in earlier stage clinical trials. In
addition, we do not yet know if early results will have a lasting effect. If a larger population of
patients does not experience positive results, or if these results do not have a lasting effect,
our products may not receive approval from the FDA. Failure to demonstrate the safety and
effectiveness of our gene based products in larger patient populations could have a material
adverse effect on our business that would cause our stock price to decline significantly.
We
cannot predict whether or when we will obtain regulatory approval to commercialize our product
candidates, therefore we cannot predict the timing of any future revenue from these product
candidates. We cannot commercialize any of our product candidates to generate revenue until the
appropriate regulatory authorities have reviewed and approved the applications for the product
candidates. We cannot assure you that the regulatory agencies will complete their review processes
in a timely manner or that we will obtain regulatory approval for any product candidate that we, or
our collaborators, develop. Satisfaction of regulatory requirements typically takes many years, is
dependent upon the type, complexity and novelty of the product and requires the expenditure of
substantial resources. Regulatory approval processes outside the United States include all of the
risks associated with the FDA approval process. In addition, we may experience delays or rejections
based upon additional government regulation from future legislation or administrative action or
changes in FDA policy during the period of product development, clinical trials and FDA regulatory
review.
Our gene regulation and gene modification technology is relatively new, and if we are
unable to use this technology in all our intended applications, it would limit our revenue
opportunities. Our technology involves a relatively new approach to gene regulation and gene
modification. Although we have generated ZFP TFs for hundreds of gene sequences, we have not
created ZFP TFs for all gene sequences and may not be able do so, which could limit the usefulness
of our technology. In addition, while we have
24
demonstrated the function of engineered ZFP TFs in
mammalian cell culture, yeast, insects, plants, and animals, we have not yet done so in humans, and
the failure to do so could restrict our ability to develop commercially viable products. If we, and
our collaborators or strategic partners, are unable to extend our results to new commercially
important genes, experimental animal models, and human clinical studies, we may be unable to use
our technology in all its intended applications. Also, delivery of ZFP TFs and ZFNs into cells and
organisms, including humans, in these and other environments is limited by a number of technical
hurdles, which we may be unable to surmount. This is a particular challenge for therapeutic
applications of our technology that will require the use of gene transfer systems that may not be
effective for the delivery of our ZFP TFs or ZFNs in a particular therapeutic application.
The
expected value and utility of our ZFP TFs and ZFNs is in part based on our belief that the targeted
or specific regulation of gene expression and targeted gene modification may enable us to develop a
new therapeutic approach as well as to help scientists better understand the role of human, animal,
and other genes in disease and to aid their efforts in drug discovery and development. We also
believe that the regulation of gene expression and targeted gene insertion will have utility in
agricultural applications. There is only a limited understanding of the role of specific genes in
all these fields. Life sciences companies have developed or commercialized only a few products in
any of these fields based on results from genomic research or the ability to regulate gene
expression. We, our collaborators, or our strategic partners may not be able to use our technology
to identify and validate drug targets or to develop commercial products in the intended markets.
We are currently engaged in the research and development of a new application of our technology
platform: ZFP-mediated gene modification using ZFNs to effect either gene correction or gene
disruption. Using this technique, Sangamo scientists have engineered ZFNs to cut DNA at a specific
site within a target gene, and to then to either correct the adjacent sequences with newly
synthesized DNA copied from an introduced DNA template, gene correction, or to rejoin the two ends
of the break which frequently results in the disruption of the genes function. In so doing, we are
attempting to correct an abnormal or disease-related mutation or DNA sequence or to disrupt a
gene that is involved in disease pathology. ZFP-mediated gene modification is at an early research
stage. Our scientists have shown ZFP-mediated gene modification to work in isolated cells; however,
a significant amount of additional research will be needed before this technique can be evaluated
in animals or plants and subsequently tested for applications in human healthcare and plant
agriculture.
We may be unable to license gene transfer technologies that we may need to
commercialize our ZFP TF technology. In order to regulate a gene in a cell, the ZFP TF or ZFN must
be efficiently delivered to the cell. We have licensed certain gene transfer technologies for use
with our Enabling Technologies, which are ZFP TFs and ZFNs used in pharmaceutical discovery
research and protein production. We are evaluating these systems and other technologies, which may
need to be used in the delivery of ZFP TFs or ZFNs into cells for in vitro and in vivo
applications, including ZFP Therapeutics. However, we may not be able to license the gene transfer
technologies required to develop and commercialize our ZFP Therapeutics. We have not developed our
own gene transfer technologies, and we rely on our ability to enter into license agreements to
provide us with rights to the necessary gene transfer technology. The inability to obtain a license
to use gene transfer technologies with entities which own such technology on reasonable commercial
terms, if at all, could delay or prevent the preclinical evaluation, clinical testing, and/or
commercialization of our therapeutic product candidates.
We do not currently have the
infrastructure or capability to manufacture therapeutic products on a
commercial scale. In order for us to commercialize these products directly, we would need to
develop, or obtain through outsourcing arrangements, the capability to execute all of these
functions. If we are unable to develop or otherwise obtain the requisite preclinical, clinical,
regulatory, manufacturing, marketing, and sales capabilities, we would be unable to directly
commercialize our therapeutics products which would limit our future growth.
Even if our
technology proves to be effective, it still may not lead to commercially viable products. Even if
our collaborators or strategic partners are successful in using our ZFP technology in drug
discovery, protein production, therapeutic development, or plant agriculture, they may not be able
to commercialize the resulting products or may decide to use other methods competitive with our
technology. To date, no company has received marketing approval or has developed or commercialized
any therapeutic or agricultural products based on our technology. The failure of our technology to
provide safe, effective, useful, or commercially viable approaches to the discovery and development
of these products would significantly limit our business and future growth and would adversely
affect our value.
Even if our product development efforts are successful and even if the requisite
regulatory approvals are obtained, our ZFP Therapeutics may not gain market acceptance among
physicians, patients, healthcare payers and the medical community. A number of additional factors
may limit the market acceptance of products including the following:
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likelihood and rate of adoption by healthcare practitioners; |
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likelihood and rate of a products acceptance by the
target population; |
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timing of market entry relative to competitive products; |
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availability of
alternative therapies; |
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price of our product relative to alternative therapies; |
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availability
of third-party reimbursement; |
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extent of marketing efforts by us and third-party distributors or
agents retained by us; and |
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side effects or unfavorable publicity concerning our products or
similar products. |
Adverse events in the field of gene therapy may negatively impact regulatory
approval or public perception of our potential products. Our potential therapeutic products are
delivered to patients as gene-based drugs, or gene therapy. The clinical and commercial success of
our potential products will depend in part on public acceptance of the use of gene therapy for the
prevention or treatment of human diseases. Public attitudes may be influenced by claims that gene
therapy is unsafe, and, consequently, our products may not gain the acceptance of the public or the
medical community. Negative public reaction to gene therapy in general could result in greater
government regulation and stricter labeling requirements of gene therapy products, including any of
our products, and could cause a decrease in the demand for any products we may develop.
Our stock
price is also influenced by public perception. Reports of serious adverse events in a retroviral
gene transfer trial for infants with X-linked severe combined immunodeficiency (X-linked SCID) in
France and subsequent FDA actions putting related trials on hold in the United States had a
significant negative impact on the public perception and stock price of certain companies involved
in gene therapy. Stock prices of these companies declined whether or not the specific company was
involved with retroviral gene transfer for the treatment of infants with SCID, or whether the
specific companys clinical trials were placed on hold in connection with these events.
Other
potential adverse events in the field of gene therapy may occur in the future that could result in
greater governmental regulation of our potential products and potential regulatory delays relating
to the testing or approval of our potential products.
We are at the development phase of
operations and may not succeed or become profitable. We began operations in 1995 and are in the
early phases of ZFP Therapeutic product development. We have incurred significant losses and our
net losses to date and our revenues have been generated from Enabling Technology collaborations,
strategic partners, and federal government research grants. In 2005, we have placed more emphasis
on higher-value therapeutic product development and related strategic partnerships. This shift in
emphasis has the potential to increase the return on investment to our stockholders by allocating
capital resources to higher value, therapeutic product development activities. At the same time, it
increases our financial risk by increasing expenses associated with product development. In
addition, the preclinical or clinical failure of any single product may have a significant effect
on the actual or perceived value of our shares. Our business is subject to all of the risks
inherent in the development of a new technology, which include the need to:
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attract and retain
qualified scientific and technical staff and management, particularly scientific staff with
expertise to develop our early-stage technology into therapeutic products; |
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obtain sufficient
capital to support the expense of developing our technology platform and developing, testing, and
commercializing products; |
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develop a market for our products; |
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successfully transition from a
company with a research focus to a company capable of supporting commercial activities; and |
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attract and enter into research collaborations with research and academic institutions and
scientists. |
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Commercialization of our technologies will depend, in part, on strategic partnering
with other companies. If we are not able to find strategic partners in the future or our strategic
partners do not diligently pursue product development efforts, we may not be able to develop our
technologies or products, which could slow our growth and decrease our value. We expect to rely, to
some extent, on our strategic partners to provide funding in support of our research and to perform
independent research and preclinical and clinical testing. Our technology is broad based, and we do
not currently possess the resources necessary to fully develop and commercialize potential products
that may result from our technologies or the resources or capabilities to complete the lengthy
marketing approval processes that may be required for the products. Therefore, we plan to rely on
strategic partnerships to help us develop and commercialize ZFP Therapeutic products. If those
partners are unable or unwilling to advance our programs, or if they do not diligently pursue
product approval, this may slow our progress and defer our revenues. Our partners may sublicense or
abandon development programs or we may have disagreements with our partners, which would cause
associated product development to slow or cease. There can be no assurance that we will be able to
establish additional strategic collaborations for ZFP Therapeutic product development. We may
require significant time to secure additional collaborations or strategic partners because we need
to effectively market the benefits of our technology to these future collaborators and strategic
partners, which use the time and efforts of research and development personnel and our
management. Further, each collaboration or strategic partnering arrangement will involve the
negotiation of terms that may be unique to each collaborator or strategic partner. These business
development efforts may not result in a collaboration or strategic partnership.
The loss of our
current or any future strategic partnering agreements would not only delay or terminate the
potential development or commercialization of products we may derive from our technologies, but it
may also delay or terminate our ability to test ZFP TFs for specific genes. If any strategic
partner fails to conduct the collaborative activities successfully and in a timely manner, the
preclinical or clinical development or commercialization of the affected product candidates or
research programs could be delayed or terminated.
Our existing strategic partnering agreements are
based on the achievement of milestones. Under the strategic partnering agreements, we expect to
receive revenue for the research and development of a ZFP Therapeutic product and based on
achievement of specific milestones. Achieving these milestones will depend, in part, on the efforts
of our strategic partner as well as our own. In contrast, our historic Enabling Technology
collaborations only pay us to supply ZFP TFs for the collaborators independent use, rather than
for future results of the collaborators efforts. If we, or any strategic partner, fail to meet
specific milestones, then the strategic partnership may be terminated, which could decrease our
revenues.
If our competitors develop, acquire, or market technologies or products that are more
effective than ours, this would reduce or eliminate our commercial opportunity. Any products that
we or our collaborators or strategic partners develop by using our ZFP technology platform will
enter into highly competitive markets. Even if we are able to generate ZFP Therapeutics that are
safe and effective for their intended use, competing technologies may prove to be more effective or
less expensive, which, to the extent these competing technologies achieve market acceptance, will
limit our revenue opportunities. In some cases, competing technologies have proven to be
satisfactorily effective and less expensive, as has been the case with technologies competitive
with our Enabling Technology(R). The effectiveness of these competing products has reduced the
revenues generated by our Enabling Technology. Competing technologies may include other methods of
regulating gene expression or modifying genes. ZFP TFs and ZFNs have broad application in the life
sciences and compete with a broad array of new technologies and approaches being applied to genetic
research by many companies. Competing proprietary technologies with our product development focus
include:
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small molecule drugs; |
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monoclonal antibodies; |
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recombinant proteins; |
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gene therapy / cDNAs; |
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antisense; and |
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siRNA approaches |
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For our
Enabling Technology Applications: |
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For protein production: gene amplification, meganucleases,
insulator technology; |
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For target validation: antisense, siRNA; and |
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For plant agriculture:
recombination approaches, mutagenesis approaches, meganucleases; |
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In addition to possessing
competing technologies, our competitors include biotechnology companies with: |
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substantially greater capital resources than ours; |
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larger research and development
staffs and facilities than ours; and |
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greater experience in product development and in
obtaining regulatory approvals and patent protection; |
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These organizations also compete
with us to: |
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attract qualified personnel; |
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attract parties for acquisitions, joint ventures or other collaborations; and |
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license the proprietary
technologies of academic and research institutions that are competitive with our technology, which
may preclude us from pursuing similar opportunities. |
Accordingly, our competitors may
succeed in obtaining patent protection or commercializing products before us. In addition, any
products that we develop may compete with existing products or services that are well established
in the marketplace.
Our collaborators or strategic partners may decide to adopt
alternative technologies or may be unable to develop commercially viable products with our
technology, which would negatively impact our revenues and our strategy to develop these products.
Our collaborators or strategic partners may adopt alternative technologies, which could decrease
the marketability of ZFP technology. Additionally, because many of our collaborators or strategic
partners are likely to be working on more than one development project, they could choose to shift
their resources to projects other than those they are working on with us. If they do so, that would
delay our ability to test our technology and would delay or terminate the development of potential
products based on our ZFP technology. Further, our collaborators and strategic partners may elect
not to develop products arising out of our collaborative and strategic partnering arrangements or
to devote sufficient resources to the development, manufacturing, marketing, or sale of these
products. If any of these events occur, we may not be able to develop our technologies or
commercialize our products.
We anticipate continuing to incur operating losses for the
next several years. If material losses continue for a significant period, we may be unable to
continue our operations. We have generated operating losses since we began operations in 1995. The
extent of our future losses and the timing of profitability are uncertain, and we expect to incur
losses for the foreseeable future. We have been engaged in developing our ZFP TF technology since
inception, which has and will continue to require significant research and development
expenditures. In November 2005, we announced that we had completed a registered direct offering to
institutional and strategic investors for a total of 5,080,000 shares of common stock at a price of
$3.85 per share to the investors, resulting in net proceeds to Sangamo of approximately $18.2
million. In June 2006, in an underwritten public offering and pursuant to an effective registration
statement, we sold 3,100,000 shares of common stock at a public offering price of $6.75 per share,
resulting in net proceeds of approximately $20.15 million after deducting underwriters discount.
To date, we have generated all other revenue from Enabling Technology collaborations, strategic
partnering agreements, and federal government research grants. As of June 30, 2006, we had an
accumulated deficit of approximately $116.5 million. We expect to incur losses for the foreseeable
future. These losses will increase as we expand and extend our research and development activities
into human therapeutic product development. If the time required to generate significant product
revenues and achieve profitability is longer than we currently anticipate, we may not be able to
sustain our operations.
We may be unable to raise additional capital, which would harm
our ability to develop our technology and products. We have incurred significant operating losses
and negative operating cash flows since inception and have not achieved profitability. We
expect capital outlays and operating expenditures to increase over the next several years as we
expand our infrastructure and research and ZFP Therapeutic product development activities. While we
believe our financial resources will be adequate to sustain our current operations at least through
2007, we may seek additional sources of capital through equity or debt financing. In addition, as
we focus our efforts on proprietary human therapeutics, we will need to seek FDA approval of
potential products, a process that could cost in excess of $100 million per product. We cannot be
certain that we will be able to obtain financing on terms acceptable to us, or at all. If
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adequate
funds are not available, our business and our ability to develop our technology and ZFP Therapeutic
products would be harmed.
Our stock price has been volatile and may continue to be volatile, which
could result in substantial losses for investors. During the quarter ended June 30, 2006, our stock
price ranged from a low of $4.10 to high of $7.73. During the past two years, our common stock
price has fluctuated significantly, ranging from a low of $3.46 to a high of $7.73 during the year
ended December 31, 2005, and a low of $3.00 to a high of $8.02 during the year ended December 31,
2004. Volatility in our common stock could cause stockholders to incur substantial losses. An
active public market for our common stock may not be sustained, and the market price of our common
stock may continue to be highly volatile. The market price of our common stock has fluctuated
significantly in response to the following factors, some of which are beyond our control:
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announcements by us or our partners providing updates on the progress or development status of ZFP
Therapeutics; |
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changes in market valuations of similar companies; |
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deviations in our results
of operations from the guidance given by us or estimates of securities analysts; |
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announcements
by us or our competitors of new or enhanced products, technologies or services or significant
contracts, acquisitions, strategic relationships, joint ventures or capital commitments; |
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regulatory developments; |
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additions or departures of key personnel; |
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future sales of our
common stock or other securities by the company, management or directors, liquidation of
institutional funds that comprised large holdings of Sangamo stock; |
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decreases in our cash
balances; and |
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general stock market trends. |
Our common stock is thinly traded, which means
large transactions in our common stock may be difficult to conduct in a short time frame. We have a
low volume of daily trades in our common stock on the Nasdaq National Market. For example, the
average daily trading volume in our common stock on the Nasdaq National Market over the ten-day
trading period prior to August 1, 2006 was approximately 133,000 shares per day. Any large
transactions in our common stock may be difficult to conduct and may cause significant fluctuations
in the price of our common stock.
Failure to attract, retain, and motivate skilled personnel and
cultivate key academic collaborations will delay our product development programs and our research
and development efforts. We are a small company with 68 full-time employees as of May 8, 2006 and
our success depends on our continued ability to attract, retain, and motivate highly qualified
management and scientific personnel and our ability to develop and maintain important relationships
with leading research and academic institutions and scientists. Competition for personnel and
academic and other research collaborations is intense. The success of our technology development
programs depends on our ability to attract and retain highly trained personnel and we have
experienced a rate of employee turnover that we believe is typical of emerging biotechnology
companies. If we lose the services of personnel with the necessary skills, it could significantly
impede the achievement of our research and development objectives. We are not presently aware of
any plans of specific employees to retire or otherwise leave the company. If we fail to negotiate
additional acceptable collaborations with academic and other research institutions and scientists,
or if our existing collaborations are unsuccessful, our ZFP Therapeutic development programs may be
delayed or may not succeed.
Because it is difficult and costly to protect our proprietary rights,
and third parties have filed patent applications that are similar to ours, we cannot ensure the
proprietary protection of our technologies and products. Our commercial success will depend in part
on obtaining patent protection of our technology and successfully defending any of our patents
which may be challenged. The patent positions of pharmaceutical and biotechnology companies can be
highly uncertain and can involve complex legal and factual questions. No consistent policy
regarding the breadth of claims allowed in biotechnology patents has emerged to date. Accordingly,
we cannot predict the breadth of claims allowed in patents we own or license.
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We are a party to
various license agreements that give us rights under specified patents and patent applications. Our
current licenses, as our future licenses frequently will, contain performance obligations. If we
fail to meet those obligations, the licenses could be terminated. If we are unable to continue to
license these technologies on commercially reasonable terms, or at all, we may be forced to delay
or terminate our product development and research activities.
With respect to our present and any
future sublicenses, since our rights derive from those granted to our sublicensor, we are subject
to the risk that our sublicensor may fail to perform its obligations under the master license or
fail to inform us of useful improvements in, or additions to, the underlying intellectual property
owned by the original licensor.
We are unable to exercise the same degree of control over
intellectual property that we license from third parties as we exercise over our internally
developed intellectual property. We do not control the prosecution of certain of the patent
applications that we license from third parties; therefore, the patent applications may not be
prosecuted exactly as we desire or in a timely manner.
The degree of future protection for our
proprietary rights is uncertain, and we cannot ensure that:
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we or our licensors were the first
to make the inventions covered by each of our pending patent applications; |
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we or our licensors
were the first to file patent applications for these inventions; |
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the patents of others will not
have an adverse effect on our ability to do business; |
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others will not independently develop
similar or alternative technologies or reverse engineer any of our products, processes or
technologies; |
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any of our pending patent applications will result in issued patents; |
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any
patents issued or licensed to us or our collaborators or strategic partners will provide a basis
for commercially viable products or will provide us with any competitive advantages; |
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any
patents issued or licensed to us will not be challenged and invalidated by third parties; or |
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we
will develop
additional products, processes or technologies that are patentable. |
Others have filed and in the
future are likely to file patent applications that are similar to ours. We are aware that there are
academic groups and other companies that are attempting to develop technology that is based on the
use of zinc finger and other DNA binding proteins, and that these groups and companies have filed
patent applications. Several patents have been issued, although we have no current plans to use the
associated inventions. If these or other patents issue, it is possible that the holder of any
patent or patents granted on these applications may bring an infringement action against our
collaborators, strategic partners, or us claiming damages and seeking to enjoin commercial
activities relating to the affected products and processes. The costs of litigating the claim could
be substantial. Moreover, we cannot predict whether we, our collaborators, or strategic partners
would prevail in any actions. In addition, if the relevant patent claims were upheld as valid and
enforceable and our products or processes were found to infringe the patent or patents, we could be
prevented from making, using, or selling the relevant product or process unless we could obtain a
license or were able to design around the patent claims. We can give no assurance that such a
license would be available on commercially reasonable terms, or at all, or that we would be able to
successfully design around the relevant patent claims. There may be significant litigation in the
genomics industry regarding patent and other intellectual property rights, which could subject us
to litigation. If we become involved in litigation, it could consume a substantial portion of our
managerial and financial resources.
We cannot guarantee that third parties will not challenge our
intellectual property. One of our licensed patents, European Patent No. 0 682 699, entitled
Functional Domains in Flavobacterium Okeanokoites Restriction Endonuclease was granted on May 7,
2003 and forms the basis of Regional Phase patents in France, Germany, Great Britain, Ireland and
Switzerland. The granted claims of the patent cover technologies used in our programs in targeted
recombination and gene correction. On December 1, 2005 an interlocutory decision revoking this
patent was issued by the European Patent Office. We have appealed this decision. If our appeal is
ultimately unsuccessful, our ability to exclude potential competitors in the field of targeted
recombination and gene correction in Europe may be limited. These developments apply only to Europe
and do not affect our ability to practice our targeted recombination and gene correction programs
in Europe. Moreover, we also hold licenses to six US patents to the technology covered by the
opposed European patent, and hold licenses to related applications pending in Canada and Japan.
Accordingly, any effects of the opposition, up to and
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including invalidation of the European
patent, would be restricted to Europe and would have little, if any, material adverse effect on our
business.
We rely on trade secrets to protect technology where we believe patent protection is not
appropriate or obtainable. Trade secrets, however, are difficult to protect. While we require
employees, academic collaborators, and consultants to enter into confidentiality agreements, we may
not be able to adequately protect our trade secrets or other proprietary information or enforce
these confidentiality agreements.
Our collaborators, strategic partners, and scientific advisors
have rights to publish data and information in which we may have rights. If we cannot maintain the
confidentiality of our technology and other confidential information in connection with our
collaborations and strategic partnerships, then we may not be able to receive patent protection or
protect our proprietary information.
Regulatory approval, if granted, may be limited to specific
uses or geographic areas, which could limit our ability to generate revenues. Regulatory approval
will be limited to the indicated use for which we can market a product. Further, once regulatory
approval for a product is obtained, the product and its manufacturer are subject to continual
review. Discovery of previously unknown problems with a product or manufacturer may result in
restrictions on the product, manufacturer, and manufacturing facility, including withdrawal of the
product from the market. In Japan and Europe, regulatory agencies also set or approve prices.
Even if regulatory clearance of a product is granted, this clearance is limited to those
specific states and conditions for which the product is useful, as demonstrated through clinical
trials. We cannot ensure that any ZFP Therapeutic product developed by us, alone or with others,
will prove to be safe and effective in clinical trials and will meet all of the applicable
regulatory requirements needed to receive marketing clearance in a given country.
Outside
the United States, our ability to market a product is contingent upon receiving a marketing
authorization from the appropriate regulatory authorities, so we cannot predict whether or when we
would be permitted to commercialize our product. These foreign regulatory approval processes
include all of the risks associated with FDA clearance described above.
Our
collaborations with outside scientists may be subject to change, which could limit our access to
their expertise. We work with scientific advisors and collaborators at academic research
institutions. These scientists are not our employees and may have other commitments that would
limit their availability to us. Although our scientific advisors generally agree not to do
competing work, if a conflict of interest between their work for us and their work for another
entity arises, we may lose their services. Although our scientific advisors and academic
collaborators sign agreements not to disclose our confidential information, it is possible that
some of our valuable proprietary knowledge may become publicly known through them.
Laws
or public sentiment may limit the production of genetically modified agricultural products in the
future, and these laws could reduce our partners ability to sell these products. Genetically
modified products are currently subject to public debate and heightened regulatory scrutiny, either
of which could prevent or delay production of agricultural products. Effective as of October 1,
2005, we entered into a Research License and Commercial Option Agreement with Dow AgroSciences LLC
(DAS), a wholly owned indirect subsidiary of Dow Chemical Corporation. Under this agreement, we
will provide DAS with access to our proprietary ZFP technology and the exclusive right to use our
ZFP technology to modify the genomes or alter the nucleic acid or protein expression of plant
cells, plants, or plant cell cultures. The field-testing, production, and marketing of genetically
modified plants and plant products are subject to federal, state, local, and foreign governmental
regulation. Regulatory agencies administering existing or future regulations or legislation may not
allow production and marketing of our genetically modified products in a timely manner or under
technically or commercially feasible conditions. In addition, regulatory action or private
litigation could result in expenses,
delays, or other impediments to our product development programs or the commercialization of
resulting products.
The FDA currently applies the same regulatory standards to foods
developed through genetic engineering as those applied to foods developed through traditional plant
breeding. Genetically engineered food products, however, will be subject to pre-market review if
these products raise safety questions or are deemed to be food additives. Governmental authorities
could also, for social or other purposes, limit the use of genetically modified products created
with our gene regulation technology.
Even if we are able to obtain regulatory approval
for genetically modified products, our success will also depend on public acceptance of the use of
genetically modified products including drugs, plants, and plant products. Claims that genetically
modified products are unsafe for consumption or pose a danger to the environment may influence
public attitudes. Our genetically modified products may not gain public acceptance. The subject of
genetically modified organisms has received negative publicity in the United States and
particularly in Europe, and such publicity has aroused public debate. The adverse publicity in
Europe could lead to greater regulation and trade restrictions on imports of genetically altered
products. Similar adverse public reaction in the United States to genetic
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research and its
resulting products could result in greater domestic regulation and could decrease the demand for
our technology and products.
If we use biological and hazardous materials in a manner that causes
injury or violates laws, we may be liable for damages. Our research and development activities
involve the controlled use of potentially harmful biological materials as well as hazardous
materials, chemicals, and various radioactive compounds typically employed in molecular and
cellular biology. We routinely use cells in culture and gene delivery vectors, and we employ small
amounts of radioisotopes in trace experiments. Although we maintain up-to-date licensing and
training programs, we cannot completely eliminate the risk of accidental contamination or injury
from the use, storage, handling, or disposal of these materials. In the event of contamination or
injury, we could be held liable for damages that result, and any liability could exceed our
resources. We currently carry insurance covering claims arising from our use of these materials.
However, if we are unable to maintain our insurance coverage at a reasonable cost and with adequate
coverage, our insurance may not cover any liability that may arise. We are subject to federal,
state, and local laws and regulations governing the use, storage, handling, and disposal of these
materials and specified waste products. To date, we have not experienced significant costs in
complying with regulations regarding the use of these materials.
Anti-takeover provisions in our
certificate of incorporation and Delaware law could make an acquisition of the Company more
difficult and could prevent attempts by our stockholders to remove or replace current management.
Anti-takeover provisions of Delaware law, our certificate of incorporation and our bylaws and may
discourage, delay or prevent a change in control of our company, even if a change in control would
be beneficial to our stockholders. In addition, these provisions may frustrate or prevent any
attempts by our stockholders to replace or remove our current management by making it more
difficult for stockholders to replace members of our board of directors. In particular, under our
certificate of incorporation our board of directors may issue up to 5,000,000 shares of preferred
stock with rights and privileges that might be senior to our common stock, without the consent of
the holders of the common stock. Moreover, without any further vote or action on the part of the
stockholders, the board of directors would have the authority to determine the price, rights,
preferences, privileges, and restrictions of the preferred stock. This preferred stock, if it is
ever issued, may have preference over, and harm the rights of, the holders of common stock.
Although the issuance of this preferred stock would provide us with flexibility in connection with
possible acquisitions and other corporate purposes, this issuance may make it more difficult for a
third party to acquire a majority of our outstanding voting stock. Similarly, our authorized but
unissued common stock is available for future issuance without stockholder approval.
In addition,
our certificate of incorporation:
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states that stockholders may not act by written consent but
only at a stockholders meeting; |
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establishes advance notice requirements for nominations for
election to the board of directors or proposing matters that can be acted upon at stockholders
meetings; and |
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limits who may call a special meeting of stockholders. |
We are also subject to
Section 203 of the Delaware General Corporation Law, which provides, subject to certain exceptions,
that if a person acquires 15% of our voting stock, the person is an interested stockholder and
may not engage in business combinations with us for a period of three years from the time the
person acquired 15% or more or our voting stock.
Insiders have substantial control over Sangamo
and could delay or prevent a change in corporate control. The interest of management could conflict
with the interest of our other stockholders. Our executive officers and directors beneficially own,
in the aggregate, approximately 18% of our outstanding common stock. As a result, these
stockholders, if they choose to act together, will be able to have a material impact on all matters
requiring stockholder approval, including the election of directors and approval of significant
corporate transactions. This could have the effect of delaying or preventing a change of control of
Sangamo, which in turn could reduce the market price of our stock.
Accounting pronouncements may
affect our future financial position and results of operations On January 1, 2006, we adopted
Statement of Financial Accounting Standards No. 123 (revised 2004), Share-Based Payment (or FAS
123R). As a result, we have included employee stock-based compensation costs in our results of
operations for the quarter and six months ended June 30, 2006, as discussed in Note 2, Employee
Stock-Based Compensation, in the Notes to Condensed Consolidated Financial Statements of Part I,
Item I of this Form 10-Q. Our adoption of FAS 123R is expected to result in compensation expense
that will increase basic and diluted net loss per share by approximately $0.08 per share for 2006.
However, our estimate of future employee stock-based compensation expense is affected by our stock
price, the number of stock-based awards our board of directors may grant in 2006, as well as a
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number of complex and subjective valuation assumptions. These valuation assumptions include, but
are not limited to, the volatility of our stock price and employee stock option exercise behaviors.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
The effective date of our
first Registration Statement on Form S-1 filed under the Securities Act of 1933, as amended,
relating to the initial public offering of our common stock was April 6, 2000. On the same date, we signed an underwriting
agreement with Lehman Brothers, Chase H&Q, ING Barings LLC, and William Blair & Co., the managing
underwriters for the initial public offering and the representatives of the underwriters named in
the underwriting agreement, for the initial public offering of 3,500,000 shares of our common stock
at an initial public offering price of $15 per share. The offering commenced on April 6, 2000 and
was closed on April 11, 2000. The initial public offering resulted in gross proceeds of $52.5
million. We received net proceeds of $48.8 million after deducting underwriting discounts of $3.7
million. Expenses related to the offering totaled approximately $1.4 million. None of Sangamos net
proceeds from the initial public offering were paid directly or indirectly to any director,
officer, general partner of Sangamo or their associates, persons owning 10% or more of any class of
equity securities of Sangamo, or an affiliate.
In November 2005, we completed a registered direct
offering to institutional and strategic investors for a total of 5,080,000 shares of common stock
at a price of $3.85 per share to the investors, resulting in net proceeds to Sangamo of
approximately $18.2 million.
In June 2006, in an underwritten public offering and pursuant to an
effective registration statement, we sold 3,100,000 shares of common stock at a public offering
price of $6.75 per share, resulting in net proceeds of approximately $20.15 million after deducting
underwriters discount.
From the time of receipt through June 30, 2006, Sangamo has used the net
proceeds from its initial public offering, registered direct offering and underwritten public
offering of common stock to invest in short-term and long-term, interest bearing, investment-grade
securities and has used its existing cash balances to fund general operations. The proceeds are
being used for general corporate purposes, including working capital and product development. A
portion of the net proceeds will also be used to acquire or invest in complementary businesses or
products or to obtain the right to use complementary technologies. Sangamo has no agreements or
commitments with respect to any such acquisition and is not currently engaged in any material
negotiations with respect to any such transaction.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
The annual meeting of shareholders was held on June 7, 2006. Two matters were
voted on and each was approved. The results are as follows:
PROPOSAL I
The following directors
were elected at the meeting to serve until our annual meeting following the end of fiscal year 2006
or until their successors are duly elected and qualified:
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NOMINEE |
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VOTES FOR |
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VOTES WITHHELD |
Edward O. Lanphier, II |
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27,350,816 |
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110,133 |
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William G. Gerber, M.D. |
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27,397,785 |
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63,164 |
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John W. Larson |
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25,317,245 |
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2,143,704 |
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Margaret A. Liu, M.D. |
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27,396,935 |
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64,014 |
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Steven J. Mento, Ph.D. |
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27,391,485 |
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69,464 |
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H. Ward Wolff |
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27,398,935 |
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62,014 |
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Michael C. Wood |
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27,198,067 |
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262,882 |
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PROPOSAL II
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The proposal to ratify the selection of Ernst & Young LLP as the Companys independent
registered public accounting firm for the fiscal year ending December 31, 2006 was approved.
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FOR |
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AGAINST |
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ABSTAINED |
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NON VOTES |
27,331,648 |
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90,083 |
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39,218 |
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0 |
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ITEM 6. EXHIBITS
(a) Exhibits:
31.1 |
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Form of Rule 13a 14(a) Certification |
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31.2 |
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Form of Rule 13a 14(a) Certification |
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32.1 |
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Certification Pursuant to 18 U.S.C. Section 1350. |
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SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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SANGAMO BIOSCIENCES, INC. Dated: August 4, 2006
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/s/ Greg S. Zante |
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Greg S. Zante |
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Senior Director, Finance and Administration |
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(Principal Financial and Accounting Officer) |
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