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 September 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 November 1, 2006, 33,939,552 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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September 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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$ |
16,117 |
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$ |
18,507 |
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Marketable securities |
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40,763 |
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28,449 |
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Interest receivable |
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110 |
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218 |
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Accounts receivable |
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273 |
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971 |
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Prepaid expenses |
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504 |
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317 |
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Total current assets |
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57,767 |
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48,462 |
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Property and equipment, net |
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483 |
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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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$ |
58,299 |
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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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$ |
1,156 |
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$ |
1,534 |
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Accrued compensation and employee benefits |
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835 |
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933 |
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Deferred revenue |
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2,873 |
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4,327 |
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Total current liabilities |
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4,864 |
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6,794 |
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Deferred revenue, non-current portion |
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2,500 |
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4,375 |
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Total liabilities |
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7,364 |
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11,169 |
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Stockholders equity: |
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Common stock, $0.01 par value; 80,000,000
shares authorized, 33,938,913 and 30,570,912
shares issued and outstanding at September
30, 2006 and December 31, 2005, respectively |
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34 |
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31 |
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Additional paid-in capital |
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170,118 |
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148,131 |
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Accumulated deficit |
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(119,324 |
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(110,408 |
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Accumulated other comprehensive income |
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107 |
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60 |
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Total stockholders equity |
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50,935 |
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37,814 |
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Total liabilities and stockholders equity |
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$ |
58,299 |
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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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Nine months ended |
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September 30, |
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September 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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$ |
357 |
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$ |
4,735 |
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$ |
890 |
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Federal government research grants |
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348 |
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55 |
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957 |
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197 |
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Total revenues |
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1,779 |
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412 |
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5,692 |
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1,087 |
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Operating expenses: |
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Research and development |
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3,853 |
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2,988 |
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11,470 |
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8,210 |
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General and administrative |
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1,569 |
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1,216 |
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5,145 |
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3,705 |
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Total operating expenses |
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5,422 |
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4,204 |
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16,615 |
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11,915 |
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Loss from operations |
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(3,643 |
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(3,792 |
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(10,923 |
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(10,828 |
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Interest and other income, net |
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798 |
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125 |
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2,007 |
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228 |
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Net loss |
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$ |
(2,845 |
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$ |
(3,667 |
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$ |
(8,916 |
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$ |
(10,600 |
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Basic and diluted net loss per share |
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$ |
(0.08 |
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$ |
(0.14 |
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$ |
(0.28 |
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$ |
(0.42 |
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Shares used in computing basic and diluted net loss per share |
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33,939 |
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25,430 |
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31,960 |
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25,386 |
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See accompanying notes.
4
SANGAMO BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
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Nine months ended |
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September 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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$ |
(8,916 |
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$ |
(10,600 |
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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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126 |
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215 |
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Amortization of (premium) / discount on investments |
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(399 |
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201 |
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Realized loss on investments |
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47 |
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41 |
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Stock-based compensation |
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1,519 |
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290 |
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Changes in operating assets and liabilities: |
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Interest receivable |
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108 |
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161 |
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Accounts receivable |
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698 |
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478 |
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Prepaid expenses and other assets |
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(187 |
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(218 |
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Accounts payable and accrued liabilities |
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(378 |
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1 |
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Accrued compensation and employee benefits |
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(98 |
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(9 |
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Deferred revenue |
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(3,329 |
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(135 |
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Net cash used in operating activities |
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(10,809 |
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(9,575 |
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Investing Activities: |
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Purchases of investments |
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(39,643 |
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(12,080 |
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Maturities of investments |
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27,728 |
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23,446 |
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Purchases of property and equipment |
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(137 |
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(207 |
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Net cash (used in) / provided by investing activities |
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(12,052 |
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11,159 |
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Financing Activities: |
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Proceeds from issuance of common stock |
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20,471 |
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317 |
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Net cash provided by financing activities |
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20,471 |
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317 |
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Net (decrease) / increase in cash and cash equivalents |
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(2,390 |
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1,901 |
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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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$ |
16,117 |
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$ |
10,527 |
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See accompanying notes.
5
SANGAMO BIOSCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited) September 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. (we, 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 nine months ended September 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 $ 565,000 and $1.5
million for the three-month period and nine-month period ended September 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 nine-month period ended
September 30, 2006 are $0.02 and $0.05 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 repurchases 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 September 30, 2006, total shares reserved for future awards under all plans were 8,338,121.
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 nine-month periods ended September 30, 2006 (in thousands):
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Three months ended |
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Nine months ended |
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September 30, 2006 |
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September 30, 2006 |
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Costs and expenses: |
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Research and development |
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$ |
247 |
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$ |
874 |
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General and administrative |
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318 |
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615 |
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Total stock-based compensation expense |
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$ |
565 |
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$ |
1,489 |
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There was no capitalized stock-based employee compensation cost as of September 30, 2006. There
were no recognized tax benefits during the nine months ended September 30, 2006.
As of September 30, 2006, total compensation cost related to nonvested stock options to be
recognized in future periods was $2.86 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 nine-month period ended September 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 |
|
|
Nine months ended |
|
|
|
September 30, 2005(1) |
|
|
September 30, 2005(1) |
|
Net loss, as reported |
|
$ |
(3,667 |
) |
|
$ |
(10,600 |
) |
Deduct: Total stock-based employee
compensation expense determined
under fair value method |
|
|
(620 |
) |
|
|
(1,834 |
) |
|
|
|
|
|
|
|
Pro forma net loss |
|
$ |
(4,287 |
) |
|
$ |
(12,434 |
) |
|
|
|
|
|
|
|
Basic and diluted net loss per share: |
|
|
|
|
|
|
|
|
As reported |
|
$ |
(0.14 |
) |
|
$ |
(0.42 |
) |
|
|
|
|
|
|
|
Pro forma |
|
$ |
(0.17 |
) |
|
$ |
(0.49 |
) |
|
|
|
|
|
|
|
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 $527,000 or $0.02
per basic and diluted share for three-months period ended September 30, 2005 and $1,264,000 or
$0.05 per basic and diluted share for nine-months period ended September 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 |
|
Nine months ended |
|
|
September 30, |
|
September 30, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
Risk-free interest rate |
|
|
4.8 |
% |
|
|
4.5 |
% |
|
|
4.8-5.1 |
% |
|
|
3.7-4.5 |
% |
Expected life of option |
|
6.25 years |
|
5.0 years |
|
6.25 years |
|
5.0 years |
Expected dividend yield of stock |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
Expected volatility |
|
|
0.95 |
|
|
|
1.00 |
|
|
|
0.91-0.97 |
|
|
|
1.10 |
|
The weightedaverage assumptions used for estimating the fair value of the employees purchase
rights are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Nine months ended |
|
|
September 30, |
|
September 30, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
Risk-free interest rate |
|
|
5.1-5.2 |
% |
|
|
1.3-3.6 |
% |
|
|
4.8-5.2 |
% |
|
|
1.3-3.6 |
% |
Expected life of option |
|
0.5-2 years |
|
0.5-2 yrs |
|
0.5-2 yrs |
|
0.5-2 yrs |
Expected dividend yield of stock |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
Expected volatility |
|
|
0.50-0.98 |
|
|
|
0.52-0.78 |
|
|
|
0.41-0.98 |
|
|
|
0.52-0.78 |
|
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 |
|
|
(181,000 |
) |
|
|
181,000 |
|
|
$ |
6.49 |
|
|
|
|
|
Options exercised |
|
|
|
|
|
|
(223,442 |
) |
|
$ |
1.57 |
|
|
|
|
|
Options canceled |
|
|
228,814 |
|
|
|
(228,814 |
) |
|
$ |
7.45 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2006 |
|
|
3,304,319 |
|
|
|
3,602,841 |
|
|
$ |
5.46 |
|
|
|
6.17 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at September 30, 2006 |
|
|
|
|
|
|
2,328,264 |
|
|
$ |
5.90 |
|
|
|
4.93 |
|
There were no shares subject to Sangamos right of repurchase as of September 30, 2006. The
intrinsic value of options exercised were $400 and $83,000 for the three months ended September 30,
2006 and 2005 and $1,063,000 and $512,000 for the nine months ended September 30, 2006 and 2005,
respectively.
The weighted-average estimated fair value per share of options granted during the three months and
nine months ended September 30, 2006 and 2005 were $3.81 and $3.65, and $5.23 and $3.15,
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 nine months ended September 30, 2006 and 2005 were $1.11 and $1.63,and $1.66 and $1.67,
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 September
30, 2006:
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding |
|
|
|
|
|
|
Weighted Average |
|
|
|
|
|
|
Remaining |
Range of Exercise Price |
|
Number of Shares |
|
Contractual Life |
|
|
|
|
|
|
(In Years) |
$0.05 - $0.15 |
|
|
61,583 |
|
|
|
1.37 |
|
$0.17 - $0.17 |
|
|
400,000 |
|
|
|
1.60 |
|
$0.23 - $3.61 |
|
|
433,758 |
|
|
|
7.01 |
|
$3.78 - $4.08 |
|
|
298,126 |
|
|
|
7.23 |
|
$4.11 - $4.11 |
|
|
390,000 |
|
|
|
9.20 |
|
$4.15 - $5.18 |
|
|
254,657 |
|
|
|
7.69 |
|
$5.19 - $5.19 |
|
|
487,267 |
|
|
|
7.55 |
|
$5.30 - $7.13 |
|
|
252,750 |
|
|
|
7.21 |
|
$7.49 - $7.49 |
|
|
415,000 |
|
|
|
4.99 |
|
$7.57 - $38.00 |
|
|
609,700 |
|
|
|
5.22 |
|
|
|
|
|
|
|
|
|
|
|
|
|
3,602,841 |
|
|
|
6.17 |
|
|
|
|
|
|
|
|
|
|
At September 30, 2006, the aggregate intrinsic values of the outstanding and exercisable options
were $4.3 million and $3.2 million, respectively.
Sangamo granted 10,000 nonqualified common stock options to consultants during the three
months and nine months ended September 30, 2006. The Company did not grant any stock option to
consultants during three-months ended September 30, 2005 and granted 15,000 nonqualified stock
options for the nine months ended September 2005. 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 $4,000 and $107,000 for the three months
period ended September 30, 2006 and 2005 and $30,000 and $290,000 for the nine months period ended
September 30, 2006 and 2005, respectively. The fair value of these options was determined using the
Black-Scholes Merton model.
10
RECENT ACCOUNTING PRONOUNCEMENT
In September 2006 the FASB issued FASB Statement No. 157, Fair Value Measurements, or SFAS 157.
The standard provides guidance for using fair value to measure assets and liabilities. The
standard also responds to investors requests for expanded information about the extent to which
companies measure assets and liabilities at fair value, the information used to measure fair value,
and the effect of fair value measurements on earnings. The standard applies whenever other
standards require or permit assets or liabilities to be measured at fair value. The standard does
not expand the use of fair value in any new circumstances. SFAS 157 must be adopted prospectively
as of the beginning of the year it is initially applied. SFAS 157 is effective for financial
statements issued for fiscal years beginning after November 15, 2007, and interim periods within
those fiscal years. We are still evaluating what impact, if any; the adoption of this standard
will have on our financial position or results of operations.
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 income (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 |
|
|
Nine months ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Net loss |
|
$ |
(2,845 |
) |
|
$ |
(3,667 |
) |
|
$ |
(8,916 |
) |
|
$ |
(10,600 |
) |
Changes in unrealized gain on securities available-for-sale |
|
|
76 |
|
|
|
|
|
|
|
47 |
|
|
|
63 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(2,769 |
) |
|
$ |
(3,667 |
) |
|
$ |
(8,869 |
) |
|
$ |
(10,537 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
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 disease. 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 $2.0 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 nine-month periods ended September 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
11
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.
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 September 30, 2006 and 2005, revenues attributable to collaborative
research and development performed under the LifeScan agreements were $150,000 and $105,000,
respectively. Revenues for the nine-month periods ended September 30, 2006 and 2005 were $450,000
and $215,000, respectively. Related research and development costs and expenses performed under the
LifeScan agreements were $64,000 and $9,000 during the three months ended September 30, 2006 and
2005, respectively. Research and development costs and expenses performed under the LifeScan
agreements were $96,000 and $46,000 during the nine months ended September 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 $156,000 and $252,000 during the three months ended
September 30, 2006 and 2005, respectively. Revenues for the nine-month periods ended September 30,
2006 and 2005 were $463,000 and $675,000, respectively. Related research and development costs and
expenses performed under the Pfizer agreement were $87,000 and $53,000 during the three months
ended September 30, 2006 and 2005, respectively, and $242,000 and $105,000 during the nine months
ended September 30, 2006 and 2005, respectively.
12
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 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 September 30, 2006
and $1.9 million during the nine months ended September 30, 2006. Revenues attributable to
collaborative research and development performed under the DAS agreement were $500,000 during the
three months ended September 30, 2006 and $1.9 million during the nine months ended September 30,
2006. Related costs and expenses incurred under the DAS agreement were $500,000 during the three
months ended September 30, 2006 and $1.9 million during the nine months ended September 30, 2006.
13
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.
NOTE 6-SUBSEQUENT EVENT
On October 26, 2006, Sangamo announced a partnership with the Juvenile Diabetes Research
Foundation (JDRF) to provide financial support of Sangamos upcoming Phase 2 human clinical studies
of SB-509, a ZFP Therapeutic that is in development for the treatment of diabetic neuropathy.
Under the agreement with JDRF and subject to its terms and conditions, including the Companys
achievement of certain milestones associated with the Companys Phase 2 clinical trial of SB-509
for the treatment of diabetic neuropathy, JDRF will pay the Company an aggregate amount up to $3.0
million. Sangamo is obligated to cover all costs of the Phase 2 trial that are not covered by
JDRFs grant.
14
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 September 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 September 30, 2006, we had an accumulated deficit of
$119.3 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 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.
15
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 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.
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
16
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
nine-months period ended September 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 $565,000 and $1.5 million for the
three-month and nine month periods ended September 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 nine month periods ended September 30, 2006 is $0.02 and $0.05 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 September 30, 2006, total compensation cost related to nonvested stock options to be
recognized in future periods was $2.86 million, which is expected to be expensed over a weighted
average period of 48 months.
RESULTS OF OPERATIONS
Three and nine months ended September 30, 2006 and 2005
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended September 30, |
|
|
Nine months ended September 30, |
|
|
|
(in thousands, except percentage values) |
|
|
(in thousands, except percentage values) |
|
|
|
2006 |
|
|
2005 |
|
|
Change |
|
|
% |
|
|
2006 |
|
|
2005 |
|
|
Change |
|
|
% |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration agreements |
|
$ |
1,431 |
|
|
$ |
357 |
|
|
$ |
1,074 |
|
|
|
301 |
% |
|
$ |
4,735 |
|
|
$ |
890 |
|
|
$ |
3,845 |
|
|
|
432 |
% |
Federal government research grants |
|
|
348 |
|
|
|
55 |
|
|
|
293 |
|
|
|
533 |
% |
|
|
957 |
|
|
|
197 |
|
|
|
760 |
|
|
|
385 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
1,779 |
|
|
$ |
412 |
|
|
$ |
1,367 |
|
|
|
332 |
% |
|
$ |
5,692 |
|
|
$ |
1,087 |
|
|
$ |
4,605 |
|
|
|
424 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 September 30, 2006 from
$412,000 in the corresponding period in 2005. The increase for the three months ended September 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 $293,000 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 $230,000 and other federal government research grants of $55,000.
Total revenues increased to $5.7 million for the nine months ended September 30, 2006 from $1.1
million in the corresponding period in 2005. The increase for the nine months ended September 30,
2006 was principally due to revenues in connection with our Research License and Commercial Option
Agreement with DAS of $3.8 million. The increase in revenues related to federal government
research grants of $760,000 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 $615,000 and other federal government research grants of approximately $169,000. 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.
17
Operating Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended September 30, |
|
|
Nine months ended September 30, |
|
|
|
(in thousands, except percentage values) |
|
|
(in thousands, except percentage values) |
|
|
|
2006 |
|
|
2005 |
|
|
Change |
|
|
% |
|
|
2006 |
|
|
2005 |
|
|
Change |
|
|
% |
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
3,853 |
|
|
$ |
2,988 |
|
|
$ |
865 |
|
|
|
29 |
% |
|
$ |
11,470 |
|
|
$ |
8,210 |
|
|
$ |
3,260 |
|
|
|
40 |
% |
General and administrative |
|
|
1,569 |
|
|
|
1,216 |
|
|
|
353 |
|
|
|
29 |
% |
|
|
5,145 |
|
|
|
3,705 |
|
|
|
1,440 |
|
|
|
39 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total expenses |
|
$ |
5,422 |
|
|
$ |
4,204 |
|
|
$ |
1,218 |
|
|
|
29 |
% |
|
$ |
16,615 |
|
|
$ |
11,915 |
|
|
$ |
4,700 |
|
|
|
39 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 third quarter of 2006 increased to $3.9 million
compared to $3.0 million for the third quarter of 2005. The increase in research and development
expenses for the three months ended September 30, 2006 was primarily attributable to increased
personnel and lab supply expenses of $342,000 and $301,000, respectively, due to increased
headcount, recognition of $247,000 in stock-based employee compensation expense due to adoption of
SFAS No. 123R and increased consulting expenses of $158,000 in support of our diabetic neuropathy
program. These increases were partially offset by decreased manufacturing expenses of $223,000
associated with our diabetic neuropathy program. Research and development expenses for the first
nine months of 2006 increased to $11.5 million compared to $8.2 million for the corresponding
period of 2005. The increase in research and development expenses for the nine months ended
September 30, 2006 was primarily attributable to recognition of $874,000 in stock-based employee
compensation expense due to adoption of SFAS No. 123R, increased personnel and lab supply expenses
of $858,000 and $741,000, respectively, due to increased headcount, increased consulting expenses
of $434,000 in support of our diabetic neuropathy program and increased manufacturing expenses of
$367,000 associated with our diabetic neuropathy program.
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 $1.6 million in the three months ended September 30,
2006, as compared to $1.2 million during the corresponding period in 2005. This increase is
primarily related to recognition of $318,000 in stock-based employee compensation expense due to
adoption of SFAS No. 123R. General and administrative expenses were $5.1 million in the nine months
ended September 30, 2006, as compared to $3.7 million during the corresponding period in 2005. This
increase is primarily related to increased professional service-related expenses of $684,000 and
$615,000 related to recognition of stock-based employee compensation expense due to adoption of
SFAS No. 123R.
Interest income, net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended September 30, |
|
|
Nine months ended September 30, |
|
|
|
(in thousands, except percentage values) |
|
|
(in thousands, except percentage values) |
|
|
|
2006 |
|
|
2005 |
|
|
Change |
|
|
% |
|
|
2006 |
|
|
2005 |
|
|
Change |
|
|
% |
|
Interest and other income, net |
|
$ |
798 |
|
|
$ |
125 |
|
|
$ |
673 |
|
|
|
538 |
% |
|
$ |
2,007 |
|
|
$ |
228 |
|
|
$ |
1,779 |
|
|
|
780 |
% |
18
Interest and other income, net, increased to $798,000 for the three months ended September 30,
2006 from $125,000 in the corresponding period in 2005. The increase was primarily related to
higher interest income of $521,000 related to higher average investment balances during the quarter
ended September 30, 2006 from the June 2006 equity financing. In addition, a foreign currency
translation gain of $111,000 was recorded during the quarter ended September 30, 2006 versus a
foreign currency translation loss of $76,000 during the corresponding quarter in 2005. Interest
and other income, net, increased to $2.0 million for the nine
months ended September 30, 2006 from $228,000 in the corresponding period in 2005. The
increase was primarily related to higher interest income of $1.2 million related to higher average
investment balances during the nine months ended September 30, 2006 from the June 2006 equity
financing. In addition, a foreign currency translation gain of $287,000 was recorded during the
nine months ended September 30, 2006 versus a foreign currency translation loss of $297,000 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 September 30, 2006, we had cash, cash equivalents,
investments and interest receivable totaling $57.0 million. Net cash used for operating activities
was $10.8 million for the nine months ended September 30, 2006. Net cash used consisted primarily
of the net loss for the nine-month period of $8.9 million, a net change of $3.2 million in
operating assets and liabilities and amortization of premium / discount on investments of $399,000.
This was partially offset by stock-based compensation charges of $1.5 million and depreciation and
amortization of $126,000. Net cash used for operating activities was $9.6 million for the nine
months ended September 30, 2005. Net cash used consisted primarily of the net loss for the nine
month period of $10.6 million. This was partially offset by stock-based compensation charges of
$290,000, a net change of $278,000 in operating assets and liabilities, depreciation and
amortization of $215,000 and amortization of premium / discount on investments of $201,000.
Net cash used in investing activities was $12.1 million for the nine months ended September
30, 2006 and was primarily comprised of cash used to purchase investments and fixed assets of $39.6
million and $137,000, respectively, partially offset by cash proceeds associated with maturities of
investments of $27.7 million. Net cash provided by investing activities was $11.2 million for the
nine months ended September 30, 2005 and was primarily comprised of proceeds associated with
maturities of investments of $23.4 million, partially offset by cash used to purchase investments
and fixed assets of $12.1 million and 207,000, respectively.
Net cash provided by financing activities for the nine-month period ended September 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 nine 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.
Our market risks at September 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.
19
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, and that such information is accumulated and communicated
to management, including our Chief Executive Officer and Principal Financial Officer, or persons
performing similar functions, as appropriate to allow timely decisions regarding required
disclosure.
(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.
20
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 investigational new drug (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 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.
21
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, 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 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 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, were 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.
23
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 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
24
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 September 30, 2006, we had an accumulated deficit of approximately $119.3
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 2008, 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 adequate funds are not available, our business
and our ability to develop our technology and ZFP Therapeutic products would be harmed.
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Our stock price has been volatile and may continue to be volatile, which could result in
substantial losses for investors. During the three months ended September 30, 2006, our stock price
ranged from a low of $4.38 to high of $6.12. During the nine months ended September 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 November 1, 2006 was
approximately 124,000 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 71 full-time employees as of October 31, 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 including invalidation of the European patent, would be restricted to Europe and would have
little, if any, material adverse effect on our business.
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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 research and its resulting products could result in greater domestic regulation and could
decrease the demand for our technology and products.
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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 nine months ended September 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 greater losses that increases 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 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.
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ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
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 September 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.
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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.
SANGAMO BIOSCIENCES, INC. Dated: November 7, 2006
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/s/ Greg S. Zante
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Greg S. Zante |
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Vice President, Finance and Administration
(Principal Financial and Accounting Officer) |
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