Viracta Therapeutics, Inc. - Quarter Report: 2006 September (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM 10-Q
(Mark
One)
ý |
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
o |
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 000-51531
SUNESIS
PHARMACEUTICALS, INC.
(Exact
name of Registrant as specified in its Charter)
Delaware
|
94-3295878
|
|
(State
or Other Jurisdiction of Incorporation or Organization)
|
(I.R.S.
Employer Identification Number)
|
341
Oyster Point Boulevard
South
San Francisco, California 94080
(Address
of Principal Executive Offices including Zip Code)
(650)
266-3500
(Registrant’s
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 Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the
registrant was required to file reports), and (2) has been subject to such
filing requirements for the past 90 days. YES x
NO
o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer (as defined in Rule 12b-2 of
the Exchange Act).
Large
Accelerated Filer o
Accelerated Filer o
Non-Accelerated Filer x
Indicate
by check mark whether the registrant is a shell company (as defined in
Rule 12b-2 of the Securities Exchange Act). YES o
NO
x
The
Registrant had 29,362,640 shares of Common Stock, $0.0001 par value per share,
outstanding as of October 31, 2006.
Sunesis
Pharmaceuticals, Inc.
TABLE
OF CONTENTS
Page
No.
|
||
PART I.
FINANCIAL INFORMATION
|
|
|
Item
1.
|
Financial
Statements:
|
|
Condensed
Balance Sheets as of September 30, 2006 and December 31,
2005
|
3
|
|
Condensed
Statements of Operations for the Three and Nine Months Ended September
30,
2006 and 2005
|
4
|
|
Condensed
Statements of Cash Flows for the Nine Months Ended September 30,
2006 and
2005
|
5
|
|
Notes
to Condensed Financial Statements
|
6
|
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of Operations
|
15
|
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
20
|
Item
4.
|
Controls
and Procedures
|
21
|
PART II.
OTHER INFORMATION
|
|
|
Item
1A.
|
Risk
Factors
|
21
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
21
|
Item
5.
|
Other
Information
|
22
|
Item
6.
|
Exhibits
|
22
|
Signature
|
|
23
|
2
SUNESIS
PHARMACEUTICALS, INC.
September 30,
|
December 31,
|
||||||
2006
|
2005
|
||||||
(Unaudited)
|
(Note 1)
|
||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
27,678,348
|
$
|
17,704,465
|
|||
Marketable
securities
|
43,551,833
|
30,629,061
|
|||||
Prepaids
and other current assets
|
1,561,514
|
2,068,195
|
|||||
Total
current assets
|
72,791,695
|
50,401,721
|
|||||
Property
and equipment, net
|
4,790,452
|
4,006,527
|
|||||
Deposits
and other assets
|
300,000
|
300,000
|
|||||
Total
assets
|
$
|
77,882,147
|
$
|
54,708,248
|
|||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
2,201,320
|
$
|
2,044,571
|
|||
Accrued
compensation
|
2,144,576
|
2,067,769
|
|||||
Other
accrued liabilities
|
1,513,577
|
1,277,595
|
|||||
Current
portion of deferred revenue
|
2,489,645
|
3,787,453
|
|||||
Current
portion of equipment financing
|
849,309
|
1,067,520
|
|||||
Total
current liabilities
|
9,198,427
|
10,244,908
|
|||||
Non
current portion of deferred revenue
|
1,580,658
|
3,319,765
|
|||||
Non
current portion of equipment financing
|
898,524
|
1,306,027
|
|||||
Deferred
rent and other non-current liabilities
|
1,450,991
|
1,371,346
|
|||||
Commitments
|
|||||||
Stockholders’
equity:
|
|||||||
Preferred
stock, $0.0001 par value; 5,000,000 shares authorized, no shares
issued
and outstanding at September 30, 2006 and December 31,
2005
|
—
|
—
|
|||||
Common
stock, $0.0001 par value; 100,000,000 shares authorized, 29,358,548
and
21,514,007 shares issued and 29,358,548 and 21,511,126 shares outstanding
at September 30, 2006 and December 31, 2005
|
2,936
|
2,151
|
|||||
Additional
paid-in capital
|
297,190,837
|
249,689,714
|
|||||
Deferred
stock compensation
|
(1,225,223
|
)
|
(2,162,688
|
)
|
|||
Accumulated
other comprehensive income (loss)
|
158
|
(55,073
|
)
|
||||
Accumulated
deficit
|
(231,215,161
|
)
|
(209,007,902
|
)
|
|||
Total
stockholders’ equity
|
64,753,547
|
38,466,202
|
|||||
Total
liabilities and stockholders’ equity
|
$
|
77,882,147
|
$
|
54,708,248
|
Note 1: |
The
condensed consolidated balance sheet at December 31, 2005 has been
derived from the audited consolidated financial statements at that
date
included in the Company’s Form 10-K for the fiscal year ended
December 31, 2005.
|
See
accompanying notes to financial statements.
3
SUNESIS
PHARMACEUTICALS, INC.
Three months ended September
30,
|
Nine months ended September
30,
|
||||||||||||
2006
|
2005
|
2006
|
2005
|
||||||||||
(unaudited)
|
(unaudited)
|
||||||||||||
Revenue:
|
|||||||||||||
Collaboration
revenue
|
$
|
237,046
|
$
|
1,685,537
|
$
|
6,124,418
|
$
|
5,028,923
|
|||||
Collaboration
revenue from related party
|
1,712,045
|
1,637,499
|
5,591,890
|
6,880,943
|
|||||||||
Grant
and fellowship revenue
|
—
|
21,942
|
37,901
|
89,347
|
|||||||||
Total
revenues
|
1,949,091
|
3,344,978
|
11,754,209
|
11,999,213
|
|||||||||
Operating
expenses:
|
|||||||||||||
Research
and development
|
8,583,298
|
6,870,942
|
27,146,773
|
28,263,850
|
|||||||||
General
and administrative
|
3,047,583
|
2,067,215
|
8,882,784
|
6,056,145
|
|||||||||
Total
operating expenses
|
11,630,881
|
8,938,157
|
36,029,557
|
34,319,995
|
|||||||||
Loss
from operations
|
(9,681,790
|
)
|
(5,593,179
|
)
|
(24,275,348
|
)
|
(22,320,782
|
)
|
|||||
Interest
income
|
992,261
|
178,515
|
2,495,965
|
574,204
|
|||||||||
Interest
expense
|
(45,970
|
)
|
(229,450
|
)
|
(433,625
|
)
|
(445,975
|
)
|
|||||
Other
income, net
|
1,856
|
2,094
|
5,749
|
8,300
|
|||||||||
Loss
|
(8,733,643
|
)
|
(5,642,020
|
)
|
(22,207,259
|
)
|
(22,184,253
|
)
|
|||||
Convertible
preferred stock deemed dividends
|
-
|
(88,092,302
|
)
|
-
|
(88,092,302
|
)
|
|||||||
Loss
applicable to common stockholders
|
$
|
(8,733,643
|
)
|
$
|
(93,734,322
|
)
|
$
|
(22,207,259
|
)
|
$
|
(110,276,555
|
)
|
|
Basic
and diluted loss per share
|
$
|
(0.30
|
)
|
$
|
(44.57
|
)
|
$
|
(0.82
|
)
|
$
|
(67.58
|
)
|
|
Shares
used in computing basic and diluted loss per share
|
29,333,909
|
2,103,296
|
27,209,536
|
1,631,700
|
See
accompanying notes to financial statements.
4
SUNESIS
PHARMACEUTICALS, INC.
Nine months ended September 30,
|
|||||||
2006
|
2005
|
||||||
(Unaudited)
|
|||||||
Cash
flows from operating activities
|
|||||||
Loss
|
$
|
(22,207,259
|
)
|
$
|
(22,184,253
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
Depreciation
and amortization
|
1,174,805
|
1,278,527
|
|||||
Stock
compensation expense
|
2,062,722
|
930,066
|
|||||
Non-cash
research and development expense
|
1,999,999
|
8,000,000
|
|||||
Changes
in operating assets and liabilities:
|
|||||||
Prepaids
and other current assets
|
506,681
|
(631,678
|
)
|
||||
Notes
and interest receivable from officers and employees
|
—
|
249,070
|
|||||
Accounts
payable
|
156,749
|
602,389
|
|||||
Accrued
compensation
|
76,807
|
(8,031
|
)
|
||||
Other
accrued liabilities
|
235,982
|
608,823
|
|||||
Deferred
rent and other non-current liabilities
|
79,645
|
139,652
|
|||||
Deferred
revenue
|
(3,036,915
|
)
|
(4,495,979
|
)
|
|||
Net
cash used in operating activities
|
(18,950,784
|
)
|
(15,511,414
|
)
|
|||
Cash
flows from investing activities
|
|||||||
Purchases
of property and equipment, net
|
(1,958,730
|
)
|
(1,273,170
|
)
|
|||
Purchases
of marketable securities
|
(38,515,497
|
)
|
(9,980,838
|
)
|
|||
Maturities
of marketable securities
|
25,647,956
|
29,467,435
|
|||||
Proceeds
from sale of property and equipment
|
—
|
1,365
|
|||||
Net
cash (used in) provided by investing activities
|
(14,826,271
|
)
|
18,214,792
|
||||
Cash
flows from financing activities
|
|||||||
Proceeds
from borrowings under debt facility with related party
|
—
|
800,000
|
|||||
Proceeds
from borrowings under note payable and equipment financing
|
238,568
|
1,054,079
|
|||||
Payments
on note payable and equipment loans
|
(864,282
|
)
|
(5,094,011
|
)
|
|||
Proceeds
from issuance of common stock and exercise of options, net of
repurchases
|
44,376,652
|
38,161,997
|
|||||
Net
cash provided by financing activities
|
43,750,938
|
34,922,065
|
|||||
Net
increase in cash and cash equivalents
|
9,973,883
|
37,625,443
|
|||||
Cash
and cash equivalents at beginning of period
|
17,704,465
|
7,587,512
|
|||||
Cash
and cash equivalents at end of period
|
$
|
27,678,348
|
$
|
45,212,955
|
|||
Supplemental
disclosure of cash flow information
|
|||||||
Interest
paid
|
$
|
181,832
|
$
|
445,975
|
|||
Non-cash
activities:
|
|||||||
Conversion
of convertible preferred stock to common stock upon initial public
offering
|
—
|
$
|
116,812,619
|
||||
Deferred
stock-based compensation
|
—
|
$
|
393,708
|
||||
Issuance
of warrants for financing arrangement
|
—
|
$
|
503,300
|
||||
Stock
dividend payable to preferred stockholders
|
—
|
$
|
88,092,302
|
||||
Reversal
of deferred stock-based compensation
|
($
388,836
|
)
|
—
|
||||
Issuance
of common stock for in-licensing agreement
|
$
|
1,999,999
|
$
|
8,000,000
|
See
accompanying notes to financial statements.
5
SUNESIS
PHARMACEUTICALS, INC.
(Unaudited)
1.
Organization and Summary of Significant Accounting
Policies
Organization
Sunesis
Pharmaceuticals, Inc. (“Sunesis” or the “Company”) was incorporated in the
state of Delaware on February 10, 1998, and its facilities are located in
South San Francisco, California. The Company’s initial public offering (“IPO”)
was completed in September 2005. Sunesis is a clinical-stage
biopharmaceutical company focused on discovering, developing and commercializing
novel, small molecule therapeutics for oncology and other unmet medical needs.
The Company’s primary activities since incorporation have been conducting
research and development internally and through corporate collaborators,
in-licensing pharmaceutical compounds, conducting clinical trials, performing
business and financial planning, and raising capital.
Sunesis,
Tethering® and , the Company’s logo, are registered
trademarks of the Company. All other trademarks, trade names and service marks
appearing in this Quarterly Report are the property of their respective
owners.
Use
of 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 amounts reported in the financial statements
and
accompanying notes. Actual results could differ materially from these
estimates.
Basis
of Presentation
The
accompanying unaudited, condensed financial statements have been prepared in
accordance with generally accepted accounting principles for interim financial
information and with the instructions to Form 10-Q and Article 10 of
Regulation S-X. Accordingly, they do not include all of the information and
notes required by U.S. generally accepted accounting principles for complete
financial statements. The financial statements include all adjustments
(consisting only of normal recurring adjustments) that management believes
are
necessary for a fair presentation of the periods presented. The balance sheet
at
December 31, 2005 was derived from the audited financial statements at that
date. These interim financial results are not necessarily indicative of results
to be expected for the full fiscal year.
These
unaudited, condensed financial statements and the notes accompanying them should
be read in conjunction with our Annual Report on Form 10-K for the year
ended December 31, 2005.
Loss
Per Share
Basic
loss per share is calculated by dividing the loss by the weighted-average number
of common shares outstanding for the period, less the weighted average unvested
common shares subject to repurchase. Diluted loss per share is computed by
dividing the loss by the weighted-average number of common shares outstanding,
less the weighted average unvested common shares outstanding which are subject
to repurchase, and dilutive potential common shares for the period determined
using the treasury stock method. For purpose of this calculation, preferred
stock, options to purchase stock, and warrants to purchase stock are considered
to be potential common shares and are only included in the calculation of
diluted loss per common share when their effect is dilutive.
6
The
following table sets forth the computation of basic and diluted net loss per
common share:
Three months ended September 30,
|
Nine months ended September 30,
|
||||||||||||
2006
|
2005
|
2006
|
2005
|
||||||||||
Historical
|
|||||||||||||
Numerator:
|
|||||||||||||
Loss
applicable to common stockholders
|
$
|
(8,733,643
|
)
|
$
|
(93,734,322
|
)
|
$
|
(22,207,259
|
)
|
$
|
(110,276,555
|
)
|
|
Denominator:
|
|||||||||||||
Weighted-average
common shares outstanding
|
29,333,909
|
2,104,590
|
27,209,536
|
1,648,298
|
|||||||||
Less:
Weighted-average unvested common shares subject to
repurchase
|
—
|
(1,294
|
)
|
—
|
(16,598
|
)
|
|||||||
Denominator
for basic and diluted loss per share applicable to common
stockholders
|
29,333,909
|
2,103,296
|
27,209,536
|
1,631,700
|
|||||||||
Basic
and diluted loss per share applicable to common
stockholders
|
$
|
(0.30
|
)
|
$
|
(
44.57
|
)
|
$
|
(0.82
|
)
|
$
|
(67.58
|
)
|
|
Outstanding
securities not included in diluted loss per share
calculation:
|
|||||||||||||
Options
to purchase common stock
|
3,149,677
|
1,707,864
|
3,149,677
|
1,707,864
|
|||||||||
Warrants
|
2,693,237
|
526,373
|
2,693,237
|
526,373
|
|||||||||
5,842,914
|
2,234,237
|
5,842,914
|
2,234,237
|
Comprehensive
Loss
Comprehensive
loss is comprised of loss and other comprehensive income (loss). The Company
includes in other comprehensive income (loss) unrealized gains and losses on
available-for-sale securities. Comprehensive loss is as follows:
Three months ended September 30,
|
Nine months ended September 30,
|
||||||||||||
2006
|
2005
|
2006
|
2005
|
||||||||||
Loss
|
$
|
(8,733,643
|
)
|
$
|
(5,642,020
|
)
|
$
|
(22,207,259
|
)
|
$
|
(22,184,253
|
)
|
|
Change
in unrealized gain on available-for-sale securities
|
12,128
|
21,891
|
55,231
|
39,526
|
|||||||||
Comprehensive
loss
|
$
|
(8,721,515
|
)
|
$
|
(5,620,129
|
)
|
$
|
(22,152,028
|
)
|
$
|
(22,144,727
|
)
|
Accumulated
other comprehensive income (loss) consists of the following:
September
30,
|
December 31,
|
||||||
2006
|
2005
|
||||||
Unrealized
holding gain (loss) on available-for-sale securities and marketable
securities
|
$
|
158
|
$
|
(55,073
|
)
|
Share-Based
Payments
On
January 1, 2006, the Company adopted Statement of Financial Accounting
Standards No. 123 (revised 2004), “Share-Based Payment” (“FAS 123R”), which
supersedes its previous accounting under APB Opinion No. 25, “Accounting
for Stock Issued to Employees” (“APB 25”). FAS 123R requires the recognition of
compensation expense, using a fair-value based method, for costs related to
all
share-based payments including stock options and stock issued under our employee
stock plans. FAS 123R requires companies to estimate the fair value of
share-based payment awards on the date of grant using an option-pricing model.
The value of the portion of the award that is ultimately expected to vest is
recognized as expense on a straight-line basis over the requisite service
periods in Condensed Statements of Operations.
Under
FAS
123R, share-based compensation cost is measured at the grant date, based on
the
estimated fair value of the award, and is recognized as expense over the
employee’s requisite service period. The Company has no awards with market or
performance conditions. The Company adopted the provisions of FAS 123R using
the
modified prospective transition method for awards granted on or after
December 23, 2004, the date on which the Company filed its initial
registration statement on Form S-1 with the Securities and Exchange
Commission (“SEC”) in connection with its IPO. The prospective transition method
has been applied to options granted prior to December 23, 2004. Under the
modified prospective transition method, compensation cost recognized during
the
three and nine months ended September 30, 2006, includes: (a) compensation
cost for all share-based payments granted subsequent to the initial filing
of
the Company’s Form S-1 on December 23, 2004, but not yet vested as of
January 1, 2006, based on the grant date fair value estimated in accordance
with the original provisions of SFAS No. 123 (as defined below) and
amortized on a straight-line basis over the options’ vesting period; and
(b) compensation cost for all share-based payments granted subsequent to
January 1, 2006, based on the grant-date fair value estimated in accordance
with the provisions of FAS 123R amortized on a straight-line basis over the
options’ vesting period. Under the prospective transition method, options
granted prior to the initial filing of the Company’s Form S-1 will continue
to be accounted for in accordance with APB 25 and Financial Accounting
Standards Board (“FASB”) Interpretation No. 44 (“FIN 44”), Accounting
for Certain Transactions Involving Stock Compensation, an Interpretation of
APB
No. 25,
which
were the accounting principles originally applied to those awards.
7
The
valuation provisions of FAS 123R apply to new awards and to awards that are
outstanding on the effective date and subsequently modified or cancelled.
Estimated compensation expense for awards outstanding at the effective date
will
be recognized over the remaining service period using the compensation cost
calculated for pro forma disclosure purposes under FASB Statement No. 123,
Accounting
for Stock-Based Compensation
(“SFAS
123”). As stock-based compensation expense recognized in the Condensed Statement
of Operations for the first nine months of fiscal 2006 is based on awards
ultimately expected to vest, it 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. The Company intends to review its forfeiture estimates on a quarterly
basis. In the Company’s pro forma information required under SFAS 123 for the
periods prior to fiscal 2006, the Company accounted for forfeitures as they
occurred. The Company’s Condensed Financial Statements for prior periods have
not been restated to reflect, and do not include, the impact of FAS
123R.
Upon
adoption of FAS 123R, the Company retained its method of valuation for
share-based awards granted beginning in fiscal 2006 with the use of the
Black-Scholes option-pricing model (“Black-Scholes model”) which was previously
used for the Company’s pro forma information required under SFAS 123. The
Company’s determination of fair value of share-based payment awards on the date
of grant using an option-pricing model is affected by the Company’s stock price
as well as assumptions regarding a number of highly complex and subjective
variables. These variables include, but are not limited to, the Company’s
expected stock price volatility over the term of the awards, and actual and
projected employee stock option exercise behaviors.
FAS
123R
requires the cash flows resulting from the tax benefits related to tax
deductions in excess of the compensation costs recognized for these options
(excess tax benefits) to be classified as financing cash flows.
On
November 10, 2005, the FASB issued FASB Staff Position No. FAS
123(R)-3, “Transition Election Related to Accounting for Tax Effects of
Share-Based Payment Awards.” The Company has elected to adopt the alternative
transition method provided in the FASB Staff Position for calculating the tax
effects of share-based compensation pursuant to FAS 123R. The alternative
transition method includes a simplified method to establish the beginning
balance of the additional paid-in capital pool related to the tax effects of
employee share-based compensation, which is available to absorb tax deficiencies
recognized subsequent to the adoption of FAS 123R.
Share-Based
Compensation Information under FAS 123R
The
weighted-average estimated fair value of employee stock options granted during
the nine months ended September 30, 2006 and September 30, 2005 was $3.87 and
$12.21 per
share, respectively, using the Black-Scholes model with the following
assumptions (annualized percentages):
Three months ended September 30,
|
Nine
months ended September 30,
|
||||||||||||
2006
|
2005
|
2006
|
2005
|
||||||||||
Volatility
|
80.00
|
%
|
80.00
|
%
|
80.00
|
%
|
80.00
|
%
|
|||||
Risk-free
interest rate
|
4.75
|
%
|
3.9
|
%
|
4.89
|
%
|
3.80
|
%
|
|||||
Dividend
yield
|
none
|
none
|
none
|
none
|
|||||||||
Annual
forfeiture rate
|
5.26
|
%
|
none
|
5.26
|
%
|
none
|
|||||||
Expected
term (years)
|
5.00
|
5.00
|
5.00
|
5.00
|
The
weighted-average estimated fair value of employee stock options granted during
the three months ended September 30, 2006 and September 30, 2005 was $3.31
and
$11.94 per share, respectively. The Company recorded $114,685 and $138,791,
respectively, in share-based compensation expense during the three and nine
months ended September 30, 2006 related to share-based awards granted during
the
first nine months of 2006.
The
weighted average estimated fair value of purchase rights under our Employee
Stock Purchase Plan (“ESPP”) for the three and nine months ended September 30,
2006 was $2.58 and $2.82 per share using the Black-Scholes model with the
following assumptions:
8
Three months ended
|
Nine months ended
|
||||||
September 30, 2006
|
September 30, 2006
|
||||||
Volatility
|
80.00
|
%
|
80.00
|
%
|
|||
Risk-free
interest rate
|
4.36%
- 5.06
|
%
|
3.90%
- 5.06
|
%
|
|||
Dividend
yield
|
none
|
none
|
|||||
Annual
forfeiture rate
|
5.26
|
%
|
5.26
|
%
|
|||
Expected
term (years)
|
0.50
- 1.00
|
0.50
- 1.00
|
The
Company has based its assumptions for volatility and expected term of employee
stock options on the information available with respect to its mature peer
group
in the same industry. The expected term of the employees’ purchase rights is
equal to the purchase period. The assumption for volatility has not changed
due
to the adoption of FAS 123R. The risk-free interest rate assumption is based
upon observed interest rates appropriate for the expected life of the Company’s
employee stock options and employees’ purchase rights. The Company does not
anticipate paying any cash dividends in the foreseeable future and therefore
uses an expected dividend yield of zero in the option valuation model. The
post-vesting forfeiture rate is derived from the Company’s historical option
cancellation information.
As
a
result of adopting FAS 123R on January 1, 2006, the Company’s loss for the
three and nine months ended September 30, 2006 is $472,581 and $1,300,335
larger, respectively, than if it had continued to account for share-based
compensation under APB 25. Basic and diluted loss per share for the quarter
ended September 30, 2006 are $0.30 and $0.02 lower, respectively, than if the
Company had continued to account for share-based compensation under APB 25.
Basic and diluted loss per share for the nine months ended September 30, 2006
are $0.82 and $0.05 lower, respectively, than if the Company had continued
to
account for share-based compensation under APB 25.
Stock
Compensation for Options Granted Prior to the IPO
Prior
to
the Company’s IPO, certain stock options were granted with exercise prices that
were below the reassessed fair value of the common stock at the date of grant.
In accordance with APB 25, deferred stock compensation was recorded for the
difference between the estimated fair value of the common stock underlying
the
options and the exercise price of the options. The deferred stock compensation
is being amortized over the related vesting terms of the options. The Company
recorded amortization of deferred stock compensation of $182,056 and $548,631,
respectively, in the three and nine months ended September 30, 2006 under the
prospective transition method of FAS 123R for stock options granted before
December 23, 2004, the date on which the Company filed its initial
registration statement on Form S-1 in connection with its IPO. For stock
options granted after December 23, 2004, the associated unamortized
deferred compensation balance of $304,820 was reversed as of January 1,
2006 due to the adoption of FAS 123R.
As
of
September 30, 2006, the expected future amortization expense for deferred stock
compensation during each of the following periods is as follows:
Year ending December 31,
|
||||
2006
remaining period
|
$
|
176,801
|
||
2007
|
707,204
|
|||
2008
|
341,218
|
|||
Total
amount to be amortized
|
$
|
1,225,223
|
Total
Share-based Compensation Expense
Employee
stock-based compensation expense recognized in the first nine months of 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. Employee stock-based compensation expense related
to all of the Company’s share-based awards, including, stock options granted
prior to the Company’s IPO which continue to be accounted for under APB 25, is
as follows:
Three months ended
|
Nine months ended
|
||||||
September 30, 2006
|
September 30, 2006
|
||||||
Research
and development
|
$
|
289,588
|
$
|
898,507
|
|||
General
and administrative
|
396,408
|
1,067,036
|
|||||
Share-based
compensation expense before taxes
|
685,996
|
1,965,543
|
|||||
Related
income tax benefits
|
—
|
—
|
|||||
Share-based
compensation expense, net of taxes
|
$
|
685,996
|
$
|
1,965,543
|
9
Pro
Forma Information under SFAS 123 for Periods Prior to Fiscal
2006
Prior
to
January 1, 2006, the Company followed the disclosure-only provisions of
SFAS 123, as amended. The following table illustrates the effect on net loss
and
loss per common share for the three and nine months ended September 30, 2005
if
the fair value recognition provisions of SFAS 123, as amended, had been applied
to options granted under the Company’s equity-based employee compensation plans.
For purposes of this pro forma disclosure, the estimated value of the options
is
recognized over the options’ vesting periods. If the Company had recognized the
expense of equity programs in the statement of operations, additional paid-in
capital would have increased by a corresponding amount, net of applicable taxes.
For stock options accounted for under the prospective transition method
consisting of those options granted prior to the initial filing of the Company’s
Form S-1, no pro forma disclosures have been provided.
Three months ended
|
Nine months ended
|
||||||
September 30, 2005
|
September 30, 2005
|
||||||
Loss,
as reported
|
$
|
(93,734,322
|
)
|
$
|
(110,276,555
|
)
|
|
Add:
employee stock compensation expense based on the intrinsic value
method
|
258,765
|
717,022
|
|||||
Deduct:
total employee stock-based compensation expense determined under
the fair
value method for all awards
|
(485,402
|
)
|
(1,248,969
|
)
|
|||
Pro
forma loss
|
$
|
(93,960,959
|
)
|
$
|
(110,808,502
|
)
|
|
Loss per
share:
|
|||||||
Basic
and diluted, as reported
|
$
|
(44.57
|
)
|
$
|
(67.58
|
)
|
|
Basic
and diluted, pro forma
|
$
|
(44.67
|
)
|
$
|
(67.91
|
)
|
2.
License Agreements
Dainippon
Sumitomo Pharma
In
October 2003, the Company entered into an agreement with Dainippon Sumitomo
Pharma Co., Ltd. (“Dainippon”) to acquire exclusive worldwide development and
marketing rights for Dainippon’s anti-cancer compound, referred to as
SNS-595.
Under
the
terms of the agreement, the Company made a non-refundable payment of $700,000,
which was included in research and development expense in 2003. In addition
to
this payment, the Company may in the future make a series of milestone
payments of up to $8.0 million to Dainippon based on successful development
and
regulatory approval of SNS-595 for cancer indications, as well as royalty
payments based on any future product sales. In return, the Company has received
an exclusive, worldwide license to develop and market SNS-595. In
December 2005, the Company accrued a $500,000 milestone payment upon
commencement of Phase II clinical trials as research and development expense
and
this milestone payment was made in February 2006.
Bristol-Myers
Squibb Company
In
April 2005, the Company entered into an agreement with Bristol-Myers Squibb
Company (“BMS”) to acquire worldwide development and commercialization rights
for BMS’ anti-cancer compound, referred to as SNS-032.
Under
the
terms of this agreement, the Company made an up-front $8.0 million equity
payment through the issuance of shares of the Company’s Series C-2
preferred stock. This amount was included in research and development expense
for the year ended December 31, 2005 due to uncertainties surrounding the
remaining efforts
for completion of the research and development activities. The Company
may in the future make a series of milestone payments of up to
$29.0 million in cash, equity or any combination thereof to BMS based on
the successful development and approval for the first indication and formulation
of SNS-032. In addition, the Company may make a series of development
and commercialization milestone payments totaling up to $49.0 million
in
cash,
equity or any combination thereof, as well as royalty payments based on any
future product sales. In return, the Company received worldwide exclusive and
non-exclusive diagnostic and therapeutic licenses to SNS-032 and future
cyclin-dependent kinase (“CDK”) inhibitors derived from related intellectual
property. In February 2006, upon commencement of a Phase I/II clinical
trial, the Company made a $2.0 million non-cash milestone payment to BMS through
the issuance of 404,040 shares of the Company’s common stock.
10
3.
Collaborative Research Agreements
Johnson &
Johnson Pharmaceutical Research and Development,
L.L.C.
In
May 2002, the Company entered into a research collaboration to discover
small molecule inhibitors of Cathepsin S with Johnson & Johnson
Pharmaceutical Research & Development, L.L.C (“J&J PRD”). The
Company applies its proprietary Tethering® technology to discover novel
inhibitors of Cathepsin S in this collaboration.
Under
the
terms of the agreement, the Company received a non-refundable and non-creditable
technology access fee of $500,000 in February 2003, and certain research
funding to be paid in advance quarterly. The Company may in the future
receive research and development milestones of up
to
$24.5
million
as well as royalty payments from J&J PRD based on future product sales. On
December 15, 2002, the Company and J&J PRD amended their collaboration
to increase the number of J&J PRD funded full-time equivalents for 2003. In
December 2002, J&J PRD also made the first milestone payment of
$250,000 to the Company for the delivery of a novel lead series of
compounds. On December 15, 2003, the Company and J&J PRD again amended
their collaboration to extend the research funding for one additional year
from
May 3, 2004 through May 2, 2005. On December 22, 2004, the
Company and J&J PRD amended their collaboration to extend the research
funding from May 3, 2005 until December 31, 2005. Costs associated
with research and development activities attributable to this agreement
approximate the research funding recognized.
Biogen
Idec, Inc.
In
December 2002, the Company entered into a research collaboration with
Biogen Idec, Inc. (“Biogen Idec”) to discover oral therapeutics. The
collaboration applies the Company’s proprietary Tethering® technology to
generate small molecule leads to selected TNF-family cytokines involved in
immune and inflammatory disease and two additional un-named
targets.
During
the initial phase of the collaboration, both companies contributed scientists
and discovery resources to the collaboration at their own cost. Under an
exclusive, worldwide license to compounds resulting from these efforts, Biogen
Idec has the right to develop, manufacture, and commercialize compounds
discovered under the collaboration.
Under
the
terms of the agreement, the Company received an upfront, non-refundable and
non-creditable technology access fee of $3.0 million which was being recognized
as revenue over the 30-month term of the agreement and the one-year option
period. In addition, the Company started receiving quarterly maintenance fees
of
$357,500 commencing April 1, 2004, and the Company may in the future
receive research and development milestones of up to $60.5 million and royalty
payments based on total annual future product sales. In certain circumstances,
such as the cessation of the development of particular compounds, milestone
payments received may be credited against future milestone payments with
respect to compounds directed to the same target as the discontinued compound.
As such, the Company recognizes the milestones received as revenue ratably
over
the remaining term of the agreement. On June 18, 2005, the one-year option
was not exercised by Biogen Idec and the research term of the agreement was
completed. Accordingly, the remaining deferred revenue of $824,872 was
recognized in the second quarter of 2005.
On
August 27, 2004, the Company entered into the second research collaboration
with Biogen Idec to discover and develop small molecules targeting kinases,
a
family of cell signaling enzymes that play a role in the progression of cancer.
The Company applies its proprietary Tethering® technology to generate novel,
small molecule leads that inhibit the oncology kinase targets that are covered
by this collaboration.
One
of
the kinase targets in the collaboration is Raf, and the Company’s Raf program
was folded into the collaboration. Under the terms of the agreement, the Company
received a $7.0 million upfront, non-refundable and non-creditable technology
access fee, which is being recognized as revenue over an initial four-year
research term. In the event that Biogen Idec decides to exercise its option
to
extend the initial four-year research term for one additional year, Biogen
Idec
will pay the Company an additional technology access fee specified in the
agreement. In addition, the Company will receive quarterly research funding
of
$1.2 million to be paid in advance to support some of its scientific
personnel, and the Company may in the future receive pre-commercialization
milestone payments of up to $60.5 million
and
royalty
payments based on any product sales. The Company retains an option to
participate in the co-development and co-promotion of product candidates for
up
to two targets that may emerge from this collaboration.
Concurrent
with the signing of the agreement in 2004, Biogen Idec made a $14.0 million
equity investment and purchased shares of the Company’s Series C-2
preferred stock.
In
May
2006, the Company received a milestone payment of $500,000 from Biogen Idec
for
the discovery of novel inhibitors of an oncology kinase target and this amount
was recognized as revenue in the second quarter of 2006.
11
Merck &
Co., Inc.
In
February 2003, the Company and Merck & Co., Inc. (“Merck”)
entered into a research collaboration to identify and optimize inhibitors of
BACE, an Alzheimer’s disease target. This collaboration had an initial
three-year research term and both parties agreed to dedicate the resource
funding provided in the research plan. Merck elected not to exercise its option
to extend the research term for an additional one-year period, and the research
term of this collaboration ended in February 2006. However, the Company
will retain the right to earn milestone payments and royalties on any compound
that results from the collaboration.
On
July 22, 2004, the Company and Merck entered into a multi-year research
collaboration to discover novel oral drugs for the treatment of viral
infections. The Company provided Merck with a series of small molecule
compounds targeting viral infections. These compounds were derived from
Tethering®. Merck will be responsible for advancing these compounds into lead
optimization, preclinical development, and clinical studies. Merck will pay
annual license fees for the Company’s consulting services and ongoing access to
Tethering® as a means of identifying additional compounds for the treatment of
viral infections.
Under
the
terms of the agreement, the Company received an upfront, non-refundable and
non-creditable technology access fee of $2.3 million which is being
recognized as revenue over an initial three-year research term, annual license
fees aggregating $950,000 and payments based on the achievement of development
milestones of up to $22.1 million.
In
addition, the Company will receive royalty payments based on net sales for
any
products resulting from the collaboration. Merck receives an exclusive,
worldwide license to any products resulting from the collaboration.
In
June
2006, the Company received two milestone payments totaling $4.25 million from
Merck for the achievement of preclinical milestones and this amount was
recognized as revenue in the second quarter of 2006.
In
connection with the above collaboration agreements, the Company recognized
the
following revenues, which include the amortization of upfront fees received,
research funding, and milestones earned:
Three months ended September
30,
|
Nine months ended September
30,
|
||||||||||||
2006
|
2005
|
2006
|
2005
|
||||||||||
J&J
PRD
|
$
|
—
|
$
|
357,569
|
$
|
—
|
$
|
1,059,991
|
|||||
Merck
|
237,046
|
1,327,968
|
6,124,418
|
3,968,932
|
|||||||||
237,046
|
1,685,537
|
6,124,418
|
5,028,923
|
||||||||||
Biogen
Idec-related party
|
1,712,045
|
1,637,499
|
5,591,890
|
6,880,943
|
|||||||||
Total
collaboration revenue
|
$
|
1,949,091
|
$
|
3,323,036
|
$
|
11,716,308
|
$
|
11,909,866
|
4.
Debt Facility
In
August 2005, the Company entered into a Venture Loan and Security Agreement
with Oxford Finance Corporation and Horizon Technology Funding Company LLC,
pursuant to which the Company could borrow up to $15.0 million. The full $15.0
million loan commitment was available until October 15, 2005, $10.0 million
was available until January 31, 2006, and the remaining $5.0 million was
available until May 31, 2006. This facility expired on May 31, 2006, and
the Company had not drawn any amount under this facility. In connection with
this transaction, the Company issued warrants to the lenders to purchase shares
of Series C preferred stock, which converted into warrants to purchase
164,830 shares of common stock in connection with the IPO. The warrants expire
ten years from the date of issuance. The Company also granted the lenders
registration rights under the Company’s Eighth Amended and Restated Investor
Rights Agreement.
The
fair
value of the warrants issued is $498,438, as determined using the Black-Scholes
model, and were being accounted for as prepaid interest and expensed on a
straight-line basis through May 31, 2006.
Contingencies
From
time
to time, the Company may become involved in claims and other legal matters
arising in the ordinary course of business. As of September 30, 2006, management
is not aware of any matters that could have a material adverse effect on the
financial position, results of operations or cash flows of the
Company.
5.
Stockholders’ Equity
In
March 2006, the Company entered into a Common Stock and Warrant Purchase
Agreement pursuant to which it sold to certain investors, for an aggregate
purchase price of approximately $45.3 million, 7,246,377 shares of its
common stock and warrants to purchase up to 2,173,914 additional shares of
its
common stock. The purchase price for the common stock and the exercise price
for
the warrants is $6.21 per share. Investors in the financing paid an
additional purchase price equal to $0.125 for each share of common stock
underlying the warrants. All securities were sold in a private placement exempt
from registration under the Securities Act of 1933, as amended by virtue of
Section 4(2) and/or Regulation D promulgated thereunder as
transactions not involving any public offering. The Company received net
proceeds of approximately $43.7 million in this offering.
12
6.
Employee Benefit Plans
Stock
Option Plans
With
regard to option granting, the Company generally grants options (i) to new
employees which become exercisable 25% on the first anniversary of the vesting
commencement date and then 1/48th for each month thereafter, and (ii) to
existing employees which become exercisable 1/48th the month following the
grant
date and then at the rate of 1/48th each month thereafter.
2005
Equity Incentive Award Plan
In
February 2005, the Board of Directors adopted and in September 2005,
the stockholders approved the 2005 Equity Incentive Award Plan (“2005 Plan”).
The Company initially reserved a total of 1,779,396 shares of common stock
for
issuance under the 2005 Plan plus any options granted under the Company’s
predecessor plans that expire unexercised or are repurchased by the Company
pursuant to the terms of such options. As of September 30, 2006, 1,537,473
shares have been granted under the 2005 Plan.
The
number of shares of common stock reserved under the 2005 Plan will automatically
increase on the first trading day each year, beginning in 2006, by an amount
equal to the least of: (i) 4% of the Company’s outstanding shares of common
stock outstanding on such date, (ii) 1,082,352 shares, or (iii) a
lesser amount determined by the Board of Directors. On January 1, 2006, the
2005 Plan was increased by 860,445 shares according to this provision and based
on Board approval. The total shares available for future grants under this
2005
Plan as of September 30, 2006 was 1,197,140. The maximum aggregate number of
shares which may be issued or transferred over the term of the 2005 Plan is
11,294,112 shares. In addition, no participant in the 2005 Plan may be
issued or transferred more than 235,294 shares of common stock per calendar
year
pursuant to awards under the 2005 Plan.
2006
Employment Commencement Incentive Plan
In
November 2005, the Board of Directors adopted the 2006 Employment
Commencement Incentive Plan (“2006 Plan”), which became effective on
January 1, 2006. The awards granted pursuant to the 2006 Plan are intended
to be inducement awards pursuant to Nasdaq Marketplace
Rule 4350(i)(1)(A)(iv). The 2006 Plan is not subject to the approval of the
Company’s stockholders. An aggregate of up to 200,000 shares of common stock
may be issued pursuant to awards under the 2006 Plan. Only those employees
who have not previously been employees or directors of the Company or a
subsidiary of the Company, or following a bona fide period of non-employment
by
the Company or a subsidiary of the Company, are eligible to participate in
the
2006 Plan. Additionally, grants awarded to such employees under the 2006 Plan
must be made in connection with his or her commencement of employment with
the
Company or a subsidiary of the Company and must be an inducement material to
his
or her entering into employment with the Company or a subsidiary of the Company.
As of September 30, 2006, 100,000 shares have been granted under the 2006
Plan.
A
summary of stock option transactions for all stock option plans
follows:
Number
of Shares
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Term (years)
|
Aggregate
Intrinsic
Value
(in thousands)
|
||||||||||
Outstanding
at December 31, 2005
|
2,994,701
|
$
|
3.92
|
||||||||||
Options
granted
|
341,400
|
$
|
5.75
|
||||||||||
Options
exercised
|
(98,928
|
)
|
$
|
2.50
|
|||||||||
Options
canceled/forfeited/expired
|
(87,496
|
)
|
$
|
4.87
|
|||||||||
Balance
at September 30, 2006
|
3,149,677
|
$
|
4.14
|
7.81
|
$
|
3,763
|
|||||||
Exercisable
at September 30, 2006
|
1,587,448
|
$
|
3.20
|
6.62
|
$
|
3,213
|
13
The
following table summarizes outstanding and exercisable options as of September
30,
2006:
OPTIONS OUTSTANDING
|
OPTIONS EXERCISABLE
|
|||||||||||||||
Range of
Exercise Prices
|
Number
Outstanding
As of
September
30,
2006
|
Weighted
Average
Remaining
Contractual
Term
|
Weighted
Average
Exercise
Price
|
Number
Exercisable
As of
September
30,
2006
|
Weighted
Average
Exercise
Price
|
|||||||||||
$
0.43- $ 1.28
|
25,882
|
2.96
|
$
|
0.82
|
25,882
|
$
|
0.82
|
|||||||||
$
2.55
|
1,413,291
|
6.18
|
$
|
2.55
|
1,217,184
|
$
|
2.55
|
|||||||||
$
3.19 - $ 5.16
|
218,609
|
9.36
|
$
|
4.59
|
32,058
|
$
|
3.59
|
|||||||||
$
5.25
|
1,208,096
|
9.16
|
$
|
5.25
|
252,606
|
$
|
5.25
|
|||||||||
$
5.82 - $ 6.01
|
66,000
|
9.71
|
$
|
6.00
|
15,000
|
$
|
6.01
|
|||||||||
$
6.21
|
60,000
|
9.74
|
$
|
6.21
|
—
|
$
|
—
|
|||||||||
$
6.35
|
24,400
|
9.67
|
$
|
6.35
|
—
|
$
|
—
|
|||||||||
$
6.40
|
23,900
|
9.58
|
$
|
6.40
|
—
|
$
|
—
|
|||||||||
$
7.15
|
22,400
|
9.50
|
$
|
7.15
|
—
|
$
|
—
|
|||||||||
$
9.56
|
87,099
|
8.69
|
$
|
9.56
|
44,718
|
$
|
9.56
|
|||||||||
$
0.43 - $ 9.56
|
3,149,677
|
7.81
|
$
|
4.14
|
1,587,448
|
$
|
3.20
|
The
Company’s determination of the fair value of share-based payment awards on the
grant date using an option-pricing model is affected by the Company’s stock
price as well as assumptions regarding a number of highly subjective variables.
The total estimated grant date fair value of stock options that were granted
during the three and nine months ended September 30, 2006 was approximately
$407,000 and $1,309,000, respectively. The estimated fair value of shares vested
during the third quarter and the first nine months of 2006 was $419,000 and
$1,373,000, respectively, and was zero for both the third quarter and the first
nine months of 2005. At September 30, 2006, total unrecognized estimated
compensation cost related to non-vested stock options granted prior to that
date
was $5.9 million and the cost is expected to be recognized over a weighted
average period of 2.36 years.
The
total intrinsic value of stock options exercised during the three and nine
months ended September 30, 2006 was $96,000 and $300,000, respectively. The
Company recorded cash received from the exercise of stock options of $97,000
and
$247,000, respectively during the three and nine months ended September 30,
2006. As it is more likely than not that all of the stock option related tax
benefits will not be realized, the Company did not record net tax benefits
related to the options exercised in the three and nine months ended September
30, 2006.
Employee
Stock Purchase Plan
In
February 2005, the Board of Directors adopted and in September 2005,
the stockholders approved the 2005 Employee Stock Purchase Plan (“ESPP”). The
Company initially reserved a total of 202,941 shares of common stock for
issuance under the ESPP. The ESPP permits eligible employees to purchase common
stock at a discount through payroll deductions during defined offering periods.
Eligible employees can purchase shares of the Company’s common stock at 85% of
the lower of the fair market value of the common stock at the beginning of
an
offering period or at the purchase date. As of September 30, 2006, 88,777 shares
have been issued under the ESPP.
The
number of shares of common stock reserved under the ESPP will automatically
increase on the first trading day each year, beginning in 2006, by an amount
equal to the least of: (i) 0.5% of the Company’s outstanding shares of
common stock outstanding on such date, (ii) 135,294 shares, or (iii) a
lesser amount determined by the Board of Directors. On January 1, 2006, the
ESPP was increased by 107,556 shares according to this provision and based
on
Board approval. At September 30, 2006, the total shares reserved for future
issuance under the ESPP was 221,720. The maximum aggregate number of shares
which may be issued over the term of the ESPP is 1,352,941 shares. In
addition, no participant in the ESPP may be issued or transferred more than
$25,000 of shares of common stock per calendar year pursuant to awards under
the
ESPP. No one may purchase more than 1,176 shares during any purchase period.
The
total estimated fair value of purchase rights outstanding under the ESPP that
vested during the three and nine months ended September 30, 2006 was
approximately $73,000 and $295,000, respectively.
14
The
following is a summary of outstanding options for the current offering period
based upon the estimated contribution for two consecutive purchase
periods:
Number
of Shares
|
Weighted
Average
Exercise Price
|
Weighted
Average
Remaining
Contractual
Term (years)
|
Aggregate
Intrinsic
Value
(in thousands)
|
||||||||||
Vested
and expected to vest at September 30, 2006
|
59,019
|
$
|
4.66
|
0.20
|
$
|
28
|
7.
Guarantees and Indemnification
In
November 2002, the FASB issued Interpretation No. 45, “Guarantor’s
Accounting and Disclosure Requirements for Guarantees, including Indirect
Guarantees of Indebtedness of Others” (“FIN 45”). FIN 45 requires that upon
issuance of a guarantee, the guarantor must recognize a liability for the fair
value of the obligations it assumes under that guarantee.
As
permitted under Delaware law and in accordance with the Company’s Bylaws, the
Company indemnifies its officers and directors for certain events or
occurrences, subject to certain limits, while the officer or director is or
was
serving at the Company’s request in such capacity. The indemnification
agreements with the Company’s officers and directors terminate upon termination
of their employment, but the termination does not affect claims for
indemnification relating to events occurring prior to the effective date of
termination. The maximum amount of potential future indemnification is
unlimited; however, the Company’s officer and director insurance policy reduces
the Company’s exposure and may enable the Company to recover a portion of
any future amounts paid. The Company believes that the fair value of these
indemnification agreements is minimal. Accordingly, the Company has not recorded
any liabilities for these agreements as of September 30, 2006.
Item
2. Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
The
following discussion and analysis of our financial condition as of September
30,
2006 and results of operations for the three and nine months ended September
30,
2006 and 2005 should be read together with our financial statements and related
notes included elsewhere in this report. This discussion and analysis contains
forward-looking statements that involve risks, uncertainties and assumptions.
Our actual results may differ materially from those anticipated in these
forward-looking statements as a result of many factors, including but not
limited to those set forth under “Risk Factors” and elsewhere in this report. We
urge you not to place undue reliance on these forward-looking statements, which
speak only as of the date of this report. All forward-looking statements
included in this report are based on information available to us on the date
of
this report, and we assume no obligation to update any forward-looking
statements contained in this report.
In
this
report, “Sunesis,” the “Company,” “we,” “us,” and “our” refer to Sunesis
Pharmaceuticals, Inc.
Business
Overview
We
are a
clinical-stage biopharmaceutical company focused on the discovery, development
and commercialization of novel, small molecule therapeutics for oncology and
other unmet medical needs. We have developed a proprietary fragment-based drug
discovery approach, called “Tethering®,” that we combine with other drug
discovery tools, such as structure-based design and medicinal chemistry, to
discover and develop novel therapeutics. We have built our product candidate
portfolio through internal discovery and the in-licensing of novel cancer
therapeutics. We are advancing our product candidates through in-house research
and clinical development efforts and strategic collaborations with leading
pharmaceutical and biopharmaceutical companies.
From
our
incorporation in 1998 through 2001, our operations consisted primarily of
developing and refining our drug discovery technologies. Since 2002, we have
focused on developing novel, small molecule drugs mainly to treat cancer and
other unmet medical needs.
We
are
advancing three proprietary oncology product candidates, SNS-595, SNS-032 and
SNS-314, through in-house research and development efforts. Our lead product
candidate, SNS-595, is a novel cell cycle inhibitor. With SNS-595, we are
currently conducting one Phase II clinical trial in small cell lung cancer,
one Phase II clinical trial in non-small cell lung cancer and a Phase I
clinical trial in acute leukemias. We plan to initiate a Phase II trial in
patients with ovarian cancer by the end of 2006. We in-licensed this compound
from Dainippon in October 2003. Our second most advanced product candidate,
SNS-032, is a CDK inhibitor. We are currently conducting a Phase I/II
clinical trial with SNS-032 in patients with advanced solid tumors. We plan
to
initiate a Phase I trial in patients with advanced B-lymphoid malignancies
in
early 2007. We in-licensed this compound from BMS in April 2005. We are
also developing SNS-314, an Aurora kinase inhibitor, for the treatment of
cancer, and we expect to file an investigational new drug application (“IND”) in
early 2007. We have worldwide development and commercialization rights to
SNS-595, SNS-032 (for diagnostic and therapeutic applications) and SNS-314.
We
may in the future enter into collaborations to maximize the commercial
potential of these programs.
15
As
of
October 31, 2006, we had four ongoing strategic collaborations, one of which
involves active participation by our personnel, with three leading
pharmaceutical and biopharmaceutical companies. These alliances have been
designed to enable us to leverage and expand our internal development
capabilities, manage our cash expenditures and diversify risk across our
pipeline. As of September 30, 2006, we had received an aggregate of
approximately $76.0 million in cash in the form of stock purchase
proceeds, fees and loans from our collaboration partners.
Since
our
inception, we have generated significant losses. As of September 30, 2006,
we
had an accumulated deficit of $231.2 million, including an $88.1 million
deemed dividend recorded as of September 30, 2005 in connection with the closing
of our IPO and the conversion of preferred stock to common stock. We expect
our
net losses to increase primarily due to our anticipated clinical trial
activities.
Critical
Accounting Policies and Significant Judgments and
Estimates
This
discussion and analysis of our financial condition and results of operations
is
based on our financial statements, which have been prepared in accordance with
U.S. generally accepted accounting principles. The preparation of these
financial statements requires management to make estimates and judgments that
affect the reported amounts of assets, liabilities and expenses and the
disclosure of contingent assets and liabilities at the date of the financial
statements, as well as revenue and expenses during the reporting periods. We
evaluate our estimates and judgments on an ongoing basis. We base our estimates
on historical experience and on various other factors we believe are reasonable
under the circumstances, the results of which form the basis for making
judgments about the carrying value of assets and liabilities that are not
readily apparent from other sources. Actual results could therefore differ
materially from those estimates under different assumptions or
conditions.
An
accounting policy is deemed to be critical if it requires an accounting estimate
to be made based on assumptions about matters that are highly uncertain at
the
time the estimate is made, and if different estimates that reasonably could
have
been used, or changes in the accounting estimate that are reasonably likely
to
occur periodically, could materially change the financial statements. We believe
there have been no significant changes during the three and nine months ended
September 30, 2006 to the items that we disclosed as our critical accounting
policies and estimates under Item 7, “Management’s Discussion and Analysis of
Financial Condition and Results of Operations,” in our Annual Report on
Form 10-K for the year ended December 31, 2005, with the exception of
our estimates related to the recording of expenses for share-based
payments.
Share-Based
Payments
We
grant
options to purchase our common stock to our employees, directors and consultants
under our stock option plans. Eligible employees can also purchase shares of
our
common stock at 85% of the lower of the fair market value of the common stock
at
the beginning of an offering period or at the purchase date. The benefits
provided under these plans are share-based payments subject to the provisions
of
FAS 123R. Effective January 1, 2006, we use the fair value method to apply
the provisions of FAS 123R with a modified prospective application to awards
granted on or after December 23, 2004, the date on which we filed our
initial registration statement on Form S-1 with the SEC in connection with
our IPO. The valuation provisions of FAS 123R apply to new awards and to awards
that are outstanding on the effective date and subsequently modified or
cancelled. Under the modified prospective application, prior periods are not
revised for comparative purposes. The prospective transition method has been
applied to options granted prior to December 23, 2004. Under the
prospective transition method, options granted prior to the initial filing
of
our Form S-1 will continue to be accounted for in accordance with APB 25
and FIN 44 which were the accounting principles originally applied to those
awards.
Upon
adoption of FAS 123R, we continue to estimate the value of share-based awards
on
the date of grant using the Black-Scholes model, as we disclosed for the pro
forma information required under SFAS 123.
Estimates
of share-based compensation expenses are significant to our financial
statements, but these expenses are based on the aforementioned option valuation
model and will never result in the payment of cash by us. For this reason,
and
because we do not view share-based compensation as related to our operational
performance, we exclude estimated share-based compensation expense when
evaluating business performance.
The
guidance in FAS 123R and the SEC’s Staff Accounting Bulletin No. 107 is
relatively new, and best practices are not well established. The application
of
these principles may be subject to further interpretation and refinement
over time. There are significant differences among valuation models, and there
is the possibility that we will adopt different valuation models in the future.
This may result in a lack of consistency in future periods and materially
affect the fair value estimate of share-based payments. It may also result
in a lack of comparability with other companies that use different models,
methods and assumptions.
16
Results
of Operations
Three
and Nine Months Ended September 30, 2006 and 2005
Revenue.
We
have
not generated any revenue from sales of commercial products and do not expect
to
generate any product revenue for the foreseeable future. To date, our revenue
has consisted of collaboration revenue and grant and fellowship
revenue.
Collaboration
Revenue.
We
generate revenue primarily through our collaborations. We currently have four
ongoing research-based collaborations. These collaborations include a technology
access fee, research funding, milestone payments and royalties upon sales of
future products that may result from the collaborations. The table below
sets forth our revenue for the three and nine months ended September 30, 2006
and 2005 from each of our collaboration partners.
|
Three
months ended September 30,
|
Nine
months ended September 30,
|
|||||||||||
|
2006
|
2005
|
2006
|
2005
|
|||||||||
|
(in
thousands)
|
(in
thousands)
|
|||||||||||
J&J
PRD
|
$
|
-
|
$
|
358
|
$
|
-
|
$
|
1,060
|
|||||
Merck
|
237
|
1,328
|
6,124
|
3,969
|
|||||||||
|
237
|
1,686
|
6,124
|
5,029
|
|||||||||
Biogen
Idec-related party
|
1,712
|
1,637
|
5,592
|
6,881
|
|||||||||
Total
collaboration revenue
|
$
|
1,949
|
$
|
3,323
|
$
|
11,716
|
$
|
11,910
|
Collaboration
revenue decreased from $3.3 million for the three months ended September 30,
2005 to $1.9 million for the same period in 2006, primarily due to a
decrease in collaboration revenue from J&J PRD and Merck resulting from the
termination of the research phase of the Cathepsin S collaboration and the
BACE
collaboration, in December 2005 and February 2006, respectively. Collaboration
revenue decreased from $11.9 million for the first nine months of 2005 to $11.7
million for the same period in 2006 due to a decrease in collaboration revenue
from J&J PRD and Biogen Idec due to the completion of the research phase of
the collaboration with J&J PRD and the termination of the TNF-family
collaboration with Biogen Idec, partially offset by an increase in collaboration
revenue from Merck primarily related to the receipt of a $4.25 million milestone
payment in June 2006. We expect that revenue from reimbursed research services
will decrease for 2006 compared to prior years due to the completion of the
research phases of the Cathepsin S collaboration and the BACE collaboration.
Though the research phase of these collaborations has been completed, we will
continue to be eligible to earn milestone payments and royalties on any compound
that result from the collaborations.
Grant
and Fellowship Revenue.
Grant
and fellowship revenue is recognized as we perform services under the
applicable grant. As of September 30, 2006, we had been awarded
$5.4 million, and had recognized as revenue $3.2 million, in federal
grants under the Small Business Innovation Research (“SBIR”) program. In
addition, we have recognized revenue from other grants and fellowships. We
do
not plan to perform any additional work under our SBIR grants in the
foreseeable future.
Research
and Development Expense.
Most
of
our operating expenses to date have been for research and development
activities. Research and development expense represents costs incurred to
discover and develop novel, small molecule therapeutics, including Phase I
and
Phase II clinical trial costs for SNS-595, Phase I and Phase I/II clinical
trial
costs for SNS-032, to develop our proprietary fragment-based Tethering® drug
discovery approach, to develop in-house research and preclinical study
capabilities, to discover and advance product candidates toward clinical trials,
and to in-license compounds. We expense all research and development costs
as
they are incurred.
The
table
below sets forth our research and development expense for the three and nine
months ended September 30, 2006 and 2005 for our product candidate programs:
17
Three months ended September 30,
|
Nine months ended September 30,
|
||||||||||||
2006
|
2005
|
2006
|
2005
|
||||||||||
(in thousands)
|
(in thousands)
|
||||||||||||
SNS-595
|
$
|
2,217
|
$
|
1,558
|
$
|
6,117
|
$
|
4,570
|
|||||
SNS-032
|
961
|
676
|
4,420
|
8,939
|
|||||||||
SNS-314
|
1,297
|
1,819
|
3,880
|
5,224
|
|||||||||
Raf
kinase inhibitors
|
387
|
357
|
1,115
|
1,161
|
|||||||||
Other
kinase inhibitors
|
2,866
|
1,498
|
8,142
|
4,133
|
|||||||||
Cathepsin
S inhibitors
|
-
|
233
|
7
|
554
|
|||||||||
BACE
inhibitors for Alzheimer’s disease
|
1
|
399
|
315
|
1,290
|
|||||||||
Anti-viral
inhibitors
|
-
|
-
|
-
|
37
|
|||||||||
TNF-family
and oncology research
|
-
|
14
|
3
|
950
|
|||||||||
Other
programs
|
854
|
317
|
3,148
|
1,406
|
|||||||||
Total
|
$
|
8,583
|
$
|
6,871
|
$
|
27,147
|
$
|
28,264
|
Research
and development expense increased from $6.9 million for the three months ended
September 30, 2005 to $8.6 million for the same period in 2006, due to (i)
a
$1.4 million increase in spending on undisclosed kinase inhibitors in our
discovery pipeline, (ii) a $944,000 increase in spending on our clinical stage
programs SNS-595 and SNS-032, and (iii) a $537,000 increase in spending on
other
discovery programs including the expansion of our monophore library used for
Tethering® experiments. These increases were partially offset by (i) a $522,000
decreased expense for our SNS-314 program due to the completion of the medicinal
chemistry work on this program in 2005, and (ii) a $398,000 reduction in expense
related to the completion of the research phases of the BACE collaboration
with
Merck.
Research
and development expense decreased from $28.3 million for the nine months ended
September 30, 2005 to $27.1 million for the same period in 2006 due to (i)
a
$8.0 million non-cash license fee paid to BMS in April 2005, (ii) a $1.3 million
reduction in expense for SNS-314, (iii) a $975,000 reduction in expense related
to the completion of the research phases of the BACE collaboration with Merck,
and (iv) a $947,000 reduction in expense related to the completion of the
TNF-family collaboration with Biogen Idec. These expense reductions were
partially offset by (i) a $2.0 million non-cash milestone payment to BMS in
March 2006 and a $1.5 million increase in expense related to running of a Phase
I/ II clinical trial with SNS-032, (ii) a $4.0 million increase in expense
related to other kinase inhibitors as a result of an increase in headcount
focused on the discovery of novel kinase inhibitors, and (iii) a $1.5 million
increase in expense related to the development of SNS-595.
We
expect
to incur a significant increase in research and development expense over the
next several years, only a portion of which we expect to be funded by our
collaboration partners. As SNS-595 and SNS-032 progress through the clinical
development stage and we bring additional product candidates, such as SNS-314,
into clinical trials, our spending will further increase. In addition, under
our
August 2004 collaboration with Biogen Idec, we have an option to co-fund a
portion of the development costs of product candidates for up to two targets
that may result from this collaboration. Our decision to exercise this
option would materially increase our research and development
expense.
General
and Administrative Expense. Our
general and administrative expense consists primarily of salaries and other
related costs for personnel in finance, human resources, facilities, management,
legal, including intellectual property management, and general administration
and non-cash stock compensation. Other significant costs include facilities
costs and fees paid to outside legal advisors and auditors. General and
administrative expense was $2.1 million and $3.0 million for the three months
ended September 30, 2005 and 2006, respectively. This $980,000 increase is
due
to (i) a $278,000 increase in payroll and related expenses, including a $168,000
increase in non-cash stock-based compensation expense due to our adoption of
FAS
123R in 2006, and (ii) a $343,000 increase in professional service expense,
including expenses related to our intellectual property portfolio, and increased
costs related to operating as a public company. General and administrative
expense increased from $6.1 million for the first nine months of 2005 to $8.9
million for the same period in 2006. This $2.8 million increase is primarily
due
to (i) a $907,000 increase in payroll and related expenses, including a $585,000
increase in non-cash stock-based compensation expense, (ii) a $883,000 increase
in professional service expense, including expenses related to our intellectual
property portfolio, and increased costs related to operating as a public
company.
As
a
public company, we operate in an increasingly demanding regulatory environment
that requires us to comply with the Sarbanes-Oxley Act of 2002 and the related
rules and regulations of the SEC and the Nasdaq Global Market, including
those related to expanded disclosures, accelerated reporting requirements and
more complex accounting rules. We expect that our general and administrative
expense will continue to increase in subsequent periods due to these
requirements and to increasing personnel and infrastructure expenses as we
advance our product candidates.
18
Interest
Income.
Interest
income increased from $179,000 and $574,000 for the three and nine months ended
September 30, 2005, respectively, to $992,000 and $2.5 million for the three
and
nine months ended September 30, 2006, respectively, primarily due to higher
interest rates and higher average balances of cash, cash equivalents and
marketable securities.
Interest
Expense.
Interest
expense decreased from $229,000 for the three months ended September 30, 2005
to
$46,000 for the same period in 2006 due to lower outstanding debt obligations
in
2006. Interest expense decreased from $446,000 for the nine months ended
September 30, 2005 to $434,000 for the same period in 2006 due to lower
outstanding debt obligations in 2006.
Liquidity
and Capital Resources
As
of
September 30, 2006, we had cash, cash equivalents and marketable securities
of
$71.2 million and outstanding equipment financing and debt obligations of
$1.7 million. In March 2006, we raised net proceeds of $43.7 million
through a private placement of 7,246,377 shares of common stock and warrants
to
purchase an additional 2,173,914 shares of common stock (“2006 PIPE Financing”).
The purchase price for the common stock and the exercise price for the warrants
is $6.21 per share. Investors in the financing paid an additional purchase
price
equal to $0.125 for each share of common stock underlying the warrants. The
SEC
issued an order declaring the registration statement for the 2006 PIPE Financing
effective on May 10, 2006. Since our inception, we have funded our operations
primarily through the issuance of common and preferred stock, research funding
and technology access fees from our collaboration partners, research grants
and
debt financings.
Cash
Flow
Net
cash
used in operating activities was $15.5 million and $19.0 million for the
nine months ended September 30, 2005 and 2006, respectively. Net cash used
in
operating activities for these periods consisted primarily of our net loss,
partially offset by depreciation and amortization, deferred
revenue and stock compensation expense. The nine-month periods ended September
30, 2005 and 2006 included $8.0 million and $2.0 million of non-cash payments
to
BMS, respectively.
Net
cash
provided by investing activities was $18.2 million for the nine months ended
September 30, 2005 and net cash used by investing activities was $14.8 million
for the nine months ended September 30, 2006 . The cash provided during the
nine
months ended September 30, 2005 was primarily attributable to the net maturities
of $19.5 million of securities, partially offset by the purchase of property
and
equipment totaling $1.3 million. Net cash used during the nine months ended
September 30, 2006 was related to the net purchase of $12.9 million of
securities, and the purchase of property and equipment of $1.9 million. Our
investing activities for these periods consisted primarily of the management
of
proceeds from our sales of common and preferred stock.
Net
cash
provided by financing activities was $34.9 million and $43.8 million for
the nine months ended September 30, 2005 and 2006, respectively. Our financing
activities for the 2005 period consisted primarily of the IPO
in
September 2005 and the repayment of borrowings from Biogen Idec, a related
party, also in September 2005. Our financing activities through the third
quarter of 2006 have consisted primarily of the 2006 PIPE Financing pursuant
to
which we issued 7,246,377 shares of common stock and warrants to purchase an
additional 2,173,914 shares of common stock for net proceeds of $43.7 million
in
a private placement which closed in March 2006.
Credit
and Loan Arrangements
In
June 2000, we entered into an equipment financing agreement with General
Electric Capital Corporation, which has been amended from time to time. The
credit facility was available through May 2005. In August 2005, we
entered into a new $2.5 million credit facility with General Electric
Capital Corporation. As of September 30, 2006, we had outstanding
$1.7 million to finance equipment purchases and leasehold improvements
under both credit facilities. The equipment loans are secured by the equipment
financed. Outstanding borrowings bear interest at annual rates ranging from
7.4%
to 10.6%, and are payable over 36 to 48 months. In connection with the
original credit facility, in May 2003, we issued a warrant to purchase
1,582 shares of common stock at $9.10 per share, and in June 2004, a
warrant to purchase 757 shares of common stock at $9.10 per share. The warrants
expire in June 2013 and June 2014, respectively. In connection with
the new credit facility in August 2005, we issued warrants to purchase up
1,046 shares of common stock at $9.10 per share.
In
December 2002, we executed a promissory note in favor of Biogen Idec for an
aggregate principal amount of up to $4.0 million. Under the promissory
note, we had a drawdown period of ten calendar quarters beginning on
April 1, 2003 and ending on June 30, 2005. The principal and accrued
interest of each draw are due five years from the date of advance of each draw
and bear interest at 3.0% above LIBOR to be paid quarterly. As of June 30,
2005,
we had drawn $4.0 million; however, the full $4.0 million was repaid with
interest on September 30, 2005 with the proceeds from our IPO.
In
August 2005, we entered into a Venture Loan and Security Agreement with
Oxford Finance Corporation and Horizon Technology Funding Company LLC, pursuant
to which we may borrow up to $15.0 million. The full
$15.0 million loan commitment was available until October 15, 2005;
$10.0 million was available until January 31, 2006 and the remaining
$5.0 million was available until May 31, 2006. This facility expired
on May 31, 2006, and the Company had not drawn any amount under this facility.
In conjunction with this transaction, we issued warrants to the lenders to
purchase an aggregate of up to 164,830 shares of common stock at a price of
$9.10 per share. We
also
granted the lenders registration rights under our Eighth Amended and Restated
Investor Rights Agreement.
19
Operating
Capital and Capital Expenditure Requirements
We
expect
to continue to incur substantial operating losses in the future. We will not
receive any product revenue until a product candidate has been approved by
the
FDA or similar regulatory agencies in other countries and successfully
commercialized. We currently anticipate that our cash, cash equivalents,
marketable securities and available credit facilities, together with the
proceeds from the IPO and the 2006 PIPE Financing and revenue generated from
our
collaborations, will be sufficient to fund our operations at least through
April 2008. However, we will need to raise substantial additional funds to
continue our operations and bring future products to market. We cannot be
certain that any of our programs will be successful or that we will be able
to
raise sufficient funds to complete the development and commercialization of
any
of our product candidates currently in development, should they succeed.
Additionally, we plan to continue to evaluate in-licensing and acquisition
opportunities to gain access to new drugs or drug targets that would fit with
our strategy. Any such transaction would likely increase our funding needs
in
the future.
Our
future funding requirements will depend on many factors, including but not
limited to:
•
|
the
rate of progress and cost of our clinical trials, preclinical studies
and
other discovery and research and development
activities;
|
•
|
the
costs associated with establishing manufacturing and commercialization
capabilities;
|
•
|
the
costs of acquiring or investing in businesses, product candidates
and
technologies;
|
•
|
the
costs of filing, prosecuting, defending and enforcing any patent
claims
and other intellectual property
rights;
|
•
|
the
costs and timing of seeking and obtaining FDA and other regulatory
approvals;
|
•
|
the
effect of competing technological and market developments;
and
|
•
|
the
economic and other terms and timing of any collaboration, licensing
or
other arrangements into which we
may enter.
|
Until
we
can generate a sufficient amount of product revenue to finance our cash
requirements, which we may never do, we expect to finance future cash needs
primarily through public or private equity offerings, debt financings or
strategic collaborations. We do not know whether additional funding will be
available on acceptable terms, or at all. If we are not able to secure
additional funding when needed, we may have to delay, reduce the scope of
or eliminate one or more of our clinical trials or research and development
programs. In addition, we may have to partner one or more of our product
candidate programs at an earlier stage of development, which would lower the
economic value of those programs to our company.
We
are
not subject to any meaningful market risks related to currency, commodity prices
or similar matters. We are sensitive to short-term interest rate fluctuations
to
the extent that such fluctuations impact the interest income we receive on
the
investment of the proceeds from our IPO wherein we raised approximately $37.2
million and our 2006 PIPE Financing, wherein we raised net proceeds of $43.7
million.
The
primary objective of our investment activities is to preserve principal while
at
the same time maximizing the income we receive from our investments without
significantly increasing risk. Some of the securities that we invest in
may have market risk. This means that a change in prevailing interest rates
may cause the principal amount of the investment to fluctuate. For example,
if we hold a security that was issued with a fixed interest rate at the
then-prevailing rate and the prevailing interest rate later rises, the fair
value of our investment will probably decline. To minimize this risk in the
future, we intend to maintain our portfolio of cash equivalents and short-term
investments in a variety of securities, including money market funds, commercial
paper and government and non-government debt securities. For 2005 and the first
nine months of 2006, we maintained an investment portfolio primarily in money
market funds and corporate commercial paper. Due to the short-term nature of
the
majority of these investments, we believe we do not have a material exposure
to
interest risk arising from our investments.
All
of
our revenue, expense, and capital purchasing activities are transacted in U.S.
dollars.
20
Item
4. Controls and Procedures
Conclusion
Regarding the Effectiveness of Disclosure Controls and
Procedures
We
maintain disclosure controls and procedures, as such term is defined in SEC
Rule 13a-15(e), that are designed to ensure that information required to be
disclosed in our Securities Exchange Act of 1934 reports is recorded, processed,
summarized and reported within the time periods specified in the SEC’s
rules and forms and that such information is accumulated and communicated
to our management, including our Chief Executive Officer and Chief Financial
Officer, as appropriate, to allow for timely decisions regarding required
disclosure. In designing and evaluating the disclosure controls and procedures,
management recognizes that any controls and procedures, no matter how well
designed and operated, can provide only reasonable assurance of achieving the
desired control objectives, and management is required to apply its judgment
in
evaluating the cost-benefit relationship of possible controls and
procedures.
As
required by SEC Rule 13a-15(b), we carried out an evaluation, under the
supervision and with the participation of our management, including our Chief
Executive Officer and Chief Financial Officer, of the effectiveness of the
design and operation of our disclosure controls and procedures as of the end
of
the period covered by this report. Based on the foregoing, our Chief Executive
Officer and Chief Financial Officer concluded that our disclosure controls
and
procedures were effective at the reasonable assurance level.
Our
Annual Report on Form 10-K for the year ended December 31, 2005
includes a detailed discussion of our risk factors. The information presented
below provides material changes to and should be read in conjunction with the
risk factors and information disclosed in that Form 10-K.
We
are encountering a delay in enrolling patients in our clinical trial of SNS-595
in patients with non-small cell lung cancer.
Patient
enrollment depends on many factors, including, the size of the patient
population, the nature and complexity of the protocol, the proximity of patients
to clinical sites and the eligibility criteria for the trial. Our product
candidates are focused in oncology, which can be a difficult patient population
to recruit. Without exception, oncology patients have failed treatment in first
and second line treatment before enrolling in a study of an investigations
product candidate.
We
are
encountering a delay in enrolling patients for our clinical trial of SNS-595
in
patients with non-small cell lung cancer from our projected enrollment rates.
This may result in a delay in our projected timeline for development of SNS-595,
and also may lead to increased costs in developing this product candidate for
this indication.
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,” (“FAS 123R”). As a result of adopting FAS
123R on January 1, 2006, the Company’s loss for the three and nine months
ended September 30, 2006 is $472,581 and $1,300,335 larger, respectively, than
if it had continued to account for share-based compensation under APB 25. Basic
and diluted loss per share for the quarter ended September 30, 2006 are $0.30
and $0.02 lower, respectively, than if the Company had continued to account
for
share-based compensation under APB 25. Basic and diluted loss per share for
the
nine months ended September 30, 2006 are $0.82 and $0.05 lower, respectively,
than if the Company had continued to account for share-based compensation under
APB 25.
Future
employee stock-based compensation expense is difficult to quantify as it is
affected by our stock price, the number of stock-based awards our Board of
Directors may grant, as well as a number of complex and subjective valuation
assumptions and the related tax effect. These valuation assumptions include,
but
are not limited to, the volatility of our stock price and employee stock option
exercise behaviors.
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds
The
initial public offering of 6,051,126 shares of our common stock was effected
through a registration statement on Form S-1 (Reg. No. 333-121646) which was
declared effective by the SEC on September 27, 2005. We issued 6,000,000 shares
on September 30, 2005 for gross proceeds of $42,000,000. We issued an additional
51,126 shares on November 1, 2005 for gross proceeds of $358,000 in connection
with the underwriters’ partial exercise of their over-allotment option. We paid
the underwriters a commission of $2,965,000 and incurred additional offering
expenses of approximately $2,225,000. After deducting the underwriters’
commission and the offering expenses, the registrant received net proceeds
of
approximately $37,168,000.
21
In
our
2006 PIPE Financing during the quarter ended March 31, 2006, we sold an
aggregate of 7,246,377 shares of common stock and warrants to purchase up to
2,173,914 additional shares of common stock to certain accredited investors
for
cash consideration in the aggregate amount of approximately $45.3 million.
The
purchase price of the common stock and the exercise price for the warrants
is
$6.21 per share. Investors in the financing paid an additional purchase price
equal to $0.125 for each share of common stock underlying the warrants. The
shares sold in the 2006 PIPE Financing have subsequently been registered on
a
registration statement on Form S-1 (Reg. No. 333-133387) which was declared
effective by the SEC on May 10, 2006.
The
net
proceeds from these offerings have been invested into short-term investment
grade securities and money market accounts. We have begun, and intend to
continue to use, our net proceeds to fund clinical and preclinical development
of our product candidates, to discover additional product candidates, to repay
outstanding indebtedness and for general corporate purposes, including capital
expenditures and working capital. We may use a portion of our net proceeds
to
in-license product candidates or to invest in businesses or technologies that
we
believe are complementary to our own.
On
September 13, 2006, our Board of Directors approved a change of date for the
determination of the fair market value for equity compensation grants issued
to
employees under the 2005 Equity Incentive Award Plan (“2005 Plan”), the 2006
Employment Commencement Incentive Plan (“2006 Plan”) and the Employee Stock
Purchase Plan (“ESPP”)(collectively, the “Plans”). Previously, each of the Plans
defined “Fair Market Value” as the closing sales price for our securities (or
the closing bid, if no sales were reported) as quoted on such exchange or system
for the last market trading day prior to the date of determination, as reported
in The
Wall Street Journal
or such
other source deemed reliable. Going forward, the Plans are revised to change
the
definition of “Fair Market Value” to be the closing market price of the
securities on the date of grant which date shall be the date of determination,
as reported in The
Wall Street Journal
or such
other source as deemed reliable.
Item
6. Exhibits
Exhibit
Number
|
Description
|
|
10.3
|
2005
Equity Incentive Award Plan and Form of Stock Option
Agreement.
|
|
10.4
|
Employee
Stock Purchase Plan and Enrollment Form.
|
|
10.43
|
2006
Employment Incentive Commencement Plan.
|
|
31.1
|
Certification
of Chief Executive Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
31.2
|
Certification
of Chief Financial Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
32.1
|
Certification
of Chief Executive Officer pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
|
|
32.2
|
Certification
of Chief Financial Officer pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
|
22
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant
has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
SUNESIS
PHARMACEUTICALS, INC.
|
||
(Registrant)
|
||
|
|
|
By: |
/s/
ERIC H. BJERKHOLT
|
|
Eric
H. Bjerkholt
|
||
Senior
Vice President and Chief Financial
Officer
|
Date:
November 9, 2006
23
EXHIBIT INDEX
Exhibit
Number
|
Description
|
|
10.3
|
2005
Equity Incentive Award Plan and Form of Stock Option
Agreement.
|
|
10.4
|
Employee
Stock Purchase Plan and Enrollment Form.
|
|
10.43
|
2006
Employment Incentive Commencement Plan.
|
|
31.1
|
Certification
of Chief Executive Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
31.2
|
Certification
of Chief Financial Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
32.1
|
Certification
of Chief Executive Officer pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
|
|
32.2
|
Certification
of Chief Financial Officer pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
|
24