Viracta Therapeutics, Inc. - Quarter Report: 2007 March (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 March 31, 2007
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 x Non-Accelerated
Filer
o
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 29,481,964 shares of Common Stock, $0.0001 par value per share,
outstanding as of April 30, 2007.
Sunesis
Pharmaceuticals, Inc.
TABLE
OF CONTENTS
Page
No.
|
||||
PART I.
FINANCIAL INFORMATION
|
||||
Item
1.
|
Financial
Statements:
|
|||
Condensed
Balance Sheets as of March 31, 2007 and December 31,
2006
|
2
|
|||
Condensed
Statements of Operations for the Three Months Ended March 31, 2007
and
2006
|
3
|
|||
Condensed
Statements of Cash Flows for the Three Months Ended March 31, 2007
and
2006
|
4
|
|||
Notes
to Condensed Financial Statements
|
5
|
|||
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of Operations
|
15 | ||
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
19 | ||
Item
4.
|
Controls
and Procedures
|
19 | ||
PART II.
OTHER INFORMATION
|
||||
Item
1A.
|
Risk
Factors
|
20 | ||
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
20 | ||
Item
5.
|
Other
Information
|
20 | ||
Item
6.
|
Exhibits
|
20 | ||
Signature
|
22 |
SUNESIS
PHARMACEUTICALS, INC.
March
31,
|
December 31,
|
||||||
2007
|
2006
|
||||||
(Unaudited)
|
(Note 1)
|
||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
11,005,836
|
$
|
6,075,449
|
|||
Marketable
securities
|
42,117,157
|
57,029,199
|
|||||
Prepaids
and other current assets
|
1,468,314
|
1,082,817
|
|||||
Total
current assets
|
54,591,307
|
64,187,465
|
|||||
Property
and equipment, net
|
4,824,551
|
4,728,929
|
|||||
Deposits
and other assets
|
359,974
|
359,974
|
|||||
Total
assets
|
$
|
59,775,832
|
$
|
69,276,368
|
|||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
1,731,885
|
$
|
2,477,656
|
|||
Accrued
compensation
|
1,609,254
|
2,323,742
|
|||||
Other
accrued liabilities
|
2,016,851
|
961,766
|
|||||
Current
portion of deferred revenue
|
2,031,311
|
2,260,478
|
|||||
Current
portion of equipment financing
|
862,088
|
885,273
|
|||||
Total
current liabilities
|
8,251,389
|
8,908,915
|
|||||
Non
current portion of deferred revenue
|
705,660
|
1,143,159
|
|||||
Non
current portion of equipment financing
|
977,131
|
955,695
|
|||||
Deferred
rent and other non-current liabilities
|
1,478,813
|
1,464,902
|
|||||
Commitments
|
|||||||
Stockholders’
equity:
|
|||||||
Preferred
stock, $0.0001 par value; 5,000,000 shares authorized, no shares
issued
and outstanding at March 31, 2007 and December 31, 2006
|
—
|
—
|
|||||
Common
stock, $0.0001 par value; 100,000,000 shares authorized,
29,473,297 shares issued and outstanding at March 31, 2007;
100,000,000 shares authorized, 29,443,079 shares issued and
outstanding at December 31, 2006
|
2,947
|
2,944
|
|||||
Additional
paid-in capital
|
298,822,087
|
298,073,896
|
|||||
Deferred
stock-based compensation
|
(834,123
|
)
|
(1,006,604
|
)
|
|||
Accumulated
other comprehensive loss
|
(13,872
|
)
|
(21,376
|
)
|
|||
Accumulated
deficit
|
(249,614,200
|
)
|
(240,245,163
|
)
|
|||
Total
stockholders’ equity
|
48,362,839
|
56,803,697
|
|||||
Total
liabilities and stockholders’ equity
|
$
|
59,775,832
|
$
|
69,276,368
|
Note 1: |
The
condensed balance sheet at December 31, 2006 has been derived from
the audited financial statements at that date included in the Company’s
Form 10-K for the fiscal year ended December 31,
2006.
|
See
accompanying notes to financial statements.
2
SUNESIS
PHARMACEUTICALS, INC.
Three months ended March
31,
|
|||||||
2007
|
2006
|
||||||
(unaudited)
|
|||||||
Revenue:
|
|||||||
Collaboration
revenue
|
$
|
229,167
|
$
|
1,370,705
|
|||
Collaboration
revenue from related party
|
2,037,099
|
1,688,859
|
|||||
License
revenue
|
250,000
|
—
|
|||||
Grant
and fellowship revenue
|
—
|
37,901
|
|||||
Total
revenues
|
2,516,266
|
3,097,465
|
|||||
Operating
expenses:
|
|||||||
Research
and development
|
9,307,478
|
9,716,095
|
|||||
General
and administrative
|
3,296,147
|
2,681,571
|
|||||
Total
operating expenses
|
12,603,625
|
12,397,666
|
|||||
Loss
from operations
|
(10,087,359
|
)
|
(9,300,201
|
)
|
|||
Interest
income
|
769,626
|
546,153
|
|||||
Interest
expense
|
(52,043
|
)
|
(225,552
|
)
|
|||
Other
income, net
|
739
|
1,890
|
|||||
Net
loss
|
$
|
(9,369,037
|
)
|
$
|
(8,977,710
|
)
|
|
Basic
and diluted loss per share
|
$
|
(0.32
|
)
|
$
|
(0.39
|
)
|
|
Shares
used in computing basic and diluted loss per share
|
29,457,247
|
22,968,484
|
See
accompanying notes to financial statements.
3
SUNESIS
PHARMACEUTICALS, INC.
Three months ended March
31,
|
|||||||
2007
|
2006
|
||||||
(Unaudited)
|
|||||||
Cash
flows from operating activities
|
|||||||
Net
loss
|
$
|
(9,369,037
|
)
|
$
|
(8,977,710
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
Depreciation
and amortization
|
427,892
|
386,623
|
|||||
Stock-based
compensation expense
|
848,203
|
684,297
|
|||||
Non-cash
research and development expense
|
—
|
1,999,999
|
|||||
Changes
in operating assets and liabilities:
|
|||||||
Prepaids
and other current assets
|
(385,497
|
)
|
331,562
|
||||
Accounts
payable
|
(745,771
|
)
|
(185,036
|
)
|
|||
Accrued
compensation
|
(714,488
|
)
|
(634,359
|
)
|
|||
Other
accrued liabilities
|
1,055,085
|
(321,399
|
)
|
||||
Deferred
rent and other non-current liabilities
|
13,911
|
31,746
|
|||||
Deferred
revenue
|
(666,666
|
)
|
(1,808,204
|
)
|
|||
Net
cash used in operating activities
|
(9,536,368
|
)
|
(8,492,481
|
)
|
|||
Cash
flows from investing activities
|
|||||||
Purchases
of property and equipment
|
(523,514
|
)
|
(1,038,084
|
)
|
|||
Purchases
of marketable securities
|
(17,017,531
|
)
|
(3,925,280
|
)
|
|||
Maturities
of marketable securities
|
31,937,077
|
8,575,987
|
|||||
Net
cash provided by investing activities
|
14,396,032
|
3,612,623
|
|||||
Cash
flows from financing activities
|
|||||||
Proceeds
from borrowings under equipment financing
|
252,533
|
—
|
|||||
Payments
on equipment financing
|
(254,282
|
)
|
(341,331
|
)
|
|||
Proceeds
from issuance of common stock and exercise of options, net of
repurchases
|
72,472
|
43,824,455
|
|||||
Net
cash provided by financing activities
|
70,723
|
43,483,124
|
|||||
Net
increase in cash and cash equivalents
|
4,930,387
|
38,603,266
|
|||||
Cash
and cash equivalents at beginning of period
|
6,075,449
|
17,704,465
|
|||||
Cash
and cash equivalents at end of period
|
$
|
11,005,836
|
$
|
56,307,731
|
|||
Supplemental
disclosure of cash flow information
|
|||||||
Interest
paid
|
$
|
52,043
|
$
|
75,163
|
|||
Non-cash
activities:
|
|||||||
Deferred
stock-based compensation, net of (reversal)
|
$
|
(2,533
|
)
|
$
|
(352,638
|
)
|
|
Issuance
of common stock for in-licensing agreement
|
$
|
—
|
$
|
1,999,999
|
See
accompanying notes to financial statements.
4
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. In January 2007, the
Company formed a wholly-owned subsidiary, Sunesis Europe Limited, a United
Kingdom corporation.
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 U. S. 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, 2006 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 or any other
interim period.
These
unaudited, condensed financial statements and the notes accompanying them should
be read in conjunction with the Company’s Annual Report on Form 10-K for
the year ended December 31, 2006.
Loss
Per Share
Basic
loss per share is calculated by dividing the net 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 net 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,
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.
5
The
following table sets forth the computation of basic and diluted loss per common
share:
Three months ended March
31,
|
|||||||
2007
|
2006
|
||||||
Numerator:
|
|||||||
Net
loss
|
$
|
(9,369,037
|
)
|
$
|
(8,977,710
|
)
|
|
Denominator:
|
|||||||
Weighted-average
common shares outstanding
|
29,457,247
|
22,968,484
|
|||||
Less:
Weighted-average unvested common shares subject to
repurchase
|
—
|
—
|
|||||
Denominator
for basic and diluted loss per share applicable to common
stockholders
|
29,457,247
|
22,968,484
|
|||||
Basic
and diluted loss per share applicable to common
stockholders
|
$
|
(0.32
|
)
|
$
|
(0.39
|
)
|
|
Outstanding
securities not included in diluted loss per share
calculation:
|
|||||||
Options
to purchase common stock
|
3,965,988
|
2,937,830
|
|||||
Warrants
|
2,693,237
|
2,700,296
|
|||||
6,659,225
|
5,638,126
|
Comprehensive
Loss
Comprehensive
loss is comprised of net loss and other comprehensive income (loss). The Company
includes in other comprehensive income (loss) unrealized gains and losses
on marketable securities. Comprehensive loss is as follows:
Three months ended March
31,
|
|||||||
2007
|
2006
|
||||||
Net
loss
|
$
|
(9,369,037
|
)
|
$
|
(8,977,710
|
)
|
|
Change
in unrealized gain on marketable securities
|
7,504
|
27,013
|
|||||
Comprehensive
loss
|
$
|
(9,361,533
|
)
|
$
|
(8,950,697
|
)
|
Accumulated
other comprehensive loss consists of the following:
March
31,
|
December 31,
|
||||||
2007
|
2006
|
||||||
Unrealized
holding loss on marketable securities
|
$
|
(13,872
|
)
|
$
|
(21,376
|
)
|
6
Employee
Stock-Based Compensation
On
January 1, 2006, the Company adopted Statement of Financial Accounting
Standards No. 123 (revised 2004), “Share-Based Payment” (“FAS 123R”).
FAS
123R
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
March 31,
|
|||||||
2007
|
2006
|
||||||
Research
and development
|
$
|
364,893
|
$
|
283,638
|
|||
General
and administrative
|
481,691
|
336,364
|
|||||
Stock-based
compensation
|
$
|
846,584
|
$
|
620,002
|
Valuation
Assumptions
We
use
the Black-Scholes option-pricing model (“Black-Scholes model”) to value our
stock options with the following assumptions (annualized
percentages):
Three months ended March
31,
|
|||||||
2007
|
2006
|
||||||
Volatility
|
68.50
|
%
|
80.00
|
%
|
|||
Risk-free
interest rate
|
4.66
|
%
|
4.63
|
%
|
|||
Dividend
yield
|
0.00
|
%
|
0.00
|
%
|
|||
Expected
term (years)
|
5.06
|
5.00
|
The
weighted-average estimated fair value of employee stock options granted during
the three months ended March 31, 2007 and 2006 was $2.68 and $4.36 per
share, respectively, using the Black-Scholes model. The Company recorded
$3,000
and $1,000, respectively, in stock-based compensation expense during the
three
months ended March 31, 2007 and 2006, respectively, related to stock-based
awards granted during the first three months of 2007 and 2006,
respectively.
The
weighted average estimated fair value of purchase rights under our Employee
Stock Purchase Plan (“ESPP”) for the three months ended March 31, 2007 and 2006
was $2.03 and $2.95 per share, respectively, using the Black-Scholes model
with
the following assumptions:
Three months ended
March 31,
|
|||||||
2007
|
2006
|
||||||
Volatility
|
80.00
|
%
|
80.00
|
%
|
|||
Risk-free
interest rate
|
4.87
- 5.06
|
%
|
4.00
|
%
|
|||
Dividend
yield
|
0.00
|
%
|
0.00
|
%
|
|||
Expected
term (years)
|
0.5
- 1.0
|
0.5
- 1.0
|
The
Company has based its assumptions for volatility and expected term of employee
stock options on the information available with respect to its peer group
in the
same industry. The expected term of the employees’ purchase rights is equal to
the purchase period. 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.
7
Stock-based
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-based 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 -based
compensation is being amortized over the related vesting terms of the options.
The Company recorded amortization of deferred stock-based compensation of
$0.17
million and $0.19 million, respectively, in the three months ended March
31,
2007 and 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 $0.3 million was reversed as
of
January 1, 2006 due to the adoption of FAS 123R.
As
of
March 31, 2007, the expected future amortization expense for deferred
stock-based compensation during each of the following periods is as
follows:
Year ending December 31,
|
||||
2007
remaining period
|
$
|
508,019
|
||
2008
|
326,104
|
|||
Total
amount to be amortized
|
$
|
834,123
|
Accounting
for Uncertainty in Income Taxes
On
January 1, 2007, the Company adopted the provisions of Financial Standards
Accounting Board Interpretation No. 48, “Accounting for Uncertainty in Income
Taxes-an interpretation of FASB Statement No. 109” (“FIN 48”). There was no
impact on the Company’s financial statements upon adoption. Because of Company’s
historical net operating losses, it have not been subject to income tax since
inception. There were no unrecognized tax benefits during all the periods
presented.
We
maintain deferred tax assets that reflect the net tax effects of temporary
differences between the carrying amounts of assets and liabilities for financial
reporting purposes and the amounts used for income tax purposes. These deferred
tax assets include net operating loss carryforwards, research credits and
capitalized research and development. The net deferred tax asset has been fully
offset by a valuation allowance because of the Company’s history of losses.
Utilization of operating losses and credits may be subject to substantial annual
limitation due to ownership change provisions of the Internal Revenue Code
of
1986 and similar state provisions. The annual limitation may result in the
expiration of net operating losses and credits before utilization.
The
Regents of the University of California
In
December 1998, the Company entered into an exclusive license agreement with
The Regents of the University of California (the “Regents”) for rights to
certain technology to identify small molecule drug leads. The agreement provides
the Company with an exclusive license to develop, make, use, and sell products
derived from the licensed technology, and will continue for the life of the
last-to-expire patent. To date, the licensed technology has produced two issued
patents, U.S. patent Nos. 6,344,330 and 6,344,334, which are both due to
expire on March 27, 2018. Because the Company no longer uses the licensed
technology, none of the Company’s preclinical or clinical compound originates
from the licensed technology. The Company has not received written notice from
the Regents to terminate or amend the agreement and the Company continues to
provide the Regents status reports of the state of the licensed technology.
The
Company also continues to maintain patents and patent applications that cover
the licensed technology because of its belief that some aspects of the licensed
technology may provide some value in the future.
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.
8
In
addition to payments already made as of December 31, 2006, 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. As of December 31, 2005, the Company accrued a
$0.5 million milestone payment upon commencement of Phase 2 clinical
trials as research and development expense. 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 445,663 shares of the Company’s
Series C-2 preferred stock, which converted into 879,094 shares of
common stock upon the Company’s IPO in September 2005. 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 be required to 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 be required to 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 net sales. In return, the Company
received worldwide exclusive and non-exclusive diagnostic and therapeutic
licenses to SNS-032 and future CDK inhibitors derived from related intellectual
property. In February 2006, upon commencement of a Phase 1 clinical
trial, the Company made a $2.0 million milestone payment through the
issuance of 404,040 shares of the Company’s common stock, which was
recorded as R&D expense.
The
University of California, San Francisco
In
August 2005, and amended in April 2006, the Company entered into
research and license agreements with the University of California, San Francisco
(“ UCSF”), that allows UCSF a limited license to use Tethering® for academic
purposes. UCSF intends to leverage Tethering® to identify novel, small molecule
drug candidates. In return, the Company received an exclusive royalty-free
license to any improvements to Tethering® or fragment libraries that emerge from
UCSF’s research. In the event that any small molecules are discovered using
Tethering®, the Company will have a right of first negotiation to in-license the
compounds. UCSF is precluded from utilizing the technology for commercial
purposes and from conducting research in the kinase field or any other drug
target on which the Company is currently interested. The research at UCSF is
being conducted by Dr. James Wells. Dr. Wells was a founder of our
company and is a member of our board of directors.
SARcode, Inc.
In
March 2006, and amended in December 2006, the Company entered into a
license agreement with SARcode, Inc. (“SARcode”), a privately-held
biopharmaceutical company, that provides SARcode an exclusive, worldwide license
to all of the Company’s LFA-1 patents and related know-how. SARcode intends to
use the license to develop small molecule drugs to treat inflammatory diseases.
The Company had previously discontinued the LFA-1 inhibitor program, which
is
outside of the Company’s strategic focus on discovering and developing novel
small molecule therapeutics to treat cancer.
Pursuant
to the license agreement, in January 2007 the Company received a $0.25
million license fee, which was recorded as revenue, and a $0.25 million note
convertible into preferred stock of SARcode in certain circumstances. The
Company did not record the $0.25 million note receivable from SARcode which
is
due in 2012 due to uncertainty of collectibility. In addition to cash and
convertible note already received, the Company may receive up to $1.0 million
in
license fees and convertible notes, $31.0 million in development and marketing
milestone payments, and royalties for the commercialization of a licensed
compound.
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.
9
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 the 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 $0.25
million 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 the
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 the collaboration to extend the research funding
from May 3, 2005 until December 31, 2005. The research funding portion
of the agreement expired on 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 is 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
$0.36 million 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 this
agreement was completed. Accordingly, the remaining deferred revenue of $0.82
million was recognized in the second quarter of 2005.
Concurrent
with the signing of the agreement, Biogen Idec made a $6.0 million equity
investment and purchased shares of the Company’s Series C-1 preferred
stock. Biogen Idec had also agreed to loan the Company up to $4.0 million with
a
drawdown period of ten calendar quarters beginning on January 1, 2003
and ending on June 30, 2005. The principal and accrued interest of each
draw is due five years from the date of advance of each draw and bear interest
at three percent above LIBOR (LIBOR was 1.46% at December 31, 2003, and
3.10% at December 31, 2004) to be paid quarterly. As of
December 31, 2003 and 2004 and September 30, 2005, the Company had
drawn $1.6 million, $3.2 million and $4.0 million, respectively, with $2.4
million, $0.8 million and none, respectively, available for future draws. On
September 30, 2005, this loan was repaid in full with
interest.
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 nonrefundable and noncreditable 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
is entitled to pay to the Company an additional technology access fee specified
in the agreement. In addition, the Company is obligated to receive quarterly
research funding of $1.2 million, subject to inflation adjustments, 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. In April 2006, the Company received a $0.5 million milestone
payment from Biogen Idec for meeting certain preclinical milestone related
to
Raf program, and the Company recorded it as revenue.
Concurrent
with the signing of the agreement, Biogen Idec made a $14.0 million equity
investment by purchasing shares of the Company’s Series C-2 preferred
stock.
10
Merck &
Co., Inc.
In
February 2003, the Company and Merck & Co., Inc. (“Merck”)
entered into a research collaboration to identify and optimize inhibitors of
beta-amyloid converting enzyme (“BACE”), which is believed to play a key role in
Alzheimer’s disease. This collaboration had an initial three-year research term
and a one-year option period. In November 2005, the one-year option was not
exercised by Merck and the research term of the collaboration ended in
February 2006. Accordingly, the upfront, non-refundable and non-creditable
technology access fee was recognized as revenue over the 36-month term of the
agreement ending February 2006. However, the Company retains the right to
earn milestone payments and royalties on any compound that results from the
collaboration. In June 2006, the Company received a $4.25 milestone payment
from Merck for meeting certain preclinical milestones related to
BACE.
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
agreed to be responsible for advancing these compounds into lead optimization,
preclinical development, and clinical studies. Merck is obligated to 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, nonrefundable and
noncreditable technology access fee of $2.3 million, which is being
recognized as revenue over an initial three-year research term, is entitled
to
receive annual license fees aggregating $0.95 million and may receive payments
based on the achievement of development milestones of up to $22.1 million.
In addition, the Company is entitled to 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
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 March
31,
|
|||||||
2007
|
2006
|
||||||
Merck
|
$
|
229,167
|
$
|
1,370,705
|
|||
Biogen
Idec-related party
|
2,037,099
|
1,688,859
|
|||||
Total
collaboration revenue
|
$
|
2,266,266
|
$
|
3,059,564
|
In
June 2000, the Company entered into an equipment financing agreement with
General Electric Capital Corporation (“GECC”). Various
credit lines have been issued under the financing agreement since 2000. The
current $2.6 million credit line is available through March 28, 2008. As of
March 31, 2007, the Company had drawn a total of $9.5 million under various
credit lines under the financing agreement and the outstanding balance was
$1.8
million, which bears interest at rates ranging from 7.4% to 10.61% per annum
and
is due in 36 to 48 monthly payments. The equipment loans are secured by the
equipment financed.
In
conjunction with a previous credit line of $2.5 million under the GECC
agreement, the Company issued warrants to the financing company to purchase
shares of the Company’s Series C preferred stock, which converted into
warrants to purchase 1,046 shares of common stock in connection with the
IPO. The fair value of the warrants issued is insignificant, as determined
using
the Black-Scholes options pricing model, and is being accounted for as prepaid
interest and expensed on a straight-line basis over the term of the agreement.
As
of
March 31, 2007 and December 31, 2006, the Company was in compliance with
all covenants in the GECC loan agreement.
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 may borrow up to $15.0 million. The Company
did not borrow any monies under this loan facility and this facility has
expired. In conjunction with this transaction, the Company issued warrants
to
the lenders to purchase up to 164,830 shares of common stock at a price of
$9.10 per share. These warrants are currently exercisable for 82,415 shares
of common stock and none of the remaining shares covered by the warrants will
vest or become exercisable. The Company also granted the lenders registration
rights under our Eighth Amended and Restated Investor Rights
Agreement.
11
The
fair
value of the warrants issued is $0.5 million, as determined using the
Black-Scholes options pricing model, and are being accounted for as prepaid
interest and expensed on a straight-line basis over the term of the agreement.
This prepaid interest was fully amortized as of December 31,
2006.
5
.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 March 31, 2007, 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.
6.
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.
7.
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 (the “2005
Plan”). The 2005 Plan is intended to serve as the successor equity incentive
program to the 1998 Plan and 2001 Plan. The Company has 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 1998 Plan or 2001 Plan that expire
unexercised or are repurchased by the Company pursuant to the terms of such
options. As of March 31, 2007, 2,450,606 shares have been granted under the
2005
Plan and 2,760 shares have been issued under this 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. The 2005 Plan was increased
by 860,445 shares on January 1, 2006 and by 1,082,352 shares on January 1,
2007
according to this provision and based on Board approval. The total shares
available for future grants under this 2005 Plan as of March 31, 2007 was
1,440,337. 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. Effective January 1, 2007, the Company’s Board of
Directors increased the 2006 Plan by an additional 200,000 shares such that
the
aggregate number of shares of common stock reserved for issuance under the
2006
Plan is 400,000 shares. 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 March 31,
2007, 135,000 shares have been granted under the 2006 Plan and no shares
have been issued under this plan.
12
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, 2006
|
3,942,435
|
$
|
4.30
|
||||||||||
Options
granted
|
64,500
|
$
|
4.40
|
||||||||||
Options
exercised
|
(30,178
|
)
|
$
|
2.40
|
|||||||||
Options
canceled/forfeited/expired
|
(10,769
|
)
|
$
|
5.15
|
|||||||||
Balance
at March 31, 2007
|
3,965,988
|
$
|
4.31
|
7.86
|
$
|
2,778
|
|||||||
Exercisable
at March 31, 2007
|
1,898,379
|
$
|
3.51
|
6.58
|
$
|
2,552
|
13
The
following table summarizes outstanding and exercisable options as of March
31,
2007:
OPTIONS OUTSTANDING
|
OPTIONS EXERCISABLE
|
|||||||||||||||
Range of
Exercise Prices
|
Number
Outstanding
As of 3/31/07
|
Weighted
Average
Remaining
Contractual
Term
|
Weighted
Average
Exercise
Price
|
Number
Exercisable
As of 3/31/07
|
Weighted
Average
Exercise
Price
|
|||||||||||
$
0.43- $ 1.28
|
21,417
|
2.35
|
$
|
0.72
|
21,417
|
$
|
0.72
|
|||||||||
$
2.55
|
1,351,074
|
5.68
|
$
|
2.55
|
1,248,742
|
$
|
2.55
|
|||||||||
$
3.19 - $ 4.74
|
238,256
|
9.26
|
$
|
4.31
|
37,815
|
$
|
3.59
|
|||||||||
$
4.85
|
747,174
|
9.54
|
$
|
4.85
|
77,949
|
$
|
4.85
|
|||||||||
$
4.93 - $ 5.162
|
128,029
|
9.26
|
$
|
5.04
|
13,633
|
$
|
5.13
|
|||||||||
$
5.25
|
1,152,733
|
8.67
|
$
|
5.25
|
397,891
|
$
|
5.25
|
|||||||||
$
5.50 - $ 6.35
|
195,400
|
9.30
|
$
|
5.99
|
45,650
|
$
|
6.01
|
|||||||||
$
6.40
|
23,900
|
9.08
|
$
|
6.40
|
-
|
$
|
-
|
|||||||||
$
7.15
|
22,400
|
9.00
|
$
|
7.15
|
5,600
|
$
|
7.15
|
|||||||||
$
9.56
|
85,605
|
8.18
|
$
|
9.56
|
49,682
|
$
|
9.56
|
|||||||||
$
0.43 - $ 9.56
|
3,965,988
|
7.86
|
$
|
4.31
|
1,898,379
|
$
|
3.51
|
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 months ended March 31, 2007 and 2006 was approximately $0.17
million and $0.15 million, respectively. The estimated fair value of shares
vested during the three months ended March 31, 2007 and 2006 was $0.58 million
and $0.47 million, respectively. At March 31, 2007, total unrecognized estimated
compensation cost related to non-vested stock options granted prior to that
date
was $7.0 million and the cost is expected to be recognized over a weighted
average period of 2.64 years.
The
total intrinsic value of stock options exercised during the three months ended
March 31, 2007 and 2006 was $0.07 million and $0.17 million, respectively.
The
Company recorded cash received from the exercise of stock options of $0.07
million and $0.13 million, respectively during the three months ended March
31,
2007 and 2006, respectively. 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 months ended March
31, 2007 and 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 March 31, 2007, 145,632 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. The ESPP was increased
by
107,556 shares on January 1, 2006 and by 135,294 shares on January 1, 2007
according to this provision and based on Board approval. At March 31, 2007,
the
total shares reserved for future issuance under the ESPP was 300,159. 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 months ended
March 31, 2007 was approximately $0.06 million.
8.
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 March 31, 2007.
14
9.
Subsequent Event
In
April
2007, the Company earned a $1.0 million payment from Merck & Co., Inc. for
meeting a preclinical milestone in the companies' collaboration to develop
oral
small molecule inhibitors of BACE. This payment was received in May
2007.
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 March 31,
2007 and results of operations for the three months ended March 31, 2007 and
2006 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 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 2 clinical trial in small cell lung cancer,
one Phase 2 clinical trial in ovarian cancer and one Phase 1 clinical trial
in acute leukemias. Our second most advanced product candidate, SNS-032, is
a
CDK inhibitor. We are currently conducting a Phase 1 clinical trial with
SNS-032 in patients with advanced solid tumors and a Phase 1 clinical trial
in
patients with advanced B-cell malignancies. We are also developing SNS-314,
an
Aurora kinase inhibitor, for the treatment of cancer for which we filed an
IND
in February 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.
As
of
April 30, 2007, we had four ongoing strategic collaborations, one of which
involves active participation by our personnel, with three leading
pharmaceutical and biopharmaceutical companies. As of March 31, 2007, we had
received an aggregate of approximately $76.0 million in cash from our current
and former collaboration and licensing partners in the form of stock purchase
proceeds and fees from our current and former collaboration
partners.
Since
our
inception, we have generated significant losses. As of March 31, 2007, we had
an
accumulated deficit of $249.6 million, including a deemed dividend of
$88.1 million recorded in conjunction with our IPO in September 2005.
We expect our net losses to increase primarily due to our anticipated clinical
trial activities.
15
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 months ended March
31,
2007 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, 2006.
Results
of Operations
Three
Months Ended March 31, 2007 and 2006
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, most of our
revenue has consisted of collaboration revenue and grant and fellowship revenue.
In the three months ended March 31, 2007, we received $0.25 million from
SARcode, which was recognized as license 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 months ended March 31, 2007 and 2006 from
each of our collaboration partners.
|
Three
months ended March 31,
|
||||||
|
2007
|
2006
|
|||||
Merck
|
$
|
229,167
|
$
|
1,370,705
|
|||
Biogen
Idec-related party
|
2,037,099
|
1,688,859
|
|||||
Total
collaboration revenue
|
$
|
2,266,266
|
$
|
3,059,564
|
Collaboration
revenue decreased from $3.1 million for the three months ended March 31, 2006
to
$2.3 million for the same period in 2007, primarily due to a decrease in
collaboration revenue from Merck resulting from the termination of the research
phase of the BACE collaboration, partially off-set by a $0.35 million increase
in revenue from Biogen Idec due to an increase in the number of our employees
engaged in the collaboration and paid for by Biogen Idec. We expect that revenue
from reimbursed research services will decrease for 2007 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 compounds that result from the collaborations.
Grant
and Fellowship Revenue.
We
recognized no grant and fellowship revenue during the first three months ended
March 31, 2007 compared to $0.04 million from the same period in 2006. Grant
and
fellowship revenue is recognized as we perform services under the
applicable grant. As of March 31, 2007, 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 have not received
any
grant since the first quarter of 2006 and 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 1
and Phase 2 clinical trial costs for SNS-595 and Phase 1 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,
including our SNS-314 Aurora kinase program, and in connection with in-licensing
activities. We expense all research and development costs as they are incurred.
The table below sets forth our research and development expense for the three
months ended March 31, 2007 and 2006 for our product candidate programs:
16
Three months ended March
31,
|
|||||||
2007
|
2006
|
||||||
(in thousands)
|
|||||||
SNS-595
|
$
|
3,025
|
$
|
1,471
|
|||
SNS-032
|
862
|
475
|
|||||
SNS-032
- milestone payment to BMS
|
—
|
2,000
|
|||||
SNS-314
|
1,330
|
1,110
|
|||||
Other
kinase inhibitors
|
3,185
|
3,014
|
|||||
Discovery
and New Technology
|
878
|
1,219
|
|||||
Other
programs
|
27
|
427
|
|||||
Total
|
$
|
9,307
|
$
|
9,716
|
Research
and development expense decreased from $9.7 million for the three months ended
March 31, 2006 to $9.3 million for the same period in 2007. The 2006 period
included a $2.0 million milestone payment to Bristol Myers Squibb (“BMS”). Net
of this payment, research and development expenses increased from $7.7 million
for the three months ended March 31, 2006 to $9.3 million for the same period
in
2007. This increase is primarily due to (i) a $1.6 million increase in spending
on development of our lead program SNS-595, (ii) a $0.39 million increase in
spending on the development of our CDK inhibitor SNS-032 and (iii) a $0.22
million increase in spending for the development of our Aurora inhibitor program
SNS-314, partially offset by reduced spending on discovery and new technologies
and other programs.
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, SNS-032 and SNS-314 progress through the
clinical development stage and we bring additional product candidates 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 -based compensation. Other significant costs include
facilities costs and fees paid to outside legal advisors and auditors. General
and administrative expense was $3.3 million and $2.7 million for the three
months ended March 31, 2007 and 2006, respectively. This $0.6 million increase
is due to (i) a $0.25 million increase in payroll and related expenses,
including a $0.14 million increase in non-cash stock-based compensation expense
due to options granted to employees in 2006, (ii) a $0.19 million increase
in
other personnel expenses, and (iii) a $0.18 million increase in office and
facilities related expenses.
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.
Interest
Income.
Interest
income increased from $0.55 million for the three months ended March 31, 2006
to
$0.77 million for the three months ended March 31, 2007, primarily due to higher
interest rates and higher average balances of cash, cash equivalents and
marketable securities resulting from cash received pursuant to a private
placement of our common stock and warrants to purchase our common stock (“2006
PIPE Financing”) in March 2006.
Interest
Expense.
Interest
expense decreased from $0.23 million for the three months ended March 31, 2006
to $0.05 million for the same period in 2007 due to lower outstanding debt
obligations in 2007.
17
Liquidity
and Capital Resources
As
of
March 31, 2007, we had cash, cash equivalents and marketable securities of
$53.1 million and outstanding equipment financing of $1.8 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 . 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 $9.5 million and $8.5 million for the
three months ended March 31, 2007 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-based compensation expense, and for the first three months
ended March 31, 2006, a $2.0 million non-cash milestone payments to
BMS.
Net
cash
provided by investing activities was $14.4 million and $3.6 million for the
three months ended March 31, 2007 and March 31, 2006, respectively. The cash
provided during the three months ended March 31, 2007 was primarily attributable
to the net maturities of $14.9 million of securities, partially offset by the
purchase of property and equipment totaling $0.5 million. Net cash provided
by
investing activities during the three months ended March 31, 2006 was related
to
the net maturities of $4.7 million of securities, partially off-set by the
purchase of property and equipment of $1.0 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 $0.07 million and $43.5 million for
the three months ended March 31, 2007 and 2006, respectively. Our financing
activities for the 2007 period consisted primarily of $0.07 million in proceeds
from stock option exercises and $0.25 million pursuant to an equipment loan,
offset by the net repayment of $0.25 million in equipment loans related to
capital equipment purchases in prior periods. Our
financing activities for the first quarter of 2006 consisted primarily of the
issuance of 7,246,377 shares of common stock and warrants to purchase additional
2,173,914 shares of common stock for net proceeds of $43.7 million in a private
placement which closed on March 17, 2006, partially off-set by the repayment
of
equipment loan of $0.34 million.
Credit
and Loan Arrangements
In
June 2000, the Company entered into an equipment financing agreement with
General Electric Capital Corporation (“GECC”). Various
credit lines have been issued under the financing agreement since 2000. The
current $2.6 million credit line is available through March 28, 2008. As
of
March 31, 2007, the Company had drawn a total of $9.5 million under various
credit lines under the financing agreement and the outstanding balance was
$1.8
million, which bears interest at rates ranging from 7.4% to 10.61% per annum
and
is due in 36 to 48 monthly payments. The equipment loans are secured by the
equipment financed.
In
conjunction with a previous credit line of $2.5 million under the GECC
agreement, the Company issued warrants to the financing company to purchase
shares of the Company’s Series C preferred stock, which converted into
warrants to purchase 1,046 shares of common stock in connection with the
IPO. The fair value of the warrants issued is insignificant, as determined
using
the Black-Scholes options pricing model, and is being accounted for as prepaid
interest and expensed on a straight-line basis over the term of the agreement.
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. We did not borrow any monies
under this loan facility and this facility has expired. In conjunction with
this
transaction, we issued warrants to the lenders to purchase up to
164,830 shares of common stock at a price of $9.10 per share, half of
which are currently exercisable. These warrants are currently exercisable for
82,412 shares of common stock and none of the remaining warrants will vest
or
become exercisable. We also granted the lenders registration rights under our
Eighth Amended and Restated Investor Rights Agreement.
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 revenue
generated from our collaborations, will be sufficient to fund our operations
at
least through the middle of 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 commercialize
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.
18
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 2006 and the first
three months of 2007, 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.
Item
4. Controls and Procedures
Evaluation
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.
19
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.
Changes
in Internal Control over Financial Reporting. There
have been no changes in our internal control over financial reporting during
the
first quarter of 2007 that have materially affected, or are reasonably likely
to
materially affect, our internal control over financial reporting.
Our
Annual Report on Form 10-K for the year ended December 31, 2006
includes a detailed discussion of our risk factors.
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 $42.0 million. We issued an
additional 51,126 shares on November 1, 2005 for gross proceeds of $0.36 million
in connection with the underwriters’ partial exercise of their over-allotment
option. We paid the underwriters a commission of $3.0 million and incurred
additional offering expenses of approximately $2.2 million. After deducting
the
underwriters’ commission and the offering expenses, the registrant received net
proceeds of approximately $37.2 million.
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.
None.
Item
6. Exhibits
20
Exhibit
Number
|
Description
|
|
10.48
|
Amended
and Restated Consulting Agreement, effective August 8, 2005, by and
between the Registrant and James A. Wells, Ph. D., as amended by
the
Amendment to the Amended and Restated Consulting Agreement, effective
December 21, 2005.
|
|
10.49
|
Consulting
Agreement, dated August 17, 2006, by and between the Registrant and
Homer
L. Pearce, Ph. D.
|
|
10.50
|
Consulting
Agreement, dated September 2, 2006, by and between the Registrant
and
David C. Stump, M. D.
|
|
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.
|
21
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, Corporate Development and Finance, Chief Financial
Officer
|
Date:
May
9, 2007
22
EXHIBIT INDEX
Exhibit
Number
|
Description
|
|
10.48
|
Amended
and Restated Consulting Agreement, effective August 8, 2005, by and
between the Registrant and James A. Wells, Ph. D., as amended by
the
Amendment to the Amended and Restated Consulting Agreement, effective
December 21, 2005.
|
|
10.49
|
Consulting
Agreement, dated August 17, 2006, by and between the Registrant and
Homer
L. Pearce, Ph. D.
|
|
10.50
|
Consulting
Agreement, dated September 2, 2006, by and between the Registrant
and
David C. Stump, M. D.
|
|
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.
|
23