PART I
FORWARD-LOOKING STATEMENTS
This quarterly report on
Form 10-Q contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995 that involve risks and
uncertainties, as well as assumptions that, if they never materialize or prove
incorrect, could cause the results of Sirtris to differ materially from those
expressed or implied by such forward-looking statements. All statements other
than statements of historical fact are statements that could be deemed
forward-looking statements, including any projections of financing needs,
revenue, expenses, earnings or losses from operations, or other financial
items; any statements of the plans, strategies and objectives of management for
future operations; any statements concerning product research, development and
commercialization plans and timelines; any statements regarding safety and
efficacy of product candidates, any statements of expectation or belief; and
any statements of assumptions underlying any of the foregoing. In addition,
forward looking statements may contain the words believe, anticipate, expect,
estimate, intend, plan, project, will be, will continue, will
result, seek, could, may, might, or any variations of such words or
other words with similar meanings.
The risks, uncertainties
and assumptions referred to above include risks that are described in Risk
Factors and elsewhere in this quarterly report and that are otherwise
described from time to time in our Securities and Exchange Commission reports
filed after this report.
The forward-looking
statements included in this quarterly report represent our estimates as of the
date of this quarterly report. We specifically disclaim any obligation to
update these forward-looking statements in the future. These forward-looking
statements should not be relied upon as representing our estimates or views as
of any date subsequent to the date of this quarterly report.
Item 1. Financial Statements - Unaudited
The financial information
set forth below should be read in conjunction with our Managements Discussion
and Analysis of Financial Condition and Results of Operations appearing
elsewhere in this Quarterly Report on Form 10-Q.
1
Sirtris
Pharmaceuticals, Inc.
(A
development-stage company)
Consolidated Balance Sheets
(in thousands, except per
share amounts)
(Unaudited)
|
|
|
|
|
|
|
|
September 30,
|
|
December 31,
|
|
|
|
2007
|
|
2006
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
27,995
|
|
$
|
7,513
|
|
Short-term
investments
|
|
99,132
|
|
42,497
|
|
Prepaid expenses
and other current assets
|
|
1,489
|
|
346
|
|
Restricted cash
|
|
26
|
|
26
|
|
Total current
assets
|
|
128,642
|
|
50,382
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
2,228
|
|
1,481
|
|
Other assets
|
|
185
|
|
223
|
|
Restricted cash
|
|
2,100
|
|
|
|
Total assets
|
|
$
|
133,155
|
|
$
|
52,086
|
|
|
|
|
|
|
|
Liabilities
and stockholders equity
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
Accounts payable
|
|
$
|
2,391
|
|
$
|
829
|
|
Accrued expenses
|
|
1,755
|
|
1,197
|
|
Current portion
of notes payable
|
|
2,436
|
|
1,018
|
|
Total current
liabilities
|
|
6,582
|
|
3,044
|
|
|
|
|
|
|
|
Warrants to
purchase shares subject to redemption
|
|
|
|
438
|
|
Notes payable,
net of current portion and discount
|
|
7,361
|
|
9,425
|
|
|
|
|
|
|
|
Redeemable
convertible preferred stock, at liquidation value
|
|
|
|
66,813
|
|
|
|
|
|
|
|
Stockholders
(deficit) equity:
|
|
|
|
|
|
Preferred stock,
$0.001 par value; 20,000 shares authorized; none issued
|
|
|
|
|
|
Common stock,
$0.001 par value: 206,575 shares authorized; 28,699 and 1,345 shares issued
and outstanding at September 30, 2007 and December 31, 2006,
respectively
|
|
29
|
|
1
|
|
Additional
paid-in capital
|
|
169,599
|
|
916
|
|
Accumulated
other comprehensive income
|
|
195
|
|
22
|
|
Deficit
accumulated during the development stage
|
|
(50,611
|
)
|
(28,573
|
)
|
Total
stockholders equity (deficit)
|
|
119,212
|
|
(27,634
|
)
|
Total
liabilities, redeemable convertible preferred stock and stockholders
(deficit) equity
|
|
$
|
133,155
|
|
$
|
52,086
|
|
|
|
|
|
|
|
|
|
|
2
Sirtris
Pharmaceuticals, Inc.
(A
development-stage company)
Consolidated
Statements of Operations
(in thousands, except share and per share
amounts)
(Unaudited)
|
|
Three months ended September 30,
|
|
Nine months ended September 30,
|
|
Period from March 25, 2004 (date of inception) through
|
|
|
|
2007
|
|
2006
|
|
2007
|
|
2006
|
|
September 30, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
68
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development (1)
|
|
9,454
|
|
4,236
|
|
20,749
|
|
10,595
|
|
43,243
|
|
General and
administrative (1)
|
|
1,584
|
|
1,070
|
|
4,135
|
|
3,266
|
|
13,039
|
|
Total operating
expenses
|
|
11,038
|
|
5,306
|
|
24,884
|
|
13,861
|
|
56,282
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(11,038
|
)
|
(5,306
|
)
|
(24,884
|
)
|
(13,861
|
)
|
(56,214
|
)
|
Interest income
|
|
1,717
|
|
717
|
|
3,905
|
|
1,746
|
|
7,540
|
|
Interest expense
|
|
(331
|
)
|
(295
|
)
|
(1,059
|
)
|
(519
|
)
|
(1,937
|
)
|
Net loss
|
|
$
|
(9,652
|
)
|
$
|
(4,884
|
)
|
$
|
(22,038
|
)
|
$
|
(12,634
|
)
|
$
|
(50,611
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share - basic and diluted
|
|
$
|
(0.34
|
)
|
$
|
(5.57
|
)
|
$
|
(1.54
|
)
|
$
|
(15.32
|
)
|
|
|
Weighted average
number of common shares used in net loss per basic and diluted
|
|
28,522,615
|
|
877,313
|
|
14,328,095
|
|
824,588
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Amounts
include stock-based compensation expense, as follows:
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
1,147
|
|
$
|
133
|
|
$
|
2,214
|
|
$
|
374
|
|
General and
administrative
|
|
$
|
194
|
|
$
|
66
|
|
$
|
414
|
|
$
|
125
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3
Sirtris
Pharmaceuticals, Inc.
(A
development-stage company)
Consolidated
Statements of Cash Flow
(in thousands)
(Unaudited)
|
|
Nine months ended September 30,
|
|
Period from March 25, 2004 (date of inception) through
|
|
|
|
2007
|
|
2006
|
|
September 30, 2007
|
|
|
|
|
|
|
|
|
|
Operating
activities
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(22,038
|
)
|
$
|
(12,634
|
)
|
$
|
(50,611
|
)
|
Adjustments to
reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
Depreciation and
amortization
|
|
432
|
|
202
|
|
857
|
|
Stock-based
compensation expense
|
|
2,628
|
|
499
|
|
3,521
|
|
Issuance of
common stock in exchange for licenses and services
|
|
|
|
|
|
82
|
|
Non-cash rent
expense
|
|
72
|
|
|
|
97
|
|
Non-cash
interest expense
|
|
177
|
|
|
|
269
|
|
Change in
operating assets and liabilities:
|
|
|
|
|
|
|
|
Prepaid expenses
and other current assets
|
|
(1,143
|
)
|
(157
|
)
|
(1,489
|
)
|
Other assets
|
|
38
|
|
(236
|
)
|
(219
|
)
|
Accounts payable
|
|
1,562
|
|
337
|
|
2,391
|
|
Accrued expenses
|
|
558
|
|
641
|
|
1,755
|
|
Net cash used in
operating activities
|
|
(17,714
|
)
|
(11,348
|
)
|
(43,347
|
)
|
|
|
|
|
|
|
|
|
Investing
activities
|
|
|
|
|
|
|
|
Purchases of
property and equipment
|
|
(1,179
|
)
|
(717
|
)
|
(3,084
|
)
|
Purchases of
short-term investments
|
|
(147,873
|
)
|
(32,434
|
)
|
(257,300
|
)
|
Sales and
maturities of short-term investments
|
|
91,412
|
|
31,075
|
|
158,364
|
|
Increase in
restricted cash
|
|
(2,100
|
)
|
|
|
(2,126
|
)
|
Net cash (used
in) provided by investing activities
|
|
(59,740
|
)
|
(2,076
|
)
|
(104,146
|
)
|
|
|
|
|
|
|
|
|
Financing
activities
|
|
|
|
|
|
|
|
Proceeds from
issuance of redeemable convertible preferred stock
|
|
35,890
|
|
21,968
|
|
102,565
|
|
Proceeds from
issuance of common stock
|
|
62,540
|
|
20
|
|
62,620
|
|
Proceeds from
note payable
|
|
|
|
10,797
|
|
10,797
|
|
Repayment of
note payable
|
|
(494
|
)
|
|
|
(494
|
)
|
Net cash
provided by financing activities
|
|
97,936
|
|
32,785
|
|
175,488
|
|
|
|
|
|
|
|
|
|
Net increase in
cash and cash equivalents
|
|
20,482
|
|
19,361
|
|
27,995
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents at beginning of the period
|
|
7,513
|
|
7,836
|
|
|
|
Cash
and cash equivalents at end of the period
|
|
$
|
27,995
|
|
$
|
27,197
|
|
$
|
27,995
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of non-cash financing activities:
|
|
|
|
|
|
|
|
Accretion of redeemable
convertible preferred stock to redemption value
|
|
$
|
36
|
|
$
|
54
|
|
$
|
174
|
|
Discount to note
payable for warrant valuation
|
|
$
|
191
|
|
$
|
413
|
|
$
|
604
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4
Sirtris
Pharmaceuticals, Inc.
(A
development-stage company)
Notes to Consolidated Financial Statements
(
in thousands, except share and per share amounts
)
(Unaudited)
1. Basis of Presentation
The accompanying
unaudited consolidated financial statements have been prepared in accordance
with accounting principles generally accepted in the United States (GAAP) for
interim financial reporting and as required by Regulation S-X, Rule 10-01.
Accordingly, they do not include all of the information and footnotes required
by GAAP for complete financial statements. In the opinion of management, all
adjustments (including those which are normal and recurring) considered
necessary for a fair presentation of the interim financial information have
been included. When preparing financial statements in conformity with GAAP, the
Company must make estimates and assumptions that affect the reported amounts of
assets, liabilities, revenues, expenses and related disclosures at the date of
the financial statements. Actual results could differ from those estimates.
Additionally, operating results for the three and nine months ended September
30, 2007 are not necessarily indicative of the results that may be expected for
any other interim period or for the fiscal year ending December 31, 2007.
The accompanying
unaudited consolidated financial statements and notes thereto should be read in
conjunction with the audited consolidated financial statements for the year
ended December 31, 2006 included in the Companys Registration Statement on
Form S-1(as amended), which was declared effective by the Securities and
Exchange Commission (SEC) on May 22, 2007.
2. Recent Accounting Pronouncements
In September 2006,
the FASB issued FASB Statement No. 157, Fair Value Measurements, or SFAS 157,
which defines fair value, establishes a framework for measuring fair value
under GAAP, and expands disclosures about fair value measurements.
SFAS 157 applies to other accounting pronouncements that require or permit
fair value measurements. The new guidance is effective for financial statements
issued for fiscal years beginning after November 15, 2007, and for interim
periods within those fiscal years. The Company is currently evaluating the
requirements of SFAS 157; however, it does not believe that the adoption
will have a material effect on its consolidated financial statements.
In February 2007, the
FASB released SFAS No. 159, The Fair Value Option for Financial Assets and
Financial Liabilities, or SFAS No. 159. SFAS No. 159 permits entities to
choose to measure many financial instruments and certain other items at fair
value. The objective is to improve financial reporting by providing entities
with the opportunity to mitigate volatility in reported earnings caused by
measuring related assets and liabilities differently without having to apply
complex hedge accounting provisions. SFAS No. 159 is effective for fiscal years
beginning after November 15, 2007. The Company is currently analyzing the
effect, if any, SFAS No. 159 will have on its consolidated financial position
and results of operations.
In June 2007, the FASB
issued EITF Issue No. 07-3, Accounting for Nonrefundable Advance Payments for
Goods or Services to Be Used in Future Research and Development Activities, or
EITF 07-3. EITF 07-3 requires that nonrefundable advance payments for
goods or services to be received in the future for use in research and
development activities should be deferred and capitalized. The
capitalized amounts should be expensed as the related goods are delivered or
the services are performed. EITF 07-3 is effective for new contracts
entered into during fiscal years beginning after December 15, 2007. The
Company is currently analyzing the effect, if any, EITF 07-3 will have on its
consolidated financial position and results of operations.
The Company adopted the
provisions of Financial Standards Accounting Board Interpretation No. 48
Accounting for Uncertainty in Income Taxes (FIN 48) an interpretation of FASB
Statement No. 109 (SFAS 109) on January 1, 2007. As a result of the
implementation of FIN 48, it recorded no adjustment for unrecognized income tax
benefits. At the adoption date of FIN 48, January 1, 2007 and also at
September 30, 2007, the Company had no unrecognized tax benefits.
The Company recognizes
interest and penalties related to uncertain tax positions in income tax
expense. As of September 30, 2007, it had no accrued interest or penalties
related to uncertain tax positions.
The tax years 2004
through 2006 remain open to examination by the major taxing jurisdictions to
which the Company is subject.
At December 31,
2006, the Company had federal and state net operating loss (NOL)
carryforwards of $7,272 and $10,031, respectively, available to reduce future
taxable income, which expire at various dates beginning in 2010 through
2027. The Company also had federal and
state research and development tax credit carryforwards of $352 and $266,
respectively, available to reduce future tax liabilities and which expire at
various dates beginning in 2020 through 2027.
Utilization of the NOL and tax credit carryforwards may be subject to a
substantial annual limitation due to ownership change limitations that have
occurred previously or that could occur in the future provided by
Section 382 of the Internal Revenue Code of 1986, as well as similar state
and foreign provisions. These ownership changes may limit the amount of NOL and
tax credit carryforwards that can be utilized
5
Sirtris
Pharmaceuticals, Inc.
(A
development-stage company)
Notes to Consolidated Financial Statements (Continued)
(
in thousands, except share and per share amounts
)
(Unaudited)
annually to offset future
taxable income and tax, respectively. In general, an ownership change, as
defined by Section 382, results from transactions increasing the ownership
of certain shareholders or public groups in the stock of a corporation by more
than 50 percentage points over a three-year period. Since the Companys
formation, the Company has raised capital through the issuance of capital stock
on several occasions which, combined with the purchasing shareholders
subsequent disposition of those shares, may have resulted in a change of
control, as defined by Section 382, or could result in a change of control
in the future upon subsequent disposition. The Company has not currently
completed a study to assess whether a change of control has occurred or whether
there have been multiple changes of control since the Companys formation due
to the significant complexity and cost associated with such study and that
there could be additional changes in control in the future. If the Company has
experienced a change of control at any time since Company formation,
utilization of its NOL or tax credit carryforwards would be subject to an
annual limitation under Section 382. Further, until a study is completed
and any limitation known, no amounts are being presented as an uncertain tax
position under FIN 48.
In addition to
uncertainties surrounding the use of NOL carryforwards in a change of control,
the Company has identified research and development credits as material
components of its deferred tax asset. The uncertainties in these components
arise from judgments in the allocation of costs utilized to calculate these
credits. The Company has not conducted studies to analyze these credits to
substantiate the amounts due to the significant complexity and cost associated
with such study. Any limitation may result in expiration of a portion of the
NOL or tax credits before utilization. Further, until a study is completed and
any limitation known, no amounts are being presented as an uncertain tax
position under FIN 48.
3. Cash and cash equivalents
Cash equivalents include
all highly liquid investments maturing within 90 days from the date of
purchase. Cash equivalents consist of money market funds, certificates of
deposit, U.S. agency notes, corporate bonds and commercial paper.
4. Short-term investments
Short-term investments
consist primarily of investments with original maturities greater than ninety
days and less than one year when purchased. The Company classifies these
investments as available-for-sale as defined by SFAS No. 115
,
Accounting for Certain Investments
in Debt and Equity Securities
.
Unrealized gains and losses are included in other
comprehensive income (loss).
Short-term investments
included the following at September 30, 2007 and December 31, 2006:
|
|
|
|
Gross
|
|
Gross
|
|
|
|
|
|
|
|
Unrealized
|
|
Unrealized
|
|
Fair
|
|
September 30, 2007
|
|
Cost
|
|
Gains
|
|
Losses
|
|
Value
|
|
Commercial paper
|
|
$
|
53,595
|
|
$
|
169
|
|
$
|
|
|
$
|
53,764
|
|
Asset-backed
securities
|
|
24,490
|
|
20
|
|
|
|
24,510
|
|
Corporate debt
securities
|
|
20,852
|
|
12
|
|
(6
|
)
|
20,858
|
|
|
|
$
|
98,937
|
|
$
|
201
|
|
$
|
(6
|
)
|
$
|
99,132
|
|
|
|
|
|
Gross
|
|
Gross
|
|
|
|
|
|
|
|
Unrealized
|
|
Unrealized
|
|
Fair
|
|
December 31, 2006
|
|
Cost
|
|
Gains
|
|
Losses
|
|
Value
|
|
Commercial paper
|
|
$
|
33,980
|
|
$
|
17
|
|
$
|
|
|
$
|
33,997
|
|
Asset-backed
securities
|
|
3,876
|
|
1
|
|
|
|
3,877
|
|
Corporate debt
securities
|
|
4,619
|
|
4
|
|
|
|
4,623
|
|
|
|
$
|
42,475
|
|
$
|
22
|
|
$
|
|
|
$
|
42,497
|
|
All short-term
investments have contractual maturities of less than one year. Investments with
unrealized losses were in an unrealized loss position for less than a year. As
of September 30, 2007, the Company held 3 investments that were in an
unrealized loss position. The Company
reviewed its investments with unrealized losses and has concluded that no
other-than-temporary impairment existed at September 30, 2007 and
December 31, 2006 as the Company has the ability and intent to hold these
investments to anticipated recovery.
5. Comprehensive Loss
The Companys total
comprehensive loss consists of the following:
|
|
Three months ended September 30,
|
|
Nine months ended September 30,
|
|
|
|
2007
|
|
2006
|
|
2007
|
|
2006
|
|
Net loss
applicable to common stockholders
|
|
$
|
(9,652
|
)
|
$
|
(4,903
|
)
|
$
|
(22,074
|
)
|
$
|
(12,688
|
)
|
Other
comprehensive loss:
|
|
|
|
|
|
|
|
|
|
Unrealized gain
on investments
|
|
157
|
|
29
|
|
174
|
|
58
|
|
Comprehensive
loss
|
|
$
|
(9,495
|
)
|
$
|
(4,874
|
)
|
$
|
(21,900
|
)
|
$
|
(12,630
|
)
|
6
Sirtris
Pharmaceuticals, Inc.
(A
development-stage company)
Notes to Consolidated Financial Statements (Continued)
(
in thousands, except share and per share amounts
)
(Unaudited)
6.
Accounting for Stock-Based Compensation
The Company follows the
provisions of Statement of Financial
Accounting Standards No. 123 (revised 2004), Share Based Payment (SFAS
123R) . Under SFAS 123R, the Company is required to recognize, as expense, the
estimated fair value of all share based payments to employees. For the
three and nine months ended September 30, 2007, the Company recorded
stock-based compensation expense of approximately $302 and $649, respectively,
in connection with its share-based payment awards to employees.
Equity instruments issued
to non-employees are recorded at their fair value as determined in accordance
with SFAS 123(R) and EITF Issue No. 96-18, Accounting for Equity
Instruments That are Issued to Other Than Employees for Acquiring, or in
Conjunction with Selling Goods and Services (EITF 96-18) and are periodically
revalued as the equity instruments vest and are recognized as expense over the
related service period.
Stock
Plans
The Companys 2004 Stock
Option Plan (Plan), as amended, provides for the issuance of a total of 4,047,157 shares of common stock in the
form of incentive stock options, awards of stock, and direct stock purchase
opportunities to directors, officers,
employees and consultants of the Company.
Generally, stock options granted to employees pursuant to the Plan fully
vest four years from the grant date, with 25% of the award vesting after one
year and 6.25% of the award vesting quarterly thereafter. Stock options have a
term of 10 years. The Plan includes an evergreen provision that allows
for an annual increase in the number of shares of common stock available for
issuance under the Plan. The annual
increase will be added on the first day of each fiscal year from 2008 through
2013, inclusive, and will be equal to the lesser of (i) 1,904,762 shares; (ii)
3.5% of the number of then-outstanding shares of stock; and (iii) a number as
determined by the board of directors.
As of September 30, 2007,
there were 451,043 shares available for future issuance under the plan.
A summary of the status
of our stock option plan at September 30, 2007 and changes during the nine
months then ended is presented in the table and narrative below:
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
|
|
Average
|
|
|
|
|
|
|
|
Weighted-
|
|
Remaining
|
|
|
|
|
|
|
|
Average
|
|
Contractual
|
|
Aggregate
|
|
|
|
Options
|
|
Exercise Price
|
|
Term
|
|
Intrinsic Value
|
|
Options
outstanding at December 31, 2006
|
|
2,538,141
|
|
$
|
0.84
|
|
9.02
|
|
$
|
9,634
|
|
Options granted
|
|
526,579
|
|
$
|
7.01
|
|
|
|
|
|
Options
exercised
|
|
(179,118
|
)
|
$
|
0.39
|
|
|
|
|
|
Options
forfeited or expired
|
|
(56,071
|
)
|
$
|
5.06
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options
outstanding at September 30, 2007
|
|
2,829,531
|
|
$
|
1.92
|
|
8.51
|
|
$
|
42,902
|
|
Vested or
expected to vest at September 30, 2007
|
|
2,596,152
|
|
$
|
1.89
|
|
8.50
|
|
$
|
39,424
|
|
Options
exercisable at September 30, 2007
|
|
802,857
|
|
$
|
0.60
|
|
8.16
|
|
$
|
13,233
|
|
The aggregate intrinsic
value in the table above represents the value (the difference between the
Companys closing common stock price on September 30, 2007 and the exercise
price of the options, multiplied by the number of in-the-money options) that
would have been received by the option holders had all option holders exercised
their options on September 30, 2007. As of September 30, 2007, there was $3.1
million of total unrecognized stock-based compensation expense related to stock
options granted under the Plan. The expense is expected to be recognized over a
weighted-average period of 2.54 years. The weighted-average grant date fair
value of options granted during the three and nine months ended September 30,
2007 was $7.76 and $4.50, respectively. The intrinsic value of stock options
exercised for the three and nine months ended September 30, 2007 was $50 and
$605, respectively, and represents the difference between the exercise price of
the option and the market price of the Companys common stock on the dates
exercised.
The Company values stock
options using a Black-Scholes method of valuation and has applied the
weighted-average assumptions set forth in the following table. The resulting
fair value is recorded as compensation cost on a straight line basis over the
requisite service period, which generally equals the option vesting period.
Since the Company completed its initial public offering in May 2007, it did not
have sufficient history as a publicly traded company to evaluate its volatility
factor and expected term. As such, the Company analyzed the volatilities and
expected terms of a group of peer companies to support the assumptions used in
its calculations for the three and nine months ended September 30, 2007. The
Company averaged the volatilities and expected terms of
7
Sirtris
Pharmaceuticals, Inc.
(A
development-stage company)
Notes to Consolidated Financial Statements (Continued)
(
in thousands, except share and per share amounts
)
(Unaudited)
the peer companies with in-the-money
options, sufficient trading history and similar vesting terms to generate the
assumptions detailed above. The risk free interest rates are based on the
United States Treasury yield curve in effect for periods corresponding with the
expected life of the stock option.
|
|
Three Months ended September 30,
|
|
Nine months ended September 30,
|
|
|
|
2007
|
|
2006
|
|
2007
|
|
2006
|
|
Expected term
(life in years)
|
|
6.04
|
|
5.69
|
|
5.71
|
|
5.69
|
|
Interest rate
|
|
4.53
|
%
|
4.75
|
%
|
4.79.
|
%
|
4.75
|
%
|
Volatility
|
|
61.1
|
%
|
72.3
|
%
|
69.7
|
%
|
72.3
|
%
|
Dividend yield
|
|
|
|
|
|
|
|
|
|
Restricted
Stock
A summary of the status
of nonvested restricted stock as of September 30, 2007 and changes during the
nine months ended September 30, 2007 are as follows:
|
|
Shares
|
|
Nonvested at
December 31, 2006
|
|
164,166
|
|
Granted
|
|
|
|
Vested
|
|
(57,146
|
)
|
Canceled
|
|
(11,784
|
)
|
Nonvested at
September 30, 2007
|
|
95,236
|
|
Stock
Options Granted to Non-Employees
The Company granted stock
options to purchase 7,619 shares of common stock to non-employees at exercises
prices of $5.99 to $6.51 in the nine months ended September 30, 2007. No stock options were granted to
non-employees in the three months ended September 30, 2007. The stock options vest over periods of one to
four years. The Company has recorded the estimated fair value of the
nonemployee options on an accelerated basis under FASB Interpretation
No. 28 (FIN 28), Accounting for Stock Appreciation Rights and Other
Variable Stock Options or Award Plans (an interpretation of APB Opinion
No. 15 and 25 ). The assumptions used in the calculations were as follows:
(i) risk-free interest rate of 4.67%, (ii) contractual life of ten
years, (iii) volatility of 82.7% and (iv) no expected dividends. The
Company recognized stock-based compensation expense relating to the estimated
fair value of non-employee options of $1,039 and $1,979 for the three and nine
months ended September 30, 2007, respectively. The unvested stock options are
subject to remeasurement over the remaining service period.
7. Net Loss Per Share
The Company calculates
net loss per share in accordance with SFAS No. 128,
Earnings Per Share
. Basic and diluted net
loss per common share was determined by dividing net loss applicable to common
stockholders by the weighted average common shares outstanding during the
period. The Companys potentially dilutive shares, which include outstanding
common stock options, unvested restricted stock, convertible preferred stock,
redeemable convertible preferred stock, and warrants, have not been included in
the computation of diluted net loss per share for all periods as the result
would be anti-dilutive.
|
|
Three Months ended
September 30,
|
|
Nine months ended
September 30,
|
|
|
|
2007
|
|
2006
|
|
2007
|
|
2006
|
|
Net loss
|
|
$
|
(9,652
|
)
|
$
|
(4,884
|
)
|
$
|
(22,038
|
)
|
$
|
(12,634
|
)
|
Accretion of
redeemable convertible preferred stock issuance costs
|
|
|
|
(19
|
)
|
(36
|
)
|
(54
|
)
|
Net loss
applicable to common stockholders
|
|
$
|
(9,652
|
)
|
$
|
(4,903
|
)
|
$
|
(22,074
|
)
|
$
|
(12,688
|
)
|
Weighted-average
number of common shares used in net loss per share-basic and diluted
|
|
28,522,615
|
|
877,313
|
|
14,328,095
|
|
824,588
|
|
Net loss per
share applicable to common stockholdersbasic and diluted
|
|
$
|
(0.34
|
)
|
$
|
(5.59
|
)
|
$
|
(1.54
|
)
|
$
|
(15.39
|
)
|
The following common
share equivalents, prior to the use of the treasury stock method, have been
excluded from the computation of diluted weighted average shares outstanding as
of September 30, 2007 and 2006, as they would be anti-dilutive.
8
Sirtris
Pharmaceuticals, Inc.
(A
development-stage company)
Notes to Consolidated Financial Statements (Continued)
(
in thousands, except share and per share amounts
)
(Unaudited)
|
|
Three and Nine months Ended
September 30,
|
|
|
|
2007
|
|
2006
|
|
Redeemable
convertible preferred stock
|
|
|
|
16,212,871
|
|
Options outstanding
|
|
2,829,531
|
|
2,520,406
|
|
Unvested
restricted stock under the 2004 Stock Option Plan
|
|
95,236
|
|
184,522
|
|
Unvested
restricted stock issued to founders
|
|
51,211
|
|
111,919
|
|
Warrants
outstanding
|
|
99,465
|
|
99,465
|
|
8.
Commitments
On June 22, 2007, the Company entered into a lease
agreement for approximately 44,000 square feet of office and laboratory space
located in Cambridge, Massachusetts. The target commencement date (Commencement
Date) of the lease is December 1, 2007 and extends for a period of ten
years at an initial annual rental rate of $58.50 per square foot and a minimum
average annual rate of $68.63 per square foot over the lease term. The lease contains annual rent escalation
provisions and the Company will record rent expense on a straight-line basis
over the effective lease term. The
Company has the option to extend the lease for two consecutive additional
five-year periods. The Companys current
lease of approximately 11,500 square feet located at 790 Memorial Drive in
Cambridge, Massachusetts has been amended to terminate on the Commencement
Date, subject to certain written notifications.
The Companys payment
obligations under the lease are secured by a $1.9 million standby letter
of credit. The certificate of deposit that secures the letter of credit is
included in long-term restricted cash on the balance sheet at September 30,
2007.
The Company signed a
lease amendment effective October 30, 2007 for an additional 3,786 square feet
of space at the same location and on the same terms as the June 22, 2007 lease
agreement. In connection with the lease
amendment, the standby letter of credit and corresponding certificate of
deposit were increased to $2.1 million.
9. Common Stock
Reverse Stock Split
On
April 11, 2007, the Companys Board of Directors and stockholders approved a
1-for-5.25 reverse stock split. All
share and per share amounts in the consolidated financial statements have been
retroactively adjusted for all periods presented to give effect to the reverse
stock split, including reclassifying an amount equal to the reduction in par
value to additional paid-in capital.
Initial Public Offering
In
May 2007, the Company raised $69.0 million in gross proceeds from the sale
of 6,900,000 shares of its common stock in an initial public offering
(IPO) at $10.00 per share. The net offering proceeds after deducting
approximately $6.5 million in offering related expenses and underwriters
discounts were approximately $62.5 million. All outstanding shares of the Companys
redeemable convertible preferred stock were converted into 20,287,131 shares of
common stock upon the completion of the IPO.
In connection with the initial public offering, the
Company revalued the warrants for shares subject to repurchase and recorded
additional interest expense of $63.
Warrants for shares subject to repurchase was then reclassified to
additional paid-in capital upon the warrants converting from warrants for the
purchase of shares of redeemable convertible preferred stock to warrants for
the purchase of common stock. The
remaining value of the warrants will be recorded in interest expense and rent
expense, as appropriate, over the remaining term of the notes payable and the
lease in connection with which they were issued.
9
Item 2. Managements Discussion and Analysis of Financial
Condition and Results of Operations
The
following discussion contains forward-looking statements, which involve risks
and uncertainties. Our actual results could differ materially from those
anticipated in these forward-looking statements as a result of various factors
,including those set forth below under Part II, Item 1A, Risk
Factors. The interim financial statements and this Managements Discussion and
Analysis of Financial Condition and Results of Operations should be read in
conjunction with the financial statements and notes thereto for the year ended
December 31, 2006 and the related Managements Discussion and Analysis of
Financial Condition and Results of Operations, both of which are contained in
our Prospectus filed pursuant to Rule 424(b) under the Securities Act with the
Securities and Exchange Commission on May 22, 2007. Except as required by law,
we assume no obligation to update these forward-looking statements, whether as
a result of new information, future events or otherwise.
Overview
We are a
biopharmaceutical company focused on discovering and developing proprietary,
orally available, small molecule drugs with the potential to treat diseases
associated with aging, including metabolic diseases such as Type 2 Diabetes.
Our goal is to successfully develop therapeutics for diseases of aging by
modulating sirtuins, a recently discovered class of enzymes, and their related
pathways. To date, we have devoted substantially all of our resources to our
drug discovery efforts and the development of our drug candidates, including
conducting preclinical studies and clinical trials and seeking protection for
our intellectual property. Since our inception in March 2004, we have had
no revenue from product sales, and have funded our operations principally
through private and public sales of equity securities and debt financings.
We have never been
profitable and, as of September 30, 2007, we have an accumulated deficit of $50.6 million.
We had net losses of $1.8 million for the period from March 25, 2004 (date
of inception) through December 31, 2004, $9.7 million for the year
ended December 31, 2005, $17.0 million for the year ended December 31,
2006 and $22.0 million for the nine months ended September 30, 2007. We
expect to incur significant and increasing operating losses for the foreseeable
future as we advance our product candidates from discovery through preclinical
studies and clinical trials and seek regulatory approval and eventual
commercialization. In addition to these increasing research and development
expenses, we expect general and administrative costs to increase as we add
personnel and continue to operate as a public company. We will need to generate
significant revenues to achieve profitability and may never do so.
Critical
Accounting Policies
We believe that several
accounting policies are important to understanding our historical and future
performance. We refer to these policies as critical because these specific
areas generally require us to make judgments and estimates about matters that
are uncertain at the time we make the estimate, and different estimates - which
also would have been reasonable - could have been used, which would have
resulted in different financial results. It is important that the
discussion of our operating results that follows be read in conjunction with
the critical accounting policies disclosed in our Prospectus filed pursuant to
Rule 424(b) under the Securities Act with the Securities and Exchange
Commission on May 22, 2007. There were no changes to such critical
accounting policies in the three months ended September 30, 2007.
Results
of Operations
Comparison of the Three Months ended September 30, 2007 and
September 30, 2006
Revenue.
We did not record any revenue for the
three months ended September 30, 2007 (2007 Quarter) or the three months ended
September 30, 2006 (2006 Quarter).
Research
and development.
Research
and development expense for the 2007 Quarter was $9.5 million compared to
$4.2 million for the 2006 Quarter. The $5.3 million increase from the 2006
Quarter to the 2007 Quarter principally resulted from an increase of $1.7
million in preclinical studies, an increase of $1.1 million in external clinical
trial costs, an increase of $1.0 million in stock-based compensation expense,
an increase of $598,000 in formulation costs for our product candidates, an
increase of $325,000 in sponsored research costs, an increase of $241,000 in
occupancy and information technology (IT) costs and an increase of $225,000 for
personnel costs related principally to an increase in research and development
headcount.
General
and administrative
. General
and administrative expense for the 2007 Quarter was $1.6 million compared
to $1.1 million for the 2006 Quarter. The $514,000 increase from the 2006
Quarter to the 2007 Quarter was primarily due to an increase of $219,000 in
professional fees primarily as a result of being a public company, an increase
of $128,000 in stock-based compensation expense, an increase of $90,000 in
personnel costs and an increase of $27,000 in occupancy and IT costs.
Interest
income
. Interest
income increased to $1.7 million for the 2007 Quarter from $717,000 for the
2006 Quarter. The increase in interest income was caused by an increase in the
average fund balances available for investment and an
10
increase in interest rates earned on investments. The
increase in the average fund balances for investment was primarily due to the
sale of redeemable convertible preferred stock in January and February of 2007
and the completion of our initial public offering in May 2007.
Interest
expense.
Interest
expense increased to $331,000 for the 2007 Quarter from $295,000 for the 2006
Quarter. The increase in interest expense from the 2006 Quarter to the 2007
Quarter was primarily the result of the drawdown of $10.0 million under a
loan agreement and $797,000 under an equipment loan agreement in April 2006 and
July 2006, respectively. We also recorded $39,000 of non-cash interest
expense related to warrants for the purchase of redeemable convertible
preferred stock that converted into warrants for the purchase of common stock
upon our initial public offering.
Comparison of the Nine Months ended September 30, 2007 and
June 30, 2006
Revenue.
We did not record any revenue for the
nine months ended September 30, 2007 (2007 Period) or the nine months ended
September 30, 2006 (2006 Period).
Research
and development.
Research
and development expense for the 2007 Period was $20.7 million compared to $10.6 million
for the 2006 Period. The $10.1 million increase from the 2006 Period to the
2007 Period principally resulted from an increase of $1.8 million in
stock-based compensation expense, an increase of $1.8 million in external
clinical trial costs, an increase of
$1.5 million in preclinical studies, an increase of $1.0 million for personnel
costs primarily related to an increase in research and development headcount,
an increase of $927,000 in occupancy and IT costs, an increase of $820,000 in
external chemistry and biology costs, an increase of $802,000 in formulation
costs for our product candidates, an increase of $735,000 in sponsored research
costs, an increase of $157,000 in depreciation, and $153,000 in license fees.
General
and administrative
. General
and administrative expense for the 2007 Period was $4.1 million compared
to $3.3 million for the 2006 Period. The $870,000 increase from the 2006
Period to the 2007 Period was primarily due to an increase of $289,000 in
stock-based compensation expense, an increase of $187,000 in personnel costs,
an increase of $99,000 in occupancy and IT costs, an increase of $81,000 in
professional fees primarily as a result of being a public company, and an
increase of $81,000 of bank fees primarily due to fees for a standby letter of
credit related to a new facility and $48,000 in temporary help costs.
Interest
income.
Interest
income increased to $3.9 million for the 2007 Period from $1.7 million for the
2006 Period. The increase in interest income was caused by an increase in the
average fund balances available for investment and an increase in interest
rates earned on investments. The increase in the average fund balances for
investment was primarily due to the sale of redeemable convertible preferred
stock in January and February of 2007 and the completion of our initial public
offering in May 2007.
Interest
expense.
Interest
expense increased to $1.1 million for the 2007 Period from $519,000 from the
2006 Period. The increase in interest expense from the 2006 Period to the 2007
Period was primarily the result of the drawdown of $10.0 million under a
loan agreement and $797,000 under an equipment loan agreement in April 2006 and
July 2006, respectively. We also recorded $177,000 of non-cash interest
expense related to warrants for the purchase of redeemable convertible
preferred stock that converted into warrants for the purchase of common stock upon
our initial public offering.
Liquidity and Capital Resources
Since our inception in
March 2004, we have funded our operations principally through the private
placement of equity securities, which provided aggregate net cash proceeds of
approximately $102.6 million and the completion of an initial public
offering that provided net proceeds of approximately $62.5 million. We have
also generated funds from debt financing and interest income. As of
September 30, 2007, we had cash, cash equivalents and short-term
investments of approximately $127.1 million. Our funds are currently
invested in investment grade and United States government securities.
During the 2007 Period
and 2006 Period, our operating activities used cash of $17.7 million and
$11.3 million, respectively. The use of cash in both periods primarily resulted
from our net losses and changes in our working capital accounts. The increase
in cash used in operations in the 2007 Period was due primarily to an increase
in research and development activities as noted above.
During the 2007 Period
and 2006 Period, our investing activities used cash of $59.7 million and
$2.1 million, respectively. The use of cash in both periods is a result of
purchases of investment grade securities, partially offset by maturities of
such short-term investments. The 2007
Period also used cash for additions to restricted cash to secure a standby
letter of credit for our new facility lease. We expect to have an
increase in capital expenditures of approximately $600,000 during the fourth
quarter of 2007 related to our new facility.
Our financing activities
provided $97.9 million and $32.8 million for the 2007 Period and the
2006 Period, respectively. The cash provided in the 2007 Period resulted from
the sale and issuance of 21.4 million shares of Series C-1 redeemable
convertible preferred stock in January and February 2007 that provided net
proceeds of $35.9 million and from the sale and issuance of 6.9 million shares
of common stock in our initial public offering in May 2007 that provided net
proceeds of $62.5
11
million. The cash
provided in the 2006 Period resulted from the sale and issuance of
19.7 million shares of Series C redeemable convertible preferred
stock in March and April 2006 that provided net proceeds of
$22.0 million and $10.0 million of proceeds from a note payable to a
financial institution.
In April 2006, we
obtained a loan from a financial institution which permitted borrowings of up
to $15.0 million, $10.0 million of which was available immediately
and an additional $5.0 million was available during the third quarter of
2007 when certain clinical milestones were achieved. The additional $5.0
million was not drawn down during the third quarter so there is no remaining
amount available under this loan. We are obligated to make interest-only payments
through July 2007 followed by forty-five equal monthly payments of
principal and interest. The loan is secured by essentially all our assets
except for intellectual property and bears interest at 10.60% per annum. In
April 2006, we borrowed $10.0 million under the loan. As of September
30, 2007, there was $9.6 million outstanding and no remaining amount available
under the loan. In connection with the loan, the lender received a warrant to
purchase up to 127,551 shares of our common stock depending upon the amount
actually borrowed at an exercise price of $5.88 per share. The warrant is
currently exercisable for up to 85,034 shares of our common stock and no
additional shares of our common stock can become exercisable as we cannot make
additional borrowings under this loan. This warrant has not been exercised.
In May 2006, we
entered into an equipment loan agreement with a bank to borrow up to
$1.5 million through March 2007. Amounts borrowed under the facility
are repayable over 36 months beginning in April 2007 and bear
interest at prime plus 0.25% per annum. As of September 30, 2007, there was
$665,000 outstanding and no remaining amount available under the equipment
loan. In connection with the financing, the lender received a warrant to purchase
up to 4,749 shares of our common stock depending upon the amount actually
borrowed at an exercise price of $4.20 per share. The warrant is currently
exercisable for up to 2,526 shares of our common stock while the remaining
2,223 additional shares of our common stock were cancelled since we did not
make any additional borrowings under this loan before March 2007. This
warrant has not been exercised.
We expect our existing
resources to be sufficient to fund our planned operations until at least the
end of 2009.
Contractual
Obligations
On June 22, 2007, we
entered into a commercial lease agreement for approximately 44,000 square feet
of office and laboratory space located in Cambridge, Massachusetts. The target
commencement date (Commencement Date) of the lease is December 1, 2007 and
it extends for a period of ten years at an initial annual rental rate of $58.50
per square foot and a minimum average annual rate of $68.63 per square foot
over the lease term. The lease contains annual rent escalation provisions.
We have the option to extend the lease for two consecutive additional five-year
periods. Our payment obligations under the lease are secured by a
$1.9 million standby letter of credit.
The certificate of deposits that secures the letter of credit is
included in long-term restricted cash on the consolidated balance sheet at
September 30, 2007. Our current lease of approximately 11,500 square
feet located at 790 Memorial Drive in Cambridge, Massachusetts has been amended
to terminate on the Commencement Date, subject to certain written
notifications. Our President and Chief Executive Officer, Christoph Westphal,
performs consulting services for an affiliate of the landlord.
We signed a lease
amendment effective October 30, 2007 for an additional 3,786 square feet of
space at the same location and on the same terms as the June 22, 2007 lease
agreement. In connection with the lease
amendment, the standby letter of credit and corresponding certificate of
deposit were increased to $2.1 million.
There are no other
additional material obligations incurred by us that materially change the
disclosure of our contractual obligations in our Prospectus filed pursuant to
Rule 424(b) under the Securities Act with the Securities and Exchange
Commission on May 22, 2007.
Off-Balance
Sheet Arrangements
We do not have any
off-balance sheet arrangements or relationships with unconsolidated entities of
financial partnerships, such as entities often referred to as structured
finance or special purpose entities.
Item 3. Quantitative and Qualitative Disclosure about Market
Risk
We are exposed to market
risk related to changes in interest rates. As of September 30, 2007, we had
cash, cash equivalents and short-term investments of $127.1 million consisting
of cash and highly liquid short-term investments. Our primary exposure to market risk is
interest income sensitivity, which is affected by changes in the general level
of U.S. interest rates, particularly because our investments are in short-term
marketable securities. Due to the
short-term duration of our investment portfolio and the low risk profile of our
investments, an immediate 10% change in interest rates would not have a
material effect on the fair market value of our portfolio. Our outstanding notes payable are at fixed
interest rates and therefore have minimal exposure to changes in interest
rates.
12
Item 4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
As required by
Rule 13a15(b) of the 1934 Act our management, including the
principal executive officer and the principal financial officer, conducted an
evaluation as of the end of the period covered by this Quarterly Report on
Form 10-Q of the effectiveness of the design and operation of our
disclosure controls and procedures. Based on that evaluation, our principal
executive officer and principal financial officer concluded that our disclosure
controls and procedures are effective at the reasonable assurance level in
ensuring that information required to be disclosed by us in the reports that we
file or submit under the 1934 Act is recorded, processed, summarized and
reported within the time periods specified in the SECs rules and
forms. Disclosure controls and
procedures include, without limitation, controls and procedures designed to
ensure that information required to be disclosed by us in the reports we file
under the Securities and Exchange Act is accumulated and communicated to our
management, including our principal executive officer and principal financial
officer, as appropriate to allow timely decisions regarding required
disclosure.
Changes
in Internal Control
As required by
Rule 13a-15(d) of the 1934 Act, our management, including the
principal executive officer and the principal financial officer, conducted an
evaluation of the internal control over financial reporting to determine
whether any changes occurred during the period covered by this Quarterly Report
on Form 10-Q that have materially affected, or are reasonably likely to
materially affect, our internal control over financial reporting. Based on that
evaluation, the principal executive officer and principal financial officer
concluded no such changes during the fiscal quarter covered by this Quarterly
Report on Form 10-Q materially affected, or were reasonably likely to
materially affect, our internal control over financial reporting.
13
PART II
Item 1. Legal Proceedings
We are currently
not a party to any material legal proceedings.
Item 1a. Risk Factors
RISK
FACTORS THAT MAY AFFECT FUTURE RESULTS
Investment in our common stock
involves a high degree of risk and uncertainty. You should carefully consider
each of the risks and uncertainties described below before you decide to invest
in our common stock. You should also refer to the other information in this
quarterly report, including our financial statements and related notes. If any
of the following risks and uncertainties actually occurs, our business, financial
condition, and results of operations could be severely harmed. This could cause
the trading price of our common stock to decline, and you could lose all or
part of your investment.
Risks related to our discovery,
development and commercialization of new medicines
Our results to date
provide no basis for predicting whether any of our product candidates will be
safe or effective, or receive regulatory approval.
Our only clinical candidate, SRT501, is in an early stage of
development and its risk of failure is high. To date, the data supporting our
drug discovery and development programs, including SRT501 and new chemical
entities, are derived solely from laboratory and preclinical studies and
limited early stage clinical trials. Results in animal studies of SRT501 were
favorable and all of the reported adverse side effects in our early stage
clinical trials were reversible and none were serious. However, additional
clinical trials in humans may not show that our current formulation of SRT501
is safe and effective, in which event we may need to reformulate or abandon
development of SRT501. Reformulation of SRT501 could result in delays and
additional costs. It is impossible to predict when or if SRT501 or any of our
NCEs will prove effective or safe in humans or will receive regulatory
approval. These compounds may not demonstrate in patients the chemical and
pharmacological properties ascribed to them in laboratory studies, or early
stage clinical trials, and they may interact with human biological systems or
other drugs in unforeseen, ineffective or harmful ways. Neither we nor any
other company has received regulatory approval to market therapeutics that
target sirtuins. If we are unable to discover or successfully develop drugs
that are effective and safe in humans, we will not have a viable business.
We may not be able
to initiate and complete preclinical studies and clinical trials for our
product candidates which could adversely affect our business.
We have completed two Phase 1a trials with respect to our only clinical
product candidate, SRT501, both of which were conducted outside of the United
States, and have not commenced any clinical trials for our NCEs. We must
successfully initiate and complete extensive preclinical studies and clinical trials
for our product candidates before we can receive regulatory approval.
Preclinical studies and clinical trials are expensive and will take several
years to complete and may not yield results that support further clinical
development or product approvals. Conducting clinical studies for any of our
drug candidates for approval in the United States requires filing an IND and
reaching agreement with the FDA on clinical protocols, finding appropriate
clinical sites and clinical investigators, securing approvals for such studies
from the institutional review board at each such site, manufacturing clinical
quantities of drug candidates, supplying drug product to clinical sites and
enrolling sufficient numbers of participants. Currently, the IND that we filed
for SRT501 in August 2006 is on hold with the FDA, and we cannot conduct
clinical studies in the Unites States until we satisfactorily respond to
requests from the FDA for certain additional information. In order to commence
clinical trials in the United States, we must reach agreement with the FDA on a
second animal species for preclinical toxicity studies, conduct such studies
and satisfy the FDA with the results of such studies. We cannot guarantee that
we will be able to successfully accomplish these activities or all of the other
activities necessary to initiate and complete clinical trials. As a result, our
preclinical studies and clinical trials may be extended, delayed or terminated,
and we may be unable to obtain regulatory approvals or successfully commercialize
our products.
None of our product
candidates has received regulatory approvals. If we are unable to obtain
regulatory approvals to market one or more of our product candidates, our
business may be adversely affected.
All of our product candidates are in early stages of development, and
we do not expect our product candidates to be commercially available for
several years, if at all. Our product candidates are subject to strict
regulation by regulatory authorities in the United States and in other
countries. We cannot market any product candidate until we have completed all
necessary preclinical studies and clinical trials and have obtained the
necessary regulatory approvals. We do not know whether regulatory agencies will
grant approval for any of our product candidates. Even if we complete
preclinical studies and clinical trials successfully, we may not be able to
obtain regulatory approvals or we may not receive approvals to make claims
about our products that we believe to be necessary to effectively market our
products. Data obtained from preclinical studies and clinical trials are
subject to varying interpretations that could delay,
14
limit or prevent regulatory approval, and failure to comply with
regulatory requirements or inadequate manufacturing processes are examples of
other problems that could prevent approval. In addition, we may encounter
delays or rejections due to additional government regulation from future
legislation, administrative action or changes in the FDA policy. Even if the
FDA approves a product, the approval will be limited to those indications
covered in the approval.
Outside the United States, our ability to market any of our potential
products is dependent upon receiving marketing approvals from the appropriate
regulatory authorities. These foreign regulatory approval processes include all
of the risks associated with the FDA approval process described above. If we
are unable to receive regulatory approvals, we will be unable to commercialize
our product candidates, and our business may fail.
We may not be able
to gain market acceptance of our product candidates, which would prevent us
from becoming profitable.
We cannot be certain that any of our product candidates will gain
market acceptance among physicians, patients, healthcare payers, pharmaceutical
companies or others. Demonstrating the safety and efficacy of our product
candidates and obtaining regulatory approvals will not guarantee future
revenue. Sales of medical products largely depend on the reimbursement of
patients medical expenses by government healthcare programs and private health
insurers. Governments and private insurers closely examine medical products to
determine whether they should be covered by reimbursement and if so, the level
of reimbursement that will apply. We cannot be certain that third party payers
will sufficiently reimburse sales of our products, or enable us to sell our
products at profitable prices. Similar concerns could also limit the
reimbursement amounts that health insurers or government agencies in other
countries are prepared to pay for our products. In many countries where we plan
to market our products, including Europe, Japan and Canada, the pricing of
prescription drugs is controlled by the government or regulatory agencies.
Regulatory agencies in these countries could determine that the pricing for our
products should be based on prices of other commercially available drugs for
the same disease, rather than allowing us to market our products at a premium
as new drugs.
Sales of medical products also depend on physicians willingness to
prescribe the treatment, which is likely to be based on a determination by
these physicians that the products are safe, therapeutically effective and
cost-effective. We cannot predict whether physicians, other healthcare
providers, government agencies or private insurers will determine that our
products are safe, therapeutically effective and cost effective relative to
competing treatments.
Our current product
candidates are SIRT1 activators. Resveratrol, a SIRT1 activator, is marketed by
other companies as a dietary supplement. As a result, any products we
successfully develop may be subject to substitution and competition.
SRT501, a proprietary formulation of resveratrol, and our NCEs activate
SIRT1. Resveratrol, a naturally occurring substance currently marketed by
others as a dietary supplement, also activates SIRT1. We believe that our
product candidates will have a significantly superior therapeutic profile to
resveratrol based on preclinical data regarding the level of resveratrol in the
blood and the effectiveness of these product candidates in reducing fasted
glucose levels and fed insulin levels in animals. However, we cannot be sure
that physicians will view our product candidates as superior to currently
available dietary supplements. To the extent that the price of any product
candidate we successfully develop is significantly higher than the prices of
commercially available resveratrol as marketed by other companies as dietary
supplements, physicians may recommend this commercially available resveratrol
instead of writing prescriptions for our products or patients may elect on
their own to take commercially available resveratrol, and this may limit how we
price our product.
We may not be able
to manufacture our product candidates in clinical or commercial quantities,
which would prevent us from commercializing our product candidates.
To date, our product candidates have been manufactured in small
quantities by us and third party manufacturers for preclinical studies and
clinical trials. If any of our product candidates is approved by the FDA or
other regulatory agencies for commercial sale, we will need to manufacture it
in larger quantities and we intend to use third party manufacturers for
commercial quantities. Our third party manufacturers may not be able to
successfully increase the manufacturing capacity for any of our product
candidates in a timely or efficient manner, or at all. If we are unable to
successfully increase the manufacturing capacity for a product candidate, the
regulatory approval or commercial launch of that product candidate may be
delayed or there may be a shortage in the supply of the product candidate. Our
failure or the failure of our third party manufacturers to comply with the FDAs
good manufacturing practices and to pass inspections of the manufacturing
facilities by the FDA or other regulatory agencies could seriously harm our
business.
We may not be able
to obtain and maintain the third party relationships that are necessary to
develop, commercialize and manufacture some or all of our product candidates.
We expect to depend on collaborators, partners, licensees, clinical
research organizations, manufacturers and other third parties to support our
discovery efforts, to formulate product candidates, to conduct clinical trials
for some or all of our product candidates, to manufacture clinical and
commercial scale quantities of our product candidates and products and to
market, sell, and distribute any products we successfully develop.
15
We cannot guarantee that we will be able to successfully negotiate
agreements for or maintain relationships with collaborators, partners,
licensees, clinical investigators, manufacturers and other third parties on
favorable terms, if at all. If we are unable to obtain or maintain these
agreements, we may not be able to clinically develop, formulate, manufacture,
obtain regulatory approvals for or commercialize our product candidates, which
will in turn adversely affect our business.
We expect to expend substantial management time and effort to enter
into relationships with third parties and, if we successfully enter into such
relationships, to manage these relationships. In addition, substantial amounts
of our expenditures will be paid to third parties in these relationships.
However, we cannot control the amount or timing of resources our contract
partners will devote to our research and development programs, product
candidates or potential product candidates, and we cannot guarantee that these
parties will fulfill their obligations to us under these arrangements in a
timely fashion, if at all.
In particular, we currently have approximately 40 contract scientists
performing research and development services for us in a contract research
organization in China. The loss of this contractual relationship could result
in a significant delay and additional costs for our discovery and development
activities. In addition, we are less knowledgeable about the reputation and
quality of third party contractors in countries outside of the United States
where we conduct discovery and clinical development programs and, therefore,
enter into these relationships with less information than if these third
parties were in the United States and may not choose the best parties for these
relationships.
We have no
experience in sales, marketing and distribution and may have to enter into
agreements with third parties to perform these functions, which could prevent
us from successfully commercializing our product candidates.
We currently have no sales, marketing or distribution capabilities. To
commercialize our product candidates, we must either develop our own sales,
marketing and distribution capabilities, which will be expensive and time
consuming, or make arrangements with third parties to perform these services
for us. If we decide to market any of our products on our own, we will have to
commit significant resources to developing a marketing and sales force and
supporting distribution capabilities. If we decide to enter into arrangements
with third parties for performance of these services, we may find that they are
not available on terms acceptable to us, or at all. If we are not able to
establish and maintain successful arrangements with third parties or build our
own sales and marketing infrastructure, we may not be able to commercialize our
product candidates which would adversely affect our business and financial
condition.
If we were to elect
to commercialize SRT501 as a dietary supplement, we may not be able to
successfully market one or more of our NCEs as a therapy for disease, if
approved, and our results may be adversely affected.
Resveratrol is currently available for sale by other companies as
dietary supplements. If we were to elect to market SRT501 as a dietary
supplement, which we may do if we discontinue development of SRT501 as a
therapeutic drug, we believe we could do so without the need to complete
lengthy and costly clinical trials. If we were to obtain regulatory approval
for one of our NCEs, we anticipate that we would price the NCE at a
considerably higher level than SRT501 would be priced if we were selling SRT501
as a dietary supplement. While our NCEs are chemical entities distinct from
SRT501 and resveratrol, patients suffering from diseases for which our NCEs may
be approved for treatment may choose to use the lower priced SRT501 dietary
supplement, since it also activates SIRT1, rather than the higher priced
approved NCE prescription product. As a result, if we choose to commercialize
SRT501 as a dietary supplement, our ability to successfully commercialize NCE
activators of SIRT1 may be adversely affected.
We may fail to
select or capitalize on the most scientifically, clinically or commercially
promising or profitable product candidates.
We have limited technical, managerial and financial resources to
determine which of our product candidates should proceed to initial clinical
trials, later stage clinical development and potential commercialization. We
may make incorrect determinations. Our decisions to allocate our research and
development, management and financial resources toward particular product
candidates or therapeutic areas may not lead to the development of viable
commercial products and may divert resources from better opportunities.
Similarly, our decisions to delay or terminate drug development programs may
also be incorrect and could cause us to miss valuable opportunities.
If we are not able
to retain our current senior management team and our scientific advisors or
continue to attract and retain qualified scientific, technical and business
personnel, our business will suffer.
We are dependent on the members of our management team and our
scientific advisors for our business success. An important element of our
strategy is to take advantage of the research and development expertise of our
current management and to utilize the unique expertise of our scientific
advisors in the sirtuin field. We currently have employment agreements with all
of our executive officers. Our employment agreements with our executive
officers are terminable on short notice or no notice and provide for severance
and change of control benefits. The loss of any one of our executive officers
or key scientific consultants, including, in particular, Dr. Christoph
Westphal, our Chief Executive Officer, could result in a significant loss in
the knowledge and experience that we, as an organization, possess and could
cause significant delays, or outright failure, in the development and further
commercialization of our product candidates.
16
To grow, we will need to hire a significant number of qualified
commercial, scientific and administrative personnel. However, there is intense
competition for human resources, including management in the technical fields
in which we operate, and we may not be able to attract and retain qualified
personnel necessary for the successful development and commercialization of our
product candidates. Our inability to attract new employees or to retain
existing employees could limit our growth and harm our business.
Disputes under key
agreements or conflicts of interest with our scientific advisors or clinical
investigators could delay or prevent development or commercialization of our
product candidates.
Any agreements we have or may enter into with third parties, such as
collaboration, license, formulation supplier, manufacturing, clinical research
organization or clinical trial agreements, may give rise to disputes regarding
the rights and obligations of the parties. Disagreements could develop over
rights to ownership or use of intellectual property, the scope and direction of
research and development, the approach for regulatory approvals or
commercialization strategy. We intend to conduct research programs in a range
of therapeutic areas, but our pursuit of these opportunities could result in
conflicts with the other parties to these agreements who may be developing or
selling pharmaceuticals or conducting other activities in these same
therapeutic areas. Any disputes or commercial conflicts could lead to the
termination of our agreements, delay progress of our product development
programs, compromise our ability to renew agreements or obtain future
agreements, lead to the loss of intellectual property rights or result in
costly litigation.
We collaborate with outside scientific advisors and collaborators at academic
and other institutions that assist us in our research and development efforts.
Our scientific advisors are not our employees and may have other commitments
that limit their availability to us. If a conflict of interest between their
work for us and their work for another entity arises, we may lose their
services.
We may encounter
difficulties in managing our growth, which could adversely affect our
operations.
Since our inception in 2004, we have grown to approximately 50
employees. We have experienced a period of rapid growth that has placed a
strain on our administrative and operational infrastructure. We expect this
strain to continue as we continue to grow and seek to obtain and manage
relationships with third parties. Our ability to manage our operations and
growth effectively depends upon the continual improvement of our procedures,
reporting systems, and operational, financial, and management controls. We may
not be able to implement improvements in an efficient or timely manner and may
discover deficiencies in existing systems and controls. If we do not meet these
challenges, we may be unable to take advantage of market opportunities, execute
our business strategies or respond to competitive pressures which in turn may
slow our growth or give rise to inefficiencies that would increase our losses.
We may acquire additional technology and complementary businesses in
the future. Acquisitions involve many risks, any one of which could materially
harm our business, including the diversion of managements attention from core
business concerns, failure to exploit acquired technologies, or the loss of key
employees from either our business or the acquired business.
Risks related to our financial
results and need for additional financing
We have a history
of operating losses, expect to incur significant and increasing operating
losses and may never be profitable.
We were incorporated in March 2004 and have a very limited
operating history for you to evaluate our business. We have no approved products
and have generated no product revenue. We have incurred operating losses since
our inception in 2004. As of September 30, 2007, we had an accumulated deficit
of $50.6 million. We have spent,
and expect to continue to spend, significant resources to fund research and
development of our product candidates. We expect to incur substantial and
increasing operating losses over the next several years as our research,
development, preclinical testing, and clinical trial activities increase. As a
result, our accumulated deficit will also increase significantly.
Our product candidates are in the early stages of development and may
never result in any revenue. We will not be able to generate product revenue
unless and until one of our product candidates successfully completes clinical
trials and receives regulatory approval. As our most advanced product
candidates are at an early proof-of-concept stage, we do not expect to receive
revenue from any product candidate for the foreseeable future. We may seek to
obtain revenue from collaboration or licensing agreements with third parties.
We currently have no such agreements which will provide us with material,
ongoing future revenue and we may never enter into any such agreements. Even if we eventually generate revenues, we
may never be profitable, and if we do achieve profitability, we may not be able
to sustain or increase profitability on a quarterly or annual basis.
We may be unable to
raise the substantial additional capital that we will need to sustain our
operations.
We will need substantial additional funds to support our planned
operations. Based on our current operating plans, we expect our existing
resources to be sufficient to fund our planned operations until at least the
end of 2009. We may, however, need to raise additional funds before that date
if our research and development expenses exceed our current expectations. This
could occur for many reasons, including:
some or all of our product candidates fail in clinical or preclinical
studies and we are forced to seek additional product candidates;
17
our product candidates require more extensive clinical or preclinical
testing than we currently expect;
we advance more of our product candidates than expected into costly
later stage clinical trials;
we advance more preclinical product candidates than expected into early
stage clinical trials;
we are required, or consider it advisable, to acquire or license rights
from one or more third parties; or
we acquire or license rights to additional product candidates or new
technologies.
While we expect to seek additional funding through public or private
financings, we may not be able to obtain financing on acceptable terms, or at
all. In addition, the terms of our financings may be dilutive to, or otherwise
adversely affect, holders of our common stock. We may also seek additional
funds through arrangements with collaborators or other third parties. These
arrangements would generally require us to relinquish rights to some of our
technologies, product candidates or products, and we may not be able to enter
into such agreements, on acceptable terms, if at all. These arrangements also
may include issuances of equity, which may also be dilutive to, or otherwise
adversely affect, holders of our common stock.
If we are unable to obtain additional funding on a timely basis, we may
be required to curtail or terminate some or all of our research or development
programs, including some or all of our product candidates.
Risks related to regulatory approvals
Our product
candidates must undergo rigorous clinical trials and regulatory approvals,
which could delay or prevent commercialization of our product candidates.
All of our product candidates will be subject to rigorous and extensive
clinical trials and extensive regulatory approval processes implemented by the
FDA and similar regulatory bodies in other countries. The approval process is
typically lengthy and expensive, and approval is never certain. We or our collaborators,
if any, may delay, suspend or terminate clinical trials at any time for reasons
including:
ongoing discussions with the FDA or comparable foreign authorities
regarding the scope or design of our clinical trials;
delays or the inability to obtain required approvals from institutional
review boards or other governing entities at clinical sites selected for
participation in our clinical trials;
delays in enrolling patients and volunteers into clinical trials;
lower than anticipated retention rates of patients and volunteers in
clinical trials;
the need to repeat clinical trials as a result of inconclusive or
negative results or poorly executed testing;
insufficient supply or deficient quality of product candidate materials
or other materials necessary to conduct our clinical trials;
unfavorable FDA inspection and review of a clinical trial site or
records of any clinical or preclinical investigation;
serious and unexpected drug-related side effects or adverse device
effects experienced by participants in our clinical trials; or
the placement of a clinical hold on a trial.
The use of commercially available resveratrol could adversely affect
our development or the approval of SRT501, which is our proprietary formulation
of resveratrol, if any adverse side effects become associated with such
commercially available resveratrol products. Such use could also adversely
affect our ability to market and commercialize our product candidates.
Positive or timely results from preclinical studies and early clinical
trials do not ensure positive or timely results in late stage clinical trials
or product approval by the FDA or any other regulatory authority. Product
candidates that show positive preclinical or early clinical results often fail
in later stage clinical trials. Data obtained from preclinical and clinical
activities is susceptible to varying interpretations, which could delay, limit,
or prevent regulatory approvals.
We have limited experience in conducting the clinical trials required
to obtain regulatory approval. We may not be able to conduct
18
clinical trials at preferred sites, enlist clinical investigators,
enroll sufficient numbers of participants, or begin or successfully complete
clinical trials in a timely fashion, if at all. Any failure to perform may
delay or terminate the trials. Our current clinical trials may be insufficient
to demonstrate that our potential products will be active, safe, or effective.
Additional clinical trials may be required if clinical trial results are
negative or inconclusive, which will require us to incur additional costs and
significant delays. If we do not receive the necessary regulatory approvals, we
will not be able to generate product revenues and may not become profitable.
The regulatory
approval process is costly and lengthy and we may not be able to successfully
obtain all required regulatory approvals.
The preclinical development, clinical trials, manufacturing, marketing
and labeling of pharmaceuticals are all subject to extensive regulation by
numerous governmental authorities and agencies in the United States and other
countries. We must obtain regulatory approval for each of our product
candidates before marketing or selling any of them. It is not possible to
predict how long the approval processes of the FDA or any other applicable
federal or foreign regulatory authority or agency for any of our products will
take or whether any such approvals ultimately will be granted. The FDA and
foreign regulatory agencies have substantial discretion in the drug approval
process, and positive results in preclinical testing or early phases of
clinical studies offer no assurance of success in later phases of the approval
process. Generally, preclinical and clinical testing of products can take many
years and require the expenditure of substantial resources, and the data
obtained from these tests and trials can be susceptible to varying
interpretations that could delay, limit or prevent regulatory approval. If we
encounter significant delays in the regulatory process that result in excessive
costs, this may prevent us from continuing to develop our product candidates.
Any delay in obtaining, or failure to obtain, approvals could adversely affect
the marketing of our products and our ability to generate product revenue. The
risks associated with the approval process include:
failure of our product candidates to meet a regulatory agencys
requirements for safety, efficacy and quality;
limitation on the indicated uses for which a product may be marketed;
unforeseen safety issues or side effects; and
governmental or regulatory delays and changes in regulatory
requirements and guidelines.
We filed for Orphan Drug status for SRT501 for MELAS in the United
States and the European Union. The FDA and the European Union regulatory
authorities grant Orphan Drug designation to drugs intended to treat a rare
disease or condition, which is generally a disease or condition that affects
fewer than 200,000 individuals in the United States and fewer than 5 in 10,000
individuals in the European Union. In the United States, a product that has
Orphan Drug designation and receives the first FDA approval for the disease,
for which it has such designation, is entitled to market exclusivity, except in
very limited circumstances, for seven years. However, if a competitor has
Orphan Drug status for its own product and is first to obtain approval of the
same drug, as defined by the FDA, for the Orphan Drug indication, or if our
product candidate is determined to be contained within the competitors product
for the same indication or disease, then that competitor would have market
exclusivity and approval of our product for that indication or disease could
potentially be blocked for seven years. Orphan Drug designation does not convey
any advantage in, or shorten the duration of, the regulatory review and
approval process. Obtaining Orphan Drug designation may not provide us with a
material commercial advantage.
Even if we receive
regulatory approvals for marketing our product candidates, if we fail to comply
with continuing regulatory requirements, we could lose our regulatory
approvals, and our business would be adversely affected.
The FDA and other regulatory authorities continue to review products
even after they receive initial approval. If we receive approval to
commercialize any product candidates, the manufacturing, testing, marketing,
sale and distribution of these drugs will be subject to continuing regulation,
including compliance with quality systems regulations, good manufacturing
practices, adverse event requirements, and prohibitions on promoting a product
for unapproved uses. Enforcement actions resulting from our failure to comply
with government and regulatory requirements could result in fines, suspension
of approvals, withdrawal of approvals, product recalls, product seizures,
mandatory operating restrictions, criminal prosecution, civil penalties and
other actions that could impair the manufacturing, testing, marketing, sale and
distribution of our potential products and our ability to conduct our business.
Even if we are able
to obtain regulatory approvals for any of our product candidates, if they
exhibit harmful side effects after approval, our regulatory approvals could be
revoked or otherwise negatively impacted, and we could be subject to costly and
damaging product liability claims.
Even if we receive regulatory approval for SRT501 or any of our NCEs,
we will have tested them in only a small number of patients during our clinical
trials. If our applications for marketing are approved and more patients begin
to use our product, new risks and side effects associated with our products may
be discovered. As a result, regulatory authorities may revoke their approvals;
we may be required to conduct additional clinical trials, make changes in
labeling of our product, reformulate our product or make changes and obtain new
approvals for our and our suppliers manufacturing facilities. We might have to
withdraw or recall our products from the
19
marketplace. We may also experience a significant drop in the potential
sales of our product if and when regulatory approvals for such product are
obtained, experience harm to our reputation in the marketplace or become
subject to lawsuits, including class actions. Any of these results could
decrease or prevent any sales of our approved product or substantially increase
the costs and expenses of commercializing and marketing our product.
Healthcare reform
measures could adversely affect our business.
The efforts of governmental and third-party payers to contain or reduce
the costs of healthcare may adversely affect the business and financial
condition of pharmaceutical companies. In the United States and in foreign
jurisdictions there have been, and we expect that there will continue to be, a
number of legislative and regulatory proposals aimed at changing the healthcare
system. For example, in some countries other than the United States, pricing of
prescription drugs is subject to government control, and we expect proposals to
implement similar controls in the United States to continue. The pendency or
approval of such proposals could result in a decrease in our common stock price
or limit our ability to raise capital or to enter into collaborations or
license rights to our products.
New federal
legislation may increase the pressure to reduce prices of pharmaceutical
products paid for by Medicare, which could adversely affect our revenues, if
any.
The Medicare Prescription Drug Improvement and Modernization Act of
2003, or MMA, expanded Medicare coverage for drug purchases by the elderly and
disabled beginning in 2006. The new legislation uses formularies, preferred
drug lists and similar mechanisms that may limit the number of drugs that will
be covered in any therapeutic class or reduce the reimbursement for some of the
drugs in a class.
As a result of the expansion of legislation and the expansion of
federal coverage of drug products, we expect that there will be additional
pressure to contain and reduce costs. Indeed, legislation that would permit the
federal government to negotiate drug prices directly with manufacturers under
the Medicare prescription drug programs is currently under consideration. These
cost reduction initiatives could decrease the coverage and price that we
receive for our products in the future and could seriously harm our business.
While the MMA applies only to drug benefits for Medicare beneficiaries, private
payers often follow Medicare coverage policy and payment limitations in setting
their own reimbursement systems, and any limits on or reductions in
reimbursement that occur in the Medicare program may result in similar limits
on or reductions in payments from private payers.
New federal laws or
regulations on drug importation could make lower cost versions of our future
products available, which could adversely affect our revenues, if any.
The prices of some drugs are lower in other countries than in the
United States because of government regulation and market conditions. Under
current law, importation of drugs into the United States is generally not
permitted unless the drugs are approved in the United States and the entity
that holds that approval consents to the importation. Various proposals have
been advanced to permit the importation of drugs from other countries to
provide lower cost alternatives to the products available in the United States.
In addition, the MMA requires the Secretary of Health and Human Services to
promulgate regulations for drug reimportation from Canada into the United
States under some circumstances, including when the drugs are sold at a lower
price than in the United States.
If the laws or regulations are changed to permit the importation of
drugs into the United States in circumstances that are currently not permitted,
such a change could have an adverse effect on our business by making available
lower priced alternatives to our future products.
Failure to obtain
regulatory and pricing approvals in foreign jurisdictions could delay or
prevent commercialization of our products abroad.
If we succeed in developing any products, we intend to market them in
the European Union and other foreign jurisdictions. In order to do so, we must
obtain separate regulatory approvals and comply with numerous and varying
regulatory requirements. The approval procedure varies among countries and can
involve additional testing. The time required to obtain approval abroad may
differ from that required to obtain FDA approval. The foreign regulatory
approval process may include all of the risks associated with obtaining FDA
approval and additional risks associated with requirements particular to those
foreign jurisdictions where we will seek regulatory approval of our products.
We may not obtain foreign regulatory approvals on a timely basis, if at all.
Approval by the FDA does not ensure approval by regulatory authorities in other
countries, and approval by one foreign regulatory authority does not ensure
approval by regulatory authorities in other foreign countries or by the FDA. We
and our collaborators may not be able to file for regulatory approvals and may
not receive necessary approvals to commercialize our products in any market
outside the United States. The failure to obtain these approvals could
materially adversely affect our business, financial condition and results of
operations.
Risks related to our intellectual
property
Our success depends
upon our ability to obtain and maintain intellectual property protection for
our products and technologies.
20
Our success will depend on our ability to obtain and maintain adequate
protection of our intellectual property covering any products or product
candidates we plan to develop. In addition to taking other steps to protect our
intellectual property, we intend to apply for patents with claims covering our
technologies, processes, products and product candidates when and where we deem
it appropriate to do so. We have applied for patent protection, with claims
directed at mechanism and methods relating to our product candidates, SRT501
formulations, our NCEs and several of our drug discovery tools in the United
States, and in some, but not all, foreign countries. Any changes we make to the
SRT501 formulations may not be covered by our existing patent applications
which would require us to file new applications or seek other forms of
protection. In addition, resveratrol, the active ingredient in SRT501, our most
advanced product candidate, cannot be protected by a patent covering its
chemical composition of matter since resveratrol has long been in the public
domain. Consequently, we are relying on method of use and formulation patent
protection for SRT501, which may not provide the same level of protection as
composition of matter patent protection. In countries where we have not and do
not seek patent protection, third parties may be able to manufacture and sell
our products without our permission, and we may not be able to stop them from
doing so.
Similar to other biotechnology companies, our patent position is
generally uncertain and involves complex legal and factual questions. In
addition, the laws of some foreign countries do not protect proprietary rights
to the same extent as the laws of the United States, and other biotechnology
companies have encountered significant problems in protecting and defending
their proprietary rights in foreign jurisdictions. Whether filed in the United
States or abroad, our patent applications may be challenged or may fail to
result in issued patents. In addition, our existing patents and any future
patents we obtain may not be sufficiently broad to prevent others from
practicing our technologies or from developing or commercializing competing
products. Furthermore, others may independently develop or commercialize
similar or alternative technologies or drugs, or design around our patents. Our
patents may be challenged, invalidated or fail to provide us with any
competitive advantages.
We have licensed some patents on a non-exclusive basis which means such
patents could, now or in the future, potentially be licensed to our competitors
as well, and we may not be able to control or influence the prosecution or
enforcement of such patents. We also may not have unilateral control over the
prosecution and enforcement of our exclusively licensed patents, and our
ability to protect our products using such patents may depend to some extent on
the cooperation of our licensors.
If we do not obtain or we are unable to maintain adequate patent or
trade secret protection for our products in the United States, competitors
could duplicate them without repeating the extensive testing that we will be
required to undertake to obtain approval of the products by the FDA. Regardless
of any patent protection, under the current statutory framework the FDA is
prohibited by law from approving any generic version of any of our products for
three years after it has approved our product. Upon the expiration of that
period, or if that time period is altered, the FDA could approve a generic
version of our product unless we have patent protection sufficient for us to
block that generic version. Without sufficient patent protection, the applicant
for a generic version of our product would be required only to conduct a
relatively inexpensive study to show that its product is bioequivalent to our
product and would not have to repeat the studies that we conducted to
demonstrate that the product is safe and effective. In the absence of adequate
patent protection in other countries, competitors may similarly be able to
obtain regulatory approval in those countries of products that duplicate our
products.
A significant portion of our discovery and development efforts is
performed in China and other countries outside of the United States through
third party contractors. We may not be able to effectively monitor and assess
intellectual property developed by these contractors and may therefore not
appropriately protect this intellectual property and lose valuable intellectual
property rights. In addition, the legal protection afforded to inventors and
owners of intellectual property in countries outside of the United States may
not be as protective of intellectual property rights as in the United States,
and we may, therefore, be unable to acquire and protect intellectual property
developed by these contractors to the same extent as if these discovery and
development activities were being conducted in the United States.
We may be unable to
in-license intellectual property rights or technology necessary to develop and
commercialize our products.
Several third parties are actively researching and seeking patents and
have obtained issued patents in the sirtuin field. Such patents being sought by
third parties include published applications that are directed to the use of
activators of SIRT1, which include claims that, if issued as published, could
encompass SRT501. Although we do not believe that these applications support
patentable claims that would cover our product candidates, including SRT501, we
cannot assure you that such claims will be denied by the patent office. In addition, we are aware of one issued
patent covering the composition of matter of resveratrol and which may cover
SRT501. Depending on what patents
ultimately issue and depending on the ultimate formulation and method of use of
our product candidates, including SRT501 and whether the validity of the issued
patent of which we are aware is maintained, we may need to obtain a license
under such patents or other intellectual property rights. There can be no
assurance that such licenses will be available on commercially reasonable
terms, or at all. If a third party does not offer us a necessary license or
offers a license only on terms that are unattractive or unacceptable to us, we
might be unable to develop and commercialize one or more of our product
candidates.
Moreover, if we fail to meet our obligations under our license agreements,
or our agreements are terminated for any other reasons, we may lose our rights
to in-licensed technologies.
21
Confidentiality
agreements with employees and others may not adequately prevent disclosure of
trade secrets and other proprietary information.
In our activities, we rely substantially upon proprietary materials,
information, trade secrets and know-how to conduct our research and development
activities, and to attract and retain collaborators, licensees and customers.
Our scientific advisors and collaborators gain access to valuable proprietary
knowledge through their activities in collaboration with us. We take steps to
protect our proprietary rights and information, including the use of
confidentiality and other agreements with our employees and consultants and in
our academic and commercial relationships. However, these steps may be
inadequate, agreements may be violated, or there may be no adequate remedy
available for a violation of an agreement. We cannot assure you that our
proprietary information will not be disclosed or that we can meaningfully
protect our trade secrets. Our competitors may independently develop
substantially equivalent proprietary information or may otherwise gain access
to our trade secrets, which could adversely affect our ability to compete in
the market.
Litigation or third
party claims of intellectual property infringement could require substantial
time and money to resolve. Unfavorable outcomes in these proceedings could
limit our intellectual property rights and our activities.
We may need to resort to litigation to enforce or defend our
intellectual property rights, including any patents issued to us. If a
competitor or collaborator files a patent application claiming technology also
invented by us, in order to protect our rights, we may have to participate in
an expensive and time consuming interference proceeding before the United
States Patent and Trademark Office. We cannot guarantee that our product
candidates will be free of claims by third parties alleging that we have
infringed their intellectual property rights. Third parties may assert that we
are employing their proprietary technologies without authorization and they may
resort to litigation to attempt to enforce their rights. Third parties may have
or obtain patents in the future and claim that the use of our technology or any
of our product candidates infringes their patents. We may not be able to
develop or commercialize product candidates because of patent protection others
have. Our business will be harmed if we cannot obtain a necessary or desirable
license, can obtain such a license only on terms we consider to be unattractive
or unacceptable, or if we are unable to redesign our product candidates or
processes to avoid actual or potential patent or other intellectual property
infringement. Obtaining, protecting and defending patent and other intellectual
property rights can be expensive and may require us to incur substantial costs,
including the diversion of management and technical personnel. An unfavorable
ruling in patent or intellectual property litigation could subject us to
significant liabilities to third parties, require us to cease developing,
manufacturing or selling the affected products or using the affected processes,
require us to license the disputed rights from third parties, or result in
awards of substantial damages against us.
There can be no assurance that we would prevail in any intellectual
property infringement action, will be able to obtain a license to any third
party intellectual property on commercially reasonable terms, successfully
develop non-infringing alternatives on a timely basis, or license
non-infringing alternatives, if any exist, on commercially reasonable terms.
Any significant intellectual property impediment to our ability to develop and
commercialize our products could seriously harm our business and prospects.
Patent litigation
or other litigation in connection with our intellectual property rights may
lead to publicity that may harm our reputation and the market price of our
common stock may decline.
During the course of any patent litigation, there may be public announcements
of the results of hearings, motions, and other interim proceedings or
developments in the litigation. If securities analysts or investors regard
these announcements as negative, the market price of our common stock may
decline. General proclamations or statements by key public figures may also
have a negative impact on the perceived value of our intellectual property.
Risks related to our industry
Our competitors and
potential competitors may develop products and technologies that make ours less
attractive or obsolete.
Many companies, universities, and research organizations developing
competing product candidates have greater resources and significantly greater
experience in financial, research and development, manufacturing, marketing,
sales, distribution, and technical regulatory matters than we have. In
addition, many competitors have greater name recognition and more extensive
collaborative relationships. Our competitors could commence and complete
clinical testing of their product candidates, obtain regulatory approvals, and
begin commercial-scale manufacturing of their products faster than we are able
to for our products. They could develop products that would render our product
candidates, and those of our collaborators, obsolete and noncompetitive. If we
are unable to compete effectively against these companies, then we may not be
able to commercialize our product candidates or achieve a competitive position
in the market. This would adversely affect our ability to generate revenues.
Competition in the
biotechnology and pharmaceutical industries may result in competing products,
superior marketing of other products and lower revenues or profits for us.
There are many companies that are seeking to develop products and
therapies for the treatment of diabetes and other metabolic disorders. Our
competitors include multinational pharmaceutical and chemical companies, specialized
biotechnology firms and
22
universities and other research institutions. A number of
pharmaceutical companies, including Abbott, AstraZeneca, Bayer, Bristol-Myers
Squibb, GlaxoSmithKline, Johnson & Johnson, Lilly, Merck, Novartis,
Novo Nordisk, Pfizer, Roche, Sanofi-Aventis, Takeda and Wyeth, as well as large
and small biotechnology companies such as Amgen, Amylin, Genentech and
MannKind, are pursuing the development or marketing of pharmaceuticals that
target the same diseases that we are targeting, and it is possible that the
number of companies seeking to develop products and therapies for the treatment
of diabetes and other metabolic disorders will increase. We are also aware of
other companies, including Elixir Pharmaceuticals and Pharmion Corp that are
seeking to develop drugs that modulate sirtuins. Many of our competitors have
substantially greater financial, technical, human and other resources than we
do and may be better equipped to develop, manufacture and market
technologically superior products. In addition, many of these competitors have
significantly greater experience than we do in undertaking preclinical testing
and human clinical studies of new pharmaceutical products and in obtaining
regulatory approvals of human therapeutic products. Accordingly, our
competitors may succeed in obtaining FDA approval for superior products.
Other products are currently in development or exist in the market that
may compete directly with the products that we are developing or marketing.
Various other products to treat Type 2 Diabetes are available or are in
development, including:
Biguanides;
Sulfonylureas;
Thiazolidinediones (TZDs);
Alpha-glucosidase inhibitors (AGIs);
Dipeptidyl peptidase 4 (DPP4) inhibitors;
Glucagon-like peptide-1 (GLP-1) analogues; and
Insulins, including injectable and inhaled versions.
In addition, several companies are developing various approaches to
improve treatments for Type 1 and Type 2 Diabetes. We cannot predict whether
any products we successfully develop will have sufficient advantages to cause
health care professionals to adopt them over our competitors products or that
our products will offer an economically feasible alternative to our competitors
products. Our potential products could become obsolete before we recover
expenses incurred in developing them.
We may have
significant product liability exposure which may harm our business and our
reputation.
We face exposure to product liability and other claims if our product
candidates, products or processes are alleged to have caused harm. These risks
are inherent in the testing, manufacturing, and marketing of human therapeutic
products. Although we currently maintain product liability insurance in the
amount of $3.0 million, we may not have sufficient insurance coverage, and
we may not be able to obtain sufficient coverage at a reasonable cost, if at
all. Our inability to obtain product liability insurance at an acceptable cost
or to otherwise protect against potential product liability claims could
prevent or inhibit the commercialization of any products or product candidates
that we develop. If we are sued for any injury caused by our products, product
candidates or processes, our liability could exceed our product liability
insurance coverage and our total assets. Claims against us, regardless of their
merit or potential outcome, may also generate negative publicity or hurt our
ability to obtain physician endorsement of our products or expand our business.
We use and generate
materials that may expose us to expensive and time-consuming legal claims.
Our research and development programs involve the use of hazardous
materials, chemicals and radioactive and biological materials. We are subject
to foreign, federal, state and local environmental and health and safety laws
and regulations governing, among other matters, the use, manufacture, handling,
storage, and disposal of hazardous materials and waste products. We may incur
significant costs to comply with these current or future environmental and
health and safety laws and regulations. In addition, we cannot completely
eliminate the risk of contamination or injury from hazardous materials and may
incur material liability as a result of such contamination or injury. In the
event of an accident, an injured party may seek to hold us liable for any
damages that result. Any liability could exceed the limits or fall outside the
coverage of our workers compensation, property and business interruption
insurance and we may not be able to maintain insurance on acceptable terms, if
at all. We currently carry no insurance specifically covering environmental
claims.
23
Risks related to an investment in our
Common Stock
Our common stock
may have a volatile public trading price and a low trading volume.
The market prices for securities of companies comparable to us have
been highly volatile. Often, these stocks have experienced significant price
and volume fluctuations for reasons unrelated to the operating performance of
the individual companies. The market price of our stock may be similarly
volatile. Factors giving rise to this
volatility may include:
disclosure of actual or potential results with respect to product
candidates we are developing;
regulatory developments in both the United States and abroad;
developments concerning proprietary rights, including patents and
litigation matters;
public concern about the safety or efficacy of our product candidates
or technology, or related technology, or new technologies generally;
public announcements by our competitors or others; and
general market conditions and comments by securities analysts and
investors.
Fluctuations in our
operating losses could adversely affect the price of our common stock.
Our operating losses may fluctuate significantly on a quarterly basis.
Some of the factors that may cause our operating losses to fluctuate on a
period-to-period basis include the status of our preclinical and clinical
development programs, level of expenses incurred in connection with our
preclinical and clinical development programs, implementation or termination of
collaboration, licensing, manufacturing or other material agreements with third
parties, non-recurring revenue or expenses under any such agreement, and
compliance with regulatory requirements. Period-to-period comparisons of our
historical and future financial results may not be meaningful, and investors
should not rely on them as an indication of future performance. Our fluctuating
losses may fail to meet the expectations of securities analysts or investors.
Our failure to meet these expectations may cause the price of our common stock
to decline.
Because of expected
volatility in our trading price and trading volume, we may incur significant
costs from class action litigation.
Our stock price may fluctuate for many reasons, including as a result
of public announcements regarding the progress of our development efforts, the
addition or departure of our key personnel, variations in our quarterly
operating results and changes in market valuations of pharmaceutical,
biotechnology or other life science companies. Recently, when the market price
of a stock has been volatile, as our stock price may be, holders of that stock
have occasionally brought securities class action litigation against the
company that issued the stock. If any of our stockholders were to bring a
lawsuit of this type against us, even if the lawsuit is without merit, we could
incur substantial costs defending the lawsuit. A stockholder lawsuit could also
divert the time and attention of our management, which could adversely affect
our business.
Future sales of our
common stock may cause the market price of our common stock to decline.
The market price of our common stock may decline if our stockholders or
we sell shares of our common stock. A small
number of stockholders own a significant number of shares that they will be
able to sell in the public market in the near future. Sales by our current stockholders of a
substantial number of shares, or the expectation that such sales may occur,
could significantly reduce the market price of our common stock. Moreover, the holders of a substantial number
of shares of common stock have rights, subject to certain conditions, to
require us to file registration statements to permit the resale of their shares
in the public market or to include their shares in registration statements that
we may file for ourselves or other stockholders.
We have filed a registration statement ninety days following our
initial public offering to permit the sale of shares of our common stock that
we may issue under our stock option plan.
As a result, these shares may be freely sold in the public market upon
issuance, subject to restrictions under the securities laws and lock-up
agreements. In connection with our
initial public offering, most of our stockholders have agreed, subject to
certain limited exceptions, not to sell any shares of our common stock owned by
them, for a period of 180 days after the closing of this offering unless
they first obtain the written consent of J.P. Morgan Securities Inc.
Our management team
may invest or spend the proceeds from our initial public offering in ways with
which our stockholders may not agree or in ways which may not yield a
significant return.
We may allocate the proceeds from our initial public offering in ways
that stockholders may not support. Our management has considerable discretion
in the application of the net proceeds of our initial public offering. We may use the net proceeds for corporate
purposes that do not increase our profitability or our stock price. Until the
net proceeds are used, we intend to invest them in accordance with our
investment policy, which includes investments in short-term, interest-bearing,
investment-grade securities or guaranteed obligations of the United States or
other governments or their agencies.
24
We will incur
significant increased costs as a result of operating as a public company, and
our management will be required to devote substantial time to new compliance
initiatives.
As a public company, we are incurring and will continue to incur
significant legal, accounting and other expenses that we did not incur as a
private company. In addition, the
Sarbanes-Oxley Act, as well as rules adopted or proposed by the United States
Securities and Exchange Commission, or SEC, and by The NASDAQ Global Market,
have imposed various requirements on public companies, including establishment
and maintenance of effective disclosure and financial controls and changes in
corporate governance practices. Our
management and other personnel will need to devote a substantial amount of time
to these new compliance initiatives.
Moreover, these rules and regulations have already and will continue to
increase our legal and financial compliance costs and will make some activities
more time-consuming and costly. For
example, we expect these laws and regulations will make it more difficult and
more costly for us to obtain certain types of insurance, including director and
officer liability insurance, and we may be forced to accept reduced policy
limits and coverage or incur substantially higher costs to obtain the same or
similar coverage. The impact of these events could also make it more difficult
for us to attract and retain qualified persons to serve on our board of
directors, our board committees or as executive officers. We cannot estimate
the amount or timing of additional costs we may incur as a result of these laws
and regulations.
Section 404 of
the Sarbanes-Oxley Act of 2002 will require us to document and test our
internal control over financial reporting for fiscal year 2008 and beyond and
will require an independent registered public accounting firm to report on our
assessment as to the effectiveness of these controls. Any delays or difficulty
in satisfying these requirements could adversely affect our future results of
operations and our stock price.
Section 404 of the Sarbanes-Oxley Act of 2002 will require us to
document and test the effectiveness of our internal control over financial
reporting in accordance with an established internal control framework and to
report on our conclusion as to the effectiveness of our internal controls. It
will also require an independent registered public accounting firm to test our
internal control over financial reporting and report on the effectiveness of
such controls for our fiscal year ending December 31, 2008 and subsequent
years. An independent registered public accounting firm will also be required
to test, evaluate and report on the completeness of our assessment. In
addition, we are required under the Securities Exchange Act of 1934 to maintain
disclosure controls and procedures and internal control over financial
reporting. Moreover, it may cost us more than we expect to comply with these
control- and procedure-related requirements.
We may in the future discover areas of our internal controls that need
improvement. We cannot be certain that any remedial measures we take will
ensure that we implement and maintain adequate internal controls over our
financial processes and reporting in the future. Any failure to implement
required new or improved controls, or difficulties encountered in their
implementation, could harm our operating results or cause us to fail to meet
our reporting obligations. If we are unable to conclude that we have effective
internal control over financial reporting, or if our independent registered
public accounting firm is unable to provide us with an unqualified opinion
regarding the effectiveness of our internal control over financial reporting as
of December 31, 2008 and in future periods as required by
Section 404, investors could lose confidence in the reliability of our
consolidated financial statements, which could result in a decrease in the
value of our common stock. Failure to comply with Section 404 could
potentially subject us to sanctions or investigations by the SEC, the NASD or
other regulatory authorities.
Anti-takeover
provisions in our charter documents and provisions of Delaware law may make an
acquisition more difficult.
We are incorporated in Delaware. Anti-takeover provisions of Delaware
law and our charter documents may make a change in control more difficult.
Also, under Delaware law, our board of directors may adopt additional
anti-takeover measures.
Our charter authorizes our board of directors to issue up to 20,000,000
shares of preferred stock and to determine the terms of those shares of stock
without any further action by our stockholders. If the board of directors exercises
this power to issue preferred stock, it could be more difficult for a third
party to acquire a majority of our outstanding voting stock.
Our charter also provides staggered terms for the members of our board
of directors. Under Section 141 of the Delaware General Corporation Law, our
directors may be removed by stockholders only for cause and only by a vote of
the holders of a majority of voting shares then outstanding. These provisions may prevent stockholders
from replacing the entire board in a single proxy contest, making it more
difficult for a third party to acquire control of us without the consent of our
board of directors. These provisions
could also delay the removal of management by the board of directors with our
without cause. In addition, our bylaws
limit the ability of our stockholders to
call special meetings of stockholders.
Our stock option plan generally permits our board of directors to
provide for acceleration of vesting of options granted under the plan in the
event of certain transactions that result in a change of control. If our board
of directors uses its authority to accelerate vesting of options, this action
could make an acquisition more costly, and it could prevent an acquisition from
going forward.
Under Section 203 of the Delaware General Corporation Law, a
corporation may not engage in a business combination with any holder of 15% or
more of its capital stock until the holder has held the stock for three years
unless, among other possibilities, the board
25
of directors approves the transaction. Our board of directors could use
this provision to prevent changes in management. The existence of the foregoing
provisions could limit the price that investors might be willing to pay in the
future for shares of our common stock.
Our officers and
directors and other affiliates may be able to exert significant control over
the company.
Currently, our executive officers, directors, and other affiliates
control approximately 24% of our outstanding common stock. Therefore, our
executive officers, directors and other affiliates have the ability to
influence the company through this ownership position.
These stockholders, if they act together, may be able to influence all
matters requiring stockholder approval, including the election of directors,
amendments of our organizational documents, or approval of any merger, sale of
assets, or other major corporation transaction. This may prevent or discourage
unsolicited acquisition proposals or offers for our common stock that you may
feel are in your best interest as one of our stockholders.
26
Item 2. Unregistered Sales of Equity Securities and Use
of Proceeds
Unregistered Sales of Equity Securities
During
the period from July 1, 2007 until September 30, 2007, we issued 4,046 shares
of common stock upon option exercises for an aggregate sale price of
approximately $2,000.
Use of Proceeds from Registered Securities
Our initial public
offering of common stock was effected through a Registration Statement on
Form S-1 (File No. 333-140979), that was declared effective by the
Securities and Exchange Commission on May 22, 2007, which registered an
aggregate of 5,750,000 shares of our common stock. On May 22, 2007, an additional 1,150,000
shares of our common stock were registered through a Registration Statement
filed pursuant to Rule 462(b) (File No. 333-143174). On May 29, 2007, we completed an initial
public offering of 6,000,000 shares of our common stock at a price to the
public of $10.00 per share. J.P. Morgan
Securities Inc, CIBC World Markets Corp., Piper Jaffray & Co., JMP
Securities LLC and Rodman & Renshaw, LLC were the managing underwriters of
the initial public offering. In
addition, on May 29, 2007 in connection with the exercise of the underwriters
over-allotment option, 900,000 additional shares of common stock were sold on
our behalf at the initial public offering price of $10.00 per share, for
aggregate gross proceeds of $9.0 million.
There were no selling stockholders in the offering.
We paid $4.8 million in
underwriting discounts to the underwriters in connection with the
offering. In addition, we incurred
additional costs of approximately $1.7 million in connection with the offering,
which then added to the underwriting discounts paid by us, amounts to total
expenses of approximately $6.5 million.
Thus the net offering proceeds to us, after deducting underwriting
discounts and offering expenses, were approximately $62.5 million. No offering expenses were paid directly or
indirectly to any of our directors or officers (or their associates) or persons
owning ten percent or more of any class of our equity securities or to any
other affiliates.
We have used approximately
$11.4 million of the net proceeds from the initial public offering to fund the
clinical development of SRT501, to advance and expand our preclinical
development of additional product candidates targeting SIRT1, other sirtuins
and related pathways, and for working capital, capital expenditures and other
general corporate purposes. We have invested the unused proceeds from the
offering in short-term interest-bearing, investment grade securities.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Submission of Matters To a Vote of Security Holders.
None.
Item 5. Other Information.
The description of the
lease amendment for 200 Technology Square, Cambridge, Massachusetts, is
described in Form 8-K filed November 9, 2007 with the Securities and Exchange
Commission and above in Part 1, Item 2 under Contractual Obligations.
Item 6. Exhibits.
(a)
Exhibits.
The Exhibits listed in
the Exhibit Index immediately preceding the Exhibits are filed as a part
of this Quarterly Report on Form 10-Q.
27