UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM 10-Q
x
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
|
For
the quarterly period ended March 31, 2008.
or
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
|
For
the transition period
from to .
Commission
File Number 000-51171
SIRTRIS
PHARMACEUTICALS, INC.
(Exact name of
registrant as specified in its charter)
Delaware
|
|
20-1410189
|
(State or other
jurisdiction of
|
|
(IRS Employer
Identification Number)
|
incorporation or
organization)
|
|
|
|
|
|
200
Technology Square
|
|
|
Cambridge,
Massachusetts
|
|
02139
|
(Address of
Principal Executive Offices)
|
|
(Zip Code)
|
(617)
252-6920
(Registrants
telephone number, including area code)
None
(Former name,
former address and former fiscal year, if changes since last report)
Indicate by check mark
whether the registrant (1) has filed all reports required to be filed by Section 13
or 15(d) of the Securities Exchange Act of 1934 during the preceding 12
months (or for such shorter period that the registrant was required to file
such reports), and (2) has been subject to such filing requirements for
the past 90 days. Yes
x
No
o
Indicate by check mark
whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See definitions of
large accelerated filer, accelerated filer, and smaller reporting company
in Rule 12b-2 of the Exchange Act. (Check one):
Large
accelerated filer
o
|
|
Accelerated
filer
o
|
|
|
|
Non-accelerated
filer
x
|
|
Smaller
reporting company
o
|
(Do not check if
a smaller reporting company)
|
|
|
Indicate by check mark
whether the registrant is a shell company (as defined in Rule 12b-2 of the
Act).Yes
o
No
x
Number of shares of the
registrants common stock, $0.001 par value per share, outstanding as of May 9,
2008: 29,275,644 shares
SIRTRIS
PHARMACEUTICALS, INC.
QUARTERLY
REPORT
ON
FORM 10-Q
INDEX
2
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 statements about the proposed merger with
SmithKline Beecham Corporation, 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.
3
Sirtris
Pharmaceuticals, Inc.
(A
development-stage company)
Consolidated
Balance Sheets
(in thousands,
except per share amounts)
(Unaudited)
|
|
March 31,
|
|
December 31,
|
|
|
|
2008
|
|
2007
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
27,656
|
|
$
|
23,062
|
|
Short-term
investments
|
|
79,879
|
|
95,024
|
|
Prepaid expenses
and other current assets
|
|
1,568
|
|
1,610
|
|
Restricted cash
|
|
|
|
26
|
|
Total current
assets
|
|
109,103
|
|
119,722
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
3,579
|
|
3,221
|
|
Other assets
|
|
159
|
|
172
|
|
Restricted cash
|
|
2,100
|
|
2,100
|
|
Total assets
|
|
$
|
114,941
|
|
$
|
125,215
|
|
|
|
|
|
|
|
Liabilities
and stockholders equity
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
Accounts payable
|
|
$
|
2,010
|
|
$
|
2,558
|
|
Accrued expenses
|
|
1,534
|
|
2,932
|
|
Current portion
of notes payable
|
|
2,565
|
|
2,498
|
|
Total current
liabilities
|
|
6,109
|
|
7,988
|
|
|
|
|
|
|
|
Notes payable,
net of current portion and discount
|
|
6,042
|
|
6,711
|
|
|
|
|
|
|
|
Stockholders
equity:
|
|
|
|
|
|
Preferred stock,
$0.001 par value; 20,000 shares authorized; none issued
|
|
|
|
|
|
Common stock,
$0.001 par value: 100,000 shares authorized; 29,263 and 28,758 shares issued
and outstanding at March 31, 2008 and December 31, 2007,
respectively
|
|
29
|
|
29
|
|
Additional
paid-in capital
|
|
171,166
|
|
169,932
|
|
Accumulated
other comprehensive income
|
|
324
|
|
218
|
|
Deficit
accumulated during the development stage
|
|
(68,729
|
)
|
(59,663
|
)
|
Total
stockholders equity
|
|
102,790
|
|
110,516
|
|
Total
liabilities and stockholders equity
|
|
$
|
114,941
|
|
$
|
125,215
|
|
4
Sirtris
Pharmaceuticals, Inc.
(A
development-stage company)
Consolidated
Statements of Operations
(in thousands,
except share and per share amounts)
(Unaudited)
|
|
Three months ended March 31,
|
|
Period from March
25, 2004 (date of
inception) through
|
|
|
|
2008
|
|
2007
|
|
March 31
, 2008
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
|
500
|
|
$
|
|
|
$
|
568
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development (1)
|
|
7,882
|
|
5,120
|
|
59,411
|
|
General and
administrative (1)
|
|
2,637
|
|
1,239
|
|
17,698
|
|
Total operating
expenses
|
|
10,519
|
|
6,359
|
|
77,109
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
(10,019
|
)
|
(6,359
|
)
|
(76,541
|
)
|
Interest income
|
|
1,258
|
|
900
|
|
10,388
|
|
Interest expense
|
|
(305
|
)
|
(324
|
)
|
(2,576
|
)
|
Net loss
|
|
$
|
(9,066
|
)
|
$
|
(5,783
|
)
|
$
|
(68,729
|
)
|
|
|
|
|
|
|
|
|
Net loss per
share - basic and diluted
|
|
$
|
(0.32
|
)
|
$
|
(4.71
|
)
|
|
|
Weighted average
number of common shares used in net loss per basic and diluted share
|
|
28,756,828
|
|
1,233,707
|
|
|
|
(1) Amounts include stock-based compensation expense, as follows:
Research
and development
|
|
$
|
540
|
|
$
|
181
|
|
|
|
General
and administrative
|
|
$
|
506
|
|
$
|
93
|
|
|
|
5
Sirtris
Pharmaceuticals, Inc.
(A
development-stage company)
Consolidated
Statements of Cash Flow
(in thousands)
(Unaudited)
|
|
Three months ended March 31,
|
|
Period from March
25, 2004 (date of
inception) through
|
|
|
|
2008
|
|
2007
|
|
March 31, 2008
|
|
|
|
|
|
|
|
|
|
Operating activities
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(9,066
|
)
|
$
|
(5,783
|
)
|
$
|
(68,729
|
)
|
Adjustments to
reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
Depreciation and
amortization
|
|
225
|
|
106
|
|
1,278
|
|
Stock-based
compensation expense
|
|
1,046
|
|
274
|
|
4,874
|
|
Issuance of
common stock in exchange for licenses and services
|
|
|
|
|
|
82
|
|
Non-cash rent
expense
|
|
|
|
28
|
|
97
|
|
Non-cash
interest expense
|
|
39
|
|
36
|
|
347
|
|
Change in
operating assets and liabilities:
|
|
|
|
|
|
|
|
Prepaid expenses
and other current assets
|
|
42
|
|
(58
|
)
|
(1,568
|
)
|
Other assets
|
|
13
|
|
(681
|
)
|
(193
|
)
|
Accounts payable
|
|
(548
|
)
|
1,525
|
|
2,010
|
|
Accrued expenses
|
|
(1,398
|
)
|
(571
|
)
|
1,534
|
|
Net cash used in
operating activities
|
|
(9,647
|
)
|
(5,124
|
)
|
(60,268
|
)
|
|
|
|
|
|
|
|
|
Investing
activities
|
|
|
|
|
|
|
|
Purchases of
property and equipment
|
|
(583
|
)
|
(674
|
)
|
(4,857
|
)
|
Purchases of
short-term investments
|
|
(49,980
|
)
|
(36,972
|
)
|
(344,400
|
)
|
Sales and
maturities of short-term investments
|
|
65,231
|
|
23,517
|
|
264,845
|
|
Decrease
(increase) in restricted cash
|
|
26
|
|
|
|
(2,100
|
)
|
Net cash
provided by (used in) investing activities
|
|
14,694
|
|
(14,129
|
)
|
(86,512
|
)
|
|
|
|
|
|
|
|
|
Financing
activities
|
|
|
|
|
|
|
|
Proceeds from
issuance of redeemable convertible preferred stock
|
|
|
|
35,890
|
|
102,565
|
|
Proceeds from
issuance of common stock
|
|
188
|
|
62
|
|
62,835
|
|
Proceeds from
note payable
|
|
|
|
|
|
10,797
|
|
Repayment of
note payable
|
|
(641
|
)
|
|
|
(1,761
|
)
|
Net cash (used
in) provided by financing activities
|
|
(453
|
)
|
35,952
|
|
174,436
|
|
|
|
|
|
|
|
|
|
Net increase in
cash and cash equivalents
|
|
4,594
|
|
16,699
|
|
27,656
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents at beginning of the period
|
|
23,062
|
|
7,513
|
|
|
|
Cash
and cash equivalents at end of the period
|
|
$
|
27,656
|
|
$
|
24,212
|
|
$
|
27,656
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of non-cash financing activities:
|
|
|
|
|
|
|
|
Accretion of
redeemable convertible preferred stock to redemption value
|
|
$
|
|
|
$
|
22
|
|
$
|
173
|
|
Discount to note
payable for warrant valuation
|
|
$
|
|
|
$
|
185
|
|
$
|
604
|
|
6
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 months ended March 31, 2008
are not necessarily indicative of the results that may be expected for any
other interim period or for the fiscal year ending December 31, 2008.
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, 2007 included in the Companys Annual Report on Form 10-K
as filed with the Securities and Exchange Commission (SEC) on March 24,
2008.
2. Fair
Value Measurements
On January 1, 2008,
the Company adopted
Statement
of Financial Accounting Standards (SFAS) No. 157,Fair Value
Measurements, ( SFAS 157), which defines fair value, establishes a
framework for measuring fair value under GAAP, and expands disclosures about
fair value measurements. SFAS 157 defines fair value, establishes a three
level valuation hierarchy for disclosure of fair value measurement and enhances
disclosure requirements for fair value measurements. The valuation hierarchy is
based upon the transparency of inputs to the valuation of an asset or liability
as of the measurement date. The three levels are defined as follows:
·
Level 1 inputs to the valuation
methodology are quoted prices (unadjusted) for identical assets or liabilities
in active markets.
·
Level 2 inputs to the valuation
methodology include quoted prices for similar assets and liabilities in active
or non- active markets, inputs other than quoted prices that are
observable for the asset or liability, and inputs that are not directly
observable, but are corroborated by observable market data.
·
Level 3 inputs to the valuation
methodology are unobservable for the asset or liability.
A level 1 classification
is applied to any asset that has a readily available quoted price from an
active market where there is significant transparency in the executed / quoted
price. A level 2 classification is applied to assets that have evaluated prices
received from fixed income vendors where the data inputs to these valuations do
not represent quoted prices from an active market. In certain cases where there
is limited activity or less transparency around input to the valuation, securities
are classified within level 3 of the valuation hierarchy.
Assets measured at fair
value at March 31, 2008 are as follows:
|
|
Fair Value Measurement as of March 31, 2008
|
|
|
|
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
|
Available-for-sale
securities
|
|
$
|
14,446
|
|
$
|
65,433
|
|
$
|
|
|
$
|
79,879
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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).
7
Sirtris
Pharmaceuticals, Inc.
(A
development-stage company)
Notes
to Consolidated Financial Statements
(
in thousands, except share and per share amounts
)
(Unaudited)
Short-term investments
included the following at March 31, 2008 and December 31, 2007:
March 31, 2008
|
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair
Value
|
|
Commercial paper
|
|
$
|
41,089
|
|
$
|
282
|
|
$
|
|
|
$
|
41,371
|
|
Asset-backed
securities
|
|
10,661
|
|
31
|
|
|
|
10,692
|
|
Corporate debt
securities
|
|
27,805
|
|
16
|
|
(5
|
)
|
27,816
|
|
|
|
$
|
79,555
|
|
$
|
329
|
|
$
|
(5
|
)
|
$
|
79,879
|
|
December 31, 2007
|
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair
Value
|
|
Commercial paper
|
|
$
|
47,555
|
|
$
|
199
|
|
$
|
|
|
$
|
47,754
|
|
Asset-backed
securities
|
|
20,371
|
|
27
|
|
|
|
20,398
|
|
Corporate debt
securities
|
|
26,880
|
|
7
|
|
(15
|
)
|
26,872
|
|
|
|
$
|
94,806
|
|
$
|
233
|
|
$
|
(15
|
)
|
$
|
95,024
|
|
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 March 31, 2008, the Company held four 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 March 31,
2008 and December 31, 2007 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 March 31,
|
|
|
|
|
|
|
|
2008
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
applicable to common stockholders:
|
|
$
|
(9,066
|
)
|
$
|
(5,805
|
)
|
|
|
|
|
Unrealized gain
on investments
|
|
106
|
|
2
|
|
|
|
|
|
Comprehensive
loss
|
|
$
|
(8,960
|
)
|
$
|
(5,803
|
)
|
|
|
|
|
6. Accounting for Stock-Based Compensation
The Company follows the
provisions of SFAS 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 months ended March 31, 2008, the Company recorded stock-based
compensation expense of approximately $788 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 123R 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
Amended & Restated Incentive Plan (Plan) provides for the issuance
of a total of 5,053,702 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. All outstanding 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. Pursuant to the Plans evergreen provision, 1,006,545 shares were
added to the Plan on January 1, 2008.
As of March 31,
2008, there were 354,182 shares available for future issuance under the plan.
A summary of the status
of the Plan at March 31, 2008 and changes during the three months then
ended is presented in the table and narrative below:
8
Sirtris
Pharmaceuticals, Inc.
(A
development-stage company)
Notes
to Consolidated Financial Statements
(
in thousands, except share and per share amounts
)
(Unaudited)
|
|
Options
|
|
Weighted-
Average
Exercise Price
|
|
Weighted
Average
Remaining
Contractual
Term
|
|
Aggregate
Intrinsic Value
|
|
Options
outstanding at December 31, 2007
|
|
2,818,887
|
|
$
|
2.19
|
|
8.26
|
|
$
|
32,441
|
|
Options granted
|
|
754,357
|
|
$
|
12.95
|
|
|
|
|
|
Options
exercised
|
|
(164,440
|
)
|
$
|
1.14
|
|
|
|
|
|
Options
forfeited or expired
|
|
(37,285
|
)
|
$
|
5.00
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options
outstanding at March 31, 2008
|
|
3,371,519
|
|
$
|
4.62
|
|
8.31
|
|
$
|
28,300
|
|
Vested or
expected to vest at March 31, 2008
|
|
3,046,438
|
|
$
|
4.54
|
|
8.30
|
|
$
|
25,803
|
|
Options
exercisable at March 31, 2008
|
|
1,019,305
|
|
$
|
1.25
|
|
7.79
|
|
$
|
11,962
|
|
The aggregate intrinsic
value in the table above represents the value (the difference between the
Companys closing common stock price on March 31, 2008 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 March 31, 2008. As of March 31, 2008, there was
$10.2 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 2.63 years. The weighted-average grant date
fair value of options granted during the three months ended March 31, 2008
was $6.95. The intrinsic value of stock options exercised for the three months
ended March 31, 2008 was $1.9 million, 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 months ended March 31,
2008. The Company averaged the volatilities and expected terms of 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 March 31,
|
|
|
|
2008
|
|
2007
|
|
|
|
|
|
|
|
Expected term
(life in years)
|
|
5.53
|
|
5.69
|
|
Interest rate
|
|
3.21
|
%
|
4.75
|
%
|
Volatility
|
|
54.0
|
%
|
72.3
|
%
|
Dividend yield
|
|
|
|
|
|
Restricted
Stock
A summary of the status
of nonvested restricted stock as of March 31, 2008 and changes during the
three months ended March 31, 2008 are as follows:
|
|
Shares
|
|
Nonvested at
December 31, 2007
|
|
76,190
|
|
Granted
|
|
339,737
|
|
Vested
|
|
(19,048
|
)
|
Canceled
|
|
|
|
Nonvested at
March 31, 2008
|
|
396,879
|
|
Stock
Options Granted to Non-Employees
The Company granted stock
options to purchase 20,000 shares of common stock to non-employees at an
exercise price of $13.00 in the three months ended March 31, 2008. The
stock options vest over 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 3.74%, (ii) contractual life
of ten years, (iii) volatility of 74.9% and (iv) no expected
dividends. The Company recognized stock-based compensation expense relating to
the estimated fair value of non-employee options of $258 for the three months
ended March 31, 2008. The unvested stock options are
9
Sirtris
Pharmaceuticals, Inc.
(A
development-stage company)
Notes
to Consolidated Financial Statements
(
in thousands, except share and per share amounts
)
(Unaudited)
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
March 31,
|
|
|
|
2008
|
|
2007
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(9,066
|
)
|
$
|
(5,783
|
)
|
Accretion of
redeemable convertible preferred stock issuance costs
|
|
|
|
(22
|
)
|
Net loss
applicable to common stockholders
|
|
$
|
(9,066
|
)
|
$
|
(5,805
|
)
|
Weighted-average
number of common shares used in net loss per share-basic and diluted
|
|
28,756,828
|
|
1,233,707
|
|
Net loss per
share applicable to common stockholdersbasic and diluted
|
|
$
|
(0.32
|
)
|
$
|
(4.71
|
)
|
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 March 31, 2008 and 2007, as they would be anti-dilutive.
|
|
Three Months Ended
March 31,
|
|
|
|
2008
|
|
2007
|
|
|
|
|
|
|
|
Redeemable
convertible preferred stock
|
|
|
|
20,287,131
|
|
Options
outstanding
|
|
3,371,519
|
|
2,767,174
|
|
Unvested
restricted stock under the 2004 Stock Option Plan
|
|
396,879
|
|
133,333
|
|
Unvested
restricted stock issued to founders
|
|
20,857
|
|
81,539
|
|
Warrants
outstanding
|
|
96,939
|
|
99,465
|
|
8. Subsequent Event
On April 22, 2008,
the Company entered into an Agreement and Plan of Merger (the Merger Agreement)
with SmithKline Beecham Corporation, a Pennsylvania corporation (SKB), and
Fountain Acquisition Corporation, a Delaware corporation and a wholly-owned
subsidiary of SKB (the Purchaser), pursuant to which, among other things, the
Purchaser agreed to commence a tender offer for all the outstanding shares of
common stock of the Company, subject to the terms and conditions of the Merger
Agreement. SKB is a wholly-owned subsidiary of GlaxoSmithKline plc (GSK).
Pursuant to the Merger Agreement, and upon the terms and subject to the
conditions thereof, the Purchaser commenced a tender offer on May 2, 2008
(the Offer) to acquire all the outstanding shares of Company common stock, par
value $0.001 per share (Company Common Stock), at a price of $22.50 per
share, net to the selling stockholders in cash, without interest thereon (the Offer
Price). Pursuant to the Merger Agreement, after the consummation of the Offer,
and subject to the satisfaction or waiver of certain conditions set forth in
the Merger Agreement, the Purchaser will merge with and into the Company (the Merger)
and the Company will become a wholly-owned subsidiary of SKB. At the effective
time of the Merger, each issued and outstanding share of Company Common Stock
(the Shares) (other than Shares owned by the Company, GSK or any wholly-owned
subsidiary of GSK, and Shares held by stockholders who have perfected their
statutory rights of appraisal under Section 262 of the Delaware General
Corporation Law) will be automatically converted into the right to receive the
Offer Price in cash, without interest, as set forth above. The Merger Agreement
includes certain representations, warranties and covenants of the Company, SKB
and the Purchaser. Among others, the Company has agreed to operate its business
in the ordinary course until the Offer is consummated. The Company has also
agreed not to solicit or initiate discussions with third parties regarding
other proposals to acquire the Company and to certain restrictions on its
ability to respond to such proposals. The Merger Agreement also includes
customary termination provisions for both the Company and SKB and provides
that, in connection with the termination of the Merger Agreement under
specified circumstances, the Company will be required to pay to SKB a
termination fee of $22.5 million. In connection with the proposed Merger,
the Company agreed to pay its financial advisor a transaction fee for its
services of approximately $7.2 million, in addition to a discretionary fee
of up to $1.4 million to be determined by the Companys board of directors
prior to closing, payable upon the consummation of the Offer and the Merger.
10
Sirtris
Pharmaceuticals, Inc.
(A
development-stage company)
Notes
to Consolidated Financial Statements
(
in thousands, except share and per share amounts
)
(Unaudited)
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,
2007 and the related Managements Discussion and Analysis of Financial
Condition and Results of Operations, both of which are contained in the Companys
Annual Report on
Form 10-K as filed with the SEC on March 24, 2008. 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 March 31, 2008, we have an
accumulated deficit of $68.7 million. We had net losses of $9.7 million
for the year ended December 31, 2005, $17.0 million for the year
ended December 31, 2006, $31.1 million for the year ended December 31,
2007 and $9.1 million for the three months ended March 31, 2008. 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.
On April 22,
2008, we entered into an Agreement and Plan of Merger (the Merger Agreement)
with SmithKline Beecham Corporation, a Pennsylvania corporation (SKB), and
Fountain Acquisition Corporation, a Delaware corporation and a wholly-owned
subsidiary of SKB (the Purchaser), pursuant to which, among other things, the
Purchaser agreed to commence a tender offer for all our outstanding shares of
common stock, subject to the terms and conditions of the Merger Agreement. SKB
is a wholly-owned subsidiary of GlaxoSmithKline plc (GSK). Pursuant to the
Merger Agreement, and upon the terms and subject to the conditions thereof, the
Purchaser commenced a tender offer on May 2, 2008 (the Offer) to acquire
all of our outstanding shares of common stock, par value $0.001 per share (Company
Common Stock), at a price of $22.50 per share, net to the selling stockholders
in cash, without interest thereon (the Offer Price). Pursuant to the Merger
Agreement, after the consummation of the Offer, and subject to the satisfaction
or waiver of certain conditions set forth in the Merger Agreement, the
Purchaser will merge with and into us (the Merger) and we will become a
wholly-owned subsidiary of SKB. At the effective time of the Merger, each
issued and outstanding share of Company Common Stock (the Shares) (other than
Shares owned by us, GSK or any wholly-owned subsidiary of GSK, and Shares held
by stockholders who have perfected their statutory rights of appraisal under Section 262
of the Delaware General Corporation Law) will be automatically converted into
the right to receive the Offer Price in cash, without interest, as set forth
above. The Merger Agreement includes certain representations, warranties and
covenants of us, SKB and the Purchaser. Among others, we have agreed to operate
its business in the ordinary course until the Offer is consummated. We have
also agreed not to solicit or initiate discussions with third parties regarding
other proposals to acquire us and to certain restrictions on our ability to
respond to such proposals. The Merger Agreement also includes customary
termination provisions for both us and SKB and provides that, in connection
with the termination of the Merger Agreement under specified circumstances, we
will be required to pay to SKB a termination fee of $22.5 million. In
connection with the proposed Merger, we agreed to pay our financial advisor a
transaction fee for its services of approximately $7.2 million, in
addition to a discretionary fee of up to $1.4 million to be determined by our
board of directors prior to closing, payable upon the consummation of the Offer
and the Merger.
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 included in the Companys
Annual Report on Form 10-K as filed with the SEC on March 24, 2008.
There were no changes to such critical accounting policies in the three months
ended March 31, 2008.
11
Sirtris
Pharmaceuticals, Inc.
(A
development-stage company)
Notes
to Consolidated Financial Statements
(
in thousands, except share and per share amounts
)
(Unaudited)
Results of Operations
Comparison of the Three Months ended March 31,
2008 (the 2008 Quarter) and March 31, 2007 (the 2007 Quarter)
Revenue
. Revenue for the 2008 Quarter of $500,000 represents a payment from a
sublicense for worldwide rights to certain technology in the field of plants.
For the 2007 Quarter, we recorded no revenue.
Research and development.
Research
and development expense for the 2008 Quarter was $7.9 million compared to
$5.1 million for the 2007 Quarter. The $2.8 million increase from the 2007
Quarter to the 2008 Quarter principally resulted from an increase of $697,000
in occupancy costs primarily due to costs relating to a new facility, an
increase of $477,000 for personnel costs related principally to an increase in
research and development headcount, an increase of $450,000 in preclinical
studies, an increase of $359,000 in stock-based compensation expense, an
increase of $275,000 in formulation costs for our product candidates, an
increase of $230,000 in consulting expense and an increase in general lab supplies
of $143,000.
General and administrative
. General
and administrative expense for the 2008 Quarter was $2.6 million compared
to $1.2 million for the 2007 Quarter. The $1.4 million increase from the
2007 Quarter to the 2008 Quarter was primarily due to an increase of $413,000
in professional fees primarily as a result of being a public company, an
increase of $413,000 in stock-based compensation expense and an increase of
$256,000 in personnel costs.
Interest income
.
Interest
income increased to $1.3 million for the 2008 Quarter from $900,000 for the
2007 Quarter. The increase in interest income was caused by an increase in the
average fund balances available for investment. The increase in the average
fund balances for investment was primarily due to net proceeds of approximately
$35.9 million from the sale of redeemable convertible preferred stock in January and
February of 2007 and net proceeds of approximately $62.5 million from the
completion of our initial public offering in May 2007.
Interest expense.
Interest
expense decreased to $305,000 for the 2008 Quarter from $324,000 for the 2007
Quarter. The decrease in interest expense from the 2007 Quarter to the 2008
Quarter was primarily due to lower outstanding balances under a loan agreement
with Hercules Technology Growth Capital, Inc. and an equipment loan agreement
with Silicon Valley Bank.
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 March 31, 2008, we had cash, cash equivalents and short-term
investments of approximately $107.5 million. Our funds are currently
invested in investment grade and United States government securities.
During
the 2008 Quarter and 2007 Quarter, our operating activities used cash of
$9.6 million and $5.1 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 2008 Quarter
was due primarily to an increase in research and development activities as
noted above.
Our
investing activities provided cash of $14.7 million during the 2008 Quarter and
used cash of $14.1 million during 2007 Quarter. Investing activities provided
cash during the 2008 Quarter because cash provided from sales and maturities of
short-term investment exceeded cash used to purchase short-term investments. Investing
activities used cash during the 2007 Quarter because cash used to purchase
short-term investments exceeded cash provided from sales and maturities of
short-term investments.
Our
financing activities used cash of $453,000 in the 2008 Quarter and provided
cash of $36.0 million in the 2007 Quarter. Cash used in the 2008 Quarter
resulted from the repayment of notes payable, partially offset by proceeds from
the issuance of common stock from the exercise of stock options. Cash provided
in the 2007 Quarter 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 approximately $35.9 million.
In April 2006,
we obtained a loan from Hercules Technology Growth Capital, Inc. 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, so there is no
remaining amount available under this loan. We were 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 March 31, 2008, there was $8.5 million outstanding 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
12
Sirtris
Pharmaceuticals, Inc.
(A
development-stage company)
Notes
to Consolidated Financial Statements
(
in thousands, except share and per share amounts
)
(Unaudited)
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 will 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 Silicon Valley Bank to borrow
up to $1.5 million through March 2007. Amounts borrowed under the
equipment loan agreement are repayable over 36 months beginning in April 2007
and bear interest at prime plus 0.25% per annum. As of March 31, 2008,
there was $532,000 outstanding and no remaining amount available under the
equipment loan agreement. 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
warrant for the remaining 2,223 additional shares of our common stock was
cancelled since we did not make any additional borrowings under this loan
before March 2007. The warrant was exercised in December 2007
to purchase 2,526 shares of our common stock. The equipment loan agreement was
repaid in April 2008.
We expect our existing
resources to be sufficient to fund our planned operations until at least early
2010.
Contractual Obligations
There
are no other additional material obligations incurred by us that materially
change the disclosure of our contractual obligations in our Annual Report on Form 10-K
as filed with the SEC on March 24, 2008.
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 March 31,
2008, we had cash, cash equivalents and short-term investments of $107.5
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.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
As
required by Rule 13a15(b) of the 1934 Act, the Companys 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
the Companys disclosure controls and procedures. Based on that evaluation, the
Companys principal executive officer and principal financial officer concluded
that the Companys disclosure controls and procedures are effective at the
reasonable assurance level in ensuring that information required to be
disclosed by the Company in the reports that it files or submits 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, the Companys 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, the Companys 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, the Companys internal control over
financial reporting.
13
Sirtris
Pharmaceuticals, Inc.
(A
development-stage company)
Notes
to Consolidated Financial Statements
(
in thousands, except share and per share amounts
)
(Unaudited)
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 proposed acquisition by SKB, a wholly-owned subsidiary of GSK
Failure to complete our proposed acquisition by SKB could
adversely affect our stock price and future business and operations.
On April 22, 2008,
the Company entered into the Merger Agreement with SKB and the Purchaser,
pursuant to which, among other things, the Purchaser agreed to commence a
tender offer for all the outstanding shares of common stock of the Company,
subject to the terms and conditions of the Merger Agreement. SKB is a
wholly-owned subsidiary of GSK. The proposed acquisition by SKB is subject to
the satisfaction of customary closing conditions, including, but not limited
to, approval under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and
the acquisition by SKB of a majority of Sirtriss shares. We cannot assure you
that these conditions will be satisfied or that the merger will be successfully
completed. In the event that the merger is not completed:
·
managements attention may be
diverted from our day-to-day business, we may lose key employees, and our
ongoing business and prospects, as well as relationships with customers and
partners, may be disrupted by resulting uncertainties;
·
we may be required in specific
circumstances to pay a termination fee of up to $22.5 million to SKB;
·
the market price of shares of our common
stock may decline to the extent that the current market price of those shares
reflects a market assumption that the merger will be completed; and
·
we will be required to pay
significant costs related to the merger, such as legal, accounting and advisory
fees.
Any
such events could adversely affect our stock price and harm our business,
financial condition and results of operations.
The restrictive covenants of the merger agreement have
placed, and will continue to place, significant restrictions on our business
operations until the completion of the merger with SKB.
Pursuant to the Merger
Agreement between the Company and SKB, until the completion of the merger with
SKB, the Company is required to conduct its business in the ordinary and usual
course consistent with past practice. In addition, the Company shall not, among
other things, agree to do any of the following without the prior written
consent of SKB:
·
acquire any corporation, partnership
or other business organization or make any capital expenditure above certain
threshold amounts;
·
issue, sell, pledge or dispose of any
shares of the Company or stock options, warrants, calls, commitments or rights
of the Companys capital stock; or
·
enter into, modify, amend or
terminate any contract relating to research, development, clinical trial, or
collaboration with respect to, any product or product candidate relating to the
Companys current research and development.
GSK may not consent to
our taking any of these actions even though our board of directors may believe
that such action is in the best interests of our stockholders.
14
Sirtris
Pharmaceuticals, Inc.
(A
development-stage company)
Notes
to Consolidated Financial Statements
(
in thousands, except share and per share amounts
)
(Unaudited)
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. Results in limited early stage clinical
trials showed SRT501 to be safe and well-tolerated. 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 and two Phase 1b trials with respect to our only clinical
product candidate, SRT501, all of which were conducted outside of the United
States. We 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 with SRT501 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.
We cannot guarantee that we will be able to successfully accomplish this 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, 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
15
Sirtris
Pharmaceuticals, Inc.
(A
development-stage company)
Notes
to Consolidated Financial Statements
(
in thousands, except share and per share amounts
)
(Unaudited)
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.
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.
16
Sirtris
Pharmaceuticals, Inc.
(A
development-stage company)
Notes
to Consolidated Financial Statements
(
in thousands, except share and per share amounts
)
(Unaudited)
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, 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.
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.
17
Sirtris
Pharmaceuticals, Inc.
(A
development-stage company)
Notes
to Consolidated Financial Statements
(
in thousands, except share and per share amounts
)
(Unaudited)
We may encounter difficulties in managing our growth, which
could adversely affect our operations.
Since our inception in
2004, we have grown to approximately 60 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 March 31,
2008, we had an accumulated deficit of $68.7 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 early 2010. 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;
·
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.
18
Sirtris
Pharmaceuticals, Inc.
(A
development-stage company)
Notes
to Consolidated Financial Statements
(
in thousands, except share and per share amounts
)
(Unaudited)
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 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:
19
Sirtris
Pharmaceuticals, Inc.
(A
development-stage company)
Notes
to Consolidated Financial Statements
(
in thousands, except share and per share amounts
)
(Unaudited)
·
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.
The FDA has granted
orphan-drug status to SRT501 for the treatment of MELAS syndrome. We have filed for Orphan Drug status for
SRT501 for MELAS in the European Union and are currently in discussion with
regulatory agencies. 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 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
20
Sirtris
Pharmaceuticals, Inc.
(A
development-stage company)
Notes
to Consolidated Financial Statements
(
in thousands, except share and per share amounts
)
(Unaudited)
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.
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,
21
Sirtris
Pharmaceuticals, Inc.
(A
development-stage company)
Notes
to Consolidated Financial Statements
(
in thousands, except share and per share amounts
)
(Unaudited)
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.
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.
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
22
Sirtris
Pharmaceuticals, Inc.
(A
development-stage company)
Notes
to Consolidated Financial Statements
(
in thousands, except share and per share amounts
)
(Unaudited)
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 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 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);
23
Sirtris
Pharmaceuticals, Inc.
(A
development-stage company)
Notes
to Consolidated Financial Statements
(
in thousands, except share and per share amounts
)
(Unaudited)
·
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
$5.0 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.
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 has been, and may continue to be volatile. Factors giving rise to this volatility may
include:
·
the merger agreement with GSK.
·
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;
·
general market conditions and
comments by securities analysts and investors; and
Fluctuations in our operating losses could adversely affect
the price of our common stock.
Our operating losses may
fluctuate significantly on a quarterly and annual basis. Some of the factors
that may cause our operating
24
Sirtris
Pharmaceuticals, Inc.
(A
development-stage company)
Notes
to Consolidated Financial Statements
(
in thousands, except share and per share amounts
)
(Unaudited)
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 and annual 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 has been and may continue to 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 are able to sell in the public
market. 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 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.
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.
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 are required to devote a substantial amount of time to these
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
25
Sirtris
Pharmaceuticals, Inc.
(A
development-stage company)
Notes
to Consolidated Financial Statements
(
in thousands, except share and per share amounts
)
(Unaudited)
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 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.
Item 2. Unregistered Sales of
Equity Securities and Use of Proceeds
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
26
Sirtris
Pharmaceuticals, Inc.
(A
development-stage company)
Notes
to Consolidated Financial Statements
(
in thousands, except share and per share amounts
)
(Unaudited)
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 $30.9 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
SIGNATURES
Pursuant to the
requirements of Section 13 or 15(d) of the Securities Exchange Act of
1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
|
|
SIRTRIS
PHARMACEUTICALS, INC.
|
|
|
|
|
|
|
|
By:
|
/s/ Christoph Westphal
|
|
|
Christoph Westphal
|
|
|
President and Chief
Executive Officer
(principal executive officer)
|
|
|
|
|
|
|
|
By:
|
/s/ Garen Bohlin
|
|
|
Garen Bohlin
|
|
|
Chief Operating Officer
(principal financial officer)
|
|
|
|
|
|
|
Date: May 14, 2008
|
|
|
28
EXHIBIT
INDEX
Exhibit
No.
|
|
Description
|
|
|
|
10.1
|
|
Amendment to Warrant
issued to ARE-770/784/790 Memorial Drive, LLC, dated April 17, 2008.
|
|
|
|
10.2
|
|
Amendment
to Warrant issued to Hercules Technology Growth Capital, Inc. dated April 17,
2008.
|
|
|
|
31.1
|
|
Certification of Chief
Executive Officer pursuant to Exchange Act rules 13a-14 or 15d-14.
|
|
|
|
31.2
|
|
Certification of Chief
Operating Officer pursuant to Exchange Act rules 13a-14 or 15d-14.
|
|
|
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32.1
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Certifications of Chief
Executive Officer and Chief Operating Officer pursuant to Exchange Act
rules 13a-14(b) or 15d-14(b) and 18 U.S.C. Section 1350.
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29
Sierra Natl BK Tehachapi Calif (MM) (NASDAQ:SIRT)
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