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þ
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QUARTERLY REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
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o
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TRANSITION REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
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Delaware
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30-0520478
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(State
or other jurisdiction of
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(I.R.S.
employer
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|
incorporation
or organization)
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identification
no.)
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4520
East-West Highway, Suite 300
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(301)
961-3400
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Bethesda,
MD 20814
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(Registrant’s
telephone number,
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(Address
of principal executive offices,
|
including
area code)
|
|
including
zip code)
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|
Large
accelerated filer o
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Accelerated
filer þ
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Non
accelerated filer o
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Smaller
reporting company o
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|||
(Do
not check if a smaller reporting
company)
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Page
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Part
I. FINANCIAL INFORMATION
|
|||
Item
1.
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Condensed
Consolidated Financial Statements (unaudited)
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1
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|
Condensed
Consolidated Balance Sheets as of June 30, 2010 and December 31,
2009
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1
|
||
Condensed
Consolidated Statements of Operations and Comprehensive Income (Loss) for
the Three and Six Months Ended June 30, 2010 and 2009
|
2
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||
Condensed
Consolidated Statement of Changes in Stockholders’ Equity for the Six
Months Ended June
30, 2010
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3
|
||
Condensed
Consolidated Statements of Cash Flows for the Six Months Ended June 30,
2010 and 2009
|
4
|
||
Notes
to Condensed Consolidated Financial Statements
|
5
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||
Item
2.
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Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
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20
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|
Item
3.
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Quantitative
and Qualitative Disclosures about Market Risk
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30
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|
Item
4.
|
Controls
and Procedures
|
30
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Part
II. OTHER INFORMATION
|
|||
Item
1.
|
Legal
Proceedings
|
32
|
|
Item
1A.
|
Risk
Factors
|
32
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|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
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32
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|
Item
3.
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Defaults
Upon Senior Securities
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32
|
|
Item
4.
|
Reserved
|
32
|
|
Item
6.
|
Exhibits
|
33
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|
SIGNATURES
|
34
|
||
INDEX
TO EXHIBITS
|
June
30,
|
December
31,
|
|||||||
2010
|
2009
|
|||||||
ASSETS:
|
||||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$ | 42,293 | $ | 26,714 | ||||
Investments,
current
|
56,163 | 72,434 | ||||||
Product
royalties receivable
|
9,612 | 11,023 | ||||||
Unbilled
accounts receivable
|
16 | 644 | ||||||
Accounts
receivable, net
|
889 | 512 | ||||||
Deferred
tax assets, net
|
135 | 315 | ||||||
Prepaid
expenses and other current assets
|
2,209 | 3,137 | ||||||
Total
current assets
|
111,317 | 114,779 | ||||||
Investments,
non-current
|
15,935 | 19,167 | ||||||
Property
and equipment, net
|
2,117 | 2,242 | ||||||
Deferred
tax assets, non-current
|
4,255 | 3,995 | ||||||
Other
assets
|
3,551 | 4,788 | ||||||
Total
assets
|
$ | 137,175 | $ | 144,971 | ||||
LIABILITIES
AND STOCKHOLDERS' EQUITY:
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$ | 2,335 | $ | 3,195 | ||||
Accrued
expenses
|
7,941 | 6,545 | ||||||
Deferred
revenue, current
|
4,298 | 10,565 | ||||||
Income
taxes payable
|
428 | 349 | ||||||
Total
current liabilities
|
15,002 | 20,654 | ||||||
Deferred
revenue, non-current
|
8,296 | 8,643 | ||||||
Other
liabilities
|
2,098 | 2,121 | ||||||
Total
liabilities
|
25,396 | 31,418 | ||||||
Commitments
(Note 7)
|
||||||||
Stockholders'
equity:
|
||||||||
Preferred
stock, $0.01 par value; 5,000,000 shares authorized at June 30, 2010 and
December 31, 2009; no shares issued and outstanding at June 30,
2010 and December 31, 2009
|
- | - | ||||||
Class
A common stock, $0.01 par value; 270,000,000 shares authorized at June 30,
2010 and December 31, 2009; 15,657,937 and 15,655,730 shares issued
and outstanding at June 30, 2010 and December 31, 2009,
respectively
|
156 | 156 | ||||||
Class
B common stock, $0.01 par value; 75,000,000 shares authorized at June 30,
2010 and December 31, 2009; 26,191,050 shares issued and
outstanding at June 30, 2010 and December 31, 2009
|
262 | 262 | ||||||
Additional
paid-in capital
|
99,346 | 98,636 | ||||||
Accumulated
other comprehensive income
|
277 | 484 | ||||||
Retained
earnings
|
11,738 | 14,015 | ||||||
Total
stockholders' equity
|
111,779 | 113,553 | ||||||
Total
liabilities and stockholders' equity
|
$ | 137,175 | $ | 144,971 |
Three
Months Ended June 30,
|
Six
Months Ended June 30,
|
|||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
Revenues:
|
||||||||||||||||
Research
and development revenue
|
$ | 2,789 | $ | 7,395 | $ | 6,846 | $ | 12,921 | ||||||||
Product
royalty revenue
|
9,612 | 8,914 | 19,385 | 17,860 | ||||||||||||
Co-promotion
revenue
|
1,220 | 1,244 | 2,075 | 2,140 | ||||||||||||
Contract
and collaboration revenue
|
154 | 152 | 305 | 298 | ||||||||||||
Total
revenues
|
13,775 | 17,705 | 28,611 | 33,219 | ||||||||||||
Operating
expenses:
|
||||||||||||||||
Research
and development
|
4,854 | 9,621 | 10,220 | 19,586 | ||||||||||||
General
and administrative
|
6,604 | 2,924 | 12,363 | 6,379 | ||||||||||||
Selling
and marketing
|
2,313 | 2,188 | 4,500 | 4,700 | ||||||||||||
Milestone
royalties - related parties
|
- | 375 | - | 875 | ||||||||||||
Product
royalties - related parties
|
1,709 | 1,583 | 3,446 | 3,173 | ||||||||||||
Total
operating expenses
|
15,480 | 16,691 | 30,529 | 34,713 | ||||||||||||
Income
(loss) from operations
|
(1,705 | ) | 1,014 | (1,918 | ) | (1,494 | ) | |||||||||
Non-operating
income (expense):
|
||||||||||||||||
Interest
income
|
177 | 219 | 388 | 531 | ||||||||||||
Other
income (expense), net
|
(135 | ) | (608 | ) | (227 | ) | 214 | |||||||||
Total
non-operating income (expense), net
|
42 | (389 | ) | 161 | 745 | |||||||||||
Income
(loss) before income taxes
|
(1,663 | ) | 625 | (1,757 | ) | (749 | ) | |||||||||
Income
tax provision
|
(315 | ) | (863 | ) | (520 | ) | (1,264 | ) | ||||||||
Net
loss
|
$ | (1,978 | ) | $ | (238 | ) | $ | (2,277 | ) | $ | (2,013 | ) | ||||
Net
loss per share:
|
||||||||||||||||
Basic
net loss per share
|
$ | (0.05 | ) | $ | (0.01 | ) | $ | (0.05 | ) | $ | (0.05 | ) | ||||
Diluted
net loss per share
|
$ | (0.05 | ) | $ | (0.01 | ) | $ | (0.05 | ) | $ | (0.05 | ) | ||||
Weighted
average common shares outstanding - basic
|
41,848 | 41,844 | 41,847 | 41,844 | ||||||||||||
Weighted
average common shares outstanding - diluted
|
41,848 | 41,844 | 41,847 | 41,844 | ||||||||||||
Comprehensive
income (loss):
|
||||||||||||||||
Net
loss
|
$ | (1,978 | ) | $ | (238 | ) | $ | (2,277 | ) | $ | (2,013 | ) | ||||
Other
comprehensive income (loss):
|
||||||||||||||||
Unrealized
gain (loss) on investments, net of tax effect
|
10 | (7 | ) | (7 | ) | (72 | ) | |||||||||
Foreign
currency translation
|
(220 | ) | 340 | (200 | ) | 137 | ||||||||||
Comprehensive
income (loss)
|
$ | (2,188 | ) | $ | 95 | $ | (2,484 | ) | $ | (1,948 | ) |
Accumulated
|
||||||||||||||||||||||||||||||||
Class
A
|
Class
B
|
Additional
|
Other
|
Total
|
||||||||||||||||||||||||||||
Common
Stock
|
Common
Stock
|
Paid-In
|
Comprehensive
|
Retained
|
Stockholders'
|
|||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Income
|
Earnings
|
Equity
|
|||||||||||||||||||||||||
Balance
at December 31, 2009
|
15,655,730 | $ | 156 | 26,191,050 | $ | 262 | $ | 98,636 | $ | 484 | $ | 14,015 | $ | 113,553 | ||||||||||||||||||
Employee
stock option expense
|
- | - | - | - | 702 | - | - | 702 | ||||||||||||||||||||||||
Stock
issued under employee stock purchase plan
|
2,207 | - | - | - | 8 | - | - | 8 | ||||||||||||||||||||||||
Foreign
currency translation
|
- | - | - | - | - | (200 | ) | - | (200 | ) | ||||||||||||||||||||||
Unrealized
loss on investments, net of tax effect
|
- | - | - | - | - | (7 | ) | - | (7 | ) | ||||||||||||||||||||||
Net
loss
|
- | - | - | - | - | - | (2,277 | ) | (2,277 | ) | ||||||||||||||||||||||
Balance
at June 30, 2010
|
15,657,937 | $ | 156 | 26,191,050 | $ | 262 | $ | 99,346 | $ | 277 | $ | 11,738 | $ | 111,779 |
Six
Months Ended June 30,
|
||||||||
2010
|
2009
|
|||||||
Cash
flows from operating activities:
|
||||||||
Net
loss
|
$ | (2,277 | ) | $ | (2,013 | ) | ||
Adjustments
to reconcile net loss to net cash provided by (used in) operating
activities:
|
||||||||
Depreciation
and amortization
|
459 | 309 | ||||||
Deferred
tax provision
|
(76 | ) | 738 | |||||
Stock-based
compensation
|
702 | 188 | ||||||
Amortization
of premiums on investments
|
869 | 508 | ||||||
Unrealized
gain on trading securities
|
- | (2,611 | ) | |||||
Unrealized
loss on settlement rights of auction rate securities
|
- | 2,362 | ||||||
Realized
gain on trading securities
|
(1,086 | ) | - | |||||
Realized
loss on settlement rights of auction rate securities
|
1,086 | - | ||||||
Changes
in operating assets and liabilities:
|
||||||||
Accounts
receivable
|
(377 | ) | (26 | ) | ||||
Unbilled
accounts receivable
|
628 | 750 | ||||||
Product
royalties receivable
|
1,411 | 812 | ||||||
Income
taxes payable
|
79 | (936 | ) | |||||
Accounts
payable
|
(887 | ) | 601 | |||||
Accrued
expenses
|
1,376 | 1,009 | ||||||
Deferred
revenue
|
(6,806 | ) | 9,445 | |||||
Other
assets and liabilities, net
|
927 | (123 | ) | |||||
Net
cash provided by (used in) operating activities
|
(3,972 | ) | 11,013 | |||||
Cash
flows from investing activities:
|
||||||||
Purchases
of investments
|
(40,534 | ) | (90,882 | ) | ||||
Proceeds
from sales of investments
|
12,000 | 9,504 | ||||||
Maturities
of investments
|
48,242 | 52,760 | ||||||
Purchases
of property and equipment
|
(157 | ) | (308 | ) | ||||
Purchase
of intangible assets
|
- | (2,919 | ) | |||||
Net
cash provided by (used in) investing activities
|
19,551 | (31,845 | ) | |||||
Cash
flows from financing activities:
|
||||||||
Proceeds
from employee stock purchase plan
|
8 | 9 | ||||||
Net
cash provided by financing activities
|
8 | 9 | ||||||
Effect
of exchange rates on cash and cash equivalents
|
(8 | ) | 184 | |||||
Net
increase (decrease) in cash and cash equivalents
|
15,579 | (20,639 | ) | |||||
Cash
and cash equivalents at beginning of period
|
26,714 | 62,562 | ||||||
Cash
and cash equivalents at end of period
|
$ | 42,293 | $ | 41,923 |
Three
Months Ended June 30,
|
Six
Months Ended June 30,
|
|||||||||||||||
(in
thousands, except per share data)
|
2010
|
2009
|
2010
|
2009
|
||||||||||||
Basic
net loss per share:
|
||||||||||||||||
Net
loss
|
$ | (1,978 | ) | $ | (238 | ) | $ | (2,277 | ) | $ | (2,013 | ) | ||||
Weighted
average class A and B common shares
|
||||||||||||||||
outstanding
|
41,848 | 41,844 | 41,847 | 41,844 | ||||||||||||
Basic
net loss per share
|
$ | (0.05 | ) | $ | (0.01 | ) | $ | (0.05 | ) | $ | (0.05 | ) | ||||
Diluted
net loss per share:
|
||||||||||||||||
Net
loss
|
$ | (1,978 | ) | $ | (238 | ) | $ | (2,277 | ) | $ | (2,013 | ) | ||||
Weighted
average class A and B common shares
|
||||||||||||||||
outstanding
for diluted net income per share
|
41,848 | 41,844 | 41,847 | 41,844 | ||||||||||||
Diluted
net loss per share
|
$ | (0.05 | ) | $ | (0.01 | ) | $ | (0.05 | ) | $ | (0.05 | ) |
June
30,
|
||||||||
(In
thousands)
|
2010
|
2009
|
||||||
Employee
stock options
|
1,400 | 670 | ||||||
Non-employee
stock options
|
450 | 450 |
June
30, 2010
|
||||||||||||||||
Unrealized
|
Unrealized
|
|||||||||||||||
(In
thousands)
|
Cost
|
Gains
|
Losses
|
Fair
Value
|
||||||||||||
Current:
|
||||||||||||||||
U.S.
Treasury bills and notes
|
$ | 1,004 | $ | - | $ | - | $ | 1,004 | ||||||||
U.S.
commercial paper
|
5,181 | 2 | - | 5,183 | ||||||||||||
U.S.
government securities
|
13,016 | 12 | (5 | ) | 13,023 | |||||||||||
Municipal
securities
|
16,600 | 6 | (9 | ) | 16,597 | |||||||||||
Certificates
of deposits
|
1,750 | 1 | - | 1,751 | ||||||||||||
Corporate
bonds
|
18,585 | 27 | (7 | ) | 18,605 | |||||||||||
Total
|
$ | 56,136 | $ | 48 | $ | (21 | ) | $ | 56,163 | |||||||
Non-current:
|
||||||||||||||||
U.S.
government securities
|
$ | 6,703 | $ | 5 | $ | (7 | ) | $ | 6,701 | |||||||
Municipal
securities
|
3,358 | 8 | - | 3,366 | ||||||||||||
Certificates
of deposits
|
250 | - | (1 | ) | 249 | |||||||||||
Corporate
bonds
|
5,625 | - | (6 | ) | 5,619 | |||||||||||
Total
|
$ | 15,936 | $ | 13 | $ | (14 | ) | $ | 15,935 |
December
31, 2009
|
||||||||||||||||
Unrealized
|
Unrealized
|
|||||||||||||||
(In
thousands)
|
Cost
|
Gains
|
Losses
|
Fair
Value
|
||||||||||||
Current:
|
||||||||||||||||
U.S.
Treasury bills and notes
|
$ | 2,999 | $ | - | $ | - | $ | 2,999 | ||||||||
U.S.
commercial paper
|
1,000 | - | - | 1,000 | ||||||||||||
U.S.
government securities
|
26,020 | 16 | (6 | ) | 26,030 | |||||||||||
Municipal
securities
|
25,339 | 4 | (7 | ) | 25,336 | |||||||||||
Certificates
of deposits
|
1,250 | - | (1 | ) | 1,249 | |||||||||||
Corporate
bonds
|
15,782 | 38 | - | 15,820 | ||||||||||||
Total
|
$ | 72,390 | $ | 58 | $ | (14 | ) | $ | 72,434 | |||||||
Non-current:
|
||||||||||||||||
U.S.
government securities
|
$ | 6,065 | $ | 7 | $ | (12 | ) | $ | 6,060 | |||||||
Municipal
securities
|
1,802 | 4 | - | 1,806 | ||||||||||||
Certificates
of deposits
|
500 | - | (2 | ) | 498 | |||||||||||
Corporate
bonds
|
1,891 | 1 | (3 | ) | 1,889 | |||||||||||
Auction
rate securities
|
10,000 | - | (1,086 | ) | 8,914 | |||||||||||
Total
|
$ | 20,258 | $ | 12 | $ | (1,103 | ) | $ | 19,167 |
Fair Value Measurements at Reporting Date Using
|
||||||||||||||||
June 30, 2010
|
Quoted Prices in
Active Markets
for identical
Assets
|
Significant
Other
Observable
Inputs
|
Significant
Unobservable
Inputs
|
|||||||||||||
(In
thousands)
|
(Level
1)
|
(Level
2)
|
(Level
3)
|
Total
|
||||||||||||
U.S.
Treasury bills and notes
|
$ | 1,004 | $ | - | $ | - | $ | 1,004 | ||||||||
U.S.
government securities
|
19,723 | - | - | 19,723 | ||||||||||||
U.S.
commercial paper
|
- | 5,183 | - | 5,183 | ||||||||||||
Corporate
bonds
|
24,225 | - | - | 24,225 | ||||||||||||
Municipal
securities
|
19,963 | - | - | 19,963 | ||||||||||||
Certificates
of deposits
|
- | 2,000 | - | 2,000 | ||||||||||||
Total
assets measured at fair value
|
$ | 64,915 | $ | 7,183 | $ | - | $ | 72,098 |
Fair Value Measurements at Reporting Date Using
|
||||||||||||||||
December 31, 2009
|
Quoted Prices in
Active Markets
for identical
Assets
|
Significant
Other
Observable
Inputs
|
Significant
Unobservable
Inputs
|
|||||||||||||
(In
thousands)
|
(Level
1)
|
(Level
2)
|
(Level
3)
|
Total
|
||||||||||||
U.S.
Treasury bills and notes
|
$ | 2,999 | $ | - | $ | - | $ | 2,999 | ||||||||
U.S.
government securities
|
32,090 | - | - | 32,090 | ||||||||||||
U.S.
commercial paper
|
- | 1,000 | - | 1,000 | ||||||||||||
Corporate
bonds
|
17,709 | - | - | 17,709 | ||||||||||||
Municipal
securities
|
27,142 | - | - | 27,142 | ||||||||||||
Auction
rate securities
|
- | - | 8,914 | 8,914 | ||||||||||||
Settlement
rights for auction rate securities*
|
- | - | 1,086 | 1,086 | ||||||||||||
Certificates
of deposits
|
- | 1,747 | - | 1,747 | ||||||||||||
Total
assets measured at fair value
|
$ | 79,940 | $ | 2,747 | $ | 10,000 | $ | 92,687 |
June
30,
|
December
31,
|
|||||||
(In
thousands)
|
2010
|
2009
|
||||||
Research
and development costs
|
$ | 2,500 | $ | 3,624 | ||||
Employee
compensation
|
1,473 | 879 | ||||||
Selling
and marketing costs
|
129 | 731 | ||||||
Other
accrued expenses
|
3,839 | 1,311 | ||||||
Total
|
$ | 7,941 | $ | 6,545 |
(In
thousands)
|
||||
2010
(July - December)
|
$ | 715 | ||
2011
|
1,169 | |||
2012
|
966 | |||
2013
|
994 | |||
2014
|
1,024 | |||
2015
and thereafter
|
2,275 | |||
Total
minimum lease payments
|
$ | 7,143 |
Three
Months Ended June 30,
|
Six
Months Ended June 30,
|
|||||||||||||||
(In
thousands)
|
2010
|
2009
|
2010
|
2009
|
||||||||||||
Clinical
supplies
|
$ | 91 | $ | 577 | $ | 203 | $ | 1,620 | ||||||||
Other
research and development services
|
83 | 3,034 | 147 | 3,039 | ||||||||||||
$ | 174 | $ | 3,611 | $ | 350 | $ | 4,659 |
June
30,
|
December
31,
|
|||||||
(In
thousands)
|
2010
|
2009
|
||||||
Deferred
revenue, current
|
$ | 432 | $ | 431 | ||||
Deferred
revenue, non-current
|
6,035 | 6,256 | ||||||
$ | 6,467 | $ | 6,687 |
Amount
Deferred at
December 31,
|
Cash Received
for the Six
Months Ended
June 30,
|
Revenue
Recognized for
the Six Months
Ended June 30,
|
Foreign Currency
Effects for the Six
Months Ended June
30,
|
Amount
Deferred at
June 30,
|
||||||||||||||||
(In
thousands)
|
2009
|
2010
|
2010
|
2010
|
2010
|
|||||||||||||||
Collaboration
revenue:
|
||||||||||||||||||||
Up-front
payment associated with the Company's
|
||||||||||||||||||||
obligation
to participate in joint committees
|
$ | 812 | $ | - | $ | 23 | $ | 33 | $ | 822 | ||||||||||
Research
and development revenue:
|
||||||||||||||||||||
Up-front
payment
|
$ | 3,991 | $ | - | $ | 2,313 | $ | 93 | $ | 1,771 | ||||||||||
Development
milestone payment
|
$ | 3,366 | - | 1,951 | 78 | $ | 1,493 | |||||||||||||
Total
|
$ | 7,357 | $ | - | $ | 4,264 | $ | 171 | $ | 3,264 |
Amount
Deferred at
December 31,
|
Cash Received
for the Six
Months Ended
June 30,
|
Revenue
Recognized for
the Six Months
Ended June 30,
|
Change in Accounts
Receivable for the
Six Months Ended
June 30,
|
Amount
Deferred at
June 30,
|
||||||||||||||||
(In
thousands)
|
2009
|
2010
|
2010
|
2010*
|
2010
|
|||||||||||||||
Collaboration
revenue:
|
||||||||||||||||||||
Up-front
payment associated with the Company's
|
||||||||||||||||||||
obligation
to participate in joint committees
|
$ | 1,617 | $ | - | $ | 73 | $ | - | $ | 1,544 | ||||||||||
Research
and development revenue:
|
||||||||||||||||||||
Reimbursement
of research and development expenses
|
$ | 2,734 | $ | 965 | $ | 2,573 | $ | (628 | ) | $ | 498 | |||||||||
Product
royalty revenue
|
$ | - | $ | 20,796 | $ | 19,385 | $ | (1,411 | ) | $ | - | |||||||||
Co-promotion
revenue
|
$ | - | $ | 2,028 | $ | 2,075 | $ | 47 | $ | - |
Shares
|
Weighted Average
Exercise Price Per
Share
|
Weighted Average
Remaining
Contractual Term
(Years)
|
Aggregate
Intrinsic Value
|
|||||||||||||
Options
outstanding, December 31, 2009
|
358,700 | $ | 10.43 | |||||||||||||
Options
expired
|
(13,600 | ) | 10.00 | |||||||||||||
Options
outstanding, June 30, 2010
|
345,100 | 10.44 | 3.62 | $ | - | |||||||||||
Options
exercisable, June 30, 2010
|
345,100 | 10.44 | 3.62 | $ | - |
Shares
|
Weighted Average
Exercise Price Per
Share
|
Weighted Average
Remaining
Contractual Term
(Years)
|
Aggregate
Intrinsic Value
|
|||||||||||||
Options
outstanding, December 31, 2009
|
509,800 | $ | 8.58 | |||||||||||||
Options
granted
|
546,000 | 3.77 | ||||||||||||||
Options
forfeited
|
(3,000 | ) | 14.12 | |||||||||||||
Options
outstanding, June 30, 2010
|
1,052,800 | 6.07 | 8.89 | $ | - | |||||||||||
Options
exercisable, June 30, 2010
|
405,617 | 7.42 | 8.44 | $ | - |
(In thousands)
|
Americas
|
Europe
|
Asia
|
Intercompany
Eliminations
|
Consolidated
|
|||||||||||||||
Three
Months Ended June 30, 2010
|
||||||||||||||||||||
Research
and development revenue
|
$ | 1,269 | $ | - | $ | 1,520 | $ | - | $ | 2,789 | ||||||||||
Product
royalty revenue
|
9,612 | - | - | - | 9,612 | |||||||||||||||
Co-promotion
revenue
|
1,220 | - | - | - | 1,220 | |||||||||||||||
Contract
and collaboration revenue
|
141 | - | 285 | (272 | ) | 154 | ||||||||||||||
Total
revenues
|
12,242 | - | 1,805 | (272 | ) | 13,775 | ||||||||||||||
Research
and development expenses
|
1,996 | 142 | 2,988 | (272 | ) | 4,854 | ||||||||||||||
Depreciation
and amortization
|
222 | 3 | 6 | - | 231 | |||||||||||||||
Other
operating expenses
|
9,707 | 468 | 220 | - | 10,395 | |||||||||||||||
Income
(loss) from operations
|
317 | (613 | ) | (1,409 | ) | - | (1,705 | ) | ||||||||||||
Interest
income
|
254 | - | 1 | (78 | ) | 177 | ||||||||||||||
Other
non-operating income (expense), net
|
3 | (49 | ) | (167 | ) | 78 | (135 | ) | ||||||||||||
Income
(loss) before income taxes
|
$ | 574 | $ | (662 | ) | $ | (1,575 | ) | $ | - | $ | (1,663 | ) | |||||||
Capital
expenditures
|
$ | 63 | $ | 1 | $ | (1 | ) | $ | - | $ | 63 | |||||||||
Three
Months Ended June 30, 2009
|
||||||||||||||||||||
Research
and development revenue
|
$ | 3,825 | $ | - | $ | 3,570 | $ | - | $ | 7,395 | ||||||||||
Product
royalty revenue
|
8,914 | - | - | - | 8,914 | |||||||||||||||
Co-promotion
revenue
|
1,244 | - | - | - | 1,244 | |||||||||||||||
Contract
and collaboration revenue
|
142 | - | 220 | (210 | ) | 152 | ||||||||||||||
Total
revenues
|
14,125 | - | 3,790 | (210 | ) | 17,705 | ||||||||||||||
Research
and development expenses
|
5,807 | 177 | 3,847 | (210 | ) | 9,621 | ||||||||||||||
Depreciation
and amortization
|
182 | 3 | 2 | - | 187 | |||||||||||||||
Other
operating expenses
|
6,154 | 302 | 427 | - | 6,883 | |||||||||||||||
Income
(loss) from operations
|
1,982 | (482 | ) | (486 | ) | - | 1,014 | |||||||||||||
Interest
income
|
292 | - | (1 | ) | (72 | ) | 219 | |||||||||||||
Other
non-operating income (expense), net
|
(36 | ) | (334 | ) | (310 | ) | 72 | (608 | ) | |||||||||||
Income
(loss) before income taxes
|
$ | 2,238 | $ | (816 | ) | $ | (797 | ) | $ | - | $ | 625 | ||||||||
Capital
expenditures
|
$ | 3,068 | $ | 3 | $ | 29 | $ | - | $ | 3,100 |
(In thousands)
|
Americas
|
Europe
|
Asia
|
Intercompany
Eliminations
|
Consolidated
|
|||||||||||||||
Six
Months Ended June 30, 2010
|
||||||||||||||||||||
Research
and development revenue
|
$ | 2,573 | $ | - | $ | 4,273 | $ | - | $ | 6,846 | ||||||||||
Product
royalty revenue
|
19,385 | - | - | - | 19,385 | |||||||||||||||
Co-promotion
revenue
|
2,075 | - | - | - | 2,075 | |||||||||||||||
Contract
and collaboration revenue
|
282 | - | 570 | (547 | ) | 305 | ||||||||||||||
Total
revenues
|
24,315 | - | 4,843 | (547 | ) | 28,611 | ||||||||||||||
Research
and development expenses
|
4,369 | 361 | 6,037 | (547 | ) | 10,220 | ||||||||||||||
Depreciation
and amortization
|
440 | 6 | 13 | - | 459 | |||||||||||||||
Other
operating expenses
|
18,712 | 720 | 418 | - | 19,850 | |||||||||||||||
Income
(loss) from operations
|
794 | (1,087 | ) | (1,625 | ) | - | (1,918 | ) | ||||||||||||
Interest
income
|
527 | - | 2 | (141 | ) | 388 | ||||||||||||||
Other
non-operating income (expense), net
|
(33 | ) | (148 | ) | (187 | ) | 141 | (227 | ) | |||||||||||
Income
(loss) before income taxes
|
$ | 1,288 | $ | (1,235 | ) | $ | (1,810 | ) | $ | - | $ | (1,757 | ) | |||||||
Capital
expenditures
|
$ | 154 | $ | 1 | $ | 2 | $ | - | $ | 157 | ||||||||||
Six
Months Ended June 30, 2009
|
||||||||||||||||||||
Research
and development revenue
|
$ | 8,977 | $ | - | $ | 3,944 | $ | - | $ | 12,921 | ||||||||||
Product
royalty revenue
|
17,860 | - | - | - | 17,860 | |||||||||||||||
Co-promotion
revenue
|
2,140 | - | - | - | 2,140 | |||||||||||||||
Contract
and collaboration revenue
|
283 | - | 435 | (420 | ) | 298 | ||||||||||||||
Total
revenues
|
29,260 | - | 4,379 | (420 | ) | 33,219 | ||||||||||||||
Research
and development expenses
|
13,778 | 329 | 5,899 | (420 | ) | 19,586 | ||||||||||||||
Depreciation
and amortization
|
299 | 6 | 4 | - | 309 | |||||||||||||||
Other
operating expenses
|
12,641 | 630 | 1,547 | - | 14,818 | |||||||||||||||
Income
(loss) from operations
|
2,542 | (965 | ) | (3,071 | ) | - | (1,494 | ) | ||||||||||||
Interest
income
|
651 | - | 2 | (122 | ) | 531 | ||||||||||||||
Other
non-operating income (expense), net
|
208 | (370 | ) | 254 | 122 | 214 | ||||||||||||||
Income
(loss) before income taxes
|
$ | 3,401 | $ | (1,335 | ) | $ | (2,815 | ) | $ | - | $ | (749 | ) | |||||||
Capital
expenditures
|
$ | 3,195 | $ | 3 | $ | 29 | $ | - | $ | 3,227 | ||||||||||
As
of June 30, 2010
|
||||||||||||||||||||
Property
and equipment, net
|
$ | 1,892 | $ | 28 | $ | 197 | $ | - | $ | 2,117 | ||||||||||
Identifiable
assets, net of intercompany loans and investments
|
$ | 129,759 | $ | 6,316 | $ | 3,900 | $ | (2,800 | ) | $ | 137,175 | |||||||||
As
of December 31, 2009
|
||||||||||||||||||||
Property
and equipment, net
|
$ | 2,008 | $ | 34 | $ | 200 | $ | - | $ | 2,242 | ||||||||||
Identifiable
assets, net of intercompany loans and investments
|
$ | 134,714 | $ | 864 | $ | 11,294 | $ | (1,901 | ) | $ | 144,971 |
Three Months Ended
|
||||||||
June 30,
|
||||||||
(In thousands)
|
2010
|
2009
|
||||||
Research
and development revenue
|
$ | 2,789 | $ | 7,395 | ||||
Product
royalty revenue
|
9,612 | 8,914 | ||||||
Co-promotion
revenue
|
1,220 | 1,244 | ||||||
Contract
and collaboration revenue
|
154 | 152 | ||||||
Total
|
$ | 13,775 | $ | 17,705 |
Three Months Ended
|
||||||||
June 30,
|
||||||||
(In thousands)
|
2010
|
2009
|
||||||
Direct
costs:
|
||||||||
Amitiza
|
$ | 3,223 | $ | 7,579 | ||||
Cobiprostone
|
162 | 687 | ||||||
SPI-017
|
733 | 679 | ||||||
Rescula
|
174 | 58 | ||||||
Other
|
21 | 110 | ||||||
Total
|
4,313 | 9,113 | ||||||
Indirect
costs
|
541 | 508 | ||||||
Total
|
$ | 4,854 | $ | 9,621 |
Three Months Ended
|
||||||||
June 30,
|
||||||||
(In thousands)
|
2010
|
2009
|
||||||
Salaries,
benefits and related costs
|
$ | 1,423 | $ | 751 | ||||
Legal,
consulting and other professional expenses
|
3,503 | 911 | ||||||
Other
expenses
|
1,678 | 1,262 | ||||||
Total
|
$ | 6,604 | $ | 2,924 |
Three Months Ended
|
||||||||
June 30,
|
||||||||
(In thousands)
|
2010
|
2009
|
||||||
Interest
income
|
$ | 177 | $ | 219 | ||||
Other
income (expense), net
|
(135 | ) | (608 | ) | ||||
Total
|
$ | 42 | $ | (389 | ) |
Six Months Ended
|
||||||||
June 30,
|
||||||||
(In thousands)
|
2010
|
2009
|
||||||
Research
and development revenue
|
$ | 6,846 | $ | 12,921 | ||||
Product
royalty revenue
|
19,385 | 17,860 | ||||||
Co-promotion
revenue
|
2,075 | 2,140 | ||||||
Contract
and collaboration revenue
|
305 | 298 | ||||||
Total
|
$ | 28,611 | $ | 33,219 |
Six Months Ended
|
||||||||
June 30,
|
||||||||
(In thousands)
|
2010
|
2009
|
||||||
Direct
costs:
|
||||||||
Amitiza
|
$ | 6,997 | $ | 14,350 | ||||
Cobiprostone
|
307 | 1,577 | ||||||
SPI-017
|
1,542 | 2,316 | ||||||
Rescula
|
292 | 58 | ||||||
Other
|
82 | 254 | ||||||
Total
|
9,220 | 18,555 | ||||||
Indirect
costs
|
1,000 | 1,031 | ||||||
Total
|
$ | 10,220 | $ | 19,586 |
Six Months Ended
|
||||||||
June 30,
|
||||||||
(In thousands)
|
2010
|
2009
|
||||||
Salaries,
benefits and related costs
|
$ | 2,668 | $ | 1,909 | ||||
Legal,
consulting and other professional expenses
|
6,738 | 1,989 | ||||||
Other
expenses
|
2,957 | 2,481 | ||||||
Total
|
$ | 12,363 | $ | 6,379 |
Six Months Ended
|
||||||||
June 30,
|
||||||||
(In thousands)
|
2010
|
2009
|
||||||
Interest
income
|
$ | 388 | $ | 531 | ||||
Other
income (expense), net
|
(227 | ) | 214 | |||||
Total
|
$ | 161 | $ | 745 |
(In thousands)
|
Americas
|
Europe
|
Asia
|
Intercompany
Eliminations
|
Consolidated
|
|||||||||||||||
Three
Months Ended June 30, 2010
|
||||||||||||||||||||
Total
revenues
|
$ | 12,242 | $ | - | $ | 1,805 | $ | (272 | ) | $ | 13,775 | |||||||||
Income
(loss) before taxes
|
574 | (662 | ) | (1,575 | ) | - | (1,663 | ) | ||||||||||||
Three
Months Ended June 30, 2009
|
||||||||||||||||||||
Total
revenues
|
$ | 14,125 | $ | - | $ | 3,790 | $ | (210 | ) | $ | 17,705 | |||||||||
Income
(loss) before taxes
|
2,238 | (816 | ) | (797 | ) | - | 625 | |||||||||||||
Six
Months Ended June 30, 2010
|
||||||||||||||||||||
Total
revenues
|
$ | 24,315 | $ | - | $ | 4,843 | $ | (547 | ) | $ | 28,611 | |||||||||
Income
(loss) before taxes
|
1,288 | (1,235 | ) | (1,810 | ) | - | (1,757 | ) | ||||||||||||
Six
Months Ended June 30, 2009
|
||||||||||||||||||||
Total
revenues
|
$ | 29,260 | $ | - | $ | 4,379 | $ | (420 | ) | $ | 33,219 | |||||||||
Income
(loss) before taxes
|
3,401 | (1,335 | ) | (2,815 | ) | - | (749 | ) | ||||||||||||
Identifiable
Assets
|
||||||||||||||||||||
As
of June 30, 2010
|
$ | 129,759 | $ | 6,316 | $ | 3,900 | $ | (2,800 | ) | $ | 137,175 | |||||||||
As
of December 31, 2009
|
134,714 | 864 | 11,294 | (1,901 | ) | 144,971 |
June 30,
|
December 31,
|
|||||||
(In thousands)
|
2010
|
2009
|
||||||
Cash
and cash equivalents
|
$ | 42,293 | $ | 26,714 | ||||
Investments,
current
|
56,163 | 72,434 | ||||||
Investments,
non-current
|
15,935 | 19,167 | ||||||
Total
|
$ | 114,391 | $ | 118,315 |
Six Months Ended June 30,
|
||||||||
(In thousands)
|
2010
|
2009
|
||||||
Cash
provided by (used in):
|
||||||||
Operating
activities
|
$ | (3,972 | ) | $ | 11,013 | |||
Investing
activities
|
19,551 | (31,845 | ) | |||||
Financing
activities
|
8 | 9 | ||||||
Effect
of exchange rates
|
(8 | ) | 184 | |||||
Net
increase in cash and cash equivalents
|
$ | 15,579 | $ | (20,639 | ) |
|
·
|
fund
our share of the ongoing development program of Amitiza in the
U.S.;
|
|
·
|
fund
development and regulatory efforts in Europe and Asia for
lubiprostone;
|
|
·
|
fund
development and regulatory activities for Rescula in the U.S. and
Canada;
|
|
·
|
fund
research and development activities for other prostone compounds,
including cobiprostone and SPI-017;
|
|
·
|
fund
the expansion of our commercialization activities in the U.S. and the
initiation of commercialization efforts in non-U.S.
markets;
|
|
·
|
fund
capital expenditures to support the growth of our
business;
|
|
·
|
fund
activities to resolve our ongoing legal matters;
and
|
|
·
|
fund
the purchase of shares of our class A common stock up to $10.0 million, if
we elect to do so, pursuant to our board-approved stock repurchase
program.
|
|
·
|
the
revenue from Amitiza and Rescula;
|
|
·
|
the
future expenditures we may incur to increase revenue from Amitiza or in
our disputes with Takeda;
|
|
·
|
the
cost and time involved to pursue our research and development
programs;
|
|
·
|
our
ability to establish collaborative arrangements and to enter into
licensing agreements and contractual arrangements with others;
and
|
|
·
|
any
future change in our business
strategy.
|
Exhibit
|
||||
Number
|
Description
|
Reference
|
||
3.1
|
Certificate
of Incorporation
|
Exhibit
3.1 to the Company's Current Report on Form 8-K (filed December 29,
2008)
|
||
3.2
|
Certificate
of Amendment
|
Exhibit
3.2 to the Company's Current Report on Form 8-K (filed December 29,
2008)
|
||
3.3
|
Restated
Bylaws
|
Exhibit
3.3 to the Company's Current Report on Form 8-K (filed December 29,
2008)
|
||
4.1
|
Specimen
Stock Certificate evidencing the shares of class A common
stock
|
Exhibit
4.1 to Registration Statement No. 333-135133, Amendment No. 5 (filed
February 1, 2007)
|
||
31.1
|
Certification
of the Principal Executive Officer, as required by Section 302 of the
Sarbanes-Oxley Act of 2002
|
Included
herewith
|
||
31.2
|
Certification
of the Principal Financial Officer, as required by Section 302 of the
Sarbanes-Oxley Act of 2002
|
Included
herewith
|
||
32.1
|
Certification
of the Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
|
Included
herewith
|
||
32.2
|
Certification
of the Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
|
Included
herewith
|
Sucampo
Pharmaceuticals, Inc.
|
||
August
5, 2010
|
By:
|
/s/ RYUJI
UENO
|
Ryuji
Ueno, M.D., Ph.D., Ph.D.
|
||
Chief
Executive Officer, Chief Scientific Officer and
Chairman
of the Board of Directors
|
||
(Principal
Executive Officer)
|
||
August
5, 2010
|
By:
|
/s/ JAN
SMILEK
|
Jan
Smilek
|
||
Chief
Financial Officer
|
||
(Principal
Financial and Accounting
Officer)
|
Exhibit
|
||||
Number
|
Description
|
Reference
|
||
3.1
|
Certificate
of Incorporation
|
Exhibit
3.1 to the Company's Current Report on Form 8-K (filed December 29,
2008)
|
||
3.2
|
Certificate
of Amendment
|
Exhibit
3.2 to the Company's Current Report on Form 8-K (filed December 29,
2008)
|
||
3.3
|
Restated
Bylaws
|
Exhibit
3.3 to the Company's Current Report on Form 8-K (filed December 29,
2008)
|
||
4.1
|
Specimen
Stock Certificate evidencing the shares of class A common
stock
|
Exhibit
4.1 to Registration Statement No. 333-135133, Amendment No. 5 (filed
February 1, 2007)
|
||
31.1
|
Certification
of the Principal Executive Officer, as required by Section 302 of the
Sarbanes-Oxley Act of 2002
|
Included
herewith
|
||
31.2
|
Certification
of the Principal Financial Officer, as required by Section 302 of the
Sarbanes-Oxley Act of 2002
|
Included
herewith
|
||
32.1
|
Certification
of the Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
|
Included
herewith
|
||
32.2
|
Certification
of the Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
|
Included
herewith
|
1.
|
I
have reviewed this Quarterly Report on Form 10-Q of Sucampo
Pharmaceuticals, Inc.;
|
2.
|
Based
on my knowledge, this report does not contain any untrue statement of a
material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this
report;
|
3.
|
Based
on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the
registrant as of, and for, the periods presented in this
report;
|
4.
|
The
registrant’s other certifying officer(s) and I are responsible for
establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15(d)-15(e)) and internal
control over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d-15(F)) for the registrant and
have:
|
(a)
|
designed
such disclosure controls and procedures or caused such disclosure controls
and procedures to be designed under our supervision, to ensure that
material information relating to the registrant, including its
consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being
prepared;
|
(b)
|
designed
such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial
reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting
principles;
|
(c)
|
evaluated
the effectiveness of the registrant’s disclosure controls and procedures
and presented in this report our conclusions about the effectiveness of
the disclosure controls and procedures, as of the end of the period
covered by this report based on such evaluation;
and
|
(d)
|
disclosed
in this report any change in the registrant’s internal control over
financial reporting that occurred during the registrant’s most recent
fiscal quarter (the registrants fourth fiscal quarter in the case of an
annual report) that has materially affected, or is reasonably likely to
materially affect the registrant’s internal control over financial
reporting; and
|
5.
|
The
registrant’s other certifying officer(s) and I have disclosed, based on
our most recent evaluation of internal control over financial reporting,
to the registrant’s auditors and the audit committee of registrant’s board
of directors (or persons performing the equivalent
functions):
|
(a)
|
all
significant deficiencies and material weaknesses in the design or
operation of internal controls over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record,
process, summarize and report financial information;
and
|
(b)
|
any
fraud, whether or not material, that involves management or other
employees who have a significant role in the registrant’s internal control
over financial
reporting.
|
Date:
August 5, 2010
|
/s/ RYUJI
UENO
|
Ryuji
Ueno, M.D., Ph.D., Ph.D.
|
|
Chief
Executive Officer
|
|
(Principal
Executive Officer)
|
1.
|
I
have reviewed this Quarterly Report on Form 10-Q of Sucampo
Pharmaceuticals, Inc.;
|
2.
|
Based
on my knowledge, this report does not contain any untrue statement of a
material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this
report;
|
3.
|
Based
on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the
registrant as of, and for, the periods presented in this
report;
|
4.
|
The
registrant’s other certifying officer(s) and I are responsible for
establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15(d)-15(e)) and internal
control over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d-15(F)) for the registrant and
have:
|
(a)
|
designed
such disclosure controls and procedures or caused such disclosure controls
and procedures to be designed under our supervision, to ensure that
material information relating to the registrant, including its
consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being
prepared;
|
(b)
|
designed
such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial
reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting
principles;
|
(c)
|
evaluated
the effectiveness of the registrant’s disclosure controls and procedures
and presented in this report our conclusions about the effectiveness of
the disclosure controls and procedures, as of the end of the period
covered by this report based on such evaluation;
and
|
(d)
|
disclosed
in this report any change in the registrant’s internal control over
financial reporting that occurred during the registrant’s most recent
fiscal quarter (the registrants fourth fiscal quarter in the case of an
annual report) that has materially affected, or is reasonably likely to
materially affect the registrant’s internal control over financial
reporting; and
|
5.
|
The
registrant’s other certifying officer(s) and I have disclosed, based on
our most recent evaluation of internal control over financial reporting,
to the registrant’s auditors and the audit committee of registrant’s board
of directors (or persons performing the equivalent
functions):
|
(a)
|
all
significant deficiencies and material weaknesses in the design or
operation of internal controls over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record,
process, summarize and report financial information;
and
|
(b)
|
any
fraud, whether or not material, that involves management or other
employees who have a significant role in the registrant’s internal control
over financial reporting.
|
Date:
August 5, 2010
|
/s/ JAN
SMILEK
|
Jan
Smilek
|
|
Chief
Financial Officer
|
|
(Principal
Financial and Accounting
Officer)
|
|
(1)
|
The
Quarterly Report on Form 10-Q for the period ended June 30, 2010 of the
Company (the “Report”) fully complies with the requirements of Section
13(a) or 15(d) of the Securities Exchange Act of 1934, as amended;
and
|
|
(2)
|
The
information contained in the Report fairly presents, in all material
respects, the financial condition and results of operations of the
Company.
|
Date:
August 5, 2010
|
/s/ RYUJI
UENO
|
Ryuji
Ueno, M.D., Ph.D., Ph.D.
|
|
Chief
Executive Officer
|
|
(Principal
Executive Officer)
|
|
(1)
|
The
Quarterly Report on Form 10-Q for the period ended June 30, 2010 of the
Company (the “Report”) fully complies with the requirements of Section
13(a) or 15(d) of the Securities Exchange Act of 1934, as amended;
and
|
|
(2)
|
The
information contained in the Report fairly presents, in all material
respects, the financial condition and results of operations of the
Company.
|
Date:
August 5, 2010
|
/s/ JAN
SMILEK
|
Jan
Smilek
|
|
Chief
Financial Officer
|
|
(Principal
Financial and Accounting
Officer)
|