CARDIOME PHARMA CORP.
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Date: November 4, 2011
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/s/ CURTIS SIKORSKY
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Curtis Sikorsky
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Chief Financial Officer
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EXHIBIT
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DESCRIPTION OF EXHIBIT
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99.1 |
Management’s Discussion and Analysis of Financial Condition and Results of Operations
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99.2 |
Consolidated Financial Statements
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99.3
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News Release dated November 4, 2011 - Cardiome Reports Third Quarter Results
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99.4
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Material Change Report dated November 4, 2011
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99.5 |
Certificate of Filing - CEO
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99.6 |
Certificate of Filing - CFO
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Project
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Stage of Development
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Current Status
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Cost to
Date (in
millions of
dollars)
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Vernakalant (iv)
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FDA New Drug Application (NDA)
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ACT 5 trial initiated in Q4-2009. Patient enrollment currently suspended.
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$ 100.6
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European Marketing Authorisation Application (MAA)
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Marketing approval received in September 2010 under trade name BRINAVESS™.
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European Comparator (AVRO) Study
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Final results released in Q2-2010.
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Phase 3 Asia Pacific study
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Patient enrollment initiated in Q3-2010.
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Vernakalant (oral)
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Phase 2b Clinical Trial
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Final results released in Q3-2008
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109.5
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Pharmacokinetic/ pharmacodynamics studies
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Phase 1 PK/PD study completed
Additional Phase 1 trial to be initiated in late 2011
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GED-aPC
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Phase 1
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Phase 1 study completed. Results to be released in 2011.
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16.3
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USAMRIID pre-clinical study
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Awaiting final study report
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Current Pre-clinical Projects
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Pre-Clinical Stage
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Pre-clinical studies
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10.6
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(in thousands of dollars)
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For the Three Months
Ended September 30
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For the Nine Months
Ended September 30
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Project
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2011
$
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2010
$
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2011
$
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2010
$
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Vernakalant (oral)
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198
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451
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925
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1,099
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Vernakalant (iv)
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974
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2,461
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4,217
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6,566
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GED-aPC
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26
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43
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285
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713
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Other projects
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2,705
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531
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6,355
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2,544
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Total research and development expenses
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3,903
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3,486
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11,782
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10,922
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Quarter ended
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||||||||||||||||
(In thousands of dollars
except per share amounts)
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September
30, 2011
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June 30,
2011
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March 31,
2011
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December 31,
2010
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||||||||||||
Total revenue
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$ | 274 | $ | 443 | $ | 387 | $ | 374 | ||||||||
Research and development
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3,903 | 4,073 | 3,806 | 4,417 | ||||||||||||
General and administration
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2,764 | 3,466 | 3,224 | 2,740 | ||||||||||||
Net income (loss)
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$ | (7,153 | ) | $ | (7,723 | ) | $ | (7,146 | ) | $ | (7,302 | ) | ||||
Net income (loss) per share
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||||||||||||||||
Basic and diluted
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$ | (0.12 | ) | $ | (0.13 | ) | $ | (0.12 | ) | $ | (0.12 | ) | ||||
(In thousands of dollars
except per share amounts)
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Quarter ended
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|||||||||||||||
September 30,
2010
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June 30,
2010
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March 31,
2010
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December 31,
2009
(Adjusted)(1)
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Total revenue
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$ | 30,221 | $ | 12,424 | $ | 23,045 | $ | 23,438 | ||||||||
Research and development
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3,486 | 3,682 | 3,754 | 5,788 | ||||||||||||
General and administration
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3,505 | 3,272 | 3,358 | 3,367 | ||||||||||||
Net income (loss)
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$ | 22,768 | $ | 4,560 | $ | 15,473 | $ | 12,102 | ||||||||
Net Income (loss) per share
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||||||||||||||||
Basic
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$ | 0.37 | $ | 0.08 | $ | 0.26 | $ | 0.20 | ||||||||
Diluted
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0.37 | 0.07 | 0.26 | 0.20 |
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(1) Adjustments relate to the adoption of U.S. GAAP as our primary reporting standard and U.S. dollars as our reporting currency as of January 1, 2010.
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(in thousands of dollars)
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For the Three Months Ended
September 30,
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For the Nine Month
Ended September 30,
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||||||||||||||
2011
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2010
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2011
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2010
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|||||||||||||
Cash used in operating activities
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$ | (6,402 | ) | $ | (5,009 | ) | $ | (21,702 | ) | $ | (20,698 | ) | ||||
Cash used in investing activities
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(158 | ) | (151 | ) | (943 | ) | (458 | ) | ||||||||
Cash provided by financing activities
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- | 715 | 358 | 27,359 | ||||||||||||
Effect of foreign exchange rate on cash
and cash equivalents
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(209 | ) | 170 | (54 | ) | (41 | ) | |||||||||
Net increase (decrease) in cash and cash
equivalents
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$ | (6,769 | ) | $ | (4,275 | ) | $ | (22,341 | ) | $ | 6,162 |
Contractual Obligations
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Payment due by period
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|||||||||||||||||||||||||||
(In thousands of dollars)
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2011
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2012
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2013
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2014
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2015
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There-
after
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Total
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Long-term debt and interest
expense
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$ | 562 | $ | 2,230 | $ | 2,230 | $ | 2,230 | $ | 2,230 | $ | 27,230 | (1) | $ | 36,712 | |||||||||||||
Operating lease obligations
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404 | 1,637 | 1,643 | 1,257 | 1,185 | 6,434 | 12,560 | |||||||||||||||||||||
Commitments for clinical
research agreements and
other agreements
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212 | 68 | 3 | 2 |
Nil
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Nil
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285 | |||||||||||||||||||||
Other long-term obligations
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7 | 30 | 34 | 6 |
Nil
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Nil
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77 | |||||||||||||||||||||
Total
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$ | 1,185 | $ | 3,965 | $ | 3,910 | $ | 3,495 | $ | 3,415 | $ | 33,664 | $ | 49,634 |
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(1) This includes the $25 million advance, which must be repaid in full by December 31, 2016. We may, at our option, repay all or a portion of this advance prior to December 31, 2016, without premium or penalty.
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CARDIOME PHARMA CORP.
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Consolidated Balance Sheets
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(Unaudited)
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(Expressed in thousands of U.S. dollars, except share amounts)
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(Prepared in accordance with U.S. GAAP)
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September 30,
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December 31,
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|||||||
2011
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2010
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Assets
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||||||||
Current assets:
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Cash and cash equivalents
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$
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54,547
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$
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76,888
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Accounts receivable
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606
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732
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Prepaid expenses and other assets
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681
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1,000
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||||||
55,834
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78,620
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Property and equipment
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2,121
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2,069
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Intangible assets
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1,690
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1,635
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$
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59,645
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$
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82,324
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Liabilities and Stockholders’ Equity
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||||||||
Current liabilities:
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||||||||
Accounts payable and accrued liabilities (note 5)
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$
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3,148
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$
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5,705
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Current portion of deferred leasehold inducement
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114
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216
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3,262
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5,921
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Deferred leasehold inducement
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473
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486
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Long-term debt
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25,000
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25,000
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28,735
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31,407
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Stockholders’ equity:
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Common stock
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Authorized - unlimited number with no par value
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Issued and outstanding – 61,129,091 (2010 - 61,052,362)
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262,097
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261,554
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Additional paid-in capital
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31,934
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30,462
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Deficit
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(281,306
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)
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(259,284
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)
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Accumulated other comprehensive income
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18,185
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18,185
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30,910
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50,917
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$
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59,645
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$
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82,324
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CARDIOME PHARMA CORP.
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Consolidated Statements of Operations and Comprehensive Income (Loss)
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(Unaudited)
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(Expressed in thousands of U.S. dollars, except share and per share amounts)
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(Prepared in accordance with U.S. GAAP)
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Three months ended
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Nine months ended
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September 30,
2011
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September 30,
2010
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September 30,
2011
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September 30,
2010
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Revenue:
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Licensing and other fees
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$ | 91 | $ | 30,000 | $ | 372 | $ | 65,146 | ||||||||
Research collaborative fees
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183 | 221 | 732 | 544 | ||||||||||||
274 | 30,221 | 1,104 | 65,690 | |||||||||||||
Expenses:
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Research and development
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3,903 | 3,486 | 11,782 | 10,922 | ||||||||||||
General and administration
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2,764 | 3,505 | 9,454 | 10,135 | ||||||||||||
Amortization
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271 | 291 | 825 | 890 | ||||||||||||
6,938 | 7,282 | 22,061 | 21,947 | |||||||||||||
Operating income (loss)
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(6,664 | ) | 22,939 | (20,957 | ) | 43,743 | ||||||||||
Other expenses (income):
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Interest expense
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560 | 565 | 1,659 | 1,412 | ||||||||||||
Other income
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(234 | ) | (187 | ) | (626 | ) | (534 | ) | ||||||||
Foreign exchange loss (gain)
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163 | (207 | ) | 32 | 64 | |||||||||||
489 | 171 | 1,065 | 942 | |||||||||||||
Net income (loss) and comprehensive income (loss) for the period
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$ | (7,153 | ) | $ | 22,768 | $ | (22,022 | ) | $ | 42,801 | ||||||
Income (loss) per common share (note 6)
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Basic and Diluted
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$ | (0.12 | ) | $ | 0.37 | $ | (0.36 | ) | $ | 0.70 | ||||||
Weighted average common shares outstanding during the period
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Basic
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61,129,091 | 60,985,176 | 61,124,696 | 60,733,543 | ||||||||||||
Diluted
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61,129,091 | 61,740,580 | 61,124,696 | 61,343,530 | ||||||||||||
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CARDIOME PHARMA CORP.
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Consolidated Statements of Stockholders’ Equity
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For the nine months ended September 30, 2011 and 2010
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(Unaudited)
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(Expressed in thousands of U.S. dollars)
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(Prepared in accordance with U.S. GAAP)
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For the nine months ended September 30, 2011
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Common
stock
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Additional
paid-in capital
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Deficit
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Accumulated
other
comprehensive
income
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Total
stockholders’
equity
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Balance at December 31, 2010
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$ | 261,554 | $ | 30,462 | $ | (259,284 | ) | $ | 18,185 | $ | 50,917 | |||||||||
Net loss
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- | - | (22,022 | ) | - | (22,022 | ) | |||||||||||||
Common stock issued upon exercise of options
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358 | - | - | - | 358 | |||||||||||||||
Reallocation of additional paid-in capital arising from stock-based compensation related to exercise of options
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185 | (185 | ) | - | - | - | ||||||||||||||
Stock option expense recognized
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- | 1,657 | - | - | 1,657 | |||||||||||||||
Balance at September 30, 2011
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$ | 262,097 | $ | 31,934 | $ | (281,306 | ) | $ | 18,185 | $ | 30,910 | |||||||||
For the nine months ended September 30, 2010
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Common
stock
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Additional
paid-in capital
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Deficit
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Accumulated
other
comprehensive
income
|
Total
stockholders’
equity
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|||||||||||||||
Balance at December 31, 2009
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$ | 256,711 | $ | 29,669 | $ | (294,783 | ) | $ | 18,185 | $ | 9,782 | |||||||||
Net income
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- | - | 42,801 | - | 42,801 | |||||||||||||||
Common stock issued upon exercise of options
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2,359 | - | - | - | 2,359 | |||||||||||||||
Reallocation of additional paid-in capital arising from stock-based compensation related to exercise of options
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2,475 | (2,475 | ) | - | - | - | ||||||||||||||
Stock option expense recognized
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- | 2,477 | - | - | 2,477 | |||||||||||||||
Balance at September 30, 2010
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$ | 261,545 | $ | 29,671 | $ | (251,982 | ) | $ | 18,185 | $ | 57,419 |
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CARDIOME PHARMA CORP.
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Consolidated Statements of Cash Flows
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(Unaudited)
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(Expressed in thousands of U.S. dollars)
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(Prepared in accordance with U.S. GAAP)
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Three months ended
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Nine months ended
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September 30,
2011
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September 30,
2010
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September 30,
2011
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September 30,
2010
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Cash flows from operating activities:
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||||||||||||||||
Net income (loss) for the period
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$ | (7,153 | ) | $ | 22,768 | $ | (22,022 | ) | $ | 42,801 | ||||||
Add items not affecting cash:
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||||||||||||||||
Amortization
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271 | 291 | 825 | 890 | ||||||||||||
Stock-based compensation
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636 | 551 | 1,657 | 2,477 | ||||||||||||
Deferred leasehold inducement
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(44 | ) | (50 | ) | (115 | ) | (156 | ) | ||||||||
Unrealized foreign exchange gain
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80 | (119 | ) | (21 | ) | (23 | ) | |||||||||
Changes in operating assets and liabilities:
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||||||||||||||||
Accounts receivable
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642 | (29,502 | ) | 128 | (29,196 | ) | ||||||||||
Prepaid expenses and other assets
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(150 | ) | (28 | ) | 319 | (234 | ) | |||||||||
Accounts payable and accrued liabilities
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(684 | ) | 1,080 | (2,473 | ) | (2,060 | ) | |||||||||
Deferred revenue
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- | - | - | (35,197 | ) | |||||||||||
Net cash used in operating activities
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(6,402 | ) | (5,009 | ) | (21,702 | ) | (20,698 | ) | ||||||||
Cash flows from investing activities:
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||||||||||||||||
Purchase of property and equipment
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(101 | ) | (73 | ) | (634 | ) | (216 | ) | ||||||||
Purchase of intangible assets
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(57 | ) | (78 | ) | (309 | ) | (242 | ) | ||||||||
Net cash used in investing activities
|
(158 | ) | (151 | ) | (943 | ) | (458 | ) | ||||||||
Cash flows from financing activities:
|
||||||||||||||||
Issuance of common stock upon exercise of stock options
|
- | 715 | 358 | 2,359 | ||||||||||||
Proceeds from issuance of long-term debt
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- | - | - | 25,000 | ||||||||||||
Net cash provided by financing activities
|
- | 715 | 358 | 27,359 | ||||||||||||
Effect of foreign exchange rate changes on cash and cash equivalents
|
(209 | ) | 170 | (54 | ) | (41 | ) | |||||||||
Increase (decrease) in cash and cash equivalents during the period
|
(6,769 | ) | (4,275 | ) | (22,341 | ) | 6,162 | |||||||||
Cash and cash equivalents, beginning of period
|
61,316 | 57,707 | 76,888 | 47,270 | ||||||||||||
Cash and cash equivalents, end of period
|
$ | 54,547 | $ | 53,432 | $ | 54,547 | $ | 53,432 | ||||||||
Supplemental cash flow information:
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||||||||||||||||
Interest paid
|
$ | 567 | $ | 573 | $ | 1,677 | $ | 1,423 | ||||||||
Interest received
|
7 | 6 | 18 | 10 |
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CARDIOME PHARMA CORP.
|
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Notes to Consolidated Financial Statements
|
|
(Unaudited)
|
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CARDIOME PHARMA CORP.
|
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Notes to Consolidated Financial Statements
|
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(Unaudited)
|
(a)
|
Fair Value Measurements:
|
(b)
|
Comprehensive Income:
|
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CARDIOME PHARMA CORP.
|
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Notes to Consolidated Financial Statements
|
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(Unaudited)
|
September 30,
|
December 31,
|
|||||||
2011
|
2010
|
|||||||
Trade accounts payable (1)
|
$ | 133 | $ | 603 | ||||
Accrued contract research
|
715 | 2,693 | ||||||
Employee-related accruals
|
937 | 1,051 | ||||||
Other accrued liabilities (1)
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1,363 | 1,358 | ||||||
$ | 3,148 | $ | 5,705 |
(1)
|
Included in trade accounts payable and other accrued liabilities at September 30, 2011 are amounts totaling $210 (December 31, 2010 - $146) owing to a related party (note 8).
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CARDIOME PHARMA CORP.
|
|
Notes to Consolidated Financial Statements
|
|
(Unaudited)
|
For the Three Months Ended
September 30
|
For the Nine Months Ended
September 30
|
|||||||||||||||
2011
|
2010
|
2011
|
2010
|
|||||||||||||
Income (loss) available to common stockholders
|
$ | (7,153 | ) | $ | 22,768 | $ | (22,022 | ) | $ | 42,801 | ||||||
Weighted average number of common shares for basic income (loss) per share
|
61,129,091 | 60,985,176 | 61,124,696 | 60,733,543 | ||||||||||||
Dilutive effect of options
|
- | 755,404 | - | 609,987 | ||||||||||||
Diluted weighted average number of common shares for diluted income (loss) per share
|
61,129,091 | 61,740,580 | 61,124,696 | 61,343,530 | ||||||||||||
Basic and diluted income (loss) per share
|
$ | (0.12 | ) | $ | 0.37 | $ | (0.36 | ) | $ | 0.70 |
|
CARDIOME PHARMA CORP.
|
|
Notes to Consolidated Financial Statements
|
|
(Unaudited)
|
9.
|
Contingencies:
|
(a)
|
The Company may, from time to time, be subject to claims and legal proceedings brought against it in the normal course of business. Such matters are subject to many uncertainties. Management believes that adequate provisions have been made in the accounts where required and the ultimate resolution of such contingencies will not have a material adverse effect on the consolidated financial position of the Company.
|
(b)
|
The Company entered into indemnification agreements with all officers and directors. The maximum potential amount of future payments required under these indemnification agreements is unlimited. However, the Company maintains appropriate liability insurance that limits the exposure and enables the Company to recover any future amounts paid, less any deductible amounts pursuant to the terms of the respective policies, the amounts of which are not considered material.
|
(c)
|
The Company has entered into license and research agreements with third parties that include indemnification provisions that are customary in the industry. These indemnification provisions generally require the Company to compensate the other party for certain damages and costs incurred as a result of third party claims or damages arising from these transactions. In some cases, the maximum potential amount of future payments that could be required under these indemnification provisions is unlimited. These indemnification provisions may survive termination of the underlying agreement. The nature of the indemnification obligations prevents the Company from making a reasonable estimate of the maximum potential amount it could be required to pay. Historically, the Company has not made any indemnification payments under such agreements and no amount has been accrued in the accompanying consolidated financial statements with respect to these indemnification obligations.
|
(d)
|
The Company is party to a proceeding related to its use of certain intellectual property; however, management believes that the possibility of a material loss arising from this matter is not likely.
|
EXHIBIT 99.3
VANCOUVER, British Columbia, Nov. 4, 2011 (GLOBE NEWSWIRE) -- Cardiome Pharma Corp. (Nasdaq:CRME) (TSX:COM) today reported financial results for the third quarter ended September 30, 2011. Amounts, unless specified otherwise, are expressed in U.S. dollars and in accordance with generally accepted accounting principles used in the United States of America (U.S. GAAP).
Summary Results
We recorded a net loss of $7.2 million ($0.12 per common share) for the three months ended September 30, 2011 (Q3-2011), compared to a net income of $22.8 million ($0.37 per common share) for the three months ended September 30, 2010 (Q3-2010). Net expenditures for the current quarter are comprised mainly of clinical development efforts, pre-clinical research projects and other normal operating costs. The net income for Q3-2010 was largely due to recognition of a $30 million milestone payment from Merck related to the marketing approval in Europe of vernakalant (iv), partially offset by normal operating expenses.
Total revenue for Q3-2011 was $0.3 million, a decrease of $29.9 million from $30.2 million in Q3-2010.
Research and development expenditures were $3.9 million for Q3-2011 compared to $3.5 million for Q3-2010. General and administration expenditures for Q3-2011 were $2.7 million compared to $3.5 million for Q3-2010. Interest expense for Q3-2011 and Q3-2010 was $0.6 million.
Stock-based compensation, a non-cash item included in operating expenses for Q3-2011 and Q3-2010, was $0.6 million.
Liquidity and Outstanding Share Capital
At September 30, 2011, the Company had cash and cash equivalents of $54.5 million. As of November 3, 2011, the Company had 61,129,091 common shares issued and outstanding and 4,941,990 common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of CAD $7.06 per share.
Conference Call
Cardiome will hold a teleconference and webcast on Friday, November 4, 2011 at 9:00am Eastern (6:00am Pacific). To access the conference call, please dial 877-670-9780 and reference conference 25290449. There will be a separate dial-in line for analysts on which we will respond to questions at the end of the call. The webcast can be accessed through Cardiome's website at www.cardiome.com.
Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call through December 3, 2011. Please dial 855-859-2056 or 404-537-3406 and enter code 25290449 to access the replay.
About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a product-focused drug development company dedicated to the advancement and commercialization of novel treatments for disorders of the heart and circulatory system. Cardiome is traded on the NASDAQ Global Market (CRME) and the Toronto Stock Exchange (COM). For more information, please visit our web site at www.cardiome.com.
Forward-Looking Statement Disclaimer
Certain statements in this press release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation that may not be based on historical fact, including without limitation statements containing the words "believe", "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect" and similar expressions. Such forward-looking statements or information involve known and unknown risks, uncertainties and other factors that may cause our actual results, events or developments, or industry results, to be materially different from any future results, events or developments expressed or implied by such forward-looking statements or information. Such factors include, among others, our stage of development, lack of product revenues, additional capital requirements, risk associated with the completion of clinical trials and obtaining regulatory approval to market our products, the ability to protect our intellectual property, dependence on collaborative partners and the prospects for negotiating additional corporate collaborations or licensing arrangements and their timing. Specifically, certain risks and uncertainties that could cause such actual events or results expressed or implied by such forward-looking statements and information to differ materially from any future events or results expressed or implied by such statements and information include, but are not limited to, the risks and uncertainties that: we may not be able to successfully develop and obtain regulatory approval for vernakalant (iv) or vernakalant (oral) in the treatment of atrial fibrillation or any other current or future products in our targeted indications; our future operating results are uncertain and likely to fluctuate; we may not be able to raise additional capital; we may not be successful in establishing additional corporate collaborations or licensing arrangements; we may not be able to establish marketing and sales capabilities and the costs of launching our products may be greater than anticipated; we rely on third parties for the continued supply and manufacture of vernakalant (iv) and vernakalant (oral) and we have no experience in commercial manufacturing; we may face unknown risks related to intellectual property matters; we face increased competition from pharmaceutical and biotechnology companies; and other factors as described in detail in our filings with the Securities and Exchange Commission available at www.sec.gov and the Canadian securities regulatory authorities at www.sedar.com. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on our current expectations and we undertake no obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.
CONTACT: Cardiome Investor Relations (604) 676-6993 or Toll Free: 1-800-330-9928 Email: ir@cardiome.com
1.
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Name and Address of Company
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2.
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Date of Material Change
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3.
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News Release
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4.
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Summary of Material Change
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5.
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Full Description of Material Change
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6.
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Reliance on Subsection 7.1(2) or (3) of National Instrument 51-102
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7.
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Omitted Information
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8.
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Executive Officer
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Name:
Title:
Phone No.:
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Curtis Sikorsky
Chief Financial Officer
604-677-6905
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9.
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Date of Report
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Per: |
“Curtis Sikorsky”
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Curtis Sikorsky,
Chief Financial Officer
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1.
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Review: I have reviewed the interim financial report and interim MD&A (together, the “interim filings”) of Cardiome Pharma Corp. (the “issuer”) for the interim period ended September 30, 2011.
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2.
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No misrepresentations: Based on my knowledge, having exercised reasonable diligence, the interim filings do not contain any untrue statement of a material fact or omit to state a material fact required to be stated or that is necessary to make a statement not misleading in light of the circumstances under which it was made, with respect to the period covered by the interim filings.
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3.
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Fair presentation: Based on my knowledge, having exercised reasonable diligence, the interim financial report together with the other financial information included in the interim filings fairly present in all material respects the financial condition, financial performance and cash flows of the issuer, as of the date of and for the periods presented in the interim filings.
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4.
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Responsibility: The issuer’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (DC&P) and internal control over financial reporting (ICFR), as those terms are defined in National Instrument 52-109 Certification of Disclosure in Issuers’ Annual and Interim Filings, for the issuer.
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5.
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Design: Subject to the limitations, if any, described in paragraphs 5.2 and 5.3, the issuer’s other certifying officer(s) and I have, as at the end of the period covered by the interim filings
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(a)
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designed DC&P, or caused it to be designed under our supervision, to provide reasonable assurance that
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(i)
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material information relating to the issuer is made known to us by others, particularly during the period in which the interim filings are being prepared; and
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(ii)
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information required to be disclosed by the issuer in its annual filings, interim filings or other reports filed or submitted by it under securities legislation is recorded, processed, summarized and reported within the time periods specified in securities legislation; and
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(b)
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designed ICFR, or caused it 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 the issuer’s GAAP.
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5.1
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Control framework: The control framework the issuer’s other certifying officer(s) and I used to design the issuer’s ICFR is the Committee of Sponsoring Organizations of the Treadway Commission (COSO) framework.
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5.2
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ICFR – material weakness relating to design: N/A
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5.3
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Limitation on scope of design: N/A
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6.
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Reporting changes in ICFR: The issuer has disclosed in its interim MD&A any change in the issuer’s ICFR that occurred during the period beginning on July 1, 2011 and ended on September 30, 2011 that has materially affected, or is reasonably likely to materially affect, the issuer’s ICFR.
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1.
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Review: I have reviewed the interim financial report and interim MD&A (together, the “interim filings”) of Cardiome Pharma Corp. (the “issuer”) for the interim period ended September 30, 2011.
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2.
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No misrepresentations: Based on my knowledge, having exercised reasonable diligence, the interim filings do not contain any untrue statement of a material fact or omit to state a material fact required to be stated or that is necessary to make a statement not misleading in light of the circumstances under which it was made, with respect to the period covered by the interim filings.
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3.
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Fair presentation: Based on my knowledge, having exercised reasonable diligence, the interim financial report together with the other financial information included in the interim filings fairly present in all material respects the financial condition, financial performance and cash flows of the issuer, as of the date of and for the periods presented in the interim filings.
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4.
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Responsibility: The issuer’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (DC&P) and internal control over financial reporting (ICFR), as those terms are defined in National Instrument 52-109 Certification of Disclosure in Issuers’ Annual and Interim Filings, for the issuer.
|
5.
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Design: Subject to the limitations, if any, described in paragraphs 5.2 and 5.3, the issuer’s other certifying officer(s) and I have, as at the end of the period covered by the interim filings
|
|
(a)
|
designed DC&P, or caused it to be designed under our supervision, to provide reasonable assurance that
|
|
(i)
|
material information relating to the issuer is made known to us by others, particularly during the period in which the interim filings are being prepared; and
|
|
(ii)
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information required to be disclosed by the issuer in its annual filings, interim filings or other reports filed or submitted by it under securities legislation is recorded, processed, summarized and reported within the time periods specified in securities legislation; and
|
|
(b)
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designed ICFR, or caused it 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 the issuer’s GAAP.
|
5.1
|
Control framework: The control framework the issuer’s other certifying officer(s) and I used to design the issuer’s ICFR is the Committee of Sponsoring Organizations of the Treadway Commission (COSO) framework.
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5.2
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ICFR – material weakness relating to design: N/A
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5.3
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Limitation on scope of design: N/A
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6.
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Reporting changes in ICFR: The issuer has disclosed in its interim MD&A any change in the issuer’s ICFR that occurred during the period beginning on July 1, 2011 and ended on September 30, 2011 that has materially affected, or is reasonably likely to materially affect, the issuer’s ICFR.
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