0001171843-11-003333.txt : 20111104 0001171843-11-003333.hdr.sgml : 20111104 20111104151336 ACCESSION NUMBER: 0001171843-11-003333 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 7 CONFORMED PERIOD OF REPORT: 20111104 FILED AS OF DATE: 20111104 DATE AS OF CHANGE: 20111104 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Cardiome Pharma Corp CENTRAL INDEX KEY: 0001036141 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: A1 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-29338 FILM NUMBER: 111180841 BUSINESS ADDRESS: STREET 1: 6TH FLOOR STREET 2: 6190 AGRONOMY RD. CITY: VANCOUVER STATE: A1 ZIP: V6T 1Z3 BUSINESS PHONE: 1-604-677-6905 MAIL ADDRESS: STREET 1: 6TH FLOOR STREET 2: 6190 AGRONOMY RD. CITY: VANCOUVER STATE: A1 ZIP: V6T 1Z3 FORMER COMPANY: FORMER CONFORMED NAME: CARDIOME PHARMA CORP DATE OF NAME CHANGE: 20000407 6-K 1 f6k_110411.htm FORM 6-K f6k_110411.htm
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 6-K
 
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16 of
The Securities Exchange Act of 1934
 
For the month of November, 2011
 
COMMISSION FILE NO. 000-29338
 
CARDIOME PHARMA CORP.
(formerly NORTRAN PHARMACEUTICALS INC.)
 
____________________________________________
(Translation of Registrant’s name into English)
 
 
6190 Agronomy Road, 6th Floor
Vancouver, British Columbia, V6T 1Z3, CANADA
(Address of principal executive offices)
 
 
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F
 
Form 20-F [ ] Form 40-F [x]
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): [ ]
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): [ ]
 
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange act of 1934.
 
Yes [ ] No [x]
 
This Form 6-K is hereby filed and incorporated by reference in the registrant’s Registration Statements on Form F-10 (File No. 333-137935), Form F-3 (File No. 333-131912), Form S-8 (333-136696) and Form S-8 (333-125860).
 
 
 
 

 
SIGNATURES
 
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
 
 
CARDIOME PHARMA CORP.
     
     
Date: November 4, 2011
/s/ CURTIS SIKORSKY
 
Curtis Sikorsky
 
Chief Financial Officer
 




 
 

 
 
 
 

 
EXHIBIT INDEX
 
EXHIBIT
 
DESCRIPTION OF EXHIBIT
     
99.1  
Management’s Discussion and Analysis of Financial Condition and Results of Operations
     
99.2  
Consolidated Financial Statements
     
99.3
 
News Release dated November 4, 2011 - Cardiome Reports Third Quarter Results
     
99.4
 
Material Change Report dated November 4, 2011
     
99.5  
Certificate of Filing - CEO
     
99.6  
Certificate of Filing - CFO
 

 
EX-99.1 2 exh_991.htm EXHIBIT 99.1 exh_991.htm
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
 
AND RESULTS OF OPERATIONS
 

This management discussion and analysis (“MD&A”) for the nine months ended September 30, 2011 is as of November 3, 2011. We have prepared this MD&A with reference to National Instrument 51-102 “Continuous Disclosure Obligations” of the Canadian Securities Administrators.  Under the U.S./Canada Multijurisdictional Disclosure System, we are permitted to prepare this MD&A in accordance with the disclosure requirements of Canada, which are different from those of the United States. This MD&A should be read in conjunction with our interim unaudited consolidated financial statements for the three and nine months ended September 30, 2011 and our MD&A for the year ended December 31, 2010. Our consolidated financial statements are prepared in accordance with generally accepted accounting principles used in the United States of America (“U.S. GAAP”).  All amounts are expressed in U.S. dollars unless otherwise indicated.

The forward-looking statements in this discussion regarding our expectations of our future performance, liquidity and capital resources, and other non-historical statements, are based on our current expectations and beliefs, including certain factors and assumptions, as described in our most recent Annual Information Form, but are also subject to numerous risks and uncertainties, as described in the “Risk Factors” section of our Annual Information Form. As a result of these risks and uncertainties, or other unknown risks and uncertainties, our actual results may differ materially from those contained in any forward-looking statements. The words “anticipates”, “believes”, “estimates”, “expects”, “intends”, “may”, “plans”, “projects”, “will”, “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We undertake no obligation to update forward-looking statements, except as required by law. Additional information relating to Cardiome Pharma Corp., including our most recent Annual Information Form, is available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (“SEDAR”) website at www.sedar.com or the U.S. Securities and Exchange Commission’s (“SEC”) Electronic Document Gathering and Retrieval System (“EDGAR”) website at www.sec.gov/edgar.
 
OVERVIEW

We are a research-based biopharmaceutical company focused on the discovery, development and commercialization of new therapies that will improve the life and health of patients. We have one product, BRINAVESS™, approved for marketing in Europe and other territories for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults. Our lead clinical programs are also focused on the treatment of atrial fibrillation, an arrhythmia or abnormal rhythm, of the upper chambers of the heart. We have several pre-clinical projects directed at various therapeutic indications for which there is a high unmet medical need. We also have a program for GED-aPC, an engineered analog of recombinant human activated Protein C.

Vernakalant (iv)
 
Exclusive global rights to the intravenous formulation of vernakalant hydrochloride (“vernakalant (iv)”) are held by Merck & Co., Inc. directly or indirectly through an affiliate (collectively “Merck”), known as MSD outside the United States and Canada, under two separate collaborative agreements.
 
In 2003, we entered into a collaboration and license agreement for the co-development and exclusive commercialization of vernakalant (iv) in the United States, Canada and Mexico (collectively “North America”) with Astellas US LLC (“Astellas”). In July 2011, we announced that we granted consent for the transfer of rights for the development and commercialization of vernakalant (iv) in North America from Astellas to Merck.  All terms, responsibilities and payments that Astellas committed to under the original collaboration and license agreement are now assumed by Merck without change. We will continue to be responsible for 25 percent of the development costs for vernakalant (iv) in North America up to FDA approval, while Merck will be responsible for 75 percent of the development costs and all future commercialization costs for vernakalant (iv) in North America.  
 
 
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In Q2-2009, we entered into a collaboration and license agreement for the development and exclusive commercialization of vernakalant (iv) outside of North America with Merck. Under the agreement, development efforts and expenses for vernakalant (iv) outside of North America are the responsibility of Merck.

We have previously announced positive results for two pivotal Phase 3 atrial fibrillation trials, ACT 1 and ACT 3, respectively, for vernakalant (iv). We have also announced positive results from an additional Phase 3 study, ACT 2, evaluating patients with post-operative atrial arrhythmia and have completed an open-label safety study, ACT 4. In Q4-2009, we announced that the Phase 3 European Comparator Study (the “AVRO study”) was completed and met its primary endpoint of achieving statistical significance in demonstrating the superiority of vernakalant (iv) over amiodarone in the conversion of atrial fibrillation to sinus rhythm within 90 minutes of the start of drug administration.  In Q2-2010, we announced final results from the AVRO study, which showed that vernakalant (iv) was superior to amiodarone injection in converting patients’ heart rates from atrial fibrillation to sinus rhythm within 90 minutes of the start of administration.

Outside North America
 
In Q3-2010, we announced that vernakalant (iv), under the trade name BRINAVESS™, was granted marketing approval in the European Union, Iceland and Norway for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults: for non-surgery patients with atrial fibrillation of seven days duration or less and for post-cardiac surgery patients with atrial fibrillation of three days duration or less.  As a result of the European marketing approval, we received a $30 million milestone payment from Merck in Q3-2010, which was in addition to a $15 million milestone payment received from Merck in Q3-2009 when we announced that Merck had filed a Marketing Authorisation Application (“MAA”) to the European Medicines Agency seeking marketing approval for vernakalant (iv) in the European Union.

BRINAVESS™ has been commercially launched by Merck in a number of countries, and further product launches are planned for the remaining countries for which marketing approval has been obtained. We continued to earn royalty revenue from Merck for the sale of BRINAVESS™ in Europe. In the Asia-Pacific region, Merck has initiated a Phase 3 trial that is expected to support regulatory applications in additional territories for which marketing approval has not yet been attained.

North America
 
In 2006, Astellas submitted an NDA for vernakalant (iv) to the FDA seeking approval to market vernakalant (iv) in the United States for the conversion of atrial fibrillation. In Q3-2008, we announced that Astellas received an action letter from the FDA informing Astellas that the FDA had completed its review of the NDA for vernakalant (iv) and that the application was approvable.  In Q3-2009, we announced that, following extended discussions with the FDA, Astellas was undertaking a single confirmatory additional Phase 3 clinical trial under a Special Protocol Agreement (“SPA”), called ACT 5, which began patient enrolment in Q4-2009.  In Q3-2010, we announced that Astellas suspended patient enrollment in the ACT 5 trial pending FDA review of a single serious adverse event of cardiogenic shock experienced by a patient with atrial fibrillation who received vernakalant (iv). The trial’s independent Data Safety Monitoring Board reviewed the case and recommended the trial continue; however, the FDA requested that full data regarding this case from the South American clinical site be provided for their review prior to determining what steps, if any, are needed to restart the study. In July 2011, Merck acquired the rights for the development and

 
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commercialization of vernakalant (iv) in North America. We expect Merck to meet with the FDA to determine the next steps for the development of vernakalant (iv) in the United States before the end of the year.
 
Vernakalant (oral)
 
Exclusive global development and marketing rights to the oral formulation of vernakalant hydrochloride (“vernakalant (oral)”), a product candidate for the long-term prevention of atrial fibrillation recurrence, are held by Merck. We continue to assist Merck in the development of vernakalant (oral).
 
In 2006, we announced positive results from a Phase 2a pilot study.  A Phase 2b clinical study for vernakalant (oral) was initiated in Q1-2007 and we announced positive final results from the completed study in Q3-2008.  In Q2-2009, we announced a collaboration and license agreement for the development and commercialization of vernakalant (oral) providing a Merck affiliate with exclusive rights to vernakalant (oral) globally.  Further development efforts and expenses for vernakalant (oral) globally are the responsibility of Merck.  In December 2010, we announced that Merck’s current review of vernakalant (oral) was complete, and that Merck had confirmed its plans for the clinical development of vernakalant (oral) beginning in 2011. In November 2011, we announced that Merck recently completed an additional multiple rising-dose Phase 1 study to explore the safety, tolerability, pharmacokinetics and pharmacodynamics of higher doses of vernakalant (oral) than previously studied in healthy subjects and that in this study, vernakalant (oral) was well-tolerated at increased exposures. We also announced that an additional Phase 1 trial assessing the safety and tolerability of vernakalant (oral) when dosed for a more extended period of time at higher exposures is scheduled by Merck to start in late 2011. We announced that these two Phase I studies are being conducted to inform the design of a Phase II study, planned for initiation by Merck in late 2012.  
  
GED-aPC
 
In Q2-2007, we acquired exclusive worldwide rights to GED-aPC, an engineered analog of recombinant human activated Protein C, for all indications. In Q4-2007, we announced initiation of a Phase 1 study for GED-aPC.  In Q3-2009, we announced that enrolment in this trial was completed. We also announced the decision that future development and commercialization of the GED-aPC technology, currently held in a subsidiary company, will be funded either externally or via a partnership with another life sciences company. We are seeking external capital to fund future activities related to the development of GED-aPC. We may choose to co-invest in the venture to maintain an equity interest. Under a collaborative research and development agreement (“CRDA”) with the US Army Medical Research Institute of Infectious Diseases (“USAMRIID”), we supplied GED-aPC in support of a non-clinical investigation into the potential therapeutic benefit of GED-aPC in an infectious disease. The study was funded by the US Department of Defense, Defense Threat Reduction Agency and concluded in 2011. We are currently awaiting the final study report.
 
CORPORATE DEVELOPMENT

Consent to transfer North American Rights for Vernakalant (iv)
 
In July 2011, we announced that we granted consent for the transfer of rights for the development and commercialization of vernakalant (iv) in North America from Astellas to Merck.  Merck now holds exclusive global rights to vernakalant (iv) for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults. All terms, responsibilities and payments that Astellas committed to under the original collaboration and license agreement are now assumed by Merck without change.
 
 
3

 
Positive Phase 1 PK/PD Trial Results for Vernakalant (oral)
 
In November 2011, we announced that Merck recently completed an additional multiple rising-dose Phase 1 study to explore the safety, tolerability, pharmacokinetics and pharmacodynamics of higher doses of vernakalant (oral) than previously studied in healthy subjects and that in this study, vernakalant (oral) was well-tolerated at increased exposures. We also announced that an additional Phase 1 trial assessing the safety and tolerability of vernakalant (oral) when dosed for a more extended period of time at higher exposures is scheduled by Merck to start in late 2011. We announced that these two Phase I studies are being conducted to inform the design of a Phase II study, planned for initiation by Merck in late 2012.
 
CLINICAL DEVELOPMENT

The following table summarizes recent clinical trials and regulatory developments associated with each of our research and development programs:

Project
Stage of Development
Current Status
Cost to
Date (in
millions of
dollars)
Vernakalant (iv)
FDA New Drug Application (NDA)
ACT 5 trial initiated in Q4-2009. Patient enrollment currently suspended.
$  100.6
       
 
European Marketing Authorisation Application (MAA)
Marketing approval received in September 2010 under trade name BRINAVESS™.
 
       
 
European Comparator (AVRO) Study
Final results released in Q2-2010.
 
       
 
Phase 3 Asia Pacific study
Patient enrollment initiated in Q3-2010.
 
Vernakalant (oral)
Phase 2b Clinical Trial
Final results released in Q3-2008
109.5
       
 
Pharmacokinetic/ pharmacodynamics studies
Phase 1 PK/PD study completed
 
Additional Phase 1 trial to be initiated in late 2011
 
GED-aPC
Phase 1
 
Phase 1 study completed. Results to be released in 2011.
 
16.3
 
USAMRIID pre-clinical study
Awaiting final study report
 
Current Pre-clinical Projects
Pre-Clinical Stage
Pre-clinical studies
10.6
 
 
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The following provides a description of our clinical development efforts for each of our projects during the quarter:

Vernakalant (iv)
 
Prior to the transfer of rights in July 2011, for the development and commercialization of vernakalant (iv) in North America from Astellas to Merck, we continued to support Astellas with the development of vernakalant (iv) in North America, including the ongoing ACT 5 trial, for which patient enrolment is currently suspended. Subsequent to the transfer of rights for the development and commercialization of vernakalant (iv) in North America, we now support Merck in the development of vernakalant (iv) globally.    

Vernakalant (oral)
 
During Q3-2011, we continued to support Merck in the development of vernakalant (oral). Further development efforts for vernakalant (oral) globally are the responsibility of Merck.

GED-aPC
 
Under a CRDA with USAMRIID, we supplied GED-aPC in support of a non-clinical investigation into the potential therapeutic benefit of GED-aPC in an infectious disease. The study was funded by the US Department of Defense, Defense Threat Reduction Agency and concluded in 2011. We are currently awaiting the final study report. We are also waiting to see if additional grants or funding will be made available from similar US government or other sources.

Other Projects
 
We continue to conduct pre-clinical research and development work on our internal early stage assets. Our internal technology focus is on modulating cellular proteins (ion channels) that gate the movement of ions across the cell membrane to control a variety of essential functions ranging from the contraction of muscles, to the secretion from glands, and even responses to foreign bodies and inflammation.  The wide variety of such proteins provides a broad area for the development of therapeutics useful in a large number of human disorders.

We continue to review the external world for later stage assets which could mainly leverage off our current expertise in ion-channel modulation or in diseases associated with ion-channel dysfunction.  We do not expect that any considered transaction would have a major impact on our capital structure or operational costs.
 
INTERNAL CONTROLS OVER FINANCIAL REPORTING

There were no changes in our internal controls over financial reporting that occurred during the nine months ended September 30, 2011 that have materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting.
 
CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT ESTIMATES

Our interim consolidated financial statements are prepared in accordance with U.S. GAAP. These accounting principles require us to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial

 
5

 
statements as well as the reported amounts of revenues and expenses during the reporting periods. We believe that the estimates and assumptions upon which we rely are reasonable based upon information available at the time that these estimates and assumptions were made. Actual results may differ from these estimates under different assumptions or conditions. Significant areas requiring management estimates include the assessment of net recoverable value and amortization period of intangible assets, clinical trial accounting, revenue recognition, stock-based compensation expense, and estimation of income tax.
 
There were no material changes to our critical accounting estimates during the nine months ended September 30, 2011, from those disclosed in the MD&A for the year ended December 31, 2010.

The significant accounting policies that we believe are the most critical in fully understanding and evaluating our reported financial results include revenue recognition and clinical trial accounting.  These and other significant accounting policies are described more fully in Notes 3 and 20 of our annual consolidated financial statements for the year ended December 31, 2010. There have been no changes in these accounting policies during the nine months ended September 30, 2011, except as described below.

Changes in Significant Accounting Policies

Multiple-Deliverable Revenue Arrangements:
 
On January 1, 2011, we prospectively adopted amendments issued by the Financial Accounting Standards Board (“FASB”) associated with multiple-deliverable revenue arrangements. These amendments (a) provide principles and application guidance on whether multiple deliverables exist, how the arrangement should be separated, and the consideration allocated; (b) require an entity to allocate revenue in an arrangement using estimated selling prices of deliverables if a vendor does not have vendor-specific objective evidence or third-party evidence of selling price; (c) eliminate the use of the residual method and require an entity to allocate the revenue using the relative selling price method; and (d) significantly expand related disclosure requirements. The adoption of the amendments did not have a material impact on our consolidated financial position, results of operations or cash flows for the periods presented.

Milestone method of revenue recognition:
 
On January 1, 2011, we prospectively adopted guidance issued by the FASB on the milestone method of revenue recognition for research and development transactions. This method relates to consideration that is contingent upon achievement of a milestone such as the payments provided for under our collaboration and license agreements. We determine the revenue recognition of contingent milestones at the inception of a collaboration and license agreement. Payments are recognized in their entirety in the period earned for substantive milestones for which the consideration (a) is commensurate with our performance to achieve the milestone or enhance the value of the delivered item, (b) relates to past performance and (c) is reasonable relative to the deliverables and payment terms within the agreement. We have determined all our milestones under our current collaboration and license agreements to be substantive. There have been no milestones recognized since adoption. The adoption of the guidance did not have a material impact on the timing or pattern of revenue recognition relative to our collaboration and license agreements nor is expected to in future periods.

 
 
6

 
Impact of Accounting Pronouncements Affecting Future Periods

Fair Value Measurements:
 
In May 2011, the FASB provided amendments to achieve common fair value measurement and disclosure requirements in U.S. GAAP and International Financial Reporting Standards. The amendments provide clarification and/or additional requirements relating to the following: a) application of the highest and best use and valuation premise concepts, b) measurement of the fair value of instruments classified in an entity’s shareholders’ equity, c) measurement of the fair value of financial instruments that are managed within a portfolio, d) application of premiums and discounts in a fair value measurement, and e) disclosures about fair value measurements. These amendments will be effective prospectively for interim and annual periods beginning after December 15, 2011. We do not expect the adoption of the amendments to have a material impact on our financial position, results of operations or cash flows.

Comprehensive Income:
 
In June 2011, the FASB provided amendments requiring an entity to present the total of comprehensive income, the components of net income, and the components of other comprehensive income either in a single continuous statement of comprehensive income or in two separate but consecutive statements, eliminating the option to present the components of other comprehensive income as part of the statement of changes in stockholders’ equity. Additionally, the amendments require an entity to present reclassification adjustments on the face of the financial statements from other comprehensive income to net income. These amendments will be effective retrospectively for fiscal years, and interim periods within those years, beginning after December 15, 2011. We do not expect the adoption of the amendments to have a material impact on our financial position, results of operations or cash flows.
 
RESULTS OF OPERATIONS

We recorded a net loss of $7.2 million ($0.12 loss per share) for the three months ended September 30, 2011 (Q3-2011), compared to net income of $22.8 million ($0.37 basic and diluted income per share) for the three months ended September 30, 2010 (Q3-2010). On a year-to-date basis, we recorded a net loss of $22.0 million ($0.36 loss per share) for the nine months ended September 30, 2011, compared to net income of $42.8 million ($0.70 basic and diluted income per share) for the nine months ended September 30, 2010. The net loss for Q3-2011 and year-to-date was largely due to expenditures incurred on our ongoing research and development programs, as well as normal operating costs. The net income for the three and nine months ended September 30, 2010, was largely due to recognition of the $30 million milestone payment from Merck related to the marketing approval in Europe of vernakalant (iv) in Q3-2010 that exceeded ongoing research and development expenditures and normal operating costs. During the nine months ended September 30, 2010, we also recognized revenue from Merck related to payments received in 2009 pursuant to the collaboration and license agreement. These amounts were fully recognized in 2010.

Revenues
 
Revenue for Q3-2011 was $0.3 million, a decrease of $29.9 million from $30.2 million in Q3-2010. On a year-to-date basis, revenue for the nine months ended September 30, 2011 and 2010 was $1.1 million and $65.7 million, respectively. Revenue comprised of licensing and other fees and research collaborative fees we received from our collaborative partners.

 
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Licensing and other fees represent recognition of revenue related to upfront payments, milestone payments and royalties from our collaborative partners, as well as proceeds from shipment of clinical supplies to Merck. Licensing and other fees for the three and nine months ended September 30, 2011 were not significant, compared to $30.0 million and $65.1 million for the three and nine months ended September 30, 2010. The licensing and other fees recognized in 2010 were primarily attributable to the $30 million milestone payment from Merck related to the marketing approval in Europe of vernakalant (iv) in Q3-2010 and recognition of payments received from Merck in 2009. Licensing and other fees are not expected to be significant for the remainder of the year.

Research collaborative fees comprise contract research fees and project management fees from our collaborative partners. We recorded research collaborative fees of $0.2 million in Q3-2011 and Q3-2010. On a year-to-date basis, we recorded research and collaborative fees of $0.7 million and $0.5 million for the nine months ended September 30, 2011 and 2010, respectively. Research collaborative fees are not expected to be significant for the remainder of the year.

In fiscal 2010, we also started earning royalty revenue from Merck for the sale of BRINAVESS™ in Europe. Royalty revenue received from Merck has not been significant to date. Although, we are likely to receive increased royalty revenue as BRINAVESS™ gains market acceptance and is launched in additional countries throughout Europe, we do not expect the royalty revenue in the remainder of 2011 to be significant.

In the future, we may earn additional revenue from our collaboration and licensing agreements with Merck for the development and commercialization of vernakalant (iv) and vernakalant (oral).
 
Research and Development Expenditures
(in thousands of dollars)
For the Three Months
Ended September 30
For the Nine Months
Ended September 30
 
Project
2011
$
2010
 $
2011
$  
2010
$
Vernakalant (oral)
198
451
925
1,099
Vernakalant (iv)
974
2,461
4,217
6,566
GED-aPC
26
43
285
713
Other projects
2,705
531
6,355
2,544
Total research and development expenses
3,903
3,486
11,782
10,922

Research and development (“R&D”) expenditures were $3.9 million for Q3-2011 and $3.5 million for Q3-2010. We incurred total R&D expenditures of $11.8 million for the nine months ended September 30, 2011, compared to $10.9 million for the same period in fiscal 2010. For the three and nine months ended September 30, 2011, we continued to incur costs related to the ACT 5 trial for vernakalant (iv) to follow up with existing patients as well as monitor and analyze the data collected. Expenditures related to our vernakalant (oral) and GED-aPC programs remain at a minimal level. We increased our spending on other projects related to internal preclinical research and development work.

For the remainder of fiscal 2011, we may continue to incur costs related to the development of vernakalant (iv) in the North American market and we will continue to incur costs related to the continued development of other pre-clinical and early stage research projects.

 
8

 
General and Administration Expenditures
 
G&A expenditures primarily consist of wages and benefits (including stock-based compensation), office costs, corporate costs, business development costs, consulting fees and professional fees.
 
General and administration (“G&A”) expenditures for Q3-2011 were $2.7 million as compared to $3.5 million for Q3-2010. The decrease in G&A expenditures related primarily to a decrease in consulting fees related to business development activities. On a year-to-date basis, we incurred total G&A expenditures of $9.4 million for the nine months ended September 30, 2011, compared to $10.1 million for the same period in 2010. The decrease in G&A expenditures on a year-to-date basis related primarily to a decrease in stock-based compensation expense and consulting fees. We expect our G&A expenditures to remain at current levels for the remainder of the current fiscal year.

Other Income and Expense
 
Other income and expense consists primarily of interest expense on our $25 million advance from Merck, sublease income, as well as foreign exchange gains (losses) attributable to the translation of foreign currency denominated net monetary assets into our functional currency at period end.
 
Other expense for Q3-2011 and Q3-2010 was $0.5 million and $0.2 million, respectively. For the nine months ended September 30, 2011 and 2010, other expense was $1.1 million and $0.9 million, respectively.



 
9

 
QUARTERLY FINANCIAL INFORMATION

The following table summarizes selected unaudited consolidated financial data for each of the last eight quarters:

   
Quarter ended
 
(In thousands of dollars
except per share amounts)
 
September
30, 2011
   
June 30,
2011
   
March 31,
2011
   
December 31,
2010
 
                         
Total revenue
  $ 274     $ 443     $ 387     $ 374  
Research and development
    3,903       4,073       3,806       4,417  
General and administration
    2,764       3,466       3,224       2,740  
Net income (loss)
  $ (7,153 )   $ (7,723 )   $ (7,146 )   $ (7,302 )
Net income (loss) per share
                               
Basic and diluted
  $ (0.12 )   $ (0.13 )   $ (0.12 )   $ (0.12 )
                                 
(In thousands of dollars
except per share amounts)
 
Quarter ended
 
 
September 30,
2010
   
June 30,
2010
   
March 31,
2010
   
December 31,
2009
(Adjusted)(1)
 
                                 
Total revenue
  $ 30,221     $ 12,424     $ 23,045     $ 23,438  
Research and development
    3,486       3,682       3,754       5,788  
General and administration
    3,505       3,272       3,358       3,367  
Net income (loss)
  $ 22,768     $ 4,560     $ 15,473     $ 12,102  
Net Income (loss) per share
                               
Basic
  $ 0.37     $ 0.08     $ 0.26     $ 0.20  
Diluted
    0.37       0.07       0.26       0.20  
 
 (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.

Variations in our revenue, expenses and net income (loss) for the periods above resulted primarily from the following factors:

Licensing and other fees:
 
The timing of payments and achievement of milestones under our collaboration and license agreements resulted in the variations in revenue. Revenue earned from Q4-2009 to Q2-2010, related to a $60.0 million upfront payment, MAA milestone payment and proceeds from shipment of clinical supplies under the collaboration and license agreement with Merck. Revenue for Q3-2010 was mainly due to a $30.0 million milestone payment from Merck relating to the marketing approval in Europe of vernakalant (iv).

Research and Development Expenses:
 
The timing of clinical trials and research work performed resulted in the variations in R&D expenses. The AVRO Phase 3 comparator study for vernakalant (iv) completed in Q4-2009.

 
10

 
General and Administration Expenses:
 
Business development activities, strategic initiatives taken and the timing of stock based compensation expense resulted in the variations in G&A expenses.

Foreign Exchange:
 
Prior to 2010, translation of our U.S. dollar net monetary assets into Canadian dollars for reporting purposes at period end resulted in variations in net income (loss).
 
LIQUIDITY AND CAPITAL RESOURCES

Our operational activities during Q3-2011 were financed mainly by working capital carried forward from the preceding fiscal year. We believe that our cash position as at September 30, 2011, the anticipated cash inflows from our collaborative partner, and available credit facility will be sufficient to finance our operational and capital needs for at least 24 months. Our future cash requirements may vary materially from those now expected due to a number of factors, including the costs associated with clinical trials, fees from collaborative and license arrangements with third parties and from strategic opportunities.

At September 30, 2011, we had working capital of $52.6 million compared to $72.7 million at December 31, 2010. The decrease in working capital of $20.1 million is mainly due to funding of our support for Merck, current exploratory research and development projects and general and administrative costs. We had available cash reserves comprised of cash and cash equivalents of $54.5 million at September 30, 2011 compared to $76.9 million at December 31, 2010.

Sources and Uses of Cash
(in thousands of dollars)
 
For the Three Months Ended
September 30,
   
For the Nine Month
Ended September 30,
 
   
2011
   
2010
   
2011
   
2010
 
Cash used in operating activities
  $ (6,402 )   $ (5,009 )   $ (21,702 )   $ (20,698 )
Cash used in investing activities
    (158 )     (151 )     (943 )     (458 )
Cash provided by financing activities
    -       715       358       27,359  
Effect of foreign exchange rate on cash
     and cash equivalents
    (209 )     170       (54 )     (41 )
Net increase (decrease) in cash and cash
equivalents
  $ (6,769 )   $ (4,275 )   $ (22,341 )   $ 6,162  

Cash used in operating activities for Q3-2011 was $6.4 million, an increase of $1.4 million from $5.0 million in Q3-2010 primarily due to increased spending on projects related to internal preclinical research and development work. Cash used in operating activities for the nine months ended September 30, 2011 was $21.7 million, an increase of $1.0 million from $20.7 million used in operating activities for the same period in 2010.

Cash used in investing activities in Q3-2011 and Q3-2010 was $0.2 million, and was $0.9 million and $0.5 million for the nine months ended September 30, 2011 and 2010 respectively. Cash used in investing activities related to the purchase of capital assets and costs incurred related to patents.

 
11

 
Cash provided by financing activities in Q3-2011 was insignificant as compared to $0.7 million in Q3-2010, which related to exercise of stock options. On a year-to-date basis, cash provided by financing activities for the nine months ended September 30, 2011 was $0.4 million, which related to exercise of stock options and $27.4 million for the same period in fiscal 2010. Cash provided by financing activities in the nine months ended September 30, 2010, related to the exercise of stock options and to the drawdown of $25 million of secured, interest bearing long-term debt pursuant to the credit facility which is part of our collaboration and license agreement with Merck. We may, at our option, repay all or a portion of the advance from time to time without premium or penalty. This advance must be repaid in full by December 31, 2016.

Contractual Obligations
 
As of September 30, 2011 and in the normal course of business we have the following obligations to make future payments, representing contracts and other commitments that are known and committed.

Contractual Obligations
 
Payment due by period
 
(In thousands of dollars)
 
2011
   
2012
   
2013
   
2014
   
2015
   
There-
after
   
Total
 
Long-term debt and interest
     expense
  $ 562     $ 2,230     $ 2,230     $ 2,230     $ 2,230     $ 27,230 (1)   $ 36,712  
Operating lease obligations
    404       1,637       1,643       1,257       1,185       6,434       12,560  
Commitments for clinical
     research agreements and
     other agreements
    212       68       3       2    
Nil
   
Nil
      285  
Other long-term obligations
    7       30       34       6    
Nil
   
Nil
      77  
Total
  $ 1,185     $ 3,965     $ 3,910     $ 3,495     $ 3,415     $ 33,664     $ 49,634  
 
(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.

Outstanding Share Capital
 
As of November 3, 2011, there were 61,129,091 common shares issued and outstanding, and 4,941,990 common shares issuable upon the exercise of outstanding stock options (of which 3,505,491 were exercisable) at a weighted average exercise price of CAD $7.06 per share.
 
RELATED PARTY TRANSACTIONS

Included in accounts payable and accrued liabilities as of September 30, 2011 was $0.2 million (December 31, 2010 - $0.1 million) owing to a legal firm where our corporate secretary is a partner. The amounts charged were recorded at their exchange amounts and are subject to normal trade terms. We incurred approximately $0.6 million for the nine months ended September 30, 2011 (2010 - $0.4 million) of legal fees for services provided by this legal firm.
 
OFF-BALANCE SHEET ARRANGEMENTS

We have no material undisclosed off-balance sheet arrangements that have or are reasonably likely to have, a current or future effect on our results of operations, financial condition, changes in financial condition, revenues or expenses, liquidity, capital expenditures or capital resources that is material to investors.
 
 
12

 
FINANCIAL INSTRUMENTS AND RISKS

We are exposed to credit risks and market risks related to changes in interest rates and foreign currency exchange rates, each of which could affect the value of our current assets and liabilities. We invest our cash reserves in fixed rate, highly liquid and highly rated financial instruments such as treasury bills, commercial papers and banker’s acceptances. At September 30, 2011, our cash and cash equivalents were primarily cash. We do not believe that the results of operations or cash flows would be affected to any significant degree by a sudden change in market interest rates relative to our investment portfolio, due to the relative short-term nature of the investments and our current ability to hold fixed income investments to maturity. We have not entered into any forward currency contracts or other financial derivatives to hedge foreign exchange risk. We are subject to foreign exchange rate fluctuations that could have a material effect on our future operating results or cash flows. We are also subject to interest rate fluctuations on our line of credit from Merck.

 
 
 
 
 
13

EX-99.2 3 exh_992.htm EXHIBIT 99.2 exh_992.htm
 
 
Consolidated Financial Statements
(Expressed in thousands of United States (U.S.) dollars)
(Prepared in accordance with generally accepted accounting principles used in the United States of America (U.S. GAAP))


CARDIOME PHARMA CORP.


 
Periods ended September 30, 2011 and 2010
(Unaudited)
 
 
 
 

 

 
 

 
 
CARDIOME PHARMA CORP.
 
Consolidated Balance Sheets
 
(Unaudited)
 
(Expressed in thousands of U.S. dollars, except share amounts)
 
(Prepared in accordance with U.S. GAAP)

   
September 30,
 
December 31,
   
2011
 
2010
Assets
               
Current assets:
               
Cash and cash equivalents
 
$
54,547
   
$
76,888
 
Accounts receivable
   
606
     
732
 
Prepaid expenses and other assets
   
681
     
1,000
 
     
55,834
     
78,620
 
Property and equipment
   
2,121
     
2,069
 
Intangible assets
   
1,690
     
1,635
 
   
$
59,645
   
$
82,324
 
Liabilities and Stockholders’ Equity
               
Current liabilities:
               
Accounts payable and accrued liabilities (note 5)
 
$
3,148
   
$
5,705
 
Current portion of deferred leasehold inducement
   
114
     
216
 
     
3,262
     
5,921
 
Deferred leasehold inducement
   
473
     
486
 
Long-term debt
   
25,000
     
25,000
 
     
28,735
     
31,407
 
Stockholders’ equity:
               
Common stock
               
Authorized - unlimited number with no par value
               
Issued and outstanding – 61,129,091 (2010 - 61,052,362)
   
262,097
     
261,554
 
Additional paid-in capital
   
31,934
     
30,462
 
Deficit
   
(281,306
)
   
(259,284
)
Accumulated other comprehensive income
   
18,185
     
18,185
 
     
30,910
     
50,917
 
   
$
59,645
   
$
82,324
 
 
Contingencies (note 9)
 
Related party transactions (note 8)
 
See accompanying notes to the consolidated financial statements.

 
 

 
 
CARDIOME PHARMA CORP.
 
Consolidated Statements of Operations and Comprehensive Income (Loss)
 
(Unaudited)
 
(Expressed in thousands of U.S. dollars, except share and per share amounts)
 
(Prepared in accordance with U.S. GAAP)
 
   
Three months ended
   
Nine months ended
 
   
September 30,
2011
   
September 30,
2010
   
September 30,
2011
   
September 30,
2010
 
Revenue:
                       
Licensing and other fees
  $ 91     $ 30,000     $ 372     $ 65,146  
Research collaborative fees
    183       221       732       544  
      274       30,221       1,104       65,690  
Expenses:
                               
Research and development
    3,903       3,486       11,782       10,922  
General and administration
    2,764       3,505       9,454       10,135  
Amortization
    271       291       825       890  
      6,938       7,282       22,061       21,947  
Operating income (loss)
    (6,664 )     22,939       (20,957 )     43,743  
                                 
Other expenses (income):
                               
Interest expense
    560       565       1,659       1,412  
Other income
    (234 )     (187 )     (626 )     (534 )
Foreign exchange loss (gain)
    163       (207 )     32       64  
      489       171       1,065       942  
Net income (loss) and comprehensive income (loss) for the period
  $ (7,153 )   $ 22,768     $ (22,022 )   $ 42,801  
Income (loss) per common share (note 6)
                               
Basic and Diluted
  $ (0.12 )   $ 0.37     $ (0.36 )   $ 0.70  
Weighted average common shares outstanding during the period
                               
Basic
    61,129,091       60,985,176       61,124,696       60,733,543  
Diluted
    61,129,091       61,740,580       61,124,696       61,343,530  
                                 
 
See accompanying notes to the consolidated financial statements.
 
 
 

 
 
CARDIOME PHARMA CORP.
 
Consolidated Statements of Stockholders’ Equity
 
For the nine months ended September 30, 2011 and 2010
 
(Unaudited)
 
(Expressed in thousands of U.S. dollars)
 
(Prepared in accordance with U.S. GAAP)

For the nine months ended September 30, 2011
 
Common
stock
   
Additional
paid-in capital
   
Deficit
   
Accumulated
other
comprehensive
income
   
Total
stockholders’
equity
 
Balance at December 31, 2010
  $ 261,554     $ 30,462     $ (259,284 )   $ 18,185     $ 50,917  
Net loss
    -       -       (22,022 )     -       (22,022 )
Common stock issued upon exercise of options
    358       -       -       -       358  
Reallocation of additional paid-in capital arising from stock-based compensation related to exercise of options
    185       (185 )     -       -       -  
Stock option expense recognized
    -       1,657       -       -       1,657  
Balance at September 30, 2011
  $ 262,097     $ 31,934     $ (281,306 )   $ 18,185     $ 30,910  
                                         
 
 
For the nine months ended September 30, 2010
 
Common
stock
   
Additional
paid-in capital
   
Deficit
   
Accumulated
other
comprehensive
income
   
Total
stockholders’
equity
 
Balance at December 31, 2009
  $ 256,711     $ 29,669     $ (294,783 )   $ 18,185     $ 9,782  
Net income
    -       -       42,801       -       42,801  
Common stock issued upon exercise of options
    2,359       -       -       -       2,359  
Reallocation of additional paid-in capital arising from stock-based compensation related to exercise of options
    2,475       (2,475 )     -       -       -  
Stock option expense recognized
    -       2,477       -       -       2,477  
Balance at September 30, 2010
  $ 261,545     $ 29,671     $ (251,982 )   $ 18,185     $ 57,419  
 
See accompanying notes to the consolidated financial statements.
 
 
 

 
 
CARDIOME PHARMA CORP.
 
Consolidated Statements of Cash Flows
 
(Unaudited)
 
(Expressed in thousands of U.S. dollars)
 
(Prepared in accordance with U.S. GAAP)
 
   
Three months ended
   
Nine months ended
 
   
September 30,
2011
   
September 30,
2010
   
September 30,
2011
   
September 30,
2010
 
Cash flows from operating activities:
                       
Net income (loss) for the period
  $ (7,153 )   $ 22,768     $ (22,022 )   $ 42,801  
Add items not affecting cash:
                               
Amortization
    271       291       825       890  
Stock-based compensation
    636       551       1,657       2,477  
Deferred leasehold inducement
    (44 )     (50 )     (115 )     (156 )
Unrealized foreign exchange gain
    80       (119 )     (21 )     (23 )
Changes in operating assets and liabilities:
                               
Accounts receivable
    642       (29,502 )     128       (29,196 )
Prepaid expenses and other assets
    (150 )     (28 )     319       (234 )
Accounts payable and accrued liabilities
    (684 )     1,080       (2,473 )     (2,060 )
Deferred revenue
    -       -       -       (35,197 )
Net cash used in operating activities
    (6,402 )     (5,009 )     (21,702 )     (20,698 )
                                 
Cash flows from investing activities:
                               
Purchase of property and equipment
    (101 )     (73 )     (634 )     (216 )
Purchase of intangible assets
    (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
    -       -       -       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:
                               
Interest paid
  $ 567     $ 573     $ 1,677     $ 1,423  
Interest received
    7       6       18       10  
 
See accompanying notes to the consolidated financial statements.
 
 
 

 
 
CARDIOME PHARMA CORP.
 
Notes to Consolidated Financial Statements
 
(Unaudited)
(Expressed in thousands of U.S. dollars except share and per share amounts and where otherwise indicated)
(Prepared in accordance with U.S. GAAP)
As at and for the three and nine months ended September 30, 2011 and 2010


1.Basis of presentation:
 
These unaudited interim consolidated financial statements have been prepared by management in accordance with generally accepted accounting principles used in the United States of America (U.S. GAAP) and are presented in U.S. dollars. They include all adjustments consisting solely of normal, reoccurring adjustments necessary for fair presentation of the periods presented. These unaudited interim consolidated financial statements do not include all note disclosures required by U.S. GAAP on an annual basis, and therefore should be read in conjunction with the annual audited consolidated financial statements for the year ended December 31, 2010 filed with the appropriate securities commissions. The results of operations for the three and nine month periods ended September 30, 2011 and 2010 are not necessarily indicative of the results for the full year.
 
The Company has financed its cash requirements primarily from share issuances, payments from research collaborators, licensing fees and draws from a credit facility available under the Company’s collaborative agreement. The Company’s ability to realize the carrying value of its assets is dependent on successfully bringing its technologies to market and achieving future profitable operations, the outcome of which cannot be predicted at this time.
 
2.Changes in significant accounting policies:
 
(a)  Multiple-Deliverable Revenue Arrangements:
 
On January 1, 2011, the Company prospectively adopted amendments issued by the Financial Accounting Standards Board (“FASB”) associated with multiple-deliverable revenue arrangements. These amendments (a) provide principles and application guidance on whether multiple deliverables exist, how the arrangement should be separated, and the consideration allocated; (b) require an entity to allocate revenue in an arrangement using estimated selling prices of deliverables if a vendor does not have vendor-specific objective evidence or third-party evidence of selling price; (c) eliminate the use of the residual method and require an entity to allocate the revenue using the relative selling price method; and (d) significantly expand related disclosure requirements. The adoption of the amendments did not have a material impact on the Company’s consolidated financial position, results of operations or cash flows for the periods presented.
 
(b)  Milestone method of revenue recognition:
 
On January 1, 2011, the Company prospectively adopted guidance issued by the FASB on the milestone method of revenue recognition for research and development transactions. This method relates to consideration that is contingent upon achievement of a milestone such as the payments provided for under the Company’s collaboration and license agreements. The Company determines the revenue recognition of contingent milestones at the inception of a collaboration and license agreement.  Payments are recognized in their entirety in the period earned for substantive milestones for which the consideration (a) is commensurate

 
2

 
 
CARDIOME PHARMA CORP.
 
Notes to Consolidated Financial Statements
 
(Unaudited)
(Expressed in thousands of U.S. dollars except share and per share amounts and where otherwise indicated)
(Prepared in accordance with U.S. GAAP)
As at and for the three and nine months ended September 30, 2011 and 2010



2.Changes in significant accounting policies (continued):
 
(b)  Milestone method of revenue recognition (continued):
 
with the Company’s performance to achieve the milestone or enhance the value of the delivered item, (b) relates to past performance and (c) is reasonable relative to the deliverables and payment terms within the agreement. The Company has determined all milestones under current collaboration and license agreements to be substantive. There have been no milestones recognized since adoption. The adoption of the guidance did not have a material impact on the timing or pattern of revenue recognition relative to the Company’s collaboration and license agreements nor is expected to in future periods.
 
3.Future changes in accounting policies:

(a)  
Fair Value Measurements:
 
In May 2011, the FASB provided amendments to achieve common fair value measurement and disclosure requirements in U.S. GAAP and International Financial Reporting Standards. The amendments provide clarification and/or additional requirements relating to the following: a) application of the highest and best use and valuation premise concepts, b) measurement of the fair value of instruments classified in an entity’s shareholders’ equity, c) measurement of the fair value of financial instruments that are managed within a portfolio, d) application of premiums and discounts in a fair value measurement, and e) disclosures about fair value measurements. These amendments will be effective prospectively for interim and annual periods beginning after December 15, 2011. We do not expect the adoption of the amendments to have a material impact on the Company’s financial position, results of operations or cash flows.
 
(b)  
Comprehensive Income:
 
In June 2011, the FASB provided amendments requiring an entity to present the total of comprehensive income, the components of net income, and the components of other comprehensive income either in a single continuous statement of comprehensive income or in two separate but consecutive statements, eliminating the option to present the components of other comprehensive income as part of the statement of changes in stockholders’ equity. Additionally, the amendments require an entity to present reclassification adjustments on the face of the financial statements from other comprehensive income to net income. These amendments will be effective retrospectively for fiscal years, and interim periods within those years, beginning after December 15, 2011. We do not expect the adoption of the amendments to have a material impact on the Company’s financial position, results of operations or cash flows.
 
 
3

 
 
CARDIOME PHARMA CORP.
 
Notes to Consolidated Financial Statements
 
(Unaudited)
(Expressed in thousands of U.S. dollars except share and per share amounts and where otherwise indicated)
(Prepared in accordance with U.S. GAAP)
As at and for the three and nine months ended September 30, 2011 and 2010



4.      Financial instruments:
 
The Company’s financial instruments consist of cash and cash equivalents, accounts receivable, accounts payable and accrued liabilities and long term debt. The fair values of accounts receivable, accounts payable and accrued liabilities approximate carrying values because of their short-term nature.
 
As of September 30, 2011, the carrying value of the Company’s long-term debt approximates its fair value based on current market borrowing rates. The long-term debt is classified as Level 2 in the fair value hierarchy.
 
5.      Accounts payable and accrued liabilities:
 
Accounts payable and accrued liabilities comprise of:
 
             
   
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)
    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).
 
6.Basic and diluted income (loss) per share:
 
As the Company incurred a loss for the three and nine months ended September 30, 2011, all stock options were anti-dilutive and were excluded from the diluted weighted average shares outstanding for that period (three and nine months ended September 30, 2010 – 2,929,596 and 3,594,193 options were anti-dilutive, respectively).

 
4

 
 
CARDIOME PHARMA CORP.
 
Notes to Consolidated Financial Statements
 
(Unaudited)
(Expressed in thousands of U.S. dollars except share and per share amounts and where otherwise indicated)
(Prepared in accordance with U.S. GAAP)
As at and for the three and nine months ended September 30, 2011 and 2010



6.Basic and diluted income (loss) per share (continued):
 
Reconciliations of the income (loss) and weighted average number of common shares used in the basic and diluted calculations are set forth below:

   
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  
 
7.      Collaborative agreements:
 
On July 26, 2011, the Company granted consent for the transfer of rights for the development and commercialization of vernakalant (iv) in Canada, Mexico and the United States (collectively “North America”), from Astellas US LLC ("Astellas") to Merck & Co., Inc. (“Merck”).  Merck now holds exclusive global rights to vernakalant (iv) for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults. All terms, responsibilities and payments that Astellas committed to under the original collaboration and license agreement are now assumed by Merck without change. The Company will continue to be responsible for 25 percent of the development costs for vernakalant (iv) in North America, while Merck will be responsible for 75 percent of development costs and all future commercialization costs for vernakalant (iv) in North America.  

8.      Related party transactions:
 
The Company has incurred expenses for services provided by a law firm in which an officer of the Company is a partner. The amounts charged are recorded at their exchange amounts and are subject to normal trade terms. For the nine months ended September 30, 2011, the Company has incurred legal fees of $619 (September 30, 2010 - $448) for services provided by the law firm relating to general corporate matters. Included in accounts payable and accrued liabilities at September 30, 2011 is an amount of $210 (December 31, 2010 - $146) owing to the legal firm.
 
 
5

 
 
CARDIOME PHARMA CORP.
 
Notes to Consolidated Financial Statements
 
(Unaudited)
(Expressed in thousands of U.S. dollars except share and per share amounts and where otherwise indicated)
(Prepared in accordance with U.S. GAAP)
As at and for the three and nine months ended September 30, 2011 and 2010



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.

 
6

 
EX-99.3 4 exh_993.htm EXHIBIT 99.3 Cardiome Reports Third Quarter Results

EXHIBIT 99.3

Cardiome Reports Third Quarter Results

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
EX-99.4 5 exh_994.htm EXHIBIT 99.4 exh_994.htm
FORM 51-102F3

MATERIAL CHANGE REPORT


1.  
Name and Address of Company
Cardiome Pharma Corp.
6190 Agronomy Rd, 6th Floor
Vancouver, BC V6T 1Z3

2.  
Date of Material Change
November 4, 2011

3.  
News Release
November 4, 2011 - Vancouver, Canada

4.  
Summary of Material Change
Cardiome Pharma Corp. 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).

5.  
Full Description of Material Change
See attached press release

6.  
Reliance on Subsection 7.1(2) or (3) of National Instrument 51-102
Not Applicable.

7.  
Omitted Information
Not Applicable.

8.  
Executive Officer
 
Name:
Title:
Phone No.:
Curtis Sikorsky
Chief Financial Officer
604-677-6905

9.  
Date of Report
November 4, 2011
 
  Per:
Curtis Sikorsky”
   
Curtis Sikorsky,
Chief Financial Officer
     
 
 
EX-99.5 6 exh_995.htm EXHIBIT 99.5 exh_995.htm
Form 52-109F2
Certification of interim filings - full certificate

I, Douglas Janzen, President and Chief Executive Officer of Cardiome Pharma Corp., certify the following:
 
1.
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.

2.
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.

3. 
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.

4. 
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. 
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)
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)
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.

5.2
ICFR – material weakness relating to design: N/A

5.3
Limitation on scope of design:  N/A
 
6.
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.


Date: November 4, 2011

“Doug Janzen”
Douglas Janzen
President and Chief Executive Officer

EX-99.6 7 exh_996.htm EXHIBIT 99.6 exh_996.htm
Form 52-109F2
Certification of interim filings - full certificate

I, Curtis Sikorsky, Chief Financial Officer of Cardiome Pharma Corp., certify the following:
 
1.
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.

2.
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.

3. 
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.

4. 
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. 
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)
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)
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.

5.2
ICFR – material weakness relating to design: N/A

5.3
Limitation on scope of design:  N/A

6.
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.


Date: November 4, 2011

“Curtis Sikorsky”
Curtis Sikorsky
Chief Financial Officer