0001171843-12-003004.txt : 20120808 0001171843-12-003004.hdr.sgml : 20120808 20120808152945 ACCESSION NUMBER: 0001171843-12-003004 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 6 CONFORMED PERIOD OF REPORT: 20120630 FILED AS OF DATE: 20120808 DATE AS OF CHANGE: 20120808 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: 121016721 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_080812.htm FORM 6-K f6k_080812.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 August, 2012
 
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: August 8, 2012
/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
 
Material Change Report dated August 8, 2012
     
99.4  
Certificate of Filing - CEO
     
99.5  
Certificate of Filing - CFO
 

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

This management discussion and analysis (“MD&A”) for the six months ended June 30, 2012 is as of August 7, 2012. 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 six months ended June 30, 2012 and our MD&A for the year ended December 31, 2011. 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 life sciences company focused on the discovery, development and commercialization of new therapies that will improve the life and health of patients. Our lead clinical program is 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 have one product, BRINAVESSTM, approved for marketing in Europe and other territories for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults.

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.  
 
 
1

 
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 Q2-2010, we announced final results from the Phase 3 European Comparator Study (the “AVRO study”) which showed 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.  

Outside North America
 
In Q3-2009, we received a $15 million milestone payment from Merck upon the filing of a Marketing Authorisation Application (“MAA”) to the European Medicines Agency seeking marketing approval for vernakalant (iv) in the European Union. 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 2011, BRINAVESS was also granted marketing approval in several countries outside of the European Union. As of Q2-2012, BRINAVESS is approved for marketing in 42 countries outside North America. 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.

BRINAVESS™ has been commercially launched by Merck in a number of countries where it is approved for marketing, and further product launches are planned for the remaining countries for which marketing approval has been obtained. We continue to earn royalty revenue from Merck for the sale of BRINAVESS™ in countries in which it is marketed.  

North America
 
In 2006, our former partner, 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 Q4-2010, we announced that Astellas suspended patient enrolment 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 commercialization of vernakalant (iv) in North America. Merck and the FDA have agreed to close the ACT 5 trial and analyze the results generated to date.  Merck has begun discussions with the FDA to determine the next steps for the development of vernakalant (iv) in the United States and we will announce those plans once they are agreed upon and are final. Merck is conducting non-clinical studies in support of vernakalant (iv) in North America.

 
2

 
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. 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 Q4-2010, we announced that Merck’s current review of vernakalant (oral) was completed, 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 was initiated in 2011. This trial was successfully completed in February 2012.  In Q1-2012, Merck communicated to us its decision to discontinue further development of vernakalant (oral).  We are exploring our alternatives under the collaboration and license agreement with Merck.
  

CORPORATE DEVELOPMENT

Long-term debt
 
In January 2012, we received an advance of $25 million from Merck pursuant to a $100 million secured, interest-bearing credit facility granted to us under the 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, 2017.

Merck’s development plans for Vernakalant (oral)
 
In March 2012, we announced Merck’s decision to discontinue further development of vernakalant (oral).  We understand that Merck’s decision was based on its assessment of the regulatory environment and projected development timeline.  In response to this decision, we have reduced our annual operating expenditures.

 
3

 
Workforce reduction  
 
On March 19, 2012, we reduced our workforce in response to Merck’s decision to discontinue further development of vernakalant (oral) and our plans to reduce our annual operating expenses. We expect to record total employee termination benefit charges of $1.1 million related to employee severance packages and outplacement support. For the six months June 30, 2012, we incurred employee termination charges of $1.0 million, which is included in our Consolidated Statements of Operations and Comprehensive Loss. Of this charge, $0.8 million is included in research and development and $0.2 million is included in general and administration expenses depending on the functions associated with the terminated employees.  We expect all payments for employee termination benefits to be made by the end of the third quarter of 2012.
 
On July 9, 2012, we announced a further reduction of our workforce which decreased the total number of employees by approximately 85%. We expect to incur up to $5.0 million of employee termination benefit charges and other charges related to this reduction in workforce over the remainder of 2012.
 
As a result of our workforce reductions, we expect our employee related expenses to be significantly reduced.

Management Change  
 
On July 3, 2012, we announced that CEO Doug Janzen has left the Company. Dr. William Hunter, a member of the Company’s board of directors, has been appointed interim CEO. His first tasks are expected to be a review of all current activities of the Company with the immediate objective of optimizing the spend rate, defining the strategic direction of the Company and putting in place a plan for identifying a long term CEO.
 
 
4

 
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)
Approvable letter received in 2008.
$  102.3
       
 
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
 
Phase 3 ACT 5 study
 
Post Approval Study
Patient enrollment initiated in Q3-2010.
 
Study closed, awaiting results to date.
 
Spectrum (post approval safety study) initiated in 2011.
 
Vernakalant (oral)
Phase 2b Clinical Trial
Final results released in Q3-2008
109.4
       
 
Pharmacokinetic/ pharmacodynamics studies
Phase 1 PK/PD study completed
 
28-day Phase 1 trial completed
 
Development discontinued by Merck
 
Current Pre-clinical Projects
Pre-Clinical Stage
Pre-clinical studies
18.2

 
 
5

 
The following provides a description of our clinical development efforts for each of our projects during the quarter:

Vernakalant (iv)
 
During Q2-2012 we continued to support Merck in the development of vernakalant (iv) globally.    

Vernakalant (oral)
 
In Q1-2012, Merck communicated to us its decision to discontinue further development of vernakalant (oral).  During Q2, we have been evaluating our options and rights to vernakalant (oral) under the terms of our license agreement.

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.Our lead pre-clinical product candidates leverage our expertise in ion channel and cardiovascular research.

We continue to review the external world for other assets which would complement our current programs.

In light of Merck’s decision to discontinue further development of vernakalant (oral), and our recent change in management, we are undertaking a process to review all our strategic options.


INTERNAL CONTROLS OVER FINANCIAL REPORTING

There were no changes in our internal controls over financial reporting that occurred during the six months ended June 30, 2012 that have materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting. We will be assessing the impact of our latest workforce reduction in July on 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 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, and stock-based compensation expense.

 
6

 
There were no material changes to our critical accounting estimates during the six months ended June 30, 2012, from those disclosed in the MD&A for the year ended December 31, 2011.

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 Note 2 of our annual consolidated financial statements for the year ended December 31, 2011. There have been no changes in these accounting policies during the six months ended June 30, 2012, except as described below.

Changes in Significant Accounting Policies

Fair Value Measurements:
 
On January 1, 2012, we prospectively adopted amendments issued by the Financial Accounting Standards Board (“FASB”) to achieve common fair value measurement and disclosure requirements in U.S. GAAP and International Financial Reporting Standards (IFRS). These 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. The adoption of the amendments did not have a material impact on our financial position, results of operations or cash flows for the periods presented.

Comprehensive Income:
 
On January 1, 2012, we prospectively adopted amendments issued by the FASB on the presentation of comprehensive income. The amendments give an entity the option 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. The adoption of the amendments did not have a material impact on the presentation of our results of operations for the periods presented.


RESULTS OF OPERATIONS

Second Quarter Overview
 
The lower net loss in Q2-2012 compared to Q1-2012 was mainly due to reduction in employee related expenses of $0.6 million and reduction in termination charges of $0.6 million related to our workforce reduction in Q1-2012.  In addition, expenses related to development and exploratory projects decreased by $0.3 million in Q2-2012 compared to Q1-2012. The lower expenses in Q2-2012 were partially offset by a decrease in revenue of $0.2 million.

Three and Six Months Ended June 30, 2012 Compared to Three and Six Months Ended June 30, 2011
 
We recorded a net loss of $5.7 million ($0.09 per share) for the three months ended June 30, 2012 (Q2-2012), compared to a net loss of $7.7 million ($0.13 per share) for the three months ended June 30, 2011 (Q2-2011). On a year-to-date basis, we recorded a net loss of $12.6 million ($0.21 per share) for the six months ended June 30, 2012, compared to a net loss of $14.9 million ($0.24 per share) for the six months ended June 30, 2011.

 
7

 
The net losses for the three and six months ended June 30, 2012 and 2011 were largely due to expenditures incurred on clinical development efforts and pre-clinical research projects. The net losses for the three and six months ended June 30, 2012 include employee termination charges of $0.2 million and $1.0 million, respectively, related to our workforce reduction in March in addition to research and development expenditures.

For the remainder of the year, we expect to continue to incur a net loss as our expenses are expected to continue to be greater than our revenues from licensing, research collaborative and other fees. In Q3-2012, we expect to incur further employee termination charges and other charges related to the workforce reduction and management changes in July. In aggregate, the workforce reductions in 2012 are expected to reduce our employee related expenses by $8.9 million annually. We expect our net loss per quarter to decrease starting in Q4-2012.

Revenue
 
Revenue for Q2-2012 was $0.2 million, a decrease of $0.2 million from $0.4 million in Q2-2011. On a year-to-date basis, revenue for the six months ended June 30, 2012 and 2011 was $0.6 million and $0.8 million, respectively. Revenue is comprised of licensing and other fees and research collaborative fees we received from our collaborative partners.

Licensing and other fees represent recognition of revenue related to upfront payments, milestone payments, royalties, and other fees from our collaborative partners.  Licensing and other fees for the three and six months ended June 30, 2012 and 2011 were not significant.

Royalty revenue is expected to grow from 2011 levels as BRINAVESS™ gains market acceptance and is launched in additional countries throughout Europe and other markets worldwide. We also expect royalty revenue to grow as additional approvals are achieved and pricing and reimbursement is attained.

Research collaborative fees comprise contract research fees and project management fees from our collaborative partners. Research collaborative fees in Q2-2012 were not significant, compared to $0.3 million in Q2-2011. On a year-to-date basis, we recorded research and collaborative fees of $0.3 million and $0.5 million for the six months ended June 30, 2012 and 2011, respectively. Research collaborative fees are not expected to be significant for the remainder of the year.  

In the future, we may earn additional revenue from our collaboration and licensing agreements with Merck for the development of vernakalant (iv) or from future partnerships around any of our pipeline products.
 
 
8

 
Research and Development Expenditures

(in thousands of U.S. dollars)
 
For the Three Months
Ended June 30
   
For the Six Months
Ended June 30
 
   
2012
   
2011
   
2012
   
2011
 
Clinical Development Programs
                       
Vernakalant (iv)
  $ 177     $ 1,555     $ 586     $ 3,243  
Vernakalant (oral)
    27       476       57       727  
    $ 204     $ 2,031     $ 643     $ 3,970  
Research Projects
                               
Other projects (including pre-clinical studies)
    2,213       2,042       5,319       3,909  
Total research and development expenditures
  $ 2,417     $ 4,073     $ 5,962     $ 7,879  

Research and development (“R&D”) expenditures were $2.4 million for Q2-2012 as compared to $4.1 million for Q2-2011. We incurred total R&D expenditures of $6.0 million for the six months ended June 30, 2012, compared to $7.9 million for the same period in 2011. R&D expenditures consist of clinical development and research expenditures. Included in R&D expenditures for the three and six months ended June 30, 2012 is $0.2 million and $0.8 million, respectively, of employee termination benefit charges related to our workforce reduction in March.

In Q3-2012, we expect to incur R&D employee termination charges and other charges up to $3.0 million related to our workforce reduction announced on July 9, 2012. Thereafter, we expect our R&D expenditures to decrease due to our ongoing cost savings measures.

Clinical Development Expenditures
 
Clinical development expenditures primarily consist of wages and benefits (including stock-based compensation), contract service agreement costs and consulting fees relating to our clinical stage development programs.

Clinical development expenditures for Q2-2012 were $0.2 million as compared to $2.0 million for Q2-2011. For the six months ended June 30, 2012 clinical development expenditures were $0.6 million as compared to $4.0 million for the same period in 2011. The decrease of $1.8 million and $3.4 million in expenditures for Q2-2012 and year-to-date, respectively, was primarily due to reduced costs for vernakalant (iv) as a result of patient enrolment for the ACT 5 trial being suspended, as well as, the consequent reallocation of internal staff to work on pre-clinical research projects.

For the three and six months ended June 30, 2012, we continued to incur costs in support of the vernakalant program.

For the remainder of 2012, we will continue to incur costs related to the vernakalant (iv) program, including costs to assist Merck and the FDA in determining a path forward and our portion of any development costs related to vernakalant (iv) in North America. We expect clinical development expenditures to be lower than 2011 as we implement our cost savings measures.
 
 
9

 
Research Expenditures
 
Research expenditures primarily consist of wages and benefits (including stock-based compensation), material & lab costs, consulting fees, and contract research agreement costs relating to our pre-clinical and early stage research projects.

Research expenditures for Q2-2012 were $2.2 million as compared to $2.0 million for Q2-2011. For the six months ended June 30, 2012 research expenditures were $5.3 million as compared to $3.9 million for the same period in 2011. The increase of $0.2 million and $1.4 million in expenditures for Q2-2012 and year-to-date, respectively, was primarily due to increased allocation of internal staff resources from clinical development to pre-clinical research projects.

For the remainder of 2012, our costs related to the development of our pre-clinical and early stage research projects are expected to be lower than Q1 and Q2-2012.

General and Administration Expenditures
 
General and administration (“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.

G&A expenditures for Q2-2012 were $2.2 million as compared to $3.5 million for Q2-2011. On a year-to-date basis, we incurred total G&A expenditures of $4.9 million for the six months ended June 30, 2012, compared to $6.7 million for the same period in 2011. The decrease in G&A expenditures related primarily to a decrease in wages and benefits (including stock-based compensation) as a result of our workforce reduction in March. Included in G&A expenditures for six months ended June 30, 2012 is $0.2 million of employee termination benefit charges.

In Q3-2012, we expect to incur G&A employee termination charges and other charges up to $2.0 million related to our workforce reduction announced on July 9, 2012. Thereafter, we expect our G&A expenditures to decrease due to our ongoing cost savings measures.
 
Other Income and Expense
 
Other income and expense consists primarily of interest expense on our $50 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 Q2-2012 and Q2-2011 was $1.0 million and $0.3 million, respectively. For the six months ended June 30, 2012 and 2011, other expense was $1.9 million and $0.6 million, respectively. The increase in other expense related primarily to the additional interest expense on the $25.0 million advance we received from Merck in Q1-2012.
 
 
10

 
QUARTERLY FINANCIAL INFORMATION

The following table summarizes selected unaudited consolidated financial data for each of the last eight quarters, prepared in accordance with the U.S. GAAP:

   
Quarter ended
 
(In thousands of U.S. dollars except per share amounts)
 
June 30,
2012
   
March 31,
2012
   
December 31,
2011
   
September 30,
2011
 
                         
Total revenue
  $ 209     $ 433     $ 401     $ 274  
Research and development
    2,417       3,545       3,442       3,903  
General and administration
    2,210       2,739       2,095       2,764  
Net loss
  $ (5,677 )   $ (6,970 )        $ (5,898 )        $ (7,153 )
Loss per share
                               
Basic and diluted
  $ (0.09 )   $ (0.11 )          $ (0.10 )          $ (0.12 )
                                 
 
(In thousands of U.S. dollars except per share amounts)
 
Quarter ended
 
 
June 30,
2011
   
March 31,
2011
   
December 31,
2010
   
September 30,
2010
 
                                 
Total revenue
  $ 443     $ 387     $ 374     $ 30,221  
Research and development
    4,073       3,806       4,417       3,486  
General and administration
    3,466       3,224       2,740       3,505  
Net income (loss)
  $ (7,723 )   $ (7,146 )   $ (7,302 )   $ 22,768  
Income (loss) per share
                               
Basic and diluted
    (0.13 )     (0.12 )     (0.12 )     0.37  

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 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 Expenditures:
 
The timing of clinical trials and research work performed resulted in the variations in R&D expenditures.

General and Administration Expenditures:
 
The timing of stock option grants, consulting fees and corporate costs resulted in the variations in G&A expenditures.
 
 
11

 
LIQUIDITY AND CAPITAL RESOURCES

Our operational activities during Q2-2012 were financed mainly by working capital carried forward from the preceding fiscal year and a $25 million advance under our credit facility with Merck. This credit facility has not been impacted by Merck’s decision to discontinue further development of vernakalant (oral). We believe that our cash position as of June 30, 2012, 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.  Our cash reserves will continue to fund pre-clinical research efforts and our portion of costs related to the development of vernakalant and business development activities related to our external program review.

At June 30, 2012, we had working capital of $60.0 million compared to $47.2 million at December 31, 2011. We had available cash reserves comprised of cash and cash equivalents of $60.7 million at June 30, 2012 compared to $48.6 million at December 31, 2011.

Sources and Uses of Cash

(in thousands of U.S. dollars)
 
For the Three Months
Ended June 30,
   
For the Six Months
Ended June 30,
 
   
2012
   
2011
   
2012
   
2011
 
Cash used in operating activities
  $ (4,803 )   $ (8,024 )     (12,790 )   $ (15,300 )
Cash used in investing activities
    (26 )     (487 )     (225 )     (785 )
Cash provided by financing activities
    -       -       25,000       358  
Effect of foreign exchange rate on cash and cash equivalents
    (16 )      20        47        155  
Net increase (decrease) in cash and cash equivalents
    (4,845 )   $ (8,491 )      12,032     $ (15,572 )

Cash used in operating activities in Q2-2012 was $4.8 million compared to $8.0 million in Q2-2011. The decrease of $3.2 million in cash used was primarily due to decrease in wages and benefits resulting from our workforce reduction, reduced spending related to current development and exploratory projects, and timing of payments of trade payables. Cash used in operating activities for the six months ended June 30, 2012 was $12.8 million, a decrease of $2.5 million from $15.3 million used in operating activities for the same period in 2011.

Cash used in investing activities was insignificant in Q2-2012 compared to $0.5 million in Q2-2011, and was $0.3 million and $0.8 million for the six months ended June 30, 2012 and 2011, respectively. Cash used in investing activities related to the purchase of equipment and patent costs.

No cash was provided by financing activities in Q2-2012 and Q1-2011. On a year-to-date basis, cash provided by financing activities for the six months ended June 30, 2012 was $25.0 million and $0.4 million for the same period in 2011.  We received a $25.0 million advance from Merck in 2012 while financing in 2011 consisted mainly of employee stock option exercises.
 
 
12

 
Contractual Obligations
 
As of June 30, 2012 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 U.S. dollars)
 
2012
   
2013
   
2014
   
2015
   
2016
   
There-after
   
Total
 
Long-term debt
 
Nil
   
Nil
   
Nil
   
Nil
      25,000 (1)     25,000 (1)     50,000  
Interest expense on long-term debt(2)
    2,317       4,596       4,596       4,596       4,609       2,298       23,012  
Operating lease obligations
    846       1,691       1,294       1,220       1,220       5,405       11,676  
Other commitments
    378       63       8    
Nil
   
Nil
   
Nil
      449  
Total
  $ 3,541     $ 6,350     $ 5,898     $ 5,816     $ 30,829     $ 32,703     $ 85,137  

(1)  
These include two $25.0 million advances, which must be repaid in full by December 31, 2016 and December 31, 2017, respectively. We may, at our option, repay all or a portion of these advances prior to December 31, 2016 and December 31, 2017, respectively, without premium or penalty.
(2)  
Interest expense obligations have been calculated based on the interest rate in effect at June 30, 2012.

Outstanding Share Capital
 
As of August 7, 2012, there were 61,129,091 common shares issued and outstanding, and 5,222,648 common shares issuable upon the exercise of outstanding stock options (of which 3,761,831 were exercisable) at a weighted average exercise price of CAD $4.84 per share.

RELATED PARTY TRANSACTIONS

Included in accounts payable and accrued liabilities as of June 30, 2012 was $0.5 million (December 31, 2011 - $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 $0.5 million for the six months ended June 30, 2012 (2011 - $0.5 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.
 
 
13

 
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 June 30, 2012, our cash and cash equivalents were primarily held as 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.

 
 
14

EX-99.2 3 exh_992.htm EXHIBIT 99.2 exh_992.htm
Exhibit 99.2

 

 

 

 
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 June 30, 2012 and 2011
(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) 

 
   
June 30,
2012
   
December 31,
2011
 
             
Assets
           
Current assets:
           
Cash and cash equivalents
  $ 60,676     $ 48,644  
Accounts receivable
    1,502       1,248  
Prepaid expenses and other assets
    391       628  
      62,569       50,520  
                 
Property and equipment
    1,743       1,967  
Intangible assets
    1,519       1,548  
    $ 65,831     $ 54,035  
                 
Liabilities and Stockholders’ Equity
               
Current liabilities:
               
Accounts payable and accrued liabilities (note 4)
  $ 2,383     $ 3,188  
Current portion of deferred leasehold inducement
    118       116  
      2,501       3,304  
                 
Deferred leasehold inducement
    386       445  
Long-term debt (note 5)
    50,000       25,000  
      52,887       28,749  
                 
Stockholders’ equity:
               
Common stock
    262,097       262,097  
   Authorized - unlimited number with no par value
               
   Issued and outstanding – 61,129,091 (2011 – 61,129,091)
               
Additional paid-in capital
    32,513       32,208  
Deficit
    (299,851 )     (287,204 )
Accumulated other comprehensive income
    18,185       18,185  
      12,944       25,286  
    $ 65,831     $ 54,035  
 
 
Related party transactions (note 8)

 
Contingencies (note 9)

 
Subsequent events (note 10)
 
 
See accompanying notes to the consolidated financial statements.
 
 
 

 
CARDIOME PHARMA CORP.
Consolidated Statements of Operations and Comprehensive 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
   
Six months ended
 
   
June 30,
2012
   
June 30,
2011
   
June 30,
2012
   
June 30,
2011
 
Revenue:
                       
Licensing and other fees
  $ 170     $ 153     $ 319     $ 281  
Research collaborative fees
    39       290       323       549  
      209       443       642       830  
Expenses:
                               
Research and development
    2,417       4,073       5,962       7,879  
General and administration
    2,210       3,466       4,949       6,690  
Amortization
    235       280       473       554  
      4,862       7,819       11,384       15,123  
Operating loss
    (4,653 )     (7,376 )     (10,742 )     (14,293 )
                                 
Other expenses (income):
                               
Interest expense
    1,144       552       2,229       1,099  
Other income
    (154 )     (211 )     (308 )     (392 )
Foreign exchange loss (gain)
    34       6       (16 )     (131 )
      1,024       347       1,905       576  
Net loss and comprehensive loss for the period
  $ (5,677 )   $ (7,723 )   $ (12,647 )   $ (14,869 )
Basic and diluted loss per common share(1)
  $ (0.09 )   $ (0.13 )   $ (0.21 )   $ (0.24 )
Weighted average common shares outstanding
    61,129,091       61,129,091       61,129,091       61,122,463  
 
 
(1) Basic and diluted loss per common share based on the weighted average number of common shares outstanding during the period.
 
 
See accompanying notes to the consolidated financial statements.
 
 
 

 
CARDIOME PHARMA CORP.
Consolidated Statements of Stockholders’ Equity
For the six months ended June 30, 2012 and 2011
(Unaudited)
(Expressed in thousands of U.S. dollars)
(Prepared in accordance with U.S. GAAP)


For the six months ended June 30, 2012
 
Common
stock
   
Additional
paid-in capital
   
Deficit
   
Accumulated
other
comprehensive
income
   
Total
stockholders’
equity
 
Balance at December 31, 2011
  $ 262,097     $ 32,208     $ (287,204 )   $ 18,185     $ 25,286  
Net loss
    -       -       (12,647 )     -       (12,647 )
Stock-based compensation expense recognized
    -       305       -       -       305  
Balance at June 30, 2012
  $ 262,097     $ 32,513     $ (299,851 )      $ 18,185     $ 12,944  
                                         
 
For the six months ended June 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
    -       -       (14,869 )     -       (14,869 )
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-based compensation expense recognized
    -       1,021       -       -       1,021  
Balance at June 30, 2011
  $ 262,097     $ 31,298     $ (274,153 )   $ 18,185     $ 37,427  
 
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
   
Six months ended
 
   
June 30,
2012
   
June 30,
2011
   
June 30,
2012
   
June 30,
2011
 
Cash flows from operating activities:
                       
Net loss for the period
  $ (5,677 )   $ (7,723 )   $ (12,647 )   $ (14,869 )
Items not affecting cash:
                               
Amortization
    235       280       473       554  
Stock-based compensation
    175       453       305       1,021  
Deferred leasehold inducement
    (30 )     (20 )     (57 )     (71 )
Unrealized foreign exchange loss (gain)
    8       9       (39 )     (101 )
Other
    (26 )     -       5       -  
Changes in operating assets and liabilities:
                               
Accounts receivable
    116       (348 )     (258 )     (514 )
Prepaid expenses and other assets
    411       358       237       469  
Accounts payable and accrued liabilities
    (15 )     (1,033 )     (809 )     (1,789 )
Net cash used in operating activities
    (4,803 )     (8,024 )     (12,790 )     (15,300 )
                                 
Cash flows from investing activities:
                               
Purchase of property and equipment
    -       (418 )     (90 )     (533 )
Purchase of intangible assets
    (26 )     (69 )     (135 )     (252 )
Net cash used in investing activities
    (26 )     (487 )     (225 )     (785 )
                                 
Cash flows from financing activities:
                               
Issuance of common stock upon exercise of stock options
    -       -       -       358  
Proceeds from draws of long-term debt
    -       -       25,000       -  
Net cash provided by financing activities
    -       -       25,000       358  
                                 
Effect of foreign exchange rate changes on cash and cash equivalents
    (16 )     20       47       155  
Increase (decrease) in cash and cash equivalents during the period
    (4,845 )     (8,491 )     12,032       (15,572 )
Cash and cash equivalents, beginning of period
    65,521       69,807       48,644       76,888  
Cash and cash equivalents, end of period
  $ 60,676     $ 61,316     $ 60,676     $ 61,316  
                                 
Supplemental cash flow information:
                               
Interest paid
  $ 1,147     $ 556     $ 2,237     $ 1,110  
Interest received
    3       4       7       11  
 
 
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 six months ended June 30, 2012 and 2011

 
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, 2011 filed with the appropriate securities commissions. The results of operations for the three and six month periods ended June 30, 2012 and 2011 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)  Fair Value Measurements:
 
On January 1, 2012, the Company prospectively adopted amendments issued by the Financial Accounting Standards Board (FASB) to achieve common fair value measurement and disclosure requirements in U.S. GAAP and International Financial Reporting Standards (IFRS). These 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. The adoption of the amendments did not have a material impact on the Company’s financial position, results of operations or cash flows for the periods presented.
 
 (b)  Comprehensive Income:
 
On January 1, 2012, the Company prospectively adopted amendments issued by the FASB on the presentation of comprehensive income. The amendments give an entity the option 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. The adoption of the amendments did not have a material impact on the presentation of the Company’s results of operations for the periods presented.

 
 

 
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 six months ended June 30, 2012 and 2011


3.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 cash and cash equivalents, accounts receivable, accounts payable and accrued liabilities approximate carrying values because of their short-term nature.
 
As of June 30, 2012, 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.
 
4.Accounts payable and accrued liabilities:
 
Accounts payable and accrued liabilities comprise:
 
             
   
June 30,
   
December,
 
   
2012
   
2011
 
             
Trade accounts payable
  $ 939     $ 743  
Accrued contract research
    458       1,066  
Employee-related accruals
    455       746  
Other accrued liabilities (1)
    531       633  
                 
    $ 2,383     $ 3,188  
 
(1)  
Included in other accrued liabilities at June 30, 2012 is an amount of $469 (December 31, 2011 - $59) owing to a related party (note 8).

 
5.Long term debt:  
 
Pursuant to a collaboration and license agreement with Merck & Co., Inc. (Merck), Merck has granted the Company an interest-bearing credit facility of up to $100 million, secured by a first priority interest to the Company’s patents and all associated proceeds. This credit facility can be accessed in amounts of up to $25 million annually, subject to certain minimums, from January 1, 2010 to December 31, 2013, with each advance to be fully repaid on December 31st, six years after the year in which the Company provides Merck written notice to extend the credit under the credit facility. Interest accrues at LIBOR, which resets annually, plus 8% per annum and is payable at the end of each calendar quarter. This credit facility has not been impacted by Merck’s decision to discontinue further development of vernakalant (oral).
 
The Company borrowed $25 million under this facility during the six months ended June 30, 2012 and $25 million during the year ended December 31, 2010. The Company may at its option, repay all or a portion of the advances from time to time prior to the maturity date without premium or penalty. These advances must be repaid in full by December 31, 2017 and December 31, 2016, respectively.

 
 

 
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 six months ended June 30, 2012 and 2011


6.Collaborative agreements:  
 
Pursuant to a collaboration and license agreement with Merck & Co., Inc., the Company granted Merck exclusive global rights to vernakalant (oral).
 
On March 19, 2012, the Company announced Merck’s decision to discontinue further development of vernakalant (oral).
 
7.Workforce reduction:  
 
On March 19, 2012, the Company reduced its workforce in response to Merck’s decision to discontinue further development of vernakalant (oral) and the Company’s plans to reduce its annual operating expenses. The Company expects to record total employee termination benefit charges of $1,073 related to employee severance packages and outplacement support. For the six months ended June 30, 2012, the Company has incurred employee termination charges of $969, which is included in the Company’s consolidated statements of operations and comprehensive loss. Of this charge, $779 is included in research and development and $190 is included in general and administration expenses depending on the functions associated with the terminated employees.  As at June 30, 2012, $742 in cash payments have been made and $221 related to employee termination benefits is included in accounts payable and accrued liabilities.  The Company expects all payments for employee termination benefits to be made by the end of the third quarter of fiscal 2012.
 
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 six months ended June 30, 2012, the Company has incurred legal fees of $489 (June 30, 2011 - $552) for services provided by the law firm relating to general corporate matters. Included in accounts payable and accrued liabilities at June 30, 2012 is an amount of $469 (December 31, 2011 - $59) owing to the legal firm.
 
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
 
 
 

 
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 six months ended June 30, 2012 and 2011


9.Contingencies (continued):
 
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.

 
10.Subsequent events:
 
On July 3, 2012, the Company announced that CEO Doug Janzen has left the Company. Dr. William Hunter, a member of the Company’s board of directors, has been appointed interim CEO.
 
On July 9, 2012, the Company announced a further reduction of its workforce in response to Merck’s decision to discontinue further development of vernakalant (oral). The workforce reduction eliminates all positions focused on internal research activities along with certain supporting functions. The reduction in workforce will decrease the total number of employees by approximately 85%.
 

 
 

EX-99.3 4 exh_993.htm EXHIBIT 99.3 exh_993.htm
Exhibit 99.3
 
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
August 7, 2012

3.  
News Release
August 7, 2012 - Vancouver, Canada

4.  
Summary of Material Change
Cardiome Pharma Corp. reported financial results for the second quarter ended June 30, 2012.  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:                Curtis Sikorsky
Title:                  Chief Financial Officer
Phone No.:       604-677-6905

9.  
Date of Report
August 8, 2012



Per:  Curtis Sikorsky”
Curtis Sikorsky,
Chief Financial Officer
EX-99.4 5 exh_994.htm EXHIBIT 99.4 exh_994.htm
Exhibit 99.4
 
Form 52-109F2
Certification of interim filings - full certificate

I, William Hunter, 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 June 30, 2012.

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 April 1, 2012 and ended on June 30, 2012 that has materially affected, or is reasonably likely to materially affect, the issuer’s ICFR.


Date: August 8, 2012

William Hunter
William Hunter
President and Chief Executive Officer

EX-99.5 6 exh_995.htm EXHIBIT 99.5 exh_995.htm
Exhibit 99.5
 
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 June 30, 2012.

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 April 1, 2012 and ended on June 30, 2012 that has materially affected, or is reasonably likely to materially affect, the issuer’s ICFR.


Date: August 8, 2012

Curtis Sikorsky
Curtis Sikorsky
Chief Financial Officer