0001171843-12-004139.txt : 20121114 0001171843-12-004139.hdr.sgml : 20121114 20121113173206 ACCESSION NUMBER: 0001171843-12-004139 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 6 CONFORMED PERIOD OF REPORT: 20120930 FILED AS OF DATE: 20121114 DATE AS OF CHANGE: 20121113 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: 121200063 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_111312.htm FORM 6-K f6k_111312.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, 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: November 13, 2012
/s/ JENNIFER ARCHIBALD
 
Jennifer Archibald
 
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 November 13, 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 nine months ended September 30, 2012 is as of November 8, 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 nine months ended September 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.  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: 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.  Atrial fibrillation is an arrhythmia or abnormal rhythm, of the upper chambers of the heart.

Vernakalant
 
Exclusive global rights to the intravenous and oral formulations of vernakalant hydrochloride (“vernakalant (iv) and vernakalant (oral)” respectively) are held by Merck under two separate collaboration and license agreements.  On September 25, 2012, Merck gave notice to us of its termination of both collaboration and license agreements.  The terminations will be effective after the notice period pursuant to the terms of the collaboration and license agreements.  Upon the effective dates of the terminations, the Company will have exclusive global rights to vernakalant (iv) and vernakalant (oral).  We are in discussions with Merck to ensure a smooth transition of activities.

 
1

 
Vernakalant (iv)
 
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 were assumed by Merck without change. We 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 the development costs and future commercialization costs for vernakalant (iv) in North America pursuant to the collaboration and license agreement.  
 
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.
 
In Q3-2012, we announced Merck will return the global marketing and development rights for vernakalant (iv). Once the rights have been returned, we will be responsible for all future development and commercialization costs for vernakalant (iv) worldwide.

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.  
 
BRINAVESS™ has been commercially launched by Merck in a number of countries where it is approved for marketing.  We will continue to earn royalty revenue from Merck for the sale of BRINAVESS™ in countries in which it is marketed until the global marketing and development rights for vernakalant (iv) are returned to us.  We intend to continue to advance the launch of BRINAVESS worldwide and to providecontinued access to the product.
 
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.  In the Asia-Pacific region, Merck initiated a Phase 3 trial in Q3-2010 that is expected to support regulatory applications in additional territories for which marketing approval has not yet been attained.  This study is currently suspended pending the return of rights from Merck.  In 2011, Merck initiated SPECTRUM, a post-approval safety study.  This study is ongoing and we intend to continue this study upon the return of rights from Merck.

 
 
2

 
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 terminated the ACT 5 trial.  Merck has begun discussions with the FDA to determine the next steps for the development of vernakalant (iv) in the United States.  Upon the return of rights from Merck, we intend to continue these discussions with the FDA.  
 
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.  

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.  Pursuant to the collaboration and license agreement, all development efforts and expenses for vernakalant (oral) 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 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).  In Q3-2012, we announced Merck will return the global marketing and development rights for vernakalant (oral).  Once the rights have been returned to us, we will evaluate the appropriate development path for vernakalant (oral) and will be responsible for all future development and commercialization costs.

CORPORATE DEVELOPMENT

Merck’s return of rights for Vernakalant (iv) and Vernakalant (oral)
 
In March 2012, we announced Merck’s decision to discontinue further development of vernakalant (oral).  In response to this decision, we conducted several workforce reductions in an effort to reduce our annual operating expenditures and align our operations with our strategic plans.  In September 2012, we announced that Merck will return the global marketing and development rights for both vernakalant (iv) and vernakalant (oral) to us.  We are working with Merck to ensure a smooth transition of activities related to vernakalant.

 
3

 
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.
 
In September 2012, Merck gave notice to us of its termination of the collaboration and license agreement. As a result of the notice of termination, Merck does not have an obligation to make further advances to us under the credit facility. Terms of the existing $50 million advanced under the credit facility prior to the notice of termination remain the same.  We are currently in discussions with Merck about our outstanding loan balance.

Restructuring   
 
On March 19, 2012, we reduced our workforce in response to Merck’s decision to discontinue further development of vernakalant (oral).  On July 9, 2012, we further reduced our workforce by eliminating positions focused on internal research activities along with certain supporting functions. We expect costs relating to employee severance and benefit arrangements to total $5.6 million. For the nine months ended September 30, 2012, we recognized employee termination charges of $5.5 million, primarily relating to employee severance packages and outplacement support.  These charges are included as part of restructuring in our Consolidated Statements of Operations and Comprehensive Loss. We expect all payments for employee termination benefits to be made by the end of the first quarter of 2013.
 
As a result of the workforce reductions, we exited redundant leased facilities and terminated certain contracts. For the nine months ended September 30, 2012, we recognized idle-use expense and other charges of $3.8 million. These charges included $0.1 million of non-cash items, and were partially offset by the immediate recognition of $0.5 million of deferred leasehold inducement. The idle-use expense and other charges are included as part of restructuring in our Consolidated Statements of Operations and Comprehensive Loss. We expect all payments for contract termination costs and other charges to be made by the end of fiscal 2012.
 
For the nine months ended September 30, 2012, we recorded impairment charges of $0.7 million on leasehold improvements associated with idle space as well as certain computer and office equipment.
 
As a result of our restructuring efforts, we expect our future employee and facility 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.
 
On September 20, 2012, we announced the appointment of Jennifer Archibald as CFO following the resignation of Curtis Sikorsky who continues to serve the Company in a consulting capacity.

 
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
 
$  102.4
             
   
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 Suspended pending transition
 
Study terminated
 
Spectrum (post approval safety study) initiated in 2011  
Study continuing
   
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
 
   
Pre-clinical Projects
 
Pre-Clinical Stage
 
Pre-clinical studies
 
      17.8

 
 
5

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

Vernakalant (iv)
 
As a result of Merck’s notice of termination of our collaboration and license agreements for vernakalant (iv) during Q3-2012, the Phase 3 Asia Pacific study has been suspended pending the return of rights.  Merck will continue to support the post approval study until its transition to us is complete.

Vernakalant (oral)
 
In Q1-2012, Merck communicated to us its decision to discontinue further development of vernakalant (oral).  Given Merck’s notice of termination of our collaboration and license agreement for vernakalant (oral) during Q3-2012, we are exploring developmental options related to this asset in anticipation of the return of its global rights.

Other Projects
 
We continue to support pre-clinical research and development work.  The focus of the technology 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.
 
In light of Merck’s recent return of the global marketing and development rights for both vernakalant (iv) and vernakalant (oral), 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 nine months ended September 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.
 
There were no material changes to our critical accounting estimates during the nine months ended September 30, 2012, from those disclosed in the MD&A for the year ended December 31, 2011.
 
 
6

 
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 nine months ended September 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

Third Quarter Overview
 
During the third quarter of 2012, we furtherreduced our workforce by eliminating positions focused on internal research activities along with certain supporting functions. As a result of the workforce reductions, we have exited redundant leased facilities and terminated certain contracts.
 
The higher net loss in Q3-2012 compared to Q2-2012 was mainly due to restructuring charges of $9.0 million. The loss in Q3-2012 was partially offset by a decrease in research and development expenditures of $2.0 million related to the elimination of positions focused on internal research activities.

Three and Nine Months Ended September 30, 2012 Compared to Three and Nine Months Ended September 30, 2011
 
We recorded a net loss of $13.4 million ($0.22 per share) for the three months ended September 30, 2012 (Q3-2012), compared to a net loss of $7.2 million ($0.12 per share) for the three months ended September 30, 2011 (Q3-2011). On a year-to-date basis, we recorded a net loss of $26.1 million ($0.43 per share) for the nine months ended September 30, 2012, compared to a net loss of $22.0 million ($0.36 per share) for the nine months ended September 30, 2011.
 
 
7

 
The net losses for the three and nine months ended September 30, 2012 were largely due to restructuring charges of $9.0 million and $10.0 million, respectively, related to our workforce reduction, exit of redundant leased facilities, and consequent termination of certain contracts.  The higher losses in fiscal 2012 were partially offset by a decrease in expenditures incurred on clinical development efforts and pre-clinical research projects of $3.5 million and $6.2 million for the three and nine months ended September 30, 2012, respectively.
 
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. As a result of our restructuring efforts, we expect our employee and ongoing facility lease expenses to be significantly reduced.

Revenue
 
Revenue for Q3-2012 was $0.1 million, a decrease of $0.2 million from $0.3 million in Q3-2011. On a year-to-date basis, revenue for the nine months ended September 30, 2012 and 2011 was $0.7 million and $1.1 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 nine months ended September 30, 2012 and 2011 were not significant.
 
We expect to continue to earn royalty revenue pursuant to our collaboration and licensing agreements with Merck until the global rights to vernakalant is returned to us, at which time, we expect to begin earning revenue from the sale of the product.
 
Research collaborative fees comprise contract research fees and project management fees from our collaborative partners. Research collaborative fees in Q3-2012 were not significant, compared to $0.2 million in Q3-2011. On a year-to-date basis, we recorded research and collaborative fees of $0.3 million and $0.7 million for the nine months ended September 30, 2012 and 2011, respectively. Research collaborative fees are not expected to be significant for the remainder of the year.  


 
 
8

 
Research and Development Expenditures

(in thousands of U.S. dollars)
 
For the Three Months
Ended September 30
   
For the Nine Months
Ended September 30
 
   
2012
   
2011
   
2012
   
2011
 
Clinical Development Programs
                       
Vernakalant (iv)
  $ 66     $ 974     $ 622     $ 4,217  
Vernakalant (oral)
    9       198       66       925  
    $ 75     $ 1,172     $ 688     $ 5,142  
Research Projects
                               
Other projects (including pre-clinical studies)
    374       2,731       4,944       6,640  
Total research and development expenditures
  $ 449     $ 3,903     $ 5,632     $ 11,782  

Research and development (“R&D”) expenditures were $0.5 million for Q3-2012 as compared to $3.9 million for Q3-2011. We incurred total R&D expenditures of $5.6 million for the nine months ended September 30, 2012, compared to $11.8 million for the same period in 2011. R&D expenditures consist of clinical development and research expenditures.
 
For the remainder of 2012, we expect our R&D expenditures to be significantly reduced as a result of the elimination of positions focused on internal research activities in Q3-2012.

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 Q3-2012 were $0.1 million as compared to $1.2 million for Q3-2011. For the nine months ended September 30, 2012 clinical development expenditures were $0.7 million as compared to $5.1 million for the same period in 2011. The decrease of $1.1 million and $4.4 million in expenditures for Q3-2012 and year-to-date, respectively, was primarily due to reduced costs for vernakalant (iv) as a result of the termination of the ACT 5 trial.
 
For the three and nine months ended September 30, 2012, we continued to incur costs in support of the vernakalant program.
 
For the remainder of 2012, we will continue to incur costs in support of the vernakalant program, including our portion of any development costs related to vernakalant (iv) in North America pursuant to our collaboration and license agreement with Merck.  With the anticipated return of the global rights to vernakalant, we expect clinical development expenditures to increase as transition activities begin.
 
 
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 Q3-2012 were $0.4 million as compared to $2.7 million for Q3-2011. For the nine months ended September 30, 2012 research expenditures were $4.9 million as compared to $6.6 million for the same period in 2011. The decrease of $2.3 million and $1.7 million in expenditures for Q3-2012 and year-to-date, respectively, were primarily due to the restructuring initiatives.
 
For the remainder of 2012, our costs related to the development of pre-clinical projects are expected to be lower than the previous quarters of the year.

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 Q3-2012 were $2.5 million as compared to $2.8 million for Q3-2011. On a year-to-date basis, we incurred total G&A expenditures of $7.3 million for the nine months ended September 30, 2012, compared to $9.4 million for the same period in 2011. The decrease in G&A expenditures is primarily due to a decrease in wages and benefits as a result of our workforce reductions in March and July 2012. The decrease in G&A expenditures was partially offset by an increase in stock-based compensation expense related to stock options granted to employees in Q3-2012.
 
For the remainder of 2012, we expect our G&A expenditures to decrease as a result of our restructuring efforts.

Restructuring
 
Restructuring consists of employee termination benefits, idle-use expense, asset impairments, and other charges.  
 
Restructuring charges for the three and nine months ended September 30, 2012 were $9.0 million and $10.0 million, respectively, related primarily to the workforce reductions in March and July of 2012 and the exit of redundant leased facilities in Q3-2012.
 
The restructuring activities were substantially completed in Q3-2012. For the remainder of 2012, we expect any additional restructuring charges to be minimal.  

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 Q3-2012 and Q3-2011 was $1.0 million and $0.5 million, respectively. For the nine months ended September 30, 2012 and 2011, other expense was $2.9 million and $1.1 million, respectively. The increase in other expense in 2012 is primarily due to the 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:
 
(In thousands of U.S. dollars
 
Quarter ended
 
except per share amounts)  
September 30,
2012
   
June 30,
2012
(Restated)(1)
   
March 31,
2012
(Restated)(1
   
December 31,
2011
 
                         
Total revenue
  $ 63     $ 209     $ 433     $ 401  
Research and development
    449       2,255       2,928       3,442  
General and administration
    2,496       2,207       2,552       2,095  
Restructuring
    9,036       165       804       -  
Net loss
  $ (13,412 )   $ (5,677 )   $ (6,970 )        $ (5,898 )     
Loss per share
                               
Basic and diluted
  $ (0.22 )   $ (0.09 )   $ (0.11 )          $ (0.10 )       
 
(In thousands of U.S. dollars
 
Quarter ended
 
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 loss
  $ (7,153 )   $ (7,723 )   $ (7,146 )   $ (7,302 )
Loss per share
                               
Basic and diluted
  $ (0.12 )     (0.13 )     (0.12 )     (0.12 )

(1)
Restatement relates to the reclassification to restructuring of employee termination benefits related to the Q1-2012 workforce reduction.

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

Research and Development Expenditures:
 
The timing of clinical trials and research work performed resulted in the variations in R&D expenditures with the exception of the most recent quarter.  The significant decrease in R&D expenditures in Q3-2012 is due to the elimination of the internal research function.


 
11

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

Restructuring:
 
The timing of the workforce reductions during the year and the idle-use expense in Q3-2012 resulted in the variations in restructuring cost.


LIQUIDITY AND CAPITAL RESOURCES

Our operational activities during Q3-2012 were financed mainly by working capital carried forward from the preceding fiscal year and advances under our credit facility with Merck.  Further advances under our credit facility with Merck are no longer available as a result of Merck’s notice of termination of our collaboration and license agreement. We believe that our cash position as of September 30, 2012 and the anticipated cash inflows from our collaborative partner 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 external research efforts, the development and commercialization of vernakalant, and operational and strategic activities.
 
At September 30, 2012, we had working capital of $47.8 million compared to $47.2 million at December 31, 2011. We had available cash reserves comprised of cash and cash equivalents of $53.6 million at September 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 September 30,
   
For the Nine Months
Ended September 30,
 
   
2012
   
2011
   
2012
   
2011
 
Cash used in operating activities
  $ (7,006 )   $ (6,402 )   $ (19,796 )   $ (21,702 )
Cash used in investing activities
    (89 )     (158 )     (314 )     (943 )
Cash provided by financing activities
    -       -       25,000       358  
Effect of foreign exchange rate on cash and cash equivalents
    40       (209 )     87       (54 )
Net increase (decrease) in cash and cash equivalents
  $ (7,055 )   $ (6,769 )   $ 4,977     $ (22,341 )

Cash used in operating activities in Q3-2012 was $7.0 million compared to $6.4 million in Q3-2011. The increase of $0.6 million in cash used was primarily due to timing of cash payments of trade payables. Cash used in operating activities for the nine months ended September 30, 2012 was $19.8 million, a decrease of $1.9 million from $21.7 million used in operating activities for the same period in 2011.
 
Cash used in investing activities was $0.1 million in Q3-2012 compared to $0.2 million in Q3-2011, and was $0.3 million and $0.9 million for the nine months ended September 30, 2012 and 2011, respectively. Cash used in investing activities related to the purchase of equipment and patent costs.
 
 
12

 
No cash was provided by financing activities in Q3-2012 and Q3-2011. On a year-to-date basis, cash provided by financing activities for the nine months ended September 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.

Contractual Obligations
 
As of September 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)
    1,158       4,596       4,596       4,596       4,609       2,298       21,853  
Operating lease obligations
    26       102       102       79                       309  
Other commitments
    13       4       2    
Nil
   
Nil
   
Nil
      19  
Total
  $ 1,197     $ 4,702     $ 4,700     $ 4,675     $ 29,609     $ 27,298     $ 72,181  

(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 September 30, 2012.

Outstanding Share Capital
 
As of November 8, 2012, there were 61,129,091 common shares issued and outstanding, and 5,109,887 common shares issuable upon the exercise of outstanding stock options (of which 3,830,243 were exercisable) at a weighted average exercise price of CAD $3.31 per share.

NASDAQ LISTING

On October 25, 2012, we announced the NASDAQ Listing Qualifications Staff(“Staff”) approved the Company’s request to transfer its listing from The NASDAQ Global Market to The NASDAQ Capital Market.  On October 31, 2012, we announced the Staff’s further approval of the company’s request for an additional 180 day period in which to regain compliance with the minimum $1.00 bid price per share requirement. 
 
The Staff’s determination to grant the additional 180 day compliance period was based on the Company meeting the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on the NASDAQ Capital Market, with the exception of the bid price requirement, and the Company’s written notice of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary.



 
13

 
RELATED PARTY TRANSACTIONS

Included in accounts payable and accrued liabilities as of September 30, 2012 was $0.2 million (December 31, 2011 - $0.1 million) owing to a law firm in which 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 $0.8 million for the nine months ended September 30, 2012 (2011 - $0.6 million) of legal fees for services provided by this law firm.  Subsequent to the quarter-end, the related party resigned as corporate secretary.   


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.


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, 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 September 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)
 
   
September 30,
2012
   
December 31,
2011
 
             
Assets
           
             
Current assets:
           
Cash and cash equivalents
  $ 53,621     $ 48,644  
Accounts receivable
    700       1,248  
Prepaid expenses and other assets
    675       628  
      54,996       50,520  
                 
Property and equipment
    430       1,967  
Intangible assets
    1,501       1,548  
    $ 56,927     $ 54,035  
                 
Liabilities and Stockholders’ Equity
               
                 
Current liabilities:
               
Accounts payable and accrued liabilities (note 5)
  $ 7,235     $ 3,188  
Current portion of deferred leasehold inducement
    -       116  
      7,235       3,304  
                 
Deferred leasehold inducement
    -       445  
Long-term debt (note 6)
    50,000       25,000  
      57,235       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
    32,673       32,208  
Deficit
    (313,263 )     (287,204 )
Accumulated other comprehensive income
    18,185       18,185  
      (308 )     25,286  
    $ 56,927     $ 54,035  
 
 
Related party transactions (note 9)

 
Contingencies (note 10)
 
 
See accompanying notes to the consolidated financial statements.
 
 
2

 
 
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
   
Nine months ended
 
   
September 30,
2012
   
September 30,
2011
   
September 30,
2012
   
September 30,
2011
 
Revenue:
                       
Licensing and other fees
  $ 60     $ 91     $ 379     $ 372  
Research collaborative fees
    3       183       326       732  
      63       274       705       1,104  
Expenses:
                               
Research and development
    449       3,903       5,632       11,782  
General and administration
    2,496       2,764       7,255       9,454  
Restructuring (note 8)
    9,036       -       10,005       -  
Amortization
    507       271       980       825  
      12,488       6,938       23,872       22,061  
Operating loss
    (12,425 )     (6,664 )     (23,167 )     (20,957 )
                                 
Other expenses (income):
                               
Interest expense
    1,154       560       3,383       1,659  
Other income
    (181 )     (234 )     (489 )     (626 )
Foreign exchange loss (gain)
    14       163       (2 )     32  
      987       489       2,892       1,065  
Net loss and comprehensive loss for the period
  $ (13,412 )   $ (7,153 )   $ (26,059 )   $ (22,022 )
Basic and diluted loss per common share(1)
  $ (0.22 )   $ (0.12 )   $ (0.43 )   $ (0.36 )
Weighted average common shares outstanding
    61,129,091       61,129,091       61,129,091       61,124,696  
 
 
(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.
 
 
3

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

 
 
 
For the nine months ended September 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
    -       -       (26,059 )     -       (26,059 )
Stock-based compensation expense recognized
    -       465       -       -       465  
Balance at September 30, 2012
  $ 262,097     $ 32,673     $ (313,263 )      $ 18,185     $ (308 )   
 
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-based compensation expense recognized
    -       1,657       -       -       1,657  
Balance at September 30, 2011
  $ 262,097     $ 31,934     $ (281,306 )   $ 18,185     $ 30,910  
 
See accompanying notes to the consolidated financial statements.
 
 
4

 
 
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,
2012
   
September 30,
2011
   
September 30,
2012
   
September 30,
2011
 
Cash flows from operating activities:
                       
Net loss for the period
  $ (13,412 )   $ (7,153 )   $ (26,059 )   $ (22,022 )
Items not affecting cash:
                               
Amortization
    507       271       980       825  
Stock-based compensation
    160       636       465       1,657  
Deferred leasehold inducement
    (504 )     (44 )     (561 )     (115 )
Unrealized foreign exchange loss (gain)
    (38 )     80       (77 )     (21 )
Impairment of property and equipment
    711       -       716       -  
Changes in operating assets and liabilities:
                               
Accounts receivable
    809       642       551       128  
Prepaid expenses and other assets
    (84 )     (150 )     153       319  
Accounts payable and accrued liabilities
    4,845       (684 )     4,036       (2,473 )
Net cash used in operating activities
    (7,006 )     (6,402 )     (19,796 )     (21,702 )
                                 
Cash flows from investing activities:
                               
Purchase of property and equipment
    (21 )     (101 )     (111 )     (634 )
Purchase of intangible assets
    (68 )     (57 )     (203 )     (309 )
Net cash used in investing activities
    (89 )     (158 )     (314 )     (943 )
                                 
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
    40       (209 )     87       (54 )
Increase (decrease) in cash and cash equivalents during the period
    (7,055 )     (6,769 )     4,977       (22,341 )
Cash and cash equivalents, beginning of period
    60,676       61,316       48,644       76,888  
Cash and cash equivalents, end of period
  $ 53,621     $ 54,547     $ 53,621     $ 54,547  
                                 
Supplemental cash flow information:
                               
Interest paid
  $ 1     $ 567     $ 2,238     $ 1,677  
Interest received
    6       7       13       18  
 
 
See accompanying notes to the consolidated financial statements.
 
 
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, 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 nine month periods ended September 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 that was 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. It may be necessary for the Company to raise additional funds for the continuing development of its technologies. These funds may come from sources which include, entering into strategic collaboration agreements, issuance of shares, or alternative sources of financing. However, there can be no assurance that the Company will successfully raise funds to continue the development of its technologies.
 
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.
 
 
6

 
 
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, 2012 and 2011


2.Changes in significant accounting policies (continued):   
   
 (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.
 
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 September 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.Impairment of long-lived assets:
 
The Company reviews long-lived depreciable assets for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. The Company determines whether the carrying value of a long-lived depreciable asset or asset group is recoverable based on its estimates of future asset utilization and undiscounted expected future cash flows the assets are expected to generate. If the total of the expected undiscounted future cash flows is less than the carrying amount of the asset, a loss is recognized for the excess of the carrying amount over the fair value of the asset. The Company primarily uses the income approach when determining the fair value of assets.
 
On July 9, 2012, the Company reduced its workforce by eliminating positions focused on internal research activities along with certain supporting functions (note 8). As a result, the Company has exited redundant leased facilities and has determined the impairment of associated leasehold improvements.  The Company also determined the carrying amounts of certain computer and office equipment were not recoverable. During the three months ended September 30, 2012, total impairment charges recorded as part of restructuring expenses were $711.
 
 
7

 
 
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, 2012 and 2011

5.Accounts payable and accrued liabilities:
 
Accounts payable and accrued liabilities comprise:
 
             
   
September 30,
   
December,31
 
   
2012
   
2011
 
             
Trade accounts payable
  $ 1,605     $ 743  
Accrued contract research
    353       1,066  
Employee-related accruals
    59       746  
Restructuring (note 8)
    4,607       -  
Other accrued liabilities (1)
    611       633  
                 
    $ 7,235     $ 3,188  
 
(1)  
Included in other accrued liabilities at September 30, 2012 is an amount of $218 (December 31, 2011 - $59) owing to a related party (note 9).

 
6.Long term debt:  
 
Pursuant to a collaboration and license agreement (Agreement) with Merck Sharp & Dohme (Switzerland) GmbH and Merck Sharp & Dohme Corp. (formerly Merck & Co., Inc.) (Merck), Merck 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 could 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.
 
The Company borrowed $25 million under this facility during the nine months ended September 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.
 
On September 25, 2012, Merck gave notice to the Company of its termination of the Agreement (note 7). As a result of the notice of termination, Merck does not have an obligation to make further advances under the credit facility.  Terms of the existing advances made under the credit facility prior to the notice of termination of the Agreement remain the same.
 
 
8

 
 
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, 2012 and 2011


7.Collaborative agreements:  
 
Pursuant to two collaboration and license agreements with Merck, the Company granted Merck exclusive global rights for the development and commercialization of vernakalant (iv) and vernakalant (oral).
 
On March 19, 2012, the Company announced Merck’s decision to discontinue further development of vernakalant (oral).
 
On September 25, 2012, Merck gave notice to the Company of its termination of both collaboration and license agreements.  The terminations will be effective after the notice periods pursuant to the terms of the collaboration and license agreements.  Upon the effective dates of the terminations, the Company will have exclusive global rights to vernakalant (iv) and vernakalant (oral).

8.Restructuring:  
 
On March 19, 2012, the Company reduced its workforce in response to Merck’s decision to discontinue further development of vernakalant (oral). On July 9, 2012, the Company further reduced its workforce by eliminating positions focused on internal research activities along with certain supporting functions.
 
The Company estimated costs relating to employee severance and benefit arrangements to total $5,621. For the nine months ended September 30, 2012, the Company recognized employee termination benefit charges of $5,530.  These charges were primarily for employee severance packages and outplacement support and included a net reversal of $273 of stock-based compensation relating to forfeiture of unvested options by terminated employees. Of these charges, $654 accrued at September 30, 2012 is expected to be paid by the end of the first quarter of 2013.
 
As a result of the workforce reductions, the Company exited certain redundant leased facilities and terminated certain contracts.  Idle-use expense and other charges recognized in the third quarter of 2012 were $3,764. These charges included $80 of non-cash items, and were partially offset by the immediate recognition of $473 of deferred leasehold inducement. Total idle-use expense and other charges of $3,953 accrued at September 30, 2012 are expected to be paid by the end of 2012.
 
Total asset impairment charges of $711 recorded in the third quarter of 2012 relate to leasehold improvements and certain computer and office equipment impaired as a result of the workforce reductions (note 4).
 
 
9

 
 
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, 2012 and 2011


8.Restructuring (continued):  
 
The following table summarizes the provisions related to the restructuring for the nine months ended September 30, 2012:

   
Employee
termination
benefits
   
Idle-use
expense
and other
charges
   
Asset
impairments
   
Total
 
                         
Restructuring expense recognized
    5,530       3,764       711       10,005  
Payments made
    (5,158 )     (201 )     -       (5,359 )
Non-cash items
    273       393       (711 )     (45 )
Foreign exchange adjustment
    9       (3 )     -       6  
Total restructuring accrual as of September 30, 2012
    654       3,953       -       4,607  
 
9.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, 2012, the Company has incurred legal fees of $751 (September 30, 2011 - $619) for services provided by the law firm relating to general corporate matters. Included in accounts payable and accrued liabilities at September 30, 2012 is an amount of $218 (December 31, 2011 - $59) owing to the law firm.  Subsequent to the quarter-end, the related party resigned as an officer of the Company.
 
10.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

 
10

 
 
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, 2012 and 2011


10.Contingencies (continued):
 
 
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 and is currently in discussions to resolve this proceeding.

 
 
11

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
November 13, 2012

3.  
News Release
November 13, 2012 - Vancouver, Canada

4.  
Summary of Material Change
Cardiome Pharma Corp. reported financial results for the third quarter ended September 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:                    Ms. Jennifer Archibald
Title:                      Chief Financial Officer
Phone No.:            604-677-6905

9.  
Date of Report
November 13, 2012



Per:        Jennifer Archibald”
Jennifer Archibald,
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 September 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 July 1, 2012 and ended on September 30, 2012 that has materially affected, or is reasonably likely to materially affect, the issuer’s ICFR.


Date: November 13, 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, Jennifer Archibald, 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, 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 July 1, 2012 and ended on September 30, 2012 that has materially affected, or is reasonably likely to materially affect, the issuer’s ICFR.


Date: November 13, 2012

Jennifer Archibald
Jennifer Archibald
Chief Financial Officer