-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, SWu23YXOtgbFIKadNffUlrI3txsK1gUM5RfpCmKqK+i5xfjqyqwVmkOw5jiAcGiC hJAD1+SI2vf0CTalFpDMHw== 0001062993-05-002139.txt : 20050908 0001062993-05-002139.hdr.sgml : 20050908 20050908154419 ACCESSION NUMBER: 0001062993-05-002139 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 18 CONFORMED PERIOD OF REPORT: 20050601 FILED AS OF DATE: 20050908 DATE AS OF CHANGE: 20050908 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: 1130 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-29338 FILM NUMBER: 051075309 BUSINESS ADDRESS: STREET 1: 6190 AGRONOMY RD. 6TH FLOOR CITY: VANCOUVER STATE: A1 ZIP: V6T 1Z3 BUSINESS PHONE: 1-604-677-6905 MAIL ADDRESS: STREET 1: 6190 AGRONOMY RD. 6TH FLOOR CITY: VANCOUVER STATE: A1 ZIP: V6T 1Z3 FORMER COMPANY: FORMER CONFORMED NAME: CARDIOME PHARMA CORP DATE OF NAME CHANGE: 20000407 6-K 1 form6k.htm REPORT OF FOREIGN ISSUER Filed by Automated Filing Services Inc. (604) 609-0244 - Cardiome Pharma Corp. - Form 6-K

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

Report of Foreign Issuer

Pursuant to Rule 13a-16 or 15d-16 of

The Securities Exchange Act of 1934

For June 1, 2005– September 2, 2005

CARDIOME PHARMA CORP.

(Translation of Registrant’s name into English)

6190 Agronomy Road, 6th Floor
(Address of principal executive offices)

Vancouver, British Columbia, V6T 1Z3, CANADA

CIK # 0001036141 FILE NO. 0-29338

[Indicate by check mark whether the registrant files or will file annual reports under cover
Form 20-F or For 40-F]

Form 20-F    ¨                 Form 40-F     x

[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     x                               No     ¨


FORM 6-K
TABLE OF CONTENTS

For June 1, 2005 – September 2, 2005

CARDIOME PHARMA CORP.
(formerly NORTRAN PHARMACEUTICALS INC.)

File No. 0-29338, CIK # 0001036141

Exhibit 99-1 Press Release – July 21, 2005 (Cardiome Completes ACT 3 Enrolment)
   
Exhibit 99-2 Material Change Report - Cardiome Completes ACT 3 Enrolment
   
Exhibit 99-3 Press Release – August 11, 2005 (Cardiome Reports Second Quarter Results)
   
Exhibit 99-4 Material Change Report - Cardiome Reports Second Quarter Results
   
Exhibit 99-5 Interim Financial Statements for the Quarter Ended June 30, 2005
   
Exhibit 99-6 Certification of Filings – CFO
   
Exhibit 99-7 Certification of Filings – CEO
   
Exhibit 99-8 Confirmation of Mailing
   
Exhibit 99-9 Press Release – August 15, 2005 (Cardiome Reports Clinical Results From OPT-CHF Study)
   
Exhibit 99-10 Material Change Report - Cardiome Reports Clinical Results From OPT-CHF Study
   
Exhibit 99-11 Press Release – August 29, 2005 (Cardiome Announces Letter of Intent to Acquire Artesian Therapeutics)
   
Exhibit 99-12 Material Change Report - Cardiome Announces Letter of Intent to Acquire Artesian Therapeutics
   
Exhibit 99-13 Press Release – August 31, 2005 (Cardiome Successfully Completes RSD1235 Oral Phase 1 Trial)
   
Exhibit 99-14 Material Change Report - Cardiome Successfully Completes RSD1235 Oral Phase 1 Trial
 

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 of the undersigned, thereunto duly authorized.

  CARDIOME PHARMA CORP.    
    (REGISTRANT)
     
     
Date: September 6, 2005    
     
     
     
     
     Christina Yip
          Vice President, Finance and Admin


EX-99.1 2 exhibit99-1.htm PRESS RELEASE DATED JULY 21, 2005 Filed by Automated Filing Services Inc. (604)609-0244 - Cardiome Pharma Corp. - Exhibit 99.

6190 Agronomy Rd.
6th Floor
Vancouver, BC
V6T 1Z3 CANADA

Tel: 604-677-6905
Fax: 604-677-6915
Website: www.cardiome.com

FOR IMMEDIATE RELEASE        NASDAQ: CRME TSX: COM

CARDIOME COMPLETES ACT 3 ENROLMENT

Vancouver, Canada, July 21, 2005 Cardiome Pharma Corp (NASDAQ: CRME) (TSX: COM) today announced that it has completed patient enrolment in its second pivotal Phase 3 atrial fibrillation trial, ACT 3. The study is being conducted by co-development partner Astellas Pharma US, Inc. (formed on April 1, 2005 by the merger of Fujisawa Pharmaceutical Co., Ltd. and Yamanouchi Pharmaceutical Co., Ltd.). The study will evaluate the safety and efficacy of intravenous RSD1235 in 276 patients with atrial arrhythmia. The multinational placebo-controlled study is being conducted at more than 50 centers.

“We are pleased to complete another milestone in the advancement of our RSD1235 IV product candidate.” stated Bob Rieder, President and CEO of Cardiome. “Our co-development partner Astellas can now proceed with analysis of the data and inclusion of ACT 3 as part of the NDA submission. We expect top-line results from the study to be released in the 3rd quarter of 2005.”

The primary efficacy endpoint of the ACT 3 trial is acute conversion of atrial fibrillation to normal heart rhythm in recent-onset atrial fibrillation patients. The study also includes analysis of patients with longer-term atrial fibrillation and patients with atrial flutter. Safety observations focus on sensory and cardiovascular effects of the drug, with particular emphasis on lack of side-effect arrhythmias.

“The completed study reflects two relevant changes to the original protocol.” stated Charles Fisher M.D., Cardiome’s Executive Vice President and Chief Medical Officer. “First, the evaluation of the data will now separate atrial fibrillation patients from atrial flutter patients, in order to make the ACT 3 study data more comparable to the ACT 1 study data. Second, 276 patients were enrolled rather than the originally-projected 240 patients.”

ACT 3 is one of three Phase 3 studies Cardiome and Astellas are conducting for intravenous RSD1235 applied to the treatment of atrial arrhythmia. The NDA application will be based primarily on data from the ACT 1 and ACT 3 studies. The ACT 2 study, evaluating patients with post-operative atrial arrhythmia, is ongoing.

In October 2003, Cardiome licensed North American rights to the intravenous formulation of RSD1235 to Astellas Pharma US, Inc. (then Fujisawa Healthcare Inc.). Under the terms of the agreement Cardiome granted Astellas an exclusive license to develop and commercialize RSD1235 IV in North America. The companies will co-develop RSD1235 IV to NDA, with Astellas responsible for 75% of development costs. Cardiome has retained all rights to the intravenous formulations outside of Canada, U.S. and Mexico, and has also retained worldwide rights to oral RSD1235 for the prevention of AF.

Atrial fibrillation is an abnormal heart rhythm that affects the atria of the heart, lowering the heart’s pumping capacity. Immediate symptoms are breathlessness and fatigue. Long-term effects include increased risk of both stroke and congestive heart failure. In 2002, there were over 7 million cases of atrial arrhythmia in the developed world.


About Cardiome Pharma Corp.

Cardiome Pharma Corp. is a product-focused cardiovascular drug development company with three clinical drug programs, two of which focus on atrial arrhythmia (intravenous and oral dosing) and one directed at congestive heart failure.

RSD1235 IV is the intravenous formulation of an investigational drug being evaluated for the acute treatment of recent-onset atrial fibrillation (AF). RSD1235 also has a potential application as a chronic-use oral drug for the maintenance of normal heart rhythm following termination of AF.

Cardiome's lead drug in the congestive heart failure (CHF) area is oxypurinol, a xanthine oxidase inhibitor. CHF is the failure of the heart to pump blood at a rate sufficient to support the body's needs. A Phase 2 clinical trial that evaluates the safety and effectiveness of oxypurinol in the treatment of patients with moderate to severe symptomatic CHF has been completed. Results from this study are expected in Q3/05.

Cardiome is traded on the Toronto Stock Exchange (COM) and the NASDAQ National Market (CRME). Further information about Cardiome can be found at www.cardiome.com.

For Further Information:
Don Graham
Director of Corporate Communication
(604) 676-6963 or Toll Free: 1-800-330-9928
Email: dgraham@cardiome.com

Peter K. Hofman
Director, Investor Relations
(604) 676-6993 or Toll Free: 1-800-330-9928
Email: phofman@cardiome.com

Forward-Looking Statement Disclaimer
Statements contained in this news release relating to future results, events and expectation are forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievement of the company, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such statements. Such factors include, among others, those described in the Company's annual report on Form 40-F. The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this release.


EX-99.2 3 exhibit99-2.htm MATERIAL CHANGE REPORT DATED JULY 21, 2005 Filed by Automated Filing Services Inc. (604)609-0244 - Cardiome Pharma Corp. - Exhibit 99.2

FORM 53-901F

SECURITIES ACT

MATERIAL CHANGE REPORT UNDER
SECTION 85(1) OF THE SECURITIES ACT (BRITISH COLUMBIA)
AND EQUIVALENT LEGISLATION OF OTHER JURISDICTIONS

Item 1.
REPORTING ISSUER
 
Cardiome Pharma Corp.
6190 Agronomy Road, 6th Floor
Vancouver, BC V6T 1Z3
 
Item 2.
DATE OF MATERIAL CHANGE
 
July 21, 2005
 
Item 3.
PRESS RELEASE
 
July 21, 2005 – Vancouver, British Columbia
 
Item 4.
SUMMARY OF MATERIAL CHANGE
 
Cardiome Pharma Corp announced that it has completed patient enrolment in its second pivotal Phase 3 atrial fibrillation trial, ACT 3. The study is being conducted by co-development partner Astellas Pharma US, Inc. (formed on April 1, 2005 by the merger of Fujisawa Pharmaceutical Co., Ltd. and Yamanouchi Pharmaceutical Co., Ltd.). The study will evaluate the safety and efficacy of intravenous RSD1235 in 276 patients with atrial arrhythmia. The multinational placebo-controlled study is being conducted at more than 50 centers.
 
Item 5.
FULL DESCRIPTION OF MATERIAL CHANGE
 
See attached press release.
 
Item 6.
RELIANCE ON SECTION 85(2) OF THE SECURITIES ACT (BRITISH COLUMBIA) AND EQUIVALENT LEGISLATION OF OTHER JURISDICTIONS
 
Not Applicable.
 
Item 7.
OMITTED INFORMATION
 
Not Applicable.
 
Item 8.
SENIOR OFFICER
 
Name:                    Christina Yip
Title:                      Vice President, Finance and Administration
Phone No.:            604-677-6905
 
Item 9.
STATEMENT OF SENIOR OFFICER
 
The foregoing accurately discloses the material change referred to herein.


Dated at Vancouver, British Columbia, this 21st day of July, 2005.

  CARDIOME PHARMA CORP.
     
  Per:  
   
   

Christina Yip,
Vice President, Finance and Administration

IT IS AN OFFENCE FOR A PERSON TO MAKE A STATEMENT IN A DOCUMENT REQUIRED TO BE FILED OR FURNISHED UNDER THE ACT OR THIS REGULATION THAT, AT THE TIME AND IN THE LIGHT OF THE CIRCUMSTANCES UNDER WHICH IT IS MADE, IS A MISREPRESENTATION.


EX-99.3 4 exhibit99-3.htm PRESS RELEASE DATED AUGUST 11, 2005 Filed by Automated Filing Services Inc. (604)609-0244 - Cardiome Pharma Corp. - Exhibit 99.3

6190 Agronomy Rd.
6th Floor
Vancouver, BC
V6T 1Z3 CANADA

Tel: 604-677-6905
Fax: 604-677-6915
Website: www.cardiome.com

FOR IMMEDIATE RELEASE        NASDAQ: CRME TSX: COM

CARDIOME REPORTS SECOND QUARTER RESULTS

Vancouver, Canada, August 11, 2005 -- Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) reported today financial results for the second quarter ended June 30, 2005. Amounts, unless specified otherwise, are in Canadian dollars. At close of business on June 30, 2005, the exchange rate was CDN$1.00 = U.S. $0.8161.

Corporate Development
The following are significant events which occurred since our last quarterly report:

  • We have been selected to become a member of the NASDAQ Biotechnology Index(R). Our inclusion in the index became effective on May 23, 2005.
     
  • We completed patient enrolment in our second pivotal Phase 3 atrial fibrillation trial, ACT 3, in July 2005. The study is being conducted by our co-development partner, Astellas. The study will evaluate the safety and efficacy of intravenous RSD1235 in 276 patients with atrial arrhythmia.

Results of Operations
For the three months ended June 30, 2005 (“Q2-2005”), we recorded a net loss of $7.7 million ($0.15 per common share), compared to a net loss of $9.8 million ($0.25 per common share) for the three months ended June 30, 2004 in the preceding fiscal year (“Q2-2004”). On a year-to-date basis, we recorded a net loss of $15.3 million ($0.33 per common share) for the six months ended June 30, 2005, compared to a net loss of $14.6 million ($0.38 per common share) for the six months ended June 30, 2004.

The decline in net loss by $2.1 million in Q2-2005, as compared to the net loss in Q2-2004, was due to a decline in total operational expenditures by $0.9 million, an increase in other income by $1.0 million, and an increase future income tax recovery by $1.7 million; these were offset by a decline in total revenue by $1.5 million. The increase of net loss by $0.7 million for the six months ended June 30, 2005, as compared to the same period in fiscal 2004, was due to a decline in total revenue by $1.9 million and an increase in total operational expenditures by $3.1 million; these were offset by an increase in other income by $1.3 million, and an increase in future income tax recovery by $3.0 million. These results of operations were in line with our expectations.

We expect losses to continue for at least the next two fiscal years as we advance RSD1235 (oral) and oxypurinol CHF into later stage development. These chronic treatment product candidates will require substantial funding in Phase II and Phase III clinical development. As such, we expect our operating expenses for these product candidates to be higher than the potential licensing and research collaborative fees or royalty revenue from RSD1235 (iv), should we successfully meet our collaborative milestones or obtain commercialization approval for RSD1235 (iv) within this period.

Revenues
Total revenue for Q2-2005 declined to $3.8 million from $5.3 million for Q2-2004. On a year to date basis, total revenue for the six months ended June 30, 2005 was $8.4 million as compared to $10.3 million for the same period in fiscal 2004. Total revenue comprised licensing fees and research collaborative fees we collected from our collaborative partners as described below.


Licensing fees represent the amortization of deferred revenue related to upfront payments and premium on equity investment from our collaborative partners. We recorded $1.2 million of licensing fees for Q2-2005 as compared to $1.1 million for Q2-2004, and $2.4 million for the six months ended June 30, 2005, as compared to $3.1 million for the same period in fiscal 2004. The current quarter increase was largely due to the amortization of deferred revenue of $0.1 million ($Nil for Q2-2004) associated with the additional deferred revenue relating to the premium on equity investment from Astellas. The decrease of $0.7 million of licensing fees on a year-to-date basis, as compared to the same six month period in fiscal 2004, was primarily due to the recognition of the remaining $0.9 million of unamortized deferred revenue related to the upfront payment from our former collaborative partner, UCB Farchim S.A, or UCB. This was offset by the amortization of deferred revenue of $0.2 million ($Nil for the six months ended June 30, 2004) associated with the additional deferred revenue relating to the premium on equity investment from Astellas.

Research and collaborative fees are composed of project management fees and contract research fees we charged collaborative partners for our work and the associated out of pocket expenses we recovered from them. Research collaborative fees were $2.6 million for Q2-2005, as compared to $4.2 million for Q2-2004, and $6.0 million for the six months ended June 30, 2005, as compared to $7.2 million for the same period in fiscal 2004. The decrease for both periods was primarily due to the reduced research and development collaborative fees from Astellas. Out of pocket expenses associated with RSD1235 (iv) operational activities that we directly incurred have reduced by $1.9 million in Q2-2005 as compared to Q2-2004, and $1.6 million for the six month period ended June 30, 2005, as compared to the same period in fiscal 2004, due to the completion of ACT 1 in early 2005. This was offset by an increase of $0.3 million and $0.4 million in project management fees and contract research fees for Q2-2005 and for the six months ended June 30, 2005, respectively, as compared to the same periods in fiscal 2004. Included in these fees in fiscal 2004 was a $0.2 million contract research fee from our former collaborative partner, UCB Farchim S.A. which was terminated in March 2004.

For the remainder of the current fiscal year, we expect to continue recognizing as revenue the amortization of deferred revenue related to the upfront payment and the premium on equity investment from Astellas. We will also continue to receive project management fees and development cost reimbursements from Astellas.

Research and Development Expenditures
Research and development expenditures were $11.9 million for Q2-2005, as compared to $12.4 million for Q2-2004. We incurred total research and development expenditures of $23.4 million for the six months ended June 30, 2005, as compared to $20.0 million for same period in fiscal 2004.

Research and development expenditures for Q2-2005 were comparable to the amount recorded for Q2-2004. The increase of $3.4 million in research and development expenditures for the six months ended June 30, 2005, as compared to those incurred for the six months ended June 30, 2004, was primarily due to the expanded clinical development activities during the six months ended June 30, 2005, with continuation or completion of three Phase III studies of RSD1235 (iv) [ACT 1, ACT 2 and ACT 3], one Phase II regulatory study [OPT-CHF], two Phase II proof-of-concept studies [Exotic-EF and LaPlata] of Oxypurinol, and two Phase I studies of RSD1235 (oral).

We expect our research and development expenditures for the current fiscal year to be higher than those incurred in fiscal 2004. The majority of the increase will be associated with our RSD1235 (iv) and RSD1235 (oral) projects.

The following provides a description of major clinical trial(s) and research and development expenditure for each of our projects:


RSD1235 (iv)
During Q2-2005, we continued our work on two additional Phase III clinical trials, ACT 2 and ACT 3.

The ACT 1 Study
The study looked at three sub-groups of patients, including 237 patients with recent-onset atrial fibrillation (more than three hours but less than seven days), 119 patients with longer-term atrial fibrillation (more than seven days but less than 45 days) and 60 patients with atrial flutter. The primary endpoint in ACT 1 was conversion of recent-onset atrial fibrillation to normal heart rhythm for a period of at least one minute post-dosing within 90 minutes of the start of dosing. The study was carried out in 45 centers in the U.S., Canada and Scandinavia. We completed enrollment in ACT 1 in October 2004 and announced that the study achieved its primary endpoints in December 2004. Additional clinical results of this study were released in February 2005 and a full trial report was presented in May 2005 at the Late Breaking Clinical Results section of the Heart Rhythm Society Meeting in New Orleans.

The ACT 2 Study
The ACT 2 study, initiated in March 2004, will enroll approximately 210 patients and will evaluate the efficacy and safety of RSD1235 (iv) in the treatment of patients who have developed transient atrial fibrillation following cardiac surgery. The primary endpoint in this study is acute conversion of atrial fibrillation to normal heart rhythm.

The ACT 3 Study
Our collaborative partner, Astellas, initiated the ACT 3 study in July 2004 and completed patient recruitment for this study in July 2005. ACT 3 enrolled 276 patients. The primary efficacy endpoint of the ACT 3 trial is acute conversion of atrial fibrillation to normal heart rhythm in recent-onset atrial fibrillation patients. The study also includes analysis of patients with longer-term atrial fibrillation and patients with atrial flutter. Safety observations focus on sensory and cardiovascular effects of the drug, with particular emphasis on lack of side-effect arrhythmias. We expect to announce top-line results in the 3rd quarter of 2005.

Total research and development expenditures for this project were $4.3 million for Q2-2005, as compared to $7.1 million for Q2-2004. On the year-to-date basis, our expenditures for this project were $11.2 million for the six months ended June 30, 2005, as compared to $11.8 million for the six months ended June 30, 2004. Also included in the expenditures were the costs associated with the manufacturing of stability batches of RSD1235 and clinical drug supplies. These stability batches will generate manufacturing data required for our potential NDA in later 2005 or early 2006.

We expect our research and development expenditures for this project to be higher for the current fiscal year than those incurred in fiscal 2004. The anticipated cost will relate to the final data analysis for ACT 1, ongoing ACT 2 study, completion of ACT 3 and preparation of the NDA.

RSD1235 (oral)
In September 2004, we initiated dosing of RSD1235 (oral) in 12 healthy volunteers in a Phase I formulation evaluation study in Europe. This study was an open-label, cross-over evaluation of two sustained release formulations of RSD1235 (oral) in comparison to an immediate release formulation of RSD1235 (oral). Based on the successful completion of the study in November 2004, we have chosen a controlled release formulation for further clinical development.

In November 2004, we initiated a food effect study. The objective of the study was to further evaluate the effect of food on the absorption of our controlled release formulation of RSD1235 in patients under both fed and fasted conditions. Based on the successful completion of the study in April 2005, the results confirmed that RSD1235 absorption is not significantly affected by food, suggesting that dosing need not be restricted according to meal time.


Total research and development expenditures for this project were $3.3 million for Q2-2005, as compared to $1.6 million for Q2-2004. On the year-to-date basis, our expenditures for this project were $4.9 million for the six months ended June 30, 2005, as compared to $2.2 million for the same period in fiscal 2004. The increase was the result of the increased operational activities associated with the series of Phase I clinical trials ongoing, manufacture of drug supplies, and pre-clinical toxicology testing work.

We expect our research and development expenditures for this project to be higher for the current fiscal year than those incurred in fiscal 2004 as we advance this project into Phase II clinical testing this year.

Oxypurinol for Congestive Heart Failure Project
During Q2-2005, we continued our work on the OPT-CHF study.

The OPT-CHF Study
OPT-CHF, which was initiated in March 2003, finished its patient recruitment in December 2004. The placebo-controlled study investigates the impact of 24 weeks of daily oral dosing of Oxypurinol (600 mg/day) on the clinical outcomes of an expected 404 moderate to severe symptomatic heart failure patients.

The study enrolled New York Heart Association class III and IV patients with ejection fractions less than or equal to 40%. All randomized patients had experienced at least one hospitalization or emergency room visit for heart failure in the previous 18 months, or had a new heart failure medication added to their drug regimen due to lack of medical stability.

The primary end point of the study is a composite that assigns all patients to one of three categories: improved, unchanged or worsened. Improvement consists of improvement in New York Heart Association class or improvement in patient global heart failure assessment. Worsening includes death, re-hospitalization or emergency clinic visit, requirement for acute change in medication, and other factors. We have completed patient recruitment and expect to report the results in the third quarter of 2005. If successful, we may initiate a Phase III clinical trial in 2006.

The EXOTIC-EF Study
In April 2005, we announced positive final results for an investigator-sponsored study, EXOTIC-EF. This open-label study, which was conducted in Europe, evaluated intravenous dosing of Oxypurinol in 20 catheterized congestive heart failure patients. The endpoints of this study were left-ventricle ejection fraction and cardiac oxygen consumption. The reported data covered all 18 patients who met the prospectively-defined entry criteria.

The LaPlata Study
This investigator-sponsored randomized, double-blinded, placebo controlled trial involved 28 days of oral dosing of Oxypurinol in Congestive Heart Failure patients with left-ventricle ejection fraction equal to or less than 40% and class II-III congestive heart failure as rated by the New York Heart Association classification system. The trial enrolled a total of 60 patients, of whom 47 met the entry criteria. The remaining 13 patients enrolled had left ventricle ejection fractions exceeding 40%, as measured by blinded reading of echocardiograms upon completion of the study. Final results were announced in February 2005. This study showed a statistically-significant improvement in an important measurement of cardiac function, the left ventricle ejection fraction. Improvement in the exercise tolerance (6 minute walk test) was seen in both treatment groups; however, no statistically significant difference between the two groups was observed.

As expected, with multiple clinical trials ongoing, our expenditures for this project increased substantially. Research and development expenditures for this project were $4.2 million for Q2-2005 as compared to $1.9 million for Q2-2004, and $7.1 million for the six months ended June 30, 2005 as compared to $3.5 million for the same period in fiscal 2004.


We expect our research and development expenditures for this project for the current fiscal year to be comparable to those incurred in fiscal 2004 as we complete all of the above studies, including the 404-patient OPT-CHF study, this year.

Other Non-core Projects
Following our decision to stop pursuing the allopurinol intolerant gout indication for Oxypurinol in 2004, research and development expenditures for the Oxypurinol gout project decreased substantially to $0.1 million for Q2-2005 as compared to $1.4 million for Q2-2004, and $0.2 million for the six months ended June 30, 2005 as compared to $2.0 million for the same period in fiscal 2004. The expenditures incurred for Q2-2005 and the six months ended June 30, 2005 were associated with our Compassionate Use Program for allopurinol intolerant gout patients. Expenditures associated with other experimental research declined to $Nil for the six months ended June 30, 2005 from $0.5 million for the six months ended June 30, 2004.

General and Administration Expenditures
General and administration expenditures for Q2-2005 were $2.2 million, which was comparable to the amount recorded for Q2-2004. On a year to date basis, we incurred a total general and administration expenditure of $4.1 million for the six months ended June 30, 2005, as compared to $3.7 million for the same period in fiscal 2004. The increase of $0.4 million for the six months ended June 30, 2005, as compared to those incurred for the six months ended June 30, 2004, was largely attributable to the increase of $648,000 in business development expenditures associated with out-licensing and in-licensing activities. This was offset by the decrease of $118,000 and $109,000 in consulting and professional fees and wages and benefits, respectively.

For the current fiscal year, we expect our general and administration expenditures to be comparable to those incurred in fiscal 2004.

Amortization
Amortization was $1.1 million for Q2-2005 as compared to $1.5 million for Q2-2004, and $2.2 million for the six months ended June 30, 2005 as compared to $2.9 million the same period in fiscal 2004. The decrease in amortization for both periods was attributable to the reduced amortization related to our intangible and other assets following the write-down of intangible assets associated with the Oxypurinol gout project in September 2004.

Other Income (Expenses)
Interest and other income was $0.5 million for Q2-2005 as compared to $0.3 million for Q2-2004, and $0.6 million for the six months ended June 30, 2005 as compared to $0.4 million for the same period in fiscal 2004. The increase in interest and other income for both periods was primarily the result of higher balances of cash and cash equivalents and short-term investments in fiscal 2005.

A net foreign exchange gain of $1.0 million was recorded for Q2-2005, as compared to a net foreign exchange gain of $0.2 million for Q2-2004, and $1.4 million for the six months ended June 30, 2005 as compared to $0.4 million for the same period in fiscal 2004. The increase in net foreign exchange gain was mainly due to the result of the appreciation of the U.S. dollar in comparison to the Canadian dollar since the end of fiscal 2004 on our U.S. dollar denominated working capital balances carried forward from the end of fiscal 2004. Our increased U.S. dollar denominated investment portfolio balances from the completion of our financing in March 2005 also contributed to the higher foreign exchange gain in the current fiscal period. We are exposed to market risk related to currency exchange rates in the U.S. and Europe because the majority of our clinical development expenditures are incurred in U.S. dollars and Euros. Some of this risk is offset by the reimbursements from Astellas which are in U.S. dollars.

Future Income Tax Recovery
Future income tax recovery was $2.3 million for Q2-2005 as compared to $0.5 million for Q2-2004, and $4.0 million for the six months ended June 30, 2005 as compared to $1.0 million for the same period in fiscal


2004. The increase in the recovery for both periods was mainly due to the recognition of the tax benefits of the current fiscal periods’ losses of the U.S. subsidiary. This was offset by a reduction in amortization of future income tax recovery related to the Oxypurinol gout project which was recognized at the time the related intangible asset was written off.

Liquidity and Capital Resources
Sources and Uses of Cash
Our operational activities during the six months ended June 30, 2005 were financed mainly by our working capital carried forward from the preceding fiscal year, research collaborative fees collected from Astellas, and the net proceeds from equity financing and exercise of stock options by employees. Cash provided by financing activities in the six months ended June 30, 2005 was primarily composed of $64.6 million of the net proceeds of the public offering completed in March 2005, as described in Note 4 of the interim consolidated financial statements, and the proceeds of $1.7 million received from the issuance of our common shares upon exercise of stock options. $0.3 million of the cost associated with the March 2005 public offering was recorded in Q2-2005 as cash used in financing activities. Cash provided by financing activities of $4.6 million and $6.3 million in Q2-2004 and the six months ended June 30, 2004, respectively, was mainly from the issuance of our common shares upon exercise of share purchase warrants and stock options.

Cash used in operating activities for Q2-2005 was $7.8 million, as compared to $9.6 million of cash used in operating activities for Q2-2004. Cash used in operating activities was composed of net loss, add-backs or adjustments not involving cash, net change in non-cash working items, and the amortization of deferred revenue. The decrease of $1.8 million in cash used in operating activities in Q2-2005, as compared to Q2-2004, was due to a decline in net loss by $2.1 million and offset by a reduction of net cash used in settlement of non-cash working capital items by $1.3 million. These were offset by a decline in non-cash add-backs of $1.6 million and an increase in amortization of deferred revenue of $0.1 million. Cash used in operating activities for the six months ended June 30, 2005 was $4.9 million, as compared to $13.2 million for the same period in fiscal 2004. The decrease of $8.3 million in cash used in operating activities for the six months ended June 30, 2005, as compared to the same period in 2004, was due to a decline in amortization of deferred revenue by $0.6 million and an increase in cash provided by settlement of non-cash working capital items by $10.6 million. The significant increase in cash receipt from non-cash working items in this period was mainly due to the collection of the US$6 million milestone receivable from Astellas. These were offset by an increase in net loss by $0.7 million and a decline in non-cash add-backs by $2.2 million.

Cash used in investing activities for Q2-2005 was $21.7 million, as compared to $0.5 million of cash provided by investing activities for Q2-2004. The increase of $22.2 million in cash used in investing activities was due to the increase of net purchases of short-term investments by $22.6 million which was offset by a decrease of $0.4 million in capital assets and patents additions. Cash used in investing activities for the six months ended June 30, 2005 was $30.5 million, as compared to $3.5 million of cash used in investing activities for the same period in fiscal 2004.

The increase of $27.0 million in cash used in investing activities was due to an increase of $28.1 million in net purchases of short-term investments which was offset by a decrease of $1.1 million in capital assets and patents additions.

As at June 30, 2005, we had working capital of $76.0 million, as compared to $26.8 million at December 31, 2004. We had available cash reserves comprised of cash, cash equivalents and short-term investments of $84.8 million at June 30, 2005, as compared to $24.4 million at December 31, 2004.

Outstanding Share Capital
As at July 31, 2005, there were 50,987,405 common shares issued and outstanding, 4,957,452 common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $5.38 per share, and 169,974 common shares issuable upon the exercise of outstanding warrants at a weighted-average exercise price of US$4.16 per share.


Conference Call Notification
Cardiome will hold a teleconference and webcast on Thursday, August 11, 2005 at 4:00 pm EST (1:00 am PST). Please dial 888-280-8771 or 416-695-9720 to access the call. There will be a separate dial-in line for analysts on which we will respond to questions at the end of the presentation. The webcast can be accessed through Cardiome’s website at www.cardiome.com.

About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a product-focused cardiovascular drug development company with three clinical drug programs, two of which focus on atrial arrhythmia (intravenous and oral dosing) and one directed at congestive heart failure.

RSD1235 IV is the intravenous formulation of an investigational drug being evaluated for the acute treatment of recent-onset atrial fibrillation (AF). RSD1235 also has a potential application as a chronic-use oral drug for the maintenance of normal heart rhythm following termination of AF. Top-line results from ACT 1, the first of three Phase 3 trials for RSD1235 IV, were released in December 2004 and February 2005.

Cardiome's lead drug in the congestive heart failure (CHF) area is oxypurinol, a xanthine oxidase inhibitor. CHF is the failure of the heart to pump blood at a rate sufficient to support the body's needs. A Phase 2 clinical trial that evaluates the safety and effectiveness of oxypurinol in the treatment of patients with moderate to severe symptomatic CHF has been completed. Results from this study are expected in Q3/05.

Cardiome is traded on the Toronto Stock Exchange (COM) and the NASDAQ National Market (CRME). Further information about Cardiome can be found at www.cardiome.com.

For Further Information:
Don Graham Peter K. Hofman
Director of Corporate Communication Director of Investor Relations
(604) 676-6963 or Toll Free: 1-800-330-9928 (604) 676-6993 or Toll Free: 1-800-330-9928
Email: dgraham@cardiome.com Email: phofman@cardiome.com

Forward-Looking Statement Disclaimer
Statements contained in this news release relating to future results, events and expectation are forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievement of the company, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such statements. Such factors include, among others, those described in the Company's annual report on Form 40-F. The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this release.



Balance Sheets June 30, 2005 December 31, 2004

Cash and cash equivalents
Short-term investments
Amounts receivable
Prepaid expenses
$ 38,651,493
46,147,193
5,935,069
1,036,971
$ 7,673,892
16,693,319
14,289,307
1,131,591
Total current assets
Capital assets
Intangible assets
91,770,726
2,912,336
24,284,236
39,788,109
2,687,290
25,851,072
Total assets
$ 118,967,298
$ 68,326,471

Current liabilities
Long-term portion of deferred revenue
Long-term portion of deferred leasehold inducement
Future income tax liability
Shareholders’ equity
$ 15,815,662
1,599,919
812,144
941,000
99,798,573
$ 12,968,960
4,015,106
859,984
4,918,000
45,564,421
Total liabilities and shareholders’ equity $ 118,967,298 $ 68,326,471

Statements of Loss and Deficit For the Three Months Ended For the Six Months Ended  
June 30, 2005 June 30, 2004 June 30, 2005 June 30, 2004
Revenue
Licensing fees
Research collaborative fees

$1,215,470
2,591,599

$1,085,121
4,184,158

$2,417,583
5,999,318

$3,052,020
7,206,752
   3,807,069
5,269,279
8,416,901
10,258,772
Expenses
Research and Development
General and Administration
Amortization
11,940,165
2,192,394
1,066,523


12,431,534
2,181,902
1,470,050


23,448,995
4,116,634
2,154,674


20,008,364
3,729,045
2,869,756
   15,199,082
16,083,486
29,720,303
26,607,165
Operating loss
(11,392,013)
(10,814,207)
(21,303,402)
(16,348,393)
Other income
Interest and other income
Foreign exchange gain

512,685
968,201

277,284
210,864

626,882
1,433,544

408,771
401,743
   1,480,886
488,148
2,060,426
810,514
Loss before income taxes
Future income tax recovery
$(9,911,127)
2,253,000
$(10,326,059)
$485,000
$(19,242,976)
3,977,000
$(15,537,879)
970,000
Net Loss for the period
Deficit, beginning of period
$(7,658,127)
(99,666,521)
(9,841,059)
(69,018,449)
$(15,265,976)
(92,058,672)
$(14,567,879)
(64,291,629)
Deficit, end of period
$(107,324,648)
$(78,859,508)
$(107,324,648)
$(78,859,508)
Basic and diluted loss per common share1 $(0.15) $(0.25) $(0.33) $(0.38)

1 Basic and diluted loss per common share is based on the weighted average number of common shares outstanding during the period.


EX-99.4 5 exhibit99-4.htm MATERIAL CHANGE REPORT DATED AUGUST 11, 2005 Filed by Automated Filing Services Inc. (604)609-0244 - Cardiome Pharma Corp. - Exhibit 99.4

FORM 53-901F

SECURITIES ACT

MATERIAL CHANGE REPORT UNDER
SECTION 85(1) OF THE SECURITIES ACT (BRITISH COLUMBIA)
AND EQUIVALENT LEGISLATION OF OTHER JURISDICTIONS

Item 1. REPORTING ISSUER
 
Cardiome Pharma Corp.
6190 Agronomy Road, 6th Floor
Vancouver, BC V6T 1Z3
   
Item 2. DATE OF MATERIAL CHANGE
 
August 11, 2005
   
Item 3. PRESS RELEASE
 
August 11, 2005 – Vancouver, British Columbia
   
Item 4. SUMMARY OF MATERIAL CHANGE
 
Cardiome Pharma Corp. reported financial results for the second quarter ended June 30, 2005.
   
Item 5. FULL DESCRIPTION OF MATERIAL CHANGE
 
See attached press release.
   
Item 6. RELIANCE ON SECTION 85(2) OF THE SECURITIES ACT (BRITISH COLUMBIA) AND EQUIVALENT LEGISLATION OF OTHER JURISDICTIONS
 
Not Applicable.
   
Item 7. OMITTED INFORMATION
 
Not Applicable.
   
Item 8. SENIOR OFFICER
 
Name:                    Christina Yip
Title:                      Vice President, Finance and Administration
Phone No.:            604-677-6905
   
Item 9. STATEMENT OF SENIOR OFFICER
 
The foregoing accurately discloses the material change referred to herein.


Dated at Vancouver, British Columbia, this 11th day of August, 2005.

  CARDIOME PHARMA CORP.
     
  Per:  
   
   

Christina Yip,
Vice President, Finance and Administration

IT IS AN OFFENCE FOR A PERSON TO MAKE A STATEMENT IN A DOCUMENT REQUIRED TO BE FILED OR FURNISHED UNDER THE ACT OR THIS REGULATION THAT, AT THE TIME AND IN THE LIGHT OF THE CIRCUMSTANCES UNDER WHICH IT IS MADE, IS A MISREPRESENTATION.


EX-99.5 6 exhibit99-5.htm INTERIM FINANCIAL STATEMENTS FOR THE QUARTER ENDED JUNE 30, 2005 Filed by Automated Filing Services Inc. (604)609-0244 - Cardiome Pharma Corp. - Exhibit 99.5

FIRST QUARTERLY FINANCIAL REPORT – JUNE 30, 2005

President’s Letter

Dear Shareholders:

During the second quarter of 2005, Cardiome continued to work toward our clinical and corporate goals, with significant progress in our two leading clinical programs.

Finance & Corporate Development

On the heels of our successful US$58.6 million financing in the first quarter, U.S. interest in Cardiome has continued to broaden. In mid-May we were selected for inclusion in the well-followed NASDAQ Biotechnology Index. We are weighted 0.23% of the index, ranking us 96th out of 158 companies included – a top 100 start! We were also pleased to welcome initiation of research coverage by Boston-based Leerink Swann & Company late in the quarter. We are currently covered by 10 research analysts in Canada and 2 in the U.S.

We have continued to be active in attending international investor conferences, including several invitations to New York for the UBS Global Specialty Pharmaceuticals Conference, Needham Biotechnology Conference and BioCentury Future Leaders in the Biotech Industry Conference.

Clinical Development

Cardiome’s intravenous RSD1235 program continues to move forward. In early May, we presented detailed final results from the ACT 1 clinical trial at the annual meeting of the Heart Rhythm Society in New Orleans. The data covered included QTc, adverse events and additional trial design and patient population details. In July we announced completion of enrolment for the ACT 3 trial, and expect top-line results for this trial in the third quarter, an important milestone in advancement of our NDA submission.

Cardiome’s oral RSD1235 program continues to progress. We successfully completed a Phase 1b clinical trial investigating oral RSD1235 as a function of fed and fasted states. On the basis of these results, we have now initiated and completed enrolment in a Phase 1c clinical trial that will investigate the safety and efficacy of RSD1235 in multi-day dosing. This series of Phase 1 trials has been designed to support the initiation of a Phase 2 proof-of-concept clinical trial in the second half of 2005. Oral RSD1235 is designed to be used as a follow-on therapy to RSD1235 IV, with the goal of preventing the recurrence of atrial fibrillation.

We also released full results for the EXOTIC-EF Phase 2 proof-of-principle study for oxypurinol in congestive heart failure. The study confirmed interim results released in the fall of last year, which indicated that oxypurinol appears to have beneficial cardiac effects. With the release of results for our large Phase 2 trial “OPT-CHF”, we hope to provide further evidence of this beneficial effect in congestive heart failure patients.

We look forward to an exciting series of clinical milestones. We expect to release results for OPT-CHF, our 404-patient congestive heart failure trial, in the third quarter of the year. We also anticipate that results from ACT 3, the second Phase 3 trial to be used to support our NDA application for intravenous RSD1235, will be released in the third quarter.

As we continue to drive forward toward an event-filled remainder of the year, I would like to again thank all of our shareholders for their continued support.

“Bob Rieder”

Bob Rieder
President & CEO


MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS

This discussion and analysis covers the unaudited interim consolidated financial statements for the three and six months ended June 30, 2005 prepared in accordance with Canadian generally accepted accounting principles. These principles differ in certain respects from United States generally accepted accounting principles. The differences as they affect interim consolidated financial statements are described in Note 7 to the unaudited interim consolidated financial statements. All amounts are expressed in Canadian dollars unless otherwise indicated.

This discussion and analysis was performed by management using information available as at July 28, 2005. The forward-looking statements in this discussion regarding our expectations regarding our future performance, liquidity and capital resources and other non-historical statements in this discussion include numerous risks and uncertainties, as described in the “Risk Factors” section of our Annual Information Form. Our actual results may differ materially from those contained in any forward-looking statements. Additional information relating to our company, including our 2004 Annual Report, is available by accessing the SEDAR website atwww.sedar.com or the EDGAR website at www.sec.gov/edgar.

Overview

We are a life sciences company focused on developing proprietary drugs to treat or prevent cardiovascular diseases. Our current efforts are focused on the treatment of atrial arrhythmias and congestive heart failure.

Atrial fibrillation (AF), is an arrhythmia, or abnormal rhythm, of the upper chambers of the heart. In December 2004, we announced positive top-line Phase III results for our intravenous formulation of RSD1235, (RSD1235 (iv)), our lead product candidate for the acute conversion of atrial fibrillation, and are currently conducting two additional Phase III trials in conjunction with Astellas Pharma US, Inc. (“Astellas”, formerly Fujisawa Healthcare, Inc., renamed after the merger of Fujisawa Pharmaceutical Co., Ltd. and Yamanouchi Pharmaceutical Co., Ltd.), our collaborative partner. We are also developing an oral formulation of RSD1235 (RSD1235 (oral)), as maintenance therapy for the long-term treatment of atrial fibrillation and intend to initiate a Phase II clinical trial in the second half of 2005.

Congestive heart failure (CHF), is the failure of the heart to pump blood at a rate sufficient to support the body’s needs. In December 2004, we completed enrollment in a Phase II trial of oral Oxypurinol in 404 patients with congestive heart failure.

The following table summarizes current and recently completed clinical studies of each of our research and development projects:

Project    Stage of Development   Current Status
         
RSD1235 (iv)   1st Phase III Clinical Trial (ACT 1)   Trial completed and top-line results
  released in December 2004 and February
  2005. Full trial results presented in May 2005.
  2nd Phase III Clinical Trial (ACT 2)   Trial initiated in March 2004
     3rd Phase III Clinical Trial (ACT 3)   Patient recruitment completed in July 2005
RSD1235 (oral)   Phase I — Formulation Evaluation Study   Interim results released in November
  2004 and controlled release formulation
  selected
  Phase I — Food Effect Study   Trial completed in April 2005
      Phase I — 7 day Repeat Dosing Study   Trial initiated in April 2005
Oxypurinol CHF   Phase II Clinical Trial — (OPT-CHF)   Patient recruitment completed in
  December 2004
  Phase II Proof of Concept Trial — IV (Exotic EF)   Final results announced in April 2005
  Phase II Proof of Concept Trial — Oral   Final results announced in February 2005
  (LaPlata)

The following are significant events which occurred since our last quarterly report:

  • We have been selected to become a member of the NASDAQ Biotechnology Index(R). Our inclusion in the index became effective on May 23, 2005.
     
  • We completed patient enrolment in our second pivotal Phase 3 atrial fibrillation trial, ACT 3, in July 2005. The study is being conducted by our co-development partner, Astellas. The study will evaluate the safety and efficacy of intravenous RSD1235 in 276 patients with atrial arrhythmia. The multinational placebo-controlled study is being conducted at more than 50 centers in North America, South America and Europe.

Critical Accounting Policies and Significant Estimates

Our unaudited interim consolidated financial statements are prepared in accordance with Canadian GAAP. These accounting principles require us to make certain estimates and assumptions. 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 are made. Actual results could differ from these estimates. Areas requiring significant estimates include the assessment of net recoverable value and amortization period of technology licenses and patents, determination of accrued liabilities with respect to clinical trials, recognition of revenue, recognition of future income tax assets and stock-based compensation.

The significant accounting policies that we believe are the most critical in fully understanding and evaluating the reported financial results include the following:

  • intangible assets;

  •  
  • accrued liabilities and clinical trial expenses;

  •  
  • revenue recognition;

  •  
  • research and development costs;

  •  
  • stock-based compensation; and

  •  
  • income taxes

Intangible Assets

Intangible assets are comprised of purchased technology licenses and patent costs. Technology licenses, including those acquired in exchange for the issuance of equity instruments by us, are amortized on a straight-line basis over the estimated useful life of the underlying technologies. We determine the estimated useful lives for intangible assets based on a number of factors: legal, regulatory or contractual limitations; known technological advances; anticipated demand; and the existence or absence of competition. A significant change in any of the above factors may require a revision of the expected useful life of the intangible asset, resulting in accelerated amortization or an impairment charge, which could have a material impact on our results of operations. We evaluate the recoverability of the net book value of our intangible assets on a quarterly basis based on the expected utilization of the underlying technologies. If the carrying value of the underlying technology exceeds the estimated net recoverable value, calculated based on undiscounted estimated future cash flows, the shortfall amount is charged to operations. The amounts shown for technology licenses and patent costs do not necessarily reflect present or future values and the ultimate amount recoverable will be dependent upon the successful development and commercialization of products based on these rights. Patent costs associated with the preparation, filing, and obtaining of patents are capitalized and amortized on a straight-line basis over the estimated useful lives of the patents.

Accrued Liabilities and Clinical Trial Expenses

We have entered into service agreements with various contract research organizations, investigators and other vendors that provide resources, services and expertise that complement our efforts in developing our drug candidates. These agreements may be in force over a number of fiscal years or accounting periods. Since payments under these agreements may not coincide with the period in which the services are rendered, judgment is required in estimating the amount of clinical trial expense to be recorded in each accounting period. Judgment and estimates are also involved in determining the amount of expenditures that are contractually committed under the various agreements. We consider the following factors in estimating the amount of clinical trial expense for an accounting period: the level of patient enrollment; the level of services provided and goods delivered; and the proportion of the overall contracted time that elapsed during the accounting period. In making these assessments, we monitor patient enrollment levels and related activities at a given point in time


through internal reviews, correspondence and discussions with contractors and review of contractual terms. We may sometimes rely on the information provided by our contractors. A significant change in the above factors and the accuracy of information provided by our contractors may alter our estimate of our clinical trial expenditure for the accounting period and prepaid expenses or accrued liabilities as of the end of the accounting period. This could have a material impact on our results of operations and liabilities.

Revenue Recognition

Revenue to date has primarily been derived from research collaborative fees and licensing fees, which are comprised of initial fees and milestone payments from collaborative licensing arrangements and related reimbursement of expenses. Non-refundable research collaborative fees are recorded as revenue as the related research expenses are incurred pursuant to the terms of the agreement, provided collectibility is reasonably assured. Non-refundable milestone payments are fully recognized upon the achievement of the milestone event when we have no further involvement or obligation to perform under the arrangement. Initial fees and milestone payments which require our ongoing involvement are deferred and amortized into income over the estimated period of our ongoing involvement. A significant change in estimating the period of our on-going involvement could have a material impact on results of operations.

Research and Development Costs

Research and development costs consist of direct and indirect expenditures related to our research and development programs. Research and development costs are expensed as incurred unless they meet generally accepted accounting criteria for deferral and amortization. We assess whether these costs have met the relevant criteria for deferral and amortization at each reporting date. No development costs have been deferred.

Stock-based Compensation and other Stock-based Payments

Effective December 1, 2002, we have elected to prospectively adopt the recommendations of the Canadian Institute of Chartered Accountants, or CICA, in new section 3870 of the CICA Handbook, with respect to stock-based compensation and other stock-based payments. This standard requires that all share-based awards be measured and recognized as an expense using a fair value based method.

The fair value of stock options is estimated at the date of grant using the Black-Scholes option pricing model with the subjective assumptions of the expected life of the option, the expected volatility at the time the options are granted, and risk-free interest rate. Changes in these assumptions can materially affect the measure of the estimated fair value of our employee stock options, hence our results of operations. We amortize the fair value of stock options over the vesting terms of the options which are generally four to five years from grant.

For the three months ended June 30, 2005, we recorded approximately $1.5 million and $36,000 of stock-based compensation for stock options granted after December 1, 2002, to employees and non-employees, respectively. For the six months ended June 30, 2005, we recorded approximately $3.1 million and $85,000 of stock-based compensation for stock options granted after December 1, 2002, to employees and non-employees, respectively.

Future Income Taxes

Income taxes are accounted for using the liability method of tax allocation. Future income taxes are recognized for the future income tax consequences attributable to differences between the carrying values of assets and liabilities and their respective income tax bases. Future income tax assets and liabilities are measured using substantively enacted income tax rates expected to apply to taxable income in the years in which temporary differences are expected to be recovered or settled. The effect on future income tax assets and liabilities of a change in rates is included in earnings in the period that includes the enactment date. Future income tax assets are recorded in the financial statements if realization is considered more likely than not.

Results of Operations

For the three months ended June 30, 2005 (“Q2-2005”), we recorded a net loss of $7.7 million ($0.15 per common share), compared to a net loss of $9.8 million ($0.25 per common share) for the three months ended June 30, 2004 in the preceding fiscal year (“Q2-2004”). On a year-to-date basis, we recorded a net loss of $15.3 million ($0.33 per common share) for the six months ended June 30, 2005, compared to a net loss of $14.6 million ($0.38 per common share) for the six months ended June 30, 2004.

The decline in net loss by $2.1 million in Q2-2005, as compared to the net loss in Q2-2004, was due to a decline in total operational expenditures by $0.9 million, an increase in other income by $1.0 million, and an increase future income tax recovery by$1.7 million; these were offset by a decline in total revenue by $1.5 million. The increase of net loss by $0.7 million for the six months ended June 30, 2005, as compared to the same period in fiscal 2004, was due a decline in total revenue by $1.9 million and an increase in total operational expenditures by $3.1 million; these were offset by an increase in other income by $1.3 million, and an increase in future income tax recovery by $3.0 million. These results of operations were in line with our expectations.

We expect losses to continue for at least the next two fiscal years as we advance RSD1235 (oral) and oxypurinol CHF into later stage development. These chronic treatment product candidates will require substantial funding in Phase II and Phase III clinical development. As such, we expect our operating expenses for these product candidates to be higher than the


potential licensing and research collaborative fees or royalty revenue from RSD1235 (iv), should we successfully meet our collaborative milestones or obtain commercialization approval for RSD1235 (iv) within this period.

Revenues

Total revenue for Q2-2005 declined to $3.8 million from $5.3 million for Q2-2004. On a year to date basis, total revenue for the six months ended June 30, 2005 was $8.4 million as compared to $10.3 million for the same period in fiscal 2004. Total revenue comprised of licensing fees and research collaborative fees we collected from our collaborative partners as described below.

Licensing fees represent the amortization of deferred revenue related to upfront payments and premium on equity investment from our collaborative partners. We recorded $1.2 million of licensing fees for Q2-2005 as compared to $1.1 million for Q2-2004, and $2.4 million for the six months ended June 30, 2005, as compared to $3.1 million for the same period in fiscal 2004. The current quarter increase was largely due to the amortization of deferred revenue of $0.1 million ($Nil for Q2-2004) associated with the additional deferred revenue relating to the premium on equity investment from Astellas. The decrease of $0.7 million of licensing fees on a year-to-date basis, as compared to the same six month period in fiscal 2004, was primarily due to the recognition of the remaining $0.9 million of unamortized deferred revenue related to the upfront payment from our former collaborative partner, UCB Farchim S.A, or UCB. This was offset by the amortization of deferred revenue of $0.2 million ($Nil for the six months ended June 30, 2004) associated with the additional deferred revenue relating to the premium on equity investment from Astellas.

Research and collaborative fees are composed of project management fees and contract research fees we charged collaborative partners for our work and the associated out of pocket expenses we recovered from them. Research collaborative fees were $2.6 million for Q2-2005, as compared to $4.2 million for Q2-2004, and $6.0 million for the six months ended June 30, 2005, as compared to $7.2 million for the same period in fiscal 2004. The decrease for both periods was primarily due to the reduced research and development collaborative fees from Astellas. Out of pocket expenses associated with RSD1235 (iv) operational activities that we directly incurred have reduced by $1.9 million in Q2-2005 as compared to Q2-2004, and $1.6 million for the six month period ended June 30, 2005, as compared to the same period in fiscal 2004, due to the completion of ACT 1 in early 2005. This was offset by an increase of $0.3 million and $0.4 million in project management fees and contract research fees for Q2-2005 and for the six months ended June 30, 2005, respectively, as compared to the same periods in fiscal 2004. Included in these fees in fiscal 2004 was a $0.2 million contract research fees from our former collaborative partner, UCB Farchim S.A. which was terminated in March 2004.

For the remainder of the current fiscal year, we expect to continue recognizing as revenue the amortization of deferred revenue related to the upfront payment and the premium on equity investment from Astellas. We will also continue to receive project management fees and development cost reimbursements from Astellas.

Research and Development Expenditures

Research and development expenditures were $11.9 million for Q2-2005, as compared to $12.4 million for Q2-2004. We incurred total research and development expenditures of $23.4 million for the six months ended June 30, 2005, as compared to $20.0 million for same period in fiscal 2004.

Research and development expenditures for Q2-2005 were comparable to the amount recorded for Q2-2004. The increase of $3.4 million in research and development expenditures for the six-months ended June 30, 2005, as compared to those incurred for the six months ended June 30, 2004, was primarily due to the expanded clinical development activities during the six months ended June 30, 2005, with continuation or completion of three Phase III studies of RSD1235 (iv) [ACT 1, ACT 2 and ACT 3], one Phase II regulatory study [OPT-CHF], two Phase II proof-of-concept studies [Exotic-EF and LaPlata] of Oxypurinol, and two Phase I studies of RSD1235 (oral).



   Amount in million of Canadian $
Project For the Three Months Ended For the Six Months Ended
   June 30, 2005 June 30, 2004 June 30, 2005 June 30, 2004
RSD1235 (iv) $4.3 $7.1 $11.2 $11.8
RSD 1235 (oral) $3.3 $1.6 $4.9 $2.2
Oxypurinol CHF $4.2 $1.9 $7.1 $3.5
Non-core project $0.1 $1.8 $0.2 $2.5
Total research and development expenses $11.9 $12.4 $23.4 $20.0

We expect our research and development expenditures for the current fiscal year to be higher than those incurred in fiscal 2004. The majority of the increase will be associated with our RSD1235 (iv) and RSD1235 (oral) projects.

The following provides a description of major clinical trial(s) and research and development expenditure for each of our projects:

RSD1235 (iv)

During Q2-2005, we continued our work on two additional Phase III clinical trials, ACT 2 and ACT 3.

The ACT 1 Study

The study looked at three sub-groups of patients, including 237 patients with recent-onset atrial fibrillation (more than three hours but less than seven days), 119 patients with longer-term atrial fibrillation (more than seven days but less than 45 days) and 60 patients with atrial flutter. The primary endpoint in ACT 1 was conversion of recent-onset atrial fibrillation to normal heart rhythm for a period of at least one minute post-dosing within 90 minutes of the start of dosing. The study was carried out in 45 centers in the U.S., Canada and Scandinavia. We completed enrollment in ACT 1 in October 2004 and announced that the study achieved its primary end points in December 2004. Additional clinical results of this study were released in February 2005 and a full trial report was presented in May 2005 at the Late Breaking Clinical Results section of the Heart Rhythm Society Meeting in New Orleans.

The ACT 2 Study

The ACT 2 study, initiated in March 2004, will enroll approximately 210 patients and will evaluate the efficacy and safety of RSD1235 (iv) in the treatment of patients who have developed transient atrial fibrillation following cardiac surgery. The primary endpoint in this study is acute conversion of atrial fibrillation to normal heart rhythm.

The ACT 3 Study

Our collaborative partner, Astellas initiated the ACT 3 study in July 2004 and completed patient recruitment for this study in July 2005. ACT 3 enrolled 276 patients. The primary efficacy endpoint of the ACT 3 trial is acute conversion of atrial fibrillation to normal heart rhythm in recent-onset atrial fibrillation patients. The study also includes analysis of patients with longer-term atrial fibrillation and patients with atrial flutter. Safety observations focus on sensory and cardiovascular effects of the drug, with particular emphasis on lack of side-effect arrhythmias. We expect to announce top-line results in the 3rd quarter of 2005.

Total research and development expenditures for this project were $4.3 million for Q2-2005, as compared to $7.1 million for Q2-2004. On the year-to-date basis, our expenditures for this project were $11.2 million for the six months ended June 30, 2005, as compared to $11.8 million for the six months ended June 30, 2004. Also included in the expenditures were the costs associated with the manufacturing of stability batches of RSD1235 and clinical drug supplies. These stability batches will generate manufacturing data required for our potential NDA in later 2005 or early 2006.

We expect our research and development expenditures for this project to be higher for the current fiscal year than those incurred in fiscal 2004. The anticipated cost will relate to the final data analysis for ACT 1, ongoing ACT 2 study, completion of ACT 3 and preparation of the NDA.

The RSD1235 (oral)

In September 2004, we initiated dosing of RSD1235 (oral) in 12 healthy volunteers in a Phase I formulation evaluation study in Europe. This study was an open-label, cross-over evaluation of two sustained release formulations of RSD1235


(oral) in comparison to an immediate release formulation of RSD1235 (oral). Based on the successful completion of the study in November 2004, we have chosen a controlled release formulation for further clinical development.

In November 2004, we initiated a food effect study. The objective of the study was to further evaluate the effect of food on the absorption of our controlled release formulation of RSD1235 in patients under both fed and fasted conditions. Based on the successful completion of the study in April 2005, the results confirmed that RSD1235 absorption is not significantly affected by food, suggesting that dosing need not be restricted according to meal time.

Total research and development expenditures for this project were $3.3 million for Q2-2005, as compared to $1.6 million for Q2-2004. On the year-to-date basis, our expenditures for this project were $4.9 million for the six months ended June 30, 2005, as compared to $2.2 million for the same period in fiscal 2004. The increase was the result of the increased operational activities associated with the series of Phase I clinical trials ongoing, manufacture of drug supplies, and pre-clinical toxicology testing work.

We expect our research and development expenditures for this project to be higher for the current fiscal year than those incurred in fiscal 2004 as we advance this project into Phase II clinical testing this year.

Oxypurinol for Congestive Heart Failure Project

During Q2-2005, we continued our work on the OPT-CHF study.

The OPT-CHF Study

OPT-CHF which was initiated in March 2003 finished its patient recruitment in December 2004. The placebo-controlled study investigates the impact of 24 weeks of daily oral dosing of Oxypurinol (600 mg/day) on the clinical outcomes of an expected 404 moderate to severe symptomatic heart failure patients.

The study enrolled New York Heart Association class III and IV patients with ejection fractions less than or equal to 40%. All randomized patients had experienced at least one hospitalization or emergency room visit for heart failure in the previous 18 months, or had a new heart failure medication added to their drug regimen due to lack of medical stability.

The primary end point of the study is a composite that assigns all patients to one of three categories: improved, unchanged or worsened. Improvement consists of improvement in New York Heart Association class or improvement in patient global heart failure assessment. Worsening includes death, re-hospitalization or emergency clinic visit, requirement for acute change in medication, and other factors. We have completed patient recruitment and expect to report the results in the third quarter of 2005. If successful, we may initiate a Phase III clinical trial in 2006.

The EXOTIC-EF Study

In April 2005, we announced positive final results for an investigator-sponsored study, EXOTIC-EF. This open-label study, which was conducted in Europe, evaluated intravenous dosing of Oxypurinol in 20 catheterized congestive heart failure patients. The endpoints of this study were left-ventricle ejection fraction and cardiac oxygen consumption. The reported data covered all 18 patients who met the prospectively-defined entry criteria.

The LaPlata Study

This investigator-sponsored randomized, double-blinded, placebo controlled trial involved 28 days of oral dosing of Oxypurinol in Congestive Heart Failure patients with left-ventricle ejection fraction equal to less than 40% and class II-III congestive heart failure as rated by the New York Heart Association classification system. The trial enrolled a total of 60 patients, of whom 47 met the entry criteria. The remaining 13 patients enrolled had left ventricle ejection fractions exceeding 40%, as measured by blinded reading of echocardiograms upon completion of the study. Final results were announced in February 2005. This study showed a statistically-significant improvement in an important measurement of cardiac function, the left ventricle ejection fraction. Improvement in the exercise tolerance (6 minute walk test) was seen in both treatment groups; however, no statistically significant difference between the two groups was observed.

As expected, with multiple clinical trials ongoing, our expenditures for this project increased substantially. Research and development expenditures for this project were $4.2 million for Q2-2005 as compared to $1.9 million for Q2-2004, and $7.1 million for the six months ended June 30, 2005 as compared to $3.5 million for the same period in fiscal 2004.

We expect our research and development expenditures for this project for the current fiscal year to be comparable to those incurred in fiscal 2004 as we complete all of the above studies, including the 404-patients OPT-CHF study, this year.


Other Non-core Projects

Following our decision to stop pursuing the allopurinol intolerant gout indication for Oxypurinol in 2004, research and development expenditures for the Oxypurinol gout project decreased substantially to $0.1 million for Q2-2005 as compared to $1.4 million for Q2-2004, and $0.2 million for the six months ended June 30, 2005 as compared to $2.0 million for the same period in fiscal 2004. The expenditures incurred for Q2-2005 and the six months ended June 30, 2005 were associated with our Compassionate Use Program for allopurinol intolerant gout patients. Expenditures associated with other experimental research declined to $Nil for the six months ended June 30, 2005 from $0.5 million for the six months ended June 30, 2004.

General and Administration Expenditures

General and administration expenditures for Q2-2005 were $2.2 million, which was comparable to the amount recorded for Q2-2004. On a year to date basis, we incurred a total general and administration expenditure of $4.1 million for the six months ended June 30, 2005, as compared to $3.7 million for the same period in fiscal 2004. The increase of $0.4 million for the six months ended June 30, 2005, as compared to those incurred for the six months ended June 30, 2004, was largely attributable to the increase of $648,000 in business development expenditures associated with out-licensing and in-licensing activities. This was offset by the decrease of $118,000 and $109,000 in consulting and professional fees and wages and benefits, respectively.

For the current fiscal year, we expect our general and administration expenditures to be comparable to those incurred in fiscal 2004.

Amortization

Amortization was $1.1 million for Q2-2005 as compared to $1.5 million for Q2-2004, and $2.2 million for the six months ended June 30, 2005 as compared to $2.9 million the same period in fiscal 2004. The decrease in amortization for both periods was attributable to the reduced amortization related to our intangible and other assets following the write-down of intangible assets associated with the Oxypurinol gout project in September 2004.

Other Income (Expenses)

Interest and other income was $0.5 million for Q2-2005 as compared to $0.3 million for Q2-2004, and $0.6 million for the six months ended June 30, 2005 as compared to $0.4 million for the same period in fiscal 2004. The increase in interest and other income for both periods was primarily the result of higher balances of cash and cash equivalents and short-term investments in fiscal 2005.

A net foreign exchange gain of $1.0 million was recorded for Q2-2005, as compared to a net foreign exchange gain of $0.2 million for Q2-2004, and $1.4 million for the six months ended June 30, 2005 as compared to $0.4 million for the same period in fiscal 2004. The increase in net foreign exchange gain was mainly due to the result of the appreciation of the U.S. dollar in comparison to the Canadian dollar since the end of fiscal 2004 on our U.S. dollar denominated working capital balances carried forward from the end of fiscal 2004. Our increased U.S. dollar denominated investment portfolio balances from the completion of our financing in March 2005 also contributed to the higher foreign exchange gain in the current fiscal period. We are exposed to market risk related to currency exchange rates in the U.S. and Europe because the majority of our clinical development expenditures are incurred in U.S. dollars and Euros. Some of this risk is offset by the reimbursements from Astellas which are in U.S. dollars.

Future Income Tax Recovery

Future income tax recovery was $2.3 million for Q2-2005 as compared to $0.5 million for Q2-2004, and $4.0 million for the six months ended June 30, 2005 as compared to $1.0 million for the same period in fiscal 2004. The increase in the recovery for both periods was mainly due to the recognition of the tax benefits of the current fiscal periods’ losses of the U.S. subsidiary. This was offset by a reduction in amortization of future income tax recovery related to the Oxypurinol gout project which was recognized at the time the related intangible asset was written off.


Quarterly Financial Data

The selected financial information provided below is derived from our unaudited quarterly consolidated financial statements for each of the last eight quarters, all of which cover periods of three months, except for the quarter ended December 31, 2003, which covers a period of 4 months due to the change of fiscal year end from November 30 to December 31, effective December 31, 2003.

  

June 30,
2005

March
31, 2005
December
31, 2004
September
30, 2004
June 30,
2004
March
31, 2004
December
31, 2003
August
31, 2003
  $ $ $ $ $ $ $ $
    
Total
Revenues
3,807 4,610 11,640 4,505 5,269 4,989 4,925 359
Net income
(loss) for the
period
(7,658) (7,608) 1,787 (14,986) (9,841) (4,727) (5,853) (5,058)
Basic net
income (loss)
per common
share
(0.15) (0.18) 0.05 (0.38) (0.25) (0.13) (0.16) (0.16)
Diluted net
income (loss)
per common
share
(0.15) (0.18) 0.04 (0.38) (0.25) (0.13) (0.16) (0.16)

Total revenues relate to our licensing and research collaborative revenues. The significant increase in revenue since the quarter ended August 31, 2003 is primarily related to our license and research collaborative agreement with Astellas. The primary factor affecting the losses in the various quarters is the number and stage of our clinical development programs as well as the adoption of our accounting policy with respect to recognizing as an expense the fair value of stock options. In addition, the substantial increase in loss for the quarter ended September 30, 2004 is due to the write-down of technology and licenses with respect to the discontinuation of the Oxypurinol gout project.

For the quarter ended December 31, 2004, the significant increase in revenue, when compared with the four months ended December 31, 2003, was due to the recognition of the milestone payment for the successful completion of the 1st Phase III clinical trial of $7.2 million related to RSD1235 (iv).

Liquidity and Capital Resources

Sources and Uses of Cash

Our operational activities during the six months ended June 30, 2005 were financed mainly by our working capital carried forward from the preceding fiscal year, research collaborative fees collected from Astellas, and the net proceeds from equity financing and exercise of stock options by employees. Cash provided by financing activities in the six months ended June 30, 2005 was primarily composed of $64.6 million of the net proceeds of the public offering completed in March 2005, as described in Note 4 of the interim consolidated financial statements, and the proceeds of $1.7 million received from the issuance of our common shares upon exercise of stock options. $0.3 million of the cost associated with the March 2005 public offering was recorded in Q2-2005 as cash used in financing activities. Cash provided by financing activities of $4.6 million and $6.3 million in Q2-2004 and the six months ended June 30, 2004, respectively, was mainly from the issuance of our common shares upon exercise of share purchase warrants and stock options.

Cash used in operating activities for Q2-2005 was $7.8 million, as compared to $9.6 million of cash used in operating activities for Q2-2004. Cash used in operating activities was composed of net loss, add-backs or adjustments not involving cash, net change in non-cash working items, and the amortization of deferred revenue. The decrease of $1.8 million in cash used in operating activities in Q2-2005, as compared to Q2-2004, was due to a decline in net loss by $2.1 million and offset by a reduction of net cash used in settlement of non-cash working capital items by $1.3 million. These were offset by a decline in non-cash add-backs of $1.6 million and an increase in amortization of deferred revenue of $0.1 million. Cash used in operating activities for the six months ended June 30, 2005 was $4.9 million, as compared to $13.2 million for the same period in fiscal 2004. The decrease of $8.3 million in cash used in operating activities for the six months ended June 30, 2005, as compared to the same period in 2004, was due to a decline in amortization of deferred revenue by $0.6 million and an increase in cash provided by settlement of non-cash working capital items by $10.6 million. The significant increase in cash receipt from non-cash working items in this period was mainly due to the collection of the US$6 million milestone receivable from Astellas. These were offset by an increase in net loss by $0.7 million and a decline in non-cash add-backs by $2.2 million.


Cash used in investing activities for Q2-2005 was $21.7 million, as compared to $0.5 million of cash provided by investing activities for Q2-2004. The increase of $22.2 in cash used in investing activities was due to the increase of net purchases of short-term investments by $22.6 million which was offset by a decrease of $0.4 million in capital assets and patents additions. Cash used in investing activities for the six months ended June 30, 2005 was $30.5 million, as compared to $3.5 million of cash used in investing activities for the same period in fiscal 2004. The increase of $27.0 million in cash used in investing activities was due to an increase of $28.1 million in net purchases of short-term investments which was offset by a decrease of $1.1 million in capital assets and patents additions.

As at June 30, 2005, we had working capital of $76.0 million, as compared to $26.8 million at December 31, 2004. We had available cash reserves comprised of cash, cash equivalents and short-term investments of $84.8 million at June 30, 2005, as compared to $24.4 million at December 31, 2004.

As at June 30, 2005 and in the normal course of business we are obligated to make future payments. These obligations represent contracts and other commitments that are known and committed.

Payment Due by Period
           
Total 2005 2006—2007 2008—2009 Thereafter
           
(in thousands of dollars)
Other long-term obligation 218 8 37 45 128
Operating lease obligations 2,897 155 559 683 1,500
Commitments for clinical
     research agreements(1) 6,315 6,315 0 0 0
Commitments under license
     agreement(2) 564 0 196 245 123
        per annum
Total $ 9,994 $ 6,478 $ 792 $ 973 $ 1,751

(1)
The total commitment of $6.3 million reflects $2.4 million of commitments that are non-cancelable and $3.9 million of commitments that are cancelable should we decide to discontinue the related clinical research work.
   
(2)
As of June 30, 2005, pursuant to four license and service agreements, we have various commitments as described in Note 12(d) of the annual consolidated financial statements for the year ended December 31, 2004. The majority of these commitments are contingent upon achievement of certain milestones which may or may not actually occur. The amounts disclosed in this table represent minimum annual royalties described in Note 12(d)(iii), converted from U.S. dollars to Canadian dollars at the closing exchange rate on June 30, 2005 of CAD$0.8161 = US$1.00.

Outstanding Share Capital

As at July 31, 2005, there were 50,987,405 common shares issued and outstanding, 4,957,452 common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $5.38 per share, and 169,974 common shares issuable upon the exercise of outstanding warrants at a weighted-average exercise price of US$4.16 per share.

Related Party Transactions

Included in accounts payable and accrued liabilities at June 30, 2005 is $76,033 (December 31, 2004 - $54,688) owing to a legal firm where the Company’s corporate secretary is a partner. The amounts charged are recorded at the exchange amounts at normal trade terms. For the three and six months ended June 30, 2005, the Company has incurred $82,065 and $690,521 of legal fees for services provided by the legal firm respectively (three months ended June 30, 2004 - $nil; six months ended June 30, 2004 - $Nil), of which $15,135 and $568,495 of the total amount was incurred for the three and six months ended June 30, 2005 respectively in connection with the public offering completed in March 2005.

Off-Balance Sheet Arrangements

We have no off-balance sheet arrangements.

Financial Instruments and Risks

We are exposed to market risks related to changes in interest rates and foreign currency exchange rates. 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. 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 changes that could have a material effect on future operating results or cash flows.

We believe that our current cash position, together with the anticipated cash inflows from our collaborative partner and interest income should be sufficient to finance our operational and capital needs for at least the next two years. However, our future cash requirements may vary materially from those now expected due to a number of factors, including the costs associated with the completion of the clinical trials, collaborative and license arrangements with third parties, and opportunities to in-license complementary technologies. We will continue to review our financial needs and seek additional financing as required from sources that may include equity financing, and collaborative and licensing arrangements. However, there can be no assurance that such additional funding will be available or if available, whether acceptable terms will be offered.



CARDIOME PHARMA CORP.
Continued under the laws of Canada
 
CONSOLIDATED BALANCE SHEETS
(Unaudited - expressed in Canadian Dollars)

As at
June 30, December 31,
2005 2004
ASSETS
     
Current
         Cash and cash equivalents $ 38,651,493 $  7,673,892
         Short-term investments 46,147,193 16,693,319
         Amounts receivable (note 8) 5,935,069 14,289,307
         Prepaid expenses 1,036,971 1,131,591
Total current assets 91,770,726 39,788,109
Capital assets 2,912,336 2,687,290
Intangible assets 24,284,236 25,851,072
$  118,967,298 $  68,326,471
     
LIABILITIES AND SHAREHOLDERS’ EQUITY
     
Current
         Accounts payable and accrued liabilities (notes 5 and 7) $  8,689,324 $  5,833,974
         Deferred revenue 4,866,421 4,868,817
         Future income tax liability 2,164,000 2,164,000
         Current portion of capital lease obligations - 7,061
         Current portion of deferred leasehold inducement (note 3) 95,917 95,108
Total current liabilities 15,815,662 12,968,960
Deferred revenue 1,599,919 4,015,106
Deferred leasehold inducement (note 3) 812,144 859,984
Future income tax liability 941,000 4,918,000
Total liabilities 19,168,725 22,762,050
Contingencies (note 6)
     
Shareholders’ Equity
Share capital (note 4)
       Authorized
           Unlimited number of common and preferred shares
       Issued and outstanding – common shares
           50,865,205 at June 30, 2005
           40,592,834 at December 31, 2004 198,156,438 131,427,488
Contributed surplus 8,966,783 6,195,605
Deficit (107,324,648 ) (92,058,672 )
Total shareholders’ equity 99,798,573 45,564,421
$  118,967,298 $  68,326,471

See accompanying notes
 
On behalf of the Board:
     
Robert Rieder, Director   Fred Mermelstein, Director



CARDIOME PHARMA CORP.
Continued under the laws of Canada
 
CONSOLIDATED STATEMENTS OF LOSS AND DEFICIT  
(Unaudited - expressed in Canadian Dollars)

For the Three Months ended For the Six Months ended  
         
June 30, June 30, June 30, June 30,
2005 2004 2005 2004
Revenue
     Licensing fees $ 1,215,470 $ 1,085,121 $ 2,417,583 $ 3,052,020
     Research collaborative fees 2,591,599 4,184,158 5,999,318 7,206,752
3,807,069 5,269,279 8,416,901 10,258,772
         
Expenses
     Research and development (note 4) 11,940,165 12,431,534 23,448,995 20,008,364
     General and administration (note 4) 2,192,394 2,181,902 4,116,634 3,729,045
     Amortization 1,066,523 1,470,050 2,154,674 2,869,756
15,199,082 16,083,486 29,720,303 26,607,165
Operating loss (11,392,013 ) (10,814,207 ) (21,303,402 ) (16,348,393 )
Other income
     Interest and other income 512,685 277,284 626,882 408,771
     Foreign exchange gain 968,201 210,864 1,433,544 401,743
1,480,886 488,148 2,060,426 810,514
         
Loss before income taxes (9,911,127 ) (10,326,059 ) (19,242,976 ) (15,537,879 )
Future income tax recovery 2,253,000 485,000 3,977,000 970,000
Net loss for the period (7,658,127 ) (9,841,059 ) (15,265,976 ) (14,567,879 )
Deficit, beginning of period (99,666,521 ) (69,018,449 ) (92,058,672 ) (64,291,629 )
Deficit, end of period $  (107,324,648 ) $  (78,859,508 ) $  (107,324,648 ) $ (78,859,508 )
         
Basic and diluted loss per common $  (0.15 ) $  (0.25 ) $  (0.33 ) $ (0.38 )
     share
         
Weighted average number of
     common shares outstanding 50,848,832 39,402,360 46,301,517 38,484,128

See accompanying notes



CARDIOME PHARMA CORP.
Continued under the laws of Canada
 
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited - expressed in Canadian Dollars)

For the Three Months ended For the Six Months ended
         
June 30, June 30, June 30, June 30,
2005 2004 2005 2004
         
Operating Activities
     Net loss for the period $  (7,658,127 ) $  (9,841,059 ) $  (15,265,976 ) $  (14,567,879 )
     Add items not affecting cash:
          Amortization 1,066,523 1,470,050 2,154,674 2,869,756
          Stock-based compensation 1,533,324 1,029,004 3,168,980 1,651,830
          Deferred leasehold inducement amortization (23,672 ) (9,853 ) (47,031 ) (11,694 )
          Write-off of capital assets 7,057 - 7,057 -
          Future income tax recovery (2,253,000 ) (485,000 ) (3,977,000 ) (970,000 )
(7,327,895 ) (7,836,858 ) (13,959,296 ) (11,027,987 )
     Changes in non-cash working capital items
          relating to operations
               Amounts receivable 943,462 (1,313,922 ) 8,354,238 (542,131 )
               Prepaid expenses 179,376 13,043 94,620 (307,803 )
               Accounts payable and accrued liabilities (402,417 ) 636,391 3,037,291 1,722,116
          Deferred revenue (1,215,471 ) (1,085,121 ) (2,417,583 ) (3,052,020 )
 Cash used in operating activities (7,822,945 ) (9,586,467 ) (4,890,730 ) (13,207,825 )
         
 Financing Activities
     Issuance of common shares, net of share
           issuance costs (334,035 ) 4,597,321 66,331,148 6,332,221
     Repayment of obligations under capital leases - (6,705 ) (7,061 ) (13,304 )
 Cash provided by (used in) financing activities (334,035 ) 4,590,616 66,324,087 6,318,917
         
Investing Activities
     Purchase of capital assets (303,751 ) (821,512 ) (516,589 ) (2,331,328 )
     Leasehold inducements - - - 396,300
     Patent costs capitalized (204,503 ) (42,575 ) (485,293 ) (151,392 )
     Purchase of short-term investments (39,011,980 ) (14,679,373 ) (57,366,066 ) (26,526,638 )
     Sale of short-term investments 17,843,289 16,071,168 27,912,192 25,147,108
Cash provided by (used in) investing activities (21,676,945 ) 527,708 (30,455,756 ) (3,465,950 )
         
Increase (decrease) in cash and cash
     equivalents during the period (29,833,925 ) (4,468,143 ) 30,977,601 (10,354,858 )
Cash and cash equivalents,
     beginning of period 68,485,418 8,092,165 7,673,892 13,978,880
Cash and cash equivalents, end of period $ 38,651,493 $ 3,624,022 $ 38,651,493 $ 3,624,022

See accompanying notes



CARDIOME PHARMA CORP.
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited - expressed in Canadian Dollars)

1. BASIS OF PRESENTATION
   
The accompanying unaudited interim consolidated financial statements have been prepared by management in accordance with Canadian generally accepted accounting principles (“Canadian GAAP”) on a basis consistent with the Company’s annual audited consolidated financial statements for the year ended December 31, 2004, except that they do not contain all note disclosures necessary for annual financial statements. These unaudited interim consolidated financial statements conform in all material respects with United States generally accepted accounting principles (“U.S. GAAP”), except as disclosed in note 7.
   
These unaudited interim consolidated financial statements reflect, in the opinion of management, all adjustments (which include reclassifications and normal recurring adjustments) necessary to present fairly the consolidated financial position, consolidated results of operations and consolidated cash flows as at June 30, 2005, and for all periods presented.
   
These unaudited interim consolidated financial statements and notes should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2004 included in the Company’s Annual Report filed with the appropriate securities commission. The results of operations for the three- month and six-month periods ended June 30, 2005 are not necessarily indicative of the results for the full year. All amounts herein are expressed in Canadian dollars unless otherwise noted.
   
The Company has financed its cash requirements primarily from share issuances, payments from research collaborators and licensing fees. 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.
   
2.
SIGNIFICANT ACCOUNTING POLICIES
   
All accounting policies are the same as described in Note 2 to the Company’s audited consolidated financial statements for the year ended December 31, 2004 included in the Company’s 2004 Annual Report filed with the appropriate securities commissions.
   
Certain of the significant accounting policies are as follows:
   
Revenue recognition
   
Research collaborative fees, which are non-refundable, are recorded as revenue as the related research expenses are incurred pursuant to the terms of the agreement and provided collectibility is reasonably assured.
   
Licensing fees comprise initial fees and milestone payments derived from collaborative licensing arrangements. Non-refundable milestone payments are recognized upon the achievement of the specified milestones when the milestone is substantive in nature, the achievement of the milestone was not reasonably assured at the inception of the agreement, and the Company has no further significant involvement or obligation to perform under the arrangement. Otherwise, non-refundable milestone payments and initial fees are deferred and amortized into revenue on a straight-line basis over the estimated period of the ongoing involvement of the Company.



CARDIOME PHARMA CORP.
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited - expressed in Canadian Dollars)

2.
SIGNIFICANT ACCOUNTING POLICIES (Continued)
   
Stock-based compensation and other stock-based payment
   
The Company grants stock options to executive officers and directors, employees, consultants and clinical advisory board members pursuant to its stock option plan. The Company uses the fair value method of accounting for all stock-based awards granted, modified or settled during the period.
   
The fair value of stock options is estimated at the date of grant using the Black-Scholes Option Pricing Model and is amortized over the vesting terms (see Note 4).
   
3.
DEFERRED LEASEHOLD INDUCEMENT
   
Pursuant to a lease agreement, the Company received a cash tenant improvement allowance amounting to $1,030,380 from the landlord for leasehold improvements during the year ended December 31, 2004. $792,600 of the tenant improvement allowance (“Basic Allowance”) is being amortized on a straight-line basis over the initial term of the lease. The remaining $237,780 (“Additional Allowance”) represents a repayable allowance, collateralized with a letter of credit, which is being repaid over 10 years with interest at 10% per annum at approximately $38,000 per annum. The Company is obligated to refund the unpaid portion of the Additional Allowance upon early termination of the lease. As at June 30, 2005, the Company has an unamortized balance of $908,061 (December 31, 2004 - $955,092).



CARDIOME PHARMA CORP.
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited - expressed in Canadian Dollars)

4. SHARE CAPITAL
     
(a) Authorized
     
The authorized share capital of the Company consists of an unlimited number of common shares without par value and an unlimited number of preferred shares without par value issuable in series, of which none are currently issued and outstanding.
     
(b) Issued and Outstanding

    Number of
    Common shares Shares Amount
    Balance, December 31, 2004 40,592,834 $ 131,427,488
    Issued for cash upon public offering, net of share issuance costs 9,775,000 64,586,126
    Issued for cash upon exercise of options 493,591 1,745,022
    Issued pursuant to exercise of warrants on cashless basis 3,780 -
    Reallocation of contributed surplus arising from stock-based
           compensation related to the exercise of options - 397,802
    Balance, June 30, 2005 50,865,205 $ 198,156,438

   
On March 23, 2005, the Company closed a public offering of common shares pursuant to which 8,500,000 common shares were issued at a price of $7.21 (US$6.00) per share, for gross proceeds of $61,285,000 (US$51,000,000). In addition, the Company granted the underwriters an over-allotment option to purchase 1,275,000 common shares at the offering price, exercisable during the period ending 30 days from March 18, 2005. On March 30, 2005, the over-allotment option was exercised in full and the Company issued 1,275,000 common shares at a price of $7.21 (US$6.00) per share for gross proceeds of $9,192,750. In connection with the public offering, including the exercise of the over-allotment option, the Company paid a cash commission of $4,581,054 and incurred total legal and professional fees of $1,310,570.



CARDIOME PHARMA CORP.
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited - expressed in Canadian Dollars)

4. SHARE CAPITAL (CONT’D)
     
(c) Common Share Purchase Warrants
     
Details of share purchase warrant transactions for the six months ended June 30, 2005 are summarized as follows:

Number of
Warrants
    Balance, December 31, 2004 176,500
    Warrants exercised on a cashless basis (6,526 )  
    Balance, June 30, 2005 169,974

   
During the six months ended June 30, 2005, the Company issued 3,780 common shares for 6,526 warrants exercised on a cashless basis. As at June 30, 2005, common shares issuable upon the exercise of common share purchase warrants are as follows:

Exercise Number of
    Date of Expiry Price Common Shares
    February 9, 2007 US$2.40 95,269
    February 9, 2007 US$4.80 37,209
    February 9, 2007 US$8.00 37,496
    Balance, June 30, 2005 169,974

   
The above common share purchase warrants may be exercised on a cashless basis based on a formula described in the warrant agreement.



CARDIOME PHARMA CORP.
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited - expressed in Canadian Dollars)

4. SHARE CAPITAL (CONT’D)
     
(d) Stock Options
     
In May 2001, the shareholders approved a stock option plan (“2001 Plan”) providing for the granting of options to executive officers and directors, employees, consultants and clinical advisory board members of the Company. The shares available for issuance under the 2001 Plan generally vest over periods up to 5 years with a term of six years. In May 2004, the shareholders approved an amendment to the 2001 Incentive Stock Option Plan to (i) increase the maximum aggregate number of Common Shares issuable under the 2001 Incentive Stock Option Plan from 5,500,000 Common Shares to 6,000,000 Common Shares and (ii) to change the period during which optionees may exercise options after ceasing to be an eligible person. In June 2005, the shareholders approved further amendment to the 2001 Incentive Stock Option Plan to (i) decrease the maximum aggregate number of Common Shares issuable under the 2001 Incentive Stock Option Plan from 6,000,000 Common Shares to 5,750,000 Common Shares; (ii) to eliminate default vesting schedule applicable if no other vesting schedule is prescribed by the Board of Directors at the time of grant and specify that the Board of Directors may determine such vesting terms at its discretion; (iii) to restrict the maximum number of stock options issuable to insiders to 10% of the issued and outstanding Common Shares of the Company.
     
At June 30, 2005, the Company had 5,127,152 stock options outstanding, of which 3,563,021 are exercisable at a weighted average exercise price of $4.27 per common share and expiring at various dates from March 17, 2006 to July 4, 2011.
 
Details of the stock option transactions for the six months ended June 30, 2005 are summarized as follows:

Number of Stock
Weighted Average Options
Exercise Price Outstanding
    Balance, December 31, 2004 $4.48 4,701,909
       Options granted $8.42 993,209
       Options exercised $3.54 (493,591 )  
       Options forfeited $5.15 (60,625 )  
       Options expired $7.24 (13,750 )  
    Balance, June 30, 2005 $5.32 5,127,152



CARDIOME PHARMA CORP.
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited - expressed in Canadian Dollars)

4. SHARE CAPITAL (CONT’D)
     
  (d)

Stock Options (Cont’d)

At June 30, 2005, stock options to executive officers and directors, employees, consultants and clinical advisory board members were outstanding as follows:


Options outstanding Options exercisable
June 30, 2005 June 30, 2005
Range of Number of Weighted Weighted Number of Weighted
exercise price common shares average average common average
issuable remaining exercise price shares exercise price
contractual life issuable
$ (years) $ $
  $2.80-$3.68 2,477,243 3.49 3.29 2,250,993 3.28
  $5.05-$5.96 908,450 3.09 5.26 883,450 5.26
  $6.29-$8.95 1,741,459 5.31 7.57 428,578 7.41
5,127,152 4.03 5.32 3,563,021 4.27

  (e)

Stock-based compensation

The estimated fair value of options granted from December 1, 2002 to officers, directors, employees, consultants and clinical advisory board members is amortized to expense over the vesting period. Compensation expense for the three and six months ended June 30, 2005 amounted to 1,533,324 and 3,168,980, respectively (2004: $1,029,004 and $1,651,830, respectively). For the three months ended June 30, 2005, this compensation expense has been allocated to research and development expenses of $961,452 (2004: $421,940) and general and administration expenses of $571,872 (2004: $607,064) on the same basis as for the allocations of cash compensation. For the six months ended June 30, 2005, this compensation expense has been allocated to research and development expenses of $2,392,012 (2004: $719,962) and general and administration expenses of $776,968 (2004: $931,868) on the same basis as for the allocations of cash compensation.

The weighted average fair value of stock options granted during the three and six months ended June 30, 2005 was $4.77 and $5.55, respectively (2004: $4.56 and $4.36, respectively). The estimated fair value of the stock options granted was determined using the Black-Scholes option pricing model with the following weighted-average assumptions:


Assumption For the three months ended For the six months ended
    June 30, 2005 June 30, 2004 June 30, 2005 June 30, 2004
Dividend yield 0% 0% 0% 0%
Expected volatility 73.2% 76.3% 74.3% 76.7%
Risk-free interest rate 3.19% 4.18% 3.46% 3.98%
Expected of the average life options 6 years 6 years 6 years 6 years



CARDIOME PHARMA CORP.
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited - expressed in Canadian Dollars)

5. RELATED PARTY TRANSACTION
     
The Company has incurred expenses for services provided by a law firm in which an officer is a partner. The amounts charged are recorded at their exchange amounts and are subject to normal trade terms. For the three and six months ended June 30, 2005, the Company has incurred $82,065 and $690,521 of legal fees for services provided by the legal firm respectively (2004: $nil and $nil, respectively), of which $15,135 and $568,495 of the total amount incurred during the three and six months ended June 30, 2005 respectively, was in connection with the public offering completed in March 2005. Included in accounts payable and accrued liabilities at June 30, 2005 is an amount of $76,033 (December 31, 2004 - $54,688) owing to law firm.
     
6.
CONTINGENCIES
     
(a)
The Company has 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.
     
(b)
The Company has entered into license and research agreements with third parties that include indemnification provisions that are customary in the industry. These guarantees 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. To date, 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.



CARDIOME PHARMA CORP.
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited - expressed in Canadian Dollars)

7. RECONCILIATION OF GENERALLY ACCEPTED ACCOUNTING PRINCIPLES
   
The Company prepares its consolidated financial statements in accordance with Canadian GAAP, which, as applied in these unaudited interim consolidated financial statements, conform in all material respects to U.S. GAAP, except for the differences below as more fully described in Note 17 in the Company’s audited consolidated financial statements for the year ended December 31, 2004.
 
Material variations impacting the interim Consolidated Statements of Loss and Deficit under U.S. GAAP would be as follows:

    For the three months ended For the six months ended  
June 30, 2005 June 30, 2004 June 30, 2005   June 30, 2004
           
  Net loss for the period , Canadian GAAP (7,658,127 ) (9,841,059 ) (15,265,976 ) (14,567,879 )
  Amortization of other assets - (25,680 ) (8,560 ) (51,360 )
  Net loss for the period, U.S. GAAP (7,658,127 ) (9,866,739 ) (15,274,536 ) (14,619,239 )
  Reclassification adjustment for unrealized gains
     on short-term investments - (142,766 ) - (131,099 )
  Unrealized gains (losses) on short-term
     investments 25,640 (237,514 ) 25,640 (46,131 )
  Comprehensive loss for the period, U.S. GAAP (7,632,487 ) (10,247,019 ) (15,248,896 ) (14,796,469 )
  Basic and diluted loss per common share, U.S.
  GAAP (0.15 ) (0.25 ) (0.33 ) (0.38 )
  Weighted average number of common shares
  outstanding, U.S. GAAP 50,848,832 39,402,360 46,301,517 38,484,128
           
  Material variations in balance sheet accounts under U.S. GAAP are as follows:

June 30, December 31,
2005 2004
       
  Short-term investments 46,172,833 16,693,319
  Intangible and other assets 24,284,236 25,859,632
  Contributed surplus / other comprehensive income 9,887,832 7,116,654
  Deficit (108,245,697 ) (92,971,161 )
       
  Accounts payable and accrued liabilities comprise:
       
June 30, December 31,  
2005 2004  
$
       
  Trade accounts payable 2,789,834   2,966,237  
  Accrued contract research 5,317,501   2,005,022  
  Employee-related accruals 258,999 605,000  
  Other accrued liabilities 322,990 257,715  
    8,689,324 5,833,974



CARDIOME PHARMA CORP.
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited - expressed in Canadian Dollars)

7.

RECONCILIATION OF GENERALLY ACCEPTED ACCOUNTING PRINCIPLES (Continued)

Pro forma information - Stock-based compensation

The following pro forma financial information presents the net loss for the period and basic and diluted loss per common share had the Company recognized stock-based compensation for stock options granted to employees and directors using a fair value based method for all stock-based transactions prior to December 1, 2002 (see note 4(e)). For stock options granted in 2001, the fair value for these options was estimated at the date of grant using the Black-Scholes option pricing model with the following weighted-average assumptions: dividend yield - 0%; expected volatility - 88.1%; risk-free interest rate - 3.0%; and expected average life of the options - 6 years. For stock options granted during the three and six months ended June 30, 2005 and June 30, 2004, see note 4[e].

Applying the above, supplemental disclosure of pro forma net loss and loss per share is as follows:


For the three months ended For the six months ended
June 30, 2005 June 30, 2004 June 30, 2005 June 30, 2004
  Net loss for the period , U.S. GAAP (7,658,127 ) (9,866,739 ) (15,274,536 ) (14,619,239 )
  Deduct: Stock-based employee compensation
           expense included in reported loss above 1,533,324 1,029,004 3,168,980 1,651,830
  Add: Total stock-based employee compensation
           expense using fair value based method for
           all awards (1,570,324 ) (1,144,604 ) (3,242,980 ) (1,883,030 )
  Pro forma loss for the period (7,695,127 ) (9,982,339 ) (15,348,536 ) (14,850,439 )
     As reported (0.15 ) (0.25 ) (0.33 ) (0.38 )
     Pro forma (0.15 ) (0.25 ) (0.33 ) (0.39 )
           
  Other recent pronouncements

 
In December 2004, the Financial Accounting Standards Board issued SFAS 123(R) “Share-Based Payment”, a revision to SFAS 123 “Accounting for Stock Based Compensation”. SFAS 123(R) requires all share-based payments to be recognized in the financial statements based on their fair values using either a modified-prospective or modified-retrospective transition method. The standard no longer permits pro forma disclosure or the prospective recognition adopted by the Company in fiscal 2003. Accordingly, from the date of adoption of the revised standard, the Company will be required to recognize compensation expense for all share-based payments based on grant-date fair value, including those granted, modified or settled prior to December 1, 2002. However, had the Company adopted SFAS 123(R) in prior periods, the impact of the standard would have approximated the impact of SFAS 123 as described in the disclosure of pro forma loss for the period and loss per common share in the table above.
   
8.

SEGMENTED INFORMATION

The Company operates in one business segment with all of its assets and operations located in Canada, except for intellectual property with a net book value of approximately $23,000,000 [December 31, 2004 –approximately $25,000,000] located in the U.S. During the three and six months ended June 30, 2005, 100% of the Company’s revenue was derived from one research collaborator in the United States. [three months ended June 30, 2004 – 100% from one collaborator in United States; six months ended June 30, 2004 – 89% and 11% from one collaborator in each of United States and Switzerland respectively]. At June 30, 2005, included in amounts receivable is an amount of $5,376,578 (US$4,387,611) due from one research collaborator [December 31, 2004 - $13,847,269 (US$11,520,191)].



EX-99.6 7 exhibit99-6.htm CERTIFICATION OF FILINGS FROM THE CFO DATED AUGUST 11, 2005 Filed by Automated Filing Services Inc. (604)609-0244 - Cardiome Pharma Corp. - Exhibit 99.6

Form 52-109FT2 – Certification of Interim Filings during Transition Period

I, Douglas G. Janzen, Chief Financial Officer of Cardiome Pharma Corp., certify that:

1.
I have reviewed the interim filings (as this term is defined in Multilateral Instrument 52- 109 Certification of Disclosure in Issuers’ Annual and Interim Filings) of Cardiome Pharma Corp. (the issuer) for the interim period ending June 30, 2005;
   
2.
Based on my knowledge, 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; and
   
3.
Based on my knowledge, the interim financial statements together with the other financial information included in the interim filings fairly present in all material respects the financial condition, results of operations and cash flows of the issuer, as of the date and for the periods presented in the interim filings.

Date: August 11, 2005

“Doug Janzen”

_________________________________
Douglas G. Janzen
Chief Financial Officer


EX-99.7 8 exhibit99-7.htm CERTIFICATION OF FILINGS FROM THE CEO DATED AUGUST 11, 2005 Filed by Automated Filing Services Inc. (604)609-0244 - Cardiome Pharma Corp. - Exhibit 99.7

Form 52-109FT2 – Certification of Interim Filings during Transition Period

I, Robert W. Rieder, President and Chief Executive Officer of Cardiome Pharma Corp., certify that:

1.
I have reviewed the interim filings (as this term is defined in Multilateral Instrument 52- 109 Certification of Disclosure in Issuers’ Annual and Interim Filings) of Cardiome Pharma Corp. (the issuer) for the interim period ending June 30, 2005;
   
2.
Based on my knowledge, 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; and
   
3.
Based on my knowledge, the interim financial statements together with the other financial information included in the interim filings fairly present in all material respects the financial condition, results of operations and cash flows of the issuer, as of the date and for the periods presented in the interim filings.

Date: August 11, 2005

“Bob Rieder”

_________________________________
Robert W. Rieder
President and Chief Executive Officer


EX-99.8 9 exhibit99-8.htm CONFIRMATION OF MAILING DATED AUGUST 12, 2005 Filed by Automated Filing Services Inc. (604)609-0244 - Cardiome Pharma Corp. - Exhibit 99.8
6190 Agronomy Road, 6th Floor
Vancouver, BC V6T 1Z3
Tel: 604 677 6905 Fax: 604 677 6915
Email: admin@Cardiome.com


August 12, 2005

VIASEDAR

British Columbia Securities Commission
Alberta Securities Commission
Saskatchewan Financial Services Commission
Manitoba Securities Commission
Ontario Securities Commission
Commissions des valeurs mobilieres du Quebec
New Brunswick Securities Administration Branch
Securities Commission of Newfoundland and Labrador
Nova Scotia Securities Commission
Prince Edward Island Securities Commission
Yukon Registrar of Securities

Attention: Statutory Filings

Dear Sir/Madame:

Re: Cardiome Pharma Corp. (the “Company”) – Filing of Interim Financial Statement

We confirm that the interim financial statements for the quarter ended June 30, 2005 were sent to each of the persons listed on the Company’s mailing list maintained in accordance with National Policy 41 on August 12, 2005.

If you have any questions, please contact the undersigned.

Yours truly,
Cardiome Pharma Corp.

“Christina Yip”

Christina Yip
Vice President, Finance and Admin.

cc:       Toronto Stock Exchange


EX-99.9 10 exhibit99-9.htm PRESS RELEASE DATED AUGUST 15, 2005 Filed by Automated Filing Services Inc. (604)609-0244 - Cardiome Pharma Corp. - Exhibit 99.9

6190 Agronomy Rd.
6th Floor
Vancouver, BC
V6T 1Z3 CANADA

Tel: 604-677-6905
Fax: 604-677-6915
Website: www.cardiome.com

FOR IMMEDIATE RELEASE        NASDAQ: CRME TSX: COM

CARDIOME REPORTS CLINICAL RESULTS
FROM OPT-CHF STUDY

Vancouver, Canada, August 15, 2005 -- Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced results from its Phase 2 clinical trial evaluating Oxypurinol in 405 congestive heart failure (“CHF”) patients. The study, called OPT-CHF, measured the clinical impact of 600mg daily oral dosing of Oxypurinol for 24 weeks on the clinical outcomes in New York Heart Association (“NYHA”) Class 3 and Class 4 CHF patients receiving standard CHF therapy. Oxypurinol failed to demonstrate a statistically significant benefit over placebo in the primary composite endpoint (p=0.357) .

In addition, no benefits over placebo were observed in Minnesota CHF Quality of Life (“MQL”) index and time to acute clinical events (mortality plus re-hospitalization for heart failure) as secondary endpoints. A significant reduction in serum uric acid levels was observed in patients receiving Oxypurinol.

“We are clearly disappointed with this unequivocal negative outcome.” stated Bob Rieder, President and CEO of Cardiome Pharma Corp. “However, this well-designed and well-executed study has met its objective of providing a clear outcome measurement. We will review the data in greater detail prior to making any final decisions about the future of this program.”

OPT-CHF was designed to measure the efficacy and safety of oral oxypurinol, in addition to standard CHF treatments, in 405 New York Heart Association Class 3 and Class 4 CHF patients with ejection fractions less than or equal to 40%. The randomized, double-blind, placebo-controlled trial involved 24 weeks of daily oral dosing, with study visits every 4 weeks. The primary endpoint was a composite composed of NYHA Class; patient global heart failure (HF) status; hospitalization, emergency room, or emergent office/clinic visit for worsening HF; administration of a new drug class for HF or IV diuretics for worsening HF; permanent withdrawal of study drug due to worsening HF; or cardiovascular death. The study was initiated in March 2003, with enrolment completed in December 2004, and was carried out in 53 centers in the U.S. and Canada.

About Heart Failure
CHF is the failure of the heart to pump blood at a rate sufficient to support the body’s needs. This condition affects nearly 5 million people in the U.S., representing a significant public health burden. The medical burden of CHF is further reflected in the associated one-year and five-year mortality rates of approximately 20% and >50%, respectively, as well as annual expenditures estimated at nearly $28 billion [source: Heart Disease & Stroke Statistics - 2005 Update – American Heart Association]. Current drugs for CHF are often ineffective, treating the symptoms rather than the underlying cause of the heart’s deteriorating efficiency. Without effective and safe agents, all of the above figures are forecast to increase rapidly, especially as the aging public progressively develops end-stage cardiovascular disease.

About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a product-focused cardiovascular drug development company with three clinical drug programs, two of which focus on atrial arrhythmia (intravenous and oral dosing) and one directed at congestive heart failure.


RSD1235 IV is the intravenous formulation of an investigational drug being evaluated for the acute treatment of recent-onset atrial fibrillation (AF). RSD1235 also has a potential application as a chronic-use oral drug for the maintenance of normal heart rhythm following termination of AF. Top-line results from ACT 1, the first of three Phase 3 trials for RSD1235 IV, were released in December 2004 and February 2005.

Cardiome recently completed a Phase 2 clinical trial evaluating the safety and effectiveness of oxypurinol, a xanthine oxidase inhibitor, for the treatment of congestive heart failure (CHF). CHF is the failure of the heart to pump blood at a rate sufficient to support the body's needs. Top-line results from this trial were negative. Cardiome is in the process of analyzing the entire data package from the trial prior to making any decision regarding the program.

Cardiome is traded on the Toronto Stock Exchange (COM) and the NASDAQ National Market (CRME). Further information about Cardiome can be found at www.cardiome.com.

For Further Information:
Don Graham Peter K. Hofman
Director of Corporate Communication Director of Investor Relations
(604) 676-6963 or Toll Free: 1-800-330-9928 (604) 676-6993
Email: dgraham@cardiome.com Email: phofman@cardiome.com

Forward-Looking Statement Disclaimer
Statements contained in this news release relating to future results, events and expectation are forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievement of the company, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such statements. Such factors include, among others, those described in the Company's annual report on Form 40-F. The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this release.


EX-99.10 11 exhibit99-10.htm MATERIAL CHANGE REPORT DATED AUGUST 15, 2005 Filed by Automated Filing Services Inc. (604)609-0244 - Cardiome Pharma Corp. - Exhibit 99.10

FORM 53-901F

SECURITIES ACT

MATERIAL CHANGE REPORT UNDER
SECTION 85(1) OF THE SECURITIES ACT (BRITISH COLUMBIA)
AND EQUIVALENT LEGISLATION OF OTHER JURISDICTIONS

Item 1.
REPORTING ISSUER
 
Cardiome Pharma Corp.
6190 Agronomy Road, 6th Floor
Vancouver, BC V6T 1Z3
 
Item 2.
DATE OF MATERIAL CHANGE
   
 
August 15, 2005
   
Item 3.
PRESS RELEASE
 
August 15, 2005 – Vancouver, British Columbia
   
Item 4.
SUMMARY OF MATERIAL CHANGE
 
Cardiome Pharma Corp. announced results from its Phase 2 clinical trial evaluating Oxypurinol in 405 congestive heart failure (“CHF”) patients.
   
Item 5.
FULL DESCRIPTION OF MATERIAL CHANGE
 
See attached press release.
   
Item 6.
RELIANCE ON SECTION 85(2) OF THE SECURITIES ACT (BRITISH COLUMBIA) AND EQUIVALENT LEGISLATION OF OTHER JURISDICTIONS
 
Not Applicable.
   
Item 7.
OMITTED INFORMATION
 
Not Applicable.
   
Item 8.
SENIOR OFFICER
 
Name:                    Christina Yip
Title:                      Vice President, Finance and Administration
Phone No.:            604-677-6905
   
Item 9.
STATEMENT OF SENIOR OFFICER
 
The foregoing accurately discloses the material change referred to herein.


Dated at Vancouver, British Columbia, this 15th day of August, 2005.

  CARDIOME PHARMA CORP.
     
  Per:  
   
   

Christina Yip,
Vice President, Finance and Administration

IT IS AN OFFENCE FOR A PERSON TO MAKE A STATEMENT IN A DOCUMENT REQUIRED TO BE FILED OR FURNISHED UNDER THE ACT OR THIS REGULATION THAT, AT THE TIME AND IN THE LIGHT OF THE CIRCUMSTANCES UNDER WHICH IT IS MADE, IS A MISREPRESENTATION.


EX-99.11 12 exhibit99-11.htm PRESS RELEASE DATED AUGUST 29, 2005 Filed by Automated Filing Services Inc. (604)609-0244 - Cardiome Pharma Corp. - Exhibit 99.11

6190 Agronomy Rd.
6th Floor
Vancouver, BC
V6T 1Z3 CANADA

Tel: 604-677-6905
Fax: 604-677-6915
Website: www.cardiome.com

FOR IMMEDIATE RELEASE        NASDAQ: CRME TSX: COM

CARDIOME ANNOUNCES LETTER OF INTENT
TO ACQUIRE ARTESIAN THERAPEUTICS

Vancouver, Canada, August 29, 2005 -- Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) announced today that it has executed a letter of intent (“LOI”) to acquire Artesian Therapeutics, Inc., a privately held U.S. biopharmaceutical company. Headquartered in Gaithersburg, Maryland, Artesian was founded in March of 2002 to discover and develop bi-functional small-molecule drugs for the treatment of cardiovascular disease.

Artesian currently has two advanced small molecule discovery programs in the area of congestive heart failure (“CHF”). Artesian’s lead program is focused on a series of dual-pharmacophore compounds designed to simultaneously inhibit the cardiac phosphodiesterase enzyme (PDE3), causing inotropic effects, while inhibiting the L-Type Calcium channel to protect against calcium overload. Artesian’s second program focuses on a novel strategy to attenuate the deleterious effects of the excessive neurohormonal activation which occurs in congestive heart failure (CHF).

Under the terms of the proposed acquisition, payments to Artesian shareholders are contingent on the achievement of certain pre-defined clinical milestones. The milestone payments will equal, in the aggregate, US$32 million for each of the first two drug candidates from the Artesian programs that reach NDA approval. The first such milestone is due upon initiation of the clinical development of an Artesian drug candidate. Concurrent with closing of the proposed acquisition, Oxford Bioscience Partners, Artesian’s largest shareholder, will invest US$7.5 million into Cardiome at a price of approximately US$7.24 per share, a 5% premium over the five day average closing price of the common shares of Cardiome on the NASDAQ Stock Market prior to the execution of the LOI.

"This acquisition reflects Cardiome’s objective of expanding our product pipeline in the cardiology arena.” said Bob Rieder, President and CEO of Cardiome. “Artesian’s drug development candidates reflect an innovative drug discovery strategy which has been well implemented. We are excited at the potential to obtain several such high-potential drug candidates from this acquisition, along with the financial resources required to drive that development.”

The completion of this transaction is subject to a number of conditions, including satisfactory completion of due diligence, final board approval, settling and executing definitive documentation, regulatory approval and customary closing conditions, and is expected to close in October, 2005.

About Artesian Therapeutics, Inc.
Artesian Therapeutics, Inc. is a privately-held biopharmaceutical company discovering and developing a new generation of novel disease modifying therapeutics for the treatment of cardiovascular disease (CVD), by far the leading cause of death in the North America. Artesian is committed to revolutionizing the treatment of CVD utilizing a unique integrated technology approach to discover relevant disease pathways and rapidly translate these discoveries into therapeutic strategies to slow the progression of CVD, and promote the repair and recovery of the diseased heart.


About Oxford Bioscience Partners
Oxford Bioscience Partners (OBP) is a life science venture capital firm that provides equity financing and management assistance to start-up early-stage, entrepreneurial-driven companies in the bioscience and healthcare industries. The General Partners of OBP currently manage venture funds with combined committed capital of more than $800 million. Oxford Bioscience Partners has achieved considerable success and above average returns in the bioscience field over the past 20 years through investments in more than 100 companies worldwide. More information on Oxford Bioscience Partners is available at www.oxbio.com.

About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a product-focused cardiovascular drug development company with three clinical drug programs, two of which focus on atrial arrhythmia (intravenous and oral dosing) and one directed at congestive heart failure.

RSD1235 IV is the intravenous formulation of an investigational drug being evaluated for the acute treatment of recent-onset atrial fibrillation (AF). RSD1235 also has a potential application as a chronic-use oral drug for the maintenance of normal heart rhythm following termination of AF. Top-line results from ACT 1, the first of three Phase 3 trials for RSD1235 IV, were released in December 2004 and February 2005.

Cardiome recently completed a Phase 2 clinical trial evaluating the safety and effectiveness of oxypurinol, a xanthine oxidase inhibitor, for the treatment of congestive heart failure (CHF). CHF is the failure of the heart to pump blood at a rate sufficient to support the body's needs. Top-line results from this trial were negative. Cardiome is in the process of analyzing the entire data package from the trial prior to making any decision regarding the program.

Cardiome is traded on the Toronto Stock Exchange (COM) and the NASDAQ National Market (CRME). Further information about Cardiome can be found at www.cardiome.com.

For Further Information:
Don Graham Peter K. Hofman
Director of Corporate Communication Director of Investor Relations
(604) 676-6963 or Toll Free: 1-800-330-9928 (604) 676-6993
Email: dgraham@cardiome.com Email: phofman@cardiome.com

Forward-Looking Statement Disclaimer
Statements contained in this news release relating to future results, events and expectation are forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievement of the company, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such statements. Such factors include, among others, those described in the Company's annual report on Form 40-F. In addition, the closing of the transaction contemplated by this release is conditional upon a number of factors, many of which are outside the Company’s control. There is no assurance that the transaction will be completed at all or upon the same terms and conditions described above. The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this release.


EX-99.12 13 exhibit99-12.htm MATERIAL CHANGE REPORT DATED AUGUST 29, 2005 Filed by Automated Filing Services Inc. (604)609-0244 - Cardiome Pharma Corp. - Exhibit 99.12

FORM 53-901F
SECURITIES ACT

MATERIAL CHANGE REPORT UNDER
SECTION 85(1) OF THE SECURITIES ACT (BRITISH COLUMBIA)
AND EQUIVALENT LEGISLATION OF OTHER JURISDICTIONS

Item 1.
REPORTING ISSUER
 
Cardiome Pharma Corp.
6190 Agronomy Road, 6th Floor
Vancouver, BC V6T 1Z3
   
Item 2.
DATE OF MATERIAL CHANGE
 
August 29, 2005
   
Item 3.
PRESS RELEASE
 
August 29, 2005 – Vancouver, British Columbia
   
Item 4.
SUMMARY OF MATERIAL CHANGE
 
Cardiome Pharma Corp. announced that it has executed a letter of intent (“LOI”) to acquire Artesian Therapeutics, Inc., a privately held U.S. biopharmaceutical company.
   
Item 5.
FULL DESCRIPTION OF MATERIAL CHANGE
 
See attached press release.
   
Item 6.
RELIANCE ON SECTION 85(2) OF THE SECURITIES ACT (BRITISH COLUMBIA) AND EQUIVALENT LEGISLATION OF OTHER JURISDICTIONS
 
Not Applicable.
   
Item 7.
OMITTED INFORMATION
 
Not Applicable.
   
Item 8.
SENIOR OFFICER
 
Name:                    Christina Yip
Title:                      Vice President, Finance and Administration
Phone No.:            604-677-6905
   
Item 9.
STATEMENT OF SENIOR OFFICER
 
The foregoing accurately discloses the material change referred to herein.


Dated at Vancouver, British Columbia, this 2nd day of September, 2005.

  CARDIOME PHARMA CORP.
     
  Per:  
   
   

Christina Yip,
Vice President, Finance and Administration

IT IS AN OFFENCE FOR A PERSON TO MAKE A STATEMENT IN A DOCUMENT REQUIRED TO BE FILED OR FURNISHED UNDER THE ACT OR THIS REGULATION THAT, AT THE TIME AND IN THE LIGHT OF THE CIRCUMSTANCES UNDER WHICH IT IS MADE, IS A MISREPRESENTATION.


EX-99.13 14 exhibit99-13.htm PRESS RELEASE DATED AUGUST 31, 2005 Filed by Automated Filing Services Inc. (604)609-0244 - Cardiome Pharma Corp. - Exhibit 99.13


6190 Agronomy Rd.
6th Floor
Vancouver, BC
V6T 1Z3 CANADA

Tel: 604-677-6905
Fax: 604-677-6915
Website: www.cardiome.com

FOR IMMEDIATE RELEASE        NASDAQ: CRME TSX: COM

CARDIOME SUCCESSFULLY COMPLETES
RSD1235 ORAL PHASE 1 TRIAL

Vancouver, Canada, August 31, 2005 -- Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced that it has successfully completed the Phase 1 studies required to advance oral RSD1235 into a planned Phase 2 study later this year. The most recently completed study evaluated the pharmacokinetics (PK), safety and tolerability of orally-administered RSD1235 over 7 days of repeat dosing within an escalating dose regimen.

The study’s trial design tested the upper limits of tolerability in 55 healthy volunteers, including extensive metabolizers and poor metabolizers. Orally-administered RSD1235 was found to be safe and well-tolerated across all dose levels. The maximum dose given for 7 days was 900mg twice daily (1,800mg/day), yielding blood levels of RSD1235 approaching peak blood levels seen in IV dosing. The formulation provided sustained high blood levels of drug over an interval deemed suitable for chronic-use oral therapy. No clinically relevant changes were found in clinical laboratory, vital signs or ECG measurements, and there were no serious adverse events.

“Our Phase 1 program has indicated that oral RSD1235 can be administered safely at clinically relevant dose levels.” stated Charles Fisher M.D., Cardiome’s Chief Medical Officer. “We have seen in our intravenous (IV) trials that RSD1235 appears to be effective in converting atrial arrhythmia. Since repeat-dose safety is the major barrier to chronic use of anti-arrhythmic drugs, the strong performance of RSD1235 in these safety studies is very encouraging.”

Multiple Phase 2 studies in patients with atrial arrhythmia are currently envisioned. The first study, to be initiated in the 4th quarter of 2005, will be a pilot study to determine appropriate enrolment criteria, safety, and tolerability of 28-day oral dosing of RSD1235 in up to 120 atrial fibrillation patients. Two RSD1235 dosing groups and a placebo group will be included. Details regarding the design of following studies will be released later this year.

“In a medical arena where cardiovascular safety is all-important, the safety and tolerability results from this study are highly encouraging.” said Bob Rieder, President and CEO of Cardiome Pharma. “We can now look forward to advancing oral RSD1235 into the next stage of clinical development.”

Orally-administered RSD1235 is designed to be used as chronic therapy to prevent or delay the reoccurrence of atrial fibrillation, and could be used as a follow-on therapy to intravenous RSD1235, currently in its second and third Phase 3 trials for acute conversion of atrial fibrillation.

About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a product-focused cardiovascular drug development company with three clinical drug programs, two of which focus on atrial arrhythmia (intravenous and oral dosing) and one directed at congestive heart failure.

RSD1235 IV is the intravenous formulation of an investigational drug being evaluated for the acute treatment of recent-onset atrial fibrillation (AF). RSD1235 also has a potential application as a chronic-use oral drug for


the maintenance of normal heart rhythm following termination of AF. Top-line results from ACT 1, the first of three Phase 3 trials for RSD1235 IV, were released in December 2004 and February 2005.

Cardiome recently completed a Phase 2 clinical trial evaluating the safety and effectiveness of oxypurinol, a xanthine oxidase inhibitor, for the treatment of congestive heart failure (CHF). CHF is the failure of the heart to pump blood at a rate sufficient to support the body's needs. Top-line results from this trial were negative. Cardiome is in the process of analyzing the entire data package from the trial prior to making any decision regarding the program.

Cardiome recently announced that it has executed a letter of intent to acquire Artesian Therapeutics Inc., a privately held U.S. biopharmaceutical company developing bi-functional small-molecule drugs for the treatment of cardiovascular disease.

Cardiome is traded on the Toronto Stock Exchange (COM) and the NASDAQ National Market (CRME). Further information about Cardiome can be found at www.cardiome.com.

For Further Information:
Don Graham Peter K. Hofman
Director of Corporate Communication Director of Investor Relations
(604) 676-6963 or Toll Free: 1-800-330-9928 (604) 676-6993
Email: dgraham@cardiome.com Email: phofman@cardiome.com

Forward-Looking Statement Disclaimer
Statements contained in this news release relating to future results, events and expectation are forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievement of the company, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such statements. Such factors include, among others, those described in the Company's annual report on Form 40-F. The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this release.


EX-99.14 15 exhibit99-14.htm MATERIAL CHANGE REPORT DATED AUGUST 31, 2005 Filed by Automated Filing Services Inc. (604)609-0244 - Cardiome Pharma Corp. - Exhibit 99.14

FORM 53-901F
SECURITIES ACT

MATERIAL CHANGE REPORT UNDER

SECTION 85(1) OF THE SECURITIES ACT (BRITISH COLUMBIA) AND EQUIVALENT LEGISLATION OF OTHER JURISDICTIONS

Item 1.
REPORTING ISSUER
 
Cardiome Pharma Corp.
6190 Agronomy Road, 6th Floor
Vancouver, BC V6T 1Z3
   
Item 2.
DATE OF MATERIAL CHANGE
 
August 31, 2005
   
Item 3.
PRESS RELEASE
 
August 31, 2005 – Vancouver, British Columbia
   
Item 4.
SUMMARY OF MATERIAL CHANGE
 
Cardiome Pharma Corp. announced that it has successfully completed the Phase I studies required to advance oral RSD1235 into a planned Phase 2 study later this year.
   
Item 5.
FULL DESCRIPTION OF MATERIAL CHANGE
 
See attached press release.
   
Item 6.
RELIANCE ON SECTION 85(2) OF THE SECURITIES ACT (BRITISH COLUMBIA) AND EQUIVALENT LEGISLATION OF OTHER JURISDICTIONS
 
Not Applicable.
   
Item 7.
OMITTED INFORMATION
 
Not Applicable.
   
Item 8.
SENIOR OFFICER
 
Name:                    Christina Yip
Title:                      Vice President, Finance and Administration
Phone No.:            604-677-6905
   
Item 9.
STATEMENT OF SENIOR OFFICER
 
The foregoing accurately discloses the material change referred to herein.


Dated at Vancouver, British Columbia, this 2nd day of September, 2005.

  CARDIOME PHARMA CORP.
     
  Per:  
   
   

Christina Yip,
Vice President, Finance and Administration

IT IS AN OFFENCE FOR A PERSON TO MAKE A STATEMENT IN A DOCUMENT REQUIRED TO BE FILED OR FURNISHED UNDER THE ACT OR THIS REGULATION THAT, AT THE TIME AND IN THE LIGHT OF THE CIRCUMSTANCES UNDER WHICH IT IS MADE, IS A MISREPRESENTATION.


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-----END PRIVACY-ENHANCED MESSAGE-----