0001279569-15-001056.txt : 20150514 0001279569-15-001056.hdr.sgml : 20150514 20150513185618 ACCESSION NUMBER: 0001279569-15-001056 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 7 CONFORMED PERIOD OF REPORT: 20150513 FILED AS OF DATE: 20150514 DATE AS OF CHANGE: 20150513 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Cardiome Pharma Corp CENTRAL INDEX KEY: 0001036141 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: A1 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-29338 FILM NUMBER: 15859801 BUSINESS ADDRESS: STREET 1: 6TH FLOOR STREET 2: 1441 CREEKSIDE DRIVE CITY: VANCOUVER STATE: A1 ZIP: V6J 4S7 BUSINESS PHONE: 1-604-677-6905 MAIL ADDRESS: STREET 1: 6TH FLOOR STREET 2: 1441 CREEKSIDE DRIVE CITY: VANCOUVER STATE: A1 ZIP: V6J 4S7 FORMER COMPANY: FORMER CONFORMED NAME: CARDIOME PHARMA CORP DATE OF NAME CHANGE: 20000407 6-K 1 v410524_6k.htm FORM 6-K

 

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

Report of Foreign Private Issuer

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

The Securities Exchange Act of 1934

 

For the month of May, 2015

 

COMMISSION FILE NO. 000-29338

 

CARDIOME PHARMA CORP.

(formerly NORTRAN PHARMACEUTICALS INC.)

 

____________________________________________

(Translation of Registrant’s name into English)

 

1441 Creekside Drive, 6th floor

Vancouver, British Columbia, V6J 4S7, CANADA

(Address of principal executive offices)

 

 

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

 

Form 20-F ☐ Form 40-F

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐

 

Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange act of 1934.

 

Yes ☐ No

 

This Form 6-K is hereby filed and incorporated by reference in the registrant’s Registration Statements on Form F-10 (File No. 333-137935), Form F-3 (File No. 333-131912), Form S-8 (333-136696) and Form S-8 (333-125860).

 

 

 

 

 
 

 

 

SIGNATURES

 

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  CARDIOME PHARMA CORP.
     
     
Date: May 13, 2015 /s/ JENNIFER ARCHIBALD
  Jennifer Archibald
  Chief Financial Officer

 


 
 

 

 

EXHIBIT INDEX

 

EXHIBIT   DESCRIPTION OF EXHIBIT
     
99.1  

Management’s Discussion and Analysis of Financial Condition and Results of Operations

99.2   Consolidated Financial Statements
99.3   Material Change Report dated May 13, 2015
99.4   Certificate of Filing - CEO
99.5   Certificate of Filing - CFO

 

 

 

EX-99.1 2 v410524_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

 

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION 

AND RESULTS OF OPERATIONS

 

This management discussion and analysis (“MD&A”) of Cardiome Pharma Corp. (“Cardiome”, “we”, “us” or “our”) for the three-month period ended March 31, 2015 is as of May 12, 2015. We have prepared this MD&A with reference to National Instrument 51-102 “Continuous Disclosure Obligations” of the Canadian Securities Administrators. Under the U.S./Canada Multijurisdictional Disclosure System, Cardiome is permitted to prepare this MD&A in accordance with the disclosure requirements of Canada, which are different from those of the United States. This MD&A should be read in conjunction with our interim unaudited consolidated financial statements for the three months ended March 31, 2015 and the related notes thereto. Our consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”). All amounts are expressed in U.S. dollars unless otherwise indicated.

 

This MD&A contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act and applicable Canadian securities laws regarding expectations of our future performance, liquidity and capital resources, as well as marketing plans, future revenues from sales of BRINAVESSand AGGRASTAT®, the expected completion of the transition of global rights to vernakalant to Cardiome by Merck & Co., Inc., known as Merck Sharp & Dohme (“MSD”) outside Canada and the United States, our intention to continue discussions with the U.S. Food and Drug Administration regarding potential development plans for the vernakalant programs in the United States, and other non-historical statements, which are based on our current expectations and beliefs, including certain factors and assumptions, as described in our most recent Annual Information Form, but are also subject to numerous risks and uncertainties, as described in the “Risk Factors” section of our Annual Information Form. As a result of these risks and uncertainties, or other unknown risks and uncertainties, our actual results may differ materially from those contained in any forward-looking statements. The words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We undertake no obligation to update forward-looking statements, except as required by law. Additional information relating to Cardiome, including our most recent Annual Report on Form 40-F filed with the United States Securities Exchange Commission (the “SEC”), and our most recent Annual Information Form, is available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (“SEDAR”) website at www.sedar.com or the SEC’s Electronic Document Gathering and Retrieval System (“EDGAR”) website at www.sec.gov/edgar.

 

OVERVIEW

 

We are a specialty pharmaceutical company dedicated to the development and commercialization of cardiovascular therapies that will improve the quality of life and health of patients suffering from heart disease. We strive to find innovative, differentiated medicines that provide therapeutic and economic value to patients, physicians and healthcare systems. We currently have two marketed, in-hospital cardiology products, BRINAVESSTM and AGGRASTAT®, which are commercially available in markets outside of the United States.

 

BRINAVESSTM (vernakalant (IV)) was approved in the European Union in September 2010 and is currently registered and approved in approximately 50 countries for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults (for non-surgery patients with atrial fibrillation of seven days or less) and for use in post-cardiac surgery patients with atrial fibrillation of three days or less. BRINAVESSTM is mentioned as a first-line therapy in the European Society of Cardiology atrial fibrillation guidelines for the cardioversion of recent-onset atrial fibrillation in patients with no, or minimal/moderate, structural heart disease.

 

AGGRASTAT® (tirofiban HCL) is a reversible GP IIb/IIIa inhibitor (an intravenous anti-platelet drug) for use in Acute Coronary Syndrome patients. AGGRASTAT® has been approved in numerous countries worldwide. We acquired the ex-U.S. marketing rights to AGGRASTAT® as part of the transaction in which we also acquired Correvio LLC (“Correvio”), a privately held pharmaceutical company headquartered in Geneva, Switzerland, in November 2013.

 

1
 

 

Both BRINAVESSTM and AGGRASTAT® are available commercially outside of the United States either directly through our own sales force in Europe or via our global distributor and partner network.

 

BRINAVESS™ (Vernakalant (IV))

 

We have exclusive, global marketing rights to BRINAVESSTM, the intravenous formulation of vernakalant, and are responsible for all future development and commercialization of the product, subject to ongoing transfer of certain rights from MSD and its affiliates. Transfers have been delayed in certain jurisdictions due to routine regulatory requirements but are expected to be completed in 2015.

 

North America

 

In December 2006, our former partner, Astellas Pharma US, Inc. (“Astellas”), filed a New Drug Application (“NDA”) for vernakalant (IV) with the U.S. Food and Drug Administration (“FDA”). In August 2008, Astellas received an action letter from the FDA, informing Astellas that the FDA had completed its review of the NDA for vernakalant (IV) and that the application was approvable. The letter requested additional information associated with the risk of previously identified events experienced by a subset of patients during the clinical trials as well as a safety update from ongoing or completed studies of vernakalant (IV), regardless of indication, dosage form or dose level. The action letter further indicated that if the response to their requests was not satisfactory, additional clinical studies may be required.

 

In August 2009, we, together with our former partner Astellas, announced that Astellas would undertake a single confirmatory additional Phase 3 clinical trial (“ACT 5") under a Special Protocol Assessment. The decision to conduct another trial was reached following extended discussions between Astellas and the FDA to define the best regulatory path forward for vernakalant (IV). ACT 5 began enrolment of recent onset atrial fibrillation patients without a history of heart failure in October 2009.

 

In October 2010, a clinical hold was placed on ACT 5 following a single unexpected serious adverse event of cardiogenic shock experienced by a patient with atrial fibrillation who received vernakalant (IV).

 

In July 2011, MSD entered into an agreement to acquire the rights for the development and commercialization of vernakalant (IV) in North America (the “North American Vernakalant (IV) Agreement”). All terms, responsibilities and payments that Astellas committed to under the North American Vernakalant (IV) Agreement were assumed by MSD without change. MSD and the FDA agreed to terminate ACT 5. MSD began discussions with the FDA to determine the next steps for the development of vernakalant (IV) in the United States.

 

In September 2012, MSD gave notice to us of its termination of the North American Vernakalant (IV) Agreement. In May 2013, we completed the transfer of sponsorship of the U.S. Investigational New Drugs (“INDs”) for vernakalant (IV) and vernakalant (oral) and the transfer of the NDA for vernakalant (IV) from MSD to us. We have initiated discussions with the FDA regarding potential development paths for vernakalant (IV) in the United States. The program remains on clinical hold pending agreement of a suitable development path.

 

Rest of World (Outside North America)

 

In April 2009, we entered into two collaboration and license agreements (“the Collaboration Agreements”) with MSD for the development and commercialization of vernakalant. The Collaboration Agreements provided an affiliate of MSD with exclusive rights outside of North America to vernakalant (IV).

 

2
 

 

Under the terms of the Collaboration Agreements, MSD paid us an initial fee of $60 million. In addition, we were eligible to receive up to an additional $200 million in payments, of which we received $45 million (described below), based on the achievement of certain milestones associated with the development and approval of vernakalant products. We were also eligible to receive up to $100 million for milestones associated with approvals in other subsequent indications of both the intravenous and oral formulations, and tiered royalty payments on sales of any approved products. We had the potential to receive up to $340 million in additional milestone payments based on achievement of significant sales thresholds. MSD was responsible for all costs associated with the development, manufacturing and commercialization of these product candidates.

 

In July 2009, our former partner, MSD, submitted a Marketing Authorization Application (“MAA”) to the European Medicines Agency (“EMA”) seeking marketing approval for vernakalant (IV) in the European Union, and as a result of the submission we received a $15 million milestone payment from MSD.

 

In June 2010, the Committee for Medicinal Products for Human Use of the EMA recommended marketing approval of vernakalant (IV) for the conversion of recent onset atrial fibrillation to sinus rhythm in adults and in September 2010, vernakalant (IV) received marketing approval under the trade name BRINAVESSTM in the European Union, Iceland and Norway. This milestone triggered a $30 million milestone payment from MSD. After receipt of marketing approval, MSD began its commercial launch of BRINAVESSTM in a number of European countries.

 

In September 2012, MSD gave notice to us of its termination of the Collaboration Agreements. On April 25, 2013, we entered into a transition agreement with MSD (the “Transition Agreement”) to amend and supplement the provisions of the Collaboration Agreements governing their rights and responsibilities in connection with the termination of the Collaboration Agreements and transfer of rights to, and responsibilities for, vernakalant to us. Pursuant to the Transition Agreement, we took responsibility for worldwide sales, marketing, and promotion of vernakalant (IV) on April 25, 2013. On September 21, 2013, MSD and Cardiome entered into an agreement regarding the rights and responsibilities of each party for the continued transfer of marketing authorizations. On a per country basis, regulatory and product distribution responsibilities have been transferred to us upon agencies’ approvals of marketing authorization transfers. As a result of routine regulatory requirements, the transfer has been delayed in certain jurisdictions. All applications for transfers are expected to be completed in 2015.

 

In June 2013, we announced the decision by the European Commission to allow the transfer of the centrally-approved marketing authorisation for BRINAVESSTM from MSD to us. We are now the marketing authorization holder for BRINAVESSTM in the member states of the European Union. As a result, royalties on sales and the promotional services fee we previously received from MSD ceased on July 1, 2013 and we began benefiting from all sales of BRINAVESSTM throughout the world.

 

On September 16, 2013, we announced the completion of the transfer from MSD to us of commercialization responsibility for BRINAVESSTM in the European Union and the responsibility to complete the post-marketing study for BRINAVESSTM. Since that date, we have been supplying BRINAVESSTM under our own trade dress in the European Union.

 

During 2014, we continued to seek new partners to distribute BRINAVESSTM. We entered into commercialization agreements with Tamro AB, Nomeco A/S, VIANEX S.A., UDG Healthcare PLC, Eurolab Especialidades Medicinales de Eurofar S.R.L. and Pharmacare Limited, which trades as Aspen Pharmacare and is a part of the Aspen Group, to distribute BRINAVESSTM in Sweden, Denmark, Spain, Greece, Ireland, Argentina and South Africa, respectively. In addition, we announced that our partner, AOP Orphan Pharmaceuticals AG, headquartered in Vienna, Austria, is now making BRINAVESSTM available to physicians and patients in Switzerland, the Czech Republic, Poland, Slovenia, Slovakia, Hungary, Latvia and Romania.

 

3
 

 

In November 2014, we announced results from a Phase 3 clinical study conducted with BRINAVESSTM in the Asia-Pacific region. The study originally planned to recruit 615 patients; however, the study was completed after randomising 123 patients. The study remained sufficiently powered and it achieved the primary endpoint, showing that of the 111 treated patients with recent-onset atrial fibrillation lasting three hours to seven days, 53% of those receiving an IV dose of BRINAVESSTM converted to normal heart rhythm within 90 minutes, compared to 12% of placebo patients (95% CI; 23%, 58%, p<0.001).

 

In December 2014, we entered into an agreement with Eddingpharm (Asia) Macao Commercial Offshore Limited (“Eddingpharm”) to develop and commercialize BRINAVESS™ in China, Taiwan, and Macau and to re-launch BRINAVESSTM in Hong Kong. Eddingpharm will be responsible for any clinical trials and regulatory approvals required to commercialize BRINAVESSTM in the countries covered by the agreement. Under the terms of the agreement, Eddingpharm has agreed to an upfront payment of $1 million and specific annual commercial goals for BRINAVESSTM. Cardiome is also eligible to receive regulatory milestone payments of up to $3 million.

 

Vernakalant (oral)

 

Vernakalant (oral) is being developed as an oral maintenance therapy for the long-term prevention of atrial fibrillation recurrence. In July and September 2006, we announced positive top line results for the sequential 300 mg and 600 mg dosing groups, respectively, from the Phase 2a pilot study of vernakalant (oral). In July 2008, we announced positive clinical results from the Phase 2b clinical study of vernakalant (oral) to further evaluate the safety and tolerability, pharmacokinetics and efficacy of vernakalant (oral).

 

In April 2009, we entered into the Collaboration Agreements with MSD for the development and commercialization of vernakalant, which provided an affiliate of MSD with exclusive global rights to vernakalant (oral).

 

In November 2011, MSD completed an additional multiple rising-dose Phase I study to explore the safety, tolerability, pharmacokinetics and pharmacodynamics of higher doses of vernakalant (oral) than previously studied in healthy subjects. In this study, vernakalant (oral) was well-tolerated at increased exposures. We also announced that MSD had scheduled, to start in late 2011, an additional Phase I trial assessing the safety and tolerability of vernakalant (oral) when dosed for a more extended period of time at higher exposures.

 

In March 2012, MSD informed us of its decision to discontinue further development of vernakalant (oral). In September 2012, we announced that MSD would return the global marketing and development rights for vernakalant (oral) to us in connection with MSD’s termination of the Collaboration Agreements. In May 2013, we completed the transfer of sponsorship of the IND for vernakalant (oral) from MSD to us. We are continuing to assess the appropriate development plan for vernakalant (oral).

 

4
 

 

AGGRASTAT® for Acute Coronary Syndrome

 

AGGRASTAT® contains tirofiban hydrochloride, which is a reversible GP IIb/IIIa inhibitor for use in indicated Acute Coronary Syndrome patients. AGGRASTAT® is used to help assist the blood flow to the heart and to prevent chest pain and/or heart attacks (both STEMI – ST-elevation myocardial infarction, and NONSTEMI – non-ST-elevation myocardial infarction). It works by preventing platelets, cells found in the blood, from forming into blood clots within the coronary arteries and obstructing blood flow to the heart muscle which can result in a heart attack. The medicine may also be used in patients whose heart vessels are dilated with a balloon (percutaneous coronary intervention or PCI, a procedure used to open up blocked or obstructed arteries in the heart in order to improve the blood flow to the heart muscle (myocardium) with or without the placement of a coronary stent. AGGRASTAT® is administered intravenously, and has been on the market for many years with an excellent safety and efficacy profile.

 

In May 2014, we entered into an agreement with AOP Orphan Pharmaceuticals AG to commercialize AGGRASTAT® in selected European markets. Key countries for AGGRASTAT® include Austria, Hungary, Switzerland, and other Eastern European states.

 

Pre-Clinical

 

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

 

The following table summarizes the current status of our programs:

 

Program   Stage of Development   Current Status
Vernakalant (IV)   FDA NDA   Approvable letter received in 2008
         
    EMA MAA   Marketing approval received in September 2010 under trade name BRINAVESSTM
         
    European Comparator (AVRO) Study   Final results released in Q2-2010
         
    Phase 3 Asia Pacific study   Results released November 2014
         
    ACT 5   Study terminated
         
    Post approval study   SPECTRUM (post approval safety study) initiated in Q4-2011  
        Study continuing
5
 

 

Program   Stage of Development   Current Status
Vernakalant (oral)   Phase 2b Clinical Trial   Final results released in Q3-2008
         
    Pharmacokinetic/ pharmacodynamics studies  

Phase 1 PK/PD studies completed

 

CORPORATE UPDATE

 

At-The-Market Sales Issuance Agreement

 

On February 18, 2014, we filed a prospectus supplement in each of the provinces of Canada, other than Québec, and the United States to qualify and register the distribution of our common shares having an aggregate offer price of up to $8.9 million in “at-the-market” distributions effected from time to time pursuant to an At-The-Market Sales Issuance Agreement that we entered into on the same day with MLV & Co. LLC, as agent (the “ATM Offering”). No sales in the ATM Offering will be made in Canada. During the three months ended March 31, 2015, we issued 88,467 of our common shares in the ATM Offering for gross proceeds of $0.9 million.

 

As stated in the prospectus supplement pursuant to which the ATM Offering financing is effected, we intend to use the net proceeds from the sale of the common shares offered in the ATM Offering primarily for working capital and general corporate purposes, including to fund expansion of our sales and marketing efforts for BRINAVESSTM and AGGRASTAT® in Europe and other parts of the world, for funding clinical development and regulatory costs of vernakalant (IV) and vernakalant (oral), and for advancement of our other business objectives outlined under “Our Strategy” in the base shelf prospectus, dated February 13, 2014, pursuant to which the ATM Offering is affected. The majority of the proceeds we have received from the ATM Offering were used for selling, general and administration expenses.

 

Commercialization Agreement for ESMOCARD® and ESMOCARD LYO®

 

On May 12, 2015, we entered into a commercialization agreement with AOP to sell cardiovascular products, ESMOCARD® and ESMOCARD LYO® (esmolol hydrochloride) in Italy, France, Spain and Belgium. The addition of the ESMOCARD® franchise increases our offering of cardiovascular products in these four countries. ESMOCARD® is indicated for supraventricular tachycardia (except for pre-excitation syndromes) and for the rapid control of the ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other circumstances where short-term control of the ventricular rate with a short-acting agent is desirable. ESMOCARD® is also indicated for tachycardia and hypertension occurring in the perioperative phase and non-compensatory sinus tachycardia where, in the physician's judgement the rapid heart rate requires specific intervention. ESMOCARD® is not intended for use in chronic settings. ESMOCARD® is available in two presentations including a 10mg/ml 10ml solution for injection (branded as ESMOCARD®) and a 2500mg powder for concentrate for solution for infusion (branded as ESMOCARD LYO®).

 

6
 

 

SELECTED CONSOLIDATED FINANCIAL INFORMATION

 

The following table sets forth selected consolidated financial information for and as at the three months ended March 31, 2015 and 2014 as follows:

 

(In thousands of U.S. dollars, except as  Three months ended March 31, 
otherwise stated)  2015   2014 
Statement of operations data:        
Revenue  $5,497   $7,592 
Operating loss   (2,657)   (2,681)
Net loss   (3,887)   (3,134)
           
Loss per share – basic and diluted (in dollars)  $(0.23)  $(0.20)

 

   As at 
   March 31, 2015   December 31, 2014 
Balance sheet data:          
Total assets  $42,652   $50,115 
Long-term debt, including current portion   12,000    12,000 
Deferred consideration, including current portion   7,099    7,588 

 

RESULTS OF OPERATIONS

 

Three Months Ended March 31, 2015 Compared to Three Months Ended March 31, 2014

 

We recorded a net loss of $3.9 million (loss per common share of $0.23) for the three months ended March 31, 2015, compared to a net loss of $3.1 million (loss per common share of $0.20) for the three months ended March 31, 2014.

 

Revenue

 

Revenue for the three months ended March 31, 2015 was $5.5 million, compared to revenue of $7.6 million for the three months ended March 31, 2014. The decrease was due primarily to timing of distributor sales, a decrease in AGGRASTAT® sales due to generic competition, and foreign exchange.

 

Cost of Goods Sold

 

Cost of goods sold for the three months ended March 31, 2015 was $1.2 million, compared to cost of goods sold of $1.5 million for the three months ended March 31, 2014. Cost of goods sold relates to the sale of AGGRASTAT® and BRINAVESSTM.

 

Selling, General and Administration Expense

 

Selling, general and administration (“SG&A”) expense for the three months ended March 31, 2015 was $6.3 million, compared to SG&A expense of $8.0 million for the three months ended March 31, 2014. The decrease was due primarily to the reversal of certain one-off expenditures accrued in prior quarters, one-time costs incurred in the prior year related to the acquisition of Correvio, and foreign exchange.

 

7
 

 

Other expense

 

Other expense increased to $1.1 million for the three months ended March 31, 2015 from $0.3 million for the three months ended March 31, 2014. This is primarily due to interest expense incurred on the senior secured term loan facility. We entered into this term loan facility in July 2014.

 

QUARTERLY FINANCIAL INFORMATION

 

The following table highlights selected unaudited consolidated financial information for each of the eight most recent quarters that, in management’s opinion, have been prepared on a basis consistent with the audited consolidated financial statements for the year ended December 31, 2014. The selected financial information presented below reflects all adjustments, consisting primarily of normal recurring adjustments, which are, in the opinion of management, necessary for a fair presentation of results for the interim periods. These results are not necessarily indicative of results for any future period and you should not rely on these results to predict future performance.

 

   Three months ended 
(In thousands of U.S. dollars
except per share amounts)
  March 31,
2015
   December 31,
2014
   September 30,
2014
   June 30,
2014
 
                 
Revenue  $5,497   $6,976   $7,807   $7,667 
Cost of goods sold   1,224    3,618    2,673    2,243 
Selling, general and administration   6,327    9,143    7,863    8,808 
Research and development   62    99    234    59 
Interest expense   674    508    495    226 
Net loss  $(3,887)  $(6,486)  $(4,367)  $(4,240)
Loss per share – basic and diluted  $(0.23)  $(0.39)  $(0.26)  $(0.26)

 

   Three months ended 
(In thousands of U.S. dollars
except per share amounts)
  March 31,
2014
   December 31,
2013
   September 30,
2013
   June 30,
2013
 
                 
Revenue  $7,592   $3,867   $477   $107 
Cost of goods sold   1,493    889    47    - 
Selling, general and administration   7,999    7,282    3,954    2,974 
Research and development   245    40    31    35 
Interest expense   254    -    -    - 
Restructuring   -    1,337    -    (57)
Net loss  $(3,134)  $(7,232)  $(3,614)  $(2,774)
Loss per share – basic and diluted  $(0.20)  $(0.53)  $(0.29)  $(0.22)

 

8
 

 

Variations in our revenue, expense and net loss for the periods above resulted primarily from the following factors:

 

In the second quarter of 2014, our net loss increased to $4.2 million, or loss of $0.26 per common share. The increase was primarily due to an increase in SG&A expense due to costs incurred to support the commercialization of BRINAVESSTM and the continued sales of AGGRASTAT®.

 

In the third quarter of 2014, our net loss increased by $0.2 million to $4.4 million. The increase was primarily due to an increase in interest expense as we entered into a term loan facility during the third quarter of 2014.

 

In the fourth quarter of 2014, our net loss increased by $2.1 million to $6.5 million, or loss of $0.39 per common share. The increase was primarily due to an increase in cost of goods sold related to supply chain restructuring and inventory reserves, as well as an increase in SG&A expense due to the timing of the SPECTRUM study costs.

 

In the first quarter of 2015, our net loss decreased by $2.6 million to $3.9 million, or loss of $0.23 per common share. The decrease was primarily due to the higher cost of goods sold in the prior quarter related to supply chain restructuring and inventory reserves, as well as the reversal of certain one-off expenditures in the current quarter that were accrued in prior quarters.

 

LIQUIDITY AND CAPITAL RESOURCES

 

We have financed our operations through cash flow generated from sales of AGGRASTAT® and BRINAVESSTM, the issuance of common shares, and a term loan facility.

 

Cash Flows

 

Sources and Uses of Cash

 

(in thousands of U.S. dollars)  For the Three Months Ended
March 31
 
   2015   2014 
Cash used in operating activities  $(3,168)  $(9,294)
Cash used in investing activities   (102)   (15)
Cash provided by financing activities   74    11,539 
Effect of foreign exchange rate changes on cash and cash equivalents   (320)   22 
Net increase (decrease) in cash and cash equivalents  $(3,516)  $2,252 

 

At March 31, 2015, we had $9.2 million in cash and cash equivalents, compared to $12.7 million at December 31, 2014. The decrease in cash and cash equivalents for the three months ended March 31, 2015 was primarily due to $3.2 million of net cash used in operating activities.

 

Cash used in operating activities for the three months ended March 31, 2015 was $3.2 million, a decrease of $6.1 million from $9.3 million used for the same period in 2014. The decrease in cash used was primarily due to the timing of customer receipts and deferred revenue recognized from an upfront payment from a distributor received during the three months ended March 31, 2015.

 

9
 

 

Cash used in investing activities for the three months ended March 31, 2015 and 2014 was $0.1 million and $0.02 million, respectively.

 

Cash provided by financing activities for the three months ended March 31, 2015 was $0.1 million, compared to $11.5 million for the same period in 2014. During the three months ended March 31, 2014, we received net proceeds of $12.4 million from our common share offering. No such offering took place during the three months ended March 31, 2015.

 

Funding Requirements

 

We expect to devote financial resources to our operations, research and development efforts, clinical trials, nonclinical and preclinical studies and regulatory approvals associated with our products in development, as well as to business development efforts. We will require cash to pay interest and make principal payments on the term loan facility as well as the deferred consideration arising from the acquisition of Correvio.

 

Our future funding requirements will depend on many factors including:

 

·the extent to which we will be successful in obtaining reimbursement for BRINAVESSTM in additional countries where it is currently approved
·the cost and outcomes of regulatory submissions and reviews for approval of BRINAVESSTM in additional countries
·the extent to which BRINAVESSTM will be commercially successful globally
·the extent to which AGGRASTAT® sales will remain stable as it faces generic competition in certain markets
·the future development plans for our products in development
·the consummation of suitable business development opportunities
·the size, cost and effectiveness of our sales and marketing programs
·the consummation, continuation or termination of third-party manufacturing, distribution and sales and marketing arrangements

 

At March 31, 2015, we had working capital of $11.1 million, compared to $14.2 million at December 31, 2014. We believe that our cash on hand, the expected future cash inflows from the sale of BRINAVESSTM and AGGRASTAT®, and expected proceeds from other financial vehicles will be sufficient to finance our working capital, operational, and capital needs for at least the next 12 months, including our obligations with respect to the term loan facility and deferred consideration. If our existing cash resources together with the cash we generate from the sales of our products are insufficient to fund our working capital, operational, and capital needs, we may need to sell additional equity or debt securities or seek additional financing through other arrangements. Any sale of additional equity or debt securities may result in dilution to our shareholders. Debt financing may involve covenants limiting or restricting our ability to take specific actions, such as incurring additional debt or making capital expenditures. Moreover, our ability to obtain additional debt financing may be limited by the term loan facility currently in place. If we seek to raise funds through collaboration or licensing arrangements with third parties, we may be required to relinquish rights to products, product candidates or technologies that we would not otherwise relinquish or grant licenses on terms that may not be favorable to us. There can be no assurance that we will be able to successfully obtain financing in the amounts or terms acceptable to us, if at all, in order to continue our operational activities. If we are unable to obtain financing to fund our development programs and strategic business development activities, we may be required to delay, reduce the scope of, or eliminate one or more of our planned development and commercialization activities, which could harm our future financial condition and operating results.

 

10
 

 

Contractual Obligations

 

As of March 31, 2015, and in the normal course of business, we have the following obligations to make future payments, representing contracts and other commitments that are known and committed.

 

Contractual Obligations  Payment due by period 
(In thousands of U.S. dollars)  2015   2016   2017   2018   2019   There-
after
   Total 
Commitments for clinical and other agreements  $2,996   $471    -    -    -    -   $3,467 
Supplier purchase commitment   1,180    1,180    -    -    -    -    2,360 
Deferred consideration   2,555    3,189    1,355    -    -    -    7,099 
Interest expense on deferred consideration   625    454    135    -    -    -    1,214 
Term loan facility   1,714    4,114    4,114    2,058    -    -    12,000 
Interest expense on term loan facility   741    714    364    51    -    -    1,870 
Operating lease obligations   324    369    282    282    247    988    2,492 
Total  $10,135   $10,491   $6,250   $2,391   $247   $988   $30,502 

 

Outstanding Share Capital

 

As of May 12, 2015, there were 17,205,659 common shares issued and outstanding, and 1,430,340 common shares issuable upon the exercise of outstanding stock options (of which 745,937 were exercisable) at a weighted average exercise price of CAD $5.68 per share, and 138,698 restricted share units outstanding.

 

CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT ESTIMATES

 

We prepare our consolidated financial statements in accordance with U.S. GAAP and we make certain estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, and expenses. On an ongoing basis, we evaluate our estimates and judgments, including those related to revenue recognition, impairment of long-lived assets, goodwill, amortization, stock-based compensation, and fair value measurements of financial instruments. We base our estimates on historical experience, anticipated results and trends and on various other assumptions that we believe are reasonable under the circumstances. By their nature, estimates are subject to an inherent degree of uncertainty. Actual results could differ from our estimates. The discussion on the accounting policies and estimates that require management's most difficult, subjective and complex judgments, and which are subject to a degree of measurement uncertainty, can be found on pages 15 to 17 of our 2014 MD&A, a copy of which is available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov. There were no significant changes in our critical accounting policies in the first quarter of 2015.

 

11
 

 

Recent Accounting Pronouncements

 

Simplifying the Presentation of Debt Issuance Costs

 

In April 2015, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2015-03, Simplifying the Presentation of Debt Issuance Costs, as part of its simplification initiative. ASU 2015-03 changes the presentation of debt issuance costs in financial statements such that an entity presents such costs in the balance sheet as a direct deduction from the related debt liability rather than as an asset. Amortization of the costs is reported as interest expense. ASU 2015-03 is effective for fiscal years beginning after December 15, 2015, and interim periods within those fiscal years. We are currently evaluating the new guidance to determine the impact it will have on our consolidated financial statements.

 

Revenue from Contracts with Customers

 

In April 2015, the FASB voted to propose a deferral of the effective date of the new revenue standard, ASU 2014-09, Revenue from Contracts with Customers, by one year. The new guidance would be effective for fiscal years beginning after December 15, 2017 instead of December 15, 2016. Entities are permitted to adopt in accordance with the original effective date if they choose. We are currently evaluating the new guidance to determine the impact it will have on our consolidated financial statements.

 

Consolidation – Amendments to the Consolidation Analysis

 

In February 2015, the FASB issued ASU 2015-02, Consolidation – Amendments to the Consolidation Analysis.  ASU 2015-02 changes the evaluation of whether limited partnerships, and similar legal entities, are variable interest entities, or VIEs, and eliminates the presumption that a general partner should consolidate a limited partnership that is a voting interest entity. The new guidance also alters the analysis for determining when fees paid to a decision maker or service provider represent a variable interest in a VIE and how interests of related parties affect the primary beneficiary determination.  ASU 2015-02 is effective for fiscal years and interim periods within those fiscal years, beginning after December 15, 2015. The new standard allows early adoption, including early adoption in an interim period. We are currently evaluating the new guidance to determine the impact it will have on our consolidated financial statements.

 

OFF-BALANCE SHEET ARRANGEMENTS

 

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

 

RELATED PARTY TRANSACTIONS

 

We did not enter into any material transactions with related parties during the three months ended March 31, 2015 and 2014.

 

12
 

 

INTERNAL CONTROL OVER FINANCIAL REPORTING

 

We did not make any changes in our internal control over financial reporting during the three months ended March 31, 2015 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. The design of any system of controls and procedures is based in part upon certain assumptions about the likelihood of certain events occurring. There can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions, regardless of how remote.

 

FINANCIAL INSTRUMENTS AND RISKS

 

We are exposed to credit risks and market risks related to changes in interest rates and foreign currency exchange rates, each of which could affect the value of our current assets and liabilities. We invest our cash reserves in fixed rate, highly liquid and highly rated financial instruments such as treasury bills, commercial papers and banker’s acceptances. At March 31, 2015, our cash and cash equivalents were primarily held as cash, the majority of which was denominated in U.S. dollars. We do not believe that the results of operations or cash flows would be affected to any significant degree by a sudden change in market interest rates relative to our investment portfolio, due to the relative short-term nature of the investments and our current ability to hold fixed income investments to maturity. We have not entered into any forward currency contracts or other financial derivatives to hedge foreign exchange risk. We are subject to foreign exchange rate fluctuations that could have a material effect on our future operating results or cash flows. We are exposed to interest rate cash flow risk on our cash and cash equivalents and our long-term debt as these instruments bear interest based on current market rates.

 

13

EX-99.2 3 v410524_ex99-2.htm EXHIBIT 99.2

Exhibit 99.2

 

CARDIOME PHARMA CORP.

 

Interim Consolidated Financial Statements

 

Three months ended March 31, 2015 and 2014

 

(Unaudited)

 

 
 

CARDIOME PHARMA CORP.

Interim Consolidated Balance Sheets

(Unaudited)

(Expressed in thousands of U.S. dollars, except share amounts)

 

 

 

   March 31,
2015
   December 31,
2014
 
         
Assets          
           
Current assets:          
Cash and cash equivalents  $9,192   $12,708 
Restricted cash (note 4)   2,170    2,320 
Accounts receivable, net of allowance for doubtful accounts of $421 (2014 - $596)   6,640    9,504 
Inventories (note 5)   4,585    5,335 
Prepaid expenses and other assets   2,062    1,703 
Deferred tax asset   439    439 
    25,088    32,009 
Property and equipment (note 6)   853    811 
Intangible assets (note 7)   15,675    16,156 
Goodwill   318    318 
Other assets   718    821 
   $42,652   $50,115 
           
Liabilities and Stockholders’ Equity          
           
Current liabilities:          
Accounts payable and accrued liabilities (note 8)  $8,223   $13,057 
Current portion of long-term debt (note 9)   2,743    1,714 
Current portion of deferred consideration   2,999    3,044 
    13,965    17,815 
           
Long-term debt (note 9)   9,257    10,286 
Deferred consideration   4,100    4,544 
Deferred revenue   975    - 
Other long-term liabilities   297    331 
    28,594    32,976 
           
Stockholders’ equity:          
Common stock   286,078    284,760 
Authorized - unlimited number with no par value          
Issued and outstanding – 16,773,164 (2014 – 16,591,002) (note 10)          
Additional paid-in capital   33,797    34,229 
Deficit   (322,860)   (318,973)
Accumulated other comprehensive income   17,043    17,123 
    14,058    17,139 
   $42,652   $50,115 

 

Contingencies (note 13)

 

See accompanying notes to the consolidated financial statements.

 

 
 

  

CARDIOME PHARMA CORP.

Interim Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

(Expressed in thousands of U.S. dollars, except share and per share amounts)

 

 

 

   Three months ended 
   March 31,
2015
   March 31,
2014
 
Revenue:          
Product and royalty revenues  $5,472   $7,592 
Licensing and other fees   25    - 
    5,497    7,592 
Cost of goods sold   1,224    1,493 
Gross margin   4,273    6,099 
Expenses:          
Selling, general and administration   6,327    7,999 
Research and development   62    245 
Amortization (notes 6 and 7)   541    536 
    6,930    8,780 
Operating loss   (2,657)   (2,681)
           
Other expense:          
Interest expense   674    254 
Other expense (income)   69    (99)
Foreign exchange loss   380    181 
    1,123    336 
Loss before income taxes   (3,780)   (3,017)
Provision for income taxes   107    117 
Net loss  $(3,887)  $(3,134)
Other comprehensive income (loss):          
Foreign currency translation adjustments   (80)   162 
Comprehensive loss  $(3,967)  $(2,972)
           
Loss per common share – basic and diluted (note 12)  $(0.23)  $(0.20)
           
Weighted average number of common shares
Outstanding – basic and diluted (note 12)
   16,670,341    15,337,166 

 

See accompanying notes to the consolidated financial statements.

 

 
 

CARDIOME PHARMA CORP.

Interim Consolidated Statements of Stockholders’ Equity

(Unaudited)

(Expressed in thousands of U.S. dollars)

 

 

 

   Number of
common
shares
   Common
shares
   Additional
paid-in capital
   Deficit   Accumulated
other
comprehensive
income
   Total
stockholders’
equity
 
Balance at December 31, 2013   14,958,277   $272,083   $33,349   $(300,746)  $17,958   $22,644 
Net loss   -    -    -    (18,227)   -    (18,227)
Issuance of common stock   1,530,513    13,821    -    -    -    13,821 
Share issue costs   -    (1,415)   -    -    -    (1,415)
Common stock issued upon exercise of options   102,212    148    -    -    -    148 
Reallocation of additional paid in capital arising from stock-based compensation related to exercise of options   -    123    (123)   -    -    - 
Stock-based compensation expense   -    -    1,003    -    -    1,003 
Foreign currency translation adjustments   -    -    -    -    (835)   (835)
Balance at December 31, 2014   16,591,002   $284,760   $34,229   $(318,973)  $17,123   $17,139 
Net loss   -    -    -    (3,887)   -    (3,887)
Issuance of common stock (note 10)   88,467    895    -    -    -    895 
Share issue costs (note 10)   -    (38)   -    -    -    (38)
Common stock issued upon exercise of options   93,695    264    -    -    -    264 
Reallocation of additional paid in capital arising from stock-based compensation related to exercise of options   -    197    (197)   -    -    - 
Stock-based compensation expense (note 11)   -    -    (235)   -    -    (235)
Foreign currency translation adjustments   -    -    -    -    (80)   (80)
Balance at March 31, 2015   16,773,164   $286,078   $33,797   $(322,860)  $17,043   $14,058 

 

See accompanying notes to the consolidated financial statements.

 

 
 

CARDIOME PHARMA CORP.

Interim Consolidated Statements of Cash Flows

(Unaudited)

(Expressed in thousands of U.S. dollars)

 

 

 

   Three months ended 
   March 31, 2015   March 31, 2014 
Operating activities:          
Net loss  $(3,887)  $(3,134)
Items not affecting cash:          
Amortization   541    536 
Amortization of deferred financing fees   129    - 
Write-down of inventory (note 5)   95    - 
Stock-based compensation (note 11)   465    226 
Unrealized foreign exchange gain   380    56 
Changes in operating assets and liabilities:          
Restricted cash   -    (25)
Accounts receivable   2,237    (508)
Inventories   655    (839)
Prepaid expenses and other assets   (385)   (1,154)
Accounts payable and accrued liabilities   (4,339)   (4,452)
Deferred revenue   975    - 
Other long-term liabilities   (34)   - 
Net cash used in operating activities   (3,168)   (9,294)
           
Investing activities:          
Purchase of property and equipment   (89)   (3)
Increase in intangible assets   (13)   (12)
Net cash used in investing activities   (102)   (15)
           
Financing activities:          
Issuance of common stock (note 10)   895    13,821 
Share issue costs (note 10)   (38)   (1,411)
Issuance of common stock upon exercise of stock options   264    - 
Payment of deferred consideration   (1,047)   (871)
Net cash provided by financing activities   74    11,539 
           
Effect of foreign exchange rate changes on cash and cash equivalents   (320)   22 
Increase (decrease) in cash and cash equivalents during the period   (3,516)   2,252 
Cash and cash equivalents, beginning of period   12,708    10,984 
Cash and cash equivalents, end of period  $9,192   $13,236 
           
Supplemental cash flow information:          
Interest paid  $1,639   $296 
Net income taxes paid   259    45 

 

See accompanying notes to the consolidated financial statements.

 

 
 

CARDIOME PHARMA CORP.

Notes to Interim Consolidated Financial Statements

(Unaudited)

(Expressed in thousands of U.S. dollars except share and per share amounts and where otherwise indicated)

 

As at and for the three months ended March 31, 2015 and 2014

 

 

1.Basis of presentation:

 

These unaudited interim consolidated financial statements have been prepared by management in accordance with generally accepted accounting principles used in the United States of America (“U.S. GAAP”) and are presented in U.S. dollars. They include all adjustments consisting solely of normal, recurring adjustments which, in the opinion of management, are necessary for fair presentation of the periods presented. These unaudited interim consolidated financial statements do not include all the disclosures required under U.S. GAAP for annual financial statements and should be read in conjunction with the annual audited consolidated financial statements for the year ended December 31, 2014 filed with the appropriate securities commissions. The results of operations for the three months ended March 31, 2015 and 2014 are not necessarily indicative of the results for the full year.

 

Cardiome Pharma Corp. (the “Company”) has financed its cash requirements primarily from sales of BRINAVESSTM and AGGRASTAT®, share issuances, a term loan facility, and cash from a previous collaborative partner. The Company’s ability to attain profitability and positive cash flows from operations is dependent on a number of factors, including the extent to which BRINAVESSTM will be commercially successful globally, the extent to which AGGRASTAT® sales will remain stable as it faces generic competition in certain markets, and business development activities, the outcome of which cannot be predicted at this time. As a result, it may be necessary for the Company to obtain additional funds in the future. These funds may come from sources such as the issuance of equity and/or debt securities, or alternative sources of financing. There can be no assurance that the Company will be able to successfully obtain sufficient funds to continue the development and commercialization of its products and its operational activities.

 

2.Significant accounting policies:

 

Recent accounting pronouncements:

 

In April 2015, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2015-03, Simplifying the Presentation of Debt Issuance Costs, as part of its simplification initiative. ASU 2015-03 changes the presentation of debt issuance costs in financial statements such that an entity presents such costs in the balance sheet as a direct deduction from the related debt liability rather than as an asset. Amortization of the costs is reported as interest expense. ASU 2015-03 is effective for fiscal years beginning after December 15, 2015, and interim periods within those fiscal years. The Company is currently evaluating the new guidance to determine the impact it will have on its consolidated financial statements.

 

In April 2015, the FASB voted to propose a deferral of the effective date of the new revenue standard, ASU 2014-09, Revenue from Contracts with Customers, by one year. The new guidance would be effective for fiscal years beginning after December 15, 2017 instead of December 15, 2016. Entities are permitted to adopt in accordance with the original effective date if they choose. The Company is currently evaluating the new guidance to determine the impact it will have on its consolidated financial statements.

 

2
 

 

CARDIOME PHARMA CORP.

Notes to Interim Consolidated Financial Statements

(Unaudited)

(Expressed in thousands of U.S. dollars except share and per share amounts and where otherwise indicated)

 

As at and for the three months ended March 31, 2015 and 2014

 

 

2.Significant accounting policies (continued):

 

Recent accounting pronouncements (continued):

 

In February 2015, the FASB issued ASU 2015-02, Consolidation – Amendments to the Consolidation Analysis.  ASU 2015-02 changes the evaluation of whether limited partnerships, and similar legal entities, are variable interest entities, or VIEs, and eliminates the presumption that a general partner should consolidate a limited partnership that is a voting interest entity. The new guidance also alters the analysis for determining when fees paid to a decision maker or service provider represent a variable interest in a VIE and how interests of related parties affect the primary beneficiary determination.  ASU 2015-02 is effective for fiscal years and interim periods within those fiscal years, beginning after December 15, 2015. The new standard allows early adoption, including early adoption in an interim period. The Company is currently evaluating the new guidance to determine the impact it will have on its consolidated financial statements.

 

3.Financial instruments:

 

Financial instruments consist of cash and cash equivalents, restricted cash, accounts receivable, accounts payable and accrued liabilities, long-term debt, and deferred consideration. The fair values of cash and cash equivalents, restricted cash, accounts receivable and accounts payable and accrued liabilities approximate their carrying values because of their short-term nature. At March 31, 2015, the carrying value of the Company’s long-term debt and deferred consideration approximate their fair value based on current market borrowing rates. Long-term debt is classified as Level 2 of the fair value hierarchy. Deferred consideration is classified as Level 3 of the fair value hierarchy.

 

4.Restricted cash:

 

At March 31, 2015, restricted cash included $1,000 (December 31, 2014 - $1,000) relating to amounts held in escrow in a non-interest bearing account in connection with the acquisition of Correvio LLC. This amount will be released from escrow upon the Company’s payment of all amounts owing under the deferred consideration liability plus all applicable accrued interest.

 

The Company also held restricted cash relating to deposits which are pledged as collateral for bank guarantees for sales contracts with various hospitals and health authorities of $1,170 (December 31, 2014 - $1,320).

 

3
 

 

CARDIOME PHARMA CORP.

Notes to Interim Consolidated Financial Statements

(Unaudited)

(Expressed in thousands of U.S. dollars except share and per share amounts and where otherwise indicated)

 

As at and for the three months ended March 31, 2015 and 2014

 

 

5.Inventories:

 

   March 31,   December 31, 
   2015   2014 
         
Finished goods  $1,398   $1,815 
Work in process   740    1,013 
Raw materials   2,405    2,449 
Inventory consigned to others   42    58 
   $4,585   $5,335 

 

During the three months ended March 31, 2015, the Company had a write-down of inventory of $95 (three months ended March 31, 2014 - nil) which is included in cost of goods sold.

 

6.Property and equipment:

 

       Accumulated   Net book 
March 31, 2015  Cost   amortization   value 
             
Laboratory equipment  $625   $556   $69 
Production equipment   97    20    77 
Software   165    50    115 
Computer equipment   221    118    103 
Leasehold improvements   399    42    357 
Furniture and office equipment   151    19    132 
                
   $1,658   $805   $853 

 

       Accumulated   Net book 
December 31, 2014  Cost   amortization   value 
             
Laboratory equipment  $625   $542   $83 
Production equipment   96    16    80 
Software   110    46    64 
Computer equipment   200    111    89 
Leasehold improvements   416    30    386 
Furniture and office equipment   122    13    109 
                
   $1,569   $758   $811 

 

Amortization expense for the three months ended March 31, 2015 amounted to $47 (three months ended March 31, 2014 - $35).

 

4
 

 

CARDIOME PHARMA CORP.

Notes to Interim Consolidated Financial Statements

(Unaudited)

(Expressed in thousands of U.S. dollars except share and per share amounts and where otherwise indicated)

 

As at and for the three months ended March 31, 2015 and 2014

 

 

7.Intangible assets:

 

       Accumulated   Net book 
March 31, 2015  Cost   amortization   value 
             
Marketing rights  $15,830   $2,178   $13,652 
Trade name   1,131    155    976 
Patents   4,286    3,239    1,047 
                
   $21,247   $5,572   $15,675 

 

       Accumulated   Net book 
December 31, 2014  Cost   amortization   value 
             
Marketing rights  $15,830   $1,782   $14,048 
Trade name    1,131    127    1,004 
Patents   4,273    3,169    1,104 
                
   $21,234   $5,078   $16,156 

 

Amortization expense for the three months ended March 31, 2015 amounted to $494 (three months ended March 31, 2014 - $501).

 

8.Accounts payable and accrued liabilities:

 

   March 31,   December 31, 
   2015   2014 
         
Trade accounts payable  $1,748   $5,474 
Employee-related accruals   2,050    2,719 
Interest payable    71    291 
Other accrued liabilities   4,354    4,573 
           
   $8,223   $13,057 

 

5
 

 

CARDIOME PHARMA CORP.

Notes to Interim Consolidated Financial Statements

(Unaudited)

(Expressed in thousands of U.S. dollars except share and per share amounts and where otherwise indicated)

 

As at and for the three months ended March 31, 2015 and 2014

 

 

9.Long-term debt:

 

   March 31,   December 31, 
   2015   2014 
         
Long-term debt  $12,000   $12,000 
Less: Current portion   (2,743)   (1,714)
           
   $9,257   $10,286 

 

10.Share capital:

 

On February 18, 2014, the Company completed a prospectus supplement under which the Company may issue common shares in one or more at-the-market (“ATM”) offerings up to an aggregate of $8,900. During the three months ended March 31, 2015, the Company issued 88,467 common shares under the ATM program for gross proceeds of $895.

 

11.Share-based compensation:

 

(a)Stock options:

 

Details of stock option transactions for the three months ended March 31, 2015 are summarized as follows:

 

   Number   Weighted
average
exercise
price
(CAD$)
   Weighted
average
remaining
contractual
life (years)
   Aggregate
intrinsic
value
(CAD$)
 
Outstanding as at December 31, 2014   1,278,290    4.68    3.34    8,411 
                     
Options granted   260,800    10.35           
Options exercised   (96,515)   3.83           
Options forfeited   (8,235)   19.67           
Outstanding as at March 31, 2015   1,434,340    5.68    3.45    9,334 
Exercisable as at March 31, 2015   720,633    4.34    2.77    5,956 

 

The outstanding options expire at various dates ranging from May 25, 2015 to March 26, 2020.

 

6
 

 

CARDIOME PHARMA CORP.

Notes to Interim Consolidated Financial Statements

(Unaudited)

(Expressed in thousands of U.S. dollars except share and per share amounts and where otherwise indicated)

 

As at and for the three months ended March 31, 2015 and 2014

 

 

11.Share-based compensation (continued):

 

(a)Stock options (continued):

 

At March 31, 2015, stock options to executive officers and directors, employees and consultants were outstanding as follows:

 

   Options outstanding   Options exercisable 
       Weighted   Weighted       Weighted 
       average   average       average 
       remaining   exercise       exercise 
Range of      contractual   price       price 
exercise prices (CAD$)  Number   life (years)   (CAD$)   Number   (CAD$) 
                     
$1.65 to $2.08   463,000    2.74    1.67    317,041    1.68 
$2.09 to $3.78   200,000    2.26    2.45    194,196    2.45 
$3.79 to $5.10   247,760    3.64    5.10    116,178    5.10 
$5.11 to $43.20   523,580    4.43    10.73    93,218    16.41 
                          
    1,434,340    3.45    5.68    720,633    4.34 

 

As of March 31, 2015, there was $1,843 (December 31, 2014 - $1,023) of total unrecognized compensation cost related to non-vested stock options. That cost is expected to be recognized over a weighted average period of 1.5 years (December 31, 2014 – 1.6 years).

 

The aggregate fair value of vested options during the three months ended March 31, 2015 was $377 (three months ended March 31, 2014 - $124).

 

The estimated fair value of options granted to executive officers and directors, and employees is amortized over the vesting period. For the three months ended March 31, 2015, stock-based compensation expense of $465 (three months ended March 31, 2014 - $226) is recorded in selling, general and administration expenses.

 

The weighted average fair value of stock options granted during the three months ended March 31, 2015 was $4.21 (three months ended March 31, 2014 - nil). The estimated fair value of the stock options granted was determined using the Black-Scholes option pricing model with the following weighted-average assumptions:

 

Three months ended March 31  2015   2014 
         
Dividend yield   -    - 
Expected volatility   76.5%   - 
Risk-free interest rate   0.6%     -  
Expected average life of the options   3.0 years    - 
Estimated forfeiture rate   -    - 

 

7
 

 

CARDIOME PHARMA CORP.

Notes to Interim Consolidated Financial Statements

(Unaudited)

(Expressed in thousands of U.S. dollars except share and per share amounts and where otherwise indicated)

 

As at and for the three months ended March 31, 2015 and 2014

 

 

11.Share-based compensation (continued):

 

(b)Restricted share unit plan:

 

During the three months ended March 31, 2015, the Company approved 81,698 restricted share units (“RSUs”) which are not considered granted under U.S. GAAP criteria. At March 31, 2015, there are 139,198 RSUs that have been approved but not considered granted.

 

12.Loss per share:

 

Loss per share is calculated as set forth below:

 

Three months ended March 31  2015   2014 
         
Net loss  $(3,887)  $(3,134)
Weighted average number of common shares for loss per share – basic and diluted   16,670,341    15,337,166 
           
Loss per share – basic and diluted  $(0.23)  $(0.20)

 

As the Company incurred a loss, all unexercised share-based payment awards were anti-dilutive and are excluded from the diluted weighted average shares.

 

13.Contingencies:

 

(a)The Company may, from time to time, be subject to claims and legal proceedings brought against it in the normal course of business. Such matters are subject to many uncertainties. Management believes that adequate provisions have been made in the accounts where required and the ultimate resolution of such contingencies will not have a material adverse effect on the consolidated financial position of the Company.

 

(b)The Company entered into indemnification agreements with all officers and directors. The maximum potential amount of future payments required under these indemnification agreements is unlimited. However, the Company maintains appropriate liability insurance that limits the exposure and enables the Company to recover any future amounts paid, less any deductible amounts pursuant to the terms of the respective policies, the amounts of which are not considered material.

 

(c)The Company has entered into various agreements with third parties that include indemnification provisions. These indemnification provisions generally require the Company to compensate the other party for certain damages and costs incurred as a result of third party claims or damages arising from these transactions. In some cases, the maximum potential amount of future payments that could be required under these indemnification provisions is unlimited. These indemnification provisions may survive termination of the underlying agreement. The nature of the indemnification obligations prevents the Company from making a reasonable estimate of the maximum potential amount it could be required to pay. Historically, the Company has not made any indemnification payments under such agreements and no amount has been accrued in the accompanying consolidated financial statements with respect to these indemnification obligations.

 

8
 

 

CARDIOME PHARMA CORP.

Notes to Interim Consolidated Financial Statements

(Unaudited)

(Expressed in thousands of U.S. dollars except share and per share amounts and where otherwise indicated)

 

As at and for the three months ended March 31, 2015 and 2014

 

 

14.Comparative figures:

 

Certain comparative figures presented in the interim consolidated financial statements have been reclassified to conform to the current period presentation.

 

15.Segmented information:

 

During 2013, the Company began recognizing revenue from product sales at which time management began to measure the Company’s operations by the geographic area in which such products are sold.

 

 

Three months ended March 31, 2015  Europe   Rest of World   Total 
             
Revenue   2,791    2,706    5,497 
Cost of goods sold   735    489    1,224 
Gross margin   2,056    2,217    4,273 

 

Three months ended March 31, 2014  Europe   Rest of World   Total 
             
Revenue  $4,024   $3,568   $7,592 
Cost of goods sold   748    745    1,493 
Gross margin   3,276    2,823    6,099 

 

During the three months ended March 31, 2015 and 2014, we had two customers that individually accounted for more than 10% of our revenue. In 2015, these two customers accounted for 28% and 22% of our revenue (2014 – 21% and 14%).

 

9
 

 

CARDIOME PHARMA CORP.

Notes to Interim Consolidated Financial Statements

(Unaudited)

(Expressed in thousands of U.S. dollars except share and per share amounts and where otherwise indicated)

 

As at and for the three months ended March 31, 2015 and 2014

 

 

15.Segmented information (continued):

 

Property and equipment by geographic area were as follows:

 

  March 31, 2015   December 31, 2014 
         
Europe   120    118 
Rest of world   733    693 
           
    853    811 

 

10

EX-99.3 4 v410524_ex99-3.htm EXHIBIT 99.3

Exhibit 99.3

 

Form 51-102F3

MATERIAL CHANGE REPORT

 

Item 1. Name and Address of Reporting Issuer

 

  Cardiome Pharma Corp. (“Cardiome” or the “Corporation”)
  1441 Creekside Drive, 6th floor
  Vancouver, BC V6J 4S7

 

Item 2. Date of Material Change

 

  May 13, 2015

 

Item 3. News Release

 

  May 13, 2015 – Vancouver, Canada.

 

Item 4. Summary of Material Change

 

  Cardiome reported financial results for its first quarter ended March 31, 2015. Amounts, unless specified otherwise, are expressed in U.S. dollars and in accordance with generally accepted accounting principles used in the United States of America (U.S. GAAP).

 

Item 5. 5.1 - Full Description of Material Change

 

  See attached press release.
 
  5.2 – Disclosure for Restructuring Transactions
   
  Not applicable.

 

Item 6. Reliance on subsection 7.1(2) of National Instrument 51-102

 

  Not applicable.

 

Item 7. Omitted Information

 

  Not applicable.

 

Item 8. Executive Officer

 

  Jennifer Archibald, Chief Financial Officer
  Telephone: 604-677-6905.

 

Item 9. Date of Report

 

  This Material Change Report is dated May 13, 2015.

 

 
 

 

 

 

1441 Creekside Drive, 6th Floor

Vancouver, B.C.

V6J 4S7

Tel: 604-677-6905

Fax: 604-677-6915

 

  

FOR IMMEDIATE RELEASE NASDAQ: CRME TSX: COM

 

Cardiome Reports First Quarter 2015 FINANCIAL Results

 

Cardiome to conduct conference call and webcast today,

May 13, 2015 at 8:00 a.m. Eastern (5:00 a.m. Pacific)

 

Vancouver, Canada, May 13, 2015 -- Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today reported financial results for the first quarter ended March 31, 2015. Amounts, unless specified otherwise, are expressed in U.S. dollars and in accordance with generally accepted accounting principles used in the United States of America (U.S. GAAP).

 

Summary Results

Cardiome recorded a net loss of $3.9 million (loss per share of $0.23) for the three months ended March 31, 2015 (Q1-2015), compared to a net loss of $3.1 million (loss per share of $0.20) for the three months ended March 31, 2014 (Q1-2014).

 

Revenue for Q1-2015 was $5.5 million, compared to revenue of $7.6 million for Q1-2014. The decrease was due primarily to foreign exchange, timing of distributor sales, and a decrease in AGGRASTAT® sales due to generic competition.

 

Generic erosion of AGGRASTAT® sales had an impact on revenues this quarter as generics have entered Germany, France and UK in line with Cardiome’s expectations. The impact has primarily been related to price and not to volume. Q1-2015 sales were also impacted by Cardiome’s decision to exit the AGGRASTAT® market in Turkey in late 2014 due to unfavorable margins in that country. Despite this, AGGRASTAT® revenues continue to exceed expectations and are forecasted to be $24-25M in 2015.

 

Although growth in BRINAVESS sales has been strong and is expected to continue, given its smaller revenue base, BRINAVESS sales will not completely offset the decline in AGGRASTAT® sales in the near term. Cardiome expects this trend to reverse in the future as BRINAVESS sales grow off of an increasing revenue base and as the Company adds additional revenue-contributing products.

 

Cardiome announced yesterday that it has signed an exclusive distribution agreement with AOP Orphan to market and sell ESMOCARD® in Italy, France, Spain and Belgium. ESMOCARD®, an i.v. beta-blocker used for tachycardia and hypertension, is a complimentary product to BRINAVESS and AGGRASTAT® that is used in the emergency room, post-surgically and in interventional cardiology; Cardiome’s primary in-hospital call points. It is estimated that with limited or no promotion, Baxter currently sells $13M of Esmolol in the markets we will be covering. The ESMOCARD® transaction will be immediately accretive in 2015 and is expected to begin contributing revenue as early as Q3 of this year.

 

Cost of goods sold for Q1-2015 was $1.2 million, compared to cost of goods sold of $1.5 million for Q1-2014.

 

 
 

 

Selling, general and administration (SG&A) expense for Q1-2015 was $6.3 million, compared to SG&A expense of $8.0 million for Q1-2014. The decrease was due primarily to the reversal of certain one-off expenditures accrued in prior quarters, one-time costs incurred in the prior year related to the acquisition of Correvio, and foreign exchange.

 

Other expense increased to $1.1 million for Q1-2015 from $0.3 million for Q1-2014. This is primarily due to interest expense incurred on the senior secured term loan facility. Cardiome entered into this term loan facility in July 2014.

 

Liquidity and Outstanding Share Capital

At March 31, 2015, the Company had cash and cash equivalents of $9.2 million. As of May 12, 2015, the Company had 17,205,659 common shares issued and outstanding and 1,430,340 common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of CAD $5.68 per share, and 138,698 restricted share units outstanding.

 

 

 
 

 

Conference Call

Cardiome will hold a teleconference and webcast on Tuesday, May 13, 2015 at 8:00 am Eastern (5:00 am Pacific). To access the conference call, please dial 416-764-8688 or 888-390-0546 and use conference ID 00212153. The webcast can be accessed through Cardiome’s website at www.cardiome.com.

 

Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call through June 9, 2015. Please dial 416-764-8677 or 888-390-0541 and enter code 212153# to access the replay.

 

About Cardiome Pharma Corp.

Cardiome Pharma Corp. is a specialty pharmaceutical company dedicated to the development and commercialization of cardiovascular therapies that will improve the quality of life and health of patients suffering from heart disease. Cardiome has two marketed, in-hospital, cardiology products, BRINAVESS (vernakalant (IV)), approved in Europe and other territories for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults, and AGGRASTAT® (tirofiban HCl) a reversible GP IIb/IIIa inhibitor indicated for use in patients with acute coronary syndrome.

 

Cardiome is traded on the NASDAQ Capital Market (CRME) and the Toronto Stock Exchange (COM). For more information, please visit our web site at www.cardiome.com.

 

Forward-Looking Statement Disclaimer

Certain statements in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation that may not be based on historical fact, including without limitation statements containing the words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” and similar expressions. Forward- looking statements may involve, but are not limited to, comments with respect to our objectives and priorities for 2015 and beyond, our strategies or future actions, our targets, expectations for our financial condition and the results of, or outlook for, our operations, research and development and product and drug development. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Many such known risks, uncertainties and other factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, the following: general economic and business conditions in the United States, Canada, Europe, and the other regions in which we operate; market demand; technological changes that could impact our existing products or our ability to develop and commercialize future products; competition; existing governmental legislation and regulations and changes in, or the failure to comply with, governmental legislation and regulations; availability of financial reimbursement coverage from governmental and third-party payers for products and related treatments; adverse results or unexpected delays in pre-clinical and clinical product development processes; adverse findings related to the safety and/or efficacy of our products or products; decisions, and the timing of decisions, made by health regulatory agencies regarding approval of our technology and products; the requirement for substantial funding to expand commercialization activities; and any other factors that may affect our performance. In addition, our business is subject to certain operating risks that may cause any results expressed or implied by the forward-looking statements in this presentation to differ materially from our actual results. These operating risks include: our ability to attract and retain qualified personnel; our ability to successfully complete pre-clinical and clinical development of our products; changes in our business strategy or development plans; intellectual property matters, including the unenforceability or loss of patent protection resulting from third-party challenges to our patents; market acceptance of our technology and products; our ability to successfully manufacture, market and sell our products; the availability of capital to finance our activities; and any other factors described in detail in our filings with the Securities and Exchange Commission available at www.sec.gov and the Canadian securities regulatory authorities at www.sedar.com. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on our current expectations and we undertake no obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.

 

 
 

 

CARDIOME PHARMA CORP.

Interim Consolidated Balance Sheets

(Unaudited)

(Expressed in thousands of U.S. dollars, except share amounts)

 

 

 

   March 31 
2015
   December 31, 2014 
         
Assets          
Current assets:          
Cash and cash equivalents  $9,192   $12,708 
Restricted cash   2,170    2,320 
Accounts receivable, net of allowance for doubtful accounts of $421 (2014 - $596)   6,640    9,504 
Inventories   4,585    5,335 
Prepaid expenses and other assets   2,062    1,703 
Deferred tax asset   439    439 
    25,088    32,009 
           
Property and equipment   853    811 
Intangible assets   15,675    16,156 
Goodwill   318    318 
Other assets   718    821 
   $42,652   $50,115 
           
Liabilities and Stockholders’ Equity          
Current liabilities:          
Accounts payable and accrued liabilities  $8,223   $13,057 
Current portion of long-term debt   2,743    1,714 
Current portion of deferred consideration   2,999    3,044 
    13,965    17,815 
           
Long-term debt   9,257    10,286 
Deferred consideration   4,100    4,544 
Deferred revenue   975    - 
Other long-term liabilities   297    331 
    28,594    32,976 
           
Stockholders’ equity:          
Common stock   286,078    284,760 
Authorized - unlimited number with no par value          
Issued and outstanding – 16,773,164 (2014 – 16,591,002)          
Additional paid-in capital   33,797    34,229 
Deficit   (322,860)   (318,973)
Accumulated other comprehensive income   17,043    17,123 
    14,058    17,139 
   $42,652   $50,115 

 

 
 

 

CARDIOME PHARMA CORP.

Interim Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

(Expressed in thousands of U.S. dollars, except share and per share amounts)

 

 

 

   Three months ended 
   March 31,
2015
   March 31,
2014
 
Revenue:          
Product and royalty revenues  $5,472   $7,592 
Licensing and other fees    25    - 
    5,497    7,592 
Cost of goods sold   1,224    1,493 
    4,273    6,099 
Expenses:          
Selling, general and administration   6,327    7,999 
Research and development   62    245 
Amortization   541    536 
    6,930    8,780 
Operating loss   (2,657)   (2,681)
           
Other expense:          
Interest expense   674    254 
Other expense (income)   69    (99)
Foreign exchange loss   380    181 
    1,123    336 
Loss before income taxes   (3,780)   (3,017)
Provision for income taxes   107    117 
Net loss  $(3,887)  $(3,134)
Other comprehensive income (loss):          
Foreign currency translation adjustments   (80)   162 
Comprehensive loss  $(3,967)  $(2,972)
Loss per common share – basic and diluted
  $(0.23)  $(0.20)
Weighted average number of common shares
Outstanding – basic and diluted
   16,670,341    15,337,166 

 

 
 

 

CARDIOME PHARMA CORP.

Interim Consolidated Statements of Cash Flows

(Unaudited)

(Expressed in thousands of U.S. dollars)

 

 

 

    Three months ended  
    March 31,
2015
    March 31,
2014
 
Operating activities:                
Net loss   $ (3,887 )   $ (3,134 )
Items not affecting cash:                
Amortization     541       536  
Amortization of deferred financing fees     129       -  
Write-down of inventory     95       -  
Stock-based compensation     465       226  
Unrealized foreign exchange gain     380       56  
Changes in operating assets and liabilities:                
Restricted cash     -       (25 )
Accounts receivable     2,237       (508 )
Inventories     655       (839 )
Prepaid expenses and other assets     (385 )     (1,154 )
Accounts payable and accrued liabilities     (4,339 )     (4,452 )
Deferred revenue     975       -  
Other long-term liabilities     (34 )     -  
Net cash used in operating activities     (3,168 )     (9,294 )
                 
Investing activities:                
Purchase of property and equipment     (89 )     (3 )
Increase in intangible assets     (13 )     (12 )
Net cash used in investing activities     (102 )     (15 )
                 
Financing activities:                
Issuance of common stock     895       13,821  
Share issue costs     (38 )     (1,411 )
Issuance of common stock upon exercise of stock options     264       -  
Payment of deferred consideration     (1,047 )     (871 )
Net cash provided by financing activities     74       11,539  
                 
Effect of foreign exchange rate changes on cash and cash equivalents     (320 )     22  
Increase (decrease) in cash and cash equivalents during the period     (3,516 )     2,252  
Cash and cash equivalents, beginning of period     12,708       10,984  
Cash and cash equivalents, end of period   $ 9,192     $ 13,236  

 

 
 

 

For Further Information:
Cardiome Investor Relations
(604) 676-6993 or Toll Free: 1-800-330-9928
Email: ir@cardiome.com

 

###

 

 

EX-99.4 5 v410524_ex99-4.htm EXHIBIT 99.4

Exhibit 99.4

 

Form 52-109F2

Certification of interim filings - full certificate

 

I, William Hunter, President and Chief Executive Officer of Cardiome Pharma Corp., certify the following:

 

1.Review: I have reviewed the interim financial report and interim MD&A (together, the “interim filings”) of Cardiome Pharma Corp. (the “issuer”) for the interim period ended March 31, 2015.

 

2.No misrepresentations: Based on my knowledge, having exercised reasonable diligence, the interim filings do not contain any untrue statement of a material fact or omit to state a material fact required to be stated or that is necessary to make a statement not misleading in light of the circumstances under which it was made, with respect to the period covered by the interim filings.

 

3.Fair presentation: Based on my knowledge, having exercised reasonable diligence, the interim financial report together with the other financial information included in the interim filings fairly present in all material respects the financial condition, financial performance and cash flows of the issuer, as of the date of and for the periods presented in the interim filings.

 

4.Responsibility: The issuer’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (DC&P) and internal control over financial reporting (ICFR), as those terms are defined in National Instrument 52-109 Certification of Disclosure in Issuers’ Annual and Interim Filings, for the issuer.

 

5.Design: Subject to the limitations, if any, described in paragraphs 5.2 and 5.3, the issuer’s other certifying officer(s) and I have, as at the end of the period covered by the interim filings

 

(a)designed DC&P, or caused it to be designed under our supervision, to provide reasonable assurance that

 

(i)material information relating to the issuer is made known to us by others, particularly during the period in which the interim filings are being prepared; and

 

(ii)information required to be disclosed by the issuer in its annual filings, interim filings or other reports filed or submitted by it under securities legislation is recorded, processed, summarized and reported within the time periods specified in securities legislation; and

 

(b)designed ICFR, or caused it to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with the issuer’s GAAP.

 

5.1Control framework: The control framework the issuer’s other certifying officer(s) and I used to design the issuer’s ICFR is the Committee of Sponsoring Organizations of the Treadway Commission (COSO) framework (1992).

 

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

 

5.3Limitation on scope of design: N/A

 

 
 

 

6.Reporting changes in ICFR: The issuer has disclosed in its interim MD&A any change in the issuer’s ICFR that occurred during the period beginning on January 1, 2015 and ended on March 31, 2015 that has materially affected, or is reasonably likely to materially affect, the issuer’s ICFR.

 

Date: May 13, 2015

 

William Hunter  

William Hunter

President and Chief Executive Officer

2

 

 

EX-99.5 6 v410524_ex99-5.htm EXHIBIT 99.5

Exhibit 99.5

 

Form 52-109F2

Certification of interim filings - full certificate

 

I, Jennifer Archibald, Chief Financial Officer of Cardiome Pharma Corp., certify the following:

 

1.Review: I have reviewed the interim financial report and interim MD&A (together, the “interim filings”) of Cardiome Pharma Corp. (the “issuer”) for the interim period ended March 31, 2015.

 

2.No misrepresentations: Based on my knowledge, having exercised reasonable diligence, the interim filings do not contain any untrue statement of a material fact or omit to state a material fact required to be stated or that is necessary to make a statement not misleading in light of the circumstances under which it was made, with respect to the period covered by the interim filings.

 

3.Fair presentation: Based on my knowledge, having exercised reasonable diligence, the interim financial report together with the other financial information included in the interim filings fairly present in all material respects the financial condition, financial performance and cash flows of the issuer, as of the date of and for the periods presented in the interim filings.

 

4.Responsibility: The issuer’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (DC&P) and internal control over financial reporting (ICFR), as those terms are defined in National Instrument 52-109 Certification of Disclosure in Issuers’ Annual and Interim Filings, for the issuer.

 

5.Design: Subject to the limitations, if any, described in paragraphs 5.2 and 5.3, the issuer’s other certifying officer(s) and I have, as at the end of the period covered by the interim filings

 

(a)designed DC&P, or caused it to be designed under our supervision, to provide reasonable assurance that

 

(i)material information relating to the issuer is made known to us by others, particularly during the period in which the interim filings are being prepared; and

 

(ii)information required to be disclosed by the issuer in its annual filings, interim filings or other reports filed or submitted by it under securities legislation is recorded, processed, summarized and reported within the time periods specified in securities legislation; and

 

(b)designed ICFR, or caused it to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with the issuer’s GAAP.

 

5.1Control framework: The control framework the issuer’s other certifying officer(s) and I used to design the issuer’s ICFR is the Committee of Sponsoring Organizations of the Treadway Commission (COSO) framework (1992).

 

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

 

5.3Limitation on scope of design: N/A
 
 

 

6.Reporting changes in ICFR: The issuer has disclosed in its interim MD&A any change in the issuer’s ICFR that occurred during the period beginning on January 1, 2015 and ended on March 31, 2015 that has materially affected, or is reasonably likely to materially affect, the issuer’s ICFR.

 

Date: May 13, 2015

 

Jennifer Archibald  

Jennifer Archibald

Chief Financial Officer

  

2

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