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

 

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