NASDAQ: CRME
TSX: COM
VANCOUVER, Nov. 13 /CNW/ - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today reported financial results for the third quarter ended September 30, 2007. Amounts, unless specified otherwise, are expressed in Canadian dollars and in accordance with Canadian Generally Accepted Accounting Principles (Canadian GAAP). At close of business on September 30, 2007, the exchange rate was CAD$1.00(equal sign)US$1.0052.
Corporate Development
The following significant event occurred since our last quarterly report:
- In August 2007, we announced that the FDA requested that Astellas and
Cardiome participate in a panel review to be conducted by the
Cardiovascular and Renal Drugs Advisory Committee on
December 11-12, 2007. In preparation for the panel, and at the
request of the FDA, Astellas agreed to file additional information
including final safety and efficacy data from the ACT 2 clinical
trial, which was ongoing at the time of the original NDA submission.
As a result of this amendment to the NDA, the FDA indicated that the
action date under the Prescription Drug User Fee Act (PDUFA) will be
extended by three months to January 19, 2008.
Results of Operations
Net loss for the third quarter of 2007 (Q3-2007) was $31.6 million, or $0.50 per share, compared to a net loss of $12.0 million, or $0.23 per share for the same period in 2006 (Q3-2006). The increase in net loss for the third quarter was largely due to increased research and development expenditures related to the vernakalant (oral) clinical activities and increased foreign exchange losses.
Total revenue decreased to $1.0 million in Q3-2007 from $2.4 million in Q3-2006. The decrease in revenue was attributable to decreased research collaborative fees from our partner Astellas.
Research and development costs for Q3-2007 were $15.0 million, compared to $10.9 million for Q3-2006. The increase of $4.1 million in research and development expenditures was primarily due to an increase in costs incurred for our vernakalant (oral) program. General and administration expenses were $4.2 million, an increase of $0.3 million from $3.9 million in Q3-2006. Stock-based compensation, a non-cash item included in operating expenses, was $1.6 million for the quarter, as compared to $2.5 million for the same period in 2006.
Liquidity and Outstanding Share Capital
As of September 30, 2007, we had cash, cash equivalents and short-term investments of $84.6 million.
As of November 5, 2007, we had 63,722,540 common shares issued and outstanding and 5,010,099 common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $8.39 per share.
Conference Call Notification
Cardiome will hold a conference call and webcast on Tuesday, November 13, 2007 at 4:30pm Eastern Time (1:30pm Pacific Time). Please dial 416-340-8010 or 866-540-8136 to access the call. There will be a separate dial-in line for analysts on which we will respond to questions at the end of the call. The webcast can be accessed through Cardiome's website at www.cardiome.com.
About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a product-focused cardiovascular drug development company with two late-stage clinical drug programs focused on atrial arrhythmia (intravenous and oral dosing), a Phase 1 program for GED-aPC, an engineered analog of recombinant human activated Protein C, and a pre-clinical program directed at improving cardiovascular function.
Vernakalant (iv) is the intravenous formulation of an investigational drug being evaluated for the acute conversion of atrial fibrillation (AF). Positive top-line results from two pivotal Phase 3 trials for vernakalant (iv), called ACT 1 and ACT 3, were released in December 2004 and September 2005. Cardiome's co-development partner Astellas Pharma US, Inc. submitted a New Drug Application for vernakalant (iv) in December 2006. Positive top-line results from an additional Phase 3 study evaluating patients with post-operative atrial arrhythmia, called ACT 2, were released in June 2007. An open-label safety study evaluating recent-onset AF patients, called ACT 4, has completed.
Vernakalant (oral) is being investigated as a chronic-use oral drug for the maintenance of normal heart rhythm following termination of AF. Cardiome announced positive results from a Phase 2a pilot study for vernakalant (oral) in September 2006. A Phase 2b study for vernakalant (oral) is ongoing.
In April 2007 Cardiome acquired exclusive worldwide rights for GED-aPC for all indications. Cardiome intends to initially develop GED-aPC in cardiogenic shock, a life-threatening form of acute circulatory failure due to cardiac dysfunction, which is a leading cause of death for patients hospitalized following a heart attack.
Cardiome is traded on the Toronto Stock Exchange (COM) and the NASDAQ National Market (CRME).
Forward-Looking Statement Disclaimer
Certain statements in this press 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. Such forward-looking statements or information involve known and unknown risks, uncertainties and other factors that may cause our actual results, events or developments, or industry results, to be materially different from any future results, events or developments expressed or implied by such forward-looking statements or information. Such factors include, among others, our stage of development, lack of product revenues, additional capital requirements, risk associated with the completion of clinical trials and obtaining regulatory approval to market our products, the ability to protect our intellectual property, dependence on collaborative partners and the prospects for negotiating additional corporate collaborations or licensing arrangements and their timing. Specifically, certain risks and uncertainties that could cause such actual events or results expressed or implied by such forward-looking statements and information to differ materially from any future events or results expressed or implied by such statements and information include, but are not limited to, the risks and uncertainties that: we may not be able to successfully develop and obtain regulatory approval for vernakalant (iv) or vernakalant (oral) in the treatment of atrial fibrillation or any other current or future products in our targeted indications; our future operating results are uncertain and likely to fluctuate; we may not be able to raise additional capital; we may not be successful in establishing additional corporate collaborations or licensing arrangements; we may not be able to establish marketing and sales capabilities and the costs of launching our products may be greater than anticipated; we rely on third parties for the continued supply and manufacture of vernakalant (iv) and vernakalant (oral) and we have no experience in commercial manufacturing; we may face unknown risks related to intellectual property matters; we face increased competition from pharmaceutical and biotechnology companies; and other factors as 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 and uncertainties, 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.
CONDENSED CONSOLIDATED BALANCE SHEETS
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Expressed in thousands of Canadian dollars. September 30, December 31,
Prepared in accordance with Canadian GAAP. 2007 2006
(unaudited)
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Cash and cash equivalents $84,430 $23,400
Short-term investments 147 32,172
Accounts receivable 2,160 3,628
Prepaid expenses and other assets 3,813 869
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Total current assets 90,550 60,069
Property and equipment 4,759 4,427
Intangible assets 24,362 3,203
Deferred financing costs 170 892
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Total assets $119,841 $68,591
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Current liabilities $12,136 $14,618
Long-term portion of deferred
leasehold inducement 989 1,120
Shareholders' equity 106,716 52,853
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Total liabilities and
shareholders' equity $119,841 $68,591
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
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Expressed in thousands For the Three Months For the Nine Months
of Canadian dollars. Ended Ended
Prepared in accordance Sept. 30, Sept. 30, Sept. 30, Sept. 30,
with Canadian GAAP. 2007 2006 2007 2006
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Revenue
Licensing fees $449 $449 $1,347 $1,945
Research
collaborative fees 512 1,952 2,422 5,642
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961 2,401 3,769 7,587
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Expenses
Research and
development 15,029 10,865 36,630 31,109
General and
administration 4,197 3,891 13,644 9,990
Amortization 1,024 458 2,319 1,218
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20,250 15,214 52,593 42,317
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Operating loss (19,289) (12,813) (48,824) (34,730)
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Other income
(expenses)
Interest and
other income 1,132 689 3,836 2,138
Foreign exchange
(loss) gain (13,397) 108 (15,188) (2,428)
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(12,265) 797 (11,352) (290)
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Loss before
income taxes (31,554) (12,016) (60,176) (35,020)
Future income
tax recovery - 42 - 182
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Net Loss for
the period (31,554) (11,974) (60,176) (34,838)
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Basic and diluted
loss per common
share(1) $(0.50) $(0.23) $(0.96) $(0.66)
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Weighted average
number of
outstanding
common shares 63,642,301 53,180,499 62,605,816 52,706,757
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(1) Basic and diluted net loss per common share based on the weighted
average no. of common shares outstanding during the period.
