NASDAQ: CRME TSX: COM VANCOUVER, Aug. 8 /PRNewswire-FirstCall/ --
Cardiome Pharma Corp. (NASDAQ: CRMENASDAQ:/NASDAQ:TSX:NASDAQ:COM)
today reported financial results for the second quarter ended June
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 June
30, 2007, the exchange rate was CAD$1.00=US$0.9386. Corporate
Development The following significant events have occurred since
our last quarterly report: - In May 2007, we announced that
Astellas Pharma Canada, Inc., an affiliate of our co-development
partner, Astellas Pharma US, Inc., filed a New Drug Submission
(NDS) with the Therapeutic Products Directorate of Health Canada
seeking Canadian approval to market the intravenous formulation of
vernakalant (iv). - In June 2007, we and our co-development partner
Astellas announced positive results from our Phase 3 clinical
study, called ACT 2. The trial evaluated the efficacy and safety of
vernakalant (iv) for the treatment of patients who developed atrial
fibrillation or atrial flutter between 24 hours and 7 days
following coronary artery bypass graft (CABG) or valve replacement
surgery. Results of Operations Net loss for the second quarter of
2007 (Q2-2007) was $14.6 million, or $0.23 per share, compared to a
net loss of $14.7 million, or $0.28 per share for the same period
in 2006 (Q2-2006). Total revenue decreased to $1.1 million in
Q2-2007 from $2.1 million in Q2-2006. The decrease in revenue was
attributable to decreased research collaborative fees from our
partner Astellas as clinical programs related to vernakalant (iv)
near completion. Research and development costs for Q2-2007 were
$9.8 million, compared to $11.2 million for Q2-2006. The decrease
of $1.4 million in research and development expenditures was
primarily due to a decrease in costs incurred for our vernakalant
(iv) programs and higher costs in Q2-2006 related to manufacturing
and other costs related to the Phase 2a pilot study for vernakalant
(oral). General and administration expenses were $4.8 million, an
increase of $1.6 million from $3.2 million in Q2-2006. The increase
was primarily due to increased wages and benefits with the addition
of personnel in support of expanded business development and
operational activities. Stock-based compensation, a non-cash item
included in operating expenses, was $2.1 million for the quarter,
as compared to $1.7 million for the same period in 2006. Liquidity
and Outstanding Share Capital As of June 30, 2007, we had cash,
cash equivalents and short-term investments of $100.4 million. As
of July 30, 2007, we had 63,518,492 common shares issued and
outstanding and 5,142,983 common shares issuable upon the exercise
of outstanding stock options at a weighted-average exercise price
of $8.22 per share. Conference Call Notification Cardiome will hold
a conference call and webcast on Wednesday, August 8, 2007 at 4:30
pm EDT (1:30 pm PDT). Please dial 866-540-8136 or 416-340-8010 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
http://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 http://www.sec.gov/ and the Canadian securities
regulatory authorities at http://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. June 30, December 31,
Prepared in accordance with Canadian GAAP. 2007 2006 (unaudited)
(audited)
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Cash and cash equivalents $14,683 $23,400 Short-term investments
85,698 32,172 Accounts receivable 4,153 3,628 Prepaid expenses and
other assets 4,525 869
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Total current assets 109,059 60,069 Property and equipment 4,870
4,427 Intangible assets 24,849 3,203 Deferred financing costs - 892
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Total assets $138,778 $68,591
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Current liabilities $10,483 $14,618 Long-term portion of deferred
leasehold inducement 1,033 1,120 Shareholders' equity 127,262
52,853
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Total liabilities and shareholders' equity $138,778 $68,591
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
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Expressed in thousands For the Three Months For the Six Months of
Canadian dollars. Ended Ended Prepared in accordance June 30, June
30, June 30, June 30, with Canadian GAAP. 2007 2006 2007 2006
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Revenue Licensing fees $449 $449 $898 $1,496 Research collaborative
fees 649 1,685 1,910 3,690
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1,098 2,134 2,808 5,186
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Expenses Research and development 9,771 11,195 21,601 20,244
General and administration 4,831 3,240 9,447 6,100 Amortization 824
395 1,295 759
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15,426 14,830 32,343 27,103
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Operating loss (14,328) (12,696) (29,535) (21,917)
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Other income Interest and other income 1,297 679 2,704 1,449
Foreign exchange loss (1,555) (2,788) (1,791) (2,536)
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(258) (2,109) 913 (1,087)
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Loss before income taxes (14,586) (14,805) (28,622) (23,004) Future
income tax recovery - 58 - 140
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Net Loss for the period (14,586) (14,747) (28,622) (22,864)
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Basic and diluted loss per common share(1) $(0.23) $(0.28) $(0.46)
$(0.44)
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Weighted average number of outstanding common shares 63,370,297
53,010,793 62,133,737 52,468,447
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(1) Basic and diluted loss per common share based on the weighted
average no. of common shares outstanding during the period.
CONTACT: Peter K. Hofman, Senior Director, Investor Relations,
(604) 676-6993 or Toll Free: 1-800-330-9928, Email: DATASOURCE:
Cardiome Pharma Corp. CONTACT: Peter K. Hofman, Senior Director,
Investor Relations, (604) 676-6993 or Toll Free: 1-800-330-9928,
Email:
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