NASDAQ: CRME TSX: COM VANCOUVER, Nov. 13 /PRNewswire-FirstCall/ --
Cardiome Pharma Corp. (NASDAQ: CRMENASDAQ:/NASDAQ:TSX:NASDAQ: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=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 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. 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. 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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