NASDAQ: CRME TSX: COM VANCOUVER, Nov. 13 /PRNewswire-FirstCall/ --
Cardiome Pharma Corp. (NASDAQ: CRME/TSX:NASDAQ:COM) today reported
financial results for the third quarter ended September 30, 2006.
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, 2006, the exchange rate was CAD$1.00 = US$0.8947.
Corporate Development The following significant events have
occurred since our last quarterly report: - In September 2006, we
announced that RSD1235 has been assigned the name vernakalant
hydrochloride by the United States Adopted Names (USAN) Council.
All future references to RSD1235 (iv) will now be vernakalant (iv),
and references to RSD1235 (oral) will be vernakalant (oral). The
commercial brand name for vernakalant (iv) will be finalized in the
coming months. - In September 2006, we announced positive top-line
results for the two dosing groups for our recently-completed Phase
2a pilot study of vernakalant (oral). - In October 2006, the
Company announced that it filed a short form base shelf prospectus
with securities regulatory authorities in Canada and a
corresponding shelf registration statement with the United States
Securities and Exchange Commission. The short form base shelf
prospectus and U.S. base shelf registration statement became
effective October 23, 2006. These filings provide for the potential
offering in Canada and the United States of up to an aggregate of
US$150 million of common shares from time to time in one or more
offerings over the next 25 months. The term of such future
offerings, if any, will be established at the time of such
offerings. Results of Operations Net loss for the third quarter of
2006 (Q3-2006) was $12.0 million, or $0.23 per share, compared to a
net loss of $29.5 million, or $0.58 per share for the same period
in 2005 (Q3-2005). The decrease in net loss was largely due to the
write-down of intangible assets in fiscal 2005 related to the
discontinuation of our Oxypurinol program for congestive heart
failure. Total revenue for Q3-2006 was $2.4 million, a decrease of
$2.3 million from $4.7 million for Q3-2005. The decrease in revenue
was attributable to decreased licensing fees and research
collaborative fees from our partner Astellas as clinical programs
related to vernakalant (iv) are near completion. Research and
development costs for Q3-2006 were $10.9 million, compared to $9.1
million for Q3-2005. General and administration expenses were $3.9
million, an increase of $2.0 million from $1.9 million in Q3-2005.
The increase was largely due to increased wages and benefits,
consulting and professional fees related to the increased costs of
corporate governance, and expanded business development activities.
Amortization expenses increased to $0.5 million for the quarter
from $0.2 million for Q3-2005. Stock-based compensation, a non-cash
item included in operating expenses, was $2.5 million for the
quarter, as compared to $1.2 million for the same period in 2005.
Liquidity and Outstanding Share Capital As of September 30, 2006,
the Company had cash, cash equivalents and short-term investments
of $49.8 million. As of October 26, 2006, the Company had
53,608,516 common shares issued and outstanding, 4,788,052 common
shares issuable upon the exercise of outstanding stock options at a
weighted-average exercise price of $6.97 per share and 55,789
common shares issuable upon the exercise of outstanding warrants at
a weighted-average exercise price of US$5.12 per share. Conference
Call Notification Cardiome will hold a teleconference and webcast
on Monday, November 13, 2006 at 4:30pm EST (1:30pm PST). Please
dial 866-249-1964 or 416-644-3427 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 presentation. 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
clinical drug programs focused on atrial arrhythmia (intravenous
and oral dosing), 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. An additional Phase 3 study evaluating patients
with post-operative atrial arrhythmia, called ACT 2, and an
open-label safety study evaluating recent-onset AF patients, called
ACT 4, are ongoing. Cardiome and its co-development partner
Astellas Pharma US, Inc. are working toward re-submitting a New
Drug Application for vernakalant (iv) following receipt of a
Refusal to File letter from the FDA in May 2006. 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. 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 UNAUDITED CONSOLIDATED BALANCE SHEETS
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Expressed in Canadian dollars. Prepared in accordance with Canadian
GAAP.
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September 30, December 31, 2006 2005
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Cash and cash equivalents $ 8,865,619 $ 9,304,620 Short-term
investments 40,919,014 64,651,005 Amounts receivable 4,322,781
7,121,712 Prepaid expenses 1,132,876 1,549,590
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Total current assets 55,240,290 82,626,927 Property and equipment
4,521,443 4,357,123 Intangible assets 3,440,327 2,815,189 Deferred
financing costs 229,073 -
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Total assets $63,431,133 $89,799,239
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Current liabilities $11,528,066 $13,012,226 Deferred revenue
448,930 - Long-term portion of deferred leasehold inducement
1,162,689 1,291,232 Future income tax liability 107,000 289,000
Shareholders' equity 50,184,448 75,206,781
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Total liabilities and shareholders' equity $63,431,133 $89,799,239
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CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF OPERATION AND DEFICIT
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For the Three Months Ended For the Nine Months Ended Sept. 30,
Sept. 30, Sept. 30, Sept. 30, 2006 2005 2006 2005
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Statements of Loss and Deficit Revenue Licensing fees $ 448,929 $
1,228,826 $ 1,945,362 $ 3,646,409 Research collaborative fees
1,952,435 3,432,962 5,642,094 9,432,280
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2,401,364 4,661,788 7,587,456 13,078,689
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Expenses Research and development 10,865,235 9,111,841 31,108,896
32,560,836 General and administration 3,889,737 1,913,803 9,990,095
6,030,437 Amortization 458,247 217,362 1,217,664 2,372,036
Write-down of intangible assets - 23,322,608 - 23,322,608
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15,213,219 34,565,614 42,316,655 64,285,917
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Operating loss (12,811,855) (29,903,826) (34,729,199) (51,207,228)
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Other income Interest and other income 688,555 617,149 2,137,698
1,244,031 Foreign exchange gain (losses) 107,793 (3,290,352)
(2,428,164) (1,856,808)
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796,348 (2,673,203) (290,466) (612,777)
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Loss before income taxes (12,015,507) (32,577,029) (35,019,665)
(51,820,005) Future income tax recovery 42,000 3,105,000 182,000
7,082,000
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Net Loss for the period (11,973,507) (29,472,029) (34,837,665)
(44,738,005) Deficit, beginning of period (168,297,459)
(107,324,648) (145,433,301) (92,058,672)
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Deficit, end of period $(180,270,966) $(136,796,677) $(180,270,966)
$(136,796,677)
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Basic and diluted loss per common share(1) $ (0.23) $ (0.58) $
(0.66) $ (0.93)
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Weighted average number of outstanding common shares 53,180,499
51,098,981 52,706,757 47,916,391
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(1) Basic and diluted net income (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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