>>Cardiome Reports Second Quarter Results
Wednesday August 8, 4:05 pm ET
VANCOUVER, Aug. 8 /PRNewswire-FirstCall/ - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: 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 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.<<
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I intend to listen to the CC & summarize highpoints soon (probably tomorrow, busy for the rest of the day), unless a biofreak beats me to it. Interested on what the company thinks about the odds of an AC panel for IV vernakalant and what they intend to do with 2nd generation Xigris. I expect both questions to come up on Q&A.
Cheers, Tuck |
