VANCOUVER, Aug. 14 /PRNewswire-FirstCall/ - Cardiome Pharma Corp. today reported financial results for the second quarter ended June 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 June 30, 2006, the exchange rate was CAD$1.00 = U.S. $0.8959.
Corporate Development
The following significant events have occurred since our last quarterly report:
- In May 2006, we announced that our co-development partner Astellas Pharma US, Inc. had received a “refusal to file” (RTF) letter from the U.S. Food & Drug Administration (FDA) related to the New Drug Application (NDA) submitted in March 2006 seeking approval to market the intravenous formulation of RSD1235, an investigational new drug for the acute conversion of atrial fibrillation. - In June 2006, we announced the appointment of Curtis Sikorsky to the position of Chief Financial Officer. Mr. Sikorsky, a chartered accountant since 1996, brings over ten years of public and private company experience as well as three years of direct audit and tax experience with a major audit firm. Mr. Sikorsky’s appointment follows the March 2006 promotion of Doug Janzen from Chief Financial Officer to President and Chief Business Officer. Mr. Janzen had filled the role of Acting Chief Financial Officer in the interim. - Subsequent to quarter-end, in July 2006 we announced that representatives from Astellas and Cardiome had met with the FDA to discuss the RTF letter received in May 2006. The meeting was requested by Astellas and Cardiome in order to explore the issues referenced by the FDA within the RTF letter, and to discuss appropriate measures which can be taken to resolve those issues. Astellas and Cardiome have dedicated substantial resources within their clinical and regulatory groups to conducting a comprehensive re-review and audit of the NDA documents and associated databases. The NDA will be re-submitted following completion of this process. - In July 2006, we also announced amendments to our co-development agreement with Astellas, related to the planned re-submission of the NDA for RSD1235 (iv). Under terms of the amended agreement, Astellas has agreed to fund 100% of the costs associated with re-submission of the NDA, including engagement of any external consultants. Astellas has also agreed to modify the timing of the US$10 million NDA milestone, which will now be payable on the date of re-submission. Prior to this amendment, the milestone was conditional on acceptance of the NDA for review. - Also in July 2006, we announced positive interim results for the first of two dosing groups for our Phase 2a pilot study of RSD1235 (oral), suggesting that RSD1235 (oral) appears well-tolerated within the target population, and demonstrating a clear positive trend toward efficacy. Final results from this study are expected in the third quarter of 2006. Results of Operations
Net loss for the second quarter of 2006 (Q2-2006) was $14.7 million, or $0.28 per share, compared to a net loss of $7.7 million, or $0.15 per share for the same period in 2005 (Q2-2005).
Total revenue for Q2-2006 was $2.1 million, a decrease of $1.7 million from $3.8 million for Q2-2005. The decrease in revenue was attributable to decreased licensing fees and research collaborative fees from our partner Astellas.
Research and development costs for Q2-2006 were $11.2 million, compared to $11.9 million for Q2-2005. General and administration expenses were $3.2 million, an increase of $1.0 million from $2.2 million in Q2-2005. The increase was largely due to consulting and professional fees related to the increased costs of corporate governance, and expanded business development activities. Amortization expenses declined to $0.4 million for the quarter from $1.1 million for Q2-2005, following the write-down of intangible assets related to the Oxypurinol development program in the third quarter of 2005. Stock-based compensation, a non-cash item included in operating expenses, was $1.7 million for the quarter, as compared to $1.5 million for the same period in 2005.
Liquidity and Outstanding Share Capital
As of June 30, 2006, the Company had cash, cash equivalents and short-term investments of $57.4 million.
As of July 21, 2006, the Company had 53,049,744 common shares issued and outstanding, 5,114,196 common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $6.42 per share and 71,804 common shares issuable upon the exercise of outstanding warrants at a weighted-average exercise price of US$4.87 per share.
Conference Call Notification
Cardiome will hold a teleconference and webcast on Monday, August 14, 2006 at 4:30pm EST (1:30pm PST). Please dial 800-814-3911 or 416-644-3432 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 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.
RSD1235 (iv) is the intravenous formulation of an investigational drug being evaluated for the acute conversion of atrial fibrillation. Positive top-line results from two pivotal Phase 3 trials for RSD1235 (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 are working toward re-submitting a New Drug Application for RSD1235(iv) following receipt of a Refusal to File letter from the FDA in May 2006.
RSD1235 (oral) is being investigated as a chronic-use oral drug for the maintenance of normal heart rhythm following termination of atrial fibrillation. A Phase 2a pilot study for RSD1235 (oral) was initiated in December 2005. Cardiome announced positive interim results from this study in July 2006.
Cardiome is traded on the Toronto Stock Exchange (COM) and the NASDAQ National Market (CRME). Further information about Cardiome can be found at www.cardiome.com.
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 RSD1235 (iv) or RSD1235 (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 RSD1235 (iv) and RSD1235 (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 UNAUDITED CONSOLIDATED BALANCE SHEETS ------------------------------------------------------------------------- Expressed in Canadian dollars. Prepared in accordance with Canadian GAAP. June 30, December 31, 2006 2005 ------------------------------------------------------------------------- Cash and cash equivalents $ 4,401,148 $ 9,304,620 Short-term investments 53,007,595 64,651,005 Amounts receivable 4,313,898 7,121,712 Prepaid expenses 1,564,246 1,549,590 ------------------------------------------------------------------------- Total current assets 63,286,887 82,626,927 Property and equipment 4,653,428 4,357,123 Intangible assets 2,842,593 2,815,189 ------------------------------------------------------------------------- Total assets $ 70,782,908 $ 89,799,239 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Current liabilities $ 10,699,419 $ 13,012,226 Deferred revenue 897,860 - Long-term portion of deferred leasehold inducement 1,205,873 1,291,232 Future income tax liability 149,000 289,000 Shareholders’ equity 57,830,756 75,206,781 ------------------------------------------------------------------------- Total liabilities and shareholders’ equity $ 70,782,908 $ 89,799,239 ------------------------------------------------------------------------- ------------------------------------------------------------------------- CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF OPERATION AND DEFICIT ------------------------------------------------------------------------- For the Three Months Ended For the Six Months Ended Statements of June 30, June 30, June 30, June 30, Loss and Deficit 2006 2005 2006 2005 ------------------------------------------------------------------------- Revenue Licensing fees $ 448,930 $ 1,215,470 $ 1,496,433 $ 2,417,583 Research collaborative fees 1,685,185 2,591,599 3,689,659 5,999,318 ------------------------------------------------------------------------- 2,134,115 3,807,069 5,186,092 8,416,901 ------------------------------------------------------------------------- Expenses Research and development 11,194,846 11,940,165 20,243,661 23,448,995 General and administration 3,240,665 2,192,394 6,100,358 4,116,634 Amortization 395,172 1,066,523 759,417 2,154,674 ------------------------------------------------------------------------- 14,830,683 15,199,082 27,103,436 29,720,303 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Operating loss (12,696,568) (11,392,013) (21,917,344) (21,303,402) ------------------------------------------------------------------------- ------------------------------------------------------------------------- Other income Interest and other income 679,346 512,685 1,449,143 626,882 Foreign exchange gain (losses) (2,788,449) 968,201 (2,535,957) 1,433,544 ------------------------------------------------------------------------- (2,109,103) 1,480,886 (1,086,814) 2,060,426 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Loss before income taxes (14,805,671) (9,911,127) (23,004,158) (19,242,976) Future income tax recovery 58,000 2,253,000 140,000 3,977,000 ------------------------------------------------------------------------- Net Loss for the period (14,747,671) (7,658,127) (22,864,158) (15,265,976) Deficit, beginning of period (153,549,788) (99,666,521) (145,433,301) (92,058,672) ------------------------------------------------------------------------- Deficit, end of period $(168,297,459) $(107,324,648) $(168,297,459) $(107,324,648) ------------------------------------------------------------------------- ------------------------------------------------------------------------- Basic and diluted loss per common share(1) $ (0.28) $ (0.15) $ (0.44) $ (0.33) ------------------------------------------------------------------------- ------------------------------------------------------------------------- Weighted average number of outstanding common shares 53,010,793 50,848,832 52,468,447 46,301,517 ------------------------------------------------------------------------- ------------------------------------------------------------------------- (1)Basic and diluted net income (loss) per common share based on the weighted average no. of common shares outstanding during the period.
CONTACT: Don Graham, Director of Corporate Communication, (604) 676-6963 or Toll Free: 1-800-330-9928, Email: dgraham@cardiome.com; Peter K. Hofman, Director of Investor Relations, (604) 676-6993 or Toll Free: 1-800-330-9928, Email: phofman@cardiome.com
Cardiome Pharma Corp.
CONTACT: Don Graham, Director of Corporate Communication, (604) 676-6963or Toll Free: 1-800-330-9928, Email: dgraham@cardiome.com; Peter K. Hofman,Director of Investor Relations, (604) 676-6993 or Toll Free:1-800-330-9928, Email: phofman@cardiome.com
