WINNIPEG, Sept. 27, 2013 /CNW/ - Medicure Inc. ("Medicure" or the "Company") (TSX VENTURE:MPH), (PINKSHEET:MCUJD), a specialty pharmaceutical company, today reported its results from operations for the fiscal year ended May 31, 2013.
Net revenue from the sale of AGGRASTAT finished product for the year ended May 31, 2013 was $2.6 million compared to $2.9 million for the year ended May 31, 2012. Net revenue for the three months ended May 31, 2013 was $768,000 compared to $371,000 for the three months ended May 31, 2012 and $447,000 for the previous quarter ended February 28, 2013.
Changes in annual and quarterly revenues are affected by fluctuations in wholesale purchasing patterns, and inventory adjustments. Hospital demand for AGGRASTAT remained steady compared to previous year. Growth in sales attributed to the addition of new hospitals continues to partially offset the sales decline among historical customers. Much of the annual decline from 2012 is attributed to the overall decline for this drug class. The increase in revenue for the three months ended May 31, 2013 is partially attributable to an increase in the number of new hospital customers using AGGRASTAT which has increased over the past two quarters. The Company's commercial team continues to work on further expanding its customer base.
Total revenue for the year ended May 31, 2013 was $2.6 million compared to $4.8 million for the year ended May 31, 2012, however in fiscal 2012 the Company recorded a one-time, $1.9 million sale of unfinished product
Net loss for the year ended May 31, 2013 was $2.6 million or $0.21 per share, compared to net income of $23.4 million or $1.99 per share for the year ended May 31, 2012. The change in net (loss) income relative to fiscal 2012 is primarily as a result of the gain on settlement of debt in fiscal 2012, which totalled $23.9 million, the $1.9 million sale of unfinished product in fiscal 2012 and higher research and development expenses in fiscal 2013. The increase in research and development expenses experienced during fiscal 2013 is primarily attributed to continued enrolment in the Company's "Shortened Aggrastat Versus Integrilin in Percutaneous Coronary Intervention" ("SAVI-PCI") clinical trial as well the renal dosing study completed in connection with the Company's supplemental new drug application sNDA filing for the high dose bolus (HDB) dosing regimen of AGGRASTAT.
Net loss for the three months ended May 31, 2013 was $706,000 or $0.06 per share, compared to net loss of $975,000 or $0.08 for same quarter of the previous fiscal year and $1.1 million or $0.09 for the previous quarter. The decrease in the net loss is primarily a result of higher sales in the quarter ended May 31, 2013.
At May 31, 2013, the Company had cash totalling $127,000 compared to $1.1 million as of May 31, 2012. The decrease in cash is primarily due to inventory manufacturing purchases made during fiscal 2013 and the increased net loss. Cash flows used in operating activities for the year ended May 31, 2013 were $990,000, compared to cash flows from operating activities of $417,000 for the year ended May 31, 2012.
Effective August 1, 2013, the Company renegotiated its long-term debt and received an additional two-year deferral of principal repayments. Under the renegotiated terms, the loan continues to be interest only with principal repayments now beginning on August 1, 2015 and the loan matures on July 1, 2018.
The Company's ability to continue in operation for the foreseeable future remains dependent upon the effective execution of its business development and strategic plans.
All amounts referenced herein are in Canadian dollars unless otherwise noted.
AGGRASTAT (tirofiban HCl), in combination with heparin, is indicated for the treatment of acute coronary syndrome, including patients who are to be managed medically and those undergoing PTCA or atherectomy. In this setting, AGGRASTAT has been shown to decrease the rate of a combined endpoint of death, new myocardial infarction or refractory ischemia/repeat cardiac procedure. AGGRASTAT has been studied in a setting that included aspirin and heparin.
Administration of AGGRASTAT is associated with an increase in bleeding events classified as both major and minor bleeding events by criteria developed by the Thrombolysis in Myocardial Infarction Study group (TIMI). Most major bleeding associated with AGGRASTAT occurs at the arterial access site for cardiac catheterization. Bleeding is the most common complication encountered during therapy with AGGRASTAT and fatal bleedings have been reported. AGGRASTAT should be used with caution in patients with platelet count less than 150,000/mm3, in patients with hemorrhagic retinopathy, and in chronic hemodialysis patients. Because AGGRASTAT inhibits platelet aggregation, caution should be employed when it is used with other drugs that affect hemostasis. The safety of AGGRASTAT when used in combination with thrombolytic agents has not been established. During therapy with AGGRASTAT, patients should be monitored for potential bleeding. When bleeding cannot be controlled with pressure, infusion of AGGRASTAT and heparin should be discontinued.
AGGRASTAT is a parenteral non-peptide, reversible GP IIb/IIIa receptor antagonist that is marketed in the United States by Medicure Pharma, Inc. Please see the AGGRASTAT Prescribing Information for approved indications, dosage regimens and safety related information. The AGGRASTAT dosing regimen and the treatment setting studied in the SAVI- PCI study have not been approved by the FDA.
About Medicure Inc.
Medicure is a specialty pharmaceutical company focused on the development and commercialization of novel small molecule therapeutics. The primary focus of the Company and its subsidiaries is the marketing and distribution of AGGRASTAT (tirofiban HCl) for acute coronary syndromes in the United States, where it is sold through the Company's US subsidiary, Medicure Pharma, Inc. For more information on Medicure please visit www.medicure.com.
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Forward Looking Information: Statements contained in this press release that are not statements of historical fact, including, without limitation, statements containing the words "believes", "may", "plans", "will", "estimates", "continues", "anticipates", "intends", "expects" and similar expressions, may constitute "forward-looking information" within the meaning of applicable Canadian and U.S. federal securities laws (such forward-looking information and forward-looking statements are hereinafter collectively referred to as "forward-looking statements"). Forward-looking statements are based on the current assumptions, estimates, analysis and opinions of management of the Company made in light of its experience and its perception of trends, current conditions and expected developments, as well as other factors which the Company believes to be relevant and reasonable in the circumstances. Inherent in forward-looking statements are known and unknown risks, uncertainties and other factors beyond the Company's ability to predict or control that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements, and as such, readers are cautioned not to place undue reliance on forward-looking statements. Such risk factors include, among others, the Company's future product revenues, stage of development, additional capital requirements, risks associated with the completion and timing of clinical trials and obtaining regulatory approval to market the Company's products, the ability to protect its intellectual property, dependence upon collaborative partners, changes in government regulation or regulatory approval processes, and rapid technological change in the industry.
Such statements are based on a number of assumptions which may prove to be incorrect, including, but not limited to, assumptions about: general business and economic conditions; the impact of changes in Canadian-US dollar and other foreign exchange rates on the Company's revenues, costs and results; the timing of the receipt of regulatory and governmental approvals for the Company's research and development projects; the availability of financing for the Company's commercial operations and/or research and development projects, or the availability of financing on reasonable terms; results of current and future clinical trials; the uncertainties associated with the acceptance and demand for new products and market competition. The foregoing list of important factors and assumptions is not exhaustive. The Company undertakes no obligation to update publicly or otherwise revise any forward- looking statements or the foregoing list of factors, other than as may be required by applicable legislation. Additional discussion regarding the risks and uncertainties relating to the Company and its business can be found in the Company's other filings with the applicable Canadian securities regulatory authorities or the US Securities and Exchange Commission, and in the "Risk Factors" section of its Form 20F for the year ended May 31, 2013.