Pitavastatin Calcium

WINNIPEG, MB / ACCESSWIRE / November 23, 2023 / Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH)(OTC PINK:MCUJF), a company focused on the development and commercialization of pharmaceuticals and healthcare products for patients and prescribers in the United States market, today announced that the FDA provides complete approval to enroll patients in its pivotal Phase 3 clinical trial to evaluate the use of its investigational product MC-1 for treatment of a rare pediatric disease called pyridox(am)ine 5′-phosphate oxidase (PNPO) deficiency. The study involves approximately 10 patients at sites in the United States and Australia, and the Company is seeking marketing approval initially in those countries. The U.S. Food and Drug Administration ("FDA") has granted both Orphan Drug Designation and Rare Pediatric Disease Designation to MC-1 for the treatment of seizures associated with PNPO deficiency. Additionally, the European Medicines Agency ("EMA") has granted Orphan Drug Designation to MC-1 for the treatment of PNPO deficiency. Under the Food and Drug Administration Safety and Innovation Act (FDASIA) passed into federal law in 2012, the FDA grants a Rare Pediatric Disease Designation for serious and life-threatening diseases in which the serious or life-threatening manifestations primarily affect individuals from birth to 18 years of age, with a prevalence of less than 200,000 people in the United States. If a new drug application ("NDA") for MC-1 for patients with PNPO deficiency is approved, the Company may be eligible to receive a priority review voucher ("PRV") from the FDA, which can be redeemed to obtain priority review for any subsequent marketing application. "MC-1 has the potential to become the first FDA-approved therapy for patients with PNPO deficiency. We sincerely thank all of the clinicians, patients and their families for participating in this study." said Dr. Albert D. Friesen, CEO of Medicure and Chair of its Board of Directors. About Medicure Inc. Medicure is a pharmaceutical company focused on the development and commercialization of therapies for the U.S. cardiovascular market. The present focus of the Company is the marketing and distribution of AGGRASTAT® (tirofiban hydrochloride) injection and ZYPITAMAG® (pitavastatin) tablets in the United States, where they are sold through the Company's U.S. subsidiary, Medicure Pharma Inc. Medicure also operates Marley Drug, Inc. ("Marley Drug"), a pharmacy located in North Carolina that offers an Extended Supply drug program serving all 50 states, Washington D.C. and Puerto Rico. Marley Drug® is committed to improving the health status of its patients and the communities they serve while reducing overall health care costs for employers and other health care consumers. For more information visit . To learn more about The Extended Supply Generic Drug Program call 800.286.6781 or email info@marleydrug.com.For more information on Medicure please visit . For additional information about AGGRASTAT®, please visit or refer to the full Prescribing Information. For additional information about ZYPITAMAG®, please visit or refer to the full Prescribing Information. To receive investor and business updates from Medicure, please fill out this form click here to be added to Medicure's e-mail list. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. 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, include 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, expected results, including future revenue from P5P, the likelihood of receiving a priority review voucher from the United State Food and Drug Administration, expected future growth in 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 current Form 20F. AGGRASTAT® (tirofiban hydrochloride) injection, ZYPITAMAG® (pitavastatin) tablets, and Marley Drug® are registered trademarks. For more information, please contact: Dr. Albert D. Friesen Chief Executive Officer Tel. 888-435-2220 Fax 204-488-9823 E-mail: info@medicure.com SOURCE: Medicure, Inc. View source version on accesswire.com:

WINNIPEG, MB / ACCESSWIRE / November 21, 2023 / Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH)(OTC PINK:MCUJF), a company focused on the development and commercialization of pharmaceuticals and healthcare products for patients and prescribers in the United States market, today reported its results from operations for the quarter ended September 30, 2023. Quarter Ended September 30, 2023 Highlights: Recorded total net revenue of $5.0 million during the quarter ended September 30, 2023 compared to $5.3 million for the quarter ended September 30, 2022 and; Recorded total net revenue from the sale of AGGRASTAT® of $2.4 million during the quarter ended September 30, 2023 compared to $3.0 million for the quarter ended September 30, 2022 and; Recorded total net revenue from the Marley Drug business of $2.2 million ($670,000 from sales of ZYPITAMAG® , and $1.53 million from other pharmacy revenue) during the quarter ended September 30, 2023 compared to $1.8 million ($430,000 from sales of ZYPITAMAG® and $1.37 million from other pharmacy revenue) for the quarter ended September 30, 2022 and; Recorded net revenue through insured business from the sale of ZYPITAMAG®of $398,000 during the quarter ended September 30, 2023 compared to $434,000 through insured business for the quarter ended September 30, 2022. Adjusted earnings before interest, taxes, depreciation and amortization (EBITDA1) for the quarter ended September 30, 2023 was $429,000 compared to adjusted EBITDA of $1.4 million for the quarter ended September 30, 2022 and; Net income for the quarter ended September 30, 2023 was $84,000 or $0.01 per share compared to net income of $1.1 million or $0.11 per share for the quarter ended September 30, 2022. R&D expenses for the quarter ended September 30, 2023 were $508,000, and the company remains committed to the completion of the PNPO deficiency Phase 3 clinical trial. The Company remains cash flow positive and carries no debt on its balance sheet. Financial Results Net AGGRASTAT® product sales for the three month period ended September 30, 2023, were $2.4 million compared to $3.0 million during the three month period ended September 30, 2022. The decrease in AGGRASTAT® revenues from the prior year when compared to the previous year is the result of a decrease in the volume of AGGRASTAT® sold, and competition from generic tirofiban. ZYPITAMAG® contributed $398,000 of revenue for the quarter ended September 30, 2023 compared to $434,000 for the quarter ended September 30, 2022. The decrease in revenue through insured channels is primarily as a result of wholesaler returns and higher coverage gap payments to pharmacy benefit managers. This amount does not include sales of ZYPITAMAG® through the Marley Drug business. The Marley Drug business contributed $2.2 million of revenue for the quarter ended September 30, 2023 compared to $1.8 million for the quarter ended September 30, 2022. Marley Drug is a US pharmacy licensed to ship medications to all 50 states, Washington D.C. and Puerto Rico. It serves thousands of customers and provides another channel for direct-to-consumer marketing, distribution and improved profit margin for ZYPITAMAG®. The increase in revenue is a result of increased sales through its e-commerce platform, including increased sales of ZYPITAMAG®. Adjusted EBITDA for the quarter ended September 30, 2023 was $429,000 compared to $1.4 million for the quarter ended September 30, 2022. Decreased adjusted EBITDA for the quarter ended September 30, 2023 resulted from lower net revenue, higher selling and R&D expenses, partially offset by lower cost of goods sold during the current quarter. Net income for the quarter ended September 30, 2023 was $84,000 or $0.01 per share compared to net income of $1.1 million or $0.11 per share for the quarter ended September 30, 2022. The main factor contributing to the decrease in net income recorded for the quarter ended September 30, 2023 was lower net revenue, higher selling and R&D expenses, partially offset by lower cost of goods sold during the current period. At September 30, 2023, the Company had unrestricted cash totaling $5.6 million, an increase from $4.9 million of unrestricted cash held as of December 31, 2022. Cash flows from operating activities for the nine months ended September 30, 2023 was $1.2 million compared to cash flows from operating activities of $1.3 million for the nine months ended September 30, 2022. All amounts referenced herein are in Canadian dollars unless otherwise noted. The full financial statements are available at and on the Company's website at . Notes The Company defines EBITDA as "earnings before interest, taxes, depreciation, amortization and other income or expense" and Adjusted EBITDA as "EBITDA adjusted for non‑cash and non-recurring items". The terms "EBITDA" and "Adjusted EBITDA", as it relates to the three and nine month periods ended September 30, 2023 and 2022 results prepared using IFRS, do not have any standardized meaning according to IFRS. It is therefore unlikely to be comparable to similar measures presented by other companies. Conference Call Info: Topic: Medicure's Q3 2023 Results Call date: Wednesday, November 22, 2023 Time: 7:30 AM Central Time (8:30 AM Eastern Time) Toll Free: 1 (888) 506-0062 International: 1 (973) 528-0011 Participant Access Code: 599508 Webcast: This conference call will be webcast live over the internet at the following link: You may request international country-specific access information by e-mailing the Company in advance. Management will accept and answer questions related to the financial results and operations during the question-and-answer period at the end of the conference call. A recording of the call will be available following the event at the Company's website. About Medicure Inc. Medicure is a pharmaceutical company focused on the development and commercialization of therapies for the U.S. cardiovascular market. The present focus of the Company is the marketing and distribution of AGGRASTAT® (tirofiban hydrochloride) injection and ZYPITAMAG® (pitavastatin) tablets in the United States, where they are sold through the Company's U.S. subsidiary, Medicure Pharma Inc. Medicure also operates Marley Drug, Inc. ("Marley Drug"), a pharmacy located in North Carolina that offers an Extended Supply drug program serving all 50 states, Washington D.C. and Puerto Rico. Marley Drug® is committed to improving the health status of its patients and the communities they serve while reducing overall health care costs for employers and other health care consumers. For more information visit . To learn more about The Extended Supply Generic Drug Program call 800.286.6781 or email info@marleydrug.com.For more information on Medicure please visit . For additional information about AGGRASTAT®, please visit or refer to the full Prescribing Information. For additional information about ZYPITAMAG®, please visit or refer to the full Prescribing Information. To receive investor and business updates from Medicure, please fill out this form click here to be added to Medicure's e-mail list. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. 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, include 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, expected results, including future revenue from P5P, the likelihood of receiving a priority review voucher from the United State Food and Drug Administration, expected future growth in 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 current Form 20F. AGGRASTAT® (tirofiban hydrochloride) injection, ZYPITAMAG® (pitavastatin) tablets, and Marley Drug® are registered trademarks. For more information, please contact: Dr. Albert D. Friesen Chief Executive Officer Tel. 888-435-2220 Fax 204-488-9823 E-mail: info@medicure.com Condensed Consolidated Interim Statements of Financial Position (expressed in thousands of Canadian dollars, except per share amounts) September 30, 2023 December 31, 2022 Assets Current assets: Cash and cash equivalents $ 5,642 $ 4,857 Accounts receivable 5,531 5,635 Inventories 3,377 3,221 Prepaid expenses 761 1,134 Total current assets 15,311 14,847 Non-current assets: Property and equipment 856 1,187 Intangible assets 9,444 10,624 Goodwill 3,171 3,177 Other assets 63 63 Total non-current assets 13,534 15,051 Total assets $ 28,845 $ 29,898 Liabilities and Equity Current liabilities: Accounts payable and accrued liabilities $ 5,671 $ 7,128 Current portion of royalty obligation - 179 Current portion of acquisition payable 676 677 Current income taxes payable 6 60 Current portion of lease obligation 351 346 Total current liabilities 6,704 8,390 Non-current liabilities Lease obligation 275 503 Total non-current liabilities 275 503 Total liabilities 6,979 8,893 Equity: Share capital 81,014 80,917 Contributed surplus 10,647 10,476 Accumulated other comprehensive income (5,491 ) (5,458 ) Deficit (64,304 ) (64,930 ) Total Equity 21,866 21,005 Total liabilities and equity $ 28,845 $ 29,898 Condensed Consolidated Interim Statements of Net Income and Comprehensive Income (expressed in thousands of Canadian dollars, except per share amounts) Three months ended September 30, 2023 Three months ended September 30, 2022 Nine months ended September 30, 2023 Nine months ended September 30, 2022 Revenue, net $ 5,002 $ 5,287 $ 16,623 $ 16,750 Cost of goods sold 1,362 1,391 4,999 5,034 Gross profit 3,640 3,896 11,624 11,716 Expenses Selling 2,017 1,694 6,123 5,060 General and administrative 1,024 1,036 3,055 3,909 Research and development 508 314 1,703 1,984 3,549 3,044 10,881 10,953 Other Income Change in fair value of contingent consideration - (302 ) - (302 ) Finance (income) costs: Finance (income) expense, net (3 ) 33 (20 ) 90 Foreign exchange (gain) loss, net 17 (10 ) 71 25 14 (279 ) 51 (187 ) Net income (loss) before income taxes $ 77 $ 1,131 $ 692 $ 950 Income tax (recovery) expense Current (7 ) 18 66 39 Net income $ 84 $ 1,113 $ 626 $ 911 Other comprehensive income: Item that may be reclassified to profit or loss Exchange differences on translation of foreign subsidiaries 455 1,257 (33 ) 1,587 Other comprehensive income, net of tax 455 1,257 (33 ) 1,587 Comprehensive income $ 539 $ 2,370 $ 593 $ 2,498 Earnings per share Basic $ 0.01 $ 0.11 $ 0.06 $ 0.09 Diluted $ 0.01 $ 0.11 $ 0.05 $ 0.09 Condensed Consolidated Interim Statements of Cash Flows (expressed in thousands of Canadian dollars, except per share amounts) For the nine months ended September 30 2023 2022 Cash (used in) provided by: Operating activities: Net income for the period $ 626 $ 911 Adjustments for: Change in fair value of contingent consideration (302 ) Recovery of royalties (234 ) - Amortization of property, plant and equipment 319 343 Amortization of intangible assets 1,298 1,171 Share-based compensation 212 50 Finance (income) expense, net 11 90 Unrealized foreign exchange (gain) loss 71 812 Income tax expense 66 39 Change in the following: Accounts receivable 86 (285 ) Inventories (178 ) (61 ) Prepaid expenses 334 203 Accounts payable and accrued liabilities (1,108 ) (865 ) Other assets - 27 Interest received (paid), net 31 10 Income taxes paid (78 ) (42 ) Royalties paid (304 ) (772 ) Cash flows from operating activities 1,152 1,329 Investing activities: Acquisition of intangible assets (142 ) (269 ) Cash flows used in investing activities (142 ) (269 ) Financing activities: Repayment of lease liability (225 ) (219 ) Cash flows used in financing activities (225 ) (219 ) Increase in cash and cash equivalents 785 841 Cash and cash equivalents, beginning of period 4,857 3,694 Cash and cash equivalents, end of period $ 5,642 $ 4,535 SOURCE: Medicure, Inc. View source version on accesswire.com: