Latest news with #regulatoryapprovals
Yahoo
2 days ago
- Business
- Yahoo
Biotricity Inc (BTCY) Q1 2026 Earnings Call Highlights: A Milestone Quarter with Positive ...
Release Date: August 14, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Positive Points Biotricity Inc (BTCY) achieved a significant milestone by reporting positive EBITDA for the first time in its history, indicating a path towards profitability. The company reported a 21% increase in revenue for the first quarter of fiscal 2026, reaching $3.9 million, driven by strong market adoption of its technology. Biotricity Inc (BTCY) has expanded its cardiac AI cloud platform through strategic partnerships with Amazon AWS and Google's Tensorflow, enhancing diagnostic accuracy and patient outcomes. The company has secured regulatory approvals in multiple international markets, including Canada, Saudi Arabia, and Argentina, aligning with its strategy for global expansion. Gross profit for the quarter increased by 31.9% to $3.1 million, with a gross profit margin improvement to 80.5%, reflecting operational efficiencies and a strong recurring revenue base. Negative Points Despite improvements, Biotricity Inc (BTCY) reported a net loss of $754,000 for the first quarter, although this was a significant improvement from the prior year's loss. The company faces challenges with rising variable interest rates, which could impact future financial performance. Biotricity Inc (BTCY) is still in the process of pursuing FDA clearance for its AI clinical model, which could delay the full commercialization of its new technologies. Operating expenses, although reduced, remain a concern as the company continues to invest in R&D and sales force transformation. The company's expansion into new verticals and international markets may require significant resources and could face regulatory and competitive challenges. Q & A Highlights Warning! GuruFocus has detected 6 Warning Signs with BTCY. Q: Can you provide more details on the strategic partnerships mentioned in the call? A: Dr. Walkus Al Sadiq, CEO, highlighted that Biotricity has formed strategic partnerships with industry giants like Amazon AWS and Google's Tensorflow to expand their cardiac AI cloud platform. These partnerships are crucial for enhancing diagnostic accuracy and improving patient outcomes. Additionally, alliances with three major group purchasing organizations (GPOs) in the US provide access to approximately 90% of hospitals, significantly expanding market access. Q: What are the financial highlights for the first quarter of fiscal 2026? A: Johnny Abo, CFO, reported a 21% increase in revenue to $3.9 million compared to the previous year. Gross profit rose by 31.9% to $3.1 million, with a gross profit margin improvement to 80.5%. Operating expenses decreased by 18.5%, and the company achieved a positive EBITDA of $333,000, marking the first quarter of positive EBITDA in Biotricity's history. Q: How is Biotricity addressing the market for atrial fibrillation monitoring? A: The CFO emphasized that atrial fibrillation, a major contributor to strokes, remains a significant focus. Biotricity's technology has monitored over 2 trillion heartbeats, providing early intervention opportunities and improving patient outcomes. This focus not only enhances patient care but also offers potential healthcare cost savings. Q: What are the future growth prospects for Biotricity? A: Dr. Walkus Al Sadiq, CEO, expressed optimism about future growth through the commercialization of products like Biocore Pro, Bioflux, and Biocare. The company is committed to advancing remote monitoring solutions and expanding its geographic footprint, with regulatory approvals in Canada, Saudi Arabia, Argentina, and other markets. Q: How has Biotricity managed to achieve cost efficiencies? A: The CFO explained that cost efficiencies were achieved through strategic transformation of the sales force, focusing on larger accounts and longer sales cycles. Additionally, the use of AI and automation, along with proactive cost management, contributed to positive free cash flows and a path towards profitability. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
Yahoo
2 days ago
- Business
- Yahoo
Biotricity Inc (BTCY) Q1 2026 Earnings Call Highlights: A Milestone Quarter with Positive ...
Release Date: August 14, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Positive Points Biotricity Inc (BTCY) achieved a significant milestone by reporting positive EBITDA for the first time in its history, indicating a path towards profitability. The company reported a 21% increase in revenue for the first quarter of fiscal 2026, reaching $3.9 million, driven by strong market adoption of its technology. Biotricity Inc (BTCY) has expanded its cardiac AI cloud platform through strategic partnerships with Amazon AWS and Google's Tensorflow, enhancing diagnostic accuracy and patient outcomes. The company has secured regulatory approvals in multiple international markets, including Canada, Saudi Arabia, and Argentina, aligning with its strategy for global expansion. Gross profit for the quarter increased by 31.9% to $3.1 million, with a gross profit margin improvement to 80.5%, reflecting operational efficiencies and a strong recurring revenue base. Negative Points Despite improvements, Biotricity Inc (BTCY) reported a net loss of $754,000 for the first quarter, although this was a significant improvement from the prior year's loss. The company faces challenges with rising variable interest rates, which could impact future financial performance. Biotricity Inc (BTCY) is still in the process of pursuing FDA clearance for its AI clinical model, which could delay the full commercialization of its new technologies. Operating expenses, although reduced, remain a concern as the company continues to invest in R&D and sales force transformation. The company's expansion into new verticals and international markets may require significant resources and could face regulatory and competitive challenges. Q & A Highlights Warning! GuruFocus has detected 6 Warning Signs with BTCY. Q: Can you provide more details on the strategic partnerships mentioned in the call? A: Dr. Walkus Al Sadiq, CEO, highlighted that Biotricity has formed strategic partnerships with industry giants like Amazon AWS and Google's Tensorflow to expand their cardiac AI cloud platform. These partnerships are crucial for enhancing diagnostic accuracy and improving patient outcomes. Additionally, alliances with three major group purchasing organizations (GPOs) in the US provide access to approximately 90% of hospitals, significantly expanding market access. Q: What are the financial highlights for the first quarter of fiscal 2026? A: Johnny Abo, CFO, reported a 21% increase in revenue to $3.9 million compared to the previous year. Gross profit rose by 31.9% to $3.1 million, with a gross profit margin improvement to 80.5%. Operating expenses decreased by 18.5%, and the company achieved a positive EBITDA of $333,000, marking the first quarter of positive EBITDA in Biotricity's history. Q: How is Biotricity addressing the market for atrial fibrillation monitoring? A: The CFO emphasized that atrial fibrillation, a major contributor to strokes, remains a significant focus. Biotricity's technology has monitored over 2 trillion heartbeats, providing early intervention opportunities and improving patient outcomes. This focus not only enhances patient care but also offers potential healthcare cost savings. Q: What are the future growth prospects for Biotricity? A: Dr. Walkus Al Sadiq, CEO, expressed optimism about future growth through the commercialization of products like Biocore Pro, Bioflux, and Biocare. The company is committed to advancing remote monitoring solutions and expanding its geographic footprint, with regulatory approvals in Canada, Saudi Arabia, Argentina, and other markets. Q: How has Biotricity managed to achieve cost efficiencies? A: The CFO explained that cost efficiencies were achieved through strategic transformation of the sales force, focusing on larger accounts and longer sales cycles. Additionally, the use of AI and automation, along with proactive cost management, contributed to positive free cash flows and a path towards profitability. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
01-08-2025
- Business
- Yahoo
Regeneron shares edge higher as second quarter earnings surpass estimates
-- Regeneron Pharmaceuticals, Inc. reported second-quarter earnings that significantly exceeded analyst expectations, with adjusted earnings per share reaching $12.89 compared to the $8.43 consensus estimate. Revenue also beat forecasts, coming in at $3.68 billion versus the expected $3.28 billion. The biopharmaceutical company's total revenue increased 4% YoY, driven by strong performance across several key products. Dupixent global net sales, recorded by Sanofi (NASDAQ:SNY), grew 22% to $4.34 billion, while EYLEA HD U.S. net sales jumped 29% to $393 million. However, combined EYLEA HD and EYLEA U.S. net sales decreased 25% to $1.15 billion. The stock is up 0.3% following the results. "Regeneron (NASDAQ:REGN) had a strong quarter, marked by significant growth in U.S. sales of EYLEA HD and global sales of Dupixent and Libtayo along with multiple regulatory approvals," said Leonard Schleifer, Chief Executive Officer of Regeneron. The company reported several regulatory achievements during the quarter, including FDA approval for Lynozyfic for relapsed or refractory multiple myeloma and Dupixent approvals for bullous pemphigoid and chronic spontaneous urticaria. The FDA also accepted for priority review Libtayo's application for adjuvant cutaneous squamous cell carcinoma. Regeneron updated its financial guidance for 2025, adjusting its R&D and SG&A expense projections. The company now expects non-GAAP R&D expenses of $5.1-$5.2 billion and non-GAAP SG&A expenses of $2.45-$2.55 billion. During the quarter, Regeneron returned over $2.3 billion to shareholders through share repurchases and dividends. The company's board declared a cash dividend of $0.88 per share, payable on September 3, 2025. Related articles Regeneron shares edge higher as second quarter earnings surpass estimates These Under-the-Radar Stocks Offer Better Risk-Reward Ratio Than Nvidia Apollo economist warns: AI bubble now bigger than 1990s tech mania Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
National Post
29-07-2025
- Business
- National Post
CI Financial Announces Expected Closing Date for Take-Private Transaction with Mubadala Capital
Article content TORONTO — CI Financial Corp. (' CI ' or the ' Corporation ') (TSX: CIX) is pleased to announce that all regulatory approvals required to close CI's previously announced plan of arrangement under the Business Corporations Act (Ontario) whereby, among other things, an affiliate of funds managed by Mubadala Capital will acquire, directly or indirectly, all of the issued and outstanding common shares of the Corporation (the ' Arrangement ') have now been obtained. The Corporation expects the Arrangement to close on or about August 12, 2025, subject to the satisfaction of the remaining customary conditions to closing. Article content For additional details regarding the Arrangement, see CI's management information circular dated January 7, 2025, a copy of which can be found under CI's issuer profile on SEDAR+ at Article content About CI Financial Article content CI Financial Corp. is a diversified global asset and wealth management company operating primarily in Canada, the United States and Australia. Founded in 1965, CI has developed world-class portfolio management talent, extensive capabilities in all aspects of wealth planning, and a comprehensive product suite. CI operates in three segments: Article content Asset Management, which includes CI Global Asset Management, which operates in Canada, and GSFM, which operates in Australia. Canadian Wealth Management, operating as CI Wealth, which includes CI Assante Wealth Management, Aligned Capital Partners, CI Assante Private Client, CI Private Wealth, Northwood Family Office, CI Coriel Capital, CI Direct Investing, CI Direct Trading and CI Investment Services. U.S. Wealth Management, which includes Corient Private Wealth, an integrated wealth management firm providing comprehensive solutions to ultra-high-net-worth and high-net-worth clients across the United States. Article content CI is headquartered in Toronto and listed on the Toronto Stock Exchange (TSX: CIX). To learn more, visit CI's website or LinkedIn page. Article content About Mubadala Capital Article content Mubadala Capital is a global alternative asset manager that oversees $30 billion USD of assets under management. The firm is an independent subsidiary of Mubadala Investment Company, a c. $330 billion USD global sovereign investor headquartered in Abu Dhabi, UAE. Mubadala Capital manages assets through its four investment businesses spanning various private market strategies, including private equity, special situations, solutions, and venture capital. Mubadala Capital has a team of over 200 spanning 5 offices, including in Abu Dhabi, New York, London, San Francisco, and Rio De Janeiro. Mubadala Capital aims to be the partner of choice for investors looking for attractive and differentiated risk-adjusted returns across various private markets and alternative asset classes. Article content Note Regarding Forward-Looking Statements Article content This press release contains 'forward-looking information' within the meaning of applicable Canadian securities laws. Forward-looking information may relate to our future outlook and anticipated events or results and may include information regarding our financial position, business strategy, growth strategy, budgets, operations, financial results, taxes, dividend policy, plans and objectives. Particularly, information regarding our expectations of future results, performance, achievements, prospects or opportunities, including the completion of the Arrangement and the timing thereof, is forward-looking information. In some cases, forward-looking information can be identified by the use of forward-looking terminology such as 'plans', 'targets', 'expects' or 'does not expect', 'is expected', 'an opportunity exists', 'budget', 'scheduled', 'estimates', 'outlook', 'forecasts', 'projection', 'prospects', 'strategy', 'intends', 'anticipates', 'does not anticipate', 'believes', or variations of such words and phrases or statements that certain actions, events or results 'may', 'could', 'would', 'might', 'will', 'will be taken', 'occur' or 'be achieved'. In addition, any statements that refer to expectations, intentions, projections or other characterizations of future events or circumstances contain forward-looking information. Statements containing forward-looking information are not historical facts but instead represent management's expectations, estimates and projections regarding future events or circumstances. Article content Undue reliance should not be placed on forward-looking information. The forward-looking information in this press release is based on our opinions, estimates and assumptions in light of our experience and perception of historical trends, current conditions and expected future developments, as well as other factors that we currently believe are appropriate and reasonable in the circumstances. Despite a careful process to prepare and review the forward-looking information, there can be no assurance that the underlying opinions, estimates and assumptions will prove to be correct. Further, forward-looking information is subject to known and unknown risks, uncertainties and other factors that may cause actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including, but not limited to, those described in this press release. The belief that the investment fund industry and wealth management industry will remain stable and that interest rates will remain relatively stable are material factors made in preparing the forward-looking information and management's expectations contained in this press release and that may cause actual results to differ materially from the forward-looking information disclosed in this press release. In addition, factors that could cause actual results to differ materially from expectations include, among other things, the possibility that the Arrangement may not be completed, the timing of closing of the Arrangement, the negative impact that the failure to complete the Arrangement for any reason could have on the price of the shares or on the business of the Corporation, general economic and market conditions, including interest and foreign exchange rates, global financial markets, the impact of pandemics or epidemics, changes in government regulations or in tax laws, industry competition, technological developments and other factors described or discussed in CI's disclosure materials filed with applicable securities regulatory authorities from time to time. Additional information about the risks and uncertainties of the Corporation's business and material risk factors or assumptions on which information contained in forward‐looking information is based is provided in the Corporation's disclosure materials, including the Corporation's annual information form dated March 20, 2025 and any subsequently filed interim management's discussion and analysis, which are available under our profile on SEDAR+ at There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. Accordingly, readers should not place undue reliance on forward looking information, which speaks only as of the date made. The forward-looking information contained in this press release represents our expectations as of the date of this news release and is subject to change after such date. CI disclaims any intention or obligation or undertaking to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable law. Article content Article content Article content Contacts Article content CI Financial Article content Article content Article content Article content Jason Weyeneth, CFA Article content Article content 416-681-8779 Article content Article content jweyeneth@ Article content Media Relations Article content Article content Canada Article content Article content Murray Oxby Article content Article content Vice-President, Corporate Communications Article content Article content 416-681-3254 Article content Article content moxby@ Article content United States Jimmy Moock Managing Partner, StreetCred 610-304-4570 jimmy@ ci@ Mubadala Capital Boyd Erman Partner, FGS Longview 416-523-5885 Article content
Yahoo
17-07-2025
- Business
- Yahoo
Vor Bio Appoints Qing Zuraw, M.D. as Chief Development Officer
Dr. Zuraw led clinical development of telitacicept across MG, Sjögren's, SLE, and RA at RemeGen, resulting in multiple regulatory approvals in China; brings deep U.S. and global development experience to support Vor Bio's new development focus and execution of late-stage programs CAMBRIDGE, Mass., July 17, 2025 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, today announced the appointment of Qing Zuraw, M.D., M.P.H., M.B.A., as Chief Development Officer, effective immediately. Dr. Zuraw joins Vor Bio with over 25 years of experience leading complex global and U.S. clinical development programs across autoimmune, inflammatory, and immunologic diseases. Most recently, she served as Chief Development Officer and Head of Global Clinical Development for Autoimmune Diseases at RemeGen Co., Ltd., where she was one of the key leaders of successful development and execution of clinical trials for telitacicept across four key indications—systemic lupus erythematosus (SLE), Sjögren's syndrome, myasthenia gravis (MG), and rheumatoid arthritis (RA)—culminating in regulatory approvals in China for the treatment of SLE, generalized MG and RA. At RemeGen, Dr. Zuraw built and led a cross-functional global team that managed all aspects of telitacicept development, including clinical trial design, regulatory strategy, site engagement, and execution. She played a central role in regulatory interactions with the U.S. Food & Drug Administration, European Medicines Agency, and China's Center for Drug Evaluation, achieving Fast Track, Breakthrough Therapy, and Orphan Drug designations for telitacicept across multiple indications. 'We are delighted to welcome Qing to Vor Bio at a critical time for the company,' said Jean-Paul Kress, M.D., Chief Executive Officer and Chairman of the Board. 'Her deep and diverse clinical development expertise across autoimmune and immunological diseases and with telitacicept will be invaluable as we execute on our late-stage programs. Qing's ability to lead high-performing clinical organizations will be instrumental as we drive forward our global development programs, particularly in the U.S.' Dr. Zuraw has also previously held senior leadership roles at Janssen Research & Development, Teva Pharmaceutical Industries Ltd., Akebia Therapeutics, Inc., Biogen Inc., and Covance, Inc., where she led global clinical development programs across rheumatology, nephrology, respiratory, and immunology. She played a key role in the U.S. FDA approval of Guselkumab for psoriatic arthritis and contributed to multiple NDA and BLA submissions across therapeutic areas. Throughout her career, she has built and led high-performing teams to execute complex trials from early development through post-marketing. 'Vor Bio is uniquely positioned to become a leader in autoimmune therapeutics,' said Dr. Zuraw. 'Having been intimately involved in the development of telitacicept in China from early clinical stages through to multiple approvals, I'm thrilled to join the talented team at Vor Bio to bring telitacicept to patients globally.' About Vor BioVor Bio is a clinical-stage biotechnology company transforming the treatment of autoimmune diseases. The company is focused on rapidly advancing telitacicept, a novel dual-target fusion protein, through Phase 3 clinical development and commercialization to address serious autoantibody-driven conditions worldwide. For more information visit Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words 'aim,' 'anticipate,' 'can,' 'continue,' 'could,' 'design,' 'enable,' 'expect,' 'initiate,' 'intend,' 'may,' 'on-track,' 'ongoing,' 'plan,' 'potential,' 'should,' 'target,' 'update,' 'will,' 'would,' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include Vor Bio's statements regarding Vor Bio's development plans for telitacicept, its ability to change the treatment landscape for patients with autoimmune conditions and other statements that are not historical fact. Vor Bio may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors. These and other risks are described in greater detail under the caption 'Risk Factors' included in Vor Bio's most recent annual or quarterly report and in other reports it has filed or may file with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Vor Bio expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as may be required by law. Media & Investor Contacts:Sarah Spencer+1 857-242-6076investors@ Carl Mauchinvestors@ in to access your portfolio
