Latest news with #Catalent
Business Wire
15-05-2025
- Business
- Business Wire
Prolific Machines Appoints Former Catalent Chief Scientific Officer to Board of Directors
EMERYVILLE, Calif.--(BUSINESS WIRE)--Prolific Machines, the Photomolecular platform leader, today announced the appointment of Julien Meissonnier, former Chief Scientific Officer of Catalent, to its Board as an Independent Director. Meissonnier will leverage his more than 26 years of deep pharmaceutical and life science services expertise to help leading life science innovators leverage Prolific Machines' platform and its expertise. "With the right strategy, investment, innovation, and partnership culture, Prolific stands to be a leading accelerator of biopharma innovation, and I look forward to working with the Board, Deniz and the Prolific team to make this happen." Prolific Machines is leveraging advanced optogenetic technology and artificial intelligence to revolutionize protein production and offer precise, efficient, and scalable solutions for biopharmaceutical manufacturing. The Bay Area company's Photomolecular platform provides direct and dynamic control over any cellular function, in any cell type, to solve biopharma's most complex protein and viral vector manufacturing challenges, maximize titer and provide more consistent quality for biotherapies. Prolific recently completed the world's largest demonstration of optogenetics at 200L scale. 'We are well positioned to deliver impactful solutions to both early-stage biotechs and Big Pharma. Julien's pharma services experience will further accelerate our ability to do this,' said Deniz Kent, Ph.D., Prolific Machines' Co-Founder and CEO. 'I'm particularly excited about using light-based control to manufacture difficult-to-produce biotherapeutics, and I would encourage asset owners with this problem to reach out to us.' Meissonnier brings nearly three decades of leadership in biopharmaceuticals and life science services to Prolific Machines' Board. Most recently, he served as CSO of Catalent, a leading contract development and manufacturing organization (CDMO), where he was responsible for global product development and was a lead contributor to the company's strategic investment in and growth of services for new therapeutic modalities. Through offering novel and targeted development excellence, and drug delivery and manufacturing solutions to accelerate life science innovations, Meissonnier was instrumental in establishing Catalent as one of the largest, most impactful, and fastest-growing pharma services organizations. He is currently an independent advisor to life science investors and innovators. 'Having helped build and scale Catalent's CDMO services and capabilities over two decades, I am excited to support Prolific in leveraging its groundbreaking technology to enable some of the most complex yet promising biotherapeutics in today's development pipeline and ultimately, help them reach clinic,' said Meissonnier. 'With the right strategy, investment, innovation, and partnership culture, Prolific stands to be a leading accelerator of biopharma innovation and I look forward to working with the Board, Deniz and the Prolific team to make this happen.' About Prolific Machines Prolific Machines is redefining biologics manufacturing, offering solutions from benchtop to pre-clinical scale. Founded in 2020, the Bay Area company's pioneering Photomolecular platform brings together advanced optogenetic tools and proprietary closed-loop control capabilities to solve major protein production challenges for early-stage biotechnology and leading pharmaceutical partners. The company is on a mission to create a healthier, more sustainable tomorrow and is supported by leading investors, including Ki Tua Fund, the corporate venture arm of the Fonterra Co-operative Group; Breakthrough Energy Ventures; Mayfield; SOSV; In-Q-Tel; and others. To learn more, visit And to qualify for a risk-free manufacturability assessment, or to become a research partner, contact partners@
Yahoo
08-05-2025
- Business
- Yahoo
Novo Nordisk AS (NVO) Q1 2025 Earnings Call Highlights: Robust Growth Amid Challenges
Sales Growth: 18% in the first three months of 2025. Operating Profit Growth: 20% in the first three months of 2025. US Operations Sales Growth: 17% in the first three months of 2025. International Operations Sales Growth: 19% in the first three months of 2025. GLP-1 Diabetes Sales Growth: 11%, with US operations growing 10% and International Operations growing 13%. Obesity Care Sales Growth: 65%, with US operations growing 40% and International Operations growing 137%. Rare Disease Sales Growth: 3%, with International Operations growing 5% and US operations growing 1%. Gross Margin: Decreased to 83.5% from 84.8% in the first three months of 2024. Net Profit Increase: 14% in the first three months of 2025. Diluted Earnings Per Share: Increased by 15% to DKK6.53. Free Cash Flow: DKK9.5 billion compared to DKK5 billion in the first three months of 2024. Capital Expenditure: DKK13.4 billion compared to DKK8.4 billion in 2024. Return to Shareholders: DKK36.7 billion, mainly as dividends in the first three months of 2025. Warning! GuruFocus has detected 1 Warning Sign with NVO. Release Date: May 07, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Novo Nordisk AS (NYSE:NVO) reported an 18% sales growth and 20% operating profit growth in the first quarter of 2025. The company is serving nearly 46 million patients with diabetes and obesity treatments, an increase of almost 4 million from the previous year. Novo Nordisk AS (NYSE:NVO) completed the pivotal trial REDEFINE 2 for its next-generation obesity treatment, CagriSema, and remains on track for submission in early 2026. The US FDA accepted the application for Wegovy 2.4 mg for treating metabolic dysfunction-associated steatohepatitis (MASH) and granted it priority review. Novo Nordisk AS (NYSE:NVO) has expanded its presence in the US with over 10,000 full-time employees and significant investments in manufacturing sites. Total carbon emissions increased by 37% due to the acquisition of new production sites and capital expenditure activities. The company reduced its full-year outlook due to lower-than-planned branded GLP-1 penetration, impacted by the rapid expansion of compounding in the US. Novo Nordisk AS (NYSE:NVO) faces challenges with unlawful compounding of semaglutide in the US, affecting the uptake of Wegovy prescriptions. The gross margin decreased to 83.5% from 84.8% in the first quarter of 2024, mainly due to amortizations and depreciations related to Catalent. Net financial items showed a net loss of DKK1.8 billion, primarily reflecting losses on hedge currencies and financing costs related to the Catalent transaction. Q: How does Novo Nordisk plan to address the issue of compounding in the US, especially with partnerships like HIMSS? A: David Moore, Executive Vice President, US Operations, stated that Novo Nordisk does not support unlawful compounding and is against illegal importation and continuation of compounding in the US. The company has collaborated with telehealth providers to ensure patients have access to legitimate Wegovy through Novocare Pharmacy. They expect the FDA to enforce the law against unlawful compounding by May 22. Q: What are the expectations for Ozempic growth in International Operations once supply constraints are removed? A: Maziar Doustdar, Executive Vice President, International Operations, explained that Ozempic has been launched in 80 markets and is expected to see accelerated growth as supply constraints are lifted. The company has a 64% volume market share on injectable GLP-1s and plans to continue promoting Ozempic aggressively. Q: Can you provide more details on the impact of compounding on Wegovy market share and the guidance for the second half of the year? A: Karsten Munk Knudsen, Chief Financial Officer, noted that the guidance assumes a significant number of patients on compounded products will switch to branded products in the second half of the year. The company expects to capture patients transitioning from compounded semaglutide to branded Wegovy, supported by cash offerings and telehealth collaborations. Q: How does Novo Nordisk view the competitive landscape with Mounjaro and the potential for Ozempic growth? A: David Moore highlighted that the GLP-1 class continues to grow, and Novo Nordisk is focused on leveraging the broad label of Ozempic. The company has launched a new campaign, "Ozempic Era," to emphasize the benefits of the product and aims to maintain patient retention and increase dosage adherence. Q: What is the outlook for oral semaglutide 25-milligram, and how does Novo Nordisk plan to compete in the oral GLP-1 market? A: Lars Fruergaard Joergensen, CEO, stated that Novo Nordisk is well-positioned to launch oral semaglutide 25-milligram, assuming positive regulatory outcomes. The company believes the oral segment will be smaller than injectables but is confident in competing effectively with a known molecule that offers convenience and efficacy similar to Wegovy. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
08-05-2025
- Business
- Yahoo
Novo Nordisk AS (NVO) Q1 2025 Earnings Call Highlights: Robust Growth Amid Challenges
Sales Growth: 18% in the first three months of 2025. Operating Profit Growth: 20% in the first three months of 2025. US Operations Sales Growth: 17% in the first three months of 2025. International Operations Sales Growth: 19% in the first three months of 2025. GLP-1 Diabetes Sales Growth: 11%, with US operations growing 10% and International Operations growing 13%. Obesity Care Sales Growth: 65%, with US operations growing 40% and International Operations growing 137%. Rare Disease Sales Growth: 3%, with International Operations growing 5% and US operations growing 1%. Gross Margin: Decreased to 83.5% from 84.8% in the first three months of 2024. Net Profit Increase: 14% in the first three months of 2025. Diluted Earnings Per Share: Increased by 15% to DKK6.53. Free Cash Flow: DKK9.5 billion compared to DKK5 billion in the first three months of 2024. Capital Expenditure: DKK13.4 billion compared to DKK8.4 billion in 2024. Return to Shareholders: DKK36.7 billion, mainly as dividends in the first three months of 2025. Warning! GuruFocus has detected 1 Warning Sign with NVO. Release Date: May 07, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Novo Nordisk AS (NYSE:NVO) reported an 18% sales growth and 20% operating profit growth in the first quarter of 2025. The company is serving nearly 46 million patients with diabetes and obesity treatments, an increase of almost 4 million from the previous year. Novo Nordisk AS (NYSE:NVO) completed the pivotal trial REDEFINE 2 for its next-generation obesity treatment, CagriSema, and remains on track for submission in early 2026. The US FDA accepted the application for Wegovy 2.4 mg for treating metabolic dysfunction-associated steatohepatitis (MASH) and granted it priority review. Novo Nordisk AS (NYSE:NVO) has expanded its presence in the US with over 10,000 full-time employees and significant investments in manufacturing sites. Total carbon emissions increased by 37% due to the acquisition of new production sites and capital expenditure activities. The company reduced its full-year outlook due to lower-than-planned branded GLP-1 penetration, impacted by the rapid expansion of compounding in the US. Novo Nordisk AS (NYSE:NVO) faces challenges with unlawful compounding of semaglutide in the US, affecting the uptake of Wegovy prescriptions. The gross margin decreased to 83.5% from 84.8% in the first quarter of 2024, mainly due to amortizations and depreciations related to Catalent. Net financial items showed a net loss of DKK1.8 billion, primarily reflecting losses on hedge currencies and financing costs related to the Catalent transaction. Q: How does Novo Nordisk plan to address the issue of compounding in the US, especially with partnerships like HIMSS? A: David Moore, Executive Vice President, US Operations, stated that Novo Nordisk does not support unlawful compounding and is against illegal importation and continuation of compounding in the US. The company has collaborated with telehealth providers to ensure patients have access to legitimate Wegovy through Novocare Pharmacy. They expect the FDA to enforce the law against unlawful compounding by May 22. Q: What are the expectations for Ozempic growth in International Operations once supply constraints are removed? A: Maziar Doustdar, Executive Vice President, International Operations, explained that Ozempic has been launched in 80 markets and is expected to see accelerated growth as supply constraints are lifted. The company has a 64% volume market share on injectable GLP-1s and plans to continue promoting Ozempic aggressively. Q: Can you provide more details on the impact of compounding on Wegovy market share and the guidance for the second half of the year? A: Karsten Munk Knudsen, Chief Financial Officer, noted that the guidance assumes a significant number of patients on compounded products will switch to branded products in the second half of the year. The company expects to capture patients transitioning from compounded semaglutide to branded Wegovy, supported by cash offerings and telehealth collaborations. Q: How does Novo Nordisk view the competitive landscape with Mounjaro and the potential for Ozempic growth? A: David Moore highlighted that the GLP-1 class continues to grow, and Novo Nordisk is focused on leveraging the broad label of Ozempic. The company has launched a new campaign, "Ozempic Era," to emphasize the benefits of the product and aims to maintain patient retention and increase dosage adherence. Q: What is the outlook for oral semaglutide 25-milligram, and how does Novo Nordisk plan to compete in the oral GLP-1 market? A: Lars Fruergaard Joergensen, CEO, stated that Novo Nordisk is well-positioned to launch oral semaglutide 25-milligram, assuming positive regulatory outcomes. The company believes the oral segment will be smaller than injectables but is confident in competing effectively with a known molecule that offers convenience and efficacy similar to Wegovy. 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
22-04-2025
- Business
- Yahoo
Zelluna Reaches Major Milestone with Manufacturing Process Established in Preparation for Clinical Entry of ZI-MA4-1, its Novel TCR-NK Therapy Targeting Solid Tumours
Oslo, Norway, 22 April 2025 – Zelluna (OSE: ZLNA), a company pioneering allogeneic 'off the shelf' T Cell Receptor based Natural Killer (TCR-NK) cells for the treatment of cancer, has successfully developed, scaled and automated its proprietary manufacturing process for its TCR-NK cell therapies. This milestone represents a major advancement in the Company's preparation for clinical entry to provide life-changing, innovative treatments for patients battling cancer. The proprietary manufacturing process is applicable to any product emerging from the Company's pipeline which means any TCR-NK product can be plugged into the established manufacturing process strengthening Zelluna's dominance of the TCR-NK therapeutic field. Establishing and locking down a manufacturing process marks an essential step towards the production of TCR-NK cell therapies for clinical development and future commercialization. Based on the established manufacturing process, hundreds of doses could be produced from a single manufacturing batch highlighting scalability and low cost of goods potential. Zelluna continues to advance its lead TCR-NK cell therapy candidate ZI-MA4-1 in preparation for a filing in the second half of 2025 to begin clinical development targeting a variety of solid tumours. Zelluna has partnered with Catalent, a leading global contract development and manufacturing organization (CDMO), for process development and manufacturing. Catalent brings significant experience in cell therapy manufacturing in compliance with the highest quality standards. Emilie Gauthy, Head of CMC at Zelluna, commented: 'Today marks an important milestone for Zelluna and a crucial step in the development of our novel off the shelf TCR-NK therapies, giving us the potential to make them widely accessible for patients. For any cell therapy, the complexities and challenges of manufacturing are well known and so establishing an efficient process represents a significant achievement. I am therefore incredibly proud of what our team together with our CDMO partners have achieved in transforming a groundbreaking concept from the laboratory into a tangible lead product ready for clinical development that can potentially benefit a wide cross-section of cancer patients.' The established process has delivered its first TCR-NK cell therapy product in the form of Zelluna's lead asset ZI-MA4-1 targeted at solid tumours, with high standards of purity, potency, and safety, designed to meet the needs of patients while also adhering to the latest regulatory requirements. ZI-MA4-1 has shown promising results in preclinical studies, demonstrating the potential of TCR-NK cells to effectively target and eliminate diverse cancer types, in ways that can overcome cancer escape, and with an anticipated favorable safety profile compared to benchmarked cell-based immunotherapies. The company is now well-positioned to move forward with clinical trials and bring this groundbreaking therapy closer to patients. "We are thrilled to have successfully locked down our TCR-NK cell therapy manufacturing process," said Namir Hassan, CEO of Zelluna. "This pivotal achievement not only demonstrates our capability to produce high-quality, scalable TCR-NK cell therapies, but also underscores our commitment to advancing next-generation immunotherapies that could transform the treatment of solid tumours and improve patient outcomes. This accomplishment is a testament to the exceptional talent and relentless drive of our team and partners." For further information, please contact: Namir Hassan, CEO, Zelluna ASA Email: Phone: +44 7720 687608 Hans Vassgård Eid, CFO, Zelluna ASA Email: Phone: +47 482 48632 About Zelluna ASA Zelluna's mission is to deliver transformative treatments with the capacity to cure advanced solid cancers, in a safe and cost-efficient manner, to patients on a global scale. The Company aims to do this by combining the most powerful elements of the immune system through pioneering the development of 'off the shelf' T cell receptor (TCR) guided natural killer (NK) cell therapies (TCR-NK). The TCR-NK platform offers a unique mechanism of action with broad cancer detection capability to overcome the diversity of tumours and will be used 'off the shelf' to overcome scaling limitations of current cell therapies. The lead program is a world's first MAGE-A4 targeting 'off the shelf' TCR-NK for the treatment of various solid cancers; a pipeline of earlier products follows. The Company is led by a management team of biotech entrepreneurs with deep experience in discovery through to clinical development of TCR and cell-based therapies including marketed products. For more information, please visit Sign in to access your portfolio
Associated Press
14-04-2025
- Business
- Associated Press
OpenText Customers Leverage AI, Cloud and Security Solutions to Drive Transformation and Success
BMO and Catalent Pharma Solutions Partner with OpenText to Transform Business Operations and Drive Innovation WATERLOO, ON, April 14, 2025 /CNW/ -- OpenText™ (NASDAQ: OTEX), (TSX: OTEX) the leader Information Management, helps organizations solve complex global problems and impactful transformation with a comprehensive suite of Business Clouds, Business AI and Business Technology including Security. With innovative information management solutions, including the availability of its latest flagship OpenText Cloud Editions 25.2, OpenText is helping organizations create a new digital labor force and raise human potential and productivity. 'Business is being reimaged with the power of process automation, data and the new Digital Knowledge Worker,' said Mark J. Barrenechea, CEO & CTO of OpenText. 'Information elevates all organizations, and the new digital labor force completes work faster, more accurately, and frees up human talent to drive growth, innovation and efficiencies at greater speed and scale. We are excited to partner with BMO and Catalent to as they drive transformation through Information Management.' OpenText customers are leveraging its comprehensive suite of software and AI to address critical challenges, automate processes, enhance cybersecurity, and drive rapid innovation across all industries. Customer highlights: BMO: Scaling content management for operational excellence BMO, a long-term OpenText partner, scales its information management capabilities to 20 business domains, 13,000 users, and over 60 workflows by leveraging OpenText™ Content Management (Extended ECM), an intelligent enterprise content management solution that securely governs the information lifecycle. BMO's 18-year partnership with OpenText has helped boost collaboration and compliance components across the bank, enabling smarter workflows and seamless customer experiences. 'At BMO, we recognize that information is a foundational aspect of delivering exceptional customer experiences and driving operational excellence. Our partnership with OpenText has been key in enabling us to scale our content management capabilities, enhance collaboration across business domains, and further embrace innovations like AI and cloud computing,' said Alok Daga, CIO of Corporate and Commercial Banking at BMO. 'With the help of OpenText's secure, intelligent platforms, we are not only exceeding our clients' evolving aspirations, but also addressing critical regulatory and cybersecurity challenges.' Catalent Pharma Solutions: A paperless manufacturing vision Catalent is leading a digital transformation as part of its mission to develop, manufacture and supply products that help people live better and healthier lives. This includes ongoing progress in moving to digital workflows and centralizing data across its global manufacturing sites, reducing waste and enhancing efficiency. OpenText's cloud solutions enable Catalent to meet rigorous regulatory requirements, securely and within a private cloud, while supporting its transition to a paperless environment. 'We are proud to partner with OpenText as part of our digital transformation journey as a leading CDMO delivering innovative products for pharma and biotech customers, markets that demand rigorous data management, security, and compliance,' said Lindsay Fernandez, VP of Enterprise Applications at Catalent. 'By embracing end-to-end digital integration of manufacturing processes with OpenText, we are realizing Catalent's vision of a paperless future and building a future-ready digital ecosystem as part of our commitment to driving excellence for our customers, and the patients they serve.' Looking ahead Barrenechea concluded: 'For 30 years OpenText has been automating, and we're going to keep automating within a new era that also leverages the power of AI. Information is being reimagined to serve customers more intelligently than ever before. OpenText World 2024 proved just that, and this year's conference was more than a showcase of innovations; it was a testament to the power of information as the heartbeat of every organization. With AI and information management at the forefront, the future holds limitless potential for those ready to seize it.' OpenText World 2025 will be held in Nashville from November 17 – 20, 2025, and registration is now open. About OpenText OpenText™ is the leading Information Management software and services company in the world. We help organizations solve complex global problems with a comprehensive suite of Business Clouds, Business AI, and Business Technology. For more information about OpenText (NASDAQ/TSX: OTEX), please visit us at Connect with us: OpenText CEO Mark Barrenechea's blog Twitter | LinkedIn Certain statements in this press release may contain words considered forward-looking statements or information under applicable securities laws. These statements are based on OpenText's current expectations, estimates, forecasts and projections about the operating environment, economies and markets in which the company operates. These statements are subject to important assumptions, risks and uncertainties that are difficult to predict, and the actual outcome may be materially different. OpenText's assumptions, although considered reasonable by the company at the date of this press release, may prove to be inaccurate and consequently its actual results could differ materially from the expectations set out herein. For additional information with respect to risks and other factors which could occur, see OpenText's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other securities filings with the SEC and other securities regulators. Readers are cautioned not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Unless otherwise required by applicable securities laws, OpenText disclaims any intention or obligations to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Further, readers should note that we may announce information using our website, press releases, securities law filings, public conference calls, webcasts and the social media channels identified on the Investors section of our website ( ). Such social media channels may include the Company's or our CEO's blog, Twitter account or LinkedIn account. The information posted through such channels may be material. Accordingly, readers should monitor such channels in addition to our other forms of communication. Copyright © 2025 OpenText. All Rights Reserved. Trademarks owned by OpenText. One or more patents may cover this product(s). For more information, please visit OTEX-G View original content to download multimedia: SOURCE Open Text Corporation
