Siegfried Holding AG

FRANKFURT, Germany, Sept. 10, 2024 /PRNewswire/ -- Qualifyze, a trusted company in supplier risk management in the Life Sciences industry, today announced $54 million in Series B funding from global software investor Insight Partners, with participation from existing investors HV Capital, HarbourVest Partners, H14 and Cherry Ventures. With the new funding, Qualifyze aims to expand its operations into the US market, continue investing in its go-to-market strategy, and enhance its technology to improve supplier risk management globally. Recognized for its global coverage of reliable and high-quality auditing services, Qualifyze offers an integrated audit management platform that streamlines compliance audits for Life Science companies. With a network of over 250 auditors and quality professionals worldwide, the company has ensured the highest quality compliance standards for over 1,200 companies to date by working alongside industry leaders such as Merck, Moehs, DSM, Olon, Siegfried, Teva, CordenPharma, Cipla, Dr. Reddy's Laboratories, Sun Pharmaceuticals, Sandoz and Mallinckrodt Pharmaceuticals. Qualifyze's platform provides a centralized system to manage every aspect of audits (GxP, ESG, ISO, etc.), including planning, execution, and CAPA follow-ups and closure. By leveraging one of the world's largest databases of pre-existing audit reports and real-time supplier data, Qualifyze allows the quality, procurement, and supply chain functions to assess supplier performance and enable more accurate supplier risk profiling. This enhances overall operational transparency and regulatory adherence and significantly reduces the time and administrative burden typically associated with these processes. From auditing service to trusted risk management partner As the Life Sciences industry evolves, drug manufacturers face increasing safety requirements in their supply chain, making supplier management as crucial as customer relations. According to Gartner's 2024 findings, leading organizations are shifting from mere resilience to "antifragile" supply chains that leverage disruptions for competitive advantage. This shift highlights why effective supply chain risk management is now essential for ensuring long-term success in an increasingly uncertain environment. In response to this trend, Qualifyze drew on data from over 3,000 audits conducted in more than 85 countries to launch its first analytics solutions in 2023. This positioned the company as a key partner in strategic risk management, providing unique insights into global compliance trends and supply chain quality. These tools help drug manufacturers meet compliance standards, gain valuable insights into supplier performance, and manage risks, ultimately resulting in faster time-to-market, lower inventory levels, and reduced Costs of Goods Sold. "We have come a long way from our roots as a third-party auditing organization," said Dr. David Schneider, Founder and CEO of Qualifyze. "Expanding into the US market, forging strategic partnerships, and scaling our global operations are just the start. We're doubling down on enhancing our platform to deliver even more powerful insights for Quality, Procurement, and Supply Chain teams. With this funding, we're positioned to not only lead in supplier risk management but also set new industry standards, driving long-term value and innovation for our clients worldwide." With the goal of accelerating supplier qualification and selection, Qualifyze started issuing a proprietary Quality Compliance Rating (QCR) certificate in 2024. The QCR functions like a scoring system, enabling drug manufacturers to quickly identify the most reliable partners while allowing those partners with superior compliance to stand out from their competitors. Vote of confidence from investors In addition to expanding operations, this new funding will accelerate Qualifyze's mission to become the key partner for strategic supplier risk management in Life Sciences by collecting actionable audit data from every supplier in the world, centralized within one digital platform. "Qualifyze has established itself as a trusted partner for Life Sciences companies by transforming how supplier risk management is approached. We are excited to support David and the Qualifyze team as they expand into the US market and further develop their audit management platform, delivering insights that drive operational excellence and compliance in a complex industry," said Ryan Hinkle, Managing Director at Insight Partners. As part of the transaction, Hinkle will join Qualifyze's board of directors. About Insight Partners Insight Partners is a global software investor partnering with high-growth technology, software, and Internet startup and ScaleUp companies that are driving transformative change in their industries. As of December 31, 2023, the firm has over $80B in regulatory assets under management. Insight Partners has invested in more than 800 companies worldwide and has seen over 55 portfolio companies achieve an IPO. Headquartered in New York City, Insight has offices in London, Tel Aviv, and the Bay Area. Insight's mission is to find, fund, and work successfully with visionary executives, providing them with tailored, hands-on software expertise along their growth journey, from their first investment to IPO. For more information on Insight and all its investments, visit insightpartners.com or follow us on X @insightpartners. About Qualifyze Founded in 2019, Qualifyze is a leading company in supply chain risk management in the Life Sciences industry, trusted by over 1,200 pharmaceutical and healthcare companies globally. Its suite of digital solutions connects manufacturers, suppliers, and a global network of more than 250 auditors and quality experts for a more streamlined collaboration. With a track record of over 3,000 audits across 85+ countries and the largest and most accurate supplier network and data analytics tools, Qualifyze stands as the all-in-one partner for quality compliance and supply chain risk management processes in the Life Sciences sector. SOURCE Qualifyze

By focusing on early-phase CDMO services, Siegfried aims to bolster its drug substance pipeline. Credit: H_Ko / Shutterstock. Switzerland-based Siegfried has announced the signing of binding agreements with Curia Global to acquire an early-phase contract development and manufacturing organisation (CDMO) site in Grafton, Wisconsin, US to strengthen its drug substances service offering. The strategic move will enhance Siegfried’s capabilities and geographical coverage in the sector. The Grafton site, which has 80 experienced employees, specialises in early-phase development and manufacturing services. Siegfried plans to transform the site into a top-tier hub for early-phase CDMO services for its international clientele, including the management of highly potent active pharmaceutical ingredients (APIs). The company’s expansion into the US pharmaceutical market will enable it to provide extensive support to customers throughout the pre-clinical and clinical development stages of drug substances. See Also: Monlunabant by Inversago Pharma for Obesity: Likelihood of Approval Monlunabant by Inversago Pharma for Metabolic Syndrome: Likelihood of Approval The acquisition could particularly be beneficial for small and medium-sized pharmaceutical companies, expanding Siegfried’s range of offerings. By focusing on early-phase CDMO services, Siegfried will bolster its drug substance pipeline, capturing promising opportunities at their inception. The deal will conclude in July 2024. The financial aspect of the acquisition will be managed using existing funds, and Siegfried has confirmed that the outlook for 2024 and mid-term financial targets will remain unaffected by this transaction. Siegfried interim CEO and chief financial officer Reto Suter stated: “With this acquisition, we enhance our offering with early-stage development services for drug substances and become even more relevant and attractive to our customers. “Siegfried now offers an integrated range of services from early-stage development to commercial production of APIs through to the manufacturing of fully formulated drug products. This transaction will generate attractive opportunities and will further accelerate our growth story.”

Wolfgang Wienand will become Lonza's new CEO as the CDMO giant prepares to reap benefits from a major acquisition and a U.S. draft bill that threatens to take out some key competitors from China. Lonza’s search for a CEO has led the Swiss CDMO giant to its compatriot competitor, Siegfried. Lonza has poached Siegfried’s helmsman Wolfgang Wienand as its own CEO, the company said Tuesday. The appointment will take effect in the summer of 2024. Albert Baehny, who temporarily stepped in from his chairman position in October after Pierre-Alain Ruffieux abruptly left, will retire from Lonza after a transition period. Baehny plans to cede his chairman title to Heineken Chairman Jean-Marc Huët at Lonza’s upcoming annual shareholder meeting in May. The appointment follows years of leadership instability marked by multiple CEO handovers since Richard Ridinger left in early 2019. The transition also comes as the CDMO giant prepares to reap benefits from a major new acquisition and a U.S. draft bill that threatens to take out some key competitors from China. About two weeks ago, Lonza unveiled a $1.2 billion deal to acquire a large biologics manufacturing facility from Roche’s Genentech in Vacaville, California, plus plans to invest another 500 million Swiss francs ($550 million) to upgrade the site in the next few years. The deal comes with a contract to continue supplying Roche with drugs currently produced at the site over the medium term. Based on Lonza’s existing mammalian drug substance capacity and its estimated contribution to the firm’s overall business , William Blair analysts figure the company can generate about 1.6 billion Swiss francs ($1.8 billion) in revenue per year at the acquired Vacaville facility, which has bioreactor capacity of about 330,000 liters. The facility helps make some of Roche’s key antibody drugs. It serves as the primary manufacturing location for the Swiss pharma’s top-selling product, multiple sclerosis therapy Ocrevus, which brought in 6.4 billion Swiss francs in sales last year. Roche has reserved about 30% of the site’s capacity for its needs next year. Thanks to the deal, Lonza has dialed up its 2024-2028 guidance to now expect sales to grow around 12% to 15% annually, on average, at constant exchange rates. Last year, the company recorded 6.7 billion Swiss francs in total sales. Meanwhile, Lonza appears on track to snatch more CDMO business as a proposed U.S. bill dubbed the BIOSECURE Act raises questions over whether the Chinese CRO-CDMO duo, WuXi AppTec and WuXi Biologics, will be able to serve U.S. customers. The bill still has a long way to go in the U.S. lawmaking process, but it’s achieving its intended goal, which is to force drug manufacturing back to the U.S., the Williams Blair team pointed out in a Tuesday note. Regardless of whether the BIOSECURE Act succeeds or not, the perceived risk of a crackdown is pushing drug developers away from Chinese CROs and CDMOs moving forward, the analysts said. Lonza is poised to benefit from the BIOSECURE Act given it provides similar services as the Chinese companies. These include support work for small molecules, biologics, and cell and gene therapies.  By William Blair’s estimates, should U.S. customers choose to abandon the WuXi companies, Lonza stands to grab $2.1 billion of the total $5.6 billion revenue that WuXi AppTec got from U.S. customers in 2023 and $800 million of the $2.4 billion tied to WuXi Biologics’ U.S. business. Now, Wienand will take the reins of Lonza to ride these tailwinds. The 14-year Siegfried veteran brings “proven leadership capabilities” and “a wealth of knowledge and experience to Lonza, complemented by his deep scientific and strategic expertise,” Baehny said in a statement.