Amneal acquires Kashiv BioSciences, creating global biosimilars leader
The transaction brings together complementary R&D, manufacturing and commercial capabilities, positioning the company to accelerate biosimilar launches, expand patient access and capitalise on growing biologic loss-of-exclusivity opportunities
Bridgewater: Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) today announced the completion of its acquisition of Kashiv BioSciences, LLC (“Kashiv”), creating a fully integrated global biosimilars leader with end-to-end capabilities across research, development, manufacturing and commercialisation. The combination establishes one of the industry’s few fully integrated biosimilars platforms.
“The completion of this acquisition marks a pivotal step in Amneal’s strategy to become America’s #1 Affordable Medicines company,” said Chirag Patel, Co-Founder and Co-Chief Executive Officer. “With this acquisition, we have created an integrated biosimilars business that can launch multiple biosimilars each year and extends our growth profile into the next decade.”
“We are pleased to welcome the Kashiv team to Amneal and thank our shareholders and other stakeholders for their strong support,” said Chintu Patel, Co-Founder and Co-Chief Executive Officer. “This acquisition helps to position Amneal to capitalise on an unprecedented wave of biologic loss of exclusivity. Together, we will pursue this significant opportunity and work to expand patient access to high-quality, affordable biologic medicines.”
Strategic combination
The acquisition combines Kashiv’s biologics research, development and manufacturing capabilities with Amneal’s commercial scale, establishing biosimilars as a major long-term growth pillar within the Company’s Affordable Medicines business.
The transaction provides Amneal access to the global biosimilars market, with more than $300 billion in projected global biologics loss of exclusivity over the next decade. The combined portfolio is expected to support a consistent cadence of biosimilar launches for years to come.
Integration and next steps
The transaction builds on a relationship between Amneal and Kashiv spanning more than a decade, providing a strong foundation for integration. Integration planning and related activities are underway and are focused on combining the companies’ development and manufacturing capabilities and advancing the biosimilar pipeline.
Goldman Sachs & Co. LLC served as financial adviser, and Richards, Layton & Finger, P.A. served as legal counsel to the Committee of Independent Directors of the Board of Directors. Simpson Thacher & Bartlett LLP served as legal counsel, among other financial and compliance advisers, to Amneal.
J.P. Morgan Securities LLC served as financial adviser, Holland & Knight LLP served as legal counsel, and Dhinal Shah Associates served as an adviser in India to Kashiv.
About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, New Jersey, is a diversified, global biopharmaceutical company focused on expanding access to affordable and innovative medicines.
Amneal was founded in 2002 by brothers and Co-CEOs Chirag and Chintu Patel and was built on the belief that innovation only matters if it is accessible. Today, Amneal has a diverse and growing portfolio of approximately 300 complex generic, specialty and biosimilar medicines, delivering more than 160 million prescriptions annually, primarily in the United States.
Its Affordable Medicines segment spans retail generics, injectables and biosimilars. Its Specialty segment provides branded treatments in neurology, including Parkinson’s disease and migraine, and endocrinology. Its AvKARE segment distributes pharmaceuticals and medical products to U.S. federal, retail and institutional customers.
About Kashiv BioSciences
Kashiv BioSciences, LLC is a vertically integrated biopharmaceutical company with numerous commercial and advanced clinical-stage assets and is among the few U.S.-based companies to both manufacture and receive marketing authorisation for multiple biosimilars.
Kashiv BioSciences, LLC in the U.S., together with its subsidiaries in India (collectively, “Kashiv BioSciences”), operates with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory and IP capabilities.
Kashiv BioSciences believes that its people, partners and shared purpose fuel its work to advance patient care and access to important medicines.
Cautionary statement on forward-looking statements
Certain statements contained herein regarding matters that are not historical facts may be forward-looking statements, as defined in the U.S. Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results or forecasts for the future, including, among other things, the Company’s growth profile; its ability to obtain approval for and launch biosimilars and the frequency of such launches; its ability to become America’s #1 Affordable Medicines company; its ability to capitalise on losses of exclusivity; its ability to expand patient access to medicines; its integration prospects; its ability to create value for shareholders; and other non-historical statements.
Words such as “plans,” “expects,” “will,” “anticipates,” “estimates” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements.
The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events, including future market conditions, company performance and financial results, operational investments, business prospects, new strategies and growth initiatives, the competitive environment, the integration of research, development, manufacturing and commercialisation capabilities, and other events.
If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of the Company.
Such risks and uncertainties include, but are not limited to, the Company’s ability to successfully integrate Kashiv; successfully develop, license, acquire, obtain approval for and commercialise new products on a timely basis; competition in the pharmaceutical and biologics industry; supply-chain disruptions; regulatory and legislative changes; cybersecurity incidents and risks associated with artificial intelligence; the ability to attract and retain highly skilled personnel; changes in healthcare reforms, coverage and reimbursement levels; the ability to identify and integrate acquisitions; global economic and political uncertainties; indebtedness and interest-rate fluctuations; and other risks described in the Company’s filings with the Securities and Exchange Commission.
Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. The Company undertakes no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.
