Amneal Announces Strategic European Partnership with Orion Corporation

Rhea-AI Summary

Amneal Pharmaceuticals (NYSE: AMRX) has entered a long-term licensing agreement with Orion Corporation to commercialize complex generic products in Europe, Australia, and New Zealand. This collaboration marks a significant step in Amneal's strategic priority for international expansion. The initial portfolio will consist of existing generic products available in the U.S. and selected pipeline products, with registrations starting in 2023. Financial terms of the deal were not disclosed, but both companies express optimism about the partnership's potential in the second-largest pharmaceutical market.

Positive

• Long-term collaboration with Orion Corporation enhances Amneal's international market reach.
• Access to the significant European, Australian, and New Zealand markets increases growth potential.
• Partnership includes both existing products and high-value pipeline items.

Negative

• None.

- Long-term collaboration to bring Amneal generic products to market in Europe, Australia, and New Zealand

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced it has signed a long-term license agreement with Orion Corporation (OMXH: ORNBV & ORNAV) to commercialize a number of Amneal’s complex generic products.

Under the partnership agreement, Orion is Amneal’s exclusive partner to bring its portfolio of complex generic programs to most parts of Europe as well as in Australia and New Zealand. The initial portfolio will include a mix of generic products commercially available in the U.S. today, as well as select high-value pipeline products currently under development. Initial products will be registered throughout Europe, Australia and New Zealand starting in 2023, with launches expected over the coming years.

Chirag Patel and Chintu Patel, Amneal Co-Chief Executive Officers, stated, “International expansion is a key strategic priority for Amneal and today’s announcement demonstrates our commitment to execute on that. As a company, we are extremely focused on finding partners who share our same values, ethics and ambitions, and we truly could not have found a better European partner than Orion. We are excited to bring our medicines to the second largest global pharmaceutical market, and we hope that today is only the beginning of our work together.”

Liisa Hurme, President & CEO of Orion, stated, “We are delighted to announce this collaboration with Amneal, and we look forward to working together to bring these treatments to patients. This agreement expands our footprint in the European generics market as well as in Asia-Pacific region. In addition, it supports our growth strategy and is yet another fine example how Orion grows its business through high-quality strategic partnerships.”

The financial terms of the agreement were not disclosed.

About Amneal

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals, primarily within the United States. The Company has a diverse portfolio of over 250 products in its Generics segment and is expanding across a broad range of complex products and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceutical products focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more, please visit www.amneal.com.

About Orion Corporation

Orion is a globally operating Finnish pharmaceutical company – a builder of well-being. Orion develops, manufactures and markets human and veterinary pharmaceuticals and active pharmaceutical ingredients. The company is continuously developing new drugs and treatment methods. The core therapy areas of Orion’s pharmaceutical R&D are oncology and pain.

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 or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance, the Company’s growth prospects and opportunities as well as its strategy for growth; product development and launches; the successful commercialization and market acceptance of new products, and expenditures. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words are intended to identify estimates and forward-looking statements.

The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company.

Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; the competition we face in the pharmaceutical industry, in general, specifically from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to obtain exclusive marketing rights for our products; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; our ability to manage our growth through acquisitions and otherwise; our dependence on the sales of a limited number of products for a substantial portion of our total revenues; the continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods and any associated supply chain disruptions; existing and future legal proceedings, the outcome of which are uncertain and may divert management resources and require us to incur substantial defense or settlement payments and costs; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; the impact of severe weather; the impact of the ongoing COVID-19 pandemic, and the emergence of variant strains; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of product liability and other claims against us by consumers and other third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to Food and Drug Administration (“FDA”) product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our dependence on third-party agreements for a portion of our product offerings; the impact of global economic conditions, including any economic effects stemming from adverse geopolitical events, an economic downturn, inflation and rising interest rates; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; our obligations under a tax receivable agreement may be significant; and the high concentration of ownership of our Class A Common Stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230104005120/en/

Anthony DiMeo

Head of Investor Relations

anthony.dimeo@amneal.com

Source: Amneal Pharmaceuticals, Inc.

FAQ

What is the recent licensing agreement between Amneal Pharmaceuticals and Orion Corporation?

Amneal Pharmaceuticals signed a long-term licensing agreement with Orion Corporation to commercialize complex generic products in Europe, Australia, and New Zealand.

How will the licensing agreement impact Amneal Pharmaceuticals (AMRX)?

The licensing agreement is expected to expand Amneal's international market presence and enhance its portfolio with both existing and pipeline products.

When will Amneal's products be registered and launched in Europe, Australia, and New Zealand?

Initial product registrations are set to start in 2023, with launches expected in the following years.

What are the financial terms of the Amneal and Orion agreement?

The financial terms of the licensing agreement have not been disclosed.