Hikma Pharmaceuticals Regulatory News (HIK)

London, 21 April 2022 - Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, today announces that it has completed its acquisition of Custopharm Inc. ('Custopharm') from Water Street Healthcare Partners ('Water Street'), following approval from the US Federal Trade Commission.

As previously announced on 27 September 2021, Hikma has acquired Custopharm for an initial cash consideration of $375 million on a debt and cash-free basis, with a further $50 million in contingent consideration payable upon the achievement of certain commercial milestones.

Hikma is the second-largest supplier by volume of generic sterile injectable medicines used by US hospitals and health care providers. The combination with Custopharm enhances Hikma's R&D capabilities and pipeline and expands Hikma's differentiated US portfolio to close to 130 commercialised injectable medicines - a more than fivefold increase over the last decade. 

Transaction highlights and strategic rationale:

· Complements Hikma's product portfolio and pipeline, adding up to 13 approved products and additional pipeline products

· Enhances Hikma's R&D capabilities, adding an experienced scientific team of dedicated R&D professionals with a proven ability to develop and commercialise complex sterile injectable products and a state-of-the-art R&D laboratory in California

· Maintains Hikma's strong regulatory track record. Custopharm has consistently obtained regulatory approval for new products with four first-to-market FDA ANDA approvals, including one CGT exclusivity for Calcitonin Salmon, which was launched in May 2021

Siggi Olafsson, Chief Executive Officer of Hikma, commented:

"The acquisition of Custopharm immediately strengthens our already strong US injectables business by adding an attractive and profitable portfolio of marketed products, an exciting pipeline of future opportunities, and a first-class scientific team with a strong regulatory track record. This acquisition is highly complementary to our existing business and places us in an excellent position to better serve the growing needs of hospitals, doctors and patients. I am excited to welcome the team at Custopharm to Hikma as we continue to grow and strengthen our Injectables business."

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About Hikma(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated BBB-/stable S&P and BBB-/stable Fitch)

Hikma helps put better health within reach every day for millions of people around the world. For more than 40 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across the United States (US), the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 8,700 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit: www.hikma.com