||United States : Amneal and Impax Complete Business Combination
||Amneal Pharmaceuticals LLC and Impax Laboratories, Inc. ("Impax") announced that they have completed their business combination to form Amneal Pharmaceuticals, Inc. ("Amneal" or the "Company"). As a diversified company with a robust generics business, Amneal is now the 5th largest generics business in the United States, with a growing, high-margin specialty franchise.
Shares of Impax (IPXL) ceased trading on the NASDAQ stock exchange on May 4, 2018. Amneal will begin trading today on the New York Stock Exchange (NYSE) under the ticker "AMRX". Pursuant to the business combination agreement, each share of Impax common stock was converted into the right to receive one share of Amneal Class A common stock.
"We are very excited for the future of Amneal, and strongly believe that with our team, differentiated product portfolio, extensive R&D and manufacturing infrastructure and expertise, Amneal is well positioned to become an industry leader," said Chirag Patel and Chintu Patel, Co-Founders and Co-Chairmen of Amneal. "We are very proud of the Company we have built and look forward to Amneal's continued success under Rob Stewart's leadership."
Robert Stewart, President and Chief Executive Officer of Amneal, said, "As we enter our next stage of growth, we look forward to implementing our integration plans and quickly starting to realize the many benefits of this combination. We will promptly begin to leverage our enhanced product portfolio to fuel organic growth while capturing numerous synergies to unlock value and generate strong cash flow to support the rapid repayment of debt and further investment in growth opportunities."
The Company expects to benefit from its expanded product portfolio, differentiated pipeline and cost-efficient global manufacturing and development capabilities in nearly all dosage forms. Amneal expects to generate annual double-digit revenue and adjusted EPS growth and to achieve annual cost synergies of approximately $200 million within three years.
"This is a truly transformative combination that firmly establishes Amneal as an industry leader, with high-value generic product pipelines and a growing specialty business," said Paul Bisaro, Executive Chairman of Amneal. "With our combined resources, we are well-positioned to execute our plans to bring high-quality, affordable medicines to patients and generate long-term returns for our shareholders."
Review of the Strategic and Financial Benefits of the Combination The Company currently has a generics portfolio with more than 200 differentiated product families marketed in nearly all dosage forms and holds a number one or number two position in a significant number of its marketed products, and has a growing specialty franchise targeting CNS disorders and anti-parasitic infections.
The generic products pipeline is currently one of the largest in the United States, including approximately 149 ANDAs filed at the Food and Drug Administration and 135 projects in active stages of development, with nearly half of all pipeline products exclusive first-to-file, first-to-market or other high-value opportunities with three or fewer competitors estimated at the time of launch. Additionally, the Company has a foundation for commercial entry into biosimilars through in-licensed products in various stages of development.
The Company is committed to ongoing investments in R&D with an expected annual investment of approximately 10% of net revenues, with a focus on the strategic development of high-value products within generics and specialty pharmaceuticals. The Company has an extensive, diversified global supply chain supporting capabilities across nearly all dosage forms including solid oral dose, softgels, injectables, topicals, transdermals, inhalation, complex molecules and drug-device combinations, with R&D and manufacturing sites in the United States, India and Ireland.
The Company expects to generate annual double-digit growth in net revenue, adjusted EBITDA and adjusted EPS over the next three years. The Company expects to achieve significant annual cost saving opportunities of approximately $200 million within three years. The majority of the savings will result from the complementary nature of the companies' combined operations as well as margin-enhancing product transfer opportunities.
The combined companies' debt was refinanced with a $2.7 billion term loan at a rate of three-month LIBOR plus 350 basis points. The Company currently expects that significant cash flow generated by the combination will enable rapid deleveraging, and enable the Company to continue to invest in R&D and high-growth specialty assets.
Amneal Acquires Gemini Laboratories, LLC and Enters Into Biosimilar Partnership with mAbxience S.L. Concurrent with the closing of the business combination, Amneal acquired Gemini Laboratories, LLC, a company focused on marketing and sales of branded pharmaceuticals for $117 million. Gemini's portfolio includes licensed and owned, niche and mature branded products, and a pipeline of 505(b)(2) products for niche therapeutic areas.
Gemini's lead product, Unithroid, is detailed primarily to endocrinologists and high prescribing primary care physicians through a contracted salesforce. Gemini has a long-term distribution agreement for Unithroid with Jerome Stevens Pharmaceuticals. Concurrent with the closing of the business combination, Amneal entered into a licensing agreement for the U.S. market, with MabXience S.L. for its biosimilar candidate for Avastin (bevacizumab). This is the third biosimilar product licensed by Amneal, which demonstrates its commitment to strategically invest and execute in the biosimilar space.
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