News Column

Actavis Provides Outlook for Continued Long-Term Growth

February 5, 2014

Actavis plc, a global specialty pharmaceutical company, provided a detailed look into the company's newly restructured global commercial operations, expanded pipeline and outlook for continued long-term growth during its fifth annual Investor Meeting in New York.

According to a release, in conjunction with the meeting, the Company reiterated that it expects 2013 non-GAAP earnings per diluted share to be modestly above the high-end of its previous forecast. The Company expects full year 2014 revenues above $10 billion, and full year 2014 non-GAAP earnings per diluted share to be between $12.60 and $13.10.

"Today, Actavis stands as a premier, global specialty pharmaceutical company, powered by a strong global commercial presence, unparalleled pipeline, industry-leading supply chain and a strong and flexible financial foundation that is well-positioned for continued long-term growth," said Paul Bisaro, Chairman and CEO of Actavis. "As we move into the next stage of our Company's evolution, we are committed to continuing to grow our business in all of the markets and therapeutic categories in which we operate around the world."

Actavis delivered its most successful year ever in 2013, powered by strong performance in the U.S. and across the Company's global commercial network. Actavis' global generics business today is positioned in the top 10 in more than 25 markets across the world. 2013 was also another transformative year for Actavis' specialty brands business, highlighted by the acquisition of Warner Chilcott plc. The combination created the third-largest specialty pharmaceutical business in the U.S. focused on the core therapeutic categories of Women's Health, Urology, Gastroenterology and Dermatology.

"2013 was a landmark year for Actavis -- our first full year operating as a combined company following the combination of Watson and Actavis," said Siggi Olafsson, President, Actavis Pharma. "With the integration of our two companies completed, we leveraged our newly strengthened global business to drive growth by launching more than 1,000 products around the world, including the key launches of generic versions of Suboxone tablets, Lidoderm, Cymbalta and Zovirax in the U.S.

"The acquisition of Warner Chilcott more than doubled Actavis' specialty brands portfolio and delivered an industry leading pipeline with more than 25 products in various stages of development. The combination created a global leader in Women's Health, bolstered our Urology business, established a platform for continued expansion into the Gastroenterology and Dermatology therapeutic categories and provides the opportunity to introduce a broader portfolio of new products in Actavis' expanded global footprint.

"With integration now substantially completed -- including a restructuring of our U.S. sales organization, the rationalization of R&D projects and personnel and the appointment of new general managers to lead key therapeutic areas in the U.S. -- Actavis' Specialty Brands business is excellently positioned for continued growth in the years ahead.

"Growth during 2013 was driven by the launch of the Warner Chilcott products Delzicol, Minastrin 24 Fe and Doryx 200mg, as well as continued strong sales of core products, including the Rapaflo and Generess Fe franchises, which saw double digit prescription growth on a year-over-year basis. We also saw key product approvals in several markets around the world, including Oxytrol OTC and Crinone 8 percent in the U.S., Fibristal and LoLo in Canada, Rapaflo in Brazil and Levosert in the UK and additional European countries.

"In 2014, we plan to continue our strategy to drive worldwide growth across our global business by improving our position in key markets and further expanding our portfolio. We are committed to optimizing the potential of our global commercial network to deliver the right products, to the right customers in all of our markets around the world."

"We saw remarkable execution within our R&D operations, expanding our robust pipeline for the future with more than 750 filings across the globe, including an industry-leading 53 Abbreviated New Drug Applications (ANDAs) filed in the United States, and we believe we confirmed 18 new first-to-file applications last year," said Fred Wilkinson, President, Actavis Global Research and Development. "We took significant steps to dramatically enhance the number of projects in our U.S. injectable product pipeline and in the inhalation category, and we continue to focus on complementing our development pipeline of solid oral dosage products with more complex modified-release and other dosage forms that enhance our ability to offer distinctive products to our customers around the world, and create sustainable value for our shareholders and our employees.

"Today, our near-term Specialty Brand pipeline includes Levosert in the U.S., which has successfully completed Phase III trials and is expected to have a New Drug Application (NDA) submitted to the FDA in 2014, with a potential launch in 2015. Our development partner filed metronidazole gel 1.3 percent, with an approval anticipated in 2014. Diafert is in Phase III trials with a filing expected in 2014. We are also continuing to actively pursue biosimilar products internally and through our ongoing collaboration with Amgen, with three products: biosimilar Herceptin, biosimilar Avastin and rFSH now in Phase III trials.

Actavis' global operations continued their strong and consistent execution in 2013, driving the success of our global business. Anda distribution also had another strong year, with top and bottom-line growth bolstered by increased sales of third-party brand products and higher sales to chain customers.

"With the addition of four new facilities gained through the acquisition of Warner Chilcott, our global manufacturing network now operates more than 30 facilities representing a combined manufacturing capacity of approximately 44 billion units," said Robert Stewart, President, Actavis Global Operations. "We have enhanced capabilities in modified release solid dosage, semi- solids, transdermals, liquids and injectables, and are responsible for producing more than 1,100 generic products and more than 30 branded products around the world. The addition of Warner Chilcott's facilities in Puerto Rico also provided us with potentially significant savings by providing a tax-advantaged domain for the registration of new intellectual property."

"In 2013, we continued to make progress on initiatives to rationalize our supply chain while maintaining operational excellence, announcing expected plant closures and sales at our locations in Lincolnton, North Carolina; Zoetermeer, the Netherlands; Changzhou City, China; and Foshan, China.

In the year ahead, we will look to capitalize on our 2013 investments in information technology, supply chain and quality, shift capital allocation to new technologies and further improve our cost of goods by capturing purchasing synergies. We will also continue to optimize our global manufacturing and distribution network, with our refocused global business structure driving efficiencies across the organization and capitalizing on the most efficient utilization of human and financial resources."

"Actavis is in a strong position to deliver growth and continue generating strong cash flow to support the rapid pay-down of debt," said R. Todd Joyce, Actavis' Chief Financial Officer. "We exceeded expectations by ending the year below 2.8x Debt to Adjusted EBITDA, and expect to generate operating cash flow, assuming no major acquisitions, sufficient to further reduce leverage to 2.2x by the end of 2014."

Actavis estimates total net revenue for 2014 will be over $10.0 billion, including:

-Total Actavis Pharma segment revenue of approximately $8.7 billion.

-Total North American Generics revenue of between $3.9 billion and $4.0 billion.

-Total North American Specialty Brands revenue of between $2.4 billion and 2.5 billion.

-Total International revenue of between $2.2 billion and $2.3 billion.

-Total Actavis Pharma adjusted gross margin of between 63 percent and 66 percent.

-Total Actavis Pharma adjusted SG&A as a percent of revenue between 8.5 percent and 9.5 percent.

-Total Anda Distribution segment revenue of approximately $1.5 billion.

-Gross margin of 11 percent to 13 percent.

-SG&A as a percent of revenue between 8.5 percent to 9.5 percent.

-GAAP R&D is expected to be between $800 million and $850 million.

-GAAP SG&A is expected to be between $2 billion and $2.1 billion.

-Adjusted non-GAAP earnings for 2014 is expected to be between $12.60 and $13.10 per diluted share.

-Adjusted EBITDA for 2014 is expected to be between $3.15 billion and $3.25 billion.

-Non-GAAP tax rate is expected to be between 16.5 percent and 17.5 percent.

"With our newly unveiled commercial structure, steadfast commitment to investing in research and development (R&D), efficient global operations network and flexibility to pursue strategic business development opportunities, Actavis is positioned better than ever to continue delivering double-digit organic growth in 2014 and the years beyond," concluded Bisaro.

Actavis plc is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products.

More Information:

((Comments on this story may be sent to

For more stories covering the world of technology, please see HispanicBusiness' Tech Channel

Source: Health & Beauty Close - Up

Story Tools