Teva Pharmaceutical Industries Ltd. provided an outlook for its financial performance for the year ending December 31, 2015. Two key issues for the company in 2015 will be decreased revenues for its top-selling drug, Copaxone (glatiramer acetate), a drug to treat relapsing-remitting multiple sclerosis (MS) due to increased generic competition and overall competition in the MS market, and declining US revenues for a generic version of the respiratory drug, Pulmicort (budesonide).  

Overall, in 2015, Teva anticipates revenues of $19 billion to $19.4 billion with operating income of between $5.7 billion and $5.9 billion. Generics are expected to account for the largest share of the company’s revenues in 2015 with anticipated revenues of between $9.1 billion and $9.5 billion. The company anticipates revenues in its specialty products business for 2015 of between $7.9 billion and $8.3 billion.

“Generics remain at the heart of our business, both as the cornerstone of the company, but also as an area that has great impact on society,” said Erez Vigodman, president & CEO of Teva,” in a company statement. “At the same time, we anticipate four specialty product approvals and five submissions in 2015, which we believe will improve treatment options for patients and add value for all of our stakeholders. As we look to the future, we will continue to deliver on our operational, financial, and strategic goals to further explore the unique space Teva has at the intersection between generics and specialty and increase access to healthcare to patients around the world.”

In its specialty products business, a key issue for Teva in 2015 is rising generic-drug competition for Copaxone, Teva’s top-selling drug in 2013 with revenues of $4.328 billion. Copaxone 20 mg/mL is expected to face two AB-rated generic competitors in the US, beginning in September 2015; earlier entry by generics could reduce operating income by $30 million to $50 million per month, according to Teva. The US Orange Book patents covering Copaxone (20 mg) expired in May 2014. To combat generic-drug incursion for Copaxone, Teva developed a new formulation, Copaxone 40 mg/mL, which is administered three times a week. The new formulation, which was approved by the US Food and Drug Administration in January 2014, allows for a less frequent dosing regimen administered subcutaneously for patients with relapsing forms of MS. The company expects continued adoption of Copaxone 40 mg/mL in the US in 2015. Copaxone 40 mg/mL will be launched in the European Union and additional countries outside Europe commencing in the first quarter of 2015. Overall, Teva expects revenues of between $3.5 billion to $3.7 billion for Copaxone due to increased generic-drug competition as well as increased competition in the MS drug market overall.

In its generic business, Teva will also face additional generic competition for its generic version of the respiratory drug, Pulmicort (budesonide), in the first half of 2015 in the United States, resulting in a decrease of revenues by $400 million to $500 million and a decrease in operating profit of $100 million to $200 million, compared to 2014.

The company expects to spend approximately $1 billion to $1.2 billion on share buybacks during 2015. As a result, the number of outstanding shares is expected to be between 850 million and 860 million.

Source: Teva Pharmaceutical Industries