Teva banks on blockbuster Austedo sales as COVID-19, Copaxone generics take their toll

Facing generic pricing pressure and Copaxone copycats, Teva Pharmaceutical has a lot riding on tardive dyskinesia (TD) drug Austedo and migraine med Ajovy. Hamstrung by the pandemic, Austedo came just shy of Teva’s 2021 sales projection. Still, 2022 could be the year the drug breaks the blockbuster barrier, executives said on a call with analysts Wednesday.

Austedo ginned up $282 million in fourth-quarter sales, climbing 52% over the $185 million it snagged for the same period in 2020. That contributed to a full-year haul of $802 million, or a 26% sales increase year-over-year. Teva had previously forecast 2021 Austedo sales of $850 million.

For 2022, Teva expects the drug to reap roughly $1 billion in sales, CFO Eli Kaliff said on the company's earnings call.

Austedo's U.S. momentum is picking up, the company says. Teva recorded more than 42,000 Austedo prescriptions in the last three months of 2021, versus 35,000 during the same period in 2020.

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Austedo’s potential in TD, meanwhile, remains largely untapped, Teva executives argue. Tardive dyskinesia affects around 500,000 people in the U.S. Fewer than 15% of those people are diagnosed and fewer than 6% receive treatment, Teva estimates. Teva is continuing efforts to expand access and availability of the drug, and its efforts include a direct-to-consumer component, CEO Kåre Schultz noted on the call.

“We think Austedo will keep on growing nicely” throughout the decade, Schultz added. The company estimates the drug’s sales will grow by about $200 million in 2022, and Schultz said he doesn’t “see any reason why that absolute growth should slow down over the coming years.”

Migraine prevention med Ajovy, for its part, reached 28% market share in Europe and 21% in the U.S. last year. For all of 2021, Ajovy made $313 million worldwide, with $176 million of that coming from North America.

Teva’s total 2021 sales clocked in at $15.9 billion, down about 6% versus the previous year. Revenues for the fourth quarter were $4.1 billion, an 8% decline from the $4.45 billion Teva made during the last three months of 2020. Teva blamed those less-than-stellar figures in part on lagging sales of its multiple sclerosis med Copaxone, plus generics pressures in the U.S. and Japan. Patients making fewer trips to their doctors during the COVID-19 pandemic also weighed on prescribing patterns, Teva noted.

Looking ahead, Teva expects to generate revenues between $15.6 billion and $16.2 billion in 2022. Austedo’s blockbuster forecast aside, Teva expects Copaxone to ring in about $850 million—compared with about $1 billion in 2021 sales—while Ajovy is expected to pull in some $400 million this year.

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As for upcoming launches, Teva is awaiting an FDA decision on a long-acting injectable version of risperidone for patients with Schizophrenia. The regulator is expected to reach a verdict in the first half of 2022. Meanwhile, Teva has its commercial organization and salesforce in place ahead of the potential launch, Sven Dethlefs, executive vice president of North American commercial, said on the call.

Separately, Teva regularly updates on the status of its ongoing opioid litigation during its analyst calls.

Aside from individual settlements with Texas and Louisiana, Teva notched a recent win in California, and it’s feeling emboldened by a Johnson & Johnson victory in the Oklahoma Supreme Court. As for the New York lawsuit where Teva was last year found liable for contributing to the state’s opioid epidemic, mistrial and other post-trial motions are planned for the first and second quarter of 2022, followed by a potential appeal later this year, CEO Schultz said.

Teva’s “very happy” with its Texas settlement, Schultz added. The CEO reiterated his confidence that Teva can reach a nationwide settlement within the next 12 months, with the Texas deal providing “a good starting point for those ongoing discussions.”