AbbVie warns of bigger hit to Humira sales this year as biosimilar competition dents Q4 results

Headline results for the fourth quarter:

Note: All changes are versus the prior-year period unless otherwise stated

What the company said:

"We're entering an important new phase," remarked CEO Richard Gonzalez, adding that the near-term launches of "four major products that have multibillion-dollar potential" are expected to offset and absorb the impact of biosimilar competition on Humira sales. However, Gonzalez indicated that merger-type deals are not on the company's radar, despite some analysts suggesting a bid could be made for Bristol-Myers Squibb. "As far as the appetite for a big deal, I can tell you that is not something that we are contemplating," Gonzalez commented.

AbbVie noted that the fourth-quarter loss was due to a $4.1-billion impairment charge related to intangible assets acquired as part of the acquisition of Stemcentrx in 2016 for $5.8 billion. AbbVie announced in December last year that it would halt enrolment in a Phase III study assessing rovalpituzumab tesirine, also known as Rova-T, as a second-line treatment for patients with advanced small-cell lung cancer. An interim analysis showed that the drug, which the company gained via the purchase of Stemcentrx, was associated with shorter overall survival than in the topotecan arm. 

Other results:

• Humira: $4.9 billion, up 0.5 percent, but below forecasts of $5 billion. Sales of the product rose 9.1 percent in the US to $3.6 billion, but slipped 17.5 percent in other markets to $1.3 billion "due to direct biosimilar competition" in Europe.
• Haematologic oncology products: $1.1 billion, up 50.2 percent
  • Imbruvica: $1 billion, up 42 percent, in line with estimates
  • Venclexta: $124 million
• Hepatitis C product sales: $862 million, up 69.3 percent, above forecasts of $801 million
  • Mavyret: $819 million
• Full-year revenue: $32.7 billion, up 16 percent
• Full-year profit: $5.7 billion, versus $5.3 billion

What analysts said:

"When they first started talking about outside US biosimilar competition it was that it would be in the mid-teens over a two-year period," commented Piper Jaffray & Co analyst Christopher Raymond, adding "it's a concern that if they got it wrong once, how do we know that the current guidance is accurate?"

Looking ahead:

AbbVie expects earnings per share in 2019 of between $8.65 and $8.75, which it noted represents growth of 10 percent at the midpoint of the range. Analysts forecast earnings of $8.74 per share.

The company also warned that sales of Humira in international markets will fall more than previously expected this year, with the drugmaker's shares dropping as much as 7.5 percent on the news. William Chase, chief administrative officer, said sales of the product will decline by about 30 percent on an operational basis in markets outside the US, higher than an earlier estimate of around 26 percent to 27 percent.

"What we're giving you is our best estimate of what will happen," said Gonzalez, continuing "obviously, this is driven by not us, it's driven by competitors and their behaviour and so ultimately it's not like we have a crystal ball that we can predict exactly what they do." According to AbbVie, it expects to lose almost $2.5 billion in Humira sales this year, although Gonzalez said that despite this, "the underlying business…is growing at 6 percent or 7 percent from an [earnings per share] standpoint." Gonzalez added "if you adjusted for the $2.5 billion, the bottom-lines growing at 23 percent. There aren't many businesses around here that have that kind of performance."

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