- AbbVie's newest drug Skyrizi earned $48 million in just two months on the market, spurring the biotech to boost its 2019 sales forecasts for the drug by two-thirds.
- The IL-23 inhibitor launched in May as a treatment for plaque psoriasis. AbbVie had previously estimated $150 million in annual sales along with "very modest" sales contributions during the second quarter. AbbVie executives said Friday the company now expects Skyrizi to reach $250 million in global sales for 2019.
- Cowen & Co.'s Steve Scala called the initial sales figures "one of the biggest launch numbers in my memory" on the Friday morning conference call. AbbVie's stock was up about 2% following the Friday morning call.
AbbVie's topseller Humira (adalimumab) posted $9.3 billion in sales for the first half of 2019, a 6% decrease from a year ago. While U.S. sales have kept growing by high single digits, the entry of biosimilar competition in Europe has put a significant dent in international revenue. U.S. competition is set to begin in 2023.
Skyrizi (risankizumab) and upadacitinib are critical parts of AbbVie's plan to grow beyond Humira.
On a conference call Friday, AbbVie CEO Rick Gonzalez highlighted Skyrizi's rapid uptake among both previously untreated patients and those switching from other drugs. The CEO noted that its market share among those patients is nearing that of Humira's before Skyrizi launched, and most of that prescription volume is coming from other biologic competitors, not Humira.
"We've only seen Humira trend down slightly from that," Gonzalez said. "So it's clear that Skyrizi is capturing significant competitive opportunities in the marketplace."
Some analysts have speculated that Skyrizi might trigger antitrust concerns related to AbbVie's $63 billion deal to acquire Allergan, announced a month ago. Allergan also has an IL-23 in clinical development, raising the question of whether the Federal Trade Commission would require AbbVie to sell off Skyrizi to complete the deal.
Such worries aren't just theoretical: the FTC required Bristol-Myers Squibb divest Celgene's Otezla (apremilast) as a condition of its deal to acquire the biotech.
Yet AbbVie's general counsel Laura Hamill said they do not envision having to divest Skyrizi, noting the two drugs target different indications.
On upadacitinib, the Food and Drug Administration is set to make a regulatory decision by Aug. 19 on use of the drug in rheumatoid arthritis.
Multiple analysts asked about the regulatory process for the JAK inhibitor, especially as the FDA added a black box warning Friday to Pfizer's Xeljanz (tofacitinib). Safety concerns have lingered around the class of drugs, but AbbVie reiterated its confidence in upadicitinib.
"We do not have any concerns about approvability," said Michael Severino, AbbVie's vice chairman and president.
Both Skyrizi and upadacitinib will have several readouts in follow-on indications over the next 12 to 18 months, company execs said Friday.
Despite a modest jump Friday, AbbVie shares are still down by more than 12% since the company announced the deal for Allergan. Gonzalez said he will be meeting with Allegan employees in the coming weeks, as the companies prepare for the deal to close in early 2020.