Looking to 2019, AbbVie says US sales of its bestseller monoclonal antibody Humira (adalimumab) will continue to grow but expects a $2 billion hit from biosimilar competition.

For the full year 2018, AbbVie reported total sales of $32.8 billion (€28.7 billion), comprising $19.9 billion in sales of the world’s most successful drug by revenue, Humira (adalimumab). This represented a 7.4% year-on-year growth for the monoclonal antibody (MAb).

But for AbbVie, 2018 was tainted by the approval and launch of several adalimumab biosimilars in Europe and other key markets – including products from Sandoz, Amgen and Samsung Bioepis. Therefore, for the next 12 months, AbbVie has forecasted a drop in international revenue.

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“The event that has for many years concerned investors most has been the loss of exclusivity for Humira… We have long been planning and preparing for the event that is now upon us,” Rick Gonzalez, AbbVie’s CEO, said in a conference call.

“We are now facing direct biosimilar competition in Europe and other countries, which represent approximately 75% of our international Humira business or approximately 25% of total global Humira revenues.”

As a result, AbbVie will absorb roughly $2 billion in sales erosion in 2019, he added.

However, in the US – where 2018 Humira sales grew 10.7% over the year prior – sales are expected to continue to grow in 2019. Direct competition is not expected to begin until 2023 in the US market, following settlements between AbbVie and biosimilar developers, somewhat offsetting the decline.

“Our guidance around Humira for 2019 is in the US strong growth,” said Bill Chase, EVP of Finance and Administration. “7% is what we are recommending to model. Outside of the US, obviously with the advent of biosimilars, we are forecasting a decline, and currently we view that as about 30% on an operational basis.”

If accurate, overall sales in 2019 will stand around $19 billion, representing the first ever drop in Humira’s annual revenue.

M&A

AbbVie’s management also spoke on its acquisition strategy, with Gonzalez saying that the firm will continue to be active and look at opportunities available, though unlikely to make a large deal.

“We look at things that are small, things that are medium, things that are large, and we certainly have the wherewithal to be able to do things, if we could find something that strategically fit and we could get a good return on that, I can tell you we would act and we would act swiftly in order to do that,” he said.

“We fundamentally have a pipeline that we believe has the ability to do what we strategically intended it to do, and that is to absorb the impact of biosimilars. Our focus is to ramp that pipeline as rapidly as we possibly can and make sure we’re in a position to be able to continue to drive strong growth in the business.”

In 2015, the firm acquired Pharmacyclics for around $21 billion, adding hematology drug Imbruvica (ibrutinib) to its pipeline.

“That’s what I view as a — the size of roughly a large bolt-on kinds of transaction. And when I say a large deal, I’m thinking about a very significant kind of deal, merger type deals; we’re not contemplating anything of that magnitude at all.”