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Can AbbVie (ABBV) Protect Revenues After Humira Patent Loss?

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AbbVie’s (ABBV - Free Report) key blockbuster immunology medicine, Humira lost patent protection in the United States in 2023. In 2022, Humira accounted for around 37% of AbbVie’s sales.

In January, Amgen (AMGN - Free Report) announced the launch of the first Humira biosimilar in the United States called Amjevita. After Amgen, several other companies like Boehringer Ingelheim, Coherus BioSciences and Novartis (NVS - Free Report) also launched their own Humira biosimilars. Novartis, through its generic division, Sandoz, markets its Humira biosimilar under the trade name Hyrimoz. At present, eight biosimilar versions of Humira have already been launched in the United States, per settlements with AbbVie, which should significantly erode sales in the second half of 2023 and 2024.

Humira biosimilars were launched in the EU in October 2018 and have been eroding international sales from the branded drug since 2019.

Year to date, AbbVie’s shares have lost 9% against the industry’s 7.6% rise.

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Nonetheless, though AbbVie’s revenues are expected to decline in 2023 due to the rapid biosimilar erosion of Humira, the company expects to return to robust sales growth in 2025.

AbbVie has several new drugs in its portfolio with the potential to drive the top line and make up for lost Humira revenues. Newer products, Skyrizi and Rinvoq, are performing extremely well bolstered by approvals in new indications. AbbVie has launched Skyrizi and Rinvoq across Humira's major indications, plus a distinct new indication, atopic dermatitis.

Skyrizi and Rinvoq are contributing meaningfully to revenues, including $4.6 billion in combined sales in 2021, $7.7 billion in 2022 and $4.85 billion in the first half of 2023. With approvals for many new indications, sales of these drugs could be higher in future quarters, which should support top-line growth in the next few years. Skyrizi and Rinvoq are expected to collectively exceed the peak revenues achieved by Humira by 2027. AbbVie expects combined sales (risk-adjusted) of Skyrizi and Rinvoq to be more than $17.5 billion by 2025 and more than $21 billion by 2027. Meanwhile, new migraine drugs, Ubrelvy and Qulipta, represent a $1 billion-plus peak sales opportunity each.

Importantly, the erosion in Humira sales due to biosimilar launches in the first half of 2023 was less severe than expected as volumes held up better than expected. The company now expects the erosion in 2023 to be 35% versus 37% previously.

AbbVie has several early/mid-stage pipeline candidates that have blockbuster potential. AbbVie expects several regulatory submissions and key data readouts in 2023.

AbbVie has an exciting and diverse pipeline of promising new therapies in both blood cancers and solid tumors like navitoclax for myelofibrosis, ABBV-383, a BCMA CD3 bispecific, being studied (in phase I) for multiple myeloma and Teliso-V, a promising c-Met ADC being studied (in phase III) for nonsquamous non-small cell lung cancer. AbbVie and partner Genmab gained FDA’s accelerated approval for Epkinly/epcoritamab in patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL), in the United States in May 2023 while regulatory applications are under review in the EU. Phase III studies are ongoing on epcoritamab in earlier lines of DLBCL and for follicular lymphoma.

AbbVie’s acquisition of Allergan in 2020 significantly expanded and diversified its revenue base with new therapeutic areas, enhancing its long-term growth potential. The acquisition strengthened AbbVie’s existing leadership position in immunology and hematological oncology while providing additional growth franchises in aesthetics and neuroscience.

AbbVie’s rationale behind the Allergan deal was to add a new blockbuster product to its portfolio, Botox, ahead of generic competition for Humira. Approved for therapeutic and aesthetic use, Botox has now become a key top-line driver for AbbVie, with Humira sales expected to be extensively eroded in the United States in 2023 and 2024.

Zacks Rank

AbbVie currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

AbbVie Inc. Price and Consensus

AbbVie Inc. Price and Consensus

AbbVie Inc. price-consensus-chart | AbbVie Inc. Quote

A better-ranked large drug stock worth considering is J&J (JNJ - Free Report) , which has a Zacks Rank of 2 (Buy).

Estimates for J&J’s 2023 earnings per share have increased from $10.66 to $10.75 over the past 60 days. Estimates for 2024 have jumped from $11.01 per share to $11.30 in the same timeframe. J&J’s stock has declined 6.9% year to date.

J&J beat earnings expectations in all the trailing four quarters. The company delivered a four-quarter earnings surprise of 5.58%, on average.


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