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AstraZeneca Expects Revenue Boost with EU Approval of Three Key Medicines
AstraZeneca is gearing up for a significant expansion in the European Union (EU) market, as the company anticipates the approval of three of its medicines: Tezspire, Ultomiris, and Enhertu. This development comes following a recommendation from the European Medicines Agency (EMA) for these drugs.
The European Commission (EC) is now awaited to give its ruling within 67 days of the EMA's findings. If approved, these medicines will mark a significant step forward in AstraZeneca's growth strategy, as they are expected to boost the company's revenue and stock performance.
Enhertu, a drug being investigated for various cancers including colorectal and lung cancer, brought in $75 million in gross profits from sales during Q1 of 2021. It is already approved in several global markets for HER2-positive breast cancer. The addition of the EU market is expected to increase sales for Tezspire, although the exact peak sales are uncertain.
Tezspire, a biologic therapy for severe asthma that's still problematic after treatment with corticosteroids in addition to another drug, was already approved in the U.S. late last year. However, it made only $3 million in gross profit for the company in the first quarter due to shared profits with its development partner, Amgen. The commercialization efforts for these three medicines are likely to begin soon after the EC's approval.
Ultomiris, intended to be an adjunct treatment for certain subsets of patients with generalized myasthenia gravis (gMG), could soon become the only long-acting drug on the EU market for gMG patients, potentially capturing a large market share.
AstraZeneca's ongoing growth in alliance revenues and strong demand for these medicines in other regions suggest a positive impact on the company's financial performance. The company's 2025 Q2 results showed alliance revenues up 35% to $654 million, driven largely by partnered medicines including Enhertu and Tezspire.
While precise EU revenue figures from these pending authorizations are not detailed in the documents, the successful marketing approvals would enable AstraZeneca to begin direct or alliance-based sales in the EU—a significant pharmaceutical market—potentially boosting revenues further. Enhertu already shows strong uptake in China due to rapid hospital formulary listings, which can be viewed as a precedent for expected positive uptake in Europe as well.
With at least 183 programs in its pipeline and 16 of them in late-stage development, AstraZeneca is likely to continue being a strong competitor within the biopharma sector for years to come. The upcoming marketing authorizations of Tezspire, Ultomiris, and Enhertu in the EU are likely to have a positive impact on AstraZeneca's revenue and stock performance, supporting the company's growth prospects and market expansion.
As of now, AstraZeneca's trailing 12-month revenue is nearly $41.5 billion. The potential approval of these three drugs in the EU market is expected to contribute positively to this figure.
- AstraZeneca's revenue might experience a boost with the EU approval of Tezspire, Ultomiris, and Enhertu, as these medicines are anticipated to enhance the company's growth strategy, primarily in the business sector.
- Investing in AstraZeneca could potentially yield positive returns, given the positive impact the company's upcoming EU approvals might have on its financial performance and stock price.
- Health-and-wellness and medical-conditions sectors might see significant changes with the introduction of new medicines like Tezspire, Ultomiris, and Enhertu, especially in the treatment of conditions such as asthma, cancer, and generalized myasthenia gravis.
- The finance sector, in light of AstraZeneca's anticipated growth due to the EU market expansion, might witness increased investments as businesses seek to capitalize on the potential profits stemming from the company's pending drug approvals.
