Takeda Slashes Full-Year Net Profit Forecast by 71% Amid Clinical Setbacks and Market Challenges

Oct 31, 2023 12:03 CST Updated 12:03

Takeda

Biopharmaceutical Manufacturer

Last week, Takeda Pharmaceutical Company Limited announced its financial results for the first half of the fiscal year 2023. The report showed that a series of uncontrollable factors led to an increase in the company's net loss, and the full-year net profit forecast was cut by as much as 71%.

Specific data shows that Takeda Pharmaceutical Company Limited has revised its net profit forecast for 2023 from the original 142 billion yen to just 93 billion yen, equivalent to approximately $9.45 billion to $6.18 billion. Additionally, the operating profit forecast for the fiscal year from April 2023 to March 2024 has been adjusted downward from the original $2.3 billion to $1.5 billion. The operating profit for the first half of this year decreased by 53% compared to the same period last year. This news shocked investors and analysts, raising concerns about Takeda's future prospects.

Two Key Drugs Fail in Clinical Trials

The most prominent issue Takeda faces is the clinical failure of two key drugs.

Alofisel, an expanded allogeneic (or donor-derived) adipose mesenchymal stem cell (eASC) suspension, is used to treat complex perianal fistulas in adult patients with non-active or mildly active luminal Crohn's disease (CD). This is the first allogeneic stem cell therapy to receive centralized marketing authorization in the European Union and the first expanded human allogeneic adipose mesenchymal stem cell therapy approved in Japan.

However, on October 17, Takeda Pharmaceutical Company Limited announced that the Phase 3 ADMIRE-CD II study evaluating the efficacy and safety of Alofisel for the treatment of complex perianal fistulas in Crohn's disease (CPF) did not meet the primary endpoint of clinical remission at week 24. The safety profile of darvadstrocel was consistent with previous studies, with no new safety signals identified.

This is Takeda's second Crohn's disease failure in the past six months. In May this year, Takeda ended its 2018 collaboration with French biotechnology company Enterome SA to develop the small molecule drug sibofimloc for the treatment of Crohn's disease.

Another drug, Exkivity, also had a negative impact on Takeda's financial situation.

Exkivity is an oral therapy used to treat non-small cell lung cancer with EGFR exon 20 insertion mutations. It received accelerated approval from the FDA for marketing in 2021. However, in July this year, Takeda announced the termination of a Phase III clinical trial evaluating Exkivity as a first-line treatment for non-small cell lung cancer with EGFR exon 20 insertion mutations due to lack of efficacy.

The study was terminated because it failed to meet the primary endpoint, did not fulfill the confirmatory data requirements for FDA’s accelerated approval, and did not meet the requirements for conditional marketing approvals granted by other countries. Takeda had to initiate a global voluntary withdrawal, which brought a serious negative impact on the company's financial condition.

In fact, Takeda Pharmaceutical Company Limited also has another product — the dengue vaccine Qdenga — which has experienced a fate similar to that of Alofisel. Although this vaccine has been approved in Europe and other countries, in July this year, Takeda decided to voluntarily withdraw its application in the United States. This decision was made after discussions with the FDA regarding the collection of additional data.

In addition to the clinical drug failures, Takeda was also impacted by factors such as exchange rate fluctuations and taxation. These factors further exacerbated the company's financial difficulties, leading to a significant reduction in net profit.

Summary

Despite significant challenges, Takeda Pharmaceutical Company Limited remains hopeful for future growth. Takeda is relying on the drug Entyvio, a biologic used to treat ulcerative colitis, to drive performance growth. This drug has received FDA approval and plans are in place to expand its indications to include Crohn's disease. Additionally, the drug is expected to enter Phase III trials for psoriasis and psoriatic arthritis in 2023 and 2024, presenting new growth opportunities for Takeda.

Takeda Pharmaceutical Company Limited's CEO Christophe Weber assured investors in a recent conference call that he expects the company to return to growth in 2024 or 2025.

References:

1.https://mp.weixin.qq.com/s/JLOku21XqKe2pPOSWefnZQ

Recommended Articles of the Week

Reprint please contact BioValley and indicate the source clearly.

﹀

头.png

尾2.png