Takeda Pharmaceutical Co. Ltd. beat competitors to secure the most innovative drug approvals in China last year, despite being a relative latecomer to the market.
Unlike some other overseas drugmakers, including U.K.-based AstraZeneca PLC, which have already made China one of their top markets, Takeda only began releasing drugs in the country with the launch of cancer therapy Ninlaro in 2018. But since then, the Tokyo-based company has ramped up its expansion.
In 2020 alone, Takeda gained four approvals from China's National Medical Products Administration — Entyvio, Adcetris, Replagal and Takhzyro — for treating diseases ranging from cancer to the genetic disorder Fabry disease, according to the company's financial report for the quarter ended Dec. 31, 2020. Entyvio was also included in China's drug reimbursement list in 2020, which enables reimbursement by the country's national medical insurance scheme.
These launches take Takeda one step closer to its target of winning more than 15 Chinese approvals by March 2025 and also align with the company's other goal of increasing its focus on innovative drugs in the country, after it agreed to sell a portfolio of noncore prescription therapies in China to Hasten Biopharmaceutic Co. Ltd. in December.
In the future, Takeda executives said they will aim for speedier approvals in the world's second-largest pharmaceutical market.
"Today a lot of what we do in China is playing catch up, but our intention is to register our [innovative] drugs in the U.S., Europe, Japan and China at the same time," Andrew Plump, Takeda's president of research and development, said in a Feb. 4 earnings conference call.
Two drugs the company is hoping will win Chinese approval by March 2021 are Vpriv, a treatment for a rare inherited metabolic disorder called Gaucher disease, and cancer drug Alunbrig.
The expansion in China is part of Takeda's effort to drive growth by new drug releases alongside research and development. "We are starting to see momentum in our pipeline and progress," President and CEO Christophe Weber said in the call.
"How have we been doing so far in a very challenging year given the pandemic? I would say that our progress has been quite strong, in fact better than I would have expected," Plump said.
Outside of China, TAK-721, a treatment for eosinophilic esophagitis, an allergic inflammatory condition of the esophagus, was granted priority review by the U.S. Food and Drug Administration in December. The company also plans to submit a marketing application for its dengue vaccine TAK-003 by March 2021.
Reducing debt
As well as progress advancing its pipeline, Takeda also brought down its net debt to adjusted EBITDA ratio to 3.6x in December 2020, from 3.8x in April, through the sale of its noncore assets in China along with other divestitures.
So far, the proceeds Takeda generated from asset sales have totaled $11.6 billion, exceeding the $10 billion goal it previously set to lower its debt after the acquisition of Shire PLC.
"We are really impressed to see our progress on deleveraging and debt reduction. We remain committed to our capital allocation policy — that is deleveraging rapidly, invest in our growth business, in particular, investing in China for growth," said CFO Costa Saroukos.
"We're investing in our pipeline in R&D, and we're investing in PDT, our plasma business," Saroukos added.
Takeda's net profit attributable to owners of the company surged 320.8% year over year to ¥178.9 billion for the nine months ended Dec. 31, 2020. Revenue dropped 3.6% during the nine months to about ¥2.43 trillion compared to the year-ago period.
As of Feb. 3, US$1 was equivalent to ¥105.06.
