How the Daiichi CEO capped a $37 billion recovery with a cancer drug deal

The future looked bleak for Japanese drugmaker Daiichi Sankyo Co. when George Nakayama took over as chief executive officer in 2010.

The stock was in the middle of a six-year free fall, its Indian subsidiary Ranbaxy Laboratories Ltd. was banned by the US from selling products there, and a new anti-clotting medicine was slapped with the strictest safety warning.

Nakayama, a former salesman for one of Japan’s biggest brewers, decided to reboot Daiichi Sankyo, pivoting away from generic medicines and toward the more lucrative business of cancer drugs. He sold scandal-ridden Ranbaxy for $3.2 billion, acquired two US-based makers of cancer medicines and focused research on a class of drugs that could replace chemotherapy.

Affirmation arrived in March, when British drugmaker AstraZeneca Plc agreed to pay as much as $6.9 billion to jointly develop one of those medicines, known as antibody drug conjugates, for patients of breast and other cancers. Under Nakayama’s turnaround plan, Daiichi Sankyo’s stock has rocketed 470% to an all-time high -- adding $37 billion in market value to make it Japan’s second-biggest drugmaker after Takeda Pharmaceutical Co.

“So many things happened, but I was extremely lucky,” Nakayama, 69, said during a July 12 interview. “Looking back, it was a pretty tough start. It got better over time.”

Soon after the deal, Nakayama ceded the CEO title to Sunao Manabe, a veterinarian by training, though Nakayama remains chairman. He’s leaving on a high note, with Daiichi Sankyo the best performer this year on an MSCI index of the biggest drugmakers. The stock was down 0.8% at 10 a.m. in Tokyo on Tuesday, while the benchmark Topix index slumped 2.4% amid a global market selloff.

Analysts say the future looks bright for the Tokyo-based company, formed in 2005 through the merger of Daiichi Pharmaceutical Co. and Sankyo Co. Revenue is expected to increase 14% through 2023, while operating profit is seen surging 78%, according to analysts surveyed by Bloomberg.

“The strategy shift is now starting to pay off,” said Yasuhiro Nakazawa, an analyst at SMBC Nikko Securities Inc. in Tokyo. “Daiichi Sankyo is really betting on the new direction as a whole.”

That blueprint is anchored by the cancer drug known as DS-8201, which the company plans to seek US approval for by Sept. 30. Daiwa Securities Co. analyst Kazuaki Hashiguchi predicts it will reach almost $8 billion in annual sales by 2030, surpassing Roche Holding AG’s breast-cancer drug Herceptin, which DS-8201 seeks to replace.

The drug’s potential as a blockbuster medicine comes as global pharmaceutical giants are scrambling to transform themselves to replace aging pipelines. Cancer has become one of the hottest areas for deal activity between drug and biotechnology companies, as scientific advances are leading to new tailored therapies with strong growth potential.

Daiichi Sankyo partnered with AstraZeneca to develop and commercialize DS-8201, and the two companies agreed to split profit and costs. Such ADCs are a class of drugs that can attack cancer cells in the body without damaging surrounding healthy ones. Analysts say DS-8201 could triple the number of patients who receive targeted treatment for breast cancer, which kills more than 500,000 women annually.

“This Daiichi Sankyo drug has the potential to transform cancer care, so it is a very important product for us and, of course, for our partner,” Pascal Soriot, CEO of AstraZeneca, said in a July 25 interview on Bloomberg Television.

Daiichi Sankyo is developing about a dozen cancer-fighting compounds, and considering further partnerships. It will devote a “significant portion” of its research budget toward successfully bringing them to the market, Manabe said in a July 9 interview. “Compared with a few years ago, our cancer pipeline is very rich now,” Manabe said.

This new focus represents a sea change for Daiichi Sankyo, which was saddled with headaches when Nakayama took over. His early priority was to save Ranbaxy’s operations. Two of the Indian company’s four plants faced US bans because of data fabrication, so Nakayama tried to strengthen the remaining two. His efforts fizzled, and they were banned by the US starting in 2013.

“We just couldn’t quite grasp the depth of Ranbaxy’s data falsification,” Nakayama said.

Daiichi Sankyo found a buyer in Indian rival Sun Pharmaceutical Industries Ltd. in 2014. But its problems weren’t over. Daiichi Sankyo paid a $39 million fine in 2015 to settle US allegations it gave kickbacks to doctors in exchange for prescribing company medicines. Most of the alleged infractions occurred before Nakayama’s tenure. That same year, its blood thinner edoxaban received US approval but carried a “boxed warning” about use by certain patients, limiting its market potential.

Shifting Focus

Nakayama decided the company needed a change, so he sold the Sun Pharmaceutical stake and shifted his focus to cancer drugs, overhauling operations, making acquisitions and hiring Antoine Yver, who ran the oncology unit at AstraZeneca, in April 2016.

Daiichi Sankyo previously spent more than $1 billion to gain cancer medicines through takeovers of Plexxikon Inc. in 2011 and Ambit Biosciences Corp. in 2014, and its ADCs were showing promise in early testing.

“The global oncology market became subdivided and not a single winner could take it all,” Nakayama said. “If we had the world-class science and acted fast, we had a chance.”

The former CEO also takes a humble view of the company’s turnaround, giving some credit to fortune: in finding a buyer for Ranbaxy, having labs produce new compounds at the right time, latching onto AstraZeneca’s Yver to run the cancer business.

“God made the timing well,” Nakayama said.