Company: Kite Pharma
Title: Chief Operating Officer
When Cynthia Butitta joined Kite Pharma in January 2014 as employee number 8 and its first chief financial officer, she was tasked with figuring out how to speed up development of the company’s CAR-T treatment, axicabtagene ciloleucel (axi-cel). Within four years, Kite raised more than $146 million in an initial public offering and completed additional financings totaling $1 billion. And under Butitta’s tutelage, Kite grew to 650 employees and built a 43,500-square foot plant near its Los Angeles headquarters.
The reward: An $11.9 billion buyout offer from Gilead in August 2017, followed shortly thereafter by the FDA approval of axi-cel, which is now called Yescarta, to treat some patients with lymphoma.
When asked what the secret is to her success, Butitta credits Kite’s founder, UCLA urology professor Arie Belldegrun, who called her out of the blue in 2013 after a New York banker recommended her to him. Butitta had been the CFO of NextWave Pharmaceuticals, which Pfizer acquired in 2012 for $700 million. She hadn’t intended to jump back into biotech operations, but she was drawn to the idea of developing a next-generation oncology treatment—and to Belldegrun, who promised her almost full autonomy to take the steps needed to get Yescarta approved quickly.
“I had never worked with someone I didn’t know, but he empowered me,” Butitta told FiercePharma. When Belldegrun asked her to help identify a CEO for the startup, she persuaded him to take the job instead, even though he had never managed a biotech company before. “Nobody had the passion for this or the knowledge of the science like he had,” she said. Once Belldegrun was at the helm, “I asked, ‘Should I check in with you first before I make a decision?’ He said, ‘Just go for it.’”
So she did. And one of her first big decisions was to do something that many biotech executives would consider way too risky: build a $40 million manufacturing plant before the science of the therapy that would be made there was fully validated.
“We had to take a leap of faith that the drug would work,” she said. In June 2016, less than 18 months after construction started, the plant opened, equipped to produce up to 5,000 CAR-T treatments per year.
Butitta’s financing strategy was equally unusual. She decided to anchor Kite’s IPO with a $50 million mezzanine round in April 2014 that was priced at a 10% discount to the public offering price of $17.
“I got a lot of grief for that,” she recalled. But the IPO in June of that year ended up being one of the best of 2014, as shares rose more than 200% by the end of the year. “Every financing after that was an up round,” Butitta said.
The road to FDA approval was far from easy, however. As impressive as Kite’s trial results were—the complete remission rate was 51% in the pivotal trial—the company faced questions along the way about safety, particularly when it revealed that one patient in its trials died of brain swelling, the very same side effect that sidelined Kite CAR-T rival Juno. Meanwhile, market leader Novartis sped ahead of Kite, winning the first FDA approval for a CAR-T treatment, Kymriah, to treat some leukemia patients, in August 2017.
Butitta and Belldegrun never lost faith in Yescarta, and that proved invaluable when it came time to entertain the offer from Gilead. Even though she was Kite’s second-largest shareholder, Butitta resisted the temptation of a large payday and advised the board to weigh what the best move for Kite’s other stakeholders would be.
“We had to evaluate whether we should take risks away by bringing on a pharma company that has deeper pockets,” she said. “The real key to making the decision was thinking about what would be in the best interest of patients. We liked Gilead—it has an entrepreneurial culture, like Kite’s. We felt like we were leaving the baby with good adoptive parents.” The deal closed in October 2017.
Butitta, who is retiring from Gilead at the end of 2017, could have parlayed her Kite accomplishments into a top management job at a Big Pharma company. But she decided to step away from operations for good this time, and use her experience in more of an advisory role instead. On Nov. 2, she joined the board of directors of UroGen, an Israeli company developing drugs to treat urologic cancers. The chairman of the company is her biggest fan, Belldegrun.