In his first earnings call with Gilead Sciences Inc., CEO Daniel O'Day noted that strengthening the company's drug pipeline was one of his top priorities.
O'Day, who took over as CEO in March, said that his immediate priorities also include ensuring optimal commercial delivery for current and prelaunch stage medicines, as well as bolstering organizational strength to make sure Gilead has "the right people in the right roles."
Cell therapy a 'critical element' of long-term strategy
The CEO stated on the company's first-quarter earnings call that he is looking at both internal programs and corporate development opportunities in order to boost the company's pipeline.
O'Day deemed the identification of requirements for short- and long-term success in cell therapy as one area of "pressing need."
This resulted in deciding to make Kite, which Gilead acquired in October 2017, a separate business unit. The decision was announced internally at the end of March.
O'Day said the company has started a search for a CEO of Kite, who will report to him and will have full accountability for all aspects of cell therapy. "I believe that providing Kite with this degree of autonomy will foster agility, innovation and entrepreneurialism," he added.
"Cell therapy is a critical piece of the puzzle with regards to the long-term future of oncology and a critical element of Gilead's long-term strategy, helping us to build on a legacy of transformational medicines," the CEO stated.
Gilead plans to release top-line results of its registration trial of chimeric antigen receptor T-cell, or CAR-T cell, therapy KTE-X19 in patients with relapsed or refractory cell lymphoma, said John McHutchison, the company's head of research and development.
Lymphoma is a type of cancer that begins in lymphocytes, the infection-fighting cells of the immune system.
Gilead expects to seek the U.S. regulatory approval for KTE-X19 by the end of 2019 if the results from the trial are positive.
KTE-X19 was granted a breakthrough therapy designation by the U.S. Food and Drug Administration, so an application for the treatment would be considered for expedited review by the regulator.
Progress on rheumatoid arthritis, HIV drugs
In March, Gilead said that two late-stage studies — FINCH 1 and FINCH 3 Phase III — involving filgotinib met their main goal of improving symptoms of rheumatoid arthritis patients. Based on results from the three Finch trials, the company plans to seek regulatory approvals in Europe for filgotinib as a treatment for rheumatoid arthritis in the second half of 2019.
The Foster City, Calif.-based biopharmaceutical giant has also initiated a process to engage with the FDA as it seeks the drug's approval in the U.S.
Additionally, Gilead is seeking expanded use of its medicine Descovy in the U.S. to reduce the risk of sexually acquired HIV-1 infection among people who are HIV-negative and at risk of the disease. The company has filed an application with the FDA for this use of Descovy and expects approval in the fourth quarter.
M&A plans
O'Day noted that the company continues to seek opportunities that supplement its portfolio through M&A or partnerships, noting that the company's M&A activity is "led by science at the end of the day."
The CEO said that he believes adding to the company's portfolio via M&A or partnerships is in the best interest of shareholders in the company.
O'Day added that bolt-on type acquisitions have the "highest likelihood" but noted that the company is also looking at early to mid-stage as well as late-stage opportunities.