On November 8, 2017 Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company focused on delivering innovative therapies to patients with kidney disease through the biology of hypoxia-inducible factor (HIF), reported financial results for the third quarter ended September 30, 2017 (Press release, Akebia, NOV 8, 2017, View Source [SID1234521785]).
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"Akebia continues to execute on our global Phase 3 program for vadadustat in collaboration with our partners," said John P. Butler, President and Chief Executive Officer of Akebia Therapeutics. "In the third quarter, we announced positive Phase 2 top-line results from our vadadustat study in Japanese patients with non-dialysis-dependent chronic kidney disease, and findings from the Phase 2 study in dialysis-dependent patients are expected by year end. In addition, our partner, Mitsubishi Tanabe Pharma Corporation, announced the initiation of Phase 3 clinical studies of vadadustat in Japan. Enrollment continues in the global clinical program with the potential launch of vadadustat in the United States, Europe and Japan anticipated in 2020. In addition, we look forward to initiating our TRILO2GY study later this year or early 2018."
Third Quarter 2017 and Recent Corporate Highlights
Announced positive top-line results from a Phase 2 study of vadadustat in Japanese patients with non-dialysis-dependent chronic kidney disease, which confirmed findings from previous studies of vadadustat;
After a positive consultation with the PMDA, partner Mitsubishi Tanabe Pharma Corporation (MTPC) announced the initiation of a Phase 3 development program of vadadustat in non-dialysis patients and patients receiving peritoneal dialysis in Japan;
Provided MTPC with an option to access data from Akebia’s global Phase 3 vadadustat program for payments to Akebia of up to $25 million; and
The Independent Data Monitoring Committee for Akebia’s global Phase 3 PRO2TECT and INNO2VATE programs held another meeting and recommended continuing the studies without modification.
Financial Results
Akebia reported a net loss of ($23.1) million, or ($0.49) per share, for the third quarter of 2017 as compared to a net loss for the third quarter of 2016 of ($36.3) million or ($0.96) per share.
Collaboration revenue was $41.3 million for the third quarter of 2017, which related to the Company’s agreements with Otsuka. Collaboration revenue in connection with Akebia’s agreement with MTPC is expected to commence in the fourth quarter of 2017.
Research and development expenses were $58.7 million for the third quarter of 2017 compared to $31.2 million for the third quarter of 2016. The increase is primarily attributable to external costs related to the global PRO2TECT and INNO2VATE Phase 3 programs, the Phase 2 studies in Japan, and activities related to the FO2RWARD and TRILO2GY programs. Research and development expenses were further increased by headcount and compensation-related costs.
General and administrative expenses were $6.7 million for the third quarter of 2017 compared to $4.9 million for the third quarter of 2016. The increase is primarily attributable to an increase in costs to support the Company’s research and development programs, including headcount and compensation-related costs and associated facility and patent-related costs.
Akebia ended the third quarter of 2017 with cash, cash equivalents and marketable securities of $329.7 million. The Company’s collaborators have committed up to $373.0 million or more in license and cost-share funding, which Akebia continues to receive on a quarterly prepaid basis. Akebia expects existing cash resources to fund the Company’s current operating plan into the second quarter of 2019. Thereafter, committed research and development funding will continue to be received from Otsuka on a prepaid, quarterly basis.