akba-ex99

- Initiated INNO₂VATE Phase 3 Program for Vadadustat in Dialysis-Dependent Patients

CAMBRIDGE, MA, August 8, 2016 -- 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), today announced financial results for the second quarter ended June 30, 2016.

“We continue to make progress with our critical development and strategic priorities. With the initiation of INNO₂VATE and the continued enrollment in our PRO₂TECT program for non-dialysis patients, we now have two indications in Phase 3 for anemia related to chronic kidney disease,” said John P. Butler, President and Chief Executive Officer of Akebia. “In addition, our efforts to a secure a collaboration for vadadustat in Europe and other international regions continues to progress with the goal of financing our global Phase 3 program and supporting a strong commercial introduction.”

The Company reported a net loss of ($35.8) million, or ($0.95) per share, for the second quarter of 2016. Net loss for the second quarter of 2015 was ($10.7) million or ($0.40) per share.

The Company did not record any revenue for the second quarter of 2016 in connection with its Collaboration Agreement with Mitsubishi Tanabe Pharma Corporation. Revenue recognition is expected to begin in 2017 when the scope of the Phase 3 program is agreed upon with Japanese regulatory authorities and when all revenue recognition criteria have been satisfied. Accordingly, as of June 30, 2016 the Company had $40.0 million of deferred revenue.

Research and development expenses were $30.9 million for the second quarter of 2016, compared to $6.5 million for the second quarter of 2015. The increase is primarily attributable to external costs related to the PRO₂TECT Phase 3 program. Research and development expenses were further increased due to additional headcount and compensation-related costs.

General and administrative expenses were $5.3 million for the second quarter of 2016, compared to $4.4 million for the second quarter of 2015. The increase is primarily due to an increase in headcount and compensation-related costs of $0.5 million, and an increase of $0.5 million in commercial planning costs.

The Company’s cash used in operations during the second quarter of 2016 was $26.9 million, an increase of $14.8 million from $12.1 million used in operations for the same period of 2015. The Company ended the second quarter of 2016 with cash, cash equivalents and available securities of $188.6 million, and continues to expect cash resources to fund the current operating plan through the second quarter of 2017.

About Akebia Therapeutics
Akebia Therapeutics, Inc. is a biopharmaceutical company headquartered in Cambridge, Massachusetts, focused on delivering innovative therapies to patients with kidney disease through hypoxia-inducible factor biology. Akebia’s lead product candidate, vadadustat, is an oral therapy in development for the treatment of anemia related to chronic kidney disease in both non-dialysis and dialysis patients. Akebia has commenced its vadadustat Phase 3 program, which includes the PRO₂TECT studies for non-dialysis patients with anemia secondary to chronic kidney disease and INNO₂VATE studies for dialysis dependent patients. For more information, please visit our website at www.akebia.com.

Forward-Looking Statements

This press release includes forward-looking statements. Such forward-looking statements include those about Akebia's strategy, future plans and prospects, including statements regarding the potential indications and benefits of vadadustat, the timing of the INNO₂VATE and PRO₂TECT Phase 3 programs, and the progress toward securing a collaboration in Europe. The words “anticipate,” “appear,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement, including the risk that existing preclinical and clinical data may not be predictive of the results of ongoing or later clinical trials; the ability of Akebia to successfully complete the clinical development of vadadustat; the funding required to develop Akebia's product candidates and operate the company, and the actual expenses associated therewith; the cost of the Phase 3 studies of vadadustat and the availability of financing to cover such costs; the timing and content of decisions made by the FDA and other regulatory authorities; the rate of enrollment in clinical studies of vadadustat; the actual time it takes to initiate and complete clinical studies; the success of competitors in developing product candidates for diseases for which Akebia is currently developing its product candidates; Akebia’s ability to negotiate commercially reasonable terms with a European collaboration partner, including economics sufficient to fund the global Phase 3 program; and Akebia's ability to obtain, maintain and enforce patent and other intellectual property protection for vadadustat. Other risks and uncertainties include those identified under the heading “Risk Factors” in Akebia's Annual Report on Form 10-Q for the quarter ended June 30, 2016, and other filings that Akebia may make with the Securities and Exchange Commission in the future. Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release.

Akebia Contact
AJ Gosselin
Manager, Corporate Communications
617-844-6130
agosselin@akebia.com

	Three Months Ended						Six Months Ended
	June 30, 2016			June 30, 2015			June 30, 2016			June 30, 2015
Operating expenses:
Research and development	$	30,877		$	6,505		$	51,112		$	13,168
General and administrative		5,311			4,384			11,122			8,617
Total operating expenses		36,188			10,889			62,234			21,785
Operating loss		(36,188	)		(10,889	)		(62,234	)		(21,785	)
Other income, net		409			200			657			401
Net loss	$	(35,779	)	$	(10,689	)	$	(61,577	)	$	(21,384	)
Net loss per share applicable to common stockholders—basic and diluted	$	(0.95	)	$	(0.40	)	$	(1.65	)	$	(0.92	)
Weighted-average number of common shares used in net loss per share applicable to common stockholders—basic and diluted		37,811,056			26,614,671			37,342,324			23,340,590

	June 30, 2016		December 31, 2015
Cash, cash equivalents and available for sale securities	$	188,649	$	138,454
Working capital		171,590		129,149
Total assets		195,635		142,940
Total stockholders’ equity		133,288		130,998