AKEBIA THERAPEUTICS, INC. (NASDAQ:AKBA) Files An 8-K Entry into a Material Definitive Agreement

Item1.01

On April25, 2017, Akebia Therapeutics, Inc. (Akebia) entered into
a Collaboration and License Agreement (the Agreement) with Otsuka
Pharmaceutical Co. Ltd. (Otsuka), to which Akebia granted Otsuka
an exclusive license for the development and commercialization of
vadadustat, Akebias oral hypoxia-inducible factor (HIF)
stabilizer currently in development for the treatment of anemia
related to chronic kidney disease. The territory covered by the
Agreement includes the European Union, Russia, China, Australia,
Canada, the Middle East and certain other countries (the
Territory), but excludes Latin America and other previously
licensed countries. Under the Agreement, Otsuka will be
responsible for certain development activities and
commercializing vadadustat in the Territory, while Akebia will
continue to lead the ongoing global Phase 3 development program.
Otsuka will fund a significant percentage of the costs of such
global development program regardless of the total actual costs
ultimately incurred. This Agreement follows a previously
announced collaboration between Akebia and Otsuka dated
December18, 2016 (the Prior Agreement) in which the parties
equally share the costs of developing and commercializing
vadadustat, as well as potential future sales of vadadustat, in
the United States.

Financial Terms

Under the terms of the Agreement, Akebia expects Otsuka to pay
Akebia at least $208 million, comprised of $73 million upon
execution of the Agreement and at least $135 million of
development funding. In addition, Akebia is eligible to receive
from Otsuka up to an aggregate of $657 million in development and
commercial milestones. Otsuka also agreed to make tiered,
escalating royalty payments ranging from low double digits up to
thirty percent of net sales of vadadustat within the Territory.
In limited circumstances, upper tier royalties may be subject to
reduction if the supply price charged by Akebia to Otsuka for
vadadustat exceeds certain agreed upon thresholds. Otsuka may
elect to conduct additional studies of vadadustat in the European
Union, subject to Akebias right to delay such studies based on
its objectives outside the Territory. Otsuka will pay a
percentage of the costs of any such studies, and Akebia will pay
its portion of the costs in the form of a credit against future
amounts due to Akebia under the Agreement.

Governance

The collaboration will be governed by joint committees and
operational teams, leveraging the governance structure
established in the Prior Agreement. Akebia will retain final
decision making authority with respect to the manufacture and
supply of vadadustat in the Territory, the global Phase 3
development program, and the global brand strategy for
vadadustat. Otsuka will have final decision making authority with
respect to certain Territory-specific development activities and
commercialization matters in the Territory.

Term and Termination

Unless earlier terminated, the Agreement will expire upon the
expiration of the royalty term in the last country in the
Territory. The royalty term ends upon the later of the expiration
of the patents licensed under the Agreement, the expiration of
data or regulatory exclusivity for vadadustat, or 10 years from
first commercial sale of vadadustat. Otsuka may terminate the
Agreement for a certain sub-territory or in its entirety upon 12
months prior written notice after the release of the first
topline data in the vadadustat global Phase 3 program. Either
party may, subject to a cure period, terminate the Agreement in
the event of the other partys uncured material breach.

The foregoing description of the Agreement does not purport to be
complete, and is qualified in its entirety by reference to the
Agreement, a copy of which we expect to file with our Quarterly
Report on Form 10-Q for the quarter ending June30, 2017. A copy
of the Prior Agreement was filed with our Annual Report on Form
10-K for the fiscal year ending December31, 2016 and is
incorporated herein by reference.

Forward-Looking Statements

This current report includes forward-looking statements. Such
forward-looking statements include those about Akebias
collaboration with Otsuka, including statements regarding the
anticipated contributions from Otsuka to the Agreement, Otsukas
responsibilities to the Agreement and expectations for Otsukas
funding obligations to the Agreement, and the potential
commercialization of vadadustat if approved by regulatory
authorities. 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
Akebia will not achieve development or commercial milestones with
vadadustat; the ability of Akebia or its collaborators to
successfully complete the clinical development of vadadustat;
that the funding required to develop Akebias product candidates
and operate the company and the actual expenses associated
therewith may be greater than currently anticipated by
management; the actual costs incurred in the global Phase 3
program for vadadustat and the availability of financing to cover
such costs; the timing of any additional studies initiated by
Akebia or its collaborators for vadadustat; the timing and
content of decisions made by regulatory authorities; potential
delays in Akebias clinical programs as a result of capital
constraints; 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; and Akebias ability to obtain,
maintain and enforce patent and other intellectual property
protection for vadadustat around the world. Other risks and
uncertainties include those identified under the heading Risk
Factors in Akebias Annual Report on Form 10-K for the year ended
December31, 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 current report.

The information contained in this Item shall not be deemed filed
for any purpose, and shall not be deemed incorporated by
reference in any filing under the Securities Act of 1933, as
amended, or the Securities Exchange Act of 1934, as amended,
regardless of any general incorporation language in any such
filing.

On April25, 2017, the Company issued a press release announcing
the agreement described in Item1.01 of this Current Report on
Form 8-K. A copy of the press release is attached to this report
as Exhibit 99.1.

(d)

About AKEBIA THERAPEUTICS, INC. (NASDAQ:AKBA)

Akebia Therapeutics, Inc. is a biopharmaceutical company. The Company is focused on the development of therapeutics based on hypoxia inducible factor (HIF) biology, and the commercialization of these products for patients with serious medical needs. The Company’s segment is the business of developing and commercializing proprietary therapeutics based on HIF biology. The Company is involved in developing its lead product candidate, vadadustat, as an oral therapy for the treatment of anemia in chronic kidney disease (CKD) subjects not on dialysis and in subjects on dialysis. Its other clinical candidate, AKB-6899, is designed as a small molecule HIF prolyl-hydroxylase (HIF-PH) inhibitor with therapeutic benefit in oncology and ophthalmology. The Company is engaged in conducting approximately two global Phase III studies for the treatment of anemia in non-dialysis dependent patients, and over two Phase III studies for the treatment of anemia in dialysis-dependent CKD patients.

AKEBIA THERAPEUTICS, INC. (NASDAQ:AKBA) Recent Trading Information

AKEBIA THERAPEUTICS, INC. (NASDAQ:AKBA) closed its last trading session up +0.06 at 9.37 with 171,636 shares trading hands.