AKEBIA THERAPEUTICS, INC. (NASDAQ:AKBA) Files An 8-K Entry into a Material Definitive Agreement
Item1.01
| Entry into a Material Definitive Agreement |
License Agreement
On May12, 2017, Akebia Therapeutics, Inc. (Akebia) entered into a
License Agreement (the Agreement) with Vifor (International) Ltd.
(Vifor), to which Akebia will grant Vifor an exclusive license to
sell vadadustat solely to Fresenius Kidney Care Group LLC (FKC),
an affiliate of Fresenius Medical Care North America, in the
United States (the Territory). Vadadustat is Akebias oral
hypoxia-inducible factor (HIF) stabilizer currently in
development for the treatment of anemia related to chronic kidney
disease (CKD).
The parties rights under the Agreement are conditioned upon the
approval of vadadustat for dialysis-dependent CKD patients by the
U.S. Food and Drug Administration (FDA), inclusion of vadadustat
in a bundled reimbursement model, and payment by Vifor of a
$20million milestone upon the occurrence of these two events. The
Agreement is structured as a profit share arrangement between
Akebia and Vifor in which Akebia will receive a majority of the
profit from Vifors sales of vadadustat to FKC in the Territory.
Akebia will share the milestone payment and the revenue from the
profit share with Otsuka Pharmaceutical Co., Ltd. (Otsuka) to
Akebias Collaboration and License Agreement with Otsuka in the
United States. Akebia retains all rights to commercialize
vadadustat for use in the non-dialysis dependent CKD market and
in other dialysis organizations in the Territory, which will be
done in collaboration with Otsuka following FDA approval.
Prior to FDA approval of vadadustat, Akebia and Vifor will enter
into a commercial supply agreement for vadadustat to which Akebia
will supply all of Vifors requirements for vadadustat in the
Territory. In addition, Vifor will enter into a supply agreement
with FKC that will govern the terms to which Vifor will supply
vadadustat to FKC for use in patients at its dialysis centers.
During the term of the Agreement, Vifor will not sell to FKC or
its affiliates any HIF product that competes with vadadustat in
the Territory.
Unless earlier terminated, the Agreement will expire upon the
later of the expiration of all patents that claim or cover
vadadustat, or expiration of data or regulatory exclusivity for
vadadustat in the Territory. Vifor may terminate the Agreement
its entirety upon 12 months prior written notice after the
release of the first topline data in the vadadustat global Phase
3 program for dialysis-dependent CKD patients. Either party may,
subject to a cure period, terminate the Agreement in the event of
the other partys uncured material breach. Akebia may also
terminate the Agreement upon the occurrence of other events, such
as for specific violations of the Agreement or if there are
changes in Vifors relationship with FKC.
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.
Investment Agreement
In connection with the Agreement, on May12, 2017, Akebia and
Vifor entered into an investment agreement (the Investment
Agreement) to which Akebia sold an aggregate of 3,571,429 shares
of common stock (the Shares), par value $0.00001 per share, to
Vifor at a price per share of $14, which is approximately a 40%
premium to Akebias 90-day average stock price, for a total of
$50million dollars.
Vifor has agreed to a lock-up restriction such that it agrees not
to sell its shares for a period of time following the effective
date of the Investment Agreement as well as a customary
standstill agreement. In addition, the Investment Agreement
contains voting agreements made by Vifor with respect to the
Shares. The Shares have not been registered to Securities Act of
1933 (the Act) and were issued and sold in reliance upon the
exemption from registration contained in Section 4(a)(2) of the
Act and Rule 506 promulgated thereunder.
The foregoing description of the Investment Agreement does not
purport to be complete and is qualified in its entirety by
reference to the Investment Agreement, a copy of which we expect
to file with our Quarterly Report on Form 10-Q for the quarter
ending June30, 2017.
| Item3.02 | Unregistered Sales of Equity Securities |
The information regarding the Investment Agreement set forth in
Item 1.01 is incorporated herein by reference.
Forward-Looking Statements
This current report includes forward-looking statements. Such
forward-looking statements include those about Akebias strategy,
future plans and prospects, including statements about Akebias
relationship with Vifor, statements regarding the anticipated
milestone and profit sharing payments from Vifor to the
Agreement, and the potential commercialization of vadadustat if
approved by the FDA. 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 the milestone;
the potential termination of the Agreement by Akebia or Vifor;
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 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. Other risks and uncertainties include
those identified under the heading Risk Factors in Akebias
Quarterly Report on Form 10-Q for the quarter ended
March31, 2017, 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.
| Item7.01 | Regulation FD Disclosure |
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 May15, 2017,
the Company issued a press release announcing the agreements
described in Items 1.01 and 3.02 of this Current Report on Form
8-K. A copy of the
press release is attached to this report as Exhibit
99.1.
| Item9.01 | Financial Statements and Exhibits |
99.1 Press release of Akebia
Therapeutics, Inc. dated May15, 2017
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 +0.21 at 12.90 with 496,717 shares trading hands.