- Akebia announces late filing of its second quarter earnings and
Form 10-Q
- Akebia reaffirms 2023 net product revenue guidance of
$175 - $180
million
- Akebia believes its cash resources as of June 30, 2023 will be sufficient to fund its
current operating plan through at least the next twelve months
- Akebia expects to resubmit NDA for vadadustat as a treatment
for anemia due to CKD in adult patients on dialysis in Q3 2023
CAMBRIDGE, Mass., Aug. 10,
2023 /PRNewswire/ -- Akebia Therapeutics®,
Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose
to better the lives of people impacted by kidney disease, today
announced that it has filed with the U.S. Securities and Exchange
Commission (SEC) a Form 12b-25 Notification of Late Filing with
regard to its Quarterly Report on Form 10Q for the quarter ended
June 30, 2023.
Through the course of preparing its financial statements for the
second quarter, Akebia identified certain accounting errors
relating to recording and reporting of return reserves for Auryxia®
(ferric citrate). Akebia does not currently anticipate that the
correction of the accounting errors will impact Akebia's previously
issued 2023 Auryxia net product revenue guidance of $175-180 million. In addition, based on its
current operating plan, Akebia believes that its cash resources as
of June 30, 2023 and revenues from
Auryxia will be sufficient to allow Akebia to fund its current
operating plan through at least the next twelve months from the
date of this filing.
The delay in filing will not affect Akebia's ability to serve
existing or new patients. Akebia continues to expect to resubmit
its New Drug Application for vadadustat as a treatment for anemia
due to chronic kidney disease in adult patients on dialysis by the
end of this quarter.
About Akebia Therapeutics
Akebia Therapeutics, Inc. is
a fully integrated biopharmaceutical company with the purpose to
better the lives of people impacted by kidney disease. Akebia was
founded in 2007 and is headquartered in Cambridge, Massachusetts. For more
information, please visit our website at www.akebia.com, which does
not form a part of this release.
About Vadadustat
Vadadustat is an oral
hypoxia-inducible factor prolyl hydroxylase inhibitor designed to
mimic the physiologic effect of altitude on oxygen availability. At
higher altitudes, the body responds to lower oxygen availability
with stabilization of hypoxia-inducible factor, which can lead to
increased red blood cell production and improved oxygen delivery to
tissues. Vadadustat is not approved by the U.S. Food and Drug
Administration. Vadadustat is approved in Europe for the treatment of symptomatic anemia
due to CKD in adult patients on chronic maintenance dialysis. In
Japan, vadadustat is approved as a
treatment for anemia due to CKD in both dialysis-dependent and
non-dialysis dependent adult patients.
IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA (ferric
citrate) CONTRAINDICATION
AURYXIA (ferric citrate) is contraindicated in patients with
iron overload syndromes, e.g., hemochromatosis.
WARNINGS AND PRECAUTIONS
- Iron Overload: Increases in serum ferritin and
transferrin saturation (TSAT) were observed in clinical trials with
AURYXIA in patients with chronic kidney disease (CKD) on dialysis
treated for hyperphosphatemia, which may lead to excessive
elevations in iron stores. Assess iron parameters prior to
initiating AURYXIA and monitor while on therapy. Patients receiving
concomitant intravenous (IV) iron may require a reduction in dose
or discontinuation of IV iron therapy.
- Risk of Overdosage in Children Due to Accidental
Ingestion: Accidental ingestion and resulting overdose of
iron-containing products is a leading cause of fatal poisoning in
children under 6 years of age. Advise patients of the risks to
children and to keep AURYXIA out of the reach of children.
ADVERSE REACTIONS
Most common adverse reactions with AURYXIA were:
- Hyperphosphatemia in CKD on Dialysis: Diarrhea (21%),
discolored feces (19%), nausea (11%), constipation (8%), vomiting
(7%) and cough (6%).
- Iron Deficiency Anemia in CKD Not on Dialysis:
Discolored feces (22%), diarrhea (21%), constipation (18%), nausea
(10%), abdominal pain (5%) and hyperkalemia (5%).
SPECIFIC POPULATIONS
- Pregnancy and Lactation: There are no available data on
AURYXIA use in pregnant women to inform a drug-associated risk of
major birth defects and miscarriage. However, an overdose of iron
in pregnant women may carry a risk for spontaneous abortion,
gestational diabetes and fetal malformation. Data from rat studies
have shown the transfer of iron into milk, hence, there is a
possibility of infant exposure when AURYXIA is administered to a
nursing woman.
To report suspected adverse reactions, contact Akebia
Therapeutics at 1-844-445-3799.
Please see full Prescribing Information
Forward-Looking Statements
Statements in this press
release regarding Akebia Therapeutics, Inc.'s ("Akebia's")
strategy, plans, prospects, expectations, beliefs, intentions and
goals are forward-looking statements within the meaning of the U.S.
Private Securities Litigation Reform Act of 1995, as amended, and
include, but are not limited to, statements regarding: Akebia's
expectations regarding the timing of filing of its Quarterly Report
on Form 10-Q; Akebia's ongoing review of its financial statements;
Akebia's expectations and plans with respect to the resubmission of
its NDA for vadadustat, including the timing thereof; Akebia's
revenue guidance for Auryxia in 2023 and assumptions related
thereto; Akebia's expectations about the impacts of the accounting
errors and the delay in filing; and Akebia's goals, objectives and
expectations with respect to its operating plan, expenses, cash
resources and sources of funding for its cash runway, including its
belief that its existing cash resources and revenues from Auryxia
will be sufficient to fund its current operating plan for at least
the next twelve months. The terms "intend," "believe," "plan,"
"goal," "expect," "potential," "will," "continue," derivatives of
these words, and similar references are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. Actual results,
performance or experience may differ materially from those
expressed or implied by any forward-looking statement as a result
of various risks, uncertainties and other factors, including, but
not limited to, risks associated with: the risk that additional
information may arise in the process of completing the review or
audit of any revised financial statements that would require Akebia
to make additional or different adjustments; the time, effort and
expense required to complete any corrections in Akebia's financial
statements; the potential demand and market potential and
acceptance of, as well as coverage and reimbursement related to,
Auryxia, including estimates regarding the potential market
opportunity; the competitive landscape for Auryxia, including
potential generic entrants; the ability of Akebia to attract and
retain qualified personnel; Akebia's ability to implement cost
avoidance measures and reduce operating expenses; decisions made by
health authorities, such as the FDA, with respect to regulatory
filings, including the anticipated resubmission of the New Drug
Application for vadadustat; the potential therapeutic benefits,
safety profile, and effectiveness of vadadustat; the results of
preclinical and clinical research; the direct or indirect impact of
the COVID-19 pandemic on regulators and Akebia's business,
operations, and the markets and communities in which Akebia and its
partners, collaborators, vendors and customers operate;
manufacturing, supply chain and quality matters and any recalls,
write-downs, impairments or other related consequences or potential
consequences; and early termination of any of Akebia's
collaborations. Other risks and uncertainties include those
identified under the heading "Risk Factors" in Akebia's Quarterly
Report on Form 10-Q for the quarter ended March 31, 2023, and other filings that Akebia may
make with the U.S. Securities and Exchange Commission in the
future. These forward-looking statements (except as otherwise
noted) speak only as of the date of this press release, and, except
as required by law, Akebia does not undertake, and specifically
disclaims, any obligation to update any forward-looking statements
contained in this press release.
Akebia Therapeutics® and Auryxia® (ferric
citrate) are registered trademarks of Akebia Therapeutics, Inc. and
its affiliates.
Akebia Therapeutics Contact
Mercedes Carrasco
mcarrasco@akebia.com
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SOURCE Akebia Therapeutics