Akebia to host conference call at 8:00 a.m. ET
- Vadadustat NDA assigned a PDUFA date of March 27, 2024
- Vadadustat approved in 36 countries, including Australia and Taiwan
- Akebia strengthens cash position modifying Pharmakon loan
- Auryxia® (ferric citrate) quarterly net product revenue of
$40.1 million
CAMBRIDGE, Mass., Nov. 8, 2023
/PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq:
AKBA), a biopharmaceutical company with the purpose to better the
lives of people impacted by kidney disease, today reported
financial results for the third quarter ended September 30, 2023 and reviewed recent business
highlights.
In September, Akebia completed its resubmission to its New
Drug Application for vadadustat to the U.S. Food and Drug
Administration (FDA) as a treatment for anemia due to chronic
kidney disease (CKD) in adult patients on dialysis. FDA
subsequently accepted the resubmission and assigned a user fee goal
date ("PDUFA date") of March 27,
2024. The resubmission includes post-marketing safety data
from tens of thousands of patients in Japan where vadadustat
is approved and has been in the market for more than three
years.
"Akebia is extremely well-positioned following the acceptance of
our vadadustat NDA resubmission, with a March 27, 2024 PDUFA date," said John P. Butler, Chief Executive Officer of
Akebia. "We are preparing for a commercial launch if vadadustat is
approved and stand ready with a commercial team in place and
product supply on the shelf. We also added Australia and Taiwan to the list of countries where
vadadustat is approved for CKD patients on dialysis. Additionally,
we have strengthened our financial position by deferring our
Pharmakon principal payments until October
2024."
Auryxia® (ferric citrate) net product revenue
for the third quarter was $40.1
million and management reaffirms previously issued 2023 net
product revenue guidance of $170.0 -
$175.0 million for Auryxia.
Third Quarter 2023 and Recent Business Highlights
- Australia's Therapeutic Goods
Administration granted approval for Vafseo® (vadadustat)
for the treatment of anemia associated with CKD in adults on
chronic maintenance dialysis. Vadadustat was also authorized for
use in Taiwan during this time,
marking approval in 36 countries.
- Akebia supported five posters presented at the American Society
of Nephrology Kidney Week 2023, which took place on November 2-5, 2023. Notably, one poster presented
data on a potential alternative dosing regimen for vadadustat.
- Akebia modified the terms of its loan agreement with Pharmakon
Advisors, LP to extend the maturity of the loan from November 2024 until March
2025, and to defer its principal payments until October 31, 2024.
Third Quarter Financial Results
Total Revenues: Total revenues were $42.0 million for the third quarter of 2023,
compared to $48.7 million for the
third quarter of 2022. The decrease is primarily due to a decrease
in license, collaboration and other revenue.
Net Product Revenues: Net product revenues were
$40.1 million for the third quarter
of 2023, compared to $42.0 million
for the third quarter of 2022. The decrease was primarily due to a
reduction in volume and the impact of shifting payor mix, partially
caused by contracting dynamics and a decline in the phosphate
binder market. The decline was partially offset by price increases
in January 2023 and July 2023.
License, Collaboration and Other Revenues: License,
collaboration and other revenues were $1.9
million for the third quarter of 2023, compared to
$6.7 million for the third quarter of
2022. The decrease is primarily due to the transfer and assignment
of a supply agreement to Akebia's collaboration partner.
Cost of Goods Sold (COGS): COGS was $18.0 million for the third quarter of 2023,
compared to $38.3 million for the
third quarter of 2022. COGS reflects the costs of Auryxia,
including non-cash intangible amortization charge of $9.0 million per quarter through the fourth
quarter of 2024 and third-party royalties. The decrease was
primarily due to a reduction in a non-cash charge related to the
prior liability for excess purchase commitments, a decrease in
inventory write-downs and lower volume of sales resulting in
reduced product costs.
Research and Development (R&D) Expenses: R&D
expenses were $13.3 million for the
third quarter of 2023, compared to $28.0
million for the third quarter of 2022. The decrease was
primarily due to a reduction in spending for vadadustat
development, including clinical trial costs, and curtailment of
outsourced contract services.
Selling, General and Administrative (SG&A)
Expenses: SG&A expenses were $22.7 million for the third quarter of 2023,
compared to $31.9 million for the
third quarter of 2022. The decrease was primarily due to a
reduction in headcount related costs, the benefits realized from
the assignment of the Boston lease
in May 2023 and a targeted cutback in
Auryxia marketing and promotional expense which were offset by some
one-time non-recurring expenses.
Net Loss: Net loss was $14.5
million for the third quarter of 2023, compared to net loss
of $54.1 million for the third
quarter of 2022.
Cash Position: Cash, cash equivalents and restricted cash
as of September 30, 2023, totaled
$48.2 million. Akebia expects its
existing cash resources and cash from operations will be sufficient
to fund its current operating plan for at least the next twelve
months.
Conference Call Information
Akebia will host a conference call and webcast on Wednesday, November 8 at 8:00 a.m. ET to discuss its financial results and
recent business highlights. To access the call, please register by
clicking on this Registration Link, and you will be provided
with dial in details. To avoid delays and ensure timely connection,
we encourage dialing into the conference call 15 minutes ahead of
the scheduled start time.
A live webcast of the conference call will be available via the
"Investors" section of Akebia's website at: https://ir.akebia.com/.
An online archive of the webcast can be accessed via the Investors
section of Akebia's website at https://ir.akebia.com approximately
two hours after the event.
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, Australia and Taiwan 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 SAFETY INFORMATION FOR VAFSEO (vadadustat)
For safety information, view the European Summary of Product
Characteristics (SPC/SmPC) for Vafseo® (vadadustat) at
https://ec.europa.eu/health/documents/community-register/2023/20230424158854/anx_158854_en.pdf,
https://products.mhra.gov.uk/ and
https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisations/swisspar.html
and will be available via the Australian Therapeutic Goods
Administration website here.
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 click to see the full Prescribing Information for
AURYXIA.
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: the
anticipated scheduled PDUFA date for vadadustat; Akebia's ability
to enable a successful commercial launch of vadadustat if approved;
Akebia's expectations and beliefs regarding the impact that the
amendment with Pharmakon will have on Akebia; Akebia's revenue
guidance for Auryxia in 2023 and assumptions related thereto; 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 cash from operations will be sufficient to fund its
current operating plan for at least the next twelve months. The
terms "intend," "believe," "plan," "goal," "expect," "potential,"
"anticipate," "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 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 FDA decision on the NDA for
vadadustat and the potential effects of a negative decision on
Akebia's cash runway; 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 June 30, 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®, Auryxia® and
Vafseo® are registered trademarks of Akebia
Therapeutics, Inc. and its affiliates.
Akebia Therapeutics Contact
Mercedes Carrasco
mcarrasco@akebia.com
AKEBIA THERAPEUTICS,
INC.
|
Unaudited Condensed
Consolidated Statements of Operations
|
|
|
Three Months Ended
September 30,
|
(in thousands,
except per share data)
|
2023
|
|
2022
|
Revenues
|
|
|
|
Product revenue,
net
|
$
40,118
|
|
$
41,989
|
License, collaboration
and other revenue
|
1,928
|
|
6,725
|
Total
revenues
|
42,046
|
|
48,714
|
Cost of goods
sold
|
|
|
|
Product
|
8,998
|
|
29,270
|
Amortization of
intangible asset
|
9,011
|
|
9,011
|
Total cost of goods
sold
|
18,009
|
|
38,281
|
Operating
expenses
|
|
|
|
Research and
development
|
13,330
|
|
28,028
|
Selling, general and
administrative
|
22,710
|
|
31,887
|
License
expense
|
864
|
|
743
|
Restructuring
|
169
|
|
180
|
Total operating
expenses
|
37,073
|
|
60,838
|
Loss from
operations
|
(13,036)
|
|
(50,405)
|
Other expense,
net
|
(1,453)
|
|
(2,785)
|
Loss on extinguishment
of debt
|
—
|
|
(906)
|
Net
loss
|
$
(14,489)
|
|
$
(54,096)
|
Net loss per share -
basic and diluted
|
$(0.08)
|
|
$(0.29)
|
Weighted-average number
of common shares - basic and diluted
|
188,306
|
|
183,882
|
|
|
Unaudited Selected
Balance Sheet Data
|
|
(in
thousands)
|
September 30,
2023
|
|
December 31,
2022
|
Cash and cash
equivalents
|
$
46,529
|
|
$
90,466
|
Working
capital
|
$
29,900
|
|
$
55,646
|
Total assets
|
$
234,998
|
|
$
356,054
|
Total stockholders'
(deficit) equity
|
$
(39,422)
|
|
$
5,230
|
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SOURCE Akebia Therapeutics