Potential vadadustat U.S. approval on PDUFA
date of March 27, 2024
Strengthened balance sheet with $55.0 million term loan financing and
$26.0 million in proceeds from
ATM
Reported 2023 Auryxia (ferric citrate) net
product revenue of $170.3
million
CAMBRIDGE, Mass., March 14,
2024 /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 fourth quarter and full year
ended December 31, 2023 and recent
business highlights. Akebia is preparing for a potential launch of
vadadustat, which is currently under review by the U.S. Food and
Drug Administration (FDA) with a Prescription Drug User Fee Act
(PDUFA) date of March 27, 2024.
"We are eagerly awaiting the PDUFA date for vadadustat, now
within weeks, and we believe the progress we have made over the
past 12 months has positioned our team to successfully launch
vadadustat in the U.S., if approved," said John P. Butler, Chief Executive Officer of
Akebia. "A U.S. approval for vadadustat will be transformational
for Akebia and a significant step toward our goal of bettering the
lives of people impacted by kidney disease. Our team remains
dedicated to delivering an innovative oral therapeutic treatment
for anemia due to chronic kidney disease for patients on
dialysis."
Fourth Quarter 2023 and Recent Business
Highlights:
- Appointed Nicholas Grund as
Chief Commercial Officer, who brings years of expertise in
customer-facing roles to Akebia. Mr. Grund's operational,
commercial and strategic leadership experience across renal and
specialty markets will be critical as Akebia prepares for the
vadadustat launch in the U.S., if approved.
- Introduced new pipeline programs in acute care settings,
potentially for acute kidney injury or acute respiratory distress
syndrome (AKB-9090) and retinopathy of prematurity in neonates
(AKB-10108).
- Closed a new debt facility with BlackRock that provides access
to up to $55.0 million in borrowing
capacity and used the proceeds from the first tranche of
$37.0 million to pay down principal
outstanding under the then loan agreement with Pharmakon Advisors,
LP. The BlackRock debt facility, which closed on January 29, 2024, also extends the interest-only
period in the event of vadadustat approval in the U.S. on or prior
to June 30, 2024 without requiring
any principal repayment until December 31,
2026.
- Concluded its offering of common stock under its
"at-the-market" (ATM) sales agreement. Akebia raised approximately
$26.0 million in gross proceeds.
Akebia reported fourth quarter 2023 Auryxia® (ferric citrate)
net product revenues of $53.2 million
and full year 2023 revenues of $170.3
million, within Akebia's 2023 Auryxia net product revenue
guidance of $170.0 - $175.0 million.
"We are approaching a potential U.S. launch of vadadustat from
an extremely strong financial position. We expect Auryxia net
product revenue growth in 2024, with a quarterly revenue cadence
that is similar to 2023, we executed a term loan with BlackRock and
implemented other financial strategies that together we believe
will support our business operations for at least two years if
vadadustat is approved. As we move forward, we will continue to
carefully manage expenses, while investing appropriately for a
successful potential launch of vadadustat," Mr. Butler added.
Financial Results
- Revenues: Total revenues were $56.2 million for the fourth quarter of 2023
compared to $55.8 million for the
fourth quarter of 2022, and $194.6
million for the full-year 2023 compared to $292.5 million for the full-year 2022.
- Net product revenues were $53.2
million for the fourth quarter of 2023 compared to
$50.3 million for the fourth quarter
of 2022, and $170.3 million for the
full-year 2023 compared to $176.9
million for the full-year 2022.
- License, collaboration and other revenues were $3.0 million for the fourth quarter of 2023
compared to $5.5 million for the
fourth quarter of 2022, and $24.3
million for the full-year 2023 compared to $115.5 million for the full-year 2022.
- COGS: Cost of goods sold was $18.7 million for the fourth quarter of 2023
compared to a benefit of $3.4 million
for the fourth quarter of 2022, and $74.1
million for the full-year 2023 compared to $85.6 million for the full-year 2022. Akebia
continues to record a non-cash intangible amortization charge of
$9.0 million per quarter through the
fourth quarter of 2024.
- R&D Expenses: Research and development expenses were
$9.9 million for the fourth quarter
of 2023 compared to $32.1 million for
the fourth quarter of 2022, and $63.1
million for the full-year 2023 compared to $130.0 million for the full-year 2022.
- SG&A Expenses: Selling, general and administrative
expenses were $25.4 million for the
fourth quarter of 2023 compared to $29.9
million for the fourth quarter of 2022, and $100.2 million for the full-year 2023 compared to
$138.6 million for the full-year
2022.
- Net Income / Loss: Net income was $0.6 million for the fourth quarter of 2023
compared to a net loss of $6.1
million for the fourth quarter of 2022, and $51.9 million for the full-year 2023 compared to
$94.2 million for the full-year
2022.
- Cash Position: Cash and cash equivalents as of
December 31, 2023, were approximately
$42.9 million. Akebia believes its
existing cash resources and the cash it expects to generate from
product, royalty, supply and license revenues as well as the
borrowings and potential future borrowings that are available under
the BlackRock debt facility and the working capital liability are
sufficient to fund our current operating plan for at least
twenty-four months if vadadustat is approved.
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 and Australia for the treatment of symptomatic
anemia due to CKD in adult patients on chronic maintenance dialysis
and in Taiwan for the treatment of
anemia due to CKD in adult patients on 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.
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
financial results for the fourth quarter and full year ended
December 31, 2023; the anticipated
scheduled PDUFA date for vadadustat and the potential approval of
vadadustat; Akebia's ability to enable a successful commercial
launch of vadadustat, if approved; statements that a U.S. approval
for vadadustat will be transformational for Akebia; Akebia's
expectations and beliefs regarding the impact that the BlackRock
debt facility will have on Akebia; Akebia's expectations for
Auryxia revenue growth in 2024 and assumptions related thereto;
Akebia's plans with respect to vadadustat as a treatment of anemia
due to chronic kidney disease in patients on dialysis in the U.S.;
Akebia's expectations with respect to Akebia's pipeline in acute
care settings for acute kidney injury or acute respiratory distress
syndrome (AKB-9090) and retinopathy of prematurity in neonates
(AKB-10108) and market potential; 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 the cash it expects to
generate from product, royalty, supply and license revenues as well
as the borrowings and potential future borrowings that are
available under the BlackRock debt facility and the working capital
liability are sufficient to fund our current operating plan for at
least twenty-four months if vadadustat is approved. The terms
"intend," "believe," "plan," "goal," "potential," "anticipate,
"estimate," "expect," "future," "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 September 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.
|
Consolidated
Statements of Operations
|
|
|
|
|
|
|
|
|
|
Quarters Ended
December 31,
|
|
Years Ended December
31,
|
(in thousands,
except share and per share data)
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Revenues:
|
|
|
|
|
|
|
|
Product revenue,
net
|
$
53,233
|
|
$
50,280
|
|
$
170,301
|
|
$
176,949
|
License, collaboration
and other revenue
|
2,963
|
|
5,503
|
|
24,322
|
|
115,535
|
Total
revenues
|
56,196
|
|
55,783
|
|
194,623
|
|
292,484
|
Cost of goods
sold:
|
|
|
|
|
|
|
|
Cost of product and
other revenue
|
9,656
|
|
(12,439)
|
|
38,107
|
|
49,526
|
Amortization of
intangibles
|
9,010
|
|
9,010
|
|
36,042
|
|
36,042
|
Total cost of goods
sold
|
18,666
|
|
(3,429)
|
|
74,149
|
|
85,568
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
9,866
|
|
32,098
|
|
63,079
|
|
129,986
|
Selling, general and
administrative
|
25,434
|
|
29,908
|
|
100,233
|
|
138,601
|
License
expense
|
856
|
|
852
|
|
3,237
|
|
3,175
|
Restructuring
|
—
|
|
1,221
|
|
181
|
|
15,933
|
Total operating
expenses
|
36,156
|
|
64,079
|
|
166,730
|
|
287,695
|
Operating income
(loss)
|
1,374
|
|
(4,867)
|
|
(46,256)
|
|
(80,779)
|
Other income (expense),
net
|
(761)
|
|
(1,201)
|
|
(5,145)
|
|
(12,541)
|
Loss on extinguishment
of debt
|
—
|
|
—
|
|
—
|
|
(906)
|
Loss on lease
termination
|
—
|
|
—
|
|
(524)
|
|
—
|
Net income
(loss)
|
$
613
|
|
$
(6,068)
|
|
$
(51,925)
|
|
$
(94,226)
|
Net income (loss) per
share
|
|
|
|
|
|
|
|
Basic and
diluted
|
$—
|
|
$(0.03)
|
|
$(0.28)
|
|
$(0.52)
|
Weighted-average number
of common shares outstanding:
|
Basic
|
189,903,365
|
|
183,991,111
|
|
187,465,448
|
|
182,782,680
|
Diluted
|
190,496,470
|
|
183,991,111
|
|
187,465,448
|
|
182,782,680
|
Selected Balance
Sheet Data
|
(unaudited)
|
|
|
December
31,
|
(in
thousands)
|
|
2023
|
|
2022
|
Cash and cash
equivalents
|
|
$
42,925
|
|
$
90,466
|
Working
capital
|
|
$
18,279
|
|
$
55,646
|
Total assets
|
|
$
241,703
|
|
$
356,054
|
Total stockholders'
(deficit) equity
|
|
$
(30,584)
|
|
$
5,230
|
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SOURCE Akebia Therapeutics, Inc.