Akebia to host conference call at 8:00 a.m. ET on May
9
- Vafseo® (vadadustat) tablets FDA approved on March 27, 2024
- Vafseo launch activities underway with availability expected
in January 2025
- Auryxia® (ferric citrate) net product revenues were
$31.0 million for the first
quarter 2024, Akebia expects 2024 Auryxia net product revenue
growth versus 2023
CAMBRIDGE, Mass., May 9, 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 first quarter ended March 31,
2024. Akebia is launching Vafseo® (vadadustat) tablets,
recently approved by the U.S. Food and Drug Administration (FDA)
for the treatment of anemia due to chronic kidney disease (CKD) in
adults who have been receiving dialysis for at least three months,
which will be available in January
2025.
"The recent FDA approval of Vafseo represents a transformational
milestone for Akebia as we initiate launch activities that we
believe will enable widespread access and rapid adoption when
Vafseo is available in January 2025,"
said John P. Butler, Chief Executive
Officer of Akebia. "Upon FDA approval of Vafseo, we initiated work
to drive demand from potential prescribers and to contract with
dialysis providers. We are progressing plans for generating
clinical data to identify additional areas of potential benefit to
patients as we remain committed to the kidney community. We also
expect to engage with the FDA on label expansion opportunities for
Vafseo by the end of this year."
Recent Business Highlights
- Akebia plans to submit its application for Transitional Drug
Add-on Payment Adjustment (TDAPA) for Vafseo in June. Akebia
expects the application to be accepted in July 2024 and expects TDAPA designation in
January 2025.
- In March, Akebia presented posters at the 2024 Annual Dialysis
Conference on the cardiovascular safety of vadadustat in patients
new to dialysis with CKD-related anemia and the safety and efficacy
of vadadustat in the treatment of anemia in U.S. patients with
CKD.
- In April, Akebia's licensee Averoa, a biopharmaceutical
company, submitted a marketing authorization application to the
European Medicines Agency for Ferric Citrate Coordination Complex,
and, if approved, Averoa will make the product available to
patients in Europe.
- In April, Akebia drew down the second tranche of its
$55.0 million BlackRock debt facility
and received net proceeds of $7.5
million. Ten million dollars
of borrowing capacity remains available under the debt facility
until December 31, 2024, subject to
the conditions in the loan agreement.
- In May, Akebia signed an amendment to its License Agreement
with Vifor International Ltd. (Vifor) to modify the method of
repayment of its working capital fund through tiered royalties
based upon Akebia's sales of Vafseo, significantly simplifying the
repayment terms.
Akebia reported first quarter 2024 Auryxia® (ferric citrate) net
product revenues of $31.0 million.
Akebia reaffirms that it expects Auryxia net product revenue growth
in 2024 versus 2023. The Centers for Medicare and Medicaid Services
released guidance on incorporating phosphate binders, including
Auryxia, into the dialysis bundle in January
2025. Akebia is accelerating contracting discussions with
dialysis organizations with a goal to ensure broad access to
Auryxia.
"With continued revenue contributions from Auryxia, revenue from
Vafseo beginning in 2025, and our current cash balance, we believe
we have sufficient cash to support operations for at least the next
two years while investing in the Vafseo launch," Mr. Butler
added.
Financial Results
- Revenues: Total revenues were $32.6 million for the first quarter of 2024
compared to $40.0 million for the
first quarter of 2023.
- Net product revenues were $31.0
million for the first quarter of 2024 compared to
$34.7 million for the first quarter
of 2023.
- License, collaboration and other revenues were $1.6 million for the first quarter of 2024
compared to $5.3 million for the
first quarter of 2023.
- COGS: Cost of goods sold was $11.6 million for the first quarter of 2024
compared to $20.2 million for the
first quarter of 2023. Akebia continues to carry 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
$9.7 million for the first quarter of
2024 compared to $19.7 million for
the first quarter of 2023.
- SG&A Expenses: Selling, general and administrative
expenses were $25.4 million for the
first quarter of 2024 compared to $25.1
million for the first quarter of 2023.
- Net Income / Loss: Net loss was $18.0 million for the first quarter of 2024
compared to a net loss of $26.9
million for the first quarter of 2023.
- Cash Position: Cash and cash equivalents as of
March 31, 2024, were approximately
$42.0 million. Akebia expects its
existing cash resources and cash from operations will be sufficient
to fund its current operating plan, including a U.S. Vafseo launch,
for at least the next two years.
Conference Call
Akebia will host a conference call on Thursday, May 9 at 8:00
a.m. Eastern Time to discuss first quarter 2024 earnings. 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 Vafseo® (vadadustat) tablets
Vafseo® (vadadustat) tablets is a once-daily oral
hypoxia-inducible factor prolyl hydroxylase inhibitor that
activates the physiologic response to hypoxia to stimulate
endogenous production of erythropoietin, increasing hemoglobin and
red blood cell production to manage anemia. Vafseo is approved for
use in 37 countries.
INDICATION
VAFSEO is indicated for the treatment of
anemia due to chronic kidney disease (CKD) in adults who have been
receiving dialysis for at least three months.
Limitations of Use
- VAFSEO has not been shown to improve quality of life, fatigue,
or patient well-being.
- VAFSEO is not indicated for use:
- As a substitute for red blood cell transfusions in patients who
require immediate correction of anemia.
- In patients with anemia due to CKD not on dialysis.
IMPORTANT SAFETY INFORMATION about VAFSEO (vadadustat)
tablets
|
WARNING: INCREASED
RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS
THROMBOEMBOLISM, and THROMBOSIS OF VASCULAR ACCESS.
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|
See full
prescribing information for complete boxed
warning.
|
|
VAFSEO increases the
risk of thrombotic vascular events, including major adverse
cardiovascular events (MACE).
|
|
Targeting a
hemoglobin level greater than 11 g/dL is expected to further
increase the risk of death and arterial and venous thrombotic
events, as occurs with erythropoietin stimulating agents (ESAs),
which also increase erythropoietin levels.
|
|
No trial has
identified a hemoglobin target level, dose of VAFSEO, or dosing
strategy that does not increase these risks.
|
|
Use the lowest dose
of VAFSEO sufficient to reduce the need for red blood cell
transfusions.
|
|
CONTRAINDICATIONS
- Known hypersensitivity to VAFSEO or any of its
components
- Uncontrolled hypertension
WARNINGS AND PRECAUTIONS
- Increased Risk of Death, Myocardial Infarction, Stroke,
Venous Thromboembolism, and Thrombosis of Vascular
Access
A rise in hemoglobin (Hb) levels greater than
1 g/dL over 2 weeks can increase these
risks. Avoid use in patients with a history of myocardial
infarction, cerebrovascular event, or acute coronary
syndrome within the 3 months prior to starting VAFSEO.
Targeting a Hb level of greater than 11g/dL
is expected to further increase the risk of death and
arterial and venous thrombotic events, as occurs with
ESAs, which also increase erythropoietin levels.
No specific Hb target level, dose of
VAFSEO, or dosing strategy has been identified to avoid these
risks. Use the lowest effective dose and adhere to dosing
and Hb monitoring recommendations to avoid
excessive erythropoiesis.
Advise patients to seek immediate medical attention if
they develop signs or symptoms of myocardial infarction, stroke,
venous thromboembolism, or thrombosis of vascular access.
Evaluate and manage promptly if these occur.
- Hepatotoxicity
Hepatocellular injury attributed
to VAFSEO was reported in less than 1% of patients,
including one severe case with jaundice. All events were
asymptomatic and resolved after discontinuation of
VAFSEO. The time to onset was generally within the first 3
months of treatment. Elevated serum ALT, AST,
and bilirubin levels were observed in 1.8%, 1.8%, and
0.3% of CKD patients treated with VAFSEO,
respectively. Measure ALT, AST, and bilirubin
before treatment and monthly for the first 6 months, then as
clinically indicated. Discontinue VAFSEO if ALT
or AST is persistently elevated or accompanied by
elevated bilirubin. Not recommended in patients with
cirrhosis or active, acute liver disease.
- Hypertension
Worsening of hypertension was reported
in 14% (9.4 per 100 person-years [PY]) of patients
receiving VAFSEO and 17% (11.8 per 100
PY) of patients receiving darbepoetin alfa.
Serious worsening of hypertension was reported in 2.7% (1.7 per
100 PY) of patients receiving VAFSEO and
3% (1.8 per 100 PY) of patients receiving
darbepoetin alfa. Cases of hypertensive crisis including
hypertensive encephalopathy and seizures have also
been reported in patients receiving VAFSEO. Monitor
blood pressure. Adjust anti-hypertensive therapy as needed.
- Seizures
Seizures occurred in 1.6% (1.0 per 100 PY) of patients who
received VAFSEO and 1.6% (1.0 per 100 PY)
of patients who received darbepoetin alfa. Following
initiation of VAFSEO, monitor patients closely for
premonitory neurologic symptoms. Monitor for new-onset
seizures, premonitory symptoms, or change in seizure frequency.
- Gastrointestinal Erosion
Gastric or esophageal
erosions occurred in 6.4% (4.0 per 100 PY) of patients
receiving VAFSEO and 5.3% (3.3 per 100
PY) of darbepoetin alfa-treated patients.
Serious gastrointestinal (GI) erosions, including GI bleeding and
the need for red blood cell transfusions were reported in 3.4% (2.1
per 100 PY) and 3.3% (2.0 per 100 PY) of
those receiving VAFSEO and darbepoetin
alfa, respectively. Consider the risk of GI erosion in
high-risk patients, including those with a history of GI erosion,
peptic ulcer disease, and tobacco or alcohol use.
Advise patients of the signs and symptoms of erosions
and GI bleeding and urge them to seek prompt medical care if
present.
- Serious Adverse Reactions in Patients with Anemia Due to
Chronic Kidney Disease and Not on Dialysis
The safety of
VAFSEO has not been established for the treatment of anemia
due to CKD in adults not on dialysis and its use is
not recommended in this setting. In large clinical trials in adults
with anemia of CKD who were not on dialysis, an
increased risk of mortality, stroke, myocardial infarction, serious
acute kidney injury, serious hepatic injury, and serious GI
erosions was observed in patients treated with VAFSEO
compared to darbepoetin alfa.
- Malignancy
VAFSEO has not been studied and is
not recommended in patients with active malignancies. Malignancies
were observed in 2.2% (1.3 per 100 PY) of patients
treated with VAFSEO and 3.0% (1.8 per 100
PY) of patients treated with darbepoetin alfa.
No evidence of increased carcinogenicity was observed
in animal studies.
ADVERSE REACTIONS
- The most common adverse reactions (occurring at ≥ 10%) were
hypertension and diarrhea.
DRUG INTERACTIONS
- Iron supplements and iron-containing phosphate binders:
Administer VAFSEO at least 1 hour before products containing
iron.
- Non-iron-containing phosphate binders: Administer VAFSEO
at least 1 hour before or 2 hours after non-iron-containing
phosphate binders.
- BCRP substrates: Monitor for signs of substrate adverse
reactions and consider dose reduction.
- Statins: Monitor for statin-related adverse reactions.
Limit the daily dose of simvastatin (20 mg) and rosuvastatin (5
mg).
USE IN SPECIFIC POPULATIONS
- Pregnancy: May cause fetal harm.
- Lactation: Breastfeeding not recommended until two days
after the final dose.
- Hepatic Impairment: Not recommended for use in patients
with cirrhosis or active, acute liver disease.
Please note that this information is not comprehensive.
Please click here for the Full Prescribing Information, including
BOXED WARNING and Medication Guide.
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: Akebia's plans with respect to the commercial launch of
Vafseo; timing of the commercial availability of Vafseo, including
the belief that launch activities will enable widespread access and
rapid adoption when Vafseo is available in January 2025; expectations with respect to
Akebia's application for Transitional Drug Add-on Payment
Adjustment (TDAPA) for Vafseo and TDAPA designation, including the
timing thereof; plans regarding potential label expansion; plans to
generate clinical data to identify additional areas of potential
benefits to patients; Akebia's expectations with respect to
engagement with the FDA on label expansion and the timing thereof;
Akebia's expectations for Auryxia net product revenue growth in
2024 and assumptions related thereto; Akebia's goal of ensuring
broad access to Auryxia; 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 revenue are sufficient to fund its current
operating plan, including a U.S. Vafseo launch, for at least the
next two years. 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: whether Vafseo will be commercially
available when expected; the potential demand and market potential
and acceptance of, as well as coverage and reimbursement related
to, Auryxia® and Vafseo, including estimates regarding the
potential market opportunity; the competitive landscape for Auryxia
and Vafseo, 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; the potential therapeutic benefits, safety
profile, and effectiveness of Vafseo; the results of preclinical
and clinical research; the direct or indirect impact of the
COVID-19 pandemic on 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, 2024, 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
March 31,
|
(in thousands,
except per share data)
|
2024
|
|
2023
|
Revenues
|
|
|
|
Product revenue,
net
|
$
31,009
|
|
$
34,706
|
License, collaboration
and other revenue
|
1,598
|
|
5,299
|
Total
revenues
|
32,607
|
|
40,005
|
Cost of goods
sold
|
|
|
|
Cost of product and
other revenue
|
2,594
|
|
11,178
|
Amortization of
intangible asset
|
9,011
|
|
9,011
|
Total cost of goods
sold
|
11,605
|
|
20,189
|
Operating
expenses
|
|
|
|
Research and
development
|
9,731
|
|
19,686
|
Selling, general and
administrative
|
25,438
|
|
25,053
|
License
expense
|
711
|
|
568
|
Restructuring
|
58
|
|
106
|
Total operating
expenses
|
35,938
|
|
45,413
|
Loss from
operations
|
(14,936)
|
|
(25,597)
|
Other expense,
net
|
(2,403)
|
|
(1,279)
|
Change in fair value of
warrant liability
|
(129)
|
|
—
|
Loss on extinguishment
of debt
|
(517)
|
|
—
|
Net
loss
|
$
(17,985)
|
|
$
(26,876)
|
|
|
|
|
Net loss per share -
basic and diluted
|
$(0.09)
|
|
$(0.15)
|
Weighted-average number
of common shares - basic and diluted
|
204,955,151
|
|
184,768,983
|
Unaudited Selected
Balance Sheet Data
|
|
(in
thousands)
|
March 31,
2024
|
|
December 31,
2023
|
Cash and cash
equivalents
|
$
41,961
|
|
$
42,925
|
Working
capital
|
$
46,457
|
|
$
18,279
|
Total assets
|
$
225,477
|
|
$
241,703
|
Total stockholders'
(deficit) equity
|
$
(27,258)
|
|
$
(30,584)
|
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SOURCE Akebia Therapeutics, Inc.