Akebia to host conference call on August 25, 2023 at 9:00
a.m. ET
- Expects to resubmit NDA for vadadustat as a treatment for
anemia due to CKD in adult patients on dialysis in Q3 2023
- Reports Auryxia® (ferric citrate) net product
revenue of $42.2 million for Q2 2023
and reaffirms 2023 net product revenue guidance of $175.0-$180.0
million
CAMBRIDGE, Mass., Aug. 25,
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 second
quarter ended June 30, 2023 and
reviewed recent business highlights. Akebia intends to file an
amendment to 2022 Annual Report on Form 10-K to revise previously
filed financial statements.
In July, Akebia completed an End of Dispute Type A meeting with
the U.S. Food and Drug Administration (FDA) to discuss Akebia's
anticipated resubmission of its New Drug Application (NDA) for
vadadustat as a treatment for anemia due to chronic kidney disease
(CKD) in adult patients on dialysis and received the FDA's Meeting
Minutes in August. Akebia plans to resubmit its NDA for vadadustat
by the end of this quarter with a potential PDUFA date projected in
March 2024.
Akebia reported Auryxia® (ferric citrate) net product
revenue of $42.2 million for the
second quarter of 2023. Akebia also reaffirmed previously issued
2023 Auryxia net product revenue guidance of $175.0 - $180.0
million.
"Through 2023 we have worked to best position Akebia to deliver
a new potential oral treatment option for anemia due to CKD to
dialysis patients around the globe," said John P. Butler, Chief Executive Officer of
Akebia. "This past quarter alone we made remarkable progress by
gaining approval for vadadustat in 33 additional countries,
securing Medice as our partner to bring Vafseo to patients in
Europe in 2024 and clarifying the
path to resubmission of the vadadustat NDA in the U.S. These
impactful milestones mark significant progress toward our purpose
to better the lives of people impacted by kidney disease."
Akebia reported additional business highlights in the second
quarter:
- The European Commission, United Kingdom Medicines and
Healthcare products Regulatory Agency and Swiss Agency for
Therapeutic Products approved Vafseo for the treatment of
symptomatic anemia associated with chronic kidney disease in adults
on chronic maintenance dialysis. Akebia expects a regulatory
opinion on vadadustat in Australia
this year. With these additional approvals, vadadustat is now
approved in 34 countries.
- In May, Akebia entered into an exclusive license agreement with
MEDICE Arzneimittel Pütter GmbH&Co.KG (Medice), granting Medice
the rights to market and sell Vafseo in the European Economic Area,
the United Kingdom, Switzerland and Australia. Under the terms of the agreement,
Akebia recognized an upfront payment of $10.0 million, and is eligible for commercial
milestone payments up to an aggregate of $100.0 million and tiered royalty payments
ranging from 10% to 30% of Medice's net sales.
- Akebia strengthened its management team, announcing that
Ellen Snow joined as Senior Vice
President, Chief Financial Officer and Treasurer. Most recently
serving in a leadership role within a commercial pharmaceutical
organization, Ms. Snow brings more than 25 years of accounting and
financial management expertise to the role, critical as Akebia
moves toward a launch of vadadustat in the U.S. next year, if
approved.
- In June, Akebia reported positive topline results from IMPACT,
a Phase 4 collaborative study investigating the impact of Auryxia,
when used as the primary phosphate-lowering therapy, on the
utilization of erythropoiesis-stimulating agent and intravenous
iron as well as on laboratory parameters indicative of phosphate
and anemia management compared to the standard of care in adult
patients with CKD on dialysis.
Q2 2023 Financial Results
- Revenues: Total revenue was $56.4 million for the second quarter of 2023
compared to $126.4 million for the
second quarter of 2022.
-
- Net product revenue was $42.2
million for the second quarter of 2023 compared to
$43.3 million for the second quarter
of 2022, an 2.5% decrease, and compared with $34.7 million for the first quarter of 2023, a
21.6% increase. The decrease compared to the second quarter of 2022
is primarily due to the impact of shifting payor mix and a volume
decrease partially caused by contracting dynamics and a decline in
the phosphate binder market. The increase compared to the first
quarter of 2023 was due to timing of purchases of Auryxia made by
certain customers and expected cyclical demand growth from the
first quarter to the second quarter. Akebia has affirmed its 2023
Auryxia net product revenue guidance of $175.0 - $180.0
million.
- License, collaboration and other revenue was $14.1 million for the second quarter of 2023
compared to $83.1 million for the
second quarter of 2022. The decrease is primarily related to the
non-recurring impact on the second quarter of 2022 of the
termination and settlement agreement between Otsuka and Akebia.
Specifically, license, collaboration and other revenue in the
second quarter of 2022 included a nonrefundable and non-creditable
termination and settlement payment of $55.0
million that Otsuka paid to Akebia in July 2022. In addition, Akebia recognized
$15.5 million related to previously
deferred revenue and $9.6 million of
non-cash consideration related to Otsuka's obligations to complete
certain agreed upon clinical activities in the second quarter of
2022. This decrease was partially offset by a $10.0 million upfront payment as part of license
agreement entered into with Medice in the second quarter of
2023.
- COGS: Cost of goods sold was $17.3 million for the second quarter of 2023
compared to $18.6 million for the
second quarter of 2022. The decrease was primarily due to lower
write-downs of inventory as a result of excess, obsolescence, scrap
or other reasons charged to costs of goods sold in the second
quarter of 2023. Akebia continues to incur a non-cash amortization
expense related to the intangible asset of $9.0 million per quarter through the fourth
quarter of 2024.
- R&D Expenses: Research and development
expenses were $20.2 million for the
second quarter of 2023 compared to $26.0
million for the second quarter of 2022. The decrease was
primarily due to a reduction in spending on vadadustat development,
including decreased clinical trial costs. In addition, Akebia
decreased the overall R&D headcount related costs as a result
of the April 2022 reduction in force
and decreased outsourced contract services.
- SG&A Expenses: Selling, general and
administrative expenses were $27.0
million for the second quarter of 2023 compared to
$32.2 million for the second quarter
of 2022. The decrease was primarily due to decreased headcount
related costs as a result of the April and November 2022 reductions in force. In addition,
Akebia decreased Auryxia marketing, promotional expenses and
professional service costs.
- Net Loss: Net loss was $11.2
million for the second quarter of 2023 compared to net
income of $29.4 million for the
second quarter of 2022. The net loss is primarily a result of lower
license, collaboration and other revenue due to the second quarter
of 2022 benefiting from the $55.0
million termination fee from Otsuka noted above. In the
second quarter of 2023 Akebia continued to implement further cost
saving initiatives and operate more efficiently with significantly
lower headcount as a result of the reductions in force that
occurred in April and November
2022.
- Cash Position: Cash and cash equivalents as of
June 30, 2023, were approximately
$53.6 million. Akebia expects to fund
its current operating plan with existing cash resources and cash
from operations for at least the next twelve months.
Revisions to Prior Period Financial Results
Through the course of preparing its financial statements for the
quarter ended June 30, 2023, Akebia
identified certain accounting errors related to the recording and
reporting of accrued product returns for Auryxia (Product Return
Reserves Errors) and, as a result, identified a material weakness
in its internal controls over financial reporting as of
December 31, 2022 and through
June 30, 2023. The amendment to
Akebia's 2022 annual report that the company intends to file will
reflect revisions to its financial statements for the fiscal years
ended December 31, 2022, 2021 and
2020 to correct the Product Return Reserves Errors, which primarily
impact the balance sheet in those years and to correct certain
other adjustments in those periods.
The Product Return Reserves Errors resulted in an under accrual
of liabilities of $8.2 million,
$7.9 million and $6.0 million for the years ended December 31, 2022, 2021 and 2020, respectively.
In addition, accounts receivable was understated by $1.1 million, $0.7
million and $0.7 million, for
the years ended December 31, 2022,
2021 and 2020, respectively, and goodwill was understated by
$2.6 million for the years ended
December 31, 2022, 2021 and 2020.
Additional immaterial adjustments have been made to the prior year
financial statements. Included at the end of this release are
tables identifying the impacts of the revision on the Company's
unaudited condensed consolidated financial statements as of and for
the three and six months ended June 30,
2022 and the three months ended March
31, 2023 and 2022, respectively.
Conference Call
Akebia will host a conference call on Friday, August 25 at 9:00
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 then you will be provided with dial in
details. To avoid delays, we encourage dialing into the conference
call fifteen 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
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 will be available via SwissMedic
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 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 filing of an
amendment to its Annual Report on Form 10-K for the year ended
December 31, 2022; Akebia's
expectations and plans with respect to the resubmission of its NDA
for vadadustat, including the timing thereof; Akebia's expectations
regarding the timing for a decision by the FDA on its NDA for
vadadustat once resubmitted; Akebia's expectations on the timing
for certain regulatory decisions for vadadustat by regulatory
authorities in Australia; Akebia's
plans and expectations with respect to commercializing Vafseo in
Europe, including the timing
thereof; 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 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," "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 resubmission of
the NDA 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®, Auryxia® (ferric
citrate) and Vafseo® (vadadustat) are registered
trademarks of Akebia Therapeutics, Inc. and its affiliates.
Akebia Therapeutics Contact
Mercedes Carrasco
mcarrasco@akebia.com
AKEBIA THERAPEUTICS,
INC.
|
Unaudited
Consolidated Statements of Operations
|
(in thousands,
except per share data)
|
|
|
Three Months Ended
June 30,
|
|
2023
|
|
2022
|
Revenues
|
|
|
|
Product revenue,
net
|
$
42,244
|
|
$
43,309
|
License, collaboration
and other revenue
|
14,132
|
|
83,056
|
Total
revenues
|
56,376
|
|
126,365
|
Cost of goods
sold
|
|
|
|
Product
|
8,273
|
|
9,589
|
Amortization of
intangible asset
|
9,011
|
|
9,011
|
Total cost of goods
sold
|
17,284
|
|
18,600
|
Operating
expenses
|
|
|
|
Research and
development
|
20,197
|
|
26,027
|
Selling, general and
administrative
|
27,036
|
|
32,240
|
License
expense
|
949
|
|
892
|
Restructuring
|
(94)
|
|
14,531
|
Total operating
expenses
|
48,088
|
|
73,690
|
Operating (loss)
income
|
(8,996)
|
|
34,075
|
Other expense,
net
|
(1,652)
|
|
(4,626)
|
Loss on lease
termination
|
(524)
|
|
—
|
Net (loss)
income
|
$
(11,172)
|
|
$
29,449
|
Net (loss) income per
share - basic
|
$
(0.06)
|
|
$
0.16
|
Weighted-average number
of common shares - basic
|
186,817
|
|
183,598
|
Net (loss) income per
share - diluted
|
$
(0.06)
|
|
$
0.15
|
Weighted-average number
of common shares - diluted
|
186,817
|
|
190,375
|
Unaudited Selected
Balance Sheet Data
|
(in
thousands)
|
|
|
June 30,
2023
|
|
December 31,
2022
|
Cash and cash
equivalents
|
$
53,572
|
|
$
90,466
|
Working
capital
|
26,263
|
|
55,646
|
Total assets
|
253,712
|
|
356,054
|
Total stockholders'
equity
|
(26,807)
|
|
5,230
|
The following tables reflect the impact of the revision on the
Company's condensed consolidated financial statements as of and for
the three and six months ended June 30,
2022. Only the individual lines previously reported that are
impacted by the Product Return Reserve Errors as well as the
correction of other immaterial misstatements to the financial
statements are shown below (dollars in thousands, except per
share amount):
|
|
June 30,
2022
|
Unaudited Condensed
Consolidated Balance Sheet
|
|
As Previously
Reported
|
|
Adjustment
|
|
As
Revised
|
Inventories
|
|
$
36,272
|
|
$
3,954
|
|
$
40,226
|
Accounts receivable,
net
|
|
81,869
|
|
133
|
|
82,002
|
Total current
assets
|
|
304,163
|
|
4,087
|
|
308,250
|
Goodwill
|
|
55,053
|
|
3,991
|
|
59,044
|
Total assets
|
|
521,804
|
|
8,078
|
|
529,882
|
Accrued expenses and
other current liabilities
|
|
91,284
|
|
3,721
|
|
95,005
|
Total current
liabilities
|
|
233,680
|
|
3,721
|
|
237,401
|
Other non-current
liabilities
|
|
66,889
|
|
7,721
|
|
74,610
|
Total
liabilities
|
|
459,504
|
|
11,442
|
|
470,946
|
Accumulated
deficit
|
|
(1,493,496)
|
|
(3,363)
|
|
(1,496,859)
|
Total liabilities and
stockholders' equity
|
|
$
521,804
|
|
$
8,078
|
|
$
529,882
|
Unaudited Condensed
Consolidated Statement
of Operations and
Comprehensive Income
|
|
Three Months Ended
June 30, 2022
|
|
As Previously
Reported
|
|
Adjustment
|
|
As
Revised
|
Product revenue,
net
|
|
$
43,703
|
|
$
(394)
|
|
$
43,309
|
Selling, general and
administrative
|
|
32,807
|
|
(567)
|
|
32,240
|
Operating
income
|
|
33,902
|
|
173
|
|
34,075
|
Net income and
comprehensive income
|
|
$
29,276
|
|
$
173
|
|
$
29,449
|
Earnings per share -
basic
|
|
$
0.16
|
|
$
—
|
|
$
0.16
|
Earnings per share -
diluted
|
|
$
0.15
|
|
$
—
|
|
$
0.15
|
|
|
Six Months Ended
June 30, 2022
|
Unaudited Condensed
Consolidated Statement of
Operations and
Comprehensive Income
|
|
As Previously
Reported
|
|
Adjustment
|
|
As
Revised
|
Product revenue,
net
|
|
$
85,151
|
|
$
(470)
|
|
$
84,681
|
Cost of goods sold,
product
|
|
31,923
|
|
771
|
|
32,694
|
Selling, general and
administrative
|
|
77,134
|
|
(328)
|
|
76,806
|
Operating
loss
|
|
(24,591)
|
|
(913)
|
|
(25,504)
|
Net loss and
comprehensive loss
|
|
$
(33,145)
|
|
$
(913)
|
|
$
(34,058)
|
Net loss per share -
basic and diluted
|
|
$
(0.18)
|
|
$
(0.01)
|
|
$
(0.19)
|
The following tables reflect the impact of the revision on the
Company's condensed consolidated financial statements as of and for
the three months ended March 31, 2023
and 2022. Only the individual lines previously reported that are
impacted by the Product Return Reserve Errors as well as the
correction of other immaterial misstatements to the financial
statements are shown below (dollars in thousands, except per
share amount):
|
March 31,
2023
|
Unaudited Condensed
Consolidated Balance Sheet
|
As Previously
Reported
|
|
Adjustment
|
|
As
Revised
|
Inventories
|
$
20,604
|
|
$
(194)
|
|
$
20,410
|
Accounts receivable,
net
|
17,781
|
|
950
|
|
18,731
|
Prepaid expenses and
other current assets
|
25,381
|
|
(678)
|
|
24,703
|
Total current
assets
|
120,719
|
|
79
|
|
120,798
|
Goodwill
|
55,053
|
|
3,991
|
|
59,044
|
Total assets
|
276,858
|
|
4,070
|
|
280,928
|
Accrued expenses and
other current liabilities
|
46,367
|
|
4,712
|
|
51,079
|
Total current
liabilities
|
82,944
|
|
4,712
|
|
87,656
|
Other non-current
liabilities
|
12,643
|
|
4,129
|
|
16,772
|
Total
liabilities
|
291,210
|
|
8,841
|
|
300,051
|
Accumulated
deficit
|
(1,579,130)
|
|
(4,772)
|
|
(1,583,902)
|
Total liabilities and
stockholders' equity
|
$
276,858
|
|
$
4,070
|
|
$
280,928
|
|
Three Months Ended
March 31, 2023
|
Unaudited Condensed
Consolidated Statement of
Operations and
Comprehensive Income
|
As Previously
Reported
|
|
Adjustment
|
|
As
Revised
|
Product revenue,
net
|
$
34,828
|
|
$
(122)
|
|
$
34,706
|
Cost of goods sold,
product
|
10,473
|
|
705
|
|
11,178
|
Selling, general and
administrative
|
25,221
|
|
(168)
|
|
25,053
|
Operating
loss
|
(24,938)
|
|
(659)
|
|
(25,597)
|
Net loss and
comprehensive loss
|
$
(26,217)
|
|
$
(659)
|
|
$
(26,876)
|
Earnings per share -
basic and diluted
|
$
(0.14)
|
|
$
(0.01)
|
|
$
(0.15)
|
|
March 31,
2022
|
Unaudited Condensed
Consolidated Balance Sheet
|
As Previously
Reported
|
|
Adjustment
|
|
As
Revised
|
Inventories
|
$
39,422
|
|
$
1,676
|
|
$
41,098
|
Accounts receivable,
net
|
64,582
|
|
776
|
|
65,358
|
Total current
assets
|
302,687
|
|
2,452
|
|
305,139
|
Goodwill
|
55,053
|
|
3,991
|
|
59,044
|
Total assets
|
535,356
|
|
6,443
|
|
541,799
|
Accrued expenses and
other current liabilities
|
109,660
|
|
4,583
|
|
114,243
|
Total current
liabilities
|
253,914
|
|
4,583
|
|
258,497
|
Other non-current
liabilities
|
77,743
|
|
5,398
|
|
83,141
|
Total
liabilities
|
509,240
|
|
9,981
|
|
519,221
|
Accumulated
deficit
|
(1,522,772)
|
|
(3,537)
|
|
(1,526,309)
|
Total liabilities and
stockholders' equity
|
$
535,356
|
|
$
6,443
|
|
$
541,799
|
|
Three Months Ended
March 31, 2022
|
Unaudited Condensed
Consolidated Statement of
Operations and
Comprehensive Income
|
As Previously
Reported
|
|
Adjustment
|
|
As
Revised
|
Product revenue,
net
|
$
41,448
|
|
$
(76)
|
|
$
41,372
|
Cost of goods sold,
product
|
22,333
|
|
772
|
|
23,105
|
Selling, general and
administrative
|
44,327
|
|
239
|
|
44,566
|
Operating
loss
|
(58,493)
|
|
(1,088)
|
|
(59,581)
|
Net loss and
comprehensive loss
|
$
(62,421)
|
|
$
(1,088)
|
|
$
(63,509)
|
Earnings per share -
basic and diluted
|
$
(0.35)
|
|
$
—
|
|
$
(0.35)
|
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SOURCE Akebia Therapeutics