CAMBRIDGE, Mass., Nov. 4, 2021 /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, 2021 and
highlighted recent corporate milestones.
The Company will host a conference call on Tuesday, November 9, 2021, at 9:00 a.m. Eastern Time. Executives will highlight
publications and scientific presentations of vadadustat Phase 3
clinical data, which will be presented at American Society of
Nephrology Kidney Week 2021 beginning today. The Company will also
discuss ongoing pre-commercialization activities ahead of a
potential first-in-class U.S. launch for vadadustat, Akebia's
investigational oral therapeutic for the treatment of anemia due to
chronic kidney disease (CKD). Vadadustat is currently under review
by the U.S. Food and Drug Administration (FDA) with a scheduled
Prescription Drug User Fee Act (PDUFA) date of March 29, 2022.
"We are within five months of vadadustat's PDUFA date, which has
the potential to be a pivotal catalyst for the company, and, if
approved, would mean the availability of a novel, oral therapeutic
for people living with anemia due to chronic kidney disease," said
John P. Butler, Chief Executive
Officer, Akebia Therapeutics. "We
continue to value opportunities to share vadadustat efficacy and
safety data with nephrologists through scientific congresses such
as ASN Kidney Week. While our review with the FDA is ongoing, we
remain confident that the data we have compiled and submitted for
review makes a compelling case for approval in dialysis
patients."
"Akebia has made substantial progress on pre-commercialization
activities to prepare for a first-in-class product launch for
vadadustat in the U.S. in 2022, subject to regulatory approval,"
added Dell Faulkingham, Chief
Commercial Officer, Akebia
Therapeutics. "As part of our commercialization preparation,
we are focused on broad access initiatives, and are fortunate that,
if approved, our specialized renal sales force will be ready to add
a second product for use in the dialysis market. We are working
closely with our partners at Vifor and Otsuka to ensure we are
well-positioned to execute a successful launch, including
preparedness for reimbursement for vadadustat under Transitional
Drug Add-on Payment Adjustment (TDAPA) for dialysis organizations,
which will be key to our launch."
Recent Business Highlights:
- Akebia announced that Otsuka submitted a marketing
authorization application to the European Medicines Agency for
vadadustat for the treatment of anemia due to CKD in adults.
- Vadadustat efficacy and safety data is being presented at the
American Society of Nephrology Kidney Week 2021 beginning today,
November 4, 2021. Eleven abstracts
were accepted for presentation at Kidney Week 2021.
- Akebia has settled all patent litigation proceedings related to
Abbreviated New Drug Applications filed with respect to
Auryxia® (ferric citrate) tablets, which allows for
generic versions of Auryxia beginning in March 2025.
- Akebia announced that Ron
Frieson, Chief Operating Officer of Children's Healthcare of
Atlanta (CHOA), joined Akebia's
Board of Directors. Mr. Frieson previously held leadership roles in
external affairs, public policy, and diversity at CHOA, the Atlanta
Urban League and BellSouth Corporation.
Third Quarter Financial Results
- Revenues: Total revenue was $48.8 million for the third quarter of 2021
compared to $60.0 million for
the third quarter of 2020. The decrease compared to the same period
in 2020 was primarily due to lower collaboration revenue from
Otsuka driven by lower development costs incurred subject to cost
share provisions under both the Otsuka U.S. Agreement and the
Otsuka International Agreement as the Company successfully
completed the INNO2VATE and PRO2TECT global
Phase 3 clinical programs and is currently engaged in close-out
activities with respect to the programs. Collaboration
revenue will continue to reflect collaboration development
activities.
-
- Collaboration revenue was $12.0 million for the third quarter of 2021
compared to $25.6 million for
the third quarter of 2020.
- Net product revenue for Auryxia was $36.8 million for the third quarter of 2021
compared to $34.4 million for
the third quarter of 2020, an increase of 7.0% due to lower volume
rebates related to the negative impact to sales volume as a result
of COVID-19, and improved payor mix.
- COGS: Cost of goods sold was $15.9 million for the third quarter of 2021
and included a $6.0 million decrease
to the liability for excess purchase commitments primarily due to
the settlement of all patent litigation proceedings related to
Abbreviated New Drug Applications filed with respect to Auryxia,
which allows for generic versions of Auryxia beginning in
March 2025. Cost of goods sold was
$30.3 million for the third
quarter of 2020 and included $8.4
million in non-cash charges related to the fair-value
inventory step-up from the application of purchase accounting and
$8.5 million primarily related to the
write-down of inventory. These charges for the third quarter of
2020 were partially offset by a $0.7
million reduction to the excess purchase commitments
liability within cost of goods sold.
- R&D Expenses: Research and development expenses
were $40.5 million for the third
quarter of 2021 compared to $46.9 million for the third quarter of 2020.
The decrease compared to the prior year period was primarily due to
the completion of the INNO2VATE and PRO2TECT
global Phase 3 clinical programs.
- SG&A Expenses: Selling, general and
administrative expenses were $46.4 million for the third quarter of 2021
compared to $40.2 million for
the third quarter of 2020. The increase compared to the prior year
period was due primarily to increases in headcount related costs
and one-time legal costs.
- Net Loss: Net loss was $59.5 million for the third quarter of 2021
compared to $60.0 million for
the third quarter of 2020.
- Cash Position: Cash, cash equivalents and
available-for-sale securities as of September 30, 2021, were
$207.2 million. The Company believes
that its cash resources will be sufficient to fund its current
operating plan through at least the next twelve months.
"We continue to be judicious in spend as we invest in
pre-commercialization activities in anticipation of the U.S. launch
of vadadustat in 2022, if approved, while also supporting the
marketing, sales, and payor strategies necessary to continue to
drive Auryxia revenue growth," said David
A. Spellman, Chief Financial Officer, Akebia Therapeutics. "We're proud of the great
work our renal sales and support teams have done to get a critical
therapy to eligible kidney patients, especially in a market that
has seen a decline over the past year due in part to the COVID-19
pandemic."
Conference Call
Akebia will host a conference call on Tuesday, November 9, 2021, at 9:00 a.m. Eastern Time to discuss its third
quarter financial results and recent business highlights. To listen
to the conference call, please dial (877) 458-0977 (domestic) or
(484) 653-6724 (international) using conference ID number 5389484.
The call will also be webcast LIVE and can be accessed via the
Investors section of the Company's website at
http://ir.akebia.com.
A replay of the conference call will be available two hours
after the completion of the call through November 15, 2021. To access the replay, dial
(855) 859-2056 (domestic) or (404) 537-3406 (international) and
reference conference ID number 5389484. An online archive of the
conference call can be accessed via the Investors section of the
Company's website at http://ir.akebia.com.
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. The Company 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 a potential first-in-class 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. The New Drug Application for vadadustat for the treatment
of anemia due to chronic kidney disease (CKD) is under review by
the U.S. Food and Drug Administration (FDA). Vadadustat is an
investigational new drug and is not approved by the FDA or any
regulatory authority with the exception of Japan's Ministry of Health, Labour and
Welfare. In Japan, vadadustat is
approved as a treatment for anemia due to CKD in both
dialysis-dependent and non-dialysis dependent adult patients.
About Anemia due to Chronic Kidney Disease
(CKD)
Anemia is a condition in which a person lacks enough healthy red
blood cells to carry adequate oxygen to the body's tissues. It
commonly occurs in people with CKD because their kidneys do not
produce enough erythropoietin (EPO), a hormone that helps regulate
production of red blood cells. Anemia due to CKD can have a
profound impact on a person's quality of life as it can cause
fatigue, dizziness, shortness of breath and cognitive dysfunction.
Left untreated, anemia leads to deterioration in health and is
associated with increased morbidity and mortality in people with
CKD.
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'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, including,
but not limited to, statements regarding: the anticipated scheduled
PDUFA date for vadadustat and the potential for such date to be a
pivotal catalyst for the Company; vadadustat's potential
first-in-class commercial launch in the U.S., the timing
thereof, and, the Company's preparation related thereto, including
as it relates to Company spend; the potential for vadadustat's
approval by the FDA; Akebia's, including its renal sales force's,
preparation and readiness for launch; vadadustat's potential
positioning as a first-in-class product for the treatment of anemia
due to chronic kidney disease in the U.S.; the market opportunity
for vadadustat; relationships between Auryxia revenue growth and
the Company's support of marketing, sales and payor strategies; and
the Company's expectations with respect to its cash resources and
cash runway.
The terms "believe," "expect," "plan," "potential," "will," and
similar references are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. Each forward-looking statement is subject
to risks and uncertainties that could cause actual results to
differ materially from those expressed or implied in such
statement, including, but not limited to: the timing of any
regulatory filings and approvals; interactions with the FDA,
including reviews and inspections, the timing related thereto and
the outcome thereof; the potential therapeutic benefits, safety
profile and effectiveness of our product and product candidates,
including vadadustat; the direct or indirect impact of the COVID-19
pandemic on our business, operations, and the markets and
communities in which Akebia and its partners, collaborators,
vendors and customers operate; the timing and content of advice
given and decisions made by health authorities, including approval
and labeling decisions; the potential indications, demand and
market potential and acceptance of, as well as coverage and
reimbursement related to, Auryxia and vadadustat, if approved,
including estimates regarding the potential market opportunity for
the Company's product, vadadustat or any other product candidates,
and the size of eligible patient populations; enrollment in
clinical studies; manufacturing, supply and quality risks, and any
recalls, write-downs, impairments or other related consequences or
potential consequences; risks associated with hiring,
training, management and retention and key personnel changes and
transitional periods; the actual funding required to continue to
commercialize Akebia's commercial product, to develop and
commercialize vadadustat or any other product candidates, and to
operate the Company; the risks associated with potential
generic entrants for Akebia's commercial product, vadadustat, if
approved, or any other product candidate; early termination of or
changes to the terms of agreements that Akebia has with any of its
collaborations; Akebia's and its collaborators' ability to satisfy
their obligations under Akebia's collaboration agreements; the
competitive landscape for Auryxia, vadadustat, if approved, and any
other product candidates; the scope, timing, and outcome of any
legal, regulatory and administrative proceedings; changes in the
economic and financial conditions of the businesses of Akebia and
its collaborations partners and vendors; expected reliance on third
parties, including with respect to the development, manufacturing,
supply or commercialization of Akebia's product and product
candidates; the Company's expectations, projections and estimates
regarding its capital requirements; and Akebia's intellectual
property position, including its ability to obtain, maintain and
enforce patent and other intellectual property protection for its
product and product candidates. 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, 2021 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 IR Contact
ir@akebia.com
Akebia Therapeutics Media Contact
Mercedes Carrasco
mcarrasco@akebia.com
AKEBIA
THERAPEUTICS, INC.
|
Consolidated
Statements of Operations
|
(in thousands,
except share and per share data)
|
(unaudited)
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
September 30,
2021
|
|
September 30,
2020
|
|
September 30,
2021
|
|
September 30,
2020
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
Product revenue,
net
|
$
|
36,753
|
|
|
$
|
34,392
|
|
|
$
|
100,120
|
|
|
$
|
94,297
|
|
License, collaboration
and other revenue
|
12,003
|
|
|
25,596
|
|
|
53,853
|
|
|
144,311
|
|
Total
revenues
|
48,756
|
|
|
59,988
|
|
|
153,973
|
|
|
238,608
|
|
Cost of goods
sold:
|
|
|
|
|
|
|
|
Product
|
6,933
|
|
|
24,239
|
|
|
76,012
|
|
|
92,840
|
|
Amortization of
intangibles
|
9,011
|
|
|
6,106
|
|
|
27,032
|
|
|
24,307
|
|
Impairment of
intangible asset
|
—
|
|
|
—
|
|
|
—
|
|
|
115,527
|
|
Total cost of goods
sold
|
15,944
|
|
|
30,345
|
|
|
103,044
|
|
|
232,674
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
40,471
|
|
|
46,857
|
|
|
118,296
|
|
|
180,907
|
|
Selling, general and
administrative
|
46,357
|
|
|
40,171
|
|
|
129,336
|
|
|
113,636
|
|
License
expense
|
870
|
|
|
710
|
|
|
2,460
|
|
|
2,430
|
|
Total operating
expenses
|
87,698
|
|
|
87,738
|
|
|
250,092
|
|
|
296,973
|
|
Operating
loss
|
(54,886)
|
|
|
(58,095)
|
|
|
(199,163)
|
|
|
(291,039)
|
|
Other expense,
net
|
(4,658)
|
|
|
(1,864)
|
|
|
(12,999)
|
|
|
(5,418)
|
|
Net loss
|
$
|
(59,544)
|
|
|
$
|
(59,959)
|
|
|
$
|
(212,162)
|
|
|
$
|
(296,457)
|
|
Net loss per share -
basic and diluted
|
$
|
(0.34)
|
|
|
$
|
(0.42)
|
|
|
$
|
(1.30)
|
|
|
$
|
(2.18)
|
|
Weighted-average
number of common shares - basic and diluted
|
173,782,151
|
|
143,314,729
|
|
163,050,769
|
|
136,230,889
|
AKEBIA
THERAPEUTICS, INC.
|
Selected Balance
Sheet Data
|
(in
thousands)
|
(unaudited)
|
|
September 30,
2021
|
|
December 31,
2020
|
Cash, cash
equivalents and available for sale securities
|
$207,204
|
|
$268,690
|
Working
capital
|
140,879
|
|
184,291
|
Total
assets
|
602,267
|
|
644,139
|
Total stockholders'
equity
|
137,150
|
|
247,618
|
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SOURCE Akebia Therapeutics