CAMBRIDGE, Mass., May 10, 2021 /PRNewswire/ -- Akebia
Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical
company with the purpose of bettering the lives of people impacted
by kidney disease, today reported financial results for the first
quarter ended March 31, 2021 and
highlighted recent corporate milestones. The Company will host a
conference call today, Monday, May 10,
2021, at 9:00 a.m. Eastern
Time.
"Akebia is off to a great start in 2021, building positive
momentum with solid execution on strategic priorities that set the
stage for an exciting year. Most importantly, we submitted the
vadadustat NDA to the FDA, a significant milestone for Akebia and
our partner, Otsuka Pharmaceutical Co. Ltd. We are also very proud
that the New England Journal of Medicine recently published
the results from both INNO2VATE and PRO2TECT,
the global Phase 3 programs for vadadustat. We believe these
publications reinforce the scientific rigor and quality of the
vadadustat clinical development program, and we are pleased with
early feedback from the medical community," stated John P. Butler, Chief Executive Officer of
Akebia. "We believe this progress positions us well to continue
advancing vadadustat with the goal of bringing this novel
therapeutic to patients as quickly as possible, subject to
regulatory approval. We remain confident in the clarity and quality
of our data, and we look forward to engaging with the FDA on our
NDA. In addition, we are working with Otsuka on the preparation of
a Marketing Authorization Application (MAA) for vadadustat for
submission to the European Medicines Agency (EMA), expected this
year."
Recent Business Highlights:
- In April, the New England Journal of Medicine (NEJM)
published the results of Akebia's global Phase 3 program for
vadadustat, which consisted of two programs that evaluated the
efficacy and safety of vadadustat versus darbepoetin alfa for the
treatment of anemia due to CKD in adult patients on dialysis
(INNO2VATE) and not on dialysis
(PRO2TECT).
- In March, Akebia submitted an NDA to the FDA for vadadustat for
the treatment of anemia due to CKD in both adult patients on
dialysis and adult patients not on dialysis.
- In February, Akebia completed a non-dilutive transaction with
an entity managed by HealthCare Royalty Management, LLC (HCR), to
monetize the Company's rights to receive royalties and sales
milestones on vadadustat net sales under its collaboration
agreement with Mitsubishi Tanabe Pharma Corporation (MTPC), with an
upfront payment of $45 million.
- In February, Akebia announced that LeAnne M. Zumwalt joined Akebia's Board of
Directors. Ms. Zumwalt recently served as Group Vice President,
Government Affairs at DaVita Inc.
- In February, Akebia launched its Medical Engagement Hub,
an online resource dedicated to scientific education and connecting
U.S. healthcare professionals with Akebia Medical Affairs.
- In January, the University of Texas Health
Science Center at Houston (UTHealth) in Houston, Texas, announced that it had received
$5.1 million in government funding
for its study evaluating the use of vadadustat as a potential
therapy to prevent and lessen the severity of acute respiratory
distress syndrome (ARDS), a complication of COVID-19. This
investigator-sponsored research study is currently underway and
actively enrolling patients.
First Quarter Financial Results
- Revenues: Total revenue was $52.3
million for the first quarter of 2021 compared to
$88.5 million for the first quarter
of 2020. The decrease compared to the same period in 2020 was
primarily due to lower collaboration revenue consistent with the
Company successfully completing the INNO2VATE and
PRO2TECT global Phase 3 clinical programs.
-
- Collaboration revenue was $21.9
million for the first quarter of 2021 compared to
$59.3 million for the first quarter
of 2020.
- Net product revenue was $30.4
million for the first quarter of 2021 compared with
$29.2 million for the first quarter
of 2020, an increase of 4 percent.
- COGS: Cost of goods sold was $34.6 million for the first quarter of 2021
compared to $27.7 million for the
first quarter of 2020. The increase was driven by higher non-cash
purchase accounting adjustments as a result of the merger with
Keryx, and a $5.1 million non-cash
charge to inventory reserves related to a previously disclosed
manufacturing quality issue related to Auryxia® (ferric
citrate), partially offset by an $8.9
million non-cash gain due to a reduction to the liability
for excess purchase commitments primarily as a result of the
Company having successfully modified certain supply
agreements.
- R&D Expenses: Research and development expenses were
$40.6 million for the first quarter
of 2021 compared to $81.2 million for
the first quarter of 2020. The decrease compared to the same period
in 2020 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 $41.3 million for the
first quarter of 2021 compared to $38.0
million for the first quarter of 2020.
- Net Loss: Net loss was $69.6
million for the first quarter of 2021 compared to
$60.7 million for the first quarter
of 2020. The increase in net loss compared to the prior year period
was due primarily to lower collaboration revenue and higher cost of
goods sold, partially offset by lower operating expenses.
- Cash Position: Cash, cash equivalents and
available-for-sale securities as of March
31, 2021 were $272.8 million.
The Company expects its cash resources to fund its current
operating plan beyond the expected U.S. launch of vadadustat,
assuming timely regulatory approval and the receipt of associated
regulatory milestones.
"Despite the ongoing impact of COVID-19 on dialysis patients, we
are encouraged by Auryxia's revenue growth in the first quarter of
2021 when compared to the prior year's period. We believe this
performance highlights Auryxia's favorable product profile and the
critical nature of this therapy, as well as our team's ability to
execute at a high level," stated David A.
Spellman, Chief Financial Officer of Akebia. "While we
remain cautious due to COVID-19, together with our continued
commercial efforts, we believe that Auryxia's positioning will
drive product revenue growth for the year."
Conference Call
Akebia will host a conference call at 9:00 a.m. Eastern Time today, Monday, May 10, to discuss its first 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 6250159.
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 May 16, 2021. To
access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406
(international) and reference conference ID number 6250159. 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 an oral hypoxia-inducible factor prolyl
hydroxylase (HIF-PH) 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
recently completed its global Phase 3 development program for the
treatment of anemia due to CKD. Vadadustat is not approved by the
U.S. Food and Drug Administration (FDA) or any other regulatory
authority with the exception of Japan's Ministry of Health, Labour and Welfare
(MHLW). 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 connection between
the publication of results INNO2VATE and
PRO2TECT in the New England Journal of Medicine and
vadadustat's clinical development program; the commercialization of
vadadustat, if approved, and the timing thereof; the timing of
submission of an MAA for vadadustat to EMA; the potential impact of
COVID-19; the potential for product revenue growth in 2021;
and the timing and expectations for the Company's cash runway in
relation to the expected timing of the U.S. launch of vadadustat,
assuming timely regulatory approval and the receipt of associated
regulatory milestones.. The terms "believe," "confident," "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 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
candidates, including vadadustat; the direct or indirect impact of
the COVID-19 pandemic on our business, operations, and the markets
and communities in which the Company 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 and preclinical 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, and to operate the
Company; the risks associated with potential generic entrants for
Akebia's commercial product and vadadustat, if approved; 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 Akebia's commercial
product and vadadustat, if approved; 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 commercial product, vadadustat and any other
product candidates. Other risks and uncertainties include those
identified under the heading "Risk Factors" in Akebia's Annual
Report on Form 10-K for the year ended December 31, 2020 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.
Contact:
Kristen K. Sheppard, Esq.
IR@akebia.com
AKEBIA
THERAPEUTICS, INC.
|
Consolidated
Statements of Operations
|
(in thousands,
except share and per share data)
|
(unaudited)
|
|
Three Months
Ended
|
|
March 31,
2021
|
|
March 31,
2020
|
|
|
|
|
Revenues:
|
|
|
|
Product revenue,
net
|
$
|
30,408
|
|
|
$
|
29,209
|
|
License, collaboration
and other revenue
|
21,896
|
|
|
59,269
|
|
Total
revenues
|
52,304
|
|
|
88,478
|
|
Cost of goods
sold:
|
|
|
|
Product
|
25,595
|
|
|
18,613
|
|
Amortization of
intangibles
|
9,011
|
|
|
9,100
|
|
Impairment of
intangible asset
|
—
|
|
|
—
|
|
Total cost of goods
sold
|
34,606
|
|
|
27,713
|
|
Operating
expenses:
|
|
|
|
Research and
development
|
40,611
|
|
|
81,231
|
|
Selling, general and
administrative
|
41,328
|
|
|
37,983
|
|
License
expense
|
695
|
|
|
676
|
|
Total operating
expenses
|
82,634
|
|
|
119,890
|
|
Operating
loss
|
(64,936)
|
|
|
(59,125)
|
|
Other expense,
net
|
(4,644)
|
|
|
(1,622)
|
|
Net loss
|
$
|
(69,580)
|
|
|
$
|
(60,747)
|
|
Net loss per share -
basic and diluted
|
$
|
(0.45)
|
|
|
$
|
(0.47)
|
|
Weighted-average
number of common shares - basic and diluted
|
153,820,809
|
|
128,395,163
|
AKEBIA
THERAPEUTICS, INC.
|
Selected Balance
Sheet Data
|
(in
thousands)
|
(unaudited)
|
|
March 31,
2021
|
|
December 31,
2020
|
Cash, cash
equivalents and available for sale securities
|
$272,764
|
|
$268,690
|
Working
capital
|
192,338
|
|
184,291
|
Total
assets
|
628,703
|
|
644,139
|
Total stockholders'
equity
|
213,891
|
|
247,618
|
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SOURCE Akebia Therapeutics