CAMBRIDGE, Mass., Feb. 25, 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 fourth quarter
and full-year ended December 31, 2020
and provided business updates. The Company will host a conference
call today, Thursday, February 25,
2021, at 9:00 a.m. Eastern
Time.
Akebia also announced a $60
million 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). MTPC has the exclusive rights to
commercialize vadadustat in Japan,
where it is currently marketed under the trade name Vafseo™
(vadadustat), and certain other Asian countries. Under
the terms of the agreement with HCR, Akebia receives an upfront
cash payment of $45 million and is
eligible to receive an additional $15
million if certain sales milestones are achieved. In
exchange, HCR has the right to receive Vafseo royalties and sales
milestones due to the Company under its collaboration agreement
with MTPC, subject to an annual cap of $13
million and an aggregate cap of $150
million. After the annual cap is met in a given calendar
year, Akebia will recognize 85 percent of Vafseo royalties and
sales milestones from MTPC for that year. After the aggregate cap
is met, Akebia will recognize 100 percent of Vafseo royalties and
sales milestones until this revenue stream ends under the terms of
the Company's collaboration agreement with MTPC. The transaction
does not include potential future regulatory milestones to be paid
by MTPC.
"2020 was a year of focused execution for Akebia as we advanced
vadadustat, our investigational oral hypoxia-inducible factor
prolyl hydroxylase inhibitor (HIF-PHI), and executed on our
commercial priorities. Importantly, we achieved this while
continuing to provide patients with access to our therapies and
keeping with our goal of maintaining a strong balance sheet,"
stated John P. Butler, Chief
Executive Officer of Akebia. "With this forward momentum, we have
line of sight to significant milestones in 2021, including our NDA
submission for vadadustat for the treatment of anemia due to
chronic kidney disease (CKD) in both adult patients on dialysis and
not on dialysis expected by the middle of the second quarter of
this year."
Butler continued, "As we advance vadadustat toward
commercialization, subject to approval, we continue to execute on
key commercial, development, and financial priorities. As dialysis
is a primary focus, we're thrilled to have recently added
LeAnne Zumwalt to our Board of
Directors. LeAnne's perspective and extensive operating experience
with one of the largest dialysis operators in the U.S. will help
ensure that our market and commercial strategies are well aligned
with the needs of dialysis providers and their patients. We're also
pleased to have announced a $60
million royalty monetization transaction with HCR that we
believe strengthens our balance sheet and helps preserve both our
strategic and financial flexibility while we continue investing for
the successful launch of vadadustat, upon approval."
Akebia plans to submit a New Drug Application (NDA) to the U.S.
Food and Drug Administration (FDA) for vadadustat by the middle of
the second quarter of this year for the treatment of anemia due to
CKD in both adult patients on dialysis and adult patients not on
dialysis. In addition, Akebia and its collaborator, Otsuka
Pharmaceutical Co. Ltd. (Otsuka), are working in close
collaboration to prepare a Marketing Authorization Application
(MAA) for submission to the European Medicines Agency (EMA),
expected this year.
Recent Business Highlights:
- In February, the Company 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.
- In November, the study design and methodology for Akebia's
global Phase 3 INNO2VATE program was published in
Nephrology Dialysis Transplantation (NDT).
- In October, the study design and methodology for Akebia's
global Phase 3 PRO2TECT program was published in
American Heart Journal.
- In October, Akebia completed a pre-NDA meeting with the FDA for
vadadustat.
- In October, top-line data from both INNO2VATE and
PRO2TECT were presented at American Society of
Nephrology Kidney Week 2020 Reimagined.
- In October, Akebia and Otsuka launched Balancing Anemia Due
to CKD, a campaign and website designed to increase awareness
and education of anemia due to CKD among healthcare providers with
the goal of improving the management of this disease for
patients.
Fourth Quarter and Full-Year 2020 Financial Results
- Revenues: Total revenue was $56.7
million for the fourth quarter of 2020 compared to
$69.6 million for the fourth quarter
of 2019, and $295.3 million for the
full-year 2020 compared to $335.0
million for the full-year 2019. The decline in both periods
was driven by lower collaboration revenue consistent with the
Company successfully completing its global Phase 3 clinical
development 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).
-
- Collaboration revenue was $22.1
million for the fourth quarter of 2020 compared to
$40.6 million for the fourth quarter
of 2019, and $166.4 million for the
full-year 2020 compared with $223.9
million for the full-year 2019. The change in both periods
is due to the timing of when vadadustat development expenses are
incurred and the associated revenue is recognized on a
percentage-of-completion basis. Collaboration revenue for the
full-year 2020 includes $0.4 million
in royalty revenue related to the commercial sale of Vafseo in
Japan from MTPC, which launched in
August of 2020.
- Net product revenue was $34.6
million for the fourth quarter of 2020 compared with
$28.9 million for the fourth quarter
of 2019, an increase of 20 percent. Net product revenue was
$128.9 million for the full-year 2020
compared to $111.1 million for the
full-year 2019, an increase of 16 percent. While Akebia did not
experience a significant impact from COVID-19 on revenues during
the first nine months of 2020, the Company believes its revenue
growth was negatively impacted during the fourth quarter of 2020
primarily as the kidney patient populations that it serves continue
to experience both higher hospitalization and mortality rates due
to COVID-19.
- COGS: Cost of goods sold was $63.2 million for the fourth quarter of 2020
compared to $38.1 million for the
fourth quarter of 2019. Excluding non-cash purchase accounting
adjustments as a result of the merger with Keryx, the increase in
the fourth quarter of 2020 was primarily driven by a $14.8 million non-cash charge related to excess
purchase commitments. Cost of goods sold was $295.9 million for the full-year 2020, compared
with $145.3 million for the full-year
2019. Cost of goods sold for 2020 includes a $115.5 million non-cash charge related to the
impairment of the Auryxia intangible asset in the second quarter of
2020, a $25.1 million non-cash charge
related to excess purchase commitments, and a $20.1 million non-cash charge for inventory
write-downs largely related to a previously disclosed manufacturing
quality issue related to Auryxia.
- R&D Expenses: Research and development expenses were
$37.6 million for the fourth quarter
of 2020 compared to $80.4 million for
the fourth quarter of 2019, and $218.5
million for the full-year 2020 compared to $323.0 million for the full-year 2019. The
decline in both periods was primarily driven by a decrease in costs
consistent with the Company completing the INNO2VATE and
PRO2TECT studies.
- SG&A Expenses: Selling, general and administrative
expenses were $40.3 million for the
fourth quarter of 2020 compared to $44.9
million for the fourth quarter of 2019, and $153.9 million for the full-year 2020 compared to
$149.5 million for the full-year
2019.
- Net Loss: Net loss was $87.0
million for the fourth quarter of 2020 compared to
$94.5 million for the fourth quarter
of 2019, and $383.5 million for the
full-year 2020 compared to $279.7
million for the full-year 2019. The increase in net loss for
the full-year 2020 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 December
31, 2020 were $268.7 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.
"As COVID-19 continues to adversely and disproportionately
impact our patient population with higher hospitalization and
mortality rates, we expect this will have a negative impact on
future Auryxia revenue growth. While we are unable to fully
quantify the impact of the COVID-19 pandemic on future revenues and
revenue growth, we continue to work to position the Company to
navigate these challenges. As such, our financial priorities remain
focused on improving our cost structure and maintaining a strong
balance sheet, as evidenced by our recent $60 million non-dilutive royalty transaction with
HCR," stated David A. Spellman,
Chief Financial Officer of Akebia
Therapeutics.
Conference Call
Akebia will host a conference call at
9:00 a.m. Eastern Time today,
Thursday, February 25th, to discuss
its fourth quarter and full-year 2020 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 5455117. 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 March 3, 2021. To
access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406
(international) and reference conference ID number 5455117. 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 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 timing of submission
of an NDA to the FDA for vadadustat for the treatment of anemia due
to chronic kidney disease in both adult patients on dialysis and
not on dialysis; the timing of submission of a MAA for submission
to the EMA; the potential for obtaining approval of vadadustat in
dialysis and non-dialysis indications; statements regarding
Akebia's marketing and commercial strategies and Ms.
Zumwalt's ability to ensure alignment of such strategies with
the needs of dialysis providers and their patients; Akebia's
achievement of certain sales milestones and the receipt of cash
payments tied thereto in connection with the non-dilutive royalty
transaction with HCR; the results that the royalty monetization
agreement between Akebia and HCR has on Akebia's balance sheet and
strategic and financial flexibility; the negative impact that
higher hospitalization and mortality rates due to COVID-19 in the
kidney patient populations that the Company serves had on the
Company's revenue growth during the fourth quarter of 2020 and may
continue to have in the future; and the timing and expectations for
the Company's cash runway in relation to the expected timing of the
U.S. launch of vadadustat. 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 related to regulatory filings and approvals, such as
the anticipated timing of filing the NDA to the FDA and MAA to the
EMA for vadadustat and our outlook related thereto; the direct or
indirect impact of the COVID-19 pandemic on Akebia's business,
operations, and the markets and communities in which the Company
and its partners, collaborators, vendors and customers operate; the
potential therapeutic benefits, safety profile and effectiveness of
Akebia's product candidates, including vadadustat; 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 Akebia's
product and product candidates, 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; market acceptance and coverage and
reimbursement of the Company's commercial product and vadadustat,
if approved; the risks associated with potential generic entrants
for Akebia's commercial product and vadadustat, if approved; early
termination of any of Akebia's 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, need for additional capital, financing our future
cash needs, costs, expenses, revenues, capital resources, cash
flows, financial performance, profitability, tax obligations,
liquidity, growth, contractual obligations, our internal control
over financial reporting and disclosure controls and procedures,
and remediation of any material weakness or deficiencies identified
in our internal controls and procedures; and Akebia's intellectual
property position, including its ability to obtain, maintain and
enforce patent and other intellectual property protection for our
commercial product, vadadustat and any other 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 September 30,
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.
Investor 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
|
|
Twelve Months
Ended
|
|
December 31,
2020
|
|
December 31,
2019
|
|
December 31,
2020
|
|
December 31,
2019
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
Product revenue,
net
|
$
|
34,604
|
|
|
$
|
28,915
|
|
|
$
|
128,901
|
|
|
$
|
111,119
|
|
License, collaboration
and other revenue
|
22,095
|
|
|
40,640
|
|
|
166,406
|
|
|
223,882
|
|
Total
revenues
|
56,699
|
|
|
69,555
|
|
|
295,307
|
|
|
335,001
|
|
Cost of goods
sold:
|
|
|
|
|
|
|
|
Product
|
56,026
|
|
|
29,047
|
|
|
148,866
|
|
|
108,935
|
|
Amortization of
intangibles
|
7,208
|
|
|
9,100
|
|
|
31,515
|
|
|
36,401
|
|
Impairment of
intangible asset
|
—
|
|
|
—
|
|
|
115,527
|
|
|
—
|
|
Total cost of goods
sold
|
63,234
|
|
|
38,147
|
|
|
295,908
|
|
|
145,336
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
37,578
|
|
|
80,412
|
|
|
218,485
|
|
|
322,969
|
|
Selling, general and
administrative
|
40,311
|
|
|
44,918
|
|
|
153,947
|
|
|
149,455
|
|
License
expense
|
979
|
|
|
969
|
|
|
3,409
|
|
|
3,529
|
|
Total operating
expenses
|
78,868
|
|
|
126,299
|
|
|
375,841
|
|
|
475,953
|
|
Operating
loss
|
(85,403)
|
|
|
(94,891)
|
|
|
(376,442)
|
|
|
(286,288)
|
|
Other expense,
net
|
(1,597)
|
|
|
(1,344)
|
|
|
(7,015)
|
|
|
(2)
|
|
Net loss before
income taxes
|
(87,000)
|
|
|
(96,235)
|
|
|
(383,457)
|
|
|
(286,290)
|
|
Benefit from income
taxes
|
—
|
|
|
(1,752)
|
|
|
—
|
|
|
(6,631)
|
|
Net loss
|
$
|
(87,000)
|
|
|
$
|
(94,483)
|
|
|
$
|
(383,457)
|
|
|
$
|
(279,659)
|
|
Net loss per share -
basic and diluted
|
$
|
(0.60)
|
|
|
$
|
(0.79)
|
|
|
$
|
(2.77)
|
|
|
$
|
(2.36)
|
|
Weighted-average
number of common shares - basic and diluted
|
145,111,415
|
|
119,358,081
|
|
138,463,152
|
|
118,395,919
|
AKEBIA
THERAPEUTICS, INC.
|
Selected Balance
Sheet Data
|
(in
thousands)
|
(unaudited)
|
|
December 31,
2020
|
|
December 31,
2019
|
Cash, cash
equivalents and available for sale securities
|
$268,690
|
|
$147,694
|
Working
capital
|
184,291
|
|
101,415
|
Total
assets
|
644,139
|
|
771,201
|
Total stockholders'
equity
|
247,618
|
|
394,757
|
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SOURCE Akebia Therapeutics