- Net Product Revenue for Auryxia
Increases to $23.1 Million for Q1’FY19, Up 12.1% from Q1’FY18;
- Full Enrollment of Phase 3
INNO2VATE Studies; and
- Additions to Executive Leadership Team
to Support Commercial and Clinical Operations.
Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical
company focused on the development and commercialization of
therapeutics for patients with kidney disease, today reported
financial results for the first quarter ended March 31, 2019.
The company also announced full enrollment of its global Phase 3
INNO2VATE studies for vadadustat, that it has bolstered its
commercial capabilities with the addition of Dell Faulkingham as
Senior Vice President, Chief Commercial Officer, and appointed
Steven K. Burke, M.D., as Senior Vice President, Chief Medical
Officer.
“The first quarter marked the achievement of another important
milestone for Akebia with the announcement of positive top-line
results from two Phase 3, active-controlled, pivotal studies
evaluating vadadustat in Japanese patients with anemia due to
chronic kidney disease (CKD),” stated John P. Butler, President and
Chief Executive Officer of Akebia Therapeutics. “We are excited by
these results as they increase our level of confidence in the
hypoxia inducible factor (HIF) pathway and more specifically, the
direction of our clinical program for vadadustat. These results are
expected to serve as the basis for a New Drug Application in Japan
(JNDA) by our collaboration partner, Mitsubishi Tanabe Pharma
Corporation (MTPC), in 2019.”
Butler continued, “We are also pleased to announce the
completion of enrollment in our global Phase 3 INNO2VATE studies
evaluating vadadustat for the treatment of anemia due to CKD in
dialysis-dependent CKD subjects. With the addition of Dell
Faulkingham to our executive team, we have strengthened our
commercial capabilities and believe we are well positioned to
execute on our revenue growth strategies for Auryxia. Lastly, we
look forward to welcoming Dr. Steven Burke as our new Chief Medical
Officer as we continue to execute on the multiple catalysts
expected with vadadustat’s Phase 3 program over the next 12 to 18
months.”
Auryxia Highlights
- Auryxia net product revenue for the
first quarter of 2019 was $23.1 million, representing 12.1 percent
growth over the first quarter of 2018.
- Total Auryxia prescriptions were
40,080, representing 22.5 percent growth over the first quarter of
2018.
Vadadustat Highlights
- Announced positive top-line results
from two Phase 3, active-controlled, pivotal studies evaluating
vadadustat in Japanese subjects with anemia due to CKD in March
2019. Data from these two pivotal studies as well as from two
additional single-arm studies in peritoneal dialysis and
hemodialysis subjects, also recently announced, are expected to
serve as the basis for a JNDA submission by MTPC in 2019.
- Expanded license agreement with Vifor
Pharma announced in April 2019 creates opportunity for accelerated
introduction of vadadustat, if approved by the U.S. Food and Drug
Administration (FDA), in up to 60 percent of U.S. dialysis
patients.
- Enrollment in the global Phase 3
INNO2VATE studies evaluating the safety and efficacy of vadadustat
in dialysis-dependent CKD subjects with anemia due to CKD, has been
completed. Enrollment in the smaller of the
two INNO2VATE studies (the “Correction Study”), was
completed in April 2019, with a total of 369 subjects enrolled.
Enrollment in the larger INNO2VATE study (the “Conversion
Study”) was completed in February 2019, with a total of 3,554
subjects enrolled. The company continues to expect to report
top-line data from both INNO2VATE studies in the second
quarter of 2020, subject to the accrual of major adverse
cardiovascular events (MACE).
- The company expects enrollment in the
global Phase 3 PRO2TECT studies evaluating the safety and efficacy
of vadadustat in non-dialysis dependent CKD subjects with anemia
due to CKD, to be completed in 2019, with up to approximately 3,700
subjects expected to be enrolled. The company continues to expect
to report top-line results in mid-2020, subject to the accrual of
MACE.
Financial ResultsTotal revenue for the first quarter of
2019 was $72.7 million, compared to $45.9 million in the first
quarter of 2018.
Auryxia net product revenue for the first quarter of 2019 was
$23.1 million, compared to $20.6 million, as reported by Keryx
Biopharmaceuticals, Inc. (“Keryx”) prior to its merger with the
company, during the same period in 2018. This represents a 12.1
percent increase in net product revenue from the first quarter of
2018. Auryxia is the company’s FDA approved oral iron tablet to
treat non-dialysis dependent adult CKD patients for iron deficiency
anemia (IDA) and dialysis-dependent adult CKD patients for
hyperphosphatemia.
“As we previously discussed, the Centers for Medicare &
Medicaid Services’ (CMS) new prior authorization requirement for
Auryxia caused delays in approvals of prescriptions and negatively
impacted Auryxia product revenue for the first quarter. We believe
our efforts to help patients and prescribers navigate this process
are working and we’re encouraged with the growth in weekly
prescriptions that we are now seeing. In fact, the prescription
demand we’ve seen in the first four weeks of the second quarter
exceeded the first four weeks of any quarter since Auryxia was
launched,” stated Butler. “Looking ahead, we believe continued
execution on our growth strategy and underlying market demand, will
drive increased revenue for Auryxia in the second quarter and
across the year.”
Collaboration revenue for the first quarter of 2019 was $49.6
million, compared with $45.9 million in the first quarter of 2018.
The increase was primarily due to increased collaboration revenue
in the first quarter of 2019 from the company’s cost sharing
arrangement under its Otsuka collaboration agreements. The company
expects Otsuka to begin funding 80 percent of its development costs
for vadadustat in the second quarter of 2019.
Cost of goods sold was $31.3 million for the first quarter of
2019, consisting of $7.6 million of costs associated with the
manufacture of Auryxia and $23.7 million related to the application
of purchase accounting as a result of the merger with Keryx,
including $14.6 million of inventory step-up and $9.1 million of
amortization of intangibles.
Research and development expenses were $82.4 million for the
first quarter of 2019 compared to $61.4 million for the first
quarter of 2018. The increase was primarily attributable to an
increase in external costs related to the continued advancement of
the PRO2TECT and INNO2VATE Phase 3 studies.
Selling, general and administrative expenses were $34.3 million
for the first quarter of 2019 compared to $9.0 million for the
first quarter of 2018. The increase in selling, general and
administrative expenses was primarily attributable to
commercialization costs associated with Auryxia, as there were no
comparable commercialization costs in the first quarter of
2018.
The company reported a net loss for the first quarter of 2019 of
$72.4 million, or ($0.62) per share, as compared to a net loss of
$23.4 million, or ($0.48) per share, for the first quarter of 2018.
The company’s net loss for the first quarter of 2019 includes the
impact of merger-related accounting charges totaling $23.7 million,
offset by a $2.8 million deferred tax benefit.
The company ended the quarter with cash, cash equivalents and
available-for-sale securities of $168.0 million. The decrease from
the fourth quarter of 2018 was primarily related to the timing of
cash flows between quarters, including reimbursement amounts from
the company’s collaboration partners and payments related to its
Phase 3 program for vadadustat, including $13.0 million of advanced
purchases of comparator drug inventory in anticipation of Brexit.
Additionally, cash was impacted by one-time payments of certain
previously accrued, merger-related liabilities totaling $30.0
million. The company continues to expect its cash resources,
including the prepaid quarterly committed cost-share funding from
its collaboration partners, to fund its current operating plan into
the third quarter of 2020.
Leadership Team AdditionsSteven K. Burke, M.D. will
succeed Rita Jain, M.D., who informed the company of her plans to
step down from her position as Senior Vice President, Chief Medical
Officer effective June 17, 2019 to pursue other opportunities. Dr.
Jain has been a valued member of the company’s leadership team, and
during her tenure made important contributions to the vadadustat
development program and enhanced the development organization. She
has advised the company that she is committed to supporting the
company during a transitional period and ensuring a seamless and
successful transition to her successor, Dr. Burke.
Dr. Burke will join the company from Proteon Therapeutics, Inc.,
where he has been Senior Vice President and Chief Medical Officer
since 2006. Prior to joining Proteon, Dr. Burke served as Senior
Vice President of Medical and Regulatory Affairs at Genzyme
Corporation, where he worked from 2001 to 2006. From 1994 to 2001,
Dr. Burke held roles at GelTex Pharmaceuticals, Inc. including Vice
President of Clinical Research and Medical Director, and before
that he held positions at Glaxo, Inc.. Dr. Burke received an A.B.
from Harvard College and an M.D. from Cornell University Medical
College. He completed a medical residency and fellowship at Brigham
and Women’s Hospital and is certified by the American Board of
Internal Medicine.
Dell Faulkingham joins the company with more than 20 years of
commercial experience across a broad range of specialty
pharmaceutical categories. His experience includes commercial
leadership roles with Biogen Inc., where he held multiple positions
of increasing responsibility, most recently serving as Senior Vice
President and Head, U.S. Multiple Sclerosis (MS) Franchise. Mr.
Faulkingham also recently served as Vice President, Head of U.S. MS
Marketing and Field Operations at Biogen. Prior to joining Biogen,
Mr. Faulkingham held several roles with Takeda Pharmaceuticals. Mr.
Faulkingham began his career in sales at Forest Pharmaceuticals,
Inc. and received a B.S. in biology from the University of
Georgia.
Conference Call:Akebia will host a conference call today,
Thursday, May 9, 2019, at 9:00 a.m. Eastern Time to discuss its
first quarter financial results. To listen to the conference call,
please dial (877) 458-0977 (domestic) or (484) 653-6724
(international) using conference ID number 4271217. 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 15, 2019. To
access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406
(international) and reference conference ID number 4271217. 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 TherapeuticsAkebia Therapeutics,
Inc. is a fully integrated biopharmaceutical company focused
on the development and commercialization of therapeutics for
patients with 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 VadadustatVadadustat is an oral hypoxia-inducible
factor prolyl hydroxylase inhibitor currently in global Phase 3
development for the treatment of anemia due to CKD. Vadadustat’s
proposed mechanism of action is designed to mimic the physiologic
effect of altitude on oxygen availability. At higher altitudes, the
body responds to lower oxygen availability with increased
production of hypoxia-inducible factor, which coordinates the
interdependent processes of iron mobilization and erythropoietin
production to increase red blood cell production and, ultimately,
improve oxygen delivery. Vadadustat is an investigational therapy
and is not approved by the U.S. Food and Drug
Administration (FDA) or any regulatory authority.
About Auryxia® (ferric citrate)
TabletsAuryxia (ferric citrate) was approved by
the FDA on September 5, 2014 for the control of
serum phosphorus levels in adult patients with CKD on dialysis and
approved by the FDA on November 6, 2017 for the
treatment of iron deficiency anemia in adult patients with CKD not
on dialysis. For more information about Auryxia and the U.S. full
prescribing information, please visit www.auryxia.com.
IMPORTANT U.S. SAFETY INFORMATION FOR
AURYXIA® (ferric citrate)
CONTRAINDICATIONAURYXIA® (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 REACTIONSMost 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 StatementsStatements 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 potential benefits of
vadadustat; the potential timing and basis of the JNDA filing for
vadadustat; the rate and timing of enrollment of our clinical
trials; the potential benefits of the combined company post-merger;
the market and growth potential of Auryxia; the anticipated timing
of the availability and presentation of clinical trial data and
results; management and key personnel changes and transitional
periods; potential and anticipated payments from our collaborators,
including the timing thereof; and expectations regarding financial
position, including the period of time cash resources, including
committed funding from our collaborators will fund our current
operating plan. The terms “anticipate,” “believe,” “expect,”
“opportunity,” “planned,” “potential,” “target,” “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 the rate of enrollment in clinical studies of vadadustat;
risks associated with market acceptance and coverage and
reimbursement of Auryxia; the risks associated with potential
generic entrants for Auryxia; the rate of major adverse
cardiovascular events in our global phase 3 clinical trials for
vadadustat; the risk that clinical trials may not be successful;
the risk that existing preclinical and clinical data may not be
predictive of the results of ongoing or later clinical trials;
manufacturing risks; the quality and manner of the data that will
result from clinical studies of vadadustat; risks associated with
management and key personnel changes and transitional periods; the
actual funding required to develop and commercialize Akebia’s
product candidates and operate the company, and the actual expenses
associated therewith; the actual costs incurred in the clinical
studies of vadadustat and the availability of financing to cover
such costs; the risk that clinical studies are discontinued or
delayed for any reason, including for safety, tolerability,
enrollment, manufacturing or economic reasons; early termination of
any of Akebia’s collaborations; Akebia’s and its collaborators’
ability to satisfy their obligations under Akebia’s collaboration
agreements; the timing and content of decisions made by regulatory
authorities; the timing of any additional studies initiated for
vadadustat; the actual time it takes to initiate and complete
preclinical and clinical studies; the competitive landscape
for Auryxia and vadadustat; the scope, timing, and outcome of any
ongoing legal, regulatory and administrative proceedings; changes
in the economic and financial conditions of the businesses of
Akebia and its partners; and Akebia’s ability to obtain, maintain
and enforce patent and other intellectual property protection for
Auryxia, 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 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 Akebia does not undertake, and specifically disclaims,
any obligation to update any forward-looking statements contained
in this press release.
AKEBIA THERAPEUTICS, INC.Consolidated Statements
of Operations(in thousands, except share and per share
data)(unaudited) Three
Months Ended March 31, 2019 March 31,
2018 Revenues: Product revenue, net $ 23,111 $ — License,
collaboration and other revenue 49,555 45,930
Total revenues 72,666 45,930 Cost of goods sold: Product
22,157 — Amortization of intangibles 9,100 —
Total cost of goods sold 31,257 — Operating expenses:
Research and development 82,351 61,404 Selling, general and
administrative 34,291 9,024 License expense 736
— Total operating expenses 117,378
70,428 Operating loss (75,969 ) (24,498 ) Other
income, net 791 1,080 Net loss before
income taxes (75,178 ) (23,418 ) Benefit from income taxes
(2,757 ) — Net loss $ (72,421 ) $ (23,418 ) Net loss
per share - basic and diluted $ (0.62 ) $ (0.48 ) Weighted-average
number of commons shares - basic and diluted 117,063,352
48,613,565
AKEBIA THERAPEUTICS,
INC.Selected Balance Sheet Data(in
thousands)(unaudited)
March 31, 2019 December 31, 2018 Cash,
cash equivalents and available for sale securities $ 168,038 $
321,640 Working capital 144,620 202,582 Total assets 890,793
996,540 Total stockholders’ equity 566,379 635,928
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version on businesswire.com: https://www.businesswire.com/news/home/20190509005189/en/
Kristen K. Sheppard, Esqksheppard@akebia.com
Akebia Therapeutics (NASDAQ:AKBA)
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