Akebia Therapeutics Reports First Quarter 2019 Financial Results; Announces Full Enrollment of Phase 3 INNO2VATE Studies and Announces Key Executive Appointments

BusinessWire

5 years ago

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.

CAMBRIDGE, Mass.–(BUSINESS WIRE)–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 Results
Total 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 Additions
Steven 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 Therapeutics
Akebia 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 Vadadustat
Vadadustat 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) Tablets
Auryxia
(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) 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 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

Contacts

Kristen K. Sheppard, Esq
ksheppard@akebia.com

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