Akebia Therapeutics Reports First Quarter 2019 Financial Results; Announces Full Enrollment of Phase 3 INNO2VATE Studies and Announces Key Executive Appointments
- Net Product Revenue for Auryxia Increases to
$23.1 Millionfor 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.
“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),”
Butler continued, “We are also pleased to announce the completion of
enrollment in our global Phase 3
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.
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 Pharmaannounced in April 2019creates 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
INNO2 VATEstudies 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.
Total revenue for the first quarter of 2019 was
Auryxia net product revenue for the first quarter of 2019 was
“As we previously discussed, the
Collaboration revenue for the first quarter of 2019 was
Cost of goods sold was
Research and development expenses were
Selling, general and administrative expenses were
The company reported a net loss for the first quarter of 2019 of
The company ended the quarter with cash, cash equivalents and
available-for-sale securities of
Leadership Team Additions
Dr. Burke will join the company from
Akebia will host a conference call today,
A replay of the conference call will be available two hours after the
completion of the call through
About Akebia Therapeutics
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 (
About Auryxia® (ferric citrate) Tablets
Auryxia (ferric citrate) was approved by the FDA on
IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA® (ferric
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.
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%).
- 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
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
|AKEBIA THERAPEUTICS, INC.
Consolidated Statements of Operations
(in thousands, except share and per share data)
|Three Months Ended|
|March 31, 2019||March 31, 2018|
|Product revenue, net||$||23,111||$||—|
|License, collaboration and other revenue||49,555||45,930|
|Cost of goods sold:|
|Amortization of intangibles||9,100||—|
|Total cost of goods sold||31,257||—|
|Research and development||82,351||61,404|
|Selling, general and administrative||34,291||9,024|
|Total operating expenses||117,378||70,428|
|Other income, net||791||1,080|
|Net loss before income taxes||(75,178||)||(23,418||)|
|Benefit from income taxes||(2,757||)||—|
|Net loss per share - basic and diluted||$||(0.62||)||$||(0.48||)|
|Weighted-average number of commons shares - basic and diluted||117,063,352||48,613,565|
|AKEBIA THERAPEUTICS, INC.
Selected Balance Sheet Data
|March 31, 2019||December 31, 2018|
|Cash, cash equivalents and available for sale securities||$||168,038||$||321,640|
|Total stockholders’ equity||566,379||635,928|
Kristen K. Sheppard, Esq