Akebia Therapeutics Announces Preliminary Full-Year 2018 Financial Results and Business Highlights
– Substantial revenue growth opportunity for Auryxia following robust 2018 commercial performance –
– First regulatory submission for vadadustat expected in 2019 in
– Multiple vadadustat phase 3 readouts expected over next 18 months –
“2018 was a transformational year for Akebia,” said
Mr. Butler continued, “With respect to vadadustat, our lead product candidate, we believe that it has the potential to set a new standard of care for patients with anemia due to chronic kidney disease with a differentiated clinical profile. We recently announced positive top-line results from two pivotal phase 3 studies in
- Pro forma unaudited Auryxia sales in 2018 were
$96 million, representing 72% growth over 2017.
- Total Auryxia prescriptions for 2018 were approximately 163,000, representing 85% growth over 2017.
- Exit market share for Auryxia tablets in 2018 was 6.6% compared to 4.2% in 2017, exceeding the share gain of all other phosphate binders (branded and generic) in the same period.
Vadadustat Japanese Phase 3 Program
- Announced positive top-line results from two phase 3, active-controlled, pivotal studies evaluating vadadustat in Japanese subjects with anemia due to chronic kidney disease (CKD).
- Data from these two pivotal studies as well as from two additional single-arm studies in peritoneal dialysis and hemodialysis subjects, also recently announced, is expected to serve as the basis for a Japanese New Drug Application (JNDA) submission by
Mitsubishi Tanabe Pharma Corporation(MTPC), expected in 2019.
Vadadustat Global Phase 3 Program
- Enrollment in the larger of the two
INNO2 VATEstudies (the “Conversion Study”) was completed in February 2019, with a total of 3,554 subjects enrolled. Enrollment in the smaller INNO2 VATEstudy (the “Correction Study”), enrolling approximately 350 subjects, is expected to be completed by April 2019. The company expects to report top-line data from both INNO2 VATEstudies in the second quarter of 2020, subject to the accrual of major adverse cardiac events (MACE).
- The company expects enrollment in the PRO2TECT studies to complete in 2019, with up to approximately 3,700 subjects expected to be enrolled. Top-line results are anticipated in mid-2020, subject to the accrual of MACE.
- The two
INNO2 VATEstudies evaluating dialysis-dependent CKD subjects and the two PRO2TECT studies evaluating non-dialysis dependent CKD subjects are global, phase 3, active-controlled, open-label, non-inferiority, cardiovascular outcome studies of vadadustat for the treatment of anemia due to CKD.
Preliminary Financial Results (unaudited)
As a result of the completion of the company’s business combination with
Net product revenues for Auryxia from
Collaboration revenues for the fourth quarter of 2018 were
Collaboration revenues for the full year 2018 were
Cost of goods sold was
Research and development expenses were
Selling, general and administrative expenses were
Akebia reported a pre-tax net loss for the fourth quarter of 2018 of
For the full year 2018, the Company reported a pre-tax net loss of
Akebia ended 2018 with cash, cash equivalents and available-for-sale securities of
Conference Call and Webcast
Akebia management will host its full-year 2018 and business highlights conference call and webcast beginning at
The conference call can be accessed by dialing (877) 458-0977 within
A live webcast of the conference call will be available in the “Investors” section of the company’s website at www.akebia.com.
Beginning the morning of
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
About Auryxia® (ferric citrate) Tablets
Auryxia (ferric citrate) was approved by the
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.
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
Please see full Prescribing Information
Note Regarding Preliminary Financial Results (unaudited)
As a result of the completion of the company’s business combination with Keryx on
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; potential and anticipated payments from our collaborators, including the timing thereof; the preliminary unaudited financial results under the heading “Preliminary Financial Results (Unaudited)” and the other financial information included in this press release; 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 that the preliminary fourth quarter and full-year 2018 results may require updates and revisions in connection with the completion of the company’s internal review and auditing procedures; 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; 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 most recently filed Quarterly Report on Form 10-Q 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||Twelve Months Ended|
|December 31, 2018||December 31, 2017||December 31, 2018||December 31, 2017|
|Product revenue, net||$||6,824||$||—||$||6,824||$||—|
|License, collaboration and other revenue||53,026||90,559||200,918||181,227|
|Cost of goods sold||6,251||—||6,251||—|
|Amortization of intangibles||1,434||—||1,434||—|
|Research and development||87,113||68,382||291,068||230,893|
|Selling, general and administrative||55,121||7,567||87,061||27,008|
|Total operating expenses||149,986||75,949||385,881||257,901|
|Operating income (loss)||(90,136||)||14,610||(178,139||)||(76,674||)|
|Other income, net||1,766||913||6,235||3,003|
|Net income (loss) before taxes||$||(88,370||)||$||15,523||$||(171,904||)||$||(73,671||)|
Melissa Forst / Maghan Meyers