Full Press Release Details
Akebia Reports Second Quarter 2020 Financial Results
CAMBRIDGE, Mass. August 10, 2020 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 second quarter ended June 30, 2020. As previously announced, in lieu of a financial results and business update call, Akebia management plans to
host a conference call and webcast in early September to report top-line data from PRO2TECT, the second of its two global Phase 3 cardiovascular outcomes
programs. The two PRO2TECT studies evaluated the efficacy and safety of vadadustat, the Company s investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of anemia due to chronic kidney disease (CKD) in adult patients not on dialysis.
had an incredible quarter in terms of advancing our vadadustat clinical development program, bringing us that much closer to achieving our purpose to better the life of each person impacted by kidney disease. We reported exciting, positive top-line data from our global Phase 3 INNO2VATE program highlighting vadadustat s potential as a new oral standard of care for treating anemia due to CKD
in adult patients on dialysis, and topped off the quarter with the first regulatory approval of vadadustat in Japan, said John P. Butler, President and Chief Executive Officer of Akebia Therapeutics. The next chapter of Akebia s
growth story is starting to unfold and as previously announced, we plan to share top-line data from PRO2TECT in early September.
Recent Business Highlights
Second Quarter Financial Results
The non-cash impairment charge reflects the change in value of the Auryxia intangible asset on our balance
sheet, primarily driven by the compounding impact of the 2018 decision by the Centers for Medicare and Medicaid Services (CMS) rescinding Medicare Part D coverage of Auryxia for its IDA indication and imposing a prior authorization requirement for
the hyperphosphatemia indication, stated David A. Spellman, Chief Financial Officer of Akebia Therapeutics. While we are frustrated and disappointed that a resolution has not been reached on this matter for the benefit of patients, we
remain optimistic about Auryxia s growth prospects.
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.
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 is in global Phase 3 development for the treatment of anemia due to CKD and is not approved by the U.S. Food and
(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 Auryxia (ferric citrate) Tablets
Auryxia (ferric citrate) was approved by FDA on September 5, 2014
for the control of serum phosphorus levels in adult patients with CKD on dialysis (the hyperphosphatemia indication ) and approved by FDA on November 6, 2017 for the treatment of iron deficiency anemia in adult patients with CKD not
on dialysis (the IDA indication ). For more information about Auryxia and the U.S. full prescribing information, please visit www.auryxia.com.
About Anemia due to Chronic Kidney Disease (CKD)
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
Most common adverse reactions with AURYXIA were:
SPECIFIC POPULATIONS
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 plans to report top-line data from PRO2TECT and the anticipated timing thereof; Akebia s growth story and growth
prospects; the safety and efficacy of vadadustat and the potential indications for and benefits of vadadustat; and estimates, beliefs and judgments related to the impairment charge, including the drivers thereof. 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
potential direct or indirect impact of the COVID-19 pandemic on our and our partners , collaborators , vendors and customers businesses, operations, and the markets and communities in
which we and our partners, collaborators, vendors and customers operate; the risk that existing preclinical and clinical data may not be predictive of the results of ongoing or later clinical trials, including PRO2TECT; the risk that clinical trials may not be successful; manufacturing risks; risks associated with the Priority Review Voucher for vadadustat; risks associated with management and key personnel
changes and transitional periods; the actual funding required to develop and commercialize our commercial product, vadadustat and other 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; market acceptance and coverage and reimbursement of our commercial product and vadadustat; the risks associated with potential generic entrants for our commercial product and vadadustat; early termination of any of Akebia s
collaborations and material contracts; Akebia s and its collaborators ability to satisfy their obligations under Akebia s collaboration agreements and material contracts; 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 our commercial product and vadadustat; 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 partners; and Akebia s 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 March 31, 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 Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release.
Kristen K. Sheppard, Esq.
AKEBIA THERAPEUTICS, INC.
Consolidated Statements of Operations
(in thousands, except share and per share data)
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, 2020 | June 30, 2019 | June 30, 2020 | June 30, 2019 | |||||||||||||
| Revenues: | ||||||||||||||||
| Product revenue, net | $ | 30,696 | $ | 29,089 | $ | 59,905 | $ | 52,200 | ||||||||
| License, collaboration and other revenue | 59,446 | 71,714 | 118,715 | 121,269 | ||||||||||||
| Total revenues | 90,142 | 100,803 | 178,620 | 173,469 | ||||||||||||
| Cost of goods sold: | ||||||||||||||||
| Product | 49,988 | 28,569 | 68,601 | 50,726 | ||||||||||||
| Amortization of intangibles | 9,101 | 9,100 | 18,201 | 18,200 | ||||||||||||
| Impairment of intangible asset | 115,527 | 115,527 | ||||||||||||||
| Total cost of goods sold | 174,616 | 37,669 | 202,329 | 68,926 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 52,819 | 85,694 | 134,050 | 168,045 | ||||||||||||
| Selling, general and administrative | 35,482 | 36,068 | 73,465 | 70,359 | ||||||||||||
| License expense | 1,044 | 895 | 1,720 | 1,631 | ||||||||||||
| Total operating expenses | 89,345 | 122,657 | 209,235 | 240,035 | ||||||||||||
| Operating loss | (173,819 | ) | (59,523 | ) | (232,944 | ) | (135,492 | ) | ||||||||
| Other income (expense), net | (1,932 | ) | 508 | (3,554 | ) | 1,299 | ||||||||||
| Net loss before income taxes | (175,751 | ) | (59,015 | ) | (236,498 | ) | (134,193 | ) | ||||||||
| Benefit from income taxes | (845 | ) | (3,602 | ) | ||||||||||||
| Net loss | $ | (175,751 | ) | $ | (58,170 | ) | $ | (236,498 | ) | $ | (130,591 | ) | ||||
| Net loss per share - basic and diluted | $ | (1.28 | ) | $ | (0.49 | ) | $ | (1.78 | ) | $ | (1.11 | ) | ||||
| Weighted-average number of common shares - basic and diluted | 136,906,968 | 118,268,832 | 132,651,066 | 117,669,422 |
AKEBIA THERAPEUTICS, INC.
Selected Balance Sheet Data
| June 30, 2020 | December 31, 2019 | |||||||
| Cash, cash equivalents and available for sale securities | $ | 295,349 | $ | 147,694 | ||||
| Working capital | 253,328 | 101,415 | ||||||
| Total assets | 745,174 | 771,201 | ||||||
| Total stockholders equity | 370,260 | 394,757 |