Full Press Release Details
Akebia Reports First Quarter 2021 Financial Results and Highlights Recent Company Milestones
CAMBRIDGE, Mass. May 10, 2021 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 first quarter ended March 31, 2021 and highlighted recent corporate milestones. The Company will
host a conference call today, Monday, May 10, 2021, at 9:00 a.m. Eastern Time.
Akebia is off to a great start in 2021, building positive
momentum with solid execution on strategic priorities that set the stage for an exciting year. Most importantly, we submitted the vadadustat NDA to the FDA, a significant milestone for Akebia and our partner, Otsuka Pharmaceutical Co. Ltd. We are
also very proud that the New England Journal of Medicine recently published the results from both INNO2VATE and PRO2TECT, the
global Phase 3 programs for vadadustat. We believe these publications reinforce the scientific rigor and quality of the vadadustat clinical development program, and we are pleased with early feedback from the medical community, stated John P.
Butler, Chief Executive Officer of Akebia. We believe this progress positions us well to continue advancing vadadustat with the goal of bringing this novel therapeutic to patients as quickly as possible, subject to regulatory approval. We
remain confident in the clarity and quality of our data, and we look forward to engaging with the FDA on our NDA. In addition, we are working with Otsuka on the preparation of a Marketing Authorization Application (MAA) for vadadustat for submission
to the European Medicines Agency (EMA), expected this year.
Recent Business Highlights:
First Quarter Financial Results
Despite the ongoing impact of COVID-19 on dialysis patients, we are encouraged by Auryxia s revenue growth in the first quarter of 2021 when compared to the prior year s period. We believe this performance highlights Auryxia s
favorable product profile and the critical nature of this therapy, as well as our team s ability to execute at a high level, stated David A. Spellman, Chief Financial Officer of Akebia. While we remain cautious due to COVID-19, together with our continued commercial efforts, we believe that Auryxia s positioning will drive product revenue growth for the year.
Akebia will host a conference call at
9:00 a.m. Eastern Time today, Monday, May 10, to discuss its first quarter financial results and recent business highlights. To listen to the conference call, please dial (877) 458-0977
(domestic) or (484) 653-6724 (international) using conference ID number 6250159. 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 16, 2021. To access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and reference
conference ID number 6250159. 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 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 recently completed its global Phase 3 development program for the treatment of anemia due to CKD. Vadadustat is not approved by the U.S. Food and Drug Administration (FDA) or any other 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 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
SPECIFIC POPULATIONS
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 connection between the publication of results INNO2VATE and PRO2TECT in the New England Journal
of Medicine and vadadustat s clinical development program; the commercialization of vadadustat, if approved, and the timing thereof; the timing of submission of an MAA for vadadustat to EMA; the potential impact of COVID-19; the potential for product revenue growth in 2021; and the timing and expectations for the Company s cash runway in relation to the expected timing of the U.S. launch of vadadustat, assuming timely
regulatory approval and the receipt of associated regulatory milestones. The terms believe, confident, expect, plan, potential, 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, but not limited to: the timing of regulatory filings and approvals; interactions with the FDA, including reviews and inspections, the timing related thereto and the outcome thereof; the potential
therapeutic benefits, safety profile and effectiveness of our product candidates, including vadadustat; the direct or indirect impact of the COVID-19 pandemic on our business, operations, and the markets and
communities in which the Company and its partners, collaborators, vendors and customers operate; the timing and content of advice given and decisions made by health authorities, including approval and labeling decisions; the potential indications,
demand and market potential and acceptance of, as well as coverage and reimbursement related to, Auryxia and vadadustat, if approved, including estimates regarding the potential market opportunity for the Company s product, vadadustat or any
other product candidates and the size of eligible patient populations; enrollment in clinical and preclinical studies; manufacturing, supply and quality risks, and any recalls, write-downs, impairments or other related consequences or potential
consequences; risks associated with hiring, training, management and retention and key personnel changes and transitional periods; the actual funding required to continue to commercialize Akebia s commercial product, to develop and
commercialize vadadustat, and to operate the Company; the risks associated with potential generic entrants for Akebia s commercial product and vadadustat, if approved; early termination of or changes to the terms of agreements that Akebia has
collaborations; Akebia s and its collaborators ability to satisfy their obligations under Akebia s collaboration agreements; the competitive landscape for Akebia s commercial
product and vadadustat, if approved; 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 collaborations partners and vendors;
expected reliance on third parties, including with respect to the development, manufacturing, supply or commercialization of Akebia s product and product candidates; the Company s expectations, projections and estimates regarding its
capital requirements; and Akebia s intellectual property position, including its ability to obtain, maintain and enforce patent and other intellectual property protection for its commercial product, 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 for the year ended December 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, except as required by law, 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 | ||||||||
| March 31, 2021 | March 31, 2020 | |||||||
| Revenues: | ||||||||
| Product revenue, net | $ | 30,408 | $ | 29,209 | ||||
| License, collaboration and other revenue | 21,896 | 59,269 | ||||||
| Total revenues | 52,304 | 88,478 | ||||||
| Cost of goods sold: | ||||||||
| Product | 25,595 | 18,613 | ||||||
| Amortization of intangibles | 9,011 | 9,100 | ||||||
| Impairment of intangible asset | ||||||||
| Total cost of goods sold | 34,606 | 27,713 | ||||||
| Operating expenses: | ||||||||
| Research and development | 40,611 | 81,231 | ||||||
| Selling, general and administrative | 41,328 | 37,983 | ||||||
| License expense | 695 | 676 | ||||||
| Total operating expenses | 82,634 | 119,890 | ||||||
| Operating loss | (64,936 | ) | (59,125 | ) | ||||
| Other expense, net | (4,644 | ) | (1,622 | ) | ||||
| Net loss | $ | (69,580 | ) | $ | (60,747 | ) | ||
| Net loss per share - basic and diluted | $ | (0.45 | ) | $ | (0.47 | ) | ||
| Weighted-average number of common shares - basic and diluted | 153,820,809 | 128,395,163 |
AKEBIA THERAPEUTICS, INC.
Selected Balance Sheet Data
| March 31, 2021 | December 31, 2020 | |||||||
| Cash, cash equivalents and available for sale securities | $ | 272,764 | $ | 268,690 | ||||
| Working capital | 192,338 | 184,291 | ||||||
| Total assets | 628,703 | 644,139 | ||||||
| Total stockholders equity | 213,891 | 247,618 |