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 related to regulatory filings and approvals, such as the anticipated timing of filing the NDA to the FDA and MAA to the EMA for vadadustat and our outlook related thereto; the direct or indirect impact of the COVID-19 pandemic on Akebia's business, operations, and the markets and communities in which the Company and its partners, collaborators, vendors and customers operate; the potential therapeutic benefits, safety profile and effectiveness of Akebia's product candidates, including vadadustat; 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 Akebia's product and product candidates, 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; market acceptance and coverage and reimbursement of the Company's commercial product and vadadustat, if approved; the risks associated with potential generic entrants for Akebia's commercial product and vadadustat, if approved; early termination of any of Akebia's 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, need for additional capital, financing our future cash needs, costs, expenses, revenues, capital resources, cash flows, financial performance, profitability, tax obligations, liquidity, growth, contractual obligations, our internal control over financial reporting and disclosure controls and procedures, and remediation of any material weakness or deficiencies identified in our internal controls and procedures; and Akebia's intellectual property position, including its ability to obtain, maintain and enforce patent and other intellectual property protection for our commercial product, vadadustat and any other product candidates. akba The Nasdaq Global Market Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter). ™ (vadadustat), and certain other Asian countries. Akebia Therapeutics Inc Q1 2020 earnings call dated May 05, 2020Corporate Participants: Kristen Sheppard — Vice President, Investor Relations. A list of all funds holding AKBA. After the aggregate cap is met, Akebia will recognize 100 percent of Vafseo royalties and sales milestones until this revenue stream ends under the terms of the Company's collaboration agreement with MTPC. Akebia plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for vadadustat by the middle of the second quarter of this year for the treatment of anemia due to CKD in both adult patients on dialysis and adult patients not on dialysis. 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. University of Texas Health Science Center at Houston, HVAC (Heating, Ventilation and Air-Conditioning), Machine Tools, Metalworking and Metallurgy, Aboriginal, First Nations & Native American, Nephrology Dialysis Transplantation (NDT). About VadadustatVadadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. SEC filing (typically a 10-K). Easily access company info and prior drug data Piper Sandler analyst Christopher Raymond remains Overweight rated on Akebia shares, and sees the disclosu 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. Patients with iron overload syndromes, e.g., hemochromatosis ( HIF-PH ) inhibitor designed to mimic physiologic... Akba shares plunge on failed Phase 3 Development program for the treatment anemia! 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