Akebia Therapeutics Reports First Quarter 2022 Financial Results and Business Update
CAMBRIDGE, Mass., May 9, 2022 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced financial results for the first quarter ended March 31, 2022 and provided business updates.
"While we were surprised and disappointed by the vadadustat Complete Response Letter we received from the FDA in March, our team has responded aggressively by working to strengthen and secure the company financially, with an aim of allowing us to continue to deliver on our purpose to better the lives of people impacted by kidney disease. We plan to focus on Auryxia commercial success while exploring our earlier stage assets and pursuing other value creating business opportunities," said John Butler, Chief Executive Officer of Akebia. "The past six months of Auryxia net sales have been the strongest ever. This is a testament to the strength of our commercial team, which has delivered, even as COVID-19 disproportionately impacted the patients we serve. As we emerge from the pandemic, we believe Auryxia revenue is positioned to continue to grow and provide a solid basis for ongoing financial support for the company."
Akebia has outlined three pillars of its refined strategic focus:
Akebia refined its strategic focus following receipt on March 29, 2022 of a Complete Response Letter (CRL) from the U.S. Food & Drug Administration (FDA) for Akebia's New Drug Application for vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor for the treatment of anemia due to chronic kidney disease. Akebia plans to request an end of review meeting with the FDA within ninety days of receipt of the CRL. Akebia plans to evaluate and determine potential next steps for vadadustat in the U.S. following the end of review meeting with the FDA. In the meantime, the company is focused on its path forward without a U.S. approval for vadadustat.
"There has been significant effort made since our CRL in March to streamline our operations with a goal of funding operations from the cash flows of Auryxia as well as funds from our collaboration partners," said David A. Spellman, Chief Financial Officer of Akebia. "There is still work to do, and we are focused on delivering increased revenue and greater cost savings. If we are successful in implementing cost avoidance measures, we believe we will have cash flows to support the business through at least the next twelve months and do not anticipate a near-term requirement to further finance the company to execute our operating plan."
A replay of the conference call will be available two hours after the completion of the call through May 15, 2022. To access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and reference conference ID number 1273066. An online archive of the conference call can be accessed via the Investors section of Akebia'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 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 an investigational new drug and is not approved by the U.S. Food and Drug Administration (FDA). On March 29, 2022, the FDA issued a complete response letter to Akebia's New Drug Application for vadadustat for the treatment of anemia due to chronic kidney disease (CKD). Vadadustat is currently under review by the European Medicines Agency for the treatment of anemia due to CKD in adults. In Japan, vadadustat is approved as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients.
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:
To report suspected adverse reactions, contact Akebia Therapeutics at 1-844-445-3799.
Please see full Prescribing Information
Forward Looking Statement
Statements in this press release regarding Akebia Therapeutics, Inc.'s ("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, and include, but are not limited to, statements regarding: Akebia's plans, strategies and prospects for its business, including with respect to Akebia's response to the receipt of the Complete Response Letter (the "CRL") that it received in March 2022; Akebia's future plans with respect to its strategic growth and operating plans, including as it relates to regulatory submissions outside of the U.S.; Akebia's belief that Auryxia revenue will continue to grow and provide a solid basis for ongoing financial support for the company; Akebia's revenue guidance for Auryxia in 2022 and assumptions related thereto; Akebia's plans to request a review meeting with the FDA within 90 days of receipt of the CRL and its plans with respect to vadadustat thereafter; Akebia's expectations related to its April and May 2022 workforce reduction, future charges expected to be incurred in connection therewith and estimated reductions in net cash required for operating activities in connection therewith; and Akebia's goals, objectives and expectations with respect to its operating plan, cash resources and sources of funding for its cash runway, including its ability to deliver greater cost savings, its belief that it will have cash flows to support the business through at least the next twelve months and its belief that it does not anticipate a near-term requirement to further finance the company in order to execute its current anticipated operating plan. The terms "intend," "believe," "plan," "goal," "expect," "potential," "will," "continue," derivatives of these words, and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to, risks associated with: the potential demand and market potential and acceptance of, as well as coverage and reimbursement related to, Auryxia, including estimates regarding the potential market opportunity; the competitive landscape for Auryxia, including potential generic entrants; Akebia's ability to successfully implement its workforce reduction plan and reduce expenses; the impact of the workforce reduction on Akebia's business; the ability of Akebia to attract and retain qualified personnel; Akebia's ability to implement cost avoidance measures and reduce overhead costs, including its ability to execute amendments to certain contractual arrangements and reduce infrastructure costs; decisions made by health authorities, such as the FDA and the European Medicines Agency, with respect to regulatory filings, including the New Drug Application for vadadustat; the potential therapeutic benefits, safety profile, and effectiveness of vadadustat; the direct or indirect impact of the COVID-19 pandemic on regulators and Akebia's business, operations, and the markets and communities in which Akebia and its partners, collaborators, vendors and customers operate; manufacturing, supply chain and quality matters and any recalls, write-downs, impairments or other related consequences or potential consequences; and early termination of any of Akebia's collaborations. 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, 2021, 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.
Akebia Therapeutics® and Auryxia are registered trademarks of Akebia Therapeutics, Inc. and its affiliates.
Akebia Therapeutics Contact
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SOURCE Akebia Therapeutics
Company Codes: NASDAQ-NMS:AKBA