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Akebia to host conference call on November 3 at 4:30 p.m. ET
CAMBRIDGE, Mass., Nov. 3, 2022 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today reported financial results for the third quarter ended September 30, 2022 and provided business highlights.
"Our team continues to execute a strategy aligned with our three strategic pillars, drive Auryxia revenue while managing costs, support the regulatory processes for vadadustat globally, and thoughtfully invest in our pipeline," said John P. Butler, Chief Executive Officer of Akebia. "Our team is leading the regulatory review of vadadustat in Europe and select ACCESS markets. Between those review processes and the submission of a request for formal dispute resolution with the FDA regarding the Complete Response Letter for vadadustat in the U.S., we anticipate the fourth quarter could bring some clarity and a timeframe for our ability to potentially obtain approval for vadadustat in various markets."
In October 2022, Akebia submitted a Formal Dispute Resolution Request (FDRR) with the U.S. Food & Drug Administration (FDA) regarding the Complete Response Letter (CRL) received in March 2022 for vadadustat, which was under review as a treatment for anemia due to chronic kidney disease (CKD). The FDRR focuses on the favorable balance of the benefits and risks of vadadustat for the treatment of anemia due to CKD in adult patients on dialysis in light of safety concerns expressed by the FDA in the CRL related to the rate of adjudicated thromboembolic events driven by vascular access thrombosis for vadadustat compared to the active comparator and the risk of drug-induced liver injury. Based on the typical FDRR process, Akebia expects to receive a response to its submission by the end of 2022.
"We act in the interest of patients impacted by kidney disease and believe in the favorable balance of the benefits and risks of vadadustat as a treatment for anemia due to chronic kidney disease," said John P. Butler, Chief Executive Officer of Akebia. "To that end, we are continuing to pursue a path that could potentially lead to an approval of vadadustat for dialysis dependent patients in the U.S."
The company had additional important business updates since the beginning of the third quarter of 2022:
"Managing operating expenses is critical as we look for opportunities to add value to the company," said David A. Spellman, Chief Financial Officer of Akebia. "By focusing on operating expenses and winding down certain projects, we're pleased to report a reduction in spend quarter over quarter in 2022. Auryxia net product revenue increased in the third quarter of 2022 from the third quarter of 2021. There was a slight decline from the second quarter of 2022 partially due to the drawdown of inventory at certain customers during the third quarter of 2022. In addition, since the start of COVID, the phosphate binder market has contracted 15%. While the phosphate binder market has continued to decline, the work we've done to increase net price per pill puts us in a position to affirm our 2022 net product revenue guidance for Auryxia of $170 - $175 million."
Financial Results
Conference Call
Akebia will host a conference call on November 3 at 4:30 p.m. ET to discuss its financial results and recent company highlights. Access to the call will be provided via a new process. To access the call, please register by clicking on this Registration Link, and then you will be provided with dial in details. To avoid delays, we encourage dialing into the conference call fifteen minutes ahead of the scheduled start time.
A live webcast of the conference call will be available via the Investors section of Akebia's website at: https://ir.akebia.com/. An online archive of the webcast can be accessed via the Investors section of Akebia's website at http://ir.akebia.com approximately two hours after the event.
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.
About Vadadustat
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
ADVERSE REACTIONS
Most common adverse reactions with AURYXIA were:
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 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 the Formal Dispute Resolution Request, or FDRR, that Akebia submitted with the FDA to appeal the Complete Response Letter that it received in March 2022; Akebia's future plans with respect to its strategic growth and operating plans; Akebia's revenue guidance for Auryxia in 2022 and assumptions related thereto; Akebia's plans with respect to vadadustat as a treatment of anemia due to CKD in patients on dialysis; 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 belief that its existing cash resources and revenues from Auryxia will be sufficient to fund its current operating plan for at least the next twelve months. 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; 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 planned amendments to certain contractual arrangements and reduce operating expenses; decisions made by health authorities, such as the FDA and the European Medicines Agency, with respect to regulatory filings, including the New Drug Application and the FDRR 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, 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® (ferric citrate) are registered trademarks of Akebia Therapeutics, Inc. and its affiliates.
Akebia Therapeutics Contact
Mercedes Carrasco
mcarrasco@akebia.com
AKEBIA THERAPEUTICS, INC. | |||||||
Consolidated Statements of Operations | |||||||
(in thousands, except share and per share data) | |||||||
(unaudited) | |||||||
Three Months Ended | Nine Months Ended | ||||||
September 30, | September 30, | September 30, | September 30, | ||||
Revenues: | |||||||
Product revenue, net | $ 42,239 | $ 36,753 | $ 127,390 | $ 100,120 | |||
License, collaboration and other revenue | 6,725 | 12,003 | 110,032 | 53,853 | |||
Total revenues | 48,964 | 48,756 | 237,422 | 153,973 | |||
Cost of goods sold: | |||||||
Product | 28,936 | 6,933 | 60,859 | 76,012 | |||
Amortization of intangibles | 9,011 | 9,011 | 27,032 | 27,032 | |||
Total cost of goods sold | 37,947 | 15,944 | 87,891 | 103,044 | |||
Operating expenses: | |||||||
Research and development | 27,350 | 40,471 | 97,210 | 118,296 | |||
Selling, general and administrative | 30,918 | 46,357 | 108,052 | 129,336 | |||
License expense | 743 | 870 | 2,323 | 2,460 | |||
Restructuring | 180 | — | 14,711 | — | |||
Total operating expenses | 59,191 | 87,698 | 222,296 | 250,092 | |||
Operating (loss) | (48,174) | (54,886) | (72,765) | (199,163) | |||
Other expense, net | (2,785) | (4,658) | (11,339) | (12,999) | |||
Loss on extinguishment of debt | (906) | — | (906) | — | |||
Net (loss) | $ (51,865) | $ (59,544) | $ (85,010) | $ (212,162) | |||
Net (loss) per share - basic | $ (0.28) | $ (0.34) | $ (0.47) | $ (1.30) | |||
Weighted-average number of common shares - basic | 183,882,446 | 173,782,151 | 182,375,443 | 163,050,769 |
AKEBIA THERAPEUTICS, INC. | |||
Selected Balance Sheet Data | |||
(in thousands) | |||
(unaudited) | |||
September 30, 2022 | December 31, 2021 | ||
Cash and cash equivalents | $144,761 | $149,800 | |
Working capital | 49,547 | 15,517 | |
Total assets | 435,894 | 525,550 | |
Total stockholders' equity | 13,853 | 76,456 |
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SOURCE Akebia Therapeutics