Full Press Release Details
Akebia Therapeutics Reports First Quarter 2023 Financial Results and Recent Business Highlights
Akebia to host conference call on May 8 at 8:30 a.m. ET
CAMBRIDGE, Mass. May 8, 2023 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 first quarter ended March 31, 2023 and provided business highlights.
Approval of Vafseo (vadadustat) by the European Commission is a significant milestone for us
and for dialysis patients in Europe with anemia due to chronic kidney disease, said John P. Butler, Chief Executive Officer of Akebia. This is an important step as we continue to deliver on our commitment to better the lives of people
with kidney disease. Now we are working to complete a partnership to launch Vafseo in Europe, and we are eager to conclude our appeal process with the FDA.
In April, the European Commission granted marketing authorization for Vafseo (vadadustat), for the treatment of symptomatic anemia associated with chronic
kidney disease (CKD) in adults on chronic maintenance dialysis. Akebia plans to select a partner to commercialize Vafseo in Europe. Vadadustat is now approved in 32 countries. Akebia also expects a regulatory opinion on vadadustat in the United
Kingdom, Switzerland and Australia over the course of this year.
In the U.S., Akebia has continued to engage with the Office of New Drugs on its Formal
Dispute Resolution regarding vadadustat. Dr. Stein, the deciding authority on the appeal, indicated he has completed his internal discussions, and the company expects a response within the next 30 days.
Akebia also recently reported positive top-line results from
FO2CUS, a study evaluating the efficacy and safety of vadadustat in hemodialysis patients who were converted from a long-acting erythropoiesis-stimulating agent (ESA) to three times weekly
oral vadadustat dosing for the maintenance treatment of anemia. The data demonstrated that vadadustat met the primary and secondary efficacy endpoints and was non-inferior to an ESA in the treatment of anemia
due to chronic kidney disease in patients on hemodialysis when used three times a week at the time of dialysis and with a comparable safety profile to the current standard of care.
Our team has been diligent in efforts to manage spend and sustain a reduction in operating
costs, said David A. Spellman, Chief Financial Officer of Akebia. Auryxia revenue was impacted by a $5 million reduction in the volume of channel inventory from year end. We believe quarterly fluctuations in our revenue will
continue, which do not impact revenue guidance of $175-$180 million. Our team is delivering operating expense savings, with an almost 50% reduction versus the first quarter of 2022, and almost 30%
reduction from the fourth quarter of 2022. We continue to execute strategic decisions to enable us to operate with cash on hand and Auryxia revenue for at least the next twelve months.
Akebia will host a conference call on Monday, May 8 at 8:30 a.m. ET to discuss its financial results and recent business highlights. 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 http://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.
Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted
by kidney disease. Akebia 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 approved in Europe for the treatment of symptomatic anemia due to CKD in adult patients on chronic maintenance
dialysis. In Japan, vadadustat is approved as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients.
IMPORTANT SAFETY INFORMATION FOR VAFSEO (vadadustat)
For safety information, view the European Summary of Product Characteristics (SPC/SmPC) for Vafseo
IMPORTANT U.S. SAFETY
INFORMATION FOR AURYXIA (ferric citrate) CONTRAINDICATION
AURYXIA (ferric citrate) is contraindicated in patients with iron overload syndromes, e.g.,
WARNINGS AND PRECAUTIONS
Most common adverse reactions with
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 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 that Akebia submitted with the FDA to appeal the complete response letter that it received in March 2022; Akebia s expectations on the timing for certain
regulatory decisions for vadadustat by the FDA and regulatory authorities in the United Kingdom, Switzerland and Australia; Akebia s plans with respect to commercializing and completing a partnership for vadadustat in Europe; Akebia s
future plans with respect to its strategic growth and operating plans; Akebia s revenue guidance for Auryxia in 2023 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, expenses, 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 operating expenses; decisions made by health authorities, such as the FDA, with respect to regulatory filings, including the New Drug Application
and the Formal Dispute Resolution Request for vadadustat; Akebia s ability to partner for vadadustat in Europe in a timely manner, on acceptable terms, or at all; the potential therapeutic benefits, safety profile, and effectiveness of
vadadustat; the results of preclinical and clinical research; 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, 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 , Auryxia (ferric
citrate), and Vafseo (vadadustat) are registered trademarks of Akebia Therapeutics, Inc. and its affiliates.
Akebia Therapeutics Contact
| AKEBIA THERAPEUTICS, INC. | ||||||||
| Consolidated Statements of Operations | ||||||||
| (in thousands, except share and per share data) | ||||||||
| (unaudited) | ||||||||
| Three Months Ended | ||||||||
| March 31, 2023 | March 31, 2022 | |||||||
| Revenues: | ||||||||
| Product revenue, net | $ | 34,828 | $ | 41,448 | ||||
| License, collaboration and other revenue | 5,299 | 20,251 | ||||||
| Total revenues | 40,127 | 61,699 | ||||||
| Cost of goods sold: | ||||||||
| Product | 10,473 | 22,333 | ||||||
| Amortization of intangibles | 9,011 | 9,011 | ||||||
| Total cost of goods sold | 19,484 | 31,344 | ||||||
| Operating expenses: | ||||||||
| Research and development | 19,686 | 43,833 | ||||||
| Selling, general and administrative | 25,221 | 44,327 | ||||||
| License expense | 568 | 688 | ||||||
| Restructuring | 106 | |||||||
| Total operating expenses | 45,581 | 88,848 | ||||||
| Operating loss | (24,938 | ) | (58,493 | ) | ||||
| Other expense, net | (1,279 | ) | (3,928 | ) | ||||
| Net loss | $ | (26,217 | ) | $ | (62,421 | ) | ||
| Net loss per share - basic | $ | (0.14 | ) | $ | (0.35 | ) | ||
| Weighted-average number of common shares - basic | 184,768,983 | 179,599,045 |
| AKEBIA THERAPEUTICS, INC. | ||||||||
| Selected Balance Sheet Data | ||||||||
| (in thousands) | ||||||||
| (unaudited) | ||||||||
| March 31, 2023 | December 31, 2022 | |||||||
| Cash and cash equivalents | $ | 56,953 | $ | 90,466 | ||||
| Working capital | 37,775 | 60,193 | ||||||
| Total assets | 276,858 | 351,830 | ||||||
| Total stockholders (deficit) equity | (14,352 | ) | 9,342 |