Full Press Release Details
Akebia Therapeutics Reports Second Quarter 2022 Financial Results and Recent Business Highlights
Akebia to host conference call on August 4 at 4:30 p.m. ET
CAMBRIDGE, Mass. August 4, 2022 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 second quarter ended June 30, 2022 and provided business highlights.
In May we outlined the pillars of our refined strategic focus in the wake of the unexpected Complete Response Letter (CRL) for vadadustat from the FDA
to focus on driving Auryxia revenue while managing our overall spending, supporting the regulatory path for vadadustat, and thoughtfully investing in our pipeline, said John P. Butler, Chief Executive Officer of Akebia. Today we are
reporting 32.4% revenue growth for Auryxia versus the second quarter of 2021 and are increasing our revenue guidance for 2022. Since the beginning of the second quarter, we have regained the rights to vadadustat from Otsuka in the U.S., Europe, and
other territories, completed our end of review conference with the FDA, and today we shared data for vadadustat in ARDS that we believe supports further development of the drug for this indication. The progress we ve made in alignment with our
refined focus is a testament to the resilience and tenacity of the Akebia team. We look forward to continuing our progress.
The company had several
important business updates since the beginning of the second quarter 2022:
We clearly outlined our objective to manage the company with existing cash resources and ongoing
cash from operations and we are pleased to have made significant progress both in terms of net product revenue growth and cost reduction measures, said David A. Spellman, Chief Financial Officer of Akebia. Auryxia is delivering on a
growth trajectory driven by an increase in net price per pill due to an improved payor mix and improved commercial contract terms. Further, our expenses have already begun to decrease significantly as a result of our refined strategy.
A focus on our three strategic pillars have guided us to the point where we believe our existing cash resources and revenues from Auryxia will be
sufficient to fund our company s current operating plan for the next several years, said David A. Spellman, Chief Financial Officer of Akebia. With key inflection points such as a potential European approval and partnering for
vadadustat, we look forward to rebuilding in a measured way.
Akebia will host a conference call on Thursday, August 4, 2022, at 4:30 p.m. Eastern Time to discuss its second quarter financial results and provide
business updates. To listen to the conference call on August 4th, please dial (833) 630-1955 (domestic) or (412)
317-1836 (international) and ask to join into the Akebia Therapeutics call. The call will also be webcast LIVE and can be accessed via the Investors section of Akebia s website at
A replay of the conference call will be available two hours after the completion of the call through
August 10, 2022. To access the replay, dial (877) 344-7529 (domestic) or (412) 317-0088 (international) and reference replay access code 3608580. 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:
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 Akebia s response to the receipt of 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 as a treatment of ARDS due to COVID-19 and other causes; 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 the next several years. 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 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 Quarterly Report on Form 10-Q for the
quarter ended June 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
AKEBIA THERAPEUTICS, INC.
Consolidated Statements of Operations
(in thousands, except share and per share data)
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, 2022 | June 30, 2021 | June 30, 2022 | June 30, 2021 | |||||||||||||
| Revenues: | ||||||||||||||||
| Product revenue, net | $ | 43,703 | $ | 32,959 | $ | 85,151 | $ | 63,367 | ||||||||
| License, collaboration and other revenue | 83,056 | 19,954 | 103,307 | 41,850 | ||||||||||||
| Total revenues | 126,759 | 52,913 | 188,458 | 105,217 | ||||||||||||
| Cost of goods sold: | ||||||||||||||||
| Product | 9,589 | 43,484 | 31,923 | 69,079 | ||||||||||||
| Amortization of intangibles | 9,011 | 9,011 | 18,021 | 18,021 | ||||||||||||
| Total cost of goods sold | 18,600 | 52,495 | 49,944 | 87,100 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 26,027 | 37,214 | 69,860 | 77,825 | ||||||||||||
| Selling, general and administrative | 32,807 | 41,651 | 77,134 | 82,979 | ||||||||||||
| License expense | 892 | 894 | 1,580 | 1,590 | ||||||||||||
| Restructuring | 14,531 | 14,531 | ||||||||||||||
| Total operating expenses | 74,257 | 79,759 | 163,105 | 162,394 | ||||||||||||
| Operating income (loss) | 33,902 | (79,341 | ) | (24,591 | ) | (144,277 | ) | |||||||||
| Other expense, net | (4,626 | ) | (3,697 | ) | (8,554 | ) | (8,341 | ) | ||||||||
| Net income (loss) | $ | 29,276 | $ | (83,038 | ) | $ | (33,145 | ) | $ | (152,618 | ) | |||||
| Net income (loss) per share - basic | $ | 0.16 | $ | (0.51 | ) | $ | (0.18 | ) | $ | (0.97 | ) | |||||
| Weighted-average number of common shares - basic | 183,597,766 | 161,329,990 | 181,609,452 | 157,596,143 | ||||||||||||
| Net income (loss) per share - diluted | $ | 0.15 | $ | (0.51 | ) | $ | (0.18 | ) | $ | (0.97 | ) | |||||
| Weighted-average number of common shares - diluted | 190,375,317 | 161,329,990 | 181,609,452 | 157,596,143 |
AKEBIA THERAPEUTICS, INC.
Selected Balance Sheet Data
| June 30, 2022 | December 31, 2021 | |||||||
| Cash and cash equivalents | $ | 143,893 | $ | 149,800 | ||||
| Working capital | 70,483 | 15,517 | ||||||
| Total assets | 521,804 | 525,550 | ||||||
| Total stockholders equity | 62,300 | 76,456 |