Full Press Release Details
Akebia Reports Fourth Quarter and Full-Year 2020 Financial Results and Provides
CAMBRIDGE, Mass. February 25,
2021 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease, today reported financial results for the fourth quarter and full-year ended
December 31, 2020 and provided business updates. The Company will host a conference call today, Thursday, February 25, 2021, at 9:00 a.m. Eastern Time.
Akebia also announced a $60 million non-dilutive transaction with an entity managed by HealthCare Royalty
Management, LLC (HCR), to monetize the Company s rights to receive royalties and sales milestones on vadadustat net sales under its collaboration agreement with Mitsubishi Tanabe Pharma Corporation (MTPC). MTPC has the exclusive rights to
commercialize vadadustat in Japan, where it is currently marketed under the trade name Vafseo (vadadustat), and certain other Asian countries. Under the terms of the agreement with HCR, Akebia receives an upfront cash payment of
$45 million and is eligible to receive an additional $15 million if certain sales milestones are achieved. In exchange, HCR has the right to receive Vafseo royalties and sales milestones due to the Company under its collaboration agreement
with MTPC, subject to an annual cap of $13 million and an aggregate cap of $150 million. After the annual cap is met in a given calendar year, Akebia will recognize 85 percent of Vafseo royalties and sales milestones from MTPC for
that year. 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. The transaction does
not include potential future regulatory milestones to be paid by MTPC.
2020 was a year of focused execution for Akebia as we advanced vadadustat,
our investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), and executed on our commercial priorities. Importantly, we achieved this while continuing to provide patients with
access to our therapies and keeping with our goal of maintaining a strong balance sheet, stated John P. Butler, Chief Executive Officer of Akebia. With this forward momentum, we have line of sight to significant milestones in 2021,
including our NDA submission for vadadustat for the treatment of anemia due to chronic kidney disease (CKD) in both adult patients on dialysis and not on dialysis expected by the middle of the second quarter of this year.
Butler continued, As we advance vadadustat toward commercialization, subject to approval, we continue
to execute on key commercial, development, and financial priorities. As dialysis is a primary focus, we re thrilled to have recently added LeAnne Zumwalt to our Board of Directors. LeAnne s perspective and extensive operating experience
with one of the largest dialysis operators in the U.S. will help ensure that our market and commercial strategies are well aligned with the needs of dialysis providers and their patients. We re also pleased to have announced a $60 million
royalty monetization transaction with HCR that we believe strengthens our balance sheet and helps preserve both our strategic and financial flexibility while we continue investing for the successful launch of vadadustat, upon approval.
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. In addition, Akebia and its collaborator, Otsuka Pharmaceutical Co. Ltd. (Otsuka), are working in close collaboration to prepare a
Marketing Authorization Application (MAA) for submission to the European Medicines Agency (EMA), expected this year.
Recent Business Highlights:
Fourth Quarter and Full-Year 2020 Financial Results
COVID-19 continues to adversely and disproportionately impact our patient population with higher hospitalization and mortality rates, we expect this will have a negative impact on future Auryxia revenue
growth. While we are unable to fully quantify the impact of the COVID-19 pandemic on future revenues and revenue growth, we continue to work to position the Company to navigate these challenges. As such, our
financial priorities remain focused on improving our cost structure and maintaining a strong balance sheet, as evidenced by our recent $60 million non-dilutive royalty transaction with HCR, stated
David A. Spellman, Chief Financial Officer of Akebia Therapeutics.
Akebia will host a conference call at 9:00 a.m. Eastern Time today, Thursday, February 25th, to discuss its fourth quarter and full-year 2020 financial results
and recent business highlights. To listen to the conference call, please dial (877) 458-0977 (domestic) or (484) 653-6724 (international) using conference ID number
5455117. 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.
A replay of the conference call will be available two hours after the completion of the call
through March 3, 2021. To access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and reference conference ID number 5455117. An online
archive of the conference call can be accessed via the Investors section of the Company s website at http://ir.akebia.com.
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 (HIF-PH) 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 recently completed its global Phase 3 development program for the treatment of anemia due to CKD. Vadadustat is
not approved by the U.S. Food and Drug Administration (FDA) or any regulatory authority with the exception of Japan s Ministry of Health, Labour and Welfare (MHLW). In Japan, vadadustat is approved as a treatment for anemia due to CKD in both
dialysis-dependent and non-dialysis dependent adult patients.
About Anemia due to Chronic Kidney Disease (CKD)
Anemia is a condition in which a person lacks enough healthy red blood cells to carry adequate oxygen to the body s tissues. It commonly occurs
in people with CKD because their kidneys do not produce enough erythropoietin (EPO), a hormone that helps regulate production of red blood cells. 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. Left untreated, anemia leads to deterioration in health and is associated with increased morbidity and mortality in people with CKD.
IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA (ferric citrate) CONTRAINDICATION
(ferric citrate) is contraindicated in patients with iron overload syndromes, e.g., hemochromatosis.
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 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, including, but not
limited to, statements regarding: the timing of submission of an NDA to the FDA for vadadustat for the treatment of anemia due to chronic kidney disease in both adult patients on dialysis and not on dialysis; the timing of submission of a MAA for
submission to the EMA; the potential for obtaining approval of vadadustat in dialysis and non-dialysis indications; statements regarding Akebia s marketing and commercial strategies and
Ms. Zumwalt s ability to ensure alignment of such strategies with the needs of dialysis providers and their patients; Akebia s achievement of certain sales milestones and the receipt of cash payments tied thereto in
connection with the non-dilutive royalty transaction with HCR; the results that the royalty monetization agreement between Akebia and HCR has on
Akebia s balance sheet and strategic and financial flexibility; the negative impact that higher hospitalization and mortality rates due to COVID-19 in the kidney patient populations that the Company
serves had on the Company s revenue growth during the fourth quarter of 2020 and may continue to have in the future; and the timing and expectations for the Company s cash runway in relation to the expected timing of the U.S. launch of
vadadustat. The terms believe, confident, expect, plan, potential, will, and similar references are intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. 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. 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, 2020 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, INC.
Consolidated Statements of Operations
(in thousands, except share and per share data)
| Three Months Ended | Twelve Months Ended | |||||||||||||||
| December 31, 2020 | December 31, 2019 | December 31, 2020 | December 31, 2019 | |||||||||||||
| Revenues: | ||||||||||||||||
| Product revenue, net | $ | 34,604 | $ | 28,915 | $ | 128,901 | $ | 111,119 | ||||||||
| License, collaboration and other revenue | 22,095 | 40,640 | 166,406 | 223,882 | ||||||||||||
| Total revenues | 56,699 | 69,555 | 295,307 | 335,001 | ||||||||||||
| Cost of goods sold: | ||||||||||||||||
| Product | 56,026 | 29,047 | 148,866 | 108,935 | ||||||||||||
| Amortization of intangibles | 7,208 | 9,100 | 31,515 | 36,401 | ||||||||||||
| Impairment of intangible asset | 115,527 | |||||||||||||||
| Total cost of goods sold | 63,234 | 38,147 | 295,908 | 145,336 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 37,578 | 80,412 | 218,485 | 322,969 | ||||||||||||
| Selling, general and administrative | 40,311 | 44,918 | 153,947 | 149,455 | ||||||||||||
| License expense | 979 | 969 | 3,409 | 3,529 | ||||||||||||
| Total operating expenses | 78,868 | 126,299 | 375,841 | 475,953 | ||||||||||||
| Operating loss | (85,403 | ) | (94,891 | ) | (376,442 | ) | (286,288 | ) | ||||||||
| Other expense, net | (1,597 | ) | (1,344 | ) | (7,015 | ) | (2 | ) | ||||||||
| Net loss before income taxes | (87,000 | ) | (96,235 | ) | (383,457 | ) | (286,290 | ) | ||||||||
| Benefit from income taxes | (1,752 | ) | (6,631 | ) | ||||||||||||
| Net loss | $ | (87,000 | ) | $ | (94,483 | ) | $ | (383,457 | ) | $ | (279,659 | ) | ||||
| Net loss per share - basic and diluted | $ | (0.60 | ) | $ | (0.79 | ) | $ | (2.77 | ) | $ | (2.36 | ) | ||||
| Weighted-average number of common shares - basic and diluted | 145,111,415 | 119,358,081 | 138,463,152 | 118,395,919 |
AKEBIA THERAPEUTICS, INC.
Selected Balance Sheet Data
| December 31, 2020 | December 31, 2019 | |||||||
| Cash, cash equivalents and available for sale securities | $ | 268,690 | $ | 147,694 | ||||
| Working capital | 184,291 | 101,415 | ||||||
| Total assets | 644,139 | 771,201 | ||||||
| Total stockholders equity | 247,618 | 394,757 |