Full Press Release Details
Akebia Therapeutics Reports Second Quarter 2019 Financial Results and Hosts Conference Call to
Discuss Recent Business Highlights
CAMBRIDGE, Mass. August 8, 2019 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company focused on the development and
commercialization of therapeutics for people living with kidney disease, today reported financial results for the second quarter ended June 30, 2019. The Company will host a conference call today, Thursday, August 8, 2019, at 9:00 a.m.
Eastern Time to discuss its second quarter 2019 financial results and recent business highlights.
Akebia continues to make great progress advancing
our strategy. Fueled by strong operational execution, we increased Auryxia revenue by 21 percent compared to the same period last year and reinforced the strength of our Auryxia intellectual property with an important ANDA settlement. We also
achieved significant milestones with our development program for vadadustat, including a JNDA submission that we believe may establish vadadustat as the first oral hypoxia-inducible factor prolyl hydroxylase inhibitor
(HIF-PHI) to file for regulatory approval for the treatment of anemia due to chronic kidney disease (CKD) in both dialysis dependent and non-dialysis dependent adult
patients in a major market, stated John P. Butler, President and Chief Executive Officer of Akebia. While there is still much work ahead of us, we remain confident and believe we have tremendous opportunities to advance our mission to
better the lives of people with kidney disease and deliver significant value to all our stakeholders. We ve been very purposeful in developing our strategy, and it s great to see the benefits of our work coming to light as the team
continues to systematically execute on our priorities.
Butler continued, We re excited by the opportunities to continue advancing
Auryxia s long-term growth story. The 26 percent sequential revenue growth we achieved over the first quarter demonstrates that the team is successfully executing against our near-term growth initiatives. The prescription demand that
we ve seen in the first four weeks of the third quarter is the highest of any quarter since Auryxia was launched, affirming our confidence that Auryxia is on a solid growth trajectory. We
believe continued progress on our growth initiatives and underlying market demand will drive increased revenue for Auryxia across the second half of the year.
Vadadustat Highlights
Total revenue for the second quarter
of 2019 was $100.8 million, compared to $48.8 million in the second quarter of 2018.
Auryxia net product revenue for the second quarter of 2019
was $29.1 million, compared to $24.1 million, as reported by Keryx Biopharmaceuticals, Inc. (Keryx) prior to its merger with the Company, during the same period in 2018. This represents a 20.7 percent increase in net product revenue
from the second quarter of 2018 and a 26 percent increase compared to the first quarter of 2019. Auryxia is the Company s FDA approved oral iron tablet to treat non-dialysis dependent adult CKD
patients for IDA and dialysis-dependent adult CKD patients for hyperphosphatemia.
Collaboration revenue for the second quarter of 2019 was
$71.7 million, compared with $48.8 million in the second quarter of 2018. The increase was primarily due to increased collaboration revenue of $11.4 million from Otsuka Pharmaceutical Co. Ltd (Otsuka), and $10.0 million from MTPC
in accordance with the Company s collaboration agreements. Otsuka began funding 80 percent of the development costs for vadadustat in the second quarter of 2019.
Cost of goods sold was $37.7 million for the second quarter of 2019, consisting of $9.6 million of costs associated with the manufacture of Auryxia
and non-cash charges of $28.1 million related to the application of purchase accounting as a result of the merger with Keryx. These non-cash, merger-related charges
include a $19.0 million inventory step-up charge and $9.1 million of amortization of intangibles.
Research and development expenses were $85.7 million for the second quarter of 2019 compared to $71.9 million for the second quarter of 2018. The
increase was primarily attributable to an increase in external costs related to the continued advancement of the PRO2TECT and INNO2VATE
Phase 3 studies of vadadustat as well as increases in headcount to support our research and development programs.
Selling, general and administrative
expenses were $36.1 million for the second quarter of 2019 compared to $12.5 million for the second quarter of 2018. The increase in selling, general and administrative expenses was primarily attributable to commercialization costs
associated with Auryxia, as there were no comparable commercialization costs in the second quarter of 2018.
The Company reported a net loss for the second quarter of 2019 of $58.2 million, or ($0.49) per share,
as compared to a net loss of $34.1 million, or ($0.60) per share, for the second quarter of 2018. The Company s net loss for the second quarter of 2019 includes the impact of non-cash charges of
$28.1 million related to the application of purchase accounting as a result of the merger with Keryx.
The Company ended the quarter with cash, cash
equivalents and available-for-sale securities of $136.8 million. As we continue to effectively manage and leverage our operations, we
expect our cash resources, including committed research and development funding from collaborators, to fund our current operating plan beyond the next twelve months, into the third quarter of 2020, stated Jason A. Amello, Chief Financial
a conference call today, Thursday, August 8, 2019, at 9:00 a.m. Eastern Time to discuss its second quarter 2019 financial results and recent business updates. To listen to the conference call, please dial (877)
458-0977 (domestic) or (484) 653-6724 (international) using conference ID number 7274126. 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 August 14, 2019. To access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and reference conference
ID number 7274126. An online archive of the conference call can be accessed via the Investors section of the Company s website at http://ir.akebia.com.
About Akebia Therapeutics
Akebia Therapeutics,
Inc. is a fully integrated biopharmaceutical company focused on the development and commercialization of therapeutics for people living with 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 currently in global Phase 3 development for the treatment of anemia due to CKD.
Vadadustat s proposed mechanism of action is designed to mimic the physiologic effect of altitude on oxygen availability. At higher altitudes, the body responds to lower oxygen availability with increased production of hypoxia-inducible factor,
which coordinates the interdependent processes of iron mobilization and erythropoietin production to increase red blood cell production and, ultimately, improve oxygen delivery. Vadadustat is an investigational therapy and is not approved by
the U.S. Food and Drug Administration (FDA) or any regulatory authority.
Auryxia (ferric citrate) Tablets
Auryxia (ferric citrate) was approved by
the FDA on September 5, 2014 for the control of serum phosphorus levels in adult patients with CKD on dialysis and approved by the FDA on November 6, 2017 for the treatment of iron deficiency anemia in adult
patients with CKD not on dialysis. For more information about Auryxia and the U.S. full prescribing information, please visit www.auryxia.com.
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
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 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 potential benefits of vadadustat; the potential for the JNDA filing for vadadustat to form the basis of a launch, if approved; the rate and timing of enrollment of our clinical trials; the potential benefits of
the combined company post-merger; the market and growth potential of Auryxia, including expectations related to an increase in revenue; the anticipated timing of the availability and reporting of clinical trial data and results; management and key
personnel changes and transitional periods; potential and anticipated payments from our collaborators, including the timing thereof; management and leverage of operations and resources dedicated thereto; continued funding and advancement of
development efforts; and expectations regarding financial position, including the period of time cash resources (including committed research and development funding from our collaborators) will fund our current operating plan. The terms
anticipate, believe, expect, opportunity, planned, potential, target, 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 the rate of enrollment in clinical studies of vadadustat; risks associated with market acceptance and coverage and reimbursement of Auryxia; the risks associated with potential generic entrants for Auryxia; the rate of major adverse
cardiovascular events in our global phase 3 clinical trials for vadadustat; the risk that clinical trials may not be successful; the risk that existing preclinical and clinical data may not be predictive of the results of ongoing or later clinical
trials; manufacturing risks; the quality and manner of the data that will result from clinical studies of vadadustat; risks associated with management and key personnel changes and transitional periods; the actual funding required to develop and
commercialize Akebia s product candidates and operate the company, and the actual expenses
associated therewith; the actual costs incurred in the clinical studies of vadadustat and the availability of financing to cover such costs; the risk that clinical studies are discontinued or
delayed for any reason, including for safety, tolerability, enrollment, manufacturing or economic reasons; early termination of any of Akebia s collaborations; Akebia s and its collaborators ability to satisfy their obligations under
Akebia s collaboration agreements; the timing and content of decisions made by regulatory authorities; the timing of any additional studies initiated for vadadustat; the actual time it takes to initiate and complete preclinical and clinical
studies; the competitive landscape for Auryxia and vadadustat; the scope, timing, and outcome of any ongoing legal, regulatory and administrative proceedings; changes in the economic and financial conditions of the businesses of Akebia and its
partners; the risk that we lose, or settle on less favorable terms, other ANDA litigation, or that other ANDA filers enter the market earlier than March 20, 2025, as well as any other potential settlements; and Akebia s ability to obtain,
maintain and enforce patent and other intellectual property protection for Auryxia, 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 quarterly period ended March 31, 2019 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 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 | Six Months Ended | |||||||||||||||
| June 30, 2019 | June 30, 2018 | June 30, 2019 | June 30, 2018 | |||||||||||||
| Revenues: | ||||||||||||||||
| Product revenue, net | $ | 29,089 | $ | $ | 52,200 | $ | ||||||||||
| License, collaboration and other revenue | 71,714 | 48,793 | 121,269 | 94,723 | ||||||||||||
| Total revenues | 100,803 | 48,793 | 173,469 | 94,723 | ||||||||||||
| Cost of goods sold: | ||||||||||||||||
| Product | 28,569 | 50,726 | ||||||||||||||
| Amortization of intangibles | 9,100 | 18,200 | ||||||||||||||
| Total cost of goods sold | 37,669 | 68,926 | ||||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 85,694 | 71,917 | 168,045 | 133,321 | ||||||||||||
| Selling, general and administrative | 36,068 | 12,538 | 70,359 | 21,562 | ||||||||||||
| License expense | 895 | 1,631 | ||||||||||||||
| Total operating expenses | 122,657 | 84,455 | 240,035 | 154,883 | ||||||||||||
| Operating loss | (59,523 | ) | (35,662 | ) | (135,492 | ) | (60,160 | ) | ||||||||
| Other income, net | 508 | 1,593 | 1,299 | 2,673 | ||||||||||||
| Net loss before income taxes | (59,015 | ) | (34,069 | ) | (134,193 | ) | (57,487 | ) | ||||||||
| Benefit from income taxes | (845 | ) | (3,602 | ) | ||||||||||||
| Net loss | $ | (58,170 | ) | $ | (34,069 | ) | $ | (130,591 | ) | $ | (57,487 | ) | ||||
| Net loss per share basic and diluted | $ | (0.49 | ) | $ | (0.60 | ) | $ | (1.11 | ) | $ | (1.09 | ) | ||||
| Weighted-average number of commons shares basic and diluted | 118,268,832 | 56,890,295 | 117,669,422 | 52,774,794 |
AKEBIA THERAPEUTICS, INC.
Selected Balance Sheet Data
| June 30, 2019 | December 31, 2018 | |||||||
| Cash, cash equivalents and available for sale securities | $ | 136,765 | $ | 321,640 | ||||
| Working capital | 130,778 | 202,582 | ||||||
| Total assets | 823,528 | 996,540 | ||||||
| Total stockholders equity | 519,356 | 635,928 |