On March 9, 2023 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported financial results for the fourth quarter and full-year ended December 31, 2022 and provided business highlights (Press release, Akebia, MAR 9, 2023, View Source [SID1234628390]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We ended our year delivering on our strategic focus, which included a commitment to maximize Auryxia revenue, support vadadustat globally and thoughtfully invest in our pipeline," said John P. Butler, Chief Executive Officer of Akebia. "We believe the work our team executed through the fourth quarter and more broadly in 2022 has put us in a strong position as we prepare for several meaningful upcoming milestones. Building on our positive CHMP opinion for vadadustat in Europe, we anticipate potential Marketing Authorization of Vafseo by the European Commission in May 2023, and we are active in our process to select a partner in Europe to deliver Vafseo to patients with chronic kidney disease (CKD) on dialysis, if approved."
Last month, Akebia announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the European Commission (EC) to approve Vafseo (vadadustat), for the treatment of symptomatic anaemia associated with CKD in adults on chronic maintenance dialysis. If approved, an EC Marketing Authorization of Vafseo would be applicable to all 27 European Union member states plus Iceland, Norway and Liechtenstein. Akebia is seeking a partner to commercialize vadadustat in Europe.
Additionally, Akebia had an important year with several key milestones in 2022 and into early 2023
Achieved Auryxia revenue of $177.1 million representing 24.5% growth versus 2021
Implemented multiple initiatives to reduce costs and create a clear path to positive cash flows from operations supported by Auryxia revenues
Restructured and simplified the Auryxia supply chain, saving significant anticipated cash over a five-year period
Signed a European license agreement with Averoa SAS for the development and commercialization of Auryxia in Europe
Regained the rights from Otsuka Pharmaceutical Co. Ltd. for vadadustat in the U.S., Europe, China, Russia, Canada, Australia, the Middle East, and certain other territories
Assumed responsibility for vadadustat regulatory filings in EMA and ACCESS Consortium countries: U.K., Switzerland and Australia
Submitted a Formal Dispute Resolution Request (FDRR) to the U.S. Food and Drug Administration (FDA), disputing the Complete Response Letter (CRL) for vadadustat received in March 2022; and
Released data from an investigator-sponsored clinical study with the University of Texas Health Sciences Center, Houston (UT Health), evaluating vadadustat for the prevention and treatment of COVID-19 related acute respiratory distress syndrome (ARDS).
Pipeline Progress Expected in 2023
Obtain potential Marketing Authorization for Vafseo expected in Europe in May 2023
Receive regulatory decision for vadadustat for U.K., Switzerland and Australia
Receive decision on appeal process related to CRL for vadadustat
Present data from the IMPACT investigator-sponsored study evaluating the effect of Auryxia as a phosphate binder on utilization of IV iron and erythropoiesis-stimulating agents on dialysis patients
Present data from the FOCUS study on three times weekly dosing for vadadustat in dialysis patients
Initiate UT Health study of vadadustat for the prevention and treatment of ARDS in a broader population beyond patients with COVID-19
Assess potential regulatory path for vadadustat in other acute treatment indications; and
Advance preclinical development of multiple novel hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor compounds for potential indications of serious unmet need.
"Auryxia revenue continues to fund our business, and we entered 2023 with a robust operating plan, including funding for several compelling pipeline opportunities," said David A. Spellman, Chief Financial Officer of Akebia. "Regarding revenue, we reported nearly 25% net product revenue growth for Auryxia over 2021, which exceeded guidance. The fourth quarter of 2022 included an inventory build of approximately $3M year over year. We have set 2023 net product revenue guidance at $175-180 million as we remain cautious about a phosphate binder market recovery; the market continues to contract modestly due to COVID-19 and dialysis staffing issues. We will continue to be mindful of non-essential spend and work to reduce costs overall."
Financial Results
Revenues: Total revenue was $55.2 million in the fourth quarter of 2022 compared to $59.6 million for the fourth quarter of 2021, and $292.6 million for the full-year 2022 compared to $213.6 million for full-year 2021
Net product revenue was $49.7 million in the fourth quarter of 2022 compared to $42.1 million in the fourth quarter of 2021, an 18.1% increase. Net product revenue was $177.1 million for the full-year 2022 compared to $142.2 million for the full-year 2021, an increase of approximately 24.5%. The increase compared to the fourth quarter and full-year of 2021 is primarily due to pricing and improved payer mix, and a 2022 year-end inventory build by a customer that exceeded 2021. Total units sold decreased year over year
License, collaboration, and other revenue was $5.5 million for the fourth quarter of 2022 compared to $17.5 million for the fourth quarter of 2021, and $115.5 million for the full-year 2022 compared with $71.4 million for the full-year 2021. The increase for the full-year 2022 reflects a nonrefundable and non-creditable payment of $55.0 million that Otsuka paid to Akebia in July 2022 under the terms of a termination and settlement agreement between the companies. In addition, Akebia recognized $15.5 million related to previously deferred revenue as of the date of termination and $9.6 million of non-cash consideration related to Otsuka’s obligations to complete certain agreed upon clinical activities. Additionally, Akebia recognized $19.1 million in collaboration revenue in 2022 from the cost sharing arrangement with Otsuka prior to the termination, compared to $53.0 million for the full-year 2021
Auryxia revenue guidance for 2023 of $175—$180 million assumes, among other things, an increase in realized net price per pill, partially offset by a reduction in total units sold and inventories returning to normal levels
COGS: Cost of goods sold was a benefit of $3.1 million for the fourth quarter of 2022 compared to a cost of $50.4 million for the fourth quarter of 2021. Cost of goods sold was $84.8 million for the full-year 2022, compared with $153.4 million for the full-year 2021. The decrease in both periods compared to the same periods in 2021 was primarily due to a non-cash reduction of our excess purchase commitment liability driven by the reduction in purchase commitments with the restructuring of our supply chain. The decrease was partially offset by contract termination fees and inventory reserves associated with Auryxia drug substance that will not be forward processed
R&D Expenses: Research and development expenses were $31.9 million for the fourth quarter of 2022 compared to $29.6 million for the fourth quarter of 2021, and $129.1 million for the full-year 2022 compared to $147.9 million for the full-year 2021. The increase for the fourth quarter of 2022 compared to the fourth quarter of 2021 was largely due to a one-time credit of $8.6 million representing a reimbursement from Vifor Pharma following the sale of the Priority Review Voucher that occurred in 2021. The decrease for the full-year 2022 compared to the full-year 2021 was primarily due to decreased headcount related costs as a result of the April 2022 reduction in force, decreased consulting costs, and decreased outsourced contract services
SG&A Expenses: Selling, general and administrative expenses were $30.6 million for the fourth quarter of 2022 compared to $44.8 million for the fourth quarter of 2021, and $138.7 million for the full-year 2022 compared to $174.2 million for the full-year 2021. The decrease in both periods compared to the same periods in 2021 was primarily due to decreased headcount related costs as a result of both the April 2022 and November 2022 reductions in force, decreased one-time legal costs, and lower marketing expenses following receipt of the CRL for vadadustat
Net Loss: Net loss was $7.6 million for the fourth quarter of 2022 compared to $70.7 million for the fourth quarter of 2021, and $92.6 million for the full-year 2022 compared to $282.8 million for the full-year 2021. The decrease in net loss for the full-year 2022 compared to the prior year was due primarily to higher revenues, lower cost of goods sold and lower operating expenses, partially offset by restructuring expenses in 2022
Cash Position: Cash and cash equivalents as of December 31, 2022 were $90.5 million. Akebia believes that its cash resources will be sufficient to fund its current operating plan for at least the next twelve months. Akebia’s operating plan assumed certain contractual changes and cost avoidance measures would be executed over the course of 2022, which has now occurred. Akebia’s objective is to fund its current operating plan with existing cash resources and cash from operations for at least the next twelve months. Future decisions by the FDA or other regulatory agencies related to the potential regulatory approval of vadadustat, or Akebia’s ability to generate additional value from vadadustat through partnerships or other transactions, may potentially further extend our cash runway, but are not currently reflected in the operating plan. Akebia also plans to continue to work on initiatives to extend its revenues from Auryxia beyond the anticipated loss of exclusivity in March 2025.
Conference Call
Akebia will host a conference call on Thursday, March 9 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: View Source An online archive of the webcast can be accessed via the Investors section of Akebia’s website at View Source approximately two hours after the event.