On November 3, 2022 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 third quarter ended September 30, 2022 and provided business highlights (Press release, Akebia, NOV 3, 2022, View Source [SID1234622981]).
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"Our team continues to execute a strategy aligned with our three strategic pillars, drive Auryxia revenue while managing costs, support the regulatory processes for vadadustat globally, and thoughtfully invest in our pipeline," said John P. Butler, Chief Executive Officer of Akebia. "Our team is leading the regulatory review of vadadustat in Europe and select ACCESS markets. Between those review processes and the submission of a request for formal dispute resolution with the FDA regarding the Complete Response Letter for vadadustat in the U.S., we anticipate the fourth quarter could bring some clarity and a timeframe for our ability to potentially obtain approval for vadadustat in various markets."
In October 2022, Akebia submitted a Formal Dispute Resolution Request (FDRR) with the U.S. Food & Drug Administration (FDA) regarding the Complete Response Letter (CRL) received in March 2022 for vadadustat, which was under review as a treatment for anemia due to chronic kidney disease (CKD). The FDRR focuses on the favorable balance of the benefits and risks of vadadustat for the treatment of anemia due to CKD in adult patients on dialysis in light of safety concerns expressed by the FDA in the CRL related to the rate of adjudicated thromboembolic events driven by vascular access thrombosis for vadadustat compared to the active comparator and the risk of drug-induced liver injury. Based on the typical FDRR process, Akebia expects to receive a response to its submission by the end of 2022.
"We act in the interest of patients impacted by kidney disease and believe in the favorable balance of the benefits and risks of vadadustat as a treatment for anemia due to chronic kidney disease," said John P. Butler, Chief Executive Officer of Akebia. "To that end, we are continuing to pursue a path that could potentially lead to an approval of vadadustat for dialysis dependent patients in the U.S."
The company had additional important business updates since the beginning of the third quarter of 2022:
Akebia assumed responsibility from Otsuka Pharmaceuticals Co. Ltd. (Otsuka) for the marketing authorization application (MAA) for vadadustat that Otsuka submitted to the European Medicines Agency (EMA). Based on the current review timeline, Akebia expects a decision on the MAA from EMA in the first quarter of 2023.
Akebia continued to strengthen its balance sheet position by retiring $33 million of its $100 million debt facility with Pharmakon, inclusive of the first quarterly principal repayment.
In August 2022, Akebia released initial findings from an investigator-sponsored clinical study with the University of Texas Health Sciences Center, Houston (UTHealth) evaluating vadadustat for the prevention and treatment of acute respiratory distress syndrome (ARDS). Akebia has since further collaborated with UTHealth to begin outlining potential next steps associated with an ARDS development program.
"Managing operating expenses is critical as we look for opportunities to add value to the company," said David A. Spellman, Chief Financial Officer of Akebia. "By focusing on operating expenses and winding down certain projects, we’re pleased to report a reduction in spend quarter over quarter in 2022. Auryxia net product revenue increased in the third quarter of 2022 from the third quarter of 2021. There was a slight decline from the second quarter of 2022 partially due to the drawdown of inventory at certain customers during the third quarter of 2022. In addition, since the start of COVID, the phosphate binder market has contracted 15%. While the phosphate binder market has continued to decline, the work we’ve done to increase net price per pill puts us in a position to affirm our 2022 net product revenue guidance for Auryxia of $170 – $175 million."
Financial Results
Revenues: Total revenue was $49.0 million in the third quarter of 2022 compared to $48.8 million for the third quarter of 2021.
Net product revenue was $42.2 million in the third quarter of 2022 compared to $36.8 million in the third quarter of 2021, a 14.9% increase; and compared with $43.7 million in the second quarter of 2022, a 3.3% decrease. The increase compared to the third quarter of 2021 is primarily due to pricing and improved payer mix. The decrease compared to the second quarter of 2022 was due to a reduction in inventory drawdowns of Auryxia by certain customers.
License, collaboration and other revenue was $6.7 million in the third quarter of 2022 compared to $12.0 million in the third quarter of 2021. The decrease was primarily related to a reduction in revenue from the termination of the U.S. and international collaboration agreements between Akebia and Otsuka in the second quarter of 2022.
COGS: Cost of goods sold was $37.9 million in the third quarter of 2022 compared to $15.9 million in the third quarter of 2021. The increase compared to the prior year period was primarily due to a $13.2 million non-cash charge related to an increase in the liability for excess purchase commitments during the third quarter of 2022 and a $6.0 million non-cash benefit related to a decrease in the liability for excess purchase commitments in the third quarter of 2021 which did not reoccur.
R&D Expenses: Research and development expenses were $27.4 million in the third quarter of 2022 compared to $40.5 million in the third quarter of 2021. The decrease compared to the prior year period was primarily due to decreased headcount related costs due to the previously announced reduction in force and decreased clinical trial costs.
SG&A Expenses: Selling, general and administrative expenses were $30.9 million in the third quarter of 2022 compared to $46.4 million in the third quarter of 2021. The decrease compared to the prior year period was primarily due to decreased headcount related costs as a result of the reduction in force, lower one-time legal costs, and lower marketing expenses.
Net Loss: Net loss was $51.9 million in the third quarter of 2022 compared to $59.5 million in the third quarter of 2021.
Cash Position: Cash and cash equivalents as of September 30, 2022 were $144.8 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 includes assumptions pertaining to cost avoidance measures and the reduction of overhead costs resulting from the planned amendment of contractual arrangements with certain supply partners, and the reduction of operating expenses. The outcome of these assumptions, such as the potential amendment of contractual arrangements with certain supply partners, are outside of Akebia’s control. In addition, future decisions by the FDA or other regulatory agencies related to the potential regulatory approval of vadadustat or our ability to generate additional value from vadadustat through partnerships or other transactions may potentially further extend our cash runway, but such future decisions or transactions are not contemplated in our operating plan.
Conference Call
Akebia will host a conference call on November 3 at 4:30 p.m. ET to discuss its financial results and recent company highlights. Access to the call will be provided via a new process. 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.