On November 8, 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 third quarter ended September 30, 2023 and reviewed recent business highlights (Press release, Akebia, NOV 8, 2023, View Source [SID1234637240]).

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In September, Akebia completed its resubmission to its New Drug Application for vadadustat to the U.S. Food and Drug Administration (FDA) as a treatment for anemia due to chronic kidney disease (CKD) in adult patients on dialysis. FDA subsequently accepted the resubmission and assigned a user fee goal date ("PDUFA date") of March 27, 2024. The resubmission includes post-marketing safety data from tens of thousands of patients in Japan where vadadustat is approved and has been in the market for more than three years.

"Akebia is extremely well-positioned following the acceptance of our vadadustat NDA resubmission, with a March 27, 2024 PDUFA date," said John P. Butler, Chief Executive Officer of Akebia. "We are preparing for a commercial launch if vadadustat is approved and stand ready with a commercial team in place and product supply on the shelf. We also added Australia and Taiwan to the list of countries where vadadustat is approved for CKD patients on dialysis. Additionally, we have strengthened our financial position by deferring our Pharmakon principal payments until October 2024."

Auryxia (ferric citrate) net product revenue for the third quarter was $40.1 million and management reaffirms previously issued 2023 net product revenue guidance of $170.0 – $175.0 million for Auryxia.

Third Quarter 2023 and Recent Business Highlights

•Australia’s Therapeutic Goods Administration granted approval for Vafseo (vadadustat) for the treatment of anemia associated with CKD in adults on chronic maintenance dialysis. Vadadustat was also authorized for use in Taiwan during this time, marking approval in 36 countries.
•Akebia supported five posters presented at the American Society of Nephrology Kidney Week 2023, which took place on November 2-5, 2023. Notably, one poster presented data on a potential alternative dosing regimen for vadadustat.
•Akebia modified the terms of its loan agreement with Pharmakon Advisors, LP to extend the maturity of the loan from November 2024 until March 2025, and to defer its principal payments until October 31, 2024.

Third Quarter Financial Results

Total Revenues: Total revenues were $42.0 million for the third quarter of 2023, compared to $48.7 million for the third quarter of 2022. The decrease is primarily due to a decrease in license, collaboration and other revenue.

Net Product Revenues: Net product revenues were $40.1 million for the third quarter of 2023, compared to $42.0 million for the third quarter of 2022. The decrease was primarily due to a reduction in volume and the impact of shifting payor mix, partially caused by contracting dynamics and a decline in the phosphate binder market. The decline was partially offset by price increases in January 2023 and July 2023.

License, Collaboration and Other Revenues: License, collaboration and other revenues were $1.9 million for the third quarter of 2023, compared to $6.7 million for the third quarter of 2022. The decrease is primarily due to the transfer and assignment of a supply agreement to Akebia’s collaboration partner.

Cost of Goods Sold (COGS): COGS was $18.0 million for the third quarter of 2023, compared to $38.3 million for the third quarter of 2022. COGS reflects the costs of Auryxia, including non-cash intangible amortization charge of $9.0 million per quarter through the fourth quarter of 2024 and third-party royalties. The decrease was primarily due to a reduction in a non-cash charge related to the prior liability for excess purchase commitments, a decrease in inventory write-downs and lower volume of sales resulting in reduced product costs.

Research and Development (R&D) Expenses: R&D expenses were $13.3 million for the third quarter of 2023, compared to $28.0 million for the third quarter of 2022. The decrease was primarily due to a reduction in spending for vadadustat development, including clinical trial costs, and curtailment of outsourced contract services.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses were $22.7 million for the third quarter of 2023, compared to $31.9 million for the third quarter of 2022. The decrease was primarily due to a reduction in headcount related costs, the benefits realized from the assignment of the Boston lease in May 2023 and a targeted cutback in Auryxia marketing and promotional expense which were offset by some one-time non-recurring expenses.

Net Loss: Net loss was $14.5 million for the third quarter of 2023, compared to net loss of $54.1 million for the third quarter of 2022.

Cash Position: Cash, cash equivalents and restricted cash as of September 30, 2023, totaled $48.2 million. Akebia expects its existing cash resources and cash from operations will be sufficient to fund its current operating plan for at least the next twelve months.

Conference Call Information

Akebia will host a conference call and webcast on Wednesday, November 8 at 8:00 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 you will be provided with dial in details. To avoid delays and ensure timely connection, we encourage dialing into the conference call 15 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/." target="_blank" title="View Source/." rel="nofollow">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.