On November 7, 2024 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, 2024, and recent business highlights (Press release, Akebia, NOV 7, 2024, View Source [SID1234647900]). During the quarter, Akebia continued to execute on the commercial launch of Vafseo (vadadustat) to prepare for U.S. market availability expected in January 2025.

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"Our entire organization has been diligently executing across multiple fronts on launch readiness activities as we approach Vafseo U.S. market availability expected in January. Importantly, approximately 60 percent of patients on dialysis are now covered under dialysis organization and group purchasing organization contracts for Vafseo," said John P. Butler, Chief Executive Officer of Akebia. "We expect to enter into contracts with additional dialysis providers to increase coverage over the remainder of 2024 while continuing our efforts to drive demand for Vafseo from prescribers. We also recently partnered with U.S. Renal Care (USRC) to initiate a collaborative trial evaluating mortality and hospitalization outcomes for dialysis patients taking Vafseo to further add to Vafseo’s body of clinical evidence, and separately presented six posters with Vafseo clinical data at the recent American Society of Nephrology (ASN) Kidney Week conference. Taken together, these initiatives are intended to continue to support a strong launch and move toward establishing Vafseo as the new oral standard of care for dialysis patients with anemia."
Progress on Key Vafseo Business Initiatives
•Akebia has entered into commercial supply contracts for Vafseo with dialysis organizations treating over 300,000 patients, which represents approximately 60% of dialysis patients in the U.S. Recent commercial supply contracts include agreements with one of the leading dialysis organizations serving more than 200,000 dialysis patients, USRC which serves more than 36,000 patients and Renal Purchasing Group, a specialty group purchasing organization that serves many of the independent and small dialysis organizations.

•In October 2024, the Center for Medicare & Medicaid Services determined that Vafseo met the criteria for Transitional Drug Add-On Payment Adjustment (TDAPA) reimbursement, which will begin on January 1, 2025. Akebia also received a Level II Healthcare Common Procedure Coding System code for Vafseo that will be utilized by dialysis organizations to help process health insurance claims for Medicare enrollees upon launch.

•In October 2024, Akebia had a strong presence at the ASN Kidney Week conference, hosting commercial and medical affairs booths, and a product theatre, as well as presenting seven scientific posters at the conference. The event was well-attended with significant participation from the nephrology community serving to help Akebia further educate the physician community and to drive prescriber demand in advance of Vafseo market availability.

•In September 2024, Akebia and USRC initiated the Vafseo Outcomes In-Center Experience (VOICE) trial. The trial will randomize patients to treatment with oral Vafseo 300 mg tablets administered three times per week or standard of care erythropoiesis-stimulating agents and will be powered to demonstrate non-inferiority for all-cause mortality and superiority for a 10% reduction in all-cause hospitalization.
Financial Results
•Revenues: Total revenues were $37.4 million in the third quarter of 2024 compared to $42.0 million for the third quarter of 2023, comprised of the following components:

▪Auryxia (ferric citrate) net product revenues were $35.6 million in the third quarter of 2024 as compared to $40.1 million in the third quarter of 2023. This decrease was driven by a reduction in volume partially offset by price increases and execution of our contracting strategy with third party payors. Akebia continues to enter into commercial supply contracts for Auryxia, which is expected to be added to the bundled payment for dialysis services in January 2025.

▪License, collaboration and other revenues were $1.8 million in the third quarter of 2024 compared to $1.9 million in the third quarter of 2023.

•Cost of Goods Sold: Cost of goods sold (COGS) was $14.2 million in the third quarter of 2024 compared to $18.0 million in the third quarter of 2023. This decrease was driven by a $3.7 million benefit due to our ability to commercially sell inventory previously written-down as excess inventory, as well as lower year-over-year sales volume. Akebia continues to carry a non-cash intangible amortization charge of $9.0 million per quarter in COGS through the fourth quarter of 2024.

•Research & Development Expenses: Research and development expenses were $8.5 million in the third quarter of 2024 compared to $13.3 million in the third quarter of 2023. This decrease was driven by the completion of activities related to certain clinical trials, lower headcount related costs and decreased professional service and consulting expense.

•Selling, General & Administrative Expenses: Selling, general and administrative expenses were $26.5 million in the third quarter of 2024 compared to $22.7 million in the third quarter of 2023. This increase was driven by higher costs incurred in connection with preparatory activities related to Vafseo product availability in the U.S., which is expected in January 2025.

•Net Loss: Net loss was $20.0 million in the third quarter of 2024 compared to $14.5 million in the third quarter of 2023. The increase in net loss included $4.4 million in non-cash interest expense related to the settlement royalty liability in connection with the Vifor Termination and Settlement Agreement that Akebia signed in July 2024.

•Cash Position: Cash and cash equivalents as of September 30, 2024 were approximately $34.0 million. Akebia expects its existing cash resources and cash from operations will be sufficient to fund its current operating plan, including the U.S. Vafseo launch, for at least two years.

Conference Call
Akebia will host a conference call on Thursday, November 7 at 8:00 a.m. Eastern Time to discuss third quarter 2024 earnings. 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.