Akebia Therapeutics Inc (AKBA) Q4 2024 Earnings Call Highlights: Navigating Revenue Declines ...

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  • Total Revenue: $46.5 million in Q4 2024, down from $56.2 million in Q4 2023.
  • Full-Year Revenue: $160.2 million in 2024, down from $194.6 million in 2023.
  • Auryxia Net Product Revenue: $44.4 million in Q4 2024, down from $53.2 million in Q4 2023; $152.2 million in 2024, down from $170.3 million in 2023.
  • License, Collaboration, and Other Revenue: $2.1 million in Q4 2024, down from $3 million in Q4 2023; $8 million in 2024, down from $24.3 million in 2023.
  • Cost of Goods Sold: $20.4 million in Q4 2024, up from $18.7 million in Q4 2023; $63.2 million in 2024, down from $74.1 million in 2023.
  • R&D Expenses: $11.8 million in Q4 2024, up from $9.9 million in Q4 2023; $37.7 million in 2024, down from $53.1 million in 2023.
  • SG&A Expenses: $27.7 million in Q4 2024, up from $25.4 million in Q4 2023; $106.5 million in 2024, up from $100.2 million in 2023.
  • Net Loss: $22.8 million in Q4 2024, compared to net income of $0.6 million in Q4 2023; $69.4 million in 2024, up from $51.9 million in 2023.
  • Cash and Cash Equivalents: $51.9 million as of December 31, 2024, up from $42.9 million as of December 31, 2023.
  • Vafseo Net Product Revenue (Q1 2025 Estimate): Expected between $10 million and $11 million.
  • Warning! GuruFocus has detected 5 Warning Signs with AKBA.

Release Date: March 13, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

  • Akebia Therapeutics Inc (NASDAQ:AKBA) reported strong early demand for Vafseo, with expected net product revenue between $10 million and $11 million for Q1 2025, exceeding analyst estimates.
  • The company has secured commercial supply contracts with dialysis providers covering nearly 100% of dialysis patients in the US, facilitating broad access to Vafseo.
  • Over 500 physicians have prescribed Vafseo since its launch, with an average of approximately eight prescriptions each, indicating strong initial prescriber engagement.
  • Positive early feedback from physicians and strong participation in peer-to-peer programs suggest high interest and potential for Vafseo to become a standard of care.
  • Akebia Therapeutics Inc (NASDAQ:AKBA) has a robust distribution network that has helped manage initial prescription backlogs, ensuring better access to Vafseo for patients.

Negative Points

  • Total revenues for Q4 2024 decreased to $46.5 million from $56.2 million in Q4 2023, reflecting a decline in Auryxia net product revenues.
  • The company reported a net loss of $22.8 million in Q4 2024 compared to net income of $0.6 million in Q4 2023, impacted by lower revenues and non-cash interest expenses.
  • There is a backlog in prescription fulfillment for Vafseo and other TDAPA products, with some delays exceeding three weeks, affecting patient access.
  • The transition of prescriptions to specialty pharmacies has caused operational challenges, impacting the timely delivery of Vafseo to patients.
  • The company does not plan to provide quarterly revenue guidance going forward, which may limit visibility for investors on future financial performance.

Q & A Highlights

Q: Does the Q1 Vafseo revenue include any stocking or inventory build? What are you seeing in terms of dose frequency for in-center dialysis patients? How is protocolization gaining uptake at large-scale dialysis organizations? A: John Butler, CEO, explained that the Q1 revenue does include some inventory build as they maintain a two- to four-week range of inventory. Most dosing is currently daily (QD), with some smaller centers starting with three times weekly (TIW) dosing. Protocolization involves getting contracts and operational details in place, which takes time, especially for larger organizations. The first half of the year is expected to be driven by small and medium providers, with larger providers expected to move in the second half.

Q: Can you expand on the recent backlog in Auryxia? Has demand exceeded initial expectations? A: John Butler clarified that the backlog was for all phosphate binders and Vafseo, not just Auryxia. The transition to specialty pharmacy for prescriptions caused capacity issues, leading to a backlog. Akebia worked with customers to find capacity, and the backlog has since subsided. The demand is there, and operational issues are being addressed, which bodes well for product growth.

Q: What is the timing of the next regulatory interaction for initiating the VALOR study? Are you seeking alignment on study design? A: John Butler stated that the focus is on study design, and the FDA has shown a positive outlook on the need for an oral therapy for non-dialysis patients. The meeting will likely be a Type C meeting to discuss study design and analysis plans. The goal is to start the study as quickly as possible while ensuring alignment with the FDA.

Q: What launch metrics do you plan to disclose on a quarterly basis? A: Nicholas Grund, Chief Commercial Officer, mentioned that over 500 physicians have prescribed Vafseo with an average of eight prescriptions each. The focus is on driving breadth and depth of prescribing, with acceleration seen throughout the quarter. These metrics will help track progress.

Q: What is the current gross to net, and where do you expect it to settle? What is the split between commercial and Medicare? A: Nicholas Grund explained that Medicare and Medicare Advantage patients make up about 80% of the total, with immediate reimbursement for Medicare fee-for-service. About 15% of prescriptions are for Medicare Advantage patients, indicating successful contracting. Commercial patients are a smaller portion. John Butler added that gross to net will fluctuate with volume-based discounts and that the average dose is expected to increase over time.

Q: Are the costs for the VALOR study embedded within your current run rate? A: John Butler confirmed that the costs for the VALOR study are included in the current operating plan. The study is expected to be run efficiently, focusing on nephrologists and using a standard of care comparator.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

This article first appeared on GuruFocus.

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