Akebia Therapeutics Inc (AKBA) Q3 2024 Earnings Call Highlights: Navigating Revenue Challenges ...

GuruFocus.com
08 Nov 2024
  • Total Revenue: $37.4 million in Q3 2024, down from $42 million in Q3 2023.
  • AURYXIA Net Product Revenue: $35.6 million in Q3 2024, compared to $40.1 million in Q3 2023.
  • License, Collaboration, and Other Revenue: $1.8 million in Q3 2024, compared to $1.9 million in Q3 2023.
  • Cost of Goods Sold: $14.2 million in Q3 2024, down from $18 million in Q3 2023.
  • Research and Development Expense: $8.5 million in Q3 2024, down from $13.3 million in Q3 2023.
  • SG&A Expense: $26.5 million in Q3 2024, up from $22.7 million in Q3 2023.
  • Net Loss: $20 million in Q3 2024, compared to $14.5 million in Q3 2023.
  • Cash and Cash Equivalents: $34 million at the end of Q3 2024, with pro forma cash of $43.7 million after ATM facility proceeds.
  • Warning! GuruFocus has detected 6 Warning Signs with AKBA.

Release Date: November 07, 2024

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

Positive Points

  • Akebia Therapeutics Inc (NASDAQ:AKBA) is preparing for the U.S. market availability of Vafseo, expected in January 2025, with significant progress on launch initiatives.
  • The company has secured TDAPA reimbursement from CMS and received HCPCS codes, facilitating reimbursement processes for dialysis organizations.
  • Akebia has established commercial supply contracts covering approximately 60% of dialysis patients, with a goal to secure coverage for nearly 100% by the end of the year.
  • The company is conducting the VOICE trial to generate important clinical data, aiming to support Vafseo utilization and potentially expand its market.
  • Akebia has a strong financial position with $43.7 million in cash and cash equivalents, providing at least two years of cash runway post-Q3 2024.

Negative Points

  • Total revenue for Q3 2024 decreased to $37.4 million from $42 million in Q3 2023, primarily due to a reduction in AURYXIA net product revenue.
  • The company reported a net loss of $20 million in Q3 2024, compared to a net loss of $14.5 million in Q3 2023, partly due to non-cash interest expenses.
  • There is uncertainty regarding the introduction of generic versions of AURYXIA, which could impact revenue levels.
  • The company faces challenges in expanding Vafseo's label to non-dialysis patients, requiring further regulatory interactions and clinical work.
  • SG&A expenses increased to $26.5 million in Q3 2024 from $22.7 million in Q3 2023, driven by pre-launch activities for Vafseo.

Q & A Highlights

Q: Can you provide an update on the potential for label expansion into the non-dialysis market and the feedback from nephrologists at ASN Kidney Week? A: John Butler, CEO, explained that Akebia plans to engage with the FDA this year to discuss a clinical path for non-dialysis label expansion. The company expects to outline a study protocol that aligns with FDA requirements. Feedback from ASN Kidney Week was positive, with nephrologists expressing a strong interest in Vafseo as an alternative therapy for anemia management.

Q: What is the goal for dialysis center contracts by the launch date in January, and how will the Voice trial impact prescribing? A: John Butler, CEO, stated that the goal is to have 100% of dialysis centers under contract by launch. The Voice trial, which is expected to start enrolling patients soon, will provide important data on Vafseo's dosing and outcomes, potentially influencing prescribing practices and supporting broader adoption post-TDAPA.

Q: How is Akebia addressing the upcoming generic competition for AURYXIA, and what impact does it have on revenue? A: John Butler, CEO, noted that while generic competition is anticipated, Akebia has established contracts that allow for price adjustments to maintain revenue. The company aims to leverage AURYXIA's presence to support Vafseo's growth, viewing it as a tool to facilitate broader market penetration.

Q: What percentage of the home dialysis segment is currently contracted, and what are the plans for early-stage programs like acute kidney injury? A: Nicholas Grund, Chief Commercial Officer, indicated that both home and in-center dialysis populations are included in current contracts, with approximately 60% coverage. For early-stage programs, John Butler, CEO, mentioned that the acute kidney injury program is in pre-IND development, with plans to enter the clinic by the end of next year.

Q: What are the key takeaways from nephrologists regarding Vafseo's clinical use and market readiness? A: Nicholas Grund, Chief Commercial Officer, highlighted that nephrologists are eager to implement Vafseo, asking detailed clinical questions about dosing and transitioning from current therapies. There is a recognized need for alternative therapies, and Vafseo is seen as a potential new standard of care.

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

This article first appeared on GuruFocus.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Most Discussed

  1. 1
     
     
     
     
  2. 2
     
     
     
     
  3. 3
     
     
     
     
  4. 4
     
     
     
     
  5. 5
     
     
     
     
  6. 6
     
     
     
     
  7. 7
     
     
     
     
  8. 8
     
     
     
     
  9. 9
     
     
     
     
  10. 10