In This Article:
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Total Revenue: $37.4 million in Q3 2024, down from $42 million in Q3 2023.
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AURYXIA Net Product Revenue: $35.6 million in Q3 2024, compared to $40.1 million in Q3 2023.
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License, Collaboration, and Other Revenue: $1.8 million in Q3 2024, compared to $1.9 million in Q3 2023.
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Cost of Goods Sold: $14.2 million in Q3 2024, down from $18 million in Q3 2023.
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Research and Development Expense: $8.5 million in Q3 2024, down from $13.3 million in Q3 2023.
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SG&A Expense: $26.5 million in Q3 2024, up from $22.7 million in Q3 2023.
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Net Loss: $20 million in Q3 2024, compared to $14.5 million in Q3 2023.
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Cash and Cash Equivalents: $34 million at the end of Q3 2024, with pro forma cash of $43.7 million after ATM facility proceeds.
Release Date: November 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
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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.
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The company has secured TDAPA reimbursement from CMS and received HCPCS codes, facilitating reimbursement processes for dialysis organizations.
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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.
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The company is conducting the VOICE trial to generate important clinical data, aiming to support Vafseo utilization and potentially expand its market.
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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
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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.
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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.
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There is uncertainty regarding the introduction of generic versions of AURYXIA, which could impact revenue levels.
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The company faces challenges in expanding Vafseo's label to non-dialysis patients, requiring further regulatory interactions and clinical work.
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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.