Akebia Therapeutics ((AKBA)) has held its Q4 earnings call. Read on for the main highlights of the call.
Akebia Therapeutics’ recent earnings call paints a picture of cautious optimism, driven by the strong initial launch of Vafseo. The company reported higher-than-expected revenue and broad market access for Vafseo, alongside positive momentum in Medicare Advantage uptake. Despite these successes, challenges such as decreased Auryxia revenue, specialty pharmacy fulfillment issues, and an increased net loss were also highlighted. Overall, the sentiment remains positive due to the promising launch of Vafseo and regulatory progress.
Strong Launch of Vafseo
Akebia Therapeutics has exceeded expectations with the launch of Vafseo, anticipating net product revenue between $10 million and $11 million in the first quarter of 2025. This performance surpasses analyst estimates and is supported by over 500 physicians prescribing the drug, averaging eight prescriptions each. The robust launch underscores the product’s potential in the market.
Extensive Market Access Achieved
The company has secured commercial supply contracts with dialysis providers, ensuring nearly 100% coverage of U.S. dialysis patients. This extensive market access is complemented by significant early engagement from physicians and dialysis organizations, setting a strong foundation for Vafseo’s growth.
Positive Uptake in Medicare Advantage
Vafseo has seen a successful uptake within Medicare Advantage plans, with 15% of prescriptions covered under these plans. This indicates effective contracting by dialysis organizations and highlights the drug’s growing acceptance in the healthcare market.
Financial Stability and Cash Position
Akebia reported a solid financial position with $51.9 million in cash and cash equivalents at the end of 2024, supplemented by an additional $18.4 million raised post year-end. This financial stability is expected to support operations for at least two years, providing a strong foundation for future growth.
Encouraging Regulatory Engagement for VALOR Study
The FDA has shown a willingness to discuss the protocol for the VALOR Phase 3 trial, which could pave the way for potential approval for non-dialysis patients. This regulatory engagement is a positive sign for Akebia’s future prospects in expanding Vafseo’s use.
Decreased Revenue from Auryxia
Auryxia’s net product revenues have decreased from $53.2 million in Q4 2023 to $44.4 million in Q4 2024, primarily due to reduced volume. This decline highlights a challenge that Akebia needs to address to maintain its overall revenue growth.
Backlog in Specialty Pharmacy Fulfillment
A significant backlog in fulfilling prescriptions through specialty pharmacies has impacted patient access to Vafseo in early 2025. This issue presents a logistical challenge that the company must overcome to ensure consistent patient access to its products.
Net Loss Increases
Akebia reported a net loss of $22.8 million in Q4 2024, a significant increase from a net income of $0.6 million in Q4 2023. The annual net loss also rose to $69.4 million in 2024 from $51.9 million in 2023, highlighting the financial challenges the company faces despite its revenue successes.
Forward-Looking Guidance
Looking ahead, Akebia is optimistic about the continued success of Vafseo, with expected net product revenue between $10 million and $11 million for the first quarter of 2025. The company plans to initiate the VALOR study for non-dialysis patients in the second half of 2025, following discussions with the FDA. Akebia is focused on making Vafseo the standard-of-care and remains confident in its financial outlook.
In summary, Akebia Therapeutics’ earnings call reflects a cautiously optimistic outlook, driven by the successful launch of Vafseo and positive regulatory engagement. While challenges such as decreased Auryxia revenue and increased net loss persist, the company’s strong market access and financial stability provide a solid foundation for future growth.