ANIP Q3 2024: Robust Cortrophin Volume Boosts Rare Disease Business
- Cortrophin Gel’s robust volume growth: The Q&A indicates that nearly all growth is coming from volume increases across multiple therapeutic areas (neurology, nephrology, rheumatology, ophthalmology, gout, pulmonology) driven by both new prescribers and share gains from competitors.
- Synergistic benefits from the Alimera acquisition: The integration of Alimera has led to a cross-trained, 45-person ophthalmology sales force promoting ILUVIEN, YUTIQ, and Cortrophin Gel. This integration is expected to drive additional revenue and incremental EBITDA in 2025, underscoring a transformative opportunity for ANI’s rare disease business.
- Innovative product enhancements: The introduction of a prefilled syringe for Cortrophin Gel is designed to improve patient convenience and administration, which could further boost product adoption and strengthen market position.
- Integration and transitional risks: The commercial organization is still undergoing realignment and integration of the 45-person ophthalmology sales team post-Alimera acquisition, which may delay or hamper achieving the expected sales acceleration for ILUVIEN, YUTIQ, and Cortrophin Gel.
- Supply chain concerns for YUTIQ: There are emerging supply challenges with YUTIQ, as noted by management's collaboration with EyePoint to address FDA concerns. Any delay in resolving these issues could adversely affect product availability and revenues.
- Dependence on volume-driven growth for Cortrophin Gel: The growth in Cortrophin is primarily volume-based, relying heavily on increased patient starts and prescriber adoption. A slowdown in volume growth or market saturation could pressure the product's revenue trajectory.
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ILUVIEN Guidance
Q: Q4 run rate and NEW DAY impact?
A: Management indicated that the ILUVIEN and YUTIQ guidance of $30–32 million in Q4 reflects integration adjustments and that the commercial team is well‐positioned to accelerate these products into 2025, with the NEW DAY study potentially supporting improvements but not being the sole driver of growth. -
Cortrophin Growth
Q: What drives Cortrophin growth?
A: They emphasized that nearly all of the strong Cortrophin performance is driven by volume increases, with increased prescriptions across all target specialties, making rare disease the company’s largest growth driver. -
Ophthalmology Impact
Q: How is the sales team impacting Cortrophin?
A: Early indications suggest that the combined ophthalmology sales team, now integrated post-acquisition, is showing promise in boosting Cortrophin in ophthalmology, and the upcoming prefilled syringe should further enhance patient convenience. -
Payer and Generics Outlook
Q: How are payers and generics affecting growth?
A: Management noted that while they maintain strong market access for Cortrophin amid evolving payer dynamics, they also expect a steady cadence of new generics launches to drive growth in the high single-digit to low double-digit range. -
Acquisition Learnings
Q: What lessons from the Alimera acquisition?
A: They stressed that sticking to strategic priorities and addressing operational bumps—such as supply chain issues with YUTIQ—are key takeaways, underscoring their focus on seamless integration in future deals.
Research analysts covering ANI PHARMACEUTICALS.