Introduction to AZSTARYS
AZSTARYS, developed by KemPharm and commercialized by Corium, Inc., is a novel once-daily treatment for attention deficit hyperactivity disorder (ADHD) in patients aged six years and older. It combines 70% extended-release serdexmethylphenidate (SDX), a prodrug of d-methylphenidate (d-MPH), with 30% immediate-release d-MPH, offering both rapid and sustained therapeutic effects[3][4].
Market Context: ADHD Treatment
The ADHD market is substantial and growing, with revenues of approximately $17.9 billion in 2019. The year-over-year prescription growth rate was greater than 4%, and the branded portion of the ADHD market accounted for around $7.4 billion. Extended-release products dominate over 97% of the branded prescriptions, and the methylphenidate segment, where AZSTARYS operates, saw about 20 million prescriptions and $4.9 billion in sales in 2019[3].
Unique Selling Proposition of AZSTARYS
AZSTARYS stands out due to its innovative formulation, which provides a dual-action effect. This combination of SDX and immediate-release d-MPH offers rapid onset and extended duration of therapeutic benefits, addressing the unmet needs in the market for early onset of action and long duration of therapy[3][4].
FDA Approval and Commercial Launch
AZSTARYS received FDA approval in March 2021 and was commercially launched in July 2021. The launch was supported by a double-blind, randomized, placebo-controlled phase 3 study that demonstrated symptom improvement without serious adverse effects[3][4].
Commercial Performance
Despite initial challenges, including COVID-19 related disruptions and limited formulary coverage, AZSTARYS has seen increasing prescription volumes. By the third quarter of 2022, Corium had achieved coverage with the three largest pharmacy benefit managers (PBMs) and doubled its field force to 175 representatives, leading to a meaningful increase in prescription volumes starting in July 2022[3].
Financial Trajectory
KemPharm's financial position has been positively impacted by the commercialization of AZSTARYS. Here are some key financial highlights:
- Royalties and Revenue: KemPharm earns royalties from the sales of AZSTARYS. In 2022, KemPharm reported net revenue of $10.5 million, with a solid balance sheet and cash, cash equivalents, and investments totaling $102.9 million as of December 31, 2022[3].
- Milestones and Growth: Year-to-date net sales of AZSTARYS surpassed $25 million in 2023, triggering the first net sales milestone payment of $5 million. This growth trajectory is crucial for KemPharm's long-term financial health and market presence[1][3].
Formulary Coverage and Market Access
Achieving formulary coverage with major PBMs has been a key factor in the drug's commercial success. This coverage has helped increase the accessibility of AZSTARYS to a broader patient population. As of the third quarter of 2022, Corium had secured coverage with the three largest PBMs, significantly enhancing market access[3].
Price Analysis
AZSTARYS is currently available as a brand name drug only, with no generic version available until at least December 9, 2037, based on patent and regulatory protections[3].
- Current Pricing: The cost for AZSTARYS oral capsules ranges from $1,478.71 for a supply of 100 capsules, depending on the pharmacy. This translates to a per-unit cost of approximately $14.79 per capsule[5].
- Discount Programs: Patients can benefit from copay savings programs and discount cards, such as the Drugs.com Discount Card, which can save up to 80% or more off the cost of prescription medicines[5].
Future Outlook and Strategic Positioning
KemPharm and Corium are optimistic about the future of AZSTARYS. The drug's unique formulation and growing market acceptance position it well within the ADHD treatment landscape. As the prescription trend continues to improve, it is expected to contribute significantly to KemPharm's revenue and market share.
Price Projections
Given the current market dynamics and the drug's performance, here are some key price projection considerations:
- Market Growth: The ADHD market is expected to continue growing, driven by increasing prescription volumes and the lack of generic competition until 2037. This growth is likely to support higher revenues for AZSTARYS[3].
- Formulary Coverage: Continued expansion of formulary coverage with major PBMs will enhance market access and potentially drive up demand, which could stabilize or increase prices[3].
- Competition: The absence of generic competition until 2037 provides a significant market advantage, allowing AZSTARYS to maintain its pricing without immediate pressure from generic alternatives[3].
Expert Insights
According to Greg Mattingly, M.D., of St. Charles Psychiatric Associates, "The availability of the first medicine to use the novel prodrug SDX expands the therapeutic options that families and their physicians can consider when deciding the most suitable ADHD symptom management treatment for children." This innovative therapy is particularly significant due to its rapid onset and sustained therapeutic effects[3].
Key Takeaways
- Innovative Formulation: AZSTARYS combines extended-release and immediate-release components, offering rapid and sustained therapeutic effects.
- Market Context: The ADHD market is large and growing, with the methylphenidate segment being a significant part.
- Commercial Performance: Despite initial challenges, AZSTARYS has seen increasing prescription volumes following improved formulary coverage.
- Financial Impact: The drug contributes to KemPharm's revenue through royalties and is expected to reach sales milestones.
- Patient Access: Corium offers copay savings programs to enhance patient access.
- Price Stability: The lack of generic competition until 2037 is likely to support stable or increasing prices.
FAQs
Q: What is the current pricing for AZSTARYS?
A: The cost for AZSTARYS oral capsules ranges from $1,478.71 for a supply of 100 capsules, depending on the pharmacy[5].
Q: When will generic versions of AZSTARYS be available?
A: The earliest date for generic entry will be December 9, 2037, based on patent and regulatory protections[3].
Q: How has the commercial launch of AZSTARYS performed?
A: Despite initial challenges, AZSTARYS has seen increasing prescription volumes following improved formulary coverage with major PBMs[3].
Q: What are the key financial highlights for KemPharm related to AZSTARYS?
A: KemPharm reported net revenue of $10.5 million in 2022 and earned a $5 million milestone payment in 2023 due to surpassing $25 million in year-to-date net sales[1][3].
Q: How does AZSTARYS differentiate itself in the ADHD market?
A: AZSTARYS stands out due to its innovative formulation, combining extended-release and immediate-release components to offer rapid onset and sustained therapeutic effects[3][4].
Sources
- Zevra Therapeutics Reports Corporate Updates and Second Quarter 2023 Financial Results
- Zacks Small-Cap Research
- Introduction to AZSTARYS
- U.S. Food and Drug Administration Approves Novel Once-Daily Treatment for ADHD
- Azstarys Prices, Coupons, Copay Cards & Patient Assistance
