Market Dynamics and Financial Trajectory for Purified Cortrophin® Gel
Introduction to Cortrophin Gel
Purified Cortrophin® Gel, an adrenocorticotropic hormone (ACTH) therapy, is a key asset in ANI Pharmaceuticals' Rare Disease portfolio. It is indicated for the treatment of certain chronic autoimmune disorders. Here, we will delve into the market dynamics and financial trajectory of this drug since its launch.
Launch and Initial Market Reception
The U.S. commercial launch of Cortrophin Gel occurred on January 24, 2022. The initial reception was positive, with over 250 new patient cases initiated in the first quarter, and a steady growth in new cases per week[1][4][5].
Launch Trajectory
The launch trajectory of Cortrophin Gel has been robust. By the end of the first quarter of 2022, the company reported significant improvements in the time from new case initiation to patient dispense, leading to a steady increase in patients on the therapy. As of August 2022, the number of new patient cases had doubled to approximately 500, with over 250 unique prescribers involved[1][5].
Physician Interest and Market Access
Physician interest in Cortrophin Gel has been substantial. Over 125 unique prescribers initiated new cases in the first quarter, with about 25% of these prescribers enrolling more than one patient. By the second quarter, this number had doubled, with approximately one-third of prescribers writing multiple prescriptions. The therapy has seen widespread adoption across targeted specialties such as rheumatology, neurology, and nephrology[1][4][5].
Market access efforts have been successful, with formulary coverage for Cortrophin Gel extending to over 100 million lives by the first quarter of 2022, and further expanding to over 134 million lives by the second quarter[1][4].
Financial Performance
Revenue Guidance and Actuals
For 2022, ANI Pharmaceuticals initially provided revenue guidance for Cortrophin Gel in the range of $35 million to $40 million. This guidance was later raised to $40 million to $45 million due to the strong launch trajectory[1][5].
In the fourth quarter of 2023, Cortrophin Gel revenues reached $41.7 million, a 137.3% increase year-over-year, contributing significantly to the company's overall revenue growth[2].
For 2024, the company has provided revenue guidance for Cortrophin Gel in the range of $170 million to $180 million, reflecting a continued strong growth trajectory[2].
Quarterly and Annual Revenue
- First Quarter 2022: Net sales of Cortrophin Gel were not explicitly stated but were part of the overall net revenues of $64.5 million[1].
- Second Quarter 2022: Cortrophin Gel net sales were $10.2 million, contributing to the company's record net revenues of $73.9 million[5].
- Third Quarter 2022: Net revenues were $83.8 million, with significant contributions from Cortrophin Gel, though specific figures were not detailed[3].
- Fourth Quarter 2023: Cortrophin Gel revenues were $41.7 million, a significant increase from the previous year[2].
Adjusted Non-GAAP EBITDA and EPS
The financial performance of ANI Pharmaceuticals, including Cortrophin Gel, has also been reflected in adjusted non-GAAP EBITDA and EPS. For 2022, the company guided for adjusted non-GAAP EBITDA between $54 million and $60 million and adjusted non-GAAP diluted EPS between $1.34 and $1.62[1][5].
In 2023, the adjusted non-GAAP EBITDA was $133.8 million, and for 2024, the guidance is between $135 million and $145 million[2].
Operational and Strategic Highlights
Research and Development
The acquisition of Novitium has strengthened ANI Pharmaceuticals' R&D capabilities. The company launched several new products, including Misoprostol Tablets, Rifabutin Capsules, and Bisoprolol Tablets, and filed six new ANDA applications in the first quarter of 2022[1].
Market Expansion and Infrastructure
ANI Pharmaceuticals has continued to invest in the launch initiatives of Cortrophin Gel, expanding its hub, patient support services, and distribution network. These efforts have contributed to the improved conversion rates from enrollment to fulfillment and enhanced market access[3][5].
Leadership and Governance
The company has also made significant appointments, including Renee P. Tannenbaum, Pharm.D., MBA, to the Board of Directors, and Meredith W. Cook as SVP, General Counsel and Corporate Secretary, further solidifying its leadership and governance structure[1][5].
Challenges and Expenses
Cost of Sales and Operating Expenses
The cost of sales, excluding depreciation and amortization, increased significantly due to higher volumes and costs associated with the acquisition of Novitium. Operating expenses also rose, driven by increased selling, general, and administrative expenses, as well as research and development expenses related to Novitium activities[1][3].
Net Loss and Debt
Despite the revenue growth, ANI Pharmaceuticals reported net losses in several quarters, partly due to the high operating expenses and debt. The face value of debt was $297.8 million as of September 30, 2022[3].
Future Outlook
2024 Guidance
For 2024, ANI Pharmaceuticals expects total company net revenue to be between $520 million and $542 million, with Cortrophin Gel revenue guidance of $170 million to $180 million. Adjusted non-GAAP EBITDA is expected to be between $135 million and $145 million[2].
Continued Market Penetration
The company is poised to continue its strong market penetration for Cortrophin Gel, driven by expanding market access, increased physician awareness, and ongoing investments in launch initiatives.
Key Takeaways
- Strong Launch Trajectory: Cortrophin Gel has seen significant growth in patient cases and prescriber engagement since its launch.
- Market Access: Formulary coverage for over 100 million lives has been achieved, with continued expansion.
- Financial Performance: Revenue guidance has been consistently raised, reflecting the drug's strong market reception.
- Operational Strengths: Investments in R&D, market expansion, and infrastructure have supported the drug's success.
- Challenges: Higher operating expenses and debt remain key challenges.
FAQs
What is Cortrophin Gel used for?
Cortrophin Gel is an adrenocorticotropic hormone (ACTH) therapy used for the treatment of certain chronic autoimmune disorders.
When was Cortrophin Gel launched?
Cortrophin Gel was launched on January 24, 2022.
How has the market reception been for Cortrophin Gel?
The market reception has been positive, with over 250 new patient cases initiated in the first quarter and significant growth in subsequent quarters.
What is the revenue guidance for Cortrophin Gel in 2024?
The revenue guidance for Cortrophin Gel in 2024 is between $170 million and $180 million.
What are the key factors driving the success of Cortrophin Gel?
Key factors include strong physician interest, expanded market access, and continued investments in launch initiatives and infrastructure.
Cited Sources:
- ANI Pharmaceuticals Reports First Quarter 2022 Results; Provides Purified Cortrophin® Gel Net Revenue Guidance and Full-Year 2022 Total Company Net Revenue Guidance of $295 Million to $315 Million. ANI Pharmaceuticals.
- ANI Pharmaceuticals Reports Fourth Quarter and Record Full-Year 2023 Financial Results and Provides 2024 Guidance. GlobeNewswire.
- ANI Pharmaceuticals Reports Third Quarter 2022 Financial Results. Business Wire.
- Provides Purified Cortrophin® Gel Net Revenue Guidance and Full-Year 2022 Total Company Net Revenue Guidance. ANI Pharmaceuticals.
- ANI Pharmaceuticals Reports Second Quarter 2022 Financial Results; Reports Record Net Revenues and Raises Full-Year 2022 Net Revenue Guidance for Purified Cortrophin® Gel. ANI Pharmaceuticals.
