AMTAGVI Drug Profile

Summary for Tradename: AMTAGVI

High Confidence Patents:	0
Applicants:	1
BLAs:	1

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for AMTAGVI Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for AMTAGVI Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for AMTAGVI Derived from Patent Text Search

No patents found based on company disclosures

AMTAGVI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of AMTAGVI

Introduction to AMTAGVI

AMTAGVI, also known as Lifileucel, is a groundbreaking T cell therapy developed by Iovance Biotherapeutics for the treatment of advanced melanoma. The FDA approved AMTAGVI in mid-February 2024, marking a significant milestone in the field of cancer treatment.

Market Approval and Launch

• FDA Approval: AMTAGVI received FDA approval for the treatment of advanced melanoma, paving the way for its U.S. commercial launch in February 2024[1][4].
• Initial Patient Treatments: The first commercial infusion of AMTAGVI took place in April 2024, with over 146 patients treated as of the third quarter of 2024[3][4].

Revenue Recognition and Growth

• Revenue Generation: Revenue from AMTAGVI is recognized at the time of patient infusion, contributing significantly to Iovance’s product revenue. In the second quarter of 2024, AMTAGVI generated $12.8 million in revenue, while total product revenue for the quarter was $31.1 million[2][4].
• Quarterly Growth: Iovance expects significant quarter-over-quarter growth in product revenue, driven by the increasing adoption of AMTAGVI. The third quarter of 2024 saw a substantial increase in infusions, with total product revenue reaching $58.6 million, including $42.1 million from AMTAGVI[3][5].

Financial Projections and Guidance

• 2024 Projections: Iovance anticipates total product revenue for 2024 to be between $160 million and $165 million, reflecting three quarters of AMTAGVI sales following FDA approval[2][3].
• 2025 Projections: For 2025, the company expects total product revenue to range from $450 million to $475 million, with gross margins expected to surpass 70% over the next several years. This growth is driven by both existing and new Authorized Treatment Centers (ATCs) adopting AMTAGVI[2][3].

Cash Position and Funding

• Cash Position: As of September 30, 2024, Iovance had a cash position of $403.8 million, which is expected to fund operations into early 2026[3][5].
• Cash Burn: The company projects a cash burn of $320 million to $340 million for 2024, which is managed by the strong cash position and anticipated revenue growth[1][5].

Global Expansion and Regulatory Submissions

• Global Expansion: Iovance is expanding its global commercial footprint with regulatory submissions underway in various countries, including the EU and UK. Potential approvals are expected by late 2025, further increasing market access for AMTAGVI[3][4].
• Manufacturing Capacity: The company is scaling up manufacturing capacity to meet growing demand, aiming to serve over 10,000 patients annually in the future[5].

Operational Highlights

• Authorized Treatment Centers (ATCs): Iovance aims to increase the number of ATCs from 56 to around 70 by the end of 2024, enhancing patient access to AMTAGVI[5].
• Net Loss Improvement: Despite a net loss of $83.5 million in Q3 2024, this was an improvement from Q3 2023’s loss of $113.8 million, indicating operational efficiency gains[5].

Key Takeaways

1. FDA Approval: AMTAGVI received FDA approval for advanced melanoma treatment.
2. Revenue Growth: Significant quarter-over-quarter growth in product revenue driven by AMTAGVI’s adoption.
3. Financial Projections: Total product revenue expected to reach $160-165 million in 2024 and $450-475 million in 2025.
4. Cash Position: Strong cash position of $403.8 million as of September 30, 2024, expected to fund operations into early 2026.
5. Global Expansion: Regulatory submissions underway for broader market access in the EU and UK.

FAQs

1. When was AMTAGVI approved by the FDA?

   • AMTAGVI was approved by the FDA in mid-February 2024[1][4].

2. How much revenue did AMTAGVI generate in the second quarter of 2024?

   • AMTAGVI generated $12.8 million in revenue during the second quarter of 2024[2][4].

3. What is the projected total product revenue for 2025?

   • The projected total product revenue for 2025 is expected to be between $450 million and $475 million[2][3].

4. How many patients have been treated with AMTAGVI as of the third quarter of 2024?

   • Over 146 patients have been treated with AMTAGVI as of the third quarter of 2024[3][5].

5. What is the expected cash burn for 2024?

   • The expected cash burn for 2024 is projected to be between $320 million and $340 million[1][5].

Sources

1. Iovance Biotherapeutics Reports on AMTAGVI Launch and Financials
2. Iovance Biotherapeutics Reports Financial Results and Corporate Updates for Second Quarter and First Half 2024
3. Iovance Q3 Revenue Surges to $58.6M as Amtagvi Launch Gains Momentum
4. Iovance Biotherapeutics Reports Financial Results and Corporate Updates for Second Quarter and First Half 2024
5. Earnings Call: Iovance Reported a Third-Quarter Product Revenue of $586 Million