ASCENIV Drug Profile

Summary for Tradename: ASCENIV

High Confidence Patents:	0
Applicants:	1
BLAs:	1

Pharmacology for ASCENIV

Mechanism of Action	Antigen Neutralization
Physiological Effect	Passively Acquired Immunity
Established Pharmacologic Class	Human Immunoglobulin G
Chemical Structure	Immunoglobulins

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 ASCENIV Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Adma Biologics, Inc.	ASCENIV	immune globulin intravenous, human-slra	Injection	125590	10,001,489	2032-12-20	Patent claims search
Adma Biologics, Inc.	ASCENIV	immune globulin intravenous, human-slra	Injection	125590	10,011,660	2032-04-30	Patent claims search
Adma Biologics, Inc.	ASCENIV	immune globulin intravenous, human-slra	Injection	125590	10,144,776	2033-02-26	Patent claims search
Adma Biologics, Inc.	ASCENIV	immune globulin intravenous, human-slra	Injection	125590	10,227,383	2035-05-20	Patent claims search
Adma Biologics, Inc.	ASCENIV	immune globulin intravenous, human-slra	Injection	125590	10,280,208	2034-04-30	Patent claims search
Adma Biologics, Inc.	ASCENIV	immune globulin intravenous, human-slra	Injection	125590	10,732,111	2033-03-15	Patent claims search
Adma Biologics, Inc.	ASCENIV	immune globulin intravenous, human-slra	Injection	125590	10,739,262	2033-03-15	Patent claims search

Market Dynamics and Financial Trajectory for the Biologic Drug: ASCENIV

Introduction

ASCENIV, a flagship immunoglobulin product developed by ADMA Biologics, has been a game-changer in the biologics market, particularly in treating refractory immunodeficient patients. This article delves into the market dynamics and financial trajectory of ASCENIV, highlighting its impact on ADMA Biologics and the broader pharmaceutical industry.

Revenue Growth and Market Penetration

ASCENIV has been the primary driver of ADMA Biologics' remarkable revenue growth. In the second quarter of 2024, the company reported a 78% year-over-year increase in revenue, reaching $107.2 million, with ASCENIV contributing over 50% of the total revenue[1][3][5].

This trend continued into the third quarter, where revenue surged to $119.8 million, a 78% year-over-year increase, with ASCENIV still accounting for more than 50% of the company's revenue[2][5].

Financial Performance

The financial performance of ADMA Biologics has been significantly bolstered by ASCENIV. The company's GAAP net income increased by 1,300% to $35.9 million in the third quarter of 2024, while adjusted EBITDA grew by 256% to $45.4 million[2][5].

Key Financial Metrics

• Revenue: $119.8 million in Q3 2024, up 78% year-over-year[2][5].
• GAAP Net Income: $35.9 million in Q3 2024, a 1,300% increase[2][5].
• Adjusted EBITDA: $45.4 million in Q3 2024, a 256% increase[2][5].
• Gross Margin: Improved to 50% from 37% in Q3 2023[2].

Market Potential and Growth Projections

ASCENIV is projected to become a billion-dollar revenue opportunity, driven by its unique formulation and expanding market penetration. The product's potential in treating refractory immunodeficient patients and its growing prescriber base are key factors contributing to this projection[1][4][5].

Future Financial Guidance

ADMA Biologics has revised its financial guidance upwards for 2024 and 2025, anticipating revenues to exceed $415 million and $465 million, respectively. Adjusted EBITDA is forecasted to be over $160 million and $215 million for the same periods[5].

Strategic Initiatives and Innovation

To meet the growing demand for ASCENIV, ADMA Biologics is implementing several strategic initiatives:

Plasma Supply Enhancement

The company is focusing on improving plasma supply through donor retention programs and partnerships with third-party plasma collectors. These efforts aim to increase high-titer plasma collections, which are crucial for ASCENIV production[4][5].

Manufacturing Efficiency

Recent advances in manufacturing processes have shown potential yield enhancements of approximately 20% more product from the same plasma. These initiatives, pending regulatory approval, are expected to benefit the company financially by late 2025[3][4].

AI and Machine Learning

ADMA Biologics is leveraging its AI and machine learning platform, ADMAlytics, to optimize production efficiency and commercial planning. This is projected to improve net earnings by reducing costs and increasing output[4].

Regulatory Approvals and Label Expansion

The company is anticipating regulatory approvals that could further boost ASCENIV's market expansion. A potential pediatric label expansion, expected by the first half of 2026, could significantly expand the product's market and utilization[4][5].

Balance Sheet and Financial Health

ADMA Biologics' strong balance sheet and financial health are underpinned by its robust operating cash flow and significant working capital. As of Q3 2024, the company had $86.7 million in cash and $273.3 million in working capital[2].

Risks and Challenges

Despite the promising outlook, there are risks and challenges associated with ASCENIV's success. These include reliance on consistent plasma supply, uncertainties in regulatory approvals, and competition in the biologics market[1][4].

"ASCENIV now represents over 50% of ADMA's total revenue, with significant market potential in treating refractory immunodeficient patients. The product's unique formulation and potential market penetration could drive peak annual sales over $1 billion, though technological advancements and existing competition pose risks."[1]

Conclusion

ASCENIV has transformed ADMA Biologics' financial trajectory, driving significant revenue growth and margin expansion. With a strong market position, strategic initiatives to enhance production and supply, and a favorable regulatory environment, ASCENIV is poised to continue its upward trend.

Key Takeaways

• Revenue Growth: ASCENIV has driven a 78% year-over-year increase in ADMA Biologics' revenue.
• Financial Performance: GAAP net income and adjusted EBITDA have seen substantial increases.
• Market Potential: ASCENIV is projected to become a billion-dollar revenue opportunity.
• Strategic Initiatives: Focus on plasma supply enhancement, manufacturing efficiency, and AI-driven optimization.
• Regulatory Approvals: Potential pediatric label expansion by 2026.
• Financial Health: Strong balance sheet with significant cash and working capital.

FAQs

Q: What is the primary driver of ADMA Biologics' revenue growth?

A: The primary driver of ADMA Biologics' revenue growth is its flagship product, ASCENIV.

Q: How much revenue did ADMA Biologics generate in Q3 2024?

A: ADMA Biologics generated $119.8 million in revenue in Q3 2024.

Q: What is the projected peak annual sales potential for ASCENIV?

A: The projected peak annual sales potential for ASCENIV is over $1 billion.

Q: What initiatives is ADMA Biologics taking to enhance plasma supply?

A: ADMA Biologics is implementing plasma donor retention programs and partnering with third-party plasma collectors to increase high-titer plasma collections.

Q: When is the potential pediatric label expansion for ASCENIV expected?

A: The potential pediatric label expansion for ASCENIV is expected by the first half of 2026.

Sources

1. Seeking Alpha: "ADMA Biologics: Riding High On ASCENIV's Success"
2. Stock Titan: "ADMA Biologics Announces Third Quarter 2024 Financial Results"
3. Alpha Spread: "ADMA Q2-2024 Earnings Call"
4. Simply Wall St: "AI And Regulatory Approvals Will Boost ASCENIV's Market Expansion"
5. Investing.com: "Earnings call: ADMA Biologics reports robust growth, raises guidance"

Last updated: 2024-12-18