XIAFLEX Drug Profile

Summary for Tradename: XIAFLEX

High Confidence Patents:	3
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for XIAFLEX

Recent Clinical Trials for XIAFLEX

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Mayo Clinic	N/A
EndoPharmceuticals	Phase 3
Endo Pharmceuticals	Phase 3

See all XIAFLEX clinical trials

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 XIAFLEX Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Auxilium Pharmaceuticals, Inc.	XIAFLEX	collagenase clostridium histolyticum	For Injection	125338	6,022,539	2039-03-29	Company disclosures
Auxilium Pharmaceuticals, Inc.	XIAFLEX	collagenase clostridium histolyticum	For Injection	125338	7,811,560	2026-01-30	Company disclosures
Auxilium Pharmaceuticals, Inc.	XIAFLEX	collagenase clostridium histolyticum	For Injection	125338	RE39941	2039-02-26	Company disclosures

3) Low Certainty: US Patents for XIAFLEX 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
Auxilium Pharmaceuticals, Inc.	XIAFLEX	collagenase clostridium histolyticum	For Injection	125338	10,369,110	2033-03-15	Patent claims search
Auxilium Pharmaceuticals, Inc.	XIAFLEX	collagenase clostridium histolyticum	For Injection	125338	11,083,781	2040-10-08	Patent claims search
Auxilium Pharmaceuticals, Inc.	XIAFLEX	collagenase clostridium histolyticum	For Injection	125338	7,510,873	2023-06-27	Patent claims search
Auxilium Pharmaceuticals, Inc.	XIAFLEX	collagenase clostridium histolyticum	For Injection	125338	8,163,764	2022-04-26	Patent claims search

International Patents for XIAFLEX

Country	Patent Number	Estimated Expiration
Australia	2007211313
Brazil	PI0708017
Denmark	40398
European Patent Office	2474320

Market Dynamics and Financial Trajectory for the Biologic Drug: XIAFLEX

Introduction

XIAFLEX®, a biologic drug developed by BioSpecifics Technologies Corp. and marketed by Endo Pharmaceuticals, has been a significant player in the treatment of various medical conditions, including Peyronie's Disease and Dupuytren's Contracture. This article delves into the market dynamics and financial trajectory of XIAFLEX®, highlighting its performance, growth drivers, and challenges.

Historical Context and Development

XIAFLEX® is a collagenase-based therapy that has been on the market since its approval for the treatment of Dupuytren's Contracture in 2010 and later for Peyronie's Disease in 2013. The drug is also known as Xiapex® in Europe. BioSpecifics Technologies Corp. originated and continues to develop this therapy, with Endo Pharmaceuticals handling the commercial aspects[2].

Market Performance

Revenue Growth

XIAFLEX® has consistently shown strong revenue growth. In the third quarter of 2024, the XIAFLEX® franchise grew 13% to $128 million, driven by increased net selling prices and underlying demand growth[1]. Similarly, in the second quarter of 2024, XIAFLEX® revenues increased by 8% to $127 million compared to the same period in 2023, attributed to higher net selling prices and demand growth[3].

Segment Contributions

The Branded Pharmaceuticals segment, which includes XIAFLEX®, has been a key contributor to Endo's revenue. In the second quarter of 2024, Branded Pharmaceuticals segment revenues increased by 6% to $225 million, with XIAFLEX® being a significant component of this growth[3].

Commercial and Pipeline Highlights

Current Indications

XIAFLEX® is primarily used for the treatment of Dupuytren's Contracture and Peyronie's Disease. The drug's success in these indications has been a major driver of its revenue growth. Endo's continued emphasis on patient awareness and commercial execution has been instrumental in this success[2].

Future Development Plans

BioSpecifics and Endo are exploring additional indications for XIAFLEX®, including uterine fibroids and cellulite. Positive Phase 1 data for uterine fibroids has paved the way for further clinical development, and a BLA filing for the treatment of cellulite was anticipated in the second half of 2019[2].

Financial Performance

Revenue and Adjusted EBITDA

In the third quarter of 2024, while total revenues for Endo decreased by 6% to $427 million, the XIAFLEX® franchise contributed significantly to the company's adjusted EBITDA, which increased by 6% to $151 million. This increase was driven by reduced operating costs and improved margins[1].

Net Income and Adjusted Net Income

Despite the revenue growth from XIAFLEX®, Endo reported a net loss of $233 million in the third quarter of 2024, compared to a net loss of $28 million in the same period in 2023. Adjusted Net Income decreased by 53% to $62 million, primarily due to decreased revenues in other segments[1].

Challenges and Market Dynamics

Competitive Landscape

The pharmaceutical market is highly competitive, and XIAFLEX® faces challenges from generic competition and market dynamics. For instance, the Sterile Injectables and Generic Pharmaceuticals segments of Endo experienced significant declines in revenue due to generic competition and lower market volumes[1][5].

Pricing Dynamics

Drug pricing dynamics play a crucial role in the cost-effectiveness and financial performance of biologic drugs like XIAFLEX®. Studies have shown that price increases during the exclusivity period and subsequent price decreases after the loss of exclusivity can significantly impact the cost-effectiveness of these drugs[4].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the pharmaceutical industry. For XIAFLEX®, the pandemic led to challenging market conditions, particularly for specialty product office-based elective procedures. However, the situation improved in later quarters as healthcare systems adapted[5].

Strategic Initiatives

Repricing of Debt

Endo successfully completed the repricing of a $1.5 billion term loan, reducing the interest rate by 50 basis points. This move is expected to improve the company's financial flexibility and reduce interest expenses[1].

Cost Reduction and Margin Improvement

Endo's focus on reducing operating costs and improving margins has been a key factor in the increased adjusted EBITDA. These efforts are crucial for maintaining profitability in a competitive market[1].

Future Outlook

Financial Guidance

Endo has reaffirmed its 2024 financial guidance, expecting total revenues between $1,720 million and $1,780 million and adjusted EBITDA between $635 million and $655 million. The continued growth of the XIAFLEX® franchise is expected to be a significant contributor to these projections[1].

Market Expansion

The potential addition of new indications, such as uterine fibroids and cellulite, could further expand the market for XIAFLEX®. Successful clinical trials and regulatory approvals will be critical for these expansions[2].

Key Takeaways

• Revenue Growth: XIAFLEX® has shown consistent revenue growth, driven by increased net selling prices and demand.
• Segment Contributions: The Branded Pharmaceuticals segment, including XIAFLEX®, is a key revenue driver for Endo.
• Future Indications: Additional indications such as uterine fibroids and cellulite are being explored.
• Financial Performance: Adjusted EBITDA has increased despite overall revenue declines, thanks to cost reductions and margin improvements.
• Challenges: The drug faces challenges from generic competition and market dynamics.
• Strategic Initiatives: Endo has implemented cost reduction and debt repricing strategies to improve financial flexibility.

FAQs

What is XIAFLEX® used for?

XIAFLEX® is used for the treatment of Dupuytren's Contracture and Peyronie's Disease, with potential future indications including uterine fibroids and cellulite.

How has XIAFLEX® performed financially in recent quarters?

In the third quarter of 2024, XIAFLEX® revenues grew 13% to $128 million, and in the second quarter of 2024, revenues increased by 8% to $127 million.

What are the main challenges facing XIAFLEX® in the market?

XIAFLEX® faces challenges from generic competition, market dynamics, and the impact of COVID-19 on elective procedures.

What strategic initiatives has Endo taken to improve financial performance?

Endo has reduced operating costs, improved margins, and repriced a $1.5 billion term loan to reduce interest expenses.

What is the future outlook for XIAFLEX®?

Endo expects continued growth from XIAFLEX®, with potential new indications and reaffirmed financial guidance for 2024.

Sources

1. Endo Reports Third-Quarter 2024 Financial Results and Reaffirms 2024 Financial Expectations. Stock Titan.
2. BioSpecifics Technologies Corp. Reports Second Quarter 2019 Financial and Operating Results. PR Newswire.
3. ENDO REPORTS SECOND-QUARTER 2024 FINANCIAL RESULTS. Endo Investor Relations.
4. The Influence of US Drug Price Dynamics on Cost-Effectiveness Analyses. PubMed.
5. ENDO REPORTS FOURTH-QUARTER 2022 FINANCIAL RESULTS. PR Newswire.