Prabotulinumtoxina-xvfs - Biologic Drug Details

Summary for prabotulinumtoxina-xvfs

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1

Pharmacology for prabotulinumtoxina-xvfs

Mechanism of Action	Acetylcholine Release Inhibitors
Physiological Effect	Neuromuscular Blockade
Established Pharmacologic Class	Acetylcholine Release Inhibitor Neuromuscular Blocker

Note on Biologic Patents

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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 prabotulinumtoxina-xvfs Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for prabotulinumtoxina-xvfs Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for prabotulinumtoxina-xvfs Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for PrabotulinumtoxinA-xvfs (Jeuveau)

Introduction

PrabotulinumtoxinA-xvfs, marketed under the brand name Jeuveau, is a botulinum toxin type A formulation approved by the FDA in February 2019 for the temporary improvement of moderate-to-severe glabellar lines. This article delves into the market dynamics and financial trajectory of Jeuveau, highlighting its efficacy, market performance, and future outlook.

Efficacy and Clinical Trials

Jeuveau has demonstrated significant efficacy in clinical trials. Phase II and III trials showed that patients treated with prabotulinumtoxinA-xvfs experienced greater improvement in the Glabellar Line Scale (GLS) at maximum frown on day 30, with 87.2% of patients achieving a greater than 2-point improvement, compared to 82.8% for onabotulinumtoxinA and 4.2% for the placebo group[1].

Market Acceptance and Demand

Since its launch in May 2019, Jeuveau has seen strong market acceptance. The product has been well-received by both clinicians and patients, contributing to its rapid growth. In 2021, Evolus reported a record quarter with $34.7 million in net revenue, representing a 68% year-over-year growth and a 30% quarter-over-quarter growth[4].

Financial Performance

Evolus, the company behind Jeuveau, has reported impressive financial metrics. For the nine months ended September 30, 2024, Evolus generated $187.3 million in net revenues, a 32.8% increase from $141.1 million in the same period of 2023. The gross profit margin for 2024 stood at 69.2%, indicating a healthy profitability margin[5].

Revenue Growth

The revenue growth of Jeuveau has been robust, driven by increasing demand and successful market penetration. In 2022, Evolus reported total net revenues of $99.7 million, with Q4 revenues of $34.7 million, marking a significant increase from previous years[4].

Operating Expenses and Loss

Despite the revenue growth, Evolus has incurred operating expenses and losses. For the nine months ended September 30, 2024, the company reported a net loss of $43.6 million and a loss from operations of $32.1 million. However, these figures are improving, with non-GAAP operating expenses and losses decreasing over time[5].

Cash and Funding

Evolus has managed its cash flow effectively, with $85.0 million in cash and cash equivalents as of September 30, 2024. The company projects that its existing cash balance will fund current operations, eliminating the need for additional capital[5].

Market Dynamics and Competition

The aesthetic neurotoxin market is highly competitive, with established players like Botox. However, Jeuveau has carved out a significant niche for itself. Evolus expects total net revenues for 2023 to be between $180 million and $190 million, representing a 21% to 28% year-over-year growth, which is more than double the estimated growth rate of the aesthetic neurotoxin market[2].

International Expansion

Evolus is expanding its reach internationally. The company commenced its EU launch in Q3 2022 and received acceptance for Nuceiva® (the European brand name for Jeuveau) from the Australian regulatory authority. This expansion is expected to further boost revenue and market presence[4].

Future Outlook

Evolus projects a positive outlook for Jeuveau. The company expects to achieve non-GAAP operating income in the fourth quarter of 2023 and anticipates total net revenue to reach $500 million by 2028, representing a 22% compound annual growth rate[2].

Therapeutic Indications

Beyond aesthetic uses, botulinum toxins like Jeuveau have over 230 therapeutic uses documented in scientific literature and nine approved therapeutic indications in the U.S. AEON Biopharma, which has development and distribution rights for therapeutic indications of ABP-450 (the same botulinum toxin complex as Jeuveau), plans to address the estimated $3.0 billion global therapeutic botulinum toxin market[3].

Key Takeaways

• Efficacy: Jeuveau has shown significant efficacy in clinical trials, outperforming competitors in some metrics.
• Market Acceptance: Strong market acceptance and demand have driven rapid revenue growth.
• Financial Performance: Evolus has reported increasing revenues and improving financial metrics, despite operating losses.
• Market Dynamics: Jeuveau competes in a growing aesthetic neurotoxin market, with a strong international expansion strategy.
• Future Outlook: Positive projections include achieving non-GAAP operating income and significant revenue growth by 2028.

FAQs

What is PrabotulinumtoxinA-xvfs (Jeuveau)?

PrabotulinumtoxinA-xvfs, marketed as Jeuveau, is a botulinum toxin type A formulation approved for the temporary improvement of moderate-to-severe glabellar lines.

How effective is Jeuveau in clinical trials?

Jeuveau has demonstrated high efficacy in clinical trials, with 87.2% of patients achieving a greater than 2-point improvement in the Glabellar Line Scale (GLS) at maximum frown on day 30[1].

What are the financial metrics of Evolus for 2024?

For the nine months ended September 30, 2024, Evolus reported $187.3 million in net revenues, a 32.8% increase from the previous year, with a gross profit margin of 69.2% and a net loss of $43.6 million[5].

Is Jeuveau available internationally?

Yes, Jeuveau is expanding internationally, with launches in the EU and acceptance from the Australian regulatory authority for Nuceiva®, the European brand name for Jeuveau[4].

What are the future projections for Jeuveau?

Evolus projects total net revenue to reach $500 million by 2028, representing a 22% compound annual growth rate, and expects to achieve non-GAAP operating income in the fourth quarter of 2023[2].

Are there therapeutic indications for Jeuveau beyond aesthetics?

Yes, botulinum toxins like Jeuveau have numerous therapeutic uses, and AEON Biopharma is developing ABP-450 for therapeutic indications in various markets[3].

Sources

1. PubMed: "PrabotulinumtoxinA-xvfs for the Treatment of Moderate-to-Severe Glabellar Lines: A Systematic Review of Phase II and III Clinical Trials."
2. Evolus: "Evolus Reports Fourth Quarter and Full Year 2022 Results and Provides Business Update 2023."
3. AEON Biopharma: "AEON Biopharma, Inc. - cloudfront.net"
4. Evolus Investor Presentation: "MARCH 2022 - Evolus-March-2022-Investor-Presentation-FINAL.pdf"
5. Evolus Financial Metrics: "Evolus, Inc. (EOLS): history, ownership, mission, how it works - dcf.fm"

Last updated: 2024-12-18