Daxibotulinumtoxina-lanm - Biologic Drug Details

Summary for daxibotulinumtoxina-lanm

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

Pharmacology for daxibotulinumtoxina-lanm

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

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 daxibotulinumtoxina-lanm Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for daxibotulinumtoxina-lanm Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for daxibotulinumtoxina-lanm Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for DaxibotulinumtoxinA-lanm (DAXXIFY)

Introduction to DAXXIFY

DaxibotulinumtoxinA-lanm, marketed as DAXXIFY, is a revolutionary biologic drug developed by Revance Therapeutics. It is the first and only FDA-approved long-lasting, peptide-formulated neuromodulator product, marking a significant innovation in the field of neuromodulators.

FDA Approval and Therapeutic Indications

DAXXIFY received its first therapeutic indication from the FDA for the treatment of cervical dystonia in adults, in addition to its previous approval for the temporary improvement of glabellar lines (frown lines) in adults[4].

Market Entry and Expansion

Revance Therapeutics has successfully launched DAXXIFY into the U.S. therapeutics neurotoxin market, a sector valued at $2.7 billion. This entry positions DAXXIFY as a compelling new treatment option for patients and physicians, particularly for those suffering from cervical dystonia, a painful and disabling chronic condition[1][2][4].

Financial Performance

Quarterly and Annual Revenue

In the second quarter of 2024, Revance Therapeutics reported strong financial results, with total product revenue increasing by 20% year-over-year (YoY) to $65.3 million. DAXXIFY net revenue specifically grew by 27% YoY to $28.7 million, with aesthetic units sold increasing by 65% YoY. The RHA Collection, another product line, generated $36.6 million, up 15% YoY[2].

For the third quarter of 2024, total net revenue was $59.9 million, an 11% increase from the same period in 2023, driven by increased sales volumes of DAXXIFY and the RHA Collection. Total net revenue for the nine months ended September 30, 2024, was $177.2 million, up from $154.3 million in the same period in 2023[5].

Revenue Guidance and Projections

Revance maintains its 2024 total net product revenue guidance of at least $280 million. The company is also projecting to reach cash flow break-even and achieve positive Adjusted EBITDA in 2025[2][5].

Pricing Strategy and Market Access

To accelerate market share expansion, Revance introduced a new pricing program for DAXXIFY effective September 1, 2023, positioning the product competitively with Botox® Cosmetic for providers. This strategy aims to enhance the product's adoption and market penetration[3].

Clinical Performance and Safety Profile

Clinical trials, such as the ASPEN OLS study, have demonstrated DAXXIFY's differentiated performance profile. Symptoms of cervical dystonia continued to improve with successive treatments, while adverse events, including dysphagia (difficulty swallowing), remained low. This reinforces DAXXIFY’s safety and efficacy profile[4].

Supply Chain and Manufacturing

Revance expects its long-term supply chain strategy to support a U.S. DAXXIFY adjusted gross margin of over 80%. The FDA's approval of the manufacturing site of their partner, Ajinomoto Bio-Pharma Services, in late Q1 2023, has allowed for the capitalization of subsequent DAXXIFY manufacturing expenses as inventory, optimizing costs[3][5].

Operational Efficiencies and Strategic Focus

Revance has exited the OPUL® payments business to prioritize capital allocation and streamline operations, freeing up approximately $20 million annually for reinvestment in DAXXIFY aesthetics and therapeutic commercial launches. This strategic move aligns with their vision to maximize portfolio value through focused commercial strategies[3].

Financial Outlook and Cash Position

As of June 30, 2024, Revance had $232.2 million in cash, cash equivalents, and short-term investments. By September 30, 2024, this figure had decreased to $184.1 million. Despite the decrease, the company remains funded to achieve breakeven and expects to be Adjusted EBITDA positive in 2025[2][5].

Market Feedback and Adoption

Real-world feedback from providers and patients has reinforced DAXXIFY’s differentiated performance profile, indicating continued opportunity for long-term, broad-based adoption. Early feedback from payers and market access dynamics also suggest positive market reception[3].

Competitive Landscape

DAXXIFY’s entry into the $2.7 billion U.S. therapeutic neurotoxin market positions it as a significant competitor to established products like Botox®. The unique formulation and long-lasting efficacy of DAXXIFY are expected to capture a substantial market share, leveraging its innovative Peptide Exchange Technology™[1][4].

Key Takeaways

• FDA Approval: DAXXIFY is approved for the treatment of cervical dystonia and glabellar lines.
• Market Entry: Successful launch into the $2.7 billion U.S. therapeutic neurotoxin market.
• Financial Performance: Strong Q2 and Q3 2024 results with increasing revenue and improved financials.
• Pricing Strategy: Competitive pricing to enhance market share.
• Clinical Performance: Demonstrated safety and efficacy in clinical trials.
• Supply Chain: Optimized manufacturing costs with FDA-approved partner site.
• Operational Efficiencies: Streamlined operations by exiting non-core businesses.
• Financial Outlook: Projected to reach cash flow break-even and positive Adjusted EBITDA in 2025.

FAQs

What is DAXXIFY used for?

DAXXIFY is used for the treatment of cervical dystonia and the temporary improvement of glabellar lines (frown lines) in adults.

How has DAXXIFY performed financially?

DAXXIFY has shown strong financial performance with a 27% YoY increase in net revenue to $28.7 million in Q2 2024 and continued growth in Q3 2024.

What is the competitive landscape for DAXXIFY?

DAXXIFY competes in the $2.7 billion U.S. therapeutic neurotoxin market, positioning itself against established products like Botox® with its innovative Peptide Exchange Technology™.

What are the key clinical findings for DAXXIFY?

Clinical trials have shown that DAXXIFY improves symptoms of cervical dystonia with successive treatments while maintaining a low rate of adverse events, including dysphagia.

When does Revance expect to be Adjusted EBITDA positive?

Revance projects reaching cash flow break-even and achieving positive Adjusted EBITDA in 2025.

How has Revance optimized its operations?

Revance has exited the OPUL® payments business to focus capital allocation and streamline operations, freeing up resources for DAXXIFY commercial launches.

Sources

1. Revance Therapeutics, Inc. - DAXXIFY® (DaxibotulinumtoxinA-lanm) for injection is the first and only FDA approved long-lasting, peptide formulated neuromodulator product [Investors Revance Therapeutics][1]
2. Stocktitan - Revance Reports Second Quarter 2024 Financial Results, Provides Corporate Update [Stocktitan][2]
3. Revance Therapeutics, Inc. - Commercial launch plans, future growth opportunities, and financial review and outlook [Cloudfront.net][3]
4. Revance Therapeutics, Inc. - U.S. FDA Approves First Therapeutic Indication for Revance's DAXXIFY® (DaxibotulinumtoxinA-lanm) for Injection for the Treatment of Cervical Dystonia [Investors Revance Therapeutics][4]
5. Business Wire - Revance Reports Third Quarter 2024 Financial Results, Provides Corporate Update [Business Wire][5]

Last updated: 2024-12-22