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Last Updated: December 26, 2024

ROLVEDON Drug Profile


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Summary for Tradename: ROLVEDON
High Confidence Patents:0
Applicants:1
BLAs:1
Pharmacology for ROLVEDON
Physiological EffectIncreased Myeloid Cell Production
Established Pharmacologic ClassLeukocyte Growth Factor
Chemical StructureGranulocyte Colony-Stimulating Factor
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
  2. 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.

  3. General brand-side disclosures
  4. 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.

  5. Patents from broad patent text search
  6. 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 ROLVEDON Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

ROLVEDON Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: ROLVEDON

Introduction

ROLVEDON, a biologic drug acquired by Assertio Holdings, Inc. in July 2023, has been a significant addition to the company's portfolio. This article delves into the market dynamics and financial trajectory of ROLVEDON, highlighting its growth prospects, challenges, and the overall impact on Assertio's financial performance.

Acquisition and Initial Impact

Assertio's acquisition of ROLVEDON on July 31, 2023, marked a new phase for the company. Since the acquisition, ROLVEDON has shown promising growth, addressing initial challenges such as channel inventory issues and optimizing the commercial team to drive sales[1].

Sales Performance

ROLVEDON's sales have been on an upward trend. In the fourth quarter of 2023, ROLVEDON generated $11 million in net sales, a 38% increase over the pro forma third quarter. This sequential growth continued into 2024, with sales increasing to $14.5 million in the first quarter and further to $15.1 million in the second quarter[1][2][4].

Market Share and Growth Prospects

As of the fourth quarter of 2023, ROLVEDON had acquired an estimated 30% share in the current served markets. Assertio sees significant opportunities to expand this market share through its contracting and commercial access team capabilities. The drug has experienced sequential quarter-over-quarter demand growth since its launch, and this trend is expected to continue into 2024[1].

Commercial Strategy

Assertio is investing in both personal and non-personal promotion strategies to drive ROLVEDON awareness and sales. The company plans to focus on customer expansion through in-person promotions and leverage digital non-personal promotion models to further enhance market reach[1].

Financial Guidance for 2024

For 2024, Assertio expects ROLVEDON to generate net sales approaching $60 million. This projection is part of the company's overall financial guidance, which includes net product sales in the range of $110 million to $125 million and adjusted EBITDA of $20 million to $30 million[1][2].

Gross Margin and Operating Expenses

The gross margin for ROLVEDON has been impacted by inventory step-up amortization, but excluding this, the gross margin has been robust. In the second quarter of 2024, the gross margin was 73% when excluding the inventory step-up amortization. Operating expenses, including SG&A, have been managed efficiently, with a slight decrease from the first quarter to the second quarter of 2024[2][4].

Cash Flow and Balance Sheet

Assertio has maintained a positive cash flow from operations, with $7.4 million generated in the second quarter of 2024. The company's cash and short-term investments have increased to $88.4 million, providing a strong financial foundation for continued investment in ROLVEDON and other assets[2].

Challenges: Generic Competition

While ROLVEDON has shown strong growth, Assertio faces challenges from generic competition, particularly with its product Indocin. Indocin sales have declined due to generic competition, affecting both volume and pricing. However, the company is managing this impact through careful pricing and volume management strategies[1][2][4].

Integration and Portfolio Diversification

The acquisition of ROLVEDON is part of Assertio's broader strategy to diversify its revenue base and enhance its commercial capabilities. The integration of ROLVEDON is expected to benefit other assets in the portfolio, such as Sympazan, Otrexup, and Sprix, by leveraging the proven market access and contracting capabilities of the ROLVEDON team[5].

Industry Context: Biologics Market

The biologics market, in which ROLVEDON operates, is expected to grow significantly. The global biologics market size is projected to reach USD 699.5 billion by 2032, driven by factors such as the rising prevalence of chronic diseases, technological advancements, and increasing adoption of biosimilars[3].

Key Takeaways

  • Strong Sales Growth: ROLVEDON has shown consistent sequential growth since its acquisition.
  • Market Share Expansion: The drug has acquired a significant market share and is expected to continue expanding.
  • Financial Performance: Assertio's financial guidance for 2024 is positive, with ROLVEDON contributing significantly to the company's revenue.
  • Challenges: Generic competition remains a challenge, particularly for other products like Indocin.
  • Integration Benefits: The acquisition is part of a broader strategy to diversify revenue and enhance commercial capabilities.

FAQs

What was the impact of the acquisition of ROLVEDON on Assertio's financial performance?

The acquisition of ROLVEDON has been positive, with the drug showing sequential sales growth and contributing significantly to Assertio's revenue. It has helped in addressing channel inventory issues and optimizing the commercial team[1].

How has ROLVEDON's sales performance been since its acquisition?

ROLVEDON's sales have increased sequentially, from $11 million in the fourth quarter of 2023 to $15.1 million in the second quarter of 2024. This growth is expected to continue into 2024[1][2][4].

What are the key drivers of ROLVEDON's market success?

The key drivers include effective commercial strategies, expansion of market share, and continued investment in both personal and non-personal promotion models[1].

How does generic competition affect Assertio's products?

Generic competition, particularly for Indocin, has led to declines in sales volume and pricing. However, Assertio is managing this impact through careful pricing and volume management strategies[1][2][4].

What is the projected market size for biologics by 2032?

The global biologics market size is expected to reach USD 699.5 billion by 2032, driven by various factors including the rising prevalence of chronic diseases and technological advancements[3].

Sources

  1. Alpha Spread: ASRT Q4-2023 Earnings Call.
  2. Stock Titan: Assertio Reports Second Quarter 2024 Financial Results.
  3. Biospace: Biologics Market Size to Reach USD 699.5 Billion by 2032.
  4. Investing.com: Earnings call: Assertio Holdings reports Q2 2024 with Rolvedon growth.
  5. Biospace: Assertio Reports Second Quarter 2023 Financial Results, Closes Spectrum Acquisition.

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