Assertio Holdings

Overview

Assertio Holdings owns Assertio Specialty Pharmaceuticals, LLC and Spectrum Pharmaceuticals, Inc., along with their subsidiaries. Assertio Therapeutics was divested on May 9, 2025. The company focuses on oncology products and related supportive care. Its lead product is ROLVEDON (eflapegrastim-xnst), a long-acting G-CSF for reducing febrile neutropenia in adults receiving myelosuppressive cancer therapy. Other marketed products include Sympazan, SPRIX, INDOCIN, and CAMBIA. Otrexup commercialization ceased in July 2025.

In 2025 the company completed integration of the Spectrum merger under Assertio Specialty and continued product integration and go-to-market activities.

Key products and positioning

• ROLVEDON (eflapegrastim-xnst): long-acting G-CSF to reduce the risk of febrile neutropenia in adults receiving myelosuppressive chemotherapy. Targeted to hospital and community oncology clinics. Same-day dosing trial results were discussed in 2024–2025 and a full manuscript was published in 2026.
• Sympazan (clobazam): benzodiazepine for adjunctive treatment of seizures in Lennox-Gastaut Syndrome (LGS) in patients aged 2 years and older; film formulation using PharmFilm technology.
• INDOCIN (indomethacin): NSAID available as suppositories and oral suspension for indications that include rheumatoid arthritis, osteoarthritis, bursitis, tendinitis, and acute pain.
• SPRIX (ketorolac tromethamine): NSAID nasal spray for short-term pain relief.
• CAMBIA (diclofenac potassium for oral solution): NSAID approved for migraine symptoms; licensed for Canada to Searchlight Pharmaceuticals with royalty arrangements and patent expiry considerations.
• Otrexup: previously part of the portfolio; commercialization ceased in July 2025.

Financial snapshot (fiscal year 2025)

• Net product sales: $117.1 million (2024: $120.8 million).
• Product-level sales (2025):
  • ROLVEDON: $68.2 million
  • INDOCIN: $18.9 million
  • Sympazan: $11.3 million
  • Other net product sales (SPRIX, CAMBIA, etc.): $18.7 million
• Net loss from operations: $(21.5) million
• Comprehensive loss: $(30.4) million
• Cash, cash equivalents and short-term investments: $63.4 million as of December 31, 2025
• Operating cash flow used: $(28.2) million in 2025 (vs. $(26.4) million in 2024)

Corporate actions affecting 2025 results:

• Therapeutics Transaction (May 9, 2025): Assertio Therapeutics transferred to ATIH Industries, LLC. At the time of transfer, Assertio Therapeutics held approximately $8.2 million in cash/insurance and a single-digit royalty on net income from INDOCIN. Assertio retained certain legal liabilities, including opioid-related litigation, and was not a defendant in opioid-related litigation following the transaction.
• Reverse stock split: 1-for-15 on December 26, 2025, affecting outstanding shares and convertible notes; par value remained unchanged.

Customers and distribution

• Three national wholesale distributors accounted for the majority of net product sales.
• 2025 consolidated revenue by customer:
  • Cencora: 45%
  • McKesson Corporation: 31%
  • Cardinal Health: 10%
  • All others: 14%
• 2025 accounts receivable by customer:
  • Cencora: 44%
  • McKesson: 39%
  • Cardinal Health: 10%
  • All others: 7%

Manufacturing and supply

• The company does not operate in-house manufacturing and relies on contract manufacturers for clinical and commercial supply.
• Approved products are manufactured at facilities in the U.S., Canada, Italy, and South Korea. Each product depends on single-source suppliers for its active pharmaceutical ingredient (API).
• Quality issues in 2024–2025 led to inventory write-downs and may affect cost of sales in 2026.
• Major supply relationships and pricing commitments include Hanmi for the ROLVEDON API and suppliers for INDOCIN, Sympazan, SPRIX, and CAMBIA.

Intellectual property

• ROLVEDON patents: U.S. patents expire in 2039 (subject to extensions); U.S. patent applications potentially expiring in 2042; U.S. reference product exclusivity until 2034.
• Other patent positions:
  • Sympazan patents through 2040
  • Otrexup patents through 2030
  • CAMBIA patents through 2026
  • SPRIX process-related patents through 2029
• The company also relies on trade secrets and maintains collaboration and licensing arrangements, such as the CAMBIA Canada license with Searchlight.

Regulation and risk framework

• All products are subject to FDA regulation and ongoing post-approval requirements. The Section 505(b)(2) NDA pathway was used for some products, including CAMBIA.
• Pricing, reimbursement, and regulatory changes (for example, Medicare Part B ASP and broader healthcare reforms) materially influence sales and profitability.
• Manufacturing, quality control, FDA inspections, and potential competition from generics and biosimilars are key competitive factors.
• The company faces potential exposure to litigation and regulatory actions related to product sales, pricing, anti-kickback/false claims statutes, and open payments reporting.

Personnel

• 53 full-time U.S.-based employees as of March 9, 2026.
• No collective bargaining agreements. The company emphasizes competitive compensation, development opportunities, and an inclusive culture.

Corporate footprint and presence

• Website: http://www.assertiotx.com
• The 2025 transactions and the December 2025 reverse split reflect ongoing corporate restructuring and consolidation of product governance under Assertio Specialty.

Summary

Assertio is a U.S.-focused specialty pharmaceutical company anchored by ROLVEDON, with a portfolio that includes oncology-supportive and analgesic products. In 2025 the company reported $117.1 million in net product sales and operated at a net loss. Revenue concentration is concentrated among three major distributors. The business relies on contract manufacturing, faces competition from generics and biosimilars, and operates in a regulated environment with ongoing pricing and reimbursement pressures. The company completed the divestiture of Assertio Therapeutics in 2025 and executed a 1-for-15 reverse stock split in December 2025.