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Avadel
🇮🇪 NASDAQ:AVDL
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Sep 30, 2022

Avadel Q3 2022 Earnings Report

Announced third quarter financial results and provided a corporate update.

Key Takeaways

Avadel Pharmaceuticals reported its Q3 2022 financial results with a net loss of $20.1 million. The company is preparing for the commercial launch of LUMRYZ, expected no later than Q3 2023, and is working to potentially accelerate its final approval. Cash, cash equivalents and marketable securities were $106.5 million as of September 30, 2022.

LUMRYZ granted tentative approval on July 18, confirming its safety profile and clinical efficacy

Final approval decision of LUMRYZ expected by June 2023; advancing strategy to potentially accelerate final approval

Commercial launch planned for no later than Q3 2023; launch preparations underway

Updated RESTORE data demonstrates 94% of switch patients prefer once-at-bedtime LUMRYZ dosing regimen

EPS
-$0.33
Previous year: -$0.38
-13.2%
R&D Expenses
$2.9M
Previous year: $4.4M
-34.1%
SG&A Expenses
$14.1M
Previous year: $21.3M
-33.8%
Cash and Equivalents
$107M
Previous year: $181M
-41.2%
Free Cash Flow
-$7.52M
Previous year: -$21.2M
-64.6%
Total Assets
$146M
Previous year: $264M
-44.8%

Avadel

Avadel

Forward Guidance

The company focuses on the timing of FDA’s final approval decision for LUMRYZ, efforts to accelerate the FDA’s final approval decision, preparations to accelerate the timing between a potential final approval of LUMRYZ and commercial launch as well as the expected results thereof, the estimated once-at-bedtime oxybate market and anticipated market acceptance of LUMRYZ, the continued advancement of the RESTORE study to generate long-term safety, tolerability, and efficacy data for LUMRYZ, the company’s cash runway and anticipated uses of capital, and the expected maturity of the company’s convertible debt.

Positive Outlook

  • Expectations regarding the timing of FDA’s final approval decision for LUMRYZ
  • Ongoing efforts of the Company to accelerate the FDA’s final approval decision
  • The Company’s preparations to accelerate the timing between a potential final approval of LUMRYZ and commercial launch as well as the expected results thereof
  • The estimated once-at-bedtime oxybate market and anticipated market acceptance of LUMRYZ (if approved)
  • The continued advancement of the RESTORE study to generate long-term safety, tolerability, and efficacy data for LUMRYZ

Challenges Ahead

  • Company’s cash runway
  • Anticipated uses of capital
  • Expected maturity of the Company’s convertible debt.
  • Risks and uncertainties described in the “Risk Factors” section of Part I, Item 1A of the Company’s Annual Report on Form 10-K for the year ended December 31, 2021
  • Subsequent SEC filings

Company Overview

Full financial data and analysis

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