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Avadel Pharmaceuticals plc(AVDL) - 2024 Q3 - Quarterly Results

Avadel Pharmaceuticals Corporate Update and Third Quarter 2024 Financial Results Avadel Pharmaceuticals reports strong Q3 2024 financial and operational results, driven by LUMRYZ™ and key milestones Third Quarter 2024 Highlights Avadel Pharmaceuticals reported strong Q3 2024 with $50.0 million LUMRYZ™ revenue, 2,300 patients, and key regulatory and legal milestones | Metric | Value | | :--- | :--- | | Net Revenue (LUMRYZ™) | $50.0 million | | Total Patients on LUMRYZ | 2,300 (as of Sept 30) | | New Patients in Q3 | 700 | - Received FDA approval for LUMRYZ to treat cataplexy or EDS in narcolepsy patients aged 7 and older, with Orphan Drug Exclusivity (ODE) granted through October 16, 203116 - A U.S. District Court upheld the FDA's determination that LUMRYZ is clinically superior to twice-nightly oxybate products, mitigating a significant legal and business risk from a suit brought by Jazz Pharmaceuticals125 - The company is advancing its Phase 3 REVITALYZ™ study to evaluate LUMRYZ for treating idiopathic hypersomnia (IH)16 Business and Operational Updates Avadel achieved significant LUMRYZ™ commercial milestones, including $50.0 million Q3 net revenue and patient growth, with key legal and FDA approvals LUMRYZ Commercial Updates LUMRYZ achieved $50.0 million in Q3 net product revenue and expanded its patient base, especially among new oxybate users | Metric | Q3 2024 | | :--- | :--- | | Net Product Revenue | $50.0 million | | Total Patients on Therapy | 2,300 | | New Patients Initiating Therapy | 700 | - The fastest-growing patient segment for LUMRYZ consists of individuals who are new to oxybate therapy, indicating market expansion4 Corporate and Pipeline Updates Key corporate updates include a favorable court ruling, FDA pediatric approval for LUMRYZ, and ongoing Phase 3 REVITALYZ study enrollment - On October 30, 2024, a U.S. District Court ruled in favor of the FDA, upholding LUMRYZ's approval and its clinical superiority over Jazz Pharmaceuticals' twice-nightly oxybate products5 - On October 16, 2024, the FDA approved LUMRYZ for patients 7 years or older with narcolepsy and granted Orphan Drug Exclusivity (ODE) through October 16, 20316 - Patient enrollment is ongoing for the pivotal Phase 3 REVITALYZ study, evaluating LUMRYZ's efficacy and safety in idiopathic hypersomnia (IH)6 - Recent publications highlighted LUMRYZ's efficacy with alerting agents, high patient preference (94%) for the once-nightly regimen, and an association with weight loss78 Third Quarter 2024 Financial Performance Avadel reported a dramatic increase in Q3 2024 net product revenue to $50.0 million, significantly narrowing its operating and net losses year-over-year | Financial Metric | Q3 2024 | Q3 2023 | Change (YoY) | | :--- | :--- | :--- | :--- | | Net Product Revenue | $50.0M | $7.0M | +614% | | Gross Profit | $43.9M | $6.9M | +536% | | Total Operating Expenses | $44.2M | $42.0M | +5.2% | | Operating Loss | ($0.3M) | ($35.1M) | +99.1% | | Net Loss | ($2.6M) | ($36.3M) | +92.8% | | Net Loss per Share | ($0.03) | ($0.41) | +92.7% | - Operating expenses included $6.4 million in non-cash charges, comprising $5.4 million in stock-based compensation and $1.0 million in depreciation and amortization10 - Cash, cash equivalents, and marketable securities stood at $65.8 million as of September 30, 202413 - Cash usage in the quarter included a $2.0 million commitment fee payment related to a decision not to draw on a second financing tranche13 Financial Statements The financial statements detail Avadel's Q3 2024 performance, showing significant revenue growth, reduced net loss, and improved cash flow from operations Condensed Consolidated Statements of Loss The statements detail Avadel's Q3 2024 financial performance, showing significant revenue growth and reduced net loss year-over-year Three Months Ended September 30 (in thousands) | Account | 2024 | 2023 | | :--- | :--- | :--- | | Net product revenue | $50,025 | $7,014 | | Gross profit | $43,870 | $6,897 | | Total operating expense | $44,197 | $42,007 | | Operating loss | ($327) | ($35,110) | | Net loss | ($2,625) | ($36,274) | | Net loss per share - diluted | ($0.03) | ($0.41) | Nine Months Ended September 30 (in thousands) | Account | 2024 | 2023 | | :--- | :--- | :--- | | Net product revenue | $118,707 | $8,510 | | Gross profit | $108,242 | $8,357 | | Total operating expense | $147,344 | $121,306 | | Operating loss | ($39,102) | ($112,949) | | Net loss | ($43,789) | ($131,490) | | Net loss per share - diluted | ($0.46) | ($1.71) | Condensed Consolidated Balance Sheets The balance sheets present Avadel's financial position, detailing assets, liabilities, and shareholders' equity as of September 30, 2024 Assets (in thousands) | Account | Sept 30, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $28,582 | $31,167 | | Marketable securities | $37,225 | $73,944 | | Total current assets | $127,258 | $134,202 | | Total assets | $158,253 | $164,698 | Liabilities and Shareholders' Equity (in thousands) | Account | Sept 30, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Total current liabilities | $42,783 | $36,855 | | Total liabilities | $83,590 | $76,959 | | Total shareholders' equity | $74,663 | $87,739 | | Total liabilities and shareholders' equity | $158,253 | $164,698 | Condensed Consolidated Statements of Cash Flows The cash flow statement highlights improved net cash usage in operating activities for the nine months ended September 30, 2024 Nine Months Ended September 30 (in thousands) | Cash Flow Activity | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | ($54,780) | ($100,482) | | Net cash provided by (used in) investing activities | $36,867 | ($78,021) | | Net cash provided by financing activities | $15,090 | $156,446 | | Net change in cash and cash equivalents | ($2,585) | ($22,170) | | Cash and cash equivalents at end of period | $28,582 | $51,811 | Product and Company Information Avadel Pharmaceuticals focuses on innovative medication development, with LUMRYZ™ as its FDA-approved, once-at-bedtime sodium oxybate treatment for narcolepsy - LUMRYZ™ is the first and only once-at-bedtime treatment for cataplexy or EDS in adults and children (7 years and older) with narcolepsy15 - The FDA granted LUMRYZ 7 years of Orphan Drug Exclusivity, finding it clinically superior to twice-nightly oxybate treatments because its once-nightly dosing avoids nocturnal arousal17 - Avadel Pharmaceuticals focuses on applying innovative solutions to develop medications that address challenges with current treatment options18 Important Safety Information and Forward-Looking Statements The report includes important safety information for LUMRYZ™ regarding CNS depressant risks and abuse potential, alongside standard forward-looking statement disclosures - LUMRYZ has a BOXED Warning regarding risks of co-administration with other CNS depressants (like alcohol or sedatives), which can cause respiratory depression, hypotension, and death19 - Due to its active ingredient (a form of GHB), LUMRYZ is a controlled substance available only through a restricted Risk Evaluation and Mitigation Strategy (REMS) program to prevent abuse19 - Common side effects in adults include nausea, dizziness, and headache, while in children they include nausea, bedwetting, and vomiting26 - The press release contains forward-looking statements concerning the commercialization of LUMRYZ, market demand, and clinical studies, which are subject to significant risks and uncertainties2829