Avadel Pharmaceuticals plc(AVDL) - 2025 Q2 - Quarterly Results

Q2 2025 Highlights and Updated 2025 Guidance Avadel reported strong Q2 2025 results with LUMRYZ™ net revenue of $68.1 million, a 64% year-over-year increase, leading to the first quarterly net income ($9.7 million) and positive cash flow since the product's launch. The number of patients on LUMRYZ grew 63% year-over-year to 3,100. Consequently, the company raised its full-year 2025 revenue guidance to $265-$275 million and provided Q3 2025 revenue guidance of $71-$75 million | Metric | Q2 2025 | Change vs Q2 2024 | | :--- | :--- | :--- | | LUMRYZ™ Net Revenue | $68.1 million | +64% | | Patients on LUMRYZ | 3,100 | +63% | | Net Income | $9.7 million | N/A (Turned from loss) | | Earnings Per Share (EPS) | $0.10 | N/A (Turned from loss) | | Guidance | 2025 Full Year | Q3 2025 | | :--- | :--- | :--- | | Net Product Revenue | $265 - $275 million (Raised) | $71 - $75 million | | Cash Operating Expenses | Not specified for full year | $50 - $55 million | - The company achieved its first quarterly net income and positive cash flow since the launch of LUMRYZ in 2023, driven by strong uptake, growing patient numbers, and improved persistency[3][4] Second Quarter 2025 Financial Results In Q2 2025, Avadel's net product revenue from LUMRYZ sales grew 64% to $68.1 million compared to Q2 2024. The company achieved a significant financial turnaround, reporting a net income of $9.7 million, or $0.10 per diluted share, compared to a net loss of $13.8 million in the prior-year period. Total operating expenses remained relatively stable at $52.9 million | Financial Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Net Product Revenue | $68.1M | $41.5M | | Total Operating Expenses | $52.9M | $51.5M | | R&D Expenses | $4.3M | $4.1M | | SG&A Expenses | $48.6M | $47.4M | | Net Income (Loss) | $9.7M | ($13.8M) | | Diluted EPS | $0.10 | ($0.14) | - The company generated positive cash flow, increasing its cash, cash equivalents, and marketable securities by $15.0 million during the quarter to a total of $81.5 million as of June 30, 2025[4][11] - Q2 2025 marked the first quarter the company has generated net income since LUMRYZ was launched[10] Corporate and Pipeline Updates Avadel strengthened its leadership by appointing Susan Rodriguez as COO. The company received a favorable court ruling affirming LUMRYZ's FDA approval and clinical superiority. In pipeline developments, LUMRYZ was granted FDA Orphan Drug Designation for Idiopathic Hypersomnia (IH), with the pivotal Phase 3 REVITALYZ trial for this indication on track to complete enrollment by the end of 2025 - Appointed Susan Rodriguez, an experienced biopharma executive, as Chief Operating Officer to oversee commercial strategy and operations[13] - The U.S. Court of Appeals affirmed the FDA's approval of LUMRYZ and its finding that the once-at-bedtime dosing is clinically superior to other oxybates[13] - LUMRYZ was granted FDA Orphan Drug Designation for the treatment of Idiopathic Hypersomnia (IH)[3][13] - The Phase 3 REVITALYZ study for LUMRYZ in IH is on track to complete enrollment by the end of 2025, with topline data expected in 2026[3][13] About LUMRYZ™ LUMRYZ™ (sodium oxybate) is the first and only FDA-approved once-at-bedtime treatment for cataplexy or excessive daytime sleepiness (EDS) in narcolepsy patients aged seven and older. It has been granted seven years of Orphan Drug Exclusivity due to its clinical superiority over twice-nightly oxybate treatments. The drug carries a BOXED Warning for risks associated with CNS depressants and is available only through a restricted REMS program - LUMRYZ is an FDA-approved, once-at-bedtime treatment for cataplexy or EDS in adults and pediatric patients (7+) with narcolepsy[14] - The FDA granted LUMRYZ seven years of Orphan Drug Exclusivity, finding its once-nightly dosing a major contribution to patient care over twice-nightly products[16] - BOXED WARNING: Taking LUMRYZ with other CNS depressants (e.g., alcohol, sedatives) can cause serious medical problems, including respiratory depression and death[18] - Due to its active ingredient (GHB) and risk of abuse, LUMRYZ is a controlled substance available only through the restricted LUMRYZ REMS program[19][20] Financial Statements The consolidated financial statements detail Avadel's performance. The income statement shows a shift to profitability in Q2 2025 with a net income of $9.7 million. The balance sheet indicates growth in total assets to $187.2 million and shareholders' equity to $90.7 million. The cash flow statement highlights a significant improvement, with $4.5 million in cash provided by operations for the first six months of 2025, compared to a $47.9 million use of cash in the prior-year period Condensed Consolidated Statements of Income (Loss) For the three months ended June 30, 2025, Avadel reported net product revenue of $68.1 million and a net income of $9.7 million, a substantial improvement from a net loss of $13.8 million in Q2 2024. For the six-month period, net income was $4.7 million, compared to a net loss of $41.2 million in the first half of 2024 | (In thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Net product revenue | $68,129 | $41,504 | $120,640 | $68,682 | | Gross profit | $61,763 | $38,716 | $108,697 | $64,372 | | Operating income (loss) | $8,884 | ($12,741) | $5,883 | ($38,776) | | Net income (loss) | $9,665 | ($13,822) | $4,745 | ($41,164) | | Net income (loss) per share - diluted | $0.10 | ($0.14) | $0.05 | ($0.44) | Condensed Consolidated Balance Sheets As of June 30, 2025, Avadel's total assets were $187.2 million, with cash, cash equivalents, and marketable securities totaling $81.5 million. Total liabilities stood at $96.4 million, resulting in total shareholders' equity of $90.7 million, an increase from $73.8 million at year-end 2024 | (In thousands) | June 30, 2025 (Unaudited) | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $63,402 | $51,371 | | Marketable securities | $18,145 | $22,406 | | Total current assets | $159,105 | $134,208 | | Total assets | $187,157 | $164,236 | | Total current liabilities | $57,065 | $48,834 | | Total liabilities | $96,448 | $90,388 | | Total shareholders' equity | $90,709 | $73,848 | Condensed Consolidated Statements of Cash Flows For the six months ended June 30, 2025, net cash provided by operating activities was $4.5 million, a significant positive shift from the $47.9 million used in operations during the same period in 2024. The company's cash and cash equivalents increased by $12.0 million in the first half of 2025 to end at $63.4 million | (In thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $4,465 | ($47,890) | | Net cash provided by investing activities | $4,063 | $31,937 | | Net cash provided by financing activities | $1,672 | $13,913 | | Net change in cash and cash equivalents | $12,031 | ($2,320) | | Cash and cash equivalents at end of period | $63,402 | $28,847 |