Shares of Avadel (AVDL) have gained 32.7% over the past four weeks to close the last trading session at $12.75, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $17.5 indicates a potential upside of 37.3%.The mean estimate comprises eight short-term price targets with a standard deviation of $3.38. While the lowest estimate of $12.00 indicates a 5.9% decline from the current pric ...

Financial Data and Key Metrics Changes - The company reported net revenue of $68.1 million for Q2 2025, reflecting a 64% year-over-year increase and a 30% sequential growth compared to Q1 2025 [18][22] - Gross profit for the quarter was $61.8 million, showing a 60% increase year-over-year and a 32% increase sequentially [18][22] - The company achieved net income of $9.7 million, or $0.10 per diluted share, marking the first net income since the launch of Lumerize [22] - Cash generated during the quarter was $15 million, with total cash, cash equivalents, and marketable securities amounting to $81.5 million at the end of the quarter [22] Business Line Data and Key Metrics Changes - The number of active patients on Lumerize reached 3,100 as of June 30, 2025, representing a 63% increase compared to the same quarter last year [5] - Lumerize net revenue for the quarter was $68.1 million, a 64% year-over-year increase [5][6] - The company raised its full-year revenue guidance for 2025 to between $265 million and $275 million, up from the previous guidance of $255 million to $265 million [17][18] Market Data and Key Metrics Changes - The company noted a significant unmet medical need in idiopathic hypersomnia (IH), with approximately 42,000 diagnosed patients currently limited to a single FDA-approved therapy [8] - The company received orphan drug designation from the FDA for Lumerize's use in IH, which could potentially expand the market significantly [7][8] Company Strategy and Development Direction - The company is focused on expanding Lumerize's market presence and pursuing additional indications, particularly in idiopathic hypersomnia [6][10] - Investments are being made to enhance commercial execution and patient demand for Lumerize, including expanding the sales force and increasing marketing efforts [15][20] - The company is also pursuing a low or no sodium extended release formulation to complement its existing product offerings [10][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of Lumerize, citing positive trends in patient demand and improvements in key metrics such as persistency and reimbursement rates [6][18] - The company is optimistic about the potential for Lumerize to transform the treatment landscape for IH and improve patient care [9][10] - Management highlighted the importance of their intellectual property portfolio in protecting Lumerize and its innovations [25] Other Important Information - The company is actively pursuing legal actions against Jazz Pharmaceuticals to protect its rights and intellectual property, including an antitrust case scheduled for trial [11][25] - The company is committed to leveraging its commercial platform to maximize the potential of Lumerize and explore future business development opportunities [93] Q&A Session Summary Question: Guidance and quarterly trajectory - Management indicated that the guidance reflects expectations for continued patient growth and improvements in key metrics, with the potential for future adjustments based on performance [29][30] Question: Patient initiation and dropout rates - Management noted that improvements in persistency were observed in Q2, and they expect these trends to continue, driven by tailored patient support [32][33] Question: Annualized net revenue per patient and inventory impact - The annualized net revenue per patient was approximately $92,000, with no significant impact from inventory stocking on revenue [39][40] Question: Impact of orexin on narcolepsy business - Management views oxybates as complementary to orexin therapies, emphasizing the ongoing importance of oxybates in treating narcolepsy [50][51] Question: Market sizing and growth rates - Management noted that the oxybate market is growing, driven by increased awareness and diagnosis rates, with Lumerize attracting new patients [56][58] Question: Promotional strategies for idiopathic hypersomnia - Management highlighted the overlap in prescribers for narcolepsy and IH, indicating a strong promotional strategy leveraging existing relationships [72][75] Question: Current mix of switch and naive patients - Over half of the patients on therapy are switch patients, with management encouraged by the adoption cycle and growth from both switch and new patients [81][84]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ——————— FORM 10-Q ——————— ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37977 AVADEL PHARMACEUTICALS PLC (Exact name of registrant as specified in its charter) ——————— Ireland 98-1341933 (State ...

AVADEL Pharmaceuticals plc (NASDAQ: AVDL) Second Quarter 2025 Earnings Slides Safe Harbor Statements This presentation may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects or other events. Such forward-looking statements include, but are not li ...

[Q2 2025 Highlights and Updated 2025 Guidance](index=1&type=section&id=Second%20Quarter%20Highlights%20and%202025%20Guidance) 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](index=3&type=chunk)[4](index=4&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Overview%20of%20Second%20Quarter%20Financial%20Results) 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](index=4&type=chunk)[11](index=11&type=chunk) - Q2 2025 marked the **first quarter the company has generated net income** since LUMRYZ was launched[10](index=10&type=chunk) [Corporate and Pipeline Updates](index=1&type=section&id=Corporate%20and%20Pipeline%20Updates) 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](index=13&type=chunk) - 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](index=13&type=chunk) - LUMRYZ was granted FDA Orphan Drug Designation for the treatment of Idiopathic Hypersomnia (IH)[3](index=3&type=chunk)[13](index=13&type=chunk) - 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](index=3&type=chunk)[13](index=13&type=chunk) [About LUMRYZ™](index=3&type=section&id=About%20LUMRYZ) 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](index=14&type=chunk) - 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](index=16&type=chunk) - **BOXED WARNING**: Taking LUMRYZ with other CNS depressants (e.g., alcohol, sedatives) can cause serious medical problems, including respiratory depression and death[18](index=18&type=chunk) - Due to its active ingredient (GHB) and risk of abuse, LUMRYZ is a controlled substance available only through the restricted LUMRYZ REMS program[19](index=19&type=chunk)[20](index=20&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) 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)](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20INCOME%20(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](index=7&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) 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](index=8&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) 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 |

Core Viewpoint - The U.S. Court of Appeals affirmed the FDA's approval of LUMRYZ, validating its innovative formulation and clinical superiority for treating narcolepsy [1][2][3] Company Overview - Avadel Pharmaceuticals plc is focused on transforming medicines to improve patient lives, with LUMRYZ being its commercial product approved for narcolepsy treatment [20] - The company aims to expand the patient base for LUMRYZ beyond the current thousands treated [2] Product Details - LUMRYZ is the first and only once-at-bedtime oxybate treatment for cataplexy or excessive daytime sleepiness in patients aged 7 and older with narcolepsy, approved by the FDA on May 1, 2023 [4][20] - The FDA granted LUMRYZ 7 years of Orphan Drug Exclusivity due to its clinical superiority over existing treatments [6] Clinical Evidence - The approval of LUMRYZ was supported by the REST-ON™ Phase 3 trial, which showed significant improvements in excessive daytime sleepiness, overall patient functioning, and cataplexy attacks compared to placebo [5] - The once-at-bedtime dosing regimen of LUMRYZ is clinically superior to first-generation immediate-release oxybates, providing a major contribution to patient care [2][6]

Core Viewpoint - An investor is pushing for a complete board overhaul at Avadel Pharmaceuticals due to perceived mismanagement, particularly regarding the launch of its primary narcolepsy treatment, which has led to significant revenue losses [1][2]. Group 1: Company Management and Governance - ASL Strategic Value Fund intends to call for a shareholder vote to remove the entire board of directors at Avadel Pharmaceuticals, indicating rising dissatisfaction with management [1]. - The fund plans to release an open letter detailing claims that Avadel has mismanaged the launch of its main treatment, resulting in missed revenue opportunities amounting to hundreds of millions of dollars [2]. Group 2: Competitive Landscape - Avadel Pharmaceuticals has been engaged in ongoing litigation with its largest competitor in the narcolepsy treatment market, highlighting the competitive pressures the company faces [3].

LUMRYZ Opportunity and Strategy - LUMRYZ aims to transform the narcolepsy treatment market and Avadel into a high-growth biopharmaceutical company[5] - The company has a clear strategy for significant growth and value creation, building on a strong foundation[8] - Avadel has a focused strategy with clear priorities, including driving demand, securing reimbursement, and investing in lifecycle management[20, 21, 22] - LUMRYZ has significant potential for future peak revenue, potentially exceeding $1 billion, with a target market share of 50-60% and a potential patient base exceeding 10,000[27, 28] LUMRYZ Differentiation and Clinical Data - LUMRYZ is a new and highly differentiated treatment for narcolepsy, addressing an unmet need for a once-at-bedtime oxybate[6, 13] - 94% of patients who switched from first-generation oxybates prefer LUMRYZ dosing[13] - The FDA has determined LUMRYZ to be clinically superior to twice-nightly oxybates, granting it Orphan Drug Exclusivity (ODE)[13, 63] - Clinical data supports LUMRYZ's efficacy, with the REST-ON Phase III study achieving statistical significance (P<0.001) for all three co-primary endpoints[57] Launch and Market Dynamics - The oxybate narcolepsy market has plateaued at approximately $18 billion with approximately 16,000 patients[178] - Approximately 45% of oxybate-naive patients refuse first-generation oxybates when offered[186] - Market research indicates that LUMRYZ has the potential to expand the new-to-oxybate patient market by +35% to 113%[84] - The company's field team has reached approximately 1,100 sleep specialist offices, representing 66% of top-tier targets[250]

Avadel (AVDL) closed the last trading session at $9.57, gaining 6.2% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $17.38 indicates an 81.6% upside potential.The mean estimate comprises eight short-term price targets with a standard deviation of $3.70. While the lowest estimate of $12 indicates a 25.4% increase from the current price level, the most optimistic analyst expects the ...

Core Viewpoint - Avadel (AVDL) is positioned as a strong investment opportunity due to its significantly improving earnings outlook, with analysts raising their earnings estimates for the company [1][2]. Estimate Revisions - The upward trend in earnings estimate revisions indicates growing analyst optimism regarding Avadel's earnings prospects, which is expected to positively influence its stock price [2]. - For the current quarter, Avadel is projected to earn $0.01 per share, reflecting a remarkable increase of +107.14% from the previous year [5]. - Over the last 30 days, the Zacks Consensus Estimate for Avadel has surged by 493.29%, with one estimate moving higher and no negative revisions [5]. - For the full year, the earnings estimate stands at $0.18 per share, representing a change of +135.29% from the year-ago figure [6]. - The consensus estimate for the current year has increased by 55.03% due to one upward revision and no negative changes [6][7]. Zacks Rank - Avadel has achieved a Zacks Rank 2 (Buy), supported by favorable estimate revisions, indicating strong potential for outperformance compared to the S&P 500 [8]. - The Zacks Rank system has a proven track record, with Zacks 1 Ranked stocks averaging an annual return of +25% since 2008 [3][8]. Stock Performance - Avadel shares have increased by 5.1% over the past four weeks, suggesting investor confidence in the company's earnings growth prospects [9].