Core Viewpoint - Avadel Pharmaceuticals plc has received an unsolicited acquisition proposal from H. Lundbeck A/S, offering up to $23.00 per ordinary share, which includes $21 in cash and a contingent value right of $2 per share [1][2]. Group 1: Proposal Details - The Lundbeck proposal consists of $21 per share in cash and a non-transferable contingent value right (CVR) that could provide an additional $2 per share [2]. - Avadel's Board of Directors believes that the Lundbeck proposal could potentially be a "Company Superior Proposal" compared to its existing agreement with Alkermes plc [3]. Group 2: Existing Agreement with Alkermes - Alkermes had previously agreed to acquire Avadel for up to $20 per share in cash, valuing the company at approximately $2.1 billion, which includes $18.50 per share in cash and an additional $1.50 per share contingent on FDA approval of Lumryz by the end of 2028 [4]. - The board has stated that while they can engage in discussions with Lundbeck, they cannot terminate the agreement with Alkermes or finalize any deal with Lundbeck at this time [5]. Group 3: Market Reaction - Following the news of the Lundbeck proposal, Avadel Pharmaceuticals shares increased by 20.22%, reaching a new 52-week high of $23.13 [6].

Core Viewpoint - Avadel Pharmaceuticals' stock price surged over 20% following an unsolicited acquisition proposal from Lundbeck, which offers up to $23 per share, surpassing Alkermes' previous offer of $20 per share [1] Company Summary - Avadel Pharmaceuticals' stock reached $23.215 as of the latest report, reflecting a significant market response to the acquisition proposal [1] - The company has not yet determined if Lundbeck's proposal is superior to the existing offer from Alkermes and has not changed its recommendation regarding Alkermes' acquisition plan [1] Industry Summary - The competitive landscape in the pharmaceutical sector is highlighted by the unsolicited bid from Lundbeck, indicating active M&A interest in the sleep medication market [1] - The contrasting offers from Lundbeck and Alkermes illustrate the ongoing strategic maneuvers among companies in the biopharmaceutical industry [1]

Core Viewpoint - Avadel Pharmaceuticals' stock surged over 20% following an unsolicited acquisition proposal from Lundbeck, offering up to $23 per share, which is higher than Alkermes' previous offer of $20 per share [1] Group 1: Company Developments - Avadel Pharmaceuticals' stock price reached $23.215 after the announcement of the acquisition proposal [1] - Lundbeck's offer of up to $23 per share is significantly higher than the previous offer from Alkermes, which was capped at $20 per share [1] - Despite the positive market reaction, Avadel's board has not yet determined if Lundbeck's proposal is superior to Alkermes' offer and has not changed its recommendation regarding the Alkermes acquisition [1]

Core Insights - A bidding war is emerging in the biotech sector, with Avadel Pharmaceuticals (AVDL) at the center, as Alkermes (ALKS) faces competition from Lundbeck for a potential acquisition [1][2] Group 1: Acquisition Offers - Lundbeck has made an unsolicited bid for Avadel worth up to $2.4 billion, valuing Avadel stock at $23 per share, which includes $21 in cash and $2 tied to contingent value rights (CVRs) [2] - Avadel previously agreed to a $2.1 billion takeover deal from Alkermes, which valued the stock at up to $20 per share, consisting of $18.50 in cash and CVRs worth up to $1.50 per share [2] Group 2: Market Reactions - Following Lundbeck's offer, Avadel's stock surged over 20% to $23.16, while Alkermes' stock fell more than 6% to $29 [4] Group 3: Financial Capacities - Alkermes has $1.1 billion in cash and no debt, with an EBITDA of $380 million, giving it a theoretical deal capacity of $2.7 billion [5] - Lundbeck has $550 million in cash and $1.9 billion in debt, with an EBITDA of $1.3 billion, resulting in a theoretical deal capacity of $3.8 billion [5] Group 4: Contingent Value Rights and Sales Milestones - Lundbeck's deal includes aggressive sales milestones requiring Lumryz and valiloxybate to achieve at least $450 million in U.S. sales annually by 2027 and $700 million before 2030 [7] - Analysts estimate Lumryz will generate $399 million in 2027 and $581 million by 2030, which is below Lundbeck's required sales milestones [7]

Core Viewpoint - Alkermes is currently evaluating its options with advisers following the unsolicited takeover proposal received by Avadel Pharmaceuticals from Danish pharmaceutical company Lundbeck [1] Group 1 - Alkermes is reviewing its strategic options in light of the recent developments involving Avadel Pharmaceuticals [1] - The unsolicited takeover proposal from Lundbeck indicates potential consolidation activity within the pharmaceutical industry [1]

Core Viewpoint - Avadel Pharmaceuticals has received an unsolicited acquisition proposal from H. Lundbeck A/S, offering up to $23.00 per ordinary share, which includes cash and contingent value rights, leading the Board to consider it a potential "Company Superior Proposal" compared to its existing agreement with Alkermes [3][5]. Summary by Sections Acquisition Proposal - Lundbeck's proposal includes $21.00 in cash per ordinary share at closing and contingent value rights that could provide an additional $2.00 per share based on sales milestones for LUMRYZ™ and valiloxybate [3]. - The proposal is contingent upon various closing conditions, including shareholder and regulatory approvals [3]. Existing Agreement with Alkermes - Avadel has a definitive transaction agreement with Alkermes, under which shareholders would receive up to $20.00 per ordinary share, consisting of $18.50 in cash and a contingent value right of $1.50 [4]. - The Board's determination regarding Lundbeck's proposal allows for discussions but does not permit Avadel to terminate its agreement with Alkermes [5]. Board's Position - The Board has not yet confirmed that Lundbeck's proposal constitutes a Company Superior Proposal under the existing agreement with Alkermes and has not changed its recommendation in support of the Alkermes acquisition [5][6]. - There is no assurance that discussions with Lundbeck will lead to a definitive agreement [6]. Financial Advisors - Morgan Stanley and Goldman Sachs are serving as financial advisors to Avadel in relation to the acquisition discussions [9][23].

Key Information - The discloser is Avadel Pharmaceuticals plc, which is the offeree in relation to its relevant securities [2][4] - The position was held as of November 4, 2025 [2] - There are no interests or short positions disclosed for the relevant securities [4] Interests and Short Positions - No relevant securities owned or controlled by the discloser [4] - No cash-settled or stock-settled derivatives reported [4] - Total interests and short positions are NIL [4] Interests of Persons Acting in Concert - Total interests held by directors of Avadel Pharmaceuticals plc amount to 794,959 ordinary shares, representing 0.81% of the total issued ordinary share capital [6] - The total number of underlying stock options and other rights held by these directors is 4,347,557 [6] Other Information - No indemnity or other dealing arrangements were reported [9] - No agreements or arrangements relating to options or derivatives were disclosed [9] - A Supplemental Form 8 is not attached [10]

Group 1 - Avadel Pharmaceuticals plc (AVDL) has been added to the Zacks Rank 5 (Strong Sell) List, with a 20.8% downward revision in the Zacks Consensus Estimate for its current year earnings over the last 60 days [1] - Evolution Petroleum Corporation (EPM) is also on the Zacks Rank 5 (Strong Sell) List, experiencing an 89% downward revision in the Zacks Consensus Estimate for its current year earnings over the last 60 days [1] - FMC Corporation (FMC) has seen a 5.5% downward revision in the Zacks Consensus Estimate for its current year earnings over the last 60 days [2]

Financial Performance - Net product revenue for the three and nine months ended September 30, 2025, was $77,467 and $198,107, respectively, compared to $50,025 and $118,707 for the same periods in 2024, indicating a significant increase driven by the early phases of LUMRYZ launch [187]. - Gross profit for the three and nine months ended September 30, 2025, was $81,583 and $190,280, respectively, compared to $43,870 and $108,242 for the same periods in 2024, reflecting a decrease in the cost of products sold [187]. - Operating income for the nine months ended September 30, 2025, was $7,820, a significant improvement from an operating loss of $39,102 in the same period of 2024 [191]. - Diluted net income per share for the nine months ended September 30, 2025, was $0.05, compared to a diluted net loss per share of $0.46 in the same period of 2024 [191]. - The net income for the nine months ended September 30, 2025, was $4,765, contributing to the positive cash flow from operating activities [203]. - Cash, cash equivalents, and marketable securities increased by $17,800 to $91,577 as of September 30, 2025, primarily due to net cash provided by operating activities of $26,670 [190]. - Net cash provided by operating activities for the nine months ended September 30, 2025, was $26,670, a significant increase of $81,450 or 148.7% compared to a net cash used of $54,780 in the same period of 2024 [202][203]. - Investment and other income, net decreased by $2,219 or 71.3% during the nine months ended September 30, 2025, primarily due to lower interest income and higher foreign exchange losses [198]. - Income tax benefit increased by $2,731 or 835.2% during the nine months ended September 30, 2025, driven by the release of uncertain tax positions [200]. Product Development and Regulatory Approvals - LUMRYZ received FDA approval on May 1, 2023, for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy, with seven years of Orphan Drug Exclusivity granted until May 1, 2030 [175]. - A pivotal trial named REVITALYZ has been initiated to evaluate the efficacy and safety of LUMRYZ in treating idiopathic hypersomnia, with an expected enrollment of approximately 150 adults and completion anticipated by the end of 2025 [179]. - LUMRYZ has been granted Orphan Drug Designation for the treatment of idiopathic hypersomnia, based on its potential clinical superiority due to its once-nightly dosing regimen [181]. Expenses and Financial Management - Research and development expenses increased by $24,697 or 226.1% during the nine months ended September 30, 2025, primarily due to $20,000 upfront license fees to XWPharma and costs associated with clinical trials [195]. - Selling, general and administrative expenses rose by $10,419 or 7.6% during the nine months ended September 30, 2025, driven by higher employee-related costs and commercial expenses for LUMRYZ [197]. - The company has a history of net losses from operations, although it was profitable in the quarters ended June 30, 2025, and September 30, 2025 [187]. Strategic Agreements and Transactions - A Settlement and License Agreement was entered into with Jazz Pharmaceuticals on October 21, 2025, resolving multiple lawsuits related to LUMRYZ [182]. - A Transaction Agreement was announced with Alkermes on October 22, 2025, under which Alkermes will acquire Avadel for $18.50 in cash per share, plus a potential additional cash payment of $1.50 per share contingent on specified milestones [183][184]. - The transaction with Alkermes is expected to close in the first quarter of 2026, subject to customary closing conditions including shareholder approval and antitrust clearances [185]. - The company has entered into a Transaction Agreement with Alkermes, which imposes certain operational restrictions but does not hinder funding for operations and capital expenditures [201]. Market and Competitive Landscape - The competitive landscape includes the launch of authorized generic versions of sodium oxybate, which may impact LUMRYZ's market position [187]. - The number of patients treated with LUMRYZ increased to approximately 3,400 as of September 30, 2025, compared to approximately 2,300 patients a year earlier [192]. Cash Flow and Capital Management - Net cash used in investing activities was $4,370 for the nine months ended September 30, 2025, compared to net cash provided of $36,867 in the same period of 2024, reflecting a change of $41,237 or (111.9)% [202][204]. - Net cash provided by financing activities was $4,179 for the nine months ended September 30, 2025, a decrease of $10,911 or (72.3)% from $15,090 in the same period of 2024 [202][205]. - The company anticipates sufficient capital from existing cash, cash equivalents, and marketable securities, along with expected sales from LUMRYZ, to meet operating and capital requirements for the next twelve months [207]. Legal and Regulatory Considerations - The company is subject to potential liabilities from lawsuits and claims, but there were no contingent liabilities as of September 30, 2025, that could materially affect financial position [208]. - The company does not believe inflation had a material effect on its financial condition or results of operations during the nine months ended September 30, 2025, but acknowledges potential future impacts [212]. - A 10% change in foreign currency exchange rates related to euro-denominated assets would have had an immaterial impact on net income for the nine months ended September 30, 2025 [210].

Revenue and Profitability - Generated LUMRYZ™ net product revenue of $77.5 million, a 55% increase compared to third quarter 2024[6] - Net product revenue for Q3 2025 was $77.467 million, a 54.7% increase from $50.025 million in Q3 2024[41] - Gross profit for the quarter was $81.6 million, or 105% of net product revenue, compared to $43.9 million, or 88% of net product revenue, for the same period in 2024[11] - Gross profit for Q3 2025 reached $81.583 million, compared to $43.870 million in Q3 2024, reflecting a significant improvement[41] - Operating income for the nine months ended September 30, 2025, was $7.820 million, a turnaround from a loss of $39.102 million in the same period of 2024[41] - Net income for the quarter was $20 thousand, or $0.00 per diluted share, compared to a net loss of $2.6 million, or ($0.03) per diluted share, for the same period in 2024[14] - Net income for the nine months ended September 30, 2025, was $4.765 million, compared to a loss of $43.789 million in the same period of 2024[41] Expenses - Research and development expenses for the quarter were $27.0 million compared to $3.8 million for the same period in 2024[12] - Selling, general and administrative expenses for the quarter were $52.6 million compared to $40.4 million for the same period in 2024[13] - Research and development expenses surged to $27.010 million in Q3 2025, up from $3.803 million in Q3 2024, indicating increased investment in innovation[41] Cash and Assets - Cash, cash equivalents, and marketable securities were $91.6 million at September 30, 2025, compared to $81.5 million at June 30, 2025[15] - Cash and cash equivalents increased to $79.813 million as of September 30, 2025, up from $51.371 million at the end of 2024[43] - Total assets grew to $199.448 million as of September 30, 2025, compared to $164.236 million at the end of 2024[43] - Total liabilities increased to $101.223 million as of September 30, 2025, from $90.388 million at the end of 2024[43] - Net cash provided by operating activities for the nine months ended September 30, 2025, was $26.670 million, a significant improvement from a cash outflow of $54.780 million in the same period of 2024[45] - The company reported a net change in cash and cash equivalents of $28.442 million for the nine months ended September 30, 2025[45] Patient and Market Developments - Approximately 3,400 patients on LUMRYZ as of September 30, 2025, a 48% increase compared to September 30, 2024[6] - A global settlement with Jazz Pharmaceuticals was announced, allowing Avadel to commercialize LUMRYZ for indications beyond narcolepsy starting March 1, 2028[9] - Patient enrollment in the REVITALYZ study is on track to be completed by the end of 2025[7] Corporate Transactions - Avadel entered into a definitive agreement with Alkermes for a total transaction consideration of up to $20.00 per share, valuing Avadel at approximately $2.1 billion[2]