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Avadel Pharmaceuticals plc(AVDL) - 2019 Q2 - Quarterly Report
2019-08-09 17:07
[PART I - FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This section presents the unaudited condensed consolidated financial information and management's analysis for the period ended June 30, 2019 [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements and related notes for the period ended June 30, 2019, detailing financial performance and position [Unaudited Condensed Consolidated Statements of Loss](index=4&type=section&id=UNAUDITED%20CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20LOSS) The company reported a significant decline in total revenues and an increased net loss for both the three and six months ended June 30, 2019 Condensed Consolidated Statements of Loss (in thousands, except per share data) | Metric | Three Months Ended June 30, 2019 | Three Months Ended June 30, 2018 | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | | :--- | :--- | :--- | :--- | :--- | | **Total Revenues** | $17,554 | $29,230 | $33,991 | $62,523 | | **Operating Loss** | ($4,451) | ($2,785) | ($12,618) | ($15,410) | | **Net Loss** | ($8,605) | ($3,438) | ($21,623) | ($15,674) | | **Net Loss Per Share - Diluted** | ($0.23) | ($0.09) | ($0.58) | ($0.42) | [Unaudited Condensed Consolidated Balance Sheets](index=6&type=section&id=UNAUDITED%20CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) Total assets decreased to $165.7 million, leading to a shareholders' deficit of $17.8 million as of June 30, 2019 Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2019 (Unaudited) | December 31, 2018 | | :--- | :--- | :--- | | **Total Current Assets** | $97,200 | $124,851 | | Cash and cash equivalents | $17,111 | $9,325 | | Marketable securities | $62,151 | $90,590 | | **Total Assets** | $165,709 | $190,300 | | **Total Current Liabilities** | $33,580 | $38,383 | | **Total Liabilities** | $183,486 | $187,520 | | **Total Shareholders' (Deficit) Equity** | ($17,777) | $2,780 | [Unaudited Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=UNAUDITED%20CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) Net cash used in operating activities improved to $22.7 million, while investing activities provided $30.3 million for the six months ended June 30, 2019 Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | | :--- | :--- | :--- | | **Net cash used in operating activities** | ($22,653) | ($37,942) | | **Net cash provided by (used in) investing activities** | $30,336 | ($79,212) | | **Net cash provided by financing activities** | $55 | $113,160 | | **Net change in cash and cash equivalents** | $7,786 | ($4,087) | | **Cash and cash equivalents at end of period** | $17,111 | $12,477 | [Notes to the Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=NOTES%20TO%20THE%20UNAUDITED%20CONDENSED%20CONSOLIDATED%20FINANCIAL%20STATEMENTS) These notes detail the company's strategic focus on FT218, the deconsolidation of a subsidiary due to bankruptcy, and significant restructuring efforts - The company's primary focus is the development and potential FDA approval of **FT218**, a Phase 3 clinical trial product for narcolepsy, alongside marketing three sterile injectable drugs[23](index=23&type=chunk)[24](index=24&type=chunk)[25](index=25&type=chunk) - On February 6, 2019, the subsidiary Avadel Specialty Pharmaceuticals, LLC filed for **Chapter 11 bankruptcy**, leading to its deconsolidation and a **$2.84 million non-cash charge**[33](index=33&type=chunk)[42](index=42&type=chunk)[43](index=43&type=chunk) - In 2019, the company initiated significant restructuring plans, including a **50% reduction in corporate workforce** and substantial reductions at its France site[110](index=110&type=chunk)[112](index=112&type=chunk) Revenue by Product (in thousands) | Product | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | | :--- | :--- | :--- | | Bloxiverz | $4,926 | $13,035 | | Vazculep | $18,883 | $24,338 | | Akovaz | $9,738 | $22,092 | | **Total Product Sales** | **$33,991** | **$62,277** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial performance, strategic focus on FT218 development, and changes in revenues, expenses, and liquidity [Overview and Business Strategy](index=33&type=section&id=Overview%20and%20Business%20Strategy) The company's core strategy centers on developing FT218 for narcolepsy, alongside marketing existing hospital injectable drugs and seeking approval for AV001 - The company's primary business strategy focuses on the development and potential FDA approval of **FT218** for narcolepsy[138](index=138&type=chunk) - Patient enrollment for the **FT218 Phase 3 REST-ON trial** is expected to be completed in the **second half of 2020**[142](index=142&type=chunk) - The FDA accepted the NDA for **AV001**, with a PDUFA target action date extended to **December 15, 2019**[147](index=147&type=chunk) [Results of Operations](index=37&type=section&id=Results%20of%20Operations) Total revenues significantly declined in Q2 2019 due to competition, partially offset by reduced SG&A expenses from the Noctiva business exit Revenue Comparison by Product - Q2 2019 vs Q2 2018 (in thousands) | Product | Q2 2019 Revenue | Q2 2018 Revenue | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Bloxiverz | $2,358 | $5,544 | ($3,186) | (57.5)% | | Vazculep | $9,410 | $11,377 | ($1,967) | (17.3)% | | Akovaz | $5,946 | $11,875 | ($5,929) | (49.9)% | | **Total Revenues** | **$17,554** | **$29,230** | **($11,676)** | **(39.9)%** | - Selling, general and administrative (SG&A) expenses decreased by **$21.1 million (75.7%)** in Q2 2019, primarily due to an **$18.1 million reduction** from the Noctiva business exit[176](index=176&type=chunk) - Research and development (R&D) expenses decreased by **$1.6 million (13.4%)** in Q2 2019, driven by lower Noctiva spending and cost reductions[174](index=174&type=chunk) - Restructuring costs increased to **$1.5 million** in Q2 2019, primarily due to the 2019 French and Corporate restructuring plans[188](index=188&type=chunk) [Liquidity and Capital Resources](index=47&type=section&id=Liquidity%20and%20Capital%20Resources) The company held $79.3 million in cash and marketable securities as of June 30, 2019, with liquidity dependent on hospital product revenue and FT218 development costs - Cash and marketable securities totaled **$79.3 million** at June 30, 2019, a **$20.7 million decrease** from December 31, 2018, primarily due to **$22.7 million cash used in operations**[159](index=159&type=chunk)[208](index=208&type=chunk) - Cash resource adequacy depends on **FT218 clinical development costs** and hospital product revenue, potentially requiring additional dilutive funding[212](index=212&type=chunk) - In February 2018, the company issued **$143.75 million** of **4.50% exchangeable senior notes due 2023**, yielding approximately **$137.6 million** in net proceeds[213](index=213&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=47&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate fluctuations on marketable securities, managed through a policy prioritizing safety and diversification - The company is subject to **interest rate risk** from its portfolio of marketable securities[223](index=223&type=chunk) - The investment policy aims to mitigate risk through **diversification**, prioritizing **safety** and **principal preservation**[223](index=223&type=chunk) [Controls and Procedures](index=47&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of June 30, 2019, following restructuring that consolidated accounting and outsourced IT - The CEO and CFO concluded the company's disclosure controls and procedures were **effective** as of **June 30, 2019**[224](index=224&type=chunk) - During Q2 2019, the company consolidated Irish and French accounting operations to St. Louis and outsourced most IT resources as part of restructuring[225](index=225&type=chunk) [PART II - OTHER INFORMATION](index=47&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This section provides additional information including legal proceedings, risk factors, and other disclosures [Legal Proceedings](index=47&type=section&id=Item%201.%20Legal%20Proceedings) This section incorporates legal proceedings by reference, primarily detailing litigation related to the subsidiary Specialty Pharma's Chapter 11 bankruptcy - Information on legal proceedings is incorporated by reference from **Note 19: Commitments and Contingencies**[226](index=226&type=chunk) - Litigation relates to the **Noctiva business**, now part of the **Chapter 11 bankruptcy** of subsidiary Specialty Pharma, including patent and contract disputes[126](index=126&type=chunk)[127](index=127&type=chunk)[128](index=128&type=chunk) [Risk Factors](index=47&type=section&id=Item%201A.%20Risk%20Factors) No material changes in risk factors have occurred since the 2018 Annual Report on Form 10-K - There have been **no material changes** in risk factors from those disclosed in the **2018 Annual Report**[227](index=227&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=47&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The authorized share buyback program was completed during the year ended December 31, 2018 - The authorized share buyback program was **completed** in the year ended **December 31, 2018**[227](index=227&type=chunk) [Defaults Upon Senior Securities](index=48&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during the reporting period - None[228](index=228&type=chunk) [Mine Safety Disclosures](index=48&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - Not applicable[228](index=228&type=chunk) [Other Information](index=48&type=section&id=Item%205.%20Other%20Information) The company reports no information for this item - None[228](index=228&type=chunk)
Avadel Pharmaceuticals plc(AVDL) - 2019 Q2 - Earnings Call Transcript
2019-08-09 16:34
Avadel Pharmaceuticals plc (NASDAQ:AVDL) Q2 2019 Earnings Conference Call August 9, 2019 8:30 AM ET Company Participants Mike Kanan - Chief Financial Officer Greg Divis - Chief Executive Officer Jordan Dubow - Chief Medical Officer Conference Call Participants François Brisebois - Laidlaw Yinglu Zhang - Ladenburg Thalmann Michael Sesser - DWS Operator Good morning, ladies and gentlemen. Thank you for standing by and welcome to the Avadel Pharmaceuticals Second Quarter 2019 Financial Results Conference Call. ...
Avadel Pharmaceuticals plc(AVDL) - 2019 Q1 - Quarterly Report
2019-05-08 20:59
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: March 31, 2019 ——————— AVADEL PHARMACEUTICALS PLC (Exact name of registrant as specified in its charter) ——————— Ireland 000-28508 98-1341933 (State or Other Jurisdiction of Incorporation) (Commission File Number) (I.R.S. Employer Identification No.) Block 10-1, Blanchardstown Corporate Park B ...
Avadel Pharmaceuticals plc(AVDL) - 2019 Q1 - Earnings Call Transcript
2019-05-08 17:36
Avadel Pharmaceuticals plc (NASDAQ:AVDL) Q1 2019 Earnings Conference Call May 8, 2019 8:30 AM ET Company Participants Greg Divis - Interim CEO Mike Kanan - CFO Jordon Dubow - CMO Geoff Glass - Chairman Conference Call Participants Operator Good morning, ladies and gentlemen, thank you for standing by. And welcome to the Avadel Pharmaceuticals’ First Quarter 2019 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session a ...
Avadel Pharmaceuticals plc(AVDL) - 2018 Q4 - Annual Report
2019-03-15 17:24
Part I [Business](index=5&type=section&id=Item%201.%20Business) Avadel Pharmaceuticals is a specialty pharmaceutical company focused on developing FT218 for narcolepsy, while also marketing three sterile injectable hospital products, following a significant 2019 restructuring - The company's primary business strategy is to focus on the development and potential FDA approval for its lead candidate, FT218, for the treatment of narcolepsy[12](index=12&type=chunk)[22](index=22&type=chunk)[281](index=281&type=chunk) Marketed Products | Product Name | Indication | | :--- | :--- | | Akovaz® | Treatment of clinically important hypotension in the setting of anesthesia | | Bloxiverz® | Reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery | | Vazculep® | Treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia | - In February 2019, Avadel initiated a corporate restructuring to focus on FT218, which included reducing its workforce by **over 50%** and the voluntary Chapter 11 bankruptcy filing of its subsidiary, Specialty Pharma, to exit the Noctiva™ business[21](index=21&type=chunk)[299](index=299&type=chunk)[598](index=598&type=chunk) - The company is developing a fourth Unapproved Marketed Drug (UMD) product, a sterile injectable for the hospital setting, with an NDA submission anticipated in the first quarter of 2019[34](index=34&type=chunk)[290](index=290&type=chunk) - The company's FT218 product candidate, which uses Micropump® technology, received Orphan Drug Designation from the FDA in January 2018, potentially providing up to **seven years** of market exclusivity if approved[26](index=26&type=chunk)[286](index=286&type=chunk) [Risk Factors](index=20&type=section&id=Item%201A.%20Risk%20Factors) Significant risks include a 2018 net loss of **$95.3 million**, recent restructuring, intense competition for hospital products, and uncertainties in the FT218 clinical trial - The company reported a net loss of **$95.3 million** and used **$82.7 million** in cash from operations in 2018, which may limit its ability to fully pursue its business strategy focused on FT218[117](index=117&type=chunk) - The recent restructuring plan, including a **50% workforce reduction** and the bankruptcy of its Specialty Pharma subsidiary, may not be as effective as anticipated and carries risks of unintended negative consequences[118](index=118&type=chunk) - A substantial majority of revenues (**96.2% in 2018**) come from three hospital products (Bloxiverz®, Vazculep®, Akovaz®) that face significant competition, pricing pressure, and declining sales[124](index=124&type=chunk)[125](index=125&type=chunk) - The clinical trial for the key product candidate, FT218, has no estimated completion date, and a management-directed evaluation could result in changes that increase costs and further delay its completion[122](index=122&type=chunk)[123](index=123&type=chunk) - Servicing the **$143.75 million** in 2023 Exchangeable Senior Notes may require significant cash, and the company may not have sufficient funds to settle exchanges, repay at maturity, or repurchase the notes if required[224](index=224&type=chunk)[225](index=225&type=chunk) [Unresolved Staff Comments](index=36&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) Not applicable, as the company has no unresolved staff comments - Not applicable[239](index=239&type=chunk) [Properties](index=36&type=section&id=Item%202.%20Properties) The company leases its research center in France, commercial and administrative offices in Missouri, and IP/supply chain operations in Ireland Leased Facilities | Location | Function | Size (sq. ft.) | Lease Expiration | | :--- | :--- | :--- | :--- | | Venissieux, France | Research Center | ~38,400 | 2022 | | Chesterfield, MO | Commercial & Admin | 24,236 | 2025 | | Dublin, Ireland | IP, Clinical, Supply Chain | 5,059 | 2025 | [Legal Proceedings](index=36&type=section&id=Item%203.%20Legal%20Proceedings) Subsidiary Avadel Specialty Pharmaceuticals, LLC, filed for Chapter 11 bankruptcy in February 2019 to exit Noctiva™ business and is involved in patent litigation with Ferring Pharmaceuticals - On **February 6, 2019**, the subsidiary Avadel Specialty Pharmaceuticals, LLC, responsible for Noctiva™, filed for voluntary Chapter 11 bankruptcy protection[243](index=243&type=chunk) - Specialty Pharma is a party in patent litigation initiated by Ferring Pharmaceuticals, which seeks to invalidate patents related to Noctiva™ and alleges trademark infringement[246](index=246&type=chunk)[249](index=249&type=chunk) - The parent company's subsidiary, Avadel US Holdings, Inc., is providing up to **$2.7 million** in debtor-in-possession financing to Specialty Pharma during the bankruptcy proceedings[244](index=244&type=chunk) [Mine Safety Disclosures](index=38&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable to the company's operations - Not applicable[250](index=250&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=39&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity,%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Avadel's ADSs trade on NASDAQ, experienced high volatility in 2018, has never paid dividends, and completed a **$50 million** share repurchase program ADS Price Range (2017-2018) | Quarter | 2018 High ($) | 2018 Low ($) | 2017 High ($) | 2017 Low ($) | | :--- | :--- | :--- | :--- | :--- | | Q1 | 11.70 | 6.76 | 12.30 | 8.87 | | Q2 | 7.78 | 5.89 | 11.72 | 8.75 | | Q3 | 7.14 | 4.08 | 11.18 | 8.14 | | Q4 | 4.66 | 1.74 | 11.53 | 7.52 | - The company has never declared or paid a cash dividend and does not anticipate doing so in the foreseeable future[256](index=256&type=chunk) - The company fully completed its authorized share buyback program of **$50 million**, with no shares repurchased during the three months ended December 31, 2018[257](index=257&type=chunk)[258](index=258&type=chunk) [Selected Financial Data](index=41&type=section&id=Item%206.%20Selected%20Financial%20Data) 2018 saw a significant financial downturn with total revenues falling to **$103.3 million**, resulting in an operating loss of **$104.9 million** and a net loss of **$95.3 million** Selected Annual Financial Data (in thousands, except per share amounts) | Metric | 2018 | 2017 | 2016 | | :--- | :--- | :--- | :--- | | Total revenues | $103,269 | $173,245 | $150,246 | | Gross profit | $85,753 | $156,944 | $136,998 | | Operating (loss) income | $(104,926) | $89,505 | $(4,965) | | Net (loss) income | $(95,304) | $68,271 | $(41,276) | | Diluted net (loss) income per share | $(2.55) | $1.63 | $(1.00) | | Total assets | $190,300 | $253,277 | $245,482 | | Long-term debt | $115,840 | $267 | $815 | - Quarterly results in 2018 show consistent operating losses, culminating in a significant operating loss of **$75.4 million** in Q4 2018, which included a **$66.1 million impairment charge**[268](index=268&type=chunk)[269](index=269&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=43&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) 2018 financial decline was driven by a **40.4% revenue drop** to **$103.3 million**, an operating loss of **$104.9 million**, a **$66.1 million impairment charge**, and a **70.5% increase in SG&A**, despite a **$143.75 million** debt issuance Revenue by Product (2018 vs. 2017, in thousands) | Product | 2018 Revenue | 2017 Revenue | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Bloxiverz | $20,850 | $45,596 | $(24,746) | (54.3)% | | Vazculep | $42,916 | $38,187 | $4,729 | 12.4% | | Akovaz | $33,759 | $80,617 | $(46,858) | (58.1)% | | Noctiva | $1,204 | $0 | $1,204 | 100.0% | | **Total Product Sales** | **$101,423** | **$172,841** | **$(71,418)** | **(41.3)%** | - Operating loss was **$104.9 million** in 2018 compared to operating income of **$89.5 million** in 2017, driven by lower gross margin, a **$66.1 million impairment** of the Noctiva intangible asset, and a **$41.5 million increase** in SG&A expenses[301](index=301&type=chunk) - SG&A expenses increased **70.5% to $100.4 million** in 2018, primarily due to approximately **$48.5 million** in sales and marketing costs for the launch of Noctiva[338](index=338&type=chunk) - R&D expenses increased **17.7% to $39.3 million** in 2018, largely due to higher spending on the FT218 Phase 3 clinical study[336](index=336&type=chunk) - Net cash used in operating activities was **$82.7 million** in 2018, a significant shift from **$16.7 million** of cash provided by operations in 2017, primarily due to lower cash earnings[357](index=357&type=chunk)[358](index=358&type=chunk) - Cash and marketable securities increased to **$99.9 million** at year-end 2018, primarily due to net proceeds of **$137.6 million** from a February 2018 debt issuance, offset by cash used in operations and share buybacks[303](index=303&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=61&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces interest rate risk on marketable securities and foreign exchange risk from its Euro-functional subsidiary, with a **10% Euro change** having an immaterial 2018 net loss impact - The company is subject to interest rate risk on its portfolio of marketable securities, which includes government and corporate bonds[379](index=379&type=chunk) - The company is exposed to foreign currency exchange risk from translating the results of its subsidiary with a Euro functional currency into U.S. dollars, where a **10% change** in the exchange rate was deemed to have an immaterial impact on 2018 net loss[380](index=380&type=chunk) [Financial Statements and Supplementary Data](index=62&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) Audited 2018 financial statements confirm a significant decline with a **$95.3 million net loss**, total assets at **$190.3 million**, total liabilities at **$187.5 million**, and shareholders' equity at **$2.8 million** Consolidated Statement of (Loss) Income (in thousands) | Line Item | 2018 | 2017 | | :--- | :--- | :--- | | Total revenues | $103,269 | $173,245 | | Total operating expenses | $208,195 | $83,740 | | Operating (loss) income | $(104,926) | $89,505 | | Net (loss) income | $(95,304) | $68,271 | | Diluted net (loss) income per share | $(2.55) | $1.63 | Consolidated Balance Sheet Highlights (in thousands) | Line Item | Dec 31, 2018 | Dec 31, 2017 | | :--- | :--- | :--- | | Cash and marketable securities | $99,915 | $94,075 | | Total assets | $190,300 | $253,277 | | Long-term debt, less current portion | $115,734 | $156 | | Total liabilities | $187,520 | $167,697 | | Total shareholders' equity | $2,780 | $85,580 | Consolidated Statement of Cash Flows Highlights (in thousands) | Line Item | 2018 | 2017 | | :--- | :--- | :--- | | Net cash (used in) provided by operating activities | $(82,716) | $16,662 | | Net cash used in investing activities | $(36,981) | $(15,698) | | Net cash provided by (used in) financing activities | $112,659 | $(23,318) | [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=113&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) Not applicable, as the company reports no changes in or disagreements with its accountants - Not applicable[613](index=613&type=chunk) [Controls and Procedures](index=113&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of **December 31, 2018**, with no material changes reported - The company's principal executive officer and principal financial officer concluded that disclosure controls and procedures were effective as of the end of the period covered by the report[613](index=613&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of **December 31, 2018**, based on the criteria set forth by COSO[616](index=616&type=chunk) [Other Information](index=113&type=section&id=Item%209B.%20Other%20Information) Not applicable, as there is no other information to report - Not applicable[617](index=617&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=114&type=section&id=Item%2010.%20Directors,%20Executive%20Officers%20and%20Corporate%20Governance) Information is incorporated by reference from the Definitive 2019 Proxy Statement - Information is incorporated by reference to the Definitive 2019 Proxy Statement[620](index=620&type=chunk) [Executive Compensation](index=114&type=section&id=Item%2011.%20Executive%20Compensation) Information is incorporated by reference from the Definitive 2019 Proxy Statement - Information is incorporated by reference to the Definitive 2019 Proxy Statement[621](index=621&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=114&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information is incorporated by reference from the Definitive 2019 Proxy Statement - Information is incorporated by reference to the Definitive 2019 Proxy Statement[622](index=622&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=114&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions,%20and%20Director%20Independence) Information is incorporated by reference from the Definitive 2019 Proxy Statement - Information is incorporated by reference to the Definitive 2019 Proxy Statement[623](index=623&type=chunk) [Principal Accountant Fees and Services](index=114&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Information is incorporated by reference from the Definitive 2019 Proxy Statement - Information is incorporated by reference to the Definitive 2019 Proxy Statement[624](index=624&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=115&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section includes financial statements, schedules for Valuation and Qualifying Accounts, and an index of all exhibits, detailing deferred tax asset valuation allowance changes for 2016-2018 - This section includes the Financial Statements, Financial Statement Schedules, and an index of all required exhibits[626](index=626&type=chunk)[627](index=627&type=chunk)[630](index=630&type=chunk) Schedule II: Valuation and Qualifying Accounts (Deferred Tax Asset Valuation Allowance, in thousands) | Year | Beginning Balance | Additions | Deductions | Other Changes | Ending Balance | | :--- | :--- | :--- | :--- | :--- | :--- | | 2018 | $15,354 | $6,089 | $(75) | $(169) | $21,199 | | 2017 | $7,599 | $391 | $(664) | $8,028 | $15,354 | | 2016 | $45,516 | $6,873 | $(42,417) | $(2,373) | $7,599 |
Avadel Pharmaceuticals plc(AVDL) - 2018 Q4 - Earnings Call Transcript
2019-03-15 15:04
Avadel Pharmaceuticals (NASDAQ:AVDL) Q4 2018 Earnings Conference Call March 15, 2019 8:30 AM ET Company Participants Greg Divis - CEO Mike Kanan - CFO Geoff Glass - Chairman Conference Call Participants Matt Kaplan - Ladenburg Thalmann Francois Brisebois - Laidlaw Operator Good morning, ladies and gentlemen, thank you for standing by. And welcome to the Avadel Pharmaceuticals’ Fourth Quarter and Full-Year 2018 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later ...