UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 22, 2018
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AVADEL PHARMACEUTICALS PLC
(Exact name of registrant as specified in its charter)
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Ireland |
001-37977 (Commission File Number) |
98-1341933 (I.R.S. Employer |
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Block 10-1 Dublin 15, Ireland |
Not Applicable (Zip Code) |
Registrant’s telephone number, including area code: +353 1 485 1200
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
| Item 5.02 | Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. |
On March 22, 2018, Avadel Pharmaceuticals plc (the “Company”) announced that, effective as of March 22, 2018, Gregory J. Divis has been promoted to Executive Vice President and Chief Operating Officer, a newly created position at the Company. Since joining the Company in January 2017, Mr. Divis, age 51, has served as Executive Vice President and Chief Commercial Officer. Mr. Divis brings to his role at the Company more than 25 years of experience in the pharmaceutical industry, and in his new positions will continue to be responsible for managing commercial strategy and execution across all of the Company’s portfolio products. Prior to joining the Company, Mr. Divis served as an Operating Partner for Linden Capital, a middle-market healthcare-focused private equity firm from June 2015 to December 2016. Prior to Linden Capital, from June 2010 to November 2014 Mr. Divis was the President and Chief Executive Officer of K-V Pharmaceutical Company (“K-V”), a company engaged in the development of proprietary drug delivery systems and formulation technologies. On August 4, 2012, K-V and certain of its subsidiaries filed voluntary petitions for reorganization under Chapter 11 of the United States Bankruptcy Code and, on September 16, 2013, successfully emerged pursuant to a plan of reorganization. Following bankruptcy, K-V changed its name to Lumara Health, Inc., strengthened its business and engaged in a series of transactions culminating in its acquisition by AMAG Pharmaceuticals in November 2014. Mr. Divis has also held such notable roles as President, Ther-Rx Corporation, Vice-President, Business Development & Lifecycle Management at Sanofi-Aventis and Vice-President and General Manager, UK and Ireland, for Schering-Plough Corporation. Mr. Divis is a graduate of the University of Iowa.
Mr. Divis entered into an employment agreement with the Company on September 5, 2017. A description of such employment agreement is set forth in the Company’s current report on Form 8-K filed with the Securities and Exchange Commission (the “SEC”) on September 11, 2017 and is incorporated herein by reference, and a copy of such employment agreement was set forth as Exhibit 10.2 to the Company’s quarterly report on Form 10-Q filed with the SEC on November 9, 2017 and is incorporated herein by reference.
| Item 8.01 | Other Events. |
On March 22, 2018, the Company issued a press release announcing the promotion of Gregory J. Divis to Executive Vice President and Chief Operating Officer of the Company. The press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| AVADEL PHARMACEUTICALS PLC | ||
| By: | /s/ Phillandas T. Thompson | |
| Phillandas T. Thompson | ||
| Senior Vice President, General Counsel and Corporate Secretary | ||
Date: March 22, 2018
Exhibit Index
| 99.1 | Press release dated March 22, 2018, issued by Avadel Pharmaceuticals plc |
Exhibit 99.1
Avadel Pharmaceuticals Announces Promotion of Gregory J. Divis to Chief Operating Officer
Dublin, Ireland – March 22, 2018 – Avadel Pharmaceuticals plc (NASDAQ: AVDL), “Avadel” or the “Company,” today announced the promotion of Gregory J. Divis to Executive Vice President and Chief Operating Officer, a newly created role at the Company. Mr. Divis has served as the Company’s Chief Commercial Officer since joining in January of 2017. He brings more than 25 years of experience in the pharmaceutical industry to the role and will be responsible for overseeing Avadel’s U.S. and European-based operations, including Supply Chain, Business Development, and Commercial Operations.
Mike Anderson, Avadel’s Chief Executive Officer, commented, “Greg has meaningful experience across a number of operational functions, and his role has expanded since his arrival last January. His involvement in everything from our supply chain activities, business development, and commercial activities has contributed tremendous value to our organization as he transitions into this new leadership role. I look forward to continuing my work with Greg as we execute our vision of becoming a leading specialty pharma company.”
Greg Divis, said, “As we continue to grow and broaden our offering of new and differentiated products, I look forward to expanding my involvement across our organization. Avadel has a number of exciting upcoming catalysts, including the launch of Noctiva™ and completion of our REST-ON Phase III trial. The successful execution of these strategic objectives will transform our company, drive long-term value creation, and aid us in our mission to improve the lives of the patients we serve.”
Mr. Divis served as President and Chief Executive Officer of Lumara Health, a specialty branded pharmaceutical company focused on women’s health, from 2010 to 2014. At Lumara, Mr. Divis led the successful turnaround and transformation of the business resulting in a series of transactions culminating in the successful sale to AMAG Pharmaceuticals. Mr. Divis has also held such notable roles as Vice-President, Business Development & Lifecycle Management at Sanofi-Aventis and as Vice-President and General Manager, UK and Ireland, for Schering-Plough Corporation. Mr. Divis is a graduate of the University of Iowa.
About Avadel Pharmaceuticals plc:
Avadel Pharmaceuticals plc (NASDAQ: AVDL) is a specialty pharmaceutical company that seeks to develop differentiated pharmaceutical products that are safe, effective and easy to take through formulation development, by utilizing its proprietary drug delivery technology and through in-licensing / acquiring new products; ultimately, helping patients adhere to their prescribed medical treatment and see better results. The Company is headquartered in Dublin, Ireland with operations in St. Louis, Missouri and Lyon, France. For more information, please visit www.avadel.com.
Safe Harbor: This press release 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. The words “will,” “may,” “believe,” “expect,” “anticipate,” “estimate,” “project” and similar expressions, and the negatives thereof, identify forward-looking statements, each of which speaks only as of the date the statement is made. Although we believe that our forward-looking statements are based on reasonable assumptions within the bounds of our knowledge of our business and operations, our business is subject to significant risks and as a result there can be no assurance that actual results of our research, development and commercialization activities and our results of operations will not differ materially from the results contemplated in such forward-looking statements. These risks include: (i) risks that we may not achieve our goals of becoming a leading specialty pharma company, including by continuing to grow and broaden our offering of new and differentiated products, launch Noctiva, complete our REST-ON Phase III clinical trial, transform our company and drive long-term value creation; and (ii) the other risks, uncertainties and contingencies described in the Company's filings with the U.S. Securities and Exchange Commission, including our annual report on Form 10-K for the year ended December 31, 2017, in particular disclosures that may be set forth in particular under the captions “Forward-Looking Statements” and “Risk Factors,” including without limitation: our dependence on a small number of products and customers for the majority of our revenues; numerous risks related to our efforts to successfully commercialize our new Noctiva™ product; the possibility that our Bloxiverz®,Vazculep® and Akovaz® products, which are not patent protected, could face increased competition resulting in a further loss of market share or forcing us to reduce the prices we charge for those products; the possibility that we could fail to successfully complete the research and development for pipeline products we are evaluating for potential application to the FDA pursuant to our "unapproved-to-approved" strategy, or that competitors could complete the development of such products and apply for FDA approval of such products before us; the possibility that our products may not reach the commercial market or gain market acceptance; our need to invest substantial sums in research and development in order to remain competitive; our dependence on certain single providers for development of several of our drug delivery platforms and products; our dependence on a limited number of suppliers to manufacture our products and to deliver certain raw materials used in our products; the possibility that our competitors may develop and market technologies or products that are more effective or safer than ours, or obtain regulatory approval and market such technologies or products before we do; the challenges in protecting the intellectual property underlying our drug delivery technologies and other products; and our dependence on key personnel to execute our business plan.
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| Contacts: | Michael F. Kanan |
Chief Financial Officer
Phone: (636) 449-1844
Email: mkanan@avadel.com
Lauren Stival
Sr. Director, Investor Relations and Corporate Communications
Phone: (636) 449-5866
Email: lstival@avadel.com