UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or Section 15(d)
of the Securities Exchange Act of 1934
Date
of report (Date of earliest event reported): February 17, 2021 (
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Securities registered pursuant to Section 12(b) of the Act:
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Ordinary Shares, nominal value $0.01 per share** |
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*American Depositary Shares may be evidenced by American Depositary Receipts. Each American Depositary Share represents one (1) Ordinary Share.
** Not for trading, but only in connection with the listing of American Depositary Shares on The Nasdaq Global Market.
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.
Appointment of Chief Commercial Officer
On February 17, 2021, Avadel Pharmaceuticals plc (the “Company”) announced that Richard Kim has been appointed as Chief Commercial Officer, effective as of February 15, 2021.
As Chief Commercial Officer, Mr. Kim will be paid an annual base salary of $425,000 and will be eligible to receive an annual performance-based bonus equal to 45% of his base salary. In connection with his appointment, Mr. Kim was granted stock options to purchase 350,000 shares of the Company’s American Depositary Shares (the “Equity Award”). The Equity Award will vest in equal installments over a four-year period beginning on February 15, 2022. Mr. Kim will enter into an employment agreement with the Company at a later date.
Prior to joining the Company, Mr. Kim, 51, served as President, U.S. Commercial & Strategic Marketing of Intercept Pharmaceuticals, Inc., a pharmaceuticals company, from February 2018 to January 2021 having previously served as Intercept’s Senior Vice President, Commercial U.S. since July 2015. Prior to his time at Intercept, Mr. Kim worked at Bristol-Myers Squibb starting in 2004, where he held a number of roles of increasing responsibility. Mr. Kim earned his bachelor’s degree in chemistry from the University of Alberta.
There are no arrangements or understandings between Mr. Kim and any other person pursuant to which he was appointed as an executive officer of the Company, and there are no relationships between Mr. Kim and the Company that would require disclosure under Item 404(a) of Regulation S-K.
A copy of the Company’s press release announcing the appointment of Mr. Kim as Chief Commercial Officer is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
| Item 9.01. | Exhibits |
(d) Exhibits
| 99.1 | Press Release Issued by the Company on February 17, 2021. |
| 104 | Cover Page Interactive Data File (embedded with the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| February 17, 2021 | AVADEL PHARMACEUTICALS PLC | ||
| By: | /s/ Jerad G. Seurer | ||
| Name: | Jerad G. Seurer | ||
| Title: | Vice President, Legal Affairs & Corporate Secretary | ||
Exhibit 99.1
Avadel Pharmaceuticals Appoints Richard Kim as Chief Commercial Officer to Lead the Commercial Launch of Once-Nightly FT218
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DUBLIN, Ireland, February 17, 2021 -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy, today announced the appointment of Richard Kim to the newly formed role of Chief Commercial Officer. In this role his responsibilities will include leading all aspects of the U.S. commercial launch of the company’s lead program, once-nightly FT218, pending regulatory approval.
“Richard joins our team at an important point in the company’s history,” said Greg Divis, Chief Executive Officer of Avadel. “Richard has over 25 years of biopharmaceutical commercial experience with direct leadership of successful product launches in the U.S. and around the world to treat specialty and orphan diseases. His hands-on experience in building world-class teams, capabilities and infrastructure to support the commercial launches of those innovative new drugs will play a critical role at Avadel as we accelerate our commercialization strategy for once-nightly FT218, in preparation for the highly anticipated U.S. regulatory approval.”
“I was drawn to Avadel because of the potential its investigational, once-nightly FT218 product offers as a game changing therapy for patients living with narcolepsy,” said Mr. Kim. “I am excited to have the opportunity to work alongside the amazing Avadel team and build upon the positive momentum they have already established for the once-nightly FT218 program, including completion of the pivotal phase 3 study, submission of the NDA to the FDA at the end of last year, and the ongoing preparation for a successful commercial launch.”
“It isn’t often that a new product has the potential to offer such a significant advancement in patient care for an established multi-billion dollar market. If approved, I believe FT218 will be the preferred choice for sodium oxybate drug therapy and provide a potentially life-changing option for narcolepsy patients, while creating value for our shareholders,” concluded Mr. Kim.
Mr. Kim has over 25 years of commercialization, marketing, development and managerial experience in the biopharmaceutical industry in the U.S. and abroad. Prior to joining Avadel, he was at Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), where he most recently served as the President of U.S. Commercial & Strategic Marketing. During his time there he helped to successfully launch OCALIVA™ (obeticholic acid), the first new treatment in nearly 20 years in an orphan disease, Primary Billiary Cholangitis, and led the launch strategy for obeticholic acid for the treatment of NASH. Prior to joining Intercept, Mr. Kim worked at Bristol-Myers Squibb, where he served as General Manager, Hepatitis C Worldwide Commercialization where he led the successful worldwide launch of DAKLINZA™ (daclatasvir) for hepatitis C. Prior to this, Mr. Kim held a number of roles of increasing responsibility leading sales, operational and strategic marketing teams at Bristol-Myers Squibb, including Vice President, SPRYCEL™ Brand Lead, Oncology Global Marketing; Vice President, U.S. In-Line Oncology and Global Marketing; and Vice President, East Area Sales, Cardiovascular and Metabolics. Prior to his time at Bristol-Myers Squibb, Mr. Kim held a range of senior positions in the U.S., Canada and Australia at Schering-Plough, which was acquired by Merck & Co., Inc.
About FT218
FT218 is an investigational, once-nightly formulation of sodium oxybate that includes Avadel’s MicroPump™ controlled-release (CR) technology. In December 2020, the Company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for FT218 to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product.
About Avadel Pharmaceuticals plc:
Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company primarily focused on the development and FDA approval of FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. For more information, please visit www.avadel.com.
Cautionary Disclosure Regarding Forward-Looking Statements
This press release includes “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 limited to, the FDA’s review of the NDA for FT218, the benefits of Orphan Drug Exclusivity for FT218, if granted by the FDA, the commercial launch of FT218, if approved, and market acceptance of FT218, if approved. In some cases, forward-looking statements can be identified by the use of words such as “will,” “may,” “could,” “believe,” “expect,” “look forward,” “on track,” “guidance,” “anticipate,” “estimate,” “project,” “next steps” and similar expressions, and the negatives thereof (if applicable).
Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include the risk that the FDA does not approve the NDA for FT218 or such approval is delayed, the risk that FT218 (if approved) may not receive a 7-year Orphan Drug Exclusivity, the risk that commercial launch of FT218 (if approved) is delayed, the risk that the potential market performance for FT218 (if approved) may differ materially from projections, and the risk that the impact of the current COVID-19 pandemic on our financial results and results of operations could be greater than we anticipate and the risks and uncertainties described in the “Risk Factors” section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019, which we filed with the Securities and Exchange Commission (SEC) on March 16, 2020 and subsequent SEC filings.
Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.
Contacts:
Investor Contacts
Tom McHugh
Chief Financial Officer
Phone: (636) 449-1843
Email: tmchugh@avadel.com
Tim McCarthy
LifeSci Advisors, LLC
Phone: (212) 915.2564
Email: tim@lifesciadvisors.com
Media Contact
Patrick Bursey
LifeSci Communications, LLC
Phone: (646) 970-4688
Email: pbursey@lifescicomms.com