ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
applicable | ||
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
Title of each class |
Trading Symbol |
Name of each exchange on which registered | ||
☒ | Accelerated filer | ☐ | ||||
Non-accelerated filer |
☐ | Smaller reporting company | ||||
Emerging growth company |
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52 |
Item 10. |
Directors, Executive Officers and Corporate Governance |
Director Name and Year First Became a Director |
Age |
Position(s) with the Company | ||
Lars G. Ekman, M.D., Ph.D. (2008) |
72 | Director | ||
Jan van Heek (2010) |
72 | Director | ||
Karim Mikhail (2021) |
51 | President, Chief Executive Officer, Director | ||
Patrick J. O’Sullivan (2011) |
80 | Director | ||
Per Wold-Olsen (2022) |
74 | Director | ||
Kristine Peterson (2010) |
62 | Director | ||
David Stack (2012) |
71 | Director | ||
Joseph S. Zakrzewski (2010) |
59 | Director |
Name |
Age |
Position | ||
Executive Officers |
||||
Karim Mikhail (1) |
51 | President and Chief Executive Officer (principal executive officer) | ||
Steven B. Ketchum, Ph.D. |
57 | President of Research and Development, Senior Vice President and Chief Scientific Officer | ||
Michael W. Kalb |
51 | Senior Vice President and Chief Financial Officer, Assistant Secretary (principal financial officer and principal accounting officer) | ||
Aaron D. Berg |
59 | Executive Vice President, President-US | ||
Jason Marks |
46 | Executive Vice President, Global Chief Legal Officer and Corporate Secretary |
(1) | Karim Mikhail is also a member of our Board, and his biographical information appears under “— Directors |
Item 11. |
Executive Compensation |
Karim Mikhail | President and Chief Executive Officer | |
Steven B. Ketchum, Ph.D. | President of Research and Development, Executive Vice President and Chief Scientific Officer | |
Michael W. Kalb | Senior Vice President and Chief Financial Officer, Assistant Secretary | |
Aaron D. Berg | Executive Vice President and President, U.S. | |
Jason M. Marks | Executive Vice President, Chief Legal and Compliance Officer and Corporate Secretary | |
John F. Thero | Former President and Chief Executive Officer (retired effective August 1, 2021) | |
Joseph T. Kennedy | Former Executive Vice President, General Counsel and Strategic Initiatives, Corporate Secretary (retired effective August 1, 2021) |
• | U.S. net product revenue was $577.9 million for the year ended December 31,2021 amidst the ongoing challenges of the COVID-19 pandemic and the impact of additional generic icosapent ethyl market entrants |
• | U.S. commercial operations remain positive supporting our investments to expand into Europe |
• | The launch of the Go-To-Market |
• | Expanding provider engagement |
• | Enhanced awareness and use of VASCEPA with optimized sales force and expanded reach to approximately 150,000 healthcare providers |
• | Continued evaluation of resources and encouraging pay-for-performance |
• | Focusing on managed care access |
• | In December 2021, Amarin had approximately 40% of total commercial and Medicare Part D lives on a weighted average basis with VASCEPA as the exclusive IP product, and additional anticipated decisions could positively impact our exclusive coverage level in 2022 beyond 40% |
• | Improved access for VASCEPA for 25% of all commercial lives |
• | Optimizing fulfillment of VASCEPA prescriptions for cardiovascular (“CV”) risk reduction |
• | Launched new VASCEPA campaign focused on prior myocardial infarction and stroke patients at a heightened risk of a subsequent event to generate immediate growth acceleration |
• | Partnered with BlinkRx to support fulfillment process across the continuum of care, to ensure patients can start and remain on VASCEPA |
• | Received market approval of VAZKEPA by the European Commission and the UK Medicines and Healthcare products regulatory agency (“MHRA”) as the first and only treatment to reduced CV risk in high-risk, statin-treated adult patients who have elevated triglycerides (≥150 mg/dL) and other risk characteristics |
• | Submitted market access and reimbursement dossiers in ten European countries (namely Germany, UK, Italy, France, Spain, Denmark, Sweden, Finland, Norway, and the Netherlands) ahead of plan |
• | Clinical and Health Technology Assessments processes and reimbursement discussions progressed in all targeted markets |
• | Launched VAZKEPA in Germany despite resurging COVID-19 disruptions. Progressed commercial launch plans of VAZKEPA in up to six countries as expected, with preparations underway in several key markets |
• | Actively negotiated partnerships to bring VAZKEPA to Central and Eastern European markets via marketing and distribution agreements with partners who have established infrastructure in such markets |
• | Expects regulatory filings, approvals and potential launches of VASCEPA, via partners, in up to six new countries, including Australia, New Zealand, and certain Asia-Pacific markets in 2022 |
• | Received acceptances of VASCEPA for regulatory review in Australia and Israel, and have embarked on initiatives to engage a commercial partner to market/distribute VASCEPA in this region |
• | The National Medical Products Administration (“NMPA”) accepted for review the new drug application for VASCEPA submitted by Edding, Amarin’s partner in China |
• | Expects final decisions from the NMPA in mainland China and from the regulatory authority in Hong Kong in the second half of 2022 |
• | Expanded VASCEPA commercialization in several Middle Eastern countries, including Lebanon, United Arab Emirates, and Qatar through partners |
• | Continued execution of international expansion strategy that features plans to bring the CV reduction benefits of VASCEPA/VAZKEPA to approximately 20 additional countries over the course of the next three years through a series of distribution agreements and partnerships |
• | Amarin’s partner in Canada, HLS Therapeutics, announced a co-promotional agreement for VASCEPA with Pfizer in Canada |
• | provide a competitive total compensation package that enables the Company to attract and retain highly qualified executives with the skills and experience required for the achievement of business goals; |
• | align compensation elements with the Company’s annual goals and long-term business strategies and objectives; |
• | promote the achievement of key strategic and financial performance measures by linking short-term and long-term cash and equity incentives to the achievement of measurable corporate and individual performance goals; and |
• | align executives’ incentives with the creation of shareholder value. |
Company/Market/Peer Company |
12/31/2017 |
12/31/2018 |
12/31/2019 |
12/31/2020 |
12/31/2021 |
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Amarin Corporation PLC |
$ | 130.19 | $ | 429.87 | $ | 699.68 | $ | 162.66 | $ | 109.42 | ||||||||||
NASDAQ Composite Index |
$ | 128.24 | $ | 122.32 | $ | 167.31 | $ | 237.87 | $ | 290.63 | ||||||||||
NASDAQ Biotechnology Index |
$ | 121.06 | $ | 107.67 | $ | 137.61 | $ | 176.79 | $ | 170.55 |
• | the Company’s use of different types of compensation vehicles to provide a balance of long- and short-term incentives with fixed and variable components; |
• | the granting of equity-based awards with time-based vesting and performance-based vesting, both of which encourage participants to work towards long-term appreciation in equity values; |
• | the Company’s annual bonus determinations for each employee and vesting of performance-based equity awards being tied to achievement of Company goals, which goals promote long-term value; and |
• | the Company’s system of internal control over financial reporting and Code of Business Conduct and Ethics, which among other things, reduce the likelihood of manipulation of the Company’s financial performance to enhance payments under any of its incentive plans. |
• | in 2017 and early 2018, executive officers of the Company were granted performance-based restricted stock units which were earned if the Company’s REDUCE-IT cardiovascular outcomes study was deemed to be successful and only if product revenue reaches pre-defined annual milestone levels ranging from $300 million to $500 million and then vest only if the recipient remains with the Company for an extended period of time following completion of the REDUCE-IT study; |
• | in 2019, certain executive officers and other senior management of the Company were granted performance-based restricted stock units which are earned only if the Company’s aggregate revenue reaches a pre-defined annual milestone level of $1.0 billion; |
• | in 2020, certain executive officers and other senior management of the Company were granted performance-based restricted stock units which are earned only if the Company’s aggregate revenue reaches pre-defined annual milestone levels of $1.25 billion (in which case 50% of the award will vest) or $1.50 billion (in which case 100% of the award will vest) while others in senior management were granted performance-based restricted stock units, prior to VAZKEPA approval in Europe and prior to securing market access in Europe, based on rapidly achieving net revenue levels in Europe of at least $125 million (in which case 50% of the award will vest) or $250 million (in which case 100% of the award will vest); and |
• | in 2021, certain executive officers and other senior management of the Company were granted performance-based restricted stock units which are earned only: |
• | with respect to U.S. centric employees, (x) if the Company’s U.S. net revenues in 2021 or any calendar year thereafter reaches $1 billion or (y) if the market share for icosapent ethyl exceeds 50% in 2022 or any calendar year thereafter or (z) if the Company achieves greater than $200 million in annual U.S. operating income in 2022 or any calendar year thereafter (the “U.S. Goals”); |
• | with respect to European-centric employees, (x) as to 50% if the Company achieves at least $300 million in European net revenue in 2021 or any calendar year thereafter and (y) as to 50% if the Company achieves greater than $50 million in annual European operating income in 2021 or any calendar year thereafter (the “European Goals”); and |
• | for global-sales centric employees, as to 25% of such award, upon the Company’s achievement of each U.S. Goal and/or the European Goal. |
ACADIA Pharmaceuticals | Halozyme Therapeutics* | Pacira Biosciences* | ||
Akcea Therapeutics* | Intercept Pharmaceuticals* | PTC Therapeutics* | ||
Akebia Therapeutics | Ionis Pharmaceuticals* | Repligen Corporation* | ||
Alkermes* | Ironwood Pharmaceuticals* | Supernus Pharmaceuticals* | ||
Emergent BioSolutions | Jazz Pharmaceuticals* | United Therapeutics | ||
Exelixis* | Neurocrine Biosciences* |
* | Included in prior-year peer group. |
• | Base Salary |
• | Annual Incentive Bonus |
• | Equity Compensation (subject to time and/or performance vesting) |
• | Employee Benefit Programs |
• | individual performance of the executive, as well as overall performance of the Company, during the prior year; |
• | level of responsibility, including breadth, scope and complexity of the position; |
• | level of experience and expertise of the executive; |
• | internal review of the executive’s compensation relative to other executives to ensure internal equity; |
• | level of the executive’s compensation in the form of equity incentive awards; and |
• | executive officer compensation levels at other similar companies to ensure competitiveness. |
(i) | increase management focus on goals that are challenging but achievable and intended to create value for shareholders; |
(ii) | encourage management to work as a team to achieve the Company’s goals; |
(iii) | encourage individuals to realize goals that are meaningful to the Company; |
(iv) | provide incentives for management to strive for achievement above and beyond the Company goals; and |
(v) | help attract and retain high quality senior management personnel. |
• | Improve profit from U.S. commercial activities to exceed $200 million** (80%) |
• | Compliance: Favorable year-end report to our Board on adherence to, and compliance with, corporate compliance program and no lost claim due to untruthful or misleading statements to healthcare professionals (20%) |
* | Certain of the metrics under the MICP tied to the 2021 operating plan above and throughout this Amendment include highly sensitive data, including international expansion projections, inventory purchase requirements, cash outflows and support for supplier capacity expansion. We do not disclose the specific target levels for these metrics, including as they inform certain individual performance goals, because we believe that such disclosure would result in competitive harm to our Company. We purposely set these target levels at aggressive levels. Revealing these metrics, including the reasoning for setting targets at specific levels, could potentially reveal insights about our commercialization plans and research and other objectives that our competitors could use against us in the marketplace for similar pharmaceutical products. We believe each of these target levels was designed to be challenging but attainable under assumed conditions if we had what we considered to be a successful year. |
** | In 2021, the Company utilized a profitability metric rather than a revenue-based performance metric to further encourage top-line growth and administrative efficiencies. The profitability figure above refers to U.S. gross margin minus U.S. sales and marketing related expenses. |
• | Secure approval of marketing authorization (“MAA”) for CV risk reduction by the end of the first quarter of 2021 (25%) |
• | Launch commercially in Germany in the third quarter of 2021 (50%) |
• | Secure market access with pricing consistent with the Company’s plan in at least one country (25%) |
• | China |
• | China REDUCE-IT results (25%) |
• | Canada and the Middle East and North Africa |
• | Secure an in-license for development of (or develop organically) a new product or a new indication capable of supporting at least a specified amount in peak sales and advance such opportunity to status of clinically viable with business plan supported by our Board (75%) |
• | Complete ongoing COVID-19 studies (25%) |
• | Supply price |
• | Suppliers on-line (or schedule to be on-line) to meet or exceed a specified percentage of base case revenue scenarios for 2022 and 2023 as determined for next year’s plan (50%) |
• | Cash outflow from operations |
• | the U.S. Commercial Profitability Improvement goal was achieved at the 100% level, resulting in a weighted score of 20% for this component of the corporate goals; |
• | the European Commercialization goal was achieved at the 100% level, resulting in a weighted score of 20% for this component of the corporate goals; |
• | the International Expansion goal was achieved at the 75% level, resulting in a weighted score of 7.5% for this component of the corporate goals; |
• | the R&D/Business Development goal was achieved at the 25% level, resulting in a weighted score of 5% for this component of the corporate goals; |
• | the Supply goal was achieved at the 100% level, resulting in a weighted score of 20% for this component of the corporate goals; and |
• | the Financial goal was achieved at the 100% level, resulting in a weighted score of 10% for this component of the corporate goals. |
• | Secure first-cycle positive opinion on EU MAA from the European Medicines Agency (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) and European Commission approval |
• | Support commercial launch in Germany |
• | Leverage “Reliance Route” to submit UK MAA within one month of CHMP positive opinion; secure first-cycle approval of UK MAA for CV risk reduction by the end of 2021 and support product launch in UK per the Company’s plan |
• | Incorporate Swissmedic pre-submission feedback into final dossier and submit Swiss MAA |
• | Determine and implement short-and long-term strategies for meeting country-specific Responsible Person requirements per the Company’s plan |
• | Submit variations to add certain drug substance suppliers and secure EU approval by end of 2021 |
• | Successfully complete required process validation lots to enable EU launch |
• | Qualify EU-based packaging facility and submit variation to MAA per the Company’s plan |
• | Support existing ex-US partnerships and future potential partnering activities throughout 2021 |
• | Ensure product quality and uninterrupted supplies that meet near-term and future commercial demands and research needs throughout 2021 |
• | Continue data flow for REDUCE-IT throughout 2021 |
• | In-license for development (or develop organically) a new product or a new indication capable of supporting a specified amount in peak sales and advance such opportunity to status of clinically viable with business plan supported by the Board and execute per the Company’s plan |
• | Support completion of ongoing COVID-19 studies and help create recommended next steps for presentation to the Board by the end of 2021 |
• | Submit pre-investigation new drug rationale for a proscribed indication pursuant the Company’s plan |
• | Ensure gross cash outflow is not greater than the Company’s 2021 operating plan (except if supported by higher than plan revenues) |
• | Manage cash balance and net operating cash flow such that it is equal to or greater than the Company’s 2021 operating plan: create and implement quarterly internal risk/return analysis in compliance with investment policy and improve cash inflow/outflow analysis with quarterly explanations of any major plan variances leading to improved cash forecasting to satisfaction of the Chief Executive Officer |
• | Improve processes by which 2021 and 2022 financial assumptions are updated on a rolling basis and goal performance are reviewed quarterly with department and functional leads to enhance 2021 accountability and to ensure alignment/identify changes; present significant assumption changes to the Chief Executive Officer on a timely basis as warranted; launch formal operating plan kickoff approximately one week following the Company’s strategic meeting and complete the operating plan, including certain goals, at least one week before December Board meeting |
• | Maintain operational expenses for Finance/Accounting and Investor Relations which do not exceed the Company’s 2021 operating plan |
• | Implement efficiencies relating to auditor, press release and website matters related to quarterly and annual reporting |
• | Ensure no material control weaknesses from 2021 compliance testing or from 2020 compliance testing completed in 2021 |
• | Update policies and procedures to ensure adequacy of infrastructure in Europe to ensure timely reporting (including statutory reporting), tax compliance and value-added tax compliance |
• | Work with accountants and advisors to establish internal controls over financial reporting throughout Europe by the end of the second quarter of 2021 |
• | Continue creation and implementation of EU corporate structure with Legal, including maintaining consistency with current corporate structure; update transfer pricing study for current structure |
• | Work with U.S. commercial team to proactively address and respond to market dynamics (e.g., COVID-19 and generic entry) to ensure achievement of target U.S. commercial operating income |
• | Build the necessary European financial infrastructure to ensure timely and accurate financial closes and reporting |
• | In conjunction with the business development team, support the evaluation of potential transactions per the Company’s plan, including providing and updating corporate forecasts as applicable and providing other financial support |
• | Coordinate U.S. website refresh to be live by February 2021, ensure it is perpetually updated and ensure that potential increase in activity from EU investors is addressed consistent with peer company standards |
• | Assist Investor Relations with responsiveness to investor inquiries |
• | Draft press releases, to the extent possible, at least one week prior to target release dates |
• | Improve profit from U.S. commercial activities per the Company’s plan |
• | Favorable year-end report to the Board on adherence to and compliance with corporate compliance program and no lost claim due to untruthful or misleading statements to healthcare professionals |
• | Conduct comprehensive analysis of COVID-19/generic launch impact and recommend prudent optimization strategy; subject to Board approval, implement in the second quarter of 2021 and achieve strategic triggers |
• | Increase sales professionals’ cost-effective productivity as per 2021 operation plan |
• | Increase sales reach and productivity of target as per the Company’s 2021 operating plan |
• | Before the end of the first quarter of 2021, create and implement strategies and tactics to increase awareness of the need for preventative CV care as patients returning to routine medical care and achieve objectives established in such plans |
• | Increase formulary access for covered lives in accordance with the Company’s 2021 operating plan |
• | grants made in conjunction with the hiring of a new employee or the promotion of an existing employee will generally be made at meetings of the Remuneration Committee, and effective on the first trading day of the month following the later of (1) the hire date or the promotion date or (2) the date on which such grant is approved; and |
• | grants made to existing employees other than in connection with a promotion will be made, if at all, on an annual basis and generally shall be made effective on the first trading day of the month following the date on which such grant is approved. |
Position |
Target | |
Chief Executive Officer | 3x annual base salary | |
Other Executive Officers | 1x annual base salary |
Name and Principal Position |
Fiscal Year |
Salary ($) |
Bonus ($) (2) |
Stock Awards ($) (3) |
Option Awards ($) (4) |
Non-Equity Incentive Plan Compensation ($) (5) |
All Other Compensation ($) (6) |
Total ($) |
||||||||||||||||||||||||
Karim Mikhail |
2021 | 672,747 | 50,000 | 3,099,291 | 1,546,456 | 430,000 | 36,059 | 5,834,553 | ||||||||||||||||||||||||
President and Chief Executive Officer (1) |
||||||||||||||||||||||||||||||||
Steven B. Ketchum, Ph.D. |
2021 | 562,608 | — | 1,462,784 | 1,084,166 | 258,000 | 7,012 | 3,374,570 | ||||||||||||||||||||||||
President of Research and Development, Senior Vice President and Chief Scientific Officer |
2020 | 525,975 | — | 2,396,186 | 1,283,786 | 225,250 | 6,912 | 4,438,109 | ||||||||||||||||||||||||
2019 | 480,083 | — | 1,487,934 | 697,694 | 350,905 | 6,712 | 3,023,328 | |||||||||||||||||||||||||
Michael W. Kalb |
2021 | 473,933 | — | 1,765,147 | 765,949 | 204,930 | 7,012 | 3,216,971 | ||||||||||||||||||||||||
Senior Vice President and Chief Financial Officer, Assistant Secretary |
2020 | 458,275 | — | 2,396,186 | 1,283,786 | 191,475 | 6,912 | 4,336,634 | ||||||||||||||||||||||||
2019 | 438,058 | — | 1,487,934 | 697,694 | 227,832 | 6,712 | 2,858,230 | |||||||||||||||||||||||||
Aaron D. Berg |
2021 | 505,100 | — | 1,462,781 | 1,084,166 | 233,406 | 7,012 | 3,292,468 | ||||||||||||||||||||||||
Senior Vice President and Chief Commercial Officer |
2020 | 458,275 | — | 2,396,186 | 1,283,786 | 190,900 | 6,912 | 4,336,059 | ||||||||||||||||||||||||
2019 | 438,058 | — | 1,487,934 | 697,694 | 228,820 | 6,712 | 2,859,218 | |||||||||||||||||||||||||
Jason Marks |
2021 | 173,766 | 207,219 | 1,086,000 | 423,522 | — | 1,811 | 1,892,318 | ||||||||||||||||||||||||
Executive Vice President and Global Chief Legal Officer and Corporate Secretary (7) |
||||||||||||||||||||||||||||||||
John F. Thero |
2021 | 670,923 | — | 5,353,429 | 3,067,754 | 536,738 | 6,810 | 9,635,654 | ||||||||||||||||||||||||
Former President and Chief Executive Officer (8) |
2020 | 810,000 | — | 11,882,188 | 4,665,531 | 551,040 | 6,912 | 17,915,671 | ||||||||||||||||||||||||
2019 | 697,067 | — | 3,645,607 | 3,944,907 | 635,250 | 6,712 | 8,929,543 | |||||||||||||||||||||||||
Joseph T. Kennedy |
2021 | 443,645 | — | 1,160,421 | 765,949 | 216,824 | 6,503 | 2,593,342 | ||||||||||||||||||||||||
Former Executive Vice President, General Counsel and Strategic Initiatives, Secretary (9) |
2020 | 525,975 | — | 2,396,186 | 1,283,786 | 229,888 | 6,912 | 4,442,747 | ||||||||||||||||||||||||
2019 | 480,083 | 60,000 | 1,487,934 | 697,694 | 250,905 | 6,712 | 2,983,328 |
(1) | Mr. Mikhail was promoted to, and began serving as, our President and Chief Executive Officer in August 2021, and did not serve as our executive officer during fiscal years 2020 and 2019. Accordingly, his compensation with respect to fiscal years 2020 and 2019 are not included. In addition to serving as our President and Chief Executive Officer, Mr. Mikhail serves as a member of our board of directors, but receives no additional compensation for his service in such role. |
(2) | The amounts reported in the “Bonus” column for 2021 and 2019 for Mr. Mikhail and Mr. Kennedy, respectively, consist of discretionary cash bonuses awarded under the MICP for significant achievements during 2021 and exceptional performance in 2019, respectively. The amount reported in the “Bonus” column for 2021 for Mr. Marks consists of the bonus agreed upon in his employment agreement with the Company that he entered into when he joined the Company in August 2021. |
(3) | This column reflects the aggregate grant date fair value of time- and performance-based vesting restricted stock unit awards granted in each year calculated in accordance with FASB ASC 718, excluding the effect of estimated forfeitures related to service-based vesting. For performance-based restricted stock units, the value reported reflects the value of the award at the grant date based upon the probable outcome of the performance conditions. For the performance-based restricted stock units granted in 2021, the grant date fair value of each such award included in the table assuming the probable outcome of the performance conditions (which is assumed to be the maximum level of achievement) is $1,671,000 for Mr. Mikhail, $439,622 for each of Dr. Ketchum, Mr. Kalb, Mr. Berg and Mr. Kennedy, $543,000 for Mr. Marks and $2,465,706 for Mr. Thero. For the performance-based restricted stock units granted in 2020, the grant date fair value of each such award included in the table assuming the probable outcome of the performance conditions (which is assumed to be the maximum level of achievement) is $9,014,778 for Mr. Thero and $1,607,286 for each of Dr. Ketchum, Mr. Kalb, Mr. Berg and Mr. Kennedy. For the performance-based restricted stock units granted in 2019, the grant date fair value of each such award included in the table assuming the probable outcome of the performance conditions (which is assumed to be the maximum level of achievement) is $843,500 for each of Dr. Ketchum, Mr. Kalb, Mr. Berg and Mr. Kennedy. Assumptions used in the calculations for these amounts are set forth in Note 11 to our consolidated financial statements included in the Original Form 10-K Filing. |
(4) | This column reflects the aggregate grant date fair value of time-based stock option awards granted in each year and calculated in accordance with FASB ASC 718, excluding the effect of estimated forfeitures. Assumptions used in the calculations for these amounts are set forth in Note 11 to our consolidated financial statements included in the Original Form 10-K Filing. |
(5) | This column reflects payments made under the MICP and special incentive bonus programs in respect of the year earned. See the discussion regarding annual and special incentive compensation in “ Executive Compensation Discussion and Analysis |
(6) | The amounts included in this column represent company-paid match of 401(k)/pension contributions and life insurance premiums. |
(7) | Mr. Marks joined the Company in August 2021 as the Company’s Senior Vice President, Chief Legal Officer and Corporate Secretary and was promoted to Executive Vice President and Global Chief Legal Officer in April 2022. |
(8) | Mr. Thero resigned as President and Chief Executive Officer, and a member of the board of directors, of the Company, effective August 1, 2021, and provided transitional services through October 31, 2021. Mr. Thero received no additional compensation for his service as a member of our board of directors. |
(9) | Mr. Kennedy resigned as Executive Vice President, General Counsel and Strategic Initiatives and Secretary of the Company, effective August 1, 2021, and provided transitional services through October 31, 2021. |
Name |
Grant Date |
All Other Option Awards: Number of Securities Underlying Options (#) |
Exercise or Base Price of Option Awards ($/Sh) |
Grant Date Fair Value of Option Awards ($) (1) |
||||||||||||
Karim Mikhail |
|
1/4/2021 4/12/2021 |
|
|
46,000 290,200 |
(2) (2) |
|
5.03 4.97 |
|
|
182,086 1,364,370 |
| ||||
Steven B. Ketchum, Ph.D. |
|
1/4/2021 8/2/2021 |
|
|
193,500 96,750 |
(2) (2) |
|
5.03 4.22 |
|
|
765,949 318,217 |
| ||||
Michael W. Kalb |
1/4/2021 | 193,500 | (2) |
5.03 | 765,949 | |||||||||||
Aaron D. Berg |
|
1/4/2021 8/2/2021 |
|
|
193,500 96,750 |
(2) (2) |
|
5.03 4.22 |
|
|
765,949 318,217 |
| ||||
Jason Marks |
9/1/2021 | 100,000 | (3) |
5.43 | 423,522 | |||||||||||
John F. Thero |
1/4/2021 | 775,000 | (2) |
5.03 | 3,067,754 | |||||||||||
Joseph T. Kennedy |
1/4/2021 | 193,500 | (2) |
5.03 | 765,949 |
(1) | This column reflects the aggregate grant date fair value of option awards granted in 2021, and is calculated in accordance with FASB ASC 718, using the Black-Scholes option-pricing model, excluding the effect of estimated forfeitures. Assumptions used in the calculations for these amounts are set forth in Note 11 to our consolidated financial statements included in the Original Form 10-K Filing. |
(2) | These options vest over four years, with 25% vesting on the first anniversary of the grant date and the balance vesting ratably over the subsequent 12 calendar quarters. |
(3) | These options vest over four years, with 25% vesting on August 19, 2022 and the balance vesting ratably over the subsequent 12 calendar quarters. |
Name |
Grant Date |
All Other Stock Awards: Number of Shares of Stock or Units (#) |
Grant Date Fair Value of Stock Awards ($) (1) |
|||||||||
Karim Mikhail |
|
1/4/2021 4/12/2021 |
|
|
34,100 215,200 |
(2) (3) |
|
171,523 1,256,768 |
| |||
Steven B. Ketchum, Ph.D. |
|
1/4/2021 8/2/2021 |
|
|
143,300 71,650 |
(2) (4) |
|
720,799 302,363 |
| |||
Michael W. Kalb |
|
1/4/2021 8/2/2021 |
|
|
143,300 143,300 |
(2) (4) |
|
720,799 604,726 |
| |||
Aaron D. Berg |
|
1/4/2021 8/2/2021 |
|
|
143,300 71,650 |
(2) (4) |
|
720,799 302,363 |
| |||
Jason Marks |
9/1/2021 | 100,000 | (5) |
543,000 | ||||||||
John F. Thero |
1/4/2021 | 574,100 | (2) |
2,887,723 | ||||||||
Joseph T. Kennedy |
1/4/2021 | 143,300 | (2) |
720,799 |
(1) | This column reflects the aggregate grant date fair value of time-based restricted stock unit awards granted in 2021, calculated in accordance with FASB ASC 718, excluding the effect of estimated forfeitures. Assumptions used in the calculations for these amounts are set forth in Note 11 to our consolidated financial statements included in the Original Form 10-K Filing. |
(2) | These restricted stock unit awards vest in three equal annual installments on each of December 31, 2021, December 31, 2022 and December 31, 2023. |
(3) | These restricted stock unit awards vest in three equal annual installments on each of April 12, 2022, April 12, 2023 and April 12, 2024. |
(4) | These restricted stock unit awards vest in three equal annual installments on each of July 31, 2022, July 31, 2023 and July 31, 2024. |
(5) | These restricted stock unit awards vest in three equal annual installments on each of August 19, 2022, August 19, 2023 and August 19, 2024. |
Estimated Future Payouts Under Equity Incentive Plan Awards |
||||||||||||
Name |
Grant Date |
Target (#) (1) |
Grant Date Fair Value of Stock Awards ($) (2) |
|||||||||
Karim Mikhail |
|
1/4/2021 4/12/2021 |
|
|
100,000 200,000 |
(3) |
|
503,000 1,168,000 |
| |||
Steven B. Ketchum, Ph.D. |
1/4/2021 | 87,400 | (3) |
439,622 | ||||||||
Michael W. Kalb |
1/4/2021 | 87,400 | (3) |
439,622 | ||||||||
Aaron D. Berg |
1/4/2021 | 87,400 | (3) |
439,622 | ||||||||
Jason Marks |
9/1/2021 | 100,000 | (3) |
543,000 | ||||||||
John F. Thero |
1/4/2021 | 490,200 | (3) |
2,465,706 | ||||||||
Joseph T. Kennedy |
1/4/2021 | 87,400 | (3) |
439,622 |
(1) | There is no threshold for these awards and the target equates to the maximum. |
(2) | This column reflects the aggregate grant date fair value, calculated in accordance with FASB ASC 718 assuming the probable outcome of the performance condition on the grant date, which was assumed to be maximum achievement of such condition. |
(3) | This amount represents restricted stock unit awards that vest and are earned only if pre-defined sales and operational milestones are achieved by December 31, 2027. To date, the pre-defined sales and operational milestones have not been achieved and, as a result, none of the restricted stock units have vested. |
Estimated Future Payouts Under Non-Equity Incentive PlanAwards ($) |
||||||||||||
Name |
Grant Date |
Target(1) |
Maximum(1) |
|||||||||
Karim Mikhail |
— | 525,000 | (1) |
525,000 | (1) | |||||||
Steven B. Ketchum, Ph.D. |
— | 300,000 | (1) |
300,000 | (1) | |||||||
Michael W. Kalb |
— | 237,600 | (1) |
237,600 | (1) | |||||||
Aaron D. Berg |
— | 275,000 | (1) |
275,000 | (1) | |||||||
Jason Marks |
— | 87,466 | (2) |
87,466 | (2) | |||||||
John F. Thero |
— | 675,680 | (3) |
675,680 | (3) | |||||||
Joseph T. Kennedy |
— | 272,950 | (3) |
272,950 | (3) |
(1) | The amounts in the “Target” and “Maximum” columns reflect the potential payouts under the 2021 MICP. The amounts in the “Maximum” column represent the amounts that could be earned if all corporate performance, |
individual performance and pre-defined stretch goals under the 2021 MICP are achieved. Actual bonuses awarded to the individuals were based on achievement of objectives, as discussed in the “Executive Compensation Discussion and Analysis |
(2) | Represents potential payouts under the 2021 MICP as described in (1) above, pro-rated for the amount of time he was an employee in 2021. |
(3) | Represents potential payouts under the 2021 MICP as described in (1) above. Pursuant to and conditioned upon compliance with Mr. Thero’s and Mr. Kennedy’s separation agreements, each of Mr. Thero’s and Mr. Kennedy’s actual bonus was calculated on a pro-rata basis based on their 2021 service. |
Option Awards |
Stock Awards |
|||||||||||||||
Name |
Number of Shares Acquired on Exercise (#) |
Value Realized on Exercise ($) |
Number of Shares Acquired on Vesting (#) |
Value Realized on Vesting ($) |
||||||||||||
Karim Mikhail |
— | — | 44,701 | 184,082 | ||||||||||||
Steven B. Ketchum, Ph.D. |
470,595 | 2,528,885 | 237,276 | 1,456,803 | ||||||||||||
Michael W. Kalb |
120,000 | 348,440 | 237,276 | 1,456,803 | ||||||||||||
Aaron D. Berg |
— | — | 237,276 | 1,394,143 | ||||||||||||
Jason Marks |
— | — | — | — | ||||||||||||
John F. Thero |
— | — | 1,039,209 | 6,460,352 | ||||||||||||
Joseph T. Kennedy |
— | — | 261,718 | 1,619,740 |
Number of Securities Underlying Unexercised Options |
Option Exercise Price ($/Sh) |
Option Expiration Date |
||||||||||||||
Name |
Exercisable (#) |
Unexercisable (#) |
||||||||||||||
Karim Mikhail |
31,250 | 68,750 | (1) |
7.03 | 7/1/2030 | |||||||||||
— | 46,000 | (2) |
5.03 | 1/4/2031 | ||||||||||||
— | 290,200 | (3) |
4.97 | 4/12/2031 | ||||||||||||
Steven B. Ketchum, Ph.D. |
29,250 | 2,437 | (4) |
3.80 | 2/1/2028 | |||||||||||
36,782 | 16,718 | (5) |
16.87 | 2/1/2029 | ||||||||||||
42,219 | 54,281 | (6) |
18.39 | 2/3/2030 | ||||||||||||
— | 193,500 | (2) |
5.03 | 1/4/2031 | ||||||||||||
— | 96,750 | (7) |
4.22 | 8/2/2031 | ||||||||||||
Michael W. Kalb |
55,000 | — | 2.19 | 7/1/2026 | ||||||||||||
39,000 | — | 2.95 | 2/1/2027 | |||||||||||||
83,563 | 2,437 | (4) |
3.80 | 2/1/2028 | ||||||||||||
36,782 | 16,718 | (5) |
16.87 | 2/1/2029 | ||||||||||||
42,219 | 54,281 | (6) |
18.39 | 2/3/2030 |
Number of Securities Underlying Unexercised Options |
Option Exercise Price ($/Sh) |
Option Expiration Date |
||||||||||||||
Name |
Exercisable (#) |
Unexercisable (#) |
||||||||||||||
— | 193,500 | (2) |
5.03 | 1/4/2031 | ||||||||||||
Aaron D. Berg |
3,906 | — | 1.02 | 2/2/2025 | ||||||||||||
49,998 | — | 2.50 | 7/6/2025 | |||||||||||||
36,458 | — | 1.40 | 2/1/2026 | |||||||||||||
69,270 | — | 2.95 | 2/1/2027 | |||||||||||||
75,555 | 12,185 | 2.80 | 5/1/2028 | |||||||||||||
36,782 | 16,718 | (5) |
16.87 | 2/1/2029 | ||||||||||||
42,219 | 54,281 | (6) |
18.39 | 2/3/2030 | ||||||||||||
— | 193,500 | (2) |
5.03 | 1/4/2031 | ||||||||||||
— | 96,750 | (7) |
4.22 | 8/2/2031 | ||||||||||||
Jason Marks |
— | 100,000 | (8) |
5.43 | 9/1/2031 | |||||||||||
John F. Thero (9) |
83,230 | — | 8.86 | 2/1/2022 | ||||||||||||
52,500 | — | 8.10 | 1/2/2023 | |||||||||||||
558,475 | — | 2.04 | 1/8/2024 | |||||||||||||
293,628 | — | 1.02 | 2/2/2025 | |||||||||||||
600,000 | — | 2.50 | 7/6/2025 | |||||||||||||
400,000 | — | 2.50 | 7/6/2025 | |||||||||||||
363,400 | — | 2.50 | 7/6/2025 | |||||||||||||
550,000 | — | 1.40 | 2/1/2026 | |||||||||||||
550,000 | — | 2.95 | 2/1/2027 | |||||||||||||
546,375 | 11,625 | (4) |
3.80 | 2/1/2028 | ||||||||||||
207,969 | 94,531 | (5) |
16.87 | 2/1/2029 | ||||||||||||
153,432 | 197,268 | (6) |
18.39 | 2/3/2030 | ||||||||||||
— | 775,000 | (2) |
5.03 | 1/4/2031 | ||||||||||||
Joseph T. Kennedy (10) |
18,228 | — | 1.40 | 2/1/2026 | ||||||||||||
65,310 | — | 2.95 | 2/1/2027 | |||||||||||||
73,123 | 2,437 | (4) |
3.80 | 2/1/2028 | ||||||||||||
36,782 | 16,718 | (5) |
16.87 | 2/1/2029 | ||||||||||||
42,219 | 54,281 | (6) |
18.39 | 2/3/2030 | ||||||||||||
— | 193,500 | (2) |
5.03 | 1/4/2031 |
(1) | Twenty-five percent (25%) of the shares underlying this stock option vested on July 1, 2021, and the remaining 75% of the shares underlying this option vest ratably over the next 12 quarters. |
(2) | Twenty-five percent (25%) of the shares underlying this stock option vested on January 4, 2022, and the remaining 75% of the shares underlying this option vest ratably over the next 12 quarters. |
(3) | Twenty-five percent (25%) of the shares underlying this stock option vested on April 12, 2022, and the remaining 75% of the shares underlying this option vest ratably over the next 12 quarters. |
(4) | The shares underlying these stock options vest monthly over 48 months beginning February 28, 2018. |
(5) | The shares underlying these stock options vest quarterly over 16 quarters beginning May 15, 2019. |
(6) | The shares underlying these stock options vest quarterly over 16 quarters beginning April 30, 2020. |
(7) | Twenty-five percent (25%) of the shares underlying this stock option vest on August 2, 2022, and the remaining 75% of the shares underlying this option vest ratably over the next 12 quarters. |
(8) | Twenty-five percent (25%) of the shares underlying this stock option vest on August 19, 2022, and the remaining 75% of the shares underlying this option vest ratably over the next 12 quarters. |
(9) | Mr. Thero’s stock options stopped vesting at the conclusion of his consultancy period with the Company on February 28, 2022. |
(10) | Mr. Kennedy’s stock options stopped vesting at the conclusion of his consultancy period with the Company on March 31, 2022. |
Name |
Number of Shares or Units of Stock That Have Not Vested (#) |
Market Value of Shares or Units of Stock That Have Not Vested ($) (1) |
Equity Incentive Plan Awards: Number of Unearned Shares, Units or Other Rights That Have Not Vested (#) |
Equity Incentive Plan Awards: Market or Payout Value of Unearned Shares, Units or Other Rights That Have Not Vested ($) (1) |
||||||||||||
Karim Mikhail |
66,666 | (2) |
224,664 | — | — | |||||||||||
22,733 | (3) |
76,610 | — | — | ||||||||||||
215,200 | (4) |
725,224 | — | — | ||||||||||||
— | — | 100,000 | (5) |
337,000 | ||||||||||||
— | — | 100,000 | (5) |
337,000 | ||||||||||||
— | — | 200,000 | (5) |
674,000 | ||||||||||||
Steven B. Ketchum, Ph.D. |
12,733 | (6) |
42,910 | — | — | |||||||||||
32,666 | (7) |
110,084 | — | — | ||||||||||||
95,533 | (3) |
321,946 | — | — | ||||||||||||
71,650 | (8) |
241,461 | — | — | ||||||||||||
— | — | 50,000 | (5) |
168,500 | ||||||||||||
— | — | 87,400 | (5) |
294,538 | ||||||||||||
— | — | 87,400 | (5) |
294,538 | ||||||||||||
Michael W. Kalb |
12,733 | (5) |
42,910 | — | — | |||||||||||
32,666 | (6) |
110,084 | — | — | ||||||||||||
95,533 | (3) |
321,946 | — | — | ||||||||||||
143,300 | (8) |
482,921 | — | — | ||||||||||||
— | — | 50,000 | (5) |
168,500 | ||||||||||||
— | — | 87,400 | (5) |
294,538 | ||||||||||||
— | — | 87,400 | (5) |
294,538 | ||||||||||||
Aaron D. Berg |
12,733 | (5) |
42,910 | — | — | |||||||||||
32,666 | (6) |
110,084 | — | — | ||||||||||||
95,533 | (3) |
321,946 | — | — | ||||||||||||
71,650 | (8) |
241,461 | — | — | ||||||||||||
— | — | 50,000 | (5) |
168,500 | ||||||||||||
— | — | 87,400 | (5) |
294,538 | ||||||||||||
— | — | 87,400 | (5) |
294,538 | ||||||||||||
Jason Marks |
100,000 | (9) |
337,000 | — | — | |||||||||||
— | — | 100,000 | (5) |
337,000 | ||||||||||||
John F. Thero (10) |
72,033 | (5) |
242,751 | — | — | |||||||||||
118,733 | (6) |
400,130 | — | — | ||||||||||||
382,733 | (3) |
1,289,810 | — | — | ||||||||||||
— | — | 490,200 | (5) |
1,651,974 | ||||||||||||
— | — | 490,200 | (5) |
1,651,974 | ||||||||||||
Joseph T. Kennedy (11) |
12,733 | (5) |
42,910 | — | — | |||||||||||
32,666 | (6) |
110,084 | — | — | ||||||||||||
95,533 | (3) |
321,946 | — | — | ||||||||||||
— | — | 50,000 | (5) |
168,500 | ||||||||||||
— | — | 87,400 | (5) |
294,538 | ||||||||||||
— | — | 87,400 | (5) |
294,538 |
(1) | The market value of the restricted stock unit awards represents the product of the closing price of our stock as of December 31, 2021, the last trading day of the year, which was $3.37, and the number of shares underlying each such award and, with respect to performance-based awards, assumes satisfaction of the applicable performance criteria. |
(2) | These restricted stock unit awards vest in equal annual installments over three years, commencing July 1, 2021. Amount unvested at December 31, 2021 represents the remaining two vesting tranches. |
(3) | These restricted stock unit awards vest in equal annual installments over three years, commencing December 31, 2021. Amount unvested at December 31, 2021 represents the remaining two vesting tranches. |
(4) | These restricted stock unit awards vest in equal annual installments over three years, commencing April 12, 2022. |
(5) | These restricted stock unit awards vest upon achievement of certain sales and operational performance goals. To date, the specified criterion has not been achieved. |
(6) | These restricted stock unit awards vest in equal annual installments over three years, commencing January 31, 2020. Amount unvested at December 31, 2021 represents the third and final tranche. |
(7) | These restricted stock unit awards vest in equal annual installments over three years, commencing February 28, 2021. Amount unvested at December 31, 2021 represents the remaining two vesting tranches. |
(8) | These restricted stock unit awards vest in equal annual installments over three years, commencing July 31, 2022. |
(9) | These restricted stock unit awards vest in equal annual installments over three years, commencing August 19, 2022. |
(10) | Mr. Thero’s restricted stock unit awards stopped vesting at the conclusion of his consultancy period with the Company on February 28, 2022. |
(11) | Mr. Kennedy’s restricted stock unit awards stopped vesting at the conclusion of his consultancy period with the Company on March 31, 2022. |
• | Dr. Ketchum, Mr. Kalb, Mr. Berg and Mr. Marks will be entitled to a lump sum cash payment equal to 1.5 times the sum of such named executive officer’s base salary plus such named executive officer’s target annual performance bonus for the year in which termination occurs or, if higher, the target annual performance bonus in effect as of immediately prior to the change of control (the higher of such amounts, the “Target Bonus”), continuation of group health plan benefits for up to 18 months and accelerated vesting of all of such named executive officer’s then-outstanding stock options, restricted stock units or other equity incentive awards (whether or not subject to time-based vesting) (the “Outstanding Equity Awards”); and |
• | Mr. Mikhail will be entitled to continuation of his base salary for 24 months, a lump sum cash payment equal to 2.0 times his Target Bonus, continuation of group health plan benefits for up to 24 months and accelerated vesting of all of his Outstanding Equity Awards. |
• | Dr. Ketchum, Mr. Kalb, Mr. Berg and Mr. Marks will be entitled to continuation of such named executive officer’s base salary for 12 months, continuation of group health plan benefits for up to 12 months and six months of accelerated vesting of such named executive officer’s Outstanding Equity Awards; and |
• | Mr. Mikhail will be entitled to continuation of his base salary for 18 months, an amount equal to 1.5 times his Target Bonus to be paid in substantially equal installments over the course of 18 months, continuation of group health plan benefits for up to 18 months and 12 months of accelerated vesting of his Outstanding Equity Awards. |
Name |
Base Salary ($) |
Bonus Payment ($) |
Accelerated Vesting of Options(1) ($) |
Accelerated Vesting of Restricted Stock Units(2) ($) |
Continuation of Health Benefits ($) |
Total ($) |
||||||||||||||||||
Karim Mikhail |
1,500,000 | 1,050,000 | — | 2,374,499 | 18,000 | 4,942,499 | ||||||||||||||||||
Steven B. Ketchum, Ph.D. |
900,000 | 450,000 | — | 1,473,977 | 51,000 | 2,874,977 | ||||||||||||||||||
Michael W. Kalb |
712,800 | 356,400 | — | 1,715,438 | 51,000 | 2,835,638 | ||||||||||||||||||
Aaron D. Berg |
825,000 | 412,500 | 6,945 | 1,473,977 | 52,000 | 2,770,422 | ||||||||||||||||||
Jason Marks |
712,500 | 356,250 | — | 674,000 | 52,000 | 1,794,750 | ||||||||||||||||||
John F. Thero |
— | 536,738 | — | 5,236,640 | — | 5,773,378 | ||||||||||||||||||
Joseph T. Kennedy |
— | 216,824 | — | 1,232,517 | — | 1,449,341 |
(1) | The value of the accelerated vesting of options equals the difference (if positive) between the option exercise price and the closing price per share of our ADSs on December 31, 2021 ($3.37), multiplied by the number of shares that would have been accelerated upon a termination occurring on December 31, 2021. |
(2) | The value of the accelerated vesting of restricted stock units equals the closing price per share of our ADSs on December 31, 2021 ($3.37) multiplied by the number of restricted stock units that would have been accelerated upon a termination occurring on December 31, 2021. Included in these amounts are amounts related to performance-based restricted stock units that would vest upon a change in control of $1,348,000 for Mr. Mikhail, $757,576 for each of Dr. Ketchum, Mr. Kalb, Mr. Berg, and Mr. Kennedy, $337,000 for Mr. Marks, and $3,303,948 for Mr. Thero. |
Name |
Base Salary ($) |
Bonus Payment ($) |
Accelerated Vesting of Options(1) ($) |
Accelerated Vesting of Restricted Stock Units(2) ($) |
Continuation of Health Benefits ($) |
Total ($) |
||||||||||||||||||
Karim Mikhail |
1,125,000 | 787,500 | — | 392,383 | 14,000 | 2,318,883 | ||||||||||||||||||
Steven B. Ketchum, Ph.D. |
600,000 | — | — | 97,952 | 34,000 | 731,952 | ||||||||||||||||||
Michael W. Kalb |
475,200 | — | — | 97,952 | 34,000 | 607,152 | ||||||||||||||||||
Aaron D. Berg |
550,000 | — | 6,945 | 97,952 | 35,000 | 689,897 | ||||||||||||||||||
Jason Marks |
475,000 | — | — | — | 35,000 | 510,000 | ||||||||||||||||||
John F. Thero |
— | 536,738 | — | 442,818 | — | 979,556 | ||||||||||||||||||
Joseph T. Kennedy |
— | 216,824 | — | 97,952 | — | 314,776 |
(1) | The value of the accelerated vesting of time-based options equals the difference (if positive) between the option exercise price and the closing price per share of our ADSs on December 31, 2021 ($3.37), multiplied by the number of shares that would have been accelerated upon termination. |
(2) | The value of the accelerated vesting of time-based restricted stock units equals the closing price per share of our ADSs on December 31, 2021 ($3.37) multiplied by the number of time-based restricted stock units that would have been accelerated upon termination. |
PEO 2021 Compensation |
$ | 5,911,806 | ||
Median Employee 2021 Compensation |
$ | 139,852 | ||
Ratio of PEO to Median Employee Compensation |
42 |
Retainer ($) |
||||
Annual Board Retainer Fee: |
||||
Non-Executive Chairman |
95,000 | |||
All non-employee directors |
62,500 | |||
Annual Chairman Retainer Fees:* |
||||
Audit Committee Chairman |
25,000 | |||
Remuneration Committee Chairman |
20,000 | |||
Nominating and Corporate Governance Committee Chairman |
11,000 | |||
Annual Committee Member Retainer Fees:* |
||||
Audit Committee |
12,000 | |||
Remuneration Committee |
10,000 | |||
Nominating and Corporate Governance Committee |
5,000 |
* | These fees are in addition to the Annual Board Retainer Fee, as applicable. |
Name |
Fees Earned or Paid in Cash ($) |
Stock Awards(1)(3) ($) |
Option Awards(2)(3) ($) |
Total ($) |
||||||||||||
Lars G. Ekman, M.D., Ph.D. |
100,000 | 190,000 | 190,004 | 480,004 | ||||||||||||
Jan van Heek |
97,500 | 180,000 | 180,003 | 457,503 | ||||||||||||
Patrick J. O’Sullivan |
85,500 | 180,000 | 180,003 | 445,503 | ||||||||||||
Kristine Peterson |
84,500 | 180,000 | 180,003 | 444,503 | ||||||||||||
David Stack |
82,500 | 180,000 | 180,003 | 442,503 | ||||||||||||
Joseph S. Zakrzewski |
67,500 | 180,000 | 180,003 | 427,503 |
(1) | The value of the stock awards reflects the aggregate grant date fair value, calculated in accordance with FASB ASC 718, excluding the effect of estimated forfeitures. Assumptions used in the calculations for these amounts are set forth in Note 11 to our consolidated financial statements included in the Original Form 10-K Filing. |
(2) | The value of the option awards reflects the aggregate grant date fair value, calculated in accordance with FASB ASC 718 using the Black-Scholes option-pricing model, excluding the effect of estimated forfeitures. Assumptions used in the calculations for these amounts are set forth in Note 11 to our consolidated financial statements included in the Original Form 10-K Filing. |
(3) | The following table shows the amount of unexercised stock options, unvested stock unit awards and vested stock unit awards subject to deferred delivery as of December 31, 2021: |
Unexercised Unvested Stock Options |
Unexercised Vested Stock Options |
Unvested Stock Awards |
Vested but Deferred Stock Awards |
|||||||||||||
Lars G. Ekman, M.D., Ph.D. |
48,506 | 47,170 | 59,808 | 193,123 | ||||||||||||
Jan van Heek |
45,953 | 166,584 | 56,603 | 171,923 | ||||||||||||
Patrick J. O’Sullivan |
45,953 | 253,931 | 56,603 | 171,923 | ||||||||||||
Kristine Peterson |
45,953 | 210,431 | 56,603 | 171,923 | ||||||||||||
David Stack |
45,953 | 44,463 | 56,603 | 171,923 | ||||||||||||
Joseph S. Zakrzewski |
45,953 | 210,431 | 56,603 | 162,923 |
Item 12. |
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters |
Shares Beneficially Owned |
||||||||
Name and Address of Beneficial Owner |
Number |
Percent of Class |
||||||
Greater than 5% Holders: |
||||||||
Baker Bros. Advisors LP (1) |
21,169,805 |
5.33 |
||||||
Sarissa Capital Management LP (2) |
24,000,000 |
6.05 |
||||||
Current directors and named executive officers: |
||||||||
Karim Mikhail (3) |
212,809 |
* | ||||||
Lars G. Ekman, M.D., Ph.D. (4) |
47,170 |
* | ||||||
Jan van Heek (5) |
180,752 |
* | ||||||
Patrick J. O’Sullivan (6) |
253,931 |
* | ||||||
Per Wold-Olsen (7) |
94,000 |
* | ||||||
Kristine Peterson (8) |
210,431 |
* | ||||||
David Stack (9) |
84,463 |
* | ||||||
Joseph S. Zakrzewski (10) |
406,978 |
* | ||||||
Steven B. Ketchum, Ph.D. (11) |
686,819 |
* | ||||||
Michael W. Kalb (12) |
588,967 |
* | ||||||
Aaron D. Berg (13) |
797,686 |
* | ||||||
Jason Marks |
— |
— |
||||||
John F. Thero (14) |
7,774,730 |
1.94 |
||||||
Joseph T. Kennedy (15) |
613,708 |
* | ||||||
All current directors and executive officers as a group (12 persons) (16) |
3,564,006 |
* |
* |
Represents beneficial ownership of less than one percent. |
(1) |
Based on information provided in an Amendment No. 6 to Schedule 13G filed by Baker Bros. Advisors LP, Baker Bros. Advisors (GP) LLC, Felix J. Baker and Julian C. Baker on February 14, 2022. Consists of (i) 1,784,805 shares held by 667, L.P. and (ii) 19,385,000 shares held by Baker Brothers Life Sciences, L.P., or collectively with 667, L.P., the Baker Funds. Baker Bros. Advisors LP is the investment advisor to the Baker Funds and has sole voting and investment power with respect to the shares held by the Baker Funds. Baker Bros. Advisors (GP) LLC is the sole general partner of Baker Bros. Advisors LP. The managing members of Baker Bros. Advisors (GP) LLC are Julian C. Baker and Felix J. Baker. Julian C. Baker and Felix J. Baker disclaim beneficial ownership of all shares except to the extent of their pecuniary interest. Each of Julian C. Baker and Felix J. Baker holds 123,372 ordinary shares not reflected in the table. The address for each of these entities is 860 Washington Street, 3rd Floor, New York, NY 10014. |
(2) |
Based on information provided in a Schedule 13D filed by Sarissa Capital Management LP and Alexander J. Denner on January 24, 2022. Sarissa Capital Management LP and the fund and other private investment vehicles for which Sarissa Capital Management LP acts as the investment advisor own the shares. Sarissa Capital Management LP has the authority to vote and to dispose of the shares. Alexander J. Denner is the Chief Investment Officer, and the ultimate general partner, of Sarissa Capital Management LP, and, by virtue of such positions, may be deemed to have beneficial ownership of the shares. The address for Sarissa Capital Management LP and Alexander J. Denner is 660 Steamboat Road, Greenwich, CT 06830. |
(3) |
Includes 31,031 Shares directly owned, 130,675 Shares issuable upon the exercise of options exercisable within 60 days of March 31, 2022, and 51,103 Shares issuable upon the vesting of RSUs within 60 days of March 31, 2022. |
(4) |
Includes 47,170 Shares issuable upon the exercise of options exercisable within 60 days of March 31, 2022. |
(5) |
Includes 14,168 Shares directly owned and 166,584 Shares issuable upon the exercise of options exercisable within 60 days of March 31, 2022. |
(6) |
Includes 253,931 Shares issuable upon the exercise of options exercisable within 60 days of March 31, 2022. |
(7) |
Includes 94,000 Shares directly owned. |
(8) |
Includes 210,431 Shares issuable upon the exercise of options exercisable within 60 days of March 31, 2022. |
(9) |
Includes 40,000 Shares directly owned and 44,463 Shares issuable upon the exercise of options exercisable within 60 days of March 31, 2022. |
(10) |
Includes 196,547 Shares directly owned and 210,431 Shares issuable upon the exercise of options exercisable within 60 days of March 31, 2022. |
(11) |
Includes 496,912 Shares directly owned and 189,907 Shares issuable upon the exercise of options exercisable within 60 days of March 31, 2022. |
(12) |
Includes 250,747 Shares directly owned and 338,220 Shares issuable upon the exercise of options exercisable within 60 days of March 31, 2022. |
(13) |
Includes 392,084 Shares directly owned and 405,602 Shares issuable upon the exercise of options exercisable within 60 days of March 31, 2022. |
(14) |
Includes 3,252,752 Shares directly owned per his final Form 4 filed on August 3, 2021 and 4,521,978 Shares issuable upon the exercise of options exercisable within 60 days of March 31, 2022. |
(15) |
Includes 317,860 Shares directly owned per his final Form 4 filed on August 3, 2021 and 295,848 Shares issuable upon the exercise of options exercisable within 60 days of March 31, 2022. |
(16) |
Includes an aggregate of 1,515,489 Shares directly owned, 1,997,414 Share issuable upon the exercise of options exercisable within 60 days of March 31, 2022 and 51,103 Shares issuable upon the vesting of RSUs within 60 days of March 31, 2022 held by our directors and executive officers as a group. |
Plan Category |
Number of Securities to be Issued Upon Exercise of Outstanding Options, Warrants and Rights |
Weighted-Average Exercise Price of Outstanding Options, Warrants and Rights |
Number of Securities Remaining Available for Future Issuance Under Equity Compensation Plans (Excluding Securities Reflected in the First Column) |
|||||||||
Equity compensation plans approved by stockholders |
27,770,479 |
(1) |
$ |
7.32 |
(2) |
15,047,319 |
(3) | |||||
Equity compensation plans not approved by stockholders |
— |
— |
— |
|||||||||
Total |
27,770,479 |
(1) |
$ |
7.32 |
(2) |
15,047,319 |
(3) |
(1) |
Includes 18,493,303 shares issuable upon the exercise of outstanding options and 9,277,176 shares issuable upon the vesting of restricted stock units. |
(2) |
Represents the weighted-average exercise price of options outstanding under the 2020 Plan and the 2011 Plan. The weighted-average exercise price does not take into account restricted stock unit awards since such awards have no exercise price. |
(3) |
As of December 31, 2021, a total of 13,229,046 shares were reserved for issuance pursuant to the 2020 Plan and a total of 1,818,273 shares were reserved for issuance pursuant to the ESPP. No shares were available for grant under our 2011 Plan. |
Item 13. |
Certain Relationships and Related Transactions, and Director Independence |
Item 14. |
Principal Accountant Fees and Services |
2021 |
2020 |
|||||||
Audit Fees (1) : |
$ |
1,595,277 |
$ |
1,600,763 |
||||
Audit-Related Fees: |
$ |
— |
$ |
— |
||||
Tax Fees (2) : |
$ |
6,750 |
$ |
22,833 |
||||
All Other Fees: |
$ |
— |
$ |
— |
||||
Total All Fees: |
$ |
1,602,027 |
$ |
1,623,596 |
(1) |
Audit fees for 2021 include fees incurred in connection with the audit of our financial statements as of December 31, 2021, as prepared in accordance with U.S. Generally Accepted Accounting Principles, costs |
incurred in connection with the audit of statutory financial statements as of December 31, 2021, as prepared in accordance with International Financial Reporting Standards, and costs incurred in connection with registration statement filings. |
(2) |
Tax fees consist primarily of tax advisory fees and costs incurred for the preparation of tax returns and other related statutory filings. |
Item 15. |
Exhibit and Financial Statement Schedules |
Exhibit Number |
Incorporated by Reference Herein | |||||
Description |
Form |
Date | ||||
3.1 |
Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2013, as Exhibit 3.1 |
August 8, 2013 | ||||
4.1 |
Annual Report on Form 10-K for the year ended December 31, 2011, as Exhibit 4.1 |
February 29, 2012 | ||||
4.2 |
Annual Report on Form 20-F for the year ended December 31, 2002, as Exhibit 2.4 |
April 24, 2003 | ||||
4.3 |
Annual Report on Form 10-K for the year ended December 31, 2011, as Exhibit 4.4 |
February 29, 2012 | ||||
4.4 |
Annual Report on Form 10-K for the year ended December 31, 2019, as Exhibit 4.7 |
February 25, 2020 | ||||
10.1 |
Annual Report on Form 20-F for the year ended December 31, 2006, as Exhibit 4.17 |
March 5, 2007 | ||||
10.2 |
Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2011, as Exhibit 10.4 |
August 9, 2011 | ||||
10.3 |
Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2012, as Exhibit 10.1 |
August 8, 2012 | ||||
10.4 |
Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2012, as Exhibit 10.2 |
August 8, 2012 | ||||
10.5 |
Annual Report on Form 10-K for the year ended December 31, 2012, as Exhibit 10.5 |
February 28, 2013 | ||||
10.6 |
Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2015, as Exhibit 4.1 |
August 6, 2015 | ||||
10.7 |
Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2015, as Exhibit 4.2 |
August 6, 2015 | ||||
10.8 |
Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2017, as Exhibit 4.1 |
August 2, 2017 |
10.9 |
Annual Report on Form 10-K for the year ended December 31, 2010, as Exhibit 10.44 |
March 16, 2011 | ||||
10.10 |
Annual Report on Form 10-K for the year ended December 31, 2011, as Exhibit 10.3 |
February 29, 2012 | ||||
10.11 |
Annual Report on Form 10-K for the year ended December 31, 2011, as Exhibit 10.4 |
February 29, 2012 | ||||
10.12 |
Annual Report on Form 10-K for the year ended December 31, 2011, as Exhibit 10.5 |
February 29, 2012 | ||||
10.13 |
Annual Report on Form 10-K for the year ended December 31, 2017, as Exhibit 10.64 |
February 27, 2018 | ||||
10.14 |
Current Report on Form 8-K dated July 13, 2020, as Exhibit 10.1 |
July 14, 2020 | ||||
10.15 |
Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020, as Exhibit 10.2 |
November 5, 2020 | ||||
10.16 |
Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020, as Exhibit 10.3 |
November 5, 2020 | ||||
10.17 |
Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020, as Exhibit 10.4 |
November 5, 2020 | ||||
10.18 |
Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020, as Exhibit 10.5 |
November 5, 2020 | ||||
10.19 |
Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020, as Exhibit 10.6 |
November 5, 2020 | ||||
10.20 |
Current Report on Form 8-K dated January 28, 2021, as Exhibit 10.1 |
January 29, 2021 | ||||
10.21 |
Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2021, as Exhibit 10.4 |
April 29, 2021 | ||||
10.22 |
Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2021, as Exhibit 10.1 |
November 3, 2021 | ||||
10.23 |
Registration Statement on Form F-1, as Exhibit 10.1 |
February 28, 2012 | ||||
10.24 |
Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2015, as Exhibit 10.2 |
August 6, 2015 |
10.25 |
Registration Statement on Form S-8, as Exhibit 4.2 |
March 16, 2012 | ||||
10.26 |
Current Report on Form 8-K dated June 30, 2016, as Exhibit 10.1 |
June 30, 2016 | ||||
10.27 |
Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2019, as Exhibit 10.1 |
May 1, 2019 | ||||
10.28 |
Current Report on Form 8-K dated January 8, 2014, as Exhibit 10.1 |
January 10, 2014 | ||||
10.29 |
Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2015, as Exhibit 10.3 |
August 6, 2015 | ||||
10.30 |
Current Report on Form 8-K dated April 12, 2021, File No. 0-21392, as Exhibit 10.1 |
April 12, 2021 | ||||
10.31 |
Current Report on Form 8-K dated December 23, 2011, as Exhibit 10.5 |
December 23, 2011 | ||||
10.32 |
Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2015, as Exhibit 10.1 |
August 6, 2015 | ||||
10.33 |
Registration Statement on Form S-8, as Exhibit 4.1 |
March 16, 2012 | ||||
10.34 |
Current Report on Form 8-K dated April 28, 2021, as Exhibit 10.1 |
April 29, 2021 | ||||
10.35 |
Annual Report on Form 10-K for the year ended December 31, 2021, as Exhibit 10.35 |
March 1, 2022 | ||||
10.36 |
Annual Report on Form 10-K for the year ended December 31, 2021, as Exhibit 10.36 |
March 1, 2022 | ||||
10.37 |
Annual Report on Form 10-K for the year ended December 31, 2021, as Exhibit 10.37 |
March 1, 2022 | ||||
10.38 |
Annual Report on Form 10-K for the year ended December 31, 2021, as Exhibit 10.38 |
March 1, 2022 |
10.39 |
Annual Report on Form 10-K for the year ended December 31, 2017, as Exhibit 10.66 |
February 27, 2018 | ||||
10.40 |
Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2014, as Exhibit 10.1 |
May 9, 2014 | ||||
10.41 |
Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2017, as Exhibit 10.1 |
August 2, 2017 | ||||
10.42 |
Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2015, as Exhibit 10.1 |
May 8, 2015 | ||||
10.43 |
Annual Report on Form 10-K for the year ended December 31, 2017, as Exhibit 10.67 |
February 27, 2018 | ||||
10.44 |
Annual Report on Form 10-K for the year ended December 31, 2017, as Exhibit 10.68 |
February 27, 2018 | ||||
10.45 |
Annual Report on Form 10-K for the year ended December 31, 2018, as Exhibit 10.69 |
February 27, 2019 | ||||
10.46 |
Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2019, as Exhibit 10.2 |
July 31, 2019 | ||||
10.47 |
Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2019, as Exhibit 10.3 |
July 31, 2019 | ||||
10.48 |
Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2019, as Exhibit 10.4 |
July 31, 2019 |
10.49 |
Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020, as Exhibit 10.7 |
November 5, 2020 | ||||
10.50 |
Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020, as Exhibit 10.8 |
November 5, 2020 | ||||
10.51 |
Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2020, as Exhibit 10.1 |
April 30, 2020 | ||||
10.52 |
Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2021, as Exhibit 10.1 |
April 29, 2021 | ||||
10.53 |
Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2021, as Exhibit 10.2 |
April 29, 2021 | ||||
10.54 |
Annual Report on Form 10-K for the year ended December 31, 2021, as Exhibit 10.54 |
March 1, 2022 | ||||
10.55 |
Annual Report on Form 10-K for the year ended December 31, 2021, as Exhibit 10.55 |
March 1, 2022 | ||||
10.56 |
Annual Report on Form 10-K for the year ended December 31, 2021, as Exhibit 10.56 |
March 1, 2022 | ||||
21.1 |
Annual Report on Form 10-K for the year ended December 31, 2021, as Exhibit 21.1 |
March 1, 2022 | ||||
23.1 |
Annual Report on Form 10-K for the year ended December 31, 2021, as Exhibit 23.1 |
March 1, 2022 | ||||
24.1 |
Included on the signature page(s) to the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 |
March 1, 2022 | ||||
31.1 |
Annual Report on Form 10-K for the year ended December 31, 2021, as Exhibit 31.1 |
March 1, 2022 | ||||
31.2 |
Annual Report on Form 10-K for the year ended December 31, 2021, as Exhibit 31.2 |
March 1, 2022 |
31.3 |
Certification of President and Chief Executive Officer (Principal Executive Officer) pursuant to Section 302 of Sarbanes-Oxley Act of 2002 | Filed herewith. | ||||
31.4 |
Certification of Senior Vice President and Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) pursuant to Section 302 of Sarbanes-Oxley Act of 2002 | Filed herewith. | ||||
32.1 |
Certification of President and Chief Executive Officer (Principal Executive Officer) and Senior Vice President and Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) pursuant to Section 906 of Sarbanes-Oxley Act of 2002 | Furnished with Annual Report on Form 10-K for the year ended December 31, 2021, as Exhibit 32.1 |
March 1, 2022 | |||
101.INS |
Inline XBRL Instance Document | Filed herewith | ||||
101.SCH |
Inline XBRL Taxonomy Extension Schema Document | Filed herewith | ||||
101. CAL |
Inline XBRL Taxonomy Extension Calculation Linkbase Document | Filed herewith | ||||
101. DEF |
Inline XBRL Taxonomy Extension Definition Linkbase Document | Filed herewith | ||||
101. LAB |
Inline XBRL Taxonomy Extension Label Linkbase Document | Filed herewith | ||||
101. PRE |
Inline XBRL Taxonomy Extension Presentation Linkbase Document | Filed herewith | ||||
104 |
Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101.) | Filed herewith |
†† | Confidential treatment has been granted with respect to portions of this exhibit pursuant to an application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934. A complete copy of this exhibit, including the redacted terms, has been separately filed with the Securities and Exchange Commission. |
** | Certain confidential portions (indicated by brackets and asterisks) have been omitted from this exhibit. |
* | Management contract or compensatory plan or arrangement. |
AMARIN CORPORATION PLC | ||
By: | /s/ Karim Mikhail | |
Karim Mikhail | ||
President Chief Executive Officer |
EXHIBIT 31.3
CERTIFICATION
I, Karim Mikhail, certify that:
1. | I have reviewed this Amendment No. 1 to Annual Report on Form 10-K of Amarin Corporation plc; and |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report. |
Date: May 2, 2022 | /s/ Karim Mikhail | |||||
Karim Mikhail | ||||||
President and Chief Executive Officer (Principal Executive Officer) |
EXHIBIT 31.4
CERTIFICATION
I, Michael W. Kalb, certify that:
1. | I have reviewed this Amendment No. 1 to Annual Report on Form 10-K of Amarin Corporation plc; and |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report. |
Date: May 2, 2022 | /s/ Michael W. Kalb | |||||
Michael W. Kalb | ||||||
Senior Vice President and Chief Financial Officer | ||||||
(Principal Financial Officer and Principal Accounting Officer) |