Item 9A. Controls and Procedures
Item 9A. Controls and Procedures
Disclosure Controls and Procedures
Management of the Company maintains disclosure controls and procedures as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, as amended, that are designed to ensure that information required to be disclosed in the reports that are filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the Securities and Exchange Commission. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act is accumulated and communicated to management, including the Chief Executive Officer and the Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Management has carried out an evaluation, under the supervision and with the participation of the Chief Executive Officer and the Chief Financial Officer, of the effectiveness of the disclosure controls and procedures. Based on that evaluation, the Chief Executive Officer and Chief Financial Officer concluded that the Company's disclosure controls and procedures were not effective as of December 31, 2023, due to the material weaknesses as discussed further below under the heading “Management’s Annual Report on Internal Control over Financial Reporting” in this Item 9.
Management’s Annual Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) to provide reasonable assurance regarding the reliability of our financial reporting and the preparation of consolidated financial statements for external purposes in accordance with generally accepted accounting principles.
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Our internal control over financial reporting includes policies and procedures that pertain to the maintenance of records that, in reasonable detail, accurately and fairly, reflect transactions and dispositions of assets, provide reasonable assurance that transactions are recorded in the manner necessary to permit the preparation of the consolidated financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures are only carried out in accordance with the authorization of our management and directors, and provide reasonable assurance regarding the prevention or timely detection of any unauthorized acquisition, use or disposition of our assets that could have a material effect on our financial statements. Our internal control over financial reporting includes controls over relevant IT systems that have an impact on financial reporting including accuracy and completeness of our account balances.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Management assessed the effectiveness of our internal control over financial reporting as of December 31, 2023, based on the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission Internal Control-Integrated Framework (2013). Management concluded that the Company's internal control over financial reporting was not effective as of December 31, 2023 due to the existence of the material weaknesses described below.
In connection with the preparation of our financial statements as of December 31, 2023 and 2022 and for the three years in the period ended December 31. 2023, we identified the following material weaknesses in our internal control over financial reporting:
• a lack of consistent and documented risk assessment procedures and control activities related to financial reporting, with a sufficient level of management review and approval, and adequate application of controls over information technology; and
• failure to maintain a sufficient complement of personnel commensurate with its accounting and reporting requirements as it continues to grow as a company, and ability to: (i) design and maintain formal accounting policies, including maintaining appropriate segregation of duties; (ii) design and maintain controls over the preparation and review of journal entries and financial statements, including the fair presentation and disclosure of complex accounting matters.
Our management, under the oversight of the Audit Committee, is committed to implement, strengthen and maintain a strong internal control environment and continued taking steps in fiscal year 2023 to execute its remediation plan including by taking the following measures:
• performed a detailed risk assessment;
• hired additional internal and external accounting resources, including third-party internal control advisors and technical accounting advisors;
• redesigned and documented critical processes and controls associated with internal control over financial reporting;
• designed and maintained formal accounting policies;
• designed and implemented procedures and controls over the fair presentation of our financial statements;
• implemented a new enterprise resource planning system;
• established proper segregation of duties and management review and approvals across all key business processes, applications and controls over information technology;
• designed and implemented controls over the preparation and review of journal entries and financial statements;
• designed and implemented controls over financial reporting and information technology; and
• implemented management audit tooling to follow up on control performance.
Although the above listed measures were implemented during the year ended December 31, 2023, our management is still in the process of testing the implemented controls and refining the remediation plan based on the results. Therefore, management does not consider the identified material weaknesses to be fully remediated yet. Management is committed to further strengthen its internal control environment in fiscal year 2024.
Notwithstanding the material weaknesses, management has concluded that our audited financial statements included in this Annual Report on Form 10-K are fairly stated in all material respects in accordance with U.S. GAAP for each of the periods presented herein.
Attestation Report of the Registered Public Accounting Firm
This Annual Report does not include an attestation report on the Company’s internal control over financial reporting from the Company's registered public accounting firm due to a transition period established by rules of the SEC for newly public companies and because we are an emerging growth company under the JOBS Act.
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Changes in Internal Controls over Financial Reporting
Other than the implementation of the remediation plan related to the material weaknesses noted above, there have been no significant changes in the Company's internal control over financial reporting that have occurred during the period covered by this Annual Report that have materially affected or are reasonably likely to materially affect our internal control over financial reporting.
Item 9B. Other Information
Securities Trading Plans of Directors and Executive Officers
During the three months ended December 31, 2023, none of our directors or executive officers adopted or terminated any contract, instruction or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) or any “non-Rule 10b5-1 trading arrangement.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
None.
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PART III
Item 10. Directors, Executive Officers and Corporate Governance
Current Directors and Executive Officers
The Board of Directors
Set forth below are the names and certain information about each of our directors as of February 28, 2024. The information presented includes each director’s age, term and principal occupation. Biographical information for each director is included below the table.
Name
Positions and Offices Held
Year in which Term Expires
Age
Employee Directors
Michael Davidson, M.D.
Chief Executive Officer, Executive Director
2025
67
John Kastelein, M.D., Ph.D. FESC
Chief Scientific Officer, Non-Executive Director
2027
70
Non-Employee Directors
William H. Lewis, J.D., M.B.A.*
Chair, Non-Executive Director
N/A
55
Juliette Audet
Vice Chair, Non-Executive Director
2024
38
Nicholas Downing, M.D.
Non-Executive Director
2027
38
Louis Lange, M.D., Ph.D
Non-Executive Director
2024
75
Sander Slootweg
Non-Executive Director
2027
55
John W. Smither
Non-Executive Director
2026
71
James N. Topper, M.D., Ph.D.
Non-Executive Director
2025
62
Janneke van der Kamp
Non-Executive Director
2026
48
* William H. Lewis was appointed by the Board of Directors as temporary non-executive director on January 4, 2024 to fulfill a vacant position within the Board of Directors until his proposed appointment by the General Meeting at the next annual General Meeting.
Employee Directors
Dr. Michael Davidson . Michael Davidson, M.D., has served as our Chief Executive Officer and executive director since November 2022. Dr. Davidson served NewAmsterdam Pharma as its Chief Executive Officer and an executive director from August 2020 to November 2022. Prior to joining NewAmsterdam Pharma, Dr. Davidson was the founder and Chief Executive Officer of Corvidia Therapeutics, Inc. from January 2016 until April 2018 and the Chief Science/Medical Officer from April 2018 until July 2020, when Corvidia was acquired by Novo Nordisk A/S for up to $2.1 billion. Dr. Davidson, who is a leading expert in the field of lipidology and was named in The Best Doctors in America for the past 15 years, is also currently a professor of medicine and director of the lipid clinic at the University of Chicago. Dr. Davidson co-founded and served as the Chief Medical Officer of Omthera Pharmaceuticals, Inc. in 2008, which was later acquired by AstraZeneca Pharmaceuticals in 2013 for up to $443 million. His research background encompasses both pharmaceutical and nutritional clinical trials including extensive research on statins, novel lipid-lowering drugs, and omega-3 fatty acids. Dr. Davidson is board-certified in internal medicine, cardiology, and clinical lipidology and served as President of the National Lipid Association from 2010 to 2011. Dr. Davidson currently serves on the board of directors of Tenax Therapeutics, Inc. (Nasdaq: TENX) and Silence Therapeutics plc (Nasdaq: SLN). Dr. Davidson also serves on the boards of two private biotechnology companies, Sonothera and NanoPhoria Bioscience. Dr. Davidson received his B.A. and M.S. from Northwestern University and his M.D. from The Ohio State University School of Medicine.
We believe Dr. Davidson’s extensive experience in the field of cardiology and his prior management experience provide him the qualifications and skills to serve on the Board of Directors.
Dr. John Kastelein . John Kastelein, M.D., Ph. D. FESC, has served as our Chief Scientific Officer and non-executive director since November 2022. Dr. Kastelein co-founded NewAmsterdam Pharma in 2020 served as its Chief Scientific Officer and an executive director from January 1, 2020 to November 2022. Dr. Kastelein has also served as the chief executive officer of Vascular Research Network Inc. (“VRN”) since January 2013 and as the Chief Medical Officer of Staten Biotechnology B.V. since January 2018. Dr. Kastelein also serves as emeritus professor of medicine and was the chair of the department of vascular medicine at the Academic Medical Center of the University of Amsterdam. He serves on the advisory board of the Dutch Atherosclerosis Society. In 2011 he received the ZonMw Pearl for his research in the field of gene therapy. Dr. Kastelein also serves on the board of directors of North Sea Therapeutics Inc., VRN and Oxitope Pharma Inc. Dr. Kastelein also serves as an advisor to a number of biotech and pharmaceutical companies. Dr. Kastelein was awarded a doctorate in medicine (with honors) from the University of Amsterdam, trained in internal medicine at the Academic Medical Center of the University of Amsterdam, and trained in lipidology and molecular biology at the University of British Columbia in Vancouver. Dr. Kastelein published his first clinical research on CETP-inhibition in the New England Journal of Medicine in 1997.
We believe Dr. Kastelein’s deep scientific and medical knowledge about NewAmsterdam Pharma’s product candidate and his experience in senior management, provide Dr. Kastelein with the qualifications and skills to serve on the Board of Directors.
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Non-Employee Directors
William H. Lewis, J.D., M.B.A. William H. Lewis has served as a member of the Board of Directors and Chair since January 2024. Mr. Lewis was appointed as temporary non-executive director in fulfilment of a vacant position within the Board of Directors until his proposed appointment by the General Meeting at the next annual General Meeting. Mr. Lewis has more than 30 years of executive experience in the pharmaceutical and finance industries both in the U.S. and internationally. Mr. Lewis has served as President, Chief Executive Officer and director at Insmed Incorporated (“Insmed”) since 2012 and has served as Chair of Insmed’s board of directors since November 2018. Prior to joining Insmed in 2012, Mr. Lewis served as Co-Founder, President, and Chief Financial Officer of Aegerion Pharmaceuticals, Inc. from 2005 until 2011. Prior to Mr. Lewis’ time at Aegerion, he spent approximately 10 years working in investment banking in the U.S. and Europe. He also previously worked for the U.S. government. Mr. Lewis holds a J.D. with Honors and an M.B.A., both from Case Western Reserve University, and a B.A., cum laude , from Oberlin College. He is a member of the Board of Trustees of Case Western Reserve University and of BioNJ, the life sciences association for New Jersey.
We believe that Mr. Lewis’ significant experience as a public company executive in the life sciences industry and his other professional experience in the finance industry provide him the qualifications and skills to serve on the Board of Directors.
Juliette Audet . Juliette Audet has served as a member of the Board of Directors since November 2022. Ms. Audet previously served on the NewAmsterdam Pharma board from 2020 until November 2022. Ms. Audet has been a partner at Forbion since January 2021 and served as a principal at Forbion from October 2019 until December 2020. Prior to joining Forbion, Ms. Audet was a Principal at Novartis Venture Fund based in Cambridge, Massachusetts from January 2018 until July 2019. Ms. Audet currently serves on the board of directors of Mestag Therapeutics Limited. Ms. Audet received an M.B.A., with distinction, from Harvard Business School and her M.Sc in physics from EPFL (Lausanne, Swiss Federal Institute of Technology).
We believe that Ms. Audet’s extensive experience in investing in life science companies and her managerial experience provide her the qualifications and skills to serve on the Board of Directors.
Dr. Nicholas S. Downing . Nicholas S. Downing, M.D., has served as a member of the Board of Directors since November 2022. Dr. Downing serves as a Managing Director of Bain Capital Life Sciences, L.P., a private equity fund that invests in biopharmaceutical, specialty pharmaceutical, medical device, diagnostics and enabling life science technology companies globally, which he joined in 2018. Prior to joining Bain Capital, Dr. Downing was a resident physician at the Brigham and Women’s Hospital in Boston, where he cared for patients on the inpatient medical service and in the outpatient clinic. Throughout his medical career, Dr. Downing has been an active health policy researcher and is the author of more than 40 articles in peer-reviewed scientific literature. Prior to his medical career, Dr. Downing was a consultant at McKinsey and Company where he worked with clients in the pharmaceutical, hospital and financial services industries on a wide range of strategic problems. Dr. Downing graduated from Harvard College magna cum laude with a degree in chemistry. He received an M.D. cum laude from Yale University School of Medicine.
We believe that Dr. Downing’s medical experience, as well as his experience investing and serving on the boards of life science companies provide Dr. Downing with the qualifications and skills to serve on the Board of Directors.
Dr. Louis Lange . Louis Lange, M.D., Ph.D., has served as a member of the Board of Directors since November 2022. Dr. Lange previously served on the NewAmsterdam Pharma board from 2021 to November 2022. Dr. Lange previously served as the chief of cardiology and a professor of medicine at the Washington University School of Medicine and was one of the early academicians in molecular cardiology. Dr. Lange founded and served as the chief executive officer and chairman of CV Therapeutics, Inc. (Nasdaq: CVTX) from 1990 until 2019, and as a senior advisor to Gilead Sciences, Inc. from 2009 until 2019, following its acquisition of CV Therapeutics. Dr. Lange currently serves as a general partner with Asset Management Ventures. Dr. Lange also serves on the board of directors of Stealth Biotherapeutics Corp. (private), BioPlus Acquisition Corp. (Nasdaq: BIOS), Amygdala Neurosciences, Inc. and Recardia, Inc. Dr. Lange previously served on the board of directors of Audentes Therapeutics, Inc. (sold to Astellas Pharma Inc.), CymaBay Therapeutics (announced acquisition by Gilead) and Epiphany Tech Acquisition Corp., (Nasdaq: EPHY). Dr. Lange has a Bachelor’s degree from the University of Rochester, an M.D. from Harvard University and a Ph.D. in Biological Chemistry, also from Harvard University.
We believe that Dr. Lange’s board experience, medical background and experience as a public company officer, provide Dr. Lange with the qualifications and skills to serve on the Board of Directors.
Sander Slootweg . Sander Slootweg has served as a member of the Board of Directors since November 2022. Mr. Slootweg previously served on the NewAmsterdam Pharma board from 2020 until November 2022. Mr. Slootweg co-founded Forbion and has served as managing partner since 2006. Mr. Slootweg currently serves on the boards of several of Forbion’s portfolio companies including, Replimune Group Inc., NorthSea Therapeutics B.V., Azafaros B.V., Xention, Oxyrane Belgium NV and Forbion European Acquisition Corporation (Nasdaq: FRBN). Mr. Slootweg was responsible for several substantial exits: Forbion’s major position in Argenx SE (Nasdaq: ARGX), Dezima’s acquisition by Amgen in 2015 for up to $1.55 billion and the sale of Biovex Group, Inc. to Amgen in 2011 for up to $1 billion. Mr. Slootweg has previously served on the boards of Pulmagen Therapeutics, Fovea Pharmaceuticals SA (sold to Sanofi-aventis in 2009), uniQure N.V. (IPO on Nasdaq in 2014), Argenta Limited (sold to Galapagos NV in 2010), Alantos Pharmaceuticals, Inc. (sold to Amgen in 2007), Impella CardioSystems AG (sold to Abiomed Inc. in 2005), Pieris Pharmaceuticals, Inc. (IPO on Nasdaq in 2015). Before co-founding Forbion, Mr. Slootweg was an
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investment director at ABN AMRO Capital Life Sciences. Mr. Slootweg holds degrees in business and financial economics from the Free University of Amsterdam and business administration from Nijenrode University, The Netherlands.
We believe that Mr. Slootweg’s experience investing in and serving on multiple boards of life science companies, provide Mr. Slootweg with the qualifications and skills to serve on the Board of Directors.
John W. Smither . John Smither has served as a member of the Board of Directors since January 2023. Mr. Smither previously served as the Chief Financial Officer of Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) from May 2019 until March 2021, and again as Interim Chief Financial Officer from September 2023 to the present, and the Chief Financial Officer of Sienna Biopharmaceuticals, Inc. (Nasdaq: SNNA) from April 2018 until March 2019. Mr. Smither also served as the interim Chief Financial Officer at Kite Pharma (a Gilead Sciences, Inc. company) from October 2017 until April 2018 during its integration with Gilead. Mr. Smither presently serves on the board of directors of Genelux serving as chair of its compensation committee and as a member of its audit committee. Mr. Smither also served on the board of directors and audit committee chair of eFFECTOR Therapeutics, Inc. (Nasdaq: EFTR) from March 2018 to September 2023 and Applied Molecular Transport, Inc. (Nasdaq: AMTI) from January 2022 to December 2023. Mr. Smither also served as a member of the nomination and corporate governance committee of eFFECTOR Therapeutics and the compensation committee of Applied Molecular Transport. Mr. Smither previously served on the board of directors of Achaogen, Inc. and Principia Biopharma Inc and as the chair of their audit committees. Mr. Smither also has 15 years’ experience as a practicing CPA (inactive), including time spent as an audit partner with Ernst & Young LLP.
We believe that Mr. Smither’s experience as the Chief Financial Officer for a number of public companies and his experience serving on the board of directors and audit committees of other public life science companies provide Mr. Smither with the qualifications and skills to serve on the Board of Directors.
Dr. James N. Topper . James N. Topper, M.D., Ph.D., has served as a member of the Board of Directors since November 2022. Dr. Topper previously served as FLAC’s Chief Executive Officer and Chairman of the FLAC Board of Directors from October 2020 until November 2022. Dr. Topper currently serves as a Managing Partner of Frazier Life Sciences (“Frazier”). He joined Frazier in 2003 and opened Frazier’s Menlo Park office in the same year. Throughout his tenure as a Managing Partner, Dr. Topper has invested across over 35 companies encompassing a broad spectrum of life science and biopharmaceutical companies. Dr. Topper has led and served as a board member for many of Frazier’s successful life sciences investments, including Acerta Pharma BV (sold to AstraZeneca), Amunix Pharmaceuticals, Inc. (sold to Sanofi), Aptinyx Inc. (Nasdaq: APTX), Calistoga Pharmaceuticals, Inc. (co-founder, sold to Gilead Sciences), Entasis Therapeutics Holdings Inc. (sold to Innoviva), Frazier Lifesciences Acquisition Corporation, Mavupharma (sold to AbbVie), Rempex (sold to The Medicines Company), Incline (co-founder, sold to The Medicines Company), Alnara (sold to Lilly), Portola, Inc. (co-founder, Nasdaq: PTLA), Phathom Pharmaceuticals Inc. (Nasdaq: PHAT), CoTherix, Inc (sold to Actelion), and Threshold Pharmaceutical, Inc. (Nasdaq: THLD). He currently represents Frazier on the boards of Alpine Immune Sciences (Nasdaq: ALPN), Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), Lassen Therapeutics, Seraxis Holdings, Inc., Enlaza Therapeutics, Inc., Attovia Therapeutics, Inc., Architect Therapeutics and Serum Detect, Inc. In 2011 and 2016, Dr. Topper was named to the Midas List of leading venture capitalists, and in 2013, Dr. Topper was recognized by Forbes as a top ten healthcare investor. Dr. Topper received his M.D. and Ph.D. in Biophysics from Stanford and his B.S. from the University of Michigan.
We believe that Dr. Topper’s experience overseeing Frazier’s investments in biotechnology, his experience in senior management positions and his significant knowledge of industry, medical and scientific matters, provide Dr. Topper with the qualifications and skills to serve on the Board of Directors.
Janneke van der Kamp . Janneke van der Kamp has served as a member of the Board of Directors since April 2023. Ms. van der Kamp currently serves as the Chief Commercial Officer of Grünenthal and previously spent two decades in roles of increasing responsibility at Novartis, ultimately serving on the Pharma Executive Committee as Global Head of Product & Portfolio Strategy and then Head of Pharma Region Europe from January 2017 until January 2022. While at Novartis, Ms. van der Kamp supported the launch of Novartis’ key cardiovascular disease medicines, as well as the company’s efforts in immunology, dermatology, neuroscience, ophthalmology, and respiratory disease. Ms. van der Kamp received her M.S. in chemistry from Utrecht University and M.B.A. from INSEAD.
We believe that Ms. van der Kamp’s operational experience in the pharmaceutical industry and business development experience provide Ms. van der Kamp that qualifications and skills to serve on the Board of Directors.
Arrangements and Understandings
Drs. Topper and Downing were designated to serve on the Board of Directors by FLAC, and Dr. Davidson, Dr. Kastelein, Dr. Lange, Ms. Audet and Mr. Slootweg were initially designated by NewAmsterdam Pharma pursuant to the terms of the Business Combination Agreement.
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Our Executive Officers
The following table sets forth certain information concerning our executive officers as of February 28, 2024.
Name
Position(s)
Age
Michael Davidson, M.D.
Chief Executive Officer
67
John Kastelein, M.D., Ph.D. FESC
Chief Scientific Officer
70
Douglas Kling
Chief Operating Officer
50
Louise Kooij
Chief Accounting Officer
48
Ian Somaiya
Chief Financial Officer
50
Dr. Michael Davidson . Dr. Davidson’s biography is included in the section above titled “—The Board of Directors.”
Dr. John Kastelein . Dr. Kastelein’s biography is included in the section above titled “—The Board of Directors.”
Douglas Kling . Douglas Kling joined the Company in March 2021 as its Chief Operating Officer. Prior to joining NewAmsterdam Pharma, Mr. Kling served as the Senior Vice President of Clinical Development at Corvidia Therapeutics, Inc. from December 2017 until February 2021. From March 2015 until November 2017, Mr. Kling served as the Senior Vice President, Clinical Development at Matinas BioPharma Holdings, Inc. Mr. Kling earned a B.S. from Duke University and an M.B.A. from Rutgers Business School.
Louise Kooij . Louise Kooij joined the Company as its Chief Financial Officer in May 2020. In January 2023, Ms. Kooij was appointed as the Company’s Chief Accounting Officer and served in that role until March 2023 when she was appointed Interim Chief Financial Officer. In October 2023 Ms. Kooij was appointed as the Company's Chief Accounting Officer. Ms. Kooij previously spent 14 years working in various finance roles at Genzyme Europe B.V., a multinational biotechnology company. Since May 2020, Ms. Kooij has also served as an independent consultant in the role of chief financial officer to other private biotechnology start-ups. From January 2016 to April 2018, Ms. Kooij led Genzyme’s business operations team in Europe and from April 2018 until May 2020, served as the head of Genzyme’s rare disease unit in central and eastern Europe. Ms. Kooij received a master’s degree from Nyenrode Business University and her auditing degree from Hogeschool Markus Verbeek.
Ian Somaiya . Ian Somaiya joined the Company in October 2023 as its Chief Financial Officer. Mr. Somaiya has over 25 years of experience in finance and biotechnology. Most recently, Mr. Somaiya served as the Chief Financial and Business Officer at Elucida Oncology, Inc. from November 2021 until July 2023, were he was responsible for fundraising and overall corporate strategy. From April 2018 until November 2021, Mr. Somaiya served as the Chief Financial Officer of TCR 2 Therapeutics, Inc. (“TCR2”) where he successfully navigated the company through its initial public offering and two follow-on equity financings, raising more than $350 million in the aggregate. During his tenure at TCR2, Mr. Somaiya led the company’s finance and public company reporting functions, as well as the business development and investor relations functions. Prior to joining TCR2, Mr. Somaiya spent over 20 years on Wall Street where he conducted extensive research on more than 100 biotechnology companies across diverse therapeutic areas, technology platforms and stages of development. Mr. Somaiya served as a Managing Director and Head of Biotechnology Research at BMO Capital Markets and served as a Managing Director and Equity Analyst at Nomura Securities Co. Ltd., Piper Jaffray Companies and Thomas Weisel Partners Group, Inc. Mr. Somaiya began his career as a research analyst at Morgan Stanley and Prudential Securities and was recognized as “Best on the Street” by the Wall Street Journal for his coverage on biotechnology in 2006, 2007 and 2008. Mr. Somaiya received a Bachelor of Arts degree in biology and neuroscience from New York university.
Family Relationships
There are no family relationships among any of our executive officers or directors.
Code of Business Conduct and Ethics
We have adopted a code of business conduct and ethics which outlines the principles of legal and ethical business conduct under which we will do business. The code of business conduct and ethics includes a provision that provides for a process by which employees and directors can report potential irregularities. The code of business conduct and ethics also provides protection from retaliation or discrimination by the Company against whistleblowers due to reporting issues relating to compliance with applicable laws and regulations. This code applies to all of our employees, officers and directors. Our code of business conduct and ethics is available on our website at https://ir.newamsterdampharma.com/corporate-governance/governance-overview . Our website and its contents are not incorporated into this annual report.
Director Nomination Process
Qualified candidates will be considered without regard to race, color, religion, sex, ancestry, national origin or disability. The nomination and corporate governance committee does not have a formal policy with respect to director candidates recommended by shareholders but may consider candidates it deems qualified from any source. The Board of Directors believes retaining the flexibility to consider a director candidate or ignore a director candidate if it determines doing so is in the best interest of the Company. If the nomination and corporate
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governance committee approves a candidate for further review they will establish an interview process for the candidate. The nomination and corporate governance committee will also take into consideration the candidate’s personal attributes, including, without limitation, personal integrity, loyalty, ability to apply sound and independent business judgment, awareness of a director’s vital part in our good corporate citizenship and image, time available for meetings and consultation on our matters and willingness to assume broad, fiduciary responsibility.
Audit Committee
The Audit Committee consists of Louis Lange, M.D., Ph.D., John W. Smither and William H. Lewis. Mr. Smither serves as chairperson of the Audit Committee. The Audit Committee assists the Board of Directors in, among other things:
• overseeing the Company’s accounting, financial reporting and internal controls processes;
• overseeing the Company’s compliance with legal and regulatory requirement, including related to cybersecurity and compliance with the code of business conduct and ethics;
• overseeing the selection, qualifications, independence, and performance of the Company’s independent registered public accounting firm; and
• pre-approving of all permitted non-audit services to be performed by the independent registered public accounting firm.
The Audit Committee has the authority to retain independent counsel and advisors to assist in carrying out its responsibilities.
Each member of the Audit Committee is an “independent director,” as such term is defined in Nasdaq Rule 5605(a)(2) and meets the criteria for independence set forth in Rule 10A-3(b)(1) under the Exchange Act. The Board of Directors has also determined that each of the Audit Committee members is able to read and understand fundamental financial statements and that at least one member of the Audit Committee has past employment experience in finance or accounting. The Board of Directors has determined that Dr. Lange qualifies as an “audit committee financial expert,” as such term is defined in the rules of the SEC.
Item 11. Executive Compensation
Summary Compensation Table
The following table sets forth information regarding compensation awarded to or earned by our named executive officers.
Name and Principal Position
Year
Salary ($)
Bonus ($)
Option Awards
($) (1)
Total ($)
Michael Davidson, M.D.
2023
569,000
313,000
4,923,558
5,832,558
Chief Executive Officer (2)
John Kastelein, M.D., Ph.D. FESC
2023
459,346 (3)
218,412
2,300,813
2,978,571
Chief Scientific Officer (4)
Ian Somaiya
2023
90,576
40,000
3,422,493
3,553,069
Chief Financial Officer (5)
(1) Represents the aggregate fair value of awards on the date they were granted in accordance with ASC Topic 718. See the Notes to the Consolidated Financial Statements included herein for the assumptions used to calculate grant date fair value.
(2) In addition to serving as the Chief Executive Officer, Dr. Davidson serves as a member of the Board of Directors. Dr. Davidson receives additional compensation in the amount of €3,600 annually for such service.
(3) In addition to serving as the Chief Executive Officer, Dr. Kastelein serves as a member of the Board of Directors. Dr. Kastelein does not receive additional compensation for such service.
(4) Dr. Kastelein is paid his salary and bonus in Euros. The table above presents Dr. Kastelein’s compensation converted into USD at a rate of $1.0812 per Euro, which was the average exchange rate as published by the European Central Bank for 2023.
(5) Mr. Somaiya joined the Company as Chief Financial Officer in October 2023 and his compensation included in the table above represents his pro rated cash compensation and initial equity award.
Narrative to the Summary Compensation Table
We maintain a compensation policy consistent with Dutch law. Our compensation policy was adopted by the shareholders prior to the closing of the Business Combination. Changes to the compensation policy will require a vote of the shareholders by simple majority of votes cast. The Board of Directors and the compensation committee determine the compensation of individual executive officers with due observance of the compensation policy to the extent applicable.
Base Salary
Our named executive officers receive a base salary to compensate them for services rendered to our company. The base salary payable to each named executive officer is intended to provide a fixed component of compensation reflecting the executive’s skill set, experience, role and
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responsibilities. The 2023 base salaries for our named executive officers are set forth in the table below, as well as the increased base salaries approved in December 2023.
Name
2023 Base Salary ($)
2024 Base Salary ($)
Percent Increase (%)
Michael Davidson, M.D.
$
569,000
$
621,300
9.2
John Kastelein, M.D., Ph.D. FESC (1)
$
459,346
$
485,507
5.7
Ian Somaiya
$
90,576 (2)
$
468,000
4.0
(1) Dr. Kastelein is paid his salary and bonus in Euros. The table above presents Dr. Kastelein’s compensation converted into USD at a rate of $1.0812 per Euro, which was the average exchange rate as published by the European Central Bank for 2023.
(2) Mr. Somaiya’s salary in 2023 was prorated to reflect the fact that he joined the Company as Chief Financial Officer in October 2023.
Equity Compensation
Stock Options
Our named executive officers have been granted options to purchase our Ordinary Shares. The options we have granted to our executive officers are typically subject to time-based vesting and either vest (i) as to 25% of the Ordinary Shares underlying the option on the first anniversary of the grant date and thereafter in substantially equal monthly installments for an additional three years or (ii) in substantially equal monthly installments over four years, in each case, provided the executive officer remains employed with us as of the applicable vesting dates. Vesting rights generally cease upon termination of employment and exercise rights cease shortly after termination, except that exercisability is extended in the case of death or disability. In the event of a change of control, the compensation committee will determine whether the equity incentive awards that replaced the existing options were of equivalent value, the options will be cancelled and holders will continue holding the awards for which the options were replaced. If outstanding options are not replaced by another form of equity incentive award, or are replaced by awards that the compensation committee determines are not of sufficient value, then vesting may be fully accelerated upon a change of control. Prior to the exercise of an option, the holder has no rights as a shareholder with respect to the shares subject to such option, including no voting rights and no right to receive dividends or dividend equivalents.
Employment Agreements and Change of Control Agreements
We have the following employment agreements in place with our named executive officers.
Employment Agreement with Michael Davidson, M.D .
We entered into an employment agreement with Dr. Davidson, our Chief Executive Officer, on January 25, 2023 (the “Davidson Agreement”). Pursuant to the Davidson Agreement, Dr. Davidson is entitled to an annual base salary of $569,000, subject to change as determined by the Company and the Compensation Committee. Dr. Davidson is eligible to receive an annual performance bonus in cash targeted at 50% of his base salary, at our discretion and subject to Dr. Davidson’s continued employment through the payment date of such bonus. In the event Dr. Davidson’s employment is terminated by the Company without Cause (as defined in the Davidson Agreement) or by him for Good Reason (as defined in the Davidson Agreement), we would be required, subject to customary conditions, to pay Dr. Davidson, in addition to certain Accrued Obligations (as defined in the Davidson Agreement), an amount equal to 12 months of his base salary, any bonus earned or payable and a prorated bonus for the calendar year in which the termination occurred, and premium reimbursement equal to the monthly employer contribution that the Company would have made to provide health coverage under the Consolidated Omnibus Budget Reconciliation Act for a maximum of 12 months (“COBRA Premium Reimbursement”). Dr. Davidson will receive only the Accrued Obligations and not be eligible for further compensation if his employment ends for reasons other than termination by the Company without Cause or termination by him for Good Reason.
Dr. Davidson is also eligible to participate in our equity incentive plans, including the Company’s long-term incentive plan (the “LTIP”), and other employee benefits and insurance programs generally made available to our full-time U.S.-based executives.
In the event Dr. Davidson’s employment is terminated by the Company without Cause or by Dr. Davidson for Good Reason (if termination is requested by a third party) within three months prior to a Change in Control (as defined in the Davidson Agreement) or during the 12 months following such Change in Control, Dr. Davidson will be entitled to receive the severance payments and benefits described above. In addition, all of Dr. Davidson’s time-based stock options and equity awards will accelerate, becoming fully exercisable and nonforfeitable as of the termination date and the exercise period for certain vested options will be extended.
Dr. Davidson is also party to a Confidentiality and Assignment of Inventions Agreement, which includes certain customary non-competition, non-solicitation, confidentiality and assignment of inventions obligations in favor of the Company.
Employment of Agreement with John Kastelein, M.D., Ph.D. FESC.
We entered into an employment agreement with Dr. Kastelein, our Chief Scientific Officer, dated November 18, 2022 (the “Kastelein Agreement”). Pursuant to the Kastelein Agreement, Dr. Kastelein is entitled to an annual base salary of approximately $425,000. Dr. Kastelein is eligible to receive an annual performance bonus in cash targeted at 40% of his base salary, at our discretion and subject to Dr. Kastelein’s
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continued employment through the payment date of such bonus. In the event Dr. Kastelein’s employment is terminated by the Company without Cause (as defined in the Kastelein Agreement), we would be required, subject to customary conditions, to pay Dr. Kastelein an amount equal to 12 months of his base salary.
Dr. Kastelein is also eligible to participate in our equity incentive plans, including the LTIP, and other employee benefits and insurance programs offered by us.
In the event Dr. Kastelein’s employment is terminated by the Company without Cause or by Dr. Kastelein for Good Reason (if termination is requested by a third party) within three months prior to a Change in Control (as defined in the Kastelein Agreement) or during 12 months following such Change in Control, Dr. Kastelein will be entitled to receive the severance payments and benefits described above. In addition, all of Dr. Kastelein’s time-based stock options and equity awards will accelerate, becoming fully exercisable and nonforfeitable as of the termination date and the exercise period for certain vested options will be extended.
Dr. Kastelein is also party to a Confidentiality and Assignment of Inventions Agreement, which includes certain customary non-competition, non-solicitation, confidentiality and assignment of inventions obligations in favor of the Company.
Employment of Agreement with Ian Somaiya
We entered into an employment agreement with Mr. Somaiya, our Chief Financial Officer, dated October 6, 2023 (the “Somaiya Agreement”). Pursuant to the Somaiya Agreement, Mr. Somaiya is entitled to an annual base salary of $450,000, subject to change as determined by the Company and the Compensation Committee. Mr. Somaiya is eligible to receive an annual performance bonus in cash targeted at 45% of his base salary, at our discretion and subject to Mr. Somaiya’s continued employment through the payment date of such bonus. In the event Mr. Somaiya’s employment is terminated by the Company without Cause (as defined in the Somaiya Agreement) or by him for Good Reason (as defined in the Somaiya Agreement), we would be required, subject to customary conditions, to pay Mr. Somaiya, in addition to certain Accrued Obligations (as defined in the Somaiya Agreement), an amount equal to 12 months of his base salary, any bonus earned or payable and a prorated bonus for the calendar year in which the termination occurred, and COBRA Premium Reimbursement. Mr. Somaiya will receive only the Accrued Obligations and not be eligible for further compensation if his employment ends for reasons other than termination by the Company without Cause or termination by him for Good Reason.
The Somaiya Agreement provided for the initial grant of 824,697 options to purchase ordinary shares, with 25% vesting on the first anniversary of the grant date and with the remaining shares vesting in equal monthly installments thereafter for three years. Mr. Somaiya is also eligible to participate in our equity incentive plans, including the LTIP, and other employee benefits and insurance programs generally made available to our full-time U.S.-based executives.
In the event Mr. Somaiya’s employment is terminated by the Company without Cause or by Mr. Somaiya for Good Reason (if termination is requested by a third party) within three months prior to a Change in Control (as defined in the Somaiya Agreement) or during the 12 months following such Change in Control, Mr. Somaiya will be entitled to receive the severance payments and benefits described above. In addition, all of Mr. Somaiya’s time-based stock options and equity awards will accelerate, becoming fully exercisable and nonforfeitable as of the termination date and the exercise period for certain vested options will be extended.
Mr. Somaiya is also party to a Confidentiality and Assignment of Inventions Agreement, which includes certain customary non-competition, non-solicitation, confidentiality and assignment of inventions obligations in favor of the Company.
Outstanding Equity Awards at 2023 Fiscal Year-End
The following table sets forth information regarding option awards held as of December 31, 2023 by our named executive officers.
Option Awards
Number of Securities Underlying Unexercised Options
Name
Grant Date
Exercisable (#)
Unexercisable (#)
Option Exercise Price ($/Sh)
Option Expiration Date
Michael Davidson, M.D.
11/22/2022
824,398
164,869
1.28613 (1)
7/6/2031
11/22/2022
660,985
1,779,553
10.00
11/22/2032
1/1/2023
-
1,021,485
10.90
1/1/2033
John Kastelein, M.D., Ph.D. FESC
11/22/2022
1,153,616
18,286
1.28613 (1)
7/6/2031
11/22/2022
263,185
708,541
10.00
11/22/2032
1/1/2023
-
477,347
10.90
1/1/2033
Ian Somaiya
11/1/2023
-
824,697
9.26
11/1/2033
(1) The exercise price of the option is Euro 1.16392 and has been converted into USD in the table above at a rate of $1.1050 per Euro, which was the exchange rate as of December 29, 2023 as published by European Central Bank.
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Equity Incentive Plans
LTIP
We have established our LTIP, under which we may grant options, restricted shares, restricted share units, share appreciation rights and other equity and equity-based awards. As of December 31, 2023 the total number of Ordinary Shares underlying awards granted under the LTIP (other than awards granted as Earnout RSUs in accordance with the Business Combination Agreements or as replacement awards in connection with a merger or business combination) will not exceed 13,649,090; provided that the number of Ordinary Shares reserved for grant under the LTIP will increase annually on January 1 of each calendar year by 5% of the-then issued and outstanding Ordinary Shares or such lower number as may be determined by the Board of Directors.
The LTIP is administered by the Board of Directors and the compensation committee. The Board of Directors has delegated authority to grant awards under the LTIP to the compensation committee for awards to eligible participants not then serving on the compensation committee. The Board of Directors has also delegated the authority to grant awards under the LTIP to non-executive officers or directors to Dr. Davidson who will determine when to grant equity awards and the terms of such awards. We may grant awards under the LTIP to our directors, employees, consultants or other advisors. The Board of Directors or the compensation committee may condition awards under the LTIP upon the achievement or satisfaction of performance criteria and/or continued service with the company and determines the vesting conditions for awards under the LTIP. The LTIP includes provisions for good leavers and bad leavers as well as for changes in control.
Rollover Option Plan
We also established a rollover option plan (the “Rollover Plan”) in connection with the closing of the Business Combination, under which we assumed the outstanding options of certain optionholders of NewAmsterdam Pharma Holding B.V. who held their options through entities in exchange for a grant of options to acquire Ordinary Shares. The total number of Ordinary Shares underlying the options covered by the Rollover Plan is 1,736,545. Any Ordinary Shares underlying options granted under the Rollover Plan that are forfeited, canceled or otherwise terminated will become available for issuance under the LTIP.
The Rollover Plan is administered by the Board of Directors and the compensation committee. The Rollover Plan includes provisions applicable in the event of a change of control.
Supplementary LTIP
We have also established our supplementary long-term incentive plan (the “Supplementary LTIP”), under which we may grant options, restricted shares, restricted share units, share appreciation rights and other equity and equity-based awards to our employees and consultants (but not our directors). The total number of Ordinary Shares underlying awards that may be granted under the Supplementary LTIP (other than awards granted as replacement awards in connection with a merger or business combination) will not exceed 1,040,233.
The Supplementary LTIP is administered by the Board of Directors and the compensation committee. The Board of Directors has delegated authority to grant awards under the Supplementary LTIP to the compensation committee for awards to anyone not then serving on the compensation committee. The Board of Directors has also delegated the authority to grant awards under the Supplementary LTIP to non-executive officers or directors to Dr. Davidson, who will determine when to grant equity awards and the terms of such awards. The awards issued under the Supplementary LTIP will have terms substantially similar to those issued under the LTIP. The Supplementary LTIP includes provisions applicable in the event of a change of control.
Limitation of Liability and Indemnification
Under Dutch law, our directors may be held liable for damages in the event of improper or negligent performance of their duties. They may be held liable for damages to the Company and to third parties for infringement of the Articles of Association or of certain provisions of Dutch law. In certain circumstances, they may also incur other specific civil, administrative and criminal liabilities. Subject to certain exceptions, the Articles of Association provide for indemnification of our current and former directors and other current and former officers and employees as designated by the Board of Directors. No indemnification under the Articles of Association will be given to an indemnified person:
• if a competent court or arbitral tribunal has established, without having (or no longer having) the possibility for appeal, that the acts or omissions of such indemnified person that led to the financial losses, damages, expenses, suit, claim, action or legal proceedings as described above are of an unlawful nature (including acts or omissions which are considered to constitute malice, gross negligence, intentional recklessness and/or serious culpability attributable to such indemnified person);
• to the extent that his or her financial losses, damages and expenses are covered under insurance and the relevant insurer has settled, or has provided reimbursement for, these financial losses, damages and expenses (or has irrevocably undertaken to do so);
• in relation to proceedings brought by such indemnified person against us, except for proceedings brought to enforce indemnification to which he or she is entitled pursuant to the Articles of Association, pursuant to an agreement between such indemnified person and us, which has been approved by us or pursuant to insurance taken out by us for the benefit of such indemnified person; and
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• for any financial losses, damages or expenses incurred in connection with a settlement of any proceedings effected without our prior consent.
Under the Articles of Association, the Board of Directors may stipulate additional terms, conditions and restrictions in relation to the indemnification described above.
We have also entered into indemnification agreements with each of our directors and executive officers providing for procedures for indemnification and advancements by us of certain expenses and costs relating to claims, suits or proceedings arising from his or her service to us or, at our request, service to other entities, as officers or directors to the maximum extent permitted by Dutch law and subject to the exceptions provided in such agreements.
Compensation Committee Interlocks and Insider Participation
The compensation committee consists of Louis Lange, M.D., Ph.D., John W. Smither, Janneke van der Kamp and William H. Lewis. All members of the compensation committee are independent directors, and none of our executive officers or former executive officers served on the compensation committee or on the board of any company that employed any member of the compensation committee or the Board of Directors during the year ended December 31, 2023.
Director Compensation
Director Compensation
The Board of Directors and the compensation committee determine the compensation of individual directors in accordance with our compensation policy to the extent applicable. All non-employee directors are paid an annual retainer of $40,000. Non-employee directors may receive further compensation ranging from $5,000 to $15,000 for serving as chair or member of committees (i.e. Audit Committee or Compensation Committee). We have also granted and expect to continue granting, certain non-employee directors, other than those affiliated with our significant shareholders, options to purchase Ordinary Shares as compensation for their service on the Board of Directors.
Director Service Agreement
We entered into services agreements with all of our directors which regulate their services as our directors. These services agreements, except for James N. Topper’s services agreement, contain non-competition and non-solicitation arrangements, as well as a requirement to assign and transfer to us any intellectual and industrial property rights originating from the director’s services as a director or inventor for us, but do not provide for compensation.
Director Indemnification Agreements
The Articles of Association require us to indemnify our current and former directors to the fullest extent permitted by law, subject to certain exceptions. We entered into indemnification agreements with all of our directors providing for procedures for indemnification and advancements by us of certain expenses and costs relating to claims, suits or proceedings arising from their service to us or, at our request, service to other entities, as directors or officers to the maximum extent permitted by law.
Director Compensation Table
The following table sets forth information regarding the compensation earned for service on the Board of Directors by our non-employee directors during the year ended December 31, 2023. We reimburse members of the Board of Directors for reasonable travel and out-of-pocket expenses incurred in connection with attending Board and committee meetings.
Name
Fees Earned or Paid in Cash ($)
Option Awards ($) (1)
Total ($)
Non-Employee Directors
Juliette Audet
45,625
-
45,625
Nicholas S. Downing M.D.
47,333
-
47,333
Louis Lange, M.D., Ph.D.
61,500
277,550
339,050
William H. Lewis, J.D., M.B.A.
-
-
-
Sander Slootweg
48,000
-
48,000
John W. Smither
56,250
82,584
138,834
Janneke van der Kamp
31,875
102,780
134,655
James N. Topper, M.D., Ph.D.
40,000
-
40,000
(1) Represents the aggregate fair value of awards on the date they were granted in accordance with ASC Topic 718. See the Notes to the Consolidated Financial Statements included herein for the assumptions used to calculate grant date fair value.
(2) Compensation information for Dr. Michael Davidson and Dr. John Kastelein is included in the section titled “ Executive Compensation—Summary Compensation Table .”
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Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Securities Authorized For Issuance Under Equity Compensation Plans
Our LTIP and Rollover Plan are our only equity compensation plans approved by our shareholders. The Supplementary LTIP was approved by the Board of Directors but was not approved by our shareholders. The following table sets forth certain information as of December 31, 2023 with respect to our LTIP, Rollover Plan and Supplementary LTIP:
Plan Category
Number of Securities to be Issued Upon Exercise of Outstanding Options (A)
Weighted-Average Exercise Price of Outstanding Options (B)
Number of Securities Remaining Available for Future Issuance Under Equity Compensation Plans (Excluding Securities Reflected in Column (A)) (C)
Equity compensation plans approved by shareholders:
15,044,495
$
7.84
180,893
LTIP (1)
13,371,872
$
8.65
116,971
Rollover Plan
1,672,623
$
1.28613 (3)
63,922
Equity compensation plans not approved by shareholders:
Supplementary LTIP (2)
739,014
$
10.90
301,219
Total:
15,783,509
$
7.98
482,112
(1) The number of Ordinary Shares reserved for grant under the LTIP will increase annually on January 1 of each calendar year by 5% of the then issued and outstanding Ordinary Shares or such lower number as may be determined by the Board of Directors.
(2) See the section titled “ Executive Compensation—Equity Incentive Plans ” and Note 9 in the financial statements included herein for a brief description of the terms of the Supplementary LTIP.
(3) The exercise price of the options included in the Rollover Plan is Euro 1.16392 and has been converted into USD in the table above at a rate of $1.1050 per Euro, which was the exchange rate as of December 29, 2023 as published by European Central Bank.
Security Ownership of Certain Beneficial Owners and Management
The following table sets forth information regarding the actual beneficial ownership of Ordinary Shares as of February 16, 2024, by:
• each person, or group of affiliated persons, known by the Company to beneficially own more than 5% of outstanding Ordinary Shares;
• each of our executive officers or directors; and
• all of our executive officers and directors, as a group.
The SEC has defined “beneficial ownership” of a security to mean the possession, directly or indirectly, of voting power and/or investment power over such security. A shareholder is also deemed to be, as of any date, the beneficial owner of all securities that such shareholder has the right to acquire within 60 days after that date through (i) the exercise of any option, warrant or right, (ii) the conversion of a security, (iii) the power to revoke a trust, discretionary account or similar arrangement, or (iv) the automatic termination of a trust, discretionary account or similar arrangement. In computing the number of shares beneficially owned by a person and the percentage ownership of that person, Ordinary Shares subject to options or other rights (as set forth above) held by that person that are currently exercisable, or will become exercisable within 60 days thereafter, are deemed outstanding, while such shares are not deemed outstanding for purposes of computing percentage ownership of any other person. Each person named in the table has sole voting and investment power with respect to all of the Ordinary Shares shown as beneficially owned by such person, except as otherwise indicated in the table or footnotes below.
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The beneficial ownership of Ordinary Shares is based on 89,266,673 Ordinary Shares issued and outstanding, as of February 16, 2024. Unless otherwise indicated, we believe that all persons named in the table below have sole voting and investment power with respect to all Ordinary Shares beneficially owned by them. To our knowledge, no Ordinary Shares beneficially owned by any executive officer, director or director nominee have been pledged as security. None of our shareholders has different voting rights from other shareholders.
Number of Shares Beneficially Owned
Percentage of Ordinary Shares Beneficially Owned (%)
Name of Beneficial Owner
Shares
%
Named Executive Officers, Directors and Director Nominees
Michael Davidson, M.D. (1)
2,948,135
3.23%
John Kastelein, M.D., Ph.D. FESC (2)
1,699,981
1.87%
Ian Somaiya
—
—
William H. Lewis, J.D., M.B.A.
—
—
Juliette Audet (3)
—
—
Nicholas Downing, M.D. (4)
—
—
Louis Lange, M.D., Ph.D. (5)
179,489
*
Sander Slootweg (6)
—
—
John W. Smither (7)
5,814
*
James N. Topper, M.D., Ph.D. (8)
12,632,038
14.07%
Janneke van der Kamp
—
—
All executive officers and directors as a group (13 persons)
18,571,798
19.58%
Number of Shares Beneficially Owned
Percentage of Ordinary Shares Beneficially Owned (%)
Name of Beneficial Owner
Shares
%
Other 5% Shareholders
Entities affiliated with Forbion (9)
11,831,461
13.25%
Saga Investments Coöperatief U.A. (10)
4,910,000
5.50%
Frazier Lifesciences Sponsor LLC and affiliates (11)
12,632,038
14.07%
Entities affiliated with Bain Capital Life Sciences Investors, LLC (12)
10,473,913
11.72%
RA Capital Healthcare Fund, L.P. (13)
8,197,333
9.15%
Viking Global Investors LP (14)
8,024,565
8.99%
* Indicates beneficial ownership of less than 1% of total outstanding Ordinary Shares.
(1) Consists of (i) 199,784 Ordinary Shares, (ii) options to purchase 2,039,572 Ordinary Shares, exercisable within 60 days of February 16, 2024, (iii) Warrants to purchase 100,000 Ordinary Shares, exercisable within 60 days of February 16, 2024 and (iv) 608,779 Ordinary Shares subject to forfeiture underlying depositary receipts issued by Stichting Administratiekantoor EPNAP (“STAK EPNAP”). STAK EPNAP has sole voting and investment power over the securities described in (iv) while underlying the depositary receipts and are presented here because the depositary receipts can be cancelled by the board of directors of STAK EPNAP at any time as a consequence of which the shareholder will become the beneficial owner of the securities underlying the depositary receipts.
(2) Consists of (i) options to purchase 1,226,889 Ordinary Shares held by Futurum B.V. through PoolCo and (ii) options to purchase 473,640 Ordinary Shares held by Dr. Kastelein directly, each exercisable within 60 days of February 16, 2024.
(3) See Note 9. Ms. Audet is a member of the Board of Directors and is a member of the investment committee of Forbion IV but does not have beneficial ownership of the securities beneficially owned by Forbion IV referenced in Note 9.
(4) Does not include Ordinary Shares held by the Bain Capital Life Sciences Entities (as defined below). Dr. Downing serves as a Managing Director of Bain Capital Life Sciences Investors, LLC.
(5) Consists of (i) 24,878 Ordinary Shares (ii) Warrants to purchase 44,619 Ordinary Shares, exercisable within 60 days of February 16, 2024 and (iii) options to purchase 109,992 Ordinary Shares, exercisable within 60 days of February 16, 2024.
(6) See Note 9. Mr. Slootweg is a member of the Board of Directors and is a partner of each of Forbion IV Management and Growth Management and a member of the investment committees of each of Forbion IV and Forbion Growth, and a member of the board of directors of ForGrowth, but does not have beneficial ownership of the securities referenced in Note 9.
(7) Consists of options to purchase 5,814 Ordinary Shares, exercisable within 60 days of February 16, 2024.
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(8) Consists of the shares described in Note 11. Dr. Topper disclaims beneficial ownership of the shares referenced in Note 11, except to the extent of his pecuniary interest therein, if any.
(9) Consists of (i) 6,635,391 Ordinary Shares beneficially owned by Forbion Capital Fund IV Coöperatief U.A. (“Forbion IV”) through ForGrowth NAP B.V. (“ForGrowth”) that are held directly by NAP PoolCo B.V. (“PoolCo”), (ii) 4,543,897 Ordinary Shares beneficially owned by Forbion Growth Opportunities Fund I Coöperatief U.A. (“Forbion Growth”) through ForGrowth that are held directly by PoolCo and (iii) 652,173 Ordinary Shares held directly by ForGrowth. ForGrowth is a joint-investment vehicle wholly owned by Forbion IV and Forbion Growth. PoolCo is a Dutch limited liability company that holds Ordinary Shares on behalf of its shareholders. The governing documents of PoolCo vest voting and investment control over the Ordinary Shares held by PoolCo in PoolCo’s shareholders and, as a result, PoolCo disclaims beneficial ownership of such Ordinary Shares. The information herein is based solely on the Form 3 filed by the holders on January 2, 2024. The address for the Forbion entities is Gooimeer 2-35, 1411 DC Naarden, the Netherlands.
Forbion IV Management B.V. (“Forbion IV Management”) may be deemed to have voting and dispositive power over the Ordinary Shares beneficially owned by Forbion IV. Investment decisions with respect to the Ordinary Shares held by Forbion IV are made by its investment committee which may delegate such powers to the authorized representatives of Forbion IV Management. Mssrs. Slootweg, van Osch, Mulder, van Houten, van Deventer, Reithinger, Kersten and Boorsma are partners of Forbion IV Management, which is the director of and acts as the investment advisor to Forbion IV. Mr. Slootweg is a member of the Board of Directors and is a partner of Forbion IV Management and a member of the investment committee of Forbion IV.
Forbion Growth Management B.V. (“Growth Management”) may be deemed to have voting and dispositive power over the Ordinary Shares beneficially owned by Forbion Growth. Investment decisions with respect to the Ordinary Shares held by Forbion Growth are made by its investment committee which may delegate such powers to the authorized representatives of Growth Management. Mssrs. Slootweg, van Osch, Mulder, van Houten, van Deventer, Reithinger, Kersten, Joustra, Bos en Lüneborg and Boorsma are partners of Growth Management, which is the director of and acts as the investment advisor to Forbion Growth. Mr. Slootweg is a member of the Board of Directors and is a partner of Growth Management and a member of the investment committee of Forbion Growth.
(10) Amgen Singapore Manufacturing Pte. Ltd. (“Amgen Singapore”) is the sole shareholder of Saga Investments Coöperatief U.A. Amgen Technology, Limited (“Amgen Technology”) is the sole shareholder of Amgen Singapore and Onyx Pharmaceuticals, Inc. (“Onyx”) and Amgen Inc. are the shareholders of Amgen Technology. As a result, Amgen Singapore, Amgen Technology Onyx and Amgen Inc. may each be deemed to share beneficial ownership of the Ordinary Shares held of record by Saga Investments Coöperatief U.A. The business address is Minervum 7061, 4817 ZK Breda, The Netherlands. The information herein is based solely on the Schedule 13G filed by the Saga Investments Coöperatief U.A., Amgen Singapore, Amgen Technology, Onyx and Amgen on December 2, 2022.
(11) Consists of 3,801,000 Ordinary Shares and Warrants to purchase 167,000 Ordinary Shares held by Frazier Lifesciences Sponsor LLC (the “Sponsor”). The sole member of the Sponsor is Frazier Life Sciences X, L.P. (“FLS X”). FHMLS X, L.P. is the general partner of FLS X and FHMLS X, L.L.C. is the general partner of FHMLS X, L.P. Patrick J. Heron and James N. Topper are the members of FHMLS X, L.L.C. and managers of each of FLS X, FHMLS X, L.P. and FHMLS X, L.L.C.
Also included in the total number are (i) 3,000,000 Ordinary Shares and Warrants to purchase 333,333 Ordinary Shares held by FLS X, (ii) 1,043,495 Ordinary Shares held by Frazier Life Sciences XI, L.P. (“FLS XI”), (iii) 2,293,412 Ordinary Shares held by Frazier Life Sciences Public Fund, L.P. (“FLSPF”) and (iv) 1,993,798 Ordinary Shares held by Frazier Life Sciences Overage Fund, L.P. (“FLSOF”). FHMLS XI, L.P. is the general partner of FLS XI and FHMLS XI, L.L.C. is the general partner of FHMLS XI, L.P. Patrick J. Heron, Dan Estes and James N. Topper are the members of FHMLS XI, L.L.C. and managers of each of FLS XI, FHMLS XI, L.P. and FHMLS XI, L.L.C. FHMLSP, L.P. is the general partner of FLSPF and FHMLSP, L.L.C. is the general partner of FHMLSP, L.P. Patrick J. Heron, James N. Topper, Albert Cha and James Brush are the members of FHMLSP, L.L.C. and managers of each of FLSPF, FHMLSP, L.P. and FHMLSP, L.L.C. FHMLSP Overage, L.P., is the general partner of FLSOF and FHMLSP Overage, L.L.C. is the general partner of FHMLSP Overage, L.P. Patrick J. Heron, James N. Topper, Albert Cha and James Brush are the members of FHMLSP Overage, L.L.C. and managers of each of FLSOF, FHMLSP Overage, L.P. and FHMLSP Overage, L.L.C. The information herein is based on the Schedule 13D/A filed by Sponsor, FLS X, FLS XI, FLSPF, FLSOF, FHMLS X, L.P., FHMLS X, L.L.C., FHMLS XI, L.P., FHMLS XI, L.L.C., FHMLSP, L.P., FHMLSP, L.L.C., FHMLSP Overage, L.P., FHMLSP Overage, L.L.C., Mr. Cha, Mr. Brush, Mr. Heron, Mr. Estes and Mr. James Topper on February 21, 2024. The address of these holders is Two Union Square, 601 Union St., Suite 3200, Seattle, WA 98101.
(12) Consists of (i) 4,797,557 Ordinary Shares held by BCLS II Investco, LP (“BCLS II Investco”), (ii) 5,376,356 Ordinary Shares held by BCLS Fund III Investments, LP (“BCLS Fund III”), (iii) 267,429 Ordinary Shares and Warrants to purchase 89,143 Ordinary Shares held by Bain Capital Life Sciences Fund II, L.P. (“BCLS Fund II”) and (iv) 32,571 Ordinary Shares and Warrants to purchase 10,857 Ordinary Shares held by BCIP Life Sciences Associates, LP (“BCIPLS” and, together with BCLS II Investco, BCLS Fund III and BCLS Fund II, the “Bain Capital Life Sciences Entities”). Bain Capital Life Sciences Investors, LLC (“BCLSI”) (a) is the manager of Bain Capital Life Sciences Investors II, LLC, which is the general partner of BCLS Fund II, which is the managing member of BCLS II Investco (GP), LLC, which is the general partner of BCLS II Investco, (b) is the manager of Bain Capital Life Sciences III General Partner, LLC, which is the general partner of Bain Capital Life Sciences Fund III, L.P., which is the managing member of BCLS Fund III Investments GP, LLC, which is the general partner of BCLS Fund III, and (c) governs the investment strategy and decision-making process with respect to
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investments held by BCIPLS. As a result, BCLSI may be deemed to share voting and dispositive power with respect to the securities held by the Bain Capital Life Sciences Entities. The address of the Bain Capital Life Sciences entities is c/o Bain Capital Life Sciences, LP, 200 Clarendon Street, Boston, MA 02116. The information herein is based solely on the Form 3 filed by the Bain Capital Life Sciences Entities on December 29, 2023.
(13) Consists of 7,864,000 Ordinary Shares and Warrants to purchase 333,333 Ordinary Shares held by RA Capital Healthcare Fund, L.P. (“RACHF”). RA Capital Management, L.P. (“RA Capital”) is the investment manager for RACHF. The general partner of RA Capital is RA Capital Management GP, LLC, of which Peter Kolchinsky and Rajeev Shah are the managing members. Each of Mr. Kolchinsky and Mr. Shah may be deemed to have voting and investment power over the Ordinary Shares held by RACHF. Mr. Kolchinsky and Mr. Shah disclaim beneficial ownership of such shares, except to the extent of any pecuniary interest therein. RA Capital serves as investment adviser for RACHF and may be deemed a beneficial owner of the securities described herein as held by RACHF. RACHF has delegated to RA Capital the sole power to vote and the sole power to dispose of all securities held in RACHF’s portfolios, including the Ordinary Shares reported herein. Because RACHF has divested itself of voting and investment power over the reported securities they hold and may not revoke that delegation on less than 61 days’ notice, RACHF disclaims beneficial ownership of the securities they hold. The business address of the persons and entities set forth herein is 200 Berkeley Street, 18 th Floor, Boston, MA 02116. The information herein is based solely on the Schedule 13G/A filed by RACHF, RA Capital, Mr. Kolchinsky and Mr. Shah on February 14, 2024.
(14) Consists of 5,376,459 Ordinary Shares and 2,648,106 Ordinary Shares owned by Viking Global Opportunities Illiquid Investments Sub-Master LP (“VGOP”) and Viking Global Opportunities Drawdown (Aggregator) LP (“VGOD”), respectively. Viking Global Investors LP (“VGI”) provides managerial services to VGOP and VGOD and has the authority to dispose of and vote the Ordinary Shares that VGOP and VGOD directly own to and as a result may be deemed to beneficially own the Ordinary Shares that VGOP and VGOD directly. Viking Global Opportunities Parent GP LLC (“Opportunities Parent”) is the sole member of Viking Global Opportunities GP LLC (“Opportunities GP”), which has the authority to dispose of and vote the Ordinary Shares controlled by Viking Global Opportunities Portfolio GP LLC (“Opportunities Portfolio GP”) (which consists of the Ordinary Shares that VGOP directly owns) and is the sole member of Viking Global Opportunities Drawdown GP LLC (“VGOD GP”), which has the authority to dispose of and vote the Ordinary Shares controlled by Viking Global Opportunities Drawdown Portfolio GP LLC (“VGOD Portfolio GP”) (which consists of the Ordinary Shares that VGOD directly owns). Opportunities Parent does not directly own any Ordinary Shares. Opportunities GP serves as the sole member of Opportunities Portfolio GP and has the authority to dispose of and vote the Ordinary Shares controlled by Opportunities Portfolio GP. Opportunities Portfolio GP serves as the general partner of VGOP and has the authority to dispose of and vote the Ordinary Shares that VGOP directly owns. VGOD GP serves as the sole member of VGOD Portfolio GP and has the authority to dispose of and vote the Ordinary Shares controlled by VGOD Portfolio GP. VGOD Portfolio GP serves as the general partner of VGOD and has the authority to dispose of and vote the Ordinary Shares that VGOD directly owns. O. Andreas Halvorsen, David C. Ott and Rose S. Shabet, as Executive Committee Members of Viking Global Partners LLC (general partner of VGI) and Opportunities Parent, have shared authority to dispose of and vote the Ordinary Shares beneficially owned by VGI and Opportunities Parent. None of Mr. Halvorsen, Mr. Ott and Ms. Shabet directly owns any Ordinary Shares. Each of Mr. Halvorsen, Mr. Ott and Ms. Shabet may be deemed to beneficially own the Ordinary Shares that VGOP and VGOD directly own. The business address of the persons and entities set forth herein is 55 Railroad Avenue, Greenwich, Connecticut 06830. The information herein is based solely on the Schedule 13G/A filed by VGI, Opportunities Parent, Opportunities GP, Opportunities Portfolio GP, VGOP, VGOD GP, VGOD Portfolio GP, VGOD, Mr. Halvorsen, Mr. Ott and Ms. Shabet on February 14, 2024.
Item 13. Certain Relationships and Related Transactions, and Director Independence
Independence of the Board of Directors
The nomination and corporate governance committee and Board of Directors have undertaken a review of the independence of our directors and considered whether any director has a relationship that, in the opinion of such committee or the Board of Directors, would interfere with the exercise of independent judgment in carrying out the responsibilities of a member of the Board of Directors. Based upon information requested from and provided by each director concerning such director’s background, employment and affiliations, including family relationships, the Board of Directors has determined that all of our directors, other than Dr. Davidson and Dr. Kastelein are “independent directors,” as such term is defined in Nasdaq Rule 5605(a)(2). In making these determinations, the Board of Directors considered the current and prior relationships that each director has with the Company and all other facts and circumstances that the Board of Directors deemed relevant in determining their independence, including the beneficial ownership of our capital stock by each director.
Certain Relationships and Related Transactions
Review, Approval or Ratification of Transactions with Related Persons
We adopted a related party transaction policy that requires the review and, if applicable, approval or ratification of any related party transaction by the Board of Directors, the Audit Committee or another designated committee consisting solely of independent directors. Our Audit Committee will review this related party transaction policy periodically and will recommend changes to the Board of Directors as appropriate.
121
In addition, under Dutch law and the Articles of Association, our directors may not take part in any discussion or decision-making that involves a subject or transaction in relation to which he or she has a direct or indirect personal conflict of interest with us. Such a conflict of interest would generally arise if the director concerned is unable to serve our interests and the business connected with us with the required level of integrity and objectivity due to the existence of the conflicting personal interest. The Articles of Association provide that if as a result of conflicts of interests no resolution of the Board of Directors can be adopted, the resolution may nonetheless be adopted by the Board of Directors as if none of our directors had a conflict of interest. In that latter case, each of our director is entitled to participate in the discussion and decision-making process and to cast a vote.
A related party transaction is generally any transaction in which the Company or its subsidiaries is or will be a participant, in which the amount involved exceeds $120,000, and a director (or nominee), executive officer, immediate family member, or any beneficial owner of more than 5% of our Ordinary Shares, has or will have a direct or indirect material interest.
Certain Related Party Transactions
Investor Rights Agreement
In connection with the closing of the Business Combination, we entered into the Investor Rights Agreement, dated November 22, 2022 (the “Investor Rights Agreement”), with the Sponsor and the former FLAC directors (the “FLAC Initial Shareholders”), and certain NewAmsterdam Pharma shareholders agreed not to sell, assign, offer to sell, contract, pledge, grant, or otherwise dispose of or enter into any swap or other similar arrangement, with respect to the Ordinary Shares such persons received in connection with the Business Combination for six months from the date the Domestication became effective (the “Final Closing Date”), subject to certain limited exceptions. In addition, the FLAC Initial Shareholders agreed not to sell, assign, offer to sell, contract, pledge, grant, or otherwise dispose of or enter into any swap or other similar arrangement, with respect to the Ordinary Shares they received in connection with the Business Combination for a period beginning on the Final Closing Date and ending one year after the Final Closing Date. Notwithstanding the foregoing, the restrictions above ended with respect to the Ordinary Shares held by the NewAmsterdam Pharma shareholders and 50% of the Ordinary Shares held by the FLAC Initial Shareholders, as the case may be, received in connection with the Business Combination, on May 22, 2023 according to the terms of the Investor Rights Agreement. The restrictions on the remaining 50% of the Ordinary Shares of the FLAC Initial Shareholders, received in connection with the Business Combination, ended on November 23, 2023, one year after the Final Closing Date. An aggregate of 44,914,642 Ordinary Shares held by former NewAmsterdam Pharma shareholders (including Amgen and MTPC) had registration rights pursuant to the terms of the Investor Rights Agreement.
In June 2023, certain of our selling securityholders (the “Selling Securityholders”) exercised their right pursuant to the Investor Rights Agreement to demand an underwritten shelf takedown of Ordinary Shares. On June 6, 2023, the Company and certain of the Selling Securityholders, including affiliates of Forbion, entered into an Underwriting Agreement (the “Underwriting Agreement”) with Jefferies LLC and SVB Securities LLC, as representatives of the several underwriters named therein (the “Underwriters”). The Underwriting Agreement related to an underwritten public offering of 13,857,415 Ordinary Shares by those certain Selling Securityholders at a public offering price of $11.50 per Ordinary Share (the “Secondary Offering”). In connection with the Secondary Offering, certain of the participating Selling Securityholders granted the Underwriters a 30-day option to purchase an additional 2,078,612 Ordinary Shares at the public offering price, less underwriting discounts and commissions, which option was partially exercised for 1,930,280 additional Ordinary Shares in connection with the closing of the Secondary Offering. The Company did not sell any Ordinary Shares in the Secondary Offering and did not receive any proceeds from the Secondary Offering.
Indemnification Agreements
The Articles of Association provide for certain indemnification rights for our current and former directors and other current and former officers and employees as designated by the Board of Directors (the “Indemnified Persons”). Specifically, we indemnify the Indemnified Persons against any financial losses or damages and any expense reasonably paid or incurred in connection with any threatened, pending or completed suit, to the extent these relate to such Indemnified Persons’ current or former position with the Company as permitted by applicable law.
We have also entered into indemnification agreements with each of our directors and executive officers providing for procedures for indemnification and advancements by us of certain expenses and costs relating to claims, suits or proceedings arising from his or her service to us or, at our request, service to other entities, as officers or directors to the maximum extent permitted by Dutch law and subject to the exceptions provided in such agreements.
Employment Agreements
See the section titled “ Executive Compensation—Employment Agreements and Change of Control Agreements ” above for a further discussion of these arrangements.
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Item 14. Principal Accountant Fees and Services
Principal Accountant Fees and Services
The following table presents the aggregate fees billed by Deloitte Accountants B.V. for the years ended December 31, 2023 and 2022.
For the Years Ended December 31,
(In thousands of USD)
2023
2022
Audit Fees
1,525
2,027
Audit-Related Fees
—
—
Tax Fees
—
—
All Other Fees
—
—
Total Fees
1,525
2,027
Audit fees include the standard audit work performed each fiscal year necessary to allow the auditor to issue an opinion on our financial statements and to issue an opinion on the local statutory financial statements. Audit fees also include services such as reviews of quarterly financial results and review of securities offering documents.
Audit-related fees consisted of fees billed for assurance and related services that were reasonably related to the performance of the audit or review of our financial statements or for services that were traditionally performed by the external auditor.
Tax fees are fees billed for professional services for tax compliance, tax advice and tax planning.
Audit Committee Pre-Approval Policies
The Audit Committee evaluates the qualifications, independence and performance of the independent auditor as well as pre-approves and reviews the engagement and the provision of all audit and non-audit services to be performed by the independent auditor. In accordance with this policy, all services performed by and fees paid to Deloitte Accountants B.V. were pre-approved by the Audit Committee.
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PART IV
Item 15. Exhibits, Financial Statement Schedules
(1) Financial Statements:
The Financial Statements required to be filed by Item 8 of this Annual Report, and filed in this Item 15, are as follows:
Page
Report of Independent Registered Public Accounting Firm (Deloitte Accountants B.V.; PCAOB ID: 1243)
F- 2
Consolidated Balance Sheets as at December 31, 2023 and 2022
F-3
Consolidated Statements of Operations and Comprehensive Income (Loss) for the Years Ended December 31, 2023, 2022 and 2021
F-4
Consolidated Statements of Mezzanine Equity and Shareholders' Equity (Deficit) for the Years Ended December 31, 2023, 2022 and 2021
F-5
Consolidated Statements of Cash Flows for the Years Ended December 31, 2023, 2022 and 2021
F-6
Notes to Consolidated Financial Statements
F-7
(2) Financial Statement Schedules:
Schedules are omitted because they are not applicable, or are not required, or because the information is included in the financial statements and notes thereto.
(3) Exhibits:
Exhibit No.
Description of Document
2.1
Business Combination Agreement, dated as of July 25, 2022, by and among Frazier Lifesciences Acquisition Corporation, NewAmsterdam Pharma Holding B.V., NewAmsterdam Pharma Company B.V. and NewAmsterdam Pharma Investment Corporation (incorporated by reference to Annex A to the Registration Statement on Form F-4 (File No. 333-266510), filed with the SEC on October 13, 2022).
2.2
Plan of Merger (incorporated by reference to Annex B to the Registration Statement on Form F-4 (File No. 333-266510), filed with the SEC on October 13, 2022).
3.1
English translation of the Deed of Conversion and Articles of Association of NewAmsterdam Pharma Company N.V. (incorporated by reference to Exhibit 1.1 to the Shell Company Report on Form 20-F (File No. 001-41562), filed with the SEC on November 28, 2022).
4.1
Warrant Assignment, Assumption and Amendment Agreement, among Continental Stock Transfer & Trust Company, NewAmsterdam Pharma Company B.V. and Frazier Lifesciences Acquisition Corporation (incorporated by reference to Exhibit 4.1 to the Registration Statement on Form F-4 (File No. 333-266510), filed with the SEC on October 13, 2022).
4.2
Warrant Agreement, between Frazier Lifesciences Acquisition Corporation and Continental Stock Transfer & Trust Company (incorporated by reference to Exhibit 4.4 to the Registration Statement on Form S-1 (File No. 333-250858), filed by Frazier Lifesciences Acquisition Corporation with the SEC on November 20, 2020).
4.3
Warrant Certificate of NewAmsterdam Pharma Company N.V (incorporated by reference to Exhibit 4.2 to the Registration Statement on Form F-4 (File No. 333-266510), filed with the SEC on October 13, 2022).
4.4
Description of Share Capital and Articles of Association.
10.1
Form of Subscription Agreement (incorporated by reference to Annex C to the Registration Statement on Form F-4 (File No. 333-266510), filed with the SEC on October 13, 2022).
10.2
Investor Rights Agreement, dated November 22, 2022, by and among NewAmsterdam Pharma Company N.V. and certain of its shareholders (incorporated by reference to Exhibit 10.5 to the Registration Statement on Form F-1 (File No. 333-268888), filed with the SEC on January 17, 2023).
10.3+
Form of Director & Officer Indemnity Agreement (incorporated by reference to Exhibit 10.7 to the Registration Statement on Form F-4 (File No. 333-266510), filed with the SEC on October 13, 2022).
10.4+
NewAmsterdam Pharma Company N.V. Long-term Incentive Plan.
10.5+
NewAmsterdam Pharma Company N.V. Rollover Option Plan (incorporated by reference to Exhibit 4.16 to the Shell Company Report on Form 20-F (File No. 001-41562), filed with the SEC on November 28, 2022).
10.6+
NewAmsterdam Pharma Company N.V. Supplementary Long-term Incentive Plan (incorporated by reference to Exhibit 10.15 to the Registration Statement on Form F-1 (File No. 333-268888), filed with the SEC on January 17, 2023).
10.7+
Employment Agreement, dated January 25, 2023, between NewAmsterdam Pharma Corporation and Michael Davidson.
10.8+
Employment Agreement, dated November 18, 2022, between NewAmsterdam Pharma B.V. and John Kastelein.
10.9+
Employment Agreement, dated October 6, 2023, between NewAmsterdam Pharma Corporation and Ian Somaiya.
10.10+
Form of Option Award Agreement
124
21.1
List of Subsidiaries (incorporated by reference to Exhibit 21.1 to the Registration Statement on Form F-1 (File No. 333-268888), filed with the SEC on January 17, 2023).
23.1
Consent of Deloitte Accountant B.V., independent registered public accounting firm.
24.1
Power of Attorney (incorporated by reference to the signature page of this Annual Report on Form 10-K).
31.1
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
97.1
Policy Relating to Recovery of Erroneously Awarded Compensation of NewAmsterdam Pharma Company N.V.
101.INS
Inline XBRL Instance Document
101.SCH
Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents
104
Cover Page Interactive Data File-the cover page interactive data is embedded within the Inline XBRL document or included within the Exhibit 101 attachments
+ Indicates management contract or compensatory plan.
Portions of this document (indicated by “[***]”) have been omitted because such information is not material and is the type of information that the Registrant treats as private or confidential.
Item 16. Form 10-K Summary
None.
125
SIGN ATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
NewAmsterdam Pharma Company N.V.
Date: February 28, 2024
By:
/s/ Michael Davidson
Michael Davidson, M.D.
Chief Executive Officer and Director
(Principal Executive Officer)
Date: February 28, 2024
By:
/s/ Ian Somaiya
Ian Somaiya
Chief Financial Officer
(Principal Financial Officer)
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Michael Davidson and Ian Somaiya, jointly and severally, as his or her true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution, for him or her, and in his or her name, place and stead, in any and all capacities, to sign any and all amendments to this report, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents full power and authority to do and perform each and every act and thing requisite or necessary to be done in and about the premises hereby ratifying and confirming all that said attorneys-in-fact and agents, or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
126
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Signature
Title
Date
/s/ Michael Davidson
Dr. Michael Davidson
Chief Executive Officer and Director (Principal Executive Officer)
February 28, 2024
/s/ Ian Somaiya
Ian Somaiya
Chief Financial Officer (Principal Financial Officer)
February 28, 2024
/s/ Louise Kooij
Louise Kooij
Chief Accounting Officer ( Principal Accounting Officer )
February 28, 2024
/s/ William H. Lewis
William H. Lewis
Chair and Director
February 28, 2024
/s/ Juliette Audet
Juliette Audet
Director
February 28, 2024
/s/ Nicholas S. Downing
Dr. Nicholas S. Downing
Director
February 28, 2024
/s/ John Kastelein
Dr. John Kastelein
Chief Scientific Officer, Director
February 28, 2024
/s/ Louis Lange
Dr. Louis Lange
Director
February 28, 2024
/s/ Sander Slootweg
Sander Slootweg
Director
February 28, 2024
/s/ John W. Smither
John W. Smither
Director
February 28, 2024
/s/ James N. Topper
Dr. James N. Topper
Director
February 28, 2024
/s/ Janneke van der Kamp
Janneke van der Kamp
Director
February 28, 2024
127
NewAmsterdam Pharma Company N.V.
Index to Financial Statements
Page
Report of Independent Registered Public Accounting Firm (Deloitte Accountants B.V.; PCAOB ID: 1243 )
F- 2
Consolidated Balance Sheets as at December 31, 2023 and 2022
F- 3
Consolidated Statements of Operations and Comprehensive Income (Loss) for the Years Ended December 31, 2023, 2022 and 2021
F- 4
Consolidated Statements of Mezzanine Equity and Shareholders' Equity (Deficit) for the Years Ended December 31, 2023, 2022 and 2021
F- 5
Consolidated Statements of Cash Flows for the Years Ended December 31, 2023, 2022 and 2021
F- 6
Notes to Consolidated Financial Statements
F- 7
F- 1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the shareholders and the Board of Directors of NewAmsterdam Pharma Company N.V.
Opinion on the Financial Statements
We have audited the accompanying Consolidated Balance Sheets of NewAmsterdam Pharma Company N.V. and subsidiaries (the "Company") as of December 31, 2023 and 2022, the related Consolidated Statements of Operations and Comprehensive Income (Loss), Mezzanine Equity and Shareholders’ Equity (Deficit) and Cash Flows, for each of the three years in the period ended December 31, 2023, and the related notes (collectively referred to as the "financial statements"). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2023, in conformity with accounting principles generally accepted in the United States of America.
Change in Reporting Framework
As discussed in Note 2 to the financial statements, the Company has changed its reporting framework from International Financial Reporting Standards as issued by the International Accounting Standards Board to accounting principles generally accepted in the United States for all periods presented.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ Deloitte Accountants B.V .
Eindhoven, The Netherlands
February 28, 2024
We have served as the Company's auditor since 2020.
F- 2
NewAmsterdam Pharma Company N.V.
Consolidated Balance Sheets
As at December 31,
2023
2022
(In thousands of USD)
Assets
Current assets:
Cash
340,450
467,728
Prepayments and other receivables
6,341
10,251
Total current assets
346,791
477,979
Property, plant and equipment, net
46
34
Operating right of use asset
55
120
Intangible assets
170
208
Long term prepaid expenses
35
156
Total assets
347,097
478,497
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable
16,923
11,853
Accrued expenses and other current liabilities
11,398
6,117
Deferred revenue, current
8,942
13,874
Lease liability, current
60
66
Derivative warrant liabilities
12,574
4,147
Total current liabilities
49,897
36,057
Deferred revenue, net of current portion
1,019
4,792
Lease liability, net of current portion
-
60
Derivative earnout liability
7,788
7,522
Total liabilities
58,704
48,431
Commitments and contingencies (Note 13)
Shareholders' Equity (deficit):
Ordinary shares, € 0.12 par value; 400,000,000 shares authorized; 82,469,768 and 81,559,780 shares issued and outstanding at December 31, 2023 and 2022, respectively
10,173
10,055
Additional paid-in capital
590,771
555,625
Accumulated loss
( 316,973
)
( 140,036
)
Accumulated other comprehensive income (loss)
4,422
4,422
Total shareholders' equity
288,393
430,066
Total liabilities and shareholders' equity (deficit)
347,097
478,497
See notes to consolidated financial statements.
F- 3
NewAmsterdam Pharma Company N.V.
Consolidated Statements of Operations and Comprehensive Income (Loss)
For the year ended December 31,
2023
2022
2021
(In thousands of USD, except per share amounts)
Revenue
14,090
102,694
—
Operating expenses:
Research and development expenses
159,424
86,744
28,974
Selling, general and administrative expenses
37,633
19,507
6,003
Total operating expenses
197,057
106,251
34,977
Operating loss
( 182,967
)
( 3,557
)
( 34,977
)
Other income (expense):
Interest income
11,283
—
—
Interest expense
—
( 287
)
( 411
)
Loss on debt extinguishment
—
—
( 883
)
Fair value change – earnout and warrants
( 10,284
)
( 1,041
)
—
Fair value change – profit rights
—
( 12,390
)
( 20,613
)
Fair value change – tranche rights
—
4,388
13,393
Foreign exchange gains/(losses)
5,058
( 9,747
)
1,706
Loss before tax
( 176,910
)
( 22,634
)
( 41,785
)
Income tax expense
27
—
—
Loss for the year
( 176,937
)
( 22,634
)
( 41,785
)
Other comprehensive income (loss)
Foreign currency translation adjustments
—
11,126
286
Income tax effects of other comprehensive income (loss)
—
—
—
Total comprehensive income (loss) for the year, net of tax
( 176,937
)
( 11,508
)
( 41,499
)
Net loss per ordinary share
Basic and diluted
$
( 2.15
)
$
( 1.19
)
$
( 3.81
)
See notes to consolidated financial statements.
F- 4
NewAmsterdam Pharma Company N.V.
Consolidated Statements of Mezzanine Equity and Shareholders' Equity (Deficit)
Mezzanine Equity
Shareholders' Equity
(In thousands of USD, except share amounts)
Shares
Amount
Shares
Amount
Additional Paid-In Capital
Accumulated Loss
Cumulative Translation Adjustments
Total Shareholders' Equity
Opening balance at January 1, 2021
-
-
5,000,000
55
2,702
( 68,802
)
( 6,990
)
( 73,035
)
Conversion of convertible debt
1,111,115
12,953
—
—
—
—
—
—
Series A - Tranche I
4,928,613
71,588
—
—
—
—
—
—
Issuance of non-voting shares (CEO Restricted Share Award)
—
—
285,714
3
( 3
)
—
—
—
Share-based compensation
—
—
—
—
718
—
—
718
Total profit or loss and comprehensive loss for the year
—
—
—
—
—
( 41,785
)
286
( 41,499
)
As at December 31, 2021
6,039,728
84,541
5,285,714
58
3,417
( 110,587
)
( 6,704
)
( 113,816
)
Equity contribution (Series A - Tranche II)
5,691,430
90,468
—
—
—
—
—
—
Repayment of loan (CEO Restricted Share Award)
—
—
—
—
747
—
—
747
Elimination of old shares
(NewAmsterdam Pharma shareholders)
( 11,731,158
)
( 175,009
)
( 5,285,714
)
( 58
)
( 4,164
)
—
—
( 4,222
)
Equity contribution (NewAmsterdam Pharma
shareholders)
—
—
36,258,312
4,470
174,761
—
—
179,231
Equity contribution (FLAC shareholders)
—
—
13,185,138
1,625
66,252
—
—
67,877
Equity contribution (PIPE Financing)
—
—
23,460,000
2,892
231,708
—
—
234,600
Equity contribution (Amgen & MTPC shareholders)
—
—
8,656,330
1,068
84,371
—
—
85,439
Transaction costs on issue of shares
—
—
—
—
( 5,794
)
—
—
( 5,794
)
Earnout obligation upon Closing (NewAmsterdam
Pharma shareholders)
—
—
—
—
—
( 6,815
)
—
( 6,815
)
Share-based compensation
—
—
—
—
4,327
—
—
4,327
Total profit or loss and comprehensive loss for the year
—
—
—
—
—
( 22,634
)
11,126
( 11,508
)
As at December 31, 2022
—
-
81,559,780
10,055
555,625
( 140,036
)
4,422
430,066
Exercise of warrants
—
—
749,741
97
10,116
—
—
10,213
Exercise of stock options
—
—
160,247
21
269
—
—
290
Share-based compensation
—
—
—
—
24,761
—
—
24,761
Total profit or loss and comprehensive loss for the year
—
—
—
—
—
( 176,937
)
—
( 176,937
)
As at December 31, 2023
-
-
82,469,768
10,173
590,771
( 316,973
)
4,422
288,393
See notes to consolidated financial statements.
F- 5
NewAmsterdam Pharma Company N.V.
Consolidated Statements of Cash Flows
For the year ended December 31,
2023
2022
2021
(In thousands of USD)
Operating activities:
Loss for the year
( 176,937
)
( 22,634
)
( 41,785
)
Non-cash adjustments to reconcile loss before tax to net cash flows:
Depreciation and amortization
49
9
5
Non-cash rent expense
6
10
2
Amortization of discount on convertible note
—
—
155
Loss on extinguishment of convertible note
—
—
883
Fair value change - tranche rights
—
( 4,388
)
( 13,393
)
Fair value change - IPR&D
—
12,390
20,613
Fair value change - derivative earnout and warrants
10,284
1,041
-
Foreign exchange (gains)/losses
( 5,058
)
9,747
( 1,706
)
Share-based compensation
24,572
4,117
1,244
Changes in working capital:
Changes in prepayments (current and non-current) and other receivables
4,031
( 4,185
)
( 5,232
)
Changes in accounts payable
5,070
4,809
6,558
Changes in accrued expenses and other current liabilities
5,470
( 8,679
)
3,144
Changes in deferred revenue
( 8,705
)
18,428
-
Net cash (used in)/provided by operating activities
( 141,218
)
10,665
( 29,512
)
Investing activities:
Purchase of property, plant and equipment, including internal use software
( 24
)
( 221
)
( 24
)
Net cash used in investing activities
( 24
)
( 221
)
( 24
)
Financing activities:
Proceeds from issuing equity securities (Series A)
—
90,469
84,704
Proceeds from issuing equity securities (FLAC shareholders)
—
71,883
—
Proceeds from issuing equity securities (PIPE Financing)
—
234,600
—
Transaction costs on issue of shares
—
( 5,794
)
—
Proceeds from payment of shareholder loan
—
747
—
Proceeds from exercise of warrants
8,622
—
—
Proceeds from exercise of options
290
—
—
Net cash provided by financing activities
8,912
391,905
84,704
Net change in cash
( 132,330
)
402,349
55,168
Foreign exchange differences
5,052
5,248
( 4,683
)
Cash at the beginning of the year
467,728
60,131
9,646
Cash at the end of the year
340,450
467,728
60,131
Noncash financing and investing activities
Derivative earnout obligation recognized related to the Business Combination (as defined in Note 3)
—
6,815
—
Liabilities assumed in the Business Combination (as defined in Note 3)
—
( 4,006
)
—
Contribution of interest in NewAmsterdam Pharma Holding B.V. by Participating Shareholders (as defined in Note 3)
—
( 179,231
)
—
Issuance of Ordinary Shares to Participating Shareholders (as defined in Note 3)
—
179,231
—
Issuance of Ordinary Shares pursuant to the Profit Right Agreement (as defined in Note 2)
—
85,439
—
Conversion of convertible debt to mezzanine equity
—
—
12,953
Recognition of ROU asset
—
—
196
Supplemental cash flow disclosures
Cash paid for interest
—
277
—
Cash paid for income taxes
27
—
—
See notes to consolidated financial statements
F- 6
NewAmsterdam Pharma Company N.V.
Notes to Consolidated Financial Statements
Note 1. The Company
NewAmsterdam Pharma Company N.V. (“NewAmsterdam Pharma” or the “Company”) is a late-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well-tolerated. The Company was incorporated in the Netherlands as a Dutch private company with limited liability (besloten vennootschap met beperkte aansprakelijkheid) under the name NewAmsterdam Pharma Company B.V. on June 10, 2022. On November 21, 2022, the Company’s corporate form was converted to a Dutch public limited liability company (naamloze vennootschap) and its name was changed to NewAmsterdam Pharma Company N.V. The Company’s ordinary shares, nominal value € 0.12 per share (the "Ordinary Shares") are listed on the Nasdaq Global Market and trade under the symbol “NAMS.”
In November 2022, the Company conducted an internal reorganization for the purpose of participating in the merger of the acquired company, Frazier Lifesciences Acquisition Corporation (“FLAC”) as described in Note 3. As a result of the internal restructuring and merger, NewAmsterdam Pharma Holding B.V., FLAC and NewAmsterdam Pharma Investment Corporation, a new Cayman-based exempted company, became wholly-owned subsidiaries of the Company.
The Company is subject to risks and uncertainties common to early-stage companies in the biopharmaceutical industry, including, but not limited to, development by competitors of more advanced or effective therapies, dependence on key executives, protection of and dependence on intellectual property, compliance with government regulations and ability to secure additional capital to fund operations. Significant additional research and development efforts and regulatory approval will be required prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.
Going Concern
The Company has incurred net operating losses and negative cash flows from operations since its inception and had an accumulated deficit of $ 317.0 million as of December 31, 2023. As of December 31, 2023 the Company had cash of $ 340.5 million. Management believes that the existing financial resources are sufficient to continue operating activities for at least the twelve-month period following the issuance of these consolidated financial statements.
Note 2. Summary of Significant Accounting Policies
Basis of Presentation
The Company’s consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). Any reference in these notes to the applicable guidance is meant to refer to authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board ("FASB"). The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, after elimination of intercompany accounts and transactions.
Prior to 2023, the Company prepared its financial statements in accordance with the International Financial Reporting Standards as issued by the International Accounting Standard Board (“IFRS”) as permitted in the United States based on the Company’s qualification as a foreign private issuer under the rules and regulations of the SEC. In connection with the loss of the Company’s status as a foreign private issuer effective on January 1, 2024, the Company, as a domestic filer, prepared these financial statements in accordance with U.S. GAAP. The transition to U.S. GAAP was made retrospectively for all periods from the Company’s inception.
F- 7
Functional and Reporting Currency
The functional currency of the Company and its subsidiaries has historically been EUR. The Company reassessed its functional currency and determined the United States Dollar (“USD” or “$”) to be the functional currency of the Company and its subsidiaries beginning January 1, 2023. Significant elements involved in the determination of the functional currency change include a shift in the Company’s sources of financing from EUR to USD given its access to the U.S. public market and an increase of operating costs incurred in USD due to Phase III trials taking place predominantly in the United States, among other factors. Given these significant changes, management concluded that the majority of the factors supported the determination of the USD as the functional currency.
Due to the loss of the Company’s status as a foreign private issuer effective on January 1, 2024, the Company, as a domestic filer, changed its reporting currency from EUR to U.S. dollar. The change in reporting currency was applied retrospectively. Financial statements for all periods have been recast into U.S. Dollars.
Consolidation
The consolidated financial statements comprise the financial statements of the Company and its subsidiaries. Subsidiaries are all entities over which the Company has a controlling financial interest either through variable interest or through voting interest. Currently, the Company has no involvement with variable interest entities and all subsidiaries are wholly-owned. Intercompany transactions, balances, income, and expenses are eliminated in consolidation. Profits and losses resulting from intercompany transactions that are recognized in assets are also eliminated.
Use of Estimates
The preparation of the Company’s consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenue and expenses during the reporting period. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, assumptions related to the Company’s revenue recognition, accrual of research and development expenses, valuation of stock option awards and valuation of derivative instruments. The Company based its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates when there are changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. If actual results differ from the Company’s estimates, or to the extent these estimates are adjusted in future periods, the Company’s results of operations could either benefit from, or be adversely affected by, any such change in estimate.
Fair Value Measurements
Certain assets and liabilities of the Company are carried at fair value under U.S. GAAP either upon initial recognition or for subsequent accounting and reporting. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:
• Level 1 – Inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date.
• Level 2 – Valuations based on quoted prices in markets that are not active or for which all significant inputs are observable, either directly or indirectly.
F- 8
• Level 3 – Prices or valuations that require inputs that are both significant to the fair value measurement and unobservable.
If the inputs used to measure the fair value of an asset or a liability fall into different levels of the fair value hierarchy, then the fair value measurement is categorized in its entirety in the same level of the fair value hierarchy as the lowest level input that is significant to the entire measurement.
For assets and liabilities that are recognized in the consolidated financial statements at fair value on a recurring basis, the Company determines whether transfers have occurred between levels in the hierarchy by re-assessing categorization (based on the lowest level input that is significant to the fair value measurement as a whole), at the end of each reporting period.
Segment Information
Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated regularly by the chief operating decision maker in deciding how to allocate resources and in assessing performance. The Company’s chief operating decision maker is the chief executive officer. The Company has one business activity and there are no segment managers who are held accountable for operations, operating results, and plans for levels or components below the consolidated unit level. Accordingly, the Company has one operating segment and, therefore, one reportable segment, which comprises the discovery, development and commercialization of transformative therapies for cardio-metabolic diseases.
Cash
Cash comprises checking and savings deposits. The carrying amount of these assets is approximately equal to their fair value due to their short-term nature. The Company maintains certain deposits which exceed the amounts covered by insurance provided by the government of the country in which the deposits are held. The Company has not experienced any losses related to amounts held in excess of such limits. The Company does not hold any cash equivalents.
Property Plant and Equipment, Net
Property and equipment are stated at cost less accumulated depreciation. Depreciation is calculated using the straight-line method and is recorded in Selling, general, and administrative expense over the estimated useful lives of the assets. Maintenance and repairs that do not improve or extend the lives of the respective assets are expensed as incurred. Upon disposal of an asset, the related cost and accumulated depreciation is removed from the accounts and any resulting gain or loss on the transaction is recognized.
The estimated useful lives of property and equipment are as follows:
Estimated Useful Life (in years)
Computer equipment
5
Office furniture and equipment
5
Impairment of Long-Lived Assets
The Company reviews the recoverability of its long-lived assets when events or changes in circumstances occur that indicate that the carrying value of the asset may not be recoverable. The assessment of possible impairment is based on the ability to recover the carrying value of the assets from the expected future cash flows (undiscounted and without interest expense) of the related operations. If these cash flows are less than the carrying value of such assets, an impairment loss for the difference between the estimated fair value and carrying value is recorded. To date, the Company has not recorded any material impairment losses on long-lived assets.
Leases
In accordance with ASU No. 2016-02, Leases (Topic 842) (“ASU 2016-02” or “ASC 842”), the Company classifies leases at the lease commencement date. At the inception of an arrangement, the Company determines whether the
F- 9
arrangement is or contains a lease based on the circumstances present. Leases with a term greater than one year will be recognized on the consolidated balance sheets as right-of-use assets (“ROU”), lease liabilities, and if applicable, long-term lease liabilities. The Company includes renewal options to extend the lease in the lease term where it is reasonably certain that it will exercise these options. Lease liabilities and the corresponding ROU are recorded based on the present values of lease payments over the terms. The Company determines the discount rate based on the implicit rate in the contract and if not readily determinable, the Company utilizes the appropriate incremental borrowing rates, which are the rates that would be incurred to borrow on a collateralized basis, over similar terms, amounts equal to the lease payments in a similar economic environment. Variable payments that do not depend on a rate or index are not included in the lease liability and are recognized as incurred. Lease contracts do not include residual value guarantees nor do they include restrictions or other covenants. Certain adjustments to ROUs may be required for items such as initial direct costs paid, incentives received, or lease prepayments. If significant events, changes in circumstances, or other events indicate that the lease term or other inputs have changed, the Company would reassess lease classification, remeasure the lease liability using revised inputs as of the reassessment date, and adjust the ROU. Lease agreements with a noncancelable term of less than 12 months and no purchase option that the Company is reasonably certain to exercise are not recorded on the Company’s consolidated balance sheet. Costs related to such lease agreements are operating cash flows and recorded in selling, general and administrative expenses.
Derivative Warrants Liability
The Company accounts for the public warrants and private placement warrants in accordance with the guidance contained in ASC 480, Distinguishing Liabilities from Equity ASC 815-40, Derivatives and Hedging—Contracts in Entity's Own Equity , under which the public warrants and private placement warrants do not meet the criteria for equity treatment and must be recorded as liabilities carried at fair value. This liability is subject to re-measurement at each balance sheet date until exercised, and any change in fair value is recognized as (expense)/income in the consolidated statements of operations and comprehensive loss. The public warrants are valued based on the quoted market price as of each relevant reporting date, which is a Level 1 fair value measurement. The private warrants were initially and subsequently determined to have value equal to the public warrants as the terms of the instruments are substantially equivalent. The valuation of the private warrants is considered to be a Level 2 fair value measurement.
Derivative Earnout Liability
The Company accounts for the Earnout Shares (as defined below) allocated to Participating Shareholders (as defined below) in accordance with the guidance contained in ASC 480, Distinguishing Liabilities from Equity ASC 815-40, Derivatives and Hedging—Contracts in Entity's Own Equity , under which the Earnout Shares allocated to Participating Shareholders do not meet the criteria for equity treatment and must be recorded as liabilities carried at fair value. This liability is subject to re-measurement at each balance sheet date until exercised, and any change in fair value is recognized as (expense)/income in the consolidated statements of operations and comprehensive loss. The liability is valued utilizing the Black-Scholes model, taking into account the probability of achieving the applicable milestone. The valuation of the Earnout Shares allocated to Participating Shareholders is considered to be a Level 3 fair value measurement.
Convertible debt and embedded redemption features
On July 2, 2020, the Company, as borrower, entered into an unsecured convertible loan agreement (the “Convertible Loan Agreement”) which granted the Company up to € 17 million, available over three tranches, with Forbion Capital Fund IV, Forbion Capital Fund II and Michael Davidson.
The Company evaluated each of the embedded redemption features, as defined in the Convertible Loan Agreement, under ASC 815, Derivatives and Hedging , to determine whether they required bifurcation. The Company determined that the redemption features were required to be bifurcated and accounted for separately as derivative financial instruments because they were not clearly and closely related to the host debt instrument.
F- 10
The bifurcation of the embedded derivative liability created a discount to the debt host carried at amortized cost. The discount was accreted to the contractual maturity date using the effective interest rate model. This liability was subject to re-measurement at each balance sheet date until maturity, and any change in fair value recognized as (expense)/income in the consolidated statements of operations and comprehensive loss.
On January 7, 2021, the Company closed a funding round to raise up to € 160 million in equity financing, set to occur in two tranches. As a result, € 11.7 million in outstanding principal and unpaid interest from the convertible debt was extinguished and converted into 1,111,115 Series A preferred shares. Extinguishment accounting was applied with the difference between the value of the convertible debt (including the embedded derivative feature) and the value of the Series A Preferred Shares recorded as (expense)/income in the consolidated statements of operations and comprehensive loss for the year ended December 31, 2021.
Tranche Rights
On December 30, 2020, we entered into the Series A Subscription Agreement to issue Series A Preferred Shares for up to an aggregate amount of € 160 million, occurring in two tranches. The first tranche closed in January 2021 (the “First Closing”). The Series A subscription agreement entitled us to cause the investors to subscribe for the second tranche Series A Preferred Shares upon the occurrence of certain clinical development and business development milestones.
As part of the Series A subscription agreement, investors are entitled to participate in the second tranche earlier, if they elect. This tranche right was determined to be a “freestanding financial instrument” as defined in the ASC Master Glossary because the tranche rights were transferable, and they do not need to be transferred with the related Series A shares. Further, when tranche rights are exercised, Series A shares held by investors remain outstanding. Management assessed the freestanding financial instrument under ASC 480, Distinguishing Liabilities from Equity , and determined that the tranche rights should be accounted for as a liability at fair value and revalued at each reporting period until settlement, with changes in the fair value recorded in the consolidated statements of operations and comprehensive loss. This determination was made because the tranche rights are exercisable at the investor’s election, and therefore future issuance of Series A shares were a contingent event that was not in the Company’s control.
We issued the second tranche of Series A Preferred Shares in February 2022. This exercise of the tranche rights resulted in cash proceeds to the company, derecognition of the tranche right liability, and Series A Preferred Shares recognized at fair value, with the difference recorded to the consolidated statements of operations and comprehensive loss.
Profit rights - Dezima acquisition
On April 9, 2020, the Company entered into a purchase agreement with Saga Investments Coöperatief U.A., an affiliate of Amgen (“Amgen”) (the “2020 SPA”), to acquire all of the outstanding share capital of Dezima, a company whose principal activity was to develop compounds that treat cardiovascular disease related to dyslipidemia. The principal reason for this acquisition was to secure the intellectual property, licensing and know-how of the patented drug Obicetrapib and the in-process research and development (“IPR&D”). The Company paid consideration of € 1 for the IPR&D asset and could potentially make an additional contingent payment depending on future qualifying exit events, if they occurred. In connection with the 2020 SPA, the Company and Amgen entered into a profit right and waiver agreement with Mitsubishi Tanabe Pharma Corporation (“MTPC”) (the “Profit Right Agreement”) in consideration for the waiver of certain rights held by MTPC prior to the Dezima transaction.
The Company evaluates acquisitions of assets and other similar transactions in accordance with ASC 805, Business Combinations, to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If the screen is met, the transaction is accounted for as an asset acquisition. The acquisition of Dezima was accounted for as an asset acquisition because substantially all of the fair value of the gross assets acquired is concentrated in the IPR&D of Obicetrapib. Additionally, the Company determined that as of the acquisition date, the IPR&D did not have an alternative future
F- 11
use by which the economic benefits could be anticipated and estimated. Therefore, it did not meet the definition of an asset and was expensed as incurred.
The aggregate contingent consideration to be paid to Amgen and MTPC would become payable upon a traditional underwritten public offering or an exit event, as defined in the 2020 SPA. These rights were recognized as a contingent consideration liability. Contingent consideration in an asset acquisition is measured and recognized when payment becomes probable and a reliable estimate can be made. Subsequent changes in the accrued amount of contingent consideration are measured and recognized at the end of each reporting period and upon settlement as an adjustment to the cost basis of the acquired asset or group of assets. However, as the acquired asset in the Dezima transaction was IPR&D with no alternative future use, any adjustment to the cost is expensed during the period and not capitalized.
The execution of the Menarini License, in combination with the FLAC Merger, qualified as an exit event pursuant to the 2020 SPA. As a result, on the Closing Date, pursuant to the Profit Right Agreement, Amgen and MTPC each received their respective contingent payments in the form of Ordinary Shares. Immediately prior to the closing of the Business Combination, the value of the financial liability was adjusted to equal the fair value of the Ordinary Shares to be issued to Amgen and MPTC at the closing of the Business Combination with the change in fair value recognized through earnings in the consolidated statement of operations and comprehensive loss. Finally, the liability was derecognized with the corresponding offset to equity to record the issuance of the Ordinary Shares to Amgen and MTPC.
Revenue Recognition
The Company recognizes revenue in accordance with FASB Accounting Standard Update (“ASU”) 2014-09, Revenue from Contracts with Customers , and subsequent amendments (collectively, “ASC 606”).
Under ASC 606, to determine the recognition of revenue, the Company performs the following five steps:
1. identify the contract(s) with the customer;
2. identify the performance obligations in the in the contract;
3. determine the transaction price;
4. allocate the transaction price to the performance obligations in the contract; and
5. recognize revenue when (or as) the Company satisfies a performance obligation.
The Company performs an analysis to identify the performance obligations for its license agreement. Where a license agreement comprises several promises, it must be assessed whether these promises are capable of being distinct within the context of the contract. Promised goods or services are considered distinct when: (i) the customer can benefit from the good or service on its own or together with other readily available resources, and (ii) the promised good or service is separately identifiable from other promises in the contract. In assessing whether promised goods or services are distinct, the Company considers factors such as the stage of development of the underlying intellectual property, the capabilities of the customer to develop the intellectual property on their own and whether the required expertise is readily available. In addition, the Company considers whether the customer can benefit from a promise for its intended purpose without the receipt of the remaining promises, whether the value of the promise is dependent on the unsatisfied promises, whether there are other vendors that could provide the remaining promises, and whether it is separately identifiable from the remaining promises.
The Company estimates the transaction price based on the amount of consideration the Company expects to receive for transferring the promised goods or services in the contract. The consideration may include both fixed consideration and variable consideration. At the inception of each arrangement that includes variable consideration, the Company evaluates the amount of the potential payments and the likelihood that the payments will be received. The Company utilizes either the most likely amount method or expected value method to estimate variable consideration to include in the transaction price based on which method better predicts the amount of consideration
F- 12
expected to be received. The amount included in the transaction price is constrained to the amount for which it is highly probable that a significant reversal of cumulative revenue recognized will not occur. At the end of each subsequent reporting period, the Company re-evaluates the estimated variable consideration included in the transaction price and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis in the period of adjustment.
After the transaction price is determined, it is allocated to the identified performance obligations based on the estimated standalone selling price. The Company must develop assumptions that require judgment to determine the standalone selling price for each performance obligation identified in the contract. The Company utilizes key assumptions to determine the standalone selling price, which may include other comparable transactions, pricing considered in negotiating the transaction, probabilities of technical and regulatory success and the estimated costs. Certain variable consideration is allocated specifically to one or more performance obligations in a contract when the terms of the variable consideration relate to the satisfaction of the performance obligation and the resulting amounts allocated to each performance obligation are consistent with the amounts the Company would expect to receive for each performance obligation.
Revenue is recognized when the customer obtains control of the goods and/or services as provided in the license agreement. The control can be transferred over time or at a point in time – which results in the recognition of revenue over time or at a point in time. The Company recognizes revenue over time as the customer simultaneously receive the benefits provided by the Company’s performance, satisfied over time.
Upfront licensing payments are recognized as revenue at the point in time when the Company transfers control of the license only if the license is determined to be a separate performance obligation from other undelivered performance obligations. Contingent development costs and milestone payments are generally included in the transaction price at the amount stipulated in the respective agreement and recognized to the extent that it is highly probable that a significant reversal in the amount of cumulative revenue recognized will not occur.
The Company will recognize royalty revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied)
Research and Development Expense
Research and development costs are recognized as an expense when incurred and are typically made up of clinical and preclinical activities, drug development and manufacturing costs, and include costs for clinical research organizations and investigative sites. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as information provided by vendors on their actual costs incurred. The determination of the level of services performed by the vendors and the associated expenditure incurred for the services provided is made at each balance sheet date.
Quantification of the research and development expenses incurred during the period requires judgment based on key estimates comprising of non-financial data, because the progress of activities is not directly observable and therefore the precise timing of the research and development activities may not be entirely certain. In estimating progress toward completion of specific tasks, the Company therefore uses non-financial data such as number of patient screenings, patient visits, patient enrollment, clinical site activations and vendor information of actual costs incurred. This data is obtained through reports from outside service providers as to the progress or state of completion of trials or the completion of services and reviewed by Company personnel.
The costs of intangibles that are purchased from others for a particular research and development project and that have no alternative future uses are expensed as research and development costs at the time the costs are incurred or at the time when no alternative future use is identified.
Selling, General and Administrative Expenses
Expenses are recognized on the accrual basis when incurred.
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Personnel Expenses
Wages and salaries, social security contributions, payroll taxes, bonuses, and other employee benefits are recognized on the accrual basis in which the employee provides the associated services.
The Company’s pension plans are classified as defined contribution plans, and, accordingly, no pension obligations are recognized in the balance sheet. Costs relating to defined contribution plans are included in the statement of operations and comprehensive loss in the period in which they are incurred, and outstanding contributions are included in trade and other payables.
Share-Based Compensation
The Company accounts for its share-based compensation in accordance with ASC 178 – Compensation – Stock Compensation. Share-based compensation is measured based on the grant date fair value of the equity awards using the Black-Scholes option pricing model. Share-based compensation expense is recognized on a straight-line basis over the requisite service period of the awards. Forfeitures and modifications are accounted for as they occur. The Company classifies share-based compensation expense in its consolidated statement of operations and comprehensive loss in the same manner in which the award recipient’s salary and related costs are classified.
Net Loss Per Share
Basic net loss per share is calculated by dividing the net loss by the weighted-average number of Ordinary Shares outstanding during the period. Diluted net loss per share is the same as basic net loss per share, since the effects of potentially dilutive securities are antidilutive given the net loss for each period presented.
Income Taxes
The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the consolidated financial statements or in the Company’s tax returns. Deferred tax assets and liabilities are determined on the basis of the differences between the consolidated financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. Potential for recovery of deferred tax assets is evaluated by estimating the future taxable profits expected and considering prudent and feasible tax planning strategies. The Company accounts for uncertainty in income taxes recognized in the consolidated financial statements by applying a two-step process to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more-likely-than-not to be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the consolidated financial statements. The amount of the benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related net interest and penalties.
Foreign Currency and Currency Translation
Monetary assets and liabilities denominated in currencies other than the functional currency are remeasured into the functional currency at exchange rates prevailing at the balance sheet dates. Non-monetary assets and liabilities denominated in foreign currencies are remeasured into the functional currency at the exchange rates prevailing at the date of the transaction. Exchange gains or losses arising from foreign currency transactions are included in the determination of net loss for the respective periods.
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Prior to January 1, 2023 the functional currency of the Company and its subsidiaries was the Euro. The reporting currency of the Company is USD. The Company translated assets and liabilities in prior periods at the exchange rate in effect on the balance sheet date. Revenues and expenses are translated at the exchange rate prevailing at the date of the transaction. Unrealized translation gains and losses are recorded as cumulative translation adjustments which are included in the Company’s balance sheet within accumulated other comprehensive income (loss).
Recently Issued Accounting Pronouncements
In November 2023, the FASB issued ASU 2023-07, "Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures" which requires entities to enhance disclosures around segment reporting. The guidance is effective for annual periods beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the effect this standard will have on its consolidated financial statements and related disclosures.
In December 2023, the FASB issued ASU 2023-09, "Income Taxes (Topic 740): Improvements to Income Tax Disclosures" which requires entities to enhance disclosures around income taxes. The guidance is effective for annual periods beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the effect this standard will have on its consolidated financial statements and related disclosures.
Note 3. FLAC Merger
Prior to November 22, 2022, NewAmsterdam Pharma Company N.V. was a shell company with no active trade or business, and all relevant assets and liabilities, as well as income and expenses, were borne by NewAmsterdam Pharma Holding B.V. FLAC was a special purpose acquisition company (“SPAC”) incorporated on October 7, 2020 as a Cayman Islands exempted company formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or a similar business combination. FLAC completed its initial public offering on December 11, 2020 and listed on the Nasdaq.
On July 25, 2022 , FLAC entered into a Business Combination Agreement (“Business Combination Agreement”) with NewAmsterdam Pharma Holding B.V., the Company, and NewAmsterdam Pharma Investment Corporation, a Cayman Islands exempted company and wholly owned subsidiary of the Company.
On November 22, 2022 (the “Closing Date”), Pursuant to the terms of the Business Combination Agreement, the following transactions occurred (collectively, the “Business Combination”).
• On the date prior to the Closing Date, the shareholders of NewAmsterdam Pharma Holding B.V. (“Participating Shareholders”) exchanged their interest for Ordinary Shares such that the Company became the direct parent of NewAmsterdam Pharma Holding B.V. (the “Exchange”). In connection with the Exchange, 17,016,872 NewAmsterdam Pharma Holding B.V. shares of € 0.01 par value were exchanged at a ratio of approximately 2.13 for 36,258,312 Ordinary Shares, € 0.12 par value per share.
• Immediately after giving effect to the Exchange, a subsidiary of the Company merged with and into FLAC (the “Merger”), with FLAC surviving as a wholly owned subsidiary of the Company.
• Immediately following the Merger, each outstanding warrant to purchase a Class A ordinary share, par value $ 0.0001 per share, of FLAC became a warrant to purchase one Ordinary Share, on the same contractual terms which resulted in the issuance of 167,000 private placement warrants and 4,600,000 public warrants (collectively, the “Warrants”).
• Each NewAmsterdam Pharma Holding B.V. option that was outstanding and unexercised remained outstanding, and to the extent unvested, such option will continue to vest in accordance with its applicable terms, and at the time of the Exchange, such NewAmsterdam Pharma Holding B.V. options became options to purchase, and will when exercised be settled in Ordinary Shares.
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• In addition to the transactions described above, 8,656,330 Ordinary Shares were issued to Saga Investments Coöperatief U.A. (“Amgen”) and Mitsubishi Tanabe Pharma Corporation (“MTPC”) pursuant to their profit rights granted upon the acquisition of Dezima Pharma B.V.
The Business Combination was accounted for as a reverse recapitalization in accordance with U.S. GAAP. Under this method of accounting FLAC was treated as the acquired company for financial reporting purposes. This determination is primarily based on the fact that subsequent to the Business Combination, NewAmsterdam Pharma Holding B.V.'s shareholders had the majority of the voting power of the combined entity, NewAmsterdam Pharma Holding B.V. comprised all of the ongoing operations of the combined entity, NewAmsterdam Pharma Holding B.V.’s shareholders had the ability to appoint a majority of the governing body of the combined entity, and NewAmsterdam Pharma Holding B.V.’s senior management comprised all of the senior management of the combined entity. Accordingly, for accounting purposes, the Business Combination was treated as the equivalent of the Company, immediately following the Exchange, issuing shares for the net assets of FLAC. As of the Closing Date the net assets of FLAC totaled $ 67.9 million which consisted of $ 71.9 million of cash, less liabilities assumed of $ 4.0 million. The Company provided consideration with fair value of $ 130.1 million in the form of Ordinary Shares. The difference between consideration paid and net assets acquired is recorded within additional paid in capital. No goodwill or intangibles were recorded. Operations prior to the Business Combination are those of NewAmsterdam Pharma Holding B.V.
Following the Merger, upon the achievement of a certain clinical development milestone, the Company will issue to the Participating Shareholders, Amgen, MTPC and holders of options to purchase shares of NewAmsterdam Pharma Holding B.V. prior to the closing of the Business Combination, who were directors, officers, employees or consultants of NewAmsterdam Pharma as of the date of the Business Combination Agreement and who are at the time of achievement of such milestone still providing services to the Company (the “Participating Optionholders”), 1,886,137 additional Ordinary Shares (the “Earnout Shares”), which in the case of the Participating Optionholders will take the form of awards of restricted stock units.
The Company raised an additional $ 234.6 million in net equity proceeds through a private placement of Ordinary Shares with existing shareholders of NewAmsterdam Pharma Holding B.V., FLAC and other new investors (the “PIPE Financing”).
Both the Merger and PIPE Financing closed as of November 22, 2022. Upon consummation of the transactions, the Company’s Ordinary Shares began trading on the Nasdaq under the ticker NAMS. The Public Warrants are traded under the ticker NAMSW. The Company also amended existing share-based compensation agreements held by employees of NewAmsterdam Pharma Holding B.V. prior to the Merger in addition to making additional share-based payments.
Note 4. Revenue
On June 23, 2022, NewAmsterdam Pharma Holding B.V. entered into a licensing agreement with A. Menarini International Licensing S.A. (“Menarini”) (the “Menarini License”), pursuant to which it granted Menarini an exclusive, royalty-bearing, sublicensable license under certain of its intellectual property and its regulatory documentation to undertake post approval development activities and commercialize multiple brands of obicetrapib, either as a sole active ingredient product or in a fixed dose combination with ezetimibe (the “Licensed Products”), for any use in the majority of European Countries (“Menarini Territory”).
The Company remains responsible for the development and commercialization costs related to Licensed Products, excluding local development, regulatory and commercialization costs incurred by Menarini in the Menarini Territory. In addition, Menarini is expected to purchase the Licensed Products from the Company in accordance with a supply agreement that is to be executed following the execution of the Menarini License and prior to commercialization. As such, the Company determined that the agreements should not be combined as a single contract pursuant to the guidance prescribed in ASC 606.
The Menarini License includes a non-refundable upfront payment, fixed reimbursements for the Company’s continued development costs, payments based upon the achievement of defined development, regulatory and
F- 16
commercial milestones, sales-based royalties, and certain cost sharing payments made by Menarini to the Company and by the Company to Menarini.
The Company has evaluated the Menarini License based on the requirements of ASC 606 and has concluded the following:
Within the license performance obligation described below, there are various licenses granted under the Menarini License which do not currently represent distinct performance obligations in themselves, as the licenses are highly interrelated and Menarini would likely be unable to derive significant benefits from their access to these licenses on an individual basis.
• The Company, considering that (i) there are no material restrictions included in the contract which would prevent Menarini to direct the use of, and obtain substantially all of the remaining benefits and (ii) the majority of the Company’s remaining development activities are in late-stage development and are not expected to significantly affect the functionality of the underlying intellectual property, concludes that the license as of the effective date of the contract has standalone value. As such, the Company concluded that the promise in granting the licenses to Menarini is to provide a right to use the Company’s intellectual property as it exists at the point in time at which the license is granted and therefore, revenue accrued and allocated to this performance obligation has been recognized at a point in time.
• The Company has also identified an additional performance obligation that consists of the research and development activities related to the general development and commercialization costs related to Licensed Products. The Company determined that this performance obligation is satisfied over time as Menarini simultaneously receives and consumes the benefits of the services provided as they are performed. This is based on the fact that Menarini is receiving status of the research periodically which allows it to make informed decisions in its local development activities. The Company further considered that the licenses and the research and development services are not highly interdependent or highly interrelated because the Company is able to fulfill its promise to transfer the licenses regardless of fulfilling its promise to perform the remaining research and development services. The Company also concluded that the licenses are considered distinct as Menarini could benefit from the licenses together with readily available resources other than the Company’s research and development services. The Company utilizes a cost-based input method to measure its progress toward completion of its performance obligation and to calculate the corresponding amount of revenue to recognize each period. The Company believes this is the best measure of progress because other measures do not reflect how the Company transfers its performance obligation to Menarini. In applying the cost-based input method of revenue recognition, the Company uses actual clinical study enrollment figures as well as actual costs incurred relative to budgeted costs expected to be incurred attributable to the Menarini Territory for the performance obligation. These costs consist primarily of third-party contract costs relative to the level of patient enrollment in the studies. Revenue will be recognized based on the level of costs incurred relative to the total budgeted costs for the performance obligation.
As such, two performance obligations for the Menarini License were identified at contract inception, comprising a license to use the Company’s intellectual property (the “license performance obligation”) and a promise to continue the development activities for the licensed compound (the “R&D performance obligation”).
The Company’s assessment of the transaction price included an analysis of amounts it expected to receive, which at contract inception consisted of the non-refundable, upfront payment of $ 120.9 million that was received by the Company in July 2022. The Company considers this non-refundable fee to be the initial transaction price.
The Company has allocated the transaction price to each performance obligation identified on a relative stand-alone selling price basis. The Company has used a combination of methods to calculate the stand-alone selling prices, using the expected cost plus a margin approach to calculate the standalone selling price of the research and development services required in the Menarini License and needed to commercialize obicetrapib in the Menarini Territory and the residual approach to calculate the stand-alone selling price for the license based on the fair value of the total promised goods and services in the Menarini License considering that the Company has not yet established a price for licenses, has not historically sold licenses on a stand-alone basis (i.e., the selling price is uncertain), and
F- 17
the amount allocated is consistent with the allocation objective as the Company believes the stated upfront amount is consistent with a risk-adjusted price that a market participant would be willing to pay for the licenses.
In 2022, at contract inception, the Company allocated $ 98.6 million to the license performance obligation which was immediately recognized as revenue in its consolidated statement of operations and comprehensive loss and $ 22.3 million to the R&D performance obligation, which is initially recognized as deferred revenue in the consolidated balance sheet. The revenue related to the R&D performance obligation is recognized over time as costs are incurred in connection with fulfilling the obligation. At each reporting date the Company reviews the total costs incurred to date and the total expected costs necessary to fulfill the R&D performance obligation. Revenue related to the R&D performance obligation is recognized based upon the percentage of total costs expected costs incurred to date based upon the latest information available to management.
The Menarini License also provides for certain milestone payments from Menarini to the Company upon the achievement of specified development, regulatory and commercial milestones linked to the enhanced value of the license performance obligation. More specifically, the Company is eligible to receive up to an additional € 863 million upon the achievement of various clinical, regulatory and commercial milestones. These milestones are contingent payments. These milestone payments represent variable consideration that are not initially recognized within the transaction price, due to the scientific uncertainties around the commercialization of the Licensed Products based on the success of clinical trials. At the end of each reporting period, the Company assessed the probability of significant reversals for any amounts that became likely to be realized prior to recognizing the variable consideration associated with these payments within the transaction price.
In January 2023, the Company achieved a clinical milestone related to our Phase 2 ROSE2 clinical trial which resulted in the recognition of $ 5.4 million of revenue. The associated milestone payment from Menarini was received in April 2023. Revenues related to the achievement of milestones under the Menarini License are attributed to the license performance obligation and are recorded when earned.
The deferred revenue is recognized within current and non-current liabilities based on the expected timing of the associated research and development services. In connection with the Menarini License, the company recognizes as current liabilities the amount for which it expects to perform the associated services within twelve months after the reporting period and the remaining amounts are recognized as non-current liabilities.
Lastly, the Company is entitled to receive tiered royalty payments based on annual aggregate net sales of all Licensed Products in the Menarini Territory, subject to specified reductions upon commercialization. The royalty term begins for each Licensed Product on a country-by-country basis upon the first commercial sale of such product in such country and ends on the later of (i) the expiration of the last-to-expire patent that includes a valid claim, (ii) the expiration of regulatory exclusivity in such country for such Licensed Product and (iii) a specified number of years after the first commercial sale of such Licensed Product in such country (the term of the agreement). In accordance with ASC 606, the Company recognizes revenue from royalty payments at the later of (i) the occurrence of the subsequent sale; or (ii) the performance obligation to which some or all of the sales-based milestone or royalty payments has been allocated has been satisfied. The Company anticipates recognizing these royalty payments if and when subsequent sales are generated from the Licensed Products.
To date the Menarini License has been the only source of revenue to the Company and all such revenues derive from Italy.
Revenue consisted of the following:
Year ended December 31,
(In thousands of USD)
2023
2022
2021
License revenue attributed from license performance obligation
5,385
98,613
—
License revenue attributed from R&D performance obligation
8,705
4,081
—
Total revenue
14,090
102,694
—
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The following table presents changes in the balance of the Company’s deferred revenue:
(In thousands of USD)
2023
2022
Beginning balance on January 1
18,666
—
Addition of deferred revenue under the Menarini License
—
22,332
Revenue recognized under the Menarini License during the period
( 8,705
)
( 4,081
)
Effect of currency translation
—
415
Ending balance on December 31
9,961
18,666
Note 5. Fair Value Measurements
As of December 31, 2023 and 2022, the Company’s financial liabilities recognized at fair value on a recurring basis consisted of the following:
As of December 31, 2023
(In thousands of USD)
Level 1
Level 2
Level 3
Total
Derivative warrant liability (Public Warrants)
12,051
—
—
12,051
Derivative warrant liability (Private Placement Warrants)
—
523
—
523
Derivative earnout liability
—
—
7,788
7,788
Total financial liabilities
12,051
523
7,788
20,362
As of December 31, 2022
(In thousands of USD)
Level 1
Level 2
Level 3
Total
Derivative warrant liability (Public Warrants)
4,002
—
—
4,002
Derivative warrant liability (Private Placement Warrants)
—
145
—
145
Derivative earnout liability
—
—
7,522
7,522
Total financial liabilities
4,002
145
7,522
11,669
The estimated fair value of the Earnout Shares to Participating Shareholders was determined using Level 3 inputs, other than the Company's share price as a Level 1 input, as no observable market inputs were available. The Earnout Shares allocated to Participating Shareholders have been measured at fair value using a Black-Scholes pricing model. Given the assumed zero dividend rate and the fact that no strike price exists that would have led to any volatility measure relative to the Company's share price, the fair value of the Earnout Shares allocated to Participating Shareholders resulting from the Black-Scholes pricing model is entirely driven by the Company’s closing share price as a Level 1 input and the probability of milestone completion as a Level 3 input. As such, the relevant inputs to the fair value of the derivative earnout liability are as follows:
December 31, 2023
December 31, 2022
Share value (USD)
11.17
10.90
Probability of milestone completion
40
%
40
%
Dividend yield
0
%
0
%
Strike price (USD)
0.00
0.00
As management's judgment of the probability of milestone completion remained constant during the period, the change in fair value resulted from the Company’s price per share between the valuations performed at the Closing Date and at December 31, 2022.
The following table presents a reconciliation of the earnout liability measured on a recurring basis using Level 3 inputs as of December 31, 2023 and 2022:
Opening balance as of November 22, 2022 (inception)
6,815
Change in fair value recognized through earnings
707
Balance on December 31, 2022
7,522
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Balance on December 31, 2022
7,522
Change in fair value recognized through earnings
266
Balance on December 31, 2023
7,788
All changes in fair value recognized in the statement of operations are unrealized. There were no sales, purchases, settlements or transfers into or out of Level 3 of the fair value hierarchy related to the earnout liability during the years ended December 31, 2023 and 2022.
Note 6. Prepayments and Other Receivables
Prepayments and other receivables consisted of the following:
As at December 31,
(In thousands of USD)
2023
2022
Prepaid research and development costs
2,337
5,771
Other prepaid expenses
2,123
2,410
Value added tax receivable
1,006
2,070
Other receivables
875
-
Total prepayments and other receivables
6,341
10,251
Note 7. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following:
As at December 31,
(in thousands of USD)
2023
2022
Accrued research and development materials and services
5,945
1,137
Accrued compensation and benefits
3,384
1,998
Accrued professional fees and other
2,069
2,982
Total accrued expenses and other current liabilities
11,398
6,117
Note 8. Shareholders’ Equity
The Company has an authorized share capital of 400,000,000 Ordinary Shares each with a nominal value of € 0.12 . The following summarizes the main rights of holders of Ordinary Shares:
• each holder of Ordinary Shares is entitled to one vote per share on all matters to be voted on by shareholders generally, including the appointment of our directors;
• there are no cumulative voting rights;
• the holders of Ordinary Shares are entitled to dividends and other distributions as may be declared from time to time by us out of funds legally available for that purpose, if any;
• upon our liquidation and dissolution, the holders of Ordinary Shares will be entitled to share ratably in the distribution of all of our assets remaining available for distribution after satisfaction of all our liabilities; and
• the holders of Ordinary Shares have pre-emption rights in case of share issuances or the grant of rights to subscribe for shares, except if such rights are limited or excluded by the corporate body authorized to do so and except in such cases as provided by Dutch law and the Articles of Association
FLAC Merger
On November 21, 2022 in connection with the Exchange, as described in Note 3, all the outstanding share capital of NewAmsterdam Pharma Holding B.V., consisting of 11,731,158 Series A Preferred Shares and 5,285,714 ordinary shares, was exchanged for Ordinary Shares of the Company at a ratio of approximately 2.13 per share. The Series A Preferred Shares were classified in accordance with ASC 480, Distinguishing Liabilities from Equity which required
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that the shares be classified outside of permanent shareholders’ equity. Accordingly, the Series A Preferred Shares were classified as Mezzanine Equity in the applicable periods.
At-the-Market Offering
On December 7, 2023, we entered into a sales agreement (the “Sales Agreement”) with Cowen and Company, LLC (“TD Cowen”), pursuant to which we may issue and sell from time to time up to $ 150 million of our Ordinary Shares through or to TD Cowen as our sales agent or acting as principal in any method deemed to be an “at the market offering.” TD Cowen will receive a commission of up to 3.0 % of the gross proceeds of any Ordinary Shares sold pursuant to the Sales Agreement. During the year ended December 31, 2023, we did not sell any Ordinary Shares pursuant to the Sales Agreement.
As of December 31, 2023 and 2022 only Ordinary Shares were outstanding or authorized. Historically, NewAmsterdam Pharma Holding B.V. also had preferred shares, classified as Mezzanine Equity, which all converted into Ordinary Shares as described in Note 3. The preferred shares had liquidation preference and the shareholders thereof were in the position to trigger the occurrence of a liquidation event or deemed liquidation event.
Note 9. Share-Based Compensation
The Company has three Share-based payment plans and one restricted share award in place as at December 31, 2023:
• The Company’s Long-Term Incentive Plan (the “Plan”);
• The Company’s Supplementary Long-Term Incentive Plan (the “Supplementary Plan”);
• The Company’s Rollover Option Plan (the “Rollover Plan,” together with the Plan and the Supplementary Plan, the “Plans”); and
• Chief Executive Officer Restricted Share Award.
Long Term Incentive Plans
The Plans are equity-settled, and the Company may grant various forms of equity awards, including the granting of options to purchase Ordinary Shares (“Company Options”) and restricted stock units (“RSUs”), pursuant to the Plans. In total, as of December 31, 2023 a maximum of 16,425,868 Ordinary Shares may be reserved for issuance pursuant to the Plans. The number of Ordinary Shares reserved for grant under the Plan will increase annually on January 1 of each calendar year by 5 % of the then issued and outstanding Ordinary Shares or such lower number as may be determined by the Board of Directors.
The contractual term is 10 years from grant date for options granted under the Plans In general, each Company Option granted in 2023 has a four-year vesting period with 25 % vesting after one year and the remaining 75 % vesting in equal monthly installments over the next following three years .
Modification of Options During the Year
In 2023, the vesting period was shortened for 490,067 Company Options granted to an employee in relation with the signing of an employment separation agreement. At the modification date, 255,243 Company Options were expected to vest both under the original and the modified vesting conditions. For these Company Options, the modification did not result in any incremental compensation cost. For the 234,824 Company Options that were not probable to vest as of the modification date based on the original terms, the incremental fair value granted is equal to the fair value of the modified award of $ 12.19 (i.e., the value of the modified award, as determined on the modification date, compared to its prior zero value). In 2023, the total incremental fair value of $ 2.9 million has been fully recognized over the remaining modified requisite service period.
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The changes for the year ended December 31, 2023 in the number of Company Options outstanding related to Ordinary Shares and their related weighted average exercise prices are as follows:
Number of options
Weighted average exercise price
Weighted average remaining contractual term
(in years)
Aggregate intrinsic value
(in thousands of USD)
Outstanding as at December 31, 2022
11,146,861
$
6.71
Granted
6,829,024
$
10.63
Exercised
( 160,247
)
$
1.81
Forfeited
( 2,032,129
)
$
10.51
Outstanding as at December 31, 2023
15,783,509
$
7.98
8.7
50,796
Options exercisable as of December 31, 2023
5,230,531
$
4.08
8.0
37,101
The weighted average grant date fair value of options, estimated as of the grant date using the Black-Scholes option pricing model, was $ 4.70 , $ 4.32 and $ 1.11 per option for options granted during the years ended December 31, 2023, 2022 and 2021, respectively. The total intrinsic value (the amount by which the fair market value exceeded the exercise price) of stock options exercised during the years ended December 31, 2023 was $ 1.7 million. No stock options were exercised in 2022 or 2021. Weighted average assumptions used to apply this pricing model were as follows:
Year ended December 31,
2023
2022
2021
Expected life (years)
6.1
6.0
5.6
Risk-free rate
4.1
%
3.9
%
- 0.6
%
Volatility
38.1
%
38.8
%
42.9
%
Dividend yield
0.0
%
0.0
%
0.0
%
Expected Term
The Company’s expected term represents the period that the Company’s stock-based awards are expected to be outstanding and is determined using the simplified method (based on the mid-point between the vesting date and the end of the contractual term). The Company utilizes this method due to lack of historical exercise data and the plain-vanilla nature of the Company’s stock-based awards.
Expected Volatility
Since the Company was privately held through November 2022, it alone does not have the relevant company-specific historical data to support its expected volatility. As such, the Company has used an average of expected volatilities based on the volatilities of a representative group of publicly traded biopharmaceutical companies over a period equal to the expected term of the stock option grants. For purposes of identifying comparable companies, the Company selected companies with comparable characteristics to it, including enterprise value, risk profiles, position within the industry, and with historical share price information sufficient to meet the expected life of the stock-based awards. The historical volatility data was computed using the daily closing prices for the selected companies’ shares during the equivalent period of the calculated expected term of the stock-based awards. The Company intends to consistently apply this process using the same or similar comparable entities until sufficient historical information regarding the volatility of the Company’s own share price becomes available.
Risk-Free Interest Rate
The risk-free interest rate is based upon the U.S. Treasury yield curve in effect at the time of grant, with a term that approximates the expected life of the option.
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Expected Dividend
The expected dividend rate is zero as the Company currently has no history or expectation of declaring dividends on its ordinary shares.
Share-based compensation is classified in the consolidated statement of operations and comprehensive loss as follows:
Year ended December 31,
(in thousands of USD)
2023
2022
2021
Research and development expenses
14,521
2,408
877
Selling, general and administrative expenses
10,051
1,770
335
Total
24,572
4,178
1,212
As of December 31, 2023, there was $ 25.2 million of unrecognized compensation cost related to Company Options that have not yet vested. These costs are expected to be recognized over a weighted average remaining vesting period of 1.4 years.
Restricted Stock Units (“RSUs”)
As at December 31, 2023 and 2022 the Company had allocated 143,002 and 160,778 Earnout Shares, respectively, to be granted to Participating Optionholders if and when a certain clinical development milestone is achieved during the earnout period. These Earnout Shares will be delivered in the form of awards of RSUs granted pursuant to the Plan to such Participating Optionholders who are at the time of achievement of such milestone still providing services to the Company.
The development milestone consists of the achievement and public announcement of Positive Phase 3 Data for each of the Company’s BROADWAY clinical trial and BROOKLYN clinical trial at any time during the period beginning on November 22, 2022 and ending on the date that is five years after such date.
There is no impact on these financial statements with respect to these RSUs due to the uncertainty of achieving the clinical development milestone.
Chief Executive Officer Restricted Share Award
In July 2021, our chief executive officer, Michael Davidson, M.D., paid the fair market value of the underlying ordinary shares (in aggregate $ 838,806 ) when he made an investment in restricted shares issued through Depositary Receipts. The total fair value of these equity-settled share-based payment awards amounts to nil and there will be no expenses recognized in the income statement. This award had a four year vesting period with 25 % vesting on August 1, 2021 and the remaining 75 % vesting in equal monthly installments over the following three years .
In connection with the award arrangement, if Dr. Davidson leaves the Company, all unvested Ordinary Shares will be cancelled against payment by the Company to him of the lower of the (i) the purchase price paid and (ii) the fair market value of such Ordinary Shares at the time of forfeiture. In order to reflect the consideration paid and the possibility that the Ordinary Shares would be repurchased if Dr. Davidson becomes a "Good Leaver" (as such term is defined in the award agreement) during the vesting period, the Company has recognized the consideration as a financial liability until the award has fully vested, at which time it will be reclassified to equity provided that Dr. Davidson remains with the Company. This liability is measured at the lower of (i) the purchase price paid and (ii) the fair market value of the Ordinary Shares at the end of the reporting period. The liability for unvested Ordinary Shares as at December 31, 2023 and 2022 amounted to $ 0.1 million and $ 0.3 million, respectively.
F- 23
For the year ended December 31, 2023, the movements in the number of Ordinary Shares outstanding are as follows:
Outstanding as at December 31, 2022
608,779
Granted/purchased during the year
—
Outstanding as at December 31, 2023
608,779
As of December 31, 2023 and 2022, a total of 519,999 and 367,804 Ordinary Shares had vested, respectively.
Note 10. Income Taxes
The Company’s breakdown of its income before provision for income taxes for the years ended December 31, 2023, 2022 and 2021 is as follows:
Year ended December 31,
(In thousands of USD)
2023
2022
2021
U.S.
( 107,555
)
( 604
)
( 13,542
)
Netherlands
( 69,355
)
( 22,030
)
( 28,243
)
Total
( 176,910
)
( 22,634
)
( 41,785
)
The components of our provision for income taxes for the years ended December 31, 2023, and 2022, are as follows:
Year ended December 31,
(In thousands of USD)
2023
2022
2021
Current:
State
—
—
—
Federal
27
—
—
Total current
27
—
—
Deferred:
State
—
—
—
Federal
—
—
—
Total deferred
—
—
—
Provision for income taxes
27
—
—
A reconciliation of the statutory federal income tax rate to our effective tax rate is as follows:
Year ended December 31,
2023
2022
2021
Income tax at the federal statutory rate
25.80
%
25.80
%
25.80
%
Foreign rate differential
( 2.94
%)
( 0.13
%)
( 1.56
%)
State taxes, net of federal benefit
0.71
%
( 0.03
%)
—
FDII deduction
—
0.24
%
—
Warrants
( 1.50
%)
( 1.19
%)
—
Tax credits
5.31
%
0.73
%
—
Transaction costs
—
24.59
%
—
Share listing expense
—
6.96
%
7.63
%
Change in valuation allowance
( 27.40
%)
( 57.30
%)
( 31.86
%)
Other
—
0.33
%
( 0.01
%)
Effective tax rate
- 0.02
%
0.00
%
0.00
%
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Deferred income taxes reflect the tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of our deferred tax assets are as follows as of December 31, 2023 and 2022:
Year ended December 31,
(In thousands of USD)
2023
2022
Deferred tax assets:
Amortization and depreciation
21,176
371
Accruals
509
167
Net operating loss carryforwards
75,686
57,766
Lease liability
13
29
IPR&D
22,884
22,884
Tax credit, federal
6,904
167
Tax credit, Massachusetts
2,685
23
Gross deferred tax assets
129,857
81,407
Valuation allowance
( 129,845
)
( 81,380
)
Deferred tax assets net of valuation allowance
12
27
Deferred tax liabilities:
Right-of-use-asset
( 12
)
( 27
)
Net deferred tax assets
—
—
Realization of deferred tax assets is dependent on future taxable income, if any, the timing and the amount of which are uncertain. We assess the available positive and negative evidence to estimate whether sufficient future taxable income will be generated to permit use of the existing deferred tax assets. A significant component of objective negative evidence evaluated was our cumulative loss incurred over the three-year period ended December 31, 2023. Such objective evidence limits the ability to consider other subjective evidence, such as our projections for future growth. On the basis of this evaluation, as at December 31, 2023, December 31, 2022 and December 31, 2021, a full valuation allowance has been recorded against our net deferred tax asset. As of December 30, 2023, and December 31, 2022, the Company had a valuation allowance of $ 129.8 million and $ 81.4 million, respectively, recorded on the balance sheet. A valuation allowance is a non-cash charge, and does not limit the Company’s ability to utilize its deferred tax assets, including its ability to utilize tax loss and credit carryforward amounts, against future taxable income. The amount of the deferred tax asset considered realizable, however, could be adjusted if estimates of future taxable income during the carryforward period are reduced or increased or if objective negative evidence in the form of cumulative losses is no longer present and additional weight is given to subjective evidence such as our projections for growth.
As of December 31, 2023, we had net operating loss carryforwards for Netherlands fiscal unity, US, and state income tax purposes of $ 274.6 million, $ 22.2 million, and $ 4.3 million, respectively. We also have federal research and development tax credit carryforwards of approximately $ 6.9 million that expire beginning in 2042 and state research and development tax credit carryforwards of approximately $ 2.7 million which can be carried forward indefinitely.
The future utilization of net operating loss and tax credit carryforwards and credits may be subject to an annual limitation, due to Dutch and US tax law and as a result of ownership changes that may have occurred previously or that could occur in the future. Due to the existence of the valuation allowance, limitations will not impact our effective tax rate.
We recognize a tax benefit from an uncertain tax position when it is more likely than not that the position will be sustained upon examination, including resolutions of any related appeals or litigation processes, based on the technical merits. Income tax positions must meet a more likely than not recognition at the effective date to be recognized. As of December 31, 2023 we have no t identified any unrecognized tax benefits that should be recorded.
We have elected to include interest and penalties as a component of tax expense. During the years ended December 31, 2023, 2022 and 2021, we did no t recognize accrued interest and penalties related to unrecognized tax benefits.
F- 25
Although the timing and outcome of an income tax audit is highly uncertain, we do not anticipate that the amount of existing unrecognized tax benefits will significantly change during the next 12 months.
With an effective date of November 21, 2022, NewAmsterdam Pharma Company N.V. formed a fiscal unity with NewAmsterdam Pharma Holding B.V. and NewAmsterdam Pharma B.V. for corporate income tax purposes. A company and its subsidiaries that are part of the fiscal unity are jointly and severally liable for the tax payable by the fiscal unity.
We are subject to taxation in the United States, the Netherlands and various state jurisdictions. As of December 31, 2023, the tax years for 2020, 2021, and 2022 are subject to examination by the tax authorities in the United States and the tax year for 2022 are subject to examination by the tax authorities in the Netherlands. Due to our net operating loss and tax credit carryforwards, the income tax returns remain open to U.S. federal and state tax examinations. The Company is not currently under examination in any tax jurisdiction.
Note 11. Net Loss per Ordinary Share
As discussed in Note 3, in connection with the Business Combination the Participating Shareholders exchanged their interest in the outstanding shares of NewAmsterdam Pharma Holding B.V. for shares in the Company at a ratio of approximately 2.13 . In order to present net loss per ordinary share on a comparable basis across all periods, the number of ordinary shares outstanding prior to the Business Combination have been adjusted for the exchange ratio of approximately 2.13 for the purposes of calculating the number of weighted average shares outstanding.
Basic and diluted net loss per ordinary share was calculated as follows:
Year ended December 31,
(In thousands of USD, except share and per share amounts)
2023
2022
2021
Net loss
( 176,937
)
( 22,634
)
( 41,785
)
Weighted average ordinary shares outstanding, basic and diluted
82,161,956
18,966,235
10,978,874
Net loss per ordinary share, basic and diluted
( 2.15
)
( 1.19
)
( 3.81
)
The following potentially dilutive securities have been excluded from the computation of diluted weighted-average ordinary shares outstanding as they would be anti-dilutive:
Year ended December 31,
2023
2022
2021
Stock options
15,783,509
11,146,861
4,185,360
Outstanding warrants
4,017,221
4,767,000
-
Total
19,800,730
15,913,861
4,185,360
Note 12. Benefit Plan
The Company sponsors a 401(k) retirement plan for its U.S. employees. The plan allows eligible employees to voluntarily defer a portion of their annual compensation on a pre-tax basis, subject to the maximum annual amounts as set periodically by the IRS. The Company makes matching contributions of 100 % of the first 3 % of employee contributions and 50 % of the next 2 % of employee contributions. The Company made matching contributions of $ 120 thousand, $ 70 thousand and $ 40 thousand for the years ended December 31, 2023, 2022 and 2021, respectively. Company contributions vest immediately for each participant.
Note 13. Commitments and Contingencies
Commitments
The Company has entered into a variety of agreements financial commitments in the normal course of business with contract research organizations, contract manufacturing organizations, and other third parties for preclinical and clinical development and manufacturing services. The terms generally provide us with the option to cancel, reschedule and adjust our requirements based on our business needs, prior to the delivery of goods or performance
F- 26
of services. Payments due upon cancellation generally consist only of payments for services provided or expenses incurred, including non-cancellable obligations of our service providers, up to the date of cancellation. However, some of our service providers also charge cancellation fees upon cancellation. The amount and timing of such payments are not known, but at December 31, 2023 they are estimated to be a maximum of $ 15.7 million.
According to the terms of the Menarini License the Company will be responsible for development and commercialization costs related to Licensed Products other than those in the Menarini Territory. In addition, under specified conditions of the agreement, we agreed to bear 50 % of certain development costs incurred by the other party in the development of the Licensed Products in the Menarini Territory.
Note 14. Related Parties
In the ordinary course of business, the Company may enter into transactions with entities that are associated with a party that meets the criteria of a related party of the Company. These transactions are reviewed quarterly and to date have not been material to the Company’s consolidated financial statements.
Note 15. Subsequent Events
On January 1, 2024, the Company granted options to purchase an aggregate of 3,362,748 Ordinary Shares to certain employees and directors. Such options each have an expiration date of ten years from the date of grant and an exercise price of $ 11.17 .
On February 16, 2024, we completed an underwritten public offering (the “Offering”) of 5,871,909 Ordinary Shares at a public offering price of $ 19.00 per Ordinary Share and, in lieu of Ordinary Shares to certain investors, pre-funded warrants (“Pre-Funded Warrants”) to purchase 4,736,841 Ordinary Shares at a public offering price of $ 18.9999 per Pre-Funded Warrant, which represents the per share public offering price for the Ordinary Shares less the $ 0.0001 per share exercise price for each such Pre-Funded Warrant. Of the 5,871,909 Ordinary Shares issued and sold in the Offering, 1,383,750 Ordinary Shares were issued and sold pursuant to the exercise of the underwriters’ option to purchase additional Ordinary Shares at the public offering price per share. The Ordinary Shares and Pre-Funded Warrants were issued and sold pursuant to an underwriting agreement among the Company and Jefferies LLC, Leerink Partners LLC, Piper Sandler & Co. and RBC Capital Markets, LLC, as representatives of the several underwriters listed on Schedule A thereto. The net proceeds to the Company from the Offering were $ 189.8 million after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company.
F- 27