ニューアムステルダムファーマの四半期報告

Balance on December 31, 2024

Change in fair value recognized through profit and loss

Settlement of derivative earnout liability upon achievement of milestone

Balance on September 30, 2025

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-Q

(Mark One)


☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2025


☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number: 001-41562

NewAmsterdam Pharma Company N.V.

(Exact Name of Registrant as Specified in its Charter)


The Netherlands	N/A
( State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)
Gooimeer 2-35 Naarden The Netherlands	1411 DC
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: +31 (0) 35 206 2971

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Ordinary Shares, nominal value €0.12 per share	NAMS	The Nasdaq Stock Market LLC
Warrants to purchase Ordinary Shares	NAMSW	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer	☒	Accelerated filer	☐
Non-accelerated filer	☐	Smaller reporting company	☐
Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of October 31, 2025, the registrant had 113,390,804 ordinary shares, nominal value €0.12 per share, outstanding.

TABLE OF CONTENTS


		Page

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS		2

PART I.	FINANCIAL INFORMATION	4

Item 1.	Financial Statements (Unaudited)	4
	Condensed Consolidated Balance Sheets	4
	Condensed Consolidated Statements of Operations and Comprehensive Loss	5
	Condensed Consolidated Statements of Shareholders' Equity	6
	Condensed Consolidated Statements of Cash Flows	7
	Notes to Unaudited Condensed Consolidated Financial Statements	8
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	16
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	27
Item 4.	Controls and Procedures	28

PART II.	OTHER INFORMATION	29

Item 1.	Legal Proceedings	29
Item 1A.	Risk Factors	29
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	31
Item 3.	Defaults Upon Senior Securities	32
Item 4.	Mine Safety Disclosures	32
Item 5.	Other Information	32
Item 6.	Exhibits	33
SIGNATURES		34

_________________________

Unless otherwise stated or the context otherwise indicates, references to “we,” “our,” “us” or the “Company” refer to NewAmsterdam Pharma Company N.V., together with its subsidiaries.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q (“Quarterly Report”) contains forward-looking statements. Forward-looking statements provide the Company’s current expectations or forecasts of future events. Forward-looking statements include statements about the Company’s expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Words or phrases such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will” and “would,” or similar words or phrases, or the negatives of those words or phrases, may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. Examples of forward-looking statements in this Quarterly Report include, but are not limited to, statements regarding the Company’s future operations, cash flows, financial position, dividend policy, prospects, strategies, objectives and other future events.

Forward-looking statements in this Quarterly Report and in any document incorporated by reference in this Quarterly Report may include, for example, statements about:

•

the potential liquidity and trading of the Company’s public securities;

•

the Company’s ability to raise additional capital in sufficient amounts or on terms acceptable to it;

•

the efficacy and safety of the Company’s product candidates, obicetrapib as a monotherapy and as a fixed-dose combination therapy with ezetimibe, as well as potential reimbursement and anticipated market size and market opportunity;

•

the Company’s dependence on the success of obicetrapib as a monotherapy and as a fixed-dose combination therapy with ezetimibe, including the obtaining of regulatory approval of such product candidates;

•

the timing, progress and results of clinical trials for the Company's product candidates, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work and the period during which results of trials will become available and marketing submissions made;

•

the Company’s ability to attract and retain senior management and key scientific personnel;

•

the Company’s limited experience in marketing or distributing products;

•

managing the risks related to the Company’s international operations;

•

the Company’s ability to achieve the broad degree of physician adoption and use and market acceptance necessary for commercial success;

•

the Company’s estimates regarding expenses, future revenue, capital requirements and needs for additional financing;

•

developments regarding the Company’s competitors and the Company’s industry;

•

the impact of government laws and regulations;

•

the Company’s reliance on third parties for all aspects of the manufacturing of the Company's product candidates for clinical trials; and

•

the Company’s efforts to obtain, protect or enforce its patents and other intellectual property rights related to the Company’s product candidates.

Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. Actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors described in the section titled “Risk Factors” in this Quarterly Report and in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission ("SEC"). Accordingly, you should not place undue reliance on these forward-looking statements, which speak only as of the date of this Quarterly Report. The Company undertakes no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this Quarterly Report or to reflect the occurrence of unanticipated events, except as specifically required by law. You should, however, review the factors and risks that the Company describes in the reports it files from time to time with the SEC.

In addition, statements that “we believe” and similar statements reflect the Company’s beliefs and opinions on the relevant subject. These statements are based on information available to the Company as of the date of this Quarterly Report. And while the Company believes that information provides a reasonable basis for these statements, that information may be limited or incomplete. The Company’s statements should not be read to indicate that it has conducted an exhaustive inquiry into, or review of, all relevant information. These statements are inherently uncertain, and you are cautioned not to unduly rely on these statements.

Although the Company believes the expectations reflected in the forward-looking statements were reasonable at the time made, it cannot guarantee future results, level of activity, performance, achievements or events.

You should carefully consider the cautionary statements contained or referred to in this section in connection with the forward-looking statements contained in this Quarterly Report and any subsequent written or oral forward-looking statements that may be issued by the Company or persons acting on its behalf.

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

NewAmsterdam Pharma Company N.V.

Condensed Consolidated Balance Sheets

(Unaudited)


	September 30, 2025			December 31, 2024
(In thousands of USD)
Assets
Current assets:
Cash and cash equivalents		538,407			771,743
Prepayments and other receivables		28,074			24,272
Employee receivables		—			4,951
Marketable securities, current		164,539			62,447
Restricted cash		1,308			—
Total current assets		732,328			863,413
Marketable securities, net of current portion		53,091			—
Property, plant and equipment, net		323			242
Operating right of use asset		246			431
Intangible assets		439			534
Total assets		786,427			864,620
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable		3,632			4,744
Accrued expenses and other current liabilities		10,098			13,608
Deferred revenue, current		—			6,008
Lease liability, current		181			246
Derivative earnout liability, current		—			44,798
Derivative warrant liabilities		44,361			37,514
Total current liabilities		58,272			106,918
Lease liability, net of current portion		85			202
Total liabilities		58,357			107,120
Commitments and contingencies (Note 12)
Shareholders' Equity (deficit):
Ordinary shares, €0.12 par value; 400,000,000 shares authorized; 113,172,684 and 108,064,340 shares issued and outstanding as at September 30, 2025 and December 31, 2024, respectively		14,107			13,444
Additional paid-in capital		1,396,790			1,298,160
Accumulated loss		(687,467	)		(558,571	)
Accumulated other comprehensive income		4,640			4,467
Total shareholders' equity		728,070			757,500
Total liabilities and shareholders' equity		786,427			864,620

See notes to consolidated financial statements.

NewAmsterdam Pharma Company N.V.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)


	For the three months ended September 30,						For the nine months ended September 30,
	2025			2024			2025			2024
(In thousands of USD, except per share amounts)
Revenue		348			29,111			22,471			32,791
Operating expenses:
Research and development expenses		30,971			35,702			103,238			116,511
Selling, general and administrative expenses		24,520			18,412			78,936			49,340
Total operating expenses		55,491			54,114			182,174			165,851
Operating loss		(55,143	)		(25,003	)		(159,703	)		(133,060	)
Other income (expense):
Interest income		6,713			4,443			21,119			12,396
Fair value change – earnout		—			(5,414	)		3,992			(11,020	)
Fair value change – warrants		(23,792	)		4,644			(7,440	)		(19,008	)
Loss on disposal of property, plant and equipment		(1	)		—			(1	)		—
Foreign exchange gains/(losses)		218			4,682			13,137			1,270
Loss before tax		(72,005	)		(16,648	)		(128,896	)		(149,422	)
Income tax expense (benefit)		—			(1	)		—			(1	)
Loss for the period		(72,005	)		(16,647	)		(128,896	)		(149,421	)
Other comprehensive income/(loss)
Unrealized gain/(loss) on available-for-sale securities, net of tax		313			—			173			—
Total comprehensive loss for the period, net of tax		(71,692	)		(16,647	)		(128,723	)		(149,421	)
Net loss per ordinary share
Basic and diluted	$	(0.61	)	$	(0.18	)	$	(1.09	)	$	(1.61	)

See notes to consolidated financial statements.

NewAmsterdam Pharma Company N.V.

Condensed Consolidated Statements of Shareholders' Equity

(Unaudited)


(In thousands of USD, except share amounts)	Shares		Amount		Additional Paid-In Capital			Accumulated Loss			Accumulated Other Comprehensive Income			Total Shareholders' Equity
Balance at December 31, 2023		82,469,768		10,173		590,771			(316,973	)		4,422			288,393
Issuance of Ordinary Shares and Pre-Funded Warrants, net of issuance costs		5,871,909		759		189,207			—			—			189,966
Exercise of warrants		926,698		121		19,674			—			—			19,795
Exercise of stock options		452,461		60		(609	)		—			—			(549	)
Share-based compensation		—		—		7,965			—			—			7,965
Total loss and comprehensive loss for the period		—		—		—			(93,767	)		—			(93,767	)
As at March 31, 2024		89,720,836		11,113		807,008			(410,740	)		4,422			411,803
Exercise of warrants		294,521		38		6,268			—			—			6,306
Share-based compensation		—		—		8,337			—			—			8,337
Total loss and comprehensive loss for the period		—		—		—			(39,007	)		—			(39,007	)
As at June 30, 2024		90,015,357		11,151		821,613			(449,747	)		4,422			387,439
Exercise of Pre-Funded Warrants		2,105,248		279		(279	)		—			—			—
Exercise of stock options		45,000		5		53			—			—			58
Share-based compensation		—		—		8,012			—			—			8,012
Total loss and comprehensive loss for the period		—		—		—			(16,647	)		—			(16,647	)
As at September 30, 2024		92,165,605		11,435		829,399			(466,394	)		4,422			378,862

Balance at December 31, 2024		108,064,340		13,444		1,298,160			(558,571	)		4,467			757,500
Issuance of Earnout Shares		1,743,136		226		40,581			—			—			40,807
Exercise of Pre-Funded Warrants		1,293,938		162		(162	)		—			—			—
Exercise of warrants		15,942		2		410			—			—			412
Exercise of stock options		909,140		116		2,875			—			—			2,991
Vesting of RSUs		142,795		18		(18	)		—			—			—
Share-based compensation		—		—		15,213			—			—			15,213
Total loss and comprehensive loss for the period		—		—		—			(39,527	)		(33	)		(39,560	)
As at March 31, 2025		112,169,291		13,968		1,357,059			(598,098	)		4,434			777,363
Exercise of warrants		100		—		2			—			—			2
Exercise of stock options		340,317		46		3,378			—			—			3,424
Vesting of RSUs		206		—		—			—			—			—
Share-based compensation		—		—		15,179			—			—			15,179
Total loss and comprehensive loss for the period		—		—		—			(17,364	)		(107	)		(17,471	)
As at June 30, 2025		112,509,914		14,014		1,375,618			(615,462	)		4,327			778,497
Exercise of warrants		23,826		4		633			—			—			637
Exercise of stock options		638,944		89		5,529			—			—			5,618
Share-based compensation		—		—		15,010			—			—			15,010
Total loss and comprehensive loss for the period		—		—		—			(72,005	)		313			(71,692	)
As at September 30, 2025		113,172,684		14,107		1,396,790			(687,467	)		4,640			728,070

See notes to consolidated financial statements.

NewAmsterdam Pharma Company N.V.

Condensed Consolidated Statements of Cash Flows

(Unaudited)


	For the nine months ended September 30,
	2025			2024
(In thousands of USD)
Operating activities:
Loss for the period		(128,896	)		(149,421	)
Non-cash adjustments to reconcile loss before tax to net cash flows:
Depreciation and amortization		161			62
Non-cash rent expense		3			8
Fair value change - derivative earnout and warrants		3,448			30,028
Loss on disposal of property, plant and equipment		1			—
Foreign exchange (gains)/losses		(13,137	)		(1,270	)
Amortization of premium/discount on available-for-sale debt securities		(1,381	)		—
Share-based compensation		45,402			24,204
Changes in working capital:
Changes in prepayments and other receivables		(3,216	)		(8,769	)
Changes in accounts payable		(409	)		(9,751	)
Changes in accrued expenses and other current liabilities		(2,876	)		(708	)
Changes in deferred revenue		(6,008	)		(5,466	)
Net cash used in operating activities		(106,908	)		(121,083	)
Investing activities:
Purchase of property, plant and equipment, including internal use software		(146	)		(669	)
Maturities of marketable securities		71,563			—
Purchases of marketable securities		(225,192	)		—
Net cash used in investing activities		(153,775	)		(669	)
Financing activities:
Proceeds from February 2024 offering of Ordinary Shares and Pre-Funded Warrants		—			190,481
Transaction costs on February 2024 issue of Ordinary Shares and Pre-Funded Warrants		—			(515	)
Transaction costs on December 2024 issue of Ordinary Shares and Pre-Funded Warrants		(1,586	)		—
Proceeds from exercise of warrants		458			13,421
Proceeds from exercise of options		16,964			498
Payment of withholding taxes related to net share settlement of exercised options		—			(989	)
Net cash provided by financing activities		15,836			202,896
Net change in cash, cash equivalents and restricted cash		(244,847	)		81,144
Foreign exchange differences		12,819			1,135
Cash, cash equivalents and restricted cash at the beginning of the period		771,743			340,450
Cash, cash equivalents and restricted cash at the end of the period		539,715			422,729
Noncash financing and investing activities
Right-of-use assets obtained in exchange for new operating lease liabilities		—			562
Issuance of earnout shares		40,807			—

Reconciliation of cash, cash equivalents and restricted cash to the Condensed Consolidated Balance Sheets
Cash and cash equivalents		538,407			422,729
Restricted cash		1,308			—
		539,715			422,729

See notes to consolidated financial statements

NewAmsterdam Pharma Company N.V.

Notes to Unaudited Condensed 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 ("Nasdaq") and trade under the symbol “NAMS.”

On September 24, 2025, NewAmsterdam Pharma Holding B.V., a non-operating, wholly-owned subsidiary of the Company, merged with and into NewAmsterdam Pharma Company N.V. On the same date, Frazier Life Sciences Acquisition Corporation, a non-operation, wholly-owned subsidiary of the Company, merged with and into NewAmsterdam Pharma Corporation, a wholly-owned subsidiary of the Company. The transactions represent combinations between entities under common control. NewAmsterdam Pharma Holding B.V. and Frazier Life Sciences Acquisition Corporation had no material operations and the mergers had no impact on the consolidated financial statements of the Company. As such, no separate pre-combination results are presented.

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.

Note 2. Summary of Significant Accounting Policies

Basis of Presentation

The unaudited condensed consolidated financial statements should be read together with our audited financial statements and accompanying notes for year ended December 31, 2024, included in our Annual Report on Form 10-K (the "Annual Report"), filed with the U.S. Securities and Exchange Commission (the “SEC”) on February 26, 2025. Any terms not defined herein take the meaning as defined in the Annual Report. The Company’s unaudited condensed 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 SEC regarding interim financial reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP have been condensed or omitted, and accordingly the balance sheet as of December 31, 2024 included herein has been derived from the audited financial statements at that date but does not include all of the information required by U.S. GAAP for complete financial statements. These unaudited interim condensed consolidated financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments which are necessary for a fair statement of the Company’s financial information. The interim results of operations for the three and nine months ended September 30, 2025 are not necessarily indicative of the results to be expected for the year ending December 31, 2025 or for any other interim period or for any other future year. The unaudited condensed consolidated financial statements comprise the financial statements of the Company and its subsidiaries. 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 unaudited condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, after elimination of intercompany accounts and transactions.

Except for the policy described below, the accounting policies of the Company are consistent with those described in Note 2 of the consolidated financial statements included within the Annual Report.

Restricted Cash

The Company maintains certain cash balances restricted to withdrawal or use. Restricted cash includes cash held as collateral for certain contractual agreements.

Note 3. Revenue

Menarini Supply Agreement

On August 12, 2025, NewAmsterdam Pharma B.V. entered into a supply agreement with A. Menarini International Licensing S.A. (“Menarini”) to provide commercial supply of Products (as defined below) for distribution in specified European territories (the “Menarini Supply Agreement”).

The Company recognizes revenue from the sale of obicetrapib tablets, as a monotherapy and as a fixed-dose combination therapy with ezetimibe, or from the sale of active pharmaceutical ingredients for the manufacture of such tablets (collectively, “Products”). The Company’s product supply revenue is recognized at a point in time when the performance obligation is satisfied by transferring control of the promised goods or services to the customer and it is probable that it will collect the consideration to which it is entitled. In accordance with the terms of the Menarini Supply Agreement, control of the product is transferred upon the conveyance of title, which occurs when the product is made available to the customer.

The transaction price is contractually fixed at a markup of the actual cost of goods sold. Due to the cost-based nature of the agreement, the pricing structure includes a variable component which is measured using the expected value method. At each reporting period end, the Company updates its estimate of the transaction price using actual cost data and forecasted expenses. The Company considers the variable consideration constraint under ASC 606 to ensure that it is probable that a significant reversal of cumulative revenue recognized will not occur. The Company will invoice the customer upon the acceptance of purchase orders and is not adjusted for a significant financing component as the period between the transfer of goods and payment is less than one year. The Company states revenues net of any taxes collected from customers that are required to be remitted to various government agencies. The amount of taxes collected from customers and payable to governmental entities is included on the balance sheet as part of accrued expenses and other current liabilities.

Revenue consisted of the following:


	Three months ended September 30,				Nine months ended September 30,
(In thousands of USD)	2025		2024		2025		2024
License revenue attributed from license performance obligation		—		27,325		—		27,325
License revenue attributed from R&D performance obligation		—		1,786		22,123		5,466
Supply revenue		348		—		348		—
Total revenue		348		29,111		22,471		32,791

During the nine months ended September 30, 2025 it was determined that the R&D performance obligation was satisfied in full and, as such, all of the deferred revenue on the consolidated balance sheet as of January 1, 2025 has been recognized as revenue during the period. In addition, during the nine months ended September 30, 2025, it was determined that the second of two development cost reimbursements was probable to be realized with no significant reversals. As such, the amount of the reimbursement was added to the transaction price resulting in the recognition of $16.1 million in revenue attributed to the R&D performance obligation.

Note 4. Cash, cash equivalents and marketable securities

A summary of cash, cash equivalents and marketable securities held by the Company as of September 30, 2025 and December 31, 2024 is as follows:


	As at September 30, 2025
(In thousands of USD)	Amortized cost		Unrealized gains		Unrealized losses			Fair value
Cash and cash equivalents:
Cash		500,953		—		—			500,953
Money market funds (Level 1)		37,454		—		—			37,454
Total cash and cash equivalents		538,407		—		—			538,407
Marketable securities
US government securities due within one year (Level 1)		149,451		105		—			149,556
US government agency securities due within one year (Level 2)		14,985		—		(2	)		14,983
US government securities due between one and two years (Level 1)		40,738		115		(2	)		40,851
US government agency securities due between one and two years (Level 2)		12,238		9		(7	)		12,240
Total marketable securities		217,412		229		(11	)		217,630


	As at December 31, 2024
(In thousands of USD)	Amortized cost		Unrealized gains		Unrealized losses		Fair value
Cash and cash equivalents:
Cash		733,826		—		—		733,826
Money market funds (Level 1)		25,444		—		—		25,444
US government agency securities (Level 2)		12,473		—		—		12,473
Total cash and cash equivalents		771,743		—		—		771,743
Marketable securities
US government securities due within one year (Level 1)		37,711		34		—		37,745
US government agency securities due within one year (Level 2)		24,691		11		—		24,702
Total marketable securities		62,402		45		—		62,447

Note 5. Fair Value Measurements

As of September 30, 2025 and December 31, 2024, the Company’s financial liabilities recognized at fair value on a recurring basis consisted of the following:


	As at September 30, 2025
(In thousands of USD)	Level 1		Level 2		Level 3		Total
Derivative warrant liability (Public Warrants)		41,504		—		—		41,504
Derivative warrant liability (Private Placement Warrants)		—		2,857		—		2,857
Derivative earnout liability		—		—		—		—
Total financial liabilities		41,504		2,857		—		44,361


	As at December 31, 2024
(In thousands of USD)	Level 1		Level 2		Level 3		Total
Derivative warrant liability (Public Warrants)		35,134		—		—		35,134
Derivative warrant liability (Private Placement Warrants)		—		2,380		—		2,380
Derivative earnout liability		—		—		44,798		44,798
Total financial liabilities		35,134		2,380		44,798		82,312

The estimated fair value of the derivative earnout liability 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 derivative earnout liability has 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 liability 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:


	At settlement			December 31, 2024
Ordinary Share value (USD)	$	23.41		$	25.70
Probability of milestone completion		100	%		100	%
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 valuation dates.

The following table presents a reconciliation of the derivative earnout liability measured on a recurring basis using Level 3 inputs as of September 30, 2025:

In March 2025 it was determined that the earnout milestone triggering event set forth in the Business Combination Agreement, dated July 25, 2022 (the “Business Combination Agreement”), by and among the Company, NewAmsterdam Pharma Holding B.V., Frazier Lifesciences Acquisition Corporation (“FLAC”), and NewAmsterdam Pharma Investment Corporation (the “Business Combination”) had occurred. As a result, the derivative earnout liability was settled in full, with a total of 1,743,136 Ordinary Shares issued in accordance with the terms of the Business Combination Agreement.

Note 6. Prepayments and Other Receivables

Prepayments and other receivables consisted of the following:


(In thousands of USD)	September 30, 2025		December 31, 2024
Prepaid research and development costs		6,330		5,704
Other prepaid expenses		1,495		2,214
License fee receivable		16,144		14,285
Value added tax receivable		206		321
Other receivables		3,899		1,748
Total prepayments and other receivables		28,074		24,272

Note 7. Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following:


(in thousands of USD)	September 30, 2025		December 31, 2024
Accrued research and development materials and services		2,147		2,069
Accrued compensation and benefits		5,870		8,721
Accrued professional fees and other		2,081		2,818
Total accrued expenses and other current liabilities		10,098		13,608

Note 8. Shareholders’ Equity

At-the-Market Offering

On August 9, 2024, we entered into an amended and restated sales agreement (the “Sales Agreement”) with TD Securities (USA) LLC (“TD Cowen”), pursuant to which we may issue and sell from time to time up to $250 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 nine months ended September 30, 2025, we did not sell any Ordinary Shares pursuant to the Sales Agreement.

Issuance of Earnout Shares

In March 2025, it was determined that the earnout milestone triggering event set forth in the Business Combination Agreement had occurred and, as a result, a total of 1,743,136 Ordinary Shares were issued in accordance with the terms of the Business Combination Agreement.

Employee Receivables Due Upon Exercise of Company Options

As of December 31, 2024, the amount reported on the consolidated balance sheet for employee receivables included amounts which were due to the Company for Company Options (as defined below) which had been exercised, but for which the exercise price had not yet been remitted. All such receivables were paid during January and February 2025.

Note 9. Share-Based Compensation

The Company has four Share-based payment plans and one restricted share award in place as at September 30, 2025:

•

The Company’s Long-Term Incentive Plan (the “LTIP Plan”);

•

The Company’s Supplementary Long-Term Incentive Plan (the “Supplementary Plan”);

•

The Company’s Rollover Option Plan (the “Rollover Plan”);

•

The Company’s Inducement Plan (the “Inducement Plan,” together with the LTIP Plan, the Supplementary Plan and the Rollover Plan, the “Plans”); and

•

Chief Executive Officer Restricted Share Award.

The 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 September 30, 2025, a maximum of 28,435,355 Ordinary Shares may be reserved for issuance pursuant to the Plans. The number of Ordinary Shares reserved for grant under the LTIP 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 Company's Board of Directors.

The contractual term is 10 years from grant date for options granted under the Plans. In general, each Company Option 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.

In general, each RSU, other than the Earnout RSUs, has a three-year vesting period with one-third vesting on each one-year anniversary of the vesting start date.

The changes for the nine months ended September 30, 2025 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, 2024		19,029,056		$	10.04
Granted		4,696,058		$	24.35
Exercised		(1,888,401	)	$	6.43
Forfeited		(63,961	)	$	21.42
Outstanding as at September 30, 2025		21,772,752		$	13.43		7.8		326,817
Options exercisable as at September 30, 2025		10,100,693		$	9.24		7.1		193,898

The weighted average grant date fair value of Company Options, estimated as of the grant date using the Black-Scholes option pricing model, was $12.54, and $6.60 per option for options granted during the nine months ended September 30, 2025 and 2024, respectively. The total intrinsic value (the amount by which the fair market value exceeded the exercise price) of Company Options exercised during the nine months ended September 30, 2025 and 2024 was $30.3 million and $8.7 million, respectively. Weighted average assumptions used to apply this pricing model were as follows:


	Nine months ended September 30,
	2025			2024
Expected term (years)		6.1			6.1
Risk-free interest rate		4.3	%		3.9	%
Expected volatility		47.6	%		41.7	%
Expected dividend yield		0.0	%		0.0	%

Expected Term

The expected term represents the period that the Company Options 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 Options.

Expected Volatility

Since the Company was privately held through November 2022, it alone does not have sufficient relevant company-specific historical data to support its expected volatility alone. In prior periods, due to the insufficiency of historical volatility data on the Company’s own securities, the expected volatility input was determined using comparable companies alone. Beginning on January 1, 2024 expected volatility input was determined using a weighted average calculation considering the volatility of the Company’s own securities and the volatilities of a representative group of publicly traded biopharmaceutical companies over a period equal to the expected term of the stock option grants. Initially, the volatility of the Company’s Ordinary Shares is assigned a weighting of 10%. This weighting will be increased by 5% per calendar quarter (i.e. 40% in Q3 2025), until the expected volatility input is based entirely on the historical volatility of the Company’s Ordinary Shares. 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 term of the Company Options.

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 Company Options.

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 term of the Company Options.

Expected Dividend Yield

The expected dividend yield is zero as the Company currently has no history or expectation of declaring dividends on its Ordinary Shares.

Restricted Stock Units

As at December 31, 2024 the Company had allocated 143,002 Earnout Shares to be granted to Participating Optionholders if and when a certain clinical development milestone is achieved during the earnout period. In March 2025 it was determined that the earnout milestone triggering event set forth in the Business Combination Agreement had occurred and, as a result, Earnout Shares were delivered in the form of awards of RSUs (the “Earnout RSUs”) granted pursuant to the LTIP Plan to such Participating Optionholders who were, at the time of achievement of such milestone, still providing services to the Company. In total, 143,001 Earnout RSUs were granted, all of which have vested as of September 30, 2025. Though the Earnout RSUs were only legally granted upon the achievement of the milestone triggering event, in accordance with ASC 718, the Company determined the grant date of such Earnout RSUs to be November 22, 2022 for accounting purposes and began recognizing the associated share-based compensation expenses once the milestone was deemed probable to occur.

The changes for the nine months ended September 30, 2025 in the number of RSUs outstanding are as follows:


	Number of RSUs			Weighted average fair value per share
Outstanding as at December 31, 2024		143,002		$	9.84
Granted		729,444		$	25.14
Vested		(143,001	)	$	9.84
Forfeited/Cancelled		(4,537	)	$	25.96
Outstanding as at September 30, 2025		724,908		$	25.14

The following summarizes the share-based compensation expense recognized by type of award and line-item:


	Three months ended September 30,				Nine months ended September 30,
(in thousands of USD)	2025		2024		2025		2024
Share-based compensation expense by type of award
Share options		12,222		7,996		37,312		24,204
Restricted stock units		2,788		—		8,090		—
Total share-based compensation expense		15,010		7,996		45,402		24,204
Share-based compensation expense by line-item
Research and development expenses		4,979		3,043		15,310		9,514
Selling, general and administrative expenses		10,031		4,953		30,092		14,690
Total share-based compensation expense		15,010		7,996		45,402		24,204

As of September 30, 2025, there was $48.0 million and $10.3 million of unrecognized compensation cost related to Company Options and RSUs that have not yet vested, respectively. These costs are expected to be recognized over a weighted average period of 3.0 years and 2.3 years until fully vested for the Company Options and RSUs, respectively.

Note 10. Segment Information

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.

To date, our license agreement with Menarini, dated June 23, 2022, as amended (the "Menarini License") and the Menarini Supply Agreement have been the only sources of revenue to the Company and all such revenues derive from Italy.

The chief operating decision maker assesses performance and decides how to allocate resources based on consolidated net loss and loss before tax, adjusted for certain non-cash and non-operating items such as share-based compensation, change in fair value of derivatives and foreign currency gains or losses. Adjusted loss before taxes is used to monitor budget versus actuals and evaluate the operations of the Company. The measure of segment assets is reported on the balance sheet as total consolidated assets. The future prospects of the Company are highly dependent upon the results of its ongoing clinical trials and interactions with regulatory agencies. Such results and interactions are utilized together with assessment of the comparison of budget versus actuals in order to make decisions regarding the allocation of resources.

The following table presents the adjusted loss before taxes for the Company's single segment for each of the three and nine months ended September 30, 2025 and 2024:


	Three months ended September 30,						Nine months ended September 30,
(In thousands of USD)	2025			2024			2025			2024
Revenue		348			29,111			22,471			32,791
Interest income		6,713			4,443			21,119			12,396
Less:
Personnel expense		10,352			8,943			30,415			21,229
External R&D expense		19,075			24,824			62,979			85,877
Manufacturing expense		3,191			4,612			13,321			12,550
Regulatory expense		1,092			819			3,134			1,719
Commercial programs		3,889			3,055			15,192			9,294
General and administrative expense		2,757			3,776			11,386			10,792
Depreciation and amortization		125			89			345			186
Segment adjusted loss before tax		(33,420	)		(12,564	)		(93,182	)		(96,460	)
Reconciliation to consolidated net loss
Share-based compensation expense		(15,010	)		(7,996	)		(45,402	)		(24,204	)
Change in fair value - derivatives		(23,792	)		(770	)		(3,448	)		(30,028	)
Loss on disposal of property, plant and equipment		(1	)		—			(1	)		—
Foreign exchange gains/(losses)		218			4,682			13,137			1,270
Income tax (expense)/benefit		—			1			—			1
Consolidated net loss for the period		(72,005	)		(16,647	)		(128,896	)		(149,421	)

Note 11. Net Loss per Ordinary Share

For the purposes of calculating the weighted-average number of Ordinary Shares outstanding, the Ordinary Shares underlying the pre-funded warrants to purchase Ordinary Shares (the “Pre-Funded Warrants”) issued in the February 2024 follow-on offering and the December 2024 follow-on offering are included.

Basic and diluted net loss per Ordinary Share was calculated as follows:


	Three months ended September 30,						Nine months ended September 30,
(In thousands of USD, except share and per share amounts)	2025			2024			2025			2024
Net loss		(72,005	)		(16,647	)		(128,896	)		(149,421	)
Weighted average Ordinary Shares outstanding, basic and diluted		119,000,266			94,754,140			117,904,432			92,666,874
Net loss per Ordinary Share, basic and diluted		(0.61	)		(0.18	)		(1.09	)		(1.61	)

The following potentially dilutive securities have been excluded from the computation of diluted weighted-average Ordinary Shares outstanding as they would be anti-dilutive:


	As at September 30,
	2025		2024
Stock options		21,772,752		20,180,954
Restricted stock units		724,908		—
Outstanding warrants		2,592,713		2,700,152
Total		25,090,373		22,881,106

Note 12. Commitments and Contingencies

Commitments

The Company has entered into a variety of agreements and 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 the Company with the option to cancel, reschedule and adjust its requirements based on the Company's business needs, prior to the delivery of goods or performance of services. Payments due upon cancellation generally consist only of payments for services provided or expenses incurred, including non-cancellable obligations of the Company's service providers, up to the date of cancellation. However, some of the Company's service providers also charge cancellation fees upon cancellation. The amount and timing of such payments are not known, but at September 30, 2025 they are estimated to be a maximum of $39.4 million.

According to the terms of the Menarini License the Company will be responsible for development and commercialization costs related to Licensed Products (as defined in the Menarini License) other than those in the Menarini Territory (as defined in the Menarini License). In addition, under specified conditions of the agreement, the Company 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 13. 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.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report, and this Management’s Discussion and Analysis of Financial Condition and Results of Operations should be read together with our audited financial statements and accompanying notes for the year ended December 31, 2024, included in our Annual Report on Form 10-K (the "Annual Report"), filed with the U.S. Securities and Exchange Commission (the “SEC”) on February 26, 2025, and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations. In addition to historical financial information, the following discussion contains forward-looking statements that reflect our plans, estimates and beliefs. Our actual results could differ materially from those contained in or implied by any forward-looking statements. Factors that could cause or contribute to these differences include those discussed in the sections titled “Risk Factors” and “Special Note Regarding Forward-Looking Statements” in the Annual Report and this Quarterly Report. Our operating results are not necessarily indicative of results that may occur for the full fiscal year or any other future period.

Overview

We are a late-stage biopharmaceutical company whose mission is to improve patient care in populations with cardiometabolic diseases where currently approved therapies have not been adequate or well tolerated. We seek to fill a significant unmet need for a safe, well tolerated and convenient low-density lipoprotein cholesterol (“LDL-C”) lowering therapy. In multiple Phase 3 trials, we have investigated obicetrapib, an oral, low-dose, once-daily, highly selective cholesteryl ester transfer protein (“CETP”) inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of cardiovascular disease (“CVD”) with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated. We believe that CETP inhibition may also play a role in other indications by potentially mitigating the risk of developing diseases such as Alzheimer’s disease (“AD”).

Obicetrapib is a next-generation, oral, low-dose, highly selective CETP inhibitor that we are developing to potentially overcome the limitations of current LDL-C lowering treatments. In addition to LDL-C, in clinical trials obicetrapib has shown significant reductions in lipoprotein (a) (“Lp(a)”) and small LDL particles, all with safety comparable to placebo. We believe that obicetrapib has the potential to be a once-daily oral CETP inhibitor for lowering LDL-C, if approved. In each of our Phase 3 clinical trials, BROADWAY and BROOKLYN, evaluating obicetrapib as an adjunct to high-intensity statin therapy, obicetrapib met its primary and secondary endpoints, with statistically significant reductions in LDL-C observed. In our Phase 3 TANDEM clinical trial, evaluating obicetrapib in combination with ezetimibe as an adjunct to high-intensity statin therapy, obicetrapib in combination with ezetimibe met its primary and secondary endpoints, with statistically significant reductions in LDL-C observed. In five of our Phase 2 clinical trials, TULIP, ROSE, OCEAN, ROSE2 and our Japan Phase 2b clinical trial, evaluating obicetrapib as a monotherapy or a combination therapy with ezetimibe 10 mg, we observed statistically significant LDL-C lowering with side effects similar in frequency and severity to placebo including muscle-related side effects and drug-related treatment emergent serious adverse events. We have observed obicetrapib to be well tolerated in an aggregate of over 3,500 patients with low or moderately elevated LDL-C levels (“dyslipidemia”) in our clinical trials to date. Furthermore, we believe that obicetrapib’s oral delivery, demonstrated activity at low doses, chemical properties and tolerability make it well-suited for combination approaches.

Lowering of LDL-C, has been associated with major adverse cardiovascular events (“MACE”) benefit in trials of LDL-C lowering drugs, including the REVEAL trial with the CETP inhibitor, anacetrapib. In our Phase 3 BROADWAY clinical trial we observed a 21% reduction in the exploratory MACE endpoint (coronary heart disease death, non-fatal myocardial infarction, non-fatal stroke and coronary revascularization) and we are performing a Phase 3 cardiovascular outcomes trial (“CVOT”), PREVAIL, to reconfirm this relationship. We completed enrollment in PREVAIL in April 2024. PREVAIL will continue until the last participant has been followed for a minimum of 2.5 years and the target number of MACE events have occurred. As a result, the earliest the trial could conclude based on the minimum follow-up period is the end of 2026. However, we will continue the trial until the target number of MACE events occur, which could likely require the trial to continue beyond this point.

In our clinical trials, obicetrapib has not only reduced LDL-C but also several additional biomarkers associated with MACE including non-HDL-C, apolipoprotein B, and small dense lipoprotein particles. We have also observed reductions in Lp(a), which is believed to be an independent MACE risk factor, along with reductions in total lipoprotein (“LDL”) particles and more specifically small LDL particles, which are believed to be more atherogenic particles.

CVD is a leading cause of death worldwide. Atherosclerotic cardiovascular disease (“ASCVD”) is primarily caused by atherosclerosis, which involves the build-up of fatty material within the inner walls of the arteries. Atherosclerosis is the primary cause of heart attacks, strokes and peripheral vascular disease. One of the most important risk factors for ASCVD is hypercholesterolemia, which refers to elevated LDL-C levels within the body, commonly known as high cholesterol.

A significant proportion of patients with high cholesterol do not achieve acceptable LDL-C levels using statin therapy alone. We estimate that in the United States there are approximately 30 million patients that are not at their risk-based LDL-C goals despite treatment with lipid lowering therapy, including approximately 13 million with ASCVD. Existing non-statin treatment options have been largely unable to address the needs of patients with high cholesterol due to limited efficacy, an inconvenient injectable administration route and, in the past, market access restrictions. It is estimated that over 75% of ASCVD and heterozygous familial hypercholesterolemia (“HeFH”) outpatients prefer oral drugs to injectable therapies.

Our goal is to develop and commercialize an LDL-C lowering monotherapy and a fixed-dose combination therapy, which offers the advantage of a single, low dose, once-daily oral pill, and fulfills the significant unmet need for an effective and convenient LDL-C lowering therapy. If we obtain marketing approval, we intend to commercialize obicetrapib for patients with ASCVD and/or HeFH and elevated levels of LDL-C despite being treated with currently available optimal lipid lowering therapy.

We have partnered with A. Menarini International Licensing S.A. ("Menarini"), providing them with the exclusive rights to commercialize obicetrapib 10 mg, either as a sole active ingredient product or in a fixed-dose combination with ezetimibe, in the majority of European countries, if approved. Subject to receipt of marketing approval, our current plan is to pursue development and commercialization of obicetrapib in the United States ourselves, and to consider additional partners for jurisdictions outside of the United States and the European Union (the “EU”), including in Japan and China. In addition to our partnership with Menarini, we may in the future utilize a variety of types of collaboration, license, monetization, distribution and other arrangements with other third parties relating to the development or commercialization, once approved, of obicetrapib or future product candidates or indications. We are also continually evaluating the potential acquisition or license of new product candidates.

Third Quarter Highlights

Acceptance of Marketing Authorization Applications for Review by European Medicines Agency for Obicetrapib

On August 18, 2025 we announced that the European Medicines Agency (“EMA”) validated the Marketing Authorization Applications (“MAAs”) for obicetrapib 10 mg monotherapy and 10 mg obicetrapib plus 10 mg ezetimibe fixed-dose combination (“FDC”) for patients with primary hypercholesterolemia, both HeFH and non-familial or mixed dyslipidemia. The MAAs were submitted by our partner, Menarini, who is responsible for communications with regulatory authorities in Europe and for the commercialization and local development of obicetrapib in Europe and other collaborative activities pursuant to an exclusive license agreement with us (the "Menarini License").

Menarini Supply Agreement

On August 12, 2025, we entered into a Supply Agreement with Menarini as contemplated by the Menarini License. Under the terms of the Supply Agreement, we agreed to supply Menarini with obicetrapib monotherapy and obicetrapib plus ezetimibe fixed-dose combination finished products in bulk tablet form (the “Drug Products”). We will initially be Menarini’s exclusive supplier of the Drug Products. The price to be paid by Menarini will be based on a specified mark-up to our “cost of goods sold” for the supplied Drug Products as determined in accordance with the Supply Agreement, subject to periodic adjustments.

The Supply Agreement also provides for the initiation of a process to transfer manufacturing of the Drug Products to Menarini or to a designated third-party contract manufacturer. In connection with the manufacturing transfer, we granted Menarini a non-exclusive, non-transferable license under our patents and know-how to manufacture finished Drug Products.

Components of our Results of Operations

Revenue

To date, we have not generated significant revenue from the sale of pharmaceutical products. Our revenue has been primarily derived from the Menarini License. Two performance obligations for the Menarini License were identified at contract inception, comprising a license to use our intellectual property (the “license performance obligation”) and a promise to continue the development activities for the licensed compound (the “R&D performance obligation”). Pursuant to the Menarini License, we received a non-refundable, non-creditable upfront amount of $120.9 million (€115.0 million) from Menarini on July 7, 2022, of which $98.6 million (€93.5 million) was attributed to the license performance obligation and recognized as revenue upon the execution of the Menarini License on June 23, 2022. The remaining $22.3 million (€21.5 million) was attributed to the R&D performance obligation and initially recognized as deferred revenue. As of September 30, 2025, the R&D performance obligation had been deemed to be completely satisfied and all deferred revenue related to such performance obligation was recognized.

Additionally, in partial contribution to our costs of development of the licensed products, Menarini may pay us €27.5 million, payable in two equal annual installments and attributed entirely to the R&D performance obligation. Due to the scientific uncertainties around the commercialization of the licensed products based on the success of clinical trials, which is out of our control, the fixed €27.5 million was considered constrained at contract execution and was not initially recognized within the transaction price until it becomes highly probable of no significant revenue reversal. As of September 30, 2025, both annual development cost contributions had been recognized within the transaction price.

Under the Menarini License, we are also entitled to receive certain cost sharing payments, sales-based royalties and payments based upon the achievement of defined development, regulatory and commercial milestones linked to the enhanced value of the license performance obligation. These milestones are contingent payments and represent variable considerations 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. Our ability to receive and generate revenue from these payments is dependent upon a number of factors, including our ability to successfully complete the development of and obtain regulatory approval for obicetrapib within the Menarini Territory (as defined in the Menarini License). The uncertainty of achieving these milestones significantly impacts our ability to generate revenue. At the end of each reporting period, we assess the probability of significant reversals for any amounts that become likely to be realized prior to recognizing the variable consideration associated with these payments within the transaction price.

In addition, we entered into the Menarini Supply Agreement to provide commercial supply of Drug Products for distribution by Menarini in specified European territories.

We recognize revenue from the sale of obicetrapib tablets, as a monotherapy and as a FDC therapy with ezetimibe, and from the sale of active pharmaceutical ingredients to Menarini for the manufacturer of such tablets. Our product supply revenue is recognized at a point in time when the performance obligation is satisfied by transferring control of the promised goods or services to the customer and it is probable that we will collect the consideration to which we are entitled. In accordance with the terms of the Menarini Supply Agreement, control of the product is transferred upon the conveyance of title, which occurs when the product is made available to Menarini. The transaction price is contractually fixed at a markup of the actual cost of goods sold. Due to the cost-based nature of the agreement, the pricing structure includes a variable component which is measured using the expected value method. At each reporting period end, we update our estimate of the transaction price using actual cost data and forecasted expenses. We state revenues net of any taxes collected from customers that are required to be remitted to various government agencies.

Any revenue generated from potential future collaborations or product sales may vary due to the many uncertainties in the development of obicetrapib and other factors.

Research and Development Expenses

Research and development expenses are recognized as an expense when incurred and are typically made up of costs from our clinical and preclinical activities, drug development and manufacturing costs, and costs for contract research organizations (“CROs”) 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 provided by vendors of their actual costs incurred. At each balance sheet date, we estimate the level of services provided by vendors and the associated expenditure incurred for the services performed.

All such costs are for the purpose of advancing our product candidates to successfully complete clinical development, attain regulatory approval and, if approved, commercialize our product candidates. Much of our current focus in our ongoing trials is on patient recruitment and retention and data cleaning. Research and development expenses consist of the following:

•

clinical expenses primarily incurred by CROs assisting with our sponsored clinical trials and including clinical investigator costs, patient enrollments and costs of clinical sites;

•

manufacturing expenses arising from investments in commercial manufacturing capabilities and active pharmaceutical ingredient and drug product development as performed by our contract manufacturing organizations (“CMOs”);

•

costs associated with obtaining potential regulatory approval of our product candidates, including preparation and submission of filings, ongoing monitoring and compliance with comments and recommendations provided by regulatory authorities, and regulatory-related advisory fees;

•

contracted personnel and employment costs attributed to research and development efforts, which includes management fees, salaries, share-based compensation expenses, bonus plans and payments to contractors who work for us for a fixed number of hours per week or per month;

•

preclinical and nonclinical research and development expenses of our product candidates; and

•

other clinical costs such as clinical trial insurance and other consultancy fees.

We expect our research and development expenses to be significant as we advance our product candidates through clinical trials and pursue regulatory approval. The process of conducting the necessary clinical trials to obtain regulatory approval is costly and time-consuming. Clinical trials generally become larger and more costly to conduct as they advance into later stages and, in the future, we will be required to make estimates for expense accruals related to clinical trial expenses. At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of obicetrapib as a monotherapy and as a fixed-dose combination with ezetimibe. See the section entitled “Risk Factors—Risks Related to Our Product Development, Regulatory Approval and Commercialization” contained in the Annual Report for more information regarding the risks associated with clinical development.

Selling, General and Administrative Expenses

We recognize selling, general and administrative expenses on the accrual basis when incurred. These expenses mainly relate to consultant fees, employee costs, legal costs, marketing and communication, intellectual property costs related to drug patent development and protection globally, and general overhead costs.

Due to the general growth of the organization associated with administering ongoing and planned clinical trials and our focus on commercial preparedness, we expect that our selling, general and administrative expenses may increase. We will incur increased accounting, audit, legal, regulatory, compliance, director and officer insurance costs as well as investor and public relations expenses associated with being a public company. Additionally, if and when a regulatory approval of a product candidate appears likely, we anticipate an increase in payroll and expenses as a result of our preparation for commercial operations.

Interest Income

Interest income is recognized using the effective interest rate method. Interest income for the three and nine months ended September 30, 2025 and 2024 is related to interest earned on cash, cash equivalents and marketable securities.

Net Foreign Exchange Gain/Loss

Our exchange gain relates mainly to cash balances denominated in foreign currencies, but also to transactions denominated in foreign currencies. Our foreign currency exposure is mainly related to the Euro. As of September 30, 2025, our net exposure to foreign currency risk was $112.8 million, as compared to $108.6 million as of December 31, 2024.

Income Tax

We have a history of losses and therefore have de minimis amounts of corporate tax. We expect to continue incurring losses as we continue to invest in our clinical and preclinical development programs. Consequently, any deferred tax assets are fully offset by a valuation allowance on our balance sheet.

Results of Operations

Comparison of the three months ended September 30, 2025 and 2024

The following table summarizes our consolidated statements of operations for the periods indicated:


	For the three months ended September 30,
(In thousands of USD)	2025			2024			Change
Revenue		348			29,111			(28,763	)
Operating Expenses:
Research and development expenses		30,971			35,702			(4,731	)
Selling, general and administrative expenses		24,520			18,412			6,108
Total operating expenses		55,491			54,114			1,377
Operating Loss		(55,143	)		(25,003	)		(30,140	)
Other income (expense):
Interest Income		6,713			4,443			2,270
Fair value change - earnout		—			(5,414	)		5,414
Fair value change - warrants		(23,792	)		4,644			(28,436	)
Loss on disposal of fixed assets		(1	)		—			(1	)
Foreign exchange gains/(losses)		218			4,682			(4,464	)
Loss before tax		(72,005	)		(16,648	)		(55,357	)
Income tax expense		—			(1	)		1
Loss for the period		(72,005	)		(16,647	)		(55,358	)

Revenue

Revenue was $0.3 million for the three months ended September 30, 2025 compared to $29.1 million for the three months ended September 30, 2024, a decrease of $28.8 million, or 99%. This decrease is largely due to the recognition of $27.3 million of revenue from the Menarini License related to a clinical development milestone which was earned in the three months ended September 30, 2024 while there were no clinical milestones earned in the three months ended September 30, 2025.

Research and Development Expenses

Research and development expenses were $31.0 million for the three months ended September 30, 2025 compared to $35.7 million for the three months ended September 30, 2024, a decrease of $4.7 million, or 13%. This was primarily driven by:

•

a $6.6 million decrease in clinical expenses mainly due to the completion of several Phase 3 clinical trials in the second half of 2024 and cost phasing in ongoing clinical trials; and

•

a $1.4 million decrease in manufacturing costs mainly driven by the completion of certain investments in commercial manufacturing capabilities during the current period;

partially offset by:

•

a $2.2 million increase in personnel expenses related to research and development activities primarily driven by our share-based compensation arrangements which account for $1.9 million of the increase; and a $0.7 million increase in non-clinical expenses due to greater activity related to pipeline expansion and product lifecycle management.

•

The following table summarizes our research and development expenses for the periods indicated:


	For the three months ended September 30,
(In thousands of USD)	2025		2024		Change
Clinical expenses		17,447		24,083		(6,636	)
Non-clinical expenses		1,428		707		721
Personnel expenses		7,624		5,448		2,176
Manufacturing costs		3,186		4,612		(1,426	)
Regulatory expenses		1,093		819		274
Other research and development costs		193		33		160
Total research and development expenses		30,971		35,702		(4,731	)

Selling, General and Administrative Expenses

Selling, general and administrative expenses were $24.5 million for the three months ended September 30, 2025 compared to $18.4 million for the three months ended September 30, 2024, an increase of $6.1 million or 33%. This was primarily driven by a $6.3 million increase in personnel expenses related to selling, general and administrative activities primarily driven by our share-based compensation arrangements which account for $5.1 million of the increase. The remainder was largely due to increased recruitment and employment costs for individuals involved with administrative and commercial preparedness activities to support the growth of the organization and operation as a public company.

Interest Income

Interest income was $6.7 million for the three months ended September 30, 2025 compared to $4.4 million for the three months ended September 30, 2024, an increase of $2.3 million or 52%. This increase was largely driven by an increase in the amount of cash, cash equivalents and marketable securities on which interest was earned.

Fair Value Change - Earnout

Fair value change - earnout was nil for the three months ended September 30, 2025 compared to a loss of $5.4 million for the three months ended September 30, 2024. The earnout liability was settled in full in March 2025.

Fair Value Change - Warrants

Fair value change - warrants was a loss of $23.8 million for the three months ended September 30, 2025 compared to a gain of $4.6 million for the three months ended September 30, 2024. The change is driven by changes in the market price of the warrants trading under the symbol “NAMSW” (the “Warrants”) during the period.

Foreign Exchange Gains/(Losses)

Net foreign exchange gains/(losses) were a gain of $0.2 million for the three months ended September 30, 2025 compared to a gain of $4.7 million for the three months ended September 30, 2024. This change was largely driven by movements in the exchange rate for Euros which is our primary foreign currency exposure.

Loss for the Period

Loss for the period was $72.0 million for the three months ended September 30, 2025 compared to $16.6 million for the three months ended September 30, 2024, an increase of $55.4 million. The individual components of the change are described above.

Comparison of the nine months ended September 30, 2025 and 2024

The following table summarizes our consolidated statements of operations for the periods indicated:


	For the nine months ended September 30,
(In thousands of USD)	2025			2024			Change
Revenue		22,471			32,791			(10,320	)
Operating Expenses:
Research and development expenses		103,238			116,511			(13,273	)
Selling, general and administrative expenses		78,936			49,340			29,596
Total operating expenses		182,174			165,851			16,323
Operating Loss		(159,703	)		(133,060	)		(26,643	)
Other income (expense):
Interest Income		21,119			12,396			8,723
Fair value change - earnout		3,992			(11,020	)		15,012
Fair value change - warrants		(7,440	)		(19,008	)		11,568
Loss on disposal of fixed assets		(1	)		—			(1	)
Foreign exchange gains/(losses)		13,137			1,270			11,867
Loss before tax		(128,896	)		(149,422	)		20,526
Income tax expense		—			(1	)		1
Loss for the period		(128,896	)		(149,421	)		20,525

Revenue

Revenue was $22.5 million for the nine months ended September 30, 2025 compared to $32.8 million for the nine months ended September 30, 2024, a decrease of $10.3 million, or 31%. This decrease was largely due to the recognition of $27.3 million of revenue from the Menarini License related to a clinical development milestone which was earned in the nine months ended September 30, 2024 while there were no clinical milestones earned in the three months ended September 30, 2025. The decrease in revenue related to clinical development milestones pursuant to the Menarini License was partially offset by the recognition of $16.1 million of revenue in the current period related to the second installment of development cost contributions under the Menarini License.

Research and Development Expenses

Research and development expenses were $103.2 million for the nine months ended September 30, 2025 compared to $116.5 million for the nine months ended September 30, 2024, a decrease of $13.3 million, or 11%. This was primarily driven by:

•

a $29.7 million decrease in clinical expenses mainly due to the completion of several Phase 3 clinical trials in the second half of 2024 and cost phasing in ongoing clinical trials;

partially offset by:

•

a $7.5 million increase in personnel expenses related to research and development activities primarily driven by our share-based compensation arrangements which accounted for $5.8 million of the increase;

•

a $6.8 million increase in non-clinical expenses due to greater activity related to pipeline expansion and product lifecycle management;

•

a $1.4 million increase in regulatory expenses primarily driven by the preparation and planned submission of regulatory applications for obicetrapib; and

•

a $0.8 million increase in manufacturing expenses driven by investments in commercial manufacturing capabilities.

The following table summarizes our research and development expenses for the periods indicated:


	For the nine months ended September 30,
(In thousands of USD)	2025		2024		Change
Clinical expenses		54,426		84,174		(29,748	)
Non-clinical expenses		8,291		1,503		6,788
Personnel expenses		23,815		16,366		7,449
Manufacturing costs		13,316		12,550		766
Regulatory expenses		3,135		1,719		1,416
Other research and development costs		255		199		56
Total research and development expenses		103,238		116,511		(13,273	)

Selling, General and Administrative Expenses

Selling, general and administrative expenses were $78.9 million for the nine months ended September 30, 2025 compared to $49.3 million for the nine months ended September 30, 2024, an increase of $29.6 million or 60%. This was primarily driven by:

•

a $22.9 million increase in personnel expenses related to selling, general and administrative activities primarily driven by our share-based compensation arrangements which accounted for $15.4 million of the increase. The remainder was largely due to increased recruitment and employment costs for individuals involved with administrative and commercial preparedness activities to support the growth of the organization and operation as a public company;

•

a $4.6 million increase in marketing and communication expenses related to startup costs as we began to build capabilities to support our planned commercial launch of obicetrapib, if approved; and

•

a $1.4 million increase in costs related to our intellectual property primarily driven by worldwide patent filings.

Interest Income

Interest income was $21.1 million for the nine months ended September 30, 2025 compared to $12.4 million for the nine months ended September 30, 2024, an increase of $8.7 million or 70%. This increase was largely driven by an increase in the amount of cash, cash equivalents and marketable securities on which interest was earned.

Fair Value Change - Earnout

Fair value change - earnout was a gain of $4.0 million for the nine months ended September 30, 2025 compared to a loss of $11 million for the nine months ended September 30, 2024. The change was driven by changes in the market price for ordinary shares which trade under the symbol “NAMS” (the “Ordinary Shares”) prior to the settlement of the earnout liability, which occurred in March 2025.

Fair Value Change - Warrants

Fair value change - warrants was a loss of $7.4 million for the nine months ended September 30, 2025 compared to a loss of $19 million for the nine months ended September 30, 2024. The change was driven by changes in the market price of the Warrants during the period.

Foreign Exchange Gains/(Losses)

Net foreign exchange gains/(losses) were a gain of $13.1 million for the nine months ended September 30, 2025 compared to a gain of $1.3 million for the three months ended September 30, 2024. This change was largely driven by movements in the exchange rate for Euros which is our primary foreign currency exposure.

Loss for the Period

Loss for the period was $128.9 million for the nine months ended September 30, 2025 compared to $149.4 million for the nine months ended September 30, 2024, a decrease of $20.5 million. The individual components of the change are described above.

Liquidity and Capital Resources

Overview

To date, we have devoted substantially all of our resources to organizing and staffing our company, business planning, raising capital, undertaking preclinical studies and conducting clinical trials of obicetrapib. As a result, we are not yet profitable and have incurred losses in each annual period since our inception. As of September 30, 2025, we had an accumulated loss of $687.5 million. We expect to continue to incur significant losses for the foreseeable future.

We have historically funded our operations primarily through private and public placements of shares, the sale of convertible notes, proceeds from the Menarini License and the proceeds from the closing of the transactions contemplated by the Business Combination Agreement. As of September 30, 2025, we had cash, cash equivalents and marketable securities of $756.0 million.

Sources of Liquidity

December 2024 Follow-on Offering

On December 13, 2024, we completed an underwritten public offering (the “December 2024 Offering”) of 14,667,347 Ordinary Shares at a public offering price of $24.50 per Ordinary Share and, in lieu of Ordinary Shares to certain investors, Pre-Funded Warrants to purchase 4,882,653 Ordinary Shares at a public offering price of $24.4999 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 14,667,347 Ordinary Shares issued and sold in the December 2024 Offering, 2,550,000 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 net proceeds to the Company from the December 2024 Offering were $453.4 million after deducting underwriting discounts and commissions and offering expenses payable by the Company.

February 2024 Follow-on Offering

On February 16, 2024, we completed an underwritten public offering (the “February 2024 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 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 February 2024 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 net proceeds to the Company from the February 2024 Offering were $190.0 million after deducting underwriting discounts and commissions and offering expenses payable by the Company.

At-the-Market Offering

On August 9, 2024, we entered into an amended and restated 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 $250 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 nine months ended September 30, 2025, we did not sell any Ordinary Shares pursuant to the Sales Agreement.

Menarini License

On June 23, 2022, we entered into the Menarini License, pursuant to which we granted Menarini an exclusive, royalty-bearing, sublicensable license under certain of our intellectual property and our regulatory documentation to undertake post approval development activities and commercialize the Licensed Products (as defined in the Menarini License), for any use in the Menarini Territory (as defined in the Menarini License). Pursuant to the Menarini License, Menarini made a non-refundable, non-creditable upfront payment to us of €115 million. Menarini has also committed to providing us €27.5 million in funding for the research and development activities related to the Licensed Products over two years, together with bearing 50% of any development costs incurred in respect of the pediatric population in the Menarini Territory. We are also eligible to receive up to €863 million upon the achievement of various clinical, regulatory and commercial milestones.

If obicetrapib is approved, and successfully commercialized by Menarini, we will be entitled to tiered royalties ranging from the low double-digits to the mid-twenties as a percentage of net sales in the Menarini Territory, with royalty step-downs in the event of generic entrance or in respect of required third-party intellectual property payments. See the section entitled “Business—Commercial” contained in our Annual Report for a full description of the Menarini License.

As of September 30, 2025, we have received a total of €30.0 million and €13.8 million in milestone payments and R&D cost reimbursements, respectively, from Menarini, including €13.8 million which was received in the nine months ended September 30, 2025.

Warrants

In the nine months ended September 30, 2025, 39,868 Warrants were exercised at an exercise price of $11.50 per Ordinary Share generating gross proceeds of $0.5 million. As of September 30, 2025, we had another 2,592,713 outstanding Warrants to purchase 2,592,713 Ordinary Shares, exercisable at an exercise price of $11.50 per share, which expire on November 23, 2027, at 5:00 p.m., Eastern Standard Time. Based on the exercise price of the Warrants, we may receive up to $29.8 million assuming the exercise of all Warrants outstanding as of September 30, 2025. The exercise of the Warrants, and any proceeds we may receive from their exercise, are highly dependent on the price of our Ordinary Shares and the spread between the exercise price of the Warrant and the price of an Ordinary Share at the time of exercise. For example, to the extent that the trading price of the Ordinary Shares exceeds $11.50 per share, it is more likely that holders of our Warrants will exercise their Warrants. If the trading price of the Ordinary Shares is less than $11.50 per share, it is unlikely that such holders will exercise their Warrants. The exercise price of the Warrants has at times exceeded the market price of the Ordinary Shares. To the extent that the price of our Ordinary Shares is below $11.50, we believe that the Warrant holders will be unlikely to cash exercise their warrants, resulting in little to no cash proceeds to us. There can be no assurance that our Warrants will be in the money prior to their expiration and, as such, certain unexercised Warrants may expire worthless. As such, it is possible that we may never generate any additional cash proceeds from the exercise of our Warrants. We have not included, and do not intend to include, any potential cash proceeds from the exercise of our Warrants in our short-term or long-term liquidity projections. We will continue to evaluate the probability that the Warrants are exercised over the life of our Warrants and the merit of including potential cash proceeds from the exercise thereof in our liquidity projections.

Cash Flows

The following is a summary of cash flows for the nine months ended September 30, 2025 and 2024:


	For the nine months ended September 30,
(In thousands of USD)	2025			2024
Net cash used in operating activities		(106,908	)		(121,083	)
Net cash used in investing activities		(153,775	)		(669	)
Net cash provided by financing activities		15,836			202,896
Foreign exchange differences		12,819			1,135
Cash, cash equivalents and restricted cash at the beginning of the period		771,743			340,450
Cash, cash equivalents and restricted cash at the end of the period		539,715			422,729

Net Cash Flows Used In Operating Activities

Net cash flows used in operating activities was $106.9 million in the nine months ended September 30, 2025 compared to $121.1 million in the nine months ended September 30, 2024, a decrease of $14.2 million. This change was primarily due to an increase in interest income and the receipt of the first of two annual development cost contributions due under the Menarini License, partially offset by an increase in operating expenditures.

Net Cash Flows Used In Investing Activities

Net cash flows used in investing activities was $153.8 million in the nine months ended September 30, 2025 compared to $0.7 million in the nine months ended September 30, 2024, a change of $153.1 million. The change was primarily due to our investments in marketable securities of which we had none in the nine months ended September 30, 2024.

During the nine months ended September 30, 2025, purchases of debt securities totaled $225.2 million, partially offset by maturities of debt securities totaling $71.6 million.

Net Cash Flows Provided By Financing Activities

Net cash flows provided by financing activities was $15.8 million in the nine months ended September 30, 2025 compared to $202.9 million in the nine months ended September 30, 2024, a decrease of $187.1 million. This decrease was primarily related to the receipt of proceeds from the February 2024 Offering in the prior year.

Operating Capital and Capital Expenditure Requirements

Third-Party Service Agreements

We have entered into a variety of agreements and financial commitments in the normal course of business with CROs, CMOs, 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 of services. Payments due upon cancellation generally consist only of payments for services provided or expenses incurred, including non-cancelable 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 September 30, 2025 they are estimated to be a maximum of $27.9 million due within one year and $11.4 million due in more than a year. As at September 30, 2025, we had cash and cash equivalents of $538.4 million which is sufficient to fund these obligations.

Leases

We are party to a services agreement (the "Naarden Lease") pursuant to which an affiliate of Forbion leased us office space, an office lease agreement with Renaissance Aventura LLC, dated May 24, 2021, as amended April 9, 2024 (as amended, the “Miami Lease”), and an office sublease agreement with GR8 People, Inc., dated April 2, 2024 (the “Yardley Lease”). Under the Naarden Lease, we are obligated to pay €40 thousand per year in rent. The Naarden Lease will continue until terminated by either us or the landlord. Pursuant to the Miami Lease, we are required to pay annual rent ranging from $75 thousand to $82 thousand, increasing from the low end of the range to the higher end of the range for each year of the lease. The Miami Lease will expire by its terms on October 31, 2027, unless terminated earlier by either party pursuant to the terms of the Miami Lease. Pursuant to the Yardley Lease, we are required to pay annual rent ranging from $189 thousand to $194 thousand, increasing from the low end of the range to the higher end of the range for each year of the lease. The Yardley Lease will expire by its terms on April 3, 2026, unless terminated earlier by either party pursuant to the terms of the Yardley Lease.

Menarini License

We will be responsible for the development and commercialization costs related to Licensed Products (as defined in the Menarini License) other than those in the Menarini Territory (as defined in the Menarini License). 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. See the section entitled “Business—Marketing and Sales” contained in the Annual Report for a description of the Menarini License.

Critical Accounting Policies and Estimates

The preparation of our 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. We based our estimates on historical experience, known trends and other market-specific or other relevant factors that we believe 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 our estimates, or to the extent these estimates are adjusted in future periods, our results of operations could either benefit from, or be adversely affected by, any such change in estimate.

See Note 2 to our consolidated financial statements in the Annual Report and Note 2 to our condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report for a summary of significant accounting policies and the effect on our consolidated financial statements.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

Our principal financial liabilities consist of trade and other payables, lease liabilities and derivative warrant liabilities. The main purpose of these financial liabilities is to finance our day-to-day operations. Our financial assets consist of prepayments and other receivables and cash, that are derived from our operating activities and funding.

We are exposed to market risk, credit risk and liquidity risk. Our senior management oversees the management of these risks. Our Board of Directors (the "Board of Directors") reviews and approves policies for managing each of these risks, which are summarized below.

Market Risk

Market risk is the risk that the fair value or future cash flows of a financial instrument will fluctuate because of changes in market prices. Market risk comprises interest rate risk, foreign currency risk and other price risks.

Interest Rate Risk

We are exposed to interest rate risk primarily through our cash, cash equivalents and marketable securities. Changes in interest rates may cause variations in interest income and expense resulting from short-term interest-bearing assets. We invest in high-quality financial instruments, primarily money market funds and U.S. government and agency securities with maturities of less than one year, which we believe are subject to limited credit risk. We regularly review our investments and monitor the financial markets and we do not currently hedge interest rate exposure. Due to the nature of our investments, we do not believe an immediate 100 basis point change in interest rates would have a material effect on our financial condition. We do not believe that we have any material exposure to interest rate risk or changes in credit ratings arising from our investments.

Foreign Currency Risk

Foreign currency risk is the risk that the fair value or future cash flows of a financial instrument will fluctuate because of changes in foreign exchange rates. Our exposure to the risk of changes in foreign exchange rates relates primarily to cash and trade and other payables denominated in currencies other than our functional currency, the U.S. Dollar. As of September 30, 2025, our net exposure to foreign currency risk was $112.8 million, mainly related to the Euro. As of September 30, 2025, the effect of a hypothetical 1% change in exchange rates on currencies denominated in other than our functional currency would result in a potential change in future earnings in our consolidated statement of operations of approximately $1.1 million.

We partly manage our foreign currency risk by selectively holding foreign currency in our cash to offset foreign currency exposures from lease liabilities and trade and other payables. We plan to use this cash to settle future expenses we expect to incur in those foreign currencies.

Other Market Price Risk

As a result of the Business Combination, we have derivative warrant liabilities, which are measured at fair value through profit or loss. As of September 30, 2025 the fair value of the derivative warrant liabilities totaled $44.4 million. The value of the derivative warrant liability is directly correlated to the market price of a publicly traded Warrant which is traded under the symbol "NAMSW". With all other variables held constant, a 1% change in the market price of NAMSW would change the value of the derivative warrant liability by 1% or $0.4 million.

Credit Risk

Credit risk is the risk that a counterparty will not meet its obligations under a financial instrument or customer contract, leading to a financial loss. We are exposed to credit risk primarily from our treasury activities, including deposits with banks and financial institutions and have limited credit risk exposure from our operating activities. We hold available cash in bank accounts with banks which have investment grade credit ratings. Management periodically reviews the creditworthiness of the banks with which it holds assets.

We perform research and development activities and do not yet have any sales. We are able to reclaim value added tax, which is recoverable from tax authorities. Management periodically reviews the recoverability of the balance of input value added tax and believes it is fully recoverable.

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

We have established disclosure controls and procedures designed to ensure that information required to be disclosed in the reports that we file or submit under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and is accumulated and communicated to management, including our principal executive officer (our Chief Executive Officer) and principal financial officer (our Chief Financial Officer), to allow timely decisions regarding required disclosure.

Our management, under the supervision and with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this Quarterly Report. Management recognizes that any disclosure controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives. Based on such evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of September 30, 2025.

Changes in Internal Controls over Financial Reporting

No change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the three months ended September 30, 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Limitations on the Effectiveness of Controls and Procedures

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.

PART II—OTHER INFORMATION

Item 1. Legal Proceedings.

We are not party to any material pending legal proceedings. From time to time, we may be involved in legal proceedings arising in the ordinary course of business.

Item 1A. Risk Factors

Except as set forth below, there have been no material changes to the risk factors previously disclosed in Part I, "Item 1A. Risk Factors" of our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on February 26, 2025.

Risks Related to Government Regulation

Current and future legislation and executive actions affecting the healthcare industry, including healthcare reform, may impact our business generally and may increase limitations on reimbursement, rebates and other payments, which could adversely affect third-party coverage of our products, our operations and/or how much or under what circumstances healthcare providers will prescribe or administer obicetrapib, if approved.

The United States and some foreign jurisdictions are considering or have enacted a number of legislative and regulatory proposals to change the healthcare system in ways that could affect our ability to sell obicetrapib profitably. Among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality or expanding access. In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives and executive actions.

For example, in March 2010, President Obama signed into law the ACA, a law intended, among other things, to broaden access to health insurance, improve quality of care, and reduce or constrain the growth of healthcare spending. The ACA, among other things, imposed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected, increased the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program, extended the rebate program to individuals enrolled in Medicaid managed care organizations, added a provision to increase the Medicaid rebate for line extensions or reformulated drugs, established annual fees on manufacturers and importers of certain branded prescription drugs and biologic agents, promoted a new Medicare Part D coverage gap discount program, expanded the entities eligible for discounts under the Public Health Service Act pharmaceutical pricing program; and imposed a number of substantial new compliance provisions related to pharmaceutical companies’ interactions with healthcare practitioners. The ACA also expanded eligibility for Medicaid programs and introduced a new Patient Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research and a new Center for Medicare & Medicaid Innovation at the CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending.

Since its enactment, there have been numerous judicial, administrative, executive, and legislative challenges to certain aspects of the ACA. While Congress has not passed comprehensive repeal legislation, several bills affecting the implementation of certain taxes under the ACA have been signed into law. In December 2017, Congress repealed the tax penalty, effective January 1, 2019, for an individual’s failure to maintain ACA-mandated health insurance as part of the Tax Cuts and Jobs Act of 2017 (the “Tax Act”). President Biden issued an Executive Order that instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA. Further, there have been a number of health reform initiatives by the Biden administration that have impacted the ACA. For example, on August 16, 2022, President Biden signed the IRA into law, which sets forth meaningful changes to drug product reimbursement by Medicare. Among other actions, the IRA permits HHS to engage in price-capped negotiation to set the price of certain drugs and biologics reimbursed under Medicare Part B and Part D. The IRA contains statutory exclusions to the negotiation program, including for certain orphan designated drugs for which the only approved indication (or indications) is for the orphan disease or condition. Should our product candidates be approved and covered by Medicare Part B or Part D, and fail to fall within a statutory exclusion, such as that for an orphan drug, those products could, after a period of time, be selected for negotiation and become subject to prices representing a significant discount from average prices to wholesalers and direct purchasers. The IRA also establishes a rebate obligation for drug manufacturers that increase prices of Medicare Part B and Part D covered drugs at a rate greater than the rate of inflation. The inflation rebates may require us to pay rebates if we increased the cost of a covered Medicare Part B or Part D approved product faster than the rate of inflation. In addition, the law eliminates the “donut hole” under Medicare Part D beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and requiring manufacturers to subsidize, through a newly established manufacturer discount program, 10% of Part D enrollees’ prescription costs for brand drugs below the out-of-pocket maximum and 20% once the out-of-pocket maximum has been reached. Our cost-sharing responsibility for any approved product covered by Medicare Part D could be significantly greater under the newly designed Part D benefit structure compared to the pre-IRA benefit design.

Additionally, manufacturers that fail to comply with certain provisions of the IRA may be subject to penalties, including civil monetary penalties. The IRA is anticipated to have significant effects on the pharmaceutical industry and may reduce the prices we can charge and reimbursement we can receive for our products, among other effects.

In addition, other federal health reform measures have been proposed and adopted in the United States since the ACA was enacted. For example, as a result of the Budget Control Act of 2011, providers are subject to Medicare payment reductions of 2% per fiscal year, which went into effect on April 1, 2013. This 2% reduction was temporarily suspended during the COVID-19 pandemic, but has since been reinstated and, unless Congress and/or the Executive Branch take additional action, will begin to increase gradually starting in April 2030, reaching 4% in April 2031, until sequestration ends in October 2031. Further, the American Taxpayer Relief Act of 2012 reduced Medicare payments to several providers and increased the statute of limitations period for the government to recover overpayments from providers from three to five years. The Medicare Access and CHIP Reauthorization Act of 2015 also introduced a quality payment program under which certain individual Medicare providers will be subject to certain incentives or penalties based on new program quality standards. In November 2019, CMS issued a final rule finalizing the changes to the Medicare Quality Payment Program. On May 30, 2018, the Right to Try Act was signed into law. The law, among other things, provides a federal framework for certain patients to access certain investigational new drug products that have completed a Phase 1 clinical trial and that are undergoing investigation for FDA approval. Under certain circumstances, eligible patients can seek treatment without enrolling in clinical trials and without obtaining FDA permission under the FDA expanded access program. There is no obligation for a pharmaceutical manufacturer to make its drug products available to eligible patients as a result of the Right to Try Act.

Additionally, there has been heightened governmental scrutiny in the United States of pharmaceutical pricing practices in light of the rising cost of prescription drugs and biologics. Such scrutiny has resulted in several recent Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs and reform government program reimbursement methodologies for products. At the federal level, the Trump administration used several means to propose or implement drug pricing reform, including through federal budget proposals, executive orders and policy initiatives. For example, on July 24, 2020 and September 13, 2020, the Trump administration announced several executive orders related to prescription drug pricing that attempt to implement several of the administration’s proposals. The FDA also released a final rule, effective November 30, 2020, implementing a portion of the importation executive order providing guidance for states to build and submit importation plans for drugs from Canada. Further, on November 30, 2020, HHS, finalized a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law. The IRA delayed the implementation of the rule to January 1, 2032. The rule also creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a new safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers; the implementation of these provisions has also been delayed by the IRA until January 1, 2032.

On March 11, 2021, President Biden signed the American Rescue Plan Act of 2021 into law, which eliminates the statutory Medicaid drug rebate price cap, currently set at 100% of a drug’s average manufacturer price for single source and innovator multiple source products, beginning on January 1, 2024. Further, in July 2021, the Biden administration released an executive order that included multiple provisions aimed at prescription drugs. In response to Biden’s executive order, on September 9, 2021, HHS released a Comprehensive Plan for Addressing High Drug Prices that outlines principles for drug price reform. The plan sets out a variety of potential legislative policies that Congress could pursue as well as potential administrative actions by HHS. No legislative or administrative actions have been finalized to implement these principles. In addition, Congress is considering drug pricing as part of the budget reconciliation process. Additionally, the IRA, among other things, (i) directs HHS to negotiate the price of certain high-expenditure, single-source drugs and biologics covered under Medicare, and subjects drug manufacturers to civil monetary penalties and a potential excise tax for offering a price that is not equal to or less than the negotiated “maximum fair price” under the law, and (ii) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation. The IRA permits HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years. Specifically, with respect to price negotiations, Congress authorized Medicare to negotiate lower prices for certain costly single-source drug and biologic products that do not have competing generics or biosimilars and are reimbursed under Medicare Part B and Part D. CMS may negotiate prices for ten high-cost drugs paid for by Medicare Part D starting in 2026, followed by 15 Part D drugs in 2027, 15 Part B or Part D drugs in 2028, and 20 Part B or Part D drugs in 2029 and beyond. This provision applies to drug products that have been approved for at least 9 years and biologics that have been licensed for 13 years, but it does not apply to drugs and biologics that have been approved for a single rare disease or condition. Nonetheless, since CMS may establish a maximum price for these products in price negotiations, we would be fully at risk of government action if our products are the subject of Medicare price negotiations. Moreover, given the risk that could be the case, these provisions of the IRA may also further heighten the risk that we would not be able to achieve the expected return on our drug products or full value of our patents protecting our products if prices are set after such products have been on the market for nine years.

These provisions will take effect progressively starting in fiscal year 2023, although they may be subject to legal challenges. It is currently unclear how the IRA will be effectuated but is likely to have a significant impact on the pharmaceutical industry. If healthcare policies or reforms intended to curb healthcare costs are adopted, or if we experience negative publicity with respect to the pricing of obicetrapib, if approved, or any future product or the pricing of pharmaceutical drugs generally, the prices that we charge for any approved products may be limited, our commercial opportunity may be limited and/or our revenues from sales of our products may be negatively impacted.

Policy uncertainty continues to evolve, as recent executive actions signal the federal government’s increasing focus on lowering prescription drug prices, adding to the uncertainty surrounding future drug pricing and reimbursement frameworks. For example, on May 12, 2025, President Trump signed the executive order titled “Delivering Most-Favored-Nation Prescription Drug Pricing,” which directs the HHS to identify and communicate most-favored-nation price targets for prescription drugs and to propose a rulemaking plan to impose such pricing if “significant progress” is not made. The order also directs the federal government to explore regulatory pathways that would facilitate direct-to-patient sales for manufacturers that meet these price targets. Additionally, it signals potential further action against manufacturers that fail to offer most-favored-nation pricing, including evaluating whether to modify or rescind marketing approvals or allow individual drug importation waivers. In July 2025, President Trump sent letters to pharmaceutical companies demanding further reduced prices more in line with most-favored-nation pricing.

If we obtain regulatory approval and commence commercialization of obicetrapib or any of our future product candidates, these laws could have an adverse effect on the market opportunities for obicetrapib or any of our future product candidates and may result in additional reductions in healthcare funding, which could have an adverse effect on our customers and accordingly, our financial operations. Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products. We cannot be sure whether additional legislative changes will be enacted, or whether additional executive actions will be taken, or whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals of obicetrapib or our future product candidates may be.

Although we cannot predict the full effect on our business of the implementation of existing legislation or the enactment of additional legislation pursuant to healthcare and other legislative reform, we believe that legislation or regulations that would reduce reimbursement for, or restrict coverage of, obicetrapib, if approved, or any of our future products could adversely affect how much or under what circumstances healthcare providers will prescribe or administer our products. This could adversely affect our business by reducing our ability to generate revenues, raise capital, obtain licenses and market our products. In addition, we believe the increasing emphasis on managed care in the United States has and will continue to put pressure on the price and usage of pharmaceutical products, which may adversely impact product sales.

In April 2023, the EU Commission released proposals to amend the current EU pharmaceutical regulatory framework. The potential reforms include shortening the periods of regulatory and/or marketing protections available for innovative products. Depending on the final wording of these reforms (if adopted), a reduction in the periods of regulatory and/or marketing protections available for obicetrapib or any of our future product candidates may adversely affect the commercial viability of such products in the EU. These changes could adversely affect our business by reducing our protection against generic competitors entering the EU market. Depending on the progress of the EU Parliament and Council, changes to EU pharmaceutical legislation are not expected to come into force until 2025 or 2026 and additional transitional periods mean that the changes will most likely not take effect until 2027 or 2028.

Changes in U.S. government policies including increased tariffs could adversely affect our business.

Significant political, trade, or regulatory developments in the jurisdictions in which we may sell our product, if approved, such as those stemming from the change in U.S. federal administration, are difficult to predict and may have a material adverse effect on us. Similarly, changes in U.S. federal policy that affect the geopolitical landscape could give rise to circumstances outside our control that could have negative impacts on our business operations. For example, recent policy actions by the Trump administration, including the imposition of new tariffs on imported materials and goods from certain non-U.S. countries, may have an adverse impact on our business.

In April 2025, the Trump administration imposed a baseline ten percent tariff on imports from all nations importing goods to the United States, with that baseline supplemented in certain cases by additional tariffs that vary by nation, product or industry. Retaliatory tariffs on U.S. goods have been imposed by, among others, China and Canada. On July 28, 2025, the Trump administration announced a trade agreement with the European Union that included a 15% tariff on most imports from the European Union. Furthermore, on September 25, 2025, the Trump administration announced a 100% tariff on certain imported branded pharmaceuticals, subject to certain exceptions. While tariffs with certain countries have been temporarily reduced or paused, the imposition of tariffs generally has historically led to increased trade and political tensions between the United States and other countries in the international community. Political tensions as a result of trade policies could reduce trade volume, investment, technological exchange, and other economic activities between major international economies, resulting in a material adverse effect on global economic conditions and the stability of global financial markets. Any changes in political, trade, regulatory, and economic conditions could have a material adverse effect on our financial condition or results of operations. In addition, increased tariffs on critical raw materials, components, and finished goods could raise our production costs and disrupt our supply chain, which could adversely affect our clinical development activities.

If these or similar policy changes continue or expand, we may face increased costs. Although we cannot predict the full extent of these impacts, any prolonged disruption could adversely affect our business, financial condition, and results of operations.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

None.

Item 3. Defaults Upon Senior Securities.

None.

Item 4. Mine Safety Disclosures.

Not applicable.

Item 5. Other Information.

Rule 10b5-1 Trading Arrangements

Except as set forth below, during the three months ended September 30, 2025, none of our officers or directors adopted, amended or terminated a “Rule 10b5-1 trading arrangement,” as defined in Item 408(c) of Regulation S-K, each of which is intended to satisfy the affirmative defense of Rule 10b5-1(c) under the Exchange Act.

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On September 23, 2025, Louise Kooij, our Chief Accounting Officer, adopted a Rule 10b5-1 trading arrangement for the potential sale of up to 290,000 Ordinary Shares, subject to certain price thresholds and other conditions. The arrangement's expiration date is June 30, 2026.

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On September 26, 2025, Michael Davidson, our Chief Executive Officer, terminated a Rule 10b5-1 trading arrangement that he initially adopted on March 10, 2025, and modified on June 30, 2025, and replaced it with a new Rule 10b5-1 trading arrangement adopted on September 29, 2025 providing for the potential sale of up to 750,000 Ordinary Shares, subject to certain price thresholds and other conditions. The arrangement's expiration date is March 5, 2026.

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On September 29, 2025, Douglas Kling, our Chief Operating Officer, adopted a Rule 10b5-1 trading arrangement for the potential sale of up to 594,573 Ordinary Shares, subject to certain price thresholds and other conditions. The arrangement's expiration date is December 31, 2026.

•

On September 30, 2025, Ian Somaiya, our Chief Financial Officer, adopted a Rule 10b5-1 trading arrangement for the potential sale of up to 200,000 Ordinary Shares, subject to certain price thresholds and other conditions. The arrangement's expiration date is February 20, 2026.

Except as set forth below, no officer or director adopted, amended or terminated a “non-Rule 10b5-1 trading arrangement,” as defined in Item 408(c) of Regulation S-K, during the three months ended September 30, 2025.

•

In September 2025, each holder of outstanding restricted stock units (including each of our officers) entered into a Sell-to-Cover Agreement that constitute a "non-Rule 10b5-1 trading arrangement," which provides for the pre-arranged sale of a portion of any Ordinary Shares deliverable to such holder in connection with the vesting and/or settlement of such holder's restricted stock units in order to satisfy any taxes required to be withheld in connection with such vesting and/or settlement event. The amount of Ordinary Shares to be sold to satisfy such tax withholding obligations under the Sell-to-Cover Agreements is dependent on the then-prevailing market price of the Ordinary Shares at the time of the vesting of the restricted stock units. Each Sell-to-Cover Agreement remains in effect until the date on which the holder’s tax withholding obligations arising from the last vesting or settlement event of the applicable restricted stock units have been satisfied, unless earlier terminated in certain limited circumstances.

Director Resignation

On November 2, 2025, Nicholas Downing notified our Board of Directors of his decision to resign from the Company’s Board of Directors and its committees, effective as of November 5, 2025. Mr. Downing’s resignation was not the result of any disagreement with us on any matter relating to our operations, policies, or practices. We and our Board of Directors wish to express our appreciation for Mr. Downing’s service and contributions during his tenure on the Board.

Item 6. Exhibits.

      
     Incorporated by Reference to Filings Indicated

     Exhibit No.

     Description of Document

     Form

     File No.

     Exhibit 

     Filing Date

     Filed Herewith

         3.1

     English translation of the Deed of Conversion and Articles of Association of NewAmsterdam Pharma Company N.V. 

     20-F

     001-41562

     1.1

     11/28/22

        10.1

     Supply Agreement, dated August 12, 2025, between A. Menarini International Licensing S.A. and NewAmsterdam Pharma B.V. †

     X

        10.2

     NewAmsterdam Pharma Company N.V. Inducement Plan

     X

        10.3

     Employment Agreement, dated July 11, 2025, between NewAmsterdam Pharma B.V. and Dr. John Kastelein.

     10-Q

     001-41562

     10.2

     08/06/2025

        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.

     X

        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.

     X

        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.

     X

        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.

     X

     101.INS

     Inline XBRL Instance Document

     X

     101.SCH

     Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents

     X

     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 

     X

     †

     Portions of this exhibit (indicated by asterisks) have been omitted in compliance with Item 601 of Regulation S-K

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.


	NewAmsterdam Pharma Company N.V.

Date: November 5, 2025	By:	/s/ Michael Davidson
		Michael Davidson, M.D.
		Chief Executive Officer and Director
		(Principal Executive Officer)

Date: November 5, 2025	By:	/s/ Ian Somaiya
		Ian Somaiya
		Chief Financial Officer
		(Principal Financial Officer)

EX-10.1 2 nams-ex10_1.htm EX-10.1 EX-10.1

Dated 12th August 2025

SUPPLY AGREEMENT

by and between

NEWAMSTERDAM PHARMA B.V.

and

A. MENARINI INTERNATIONAL LICENSING S.A.

TABLE OF CONTENTS

1. DEFINITIONS AND INTERPRETATION 1

2. SUPPLY OF PRODUCT 6

3. SUPPLY CHAIN GOVERNANCE 9

4. FORECASTS & ORDERING 9

5. DELIVERY 11

6. PRODUCT ACCEPTANCE, NON-CONFORMING PRODUCT AND SHORTFALLS 13

7. PRICE 15

8. INVOICING AND PAYMENT 15

9. REPRESENTATIONS AND WARRANTIES 17

10. MANUFACTURING TRANSFER 17

11. REGULATORY MATTERS 18

12. COMPLIANCE 19

13. CONFIDENTIALITY 19

14. INDEMNITIES 20

15. LIABILITY 20

16. INSURANCE 20

17. FORCE MAJEURE 21

18. TERM AND TERMINATION 21

19. EFFECTS OF TERMINATION 22

20. INDEPENDENT CONTRACTORS 23

21. NOTICES 23

22. MISCELLANEOUS 25

SCHEDULES

Schedule 1 Facilities

Schedule 2 Drug Product Specifications

Schedule 2.2 CDMOs

Schedule 4.1.1 Long Term Forecast

Schedule 4.1.2 Initial Product Forecast

Schedule 4.2 Initial Purchase Order Template

THIS SUPPLY AGREEMENT (this “Supply Agreement”) is dated 12th August 2025 (the “Effective Date”)

BETWEEN:

Schedule 7.1 COGS and Price NEWAMSTERDAM PHARMA B.V., a company with limited liability incorporated under the laws of the Netherlands, having its registered office at Gooimeer 2-35, 1411 DC Naarden, the Netherlands and registered with the Dutch trade register under number 55971946 (“Supplier”); and

A. MENARINI INTERNATIONAL LICENSING S.A., a company incorporated under the laws of Luxembourg, having its registered offices in 12-C Impasse Drosbach, L-1882 Luxembourg and registered at Luxembourgish Chamber of Commerce under the number RCS B243845 (“Purchaser”)

(each a “Party”, collectively the “Parties”).

BACKGROUND:

Supplier and Purchaser entered into that certain License Agreement, dated June 23, 2022 (the “License Agreement”), pursuant to which Supplier licensed to Purchaser certain intellectual property rights to (i) obtain and maintain Regulatory Approvals (ii) Commercialize and (iii) undertake Local Development, in each case, with respect to Licensed Products in certain specified European countries.

Pursuant to Section 2.4 of the License Agreement, Supplier and Purchaser have agreed to enter into an agreement pursuant to which Supplier will supply to Purchaser, and Purchaser will purchase from Supplier, Drug Products in accordance with the terms and conditions of the License Agreement.

For the avoidance of doubt, this Supply Agreement is the Supply Agreement defined and referred to in the License Agreement.

In accordance with the terms of the License Agreement, Supplier and Purchaser have also agreed to enter into the Quality Agreement, dated at or around the date hereof, with respect to the Drug Products under this Supply Agreement.

THE PARTIES AGREE THAT:

DEFINITIONS AND INTERPRETATION

1.1

Unless otherwise defined in this Supply Agreement, capitalized terms used in this Supply Agreement have the meanings ascribed to them in the License Agreement, as applicable.

1.2

In this Supply Agreement, the following words and expressions shall have the following meanings:

[***];

“API” means, on a Drug Product-by-Drug Product basis, the active pharmaceutical ingredient or drug substance used in the manufacture of such Drug Product;

“API Registration Date” means the date on which Supplier’s registration as a wholesale distributor of active substances is granted, or deemed to have been granted, by Farmatec in accordance with Sections 38 and 38a of the Dutch Medicines Act;

“Availability Date” has the meaning given in Clause 5.2.2;

“Batch Certificate” means the signed statement by a representative of Supplier with appropriate authority to formalize the batch certification to accompany each batch of Drug Product Delivered to Purchaser, as further defined in the Quality Agreement, which certifies that such Drug Product has been Manufactured and tested in compliance with cGMP and the applicable Specification;

“Binding Period” has the meaning given in Clause 4.1.3;

“Breaching Party” has the meaning given in Clause 18.2;

“CapEx” means any capital expenditures incurred or committed to by Supplier or its Affiliates in respect of the purchase, financing or other acquisition of any fixed or capital asset (excluding normal replacements and maintenance in the ordinary course of business) related to the Manufacture of Product by or on behalf of Supplier (including by any CDMO) and the supply of Product under this Supply Agreement;

“CDMO” means a Third Party contract development and manufacturing organization that has contracted with Supplier to Manufacture, or engage in Manufacturing activities with respect to, the Product. Schedule 2.2 sets forth the list of CDMOs as of the Effective Date;

“Certificate of Analysis” means the certificate of analysis to accompany each Product Delivered to Purchaser, which certifies that such Product has been tested in compliance with its Specification;

“cGMP” means all then-current applicable requirements and standards for the Manufacture of pharmaceutical products for human use and their components, including, as applicable:

(i) the current Good Manufacturing Practices relevant for the United States, including section 501(a)(2)(B) of the FFDCA (21 U.S.C. § 351(a)(2)(B)), and U.S. Code of Federal Regulations Title 21 parts 210-211, 600 and 610;

(ii) the current Good Manufacturing Practices relevant for the European Union, as defined by the European Commission Directive 2017/1572 as regards the principles and guidelines of good manufacturing practice for medicinal products for human use supplementing Directive 2001/83/CE, as amended and the EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines, and any other guideline, law, or regulation applicable to the manufacture of medicinal products for human use. For clarity, this clause (ii) shall be applicable to any manufacturer in countries outside of the European Union with respect to the manufacturing of medicinal products intended to be placed on the market in the European Union;

(iii) all Regulatory Approvals and applicable local laws at the site(s) of manufacture or testing, including GUI-001 Good Manufacturing Practices Guide for Drug Products (Canada) and Schedule M of The Drug Rules, Good Manufacturing Practices and Requirements of Premises, Plant, and Equipment for Pharmaceuticals Products (India); and

(iv) with respect to active pharmaceutical ingredients, in addition (as applicable) the International Conference on Harmonization (ICH) current good manufacturing practices, as specified in ICH Q7, and all successor regulations and guidance documents thereto;

“Change Notice” has the meaning given in Clause 2.3.2; “Change Response” has the meaning given in Clause 2.3.2;

“Commercial API” means obicetrapib from Supplier’s existing inventory of API intended to be used in the Manufacture of Drug Product for commercial purposes;

“Commercially Reasonable Efforts” means, with respect to the Manufacture or supply of Products provided hereunder, the [***];

“Cost of Goods Sold” or “COGS” means, with respect to a Product or Technical API, [***];

“Default Notice” has the meaning given in Clause 18.2;

“Defect” means with respect to a Product, that such Product has not been Manufactured or Delivered in accordance with (a) the applicable Specifications for such Product, (b) cGMP or the requirements under the Quality Agreement or (c) Applicable Law in the countries in which they are Manufactured;

“Delivery” has the meaning given in Clause 5.2.3, and when used as a verb, “Deliver” and “Delivered” shall have a corresponding meaning;

“Delivery Location” means the location for Delivery of a Product as notified to Purchaser by Supplier, which, unless otherwise agreed by the Parties, shall, in each case, be an appropriate location for the collection of the Product at the applicable Facility of the CDMO at which the applicable Product to be Delivered was Manufactured;

“Dispute” has the meaning given in Clause 22.7;

“Drug Product” means the Obicetrapib Product or the Ezetimibe Fixed Dose Combination Product, in each case in bulk tablet form;

“Drug Product Forecast” has the meaning given in Clause 4.1.2;

“Effective Date” has the meaning given in the introductory paragraph hereto;

[***];

“Facility” means the manufacturing facility or facilities of a CDMO at which the Manufacturing of the Product is performed. The list of Facilities as of the Effective Date is as set out in Schedule 1 and may be updated as agreed by the Parties following any changes with respect thereto in the Quality Agreement;

“FDA” means the United States Food and Drug Administration and any successor agency or authority having substantially the same function;

[***];

“Force Majeure” means [***];

“Full Batch” means, with respect to a Drug Product, the registered batch size at each Facility as described in Schedule 1;

“Governmental Entity” means any supranational, international, national, federal, state, provincial, local or foreign court of competent jurisdiction, governmental agency, authority, instrumentality or regulatory body;

[***];

“Indirect Tax” means any sales, use, goods and services, turnover, value-added, or similar tax (together with any penalties in respect thereof and interest thereon);

“Initial Forecast” has the meaning given in Clause 4.1.2;

“Initial Inspection” has the meaning given in Clause 6.3; “Labelling” means all labels, package inserts, carton imprints and all other markings on packaging for the Products that are defined as labels or labelling under any relevant Regulatory Approval (excluding, for the avoidance of doubt, any transportation packaging);

“License Agreement” has the meaning given in the recitals hereto;

“Major Manufacturing Change” has the meaning given in Clause 2.3.2(b);

“Manufacture” means all activities related to the production, manufacture, processing and filling of any Product, or any intermediate thereof, including process development, process qualification and validation, scale-up, commercial manufacture, analytic development, product characterization, stability testing, quality assurance, and quality control, provided that for the purposes of this Supply Agreement, “Manufacture” shall not include activities directed to finishing, packaging, labelling, quality assurance testing and release (including, as applicable, QP release) of the Product for Commercialization or exploitation in the Territory;

“Manufacturing Change” means changes to the Facilities, Specifications or changes in the Manufacturing process (including test methods), or materials (or sources of materials) used by Supplier, its Affiliates or its CDMOs to Manufacture any Drug Product;

“Manufacturing Transfer” has the meaning given in Clause 10.1;

[***];

“Marketing Authorization” means, with respect to a given Drug Product, the marketing authorization granted by the applicable Regulatory Authority in the Territory that allows the Drug Product to be placed on the market in the Territory, including any variations thereto. For the avoidance of doubt the Marketing Authorization shall include any Drug Product related information approved by the applicable Regulatory Authority in the Territory, for the use of the Drug Product in the Territory, including approved manufacturing sites, manufacturing process, and specifications;

[***];

“Non-Binding Period” has the meaning given in Clause 4.1.4;

“Non-Breaching Party” has the meaning given in Clause 18.2;

“Non-Conforming Product” means any Product, which, at the time of Delivery, contains a Defect or, with respect to any Drug Product, fails to meet the Residual Shelf Life Requirement set out in Clause 6.2;

“Party” has the meaning given in the introductory paragraph hereto;

“Payee” has the meaning given in Clause 8.5;

“Payment Breach Notice” has the meaning given in Clause 8.3.2;

“Personnel” means the employees, officers, agents and contractors of a Party or (where the context requires) of a Party’s Affiliates, excluding, in each case, any CDMOs;

“PQR” means product quality review under cGMP;

“Price” means the price as applicable under Clause 7.1;

“Price Change” means any Annual Price Change or Additional Price Change;

“Product” means Drug Product or the Commercial API, as applicable;

“Purchase Order” has the meaning given in Clause 4.2;

“Purchaser” has the meaning given in the introductory paragraph hereto; “Quality Agreement” has the meaning given in Clause 11.1;

[***];

“Required Manufacturing Change” has the meaning given in Clause 2.3.3;

“Residual Shelf Life Requirement” has the meaning given in Clause 6.2;

“Shortfall” means the quantity of a Product actually Delivered to Purchaser that is less than [***] of the quantity set out for such Product in the applicable Purchase Order;

“SKU” means, with respect to a Drug Product, a stock keeping unit for that Drug Product (it being acknowledged that there may be more than one (1) SKU for a Drug Product from time to time);

“Specification” means, (a) with respect to a Drug Product, the written specifications for such Drug Product, the references to which are as set forth on Schedule 2 and (b) with respect to Commercial API, the applicable portion of the Drug Product Specifications, in each case ((a) and (b)), as may be amended or replaced from time to time in accordance with this Supply Agreement and the Quality Agreement;

“Supplier” has the meaning given in the introductory paragraph hereto;

“Supplier Territory Manufacturing Change” has the meaning given in Clause 2.3.2(a);

“Supply Agreement” has the meaning given in the introductory paragraph hereto;

“Supply Term” has the meaning given in Clause 18.1;

“Tax” means and includes all forms of taxation, levy, impost or duty and any similar charge, contribution, deduction or withholding and all penalties, charges, surcharges, fines, costs and interest included in, or relating to, any of the foregoing or to any obligation in respect of any of the foregoing;

“Technical API” means obicetrapib from Supplier’s existing inventory of API intended to be used solely for non-commercial (a) research or (b) equipment testing purposes (and for no other use or purpose) in accordance with this Supply Agreement;

“Territory” means the Territory as it is defined in the License Agreement, except for any country that becomes a Terminated Territory pursuant to the License Agreement;

“Third Party” means any Person other than Supplier, Purchaser and their respective Affiliates;

“Third Party Claim” has the meaning given in Clause 14.1;

“Unit” means a single tablet of Drug Product; and

“Withholding Agent” has the meaning given in Clause 8.5.

1.3

In this Supply Agreement, except to the extent expressly provided otherwise herein:

1.3.1

when a reference is made in this Supply Agreement to a Clause or Schedule, such reference is to a Clause of or a Schedule to this Supply Agreement respectively, and all Schedules to this Supply Agreement form a part hereof for all purposes;

1.3.2

the contents page and headings are included for convenience only and shall not affect the interpretation or construction of this Supply Agreement;

1.3.3

where any Party gives in this Supply Agreement any indemnity in favor of the other Party the obligation of the indemnifying Party shall be to make the relevant payment forthwith in full on demand and without any set-off, counterclaim or other deduction (save to the extent required by Applicable Law);

1.3.4

any reference to a Person is also to such Person’s successors and permitted assigns;

1.3.5

any use of the masculine, feminine or neuter gender respectively includes the other genders and any reference to the singular includes the plural (and vice versa);

1.3.6

the words including, includes or include, whenever used in this Supply Agreement, are deemed to be followed by the words “without limitation”; in particular means “in particular but without limitation”, “such as” means “such as without limitation” and other general words shall not be given a restrictive interpretation by reason of their being preceded or followed by words indicating a particular class of acts, matters or things;

1.3.7

any reference to a statute or statutory provision includes any successor legislation thereto, regulations promulgated thereunder, any consolidation or re-enactment, modification or replacement thereof, any statute or statutory provision of which it is a consolidation, re-enactment, modification or replacement and any subordinate legislation in force under any of the same from time to time except in each case to the extent that any consolidation, re-enactment, modification or replacement enacted after the date of this Supply Agreement would extend or increase the obligations, in any manner (and whether financial obligations or otherwise), of either Party hereunder;

1.3.8

the word “or” is used in the inclusive sense, as in “and/or”;

1.3.9

any reference to writing shall include any modes of reproducing words in a legible and non-transitory form (excluding short-message-service (SMS), e-mail and other electronic communications, save that e-mail may be used as a means of delivering written notice for the purposes of Clause 21 (for example, where a PDF copy of a written notice is sent as an attachment to an e-mail)) and as provided in Clause 21.2;

1.3.10

subject to Clause 2.2, any reference to an obligation of Supplier shall be deemed to be an obligation owed to Purchaser, and any reference to an obligation of Purchaser shall be deemed to be an obligation owed to Supplier;

1.3.11

any obligation on a Party not to do something includes an obligation not to allow that thing to be done;

1.3.12

reference to any date or time is a reference to such date or time in Amsterdam, Netherlands; and

1.3.13

whenever this Supply Agreement refers to a number of days, unless otherwise specified, such number refers to calendar days.

1.4

Unless otherwise expressly stated or the context otherwise requires, in case of a conflict between:

1.4.1

the provisions of any Schedule and the provisions of the main body of this Supply Agreement, the provisions of the main body of this Supply Agreement shall prevail;

1.4.2

the provisions of the License Agreement and the provisions of this Supply Agreement, the provisions of the License Agreement shall prevail; and

1.4.3

the provisions of the Quality Agreement and the provisions of this Supply Agreement, the provisions of this Supply Agreement shall prevail, except that with respect to matters solely related to quality, the Quality Agreement shall prevail.

SUPPLY OF PRODUCT

2.1

Drug Product Requirements . Subject to the provisions of this Supply Agreement, during the Supply Term, Purchaser shall, until the Manufacturing Transfer is completed pursuant to and in accordance with Clause 10, exclusively purchase, and Supplier shall supply (or have supplied) to Purchaser, all of Purchaser’s requirements of the Drug Products for Commercialization and Local Development in the Field in the Territory.

Purchaser’s rights with respect to its use and exploitation of the Drug Products, including the limitations and restrictions in respect thereof, shall be as set forth in the License Agreement.

2.2

CDMOs . Purchaser acknowledges and agrees that, as of the Effective Date, Supplier has contracted with those CDMOs set forth on Schedule 2.2. Supplier shall not contract with other Third Parties for the Manufacture of the Products without Purchaser’s prior approval. Subject to Clause 6.9.2, Supplier shall be responsible to Purchaser for any actions, omissions and performance of any CDMO contracted by Supplier for the Manufacture of the Products.

2.3

Change Control .

2.3.1

Supplier may not, and shall procure that its CDMOs shall not, implement any Manufacturing Change that requires notification to or the approval of a Regulatory Authority in the Territory, or requires approval of Purchaser under the terms of the Quality Agreement, until such Manufacturing Change has been notified as required under Applicable Law, has the relevant approval from the applicable Regulatory Authority in the Territory or has been approved by Purchaser under the terms of the Quality Agreement (as applicable).

2.3.2

Subject to Clause 2.3.1 and Clause 2.3.4, Supplier has the right to propose Manufacturing Changes with respect to any Drug Product (including, for clarity, changes to, or the addition of, Facilities) as further set forth in this Clause 2.3 and in accordance with any applicable requirements set forth in the Quality Agreement. Unless otherwise agreed by the Parties, any Manufacturing Changes proposed by Supplier shall have a minimum target term for implementation of [***] from the date of the relevant Change Notice; unless a shorter time period (a) is required by a Regulatory Authority or (b) is necessary, in Supplier’s reasonable opinion, due to safety or other regulatory concerns or as a result of recalls. If Supplier wishes to make a Manufacturing Change with respect to any Drug Product, it shall provide Purchaser with prompt written notice of such determination and description of such proposed Manufacturing Change, including expected timelines for implementation (a “Change Notice”). Upon receipt of a Change Notice, Purchaser shall promptly assess such proposed Manufacturing Change and, upon assessment of such change, and in no event no later than next meeting of the Parties or the JCC in accordance with Clause 3.1 (provided that such meeting takes place not earlier than [***] Business Days of receipt of such Change Notice), Purchaser shall provide written notice to Supplier confirming the regulatory impact, including the impact on Purchaser’s ability to obtain or maintain the applicable Marketing Authorization, if any, for the Territory with any estimated filing, notice and approval dates, as applicable and as available (“Change Response”). If Supplier reasonably believes that implementation of a proposed Manufacturing Change may be required by a Regulatory Authority on a shorter time period than the time periods set out in this Clause 2.3.2, then Supplier shall include such timelines in the applicable Change Notice. If Purchaser believes such proposed Manufacturing Change (x) impacts Purchaser’s ability to obtain or maintain the applicable Marketing Authorization, (y) requires notice to or approval of a Regulatory Authority in the Territory or (z) requires approval of Purchaser under the terms of the Quality Agreement, then Purchaser shall include in the Change Response a request to meet with Supplier to determine if such proposed Manufacturing Change meets subclauses (x) through (z) above. Within [***] Business Days of Supplier’s receipt of Purchaser’s request to meet, or such shorter time period as may be required by such Regulatory Authority, the Parties shall meet and determine if such Manufacturing Change would (i) impact Purchaser’s ability to obtain or maintain the applicable Marketing Authorization, (ii) require notice to or approval of a Regulatory Authority in the Territory or (iii) require approval of Purchaser under the terms of the Quality Agreement. Any determination with respect to notice to or approval of a Regulatory Authority in the Territory shall be subject to Section 2.2.2 of the License Agreement.

Purchaser shall provide a Change Response to Supplier within [***] Business Days of receipt of such Change Notice.

(a)

If a proposed Manufacturing Change other than a Required Manufacturing Change for which Supplier has provided a Change Notice (i) does not impact Purchaser’s ability to obtain or maintain the Drug Product’s Marketing Authorization and (ii) does not require notice to or approval of any Regulatory Authority in the Territory and (iii) does not require approval of Purchaser under the terms of the Quality Agreement, as determined in accordance with Clause 2.3.2 (each, a “Supplier Territory Manufacturing Change”), then Supplier may implement or procure the implementation of such Supplier Territory Manufacturing Change without further approval from Purchaser; provided that Supplier keeps Purchaser reasonably informed regarding the implementation of such Supplier Territory Manufacturing Change. Supplier shall have the final say with respect to any Supplier Manufacturing Change. The costs of any Supplier Manufacturing Change will be borne by [***].

(b)

If a proposed Manufacturing Change other than a Required Manufacturing Change for which Supplier has provided a Change Notice (i) impacts Purchaser’s ability to obtain or maintain the Drug Product’s Marketing Authorization, (ii) requires notification to or the approval of a Regulatory Authority in the Territory, (iii) or requires approval of Purchaser under the terms of the Quality Agreement, as determined in accordance with Clause 2.3.2 (each, a “Major Manufacturing Change”), then Purchaser shall, as applicable (x) file any required notifications with the applicable Regulatory Authorities or (y) upon approval of such Major Manufacturing Change in accordance with this Clause 2.3.2(b), [***] obtain any required approvals from the applicable Regulatory Authorities, in each case ((x) and (y)), as soon as possible. Purchaser shall, in accordance with and subject to Section 2.2.3 of the License Agreement, be responsible for communications with the Regulatory Authorities in the Territory with respect to any such notifications or approvals and for filing any necessary documents or consents required to obtain any such approval or with respect to any required notification (as applicable). Supplier shall, upon the request of Purchaser, provide reasonable cooperation with any such filing to the extent reasonably required. Purchaser shall promptly, and in no event later than [***] Business Days thereafter, notify Supplier upon receipt of any required approval from the applicable Regulatory Authority or the filing of any required notification in order to enable Supplier to implement or procure the implementation of the Major Manufacturing Change. If Purchaser does not obtain approval of the Major Manufacturing Change from the applicable Regulatory Authority in a country in the Territory, or if Purchaser becomes aware of a potential failure to timely receive such approval, Purchaser shall promptly, and in no event later than [***] Business Days thereafter, notify Supplier thereof. In such event, the Parties shall discuss in good faith potential options with respect to such Major Manufacturing Change and agree on any such Major Manufacturing Change before it is implemented. Any Major Manufacturing Change that impacts Purchaser’s ability to obtain or maintain the Drug Product’s Marketing Authorization or requires the approval of a Regulatory Authority in the Territory or approval of Purchaser under the terms of the Quality Agreement shall require the mutual agreement of the Parties and the approval of the Regulatory Authority (as applicable) prior to implementation. In the event the Parties are unable to agree, then such decision regarding the Major Manufacturing Change would be deadlocked; provided that Purchaser shall have final say with respect to any such Major Manufacturing Change to the extent relating solely to the Territory. The costs of any Major Manufacturing Change will be allocated in accordance with Clause 2.3.4.

2.3.3

If a Regulatory Authority requests or requires any Manufacturing Change, or Supplier determines in good faith a Manufacturing Change is required to comply with Applicable Law, with respect to the Manufacture of a Drug Product or its Specifications (each, a “Required Manufacturing Change”), then the Parties shall each, acting reasonably and in good faith, use reasonable endeavors to agree an action plan in relation to the implementation of such Required Manufacturing Change within [***] Business Days, or such shorter time period as may be required by such Regulatory Authority, of receipt of notice from the Regulatory Authority of the Required Manufacturing Change. If either Party receives notice, or is otherwise informed of, any Required Manufacturing Change, such Party will deliver notice thereof to the other Party as promptly as practicable, and in no event later than [***] Business Days thereafter. Supplier shall have the final say with respect to any Required Manufacturing Changes. The costs of any Required Manufacturing Change will be allocated in accordance with Clause 2.3.4.

2.3.4

[***] shall bear any implementation costs associated with a Major Manufacturing Change or a Required Manufacturing Change, unless [***].

SUPPLY CHAIN GOVERNANCE

3.1

Supply Chain Governance . The Parties shall meet to discuss supply issues relating to the Drug Product, including Manufacturing capacity, forecasting, Delivery dates, Manufacturing Changes, quality issues and deviation management and business continuity planning on a quarterly basis or more frequently as reasonably requested by either Party during the Supply Term. Until the disbandment of the JCC in accordance with the License Agreement, the Parties shall report any material supply issues to the JCC. For clarity, such meetings shall be with respect to supply of Drug Product only, and not supply of API or the Manufacturing Transfer.

FORECASTS & ORDERING

4.1

Forecasts. Supply of Drug Product under this Supply Agreement shall be pursuant to forecasts and orders submitted by Purchaser, as further described in this Clause 4.

4.1.1

Long Term Forecast. Set forth on Schedule 4.1.1 is an initial long-term forecast of Purchaser’s anticipated volume requirements for the Drug Product for [***]. During the Supply Term, Purchaser shall provide to Supplier [***], an updated non-binding written forecast of Purchaser’s good-faith estimate of its anticipated volume requirements on an SKU basis in Units, which forecast quantities shall be equivalent to whole number multiples of Full Batches, for each Drug Product [***], or such shorter period remaining under the Supply Term.

4.1.2

Rolling Monthly Forecast. Set forth on Schedule 4.1.2 is an initial Drug Product Forecast (“Initial Forecast”). After the Effective Date, [***], Purchaser shall submit to Supplier a rolling forecast (in a format agreed by the Parties) that sets forth Purchaser’s good faith estimate of its anticipated monthly volume requirements for each Drug Product on an SKU basis in Units, which forecast quantities shall be equivalent to whole number multiples of Full Batches, for at least the [***] (“Drug Product Forecast”), or such shorter period remaining under the Supply Term. The Drug Product Forecast shall identify Drug Products on an SKU basis.

4.1.3

Binding Period. The forecast quantities for the [***] set out in the then-current Drug Product Forecast (the “Binding Period”) shall be binding on Supplier and Purchaser, and the forecast quantities included for each Drug Product in any month in the Binding Period may not be varied in any subsequent Drug Product Forecast unless Supplier otherwise agrees in writing.

4.1.4

Non-Binding Period. Subject to Clause 4.1.5, the forecast quantities for the [***] period following the Binding Period in a Drug Product Forecast (the “Non-Binding Period”) shall be non-binding, and Purchaser may amend the forecast quantities set forth in any month in the Non-Binding Period until such month becomes a month in the Binding Period.

4.1.5

Missing Forecasts. Without prejudice to Purchaser rights and Supplier obligations under this Supply Agreement, if Purchaser fails to provide a Drug Product Forecast to Supplier, then the next [***] of the last-submitted Drug Product Forecast shall then become the [***] of the current Drug Product Forecast. If Purchaser fails to provide [***] Drug Product Forecasts, then such failure shall constitute a material breach of this Supply Agreement, subject to a reasonable opportunity to cure as set forth in Clause 18.2.

4.2

Purchase Orders.

4.2.1

On or before the [***] Business Day of each month of the Supply Term, Purchaser shall deliver to Supplier a written purchase order (“Purchase Order”) for such month corresponding to the forecast quantities entering the Binding Period for such Drug Products set forth for such month of the then-applicable Drug Product Forecast.

4.2.2

Supplier will notify Purchaser [***] days after the API Registration Date, and within [***] days after receipt of such notice from Supplier, Purchaser shall deliver to Supplier a Purchase Order for [***] of Commercial API. For the avoidance of doubt, Supplier shall have no obligation to supply Commercial API until after the API Registration Date and after submission of a Purchase Order with respect thereto.

4.2.3

The initial template for Purchase Orders is set forth on Schedule 4.2. Each Purchase Order shall specify:

(a)

the Products ordered,

(b)

the quantities of each Product ordered,

(c)

the Price for the Products ordered, and

(d)

the requested delivery date.

4.3

Minimum Order Quantities . Unless otherwise agreed by the Parties with respect to a particular Purchase Order, all quantities of Drug Product, on an SKU basis, ordered by Purchaser in a particular Purchase Order shall be for the Unit equivalent of one (1) Full Batch or a whole number multiple of the registered batch size at each manufacturing site as described in Schedule 1. If the volume specified in a Purchase Order is not equivalent to a whole number multiple of a Full Batch, such volume shall be rounded up by the minimum amount necessary for such volume to equal a whole number multiple of a Full Batch, and Purchaser shall be deemed to agree to this change. For each Calendar Year in the Supply Term, no later than the preceding [***] of such Calendar Year, Supplier shall provide to Purchaser an annual plan setting out its reasonable estimate of the monthly production split of Drug Product it anticipates to be Manufactured at each Facility for such Calendar Year.

4.4

CapEx. [***] shall be responsible for the cost of [***] of the CapEx, provided that the total balance of the CapEx shall be [***].

4.5

Order Confirmation. Supplier shall promptly respond to each Purchase Order received from Purchaser. Unless otherwise agreed by the Parties, Supplier shall be obliged to acknowledge and accept Purchase Orders that are delivered in accordance with Clause 4.2 and comply with the requirements of Clause 4.3. Supplier’s response shall include confirmation of the delivery date and the Delivery Location for such Purchase Order. In the event that Supplier fails to respond to any Purchase Order that is delivered in accordance with Clause 4.2 and complies with the requirements of Clause 4.3 within [***] Business Days of receipt of such Purchase Order, Supplier shall be deemed to have acknowledged and accepted that Purchase Order. For clarity, Supplier shall not be obliged to accept any Purchase Order that is in excess of the forecast quantities for such Drug Products set forth for such month in the Binding Period of the then-applicable Drug Product Forecast.

Supplier will try to accommodate any increases in the demand that occur within the Binding Period.

4.6

Amendments to Purchase Order. To the extent that Supplier proposes an amendment to a Purchase Order, including to account for differences in the applicable Full Batch size at the applicable Facility that will manufacture such Drug Product, Purchaser shall respond to any proposed amendments as soon as reasonably possible, and in any event within [***] Business Days, confirming whether it accepts or rejects such proposed amendments. If Purchaser:

4.6.1

accepts such amendments or fails to respond within [***] Business Days of Supplier’s proposed amendments, then the Purchase Order will be amended accordingly and such Purchase Order with the relevant amendment(s) shall be binding on both Parties; or

4.6.2

rejects such proposed amendments, then the Parties will discuss the proposed amendments in good faith as promptly as practicable, but not more than [***] Business Days following such rejection.

If the Parties cannot agree on an amendment to a Purchase Order pursuant to this Clause 4.6, the Purchase Order initially submitted without the proposed amendments shall be binding on the Parties to the extent it is delivered in accordance with Clause 4.2 and complies with the requirements of Clause 4.3, provided that (a) notwithstanding the foregoing, Supplier may amend the quantities of Drug Product ordered to account for differences in the applicable Full Batch size at the applicable Facility that will manufacture such Drug Product (for clarity, unless otherwise agreed by the Parties with respect to a Purchase Order, Supplier shall not amend the number of Full Batches ordered but only make such amendments to account for differences in the Full Batch size at the applicable Facility); and (b) Supplier may refer the matter for resolution in accordance with Clause 22.7.

4.7

Cancellation. Purchase Orders shall be placed on a [***].

4.8

Supplier’s Fulfillment of Purchase Orders. Subject to Clause 5.2.1, Clause 5.2.6 and Clause 5.4, Supplier shall [***].

DELIVERY

5.1

Delivery. Subject to Clause 4.8, Supplier shall deliver to Purchaser the Products ordered pursuant to a given Purchase Order EXW (as defined in INCOTERMS 2020 edition, published by the International Chamber of Commerce, ICC Publication 560) at the Delivery Location as specified in Supplier’s Purchase Order confirmation provided pursuant to Clause 4.5, unless such location is otherwise amended in accordance with Clause 4.6. Risk of loss or damage to Products and title to the Product shall pass to Purchaser upon Delivery of the Products at the Delivery Location.

5.2

Delivery Date .

5.2.1

Supplier shall, by placing timely orders with Supplier’s CDMOs (in respect of Drug Product only), make Products available for collection within [***] days of the delivery date for such Products as specified in Supplier’s Purchase Order confirmation provided pursuant to Clause 4.5, unless such date is otherwise amended in accordance with Clause 4.6. Supplier shall provide notice to Purchaser if Supplier’s date of delivery is early or delayed.

5.2.2

Supplier shall notify Purchaser when Product will be available for collection by Purchaser (or its carrier or designee) at the Delivery Location [***] days prior to such Product being available for collection (such date of the Product being available for collection, the “Availability Date”). Purchaser shall respond to Supplier within [***] days after receipt of Supplier’s notification of the Availability Date confirming when Purchaser (or its carrier or designee) will collect the Product from the Delivery Location, and Purchaser shall collect the Product from the Delivery Location within [***] days after the Availability Date.

5.2.3

Delivery of Product shall occur on the earlier of (a) collection of the Product by Purchaser (or its carrier or designee), and (b) [***] day after the Availability Date (“Delivery”).

5.2.4

If for any reason Purchaser fails to arrange for its carrier to arrive at the Delivery Location for collection on the Availability Date, Supplier will request that the applicable CDMO continue to store or procure the storage of the Product at the Delivery Location for up to [***] days after the Availability Date until Purchaser collects such Product. Supplier shall notify Purchaser of any costs incurred with respect to storage of the Product at the Delivery Location, which shall be borne by Purchaser. Supplier shall issue an invoice to Purchaser for such reasonably and actually incurred and documented additional costs within [***] Business Days after such incurrence, and Purchaser shall pay such amount to Supplier within [***] days after Purchaser’s receipt of such invoice.

5.2.5

If for any reason Suppliers fails to deliver the Product at the Delivery Location on the Availability Date and does not notify Purchaser if Supplier’s date of delivery is early or delayed with more than [***] notice before the Availability Date, and, as a direct result thereof, Purchaser incurs additional logistic costs to arrange for its carrier to reschedule or cancel its collection, Purchaser shall issue an invoice to Supplier for such reasonably and actually incurred and documented additional logistic costs within [***] Business Days after such incurrence, and Supplier shall pay such amount to Purchaser within [***] days after Supplier’s receipt of such invoice. Purchaser shall use commercially reasonable efforts to mitigate any such additional logistic costs in arranging for its carrier to reschedule or cancel its collection.

5.2.6

Supplier shall not be liable for any delay in Delivery of the Product that is caused by Force Majeure, by Purchaser’s negligence or breach of this Supply Agreement or by Purchaser’s failure to provide Supplier with any relevant instruction related to the supply of the Product.

5.3

Documentation. On Delivery, Supplier shall provide to Purchaser a Batch Certificate and a Certificate of Analysis for the Drug Product Delivered or a Certificate of Analysis for the Commercial API Delivered, as applicable, and any other documentation required to be provided on Delivery as expressly set forth in the Quality Agreement or as mutually agreed by the Parties from time to time. All such documents shall be supplied in the English language where available and as per the Quality Agreement.

5.4

Quantity. In respect of all Purchase Orders, Supplier shall be entitled to Deliver quantities of Products that are plus or minus [***] of the quantity set out in the Purchase Order, and Purchaser shall not be entitled to reject any Delivery on this basis.

5.5

Testing, Packaging and Labelling. Supplier shall, or shall cause its CDMOs to, package the Products ready for collection in accordance with its customary practices and any requirements set forth in the applicable Specifications with respect to the packaging required for Delivery. Prior to Delivery, Supplier shall, subject to Clause 5.7, perform, or procure the performance of, required stability and manufacturing release testing for the Product pursuant to the applicable Specifications, cGMP and the Quality Agreement, as applicable. Supplier shall label the Products in compliance with cGMP and as necessary to identify the content of the respective Product. Purchaser is otherwise responsible for all Labelling and packaging the Drug Products for Commercialization and use in the Territory as further set forth in and in accordance with Section 2.2.6 of the License Agreement. The Delivery of Drug Product will be performed by Supplier using Europallet (EPAL).

5.6

Shipping/Insurance . Supplier shall be responsible for procuring that its CDMOs obtain all licenses or other authorizations required for the Manufacture of the Product for supply to Purchaser in accordance with the terms of this Supply Agreement. Supplier shall be duly authorized for activities under its responsibility under this Supply Agreement. Purchaser shall be responsible for obtaining all licenses or other authorizations for the exportation of Products from the country of the Delivery Location and importation of the Products into destination country, and shall contract for shipping and insurance of the Products from the Delivery Location, [***].

All freight, insurance and other shipping expenses, as well as any special packing expense, shall be paid by [***]. [***] bear all applicable Taxes, duties and similar charges that may be assessed against any Products after Delivery.

5.7

Product Release for the Territory.

5.7.1

Supplier shall be responsible for the Drug Product manufacturing release for export to the Territory, as applicable, in line with cGMP, including providing the Batch Certificate upon Delivery. Supplier shall be responsible for providing Purchaser with the documents required by cGMP, as set out in the Quality Agreement. Supplier shall procure that the Product is Manufactured, and shall supply the Product, in each case, in compliance with cGMP.

5.7.2

Purchaser shall be responsible for all post-production release, including QP release and certification of the Drug Product for Commercialization and use in the Territory. Purchaser shall be responsible for and shall perform all QP and commercial release requirements for use and commercialization of the Product in the Territory as specified under Applicable Law and as set forth in the Quality Agreement.

PRODUCT ACCEPTANCE, NON-CONFORMING PRODUCT AND SHORTFALLS

6.1

Acceptance; Rejection . Purchaser shall not be entitled to reject any Delivery of Product except in accordance with this Clause 6. For the avoidance of doubt, if Purchaser fails to inspect the Product or notify Supplier within the agreed timeframes, Purchaser shall be deemed to have accepted the relevant Delivery of Product.

6.2

Residual Shelf Life Requirement. With the exception of any Delivery of Drug Product made with respect to Purchaser’s first Purchase Order during the Supply Term, for each Delivery of Drug Product made during the Supply Term, at the time of Delivery, no more than [***] of the Drug Product’s total registered shelf life approved in the Specifications for the applicable Drug Product will have expired, unless an alternative residual shelf life requirement is agreed by the Parties with respect to a particular Purchase Order (“Residual Shelf Life Requirement”). In the event that Drug Products cannot be Delivered meeting such Residual Shelf Life Requirement, Supplier shall promptly inform Purchaser in writing before confirming any Delivery pursuant to Clause 5.2.2, and Purchaser may cancel such Purchase Order. For the avoidance of doubt, the Residual Shelf Life Requirement shall not apply to any Delivery of Drug Product made with respect to Purchaser’s first Purchase Order. For any Delivery of Drug Product made with respect to Purchaser’s first Purchase Order during the Supply Term, at the time of Delivery, unless there is a major Manufacturing deviation impacting the shelf life of such Drug Product, no more than [***] of the Drug Product’s total registered shelf life approved in the Specification for the applicable Drug Product will have expired.

6.3

Inspection. Purchaser shall exercise reasonable diligence to identify any Shortfall or Defects with any Delivery of Product after receipt by Purchaser. Without limiting the foregoing, all Product Delivered to Purchaser or its designee shall be subject to Initial Inspection by Purchaser. For the purposes of this Supply Agreement, “Initial Inspection” shall mean:

6.3.1

comparing the applicable Purchase Order against the documentation accompanying the Delivery to verify that the identity, quantity and exterior Product Labelling comply with the Product ordered;

6.3.2

visually inspecting the exterior of the Product to verify that the Delivery appears to be in good condition; and

6.3.3

to the extent not already reviewed by Purchaser, reviewing the Batch Certificate, Certificate of Analysis and any other delivery documentation provided to confirm compliance with the applicable Specifications.

6.3.4

For clarity, Purchaser shall not be required to perform any analytical control on the Product nor direct inspection as part of the Initial Inspection.

6.4

Conforming Products . Supplier warrants that Products supplied by Supplier pursuant to this Supply Agreement shall conform to the applicable Specifications at the time of Delivery by Supplier. Supplier shall [***] procure that the Products are Manufactured in all material respects in compliance with:

6.4.1

the applicable Specifications;

6.4.2

cGMP;

6.4.3

the Quality Agreement; and

6.4.4

all Applicable Law in the countries in which they are Manufactured.

6.5

Shortfall or Non-Conforming Product .

6.5.1

Purchaser shall, within [***] of Purchaser first becoming aware, notify Supplier of any Shortfall or Non-Conforming Product in any Delivery of Products, and shall provide Supplier with a reasonably detailed written report of the alleged Shortfall or Non-Conforming Product, in each case, promptly thereafter and not later than [***] after Delivery, for any Shortfall or any Non-Conforming Product that is reasonably discoverable within such time period; or, for any Defect that is not reasonably discoverable within such time period, [***] after such Defect has become apparent to Purchaser, but in any event no later than the actual date of expiry of the shelf life of the applicable Product.

6.5.2

With respect to any alleged Non-Conforming Product, until such time it is determined whether such Product is Non-Conforming Product in accordance with this Clause 6, Purchaser shall (a) maintain a “hold” or “unpassed” status on such Product, (b) not release such Product into passed inventory of Purchaser and (c) hold and maintain such Product in appropriate storage and temperature control conditions, including any such storage conditions set forth in the applicable Specifications.

6.6

Supplier Review and Inspection. Supplier shall review any written notice of (a) a Shortfall within [***] after or (b) Non-Conforming Product within [***] after, as applicable, the receipt of Purchaser’s notice in accordance with Clause 6.5. All claims made by Purchaser regarding a Shortfall or Non-Conforming Product shall be handled on a case-by-case basis, and during the above review time (no more than [***] for Shortfalls and no more than [***] for Non-Conforming Product) Supplier shall have the right to inspect any quantity of Products involved. Purchaser shall comply with Supplier’s reasonable requests with respect to Supplier’s review and inspection, including by providing applicable documents, samples and quantities of the alleged Non-Conforming Product to Purchaser. Supplier shall finalize its review of any written notice of a Shortfall and shall [***] finalize its review of any written notice of Non-Conforming Product within the time periods set forth in this Clause 6.6.

6.7

Disagreement . If the Parties disagree as to whether there is a Shortfall or a Product is a Non-Conforming Product, which disagreement cannot be resolved by the Parties within [***].

6.8

[***]

6.9

Remedies for Shortfall or Defect. Provided Purchaser has duly notified Supplier of a Shortfall or a Non-Conforming Product in accordance with Clause 6.5 and Supplier agrees following its review of such written notice, and inspection (if any) of alleged Shortfall or Non-Conforming Product, pursuant to Clause 6.6 with such Shortfall or Non-Conforming Product identified by Purchaser, or such Shortfall or Non-Conforming Product is finally determined pursuant to Clause 6.7 or Clause 6.8:

6.9.1

Subject to Clause 6.9.2, if such Shortfall or Non-Conforming Product is determined to be the result of Supplier’s gross negligence, willful misconduct, or breach of Clause 5.1, Clause 5.2.1, Clause 5.2.2, Clause 5.3, Clause 5.5 or breach of Applicable Law, then:

(a)

in the case of any Shortfall, [***]:

(i)

[***]; or

(ii)

[***]

(b)

in the case of any Non-Conforming Product,

(i)

[***]; and

(ii)

[***].

6.9.2

[***].

6.10

Sole Remedy for Shortfall or Non-Conforming Product . Subject to Clause 15, the rights and remedies set out in this Clause 6 shall be Purchaser’s sole right and remedy in relation to the Delivery of any Shortfall or Non-Conforming Product.

PRICE

7.1

Product Price. The Price payable by Purchaser for Product Delivered hereunder shall be equal to [***] of the COGS of such Product. The calculation of COGS and Price payable as of the Effective Date by Purchaser under this Supply Agreement for the Products are specifically identified in Schedule 7.1.

7.2

Supplier Price Changes. [***].

7.3

[***].

7.4

[***].

7.5

CapEx Reporting. [***].

7.6

Currency. Unless otherwise agreed between the Parties, all amounts to be paid by Purchaser under this Supply Agreement shall be payable in United States dollars ($).

7.7

Audit. At the request of Purchaser, Supplier shall permit an independent auditor designated by Purchaser at reasonable times and upon reasonable notice which, in no event, shall be less than [***] Business Days in advance, to audit the books and records to ensure the accuracy of all reports and payments made hereunder. Except as provided below, the cost of this audit shall be borne by [***].

INVOICING AND PAYMENT

8.1

Invoicing. All Purchase Orders under this Supply Agreement shall be invoiced at the time Supplier accepts such Purchase Order in accordance with Clause 4.4 at the applicable Price. Any other costs, expenses or other sums which may be chargeable by Supplier under this Supply Agreement shall be invoiced by Supplier in arrears, on a monthly or a less frequent basis as Supplier may (in its sole discretion) decide, however, not less frequent than quarterly.

8.2

Payment. Subject to Clause 8.1, Purchaser shall pay to Supplier the amount set forth in each invoice submitted under this Supply Agreement [***] days after Purchaser’s receipt of such invoice. All payments due to Supplier under this Supply Agreement are exclusive of any customs or excise duties that may be chargeable, which Purchaser shall pay in addition at the rate and in the manner for the time being prescribed by Applicable Law. Without limiting the foregoing, in the event that Purchaser has not paid in full any amount due under the invoice issued with respect to a Purchase Order in accordance with this Clause 8.2, then, without limiting Clause 8.3, Supplier may delay or otherwise withhold Delivery of any Product under such Purchase Order until such time that Purchaser has paid such invoice in full in accordance with this Clause 8.2.

Any delay or withholding of a Delivery arising from any such non-payment shall not be deemed to be a breach of Supplier’s obligations with respect to Delivery under Clause 5.2.

8.3

Failure to Timely Pay . If a Party fails to pay any amount payable under this Supply Agreement by the due date for payment, including for any Purchase Order that Purchaser cancels (in accordance with Clause 4.7), then:

8.3.1

interest shall accrue on that amount for the period beginning on the due date for payment and ending on the date of actual payment (both before and after judgment) at a monthly rate of [***]. Interest shall be calculated for the actual number of days elapsed, shall accrue from day to day, and shall be compounded monthly; and

8.3.2

if amounts are payable by Purchaser after the timeframe set forth in Clause 8.2, without prejudice to Clause 8.3.1 and subject to giving [***] prior written notice of its intention to do so (such notice, a “Payment Breach Notice”), and provided that such amounts are undisputed, Supplier shall be entitled, at its election, to (i) suspend any of its obligations under this Supply Agreement (including any Delivery obligations) until such time as any unpaid amounts have been paid in full or (ii) terminate this Supply Agreement in full in accordance with Clause 18.2 (with such failure to pay being deemed a material breach of Purchaser’s material obligations).

8.4

Tax Generally . Except as provided in Clause 8.5 and Clause 8.6, each Party shall be solely responsible for paying any and all Taxes (other than withholding Taxes required by Applicable Law to be deducted from payments and remitted by the other Party) levied on account of, or measured in whole or in part by reference to, any income it receives or is deemed to be receiving for Tax purposes in connection with this Supply Agreement.

8.5

Withholding Taxes. Any payments made pursuant to this Supply Agreement to a Party or its applicable Affiliate (each, a “Payee”) shall be made free and clear, and without any deduction or withholding on account of Taxes unless such deduction or withholding is required under Applicable Law. If one Party (or its Affiliate) (the “Withholding Agent”) is required to deduct or withhold any Tax from any payment hereunder to the Payee, then the Withholding Agent shall (a) be authorized to deduct and withhold such Tax in accordance with the Applicable Law, (b) timely remit the amount of Tax deducted and withheld to the applicable Governmental Entity and (c) provide the Payee within a reasonable period of time evidence that such Tax has been so remitted for the benefit of the Payee. The Parties shall, and shall cause their respective Affiliates to, cooperate reasonably with each other to minimize the amount required to be deducted or withheld from any payment to a Payee, to the extent permitted by Applicable Law. If a Payee is entitled under an applicable income tax treaty to a reduction of the rate of, or an exemption from, applicable withholding Tax, such Payee shall deliver to the Withholding Agent or the appropriate Governmental Entity (with the assistance of the Withholding Agent, if reasonably required and is requested in writing) the prescribed forms necessary to obtain such reduction of or exemption from withholding Tax. Such forms shall be delivered at [***] prior to payment of any such applicable Tax. The Withholding Agent shall transfer to the applicable Payee within [***] of receipt any amount of Tax previously deducted or withheld in respect of any payment made pursuant to this Supply Agreement to the extent any amount of such Tax is refunded in whole or in part to the Withholding Agent by the applicable Governmental Entity or other fiscal authority, plus any interest in respect of such refunded amount of Tax received by the Withholding Agent from such Governmental Entity or fiscal authority.

8.6

Indirect Tax. All amounts mentioned in and all payments made under this Supply Agreement are stated exclusive of Indirect Tax. If any Indirect Tax is required by Applicable Law and chargeable by Supplier in respect of any such payments, Purchaser shall pay such Indirect Tax at the applicable rate in respect of any such payments following the receipt, where applicable and charged by Supplier, of an Indirect Tax invoice in the appropriate form issued by Supplier in respect of those payments, such Indirect Tax to be payable on the later of (a) the due date of the payment of the payments to which such Indirect Tax relates, and (b) the receipt of the respective Indirect Tax invoice in the appropriate form issued by Supplier.

If and to the extent any invoice is not initially issued in an appropriate form, the Parties shall cooperate to provide such information or assistance as may be necessary to enable the issuance of such invoice consistent with Indirect Tax requirements. If the Indirect Taxes actually chargeable in respect of any payments or consideration turn out to be higher or lower than the amount shown on the relevant invoice (including if no Indirect Taxes have been invoiced at all), the Parties shall fully cooperate with each other to reflect a proper Indirect Tax treatment without undue delay.

REPRESENTATIONS AND WARRANTIES

9.1

Representations and Warranties. Supplier and Purchaser each represents and warrants to the other that:

9.1.1

Organization. It is a corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction of its organization, and has all requisite power and authority, corporate or otherwise, to execute, deliver, and perform this Supply Agreement.

9.1.2

Authorization. The execution and delivery of this Supply Agreement and the performance by it of the transactions contemplated hereby have been duly authorized by all necessary corporate action, and do not violate (a) such Party’s charter documents, bylaws, or other organizational documents, (b) in any material respect, any agreement, instrument, or contractual obligation to which such Party is bound, (c) any requirement of any Applicable Law or (d) any order, writ, judgment, injunction, decree, determination, or award of any court or Governmental Entity presently in effect applicable to such Party.

9.1.3

Binding Agreement. This Supply Agreement is a legal, valid, and binding obligation of such Party enforceable against it in accordance with its terms and conditions, subject to the effects of bankruptcy, insolvency, or other laws of general application affecting the enforcement of creditor rights, judicial principles affecting the availability of specific performance, and general principles of equity (whether enforceability is considered a proceeding at law or equity).

9.1.4

No Inconsistent Obligation. It is not under any obligation, contractual or otherwise, to any Person that conflicts with or is inconsistent in any material respect with the terms of this Supply Agreement, or that would impede the diligent and complete fulfillment of its obligations hereunder.

9.2

Exclusions. THE EXPRESS REPRESENTATIONS AND WARRANTIES STATED IN THE FIRST SENTENCE OF CLAUSE 6.4 AND CLAUSE 9.1, ARE IN LIEU OF ALL OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.

10.

MANUFACTURING TRANSFER

10.1

Manufacturing Transfer. Subject to the remainder of this Clause 10, unless otherwise agreed by the Parties, after the Effective Date, the Parties will initiate the process to have the Drug Products (but not any API, nor any of the API in such Drug Products) Manufactured by Purchaser or by a Third Party contract manufacturer appointed by Purchaser (the “Manufacturing Transfer”), and Purchaser may request that Supplier provide reasonable assistance to Purchaser in respect thereof, as and to the extent set forth in Clause 10.2.

10.1.1

Any activities under, or the process of, the Manufacturing Transfer shall not adversely affect Supplier’s manufacturing capacity, operational resources or commitments to other customers.

10.1.2

For the avoidance of doubt, both Parties shall continue to comply with the terms and conditions of this Supply Agreement, including with respect to Drug Product Forecasts, Purchase Orders, Price Changes and minimum order quantities, during any period following initiation of the Manufacturing Transfer pursuant to this Clause 10.1 and until the effective date of termination of this Supply Agreement. If, due to timing of completion of the Manufacturing Transfer, Purchaser delivers an expedited Purchase Order with a requested delivery date before the [***] month after the month in which such Purchase Order was placed, or a Purchase Order otherwise not complying with the requirements of Clause 4.2 or Clause 4.3, Supplier shall promptly respond to Purchaser in writing if it accepts or rejects such Purchase Order, and, if accepted, Supplier’s proposed Price and the Agreed Delivery Date for such Purchase Order. Purchaser shall respond to Supplier’s proposals within [***] Business Days confirming whether it accepts or rejects such proposals in accordance with Clause 4.6.

10.1.3

Notwithstanding Section 3.3.1(i) of the License Agreement, Supplier hereby grants to Purchaser a non-exclusive, non-transferable (except in accordance with Clause 22.4), non-sublicensable (except to permitted subcontractors under Section 2.5 of the License Agreement) license under the Licensor Patents and the Licensor Know-How (a) to Manufacture or have Manufactured finished Drug Product (in tablet form, and only in the applicable dosage and formulation as set forth in (or anticipated by) the License Agreement) from or using only (i) the Drug Product or (ii) with respect to any obicetrapib in such finished Drug Product, the Commercial API, in each case ((i) and (ii)), supplied to Purchaser by Supplier under this Supply Agreement; and (b) to use the Technical API supplied under this Supply Agreement solely for non-commercial (i) research or (ii) equipment testing purposes, in each case ((i) and (ii)), only as part of the Manufacturing Transfer and for no other use or purpose. For the avoidance of doubt, Purchaser shall not use the Technical API for the Manufacture of any Drug Product that may be released for Commercialization or use in the Territory.

10.2

Manufacturing Transfer Activities. The Manufacturing Transfer shall be in respect of the transfer of the Manufacture and supply of Drug Products in tablet form only, and in the applicable dosage and formulation as set forth in (or anticipated by) the License Agreement, and in no event shall the Manufacturing Transfer be in respect of API other than through the supply of Technical API solely for non-commercial (i) research or (ii) equipment testing purposes (and for no other use or purpose) under Clause 10.2.4. Supplier’s assistance with respect to the Manufacturing Transfer shall, unless otherwise agreed by the Parties, be limited to:

10.2.1

[***]

10.2.2

[***];

10.2.3

[***]; and

10.2.4

[***]:

(a)

[***]; and

(b)

[***]; and

10.2.5

[***].

10.3

Covenant. [***].

10.4

Costs of Manufacturing Transfer . [***].

11.

REGULATORY MATTERS

11.1

Quality Agreement. The Parties shall enter into a commercial quality agreement (the “Quality Agreement”) on or around the date hereof. Such Quality Agreement is intended to identify the Parties’ respective quality compliance responsibilities and shall be based on Purchaser’s template.

Supplier and Purchaser shall perform their respective obligations and comply with all provisions of the Quality Agreement.

11.2

Recalls. Recalls, including costs in respect thereof, shall be governed by Section 2.2.5 and Section 2.3.3 of the License Agreement and the Quality Agreement.

11.3

Recordkeeping. The respective responsibilities and rights of each Party in relation to records and documentation with respect to supply of Product are further set out in the Quality Agreement.

11.4

cGMP Audits. Unless otherwise set out in the Quality Agreement, Purchaser shall have the right to audit, on at least [***] prior written notice, (a) the sites of registered starting materials manufacturers, API manufacturers, CDMOs and Supplier, (b) warehouses where the Product may be stored, and (c) all Facilities listed in the Marketing Authorization or involved in the Product Manufacture and supply, [***]. Any such audit shall take place during normal business hours, and last for no more than [***], include no more than [***] from Purchaser or its representatives, unless for a particular audit additional numbers of days or persons are agreed by the Parties (subject to such additional numbers being permitted by Supplier’s manufacturers’ or its CDMOs’), and not interfere with Supplier’s (or its manufacturers’ or its CDMOs’) normal operations. Where significant compliance issues are detected, Supplier shall [***] to carry out specific, for cause audits upon short notice, designed to lead to the resolution of such compliance issues. [***].

11.5

Product Quality Review. Supplier shall prepare and share with Purchaser any PQR reports related to the Product within [***] from the end of the assessment period. [***].

11.6

[***].

11.7

Pharmacovigilance. The reporting of adverse events, or any other pharmacovigilance matters, in relation to any Product supplied to Purchaser under this Supply Agreement will be governed by a separate pharmacovigilance agreement to be entered into by the Parties pursuant to Section 7.1 of the License Agreement.

12.

COMPLIANCE

12.1

Compliance with Applicable Law. In performing their respective obligations under this Supply Agreement, each Party shall comply with Applicable Law during the Supply Term.

12.2

Anti-Bribery and Anti-Corruption Compliance. Without prejudice to Clause 12.1, the provisions of Section 9.3 (Anti-Bribery and Anti-Corruption Compliance) of the License Agreement, together with the defined terms provided in the License Agreement to the extent necessary to interpret the Parties’ rights and obligations under such provisions, apply to this Supply Agreement mutatis mutandis and are hereby incorporated into this Supply Agreement by reference.

13.

CONFIDENTIALITY

13.1

Confidentiality. The provisions of Section 8.1 (Confidentiality Obligations), Section 8.2 (Permitted Disclosures) and Section 8.3 (Use of Name) of the License Agreement, together with the defined terms provided in the License Agreement to the extent necessary to interpret the Parties’ rights and obligations under such provisions, apply to this Supply Agreement mutatis mutandis with respect to any Confidential Information disclosed by one Party to the other under or in connection with this Supply Agreement and are hereby incorporated into this Supply Agreement by reference. For clarity, each Party may disclose all or any part of the Confidential Information disclosed pursuant to this Supply Agreement to its Affiliates, and to its and its Affiliates’ respective Personnel and Third Party contractors, including CDMOs, in accordance with and subject to Section 8.2.4 of the License Agreement.

13.2

Press Releases; Public Announcements . Purchaser and Supplier agree not to issue any press releases or public announcements concerning this Supply Agreement (and to ensure that their respective Affiliates do not do so) without the prior written consent of the other Party to the form, timing and content of any such release or announcement, except as required by Applicable Law, including disclosure required by any securities exchange.

14.

INDEMNITIES

14.1

Indemnification of Supplier. Purchaser shall indemnify and hold Supplier and its Affiliates harmless from and against any and all Losses arising from any claims from Third Parties (each a “Third Party Claim”) based on or deriving from [***].

14.2

Indemnification of Purchaser. Supplier shall indemnify and hold Purchaser and its Affiliates harmless from and against all Losses arising from Third Party Claims based on or deriving from [***].

14.3

Indemnification Procedures. The provisions of Section 10.3 (Notice of Claim) and Section 10.4 (Control of Defense) of the License Agreement, together with the defined terms provided in the License Agreement to the extent necessary to interpret the Parties’ rights and obligations under such provisions, apply to this Supply Agreement mutatis mutandis with respect to any claim for indemnification pursuant to Clause 14.1 or Clause 14.2 and are hereby incorporated into this Supply Agreement by reference.

15.

LIABILITY

15.1

Disclaimer. Except to the extent set out expressly in this Supply Agreement, all conditions, warranties or other terms which might have effect between the Parties or be implied or incorporated into this Supply Agreement (whether by statute, common law or otherwise) are hereby excluded to the fullest extent permitted by Applicable Law. Without prejudice to the general nature of the previous sentence, unless this Supply Agreement specifically states otherwise, Supplier does not make any representations or warranties with respect to any Product or Technical API, including any representations or warranties as to non-infringement or fitness for a particular purpose.

15.2

Limitation of Liability . TO THE EXTENT PERMITTED BY LAW, NOTWITHSTANDING ANY OTHER PROVISION CONTAINED HEREIN, UNLESS RESULTING FROM [***].

15.3

Maximum Liability . TO THE EXTENT PERMITTED BY LAW, NOTWITHSTANDING ANY OTHER PROVISION CONTAINED HEREIN, UNLESS RESULTING FROM [***], NOTWITHSTANDING ANY OTHER PROVISION CONTAINED HEREIN, NO LIMITATION OF LIABILITY SHALL APPLY WITH RESPECT TO ANY LIABILITY WHICH MAY NOT BE LIMITED OR EXCLUDED BY LAW.

15.4

Recovery of Damages. Neither Party shall be entitled under any provision of this Supply Agreement or the License Agreement to recover damages, or obtain payment, reimbursement, restitution or indemnity more than once in respect of the same loss, shortfall, damage, deficiency, breach or other event or circumstance.

15.5

Determination of Losses. [***].

16.

INSURANCE

16.1

Insurance. Without limiting its obligations and liability under this Supply Agreement, each Party shall effect and maintain, at its own expense, with reputable insurance companies, a third party general and a product liability insurance policy with a limit of liability not lower than [***] or the equivalent amount in local currency for any one occurrence or series of occurrences arising out of any one event or series of events. The policies shall also cover expenses incurred by third parties for the recall of products due to the other Party’s fault with a sublimit not lower [***] or the equivalent amount in local currency.

The policies shall be effective and maintained with reputable insurance companies with “S&P, Fitch and AM Best financial rating” not lower than “BBB” or “Moody’s financial rating” not lower than “Baa2”.

16.1.1

Any deductibles, policy exclusions or uncovered risks will remain the sole costs and expenses of the Party that subscribed to such policy.

16.1.2

Notwithstanding the foregoing, either Party shall maintain such insurance coverage during the Supply Term and, thereafter, for a minimum of [***] after the expiration or termination of this Supply Agreement.

16.1.3

Upon request of a Party, the other Party shall provide the requesting Party with a certificate of insurance issued by the insurer or by the broker, which shall include the details of its insurance policy, including, at least, the name of the insurer, the insured business activity, the policy number, the effective date, the expiration date and the limits of liability applied.

16.1.4

If either Party fails to maintain in force any of its own insurance policies in accordance with this Clause 16.1, the other Party shall have the right (but not the obligation) to maintain any relevant insurance coverage by paying the relevant premiums in place of the defaulting Party, with the right to be fully reimbursed by the Party which has failed to maintain the policies required under this Supply Agreement.

17.

FORCE MAJEURE

17.1

Force Majeure . If a Party is prevented from or delayed in performing any of its obligations under this Supply Agreement by a Force Majeure then:

17.1.1

the relevant obligations under this Supply Agreement shall be suspended for as long as the Force Majeure continues and the Party shall not be in breach of this Supply Agreement or otherwise liable for any such failure or delay in the performance of such obligations;

17.1.2

Supplier may, at its sole discretion, procure its CDMOs continue to store or procure the storage of any Product that would otherwise be supplied hereunder if not for the applicable Force Majeure event (including any components thereof) for so long as the Force Majeure continues, and Purchaser shall be liable for all related costs and expenses (including storage, shipping and insurance) with respect thereto;

17.1.3

as soon as reasonably practicable after the start of the Force Majeure, the Party shall notify the other of the nature of the Force Majeure, its anticipated duration, the actions being taken to avoid or minimize its effects, and the likely effects of the Force Majeure on its ability to perform its obligations under this Supply Agreement; and

17.1.4

subject to Clause 18.5, as soon as reasonably practicable after the end of the Force Majeure, it shall notify the other Party that the Force Majeure has ended and shall resume performance of its obligations under this Supply Agreement.

18.

TERM AND TERMINATION

18.1

Term . This Supply Agreement commences and takes effect on the Effective Date and shall, unless terminated earlier in accordance with this Clause 18, continue in effect until the termination or expiration of the License Agreement pursuant to the terms thereof (such period, the “Supply Term”).

18.2

Termination for Material Breach. If either Party (the “Non-Breaching Party”) believes that the other Party (the “Breaching Party”) has materially breached one or more of its material obligations under this Supply Agreement, including a payment breach in accordance with Clause 8.3.2 or a breach of Purchaser’s covenants set forth in Clause 10.3, then the Non-Breaching Party may deliver notice of such material breach to the Breaching Party (a “Default Notice”).

If the Breaching Party does not dispute that it has committed a material breach of one or more of its material obligations under this Supply Agreement, and the Breaching Party fails to cure such breach, or fails to take steps as would be considered reasonable to effectively cure such breach, within [***] after receipt of the Default Notice, or within [***] after receipt of a Payment Breach Notice, then the Non-Breaching Party may terminate this Supply Agreement upon written notice to the Breaching Party.

18.3

Termination for Insolvency. In the event that either Party (a) files for protection under bankruptcy or insolvency laws, (b) makes an assignment for the benefit of creditors, (c) appoints or suffers appointment of a receiver or trustee over substantially all of its property that is not discharged within [***] after such filing, (d) proposes a written agreement of composition or extension of its debts, (e) proposes or is a party to any dissolution or liquidation, (f) files a petition under any bankruptcy or insolvency act or has any such petition filed against that is not discharged within [***] days of the filing thereof or (g) admits in writing its inability generally to meet its obligations as they fall due in the general course, then the other Party may, to the extent permissible by any Applicable Law, terminate this Supply Agreement in its entirety effective immediately upon written notice to such Party.

18.4

Termination for Convenience. Supplier shall have the right to terminate this Supply Agreement at its sole discretion upon one hundred twenty (120) days’ written notice to Purchaser; provided that the effective date of termination following such one hundred twenty (120) days’ written notice to Purchaser is after the earlier of (a) completion of the Manufacturing Transfer and (b) two (2) years after initiation of the Manufacturing Transfer pursuant to Clause 10.1.

18.5

Termination for Force Majeure . Any Party shall have the right to terminate this Supply Agreement upon written notice to the other Party if a Force Majeure is ongoing for six (6) months or longer.

19.

EFFECTS OF TERMINATION

19.1

Effects of Termination.

19.1.1

Expiry or termination of this Supply Agreement for any reason shall be without prejudice to either Party’s other rights and remedies or to any accrued rights and liabilities as the date of such expiry or termination.

19.1.2

Within [***] following the expiration or termination of this Supply Agreement, each Party shall either, at the other Party’s option (a) return to the other Party all Confidential Information received from the other Party under this Supply Agreement to which such Party does not otherwise retain rights under this Supply Agreement or the License Agreement or (b) destroy such Confidential Information, except in either case ((a) or (b)), one (1) copy of such Confidential Information, which may be retained for archival purposes.

19.1.3

If this Supply Agreement is terminated in its entirety other than due to: (a) Purchaser’s material breach pursuant to Clause 18.2, (b) for either Party’s insolvency pursuant to Clause 18.3 or (c) for either Party’s Force Majeure pursuant to Clause 18.5, then Supplier shall complete any Purchase Orders for any Product accepted prior to the date of receipt of notice of such termination and Purchaser shall be required to accept delivery and make payment for such Product in accordance with the terms and conditions of this Supply Agreement; [***].

19.1.4

If this Supply Agreement is terminated due to (a) Purchaser’s material breach pursuant to Clause 18.2, (b) for either Party’s insolvency pursuant to Clause 18.3 or (c) for either Party’s Force Majeure pursuant to Clause 18.5, then, [***].

19.1.5

If this Supply Agreement is terminated by Purchaser due to Supplier’s material breach pursuant to Clause 18.2 and Purchaser continues to comply with its requirements under this Supply Agreement, then [***].

19.1.6

If Supplier provides notice of termination for convenience pursuant to Clause 18.4, Purchaser may upon receipt of such notice of termination, [***].

19.2

Survival. Any provision of this Supply Agreement which expressly or by implication is intended to come into or continue in force on termination or expiry of this Supply Agreement, including Clauses [1 (Definitions and Interpretation), 4.4 (CapEx) 4.6 (Amendments to Purchase Order, to the extent any Purchase Orders are outstanding), 4.7 (Cancellation, to the extent any Purchase Orders are outstanding), 5 (Delivery, to the extent any Purchase Orders are outstanding), 6 (Product Acceptance, Non-Conforming Product and Shortfalls, to the extent any Purchase Orders are outstanding), 7 (Price, to the extent any invoices are outstanding), 8 (Invoicing and Payment), 9 (Representations and Warranties), 10.2 (Manufacturing Transfer Activities) (only upon termination by Purchaser pursuant to Clause 18.2 or Clause 18.3 or by Supplier pursuant to Clause 18.4, to the extent necessary to give effect to Clause 10.1 and until the completion of the Manufacturing Transfer initiated pursuant thereto), 11.2 (Recalls), 13 (Confidentiality, for the relevant time period for such provisions as set out in the License Agreement), 14 (Indemnities), 15 (Liability), 16 (Insurance, for the time period set out therein), 19 (Effects of Termination), 21 (Notices), 22 (Miscellaneous)]1 shall remain in full force and effect.

20.

INDEPENDENT CONTRACTORS

20.1

Independent Contractors. Supplier is acting as an independent contractor under this Supply Agreement. Nothing in this Supply Agreement or any circumstances associated with it or its performance give rise to any relationship of agency, partnership or employer and employee between Purchaser and (a) Supplier, (b) Supplier’s Affiliates and (c) Supplier’s and its Affiliates’ respective Personnel directly and effectively involved, if any, in the performance of this Supply Agreement, nor authorize either Party to make or enter into any commitments for or on behalf of the other Party.

21.

NOTICES

21.1

Notice Requirements . Subject to Clause 21.2, all notices and communications relating to this Supply Agreement shall be in writing and delivered by hand or sent by post or e-mail to the Party concerned at the relevant address set out in this Clause 21 below (or such other address as may be notified from time to time in accordance with this Clause 21 by the relevant Party to the other Party). Any communication shall take effect:

(a)

if hand delivered, upon being handed personally to the addressee (or, where the addressee is a corporation, any one of its directors or its secretary) or being left in a letter box or other appropriate place for the receipt of letters at the relevant Party’s address as set out below;

(b)

if sent by first class registered post, at 10 a.m. on the second Business Day after posting or if overseas by international recorded post, at 10 a.m. on the fifth Business Day after posting;

(c)

if sent by internationally recognized courier service which provides for overnight delivery, at 10 a.m. on the second Business Day after such communication was provided to the courier for delivery; and

(d)

if sent by e-mail, when the e-mail is sent, provided that (i) a copy of the notice is sent by another method referred to in this Clause 21 within one (1) Business Day of sending the e-mail; or (ii) the recipient of the e-mail has sent a reply.

For notices to Supplier:

Chief Executive Officer

NewAmsterdam Pharma B.V.

20803 Biscayne Boulevard

Suite 105

Aventura, FL 33180

Attention: [***]

E-mail: [***]

with a copy (which shall not constitute notice) to each of the following:

Chief Manufacturing Officer, NewAmsterdam Pharma B.V.

NewAmsterdam Pharma Holding B.V.

Gooimeer 2-35

1411 DC Naarden

The Netherlands

Attention: [***]

E-mail: [***]

and:

Covington & Burling LLP

One CityCenter

850 Tenth Street, NW

Washington, D.C. 20001

Attention: [***]

E-mail: [***]

For notices to Purchaser:

A. Menarini International Licensing SA

12-C, Rue Impasse Drosbach - L-1882 - Luxembourg

Attention: [***]

E-mail: [***]

with a copy (which shall not constitute notice) to:

Address: [***]

Attention: [***]

E-mail: [***]

This Clause 21, however, shall not apply to the service of any proceedings or documents in any legal action, arbitration or any other form of dispute resolution procedure.

21.2

Day-to-day Communications. Day-to-day communications relating to the operation of this Supply Agreement, including Drug Product Forecasts and Purchase Orders shall be in writing (which for this purpose may include e-mail) and shall be delivered by e-mail to the alliance managers appointed by the Parties or to such other persons as those alliance managers may agree and shall be deemed to be delivered when the e-mail is sent or if outside normal business hours in the country where the recipient is generally located, the following working day in such country.

22.

MISCELLANEOUS

22.1

No Set Off. Purchaser shall not have any right of set-off (howsoever arising) in respect of any sums payable in connection with this Supply Agreement and all sums payable by Purchaser to Supplier under this Supply Agreement shall be paid in full without set-off, counterclaim or other deduction.

22.2

No License. Nothing in this Supply Agreement shall be deemed to constitute the grant of any license or other right in either Party to or in respect of any product, patent, trademark, Confidential Information, trade secret or other data or any other intellectual property of the other Party except as expressly set forth herein.

22.3

Export Control. This Supply Agreement is made subject to any restrictions concerning the export of products or technical information from the United States or other countries that may be imposed on the Parties from time to time. Each Party agrees that it will not export, directly or indirectly, any technical information acquired from the other Party under this Supply Agreement or any products using such technical information to a location or in a manner that at the time of export requires an export license or other governmental approval, without first obtaining the written consent to do so from the appropriate agency or other Governmental Entity in accordance with Applicable Law.

22.4

Assignment . Without the prior written consent of the other Party, such consent not to be unreasonably withheld, conditioned, or delayed, neither Party shall sell, transfer, assign, delegate, pledge, or otherwise dispose of, whether voluntarily, involuntarily, by operation of law or otherwise, this Supply Agreement or any of its rights or duties hereunder; provided, however, that Supplier may make such an assignment without Purchaser’s consent to its Affiliate or to a successor, whether in a merger, sale of stock, sale of assets or any other transaction, of the business to which this Supply Agreement relates. With respect to an assignment to an Affiliate, the assigning Party shall remain responsible for the performance by such Affiliate of the rights and obligations hereunder. Any attempted assignment or delegation in violation of this Clause 22.4 shall be void and of no effect. All validly assigned and delegated rights and obligations of the Parties hereunder shall be binding upon and inure to the benefit of and be enforceable by and against the successors and permitted assigns of Supplier or Purchaser, as the case may be. In the event either Party seeks and obtains the other Party’s consent to assign or delegate its rights or obligations to another Party, the assignee or transferee shall assume all obligations of its assignor or transferor under this Supply Agreement.

22.5

Severability . If any provision of this Supply Agreement is held to be illegal, invalid, or unenforceable under any present or future law, and if the rights or obligations of either Party under this Supply Agreement will not be materially and adversely affected thereby, (a) such provision shall be fully severable, (b) this Supply Agreement shall be construed and enforced as if such illegal, invalid, or unenforceable provision had never comprised a part hereof, (c) the remaining provisions of this Supply Agreement shall remain in full force and effect and shall not be affected by the illegal, invalid, or unenforceable provision or by its severance herefrom, and (d) in lieu of such illegal, invalid, or unenforceable provision, there shall be added automatically as a part of this Supply Agreement a legal, valid, and enforceable provision as similar in terms to such illegal, invalid, or unenforceable provision as may be possible and reasonably acceptable to the Parties. To the fullest extent permitted by Applicable Law, each Party hereby waives any provision of law that would render any provision hereof illegal, invalid, or unenforceable in any respect.

22.6

Governing Law, Jurisdiction and Service .

22.6.1

Governing Law and Jurisdiction. This Supply Agreement shall be governed by and construed in accordance with the laws of [***], excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of this Supply Agreement to the substantive law of another jurisdiction.

The Parties agree to exclude the application to this Supply Agreement of the United Nations Convention on Contracts for the International Sale of Goods. The Parties hereby irrevocably consent to the jurisdiction of [***], suit or proceeding (other than appeals therefrom) arising out of or relating to this Supply Agreement and agree not to commence any action, suit or proceeding (other than appeals therefrom) related thereto except in such courts. [***].

22.6.2

Service. [***].

22.7

Dispute Resolution. Except as provided in the first sentence of Clause 6.7 and Clause 6.8, if a dispute arises between the Parties in connection with or relating to this Supply Agreement or any document or instrument delivered in connection herewith (a “Dispute”), it shall be resolved pursuant to this Clause 22.7.

22.7.1

General. Any Dispute shall be referred to [***].

22.8

Entire Agreement; Amendments. This Supply Agreement, together with the Schedules attached hereto, sets forth and constitutes the entire agreement and understanding between the Parties with respect to the subject matter hereof and all prior agreements, understandings, promises, and representations, whether written or oral, with respect thereto are superseded hereby. Each Party confirms that it is not relying on any representations or warranties of the other Party except as specifically set forth in this Supply Agreement. No amendment, modification, release, or discharge shall be binding upon the Parties unless in writing and duly executed by authorized representatives of both Parties.

22.9

English Language. This Supply Agreement shall be written and executed in, and all other communications under or in connection with this Supply Agreement shall be in English language. Any translation into any other language shall not be an official version thereof, and in the event of any conflict in interpretation between the English version and such translation, the English version shall control.

22.10

Equitable Relief. [***].

22.11

Waiver and Non-Exclusion of Remedies. Any term or condition of this Supply Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. The waiver by either Party hereto of any right hereunder or of the failure to perform or of a breach by the other Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by such other Party whether of a similar nature or otherwise. The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by Applicable Law or otherwise available except as expressly set forth herein.

22.12

No Benefit to Third Parties. Covenants and agreements set forth in this Supply Agreement are for the sole benefit of the Parties hereto and their successors and permitted assigns, and they shall not be construed as conferring any rights on any other Persons.

22.13

Further Assurance. Each Party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents, and instruments, as may be necessary or as the other Party may reasonably request in connection with this Supply Agreement or to carry out more effectively the provisions and purposes hereof, or to better assure and confirm unto such other Party its rights and remedies under this Supply Agreement.

22.14

Counterparts; Execution. This Supply Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. This Supply Agreement may be executed by electronic verified signature (such as DocuSign), or electronically transmitted signatures and such signatures shall be deemed to bind each Party hereto as if they were original signatures.

IN WITNESS WHEREOF, the Parties have caused this Supply Agreement to be executed in two counterparts by their respective duly authorized representatives as of the date set forth at the beginning of this Supply Agreement.

[Signature pages follow]

EXECUTION:

     SIGNED for and on behalf of 
NewAmsterdam Pharma B.V.
Signature: 	/s/ Michael Davidson  
Name: Michael Davidson
Title: Chief Executive Officer
Authorized Signatory

    

[Signature Page to Supply Agreement]

SIGNED for and on behalf of
A. Menarini INTERNATIONAL LICENSING S.A.

Signature: [***]

Name: [***]

Title: [***]

Signature: [***]

Name: [***]

Title: [***]

[Signature Page to Supply Agreement]

Schedule 1

Facilities and Registered Batch Size


Product	Facility	Registered Batch Size
Obicetrapib Product	[***]	[***]
Ezetimibe Fixed Dose Combination Product	[***]	[***]

Schedule 2

Drug Product Specifications

The Drug Product Specifications shall detail the requirements that the Drug Product, or materials used or obtained during the manufacture, shall comply with. It is understood that the Drug Product Specifications are intended, subject to the change control process set forth in Clause 2.3 of this Supply Agreement, to be compliant with the technical and pharmaceutical specifications of the Purchaser Marketing Authorisation, as submitted or approved from time to time by the competent Regulatory Authority (detailing the manufacturing process, analytical controls and bulk specifications). Purchaser shall promptly provide to Supplier the technical and pharmaceutical specifications of the Drug Product set forth in the Purchaser Marketing Authorisation submitted or approved from time to time by the competent Regulatory Authority, and, to the extent such technical and pharmaceutical specifications require any changes to the Drug Product Specifications, such changes shall be implemented via, and subject to, the change control process set out in Clause 2.3.

The Drug Product Specifications shall also cover any additional approved specifications that may be agreed between the Parties under the Supply Agreement or the Quality Agreement.

The Drug Product Specifications are attached to the Quality Agreement.

Schedule 2.2

CDMOs

[***]

Schedule 4.1.1

Long Term Forecast

[***]

Schedule 4.1.2

Initial Forecast

[***]

Schedule 4.2

Initial Purchase Order Template

Schedule 7.1

Provisional COGS and Price

[***]

EX-10.2 3 nams-ex10_2.htm EX-10.2 EX-10.2

INDUCEMENT PLAN

NEWAMSTERDAM PHARMA COMPANY N.V.

INTRODUCTION

Article 1

1.1

This document sets out the Company’s inducement plan for prospective Employees who qualify as Eligible Participants. This Plan applies in addition, and without prejudice, to the Company’s long-term incentive plan, the Company’s supplementary long-term incentive plan and the Company’s roll-over option plan; the same applies to the Ordinary Shares reserved for issuance under Awards granted pursuant to this Plan.

1.2

The main purposes of this Plan are:

to provide a material inducement to prospective Employees to become Employees within the meaning of Nasdaq Listing Rule 5635(c)(4);

to attract, retain and motivate Participants with the qualities, skills and experience needed to support and promote the growth and sustainable success of the Company and its business; and

to incentivise Participants to perform at the highest level and to further the best interests of the Company, its business and its stakeholders.

DEFINITIONS AND INTERPRETATION

Article 2

2.1

In this Plan the following definitions shall apply:


Aggregate Share Pool	2,500,000 Shares
Article	An article of this Plan.
Award	A grant under this Plan in connection with the hiring of an Eligible Participant in the form of one or more Options, SARs, Shares of Restricted Stock, RSUs, Other Awards, or a combination of the foregoing.
Award Agreement	A written agreement between the Company and a Participant, in such form as may be approved by the Board or the Committee, evidencing the grant of an Award to such Participant and containing such terms as the Committee may determine, consistent with and subject to the terms of this Plan.
Bad Leaver	A Participant who ceases to be a service provider to the Company and its Subsidiaries for Cause, including a situation where (i) the Participant resigns and (ii) the Committee determines that an event has occurred with respect to that Participant which constitutes Cause.

83100978 M 54830419 / 3

     Board

     The Company’s board of directors.

     Cause

     With respect to a Participant, “cause” as defined in such Participant’s employment, service or consulting agreement with the Company or a Subsidiary, or if not so defined (and unless determined otherwise in the applicable Award Agreement or by the Committee):
a.	such Participant’s indictment for any crime which (i) constitutes a felony, (ii) has, or could reasonably be expected to have, an adverse impact on the performance of such Participant’s services to the Company and/or any Subsidiary or (iii) has, or could reasonably be expected to have, an adverse impact on the business and/or reputation of the Company and/or any Subsidiary;
b. such Participant having been the subject of any order, judicial or administrative, obtained or issued by any governmental or regulatory body for any securities laws violation involving fraud, market manipulation, insider trading and/or unlawful dissemination of non-public price-sensitive information;
c. such Participant’s wilful violation of the Company’s code of business conduct and ethics, insider trading policy or other internal policies and regulations established by the Company and/or any Subsidiary, in each case to the extent applicable to the Participant concerned;
d. gross negligence or wilful misconduct in the performance of such Participant’s duties for the Company and/or any Subsidiary or wilful or repeated failure or refusal to perform such duties;
e. material breach by such Participant of any employment, service, consulting or other agreement entered into between such Participant on the one hand and the Company and/or any Subsidiary on the other;
f. except with respect to U.S. Participants, conduct by such Participant which should be considered as an urgent cause within the meaning of Section 7:678 DCC, irrespective of whether that provision applies to such Participant’s relationship with the Company and/or any Subsidiary; and

    

      
     g. except with respect to U.S. Participants, such other acts or omissions to act by such Participant as reasonably determined by the Committee,
provided that the occurrence of an event described in paragraphs c. through e. above shall only constitute Cause if and when such event has not been cured or remedied by the relevant Participant within thirty days after the Company has provided written notice to such Participant.

     Change of Control

     The occurrence of any one or more of the following events:
a. the direct or indirect change in ownership or control of the Company effected through one transaction, or a series of related transactions within a twelve-month period, as a result of which any Person or group of Persons acting in concert, directly or indirectly acquires (i) beneficial ownership of more than half of the Company’s issued share capital and/or (ii) the ability to cast more than half of the voting rights in a General Meeting;
b. at any time during a period of twelve consecutive months, individuals who at the beginning of such period constituted the Board cease to constitute a majority of members of the Board, provided that any new Director who was nominated for appointment by the Board by a vote of at least a majority of the Directors who either were Directors at the beginning of such twelve-month period or whose nomination for appointment was so approved, shall be considered as though such individual were a Director at the beginning of such twelve-month period;
c. the consummation of a merger, demerger or business combination of the Company or any Subsidiary with another Person, unless such transaction results in the shares in the Company’s capital outstanding immediately prior to the consummation of such transaction continuing to represent (either by remaining outstanding or by being converted into, or exchanged for, voting securities of the surviving or acquiring Person or a parent thereof) at least half of the voting rights in the General Meeting or in the shareholders’ meeting of such surviving or acquiring Person or 

    


	parent outstanding immediately after the consummation of such transaction; d. the consummation of any sale, lease, exchange or other transfer to any Person or group of Persons acting in concert, not being Subsidiaries, in one transaction or a series of related transactions within a twelve-month period, of all or substantially all of the business of the Company and its Subsidiaries; or e. subject to Article 10, such other event which the Committee reasonably determines to constitute a change of control in respect of the Company.
Committee	The compensation committee established by the Board.
Company	NewAmsterdam Pharma Company N.V.
DCC	The Dutch Civil Code.
Director	A member of the Board.
Effective Date	The date on which this Plan has been adopted by the Board.
Eligible Participant	Any newly hired (or newly rehired, after a bona fide period of non-employment, as determined by the Committee) Employee who satisfies the standards for inducement grants under Nasdaq Listing Rule 5635(c)(4).
Employee	Any Person who is a natural person, other than a Director, who is an employee or officer of the Company and/or a Subsidiary.
Exercise Date	The date on which an Award is duly exercised by or on behalf of the Participant concerned.
Exercise Price	The exercise price applicable to an Award.
FMV	The closing price of a Share on the relevant date (or, if there is no reported sale of Shares on such date, on the last preceding date on which any such reported sale occurred) on the principal stock exchange where Shares have been admitted for trading, unless determined otherwise by the Committee, provided, however, that the Committee shall exercise such discretion to determine otherwise with respect to Awards held by U.S. Participants only after giving due regard to the requirements of Sections 409A and 422 of the Code.
General Meeting	The Company’s general meeting of shareholders.


Good Leaver	A Participant who ceases to be a service provider to the Company and its Subsidiaries and who is not a Bad Leaver.
Grant Date	The date on which the Committee decides to grant an Award, or such later effective date applicable to such Award as may be determined by the Committee, thereby completing the Company’s corporate action necessary to create the legally binding right constituting the Award.
Option	The right to subscribe for, or otherwise acquire, one Plan Share.
Other Award	An Award which does not take the form of an Option, SAR, Share of Restricted Stock or RSU, and which may be denominated or payable in, valued in whole or in part by reference to, or otherwise based on or related to Shares or factors which may influence the value of Shares, including cash-settled financial instruments and financial instruments which are convertible into or exchangeable for Plan Shares.
Participant	The holder of an Award, including, as the context may require, the rightful heir(s) of a previous holder of such Award having acquired such Award as a result of the death of such previous holder.
Performance Criteria	The performance criteria applicable to an Award.
Person	A natural person, partnership, company, association, cooperative, mutual insurance society, foundation or any other entity or body which operates externally as an independent unit or organisation.
Plan	This inducement plan.
Plan Share	A Share underlying an Award.
Restricted Stock	Plan Shares subject to such restrictions as the Committee may impose, including with respect to voting rights and the right to receive dividends or other distributions made by the Company.
RSU	The right to receive, in cash, in assets, in the form of Plan Shares valued at FMV, or a combination thereof, the FMV of one Share on the Exercise Date.
SAR	The right to receive, in cash, in assets, in the form of Plan Shares valued at FMV, or a combination thereof, the excess of the FMV of one Share on the applicable Exercise Date over the applicable Exercise Price.


Section 409A IRC	Section 409A of the United States Internal Revenue Code of 1986, as amended, and the rules, regulations and guidance promulgated pursuant thereto (or any successor provision).
Section 457A IRC	Section 457A of the United States Internal Revenue Code of 1986, as amended, and the rules, regulations and guidance promulgated pursuant thereto (or any successor provision).
Securities Act	The U.S. Securities Act of 1933, as amended.
Share	An ordinary share in the Company’s capital.
Subsidiary	A subsidiary of the Company within the meaning of Section 2:24a DCC.
Transfer	The (i) sale or assignment of, offer to sell, contract or agreement to sell, hypothecate, pledge, grant of any option to purchase or otherwise dispose of or agreement to dispose of, directly or indirectly, or establishment or increase of a put equivalent position or liquidation with respect to or decrease of a call equivalent position within the meaning of Section 16 of the Securities and Exchange Act of 1934, as amended, and the rules and regulations of the United States Securities and Exchange Commission promulgated thereunder, with respect to, any security, (ii) entry into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of any security, whether any such transaction is to be settled by delivery of such securities, in cash or otherwise, or (iii) public announcement of any intention to effect any transaction specified in clause (i) or (ii).
U.S. Participant	A Participant who is either a U.S. resident or a U.S. taxpayer.

2.2

References to statutory provisions are to those provisions as they are in force and as amended from time to time.

2.3

Terms that are defined in the singular have a corresponding meaning in the plural.

2.4

Words denoting a gender include each other gender.

2.5

Except as otherwise required by law, the terms “written” and “in writing” include the use of electronic means of communication.

ADMINISTRATION

Article 3

3.1

This Plan shall be administered exclusively by the Committee. The Committee’s powers and authorities under this Plan include the authority to perform the following matters, in each case consistent with and subject to the terms of this Plan:

designating Persons to whom Awards are granted;

deciding to grant Awards;

determining the form(s) and type(s) of Awards being granted and setting the terms and conditions applicable to such Awards, including:

the number of Plan Shares underlying Awards;

ii.

the time(s) when Awards may be exercised or settled in whole or in part;

iii.

whether, to which extent, and under which circumstances Awards may be exercised or settled in cash or assets (including other Awards), or a combination thereof, in lieu of Plan Shares and vice versa;

iv.

whether, to which extent and under which circumstances Awards may be cancelled or suspended (subject to Article 8.2);

whether and to which extent Awards are subject to Performance Criteria and/or restrictive covenants (including non-competition, non-solicitation, confidentiality and/or Share ownership requirements);

vi.

the method(s) by which Awards may be exercised, settled or cancelled; and

vii.

whether, to which extent and under which circumstances, the exercise, settlement or cancellation of Awards may be deferred or suspended;

amending or waiving the terms applicable to outstanding Awards (including Performance Criteria), subject to the restrictions imposed by Article 9 and provided that no such amendment shall take effect without the consent of the affected Participant(s), if such amendment would materially and adversely affect the rights of the Participant(s) under such Awards, except to the extent that any such amendment is made to cause this Plan or the Awards concerned to comply with applicable law, stock exchange rules, accounting principles or tax rules and regulations;

making any determination under, and interpreting the terms of, this Plan, any rules or regulations issued pursuant to this Plan and any Award Agreement;

correcting any defect, supplying any omission or reconciling any inconsistency in the Plan or any Award Agreement;

settling any dispute between the Company and any Participant (including any beneficiary of his Awards) regarding the administration and operation of this Plan, any rules or regulations issued pursuant to this Plan, and any Award Agreement entered into with such Participant; and

making any other determination or taking any other action which the Committee considers to be necessary, useful or desirable in connection with the administration or operation of this Plan.

3.2

The Committee may issue further rules and regulations for the administration and operation of this Plan, consistent with and subject to the terms of this Plan.

3.3

All decisions of the Committee shall be final, conclusive and binding upon the Company and the Participants (including beneficiaries of Awards).

AWARDS

Article 4

4.1

Awards can only be granted to Eligible Participants.

4.2

No Award is intended to confer any rights on the relevant Participant except as set forth in the applicable Award Agreement. In particular, no Award should be construed as giving any Participant the right to remain employed by or to continue to provide services for the Company or any Subsidiary.

4.3

Awards shall be granted for no consideration or for such minimal cash consideration as may be required by applicable law.

4.4

Awards may be granted alone or in addition or in tandem with any other Award and/or any award under any other plan of the Company or any Subsidiary. Awards granted in addition or in tandem with any other Award and/or any award under any other plan of the Company or any Subsidiary may be granted simultaneously or at different times.

4.5

Each Award shall be evidenced by an Award Agreement entered into between the Company and the Participant concerned. Until an Award Agreement has been entered into between the Company and the relevant Participant, no rights can be derived from the Awards concerning such Participant.

4.6

Plan Shares, including Awards in the form of Shares of Restricted Stock, shall be delivered in such form(s) as may be determined by the Committee and shall be subject to such stop transfer orders and other restrictions as the Committee may deem required or advisable. Furthermore, the Committee may determine that certificates for such Shares shall bear an appropriate legend referring to the terms, conditions and restrictions applicable thereto.

4.7

The terms and conditions applicable to Awards, including the time(s) when Awards vest in whole or in part and any applicable Performance Criteria, shall be set by the Committee and may vary between Awards and between Participants, as the Committee deems appropriate. The Committee may also determine whether and under which circumstances Awards shall be settled automatically upon vesting, without being exercised by the Participant.

4.8

The term of an Award shall be determined by the Committee, but shall not exceed ten years from the applicable Grant Date. Unless determined otherwise by the Committee, if the exercise of an Award is prohibited by applicable law or the Company’s insider trading policy on the last business day of the term of such Award, such term shall be extended for a period of one month following the end of such prohibition.

4.9

Unless determined otherwise by the Committee, Awards cannot be transferred, pledged or otherwise encumbered, except by testament or hereditary law as a result of death of the Participant concerned.

4.10

If, as a result of changes in applicable law, accounting principles or tax rules and regulations, or due to a variation of the composition of the Company’s issued share capital (including a share split, reverse share split, redenomination of the nominal value, or as a result of a dividend or other distribution, reorganisation, acquisition, merger, demerger, business combination or other transaction involving the Company or a Subsidiary), an adjustment to this Plan, any Award Agreement and/or outstanding Awards is necessary to prevent dilution or enlargement of the benefits or potential benefits intended to be made available under this Plan, the Committee may adjust equitably any or all of:

the number of Plan Shares available under this Plan;

the number of Plan Shares underlying outstanding Awards; and/or the Exercise Price or other terms applicable to outstanding Awards.

4.11

Any rights, payments and benefits under any Award shall be subject to repayment and/or recoupment by the Company in accordance with applicable law, stock exchange rules and such policies and procedures as the Company may adopt from time to time.

TYPES OF AWARDS

Article 5

5.1

The Committee may grant Awards in the form of Options, SARs, Shares of Restricted Stock, RSUs, Other Awards or a combination of the foregoing. Options granted to U.S. Participants shall be Nonstatutory Stock Options, as defined and specified in Annex A.

5.2

Upon the exercise or settlement of vested Options, the Company shall be obliged to deliver to the Participant concerned (or the beneficiary of such Options, as applicable), the Plan Shares underlying such Options (unless otherwise set forth in the Award Agreement).

5.3

Upon the exercise or settlement of vested SARs, the Company shall be obliged to pay to the Participant concerned (or the beneficiary of such SARs, as applicable) an amount equal to the number of Plan Shares underlying such SARs multiplied by the excess, if any, of the FMV of one Share on the applicable Exercise Date over the applicable Exercise Price. The Company may satisfy such payment obligation in cash, in assets, in the form of Shares valued at FMV, or a combination thereof, at the discretion of the Committee.

5.4

The exercise by a Participant of his rights attached to Shares of Restricted Stock shall be subject to such restrictions as the Committee may impose, including with respect to voting rights and the right to receive dividends or other distributions made by the Company. Upon the vesting of Shares of Restricted Stock, any such restrictions and conditions shall lapse with respect to those Shares. If an Award in the form of Shares of Restricted Stock is cancelled or otherwise terminated, the Participant shall be obliged to transfer all of his unvested Shares of Restricted Stock to the Company promptly and for no consideration.

5.5

Upon the exercise or settlement of vested RSUs, the Company shall be obliged to pay to the Participant concerned (or the beneficiary of such RSUs, as applicable) an amount equal to the number of Plan Shares underlying such RSUs multiplied by the FMV of one Share on the applicable Exercise Date. The Company may satisfy such payment obligation in cash, in assets, in the form of Shares valued at FMV, or a combination thereof, at the discretion of the Committee (unless otherwise set forth in the Award Agreement).

5.6

The Committee may determine that a Participant holding one or more RSUs is entitled to receive dividends and other distributions made by the Company on the Shares, as if such Participant held the Plan Shares underlying such RSUs. The Committee may impose restrictions with respect to such entitlement.

PERFORMANCE CRITERIA

Article 6

6.1

The Committee may condition the right of a Participant to exercise one or more of his Awards or the vesting of one or more of his Awards, and the timing thereof, upon the achievement or satisfaction of such Performance Criteria as may be determined by the Committee, within periods specified by the Committee.

6.2

If an Award is subject to Performance Criteria which must be achieved or satisfied within a period specified by the Committee for that purpose, such Award can only be exercised or settled at or after the end of that period.

6.3

Performance Criteria may be measured on an absolute or relative basis and may be established on a Company-wide basis or with respect to one or more business units, divisions, Subsidiaries and/or business segments. Relative performance may be measured against a group of peer companies determined by the Committee, financial market indices and/or other objective and quantifiable indices. Performance Criteria may relate to performance by the Company and/or by the Participant concerned.

6.4

If the Committee determines that a change in the business, operations, group structure or capital structure of the Company, or other events or circumstances, render certain Performance Criteria applicable to outstanding Awards unsuitable or inappropriate, the Committee may amend or waive such Performance Criteria, in whole or in part, as the Committee deems appropriate.

PLAN SHARES AVAILABLE FOR AWARDS

Article 7

7.1

Subject to Articles 4.10 and 7.2, the Plan Shares underlying Awards, irrespective of whether such Awards have been exercised or settled, may not represent more than the Aggregate Share Pool.

7.2

Plan Shares underlying Awards which expire, which are cancelled or otherwise terminated, or which are exercised or settled in cash or assets in lieu of Plan Shares, shall again be available under this Plan and shall not be counted towards the limit imposed by Article 7.1.

VESTING, EXERCISE AND SETTLEMENT

Article 8

8.1

Each Award Agreement shall contain the vesting schedule and, where relevant, delivery schedule (which may include deferred delivery later than the vesting dates) for the relevant Awards.

8.2

Only vested Awards may be exercised or settled in accordance with their terms. An Award can only be exercised (to the extent it is not settled automatically) by or on behalf of the Participant holding such Award. Notwithstanding anything to the contrary in this Plan, the exercise or settlement of a vested Award shall always be and remain suspended until a registration statement registering the issuance of the Plan Shares issuable pursuant thereto has been filed with the United States Securities and Exchange Commission and is effective.

8.3

An Award can only be exercised through the use of an electronic system or platform to be designated by the Committee (if and when such system or platform has been set up by the Company), or otherwise by delivering written notice to the Company in a form approved by the Committee.

8.4

Subject to Article 9.1, the Committee shall determine the Exercise Price, provided that the Exercise Price for an Award which can be exercised or settled in the form of Plan Shares shall not be less than the aggregate nominal value of such Plan Shares.

8.5

Upon the exercise of an Award, the applicable Exercise Price must immediately be paid in cash, wire transfer of immediately available funds or by check payable to the order of the Company, provided that the Committee, subject to applicable law, may allow, including by providing for such treatment in an Award Agreement, such Exercise Price to be satisfied on a cashless or net settlement basis, applying any of the following methods (or a combination thereof):

by means of an immediate sale by or on behalf of the relevant Participant of part of the Plan Shares underlying the Award being exercised, with sale proceeds equal to the Exercise Price being remitted to the Company and any remaining net sale proceeds (less applicable costs, if any) being paid to such Participant;

by means of the relevant Participant forfeiting his entitlement to receive part of the Plan Shares underlying the Award being exercised at FMV on the Exercise Date and charging the aggregate nominal value of the remaining Plan Shares underlying such Award against the Company’s reserves;

by means of the relevant Participant surrendering his entitlement to receive part of the Plan Shares underlying the Award being exercised at FMV on the Exercise Date, against the Company becoming due an equivalent amount to such Participant and setting off that obligation against the Company’s receivable with respect to payment of the applicable Exercise Price; or

by means of the relevant Participant surrendering and transferring Shares to the Company (which may include Plan Shares underlying the Award being exercised) at FMV on the Exercise Date.

8.6

When an Award is exercised or settled in the form of Plan Shares, the Company shall, at the discretion of the Committee, subject to applicable law and the Company’s insider trading policy:

issue new Plan Shares to the relevant Participant; or

transfer existing Plan Shares held by the Company to the relevant Participant,

provided, in each case, that Plan Shares may be delivered in the form of book-entry securities representing those Plan Shares (or beneficial ownership of those Plan Shares entitling the holder to exercise or direct the exercise of voting rights attached thereto) credited to the securities account designated by the relevant Participant. Furthermore, Plan Shares may be delivered as described in the previous sentence to a Person designated by the relevant Participant, with the prior approval of the Committee, as beneficiary of his Award.

8.7

If an Award is exercised or settled in the form of Plan Shares and such Award does not relate to a whole number of Plan Shares, the number of Plan Shares underlying such Award shall be rounded down to the nearest integer.

PRICING RESTRICTIONS FOR OPTIONS AND SARS

Article 9

9.1

The Exercise Price for an Option or SAR shall not be less than the higher of:

the FMV of a Plan Share on the applicable Grant Date and, in case of a SAR being granted in connection with an Option, on the Grant Date of such Option; or

the nominal value of a Plan Share.

9.2

Except as provided in Article 4.10, the Committee may not, without prior approval of the General Meeting, seek to effect any re-pricing of any outstanding “underwater” Option or SAR by:

amending or modifying the terms of such Award to lower the Exercise Price;

cancelling such Award and granting in exchange either of (i) replacement Options or SARs having a lower Exercise Price, or (ii) Restricted Stock, RSUs or Other Awards; or

cancelling or repurchasing such Award for cash, assets or other securities.

9.3

Options and SARs will be considered to be “underwater” within the meaning of Article 9.2 at any time when the FMV of the Plan Shares underlying such Awards is less than the applicable Exercise Price.

U.S. PARTICIPANTS

Article 10

10.1

With respect to any Award subject to Section 409A IRC and Section 457A IRC, this Plan and the applicable Award Agreement are intended to comply with the requirements of Section 409A IRC and Section 457A IRC, the provisions of this Plan and such Award Agreement shall be interpreted in a manner that satisfies the requirements of Section 409A IRC and Section 457A IRC, and this Plan shall be operated accordingly. If any provision of this Plan or any term or condition of any Award subject to Section 409A IRC and Section 457A IRC would otherwise frustrate or conflict with this intent, the provision, term or condition will be interpreted and deemed amended so as to avoid this conflict.

10.2

Notwithstanding any provision of this Plan to the contrary or any Award Agreement, a termination of employment shall not deemed to have occurred for purposes of any provision of an Award that is subject to Section 409A IRC providing for payment upon or as a result of a termination of a Participant’s employment unless such termination is also a “separation from service” and, for purposes of any such provision of such Award, references to a “termination”, “termination of employment” or like terms shall mean “separation from service”.

10.3

If all or part of any payments made, or other benefits conferred, under any Award subject to Section 409A IRC constitutes deferred compensation for purposes of Section 409A IRC as a result of a “separation from service” of the relevant Participant (other than due to his death) within the meaning of Section 409A IRC while such Participant is a “specified employee” under Section 409A IRC, then such payment or benefit shall not be made or conferred until six months and one business day have elapsed after the date of such “separation from service”, except as permitted under Section 409A IRC.

10.4

If an Award includes a “series of installment payments” within the meaning of Section 1.409A-2(b)(2)(iii) of the United States Treasury Regulations, the right of the relevant Participant to such series of instalment payments shall be treated as a right to a series of separate payments and not as a right to a single payment, and if such an Award includes “dividend equivalents” within the meaning of Section 1.409A-3(e) of the United States Treasury Regulations, the right of the relevant Participant to such dividend equivalents shall be treated separately from the right to other amounts or other benefits under such Award.

10.5

For any Award subject to Section 409A IRC or Section 457A IRC that provides for accelerated distribution on a Change of Control of amounts that constitute “deferred compensation” as defined in Section 409A IRC and Section 457A IRC, if the event that constitutes such Change of Control does not also constitute a change in the ownership or effective control of the Company, or in the ownership of a substantial portion of the Company’s assets (in either case, as defined in Section 409A IRC), such amount shall not be distributed on such Change of Control but instead shall vest as of the date of such Change of Control and shall be paid on the scheduled payment date specified in the applicable Award Agreement, except to the extent that earlier distribution would not result in the relevant Participant incurring any additional tax, penalty, interest or other expense under Section 409A IRC and Section 457A IRC.

10.6

Notwithstanding the foregoing in this Article 10, the tax treatment of the benefits provided under this Plan or any Award Agreement is not warranted or guaranteed, and in no event shall the Company be liable for all or any portion of any taxes, penalties, interest or other expenses that may be incurred by a U.S. Participant on account of non-compliance with Section 409A IRC and Section 457A IRC.

10.7

Notwithstanding any provision of this Plan to the contrary or any Award Agreement, in the event the Committee determines that any Award may be subject to Section 409A IRC or Section 457A IRC, the Committee may adopt such amendments to this Plan and the applicable Award Agreement or adopt other policies and procedures (including amendments, policies and procedures with retroactive effect), or take any other actions, that the Committee determined are necessary or appropriate to:

exempt the Award from Section 409A IRC or Section 457A IRC and/or preserve the intended tax treatment of the benefits provided with respect to the Award; or

comply with the requirements of Section 409A IRC or Section 457A IRC and thereby avoid the application of any adverse tax consequences under such Sections.

LEAVER

Article 11

11.1

If a Participant becomes a Good Leaver, unless otherwise determined by the Committee or set forth in an Award Agreement:

all vested Awards that have not yet been exercised or settled must be exercised or settled in accordance with their terms within a period specified by the Committee and, if such Awards are not exercised or (through no fault of the Participant concerned) not settled within such period, they shall be cancelled automatically without compensation for the loss of such Awards; and

all unvested Awards of such Participant shall be cancelled automatically without compensation for the loss of such Awards, unless the Committee decides otherwise.

11.2

If a Participant becomes a Bad Leaver, all vested Awards of such Participant which have not been exercised or settled, as well as all unvested Awards of such Participant, shall be cancelled automatically without compensation for the loss of such Awards.

CHANGE OF CONTROL

Article 12

12.1

If long-term incentive awards are granted in assumption of, or in substitution or exchange for, outstanding Awards in connection with a Change of Control and the Committee has determined that such awards are sufficiently equivalent to the outstanding Awards concerned, then such outstanding Awards shall be cancelled and terminated upon the replacement awards being granted to the Participants If, in connection with a Change of Control, outstanding Awards are not replaced by long-term incentive awards as described in Article 12.1, or are replaced by long-term incentive awards which the Committee does not consider to be sufficiently equivalent to such outstanding Awards, then such Awards shall immediately vest and, where relevant, settle in full, unless the Committee decides otherwise.

concerned.

12.2

12.3

For purposes of this Article 12, awards shall not be considered to be “sufficiently equivalent” to outstanding Awards, if the underlying securities are not widely held and publicly traded on a regulated national stock exchange.

LOCK-UP

Article 13

13.1

In connection with any registration of the Company’s securities under United States securities laws, to the extent requested by the Company or the underwriters managing any offering of the Company’s securities, and except as otherwise approved by the Committee or pursuant to any exceptions approved by such underwriters, a Participant may not Transfer any Shares acquired by a Participant pursuant to the issuance, vesting, exercise or settlement of any Award prior to such period following the effective date of such registration as designated by such underwriters, not to exceed 180 days following such registration.

13.2

The Company may impose stop-transfer instructions with respect to the Shares subject to the restriction stipulated by Article 13.1 until the end of the lock-up period referred to in that provision.

TAX

Article 14

14.1

Any and all tax liability (e.g., any wage tax or income tax) and employee social security premiums due in connection with or resulting from the granting, vesting, exercise or settlement of an Award (or the implementation of the Plan) or any payment or transfer under an Award (or under the Plan generally) shall be for the account of the relevant Participant.

14.2

The Company or any Subsidiary may, and each Participant shall permit the Company or any Subsidiary to, withhold from any Award granted or any payment due or transfer made under any Award (or under the Plan generally) or from any compensation or other amount owing to a Participant the amount (in cash, Shares, other Awards, other property, net settlement or any combination thereof) of applicable income taxes or (wage) withholding taxes due in respect of an Award, the grant of an Award, its exercise or settlement (or the implementation of the Plan), or any payment or transfer under such Award (or under the Plan generally) and to take such other action, including providing for (elective) payment of such amounts in cash or Shares by the Participant, as may be necessary in the option of the Company to satisfy all obligations for the payment of such taxes. In addition, the Company may cause the sale by or on behalf of the relevant Participant of part of the Plan Shares underlying any Award being exercised or settled, with sale proceeds equal to the applicable wage or withholding taxes being remitted to the Company and any remaining net sale proceeds (less applicable costs, if any) being paid to such Participant.

14.3

This Plan is governed by the tax laws and social security legislation and regulations prevailing at the date a certain taxable event occurs.

If any tax and/or employee social security legislation or regulations are amended and any tax or employee social security levies become payable as a result of such legislative amendment, the costs and the risk related thereto shall be born solely by the relevant Participant.

14.4

Notwithstanding the provisions of Article 14.2, where, in relation to an Award granted under this Plan, the Company or any Subsidiary (as the case may be) is liable, or is in accordance with the current practice believed by the Committee to be liable, to account for any tax or social security authority for any sum in respect of any tax or social security liability of the Participant, the Award may not be exercised unless the relevant Participant has paid to the Company or the relevant Subsidiary (as the case may be) an amount sufficient to discharge the liability).

14.5

If, and to the extent, the Company or any Subsidiary (as the case may be) is not reimbursed, by means of the provisions of Article 14.2 or 14.4, for any wage tax or income tax, employee’s social security contributions liability or any other liabilities for which the Company or a Subsidiary (as the case may be) has an obligation to withhold and account, the Participant shall indemnify and hold harmless the Company or any Subsidiary (as the case may be) for any such taxes paid by the Company or any Subsidiary (as the case may be).

14.6

For the avoidance of doubt, the provisions of this Article 14 shall apply to a Participant’s liabilities that may arise on a taxable event in any jurisdiction.

DATA PROTECTION

Article 15

15.1

The Company may process personal data relating to the Participants in connection with the administration and operation of this Plan. The personal data of the Participants which may be processed in this respect may include a copy of an identification document, contact details and bank and securities account numbers. Each Participant’s personal data shall be stored by the Company for such time period as is necessary to administer such Participant’s participation in the Plan or as otherwise permitted under applicable law.

15.2

Each Participant’s personal data shall be handled by the Company in accordance with applicable law, including the General Data Protection Regulation (GDPR) and the rules and regulations promulgated pursuant thereto. Participants have the right to lodge complaints with an applicable supervisory authority regarding the Company’s processing of personal data pursuant to this Plan.

15.3

The Company shall implement technical, physical and organisational measures designed to protect personal data processed pursuant to Article 15.1. Personnel or third parties that have access to such personal data shall be bound by confidentiality obligations.

15.4

The Company shall abide by any statutory rights the Participants may have regarding their respective personal data processed pursuant to Article 15.1, which may include the right to access, rectification, erasure, restriction of processing, objection to processing and portability of such personal data.

15.5

In connection with the administration and operation of this Plan, the Company may transfer personal data processed pursuant to Article 15.1 to one or more third parties, provided that there is a legitimate interest in doing so. Where such third parties are located outside the European Economic Area in countries that are not considered to provide for an adequate level of data protection, the Company shall ensure that sufficient data protection safeguards are put in place, failing which explicit consent for such transfer shall be obtained from the Participant(s) concerned.

15.6

The Company may establish one or more privacy policies providing further information on data protection and applying to the processing of personal data of the Participants by the Company in connection with the administration and operation of this Plan.

AMENDMENTS, TERM AND TERMINATION

Article 16

16.1

Except to the extent prohibited by applicable law and unless otherwise expressly provided in an Award Agreement, the Board, solely with the approval of a majority of the Independent Directors (as such term is defined in Nasdaq Listing Rule 5605(a)(2)) then serving on the Board, may amend, supplement, suspend or terminate this Plan (or any portion thereof) pursuant to a resolution to that effect, provided that no such amendment, supplement, suspension or termination shall take effect without:

approval of the General Meeting, if such approval is required by applicable law or stock exchange rules; and/or

the consent of the affected Participant(s), if such action would materially and adversely affect the rights of such Participant(s) under any outstanding Award, except to the extent that any such amendment, supplement or termination is made to cause this Plan to comply with applicable law, stock exchange rules, accounting principles or tax rules and regulations.

16.2

Notwithstanding anything to the contrary in the Plan, the Committee may amend the Plan and/or any Award Agreement in such manner as may be necessary or desirable to enable the Plan and/or such Award Agreement to achieve its stated purposes in any jurisdiction in a tax-efficient manner and in compliance with local laws, rules and regulations to recognise differences in local law, tax policy or custom. The Committee also may impose conditions on the exercise or vesting of Awards in order to minimise the Company’s obligation with respect to tax equalisation for Participants on assignments outside their home country and/or to enable the Company to meet its obligations with respect to the withholding of taxes and social security contributions.

16.3

The Plan shall become effective on the Effective Date. To the extent the Company is or becomes subject to the requirements of Nasdaq Listing Rule 5635(c) (or any successor thereto), no Awards may be granted after the tenth anniversary of the Effective Date.

GOVERNING LAW AND JURISDICTION

Article 17

This Plan shall be governed by and shall be construed in accordance with the laws of the Netherlands. Subject to Article 3.1 paragraph g., any dispute arising in connection with these rules shall be submitted to the exclusive jurisdiction of the competent court in Amsterdam, the Netherlands.

Last Updated: September 23, 2025

Annex A - Addendum for U.S. Participants

Definitions

1.1

Except as otherwise defined below, capitalised terms used herein have the meanings ascribed thereto in the inducement plan (the “Plan”) of NewAmsterdam Pharma Company N.V. (the “Company”).

1.2

In this addendum (the “U.S. Addendum”), the following words will have the meaning as defined below:

“Code” means the U.S. Internal Revenue Code of 1986, as amended, and the regulations and guidance issued thereunder.

“Disability” means the inability of a U.S. Participant to engage in any substantial gainful activity by reason of any medically determinable physical or mental impairment that can be expected to result in death or that has lasted or can be expected to last for a continuous period of not less than twelve (12) months as provided in Sections 22(e)(3) and 409A(a)(2)(c)(i) of the Code, and will be determined by the Board on the basis of such medical evidence as the Board deems warranted under the circumstances.

“Fair Market Value” means as of any date, the value of the Shares determined by the Board in compliance with Section 409A of the Code.

“Incentive Stock Option” or “ISO” means an Option that is intended to be, and qualifies as, an incentive stock option within the meaning of Section 422 of the Code.

“Nonstatutory Stock Option” or “NSO” means an Option that does not qualify as an Incentive Stock Option.

“Subsidiary” means a corporation, whether now or hereafter existing, in an unbroken chain of corporations beginning with the Company, if each corporation other than the Company owns shares possessing 50% or more of the total combined voting power of all classes of shares in one of the other corporations in such chain, as provided in the definition of a “subsidiary corporation” contained in Section 424(f) of the Code.

“U.S.” means the United States of America.

Purpose and Applicability.

2.1

This U.S. Addendum applies to U.S. Participants. The purpose of the U.S. Addendum is to facilitate compliance with U.S. tax, securities and other applicable laws, and to facilitate the Company to issue Awards to eligible U.S. Participants.

2.2

Except as otherwise provided by the U.S. Addendum, all grants of Awards made to U.S. Participants will be governed by the terms of the Plan, when read together with the U.S. Addendum. In any case of an irreconcilable contradiction (as determined by the Board) between the provisions of the U.S. Addendum and the Plan, the provisions of the U.S. Addendum will govern.

Additional Terms and Conditions Applicable to All Options Granted to U.S. Participants.

3.1

Maximum Term of Options. No Option will be exercisable after the expiration of ten (10) years from the Grant Date, or such shorter period specified in the applicable Award Agreement.

3.2

Exercise Price. No Option shall have an Exercise Price that is less than Fair Market Value on the Grant Date.

3.3

Transferability of Options. A U.S. Participant may only transfer an Option if permitted by the Board. The Board may only permit transfer of the Option in a manner that is permitted by the Plan and is not prohibited by applicable U.S. tax and securities laws. The Board, in its sole discretion, may impose such limitations on the transferability of Options as the Board will determine. In the absence of such a determination by the Board to the contrary, the following restrictions on the transferability of Options will apply:

3.4

Restriction on Transfer. An Option will not be transferable except by will or by the laws of descent and distribution (or pursuant to paragraphs a. and b. below), and will be exercisable during the lifetime of the U.S. Participant only by the U.S. Participant. An Option may not be transferred for consideration.

3.5

Domestic Relations Orders. Subject to the approval of the Board, an Option may be transferred pursuant to the terms of a domestic relations order, official marital settlement agreement or other divorce or separation instrument.

Beneficiary Designation. Subject to the approval of the Board, a U.S. Participant may, by delivering written notice to the Company, in a form approved by the Company (or the designated broker), designate a third party who, on the death of the U.S. Participant, will thereafter be entitled to exercise the Option and receive the Plan Shares or other consideration resulting from such exercise. In the absence of such a designation, upon the death of the U.S. Participant, the executor or administrator of the U.S. Participant’s estate will be entitled to exercise the Option and receive the Plan Shares or other consideration resulting from such exercise. However, the Company may prohibit designation of a beneficiary at any time, including due to any conclusion by the Company that such designation would be inconsistent with the provisions of applicable laws.

3.6

Eligible Recipients of Awards. Awards may not be granted to any person whose employment with the Company has not yet commenced.

Tax Matters

4.1

Tax Withholding Requirement. Prior to the delivery of any Plan Shares pursuant to the exercise of an Option or pursuant to any other Award, the Company will have the power and the right to deduct or withhold, or require a U.S. Participant to remit to the Company, an amount sufficient to satisfy U.S. federal, state, local, non-U.S. or other taxes required to be withheld with respect to such Award.

4.2

Withholding Arrangements. The Company may, in its sole discretion, satisfy any U.S. federal, state, local, foreign or other tax withholding obligation relating to an Award by any of the following means or by a combination of such means: (i) causing the U.S. Participant to tender a cash payment; (ii) withholding Shares issued or otherwise issuable to the U.S. Participant in connection with the Award; or (iii) withholding payment from any amounts otherwise payable to the U.S. Participant.

4.3

No Obligation to Notify or Minimize Taxes. The Company will have no duty or obligation to the U.S. Participant to advise such holder as to the time or manner of exercising the Option. Furthermore, the Company will have no duty or obligation to warn or otherwise advise such holder of a pending termination or expiration of an Option or a possible period in which the Option may not be exercised. The Company has no duty or obligation to minimize the tax consequences of an Award to the U.S. Participant.

Term, Amendment and Termination of the U.S. Addendum.

5.1

The Board, solely with the approval of a majority of the Independent Directors (as such term is defined in Nasdaq Listing Rule 5605(a)(2)) then serving on the Board, may amend, suspend or terminate this U.S. Addendum at any time. Unless terminated sooner by the Board, the U.S. Addendum will terminate automatically upon the earliest of (i) 10 years after adoption of the U.S. Addendum by the Board, or (ii) the termination of the Plan. No Options may be granted under the U.S. Addendum while either the Plan or the U.S. Addendum is suspended or after the Plan or the U.S. Addendum is terminated.

5.2

If this U.S. Addendum is terminated, the provisions of this U.S. Addendum and any administrative guidelines, and other rules adopted by the Board and in force at the time of suspension or termination of this U.S. Addendum, will continue to apply to any outstanding Award as long as an Award issued pursuant to the U.S. Addendum remain outstanding.

5.3

No amendment, suspension or termination of the U.S. Addendum may materially and adversely affect any Awards granted previously to any U.S. Participant without the consent of the U.S. Participant.

Annex A Last Updated: April 25, 2024

EX-31.1 4 nams-ex31_1.htm EX-31.1 EX-31.1

Exhibit 31.1

CERTIFICATION 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

I, Michael Davidson, M.D., certify that:

I have reviewed this quarterly report on Form 10-Q of NewAmsterdam Pharma Company N.V.;

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c)

Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d)

Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

(a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.


Date: November 5, 2025	By:	/s/ Michael Davidson
		Michael Davidson, M.D.
		Chief Executive Officer and Director

EX-31.2 5 nams-ex31_2.htm EX-31.2 EX-31.2

Exhibit 31.2

CERTIFICATION 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

I, Ian Somaiya, certify that:

I have reviewed this quarterly report on Form 10-Q of NewAmsterdam Pharma Company N.V.;

(a)

(b)

(c)

(d)

(a)

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.


Date: November 5, 2025	By:	/s/ Ian Somaiya
		Ian Somaiya
		Chief Financial Officer

EX-32.1 6 nams-ex32_1.htm EX-32.1 EX-32.1

Exhibit 32.1

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of NewAmsterdam Pharma Company N.V. (the “Company”) on Form 10-Q for the period ended September 30, 2025 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:

(1)

The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2)

The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.


Date: November 5, 2025	By:	/s/ Michael Davidson
		Michael Davidson, M.D.
		Chief Executive Officer and Director

EX-32.2 7 nams-ex32_2.htm EX-32.2 EX-32.2

Exhibit 32.2

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

(1)

The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2)

The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.


Date: November 5, 2025	By:	/s/ Ian Somaiya
		Ian Somaiya
		Chief Financial Officer