NewAmsterdam Pharma Co NV
For the period ended Mar 31, 2024. Filed May 8, 2024.
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Mar 31, 2024 · Filed May 8, 2024
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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.”
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, 2023, included in our Annual Report on Form 10-K (the "Annual Report"), filed with the SEC on February 28, 2024. 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 U.S. Securities and Exchange Commission (“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, 2023 included herein has been derived from the audited financial statements at that date but does not include all of the information required by 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 months ended March 31, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024 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.
Prior to 2023, the Company prepared its financial statements in accordance with the International Financial Reporting Standards as issued by the International Accounting Standard Board (“IFRS”) as permitted in the United States based on the Company’s qualification as a foreign private issuer under the rules and regulations of the SEC. In connection with the loss of the Company’s status as a foreign private issuer effective on January 1, 2024, the Company, as a domestic filer, prepared these financial statements in accordance with U.S. GAAP. The transition to U.S. GAAP was made retrospectively for all periods from the Company’s inception.
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.
Net Loss Per Share
Basic net loss per share is calculated by dividing the net loss by the weighted-average number of Ordinary Shares outstanding during the period. For the purposes of calculating the weighted-average number of Ordinary Shares outstanding, the Ordinary Shares underlying the Pre-Funded Warrants issued in the Offering (as defined in Note 7 below) are included. Diluted net loss per share is the same as basic net loss per share, since the effects of potentially dilutive securities are antidilutive given the net loss for each period presented.
Note 3. Revenue
Revenue consisted of the following:
| Three months ended March 31, | ||
|---|---|---|
| (In thousands of USD) | 2024 | 2023 |
| License revenue attributed from license performance obligation | — | 5,385 |
| License revenue attributed from R&D performance obligation | 1,401 | 3,244 |
| Total revenue | 1,401 | 8,629 |
All revenue recognized from the R&D performance obligation was included within deferred revenue on the consolidated balance sheet as of the beginning of the applicable reporting period.
Note 4. Fair Value Measurements
As of March 31, 2024 and December 31, 2023, the Company’s financial liabilities recognized at fair value on a recurring basis consisted of the following:
| (In thousands of USD) | Level 1 | Level 2 | Level 3 | Total |
|---|---|---|---|---|
| Derivative warrant liability (Public Warrants) | 31,217 | — | — | 31,217 |
| Derivative warrant liability (Private Placement Warrants) | — | 1,844 | — | 1,844 |
| Derivative earnout liability | — | — | 16,490 | 16,490 |
| Total financial liabilities | 31,217 | 1,844 | 16,490 | 49,551 |
| (In thousands of USD) | Level 1 | Level 2 | Level 3 | Total |
|---|---|---|---|---|
| Derivative warrant liability (Public Warrants) | 12,051 | — | — | 12,051 |
| Derivative warrant liability (Private Placement Warrants) | — | 523 | — | 523 |
| Derivative earnout liability | — | — | 7,788 | 7,788 |
| Total financial liabilities | 12,051 | 523 | 7,788 | 20,362 |
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:
| March 31, 2024 | December 31, 2023 | |
|---|---|---|
| Ordinary Share value (USD) | $23.65 | $11.17 |
| Probability of milestone completion | 40% | 40% |
| Dividend yield | 0% | 0% |
| Strike price (USD) | 0.00 | 0.00 |
As management's judgment of the probability of milestone completion remained constant during the period, the change in fair value resulted from the Company’s price per share between valuation dates.
The following table presents a reconciliation of the derivative earnout liability measured on a recurring basis using Level 3 inputs as of March 31, 2024:
| Balance on December 31, 2023 | 7,788 |
|---|---|
| Change in fair value recognized through profit and loss | 8,702 |
| Balance on March 31, 2024 | 16,490 |
All changes in fair value recognized in the statement of operations are unrealized. There wereno sales, purchases, settlements or transfers into or out of Level 3 of the fair value hierarchy related to the derivative earnout liability during the period ended March 31, 2024.
Note 5. Prepayments and Other Receivables
Prepayments and other receivables consisted of the following:
| (In thousands of USD) | March 31,2024 | December 31,2023 |
|---|---|---|
| Prepaid research and development costs | 420 | 2,337 |
| Other prepaid expenses | 2,122 | 2,123 |
| Value added tax receivable | 148 | 1,006 |
| Other receivables | 3,985 | 875 |
| Total prepayments and other receivables | 6,675 | 6,341 |
Note 6. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following:
| (in thousands of USD) | March 31,2024 | December 31,2023 |
|---|---|---|
| Accrued research and development materials and services | 7,190 | 5,945 |
| Accrued compensation and benefits | 1,105 | 3,384 |
| Accrued professional fees and other | 1,675 | 2,069 |
| Total accrued expenses and other current liabilities | 9,970 | 11,398 |
Note 7. Shareholders’ Equity
Follow-on Offering
On February 16, 2024,the Company completed an underwritten public offering (the “Offering”)of 5,871,909 Ordinary Shares at a public offering price of $19.00 per Ordinary Share and, in lieu of Ordinary Shares to certain investors, pre-funded warrants (the “Pre-Funded Warrants”)to purchase 4,736,841 Ordinary Shares at a public offering price of $18.9999 per Pre-Funded Warrant, which represents the per share public offering price for the Ordinary Shares, less the $0.0001 per share exercise price for each such Pre-Funded Warrant. Of the 5,871,909 Ordinary Shares issued and sold in the offering,1,383,750 Ordinary Shares were issued and sold pursuant to the exercise of the underwriters’ option to purchase additional Ordinary Shares at the public offering price per share. The Ordinary Shares and Pre-Funded Warrants were issued and sold pursuant to an underwriting agreement, among the Company and Jefferies LLC, Leerink Partners LLC, Piper Sandler & Co. and RBC Capital Markets, LLC, as representatives of the several underwriters listed on Schedule A thereto. The net proceeds to the Company from the Offering were $190.0 million after deducting underwriting discounts and commissions and offering expenses payable by the Company.
Note 8. Share-Based Compensation
The Company has three Share-based payment plans and one restricted share award in place as at March 31, 2024:
The Company’s Long-Term Incentive Plan (the “Plan”);
The Company’s Supplementary Long-Term Incentive Plan (the “Supplementary Plan”);
The Company’s Rollover Option Plan (the “Rollover Plan,” together with the Plan and the Supplementary Plan, the “Plans”); and
Chief Executive Officer Restricted Share Award.
Long Term Incentive Plans
The Plans are equity-settled, and the Company may grant various forms of equity awards, including the granting of options to purchase Ordinary Shares (“Company Options”) and restricted stock units (“RSUs”), pursuant to the Plans. In total, as of March 31, 2024 a maximum of 20,549,356 Ordinary Shares may be reserved for issuance pursuant to the Plans. The number of Ordinary Shares reserved for grant under the Plan will increase annually on January 1 of each calendar year by 5% of the then issued and outstanding Ordinary Shares or such lower number as may be determined by the 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 afour-year vesting period with 25% vesting after one year and the remaining 75% vesting in equal monthly installments over the next following three years.
The changes for thethree months ended March 31, 2024 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, 2023 | 15,783,509 | $7.98 | ||
| Granted | 4,096,148 | $12.81 | ||
| Exercised | (546,403) | $1.27 | ||
| Outstanding as at March 31, 2024 | 19,333,254 | $9.18 | 8.8 | 279,666 |
| Options exercisable as of March 31, 2024 | 6,134,169 | $5.64 | 8.0 | 110,454 |
The weighted average grant date fair value of Company Options, estimated as of the grant date using the Black-Scholes option pricing model, was $5.90, and $4.82 per option for options granted during the three months ended March 31, 2024 and 2023, respectively. The total intrinsic value (the amount by which the fair market value exceeded the exercise price) of Company Options exercised during the three months ended March 31, 2024 was $8.0 million. No Company Options were exercised in the three months ended March 31, 2023. Weighted average assumptions used to apply this pricing model were as follows:
| Three months ended March 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Expected life (years) | 6.1 | 6.1 |
| Risk-free rate | 3.9% | 4.0% |
| Volatility | 41.2% | 38.5% |
| Dividend yield | 0.0% | 0.0% |
Expected Term
The Company’s expected term represents the period that the Company’s stock-based awards are expected to be outstanding and is determined using the simplified method (based on the mid-point between the vesting date and the end of the contractual term). The Company utilizes this method due to lack of historical exercise data and the plain-vanilla nature of the Company’s stock-based awards.
Expected Volatility
Since the Company was privately held through November 2022, it alone does not have 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 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 life of the stock-based awards. The historical volatility data was computed using the daily closing prices for the selected companies’ shares during the equivalent period of the calculated expected term of the stock-based awards.
Risk-Free Interest Rate
The risk-free interest rate is based upon the U.S. Treasury yield curve in effect at the time of grant, with a term that approximates the expected life of the Company Option.
Expected Dividend
The expected dividend rate is zero as the Company currently has no history or expectation of declaring dividends on its Ordinary Shares.
Share-based compensation is classified in the consolidated statement of operations and comprehensive loss as follows:
| Three months ended March 31, | ||
|---|---|---|
| (in thousands of USD) | 2024 | 2023 |
| Research and development expenses | 3,479 | 4,489 |
| Selling, general and administrative expenses | 4,439 | 3,127 |
| Total | 7,918 | 7,616 |
As of March 31, 2024, there was $41.5 million of unrecognized compensation cost related to Company Options that have not yet vested. These costs are expected to be recognized over a weighted average period of 3.3 years until fully vested.
Restricted Stock Units
As at March 31, 2024 and December 31, 2023, 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. These Earnout Shares will be delivered in the form of awards of RSUs granted pursuant to the Plan to such Participating Optionholders who are at the time of achievement of such milestone still providing services to the Company.
The development milestone consists of the achievement and public announcement of positive Phase 3 data for each of the Company’s BROADWAY clinical trial and BROOKLYN clinical trial at any time during the period beginning on November 22, 2022 and ending on the date that is five years after such date.
There is no impact on these financial statements with respect to these RSUs due to the uncertainty of achieving the clinical development milestone.
Chief Executive Officer Restricted Share Award
In July 2021, the Company's chief executive officer, Michael Davidson, M.D., paid the fair market value of the underlying Ordinary Shares (in aggregate $838,806) when he made an investment in restricted shares issued through Depositary Receipts. The total fair value of these equity-settled share-based payment awards amounts to nil and there will be no expenses recognized in the income statement. This award had afour year vesting period with 25% vesting on August 1, 2021 and the remaining 75% vesting in equal monthly installments over the following three years.
In connection with the award arrangement, if Dr. Davidson leaves the Company, all unvested Ordinary Shares will be cancelled against payment by the Company to him of the lower of the (i) the purchase price paid and (ii) the fair market value of such Ordinary Shares at the time of forfeiture. In order to reflect the consideration paid and the possibility that the Ordinary Shares would be repurchased if Dr. Davidson becomes a “Good Leaver” (as such term is defined in the award agreement) during the vesting period, the Company has recognized the consideration as a financial liability until the award has fully vested, at which time it will be reclassified to equity provided that Dr. Davidson remains with the Company. This liability is measured at the lower of (i) the purchase price paid and (ii) the fair market value of the Ordinary Shares at the end of the reporting period. The liability for unvested Ordinary Shares as at March 31, 2024 and December 31, 2023 amounted to $0.1 million and $0.1 million, respectively.
For thethree months ended March 31, 2024, the movements in the number of Ordinary Shares outstanding are as follows:
| Outstanding as at December 31, 2023 | 608,779 |
|---|---|
| Granted/purchased during the period | — |
| Outstanding as at March 31, 2024 | 608,779 |
As of March 31, 2024 and December 31, 2023, a total of 558,048 and 519,999 Ordinary Shares had vested, respectively.
Note 9. 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 issued in the Offering are included.
Basic and diluted net loss per Ordinary Share was calculated as follows:
| Three months ended March 31, | ||
|---|---|---|
| (In thousands of USD, except share and per share amounts) | 2024 | 2023 |
| Net loss | (93,767) | (42,018) |
| Weighted average Ordinary Shares outstanding, basic and diluted | 88,380,230 | 81,634,428 |
| Net loss per Ordinary Share, basic and diluted | (1.06) | (0.51) |
The following potentially dilutive securities have been excluded from the computation of diluted weighted-average Ordinary Shares outstanding as they would be anti-dilutive:
| Three months ended March 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Stock options | 19,333,254 | 15,347,590 |
| Outstanding warrants | 2,994,673 | 4,558,930 |
| Total | 22,327,927 | 19,906,520 |
Note 10. Commitments and Contingencies
Commitments
The Company has entered into a variety of agreements financial commitments in the normal course of business with contract research organizations, contract manufacturing organizations, and other third parties for preclinical and clinical development and manufacturing services. The terms generally provide us with the option to cancel, reschedule and adjust our requirements based on our business needs, prior to the delivery of goods or performance of services. Payments due upon cancellation generally consist only of payments for services provided or expenses incurred, including non-cancellable obligations of our service providers, up to the date of cancellation. However, some of our service providers also charge cancellation fees upon cancellation. The amount and timing of such payments are not known, but at March 31, 2024 they are estimated to be a maximum of $19.2 million.
According to the terms of the Menarini License the Company will be responsible for development and commercialization costs related to Licensed Products other than those in the Menarini Territory. In addition, under specified conditions of the agreement, 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 11. Related Parties
In the ordinary course of business, the Company may enter into transactions with entities that are associated with a party that meets the criteria of a related party of the Company. These transactions are reviewed quarterly and to date have not been material to the Company’s consolidated financial statements.
Note 12. Subsequent Events
None.
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