Full Press Release Details
NewAmsterdam Pharma Reports Full Year 2023 Financial Results and Provides Corporate Update
On-track to report topline data from Phase 3 BROOKLYN trial in HeFH in 3Q 2024 and Phase 3
BROADWAY trial in ASCVD in 4Q 2024
Plan to initiate TANDEM, pivotal Phase 3 trial evaluating obicetrapib and
ezetimibe fixed-dose combination, in 1Q 2024; topline data expected in 1Q 2025
Expect to complete enrollment in Phase
3 PREVAIL CVOT in 1Q 2024; topline data expected in 2026
Completed $202 million upsized public offering,
expanding shareholder base with strong participation from new investors, existing shareholders, and insiders; proforma cash of $500 million
Naarden, the Netherlands and Miami, USA; February 28, 2024 NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or
NewAmsterdam or the Company ), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated low-density lipoprotein cholesterol ( LDL-C ), for whom existing therapies are not sufficiently effective or well-tolerated, today announced financial results for
the fourth quarter and full year ended December 31, 2023 and provided a corporate update.
2023 was a year of remarkable progress for
NewAmsterdam, marked by consistent clinical execution and substantial corporate development. We reported multiple encouraging datasets and expanded our team with key hires, underscoring our commitment to revolutionizing patient outcomes, building a
fully integrated company with the potential to deliver obicetrapib globally, if approved, and continue creating significant value for our shareholders, said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. We enter 2024
in a position of strength, with multiple upcoming milestones and a healthy balance sheet to support our operations. In the near-term, we look forward to topline results from BROOKLYN and BROADWAY in the third and fourth quarters of 2024,
respectively, which we expect will build on the promising datasets generated from our prior Phase 2 trials and support obicetrapib s ability to positively impact key lipid and lipoprotein measurements associated with risk for cardiovascular
Dr. Davidson continued, In addition, in the first quarter of this year, we anticipate completing enrollment in PREVAIL, our
cardiovascular outcomes trial, and launching TANDEM, our fourth pivotal Phase 3 trial, which will evaluate a fixed-dose combination of obicetrapib and ezetimibe. As we advance our clinical program, we continue to invest strategically in our
commercial organization to lay the foundation for obicetrapib s successful global launch, pending necessary regulatory approvals. We believe we are on the precipice of delivering a transformative solution to improve outcomes for over
30 million patients impacted by cardiovascular disease in the U.S., and we eagerly anticipate sharing further progress and achievements in the upcoming year.
2023 Highlights and Recent Progress
Development Updates:
NewAmsterdam is developing obicetrapib, an oral, low-dose and once-daily cholesteryl
ester transfer protein ( CETP ) inhibitor, as the preferred LDL-C lowering therapy to be used in patients at risk of CVD for whom existing therapies are not sufficiently effective or well-tolerated.
In 2023, NewAmsterdam reported positive, statistically significant and clinically meaningful data from two Phase 2 clinical trials of obicetrapib: the Phase 2 ROSE2 trial, which evaluated obicetrapib in combination with ezetimibe, and a Phase 2b
dose-finding trial, which evaluated obicetrapib in Japanese patients. In total, the Company has completed six Phase 1 or 2 clinical trials and tested obicetrapib in over 800 patients. Statistically significant
LDL-lowering was observed in each of the Company s completed Phase 2 clinical trials, combined with a side effect profile similar to placebo.
The Company is currently conducting three pivotal Phase 3 clinical trials of obicetrapib: BROOKLYN, BROADWAY
and PREVAIL. In addition, the Company plans to initiate a fourth Phase 3 trial, TANDEM, evaluating a fixed-dose combination ( FDC ) of obicetrapib and ezetimibe.
In 2023, NewAmsterdam reported positive initial data from a Phase 2a clinical trial evaluating obicetrapib in patients with early
Alzheimer s disease who carry at least one copy of the apolipoprotein E4 mutation. NewAmsterdam anticipates sharing the full results from this Phase 2a clinical trial in a forthcoming publication or in a presentation at a medical meeting.
Upcoming Potential Milestones
NewAmsterdam currently expects to achieve the following upcoming milestones:
Full Year 2023 Financial Results
Obicetrapib is a novel, oral, low-dose CETP inhibitor that NewAmsterdam is developing to overcome the
limitations of current LDL-lowering treatments. The Company believes that obicetrapib has the potential to be a once-daily oral CETP inhibitor for lowering LDL-C, if
approved. In the Company s Phase 2b ROSE trial, obicetrapib demonstrated a 51% lowering of LDL-C from baseline at a 10 mg dose level on top of high-intensity statins and, in the Company s Phase 2
ROSE2 trial, the combination of a 10 mg dose of obicetrapib and a 10 mg dose of ezetimibe demonstrated a 63% lowering of LDL-C from baseline. In each of the Company s Phase 2 trials, ROSE2, TULIP, ROSE,
and OCEAN, evaluating obicetrapib as monotherapy or combination therapy, the Company observed statistically significant LDL-lowering combined with a side effect profile similar to that of placebo, including no
increase in blood pressure or muscle related side effects. Obicetrapib has demonstrated strong tolerability in more than 800 patients with elevated lipid levels ( dyslipidemia ) in NewAmsterdam s clinical trials to date. The Company
is conducting two Phase 3 pivotal trials, BROADWAY and BROOKLYN, to evaluate obicetrapib as a monotherapy used as an adjunct to maximally tolerated lipid-lowering therapies to provide additional LDL-lowering
for high-risk cardiovascular disease ( CVD ) patients. The Company began enrolling patients in BROADWAY in January 2022 and in BROOKLYN in July 2022 and completed enrollment of BROOKLYN in April 2023 and BROADWAY in July 2023. The Company
also commenced the Phase 3 PREVAIL cardiovascular outcomes trial in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of major adverse cardiovascular events, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and non-elective coronary revascularization.
NewAmsterdam Pharma (Nasdaq: NAMS) 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. We seek to fill a significant unmet need for a safe,
well tolerated and convenient LDL-lowering therapy. In multiple phase 3 studies, NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP
inhibitor, alone or as a fixed-dose combination with ezetimibe, as preferred LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated.
Forward-Looking Statements
Certain statements included in this document that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the
United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as believe, may, will, estimate, continue,
anticipate, intend, expect, should, would, plan, predict, potential, seem, seek, future, outlook and
similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the consummation of the proposed Offering.
These statements are based on various assumptions, whether or not identified in this document, and on the current expectations of the Company s management and are not predictions of actual performance. These forward-looking statements are
provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or
impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and
foreign business, market, financial, political, and legal conditions; risks relating to the uncertainty of the projected financial information with respect to the Company; risks related to the approval of the Company s product candidate and the
timing of expected regulatory and business milestones; ability to negotiate definitive contractual arrangements with potential customers; the impact of competitive product candidates; ability to obtain sufficient supply of materials; global economic
and political conditions, including the Russia-Ukraine and Israel-Hamas conflicts; the effects of competition on the Company s future business; and those factors described in the Company s public filings with the SEC. Additional risks
related to the Company s business include, but are not limited to: uncertainty regarding outcomes of the Company s ongoing clinical trials, particularly as they relate to regulatory review and potential approval for its product candidate;
risks associated with the Company s efforts to commercialize a product candidate; the Company s ability to negotiate and enter into definitive agreements on favorable terms, if at all; the impact of competing product candidates on the
Company s business; intellectual property related claims; the Company s ability to attract and retain qualified personnel; ability to continue to source the raw materials for its product candidate. If any of these risks materialize or the
Company s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that the Company does not presently know or that the Company currently
believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect the Company s expectations, plans, or forecasts of future events and
views as of the date of this document and are qualified in their entirety by reference to the cautionary statements herein. The Company anticipates that subsequent events and developments may cause the Company s assessments to change. These
forward-looking statements should not be relied upon as representing the Company s assessment as of any date subsequent to the date of this communication. Accordingly, undue reliance should not be placed upon the forward-looking statements.
Neither the Company nor any of its affiliates undertakes any obligation to update these forward-looking statements, except as may be required by law.
Spectrum Science on behalf of NewAmsterdam
Stern Investor Relations on behalf of NewAmsterdam
NewAmsterdam Pharma Company N.V.
Consolidated Balance Sheets
| As at December 31, | ||||||||
| 2023 | 2022 | |||||||
| (In thousands of USD) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash | 340,450 | 467,728 | ||||||
| Prepayments and other receivables | 6,341 | 10,251 | ||||||
| Total current assets | 346,791 | 477,979 | ||||||
| Property, plant and equipment, net | 46 | 34 | ||||||
| Operating right of use asset | 55 | 120 | ||||||
| Intangible assets | 170 | 208 | ||||||
| Long term prepaid expenses | 35 | 156 | ||||||
| Total assets | 347,097 | 478,497 | ||||||
| Liabilities and Shareholders Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | 16,923 | 11,853 | ||||||
| Accrued expenses and other current liabilities | 11,398 | 6,117 | ||||||
| Deferred revenue, current | 8,942 | 13,874 | ||||||
| Lease liability, current | 60 | 66 | ||||||
| Derivative warrant liabilities | 12,574 | 4,147 | ||||||
| Total current liabilities | 49,897 | 36,057 | ||||||
| Deferred revenue, net of current portion | 1,019 | 4,792 | ||||||
| Lease liability, net of current portion | 60 | |||||||
| Derivative earnout liability | 7,788 | 7,522 | ||||||
| Total liabilities | 58,704 | 48,431 | ||||||
| Commitments and contingencies (Note 13) | ||||||||
| Shareholders Equity (deficit): | ||||||||
| Ordinary shares, 0.12 par value; 400,000,000 shares authorized; 82,469,768 and 81,559,780 shares issued and outstanding at December 31, 2023 and 2022, respectively | 10,173 | 10,055 | ||||||
| Additional paid-in capital | 590,771 | 555,625 | ||||||
| Accumulated loss | (316,973 | ) | (140,036 | ) | ||||
| Accumulated other comprehensive income (loss) | 4,422 | 4,422 | ||||||
| Total shareholders equity | 288,393 | 430,066 | ||||||
| Total liabilities and shareholders equity (deficit) | 347,097 | 478,497 |
NewAmsterdam Pharma Company N.V.
Consolidated Statements of Operations and Comprehensive Income (Loss)
| For the year ended December 31, | ||||||||||||
| 2023 | 2022 | 2021 | ||||||||||
| (In thousands of USD, except per share amounts) | ||||||||||||
| Revenue | 14,090 | 102,694 | ||||||||||
| Operating expenses: | ||||||||||||
| Research and development expenses | 159,424 | 86,744 | 28,974 | |||||||||
| Selling, general and administrative expenses | 37,633 | 19,507 | 6,003 | |||||||||
| Total operating expenses | 197,057 | 106,251 | 34,977 | |||||||||
| Operating loss | (182,967 | ) | (3,557 | ) | (34,977 | ) | ||||||
| Other income (expense): | ||||||||||||
| Interest income | 11,283 | |||||||||||
| Interest expense | (287 | ) | (411 | ) | ||||||||
| Loss on debt extinguishment | (883 | ) | ||||||||||
| Fair value change earnout and warrants | (10,284 | ) | (1,041 | ) | ||||||||
| Fair value change profit rights | (12,390 | ) | (20,613 | ) | ||||||||
| Fair value change tranche rights | 4,388 | 13,393 | ||||||||||
| Foreign exchange gains/(losses) | 5,058 | (9,747 | ) | 1,706 | ||||||||
| Loss before tax | (176,910 | ) | (22,634 | ) | (41,785 | ) | ||||||
| Income tax expense | 27 | |||||||||||
| Loss for the year | (176,937 | ) | (22,634 | ) | (41,785 | ) | ||||||
| Other comprehensive income (loss) | ||||||||||||
| Foreign currency translation adjustments | 11,126 | 286 | ||||||||||
| Income tax effects of other comprehensive income (loss) | ||||||||||||
| Total comprehensive income (loss) for the year, net of tax | (176,937 | ) | (11,508 | ) | (41,499 | ) | ||||||
| Net loss per ordinary share | ||||||||||||
| Basic and diluted | $ | (2.15 | ) | $ | (1.19 | ) | $ | (3.81 | ) |
NewAmsterdam Pharma Company N.V.
Consolidated Statements of Mezzanine Equity and Shareholders Equity (Deficit)
| Mezzanine Equity | Shareholders Equity | |||||||||||||||||||||||||||||||
| (In thousands of USD, except share amounts) | Shares | Amount | Shares | Amount | Additional Paid-In Capital | Accumulated Loss | Cumulative Translation Adjustments | Total Shareholders Equity | ||||||||||||||||||||||||
| Opening balance at January 1, 2021 | 5,000,000 | 55 | 2,702 | (68,802 | ) | (6,990 | ) | (73,035 | ) | |||||||||||||||||||||||
| Conversion of convertible debt | 1,111,115 | 12,953 | ||||||||||||||||||||||||||||||
| Series A Tranche I | 4,928,613 | 71,588 | ||||||||||||||||||||||||||||||
| Issuance of non-voting shares (CEO Restricted Share Award) | 285,714 | 3 | (3 | ) | ||||||||||||||||||||||||||||
| Share-based compensation | 718 | 718 | ||||||||||||||||||||||||||||||
| Total profit or loss and comprehensive loss for the year | (41,785 | ) | 286 | (41,499 | ) | |||||||||||||||||||||||||||
| As at December 31, 2021 | 6,039,728 | 84,541 | 5,285,714 | 58 | 3,417 | (110,587 | ) | (6,704 | ) | (113,816 | ) | |||||||||||||||||||||
| Equity contribution (Series A Tranche II) | 5,691,430 | 90,468 | ||||||||||||||||||||||||||||||
| Repayment of loan (CEO Restricted Share Award) | 747 | 747 | ||||||||||||||||||||||||||||||
| Elimination of old shares (NewAmsterdam Pharma shareholders) | (11,731,158 | ) | (175,009 | ) | (5,285,714 | ) | (58 | ) | (4,164 | ) | (4,222 | ) | ||||||||||||||||||||
| Equity contribution (NewAmsterdam Pharma shareholders) | 36,258,312 | 4,470 | 174,761 | 179,231 | ||||||||||||||||||||||||||||
| Equity contribution (FLAC shareholders) | 13,185,138 | 1,625 | 66,252 | 67,877 | ||||||||||||||||||||||||||||
| Equity contribution (PIPE Financing) | 23,460,000 | 2,892 | 231,708 | 234,600 | ||||||||||||||||||||||||||||
| Equity contribution (Amgen & MTPC shareholders) | 8,656,330 | 1,068 | 84,371 | 85,439 | ||||||||||||||||||||||||||||
| Transaction costs on issue of shares | (5,794 | ) | (5,794 | ) | ||||||||||||||||||||||||||||
| Earnout obligation upon Closing (NewAmsterdam Pharma shareholders) | (6,815 | ) | (6,815 | ) | ||||||||||||||||||||||||||||
| Share-based compensation | 4,327 | 4,327 | ||||||||||||||||||||||||||||||
| Total profit or loss and comprehensive loss for the year | (22,634 | ) | 11,126 | (11,508 | ) | |||||||||||||||||||||||||||
| As at December 31, 2022 | 81,559,780 | 10,055 | 555,625 | (140,036 | ) | 4,422 | 430,066 | |||||||||||||||||||||||||
| Exercise of warrants | 749,741 | 97 | 10,116 | 10,213 | ||||||||||||||||||||||||||||
| Exercise of stock options | 160,247 | 21 | 269 | 290 | ||||||||||||||||||||||||||||
| Share-based compensation | 24,761 | 24,761 | ||||||||||||||||||||||||||||||
| Total profit or loss and comprehensive loss for the year | (176,937 | ) | (176,937 | ) | ||||||||||||||||||||||||||||
| As at December 31, 2023 | 82,469,768 | 10,173 | 590,771 | (316,973 | ) | 4,422 | 288,393 |
NewAmsterdam Pharma Company N.V.
Consolidated Statements of Cash Flows
| For the year ended December 31, | ||||||||||||
| 2023 | 2022 | 2021 | ||||||||||
| (In thousands of USD) | ||||||||||||
| Operating activities: | ||||||||||||
| Loss for the year | (176,937 | ) | (22,634 | ) | (41,785 | ) | ||||||
| Non-cash adjustments to reconcile loss before tax to net cash flows: | ||||||||||||
| Depreciation and amortization | 49 | 9 | 5 | |||||||||
| Non-cash rent expense | 6 | 10 | 2 | |||||||||
| Amortization of discount on convertible note | 155 | |||||||||||
| Loss on extinguishment of convertible note | 883 | |||||||||||
| Fair value change - tranche rights | (4,388 | ) | (13,393 | ) | ||||||||
| Fair value change - IPR&D | 12,390 | 20,613 | ||||||||||
| Fair value change - derivative earnout and warrants | 10,284 | 1,041 | ||||||||||
| Foreign exchange (gains)/losses | (5,058 | ) | 9,747 | (1,706 | ) | |||||||
| Share-based compensation | 24,572 | 4,117 | 1,244 | |||||||||
| Changes in working capital: | ||||||||||||
| Changes in prepayments (current and non-current) and other receivables | 4,031 | (4,185 | ) | (5,232 | ) | |||||||
| Changes in accounts payable | 5,070 | 4,809 | 6,558 | |||||||||
| Changes in accrued expenses and other current liabilities | 5,470 | (8,679 | ) | 3,144 | ||||||||
| Changes in deferred revenue | (8,705 | ) | 18,428 | |||||||||
| Net cash (used in)/provided by operating activities | (141,218 | ) | 10,665 | (29,512 | ) | |||||||
| Investing activities: | ||||||||||||
| Purchase of property, plant and equipment, including internal use software | (24 | ) | (221 | ) | (24 | ) | ||||||
| Net cash used in investing activities | (24 | ) | (221 | ) | (24 | ) | ||||||
| Financing activities: | ||||||||||||
| Proceeds from issuing equity securities (Series A) | 90,469 | 84,704 | ||||||||||
| Proceeds from issuing equity securities (FLAC shareholders) | 71,883 | |||||||||||
| Proceeds from issuing equity securities (PIPE Financing) | 234,600 | |||||||||||
| Transaction costs on issue of shares | (5,794 | ) | ||||||||||
| Proceeds from payment of shareholder loan | 747 | |||||||||||
| Proceeds from exercise of warrants | 8,622 | |||||||||||
| Proceeds from exercise of options | 290 | |||||||||||
| Net cash provided by financing activities | 8,912 | 391,905 | 84,704 | |||||||||
| Net change in cash | (132,330 | ) | 402,349 | 55,168 | ||||||||
| Foreign exchange differences | 5,052 | 5,248 | (4,683 | ) | ||||||||
| Cash at the beginning of the year | 467,728 | 60,131 | 9,646 | |||||||||
| Cash at the end of the year | 340,450 | 467,728 | 60,131 | |||||||||
| Noncash financing and investing activities | ||||||||||||
| Derivative earnout obligation recognized related to the Business Combination (as defined in Note 3) | 6,815 | |||||||||||
| Liabilities assumed in the Business Combination (as defined in Note 3) | (4,006 | ) | ||||||||||
| Contribution of interest in NewAmsterdam Pharma Holding B.V. by Participating Shareholders (as defined in Note 3) | (179,231 | ) | ||||||||||
| Issuance of Ordinary Shares to Participating Shareholders (as defined in Note 3) | 179,231 | |||||||||||
| Issuance of Ordinary Shares pursuant to the Profit Right Agreement (as defined in Note 2) | 85,439 | |||||||||||
| Conversion of convertible debt to mezzanine equity | 12,953 | |||||||||||
| Recognition of ROU asset | 196 | |||||||||||
| Supplemental cash flow disclosures | ||||||||||||
| Cash paid for interest | 277 | |||||||||||
| Cash paid for income taxes | 27 |