Financial Position - As of December 31, 2024, the company had cash and cash equivalents of $771.7 million, up from $340.5 million as of December 31, 2023, primarily due to proceeds from offerings and milestone achievements[570]. - Cash and cash equivalents as of December 31, 2024, were $771.7 million, with plans to utilize these funds primarily for research and development initiatives[600]. - As of December 31, 2024, the company had cash and cash equivalents of $771.7 million, sufficient to fund estimated obligations of $11.8 million due within one year[617]. - Net cash used in operating activities increased by $17.4 million from $141.2 million in 2023 to $158.6 million in 2024[613]. - Net cash flows provided by financing activities was $659.5 million in 2024, an increase of $650.6 million from 2023[615]. Clinical Trials and Research - The Phase 3 BROADWAY clinical trial demonstrated a statistically significant LDL-C reduction of 33% (p<0.0001) for obicetrapib compared to placebo[572]. - The Phase 3 TANDEM clinical trial achieved an LS mean reduction of LDL-C of 48.6% (p < 0.0001) for the fixed-dose combination of obicetrapib and ezetimibe compared to placebo[573]. - The Phase 3 BROOKLYN clinical trial met its primary endpoint with statistically significant reductions in LDL-C compared to placebo, with p-values <0.0001 for key secondary endpoints[574]. - Approximately 30 million patients in the U.S. do not reach their LDL-C goals despite lipid-lowering therapy, highlighting a significant unmet need in the market[566]. - Research and development expenses are expected to be significant as the company advances obicetrapib through clinical trials and regulatory approval processes[581]. Revenue and Expenses - Revenue increased by $31.5 million, or 223.4%, to $45.6 million for the year ended December 31, 2024, compared to $14.1 million for the year ended December 31, 2023[589]. - Research and development expenses decreased by $8.0 million, or 5.0%, to $151.4 million for the year ended December 31, 2024, compared to $159.4 million for the year ended December 31, 2023[590]. - Selling, general and administrative expenses increased by $32.8 million, or 87.2%, to $70.4 million for the year ended December 31, 2024, compared to $37.6 million for the year ended December 31, 2023[591]. - Loss for the year increased by $64.7 million, to $241.6 million for the year ended December 31, 2024, compared to $176.9 million for the year ended December 31, 2023[595]. - As of December 31, 2024, the accumulated loss was $558.6 million, with expectations of continued significant losses in the foreseeable future[598]. Partnerships and Licensing - The company has partnered with Menarini for the commercialization of obicetrapib in Europe, with plans to pursue U.S. development independently[568]. - The company has not generated revenue from product sales, relying solely on a $120.9 million upfront payment from Menarini for licensing[575]. - Menarini made a non-refundable upfront payment of €115 million and committed to provide €27.5 million for R&D activities over two years[605]. - As of December 31, 2024, the company received a total of €30 million in milestone payments from Menarini, with €25 million received in 2024[606]. Market and Future Outlook - The company anticipates increased expenses as it no longer qualifies as an "emerging growth company" and will face higher reporting requirements[570]. - The company's net exposure to foreign currency risk was $108.6 million, mainly related to the Euro, with a potential change in future earnings of approximately $1.1 million from a 1% change in exchange rates[628]. - The fair value of derivative warrant liabilities and derivative earnout liability as of December 31, 2024, were $37.5 million and $44.8 million, respectively[630]. - The company has not included potential cash proceeds from the exercise of Warrants in its liquidity projections[608].

Financial Performance - Revenue for the year ended December 31, 2024, was $45.6 million, up from $14.1 million in 2023, primarily due to clinical success milestones[9][15] - Revenue for the year ended December 31, 2024, was $45,563,000, a significant increase from $14,090,000 in 2023, representing a growth of 223%[20] - Net loss for the year ended December 31, 2024, was $241.6 million, compared to a net loss of $176.9 million in 2023[9][15] - The company reported a loss for the year of $241,598,000 in 2024, compared to a loss of $176,937,000 in 2023, indicating an increase in losses of approximately 36.5% year-over-year[25] - The operating loss for 2024 was $176,289,000, slightly improved from a loss of $182,967,000 in 2023[20] Cash and Assets - NewAmsterdam reported $834.2 million in cash, cash equivalents, and marketable securities as of December 31, 2024, an increase from $340.5 million at the end of 2023[2][9] - Cash and cash equivalents increased to $771,743,000 in 2024 from $340,450,000 in 2023, marking a growth of 126.6%[19] - Total assets rose to $864,620,000 in 2024, compared to $347,097,000 in 2023, indicating an increase of 149.5%[19] - Shareholders' equity increased to $757,500,000 in 2024 from $288,393,000 in 2023, a growth of 163.5%[19] Expenses - Research and Development expenses decreased to $151.4 million in 2024 from $159.4 million in 2023, attributed to reduced manufacturing and clinical costs[9][10] - Selling, General and Administrative expenses rose to $70.4 million in 2024, compared to $37.6 million in 2023, driven by increased personnel and marketing costs[9][15] - Total operating expenses for 2024 were $221,852,000, up from $197,057,000 in 2023, reflecting an increase of 12.6%[20] - The company incurred share-based compensation expenses of $33,619,000 in 2024, compared to $24,572,000 in 2023, marking a 36.8% increase[25] Clinical Trials and Regulatory Plans - The BROADWAY trial achieved a statistically significant LS mean LDL-C reduction of 33% (p<0.0001) at day 84 compared to placebo[6][7] - The TANDEM trial met all co-primary endpoints, achieving an LS mean LDL-C reduction of 49% (p<0.0001) at day 84 compared to placebo[6][7] - The BROOKLYN trial reported an LS mean LDL-C reduction of 36% (p<0.0001) at day 84 compared to placebo[6][7] - NewAmsterdam plans to submit for EMA approval in the second half of 2025 and is preparing for the potential launch of obicetrapib in the U.S. and Europe[3][4] - The company completed enrollment of over 9,500 patients in the PREVAIL Phase 3 trial in April 2024, which evaluates obicetrapib's impact on major adverse cardiac events[9][11] Cash Flow and Financing Activities - Net cash used in operating activities was $158,564,000 in 2024, an increase from $141,218,000 in 2023, reflecting a decline in operational cash flow[25] - The company generated net cash provided by financing activities of $659,507,000 in 2024, a significant increase from $8,912,000 in 2023, primarily due to new equity offerings[25] - The company reported a net cash used in investing activities of $62,848,000 in 2024, compared to $24,000 in 2023, indicating increased investment expenditures[25] Other Financial Changes - The fair value change of derivative earnout and warrants was $75,593,000 in 2024, a substantial increase from $10,284,000 in 2023[25] - Changes in working capital included a decrease in accounts payable by $12,948,000 in 2024, contrasting with an increase of $5,070,000 in 2023[25] - The company had cash paid for income taxes of $1,000 in 2024, a slight decrease from $27,000 in 2023[25] - The company recognized a noncash financing obligation related to the Business Combination of $6,815,000 in prior years, which was not present in the current year[25]

Core Insights - NewAmsterdam Pharma Company is advancing its development of obicetrapib, an oral, non-statin medicine aimed at lowering LDL-C in patients at risk of cardiovascular disease (CVD) [1][2][4] - The company reported significant financial results for 2024, including a net loss of $241.6 million, but also highlighted a strong cash position of $834.2 million as of December 31, 2024 [1][9][19] Clinical Development Updates - NewAmsterdam has completed three pivotal Phase 3 trials: BROADWAY, TANDEM, and BROOKLYN, all demonstrating significant LDL-C reduction [2][5][7] - The BROADWAY trial showed a 33% reduction in LDL-C with obicetrapib compared to placebo, while the TANDEM trial achieved a 49% reduction in a fixed-dose combination with ezetimibe [7][10] - The PREVAIL cardiovascular outcomes trial is ongoing, with over 9,500 patients enrolled, aimed at evaluating the impact of obicetrapib on major adverse cardiac events (MACE) [6][10] Financial Performance - For the year ended December 31, 2024, NewAmsterdam reported revenue of $45.6 million, a significant increase from $14.1 million in 2023, primarily due to clinical success milestones [9][19] - Research and development expenses decreased to $151.4 million from $159.4 million in the previous year, while selling, general, and administrative expenses rose to $70.4 million from $37.6 million [9][19] - The company’s cash and cash equivalents increased to $771.7 million from $340.5 million in 2023, driven by successful financing efforts [9][26] Regulatory and Market Outlook - An EMA submission for obicetrapib is anticipated in the second half of 2025, with plans to build inventory and commercial capabilities in preparation for potential U.S. and European launches [1][3][2] - The company aims to address the significant unmet need in the LDL-lowering therapy market, particularly for patients who are not adequately treated with existing therapies [12][11]

Core Insights - NewAmsterdam Pharma is a late-stage clinical biopharmaceutical company focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated low-density lipoprotein cholesterol [1][3] - The company aims to address the unmet need for safe and well-tolerated LDL-lowering therapies, particularly for patients who do not respond adequately to existing treatments [3] Company Overview - NewAmsterdam Pharma is investigating obicetrapib, a low-dose, once-daily CETP inhibitor, in multiple Phase 3 trials as a potential LDL-C lowering therapy [3] - The company is also exploring the use of obicetrapib in combination with ezetimibe as an adjunct to statin therapy for patients with elevated LDL-C [3] Upcoming Events - Company management will participate in the TD Cowen 45th Annual Healthcare Conference in Boston on March 4-5, 2025, with a presentation scheduled for 1:50 p.m. ET on March 4 [4] - The company will also present at the Leerink Partners Global Healthcare Conference in Miami on March 10, 2025, at 8:00 a.m. ET [4] - Additionally, management will be available for one-on-one meetings at the Jefferies Biotech on the Beach Summit in Miami on March 12, 2025 [4]

NewAmsterdam Pharma Company (NAMS) Conference February 05, 2025 10:00 AM ET Company Participants Debjit Chattopadhyay - Managing DirectorIan Somaiya - CFO Debjit Chattopadhyay Good morning, and thank you for joining Guggenheim's second Smitcap biotech conference. I'm Devjit, one of the therapeutic analysts here. And joining me from New Amsterdam Pharma is Chief Financial Officer, Ian Somayam. Thank you for your time, Ian. Ian Somaiya Thank you, Devjit. And I want to thank Guggenheim for the invitation. It's ...

Company Overview - NewAmsterdam Pharma Company N.V. is a late-stage clinical biopharmaceutical company focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease (CVD) with elevated low-density lipoprotein cholesterol (LDL-C) [1][3] - The company aims to address the unmet need for safe, well-tolerated, and convenient LDL-lowering therapies, particularly for patients who do not respond adequately to existing treatments [3] Product Development - NewAmsterdam is conducting multiple phase 3 trials for obicetrapib, an oral, low-dose, once-daily CETP inhibitor, which is being investigated as a standalone treatment and in combination with ezetimibe [3] - The target population includes patients at risk of CVD with elevated LDL-C levels, for whom current therapies are insufficiently effective or poorly tolerated [3] Upcoming Events - Ian Somaiya, the Chief Financial Officer of NewAmsterdam Pharma, will participate in a fireside chat at the Guggenheim SMID Cap Biotech Conference on February 5, 2025, at 10:00 a.m. ET [1] - A live webcast of the event will be available on the investor relations section of the NewAmsterdam Pharma website, with an archived replay to follow [2]

Core Insights - NewAmsterdam Pharma is advancing its clinical development program for obicetrapib, a CETP inhibitor aimed at lowering LDL-C in patients at risk of cardiovascular disease, with significant milestones expected in 2025 [1][2][12] Clinical Development - Positive topline results were announced for three pivotal Phase 3 trials: BROADWAY, TANDEM, and BROOKLYN, which demonstrated safety profiles comparable to placebo and significant LDL-C reductions [2][3][4] - The BROADWAY trial showed a 33% reduction in LDL-C (p<0.0001) and a 21% reduction in major adverse cardiovascular events (MACE) [4][6] - The TANDEM trial achieved a 49% reduction in LDL-C (p<0.0001) with the obicetrapib-ezetimibe combination [7] - The BROOKLYN trial reported a 36% reduction in LDL-C (p<0.0001) [7] Regulatory and Intellectual Property - NewAmsterdam plans to submit global regulatory filings for obicetrapib, including EMA submission in the second half of 2025 [1] - The company has secured a new patent for obicetrapib, providing protection until July 2043 in the U.S., with a total of nine patents issued or allowed [5] Financial Position - The company reported an unaudited cash balance of $835 million at year-end 2024, following an oversubscribed public offering [1][9] - This financial strength is expected to support operations through the anticipated PREVAIL cardiovascular outcomes trial readout and potential commercial launch of obicetrapib [2] Future Plans - NewAmsterdam aims to present additional data from its Phase 3 studies and publish findings in high-impact journals throughout 2025 [6][8] - The company is also focused on commercial readiness, including scaling up manufacturing capacity and building inventory for potential U.S. and European launches [9]

Core Insights - Menarini Group announced positive topline data from Phase 3 BROADWAY and TANDEM clinical trials, demonstrating the efficacy of Obicetrapib in reducing LDL-C levels significantly [1][17] - Obicetrapib achieved a 33% reduction in LDL-C compared to placebo in the BROADWAY trial, with a high statistical significance (p<0.0001) [4][15] - The fixed-dose combination of Obicetrapib and Ezetimibe in the TANDEM trial resulted in a 48.6% reduction in LDL-C compared to placebo, also with high statistical significance (p<0.0001) [10][11] Company Overview - NewAmsterdam Pharma is a late-stage biopharmaceutical company focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated LDL-C [1][20] - The Menarini Group is an international pharmaceutical and diagnostics company with a turnover of $4.7 billion, focusing on therapeutic areas with high unmet needs [19] Clinical Trial Details - The BROADWAY trial involved 2,530 patients with established ASCVD and/or HeFH, evaluating the efficacy of 10 mg Obicetrapib as an adjunct to maximally tolerated lipid-lowering therapies [14][17] - The TANDEM trial included 407 patients and assessed the fixed-dose combination of Obicetrapib and Ezetimibe against monotherapy and placebo [16][17] Safety and Tolerability - Both BROADWAY and TANDEM trials reported that Obicetrapib was well tolerated, with safety profiles comparable to placebo [5][10] - The treatment discontinuation rates were 11.1% for Obicetrapib and 12.4% for placebo in the BROADWAY trial, indicating similar tolerability [7] Market Implications - The positive results from these trials may provide new treatment options for patients who do not achieve LDL-C targets with existing therapies, addressing a significant unmet need in cardiovascular care [13][20] - The development of Obicetrapib aligns with the growing demand for effective LDL-lowering therapies, particularly in populations with high cardiovascular risk [18][20]

Core Viewpoint - NewAmsterdam Pharma Company N.V. has successfully closed a public offering of ordinary shares and pre-funded warrants, raising approximately $452.6 million to support its development of oral, non-statin medicines for cardiovascular disease patients [1][2]. Group 1: Offering Details - The public offering included 14,667,347 ordinary shares priced at $24.50 each, with an additional 2,550,000 shares purchased through underwriters' options [1]. - Pre-funded warrants to purchase 4,882,653 ordinary shares were also offered at a price of $24.4999 each, reflecting a minimal exercise price [1]. - The total net proceeds from the offering, after deducting underwriting discounts and commissions, amounted to approximately $452.6 million [2]. Group 2: Company Background - NewAmsterdam Pharma is a late-stage biopharmaceutical company focused on developing therapies for patients with elevated low-density lipoprotein cholesterol (LDL-C) who are at risk of cardiovascular disease [6]. - The company is investigating obicetrapib, a once-daily CETP inhibitor, in multiple phase 3 studies as a potential LDL-C lowering therapy, either alone or in combination with ezetimibe [6].

NAARDEN, The Netherlands and MIAMI, Dec. 13, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS; “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced the closing of the previously announced underwritten public off ...