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][5] - 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 [5] R&D Day Announcement - NewAmsterdam will host an R&D Day event for analysts and investors on June 11, 2025, at 9:00 a.m. ET in New York City [1] - The event will feature key members of the management team, including the CEO and Chief Scientific Officer [2] Obicetrapib Development - Obicetrapib is a novel, oral, low-dose CETP inhibitor being developed by NewAmsterdam to improve LDL-lowering treatment outcomes [4] - The company has conducted multiple Phase 2 and Phase 3 trials, demonstrating statistically significant LDL-lowering effects with a side effect profile similar to placebo [4] - The Phase 3 PREVAIL CVOT trial, which commenced in March 2022, has enrolled over 9,500 patients to assess obicetrapib's potential in reducing major adverse cardiovascular events (MACE) [4] Commercialization Rights - The commercialization rights for obicetrapib in Europe have been exclusively granted to the Menarini Group, a leading international pharmaceutical and diagnostics company [4]

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 - The company will participate in several investor conferences: - William Blair 45th Annual Growth Stock Conference in Chicago, IL on June 3, 2025, with a presentation by CEO Michael Davidson at 3:20 p.m. CT [4] - Jefferies Global Healthcare Conference 2025 in New York, NY on June 4, 2025, featuring a fireside chat with CFO Ian Somaiya at 10:30 a.m. ET [4] - Goldman Sachs 46th Annual Healthcare Conference in Miami, FL on June 9, 2025, with participation from CEO Michael Davidson and EVP Matthew Philippe at 2:40 p.m. ET [4] Investor Relations - Live webcasts of the presentations will be available on the investor relations section of the NewAmsterdam Pharma website, with archived replays accessible afterward [2]

Financial Data and Key Metrics Changes - The company reported growth in Q2, overcoming headwinds faced in Q1, particularly related to Medicare and overall market conditions [4] - Prescription growth began to exceed expectations around mid-March, with co-pay issues for Medicare patients significantly reduced [5] Business Line Data and Key Metrics Changes - The lead products, NEXLETOL and NEXLASET, have seen increased traction, particularly in the statin intolerant population, which has been positively received by physicians [6][12] - The sales force has effectively communicated the benefits of the products, leading to a doubling or tripling of new prescribers since the statin intolerance campaign [12] Market Data and Key Metrics Changes - In Europe, the company has experienced consistent growth, with Daiichi Sankyo reporting 20-30% growth each quarter since launch [15] - The company is catching up with Daiichi in Europe, indicating a strong competitive position [15] Company Strategy and Development Direction - The company plans to develop a triple combination therapy in the U.S., which includes bempedoic acid, ezetimibe, and two commonly prescribed statins [17][18] - The company is also pursuing international agreements, with Otsuka Pharmaceuticals commercializing the product in Japan and other agreements in Canada, Australia, and Israel [21][22][24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about reaching profitability soon, with a growth trajectory that supports self-funding for future projects [42][43] - The company is excited about the potential of a new compound targeting primary sclerosing cholangitis (PSC), which represents a significant market opportunity [37][38] Other Important Information - The company has a strong patent portfolio, with potential extensions beyond 2031, which could reshape the company's financial outlook [28][30] - The recent settlement with MicroLabs regarding generic Nexletol is confidential, but management believes it sets a precedent for future negotiations with other ANDA filers [26][29] Q&A Session Summary Question: How are revenues tracking for NEXLETOL and NEXLASET? - Management noted that Q2 is off to a great start, with prescription growth exceeding expectations since mid-March [4][5] Question: What is the current target population for NEXLETOL and NEXLASET? - The focus is on the statin intolerant population, which has been well received by physicians [6] Question: Can you comment on the expansion of the drug in Europe? - Daiichi Sankyo has shown consistent growth in Europe, and the company expects to surpass them eventually [15] Question: What are the plans for a triple combination therapy? - The company is developing a triple combination therapy that could significantly improve patient adherence and outcomes [17][18] Question: What is the timeline for the PSC drug development? - The PSC drug is currently in preclinical stages, with expectations to launch in the early 2030s [41] Question: How does the company view its path to profitability? - Management is optimistic about reaching profitability soon, with a solid growth trajectory and cash position [42][43]

Summary of Esperion Therapeutics (ESPR) Conference Call Company Overview - **Company**: Esperion Therapeutics (ESPR) - **Event**: 2025 Conference - **Date**: May 08, 2025 Key Points Industry and Product Insights - **Study Results**: The CLEAR Outcomes study involved 14,000 patients and demonstrated a nearly 40% reduction in major adverse cardiovascular events (MACE) in primary prevention settings, which is significant for patients who have not yet experienced cardiovascular events [1][2] - **Market Opportunity**: The drug provides an alternative for patients who cannot tolerate statins, with up to 30% of the population unable to achieve their cardiovascular health goals with statins alone [2] - **Patient Population**: The new label allows access to approximately 70 million patients in the U.S., significantly expanding the potential market [9] Launch and Sales Strategy - **Initial Launch Challenges**: The drug was launched in March 2020, coinciding with the COVID-19 pandemic, which complicated initial sales efforts [4] - **Sales Force Restructuring**: The company reduced its sales force from 300 to 70 representatives in October 2021, focusing on consistent quarterly growth and achieving positive outcomes from the CLEAR Outcomes trial [6][8] - **Reimbursement Improvements**: Post-label update, reimbursement access improved significantly, with many major payers eliminating prior authorization requirements, facilitating easier access for patients [10][11] Physician and Patient Feedback - **Physician Reception**: Physicians have responded positively to the drug, appreciating the compelling outcomes data and the drug's tolerability [12][15] - **Awareness Campaigns**: The company is focusing on increasing awareness among physicians and patients through targeted digital marketing strategies [19][20] Market Dynamics - **Market Share**: The drug is primarily being used in the primary prevention setting, with a significant portion of the 70 million patient market being targeted [22] - **Growth Trends**: The company experienced double-digit growth in prescriptions, although the first quarter of the year saw some slowdown due to changes in Medicare [23][24] Financial and Operational Updates - **Debt Management**: The company successfully restructured its debt, reducing $700 million in debt and deferring $265 million in convertible notes to 2030, improving its capital structure [50][51] - **Cash Position**: As of Q1, the company had approximately $114 million in cash, with expectations for improved cash flow as the year progresses [59] Future Developments - **New Drug Development**: The company is pursuing a triple combination therapy involving bempedoic acid, ezetimibe, and statins, aiming for significant LDL-C reduction [37][38] - **Expansion Plans**: Esperion is also exploring opportunities in other markets, including Japan and Canada, with partnerships established for launches in these regions [62] Competitive Landscape - **Loss of Exclusivity**: The company is aware of nine ANDA filers for generics but believes it has solid intellectual property protection until mid-2031, with additional patents extending to 2040 [34][36] Research and Development - **New Indications**: The company is exploring treatments for familial hypocholesterolemia and primary sclerosing cholangitis, indicating a commitment to expanding its therapeutic portfolio [42][48] Conclusion Esperion Therapeutics is positioned to capitalize on its recent label updates and improved reimbursement access, targeting a significant market of patients who cannot tolerate statins. The company is focused on growth through strategic marketing, debt management, and new product development, while navigating the competitive landscape of cardiovascular therapies.

Core Insights - NewAmsterdam Pharma is advancing its clinical development of obicetrapib, an oral, low-dose CETP inhibitor aimed at lowering LDL-C in patients at risk of cardiovascular disease (CVD) [4][14] - The company reported a cash position of $808.5 million as of March 31, 2025, indicating strong financial backing for ongoing and future projects [11][3] - NewAmsterdam plans to submit for EMA approval in the second half of 2025 through its partner Menarini, highlighting its regulatory progress [3][4] Financial Performance - For the first quarter of 2025, NewAmsterdam recognized $3.0 million in revenue, up from $1.4 million in the same period in 2024, primarily due to increased transaction prices related to R&D contributions from Menarini [11] - Research and Development (R&D) expenses increased to $44.8 million in Q1 2025 from $42.4 million in Q1 2024, driven by higher personnel costs and investments in pipeline expansion [11] - Selling, General and Administrative (SG&A) expenses rose significantly to $27.2 million in Q1 2025 from $14.5 million in Q1 2024, reflecting increased costs associated with the planned commercial launch of obicetrapib [11] Clinical Development Updates - NewAmsterdam is conducting several pivotal Phase 3 trials, including PREVAIL, which has enrolled over 9,500 patients to evaluate obicetrapib's impact on major adverse cardiac events (MACE) [5][10] - The company is also progressing with the VINCENT Phase 2 trial, assessing the effects of obicetrapib alone and in combination with evolocumab on lipoprotein (a) [5] - The REMBRANDT Phase 3 trial will evaluate the effect of obicetrapib plus ezetimibe on coronary plaque in high-risk ASCVD patients [6] Corporate Updates - NewAmsterdam appointed Adele Gulfo to its Board of Directors in April 2025, bringing over three decades of pharmaceutical experience [7] - The company will host an R&D Day on June 11, 2025, to discuss its research and development initiatives [8] Market Context - Cardiovascular disease remains a leading cause of death globally, with a significant unmet need for effective LDL-C lowering therapies, as many patients do not achieve their LDL-C goals with current treatments [13][14] - The company aims to address the needs of the approximately 30 million under-treated U.S. adults who are not at their risk-based LDL-C goal [13]

Core Insights - NewAmsterdam Pharma has presented compelling clinical data from the BROADWAY and TANDEM Phase 3 trials, demonstrating significant reductions in LDL-C and Lp(a) levels, which are critical for patients at risk of cardiovascular disease [1][2][6] Company Overview - NewAmsterdam Pharma is a late-stage clinical biopharmaceutical company focused on developing oral, non-statin medications for patients with elevated LDL-C who are at risk of cardiovascular disease [1][13] - The company is investigating obicetrapib, a low-dose CETP inhibitor, as a potential adjunct therapy to statins for improving LDL-C levels [8][13] Clinical Trial Findings - The BROADWAY trial showed that obicetrapib reduced LDL-C by 50% when used with statins and by 35% as monotherapy, with a notable 21% reduction in major adverse cardiovascular events [4][5] - The TANDEM trial demonstrated that the fixed-dose combination of obicetrapib and ezetimibe achieved a statistically significant LDL-C reduction of 48.6% compared to placebo [3][4] - Pooled data from the BROADWAY, TANDEM, and BROOKLYN trials indicated a median placebo-adjusted reduction of 45% in Lp(a) levels after 12 weeks of treatment [6][7] Market Context - Cardiovascular disease remains the leading cause of death globally, with a significant number of patients unable to reach their LDL-C goals despite the availability of lipid-lowering therapies [9][12] - Approximately 30 million under-treated adults in the U.S. are not at their risk-based LDL-C goal, highlighting a substantial clinical need for effective therapies [12] Future Prospects - The data presented at EAS 2025 is expected to support global regulatory filings for obicetrapib, reinforcing its potential as a foundational therapy in cardiovascular disease management [2][7] - The company has completed enrollment for the Phase 3 PREVAIL trial, which aims to assess the impact of obicetrapib on major adverse cardiovascular events [8]

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 grew 63% year over year to $65 million after adjusting for a one-time milestone received in Q1 2024 [7][19] - U.S. net product revenue increased 41% year over year to $34.9 million, driven by expanded label and commercial initiatives [7][19] - Collaboration revenue decreased approximately 73% to $30.1 million due to the settlement agreement milestone with DSE, but grew 97% excluding that milestone [21] Business Line Data and Key Metrics Changes - U.S. product sales growth was impacted by a flat lipid market and seasonal headwinds, with script growth increasing only 2% sequentially compared to Q4 2024 [7][20] - The market access team achieved significant milestones, including the removal of prior authorizations for over 30 plans, enhancing access for patients [8][10] - The company expanded its field reimbursement support team threefold to 15 specialists, improving support for prescribers [7][38] Market Data and Key Metrics Changes - The company reported that approximately 472,500 patients have been treated with its therapies in Europe, with royalty revenue from DSE increasing 8% from Q4 2024 to $10.5 million in Q1 2025 [13][14] - The Japanese market is expected to be a significant contributor, with approval for bempedoic acid anticipated in the second half of 2025 [14] Company Strategy and Development Direction - The company is focused on revenue growth, portfolio expansion, and pipeline advancement, with a commitment to improving cardiovascular health [5][23] - A new triple combination product is being developed, expected to provide significant LDL cholesterol reduction and is projected for commercialization in 2027 [12][62] - The company aims to leverage its leadership in ACLY biology and expand into high-need indications, such as primary sclerosing cholangitis (PSC) [16] Management's Comments on Operating Environment and Future Outlook - Management noted that the first quarter faced challenges due to changes in Medicare Part D and higher out-of-pocket costs, but early Q2 trends show prescription volume tracking approximately 8% higher than Q1 [20][58] - The management expressed confidence in the strategic initiatives to drive growth and improve patient access to innovative therapies [23][24] Other Important Information - The company reiterated its full-year 2025 operating expense guidance of approximately $215 million to $235 million, including $15 million in non-cash expenses related to stock compensation [22] - The company is actively pursuing new business development opportunities and is not waiting for specific milestones to execute deals [29] Q&A Session Summary Question: When should we expect a new business development deal? - Management is making good progress but will not set a timeline for a deal, as they want to ensure it makes sense for the company [29] Question: Is the triple combination a defensive strategy? - The triple combination is seen as a convenient option for patients, potentially being the most efficacious LDL-lowering drug on the market [31] Question: Is the sales force right-sized? - The current sales force of approximately 155 representatives is deemed appropriate, balancing personal and digital promotion [37] Question: How is the company addressing physician education on statin intolerance? - The company is focusing on educating physicians about statin intolerance, with significant traction in messaging about the unmet need for patients who cannot tolerate statins [40] Question: What is the gross margin trajectory? - Gross margin is influenced by the sales mix between U.S. and partner sales, with expectations for improvement as tech transfer progresses [65]

Core Insights - NewAmsterdam Pharma is presenting new clinical and preclinical data on obicetrapib, an oral, low-dose therapy for hypercholesterolemia, at the European Atherosclerosis Society Congress in May 2025 [1] - The company aims to address the unmet need for effective LDL-C lowering therapies for patients at risk of cardiovascular disease [4] Clinical Trial Presentations - A Phase 3 randomized trial on the fixed-dose combination of obicetrapib and ezetimibe for LDL-C reduction will be presented on May 5, 2025 [2] - Safety and efficacy data of obicetrapib in high cardiovascular risk patients will also be discussed on the same day [2] Additional Session Details - Obicetrapib's effects on atherosclerosis and vascular inflammation will be presented, highlighting its role in reducing non-HDL cholesterol and improving lesion stability [3] - The therapy's impact on reverse cholesterol transport and its safety in combination with moderate-dose statins will be showcased in various sessions [3] Company Overview - NewAmsterdam Pharma focuses on developing oral, non-statin medicines for patients with elevated LDL-C, aiming to improve patient care in populations with metabolic diseases [4] - The company is conducting multiple Phase 3 trials to investigate obicetrapib as a CETP inhibitor, both alone and in combination with ezetimibe [4]