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Esperion Therapeutics (ESPR) 2022 Earnings Call Presentation
2025-07-03 08:17
WHEN DO YOU PLAN TO GET YOUR NEXT CHOLESTEROL TEST? FORWARD-LOOKNG STATEMENTS & DISCLOSURES This presentation contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding marketing strategy and commercialization plans, restructuring and current and planned operational expenses, future operations, commercial products, clinical development including the timing, designs and plans for the CLEAR Outcomes study and its resu ...
NewAmsterdam Pharma Company (NAMS) FY Conference Transcript
2025-06-09 19:42
Summary of NewAmsterdam Pharma Company (NAMS) FY Conference Call Company Overview - **Company**: NewAmsterdam Pharma Company (NAMS) - **Focus**: Development of LDL lowering therapies, specifically elbocetropib Market Opportunity - The LDL lowering market has evolved significantly over the past 15 years, with guidelines shifting to recommend lower LDL targets for high-risk patients, specifically a target of 55 mg/dL [2][5] - The market for LDL lowering drugs is growing, with branded drugs like Repatha increasing by 40% and generic Ezetimibe by 20% [5] - Elbocetropib is positioned to lower LDL by 35% to 50%, making it a competitive option in the market [17] Product Differentiation - Elbocetropib is an LDL plus drug, offering additional benefits beyond LDL lowering, such as potential diabetes protection and Alzheimer's disease implications [6][14] - The drug is well tolerated, with adverse events comparable to placebo, making it appealing for primary care prescriptions [17] - Elbocetropib targets a patient population that does not qualify for injectable therapies, addressing a significant unmet need [18][19] Clinical Trials and FDA Interaction - NAMS has conducted three phase three trials (Brooklyn, Broadway, and Tandem) demonstrating significant LDL lowering efficacy [25][26] - The FDA has requested a dedicated blood pressure trial and an outcome study during the review period, which is expected to read out by the end of 2026 [27][28] - The Broadway trial showed a 21% MACE benefit, indicating potential cardiovascular advantages [29] Financial Position - NAMS has over $800 million in cash, providing a strong financial position for upcoming launches and trials [39][40] - The company is preparing for a structured commercial rollout, with a focus on timing regulatory filings and launch strategies [42] Partnerships and Market Strategy - NAMS has a partnership with Metarini in Europe, which provided significant upfront payments to support the company’s financial needs [43][44] - The company is exploring options for a potential partnership in the U.S. but is currently focused on a go-alone strategy to maximize shareholder value [46] Regulatory Environment - The company is monitoring drug pricing policy dynamics, particularly in relation to its European partner, which may provide some advantages regarding pricing control [49][50] Upcoming Catalysts - Key upcoming events include an R&D Day where further data on MACE benefits and atherosclerosis will be presented, as well as a presentation at the AIC meeting on July 30 [51][53] - The company plans to file for approval in Europe in the second half of the year and is working on a study combining elbocetropib with PCSK9 inhibitors [57] Conclusion - NewAmsterdam Pharma is positioned to capitalize on the growing LDL lowering market with its innovative product, elbocetropib, which offers unique benefits and a strong clinical profile. The company is well-financed and strategically planning for future growth and regulatory approvals.
NewAmsterdam Pharma to Host R&D Day on June 11, 2025
GlobeNewswire News Room· 2025-06-05 12:00
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]
NewAmsterdam Pharma Company (NAMS) FY Conference Transcript
2025-06-03 21:20
NewAmsterdam Pharma Company (NAMS) FY Conference June 03, 2025 04:20 PM ET Speaker0 Hi, everyone. Thanks for coming. My name is Matt Phipps, biotechnology analyst here at William Blair. I'm glad to announce happy to announce the next company at our Growth Stock Conference. It's New Amsterdam Pharma with Michael Davidson, one of the CEO and and cofounders. It's a, you know, company that's had a lot of success over the past, you know, really couple years, but really demonstrating some great clinical data with ...
NewAmsterdam Pharma to Participate at Upcoming Investor Conferences in June
Globenewswire· 2025-05-27 12:00
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]
Esperion(ESPR) - 2025 FY - Earnings Call Transcript
2025-05-20 15:00
Esperion Therapeutics (ESPR) FY 2025 Conference May 20, 2025 10:00 AM ET Speaker0 Okay. Welcome back, everybody. My name's Joe Panginas, managing director here at, HC Wainwright. Very happy to have with us Esperion Therapeutics. And, also nice to have the second commercial stage, company that I'm, doing a fireside chat with today. So it's very refreshing in the small cap biotech space, which, you don't necessarily apply to. So presenting for the company is Ben Halliday, chief financial officer. Ben, thank y ...
Esperion Therapeutics (ESPR) 2025 Conference Transcript
2025-05-08 17:30
Esperion Therapeutics (ESPR) 2025 Conference May 08, 2025 12:30 PM ET Speaker0 I guess take a step back and Primary. I guess take a step back and go go through the data that went into those new labels. Can you just walk us through the clear outcome study and the findings there? Speaker1 So the clear outcome study was a 14,000 patient outcome study which measured MACE four, MACE three in a variety of endpoints in both a, in a non statin population in both a primary and secondary prevention patient population ...
NewAmsterdam Pharma Provides Corporate Update and Reports First Quarter Financial Results
Globenewswire· 2025-05-08 12:00
– EMA submission expected in 2H25 by partner Menarini – – PREVAIL Phase 3 CVOT remains on track – -- BROADWAY and TANDEM results presented at EAS with simultaneous publications in the New England Journal of Medicine and The Lancet, respectively -- -- Company to host R&D day on June 11th, 2025 in New York City -- –$808.5 million in cash, cash equivalents and marketable securities at March 31, 2025 – NAARDEN, The Netherlands and MIAMI, May 08, 2025 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasda ...
Esperion Partners with HLS Therapeutics to Commercialize NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) in Canada
Globenewswire· 2025-05-08 10:30
– Esperion to Receive an Upfront Payment, Near-Term Milestones and Tiered Royalties on Product Sales – – Further Expands Global Access to Bempedoic Acid Products and Provides Opportunity to Bring Innovative Preventative Therapy to 2.6 million Canadians Living with Diagnosed Heart Disease – ANN ARBOR, Mich., May 08, 2025 (GLOBE NEWSWIRE) -- Esperion Therapeutics (NASDAQ: ESPR) today announced it has entered into a license and distribution agreement with HLS Therapeutics (TSX:HLS) for the exclusive rights to ...
NewAmsterdam Pharma Announces Late-Breaking Data from BROADWAY and TANDEM Pivotal Studies Published in Leading Medical Journals and Presented at the European Atherosclerosis Society (EAS) Congress 2025
Globenewswire· 2025-05-07 11:15
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]