Merck & Co (NYSE:MRK) Update / Briefing November 09, 2025 07:01 PM ET Speaker0Welcome to the Merkin Co. Incorporated, Rawlway, New Jersey, USA Investor Event. At this time, all participants are in a listen only mode until the question and answer session of today's conference. This call is being recorded. If you have any objections, you may disconnect at this time.I would now like to turn the call over to Mr. Peter Dannenbaum, Senior Vice President, Investor Relations. Sir, you may begin.Speaker1Thank you, I ...

Core Insights - Amgen's cholesterol drug Repatha has demonstrated a 25% reduction in major cardiovascular events for at-risk patients who have never experienced a heart attack or stroke [1] Group 1 - The addition of Repatha to standard therapy significantly benefits patients at risk for cardiovascular events [1]

Core Insights - Esperion announced acceptance of an oral and a poster presentation at the AHA Scientific Sessions 2025, highlighting ongoing research in cardiovascular health [1][2] Group 1: Presentations - The oral presentation will focus on bempedoic acid monotherapy, LDL cholesterol, and cardiovascular events, based on a secondary analysis of the CLEAR Outcomes trial [2] - A poster presentation will discuss the effects of bempedoic acid on venous thromboembolism, derived from a post-hoc analysis of the CLEAR Outcomes trial [2] Group 2: Company Overview - Esperion Therapeutics is a commercial stage biopharmaceutical company dedicated to developing new medicines for patients with unmet needs, particularly those at risk for cardiovascular disease [3] - The company has developed the only FDA-approved oral, once-daily, non-statin medications for patients struggling with elevated LDL cholesterol [3] - Esperion's CLEAR Cardiovascular Outcomes Trial involved nearly 14,000 patients, supporting the efficacy of its treatments [3] Group 3: Future Directions - Esperion is advancing its next-generation program focused on developing ATP citrate lyase inhibitors (ACLYi), leveraging new insights for rational drug design [3][4] - The company aims to evolve into a leading global biopharmaceutical entity through commercial execution and international partnerships [4]

Core Viewpoint - The FDA's recent update to fenofibrate drug labeling highlights the lack of cardiovascular benefits and aims to shift clinical practices towards therapies that are clinically proven to reduce cardiovascular events [1][2][3] Company Perspective - Amarin Corporation supports the FDA's decision, emphasizing the need for healthcare practitioners to stop prescribing fibrates for cardiovascular risk reduction, particularly in combination with statins, as this approach is outdated and ineffective [5][6] - The company advocates for the use of FDA-approved therapies like VASCEPA (icosapent ethyl) to reduce cardiovascular risks in patients with elevated triglycerides [6][10] Industry Context - Cardiovascular disease (CVD) is the leading cause of death globally, accounting for over 900,000 deaths annually in the U.S. and nearly 20 million worldwide [2] - Despite evidence from major clinical trials (FIELD, ACCORD Lipid, PROMINENT) showing that fenofibrates do not reduce cardiovascular event risks, over 11 million prescriptions were written in the U.S. in 2023, indicating a significant gap in clinical practice [3][4] - In Europe, fibrates are the third most commonly used lipid management agents, with an estimated two million patients treated with fibrates in Western Europe [4] Clinical Evidence - The FDA's labeling change is based on decades of clinical data demonstrating that fenofibrates do not provide cardiovascular benefits, even when used with statins [3] - The company highlights the importance of aligning treatment decisions with current scientific understanding to improve patient outcomes in cardiovascular health [7]

Core Insights - BridgeBio Pharma's heart-disease drug, Attruby, has shown promising results in reducing the risk of death by nearly 50% in an exploratory study, which could significantly impact treatment approaches for cardiomyopathy [1][2][4] Group 1: Drug Efficacy and Approval - Attruby is approved for treating cardiomyopathy due to transthyretin amyloidosis, with a 49% lower risk of death observed in patients after 30 months of treatment [2][5] - The drug's effects were noticeable within just one month of treatment, suggesting the need for earlier diagnosis and intervention [3][7] - Attruby has been marketed since late 2024, generating $5.9 million in its first quarter, which increased to $71.5 million in subsequent quarters, with a forecast of $94.9 million for the current quarter [5][6] Group 2: Market Potential and Competition - Analysts predict Attruby could become a blockbuster drug by 2027, competing against Pfizer's Vyndaqel, which generated $5.45 billion in sales last year [5][6] - The difference in outcomes between Attruby and placebo was significant, with 53 events prevented per 100 treated patients after 30 months [8] Group 3: Clinical Implications - The cardiologist Dr. Ahmad Masri emphasizes that Attruby could shift the treatment paradigm for TTR-related cardiomyopathy, focusing on preventing serious cardiovascular events [9][10] - Continuous treatment with Attruby is highlighted as crucial for improving patient longevity and quality of life, as recovery from heart failure episodes can be challenging [10]

Core Viewpoint - Novartis is set to acquire Tourmaline Bio, Inc. for $1.4 billion, enhancing its cardiovascular pipeline with the addition of pacibekitug, an anti-IL-6 monoclonal antibody targeting atherosclerotic cardiovascular disease (ASCVD) [1][3][7] Acquisition Details - Novartis will pay $48 per share in cash to Tourmaline shareholders, with the transaction expected to close in the fourth quarter of 2025 [3][7] - The acquisition aligns with Novartis' strategy to expand its pipeline through strategic acquisitions [9] Product Information - Pacibekitug is designed to mitigate systemic inflammation in ASCVD and has shown high affinity binding to IL-6, a key cytokine in systemic inflammation [4][7] - Phase II TRANQUILITY study results indicated that pacibekitug reduced median high-sensitivity C-reactive protein (hs-CRP) levels by 85% to 86% with safety profiles comparable to placebo [5][7] Market Reaction - Following the announcement of the acquisition and promising study results, shares of Tourmaline Bio surged by 57.8% [4][8] Strategic Focus - Novartis has been actively pursuing acquisitions to strengthen its pipeline, including a recent licensing agreement with Arrowhead Pharmaceuticals for ARO-SNCA [9][10] - The company also acquired Regulus Therapeutics for $0.8 billion, with potential additional payments of $0.9 billion based on regulatory milestones [11]

Core Insights - Esperion Therapeutics reported higher-than-expected GAAP results for Q2 2025, with revenue of $82.4 million, surpassing analyst estimates of $63.05 million, and a narrowed GAAP EPS loss of $0.02 compared to the expected loss of $0.15 [1][2][12] - The company achieved positive operating income from ongoing operations for the first time, indicating progress towards sustainable profitability [1][7] Financial Performance - GAAP revenue increased by 11.6% year-over-year from $73.8 million in Q2 2024 to $82.4 million in Q2 2025 [2] - U.S. net product revenue rose 42.4% year-over-year to $40.3 million, reflecting strong uptake of NEXLETOL and NEXLIZET [2][5] - Collaboration revenue decreased by 7.4% year-over-year to $42.1 million, but recurring collaboration revenue more than doubled compared to Q2 2024 [2][6] - Operating expenses declined by 5.5% year-over-year to $67.4 million, with R&D expenses dropping 37% [2][7] Product and Market Strategy - Esperion focuses on developing oral therapies for cholesterol management, particularly for patients who cannot tolerate statins, with NEXLETOL and NEXLIZET as its main products [3][10] - The company aims to expand market reach through new regulatory approvals and updated treatment guidelines, emphasizing physician acceptance and insurance coverage [4][10] - Recent prescription activity increased, with a 10% rise in retail prescriptions filled compared to the previous quarter [5] Collaboration and International Growth - Collaboration revenue, which includes royalties and milestone payments, constituted over half of total revenue, with significant contributions from partnerships like Daiichi Sankyo [6] - Over 500,000 European patients have received Esperion's therapies through its partnership with Daiichi Sankyo, with further international approvals expected in Japan, Canada, Israel, and Australia [6][12] Future Outlook - The company has a cash balance of $86.1 million as of June 30, 2025, down from $144.8 million at the end of 2024, with management focused on achieving sustainable profitability by early 2026 [12][13] - Esperion is developing a triple-combination oral therapy for LDL-C lowering, expected to launch in 2027, which aims to provide high-efficacy cholesterol reduction in a single tablet [11]

Clinical Program and Trial Results - NewAmsterdam Pharma completed enrollment for BROOKLYN, BROADWAY and PREVAIL Phase 3 studies[5] - The BROOKLYN Phase 3 trial, involving 354 participants with HeFH and LDL-C ≥70 mg/dL, has primary endpoint of LDL-C reduction at 12 weeks[46, 49] - The BROADWAY Phase 3 trial, involving 2,532 participants with ASCVD or HeFH and LDL-C ≥55 mg/dL, also has primary endpoint of LDL-C reduction at 12 weeks[46, 53] - The PREVAIL CVOT, involving 9,541 participants with ASCVD and LDL-C ≥55 mg/dL, has primary endpoint of 4-Point MACE+ with a minimum 30-month follow-up[46, 61] - Initial data from an Alzheimer's Disease sub-study showed that obicetrapib 10mg decreased 24s- & 27s-hydroxycholesterol in both plasma and cerebrospinal fluid in a phase 2a study (n=13)[55] Obicetrapib's Potential Benefits - Obicetrapib observed to lower small LDL-P by 90%+ and total particles by over 70% in combination with ezetimibe[24] - Obicetrapib 10 mg on top of high-intensity statins significantly lowered Lp(a) by 57% vs placebo, in ROSE[80] - Obicetrapib monotherapy observed a 43% mean LDL-C lowering[30] - Obicetrapib in combination with ezetimibe observed a 59% mean LDL-C lowering on top of high-intensity statins[31] Commercial Opportunity - Approximately 30 million+ patients in the US are not achieving LDL-C lowering goals despite standard-of-care[30] - The lipid-lowering therapy market has over 250 million prescriptions annually[164] - The market is growing at over 4% over the last 2 years, with the non-statin market growing at high double digits[164] Financial Position - NewAmsterdam Pharma had $481 million in cash as of 1Q24[225]

Core Insights - Amgen is presenting full results from the Phase 2 study of MariTide, a peptide-antibody conjugate for obesity and Type 2 diabetes, at the 85th American Diabetes Association Scientific Sessions [1][2] - The company is also sharing new data from the Phase 3 FOURIER study of Repatha® in cardiovascular disease [1] - MariTide shows promising 52-week efficacy, safety, and tolerability data, indicating robust weight loss without a plateau in patients with obesity [3][9] Company Overview - Amgen is focused on innovative medicines for serious diseases, with a strong pipeline that includes treatments for obesity and cardiovascular conditions [20][22] - The company has been recognized as one of the "World's Most Innovative Companies" and is part of the Dow Jones Industrial Average and Nasdaq-100 Index [23] Product Information - MariTide is a bispecific GLP-1 receptor agonist and GIPR antagonist, designed to provide a dual mechanism of action for weight loss and diabetes management [9] - Repatha® is a monoclonal antibody that lowers LDL cholesterol by inhibiting PCSK9, with extensive clinical trial data supporting its efficacy [13][14] Industry Context - The prevalence of obesity has more than doubled globally from 1990 to 2022, with significant health implications including increased risk for Type 2 diabetes and cardiovascular diseases [7][8] - Despite the recognition of obesity as a chronic disease, only 1%-3% of eligible adults in the U.S. receive pharmacologic treatment for weight management [8]

Alzheimer's Disease Update - Emerging evidence suggests a vascular component in multi-infarct dementia, implying LDL-lowering could reduce atherosclerosis in the brain [15] - Alzheimer's disease affects over 50 million people worldwide, with an economic burden exceeding $1 trillion [15] - ApoE4 carriers exhibit a 22-45% elevated risk for CVD [28] - In a proof-of-concept study in 13 ApoE4 carriers with MCI and biomarker-proven AD, obicetrapib showed significant reductions in plasma and CSF levels of 24S- and 27-hydroxycholeterol [41, 43] PREVAIL and MACE Reduction - BROADWAY study showed a 21% observed MACE reduction [98, 99] - In BROADWAY, patients on Obicetrapib had a 42% first 4-point MACE compared to 52% in the placebo group [90] - BROADWAY + BROOKLYN pooled data showed a 75% first 4-point MACE in the Obicetrapib group compared to 49% in the placebo group [91] - Mediation analysis predicts 26% of MACE reduction from Lp(a) in BROADWAY [132, 133] Market Opportunity and Commercial Launch - The lipid-lowering therapy market has shown growth each year for the last 5 years [172] - Repatha® experienced a +47% Rx growth in the last 12 months [172] - The company estimates an $8 billion+ potential worldwide market opportunity for Obicetrapib [247]