Core Insights - The investment represents a multi-million-dollar upgrade in equipment to enhance production capabilities for fixed dose combination (FDC) products [1][4] - The new manufacturing suite at the Sellersville facility will support the production of NewAmsterdam Pharma's investigational non-statin cholesterol medication aimed at reducing LDL-C [2][4] - The partnership between Piramal Pharma Solutions and NewAmsterdam Pharma is crucial for the development and production of the FDC, with significant contributions from Piramal's facilities in India [2][4] Company Developments - The new suite is expected to create over 20 new jobs at the Sellersville site over the next five years, contributing positively to the local economy [3] - The investment reflects a commitment to continuous improvement and operational efficiency, enabling both companies to meet future commercial demands for the FDC product [4] - NewAmsterdam Pharma is focused on developing obicetrapib, a low-dose CETP inhibitor, to address unmet needs in LDL-lowering therapies [5][6] Industry Context - NewAmsterdam Pharma operates in the late-stage clinical biopharmaceutical sector, targeting metabolic diseases with inadequate existing therapies [6] - Piramal Pharma Solutions is a Contract Development and Manufacturing Organization (CDMO) providing comprehensive services across the drug life cycle, enhancing its capabilities through this investment [7][8]

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]

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]