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Innoviva (NasdaqGS:INVA) FY Conference December 02, 2025 04:30 PM ET Speaker1Welcome again to the 37th Annual Piper Sandler Healthcare Conference. This is David Amsellem from the Piper BioPharma Research Team, and our next company, Fireside Chat, is Innoviva. We have Pavel Raifeld, CEO, and Austin Hackett, VP and Director of Business Development. I hope I got the title right. All right, that's good. So we'll just go right into questions. And by the way, thanks so much for joining us this year. Just at a hig ...

Question-and-Answer SessionBob, do you want to start out and just sort of set the scene and tell us...Robert DugganCo-CEO & Executive Chairman It's been a great journey to get here and, Yigal, you're at the top of the list of the way you dig in, your diversification and flexibility. This guy can do anything from play the piano to race cars to evaluate companies quite accurately. So Summit has been in existence for quite a while. I bought a 25% interest in the company when it was in the anti-infective busin ...

The U.S. stock market demonstrated a strong rebound on Tuesday, December 2nd, 2025, with major indexes shaking off Monday's losses and regaining upward momentum. Investors showed renewed optimism, driven by stabilizing bond yields and a recovery in cryptocurrency markets, coupled with growing expectations for Federal Reserve interest rate cuts in the near future. This positive sentiment propelled technology stocks higher, contributing significantly to the day's gains across Wall Street.Market Performance Re ...

Summary of Supernus Pharmaceuticals FY Conference Call Company Overview - **Company**: Supernus Pharmaceuticals (NasdaqGM:SUPN) - **Event**: 37th Annual Piper Sandler Healthcare Conference - **Date**: December 02, 2025 Key Points Industry and Product Focus - **Product in Focus**: APO-go, a treatment for movement disorders, particularly for patients with advanced Parkinson's disease [1][2] - **Market Demand**: There is significant demand for APO-go, with physicians expressing strong support for the product despite current supply constraints [3][4] Supply Chain Challenges - **Current Situation**: The existing manufacturer is facing capacity issues, unable to meet the overwhelming demand for APO-go [5][6] - **Resolution Efforts**: Supernus is exploring multiple avenues to resolve supply constraints, including discussions with the FDA and potential partnerships with alternative suppliers [2][3][10] - **Timeline for Solutions**: Onboarding a new manufacturer could take several months to a year, depending on regulatory approvals and readiness [7][8][9] Patient Demand and Enrollment - **Patient Enrollment Forms (PEFs)**: Despite supply issues, physicians continue to submit PEFs, indicating ongoing interest in APO-go [14][15] - **Patient Demographics**: Initial demand is primarily from patients with advanced Parkinson's disease who have limited treatment options [19][20] Financial Projections - **Sales Estimates**: Initial peak sales estimates for APO-go are projected between $200 million and $300 million, which may need to be revisited once supply issues are resolved [20][21] - **Long-term Outlook**: The long-term potential for APO-go remains strong, as it offers a unique treatment option not available in the current market [21][22] Competitive Landscape - **Market Competition**: APO-go faces competition from other products like Vyalev and Apokyn, but it serves a different purpose as a rescue medication [25][26] - **Product Differentiation**: APO-go is positioned as a unique treatment option, distinct from traditional therapies like Levodopa [21][22] New Product Developments - **Zurzuvae**: Another product in the portfolio targeting postpartum depression, with significant market potential as it addresses a large unmet need [32][33] - **Sales Strategy**: The sales force is primarily targeting OB-GYNs, with potential for expansion based on market response [34][36] M&A and Future Strategy - **M&A Focus**: Supernus is prioritizing commercial-stage assets and is open to acquiring later-stage development programs [47][48] - **Partnership with Biogen**: There is potential for discussions regarding the buyout of Biogen's 50% stake in Zurzuvae, although both companies are currently committed to the brand [46] Financial Synergies - **Cost Synergies**: Supernus anticipates realizing up to $200 million in annualized synergies from the acquisition of Sage Therapeutics [42] Research and Development - **Early-stage Assets**: Supernus is evaluating early-stage assets from Sage and its own pipeline to determine which programs to advance [43][44] Conclusion Supernus Pharmaceuticals is navigating significant supply chain challenges with its APO-go product while maintaining strong demand and interest from healthcare providers. The company is also expanding its product portfolio with Zurzuvae and exploring strategic M&A opportunities to enhance its market position.

Summary of NewAmsterdam Pharma Company FY Conference Call Company Overview - **Company**: NewAmsterdam Pharma Company (NasdaqGM:NAMS) - **Focus**: Cholesterol-lowering therapies, specifically the drug obicetrapib Key Points Industry Context - The cholesterol-lowering market is significant, with approximately **30 million patients** in the U.S. diagnosed with hypercholesterolemia who are not achieving their LDL goals [21] - The market for lipid-lowering therapies is projected to be **$5 billion or higher** [63] Product Development and Regulatory Timeline - NewAmsterdam has completed three positive Phase III studies for obicetrapib, focusing on LDL reduction [9] - Regulatory filing in Europe has been accepted, with approval expected in **2026** [9] - The U.S. regulatory filing is dependent on the outcomes of the PREVAIL study, which is expected to provide data at the time of commercial launch [11][17] Competitive Landscape - NewAmsterdam positions obicetrapib as a unique CETP inhibitor, differentiating it from PCSK9 therapies [16] - Merck is also developing a PCSK9 therapy, with plans to file for approval in the first half of **2026** [44] - The company believes it can outperform Merck in market share due to the distinct advantages of obicetrapib [59] Clinical Data and Efficacy - Obicetrapib is expected to achieve **35%-40%** LDL reduction as a monotherapy and **50%-55%** in combination with ezetimibe [42] - The drug has shown a **15% reduction** in the rate of new-onset diabetes, which is a significant benefit for patients at risk [22] - The adverse event profile of obicetrapib is favorable, with lower rates of adverse events compared to placebo [43] Market Access and Pricing Strategy - The focus is on maximizing payer access at launch, with pricing strategies aligned with existing market frameworks [26] - The current pricing paradigm in the U.S. involves high list prices with lower net prices due to discounting [27] Future Opportunities - NewAmsterdam is exploring the potential of obicetrapib in treating Alzheimer's, with plans for a Phase IIB trial focusing on biomarkers related to Alzheimer's function [86] - The company aims to engage with the FDA to discuss the path forward for Alzheimer's treatment [88] Methodology and Data Reporting - NewAmsterdam uses the beta-quant method for LDL measurement, which is consistent with industry standards [82] - The company is aware of the variability in LDL measurement methods and aims to provide clarity in its data reporting [80] Conclusion - NewAmsterdam Pharma is positioned to enter the cholesterol-lowering market with a unique product that addresses significant unmet needs. The company is focused on regulatory approvals, competitive differentiation, and maximizing market access while exploring additional therapeutic areas such as Alzheimer's.

Summary of Corbus Pharmaceuticals Holdings FY Conference Call Company Overview - Corbus Pharmaceuticals Holdings is a drug development company based in Norwood, Massachusetts, with a focus on oncology and obesity [4][5] - The company has a small team of approximately 40 employees and emphasizes its preference for remaining small [4] Key Pipeline Developments ADC Program for Nectin-4 - The company is focusing on its ADC program for Nectin-4, with key milestones expected in the next 18 months [7] - Upcoming regulatory updates and data releases are planned for: - Q1: Regulatory update on pivotal study for Nectin-4 ADC monotherapy in second-line head and neck cancer [5] - Mid-year: Data on monotherapy for head and neck cancer, with a focus on durability [5] - Second half of the year: Data on monotherapy for cervical cancer and combination therapy with Keytruda in front-line head and neck cancer [5][6] CB1 Program for Obesity - The company is preparing to release SAD/MAD data imminently, with a significant study on obese non-diabetics planned for mid-year [6][19] - The phase 1 study design includes a classic SAD/MAD approach, with dosing up to hundreds of milligrams per day to assess safety and pharmacokinetics [19][20] Market Context and Competitive Landscape - The second-line treatment landscape for head and neck cancer is described as grim, with current therapies offering limited efficacy [7][8] - The company aims to differentiate its therapies based on safety profiles, particularly in terms of lower neuropathy and ocular toxicity compared to competitors like Padcev [16][17] Financial Position - Corbus Pharmaceuticals has extended its cash runway into 2028, providing a stable financial foundation for upcoming studies and developments [7] Strategic Focus - The company prioritizes investment in second-line monotherapy for head and neck cancer, followed by cervical cancer, with a wildcard focus on front-line combination therapy [30][32] - The potential for combination therapies with GLP-1 agonists is also being explored, with preclinical data showing promising results [28][29] Additional Insights - The company is cautious about expanding its focus beyond its current pipeline due to resource limitations, although it remains open to exploring other tumor types that express Nectin-4 [10][11] - The safety profile of CRB-701 is highlighted as a potential commercial advantage, particularly its low levels of peripheral neuropathy, which is a significant concern for patients [16][17] Conclusion - Corbus Pharmaceuticals is positioned to make significant advancements in its ADC and CB1 programs over the next year, with a clear focus on regulatory milestones and data releases that could shape its future in the oncology and obesity markets [5][6][30]

Question-and-Answer SessionTo start, maybe, Rich, you could just like level set for us for those that might not be familiar that are listening in, can you just give us an overview of Catalyst and each of your product candidates?Richard John DalyPresident, CEO & Director Sam, thanks for the opportunity to be here. We really appreciate it. Happy to go over the products and be joined by my colleagues here and to talk about the scope and span of the business. So Catalyst -- the focus of Catalyst is orphan and r ...

LENZ Therapeutics (NasdaqGS:LENZ) FY Conference December 02, 2025 03:30 PM ET Speaker0Great. Welcome everyone to the Piper Sandler Healthcare Conference. My name is Jaron Amin. I'd like to welcome our next company. We have LENZ Therapeutics and their CEO, Eef Schimmelpennink. So, welcome, Eef. Maybe to start, you know, clearly an exciting year for LENZ with FDA approval of Viz. And then, you know, the launch a few months ago. If you could maybe just talk about, you know, last eight, nine weeks, since the pr ...