Vera Therapeutics (NasdaqGM:VERA) FY 2025 Conference December 03, 2025 04:00 PM ET Company ParticipantsMarshall Fordyce - CEORobert Brenner - CMOModeratorThe CEO, Marshall Fordyce. Welcome. Thank you. And special guest, Robert Brenner, CMO. Thank you very much as well for joining us up here. So a lot to talk about. You know, you're late stage, of course, in IgAN. But maybe just set the stage and tell us where you are. Tell us about the recent data, of course, at ASN and what the timelines are for getting to ...

Vera Therapeutics (NasdaqGM:VERA) FY 2025 Conference December 03, 2025 04:00 PM ET Company ParticipantsMarshall Fordyce - CEORobert Brenner - CMOModeratorThe CEO, Marshall Fordyce. Welcome. Thank you. And special guest, Robert Brenner, CMO. Thank you very much as well for joining us up here. So a lot to talk about. You know, you're late stage, of course, in iGAN. But maybe just set the stage and tell us where you are. Tell us about the recent data, of course, at ASN and what the timelines are for getting to ...

Amylyx Pharmaceuticals (NasdaqGS:AMLX) FY 2025 Conference December 03, 2025 04:00 PM ET Company ParticipantsJustin Klee - Co-CEo and Co-FounderConference Call ParticipantsGeoff Meacham - Senior AnalystGeoff MeachamAll right. Okay, welcome to the Citi Global Healthcare Conference. I'm Jeff Meacham.Global Head of Healthcare.Global Head of Healthcare, thank you. And Senior Analyst, big cap and mid-cap biotech and pharma. Obviously, Jarvis Fang is up here with me from my team. We're thrilled to have Amylyx. So ...

Financial Data and Key Metrics Changes - The company has submitted its Biologics License Application (BLA) on November 7, with a potential PDUFA date expected in July 2026, indicating a significant milestone in its regulatory process [2][3] - The company is well-capitalized with an estimated $400 million to $500 million in resources and access to an additional $500 million, totaling approximately $1 billion for the upcoming launch year [52] Business Line Data and Key Metrics Changes - The lead product candidate, Atakicept, has shown positive phase three data in treating IgA nephropathy, with a patient population of about 160,000 in the U.S. at risk for progression to end-stage kidney disease [3][4] - The company is the only program approaching an autoinjector for Atakicept, which is expected to enhance patient convenience and adherence [4][26] Market Data and Key Metrics Changes - There are currently five drugs approved for IgA nephropathy, with Atakicept being the only one targeting B cell signaling, which is crucial for the disease's pathology [25][26] - The market for IgA nephropathy treatments is primarily composed of young patients, with approximately 75% covered by private commercial insurance [55] Company Strategy and Development Direction - The company aims to establish itself as a leader in the nephrology space, starting with IgA nephropathy and expanding to adjacent glomerular diseases such as membranous nephropathy and FSGS [36][42] - The corporate strategy includes capturing long-term data for patients treated with Atakicept and exploring additional indications beyond nephrology [21][36] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future for patients with IgA nephropathy, highlighting the unprecedented efficacy and safety profile of Atakicept compared to existing therapies [10][12] - The company is preparing for a successful launch, leveraging the experience of its leadership team from previous blockbuster drug launches [54] Other Important Information - The company has initiated a dose range finding study for Atakicept, exploring different dosing regimens to optimize treatment [48] - The guideline process in nephrology is evolving, with a strong motivation from KDIGO to update guidelines in a timely manner following new drug approvals [31][34] Q&A Session Summary Question: What is the expected PDUFA date for Atakicept? - The company expects to hear about a PDUFA date in early January, with a potential date in July 2026 [3] Question: How does Atakicept compare to other therapies in the market? - Atakicept is the only drug targeting B cell signaling, with two-year GFR data that no other approved drug has demonstrated [25][26] Question: What is the commercial strategy for launching Atakicept? - The company has a well-prepared commercial leadership team and plans to launch with an autoinjector, aiming to create awareness and excitement around the drug [28][29] Question: How will the company address the payer landscape? - The company has a clear strategy to navigate the market, understanding that the majority of patients are covered by private commercial insurance [55] Question: What are the future development plans for Atakicept? - The company plans to expand its research to include other autoimmune diseases and is currently studying various cohorts within the Pioneer protocol [36][42]

Amylyx Pharmaceuticals (NasdaqGS:AMLX) FY 2025 Conference December 03, 2025 04:00 PM ET Speaker2All right. Okay, welcome to the Citi Global Healthcare Conference. I'm Jeff Meacham.Global Head of Healthcare.Global Head of Healthcare, thank you. And Senior Analyst, big cap and mid-cap biotech and pharma. Obviously, Jarvis Fang is up here with me from my team. We're thrilled to have Amylyx. So Justin Klee is with us, co-CEO. We won't trash the other co-CEO, you know. You got the look to Miami.Yeah, yeah, yeah, ...

Sanofi (NasdaqGS:SNY) FY 2025 Conference December 03, 2025 03:15 PM ET Company ParticipantsPaul Hudson - CEOGraham Parry - Managing Director and Head of European Pharmaceuticals Equity ResearchGraham ParryThanks for joining us at the next session. I'm Graham Parry from Citi, and it's a pleasure to be able to introduce Sanofi, and in particular to introduce Paul Hudson, the CEO. It's great to have you here in Miami, Paul. I'm sure it's nothing to do with the sand and the sea that interests you here. It's pur ...

Bio-Techne (NasdaqGS:TECH) FY 2025 Conference December 03, 2025 03:15 PM ET Company ParticipantsJim Hippel - EVP and CFOConference Call ParticipantsPatrick Donnelly - Tools and Diagnostics AnalystPatrick DonnellyNext we can get going in the table.Jim HippelYeah.Patrick DonnellyAll right. We'll look to get going here. Thanks for joining us. I'm Patrick Donnelly, the tools and diagnostics analyst here at Citi. Happy to have Jim Hippel from Bio-Techne with us today. So Jim, you know, a bunch of different stuff ...

Sanofi (NasdaqGS:SNY) FY 2025 Conference December 03, 2025 03:15 PM ET Company ParticipantsPaul Hudson - CEOGraham Parry - Managing Director and Head of European Pharmaceuticals Equity ResearchGraham ParryThanks for joining us at the next session. I'm Brian Parry from Citi, and it's a pleasure to be able to introduce Sanofi, and in particular to introduce Paul Hudson, the CEO. It's great to have you here in Miami, Paul. I'm sure it's nothing to do with the sand and the sea that interests you here. It's pure ...

Bio-Techne (NasdaqGS:TECH) FY 2025 Conference December 03, 2025 03:15 PM ET Company ParticipantsJim Hippel - EVP and CFOConference Call ParticipantsPatrick Donnelly - Tools and Diagnostics AnalystPatrick DonnellyNext we can get going in the table.Jim HippelYeah.Patrick DonnellyAll right. We'll look to get going here. Thanks for joining us. I'm Patrick Donnelly, the tools and diagnostics analyst here at Citi. Happy to have Jim Hippel from Bio-Techne with us today. So Jim, you know, a bunch of different stuff ...

Financial Data and Key Metrics Changes - The company reported a significant reduction in major adverse cardiac events (MACE) by 21% in the BROADWAY trial, which included 2,500 patients, indicating strong efficacy of their drug [4][7] - The drug demonstrated a 50% reduction in Lp(a) levels, a key target for cardiovascular health, which is not addressed by statins [5][58] Business Line Data and Key Metrics Changes - The BROADWAY trial results have positioned the drug as a differentiated therapy in the lipid-lowering market, with additional benefits in diabetes risk reduction and potential Alzheimer's prevention [6][21] - The company is preparing for the PREVAIL study, which is expected to provide further validation of the drug's efficacy and safety [9][14] Market Data and Key Metrics Changes - The company anticipates a significant increase in the patient population needing aggressive LDL treatment due to new guidelines emerging from studies like VESALIUS, which showed mortality benefits from lowering LDL below 55 [54][55] - The partnership with Menarini is expected to enhance market access in Europe, leveraging their extensive sales force of 6,000 representatives [52][50] Company Strategy and Development Direction - The company aims to position its drug as the go-to option for patients requiring LDL lowering, emphasizing its unique benefits beyond traditional lipid-lowering therapies [56][57] - Future studies are planned to explore the drug's effects on Alzheimer's and diabetes, with a focus on expanding its therapeutic indications [76][78] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the drug's potential to address unmet medical needs in cardiovascular health and Alzheimer's prevention, highlighting the growing recognition of its benefits in the medical community [8][20] - The company is committed to maintaining a strong adherence to study protocols in ongoing trials, which is crucial for regulatory approval and market success [9][13] Other Important Information - The company has published significant findings in reputable journals, enhancing its credibility and visibility in the medical community [50][19] - The management is exploring partnerships for funding large-scale studies to mitigate financial risks associated with drug development [31][34] Q&A Session Summary Question: What is the expected impact of the PREVAIL study on the drug's market potential? - Management indicated that the PREVAIL study is crucial for validating the drug's efficacy and will inform the timing of regulatory filings for U.S. approval [14][15] Question: How does the company plan to address skepticism regarding CETP inhibitors? - The management acknowledged the need to address skepticism and emphasized the importance of robust data from the BROADWAY trial to build confidence among healthcare providers [78][50] Question: What are the anticipated guidelines for LDL treatment following recent studies? - Management expects that new guidelines will significantly increase the number of patients requiring treatment, particularly those with atherosclerotic disease [54][55]