Ciena (NYSE:CIEN) Q4 2025 Earnings Call December 11, 2025 08:30 AM ET Speaker4Good morning and welcome to Ciena's Fiscal Fourth Quarter and Year-End 2025 Financial Results Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing star then zero on your telephone keypad. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdra ...

Suzano (NYSE:SUZ) 2025 Investor Day December 11, 2025 08:00 AM ET Company ParticipantsCarlos Aníbal - EVP EuropeMarcio Farid - VPCaio Ribeiro - Managing DirectorMarcos Lima - CFOLuís Renato Bueno - EVP of Consumer Goods BusinessMalu Pinto - EVP of Communication and BrandCaio Greiner - Equity Research DirectorDouglas Lazaretti - EVP of ForestryFabio Almeida de Oliveira - EVP of Paper and PackagingLeonardo Grimaldi - EVPBeto Abreu - CEODaniel Sasson - Head of Latam Steel and Mining of Pulp and Paper and Cemen ...

Roivant Sciences (NasdaqGS:ROIV) 2025 Investor Day December 11, 2025 08:00 AM ET Company ParticipantsNone - Video Narrator 3Lindsay Androski - CEONone - Video Narrator 5Matt Gline - CEOUmer Raffat - Senior Managing DirectorNone - Video Narrator 9Richard Pulik - CFONone - Video Narrator 6None - Video Narrator 1None - Video Narrator 10Frank Torti - Vant ChairBen Zimmer - CEONone - Video Narrator 4Iris Gao - Equity Research Senior AssociateNone - Video Narrator 7Eric Venker - PresidentCorinne Jenkins - VPNone ...

Corbus Pharmaceuticals Holdings (NasdaqCM:CRBP) Update Summary Company Overview - **Company**: Corbus Pharmaceuticals Holdings - **Event**: Investor Webinar held on December 11, 2025 Key Points Industry and Product Focus - The discussion centers around the development of **CRB-913**, a novel **CB1 inverse agonist** aimed at treating obesity and weight-related medical complications [1][2][5] - Comparison is made with **Monlunabant**, another CB1 inverse agonist, highlighting differences in brain exclusion and safety profiles [5][6][11] Clinical Study Insights - **Study Design**: The **Single Ascending Dose (SAD)** and **Multiple Ascending Dose (MAD)** studies involved healthy volunteers and participants with obesity, focusing on safety and pharmacokinetics (PK) [6][7][8] - **Dosing**: CRB-913 was administered at doses up to **600 mg**, significantly higher than effective doses of Monlunabant [7] - **Safety Profile**: CRB-913 exhibited a favorable safety profile with minimal gastrointestinal (GI) adverse events, contrasting sharply with Monlunabant, which had a high incidence of GI issues [9][10][11] Efficacy and Weight Loss Results - Participants in the obesity cohort (average BMI of **36**) experienced weight loss of **2.9%** over **14 days**, with no weight loss in the placebo group [13][52] - Weight loss was not associated with GI adverse events, indicating a unique mechanism of action for CRB-913 [22][39] - The drug demonstrated a long half-life, contributing to sustained weight loss effects beyond the dosing period [45][46] Neuropsychiatric Safety - CRB-913 showed no significant neuropsychiatric adverse events, with validated questionnaires indicating no cases of suicidality or depression among participants [11][12][25] - Mild anxiety was reported in a few cases, but these did not trigger any significant concerns [26][27] Future Directions - Corbus Pharmaceuticals plans to initiate **CANYON-1**, a Phase 1b study focusing on safety and tolerability, with a titration approach to dosing [19][20] - The company aims to learn from Monlunabant's experiences to improve patient outcomes and safety [19][20] Market Context and Need - There is a recognized need for diverse treatment options in obesity management, as many patients do not respond adequately to existing therapies, particularly GLP-1 agonists [33][34][35] - The potential for combination therapies targeting different pathways in obesity treatment is emphasized [34][35] Conclusion - The data presented indicates that CRB-913 has a promising profile as a treatment for obesity, with early indications of efficacy and a favorable safety profile compared to existing therapies [22][39][56] - Further studies are necessary to confirm these findings and establish the drug's role in clinical practice [56][58]

Zealand Pharma Capital Markets Day Summary Company Overview - **Company**: Zealand Pharma - **Event**: 2025 Capital Markets Day - **Date**: December 11, 2025 - **Focus**: Management of obesity and metabolic health pipeline Key Industry Insights - **Obesity Market Evolution**: The obesity market has significantly evolved, with key trends reinforcing Zealand Pharma's perspectives shared two years ago [2][12] - **Healthcare Crisis**: Over 1 billion people globally are living with obesity, creating a civilization-scale problem that requires innovative solutions beyond current GLP-1-based therapies [14][15] - **Consumer Engagement**: The consumer segment is rapidly growing, with nearly two-thirds of discussions initiated by consumers, indicating a shift towards consumer-driven treatment choices [40][41] Core Company Strategies - **Pipeline Development**: Zealand Pharma aims to maximize the value of petrelintide, an amylin analog, and invest significantly in its metabolic health pipeline, increasing research investments fivefold over the next five years [22][24] - **Partnership with Roche**: A 50/50 partnership with Roche is established to co-commercialize petrelintide, combining Zealand's biotech agility with Roche's pharmaceutical strength [18][19] - **Research Expansion**: A new research hub in Boston will complement the existing Copenhagen site, focusing on AI, machine learning, and novel chemistry approaches [22][23] Product Highlights - **Petrelintide**: Described as the "crown jewel," petrelintide is designed to help individuals feel full faster and is positioned as a foundational therapy for weight management [7][17] - **Survodutide**: A dual agonist targeting GLP-1 and glucagon receptors, showing promising phase two data for weight loss and metabolic health improvements [50][56] Clinical Insights - **Weight Maintenance Focus**: Emphasis on transitioning from weight loss to weight maintenance, addressing the need for durable therapies that help maintain weight loss [16][34] - **Real-World Data**: High discontinuation rates of current therapies highlight the need for better patient experiences and alternatives to GLP-1 therapies, which often lead to gastrointestinal side effects [44][46] Future Outlook - **2030 Ambition**: Zealand Pharma's "Metabolic Frontier" ambition includes five product launches and over ten clinical candidates by 2030, aiming to establish itself as a generational biotech company [22][24] - **Transformational Potential**: The partnership with Roche and the development of innovative therapies position Zealand Pharma to redefine obesity management and address significant unmet medical needs [18][19][22] Additional Considerations - **Cultural Commitment**: Zealand Pharma emphasizes its unique culture and commitment to agility and innovation, which are seen as critical to its success in the competitive biotech landscape [11][25] - **Healthcare System Impact**: The company recognizes the broader societal implications of obesity and the need for comprehensive solutions that address the healthcare crisis associated with it [15][12]

Rhythm Pharmaceuticals Conference Call Summary Company Overview - **Company**: Rhythm Pharmaceuticals (NasdaqGM:RYTM) - **Focus**: Development of treatments for rare diseases, specifically targeting Prader-Willi syndrome (PWS) Key Points from the Conference Call Industry and Product Development - **Exploratory Phase Two Trial**: Preliminary data indicates that setmelanotide shows a positive efficacy signal in treating PWS [2][4] - **Trial Details**: Conducted as a single-center study at the University of Florida, led by Dr. Jennifer Miller [4] - **Next Steps**: Based on early data, the company plans to proceed to a Phase 3 program in PWS [4][30] Clinical Trial Results - **Patient Enrollment**: 18 patients enrolled, with a mean BMI of 39.1 [11] - **BMI Changes**: Six out of eight patients showed a decrease in BMI at three months, with reductions ranging from -1.3% to -4.8% [12] - **Long-term Goals**: Aiming for a 5% reduction in BMI at one year as a key endpoint for the Phase 3 study [5][30] Efficacy and Safety - **Positive Outcomes**: Significant changes in BMI and HQCT scores observed at three and six months [4][12] - **Patient Compliance**: High compliance noted, with most patients tolerating doses of 4 to 5 mg [17][48] - **Adverse Events**: Setmelanotide was well tolerated, with common side effects including hyperpigmentation and injection site reactions [17] Market Need and Patient Population - **Unmet Medical Need**: PWS is characterized by severe obesity and hyperphagia, with limited therapeutic options available [8] - **Prevalence**: Estimated at approximately 20,000 patients in the U.S. [8] Future Plans - **Phase 3 Trial Proposal**: Plans to submit a proposal to the FDA after completing the current trial and gathering six-month data from all patients [31] - **RM-718 Development**: Initiated a part D arm in the Phase 1 study of RM-718, a weekly MC4R agonist, to be tested in up to 20 PWS patients [5][32] Insights from Experts - **Dr. Jennifer Miller's Commentary**: Emphasized the complexity of PWS and the importance of understanding individual patient responses [18][19] - **Patient Experience**: Patients reported feeling better overall, with improved diabetes control and reduced hyperphagia [21][24] Regulatory Considerations - **FDA Expectations**: The primary endpoint for the Phase 3 trial is likely to be a change in mean BMI, with a focus on achieving a 5% reduction [34] - **Responder Analysis**: Important for regulatory approval, assessing how many patients achieve significant weight loss [34] Conclusion - **Overall Sentiment**: The early data from the trial is promising, supporting the move to Phase 3 with confidence in achieving positive outcomes [30][31] - **Next Data Release**: Full six-month data expected to be disclosed in the first half of 2026 [32] This summary encapsulates the key points discussed during the Rhythm Pharmaceuticals conference call, highlighting the company's focus on PWS, the promising trial results, and future plans for product development and regulatory submissions.

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SECOND QUARTER FY26: SUPPLEMENTAL INFORMATION 2 BUSINESS OVERVIEW & STRATEGIC ACTIONS CULP, INC. (NYSE: CULP) December 2025 FORWARD-LOOKING STATEMENTS This presentation contains "forward-looking statements" within the meaning of the federal securities laws, including the Private Securities Litigation Reform Act of 1995 (Section 27A of the Securities Act of 1933 and Section 21E of the Securities and Exchange Act of 1934). Such statements are inherently subject to risks and uncertainties that may cause actual ...

Company Overview - AC Immune is focused on precision prevention of neurodegenerative diseases, particularly Alzheimer's and Parkinson's [4] - The company has potential partnering milestones exceeding CHF 4.3 billion [4] - As of September 30, 2025, AC Immune's cash reserves were CHF 108.5 million [6], equivalent to approximately USD 136 million [4] - The company has 100.9 million shares outstanding [6] ACI-7104 Phase 2 Interim Results - The Phase 2 study of ACI-7104 included a total enrollment of 34 patients [24] - The most common adverse events (AEs) were injection site reactions (55.9%), headaches (14.7%), and fatigue (11.8%) [28] - ACI-7104 demonstrated a 100% responder rate for anti-PD012 antibody titers in serum [29] - ACI-7104 treatment showed a trend towards stabilization of disease progression, with the MDS-UPDRS Part III total score suggesting stabilization [67] Biomarker and Imaging Findings - ACI-7104 immunization stabilized total alpha-synuclein levels in cerebrospinal fluid (CSF), demonstrating target engagement [41] - Neurofilament light chain (NfL) levels in CSF remained stable in the ACI-7104 group, suggesting a potential slowing of neurodegeneration [43] - Dopamine transporter (DaT-SPECT) imaging suggested stabilization of Parkinson's disease pathology [50]