Tantalus Systems Holding (OTCPK:TGMP.F) Update / Briefing December 16, 2025 04:00 PM ET Company ParticipantsNone - Company Representative 2None - Company Representative 1None - Company Representative 3NoneThat safety situation in hand and alleviate that problem. But what a remote disconnect allows us to do is it allows us to have power to every customer. So you can put someone on a prepay program. So even if a customer can't afford electricity, you can set them up to be successful using our meters in a prep ...

Alvotech (NasdaqGM:ALVO) Update / Briefing December 16, 2025 12:00 PM ET Company ParticipantsLinda Jónsdóttir - CFORobert Wessman - Founder and Chairman of the BoardJoseph McClellan - COOOperatorDon't stop there. The COO, Joseph McClellan, and the Head of Investor Relations, which is Patrik Ling. There is one page in the presentation with the convertible bond terms. We can go through that afterwards. There must also be a Q&A session, and you can write your questions into the box on the top there. But now I ...

Affirm (NasdaqGS:AFRM) Fireside Chat December 16, 2025 12:00 PM ET Company ParticipantsRob O'Hare - CFOConference Call ParticipantsMatt Cotes - AnalystMatt CotesEverybody, trickle in here for a second before we start. Okay, awesome, so my name's Matt Cotes. I work at Truist Securities, covering Payments and Fintech, and I'm really pleased to be joined by Rob O'Hare here. Rob has been with the firm for a little bit over five years now, and he's been in his current seat as CFO for a little bit over one year. ...

Neurocrine Biosciences (NasdaqGS:NBIX) 2025 R&D Day December 16, 2025 12:00 PM ET Speaker0Good morning and good afternoon. My name is Todd Tushla. I'm the Vice President of Investor Relations at Neurocrine Biosciences, and on behalf of our entire company, welcome to our 2025 R&D Day. Whether you're here in person, on the webcast, or reading the transcript, we're grateful for your time. We will be making forward-looking statements today to refer you to our latest SEC disclosures. Our speakers for today from ...

Sanofi (NasdaqGS:SNY) Update / Briefing December 16, 2025 11:15 AM ET Company ParticipantsLouisa Hector - Head of Global Pharma Equity ResearchThomas Kudsk Larsen - Head of Investor RelationsSachin Jain - VPSarita Kapila - Co-Head European Pharmaceuticals Equity ResearchSimon Baker - Head of Global Biopharma ResearchNone - Company RepresentativeJames Quigley - Executive DirectorGraham Parry - Managing Director and Head of European Pharmaceuticals Biotechnology Equity ResearchJean-François Toussaint - Global ...

Vivos Therapeutics (NasdaqCM:VVOS) Fireside Chat December 16, 2025 11:00 AM ET Company ParticipantsR. Kirk Huntsman - CEOBrad Amman - CFOModeratorLet me start. As the year draws to a close, 2025 stands out as one of the most pivotal in the company's history. It marked the launch of a potentially transformative shift in Vivos' business model, highlighted by the June acquisition of the Sleep Center of Nevada, or SCN. Before we get into the operational progress of the transition, Kirk, could you start by shari ...

Artemis Gold (OTCPK:ARGT.F) Update / Briefing December 16, 2025 11:00 AM ET Company ParticipantsJeremy Langford - PresidentSteven Dean - Executive ChairMeghan Brown - VP of Investor RelationsDale Andres - CEOConference Call ParticipantsHarrison Reynolds - AnalystAndrew Mikitchook - AnalystPierre Vaillancourt - AnalystJeremy Hoy - AnalystMeghan BrownThank you, Operator, and good morning, everyone. Thank you for joining our conference call and webcast following yesterday's announcement of our expanded Phase 2 ...

Summary of ReNew Energy Global Conference Call Company Overview - **Company**: ReNew Energy Global (NasdaqGS:RNW) - **Date of Call**: December 16, 2025 Key Points Industry Context - The call addressed the recent developments regarding a consortium involving ReNew Energy and its potential acquisition discussions, particularly focusing on the withdrawal of Masdar from the consortium [4][5]. Core Insights - **Masdar's Withdrawal**: Masdar has officially withdrawn from the consortium, leading to the termination of discussions regarding the proposed transaction. This decision was unexpected and disappointing for ReNew, especially after a year of negotiations and due diligence [4][5][12]. - **Shareholder Confidence**: Despite Masdar's exit, major shareholders CPPIB and ADIA have reaffirmed their confidence in ReNew's business and growth prospects. The company remains committed to delivering value for all shareholders [5][6]. - **Financial Position**: ReNew maintains a robust liquidity position with over $1 billion in cash. The company’s portfolio is fully funded through internal cash flows and capital recycling [6][7]. - **Growth Guidance**: ReNew has reaffirmed its megawatt and EBITDA guidance for the year, indicating continued business growth and a decline in leverage [7][8]. Strategic Considerations - **Future Plans**: The board is evaluating options for realizing value from various parts of the business and will develop a plan moving forward. The leadership team is prepared for alternative strategies following the consortium's dissolution [15][16]. - **Capital Allocation**: The management is considering various strategic options, including potential share repurchases, although no immediate discussions are underway regarding new offers from other shareholders [14][22]. - **Funding and Growth Strategy**: ReNew plans to continue its growth trajectory, targeting an annual capacity of 2 to 3 GW. Funding will come from internal growth and capital recycling, with no reliance on external capital infusion from the failed transaction [32][41]. Market Reaction - Following the announcement of Masdar's withdrawal, there was a notable decline in ReNew's share price. Management expressed confidence that the market will eventually recognize the company's true value [18][52]. Additional Insights - **Operational Performance**: The company is meeting all operational deliverables for the year and does not foresee issues in raising external funding for its current pipeline [16][46]. - **Long-term Strategy**: The board emphasizes the importance of execution in a rapidly growing market and maintains confidence in the management team to deliver long-term shareholder value [51][52]. Conclusion ReNew Energy Global is navigating a challenging situation following the withdrawal of a key consortium member. However, the company remains financially strong and committed to its growth strategy, with plans to communicate further updates to shareholders in the coming months.

Summary of Aldeyra Therapeutics Regulatory Update Conference Call Company Overview - **Company**: Aldeyra Therapeutics (NasdaqCM:ALDX) - **Focus**: Development of reproxalap for the treatment of dry eye disease Key Points Regulatory Update - **PDUFA Extension**: The FDA has extended the PDUFA target action date for the new drug application (NDA) of reproxalap, originally set for December 16, 2025, due to the request for additional clinical study reports (CSR) [2][8][10] - **NDA Resubmission**: The NDA for reproxalap was resubmitted on June 16, 2025, and accepted by the FDA as a complete Class II response on July 16, 2025 [6] - **Field Trial Results**: A field trial supportive of reproxalap did not meet its primary endpoint of reducing symptoms compared to the vehicle, which led to the FDA's request for the CSR to be included in the NDA [7][9] FDA Interactions - **Communication with FDA**: Aldeyra has had limited direct communication with the FDA's Office of Specialty Medicine, focusing primarily on the Division of Ophthalmology [5] - **Labeling Discussions**: A draft label was sent by the FDA to Aldeyra in early December, and Aldeyra has provided comments on it [9][32] - **Next Steps**: If no major deficiencies are identified during the extended review, labeling requests and potential post-marketing requirements will be communicated by February 16, 2026 [10] Commercialization and Agreements - **AbbVie Option Agreement**: AbbVie has 10 business days to exercise its option following the approval of the NDA, with no changes to the terms due to the extension [18][27] - **Commercialization Timeline**: The launch date for reproxalap will depend on FDA approval, with expectations that it could occur within one to two quarters post-approval [21] Additional Insights - **FDA Guidance**: There was a discussion regarding the standard practice of submitting all CSRs with an NDA, which was initially agreed upon to be limited to the chamber trial only [14][15] - **Safety Data Requests**: The request for safety data from the field trial is considered standard during NDA reviews [25] - **Director Changes**: The director of the Office of Specialty Medicine retired, which may have influenced the recent request for the CSR submission [13] Conclusion The call provided detailed insights into the regulatory status of reproxalap, the implications of the FDA's extension of the PDUFA date, and the company's ongoing interactions with the FDA. The potential for commercialization remains contingent on the outcome of the extended review process.

Summary of Pfizer's 2026 Financial Guidance Call Company Overview - **Company**: Pfizer - **Event**: Analyst and investor call to review full year 2026 financial guidance Key Points Financial Performance and Guidance - Pfizer reaffirmed its full year 2025 adjusted diluted EPS guidance and revised revenue guidance to approximately **$62 billion** for 2025, which is within the previous range [5][16] - For 2026, total revenues are expected to be in the range of **$59.5 billion to $62.5 billion** [17] - COVID-19 product revenues are projected to decline to approximately **$5 billion** in 2026, down from **$6.5 billion** in 2025, reflecting a **40% decline** year-over-year [16][18] - Adjusted diluted EPS for 2026 is anticipated to be in the range of **$2.80 to $3.00** [19] Strategic Initiatives - Pfizer has entered a landmark voluntary agreement with the U.S. Government to lower prescription drug costs, providing clarity on pricing and tariffs [6][35] - The company is focusing on expanding its obesity portfolio, with plans to advance about **15 programs** in 2026, many of which will be in phase 3 studies [7][51] - Pfizer's oncology pipeline remains strong, with recent FDA approvals and ongoing studies expected to enhance its market position [9][10] Cost Management and Efficiency - Pfizer is on track to achieve approximately **$7.2 billion** in total combined net cost savings by the end of 2026, one year ahead of schedule [11][23] - Adjusted SI&A and R&D expenses for 2026 are expected to be in the range of **$23 billion to $25 billion**, with a focus on maintaining productivity and efficiency [20][21] Market Dynamics and Challenges - The company anticipates facing significant headwinds from loss of exclusivity (LOE) for several major brands, with approximately **$17 billion** in revenues impacted by patent expirations expected between 2026 and 2028 [26] - Pfizer is committed to maintaining its dividend while prioritizing investments in business development to ensure long-term growth [85] Future Outlook - Pfizer expects to return to growth by the end of the decade, driven by the maturation of its R&D pipeline and the performance of recently launched products [26][68] - The company is optimistic about the potential for growth in 2029 and 2030, with a focus on maximizing the potential of its pipeline and acquisitions [48][69] Additional Insights - The new organization for global hospital and biosimilars products aims to enhance productivity and streamline operations [25][80] - Pfizer's commitment to vaccines remains strong, despite current market challenges, as they are viewed as essential for public health [59] Conclusion Pfizer's 2026 financial guidance reflects a strategic focus on managing costs, expanding its product portfolio, and navigating the challenges posed by LOEs and market dynamics. The company is positioning itself for future growth while maintaining a commitment to shareholder value through dividends and strategic investments.