CSP (NasdaqGM:CSPI) Q4 2025 Earnings Call December 16, 2025 10:00 AM ET Speaker4Good day, everyone, and welcome to the CSPI's Fiscal Fourth Quarter and Full Year 2025 Conference Call. At this time, all participants are placed on a listen-only mode, and we will open the floor for your questions and comments after the presentation. It is now my pleasure to hand the floor over to your host, Michael Polyviou. Sir, the floor is yours.Speaker5Thank you, Matthew, and hello, everyone. Thank you for joining us to re ...

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 Core Insights - **Masdar's Withdrawal**: Masdar has officially withdrawn from the consortium, leading to the termination of discussions regarding the proposed transaction.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.

Vice President of Investor Relations Reporting Disclaimer This presentation contains, in addition to historical information, certain "forward-looking statements" (within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended), that are based on our current assumptions, expectations and projections about future performance and events and relate to, among other matters, our future financial performance, our business strategy, in ...

Financial Performance - Q3 2025 - Net loss was $10.1 million, compared to a net loss of $28.2 million in the prior year's third quarter[12] - Reported EPS loss was $0.29, with an adjusted EPS loss of $0.23, after adjusting for a tax valuation allowance of $2.0 million[12] - Adjusted EBITDA increased by $5.5 million year-over-year to ($0.7) million[12] - Inventory decreased by $39.2 million, a 17.0% reduction compared to the previous year[12] Balance Sheet and Liquidity - Cash and cash equivalents totaled $8.2 million, with net liquidity at $88.6 million[12] - Debt to Capital ratio is 22.0%[19] - The Asset Based Lending Agreement extends to 2030 and provides for borrowings of up to $125.0 million[21] Fiscal Year 2025 Outlook - Adjusted EBITDA guidance range is affirmed at the higher end, between $23 million and $25 million, compared to the previous range of $20 million to $25 million[12] - Net sales guidance is updated to a range of $555 million to $565 million, compared to the previous guidance of $570 million to $595 million[12] - Capital expenditures are affirmed at $17 million[12] Capital Expenditures Initiatives - The company is investing in capital expenditures for 15 new stores, technology roadmap, website re-platform, etc[27]

OrganiGram (NasdaqGS:OGI) Q4 2025 Earnings Call December 16, 2025 08:00 AM ET Company ParticipantsGreg Guyatt - CFOMax Schwartz - Director of Investor RelationsAaron Grey - Managing Director and Head of Consumer ResearchBrenna Cunnington - Equity Research AssociatePeter Amirault - Executive ChairTim Emberg - President of Organigram CanadaOperatorGood morning. My name is Tiffany, and I'll be your conference operator today. At this time, I'd like to welcome everyone to the Organigram Global Fourth Quarter Fis ...

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.

Financial Data and Key Metrics Changes - In Q4, net revenue increased 79% to CAD 80.1 million from CAD 44.7 million in the same prior year period [15] - Full-year fiscal 2025 net revenue increased 62% to CAD 259.2 million from CAD 159.8 million in the prior year [15] - Adjusted gross profit for Q4 increased 85% to CAD 30.6 million versus CAD 16.5 million in Q4 last year [16] - Adjusted EBITDA set a company record in fiscal 2025, with Q4 adjusted EBITDA of CAD 9.8 million, an increase of 72% sequentially and 69% year-over-year [20] - The net loss for Q4 was CAD 38 million, compared to a net loss of CAD 5.4 million in the same prior year period [22] Business Line Data and Key Metrics Changes - The acquisition of Motif Labs contributed significantly to growth without market share dilution [4] - The company achieved record international sales of CAD 26.3 million in fiscal 2025, a 171% increase versus the prior year [10] - Adjusted gross margin in Q4 rose by 400 basis points over Q3 to 38% [17] Market Data and Key Metrics Changes - Organigram holds the number one market position in Canada with 11.9% market share in fiscal 2025 [6] - The company ranked first in Ontario, British Columbia, and Alberta, and fourth in Quebec [7] - Market share in New Brunswick reached 34.2%, Newfoundland 23.7%, Saskatchewan 14.9%, and Nova Scotia 12.2% [7] Company Strategy and Development Direction - The company aims to increase the margin profile of its domestic product mix while optimizing operational footprint for capacity and throughput [9] - Plans to launch new products, including coated infused pre-rolls and beverages, to meet evolving consumer needs [9] - The focus on international expansion includes launching branded vapes and gummies in Australia [34] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued growth supported by a stronger platform and expanding international opportunities [26] - The company anticipates strong net revenue growth exceeding CAD 300 million in fiscal 2026 [24] - Management is monitoring U.S. regulatory changes that could impact the hemp-derived THC market but does not expect a material adverse economic impact [12] Other Important Information - The company received a CAD 2 million grant from Opportunities New Brunswick to support facility enhancements [6] - The Jupiter Fund currently has CAD 59 million available for deployment to leverage opportunities in markets outside of Canada [13] - The company is awaiting a determination on its EU-GMP application submitted in October 2025 [12] Q&A Session Summary Question: International growth expectations and supply-demand dynamics - Management indicated that they are starting to realize increased capacity and are well-positioned for fiscal 2026, particularly in Germany [32] Question: Gross margin expectations for fiscal 2026 - Management expects continued improvement in gross margin driven by operational improvements and synergies from the Motif acquisition [36] Question: Contribution of Motif synergies versus cultivation improvements to margin improvement - Management stated that the majority of margin improvement will come from operational improvements in cultivation rather than solely from Motif synergies [46] Question: Capital expenditure plans for the next year - Management plans to keep capital expenditures modest for fiscal 2026, expecting to spend less than CAD 10 million [47]

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.

Summary of Monte Rosa Therapeutics Conference Call Company Overview - **Company**: Monte Rosa Therapeutics (NasdaqGS:GLUE) - **Focus**: Development of MRT-2359, a GSPT-1-directed molecular glue degrader for treating metastatic castration-resistant prostate cancer (CRPC) Key Industry Insights - **Target Market**: Heavily pretreated metastatic castration-resistant prostate cancer patients, particularly those with androgen receptor (AR) mutations - **Market Opportunity**: Up to 30% of metastatic CRPC patients in later lines of therapy carry AR mutations, indicating a substantial market potential for MRT-2359 [6][25] Core Findings from Clinical Trials - **Clinical Activity**: In a small phase II expansion arm, MRT-2359 combined with enzalutamide showed a 100% PSA response rate in four patients with AR mutations, with two patients achieving PSA 90 responses and two achieving PSA 50 responses [5][17] - **Disease Control Rate**: The overall disease control rate was 64% across 14 patients, with two RECIST partial responses and several patients showing stable disease [6][18] - **Safety Profile**: The combination was well tolerated, with mild to moderate gastrointestinal adverse events being the most common, suggesting a favorable safety profile compared to other therapies [6][17] Mechanism of Action - **MRT-2359 Mechanism**: Acts as a molecular glue degrader of GSPT-1, leading to the degradation of MYC and other oncoproteins, which is critical for the growth of prostate cancer cells [7][9] - **Preclinical Evidence**: Prostate cancer cell lines with high MYC expression showed greater sensitivity to MRT-2359, supporting its therapeutic rationale [10][11] Future Directions - **Next Steps**: Plans to initiate a signal-confirming phase II study in 2026, focusing on AR mutant patients and potentially expanding to earlier line settings [24][25] - **Study Design**: The upcoming study will utilize a Simon's two-stage design, enrolling up to 25 patients with metastatic CRPC and AR mutations, with endpoints including PSA response and safety [24] Pipeline Updates - **Other Programs**: Progress on MRT-6160, a VAV1-directed MGD program licensed to Novartis, and MRT-8102, a NEK7-directed MGD, with plans for multiple phase II studies in immune-mediated diseases and cardiovascular conditions, respectively [26][27] Additional Insights - **Comparative Analysis**: The PSA response rate of 29% in the overall population is comparable to other combination therapies, indicating competitive positioning in the market [17][25] - **Patient Demographics**: The study population was heavily pretreated, with 75% having prior treatment with second-generation AR inhibitors and 80% with chemotherapy, highlighting the challenging nature of the patient cohort [16][18] Conclusion - **Encouraging Data**: The results from the phase I-II study of MRT-2359 demonstrate compelling clinical activity in a high unmet need population, with plans for further studies to confirm its efficacy and safety in treating metastatic CRPC [25][26]

Clinical Trial Results of MRT-2359 - MRT-2359 combined with enzalutamide demonstrated a 100% PSA response rate in heavily pre-treated mCRPC patients with AR mutations[5, 38, 59] - Among the 4 patients with AR mutations, 2 patients showed PSA90 responses and 2 patients showed PSA50 responses[5, 38] - Two patients with AR mutations achieved RECIST partial responses (1 confirmed, 1 unconfirmed), and two had stable disease, resulting in a 100% disease control rate in the AR mutant population[5] - An overall disease control rate (DCR) of 64% was observed in 14 evaluable patients, including 5 patients without AR mutations who had stable disease[5, 59] Safety and Tolerability - The combination of MRT-2359 and enzalutamide was well-tolerated, with the most frequent adverse events (AEs) being mild or moderate manageable GI symptoms[5, 33, 59] - Treatment-related AEs occurring in >15% patients included fatigue (50%), diarrhea (45%), nausea (35%), arthralgia (30%), decreased appetite (30%), vomiting (30%), neutropenia (25%), and muscular weakness (20%)[31, 32] Future Plans - The company plans to initiate a signal-confirming 2-stage Phase 2 study (MODeFIRe-1) of MRT-2359 in combination with a 2nd generation AR inhibitor in 2026, targeting AR-mutated mCRPC[2, 56, 59] - Updated data from the Phase 1/2 study is expected to be presented at the ASCO Genitourinary Cancers Symposium in February 2026[59]