Cytokinetics Conference Call Summary Company Overview - **Company**: Cytokinetics - **Product**: Micorzo (Aficamten) - **Indication**: Treatment of symptomatic obstructive hypertrophic cardiomyopathy (OHCM) Key Points FDA Approval - The FDA approved Micorzo for adults with symptomatic obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms, marking Cytokinetics' first approved medicine [4][30] - The approval is a significant milestone for the OHCM community, addressing a high unmet need [4][5] Clinical Data - Micorzo is an allosteric and reversible inhibitor of cardiac myosin motor activity, designed to reduce cardiac contractility and left ventricular outflow tract obstruction [9][10] - The approval is based on the SEQUOIA-HCM phase 3 clinical trial, which demonstrated significant improvements in exercise capacity (peak VO2 increased by 1.7 mL/kg/min compared to placebo, p-value of 0.000002) and symptom burden [10][11] - 49% of patients achieved an LVOT gradient of less than 30 mmHg compared to 4% on placebo, and there was an 80% reduction in NT-proBNP, a biomarker of cardiac wall stress [11] Safety Profile - Micorzo was well tolerated, with treatment-emergent serious adverse events occurring in 5.6% of patients on Micorzo versus 9.3% on placebo [11] - Hypertension was the only adverse reaction occurring in more than 5% of patients, with 8% on Micorzo compared to 2% on placebo [12] REMS Program - A Risk Evaluation and Mitigation Strategy (REMS) is in place to ensure safe use and monitoring for the risk of heart failure due to systolic dysfunction [16] - The REMS includes prescriber certification, patient enrollment, and echo monitoring requirements, but does not require monitoring for drug-drug interactions [16][17] Commercial Launch Plans - Cytokinetics plans to launch Micorzo in the U.S. in January 2026, with a focus on achieving over 50% preference share in the cardiac myosin inhibitor category [20][21] - The company has developed a patient support program called "Micorzo and You," which includes assistance with insurance coverage, a free trial offering, and a copay savings program [25][26] - Engagement with payers has been ongoing, with plans to secure access and coverage consistent with clinical evidence by the second half of 2026 [26] Market Opportunity - There are approximately 700,000 to 1.1 million patients living with HCM in the U.S., with obstructive HCM representing over 50% of cases [20] - The market for HCM diagnosis is expected to grow due to increased awareness and genetic testing [20] Future Developments - Cytokinetics plans to submit for an expanded label based on MAPLE data early in 2026, which may influence prescribing practices and guidelines [72][74] - The company aims to build a global franchise of cardiac muscle modulators, not only within HCM but also in adjacent indications [30] Additional Insights - The flexibility in echo monitoring and the absence of drug-drug interaction warnings are expected to facilitate broader use of Micorzo among physicians [111] - The company anticipates that the REMS will streamline the prescribing process and enhance patient access to treatment [88] This summary encapsulates the critical aspects of Cytokinetics' conference call regarding the FDA approval of Micorzo, its clinical data, safety profile, commercial strategies, and future plans in the context of the HCM market.

Financial Data and Key Metrics Changes - For fiscal year 2025, the company reported total net sales of $19.1 million, a slight decrease from $19.5 million in the prior year [16][20] - The operating loss for fiscal 2025 was approximately $2.1 million, improved from a loss of $3.3 million in 2024 [6][23] - Adjusted non-GAAP EBITDA improved from a loss of $1.7 million in 2024 to a loss of $900,000 in 2025 [6][25] - Gross profit margin for the fourth quarter of fiscal 2025 was 59%, up from 54% in the prior year [21] Business Line Data and Key Metrics Changes - E-commerce direct-to-consumer sales for the fourth quarter of fiscal 2025 were $3.5 million, a 6% year-over-year decrease [16][17] - The wholesale business generated $1.2 million in net sales for the fourth quarter of fiscal 2025, a 25% increase compared to $900,000 in the same quarter of fiscal 2024 [19][20] - For fiscal year 2025, the wholesale business generated net sales of $4.5 million, up from $3.8 million in 2024 [20] Market Data and Key Metrics Changes - Distribution for the new beverage brand, Oasis, has expanded to nine states, with improving case sell-through and growing distributor engagement [7][8] - E-commerce represented 77% of total net sales for fiscal year 2025, down from 81% in the prior year [17] Company Strategy and Development Direction - The company is focused on scaling the Oasis brand responsibly while driving efficient, profitable direct-to-consumer growth [29] - The strategy includes preserving margins and capital discipline while evaluating strategic opportunities aligned with regulatory strength [29] - The company aims to capitalize on the evolving regulatory environment, particularly with the recent executive order from the White House [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's position in the evolving regulatory landscape, highlighting the potential for increased demand for CBD products [12][30] - The company believes that the heavy lifting of the turnaround is largely behind them, with fiscal 2026 focused on improving financial performance [30] - Management noted that the executive order could lead to significant demand for quality CBD products, particularly among Medicare consumers [46] Other Important Information - The company eliminated over $7 million in annual accrued preferred dividend obligations, significantly improving working capital [9][26] - The company has a strong liquidity position entering calendar 2026, with cash and cash equivalents of approximately $2.2 million [26][28] - The NYSE American confirmed that all prior compliance deficiencies had been resolved, reflecting progress in financial stability [11] Q&A Session Summary Question: What will be the key driver of growth in 2026? - Management believes there are growth opportunities in both the core cbdMD brand and the beverage side, with visibility on growth through November [35] Question: Can you explain the decline in direct-to-consumer business? - Management indicated that the decline is tied to organizational changes and is trending slightly up over prior year periods [36][37] Question: What is the timeline for Medicare coverage of CBD products? - Management mentioned that a pilot program is expected to start on April 1st, with potential for significant demand increase [39][40] Question: How will the executive order impact the business? - Management views the executive order as a potential game changer, with significant demand for CBD products expected in the coming years [45][46] Question: How are you prioritizing growth investments for fiscal 2026? - Management indicated that the next quarter will likely see more investment in the Oasis side, with ongoing evaluations based on regulatory developments [66]

Financial Data and Key Metrics Changes - For fiscal year 2025, the company reported total net sales of $19.1 million, a decrease from $19.5 million in the prior year, representing a 2% decline [16] - The operating loss for fiscal 2025 was approximately $2.1 million, improved from a loss of $3.3 million in 2024, marking the third consecutive year of reduced operating losses [6][23] - Adjusted non-GAAP EBITDA improved from a loss of $1.7 million in 2024 to a loss of $900,000 in 2025, driven by cost control and efficient marketing [6][25] - Gross profit margin for the fourth quarter of fiscal 2025 was 59%, up from 54% in the prior year, while the full fiscal year gross margin was 63% compared to 62% in 2024 [21] Business Line Data and Key Metrics Changes - E-commerce direct-to-consumer sales for the fourth quarter of fiscal 2025 were $3.5 million, a 6% decrease year-over-year, and represented 75.1% of total net sales for that quarter [16][17] - The wholesale business generated $1.2 million in net sales for the fourth quarter of fiscal 2025, a 25% increase from $900,000 in the same quarter of fiscal 2024 [19] - For the fiscal year, wholesale sales increased from $3.8 million in 2024 to $4.5 million in 2025 [20] Market Data and Key Metrics Changes - Distribution for the new beverage brand, Oasis, expanded to nine states, with improving case sell-through and growing distributor engagement [7] - The company is positioned in the functional alcohol alternative beverage segment, which is experiencing rapid growth due to changing consumer preferences [7] Company Strategy and Development Direction - The company is focused on scaling the Oasis brand responsibly while driving profitable growth through disciplined marketing execution [29] - A significant emphasis is placed on maintaining a strong balance sheet and capital discipline while evaluating strategic opportunities [29] - The company aims to capitalize on evolving regulatory environments and consumer demand for quality CBD products [14][30] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's improved financial position and the potential for significant demand growth due to recent regulatory changes [12][30] - The executive order from the White House is seen as a positive signal for the hemp and CBD industry, potentially leading to increased consumer access and reimbursement pathways [12][13] - The company believes it is well-positioned to benefit from regulatory clarity and is focused on maintaining compliance and quality [14] Other Important Information - The company successfully eliminated over $7 million in annual accrued preferred dividend obligations, significantly improving working capital [9][27] - As of September 30, 2025, the company had cash and cash equivalents of approximately $2.2 million and working capital of approximately $3.3 million, a significant improvement from the previous year [26][27] Q&A Session Summary Question: What will be the key driver of growth in 2026? - Management indicated that both the core cbdMD brand and the Oasis beverage brand have significant growth opportunities, with a focus on the beverage side due to market visibility [34][35] Question: Can you explain the decline in direct-to-consumer sales? - Management noted that the decline is partly due to SKU rationalization and organizational changes, but overall trends are showing slight improvement [36][37] Question: What is the timeline for Medicare coverage of CBD products? - Management mentioned that a pilot program is expected to start on April 1st, with potential for significant demand growth in the coming years [38][39] Question: How will the executive order impact the business? - Management believes the executive order could lead to a substantial increase in demand for CBD products, estimating a potential $30 billion market opportunity [44][46] Question: How will the company prioritize growth investments in 2026? - Management indicated that the focus for the next quarter will lean more towards the Oasis brand, with ongoing evaluations based on regulatory developments [65][66]

Financial Data and Key Metrics Changes - For fiscal year 2025, the company reduced its operating loss by $1.2 million to approximately $2.1 million, marking the third consecutive year of improved operating results [4] - Adjusted non-GAAP EBITDA improved from a $1.7 million loss in 2024 to a $900,000 loss in 2025, driven by disciplined cost control and efficient marketing spend [4][15] - Total net sales for fiscal year 2025 were $19.1 million, a slight decrease from $19.5 million in the prior year [10] - Gross profit as a percentage of net sales increased to 63% for fiscal 2025, compared to 62% in the previous year [12] Business Line Data and Key Metrics Changes - E-commerce direct-to-consumer sales for the fourth quarter of fiscal 2025 were $3.5 million, a 6% year-over-year decrease, representing 75.1% of total net sales for that quarter [10] - The wholesale business generated $1.2 million in net sales for the fourth quarter of fiscal 2025, up 25% from $900,000 in the same quarter of fiscal 2024 [11] - The company focused on SKU rationalization and prioritizing higher velocity products across its core brands, which helped stabilize the business while maintaining strong gross margins [5] Market Data and Key Metrics Changes - The company has distribution across nine states for its new beverage brand, Oasis, and is evaluating additional markets [4] - The executive order from the White House regarding federal cannabis policy is expected to positively impact the hemp and CBD industry, potentially increasing demand for quality products [8][30] Company Strategy and Development Direction - The company is focused on scaling the Oasis brand responsibly while driving efficient, profitable direct-to-consumer growth through disciplined marketing execution [17] - The management aims to preserve margins and capital discipline while evaluating strategic opportunities aligned with regulatory strength [17] - The company believes it is well-positioned to benefit from improving regulatory clarity and is committed to maintaining a strong, flexible balance sheet [9][16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's direction, highlighting lower operating losses and restored exchange compliance as key achievements [3][17] - The potential for significant demand increase due to Medicare reimbursement pathways for CBD products was noted, with estimates suggesting a $30 billion market opportunity [17][30] - The management emphasized the importance of navigating regulatory changes carefully while continuing to build a profitable long-term organization [30][44] Other Important Information - The company received confirmation from the NYSE American that all prior compliance deficiencies had been resolved, reflecting progress in restoring financial stability [7] - The company closed $2.25 million in additional financing, enhancing its liquidity position [5][16] Q&A Session Summary Question: What will be the key driver of growth in 2026? - Management indicated that both the core cbdMD brand and the Oasis beverage line have significant growth opportunities, with a focus on regulatory developments [20][22] Question: What caused the decline in direct-to-consumer sales? - Management explained that the decline was tied to organizational changes and SKU reductions, but noted a slight upward trend in the D2C business over the past 24 months [23][24] Question: What is the timeline for Medicare coverage of CBD products? - Management mentioned that a pilot program is expected to start on April 1st, with potential for significant demand increase for quality products [25][30] Question: How will the executive order impact the business? - Management believes the executive order could lead to a substantial increase in demand for CBD products, although the details of implementation are still being assessed [29][30] Question: How will the company prioritize growth investments in 2026? - Management indicated that for the next quarter, investment will be more weighted towards the Oasis side, with ongoing evaluations based on regulatory developments [46][48] Question: What is the current share count and any new executive compensation plans? - Management provided the current share count and mentioned that a new employee compensation plan is subject to shareholder vote in the upcoming annual meeting [49][52]

Summary of BigBear.ai's Extraordinary General Meeting Company Overview - **Company**: BigBear.ai Holdings (NYSE: BBAI) - **Meeting Date**: December 19, 2025 - **Meeting Type**: Reconvened special meeting of stockholders Key Points - **Meeting Purpose**: The meeting was a continuation of a special meeting convened on December 5, 2025, to solicit additional votes on Proposal 1, which aims to amend the Certificate of Incorporation [1] - **Proposal 1**: The proposal seeks to increase the number of authorized shares of common stock. However, it did not receive the required affirmative vote of more than 50% of the outstanding shares entitled to vote as of the record date [3] - **Adjournment**: Due to insufficient votes, the meeting has been adjourned to December 30, 2025, at 3:00 P.M. Eastern Time, to allow more time for stockholders to vote on Proposal 1 [3] - **Voting Instructions**: Stockholders were reminded to refer to their proxy card or the Proxy Statement for specific voting instructions. Those holding shares in Street name were advised to check materials from their bank or broker [4] Additional Important Information - **Inspector of Elections**: Mr. Vito Cerone from Continental Stock Transfer and Trust Company was appointed as the inspector of elections for the meeting [2] - **Poll Opening**: The polls opened at 2:45 P.M. Eastern Time on the day of the meeting and remained open until the conclusion of the proposal presentation [2] - **Record Date**: The Board of Directors set October 14, 2025, as the record date for stockholders entitled to vote at this meeting [2]

Financial Data and Key Metrics Changes - The meeting reported that 11,245,414 shares of the company's stock were represented, constituting 33.97% of the voting power [4]. Business Line Data and Key Metrics Changes - No specific business line data or key metrics were discussed during the meeting [2][3]. Market Data and Key Metrics Changes - No specific market data or key metrics were provided during the meeting [2][3]. Company Strategy and Development Direction and Industry Competition - The meeting focused on the election of directors, indicating a stable governance structure, but did not elaborate on specific strategic initiatives or competitive positioning [10][11]. Management's Comments on Operating Environment and Future Outlook - Management did not provide detailed comments on the operating environment or future outlook during this meeting [2][3]. Other Important Information - The final voting results will be announced on a Form 8-K in the coming days, indicating transparency in governance [13]. Q&A Session All Questions and Answers - No questions were raised during the meeting, and thus no answers were provided [10][11].

Financial Data and Key Metrics Changes - The meeting reported that 11,245,414 shares of the company's stock were represented, constituting 33.97% of the voting power [4]. Business Line Data and Key Metrics Changes - No specific data on business lines or key metrics was provided in the meeting [2][3]. Market Data and Key Metrics Changes - No specific market data or key metrics were discussed during the meeting [2][3]. Company Strategy and Development Direction and Industry Competition - The meeting focused on the election of directors and did not provide insights into the company's strategic direction or competitive landscape [2][3]. Management's Comments on Operating Environment and Future Outlook - Management did not provide comments on the operating environment or future outlook during this meeting [2][3]. Other Important Information - The final voting results will be announced on a Form 8-K in the coming days [13]. Q&A Session All Questions and Answers - No questions were raised during the meeting [10].

Financial Data and Key Metrics Changes - The meeting reported that 11,245,414 shares of the company's stock were represented, constituting 33.97% of the voting power [4][10] - The voting results for the election of directors showed that each nominee received a plurality of votes, indicating strong support from shareholders [10] Business Line Data and Key Metrics Changes - No specific data on business lines or key metrics changes were provided in the meeting [0] Market Data and Key Metrics Changes - No specific market data or key metrics changes were discussed during the meeting [0] Company Strategy and Development Direction and Industry Competition - The meeting focused on the election of directors, with no detailed discussion on company strategy or industry competition [0] Management's Comments on Operating Environment and Future Outlook - Management did not provide specific comments on the operating environment or future outlook during this meeting [0] Other Important Information - The final voting results will be announced on a Form 8-K in the coming days, indicating transparency in the election process [12] Q&A Session All Questions and Answers - No questions were raised during the meeting, and thus no answers were provided [0]

Financial Data and Key Metrics Changes - The meeting confirmed that a quorum was present with 46,569,446 ordinary shares outstanding and eligible to vote, indicating strong shareholder engagement [5][6]. Business Line Data and Key Metrics Changes - The meeting included the approval of executive compensation for named executive officers, reflecting the company's commitment to aligning management incentives with shareholder interests [11][14]. Market Data and Key Metrics Changes - No specific market data or key metrics changes were discussed during the meeting. Company Strategy and Development Direction and Industry Competition - The company is focused on maintaining strong governance through the election of Class C directors, which is essential for strategic oversight and long-term planning [6][9]. Management's Comments on Operating Environment and Future Outlook - Management did not provide specific comments on the operating environment or future outlook during this meeting. Other Important Information - The company will hold an advisory shareholder vote on executive compensation every three years, indicating a structured approach to governance and accountability [15][18]. Q&A Session Summary - There were no questions raised during the meeting, and representatives from PricewaterhouseCoopers were available to respond to any appropriate questions after the meeting [19].

Financial Data and Key Metrics Changes - Second quarter net sales increased by 1%, with a $24 million benefit from foreign currency translation, while on a constant currency basis, net sales were essentially flat compared to last year [14] - Volume rose by 8% in the second quarter, driven by customer wins and share gains, despite softer restaurant traffic [14] - Adjusted EBITDA declined by $9 million year-over-year to $286 million, primarily due to unfavorable Price/Mix [17] - Adjusted Gross Profit decreased by $16 million year-over-year, mainly due to unfavorable Price/Mix [17] - Free cash flow was strong at $375 million, with capital expenditures down to $156 million in the first half, reflecting disciplined investment [22][23] Business Line Data and Key Metrics Changes - North America segment net sales were essentially flat compared to the prior year, with volume increasing by 8% supported by recent customer contract wins [15] - International segment net sales increased by 4%, including a favorable foreign currency impact of $23 million, but declined by 1% on a constant currency basis [15][16] - Adjusted EBITDA in the North America segment increased by 7% to $288 million, reflecting strong execution and higher sales volume [20] - Adjusted EBITDA in the International segment declined by $21 million to $27 million, impacted by price and trade to support customers and higher manufacturing costs [20] Market Data and Key Metrics Changes - In North America, QSR traffic was flat, with QSR chicken growing while QSR burger traffic was down by 3% [14] - Internationally, restaurant traffic in most markets declined, including a 3% decrease in the U.K., the largest international market [14] - Asia, including China, led volume growth in the quarter, with growth also seen with multinational chain customers [16] Company Strategy and Development Direction - The company is executing its "Focus to Win" strategy, focusing on strengthening customer partnerships and driving cost savings [4][7] - The company is reopening previously curtailed capacity in North America to meet customer demand and maintain high fill rates [4][9] - The company is building a culture of continuous improvement and reducing volatility through customer contracting and raw procurement strategies [5][6] - The company is investing in innovation, including the launch of new products like Snap Fries, to capture additional market opportunities [12] Management's Comments on Operating Environment and Future Outlook - Management acknowledged a dynamic macroeconomic and competitive environment, particularly in international markets, but expressed confidence in long-term profitable growth [6][24] - The company expects continued volume growth and strong sales momentum for the remainder of the fiscal year, particularly in North America [24] - Price/Mix is anticipated to remain unfavorable in the second half, but to a lesser extent than in the first half [24][25] - Management remains committed to returning cash to shareholders, with a 3% increase in the quarterly dividend [7][23] Other Important Information - The company ended the quarter with approximately $1.43 billion of liquidity, including $1.35 billion available under its revolving credit facility [22] - The company has repurchased $40 million of shares during the second quarter and has $308 million remaining under its current repurchase authorization [23] Q&A Session Summary Question: Regarding rebalancing supply and demand in Europe - Management confirmed that they are curtailing a single line in the European market while reopening curtailed lines in North America due to strong volume [33] Question: On North America volume drivers and seasonal uptick - Management indicated that the mix shift towards private label and multinational chain customers will continue to affect gross margins in the back half of the year [36] Question: Update on Asia export markets and competition - Management acknowledged increased competition in Asia but expressed confidence in future growth due to strong customer support [42] Question: Clarification on gross margin expectations for the second half - Management confirmed that gross margins are expected to be flat to down in the second half, primarily due to mix shifts and ramp-up costs in Argentina [46] Question: Impact of reopening capacity in North America - Management stated that reopening additional capacity is necessary to meet customer expectations and will not negatively impact profitability [57] Question: Capital allocation and share repurchases - Management reiterated their commitment to capital allocation priorities, including opportunistic share repurchases while investing in the business [110]