International expansion is progressing with European dossiers for the PreTRM Global test expected for submission in the coming months to secure CE marking.Operational improvements focused on clinical workflow integration, including peer-to-peer education and digital platforms to drive repeat ordering among early adopters.Strategic focus has shifted toward high preterm birth burden states, with engagement expanding from 6 to 13 states during 2025 to build local market density.Management rebranded 'Medicaid p ...

Financial Data and Key Metrics Changes - In 2025, the company achieved record revenue of $66.6 million, a nearly 20% increase over 2024, with testing volume up over 11% and trailing 12-month ASP up over 7% [21][27][29] - Gross margin for 2025 was just over 58%, down from about 60% in 2024, reflecting ASP pressure experienced in the second half of the year [23][24] - Operating expenses for 2025 were $53 million, up about 13% compared to 2024, indicating early signs of scale in the business as revenue growth outpaced expense growth [24][25] Business Line Data and Key Metrics Changes - The company reset the volume run rate from approximately 30,000 tests in Q1 to over 35,000 tests in subsequent quarters, marking the highest Q4 testing volume in Exagen's history [11][21] - ASP at the end of 2025 was approximately $441, up from $411 at the start of the year, driven by new product enhancements and improved revenue cycle management [12][22] Market Data and Key Metrics Changes - The company expanded its sales force from 40 to 45 territories in 2025, with expectations for improved productivity from new sales representatives over time [12][21] - The Pharma Services segment generated $1.7 million in revenue in 2025, significantly up from roughly $100,000 in 2024, with a backlog value of over $4 million expected to be realized over the next 2-3 years [23] Company Strategy and Development Direction - The company aims to own the entire autoimmune diagnostics space, focusing on comprehensive care and innovation to address significant unmet needs in the market [6][18] - The strategy includes advancing adoption through an upgraded sales force, expanding ASP through revenue cycle optimizations, and driving innovation with a structured product cadence [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to achieve sustainable, profitable growth, with revenue expectations for 2026 set between $70 million to $73 million [18][27] - The company is focused on creating a foundation for innovation and evaluating select inorganic opportunities to support long-term growth [19][20] Other Important Information - The company has five promising assets in development and plans to launch one product each year to expand its addressable market opportunity [15][16] - The American College of Rheumatology has begun advocating for the company's products, which is expected to drive medical policy progress with payers [14][50] Q&A Session Summary Question: Why is it the right time to make investments despite profitability targets? - Management indicated that investments in the commercial organization and R&D are necessary for durable cash flow positivity, emphasizing the importance of achieving sustainable growth [32][35] Question: What is the commercialization target for the myositis product? - The company aims to have the myositis offering ready for the clinic by 2027, with ongoing internal feasibility studies and validation of assays [36][37] Question: What is the expected ASP for Q4 2026? - Management did not disclose specific ASP figures but indicated that they expect stabilization and incremental gains in the second half of 2026 [39][40] Question: How is the Northwell Health situation affecting volume growth? - Management views the Northwell situation as a one-time setback and has seen growth initiatives compensate for any lost volume [40][41] Question: What is the status of the local coverage determination for rheumatologic disease? - The company maintains regular contact with the team at MolDX regarding the draft LCD, which is expected to cover broader testing in rheumatologic conditions [76][77] Question: What are medical directors asking about during discussions? - Medical directors are interested in understanding the clinical impact of the company's tests on patient outcomes and are looking for contemporary data to support their decisions [80][81]

Financial Data and Key Metrics Changes - The company faced significant cash flow challenges in 2025, with working capital reducing cash flow by $960 million and contributing to an $829 million increase in net debt [18] - Cash cost of conversion for phosphate improved to $112 per ton in Q4 2025, a reduction of approximately $20 per ton compared to earlier in the year [13] - The company achieved its $150 million cost savings objective ahead of schedule in 2025 [13] Business Line Data and Key Metrics Changes - Phosphate production in Q4 2025 was 1.7 million tons, with expectations to produce at least 7 million tons in 2026 [11] - Potash production is expected to reach around 9 million tons in 2026, maintaining levels similar to 2025 [11] - The company reported record mining production at Miski Mayo and strong rock production in Florida [10] Market Data and Key Metrics Changes - U.S. phosphate demand fell sharply in Q4 2025 due to affordability challenges, but there is an emerging demand as farmers prepare for spring planting [6][8] - Global potash shipments are expected to approach record levels in 2026, driven by broad-based demand across key geographies [9] - The phosphate supply and demand dynamics are supportive, with China restricting exports to prioritize domestic demand [9] Company Strategy and Development Direction - The company is focused on improving phosphate production performance and has committed to further cost reductions in 2026 [7] - Capital allocation efforts include divesting non-core assets to focus on areas that matter most [7] - The company is advancing technology-enabled initiatives to drive efficiencies and expects to deliver another $100 million in savings in 2026 [14] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about the long-term outlook despite a tough ending to 2025, citing solid global agricultural fundamentals [5][8] - The company anticipates cash flow to improve progressively throughout 2026 as working capital releases are expected [20] - Management acknowledges challenges in Brazil due to credit constraints but believes in the long-term growth potential of the market [59] Other Important Information - The company expects capital expenditures in 2026 to be around $1.5 billion, higher than 2025, due to necessary investments in mine expansions [17] - The company is pursuing strategic alternatives for selected Brazilian assets and expects to generate value through monetization of Florida land holdings [17] Q&A Session Summary Question: Can you triangulate your thoughts on phosphate pricing and farmer affordability? - Management acknowledges that affordability for farmers remains challenged but sees improvement in 2026 compared to 2025, with expectations of better pass-through on sulfur prices [27][29] Question: Can you provide a walkthrough of phosphate production expectations for 2026? - Management expects to achieve an operating factor of around 80% across key facilities, with a target of over 7 million tons of phosphate production in 2026 [34][36] Question: What triggered the increase in capital expenditures for 2026? - The increase is due to a confluence of waste disposal projects and necessary investments in multiple sites, but management is confident that expenditures will trend down in the future [46][48] Question: How is the company managing excess phosphate rock inventory? - The company built excess rock inventory due to lower consumption rates and expects to balance this out as production increases [50][51] Question: What is the outlook for Fertilizantes in Brazil? - Management anticipates a challenging year in 2026 due to credit issues but remains optimistic about long-term growth, emphasizing prudent decision-making regarding sales [58][59]

There are tremendous opportunities for Canada. And I would say to Southeast Asia, and you heard me say this before, come to Canada. I mean, you know, we're here at the Milken Institute.We're talking about capital. So much of the capital today is talking about where is it that they can actually find places for global diversification. I would say Canada is a great place because the other thing we hear from so many of the capital investors here is they're looking for predictability.They're looking for countrie ...

Core Insights - Tonix Pharmaceuticals has received FDA approval for Tonmya™, the first new therapy for fibromyalgia in over 15 years, with a U.S. launch expected in Q4 2025 [1][4]. Company Overview - Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates [2][4]. - The company focuses on central nervous system disorders, immunology, immuno-oncology, rare diseases, and infectious diseases [4]. Leadership Appointment - Ganesh Kamath has been appointed as Head of Market Access, effective September 29, 2025, bringing over 25 years of experience in market access, pricing, and commercial operations [2][3]. - Kamath's previous roles include Vice President at CuriaGlobal and CFO at Hutchmed International, where he established pricing governance frameworks and advanced market access strategies [3]. Product Details - Tonmya™ is indicated for the treatment of fibromyalgia in adults and is a first-in-class, non-opioid analgesic [4][7]. - The product is part of a broader portfolio that includes treatments for acute migraine and various CNS disorders [4]. Development Pipeline - Tonix's development pipeline includes TNX-102 SL for acute stress reaction, TNX-1500 for organ transplant rejection, TNX-2900 for Prader-Willi syndrome, and TNX-801 for mpox and smallpox [4]. - The company has a contract with the U.S. Department of Defense for TNX-4200, a broad-spectrum antiviral agent, valued at up to $34 million over five years [4].

Trade Negotiations & Tariffs - The tariff issue is expected to be settled by August 1st, with tariffs going into effect on that day [1] - While negotiations can continue after August 1st, payments based on existing tariffs will be due [1] - The US is seeking market access for American ranchers, farmers, and fishermen [2] - Tariffs, such as 26%, 27%, 31%, and 19%, will be imposed if markets are not opened to American products [2] Market Access & Pricing - Increased activity as parties present their "best offer," but the "price" for market access has significantly increased [2] - The "price" involves opening markets to American goods [2]

Trade Policy - The Trump administration anticipates Indonesia's trade barrier reduction will unlock at least $50 billion in additional market access for US goods [1]

Market Dynamics & Latency - Latency, the delay in information transmission, is paramount in modern financial markets, outweighing strategy and logic [1][2] - Traditional markets evolved from manual trades to digitized exchanges with set hourly intervals, algorithms, and methodologies governing financial market operations [2][3] - High-frequency trading firms execute tens of billions of dollars daily, emphasizing the importance of minimizing latency [8] Crypto Market Challenges & Opportunities - Crypto markets operate 24/7/365, lacking the standardized governance of traditional markets, posing challenges for institutional adoption [6][7] - The absence of standardized trading infrastructure in crypto, including collocation, normalized data feeds, and fair exchange access, hinders institutional market access [5][8][9] - Institutions with advanced, proprietary trading technologies currently dominate crypto, highlighting the need for broader access and transparency [9] - Advancing the maturity of the crypto space is critical for achieving optimal market access, better pricing for customers, and transparency [9][12] Infrastructure & Technology - Traditional firms invest in infrastructure like underground tunnels and microwave towers to reduce latency by microseconds [5] - Collocation, placing servers near exchanges, is crucial for minimizing latency and improving trading speed [8] - Standardized data feeds across exchanges and fair access across jurisdictions are essential for institutional adoption in crypto [9]