Company Overview - Crinetics Pharmaceuticals, Inc. is a clinical-stage biotechnology company focused on developing oral therapies for rare endocrine disorders and endocrine-related tumors [6] - The company has a market capitalization of $3.97 billion and reported a revenue of $7.7 million for the trailing twelve months (TTM) [4] - Crinetics has a net income of -$465.32 million for the TTM, indicating ongoing investment in research and development [4] Recent Developments - Rogerio Vivaldi Coelho, a director at Crinetics, sold 5,000 shares of common stock on March 12, 2026, for approximately $181,000, which represents 23.47% of his direct common stock holdings [1][2][7] - The sale was executed under a Rule 10b5-1 trading plan, indicating it was a pre-scheduled liquidity move rather than a signal of lack of confidence in the company [7][9] - The shares were sold at a weighted average price of $36.15, closely aligned with the market close price of $36.51 on the same day [7] Product Pipeline and Market Position - Crinetics is advancing a pipeline of novel small-molecule therapeutics, with key clinical-stage candidates including Paltusotine, CRN04777, and CRN04894 [8] - The company is transitioning from development to early commercialization, having generated $7.7 million in revenue for 2025, largely from its lead drug, Palsonify, which earned $5.4 million in its first quarter [10] - Crinetics is expanding its pipeline internationally, recently submitting a marketing application for Palsonify in Brazil, supported by data from 18 clinical trials [11] Financial Position - The company has over $1.4 billion in cash post-offering, positioning it well for future growth despite high annual R&D spending exceeding $330 million [10][11]

Core Viewpoint - Crinetics Pharmaceuticals has submitted a Marketing Authorization Application (MAA) for PALSONIFY™ (paltusotine) to Brazil's National Health Surveillance Agency (ANVISA) for the treatment of acromegaly in adults, marking a significant global milestone for the therapy [1][2]. Group 1: Product Development and Approval - PALSONIFY is the first once-daily, oral, selectively-targeted somatostatin receptor type 2 nonpeptide agonist approved in the US for adults with acromegaly who had an inadequate response to surgery or for whom surgery is not an option [3][6]. - The MAA submission is supported by data from 18 clinical trials, including two Phase 3 trials where all primary and secondary endpoints were met, demonstrating significant biochemical control and symptom management compared to placebo [2][4]. - In Europe, Crinetics has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) regarding the MAA for PALSONIFY for treating acromegaly in adults [3]. Group 2: Clinical Trial Results - In Phase 3 studies, PALSONIFY maintained IGF-1 levels and symptom control in patients switched from monthly injectable medications and rapidly decreased IGF-1 levels in untreated acromegaly patients [4]. - Paltusotine is also in Phase 3 clinical development for carcinoid syndrome associated with neuroendocrine tumors, with Phase 2 study results showing rapid and sustained reductions in flushing episodes and bowel movement frequency [4][6]. Group 3: Company Overview - Crinetics Pharmaceuticals is focused on transforming the treatment of endocrine diseases and related tumors, with expertise in developing novel therapies targeting G-protein coupled receptors (GPCRs) [5]. - The company has a pipeline of over 10 disclosed programs, including late-stage candidates for congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome, as well as other endocrine conditions [6].

Summary of Crinetics Pharmaceuticals FY Conference Call Company Overview - **Company**: Crinetics Pharmaceuticals (NasdaqGS:CRNX) - **Founded**: 2008 with a mission to be the world's leading endocrine company - **First Drug**: Approved for acromegaly, launched in 2025, generating $5.4 million in revenue from over 200 start forms [4][6] - **Pipeline**: Diverse pipeline including drugs for carcinoid syndrome, congenital adrenal hyperplasia (CAH), and Cushing's disease [5][19] Key Points Product Launch and Revenue - **PALSONIFY**: First drug launched, expected to be the standard of care for acromegaly, with strong early demand and over 200 enrollments [6][8] - **Revenue Generation**: $5 million in product revenue in the first quarter, with a pricing of $290,000 for a year of therapy [9][37] - **Reimbursement Process**: Over 50% of patients quickly reimbursed through medical exemption forms; average duration for prior authorizations is about 12 months [9][30] Clinical Trials and Pipeline - **Atumelnant**: An ACTH receptor antagonist in advanced clinical trials for CAH and Cushing's disease, with promising phase 2 data [7][19] - **Paltusotine**: Being studied for carcinoid syndrome, with phase 3 trials initiated; aims to simplify treatment compared to traditional painful injections [20][22] - **CRN09682**: A novel small molecule targeting neuroendocrine tumors, currently in first-in-human phase 1 dose escalation [24][80] Market Potential and Strategy - **Market Size**: Global market for somatostatin receptor ligands (SRLs) is approximately $2.5 billion, with $800 million to $900 million attributed to acromegaly [54] - **Patient Retention**: 80% of patients on SRLs discontinue or switch within five years, indicating a significant opportunity for PALSONIFY to retain patients [64] - **European Approval**: Positive recommendation from CHMP for European approval expected by mid-2026; plans to launch country-by-country [39][40] Future Milestones - **Upcoming Data**: Additional data from ongoing studies expected throughout the year, including updates on atumelnant and CRN09682 [25][81] - **Preclinical Programs**: Progress on TSH receptor antagonist and PTH receptor antagonist, with potential IND filings anticipated next year [84] Additional Insights - **Patient Experience**: Paltusotine offers a once-a-day oral administration, significantly improving patient experience compared to traditional therapies [20][41] - **Regulatory Landscape**: The company is navigating a changing regulatory environment, particularly concerning pricing and reimbursement strategies [39][40] - **Market Execution**: The success of PALSONIFY's launch and the ability to convert patients to paid drug status will be critical for market capture [61][62]

Group 1 - NTT Data plans to increase its workforce in India by 5,000 employees this year, focusing on software programming, consulting, and IT support [1] - The company has seen a doubling of large IT contracts exceeding $100 million in the past year, particularly in manufacturing, logistics, and the public sector [1] - NTT Data is currently constructing four data centers in India as part of a $1.5 billion investment, with a current workforce of 40,000 in the country [2] Group 2 - The Indian data center market is attractive due to the country hosting 20% of the world's data but having less than 6% of global data center capacity [2] - Clients' technology budgets are projected to increase by 7% to 9% this year, up from 6% to 7% last year, driven by investments beyond AI [3]

Core Insights - Crinetics Pharmaceuticals is experiencing early commercial momentum with its product PALSONIFY, which has been adopted by over 125 unique prescribers and has received more than 200 enrollment forms from clinical studies [1][6][2] - The company is transitioning from building a pipeline to establishing a commercial business, with PALSONIFY being its first commercial product launched in the U.S. [2][3] - Crinetics plans to initiate a global phase II/III study for atumelnant in ACTH-dependent Cushing's syndrome, which is characterized as a rare and difficult-to-treat condition [5][12] Commercial Performance - In Q4 2025, Crinetics reported total revenue of $6.2 million, with $5.4 million coming from PALSONIFY [4][16] - The company has seen encouraging formulary momentum, with several top payers adding PALSONIFY to their formularies, often with label-aligned prior authorizations and no step edits [1][6] - Approximately half of the patients are currently reimbursed through commercial or government coverage, while the other half are utilizing the company's Quick Start program [7][6] Financial Overview - Crinetics utilized $326.2 million in cash during 2025, which was favorable compared to the guidance range of $340 million to $370 million [19] - The company ended 2025 with over $1 billion in cash and investments, and after a public offering in January 2026, this amount increased to approximately $1.4 billion [20] - For 2026, the company expects GAAP operating expenses to be between $600 million and $650 million, reflecting increased clinical trials and commercialization activities [21] Pipeline Developments - Atumelnant is the first ACTH receptor antagonist tested in humans and has shown rapid and significant reductions in 24-hour urinary free cortisol in preliminary studies [5][10] - The upcoming EQUILIBRIUM ADCS trial will evaluate safety and efficacy across a range of doses, with a focus on establishing a glucocorticoid replacement strategy [12][13] - Crinetics is also advancing other candidates, including paltusotine for carcinoid syndrome and CRN09682 in oncology, with ongoing clinical trials [14][22] Regulatory Updates - Crinetics received a positive opinion from the CHMP in Europe for PALSONIFY, marking a significant milestone in its global regulatory strategy [22]

分组1 - Crinetics Pharmaceuticals, Inc. reported a quarterly loss of $1.29 per share, which was better than the Zacks Consensus Estimate of a loss of $1.37, representing an earnings surprise of +6.01% [1] - The company posted revenues of $6.16 million for the quarter ended December 2025, exceeding the Zacks Consensus Estimate by 38.05%, compared to zero revenues a year ago [2] - The stock has underperformed, losing about 6.8% since the beginning of the year, while the S&P 500 has gained 1.5% [3] 分组2 - The current consensus EPS estimate for the coming quarter is -$1.25 on revenues of $7.61 million, and for the current fiscal year, it is -$5.05 on revenues of $62.05 million [7] - The Zacks Industry Rank for Medical - Drugs is in the bottom 44% of over 250 Zacks industries, indicating potential challenges for stocks in this sector [8]

Financial Data and Key Metrics Changes - In Q4 2025, the company recognized $6.2 million in total net revenue, comprising $5.4 million from the U.S. launch of PALSONIFY and $0.8 million from a licensing agreement with SKK in Japan [25] - Total revenue for the full year 2025 was $7.7 million, with a cost of product revenue of $1.1 million in Q4 [25][26] - The company ended 2025 with over $1 billion in cash equivalents and investments, excluding $380 million from a public offering in January 2026, bringing total cash to approximately $1.4 billion post-offering [28] Business Line Data and Key Metrics Changes - The launch of PALSONIFY has seen over 200 enrollment forms received in Q4, with more than 125 unique prescribers involved [8][9] - The company is focusing on building a commercial enterprise around PALSONIFY, with a fully integrated team in place to support its launch [10][11] Market Data and Key Metrics Changes - The company is experiencing encouraging formulary momentum with payers, securing wins with top plans in the U.S. for PALSONIFY [9] - Approximately 50% of claims have been pre-reimbursed, with 60% moving into the QuickStart program [63] Company Strategy and Development Direction - Crinetics is transitioning from building a pipeline to establishing a commercial business, aiming to become a leading endocrinology company [7] - The company is focused on launching multiple innovative pharmaceuticals from its pipeline, including paltusotine and atumelnant, while also advancing its nonpeptide drug conjugate program [11][30] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about 2026, highlighting the successful launch of PALSONIFY and ongoing clinical trials for other products [31] - The company is committed to transforming the lives of patients with endocrine diseases and creating long-term sustainable value for stakeholders [31] Other Important Information - The company expects GAAP operating expenses for 2026 to be between $600 million and $650 million, reflecting ongoing investments in clinical trials and commercialization activities [29] - The anticipated increase in operating expenses is due to a full year of commercialization activities supporting PALSONIFY [29] Q&A Session Summary Question: Insights from Phase 2/3 design and previous studies - Management indicated that the structure of the Cushing's disease study is well established, with normalization of urine-free cortisol as a primary endpoint [36][68] Question: Trends in PALSONIFY prescriptions - Management noted positive feedback from prescribers and patients, but refrained from providing specific quantitative trends for the quarter [41][44] Question: Enrollment forms and commercial therapy timeline - Management stated that it is premature to extrapolate the 200 enrollment forms as a consistent run rate, with 50% of patients reimbursed and the other 50% on QuickStart [49][50] Question: Payer dynamics for PALSONIFY - Management reported no significant barriers to treatment access, with most coverage based on labels and a commitment to expedite the QuickStart process [63] Question: ADCS study design and endpoints - Management confirmed that the primary endpoint for the phase 3 study is set by the FDA, focusing on the percentage of patients achieving normal urine-free cortisol [68]

Financial Data and Key Metrics Changes - In Q4 2025, Crinetics Pharmaceuticals recognized $6.2 million in total net revenue, comprising $5.4 million from the U.S. commercial launch of PALSONIFY and $0.8 million from a licensing agreement with SKK in Japan [26] - Total revenue for the full year 2025 was $7.7 million, with a cost of product revenue of $1.1 million in Q4 [26][27] - The company ended 2025 with over $1 billion in cash equivalents and investments, excluding $380 million from a public offering in January 2026, bringing total cash equivalents to approximately $1.4 billion post-offering [29][30] Business Line Data and Key Metrics Changes - The launch of PALSONIFY has seen over 200 enrollment forms received in Q4, with more than 125 unique prescribers involved [8][9] - The company is focusing on building a commercial enterprise around PALSONIFY, with a fully integrated team in place to support its launch [10][11] Market Data and Key Metrics Changes - The company is experiencing encouraging formulary momentum with payers, securing wins with top plans in the U.S. for PALSONIFY [9] - Approximately 50% of claims have been pre-reimbursed, with 60% moving into a Quick Start program [64] Company Strategy and Development Direction - Crinetics is transitioning from building a pipeline to building a business, aiming to establish itself as a leading endocrinology company [7] - The company is focused on launching multiple innovative pharmaceuticals from its pipeline, including paltusotine and Atumelnant, while also advancing its nonpeptide drug conjugate program [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth trajectory for PALSONIFY and the potential for Atumelnant to address significant unmet needs in treating Cushing's disease [11][25] - The company anticipates that existing cash and investments will be sufficient to fund operations into 2030, allowing for continued investment in clinical trials and commercialization activities [30] Other Important Information - The company has received a positive CHMP opinion for PALSONIFY in the treatment of acromegaly, marking a significant milestone for its European regulatory path [32] - The EQUILIBRIUM ADCS study is designed to efficiently assess the safety and efficacy of Atumelnant in treating ACTH-dependent Cushing's syndrome [25] Q&A Session Summary Question: Insights from phase II/III design and previous studies - Management noted that the structure of the Cushing's disease study is well precedented, with normalization of urine-free cortisol as a primary endpoint [34][37] Question: Trends in PALSONIFY prescriptions - Management expressed satisfaction with the launch and noted positive feedback from prescribers and patients, but refrained from providing specific quantitative trends [41][42] Question: Enrollment forms and commercial therapy timeline - Management indicated that it is premature to extrapolate the 200 enrollment forms as a run rate, and about 50% of patients are reimbursed for commercial therapy [49][50] Question: Payer dynamics for PALSONIFY - Management reported positive progress in market access with no significant barriers to treatment, and ongoing engagement with payers [63][64] Question: ADCS study design and endpoints - Management confirmed that the primary endpoint for the phase III study is set by the FDA, focusing on the percentage of patients achieving normal urine-free cortisol [68][69]

Financial Data and Key Metrics Changes - In Q4 2025, the company recognized $6.2 million in total net revenue, with $5.4 million from the U.S. commercial launch of PALSONIFY and $0.8 million from a licensing agreement with SKK [24] - Total revenue for the full year 2025 was $7.7 million, with a cost of product revenue of $1.1 million in Q4 [24][25] - Research and development expenses for Q4 were $85.1 million, down from $90.5 million in Q3, while selling, general, and administrative expenses were $53.7 million, relatively stable compared to $52.3 million in Q3 [25] - The company ended 2025 with over $1 billion in cash equivalents and investments, which does not include $380 million from a public offering in January 2026 [26] Business Line Data and Key Metrics Changes - The launch of PALSONIFY has seen over 200 enrollment forms in Q4, with more than 125 unique prescribers involved [6][7] - The company is focusing on building a fully integrated commercial enterprise to support PALSONIFY, including sales professionals and patient support services [8][9] Market Data and Key Metrics Changes - The company is experiencing encouraging formulary momentum with payers, securing wins with top plans in the U.S. for PALSONIFY [7] - Approximately 50% of patients are reimbursed for commercial or government payers, while the other 50% are utilizing the QuickStart program [48][62] Company Strategy and Development Direction - The company is transitioning from building a pipeline to building a business, aiming to establish PALSONIFY as the new standard of care for acromegaly [5][10] - The focus is on expanding the commercial business and advancing clinical trials for other pipeline candidates, including atumelnant for CAH and Cushing's disease [10][30] - The company received a positive CHMP opinion for PALSONIFY in the EU, reflecting the strength of their data [30] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about 2026, highlighting simultaneous execution across the portfolio and ongoing advancements in clinical trials [30] - The company believes existing cash and investments will be sufficient to fund operations into 2030, providing a significant runway for commercialization and clinical development [27] Other Important Information - The company is committed to transforming the lives of people with endocrine diseases and creating long-term sustainable value for stakeholders [30] - The EQUILIBRIUM ADCS study is designed to assess the safety and efficacy of atumelnant in treating ADCS, with a seamless transition from phase 2 to phase 3 [20][23] Q&A Session Summary Question: Insights from Phase 2/3 design and learnings from other studies - Management noted that the structure of the Cushing's disease study is well precedented, with normalization of urine-free cortisol as a primary endpoint [34][66] Question: Trends in PALSONIFY prescriptions - Management is pleased with the launch and early positive experiences from prescribers and patients, but refrained from providing quantitative comments on trends [40][43] Question: Enrollment forms and commercial therapy timeline - Management indicated that it is premature to extrapolate the 200 enrollment forms but expressed satisfaction with the number [47] Question: Payer dynamics for PALSONIFY - Management reported positive progress in market access with no significant barriers to treatment, and most coverage is based on the product's label [62] Question: Phase 3 endpoints for ADCS study - The primary endpoint for phase 3 is set by the FDA, focusing on the percentage of patients achieving normal urine-free cortisol [66]

February 26, 2026 Fourth Quarter and Full Year 2025 Financial Results and Business Update Forward Looking Statements This presentation contains forward-looking statements. Crinetics Pharmaceuticals, Inc. ("Crinetics," the "company," "we," "us," or "our") cautions you that all statements other than statements of historical facts contained in this presentation are forward-looking statements. Such forward-looking statements include, but are not limited to, statements regarding: our ability to effectively comme ...