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]

Crinetics Pharmaceuticals FY Conference Summary Company Overview - **Company**: Crinetics Pharmaceuticals (NasdaqGS:CRNX) - **Date of Conference**: January 13, 2026 - **Key Speaker**: Scott Struthers, CEO Core Industry and Company Insights Achievements and Developments - **Palsinify Approval**: Received broad label approval for Palsinify for the treatment of acromegaly on its PDUFA date, marking a significant milestone for the company [3][7] - **Successful Launch**: The launch of Palsinify has been successful, with over 200 patients enrolled in the last quarter and more than 125 unique prescribers involved [8][9] - **Pipeline Expansion**: Positive phase two data reported for atumelnant, with ongoing phase three studies for carcinoid syndrome and new compound 9682 in phase one/two studies for neuroendocrine tumors (NETs) [3][4] Financial Position - **Funding**: The company has approximately $1.4 billion in the bank, providing a solid foundation for operations through 2030 [4] - **Revenue Generation**: Achieved over $5 million in revenue last year, with expectations for growth as Palsinify gains market acceptance [11] Patient Engagement and Market Strategy - **Patient Services**: Implemented a comprehensive patient services program, including a Quick Start program to facilitate access to Palsinify [10][13] - **Market Access**: Focus on expanding prescriber base and activating patients who have previously settled with their conditions [34][35] - **Payer Engagement**: Strong efforts to communicate the value of Palsinify to payers, with CVS Caremark covering over 27 million lives [36][38] Pipeline and Future Prospects Palsinify and Acromegaly - **Market Potential**: There are approximately 36,000 patients with acromegaly in the U.S., with only 3,000 currently on standard care, indicating significant room for growth [14][15] - **Blockbuster Potential**: The CEO expressed confidence that Palsinify could become a blockbuster drug, aiming to help more than 5,000 patients per $1 billion in revenue [15] Atumelnant and CAH - **Clinical Development**: Atumelnant is positioned as a treatment for congenital adrenal hyperplasia (CAH), with promising phase two data showing significant reductions in adrenal androgens [20][25] - **Patient Population**: Approximately 12,000 patients in the U.S. are affected by CAH, with a focus on achieving normal hormone levels through treatment [25] 9682 and Neuroendocrine Tumors - **New Platform**: 9682 is being developed as a drug targeting agent for SST2-positive expressing solid tumors, with a phase 1/2 trial currently underway [27][28] - **Market Opportunity**: There are 11,000-21,000 patients currently treated for neuroendocrine tumors, with many more not receiving treatment [28] Key Milestones and Future Outlook - **2030 Vision**: The company aims to emerge as a premier endocrinology business with two marketed products and four approved indications by 2030 [30] - **Clinical Pipeline**: Anticipates having seven clinical pipeline candidates in development, with ongoing investments in discovery labs [30] Additional Insights - **Patient-Centric Approach**: Emphasis on patient stories and experiences to enhance engagement and support for Palsinify [12][13] - **Regulatory Strategy**: The company is actively monitoring and managing clinical trials to ensure high-quality data and compliance [45][46] This summary encapsulates the key points from the Crinetics Pharmaceuticals FY Conference, highlighting the company's achievements, pipeline developments, financial position, and strategic outlook for the future.

JANUARY 2026 Beyond Innovation to Impact: Building the Premier Endocrinology Business J.P. Morgan Healthcare Conference Angela Living with Acromegaly Forward Looking Statements and Legal Disclaimers 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 forw ...

Summary of Crinetics Pharmaceuticals (CRNX) Conference Call Company Overview - **Company**: Crinetics Pharmaceuticals (CRNX) - **Event**: Jefferies Healthcare Conference, June 5, 2025 - **Key Speaker**: CEO Scott Struthers Core Points and Arguments Product Pipeline and Milestones - Crinetics is preparing for a PDUFA date on September 25 for its first molecule, paltusotine, aimed at treating acromegaly [2][3] - The company has a robust pipeline, including a second drug, Atumelnat, targeting congenital adrenal hyperplasia and Cushing's disease [3][4] - Crinetics has developed all its drugs in-house, with the exception of licensing paltusotine rights in Japan and a technology platform to Radionetics [4][6] Financial Position - The company is in a strong financial position with $1 billion in the bank, sufficient to last until 2029 without partnerships [6] Market Dynamics for Acromegaly - The acromegaly market has approximately 11,000 addressable patients, with segments for new therapies, switching from existing treatments, and re-engaging lost patients [13][15] - There is a significant unmet need, with 20% of patients requiring more frequent injections than the standard regimen [14] - Approximately 80% of patients discontinue treatment within three years, indicating a potential market for re-engagement [15][16] Sales and Marketing Strategy - The company is onboarding its sales team and engaging with key opinion leaders (KOLs) to improve patient care and drug delivery [9][10][18] - Crinetics aims to educate physicians on treatment guidelines and the importance of managing acromegaly effectively [25][26] Payer Engagement and Pricing Strategy - Crinetics has been actively engaging with payers, receiving positive feedback regarding the drug's efficacy and the cost savings associated with reducing wastage from current injectable therapies [32][33] - The company is still evaluating its pricing strategy based on value and market research [38] Future Outlook - The company anticipates a lag in revenue realization post-launch due to formulary updates and patient visits [40] - Crinetics is preparing for Phase III trials for Atumelnat, with a focus on rethinking treatment paradigms for congenital adrenal hyperplasia [42][44] Additional Important Content - The company emphasizes the importance of improving healthcare delivery for acromegaly patients, not just providing a new drug [10][12] - There is a focus on patient education and support services to enhance treatment adherence and outcomes [21][22] - The company has a diverse pipeline with multiple ongoing programs, indicating a long-term growth strategy [54]

Financial Data and Key Metrics Changes - The company recognized $400,000 in revenue for Q1 2025, down from $600,000 in Q1 2024, with revenue being non-cash based on amortization of licensing payments [39] - Research and development (R&D) expenses increased by 43% to $76.2 million in Q1 2025 compared to the same period in 2024 [39] - Selling, general and administrative (SG&A) expenses rose by 71% to $35.5 million in Q1 2025 compared to Q1 2024 [40] - Cash used in operations was $88.5 million for Q1 2025, compared to $52.9 million in Q1 2024, with an anticipated cash usage of $340 million to $380 million for the full year [41][42] Business Line Data and Key Metrics Changes - The company is focused on the anticipated commercial launch of paltusotine, which is expected to significantly improve treatment for acromegaly [7][10] - The company is advancing a robust pipeline, including two late-stage candidates and three additional candidates in preclinical studies [7][8] Market Data and Key Metrics Changes - The company is preparing for the U.S. launch of paltusotine in September, with significant engagement with healthcare professionals and payers [12][19] - The company anticipates major uptake during the early launch phase as it educates healthcare providers and patient communities about paltusotine [23] Company Strategy and Development Direction - The company aims to become a fully integrated global commercial organization, with a strong focus on patient-centric therapies [6][10] - The company is actively engaging with regulatory authorities and preparing for the launch of paltusotine, which is seen as a defining milestone [10][24] - The company is also pursuing a Phase III trial for adomelna in congenital adrenal hyperplasia (CAH), aiming to redefine treatment standards [11][29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory engagement with the FDA and the progress of clinical development activities [10][24] - The company remains optimistic about the potential of paltusotine to become the new standard of care in acromegaly, addressing significant unmet needs [23][24] Other Important Information - The company ended Q1 2025 with approximately $1.3 billion in cash, which is expected to fund operations into 2029 [42] - The company has received orphan drug designation for paltusotine in the EU, highlighting the unmet need in acromegaly [25] Q&A Session Summary Question: Could you talk about the powering of your very innovative primary endpoint? - The study is highly powered to detect statistically significant differences between treatment and placebo arms, and the endpoint is better described as a composite rather than a co-primary endpoint [47][49] Question: Is the CALM CAH study design fully signed off on by FDA? - The protocol was developed based on input from the FDA and other health authorities, and they are aware of the final study design [53][54] Question: What is the rationale for looking at morning dosing versus evening dosing in the fourth cohort? - Morning dosing may be more convenient for patients, and the study aims to explore this option [60][61] Question: How are you thinking about launch strategy in different geographies? - The company is preparing for the launch in Germany, where there is a significant unmet need, and is also considering expansion into Brazil [68][69] Question: Can you give an update on enrollment and follow-up for the long-term extension study? - Enrollment is proceeding, and updates will be provided once a critical mass is reached [87] Question: Is there a risk that A4 variability may lead to some non-responders? - Responder analyses are generally conducted at single points in time, and there is confidence that the compound can achieve both components of the composite primary endpoint [57][58]