09-05-2025
Crinetics Pharmaceuticals Inc (CRNX) Q1 2025 Earnings Call Highlights: Strategic Growth and ...
Release Date: May 08, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Crinetics Pharmaceuticals Inc (NASDAQ:CRNX) is strategically positioned for long-term sustainable growth with a focus on the anticipated commercial launch of their first products this year.
The company has a robust pipeline, including two late-stage candidates and three additional candidates in pre-clinical studies.
Crinetics Pharmaceuticals Inc (NASDAQ:CRNX) has a strong financial position with $1.3 billion on the balance sheet, allowing continued investment in their pipeline and support for prospective launches.
The anticipated launch of Paltustine for acromegaly is a pivotal milestone, with positive feedback from healthcare professionals and strong patient advocacy partnerships.
Regulatory engagement with the FDA and European Medicines Agency is proceeding on track, with no disruptions anticipated for the Paltustine NDA review.
Research and development expenses increased by 43% compared to the same period in 2024, primarily due to additional personnel and increased manufacturing costs.
Selling, general, and administrative expenses rose by 71% compared to the same period in 2024, driven by growth to support ongoing programs and the planned commercial launch.
Cash used in operations increased significantly, with expectations for cash use in operations to be between $340 and $380 million for 2025.
The company anticipates a measured uptake of Paltustine during early launch, with coverage expected to build progressively over the first 6 to 9 months.
There is a significant unmet need for safe, highly efficacious, easy-to-administer treatments, indicating challenges in meeting current market demands.
Warning! GuruFocus has detected 3 Warning Signs with CRNX.
Q: Could you talk about the power of your innovative primary endpoint, which is a co-primary, and have you been able to collect any data from cohort 4 yet? A: The study is highly powered to detect statistically significant differences between the treatment and placebo arms. Cohort 4 is enrolling, but we can't comment on the timing of data yet. The primary endpoint is better described as a composite endpoint rather than a co-primary endpoint. It involves a responder analysis where a responder is defined as having both normal glucocorticoid doses and normal A4 levels. - Dr. Alan Krasner, Chief Endocrinologist
Q: Is the CAH study design fully signed off on by the FDA as a trial that could support registration, and what indication statement would you hope to secure assuming the trial is successful? A: The protocol was developed with input from the FDA and other health authorities, and they are aware of the final study design. We aim to develop a drug that treats CAH, requiring glucocorticoids only for adrenal insufficiency prevention. The indication might differ slightly from existing ones, as our drug aims to drive androgen reduction without needing glucocorticoids for that purpose. - Dr. Dana Pezzutti, Chief Medical and Development Officer
Q: What's the rationale for testing the primary endpoint at a single point in time at 32 weeks instead of averaging across multiple time points? A: Responder analyses are typically conducted at single points in time. While there's always variability with biochemical markers, A4 is one of the least variable in this disease state. The compound is expected to achieve both components of the composite primary endpoint, minimizing the risk of variability affecting results. - Dr. Alan Krasner, Chief Endocrinologist
Q: What is the rationale for looking at morning dosing versus evening dosing in the fourth cohort? A: Morning dosing might be more convenient for patients, and we want to explore this option to provide future flexibility. The timing of the drug in relation to the diurnal rhythm of the axis, including in CAH patients, is important to ensure it doesn't have a significant effect. - Dr. Scott Struthers, CEO
Q: How are you thinking about launch strategy in different geographies, especially in Europe and Latin America? A: In Europe, patient concentration is even more at centers of excellence compared to the US. We are preparing for a launch in Germany and have a small team in place. In Latin America, Brazil is a key market due to its high unmet need and concentrated patient population. We plan to expand gradually and thoughtfully. - Isabel Califanos, Chief Commercial Officer
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
This article first appeared on GuruFocus.
