Crinetics' Q3 2025: Contradictions Emerge on Patient Enrollment, Launch Strategy, Reimbursement, and Prescriber Engagement

Date of Call: November 06, 2025

Financials Results

• Revenue: $0.1M licensing revenue (no PALSONIFY launch revenue recognized in Q3; product shipments occurred in early Q4)

Guidance:

• Net cash used in operations for 2025 expected to be $340 million to $370 million.
• Existing cash and investments expected to fund operations into 2029 (no change to runway guidance).

Business Commentary:

* PALSONIFY Launch Success: - Crinetics Pharmaceuticals reported that the launch of PALSONIFY has been going ``very well'' with significant progress in the initial 31 days since FDA approval. - The company indicated that all U.S. patients in their open-label extension studies are transitioning to commercial supplies, and the team is executing seamlessly.

• Clinical Pipeline Advancement:
• Crinetics Pharmaceuticals has multiple late-stage programs advancing, including trials for carcinoid syndrome and CAH, with initial data expected from the T2CANS study in early 2026.

• The company is committed to advancing its pipeline and expects a robust set of data readouts, including from its CALM-CAH adult Phase 3 trial and BALANCE-CAH Phase 2 pediatric study.

• Commercialization Strategy:

• PALSONIFY is initially targeting patients who have switched from other therapies, with 95% of filled prescriptions coming from this demographic.

• The launch strategy involves a three-phase approach to expand the acromegaly market by returning diagnosed but discontinued patients to care and improving awareness to diagnose undetected cases.

• Financial Performance:

• Crinetics reported $0.1 million in revenue from its licensing agreement with SKK in Q3, and expects to recognize revenue from PALSONIFY in Q4.
• Research and development expenses were $90.5 million for Q3, reflecting investments in clinical programs and the advancement of its non-peptide drug conjugate platform.

Sentiment Analysis:

Overall Tone: Positive

• Management repeatedly stated the PALSONIFY launch is "going very well" and "off to a very good start," highlighted favorable payer feedback and early reimbursements, and emphasized a "deep pipeline, a strong balance sheet and a clear path to continued value creation."

Q&A:

• Question from Catherine Novack (JonesTrading Institutional Services, LLC, Research Division): Can you tell us what the evidence is for somatostatin receptor ligands in NETs and will you ever want to conduct survival studies with paltusotine alone?
  Response: SRLs are cytostatic; paltusotine is expected to show similar PFS effects — PFS is an appropriate surrogate for NETs and long survival trials would be impractical; monitoring will continue in OLE and Phase 3.

• Question from Catherine Novack (JonesTrading Institutional Services, LLC, Research Division): Any clarity on what model you saw the tox signals for the Graves' disease candidate — on-target or unexpected receptor activity?
  Response: Toxicity was an idiosyncratic finding in IND-enabling tox studies, not on-target; program timelines delayed while prioritizing backup molecules.

• Question from Cory Jubinville (LifeSci Capital, LLC, Research Division): You mentioned the sales force has called on >95% of top priority prescribers — how many prescribers is that specifically and what's the initial perception/conversion?
  Response: About ~110 total prescribers on the list; field contacted >95% of top priority targets and reception has been favorable with initial prescriptions originating from that prescriber list.

• Question from Cory Jubinville (LifeSci Capital, LLC, Research Division): Why are 70% of scripts coming from community vs PTCs — are centers lagging or is this early-sample noise?
  Response: Community physicians are more nimble and proactive (calling patients), while PTCs require normal administrative setup (EMR prescribing workflows, pharmacy activation); not resistance, just logistical lag.

• Question from Yasmeen Rahimi (Piper Sandler & Co., Research Division): How do you decide to provide free drug while securing reimbursement (Quick Start), and will early 2026 CAH data include all 10 patients and what will it show?
  Response: Specialty pharmacies file PAs first; Quick Start supplies interim drug when PAs are challenged — ~50% of early claims reimbursed and goal is Quick Start turnaround below ~57 days; Cohort 4 plus early OLE will give directional evidence of adrenal androgen suppression and possible steroid reductions but sample is small.

• Question from Douglas Tsao (H.C. Wainwright & Co, LLC, Research Division): Are you seeing awareness-driven (ground-up) demand versus clinician-initiated prescribing for PALSONIFY?
  Response: Both patient-driven requests and physician-initiated switches are observed; it's early and too small to quantify proportions.

• Question from Selena Zhang (on behalf of Maxwell Skor) (Morgan Stanley): Has the timing of benefit verification for the Quick Start program met expectations and when will you have visibility into prescribing trends?
  Response: Benefit verification occurs during Quick Start; target is to be faster than the rare-disease average (~57 days); clearer prescribing trend visibility will come after a full quarter of launch data.

• Question from Jin Law (Goldman Sachs Group, Inc., Research Division): Based on launch experience what has been going well and where can you improve across commercial, Medicare and Medicaid?
  Response: Execution (sales, marketing, market access, CRM/omnichannel) is strong; payer feedback favorable and coverage approvals occurring across commercial, Medicare and Medicaid; improvements are incremental administrative optimizations.

• Question from Jin Law (Goldman Sachs Group, Inc., Research Division): Are the early prescriptions mostly commercial, and what's the breakdown for Medicare/Medicaid?
  Response: There is a mix across commercial, Medicare and Medicaid; majority are commercial consistent with expected payer mix, and approvals have been obtained in all three segments.

• Question from Jin Law (Goldman Sachs Group, Inc., Research Division): What is the turnaround time for payers to approve PALSONIFY once prior authorization requirements are met?
  Response: Too early to calculate meaningful payer turnaround times given small sample size in the initial launch.

• Question from Jin Law (Goldman Sachs Group, Inc., Research Division): Are you offering payer rebates for commercial plans?
  Response: No — commercial payer rebates are not being offered.

• Question from Nick Lorusso (on behalf of Tyler Van Buren) (TD Cowen): With 95% of filled prescriptions from switch patients, what's the plan to reach additional treatment‑naive patients and which will drive long-term growth?
  Response: Three-phase strategy: focus initially on switches and naive patients, then re-engage patients off therapy, and finally improve diagnosis — long-term growth driven by re-engaging lost-to-follow-up patients and finding undiagnosed patients.

• Question from Brandon Frith (Wolfe Research): How will you position PALSONIFY as first-line given generics on the market?
  Response: PALSONIFY's rapid onset, reliable disease and symptom control, and comprehensive support services differentiate it from injectables/generics; payers see the value proposition.

• Question from Jonathan Wolleben (Citizens JMP Securities, LLC, Research Division): How should we think about timing/sequence of the three launch phases and are there benchmarks to move between them?
  Response: Phases are layered rather than strictly sequential — continue Phase 1 focus while progressively increasing efforts to re-engage patients and improve diagnosis.

• Question from Jonathan Wolleben (Citizens JMP Securities, LLC, Research Division): Is the current sales force right-sized to handle expansion over time?
  Response: Yes — coverage is appropriate for a concentrated prescriber base and was designed to address both community and PTC needs.

• Question from Jessica Fye (JPMorgan Chase & Co, Research Division): What should we focus on in Cohort 4 Atumelnant data and how much will it read into potential steroid reductions in Phase 3?
  Response: Cohort 4 and early OLE will give directional insight on steroid reductions and adrenal androgen suppression but numbers are small and not definitive for powering Phase 3 expectations.

• Question from Jessica Fye (JPMorgan Chase & Co, Research Division): When should we expect preliminary Phase 2 pediatric Atumelnant data?
  Response: No exact timing provided; pediatric enrollment is staged by age with dose validation before expansion into younger cohorts.

• Question from Patrick Ho (Stifel): Are payer dynamics for naive patients different from switch patients?
  Response: Dynamics are similar — some claims reimbursed directly and others processed via the Quick Start program.

• Question from Joseph Schwartz (Leerink Partners LLC, Research Division): How does early traction compare to market research in willingness to prescribe?
  Response: Traction aligns with expectations — prescribers show no meaningful pushback and momentum is building as patients start therapy.

• Question from Joseph Schwartz (Leerink Partners LLC, Research Division): How fast will inertia shift to excitement given clinicians' familiarity with legacy treatments?
  Response: There is substantial prescriber excitement; remaining inertia reflects appointment cadence (6–12 months); urgency and early positive experiences will accelerate uptake.

• Question from Anthea Li (on behalf of Dennis Ding) (Jefferies LLC, Research Division): How many OLE patients are transitioning to commercial supply and will that contribution be in Q4 or later; any update on GLP programs/candidate selection?
  Response: All 22 OLE U.S. patients are enrolling to transition to commercial supply at various stages and most should complete enrollment by year-end (no exact counts); early-stage GLP programs are under evaluation but no new clinical timelines or specifics provided.

Contradiction Point 1

Patient Enrollment Dynamics

It involves the impact of new drug launches on patient enrollment in clinical trials, which affects the timeline and resources for clinical development.

How many top priority prescribers were included? What is the concentration of acromegaly patients in these centers? How many have converted to prescribers or are adopting PALSONIFY into their practice? - Cory Jubinville (LifeSci Capital, LLC)

2025Q3: The team has reached more than 95% of the highest priority prescribers. The response from the community has been favorable, with many prescriptions coming from community-based practitioners. - Ralph Struthers(CEO)

How does the CRENESSITY launch affect Phase III CAH study enrollment, and which patient types are more likely to switch to CRENESSITY than enroll in the study? - Joseph Schwartz (Leerink Partners)

2025Q2: The CRENESSITY launch positively impacts enrollment in Phase III CAH studies. - Ralph Struthers(CEO)

Contradiction Point 2

Launch Strategy and Commercial Execution

It involves differing perspectives on the launch strategy and commercial execution, which are critical for market penetration and revenue generation.

Can you outline the timeline and sequence for the PALSONIFY launch phases? How is the sales team being right-sized to support expansion? - Jonathan Wolleben(Citizens)

2025Q3: The focus is on phased efforts rather than strict sequences. Efforts will layer on to expand beyond initial patients. The sales force is well-positioned, with concentrated prescriber coverage and a focus on community involvement. - Ralph Struthers(CEO)

Can you clarify the conservative launch expectations for paltusotine and outline its global strategy? - Tyler Van Buren(TD Cowen)

2024Q4: Our approach to the market is to leverage Crinetics' data, insights, and capabilities and then use that to support payers to facilitate access, commercial operations to support a smooth product launch, and 1.1Health to increase patient awareness through our consumer marketing efforts. - Isabel Kalofonos(CMO)

Contradiction Point 3

PALSONIFY Patient Reimbursement and Market Access Strategy

It highlights differing statements about the nature and timeline of reimbursement issues faced by patients and the strategy to address these challenges, which could impact adoption, revenue, and patient experience.

How are you balancing free drug provision with reimbursement? How many patients in Cohort 4 will have data by early 2026, and what are the key takeaways? - Yasmeen Rahimi (Piper Sandler & Co., Research Division)

2025Q3: The market access team is executing well, with 50% of claims reimbursed. The Quick Start program is offered if prior authorization is challenged, with a target to resolve issues within 57 days. - Isabel Kalofonos(CMO)

What is the reimbursement rate and processing time for in-network patient reimbursements? - Vishnu Lekh (Mizuho Securities USA)

2024Q3: In Q4, we believe that we'll have about 60% of our patients or more being reimbursed at the time we prescribe their drug. - Isabel Kalofonos(CMO)

Contradiction Point 4

PALSONIFY Launch and Prescriber Engagement Strategy

It involves differences in the description of the launch strategy and the level of engagement with prescribers, which could impact the success and timeline of the PALSONIFY launch.

How many prescribers are prioritized? What is the acromegaly patient concentration in these centers? How many prescribers have adopted or are adopting PALSONIFY? - Cory Jubinville (LifeSci Capital, LLC)

2025Q3: We've reached more than 95% of the highest priority prescribers. The response from the community has been favorable, with many prescriptions coming from community-based practitioners. - Ralph Struthers(CEO)

How is the overall launch progressing? Is there strong prescriber demand for PALSONIFY? - Sweta Iyer (RBC Capital Markets, LLC)

2024Q3: We have engaged the highest priority prescribers to ensure PALSONIFY is among the first-line treatment options in these high-volume centers. - Ralph Struthers(CEO)