Crinetics' Q3 2025: Contradictions Emerge on PALSONIFY Launch, Prescription Trends, and Payer Value Proposition

Date of Call: October 28, 2025

Financials Results

• Revenue: $0.1M recognized in Q3 2025 from Japanese licensing (SKK); no Palsanafy revenue recognized in Q3 due to approval timing; product shipped in early Q4 and revenue recognized in Q4.

Guidance:

• Maintaining 2025 net cash used in operations guidance of $340M–$370M.
• Existing cash and investments expected to fund operations into 2029.
• Will provide full Q4 launch metrics in January (revenue, new patient starts, unique prescribers, payer progress).

Business Commentary:

• Palsanafy Launch Success:
• In the first 31 days since approval, Crinetics Pharmaceuticals reported significant progress in the launch of Palsanafy with the first patients receiving their bottles within 11 days after the PDUFA date.
• The initial patients are those switching to Palsanafy from other therapies, but there are also newly diagnosed patients starting on Palsanafy as their first medical therapy.

• The success is attributed to the strong label, comprehensive field team efforts, and positive feedback from patients, physicians, and payers.

• Clinical Program Momentum:

• Crinetics Pharmaceuticals is advancing multiple late-stage programs, including carcinoid syndrome, CAH adult phase three trial, balanced CAH phase two pediatric study, and Bravus 2 study for CRN-9682.
• The company anticipates key data readouts from these programs throughout the next 18 to 24 months.

• This momentum is driven by the strength of the discovery and development efforts and clinical pipeline expansion.

• Financial Performance:

• The company recognized $0.1 million in revenue from licensing in Q3, and revenue related to Palsanafy is expected in Q4.
• Research and development expenses were $90.5 million in Q3, reflecting continued investments in clinical programs and advancements in the NDC platform.

• The financial performance is supported by disciplined execution and strategic investments in advancing the pipeline and commercialization efforts.

• Payer Reimbursement and Access:

• Prior authorizations for Palsanafy have been mostly straightforward, with some approved for up to 12-month supplies before formulary coverage.
• Approximately 50% of claims have been reimbursed, with a mix of commercial, Medicare, and Medicaid patients.
• The positive payer response is attributed to the comprehensive pre-launch engagement and the high efficacy and ease of administration demonstrated by Palsanafy.
  

  Sentiment Analysis:

  Overall Tone: Positive

  • Management repeatedly described the launch as 'going very well' with 'encouraging' payer, physician and patient feedback; reported $1.1B cash balance and maintained 2025 net cash-use guidance of $340–$370M with runway into 2029; multiple programs advancing with upcoming data readouts.

Q&A:

• Question from Kathryn Novak (Jones Trading): I’m interested in the PFS data for palbtucetine presented at NANETS — what is the evidence for SRLs in this setting and would you ever conduct survival studies? Also, any clarity on the tox signal that delayed the Graves’ disease candidate — model and on/off-target?
  Response: Early exploratory OLE PFS data for palbtucetine are comparable to expected SRL cytostatic effects (PFS used as surrogate; survival trials impractical due to slow tumor growth); the Graves’ TSH candidate showed an idiosyncratic, non–on-target toxicity prompting IND delays and prioritization of backup molecules.

• Question from Corey Trubenville (LifeSci Capital): You mentioned the sales force has called on >95% of top priority prescribers — how many prescribers is that, what portion of addressable patients are at those centers, and what was initial physician reception and conversion to prescribers?
  Response: Approximately 110 top prescribers (~95% contacted); initial reception has been favorable with early prescriptions largely from switch patients; 70% of current prescribers are community-based and uptake is encouraging.

• Question from Yasmeen Rahimi (Purpose Sandler): How do you decide to provide free drug while obtaining reimbursement (Quick Start), and for Etumelna cohort 4 will you have all 10 patients early 2026 and what will that data show?
  Response: Specialty pharmacies file prior authorizations first; Quick Start bridges patients when PA issues arise (aim to minimize time on bridge), ~50% of claims already reimbursed; cohort 4 plus initial OLE Etumelna data due in January will be small but should provide directional evidence on steroid reductions and benefit–risk.

• Question from Douglas Sowell (HC Wainwright): Is the early demand coming from grassroots patient awareness or clinician outreach in the acromegaly community?
  Response: Uptake is a mix of physician-initiated switches and patient-driven requests; community practices have been especially nimble and are driving substantial early prescriptions.

• Question from Maxwell Score (Morgan Stanley): Has Quick Start benefit verification timing met expectations and when will you have clearer visibility into prescribing trends?
  Response: Quick Start in rare disease averages ~57 days and the company aims to be faster; clearer prescribing trends and detailed launch metrics will be available after a full Q4 (to be reported in January).

• Question from Richard Law (Goldman Sachs): What’s going well and where can you improve in the launch across commercial, Medicare and Medicaid; payer turnaround and rebate strategy?
  Response: Execution across sales, marketing, market access and omnichannel is working well; approvals/claims have occurred across commercial, Medicare and Medicaid with majority commercial claims; sample size too small for robust payer turnaround metrics yet; no commercial rebate contracts planned.

• Question from Tyler Van Buren (TD Cowen): With 95% of filled scripts from switch patients, what’s the plan to reach more treatment‑naïve patients and what will drive long‑term growth?
  Response: Immediate growth from switches plus modest new diagnoses (~500 patients/year); long‑term expansion driven by re‑engaging patients lost to follow‑up (~4,500) and improving diagnosis of undiagnosed patients (~17,000).

• Question from Andy Chen (Wolf Research): How will you position Palsanafy as first‑line vs generics on the market?
  Response: Palsanafy’s faster and more reliable control (weeks vs months for depots), label and supportive services differentiate it from generics; payers recognize the value and uptake is not being hindered by generics.

• Question from John Wallaben (Citizens): How do you sequence/phases of the launch and is the current sales force sized to handle expansion?
  Response: Phases are layered (focus on switches/naive first, then re‑engage lost patients, then awareness/diagnosis); current sales force was sized for community and centers and is appropriate for planned expansion.

• Question from Jessica Fine (JP Morgan): What should we focus on in Etumelna cohort 4 and the Phase 2 OLE regarding steroid reductions and how informative will these data be for Phase 3?
  Response: Cohort 4 (12 weeks) plus early OLE (longer follow‑up) will provide directional evidence that Etumelna enables steroid reductions and favorable benefit–risk, but sample sizes are small and not powered for definitive efficacy estimates.

• Question from Alex Thompson (Stiefel): For NIH (treatment‑naïve) patients, are payer dynamics different than for switch patients?
  Response: Payer dynamics are similar for NIH and switch patients — a mix of reimbursed claims and Quick Start bridging; still early in launch.

• Question from Joe Schwartz (Lerank Partners): How does early traction compare to your market research on willingness to prescribe?
  Response: Traction aligns with expectations: prescribers are enthusiastic with no material pushback; any inertia reflects normal appointment cadences rather than reluctance to prescribe.

• Question from Dennis Ding (Jefferies): How many OLE patients are transitioning to commercial supply and when will we see the contribution; any update on GLP‑1/GLIP program candidate selection?
  Response: All 22 U.S. OLE patients are transitioning to commercial supply in various stages with most monitoring completed by year‑end (exact timing not specified); early-stage GLP‑1/GLIP work is ongoing internally with no new public timing disclosed.

Contradiction Point 1

PALSONIFY Launch and Prescription Trends

It involves differing expectations and experiences regarding the launch of PALSONIFY, particularly concerning the number of prescriptions and the timing of benefit verification, which are critical for understanding the product's market penetration and reimbursement status.

Has the Quick Start program's benefit verification timing met expectations? When will prescribing trend visibility improve? - Maxwell Score (Morgan Stanley)

2025Q3: We have seen over 50% of claims reimbursed without it. We expect more visibility into prescribing trends as the quarter progresses. - Isabel Kalofonos(CMO)

What is the long-term revenue potential for Crinecersa in the US and ex-US markets? - Andy Hinkly (William Blair)

2024Q3: We have seen very good patient reimbursement as we go through the program. And what we're seeing today is probably over 50% reimbursement today. - Derek Chalmers(CEO)

Contradiction Point 2

Patient Awareness and Doctor Recommendations

It involves differing perspectives on how patient awareness and doctor recommendations are contributing to prescriptions, which are crucial factors in understanding market adoption and product acceptance.

Are you seeing increased demand from community or centers of excellence? How is patient awareness affecting prescription trends? - Douglas Sowell (HC Wainwright)

2025Q3: We're seeing a mix of both, with prescriptions coming from customers who heard about Palsanafy and from doctors who recommend it. Patient awareness and doctor recommendation are both contributing to prescriptions. - Dr. Scott Struthers(CEO)

What's the latest update on the CRAVITY study and expected top-line results? - Sapna Srivastava (Mizuho Securities)

2024Q3: What we have learned over the past 6 months is because of the efforts of the team here and because the doctor's education and the patient's education are so sophisticated, is that the impact of the awareness activities has been very effective. - Derek Chalmers(CEO)

Contradiction Point 3

Commercialization and Drug Access

It involves differing perspectives on the approach to commercialization and ensuring drug access for PALSONIFY, which are critical for market adoption and patient care.

How are you managing free drug provisions during reimbursement, and what are your expectations for the TUCAN study data in 2026? - Yasmeen Rahimi (Purpose Sandler)

2025Q3: We partner with specialty pharmacies for benefit verification. We have seen 50% of claims reimbursed, with Quick Start programs for challenging cases. - Isabel Kalofonos(CMO)

What is the distribution of PALSONIFY, and will it be captured in data services like IQVIA? - Charles Moore (Baird)

2025Q2: We are utilizing specialty pharmacies not only for distribution but also for benefit verification before we deliver the drug. As you know, there are typically out-of-pocket costs for patients. - Isabel Kalofonos(CMO)

Contradiction Point 4

Launch Strategy and Focus

It involves differing perspectives on the approach to launching PALSONIFY and the focus areas for driving growth, which are critical for strategic planning and investor expectations.

Are you seeing increased demand from community or centers of excellence? Is patient awareness driving prescription trends? - Douglas Sowell (HC Wainwright)

2025Q3: We're seeing a mix of both, with prescriptions coming from customers who heard about Palsanafy and from doctors who recommend it. Patient awareness and doctor recommendation are both contributing to prescriptions. - Dr. Scott Struthers(CEO)

Can you provide an update on the launch preparations for paltusotine in acromegaly? What are the key differentiators and global strategy? - Tyler Van Buren (TD Cowen)

2024Q4: The commercial organization is building a strong team, including a VP of Sales. The value proposition of paltusotine is well-received by payers. Efforts are focused on education, market engagement, and supply chain readiness. - Isabel Kalofonos(CMO)

Contradiction Point 5

Payer Value Proposition

It highlights differing views on what aspects of PALSONIFY are most appealing to payers, which can impact pricing strategies and market positioning.

Can you share the number of top prescribers contacted, the addressable acromegaly patient concentration, and doctors' perception of Palsanafy? - Corey Trubenville (LifeSci Capital)

2025Q3: Palsanafy's efficacy and ease of administration are significantly resonating with doctors, leading to prescriptions. - Isabel Kalofonos(CMO)

What features of paltusotine attract payers, and what are your views on generic launches following Cipla's return? - Andy Chen (Wolfe Research)

2024Q4: Generics are seen as next-generation injectables. Paltusotine's features like rapid action, sustained effect, and reduced breakthrough symptoms are exciting for payers. The rapid adherence and efficacy are valued, and the product is transforming the standard of care. - R. Struthers(CEO)