Neurocrine Biosciences' Q3 2025: Contradictions Emerge on Crenessity Launch, Ingrezza Pricing, Market Share, and Sales Force Impact

Date of Call: October 28, 2025

Financials Results

• Revenue: $790M net product sales in Q3, up 28% YOY; INGREZZA $687M; CRENESSITY $98M (up from $53M in Q2)
• Gross Margin: Low-40% range in 2025, down from low-50% range over prior years

Guidance:

• SG&A to increase ~ $150M in 2026 to support expanded INGREZZA and CRENESSITY sales forces
• INGREZZA and CRENESSITY sales-force expansions to be fully completed by end of Q1 (2026)
• Expect current formulary coverage for INGREZZA to carry through 2026
• CRENESSITY gross-to-net expected to be < ~20% and reimbursement >80%
• R&D productivity goal: 4 new Phase I and 2 new Phase II initiations in the year
• Company cash ~$2.1B; capital priorities: revenue growth, R&D (~35% target), BD, then shareholder returns

Business Commentary:

* Strong Commercial Performance: - Neurocrine Biosciences reported net product sales of $790 million in Q3 2025, reflecting 28% year-on-year growth. - This growth was driven by the strong performances of both CRENESSITY and INGREZZA, with CRENESSITY achieving $98 million in its third full quarter and INGREZZA reaching $687 million, marking its third consecutive quarter of record new patient additions.

• Clinical and Pipeline Advancements:
• The company is on track to meet its R&D productivity goals for the year, including the initiation of 4 Phase I studies and 2 Phase II studies.

• This progress is attributed to the advancement of high-quality preclinical programs and the expansion of Neurocrine's early and mid-stage pipeline.

• Sales Force Expansion and Strategy:

• Neurocrine announced an expansion of its sales teams for both INGREZZA and CRENESSITY, aiming to increase its sales footprint by approximately 30%.

• The expansion is to accelerate market development for TD, maximize patient share, and position the company for potential launches of late-stage clinical programs in psychiatry.

• Impact of the Inflation Reduction Act (IRA):

• In response to the IRA, Neurocrine is pursuing strategies to maximize patient share and manage potential impacts on NRx during the 2027 to 2029 period.
• This includes creating an expanded sales force to help navigate potential impacts from the IRA on INGREZZA and to prepare for upcoming launches of new psychiatric medications.

Sentiment Analysis:

Overall Tone: Positive

• Q3 net product sales $790M, up 28% YOY; INGREZZA $687M with record new patient starts; CRENESSITY Q3 $98M with >1,600 patients since launch; management expanding sales forces and targeting R&D productivity (4 Phase I / 2 Phase II) while retaining $2.1B cash and pursuing growth investments.

Q&A:

• Question from Philip Nadeau (TD Cowen): CRENESSITY enrollment forms were lower in Q3 than Q2 — seasonality or early-launch bonus? Any modeling insights?
  Response: Adoption has been steady; Q3 had 540 new starts, >1,600 total; no seasonality detected and launch is on track.

• Question from Paul Matteis (Stifel): How are you thinking about AUSTEDO IRA pricing and implications for INGREZZA gross-to-net and payer dynamics?
  Response: AUSTEDO pricing expected in November; INGREZZA is sticky — plan is to maximize patient starts through 2026 while monitoring varied payer responses.

• Question from Tazeen Ahmad (BofA Securities): Are payers requiring steroid tapering for CRENESSITY coverage and any seasonality heading into Q4?
  Response: Reimbursement hasn't required specific steroid tapering; payers focus on diagnosis and hydrocortisone use; no material seasonality expected.

• Question from Steve (Jefferies): Any payer preference shifts for AUSTEDO XR vs BID and how do you lock INGREZZA pricing through 2026?
  Response: Plans see dose‑creep on AUSTEDO; we've achieved formulary parity and expect current coverage to hold through 2026.

• Question from Mohit Bansal (Wells Fargo): Provide color on the DOJ investigation disclosed in the 10‑Q and timeline.
  Response: Company received a Civil Investigative Demand in August regarding INGREZZA sales/marketing, is cooperating, and has no further material update now.

• Question from Cory Kasimov (Evercore ISI): Status of CRENESSITY adoption at centers of excellence and progress in community endocrinology?
  Response: All ~20 COEs have begun adoption at variable paces; community endocrinologists adoption has been stronger than expected — expansion targets those practices.

• Question from Anupam Rama (JPMorgan): Can you quantify the sales force expansion by segment for INGREZZA and CRENESSITY?
  Response: Overall ~30% increase in sales footprint; majority of hires for INGREZZA (combined Neuropsych team), LTC expanded separately; smaller expansion for CRENESSITY (existing team <50).

• Question from Jay Olson (Oppenheimer): Considering direclidine, are you evaluating Alzheimer's psychosis and will you watch BMS Cobenfy readout for learnings?
  Response: AD psychosis is a potential follow‑on indication; company will monitor BMS Cobenfy data and leverage its muscarinic portfolio to select appropriate molecules.

• Question from Luke Herrmann (Robert W. Baird): For NBI‑770 Phase II readout, what result would support a confirmatory Phase II vs moving to Phase III?
  Response: The 72‑patient Phase II is a signal‑finding study; an encouraging signal would lead to a confirmatory Phase IIb; direct move to Phase III remains possible but less likely without stronger evidence.

• Question from Brian Abrahams (RBC Capital Markets): Can you comment on CRENESSITY persistence and glucocorticoid equilibration for early launch patients?
  Response: Persistence and adherence are strong; most early patients remain on therapy; clinicians are variably tapering glucocorticoids with favorable androgen control.

• Question from Marc Goodman (Leerink Partners): How should we think about CRENESSITY gross‑to‑net going forward?
  Response: Expect CRENESSITY gross‑to‑net to be under ~20% going forward, with reimbursement rates above ~80%.

• Question from Sean Laaman (Morgan Stanley): Neurology vs psychiatry split for INGREZZA — are you prioritizing psych over neuro?
  Response: Neurology is ~15% of volume; psychiatry (including advanced practice providers) is the fastest‑growing focus — psych and neuro teams combined to target growth while keeping LTC separate.

• Question from Yigal Nochomovitz (Citi): With a ~$150M SG&A increase, how will buybacks proceed under the $500M authorization?
  Response: With $2.1B cash and no debt, priority is top‑line growth and R&D (~35% target); buybacks remain possible but bias is toward BD and internal investment.

• Question from Corinne Jenkins (Goldman Sachs): Where do you stand on share of new‑to‑category patients vs AUSTEDO and trend vs a year ago?
  Response: New patient starts are a single‑digit percent of TRx but INGREZZA is capturing the majority of new starts now, driving higher patient share versus a year ago.

• Question from Ashwani Verma (UBS): Given sales force investment and contracts, can INGREZZA grow faster in the medium term than this year?
  Response: VMAT2 market is growing double‑digit; INGREZZA grew ~12% YoY in Q3 and management expects continued robust growth into 2026 with investments.

• Question from Ami Fadia (Needham): For NBI‑770, what absolute change would you view as meaningful and are you thinking about TRD vs adjunctive MDD?
  Response: Study is small so no specific effect‑size threshold was given; positive signal could support either adjunctive MDD development or a TRD pathway similar to SPRAVATO.

• Question from Sumant Kulkarni (Canaccord): IRA impact on patient profile/prescriber types and how many products can the neuropsych team support?
  Response: Existing patients expected to remain on therapy during the 2‑year window; expanded Neuropsych team can support launches of one or both late‑stage psych assets but additional expansion would be needed for primary care reach.

• Question from Yatin Suneja (Guggenheim): Is the 14th‑week ordering dynamic specific to INGREZZA and CRENESSITY inventory status?
  Response: 14th ordering week impact pertains to INGREZZA (approx. one full week's uplift); CRENESSITY inventory build ~ $7M in Q3.

• Question from Myles Minter (William Blair): CRENESSITY new starts fell from 664 in Q2 to 540 in Q3 — warehousing effect and when will you see growth after salesforce expansion?
  Response: Q2 had a bump from open‑label conversions; Q3 weekly enrollments are steady and measured — salesforce expansion expected to accelerate adoption into next year.

• Question from Alexander Nackenoff (Truist): Any shift in pediatric vs adult starts for CRENESSITY and trends in free‑drug program usage?
  Response: Demographics remain skewed younger and female; free‑drug program usage is lower than anticipated — roughly 90% obtain insurance coverage and most pay $10 or less out‑of‑pocket.

• Question from Laura Chico (Wedbush): For valbenazine in dyskinetic cerebral palsy, what constitutes meaningful chorea change and overlap with INGREZZA prescribers?
  Response: Chorea measured using adapted UHDRS proxy; a robust chorea reduction would be meaningful and could support an sNDA; DCP prescriber pool is larger than HD but smaller than TD and the expanded salesforce can cover prescribers if approved.

• Question from David Hoang (Deutsche Bank): You reiterated but did not raise guidance — any other factors for Q4 (seasonality, conservatism)?
  Response: Normalize Q3 by removing the 14th week; typical Q4 sequential growth has been $15–$20M historically; pricing down ~6–7% YoY with no abnormal dynamics expected.

• Question from Evan Seigerman (BMO Capital Markets): What was in the MAHA DTC warning letter for INGREZZA and will it change your commercial plan?
  Response: Company received a similar industry letter; remains committed to responsible DTC advertising and will continue outreach while reviewing content as appropriate — no material change announced.

Contradiction Point 1

CRENESSITY Launch Dynamics

It involves differing perspectives on the expected dynamics of the launch of CRENESSITY, which is critical for revenue forecasting and investor expectations.

Can you provide updates on CRENESSITY's patient dynamics and enrollment trends, and how should we model upcoming quarters? - [Philip Nadeau](TD Cowen)

2025Q3: CRENESSITY launch has been steady, with consistent weekly adoption. The launch was characterized as measured from the outset. - [Eric Benevich](CMO)

Can you explain the discrepancy between the 26% growth and the sequential guidance below 10%? Is this signaling a market shift heading into 2025? - [Paul Matteis](Stifel)

2024Q4: We're very proud of the 7-year record growth of INGREZZA in 2024. Our 2025 guidance of $2.5 billion to $2.6 billion reflects continued growth of the VMAT2 category and external factors such as an increasingly complex payer environment and competitive dynamics. - [Eric Benevich](CMO)

Contradiction Point 2

INGREZZA Pricing Dynamics and Market Position

It involves differing assessments of INGREZZA's pricing dynamics and market position, which are critical for understanding the product's competitiveness and revenue sustainability.

How will AUSTEDO's upcoming price impact INGREZZA, and should we consider the worst-case scenario given current discounting levels? - [Paul Matteis](Stifel)

2025Q3: We expect AUSTEDO pricing details in November. We are preparing for various strategies by health plans and PBMs post-IRS impact, focusing on maintaining INGREZZA's stickiness. - [Kyle Gano](CEO)

Can you explain the rationale for midyear contracting for INGREZZA and its impact on future contracts? - [Brian Abrahams](RBC Capital Markets)

2025Q2: Our strategy is to maximize patient access, and midyear contracting is part of that approach. We believe this sets us up well for 2026. - [Kyle Gano](CEO)

Contradiction Point 3

INGREZZA Market Share and Patient Starts

It involves the share of new patient starts between INGREZZA and AUSTEDO XR, which impacts market positioning and future growth expectations.

What is the percentage of new-to-category or new-to-class patients for INGREZZA and AUSTEDO? - [Corinne Jenkins](Goldman Sachs)

2025Q3: INGREZZA gains the majority of new patient starts now, with strategic focus on maintaining this share post-IRS. - [Eric Benevich](CMO)

What is the market share split between INGREZZA and AUSTEDO XR for new TD patients? - [Tazeen Ahmad](Bank of America)

2025Q1: INGREZZA maintains the majority of prescriptions in TD, but we don't share exact share data. - [Eric Benevich](CMO)

Contradiction Point 4

INGREZZA's Market Share and Competitive Dynamics

It involves differing assessments of INGREZZA's market share and competitive position, which are crucial for understanding the company's growth potential and market standing.

How will AUSTEDO's upcoming price changes impact INGREZZA, and should we consider worst-case scenarios based on current discounting levels? - [Paul Matteis](Stifel)

2025Q3: We expect AUSTEDO pricing details in November. We are preparing for various strategies by health plans and PBMs post-IRS impact, focusing on maintaining INGREZZA's stickiness. - [Kyle Gano](CEO)

Will the 60-40 market share split between INGREZZA and OITO persist amid evolving payer dynamics, considering your guidance suggests a 4-5% market share loss compared to Teva's guidance? - [Akash Tewari](Jefferies)

2024Q4: We'll continue to lead the market with a strong profile in INGREZZA, which remains when considering factors like efficacy, dosing, and formulation advantages. - [Kyle Gano](CEO)

Contradiction Point 5

Sales Force Impact and Timing

It involves the expected impact and timing of the expanded sales force on product growth, which directly affects revenue projections and investor expectations.

Can INGREZZA grow faster with the sales force investment pre-IRS impact? - [Ash Verma](UBS)

2025Q3: INGREZZA grows faster than the VMAT2 market, with continued strong growth anticipated. - [Eric Benevich](CMO)

When will Medicare Part D formulary access affect INGREZZA? What was the sales force footprint growth percentage? - [Ash Verma](UBS)

2025Q1: The sales force expansion was substantial and has started showing benefits. - [Eric Benevich](CMO)