NEUROCRINE BIOSCIENCES INC earnings calls

INGREZZA Q4 expectations

Q (Philip Nadeau · TD Cowen): Why does the top end of INGREZZA guidance imply a sequential Q4 decline after a strong Q3? Was the $20 million order the only lumpiness or are there Q4 headwinds?

A: Management said Q3 was very strong and they expect similar underlying TRx growth in Q4 in the mid-teens. They noted a seasonal gross-to-net dynamic in Q4 but feel good about guidance moving from $2.7 billion to $2.9 billion and expect strong momentum into 2027.

"It was a really strong third quarter across the board, and we would anticipate in the fourth quarter to have similar underlying TRx growth somewhere in the mid-teens." — Matthew Abernethy (CFO)

VYKAT safety and growth

Q (Paul Matteis · Stifel): Are you comfortable VYKAT will remain a resilient grower after recent safety-related press? Could regulators engage on post-marketing safety reports?

A: Management said they are still integrating VYKAT after the acquisition and expect a return to growth, though it may be delayed. They monitor post-marketing safety closely, are confident in VYKAT XR's benefit-risk profile, and plan R&D Day engagement and a study next year for PWS patients with significant comorbidities to better understand safe use.

"we are very confident in the benefit risk profile that we have for VYKAT XR." — Eiry Roberts

2027 access and net price

Q (Tazeen Ahmad · BofA): How is INGREZZA contracting and access shaping up for 2027, and is net price intact or changing?

A: Management said access and pricing are linked and they expect continued strong coverage into 2027, building on contracting that covered about 70% of Medicare lives in 2025. They expect double-digit volume growth in 2027 and indicated roughly mid- to high single-digit price concessions for 2027 that will be more than offset by volume growth; more detail will come in the new year.

"So when we think about 2027, we do expect that underlying momentum to lead to, again, double-digit volume growth for 2027, and that reinforces really the durability of INGREZZA as a product in TD as well as continued revenue growth." — Kyle Gano (CEO)

VYKAT PWS market size

Q (Kevin Meli · RBC): How big could the PWS opportunity be for VYKAT and have your views on peak opportunity or timelines changed?

A: Management estimated roughly 10,000 to 12,000 PWS patients in the U.S., noted most have hyperphagia but not all and some patients (very young or with comorbidities) may not be appropriate for treatment. They remain convinced of the medication's potential, see it as early in its launch (about 1.5 years), and emphasized the need for provider and patient education and more data.

"we estimate that there's roughly 10,000 to 12,000 patients in the U.S." — Eric Benevich

VYKAT discontinuations vs starts

Q (Brian Skorney · Baird): Are you past the initial launch 'bolus' discontinuations for VYKAT, and should we expect normal discontinuation rates now?

A: Management said they are still learning because the product has been on market just over 1.5 years; an initial bolus of starts increased discontinuations early on. Since then they have seen consistent, steady starts and numerically similar discontinuations to prior quarters, so it's hard to say if Q3 differed — stay tuned.

"Since then, we've seen pretty consistent and steady starts." — Eric Benevich

INGREZZA growth by channel

Q (Anupam Rama · JPMorgan): Which prescriber segments drove INGREZZA's outsized growth — psychiatry, neurology, long-term care?

A: Management said growth potential exists across all prescriber segments and there is still substantial opportunity from underdiagnosed TD patients; only about 10-ish percent of the prevalent TD population is on a VMAT2 inhibitor. They view psychiatry, especially advanced practice providers, as the main growth driver and also see strong, consistent growth in long-term care.

"we see the psychiatry segment as the main growth driver." — Eric Benevich

CRENESSITY growth source

Q (Mario Joshua Chazaro Cortes · Evercore): Is CRENESSITY growth driven by new prescribers or returning prescribers?

A: Management said CRENESSITY growth has been steady with consistent patient adds, favorable reimbursement and strong persistence. Early launch growth was driven by new prescribers and most prescribers still have only 1–2 patients, but depth is increasing and adult endocrinology adoption is rising; roughly half of patients on CRENESSITY are adults.

"most of the growth was driven by new prescribers." — Eric Benevich

567 Phase II meaningful result

Q (Jay Olson · Oppenheimer): For 567 Phase II, what would be a clinically meaningful result on the 12-week neuropsychological battery?

A: Management described the Phase II design: about 135 adults age 50 to 85 with mild to moderate Alzheimer's on stable acetylcholinesterase inhibitors, measuring change from baseline at week 12. The primary endpoint is a neuropsychological test battery composite compared to placebo, and they will consider the totality of data including ADAS-Cog, clinical dementia rating and tolerability.

"we're actually looking at a range of different endpoints in the context of study and looking at a change from baseline for that adjunctive treatment at week 12." — Eiry Roberts

Competitor emraclidine and their program

Q (Phoebe Tan · Jefferies): With competitors increasing emraclidine dose, how do you view dose response and M4 inhibition comparability, and your confidence for your schizophrenia readout?

A: Management said they are focused on their own M4-selective orthosteric agonist, direclidine, and expect topline data from the first short-term study next year with timelines on track. They believe their program could offer patient benefit without some side effects seen with existing products and are watching the landscape but remain focused on their program.

"So we have our M4 selective orthosteric agonist direclidine, which we anticipate top line data from the first short-term study next year, time lines are on track there." — Samir Siddhanti

VYKAT upside and study rationale

Q (Susan Chor · Wells Fargo): Where did the VYKAT upside come from this quarter — pricing, inventory, net adds? And is the planned PWS study aimed at education or label expansion?

A: Management said the upside was net patient adds, not pricing. They said the current label accurately reflects benefit and risk, and the planned study is to expand knowledge, improve education on patient selection, safe titration, monitoring for adverse events, and better understand hyperphagia's behavioral impact; they aim to study patients with other complex conditions too.

"We think the current label really accurately reflects the benefit and risk of VYKAT XR in the population that were studied." — Eiry Roberts

M&A/BD priorities

Q (David Amsellem · Piper Sandler): What are your top business development and M&A priorities into 2027 and which therapeutic areas are you prioritizing?

A: Management said they will stay focused and disciplined, targeting opportunities with differentiated innovative science and strong IP in their areas of expertise (neurology, psychiatry, endocrinology, and soon immunology). Transactions must create shareholder value; they have financial flexibility and do not feel compelled to do a deal immediately but are prepared to act opportunistically.

"What I'd say on the BD focus is that we really want to remain focused and disciplined on future opportunities." — Samir Siddhanti

CRENESSITY persistency and VYKAT dose

Q (Alyssa Larios · Leerink): What were CRENESSITY discontinuation rates in Q3 versus prior quarters and persistency outlook? Also, what's the current VYKAT maintenance dose distribution?

A: Management said CRENESSITY has shown above-average persistency, steady patient adds, favorable reimbursement, and Q3 persistency was consistent with prior quarters. For VYKAT, they guided average maintenance dose around 250 milligrams per patient at this point.

"On VYKAT, I would just guide you to around 250 milligrams is what we're seeing on average per patient at this point." — Matthew Abernethy (CFO)

VYKAT adverse events and IP

Q (So Youn Shim · UBS): Are higher FAERS AEs in 2026 due to more use or higher AE frequency? And what is your confidence in VYKAT IP given recent post-grant actions?

A: Management said patient safety is the primary focus and they have a controlled distribution via a single specialty pharmacy with close contact, education and support to enable safe selection and titration; the label gives guidance on known side effects like hyperglycemia and fluid retention. On IP, they said it's probably too early to discuss specific patent challenges but they feel good about exclusivity into the mid-2040s based on published and issued patents.

"I think it's probably too early to talk about any of the challenges on existing patents." — Kyle Gano (CEO)

Who proposed PWS study

Q (Myles Minter · William Blair): Was the PWS study a result of collaboration with FDA requiring it, or was it your proposal to help use VYKAT XR in this patient group?

A: Management said the study was their proposal developed in collaboration with key opinion leaders to understand the broader population that could benefit beyond the original trials. They are finalizing the design with KOLs including Dr. Jennifer Miller, who has published guidance already used to support community education.

"This was our proposal in collaboration with the several key opinion leaders in the field." — Eiry Roberts

Direclidine Phase III expectations

Q (Sumant Kulkarni · Canaccord): Does Cobenfy's muted launch change the market outlook for direclidine, and what would excite you in Phase III?

A: Management said the bar for Phase III is a positive study and they expect to win on safety and tolerability; their drug is once-daily with no titration and showed limited GI side effects in Phase II. They added the Phase III program is progressing well, DMCs have reviewed safety with no required changes, and they have a low discontinuation rate of 3% or less in the current program.

"we have a low discontinuation rate of 3% or less in our current program." — Eiry Roberts

Obesity programs CRF2 and GGG

Q (Yigal Nochomovitz · Citi): How are the CRF2 (2118) and GGG (1968) obesity programs being developed — will they compete or serve different patients, and what should Phase I show?

A: Management said the lead CRF2 agonist, NBIP-2118, is a subcutaneous at least once-weekly injectable peptide; they will test it in obese healthy volunteers to see if preclinical fat-loss and muscle-sparing profiles replicate in humans. NBIP-1968 (GGG) is a stand-alone or combinable program to pair with 2118 or be a single molecule, reflecting a mix-and-match strategy as the field likely moves to combinations.

"This is a subcutaneous at least a once-weekly injectable peptide that we're developing for obesity." — Kyle Gano (CEO)

Salesforce expansion impact

Q (Truist): How much of recent growth reflects the expanded salesforce and is there further productivity upside?

A: Management said the expanded salesforce contributed to strong growth in Q2 and Q3 but it typically takes a few quarters to see the full impact. They expect more salesforce impact in Q4 and carrying into 2027, contributing to their expectation of double-digit growth next year.

"it takes a few quarters to have the full impact or see the full impact of the expansion." — Eric Benevich

VYKAT 2027 growth timing

Q (Guofang Li · Wolfe): How should we model VYKAT patient starts and discontinuations into Q4 and through 2027 — will sequential growth come early or later?

A: Management said there is a lot of potential and many untreated patients with PWS hyperphagia, but recent external events will somewhat delay the expected growth trajectory. They are continuing education and promotional efforts, and they aim each quarter to have more patients on treatment than the prior quarter.

"Given the recent external events, we do think that it's going to delay somewhat the growth trajectory that we're expecting." — Eric Benevich

569 Phase I needs and dosing

Q (Maddalena Delma Caiati · Guggenheim): For 569 in Alzheimer's psychosis, what do you need to see in Phase I on efficacy and safety to go to Phase II, and how will you handle dosing/titration in older, sensitive patients?

A: Management said it's early and Phase I focuses on safety and tolerability to choose an appropriate dose for Phase II; 569 has been well tolerated to date and they've been able to accomplish the dosing needed to move forward. They noted they will know more after completing the Phase I work.

"A lot of Phase I work, as you know, is focused on understanding safety and tolerability and helping us choose the appropriate dose for a Phase II study." — Eiry Roberts

Why pair CRF2 with GGG and R&D spend

Q (Laura Chico · Wedbush): What's the scientific rationale for pairing a CRF2 agonist with a GGG agonist, and how much R&D spend will you allocate to obesity versus psychiatry programs?

A: Management said they still have unanswered questions about whether CRF2 (2118) works best standalone or combined with an incretin/GGG at lower doses and they will learn early in development. They view obesity programs as a strategic diversification where early studies can provide biomarkers and objective endpoints quickly, allowing efficient go/no-go decisions relative to larger psychiatry investments.

CRENESSITY adult headroom and under-4 study

Q (Poorna Kannan · Needham & Company): What's the headroom for CRENESSITY in the adult population and how much incremental market could the under-4 study capture?

A: Management said there is substantial headroom in adults and about half of patients on treatment are adults; CRENESSITY is only several quarters into launch with north of 15% of classic CAH patients on treatment. They are initiating a study in under-4 patients because early treatment may better control the hypothalamic-adrenal axis and reduce high steroid dosing impacts on growth and development, aiming to expand the label to younger ages.

"we're just initiating our study in the under 4-year-old patient population." — Eiry Roberts

CRENESSITY competition and dosing

Q (Graig Suvannavejh · Mizuho): How do you view competition (Vertex/Crinetics) for CAH and differentiation versus CRENESSITY, and what about BID versus QD dosing?

A: Management said CRENESSITY has set a high bar on efficacy, safety and tolerability with long-term data out to 5 years and positive 2-year results, including physiologic glucocorticoid dosing and biochemical control. They emphasized broad label and multiple formulations, strong demand, and confidence in changing standard of care regardless of competition.

"CRENESSITY has really set a very high bar out there not only for competition, but our own next-generation programs in the pipeline." — Kyle Gano (CEO)

Why discontinue 986

Q (Malcolm Hoffman · BMO): Why was 986 (M4 antagonist) discontinued — safety/tolerability problem or strategic decision?

A: Management said Phase I completed and they assessed pharmacodynamic markers, PK and tolerability; the totality of data did not meet their bar to proceed to a Phase II study in Parkinsonian tremor. They discontinued the molecule during portfolio prioritization and there was no particular safety issue that forced the decision.

"we didn't really meet the bar that we had set ourselves to be willing to go forward into a Phase II study in Parkinsonian tremor." — Eiry Roberts

CRENESSITY glucocorticoid tapering

Q (Samuel Beck · Deutsche Bank): Is tapering glucocorticoids a real-world challenge that could slow CRENESSITY adoption or cap penetration?

A: Management said they view tapering not as an impediment but as the promise of treatment; the process is individualized and they published expert guidance to help clinicians taper safely. They noted many patients can reach physiologic dosing safely without increased adrenal insufficiency, which is encouraging for adoption.

"I don't see it as an impediment to prescribing." — Eric Benevich