Return Of In-Person Psychiatry Visits Could Lift Neurocrine’s Ingrezza
Only One In Four TD Patients Currently Offered Treatment
Executive Summary
Ingrezza became a $1bn therapy in 2022 despite the pandemic, but Neurocrine expect many more patients are diagnosed and treated if the pandemic eases as hoped.
Neurocrine Biosciences expects sales of its tardive dyskinesia treatment Ingrezza (valbenazine) to climb to $1.25-1.35bn in 2022, but cautions that another nasty surprise in the COVID-19 pandemic could set back progress.
Tardive dyskinesia (TD) is a condition where an individual’s face or body makes sudden and uncontrollable movements, and is caused by use of dopamine receptor blocking drugs prescribed to treat psychiatric or anxiety disorders.
Sales of daily oral therapy Ingrezza have risen rapidly since it was first launched in 2017, and now has blockbuster status thanks to growing levels of antipsychotic drug prescribing. Sales of the vesicular monoamine transporter type 2 (VMAT2) inhibitor reached $301m in Q4 last year, up by 25% on the same period the previous year, producing full-year revenues of $1.1bn, a rise of 8%.
The San Diego-headquartered company also launched Parkinson’s disease treatment Ongentys (opicapone) in the midst of the pandemic in mid-2020, and so became adept at helping doctors to prescribe treatments via telemedicine consultations and raising physician and patient awareness.
Kevin Gorman
Neurocine's CEO Kevin Gorman and his leadership team is hopeful that as COVID-19 moves into an endemic stage during 2022, this will allow more face-to-face appointments.
“As COVID cases go up, psychiatric patient visits decline with a higher mix of visits going virtual. This combination directly impacts TD diagnosis and ultimately treatment rates,” noted chief financial officer Matt Abernethy on its Q4 call with analysts on 11 February.
“The good news is that COVID cases are starting to decline, and we expect site patient visits to increase throughout 2022, leading to a tailwind for Ingrezza in the second half of the year,” but added it was difficult to predict how the pandemic would play out.
Chief commercial officer Erin Benevich explained that telemedicine is still being used at a high rate in psychiatry, with around half of all patient consultations conducted virtually, compared to less than 10% in neurology. The company expects this level to remain high post-pandemic, but wants to see some safeguards introduced, such as a requirement for an in-person visit at least once a year.
The company also spent heavily in 2021 on a salesforce expansion and launched an awareness-raising direct-to-consumer advertising campaign, "TD Spotlight" and believes this will help Ingrezza to return growth to pre-pandemic levels.
Neurocrine does not have the TD market to itself, however, as Teva markets Austedo (deutetrabenazine, also a VMAT2 inhibitor) which is licensed for Huntington’s chorea (HC) as well as TD, and saw its full year 2021 revenues rise by 26% to $802m. SC143805
Neurocrine is now preparing to file its Ingrezza for use in HC with the US Food and Drug Administration in the second half of 2022, following promising Phase III data announced in December.
An estimated 500,000 to 600,000 people in the US suffer from TD, a number that continues to grow in response to rising levels of antipsychotics prescribing.
Neurocrine said that at Ingrezza’s launch five years ago less than 10% of TD sufferers were being diagnosed, but estimate that this has now risen to around 25%, and can rise further.
The company also estimates that once diagnosed, only half of patients are currently offered a VMAT2 inhibitor, leading it to conclude that this number can be raised in the coming years.
The company is also investing in R&D, with 12 mid-to late-stage clinical programs in the pipeline. Key catalysts in 2022 include top-line proof-of-concept Phase II readouts for NBI-827104, a selective T-type calcium channel blocker. Results from a study of its use in essential tremor are expected mid-year, with a second study in continuous spike-wave during slow wave sleep, a form of epilepsy, in the second half of 2022.
The company’s healthy growth profile in neuroscience has seen it named as a likely M&A target for Biogen, which is known to be looking for companies to acquire following its unsuccessful launch of Alzheimer’s drug Aduhelm (aducanumab). (Also see "A Biopharma M&A Bonanza In 2022? Analysts Pick Top Targets And Likely Buyers" - Scrip, 2 Feb, 2022.)
In any case, the company is scanning for in-licensing opportunities. In November, it signed a deal with Sosei Hepatares to licence in several subtype-selective muscarinic M4, M1 and dual M1/M4 receptor agonists. (Also see "Neurocrine Gains Clinical-Stage Schizophrenia Candidates Returned To Sosei By AbbVie" - Scrip, 22 Nov, 2021.)
The most advanced program, HTL-0016878, is a selective M4 agonist and Neurocrine plans to begin Phase II study of it as a potential treatment for schizophrenia later this year.