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Despite Incyte’s topical atopic dermatitis drug getting slapped with a black box warning — and coming in below Wall Street’s expectations for its first quarter on the market — CEO Hervé Hoppenot called the launch “very successful,” pegging a $1.5 billion peak sales estimate in the US.
However, analysts can’t seem to agree on just how realistic that is given challenges with reimbursement — and investors seem to be erring on the side of caution. Incyte’s stock $INCY was down 2.6% on Wednesday morning, pricing in at $68.25 per share.
“Discussions are ongoing with payers regarding potential full coverage/access for the drug, although we believe reimbursement is likely to remain a significant obstacle to this drug reaching blockbuster status,” SVB Leerink analysts said in a note to investors early Wednesday morning.Brian Abrahams
The analysts called the $1.5 billion sales estimate “unachievable amidst tough payer dynamics, patient cost barriers, and high gross-to-nets, which the company increased to 40-50% (formerly 25-50%).”
RBC Capital Markets’ Brian Abrahams, on the other hand, sees massive potential for the drug and says 2022 sales could come in close to $150 million, which is much higher than current consensus estimates of $76 million.
After nabbing approval back in September, Opzelura — a topical formulation of Incyte’s JAK inhibitor ruxolitinib, better known as Jakafi in the US — was prescribed to nearly 19,000 patients in Q4, and about 11,000 tubes were shipped to US pharmacies in January. The drug reeled in around $4.7 million in sales, missing consensus expectations by 42%, SVB Leerink reported.Barry Flannelly
Incyte has inked base rebate agreements with two large group purchasing organizations (GPOs), establishing utilization management criteria and discount rates for about 55% of patients covered under those organizations, according to Barry Flannelly, Incyte’s North America EVP and general manager. For the other 45%, Incyte’s in “active contract negotiations” to remove coverage limitations. It’s also in negotiations with a third major pharmacy benefit manager, Flannelly said.
In Q4, Incyte’s patient support program covered a “vast majority” of prescriptions, putting up the full cost of Opzelura for many patients, Flannelly said. As coverage improves, he expects the utilization of that specific program to decrease, improving the drug’s gross-to-net rate.
“There are millions of AD patients living with uncontrolled disease in the U.S., and there is enthusiasm from both physicians and patients to try a new, nonsteroidal topical treatment with a novel mechanism of action, with the expectation that patients will be able to find relief of their AD symptoms,” Flannelly said.
Most patients are switching to Opzelura from steroids. In the 16th week since launch, Flannelly said Opzelura captured more than 10% of all new-to-brand prescriptions after steroid failures. Pfizer’s Eucrisa came in just above Opzelura, with 13% of prescriptions, although Sanofi and Regeneron’s Dupixent led the pack by a wide margin at 44%. However, Incyte execs hope the topical cream can rival Dupixent, which is administered via injection. In the week ending Jan. 28, 15% of prescriptions were refills, according to Flannelly.
“The number of refills demonstrates the satisfaction that patients and physicians are experiencing and is a very positive indicator of the long-term potential of Opzelura,” he said.
Opzelura was the first topical JAK inhibitor approved in the US. It’s indicated for AD patients aged 12 and up who struggle to control their disease on other prescription creams. However, it also comes with the black box warning seen across the JAK class of drugs, highlighting risks of serious infections, heart attack, stroke or cardiac death.UPDATED: Incyte nabs approval of topical ruxolitinib in atopic dermatitis, but gets slapped with JAK warning
Ruxolitinib has been a key growth driver for Incyte since getting its first approval as an oral treatment for myelofibrosis back in 2011. The drug has continued to rack up label expansions, getting nods for polycythemia vera in 2014 and acute graft-versus-host disease in 2019. In these indications, the drug is marketed as Jakafi in the US and as Jakavi by Novartis elsewhere.
Jakafi sales were up 10% last year, bringing in more than $2.1 billion. Incyte expects to see $2.3 to $2.4 billion in Jakafi sales in 2022, with the help of a relatively new indication in chronic graft-versus-host disease.
Incyte also expects to hear back this spring on its application for the topical version in vitiligo —a condition in which the skin loses its pigment cells — with a PDUFA date of April 18.
“While we forecast the company to have $3.7bn in top-line product sales by 2025 with the majority ($2.9bn) comprised of Jakafi sales, the Jakafi patent expiry magnifies the importance of the Opzelura launch to the investment thesis,” SVB Leerink analysts wrote.
According to Incyte’s 10-K, Jakafi’s earliest anticipated patent expiration is coming up in 2027.