Analyst Conference Summary

biotechnology

conference date: February 13, 2024 @ 5:00 AM Pacific Time
for quarter ending: December 31, 2023 (Q4, fourth quarter 2023)

Forward-looking statements

Overview: Continuing rapid revenue growth.

Basic data (GAAP):

Revenue was $1.01 billion, up 10% sequentially from $919 million, and up 9% from $927 million in the year-earlier period.

Net income was $201 million, up 18% sequentially from $171 million, and up 618% from $28 million year-earlier.

Diluted EPS was $0.89, up 17% sequentially from $0.76, and up 585% from $0.13 year-earlier.

Guidance:

2024 Jakafi net product revenue $2.69 to $2.75 billion. Other net product revenues $325 to $360 million.

Conference Highlights:

Hervé Hoppenot, Incyte CEO, said "We delivered a strong 2023 with total net product and royalty revenues of $3.7 billion, increasing 14% versus 2022. In the fourth quarter, we achieved for the first time, a new milestone of $1 billion in total quarterly revenues, driven by the continued growth of Jakafi (ruxolitinib) and the successful launch of Opzelura (ruxolitinib) cream. Throughout 2023, we focused our R&D efforts on high potential programs and believe we are positioned to deliver more than ten high impact launches by 2030."

In February 2024 Incyte bought exclusive global rights to tafasitamab, a CD19 immunotherapy, sold as Monjuvi or Minjuvi, for $25 million.

In Q4 2023 announced INCB100658, a small molecule inhibitor targeting the JAK2V617F mutation, is expected to file the IND by year-end 2023. The mutation is present in 55-60% of myelofibrosis and essential thrombocythemia patients, and in 95% of polycythemia vera patients.

In Q1 2024 Opzelura Phase 2 for hidradenitis suppurativa met its primary endpoint.

In Q4 2023 a BLA was submitted for axatilimab in chronic graft-versus-host disease, with Syndax Pharmaceuticals. Approval is expected in 2H 2024.

In Q1 2024 a Phase 1 study of KRASG12D was statred for patients with advanced metastatic solid tumors with KRAS mutations.

Numerous other updates and planned trials were reported.

Jakafi patent protection now expected to expire towards the end of 2028. But Opzelura protected until 2040.

Product revenue was $ million; royalties $ million; milestone and contract revenue $ million.

Jakafi royalty revenue is from sales by Novartis outside the U.S.

Non-GAAP numbers: Net income $239 million, down 4% sequentially from $249 million, and up 71% from $140 million year-earlier. Diluted EPS $1.06, down 4% sequentially from $1.10, and up 71% from $0.62 year-earlier.

Cash and equivalents ended at $3.7 billion, up sequentially from $3.52 billion. No debt.

Incyte has numerous other trials in multiple therapies and indications underway, plus preclinical agents.

See also Incyte pipeline.

GAAP operating expenses were: cost of product revenue $70 million. $444 million for research and development; $294 million for selling, general and administrative expenses; $3 million collaboration cost sharing; and a $15 million loss for change in value of a contingent consideration. Total costs $826 million. Leaving income from operations of $187 million. Interest and other income was $50 million. Unrealized loss on investment was $34 million. Income taxes $70 million.

Q&A Selective Summary:

Jakafi possible inflection point, combinations? Leader in myelofibrosis. Pelagressif (sp? Maybe BETi or ALK2i) with Jakafi could appeal to physicians.

Jakafi XR? Novartis could co-develop XR if they wish, for outside the US. Rux XR needs more data, a two year process.

Povorcitinib for HS positioning? We have outstanding efficacy data. JAK1 specific with a long half life. Trial enrollment is going well. In Prurigo N we are showing strong relief from itching and then resolution.

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