With generic competition heating up, Vas Narasimhan outlines Novartis' growth plans at R&D day
Thursday marks Novartis’ annual R&D day, and with it comes CEO Vas Narasimhan’s attempt to spotlight the company’s pipeline strategy and emerging stars.
The biggest question entering Thursday’s presentation dealt with how the big biopharma will make up revenues from upcoming generic competition — Novartis says within the next five years, generics will eat away roughly $9 billion in sales. To offset this, Narasimhan outlined a strategy for 4% growth or higher until 2026, focusing on six key medicines he believes will see multibillion dollar profits during this time.
Topping the list are approved drugs Cosentyx and Entresto, which have already proved big money-makers for Novartis. The company expects Cosentyx to bring in peak sales of more than $7 billion, up from an annualized $5 billion current projection, and Entresto to top $5 billion, up from $3.7 billion annualized third quarter sales.
Novartis also expects more growth out of Zolgensma, the one-time gene therapy that’s earned the dubious title of most expensive drug in the world. At more than $2 million a pop, Zolgensma had seen flagging sales due to a two-year FDA hold on trials for an intrathecal delivery method, causing Novartis to shutter a manufacturing facility and lay off 400 staffers.
There’s additional focus on two newer medicines Novartis hopes can break into the blockbuster ranks: Kisqali and Kesimpta. Though Kisqali was first approved four years ago, Novartis saw significant growth this past quarter and now expects it should approach the $1 billion sales mark this year.
Rounding out the top six, however, is a drug that’s seen its fair share of setbacks: inclisiran. After acquiring the drug in its $9.7 billion acquisition of MedCo, Novartis received a surprise CRL in late 2020, throwing the drug’s launch into question. Novartis is now targeting a Jan. 1 PDUFA date and has since seen inclisiran approved in almost 50 other countries.
For the longer term, Novartis highlighted a horde of mid-to-late stage pipeline assets that it thinks could one day also be big sales drivers. Among such drugs is the radioligand candidate Lu-PSMA-617, acquired for $2 billion and currently expected to launch in 2022, Novartis says. Earlier this year, the company showed off “groundbreaking: data for the program at #ASCO21.
Novartis grouped Lu-PSMA-617 in its “high strength” evidence umbrella, signifying it’s expecting big things as the radiopharma market begins to take shape in earnest.
Also in this group are other filings for its approved medicines, iptacopan and ligelizumab. Narasimhan highlighted both of these candidates during last year’s R&D day as likely slam dunks of future growth, and both appear on track to remain that way in Novartis’ projections. Iptacopan is expected to be a star kidney drug while Novartis has positioned ligelizumab as a successor to Xolair.
Where Novartis sees only “moderate” strength of evidence are two programs that were once expected to provide solid footing, though. Narasimhan classified pelacarsen and canakinumab as drugs that could see multibillion-dollar sales numbers but are a bit riskier. Pelacarsen is an antisense oligonucleotide being developed for the reduction of lipoprotein(a), whereas canakinumab, an IL-1 inhibitor, saw its future thrown into question after failing a lung cancer study in October.
And Novartis didn’t project any sort of revenue for another oft-touted program in iscalimab after scuttling a trial in September for the candidate once thought to be a leader in the company pipeline.
Lastly, Narasimhan outlined his three “Wild Card” picks — down from five last year — that are risky but potentially hugely rewarding programs. All three were listed in 2020 as Wild Cards, and they are:
- LNA043, an osteoarthritis candidate. It’s currently in Phase IIb studies and Novartis expects a filing here in 2026.
- NIS793, a program going after the TGF-beta pathway inhibition and microenvironment modulation in solid tumors, also listed as a 2020 Wild Card. This candidate, in Phase II/III studies right now, has potential as a first-line pancreatic cancer drug, Novartis says. Filings are expected as early as 2025.
- CSJ117, an inhaled TSLP inhibitor. Novartis touts this drug as possibly the first inhaled biologic directly targeting airways at the site of TSLP expression. A Phase II readout is expected in 2023, an ostensible delay from last year’s 2022 projection.