$LEGN Legend Biotech
This biotech name has been on my watchlist for some time.
They have just named the former Chief Commercial Officer for Novartis International – Ingrid Zhang – as their new CEO effectively immediately. Ingrid led Novartis’ China business and had held leadership positions at AstraZeneca and Pfizer.
Core to Legend’s thesis is the commercial success of CARVYKTI – a CAR-T cell immunotherapy targeting BCMA (B-Cell Maturation Antigen) which is over-expressed in multiple myeloma, a type of blood cancer that forms in plasma cells.
For patients with relapsed/refractory multiple myeloma, later-line indications can come in the form of CAR-T and/or bispecific TCE (T-Cell Engager) therapies. Doctors tend to reach for CAR-T first since it yields an optimal efficacy and safety profile. Also, the issue with bispecific is that they may result in gene mutations which can impair T cells when they are collected for CAR-T as a next-line indication.
While TCEs have lower production costs and complexity – since they are pre-manufactured and does not require the process flow/interval of extraction, programming and infusion, CAR-T cell therapies such as CARVKYTI is a compelling option since it’s a one-time infusion (compared to TCEs which are typically administered over months or a year) with durable remissions and extended treatment-free intervals.
After years of investments, Legend and J&J (their partner) have ramped enough production capacity to fully meet global demand, with product turnaround time kept within four weeks, manufacturing success rate of 99% and a 97% reliability rate – attesting to the yield and quality of their product.
Also, Legend recently reached a major milestone, posting its first profitable quarter in 2Q 26 (on adjusted net income), which they expect to sustain through 2H 26.
CARVYKTI stats & details:
■ 2Q 26 total net trade sales were at ~$657M (+50% y/y), with U.S. net trade sales growth at +32% and ex-U.S. sales growth at +128%
■ Availability has now reached 348 global sites across 19 global markets with the recent launch in Ireland
■ Peak sales target - for CARVYKTI alone- is estimated to be at least $5B (potentially up to $7B) per year. Underpinning this target is the population of relapsed or refractory myeloma patients in the U.S. (>100,000) and other major markets, with fewer than 10% having utilized a BCMA therapy, which presents a significant growth upside
Now compare this to the stock’s current market cap of $3.4B
As for their pipeline:
1) Autologous therapies
■ LB1908: for relapsed/refractory gastric & pancreatic cancers (met primary endpoint, patient follow-up)
■ LB2102 (targeting DLL-3): for second-line or later (2L+) small cell lung cancer and large cell neuroendocrine carcinoma (met primary endpoint, patient follow-up. Legend has a license agreement with Novartis to develop, manufacture and commercialize this/other potential CAR-T therapies targeting DLL-3
■ LB2401/2402/2403 and LB2502: for relapsed/refractory multiple myeloma (patient follow-up / enrolling)
2) Allogeneic therapies
■ LB2404D/2405: for relapsed/refractory autoimmune diseases (enrolling)
■ LB2302/2303 and LB2406: for relapsed/refractory B-cell non-Hodgkin lymphoma (enrolling)
3) In vivo therapies
■ LB2501 (CD19 and CD20 dual targeting CAR-T): for relapsed/refractory B-cell non-Hodgkin lymphoma (enrolling)
■ LB2503/2505: for relapsed/refractory multiple myeloma (enrolling)
Potential competition:
■ J&J’s Tecvayli + Talvey bispecific TCE
■ Gilead Sciences’ anito-cel, an investigational BCMA-targeted CAR T-cell therapy, which they acquired through the purchase of Arcellx earlier this year
Legend’s arguments against competitive threats:
■ Their alliance with J&J remains robust. And the market growth for CAR-T and TCEs is not a zero-sum game given the large pool of patients in the U.S. and overseas with low penetration rates
■ Gilead/Arcell’s anito-cell is slated for a later-line indication (i.e. fourth-line treatment), compared to CARVYKTI (about 70% of CARVYKTI uses in the U.S. today are for second- to fourth-line patients)