Y-mAbs Therapeutics (YMAB) Canaccord Genuity 44th Annual Growth Conference & Private Company Showcase 2024 summary

Commercial performance and expansion

• DANYELZA achieved $22 million in Q2 2024 sales, totaling $42 million for the first half of the year, with full-year guidance set at $87–95 million, representing 5–15% year-over-year growth.

• Significant market expansion is underway, with launches in China, Hong Kong, Brazil, and Mexico, and ongoing discussions for further registrations globally.

• Ex-US sales are expected to grow as new partnerships mature, and a patient-named access program is available in Europe.

• Domestic distribution is steady and patient-specific, while international markets experience batch-based, variable ordering patterns.

• Royalty and profit-sharing revenue volatility is expected to decrease as international markets stabilize.

Pipeline development and clinical updates

• DANYELZA is being evaluated in additional indications, including adult neuroblastoma, Ewing sarcoma, and second-line osteosarcoma.

• An osteosarcoma study at Memorial Sloan Kettering showed a 37% response rate (14/45 patients), with pivotal trial planning underway.

• Additional trials are ongoing in Ewing sarcoma and triple-negative breast cancer.

• SADA platform clinical programs include GD2-targeted (1001) and CD38-targeted (1201) radioimmunotherapies, with the first-in-human CD38 trial site activated and more sites planned.

• Preliminary safety and tumor-targeting data for GD2-SADA are expected by late 2024 or early 2025.

SADA platform technology and differentiation

• SADA enables in vivo assembly of the radiopharmaceutical, separating the drug and isotope until administration, improving logistics and shelf life.

• The platform is isotope-agnostic, supporting a range of isotopes (e.g., lutetium, actinium, lead) via proprietary linkers.

• SADA's mechanism allows for functional imaging and targeted delivery, reducing off-target toxicity and leveraging existing infusion infrastructure.

• The approach addresses logistical challenges by eliminating the need for centralized radiopharmaceutical manufacturing.

• The platform supports both diagnostic and therapeutic applications, including PET imaging and alpha therapies.