Vanda Pharmaceuticals (VNDA) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Recent product approvals and launches

• Two new drug approvals: NEREUS for motion sickness and BYSANTI for bipolar and schizophrenia, with NEREUS launched and BYSANTI launch expected by year-end.

• Five commercial products now form the core portfolio, with a focus on revenue growth and product diversification.

• BYSANTI is positioned as a key growth driver, leveraging a switch strategy from Fanapt, with pricing advantages due to Medicaid reset and favorable gross-to-net dynamics.

• NEREUS is being promoted through both direct-to-consumer and sales force channels, with early market feedback and a strategy modeled after previous successful launches.

• Advertising campaigns focus on sports programming for higher engagement and brand recognition, laying groundwork for future product uptake.

Pipeline and clinical development

• Four phase III programs are expected to yield results soon: HETLIOZ (DSPD), NEREUS (nausea/vomiting and GLP-1), VQW-765 (social performance anxiety), and BYSANTI (MDD).

• BYSANTI's phase III MDD trial results are now expected in the first half of next year, with once-daily dosing as a potential differentiator.

• A long-acting injectable (LAI) version of Fanapt is in phase III for schizophrenia, with potential for a BYSANTI LAI in the future.

• Imsidolimab for generalized pustular psoriasis has an upcoming PDUFA date, representing a potential sixth commercial product.

Strategic priorities and revenue outlook

• Diversification across therapeutic areas is a core principle to mitigate risk and drive growth.

• The BYSANTI switch strategy is expected to be the main revenue driver, with Fanapt's LOE approaching in 2027 and a focus on transitioning patients.

• Psychiatry franchise revenue is targeted to reach $750 million by 2030, contingent on BYSANTI's success, MDD label expansion, and LAI launch.

• NEREUS's GLP-1 indication is seen as a significant future opportunity, addressing unmet needs in managing GI side effects of GLP-1 therapies.

• New product contributions are expected to build on the foundation set by Fanapt and BYSANTI, with NEREUS and pipeline assets offering additional upside.