Viridian Therapeutics Inc "FDA Approval for IV TED with Broad Label – SubQ..."

Research evidence excerpt

Viridian Therapeutics Inc "FDA Approval for IV TED with Broad Label – SubQ..."

c 12/26E

study was run as a post marketing study – so net-net an incremental positive for UBS Cons.

Lumvoa. Hearing impairments is 9% pbo adjusted in the label across both studies for Q1 (0.90) (1.09)

Q2E (1.00) (1.05)

active and chronic. Recall, Tepezza is only 10% pbo adjusted among the Phase II and III in

Q3E (0.80) (1.05)

active TED only. So, the label is relatively similar to Tepezza as expected with no surprises

Q4E (0.71) (0.94)

but VRDN differentiates on 5 infusions being 30 mins vs Tepezza being 8 infusions and 12/26E (3.44) (3.84)

60-90 mins. 12/27E (2.70) (2.25)

12/28E (1.11) 0.06

Launch cadence & pricing: Launch is already underway, and docs are able to prescribe

Michael Yee

Lumvoa right now. Recall much like Tepezza, Lumvoa will also have a ~90 day prior

Analyst

authorization timeframe, which means once patients are written a script, they are not michael.yee@ubs.com

dosed until ~90 days later… which means there will be a ~3-month or one-quarter delay +1-305-536 9101

into when revenues are booked. This is important to note for Q3 and implies minimal

Dina Elmonshed

revenues (though could be some inventory) but should pick up in Q4 and into 2027+. Analyst

Pricing wise, the co is pricing at parity to Tepezza which is estimated ~$360K for patients dina.elmonshed@ubs.com

~70kg on average (and there is limited to minimal discounting too). Pricing at parity +1-212-649 8276

should ensure parity coverage to Tepezza which is 85% of covered lives, but again will

Kyle Yang, CFA

take time 6-9 months for Lumvoa to get on formularies and J code etc. Associate Analyst

kyle.yang@ubs.com

We await more details around patient start forms or launch metrics which co +1-212-713 1458