Ascendis Pharma (ASND) investor relations material

Product launch and commercialization

• YUVIWEL received recent FDA approval with a clean label and minimal adverse events; launch is planned for early Q2, with pricing to be announced soon.

• The product differentiates itself with weekly dosing and room temperature stability for up to six months.

• Commercial rollout leverages an established sales infrastructure used for other rare disease endocrine products, targeting both new and existing patients.

• U.S. launch will be followed by international early access programs, with European approval expected later in the year.

• Most patients with the target condition in the U.S. are not currently on treatment, presenting significant market opportunity.

Market dynamics and patient segments

• About 2,600 patients in the U.S. are eligible, with only 30% currently treated; 100 providers manage 55% of these patients.

• Anticipated patient uptake from both those switching from existing therapies and untreated patients, supported by clear FDA guidance on switching.

• Data show benefits beyond linear growth, such as improved leg alignment and muscle strength, which may drive higher treatment rates.

• Engagement with patient groups focuses on addressing comorbidities, aiming to increase penetration similar to higher rates seen in countries like Italy.

Product differentiation and safety

• YUVIWEL’s TransCon technology enables sustained release, reducing risk of hypotension and minimizing injection site reactions compared to daily therapies.

• Safety label includes a class warning for blood pressure changes, but no such effects observed with YUVIWEL in trials.

• Added benefits include addressing comorbidities, which is a key focus for patient advocacy groups.