Vanda Pharmaceuticals Inc. Q4 FY2024 earnings call

Management Statement and Operational Highlights

• Fanapt: Approved for acute treatment of bipolar I disorder in Q2 2024. Q4 2024 new patient starts increased over 160% vs Q4 2023, net product sales up 18%. Expanding sales force to 300 representatives. Started direct-to-consumer advertising in Jan 2025. Initiated phase three program for long-acting injectable formulation. Identified benefit in treating hypertension with Fanapt.
• Vantrela: Expected to submit new drug application for acute bipolar I disorder and schizophrenia to FDA in Q1 2025. Initiated phase three clinical study for adjunctive treatment of major depressive disorder in Q4 2024.
• Hetlioz: Ongoing clinical programs in pediatric insomnia and delayed sleep phase disorder. MAA for Smith-Magenis syndrome pending with EMA. Continuing pursuit of approval for sleep-onset insomnia and jet lag.
• Ponvory: Commenced commercial launch in Q3 2024. NDA submissions for psoriasis and ulcerative colitis accepted by FDA in Q4 2024.
• Imsidolimab: Entered exclusive global license agreement with Anaptis in Feb 2025. Plan to submit BLA and MAA for generalized pustular psoriasis in 2025.
• Early-Stage Programs: VKW765 in clinical development for acute performance anxiety. VCA894A's IND application accepted by FDA. VGT1849A granted orphan drug designation.

Segment Performance

• Full Year 2024: Total revenues were $198.8 million, a 3% increase from 2023. Fanapt net product sales were $94.3 million (4% increase from 2023), accounting for approximately 47.4% of total revenues. Hetlioz net product sales were $76.7 million (23% decrease from 2023), accounting for approximately 38.6% of total revenues. Ponvory net product sales were $27.8 million, accounting for approximately 14% of total revenues.
• Fourth Quarter 2024: Total revenues were $53.2 million, a 17% increase from Q4 2023. Fanapt net product sales were $26.6 million (18% increase from Q4 2023). Hetlioz net product sales were $20 million (5% decrease from Q4 2023). Ponvory net product sales were $6.5 million (11% increase from Q3 2024)

Guidance

• 2025 Fanapt total revenues expected between $210 million and $250 million.
• Not providing 2025 cash guidance at this time.
• Targeting annual revenue in excess of $750 million for psychiatry portfolio by 2030, assuming approvals of Vantrela and Fanapt LAI. Targeting total annual revenue in excess of $1 billion by 2030.

Risks

• IRB objection to placebo-controlled design for Fanapt long-acting injectable for schizophrenia maintenance may impact study progression.
• Medicare benefit redesign may negatively impact gross-to-net for Medicare payer segment of products.
• Continued generic competition may negatively impact Hetlioz sales.
• Uncertainties in clinical trial design and regulatory approvals for various programs.

Question and Answer

Q: For Fanapt, where is traction coming from and about the 300-rep sales force?

A: Traction is from prescribers of bipolar disorder patients. The 300-rep sales force is to compete, with a measured DTC approach evaluating ROI.

Q: On Vantrela's phase three MDD study, rationale?

A: Experience with Fanapt and iloperidone suggests once-a-day administration may be effective in MDD, leveraging pharmacokinetics and patient tolerability.

Q: On 2030 guidance, what compelled providing it and breakdown of 750M psychiatry revenue?

A: Compelled by progress and potential approvals. 750M includes Fanapt growth, Vantrela approvals, and Fanapt LAI, with Vantrela expected to have favorable economics.

Q: On Hetlioz sales excluding generics?

A: No breakout by geography or indication provided