Release Date: November 06, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Vanda Pharmaceuticals Inc (VNDA, Financial) reported a 23% increase in total revenues for Q3 2024 compared to Q3 2023, driven by the introduction of Ponvory revenue and increased Fanapt revenue.
- The company completed the first phase of its sales force expansion, increasing to 150 representatives, with plans to reach 200 by year-end, supporting the launch of Fanapt in bipolar one disorder.
- Early indicators of commercial progress for Fanapt are encouraging, with a 90% increase in new patient starts compared to Q3 2023.
- Vanda Pharmaceuticals Inc (VNDA) has initiated a second phase of sales force expansion, indicating confidence in continued growth and market adoption.
- The company is actively pursuing new drug applications and clinical trials for expanded indications, such as Miltefosine for schizophrenia and bipolar disorder, and Ponvory for psoriasis and ulcerative colitis.
Negative Points
- Total revenues for the first nine months of 2024 decreased by 1% compared to the same period in 2023, primarily due to decreased Hetlioz revenue from generic competition.
- Vanda Pharmaceuticals Inc (VNDA) recorded a net loss of $14 million for the first nine months of 2024, compared to a net income of $4.9 million for the same period in 2023.
- Operating expenses increased by $21.7 million for the first nine months of 2024 compared to the same period in 2023, driven by higher SG&A expenses and legal activities.
- The FDA denied approval for Tradipitant for gastroparesis, which was a setback for the company, as they believed the application demonstrated substantial evidence of efficacy.
- Ponvory net product sales decreased by 32% in Q3 2024 compared to Q2 2024, attributed to inventory destocking during the transition of distribution responsibilities.
Q & A Highlights
Q: Can you provide more color on what your sales reps are seeing or hearing from the early days of the Fanapt relaunch with the bipolar indication? Are the additional 50 reps necessary to drive growth, and are you seeing a bump in TRX as well as NRX?
A: We have seen a 90% increase in new-to-brand prescriptions (NBRX), which is a lead indicator. This is followed by increases in NRX and TRX metrics. The more reps we add, the more growth we see, indicating that our sales force is not yet optimized in size. We are excited about the potential return on investment from further expansion.
Q: Do you anticipate any impact of Bristol's launch of Caplyta on the interest in prescribing Fanapt?
A: We are excited to see new mechanisms of action introduced for mental disorders. Bristol's Caplyta is approved for schizophrenia, while our focus is on bipolar one disorder. We do not expect a direct negative effect but believe that investments in the space will renew interest in products like Fanapt.
Q: Can you provide a breakdown of the percentage of overall prescriptions for your three marketed products that is constituted by Medicare?
A: For Ponvory, the majority of prescriptions are commercial, with a smaller portion being Medicare and Medicaid. Fanapt has a stronger tilt towards governmental payers, with potentially more than half coming from Medicare and Medicaid. HETLIOZ follows a similar pattern to Fanapt, with a significant portion from governmental payers.
Q: What is the timeline for the Fanapt LAI Phase 3 program, and when might we see top-line data?
A: We have agreed with the FDA on the design of the pivotal study, which is expected to start shortly in Q4 2024. The study could extend beyond two years, given its duration of about 52 weeks, including stabilization and treatment phases.
Q: Can you speak to your general strategy regarding early-stage programs and the potential for partnering or licensing?
A: Our strategy is to maintain a balanced risk development program with projects at different stages. As programs develop, we will assess whether they are better suited for internal development, partnership, or out-licensing. Currently, we are focused on acquiring products like Ponvory to diversify revenue sources and expand indications.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
