Release Date: August 01, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Neurocrine Biosciences Inc (NBIX, Financial) reported a 32% year-over-year growth in Ingressa sales, reaching $580 million in Q2 2024.
- The company raised its 2024 Ingressa net sales guidance to a range of $2.25 to $2.3 billion, up from the previous range of $2.1 to $2.2 billion.
- Neurocrine Biosciences Inc (NBIX) received priority review for Crenesifon, with a PDUFA date set for late December, indicating potential for a new blockbuster drug.
- The company has a robust preclinical and clinical pipeline, including promising data for its AMPA modulator in major depressive disorder and multiple new compounds entering the clinic.
- Neurocrine Biosciences Inc (NBIX) is expanding its sales force and investing in direct-to-consumer advertising, which has historically shown positive ROI and propelled Ingressa to new levels.
Negative Points
- No new information was provided on the lupivextrastat or NBI568RM trials, as both remain blinded and databases are not locked.
- The company is facing increased SG&A expenses, including a $15 million non-GAAP impairment charge associated with vacating office space.
- Despite the positive outlook, the company is not yet in a position to provide official financial guidance for 2025.
- There is still a significant portion of the target market for Ingressa that remains untapped, with two-thirds of patients with tardive dyskinesia not yet diagnosed.
- The company faces the challenge of navigating the FDA review process for Crenesifon, with no adcom meeting planned but the possibility of one being scheduled.
Q & A Highlights
Q: Could you review the data from the healthy volunteer study for NBI 568, including muscarinic side effects, cardiovascular effects, and potency to the target?
A: We had a broad range of preclinical and phase one data that made us confident in the safety and tolerability of the doses taken into the clinic. The phase two study will provide more insights into the efficacy and tolerability of the molecule in schizophrenia. (Eiry Roberts, Chief Medical Officer)
Q: What are the key levers for driving growth for the Ingresa guidance range in terms of physician segments?
A: All three business segments (psychiatry, neurology, long-term care) are growing nicely. Continued efforts in raising awareness, educating around TD, and driving recognition and diagnosis will support growth. (Eric Benevich, Chief Commercial Officer)
Q: What justifies increasing the size of your sales force for Ingresa?
A: The number of TD treaters has continued to grow, and expanding the sales force will help meet the needs of our customers. Previous expansions have shown positive ROI within a couple of quarters. (Eric Benevich, Chief Commercial Officer)
Q: How do you determine if patients can dose up to another cohort from a safety perspective in the adaptive study for NBI 568?
A: The dose chosen for the next cohort is based on tolerability reviewed by an independent group. Patients do not titrate within the study; new cohorts start at the recommended dose. (Eiry Roberts, Chief Medical Officer)
Q: Can you share your long-term vision for Neurocrine as you step into the leadership role?
A: We will continue executing the strategic plan, focusing on organic growth, disease modification, and curative therapies. We aim to advance our robust pipeline and maintain financial flexibility to bring new differentiated medicines to patients. (Kyle Gano, Chief Business Development and Strategy Officer)
Q: How should we think about gross-to-net dynamics this quarter and for the second half of the year?
A: Growth this quarter was largely driven by volume, with a bit of improvement from gross-to-net sequentially from Q1 to Q2 in the low single-digit range. Nothing significant to flag for the second half of the year. (Matthew Abernethy, Chief Financial Officer)
Q: What are your thoughts on the ACTH antagonist mechanism in relation to Chronesser font?
A: It's encouraging to see new approaches in the CAH space. We are focused on bringing Chronesser font forward, navigating the FDA process, and aiming to make a significant difference in patients' lives. (Eiry Roberts, Chief Medical Officer)
Q: What needs to happen to provide peak revenue guidance for Ingresa?
A: We do not provide long-term peak sales ranges. The market continues to exceed expectations, and we have conviction behind continued investment in Ingresa. (Matthew Abernethy, Chief Financial Officer)
Q: How will market education impact the launch of Chronesser font?
A: Centers of Excellence will be important, but we also need to reach community endocrinologists. We are engaged in educational initiatives and profiling future customers to ensure a strong launch. (Eric Benevich, Chief Commercial Officer)
Q: Based on the safety profile from the SOSE study, what are the potential opportunities for NBI 568 beyond schizophrenia?
A: We are focused on the data from the Phase 2 study. There are many opportunities based on the nature of the data, and we will consider all of them fully. (Eiry Roberts, Chief Medical Officer)
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
