David Huang

David Huang asked about potential learnings from Takeda's commercial launch of oveporexton, expected in Q3, and how its pricing might inform alixorexton's value proposition.

Answer

Richard Pops, CEO, stated that the most interesting unknown is Takeda's pricing, which will set the tone for market receptivity to NT1 drugs. He views Takeda's entry with a premium product as beneficial for Alkermes, which will follow with a broader product offering. Todd Nichols, Chief Commercial Officer, added that they will observe Takeda's positioning (market expansion vs. switch) and that their pricing will absolutely influence Alkermes' pricing and market access strategy.

David Huang asked about potential learnings from Takeda's commercial launch of soticlestat, particularly how their pricing might inform Alkermes' value proposition for alixorexton.

Answer

Richard Pops, CEO, and Todd Nichols, Chief Commercial Officer of Alkermes, stated that Takeda's pricing will be a key unknown, setting the tone for market receptivity to NT1 drugs. They view Takeda's entry with a premium product as positive for Alkermes, which will follow with a broader product offering. They will closely watch Takeda's positioning and pricing to inform Alkermes' own strategy.

David Huang inquired about the expected next steps with the FDA and phase three program design for Elixerextant after the NT2 data release, and also asked for Q4 expectations for Vivitrol.

Answer

Richard Pops, CEO, stated that NT2 data is on track for November, which, combined with Vibrance I NT1 data, will inform the end-of-phase meeting with the FDA, with phase three expected to launch early next year. Todd Nichols, Chief Commercial Officer, noted that Vivitrol's Q4 expectations are based on strong Q3 alcohol dependence (AD) demand, emphasizing continued AD growth for the mature product.

David Huang asked about the expected characteristics and profile of the new pitolisant formulation, how it differs from Pitolisant HD, and if its characteristics lend themselves to MS and related conditions. He also requested a summary of the IP estate for Pitolisant GR, HD, and the new formulation.

Answer

Kumar Budur, Chief Medical and Scientific Officer, explained that the new formulation might offer differentiated PK parameters better suited for treating fatigue in larger indications, with specifics to be determined after the human PK study. He expressed excitement for its potential in broader CNS fatigue indications. Jeffrey M. Dayno, President and CEO, reminded that Pitolisant GR and HD have utility patents filed out to 2044. He noted that the new pitolisant formulation benefits from an issued patent, licensed to the company, extending to 2042, with ongoing formulation work exploring potential alternative modes of administration.

David Huang asked about the expected characteristics and profile of the new pitolisant formulation, how it differs from Pitolisant HD, and if its characteristics lend themselves to MS and related conditions. He also requested a summary of the IP estate for Pitolisant GR, HD, and the new formulation.

Answer

Dr. Kumar Budur, Chief Medical and Scientific Officer, explained that the new pitolisant formulation may offer differentiated PK parameters better suited for treating fatigue in larger indications, with human PK study results to guide next steps. He reiterated excitement for its potential in broader CNS fatigue indications. Dr. Jeffrey Dayno, President and CEO, summarized the IP estate: Pitolisant GR and HD have utility patents filed out to 2044, while the new pitolisant formulation has an issued patent licensed until 2042. He mentioned ongoing formulation work and the potential for other modes of administration, especially for patients with swallowing dysfunction.

David Huang asked about Neurocrine Biosciences' reiterated but not raised guidance, specifically the Q4 outlook, potential seasonal dynamics, and embedded conservatism, considering the extra ordering week in Q3 for INGREZZA.

Answer

Matt Abernethy, Chief Financial Officer, recommended normalizing Q3 to a 13-week basis and then considering a typical sequential growth range of $15 million-$20 million for Q4. He also noted that the year-over-year price decline of 6%-7% seen in Q3 should be consistent in Q4, with nothing abnormal on the pricing side.

David Huang asked about the reiterated guidance, specifically how to think about the Q4 number given the extra week in Q3 for INGREZZA ordering, and if seasonal dynamics or embedded conservatism should be considered.

Answer

Matt Abernethy, Chief Financial Officer, advised normalizing Q3 to a 13-week basis by removing the impact of the 14th week, which was almost a full week of impact primarily for INGREZZA. He suggested modeling Q4 with a sequential growth range of $15 to $20 million, consistent with historical trends. He also noted that pricing should remain consistent, with a 6% to 7% year-over-year decline in Q3 expected to continue in Q4.

David Huang of Deutsche Bank asked about the competitive implications of a competitor raising its guidance for its VMAT2 inhibitor and also inquired about the percentage of CAH patients who are regularly seen in clinics.

Answer

CEO Kyle Gano addressed the competitive question by focusing on INGREZZA's performance, highlighting its strong volume growth and market share gains in total prescriptions. On the CAH market, CCO Eric Benevich reiterated the estimate of over 20,000 prevalent patients in the U.S. and explained that a firm number is difficult to ascertain, as some patients are not managed by endocrinologists and the diagnosis code is not specific to classic CAH.

Speaking for David Begleiter, David Huang from Deutsche Bank asked about concerns that a competitor might adopt the 'Linde playbook' following a management change and whether this could impact industry pricing.

Answer

CEO Sanjiv Lamba asserted that Linde's leadership is built on a decades-long culture and dense operational networks that cannot be easily duplicated. He emphasized that this network density is the key driver of margin improvement and pricing power. Without commenting on specific competitors, he stated that Linde will continue to act as the market leader.

On behalf of David Begleiter, David Huang asked about the significant headcount increase in recent years, its relation to clean hydrogen projects, and potential for cost reductions given that some projects are now on hold. He also asked if the Alberta project contributes to the FY2025 guidance.

Answer

Chairman, President and CEO Seifi Ghasemi clarified that the headcount increase was primarily for engineering on major projects and is largely capitalized, not directly impacting EPS. He noted that development costs are decreasing and SG&A is down year-over-year. He also confirmed that no significant income from the Alberta project is included in the fiscal 2025 guidance.